Occluder

Abstract

The present invention relates to an occluder, comprising an occluding unit and a sealing head connected to the occluding unit, wherein the occluding unit has a central axis, the central axis passes through the distal end and the proximal end of the occluder, the occluder also comprises a marking structure, the marking structure comprises a distal marker and at least two first markers, the distal marker is arranged on the sealing head, each first marker is connected to the occluding unit, each first marker is located in the same placement plane, the placement plane is perpendicular to the central axis, the distal marker is located outside the placement plane, the projection point of each first marker in a projection plane perpendicular to the placement plane is located on a straight line segment, and in the natural state of the occluder, the line connecting the distal marker and the two end points of the straight line segment is a triangle. The occluder of the present invention can improve the success rate of implantation surgery.

Description

Technical Field

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

[0002] In 1974, King and Mills first completed the transcatheter interventional treatment of secundum atrial septal defect (ASD). Since then, with the continuous improvement of occlusion devices, especially since 1997, with the launch of Amplatzer nickel-titanium alloy braided occluder, nickel-titanium alloy braided occluder has been widely used in the interventional treatment of congenital heart diseases such as atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA) and patent foramen ovale (PFO). At present, transcatheter interventional occluder has become an important method for minimally invasive treatment of congenital heart diseases such as atrial septal defect ASD, VSD, PDA and PFO. After the occluder is inserted into the heart defect site, the tissue around the defect grows inward and completes endothelialization. Non-degradable occluders still exist in the defect site for a long time after endothelialization, which is prone to long-term complications and adverse effects, including atrioventricular conduction block, valve damage, residual shunt, heart wear, nickel allergy, etc. Therefore, degradable occluders made of degradable materials are the latest development direction in the field of interventional therapy. After being implanted in the human body, degradable occluders can complete the effect of blocking defects. After the blocking is completed, the materials that make up the occluder degrade in the body and are eventually metabolized into CO2 and water and excreted from the body, preventing the human body from being affected by foreign bodies for a long time.

[0003] Biodegradable materials used in the field of interventional therapy include, but are not limited to, polylactic acid (PLA), polyglycolic acid (PGA), polylactic-co-glycolic acid (PLGA), polyhydroxyalkanoates (PHA), polydioxanone (PDO) or polycaprolactone (PCL).

[0004] Interventional occlusion usually requires surgery under the guidance of X-ray imaging equipment such as DSA (Digital Subtraction Angiography), so the occluder is required to be radiopaque under X-rays so that it can be identified under X-rays. Occluders made of degradable materials have poor visualization under X-rays, and it is difficult to determine their exact position and release state under DSA, resulting in a reduced success rate of implantation surgery. Summary of the invention

[0005] Based on this, it is necessary to provide an occluder to solve the problem that it is difficult to determine the exact position and release state of the implanted product under X-ray imaging equipment with existing occluders.

[0006] An occluder includes an occluding unit and a head connected to the occluding unit, the occluding unit having a central axis, the central axis passing through the distal end and the proximal end of the occluder, the occluder also including a marking structure, the marking structure including a distal marker and at least two first markers, the distal marker is arranged on the head, each first marker is connected to the occluding unit, each first marker is located in the same placement plane, the placement plane is perpendicular to the central axis, the distal marker is located outside the placement plane, the projection point of each first marker in a projection plane perpendicular to the placement plane is located on a straight line segment, and in the natural state of the occluder, the line connecting the distal marker and the two end points of the straight line segment forms a triangle.

[0007] It can be understood that the blocking unit includes a first subunit, the first subunit includes a first mesh disk and a first flow-blocking membrane arranged in the first mesh disk, the central axis passes through the geometric center of the first mesh disk, and the central axis is perpendicular to the plane where the first mesh disk is located, the central axis passes through the geometric center of the first flow-blocking membrane, and the central axis is perpendicular to the plane where the first flow-blocking membrane is located, each first marker is connected to the first mesh disk, or each first marker is connected to the first flow-blocking membrane.

[0008] It can be understood that each first marker is fixed on the first mesh disk, and in the natural state of the occluder, the distance between each first marker and the central axis is equal to or less than the distance from the edge of the first mesh disk to the geometric center of the first mesh disk.

[0009] It can be understood that each first marker is fixed on the first flow-blocking membrane, and in the natural state of the occluder, the distance between at least one of the first markers and the central axis is equal to the distance from the edge of the first flow-blocking membrane to the geometric center of the first flow-blocking membrane, or the distance between each first marker and the central axis is smaller than the distance from the edge of the first flow-blocking membrane to the geometric center of the first flow-blocking membrane.

[0010] It can be understood that in the natural state of the occluder, the distance between each first marker and the central axis is smaller than the distance from the edge of the first baffle film to the geometric center of the first baffle film, and each first marker is distributed along the first circumference, and the first circumference is concentrically arranged with the first baffle film.

[0011] It can be understood that the first markers are distributed at equal intervals along the first circumference, and the number of the first markers ranges from 2 to 12.

