CN112617949A - Spring ring and preparation method thereof - Google Patents
Spring ring and preparation method thereof Download PDFInfo
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- CN112617949A CN112617949A CN202011632845.4A CN202011632845A CN112617949A CN 112617949 A CN112617949 A CN 112617949A CN 202011632845 A CN202011632845 A CN 202011632845A CN 112617949 A CN112617949 A CN 112617949A
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Images
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00902—Material properties transparent or translucent
- A61B2017/00915—Material properties transparent or translucent for radioactive radiation
- A61B2017/0092—Material properties transparent or translucent for radioactive radiation for X-rays
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurosurgery (AREA)
- Surgical Instruments (AREA)
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 adhesion, realize human initiative degradation to the embolic coil under vascular cell's effect, can greatly shorten the degradation cycle of embolic coil, in degradation process, the space that the spring coil occupied is occupied by endothelial vascular cell gradually, the continuous shrink of fibrous tissue makes the aneurysm constantly reduce in the aneurysm, the aneurysm volume reduces, eliminate long-term potential safety hazard and occupy-place effect.
Description
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.
Because the residual metal of the three spring coils still stays in the body for a long time, the problems of long-term safety, space occupying effect and the like of the three spring coils are not completely solved, if the spring coils are simply set into degradable materials, the degradation period and the disease curing period can not be perfectly matched due to the individual difference of each patient and the 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 groove structure.
A spring coil, the spring coil comprising: an embolic coil and a plurality of groove structures disposed on the embolic coil, wherein the embolic coil is a degradable material.
In one embodiment, the total volume of the groove structure is 0.01% to 0.1% of the volume of the embolic coil.
In one embodiment, the groove structure opens on the inner and/or outer surface of the embolic coil.
In one embodiment, the groove structure is shaped like a shuttle, and the length direction of the groove structure is the same as the axial direction of the embolic coil.
In one embodiment, the length of the groove structure is 0.1-1 times of the diameter D1 of the embolic coil, and the width and the depth of the groove structure are both 10-600 μm.
In one embodiment, the groove structure comprises: the groove structure groups are arranged along the axial direction of the embolic coil at intervals, the groove structure groups are distributed along the circumferential direction of the embolic coil, and the number of the groove structures of each groove structure group is 10-1000.
In one embodiment, a coating is arranged in the groove structure, the matrix of the coating is degradable polymer, and at least one of a vascular endothelial growth promoting drug, a growth factor and an anti-inflammatory drug is loaded in the matrix, wherein the degradation period of the degradable polymer is less than or equal to that of the embolic coil.
In one embodiment, the degradable polymer is selected from at least one of polylactic acid, L-polylactic acid, polyglycolic acid/polylactic acid copolymer, polycaprolactone, polyacetylglutamic acid, polyorthoester, polydioxanone, polybutylene succinate, polysebacic acid glyceride, chitosan, and polyvinyl alcohol.
In one of the embodiments, the thickness of the coating is less than the depth of the groove structure.
In one embodiment, the coating has a thickness of 1 μm to 200 μm.
In one embodiment, the total weight of the coating is between 10ug and 2000ug over a length of the embolic coil between 1cm and 70 cm.
In one embodiment thereof, the spring ring further comprises: and the developing piece is arranged in the embolic coil, wherein the developing piece is at least one of a developing coil and a developing wire.
A method of making a spring coil, the method comprising:
preparing an embolic coil by adopting a degradable material;
a plurality of groove structures are formed on the embolic coil.
In one embodiment, the forming a plurality of groove structures on the embolic coil comprises: and forming the groove structure on the embolic coil by cutting, etching, hot melting or additive manufacturing.
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;
forming a plurality of groove structures on the embolic core wire, and then forming the embolic core wire into an embolic coil.
In one embodiment, the forming a plurality of groove structures on the plug core wire comprises: and forming the groove structure on the plug core wire by adopting a cutting, etching, hot melting or additive manufacturing mode.
In one embodiment thereof, the preparation method further comprises: a visualization is acquired and disposed within the embolic coil.
