CN113303859B

CN113303859B - Embolic material and preparation method thereof

Info

Publication number: CN113303859B
Application number: CN202110710914.7A
Authority: CN
Inventors: 张朔; 杨瑞; 蔡亮; 郭远益; 钱少君
Original assignee: Shendun Medical Technology Shanghai Co ltd
Current assignee: Shendun Medical Technology Shanghai Co ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2023-06-30
Anticipated expiration: 2040-12-31
Also published as: WO2022142788A1; CN113303859A; CN112641484A

Abstract

The invention relates to an embolic material and a preparation method thereof, comprising 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 on one end of the first spiral part and one end of the second spiral part. The shaping component is arranged in the embolic material with the double-layer structure, so that the embolic material not only has the performance of degrading and relieving the occupying effect, but also has the characteristics of good developing property, good supporting property and the like in the aneurysm.

Description

Embolic material and preparation method thereof

Technical Field

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

Background

Along with the improvement of domestic living standard, the incidence rate of vascular diseases caused by abnormal changes or aging of blood vessels and other factors is also increasing year by year, and the manifestations include intracranial aneurysms, visceral aneurysms, peripheral aneurysms, arteriovenous malformations, hemangiomas and the like. Aiming at the diseases, the treatment schemes adopted at home and abroad are mainly surgical treatment and interventional treatment. Due to the great trauma and a series of complications associated with surgical treatments, the approach of endovascular minimally invasive treatments is becoming increasingly favored by doctors and patients. For example, implantation of coils in aneurysms or malformed vessels to embolize changes in blood flow dynamics, to achieve complete embolization or thrombosis for therapeutic purposes.

Today, the coils available on the market comprise: a preformed bare metal spring coil, a biologically modified spring coil with a surface covered with a biologically active material, and a highly swellable hydrogel spring coil. The bare metal spring ring Axium Prime is made of a platinum-tungsten alloy material, and is prefabricated into a two-dimensional or three-dimensional structure for embolization in operation. The biological modified spring ring Matrix is characterized in that the surface of a metal ring is covered with a layer of biological material of PLGA (polylactic acid-glycolic acid copolymer) material, and the reduction of the occupying effect is realized by utilizing the induced thrombosis and the biodegradability of the PLGA material. Hydrogel ring hydro-gel through adding hydrophilic polypropylene hydrogel in the metal circle inside, hydrogel is in large amount and absorbs water volume and expands violently after the implantation, fills the spring ring intracavity completely to reduce the recanalization rate of aneurysm.

At present, degradable/absorbable coils are still in the conceptual stage and no mature product is yet marketed. According to investigation, the spring ring made of absorbable bioactive materials is usually good in X-ray permeability, so that the developing effect is poor in the actual pushing operation process, and the operation difficulty of doctors is increased. In addition, few reports have proposed the addition of radiopaque elements to degradable coils, which are relatively complex in construction and relatively difficult to connect and secure between the elements.

Thus, there is a need for a new embolic material that addresses at least the above-described problems.

Disclosure of Invention

The invention provides an embolic material and a preparation method thereof, and the embolic material can be gradually degraded and absorbed by an organism and converted into small molecular substances harmless to the organism on the premise that the embolic material meets clinical requirements and has supportability and stability in an aneurysm, thereby playing a role in relieving the occupying effect.

To achieve the above object, the present invention provides an embolic comprising a tubular first helical member having an inner lumen, a second helical member nested on an outer side of the first helical member, and a shaping member at least partially disposed within the inner lumen of the first helical member, wherein the first helical member comprises a radiopaque material, the second helical member comprises a bioabsorbable material, and one end of the shaping member is secured to one end of the first and second helical members.

Optionally, the first helical member comprises a radio-opaque material and the second helical member comprises a bioabsorbable material.

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

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

Optionally, the second spiral component 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 member 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 in the range of 0.005-0.05 inches and a length in the range of 0.5-200 cm, wherein the cross-section of the wire around which the second helical member is wound is circular or a portion of a circle, and the wire has a diameter or radius of curvature in the size range of 2 times the diameter or radius of curvature of 0.0005-0.005 inches.

