Occluder pushing mechanism and occluder conveying and forming device

Abstract

The invention discloses an occluder pushing mechanism and an occluder conveying and forming device.The occluder pushing mechanism comprises an occluder, a multi-cavity tube, a core rod, a forming pull wire and a tensioning wire, and the occluder conveying and forming device comprises the occluder pushing mechanism and a wire cutting handle. The thread trimming handle comprises a shell, a multi-cavity tube fixing ring, a thread leading device, a core rod sliding block, a thread locking assembly and a thread trimming assembly. According to the occluder conveying and forming device, the thread trimming handle and the occluder pushing mechanism are preassembled into a whole, the surgical operation process is optimized, the convenience and safety of surgical operation are remarkably improved, the thread trimming success rate is greatly increased, and smooth implementation of the surgery is guaranteed; meanwhile, connection between the thread trimming handle and the plugging device is established through the forming pull thread and the tensioning thread, the overall structural design is simplified, and surgical operation steps and potential risks are effectively reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an occluder pushing mechanism and an occluder conveying and forming device. Background Art

[0002] Patent foramen ovale is a structural abnormality of congenital heart disease, currently treated clinically with a transcatheter occluder. There are two traditional types of patent foramen ovale occluders: 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, and can be released simply by loosening the mandrel. However, the future development trend is likely to be towards biodegradable occluders, which generally have more complex delivery systems. Due to the inelastic nature of the material, biodegradable occluders require a forming step during the occlusion surgery, with the occluder's thread being fixed to the tail end to complete the occlusion. However, the current method requires the clinician to thread the occluder and delivery system together before surgery, and then connect the thread to the handle. Furthermore, after the occlusion surgery, the operator must cut one of the threads with scissors and then pull the uncut thread out of the body. This process is tedious and requires the operator to be more careful.

[0003] The shortcomings of the existing catheter-delivered occluder when used are as follows:

[0004] 1. Traditional metal patent foramen ovale occluders are constructed with a nickel-titanium alloy framework and a polyester fiber flow-blocking membrane. They utilize a double-disc design, leveraging the self-expanding properties of nickel-titanium alloy to clamp the foramen ovale and achieve closure. However, because metal stents are non-degradable, long-term retention in the human heart presents numerous potential risks. For example, nickel-titanium ion precipitation can affect human health; during MRI examinations, the metal material can generate heat, posing a threat to patient safety.

[0005] 2. While existing biodegradable PFO occluders have achieved breakthroughs in material degradability, they still have significant drawbacks. To facilitate real-time visualization of the occluder's position via DSA angiography, most commercially available biodegradable occluders incorporate a platinum-iridium imaging ring. However, this non-degradable ring poses unknown risks if left in the heart for a long time, limiting the clinical effectiveness of biodegradable occluders.

[0006] 3. The existing biodegradable patent foramen ovale occluder system is significantly complex in terms of operation. During surgery, the occluder and delivery system must be temporarily assembled. The thread trimming step after the occluder is released is particularly cumbersome. Furthermore, the occluder tail and the delivery system mandrel are threaded together, requiring clinicians to learn specialized operating techniques. This not only prolongs the clinician's learning cycle, but also limits the product's scope of use and increases manufacturing costs.

[0007] 4. The design of the existing patent foramen ovale occluder delivery and molding device also has room for improvement. Currently, this system typically consists of a core rod, a delivery sheath, and a loader. The surgical procedure relies on DSA angiography, which can cause certain radiation hazards to patients and clinical staff. Furthermore, at the end of the procedure, the clinician must use scissors to cut the molding pull wire and completely pull it out of the body, making the process complex and requiring improvement. Summary of the Invention

[0008] In view of this, the present invention proposes an occluder pushing mechanism and an occluder conveying and molding device to solve at least one of the above technical problems.

[0009] To achieve the above object, the present invention adopts the following technical solutions:

[0010] An occluder pushing mechanism, comprising:

[0011] an occluder, the occluder comprising a shaped knot;

[0012] A multi-lumen tube having a central channel and at least one side channel concentric with the central channel, a sheath fixedly covering the proximal end of the central channel, and a first slot formed on a side wall of the sheath;

[0013] A mandrel, the mandrel being provided with a central passage in a manner that allows for forward and backward movement and prevents rotation, a wire cutting tube located within a sheath being fixedly disposed at a proximal end of the mandrel, and a second slot being provided at the proximal end of the wire cutting tube;

[0014] A forming pull wire, one end of which enters the distal end of the side channel, passes through the side channel, the forming knot, the second slot, the first slot, and the proximal end of the side channel, and then extends from the distal end of the side channel;

[0015] and a tensioning wire, one end of which enters from the distal end of the side channel, passes through the side channel, the winding occluder, the second slot, the first slot, the proximal end of the side channel, and extends from the distal end of the side channel;

[0016] 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 axially along the central channel relative to the multi-lumen tube to cause the second slot to be misaligned with the first slot, thereby cutting the forming pull line and the tensioning line through the cutting edge.

