WO2022142787A1 - 一种栓塞物及其制备方法 - Google Patents

一种栓塞物及其制备方法 Download PDF

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Publication number
WO2022142787A1
WO2022142787A1 PCT/CN2021/130762 CN2021130762W WO2022142787A1 WO 2022142787 A1 WO2022142787 A1 WO 2022142787A1 CN 2021130762 W CN2021130762 W CN 2021130762W WO 2022142787 A1 WO2022142787 A1 WO 2022142787A1
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WO
WIPO (PCT)
Prior art keywords
helical
helical member
shaping
wire
curing glue
Prior art date
Application number
PCT/CN2021/130762
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English (en)
French (fr)
Inventor
张朔
杨瑞
蔡亮
钱少君
余画
Original Assignee
神遁医疗科技(上海)有限公司
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Filing date
Publication date
Application filed by 神遁医疗科技(上海)有限公司 filed Critical 神遁医疗科技(上海)有限公司
Priority to KR1020237020269A priority Critical patent/KR20230107857A/ko
Priority to JP2023540682A priority patent/JP2024501723A/ja
Priority to EP21913530.8A priority patent/EP4241699A4/en
Priority to US18/255,485 priority patent/US20240016498A1/en
Publication of WO2022142787A1 publication Critical patent/WO2022142787A1/zh

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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
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • 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
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • 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
    • 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
    • A61B17/12154—Coils or wires having stretch limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the invention relates to the technical field of medical devices, in particular to an intravascular embolus and a preparation method thereof.
  • Intracranial aneurysm refers to the abnormal protrusion of the intracranial artery wall, forming a tumor-like lesion.
  • the survey found that in recent years, the incidence of intracranial aneurysm has increased, and the disease has a high mortality and disability rate. Therefore, improving the cure rate of intracranial aneurysm has become an urgent problem to be solved.
  • the coils are permanently present in the aneurysm cavity, which may cause mass effect and cause compression of peripheral nerves and tissues.
  • the coil is prepared from bioabsorbable materials and implanted into the aneurysm. As the coil degrades and absorbs and is squeezed by the surrounding tissue, the volume of the aneurysm will gradually shrink, thereby reducing the mass effect; and the bioactive material can Accelerating the generation of fibroblasts in the tumor neck to achieve the effect of promoting the regeneration of vascular smooth muscle has received extensive attention.
  • spring coils containing degradable/absorbable materials are still in the conceptual stage, and there are no mature market products.
  • spring coils made of absorbable bioactive materials usually have good X-ray permeability, so that the development effect is poor in the actual pushing operation process, which increases the difficulty of the doctor's operation.
  • a few reports have proposed adding radiopaque components to the degradable coils. The structure of such coils is relatively complex, and the difficulty of connecting and fixing the components is relatively high.
  • the present invention provides an emboli and a preparation method thereof.
  • the visibility of the emboli satisfies the clinical requirements and the supportability and stability in the aneurysm, at least part of the emboli can be gradually degraded and absorbed by the body, It is converted into small molecular substances that are harmless to the body, thereby reducing the effect of occupying space.
  • the present invention provides a plug, comprising a tubular first helical member with an inner cavity, a second helical member nested on the outer side of the first helical member, and at least partially disposed on the first helical member.
  • the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.
  • the first helical member is a metal member made of one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof.
  • the first helical part is a composite material part doped with a developing substance in a matrix, wherein the developing substance is an iodine contrast agent or barium sulfate, and the matrix is polylactic acid, polyglycolic acid, lactic acid- One or more of glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan and hyaluronic acid.
  • the developing substance is an iodine contrast agent or barium sulfate
  • the matrix is polylactic acid, polyglycolic acid, lactic acid- One or more of glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan and hyaluronic acid.
  • the second helical part is polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium , one or more of magnesium alloys, iron and iron alloys.
  • the fixing member is a polymer wire, wherein the polymer wire is polypropylene, nylon, polyester, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone. one or more.
  • the polymer filaments are respectively connected to both ends of the second helical member by physical winding or knotting, so as to fix the first helical member and the second helical member.
  • both ends of the polymer wire are connected to two ends of the first helical part and the second helical part respectively by means of knotting.
  • the polymer filaments respectively knot at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member.
  • the polymer filament is knotted by wrapping at least one helix on the first helical member and at least one helix on the second helical member to retain the first helix
  • the member and the second helical member are coaxial or axially parallel.
  • the first helical part includes a first helical unit and a second helical unit, and the first helical unit and the second helical unit are coaxial or axially parallel.
  • the fixing member is a polymer wire, and the polymer wire passes through the inner cavity of the first helical unit and the second helical unit respectively, wherein the polymer wire passes through Parts of the first helical unit and the second helical unit are connected to the second helical member for fixing the first helical unit, the second helical unit and the second helical member.
  • the fixing member is a curing glue
  • the curing glue is arranged between the first helical member and the second helical member, and at least partially placed in the inner cavity of the first helical member. to fix the first helical part and the second helical part.
  • the fixing member includes a first curing glue and a second curing glue, and the first curing glue and the second curing glue are respectively disposed on two ends of the second spiral member.
  • the fixing component further includes a third curing glue, and the third curing glue is disposed at any position between the first curing glue and the second curing glue.
  • first helical member and the second helical member are coaxial or axially parallel, and/or the axial length of the first helical member is not greater than the axial length of the second helical member .
  • At least one end of the second helical member is formed into a spherical cap by means of hot melting or dispensing to perform end capping, wherein the end of the first helical member is also coated on the spherical cap.
  • At least a portion of the fixing member close to the end of the second screw member is also coated on the ball cap.
  • the plug also includes a shaping member at least partially disposed in the inner cavity of the first helical member, and one end of the shaping member is wrapped around the spherical cap.
  • the shaping member includes at least one shaping wire, wherein the cross section of each shaping wire is circular, oval or polygonal.
  • the material of the shaping part is one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.
  • the shaping member has at least one secondary shaping structure selected from the group consisting of spiral, wave, tetrahedron, pentahedron and hexahedron.
  • the outer diameter of the tubular second helical part is in the range of 0.005-0.05 inches, and the length in the range of 0.5-200 cm, wherein the cross-section of the wire wound around the second helical part is circular or a portion of a circle, the diameter or radius of curvature of the wire is 2 times the size in the range of 0.0005-0.005 inches.
  • the outer diameter of the tubular first helical member is in the range of 0.002-0.02 inches, and the length is 10%-100% of the length of the tubular second helical member, wherein the first helix is wound
  • the cross-section of the wire of the component is a circle or part of a circle, and the diameter or radius of curvature of the wire is 2 times the size in the range of 0.0003-0.003 inches.
  • the present invention also provides an embolism, comprising a tubular first helical member having an inner cavity, a second helical member wound around the outer side of the first helical member, and at least partially disposed on the first helical member.
  • a shaping member within the lumen of a helical member and a fixation member disposed at least partially within the lumen of the first helical member wherein: the first helical member comprises a radiopaque material and the second helical member comprises a bioavailable Absorbing material; the fixing part is connected to both ends of the second helical part by physical winding or knotting; one end of the shaping part is fixed to one end of the first helical part and the second helical part; And at least one end of the second helical part is sealed by forming a spherical cap by means of hot melting or dispensing, and at least part of the first helical part and the shaping part are wrapped around the spherical cap.