[0012] It can be understood that the blocking unit also includes a second subunit connected to the first subunit, the second subunit includes a second mesh disk and a second flow-blocking membrane arranged in the second mesh disk, the central axis passes through the geometric center of the second mesh disk, and the central axis is perpendicular to the plane where the second mesh disk is located, the central axis passes through the geometric center of the second flow-blocking membrane, and the central axis is perpendicular to the plane where the second flow-blocking membrane is located, and the marking structure also includes at least two second markers, each second marker is connected to the second mesh disk, or each second marker is connected to the second flow-blocking membrane.

[0013] It can be understood that each second marker is fixed on the second mesh disk, and in the natural state of the occluder, the distance between each second marker and the central axis is equal to or less than the distance from the edge of the second mesh disk to the geometric center of the second mesh disk.

[0014] It can be understood that each second marker is fixed on the second flow-blocking membrane, and in the natural state of the occluder, the distance between at least one of the second markers and the central axis is equal to the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane, or the distance between each second marker and the central axis is smaller than the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane.

[0015] It can be understood that in the natural state of the occluder, the distance between each second marker and the central axis is smaller than the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane, and each second marker is distributed along the second circumference, which is concentrically arranged with the second flow-blocking membrane.

[0016] It can be understood that the second markers are distributed at equal intervals along the second circumference, and the number of second markers ranges from 2 to twelve.

[0017] It can be understood that the blocking unit also includes a waist and a third baffle membrane, the two ends of the waist are respectively connected to the first mesh disk and the second mesh disk, the third baffle membrane is arranged in the waist, the central axis passes through the geometric center of the third baffle membrane, and the central axis is perpendicular to the plane where the third baffle membrane is located, and the marking structure also includes at least two third markers, each third marker is connected to the waist, or each third marker is connected to the third baffle membrane.

[0018] It can be understood that each third marker is connected to the third flow-blocking membrane. In the natural state of the occluder, the distance between at least one of the third markers and the central axis is equal to the distance from the edge of the third flow-blocking membrane to the geometric center of the third flow-blocking membrane, or the distance between each third marker and the central axis is less than the distance from the edge of the third flow-blocking membrane to the geometric center of the third flow-blocking membrane.

[0019] It can be understood that the number of the first marker, the second marker and the third marker are all 2. In the natural state of the occluder, the two first markers are located at both ends of the same diameter of the first baffle membrane, the two second markers are located at both ends of the same diameter of the second baffle membrane, and the two third markers are located at both ends of the same diameter of the third baffle membrane, and the two first markers, the two second markers and the two third markers are coplanar.

[0020] The marking structure of the above-mentioned occluder includes a distal marker and at least two first markers. The distal marker is arranged on the head, and each first marker is connected to the occluding unit. Each first marker is located in the same placement plane, and the placement plane is perpendicular to the central axis. The distal marker is arranged outside the placement plane. The projection point of each first marker in a projection plane perpendicular to the placement plane is located on a straight line segment. In the natural state of the occluder, the line connecting the two end points of the distal marker and the straight line segment is a triangle. During the release process of the occluder, the marking structure can be developed under DSA to guide the release of the occluder. During the operation, the exact position and release state of the occluding unit can be accurately judged by the morphological changes of the triangle formed by the line connecting the two end points of the distal marker and the straight line segment, thereby improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 FIG. 4 is a schematic diagram of the structure of an occluder in an embodiment.

[0022] Figure 2 It is a schematic diagram of the structure of the occluder cooperating with the atrial septum in one embodiment.

[0023] Figure 3 Schematic diagram of the structure of the occluder and the sheath in one embodiment.

[0024] Figure 4a FIG. 4 is a diagram showing a first state of an occluder in an embodiment.

[0025] Figure 4b FIG. 4 is a diagram showing a second state of the occluder in one embodiment.

[0026] Figure 4c FIG. 4 is a diagram showing a third state of the occluder in one embodiment.

[0027] Figure 4d FIG. 4 is a diagram of a fourth state of an occluder in an embodiment.

[0028] Figure 5 Schematic diagram of the structure of the first flow-blocking film and the first marker in one embodiment.

[0029] Figure 6 It is a structural schematic diagram of a head, a plugging unit, and a marking structure in one embodiment.

[0030] Figure 7FIG. 4 is a top view of a blocking unit in one embodiment. DETAILED DESCRIPTION

[0031] 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.

[0032] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0033] 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 herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0034] In order to more clearly describe the structure of the present invention, "distal" and "proximal" are used as directional words, which are commonly used terms in the field of interventional medical devices, wherein "distal" refers to the end away from the operator during the operation, and "proximal" refers to the end close to the operator during the operation.

[0035] like Figure 1As shown, this embodiment provides an occluder 100, including an occluding unit 10 and a head 141 connected to the occluding unit 10, the occluding unit 10 has a central axis AA, the central axis AA passes through the distal end and the proximal end of the occluder 100, the occluder 100 also includes a marking structure 20, the marking structure 20 includes a distal marker 211 and at least two first markers 212, the distal marker 211 is arranged on the head 141, each first marker 212 is connected to the occluding unit 10, each first marker 212 is located in the same placement plane, the placement plane is perpendicular to the central axis AA, the distal marker 211 is located outside the placement plane, the projection point of each first marker 212 in a projection plane perpendicular to the placement plane is located on a straight line segment, and in the natural state of the occluder 100, the line connecting the distal marker 211 and the two end points of the straight line segment forms a triangle.

