Occluder pushing mechanism

Abstract

The utility model discloses a kind of pusher mechanisms of occluder, including occluder, multi-cavity pipe, core rod, forming stay wire and tight line, occluder includes forming knot;Multi-cavity pipe has central passage and side passage, the proximal end of central passage is fixedly sleeved with sheath, sheath is equipped with first slot hole;Core rod is with the way of movable and rotation-stopping and is arranged central passage, the proximal end of this core rod is fixedly equipped with the cutting line tube in sheath, the proximal end of cutting line tube is equipped with second slot hole;First slot hole and second slot hole at least one edge portion are equipped with blade edge, core rod moves along central passage axial relative to multi-cavity pipe can make second slot hole and first slot hole dislocation, and then cut off forming stay wire and tight line by blade edge.The utility model's pusher mechanism of occluder, occluder, multi-cavity pipe and core rod are achieved mechanical interlocking fixed by forming stay wire and tight line, replace traditional thread coupling mode, eliminate the precision alignment and multi-step assembly process required by thread screwing, significantly improve the deployment efficiency of interventional instrument.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a occluder pushing mechanism. Background Technology

[0002] Patent foramen ovale (PFO) is a congenital heart defect, and currently, transcatheter occlusion devices are commonly used for treatment. There are two traditional types of PFO occluders: metallic occluders and biodegradable occluders. Metallic occluders, due to the self-expanding properties of nickel-titanium alloys, automatically shape after release from the delivery sheath, and can be released simply by loosening the mandrel. However, the future trend is likely towards biodegradable occluders, which typically have more complex delivery systems. Biodegradable occluders, because of their inelastic material, require a shaping step during the occlusion procedure, secured to the end with a suture for complete closure. Currently, the existing method involves the clinician connecting the occluder and delivery system via threads before surgery, requiring the clinician to connect the suture and handle; and after the occlusion procedure, the operator must cut one suture with scissors and then pull the remaining suture out of the body – a tedious process requiring greater care.

[0003] The shortcomings of existing catheter delivery occlusion devices in use:

[0004] 1. Traditional metal patent foramen ovale occluders consist of a nickel-titanium alloy skeleton and a polyester fiber flow-blocking membrane, employing a dual-disc design. They utilize the self-expanding properties of the nickel-titanium alloy to clamp the foramen ovale, achieving occlusion. However, because metal stents are non-degradable, their long-term presence in the heart poses several potential risks. For example, nickel-titanium ions may leach out, affecting human health; and during MRI scans, the metal material may generate heat, posing a threat to patient safety.

[0005] 2. While existing biodegradable patent foramen ovale occluders have made breakthroughs in material biodegradability, significant drawbacks remain. To facilitate real-time observation of the occluder's position via DSA angiography, most commercially available biodegradable occluders incorporate a platinum-iridium contrast ring. However, this contrast ring is non-biodegradable, and its long-term retention within the heart poses unknown risks, limiting the clinical effectiveness of biodegradable occluders.

[0006] 3. In terms of operation, existing biodegradable patent foramen ovale occluder systems are significantly complex. During surgery, the occluder and delivery system need to be temporarily assembled, with the suture-cutting step after the occluder is released being particularly cumbersome. Furthermore, the tail end of the occluder is threaded to the head end of the delivery system's mandrel, requiring clinicians to specifically learn the operating techniques. This not only prolongs the clinicians' learning period but also limits the product's scope of application and increases its manufacturing costs. Utility Model Content

[0007] In view of this, the present invention proposes a blocking device pushing mechanism to solve at least one of the above-mentioned technical problems.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A occluder pushing mechanism, comprising:

[0010] The occluder includes a shaped knot;

[0011] A multi-lumen tube having a central channel and at least one side channel concentric with the central channel, the proximal end of the central channel being fixedly fitted with a sheath, and the side wall of the sheath having a first slot.

[0012] A core rod, wherein the core rod is inserted through a central channel in a manner that allows it to move back and forth and prevents rotation, and a wire-cutting tube located inside a sheath is fixed at the proximal end of the core rod, and a second slot is provided at the proximal end of the wire-cutting tube.

[0013] A forming wire, one end of which enters from the far end of the side channel, passes through the side channel, through the forming knot, the second slot, the first slot, and the near end of the side channel in sequence, and then extends out from the far end of the side channel.

[0014] And a tension line, one end of which enters from the far end of the side channel, passes sequentially through the side channel, the winding sealer, the second slot, the first slot, and the near end of the side channel, and then extends out from the far end of the side channel;

[0015] The first slot and the second slot have a cutting edge at least on one edge. The mandrel moves axially relative to the multi-cavity tube along the central channel, which can cause the second slot to be misaligned with the first slot, thereby cutting the forming wire and tension wire through the cutting edge.

[0016] To better implement the above technical solution, optionally, the edge channels are four arranged around the edge channels, and the forming wire and tensioning wire each pass through two edge channels.

[0017] Optionally, there are two first slots, with the forming wire and tensioning wire each passing through one first slot, and one second slot. Both the edge of the first slot near the edge of the second slot and the edge of the second slot near the edge of the first slot are provided with cutting edges.

[0018] Optionally, the second slot moves with the mandrel and radially coincides with or is misaligned with the first slot.

