CN115137428A

CN115137428A - Plugging device and plugging system

Info

Publication number: CN115137428A
Application number: CN202110336294.5A
Authority: CN
Inventors: 屠春霖; 张博纬; 陈伊璐; 薛彦慧; 刘金宏; 朱清
Original assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Current assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Priority date: 2021-03-29
Filing date: 2021-03-29
Publication date: 2022-10-04
Also published as: AR125611A1; WO2022206419A1

Abstract

The invention provides an occluder and an occlusion system, wherein the occlusion system comprises the occluder and a bracket; the stent is implanted into the true cavity of the aortic dissection and is provided with pores; the occluder comprises an anchoring portion and an embolism portion which are axially connected, the anchoring portion comprises a first spring coil assembly, the embolism portion comprises a second spring coil assembly, the embolism portion is used for penetrating through a pore on the stent and further extending into a false cavity from a crevasse of an aortic dissection, the anchoring portion is arranged in an inner cavity of the stent and enables the occluder to be connected to the stent. The plugging system can avoid dislocation or displacement of the plugging device, also avoid secondary damage to the vessel wall and has better treatment effect.

Description

Plugging device and plugging system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an occluder and an occlusion system.

Background

The aortic dissection refers to a true-false two-lumen separation state that blood in an aortic lumen enters an aortic media from an aortic intimal tear part, so that the media is separated and expands along the major axis direction of the aorta to form an aortic wall. At present, the treatment method aiming at the aortic dissection mainly comprises an aortic intracavitary repair operation (EVAR), wherein a tectorial membrane stent is generally adopted to block the lacerations of the dissection, reconstruct a true lumen vascular access and reduce the blood flow of a false lumen so as to ensure the thrombosis of the false lumen.

The EVAR is primarily proximal-covered, or extended to the distal end. For distal lacerations of aortic dissection, the currently used treatment methods are mainly by contemporaneous or staged treatment to achieve more optimal aortic remodeling. However, in clinical studies, the number of lacerations at the distal end of the aortic dissection is large, the pathology is complex, and the distal ends of the dissections of most patients have more than three lacerations, so that the treatment is difficult. Meanwhile, most of the distal lacerations are located in the visceral organ area of the abdominal aorta, and branch arteries exist in the visceral organ area, so that intracavity treatment is difficult. Also, due to the presence of the distal lacerations, ideal thrombogenicity of the false lumen is difficult to achieve, and some patients develop and continue to grow in false lumens and form aneurysms, even ruptures.

In view of this, it is common in the art to employ false lumen tamponade to promote false lumen thrombolysis. The false cavity is clogged to art usable spring coil and is clogged, because the distal end breach of false cavity is many, and intracavity volume is big, needs to use a large amount of spring coils to reach the compact packing clinically, leads to clinical operation difficulty and produces high medical expense, moreover, does not have fixing device after traditional spring coil release, has the aversion risk in the false cavity, reduces the treatment success rate. Some improved spring coils are connected to the naked support in advance and are synchronously conveyed to the body along with the naked support to be released, however, the spring coils of the type have large conveying resistance during conveying and are easy to wind during releasing, the positioning accuracy of the spring coils is influenced, the coiling form of the spring coils is uncontrolled and loose, the spring coils cannot be coiled at the crevasses, and the plugging effect of the spring coils at the crevasses is reduced. In other improved spring ring structures, the spring ring is connected to the bare stent through the anchoring hook after being released, but the anchoring hook is easy to misplace and deviate from a preset position, and the anchoring hook is also easy to damage the blood vessel wall, so that secondary damage is caused to the blood vessel wall.

Disclosure of Invention

The invention aims to provide an occluder and an occlusion system, wherein the occluder can be accurately released at a preset position and firmly anchored, and can be prevented from long-term displacement and damage to a blood vessel wall is avoided.

In order to achieve the above object, the present invention provides an occluder comprising an axially connected anchoring portion and a plug portion, the anchoring portion comprising a first spring coil assembly, the plug portion comprising a second spring coil assembly.

