CN112998769A

CN112998769A - Plugging device, plugging system and knotting method of tightening piece in plugging device

Info

Publication number: CN112998769A
Application number: CN201911313841.7A
Authority: CN
Inventors: 王永胜; 赵江浪; 陈杰; 赵文斌
Original assignee: Hangzhou Nuomao Medtech Co ltd
Current assignee: Hangzhou Nuomao Medtech Co ltd
Priority date: 2019-12-18
Filing date: 2019-12-18
Publication date: 2021-06-22

Abstract

The present invention provides an occluding device for occluding a defect in a vasculature, the occluding device comprising: two plugging discs and a tightening piece, wherein the two plugging discs are used for covering different openings of the defect; the tightening piece comprises a tightening wire which is used for penetrating into the defect and is connected with the two plugging disks, and the length of the tightening wire between the two plugging disks can be adjusted through the free end of the tightening wire. The invention also provides a plugging system provided with the plugging device and a knotting method of the tightening piece in the plugging device.

Description

Plugging device, plugging system and knotting method of tightening piece in plugging device

Technical Field

The invention relates to the field of medical instruments, in particular to an occluder and an occlusion system for occluding defects in a human body and a knotting method for the waist of the occluder.

Background

The Patent Ova are generally closed in the first 1 year after the birth of a fetus, and Patent Ova lformame (PFO) is still not closed if the Patent Ova lformame is larger than 3 years old, and 20-25% of adult patients have incomplete closed Patent Ova. Patent foramen ovale refers to a deformity in which the primary diaphragm and the secondary diaphragm of the fossa ovalis are not completely fused, and a permanent fissure-like defect exists in the middle, thereby causing horizontal shunting of atria.

With the development of science and technology, especially the development of catheter technology, the transcatheter interventional occluder becomes an important method for minimally invasive treatment of congenital heart diseases such as patent foramen ovale, atrial septal defect, ventricular septal defect and patent ductus arteriosus. The transcatheter interventional occluder is a medical instrument commonly used in a transcatheter interventional treatment method, and because the patent foramen ovale and the atrial septal defect are different in anatomy, the patent foramen ovale occluder needs to be improved on the basis of an atrial septal defect occluding device. The patent foramen ovale occluder in the prior art comprises a double-disc occluding surface and a cylindrical slender waist vertical to the double-disc occluding surface, wherein the cylindrical slender waist extrudes and deforms a primary septum and a secondary septum, and the double-disc occluding surface clamps and fixes the deformed defects so as to block blood circulation.

However, the patent foramen ovale occluder in the prior art is only suitable for treating patent foramen ovale with short overlapping of a primary septum and a secondary septum, the patent foramen ovale with long overlapping is difficult to achieve the occluder effect, large residual shunt is easy to generate between the primary diaphragm and the secondary diaphragm after treatment, blood flow velocity changes when flowing through the patent foramen ovale, thrombosis can be induced, the patient needs to prolong the time of anticoagulation treatment, and serious adverse events such as embolism can be caused if formed thrombus enters the blood circulation; moreover, the distance between the double-disc plugging surfaces of the traditional plugging device is fixed, and the distance of the waist cannot be adjusted according to the structure of the foramen ovale, so that the plugging device conforms to the anatomical structure of the foramen ovale.

Disclosure of Invention

The present invention provides an occluding device for occluding a defect in a vasculature, the occluding device comprising: two plugging discs and a tightening piece, wherein the two plugging discs are used for covering different openings of the defect; the tightening piece comprises a tightening wire which is used for penetrating into the defect and is connected with the two plugging disks, and the length of the tightening wire between the two plugging disks can be adjusted through the free end of the tightening wire.

The invention also provides an occlusion system comprising an occluder for occluding a defect in the vasculature and a transporter, the occluder comprising: two plugging discs and a tightening piece, wherein the two plugging discs are used for covering different openings of the defect; the tightening piece comprises a tightening wire which is used for being penetrated in the defect and is connected with the two plugging disks, and the length of the tightening wire between the two plugging disks can be adjusted through the free end of the tightening wire; the conveyor is used for releasing the stopper.

The invention also provides a knotting method of a tightening piece in an occluder, the tightening piece is made by winding and knotting a tightening wire, the tightening wire comprises a locking section, a first section, a second section and an adjusting section which are connected in sequence, and the knotting method comprises the following steps:

enclosing the first section into a coil to obtain a basic wire ring;

penetrating the rest part in the first section out of the basic wire ring to obtain a locking wire ring;

the adjusting section is threaded through the locking wire loop so that the second section forms an adjusting wire loop between the two closure disks of the closure device, thereby obtaining the tightener.

The two plugging disks of the plugging system respectively cover the peripheries of different openings of the defect, the distance between the two plugging disks is controlled by adjusting the length of the tightening wire between the two plugging disks, the fit degree of the two plugging disks and the peripheral tissues of the defect part is favorably improved, and the defect is stably plugged, namely after the plugging device is implanted, the deformation degree of the defect part is ensured to be smaller, the endothelialization of the plugging disks is not influenced, the generation of residual shunt is reduced, the trouble that the plugging device needs to be customized due to the specific defect structure of an individual patient is avoided, the application range of the plugging device is effectively expanded, and more patients can benefit from minimally invasive surgery.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic structural view of a first embodiment of the occlusion system of the present invention when released.

Figure 2 is an enlarged view of the occlusion system of figure 1.

Fig. 3 is an enlarged view of the portion III in fig. 2.

Figure 4 is a schematic view of one of the structures of the support framework of the occluder provided in the first embodiment of the present invention.

Figure 5 is a schematic view of another configuration of the support framework of the occluding device provided by the first embodiment of the invention.

Fig. 6 is a schematic structural view of the support skeleton in fig. 5 provided with a flow-blocking film.