[0019] Optionally, the distal end of the sheath is provided with a strip-shaped guide groove, and the outer wall of the wire-cutting tube is provided with a guide protrusion. The guide protrusion and the strip-shaped guide groove move together to make the mandrel positioned in the multi-cavity tube at this point in a non-rotating manner.

[0020] Optionally, the plugger includes a left umbrella disc, a right umbrella disc, a forming knot, and a hollow waist connecting the left and right umbrella discs. The right umbrella disc has a hollow hot-melt tail end that communicates with the hollow waist at the center of one end away from the left umbrella disc. One end of the forming knot is fixed on the left umbrella disc, and the other end is wrapped around the left umbrella disc, passes through the hollow waist, and forms a forming knot inside the hollow hot-melt tail end. After the forming knot is pulled out from the hollow waist, it automatically expands and plugs the hollow hot-melt tail end or plugs the lower end of the hollow hot-melt tail end. Both the left and right umbrella discs have built-in flow-blocking membranes.

[0021] The left umbrella disc, waist section, right umbrella disc, hollow hot-melt tail end, and forming junction line are all made of PDO material, while the flow-blocking membrane is made of PLCL material.

[0022] Optionally, the sheath includes a cylindrical conical section and a straight section connected to the small-diameter end of the cylindrical conical section. The cylindrical conical section is used to accommodate the hollow hot-melt tail end. The conical part of the cylindrical conical section is provided with a first lead hole and a second lead hole. The forming pull wire enters the sheath through the first lead hole, and the tension wire enters the sheath through the second lead hole. The first slot is opened at the part of the straight section near the cylindrical conical section.

[0023] Optionally, the outer wall of the tail end of the multi-lumen tube is provided with a first MARK point marking ring, a second MARK point marking ring, and a third MARK point marking ring. The first MARK point marking ring, the second MARK point marking ring, and the third MARK point marking ring are used in conjunction with ultrasound to determine the position of the occluder in real time.

[0024] The beneficial effects of this utility model are:

[0025] The plugging device pushing mechanism of this utility model has the following technical effects:

[0026] 1. The plugging device uses two biodegradable materials, PDO and PLCL. It will degrade into water and carbon dioxide and be excreted from the body within two years after the plugging is completed, and is harmless to the human body.

[0027] 2. During interventional procedures, clinicians can determine the position of the occluder within the delivery sheath by observing the position of the MARK point marker ring. This avoids the need for DSA angiography and eliminates the need for an additional platinum-iridium contrast ring on the occluder, further improving the safety and minimizing trauma of the procedure.

[0028] 3. The occluder adopts a two-stage adjustment method, which makes it convenient for clinicians to adjust it during surgery to achieve the best occlusion effect for the patient.

[0029] 4. The occluder, multi-lumen tube, and mandrel are mechanically interlocked and fixed via forming and tensioning wires, replacing the traditional threaded coupling method. This eliminates the precise alignment and multi-step assembly process required for threaded connections, significantly improving the deployment efficiency of interventional devices. It also avoids the risk of micron-sized debris detachment caused by friction between metal threads, reducing the potential complications of intravascular foreign body embolism. Furthermore, the use of biocompatible polymer wires to construct the mechanical conduction path avoids ion precipitation problems caused by metal interface contact, further optimizing the safety of the device. Attached Figure Description

[0030] Figure 1 This is a front view of a sealing device conveying and forming apparatus according to Embodiment 1 of this utility model;

[0031] Figure 2 yes Figure 1 Front view of the push mechanism of the central plugging device;

[0032] Figure 3 yes Figure 2 A three-dimensional schematic diagram of the central plugging device;

[0033] Figure 4 yes Figure 3 A schematic diagram of the intermediate plugging device from its initial structure to the first-stage plugging form;

[0034] Figure 5 yes Figure 3 A schematic diagram of the intermediate plugging device from its initial structure to its second-stage plugging configuration;

[0035] Figure 6 yes Figure 2 Exploded view;

[0036] Figure 7 yes Figure 6 A three-dimensional schematic diagram of the middle section structure from the first angle;

[0037] Figure 8 yes Figure 6 A three-dimensional schematic diagram of the middle section structure from the second angle;

[0038] Figure 9 yes Figure 1 Front view of the shearing device;

[0039] Figure 10 yes Figure 9 Exploded view;

[0040] Figure 11 yes Figure 10 A schematic diagram of the upper and middle locking wire assembly;

[0041] Figure 12 yes Figure 10 A schematic diagram of the shear line assembly in its normal operating state;

[0042] Figure 13 yes Figure 10 A schematic diagram of the shear line assembly in the pressed state;

[0043] Figure 14 This is a schematic diagram of the combination and explosion of a sealing device conveying and forming apparatus, a loader, and a conveying sheath;

[0044] Figure 15 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (I).

[0045] Figure 16 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (II).

[0046] Figure 17 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (Part 3).

[0047] Figure 18 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (Part 4).

[0048] Figure 19 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (V).

[0049] Figure 20 This is a schematic diagram of the surgical procedure involving the occluder delivery and shaping device, delivery sheath, and loader (VI).

[0050] Figure 21 This is a schematic diagram of the fit between the sheath and the wire cutting tube (the sheath and the wire cutting tube overlap radially, and the forming pull wire and the tension wire are both made of one wire).

