A pre-tightening positioning device and a tissue ligation system device

Abstract

The present invention provides a pre-tightening positioning device and a tissue ligation system device, wherein the pre-tightening positioning device comprises a support assembly and a tightening line, wherein the support assembly has a distal end and a proximal end, and a plurality of elastic inner connecting members are arranged along the circumference of the support assembly, wherein the tightening line passes through the plurality of elastic inner connecting members in sequence, and the end of the tightening line extends from the distal end of the support assembly, and an elastic outer connecting member is arranged on the outer surface of the support assembly, wherein the elastic outer connecting member wraps the support assembly, the elastic inner connecting member and the tightening line. The present invention accurately captures the target tissue, realizes the integration of positioning capture and tissue ligation, and improves the success rate of ligation.

Description

Technical Field

[0001] The invention belongs to the technical field of tissue ligation, and relates to a pre-ligation positioning device and a tissue ligation system device. Background Art

[0002] At present, tissue closure usually adopts clamping devices and ligation devices, both of which require independent instruments to locate and capture the diseased tissue, such as grabbers, balloons, suction cups and other auxiliary instruments. Due to the small operating space in the body, the existing auxiliary instruments are complicated to operate, and they are easy to damage other tissues of the human body during use, causing bleeding, which is not conducive to treatment.

[0003] In order to improve the success rate of ligation and reduce the risk of surgery, CN115553851A provides a surgical vascular ligation device, wherein the support mechanism is respectively arranged at the front and rear of the lower end of the ring wall of the No. 1 finger ring; the No. 1 connecting rod is respectively formed with the right end of the No. 1 connecting rod and the No. 2 connecting rod; the limiting mechanism is respectively arranged at the right end of the No. 1 connecting rod; the auxiliary mechanism is arranged on the upper limiting mechanism; the ligation device is prevented from being unstable when clamping the blood vessel, resulting in the blood vessel being pulled; the two ends of the blood vessel to be ligated can be clamped to reduce bleeding during suture ligation. CN115252033A discloses an airbag suction type left atrial appendage stabilization and ligation system, which includes: an annular airbag, a trumpet airbag, a ligation ring traction line, a ligation ring unhooking soft guide wire, a ligation ring, a trumpet airbag inflation hole, a central suction hole, an annular airbag inflation hole and a support frame, and the trumpet balloon structure is combined with negative pressure suction to make the left atrial appendage easier to capture and fix. CN217793485U discloses a laparoscopic suction device, including a housing, which is rotatably connected to a rotating column. First, a three-claw clamp is connected to a suction cup and enters the abdominal cavity. The three-claw clamp can fix the suction cup well. After the external negative pressure suction device is turned on, the suction cup can effectively adsorb and fix the outer wall of the cyst. The puncture structure is turned on, and the puncture structure can blast the cyst. After the blast, the exudate inside can be sucked in time by the device. After the suction is completed, the ligature band can ligate the puncture site well to prevent the residual liquid from leaking out.

[0004] However, current auxiliary instruments cannot be repositioned. If the release position is wrong, other instruments need to be replaced to remove it and then reassembled for release, which increases the risk of surgery. In addition, adding an additional auxiliary instrument not only increases the complexity of the operator's operation, but also has multiple entry and exit points, which can easily cause intraoperative problems, reduce perioperative treatment effects, and increase surgical costs.

[0005] Therefore, considering the surgical process and long-term benefits, it is urgent to develop a device that integrates positioning, capture and tissue ligation to make the surgery more convenient and reduce the risks during the operation. Summary of the invention

[0006] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a pre-tightening positioning device and a tissue ligation system device, which can repeatedly position without the need for in vivo vision to accurately capture the target tissue, thereby realizing the integration of positioning capture and tissue ligation and improving the success rate of tissue ligation.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] In the first aspect, the present invention provides a pre-tightening positioning device, which includes a support assembly and a tightening line, wherein the support assembly has a distal end and a proximal end, and a plurality of elastic inner connecting parts are arranged along the circumference of the support assembly, the tightening line passes through the plurality of elastic inner connecting parts in sequence, and the end of the tightening line extends out from the distal end of the support assembly, and an elastic outer connecting part is arranged on the outer surface of the support assembly, and the elastic outer connecting part wraps the support assembly, the elastic inner connecting part and the tightening line.

[0009] The present invention utilizes a support component to capture the target tissue and supports the tightening line to avoid the problem of falling off; the tightening line slides from the distal end, thereby driving the elastic inner connecting part to stretch circumferentially, so that the elastic inner connecting part is close to the target tissue and pre-tightened, thereby achieving the positioning of the target tissue to confirm that the capture is successful, and then relying on the elastic retraction of the elastic inner connecting part itself, the target tissue can be released, and the elastic outer connecting part is subjected to force transmission to produce the same deformation, thereby playing the role of positioning, capturing and protecting the target tissue, thereby achieving repeated tightening and release.

