Line locking and trimming integrated handle and plugging device conveying and forming device

Abstract

The invention discloses a thread locking and trimming integrated handle and a plugging device conveying and forming device.The integrated handle comprises a shell, a thread locking assembly, a tensioning assembly and a thread trimming push button, a multi-cavity tube fixing ring and a thread guiding device are fixedly arranged in the shell, and the multi-cavity tube fixing ring is used for fixing a multi-cavity tube; a core rod sliding block is further arranged in the shell in the mode that the core rod sliding block can axially move along the center of the front end hole, and the core rod sliding block is used for being connected with a core rod. The wire locking assembly penetrates through the upper wall hole and is used for clamping and loosening a forming wire guided by the wire leading hole of the wire leading device. The tensioning assembly penetrates through the rear end hole and is used for tensioning and loosening the tensioning wire; the trimming push button slidably penetrates through the side sliding hole, is connected with the core rod sliding block and is used for driving the core rod sliding block to move back and forth relative to the multi-cavity pipe. The wire tensioning assembly, the wire locking assembly and the wire cutting assembly are integrated on the wire locking and wire cutting integrated handle, the steps of wire locking, tensioning and wire cutting can be completed by operating on the wire locking and wire cutting integrated handle, and the operation difficulty and risk can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a thread locking and thread cutting integrated handle and an occluder conveying and forming device. Background Art

[0002] Among medical devices, releasing occluders is a very common implantable procedure, especially for cardiovascular diseases. There are two types of occluders currently available: metal occluders and biodegradable occluders. Due to the unique self-expanding properties of nickel-titanium alloy, metal occluders automatically form after being released from the delivery sheath. Once formed, they can be released by simply loosening the core rod. However, the future development trend is towards biodegradable occluders. Because the material of biodegradable occluders is inelastic, they need to be pulled into shape using a molding wire, and the delivery system is generally more complex.

[0003] The shortcomings of the occluder delivery and molding device in the prior art when in use are as follows:

[0004] 1. The operation process of existing biodegradable occluders is relatively complicated, requiring doctors to assemble and operate them during surgery. The operation is more cumbersome and not conducive to clinical operation. The doctor also has a long learning curve, especially the process of tightening and cutting the molding wire is more cumbersome.

[0005] 2. Existing occluder delivery systems usually consist of a steel cable, an outer sheath, and a loader. At the end of the operation, the doctor needs to use scissors to cut the forming wire and tensioning wire, and continue to pull the wire until it is out of the human body. This is more troublesome and involves certain risks. Summary of the Invention

[0006] In view of this, the present invention proposes a locking wire and cutting integrated handle and an occluder delivery and molding device, which integrates the tensioning wire assembly, the locking wire assembly and the cutting assembly on the locking wire and cutting integrated handle. The above steps can be completed by operating on the locking wire and cutting integrated handle, thereby reducing the difficulty and risk of the operation.

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

[0008] A thread locking and thread trimming integrated handle, comprising:

[0009] The shell is provided with a front end hole, a side sliding hole, an upper wall hole, an upper wire hole and a rear end hole, the upper wire hole is used for the molding wire to enter and exit the shell, a multi-lumen tube fixing ring and a wire guide are fixed in sequence from front to back in the shell, the center hole of the multi-lumen tube fixing ring and the front part of the wire guide hole of the wire guide are both coaxially arranged with the front end hole, the multi-lumen tube fixing ring is used to fix the multi-lumen tube extending into the shell from the front end hole, and a mandrel slider located behind the wire guide is further provided in the shell in a manner that can move axially along the center of the front end hole, the mandrel slider is used to connect the mandrel inserted into the shell through the front end hole, the center hole of the multi-lumen tube fixing ring and the wire guide hole of the wire guide;

[0010] A wire locking assembly, which passes through the upper wall hole and is used to clamp and release the molding wire guided through the wire guide hole of the wire guide;

[0011] A tensioning assembly, which passes through the rear end hole and is used to tighten and loosen the tensioning line;

[0012] and a thread trimming push button, which slides through the side sliding hole and is connected to the core rod slider, and is used to drive the core rod slider to move back and forth relative to the multi-lumen tube.

[0013] To better implement the above technical solution, optionally, the rear end of the wire guide hole has a guide groove inclined upward, the rear side of the guide groove is an open end, and the molding wire is led out from the upper wire hole after passing through the guide groove.

[0014] Optionally, the locking wire assembly includes:

[0015] A fixing seat, the fixing seat is fixedly arranged at the upper part of the shell, the upper part of the fixing seat is provided with a strip groove, and the rear end of the strip groove is provided with a stop platform;

[0016] A wire pressing slider is slidably arranged in the strip groove, a first through hole is vertically opened in the middle of the wire pressing slider, and the inner wall of the rear side of the first through hole is a first inclined surface;

[0017] A thread locking button, the thread locking button having a second inclined surface that slides with the first inclined surface;

[0018] and a wire pressing spring, wherein the front end of the wire pressing spring abuts against the rear end of the wire pressing slider, and the rear end abuts against the inside of the housing;

[0019] When the wire locking assembly is in the wire locking state, the wire pressing slider is pushed forward by the wire pressing spring, and the front end of the wire pressing slider is pressed against the guide groove, and the molding wire is clamped there; when the wire locking assembly is in the non-wire locking state, the wire locking button moves downward to push the wire pressing slider backward, and the front end of the wire pressing slider is disengaged from the guide groove, so that the molding wire is released, and the wire pressing spring is in a strongly compressed state.

[0020] Optionally, the left and right side walls of the guide groove are provided with guide grooves for the front portion of the wire pressing slider to slide back and forth.

