An embolus and a method of making the same

Abstract

The present application relates to a kind of embolus and its preparation method, including the tubular first spiral component with inner cavity, the second spiral component nested in the outer side of the first spiral component and at least part is placed in the inner cavity of the first spiral component Fixed component, wherein the first spiral component includes radiopaque material, the second spiral component includes bioabsorbable material, the both ends of the fixed component are connected to the both ends of the second spiral component respectively, to fix the first spiral component and the second spiral component.The double-layer structure of the embolus is provided with fixed component, so that the embolus not only has the performance of degradable and alleviates the effect of occupying position, but also makes it have better structural stability in aneurysm.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an intravascular embolic agent and its preparation method. Background Technology

[0002] Intracranial aneurysms are abnormal protrusions in the walls of intracranial arteries, forming aneurysmal lesions. Studies have found that the incidence of intracranial aneurysms has been increasing in recent years, and the disease has a high mortality and disability rate. Therefore, improving the cure rate of intracranial aneurysms has become an urgent problem to be solved.

[0003] With advancements in imaging and materials science, coil embolization of intracranial aneurysms, compared to surgical procedures, has gained increasing attention and importance due to its advantages such as minimal invasiveness, low risk, and fewer complications. Currently, most coils used in interventional therapy are made of metal. After being inserted into the aneurysm cavity, they can effectively alter blood flow direction and reduce pressure on the aneurysm wall; simultaneously, they can induce thrombus formation and promote endothelialization at the aneurysm neck, thus achieving the treatment of intracranial aneurysms.

[0004] However, traditional metal coil embolization of aneurysms still has certain limitations for large or giant aneurysms: the coils remain permanently within the aneurysm cavity, potentially causing a mass effect and compressing surrounding nerves and tissues. Using bioabsorbable materials to fabricate coils and implanting them into the aneurysm allows the aneurysm to gradually shrink in size as the coils degrade and are absorbed, thus reducing the mass effect. Furthermore, the bioactive materials can accelerate fibroblast regeneration at the aneurysm neck, promoting vascular smooth muscle regeneration, which has attracted widespread attention.

[0005] Currently, coils containing biodegradable / absorbable materials are still in the conceptual stage, and there are no mature commercial products yet. According to research, coils made of absorbable bioactive materials typically have high X-ray permeability, resulting in poor imaging during actual insertion and increasing the difficulty of surgical procedures. Additionally, a few reports have proposed adding radiopaque components to biodegradable coils; however, this type of coil structure is relatively complex, and the connection and fixation between components are also relatively difficult.

[0006] Therefore, a new embolic material is needed to solve at least the problems mentioned above. Summary of the Invention

[0007] This invention provides an embolic material and its preparation method. Under the premise that the visibility meets clinical needs and its support and stability in aneurysms are met, at least part of the embolic material can be gradually degraded and absorbed by the body and transformed into small molecule substances that are harmless to the body, thereby reducing the space-occupying effect.

[0008] To achieve the above objectives, the present invention provides an embolic device comprising a tubular first helical component having an inner cavity, a second helical component nested on the outer side of the first helical component, and a fixing component at least partially disposed within the inner cavity of the first helical component. The first helical component comprises a radiopaque material, the second helical component comprises a bioabsorbable material, and the two ends of the fixing component are respectively connected to the two ends of the second helical component to fix the first helical component and the second helical component.

[0009] Optionally, the first helical component comprises a radiopaque material, and the second helical component comprises a bioabsorbable material.

[0010] Optionally, the first spiral component is a metal component made of one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof.

[0011] Optionally, the first spiral component is a composite material component in which a developing substance is doped into the 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.

[0012] Optionally, the second helical component is one or more of polylactic acid, polyhydroxyacetic acid, lactic acid-hydroxyacetic acid copolymer, polydioxane, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium, magnesium alloy, iron and iron alloy.

[0013] Optionally, the fixing component is a polymer filament, wherein the polymer filament is one or more of polypropylene, nylon, polyester, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone.

[0014] Optionally, the polymer filaments are connected to both ends of the second spiral component by physical winding or knotting to fix the first spiral component and the second spiral component.

[0015] Optionally, the two ends of the polymer filament are connected to the two ends of the first spiral component and the second spiral component respectively by knotting.