[0017] In order to better implement the above technical solution, optionally, the number of the side channels is four and they are arranged around the side channels, and the forming wire and the tensioning wire each pass through two side channels.

[0018] Optionally, there are two first slots, the forming pull wire and the tensioning wire pass through one first slot respectively, and there is one second slot, and the edge of the first slot close to the second slot and the edge of the second slot close to the first slot are both provided with cutting edges.

[0019] Optionally, the second slot is radially overlapped with or offset from the first slot as the core rod moves.

[0020] Optionally, a strip guide groove is axially opened at the distal end of the sheath, and a guide protrusion is provided on the outer wall of the wire cutting tube. The guide protrusion and the strip guide groove are movably matched to enable the core rod to be arranged in the multi-lumen tube in a rotation-stopping manner.

[0021] Optionally, the occluder includes a left umbrella disc, a right umbrella disc, a molded knot line, and a hollow waist connecting the left umbrella disc and the right umbrella disc; a hollow hot-melt tail end connected to the hollow waist is provided at the center of one end of the right umbrella disc away from the left umbrella disc; one end of the molded knot line is fixed on the left umbrella disc, and the other end is sequentially wound around the left umbrella disc, passes through the hollow waist, and forms a molded knot in the hollow hot-melt tail end; after the molded knot is pulled out of the hollow waist, it automatically expands and seals in the hollow hot-melt tail end or seals at the lower end of the hollow hot-melt tail end; and both the left and right umbrella discs are provided with built-in flow-blocking membranes;

[0022] Among them, the left umbrella plate, waist, right umbrella plate, hollow hot-melt tail end and molding knot line are all made of PDO material, and the flow-blocking film is made of PLCL material.

[0023] 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 portion of the cylindrical conical section is provided with a first lead hole and a second lead hole, the formed pull wire enters the sheath through the first lead hole, the tensioning wire enters the sheath through the second lead hole, the formed pull wire enters the sheath through the second lead hole, and the first slot is opened in the straight section close to the cylindrical conical section.

[0024] Optionally, the outer wall of the tail 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, and 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.

[0025] An occluder conveying and molding device comprises the occluder pushing mechanism described in any one of the above items, characterized in that it includes a wire cutting handle.

[0026] In order to better implement the above technical solution, optionally, the thread trimmer handle includes:

[0027] The shell has a front end hole, a side wall hole, an upper wall hole, a lower wall hole, an upper wire hole and a lower wire hole, the upper wire hole is used for forming the pull wire to enter and exit the shell, and the lower wire hole is used for tensioning the wire to enter and exit the shell;

[0028] a multi-lumen tube fixing ring, which is coaxial with the front end hole and fixedly arranged at the front portion of the inner cavity of the shell, and is used to fix the multi-lumen tube extending from the front end hole into the inner cavity of the shell;

[0029] A wire guide, the wire guide being fixedly arranged in the inner cavity of the shell and located behind the fixing ring of the multi-lumen tube, the wire guide comprising a wire entry hole, a first wire hole and a second wire hole, the wire entry hole being coaxial with the front end hole, and the wire entry hole, the first wire hole and the second wire hole forming a herringbone structure;

[0030] A mandrel slider is disposed in the inner cavity of the shell in a manner that allows it to move forward and backward along the center line of the front end hole and is located behind the wire guide, and is used to connect with the end of the mandrel extending into the inner cavity of the shell from the front end hole;

[0031] A locking wire assembly includes an upper locking wire assembly and a lower locking wire assembly. The upper locking wire assembly passes through the upper wall hole and is used to lock and unlock the forming wire passing through the first wire hole. The lower locking wire assembly passes through the lower wall hole and is used to lock and unlock the tensioning wire passing through the second wire hole.

[0032] and a wire cutting assembly, which slides through the side wall hole and is connected to the core rod slider, and is used for driving the core rod slider to move forward and backward relative to the multi-lumen tube.

[0033] Beneficial effects of the present invention:

[0034] The occluder pushing mechanism of the present invention has the following technical effects:

[0035] 1. The occluder is made of two biodegradable materials, PDO and PLCL. Within two years after occlusion, it will degrade into water and carbon dioxide and be excreted from the body, which is harmless to the human body.

[0036] 2. During interventional surgery, clinicians can determine the position of the occluder in the delivery sheath by observing the position of the MARK point marking ring, avoiding the use of DSA angiography and eliminating the need for a platinum-iridium development ring to be added to the occluder, further improving surgical safety and minimizing trauma.

[0037] 3. The occluder adopts a two-stage adjustment method, which is convenient for clinical physicians to adjust during surgery to achieve the best occlusion effect for patients.

[0038] 4. The occluder, multi-lumen tube, and mandrel are mechanically interlocked and secured using molded pull wires and tensioning wires, replacing traditional threaded coupling. This eliminates the precise alignment and multi-step assembly process required for threaded connections, significantly improving interventional device deployment efficiency. It also mitigates the risk of micron-sized debris shedding caused by metal thread friction, reducing potential complications of intravascular foreign body embolism. The use of biocompatible polymer wires to create a mechanical conduction pathway avoids ion leaching caused by metal interface contact, further optimizing device safety.