[0021] Optionally, the wire locking assembly further comprises a mounting ring, an unlocking button and a torsion spring, wherein the mounting ring is rotatably arranged below the front portion of the fixing seat, a limiting protrusion is radially fixedly provided on the outer peripheral wall of the mounting ring, the unlocking button movably passes through the shell and is fixedly connected to the mounting ring, the torsion spring is sleeved on the mounting ring, and one end of the torsion spring is clamped on the mounting ring and the other end is clamped in the shell, the fixing seat is provided with an avoidance hole for the wire locking button to move downward, and a limiting groove is provided in the middle of the front end of the wire locking button to cooperate with the limiting protrusion;

[0022] When the wire locking assembly is in the wire locking state, the limiting groove moves upward with the wire locking button, the limiting protrusion abuts against the side wall of the wire locking button, and the wire pressing slider is pushed forward by the wire pressing spring, and the front end of the wire pressing slider is pressed against the guide groove; when the wire locking assembly is in the non-wire locking state, the front end of the wire pressing slider is disengaged from the guide groove, and the limiting protrusion rotates with the mounting ring and is stuck in the limiting groove to limit the forward movement of the wire pressing slider, so that the forming line is loosened.

[0023] Optionally, the limiting protrusion is a fan-shaped structure.

[0024] Optionally, the tensioning assembly includes a knob and a wire post, the knob rotates through the rear end hole in a damped manner, the wire post is fixed in the shell, and both ends of the tensioning wire pass around the wire post and are fixed to the side wall of the knob.

[0025] Optionally, a plurality of radially extending connecting protrusions are evenly distributed on the outer peripheral wall of the front portion of the knob, and both ends of the tensioning wire pass around the wire post and are connected to the plurality of connecting protrusions.

[0026] Optionally, an anti-foolproof buckle is further included, the housing and the thread trimming push button are both provided with a fixing groove, and the anti-foolproof buckle is provided with a fixing protrusion that is buckled and connected to each fixing groove.

[0027] An occluder delivery and molding device comprises any one of the above-mentioned integrated handles for locking and cutting wires, and also comprises an occluder pushing mechanism, wherein the occluder pushing mechanism comprises:

[0028] an occluder, the occluder comprising a shaped knot;

[0029] A multi-lumen tube having a central channel and at least one side channel concentric with the central channel, a sheath fixedly covering the front end of the central channel, and a first slot formed on a side wall of the sheath;

[0030] A mandrel, wherein the mandrel is provided with a central passage in a manner that allows forward and backward movement and prevents rotation, a wire cutting tube located in a sheath is fixedly provided at the front end of the mandrel, a second slot is provided at the front end of the wire cutting tube, and a rear end of the mandrel is fixedly provided in the central hole of the mandrel slider;

[0031] A forming line, one end of which enters from the upper line hole, passes through the guide groove, the side channel, the forming knot, the second slot hole, the first slot hole, the side channel and the guide groove, and is led out from the upper line hole;

[0032] and a tensioning wire, one end of which is fixed to the tensioning assembly, and the other end of which passes through the side channel, winds around the occluder, the second slot, the first slot, and the side channel, and is then fixed to the tensioning assembly;

[0033] Wherein, at least one edge portion of the first slot and the second slot is provided with a cutting edge, and the core rod can be moved relative to the multi-lumen tube along the axial direction of the central channel to cause the second slot to be misaligned with the first slot, thereby cutting the forming line and the tensioning line through the cutting edge.

[0034] Beneficial effects of the present invention:

[0035] The occluder delivery and molding device of the present invention has the following technical effects:

[0036] 1. Adopting an integrated structure with integrated locking, shaping and cutting functions, and pre-assembling the occluder and delivery system into one, it reduces clinical operation steps; through functional integrated design, it optimizes the operation process, reduces the complexity of operation, and thus improves the efficiency and safety of surgery.

[0037] 2. The thread locking, shaping, and trimming functions are configured into an integrated handle, which can simultaneously complete the tensioning wire pre-tightening, shaping wire shaping, and tensioning / forming wire trimming operations, allowing the surgeon to complete the handle operation alone. This structure effectively shortens the operation time, reduces the radiation exposure of the surgeon and patient, and improves the accuracy of the operation.

[0038] 3. The integrated handle is equipped with different buttons, push buttons, knobs and anti-foolproof structures, which make it convenient for doctors to directly identify functions and avoid surgical problems caused by misoperation. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 This is a three-dimensional schematic diagram of the thread locking and trimming integrated handle of Example 1 of the present invention;

[0040] Figure 2 yes Figure 1 Exploded diagram;

[0041] Figure 3 yes Figure 1 sectional view of

[0042] Figure 4 yes Figure 2 Exploded view of the wire guide and wire lock assembly;

[0043] Figure 5 yes Figure 1 Installation diagram of the middle trimmer push button;

[0044] Figure 6 This is a front view of an occluder delivery and molding device according to embodiment 2 of the present invention;

[0045] Figure 7 yes Figure 6 Front view of the pushing mechanism of the middle occluder;

[0046] Figure 8 yes Figure 7 Schematic diagram of the occluder;

[0047] Figure 9 yes Figure 8 Schematic diagram of the middle occluder from the initial structure to the first-level occlusion form;

[0048] Figure 10 yes Figure 8 Schematic diagram of the middle occluder from the initial structure to the second-level occlusion form;

[0049] Figure 11 yes Figure 7 Exploded diagram;

[0050] Figure 12 yes Figure 11 A three-dimensional schematic diagram of the middle structure at the first angle;

[0051] Figure 13 yes Figure 11 A three-dimensional schematic diagram of the middle structure from a second angle;

[0052] Figure 14 This is a schematic diagram of the cooperation between the sheath and the sheath tube (the sheath and the sheath tube coincide radially, and the forming line and the tensioning line are both one line);

[0053] Figure 15 It is a schematic diagram of the cooperation between the sheath and the shear tube (the sheath and the shear tube are radially offset to cut the forming line and the tensioning line).

