CN112754583B

CN112754583B - Spring ring and preparation method thereof

Info

Publication number: CN112754583B
Application number: CN202011636795.7A
Authority: CN
Inventors: 杨瑞; 蔡亮; 潘光亮
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2022-04-15
Anticipated expiration: 2040-12-31
Also published as: CN112754583A

Abstract

The invention relates to a spring ring and a preparation method thereof. The coil includes a degradable embolic coil, a visualization coil disposed within the embolic coil, and a plurality of induction units disposed on the embolic coil for inducing vascular cells to adhere to the embolic coil. A plurality of induction units on the embolic coil of this spring coil can induce vascular cell to adhere to on the embolic coil, so compare the spring coil of this application with current spring coil and changeing and arouse vascular cell to adhere, realize human initiative degradation to the embolic coil under vascular cell's effect, can greatly shorten the degradation cycle of embolic coil, avoid the long-term potential safety hazard after the implantation and can relieve the occupy-place effect completely, also can solve different patient individuality and the degradation cycle that leads to and the poor problem of disease cure cycle matching nature.

Description

Spring ring and preparation method thereof

Technical Field

The invention relates to the technical field of medical devices, in particular to a spring ring and a preparation method thereof.

Background

With the improvement of domestic living standards and the progress of medical diagnosis technologies, the incidence of vascular diseases caused by abnormal changes of blood vessels or aging and other factors is also increasing year by year, and the manifestations of the diseases include intracranial aneurysm, visceral aneurysm, peripheral aneurysm, arteriovenous malformation, hemangioma and the like. For the diseases, the treatment schemes adopted at home and abroad mainly comprise surgical treatment and interventional treatment. Because of the great trauma and a series of complications which can be caused by surgical treatment, an intravascular interventional minimally invasive treatment scheme becomes a preferred scheme for treating the vascular diseases. The spring ring is one of important implants of an intravascular interventional minimally invasive treatment scheme, is mainly used for embolizing in an aneurysm or a malformed blood vessel to change the hemodynamics, and realizes complete embolization or thrombosis so as to achieve the treatment purpose.

The current spring rings are mainly divided into three types: the first type is a pre-shaped bare metal spring ring, such as a spring ring of Axium Prime, which is prefabricated into a two-dimensional or three-dimensional structure by adopting platinum-tungsten alloy materials; the second is a biological modification spring ring with a surface covered with a bioactive material, such as a spring ring Matrix, the surface of the metal ring is covered with a PLGA biological material, and the PLGA has biodegradable performance, can be absorbed by the body and can reduce the space occupying effect; the third is a high-expansibility hydrogel spring ring, such as a hydrogel ring Hydrocoil, and the hydrogel is added in the metal ring, so that a large amount of water absorption volume of the hydrogel is greatly expanded after the hydrogel is implanted, the spring ring is completely filled in the cavity, and the recanalization rate of the aneurysm is reduced.

The three types of spring rings, namely the naked metal spring ring and the biological modification spring ring and the hydrogel spring ring prepared on the basis of the naked metal spring ring, can treat related diseases after being filled, but still remain in the body for a long time due to a large amount of residual metal, and the problems of long-term safety, space occupying effect and the like are not completely solved. If the spring ring is simply made of degradable material, the degradation period and the disease curing period can not be perfectly matched due to individual difference of each patient and influence of other external environmental factors.

Therefore, a new spring coil and method of making the same are needed to address at least the above-mentioned problems.

Disclosure of Invention

In view of the above, there is a need to provide a spring coil and a method for making the same.

A spring coil, the spring coil comprising: the device comprises a degradable embolic coil, a developing coil arranged in the embolic coil and a plurality of inducing units arranged on the embolic coil, wherein the inducing units are used for inducing vascular cells to be adhered to the embolic coil.

In one embodiment, the inducing unit is a convex structure, the convex structure is a degradable material, and the specific surface area of the convex structure is larger than that of the embolic coil.

A spring coil, the spring coil comprising: the embolic coil is made of degradable materials, and the specific surface area of the protruding structure is larger than that of the embolic coil.

In one embodiment, the total volume of the raised structures is 0.01% -1% of the volume of the embolic coil.

In one embodiment, the raised structures are disposed in the inner surface, and/or the outer surface, and/or the inter-turn gaps of the embolic coil.