[0051] Figure 22 This is a schematic diagram of the cooperation between the sheath and the wire cutting tube (the sheath and the wire cutting tube are radially misaligned to cut and form the wire and tension wire).

[0052] Figure label:

[0053] The plugging device push mechanism 100, the plugging device 110, the left umbrella plate 111, the right umbrella plate 112, the forming knot line 113, the forming knot 1131, the hollow waist 114, the hollow hot melt tail end 115, and the flow-blocking membrane 116.

[0054] Multi-cavity tube 120, central channel 121, side channel 122, first MARK mark ring 123, second MARK mark ring 124, third MARK mark ring 125, sheath 130, cylindrical conical section 131, straight section 132, first slot 133, strip guide groove 134, first lead wire hole 135, second lead wire hole 136, mandrel 140, small diameter section 141, wire cutting tube 150, second slot 151, guide protrusion 152, forming pull wire 160, tension wire 170;

[0055] Wire cutting handle 200, outer shell 210, front end cover 211, front end hole 2111, rear end cover 212, upper outer shell 213, upper wall hole 2131, upper wire hole 2132, lower outer shell 214, lower wall hole 2141, lower wire hole 2142, anti-rotation clip 2143, fixing clip 2144, side wall hole 215;

[0056] Multi-cavity tube fixing ring 220, annular body 221, locking protrusion 222, locking groove 223, lead wire 230, wire inlet hole 231, first wire hole 232, second wire hole 233, first guide groove 234, convex ring 234, core rod slider 240, slider 241, first connecting part 242, locking assembly 250, fixing seat 251, strip groove 2511, stop boss 2512, clamping plate guide rail 2513, locking slider 252, first through hole 2521, first inclined surface 2522, guide part 2523, locking button 253, second inclined surface 2531, locking spring 254, wire cutting push button 255, push-pull part 2551, moving part 2552, second connecting part 2553, pressing spring 256;

[0057] Delivery sheath 300;

[0058] Loader 400. Detailed Implementation

[0059] The technical solution of this utility model will be described in detail below with reference to the accompanying drawings and specific embodiments. Identical components are indicated by the same reference numerals.

[0060] Example 1

[0061] like Figure 1 As shown, a plugging device for conveying and forming includes a plugging device pushing mechanism 100 and a wire cutting handle 200.

[0062] like Figure 2 As shown, the plugging device pushing mechanism 100 includes a plugging device 110, a multi-chamber tube 120, a mandrel 140, a forming pull wire 160, and a tension wire 170.

[0063] like Figures 3-5As shown, the plugging device 110 includes a shaped knot 1131. Specifically, the plugging device 110 includes a left umbrella disc 111, a right umbrella disc 112, a shaped knot line 113, and a hollow waist section 114 connecting the left umbrella disc 111 and the right umbrella disc 112. The right umbrella disc 112 has a hollow hot-melt tail end 115 at the center of one end away from the left umbrella disc 111, which communicates with the hollow waist section 114. One end of the shaped knot line 113 is fixed inside the left umbrella disc 111, and the other end is wound around the left umbrella disc 111, passes through the hollow waist section 114, and forms a shaped knot 1131 inside the hollow hot-melt tail end 115. After the shaped knot 1131 is pulled out from the hollow waist section 114, it automatically expands and plugs the hollow hot-melt tail end 115 or the lower end of the hollow hot-melt tail end 115. Both the left umbrella disc 111 and the right umbrella disc 112 have built-in flow-blocking membranes 116.

[0064] In the embodiment of the utility model, the left umbrella disc 111, waist 114, right umbrella disc 112, hollow hot-melt tail end 115, and forming knot 113 are all made of PDO material. The left umbrella disc 111, waist 114, and right umbrella disc 112 are all woven by a braiding machine and then shaped by placing them in a drying oven at a certain temperature using a shaping fixture. 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. The two flow-blocking membranes 116 are sewn into the left umbrella disc 111 and right umbrella disc 112 of the plugger 110 using biodegradable PDO material.

[0065] In an embodiment of the utility model, the diameter of the central hole of the hollow hot-melt tail end 115 is larger than the diameter of the central hole of the right umbrella disc 112. The central hole of the right umbrella disc 112 is used to pass through the shaped knot wire 113. The sealing device 110 has a two-stage adjustment method, such as... Figure 4 As shown, the molded structure 1131 is placed in the central hole of the hollow hot-melt tail end 115, forming the first-stage adjustment; as Figure 5 As shown, the molding knot 1131 is placed outside the central hole of the hollow thermofused tail end 115 to form a second-level adjustment. The second-level adjustment is suitable for patients with normal heart thickness, while the first-level adjustment is suitable for patients with hypertrophic foramen ovale. Using the first-level adjustment method can avoid forcibly tightening the molding knot 1131 for patients with hypertrophic foramen ovale, which would cause the molding knot 1131 to slip off. This further avoids the waste of the occluder 110 caused by the replacement of the occluder 110 due to the slippage of the molding knot 1131 during clinical surgery.