Optionally, the first spring coil assembly comprises a first sizing wire that is a resilient wire and configured to have a first predetermined shape and a first spring coil that is sleeved over the first sizing wire and forms the first spring coil assembly into the first predetermined shape; and/or the presence of a gas in the gas,

the second spring coil subassembly includes the second and stereotypes silk and second spring coil, the second is stereotyped the silk and is configured to have the predetermined shape of second for having the wire of resilience, the second spring coil suit is in on the second is stereotyped the silk and is made the second spring coil subassembly forms the predetermined shape of second.

Optionally, the occluder further comprises a developing element disposed at a boundary region of the anchor portion and the plug portion; and/or the developing element is disposed on the anchor portion and the plug portion.

Optionally, the axial dimension of the first spring coil assembly is less than or equal to the axial dimension of the second spring coil assembly.

Optionally, the strength of the first spring coil assembly is greater than the strength of the second spring coil assembly.

Optionally, first design silk with the second design silk is the same kind of material, just the diameter of first design silk is greater than the diameter of second design silk is so that the intensity of first spring coil assembly is greater than the intensity of second spring coil assembly.

Optionally, the first sizing wire has a diameter of 0.008inch to 0.020inch, and the second sizing wire has a diameter of 0.005inch to 0.012inch.

Optionally, the first predetermined shape is any one of a spiral, a cone, a sphere, or a hexahedron; and/or the second predetermined shape is any one of a spiral shape, a cone shape, a sphere shape, or a hexahedron shape.

Optionally, when the first predetermined shape is a cone, the cross-section of the cone gradually increases in a direction away from the plug portion; and/or, when the second predetermined shape is a taper, the cross-section of the taper gradually increases in a direction away from the anchor portion.

Optionally, the plug portion further comprises a thrombogenic nap, the thrombogenic nap being attached to the secondary spring coil assembly.

To achieve the above object, the present invention further provides an occlusion system comprising a stent and at least one occluder according to any of the preceding claims, the plug portion being adapted to pass through an aperture in the stent and extend outside the stent, the anchor portion being adapted to be disposed in a lumen of the stent and to attach the occluder to the stent.

Compared with the prior art, the plugging device and the plugging system have the following advantages:

the plugging system comprises a plugging device and a support, wherein the plugging device comprises an axially connected plugging portion and an anchoring portion, the anchoring portion comprises a first spring ring assembly, the plugging portion comprises a second spring ring assembly, when the plugging system works, the plugging portion penetrates through a hole in the support and extends to the outside of the support so as to extend into a crevasse of an aortic dissection to plug the crevasse, and the anchoring portion is arranged in an inner cavity of the support and enables the plugging device to be connected to the support under the action of the first spring ring assembly. The first spring ring assembly is used for positioning the occluder on the stent and keeping the occluder at a preset position, so that the occluder can be prevented from being misplaced to hook other parts of the stent and cannot cause secondary damage to blood vessels.

Further, the first spring coil assembly includes a first shaping wire that is a resilient wire and configured to have a predetermined shape, and a first spring coil that is sleeved over the first shaping wire to form the anchor into the predetermined shape. The shape of the anchoring portion is maintained by the first shaping wire, so that the occluder can be effectively connected to the stent without displacement. Furthermore, the plug portion has a similar configuration such that the second spring ring of the plug portion is effectively coiled at the breach to effectively seal the breach.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 is a cross-sectional view of a blood vessel in a patient in the region of aortic dissection;

figure 2 is a schematic view of an occluder in accordance with an embodiment of the present invention;

figure 3 is a schematic diagram of an occluding device according to one embodiment of the invention, wherein the shape of the plug portion is different from the shape of the plug portion of the occluding device shown in figure 2;

FIG. 4 is a schematic view of a use scenario of the occluding device shown in FIG. 2;

FIG. 5 is a schematic view of the use of the occluding device shown in FIG. 3;

fig. 6 is a schematic structural view of the plug portion of the occluder according to an embodiment of the present invention, in which the plug portion is stretched in a linear state.