[0054] Reference numerals:

[0055] Occluder pushing mechanism 100, occluder 110, left umbrella disc 111, right umbrella disc 112, forming knot 113, forming knot 1131, hollow waist 114, hollow hot-melt tail 115, flow-blocking membrane 116, multi-lumen tube 120, central channel 121, side channel 122, sheath 130, cylindrical tapered section 131, straight section 132, first slot 133, strip guide slot 134, first lead hole 135, second lead hole 136, mandrel 140, small-diameter portion 141, wire cutting tube 150, second slot 151, guide protrusion 152, forming wire 160, tensioning wire 170;

[0056] Thread lock and trimmer integrated handle 200, housing 210, front cover 211, front hole 2111, upper housing 212, upper wall hole 2121, upper thread hole 2122, side sliding hole 2123, rear end hole 2124, anti-rotation clamping strip 2125, fixed clamping column 2126, clamping plate guide rail 2127, damping wall 21271, rotating convex ring 2128, lower housing 213, annular body 221, locking protrusion 222, locking groove 223, thread guide 230, thread guide hole 231, first guide groove 232, convex ring 233, mandrel slider 240, guide slider 241, thread lock assembly 250, Fixed seat 251, strip groove 2511, stop platform 2512, avoidance hole 2513, connecting column 2514, wire pressing slider 252, first through hole 2521, first inclined surface 2522, pressing portion 2523, wire locking button 253, second inclined surface 2531, limiting groove 2532, wire pressing spring 254, mounting ring 255, limiting protrusion 2551, unlocking button 256, torsion spring 257, wire trimming push button 260, knob 271, ring groove 2711, damping protrusion 2712, connecting protrusion 2713, wire post 272, anti-fouling buckle 280, fixing protrusion 281. DETAILED DESCRIPTION

[0057] The technical solution of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments, wherein the same components are represented by the same reference numerals.

[0058] Example 1

[0059] See also Figures 1 to 5 This embodiment discloses a thread locking and thread trimming integrated handle 200, including a housing 210, a thread locking assembly 250, a tensioning assembly, and a thread trimming push button 260.

[0060] like Figures 1 to 3As shown, the shell 210 is provided with a front end hole 2111, a side sliding hole 2123, an upper wall hole 2121, an upper line hole 2122 and a rear end hole 2124, wherein the front end hole 2111 is used to pass through the multi-lumen tube, the side sliding hole 2123 is used to assemble the line cutting button 260, the upper wall hole 2121 is used to assemble the line locking assembly 250, and the upper line hole 2122 is used for the forming line 160 to enter and exit the shell 210.

[0061] In the embodiment, in order to facilitate the installation of components in the shell 210, the shell 210 is assembled by the front cover 211, the upper shell 212 and the lower shell 213. The shell 210 is a common structure that meets the assembly requirements, and the specific structure is not repeated here.

[0062] like Figure 2 As shown, a multi-lumen tube fixing ring and a wire guide 230 are fixed in sequence in the shell 210 from front to back. The center hole of the multi-lumen tube fixing ring and the front part of the wire guide hole 231 of the wire guide are both coaxially arranged with the front end hole 2111. The multi-lumen tube fixing ring is used to fix the multi-lumen tube extending from the front end hole 2111 into the shell 210.

[0063] Specifically, the multi-lumen tube fixing ring includes an annular body 221 and two locking protrusions 222 symmetrically fixed on the outer wall of the middle part of the annular body 221 along the central axis of the annular body 221. A locking groove 223 is formed between the two locking protrusions 222. The outer shell 210 is provided with a first installation groove for limiting the multi-lumen tube fixing ring (including an upper half arranged in the upper shell 212 and a lower half arranged in the lower shell 213) and an anti-rotation clip 2125 that is engaged with the locking groove 223. The center hole of the annular body 221 is used to fix the rear end of the multi-lumen tube 120 extending from the front end hole 2111 into the outer shell 210, so that the rear end of the multi-lumen tube is fixed in the outer shell.

[0064] like Figure 2 and Figure 3 As shown, the rear end of the wire guide hole 231 of the wire guide has a guide groove inclined upward, and the rear side of the guide groove is an open end. The molding wire 160 passes through the guide groove and is led out from the upper wire hole 2122.

[0065] like Figure 2 and Figure 4 As shown, at least one convex ring 233 is fixed to the upper and lower sides of the front end of the wire guide 230 , and a second mounting groove for placing the wire guide 230 and a fixing column 2126 for clamping each convex ring 233 are provided in the housing 210 .

[0066] In an embodiment, two convex rings 233 are fixedly provided at intervals on the upper and lower sides of the front end of the wire guide 230, and the upper shell 212 and the lower shell 213 are respectively integrally provided with fixed clamping columns 2126 corresponding to the convex rings 233. The wire guide 230 is fixed in the outer shell 210 by utilizing the fixed clamping columns 2126 and the convex rings 233.

[0067] like Figure 2 As shown, a core rod slider 240 is provided in the shell 210 and is located behind the guide wire device 230 in a manner that it can move axially along the center of the front end hole 2111. The core rod slider 240 is used to connect the core rod 140 inserted into the shell 210 through the front end hole 2111, the center hole of the multi-lumen tube fixing ring, and the guide wire device guide hole 231.

