CN112773417A

CN112773417A - Plugging device

Info

Publication number: CN112773417A
Application number: CN201911073105.9A
Authority: CN
Inventors: 王高波; 张翠茹; 陈贤淼
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-11-05
Filing date: 2019-11-05
Publication date: 2021-05-11
Anticipated expiration: 2039-11-05
Also published as: CN112773417B

Abstract

The invention relates to an occluder. The plugging device comprises a plugging frame, wherein the plugging frame comprises a first plugging unit, a second plugging unit and a waist, the two ends of the waist are respectively connected with the first plugging unit and the second plugging unit, the first plugging unit is provided with a plurality of first mark structures, the second plugging unit is provided with a plurality of second mark structures, the waist is provided with a plurality of third mark structures, the geometric center connecting lines of the plurality of first mark structures are straight lines, the geometric center connecting lines of the plurality of second mark structures are straight lines, the geometric center connecting lines of the plurality of third mark structures are straight lines, and the developing strength, the developing size and/or the developing shape of the plurality of first mark structures, the plurality of second mark structures and the plurality of third mark structures under the medical imaging equipment are different. Whether the release form of the occluder is good or not can be judged in the operation process.

Description

Plugging device

Technical Field

The invention relates to the field of implantable medical devices, in particular to an occluder.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

The heart plugging device is an implanted medical appliance for treating congenital heart defects. The conventional cardiac occluder is usually made of shape memory alloy, the shape memory alloy is visible under medical imaging equipment such as a Digital Subtraction Angiography (DSA) and the like, and the implantation operation can be ensured to be smoothly performed under the condition that a developing marker structure is not additionally arranged.

However, for the absorbable occluder made of polymer material, the polymer material itself is invisible or poorly visible under medical imaging devices such as DSA, and it is difficult to ensure smooth operation. Although some absorbable occluders are provided with a plurality of developing points to assist in judging the general position of the absorbable occluder, it is difficult to judge whether the shape of the occluder after being released is good or not through the developing points in the operation process, so that the operation is difficult, and the risk in the operation process is increased.

Disclosure of Invention

Based on this, it is necessary to provide an occluder which can determine whether the release profile is good or not during the operation.

An occluder comprises an occlusion frame, the occlusion frame comprises a first occlusion unit, a second occlusion unit and a waist, the two ends of the waist are respectively connected with the first plugging unit and the second plugging unit, the first plugging unit is provided with a plurality of first marking structures, a plurality of second marking structures are arranged on the second plugging unit, a plurality of third marking structures are arranged on the waist, under at least one incident direction of a light source under the medical imaging equipment, the central connecting lines of the plurality of first mark structures are in a straight line, the central connecting lines of the plurality of second mark structures are straight lines, the central connecting lines of the plurality of third mark structures are straight lines, and the plurality of first mark structures, the plurality of second mark structures and the plurality of third mark structures have different developing strength, different developing size and/or different developing shape under the medical imaging equipment.

In one embodiment, the first, second and third marking structures have different densities of material and different thicknesses.

In one embodiment, when the densities of the materials of the first mark structure, the second mark structure and the third mark structure are different, the difference in thickness between the first mark structure, the second mark structure and the third mark structure is at least 80 micrometers; and a minimum thickness of any of the first mark structure, the second mark structure, and the third mark structure is 70 micrometers.

In one embodiment, when the densities of the materials of the first mark structure, the second mark structure and the third mark structure are different, and the thicknesses of the first mark structure, the second mark structure and the third mark structure are different, the difference of the surface area sizes of the first mark structure, the second mark structure and the third mark structure is at least 0.2 square millimeter; and, any of the first, second, and third marker structures has a surface area of at least 0.2 square millimeters.

In one embodiment, the occluder further comprises a first flow-blocking membrane disposed on the first occluding unit, a second flow-blocking membrane disposed on the second occluding unit, and a third flow-blocking membrane disposed on the waist.

In one embodiment, the first fluid-resistant film comprises a first upper film and a first lower film disposed in a stack, the plurality of first marker structures being disposed between the first upper film and the first lower film; the second flow blocking film comprises a second upper film and a second lower film which are arranged in a stacked mode, and the plurality of second mark structures are arranged between the second upper film and the second lower film; the third spoiler film includes a third upper film and a third lower film that are stacked, and the plurality of third mark structures are disposed between the third upper film and the third lower film.

In one embodiment, the distance from the edge of each first mark structure to the edge of the first flow resistance film is 0-2 mm, the distance from the edge of each second mark structure to the edge of the second flow resistance film is 0-2 mm, and the distance from the edge of each third mark structure to the edge of the third flow resistance film is 0-2 mm.