According to the spring ring and the preparation method thereof, the plurality of induction units on the embolic coil of the spring ring can induce vascular cells to be adhered to the embolic coil, so that compared with the existing spring ring, the spring ring is easier to cause vascular cell adhesion, active degradation of a human body to the embolic coil is realized under the action of the vascular cells, the degradation is not simply carried out to wait for degradation in an inert manner by utilizing the degradation characteristic of the embolic coil, the degradation period of the embolic coil can be greatly shortened, in the degradation process, the space occupied by the spring ring is gradually occupied by endothelial vascular cells, the aneurysm is continuously reduced due to continuous contraction of fibrous tissues in the aneurysm, the volume of the aneurysm is reduced, and long-term potential safety hazards and occupation effects are 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 half-section view of a spring coil provided in accordance with an embodiment of the present invention;
FIG. 4 is a schematic half-section view of a spring turn provided in accordance with another embodiment of the present invention;
FIG. 5 is a schematic flow chart illustrating a method of making a spring coil according to one embodiment of the present invention;
FIG. 6 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 groove 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. 1-2, 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 ring, the plurality of inducing units on the embolic coil 100 can induce the vascular cells to adhere to the embolic coil 100, so that compared with the existing spring ring, the spring ring of the present application is more likely to cause the vascular cells to adhere, and thus, under the action of the vascular cells, the active degradation of the embolic coil 100 by the human body is realized, rather than simply using the degradation characteristic of the embolic coil 100 to wait for the degradation in an inert manner, the degradation period of the embolic coil 100 can be greatly shortened, in the degradation process, the space occupied by the spring ring is gradually occupied by the endothelial vascular cells, the aneurysm is continuously reduced due to the continuous contraction of the fibrous tissue in the aneurysm, the volume of the aneurysm is reduced, and the long-term potential safety hazard and the occupation effect are eliminated.
In some embodiments of the present invention, as shown in fig. 1-2, the inducing unit is a groove structure 200. Compared with a smooth structure, the groove structure 200 is easier to induce vascular cell adhesion, can realize vascular cell adhesion more quickly, immediately induces vascular cell adhesion after the spring ring is implanted into a human body, drives the embolic coil 100 to actively degrade and be absorbed by the human body after vascular cells grow in the groove structure 200, and does not simply utilize the degradation characteristic of an absorbable material to remove inertia to wait for degradation. The shape, number, and distribution position of the groove structures 200, 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 and 2, one embodiment of the present invention provides a spring coil comprising: an embolic coil 100 and a plurality of groove structures 200 disposed on the embolic coil 100, wherein the embolic coil 100 is a degradable material.
As an example, the degradable material is at least one selected from polylactic acid (PLA), L-polylactic acid (PLLA or LPLA), polyglycolic acid/polylactic acid copolymer (PGLA), Polycaprolactone (PCL), polydioxanone (PPDO). Optionally, the degradation time of the embolic coil 100 is 5 months to 8 months, preferably 6 months to 7 months. The degradation time of the embolic coil 100 is set in such a way, so that the embolic coil 100 can be completely occluded in the aneurysm, the embolic coil 100 can be degraded after the intima grows completely, and the risk of recurrence of the aneurysm is reduced.
Compared with a smooth structure, the groove structure 200 of the spring ring can more easily induce vascular cell adhesion, the vascular cell adhesion can be realized more quickly, the vascular cell adhesion can be induced immediately after the spring ring is implanted into a human body, vascular cells can be driven to actively degrade and be absorbed by the human body after growing in the groove structure 200, the degradation of the embolic coil 100 can be greatly shortened by not simply utilizing the degradation characteristic of an absorbable material to remove inertia and wait for degradation, the occupied space of the spring ring is gradually occupied by endothelial vascular cells in the degradation process, the fibrous tissues in the aneurysm continuously shrink to continuously shrink the aneurysm, the volume of the aneurysm is reduced, and long-term potential safety hazards and occupation effects are eliminated.
