Occlusion devices

Abstract

The present invention relates to an occluding device, comprising at least one occluding disc and a waist connected to the occluding disc, and a first flow blocking unit radially arranged on the occluding disc and / or the waist, wherein the waist comprises a second flow blocking unit arranged circumferentially. The first flow blocking unit arranged radially in the occluding device can block the blood in the axial direction of the heart defect, and the second flow blocking unit arranged circumferentially can block the blood in the radial direction of the heart defect, thereby facilitating the reduction of complications caused by residual shunt.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to an occlusion device. Background Art

[0002] Atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale, and patent ductus arteriosus (PDA) are common congenital heart defects. In recent years, occlusion devices have been widely used in the interventional treatment of congenital heart defects such as ASD and VSD, with the advantages of mild trauma, safe surgery, and definite short- and medium-term efficacy.

[0003] The treatment principle of the occluding device is as follows: the occluding device is radially contracted and loaded into a conveying device, which is then conveyed to the patient's heart defect site. The occluding device is released to block the defect site, and the blood flowing to the surface of the occluding device becomes thrombosed, and then becomes fibrous tissue. The tissue around the defect site also grows inward and crawls over it, eventually completing the endothelialization of the occluding device and the fibrous tissue inside the occluding device, thereby repairing the heart defect site. The occluding device mainly includes an occluding frame and a radially arranged flow-blocking membrane. When the occluding device is poorly attached to the wall of the defect site, it is easy to cause residual shunt and cause complications. Summary of the invention

[0004] Based on this, it is necessary to provide a closure device that can reduce residual shunt.

[0005] The present invention provides an occluding device, comprising at least one occluding disk, a waist connected to the occluding disk, and a first flow blocking unit radially arranged on the occluding disk and / or the waist, wherein the waist comprises a second flow blocking unit circumferentially arranged.

[0006] In one embodiment, the second flow blocking unit includes a first circumferential waist flow blocking membrane in a tubular shape, and the first circumferential waist flow blocking membrane is connected to the blocking disk.

[0007] In one embodiment, the waist includes a tubular waist mesh structure, and the second flow blocking unit is fixedly connected to the waist mesh structure.

[0008] In one embodiment, the first flow-blocking unit comprises a radial waist flow-blocking film, and the radial waist flow-blocking film is located on the inner side of the waist mesh structure.

[0009] In one embodiment, the second baffle unit includes a second circumferential waist baffle membrane and a third circumferential waist baffle membrane fixedly connected to the inner side of the waist mesh structure, and the second circumferential waist baffle membrane and the third circumferential waist baffle membrane are both tubular and arranged along the axial direction of the waist.

[0010] In one embodiment, the first baffle unit includes a radial waist baffle film, which is located on the inner side of the waist mesh structure, and one end of the second circumferential waist baffle film is integrally formed with the radial waist baffle film; one end of the third circumferential waist baffle film is fixedly connected to the radial waist baffle film and / or the second circumferential waist baffle film.

[0011] In one embodiment, the waist mesh structure includes a plurality of circles of intersections arranged axially, and the intersections covered by the second flow blocking unit are fixedly connected to the second flow blocking unit via sutures.

[0012] In one embodiment, the second flow blocking unit completely covers the side of the waist mesh structure and partially covers the blocking disk.

[0013] In one embodiment, the waist mesh structure includes a plurality of meshes, and the second flow blocking unit includes a blocking wire filled in the meshes.

[0014] In one embodiment, the waist mesh structure includes a plurality of braided wires, and the plurality of braided wires and the occluding wires are braided in a mutually crossed manner.

[0015] In one embodiment, the occluding thread fills all meshes of the waist mesh structure.

[0016] The first blocking unit arranged radially in the above-mentioned occlusion device can block the axial blood in the heart defect site, and the second blocking unit arranged circumferentially can block the radial blood in the heart defect site, thereby helping to reduce complications caused by residual shunt. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic structural diagram of an occlusion device according to an embodiment;

[0018] Figure 2 is a schematic diagram of a first flow blocking unit and a second flow blocking unit according to an embodiment;

[0019] Figure 3 for Figure 2 An axial cross-sectional view of the first radial waist baffle film and the first circumferential waist baffle film;

[0020] Figure 4 for Figure 2 A three-dimensional view of the first radial waist baffle film and the first circumferential waist baffle film;

[0021] Figure 5 for Figure 2 A schematic diagram of a first circumferential waist flow-blocking membrane suture fixation method;

[0022] Figure 6 It is a schematic diagram of the installation position of the first circumferential waist baffle film in another embodiment;

[0023] Figure 7 is a schematic diagram of a first flow blocking unit and a second flow blocking unit according to another embodiment;

[0024] Figure 8 is an axial cross-sectional view of a second flow-blocking unit of yet another embodiment;

[0025] Fig. 9 for Figure 8 A schematic diagram of a suture fixing method of the second flow blocking unit;

[0026] Fig.10 is a structural schematic diagram of a second flow blocking unit in yet another embodiment;

[0027] Fig.11 FIG. 4 is a schematic structural diagram of an occlusion device according to another embodiment. DETAILED DESCRIPTION

[0028] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0029] In order to more clearly describe the structure of the occlusion device, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, in the field of interventional medicine, the "distal end" refers to the end away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device perpendicular to its "axial direction", and the "axial" and "radial" of any component of the medical device are defined based on this principle.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0031] Example 1

[0032] See also Figure 1 This embodiment provides an occluding device 10, comprising two occluding discs 11 and a waist 13 connecting the two occluding discs 11. In a naturally expanded state (also a naturally extended state of the occluding device 10 without external force, the same below), the occluding disc 11 is roughly disc-shaped, the waist 13 is roughly tubular, and the radial dimension of the occluding disc 11 is greater than the radial dimension of the waist 13 (or referred to as radial width, the same below).

