CN113303859A

CN113303859A - Embolism material and preparation method thereof

Info

Publication number: CN113303859A
Application number: CN202110710914.7A
Authority: CN
Inventors: 张朔; 杨瑞; 蔡亮; 郭远益; 钱少君
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Shendun Medical Technology Shanghai Co ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2021-08-27
Anticipated expiration: 2040-12-31
Also published as: CN112641484A; WO2022142788A1; CN113303859B

Abstract

The invention relates to an embolus and a preparation method thereof, and the embolus comprises a tubular first spiral part with an inner cavity, a second spiral part nested on the outer side surface of the first spiral part, and a shaping part at least partially arranged in the inner cavity of the first spiral part, wherein the first spiral part comprises a radiopaque material, the second spiral part comprises a bioabsorbable material, and one end of the shaping part is fixed at one end of the first spiral part and one end of the second spiral part. The setting component is arranged in the embolus with the double-layer structure, so that the embolus not only has the performance of degrading and relieving the occupying effect, but also has the characteristics of better developing property, better supporting property and the like in the aneurysm.

Description

Embolism material and preparation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to an intravascular embolism object and a preparation method thereof.

Background

With the improvement of domestic living standard, the incidence of vascular diseases caused by abnormal changes of blood vessels or aging and other factors is also increasing year by year, and the manifestations of the diseases comprise intracranial aneurysm, visceral aneurysm, peripheral aneurysm, arteriovenous malformation, hemangioma and the like. For the diseases, the treatment schemes adopted at home and abroad mainly comprise surgical treatment and interventional treatment. Because of the great trauma and the series of complications associated with surgical treatments, minimally invasive endovascular procedures are increasingly favored by physicians and patients. For example, embolization of coils implanted in aneurysms or malformed vessels alters hemodynamics to achieve complete embolization or thrombosis for therapeutic purposes.

Presently, there are spring coils available on the market comprising: a pre-shaped bare metal spring ring, a biological modification spring ring with a surface covered by a biological active material and a high-expansibility hydrogel spring ring. Wherein, the bare metal spring ring Axis Prime adopts platinum-tungsten alloy material, and is prefabricated into a two-dimensional or three-dimensional structure for the use of embolism in the art. The biologically modified spring ring Matrix is characterized in that a layer of biological material of PLGA (polylactic-co-glycolic acid) material is covered on the surface of a metal ring, and the reduction of the space occupying effect is realized by utilizing the induced thrombosis and the biodegradability of the PLGA material. The hydrogel ring Hydrocoil is characterized in that hydrophilic polypropylene hydrogel is added into the metal ring, a large amount of water absorption volume of the hydrogel is expanded violently after the hydrogel ring is implanted, and the spring ring cavity is filled completely to reduce the recanalization rate of the aneurysm.

At present, degradable/absorbable coils are still in the conceptual stage and there are no mature products on the market. According to research, the coil made of absorbable bioactive materials generally has good X-ray permeability, so that the developing effect is poor in the actual pushing operation process, and the operation difficulty of a doctor is increased. In addition, few reports have proposed the addition of radiopaque elements to degradable coils, which are relatively complex structures and have relatively high difficulty in joining and securing the elements.

Therefore, a new embolus is needed to solve at least the above problems.

Disclosure of Invention

The invention provides an embolus and a preparation method thereof, wherein on the premise that the visibility meets the clinical requirement and the support and stability of the embolus in an aneurysm, at least part of the embolus can be gradually degraded and absorbed by an organism and converted into small molecular substances harmless to the organism, so that the effect of relieving the space occupying effect is achieved.

In order to achieve the above object, the present invention provides an embolus, which comprises a tubular first spiral part with an inner cavity, a second spiral part nested on the outer side surface of the first spiral part, and a shaping part at least partially arranged in the inner cavity of the first spiral part, wherein the first spiral part comprises a radio-opaque material, the second spiral part comprises a bioabsorbable material, and one end of the shaping part is fixed at one end of the first and second spiral parts.

Optionally, the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.

Optionally, the first helical member is a metal member made of one of platinum, iridium, gold, silver, tantalum, and tungsten, or an alloy thereof.

