Occluder, occluder manufacturing apparatus, and occluder system

Abstract

The present disclosure provides an occluder, an occluder manufacturing apparatus, and an occluder system. The occluder comprises a first occlusion part and a second occlusion part. The first occlusion part and the second occlusion part are connected by means of a connecting part. The first occlusion part and the second occlusion part are both composed of a mesh structure. The second occlusion part is provided with a cinching member. The cinching member is arranged in a surrounding manner and sequentially passes through meshes at an end of the second occlusion part, and a limiting member is arranged on the cinching member. According to the present disclosure, by arranging the cinching member and the limiting member, the inner diameter of the channel formed by the end of the second occlusion part is reduced, so as to improve the locking success rate of the occluder during surgery. In addition, the recyclable occluder system provided by the present disclosure can solve the problem that the occluder cannot be retracted after an umbrella body is formed.

Description

Occluder, occluder manufacturing device and occluder system

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present disclosure claims priority to Chinese patent applications with application number 2024108897998, entitled “A occluder, an occluder manufacturing device and an occluder system”, filed with the Patent Office of China on July 4, 2024, and application number 2024102043630, entitled “A recyclable occluder system”, filed with the Patent Office of China on February 23, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the technical field of medical devices, and in particular to an occluder, an occluder manufacturing device, and an occluder system. Background Art

[0004] Patent foramen ovale is a congenital heart structural abnormality caused by the failure of a heart passage that should close naturally after birth. Currently, the primary treatment for patent foramen ovale is a device delivered via a catheter to the defect and released to close it.

[0005] The existing occluder is combined with a metal ring. After the occluder is delivered to the patent foramen ovale defect through a catheter and released, medical staff deliver the metal ring to lock the occluder so that the occluder remains locked at the patent foramen ovale defect. Currently, the locking effect between the occluder and the metal ring is poor. Summary of the Invention

[0006] In order to overcome the defect of poor locking effect between the existing occluder and the metal ring, the present disclosure provides an occluder, an occluder manufacturing device and an occluder system. The specific technical solution is as follows:

[0007] The present disclosure provides an occluder, which includes a first occluding part and a second occluding part, wherein the first occluding part and the second occluding part are connected by a connecting part; the first occluding part and the second occluding part are both composed of a mesh structure, and the second occluding part is provided with a binding piece, which is arranged around and passes through the mesh at the end of the second occluding part in sequence, and a limiting piece is provided on the binding piece, wherein the limiting piece includes a plurality of limiting segments, and the plurality of limiting segments are connected on the binding piece and enclosed to form a closed figure.

[0008] The occluder manufacturing device provided in the present disclosure is used to manufacture the above-mentioned occluder, comprising a columnar body, wherein a first end of the columnar body is provided with a plurality of first positioning members (A11, A12...A1 n ) and a plurality of second positioning members (A21, A22...A2n ), the second positioning piece at the first end of the column is located between the first positioning pieces at the first ends of two adjacent columns; the second end of the column is also provided with a plurality of first positioning pieces (B11, B12...B1 n ) and a plurality of second positioning members (B21, B22...B2 n ); the second positioning member at the second end of the column is located between the first positioning members at the second ends of two adjacent columns;

[0009] The occluder manufacturing device is suitable for an occluder braiding method to manufacture the occluder. The occluder braiding method includes: fixing a single wire on A11 and braiding the wires according to A11, B11, A21, B21...A1. n 、B1 n 、A2 n 、B2 n The single wire passes through all the first positioning members and the second positioning members in sequence to form a braided body; wherein the single wire located between the first end of the columnar body and the second end of the columnar body is wound along the outer circumference of the columnar body; wherein, during the braiding process, the single wire is interwoven and passed through the braided paths up and down to form a mesh structure; the middle part of the braided body is fixed, and the two ends of the braided body are squeezed toward the middle part of the braided body to form an occluder having a first sealing part and a second sealing part.

[0010] The occluder system provided by the present disclosure comprises: the occluder; a delivery tangent device;

[0011] A first auxiliary line, one end of the first auxiliary line is arranged on an end surface of the first blocking part of the occluder away from the second blocking part of the occluder, the other end of the first auxiliary line passes through the second blocking part limiting member to pass through the second blocking part and is connected to the conveying and cutting device, the first auxiliary line is provided with one or more clamping parts, the clamping parts are used to pass through the second blocking part through the limiting member under the action of external force, and clamp with the limiting member when the external force disappears.

[0012] The present disclosure has at least the following beneficial effects: the present disclosure provides an occluder, which includes a first occluding part and a second occluding part, which are connected by a connecting part; the first occluding part and the second occluding part are both composed of a mesh structure, and the second occluding part is provided with a binding piece, which is arranged around and passes through the mesh at the end of the second occluding part in sequence, and a limiting piece is provided on the binding piece.

[0013] The occluder provided herein reduces the inner diameter of the channel formed at the end of the second occluding portion by providing a constricting member and a stopper, thereby resolving the problem of poor locking between existing occluders and metal rings and improving the success rate of locking the occluder during surgery. Furthermore, the constricting member constrains the end of the second occluding portion, increasing its structural strength and the stability of the channel formed by the end, while preventing deformation of the end that could affect the locking effect.

[0014] The present disclosure also provides an occluder manufacturing device for manufacturing the above-mentioned occluder, comprising a columnar body, a first end of which is provided with a plurality of first positioning members (A11, A12...A1 n ) and a plurality of second positioning members (A21, A22...A2 n ), the second positioning member at the first end of the column is located between the first positioning members at the first ends of two adjacent columns; the second end of the column is also provided with a plurality of first positioning members (B11, B12...B1 n ) and a plurality of second positioning members (B21, B22...B2 n ); the second positioning member at the second end of the column is located between the first positioning members at the second ends of two adjacent columns; the occluder manufacturing device is suitable for the occluder braiding method to manufacture the above-mentioned occluder, the occluder braiding method comprising: fixing a single wire on A11, and pressing A11, B11, A21, B21...A1 n 、B1 n 、A2 n 、B2 n The braid passes through all the first positioning members and the second positioning members in sequence to form a braided body; wherein, the single wire located between the first end of the column and the second end of the column is wound along the outer circumference of the column; wherein, during the braiding process, the single wire is interwoven and passed through the braided paths up and down to form a mesh structure; the middle part of the braid is fixed, and the two ends of the braid are squeezed toward the middle part of the braid to form an occluder having a first sealing part and a second sealing part.

[0015] The present disclosure provides an occluder manufacturing device suitable for manufacturing an occluder with a single wire, so that in the manufacturing process of the occluder, there is no need to perform complex twisting or bundling of multiple wires, which simplifies the production process, reduces the production difficulty and cost, and avoids mutual interference between the wires; secondly, by arranging a first positioning member and a second positioning member at the first end and the second end of the columnar body, the single wire passes through all the first positioning members and the second positioning members in sequence through a specific weaving sequence to weave into a tubular braided body. During the weaving process, the positioning members are used to accurately fix the wires, ensure the stability of the wires during the weaving process, avoid the misalignment of the wires during the weaving process, improve the accuracy of the braided body, and improve the weaving efficiency; at the same time, the structure of the braided body is stable, and is not prone to deformation, looseness and other problems, which helps to improve the durability and service life of the braided body; and the weaver only needs to pass the wires through the positioning members in sequence according to the preset weaving sequence to complete the weaving work, which greatly simplifies the weaving process and reduces the complexity and technical requirements of the operation.

[0016] The present disclosure also provides an occluder system, comprising: the above-mentioned occluder; a conveying tangent device; a first auxiliary line, one end of the first auxiliary line is arranged on an end surface of the first occluding part of the occluder away from the second occluding part of the occluder, the other end of the first auxiliary line passes through the second occluding part and passes through the second occluding part through a limit member to be connected to the conveying tangent device, and the first auxiliary line is provided with one or more clamping parts, which are used to pass through the second occluding part through the limit member under the action of an external force and clamp with the limit member when the external force disappears.