[0016] Optionally, the polymer filaments are knotted to at least one turn of the spiral on the first spiral component of the inner ring and at least one turn of the spiral on the second spiral component of the outer ring, respectively.

[0017] Optionally, the polymer filaments are knotted together to wind at least one turn of the spiral on the first spiral component and at least one turn of the spiral on the second spiral component together to keep the first spiral component and the second spiral component coaxial or axially parallel.

[0018] Optionally, the first helical component includes a first helical unit and a second helical unit, wherein the first helical unit and the second helical unit are coaxial or axially parallel.

[0019] Optionally, the fixing component is a polymer filament, which passes through the inner cavities of the first spiral unit and the second spiral unit respectively. The portion of the polymer filament that passes through the first spiral unit and the second spiral unit is connected to the second spiral component to fix the first spiral unit, the second spiral unit, and the second spiral component.

[0020] Optionally, the fixing component is a curing adhesive, which is disposed between the first spiral component and the second spiral component, and at least partially placed in the inner cavity of the first spiral component, for fixing the first spiral component and the second spiral component.

[0021] Optionally, the fixing component includes a first curing adhesive and a second curing adhesive, which are respectively disposed at the two ends of the second spiral component.

[0022] Optionally, the fixing component further includes a third curing adhesive, which is disposed at any position between the first curing adhesive and the second curing adhesive.

[0023] Optionally, the first helical component and the second helical component are coaxial or axially parallel, and / or the axial length of the first helical component is not greater than the axial length of the second helical component.

[0024] Optionally, at least one end of the second spiral component is sealed by forming a spherical cap through hot melting or dispensing, wherein the end of the first spiral component is also covered by the spherical cap.

[0025] Optionally, at least a portion of the fixing component near the end of the second spiral component is also covered by the ball cap.

[0026] Optionally, the plug may further include a shaping component that is at least partially disposed within the cavity of the first spiral component, one end of which is covered by the ball cap.

[0027] Optionally, the shaping component includes at least one shaping filament, wherein the cross-section of each shaping filament is circular, elliptical, or polygonal.

[0028] Optionally, the material of the shaping component is one or more of cobalt-chromium alloy, nickel-titanium alloy, and platinum-tungsten alloy.

[0029] Optionally, the shaping component has at least one secondary shaping structure selected from spiral, wavy, tetrahedral, pentahedral, and hexahedral shapes.

[0030] Optionally, the outer diameter of the tubular second helical component ranges from 0.005 to 0.05 inches, and the length ranges from 0.5 to 200 centimeters. The cross-section of the filament wound around the second helical component is circular or a portion of a circle, and the diameter or radius of curvature of the filament is twice the size of the filament, ranging from 0.0005 to 0.005 inches.

[0031] Optionally, the outer diameter of the tubular first helical component ranges from 0.002 to 0.02 inches, and the length is 10% to 100% of the length of the tubular second helical component, wherein the cross-section of the filament wound around the first helical component is circular or a portion of a circle, and the diameter or radius of curvature of the filament ranges from 0.0003 to 0.003 inches, which is twice the size of the filament's diameter or radius of curvature.

[0032] To achieve the above objectives, the present invention also provides an embolic device, comprising a tubular first helical component having an inner cavity, a second helical component wound around the outer side of the first helical component, a shaping component at least partially disposed within the inner cavity of the first helical component, and a fixing component at least partially disposed within the inner cavity of the first helical component, wherein: the first helical component comprises a radiopaque material, and the second helical component comprises a bioabsorbable material; the fixing component is connected to both ends of the second helical component by physical winding or knotting; one end of the shaping component is fixed to one end of the first and second helical components; and at least one end of the second helical component is sealed by forming a ball cap by hot melting or adhesive application, wherein at least a portion of the first helical component and the shaping component covers the ball cap.

[0033] To achieve the above objectives, the present invention also provides a method for preparing an embolic material, characterized by comprising the following steps: pre-forming a wound first helical component in a mold according to a preset shape; placing a fixing component in the inner cavity of the first helical component; and sleeve a wound second helical component on the outside of the wound first helical component.

[0034] Optionally, the preparation method further includes: pre-shaping the wound shaping component on a mold according to a preset shape; setting the pre-shaped shaping component in the inner cavity of the pre-shaped first spiral component; connecting the fixing component in the inner cavity of the first spiral component to both 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.