In one embodiment, the length L of the raised structures in the axial direction of the embolic coil is 10 μm-500 μm.

In one embodiment, the protrusion structure includes: the plug coil comprises a plurality of protruding structure groups arranged at intervals along the axial direction of the plug coil, wherein the protruding structure groups are distributed along the circumferential direction of the plug coil, and the number of the protruding structures of each protruding structure group is 10-1000.

In one embodiment, the shape of the protruding structure is a hemisphere, a cone or a cylinder, or the longitudinal cross-sectional shape of the protruding structure is a fusiform.

In one embodiment, the protruding structure is integrally formed with the embolic coil by welding or bonding.

In one embodiment thereof, the spring ring further comprises: and the developing piece is arranged in the embolism coil and is at least one of a developing coil and a developing wire.

In one embodiment, the developing silk has a silk number of 4-12.

A method of making a spring coil, the method comprising:

preparing an embolic coil by adopting a degradable material;

and arranging a plurality of convex structures on the embolic coil, wherein the convex structures are degradable materials, and the specific surface area of the convex structures is larger than that of the embolic coil.

In one embodiment, the disposing a plurality of raised structures on the embolic coil comprises: and forming a convex structure on the embolic coil in an integrated forming mode.

In one embodiment, the integral molding manner includes cutting, etching, hot melting or additive manufacturing.

In one embodiment, the embolic coil is cut with a laser.

In one embodiment, the disposing a plurality of raised structures on the embolic coil comprises:

the raised structure is obtained and then connected to the embolic coil.

In one embodiment, the protruding structure is connected to the embolic coil by welding or bonding.

In one embodiment thereof, the preparation method further comprises: a visualization is acquired and disposed within the embolic coil.

A method of making a spring coil, the method comprising:

preparing the embolism core wire by adopting degradable materials;

arranging a plurality of convex structures on the embolic core wire, and then manufacturing the embolic core wire into an embolic coil, wherein the convex structures are degradable materials, and the specific surface area of the convex structures is larger than that of the embolic coil.

In one embodiment, the disposing a plurality of raised structures on the embolic core wire comprises: and forming the convex structure on the plug core wire in an integrated forming mode.

In one embodiment, the integral molding is cutting, etching, hot melting or additive manufacturing.

In one embodiment, the core wire is cut with a laser.

In one embodiment, the disposing a plurality of raised structures on the embolic core wire comprises:

the raised structure is obtained and then connected to the embolic core wire.

In one embodiment, the protruding structure is connected to the plug core wire by welding or bonding.

According to the spring coil and the preparation method thereof, the plurality of induction units on the embolic coil can induce the vascular cells to adhere to the embolic coil, so that compared with the conventional spring coil, the spring coil is easier to cause the vascular cells to adhere, and the active degradation of the human body to the embolic coil is realized under the action of the vascular cells, instead of simply utilizing the degradation characteristic of the embolic coil to wait for degradation in an inert manner, the degradation period of the embolic coil can be greatly shortened, the long-term potential safety hazard after implantation is avoided, the occupation effect can be completely eliminated, the factors influencing the degradation period can be partially transferred to each receptor, therefore, the vascular cell driven degradation and the matching of the intimal growth period and the endothelialization period with the degradation period are realized, the problem of poor matching of the degradation period and the disease curing period caused by individual difference of different patients is solved, and the aneurysm can be cured earlier and more adaptively. It is noted that the spring ring immediately plays a role in embolization of aneurysm after implantation, the intima and endothelialization occur synchronously in the process of starting degradation, and the aneurysm disappears after the spring ring is completely degraded, and replaces the aneurysm with a normal blood vessel wall, so that the occupation effect is eliminated and the long-term potential safety hazard is eliminated.

Drawings

FIG. 1 is a schematic diagram of a spring coil according to an embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is a schematic diagram of a spring coil according to another embodiment of the present invention;

fig. 4 is a partially enlarged view of fig. 3.

FIG. 5 is a schematic diagram of a spring coil according to an embodiment of the present invention;

FIG. 6 is an enlarged view of a portion of FIG. 5;

FIG. 7 is a schematic half-section view of a spring coil provided in accordance with an embodiment of the present invention;

FIG. 8 is a schematic half-section view of a spring turn provided in accordance with another embodiment of the present invention;

FIG. 9 is a schematic flow chart illustrating a method of making a spring coil according to one embodiment of the present invention;

FIG. 10 is a schematic flow chart illustrating a method of making a spring coil according to another embodiment of the present invention.