[0036] The occluder 100 of this embodiment is used to occlude the defect of the atrial septum 300, such as Figure 2 Please also refer to Figure 3 As shown, the occluder 100 needs to be loaded into a conveyor before use. The conveyor includes a sheath tube 400 with an inner diameter of 2-5 mm. When the occluder 100 is implanted, a surgical operation needs to be performed under the guidance of an X-ray imaging device such as DSA (Digital Subtraction Angiography) so that the occluder 100 is conveyed to the distal end along the sheath tube 400. After being conveyed to the relevant lesion site, a force is applied to the occluder 100 to release the occluder 100 from the sheath tube 400 to the atrial septum 300 to block the defect of the atrial septum 300. Specifically, after the sheath tube 400 loaded with the occluder 100 passes through the atrial septum 300, a force is applied to the occluder 100 so that the occluding unit 10 moves to the outside of the sheath tube 400, and the occluding unit 10 is unfolded under the action of its own elastic force, thereby blocking the defect.

[0037] The marking structure 20 of the occluder 100 includes a distal marker 211 and at least two first markers 212. The distal marker 211 is arranged on the head 141. Each first marker 212 is connected to the occluding unit 10. Each first marker 212 is located in the same placement plane. The placement plane is perpendicular to the central axis AA. The distal marker 211 is arranged outside the placement plane. The projection point of each first marker 212 in a projection plane perpendicular to the placement plane is located on a straight line segment. In the natural state of the occluder 100, the line connecting the distal marker 211 and the two end points of the straight line segment is a triangle. During the release process of the occluder 100, the marking structure 20 can be developed under DSA to guide the release of the occluder 100.

[0038] Specifically, Figure 4aAs shown, a force is applied to the occluder 100 to make it deploy in the left atrium (herein, only the deployment of the occluder 100 in the left atrium is used as an example for explanation, but the invention is not limited thereto). By adjusting the parameters such as the probe angle of the DSA, the projection points of each first marker 212 in the image detected by the DSA in a projection plane perpendicular to the placement plane are located on a straight line segment, and the line connecting the distal marker 211 and the two end points of the straight line segment forms a triangle. At this time, the operator can apply a force to the occluder 100 to make it reciprocate, and observe whether the triangle is deformed during the reciprocating motion. If the triangle is not deformed during this process, it can be determined that the occluding unit 10 is not in contact with the atrial septum 300.

[0039] like Figure 4b As shown, the force is continuously applied to the occluding unit 10 to move the occluding unit 10 proximally until each first marker 212 is in contact with the atrial septum 300. During this process, the surgeon can be guided to perform the operation by observing the geometric shape of the triangle, and the surgeon can be assisted to understand the positional relationship between the occluding unit 10 and the atrial septum 300, so as to facilitate the subsequent operation of the occluding device 100. Specifically, when each first marker 212 is in contact with the atrial septum 300, the movement of each first marker 212 is restricted, while the distal marker 211 can move freely. At this time, the distal marker 211 continues to approach the atrial septum 300 and the first marker 212, and the triangle is deformed. At this time, it can be determined that the occluding unit 10 has been in contact with the atrial septum 300.

[0040] like Figure 4c As shown in FIG. 1 , after the occluding unit 10 is attached to the atrial septum 300, if the occluding unit 100 is continuously pulled proximally, the distal marker 211 continues to approach the atrial septum 300. When the projection of the distal marker 211 is collinear with the straight line segment, if a force is continuously applied to the occluding unit 100 to make the distal marker 211 continue to move closer to the atrial septum 300, as shown in FIG. Figure 4d As shown, the distal marker 211 may cross the defect position of the atrial septum 300, causing the occluder 100 to fall off. In this way, when the projection of the distal marker 211 is collinear with the straight line segment, it can serve as a warning to the operator to prevent the distal marker 211 from crossing the defect position of the atrial septum 300 and thus preventing the occluder 100 from falling off. Therefore, the occluder 100 in this embodiment can determine its accurate position and release state under DSA, thereby improving the success rate of the operation.

[0041] Furthermore, if Figure 1As shown, the blocking unit 10 includes a first subunit 11, the first subunit 11 includes a first mesh disk 111 and a first flow-blocking film 112 disposed in the first mesh disk 111, the central axis AA passes through the geometric center of the first mesh disk 111, and the central axis AA is perpendicular to the plane where the first mesh disk 111 is located, the central axis AA passes through the geometric center of the first flow-blocking film 112, and the central axis AA is perpendicular to the plane where the first flow-blocking film 112 is located, and each first marker 212 is connected to the first mesh disk 111. Or, as Figure 5 As shown, in another embodiment, each first marker 212 is connected to the first blocking film 112 .