[0017] The occluder system provided by the present disclosure has the following characteristics: when the first auxiliary line moves in the opposite direction of the intervention direction under the action of an external force, and at least one clamping part passes through the second occluding part through the limiting member, when the occluder is in stable contact with the patent foramen ovale defect, the external force disappears, and the first auxiliary line is clamped with the limiting member through the clamping part to keep the occluder in a locked state, thereby completing the occlusion of the patent foramen ovale defect. The present disclosure achieves locking of the occluder through the cooperation of the clamping part and the limiting member, without the need to use the metal ring in the prior art to lock the occluder, thereby avoiding displacement of the occluder; compared with the prior art, the present disclosure provides a new occluder locking structure, which achieves locking of the occluder through the cooperation of the clamping part on the first auxiliary line and the limiting member, and the operation steps of the first auxiliary line are simple, which simplifies the locking steps of the occluder, and the first auxiliary line can be made of degradable material, reducing the impact of the metal ring made of non-degradable material intervening in the human body.

[0018] Optionally, in some embodiments, in order to solve the problem in the prior art that the occluder cannot be retracted after the umbrella body is formed, the present disclosure provides a retrievable occluder system, comprising: an occluder, having a tubular third section and a first section and a second section that can switch between tubular and disc shapes, the two ends of the third section being connected to the first section and the second section respectively; a connecting mechanism, having a recovery tube and a connecting tube sequentially sleeved from the inside to the outside, the recovery tube being movable along the length direction of the connecting mechanism; an operating mechanism having a grip that can drag the recovery tube to move; a forming auxiliary line, one end of the forming auxiliary line being fixed to an end of the second section away from the third section, and the other end being fixed to the operating mechanism; one end of the connecting tube being fixed to the operating mechanism, and the other end of the connecting tube being detachably connected to the occluder.

[0019] Optionally, the present application also provides a retrievable occluder system, comprising: an occluder having a tubular third section and a first section and a second section that can switch between tubular and disc shapes, the two ends of the third section being connected to the first section and the second section respectively; a molding auxiliary line, one end of the molding auxiliary line being fixed to an end of the second section away from the third section, and the other end being fixed to an operating mechanism, the molding auxiliary line being used to tighten the first section and the second section; a withdrawal line, the withdrawal line being wound around an end of the first section away from the third section, the two ends of the withdrawal line being fixed to a connecting tube, the withdrawal line being used to withdraw the occluder under the action of an external force.

[0020] Compared to the prior art, the retrievable occluder system disclosed herein comprises an occluder, a connecting mechanism, an operating mechanism, and a shaping aid wire. After the occluder is delivered to the heart defect, the shaping aid wire is pulled, pressing the occluder against the connecting mechanism, causing the second section to begin to deform from a tubular shape into a disc shape. The first section also begins to deform from a tubular shape into a disc shape. The elastic knot on the shaping aid wire passes through the end of the occluder's first section away from the third section, keeping the occluder locked, thereby blocking both sides of the heart defect. When the occluder needs to be retrieved during surgery, the gripper can be moved, which drives the retrieval tube, passing through the first and third sections in sequence and pressing against the end of the second section away from the third section. Under the force of the retrieval tube, the first and second sections return from a disc shape to a tubular shape. Finally, the surgeon drags the entire occluder along the shaping aid wire to deploy the first and second sections in the correct position. Implementing the retrievable occluder system disclosed herein can resolve the problem of occluders being unable to be retracted after the umbrella is formed. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0022] FIG1 is a structural schematic diagram of the occluder provided in this embodiment;

[0023] FIG2 is a schematic structural diagram of a second blocking portion provided in this embodiment;

[0024] FIG3 is a schematic structural diagram of a first blocking portion provided in this embodiment;

[0025] FIG4 is a schematic structural diagram of the opening member and the limiting member provided in this embodiment;

[0026] FIG5 is a schematic structural diagram of an occluder manufacturing apparatus provided in this embodiment;

[0027] FIG6 is a schematic structural diagram of a braided body formed by braiding the occluder manufacturing apparatus provided in this embodiment;

[0028] FIG7 is a first structural diagram of the occluder system provided in this embodiment;

[0029] FIG8 is a partial enlarged view of area A in FIG7 ;

[0030] FIG9 is a second structural diagram of the occluder system provided in this embodiment;

[0031] FIG10 is a third structural diagram of the occluder system provided in this embodiment;

[0032] FIG11 is a fourth structural diagram of the occluder system provided in this embodiment;

[0033] FIG12 is a partial enlarged view of area B in FIG11 ;

[0034] FIG13 is a fifth structural diagram of the occluder system provided in this embodiment;

[0035] FIG14 is a partial enlarged view of area C in FIG13;

[0036] FIG15 is a sixth structural diagram of the occluder system provided in this embodiment;

[0037] FIG16 is a seventh structural diagram of the occluder system provided in this embodiment;

[0038] FIG17 is a structural schematic diagram eight of the occluder system provided in this embodiment;

[0039] FIG18 is a ninth structural diagram of the occluder system provided in this embodiment;

[0040] FIG19 is a structural schematic diagram 10 of the occluder system provided in this embodiment;

[0041] FIG20 is a structural schematic diagram 11 of the occluder system provided in this embodiment;

[0042] FIG21 shows a schematic diagram of the overall structure of an occluder after being unfolded into a disc shape in the present disclosure;

[0043] FIG22 shows a left side view of an occluder according to the present disclosure after being unfolded into a disc shape;

[0044] FIG23 is a schematic diagram showing a state in which the occluder, the forming auxiliary wire, and the recovery wire are connected in the present disclosure;

[0045] FIG24 shows a schematic structural diagram of a retrievable occluder system of the present disclosure for removing an end close to the occluder;

[0046] FIG25 shows an exploded schematic diagram of an operating mechanism in a retrievable occluder system of the present disclosure;

[0047] FIG26 shows a cross-sectional schematic diagram of a retrievable occluder system in the present disclosure after the occluder is removed;

[0048] FIG27A shows a partial enlarged view of point A in FIG26 (state before cutting);

[0049] FIG27B shows a partial enlarged view of point A in FIG26 (state before cutting);

[0050] FIG28 shows a cross-sectional schematic diagram of a retrievable occluder system in the present disclosure;

[0051] FIG29 shows a partial enlarged view of point B in FIG28 ;

[0052] FIG30 shows a partial enlarged view of point C in FIG28.

[0053] Figure numerals: 10 - occluder; 11 - first occluding portion; 12 - second occluding portion; 13 - connecting portion; 14 - end piece; 15 - limiting member; 151 - limiting section; 20 - occluder manufacturing device; 21 - columnar body; 22 - wire; 23 - braid; 211 - first end of columnar body; 212 - second end of columnar body; 231 - middle part of braid; 232 - end of braid; 2111 - first positioning member at the first end of columnar body; 2112 - Second positioning member at the first end of the columnar body; 2121 - first positioning member at the second end of the columnar body; 2122 - second positioning member at the second end of the columnar body; 30 - first auxiliary line; 31 - clamping portion; 311 - first end of the clamping portion; 312 - second end of the clamping portion; 313 - recessed portion; 40 - second auxiliary line; 50 - conveying and cutting device; 51 - first tube; 52 - second tube; 53 - third tube; 54 - conveying member; 55 - first cutting member Parts; 56-handle; 511-end cap; 521-first identification member; 522-second identification member; 523-third identification member; 551-driving member; 552-cutting head; 5111-channel; 60-delivery sheath; 70-loader; third section-110; first section-120; second section-130; connecting mechanism-230; recovery tube-210; connecting tube-220; operating mechanism-300; gripping member-310; Auxiliary line-420; node-410; closing end-140; winding assembly-320; cable bundle tube-230; recovery line-500; tangent tube-700; first through hole-2210; retraction line-80; heat shrink tube-90; locking switch-330; fixing block-340; tangent switch-350; second through hole-2310; rigid section-2220; flexible section-2230; second cutting member-710; sheath tube-100. DETAILED DESCRIPTION

[0054] Hereinafter, various embodiments of the present disclosure will be described in more detail. The present disclosure may have various embodiments, and adjustments and changes may be made therein. It should be noted that in the present disclosure, unless otherwise clearly specified and defined, terms such as "installation", "connection", and "fixing" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present disclosure can be understood according to the specific circumstances.

[0055] In the present disclosure, a person of ordinary skill in the art needs to understand that the terms indicating orientation or positional relationships herein are based on the orientation or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present disclosure and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present disclosure.