[0068] like Figure 2 As shown, the locking wire assembly 250 passes through the upper wall hole 2121, and is used to clamp and release the molding wire 160 guided by the wire guide hole 231; the tensioning assembly passes through the rear end hole 2124, and is used to tighten and loosen the tensioning wire 170; the wire cutting push button 260 slides through the side sliding hole 2123 and is connected to the mandrel slider 240, and is used to drive the mandrel slider 240 relative to the multi-lumen tube 120 ( Figure 12 Move forward and backward) with specific numbers.

[0069] like Figure 4 As shown, the wire locking assembly 250 includes a fixing seat 251 , a wire pressing slider 252 , a wire locking button 253 and a wire pressing spring 254 .

[0070] Among them, the fixing seat 251 is fixed to the upper part of the upper shell 212 by two screws, and a strip groove 2511 is opened in the front-to-back direction of the upper part of the fixing seat 251, and a stop platform 2512 is provided at the rear end of the strip groove 2511. The wire pressing slider 252 is slidably set in the strip groove 2511, and a first through hole 2521 is vertically opened in the middle part of the wire pressing slider 252. The inner wall of the rear side of the first through hole 2521 is a first inclined surface 2522; the wire locking button 253 has a second inclined surface 2531 that slides with the first inclined surface 2522; the front end of the wire pressing spring 254 abuts against the rear end of the wire pressing slider 252, and the rear end abuts against the inside of the shell 210.

[0071] When the wire locking assembly 250 is in the wire locking state, the wire pressing slider 252 is pushed forward by the wire pressing spring 254, and the front end of the wire pressing slider 252 is pressed against the guide groove and clamps the forming wire 160 there; when the wire locking assembly 250 is in the non-wire locking state, the wire locking button 253 moves downward and pushes the wire pressing slider 252 backward, and the front end of the wire pressing slider 252 disengages from the guide groove to unlock the forming wire 160, and the wire pressing spring 254 is in a strongly compressed state.

[0072] Specifically, the wire locking button 253 is pressed, and the wire locking button 253 moves downward and cooperates with the first inclined surface 2522 through the second inclined surface 2531, driving the wire pressing slider 252 to move backward until it stops against the stop platform 2512. During this process, the wire pressing spring 254 is converted from a weak compression state to a strong compression state, and the wire pressing slider 252 disengages from the guide groove to release the forming line 160. When the wire locking button 253 is released, the wire pressing spring 254 is converted from a strong compression state to a weak compression state and pushes the wire pressing slider 252 to move forward until the front end of the wire pressing slider 252 is pressed against the guide groove and clamps the forming line 160 here.

[0073] like Figure 4 As shown, the left and right side walls of the guide groove are provided with guide grooves 232 for the front part of the wire pressing slider 252 to slide back and forth, and the front part of the wire pressing slider 252 is provided with a pressing portion 2523 that cooperates with the guide groove 232. The width of the pressing portion 2523 is smaller than the width of the wire pressing slider 252. The provision of the pressing portion 2523 and the guide groove 232 can enable the wire pressing slider 252 to move precisely, thereby improving the reliability of the wire locking assembly 250 in clamping and fixing the forming line 160.

[0074] like Figure 4 As shown, the locking wire assembly 250 also includes a mounting ring 255, an unlocking button 256 and a torsion spring 257. A connecting column 2514 is integrally provided on the bottom surface of the front part of the fixing seat 251. The mounting ring 255 can be rotatably sleeved on the connecting column 2514. A limiting protrusion 2551 is radially fixed to the outer peripheral wall of the mounting ring 255. The unlocking button 256 can move through the shell 210 and is fixedly connected to the mounting ring 255. The torsion spring 257 is sleeved on the mounting ring 255, and one end of the torsion spring 257 is clamped on the mounting ring 255, and the other end is clamped in the shell 210. An avoidance hole 2513 for the locking wire button 253 to move downward is opened in the strip groove 2511 of the fixing seat 251, and a limiting groove 2532 is provided in the middle of the front end of the locking wire button 253 to cooperate with the limiting protrusion 2551.

[0075] When the wire locking assembly 250 is in the wire locking state, the limiting groove 2532 moves up with the wire locking button 253, and the limiting protrusion 2551 abuts against the side wall of the wire locking button 253. Under the forward pushing action of the wire pressing spring 254, the front end of the pressing portion 2523 of the wire pressing slider 252 is pressed in the guide groove; when the wire locking assembly 250 is in the non-wire locking state, the front end of the pressing portion 2523 is disengaged from the guide groove, and the limiting protrusion 2551 rotates with the mounting ring 255 and is clamped in the limiting groove 2532 to limit the forward movement of the wire pressing slider 252, so that the forming line 160 is loosened.

[0076] In the embodiment, the limiting protrusion 2551 is a fan-shaped structure, and the openings on the left and right sides of the limiting groove 2532 are flared structures. The limiting protrusion 2551 with a fan-shaped structure and the limiting groove 2532 with a flared structure are provided to facilitate the limiting protrusion 2551 to enter and exit the limiting groove 2532.

[0077] like Figure 3 and 4 As shown, guide sliders 241 are symmetrically fixed to the upper and lower ends of the core rod slider 240, and clamping guide rails 2127 with damping sliding with the guide slider 241 are respectively fixed in the upper shell 212 and the lower shell 213. The provision of the clamping guide rails 2127 and the guide slider 241 can make the core rod slider 240 move forward and backward more accurately.

[0078] like Figure 2 As shown, the tensioning assembly includes a knob 271 and a wire post 272. The knob 271 rotates through the rear end hole 2124 in a damped manner. The wire post 272 is fixed in the housing 210. The two ends of the tensioning wire 170 pass around the wire post 272 and are fixed to the side wall of the knob 271.