[0066] In this embodiment of the invention, the occluder 110 is formed as follows: When the occluder 110 enters the heart, and the left and right parapets 111 and 112 are respectively in the left and right atria of the heart, the shape of the occluder 110 has reached the desired state. However, since the material of the occluder 110 does not have the self-shaping properties of metal, it is necessary to pull the forming wire 160 to move the forming knot 1131 downwards. When the forming knot 1131 reaches the hollow heat-fused tail end 115, due to the increased expansion of the forming knot 1131, it gets stuck in the hollow heat-fused tail end 115, forming a primary occlusion (e.g., ...). Figure 4 As shown), continue pulling down the forming knot 1131. The forming knot 1131 is stuck outside the hollow hot melt tail end 115, forming a secondary seal (as shown). Figure 5 As shown in the figure, the plug 110 is finally formed.

[0067] like Figure 6-8 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 proximal end of the central channel 121 is fixedly fitted with a sheath 130, and the side wall of the sheath 130 is provided with a first slot 133.

[0068] In the embodiments of this utility model, it should be noted that: the proximal end refers to the end of the same component that is relatively close to the heart, and the distal end refers to the end of the same component that is relatively far away from the heart.

[0069] The core rod 140 is inserted through the central channel 121 in a manner that allows it to move back and forth and prevents rotation. The proximal end of the core rod 140 is fixed with a wire cutter tube 150 located inside the sheath 130. The proximal end of the wire cutter tube 150 is provided with a second slot 151. The distal end of the core rod 140 is fixed in the central hole of the core rod slider 240.

[0070] Specifically, both the wire cutter tube 150 and the core rod 140 are made of stainless steel. The near end of the core rod 140 has a small diameter portion 141. The far end of the wire cutter tube 150 is fitted onto the small diameter portion 141 of the core rod 140 and fixed by laser welding, so that the wire cutter tube 150 and the core rod 140 form an integral structure.

[0071] One end of the forming wire 160 enters from the upper wire hole 2132, passes through the first wire hole 232, the side channel 122, through the forming knot 1131, the second slot 151, the first slot 133, the side channel 122, and the first wire hole 232, and then exits from the upper wire hole 2132;

[0072] Tensioning wire 170, one end of tensioning wire 170 enters from lower wire hole 2142, passes through second wire hole 233, side channel 122, winding sealer 110, second slot hole 151, first slot hole 133, side channel 122, and second wire hole 233, and then exits from lower wire hole 2142;

[0073] The plugging device pushing mechanism 100 of this utility model uses a forming pull wire 160 and a tension wire 170 to fix the plugging device 110 to the sheath 130. At the same time, the forming pull wire 160 controls the final shaping of the plugging device 110. This connection structure replaces the existing threaded connection. When separating the plugging device 110 from the conveying device, it is only necessary to cut the forming pull wire 160 and the tension wire 170. Its structure is simple and the operation is convenient.

[0074] In an embodiment of this utility model, there are four side channels 122 arranged around the side channels 122. The tension line 170 and the shaping line 160 each pass through two side channels 122. By using the four side channels 122 to run the tension line 170 and the shaping line 160, the tension line 170 and the shaping line 160 can run independently, avoiding the problem of tangling and knotting, thereby improving the convenience of the operation.

[0075] like Figure 6 As shown, the outer wall of the tail of the multi-lumen tube 120 is provided with a first MARK point marking ring 123, a second MARK point marking ring 124, and a third MARK point marking ring 125. The first MARK point marking ring 123, the second MARK point marking ring 124, and the third MARK point marking ring 125, together with ultrasound, are used to determine the position of the occluder 110 in real time. Specifically, the first MARK point marking ring 123 is used to determine that the left parasol 111 is flush with the proximal end of the delivery sheath 300 (the specific function of which will be explained later), the second MARK point marking ring 124 is used to determine that the left parasol 111 is completely exposed in the left atrium of the heart, and the third MARK point marking ring 125 is used to determine that the occluder is completely in the occlusion state.

[0076] like Figure 7 and Figure 8 As shown, there are two first slots 133, through which the forming wire 160 and the tension wire 170 pass respectively. There is one second slot 151. Both the edge of the first slot 133 near the edge of the second slot 151 and the edge of the second slot 151 near the edge of the first slot 133 are provided with cutting edges. The second slot 151 moves with the mandrel 140 and radially coincides with or is misaligned with the first slot 133. That is, the forming wire 160 and the tension wire 170 pass through the second slot 151 together and then extend out from the two first slots 133 respectively. The cutting edges allow the forming wire 160 and the tension wire 170 to be cut by the cutting edges during the process of the mandrel 140 moving backward relative to the multi-cavity tube 120 while the forming wire 160 and the tension wire 170 are in a fixed state and the second slot 151 is displaced relative to the first slot 133.

[0077] In an embodiment of this utility model, a strip-shaped guide groove 134 is axially provided at the distal 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-shaped guide groove 134 move in cooperation so that the mandrel 140 is positioned in the multi-cavity tube 120 in a non-rotating manner. By using the cooperation between the guide protrusion 152 and the strip-shaped guide groove 134, when the mandrel 140 moves backward relative to the multi-cavity tube 120, the second slot 151 moves backward relative to the first slot 133, thereby ensuring that the cutting edge cuts the forming wire 160 and the tension wire 170 in a preset manner.

