A mesh device for tissue ligation and a ligation device system

Abstract

The present invention provides a mesh device and a ligation device system for tissue ligation, wherein the mesh device for tissue ligation comprises a support module, a mesh bag and a connection module, wherein the support module comprises a support ring, a skirt and at least one guide rod, wherein the skirt covers the support ring, and the proximal end and the distal end of the guide rod are respectively provided with a first bending portion and a second bending portion, wherein the first bending portion and the second bending portion are bent to the same side of the guide rod, and 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 the circumferential direction through the connection module. The present invention improves the radial supporting force required for the mesh bag to capture the target tissue during the tissue ligation process, avoids the mesh bag from slipping off the target tissue during the ligation process, improves the success rate of tissue ligation, and increases the stability of the ligation device system.

Description

Technical Field

[0001] The invention belongs to the field of medical devices and relates to a mesh device for tissue ligation and a ligation device system. Background Art

[0002] At present, the main treatment methods for tumors or soft tissues that cannot be directly removed from the human body are clamping and ligation. The device used for clamping has a similar shape to a clip and is usually made by processing or injection molding. Due to the fixed shape, the clamping force is usually relatively fixed. However, due to the large individual differences among people, this relatively fixed clip has poor adaptability and the clamping effect is not stable. The devices used for ligation are generally divided into two categories. One type of device is used in conjunction with tools such as endoscopes and laparoscopes to provide a visual field, and ligation is performed by suture or knotting. This method relies on the operator's operability, and the ligation effect is not stable; the other type of device is to locate and capture the target tissue through atrial septal puncture, and then use a percutaneous puncture loop for ligation, but the end of this type of device close to the target tissue is often designed to be soft, with insufficient support, and it is easy to slip off the target tissue. At the same time, the connection between the loop and the push device will deflect, which increases the difficulty for the operator to obtain the target tissue, and there are stability problems in operation. In addition, the processing technology of the above two types of ligation devices is difficult and costly, and there are multiple entry and exit points, which makes the operation complicated, easily causes intraoperative problems, and affects the perioperative treatment effect.

[0003] Therefore, considering the convenience of surgery and the stability of ligation, it is necessary to develop a device system for tissue ligation that has high support force, simple processing, and stable release. Summary of the invention

[0004] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a mesh device and a ligation device system for tissue ligation, which improves the radial supporting force of the front end, is more conducive to opening the space around the target tissue, and solves the problem of front end rotation during the process of capturing the target tissue through a double bending design. At the same time, it can also avoid the problem of the mesh slipping off the target tissue during the ligation process, thereby improving the success rate of tissue ligation and increasing the stability of the system.

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

[0006] In a first aspect, the present invention provides a mesh device for tissue ligation, the mesh device for tissue ligation comprising a support module, a mesh bag and a connection module, the support module comprising a support ring, a skirt and at least one guide rod, the skirt covers the support ring, the proximal end and the distal end of the guide rod are respectively provided with a first bending portion and a second bending portion, the first bending portion and the second bending portion are bent to the same side of the guide rod, and 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 the circumferential direction through the connection module.

[0007] The net device provided by the present invention uses a support ring to support and fix the net bag, thereby increasing the radial support force required for the net bag to capture the target tissue during the ligation process, and solving the problem of the net bag slipping off the tissue during the ligation process; the guide rod is bent twice to avoid the problem of the net bag rotating, which is convenient for capturing the target tissue, and only one channel is used to achieve a single entry and exit, without the need to manage multiple entry and exit points, thereby improving the convenience of the operation. The support ring has a ring contraction function, which can further fully close the left atrial appendage, improve the success rate of tissue ligation, increase the stability of the system, and prevent thrombosis, reducing the risk of stroke, hypertension and potential hypotension.

[0008] The mesh device of the present invention can be delivered to the vicinity of the left atrial appendage by minimally invasive (e.g., through a small incision above, below or through the chest, 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, mini-sternotomy, thoracotomy, thoracoscopy, etc.) methods.

[0009] It should be noted that the shape of the support ring in the present invention includes all surrounding shapes and is not limited to a circle. It can also be a rectangle, an ellipse or an irregular polygon, etc. The present invention does not make any specific limitation on this.

[0010] It should also be noted that the proximal end in the present invention refers to the end close to the target tissue, and the distal end refers to the end of the operator.

[0011] As a preferred technical solution of the present invention, the support ring is a single-ring structure or a multi-ring structure.

[0012] The support ring is made of memory metal, biocompatible plastic metal or elastic metal.

[0013] The support ring is an open ring structure or a closed ring structure.

[0014] The support ring is non-retractable or retractable along the circumferential direction.