[0033] The two occluding discs 11 are respectively a first occluding disc 11a at the distal end and a second occluding disc 11b at the proximal end. The first occluding disc 11a includes a first disc mesh structure 111a, and the second occluding disc 11b includes a second disc mesh structure 111b. The proximal end of the first disc mesh structure 111a is connected to the distal end of the second disc mesh structure 111b through the waist 13, and the first disc mesh structure 111a and the second disc mesh structure 111b are both cross-woven by multiple braided wires 1311 to form a mesh, and then heat-set into a predetermined shape (such as a disc, a truncated cone, etc.).

[0034] The first sealing disc 11a is also provided with a first sealing head 15, which is arranged on the first disc mesh structure 111a, and the braided wires 1311 in the first disc mesh structure 111a converge at the distal end and are fixed in the first sealing head 15. The second sealing disc 11b is also provided with a first plug head 17, which is arranged on the second disc mesh structure 111b, and the braided wires 1311 in the second disc mesh structure 111b converge at the proximal end and are fixed to the distal end of the first plug head 17, and the proximal end of the first plug head 17 is a connecting end, which is used to connect with a conveying device (such as a conveying cable in the conveying device, not shown in the figure).

[0035] Specifically, the first disc mesh structure 111a includes an integrally formed first distal disc surface 1111a, a first proximal disc surface 1113a, a first ridge 1115a connecting the first proximal disc surface 1113a, and the first distal disc surface 1111a. The second disc mesh structure 111b includes an integrally formed second proximal disc surface 1113b, a second distal disc surface 1111b, and a second ridge 1115b connecting the second proximal disc surface 1113b and the second distal disc surface 1111b. It should be noted that in this embodiment, the overall shape and radial size of the first disc mesh structure 111a and the second disc mesh structure 111b are different. In other embodiments, the shape and radial size of the first disc mesh structure 111a and the second disc mesh structure 111b can be the same. The waist 13 includes a waist mesh structure 131. The waist mesh structure 131 is generally tubular, and is integrally formed with the first disc mesh structure 111a and the second disc mesh structure 111b to form a blocking body. The weaving method and weaving material of the waist mesh structure 131 are basically the same as those of the first disc mesh structure 111a and the second disc mesh structure 111b, and both include multiple circles of mesh units arranged axially, and each circle of mesh units includes meshes 1312 and intersections 1313 uniformly distributed along the circumference, the meshes 1312 are surrounded by multiple braided wires 1311, and the intersections 1313 are formed by crossing at least two braided wires 1311, and the distances between two adjacent intersections 1313 are equal, and the distances between the center points of two adjacent meshes 1312 are equal. It can be understood that in other embodiments, the weaving method and weaving material of the waist mesh structure 131 may also be different from those of the first disc mesh structure 111a and the second disc mesh structure 111b, and are designed according to actual needs.

[0036] The blocking disk 11 and / or the waist 13 are radially provided with a first flow blocking unit 133, and the waist 13 also includes a circumferentially provided second flow blocking unit 135. The first flow blocking unit 133 includes a disk flow blocking film 1333 and / or a first radial waist flow blocking film 1331, and the second flow blocking unit 135 includes a first circumferential waist flow blocking film 1351. The disk flow blocking film 1333 includes a first disk flow blocking film 1333a and / or a second disk flow blocking film 1333b. Figure 2In this embodiment, the first disc blocker 1333a is a circular sheet structure, fixedly connected between the first proximal disc surface 1113a and the first distal disc surface 1111a (that is, fixedly connected in the first disc mesh structure 111a). The size of the first disc blocker 1333a is adapted to the size of the first disc mesh structure 111a, so that when the first disc blocker 1333a is arranged in the first disc mesh structure 111a, the outer periphery of the first disc blocker 1333a abuts against the inner surface of the first ridge 1115a. The second disc blocker 1333b is a circular sheet structure, fixedly connected in the second disc mesh structure 111b, and adapted to the size of the second disc mesh structure 111b.

[0037] It should be noted that, in this embodiment, the radial dimensions of the first disc portion flow-blocking film 1333a and the second disc portion flow-blocking film 1333b are different because the radial dimensions of the first disc portion mesh structure 111a and the second disc portion mesh structure 111b are different. In other embodiments, the radial dimensions of the first disc portion flow-blocking film 1333a and the second disc portion flow-blocking film 1333b can be the same. In addition, the shapes of the first disc portion flow-blocking film 1333a and the second disc portion flow-blocking film 1333b can also be any other suitable shapes such as ellipse, and their specific shapes can be determined according to the shape of the heart defect site to be blocked, as long as they can play an effective blocking role.