[0079] Specifically, the knob 271 is a cylindrical structure, and two retaining rings are provided at intervals in the front and rear of the middle part of the knob 271, and a ring groove 2711 is formed between the two retaining rings. The outer shell 210 is provided with a rotating convex ring 2128 adapted to the ring groove 2711 around the rear end hole 2124, and the rotating convex ring 2128 rotates with the ring groove 2711 to allow the knob 271 to rotate around the central axis of the rear end hole 2124. A plurality of axially extending damping ridges 2712 are circumferentially spaced apart on the outer peripheral wall at the front end of the knob 271, and a damping wall 21271 is provided on the inner wall of the outer shell 210 for damping cooperation with the damping ridge 2712 (the damping wall 21271 is arranged at the rear end of the splint guide rail 2127). Through the cooperation between the damping ridge 2712 and the damping wall 21271, the rotational resistance of the knob 271 can be kept moderate.

[0080] In an embodiment, a plurality of radially extending connecting protrusions 2713 are evenly distributed on the front outer peripheral wall of the knob 271, and the connecting protrusions 2713 are located on the rear side of the damping protrusion 2712. The two ends of the tensioning wire 170 pass around the wire column 272 and are connected to the plurality of connecting protrusions 2713. Specifically, the two ends of the tensioning wire 170 are knotted and fixed with the plurality of connecting protrusions 2713, which increases the stability of the connection between the tensioning wire 170 and the knob 271, and at the same time facilitates the rotation of the knob 271 to drive the tensioning wire 170 to tighten and loosen.

[0081] In the embodiment, an anti-mistake buckle 280 is further included. Both the housing 210 and the thread trimmer push button 260 are provided with fixing grooves. The anti-mistake buckle 280 is provided with fixing protrusions 281 that are engaged with the fixing grooves.

[0082] like Figure 5As shown, the fixing groove of the thread trimmer push button 260 is set on the outer wall of the thread trimmer push button 260, the fixing groove of the shell 210 is connected to the fixing groove of the thread trimmer push button 260, and the fixing protrusion 281 of the anti-fool buckle 280 is embedded in the fixing groove of the thread trimmer push button 260 and the fixing groove of the shell 210 at the same time, so that the thread trimmer push button 260 is locked. When it is necessary to push the thread trimmer push button 260 to slide, it is only necessary to buckle the anti-fool buckle 280.

[0083] Example 2

[0084] like Figure 6 As shown, an occluder delivery and molding device includes an occluder pushing mechanism 100 and a thread locking and thread cutting integrated handle 200.

[0085] like Figure 7 As shown, the occluder pushing mechanism 100 includes an occluder 110 , a multi-lumen tube 120 , a core rod 140 , a forming wire 160 and a tension wire 170 .

[0086] like Figures 8-10 As shown, the occluder 110 includes a molded knot 1131. Specifically, the occluder 110 includes a left umbrella disc 111, a right umbrella disc 112, a molded knot line 113, and a hollow waist 114 connecting the left umbrella disc 111 and the right umbrella disc 112. A hollow hot-melt tail end 115 connected to the hollow waist 114 is provided at the center of one end of the right umbrella disc 112 away from the left umbrella disc 111. One end of the molded knot line 113 is fixed in the left umbrella disc 111, and the other end is sequentially wrapped around the left umbrella disc 111, passes through the hollow waist 114 and forms a molded knot 1131 in the hollow hot-melt tail end 115. After the molded knot 1131 is pulled out of the hollow waist 114, it automatically expands and seals in the hollow hot-melt tail end 115 or seals at the lower end of the hollow hot-melt tail end 115. Both the left umbrella disc 111 and the right umbrella disc 112 are equipped with a flow-blocking membrane 116.

[0087] In this embodiment, the left umbrella disc 111, the waist 114, the right umbrella disc 112, the hollow hot-melt tail end 115 and the molding knot line 113 are all made of PDO material, wherein the left umbrella disc 111, the waist 114 and the right umbrella disc 112 are woven and formed by a weaving machine, and after weaving, they are placed in a drying box at a certain temperature for shaping through a shaping tool, and the hollow hot-melt tail end 115 is shaped by a hot-melt welding machine. The flow-blocking membrane 116 is made of PLCL material, and the two flow-blocking membranes 116 are sewn into the left umbrella disc 111 and the right umbrella disc 112 of the occluder 110 with degradable PDO material.

[0088] In this embodiment, the aperture of the central channel of the hollow hot melt tail end 115 is larger than the aperture of the central channel of the right umbrella plate 112. The central channel of the right umbrella plate 112 is used to pass the forming line 113. The occluder 110 has a two-stage adjustment mode, such as Figure 9As shown, the forming knot 1131 is placed in the central channel of the hollow hot melt tail 115 to form the first level of adjustment; Figure 10 As shown, the molding knot 1131 is placed outside the central channel of the hollow hot-melt tail end 115 to form a second-level adjustment, wherein the second-level adjustment is suitable for normal heart thickness, and the first-level adjustment is suitable for patients with hypertrophic fossa ovale. For patients with hypertrophic fossa ovale, the first-level adjustment method can avoid forced tightening of the molding knot 1131 and causing the molding knot 1131 to slip, thereby further avoiding the waste of the occluder 110 caused by replacing the occluder 110 due to the slipping of the molding knot 1131 during clinical surgery.