Optionally, the first spiral member is a composite material member in which a matrix is doped with a developing substance, wherein the developing substance is an iodine contrast agent or barium sulfate, and the matrix is one or more of polylactic acid, polyglycolic acid, a lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid.

Optionally, the second helical member is one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy.

Optionally, the shaping component comprises at least one shaping wire, wherein each shaping wire has a circular, elliptical or polygonal cross section.

Optionally, the material of the shaping component is one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

Optionally, the shaping member has at least one secondary structure of a spiral, a wave, a tetrahedron, a pentahedron, and a hexahedron.

Optionally, the second helical member has an outer diameter dimension in the range of 0.005-0.05 inches and a length dimension in the range of 0.5-200 centimeters, wherein a wire wound around the second helical member has a cross-section in the shape of a circle or a portion of a circle, the wire having a diameter or radius of curvature 2 times in the dimension range of 0.0005-0.005 inches.

Optionally, the first helical member has an outer diameter dimension in the range of 0.002-0.02 inches and a length that is 10% -100% of the length of the tubular structure around which the second helical member is wound, wherein the wire that winds the first helical member has a cross-section that is circular or a portion of a circle, and the wire has a diameter or radius of curvature that is 2 times the diameter of the wire in the range of 0.0003-0.003 inches.

Optionally, the sizing component comprises at least one sizing wire having a diameter of no more than 90% of the inner diameter of the first helical component.

Optionally, the first helical member, the second helical member and the sizing member are coaxial or axially parallel, and/or the axial length of the first helical member is no greater than the axial length of the second helical member.

Optionally, at least one end of the second spiral member forms a ball cap by hot melting or dispensing for end sealing, wherein at least a portion of the first spiral member covers the ball cap.

Optionally, one end of the shaping member is fixed to one end of the first and second spiral members by the ball cap.

Optionally, one end of the shaping component is provided with an inverted J-shaped hook, and at least part of the inverted J-shaped hook wraps the ball cap.

Optionally, the embolic material further comprises a fixation member disposed at least partially within the lumen of the first helical member, wherein the fixation member and the first helical member are coaxial or axially parallel.

Optionally, the fixing component is a polymer wire, wherein the material of which the polymer wire is made is one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, a lactic acid-glycolic acid copolymer, and polycaprolactone.

Optionally, the polymer wire is physically wound or knotted at both ends of the first and second spiral members to fix the first and second spiral members.

Optionally, the polymer filament winds together at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member to be knotted to maintain the first helical member and the second helical member coaxial or axially parallel.

Optionally, the embolus has at least one secondary structure of a helix, a wave, a tetrahedron, a pentahedron, and a hexahedron.

In order to achieve the above object, the present invention further provides an embolus, comprising a tubular first helical member having a lumen, a second helical member wound on an outer side of the first helical member, a shaping member at least partially disposed in the lumen of the first helical member, and a fixing member at least partially disposed in the lumen of the first helical member, wherein: the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material; the fixing parts are respectively connected to two ends of the second spiral part in a physical winding or knotting mode; one end of the shaping component is fixed at one end of the first spiral component and one end of the second spiral component; and at least one end of the second spiral component forms a spherical cap in a hot melting or dispensing mode for end sealing, and at least parts of the first spiral component and the shaping component are covered on the spherical cap.

In order to achieve the above object, the present invention also provides a method for preparing an embolus, which is characterized by comprising the following steps: pre-setting the wound first spiral component and the setting component on a die respectively according to a preset shape; arranging the pre-shaped shaping component in the inner cavity of the pre-shaped first spiral component; and sleeving the wound second spiral part outside the wound first spiral part.

Optionally, the method for preparing the embolus further comprises: disposing a fixation member in the lumen of the first helical member; connecting the fixing parts arranged in the inner cavity of the first spiral part to two ends of the first spiral part and the second spiral part respectively in a physical winding or knotting mode; and fixing one end of the shaping component and one end of the first and second spiral components together.

Optionally, the polymer filament is knotted to the first and second helical members in a manner such that the polymer filament simultaneously knots at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member to maintain the first and second helical members coaxial or axially parallel.