[0015] The support ring of the present invention, as the main structure of the net trap device, has a strong supporting force, can support the net bag to open smoothly in the body, and prevent the net bag from slipping off the target tissue after trapping the target tissue. Compared with the support structure of the traditional polymer tube or C-shaped ring, the radial supporting force of the support ring of the present invention increases exponentially, which is more conducive to opening the space around the tissue. At the same time, it also has a ring contraction function to prevent unnecessary deflection during the trapping process.

[0016] As a preferred technical solution of the present invention, 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 is bent, extended to the distal end and then bent again to form at least one guide rod.

[0017] The support module described in the present invention can adopt an integrated molding structure, first forming an open support ring at the proximal end, and then bending at least one end of the open end once, extending toward the distal end and bending a second time to form a guide rod, which effectively simplifies the structure of the support module.

[0018] As a preferred technical solution of the present invention, the first bending portion and the second bending portion are independently bent in circular arcs.

[0019] The bending angles of the first bending portion and the second bending portion are the same or different.

[0020] The bending angle of the first bending portion is 5~175°, for example, it can be 5°, 10°, 15°, 20°, 30°, 40°, 45°, 60°, 80°, 90°, 100°, 120°, 130°, 150°, 170° or 175°, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0021] The bending angle of the second bending portion is 5~90°, for example, it can be 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 60°, 70°, 80° or 90°, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0022] The guide rod is made of memory metal, biocompatible plastic metal or elastic metal.

[0023] When the number of the guide rods is at least two, two adjacent guide rods are parallel to each other or intersecting in parallel.

[0024] As a preferred technical solution of the present invention, the skirt includes a main body and a connecting portion, the main body circumferentially wraps the support ring, the connecting portion extends toward the net bag, and at least one connecting hole is circumferentially provided on the surface of the connecting portion.

[0025] The skirt is formed by sewing, knitting, weaving or braiding.

[0026] The skirt material includes high molecular polymer or animal pericardium.

[0027] As a preferred technical solution of the present invention, the connection module includes a first connection component and a second connection component.

[0028] The first connecting assembly detachably connects the net bag and the supporting module along the circumferential direction.

[0029] The second connecting component detachably connects the net bag and the supporting module through the connecting hole of the skirt connecting portion, and the second connecting component at least connects a portion of the surface of the net bag away from the guide rod and the connecting hole.

[0030] It should be noted that the present invention uses the axis of the net bag opening as the dividing line, and the half of the net bag close to the guide rod is recorded as the upper half, and the half away from the guide rod is recorded 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 and the connecting hole, and is at most fixed along the circumference of the net bag and does not exceed the corner between the lower half and the upper half.

[0031] As a preferred technical solution of the present invention, the first connecting component and / or the second connecting component includes at least one of a threaded connecting member, a wedge connecting member, a pin connecting member and a key connecting member.

[0032] The first connecting component and / or the second connecting component are made of silk, elastic metal wire or polymer material.

[0033] The present invention can realize the step-by-step release of the net bag during application. After the first connecting component is disassembled and released, the second connecting component can still remain connected to the support module, which solves the problem of the net bag slipping from the target tissue during ligation, improves the success rate of tissue ligation, and increases the stability of the system.

[0034] As a preferred technical solution of the present invention, a ligation and tightening rope is provided on the net bag.

[0035] The net bag is a three-dimensional woven body with hollow grids, and the ligation and tightening ropes are cross-threaded between the hollow grids along the circumferential direction of the net bag opening.

[0036] At least one waist tightening rope is arranged along the circumference of the middle part of the net bag.

[0037] The ligature tightening rope and the waist tightening rope are both arranged for unidirectional sliding.

[0038] The shape of the hollow grid is rectangular, prism-shaped or honeycomb-shaped.

[0039] The ligation and tightening rope in the present invention does not need to be integrally braided and fixed with the net bag, and only needs to cross through the mesh of the net bag in the circumferential direction at one end of the net bag opening, thereby reducing the tissue gap and reducing the difficulty of braiding the net bag.

[0040] In a second aspect, the present invention provides a ligation device system, which includes a conveying device and the mesh device for tissue ligation described in the first aspect, wherein the conveying device is connected to a supporting module of the mesh device.

[0041] As a preferred technical solution of the present invention, the conveying device includes a push catheter, and a plurality of independent lumens are provided in the push catheter, and the plurality of lumens are used to movably connect the support ring, the connection module and the net bag respectively.

[0042] The push catheter in the present invention is used to deliver the mesh device to the left atrial appendage and to release and withdraw the mesh device after ligation.

[0043] The numerical range described in the present invention not only includes the point values ​​listed above, but also includes any point values ​​between the above numerical ranges that are not listed. Due to space limitations and for the sake of simplicity, the present invention no longer exhaustively lists the specific point values ​​included in the range.