[0038] In other embodiments, the first disc flow-blocking film 1333a can also be fixedly connected to the outer surface of the first distal disc surface 1111a and completely cover the first head 15, which can not only prevent the first head 15 from hooking on human tissue, but also prevent thrombus formation at the position of the first head 15. The second disc flow-blocking film 1333b can also be fixedly connected to the outer surface of the second proximal disc surface 1113b and partially cover the first plug head 17, but it should be noted that the second disc flow-blocking film 1333b cannot wrap the connection end of the first plug head 17 to prevent the first plug head 17 from being unable to connect to the delivery device.

[0039] In other embodiments, the first distal disk surface 1111a may also be an annular structure with a middle opening, and the first disk portion flow-blocking membrane 1333a is fixedly connected to the inner surface or outer surface of the first distal disk surface 1111a and completely covers the opening of the first distal disk surface 1111a. In this case, the medical device is a medical device without a distal head.

[0040] In this embodiment, the first end cap 15 is fixedly connected to the first disc baffle 1333a. In other embodiments, the second proximal disc surface 1113b may also be an annular structure with an opening in the middle, the second disc baffle 1333b is fixedly connected to the inner surface or outer surface of the second proximal disc surface 1113b, and completely covers the opening of the second proximal disc surface 1113b, and the first bolt head 17 is fixedly connected to the second disc baffle 1333b.

[0041] The first radial waist flow blocking film 1331 is radially arranged at the waist 13 and fixedly connected to the first circumferential waist flow blocking film 1351. The first radial waist flow blocking film 1331 is a circular sheet structure or an elliptical sheet structure, and its specific shape can be determined according to the shape of the heart defect site to be blocked.

[0042] This embodiment can effectively block the blood in the axial direction of the blocking device 10 by means of the radially arranged first disc blocking film 1333a, the second disc blocking film 1333b and the first radial waist blocking film 1331. In addition, since the outer periphery of the first disc blocking film 1333a abuts against the inner surface of the first ridge 1115a, and the outer periphery of the second disc blocking film 1333b abuts against the inner surface of the second ridge 1115b, it is beneficial to improve the blocking effect and reduce the probability of residual shunt after the blocking device 10 is implanted in the human body. In addition, since the first disc blocking film 1333a and the second disc blocking film 1333b are respectively located inside the first disc mesh structure 111a and the second disc mesh structure 111b, and the first radial waist blocking film 1331 is located inside the waist 13. Therefore, it can be prevented that the first blocking unit 133 falls off and becomes free in the human body, endangering human health.

[0043] The first circumferential waist baffle film 1351 is circumferentially arranged on the waist 13, and the first circumferential waist baffle film 1351 is roughly tubular and includes a proximal region, a distal region, and an intermediate region connecting the proximal region and the distal region. The radial dimensions of the intermediate region are basically the same, the radial dimensions of the proximal region gradually decrease from the proximal end to the distal end, and the radial dimensions of the distal region gradually increase from the proximal end to the distal end, and the radial dimensions of the proximal region and the radial dimensions of the distal region are both larger than the radial dimensions of the intermediate region. The first circumferential waist baffle film 1351 is fixedly connected to the inner side of the waist mesh structure 131. The size of the intermediate region is adapted to the waist mesh structure 131 and completely covers the inner side of the waist mesh structure 131, and the inner surface of the intermediate region abuts against the outer peripheral edge of the first radial waist baffle film 1331. Its distal region covers the first proximal disk surface 1113a and extends toward the first ridge 1115a, and its proximal region covers the second distal disk surface 1111b and extends toward the second ridge 1115b. Figure 3In this embodiment, the maximum radial dimension of a single side of the distal region is L1 larger than the radial dimension of a single side of the first radial waist baffle film 1331, and L1 is greater than or equal to 1 mm. Similarly, the maximum radial dimension of the proximal region is at least 1 mm larger than the radial dimension of a single side of the first radial waist baffle film 1331. However, it should be noted that the radial dimension of any single side of the distal region is less than or equal to the radial dimension of a single side of the first proximal disk surface 1113a, that is, the distal region may not extend beyond the first ridge 1115a at most in the direction of the first ridge 1115a. Similarly, the radial dimension of any single side of the proximal region is less than or equal to the radial dimension of a single side of the second distal disk surface 1111b, that is, the proximal region may not extend beyond the second ridge 1115b at most in the direction of the second ridge 1115b. When the occlusion device 10 is implanted into the heart defect, the first circumferential waist flow barrier 1351 is close to the two ends of the defect and the human tissue in the defect, which facilitates the adhesion of cells and thrombi in the blood and accelerates the crawling of endothelial cells, thereby blocking the blood and accelerating the occlusion speed. Its distal region can block the blood from flowing between the first proximal disk surface 1113a and the human tissue, and the proximal region can block the blood from flowing between the second distal disk surface 1111b and the human tissue, and its middle region can block the blood in the circumferential direction of the waist mesh structure 131. In addition, since the inner surface of the middle region of the first circumferential waist flow barrier 1351 abuts against the outer peripheral edge of the first radial waist flow barrier 1331, it is beneficial to improve the axial occlusion effect of the occlusion device 10. Since the first circumferential waist flow barrier 1351 is arranged in the waist mesh structure 131, it can prevent the first circumferential waist flow barrier 1351 from escaping from the waist mesh structure 131 and being free in the human body. In this embodiment, the above-mentioned fixed connection methods include suturing fixed connection, adhesive fixed connection, hot melt fixed connection, etc. For details, please refer to Figure 4 , Figure 5 , the method of fixing the first circumferential waist baffle film 1351 and the first radial waist baffle film 1331 is explained by taking suturing as an example: the first radial waist baffle film 1331 is placed inside the first circumferential waist baffle film 1351, and the first radial waist baffle film 1331 is flattened along the radial direction of the first circumferential waist baffle film 1351, so that the outer peripheral edge of the first radial waist baffle film 1331 abuts against the inner surface of the first circumferential waist baffle film 1351. Then, the first radial waist baffle film 1331 and the first circumferential waist baffle film 1351 are sewed and fixed by sutures 19. Next, please also refer to Figure 2, the first circumferential waist flow-blocking film 1351 and the first radial waist flow-blocking film 1331 that are fixedly connected are placed in the waist mesh structure 131, and the first circumferential waist flow-blocking film 1351 and the first radial waist flow-blocking film 1331 are arranged so that the first circumferential waist flow-blocking film 1351 is attached to the inner surface of the waist mesh structure 131. A circle of mesh units is selected from the mesh units covered by the first circumferential waist flow-blocking film 1351 as the sewing object, and a starting point is selected on the inner side of the first circumferential waist flow-blocking film 1351 (not shown). After the suture 19 is passed from the starting point to the outside of the first circumferential waist flow-blocking film 1351, it continues to pass through the first mesh 1312A of the ring mesh unit and is located on the first side of the first intersection 1313a, so that the suture 19 is circumferentially passed from the outside of the first intersection 1313a to the second side opposite to the first side to hook the first intersection 1313a, and then passed through the second side of the first intersection 1313a (i.e., the second mesh 1312B adjacent to the first mesh 1312A in the circumferential direction) to the inside of the first circumferential waist flow-blocking film 1351. Repeat this routing method until all the intersections 1313 of the ring mesh unit are fixed to the first circumferential waist flow-blocking film 1351 through the suture 19 and return to the starting point. Finally, the two ends of the suture 19 are gathered and knotted, the excess suture 19 is cut off, and the thread ends of the suture 19 are melted to 0.5mm to 1.5mm away from the knotting position using a hot melt device (such as an electric soldering iron, etc.). After completing the suturing of a circle of mesh units, if the first circumferential waist flow-blocking film 1351 also covers other mesh units, continue to sew according to the above-mentioned suturing method until all the intersections 1313 covered by the first circumferential waist flow-blocking film 1351 are fixedly connected to the first circumferential waist flow-blocking film 1351 through the suture 19. It should be noted that the restraining force of the suture 19 on the intersection 1313 should not be too large. Excessive restraining force causes the braided wire 1311 to be tightly bound at the intersection 1313 and cannot move relative to each other, which makes it difficult for the occluding device 10 to restore its original shape after being released from the conveying device. In addition, the knotted point must be on the inner side of the waist flow-blocking membrane 1351 in the first week and must not be exposed to the outside, so as to avoid thrombosis caused by the exposed knotted point.