In conclusion, the embolus and the preparation method thereof provided by the invention have the following advantages:

first, the embolus adopts a double-layer structure of a bioabsorbable material and a metal nontransmissive material, so that the embolus can be partially degraded and absorbed within a certain time while the characteristics of better developing property, better supporting property and the like of the traditional metal spring ring are kept, and the problems of space occupation effect and the like which can cause compression of surrounding tissues and nerves to large-scale aneurysms can be effectively relieved.

Secondly, the setting component arranged in the double-layer spiral structure of the embolus not only has good visibility, but also has a three-dimensional presetting structure which can improve the stability of the embolus and ensure that the embolus has better support property in the aneurysm.

Drawings

FIG. 1 is a partial cross-sectional view of an embolic material according to an embodiment of the present invention;

FIG. 2 is a cross-sectional view of the plug shown in FIG. 1;

fig. 3 is a cross-sectional view of a plug according to another embodiment of the present invention.

[ reference numerals are described below ]:

10-an embolus; 100-a first helical member; 110-lumen; 120-a second helical member; 130-a shaping component; 132-a distal end of the styling member; 134-the proximal end of the styling member; 140-a distal end; 150-a ball cap; 160-a proximal end; 170-fixing the component.

Detailed Description

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 merely for the purpose of facilitating and distinctly claiming the embodiments of the present 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. The same or similar reference numbers in the drawings identify the same or similar elements.

Further, in the following description, for convenience of description, "distal" and "proximal" are used; "proximal" is the end proximal to the medical instrument operator; "distal end" is the end that is distal to the operator of the medical device. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the invention.

The core idea of the invention is to provide an embolus, which comprises a tubular first spiral part with an inner cavity, a second spiral part nested on the outer side surface of the first spiral part and a shaping part at least partially arranged in the inner cavity of the first spiral part, wherein the first spiral part comprises a radio-opaque material, the second spiral part comprises a bioabsorbable material, and one end of the shaping part is fixed at one end of the first spiral part and one end of the second spiral part. The first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.

In order to achieve the above object, the present invention further provides an embolus, comprising a tubular first helical member having a lumen, a second helical member wound on an outer side of the first helical member, a shaping member at least partially disposed in the lumen of the first helical member, and a fixing member at least partially disposed in the lumen of the first helical member, wherein:

the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material;

the fixing parts are respectively connected to two ends of the second spiral part in a physical winding or knotting mode;

one end of the shaping component is fixed at one end of the first spiral component and one end of the second spiral component; and

at least one end of the second spiral component forms a ball cap in a hot melting or dispensing mode for end sealing, and at least parts of the first spiral component and the shaping component are covered on the ball cap.

It is understood that the embolus of the present application may be a coil for use in the treatment of intracranial vascular diseases, such as intracranial aneurysms. In addition, the vascular implant can also be applied to the treatment of diseases such as non-intracranial vascular aneurysm and the like.

After the embolus is implanted into a focus for a period of time, the biological material in the double-layer structure can be gradually degraded and absorbed by an organism and converted into small molecular substances harmless to the organism, so that the effect of reducing the space occupying effect is achieved. In addition, the shaping component arranged in the double-layer spiral structure not only can improve the support and stability of emboli in the operation process, but also has certain ray visibility.

The embolus and the preparation method thereof provided by the invention are further described below by combining the attached drawings and a plurality of embodiments.

FIG. 1 is a partial cross-sectional view of an embolic 10 according to an embodiment of the present invention. Fig. 2 is a cross-sectional view of the plug 10 shown in fig. 1. With the plug 10 in its linear primary shape as shown, the plug 10 is an elongated device of greater length extending from its proximal end 160 to its distal end 140. The proximal end of the embolus 10 is arranged to be connected to a pushing device (not shown) of the embolus 10. The tampon 10 includes a tubular first helical member 100 having a lumen 110, a second helical member 120 nested on an outer side of the first helical member 100, and a shaping member 130 disposed at least partially within the lumen 110 of the first helical member 100. Wherein the first screw member 100, the second screw member 120 and the fixing member 130 are coaxial or axially parallel.

Wherein the first helical member 100 comprises a radiopaque material. In some embodiments, the first spiral member 100 is a metal member made of one of platinum, iridium, gold, silver, tantalum, and tungsten, or an alloy thereof, and a metal wire made of the above material is spirally wound on a core column of a predetermined diameter to form the first spiral member 100. The pitch of the coils of the first helical member 100 may be uniform, may be gradual along the length of the coils, or may have different pitches in different sections of the coils.

