Embolic material and preparation method thereof

Abstract

The present invention relates to an embolic material and a preparation method thereof, comprising a tubular first spiral component with an inner cavity, a second spiral component nested on the outer side of the first spiral component, and a shaping component at least partially placed in the inner cavity of the first spiral component, wherein the first spiral component comprises a radiopaque material, the second spiral component comprises a bioabsorbable material, and one end of the shaping component is fixed to one end of the first and second spiral components. The shaping component is arranged in the double-layer structured embolic material, so that the embolic material not only has the performance of being degradable and alleviating the space-occupying effect, but also has the characteristics of good visualization and support in the aneurysm.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intravascular embolism and a preparation method thereof. Background Art

[0002] With the improvement of domestic living standards, the incidence of vascular diseases caused by abnormal changes or aging of blood vessels is also increasing year by year, including intracranial aneurysms, visceral aneurysms, peripheral arterial aneurysms, arteriovenous malformations and hemangiomas. For such diseases, the treatment options adopted at home and abroad are mainly surgical treatment and interventional treatment. Due to the huge trauma and a series of complications caused by surgical treatment, minimally invasive endovascular treatment is increasingly favored by doctors and patients. For example, coils are implanted in aneurysms or malformed blood vessels for embolization to change hemodynamics, achieve complete embolism or thrombosis to achieve the purpose of treatment.

[0003] At present, the coils available on the market include: pre-shaped bare metal coils, biomodified coils with bioactive materials on the surface, and highly expandable hydrogel coils. Among them, the bare metal coil Axium Prime is made of platinum tungsten alloy material and is prefabricated into a two-dimensional or three-dimensional structure for intraoperative embolization. The biomodified coil Matrix, by covering the surface of the metal coil with a layer of PLGA (polylactic-co-glycolic acid) material, uses the thrombosis-inducing and biodegradable properties of the PLGA material itself to reduce the space-occupying effect. The hydrogel coil Hydrocoil adds hydrophilic polypropylene hydrogel inside the metal coil. After implantation, the hydrogel absorbs a large amount of water and expands dramatically, completely filling the coil cavity to reduce the recanalization rate of the aneurysm.

[0004] At present, degradable / absorbable coils are still in the conceptual stage, and there are no mature products on the market. According to research, coils made of absorbable bioactive materials usually have good X-ray transmittance, so that the imaging effect is poor during the actual push operation, which increases the difficulty of doctors' surgical operations. In addition, a few reports have proposed adding radiopaque components to degradable coils. The structure of this coil structure is relatively complex, and the difficulty of connecting and fixing the components is relatively high.

[0005] Therefore, a new embolic material is needed to solve at least the above problems. Summary of the invention

[0006] The present invention provides an embolic material and a preparation method thereof. Under the premise that the visibility of the embolic material meets clinical needs and the support and stability of the embolic material in the aneurysm are sufficient, at least a portion of the embolic material can be gradually degraded and absorbed by the body and converted into small molecules that are harmless to the body, thereby alleviating the space-occupying effect.

[0007] To achieve the above-mentioned purpose, the present invention provides an embolic material, comprising a tubular first spiral component with an inner cavity, a second spiral component nested in the outer side of the first spiral component, and a shaping component at least partially placed in the inner cavity of the first spiral component, wherein the first spiral component comprises a radiopaque material, the second spiral component comprises a bioabsorbable material, and one end of the shaping component is fixed to one end of the first and second spiral components.

[0008] Optionally, the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.

[0009] Optionally, the first spiral component is a metal component made of one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof.

[0010] Optionally, the first spiral component is a composite material component in which a developing substance is doped 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.

[0011] 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, magnesium alloy, iron and iron alloy.

[0012] Optionally, the shaping component comprises at least one shaping wire, wherein the cross-section of each shaping wire is circular, elliptical or polygonal.

[0013] Optionally, the material of the shaping component is one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

[0014] Optionally, the shaping component has at least one secondary structure of a spiral, a wave, a tetrahedron, a pentahedron and a hexahedron.

[0015] Optionally, the outer diameter of the second spiral component ranges from 0.005 to 0.05 inches, and the length ranges from 0.5 to 200 centimeters, wherein the cross-section of the wire wound around the second spiral component is circular or a portion of a circle, and the diameter of the wire or twice the radius of curvature ranges from 0.0005 to 0.005 inches.