Figure 7 is a schematic view of another configuration of the support framework of the occluding device provided by the first embodiment of the invention.

Figure 8 is a schematic view of another configuration of the support framework of the occluding device provided by the first embodiment of the invention.

Figure 9 is a schematic view of another configuration of the support skeleton of the occluding device provided by the first embodiment of the invention.

Figure 10 is a schematic view of another configuration of the support framework of the occluding device provided by the first embodiment of the invention.

Figures 11-15 are schematic views of the assembly of the occluding disk and the tightening member of the occluding device provided by the first embodiment of the invention.

Figure 16 is a schematic view of the structure of the tightening member of the occluding device provided by the second embodiment of the invention.

Figures 17-20 are schematic drawings showing the knotting of the cinch cord of the occluding device provided by the second embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. In the present invention, the end relatively farther from the operator is the distal end, and the end relatively closer to the operator is the proximal end. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.

Referring to fig. 1-3, the present invention provides an occlusion system 100 comprising an occluding device 20 and a delivery device 50 for releasing the occluding device 20, wherein the occluding device 20 is used to occlude defects in the vasculature, including but not limited to, a patent foramen ovale, an arterial catheter, atrial septal defects, ventricular septal defects, etc., and wherein the defect is a patent foramen ovale 200, which illustrates the advantages of the occlusion system 100 for treating patent foramen ovale, it being understood that the defect can also be other defects as mentioned above.

The occluding device 20 comprises two occluding disks and a tightening member, wherein the two occluding disks are used for covering different openings of the foramen ovale 200, namely two side openings of the foramen ovale 200 in the left atrium and the right atrium; the tightener includes a tightening wire 21, and is formed by winding and knotting the tightening wire 21. The tightening wire 21 is used for being threaded in the oval hole 200 and connecting the two plugging discs; the length of the tightening wire 21 between the two closing disks can be adjusted by means of the free end of the tightening wire 21.

After the occlusion system 100 of the present invention is implanted into a human body, the two occlusion disks respectively cover the openings of the two opposite sides of the foramen ovale 200, i.e., the areas adjacent to the foramen ovale 200 on the two sides of the primary diaphragm 301 and the secondary diaphragm 303 are both covered by the two occlusion disks, and the distance between the two occlusion disks is controlled by adjusting the length of the tightening wire 21 between the two occlusion disks to adapt to the anatomical structure of a patient, which is beneficial to improving the degree of adhesion between the two occlusion disks and the tissues around the foramen ovale 200, thereby stably occluding the foramen ovale 200. After the occluder 20 is implanted, the deformation degree of the two diaphragms (primary diaphragm 301 and secondary diaphragm 303) is ensured to be small, endothelialization of the two diaphragms to the occlusion disc is not influenced, the generation of residual shunt is reduced, the trouble that the occluder needs to be customized due to the specific structure of the oval hole 200 of an individual patient is avoided, the application range of the PFO occluder is effectively expanded, and more patients benefit from minimally invasive surgery.

In embodiments where there are more than 2 openings in the defect, the occluding device 20 is also used to occlude multiple openings in the defect from both sides.

As shown in fig. 2 and 3, the two plugging discs are a first plugging disc 201 and a second plugging disc 205; the tightening wire 21 includes a knot 22, a connecting section 23 connected to the knot 22, and a locking section 24 and an adjusting section 25 connected to the knot 22. Wherein the connecting section 23 is connected between the first plugging disc 201 and the second plugging disc 205, preferably the connecting section 23 is connected to the geometric center of the first plugging disc 201 and/or the connecting section 23 is connected to the geometric center of the second plugging disc 205. Locking segment 24 includes a free end 241 and adjustment segment 25 includes a free end 251; locking section 24, regulation section 25 and knot 22 all set up in the one side that second shutoff dish 205 deviates from first shutoff dish 201, and the length of linkage segment 23 can be adjusted through regulation section 25. The free end 241 of the locking section 24 and the free end 251 of the adjusting section 25 are connected to the conveyor 50, and the free end 251 is pulled by controlling the conveyor 50 to adjust the length of the connecting section 23 between the first blocking disk 201 and the second blocking disk 205, so that the distance between the two blocking disks is adjusted; the free end 241 is pulled by controlling the conveyor 50 to lock the pair of segments 25 by the wire knot 22, so that the distance between the first blocking disk 201 and the second blocking disk 205 is relatively fixed, the distance between the first blocking disk 201 and the second blocking disk 205 is fixed, the relative positions and the close state of the primary diaphragm 301, the secondary diaphragm 303 and the two blocking disks are favorably kept in the operation and after the operation, the withdrawing difficulty of the conveyor 50 is reduced, and the formation of permanent atrial septa by endothelialization of the two diaphragms to the growth of the occluder 20 after the operation is favorably realized.

As shown in fig. 2, since the adjusting section 25 and the locking section 24 are both movable lines connected to the plugging disc, the plugging disc is moved by operating the adjusting section 25 and the locking section 24 independently, and the operability is poor; thus, the tightener also includes a securing wire 26 connected to the carrier 50, and the carrier 50 secures one of the two closure discs to the distal end of the carrier 50 via the securing wire 26. In particular, a fixing thread 26 is connected to the second plugging disc 205, and the fixing thread 26 is used for fixing the second plugging disc 205 at the distal end of the conveyor 50, so as to avoid that the two plugging discs shake simultaneously when the adjusting section 25 and the locking section 24 are pulled, so as to adjust the length of the connecting section 23 and lock the adjusting section 25 by the thread knot 22. In this embodiment, one end of the fixing wire 26 is connected to the middle of the second blocking disk 205, and the other end of the fixing wire 26 is fixed to the conveyor 50.