In one embodiment, when the occluder is in a stretched state, the center of the first flow-resistant membrane extends in a distal direction or a proximal direction close to the occluder, and the edges of the first flow-resistant membrane contract to form a first bag-like structure, and the plurality of first marker structures are located inside the first bag-like structure; the center of the second flow-resisting film extends towards the far end direction or the near end direction of the occluder, the edge of the second flow-resisting film shrinks to form a second bag-shaped structure, and the plurality of second mark structures are positioned inside the second bag-shaped structure; the center of the third flow-resisting film extends towards the far end direction or the near end direction of the occluder, the edge of the third flow-resisting film shrinks to form a third bag-shaped structure, and the plurality of third mark structures are positioned inside the third bag-shaped structure.

In one embodiment, the number of the first mark structures is at least 3, and in a natural state, a connecting line of the at least 3 first mark structures is a regular polygon;

the number of the second marking structures is at least 3, and in a natural state, the connecting line of the at least 3 second marking structures is a regular polygon;

the number of the third mark structures is at least 3, and in a natural state, the connecting line of the at least 3 third mark structures is a regular polygon.

In one embodiment, the occlusion device further comprises a distal end socket and a distal end marking structure, the distal end socket is connected with one end, far away from the waist, of the first occlusion unit, the distal end marking structure is arranged on the distal end socket, and the distal end marking structure and the first marking structure are different in development strength, development size and/or development shape under medical imaging equipment.

The first mark structures, the second mark structures and the third mark structures of the occluder have different development intensities, different development sizes and/or different development shapes under medical imaging equipment, so that the first occluding unit, the second occluding unit and the waist of the occluder can be identified through the medical imaging equipment; and when the central connecting lines of the plurality of first mark structures are straight lines, the central connecting lines of the plurality of second mark structures are straight lines, and the central connecting lines of the plurality of third mark structures are straight lines, the indicator occluder is indicated to be well formed at the defect part. Therefore, it is possible to determine whether the release form of the occluder is good or not during the operation.

Drawings

FIG. 1 is a schematic structural view of an embodiment of an occluding device;

FIG. 2a is a schematic diagram of a first fluid blocking film and a first marker structure according to an embodiment;

FIG. 2b is a schematic diagram of a first fluid barrier film and a first marker structure according to another embodiment;

FIG. 3a is a schematic diagram of a first fluid blocking film and a first marker structure according to an embodiment;

FIG. 3b is a schematic diagram of a first fluid barrier film and a first marker structure according to another embodiment;

FIG. 4a is a schematic diagram of a first fluid barrier film and a first marker structure according to an embodiment;

FIG. 4b is a schematic diagram of a first fluid barrier film and a first marker structure according to another embodiment;

figure 5 is a schematic view of an embodiment of an occluding device in a partially stretched state;

figure 6 is a schematic view of an embodiment of the occluding device in a fully extended state.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, the "distal end" is defined as the end that is distal from the operator during the procedure, and the "proximal end" is defined as the end that is proximal to the operator during the procedure.

Referring to fig. 1, an embodiment of an occluding device 100 includes an occluding frame 20, a plurality of first marker structures 30, a plurality of second marker structures 40, and a plurality of third marker structures 50. In one embodiment, the occluding frame 20 is a mesh structure woven from a plurality of wires. The material of the wire may be a metal that is not corrodible in the living body, and the wire may be a nitinol wire, a cobalt-chromium alloy wire, a stainless steel wire, or the like, for example. Alternatively, the thread may be made of a biodegradable material. For example, the biodegradable material may be poly (racemic lactic acid) (PDLLA), poly (D-lactic acid) (PDLA), poly (L-lactic acid) (PLLA), poly (glycolic acid) (PGA), poly (lactic-co-glycolic acid) (PLGA), poly (hydroxy fatty acid ester) (PHA), Polydioxanone (PDO), or Polycaprolactone (PCL), etc. In one embodiment, the occluding frame 20 is formed by 3D printing.

The occlusion frame 20 comprises a first occlusion unit 22, a second occlusion unit 24 and a waist 26. The two ends of the waist 26 are respectively connected with the first plugging unit 22 and the second plugging unit 24 to form a two-disc and one-waist structure with two large ends and a small middle. In one embodiment, the first occluding unit 22, the second occluding unit 24 and the waist 26 are a unitary structure.

The plurality of first marker structures 30 are disposed on the first occlusive device 22, the plurality of second marker structures 40 are disposed on the second occlusive device 24, and the plurality of third marker structures 50 are disposed on the waist 26. In at least one incident direction of the light and shadow of the medical imaging apparatus, the central connecting lines of the first mark structures 30 are straight lines, the central connecting lines of the second mark structures 40 are straight lines, and the central connecting lines of the third mark structures 50 are straight lines, and the first mark structures 30, the second mark structures 40 and the third mark structures 50 have different development intensities, different development sizes and/or different development shapes under the medical imaging apparatus.