[0044] Compared with the prior art, the present invention has the following beneficial effects:

[0045] The present invention provides a net device and a ligation device system for tissue ligation, which improve the radial supporting force required for the net bag to capture the target tissue during the ligation process, solve the problem of the net bag slipping off the target tissue during the ligation process, and avoid unnecessary deflection during the capturing process. The left atrial appendage can be fully closed, and the success rate of tissue ligation is improved. At the same time, the stability of the system is increased, the processing is simple, the cycle is short, and the cost is reduced and the efficiency is increased. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 A schematic structural diagram of a mesh device for tissue ligation provided in Example 1-1 of the present invention;

[0047] Figure 2 A side view of a mesh device for tissue ligation provided in Example 1-1 of the present invention;

[0048] Figure 3 A rear view of the mesh device for tissue ligation provided in Example 1-1 of the present invention;

[0049] Figure 4 For the present invention Figure 1 The enlarged view of point A in the middle;

[0050] Figure 5A schematic diagram of the structure of the skirt provided in Example 1-1 of the present invention;

[0051] Figure 6 A schematic diagram of the structure of the net bag provided in Example 1-1 of the present invention;

[0052] Figure 7 A schematic diagram of the structure of the support ring provided in Embodiment 1-2 of the present invention;

[0053] Figure 8 A front view of a support ring provided in Embodiment 1-2 of the present invention;

[0054] Fig. 9 A schematic diagram of the support ring provided in Example 1-2 of the present invention after shrinking and tightening;

[0055] Fig.10 A side view of the support ring provided in Example 1-2 of the present invention after shrinking and tightening;

[0056] Fig.11 A schematic diagram of the structure of the net bag provided in Embodiments 1-3 of the present invention;

[0057] Fig.12 A schematic diagram of the structure of the ligation device system provided in Example 2-1 of the present invention;

[0058] Fig.13 A schematic diagram of the tissue ligation process provided in Application Example 1 of the present invention;

[0059] Fig.14 A schematic diagram of tightening the net sleeve device provided in Application Example 1 of the present invention;

[0060] Fig.15 This is a schematic diagram of the structure of the ligation device system provided in Comparative Example 2-1 of the present invention.

[0061] Among them, 100-net device; 1-support ring; 101-slide rail; 2-guide rod; 201-first bending portion; 202-second bending portion; 3-skirt; 301-main body; 302-connecting portion; 303-connecting hole; 4-net bag; 401-ligation and tightening rope; 402-waist tightening rope; 51-first connecting component; 52-second connecting component; 300-net. DETAILED DESCRIPTION

[0062] It should be understood that, in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0063] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a sewed connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0064] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0065] In a specific embodiment, the present invention provides a net device for tissue ligation, comprising a support module, a net bag and a connection module, wherein the support module comprises a support ring, a skirt and at least one guide rod, wherein the skirt covers the support ring, and the proximal end and the distal end of the guide rod are respectively provided with a first bending portion and a second bending portion, wherein the first bending portion and the second bending portion are bent toward the same side of the guide rod, and the first bending portion is connected to the support ring; at least one end of the net bag is provided with an opening, and the open end of the net bag is detachably connected to the support ring along the circumferential direction through the connection module. The support ring supports and fixes the net bag along the circumferential direction, on the one hand, it can open the space around the target tissue so that the net bag can cover the target tissue, and on the other hand, when the ligature is tightened, the support ring can follow the ring contraction and tightening to prevent the net bag from slipping off the target tissue, and the two ends of the guide rod are bent to constrain the free ends in multiple directions to prevent the proximal end of the net bag from rotating.

[0066] Specifically, the shape of the support ring includes all surrounding shapes, and is not limited to a circle, and may also be a rectangle, an ellipse or an irregular polygon, etc., which is not specifically limited in the present invention.

[0067] In some embodiments, the support ring is a single-ring structure or a multi-ring structure. When the support ring adopts a multi-ring structure, a slide rail with a through lumen opened inside can be used for connection. In order to realize the function of the support ring being retracted into the sheath, and being released by the sheath in the body and opened, the material of the support ring is memory metal, biocompatible plastic metal or elastic metal. The memory metal includes but is not limited to nickel titanium, titanium alloy, cobalt-chromium alloy or stainless steel commonly used in the art. The plastic metal can adopt a metal frame made of biocompatible metal known to those skilled in the art or a rigid metal tube cut by laser. The elastic metal can adopt a flexible spring tube known to those skilled in the art, and the inner cavity of the flexible spring tube is provided with a reinforcing wire with a memory function having a certain supporting force.