In this embodiment, as shown in fig. 1, during use, a first occluding disk 201 is delivered by a delivery device 50 to be deployed from and in the left atrium, and a second occluding disk 205 is delivered by a delivery device 50 to be deployed in the right atrium. The connecting section 23 connected between the first blocking disc 201 and the second blocking disc 205 is flexible and adjustable in length, and the connecting section 23 is arranged in the oval hole 200 between the primary diaphragm 301 and the secondary diaphragm 303 in a penetrating manner; adjusting section 25 is pulled to the near-end, makes linkage segment 23 shorten gradually, and the distance between first shutoff dish 201 and the second shutoff dish 205 diminishes gradually promptly, and primary diaphragm 301 is close to each other and is held by first shutoff dish 201 and second shutoff dish 205 with secondary diaphragm 303, and first shutoff dish 201 covers primary diaphragm 301 and secondary diaphragm 303 around oval hole 200 to second shutoff dish 205 covers primary diaphragm 301 and secondary diaphragm 303 around oval hole 200, and oval hole 200 is in the both sides opening of controlling in the atrium respectively by first shutoff dish 201 and second shutoff dish 205 promptly. In this embodiment, the first blocking disc 201 and the second blocking disc 205 both include a supporting frame and a flow blocking membrane disposed on the supporting frame, and the flow blocking membranes on both sides of the foramen ovale 200 can prevent blood from flowing into the foramen ovale 200, so as to prevent blood from flowing into the right atrium from the left atrium, thereby achieving instant blocking. After the occluder 20 is implanted into a human body, the primary diaphragm 301 and the secondary diaphragm 303 climb to the contact positions of the first occluding disk 201 and the second occluding disk 205 to close the foramen ovale 200 after endothelialization is completed, and a complete atrial septum is formed. In a modified embodiment, the density of the supporting skeleton on the two plugging discs is high enough, the flow-blocking membrane is omitted, the endothelialization of the two diaphragms to the plugging discs is not influenced, and the flow distribution or the flow distribution on the oval hole channel is not small, for example, below a preset ratio, which may be 10%, 5%, 3%, etc.

The disc surfaces of the first blocking disc 201 and the second blocking disc 205 may be circular, oval, triangular or other irregular shapes, and the radial area of the first blocking disc 201 may be the same as or different from the radial area of the second blocking disc 205. In this embodiment, the first blocking disk 201 and the second blocking disk 205 are both substantially disk-shaped, and the radial area of the first blocking disk 201 is smaller than the radial area of the second blocking disk 205.

Specifically, as shown in fig. 2, the first blocking disc 201 includes a first supporting framework 2011 and a first blocking film 2013 disposed on the first supporting framework 2011, the first blocking film 2013 may be fixedly attached to an inner surface and/or an outer surface of the first supporting framework 2011, the first blocking film 2013 may also be fixedly disposed on an inner cavity of the first supporting framework 2011, and the first blocking film 2013 at least covers a radial region of the first supporting framework 2011. The tightening wire 21 is connected to the first support framework 2011 and/or the first spoiler 2013, and in this embodiment, the connecting section 23 of the tightening wire 21 is slidably disposed on the first support framework 2011.

The second blocking disc 205 includes a second supporting skeleton 2051 and a second flow blocking film 2053 disposed on the second supporting skeleton 2051, the second flow blocking film 2053 may be fixedly attached to an inner surface and/or an outer surface of the second supporting skeleton 2051, the second flow blocking film 2053 may also be fixedly disposed in an inner cavity of the second supporting skeleton 2051, and the second flow blocking film 2053 at least covers a radial region of the second supporting skeleton 2051. One end of the regulating section 25 passes through the second flow-obstructing membrane 2053 from a slit in the second support skeleton 2051 to connect the knot 22.

The first flow-blocking film 2013 and the second flow-blocking film 2053 can be made of non-degradable polymer material films with good biocompatibility, such as ePTFE (ePTFE) or PET (polyethylene terephthalate) materials; the first blocker film 2013 and the second blocker film 2053 may also be formed from absorbable polymer materials, such as polylactic acid, polycaprolactone, polylactic acid-caprolactone copolymer, and the like. The first and second

flow blocking films

2013, 2053 are fixed to the inner or outer surface of the blocking disc by sewing or gluing for blocking blood flow. In this embodiment, a first flow blocking film 2013 is fixedly attached to the outer surface of the first blocking disc 201; a second flow-blocking film 2053 is fixedly attached to the outer surface of the second plugging disc 205.

The first supporting skeleton 2011 and the second supporting skeleton 2051 are of a woven mesh structure or a frame structure, so that the first blocking disk 201 and the second blocking disk 205 can be sufficiently attached to the surface of the atrial septum. The first support skeleton 2011 and the second support skeleton 2051 are respectively of any one of a single-layer woven mesh structure, a single-layer frame structure, a double-layer mesh structure, or a double-layer frame structure; in this embodiment, the first supporting frame 2011 and the second supporting frame 2051 are both single-layer woven mesh structures.

The woven mesh structure or the frame structure may be a petal-shaped structure, that is, the first support skeleton 2011 and the second support skeleton 2051 are petal-shaped structures. The petal-shaped structure is composed of a plurality of supporting screw rods, the supporting screw rods are arranged along the central point of the woven net-shaped structure or the frame structure according to an annular array, and each supporting screw rod penetrates through the central point. The first and

second support backbones

2011, 2051 can be made of various biocompatible materials, i.e., each support lead can be made of various biocompatible materials, including materials commonly used in the manufacture of releasable medical devices, such as memory alloy materials, preferably nitinol; the first support skeleton 2011 and the second support skeleton 2051 may also be made of degradable materials, that is, each support lead screw is made of degradable materials, such as polylactic acid (PLA), Polycaprolactone (PCL), Polyglycolide (PGA), poly (p-dioxanone) (PDO), etc.; the supporting skeleton may also be made of a high molecular polymer material or the like.