When the first mark structure 30, the second mark structure 40, and the third mark structure 50 have regular shapes, the center is a geometric center. When the first mark structure 30, the second mark structure 40 and the third mark structure 50 have irregular shapes, the center refers to the center of gravity. However, whether regular or irregular, the connecting lines of the first marker structure 30, the second marker structure 40 and the third marker structure 50 may be considered to pass through the geometric center or the center of gravity due to the small surface area of the first marker structure 30, the second marker structure 40 and the third marker structure 50.

It should be noted that the difference in the development intensity, the development size and/or the development shape of the plurality of first marker structures 30, the plurality of second marker structures 40 and the plurality of third marker structures 50 in the medical imaging device refers to the following parallel situations:

1. the plurality of first marker structures 30, the plurality of second marker structures 40 and the plurality of third marker structures 50 differ in development intensity under the medical imaging device;

2. the plurality of first marker structures 30, the plurality of second marker structures 40 and the plurality of third marker structures 50 are developed in different sizes under the medical imaging device;

3. the plurality of first marker structures 30, the plurality of second marker structures 40 and the plurality of third marker structures 50 are different in development shape under the medical imaging device;

4. the plurality of first mark structures 30, the plurality of second mark structures 40 and the plurality of third mark structures 50 have different development intensities under the medical imaging equipment and different development sizes;

5. the plurality of first mark structures 30, the plurality of second mark structures 40 and the plurality of third mark structures 50 have different development intensities and different development shapes under the medical imaging equipment;

6. the plurality of first mark structures 30, the plurality of second mark structures 40 and the plurality of third mark structures 50 have different development sizes and different development shapes under the medical imaging equipment;

7. the plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 all differ in development intensity, development size, and development shape under the medical imaging device.

In one embodiment, the difference in imaging intensity refers to a difference in radiopacity or a difference in fluorescence intensity. In one embodiment, the development intensity is different, so that the colors of the first mark structure 30, the second mark structure 40 and the third mark structure 50 visible to human eyes are different under the medical imaging device.

The difference in the development size is that the coverage area of the first mark structure 30, the second mark structure 40 and the third mark structure 50 visible to the human eye is different under the medical imaging device.

The difference in development shape means, for example, that in one embodiment, the first mark structure 30 is circular, the second mark structure 40 is triangular, and the third mark structure 50 is square. In another embodiment, the shape of the first marker structure 30, the second marker structure 40 and the third marker structure 50 may be selected from a crescent, a star and other regular or irregular shapes.

In one embodiment, the first marker structure 30, the second marker structure 40 and the third marker structure 50 have different shapes, and the first marker structure 30, the second marker structure 40 and the third marker structure 50 are different colors visible to the human eye under the medical imaging device.

In one embodiment, the material of the first marker structure 30, the second marker structure 40 and the third marker structure 50 is a metallic material. For example, in one embodiment, the first marker structure 30, the second marker structure 40, and the third marker structure 50 are made of a bioabsorbable metal such as gold, tantalum, platinum, tungsten, or iridium.

In another embodiment, the material of the first marker structure 30, the second marker structure 40, and the third marker structure 50 is a bioabsorbable metal such as iron, magnesium, or the like. When the material of the silk thread is also biodegradable, the first marker structure 30, the second marker structure 40 and the third marker structure 50 are made of absorbable metals of organisms, so that the occluder 100 is completely biodegradable, after occlusion is completed, the occluder 100 is completely degraded without any metal residue, and long-term clinical risk is avoided.

In one embodiment, the densities of the materials of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are different, and the thicknesses of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are different, so that the developing strengths of the first mark structure 30, the second mark structure 40 and the third mark structure 50 under the medical imaging device are different.

When the materials of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are the same, the thicknesses of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are different, so that the developing strength of the first mark structure 30, the second mark structure 40 and the third mark structure 50 under the medical imaging device is different. However, for sufficient discrimination, the first mark structure 30, the second mark structure 40 and the third mark structure 50 need to have sufficient thickness difference, so that the thickness of one of the first mark structure 30, the second mark structure 40 and the third mark structure 50 may be relatively large, thereby causing difficulty in transportation. Therefore, the first mark structure 30, the second mark structure 40 and the third mark structure 50 are made of materials with different densities, the materials with different densities have different development strengths under medical imaging equipment, and proper thickness difference is combined, so that sufficient discrimination can be obtained under the medical imaging equipment, and the thickness of any one of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is not too large, and conveying difficulty cannot be caused.

In an embodiment, when the densities of the materials of the first marker structure 30, the second marker structure 40 and the third marker structure 50 are different, the difference in thickness between the first marker structure 30, the second marker structure 40 and the third marker structure 50 is at least 80 microns, such that under a medical imaging device, the images presented by the first marker structure 30, the second marker structure 40 and the third marker structure 50 have a sufficient color difference to be distinguishable by the human eye. And, the minimum thickness of any of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is 70 micrometers.