[0016] Optionally, the outer diameter of the first spiral component ranges from 0.002 to 0.02 inches, and the length is 10% to 100% of the length of the tubular structure formed by winding the second spiral component, wherein the cross-section of the wire used to wind the first spiral component is circular or a part of a circle, and the diameter of the wire or twice the radius of curvature ranges from 0.0003 to 0.003 inches.

[0017] Optionally, the shaping component comprises at least one shaping wire, and the diameter of the shaping wire does not exceed 90% of the inner diameter of the first spiral component.

[0018] Optionally, the first spiral component, the second spiral component and the shaping component are coaxial or axially parallel, and / or the axial length of the first spiral component is not greater than the axial length of the second spiral component.

[0019] Optionally, at least one end of the second spiral component is sealed by forming a spherical cap by hot melting or dispensing, wherein at least a portion of the first spiral component is covered by the spherical cap.

[0020] Optionally, one end of the shaping component is fixed to one end of the first and second spiral components through the ball cap.

[0021] Optionally, one end of the shaping component is configured as an inverted J-shaped hook, and at least a portion of the inverted J-shaped hook is covered by the ball cap.

[0022] Optionally, the embolic material further comprises a fixing component at least partially disposed in an inner cavity of the first spiral component, wherein the fixing component and the first spiral component are coaxial or axially parallel.

[0023] Optionally, the fixing component is a polymer filament, wherein the material making the polymer filament is one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone.

[0024] Optionally, the polymer filaments are respectively connected to both ends of the first spiral component and the second spiral component by physically winding or knotting, so as to fix the first spiral component and the second spiral component.

[0025] Optionally, the polymer filament is knotted by winding at least one spiral turn on the first spiral component and at least one spiral turn on the second spiral component together to keep the first spiral component and the second spiral component coaxial or axially parallel.

[0026] Optionally, the embolic material has at least one secondary structure of a spiral, a wavy, a tetrahedron, a pentahedron and a hexahedron.

[0027] To achieve the above-mentioned purpose, the present invention also provides an embolic material, comprising a tubular first spiral component with an inner cavity, a second spiral component wound around the outer side of the first spiral component, a shaping component at least partially placed in the inner cavity of the first spiral component, and a fixing component at least partially placed in the inner cavity of the first spiral component, wherein: the first spiral component comprises a radiopaque material, and the second spiral component comprises a bioabsorbable material; the fixing component is respectively connected to both ends of the second spiral component by physical winding or knotting; one end of the shaping component is fixed to one end of the first and second spiral components; and at least one end of the second spiral component is sealed by forming a spherical cap by hot melting or dispensing, and at least part of the first spiral component and the shaping component are covered by the spherical cap.

[0028] To achieve the above-mentioned purpose, the present invention also provides a method for preparing an embolic material, which is characterized in that it includes the following steps: pre-forming a wound first spiral component and a shaping component on a mold according to preset shapes; arranging the pre-shaped shaping component in the inner cavity of the pre-shaped first spiral component; and sleeve-arranging the wound second spiral component on the outside of the wound first spiral component.

[0029] Optionally, the embolic preparation method further includes: setting a fixing component in the inner cavity of the first spiral component; connecting the fixing component set in the inner cavity of the first spiral component to the two ends of the first spiral component and the second spiral component respectively by physical winding or knotting; and fixing one end of the shaping component to one end of the first and second spiral components.

[0030] Optionally, the polymer filament is knotted with the first spiral component and the second spiral component in such a manner that the polymer filament simultaneously knots at least one spiral turn on the first spiral component and at least one spiral turn on the second spiral component to keep the first spiral component and the second spiral component coaxial or axially parallel.

[0031] In summary, the embolic material and the preparation method thereof provided by the present invention have the following advantages:

[0032] First, the above-mentioned embolic material adopts a double-layer structure of bioabsorbable material and metal opaque material, so that the embolic material can maintain the good visualization and support characteristics of traditional metal spring coils while the bioabsorbable material part can be partially degraded and absorbed within a certain period of time, which can effectively alleviate the problems of space-occupying effect that may cause compression of surrounding tissues and nerves in large aneurysms.

[0033] Second, the shaping component provided in the double-layer spiral structure of the embolic material not only has good visibility, but also has a three-dimensional pre-shaped structure that can improve the stability of the embolic material, so that it can have better support in the aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a partial cross-sectional view of an embolic material according to an embodiment of the present invention;

[0035] Figure 2 yes Figure 1 A cross-sectional view of the embolus is shown;

[0036] Figure 3 is a cross-sectional view of an embolic object according to another embodiment of the present invention.