Optionally, the first spiral member has an outer diameter ranging from 0.002 to 0.02 inches and a length ranging from 10% to 100% of the length of the tubular structure wound by the second spiral member, wherein the wire wound around the first spiral member has a circular or a portion of a circular cross section, and the wire has a diameter or radius of curvature ranging from 0.0003 to 0.003 inches in size.

Optionally, the shaping member comprises at least one shaping wire having a diameter not exceeding 90% of the inner diameter of the first helical member.

Optionally, the first screw member, the second screw member and the shaping member are coaxial or axially parallel, and/or the axial length of the first screw member is not greater than the axial length of the second screw member.

Optionally, at least one end of the second spiral component is capped by forming a spherical cap through hot melting or dispensing, wherein at least part of the first spiral component is coated on the spherical cap.

Optionally, one end of the shaping member is fixed to one end of the first and second screw members through the 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 is covered on the spherical cap.

Optionally, the embolic material further comprises 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.

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

Optionally, the polymer wires are connected to two ends of the first spiral part and the second spiral part by physical winding or knotting, so as to fix the first spiral part and the second spiral part.

Optionally, the polymer filament twines 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 knot the first helical member and the second helical member to maintain the first helical member and the second helical member coaxial or axially parallel.

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

To achieve the above object, the present invention also provides an embolic comprising a tubular first helical member having an inner lumen, a second helical member wound around the outer side of the first helical member, a shaping member at least partially disposed within the inner lumen of the first helical member, and a fixation member at least partially disposed within the inner 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 the two ends of the second spiral part in a physical winding or knotting mode; one end of the shaping component is fixed at one ends of the first spiral component and the second spiral component; and at least one end of the second spiral part is blocked by forming a spherical cap in a hot melting or dispensing mode, and at least part of the first spiral part and the shaping part is covered on the spherical cap.

In order to achieve the above object, the present invention also provides a method for preparing an embolic material, comprising the steps of: respectively performing pre-shaping treatment on the wound first spiral part and the shaping part on a die according to a preset shape; the pre-shaped shaping component is arranged in the inner cavity of the pre-shaped first spiral component; and sleeving the wound second spiral part on the outer side of the wound first spiral part.

Optionally, the embolic material preparation method further comprises: disposing a fixation member in an inner cavity of the first helical member; the fixing parts arranged in the inner cavity of the first spiral part are respectively connected to the two ends of the first spiral part and the second spiral part in a physical winding or knotting mode; and fixing one end of the shaping part with one ends of the first and second spiral parts.

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

In summary, the embolic material and the preparation method thereof provided by the invention have the following advantages:

the first embolic material adopts a double-layer structure of a bioabsorbable material and a metal non-transmitting material, so that the embolic material can be partially degraded and absorbed within a certain time while the characteristics of good developing property, good supporting property and the like of the traditional metal spring coil are maintained, and the problems that the occupation effect of pressing surrounding tissues and nerves is possibly caused to a large-sized aneurysm and the like can be effectively relieved.

The shaping part arranged in the double-layer spiral structure of the embolic material has good visibility, and the stereoscopic pre-shaping structure can improve the stability of the embolic material, so that the embolic material can have better supportability in aneurysms.

Drawings

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

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

fig. 3 is a cross-sectional view of an embolic material in accordance with another embodiment of the invention.

Reference numerals are described as follows:

10-embolic material; 100-a first helical member; 110-lumen; 120-a second helical member; 130-shaping part; 132-distal end of the sizing component; 134-a proximal end of the sizing component; 140-distal end; 150-ball cap; 160-proximal end; 170-a fixed part.

Detailed Description

The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

As used in this specification, the singular forms "a", "an" and "the" include plural 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, as for example, they may be fixed, they may be removable, or they may be integrally connected. Either mechanically or electrically. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. The same or similar reference numbers in the drawings refer to the same or similar parts.