It should be noted that the difference in thickness between the first mark structure 30, the second mark structure 40, and the third mark structure 50 is at least 80 micrometers, which means that the difference in thickness between two of the first mark structure 30, the second mark structure 40, and the third mark structure 50 is at least 80 micrometers. For example, the thickness of the first marker structure 30 is at least 80 microns greater than the thickness of the second marker structure 40, and the thickness of the second marker structure 40 is at least 80 microns greater than the thickness of the third marker structure 50. As another example, the thickness of the first marker structure 30 is at least 80 microns greater than the thickness of the third marker structure 40, the thickness of the second marker structure 40 is at least 80 microns greater than the thickness of the third marker structure 50, and the difference in the thicknesses of the first marker structure 30 and the second marker structure 40 is at least 80 microns.

Setting a minimum thickness of any one of the first, second and

third marker structures

30, 40, 50 to 70 microns to ensure sufficient clarity of the first, second and

third marker structures

30, 40, 50 such that the visibility of the first, second and

third marker structures

30, 40, 50 is good; meanwhile, when the materials of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are the same, the difference in thickness between the first mark structure 30, the second mark structure 40 and the third mark structure 50 is at least 80 μm to obtain sufficient discrimination. The minimum thickness is within 70 microns and the minimum thickness difference is the combination of 80 microns, obtains the visibility, the visibility differentiation and reasonable thickness, avoids increasing the whole compliance of occluder 100 and increases the degree of difficulty of carrying.

In one embodiment, the difference in thickness between the first marker structure 30 and the third marker structure 50 is at least 80 microns, and the thickness of the second marker structure 40 is equal to the thickness of the first marker structure 30. Because the first mark structure 30 is adjacent to the third mark structure 50, the second mark structure 40 is adjacent to the third mark structure 50, and the first mark structure 30 and the second mark structure 40 are arranged at intervals in the axial direction, only the thickness difference is formed between the first mark structure 30 and the third mark structure 50, the thickness difference is formed between the second mark structure 40 and the third mark structure 50, and the thickness difference is not formed between the first mark structure 30 and the second mark structure 40, it can be ensured that the first blocking unit 22, the second blocking unit 24 and the waist portion 26 can be identified and distinguished under the medical imaging equipment, and the thickness of any one of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is not too large to affect the transportation.

In one embodiment, the thicknesses of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are the same, and the densities of the material of the first mark structure 30, the material of the second mark structure 40 and the material of the third mark structure 50 are different, so that the developing strengths of the first mark structure 30, the second mark structure 40 and the third mark structure 50 under the medical imaging device are different. For example, in a DSA imaging device, the metal with higher density appears bright black, and the metal with lower density appears gray, so that different marker structures can be distinguished, and thus different parts of the occlusion frame 20 can be distinguished.

In one embodiment, when the thicknesses of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are the same, and the densities of the material of the first mark structure 30, the material of the second mark structure 40 and the material of the third mark structure 50 are different, the difference of the surface area sizes of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is at least 0.2mm²To further enable the images presented by the first marker structure 30, the second marker structure 40 and the third marker structure 50 under the medical imaging device to be sufficiently distinguishable to enable human eyes to distinguish. And, the surface area of any one of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is at least 0.2mm²。

When the surface area of the first marker structure 30, the second marker structure 40 and the third marker structure 50 is too large, the larger the size of the matched delivery sheath needs to be. Thus, the first marker structure 30, the second marker structure 40 andthe surface area of the third marker structure 50 should be controlled within a certain range. However, when the surface areas of the first marker structure 30, the second marker structure 40, and the third marker structure 50 are too small, the indication effect on the morphology of the occluding device 100 is not good. Thus, in one embodiment, any of the first marker structure 30, the second marker structure 40 and the third marker structure 50 has a surface area of at least 0.2mm²And the difference in the surface area size of the first marker structure 30, the second marker structure 40 and the third marker structure 50 is at least 0.2mm²So as to obtain better visibility and visibility differentiation, and can use a conveying sheath tube with smaller size for conveying.

It should be noted that the difference in the surface area size of the first marker structure 30, the second marker structure 40 and the third marker structure 50 is at least 0.2mm²The difference of the area sizes of the first mark structure 30, the second mark structure 40 and the third mark structure 50 is at least 0.2mm no matter what the shapes of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are respectively and no matter whether the shapes of the first mark structure 30, the second mark structure 40 and the third mark structure 50 are the same or not². Moreover, in the first mark structure 30, the second mark structure 40 and the third mark structure 50, there is a difference in surface area between each two of them, and the difference in surface area between each two of them is at least 0.2mm²。

In one embodiment, the first mark structures 30, the second mark structures 40 and the third mark structures 50 have different developing strengths under the medical imaging device, and the first mark structures 30, the second mark structures 40 and the third mark structures 50 have different developing shapes, so that different parts of the occluding frame 20 can be distinguished more significantly, which is beneficial for an operator to accurately identify the release form of the occluding device 100 and improve the success rate of the operation.

The plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 of the occluder 100 are respectively disposed on the first occluder unit 22, the second occluder unit 24, and the waist portion 26 of the occluder frame 20, and the plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 have different development strengths, different development sizes, or different development shapes under the medical imaging device, so that the first occluder unit 22, the second occluder unit 24, and the waist portion 26 of the occluder frame 20 can be identified by the medical imaging device.

And when the connecting lines of the centers of the plurality of first mark structures 30 are straight, the connecting lines of the centers of the plurality of second mark structures 40 are straight, and the connecting lines of the centers of the plurality of third mark structures 50 are straight, the plugging device is indicated to be well formed at the defect part in at least one incident direction of the light and shadow of the medical imaging equipment. Therefore, it is possible to determine whether the release form of the occluding device 100 is good or not during the operation.

In one embodiment, the plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 are disposed directly on the occluding frame 20. For example, a plurality of first marker structures 30 are wrapped around the filaments of the first occluding unit 22, a plurality of second marker structures 40 are wrapped around the filaments of the second occluding unit 24, and a plurality of third marker structures 50 are wrapped around the filaments of the waist 26.

In one embodiment, the occluding device 100 further comprises a first flow blocking membrane 62, a second flow blocking membrane 64 and a third flow blocking membrane 66, the first flow blocking membrane 62 being disposed on the first occluding cell 22, the second flow blocking membrane 64 being disposed on the second occluding cell 24, and the third flow blocking membrane 66 being disposed on the waist 26. The first flow-blocking film 62, the second flow-blocking film 64 and the third flow-blocking film 66 are arranged, so that residual shunting is avoided, and the instant plugging property is improved.

In one embodiment, referring to fig. 1, fig. 2a and fig. 2b, a plurality of first mark structures 30 are disposed on the first current blocking film 62. Referring to fig. 1, fig. 3a and fig. 3b, a plurality of second mark structures 40 are disposed on the second flow-blocking film 64. Referring to fig. 1, fig. 4a and fig. 4b, a plurality of third mark structures 50 are disposed on the third current-blocking film 66. As such, the plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 are not only capable of indicating the release configurations of the first occluding unit 22, the second occluding unit 24, and the waist 26, but also the configurations of the first flow-blocking membrane 62, the second flow-blocking membrane 64, and the third flow-blocking membrane 66. For example, it is indicated that the first flow blocking film 62, the second flow blocking film 64, and the third flow blocking film 66 are well spread without the curling phenomenon.

In one embodiment, as shown in fig. 2a, the first marker structure 30 is disposed on a surface of the first flow blocking film 62. As shown in fig. 3a, the second marker structure 40 is disposed on the surface of the second flow blocking film 64. As shown in fig. 4a, the third mark structure 50 is disposed on the surface of the third flow blocking film 66. The first marker structure 30, the second marker structure 40 and the third marker structure 50 may be secured to the first fluid barrier film 62, the second fluid barrier film 64 and the third fluid barrier film 66, respectively, by a fastening means such as an adhesive.

In one embodiment, referring to fig. 2b again, the first current blocking film 62 includes a first upper film 622 and a first lower film 624 stacked one on another, and the plurality of first mark structures 30 are disposed between the first upper film 622 and the first lower film 644. Referring to fig. 3b again, the second current blocking film 64 includes a second upper film 642 and a second lower film 644 which are stacked, and the plurality of second mark structures 40 are disposed between the second upper film 642 and the second lower film 644. Referring to fig. 4b again, the third current blocking film 66 includes a third upper film 662 and a third lower film 664 which are stacked, and the plurality of third mark structures 50 are disposed between the third upper film 662 and the third lower film 664. In one embodiment, the first marker structure 30 is secured to the first upper film 622 and/or the first lower film 624, the second marker structure 40 is secured to the second upper film 642 and/or the second lower film 644, and the third marker structure 50 is secured to the third upper film 662 and/or the third lower film 664 by thermal welding. The above arrangement can prevent the first marker structure 30, the second marker structure 40 and/or the third marker structure 50 from falling off. On one hand, the first marking structure 30, the second marking structure 40 and/or the third marking structure 50 can be prevented from falling off from the delivery sheath in the delivery process, so that the occluder 100 is invisible or has poor visibility under medical imaging equipment, thereby increasing the difficulty of the operation or preventing the operation from being performed; on the other hand, it is avoided that after implantation, the first marker structure 30, the second marker structure 40 and/or the third marker structure 50 fall off before endothelialisation, causing an uncontrolled risk.

In an embodiment, the first flow-blocking film 62, the second flow-blocking film 64, and the third flow-blocking film 66 are all single-layer structures, and the plurality of first marker structures 30, the plurality of second marker structures 40, and the plurality of third marker structures 50 are respectively disposed inside or on the surfaces of the first flow-blocking film 62, the second flow-blocking film 64, and the third flow-blocking film 66.