[0078] 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 part of the cylindrical conical section 131 is provided with a first lead hole 135 and a second lead hole 136. The forming pull wire 160 enters the sheath 130 through the first lead hole 135, and the tension wire 170 enters the sheath 130 through the second lead hole 136. The first slot 133 is opened at the part of the straight section 132 near the cylindrical conical section 131. The first lead hole 135 and the second lead hole 136 are provided to facilitate the separation of the forming pull wire 160 and the tension wire 170 at this point, thereby facilitating their entry into the shear tube 150.

[0079] like Figures 9 to 13 As shown, the wire cutting handle 200 includes a housing 210, a multi-cavity tube retaining ring 220, a wire guide 230, a core rod slider 240, a wire locking assembly 250, and a wire cutting assembly.

[0080] like Figure 10 As shown, the outer casing 210 has a front end hole 2111, a side wall hole 215, an upper wall hole 2131, a lower wall hole 2141, an upper wire hole 2132, and a lower wire hole 2142 that communicate with the inner cavity of the outer casing 210.

[0081] Among them, the front end hole 2111 is used to pass through the multi-cavity tube 120 and the core rod 140 inside the multi-cavity tube 120; the side wall hole 215 is used to pass through the wire cutting assembly; the upper wall hole 2131 and the lower wall hole 2141 are used to pass through the wire locking assembly 250; the upper wire hole 2132 is used for the forming pull wire 160 to enter and exit the outer shell 210; and the lower wire hole 2142 is used for the tension wire 170 to enter and exit the outer shell 210.

[0082] In the embodiments of this utility model, in order to facilitate the assembly of the components inside the outer shell 210, the outer shell 210 is assembled from a front cover 211, a rear cover 212, an upper outer shell 213 and a lower outer shell 214. The outer shell 210 is a common structure that meets the assembly requirements, and the specific structure will not be described in detail.

[0083] The multi-lumen tube retaining ring 220 is coaxial with the front end hole 2111 and fixed in the front part of the inner cavity of the outer shell 210, and is used to connect with the end of the multi-lumen tube 120 that extends into the inner cavity of the outer shell 210 from the front end hole 2111.

[0084] like Figure 10 As shown, the multi-lumen tube fixing ring 220 includes an annular body 221 and two locking protrusions 222 symmetrically fixed to the outer wall of the middle part of the annular body 221 along the central axis of the annular body 221. The two locking protrusions 222 form a locking groove 223 between them. The inner cavity of the outer shell 210 is provided with a first mounting groove for defining the multi-lumen tube fixing ring 220 and an anti-rotation locking strip 2143 that is locked into the locking groove 223. The central hole of the annular body 221 is used to fix the end of the multi-lumen tube 120 that extends into the inner cavity of the outer shell 210 from the front end hole 2111.

[0085] Specifically, the first mounting groove includes an upper half disposed inside the upper housing 213 and a lower half disposed inside the lower housing 214. The upper half and the lower half together define the multi-cavity tube fixing ring 220, while the anti-rotation clip 2143 that is inserted into the locking groove 223 fixes the multi-cavity tube fixing ring 220.

[0086] like Figure 10 As shown, the lead wire 230 is fixed in the inner cavity of the housing 210 and located behind the multi-cavity tube fixing ring 220. The lead wire 230 includes an inlet hole 231, a first wire hole 232 and a second wire hole 233. The inlet hole 231 is coaxial with the front end hole 2111, and the inlet hole 231, the first wire hole 232 and the second wire hole 233 form a herringbone structure.

[0087] Specifically, at least one protruding ring 234 is fixedly provided on the upper and lower sides of the front end of the lead wire 230, and the inner cavity of the housing 210 is provided with a second mounting groove for placing the lead wire 230 and a fixing strip 2144 for engaging each protruding ring 234.

[0088] In an embodiment of this utility model, two protruding rings 234 are fixedly provided at intervals on the upper and lower sides of the front end of the lead wire 230. The upper outer shell 213 and the lower outer shell 214 are fixed with fixing strips 2144 that correspond one-to-one with the protruding rings 234. The lead wire 230 is stably fixed in the outer shell 210 by the cooperation of the fixing strips 2144 and the protruding rings 234.

[0089] The mandrel slider 240 is disposed in the inner cavity of the housing 210 and located behind the lead wire 230 in a manner that allows it to move back and forth along the center of the front end hole 2111. It is used to fix the mandrel 140 that extends into the inner cavity of the housing 210 from the front end hole 2111.

[0090] The locking wire assembly 250 includes an upper locking wire assembly and a lower locking wire assembly. The upper locking wire assembly passes through the upper wall hole 2131 and is used to lock and unlock the shaped pull wire 160 passing through the first wire hole 232. The lower locking wire assembly passes through the lower wall hole 2141 and is used to lock and unlock the tension wire 170 passing through the second wire hole 233.

[0091] The wire-cutting assembly slides through the side wall hole 215 and is connected to the mandrel slider 240, which is used to drive the mandrel slider 240 to move back and forth relative to the multi-cavity tube 120.