[0056] As shown in Figures 1 to 4, in an embodiment of the present disclosure, an occluder 10 is provided, which includes a first occluding portion 11, a second occluding portion 12 and a connecting portion 13 located between the first occluding portion 11 and the second occluding portion 12. The first occluding portion 11 and the second occluding portion 12 are both composed of a mesh structure, and the second occluding portion 12 is provided with a binding member 14. The binding member 14 is arranged around and passes through the mesh at the end of the second occluding portion 12 in sequence, and a limiting member 15 is provided on the binding member 14.

[0057] One of the functions of the stopper 15 is to reduce the inner diameter of the cuff 14 to prevent fasteners used to lock the auxiliary line from entering the second sealing portion 12 through the cuff 14, which could result in poor locking or even failure of the occluder 10, thereby improving the success rate of locking. The occluder 10 is made of a fully degradable material, namely, the first sealing portion 11, the second sealing portion 12, the connecting portion 13, the cuff 14, and the stopper 15 are all made of a fully degradable material.

[0058] Traditional occluders are equipped with metal mortises that connect to the delivery system. However, these metal mortises do not degrade after insertion into the human body. This embodiment does not include these mortises, and the occluder 10 is made of a fully biodegradable material, overcoming these shortcomings and minimizing harm to the human body. Furthermore, the traditional metal mortise and the second occluding portion require complex assembly processes. This embodiment eliminates these mortises, making the production of the occluder 10 less complex and improving its production efficiency.

[0059] The occluder 10 provided in this embodiment, by providing a constricting member 14 and a limiting member 15, reduces the inner diameter of the channel formed at the end of the second occluding portion 12, thereby improving the success rate of locking the occluder 10 during surgery. Furthermore, the constricting member 14 constrains the end of the second occluding portion 12, increasing the structural strength of the end of the second occluding portion 12 and the stability of the channel formed by the end of the second occluding portion 12, thereby preventing deformation of the end of the second occluding portion 12, which could affect the locking effect.

[0060] As shown in Figure 6, in an embodiment of the present disclosure, a wire 22 is woven to form a tubular braided body 23 with a mesh structure, and then the braided body 23 is pressed to form an occluder 10, wherein the two ends of the tubular braided body 23 with a mesh structure are squeezed toward the middle to form a first blocking portion 11 and a second blocking portion 12 protruding from the middle portion 231 of the braided body, and the middle portion 231 of the braided body forms a connecting portion 13.

[0061] As shown in Figures 1 to 4, in an embodiment of the present disclosure, the end of the second occluding portion 12 away from the first occluding portion 11 is provided with a tie piece 14, and the diameter of the tie piece 14 is smaller than the diameter of the wire 22. The present disclosure uses a tie piece with a diameter smaller than the diameter of the wire to fix the end of the second occluding portion, so that the outer diameter of the end of the occluder is reduced when the occluder is in a retracted state. During the delivery process, the end of the occluder first contacts the surrounding tissues such as the blood vessel wall. The smaller diameter of the end can reduce the pressure and damage to the surrounding tissues, reduce the risk of complications such as bleeding and hematoma, and can improve the safety of the operation to a certain extent and reduce additional damage to the patient's body; at the same time, the pain and discomfort of the patient during the postoperative recovery process will also be reduced accordingly, which helps to shorten the patient's recovery time and improve the recovery efficiency.

[0062] Secondly, when the occluder passes through narrow passages such as blood vessels, the smaller diameter end reduces the contact area with the vessel wall, thereby reducing friction and resistance during delivery, making it easier to deliver the occluder to the target location. Furthermore, the smaller outer diameter of the end of the occluder allows for greater flexibility around bends in blood vessels, allowing it to more easily pass through and adapt to these structures, reducing surgical risks associated with difficult delivery. Furthermore, it is particularly beneficial for tissue endothelialization.

[0063] Specifically, the wire material is 3-0 wire with a diameter of 0.249mm, the cinch wire is 4-0 wire with a diameter of 0.2mm, and the stopper is 5-0 wire with a diameter of 0.1mm. The cinch member 14 is disposed around and sequentially passes through each mesh at the end of the second sealing portion 12 away from the first sealing portion 11.

[0064] This embodiment provides a constricting piece 14 at the end of the second sealing portion 12 away from the first sealing portion 11 to reduce the inner diameter of the end of the second sealing portion 12 away from the first sealing portion 11, thereby improving the success rate of locking the occluder 10. At the same time, the constricting piece 14 constrains the end of the second sealing portion 12 away from the first sealing portion 11, increasing the structural strength and stability of the end of the second sealing portion 12, and preventing deformation of the end of the second sealing portion 12, which could affect the locking effect.

[0065] The end of the first sealing portion 11 away from the second sealing portion 12 is also equipped with a constricting member 14. The constricting member 14 is arranged around and sequentially passes through each mesh at the end of the first sealing portion 11 away from the second sealing portion 12. In this embodiment, the constricting member 14 constrains the end of the first sealing portion 11, which is composed of a mesh structure, through the constricting member 14, thereby increasing the structural strength of the end of the first sealing portion 11, increasing the stability of the first sealing portion 11, and preventing the first sealing portion 11 from deforming, thereby affecting the sealing effect.

[0066] As shown in Figures 1 to 4 , in the disclosed embodiment, a limiting member 15 is provided on the mouthpiece 14 at the end of the second occluding portion 12 distal from the first occluding portion 11. The limiting member 15 includes a plurality of limiting segments 151, which are connected and enclosed on the mouthpiece 14 to form a closed pattern. By providing the limiting member 15, the inner diameter of the passage at the end of the second occluding portion 12 distal from the first occluding portion 11 is further reduced in this embodiment, thereby improving the locking effect and, in turn, the stability of the occluder 10 when in the locked state, ensuring that the occluder 10 remains locked for a long time to occlude the patent foramen ovale defect.

[0067] The diameter of the stopper 15 is smaller than that of the opening member 14. The starting and ending ends of the stopper 15 are secured to the opening member 14 by tying a knot. In the embodiment of the present disclosure, a plurality of stopper segments 151 are sequentially connected on the opening member 14 to enclose and form a closed pattern.

[0068] In the disclosed embodiment, the crotch piece 14 has multiple wrapping locations. The starting end of the stopper 15 is fixed to the crotch piece 14, and the ending end of the stopper 15 passes through the multiple wrapping locations in sequence before being fixed to the crotch piece 14. The stopper 15 located between two wrapping locations is the stopper segment 151. In this embodiment, the stopper 15 is wrapped around the crotch piece 14 to form multiple stopper segments 151, which simplifies the installation steps of the stopper 15 and the crotch piece 14.

[0069] In the disclosed embodiment, multiple limiting segments 151 are connected on the opening member 14 and enclosed to form any of a star, a cross, or a triangle. This embodiment allows the limiting member 15 to contact each point on the opening member 14 according to a defined pattern, simplifying the installation of the limiting member 15 and facilitating its installation. It also reduces the inner diameter of the limiting member 15, improving the engagement effect.

[0070] In another embodiment of the present disclosure, the stopper 15 includes an enclosing portion and two or more extension portions, the enclosing portion being connected end to end to form a closed figure, one end of the extension portion being disposed on the enclosing portion, and the other end extending away from the enclosing portion and disposed on the crotch piece 14, with the two or more extension portions being spaced apart circumferentially along the enclosing portion to secure the enclosing portion to the crotch piece 14. The closed figure formed by the enclosing portions being connected end to end is circular, elliptical, polygonal, or irregular in shape.

[0071] As shown in FIG5 , in an embodiment of the present disclosure, an occluder manufacturing device 20 is provided for manufacturing the above-mentioned occluder 10, comprising a columnar body 21, a first end 211 of the columnar body being provided with a plurality of first positioning members 2111 (A11, A12, A13, A14, A15, A16, A17, A18, A19, A20, A210, A211, A220, A230, A240, A250, A260, A270, A280, A29 ... n ) and a plurality of second positioning members 2112 (A21, A22...A2 n ), the second positioning member 2112 at the first end of the column is located between the first positioning members 2111 at the first ends of two adjacent columns; the second end 212 of the column is also provided with a plurality of first positioning members 2121 (B11, B12...B1 n ) and a plurality of second positioning members 2122 (B21, B22...B2 n The second positioning member 2122 at the second end of the column is located between the first positioning members 2121 at the second ends of two adjacent columns.