[0039] The occluder delivery and molding device of the present invention has the following technical effects:

[0040] 1. The pre-installed trimming handle and occluder pushing mechanism optimize the surgical operation process, significantly improve the convenience and safety of the surgical operation, greatly increase the success rate of trimming the wire, and ensure the smooth implementation of the operation. At the same time, the connection between the trimming handle and the occluder is established through the forming pull wire and the tensioning wire, which simplifies the overall structural design and effectively reduces the surgical operation steps and potential risks.

[0041] 2. The trimmer handle can be used to pre-tighten the left umbrella disc, shape the occluder, and trim the thread by pushing the button. This process can be completed by the main surgeon alone. This design helps shorten the operation time, reduce the radiation dose received by the surgeon and the patient, and improve the accuracy and safety of the operation.

[0042] 3. The integrated design reduces the operator's learning cost and ensures a smoother operation throughout the entire surgical process, especially the thread trimming process. The clinician only needs to push the thread trimming button to complete the process, which is efficient and safe. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a front view of an occluder delivery and molding device according to embodiment 1 of the present invention;

[0044] Figure 2 yes Figure 1 Front view of the pushing mechanism of the middle occluder;

[0045] Figure 3 yes Figure 2 Schematic diagram of the occluder;

[0046] Figure 4 yes Figure 3 Schematic diagram of the middle occluder from the initial structure to the first-level occlusion form;

[0047] Figure 5 yes Figure 3 Schematic diagram of the middle occluder from the initial structure to the second-level occlusion form;

[0048] Figure 6 yes Figure 2 Exploded diagram;

[0049] Figure 7 yes Figure 6 A three-dimensional schematic diagram of the middle structure at the first angle;

[0050] Figure 8 yes Figure 6 A three-dimensional schematic diagram of the middle structure from a second angle;

[0051] Figure 9 yes Figure 1 Front view of the middle shearing device;

[0052] Figure 10 yes Figure 9 Exploded diagram;

[0053] Figure 11 yes Figure 10 Schematic diagram of the middle and upper lock wire assembly;

[0054] Figure 12 yes Figure 10 Schematic diagram of the middle shearing component in normal state;

[0055] Figure 13 yes Figure 10 Schematic diagram of the middle trimmer assembly in the pressed state;

[0056] Figure 14 It is a schematic diagram of the combination and explosion of an occluder delivery and molding device, a loader, and a delivery sheath;

[0057] Figure 15 This is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (I);

[0058] Figure 16 This is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (II);

[0059] Figure 17 This is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (III);

[0060] Figure 18 It is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (IV);

[0061] Figure 19 It is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (V);

[0062] Figure 20 It is a schematic diagram of the surgical process of the occluder delivery molding device, delivery sheath, and loader (VI);

[0063] Figure 21This is a schematic diagram of the cooperation between the sheath and the shear tube (the sheath and the shear tube coincide radially, and the forming wire and the tensioning wire are both one wire);

[0064] Figure 22 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 pull wire and the tensioning wire).

[0065] Reference numerals:

[0066] Occluder pushing mechanism 100, occluder 110, left umbrella disc 111, right umbrella disc 112, forming knot line 113, forming knot 1131, hollow waist 114, hollow hot-melt tail 115, and flow-blocking membrane 116;

[0067] Multi-lumen tube 120, central channel 121, side channel 122, first MARK point marking ring 123, second MARK point marking ring 124, third MARK point marking ring 125, sheath 130, cylindrical tapered section 131, straight section 132, first slot 133, strip guide groove 134, first lead wire hole 135, second lead wire hole 136, core rod 140, small diameter portion 141, wire cutting tube 150, second slot 151, cutting edge 152, guide protrusion 152, forming pull wire 160, tensioning wire 170;

[0068] Thread trimmer handle 200, housing 210, front cover 211, front hole 2111, rear cover 212, upper housing 213, upper wall hole 2131, upper thread hole 2132, lower housing 214, lower wall hole 2141, lower thread hole 2142, anti-rotation clip 2143, fixing clip 2144, side wall hole 215;

[0069] Multi-lumen tube fixing ring 220, annular body 221, retaining protrusion 222, retaining groove 223, wire guide 230, wire entry hole 231, first wire hole 232, second wire hole 233, first guide groove 234, protruding ring 234, mandrel slider 240, slider 241, first connecting portion 242, wire locking assembly 250, fixing seat 251, strip groove 2511, stop boss 2512, clamping plate guide 2513, wire locking slider 252, first through hole 2521, first inclined surface 2522, guide portion 2523, wire locking button 253, second inclined surface 2531, wire locking spring 254, thread trimming push button 255, push-pull portion 2551, moving portion 2552, second connecting portion 2553, pressing spring 256;

[0070] Delivery sheath 300;

[0071] Loader 400. DETAILED DESCRIPTION

[0072] 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.