[0010] When the elastic inner connecting piece is used to tighten and release the target tissue, the tensile force of the tightening line is different. During use, the tightening state and the release state of the target tissue can be indicated by feeding back the force value to the operator, and the successful extraction of the target tissue can be ensured without the need for in vivo visual field.

[0011] It should be noted that the distal end in the present invention refers to the end close to the operator, and the proximal end refers to the end close to the target tissue.

[0012] As a preferred technical solution of the present invention, the support assembly includes a sleeve ring body, and a plurality of positioning grooves are opened along the inner ring surface of the sleeve ring body, and the elastic inner connecting member is at least partially located in the positioning grooves.

[0013] The sleeve ring body is connected to the elastic inner connecting piece by screws, snaps, welding, bonding or integral injection molding.

[0014] In the present invention, the elastic inner connector is embedded in the sleeve ring body to play a role of fitting and complementing; the sleeve ring body provides radial support force for capturing the target tissue, ensuring that the tightening line drives the elastic inner connector to stretch and tighten circumferentially, avoiding slipping from the target tissue, which is beneficial to improving the success rate of subsequent tissue ligation.

[0015] It should be noted that the shape of the sleeve ring in the present invention includes all shapes formed by surrounding, and is not limited to a circle, but can also be a rectangle, an ellipse or an irregular polygon, etc. The present invention does not make any specific limitation on this.

[0016] As a preferred technical solution of the present invention, a bent connection portion is also provided at the distal end of the support assembly.

[0017] The bent connection portion includes two connecting rods, one ends of the two connecting rods intersect and are respectively connected to the sleeve ring body, and the other ends of the two connecting rods extend in parallel to the distal end.

[0018] The material of the sleeve ring body is elastic metal.

[0019] In the present invention, the sheath ring body is fixed to the pushing device through a bent connection portion, which increases the stability of the device. The sheath ring body has a memory function and can be stored in the pushing device and transferred to the target tissue, and then released from the pushing device and unfolded in the body.

[0020] The sleeve ring body is an elliptical ring body or a perfect circular ring body.

[0021] The length of the major axis of the sleeve ring body is 1~55mm, for example, it can be 1mm, 2mm, 5mm, 10mm, 12mm, 15mm, 20mm, 25mm, 28mm, 30mm, 35mm, 40mm, 45mm, 48mm, 50mm or 55mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0022] The length of the short axis of the sleeve ring body is 1~25mm, for example, it can be 1mm, 2mm, 5mm, 10mm, 12mm, 14mm, 15mm, 18mm, 20mm, 22mm or 25mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0023] It should be noted that the lengths of the major axis and the minor axis may be the same or different. When the lengths of the major axis and the minor axis are the same, the sleeve ring body is a perfect circle, and when the lengths of the major axis and the minor axis are different, the sleeve ring body is an ellipse.

[0024] As a preferred technical solution of the present invention, an active cavity is opened inside the elastic inner connecting member, and the tightening wire passes through the active cavity and slides relatively along the inside of the active cavity.

[0025] The elastic inner connecting piece is an elastic sleeve, an elastic braided body or an elastic film.

[0026] The elastic inner connecting piece is a closed structure or an open structure.

[0027] The elastic inner connecting piece is made of biocompatible elastic material.

[0028] The elastic inner connector described in the present invention can produce elastic deformation under external force, and when the external force disappears, it can quickly return to its original state without repair or replacement, so as to repeat positioning and tightening. At the same time, when impacted by external forces such as sliding of the tightening line or squeezing of biological tissue, the elastic inner connector has a shock-absorbing and buffering effect to avoid damage to the target tissue.

[0029] It should be noted that the shape of the elastic inner connecting member is not specifically limited in the present invention, and may be cylindrical, annular, polyhedral, or an open structure or a spliced ​​structure formed to adapt to different connection methods.

[0030] The length of the elastic inner connecting member is 0.1~12mm, for example, it can be 0.1mm, 0.5mm, 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm, 6.0mm, 7.0mm, 8.0mm, 9.0mm, 10.0mm, 11.0mm or 12.0mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0031] The width of the elastic inner connecting member is 0.1~12mm, for example, it can be 0.1mm, 0.5mm, 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm, 6.0mm, 7.0mm, 8.0mm, 9.0mm, 10.0mm, 11.0mm or 12.0mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0032] The wall thickness of the elastic inner connecting member is 0.1~10mm, for example, it can be 0.1mm, 0.5mm, 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm, 6.0mm, 7.0mm, 8.0mm, 9.0mm or 10.0mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0033] As a preferred technical solution of the present invention, the elastic outer connecting member is independently connected to the supporting assembly, the elastic inner connecting member and the tightening wire by screws, snap-fit ​​connections, welding, bonding or integral injection molding.

[0034] The elastic outer connecting piece is made of biocompatible elastic material.

[0035] The elastic external connecting piece is an elastic sleeve, an elastic braided body or an elastic film.

[0036] The elastic outer connecting member and the elastic inner connecting member may be made of the same or different materials.