[0089] The forming method of the occluder 110 in the embodiment of the present invention is as follows: when the occluder 110 enters the heart, the left umbrella disc 111 and the right umbrella disc 112 are respectively in the left atrium and the right atrium of the heart, and the shape of the occluder 110 has reached the desired state, but because the material of the occluder 110 does not have the same self-forming property as metal, it is necessary to pull the forming wire 160 to drive the forming knot 1131 to move downward. When the forming knot 1131 reaches the hollow hot-melt tail end 115, the expansion of the forming knot 1131 increases and it is stuck in the hollow hot-melt tail end 115, forming a primary occlusion (such as Figure 9 As shown), continue to pull the forming knot 1131 downward, and the forming knot 1131 is stuck outside the hollow hot melt tail end 115 to form a secondary blockage (as shown Figure 10 As shown), the occluder 110 is finally formed.

[0090] like Figure 11-13 As shown, the multi-lumen tube 120 has a central channel 121 and at least one side channel 122 concentric with the central channel 121. The front end of the central channel 121 is fixedly covered with a sheath 130, and the side wall of the sheath 130 is provided with a first slot 133;

[0091] The mandrel 140 is inserted into the central passage 121 in a manner that allows it to move forward and backward and is fixed to rotation. The front end of the mandrel 140 is fixedly provided with a wire cutting tube 150 located in the sheath 130. The front end of the wire cutting tube 150 is provided with a second slot 151. The rear end of the mandrel 140 is fixedly provided in the central passage of the mandrel slider 240.

[0092] Specifically, the wire cutting tube 150 and the core rod 140 are both made of stainless steel. The front end of the core rod 140 has a small diameter portion 141. The rear end of the wire cutting tube 150 is sleeved on the small diameter portion 141 of the core rod 140 and fixed by laser welding, so that the wire cutting tube 150 and the core rod 140 form an integral structure.

[0093] One end of the forming line 160 enters from the upper line hole 2122, passes through the guide groove, the side channel 122, the forming knot 1131, the second slot hole 151, the first slot hole 133, the side channel 122, and the guide groove, and is led out from the upper line hole 2122, so that both ends of the forming line 160 are located outside the shell 210.

[0094] One end of the tensioning wire 170 is fixed to the tensioning assembly 270, and the other end passes through the side channel 122, wraps around the occluder 110, the second slot 151, the first slot 133, and the side channel 122 and is fixed to the tensioning assembly 270, so that both ends of the tensioning wire 170 are fixed to the knob 271.

[0095] The occluder pushing mechanism 100 of the present invention utilizes a molding line 160 and a tensioning line 170 to fix the occluder 110 to the sheath 130, and controls the final shaping of the occluder 110 through the molding line 160. This connection structure replaces the existing threaded connection. When separating the occluder 110 from the conveying device, it is only necessary to cut the molding line 160 and the tensioning line 170. It has a simple structure and is easy to operate.

[0096] In an embodiment, there are four side channels 122 arranged around the side channel 122, and the tensioning line 170 and the forming line 160 each pass through two side channels 122. The tensioning line 170 and the forming line 160 are passed through the four side channels 122, so that the tensioning line 170 and the forming line 160 are independently routed, avoiding the problem of entanglement and knotting, thereby improving the convenience of the operation.

[0097] like Figure 14 and Figure 15 As shown, there are two first slots 133, and the molding line 160 and the tensioning line 170 pass through one first slot 133 respectively. There is one second slot 151, and the edge of the first slot 133 close to the second slot 151 and the edge of the second slot 151 close to the first slot 133 are both provided with cutting edges. The second slot 151 moves with the core rod 140 and radially coincides or is misaligned with the first slot 133, that is, the molding line 160 and the tensioning line 170 pass through the second slot 151 together and then extend from the two first slots 133 respectively. The provision of the cutting edge can enable the molding line 160 and the tensioning line 170 to be in a fixed state, and the core rod 140 moves backward relative to the multi-lumen tube 120, so that the second slot 151 is displaced relative to the first slot 133, and the molding line 160 and the tensioning line 170 are cut by the cutting edge.

[0098] In the embodiment, a strip guide groove 134 is axially opened at the rear end of the sheath 130, and a guide protrusion 152 is provided on the outer wall of the wire cutting tube 150. The guide protrusion 152 and the strip guide groove 134 are moved and matched so that the core rod 140 is arranged in the multi-lumen tube 120 in a rotation-proof manner. The guide protrusion 152 is matched with the strip guide groove 134 so that when the core rod 140 moves backward relative to the multi-lumen tube 120, the second slot 151 moves backward relative to the first slot 133, thereby ensuring that the cutting edge cuts the forming line 160 and the tensioning line 170 in a preset manner.

[0099] More specifically, the sheath 130 includes a cylindrical conical section 131 and a straight section 132 connected to the small diameter end of the cylindrical conical section 131. The cylindrical conical section 131 is used to accommodate the hollow hot melt tail end 115. The conical portion of the cylindrical conical section 131 is provided with a first lead hole 135 and a second lead hole 136. The molding wire 160 enters the sheath 130 through the first lead hole 135, and the tensioning wire 170 enters the sheath 130 through the second lead hole 136. The first slot 133 is opened at a position of the straight section 132 close to the cylindrical conical section 131. The first lead hole 135 and the second lead hole 136 are provided to facilitate the separation of the molding wire 160 and the tensioning wire 170 here, thereby facilitating entry into the wire cutting tube 150.

[0100] Based on the description of the specific structures of Examples 1 and 2, this embodiment further discloses a method of using the occluder delivery and molding device:

[0101] S10. Open the package, hold the thread lock and trimmer integrated handle 200, rotate the knob 271 clockwise until it reaches the rotation stop, and then rotate the operating knob 271 counterclockwise about 1 / 4 of the circumferential stroke. At this time, the tension wire 170 tightens the occluder 110 and fits tightly with the sheath 130.