  • the present invention also provides a method for preparing emboli, which includes the following steps: pre-forming the wound first helical part on a mold according to a preset shape; setting the fixed part in the inner cavity of the first helical member; and sleeve the wound second helical member on the outside of the wound first helical member.
  • the preparation method further includes: pre-forming the wound shaped part on a mold according to a preset shape; and arranging the pre-shaped shaping part on the pre-shaped first part.
  • the fixing member disposed in the inner cavity of the first helical member is respectively connected to the first helical member and the second helical member by means of physical winding or knotting. two ends; and one end of the shaping member, one end of the first screw member and one end of the second screw member are fixed together.
  • the way of tying the polymer wire with the first helical part and the second helical part is that the polymer wire is first oriented to at least one of the first helical parts of the inner ring. After the loop is helically knotted, at least one loop of the second helical part of the outer loop is then knotted.
  • the way of tying the polymer wire with the first helical part and the second helical part is that the polymer wire simultaneously ties at least one turn of the helical and the second helical part on the first helical part. At least one turn of the helix on the second helical part is knotted to keep the first helical part and the second helical part coaxial or axially parallel.
  • emboli provided by the present invention and the preparation method thereof have the following advantages:
  • the above-mentioned emboli adopts a double-layer structure of bioabsorbable material and metal opaque material, so that the emboli maintains the good development and support characteristics of traditional metal coils, while the bioabsorbable material is partially It can be partially degraded and absorbed within a certain period of time, which can effectively alleviate the problems of large aneurysms, such as the mass effect that may cause compression of surrounding tissues and nerves.
  • the above-mentioned double-layer helical structure of the emboli is designed with reasonable connection and fixation between different components, keeping the basic coaxial or axial parallel of the double-layer structure, which effectively improves the doctor's maneuverability in the process of using the emboli. sex.
  • FIG. 1 is a partial cross-sectional view of an embolus according to a first embodiment of the present invention
  • Figure 2 is a cross-sectional view of the embolic device shown in Figure 1;
  • Fig. 3 is the sectional view of the embolism of the second embodiment of the present invention.
  • Fig. 4 is the sectional view of the embolism of the third embodiment of the present invention.
  • Fig. 5 is the sectional view of the embolism of the fourth embodiment of the present invention.
  • Fig. 6 is a cross-sectional view of an embolus according to a fifth embodiment of the present invention.
  • 10-plug 100-first helical part; 102-first helical unit; 104-second helical unit; 106-third helical unit; 110-lumen; 120-second helical part; 130-setting part; 132-distal end of shaping member; 134-proximal end of shaping member; 140-distal end; 150-ball cap; 160-proximal end; Parts of the helical unit and the second helical unit; 172 - the first curing glue; 174 - the second curing glue; 176 - the third curing glue; 177 - the distal end of the fixed part; 179 - the proximal end of the fixed part.
  • distal end and proximal end are used; “proximal end” is the end close to the medical device operator; “distal end” is the end away from the medical device operator.
  • distal end is the end close to the medical device operator; “distal end” is the end away from the medical device operator.
  • the core idea of the present invention is to provide a plug, comprising a tubular first helical member with an inner cavity, a second helical member nested on the outer side of the first helical member, and at least partially disposed in the first helical member A fixing member in the inner cavity of the member, wherein the first helical member comprises a radiopaque material, the second helical member comprises a bioabsorbable material, and both ends of the fixing member are respectively connected to the second helical member Both ends of the , used to fix the first helical part and the second helical part.
  • the present invention also provides an embolism, comprising a tubular first helical member having an inner cavity, a second helical member wound around the outer side of the first helical member, and at least partially disposed on the first helical member.
  • a shaping member within the lumen of a helical member and a fixation member disposed at least partially within the lumen of the first helical member wherein: the first helical member comprises a radiopaque material and the second helical member comprises a bioavailable Absorbing material; the fixing part is connected to both ends of the second helical part by physical winding or knotting; one end of the shaping part is fixed to one end of the first helical part and the second helical part; And at least one end of the second helical part is formed into a spherical cap by means of hot-melting or gluing for end capping, and at least part of the first helical part and the shaping part covers the spherical cap.
  • the embolus in the present application can be a coil applied to the treatment of intracranial vascular diseases, which is used to treat vascular diseases such as intracranial aneurysms.
  • the vascular implant can also be applied to the treatment of non-intracranial vascular aneurysms and other diseases.
  • the biological material in the double-layer structure can be gradually degraded and absorbed by the body, and converted into small molecular substances that are harmless to the body, thereby reducing the effect of occupying space.
  • fixed parts are set in the double-layer helical structure, and reasonable connection and fixation are designed between different parts, so that the fixed parts and the double-layer structure are basically coaxial or axially parallel, which effectively improves the process of using emboli for doctors. operability in.
  • FIG. 1 is a partial cross-sectional view of an embolic device 10 according to a first embodiment of the present invention.
  • FIG. 2 is a cross-sectional view of the plug 10 shown in FIG. 1 .
  • the emboli 10 is an elongated device of greater length extending from its proximal end 160 to its distal end 140 .
  • the proximal end 160 of the emboli 10 is configured to connect with a pusher (not shown) of the emboli 10 .
  • the plug 10 includes a tubular first helical member 100 having an inner lumen 110, a second helical member 120 nested on the outer side of the first helical member 100, and a second helical member 120 disposed at least partially within the lumen 110 of the first helical member 100.
  • Fixed part 170 wherein, the first helical part 100 , the second helical part 120 and the shaping part 170 are substantially coaxial or axially parallel. Two ends of the fixing member 170 are respectively connected to two ends of the second helical member 120 for fixing the first helical member 100 and the second helical member 120 .
  • the first helical member 100 includes a radiopaque material.
  • the first helical member 100 is a metal member made of one of platinum, iridium, gold, silver, tantalum and tungsten or an alloy thereof, and the metal wire made of the above-mentioned materials is in a core of a predetermined diameter.
  • the first helical member 100 is formed by helical winding on the column.
  • the pitch of the coil of the first helical part 100 may be uniform, may also be gradually changed along the length of the coil, and may also have different pitches in different sections of the coil.
  • the first helical part 100 is a composite material part with a matrix doped with a developing substance, wherein the developing substance can be an iodine contrast agent or barium sulfate, and the matrix can be polylactic acid, polyglycolic acid, lactic acid-hydroxyl One or more of acetic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan and hyaluronic acid.
  • the first helical part 100 is formed by helically winding a filamentary composite material part on a stem of predetermined diameter.
  • the second helical member 120 includes a bioabsorbable material, which may be polylactic acid, polyglycolic acid, lactic acid-co-glycolic acid, polydioxanone, polycaprolactone One or more of ester, polyurethane, chitosan, hyaluronic acid, magnesium, magnesium alloy, iron and iron alloy.
  • the above-mentioned second helical part 120 can also be modified, for example, some active substances, which may be growth factors or certain drug molecules, are loaded inside or on the surface of the second helical part 120 .
  • the second helical part 120 is formed by helically winding a polymer or metal wire made of the above-mentioned materials on a core column with a predetermined diameter. It can be understood that the pitch of the coils of the second helical part 120 may be uniform, may also be gradual along the length of the coil, and may also have different pitches in different sections of the coil.
  • the volume of the second helical member 120 made of bioabsorbable material ranges from 30-90% of the total volume of the entire emboli 10 .