[0037] In the present invention, the elastic outer connecting piece wraps the sleeve ring body, the elastic inner connecting piece and the tightening wire of the support component inside to achieve press-fit fixation. During use, the elastic inner connecting piece undergoes the same deformation as the elastic deformation, thereby playing a role in positioning and capturing, while also preventing the tightening wire from cutting tissues.

[0038] As a preferred technical solution of the present invention, the tightening wire is made of polyester material, fluoropolymer or animal pericardium material.

[0039] The outer surface of the tightening wire is covered with a reinforcement layer.

[0040] The reinforcement layer is made of polymer material or metal material.

[0041] The tightening wire of the present invention has certain compliance, so that it fits with the elastic inner connecting piece to prevent damage to other tissues of the human body during use.

[0042] In a second aspect, the present invention provides a tissue ligation system device, which includes a push sheath, a knot pushing assembly, a ligation line, a net bag and the pre-tightening positioning device described in the first aspect, wherein the push sheath is movably connected to the distal end of the support assembly, the tightening line, the knot pushing assembly and the ligation line, and the net bag is connected to the proximal end of the support assembly.

[0043] The tissue ligation system device of the present invention realizes the integration of tissue tightening positioning and tissue ligation, and has a knot pushing function. It can perform secondary positioning after the target tissue is pre-tightened and positioned, ensure the successful collection of biological tissue through double positioning, and push the ligation line to the root position of the target tissue to improve the ligation success rate.

[0044] As a preferred technical solution of the present invention, the pushing sheath includes a plurality of lumens.

[0045] As a preferred technical solution of the present invention, the pushing knot assembly includes a movable inner tube and an outer sleeve that are nested, one end of the movable inner tube extends out of the outer sleeve and is provided with a proximal guide portion, and the end of the outer sleeve away from the proximal guide portion is movably connected to the pushing sheath tube.

[0046] The outer wall of the movable inner tube is provided with a first blade, and the first blade is located at a side close to the proximal guide portion.

[0047] A second blade is disposed at one end of the outer sleeve close to the proximal guide portion, and the second blade is disposed opposite to the first blade.

[0048] A wire guide groove is provided on the surface of the movable inner tube, and the wire guide groove is located between the first blade and the second blade.

[0049] One end of the ligature is arranged along the circumference of the net bag, and the other end of the ligature is passed through the lead groove and then introduced into the push sheath tube for ligating the target tissue.

[0050] The ligature line is provided with a ligature knot, and the ligature knot is provided close to the end of the proximal guide portion, and the maximum diameter of the proximal guide portion is smaller than the caliber of the ligature knot.

[0051] The ligature and the net bag are respectively made of bioabsorbable materials.

[0052] The push-knot design of the present invention has a wire-cutting function, which reduces the entry of instruments, thereby reducing bleeding points and reducing the risk of bleeding. In the present invention, part of the ligature at the front end of the ligature knot is arranged along the circumference of the net bag, and part of the ligature at the rear end of the ligature knot is introduced into any lumen of the push sheath. During use, the ligature of the target tissue can be ligated by pulling the part of the ligature, and the extension line at the rear end of the ligature knot can be cut by the cooperation of the first blade and the second blade. At the same time, the size of the proximal guide part is smaller than the caliber size of the ligature knot, so that the push-knot assembly can be withdrawn smoothly.

[0053] As a preferred technical solution of the present invention, the push-knot assembly is located at the upper end or the lower end of the intersection of the bent connection parts of the support assembly.

[0054] It should be noted that the intersection point in the present invention refers to the intersection point of two connecting rods of the bent connecting part.

[0055] A passivation layer is provided on the surface of the proximal guide portion.

[0056] The maximum diameter of the proximal guide portion is 0.1-2 mm, for example, 0.1 mm, 0.2 mm, 0.5 mm, 1.0 mm, 1.2 mm, 1.5 mm, 1.8 mm or 2.0 mm, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0057] Compared with the prior art, the present invention has the following beneficial effects:

[0058] (1) The pre-tightening positioning device provided by the present invention can locate and capture the target tissue before tissue ligation through the design of the elastic inner connecting part and the elastic outer connecting part, confirm the successful capture of the target tissue, and greatly improve the success rate of tissue ligation; at the same time, the tightening line and the target tissue are isolated, which can protect the tissue and prevent it from being cut during tightening; in addition, the elastic inner and outer connecting parts can be tightened and released repeatedly, and multiple attempts can be made, which improves the positioning and capture fault tolerance rate.

[0059] (2) The present invention provides a tissue ligation system device with a push-knot design, which can perform secondary positioning after pre-tightening and positioning the captured tissue to ensure successful capture of the target tissue, and then ligate the target tissue at its root, thus realizing the integration of positioning capture and tissue ligation. The push-knot design has a thread cutting function, which can reduce the number of instruments entering the body, reduce bleeding points, reduce the risk of bleeding, and improve the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 This is a schematic structural diagram of the pre-tightening and positioning device provided in Example 1 of the present invention.

[0061] Figure 2 This is a schematic diagram of the tightened state of the pre-tightening and positioning device provided in Example 1 of the present invention.

