WO2022267904A1 - 一种医用植入物及其制造方法 - Google Patents

一种医用植入物及其制造方法 Download PDF

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Publication number
WO2022267904A1
WO2022267904A1 PCT/CN2022/098135 CN2022098135W WO2022267904A1 WO 2022267904 A1 WO2022267904 A1 WO 2022267904A1 CN 2022098135 W CN2022098135 W CN 2022098135W WO 2022267904 A1 WO2022267904 A1 WO 2022267904A1
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Prior art keywords
coil unit
coil
unit
medical implant
shaped
Prior art date
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PCT/CN2022/098135
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English (en)
French (fr)
Inventor
张广建
杨波
王洪杰
刘梦钦
郭澜涛
苗铮华
Original Assignee
上海鸿脉医疗科技有限公司
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Publication of WO2022267904A1 publication Critical patent/WO2022267904A1/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
    • A61B17/12099—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
    • A61B2017/00526—Methods of manufacturing

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical implant and a manufacturing method thereof.
  • Aneurysm is a localized bulging or fusiform dilated lesion due to arterial wall disease or injury, which has a serious impact on the health of patients.
  • endovascular interventional therapy has become the first choice for the treatment of aneurysms because it has less risk and trauma than surgical treatment.
  • Aneurysm embolization coils are currently the main method for treating aneurysms.
  • the coils expand into a predetermined shape in the aneurysm and achieve corresponding embolization effects.
  • the coils may have different shapes and/or different cross-sectional diameters.
  • the coils are delivered in a small-diameter elongated form and deployed into a blood vessel, and then the coils assume two-dimensional or 3D shapes such as spindles, bird's nests, and the like.
  • Coil coils are flexible in structure and can be delivered through narrow or tortuous vascular structures, but when relatively large vascular structures need to be occluded, multiple coils may need to be used simultaneously.
  • the immediate embolization density is one of the important factors affecting the long-term stability of the embolization structure. Therefore, the greater the packing density of the coils in the aneurysm, the better the clinical effect of aneurysm treatment. beneficial.
  • the existing coils include coils with three-dimensional structure and coils with two-dimensional structure. In most cases, the coils with three-dimensional structure need to cooperate with the coils with two-dimensional structure to form a complete coil system.
  • the coils are mainly used to form a basket and form a space frame in the aneurysm, so as to be stably supported in the aneurysm and cover the open area, and then use the two-dimensional structure of the coil to fill the remaining space in the aneurysm to finally form Dense embolization of an aneurysm.
  • the end profile of the existing three-dimensional coils is a planar structure, which cannot fully conform to the shape of the aneurysm, resulting in the coil system not being able to completely embolize the aneurysm.
  • the object of the present invention is to provide a medical implant and a manufacturing method thereof.
  • the medical implant is used for embolization of hemangiomas, which can well conform to the shape of hemangiomas, and is conducive to improving the compactness of packing, improving treatment effect.
  • the present invention provides a medical implant, comprising a coil, the coil comprises a first coil unit and a second coil unit, the first coil unit and the second coil
  • the coil units are connected; the outer surface of the first coil unit is located on the first curved surface, and the concave side of the first curved surface is arranged toward the second coil unit.
  • the first coil unit includes at least two basic units of different shapes, each of which is O-shaped, C-shaped or ⁇ -shaped.
  • the first coil unit has two opposite ends, one basic unit at one end is connected to the second coil unit, and one basic unit at the other end is O-shaped.
  • the outer surface of the second coil unit is located on a second curved surface, and the concave side of the second curved surface is arranged toward the first coil unit.
  • the second spring coil unit includes at least two basic units of different shapes, each of which is O-shaped, C-shaped or ⁇ -shaped.
  • the second coil unit has two opposite ends, one basic unit at one end is connected to the first coil unit, and one basic unit at the other end is O-shaped.
  • the spring coil further includes a third coil unit, and the first coil unit is connected to the second coil unit through the third coil unit.
  • the third coil unit includes at least three basic units, and at least three basic units are arranged in a three-dimensional structure.
  • At least three of the basic units in the third coil unit have the same or different shapes, and the basic units are C-shaped, O-shaped or S-shaped.