[0073] Example 1

[0074] like Figure 1 As shown, an occluder delivery and molding device includes an occluder pushing mechanism 100 and a thread cutting handle 200.

[0075] like Figure 2 As shown, the occluder pushing mechanism 100 includes an occluder 110 , a multi-lumen tube 120 , a core rod 140 , a forming pull wire 160 and a tension wire 170 .

[0076] like Figure 3-Figure 5 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.

[0077] In an embodiment of the invention, the left umbrella disc 111, the waist 114, the right umbrella disc 112, the hollow hot-melt tail end 115 and the forming 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 all woven by a weaving machine, and after weaving, they are placed in a drying oven 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.

[0078] In the embodiment of the invention, the diameter of the center hole of the hollow hot melt tail end 115 is larger than the diameter of the center hole of the right umbrella plate 112. The center hole 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 4 As shown, the forming knot 1131 is placed in the center hole of the hollow hot melt tail end 115 to form the first level of adjustment; Figure 5As shown, the molding knot 1131 is placed outside the center hole 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.

[0079] 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 pull 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 4 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 5 As shown), the occluder 110 is finally formed.

[0080] 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 covered with a sheath 130, and a first slot 133 is opened on the side wall of the sheath 130.

[0081] In the embodiments of the present invention, it should be noted that the proximal end refers to the end of the same component relatively close to the heart, and the distal end refers to the end of the same component relatively far from the heart.

[0082] The mandrel 140 is arranged to pass through the central passage 121 in a manner that allows it to move forward and backward and prevents rotation. A wire cutting tube 150 located within the sheath 130 is fixedly mounted at the proximal end of the mandrel 140. The wire cutting tube 150 has a second slot 151 defined at its proximal end. The distal end of the mandrel 140 is fixedly mounted within the central hole of the mandrel slider 240.

[0083] Specifically, the wire cutting tube 150 and the core rod 140 are both made of stainless steel. The proximal end of the core rod 140 has a small diameter portion 141. The distal 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.

[0084] 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, the forming knot 1131, the second slot 151, the first slot 133, the side channel 122, the first wire hole 232, and then exits from the upper wire hole 2132.

[0085] The tensioning wire 170, one end of which enters the lower wire hole 2142, passes through the second wire hole 233, the side channel 122, is wrapped around the occluder 110, the second slot 151, the first slot 133, the side channel 122, the second wire hole 233, and then is led out from the lower wire hole 2142;

[0086] The occluder pushing mechanism 100 of the present invention utilizes a forming pull wire 160 and a tensioning wire 170 to fix the occluder 110 to the sheath 130, and at the same time controls the final shaping of the occluder 110 through the forming pull wire 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 forming pull wire 160 and the tensioning wire 170. It has a simple structure and is easy to operate.

[0087] In an embodiment of the present invention, there are four side channels 122 arranged around the side channels 122, and the tensioning wire 170 and the forming pull wire 160 each pass through two side channels 122. The tensioning wire 170 and the forming pull wire 160 are passed through the four side channels 122, so that the tensioning wire 170 and the forming pull wire 160 are routed independently, avoiding the problem of entanglement and knotting, thereby improving the convenience of the operation.

[0088] like Figure 6 As shown, the outer wall of the tail end 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 are used in conjunction with ultrasound to determine the position of the occluder 110 in real time. Specifically, the first MARK point marking ring 123 is used to determine whether the left umbrella disc 111 is flush with the proximal end of the delivery sheath 300 (the specific function will be explained later), the second MARK point marking ring 124 is used to determine whether the left umbrella disc 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 an occluding state.

[0089] like Figure 7 and Figure 8As shown, there are two first slots 133, and the forming pull wire 160 and the tensioning wire 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 a cutting edge 152. The second slot 151 moves with the core rod 140 and radially coincides or is misaligned with the first slot 133, that is, the forming pull wire 160 and the tensioning wire 170 pass through the second slot 151 together and then extend from the two first slots 133 respectively. The provision of the cutting edge 152 can enable the forming pull wire 160 and the tensioning wire 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 forming pull wire 160 and the tensioning wire 170 are cut off by the cutting edge 152.

[0090] In an embodiment of the present invention, a strip guide groove 134 is axially opened 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 guide groove 134 are moved and matched so that the core rod 140 is arranged in the multi-lumen tube 120 in a rotation-stopping 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 152 cuts off the forming pull wire 160 and the tensioning wire 170 in a preset manner.

[0091] 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 forming pull 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 forming pull wire 160 and the tensioning wire 170 here, thereby facilitating entry into the sheath 150.

[0092] like Figures 9 to 13 As shown, the wire cutting handle 200 includes a housing 210, a multi-lumen tube fixing ring 220, a wire guide 230, a mandrel slider 240, a wire locking assembly 250 and a wire cutting assembly.