  • the emboli 10 using the double-layer structure of bioabsorbable material and metal opaque material maintains the better developing and supporting characteristics of traditional metal coils, and the bioabsorbable material part can be used within a certain period of time. It is partially degraded and absorbed, which can effectively alleviate problems such as mass effect that may cause compression of surrounding tissues and nerves for large aneurysms.
  • the outer diameter of the first helical member 100 is in the range of 0.002-0.02 inches
  • the cross-section of the wire wound around the first helical member 100 is a circle or a portion of a circle
  • the diameter or curvature of the wire is The size range of 2 times the radius is 0.0003-0.003 inches.
  • the outer diameter of the second helical member 120 is in the range of 0.005-0.05 inches
  • the cross-section of the wire wound around the second helical member 120 is a circle or part of a circle, and the diameter of the wire is twice the size of the radius of curvature The range is 0.0005-0.005 inches.
  • the second helical part 120 is wrapped outside the first helical part 100 , and the axial length of the first helical part 100 is not greater than the axial length of the second helical part 120 .
  • the length of the second helical part 120 is in the range of 0.5-200 cm.
  • the length of the first helical part 100 is slightly shorter than the length of the second helical part 120, which is 10% of the length of the tubular structure wound by the second helical part 120- 100%.
  • the fixing member 170 can be a polymer wire, and the material of the polymer wire is polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polyhexamethylene One or more of the lactones.
  • the polymer wire is connected to both ends of the first helical part 100 and the second helical part 120 by physical winding or knotting, respectively, so as to fix the first helical part 100 and the second helical part 120 .
  • the fixing member 170 is knotted with the first helical member 100 and the second helical member 120 in a manner that the fixing member 170 simultaneously ties at least one turn of the helix on the first helical member 100 and the second helix on the second helical member 120 . At least one turn of the helix is knotted to keep the first helical member 100 and the second helical member 120 substantially coaxial or axially parallel. It can be 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 that shown in FIG. 2 , and the fixing member 170 can be knotted at any position on the circumference of the helical member.
  • the fixing member 170 is knotted with the first helical member 100 and the second helical member 120 in a manner that the fixing member 170 firstly ties at least one turn of the helix on the first helical member 100 of the inner ring, and then Then at least one turn of the helix on the second helical part 120 of the outer ring is knotted.
  • the knotting manner of the fixing member 170 and the first helical member 100 and the second helical member 120 may also be: at both ends of the first helical member 100 and the second helical member 120, the fixing member 170 is only At least one turn of the helix on the first helical part 100 or at least one turn of the helix on the second helical part 120 is knotted.
  • an atraumatic distal tip is formed on the distal ends 140 of the first helical member 100 and the second helical member 120 by means of thermal fusion or dispensing, and the distal end 177 of the fixing member 170 is attached to the first helical member 170 .
  • the member 100 and at least a portion of the distal end 140 of the second helical member 120 are firmly bonded to each other.
  • the atraumatic distal tip can be the spherical cap 150 shown in FIG. 2 , or it can be a conical or oval closed end, at least part of the distal ends 140 of the first helical member 100 and the second helical member 120 are Covered in the ball cap 150 .
  • the atraumatic distal tip may be formed from a polymeric material such as polyester, acrylic adhesive, or other polymeric material suitable for hot melt or dispensing.
  • at least a portion of the securing member 170 knotted on the second helical member 120 is also encapsulated in the ball cap 150 .
  • the proximal ends 160 of the first helical member 100 and the second helical member 120 can also be formed into atraumatic distal tips by hot melting or dispensing, and the proximal ends 179 of the fixing member 170 can be connected with At least portions of the proximal ends 160 of the first helical member 100 and/or the second helical member 120 are firmly bonded to each other.
  • FIG. 3 is a cross-sectional view of an embolic device 10 according to a second embodiment of the present invention.
  • the plug 10 includes a tubular first helical member 100 having an inner lumen 110, a second helical member 120 nested on the outer side of the first helical member 100, and a second helical member 120 disposed at least partially within the lumen 110 of the first helical member 100.
  • Fixed part 170 .
  • the first helical component 100 includes a first helical unit 102 and a second helical unit 104 that are substantially coaxial or axially parallel.
  • the fixing member 170 is a polymer wire, and the polymer wire passes through the lumen of the first helical unit 102 and the second helical unit 104, respectively, wherein the polymer wire passes through the first helical unit 102
  • the parts 171 , 173 and 175 of the second helical unit 104 are respectively connected to the corresponding positions of the second helical part 120 for fixing the first and second helical units 102 , 104 and the second helical part 120 .
  • the first helical member 100 may have 3, 4, 5 or more helical units.
  • FIG. 4 is a cross-sectional view of an embolic device 10 according to a third embodiment of the present invention.
  • the plug 10 includes a tubular first helical member 100 having an inner lumen 110, a second helical member 120 nested on the outer side of the first helical member 100, and a second helical member 120 disposed at least partially within the lumen 110 of the first helical member 100.
  • Fixed part 170 Fixed part 170 .
  • the fixing member 170 includes a first curing glue 172 and a second curing glue 174, which are disposed between the first helical member 100 and the second helical member 120, and are at least partially placed in the inner cavity 110 of the first helical member for use in The first helical member 100 and the second helical member are fixed.
  • the first curing glue 172 and the second curing glue 174 are respectively disposed on two ends of the second helical member 120 to cover at least part of the two ends of the first helical member 100 , used to fix the first helical member 100 to the second helical member 120 .
  • the first curing glue 172 and the second curing glue 174 are formed by dispensing glue outside the second spiral part 120
  • the first curing glue 172 can be formed by dispensing glue around the second spiral part 120 once. It can also be formed by dispensing glue at at least one point outside the second spiral component 120 .
  • the fixing member further includes a third curing glue
  • the third curing glue can be disposed at any position between the first curing glue 172 and the second curing glue 174 and is respectively coupled to the first screw member 100 and the second helical member 120 for fixing the first helical member 100 to the second helical member 120 .
  • FIG. 5 is a cross-sectional view of an embolic device 10 according to a fourth embodiment of the present invention.
  • the first helical member 100 includes a first helical unit 102 , a second helical unit 104 and a third helical unit 106 that are substantially coaxial or axially parallel.
  • the fixing member 170 may include a first curing glue 172 , a second curing glue 174 and a third curing glue 176 , and the first curing glue 172 and the second curing glue 174 are respectively disposed on two ends of the second spiral member 120 .
  • the third curing glue 176 is disposed between the second helical member 120 and the third helical unit 106 for fixing the third helical unit 106 to the second helical member 120 .
  • the number of helical units and curing glue is not limited thereto.
  • FIG. 6 is a cross-sectional view of an embolic device 10 according to a fifth embodiment of the present invention.
  • the plug 10 includes a tubular first helical member 100 having an inner lumen 110 , a second helical member 120 nested on the outer side of the first helical member 100 , and a second helical member 120 disposed at least partially in the lumen 110 of the first helical member 100 .
  • the shaping part 130 and the fixing part 170 at least partially placed in the inner cavity 110 of the first helical part 100 .
  • the structures and usage of the first helical member 100 , the second helical member 120 and the fixing member 170 are substantially the same as those in the embodiment shown in FIG. 2 , and the description is not repeated here.
  • the shaping member 130 and the first helical member 100 are substantially coaxial or axially parallel.