[0035] Optionally, the polymer filament is knotted with the first spiral component and the second spiral component by first knotting the polymer filament with at least one spiral turn on the inner ring of the first spiral component, and then knotting it with at least one spiral turn on the outer ring of the second spiral component.

[0036] Optionally, the polymer filament is knotted with the first spiral component and the second spiral component by simultaneously knotting at least one spiral turn on the first spiral component and at least one spiral turn on the second spiral component, so as to keep the first spiral component and the second spiral component coaxial or axially parallel.

[0037] In summary, the embolic material and its preparation method provided by the present invention have the following advantages:

[0038] First, the aforementioned embolic material adopts a double-layer structure of bioabsorbable material and non-transmissive metal material. This allows the embolic material to maintain the good imaging and support characteristics of traditional metal coils, while the bioabsorbable material portion can be partially degraded and absorbed within a certain period of time. This can effectively alleviate problems such as the space-occupying effect that may cause compression of surrounding tissues and nerves in large aneurysms.

[0039] Secondly, the double-layer spiral structure of the aforementioned embolic material has a reasonable connection and fixation between different components, maintaining the basic coaxiality or axial parallelism of the double-layer structure, which effectively improves the operability for doctors in using the embolic material. Attached Figure Description

[0040] Figure 1 This is a partial cross-sectional view of the embolic device according to the first embodiment of the present invention;

[0041] Figure 2 yes Figure 1 A cross-sectional view of the embolism shown;

[0042] Figure 3 This is a cross-sectional view of the embolus according to the second embodiment of the present invention;

[0043] Figure 4 This is a cross-sectional view of the embolus according to the third embodiment of the present invention;

[0044] Figure 5 This is a cross-sectional view of the embolus according to the fourth embodiment of the present invention;

[0045] Figure 6 This is a cross-sectional view of the embolization device according to the fifth embodiment of the present invention.

[0046] [The annotations in the attached figures are explained below]:

[0047] 10-Implant; 100-First helical component; 102-First helical unit; 104-Second helical unit; 106-Third helical unit; 110-Inner cavity; 120-Second helical component; 130-Shaping component; 132-Distal end of shaping component; 134-Proximal end of shaping component; 140-Distal end; 150-Spherical cap; 160-Proximal end; 170-Fixing component; 171, 173, 175-Parts of polymer filaments passing through the first and second helical units; 172-First curing adhesive; 174-Second curing adhesive; 176-Third curing adhesive; 177-Distal end of fixing component; 179-Proximal end of fixing component. Detailed Implementation

[0048] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention.

[0049] As used herein, the singular forms “a,” “an,” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or,” unless otherwise expressly indicated, and the terms “installed,” “connected,” and “linked” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can represent internal communication between two elements or an interaction between two elements. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. The same or similar reference numerals in the drawings represent the same or similar parts.

[0050] Furthermore, in the following description, for ease of description, the terms "distal" and "proximal" are used; "proximal" is the end closer to the medical device operator; "distal" is the end farther from the medical device operator. Additionally, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with the invention.

[0051] The core idea of ​​this invention is to provide an embolic device, comprising a tubular first helical component with an inner cavity, a second helical component nested on the outer side of the first helical component, and a fixing component at least partially disposed within the inner cavity of the first helical component. The first helical component comprises a radiopaque material, the second helical component comprises a bioabsorbable material, and the two ends of the fixing component are respectively connected to the two ends of the second helical component to fix the first helical component and the second helical component.

[0052] To achieve the above objectives, the present invention also provides an embolic device, comprising a tubular first helical component having an inner cavity, a second helical component wound around the outer side of the first helical component, a shaping component at least partially disposed within the inner cavity of the first helical component, and a fixing component at least partially disposed within the inner cavity of the first helical component, wherein: the first helical component comprises a radiopaque material, and the second helical component comprises a bioabsorbable material; the fixing component is connected to both ends of the second helical component by physical winding or knotting; one end of the shaping component is fixed to one end of the first and second helical components; and at least one end of the second helical component is sealed by forming a ball cap by hot melting or adhesive application, wherein at least a portion of the first helical component and the shaping component covers the ball cap.

[0053] It is understood that the embolic device in this application could be a coil used to treat intracranial vascular diseases, such as intracranial aneurysms. Additionally, this vascular implant could also be used to treat non-intracranial vascular diseases such as aneurysms.