  • the medical implant further includes a coagulation-promoting structure, and the coagulation-promoting structure is arranged on the spring coil.
  • the present invention also provides a manufacturing method of a medical implant, for preparing the aforementioned medical implant, the manufacturing method comprising:
  • the primary coil is formed by helically winding metal, alloy or polymer wires.
  • the manufacturing method further includes: setting a coagulation-promoting structure on the spring coil.
  • the medical implant of the present invention Compared with the prior art, the medical implant of the present invention and its manufacturing method have the following advantages:
  • the aforementioned medical implant includes a coil, the coil includes a first coil unit and a second coil unit, the first coil unit is connected to the second coil unit, and the first spring
  • the outer surface of the coil unit is located on the first curved surface, the concave side of the first curved surface is arranged toward the second coil unit, and when the medical implant is implanted into the tumor cavity of the hemangioma, the first spring
  • the coil unit is used to support on the tumor wall opposite to the neck opening of the hemangioma
  • the second coil unit is used to cover the neck opening of the hemangioma and is supported on the tumor wall at the opening, both of which are formed in the hemangioma
  • the outer surface of the first coil unit of the medical implant is located on the first curved surface, so that the first coil unit can conform to the shape of the tumor wall, which is beneficial to improve the compactness of packing and improve the treatment effect.
  • the outer surface of the second coil unit is located on the second curved surface, and the concave side of the second curved surface is arranged toward the first coil unit. This setting can further help to improve the compactness of the spring coil packing.
  • the spring coil also includes a third coil unit, the first coil unit is connected to the second coil unit through the third coil unit; the concave side of the first curved surface and the The concave side of the second curved surface is arranged facing the third coil unit, so that when the medical implant is implanted in the hemangioma, the third coil unit is directly used to fill all the hemangioma cavity.
  • the remaining space between the first coil unit and the second coil unit promotes thrombusization, without additional implantation of other embolism structures, which simplifies operation and shortens operation time.
  • first coil unit Using the first coil unit, the second coil unit and the third coil unit to construct a relatively smooth three-dimensional curved surface structure, so that the medical implant conforms to the shape of the hemangioma to the greatest extent, In order to achieve a better embolization effect.
  • Fig. 1 is a schematic structural view of a medical implant provided by Embodiment 1 of the present invention.
  • Fig. 2 is a schematic structural view of the spring coil of the medical implant provided by Embodiment 1 of the present invention.
  • Fig. 3 is a schematic structural view of the spring coil of the medical implant provided by Embodiment 1 of the present invention, and the viewing directions of Fig. 3 and Fig. 2 are different;
  • FIG. 4 is a schematic structural view of the primary coil of the medical implant provided by Embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural view of the mold of the medical implant provided by Embodiment 1 of the present invention.
  • Fig. 6 is a schematic diagram of winding a spring coil on a mold in Embodiment 1 of the present invention.
  • Fig. 7 is a schematic diagram of setting a coagulation-promoting structure on the coil in Embodiment 1 of the present invention.
  • Fig. 8 is a schematic structural view of the medical implant provided by Embodiment 2 of the present invention.
  • Fig. 9 is a schematic structural view of the spring coil of the medical implant provided by the second embodiment of the present invention.
  • Fig. 10 is a schematic structural view of the spring coil of the medical implant provided by Embodiment 2 of the present invention, and the viewing orientation of Fig. 10 is different from that of Fig. 9;
  • Fig. 11 is a schematic structural view of the mold of the medical implant provided by the second embodiment of the present invention.
  • Embodiments of the present invention are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.
  • the present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.
  • the diagrams provided in this embodiment are only schematically illustrating the basic idea of the present invention, and only the components related to the present invention are shown in the diagrams rather than the number, shape and shape of the components in actual implementation. Dimensional drawing, the shape, quantity and proportion of each component can be changed arbitrarily during actual implementation, and the layout of the components may also be more complicated.
  • each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • the medical implant provided by the embodiment of the present invention includes a coil 100, and the coil 100 includes a first coil unit 110 and a second coil unit 120, so The first coil unit 110 is connected to the second coil unit 120 .