[0042] In this embodiment, the central axis AA passes through the geometric center of the first mesh disk 111, and the central axis AA is perpendicular to the plane where the first mesh disk 111 is located, so that the plane where the first mesh disk 111 is located is perpendicular to the projection plane, and each first marker 212 is connected to the first mesh disk 111, so that the projection of each first marker 212 in the projection plane is located on the same straight line segment, and the projection of the distal marker 211 and the line connecting the two ends of the straight line segment form a triangle. Similarly, it can be known that the central axis AA passes through the geometric center of the first flow-blocking film 112, and the central axis AA is perpendicular to the plane where the first flow-blocking film 112 is located, so that the plane where the first flow-blocking film 112 is located is perpendicular to the projection plane, and each first marker 212 is connected to the first flow-blocking film 112, so that the projection of each first marker 212 in the projection plane is located on the same straight line segment, and further the projection of the distal marker 211 and the line connecting the two ends of the straight line segment form a triangle.

[0043] like Figure 4a As shown, during the operation, a force is applied to the occluder 100 so that the first subunit 11 is deployed in the left atrium. By adjusting the DSA probe angle and other parameters, the projection points of each first marker 212 in the projection plane in the image detected by the DSA are located on a straight line segment, and the line connecting the distal marker 211 and the two end points of the straight line segment is a triangle. The operator can apply a force to the occluder 100 to make it reciprocate, and observe whether the triangle is deformed during the reciprocating motion. If the triangle is not deformed during this process, it can be determined that the occluding unit 10 is not in contact with the atrial septum 300.

[0044] like Figure 4bAs shown, the force is continuously applied to the occluding unit 10, so that the occluding unit 10 moves proximally until the first mesh disk 111 or the first flow blocking film 112 is in contact with the atrial septum 300. In this process, the operator can be assisted in understanding the positional relationship between the first mesh disk 111 and the atrial septum 300 by observing the geometric shape of the triangle, so as to operate the subsequent release of the occluder 100. Specifically, when the first mesh disk 111 or the first flow blocking film 112 is in contact with the atrial septum 300, the movement of each first marker 212 is restricted, while the distal marker 211 can move freely. At this time, the distal marker 211 continues to approach the atrial septum 300 and the first marker 212, and the triangle is deformed. At this time, it can be determined that the first subunit 11 has been in contact with the atrial septum 300.

[0045] like Figure 4c As shown, after the first subunit 11 is attached to the atrial septum 300, if the occluder 100 is continuously pulled proximally, the distal marker 211 continues to approach the atrial septum 300. When the projection of the distal marker 211 is collinear with the straight line segment, if a force is continuously applied to the occluder 100 to make the distal marker 211 continue to move closer to the atrial septum 300, as shown in FIG. Figure 4d As shown, the distal marker 211 may cross the defect position of the atrial septum 300, causing the occluder 100 to fall off. In this way, when the projection of the distal marker 211 is collinear with the straight line segment, it can serve as a warning to the operator to prevent the distal marker 211 from crossing the defect position of the atrial septum 300, thereby avoiding the occluder 100 from falling off and improving the success rate of the operation.

[0046] In this embodiment, when the occluder 100 is used, the first mesh plate 111 and the first flow-blocking membrane 112 are delivered to the defect of the atrial septum 300 to block the defect of the atrial septum 300. The first mesh plate 111 is made of a material with elastic memory. When the first mesh plate 111 is delivered to the expected position and moves outside the sheath 400, the first mesh plate 111 can be unfolded and restored to a natural state under the action of its own elastic force, and the first mesh plate 111 can drive the first flow-blocking membrane 112 to unfold when it is restored to the natural state, so that the first mesh plate 111 and the first flow-blocking membrane 112 block the defect of the atrial septum 300.

[0047] Understandably, if Figure 1 As shown, each first marker 212 is fixed on the first mesh disk 111 , and in the natural state of the occluder 100 , the distance between each first marker 212 and the central axis AA is equal to the distance from the edge of the first mesh disk 111 to the geometric center of the first mesh disk 111 .

[0048] In this embodiment, during the operation, when the edge of the first mesh disk 111 is in contact with the atrial septum 300, each first marker 212 is fixed on the first mesh disk 111, and the distance between each first marker 212 and the central axis AA is equal to the distance from the edge of the first mesh disk 111 to the geometric center of the first mesh disk 111, which can ensure that each first marker 212 is in contact with the atrial septum 300, and can improve the accuracy of the guided surgery in which the distal marker 211 and the first marker 212 are used in combination.

[0049] In one embodiment, the first mesh disk 111 is circular, and the central axis AA passes through the center of the first mesh disk 111 (i.e., the geometric center of the first mesh disk 111), and each first marker 212 is fixed on the circumference of the first mesh disk 111, and the distance between each first marker 212 and the center of the first mesh disk 111 is equal to the radius of the first mesh disk 111.