When the thickness of the first flow resistance film 62, the second flow resistance film 64, and the third flow resistance film 66 is greater than 0.6 mm, the thickness is too large, resulting in a large size of a required delivery sheath, thereby affecting delivery. When the thickness is less than 0.02 mm, the flow-resistant film is easily broken, for example, by stretching at the time of loading. Therefore, in one embodiment, the thickness of each of the first, second, and third flow-blocking

films

62, 64, and 66 is in the range of 0.02 to 0.6 mm, regardless of whether one or all of the first, second, and third flow-blocking

films

62, 64, and 66 are of a single-layer structure or a double-layer structure.

In one embodiment, when the occluding device 100 is placed in a stretched or partially stretched state (as shown in figure 5), the center of the first flow-blocking membrane 62 extends toward the distal end 101 of the occluding device 100 and the edges of the first flow-blocking membrane 62 contract to form a first pouch-like structure, with the first marker structure 30 being located inside the first pouch-like structure. The center of the second flow resistance membrane 64 extends in the distal direction 101 near the occluding device 100, and the edges of the second flow resistance membrane 64 contract to form a second pouch-like structure, with the second marker structure 40 being located inside the second pouch-like structure. The center of the third flow resistance membrane 66 extends towards the distal end 101 of the occluding device 100, and the edges of the third flow resistance membrane 66 contract to form a third pocket-like structure, and the third marker structure 50 is located inside the third pocket-like structure. In other embodiments, the center of the first flow-resistive membrane 62 extends in a direction towards the proximal end 102 of the occluding device 100 and the edges contract, the center of the second flow-resistive membrane 64 extends in a direction towards the proximal end 102 of the occluding device 100 and the edges contract, and the center of the third flow-resistive membrane 66 extends in a direction towards the proximal end 102 of the occluding device 100 and the edges contract.

Referring to fig. 5 and 6 together, when the occluding device 100 is loaded in the delivery sheath 200, the occluding device 100 is in a stretched state. The first marking structure 30, the second marking structure 40 and the third marking structure 50 are respectively located in the corresponding bag-shaped structures, and can be prevented from being in direct contact with the conveying sheath 200, so that the phenomenon that the first marking structure 30, the second marking structure 40 and the third marking structure 50 fall off due to friction and scratch between the first marking structure 30, the second marking structure 40 and the third marking structure 50 and the inner wall of the conveying sheath 200 is avoided.

In one embodiment, the first, second and third flow-blocking

membranes

62, 64, 66 are attached to the first and

second occluding units

22, 24 and the waist 26, respectively, by stitching.

In one embodiment, the first marker structure 30, the second marker structure 40 and the third marker structure 50 are each located within the respective pouch-like structure in a stretched condition by using a suitable stitching. For example, as shown in fig. 5, the first flow blocking membrane 62 is fixed inside the first occlusion unit 22 by using a first suture line 71 and a second suture line 72. The first sewing line 71 is closer to the center of the first flow blocking membrane 62 than the second sewing line 72. The second and third flow-blocking

membranes

64 and 66 are fixed in the same manner, and are not described in detail herein.

In one embodiment, the distance from the edge of each first mark structure 30 to the edge of the first flow blocking film 62 is 0 to 2 mm. The distance from the edge of each second mark structure 40 to the edge of the second flow blocking film 64 is 0-2 mm. The distance from the edge of each third mark structure 50 to the edge of the third flow resistance film 66 is 0-2 mm. The three distances are respectively set to be 0-2 mm, so that the limit positions of the first plugging unit 22, the second plugging unit 24 and the waist 26 can be identified conveniently, and accurate positioning of the plugging device 100 is facilitated.

In one embodiment, the distance from the edge of each first mark structure 30 to the edge of the first flow blocking film 62 is 1 to 2 mm. The distance from the edge of each second mark structure 40 to the edge of the second flow resistance film 64 is 1-2 mm. The distance from the edge of each third mark structure 50 to the edge of the third flow resistance film 66 is 1-2 mm. Therefore, the accurate positioning of the occluder 100 is facilitated, and the first marking structure 30, the second marking structure 40 and/or the third marking structure 50 are prevented from being easily scratched against the inner wall of the conveying sheath tube and falling off in the loading or conveying process.

In one embodiment, the number of the first mark structures 30 is at least 3, and in a natural state, the at least 3 first mark structures 30 are not in the same straight line. The number of the second mark structures 40 is at least 3, and in a natural state, at least 3 second mark structures 40 are not on the same straight line. The number of the third mark structures 50 is at least 3, and in a natural state, at least 3 of the third mark structures 50 are not in the same straight line. With such an arrangement, it is avoided that under the medical imaging device, the visibility of the entire shape of the occluding device 100 is affected by the overlapping of the first marker structures 30 as one point, the overlapping of the second marker structures 40 as one point, and the overlapping of the third marker structures 50 as one point, which is beneficial to the smooth operation.