  • the first coil unit 110 is a three-dimensional structure, and the outer surface of the first coil unit 110 is located on a first curved surface, and the concave side of the first curved surface is arranged toward the second coil unit 120 (That is, the center of curvature of the first curved surface is located on a side of the first coil unit 110 close to the second coil unit 120 ).
  • the medical implant can be used for occlusion treatment of hemangiomas, and the hemangiomas include but not limited to intracranial aneurysms, and can also be peripheral aneurysms.
  • the second coil unit 120 is supported on the tumor wall at the opening of the neck of the hemangioma and covers the opening, and the first coil unit 110 is supported on the tumor wall opposite the opening, so the first The coil unit 110 and the second coil unit 120 form a basket, that is, the first coil unit 110 and the second coil unit 120 form a space frame within the hemangioma.
  • the outer surface of the first coil unit 110 is located on the first curved surface, so that the first coil unit 110 can conform to the shape of the hemangioma, which is conducive to improving the compactness of hemangioma packing and improving the treatment effect.
  • the coil is a three-dimensional structure, which is used to fill the tumor cavity of the hemangioma and promote the thrombus of the hemangioma.
  • the outer surface of the first coil unit 110 is located on the first curved surface, including the situation that the outer surface of the first coil unit 110 is strictly located on the first curved surface, and also includes the first coil unit
  • the outer surface of 110 is substantially located on the first curved surface.
  • the outer surface of the second coil unit 120 is located on a second curved surface, and the concave side of the second curved surface is arranged opposite to the concave side of the first curved surface (that is, the curvature of the second curved surface
  • the center is located on the side of the second coil unit 120 close to the first coil unit 110), so that the second coil unit 120 can adapt to the tumor wall around the opening of the hemangioma, and further improve the compactness of hemangioma packing sex.
  • the first spring coil unit 110 includes at least two basic units of different shapes, the shape of the basic unit of the first spring coil unit 110 is O One of C-shaped, C-shaped or ⁇ -shaped, that is, the basic unit of the first spring coil unit 110 can be at least two of the O-shaped basic unit, the C-shaped basic unit or the ⁇ -shaped basic unit. A combination, wherein the O-shaped basic unit and the ⁇ -shaped basic unit have good stability and are not easily deformed, so the stability of the first spring coil unit 110 can be maintained.
  • the number of the basic units included in the first coil unit 110 is selected according to actual needs, such as two, three, four or five, and the shape of each basic unit is also selected according to needs.
  • one of the two basic units at the two ends of the first coil unit 110 is connected to the second coil unit 120 (including the basic unit directly connected to the second coil unit 120 case, including the case where the basic unit is indirectly connected to the second coil unit 120 through the third coil unit 130 mentioned later), the shape of the other one is preferably O-shaped.
  • the first coil unit 110 includes three basic units connected in sequence, if the third basic unit is connected to the second coil unit 120, the first basic unit
  • the shape of the first spring coil unit 110 is O-shaped, so that when the first coil unit 110 is supported on the tumor wall opposite to the opening, the tumor wall will not be scratched.
  • the second coil unit 120 may have a configuration similar to that of the first coil unit 110 . That is, the second coil unit 120 includes at least two basic units, and at least some of the basic units have different shapes.
  • the shape of the basic unit of the second coil unit 120 is O-shape, C-shape or ⁇ -shape.
  • the number of the basic units included in the second spring coil unit 120 is selected according to actual needs, such as two, three, four or five.
  • the shape of each of the basic units is also selected according to needs. Therefore, the second coil unit 120 is combined with the first coil unit 110 to form a frame structure, provide good support performance, and adapt to the shape of the hemangioma.
  • one of the two basic units located at the two ends of the second coil unit 120 is connected to the first coil unit 110 (including the basic unit and the first coil unit 110 is directly connected to the situation, also including the situation that the basic unit is indirectly connected to the first coil unit 110 through the third coil unit 130), the shape of the other is O-shaped, so that the When the second coil unit 120 is arranged at the opening of the hemangioma, it is avoided that the free end of the second coil unit 120 protrudes into the true lumen of the blood vessel and scratches the wall of the blood vessel.
  • first coil unit 110 and the second coil unit 120 can be arranged symmetrically or asymmetrically, and the first curved surface and the second curved surface can be spherical A part may also be an aspheric surface, which is not limited in this embodiment of the present invention.