[0072] The columnar body 21 is a plastic or metal tube with a smooth surface to reduce friction between the wire 22 and the columnar body 21, thereby preventing the surface of the columnar body 21 from rubbing against the wire 22. A plurality of first positioning members 2111 are circumferentially arranged along the first end 211 of the columnar body, and a plurality of second positioning members 2112 are circumferentially arranged along the first end 211 of the columnar body. A plurality of first positioning members 2121 are circumferentially arranged along the second end 212 of the columnar body, and a plurality of second positioning members 2122 are circumferentially arranged along the second end 212 of the columnar body.

[0073] As shown in FIG5 and FIG6, the occluder manufacturing device 20 provided in this embodiment is applicable to the occluder braiding method to form a braided body for manufacturing the above-mentioned occluder 10. The occluder braiding method includes: fixing a single wire 22 on A11 and braiding the wires according to A11, B11, A21, B21...A1 n 、B1 n 、A2 n 、B2 nThe braid 23 is passed through all the first positioning members and the second positioning members in sequence to form a braided body 23; wherein, the single wire 22 located between the first end 211 of the column and the second end 212 of the column is wound along the outer circumference of the column 21; wherein, during the braiding process, the single wire 22 is interwoven and passed through the braided paths up and down to form a mesh structure; the middle part 231 of the braid is fixed, and the two ends 232 of the braid are squeezed toward the middle part of the braid 23 to form an occluder 10 having a first blocking part 11 and a second blocking part 12.

[0074] The present embodiment provides an occluder manufacturing device 20 suitable for manufacturing an occluder 10 using a single wire 22. This eliminates the need for complex twisting or bundling of multiple wires during the manufacturing process, simplifying the production process, reducing production difficulty and cost, and avoiding interference between the wires. Furthermore, by providing first and second positioning members at both the first and second ends 211 and 212 of the columnar body, the wire 22 passes through all of the first and second positioning members in a specific weaving sequence to form a cylindrical braid 23. During the weaving process, the positioning members precisely secure the wire 22, ensuring its stability during the weaving process and preventing misalignment of the wire 22, thereby improving the precision and efficiency of the braid 23. Furthermore, the braid 23 maintains a stable structure, is less susceptible to deformation and looseness, and contributes to improving its durability and service life. Furthermore, the braider only needs to pass the wire 22 through the positioning members in a predetermined weaving sequence to complete the weaving process, significantly simplifying the weaving process and reducing operational complexity and technical requirements.

[0075] The occluder manufacturing apparatus provided in this embodiment forms a braided body, wherein one end portion 232 of the braid is extruded toward the middle of the braid 23 to form the second occluding portion 12. Furthermore, the opening of the cylindrical braid end 232 is extruded to form a passage at the end of the second occluding portion 12. The occluder manufacturing apparatus provided in this embodiment simplifies subsequent processing steps of the braid 23, allowing the passage at the end of the second occluding portion 12 to be formed immediately after extrusion, thereby reducing the number of processing steps for the occluder 10.

[0076] In the embodiment of the present disclosure, a detachable connection structure (not shown in the figure) is provided between at least one of the first and second positioning members and the columnar body 21 to adjust the distance between two adjacent first positioning members and the distance between two adjacent second positioning members. This allows the braider to adaptively adjust the distance between two adjacent first positioning members and the distance between two adjacent second positioning members according to the size and density of the braided body actually required, thereby increasing the scope of application of the occluder manufacturing device. The detachable connection structure includes one of a plug-in connection structure, a snap-on connection structure, and a magnetic connection structure, but is not limited thereto.

[0077] As shown in Figure 5, in the embodiment of the present disclosure, a sliding connection structure (not shown) is provided between at least one of the first and second positioning members and the columnar body 21 to adjust the distance between adjacent first and second positioning members. This allows the braider to adaptively adjust the distance between adjacent first and second positioning members based on the size and density of the braid required, thereby expanding the applicability of the occluder manufacturing device.

[0078] Optionally, the first and second positioning members are hook-shaped. Optionally, the distance between two adjacent first positioning members is between 1 mm and 10 mm. Optionally, the distance between two adjacent second positioning members is between 1 mm and 10 mm; and the distance between adjacent first and second positioning members is between 2 mm and 10 mm. Optionally, the height of the first positioning member is between 1 mm and 10 mm, and the height of the second positioning member is between 1 mm and 10 mm.

[0079] As shown in Figures 1 to 4 and Figures 7 to 20, in an embodiment of the present disclosure, an occluder system is provided, comprising: the above-mentioned occluder 10; a conveying tangent device 50; a first auxiliary line 30, one end of the first auxiliary line 30 is arranged on an end face of the first occluding portion 11 of the occluder away from the second occluding portion 12 of the occluder, the other end of the first auxiliary line 30 passes through the second occluding portion 12 and passes through the second occluding portion 12 through the limit member 15 to be connected to the conveying tangent device 50, and the first auxiliary line 30 is provided with one or more clamping portions 31, which are used to pass through the second occluding portion 12 through the limit member 15 under the action of an external force and to clamp with the limit member 15 when the external force disappears.

[0080] In the occluder system provided in this embodiment, when the first auxiliary wire 30 moves in the opposite direction of the intervention direction under the action of external force, at least one clamping portion 31 passes through the second occluding portion 12 through the limiter 15. When the occluder 10 is in stable contact with the patent foramen ovale defect, the first auxiliary wire 30 is clamped with the limiter 15 through the clamping portion 31 to keep the occluder 10 in a locked state and seal the patent foramen ovale defect. Then, the conveying member 54 is driven to move by the handle 56 to cut off the first auxiliary wire 30 in the first tube 51, completing the occlusion operation. This embodiment achieves locking of the occluder 10 through the cooperation of the clamping portion 31 and the limiting member 15, thereby preventing the occluder 10 from shifting. Compared with the prior art, this embodiment provides a new occluder locking structure, which achieves locking of the occluder 10 through the cooperation of the clamping portion 31 on the first auxiliary line 30 and the limiting member 15. The operation steps of the first auxiliary line 30 are simple, which simplifies the locking steps of the occluder 10. The first auxiliary line 30 can be made of completely degradable materials, reducing the impact of non-degradable materials on the human body.

[0081] Another traditional occluder is locked in conjunction with a metal ring, but the metal ring cannot be degraded after entering the human body. This embodiment overcomes the defects of the traditional occluder system and completes the locking of the occluder through the cooperation of the occluder 10 made of fully degradable materials and the first auxiliary line 30. The occluder 10 and the first auxiliary line 30 inserted into the human body have a fully degradable function, which reduces the harm to the human body.

[0082] As shown in Figures 1-4 and 7-20, in an embodiment of the present disclosure, the occluder system further includes: a second auxiliary line 40 connected to the second occluding portion 12, for driving the occluder 10 to move under the action of an external force; and a delivery and tangent device 50 pre-connected to the occluder 10 via the first auxiliary line 30 and the second auxiliary line 40. In the occluder system provided in this embodiment, the occluder 10 and the delivery and tangent device 50 are connected via the first auxiliary line 30 and the second auxiliary line 40, allowing the occluder 10 and the delivery and tangent device 50 to be pre-installed. Medical personnel do not need to spend time connecting the occluder 10 to the delivery and tangent device 50 during surgery, saving surgical time and improving ease of use.

[0083] The occluder system provided in this embodiment locks the occluder 10 through the first auxiliary line 30, and drives the first occluding part 11 and the second occluding part 12 to retract through the second auxiliary line 40 in cases where the occluder 10 is displaced, the occluder 10 cannot completely close the patent foramen ovale defect, or the operation fails. The present disclosure only configures two auxiliary lines to achieve the locking and retraction of the occluder 10, and has a simple structure. Compared with the existing technology, the present disclosure does not need to set up multiple operating lines, which simplifies the structure of the occluder system and the surgical operation process. Moreover, the first auxiliary line 30 and the second auxiliary line 40 have the same moving direction, which will not cause confusion of the first auxiliary line 30 / the second auxiliary line 40, nor will it cause the first auxiliary line 30 / the second auxiliary line 40 to be knotted. In addition, the operation steps of the first auxiliary line 30 and the second auxiliary line 40 are simple, which simplifies the operation steps of the occluder.