[0044] It should be understood that in this embodiment, the first circumferential waist flow-blocking film 1351 and the first radial waist flow-blocking film 1331 are first sutured and fixed, and then placed in the waist mesh structure 131 for suture and fixation. In other embodiments, the first circumferential waist flow-blocking film 1351 can also be placed in the waist mesh structure 131 and fixed, and then the first radial waist flow-blocking film 1331 is placed in the first circumferential waist flow-blocking film 1351 and fixed. In addition, the suturing method in this embodiment is to fix the intersection 1313 and the first circumferential waist flow-blocking film 1351 through the circumferential suture line 19. In other embodiments, the intersection 1313 and the first circumferential waist flow-blocking film 1351 can also be fixed through the axial suture line 19. The present invention does not limit the specific routing direction of the suture line 19, as long as the intersection 1313 and the first circumferential waist flow-blocking film 1351 can be effectively fixed. It is understandable that in other embodiments, the suturing may be performed at intervals of one or two intersection points, that is, there may be an intersection point separated from the coating between two adjacent suturing points.

[0045] Please refer again Figure 2 The occluding device 10 further includes a first locking member (not shown), the distal end of the first locking member is fixedly connected to the first end cap 15, and the proximal end of the first locking member is detachably connected to the first bolt head 17 through interference fit. After the occluding device 10 is released, the distal end of the occluding device 10 can be gradually pulled toward the proximal end by the first locking member, so that the occluding device 10 restores the double-disc structure, and then the first locking member is connected to the first bolt head 17 through interference fit to fix the distance between the distal end and the proximal end of the occluding device 10, so that the occluding device 10 restores and maintains a stable double-disc structure again after release. It is understandable that the shape, structure and connection method of the first locking member with the first end cap 15 and the first bolt head 17 are not limited to the method provided in this embodiment, and the structure and connection method commonly used in the art can also be adopted. It is understandable that in other embodiments, the first locking member can also be omitted, as long as the medical device has a stable structure in the naturally unfolded state, such as the occluding device 10 formed by braiding and shaping nickel-titanium wire.

[0046] The first disc baffle 1333a, the second disc baffle 1333b and the first radial waist baffle 1331 are all provided with through holes (not shown), the aperture of which is adapted to the size of the first locking piece, so that the proximal end of the first locking piece can pass through the through hole and be detachably connected to the first bolt head 17. In this embodiment, the through hole is a circular hole with an aperture of 0.5 to 1 mm to ensure that the first locking piece can pass through while avoiding the opening being too large to affect the blocking effect. It can be understood that in other embodiments, the through hole is not limited to a circular hole, and can be a through hole of other shapes, such as a square hole, a bar hole, a cross slit, etc.