[0037] [Description of reference numerals is as follows]:

[0038] 10-embolism; 100-first spiral component; 110-inner cavity; 120-second spiral component; 130-shaped component; 132-distal end of the shaped component; 134-proximal end of the shaped component; 140-distal end; 150-ball cap; 160-proximal end; 170-fixing component. DETAILED DESCRIPTION

[0039] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0040] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The same or similar figure marks in the drawings represent the same or similar parts.

[0041] In addition, in the following description, for ease of description, "distal end" and "proximal end" are used; "proximal end" is the end close to the operator of the medical device; "distal end" is the end away from the operator of the medical device. In addition, in the following description, a large number of specific details are given to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.

[0042] The core idea of ​​the present invention is to provide an embolic material, comprising a tubular first spiral component with an inner cavity, a second spiral component nested on the outer side of the first spiral component, and a shaping component at least partially placed in the inner cavity of the first spiral component, wherein the first spiral component comprises a radiopaque material, the second spiral component comprises a bioabsorbable material, and one end of the shaping component is fixed to one end of the first and second spiral components. The first spiral component comprises a radiopaque material, and the second spiral component comprises a bioabsorbable material.

[0043] To achieve the above object, the present invention further provides an embolic material, comprising a tubular first spiral component having an inner cavity, a second spiral component wound around the outer side of the first spiral component, a shaping component at least partially disposed in the inner cavity of the first spiral component, and a fixing component at least partially disposed in the inner cavity of the first spiral component, wherein:

[0044] The first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material;

[0045] The fixing member is respectively connected to two ends of the second spiral member by physically winding or tying a knot;

[0046] One end of the shaping component is fixed to one end of the first and second spiral components; and

[0047] At least one end of the second spiral component is sealed by forming a spherical cap by hot melting or dispensing, and at least a part of the first spiral component and the shaping component are covered by the spherical cap.

[0048] It is understandable that the embolic material in the present application can be a coil used for treating intracranial vascular diseases, such as intracranial aneurysms and other vascular diseases. In addition, the vascular implant can also be used for treating non-intracranial vascular aneurysms and other diseases.

[0049] After the embolism is implanted in the lesion for a period of time, the biological material in the double-layer structure can be gradually degraded and absorbed by the body, and converted into small molecules that are harmless to the body, thereby reducing the space-occupying effect. In addition, the shaping components set in the double-layer spiral structure can not only improve the support and stability of the embolism during surgical operations, but also have a certain degree of radiographic visibility.

[0050] The embolic material and the preparation method thereof provided by the present invention are further described below in conjunction with the accompanying drawings and several embodiments.

[0051] Figure 1 FIG. 1 is a partial cross-sectional view of an embolic material 10 according to an embodiment of the present invention. Figure 2 yes Figure 1 The cross-sectional view of the embolic object 10 shown in the figure. As shown in the figure, the embolic object 10 is in its linear primary shape, and the embolic object 10 is a long slender device extending from its proximal end 160 to its distal end 140. The proximal end of the embolic object 10 is arranged to be connected with a pushing device (not shown) of the embolic object 10. The embolic object 10 includes a tubular first spiral component 100 with an inner cavity 110, a second spiral component 120 nested on the outer side of the first spiral component 100, and a shaping component 130 at least partially placed in the inner cavity 110 of the first spiral component 100. Wherein, the first spiral component 100, the second spiral component 120 and the shaping component 130 are coaxial or axially parallel.

[0052] The first helical component 100 includes a radiopaque material. In some embodiments, the first helical component 100 is a metal component 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 preset diameter to form the first helical component 100. The pitch of the coil of the first helical component 100 may be uniform, or may gradually change along the length of the coil, or may have different pitches in different sections of the coil.

[0053] In some embodiments, the first spiral component 100 is a composite material component doped with a developing material in a matrix, wherein the developing material may be an 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 filamentous composite material component is spirally wound on a core column of a preset diameter to form the first spiral component 100.

[0054] In some embodiments, the second spiral component 120 includes 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, magnesium alloy, iron and iron alloy. In some embodiments, the second spiral component 120 may also be modified, for example, some active substances may be loaded inside or on the surface of the second spiral component 120, which may be growth factors or certain drug molecules. The polymer or metal wire made of the above materials is spirally wound on a core column of a preset diameter to form the second spiral component 120. It is understandable that the pitch of the coil of the second spiral component 120 may be uniform, may gradually change along the length of the coil, and may have different pitches in different sections of the coil.