In this embodiment, the peripheral edge of the first support frame 2011 is obliquely bent toward the second support frame 2051, and the peripheral edge of the second support frame 2051 is obliquely bent toward the first support frame 2011. Specifically, each support screw of the first support skeleton 2011 is bent obliquely towards the second support skeleton 2051 away from the geometric center of the first support skeleton 2011; each support screw of the second support skeleton 2051 is bent obliquely towards the first support skeleton 2011 away from the geometric center of the second support skeleton 2051. When the first blocking disc 201 and the second blocking disc 205 clamp tissues around the foramen ovale 200 together, the distance between the middle parts of the first blocking disc 201 and the second blocking disc 205 is larger than the distance between the peripheral edges, so that the first blocking disc 201 and the second blocking disc 205 can clamp the primary diaphragm 301 and the secondary diaphragm 303 around the foramen ovale more firmly.

As shown in fig. 2, 3 and 4, the first plugging disc 201 further includes a first steel sleeve 2015 disposed in a central region thereof, preferably, the first steel sleeve 2015 is disposed at a geometric center of the first plugging disc 201, and the support screw 2012 of the first plugging disc 201 is connected with the first steel sleeve 2015 and surrounds the first steel sleeve 2015 to form a first support skeleton 2011. First steel bushing 2015 is tubulose, and first steel bushing 2015 is provided with the through-hole that extends along the thickness direction (the direction of the first shutoff dish 201 quotation of perpendicular to) of first shutoff dish 2011, and the free end of a plurality of support screw 2012 is fixed set up in the outer peripheral face or the inner peripheral surface of first steel bushing 2015. In this embodiment, the free ends of the support screws 2012 are accommodated in the inner cavity of the first steel sleeve 2015 and are fixedly connected to the first steel sleeve 2015 by welding or bonding. The first steel sleeve 2015 is made of stainless steel, nitinol or other biocompatible materials.

The second plugging disc 205 further comprises a second steel sleeve 2055 arranged in the central region thereof, the second steel sleeve 2055 is connected with the second support skeleton 2051, and preferably, the second steel sleeve 2055 is fixedly arranged in the geometric center of the second plugging disc 205; the support screws of the second plugging disc 205 surround the second steel sleeve 2055 to form a second support skeleton 2051. The second steel sleeve 2055 is tubular, a through threading hole 2056 is formed in the second steel sleeve 2055 in the thickness direction of the second support skeleton 2051, and one end of the connecting section 23 penetrates through the threading hole 2056 to connect the knot 22. The free ends of the plurality of support screw rods are fixedly arranged on the outer peripheral surface or the inner peripheral surface of the second steel sleeve 2055. In this embodiment, the free ends of the plurality of support screws are fixedly connected to the outer peripheral surface of the second steel sleeve 2055 by welding or bonding, and the second steel sleeve 2055 is made of stainless steel, nitinol or other biocompatible materials.

In other embodiments, the first steel sleeve 2015 may also be disposed in a non-central region of the first plugging disc 201; the second steel sleeve 2055 may also be disposed in a non-central region of the second plugging disk 205.

In other embodiments, the first supporting frame 2011 and the second supporting frame 2051 are generally woven by 4-50 supporting screws, and meshes are formed between adjacent supporting screws. In the following, the first supporting skeleton 2011 is taken as an example, and the following technical solutions are also applied to the second supporting skeleton 2051: the first support skeleton 2011 in fig. 4 is formed by an annular array of 30 circular support screws 2012, the first support skeleton 2011 in fig. 5 and 6 is formed by an annular array of 6 circular support screws 2012, and the first flow blocking film 2013 is disposed on the first support skeleton 2011 in fig. 6.

In other embodiments, each of the support screws may be oval, semi-circular, prismatic, irregular, or the like. As shown in fig. 7, the first supporting skeleton 2011a is formed by a plurality of oval supporting screws 2012 annularly arrayed along a central point of the supporting skeleton 2012a, one top end of each supporting screw 2012 passes through the central point, and the inner surface and/or the outer surface of the first supporting skeleton 2011a is provided with the flow blocking film. As shown in fig. 8, the first supporting skeleton 2011b is formed by a plurality of semicircular supporting screws 2012 arranged in an annular array along a central point of the first supporting skeleton 2011b, and one of the circular arc end points of each supporting screw 2012 passes through the central point; the inner surface and/or the outer surface of the first support skeleton 2011b is provided with the flow blocking membrane. As shown in fig. 9, the first support frame 2011c is formed by a plurality of prismatic support screws 2012 arranged in a circular array along a central point of the first support frame 2011c, and one of the top ends of each support screw 2012 passes through the central point; the inner surface and/or the outer surface of the first support skeleton 2011c is provided with the flow blocking membrane. As shown in fig. 10, a first support skeleton 2011d is formed by a plurality of irregularly shaped support screws 2012 annularly arrayed along a central point of the first support skeleton 2011d, through which one of the top ends of each support screw 2012 passes; the inner surface and/or the outer surface of the first support skeleton 2011d is provided with the flow blocking membrane.

In other embodiments, each of the support screws may be triangular, polygonal, etc.

The cinch cord 21 may be a non-absorbable biocompatible suture, such as a metal wire, cotton, polyester, polypropylene, etc., the cinch cord 21 may also be an absorbable biocompatible suture, such as catgut, polyglycolide, multifilament non-biodegradable suture, etc., and the cinch cord 21 may also be a forced wound filament, etc.