[0062] Figure 3 A schematic structural diagram of the support assembly provided in Example 1 of the present invention.

[0063] Figure 4 This is a schematic structural diagram of the elastic external connecting member provided in Example 1 of the present invention.

[0064] Figure 5 This is a schematic diagram of the elastic external connecting member in a tightened state provided in Example 1 of the present invention.

[0065] Figure 6 This is a schematic structural diagram of a tissue ligation system device provided in Example 2 of the present invention.

[0066] Among them, 1-sleeve ring body; 2-elastic inner connecting piece; 3-tightening line; 4-elastic outer connecting piece; 5-pushing sheath; 6-proximal guide part; 7-movable inner tube; 8-outer sheath; 9-first blade; 10-second blade; 11-connecting rod; a-intersection point. DETAILED DESCRIPTION

[0067] 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.

[0068] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0069] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0070] In a specific embodiment, the present invention provides a pre-tightening positioning device, including a support component and a tightening line, wherein the support component has a distal end and a proximal end, and a plurality of elastic inner connectors are arranged along the circumference of the support component, wherein the tightening line passes through the plurality of elastic inner connectors in sequence, and the end of the tightening line extends from the distal end of the support component, and an elastic outer connector is arranged on the outer surface of the support component, wherein the elastic outer connector wraps the support component, the elastic inner connector and the tightening line, thereby protecting the target tissue. During use, the support component is used to cover the target tissue, and the tightening line is slid from the distal end, thereby driving the elastic inner connector to stretch circumferentially, so that the elastic inner connector approaches the target tissue and is pre-tightened, and the elastic outer connector is subjected to force transmission to produce the same deformation, thereby covering the target tissue. Moreover, the elastic inner connector and the elastic outer connector can release the target tissue by their own elastic retraction, and can be positioned repeatedly.

[0071] In some embodiments, the support assembly includes a sheath ring body, which is located at the proximal end of the support assembly and is used to sheath the target tissue. The sheath ring body is made of elastic metal. In order to smoothly store the sheath ring body in the push device and unfold it after being released in the body by the push device, a material with memory function is preferably used, including but not limited to nickel titanium, titanium alloy, etc. Further, the sheath ring body can also be made of plastically deformable materials, including but not limited to biocompatible cobalt-chromium metal frames well known to those skilled in the art, laser-cut stainless steel rigid metal tubes, or braided flexible spring tubes. When a flexible spring tube design is used, a reinforcing wire with a memory function having a certain supporting force needs to be added to the inner cavity of the tube to provide supporting force.

[0072] Specifically, the extraction ring body is an elliptical ring body or a perfect circular ring body. Preferably, the length of the major axis of the extraction ring body is 1 to 55 mm, and the length of the minor axis of the extraction ring body is 1 to 25 mm. Those skilled in the art can adjust the length of the major axis and / or minor axis of the extraction ring body according to the size adaptability of the target tissue to prevent the problem of being unable to extract the target tissue or the device slipping due to size mismatch.

[0073] In some embodiments, the distal end of the support assembly is further provided with a bending connection portion for connecting the pushing device. The bending connection portion includes two connecting rods, one end of the two connecting rods intersects and is respectively connected to the sleeve ring body, and the other ends of the two connecting rods extend in parallel to the distal end, and the part of the connecting rod extending in parallel to the distal end is bent again at a certain angle. In the present invention, the connecting rod forms a certain bending angle with the plane where the sleeve ring body is located, and the two connecting rods are intersected and shaped, and the part of the connecting rod extending in parallel to the distal end can be bent again at a certain angle, which not only facilitates the fixation of the support assembly, but also avoids deflection during the tissue capture process.

[0074] Specifically, when making the support component, a mold can be provided to wrap the elastic metal wire or elastic metal rod around to form an annular sleeve ring body, and then the two free ends are bent toward the distal end respectively and intersected to shape, and then bent again so that the two free ends extend toward the distal end in parallel to complete the production.

[0075] In some embodiments, a plurality of positioning grooves are provided along the inner ring surface of the sleeve ring body, and the elastic inner connector is at least partially located in the positioning groove. The present invention does not specifically limit the shape of the positioning groove, and it can be a rectangular groove or a U-shaped groove. A plurality of positioning grooves are arranged at intervals, and the spring inner connectors are embedded in the positioning grooves one by one to fit and complement the sleeve ring body. Specifically, the sleeve ring body is screwed, snap-fitted, welded, bonded, or integrally injection molded with the elastic inner connector.