In some embodiments of the present invention, the total volume of the groove structure 200 may be 0.01-0.1% 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%, etc. It should be noted that the total volume of the groove structures 200 refers to the sum of the volumes of all the groove structures 200 on the embolic coil 100. The total volume of the groove structure 200 is set to account for the percentage of the volume of the embolic coil 100, so that the mechanical property of the embolic coil 100 can be ensured, and the adhesion of vascular cells can be effectively induced.
In some embodiments of the invention, the groove structures 200 open on the inner and/or outer surface of the embolic coil 100. The groove structures 200 on the inner and/or outer surfaces of the embolic coil 100 are more conducive to adhesion of vascular cells than the groove structures 200 are opened in the inter-turn gaps 100a (see fig. 1 and 2) of the embolic coil 100. 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. In which the groove structures 200 shown in fig. 1-2 are disposed on the inner and outer surfaces of the embolic coil 100.
In some embodiments of the present invention, as shown in fig. 1 and 2, the groove structure 200 has a shuttle shape, and the length direction of the groove structure 200 is the same as the axial direction of the embolic coil 100. Of course, in other embodiments of the present invention, the shape of the groove structure 200 may also be a circle, a square, etc. The fusiform groove structure 200 is easier to machine on embolic coils 100 with smaller wire diameters than groove structures 200 of other shapes.
Optionally, the length of the groove structure 200 is 0.1-1 times (e.g., may be set to 0.1 times, 0.2 times, 0.3 times, 0.4 times, 0.5 times, 0.6 times, 0.7 times, 0.8 times, 0.9 times, 1 times, etc.) of the filament diameter D1 of the embolic coil 100, and the width and depth of the groove structure 200 are each 10 μm-600 μm (e.g., may be set to 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 100 μm, 300 μm, 600 μm, etc.). The length, width and depth of the groove structure 200 are set in this way, so that the mechanical property of the embolic coil 100 can be ensured, and vascular cell adhesion can be effectively induced.
In some embodiments of the present invention, as shown in fig. 1 and 2, the groove structure 200 includes: the groove structure groups are distributed along the circumferential direction of the embolic coil 100, and the number of the groove structures of each groove structure group is 10-1000. (for example, it may be set to 10, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, etc.). The number of the groove structures of each groove structure group is set in such a way, so that the mechanical property of the embolic coil 100 can be ensured, and the adhesion of vascular cells can be effectively induced.
Optionally, a circle of groove structures 200 is disposed on the inner and outer surfaces of each circle of the embolic coil 100 along the circumferential direction, i.e., two groove structure groups are disposed on each circle of the embolic coil 100. Thus, the number of the groove 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 is effectively avoided, and the occupying effect can be completely eliminated. Alternatively, the two turns of the groove structures 200 on each turn of the embolic coil 100 can be staggered or aligned.
In some embodiments of the present invention, a coating is disposed in the groove structure 200, the matrix of the coating is a degradable polymer, and at least one of a drug for promoting vascular endothelial growth, a growth factor, and an anti-inflammatory drug is loaded in the matrix, wherein the degradation period of the degradable polymer is less than or equal to that of the embolic coil 100. The coating may achieve intimation of the aneurysm and cure it gradually earlier. When in use, the degradation period of the degradation polymer can be controlled so as to control the release rate of the endothelial growth promoting drug, the growth factor and the anti-inflammatory drug (hereinafter, the three components are referred to as the drug for short), the faster the degradation, the faster the release rate of the drug, and vice versa; of course, the release rate of the drug can also be controlled by changing the concentration of the drug or the thickness of the coating, for example, by decreasing the drug content per unit thickness of the coating or increasing the coating thickness, or vice versa. It should be noted here that the groove structures 200 are disposed on the inner and outer surfaces of the embolic coil 100 to facilitate the application of the coating to the groove structures 200 after implantation of the coil in the body.
Alternatively, the degradable polymer is selected from at least one of polylactic acid (PLA), L-polylactic acid (PLLA or LPLA), polyglycolic acid/polylactic acid copolymer (PGLA), Polycaprolactone (PCL), polyacetylglutamic acid (PAGA), Polyorthoesters (POE), polydioxanone (Poly-p-dioxanone, PPDO), polybutylene succinate (Poly (butylene succinate), PBS), polyglycerol sebacate (Poly (glycerol sebacate), PGS), chitosan, polyvinyl alcohol (PVA).