[0092] When using the wire-cutting handle 200 of this utility model embodiment, the rear of the forming pull wire 160 and tension wire 170 are locked based on the wire-locking assembly 250. The wire-cutting assembly moves backward, causing the core rod 140 and the cutting tube 150 to move backward relative to the multi-cavity tube 120, so that the cutting tube 150 is displaced backward relative to the sheath 130. At the same time, the first slot 133 and the second slot 151 are misaligned. The forming pull wire 160 and tension wire 170 are cut by the cutting edge. Then, the wire-locking assembly 250 is pressed to unlock the forming pull wire 160 and tension wire 170. At this time, the broken forming pull wire 160 and tension wire 170 can be slowly pulled out from the outer shell 210.

[0093] like Figure 10 and Figure 11 As shown, the wire locking assembly includes: a fixing base 251, a wire locking slider 252, a wire locking button 253, and a wire locking spring 254.

[0094] The upper part of the fixed base 251 is provided with a strip groove 2511, and the rear end of the strip groove 2511 is provided with a stop boss 2512. The locking slider 252 is slidably disposed in the strip groove 2511. The middle part of the locking slider 252 is provided with a first through hole 2521 in the vertical direction. The inner wall of the rear side of the first through hole 2521 is a first inclined surface 2522. The locking button 253 has a second inclined surface 2531 that slides with the first inclined surface 2522. The front end of the locking spring 254 abuts against the rear end of the locking slider 252, and the rear end abuts against the inner cavity of the outer shell 210.

[0095] Under normal conditions, the locking slider 252, pushed by the locking spring 254, has its front end abutting against the inner wall of the first wire hole 232, clamping the forming pull wire 160 there. When it is necessary to pull the wire, the locking button 253 is pressed down, and the locking button 253 moves downward and drives the locking slider 252 to move backward until it abuts against the stop boss 2512. At this time, the locking spring 254 is compressed, and the front end of the locking slider 252 disengages from the inner wall of the first wire hole 232, thus unlocking the forming pull wire 160 and the tension wire 170. The design of two locking sliders 252 allows the rear of the forming pull wire 160 and the tension wire 170 to be fixed under normal conditions.

[0096] Specifically, the rear sides of both the first wire hole 232 and the second wire hole 233 are open structures. The left and right sidewalls of the first wire hole 232 are provided with first guide grooves 234 for the front part of the wire locking slider 252 of the upper wire locking assembly to slide back and forth. The left and right sidewalls of the second wire hole 233 are provided with first guide grooves 234 for the front part of the wire locking slider of the lower wire locking assembly to slide back and forth. The front part of the upper wire locking assembly and the wire locking slider 252 of the upper wire locking assembly are provided with guide portions 2523 that cooperate with the corresponding first guide grooves 234. The width of the guide portions 2523 is smaller than the width of the wire locking slider 252. Increasing the guide portions 2523 and the first guide grooves 234 can control the accuracy of the upper wire locking assembly and the lower wire locking assembly, thereby improving the reliability of the wire locking assembly in clamping and fixing the forming pull wire 160 and the tension wire 170.

[0097] like Figure 10 As shown, sliders 241 are symmetrically fixed at the upper and lower ends of the mandrel slider 240. The lower end of the upper locking assembly fixing seat 251 is provided with a clamping guide rail 2513 that slides with damping with the upper slider 241 of the mandrel slider 240. The lower end of the lower locking assembly fixing seat 251 is provided with a clamping guide rail 2513 that slides with damping with the lower slider 241 of the mandrel slider 240. Setting the clamping guide rail 2513 on the fixing seat 251 can make the overall structure more reasonable and reliable.

[0098] like Figures 12 to 13 As shown, the wire cutting assembly includes a wire cutting push button 255, a pressing spring 256, and a first connecting part 242. The first connecting part 242 is fixed to the side wall of the corresponding side wall hole 215 of the mandrel slider 240. The side wall hole 215 has a strip-shaped structure along the front and rear direction of the outer shell 210. The wire cutting push button 255 includes a push-pull part 2551 located outside the outer shell 210, a moving part 2552 that slides with the side wall hole 215, and a second connecting part 2553 located inside the outer shell 210. The push-pull part 2551, the moving part 2552, and the second connecting part 2553 are integrally connected. One end of the pressing spring 256 abuts against the first connecting part 242, and the other end abuts against the second connecting part 2553.

[0099] Under normal conditions, the pressing spring 256 is in its natural state, and the portion of the moving part 2552 near the second connecting part 2553 engages with the inner wall of the side wall hole 215. The middle section of the pressing spring 256 is exposed between the first connecting part 242 and the second connecting part 2553, and the wire-cutting push button 255 is locked in the front-back direction of the side wall hole 215. When cutting the wire, pressing the wire-cutting push button 255 compresses the pressing spring 256, and the portion of the moving part 2552 near the push-pull part 2551 engages with the inner wall of the side wall hole 215. The middle section of the pressing spring 256 is compressed into the first connecting part 242 and the second connecting part 2553, and the wire-cutting push button 255 is unlocked in the front-back direction of the side wall hole 215. Using the above-described wire-cutting assembly can prevent clinicians from accidentally pushing or pulling the wire-cutting push button 255 backward, which could lead to accidental cutting of the forming pull wire 160 and the tension wire 170.