[0068] In some embodiments, the support ring is an open ring or a closed ring structure. The support ring is non-retractable or retractable along the circumferential direction. The shape of the support ring is circular, rectangular, elliptical or irregular polygonal. The support ring serves as the main structure of the net device, is designed to be circumferentially ring-shaped, and can be open or closed. The size and shape of the ring can be adaptively adjusted according to the needs of technical personnel in the field. The support ring can support the net bag to open smoothly in the body, and provide strong support for the net bag to capture the target tissue, and has a ring contraction function to prevent unnecessary deflection.

[0069] In some embodiments, 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 is bent, extended to the distal end, and then bent again to form at least one of the guide rods. In the present invention, the support ring and the guide rod can adopt an integrally formed structure, the ring belt is formed into an open ring at the proximal end, at least one end thereof is bent once to obtain a first bent portion, and then extended along the distal end, and then bent twice to obtain the first bent portion to form the guide rod.

[0070] Exemplarily, the ring band is wrapped around the proximal end to form an elliptical open ring with a major axis of 5~55mm and a minor axis of 5~25mm. The first end and the second end of the open end of the open ring structure are bent once respectively, with no limit on the bending angle, and then extended along the distal end, followed by a second bending, which can satisfy the constraints of the four degrees of freedom of the support ring in the front, back, left and right directions. The two-bending design can constrain the six degrees of freedom in six directions, making it completely constrained and fixed.

[0071] In some embodiments, the first bending portion and the second bending portion are independently bent in an arc shape, and the bending angles of the first bending portion and the second bending portion are the same or different. Specifically, the bending angle of the first bending portion is 5~175°. In the present invention, it 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 bending portion is 5~90°, and the second bending portion in the present invention refers to the angle between the extension line of the guide rod and the extension line of the second bending portion. The present invention achieves multi-directional freedom constraint by adjusting the bending angles of the first bending portion and the second bending portion, thereby avoiding the problem of rotation of the proximal end of the net bag. The material of the guide rod is memory metal, biocompatible plastic metal or elastic metal. The material of the guide rod and the support ring can be the same or different, preferably the same material. Further, when the number of the guide rods is at least two, the two adjacent guide rods are parallel to each other or intersecting in parallel.

[0072] In some embodiments, the skirt includes a main body and a connecting portion, the main body wraps the support ring along the circumferential direction, the connecting portion extends toward the net bag, and at least one connecting hole is circumferentially arranged on the surface of the connecting portion. The skirt is formed by sewing, knitting, weaving or braiding. The skirt material includes a polymer or animal pericardium. Specifically, the polymer includes a polyester polymer, PTFE or ePTFE, etc. Further, the polymer can be poly(hexamethylene terephthalate). Animal pericardium includes but is not limited to bovine pericardium material or porcine pericardium material. The skirt material needs to have a certain degree of compliance so that it can fit the support ring and the net bag respectively, and also avoid damaging other human tissues during the operation. The connecting holes circumferentially arranged on the skirt connecting portion are used for suturing and connecting the support ring.

[0073] In some embodiments, the connection module includes a first connection component and a second connection component. The first connection component detachably connects the net bag and the support module along the circumferential direction. The second connection component detachably connects the net bag and the support module through the connection hole of the skirt connection part, and the second connection component at least connects the surface of the net bag away from the guide rod with the connection hole. Specifically, taking the axis of the net bag opening as the dividing line, the half of the net bag close to the guide rod is recorded as the upper half, and the half away from the guide rod is recorded as the lower half, then the second connection component is used to connect at least one point on the surface of the lower half of the net bag with the connection hole, and at most fixed along the circumference of the net bag and not exceeding the corner of the lower half and the upper half. The present invention first disassembles and withdraws the first connection component, and then tightens the opening of the net bag, so that the net bag shrinks in the direction close to the guide rod, and fixes the lower half of the net bag by the second connection component, which can effectively prevent the net bag from slipping off the target tissue.

[0074] In some embodiments, the first connection component and / or the second connection component includes at least one of a threaded connection, a wedge connection, a pin connection, and a key connection. That is, the first connection component or the second connection component in the present invention can use any one of the above-mentioned connection components to achieve a detachable connection, or a combination of at least two connection components to achieve a detachable connection, and the connection method and material of the first connection component and the second connection component can be the same or different, and the present invention does not specifically limit this. In the present invention, the sewing connection between the net bag and the support module solves the problems of difficult mechanical processing and long processing cycle, ensures firmness, and improves the efficiency of net sleeve production.

[0075] In some embodiments, the first connecting component and / or the second connecting component are made of silk, elastic metal wire or polymer material, wherein the polymer material includes but is not limited to one or more of polyoxymethylene, polytetrafluoroethylene, polyethylene, polyamide resin, polycarbonate and the like.