Optionally, the thickness of the coating is less than the depth of the groove structure 200. Therefore, the surface of the embolic coil 100 can be ensured not to be protruded outwards, which is beneficial to pushing the spring ring. Alternatively, the thickness of the coating is 1 μm to 200 μm (e.g., may be set to 1 μm, 5 μm, 10 μm, 15 μm, 20 μm, 100 μm, 200 μm, etc.).
Optionally, the total weight of the coating is 10ug-2000ug, e.g. set to 10ug, 100ug, 500ug, 1000ug, 1500ug, 2000ug, etc., within the range of 1cm-70cm of the embolic coil 100 length. It should be noted that the total weight of the coating is the sum of the weights of the coatings in all of the groove structures 200 on the embolic coil 100. The length of the embolic coil 100 is generally between 1cm and 70cm, and for an embolic coil 100 with a length of 1cm, if the total weight of the coating is less than 10ug, the effect of the coating is deteriorated; for an embolic coil 100 70cm long, if the total weight of the coating is greater than 2000ug, it may cause endothelial hyperplasia and thus stenosis of the vessel.
In some embodiments of the present invention, as shown in fig. 3 and 4, the spring coil further comprises: a developing member 300 disposed in the embolic coil 100, wherein the developing member 300 is at least one of a developing coil and a developing wire. 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.
Optionally, the volume of the development member 300 in the compressed state is less than or equal to half the volume at free relaxation. Considering that the developing member 300 is made of non-degradable material, the developing member 300 can be obviously compressed after the embolic coil 100 is degraded, so that the volume of the aneurysm is obviously reduced, and the occupation is reduced.
Alternatively, the developing member 300 has a bending resistance lower than 50 grams force, thus facilitating the pushing of the spring ring.
Alternatively, both ends of the developing member 300 may be connected to the embolic coil 100 by welding or bonding.
Alternatively, as shown in fig. 3, 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. 3, 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 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, 0.002 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.
Alternatively, the number of developing filaments is 1 to 12 (e.g., 1, 2, 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.
Another embodiment of the present invention provides a method for manufacturing a spring coil, as shown in fig. 5, the method including:
s100, preparing the embolic coil 100 by adopting degradable materials;
step S200, forming a plurality of groove structures 200 on the embolic coil 100.
Compared with a smooth structure, the groove structure 200 of the spring ring prepared by the preparation method can easily induce vascular cell adhesion, the vascular cell adhesion can be realized more quickly, the vascular cell adhesion can be induced immediately after the spring ring is implanted, the embolic coil 100 is driven to actively degrade and be absorbed by a human body after vascular cells grow in the groove structure 200, the degradation is not carried out by simply utilizing the degradation characteristic of an absorbable material to remove inertia, the degradation period of the embolic coil can be greatly shortened, in the degradation process, the occupied space of the spring ring is gradually occupied by endothelial vascular cells, the fibrous tissues in the aneurysm continuously shrink to continuously reduce the aneurysm, the volume of the aneurysm is reduced, and long-term potential safety hazards and occupation effects are eliminated.
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.
For step S200, the step S200 includes: the groove structure 200 is formed on the embolic coil 100 by cutting, etching, heat fusing, or additive manufacturing (i.e., 3D printing).
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 provides a method for manufacturing a spring coil, as shown in fig. 6, the method including:
s100, adopting degradable material to plug core wires;
step S200, forming a plurality of groove structures 200 on the embolic core wire, and then making the embolic core wire into the embolic coil 100.
Compared with a smooth structure, the groove structure 200 of the spring ring prepared by the preparation method can easily induce vascular cell adhesion, the vascular cell adhesion can be realized more quickly, the vascular cell adhesion can be induced immediately after the spring ring is implanted, the embolic coil 100 is driven to actively degrade and be absorbed by a human body after vascular cells grow in the groove structure 200, the degradation is not carried out by simply utilizing the degradation characteristic of an absorbable material to remove inertia, the degradation period of the embolic coil can be greatly shortened, in the degradation process, the occupied space of the spring ring is gradually occupied by endothelial vascular cells, the fibrous tissues in the aneurysm continuously shrink to continuously reduce the aneurysm, the volume of the aneurysm is reduced, and long-term potential safety hazards and occupation effects are eliminated.