[0093] like Figure 10 As shown, the housing 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 , which are connected to the inner cavity of the housing 210 .

[0094] The front end hole 2111 is used to pass the multi-lumen tube 120 and the core rod 140 sleeved in the multi-lumen tube 120, the side wall hole 215 is used to pass the wire cutting assembly, the upper wall hole 2131 and the lower wall hole 2141 are used to pass the wire locking assembly 250, the upper wire hole 2132 is used for the forming pull wire 160 to enter and exit the housing 210, and the lower wire hole 2142 is used for the tensioning wire 170 to enter and exit the housing 210;

[0095] In an embodiment of the present invention, in order to facilitate the assembly of components inside the shell 210, the shell 210 is assembled by a front cover 211, a rear cover 212, an upper shell 213 and a lower shell 214. The shell 210 is a common structure and only needs to meet the assembly requirements. The specific structure will not be repeated.

[0096] The multi-lumen tube fixing ring 220 is coaxial with the front end hole 2111 and fixedly arranged at the front portion of the inner cavity of the shell 210 , and is used to connect with the end portion of the multi-lumen tube 120 extending from the front end hole 2111 into the inner cavity of the shell 210 ;

[0097] like Figure 10 As shown, the multi-lumen tube fixing ring 220 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. The two locking protrusions 222 form a locking groove 223 between them. The inner cavity of the shell 210 is provided with a first mounting groove for limiting the multi-lumen tube fixing ring 220 and an anti-rotation clip 2143 that is locked into the locking groove 223. The center hole of the annular body 221 is used to fix the end of the multi-lumen tube 120 extending from the front end hole 2111 into the inner cavity of the shell 210.

[0098] Specifically, the first mounting groove includes an upper half arranged in the upper shell 213 and a lower half arranged in the lower shell 214. The upper half and the lower half together define the multi-lumen tube fixing ring 220, and at the same time, the multi-lumen tube fixing ring 220 is fixed by using the anti-rotation clip 2143 that is inserted into the positioning slot 223.

[0099] like Figure 10 As shown, the wire guide 230 is fixedly arranged in the inner cavity of the shell 210 and is located behind the multi-lumen tube fixing ring 220. The wire guide 230 includes a wire entry hole 231, a first wire hole 232 and a second wire hole 233. The wire entry hole 231 is coaxial with the front end hole 2111, and the wire entry hole 231, the first wire hole 232 and the second wire hole 233 form a herringbone structure;

[0100] Specifically, at least one convex ring 234 is fixed to the upper and lower sides of the front end of the wire guide 230 , and the inner cavity of the shell 210 is provided with a second mounting groove for placing the wire guide 230 and a fixing clip 2144 that is clamped into each convex ring 234 .

[0101] In an embodiment of the present invention, two chain protrusions 234 are fixed at intervals on the upper and lower sides of the front end of the wire guide 230, and the upper shell 213 and the lower shell 214 are fixed with fixed clips 2144 corresponding to the protrusions 234 one by one. The fixed clips 2144 and the protrusions 234 are used to stably fix the wire guide 230 in the shell 210.

[0102] The mandrel slider 240 is disposed in the inner cavity of the housing 210 and is located behind the wire guide 230 in a manner that it can move forward and backward along the center of the front end hole 2111. It is used to fix the mandrel 140 extending from the front end hole 2111 into the inner cavity of the housing 210.

[0103] 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 forming 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 tensioning wire 170 passing through the second wire hole 233.

[0104] The thread trimming assembly slides through the side wall hole 215 and is connected to the mandrel slider 240 to drive the mandrel slider 240 to move back and forth relative to the multi-lumen tube 120 .

[0105] When the wire cutting handle 200 of the embodiment of the present invention is used, the rear parts of the forming pull wire 160 and the tensioning wire 170 are locked based on the wire locking assembly 250, and the wire cutting assembly is used to move backward to drive the core rod 140 and the sheath 120 to move backward, so that the sheath 130 is displaced backward relative to the sheath 130, and the first slot 133 and the second slot 151 are synchronously misaligned, and the forming pull wire 160 and the tensioning wire 170 are cut off by the cutting edge 152, and then the wire locking assembly 250 is pressed to put the forming pull wire 160 and the tensioning wire 170 in an unlocked state. At this time, the disconnected forming pull wire 160 and the tensioning wire 170 can be slowly pulled out from the outside of the shell 210.

[0106] like Figure 10 and Figure 11 As shown, the upper thread locking assembly includes: a fixing seat 251 , a thread locking slider 252 , a thread locking button 253 and a thread locking spring 254 .

[0107] A strip groove 2511 is provided on the upper part of the fixing seat 251, and a stop boss 2512 is provided at the rear end of the strip groove 2511. The wire locking slider 252 is slidably set in the strip groove 2511. A first through hole 2521 is provided in the upper and lower directions of the middle part of the wire locking slider 252, and 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, and the front end of the wire locking spring 254 abuts against the rear end of the wire locking slider 252, and the rear end abuts against the inner cavity of the shell 210.