[0047] In this embodiment, the occlusion device 10 is an absorbable occlusion device, and the braided wire 1311 (see Figure 1 ), the first flow-blocking unit 133 and the second flow-blocking unit 135 are made of biodegradable polymer materials, and the biodegradable polymer materials are selected from at least one of L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone. Since the occluding device 10 is made of biodegradable polymer materials, it can be degraded and absorbed by the body after endothelialization is completed, so that the defect is completely repaired by the body's own tissue, thereby eliminating the long-term complications caused by the permanent retention of metal alloy occluding devices in the body. In addition, a circumferential second flow-blocking unit 135 is provided at the waist 13, which is beneficial to improving the stability of the shape of the waist 13 and enhancing the supporting force of the waist 13. It can prevent the occluding device 10 from being radially contracted and loaded into the conveying device, and then released from the conveying device. The waist 13 is changed in shape and causes poor adhesion to the defective part, thereby reducing the risk of residual shunt and complications.

[0048] In other embodiments, the braided wire 1311 may also be made of a metal material with shape memory properties such as nickel-titanium alloy, and the first flow-blocking unit 133 and the second flow-blocking unit 135 may be made of a polymer material with good biocompatibility such as PET and PTFE. The materials used for the braided wire 1311, the first flow-blocking unit 133, and the second flow-blocking unit 135 may be selected as needed.

[0049] Example 2

[0050] Reference Figure 6 The difference between this embodiment and embodiment 1 is that the first circumferential waist flow-blocking film 1351 is fixedly connected to the outside of the waist mesh structure 131. The first radial waist flow-blocking film 1331 is fixedly connected to the inside of the waist mesh structure 131. Specifically, in order to facilitate operation and improve the efficiency of fixed connection, the first radial waist flow-blocking film 1331 can be first fixed (for example, sutured) to the waist mesh structure 131, and then the first circumferential waist flow-blocking film 1351 is fixedly connected to the outside of the waist mesh structure 131.

[0051] Example 3

[0052] See also Figure 7 The difference between this embodiment and embodiment 1 is that the first flow blocking unit 133 of this embodiment omits the first radial waist flow blocking film 1331 (refer to Figure 2), and the first circumferential waist baffle film 1351 is respectively connected to the first disk baffle film 1333a and the second disk baffle film 1333b. Among them, the first circumferential waist baffle film 1351 is fixedly connected to the inner side of the waist mesh structure 131. The middle area of ​​the first circumferential waist baffle film 1351 is fixedly connected to the inner side of the waist mesh structure 131, and the size of the middle area is adapted to the waist mesh structure 131, and completely covers the waist mesh structure 131. The distal area of ​​the first circumferential waist baffle film 1351 covers the area of ​​the first proximal disk surface 1113a except the area corresponding to the waist mesh structure 131, and is fixedly connected to the first proximal disk surface 1113a, and the edge of the distal area extends to the inner side of the first ridge 1115a and is connected to the first disk baffle film 1333a. The proximal region of the first circumferential waist baffle film 1351 covers the area of ​​the second distal disk surface 1111b except the area corresponding to the waist mesh structure 131, and is fixedly connected to the second distal disk surface 1111b, and the edge of the proximal region extends to the inner side of the second ridge 1115b and is connected to the second disk baffle film 1333b.

[0053] In this embodiment, since the first disc baffle film 1333a, the second disc baffle film 1333b and the first circumferential waist baffle film 1351 are interconnected to form a closed three-dimensional structure, it is beneficial to further improve the axial and circumferential blood blocking effect on the heart defect site, and more effectively reduce complications caused by residual shunt.

[0054] Furthermore, the first disc baffle film 1333a, the second disc baffle film 1333b and the first circumferential waist baffle film 1351 in the present embodiment can also be integrally formed, so there is no need to fix the three to each other by suturing or the like, thereby avoiding deformation or separation caused by loose connection. Therefore, the three can maintain a relatively fixed position relationship to achieve a relatively stable blood blocking effect.

[0055] It can be understood that in other embodiments, the distal region of the first circumferential waist baffle film 1351 covers the area of ​​the first proximal disk surface 1113a except the area corresponding to the waist mesh structure 131, and is fixedly connected to the first proximal disk surface 1113a, and the edge of the distal region extends to the inside of the first ridge 1115a, but is not connected to the first disk baffle film 1333a. The proximal region of the first circumferential waist baffle film 1351 covers the area of ​​the second distal disk surface 1111b except the area corresponding to the waist mesh structure 131, and is fixedly connected to the second distal disk surface 1111b, and the edge of the proximal region extends to the inside of the second ridge 1115b but is not connected to the second disk baffle film 1333b.