[0084] As shown in Figures 1 to 4 and Figures 7 to 20, in the embodiment of the present disclosure, the conveying and cutting device 50 includes a first tube body 51, a second tube body 52, a third tube body 53, a conveying member 54, a first cutting member 55 and a handle 56. One end of the conveying member 54 is fixed to the handle 56 and passes through the second tube body 52 and the third tube body 53 in sequence and then connected to the first tube body 51. The first auxiliary line 30 extends from the end of the first tube body 51 into the first tube body and passes through the side wall of the first tube body 51 to exit the first tube body 51. Located between the conveying member 54 and the second tube body 52; the second auxiliary line 40 extends from the end of the first tube body 51, passes through the first tube body 51 from the side wall of the first tube body 51, and is located between the conveying member 54 and the third tube body 53; one end of the first cutting member is set on the handle, and the other end passes through the second tube body and the third tube body in sequence and is located in the first tube body. The first cutting member 55 is used to move relative to the first tube body 51 under the drive of the handle 56 to cut the first auxiliary line 30 and the second auxiliary line 40.

[0085] As shown in Figures 11 and 12, in an embodiment of the present disclosure, the number of the clamping parts 31 is more than two, and the more than two clamping parts 31 are sequentially arranged on the first auxiliary line 30, and before the first auxiliary line 30 is subjected to no external force, the clamping part 31 is located in at least one of the first blocking part 11, the connecting part 13, and the second blocking part 12. Particularly, the distance between the first-ranked clamping part 31 and the last-ranked clamping part 31 is greater than the distance between the first blocking part 11 and the second blocking part 12 after they are fully retracted. Particularly, the occluder 10 is made of an elastic material, and the external force applied to the first auxiliary line 30 to cause the clamping part 31 to pass through the limiter 15 is greater than the force required for the second blocking part 12 to generate elastic deformation, and the reset force applied by the first blocking part 11 to the first auxiliary line 30 is less than the force required for the second blocking part 12 to generate elastic deformation.

[0086] As shown in Figures 11 to 14, in an embodiment of the present disclosure, the first end 311 of the clamping portion is closer to the first blocking portion 11 than the second end 312 of the clamping portion, and the distance between the outer wall of the first end 311 of the clamping portion and the first auxiliary line 30 is greater than the distance between the outer wall of the second end 312 of the clamping portion and the first auxiliary line 30, so that the clamping portion 31 passes through the limiting member 15 under the action of external force and is clamped with the limiting member 15 through the first end 311 of the clamping portion.

[0087] In this embodiment, the first end 311 and the second end 312 of the clamping portion are provided with different sizes, so that when the clamping portion 31 passes through the limiting member 15, the second end 312 of the clamping portion can easily pass through the limiting member 15, and only the first end 311 of the clamping portion applies an extrusion force to the inner wall of the limiting member 15, thereby reducing the friction force on the inner wall of the limiting member 15 and reducing the wear of the inner wall of the limiting member 15 by the first end 311 of the clamping portion.

[0088] In the embodiment of the present disclosure, the angle between the outer wall of the clamping portion 31 and the first auxiliary line 10 is between 10° and 80°. In this embodiment, the first end 311 of the clamping portion gradually decreases toward the second end 312 of the clamping portion, thereby preventing the uneven outer wall of the clamping portion 31 from causing wear on the inner wall of the limiter 15, thereby preventing the outer wall of the clamping portion 31 from affecting the limiting function of the limiter 15. The cross-section of the clamping portion 31 is triangular, quasi-triangular, trapezoidal, quasi-trapezoidal, V-shaped, or V-shaped, but is not limited thereto.

[0089] In the embodiment of the present disclosure, a curved surface is formed between the outer wall of the first end 311 of the clamping portion and the outer wall of the second end 312 of the clamping portion to reduce wear on the stopper 15 caused by the clamping portion 31. The angle between the line connecting the outer wall of the first end 311 of the clamping portion and the outer wall of the second end 312 of the clamping portion and the first auxiliary line 10 is between 10° and 80°.

[0090] As shown in Figures 11 to 14, in an embodiment of the present disclosure, the first end 311 of the clamping portion is recessed toward the second end 312 of the clamping portion to form a recessed portion 313, and the angle between the side wall of the recessed portion and the first auxiliary line 30 is between 0° and 75°. The recessed portion 313 is used to accommodate the restraining member 14 and / or accommodate a closed figure formed by multiple limiting segments 151 when the clamping portion 31 is clamped with the limiting member 15.

[0091] In this embodiment, a recessed portion 313 is provided to accommodate the closing member 14 of the position-limiting member 15 and / or the closed pattern or a portion thereof, thereby keeping the first end 311 of the engaging portion away from the closing member 14 and / or the closed pattern, thereby preventing failure of the engaging portion 31 to engage the position-limiting member 15. The inner diameter of the recessed portion 313 is larger than the outer diameter of the closed pattern formed by the plurality of position-limiting segments 151. The inner diameter of the recessed portion 313 is larger than the outer diameter of the closing member 14.

[0092] As shown in Figures 11 to 14, in this embodiment, the first end 311 of the clamping portion is recessed toward the second end 312 of the clamping portion to form a recessed portion 313. The recessed portion 313 gives the first end 311 of the clamping portion a pointed shape. In this embodiment, the recessed portion 313 gives the first end 311 of the clamping portion a pointed shape, so that when the clamping portion 31 is engaged with the limiting member 15, the first end 311 of the clamping portion can pass through the gap between the mesh or closed pattern of the second blocking portion 12 and the constricting member 14 and enter the second blocking portion 12.

[0093] As shown in Figures 11 to 14, in the embodiment of the present disclosure, the clamping portion 31 is in the shape of a fishbone barb, so that when the clamping portion 31 is clamped with the limiting member 15, the barb portion of the clamping portion 31 can enter the second sealing portion 12 through the mesh or closed pattern of the second sealing portion 12 and the gap between the closing member 14, so as to increase the clamping stability between the clamping portion 31 and the limiting member 15.

[0094] The occluder system provided in this embodiment is configured to be used together with a delivery sheath 60 . The occluder 10 is located inside the delivery sheath 60 . Medical personnel push the delivery member 54 to move the first tube body 51 , so that the first occluding portion 11 and the second occluding portion 12 move to expose the delivery sheath 60 .

[0095] As shown in FIG15 , the first occluding portion 11 and the second occluding portion 12 both have a retracted state within the delivery sheath 60 and a released state outside the delivery sheath 60. In the embodiment of the present disclosure, the occluder system further includes a loader 70. During use, the occluder 10 is pre-installed in the loader 70, which is in communication with the delivery sheath 60. The second tube 52 is then advanced toward the distal end of the occluder system. Driven by the second tube 52, the occluder 10 moves within the loader 70 and into the delivery sheath 60.

[0096] As shown in Figures 15 and 16, in an embodiment of the present disclosure, at least three identification members are provided on the second tube body 52, and the at least three identification members include a first identification member 521, a second identification member 522 and a third identification member 523 arranged in sequence; when the occluder system is in use, when the first identification member 521 moves to the proximal end of the loader 70, the first blocking portion 11 and the second blocking portion 12 are both located in the delivery sheath 60 and are both in a retracted state, and the end of the first blocking portion 11 away from the second blocking portion 12 is located at the distal end of the delivery sheath 60; when the second identification member 522 moves to the proximal end of the loader 70, the first blocking portion 11 is located outside the delivery sheath 60 and is in a released state, and the second blocking portion 12 is located inside the delivery sheath 60 and is in a retracted state; when the third identification member 523 moves to the proximal end of the loader 70, the first blocking portion 11 and the second blocking portion 12 both extend out of the delivery sheath 60 and are both in a released state.

[0097] This embodiment allows medical staff to determine the position and status of the first blocking part 11 and the second blocking part 12 by the moving position of the first identification part 521, the second identification part 522 and the third identification part 523. There is no need to use X-rays to locate the first blocking part 11 and the second blocking part 12, which can reduce the use of X-rays and reduce the impact of X-rays on medical staff and patients.

[0098] As shown in Figures 17 and 20, in this embodiment, an end cap 511 is provided at the end of the first tube body 51. The end cap 511 is provided with a channel 5111. The first auxiliary line 30 and the second auxiliary line 40 both extend into the first tube body 51 through the channel 5111 and pass through the side wall of the first tube body 51 to exit the first tube body 51. Optionally, the provision of the end cap 511 prevents the first auxiliary line 30 and the second auxiliary line 40 from rubbing against the distal end of the first tube body 51, thereby damaging the first and second auxiliary lines. The side walls of the channel 5111 are provided with rounded corners to reduce friction between the side walls of the channel 5111 and the first and second auxiliary lines 30 and 40.