[0076] In some embodiments, an active cavity is provided inside the elastic inner connector, and the tightening wire passes through the active cavity and slides relatively along the inside of the active cavity. In the present invention, several elastic inner connectors are independent of each other and are arranged in sequence along the inner ring surface of the sleeve ring body to form a sliding path of the tightening wire composed of multiple active cavities. The tightening wire is pulled by the distal end to drive multiple elastic inner connectors to stretch circumferentially, and approach the tissue target for positioning and capture, and feedback the first force value to the operator to ensure that the sleeve ring body successfully captures the target tissue; the tightening wire is loosened by the distal end, and multiple elastic inner connectors rely on their own elastic reset to loosen the target tissue, and feedback the second force value to the operator to prompt the release of the target tissue, and the tissue can be repeatedly tightened or released. Among them, the present invention does not specifically limit the form of the feedback force value, and a conventional tightening wire tension detection device can be used. When the elastic inner connector is tightened or reset circumferentially, the tension of the tightening wire is different, thereby reflecting the state of the target tissue, and there is no need to set up an additional in vivo field of view to observe the target tissue. Furthermore, the method of feedback force value is also applicable to the ligature used in the tissue ligation process.

[0077] In addition, the operator can also use auxiliary observation equipment such as ultrasound and DSA (digital subtraction angiography) to observe the state of the target tissue when the tightening line is tightened and released to ensure that the support component successfully captures the target tissue.

[0078] The elastic inner connecting piece is an elastic sleeve, an elastic braid or an elastic film, and its outer surface is smooth, which is equivalent to a protective layer covering the outside of the exposed tightening wire, preventing the tightening wire from cutting the tissue when sliding on the surface of the target tissue, and playing a cushioning role to protect the biological tissue.

[0079] The elastic inner connector is made of biocompatible elastic material, for example, room temperature elastic material or superelastic material, including but not limited to silicone, rubber, elastic biological tissue, etc. And the biocompatible elastic material is doped with at least one of hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, di(2-ethylhexyl) phthalate, butyl benzyl phthalate, dibutyl phthalate, polydimethylsiloxane containing vinyl groups and lead. The elastic inner connector can produce elastic deformation under external force, and when the external force disappears, it can quickly return to the original state without repair or replacement, so as to repeat positioning and tightening. At the same time, when subjected to external force impact such as tightening line sliding or biological tissue extrusion, the elastic inner connector has a shock-absorbing and buffering effect to avoid damage to the target tissue.

[0080] The elastic inner connector is a closed structure or an open structure, or a spliced ​​structure. The main body of the elastic inner connector is a cylindrical, columnar, annular or other polyhedral shape formed around the movable cavity, and the present invention does not specifically limit the shape of the main body. In addition, the elastic inner connector can also be composed of a main body and a connecting part, the main body is for the tightening line to slide, and the connecting part is used to connect the support assembly. And the connecting part can be an opening, a buckle or a connecting hook, etc. that adapts to different connection methods.

[0081] Specifically, the length of the elastic inner connector is 0.1-12 mm, the width of the elastic inner connector is 0.1-12 mm, and the wall thickness of the elastic inner connector is 0.1-10 mm. It should be noted that, according to different shapes of the elastic inner connector, the length may refer to the height, horizontal length or horizontal thickness of the elastic inner connector; the width may refer to the outer diameter, vertical width or vertical thickness of the elastic inner connector; and the wall thickness refers to the thickness from the inner wall of the active cavity to the outer wall of the elastic inner connector.

[0082] In some embodiments, the elastic outer connector is made of a biocompatible elastic material, which can cover the sleeve ring, the elastic inner connector and the tightening line, and undergo elastic deformation synchronously with the elastic inner connector, playing a role of pressing and fixing, and can be repeatedly tightened and released. The elastic outer connector and the elastic inner connector can be made of the same or different materials. The elastic material can be a room temperature elastic material or a superelastic material, including but not limited to silicone, rubber, elastic biological tissue, etc.

[0083] The elastic outer connector is an elastic sleeve, an elastic braid or an elastic film. The elastic outer connector is independently connected to the support assembly, the elastic inner connector and the tightening wire by screw connection, snap connection, welding, bonding or integral injection molding. The elastic outer connector can cover the exposed part of the tightening wire, the outer surface of the sleeve ring body and the surface of the elastic inner connector contacting the target tissue, playing a cushioning and protective role, further avoiding damage to the target tissue during tissue ligation. During application, the tightening wire is pulled by the distal end, driving multiple elastic inner connectors to stretch circumferentially, while the elastic outer connector is synchronously deformed by force transmission, and is positioned and captured close to the tissue target to ensure successful capture of the target tissue; the tightening wire is loosened by the distal end, and the elastic inner connector and the elastic outer connector are reset by their own elasticity to loosen the target tissue, thereby achieving repeated tightening or release of the tissue. The deformation range of the elastic inner connecting member is between the inner ring surface of the sleeve ring body and the target tissue, while the deformation range of the elastic outer connecting member is between the outer surface of the sleeve ring body and the target tissue.

[0084] In some embodiments, the tightening line is made of polyester material, fluoropolymer or animal pericardial material. The polyester material includes, but is not limited to, polyethylene terephthalate, polycarbonate, butylene terephthalate or polylactic acid polyester. The fluoropolymer includes, but is not limited to polytetrafluoroethylene and expanded polytetrafluoroethylene. The animal pericardial material includes, but is not limited to bovine pericardial material or porcine pericardial material. The tightening line has a certain degree of compliance, so that it fits with the elastic inner connector, and the exposed part can fit with the elastic outer connector to avoid damaging other human tissues during use.