[0100] In the embodiments of this utility model, both the first connecting part 242 and the second connecting part 2553 are cylindrical structures, and the part of the moving part 2552 near the push-pull part 2551 is connected to the inner wall of the side wall hole 215. The end of the first connecting part 242 near the wire cutting push button 255 extends into the second connecting part 2553. When the wire cutting push button 255 is pressed, the wire cutting push button 255 moves into the outer shell cavity, so that the second connecting part 2553 is sleeved on the first connecting part 242. At this time, the wire cutting assembly can be pushed backward to move backward, thereby driving the core rod 140 to move backward. When the wire cutting push button 255 is released, the pressing spring 256 resets and drives the second connecting part 2553 to disengage from the first connecting part 242. At this time, pushing the wire cutting push button 255 backward can only drive the pressing spring 256 to twist and cannot drive the core rod 140 to move backward.

[0101] Example 3

[0102] like Figure 14 As shown, a plugging device is used in conjunction with a conveying sheath 300 and a loader 400.

[0103] In the embodiments of this utility model, it should be noted that the conveying sheath 300 and the loader 400 are both existing technologies, forming a complete system with the sealing device conveying and forming device of this utility model.

[0104] In the embodiments of this utility model, the front plugging push mechanism 100 and the wire cutting handle 200 are pre-connected together.

[0105] The method of using the sealing device conveying and forming device of this utility model is as follows:

[0106] S10. After the puncture is completed, the delivery sheath 300 is delivered to the left atrium using a guidewire.

[0107] In S10, this step is completely consistent with the existing plug delivery method.

[0108] S20. Completely house the plugger 110 inside the loader 400;

[0109] In S20, it is based on the unique compression characteristics of the plugger 110.

[0110] S30, such as Figure 15 As shown, the head end of the loader 400 is inserted into the tail end of the delivery sheath 300, so that the loader 400 and the delivery sheath 300 are connected as one unit.

[0111] S40, such as Figure 16 As shown, hold the delivery sheath 300 and the loader 400, and continuously push the multi-lumen tube 120 along the axial direction of the delivery sheath 300 into the heart while holding the suture cutter handle 200, until the first MARK point marking ring 123 of the multi-lumen tube 120 is flush with the tail end of the loader 400, and observe with ultrasound.

[0112] After S40 is completed, the front end of the left umbrella disc 111 is flush with the front end of the delivery sheath 300, and the multi-chamber tube 120 moves synchronously with the mandrel 140.

[0113] S50, such as Figure 17 As shown, continue to push the multi-lumen tube 120 along the axial direction of the delivery sheath 300 into the heart until the second MARK point marking ring 124 is flush with the tail end of the loader 400. At this time, the left umbrella disc 111 is completely exposed in the left atrium of the heart. Observe with ultrasound, and then gently pull the shaping wire 160 to make the left umbrella disc 111 fit tightly against the left atrial wall.

[0114] S60, such as Figure 18 and Figure 19 As shown, continue pushing the multi-chamber tube 120 until the third MARK point marking ring 125 is flush with the tail end of the loader 400, at which point the right umbrella disc 112 of the plugger 110 is fully released;

[0115] S70, such as Figure 19 As shown, while keeping the conveying sheath 300 in the same position, slightly pull the wire-cutting handle 200 backward to drive the sheath 130 and the core rod 140 into the conveying sheath 300. During this process, the forming wire 160 pulls the forming knot 1131 into the center hole of the hollow hot-melt tail end 115 to form the first stage of adjustment; or the forming wire 160 pulls the forming knot 1131 into the outside of the hollow hot-melt tail end 115 to form the second stage of adjustment.

[0116] S80, such as Figure 20As shown, while keeping the conveying sheath 300 in the same position, press and push the wire cutting push button 255 backward. The wire cutting push button 255 moves backward and drives the cutting tube 150 backward through the mandrel slider 240 and the mandrel 140, so that the cutting 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 pull wire 160 and the tension wire 170, so that the forming pull wire 160 and the tension wire 170 are cut into two sections, thereby disconnecting the plugger 110 from the wire cutting handle 200.

[0117] S90, such as Figure 21 and 22 As shown, pressing down on the locking button 253 causes the two locking buttons 253 to move relative to each other and, through the cooperation of the corresponding second inclined surface 2531 and the corresponding first inclined surface 2522, drive the locking slider 252 to move backward until it stops against the stop boss 2512. At this time, the locking spring 254 is compressed, the front end of the upper locking slider disengages from the inner wall of the first wire hole 232, and the front end of the lower locking slider disengages from the inner wall of the second wire hole 233, thereby unlocking the forming pull wire 160 and the tension wire 170. At this time, the forming pull wire 160 and the tension wire 170 can be pulled out smoothly.

[0118] S100, first remove the multi-chamber tube 120 and the core tube (core rod 140) from the delivery sheath 300 and the loader 400, and then remove the delivery sheath 300.

[0119] The sealing device for conveying and forming this utility model has the following technical advantages:

[0120] 1. The suture cutting handle 200 and the occluder pushing mechanism 100 are pre-assembled as one unit, which improves the convenience, safety and success rate of suture cutting in the operation and ensures the smooth completion of the operation. At the same time, the suture cutting handle 200 and the occluder 110 are connected by the forming pull wire 160 and the tension wire 170, which simplifies the whole structure and reduces the operation steps and potential risks in the operation.