Wherein the reference numerals in the drawings are as follows:

100. an embolic coil; 100a, gaps among the rings; 200. a raised structure; 300. a developing member.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

As shown in fig. 1-6, one embodiment of the present invention provides a spring coil comprising: the embolic coil 100 is degradable, the development coil is arranged in the embolic coil 100, and a plurality of inducing units are arranged on the embolic coil 100 and used for inducing the adhesion of blood vessel cells on the embolic coil 100.

As the spring coil is described above, the plurality of inducing units on the embolic coil 100 can induce the adhesion of the blood vessel cells on the embolic coil 100, so that the spring coil of the present application is more likely to cause the adhesion of the blood vessel cells than the existing spring coils, and the active degradation of the human body to the embolic coil 100 is realized under the action of the blood vessel cells, instead of simply utilizing the degradation characteristic of the embolic coil 100 to wait for degradation in an inert manner, the degradation period of the embolic coil 100 can be greatly shortened, the long-term potential safety hazard after implantation can be avoided, the occupation effect can be completely eliminated, the factors influencing the degradation period can be partially transferred to each receptor, therefore, the vascular cell driven degradation and the matching of the intimal growth period and the endothelialization period with the degradation period are realized, the problem of poor matching of the degradation period and the disease curing period caused by individual difference of different patients is solved, and the aneurysm can be cured earlier and more adaptively. It is noted that the spring ring immediately plays a role in embolization of aneurysm after implantation, the intima and endothelialization occur synchronously in the process of starting degradation, and the aneurysm disappears after the spring ring is completely degraded, and replaces the aneurysm with a normal blood vessel wall, so that the occupation effect is eliminated and the long-term potential safety hazard is eliminated.

In some embodiments of the present invention, as shown in fig. 1 to 6, the inducing unit is a protrusion structure 200, the protrusion structure 200 is a degradable material, and the specific surface area of the protrusion structure 200 is larger than that of the embolic coil 100. Compared with the embolic coil 100, the convex structure 200 has larger specific surface area per se, larger contact area with body fluid in a diseased vessel, more easy degradation and absorption, earlier degradation by utilizing the biological activity of an absorbable material, easy adhesion and proliferation effect of vascular cells caused by degradation products, and capability of planting the vascular cells on each convex structure 200 on the embolic coil 100 before the degradation of the embolic coil 100, so that the spring ring provided by the embodiment of the invention can greatly shorten the degradation period of the embolic coil 100 through the synergistic effect of the degradation of the convex structures 200 and the degradation of the embolic coil 100, avoid the long-term potential safety hazard after the implantation and completely eliminate the occupation effect, and can also transfer part of factors influencing the degradation period to each receptor, thereby realizing the driven degradation of the vascular cells, the matching of intimal growth and endothelialization periods with the degradation period, solves the problem of poor matching between the degradation period and the disease curing period caused by individual difference of different patients, and can cure the aneurysm earlier and more adaptively. The material, shape, number and distribution position of the protrusion structures, and the material and size parameters of the embolic coil 100 and the developing coil are described in detail below, and are not described herein again.

As shown in fig. 1 to 6, an embodiment of the present invention provides a spring coil, which includes an embolic coil 100 and a plurality of protruding structures 200 disposed on the embolic coil 100, wherein both the embolic coil 100 and the protruding structures 200 are made of degradable material, and the specific surface area of the protruding structures 200 is larger than that of the embolic coil 100. The specific surface area according to the embodiment of the present invention is a ratio between an area and a volume, and the larger the specific surface area, the larger the contact area with the body fluid in the lesion blood vessel.