[0085] Furthermore, the outer surface of the tightening wire is coated with a reinforcement layer to enhance the anti-fracture ability of the tightening wire. The reinforcement layer is made of a polymer material or a metal material. The polymer material includes but is not limited to polytetrafluoroethylene, expanded polytetrafluoroethylene or silicone, etc.; the metal material includes but is not limited to nickel titanium or stainless steel, etc.

[0086] In another specific embodiment, the present invention provides a tissue ligation system device, which includes a push sheath, a push knot assembly, a ligature, a net bag and a pre-tightening positioning device according to a specific embodiment, wherein the push sheath is respectively movably connected to the distal end of the support assembly, the tightening line, the push knot assembly and the ligature, and the net bag is connected to the proximal end of the support assembly. The push sheath delivers the entire system into the body, the support assembly and the net bag are used in conjunction to capture the target tissue, and the ligature is used to ligate the target tissue.

[0087] In some embodiments, the pushing sheath includes several lumens, and the pushing knot assembly, the ligation line and the pre-tightening positioning device are independently connected to different lumens and placed inside the lumens. As the pushing lumen moves in the body, after reaching the target position, the lumens release them sequentially. After the ligation is completed, some components can be withdrawn into the lumen and withdrawn out of the body together with the pushing sheath.

[0088] In some embodiments, the knot-pushing assembly includes a nested movable inner tube and an outer sleeve, one end of the movable inner tube extends out of the outer sleeve, and is provided with a proximal guide portion, and one end of the outer sleeve away from the proximal guide portion is movably connected to the push sheath. The surface of the proximal guide portion is provided with a passivation layer, which is formed by a passivation treatment well known to those skilled in the art, and the inner diameter of the proximal guide portion is 0.1~2mm, which can prevent the ligation knot from sliding into the interior of the lumen. The proximal guide portion is located at the proximal or distal end of the intersection of the two connecting rods of the bent connecting portion of the support assembly, and is on the same horizontal plane as the intersection. After the elastic inner connector and the elastic outer connector are pre-tightened and positioned on the surface of the target tissue, the knot-pushing assembly pushes the ligation knot to move 0.1~20mm to achieve secondary positioning, ensuring that after the target tissue is successfully taken, it is ligated to the root position of the target tissue.

[0089] The outer wall of the movable inner tube is provided with a first blade, and the first blade is located at a side close to the proximal guide portion. The end of the outer sleeve close to the proximal guide portion is provided with a second blade, and the second blade is arranged opposite to the first blade, and both the first blade and the second blade have arc-shaped cutting edges to cooperate with cutting the ligature.

[0090] The surface of the movable inner tube is provided with a wire guide groove, the wire guide groove is located between the first blade and the second blade, the ligature wire passes through the wire guide groove, and after the ligature is completed, the first blade and the second blade of the knot pushing assembly cooperate to cut the wire. The inner surface of the wire guide groove is smooth, and the ligature wire is prevented from rubbing in the wire guide groove through passivation treatment.

[0091] One end of the ligature is arranged along the circumference of the net bag to capture the target tissue, and the other end of the ligature is introduced into the push sheath after passing through the guide groove, and is controlled by the remote operator to ligate the target tissue. The knot-pushing assembly is used to push the ligature knot to the target position. A ligature knot is arranged on the ligature, and the ligature knot is arranged near the end of the proximal guide part. The maximum diameter of the proximal guide part is smaller than the caliber of the ligature knot, so that the knot-pushing assembly can be withdrawn smoothly. Specifically, the part of the ligature at the front end of the ligature knot is arranged along the circumference of the net bag, and the part of the ligature at the rear end of the ligature knot is introduced into any lumen of the push sheath. During use, the ligature of the target tissue can be achieved by pulling the part of the ligature, and the extension line at the rear end of the ligature knot is cut by the cooperation of the first blade and the second blade. The ligature is made of slowly absorbed bioabsorbable material, including but not limited to glycolide polymer, ring-opening polymerization of lactide-lactide, lactide-glycolide copolymer, polyglycolate, a composite of TMC and glycolide block copolymer, and polydioxanone.

[0092] The net bag is made of natural polymer bioabsorbable material, such as polyoxyalkanoate, collagen, chitin and alginic acid. The present invention does not specifically limit the structure of the net bag, as long as the net bag structure disclosed in the prior art or undisclosed in the new technology can be used in the present invention as long as it can achieve the function of capturing the target tissue, for example, the net bag structure disclosed in the prior art such as CN118680620A, CN117357188A, CN217566257U can be used in the present invention.