[0076] Exemplarily, in the present invention, the first connecting component can adopt a polymer fixing line, pass through the main body of the skirt in a winding manner, and connect and fix the support module circumferentially along the open end of the net bag, which solves the problems of difficult processing and long cycle, and greatly improves the efficiency of net sleeve production. The first connecting component in the present invention is used as a temporary fixation and can be withdrawn during surgery. The second connecting component is cross-threaded on the net bag and passes through the connecting hole on the skirt connecting part to connect the net bag to the support module. After the first connecting component is withdrawn, it can prevent the net bag from falling off the support module before ligation. The second connecting component is also temporarily fixed, and can also be a polymer fixing line that can be withdrawn during surgery. At the same time, during the application process, the first connecting component is withdrawn first, the net bag opening is tightened, and then the second connecting component is withdrawn. The present invention realizes step-by-step release through the first connecting component and the second connecting component, improves system stability, and shortens implantation time.

[0077] In some embodiments, a ligation and tightening rope is provided on the net bag; the net bag is a three-dimensional braided body with a hollow mesh, and the ligation and tightening rope is cross-threaded between the hollow meshes along the circumference of the net bag opening. One end of the ligation and tightening rope is fixedly constrained on the net bag, and the other end is pulled to make the ligation and tightening rope slide toward the distal end to achieve a tightening effect. Specifically, the shape of the hollow mesh is rectangular, prism-shaped or honeycomb-shaped. Compared with the traditional fixing method, the tightening rope knot of the present invention does not need to be woven and fixed with the net bag as a whole, and only needs to cross the hollow mesh of the net bag circumferentially at the opening end of the net bag, thereby reducing the tissue gap and reducing the difficulty of weaving the net bag. At least one waist tightening rope is provided along the circumference of the middle part of the net bag. The ligation and tightening rope and the waist tightening rope are both unidirectionally slidably arranged. The net bag is tightened and fixed outside the left atrial appendage, and the left atrial appendage can be more fully and firmly covered by tightening twice. The setting method of the waist tightening rope is the same as the setting method of the ligation and tightening rope. When the net bag is used to ligate the left atrial appendage, the ligation tightening rope is first tightened until the ligation tightening rope is tightened to 90%-95%, and then the waist tightening rope is tightened to discharge the blood inside the left atrial appendage to prevent secondary thrombosis, which is beneficial to the rapid atrophy of the left atrial appendage. Finally, the ligation tightening rope is tightened to 100%, and the left atrial appendage is completely closed. The ligation tightening rope and the waist tightening rope are both unidirectionally slidably arranged, and are fixed by knotting or buckling commonly used in the art, and are tightened after unidirectional sliding. One end of the ligation tightening rope or the waist tightening rope is fixedly constrained, and the other end is pulled toward the far end, so that the ligation tightening rope or the waist tightening rope slides to achieve the tightening function.

[0078] In another specific embodiment, the present invention provides a ligation device system, the ligation device system includes a conveying device, and a mesh device for tissue ligation described in a specific embodiment, the conveying device is connected to a support module of the mesh device. The conveying device is used to convey the mesh device to the left atrial appendage, and to release and withdraw the mesh device after ligation. The conveying device can repeatedly capture the left atrial appendage. When the first capture position is not good, the conveying device is used to retract the mesh device, and a suitable position is selected to release it again to achieve repeated positioning and capture.

[0079] In some embodiments, the delivery device includes a push catheter, and the push catheter is further provided with a plurality of mutually independent lumens, and the plurality of lumens are used to flexibly connect the support ring, the connection module and the net bag. The push catheter of the present invention is also provided with necessary push handles, guide wires, connecting wires and other components, and the present invention does not make special requirements for this, and technicians in this field need to reasonably adjust, add or delete according to actual production needs.

[0080] Exemplarily, the specific method of using the ligation device system provided by the present invention includes:

[0081] A lumen in the push catheter is used to introduce the mesh device through the intercostal minimally invasive incision. Under the guidance of DSA (digital subtraction angiography), the pericardium is punctured. After the mesh device is delivered to the vicinity of the left atrial appendage, the push handle slides the support ring to the root of the left atrial appendage; first withdraw the first connection component to initially separate the mesh bag from the support ring, then tighten the ligation tightening rope to 90-95%, and then tighten the waist tightening rope to squeeze the left atrial appendage to discharge the blood inside to prevent thrombus formation; then tighten the ligation tightening rope to 100% to completely close the left atrial appendage. Secondly, withdraw the second connection component to completely separate the mesh bag from the support ring. At this time, the delivery device can be withdrawn as a whole and the excess line can be cut off. Finally, left atrial angiography is performed to confirm that the left atrial appendage is successfully ligated.