In some embodiments, the first helical member 100 is a composite member with a matrix doped with a developing substance, wherein the developing substance may be iodine contrast agent or barium sulfate, and the matrix may be one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid. The first helical member 100 is formed by helically winding a filament-like composite material member around a core rod of a predetermined diameter.

In some embodiments, the second helical member 120 comprises a bioabsorbable material, which may be one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy. In some embodiments, the second helical member 120 may be modified, for example, by loading some active substance, such as a growth factor or a drug molecule, into or on the surface of the second helical member 120. The second screw part 120 is spirally wound on a core column of a predetermined diameter by a polymer or metal wire made of the above material. It will be appreciated that the pitch of the coils of the second helical member 120 may be uniform, may be tapered along the length of the coils, or may have different pitches at different sections of the coils.

The volume of the second helical member 120, which is made of a bioabsorbable material, is in the range of 30% to 90% of the total volume of the entire tampon 10. The embolus 10 with the double-layer structure of the bioabsorbable material and the metal nontransmissive material is adopted, so that the characteristics of better developing property, better supporting property and the like of the traditional metal spring ring are kept, meanwhile, the bioabsorbable material part can be partially degraded and absorbed within a certain time, and the problems of space occupying effect and the like which can cause compression of surrounding tissues and nerves to large-scale aneurysms can be effectively relieved.

In some embodiments, the first helical member 100 has an outer diameter dimension in the range of 0.002 to 0.02 inches, and the wire wound around the first helical member 100 has a cross-section that is circular or a portion thereof, the wire having a diameter or radius of curvature that is 2 times the diameter or radius of curvature in the range of 0.0003 to 0.003 inches. The outer diameter of the second helical member 120 is in the range of 0.005-0.05 inches in size, and the wire wound around the second helical member 120 has a cross section of a circle or a portion of a circle having a size in the range of 0.0005-0.005 inches in diameter or 2 times the radius of curvature. With continued reference to fig. 1 and 2, the second helical member 120 wraps around the outside of the first helical member 100, and the axial length of the first helical member 100 is no greater than the axial length of the second helical member 120. The second helical member 120 has a length dimension in the range of 0.5-200 cm, and the first helical member 100 has a length slightly shorter than the length of the second helical member 120 and is 10-100% of the length of the tubular structure around which the second helical member 120 is wound.

As shown in fig. 2, the distal end 132 of the shaping member 130 is fixed to the distal ends 140 of the first and second

helical members

100, 120, and the proximal end 134 of the shaping member 130 is a free end and is disposed within the proximal lumen 110 of the first helical member 100. In one embodiment of the present application, the distal end 132 of the shaping member 130 is configured as an inverted J-shaped hook, which is connected to at least one coil, such as the last coil, of the distal end 140 of the first screw member 100, and then the distal ends 140 of the first and

second screw members

100 and 120 are formed into an atraumatic distal tip by heat-fusing or spot-gluing, so that the distal end 132 of the shaping member 130 and the distal ends 140 of the first and

second screw members

100 and 120 are firmly combined with each other, i.e., at least a portion of the inverted J-shaped hook and the distal ends 140 of the first and

second screw members

100 and 120 are wrapped around the atraumatic distal tip. The atraumatic distal tip may be a ball cap 150 as shown in fig. 2, or may be a conical or elliptical closed end. Wherein the atraumatic distal tip may be formed from a polymeric material, such as polyester, acrylic adhesive, or other polymeric materials suitable for hot melt or spot gluing. In other embodiments, the distal end 132 of the shaping member 130 can be connected to the distal ends 140 of the first and second

helical members

100, 120 by other means, such as, for example, a straight, inverted J, or other shaped shaping member 130 with the distal end 132 directly wrapped by the cap 150; or the distal end 132 of the shaping member 130 is connected to at least one coil of the second spiral member 120 and then wrapped and fixed by the ball cap 150; or the fixing member 130 is connected to at least one end of the first and

second spiral members

100 and 120 by physically winding or knotting the wire.

In some embodiments, the proximal end 134 of the sizing member 130 is connected to the proximal end 160 of the first helical member 100 and the distal end 132 is a free end. The proximal and

distal ends

134, 132 may also be connected to the proximal and

distal ends

160, 140, respectively, of the first helical member 100.