[0108] Under normal circumstances, the wire locking slider 252 is pushed by the wire locking spring 254, and the front end of the wire locking slider 252 rests against the inner wall of the first wire hole 232 and clamps the forming pull wire 160 there; when it is necessary to draw the wire, press the wire locking button 253 downward, and the wire locking button 253 moves downward and cooperates with the first inclined surface 2522 through the second inclined surface 2531 to drive the wire locking slider 252 to move backward until it rests against the stop boss 2512 and stops. At this time, the wire locking spring 254 is compressed, and the front end of the wire locking slider 252 is disengaged from the inner wall of the first wire hole 232, so that the forming pull wire 160 and the tensioning wire 170 are unlocked. The design of the upper and lower wire locking sliders 252 can fix the rear ends of the forming pull wire 160 and the tensioning wire 170 under normal circumstances.

[0109] Specifically, the rear sides of the first and second thread holes 232, 233 are both open structures. The left and right side walls of the first thread hole 232 are provided with first guide grooves 234 for the front portion of the thread lock slider 252 of the upper thread lock assembly to slide back and forth. The left and right side walls of the second thread hole 233 are provided with first guide grooves 234 for the front portion of the thread lock slider of the lower thread lock assembly to slide back and forth. The front portions of the upper thread lock assembly and the thread lock slider 252 of the upper thread lock 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 thread lock slider 252. The addition of the guide portions 2523 and the first guide grooves 234 can control the precision of the upper and lower thread lock assemblies, thereby improving the reliability of the thread lock assemblies in clamping and fixing the forming wire 160 and the tensioning wire 170.

[0110] like Figure 10 As shown, sliders 241 are symmetrically fixed to the upper and lower ends of the core rod slider 240, the lower end of the upper lock wire assembly fixed seat 251 is provided with a splint guide rail 2513 with damping sliding with the upper end slider 241 of the core rod slider 240, and the lower end of the lower lock wire assembly fixed seat 251 is provided with a splint guide rail 2513 with damping sliding with the lower end slider 241 of the core rod slider 240. Setting the splint guide rail 2513 on the fixed seat 251 can make the overall structure more reasonable and reliable.

[0111] like Figures 12 to 13 As shown, the thread trimming assembly includes a thread trimming push button 255, a pressing spring 256 and a first connecting portion 242. The first connecting portion 242 is fixed to the side wall of the mandrel slider 240 corresponding to the side wall hole 215. The side wall hole 215 is a strip-shaped structure along the front-to-back direction of the shell 210. The thread trimming push button 255 includes a push-pull portion 2551 located outside the shell 210, a moving portion 2552 that slides with the side wall hole 215, and a second connecting portion 2553 located inside the shell 210. The push-pull portion 2551, the moving portion 2552 and the second connecting portion 2553 are connected as a whole. One end of the pressing spring 256 abuts against the first connecting portion 242, and the other end abuts against the second connecting portion 2553.

[0112] Under normal conditions, the pressing spring 256 is in a natural state, the portion of the movable portion 2552 near the second connecting portion 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 portion 242 and the second connecting portion 2553, and the thread trimming push button 255 is locked in the front-to-back direction of the side wall hole 215. When trimming, pressing the thread trimming push button 255 compresses the pressing spring 256, the portion of the movable portion 2552 near the push-pull portion 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 portion 242 and the second connecting portion 2553, and the thread trimming push button 255 is unlocked in the front-to-back direction of the side wall hole 215. Using this thread trimming assembly, clinicians can avoid accidentally cutting the forming wire 160 and the tensioning wire 170 by pushing or pulling the thread trimming push button 255 backward.

[0113] In an embodiment of the present invention, the first connection part 242 and the second connection part 2553 are both cylindrical structures, and the portion of the movable part 2552 close to the push-pull part 2551 is connected to the inner wall of the side wall hole 215, and the end of the first connection part 242 close to the thread trimming push button 255 extends into the second connection part 2553. When the thread trimming push button 255 is pressed, the thread trimming push button 255 moves into the shell cavity so that the second connection part 2553 is sleeved on the first connection part 242. At this time, the thread trimming assembly can be pushed backward to move backward and drive the core rod 140 to move backward. When the thread trimming push button 255 is released, the pressing spring 256 is reset to drive the second connection part 2553 to disengage from the first connection part 242. At this time, pushing the thread trimming push button 255 backward can only drive the pressing spring 256 to twist but cannot drive the core rod 140 to move backward.

[0114] Example 3

[0115] like Figure 14 As shown, an occluder delivery and molding device is used together with a delivery sheath 300 and a loader 400.

[0116] In the embodiment of the present invention, it should be noted that the delivery sheath 300 and the loader 400 are both prior art, and form a complete system with the occluder delivery and molding device of the present invention.

[0117] In the embodiment of the present invention, the occluder pushing mechanism 100 and the thread cutting handle 200 are pre-connected before use.