[0054] After being implanted into the lesion for a period of time, the biomaterial in the double-layer structure can be gradually degraded and absorbed by the body, transforming into small molecules that are harmless to the body, thereby reducing the space-occupying effect. Furthermore, the double-layer helical structure incorporates fixation components, and the reasonable connections and fixation between different components ensure that the fixation components and the double-layer structure are essentially coaxial or axially parallel, effectively improving the operability for doctors during the use of the embolization.

[0055] The following description, in conjunction with the accompanying drawings and several embodiments, further illustrates the embolic material and its preparation method proposed in this invention.

[0056] Figure 1 This is a partial cross-sectional view of the embolic device 10 according to the first embodiment of the present invention. Figure 2 yes Figure 1The figure shows a cross-sectional view of the embolic member 10. As shown, the embolic member 10 is in its linear primary shape, and is a relatively long, elongated device extending from its proximal end 160 to its distal end 140. The proximal end 160 of the embolic member 10 is configured to be connected to a pushing device (not shown) of the embolic member 10. The embolic member 10 includes a tubular first helical member 100 having an inner cavity 110, a second helical member 120 nested on the outer side of the first helical member 100, and a fixing member 170 at least partially disposed within the inner cavity 110 of the first helical member 100. The first helical member 100, the second helical member 120, and the fixing member 170 are substantially coaxial or axially parallel. The two ends of the fixing member 170 are respectively connected to the two ends of the second helical member 120 for fixing the first helical member 100 and the second helical member 120.

[0057] The first helical component 100 comprises 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 is formed by spirally winding a metal wire made of the aforementioned material around a core post of a predetermined diameter. The pitch of the coil of the first helical component 100 may be uniform, gradually varying along the length of the coil, or may have different pitches in different sections of the coil.

[0058] In some embodiments, the first helical component 100 is a composite material component whose matrix is ​​doped with a developing agent. The developing agent can be an iodine contrast agent or barium sulfate, and the matrix can 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 helically wound onto a mandrel of a predetermined diameter to form the first helical component 100.

[0059] In some embodiments, the second helical 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 helical component 120 may also be modified, for example, by loading some active substances, such as growth factors or certain drug molecules, onto the interior or surface of the second helical component 120. The polymer or metal wire made of the above materials is helically wound on a core post of a predetermined diameter to form the second helical component 120. It is understood that the pitch of the coil of the second helical component 120 may be uniform, may gradually change along the length of the coil, or may have different pitches in different sections of the coil.

[0060] The volume of the second helical component 120, made of bioabsorbable material, accounts for 30-90% of the total volume of the embolization 10. The embolization 10, employing a double-layer structure of bioabsorbable material and opaque metallic material, maintains the good radioactivity and support characteristics of traditional metal coils. The bioabsorbable material portion can be partially degraded and absorbed within a certain time, effectively alleviating problems such as space-occupying effects that may cause compression of surrounding tissues and nerves in large aneurysms.

[0061] In some embodiments, the outer diameter of the first helical component 100 ranges from 0.002 to 0.02 inches, and the cross-section of the filament wound around the first helical component 100 is circular or a portion of a circle, with the diameter or radius of curvature of the filament ranging from 0.0003 to 0.003 inches. The outer diameter of the second helical component 120 ranges from 0.005 to 0.05 inches, and the cross-section of the filament wound around the second helical component 120 is circular or a portion of a circle, with the diameter or radius of curvature of the filament ranging from 0.0005 to 0.005 inches. (Continue to refer to...) Figure 1 and Figure 2 The second helical component 120 covers the outside of the first helical component 100, and the axial length of the first helical component 100 is not greater than the axial length of the second helical component 120. The length of the second helical component 120 ranges from 0.5 to 200 cm, and the length of the first helical component 100 is slightly shorter than the length of the second helical component 120, which is 10% to 100% of the length of the tubular structure formed by the second helical component 120.

[0062] like Figure 2 As shown, the fixing component 170 can be a polymer filament, and the material used to make 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 component 100 and the second spiral component 120 by physical winding or knotting, respectively, to fix the first spiral component 100 and the second spiral component 120.