[0050] Of course, in other embodiments, in the natural state of the occluder 100, the distance between each first marker 212 and the central axis AA may also be smaller than the distance from the edge of the first mesh disk 111 to the geometric center of the first mesh disk 111. For example, the first mesh disk 111 is circular, the central axis AA passes through the center of the first mesh disk 111 (i.e., the geometric center of the first mesh disk 111), each first marker 212 is fixed on the first mesh disk 111 along a circumference, and the distance between each first marker 212 and the center of the first mesh disk 111 is equal to the radius of the first mesh disk 111. Specifically, the diameter of the circumference of each first marker 212 is 1-8 mm smaller than the diameter of the first mesh disk 111. In this embodiment, the distance between each first marker 212 and the central axis AA can also be smaller than the distance from the edge of the first mesh disk 111 to the geometric center of the first mesh disk 111 to facilitate processing. In addition, when the occluder 100 is transported from the inside of the sheath 400 to the outside, the friction between the first marker 212 and the inner wall of the sheath 400 can be avoided, thereby preventing the first marker 212 from falling off.

[0051] It can be understood that each first marker 212 is fixed on the first flow-blocking film 112, and in the natural state of the occluder 100, the distance between at least one of the first markers 212 and the central axis AA is equal to the distance from the edge of the first flow-blocking film 112 to the geometric center of the first flow-blocking film 112. Or, as Figure 6 As shown, the distance between each first marker 212 and the central axis AA is smaller than the distance from the edge of the first blocking film 112 to the geometric center of the first blocking film 112 .

[0052] In this embodiment, when the spacing between the first marker 212 and the central axis AA is equal to the distance from the edge of the first flow-blocking film 112 to the geometric center of the first flow-blocking film 112, for example, the first flow-blocking film 112 is circular, the central axis AA passes through the center of the first flow-blocking film 112 (i.e., the geometric center of the first flow-blocking film 112), each first marker 212 is fixed to the edge of the first flow-blocking film 112, and the distance from each first marker 212 to the center of the first flow-blocking film 112 is equal to the radius of the first flow-blocking film. In surgery, the accuracy of guided surgery in which the distal marker 211 is used in conjunction with the first marker 212 can be improved. When the distance between each first marker 212 and the central axis AA is less than the distance from the edge of the first flow-blocking film 112 to the geometric center of the first flow-blocking film 112, friction between each first marker 212 and the inner wall of the sheath 400 can be avoided, thereby preventing the first marker 212 from falling off.

[0053] Preferably, in one embodiment, in the natural state of the occluder 100, the distance between each first marker 212 and the central axis AA is smaller than the distance from the edge of the first baffle film 112 to the geometric center of the first baffle film 112, and each first marker 212 is distributed along the first circumference, and the first circumference is concentrically arranged with the first baffle film 112.

[0054] In this embodiment, the distance between each first marker 212 and the central axis AA is smaller than the distance from the edge of the first flow-blocking film 112 to the geometric center of the first flow-blocking film 112. For example, the first flow-blocking film 112 is circular, and the central axis AA passes through the center of the first flow-blocking film 112 (i.e., the geometric center of the first flow-blocking film 112). Each first marker 212 is fixed on the first flow-blocking film 112 along the first circumference, and the diameter of the first circumference is smaller than the diameter of the first flow-blocking film by 1-8 mm. This can avoid friction between each first marker 212 and the inner wall of the sheath tube 400, thereby preventing the first marker 212 from falling off.

[0055] It can be understood that the first markers 212 are distributed at equal intervals along the first circumference, and the number of the first markers 212 ranges from 2 to 12.

[0056] Preferably, if Figure 5 As shown, in one embodiment, the marking structure 20 includes six first markers 212, and the six first markers 212 are distributed at equal intervals along the first circumference.

[0057] Understandably, if Figure 1As shown, the blocking unit 10 also includes a second subunit 12 connected to the first subunit 11, the second subunit 12 includes a second mesh disk 121 and a second flow-blocking film 122 arranged in the second mesh disk 121, the central axis AA passes through the geometric center of the second mesh disk 121, and the central axis AA is perpendicular to the plane where the second mesh disk 121 is located, the central axis AA passes through the geometric center of the second flow-blocking film 122, and the central axis AA is perpendicular to the plane where the second flow-blocking film 122 is located, and the marking structure 20 also includes at least two second markers 213, each of the second markers 213 is connected to the second mesh disk 121, or, each of the second markers 213 is connected to the second flow-blocking film 122.

[0058] In this embodiment, the central axis AA passes through the geometric center of the second mesh disk 121, and the central axis AA is perpendicular to the plane where the second mesh disk 121 is located, so that the plane where the second mesh disk 121 is located is perpendicular to the projection plane, and each second marker 213 is connected to the second mesh disk 121, so that the projection of each second marker 213 in the projection plane is located on the same straight line segment. Similarly, it can be known that the central axis AA passes through the geometric center of the second flow-blocking film 122, and the central axis AA is perpendicular to the plane where the second flow-blocking film 122 is located, so that the plane where the second flow-blocking film 122 is located is perpendicular to the projection plane, and each second marker 213 is connected to the second flow-blocking film 122, so that the projection of each second marker 213 in the projection plane is located on the same straight line segment.