  • the distal end 132 of the shaping member 130 is fixed to the distal ends 140 of the first helical member 100 and the second helical member 120 , and the proximal end 134 of the shaping member 130 is a free end, which is provided on the first helical member 100 . in the proximal lumen 110 .
  • the distal end 132 of the shaping member 130 is provided as an inverted J-shaped hook, which is connected with at least one coil of the distal end 140 of the first helical member 100, such as the last coil, and then is heated by melting or spotting
  • An atraumatic distal tip is formed on the distal ends 140 of the first helical member 100 and the second helical member 120 by means of glue, and the distal end 132 of the shaping member 130 is attached to the distal end of the first helical member 100 and the second helical member 120.
  • the ends 140 are firmly joined to each other, ie, at least a portion of the inverted J-shaped hook and the distal ends 140 of the first and second helical members 100, 120 are wrapped around the atraumatic distal tip.
  • the atraumatic distal tip can be the spherical cap 150 shown in Figure 2, or it can be a conical or oval closed end.
  • the atraumatic distal tip may be formed from a polymeric material such as polyester, acrylic adhesive, or other polymeric material suitable for hot melt or dispensing.
  • the distal end 132 of the shaping member 130 can also be connected to the distal end 140 of the first helical member 100 and the second helical member 120 by other means, such as straight, inverted J, or other shapes
  • the distal end 132 of the shaping member 130 is directly wrapped and fixed by the ball cap 150; or the distal end 132 of the shaping member 130 is first connected to at least one coil of the second helical member 120 and then wrapped and fixed by the ball cap 150;
  • the shaping part 130 is connected to at least one end of the first helical part 100 and the second helical part 120 in a knotted manner.
  • the proximal end 134 of the shaping member 130 is connected to the proximal end 160 of the first helical member 100, and the distal end 132 is the free end.
  • the proximal end 134 and the distal end 132 may also be connected to the proximal end 160 and the distal end 140 of the first helical member 100, respectively.
  • the shaping member 130 includes at least one shaping wire, wherein the cross-section of each shaping wire is circular, oval or polygonal, and its diameter does not exceed 90% of the inner diameter of the first helical member 100, wherein The inner diameter of the first helical member is in the range of 0.001-0.01 inches.
  • the material for forming the shaping part 130 is memory alloy, which can be one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.
  • the shaping member 130 made of the above-mentioned materials not only enhances the visibility of the double-layer helical structure in blood vessels and aneurysms, but also can perform three-dimensional pre-sizing of the memory alloy, which is used to improve the stability of the emboli 10 and make it in the artery.
  • the tumor can have better support.
  • the shaping member 130 may be pre-shaped to have at least one secondary structure of helical, wavy, tetrahedral, pentahedral, and hexahedral.
  • the present invention also provides a method for preparing an emboli 10, with reference to FIG. 6, which mainly includes the following steps:
  • the wound first spiral part 100 and the shaping part 130 are respectively pre-shaped on the mold according to the preset shape, wherein the preset shape can be helical, wavy At least one of , tetrahedron, pentahedron and hexahedron, the preset shapes of the first helical part 100 and the shaping part 130 are also corresponding to each other.