Compared with the embolic coil 100, the spring ring, the convex structure 200 has a larger specific surface area per se and a larger contact area with body fluid in a diseased vessel, so that the spring ring is more easily degraded and absorbed, can be degraded earlier by using the biological activity of the absorbable material, the degradation product is easy to cause vascular cell adhesion and proliferation effect, and the vascular cells can be planted on each convex structure 200 on the embolic coil 100 before the embolic coil 100 is degraded, so that the human body can actively degrade the embolic coil 100 under the action of the vascular cells, rather than simply waiting for degradation in an inert manner by using the degradation characteristic of the embolic coil 100. Therefore, the spring ring provided by the embodiment of the invention can greatly shorten the degradation period of the embolic coil 100 through the synergistic effect of the degradation of the convex structure 200 and the degradation of the embolic coil 100, avoid the long-term potential safety hazard after implantation and completely eliminate the occupation effect, and can partially transfer the factors influencing the degradation period to each receptor, thereby realizing the driving degradation of vascular cells, matching the degradation period of the intimal growth and the endothelialization period, solving the problem of poor matching of the degradation period and the disease cure period caused by the individual difference of different patients, and being capable of curing the aneurysm earlier and more conformably. It is noted that the spring ring immediately plays a role in embolization of aneurysm after implantation, the intima and endothelialization occur synchronously in the process of starting degradation, and the aneurysm disappears after the spring ring is completely degraded, and replaces the aneurysm with a normal blood vessel wall, so that the occupation effect is eliminated and the long-term potential safety hazard is eliminated.

In some embodiments of the present invention, the total volume of the raised structures 200 may be 0.01% to 1% of the volume of the embolic coil 100, for example, the percentage may be set to 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.10%, 0.50%, 1%, etc. It should be noted that the total volume of the raised structures 200 refers to the sum of the volumes of all the raised structures 200 on the embolic coil 100. The range of the total volume of the protruding structures 200 in percentage of the volume of the embolic coil 100 is set in this way, so that the protruding structures 200 can be degraded earlier than the embolic coil 100, and the pushing of the embolic coil 100 is facilitated.

In some embodiments of the invention, the raised structures 200 are disposed on the inner surface, and/or the outer surface, of the embolic coil 100, and/or in the inter-turn gaps 100a shown in fig. 2, 4, and 6. It should be noted that the inner and outer surfaces of the embolic coil 100 herein refer to the inner and outer surfaces of the embolic coil 100 under compaction, respectively, and the inter-loop gap 100a refers to the gap between two adjacent loops in the embolic coil 100. Therein, the projection structures 200 shown in fig. 1 to 6 are all provided in the inter-turn slit 100a of the embolic coil 100.

Alternatively, as shown in FIG. 6, the length L of the projection structure 200 in the axial direction of the embolic coil 100 is 10 μm to 500 μm, and may be set to 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 100 μm, 300 μm, 500 μm, or the like, for example. By setting the range of the length L of the protruding structure 200 in the axial direction of the embolic coil 100, when the protruding structure 200 is disposed in the inter-annular gap 100a of the embolic coil 100, it can be ensured that the protruding structure 200 is degraded earlier than the embolic coil 100, and it can also be avoided that the inter-annular gap 100a of the embolic coil 100 is too large, thereby facilitating the pushing of the embolic coil 100.

Alternatively, as shown in fig. 1 to 6, the protrusion structure 200 includes: the plurality of protrusion structure groups are arranged at intervals along the axial direction of the embolic coil 100, the protrusion structure groups are distributed along the circumferential direction of the embolic coil 100, and the number of the protrusion structures of each protrusion structure group is 10-1000 (for example, 10, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, etc.). The range of the number of the protruding structures of each protruding structure group is set in this way, so that when the protruding structures 200 are arranged in the gaps 100a between the loops of the embolic coil 100, the protruding structures 200 can be degraded earlier than the embolic coil 100, and the friction force between the protruding structures 200 can be prevented from being too large, thereby being beneficial to pushing the embolic coil 100.

The protruding structure groups may be disposed at the proximal end and the distal end of each turn of the embolic coil 100, that is, two turns of protruding structures 200 (i.e., two protruding structure groups) arranged in parallel are disposed on each inter-turn gap 100a of the embolic coil 100 shown in fig. 1 to 6. Thus, the number of the protruding structures 200 on the embolic coil 100 can be increased, the degradation period of the embolic coil 100 can be further shortened, the long-term potential safety hazard after implantation can be effectively avoided, and the space occupying effect can be completely eliminated. When preparing the coil, a plurality of raised structures 200 may be spaced apart along the length of the embolic core wire on both edges of the embolic core wire, and then the embolic core wire is wound on a mandrel to form the embolic coil 100. Alternatively, the two circles of raised structures 200 in each inter-circle gap 100a may be distributed in a staggered manner or in an aligned manner as shown in fig. 2, 4 and 6.