[0056] Example 4

[0057] Reference Figure 8In this embodiment, based on the embodiment 1, the first circumferential waist flow-blocking film 1351 (refer to Figure 2 ) is replaced by a second circumferential waist baffle film 1353 and a third circumferential waist baffle film 1355. The second circumferential waist baffle film 1353 and the third circumferential waist baffle film 1355 are both tubular, and both include a first end with a smaller radial dimension and a second end with a larger radial dimension. The first end of the second circumferential waist baffle film 1353 is integrally formed with the first radial waist baffle film 1331, the second end of the second circumferential waist baffle film 1353 has an opening, and the first end and the second end of the third circumferential waist baffle film 1355 both have openings. The first end of the third circumferential waist baffle film 1355 is fixedly connected to the first end of the second circumferential waist baffle film 1353, and / or the first end of the third circumferential waist baffle film 1355 is fixedly connected to the first radial waist baffle film 1331.

[0058] Please also see Figure 1 The second circumferential waist flow-blocking film 1353 and the third circumferential waist flow-blocking film 1355 of this embodiment completely cover the waist mesh structure 131, and the second end of the second circumferential waist flow-blocking film 1353 extends in the direction of the first ridge 1115a but cannot exceed the first ridge 1115a, and its single-side radial dimension is at least 1 mm larger than the single-side radial dimension of the first radial waist flow-blocking film 1331. The second end of the third circumferential waist flow-blocking film 1355 extends in the direction of the second ridge 1115b but cannot exceed the second ridge 1115b, and its single-side radial dimension is at least 1 mm larger than the single-side radial dimension of the first radial waist flow-blocking film 1331.

[0059] For details, please also refer to Fig. 9, the fixing method of the first radial waist flow-blocking film 1331, the second circumferential waist flow-blocking film 1353, and the third circumferential waist flow-blocking film 1355 is specifically described by taking the method of suturing and fixing as an example: the second circumferential waist flow-blocking film 1353 and the first radial waist flow-blocking film 1331 formed in one piece are placed inside the waist mesh structure 131, and the second circumferential waist flow-blocking film 1353 is fitted with the inner surface of the waist mesh structure 131, and the first radial waist flow-blocking film 1331 is flush with a circle of intersection points 1313 in the waist mesh structure 131. Then, referring to the suturing method in Example 2, except for the circle of intersection points 1313 flush with the first radial waist flow-blocking film 1331, the remaining intersection points 1313 covered by the second circumferential waist flow-blocking film 1353 are fixedly connected to the second circumferential waist flow-blocking film 1353 through the suture line 19. Next, the second intersection 1313b is selected as the starting intersection from the circle intersection 1313 flush with the first radial waist flow-blocking film 1331, and the suture 19 is passed from the inner side of the second circumferential waist flow-blocking film 1353 to the outer side of the second circumferential waist flow-blocking film 1353, and then the suture 19 is passed from the third mesh 1312C on the first side of the second intersection 1313b, so that the suture 19 is passed from the outer side of the second intersection 1313b to the second side opposite to the first side of the second intersection 1313b to hook the second intersection 1313b. Then, the suture 19 is passed from the second side of the second intersection 1313b (i.e., the fourth mesh 1312D adjacent to the third mesh 1312C in the circumferential direction) to the inner side of the third circumferential waist flow-blocking film 1355, and then the suture 19 is passed through the first radial waist flow-blocking film 1331 to the inner side of the second circumferential waist flow-blocking film 1353. Repeat this routing method until the intersection points 1313 of the circle are fixed to the second circumferential waist flow-blocking film 1353, the third circumferential waist flow-blocking film 1355 and the first radial waist flow-blocking film 1331 through the sutures 19, and then the two ends of the sutures 19 are gathered and knotted. Finally, referring to the suture method in Example 2, the remaining intersection points 1313 covered by the third circumferential waist flow-blocking film 1355 are fixedly connected to the third circumferential waist flow-blocking film 1355 through the sutures 19.

[0060] In another embodiment, the third circumferential waist baffle film 1355 can be first fixed with the integrally formed second circumferential waist baffle film 1353 and the first radial waist baffle film 1331 through sutures 19 and then placed together in the waist mesh structure 131, and referring to the suturing method in Example 2, the intersection points 1313 covered by the second circumferential waist baffle film 1353 are fixedly connected to the second circumferential waist baffle film 1353 through sutures 19, and the intersection points 1313 covered by the third circumferential waist baffle film 1355 are fixedly connected to the third circumferential waist baffle film 1355 through sutures 19.

[0061] Compared with Example 1, the first radial waist baffle film 1331 and the second circumferential waist baffle film 1353 of this embodiment are integrally formed, which not only reduces the difficulty of suturing, but also improves the axial blocking effect.

[0062] The occluding devices 10 of the above-mentioned embodiments 1 to 4 all include a waist mesh structure 131. It is understandable that in other embodiments, the waist 13 may omit the waist mesh structure 131. When the waist mesh structure 131 is not included, the two ends of the second flow blocking unit 135 are respectively connected to the first occluding disk 11a and the second occluding disk 11b, and the second flow blocking unit 135 can play the role of the waist.

[0063] Example 5

[0064] The difference between this embodiment and embodiment 1 is that, referring to Figure 2 , Fig.10 The second flow-blocking unit 135 of this embodiment omits the first circumferential waist flow-blocking film 1351, and includes a blocking line 1357, which is filled in the plurality of meshes 1312 of the waist mesh structure 131, and the first radial waist flow-blocking film 1331 is fixedly connected to the inner side of the waist mesh structure 131. It should be noted that the "filling" of a certain mesh 1312 in this embodiment is not limited to filling the mesh 1312 completely ("filling" means that there is no gap in the mesh 1312), and the mesh 1312 can also be partially filled (that is, gaps are allowed in the mesh 1312).