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Abstract

一种栓塞物（10）及其制备方法，栓塞物（10）包括具有内腔（110）的管状的第一螺旋部件（100）、嵌套在第一螺旋部件（100）外侧面的第二螺旋部件（120）和至少部分置于第一螺旋部件（100）内腔（110）中的固定部件（170），其中，第一螺旋部件（100）包括不透射线材料，第二螺旋部件（120）包括生物可吸收材料，固定部件（170）的两端分别连接于第二螺旋部件（120）的两端，用以固定第一螺旋部件（100）和第二螺旋部件（120）。该双层结构的栓塞物（10）中设置了固定部件（170），使栓塞物（10）不仅具有可降解缓解占位效应的性能，还使其在动脉瘤内具有较好的结构稳定性。

Description

一种栓塞物及其制备方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种血管内栓塞物及其制备方法。
背景技术
颅内动脉瘤是指颅内动脉血管壁异常突起，形成瘤状病变。调查发现，近年来，颅内动脉瘤的发病率有增高的趋势，且该病的致死、致残率较高，故提高颅内动脉瘤的治愈率就成了急需解决的问题。
随着影像学和材料学的发展，相对于外科手术，利用弹簧圈栓塞颅内动脉瘤，因其创伤小、风险小并发症少等优点获得了人们越来越多的关注和重视。目前，用于介入治疗的弹簧圈多为金属材质，填入瘤腔后，可以有效的改变血流方向，减轻动脉瘤壁受到的压力；同时可以诱导血栓形成，并促进瘤颈处的内皮化，实现颅内动脉瘤的治疗。
然而对于大或巨大动脉瘤，传统金属弹簧圈栓塞动脉瘤仍然存在一定的局限性：弹簧圈在瘤腔内永久存在，可能会产生占位效应，引起对周围神经和组织的压迫等。利用生物可吸收材料制备弹簧圈，将其植入到动脉瘤中，随着弹簧圈的降解吸收，受到周围组织挤压，动脉瘤体积会逐渐收缩，从而降低占位效应；并且生物活性材料可以加速瘤颈处生成纤维细胞，达到促进血管平滑肌再生的效果，受到了广泛的关注。
目前，含可降解/可吸收材料的弹簧圈仍处于概念阶段，还没有成熟的上市产品。根据调研，可吸收的生物活性材料制成的弹簧圈通常X射线透过性好，以至于在实际的推送操作过程中显影效果较差,增加了医生手术操作难度。另外，少数报道提出了在可降解弹簧圈中添加不透射线部件，这种弹簧圈结构的结构相对复杂，各部件之间连接和固定的难度也相对较高。
因此，需要一种新的栓塞物，来解决至少上述问题。
发明内容
本发明提供了一种栓塞物及其制备方法，该栓塞物在可视性满足临床需求和其在动脉瘤中支撑性和稳定性的前提下，至少部分栓塞物可以逐渐被机体降解和吸收，转化成对机体无害的小分子物质，从而起到降低占位效应的效果。
为实现上述目的，本发明提供了一种栓塞物，包括具有内腔的管状的第一螺旋部件、嵌套在所述第一螺旋部件外侧面的第二螺旋部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其中，所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料，所述固定部件的两端分别连接于所述第二螺旋部件的两端，用以固定所述第一螺旋部件和所述第二螺旋部件。
可选地，所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料。
可选地，所述第一螺旋部件为铂、铱、金、银、钽和钨中的一种或其合金制成的金属部件。
可选地，所述第一螺旋部件为基体中掺杂了显影物质的复合材料部件，其中，所述显影物质为碘造影剂或硫酸钡，所述基体为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖和透明质酸中的一种或几种。
可选地，所述第二螺旋部件为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖、透明质酸、镁、镁合金、铁和铁合金中的一种或几种。
可选地，所述固定部件为聚合物丝材，其中所述聚合物丝材为聚丙烯、尼龙、聚酯、聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚己内酯中的一种或几种。
可选地，所述聚合物丝材通过物理缠绕或打结的方式分别连接于所述第二螺旋部件的两端，用以固定所述第一螺旋部件和所述第二螺旋部件。
可选地，所述聚合物丝材的两端通过打结的方式分别连接于所述第一螺旋部件和所述第二螺旋部件的两端。
可选地，所述聚合物丝材对所述第一螺旋部件上的至少一圈螺旋和对所述第二螺旋部件上的至少一圈螺旋分别进行打结。
可选地，所述聚合物丝材将所述第一螺旋部件上的至少一圈螺旋和所述第二螺旋部件上的至少一圈螺旋缠绕在一起进行打结，以保持所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行。
可选地，所述第一螺旋部件包括第一螺旋单元和第二螺旋单元，所述第一螺旋单元和所述第二螺旋单元同轴或轴向平行。
可选地，所述固定部件为聚合物丝材，所述聚合物丝材分别穿过所述第一螺旋单元和所述第二螺旋单元的内腔，其中，所述聚合物丝材穿出所述第一螺旋单元和所述第二螺旋单元的部分连接于所述第二螺旋部件，用以固定所述第一螺旋单元、第二螺旋单元和所述第二螺旋部件。
可选地，所述固定部件为固化胶，所述固化胶设置于所述第一螺旋部件和所述第二螺旋部件之间，且至少部分置于所述第一螺旋部件内腔中，用以固定所述第一螺旋部件和所述第二螺旋部件。
可选地，所述固定部件包括第一固化胶和第二固化胶，所述第一固化胶和第二固化胶分别设置于所述第二螺旋部件的两个端部。
可选地，所述固定部件还包括第三固化胶，所述第三固化胶设置于所述第一固化胶和第二固化胶之间的任意位置。
可选地，所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行，和/或，所述第一螺旋部件的轴向长度不大于所述第二螺旋部件的轴向长度。
可选地，所述第二螺旋部件的至少一端通过热熔或点胶的方式形成球帽以进行封端，其中，所述第一螺旋部件的端部也被包覆于所述球帽。
可选地，所述固定部件靠近所述第二螺旋部件端部的至少部分也被包覆于所述球帽。
可选地，所述栓塞物还包括至少部分置于所述第一螺旋部件内腔中的定型部件，所述定型部件的一端被包覆于所述球帽。
可选地，所述定型部件包括至少一根定型丝材，其中每根所述定型丝材的截面为圆形、椭圆形或多边形。
可选地，所述定型部件的材料为钴铬合金、镍钛合金和铂钨合金中的一种或几种。
可选地，所述定型部件具有螺旋形、波浪形、四面体、五面体和六面体中的至少一种二级定型结构。
可选地，管状的所述第二螺旋部件的外径尺寸范围为0.005-0.05英寸，长度尺寸范围为0.5-200厘米，其中，绕制所述第二螺旋部件的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍尺寸范围为0.0005-0.005英寸。
可选地，管状的所述第一螺旋部件的外径尺寸范围为0.002-0.02英寸，长度为管状的所述第二螺旋部件长度的10％-100％，其中，绕制所述第一螺旋部件的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍尺寸范围为0.0003-0.003英寸。
为实现上述目的，本发明还提供了一种栓塞物，包括具有内腔的管状的第一螺旋部件、缠绕于所述第一螺旋部件外侧面的第二螺旋部件、至少部分置于所述第一螺旋部件内腔中的定型部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其中：所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料；所述固定部件通过物理缠绕或打结的方式分别连接于所述第二螺旋部件的两端；所述定型部件的一端固定于所述第一螺旋部件及第二螺旋部件的一端；以及所述第二螺旋部件的至少一端通过热熔或点胶的方式形成球帽进行封端，所述第一螺旋部件和所述定型部件的至少部分包覆于所述球帽。