In some embodiments of the invention, the shape of the protruding structure 200 is hemispherical as shown in fig. 4, conical as shown in fig. 2, cylindrical as shown in fig. 6, or the longitudinal cross-sectional shape of the protruding structure 200 is fusiform. Of course, in other embodiments of the present invention, the shape of the convex structure 200 may be a polygonal prism or an irregular shape.

In some embodiments of the present invention, the connection between the protrusion structure 200 and the embolic coil 100 is formed integrally, welded or bonded. The integral molding may be cutting (e.g., laser cutting), etching, additive manufacturing (i.e., 3D printing), or thermal melting.

In some embodiments of the invention, the raised structures 200 may be the same or different material as the embolic coil 100. When the raised structure 200 is connected to the embolic coil 100 in an integrally formed manner, the raised structure 200 is made of the same material as the embolic coil 100; when other connection methods are used, the protruding structure 200 and the embolic coil 100 may be made of the same material or different materials.

Alternatively, the material (i.e., degradable material) of the raised structures 200, the embolic coil 100 may be selected from at least one of lactic acid (PLA), L-polylactic acid (PLLA or LPLA), polyglycolic acid/polylactic acid copolymer (PGLA), Polycaprolactone (PCL), polydioxanone (PPDO). The degradation time of the degradable material may be 7 days to 60 days (for example, 7 days, 10 days, 20 days, 30 days, 40 days, 50 days, 60 days, etc.), and preferably 30 days. The range of the degradation time of the degradable material can meet clinical requirements, and as for the effect after filling, the shorter the degradation time is absorbed, the earlier the occupying time of the spring ring is removed, and the fewer adverse consequences brought to patients are.

In some embodiments of the present invention, as shown in fig. 7 and 8, the spring coil further comprises: a developer 300 disposed within the embolic coil 100. The developer member 300 allows for precise positioning of the coils. It is understood that the development member 300 is a radiopaque material, such as at least one selected from the group consisting of platinum, rhenium, tungsten, tantalum, gold, silver, and the like.

Specifically, in some embodiments of the present invention, the developing member 300 is at least one of the developing coil illustrated in fig. 7 and the developing wire illustrated in fig. 8.

Alternatively, as shown in fig. 7, the embolic coil 100 has a wire diameter D1 of 0.00001 inch to 0.008 inch (e.g., can be 0.00001 inch, 0.0005 inch, 0.001 inch, 0.002 inch, 0.003 inch, 0.004 inch, 0.005 inch, 0.006 inch, 0.007 inch, 0.008 inch, etc.), preferably 0.0008 inch to 0.002 inch (e.g., can be 0.0008 inch, 0.0009 inch, 0.001 inch, 0.002 inch, etc.). As shown in fig. 7, the developing coil and developing wire have a wire diameter D2 of 0.00001 inch to 0.008 inch (for example, 0.00001 inch, 0.0005 inch, 0.001 inch, 0.002 inch, 0.003 inch, 0.004 inch, 0.005 inch, 0.006 inch, 0.007 inch, 0.008 inch, etc.), and preferably 0.0008 inch to 0.004 inch (for example, 0.0008 inch, 0.0009 inch, 0.001 inch, 0.002 inch, 0.003 inch, 0.004 inch, etc.).

Alternatively, the number of developing filaments is 4 to 12 (e.g., 4, 6, 8, 10, 12, etc.), preferably 6. The silk number scope of developing silk so set up both can reach the development effect, also can utilize the propelling movement of spring coil.

Alternatively, the width of the inter-turn gap of the developing coil is 0.001 inch to 0.01 inch, such as 0.001 inch, 0.002 inch, 0.003 inch, 0.004 inch, 0.008 inch, 0.01 inch, and the like. The winding angle of the developing coil is 60-90 degrees, such as 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees and the like. The width of the inter-turn gap of embolic coil 100 is 0.0008 inches to 0.008 inches, such as 0.0008 inches, 0.001 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.008 inches, and so forth. The winding angle of the embolic coil 100 is 60 ° -90 °, such as 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, 90 °, and the like.

Optionally, the volume ratio of the embolic coil 100 to the visualization element 300 is (10-50: 1), for example, 10:1, 20:1, 30:1, 40:1, 50:1, etc., preferably 20: 1. The range of the volume ratio of the embolic coil 100 to the developing member 300 is set in this way, so that the developing member 300 can achieve the developing effect and is beneficial to pushing the spring ring.