[0118] The method of using the occluder delivery and molding device of the present invention is as follows:

[0119] S10: After the puncture is completed, the delivery sheath 300 is delivered to the left atrium using a guide wire.

[0120] In S10, this step is completely consistent with the existing occluder delivery method.

[0121] S20, completely storing the occluder 110 in the loader 400;

[0122] In S20 , the occluder 110 is operated based on its unique compression characteristics.

[0123] 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;

[0124] S40, such as Figure 16 As shown, hold down the delivery sheath 300 and the loader 400, hold the thread trimmer handle 200 and continue to push the multi-lumen tube 120 along the axial direction of the delivery sheath 300 toward the heart 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 by ultrasound.

[0125] After S40 is completed, the front end of the left umbrella disc 111 is flush with the front end of the delivery sheath tube 300 , and the multi-lumen tube 120 moves, driving the core rod 140 to move synchronously.

[0126] S50, such as Figure 17 As shown, the multi-lumen tube 120 is continuously pushed along the axial direction of the delivery sheath 300 toward the heart until the second MARK point marking ring 124 is flush with the rear end of the loader 400. At this time, the left umbrella disc 111 is completely exposed in the left atrium of the heart. Ultrasound observation is performed, and then the forming pull wire 160 is slightly pulled to make the left umbrella disc 111 closely adhere to the left atrium wall.

[0127] S60, such as Figure 18 and Figure 19 As shown, the multi-lumen tube 120 is continuously pushed until the third MARK point when the marking ring 125 is flush with the rear end of the loader 400. At this time, the right umbrella disc 112 of the occluder 110 is completely released.

[0128] S70, such as Figure 19 As shown, the posture of the delivery sheath 300 is kept unchanged, and the wire trimming handle 200 is slightly pulled backward to drive the sheath 130 and the core rod 140 into the delivery sheath 300. During this process, the forming pull wire 160 pulls the forming knot 1131 to be placed in the center hole of the hollow hot melt tail end 115 to form the first level of adjustment; or the forming pull wire 160 pulls the forming knot 1131 to be placed outside the hollow hot melt tail end 115 to form the second level of adjustment;

[0129] S80, such as Figure 20As shown, the posture of the delivery sheath 300 is kept unchanged, and the cutting button 255 is pressed and pushed backward. The cutting button 255 moves backward and drives the cutting tube 150 to move backward through the core rod slider 240 and the core rod 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 152 is used to cut the forming pull wire 160 and the tensioning wire 170, so that the forming pull wire 160 and the tensioning wire 170 are cut into two sections, thereby disconnecting the occluder 110 from the cutting handle 200.

[0130] S90, such as Figure 21 and 22 As shown, press the wire locking button 253 downward, the two wire locking buttons 253 move relative to each other and cooperate with the corresponding second inclined surface 2531 and the corresponding first inclined surface 2522 to drive the wire locking slider 252 to move backward until it stops against the stop boss 2512. At this time, the wire locking spring 254 is compressed, and the front end of the upper wire locking slider is separated from the inner wall of the first wire hole 232, and the front end of the lower wire locking slider is separated from the inner wall of the second wire hole 233, so that the forming pull wire 160 and the tensioning wire 170 are unlocked. At this time, the forming pull wire 160 and the tensioning wire 170 can be smoothly pulled out.

[0131] S100 , first withdraw the multi-lumen tube 120 and the core tube (core rod 140 ) from the delivery sheath 300 and the loader 400 , and then withdraw the delivery sheath 300 .

[0132] The occluder delivery and molding device of the present invention has the following technical effects:

[0133] 1. The wire trimming handle 200 and the occluder pushing mechanism 100 are pre-assembled as one, which improves the convenience, safety and success rate of wire trimming during the surgical operation and ensures the smooth completion of the surgical process. At the same time, the wire trimming handle 200 is connected to the occluder 110 through the molded pull wire 160 and the tension wire 170, which simplifies the entire structure, thereby reducing the number of operating steps and potential risks during the surgical process.

[0134] 2. The trimmer handle 200 can be used to pre-tighten the left umbrella disc 111, shape the occluder 110, and trim the thread by pushing the button. This process can be completed by the main surgeon alone. This design helps shorten the operation time, reduce the radiation dose received by the surgeon and the patient, and improve the accuracy and safety of the operation.

[0135] 3. The integrated design reduces the operator's learning cost and ensures that the entire surgical process is smoother for the operator, especially the thread trimming process. The clinician only needs to push the thread trimming button 255 to complete it, which is efficient and safe.