[0065] In this embodiment, the blocking wire 1357 and the plurality of braided wires 1311 of the waist mesh structure 131 are woven in a mutually intersecting manner. Fig. 9 The waist mesh structure 131 is woven from woven materials in two weaving directions (a first weaving direction and a second weaving direction). Each weaving direction is composed of 9 braided wires 1311 with a diameter of 0.1 mm, and each mesh 1312 woven from the braided wires 1311 is filled with 2 strands of blocking wire 1357 (the specification of each strand of blocking wire 1357 is 90D / 72F, and the meaning of 90D / 72F is that each strand of blocking wire 1357 contains 72 fiber strands, and the total mass of these 72 fiber strands is 90 deniers). Specifically, a needle is used to guide the blocking wire 1357 in the waist mesh structure 131 (see Figure 1 ) so that the blocking line 1357 is woven in two directions in an alternating manner (twill weaving). After the weaving is completed, the two ends of the blocking line 1357 can be knotted on the inner side of the waist mesh structure 131.

[0066] In other embodiments, the number of strands of the blocking wire 1357 filled in the mesh 1312 formed by the braided wire 1311, the size of the braided wire 1311, and the specifications of the blocking wire 1357 are not limited to the above-mentioned sizes and specifications, and can be selected according to the actual application scenario. In addition, the weaving method of the blocking wire 1357 is not limited to twill weaving, and can also be any applicable weaving method such as plain weaving.

[0067] The above-mentioned blocking line 1357 is formed by a plurality of fiber lines (such as fiber lines made of degradable polymer materials), and there are gaps between the fiber lines. Therefore, the blocking line 1357 is relatively fluffy as a whole and has a strong adsorption capacity. It can adsorb cells and thrombi in the blood, thereby forming thrombi on the surface of the fiber line to reduce the gaps between the fibers, thereby forming a relatively dense structure, which can achieve blocking more quickly. Therefore, the circumferential flow-blocking membrane can be omitted, which is beneficial to reducing the size of the waist 13 after radial contraction. In addition, the fiber line is relatively soft and can reduce the wear on the tissue. Preferably, please also refer to Figure 1 In this embodiment, the blocking line 1357 fills all the meshes 1312 of the waist mesh structure 131, and can partially fill the meshes 1312 in the first proximal disk surface 1113a and the second distal disk surface 1111b to further improve the circumferential blocking effect of the waist 13.

[0068] It can be understood that, in other embodiments, the second flow-blocking unit 135 includes both the first circumferential waist flow-blocking film 1351 and the blocking line 1357. For example, the first circumferential waist flow-blocking film 1351 partially covers the side of the waist mesh structure 131, and the meshes 1312 in the waist mesh structure 131 that are not covered by the first circumferential waist flow-blocking film 1351 are filled with the blocking line 1357. For another example, the first circumferential waist flow-blocking film 1351 completely covers the side of the waist mesh structure 131, and the meshes 1312 of the waist mesh structure 131 are also filled with the blocking line 1357.

[0069] Understandably, see Figure 1 In other embodiments, the blocking line 1357 may be filled in the first disc mesh structure 111a and / or the second disc mesh structure 111b to replace the first disc block film 1333a and / or the second disc block film 1333b to achieve the blocking effect.

[0070] Example 6

[0071] See also Fig.11The difference between this embodiment and embodiments 1 to 5 is that the occluding device 20 of this embodiment only includes a third occluding disk 21 and a waist 23 connected to the third occluding disk 21. In the naturally expanded state, the radial dimension of the third occluding disk 21 is larger than the radial dimension of the waist 23. The structure of the third occluding disk 21 in this embodiment is similar to the first occluding disk 11a in embodiments 1 to 5 (see Figure 1 ) has a substantially similar structure, including a third disc mesh structure 211 and a third disc flow-blocking film 213. The third disc mesh structure 211 includes an integrally formed third proximal disc surface 2113, a third distal disc surface 2111, and a third ridge 2115 connecting the third proximal disc surface 2113 and the third distal disc surface 2111. The third disc flow-blocking film 213 is a circular sheet structure, fixedly connected between the third proximal disc surface 2113 and the third distal disc surface 2111, and adapted to the size of the third disc mesh structure 211.

[0072] The waist portion 23 comprises a waist mesh structure 231. The waist mesh structure 231 is closed at its proximal end, is generally tubular, and is integrally formed with the third disc mesh structure 211 at its distal end.

[0073] The blocking device 20 also includes a first flow-blocking unit 233 arranged radially and a second flow-blocking unit 235 arranged circumferentially. The first flow-blocking unit 233 includes a third disc flow-blocking film 2331, a second radial waist flow-blocking film 2332, and a third radial waist flow-blocking film 2333 arranged axially spaced from the distal end to the proximal end. The second flow-blocking unit 235 includes a fourth circumferential waist flow-blocking film 2351. The third disc flow-blocking film 2331, the second radial waist flow-blocking film 2332, and the third radial waist flow-blocking film 2333 are all circular sheet structures (or elliptical sheet structures, etc.). The edge of the third disc flow-blocking film 2331 abuts against the third ridge 2115, and the second radial waist flow-blocking film 2332 and the third radial waist flow-blocking film 2333 abut against the inner surface of the waist mesh structure 231. The third radial waist flow-blocking film 2333 is fixedly connected to the waist mesh structure 231. The second radial waist flow-blocking film 2332 is integrally formed with the fourth circumferential waist flow-blocking film 2351, which is generally tubular and fixedly connected to the inner side of the waist mesh structure 231, and its radial dimension gradually increases from the proximal end to the distal end, and its distal edge covers part of the third proximal disk surface 2113 and extends in the direction of the third ridge 2115 but does not exceed the third ridge 2115 at most. In this embodiment, the maximum single-side radial dimension of the fourth circumferential waist flow-blocking film 2351 is L2 larger than the single-side radial dimension of the second radial waist flow-blocking film 2332, and L2 is greater than or equal to 1 mm.