[0059] It can be understood that each second marker 213 is fixed on the second mesh plate 121. In the natural state of the occluder 100, Figure 1 As shown, the distance between each second marker 213 and the central axis AA is equal to the distance from the edge of the second mesh plate 121 to the geometric center of the second mesh plate 121. In this embodiment, in the natural state of the occluder 100, the distance between each second marker 213 and the central axis AA is equal to the distance from the edge of the second mesh plate 121 to the geometric center of the second mesh plate 121. During surgery, when the edge of the second mesh plate 121 is in contact with the atrial septum 300, it can be ensured that each second marker 213 is in contact with the atrial septum 300, which can improve the accuracy of the guidance of the second marker 213.

[0060] It can be understood that the central axis AA passes through the geometric center of the second mesh disk 121, and the central axis AA is perpendicular to the plane where the second mesh disk 121 is located. Each second marker 213 is fixed on the second mesh disk 121. In the natural state of the occluder 100, the distance between each second marker 213 and the central axis AA is smaller than the distance from the edge of the second mesh disk 121 to the geometric center of the second mesh disk 121. In this embodiment, in the natural state of the occluder 100, the distance between each second marker 213 and the central axis AA is smaller than the distance from the edge of the second mesh disk 121 to the geometric center of the second mesh disk 121. When the second mesh disk 121 is located in the sheath tube 400, the friction between the second marker 213 and the inner wall of the sheath tube 400 can be avoided, thereby preventing the second marker 213 from falling off.

[0061] It can be understood that each second marker 213 is fixed on the second flow-blocking film 122. In the natural state of the occluder 100, the distance between at least one of the second markers 213 and the central axis AA is equal to the distance from the edge of the second flow-blocking film 122 to the geometric center of the second flow-blocking film 122, or the distance between each second marker 213 and the central axis AA is less than the distance from the edge of the second flow-blocking film 122 to the geometric center of the second flow-blocking film 122.

[0062] Preferably, in the natural state of the occluder 100, the distance between each second marker 213 and the central axis AA is less than the distance from the edge of the second flow-blocking film 122 to the geometric center of the second flow-blocking film 122, and each second marker 213 is distributed along the second circumference, and the second circumference is concentrically arranged with the second flow-blocking film 122. In this embodiment, the distance between each second marker 213 and the central axis AA is less than the distance from the edge of the second flow-blocking film 122 to the geometric center of the second flow-blocking film 122, and each second marker 213 is located on a second circumference. When the second flow-blocking film 122 is located in the sheath tube 400, the friction between the second marker 213 and the inner wall of the sheath tube 400 can be avoided, thereby preventing the second marker 213 from falling off.

[0063] Preferably, the second markers 213 are distributed at equal intervals along the second circumference, and the number of the second markers 213 ranges from 2 to 12.

[0064] Understandably, if Figure 1As shown, the blocking unit 10 also includes a waist 131 and a third baffle film 132, the two ends of the waist 131 are respectively connected to the first mesh disk 111 and the second mesh disk 121, the third baffle film 132 is arranged in the waist 131, and the marking structure 20 also includes at least two third markers 214, the center axis AA passes through the geometric center of the third baffle film 132, and the center axis AA is perpendicular to the plane where the third baffle film 132 is located, and each third marker 214 is connected to the waist 131, or, each third marker 214 is connected to the third baffle film 132.

[0065] In this embodiment, the central axis AA passes through the geometric center of the third flow-blocking film 132, and the central axis AA is perpendicular to the plane where the third flow-blocking film 132 is located, so that the plane where the third flow-blocking film 132 is located is perpendicular to the projection plane, and each third marker 214 is connected to the third flow-blocking film 132, so that the projection of each second marker 213 in the projection plane is located on the same straight line segment. During the operation, when the first subunit 11 reaches the expected position (i.e., the first subunit 11 is attached to the atrial septum 300), by adjusting the angle and other parameters of the DSA probe, the straight line formed by the third marker 214 and the straight line formed by the first marker 212 in the projection plane are parallel to each other, and the surgeon can judge the relative position of the third marker 214 and the atrial septum 300 by the size of the distance between the two straight lines, and then judge the relative position of the waist 131 and the third flow-blocking film 132 and the atrial septum 300.

[0066] It can be understood that each third marker 214 is connected to the third flow-blocking film 132. In the natural state of the occluder 100, the distance between at least one of the third markers 214 and the central axis AA is equal to the distance from the edge of the third flow-blocking film 132 to the geometric center of the third flow-blocking film 132, or the distance between each third marker 214 and the central axis AA is less than the distance from the edge of the third flow-blocking film 132 to the geometric center of the third flow-blocking film 132.

[0067] In this embodiment, when the distance between the third marker 214 and the central axis AA is equal to the distance from the edge of the third baffle film 132 to the geometric center of the third baffle film 132, it helps to improve the accuracy of the guided surgery by the third marker 214. When the distance between the third marker 214 and the central axis AA is less than the distance from the edge of the third baffle film 132 to the geometric center of the third baffle film 132, during the release process of the waist 131, the third marker 214 can be avoided from rubbing against the inner wall of the sheath 400, and the third marker 214 can be prevented from falling off.