[0099] As shown in Figures 19 and 20, in the embodiment of the present disclosure, the first cutting member 55 includes a driving member 551 and a cutting head 552. The cutting head 552 is movably disposed within the first tube 51. One end of the driving member 551 is movably disposed on the handle 56, and the other end passes through the second tube 52 and the third tube 53 in sequence, then extends into the first tube 51 to connect with the cutting head 552. The driving member 551 is configured to move relative to the handle 56 under the drive of the handle 56, thereby driving the cutting head 552 to move relative to the first tube 51. In the embodiment of the present disclosure, the third tube 53 is a heat shrink tube to secure the second auxiliary line 40 to the conveyor 54.

[0100] Among some existing technologies, the patent foramen ovale occluders currently on the market are mainly metal occluders. However, due to some disadvantages of metal occluders themselves, such as the lifelong existence of metal occluders after implantation, which deprives patients of the channel for re-interventional treatment of other heart diseases, the long-term presence in the human body may cause some complications, and some people are allergic to nickel-titanium alloys, etc., this has made degradable occluders a current research hotspot.

[0101] Degradable occluders can be degraded within a certain period of time, and after degradation, there is almost no foreign matter left in the heart, which not only achieves the function of occlusion but also minimizes the harm to the human body. However, degradable occluders also have some defects that cannot be ignored. First, the shape memory performance of degradable occluders is not as good as that of nickel-titanium alloy occluders. After the degradable occluder passes through the channel to reach the defect site, it often has a double shuttle shape. This requires that in order for the degradable occluder to achieve the same occlusion effect as the metal occluder, it must be assisted in the molding of the degradable occluder. The current technology is generally: by increasing The molding auxiliary line 420 assists in the molding of the occluder. The molding auxiliary line 420 is fixedly connected to the head end of the umbrella of the occluder away from the handle end. The other end of the molding auxiliary line 420 is outside the body. The surgeon can tighten the molding auxiliary line 420 outside the body, and the auxiliary line pulls the umbrella to shape. Generally, an elastic knot is designed on the molding line. A hole is provided at the tail end of the umbrella of the occluder. The size relationship between the elastic knot and the hole is that the knot is larger than the hole. By pulling the molding auxiliary line 420, the elastic knot on the molding line passes through the hole at the tail end of the umbrella through elastic deformation, thereby achieving the effect of assisting the umbrella molding and locking the umbrella.

[0102] At this point, another problem that cannot be ignored arises. Due to the presence of the forming auxiliary line 420 and the elastic knot, the elastic knot cannot be withdrawn after passing through the hole at the tail end of the umbrella body. If during the operation, due to interference from other factors, it is impossible to withdraw the umbrella body after it is formed and locked, the occluder can only be removed by forcible pulling or surgical operation at the release position, which is not ideal for both the surgeon and the patient.

[0103] In some embodiments, in order to solve the problem that the occluder 10 cannot be retracted after the umbrella body is formed, please refer to Figures 21 to 30. The present disclosure provides a retrievable occluder system, including: an occluder 10, having a tubular third section 110 and a first section 120 and a second section 130 that can switch between tubular and disc forms, and the two ends of the third section 110 are respectively connected to the first section 120 and the second section 130; a connecting mechanism 20, which is sequentially provided with a recovery tube 210 and a connecting tube 220 from the inside to the outside, and the recovery tube 210 can move along the length direction of the connecting mechanism 20; an operating mechanism 30, which has a gripping member 310 that can drag the recovery tube 210 to move; a forming auxiliary line 420, one end of the forming auxiliary line 420 is fixed to an end of the second section 130 away from the third section 110, and the other end is fixed to the operating mechanism 30; one end of the connecting tube 220 is fixed to the operating mechanism 30, and the other end of the connecting tube 220 is detachably connected to the occluder 10.

[0104] Compared to the prior art, the retrievable occluder system disclosed herein comprises an occluder 10, a connecting mechanism 20, an operating mechanism 30, and a shaping auxiliary wire 420. After the occluder 10 is delivered to the heart defect site, the shaping auxiliary wire 420 is pulled, causing the occluder 10 to be pressed against the connecting mechanism 20, thereby causing the second section 130 to begin to deform from a tubular shape into a disc shape. The first section 120 also begins to deform from a tubular shape into a disc shape. The elastic knot on the shaping auxiliary wire passes through the first section of the occluder away from the third section, keeping the occluder locked, thereby blocking both sides of the heart defect site. When the occluder 10 needs to be retrieved during surgery, the gripping member 310 can be moved, which drives the retrieval tube 210 to move, causing the retrieval tube 210 to pass through the first section 120 and the third section 110 in sequence and to press against the end of the second section 130 away from the third section 110. Under the force of the retrieval tube 210, the first section 120 and the second section 130 return from a disc shape to a tubular shape. Finally, the doctor drags the entire occluder 10 along the shaping aid wire 420, deploying the first and second sections 120 and 130 to the correct location. The retrievable occluder system disclosed herein can resolve the issue of the occluder 10 being unable to be retracted after the umbrella is formed. The doctor then releases the entire occluder 10 to the correct location, then pulls the auxiliary shaping aid wire 40 to assist in shaping and release the occluder 10.

[0105] Generally, a degradable mesh is provided on the first section 120 and the second section 130 to occlude the foramen ovale. The first section 120 and the second section 130 are made of a degradable material. Degradable materials include one or more copolymers of polylactic acid, poly-L-lactic acid, poly-D-lactic acid, polyol, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyanhydride, polyphosphate, polyurethane, polycarbonate, and silk fibroin. Of course, the occluder 10 can also be coated with an anticoagulant layer, such as heparin, to prevent thrombosis and its spread, reduce complications, and lower patient mortality. The occluder 10 can also be coated with a developing coating to facilitate the doctor's accurate positioning of the patent foramen ovale during surgery. The recovery tube 210 and the connecting tube 220 are generally made of flexible materials so that they can be bent.

[0106] In some embodiments, referring to FIG. 23 , a node 410 is provided at one end of the shaping auxiliary line 420 close to the occluder 10 , and the node 410 can pass through or be stuck at the outer opening 140 of the first section 120 .

[0107] The occluder 10 is initially tubular, and at this time, the node 410 of the molding auxiliary wire 420 is inside the second section 130. When the molding auxiliary wire 420 is pulled, one end of the molding auxiliary wire 420 pulls the two ends of the second section 130 of the molding auxiliary wire 420 to begin to approach, gradually changing from a tubular shape to a disc shape. Continue to pull the molding auxiliary wire 420, the node 410 passes through the third section 110 and the first section 120, the node 410 squeezes the closing 140 of the first section 120 and drills out from the closing 140. At this time, release the molding auxiliary wire 420, and the node 410 also gets stuck at the outer closing 140 of the first section 120. It should be noted that the node 410 can be a knotted structure, a fishbone wire, or a spring buckle. The connection method between the second section 130 and the molding auxiliary wire 420 is not unique, and can be knotted, riveted, or a line symmetrically passing through the molding auxiliary wire 420 to achieve connection, etc.

[0108] In some embodiments, referring to Figures 24-26 , the operating mechanism 30 further includes a winding assembly 320 , to which the shaping auxiliary wire 420 is fixed. Rotating the winding assembly 320 can wind up the shaping auxiliary wire 420. In this embodiment, to prevent the shaping auxiliary wire 420 from being accidentally pulled, a winding assembly 320 is provided on the operating mechanism 30 , which can be rotated to wind up the shaping auxiliary wire 420. The winding assembly 320 is generally a rotating shaft to which one end of the shaping auxiliary wire 420 is fixed. Optionally, a knob is provided at the connection to the rotating shaft to facilitate the doctor's rotation of the winding assembly 320.

[0109] In some embodiments, referring to Figures 28-29, a retrieval line 500 is further included. The retrieval line 500 is wound around the end of the second section 130 away from the third section 110 and passes through the first section 120 and the third section 110. Both ends of the retrieval line 500 are fixed to the operating mechanism 30. Of course, the retrieval line 500 also serves as a guide because the retrieval line 500 is passed through the retrieval tube 210. The retrieval line 500 can guide the movement of the retrieval tube 210, thereby ensuring that the occluder 10 can be restored from the double-disc shape to the tubular shape.