[0093] Example 1

[0094] This embodiment provides a pre-tightening positioning device, including a support assembly and a tightening wire 3. The support assembly includes a sleeve ring body 1 and a bent connecting portion. Figure 1 , Figure 2 and Figure 3 As shown, the sleeve ring body 1 is elliptical, with a long axis length of 45 mm and a short axis length of 20 mm. The sleeve ring body 1 is surrounded by a flexible spring tube, and a nickel-titanium wire is arranged inside the flexible spring tube. The bending connection portion includes two connecting rods 11, one end of the two connecting rods 11 intersects (such as Figure 3 The two connecting rods 11 intersect at the intersection point a shown in the figure) and are respectively connected to the sleeve ring body 1, and the other ends of the two connecting rods 11 extend parallel to the distal end. A plurality of positioning grooves are opened along the circumference of the inner ring surface of the sleeve ring body 1, and an elastic inner connecting piece 2 is independently embedded in each positioning groove, and the elastic inner connecting piece 2 is welded and fixed to the positioning groove. The elastic inner connecting piece 2 is a cylindrical elastic braided body with an active cavity arranged inside. The height of the elastic inner connecting piece 2 is 8mm, the outer diameter is 5mm, and the wall thickness is 1.5mm. The material of the elastic inner connecting piece 2 is biocompatible silicone, which contains polybrominated biphenyl components. The tightening line 3 passes through the active cavities of the plurality of elastic inner connecting pieces 2 along the circumference of the sleeve ring body 1, and slides relatively inside the active cavity, and the end of the tightening line 3 extends from the distal end. The tightening line 3 is made of bovine pericardium material, and its outer surface is covered with a reinforcing layer of polytetrafluoroethylene material. As shown Figure 2 , Figure 4 and Figure 5 As shown, an elastic outer connecting member 4 is also provided on the outside of the sleeve ring body 1. The elastic outer connecting member 4 is an elastic braided body made of biocompatible silicone, which wraps the sleeve ring body 1, the elastic inner connecting member 2 and the tightening line 3, and is fixed by glue.

[0095] Example 2

[0096] This embodiment provides a tissue ligation system device, such as Figure 6As shown, it includes a push sheath 5, a push knot assembly, a ligature, a net bag and a pre-tightening positioning device. The pre-tightening positioning device is exactly the same in structure as the pre-tightening positioning device provided in Example 1, and will not be repeated here. The push sheath 5 includes a plurality of lumens, one of which is connected to the bent connection part of the support assembly, so that the sleeve ring body 1 can be received in the lumen, and unfolded in the body to pre-tighten the target tissue, and the net bag is fixed on the sleeve ring body 1 along the circumferential direction; one lumen is connected to the end of the tightening line 3, which can control the tightening and relaxation of the tightening line 3; one lumen is connected to the ligature, which is used to ligate the target tissue; one lumen is connected to the push knot assembly, which is used to push and shear the ligature. The push knot assembly includes a nested movable inner tube 7 and an outer sleeve 8, one end of the movable inner tube 7 extends out of the outer sleeve 8, and is provided with a proximal guide 6, which is located at the upper end of the intersection a of the two connecting rods 11 and is in the same horizontal plane as the intersection a. The inner diameter of the proximal guide part 6 is 0.5 mm, and a passivation layer is provided on its surface. The end of the outer sleeve 8 away from the proximal guide part 6 is connected to the push sheath tube 5. The outer wall of the movable inner tube 7 is provided with a first blade 9, and the first blade 9 is located on the side close to the proximal guide part 6. The end of the outer sleeve 8 close to the proximal guide part 6 is provided with a second blade 10, and the second blade 10 is arranged opposite to the first blade 9. The surface of the movable inner tube 7 is provided with a lead groove, and the lead groove is located between the first blade 9 and the second blade 10. One end of the ligature is arranged along the circumference of the net bag, and the other end is introduced into a lumen of the push sheath tube 5 after passing through the lead groove, for ligating the target tissue. A ligature knot is provided on the ligature, and the ligature knot is arranged close to the port of the proximal guide part 6. The maximum diameter of the proximal guide part 6 is smaller than the caliber of the ligature knot. When in use, the extension line of the ligature at the rear end of the ligature knot is cut by the cooperation of the first blade 9 and the second blade 10.

[0097] The use process of this embodiment specifically includes the following steps:

[0098] (1) Move the push sheath 5 to the front end of the diseased tissue, release the sheath ring body 1 and the net bag to capture the target tissue, and start tightening the tightening line 3 from the distal end, so that the elastic inner connecting member 2 is stretched circumferentially and approaches the target tissue, and the elastic outer connecting member 4 undergoes elastic deformation at the same time to pre-tighten the target tissue and feed back a force value to the operator; then relax the distal end of the tightening line 3, so that the elastic inner connecting member 2 and the elastic outer connecting member 4 are reset through their own elasticity, and feed back a force value to the operator to release the target tissue, and repeat tightening and releasing to ensure that the sheath ring body 1 successfully sheathes the target tissue and achieves one-time positioning of the target tissue.

[0099] (2) The ligature knot is moved 5 mm by the knot pusher assembly to achieve secondary positioning of the target tissue, and the root of the target tissue is ligated with the ligature. The ligature passing through the lead groove is sheared with the first blade 9 and the second blade 10 to complete the cutting of the ligature.

[0100] (3) The push sheath 5 is then withdrawn as a whole, and finally angiography is performed to verify that the ligation of the diseased tissue is successful.