[0068] In one embodiment, the third flow-blocking film 132 is circular, the central axis AA passes through the center of the third flow-blocking film 132 (i.e., the central axis AA passes through the geometric center of the third flow-blocking film 132), and the central axis AA is perpendicular to the plane where the third flow-blocking film 132 is located, and each third marker 214 is fixed on the third flow-blocking film 132 along a circumference, and the diameter of the circumference where each third marker 214 is located is 1-8 mm smaller than the diameter of the third flow-blocking film 132. During the release process of the waist 131, the friction between the third marker 214 and the inner wall of the sheath tube 400 can be avoided, and the third marker 214 can be prevented from falling off.

[0069] Of course, in another embodiment, the waist 131 is circular, the central axis AA passes through the center of the waist 131 (i.e., the central axis AA passes through the geometric center of the waist 131), and each third marker 214 is fixed on the waist 131 along a circumference, and the diameter of the circumference where each third marker 214 is located is 1-8 mm smaller than the diameter of the waist 131. During the release process of the waist 131, the third marker 214 can be prevented from rubbing against the inner wall of the sheath 400, and the third marker 214 can be prevented from falling off.

[0070] Preferably, if Figure 7 As shown, in one embodiment, the number of the first marker 212, the second marker 213 and the third marker 214 are all 2. In the natural state of the occluder 100, the two first markers 212 are located at both ends of the same diameter of the first baffle film 112, the two second markers 213 are located at both ends of the same diameter of the second baffle film 122, and the two third markers 214 are located at both ends of the same diameter of the third baffle film 132, and the two first markers 212, the two second markers 213 and the two third markers 214 are coplanar.

[0071] In this embodiment, the two first markers 212 , the two second markers 213 and the two third markers 214 are coplanar, which helps to improve the accuracy of determining the shapes of the first mesh plate 111 , the second mesh plate 121 and the waist 131 .

[0072] like Figure 1 As shown, the occluder 100 further includes a plug head 151 , which is fixed to the proximal end of the occluding unit 10 , and the delivery device further includes a delivery head made of a developing material, which is threadedly connected to the plug head 151 .

[0073] Understandably, if Figure 1 and Figure 4a As shown, the occluder 100 also includes a locking pin 161, which connects the closure head 141 and the plug head 151. The marking structure 20 also includes a proximal marker arranged in the plug head 151. The relative position between the proximal marker and the delivery head can be used to determine whether the occluder 100 and the delivery device are successfully separated.

[0074] It can be understood that during the release of the first mesh disk 111, the first baffle film 112 is released together with the first mesh disk 111. Similarly, during the release of the second mesh disk 121, the second baffle film 122 is also released together with the second mesh disk 121. When the waist 131 is released, the third baffle film 132 is released together with the waist 131.

[0075] It can be understood that the first mesh plate 111, the second mesh plate 121 and the waist 131 can be prepared by weaving, cutting and the like. Taking weaving as an example, the material of the weaving wire can be non-degradable metal materials such as NiTi alloy, Co-Cr alloy, stainless steel, or biodegradable materials.

[0076] When the first mesh plate 111, the second mesh plate 121 and the waist portion 131 are made of biodegradable materials, the biodegradable materials include but are not limited to polylactic acid (PLA), polyracemic lactic acid (PDLLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxyalkanoic acid ester (PHA), polydioxanone (PDO), or polycaprolactone (PCL), etc. The woven first mesh plate 111, the second mesh plate 121 and the waist portion 131 are formed into a predetermined shape by heat treatment of a mold.

[0077] The material of the marking structure 20 can be a metal substance, such as gold, platinum, barium sulfate, etc., or a non-metallic substance, such as sodium bromide, sodium iodide, iodine, iodide, etc. When the first marker 212 is fixed to the first mesh disk 111, the first marker 212 is fixed to the grid intersection of the first mesh disk 111, or is wrapped around the braided monofilament, or is welded on the braided monofilament, or is coated on the surface of the braided monofilament. The above-mentioned setting method of the marking structure 20 is simple in structure, firm and reliable, and will not affect the overall structure of the occluder 100 itself.

[0078] It can be understood that when the second marker 213 is fixed to the second mesh disk 121, the above-mentioned fixing method may be referred to, and when the third marker 214 is fixed to the waist 131, the above-mentioned fixing method may also be referred to, which will not be described in detail here.

[0079] It can be understood that when the first marker 212 is fixed on the first flow-blocking film 112, the fixing method thereof can be embedding, bonding, suturing, etc.

[0080] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above 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.

[0081] The above 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 those of ordinary skill in the art, 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 occluder, comprising an occluding unit and a sealing head connected to the occluding unit, wherein the occluding unit has a central axis, and the central axis passes through the distal end and the proximal end of the occluder, characterized in that: The occluding unit includes a first subunit, which includes a first mesh disk and a first baffle film arranged in the first mesh disk. The occluder also includes a marking structure, which includes a distal marker and at least two first markers. The distal marker is arranged on the end cap, each of the first markers is located in the same placement plane, and each of the first markers is fixed on the first baffle film. In the natural state of the occluder, the distance between each of the first markers and the central axis is smaller than the distance from the edge of the first baffle film to the geometric center of the first baffle film. The placement plane is perpendicular to the central axis, the distal marker is located outside the placement plane, and the projection point of each of the first markers in a projection plane perpendicular to the placement plane is located on a straight line segment. In the natural state of the occluder, the line connecting the distal marker and the two end points of the straight line segment is a triangle. Under the action of external force, the distal marker of the occluder can be located on the same straight line segment as the projection point of each of the first markers in a projection plane perpendicular to the placement plane.