[0110] In some embodiments, referring to Figures 26, 27A, and 27B, the connecting mechanism 20 further includes a cable tie 230, within which the connecting tube 220 is sheathed. Generally, the auxiliary molding wires 420 are located outside the connecting tube 220, allowing them to be bundled within the cable tie 230 to prevent contamination. In some embodiments, the cable tie 230 further includes a second through-hole 2310 to facilitate insertion of the auxiliary molding wires 420. Because the auxiliary molding wires 420 are disposed between the cable tie 230 and the connecting tube 220, a second through-hole 2310 is provided in the cable tie 230 to facilitate insertion of the auxiliary molding wires 420.

[0111] In some embodiments, as shown in Figures 28 and 30 , a retraction line 80 is further included. The retraction line 80 is routed around the end of the first section 120 distal from the third section 110, with both ends of the retraction line 80 secured to the connecting tube 220. The retraction line 80 facilitates the dragging of the occluder 10. One end of the retraction line 80 is attached to the end of the occluder 10 proximal to the connecting tube 220. If the occluder 10 needs to be retrieved, it can be repositioned and released after it has become tubular.

[0112] In some embodiments, heat shrink tubes 90 are provided at both ends of the withdrawal line 80 to secure the withdrawal line 80. The withdrawal line 80 needs to be secured, so heat shrink tubes 90 are provided at both ends of the withdrawal line 80. By heating the heat shrink tubes 90, the two ends of the withdrawal line 80 are secured to the outside of the connecting tube 220.

[0113] In some embodiments, please refer to Figures 25, 26, 27A and 27B, the connecting mechanism 20 also includes a tangent tube 700, and a first through hole 2210 is provided on the connecting tube 220. The tangent tube 700 is arranged between the recovery tube 210 and the connecting tube 220 and can slide. The withdrawal line 80 passes through the first through hole 2210. When the tangent tube 700 and the connecting tube 220 move relative to each other, the port of the tangent tube 700 can cut off the withdrawal line 80 at the first through hole 2210, and the operating mechanism 30 has a tangent switch 350 for dragging the tangent tube 700 to move.

[0114] After the occluder 10 is correctly installed in the patient's body, it is necessary to separate the occluder 10 from the connecting mechanism 20. The occluder 10 and the connecting mechanism 20 are generally screwed together, and the occluder 10 and the connecting mechanism 20 are separated by rotating the connecting mechanism 20. Although the withdrawal line 80 is made of a degradable material, it is best not to leave too much in the human body. At this time, the tangent switch 350 is moved to drive the tangent tube 700 to move, so that the tangent tube 700 and the first through hole 2210 of the connecting tube 220 form a shearing force on the withdrawal line 80. Finally, the withdrawal line 80 that is broken into two parts can be pulled out at the operating mechanism 30.

[0115] In the present disclosure, the occluder 10 and the connecting mechanism 20 may be connected by a retraction line 80. The occluder 10 and the connecting mechanism 20 may be disconnected by cutting the retraction line 80.

[0116] In some embodiments, the connecting tube 220 is provided with a first through-hole 2210, through which the molding aiding wire 420 passes. When the cutting tube 700 and the connecting tube 220 move relative to each other, the end of the cutting tube 700 can cut the molding aiding wire 420 at the first through-hole 2210. Similarly, the molding aiding wire 420 can also be cut, but a portion of the molding aiding wire 420 will inevitably remain in the human body. The molding aiding wire 420 can also be degraded.

[0117] In some embodiments, the operating mechanism 30 further includes a locking switch 330. Pressing the locking switch 330 locks the grip 310, which can be a grip. The locking switch 330 locks the grip 310 to prevent the physician from misoperating the grip 310 and causing it to move, thereby changing the configuration of the occluder 10. The locking switch 330 can be a knob or a button; any method that restricts the movement of the grip 310 falls within the scope of protection of this disclosure.

[0118] In some embodiments, the operating mechanism 30 further includes two fixing blocks 340, each of which fixes one end of the recovery line 500. The fixing blocks 340 are typically detachably connected to the main body of the operating mechanism 30, and the recovery line 500 is removed by pulling the fixing blocks 340. Typically, the recovery line 500 is cut at the operating mechanism 30, and then all the recovery lines 500 are pulled out.

[0119] In some embodiments, referring to Figures 26, 27A, and 27B, the connecting tube 220 includes a flexible section 2230 and a rigid section 2220. The first through-hole 2210 is provided in the rigid section 2220. The tangent tube 700 is provided with a second cutting member 710 at the end proximal to the occluder 10. Because tangents require rigidity, the connecting tube 220 is composed of the flexible section 2230 and the rigid section. The tangent tube 700 is provided with a second cutting member 710 at the end proximal to the occluder 10. The second cutting member 710, in conjunction with the rigid section, facilitates better tangents. The second cutting member 710 and the rigid section may be made of nickel-titanium alloy or stainless steel.

[0120] It should be noted that the diameters of the flexible section 2230 and the rigid section 2220 can be different. Typically, the rigid section 2220 has a larger diameter. In some embodiments, the flexible section 2230 and the rigid section 2220 are fixedly connected, and the second cutting member 710 and the tangent tube 700 are fixedly connected. In this embodiment, the flexible section 2230 and the rigid section are fixedly connected, and the second cutting member 710 and the tangent tube 700 are fixedly connected. The second cutting member 710 and the rigid section 2220 can be retrofitted, reducing the difficulty of integrally forming and assembling the connecting mechanism 20.

[0121] In some embodiments, a sheath tube 100 is further included, and a second cutting piece 710 is provided on the outer circumference of the sheath tube 100. The sheath tube 100 serves to guide the recovery tube 210 and is generally assembled separately from the second cutting piece 710 and the rigid section 2220 during production.

[0122] Note that the above are only preferred embodiments of the present disclosure and the technical principles employed. Those skilled in the art will understand that the present disclosure is not limited to the specific embodiments herein, and that various obvious changes, readjustments, and substitutions can be made by those skilled in the art without departing from the scope of protection of the present disclosure. Therefore, although the present disclosure has been described in more detail through the above embodiments, the present disclosure is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present disclosure, and the scope of the present disclosure is determined by the scope of the appended claims.

[0123] The above are only preferred embodiments of the present disclosure and are not intended to limit the present disclosure. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present disclosure should be included in the scope of protection of the present disclosure. Industrial Applicability

[0124] The present disclosure reduces the inner diameter of the channel formed at the end of the second occluding portion by providing a constricting member and a limiting member, thereby improving the success rate of locking the occluder during surgery; in addition, the recyclable occluder system provided by the present disclosure can solve the problem that the occluder cannot be retracted after the umbrella body is formed.

Claims

1. An occluder, characterized in that: The occluder comprises a first occluding portion and a second occluding portion, wherein the first occluding portion and the second occluding portion are connected via a connecting portion; The first sealing part and the second sealing part are both composed of a mesh structure. The second sealing part is equipped with a constriction piece, which is arranged around and passes through the mesh at the end of the second sealing part in sequence. A limiting piece is provided on the constriction piece, and the limiting piece includes multiple limiting segments. Multiple limiting segments are connected on the constriction piece and enclosed to form a closed figure.

2. The occluder according to claim 1, characterized in that: The first sealing part is also equipped with a constriction piece, which is arranged around and passes through the mesh at the end of the first sealing part in sequence; the closed figure formed by connecting and enclosing multiple limiting sections on the constriction piece includes any one of a star shape, a tic-tac-toe shape or a triangle.

3. The occluder according to claim 1, characterized in that: The limiting part includes an enclosing portion and two or more extension portions, the enclosing portions are connected end to end to form a closed figure, one end of the extension portion is arranged on the enclosing portion, and the other end extends away from the enclosing portion and is arranged on the restraining part, and the two or more extension portions are arranged at intervals along the circumference of the enclosing portion to fix the enclosing portion on the restraining part.