In some embodiments, the shaping member 130 comprises at least one shaping wire, wherein each shaping wire has a cross-section of a circle, ellipse, or polygon having a diameter of no more than 90% of the inner diameter of the first helical member 100, wherein the inner diameter of the first helical member 100 ranges from 0.001 to 0.01 inches. The material forming the shaping component 130 is a memory alloy, and may be one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy. The use of the above-mentioned material for the shaping member 130 not only enhances the visibility of the double-layer helical structure in the blood vessel and aneurysm, but also allows the memory alloy to be pre-shaped in a three-dimensional manner for improving the stability of the embolus 10, which may provide better support in the aneurysm. In some embodiments, the shaping member 130 may be pre-shaped to have at least one secondary structure of a spiral shape, a wave shape, a tetrahedron, a pentahedron, and a hexahedron.

Fig. 3 is a cross-sectional view of another embodiment of the tampon 10 of the present invention. The embolus 10 comprises a tubular first spiral member 100 with a cavity 110, a second spiral member 120 nested on the outer side of the first spiral member 100, a shaping member 130 at least partially arranged in the cavity 110 of the first spiral member 100, and a fixing member 170 at least partially arranged in the cavity 110 of the first spiral member 100. The first screw member 100, the second screw member 120 and the fixing member 130 have substantially the same structure and use as those of the embodiment shown in fig. 2, and a description thereof will not be repeated. In some embodiments, the fixation component 170 and the first helical component 100 are coaxial or axially parallel.

As shown in fig. 3, the fixing member 170 may be a polymer wire made of one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone. The polymer wire is attached to both ends of the first and

second spiral members

100 and 120, respectively, by physical winding or knotting, to fix the first and

second spiral members

100 and 120.

In some embodiments, the fixation element 170 is knotted to the first and second

helical elements

100, 120 in a manner such that the fixation element 170 simultaneously knots at least one turn of the helix on the first helical element 100 and at least one turn of the helix on the second helical element 120 to maintain the first and second

helical elements

100, 120 coaxial or axially parallel. It is to be understood that the coupling position of the fixing member 170 with the first screw member 100 and/or the second screw member 120 is not limited to that shown in fig. 3, and the fixing member 170 may be knotted at any position on the circumference of the screw member.

As shown in fig. 3, the fixing member 170 may be coupled to the fixing member 130 before being tied to the proximal end 140 of the first screw member 100, thereby stabilizing the fixing member 170, the first screw member 100 and the fixing member 130.

In some embodiments, the knotting of the fixing member 170 with the first and

second screw members

100 and 120 may also be: the fixing member 170 is knotted only to at least one turn of the spiral on the first spiral member 100 or at least one turn of the spiral on the second spiral member 120.

In order to achieve the above object, the present invention also provides a method for preparing the embolus 10, referring to fig. 3, which mainly comprises the following steps:

s1, pre-shaping the wound first spiral component 100 and the shaping component 130 on a mold according to a preset shape, wherein the preset shape may be at least one of spiral (helicoid), wave, tetrahedron, pentahedron and hexahedron, and the preset shapes of the first spiral component 100 and the shaping component 130 are corresponding to each other.

S2, the preset shaping member 130 is set in the cavity 110 of the preset first spiral member 100, that is, the filamentous shaping member 130 is inserted into the cavity 110 of the first spiral member 100, and at least one end of the shaping member 130 is fixed to at least one end of the first spiral member 100.

S3, the fixing member 170 is disposed in the lumen 110 of the first helical member 100.

S4, the wound second spiral member 120 is sleeved outside the wound first spiral member 100.

S5, the fixing members 170 disposed in the inner cavity 110 of the first spiral member 100 are respectively connected to the two ends of the first spiral member 100 and the second spiral member 120 by physically winding or knotting, and a spherical cap 150 is formed at least one end of the second spiral member 120 by hot melting or dispensing, wherein at least a portion of the first spiral member 100 and the shaping member 130 is wrapped around the spherical cap 150.