Alternatively, the two ends of the development coil and the development wire may be connected to the embolic coil 100 by welding or bonding.

Another embodiment of the present invention also provides a method for manufacturing a spring coil, as shown in fig. 9, the method including:

s100, preparing and obtaining the embolic coil 100 by adopting degradable materials;

step S200, arranging a plurality of convex structures 200 on the embolic coil 100, wherein the convex structures 200 are degradable materials, and the specific surface area of the convex structures 200 is larger than that of the embolic coil 100.

Compared with the embolic coil 100, the spring coil obtained by the preparation method has the advantages that the convex structures 200 have larger specific surface area per se and larger contact area with body fluid in a diseased vessel, so that the spring coil is more easily degraded and absorbed, the biological activity of absorbable materials can be utilized to degrade earlier, the degradation products are easy to cause vascular cell adhesion and proliferation effects, vascular cells can be planted on each convex structure 200 on the embolic coil 100 before the embolic coil 100 is degraded, and the human body can actively degrade the embolic coil 100 under the action of the vascular cells instead of simply utilizing the degradation characteristic of the embolic coil 100 to wait for degradation in an inert manner. Therefore, the spring ring prepared by the preparation method provided by the embodiment of the invention can greatly shorten the degradation period of the embolic coil 100 through the synergistic effect of the degradation of the convex structure 200 and the degradation of the embolic coil 100, avoid the long-term potential safety hazard after implantation and completely eliminate the occupation effect, and can partially transfer the factors influencing the degradation period to each receptor, thereby realizing the vascular cell driven degradation, matching the degradation period of the intima growth and the endothelialization period, solving the problem of poor matching of the degradation period and the disease healing period caused by the individual difference of different patients, and being capable of healing the aneurysm earlier and more conformably.

For step S100, the step S100 includes: the embolic core wire is wound around a core rod to form an embolic coil 100, and then a setting process is performed on a mold in a predetermined shape. Here, the step of the sizing process may be performed after step S200.

Regarding step S200, in some embodiments of the present invention, step S200 includes: the raised structures 200 are formed on the embolic coil 100 by integral molding.

Specifically, the step S200 includes: the embolic coil 100 is cut, etched, heat fused, or additively manufactured to form the raised structures 200 on the surface of the embolic coil 100. Optionally, cutting, etching or additive manufacturing may be performed at the edge of each coil of the embolic coil 100 to form the raised structures 200 in the inter-turn gaps 100a of the embolic coil 100. Alternatively, the embolic coil 100 can be cut with a laser.

Regarding step S200, in some other embodiments of the present invention, step S200 includes: the raised structure 200 is acquired and then the raised structure 200 is connected to the embolic coil 100.

Specifically, the step S200 includes: the raised structures 200 are disposed on the embolic coil 100 by welding or bonding.

In some embodiments of the invention, the method of preparing further comprises: step 300, acquiring a developing member 300, and disposing the developing member in the embolic coil 100. The developing member 300 is at least one of a developing coil and a developing wire, and both ends of the developing member 300 can be connected to the embolic coil 100 by welding or bonding, wherein the developing coil is prepared by the same process as the embolic coil 100.

Another embodiment of the present invention also provides a method for manufacturing a spring coil, as shown in fig. 10, the method including:

s100, preparing the embolism core wire by adopting a degradable material;

step S200, arranging a plurality of protruding structures 200 on the embolic core wire, and then manufacturing the embolic core wire into the embolic coil 100, wherein the protruding structures 200 are made of degradable materials, and the specific surface area of the protruding structures 200 is larger than that of the embolic coil 100.

With respect to step S200, in some embodiments of the present invention, the raised structure 200 may be formed on the core wire in an integral manner.

Specifically, the step S200 includes: the core plug wire is cut, etched, heat fused or additively manufactured to form the raised structures 200 on the surface of the core plug wire. Optionally, the edges of each loop of embolic core wire may be cut, etched, or additively manufactured to form the raised structures 200 in the inter-loop gaps 100a of the embolic core wire. Alternatively, the embolic core wire may be cut with a laser.