[0074] The third occluding disc 21 is provided with a second end cap 25 at the distal end, and a second plug head 27 at the proximal end of the waist 23. The occluding device 20 also includes a second locking member (not shown), the distal end of the second locking member is fixedly connected to the second end cap 25, and the proximal end of the second locking member is detachably connected to the second plug head 27 through interference fit. It can be understood that in other embodiments, the second locking member can also be omitted, as long as the structure of the medical device is stable in the naturally unfolded state, such as the occluding device 20 formed by braiding and shaping nickel-titanium wire.

[0075] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0076] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An occluding device, comprising at least one occluding disk, a waist connected to the occluding disk, and a first flow blocking unit, wherein the first flow blocking unit is radially arranged on the waist, or radially arranged on the waist and the occluding disk, characterized in that: The sealing disk includes two disk surfaces arranged axially along the sealing disk, and a ridge connecting the two disk surfaces, the waist includes a tubular waist mesh structure, the first flow blocking unit includes a radial waist flow blocking membrane, the radial waist flow blocking membrane is located on the inner side of the waist mesh structure, the waist includes a circumferentially arranged second flow blocking unit, the second flow blocking unit completely covers the waist, and at least one axial end of the second flow blocking unit extends toward the ridge of the sealing disk to partially cover the sealing disk.

2. The occlusion device according to claim 1, characterized in that: The occluding device includes a first occluding disk located at the distal end of the waist and a second occluding disk located at the proximal end of the waist, the first occluding disk includes a first disk mesh structure, the second occluding disk includes a second disk mesh structure, the first disk mesh structure includes an integrally formed first distal disk surface, a first proximal disk surface, and a first ridge connecting the first proximal disk surface and the first distal disk surface, the second disk mesh structure includes an integrally formed second proximal disk surface, a second distal disk surface, and a second ridge connecting the second proximal disk surface and the second distal disk surface, the second flow blocking unit includes a tubular first circumferential waist flow blocking membrane, the first circumferential waist flow blocking membrane is connected to the occluding disk, the first circumferential waist flow blocking membrane includes a proximal area, a distal area and an intermediate area connecting the proximal area and the distal area, the distal area covers the first proximal disk surface and extends in the direction of the first ridge, and its proximal area covers the second distal disk surface and extends in the direction of the second ridge.

3. The occlusion device according to claim 2, characterized in that: The second flow-blocking unit is fixedly connected to the waist mesh structure, the radial dimension of the proximal region gradually decreases from the proximal end to the distal end, the radial dimension of the distal region gradually increases from the proximal end to the distal end, and the radial dimension of the proximal region and the radial dimension of the distal region are both larger than the radial dimension of the middle region, the radial dimension of any single side of the distal region is smaller than the radial dimension of any single side of the first proximal disk surface, and the radial dimension of any single side of the proximal region is smaller than the radial dimension of any single side of the second distal disk surface.

4. The occlusion device according to claim 1, characterized in that: The occluding device is an absorbable occluding device, and the braided wire, the first flow-blocking unit and the second flow-blocking unit of the occluding device are all made of degradable polymer materials, and the degradable polymer materials are selected from at least one of L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoic acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone.

5. The occlusion device according to claim 1, characterized in that: The second baffle unit includes a second circumferential waist baffle membrane and a third circumferential waist baffle membrane fixedly connected to the inner side of the waist mesh structure. The second circumferential waist baffle membrane and the third circumferential waist baffle membrane are both tubular and arranged along the axial direction of the waist.

6. The occlusion device according to claim 5, characterized in that: The first baffle unit includes a radial waist baffle film, which is located on the inner side of the waist mesh structure, and one end of the second circumferential waist baffle film is integrally formed with the radial waist baffle film; one end of the third circumferential waist baffle film is fixedly connected to the radial waist baffle film and / or the second circumferential waist baffle film.

7. The occlusion device according to any one of claims 1 to 6, characterized in that: The waist mesh structure includes a plurality of cross points arranged axially, and the cross points covered by the second flow blocking unit are fixedly connected to the second flow blocking unit via sutures.

8. The occlusion device according to any one of claims 1 to 6, characterized in that: The second flow-blocking unit completely covers the side surface of the waist mesh structure.

9. The occlusion device according to any one of claims 1 to 6, characterized in that: The waist mesh structure includes meshes, and the second flow blocking unit includes a blocking line filled in the meshes.

10. The occlusion device according to claim 9, characterized in that: The waist mesh structure includes a plurality of braided wires, and the plurality of braided wires and the blocking wires are braided in a mutually intersecting manner.

11. The occlusion device according to claim 9, characterized in that: The blocking wire fills all the mesh holes of the waist mesh structure.

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