2. The occluder according to claim 1, characterized in that: In the natural state of the occluder, the first flow-blocking membrane is circular, the central axis passes through the geometric center of the first mesh disk, and the central axis is perpendicular to the plane where the first mesh disk is located, the central axis passes through the geometric center of the first flow-blocking membrane, and the central axis is perpendicular to the plane where the first flow-blocking membrane is located, and each of the first markers is fixed on the first flow-blocking membrane along a first circumference, and the diameter of the first circumference is smaller than the diameter of the first flow-blocking membrane by 1-8 mm.

3. The occluder according to claim 1, characterized in that: The first marker is fixed on the first flow-blocking film in one or more ways: embedding, bonding and suturing.

4. The occluder according to claim 1, characterized in that: The occluder also includes a plug head, which is fixed to the proximal end of the occluding unit, and a locking pin is connected between the occluder head and the plug head.

5. The occluder according to claim 2, characterized in that: In the natural state of the occluder, the first circumference is concentrically arranged with the first flow-blocking membrane.

6. The occluder according to claim 2, characterized in that: The first markers are distributed at equal intervals along the first circumference, and the number of the first markers ranges from 2 to 12.

7. The occluder according to claim 1, characterized in that: The blocking unit also includes a second subunit connected to the first subunit, the second subunit includes a second mesh disk and a second flow-blocking membrane arranged in the second mesh disk, the central axis passes through the geometric center of the second mesh disk, and the central axis is perpendicular to the plane where the second mesh disk is located, the central axis passes through the geometric center of the second flow-blocking membrane, and the central axis is perpendicular to the plane where the second flow-blocking membrane is located, and the marking structure also includes at least two second markers, each of the second markers is connected to the second mesh disk, or each of the second markers is connected to the second flow-blocking membrane.

8. The occluder according to claim 7, characterized in that: Each of the second markers is fixed on the second mesh disk. In the natural state of the occluder, the distance between each of the second markers and the central axis is equal to or less than the distance from the edge of the second mesh disk to the geometric center of the second mesh disk.

9. The occluder according to claim 7, characterized in that: Each of the second markers is fixed on the second flow-blocking membrane. In the natural state of the occluder, the distance between at least one of the second markers and the central axis is equal to the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane, or the distance between each of the second markers and the central axis is smaller than the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane.

10. The occluder according to claim 9, characterized in that: In the natural state of the occluder, the distance between each second marker and the central axis is smaller than the distance from the edge of the second flow-blocking membrane to the geometric center of the second flow-blocking membrane, and each second marker is distributed along a second circumference, which is concentrically arranged with the second flow-blocking membrane.

11. The occluder according to claim 10, characterized in that: The second markers are distributed at equal intervals along the second circumference, and the number of the second markers ranges from 2 to 12.

12. The occluder according to claim 7, characterized in that: The blocking unit also includes a waist and a third baffle membrane, the two ends of the waist are respectively connected to the first mesh disk and the second mesh disk, the third baffle membrane is arranged in the waist, the central axis passes through the geometric center of the third baffle membrane, and the central axis is perpendicular to the plane where the third baffle membrane is located, and the marking structure also includes at least two third markers, each of the third markers is connected to the waist, or each of the third markers is connected to the third baffle membrane.

13. The occluder according to claim 12, characterized in that: Each of the third markers is connected to the third flow-blocking membrane. In the natural state of the occluder, the distance between at least one of the third markers and the central axis is equal to the distance from the edge of the third flow-blocking membrane to the geometric center of the third flow-blocking membrane, or the distance between each of the third markers and the central axis is less than the distance from the edge of the third flow-blocking membrane to the geometric center of the third flow-blocking membrane.

14. The occluder according to claim 12, characterized in that: The number of the first marker, the second marker and the third marker are all two. In the natural state of the occluder, the two first markers are located at the two ends of the same diameter of the first baffle membrane, the two second markers are located at the two ends of the same diameter of the second baffle membrane, the two third markers are located at the two ends of the same diameter of the third baffle membrane, and the two first markers, the two second markers and the two third markers are coplanar.

15. The occluder according to claim 4, characterized in that: The plug head is threadedly connected to the delivery head of the conveyor, the delivery head is made of a developing material, and the marking structure also includes a proximal marker arranged in the plug head.

16. The occluder according to claim 13, characterized in that: The third flow-blocking film is circular, and each of the third markers is fixed on the third flow-blocking film along a circumference. The diameter of the circumference where each of the third markers is located is 1-8 mm smaller than the diameter of the third flow-blocking film.

17. The occluder according to claim 12, characterized in that: The first mesh plate, the second mesh plate and the waist are made of biodegradable materials, and the biodegradable materials include any one of polylactic acid (PLA), polyracemic lactic acid (PDLLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO), or polycaprolactone (PCL).

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