[0063] In some embodiments, the fixing member 170 is knotted with the first helical member 100 and the second helical member 120 by simultaneously knotting at least one turn of the first helical member 100 and at least one turn of the second helical member 120, to keep the first helical member 100 and the second helical member 120 substantially coaxial or axially parallel. It is understood that the connection position of the fixing member 170 with the first helical member 100 and / or the second helical member 120 is not limited to... Figure 2As shown, the fixing member 170 can be knotted at any position on the circumference of the spiral member. In some other embodiments, the fixing member 170 is knotted with the first spiral member 100 and the second spiral member 120 by first knotting the fixing member 170 with at least one spiral turn on the inner circle of the first spiral member 100, and then knotting the fixing member 170 with at least one spiral turn on the outer circle of the second spiral member 120.

[0064] In some embodiments, the knotting method between the fixing member 170 and the first spiral member 100 and the second spiral member 120 may also be: at both ends of the first spiral member 100 and the second spiral member 120, the fixing member 170 knots only 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.

[0065] Continue to refer to Figure 2 A non-invasive distal tip is formed at the distal end 140 of the first helical component 100 and the second helical component 120 by hot melting or dispensing, which securely bonds the distal end 177 of the fixing component 170 to at least a portion of the distal end 140 of the first helical component 100 and the second helical component 120 together. This non-invasive distal tip can be... Figure 2 The ball cap 150 shown may also be a conical or elliptical closed end, with at least a portion of the distal ends 140 of the first helical component 100 and the second helical component 120 encased in the ball cap 150. This non-invasive 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 embodiments, at least a portion of the fixing component 170 knotted on the second helical component 120 is also encased in the ball cap 150. In other embodiments, the proximal ends 160 of the first helical component 100 and the second helical component 120 may also be formed into non-invasive distal tips by hot-melt or dispensing, securely bonding the proximal end 179 of the fixing component 170 to at least a portion of the proximal end 160 of the first helical component 100 and / or the second helical component 120.

[0066] Figure 3This is a cross-sectional view of the embolic member 10 according to a second embodiment of the present invention. The embolic member 10 includes a tubular first helical component 100 having an inner cavity 110, a second helical component 120 nested on the outer side of the first helical component 100, and a fixing component 170 at least partially disposed within the inner cavity 110 of the first helical component 100. The first helical component 100 includes a first helical unit 102 and a second helical unit 104 that are substantially coaxial or axially parallel. In some embodiments, the fixing component 170 is a polymer filament that passes through the inner cavities of the first helical unit 102 and the second helical unit 104, respectively. Portions 171, 173, and 175 of the polymer filament extending out of the first helical unit 102 and the second helical unit 104 are respectively connected to corresponding positions on the second helical component 120 to fix the first and second helical units 102, 104, and the second helical component 120. It is understood that the first helical component 100 may have three, four, five, or more helical units.

[0067] Figure 4 This is a cross-sectional view of the embolic member 10 according to a third embodiment of the present invention. The embolic member 10 includes a tubular first helical component 100 having an inner cavity 110, a second helical component 120 nested on the outer side of the first helical component 100, and a fixing component 170 at least partially disposed within the inner cavity 110 of the first helical component 100. The fixing component 170 includes a first curing adhesive 172 and a second curing adhesive 174, disposed between the first helical component 100 and the second helical component 120, and at least partially disposed within the inner cavity 110 of the first helical component, for fixing the first helical component 100 and the second helical component. In the illustrated embodiment, the first curing adhesive 172 and the second curing adhesive 174 are respectively disposed at both ends of the second helical component 120, covering at least a portion of both ends of the first helical component 100, for fixing the first helical component 100 to the second helical component 120. It is understood that the first curing adhesive 172 and the second curing adhesive 174 are formed by dispensing adhesive on the outside of the second spiral component 120. The first curing adhesive 172 can be formed by dispensing adhesive around the second spiral component 120 once, or by dispensing adhesive on at least one point on the outside of the second spiral component 120.

[0068] In some embodiments, the fixing component further includes a third curing adhesive, which can be disposed at any position between the first curing adhesive 172 and the second curing adhesive 174, and coupled to the first spiral component 100 and the second spiral component 120 respectively, for fixing the first spiral component 100 to the second spiral component 120.