[0102] S20. After the occluder 110 is surgically inserted into the relevant position in the body, that is, after the occluder 110 is released and the molding and thread trimming processes are ready to begin, the thread locking and thread trimming integrated handles 200 of the present invention are operated one by one.

[0103] It should be noted that step S20 is exactly the same as the method of the wire cutting handle and occluder delivery and molding system (application number: 2025105559797) already applied for by the applicant, and the details will not be repeated here.

[0104] S30, press the thread locking button 253 to move it downward until the limiting groove 2532 is horizontally aligned with the limiting protrusion (2551), and the torsion spring 257 resets the limiting protrusion 2551 and rotates along with the mounting ring 255 to snap into the limiting groove 2532, while the unlocking button 256 tilts outward. At this time, the thread pressing slider 252 is locked and the forming line 160 is unlocked;

[0105] S40. Pull the forming line 160 upward by hand until you feel a "click". At this time, the occluder 110 is completed. At this time, press the unlocking button 256. The unlocking button 256 rotates to drive the mounting ring 255 to rotate until the limiting protrusion 2551 disengages from the limiting groove 2532. At the same time, the wire pressing spring 254 drives the wire pressing slider 252 to move forward, and pushes the unlocking button 256 to move up and reset through the wire pressing slider 252. Under the forward pushing action of the wire pressing spring 254, the pressing portion 2523 presses against the guide groove, so that the forming line 160 is locked.

[0106] S50, buckle the anti-foolproof buckle 280, and push the trimmer push button 260 backward. The trimmer push button 260 moves backward and drives the trimmer tube 150 backward through the core rod slider 240 and the core rod 140, so that the trimmer tube 150 moves backward relative to the sheath 130, thereby causing the second slot 151 to be misaligned relative to the first slot 133. At the same time, the cutting edge is used to cut the forming line 160 and the tensioning line 170, so that the forming line 160 and the tensioning line 170 are cut into two sections, thereby disconnecting the occluder 110 from the locking and trimming integrated handle 200.

[0107] S60: After the thread trimming is completed, the locking thread trimmer integrated handle 200 is held and withdrawn from the human body. Thus, the use of the instrument is completed.

[0108] The invention provides a locking and cutting integrated handle and occluder delivery and molding device with the following technical effects:

[0109] 1. Adopting an integrated structure with integrated locking, shaping and cutting functions, and pre-assembling the occluder and delivery system into one, it reduces clinical operation steps; through functional integrated design, it optimizes the operation process, reduces the complexity of operation, and thus improves the efficiency and safety of surgery.

[0110] 2. The thread locking, shaping, and trimming functions are configured into an integrated handle, which can simultaneously complete the tensioning wire pre-tightening, shaping wire shaping, and tensioning / forming wire trimming operations, allowing the surgeon to complete the handle operation alone. This structure effectively shortens the operation time, reduces the radiation exposure of the surgeon and patient, and improves the accuracy of the operation.

[0111] 3. The integrated handle is equipped with different buttons, push buttons, knobs and anti-foolproof structures, which make it convenient for doctors to directly identify functions and avoid surgical problems caused by misoperation.

[0112] The technical solution of the present invention has been described in detail above with reference to specific embodiments. The specific embodiments described are intended to help understand the concept of the present invention. Derivations and modifications made by those skilled in the art based on the specific embodiments of the present invention also fall within the scope of protection of the present invention.

Claims

1. A thread locking and thread trimming integrated handle (200), characterized in that: include: The shell (210) is provided with a front end hole (2111), a side sliding hole (2123), an upper wall hole (2121), an upper wire hole (2122) and a rear end hole (2124), wherein the upper wire hole (2122) is used for the molding wire (160) to enter and exit the shell (210), and the shell (210) is fixed with a multi-lumen tube fixing ring and a wire guide (230) in sequence from front to back, and the center hole of the multi-lumen tube fixing ring and the front part of the wire guide hole (231) of the wire guide are both aligned with the front end hole ( 2111) are coaxially arranged, the multi-lumen tube fixing ring is used to fix the multi-lumen tube extending from the front end hole (2111) into the housing (210), the housing (210) is provided with a core rod slider (240) located behind the guide wire device (230) in a manner that can move along the central axial direction of the front end hole (2111), and the core rod slider (240) is used to connect the core rod (140) inserted into the housing (210) through the front end hole (2111), the central hole of the multi-lumen tube fixing ring, and the guide wire hole (231) of the guide wire device; A wire locking assembly (250), the wire locking assembly (250) passing through the upper wall hole (2121), and used for clamping and releasing the molding wire (160) guided through the wire guide hole (231) of the wire guide; A tensioning assembly, the tensioning assembly passing through the rear end hole (2124) and used for tightening and loosening the tensioning line (170); and a thread trimming push button (260), which slides through the side sliding hole (2123) and is connected to the mandrel slider (240), and is used to drive the mandrel slider (240) to move forward and backward relative to the multi-lumen tube (120).

2. A thread locking and trimming integrated handle (200) according to claim 1, characterized in that: The rear end of the guide hole (231) of the guide device has a guide groove inclined upward, and the rear side of the guide groove is an open end. The molding wire (160) passes through the guide groove and is led out from the upper wire hole (2122).