FIG. 7 is a schematic diagram of a first shaped wire of the occluding device according to the embodiment of the invention;

FIG. 8 is a schematic structural view of a first shaped wire of the occluding device according to the embodiment of the present invention, wherein the first shaped wire has a first predetermined shape and the first predetermined shape is a cone shape;

figure 9 is a schematic view of a primary coil of the occluding device according to an embodiment of the present invention, wherein the primary coil is stretched to a linear state;

figure 10 is a schematic view of the primary coil assembly of the occluding device according to the embodiment of the present invention, wherein the primary coil assembly is tapered.

[ reference symbols are explained below ]:

10-true lumen, 20-false lumen, 30-laceration;

100-occluder, 110-anchoring portion, 111-first shaping wire, 112-first spring ring, 120-plug portion, 121-second shaping wire, 122-second spring ring, 123-thrombus-promoting floss, 130-developing element;

200-bracket.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is provided for the purpose of facilitating and clearly illustrating embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Fig. 1 shows a cross-sectional view of a blood vessel in a region where aortic dissection occurs in a patient, fig. 2 and 3 are schematic structural views of an occluder 100 provided in an embodiment of the present invention, and fig. 4 and 5 are schematic usage views of the occluder 100.

As shown in fig. 1, when aortic dissection occurs in a patient, an aortic intima tears, so that media separates to form a true lumen 10 and a false lumen 20in a blood vessel, and the true lumen 10 and the false lumen 20 communicate through a laceration 30. It is an object of an embodiment of the present invention to provide an occluding device 100 (as shown in fig. 2 and 3), wherein the occluding device 100 can be used to occlude the prosthetic lumen 20 and the laceration 30 in the treatment of aortic dissection to block blood flow into the prosthetic lumen 20 and promote thrombosis of the prosthetic lumen 20 (as shown in fig. 4 and 5).

Referring to fig. 2 and 3, the occluding device 100 comprises an anchoring portion 110 and an embolizing portion 120 which are connected with each other, wherein the anchoring portion 110 and the embolizing portion 120 both comprise a spring coil assembly, hereinafter, the spring coil assembly of the anchoring portion 110 is referred to as a first spring coil assembly, and the spring coil assembly of the embolizing portion 120 is referred to as a second spring coil assembly. The occluding device 100 can be used in conjunction with a stent 200 for treatment of aortic dissection, the stent 200 being a bare stent with pores formed therein. Referring to fig. 4 and 5, in operation, the stent 200 is implanted in the true lumen 10 of the aorta, and the embolic portion 120 of the occluding device 100 passes through the pores of the stent 200 and extends out of the stent 200, thereby extending into the prosthetic lumen 20 from the laceration 30 and occluding the laceration 30. The anchoring portion 110 is disposed in the lumen of the stent 200 and connects the occluding device 100 to the stent 200 by the first spring coil assembly. In this embodiment, the stent 200 is delivered and released in the main lumen 10 of the aorta, and then the occluding device 100 is delivered and released, and the two are delivered separately, so that the delivery resistance is reduced, the blood vessel can be easily passed through, and the first spring coil assembly is used for anchoring the occluding device 100, thereby avoiding the dislocation thereof, improving the positioning accuracy, and avoiding the damage to the blood vessel wall. In an embodiment of the present invention, in order to maintain the anchoring portion 110 in the lumen of the stent 200, the cross-sectional area of at least a partial region of the first spring coil assembly may be larger than the area of the aperture. Furthermore, the connection direction of the plug portion 110 and the anchoring portion 120 (i.e. the direction from the plug portion 110 to the anchoring portion 120, or the direction from the anchoring portion 120 to the plug portion 110) is defined herein as the axial direction of the occluder 100.