Referring to fig. 2 and 3 again, the locking segment 24 and the adjusting segment 25 are respectively located at two ends of the connecting segment 23, and the knot 22 is located between the connecting segment 23 and the locking segment 24. The connecting section 23 encloses an adjusting wire loop 230 of an inverted U shape for the tightening wire 21, both ends of the adjusting wire loop 230 pass through the second blocking disk 205 to connect the knot 22, and the portion of the adjusting wire loop 230 far from the knot 22 is slidably threaded in the first blocking disk 201. Preferably, the portion of the adjusting wire ring 230 away from the knot 22 and the adjusting segment 25 is slidably inserted through the geometric center of the first blocking disk 201, and both ends of the adjusting wire ring 230 respectively penetrate through the geometric center of the second blocking disk 205 along the thickness direction of the second blocking disk 205, so as to make the forces applied to the first blocking disk 201 and the second blocking disk 205 more uniform. Specifically, the portions of the adjustment wire loop 230 remote from the knot 22 and the adjustment section 25 are threaded through the first blocking disk 201, and the two ends of the adjustment wire loop 230 are respectively threaded through the meshes of the geometric center of the second blocking disk 205, preferably, the two ends of the adjustment wire loop 230 are respectively threaded through different meshes of the second blocking disk 205, so as to facilitate connection of different components on the conveyor 50.

On first shutoff dish 201 and second shutoff dish 205, the position that regulating section 25 and locking section 24 passed is located the geometric center of first shutoff dish 201 and second shutoff dish 205, is favorable to when taut tightening line 21, and the pulling force is exerted in the geometric center of shutoff dish, and the shutoff dish atress is even, conveniently controls.

Preferably, the plurality of locations on the first plugging disc 201 where the connecting segments 23 are connected are close to each other, and/or the plurality of locations on the second plugging disc 205 where the connecting segments 23 are connected are close to each other; specifically, the positions of the two meshes of the connecting section 23 passing through the first plugging disc 201 are close to each other; on the second plugging disc 205, one end of the connecting section 23 is inserted into the threading hole 2056 of the second steel sleeve 2055, and the mesh hole through which the other end of the connecting section 23 passes is close to the threading hole 2056.

If the position span of the two ends of the connecting section 23 passing through the flow-blocking films on the first blocking disk 201 or the second blocking disk 205 is large, the through holes on the flow-blocking films for passing through the connecting section 23 are easily obliquely pulled by the connecting section 23 to cause the through holes to be larger and larger, so that the flow-blocking effect of the flow-blocking films is influenced; if the perforation of the connecting section 23 is too large, the perforation will not be endothelialized later on, resulting in a poor sealing effect of the foramen ovale. Therefore, the connecting section 23 is gathered at the position of the through holes on the two discs, the phenomenon that the through holes on the flow resisting membrane are drawn by the connecting section 23 to cause larger and larger through holes is avoided, the integrity of the flow resisting membrane is kept for a long time, and the condition that the damaged primary diaphragm 301 and the damaged secondary diaphragm 303 climb to the surface of the occluder after the operation is ensured, so that endothelialization is completed.

One end of the adjustment wire loop 230 is connected to the knot 22 and the other end of the adjustment wire loop 230 is threaded into the knot 22 and connected to the adjustment segment 25. When the knot 22 is not tightened, the adjusting section 25 can drive one end of the adjusting wire loop 230 connected with the adjusting section to slide in the knot 22 so as to adjust the length of the adjusting wire loop 230 between the first blocking disc 201 and the second blocking disc 205; the locking segment 24 serves to tension the knot 22 so that the knot 22 tightens a portion of the adjustment wire loop 230 located therein to fix the length of the adjustment wire loop 230 between the first 201 and second 205 closure discs.

As shown in fig. 3, the knot 22 comprises a base wire loop 221 and a locking wire loop 223 which are connected with each other, one end of the adjusting wire loop 230 is connected with the base wire loop 221, and the other end of the adjusting wire loop 230 passes through the locking wire loop 223 to be connected with the adjusting segment 25; when the basic wire loop 221 and the locking wire loop 223 are not tensioned, the adjusting section 25 can drive one end of the adjusting wire loop 230 connected with the adjusting section to slide in the locking wire loop 223 so as to adjust the length of the adjusting wire loop 230 between the first blocking disc 201 and the second blocking disc 205; when the locking segment 24 is pulled, the locking loop 223 and the base loop 221 are gradually tightened in sequence, so that a part of the adjustment loop 230 is tightly locked in the locking loop 223.

The tightening wire 21 includes a first section 211 (shown in fig. 11) connected to the locking section 24, and a second section 213 (shown in fig. 11) connected to the adjusting section 25, the first section 211 and the second section 213 being connected to each other; the base wire loop 221 is surrounded by the first section 211, and the locking wire loop 223 is formed by the remaining part of the first section 211 passing through the base wire loop 221; the second section 213 encloses an adjustment wire loop 230.

In the present invention, the following are defined: one side between first shutoff disc 201 and second shutoff disc 205 is the inboard, and one side that first shutoff disc 201 deviates from second shutoff disc 205 and one side that second shutoff disc 205 deviates from first shutoff disc 201 are the outside. The two ends of the adjustment wire loop 230 pass through the second closing disk 205 from the inner side of the second closing disk 205 to the outer side thereof, and the end of the adjustment wire loop 230 remote from the knot 22 passes through the inner side of the first closing disk 201.