[0136] 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. An occluder pushing mechanism (100), characterized in that: include: 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) fixedly sheathed at the proximal end of the central channel (121), and a first slot (133) formed on a side wall of the sheath (130); A core rod (140) is provided with a central passage (121) in a manner that allows the core rod (140) to move forward and backward and prevent rotation. A wire cutting tube (150) located in the sheath (130) is fixedly provided at the proximal end of the core rod (140). A second slot (151) is provided at the proximal end of the wire cutting tube (150); A forming pull line (160), one end of which enters from the distal end of the side channel (122), passes through the side channel (122), the forming knot (1131), the second slot (151), the first slot (133), the proximal end of the side channel (122), and then extends from the distal end of the side channel (122); and a tensioning wire (170), one end of which enters from the distal end of the side channel (122), passes through the side channel (122), winds around the occluder (110), the second slot (151), the first slot (133), the proximal end of the side channel (122), and extends from the distal end of the side channel (122); At least one edge of the first slot hole (133) and the second slot hole (151) is provided with a cutting edge (152), and the core rod (140) moves axially relative to the multi-lumen tube (120) along the central channel (121) to cause the second slot hole (151) to be misaligned with the first slot hole (133), thereby cutting the forming pull line (160) and the tensioning line (170) through the cutting edge (152).

2. The occluder pushing mechanism (100) according to claim 1, characterized in that: There are four side channels (122) arranged around the side channels (122), and the forming pull wire (160) and the tensioning wire (170) each pass through two side channels (122).

3. The occluder pushing mechanism (100) according to claim 2, characterized in that: There are two first slot holes (133), and the forming pull wire (160) and the tensioning wire (170) respectively pass through one first slot hole (133). There is one second slot hole (151), and the edge of the first slot hole (133) close to the second slot hole (151) and the edge of the second slot hole (151) close to the first slot hole (133) are both provided with a cutting edge (152).

4. The occluder pushing mechanism (100) according to claim 3, characterized in that: The second slot (151) moves with the core rod (140) to coincide with or be misaligned with the first slot (133) in the radial direction.

5. The occluder pushing mechanism (100) according to claim 4, characterized in that: A strip 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 guide groove (134) are movably matched to enable the core rod (140) to be arranged in the multi-lumen tube (120) in a rotation-stopping manner.

6. The occluder pushing mechanism (100) according to claim 1, characterized in that: The occluder (110) comprises a left umbrella disc (111), a right umbrella disc (112), a forming tie 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) communicating with 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 forming tie line (113) is fixed on the left umbrella disc (111). The other end is sequentially wound around the left umbrella disc (111), passes through the hollow waist (114) and forms a molding knot (1131) in the hollow hot melt tail end (115). After being pulled out of the hollow waist (114), the molding knot (1131) 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 built with a flow-blocking film (116); The left umbrella plate (111), the waist (114), the right umbrella plate (112), the hollow hot-melt tail (115) and the forming knot line (113) are all made of PDO material, and the flow-blocking film (116) is made of PLCL material.

7. The occluder 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 portion of the cylindrical conical section (131) is provided with a first lead hole (135) and a second lead hole (136). The formed 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), and the formed pull wire (160) 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).

8. The occluder pushing mechanism (100) according to claim 1, characterized in that: The outer wall of the tail portion 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) are used in conjunction with ultrasound to determine the position of the occluder (110) in real time.

9. An occluder conveying and molding device, comprising the occluder pushing mechanism (100) according to any one of claims 1 to 8, characterized in that: It includes a thread trimmer handle (200).

10. The occluder delivery and molding device according to claim 9, characterized in that: The thread trimmer handle comprises: A housing (210), wherein the housing (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), wherein the upper wire hole (2132) is used for the forming wire (160) to enter and exit the housing (210), and the lower wire hole (2142) is used for the tensioning wire (170) to enter and exit the housing (210); a multi-lumen tube fixing ring (220), the multi-lumen tube fixing ring (220) being coaxial with the front end hole (2111) and fixedly arranged at the front portion of the inner cavity of the shell, and being used to fix the multi-lumen tube (120) extending from the front end hole (2111) into the inner cavity of the shell; A wire guide (230), the wire guide (230) is fixedly arranged in the inner cavity of the shell and is located behind the multi-lumen tube fixing ring (220), the wire guide (230) comprises a wire entry hole (231), a first wire hole (232) and a second wire hole (233), the wire entry hole (231) is coaxial with the front end hole (2111), and the wire entry hole (231), the first wire hole (232) and the second wire hole (233) form a herringbone structure; a mandrel slider (240) disposed in the inner cavity of the housing in a manner movable forward and backward along the center line of the front end hole (2111) and located behind the wire guide (230), and used for connecting with the end of the mandrel (140) extending from the front end hole (2111) into the inner cavity of the housing; A locking wire assembly (250) comprises an upper locking wire assembly and a lower locking wire assembly, wherein the upper locking wire assembly passes through the upper wall hole (2131) and is used to lock and unlock the forming pull wire (160) passing through the first wire hole (232), and the lower locking wire assembly passes through the lower wall hole (2141) and is used to lock and unlock the tensioning wire (170) passing through the second wire hole (233); and a thread cutting assembly, which slides through the side wall hole (215) and is connected to the core rod slider (240), and is used to drive the core rod slider (240) to move forward and backward relative to the multi-lumen tube (120).

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