Preferably, the first spring coil assembly includes a first shaping wire 111 and a first spring coil 112, the first shaping wire 111 is a resilient wire and is configured to have a first predetermined shape, and the first spring coil 112 is fitted over the first shaping wire and forms the first spring coil assembly into the first predetermined shape. Similarly, the second spring coil assembly may have a similar configuration to the first spring coil assembly. Specifically, the second spring coil assembly includes second stock wire 121 and second spring coil 122, second stock wire 121 is for having the wire of resilience and is configured to have the predetermined shape of second, second spring coil 122 suit is in on the second stock wire 121 and makes the second spring coil assembly forms the predetermined shape of second. During delivery of the occluding device 100 into a blood vessel, the first and second spring coil assemblies are generally stretched into a straight configuration, and when the occluding device 100 is released in the blood vessel, the first spring coil assembly returns to the first predetermined shape under the resilient force of the first shaping wire 111 and the second spring coil assembly returns to the second predetermined shape under the resilient force of the second shaping wire 121. That is, the shape of the first coil assembly is maintained by the first shaping wires 111 in the present embodiment, and the occluding device 100 is effectively attached to the stent 200 to avoid displacement. And the shape of the second spring coil assembly is also maintained by the second sizing wire 121, so that the second spring coil assembly is coiled at the crevasses 30 to effectively seal the crevasses 30 and promote the thrombosis of the false cavity. The specific shape and forming method of the first spring coil assembly and the second spring coil assembly will be described later.

The anchoring portion 110 is configured to be disposed in the lumen of the stent 200, i.e., the anchoring portion 110 is retained in the true lumen 10 of the aorta, in which case the primary spring coil assembly should be minimized in size to minimize the possibility of thrombus formation while ensuring that the occluding device 100 is effectively attached to the stent 200 (i.e., the primary spring coil assembly cannot pass through the pores of the stent 200). Typically, the axial dimension of the secondary spring coil assembly is greater than or equal to the axial dimension of the primary spring coil assembly to facilitate thrombolysis of the prosthetic lumen 20.

With continued reference to figures 2 and 3, the embolic portion 120 further comprises thrombogenic hairs 123, the thrombogenic hairs 123 are attached to the secondary spring coil assembly to increase the filling area of the occluding device 100 to promote thrombolysis of the prosthetic cavity 20. The material of the thrombus-promoting floss 123 can be at least one of high polymer materials such as polyethylene terephthalate (PET), polyamide (PA), polyethylene (PE), polypropylene (PP), polyurethane (PU) or polylactic acid (PLA). The thrombus-promoting hair 123 (fig. 6) is formed by making a Fully Drawn Yarn (FDY) or a Draw Textured Yarn (DTY) of 300-700D, winding two to three turns of the second shaping yarn 121, and clamping and positioning the two adjacent turns of the second coil 122. On the embolism portion 120, the embolism promotion villi 123 are arranged along the axial interval of the second sizing silk 121, and the axial interval between two adjacent embolism promotion villi 123 is 5mm-10mm. In addition, the length of each of the thrombogenic piles 123 (the length of the thrombogenic piles 123 from the connection point on the first styling wire 111 to the free end of the thrombogenic pile 123) is 15mm to 25mm.

Further, the strength of the first spring coil assembly is greater than that of the second spring coil assembly, so that the anchoring portion 110 can provide sufficient anchoring performance. In one embodiment that can achieve this objective, the first shaping wire 111 and the second shaping wire 121 are made of the same material, and the diameter of the first shaping wire 111 is larger than that of the second shaping wire 121. Specifically, the first sizing wire 111 may have a diameter of 0.008inch to 0.020inch, and the second sizing wire may have a diameter of 0.005inch to 0.012inch.

With continued reference to fig. 2 and 3, the occluding device 100 further comprises a visualization element 130, wherein the visualization element 130 is used for positioning the embolic portion 120 and the anchoring portion 110 of the occluding device 100 in the body. In some embodiments, the number of the developing elements 130 may be at least one, and is disposed at the boundary area between the plug portion 120 and the anchoring portion 110, so that when the developing elements 130 are located at the crevasses 30, it is determined that the plug portion 120 enters the dummy cavity 20, and the anchoring portion 110 remains in the inner cavity of the stent 200. It should be understood that the boundary region may be a boundary between the plug portion 120 and the anchor portion 110, or may have a certain length. In other implementations, the number of the developing elements 130 is at least two, and at least two developing elements 130 are respectively disposed on the plug portion 120 and the anchor portion 110. Of course, when there are three or more developing elements 130, they may be disposed in the anchor portion 110, the plug portion 120, and the boundary area therebetween.