In addition, in the following description, for convenience of description, "distal" and "proximal" are used; "proximal" is the end that is proximal to the operator of the medical device; "distal" is the end remote from 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 invention may be practiced without one or more of these details. In other instances, well-known features have not been described in detail in order to avoid obscuring the invention.

The core idea of the invention is to provide an embolic comprising a tubular first helical member having an inner lumen, a second helical member nested on the outer side of the first helical member, and a shaping member at least partially disposed within the inner lumen of the first helical member, wherein the first helical member comprises a radio-opaque material and the second helical member comprises a bioabsorbable material, and wherein one end of the shaping member is secured to one end of the first and second helical members. The first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.

To achieve the above object, the present invention also provides an embolic comprising a tubular first helical member having an inner lumen, a second helical member wound around the outer side of the first helical member, a shaping member at least partially disposed within the inner lumen of the first helical member, and a fixation member at least partially disposed within the inner 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 the two ends of the second spiral part in a physical winding or knotting mode;

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

at least one end of the second spiral component is blocked by forming a spherical cap in a hot melting or dispensing mode, and at least part of the first spiral component and the shaping component is covered on the spherical cap.

It will be appreciated that the embolic material in the present application may be a coil for use in the treatment of intracranial vascular disease, such as intracranial aneurysms. In addition, the vascular implant can also be applied to the treatment of diseases such as non-intracranial vascular aneurysms and the like.

After the embolic material 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 the organism and converted into small molecular substances harmless to the organism, thereby playing a role in reducing the occupying effect. In addition, the setting part arranged in the double-layer spiral structure not only can improve the supportability and stability of the embolic material in the operation, but also has certain ray visibility.

The embolic material and the method of making the same according to the present invention are further described below with reference to the drawings and examples.

Fig. 1 is a partial cross-sectional view of an embolic material 10 according to an embodiment of the present invention. Fig. 2 is a cross-sectional view of the embolic material 10 shown in fig. 1. The embolic material 10 is shown in its linear primary shape, with the embolic material 10 being an elongated device of greater length extending from its proximal end 160 to its distal end 140. The proximal end of the embolic material 10 is configured to be coupled to a pusher (not shown) of the embolic material 10. The embolic material 10 comprises 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 sizing 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 setting member 130 are coaxial or axially parallel.

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

In some embodiments, the first helical member 100 is a composite member having a matrix doped with a developing substance, wherein the developing substance may be an iodine contrast agent or barium sulfate, and the matrix may be one or more of polylactic acid, polyglycolic acid, a lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid. The filiform composite member is helically wound on a stem of a predetermined diameter to form the first helical member 100.

In some embodiments, the second helical member 120 comprises a bioabsorbable material that 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 spiral member 120 may be modified, for example, by loading some active substance, which may be a growth factor or a drug molecule, into or on the surface of the second spiral member 120. The second spiral member 120 is made of a polymer or a wire material made of the above-mentioned material spirally wound on a stem of a predetermined diameter. It will be appreciated that the pitch of the coils of the second helical member 120 may be uniform or may be graded 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 formed using a bioabsorbable material ranges from 30% to 90% of the total volume of the entire embolic material 10. The embolic material 10 adopting the double-layer structure of the bioabsorbable material and the metal non-transmitting material maintains the characteristics of good developing property, good supporting property and the like of the traditional metal spring coil, and meanwhile, the bioabsorbable material part can be partially degraded and absorbed within a certain time, so that the problems of space occupying effect and the like which possibly cause compression of surrounding tissues and nerves for a large-sized aneurysm can be effectively relieved.