[0101] The present invention utilizes the elastic design of the elastic inner connecting member 2 and the elastic outer connecting member 4 to capture and tighten the target tissue for one-time positioning before tissue ligation, and through repeated tightening and releasing, confirm whether the support component has successfully captured the target tissue, and then utilize the knot-pushing function to perform secondary positioning on the captured target tissue, which has double protection and realizes the integration of tissue positioning, capture and ligation, and the knot-pushing component has a shearing function, which reduces the number of instruments entering the body, reduces the risk of bleeding, and improves the success rate of the operation.

[0102] 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 pre-tightening and positioning device, characterized in that: The pre-tightening positioning device comprises a support assembly and a tightening line, wherein the support assembly has a distal end and a proximal end, and the support assembly comprises a sleeve ring body, and a plurality of elastic inner connecting members are arranged circumferentially along the inner ring surface of the sleeve ring body, and the tightening line passes through the plurality of elastic inner connecting members in sequence, and the end of the tightening line extends out from the distal end of the support assembly, and when in use, the tightening line is pulled by the distal end to drive the plurality of elastic inner connecting members to stretch circumferentially in a direction close to the target tissue; The outer surface of the support component is provided with an elastic outer connecting piece, which wraps the support component, the elastic inner connecting piece and the tightening line. The elastic outer connecting piece and the elastic inner connecting piece are elastically deformed synchronously. When in use, the tightening line is loosened from the far end, and the elastic outer connecting piece and the elastic inner connecting piece rely on their own elastic reset to loosen the target tissue.

2. The pre-tightening and positioning device according to claim 1, characterized in that: A plurality of positioning grooves are provided along the inner ring surface of the sleeve ring body, and the elastic inner connecting member is at least partially located in the positioning grooves; The sleeve ring body is connected to the elastic inner connecting piece by screws, snaps, welding or bonding.

3. The pre-tightening and positioning device according to claim 2, characterized in that: The distal end of the support assembly is also provided with a bent connection portion; The bent connection portion includes two connecting rods, one end of the two connecting rods intersects and is respectively connected to the sleeve ring body, and the other ends of the two connecting rods extend in parallel to the distal end; The material of the sleeve ring is elastic metal; The sleeve ring body is an elliptical ring body or a perfect circular ring body.

4. The pre-tightening and positioning device according to claim 1 or 2, characterized in that: An active cavity is provided inside the elastic inner connecting member, and the tightening wire passes through the active cavity and slides relatively along the inside of the active cavity; The elastic inner connecting member is an elastic sleeve, an elastic braid or an elastic film; The elastic inner connecting piece is made of biocompatible elastic material.

5. The pre-tightening and positioning device according to claim 1, characterized in that: The elastic external connecting member is connected to the supporting assembly by screws, snaps, welding or bonding; The elastic outer connecting member is independently connected to the elastic inner connecting member and the tightening wire by screws or snaps; The elastic external connecting piece is made of biocompatible elastic material; The elastic external connecting piece is an elastic sleeve, an elastic braided body or an elastic film.

6. The pre-tightening and positioning device according to claim 1, characterized in that: The material of the tightening line is polyester material, fluoropolymer or animal pericardium material; The outer surface of the tightening wire is coated with a reinforcement layer; The reinforcement layer is made of polymer material or metal material.

7. A tissue ligation system device, characterized in that: The tissue ligation system device includes a push sheath, a knot pusher assembly, a ligature, a net bag and the pre-ligation positioning device described in any one of claims 1 to 6, wherein the push sheath is movably connected to the distal end of the support assembly, the tightening line, the knot pusher assembly and the ligature, and the net bag is connected to the proximal end of the support assembly.

8. The tissue ligation system device according to claim 7, characterized in that: The pushing sheath tube includes a plurality of lumens.

9. The tissue ligation system device according to claim 8, characterized in that: The push-knot assembly comprises a nested movable inner tube and an outer tube, one end of the movable inner tube extends out of the outer tube and is provided with a proximal guide portion, and one end of the outer tube away from the proximal guide portion is movably connected to the push sheath tube; The outer wall of the movable inner tube is provided with a first blade, and the first blade is located at a side close to the proximal guide portion; A second blade is disposed at one end of the outer sleeve close to the proximal guide portion, and the second blade is disposed opposite to the first blade; A wire guide groove is provided on the surface of the movable inner tube, and the wire guide groove is located between the first blade and the second blade; One end of the ligature is arranged along the circumference of the net bag, and the other end of the ligature is passed through the lead groove and then introduced into the push sheath tube for ligating the target tissue; The ligature line is provided with a ligature knot, the ligature knot is provided close to the end of the proximal guide portion, and the maximum diameter of the proximal guide portion is smaller than the caliber of the ligature knot; The ligature and the net bag are respectively made of bioabsorbable materials.

10. The tissue ligation system device according to claim 9, characterized in that: The push-knot assembly is located at the upper end or the lower end of the intersection of the bent connection portion of the support assembly; A passivation layer is provided on the surface of the proximal guide portion.

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