The specific shape and manufacturing process of the first spring coil assembly and the second spring coil assembly are described next. It can be understood that the first shaping wire 111 and the second shaping wire 121 may be connected to each other by welding after being formed in a split manner, or may be directly formed in an integrated manner; similarly, the first spring ring 112 and the second spring ring 121 may be formed separately or integrally directly, which is not limited in the embodiment of the present invention.

Referring to fig. 7, the first shaped wire 111 may be made of shape memory alloy such as nitinol, copper-nickel alloy, copper-zinc alloy, cobalt-chromium alloy or stainless steel alloy. The first shaping wire 111 is coiled to take the first predetermined shape and is heat treated to make the first shaping wire 111 have the first predetermined shape in a natural state. When the first shaping wire 111 is subjected to an external force, the shape of the first shaping wire 111 may be changed (e.g., stretched), but when the external force is removed, the first shaping wire 111 may return to the first predetermined shape.

Preferably, the first shaped wire 111 is coiled into a continuous and smooth curved structure, so that when the first spring coil assembly is finally formed, the first spring coil assembly has no sharp break angle, and the occurrence of secondary injury caused by scratch to blood vessels when the blood vessels are implanted is avoided. The specific shape of the curve structure is determined according to the first preset shape. In embodiments of the present invention, the first predetermined shape may be a cone (as shown in fig. 8), a spiral, a sphere, a hexahedron, or any other suitable shape. It will be appreciated that when the first predetermined shape is a cone, the cross-section of the cone increases progressively in a direction away from the plug portion 120. In addition, the conical, spherical and hexahedral shapes described herein include conical, spherical and hexahedral shapes in the geometric sense, and also include the substantially conical, spherical and hexahedral shapes.

The first spring coil 112 is formed by spirally winding a metal wire around a mandrel in a spring configuration, and then heat setting both ends of the metal wire (as shown in fig. 9). The first spring ring 112 can be made of nickel-titanium wire, platinum-tungsten wire, stainless steel wire, etc.

Then, an external force is applied to the first shaping wire 111, the first shaping wire 111 in the first predetermined shape is stretched, and the first coil spring 112 is sleeved on the first shaping wire 111. After the external force is removed, the first shaping wire 111 returns to the first predetermined shape by its own resilient force, so that the first spring coil assembly having the first predetermined shape is obtained (when the first predetermined shape is a cone, the structure of the first spring coil assembly is as shown in fig. 10). Preferably, both ends of the first coil 112 are further connected to the first shaping wire 111, respectively, to prevent the first coil 112 from unwinding during the release of the occluding device 100.

The specific shape and manufacturing process of the first spring coil assembly are described as an example, but those skilled in the art can modify the spring coil assembly to adapt to the specific shape and manufacturing process of the second spring coil assembly. That is, the material of the second shaping wire 121 may be the same as the material of the first shaping wire 111, and the second predetermined shape may be a spiral shape, a cone shape, a sphere shape, a hexahedron shape, or any other suitable shape. After the second predetermined shape is determined, the second sizing wire 121 is coiled into the second predetermined shape, and then the second spring coil 122 is sleeved on the stretched second sizing wire 121, so that when the second sizing wire 121 is restored to the second predetermined shape, the second spring coil assembly in the second predetermined shape is obtained. Likewise, when the second predetermined shape is a taper, the cross-section of the taper gradually increases in a direction away from the anchor portion 110.