[0069] Figure 5 This is a cross-sectional view of the embolus 10 according to the fourth embodiment of the present invention. Figure 3The illustrated embodiment is similar, with the first helical component 100 comprising a first helical unit 102, a second helical unit 104, and a third helical unit 106 that are substantially coaxial or axially parallel. In this case, the fixing component 170 may include a first curing adhesive 172, a second curing adhesive 174, and a third curing adhesive 176. The first and second curing adhesives 172 and 174 are respectively disposed between the two ends of the second helical component 120 and the first and second helical units 102 and 104, respectively, to fix the first and second helical units 102 and 104 to the second helical component 120. Simultaneously, the third curing adhesive 176 is disposed between the second helical component 120 and the third helical unit 106, to fix the third helical unit 106 to the second helical component 120. In other embodiments, the number of helical units and curing adhesives is not limited to this.

[0070] Figure 6 This is a cross-sectional view of the embolic device 10 according to the fifth embodiment of the present invention. The embolic device 10 includes a tubular first helical component 100 having an inner cavity 110, a second helical component 120 nested on the outer side of the first helical component 100, a shaping component 130 at least partially disposed in the inner cavity 110 of the first helical component 100, and a fixing component 170 at least partially disposed in the inner cavity 110 of the first helical component 100. The structure and usage of the first helical component 100, the second helical component 120, and the fixing component 170 are similar to those of the present invention. Figure 2 The embodiments shown are largely the same and will not be described again here. In some embodiments, the shaping component 130 and the first spiral component 100 are substantially coaxial or axially parallel.

[0071] like Figure 6 As shown, the distal end 132 of the shaping component 130 is fixed to the distal end 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 disposed in the proximal cavity 110 of the first spiral component 100. In one embodiment of this application, the distal end 132 of the shaping component 130 is configured as an inverted J-shaped hook, connected to at least one coil of the distal end 140 of the first spiral component 100, such as the last coil. Then, a non-traumatic distal tip is formed on the distal end 140 of the first spiral component 100 and the second spiral component 120 by hot melting or dispensing, firmly bonding the distal end 132 of the shaping component 130 to the distal end 140 of the first spiral component 100 and the second spiral component 120 together, that is, at least a portion of the inverted J-shaped hook and the distal end 140 of the first spiral component 100 and the second spiral component 120 are covered by the non-traumatic distal tip. The non-traumatic distal tip can be... Figure 2The spherical cap 150 shown can also be a conical or elliptical closed end. The non-invasive distal tip can be formed of a polymer material, such as polyester, acrylic adhesive, or other polymer materials suitable for hot-melt or dispensing. In other embodiments, the distal end 132 of the shaping component 130 can also be connected to the distal ends 140 of the first helical component 100 and the second helical component 120 in other ways. For example, the distal end 132 of a straight, inverted J-shaped, or other shaped shaping component 130 can be directly wrapped and fixed by the spherical cap 150; or the distal end 132 of the shaping component 130 can be first connected to at least one coil of the second helical component 120 and then wrapped and fixed by the spherical cap 150; or the shaping component 130 can be connected to at least one end of the first helical component 100 and the second helical component 120 by physically winding or knotting threads.

[0072] In some embodiments, the proximal end 134 of the shaping component 130 is connected to the proximal end 160 of the first spiral component 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 component 100, respectively.

[0073] In some embodiments, the shaping component 130 includes at least one shaping filament, each of which has a circular, elliptical, or polygonal cross-section, with a diameter not exceeding 90% of the inner diameter of the first helical component 100, wherein the inner diameter of the first helical component ranges from 0.001 to 0.01 inches. The material forming the shaping component 130 is a shape memory alloy, which may be one or more of cobalt-chromium alloys, nickel-titanium alloys, and platinum-tungsten alloys. The shaping component 130 manufactured using the above materials not only enhances the visibility of the double-layer helical structure in blood vessels and aneurysms but also allows for three-dimensional pre-shaping of the shape memory alloy to improve the stability of the embolic material 10, providing better support within the aneurysm. In some embodiments, the shaping component 130 may be pre-shaped to have at least one secondary structure selected from helical, wavy, tetrahedral, pentahedral, and hexahedral shapes.

[0074] To achieve the above objectives, the present invention also provides a method for preparing the embolic material 10, referring to... Figure 6 It mainly includes the following steps:

[0075] S1, the wound first spiral component 100 and the shaping component 130 are pre-shaped on the mold according to the preset shape. The preset shape can be at least one of spiral, wave, tetrahedron, pentahedron and hexahedron. The preset shapes of the first spiral component 100 and the shaping component 130 are also corresponding to each other.