[0055] The volume of the second spiral component 120 made of bioabsorbable material accounts for 30%-90% of the total volume of the entire embolic material 10. The embolic material 10 with a double-layer structure of bioabsorbable material and metal radiopaque material maintains the good visualization and support characteristics of traditional metal spring coils, while the bioabsorbable material part can be partially degraded and absorbed within a certain period of time, which can effectively alleviate the problems of space-occupying effect that may cause compression of surrounding tissues and nerves for large aneurysms.

[0056] In some embodiments, the outer diameter of the first spiral component 100 ranges from 0.002 to 0.02 inches, the cross-section of the wire wound around the first spiral component 100 is circular or a part of a circle, and the diameter or twice the radius of curvature of the wire ranges from 0.0003 to 0.003 inches. The outer diameter of the second spiral component 120 ranges from 0.005 to 0.05 inches, the cross-section of the wire wound around the second spiral component 120 is circular or a part of a circle, and the diameter or twice the radius of curvature of the wire ranges from 0.0005 to 0.005 inches. Continue to refer to Figure 1 and Figure 2 The second spiral component 120 is coated on the outside of the first spiral component 100, and the axial length of the first spiral component 100 is not greater than the axial length of the second spiral component 120. The length of the second spiral component 120 ranges from 0.5 to 200 cm, and the length of the first spiral component 100 is slightly shorter than that of the second spiral component 120, which is 10% to 100% of the length of the tubular structure formed by winding the second spiral component 120.

[0057] like Figure 2As shown, the distal end 132 of the shaping component 130 is fixed to the distal ends 140 of the first spiral component 100 and the second spiral component 120, and the proximal end 134 of the shaping component 130 is a free end, which is disposed in the proximal inner cavity 110 of the first spiral component 100. In one embodiment of the present application, the distal end 132 of the shaping component 130 is configured as an inverted J-shaped hook, which is connected to at least one coil of the distal end 140 of the first spiral component 100, such as the last coil, and then a non-traumatic distal tip is formed at the distal ends 140 of the first spiral component 100 and the second spiral component 120 by hot melting or dispensing, and the distal end 132 of the shaping component 130 and the distal ends 140 of the first spiral component 100 and the second spiral component 120 are firmly combined with each other, that is, at least a portion of the inverted J-shaped hook and the distal ends 140 of the first spiral component 100 and the second spiral component 120 are coated on the non-traumatic distal tip. The non-traumatic distal tip can be Figure 2 The ball cap 150 shown may also be a conical or elliptical closed end. Wherein, the atraumatic distal tip may be formed of a polymer material, such as polyester, acrylic adhesive or other polymer materials suitable for hot melt or dispensing. In some other embodiments, the distal end 132 of the shaping component 130 may also be connected to the distal end 140 of the first spiral component 100 and the second spiral component 120 in other ways, for example, the distal end 132 of the shaping component 130 of a straight, inverted J-shaped or other shape is directly wrapped and fixed by the ball cap 150; or the distal end 132 of the shaping component 130 is first connected to at least one coil of the second spiral component 120 and then wrapped and fixed by the ball cap 150; or the shaping component 130 is connected to at least one end of the first spiral component 100 and the second spiral component 120 by physically winding or tying a silk thread.

[0058] In some embodiments, the proximal end 134 of the shaping member 130 is connected to the proximal end 160 of the first spiral member 100, and the distal end 132 is a free end. Alternatively, the proximal end 134 and the distal end 132 may be connected to the proximal end 160 and the distal end 140 of the first spiral member 100, respectively.

[0059] In some embodiments, the shaping component 130 includes at least one shaping wire, wherein the cross-section of each shaping wire is circular, elliptical or polygonal, and its diameter does not exceed 90% of the inner diameter of the first spiral component 100, wherein the inner diameter of the first spiral component 100 ranges from 0.001 to 0.01 inches. The material forming the shaping component 130 is a memory alloy, which can be one or more of a cobalt-chromium alloy, a nickel-titanium alloy and a platinum-tungsten alloy. The shaping component 130 made of the above materials not only enhances the visibility of the double-layer spiral structure in blood vessels and aneurysms, but also can perform three-dimensional pre-shaping on the memory alloy to improve the stability of the embolism 10, so that it can have better support in the aneurysm. In some embodiments, the shaping component 130 can be pre-shaped to have at least one secondary structure of a spiral, a wavy shape, a tetrahedron, a pentahedron and a hexahedron.