4. An occluder manufacturing device, characterized in that: An occluder for manufacturing the occluder according to any one of claims 1 to 7, comprising a columnar body, wherein a first end of the columnar body is provided with a plurality of first positioning members (A11, A12...A1n) and a plurality of second positioning members (A21, A22...A2n), wherein the second positioning member at the first end of the columnar body is located between two adjacent first positioning members at the first ends of the columnar body; a second end of the columnar body is also provided with a plurality of first positioning members (B11, B12...B1n) and a plurality of second positioning members (B21, B22...B2n); and the second positioning member at the second end of the columnar body is located between two adjacent first positioning members at the second ends of the columnar body; The occluder manufacturing device is suitable for an occluder braiding method to manufacture the occluder according to any one of claims 1 to 3, and the occluder braiding method comprises: fixing a single wire on A11, and passing through all the first positioning members and the second positioning members in the order of A11, B11, A21, B21...A1n, B1n, A2n, B2n to form a braided body; wherein, the single wire located between the first end of the columnar body and the second end of the columnar body is wound along the outer circumference of the columnar body; wherein, during the braiding process, the single wire is interwoven and passed through the braided paths up and down to form a mesh structure; the middle part of the braided body is fixed, and the two ends of the braided body are squeezed toward the middle part of the braided body to form an occluder having a first sealing part and a second sealing part.

5. The occluder manufacturing device according to claim 4, characterized in that: A detachable connection structure is provided between at least one of the first positioning member and the second positioning member and the columnar body, so as to adjust the distance between two adjacent first positioning members and the distance between two adjacent second positioning members; And / or, a sliding connection structure is provided between at least one of the first positioning member and the second positioning member and the columnar body to adjust the distance between adjacent first positioning members and second positioning members; and / or, the distance between two adjacent first positioning members is between 1 mm and 10 mm; and / or, the distance between two adjacent second positioning members is between 1 mm and 10 mm; and / or, the distance between adjacent first positioning members and second positioning members is between 2 mm and 10 mm; And / or, the height of the first positioning member is between 1 mm and 10 mm; And / or, the height of the second positioning member is between 1 mm and 10 mm.

6. An occluder system, characterized in that: include: The occluder according to any one of claims 1 to 3, comprising a delivery tangent device; A first auxiliary line, one end of the first auxiliary line is arranged on an end surface of the first blocking part of the occluder away from the second blocking part of the occluder, the other end of the first auxiliary line passes through the second blocking part limiting member to pass through the second blocking part and is connected to the conveying and cutting device, the first auxiliary line is provided with two or more clamping parts, the clamping parts are used to pass through the second blocking part through the limiting member under the action of external force, and clamp with the limiting member when the external force disappears.

7. The occluder system according to claim 6, characterized in that: The occluder system further comprises: a second auxiliary line connected to the second blocking portion and configured to drive the occluder to move under the action of an external force; The delivery and cutting device is pre-connected with the occluder through the first auxiliary line and the second auxiliary line.

8. The occluder system according to claim 7, characterized in that: The conveying and cutting device includes a first tube body, a second tube body, a third tube body, a conveying member, a first cutting member and a handle, one end of the conveying member is fixed on the handle, and the other end passes through the second tube body and the third tube body in sequence and is connected to the first tube body; the first auxiliary line extends from the end of the first tube body, passes through the first tube body from the side wall of the first tube body, and is located between the conveying member and the second tube body; the second auxiliary line extends from the end of the first tube body, passes through the first tube body from the side wall of the first tube body, and is located between the conveying member and the third tube body; one end of the first cutting member is arranged on the handle, and the other end passes through the second tube body and the third tube body in sequence and is located in the first tube body. The first cutting member is used to move relative to the first tube body under the drive of the handle to cut the first auxiliary line and the second auxiliary line.

9. The occluder system according to claim 8, characterized in that: The cutting member includes a driving member and a cutting head. The cutting head is movably arranged in the first tube body. One end of the driving member is movably arranged on the handle, and the other end passes through the second tube body and the third tube body in sequence and then extends into the first tube body to be connected with the cutting head. The driving member is used to move relative to the handle under the drive of the handle, thereby driving the cutting head to move relative to the first tube body.

10. The occluder system according to any one of claims 6 to 9, characterized in that: The first end of the clamping portion is closer to the first blocking portion than the second end of the clamping portion, and the distance between the outer wall of the first end of the clamping portion and the first auxiliary line is greater than the distance between the outer wall of the second end of the clamping portion and the first auxiliary line.

11. The occluder system according to any one of claims 6 to 10, characterized in that: The angle between the outer wall of the clamping part and the first auxiliary line is between 10° and 80°; and / or, the first end of the clamping part is recessed toward the second end of the clamping part to form a recessed part, and the angle between the side wall of the recessed part and the first auxiliary line is between 0° and 75°; and / or, the first end of the clamping part is recessed toward the second end of the clamping part to form a recessed part, and the recessed part makes the first end of the clamping part pointed; and / or, the clamping part is in the shape of a fishbone barb.

12. The occluder system according to claim 8 or 9, characterized in that: An end cap is provided at the end of the first tube body. A channel is provided on the end cap. The first auxiliary line and the second auxiliary line both extend into the first tube body through the channel and pass through the side wall of the first tube body to exit the first tube body.

13. The occluder system according to claim 8 or 9, characterized in that: At least three identification members are provided on the second tube body, and the at least three identification members include a first identification member, a second identification member and a third identification member that are spaced apart; Used when the occluder system is in use, when the first identification member moves to the set position, the first sealing part and the second sealing part are both in a retracted state; when the second identification member moves to the set position, the first sealing part is in a released state, and the second sealing part is in a retracted state; when the third identification member moves to the set position, the first sealing part and the second sealing part are both in a released state.

14. A retrievable occluder system, characterized in that: include: The occluder comprises a tubular third section and a first section and a second section capable of switching between a tubular shape and a disc shape, wherein both ends of the third section are connected to the first section and the second section respectively; A connecting mechanism, in which a recovery tube and a connecting tube are sequentially sleeved from the inside to the outside, and the recovery tube can move along the length direction of the connecting mechanism; an operating mechanism, having a gripping piece that can drag the recovery tube to move; a forming auxiliary line, one end of the forming auxiliary line is fixed to an end of the second section away from the third section, and the other end is fixed to the operating mechanism; one end of the connecting tube is fixed to the operating mechanism, and the other end of the connecting tube is detachably connected to the occluder.

15. The retrievable occluder system according to claim 14, characterized in that: The shaping auxiliary line is provided with a node at one end close to the occluder, and the node can pass through and be stuck at the outer closing part of the first section; and / or the node is any one of a knot, a fishbone wire or a spring buckle.

16. The retrievable occluder system according to claim 14 or 15, characterized in that: The operating mechanism further includes a winding assembly, the auxiliary molding line is fixed on the winding assembly, and the auxiliary molding line can be wound by rotating the winding assembly.

17. The retrievable occluder system according to claim 14 or 15, characterized in that: The invention also includes a recovery line, which is wound around the end of the second section away from the third section and passes through the first section and the third section, and both ends of the recovery line are fixed to the operating mechanism; the connecting mechanism also includes a wire harness tube, and the connecting tube is sleeved inside the wire harness tube; And / or, the cable bundle tube further includes a second through hole to facilitate the insertion of the auxiliary forming wire.

18. The retrievable occluder system according to any one of claims 14 to 17, characterized in that: It also includes a withdrawal line, which is wound around the end of the first section away from the third section, and both ends of the withdrawal line are fixed on the connecting tube; heat shrink tubes are provided at both ends of the withdrawal line to fix the withdrawal line.

19. The retrievable occluder system according to claim 18, characterized in that: The connecting mechanism further includes a tangent tube, the connecting tube being provided with a first through hole, the tangent tube being slidably sleeved between the recovery tube and the connecting tube, the retraction line passing through the first through hole, and when the tangent tube and the connecting tube move relative to each other, the end of the tangent tube can cut the retraction line at the first through hole, and the operating mechanism is used to drag the tangent tube to move the tangent switch; The connecting tube is provided with a first through hole, and the forming auxiliary line passes through the first through hole. When the cutting tube and the connecting tube move relative to each other, the end of the cutting tube can cut the forming auxiliary line at the first through hole.

20. A retrievable occluder system, characterized in that: include: The occluder comprises a tubular third section and a first section and a second section capable of switching between a tubular shape and a disc shape, wherein both ends of the third section are connected to the first section and the second section respectively; A molding auxiliary line, one end of which is fixed to the end of the second section away from the third section, and the other end is fixed to the operating mechanism, and the molding auxiliary line is used to tighten the first section and the second section; a withdrawal line, which is wound around the end of the first section away from the third section, and both ends of the withdrawal line are fixed to the connecting tube, and the withdrawal line is used to withdraw the occluder under the action of external force.

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