[0076] S2, the pre-shaped shaping component 130 is disposed in the inner cavity 110 of the pre-shaped first spiral component 100, that is, the filamentous shaping component 130 is inserted into the inner cavity 110 of the first spiral component 100, and at least one end of the shaping component 130 is fixed to at least one end of the first spiral component 100.

[0077] S3, the fixing component 170 is placed in the inner cavity 110 of the first spiral component 100.

[0078] S4, the wound second spiral component 120 is fitted onto the outside of the wound first spiral component 100.

[0079] S5, the fixing component 170 disposed in the inner cavity 110 of the first spiral component 100 is connected to the two ends of the first spiral component 100 and the second spiral component 120 respectively 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 the end, wherein at least a portion of the first spiral component 100 and the shaping component 130 are covered by the ball cap 150.

[0080] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. An embolus comprising a tubular first helical member having an internal lumen, a second helical member nested on the outside of the first helical member, and a fixation member at least partially disposed within the internal lumen of the first helical member, characterized in that, The first spiral member comprises radiopaque material, the second spiral member comprises bioabsorbable material, and the fixing member is connected to both ends of the second spiral member to fix the first spiral member and the second spiral member. The fixing member is a polymer filament which is connected to both ends of the second spiral member by physical winding or knotting to fix the first spiral member and the second spiral member.

2. The embolus of claim 1, wherein, The first spiral member is a metal member made of one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof.

3. The embolus of claim 1, wherein, The first spiral member is a composite member in which a developing substance is doped in a matrix, wherein the developing substance is iodine contrast agent or barium sulfate, and the matrix is any one or several of polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), poly-p-dioxanone, polycaprolactone, polyurethane, chitosan and hyaluronic acid.

4. The embolus of claim 1, wherein, The second spiral member is any one or several of polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), poly-p-dioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium, magnesium alloy, iron and iron alloy.

5. The embolus of claim 1, wherein, The polymer filament is any one or several of polypropylene, nylon, polyester, polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid) and polycaprolactone.

6. The embolus of claim 1, wherein, The two ends of the polymer filament are connected to the two ends of the first spiral member and the second spiral member by knotting.

7. The embolus of claim 1, wherein, The polymer filament is knotted on at least one spiral of the first spiral member and at least one spiral of the second spiral member.

8. The embolus of claim 1, wherein, The polymer filament knotted on at least one spiral of the first spiral member and at least one spiral of the second spiral member to keep the first spiral member and the second spiral member coaxial or axially parallel.

9. The embolus of claim 1, wherein, The first spiral member comprises a first spiral unit and a second spiral unit which are coaxial or axially parallel.

10. The embolus of claim 9, wherein, The fixing member is a polymer filament which passes through the inner cavities of the first spiral unit and the second spiral unit, wherein the part of the polymer filament which passes out of the first spiral unit and the second spiral unit is connected to the second spiral member to fix the first and second spiral units and the second spiral member.

11. The embolus of claim 1, wherein, The first spiral member and the second spiral member are coaxial or axially parallel, and / or the axial length of the first spiral member is not greater than the axial length of the second spiral member.

12. The embolus of claim 1, wherein, At least one end of the second spiral member is end-capped by forming a ball cap by hot melting or dispensing, wherein the end of the first spiral member is also covered in the ball cap.

13. The embolus of claim 12, wherein, At least part of the fixing member close to the end of the second spiral member is also covered in the ball cap.

14. The embolus of claim 12, further comprising a shaping member which is at least partially placed in the inner cavity of the first spiral member, one end of the shaping member being covered in the ball cap.

15. The embolus of claim 14, wherein, The shaping member comprises at least one shaping wire, wherein each of the shaping wires has a circular, elliptical or polygonal cross section.

16. The embolus of claim 14, wherein, The material of the shaping member is any one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

17. The embolus of claim 14, wherein, The shaping member has at least one secondary shaping structure selected from the group consisting of helix, wave, tetrahedron, pentahedron and hexahedron.

18. The embolus of claim 14, wherein, The fixing member is connected to the two ends of the second helical member by physical winding or knotting. One end of the shaping member is fixed to one end of the first and second helical members; and At least one end of the second helical member is sealed by forming a ball cap through hot melting or dispensing, and at least part of the first helical member and the shaping member is covered by the ball cap.

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