When the number of marker structures is too large, on the one hand the costs are increased and on the other hand if the marker structures are made of a bio-non-absorbable material, this may lead to too much foreign body retention which may create a long-term clinical risk and may also affect the delivery performance. Therefore, in one embodiment, the number of the first mark structures 30 is 3 to 12, the number of the second mark structures 40 is 3 to 12, and the number of the third mark structures 50 is 3 to 12.

In one embodiment, at least 3 first marker structures 30 are uniformly distributed, at least 3 second marker structures 40 are uniformly distributed, and at least 3 third marker structures 50 are uniformly distributed. Taking the first mark structures 30 as an example, the uniform distribution means that the centers of the plurality of first mark structures 30 are connected to form a regular polygon or the distances between any two adjacent first mark structures 30 are equal. The uniform distribution of the plurality of second mark structures 40 and the uniform distribution of the plurality of third mark structures 50 have the same meaning, and are not described herein in detail.

In one embodiment, the number of the first mark structures 30 is three, and the centers of the three first mark structures 30 are connected to form a regular triangle. The number of the second mark structures 40 is three, and the centers of the three second mark structures 40 are connected to form a regular triangle. The number of the third mark structures 50 is three, and the centers of the three third mark structures 50 are connected to form a regular triangle. With this arrangement, using a minimum number of first marker structures 30, a minimum number of second marker structures 40 and a minimum number of third marker structures 50, it is possible to avoid excessive non-bioabsorbable foreign body residues and to avoid adversely affecting the delivery performance of the occluding device 100. Moreover, the projection form is not changed no matter the incident direction of the light source of the medical imaging device, and the form of the occluding device 100 can be judged according to the position of the mark structure and the length between the mark structures. Meanwhile, the operation is convenient, the excessive mandatory requirement on the incident direction of the light and shadow of the medical imaging equipment is not made, and the shortening of the operation time is facilitated.

Further, during the operation, when the first plugging unit 22 is released, a phenomenon that a part of the disc surface of the first plugging unit 22 or the second plugging unit 24 is stuck to the defect portion may occur, and the configuration of the occluder 100 can be determined by the position of the mark structure and the length between the mark structures no matter which portion is squeezed.

In one embodiment, the number of the first mark structures 30 is three, and the connecting lines of the three first mark structures 30 form a triangle. And, a central connecting line of the two first mark structures 30 passes through the center of the first flow blocking film 62, or a central connecting line of the two first mark structures 30 passes through the center of the first plugging unit 22. The number of the second mark structures 40 is three, and the centers of the three second mark structures 40 are connected to form a triangle. And, a line connecting centers of the two second mark structures 40 passes through the center of the second flow blocking film 64, or a line connecting centers of the two second mark structures 40 passes through the center of the second plugging unit 24. The number of the third mark structures 50 is three, and the centers of the three third mark structures 50 are connected to form a triangle. And wherein a line connecting the centers of two of the third marker structures 50 passes through the center of the third flow barrier film 66, or a line connecting the centers of two of the third marker structures 50 passes through the center of the waist 26. Thus, for the first mark structure 30 as an example, in a certain incident direction of the light shadow of the medical imaging apparatus, the difference between the length of the connection line (passing through the center) of the three first mark structures 30 and the width of the first flow-blocking film 62 (for example, when the first flow-blocking film 62 is circular, the width is a diameter, and when the first flow-blocking film 62 is elliptical, the width is the length of the major axis) is 0 to 2 mm. In this manner, edge formation at least at various portions of the frame 20 is further facilitated.

In one embodiment, the number of the first mark structures 30 is 2, and a central connecting line of two first mark structures 30 passes through the center of the first flow blocking film 62, or a central connecting line of two first mark structures 30 passes through the center of the first plugging unit 22. The number of the second mark structures 40 is 2, and a central connecting line of two second mark structures 40 passes through the center of the second flow blocking film 64, or a central connecting line of two second mark structures 40 passes through the center of the second plugging unit 24. The number of the third marker structures 50 is 2, and a line connecting the centers of two of the third marker structures 50 passes through the center of the third flow barrier film 66, or a line connecting the centers of two of the third marker structures 50 passes through the center of the waist 26.

In one embodiment, a plurality of first marker structures 30 are disposed on the first flow resistance film 62. A plurality of second marker structures 40 are disposed on the second flow resistance film 64. A plurality of third indicia structures 50 are disposed directly on the waist 26. The plurality of third marker structures 50 are wound around the threads of the waist portion 26, and the plurality of third marker structures 50 are disposed along the circumferential direction of the waist portion 26, and the plurality of third marker structures 50 are located on the same plane. Thus, the first plugging unit 22, the second plugging unit 24 and the waist can be well distinguished, and the support performance of the waist 26 is improved, so that the occluder 20 can be prevented from shifting under the impact of blood flow.

Referring again to fig. 5, in one embodiment, the occluding device 100 further comprises a distal end seal 80 and a distal marker structure 90 disposed on the distal end seal 80. The distal end seal 80 is connected to the first plugging unit 22 for fixing the free end of the wire of the first plugging unit 22.