In addition, for first design silk 111 with second design silk 121 integrated into one piece, and first spring coil 112 with second spring coil 122 integrated into one piece's the condition, with the design silk of integral type (include first design silk 111 with the partly coiling of second design silk 121) is first predetermined shape, another part is coiled into behind the second predetermined shape, with the whole back of stretching straight of design silk, again with the spring coil of integral type (including first spring coil 112 and second spring coil 122) suit at the design silk on, cancel and apply the effort on the design silk so that after the initial shape was restoreed to the design silk, obtain simultaneously first spring coil subassembly with second spring coil subassembly.

Referring back to fig. 4 and 5, an embodiment of the present invention further provides a plugging system, including the above-mentioned plugging device 100 and a stent 200, where the stent 200 is a generally metal bare stent having pores, the plug portion 120 of the plugging device 100 is used to pass through the pores and extend out of the stent 200, and further extend into the prosthetic cavity 20 from the crevasse 30 of the aortic dissection and plug the crevasse 30, and the anchor portion 110 is disposed in the lumen of the stent 200, and connects the plugging device 100 to the stent 200, so as to prevent the plugging device 100 from displacing and affecting the plugging effect.

In the aortic dissection treatment, the stent 200 is first delivered and released into the true lumen 10 of the aorta. The occluding device 100 is then implanted in the blood vessel using an introducer device. In the process of conveying the occluding device 10 by the introduction device, the first spring coil assembly and the second spring coil assembly are stretched. When the distal end of the introduction device passes through the pores of the stent 200 and the aortic dissection 30 and into the prosthetic lumen 20, it is determined from the display of the visualization element 130 that the embolic portion 120 has entered the prosthetic lumen 20 and the anchor portion 110 remains in the inner lumen of the stent 200, the release of the occluding device 200 can begin. After the release is completed, the plug portion 120 is retained in the false lumen 20, and the secondary spring coil assembly is coiled at the laceration 30 to close the laceration, and the primary spring coil assembly of the anchor portion 110 is coiled and retained in the lumen of the stent 200 by the stent edges of the aperture edge of the stent 200.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. An occluder comprising an axially connected anchoring portion comprising a first spring coil assembly and an embolizing portion comprising a second spring coil assembly.

2. The occluding device of claim 1, wherein the primary spring coil assembly comprises a primary sizing wire that is a resilient wire and configured to have a first predetermined shape and a primary spring coil that is nested over the primary sizing wire and forms the primary spring coil assembly into the first predetermined shape; and/or the presence of a gas in the atmosphere,

3. The occluder of claim 1 or 2, further comprising a visualization element disposed at a boundary region of the anchor portion and the plug portion; and/or the developing element is disposed on the anchor portion and the plug portion.

4. The occlusion device of claim 1 or 2, wherein the axial dimension of the first spring coil assembly is less than or equal to the axial dimension of the second spring coil assembly.

5. The occlusion device of claim 2, wherein the strength of the first spring coil assembly is greater than the strength of the second spring coil assembly.

6. The occlusion device of claim 5, wherein the first sizing wire and the second sizing wire are of the same material, and the diameter of the first sizing wire is greater than the diameter of the second sizing wire such that the strength of the first spring coil assembly is greater than the strength of the second spring coil assembly.

7. The occluder of claim 6, wherein said first sizing wire has a diameter of 0.008inch to 0.020inch and said second sizing wire has a diameter of 0.005inch to 0.012inch.

8. The occluder of claim 2, wherein said first predetermined shape is any of a helical, conical, spherical or hexahedral shape; and/or the second predetermined shape is any one of a spiral shape, a cone shape, a sphere shape, or a hexahedron shape.

9. The occlusion device of claim 8, wherein when the first predetermined shape is a taper, the taper increases in cross-section in a direction away from the plug portion; and/or, when the second predetermined shape is a taper, the cross-section of the taper gradually increases in a direction away from the anchor portion.

10. The occlusion device of claim 1, wherein the embolic portion further comprises embolic fluff attached to the secondary coil assembly.

11. An occlusion system comprising a stent and at least one occluder of any of claims 1-10, said plug portion adapted to pass through an aperture in said stent and extend outside of said stent, said anchor portion adapted to be disposed in a lumen of said stent and to attach said occluder to said stent.