Referring to fig. 11 to 15, the process of assembling the tightening wire 21 and the first plugging disk 201 and the second plugging disk 205 together is as follows:

1. as shown in fig. 11, one end of the tightening thread 21 passes through different meshes of the first plugging disc 201, such as two radially spaced meshes at the geometric center of the inner side of the first plugging disc 201, and then is folded back to the inner side of the first plugging disc 201, i.e. close to the other end of the tightening thread 21, so that the part of the tightening thread 21 away from the end is slidably threaded on the first plugging disc 201. At this time, the tightening wire 21 is formed into an inverted U shape, the first section 211 and the second section 213 of the tightening wire 21 are respectively located on both sides of the axial center line of the first plugging disc 201, the end of the first section 211 far away from the first plugging disc 201 is connected with the locking section 24, and the end of the second section 213 far away from the first plugging disc 201 is connected with the adjusting section 25.

2. As shown in fig. 12, the adjusting section 25 is passed through the threading hole 2056 of the second steel sleeve 2055 from the inner side to the outer side of the second blocking disk 205, the locking section 24 is passed through the mesh hole between the support frames adjacent to the second steel sleeve 2055 from the inner side to the outer side of the second blocking disk 205, the free ends of the adjusting section 25 and the locking section 24 are juxtaposed on the outer side of the second blocking disk 205, and the part of the tightening wire 21 between the first blocking disk 201 and the second blocking disk 205 forms the adjusting wire ring 230.

3. As shown in fig. 13-15, the tightening wire 21 is provided with a knot 22 formed by winding the first section 211 and the second section 213 outside the second blocking disk 205, and the knot 22 can lock and abut the locking section 24 and the adjusting section 25 outside the second blocking disk 205 to position the length of the adjusting wire loop 230. In the present embodiment, the knotting method of the knot 22 formed by winding the first section 211 is specifically described as follows:

A. the first segment is wound into a coil as shown in fig. 13 to obtain a base wire loop 221; specifically, two parts of the first section of the tightening wire 21 are overlapped to form a wire enclosure, so as to obtain the basic wire loop 221;

B. the remaining part of the first section is pulled out of the base wire loop 221 as shown in fig. 14 to obtain the locking wire loop 223. The remaining portion of the first section is connected to the locking segment 24, the remaining portion of the first section is wound from one side (for example, the side facing outward from the paper surface in fig. 14) of the base wire loop 221 to the other side (for example, the side facing inward from the paper surface in fig. 14) of the base wire loop 221, and then is threaded out from the other side of the base wire loop 221 to the one side of the base wire loop, so that the locking wire loop 223 is formed in a U shape, and the locking segment 24 is held outside the base wire loop 221;

C. the tightening member 21 is obtained by passing the adjustment segment 25 through the locking wire loop 223 as shown in figure 15, so that the second section forms an adjustment coil 230 between the first 201 and second 205 closure discs of the occluding device.

The occluding system 100 of the present invention is used in conjunction with a guide wire, a transporter 50, a dilator, etc. during use. The operation process is as follows:

1. placing the guide wire into the left superior pulmonary vein, reserving the guide wire, placing the delivery sheath and the dilator into the middle part of the left atrium, and withdrawing the dilator and the guide wire;

2. keeping the conveying sheath pipe still, inserting the conveying rod of the conveyor 50 loaded with the first blocking disc 201 and the second blocking disc 205 into the rear end of the conveying sheath pipe, then pushing the conveyor forwards, and firstly pushing the front end of the conveying rod out of the conveying sheath pipe;

3. releasing the first occluding disk 201 relatively far from the delivery device 50 in the left atrium until the first occluding disk 201 is deployed in the left atrium; the delivery sheath is then withdrawn with the transporter 50, releasing the second occluding disk 205 as the delivery sheath is withdrawn into the right atrium until the second occluding disk 205 is deployed in the right atrium; at this time, the knot 22 is in a loose state, the base wire loop 221, the locking wire loop 223, and the adjustment wire loop 230 are in a loose state, and the respective wire loops are not tightened.

4. The free end of the adjusting section 25 is pulled towards the proximal end by the conveyor 50, so that the length of the adjusting wire loop 230 is reduced, thereby shortening the length of the tightening wire 21 between the first blocking disk 201 and the second blocking disk 205, and driving the first blocking disk 201 and the second blocking disk 205 to move relative to the atrial septum until the inner side of the first blocking disk 201 is attached to one side of the atrial septum around the foramen ovale 200 and the inner side of the second blocking disk 205 is attached to the other side of the atrial septum around the foramen ovale 200;

5. when the atrial septum around the foramen ovale 200 is firmly clamped by the first and second plugging

discs

201, 205, the conveyor 50 pulls the free end of the locking segment 24 to gradually tighten the locking loop 223, the tightening loop 223 drives the foundation loop 221 to also lock, finally, the locking loop 223 and the foundation loop 221 are both tightened, so that the end of the adjusting loop 230 connected with the adjusting segment 25 is tightly locked by the locking loop 223 and fixed between the locking loop 223 and the foundation loop 221, namely, the foundation loop 221 and the locking loop 223 jointly lock the adjusting loop 230, the length dimension of the adjusting loop 230 between the first and second plugging

discs

201, 205 is fixed, and the first and second plugging

discs

201, 205 clamp the atrial septum.

6. After knotting is completed, the thread cutter is pushed to the right atrium through the conveying sheath tube, a suture is cut at a position 3-5 mm away from the thread end, the conveying sheath tube and the thread cutter are withdrawn, and the oval hole 200 is plugged.

Referring to fig. 16, the structure of the occluder according to the second embodiment of the present invention after release is similar to that of the first embodiment, except that: the knot 22a of the tightening wire 21a of the occluder in the second embodiment has a slightly different structure from the knot 22 in the first embodiment, and a reinforcing wire loop 226 is added to the knot 22 in the first embodiment of the knot 22 a. One end of the reinforcing wire loop 226 is connected to the base wire loop 221, and the other end of the reinforcing wire loop 226 passes through the gap between the base wire loop 221 and the locking wire loop 223 to connect the adjusting wire loop 230. After tightening the locking segment 24, the base loop 221 and the locking loop 223 tighten the two ends of the strengthening loop 226 in addition to the tightening of the adjusting segment 25 by the locking loop 223 during tightening of the base loop 221 and the locking loop 223, thereby strengthening the ability of the locking loop 223 to lock the adjusting segment 25.