In the natural state of the occluding device 100, the connecting line of the at least two first marker structures 30 and the distal marker structure 90 is triangular. During the operation, the height of the triangle will be decreased continuously to make the connecting lines of the at least two first marker structures 30 and the distal marker structure 90 become a straight line, which means that the adhesion between the occluder 100 and the defect site is good, and the pulling operation can be stopped to release the second occluding unit 24 of the occluder 100 continuously. The provision of the distal marker structure 90 facilitates further enhanced ease of operation.

The distal marker structure 90 may be different in visualization strength, visualization size, and/or visualization shape than the first marker structure 30 at the medical imaging device. The implementation of the difference in development strength and the difference in development size and development shape is the same as described above, and is not described here again.

The developing strength and/or the developing shape of the distal marker structure 90 and the first marker structure 30 under the medical imaging device are different, so that the distal marker structure 90 and the first marker structure 30 can be distinguished in the operation process, the height change of a triangle formed by connecting lines of the two first marker structures 30 and the distal marker structure 90 can be favorably judged, and the operation can be smoothly performed.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The occluder comprises an occluding frame and is characterized in that the occluding frame comprises a first occluding unit, a second occluding unit and a waist, two ends of the waist are respectively connected with the first occluding unit and the second occluding unit, a plurality of first mark structures are arranged on the first occluding unit, a plurality of second mark structures are arranged on the second occluding unit, a plurality of third mark structures are arranged on the waist, the central connecting lines of the plurality of first mark structures are straight lines under at least one incident direction of a light source under medical imaging equipment, the central connecting lines of the plurality of second mark structures are straight lines, the central connecting lines of the plurality of third mark structures are straight lines, and the plurality of first mark structures, the plurality of second mark structures and the plurality of third mark structures have different developing intensities under the medical imaging equipment, The development size is different and/or the development shape is different.

2. The occlusion device of claim 1, wherein the first, second, and third marker structures differ in material density and in thickness.

3. The occluder of claim 1 or 2, wherein the difference in thickness between the first, second and third marker structures is at least 80 microns when the densities of the materials of the first, second and third marker structures are different; and a minimum thickness of any of the first mark structure, the second mark structure, and the third mark structure is 70 micrometers.

4. The occluder of claim 1, wherein when the first, second and third marker structures differ in material density and in thickness, the first, second and third marker structures differ in surface area size by at least 0.2 square millimeters; and, any of the first, second, and third marker structures has a surface area of at least 0.2 square millimeters.

5. The occlusion device of claim 1, further comprising a first flow-impeding membrane disposed on the first occlusion unit, a second flow-impeding membrane disposed on the second occlusion unit, and a third flow-impeding membrane disposed on the lumbar region.

6. The occluder of claim 5, wherein said first flow-impeding membrane comprises a first upper membrane and a first lower membrane disposed in a stack, said plurality of first marker structures being disposed between said first upper membrane and said first lower membrane; the second flow blocking film comprises a second upper film and a second lower film which are arranged in a stacked mode, and the plurality of second mark structures are arranged between the second upper film and the second lower film; the third spoiler film includes a third upper film and a third lower film that are stacked, and the plurality of third mark structures are disposed between the third upper film and the third lower film.

7. The occluder of claim 5, wherein the distance from the edge of each of said first marker structures to the edge of said first flow-blocking membrane is in the range of 0 to 2mm, the distance from the edge of each of said second marker structures to the edge of said second flow-blocking membrane is in the range of 0 to 2mm, and the distance from the edge of each of said third marker structures to the edge of said third flow-blocking membrane is in the range of 0 to 2 mm.

8. The occluder of claim 5, wherein the center of the first flow-resistive membrane extends in a distal or proximal direction adjacent the occluder when the occluder is in a stretched state, and wherein the edges of the first flow-resistive membrane contract to form a first pouch-like structure, the first plurality of marker structures being located inside the first pouch-like structure; the center of the second flow-resisting film extends towards the far end direction or the near end direction of the occluder, the edge of the second flow-resisting film shrinks to form a second bag-shaped structure, and the plurality of second mark structures are positioned inside the second bag-shaped structure; the center of the third flow-resisting film extends towards the far end direction or the near end direction of the occluder, the edge of the third flow-resisting film shrinks to form a third bag-shaped structure, and the plurality of third mark structures are positioned inside the third bag-shaped structure.

9. The occlusion device of claim 1, wherein the number of the first marker structures is at least 3, and in a natural state, a line connecting the at least 3 first marker structures is a regular polygon;

10. The occlusion device of claim 1, further comprising a distal end cap connected to an end of the first occlusion unit distal to the waist, and a distal marker structure disposed on the distal end cap, wherein the distal marker structure and the first marker structure have different visualization strengths, visualization sizes, and/or visualization shapes under a medical imaging device.