3. The thread locking and trimming integrated handle (200) according to claim 2, characterized in that: The locking wire assembly (250) includes: A fixing seat (251), the fixing seat (251) is fixedly arranged at the upper portion of the housing (210), a strip groove (2511) is provided on the upper portion of the fixing seat (251), and a stop platform (2512) is provided at the rear end of the strip groove (2511); A wire pressing slider (252), the wire pressing slider (252) is slidably arranged in the strip groove (2511), a first through hole (2521) is vertically opened in the middle of the wire pressing slider (252), and the rear inner wall of the first through hole (2521) is a first inclined surface (2522); A thread locking button (253), wherein the thread locking button (253) has a second inclined surface (2531) that slides with the first inclined surface (2522); and a wire pressing spring (254), wherein the front end of the wire pressing spring (254) abuts against the rear end of the wire pressing slider (252), and the rear end of the wire pressing spring (254) abuts against the inside of the housing (210); When the wire locking assembly (250) is in the wire locking state, the wire pressing slider (252) is pushed forward by the wire pressing spring (254), and the front end of the wire pressing slider (252) is pressed into the guide groove, clamping the molding wire (160) there; when the wire locking assembly (250) is in the non-wire locking state, the wire locking button (253) moves downward to push the wire pressing slider (252) backward, and the front end of the wire pressing slider (252) is separated from the guide groove, so that the molding wire (160) is loosened, and the wire pressing spring (254) is in a strongly compressed state.

4. The thread locking and trimming integrated handle (200) according to claim 3, characterized in that: The left and right side walls of the guide groove are provided with guide grooves (232) for the front portion of the wire pressing slider (252) to slide forward and backward.

5. The thread locking and trimming integrated handle (200) according to claim 4, characterized in that: The locking wire assembly (250) further comprises a mounting ring (255), an unlocking button (256) and a torsion spring (257). The mounting ring (255) is rotatably arranged below the front portion of the fixing seat (251). A limiting protrusion (2551) is radially fixed on the outer peripheral wall of the mounting ring (255). The unlocking button (256) movably passes through the housing (210) and is fixedly connected to the mounting ring (255). The torsion spring (257) is sleeved on the mounting ring (255), and one end of the torsion spring (257) is clamped on the mounting ring (255) and the other end is clamped in the housing (210). The fixing seat (251) is provided with an avoidance hole (2513) for the locking wire button (253) to move downward. A limiting groove (2532) cooperating with the limiting protrusion (2551) is provided at the middle of the front end of the locking wire button (253). Wherein, when the wire locking assembly (250) is in the wire locking state, the limiting protrusion (2551) abuts against the side wall of the wire locking button (253), and the wire pressing slider (252) is pushed forward by the wire pressing spring (254), and the front end of the wire pressing slider (252) is pressed against the guide groove; when the wire locking assembly (250) is in the non-wire locking state, the front end of the wire pressing slider (252) is separated from the guide groove, and the limiting protrusion (2551) is stuck in the limiting groove (2532) to limit the forward movement of the wire pressing slider (252), and the forming line (160) is released.

6. The thread locking and trimming integrated handle (200) according to claim 5, characterized in that: The limiting protrusion (2551) is a fan-shaped structure.

7. The thread locking and trimming integrated handle (200) according to claim 6, characterized in that: The tensioning assembly comprises a knob (271) and a wire post (272). The knob (271) rotates in a damped manner to pass through the rear end hole (2124). The wire post (272) is fixed in the housing (210). Both ends of the tensioning wire (170) pass around the wire post (272) and are fixed to the side wall of the knob (271).

8. The thread locking and trimming integrated handle (200) according to claim 7, characterized in that: A plurality of radially extending connecting protrusions (2713) are evenly distributed on the outer peripheral wall of the front portion of the knob (271), and both ends of the tensioning wire (170) pass around the wire post (272) and are connected to the plurality of connecting protrusions (2713).

9. The thread locking and trimming integrated handle (200) according to claim 8, characterized in that: It also includes an anti-fouling buckle (280), the housing (210) and the thread trimming push button (260) are both provided with a fixing groove, and the anti-fouling buckle (280) is provided with a fixing protrusion (281) that is buckled and connected with each fixing groove.

10. An occluder delivery and molding device, comprising a thread locking and thread cutting integrated handle (200) according to any one of claims 1 to 9, characterized in that: It also includes an occluder pushing mechanism (100), which includes: An occluder (110), the occluder (110) comprising a shaped knot (1131); A multi-lumen tube (120), the multi-lumen tube (120) having a central channel (121) and at least one side channel (122) concentric with the central channel (121); a sheath (130) is fixedly sheathed at the front end of the central channel (121); a first slot (133) is provided on the side wall of the sheath (130); and a rear end of the multi-lumen tube (120) is fixedly sheathed in a multi-lumen tube fixing ring; A mandrel (140) is provided with a central passage (121) in a manner that allows the mandrel (140) to move forward and backward and prevent rotation. A wire cutting tube (150) located in a sheath (130) is fixedly provided at the front end of the mandrel (140). A second slot (151) is provided at the front end of the wire cutting tube (150). The rear end of the mandrel (140) is fixedly provided in the central hole of the mandrel slider (240). A forming line (160), one end of which enters from the upper line hole (2122), passes through the guide groove, the side channel (122), the forming knot (1131), the second slot hole (151), the first slot hole (133), the side channel (122) and the guide groove, and then exits from the upper line hole (2122); and a tensioning wire (170), one end of the tensioning wire (170) being fixed to the tensioning assembly, and the other end of the tensioning wire (170) passing through the side channel (122), winding around the occluder (110), the second slot (151), the first slot (133), and the side channel (122), and then being fixed to the tensioning assembly; At least one edge of the first slot hole (133) and the second slot hole (151) is provided with a cutting edge, and the core rod (140) can be moved axially along the central channel (121) relative to the multi-lumen tube (120) to cause the second slot hole (151) to be misaligned with the first slot hole (133), thereby cutting the forming line (160) and the tensioning line (170) through the cutting edge.

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