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

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

helical members

100, 120, and the proximal end 134 of the sizing member 130 is a free end 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 sizing 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 helical member 100, and then an atraumatic distal tip is formed at the distal ends 140 of the first helical member 100 and the second helical member 120 by heat-fusing or dispensing, and the distal end 132 of the sizing member 130 and the distal ends 140 of the first helical member 100 and the second helical member 120 are firmly bonded to each other, i.e., at least a portion of the inverted J-shaped hook and the distal ends 140 of the first helical member 100 and the second helical member 120 are wrapped around the atraumatic distal tip. The atraumatic distal tip may be a cap 150 as shown in fig. 2, or may be a conical or oval closed end. Wherein the atraumatic distal tip may be formed of a polymeric material, such as polyester, acrylic adhesive, or other polymeric material suitable for hot melt or dispensing. In other embodiments, the distal end 132 of the sizing component 130 may be connected to the distal ends 140 of the first and second

helical components

100, 120 in other ways, such as, for example, the distal end 132 of the sizing component 130 being straight, inverted J-shaped, or otherwise directly secured by the cap 150; or the distal end 132 of the shaping member 130 is first connected with at least one coil of the second helical member 120 and then wrapped and fixed by the cap 150; the setting member 130 is connected to at least one end of the first screw member 100 and the second screw member 120 either by physically winding or knotting the wires.

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. Proximal end 134 and distal end 132 may also be connected to proximal end 160 and distal end 140, respectively, of first helical member 100.

In some embodiments, the sizing component 130 comprises at least one sizing wire, wherein each sizing wire has a circular, oval, or polygonal cross-section with a diameter that does not exceed 90% of the inner diameter of the first helical component 100, wherein the inner diameter of the first helical component 100 ranges from 0.001 to 0.01 inches. The material forming the shaping member 130 is a memory alloy, and may be one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy. The sizing component 130 made of the above material not only enhances the visibility of the double-layer spiral structure in blood vessels and aneurysms, but also can be used for three-dimensionally pre-sizing the memory alloy for improving the stability of the embolic material 10 so that the embolic material can have better support in the aneurysms. 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 shape, a pentahedron shape, and a hexahedral shape.

Fig. 3 is a cross-sectional view of an embolic material 10 according to another embodiment of the present invention. The embolic material 10 comprises 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, a sizing member 130 disposed at least partially within the lumen 110 of the first helical member 100, and a fixation member 170 disposed at least partially within the lumen 110 of the first helical member 100. The structure and use of the first screw member 100, the second screw member 120, and the setting member 130 are substantially the same as those of the embodiment shown in fig. 2, and the 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 filaments are respectively connected to both ends of the first screw member 100 and the second screw member 120 by means of physical winding or knotting for fixing the first screw member 100 and the second screw member 120.

In some embodiments, the fixation element 170 is knotted to the first screw element 100 and the second screw element 120 in such a way that the fixation element 170 simultaneously knots at least one turn of the screw on the first screw element 100 and at least one turn of the screw on the second screw element 120 to keep the first screw element 100 and the second screw element 120 coaxial or axially parallel. It will be appreciated that the location of attachment of the securing member 170 to the first helical member 100 and/or the second helical member 120 is not limited to that shown in fig. 3, and that the securing member 170 may be knotted at any location along the circumference of the helical member.

As shown in FIG. 3, the fixation element 170 may be coupled to the sizing element 130 prior to tying a knot to the proximal end 140 of the first helical element 100, which serves to stabilize the fixation element 170, the first helical element 100, and the sizing element 130.

In some embodiments, the fastening member 170 may be fastened to the first screw member 100 and the second screw member 120 by: the fixing member 170 knots only at least one turn of the screw on the first screw member 100 or at least one turn of the screw on the second screw member 120.

In order to achieve the above object, the present invention further provides a method for preparing an embolic material 10, referring to fig. 3, mainly comprising the following steps:

s1, performing pre-shaping treatment on the wound first spiral part 100 and the shaping part 130 on a die according to a preset shape, wherein the preset shape can be at least one of spiral (helix), wave, tetrahedron, pentahedron and hexahedron, and the preset shapes of the first spiral part 100 and the shaping part 130 are corresponding to each other.

S2, arranging the pre-shaped shaping member 130 in the inner cavity 110 of the pre-shaped first spiral member 100, namely, penetrating the thread-shaped shaping member 130 into the inner cavity 110 of the first spiral member 100, and fixing at least one end of the shaping member 130 to at least one end of the first spiral member 100.

S3, the fixing component 170 is arranged in the inner cavity 110 of the first spiral component 100.