[0082] Example 1-1

[0083] This embodiment provides a mesh device 100 for tissue ligation, comprising a support module, a mesh bag 4 and a connection module. Figure 1 , Figure 2 and Figure 3 As shown, the support module includes an integrally formed support ring 1 and two guide rods 2, and a skirt 3 arranged along the circumference of 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, and is made of nickel-titanium metal. The two guide rods 2 are arranged parallel to each other, and the proximal end and the distal end of the guide rod 2 are respectively provided with a first bending portion 201 and a second bending portion 202, and the first bending portion 201 and the second bending portion 202 are bent in an arc toward the same side of the guide rod 2. The first bending portion 201 is connected to the support ring 1, and the bending angle is 90°, and the bending angle of the second bending portion 202 is 90°.

[0084] The skirt 3 is woven with hexanediol phthalate fabric and includes a main body 301 and a connecting part 302. The main body 301 is wrapped on the support ring 1, and the connecting part 302 extends toward the net bag 4 and is sewn and connected to the net bag 4 through the connecting module. Figure 5 As shown, the surface of the connection portion 302 of the skirt 3 is provided with connection holes 303 evenly distributed along the circumferential direction. Figure 4 As shown, the second connecting component 52 crosses through the hollow grid of the net bag along the circumference of the opening end of the net bag, and passes through the connecting hole 303 to connect the skirt 3 with the support ring 1, so that the net bag 4 is tightly connected to the support ring 1.

[0085] like Figure 1 and Figure 6As shown, the net bag 4 is a three-dimensional braided body with a diamond-shaped hollow mesh, which is woven with oblique needles. A ligature tightening rope 401 and a waist tightening rope 402 are arranged circumferentially on the net bag 4. The ligature tightening rope 401 is arranged circumferentially along the opening end of the net bag 4 and crosses between the hollow meshes. The waist tightening rope 402 is located in the middle of the net bag 4 and crosses between the hollow meshes. The ligature tightening rope 401 and the waist tightening rope 402 are both unidirectionally slidably arranged and fixed with buckles.

[0086] like Figure 1 and Figure 4 As shown, the connection module includes a first connection component 51 and a second connection component 52. The first connection component 51 connects the main body 301 of the skirt 3 and the net bag 4 in a circumferential manner along the circumference of the open end of the net bag 4, and is disassembled by pulling one end set in the tube cavity, and the other end can be set in the same tube cavity or not set. The second connection component 52 connects the main body 301 of the skirt and the net bag 4 in a circumferential manner along the circumference of the open end of the lower half of the net bag, and passes through the connection hole 303 on the skirt connection part 302 at the same time, and is disassembled by pulling one end set in the tube cavity, and the other end can be set in the same tube cavity or not set. The first connection component 51 and the second connection component 52 are both made of polyformaldehyde material with a low friction coefficient.

[0087] Example 1-2

[0088] This embodiment provides a mesh device 100 for tissue ligation, which is different from the embodiment 1-1 in that: Figure 7 and Figure 8 As shown, the support ring 1 is a double ring structure, connected by a slide rail 101, and the rest of the structure is the same as that of embodiment 1-1. Fig. 9 and Fig.10 As shown, the support ring 1 is tightened following the ring contraction, preventing the net bag 4 from slipping off the target tissue during the ligation process, thereby enhancing the overall stability.

[0089] Examples 1-3

[0090] This embodiment provides a mesh device 100 for tissue ligation, which is different from the embodiment 1-1 in that: Fig.11 As shown, the net bag 4 is a three-dimensional woven body with a rectangular hollow grid, woven with straight needles, and the rest of the structure is the same as that of Example 1-1.

[0091] Examples 1-4

[0092] This embodiment provides a mesh device 100 for tissue ligation, which differs from Embodiment 1-1 in that the connection module only includes a first connection component 51, and a second connection component 52 is not provided, and the rest of the structure is the same as that of Embodiment 1-1.

[0093] Example 2-1

[0094] This embodiment provides a ligation device system, such as Fig.12 As shown, it includes a conveying device and a mesh device 100 for tissue ligation provided in Example 1-1, and the conveying device is used to convey the mesh device 100 to the left atrial appendage and realize the release and withdrawal of the mesh device 100 after ligation. The structure of the mesh device 100 is exactly the same as that of Example 1-1, and will not be described here. The conveying device includes a push catheter, and at least four independent lumens are arranged inside the push catheter. One of the lumens is used to accommodate the mesh device 100, one lumen is used to pre-embed one end of the first connecting component 51; one is used to pre-embed one end of the second connecting component 52, one lumen is pre-embedded with a buckle of the ligation tightening rope 401; and one lumen is pre-embedded with a buckle of the waist tightening rope 402. After releasing the mesh device 100, the support ring 1 and the net bag 4 both extend out of the lumen, and at least the second bending portion 202 is retained in the lumen to ensure that the mesh device 100 can be withdrawn smoothly. In this embodiment, after the first connecting component 51 is withdrawn, the second connecting component 52 is still used to temporarily fix the support ring 1 and the net bag 4 to prevent the net bag 4 from falling off before ligation, thereby achieving step-by-step release, improving the success rate of tissue ligation, and increasing the stability of the system.