With respect to step S200, in some embodiments of the present invention, the groove structure 200 may be formed on the core wire by cutting, etching, heat fusing or additive manufacturing.
Referring to step S200, in other embodiments of the present invention, after the groove structure 200 is formed on the core wire, the core wire is wound on a mandrel to form the embolic coil 100, and then a setting process is performed on a mold according to a predetermined shape.
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.
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 (18)
1. A spring coil, comprising: degradable embolic coil (100), set up in development coil in embolic coil (100) and set up a plurality of induction units on embolic coil (100), induction unit is used for inducing vascular cell to adhere to on embolic coil (100).
2. A spring ring as claimed in claim 1, characterized in that the induction unit is a groove structure (200).
3. A spring coil, comprising: an embolic coil (100) and a plurality of groove structures (200) disposed on the embolic coil (100), wherein the embolic coil (100) is a degradable material.
4. A spring coil as claimed in claim 3, characterized in that the total volume of the groove structure (200) is 0.01-0.1% of the volume of the embolic coil (100).
5. A spring ring according to claim 3, characterized in that the groove structure (200) opens onto the inner and/or outer surface of the embolic coil (100).
6. A spring coil as claimed in claim 3, characterised in that the groove structure (200) is shaped as a shuttle, the length direction of the groove structure (200) being parallel to the axial direction of the embolic coil (100).
7. A spring coil as claimed in claim 6, characterized in that the length of the groove structure (200) is 0.1-1 times the wire diameter D1 of the embolic coil (100), and the width and depth of the groove structure (200) are both 10-600 μm.
8. A spring ring as claimed in claim 3, characterized in that the groove structure (200) comprises: the groove structure group is arranged along the axial direction of the embolic coil (100) at intervals, the groove structure group is distributed along the circumferential direction of the embolic coil (100), and the number of the groove structures of each groove structure group is 10-1000.
9. A spring coil according to any of claims 3-8, wherein a coating is provided in the groove structure (200), the matrix of the coating being a degradable polymer loaded with at least one of a pro-vascular endothelial growth drug, a growth factor, an anti-inflammatory drug, wherein the degradation period of the degradable polymer is less than or equal to the degradation period of the embolic coil (100).
10. The spring coil of claim 9, wherein the degradable polymer is selected from at least one of polylactic acid, L-polylactic acid, polyglycolic acid/polylactic acid copolymer, polycaprolactone, polyacetylglutamic acid, polyorthoester, polydioxanone, polybutylenesuccinate, polyglyceryl sebacate, chitosan, and polyvinyl alcohol.
11. A spring ring as claimed in claim 9, characterized in that the thickness of the coating is smaller than the depth of the groove structure (200).
12. The spring coil of claim 11, wherein the coating has a thickness of 1 μ ι η to 200 μ ι η.
13. A spring coil according to claim 9, characterized in that the total weight of the coating is between 10ug and 2000ug within the range of 1cm to 70cm of the length of the embolic coil (100).
14. The spring coil of any of claims 3-8, 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, a developing wire.
15. A method of making a spring coil, the method comprising:
preparing an embolic coil (100) from a degradable material;
forming a plurality of groove structures (200) on the embolic coil (100).
16. The method of manufacturing according to claim 15, wherein the forming a plurality of groove structures (200) on the embolic coil (100) comprises: forming the groove structure (200) on the embolic coil (100) by cutting, etching, hot melting or additive manufacturing.
17. The production method according to claim 15 or 16, characterized by further comprising: acquiring a visualization (300), disposing the visualization (300) within the embolic coil (100).
18. A method of making a spring coil, the method comprising:
preparing the embolism core wire by adopting degradable materials;
forming a plurality of groove structures (200) on the embolic core wire, followed by forming the embolic core wire into an embolic coil (100).
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