为实现上述目的，本发明还提供了一种的栓塞物制备方法，其中，包括下列步骤：将绕制好的第一螺旋部件按照预设的形状在模具上进行预定型处理；将固定部件设置于所述第一螺旋部件的内腔中；以及将绕制好的第二螺旋部件套设于绕制好的所述第一螺旋部件外侧。
可选的，所述制备方法还包括，将绕制好的定型部件按照预设的形状在模具上进行预定型处理；将预定型好的所述定型部件设置于预定型好的所述第一螺旋部件的内腔中；将设置于所述第一螺旋部件的内腔中的所述固定部 件通过物理缠绕或打结的方式分别连接于所述第一螺旋部件和所述第二螺旋部件的两端；以及将所述定型部件的一端与所述第一旋部件及第二螺旋部件的一端固定在一起。
可选地，所述聚合物丝材与所述第一螺旋部件和所述第二螺旋部件的打结方式为所述聚合物丝材先对内圈的所述第一螺旋部件上的至少一圈螺旋打结后，再对外圈的所述第二螺旋部件上的至少一圈螺旋打结。
可选地，所述聚合物丝材与所述第一螺旋部件和所述第二螺旋部件的打结方式为所述聚合物丝材同时对所述第一螺旋部件上的至少一圈螺旋和所述第二螺旋部件上的至少一圈螺旋打结，以保持所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行。
综上，本发明提供的栓塞物以及其制备方法具有如下优点：
第一、上述栓塞物采用生物可吸收材料和金属不透射材料的双层结构，使栓塞物在保持了传统的金属弹簧圈较好的显影性和支撑性等特征的同时，生物可吸收材料部分可以在一定时间内被部分降解和吸收，能够有效缓解对于大型动脉瘤可能引起压迫周围组织和神经的占位效应等问题。
第二、上述栓塞物的双层螺旋结构在不同部件之间设计了合理的连接和固定，保持双层结构基本的同轴或轴向平行，有效提高了医生在使用栓塞物过程中的可操作性。
附图说明
图1是本发明第一实施例的栓塞物的局部剖视图；
图2是图1所示的栓塞物的剖视图；
图3是本发明第二实施例的栓塞物的剖视图；
图4是本发明第三实施例的栓塞物的剖视图；
图5是本发明第四实施例的栓塞物的剖视图；
图6是本发明第五实施例的栓塞物的剖视图。
图中：
10-栓塞物；100-第一螺旋部件；102-第一螺旋单元；104-第二螺旋单 元；106-第三螺旋单元；110-内腔；120-第二螺旋部件；130-定型部件；132-定型部件的远端；134-定型部件的近端；140-远端；150-球帽；160-近端；170-固定部件；171、173、175-聚合物丝材穿出第一螺旋单元和第二螺旋单元的部分；172-第一固化胶；174-第二固化胶；176-第三固化胶；177-固定部件的远端；179-固定部件的近端。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
此外，在以下说明中，为了便于描述，使用了“远端”和“近端”；“近端”是接近医疗器械操作者的一端；“远端”是远离医疗器械操作者的一端。另外，在下文的描述中，给出了大量具体的细节以便提供对本发明更为彻底的理解。然而，对于本领域技术人员而言显而易见的是，本发明可以无需一个或多个这些细节而得以实施。在其他的例子中，为了避免与本发明发生混淆，对于本领域公知的一些技术特征未进行描述。
本发明的核心思想在于提供一种栓塞物，包括具有内腔的管状的第一螺旋部件、嵌套在所述第一螺旋部件外侧面的第二螺旋部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其中，所述第一螺旋部件包括不透射线 材料，所述第二螺旋部件包括生物可吸收材料，所述固定部件的两端分别连接于所述第二螺旋部件的两端，用以固定所述第一螺旋部件和所述第二螺旋部件。
为实现上述目的，本发明还提供了一种栓塞物，包括具有内腔的管状的第一螺旋部件、缠绕于所述第一螺旋部件外侧面的第二螺旋部件、至少部分置于所述第一螺旋部件内腔中的定型部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其中：所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料；所述固定部件通过物理缠绕或打结的方式分别连接于所述第二螺旋部件的两端；所述定型部件的一端固定于所述第一螺旋部件及第二螺旋部件的一端；以及所述第二螺旋部件的至少一端通过热熔或点胶的方式形成球帽以进行封端，所述第一螺旋部件和所述定型部件的至少部分包覆于所述球帽。
可以理解的是，本申请中的栓塞物，可以是一种应用于颅内血管疾病治疗的弹簧圈，用于治疗颅内动脉瘤等血管疾病。另外，该血管植入物也可以应用于非颅内的血管动脉瘤等疾病的治疗。
该栓塞物在植入病灶一段时间后，双层结构中的生物材料可逐渐被机体降解和吸收，转化成对机体无害的小分子物质，从而起到降低占位效应的效果。此外，双层螺旋结构中设置了固定部件，且在不同部件之间设计了合理的连接和固定，使得固定部件和双层结构基本同轴或轴向平行，有效提高了医生在使用栓塞物过程中的可操作性。
以下结合附图和若干实施例对本发明提出的栓塞物及其制备方法作进一步的说明。
图1是本发明第一实施例的栓塞物10的局部剖视图。图2是图1所示的栓塞物10的剖视图。如图所示栓塞物10处于其线性初级形状，栓塞物10为从其近端160延伸至其远端140的长度较大的细长装置。栓塞物10的近端160被设置与该栓塞物10的推送装置(未示出)连接。栓塞物10包括具有内腔110的管状的第一螺旋部件100、嵌套于第一螺旋部件100外侧面的第二螺旋部件120和至少部分置于所述第一螺旋部件100内腔110中的固定部件170。 其中，第一螺旋部件100、第二螺旋部件120和定型部件170基本同轴或轴向平行。固定部件170的两端分别连接于第二螺旋部件120的两端，用以固定第一螺旋部件100和第二螺旋部件120。
其中，第一螺旋部件100包括不透射线材料。在一些实施方式中，第一螺旋部件100为铂、铱、金、银、钽和钨中的一种或其合金制成的金属部件，由上述材料制成的金属丝在预设直径的芯柱上螺旋绕制成第一螺旋部件100。其中，该第一螺旋部件100的线圈的节距可以是均匀的，也可以沿着线圈的长度而渐变，还可以在线圈的不同区段具有不同的节距。
在一些实施方式中，第一螺旋部件100为基体中掺杂了显影物质的复合材料部件，其中，显影物质可以为碘造影剂或硫酸钡，基体可以为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖和透明质酸中的一种或几种。丝状的复合材料部件在预设直径的芯柱上螺旋绕制成该第一螺旋部件100。
在一些实施方式中，第二螺旋部件120包括生物可吸收材料，该生物可吸收材料可以为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖、透明质酸、镁、镁合金、铁和铁合金中的一种或几种。在一些实施方式中，也可以对上述第二螺旋部件120进行改性，例如在该第二螺旋部件120内部或表面负载一些活性物质，可以是生长因子或者某种药物分子等。由上述材料制成的聚合物或者金属丝材在预设直径的芯柱上螺旋绕制成该第二螺旋部件120。可以理解的是，该第二螺旋部件120的线圈的节距可以是均匀的，也可以沿着线圈的长度而渐变，还可以在线圈的不同区段具有不同的节距。
使用生物可吸收材料制成的第二螺旋部件120的体积占整个栓塞物10总体积的百分比范围为30-90％。采用生物可吸收材料和金属不透射材料的双层结构的栓塞物10，在保持了传统的金属弹簧圈较好的显影性和支撑性等特征的同时，生物可吸收材料部分可以在一定时间内被部分降解和吸收，能够有效缓解对于大型动脉瘤可能引起压迫周围组织和神经的占位效应等问题。
在一些实施方式中，第一螺旋部件100的外径尺寸范围为0.002-0.02英寸，绕制第一螺旋部件100的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍的尺寸范围为0.0003-0.003英寸。第二螺旋部件120的外径尺寸范围为0.005-0.05英寸，绕制第二螺旋部件120的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍的尺寸范围为0.0005-0.005英寸。继续参考图1和图2，第二螺旋部件120包覆在第一螺旋部件100外侧，第一螺旋部件100的轴向长度不大于第二螺旋部件120的轴向长度。第二螺旋部件120的长度尺寸范围为0.5-200厘米，第一螺旋部件100长度比第二螺旋部件120的长度略短，为第二螺旋部件120绕制成的管状结构的长度的10％-100％。