As shown in fig. 17 to 19, the knotting method of the knot 22a is similar to that of the knot 22, and is as follows:

1. as shown in fig. 17, both ends of the first section of the tightening wire 21 are overlapped to enclose a wire enclosure, resulting in a base wire loop 221;

2. the remaining portion of the first segment after surrounding the base wire loop 221 as shown in fig. 18 is pulled out of the base wire loop 221 to obtain a U-shaped locking wire loop 223;

3. the adjustment segment 25 is passed through the gap between the base wire loop 221 and the locking wire loop 223 in a first direction as shown in fig. 19, resulting in a reinforcement wire loop 226;

4. the adjusting segments 25 are passed through the locking wire loop 223 in a second direction opposite to the first direction as shown in fig. 20, so that the portion of the takeup wire 21 between the base wire loop 221 and the locking wire loop 223 is enclosed as the adjusting coil 230, thereby obtaining the takeup member 21 a.

The base loop 221 of the tightener 21a partially overlaps the locking loop 223, and the orientation of the first direction and the second direction may be one of the following:

1. the first direction is a direction from the side of the lock wire loop 223 toward the side of the base wire loop 221, such as inward from the vertical plane of the paper in fig. 19.

2. The first direction is a direction from the side of the base wire loop 221 toward the side of the lock wire loop 223, such as outward from the vertical plane of the paper in fig. 19.

The method of assembling the tightening thread 21a with the first plugging disc 201 and the second plugging disc 205 in the second embodiment is similar to the first embodiment, i.e. before the knot 22a is knotted, one end of the tightening thread 21a passes through the mesh of the first plugging disc 201, and then is folded back to the other end of the first plugging disc 201 close to the tightening thread 21a at the inner side, so that the tightening thread 21a is located at the inner side of the first plugging disc 201; then, one end part of the tightening wire 21a passes through the threading hole 2056 of the second steel sleeve 2055 from the inner side to the outer side of the second blocking disc 205, the other end part of the tightening wire 21a passes through the mesh hole close to the second steel sleeve 2055 from the inner side to the outer side of the second blocking disc 205, so that the two ends of the tightening wire 21a are arranged at the outer side of the second blocking disc 205 in parallel, and the part of the tightening wire 21a between the first blocking disc 201 and the second blocking disc 205 forms the adjusting wire ring 230; and then the knotting method of the knot 22a is performed.

The use of the occlusion system of the second embodiment is the same as the use of the occlusion system of the first embodiment and will not be described here.

In other modified embodiments, the locking

segments

24 and 25 may be inserted or wound around the adjustment wire rings 230 and 223 for other times, so as not to hinder the realization of the adjustment length and the locking function.

In other modified embodiments, the knot 22 may be made in other knotting manners, that is, the knot 22 is provided on the first blocking disk 201 and the second blocking disk 205, and can adjust the length of the connecting section 23 and lock the connecting section.

In another modified embodiment, the first steel sleeve 2015 and the second steel sleeve 2055 are omitted from the first blocking disk 201 and the second blocking disk 205, and the tightening wire 21 is connected with the first blocking disk 201 and the second blocking disk 205 by passing through the meshes of the first blocking disk 201 and the second blocking disk 205.

In other variations, the first blocking disk 201 and the second blocking disk 205 may be single-layer mesh disks or double-layer mesh disks, respectively.

In other modified embodiments, a spacer is added on the basis of the first embodiment, specifically, a spacer is arranged at the geometric center position outside the second blocking disk 205, and the spacer is provided with two spaced through holes along the thickness direction of the second blocking disk 205, as shown in fig. 2, wherein one through hole corresponds to the threading hole 2056 of the second steel sleeve 2055, so as to facilitate the passing of one end of the adjusting wire ring 230; the other through hole corresponds to the other end of the adjustment wire ring 23 so that the other end of the adjustment wire ring 23 passes through. The knot 22, the locking segment 24 and the adjustment segment 25 are located on the side of the gasket facing away from the second plugging disc 205. In this embodiment, the gasket enables the outer side of the second plugging disc 205 to be stressed more uniformly, so that the clamping force between the first plugging disc 201 and the second plugging disc 205 is more uniform, and the closed plugging is more stable.

For convenience of description, the above method steps all use sequence numbers, and it should be noted that the above sequence numbers are not used to limit the context between the steps; the specific technical solutions in the above embodiments can be mutually applied without departing from the spirit of the present invention.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. An occluder for plugging a defect in a vasculature, wherein the occluder comprises:

two occlusion discs for covering the different openings of the defect; and

The tightening member includes a tightening wire, the tightening wire is used to pass through the defect and connect the two blocking discs, and the length of the tightening wire between the two blocking discs can pass through all the Adjust the free end of the tightening wire as described above.

2 . The occluder according to claim 1 , wherein the two blocking disks are a first blocking disk and a second blocking disk respectively, and the tightening wire comprises: 3 .

line knot;

a connecting segment connected with the wire knot, connected between the first blocking disk and the second blocking disk; and

The locking section and the adjusting section connected with the wire knot respectively include one of the free ends;

The locking section, the adjusting section and the wire knot are all arranged on the side of the second blocking disk away from the first blocking disk, and the length of the connecting section can be adjusted by the adjusting section .

3. The occluder according to claim 2, wherein the connecting section is connected to the geometric center of the first occluding disc, and/or the connecting section is connected to the second occluding disc the geometric center.