[0060] Figure 3 1 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 spiral component 100 having an inner cavity 110, a second spiral component 120 nested on the outer side of the first spiral component 100, a shaping component 130 at least partially disposed in the inner cavity 110 of the first spiral component 100, and a fixing component 170 at least partially disposed in the inner cavity 110 of the first spiral component 100. The structures and usage of the first spiral component 100, the second spiral component 120 and the shaping component 130 are as follows: Figure 2 The embodiments shown are substantially the same and will not be described again. In some embodiments, the fixing member 170 and the first spiral member 100 are coaxial or axially parallel.

[0061] like Figure 3 As shown, the fixing member 170 may be a polymer filament, and the material of the polymer filament is one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone. The polymer filament is connected to both ends of the first spiral member 100 and the second spiral member 120 by physical winding or knotting, so as to fix the first spiral member 100 and the second spiral member 120.

[0062] In some embodiments, the fixing member 170 and the first spiral member 100 and the second spiral member 120 are tied in a manner that the fixing member 170 simultaneously ties at least one spiral turn on the first spiral member 100 and at least one spiral turn on the second spiral member 120 to keep the first spiral member 100 and the second spiral member 120 coaxial or axially parallel. It is understood that the connection position of the fixing member 170 and the first spiral member 100 and / or the second spiral member 120 is not limited to Figure 3 As shown, the fixing member 170 can be tied at any position on the circumference of the spiral member.

[0063] like Figure 3 As shown, before the fixing member 170 is tied with the proximal end 140 of the first spiral member 100 , it can be connected with the shaping member 130 first, so as to stabilize the fixing member 170 , the first spiral member 100 and the shaping member 130 .

[0064] In some embodiments, the fixing member 170 may be tied with the first spiral member 100 and the second spiral member 120 in such a manner that the fixing member 170 only ties a knot to at least one spiral circle on the first spiral member 100 or at least one spiral circle on the second spiral member 120 .

[0065] To achieve the above object, the present invention also provides a method for preparing an embolic material 10, referring to Figure 3 , mainly including the following steps:

[0066] S1, pre-forming the wound first spiral component 100 and the shaping component 130 on the mold according to preset shapes, wherein the preset shape can be at least one of a spiral (Helical), a wave shape, a tetrahedron, a pentahedron and a hexahedron, and the preset shapes of the first spiral component 100 and the shaping component 130 also correspond to each other.

[0067] S2, setting the pre-shaped shaping component 130 in the inner cavity 110 of the pre-shaped first spiral component 100, that is, passing the filamentary shaping component 130 into the inner cavity 110 of the first spiral component 100, and fixing at least one end of the shaping component 130 to at least one end of the first spiral component 100.

[0068] S3 , disposing the fixing member 170 in the inner cavity 110 of the first spiral member 100 .

[0069] S4, sleeve the wound second spiral component 120 on the outer side of the wound first spiral component 100.

[0070] S5, the fixing component 170 disposed in the inner cavity 110 of the first spiral component 100 is respectively connected to the two ends of the first spiral component 100 and the second spiral component 120 by physical winding or knotting, and a ball cap 150 is formed at at least one end of the second spiral component 120 by hot melting or dispensing to seal it, wherein at least part of the first spiral component 100 and the shaping component 130 are covered by the ball cap 150.

[0071] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these 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 these modifications and variations.

Claims

1. An embolic material, comprising a tubular first spiral component having an inner cavity, a second spiral component nested on the outer side of the first spiral component, and a shaping component at least partially disposed in the inner cavity of the first spiral component, characterized in that: The first helical component comprises a radiopaque material, the second helical component comprises a bioabsorbable material, and one end of the shaping component is fixed to one end of the first and second helical components; The embolic material also includes a fixing component at least partially placed in the inner cavity of the first spiral component, wherein the fixing component and the first spiral component are coaxial or axially parallel; the fixing component is a polymer filament, and the polymer filament is respectively connected to the two ends of the first spiral component and the second spiral component by physical winding or knotting, so as to fix the first spiral component and the second spiral component.

2. The embolic material according to claim 1, characterized in that: The first spiral component is a metal component made of any one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof.