And S4, sleeving the wound second spiral part 120 on the outer side of the wound first spiral part 100.

S5, connecting the fixing part 170 arranged in the inner cavity 110 of the first spiral part 100 to two ends of the first spiral part 100 and the second spiral part 120 respectively in a physical winding or knotting mode, and forming the spherical cap 150 at least one end of the second spiral part 120 in a hot melting or dispensing mode for end sealing, wherein at least part of the first spiral part 100 and the shaping part 130 are coated on 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, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. An embolic comprising a tubular first helical member having a lumen, a second helical member nested on an outer side of said first helical member, and a sizing member disposed at least partially within said lumen of said first helical member, wherein said first helical member comprises a radiopaque material, said second helical member comprises a bioabsorbable material, and one end of said sizing member is secured to one end of said first and second helical members; one end of the shaping part is provided with an inverted J-shaped hook, and the inverted J-shaped hook is connected with at least one coil of the first spiral part;

the second helical member has an outer diameter in the range of 0.005-0.05 inches and a length in the range of 0.5-200 cm, wherein the cross-section of the wire around which the second helical member is wound is circular or a portion of a circle, and the wire has a diameter or radius of curvature in the size range of 2 times the diameter or radius of curvature of 0.0005-0.005 inches.

2. The embolic material of claim 1, wherein said first helical member is a metallic member made of any one of platinum, iridium, gold, silver, tantalum, and tungsten, or alloys thereof.

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

5. The embolic material of claim 1, wherein said styling member comprises at least one styling wire, wherein each of said styling wires is circular, elliptical or polygonal in cross-section.

6. The embolic material of claim 1, wherein the material of said shaping member is one or more of cobalt chrome alloy, nickel titanium alloy, and platinum tungsten alloy.

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

8. The embolic material of claim 1, wherein said first helical member has an outer diameter in the range of 0.002-0.02 inches and a length of 10% -100% of the length of the tubular structure about which said second helical member is wound, wherein the wire about which said first helical member is wound has a cross-section that is circular or a portion of a circle, and wherein the wire has a diameter or radius of curvature in the size range of 2 times that of 0.0003-0.003 inches.

9. The embolic material of claim 7, wherein said sizing member comprises at least one sizing wire having a diameter that does not exceed 90% of the inner diameter of said first helical member.

10. The embolic material of claim 1, wherein said first helical member, said second helical member, and said styling member are coaxial or axially parallel, and/or wherein the axial length of said first helical member is no greater than the axial length of said second helical member.

11. The embolic material of claim 1, wherein at least one end of said second helical member is capped by forming a cap by heat staking or dispensing, wherein at least a portion of said first helical member is wrapped around said cap.

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

13. The embolic material of claim 11, wherein at least a portion of said inverted J-hook is wrapped around said cap.

14. The embolic material of claim 1, further comprising a fixation member disposed at least partially within the lumen of said first helical member, wherein said fixation member and said first helical member are coaxial or axially parallel.

15. The embolic material of claim 14, wherein said anchor member is a polymeric wire, wherein said polymeric wire is made from one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone.

16. The embolic material of claim 15, wherein said polymer filaments are attached to both ends of said first helical member and said second helical member, respectively, by physical wrapping or knotting, for securing said first helical member and said second helical member.

17. The embolic material of claim 16, wherein said polymer wire is knotted by wrapping together at least one turn of said first spiral member and at least one turn of said second spiral member to maintain said first spiral member and said second spiral member coaxial or axially parallel.

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

19. A method of preparing an embolic material according to any one of claims 1 to 18, comprising the steps of:

respectively performing pre-shaping treatment on the wound first spiral part and the shaping part on a die according to a preset shape;

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

and sleeving the wound second spiral part on the outer side of the wound first spiral part.

20. The method of manufacturing as set forth in claim 19, further comprising:

disposing a fixation member in an inner cavity of the first helical member;

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

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

21. The method of claim 20, wherein the securing member is a polymeric wire that is knotted with the first helical member and the second helical member in a manner that the polymeric wire 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 helical member and the second helical member coaxial or axially parallel.