如图2所示，固定部件170可以为聚合物丝材，制成该聚合物丝材的材料为聚丙烯、聚酯、尼龙、聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚己内酯中的一种或几种。该聚合物丝材通过物理缠绕或打结的方式分别连接于第一螺旋部件100和第二螺旋部件120的两端，用以固定第一螺旋部件100和第二螺旋部件120。
在一些实施方式中，固定部件170与第一螺旋部件100和第二螺旋部件120的打结方式为固定部件170同时对第一螺旋部件100上的至少一圈螺旋和第二螺旋部件120上的至少一圈螺旋打结，以保持第一螺旋部件100和第二螺旋部件120基本同轴或轴向平行。可以理解的是，固定部件170与第一螺旋部件100和/或第二螺旋部件120的连接位置不局限于图2所示，固定部件170可以在螺旋部件圆周上的任意位置进行打结。在其他一些实施方式中，固定部件170与第一螺旋部件100和第二螺旋部件120的打结方式为固定部件170先对内圈的第一螺旋部件100上的至少一圈螺旋打结后，再对外圈的第二螺旋部件120上的至少一圈螺旋打结。
在一些实施方式中，固定部件170与第一螺旋部件100和第二螺旋部件120的打结方式也可以为：在第一螺旋部件100和第二螺旋部件120的两端，固定部件170分别仅对第一螺旋部件100上的至少一圈螺旋或第二螺旋部件120上的至少一圈螺旋打结。
继续参考图2，在第一螺旋部件100和第二螺旋部件120的远端140通过热熔或点胶的方式形成无创伤性的远侧尖端，将固定部件170的远端177与第一螺旋部件100和第二螺旋部件120的远端140的至少部分彼此牢固地结合在一起。该无创伤性的远侧尖端可以为图2所示的球帽150，也可以为圆锥形或椭圆形的封闭端，第一螺旋部件100和第二螺旋部件120的远端140的至少部分被包覆于球帽150中。其中，该无创伤性的远侧尖端可由聚合物材料形成，例如聚酯、丙烯酸胶黏剂或其他适用于热熔或点胶的聚合物材料。在一些实施方式中，固定部件170在第二螺旋部件120上打结的至少部分也被包覆于球帽150中。在其他一些实施方式中，第一螺旋部件100和第二螺旋部件120的近端160也可以通过热熔或点胶的方式形成无创伤性的远侧尖端，将固定部件170的近端179与第一螺旋部件100和/或第二螺旋部件120的近端160的至少部分彼此牢固地结合在一起。
图3是本发明第二实施例的栓塞物10的剖视图。栓塞物10包括具有内腔110的管状的第一螺旋部件100、嵌套于第一螺旋部件100外侧面的第二螺旋部件120和至少部分置于所述第一螺旋部件100内腔110中的固定部件170。其中，第一螺旋部件100包括基本同轴或轴向平行的第一螺旋单元102和第二螺旋单元104。在一些实施方式中，固定部件170为聚合物丝材，聚合物丝材分别穿过第一螺旋单元102和第二螺旋单元104的内腔，其中，聚合物丝材穿出第一螺旋单元102和第二螺旋单元104的部分171、173和175分别连接于第二螺旋部件120的相对应的位置，用以固定第一螺旋单元及第二螺旋单元102、104和第二螺旋部件120。可以理解的是，第一螺旋部件100可以具有3个、4个、5个或更多个螺旋单元。
图4是本发明第三实施例的栓塞物10的剖视图。栓塞物10包括具有内腔110的管状的第一螺旋部件100、嵌套于第一螺旋部件100外侧面的第二螺旋部件120和至少部分置于所述第一螺旋部件100内腔110中的固定部件170。其中，固定部件170包括第一固化胶172和第二固化胶174，设置于第一螺旋部件100和第二螺旋部件120之间，且至少部分置于第一螺旋部件内腔110中，用以固定第一螺旋部件100和所述第二螺旋部件。在图示所示实施方式 中，该第一固化胶172和第二固化胶174分别设置于第二螺旋部件120的两个端部，包覆第一螺旋部件100的两个端部的至少部分，用以将第一螺旋部件100固定于第二螺旋部件120。可以理解的是，第一固化胶172和第二固化胶174是通过在第二螺旋部件120外部进行点胶形成的，第一固化胶172可以为绕第二螺旋部件120一圈进行点胶形成的，也可以为在第二螺旋部件120外部至少一个点进行点胶形成的。
在一些实施方式中，固定部件还包括第三固化胶，该第三固化胶可以设置于第一固化胶172和第二固化胶174之间的任意位置，并分别耦接于第一螺旋部件100和第二螺旋部件120，用于将第一螺旋部件100固定于第二螺旋部件120。
图5是本发明第四实施例的栓塞物10的剖视图。与图3所示的实施方式类似，第一螺旋部件100包括基本同轴或轴向平行的第一螺旋单元102、第二螺旋单元104和第三螺旋单元106。此时，固定部件170可以包括第一固化胶172、第二固化胶174和第三固化胶176，该第一固化胶172和第二固化胶174分别设置于第二螺旋部件120的两个端部与第一螺旋单元102和第二螺旋单元104之间，用以将第一螺旋单元102和第二螺旋单元104固定于第二螺旋部件120。同时，第三固化胶176设置于第二螺旋部件120与第三螺旋单元106之间，用以将第三螺旋单元106固定于第二螺旋部件120。在其他实施方式中，螺旋单元和固化胶的数量不局限于此。
图6是本发明第五实施例的栓塞物10的剖视图。栓塞物10包括具有内腔110的管状的第一螺旋部件100、嵌套于第一螺旋部件100外侧面的第二螺旋部件120、至少部分置于所述第一螺旋部件100内腔110中的定型部件130和至少部分置于所述第一螺旋部件100内腔110中的固定部件170。其中，第一螺旋部件100、第二螺旋部件120和固定部件170的结构和使用方式和图2所示的实施方式中大致相同，在此不再重复说明。在一些实施方式中，定型部件130和第一螺旋部件100基本同轴或轴向平行。
如图6所示，定型部件130的远端132固定于第一螺旋部件100和第二螺旋部件120的远端140，定型部件130的近端134为自由端，设置于第一螺 旋部件100的近端内腔110中。在本申请的一个实施例中，定型部件130的远端132设置为倒J型弯钩，与第一螺旋部件100远端140的至少一个线圈连接，例如最后一个线圈，然后通过热熔或点胶的方式在第一螺旋部件100和第二螺旋部件120的远端140形成无创伤性的远侧尖端，将定型部件130的远端132与第一螺旋部件100和第二螺旋部件120的远端140彼此牢固地结合在一起，即将所述倒J型弯钩的至少部分与第一螺旋部件100和第二螺旋部件120的远端140包覆于该无创伤性的远侧尖端。该无创伤性的远侧尖端可以为图2所示的球帽150，也可以为圆锥形或椭圆形的封闭端。其中，该无创伤性的远侧尖端可由聚合物材料形成，例如聚酯、丙烯酸胶黏剂或其他适用于热熔或点胶的聚合物材料。在其他一些实施方式中，定型部件130的远端132也可以通过其他方式与第一螺旋部件100和第二螺旋部件120的远端140连接，例如，直型的、倒J型的或其他形状的定型部件130的远端132直接被球帽150包裹固定；或者定型部件130的远端132先与第二螺旋部件120的至少一个线圈连接后被球帽150包裹固定；又或者通过丝线物理缠绕或打结的方式将定型部件130连接于第一螺旋部件100和第二螺旋部件120的至少一端。
在一些实施方式中，定型部件130的近端134与第一螺旋部件100的近端160连接，远端132为自由端。也可以近端134和远端132分别与第一螺旋部件100的近端160和远端140连接。
在一些实施方式中，定型部件130包括至少一根定型丝材，其中每根定型丝材的截面为圆形、椭圆形或多边形，其直径不超过第一螺旋部件100的内径的90％，其中该第一螺旋部件的内径范围为0.001-0.01英寸。形成该定型部件130的材料为记忆合金，可为钴铬合金、镍钛合金和铂钨合金中的一种或几种。使用上述材料制造的定型部件130不仅增强了双层螺旋结构在血管及动脉瘤中的可视性，还可以对记忆合金进行立体预定型，用于提高栓塞物10的稳定性，使其在动脉瘤中可以具有更好的支撑性。在一些实施方式中，可以对定型部件130进行预定型，使其具有螺旋形、波浪形、四面体、五面体和六面体中的至少一种二级结构。
为实现上述目的，本发明还提供了一种栓塞物10制备方法，参考图6，主要包括下列步骤：
S1，将绕制好的第一螺旋部件100和定型部件130按照预设的形状分别在模具上进行预定型处理，其中，预设的形状可以为螺旋形(He l i ca l)、波浪形、四面体、五面体和六面体中的至少一种，第一螺旋部件100和定型部件130的预设形状也是互相对应的。