3. The embolic material according to claim 1, characterized in that: The first spiral component is a composite material component in which a developing substance is doped in a matrix, wherein the developing substance is an iodine contrast agent or barium sulfate, and the 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 according to claim 1, characterized in that: The second spiral component is any one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium, magnesium alloy, iron and iron alloy.

5. The embolic material according to claim 1, characterized in that: The shaping component comprises at least one shaping wire, wherein the cross section of each shaping wire is circular, elliptical or polygonal.

6. The embolic material according to claim 1, characterized in that: The material of the shaping component is one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

7. The embolic material according to claim 1, characterized in that: The shaping component has at least one secondary structure of a spiral, a wave, a tetrahedron, a pentahedron and a hexahedron.

8. The embolic material according to claim 1, characterized in that: The outer diameter of the second spiral component ranges from 0.005 to 0.05 inches, and the length ranges from 0.5 to 200 centimeters, wherein the cross-section of the wire wound around the second spiral component is circular or a part of a circle, and the diameter of the wire or twice the radius of curvature ranges from 0.0005 to 0.005 inches.

9. The embolic material according to claim 8, characterized in that: The outer diameter of the first spiral component ranges from 0.002 to 0.02 inches, and the length is 10% to 100% of the length of the tubular structure formed by winding the second spiral component, wherein the cross-section of the wire used to wind the first spiral component is circular or a part of a circle, and the diameter of the wire or twice the radius of curvature ranges from 0.0003 to 0.003 inches.

10. The embolic material according to claim 8, characterized in that: The shaping component includes at least one shaping wire, and the diameter of the shaping wire does not exceed 90% of the inner diameter of the first spiral component.

11. The embolic material according to claim 1, characterized in that: The first spiral component, the second spiral component and the shaping component are coaxial or axially parallel, and / or the axial length of the first spiral component is not greater than the axial length of the second spiral component.

12. The embolic material according to claim 1, characterized in that: At least one end of the second spiral component is sealed by forming a spherical cap by hot melting or dispensing, wherein at least a portion of the first spiral component is covered by the spherical cap.

13. The embolic material according to claim 12, characterized in that: One end of the shaping component is fixed to one end of the first and second spiral components through the ball cap.

14. The embolic material according to claim 12, characterized in that: One end of the shaping component is configured as an inverted J-shaped hook, and at least a portion of the inverted J-shaped hook is covered by the ball cap.

15. The embolic material according to claim 1, characterized in that: The polymer filaments are made of one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone.

16. The embolic material according to claim 15, characterized in that: The polymer filament is knotted by winding at least one spiral turn on the first spiral component and at least one spiral turn on the second spiral component together to keep the first spiral component and the second spiral component coaxial or axially parallel.

17. The embolic material according to claim 1, characterized in that: The embolic material has at least one secondary structure of a spiral, a wave, a tetrahedron, a pentahedron and a hexahedron.

18. An embolic material, comprising a tubular first spiral component having an inner cavity, a second spiral component wound around the outer side of the first spiral component, a shaping component at least partially disposed in the inner cavity of the first spiral component, and a fixing component at least partially disposed in the inner cavity of the first spiral component, characterized in that: The first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material; The fixing member is respectively connected to two ends of the second spiral member by physically winding or tying a knot; One end of the shaping component is fixed to one end of the first and second spiral components; and At least one end of the second spiral component is sealed by forming a spherical cap by hot melting or dispensing, and at least a part of the first spiral component and the shaping component are covered by the spherical cap.

19. A method for preparing an embolic material according to any one of claims 1 to 18, characterized in that: The following steps are involved: The wound first spiral component and the shaping component are respectively subjected to a pre-shaping process on a mold according to a preset shape; The predetermined shaping component is arranged in the inner cavity of the predetermined first spiral component; as well as The wound second spiral component is sleeved on the outer side of the wound first spiral component.

20. The preparation method according to claim 19, characterized in that: Also includes: Disposing a fixing component in the inner cavity of the first spiral component; Connecting the fixing member disposed in the inner cavity of the first spiral member to both ends of the first spiral member and the second spiral member respectively by physically winding or tying a knot; and One end of the shaping component is fixed together with one end of the first and second spiral components.

21. The preparation method according to claim 20, characterized in that: The polymer filament is knotted with the first spiral component and the second spiral component in such a manner that the polymer filament simultaneously knots at least one spiral turn on the first spiral component and at least one spiral turn on the second spiral component to keep the first spiral component and the second spiral component coaxial or axially parallel.

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