4. The occluder according to claim 2, wherein a plurality of positions on the first occluding disc connecting the connecting segments are close to each other, and/or the second occluding disc is connected to the The multiple locations of the connecting segments are close to each other.

5 . The occluder according to claim 2 , wherein the connecting section is an adjusting wire loop enclosed by the tightening wire, and both ends of the adjusting wire loop pass through the second occluder. 6 . The disc is connected to the wire knot, and the part of the adjusting wire loop away from the wire knot is inserted into the first blocking disc.

6 . The occluder according to claim 5 , wherein one end of the adjusting wire loop is passed through the wire knot to connect the adjusting segment; 6 .

When the wire knot is not tightened, the adjusting section can drive one end of the adjusting wire loop connected thereto to slide in the wire knot, so as to adjust the first blocking disk and the second blocking disk Adjust the length of the wire loop between;

The locking section is used to tighten the wire knot, so that the wire knot tightens a part of the adjustment wire loop located therein, and fixes the adjustment between the first blocking disk and the second blocking disk The length of the wire loop.

7. The occluder according to claim 6, characterized in that,

The wire knot includes a basic wire loop and a locking wire loop that are connected to each other, one end of the adjusting wire loop is connected to the basic wire loop, and the other end of the adjusting wire loop is connected to the adjustment section;

When the basic wire loop and the locking wire loop are not tightened, the adjusting section can drive one end of the adjusting wire loop connected thereto to slide in the locking wire loop, so as to adjust the first seal. Adjust the length of the wire loop between the blocking disc and the second blocking disc; pull the locking segment so that the locking wire loop and the basic wire loop are gradually tightened in turn, so that the adjustment wire loop is A portion is snugly locked in the locking wire loop.

8. The occluder according to claim 7, wherein the tightening wire comprises a first section connected with the locking section, and a second section connected with the adjustment section, the the first section and the second section are interconnected;

the base wire loop is surrounded by the first section, and the locking wire loop is formed by passing through the remaining part of the first section from the base wire loop;

The second section encloses the adjustment wire loop.

9. The occluder of claim 7, wherein the wire knot further comprises a reinforcing wire loop,

One end of the reinforcing wire loop is connected to the basic wire loop, and the other end of the reinforcing wire loop is connected to the adjusting wire loop through the gap between the basic wire loop and the locking wire loop.

10 . The occluder according to claim 2 , wherein the tightening thread is an absorbable biocompatible suture thread. 11 .

11. The occluder according to any one of claims 1 to 9, wherein the tightening member further comprises a fixing wire connected to the conveyor, and the conveyor connects the two seals through the fixing wire. One of the plugs is fixed to its distal end.

12. The occluder according to any one of claims 5-9, wherein the first occlusion disc comprises a first support frame and a first blocker disposed on the first support frame a membrane, the tightening wire is connected to the first support frame and/or the first blocking membrane.

13 . The occluder according to claim 12 , wherein the second occlusion disc comprises a second support frame and a second flow blocking film disposed on the second support frame, and the adjustment wire ring One end of the wire junction is connected to the wire junction through the second blocking film from the gap in the second supporting frame.

14 . The occluder according to claim 13 , wherein the second occluding disc further comprises a steel sleeve, the steel sleeve is connected to the second support frame, and the steel sleeve extends along the second supporting frame. 15 . The two supporting frames are provided with through-threading holes in the thickness direction, and the other end of the adjusting wire loop passes through the threading holes to connect the wire knots.

15 . The occluder according to claim 13 , wherein the first support frame and the second support frame are a woven mesh structure or a frame structure. 16 .

16. The occluder according to claim 15, wherein the first support frame and the second support frame are respectively a single-layer woven mesh structure, a single-layer frame structure, a double-layer mesh structure or Any of the double-layer frame structures.

17 . The occluder according to claim 13 , wherein the peripheral edge of the first support frame is inclined and bent toward the second support frame, and the peripheral edge of the second support frame is inclined towards the second support frame. 18 . A supporting frame is inclined and bent.

18 . The occluder according to claim 13 , wherein the first support frame and/or the second support frame are petal-shaped. 19 .

19. An occlusion system comprising the occluder of any one of claims 1 to 18, the system further comprising a conveyor for releasing the occluder.

20. A method for knotting a tightening member in an occluder, wherein the tightening member is made by winding and knotting a tightening wire, and the tightening wire comprises a locking section, a first A section, a second section and an adjustment section, the knotting method includes the following steps:

enclosing the first section into a coil to obtain a basic wire loop;

Passing the remainder of the first section out of the base wire loop to obtain a locking wire loop;

The tightening member is obtained by passing the adjusting section through the locking wire loop so that the second section forms an adjusting wire loop between the two occluding discs of the occluder.

21. The knotting method of the tightening member in the occluder according to claim 20, characterized in that,

In the steps of "passing the remaining part of the first section from the base wire loop to obtain a locking wire loop" and the step of "passing the adjustment section through the locking wire loop, the first section is The second section forms an adjusting wire loop between the two blocking discs of the occluder, so as to obtain between the tightening pieces", and the knotting method further includes:

Passing the adjustment section through the gap between the base wire loop and the locking wire loop along the first direction, so as to obtain the reinforced wire loop;

The step of "passing the adjusting section through the locking wire loop, so that the second section forms an adjusting wire loop between the two blocking discs of the occluder, so as to obtain the tightening member", Specifically:

passing the adjustment section through the locking wire loop in a second direction opposite to the first direction, so that the second section forms an adjustment wire loop between the two occlusion discs of the occluder , so as to obtain the tightening member.

22 . The method for knotting a tightening member in an occluder according to claim 21 , wherein the first direction is from one side of the locking wire loop to the side of the base wire loop. 23 . ; or the first direction is from one side of the base wire loop to the side of the locking wire loop.