[0121] 2. The pre-tightening of the left umbrella disc 111, the shaping of the occluder 110, and the push-button suture cutting function can be completed through the suture cutting handle 200. This process can be completed by only one surgeon. This design helps to shorten the operation time, reduce the radiation dose to the surgeon and the patient, and improve the accuracy and safety of the operation.

[0122] 3. The integrated design reduces the learning cost for operators and ensures a smoother surgical process, especially the suture cutting process. Clinicians only need to push the suture cutting push button 255 to complete the procedure, which is efficient and safe.

[0123] The technical solution of this utility model has been described in detail above with reference to specific embodiments. The specific embodiments described are used to help understand the concept of this utility model. Derivations and modifications made by those skilled in the art based on the specific embodiments of this utility model also fall within the protection scope of this utility model.

Claims

1. A plugging device pushing mechanism (100), characterized in that, include: A plug (110), the plug (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), the proximal end of the central channel (121) being fitted with a sheath (130), the sidewall of the sheath (130) having a first slot (133); and a mandrel (140). The mandrel (140) is inserted through the central channel (121) in a manner that allows it to move back and forth while preventing rotation. A wire-cutting tube (150) located within the sheath (130) is fixed to the proximal end of the mandrel (140). A second slot (151) is provided at the proximal end of the wire-cutting tube (150). A forming wire (160) is also present, with one end entering from the distal end of the side channel (122) and passing sequentially through the side channel (122). After passing through the proximal end of the forming knot (1131), the second slot (151), the first slot (133), and the side channel (122), it extends from the distal end of the side channel (122); and a tension line (170), one end of which enters from the distal end of the side channel (122) and passes sequentially through the side channel (122), the winding sealer (110), the second slot (151), the first slot (133), and the side channel (122). After the proximal end of the central channel (122), it extends from the distal end of the side channel (122); wherein, at least one edge of the first slot (133) and the second slot (151) is provided with a cutting edge, and the mandrel (140) moves axially relative to the multi-cavity tube (120) along the central channel (121) to make the second slot (151) misaligned with the first slot (133), thereby cutting the forming wire (160) and the tension wire (170) through the cutting edge.

2. The occluder pushing mechanism (100) according to claim 1, characterized in that, The edge channels (122) are four in number, and the forming wire (160) and tension wire (170) each pass through two edge channels (122).

3. The occluder pushing mechanism (100) according to claim 2, characterized in that, There are two first slots (133), and the forming wire (160) and tension wire (170) each pass through one first slot (133). There is one second slot (151). The edge of the first slot (133) near the edge of the second slot (151) and the edge of the second slot (151) near the edge of the first slot (133) are both provided with cutting edges.

4. The plugging device pushing mechanism (100) according to claim 3, characterized in that, The second slot (151) moves with the mandrel (140) and radially coincides with or is misaligned with the first slot (133).

5. The plugging device pushing mechanism (100) according to claim 4, characterized in that, The sheath (130) has a strip-shaped guide groove (134) axially formed at its distal end, and the outer wall of the wire cutter tube (150) has a guide protrusion (152). The guide protrusion (152) and the strip-shaped guide groove (134) move and cooperate to make the mandrel (140) positioned in the multi-cavity tube (120) in a non-rotating manner.

6. The occluder pushing mechanism (100) according to claim 1, characterized in that, The sealing device (110) includes a left umbrella disc (111), a right umbrella disc (112), a forming wire (113), and a hollow waist section (114) connecting the left umbrella disc (111) and the right umbrella disc (112). The right umbrella disc (112) has a hollow heat-fused tail end (115) at the center of one end facing away from the left umbrella disc (111), which communicates with the hollow waist section (114). One end of the forming wire (113) is fixed on the left umbrella disc (111). The other end is wrapped around the left umbrella disc (111) in sequence, passes through the hollow waist (114) and forms a shaped knot (1131) in the hollow hot melt tail end (115). After the shaped knot (1131) is pulled out from the hollow waist (114), it automatically expands and seals itself in the hollow hot melt tail end (115) or seals itself at the lower end of the hollow hot melt tail end (115). Both the left umbrella disc (111) and the right umbrella disc (112) have built-in flow-blocking membranes (116). The left umbrella disc (111), waist (114), right umbrella disc (112), hollow hot melt tail end (115) and forming knot line (113) are all made of PDO material, and the flow-blocking membrane (116) is made of PLCL material.

7. The plugging device pushing mechanism (100) according to claim 1, characterized in that, 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 part of the cylindrical conical section (131) is provided with a first lead hole (135) and a second lead hole (136). The forming pull wire (160) enters the sheath (130) through the first lead hole (135). The tension wire (170) enters the sheath (130) through the second lead hole (136). The first slot (133) is opened at the part of the straight section (132) near the cylindrical conical section (131).

8. The plugging device pushing mechanism (100) according to claim 1, characterized in that, The outer wall of the tail of the multi-lumen tube (120) is provided with a first MARK mark ring (123), a second MARK mark ring (124) and a third MARK mark ring (125). The first MARK mark ring (123), the second MARK mark ring (124) and the third MARK mark ring (125) are used in conjunction with ultrasound to determine the position of the occluder (110) in real time.

Images