[0095] Example 2-2

[0096] This embodiment provides a ligation device system, which differs from Embodiment 2-1 in that the mesh device 100 used is the mesh device 100 for tissue ligation provided in Embodiment 1-4, and the rest of the structure is the same as that of Embodiment 2-1.

[0097] Application Example 1

[0098] This application example uses the ligation device system of Example 2-1 to ligate the chicken wing type left atrial appendage, which specifically includes the following steps: Fig.13 and Fig.14 As shown:

[0099] Use pericardiocentesis needle to puncture epicardium, send 0.18mm guide wire into pericardial layer, expand the passage with expansion sheath, separate pericardial adhesion, inject contrast agent to determine the position of left atrial appendage. Push catheter sheath to the front end of left atrial appendage, then push net device 100 through a lumen in push catheter to puncture pericardium, reach the front end of left atrial appendage under DSA guidance, net bag 4 captures left atrial appendage. Push handle slides support ring 1 to the root of left atrial appendage and starts to tighten net bag 4. First withdraw the first connecting component 51, make net bag 4 and support ring 1 initially separated, then tighten ligation tightening rope 401, tighten to 90~95%, tighten waist tightening rope 402, to discharge blood inside left atrial appendage, prevent secondary thrombosis, then tighten ligation tightening rope 401 to 100%, completely close left atrial appendage. Then withdraw the second connecting assembly 52 to completely separate the net bag 4 from the support ring 1, and then the delivery device can be withdrawn as a whole and the excess wire can be cut off. Finally, perform left atrial angiography to verify the success of left atrial appendage ligation.

[0100] This application example uses the support ring 1 to prop up the space around the target tissue so that the net bag 4 can accurately cover the target tissue. The support ring 1 has a ring contraction function and provides a large radial support force to prevent the net bag 4 from slipping off the tissue during the ligation process, thereby enhancing the overall stability. At the same time, the guide rod 2 adopts a double bending design to prevent the net bag from rotating, which is convenient for capturing tissue. In addition, after the target tissue is covered, the first connecting component 51 is withdrawn, and the support ring 1 and the net bag 4 can still be temporarily fixed through the second connecting component 52 to prevent the net bag 4 from falling off before ligation, thereby achieving step-by-step release and improving the success rate of tissue ligation.

[0101] Application Example 2

[0102] This application example uses the ligation device system of Example 2-2 to ligate the chicken wing-shaped left atrial appendage, which specifically includes the following steps:

[0103] Use pericardiocentesis needle to puncture epicardium, send 0.18mm guide wire into pericardial layer, expand the passage with expansion sheath, separate pericardial adhesion, inject contrast agent to determine the position of left atrial appendage. Push catheter sheath to the front end of left atrial appendage, then push net device 100 to the front end of left atrial appendage under DSA guidance through a lumen in the push catheter, and net bag 4 captures left atrial appendage. Push handle slides support ring 1 to the root of left atrial appendage and starts to tighten net bag 4. Withdraw the first connecting assembly 51, separate net bag 4 from support ring 1, and then tighten ligation tightening rope 401 to 100%, completely closing left atrial appendage. Then withdraw the conveying device as a whole and cut off the excess line. Finally, perform left atrial angiography to verify the successful ligation of left atrial appendage.

[0104] In this application example, after capturing the left atrial appendage, the first connecting component 51 is withdrawn, so that the net bag 4 loses its temporary fixing point and is prone to slipping, which is not conducive to the success rate of tissue ligation.

[0105] Comparative Example 1-1

[0106] This comparative example provides a mesh bag 300 for tissue ligation, which differs from Example 1-1 in the structure of the support module. The support module of this comparative example is not provided with a support ring and a skirt, and the two ends of the guide rod are not provided with a first bending portion and a second bending portion. The net bag is directly fixed to the guide rod through a ligation tightening rope, and the rest of the structure is the same as Example 1-1.

[0107] Comparative Example 2-1

[0108] This comparative example provides a ligation device system, such as Fig.15 As shown, it includes a conveying device and a mesh sleeve 300 for tissue ligation provided in comparative example 1-1, and the conveying device is used to convey the mesh sleeve 300 to the left atrial appendage and realize the release and withdrawal of 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 here. The conveying device includes a push catheter, and at least four independent lumens are arranged inside the push catheter. One of the lumens is used to accommodate the mesh sleeve 300, and a buckle of a ligation tightening rope is pre-embedded in one lumen; a buckle of a waist tightening rope is pre-embedded in one lumen.