S2，将预定型好的定型部件130设置于预定型好的第一螺旋部件100的内腔110中，即，将丝状的定型部件130穿设于第一螺旋部件100的内腔110中，且将定型部件130的至少一端固定于第一螺旋部件100的至少一端。
S3，将固定部件170设置于第一螺旋部件100的内腔110中。
S4，将绕制好的第二螺旋部件120套设于绕制好的第一螺旋部件100外侧。
S5，将设置于第一螺旋部件100的内腔110中的固定部件170通过物理缠绕或打结的方式分别连接于第一螺旋部件100和第二螺旋部件120的两端，并在第二螺旋部件120的至少一端通过热熔或点胶的方式形成球帽150以进行封端，其中第一螺旋部件100和定型部件130的至少部分包覆于球帽150。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (28)

  1. 一种栓塞物，包括具有内腔的管状的第一螺旋部件、嵌套在所述第一螺旋部件外侧面的第二螺旋部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其特征在于，所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料，所述固定部件的两端分别连接于所述第二螺旋部件的两端，用以固定所述第一螺旋部件和所述第二螺旋部件。
  2. 如权利要求1所述的栓塞物，其特征在于，所述第一螺旋部件为铂、铱、金、银、钽和钨中的一种或其合金制成的金属部件。
  3. 如权利要求1所述的栓塞物，其特征在于，所述第一螺旋部件为基体中掺杂了显影物质的复合材料部件，其中，所述显影物质为碘造影剂或硫酸钡，所述基体为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖和透明质酸中的任意一种或几种。
  4. 如权利要求1所述的栓塞物，其特征在于，所述第二螺旋部件为聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚对二氧杂环己酮、聚己内酯、聚氨酯、壳聚糖、透明质酸、镁、镁合金、铁和铁合金中的任意一种或几种。
  5. 如权利要求1所述的栓塞物，其特征在于，所述固定部件为聚合物丝材，其中所述聚合物丝材为聚丙烯、尼龙、聚酯、聚乳酸、聚羟基乙酸、乳酸-羟基乙酸共聚物、聚己内酯中的任意一种或几种。
  6. 如权利要求5所述的栓塞物，其特征在于，所述聚合物丝材通过物理缠绕或打结的方式分别连接于所述第二螺旋部件的两端，用以固定所述第一螺旋部件和所述第二螺旋部件。
  7. 如权利要求6所述的栓塞物，其特征在于，所述聚合物丝材的两端通过打结的方式分别连接于所述第一螺旋部件和所述第二螺旋部件的两端。
  8. 如权利要求7所述的栓塞物，其特征在于，所述聚合物丝材对所述第一螺旋部件上的至少一圈螺旋和对所述第二螺旋部件上的至少一圈螺旋分别进行打结。
  9. 如权利要求7所述的栓塞物，其特征在于，所述聚合物丝材将所述第一螺旋部件上的至少一圈螺旋和所述第二螺旋部件上的至少一圈螺旋缠绕在 一起进行打结，以保持所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行。
  10. 如权利要求1所述的栓塞物，其特征在于，所述第一螺旋部件包括第一螺旋单元和第二螺旋单元，所述第一螺旋单元和所述第二螺旋单元同轴或轴向平行。
  11. 如权利要求10所述的栓塞物，其特征在于，所述固定部件为聚合物丝材，所述聚合物丝材分别穿过所述第一螺旋单元和所述第二螺旋单元的内腔，其中，所述聚合物丝材穿出所述第一螺旋单元和所述第二螺旋单元的部分连接于所述第二螺旋部件，用以固定所述第一螺旋单元、所述第二螺旋单元和所述第二螺旋部件。
  12. 如权利要求1所述的栓塞物，其特征在于，所述固定部件为固化胶，所述固化胶设置于所述第一螺旋部件和所述第二螺旋部件之间，且至少部分置于所述第一螺旋部件内腔中，用以固定所述第一螺旋部件和所述第二螺旋部件。
  13. 如权利要求12所述的栓塞物，其特征在于，所述固定部件包括第一固化胶和第二固化胶，所述第一固化胶和第二固化胶分别设置于所述第二螺旋部件的两个端部。
  14. 如权利要求13所述的栓塞物，其特征在于，所述固定部件还包括第三固化胶，所述第三固化胶设置于所述第一固化胶和第二固化胶之间的任意位置。
  15. 如权利要求1所述的栓塞物，其特征在于，所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行，和/或，所述第一螺旋部件的轴向长度不大于所述第二螺旋部件的轴向长度。
  16. 如权利要求1所述的栓塞物，其特征在于，所述第二螺旋部件的至少一端通过热熔或点胶的方式形成球帽以进行封端，其中，所述第一螺旋部件的端部也被包覆于所述球帽。
  17. 如权利要求16所述的栓塞物，其特征在于，所述固定部件靠近所述第二螺旋部件端部的至少部分也被包覆于所述球帽。
  18. 如权利要求16所述的栓塞物，还包括至少部分置于所述第一螺旋部件内腔中的定型部件，所述定型部件的一端被包覆于所述球帽。
  19. 如权利要求18所述的栓塞物，其特征在于，所述定型部件包括至少一根定型丝材，其中每根所述定型丝材的截面为圆形、椭圆形或多边形。
  20. 如权利要求18所述的栓塞物，其特征在于，所述定型部件的材料为钴铬合金、镍钛合金和铂钨合金中的任意一种或几种。
  21. 如权利要求18所述的栓塞物，其特征在于，所述定型部件具有螺旋形、波浪形、四面体、五面体和六面体中的至少一种二级定型结构。
  22. 如权利要求1所述的栓塞物，其特征在于，管状的所述第二螺旋部件的外径尺寸范围为0.005-0.05英寸，长度尺寸范围为0.5-200厘米，其中，绕制所述第二螺旋部件的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍尺寸范围为0.0005-0.005英寸。
  23. 如权利要求22所述的栓塞物，其特征在于，管状的所述第一螺旋部件的外径尺寸范围为0.002-0.02英寸，长度为管状的所述第二螺旋部件长度的10％-100％，其中，绕制所述第一螺旋部件的丝材的截面为圆形或圆形的一部分，该丝材的直径或曲率半径的2倍尺寸范围为0.0003-0.003英寸。
  24. 一种栓塞物，包括具有内腔的管状的第一螺旋部件、缠绕于所述第一螺旋部件外侧面的第二螺旋部件、至少部分置于所述第一螺旋部件内腔中的定型部件和至少部分置于所述第一螺旋部件内腔中的固定部件，其特征在于：
    所述第一螺旋部件包括不透射线材料，所述第二螺旋部件包括生物可吸收材料；
    所述固定部件通过物理缠绕或打结的方式分别连接于所述第二螺旋部件的两端；
    所述定型部件的一端固定于所述第一螺旋部件及所述第二螺旋部件的一端；以及
    所述第二螺旋部件的至少一端通过热熔或点胶的方式形成球帽以进行封端，所述第一螺旋部件和所述定型部件的至少部分包覆于所述球帽。
  25. 一种如权利要求1-24中任一项所述的栓塞物制备方法，其特征在于，包括下列步骤：
    将绕制好的所述第一螺旋部件按照预设的形状在模具上进行预定型处理；
    将所述固定部件设置于所述第一螺旋部件的内腔中；以及
    将绕制好的所述第二螺旋部件套设于绕制好的所述第一螺旋部件外侧。
  26. 如权利要求25所述的制备方法，其特征在于，还包括：
    将绕制好的所述定型部件按照预设的形状在模具上进行预定型处理；
    将预定型好的所述定型部件设置于预定型好的所述第一螺旋部件的内腔中；
    将设置于所述第一螺旋部件的内腔中的所述固定部件通过物理缠绕或打结的方式分别连接于所述第一螺旋部件和所述第二螺旋部件的两端；以及
    将所述定型部件的一端与所述第一螺旋部件及所述第二螺旋部件的一端固定在一起。
  27. 如权利要求26所述的制备方法，其特征在于，所述聚合物丝材与所述第一螺旋部件和所述第二螺旋部件的打结方式为所述聚合物丝材先对内圈的所述第一螺旋部件上的至少一圈螺旋打结后，再对外圈的所述第二螺旋部件上的至少一圈螺旋打结。
  28. 如权利要求26所述的制备方法，其特征在于，所述聚合物丝材与所述第一螺旋部件和所述第二螺旋部件的打结方式为所述聚合物丝材同时对所述第一螺旋部件上的至少一圈螺旋和所述第二螺旋部件上的至少一圈螺旋打结，以保持所述第一螺旋部件和所述第二螺旋部件同轴或轴向平行。
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