With respect to step S200, in other embodiments of the present invention, the raised structure 200 may be obtained first, and then the raised structure 200 is connected to the plug wire.

Specifically, the step S200 includes: the raised structure 200 is placed on the core wire by welding or gluing.

In addition, regarding step S200, in some other embodiments of the present invention, after the protrusion structure 200 is disposed on the plug wire, the plug wire is wound on the mandrel to form the plug coil 100, and then the setting process is performed on the mold according to the preset shape.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A spring coil, comprising: the embolic coil (100) comprises a degradable embolic coil (100), a developing coil arranged in the embolic coil (100) and a plurality of inducing units arranged on the embolic coil (100), wherein the specific surface area of the inducing units is larger than that of the embolic coil (100), the inducing units are used for inducing vascular cells to adhere to the embolic coil (100) to drive the embolic coil (100) to actively degrade, and the embolic coil (100) is selected from at least one of polylactic acid, L-polylactic acid and polyglycolic acid/polylactic acid copolymer.

2. A spring ring as claimed in claim 1, characterized in that the inducing unit is a protruding structure (200), the protruding structure (200) being a degradable material.

3. A spring coil, comprising: the embolic coil (100) and a plurality of protruding structures (200) arranged on the embolic coil (100), wherein the protruding structures (200) are used for inducing vascular cells to adhere to the embolic coil (100) so as to drive the embolic coil (100) to actively degrade, the embolic coil (100) and the protruding structures (200) are both selected from at least one of polylactic acid, L-polylactic acid and polyglycolic acid/polylactic acid copolymer, and the specific surface area of the protruding structures (200) is larger than that of the embolic coil (100).

4. A spring coil as claimed in claim 3, characterized in that the total volume of the raised structures (200) is 0.01-1% of the volume of the embolic coil (100).

5. A spring coil as claimed in claim 3, characterized in that the raised structures (200) are provided in the inner surface, and/or the outer surface, and/or the inter-coil gap (100 a) of the embolic coil (100).

6. A spring ring according to claim 5, characterized in that the length L of the raised structure (200) in the axial direction of the embolic coil (100) is 10-500 μm.

7. A spring ring as claimed in claim 5, characterized in that the raised structure (200) comprises: a plurality of protruding structure groups that set up along the axial interval of embolic coil (100), protruding structure group is followed the circumference of embolic coil (100) distributes, and every protruding structure figure of protruding structure group is 10-1000.

8. A spring ring as claimed in claim 3, characterized in that the shape of the raised structure (200) is hemispherical, conical or cylindrical, or the longitudinal cross-sectional shape of the raised structure (200) is fusiform.

9. A spring coil according to claim 3, characterised in that the connection between the raised formations (200) and the embolic coil (100) is integrally formed, welded or glued.

10. The spring coil of any of claims 3-9, further comprising: a developing member (300) disposed within the embolic coil (100), wherein the developing member (300) is at least one of a developing coil and a developing filament.

11. The spring coil of claim 10, wherein said developer wire has a number of wires from 4 to 12.

12. A method of making a spring coil as set forth in any one of claims 1-11, comprising:

preparing an embolic coil (100) from a degradable material;

disposing a plurality of raised structures (200) on the embolic coil (100), wherein the raised structures (200) are degradable materials and the specific surface area of the raised structures (200) is greater than the specific surface area of the embolic coil (100).

13. The method of claim 12, wherein providing a plurality of raised structures (200) on the embolic coil (100) comprises: and forming a convex structure (200) on the embolic coil (100) in an integrated forming mode.

14. The method for preparing the alloy material of claim 13, wherein the integral molding mode is cutting, etching, hot melting or additive manufacturing.

15. The method of claim 12, wherein providing a plurality of raised structures (200) on the embolic coil (100) comprises:

the raised structure (200) is acquired, after which the raised structure (200) is connected to the embolic coil (100).

16. The method of any one of claims 12-15, further comprising: acquiring a visualization (300), disposing the visualization (300) within the embolic coil (100).

17. A method of making a spring coil as set forth in any one of claims 1-11, comprising:

preparing the embolism core wire by adopting degradable materials;

arranging a plurality of protruding structures (200) on the embolic core wire, and then manufacturing the embolic core wire into an embolic coil (100), wherein the protruding structures (200) are degradable materials, and the specific surface area of the protruding structures (200) is larger than that of the embolic coil (100).