[0109] Comparative application example 1

[0110] This comparative application example uses the ligation device system of comparative example 2-1 to ligate the chicken wing-shaped left atrial appendage, which specifically includes the following steps:

[0111] Use pericardiocentesis needle to puncture epicardium, send 0.18mm guide wire into pericardial layer, expand the passage with expansion sheath, separate pericardial adhesion, inject contrast agent to determine the position of left atrial appendage. Then push catheter sheath to the front end of left atrial appendage, and then push net 300 through a lumen pericardial approach in the push catheter, DSA reaches the front end of left atrial appendage, and net bag 4 captures left atrial appendage. Use push handle to tighten ligation tightening rope to 100%, completely close left atrial appendage. Withdraw the delivery device, cut off the excess line, and finally perform left atrial angiography to verify the successful ligation of left atrial appendage.

[0112] In this comparative application example, after the net bag reaches the front end of the left atrial appendage, it is difficult to capture the left atrial appendage because the space around the left atrial appendage is not fully supported, and the supporting force of the open end of the net bag is relatively low, which makes it easy to slip, resulting in unsuccessful ligation.

[0113] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. A mesh device for tissue ligation, characterized in that: The net device for tissue ligation comprises a support module, a net bag and a connection module, wherein the support module comprises a support ring, a skirt and at least one guide rod, wherein the skirt covers the support ring, and the skirt comprises a main body and a connection part, wherein the main body wraps the support ring along the circumferential direction, the connection part extends toward the net bag, and the surface of the connection part is provided with at least one connection hole along the circumferential direction; The support ring is retractable in the circumferential direction to expand the space around the target tissue. The proximal end and the distal end of the guide rod are respectively provided with a first bending portion and a second bending portion, the first bending portion and the second bending portion are bent toward the same side of the guide rod, and the first bending portion is connected to the support ring to prevent the proximal end of the net bag from rotating during the process of capturing the target tissue. At least one end of the net bag is provided with an opening, and the opening of the net bag is detachably connected to the support ring along the circumferential direction through the connection module, and the connection module includes a first connection component and a second connection component; the first connection component is detachably connected to the net bag and the support module along the circumferential direction; The second connecting component detachably connects the net bag and the supporting module through the connecting hole of the skirt connecting portion, and the second connecting component at least connects a portion of the surface of the net bag away from the guide rod and the connecting hole; The net bag is provided with a ligation and tightening rope, and the net bag is a three-dimensional woven body with a hollow grid. The ligation and tightening rope is cross-arranged between the hollow grids along the circumference of the net bag opening, and at least one waist tightening rope is arranged along the circumference of the middle part of the net bag. The ligation and tightening rope and the waist tightening rope are both unidirectionally slidably arranged. When in use, the first connecting component is withdrawn first, the net bag opening is tightened, and then the second connecting component is withdrawn to release the net bag in steps.

2. The mesh device for tissue ligation according to claim 1, characterized in that: The support ring is a single-ring structure or a multi-ring structure; The support ring is made of elastic metal; The support ring is an open ring structure or a closed ring structure.

3. The mesh device for tissue ligation according to claim 2, characterized in that: The support ring is an open ring structure, and the support ring has a first end and a second end; The first end portion and / or the second end portion is bent, extended toward the distal end, and then bent again to form at least one guide rod.

4. The mesh device for tissue ligation according to claim 1, characterized in that: The first bending portion and the second bending portion are independently bent in arcs; The bending angles of the first bending portion and the second bending portion are the same or different; The bending angle of the first bending portion is 5-175°; The bending angle of the second bending portion is 5 to 90°; The guide rod is made of elastic metal; When the number of the guide rods is at least two, two adjacent guide rods are parallel to each other or intersecting in parallel.

5. The mesh device for tissue ligation according to claim 1, characterized in that: The skirt is formed by weaving; The skirt material includes high molecular polymer or animal pericardium.

6. The mesh device for tissue ligation according to claim 1, characterized in that: The first connection assembly and / or the second connection assembly comprises at least one of a threaded connection, a wedge connection and a pin connection; The first connecting component and / or the second connecting component are made of elastic metal wire or polymer material.

7. The mesh device for tissue ligation according to claim 1, characterized in that: The shape of the hollow grid is rectangular or honeycomb.

8. A ligation device system, characterized in that: The ligation device system includes a conveying device and a mesh device for tissue ligation as described in any one of claims 1 to 7, wherein the conveying device is connected to the support module of the mesh device, and the conveying device includes a push catheter, wherein the push catheter is further provided with a plurality of independent lumens, and the plurality of lumens are used to flexibly connect the support ring, the connection module and the mesh bag respectively.

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