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 embolus comprising a tubular first helical member having a lumen, a second helical member nested outside the first helical member, and a sizing member disposed at least partially within the lumen of the first helical member, wherein the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material, the sizing member is secured at one end to one end of the first and second helical members, the second helical member has an outer diameter dimension in the range of 0.005-0.05 inch and a length dimension in the range of 0.5-200 cm, wherein a wire winding the second helical member has a cross-section that is a circle or a portion of a circle, and the wire has a diameter or radius of curvature that is 2 times the diameter of the wire in the range of 0.0005-0.005 inch.

2. The tampon of claim 1 wherein the first helical member is a metallic member made of any one of platinum, iridium, gold, silver, tantalum, and tungsten, or an alloy thereof.

3. The embolic material of claim 1, wherein said first helical member is a composite member having a matrix doped with a contrast material, wherein said contrast material is an iodine contrast agent or barium sulfate, and wherein said matrix is any one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid.

4. The embolic material of claim 1, wherein said second helical member is any one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy.

5. The embolus of claim 1, wherein the sizing component comprises at least one sizing wire, wherein each of the sizing wires has a cross-section that is circular, elliptical, or polygonal.

6. The embolus of claim 1, wherein the material of the shaped component is one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

7. The embolic material of claim 1, wherein said shaping member has a secondary structure of at least one of a spiral, a wave, a tetrahedron, a pentahedron, and a hexahedron.

8. The embolus of claim 1, wherein the outer diameter of the first helical member has a dimension in the range of 0.002-0.02 inch and a length of 10% -100% of the length of the tubular structure around which the second helical member is wound, and wherein the wire winding the first helical member has a cross-section that is a circle or a portion of a circle having a dimension in the range of 0.0003-0.003 inch which is 2 times the diameter or radius of curvature of the wire.

9. The embolus of claim 7, wherein the sizing component comprises at least one sizing wire having a diameter of no more than 90% of the inner diameter of the first helical component.

10. The embolic device of claim 1, wherein said first helical member, said second helical member, and said shaping member are coaxial or axially parallel, and/or wherein said first helical member has an axial length that is no greater than an axial length of said second helical member.

11. The embolic material of claim 1, wherein at least one end of the second helical member is terminated by forming a ball cap by hot-melt or spot-gluing, wherein at least a portion of the first helical member wraps around the ball cap.

12. The embolic device of claim 11, wherein said sizing member is secured at one end to one end of said first and second helical members by said spherical cap.

13. The embolic device of claim 11, wherein one end of said styling member is configured as an inverted J-shaped hook, at least a portion of said inverted J-shaped hook being wrapped around said spherical cap.

14. An embolus as defined in claim 1, further comprising a fixation element disposed at least partially within the lumen of the first helical element, wherein the fixation element and the first helical element are coaxial or axially parallel.

15. The embolus of claim 1, wherein the fixation component is a polymer wire, wherein the material from which the polymer wire is made is one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone.

16. The embolic material of claim 15, wherein said tubular polymer wire is physically wrapped or knotted at both ends of said first helical member and said second helical member, respectively, to secure said first helical member and said second helical member.

17. The embolus of claim 16, wherein the polymer wire wraps at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member together to tie off to maintain the first helical member and the second helical member coaxial or axially parallel.

18. The embolus of claim 1, wherein the embolus has at least one secondary structure of a helical, undulating, tetrahedral, pentahedral and hexahedral structure.

19. A method of preparing an embolus as claimed in any of claims 1 to 18 which comprises the steps of:

pre-setting the wound first spiral component and the setting component on a die respectively according to a preset shape;

arranging the pre-shaped shaping component in the inner cavity of the pre-shaped first spiral component; and

and sleeving the wound second spiral part outside the wound first spiral part.

20. The method of claim 19, further comprising:

disposing a fixation member in the lumen of the first helical member;

connecting the fixing parts arranged in the inner cavity of the first spiral part to two ends of the first spiral part and the second spiral part respectively in a physical winding or knotting mode; and

and fixing one end of the shaping component and one ends of the first spiral component and the second spiral component together.

21. The method of manufacturing of claim 20, wherein said polymer filament is knotted to said first helical member and said second helical member in a manner that said polymer filament simultaneously knots at least one turn of a helix on said first helical member and at least one turn of a helix on said second helical member to maintain said first helical member and said second helical member coaxial or axially parallel.