  • O shape mentioned in the embodiment of the present invention includes but is not limited to a circle, and may also be an ellipse or an irregularly shaped closed loop. Those skilled in the art should know that "closed loop" refers to There are no openings when viewed axially, rather than referring to a closed ring structure connected end to end.
  • the C-shape includes but is not limited to circular arcs, and may also be elliptical arcs, circular arcs with different curvatures, or open loops such as "concave" shapes including partial straight lines and partial arc shapes.
  • the ⁇ -shape refers to an open loop whose opening radian is smaller than that of the C-shape, which also includes but is not limited to a circular arc.
  • the arc length of the C shape is greater than or equal to 50% of the circumference and less than 75% of the circumference, and the arc length of the ⁇ shape is greater than or equal to 75% of the circumference and less than 100% of the circumference.
  • the spring coil 100 only includes the first coil unit 110 and the second coil unit 120, the first coil unit 110 and the second coil unit The spaces between the units 120 are implanted with other embolic structures to fill the tumor cavity and promote thrombusization.
  • the spring coil 100 further includes a third coil unit 130 , and the first coil unit 110 is connected to the second coil unit 120 through the third coil unit 130 . That is, the first coil unit 110 , the third coil unit 130 and the second coil unit 120 are connected in sequence. Moreover, both the concave side of the first curved surface and the concave side of the second curved surface are arranged facing the third spring coil unit 130 .
  • the third coil unit 130 is directly used to fill the space between the first coil unit 110 and the second coil unit 120 , and promote thrombusization, no need to implant other embolism structures, simplify the operation, shorten the operation time, and after the hemangioma is completely embolized, the blood flow cannot enter the tumor cavity, reduce the blood flow pressure of the hemangioma, and avoid rupture risk.
  • the third spring coil unit 130 includes at least three basic units, and the shapes of at least three basic units are the same or different.
  • the shape of the basic unit is C-shaped, O-shaped or S-shaped, and at least three of the basic units are properly arranged so that the third spring coil unit 130 is configured as a three-dimensional structure with good compliance, Furthermore, the space between the first coil unit 110 and the second coil unit 120 can be densely packed.
  • the third coil unit 130 can be a single-layer structure or a multi-layer structure.
  • the spring coil 100 can be obtained by winding and shaping the primary coil on a mold, so that the spring coil 100 can be stretched into an elongated structure with a smaller radial dimension during delivery , easy to transport.
  • the primary coil may be a cylindrical spring structure formed by helically winding metal, alloy or polymer wires around an axial direction.
  • the primary coil includes a first segment, a second segment and a third segment, wherein the first segment is used to wind the first coil unit 110, and the axis of the first segment is preferably Located on the third curved surface, so that the outer surface of the first coil unit 110 is located on the first curved surface.
  • the second segment is used to wind the third coil unit 130 .
  • the third segment is used to wind the second coil unit 120, and the axis of the third segment is located on the fourth curved surface, so that the outer surface of the second coil unit 120 is located on on the second surface.
  • the primary coil has an integrated structure.
  • the first segment, the second segment, and the third segment may also be formed separately and wound into corresponding coil units and then connected together.
  • the medical implant also includes a coagulation-promoting structure, and the coagulation-promoting structure is arranged on the spring coil 100 .
  • the coagulation-promoting structure is the embolism-promoting fluff 210 wound on the coil 100, and the embolism-promoting fluff 210 can be polymer cilia, and the specific material can be PET, PA, PGLA At least one of them can be fully drawn yarn (FDY) or drawn textured yarn (DTY).
  • the material of the embolization-promoting fluff 210 can also be a natural fiber material.
  • the embolism-promoting fluff 210 can be wound on the primary coil (winding 1 to 5 turns), and clamped and fixed by two adjacent helical coils of the primary coil, and the embolism-promoting fluff 210
  • the length of 210 may be 1mm-20mm.
  • the coagulation-accelerating structure may also be a coagulation-accelerating coating, such as a hydrogel coating, coated on the outer surface of the spring coil 100 .
  • an embodiment of the present invention also provides a method for manufacturing a medical implant, which is used for manufacturing the aforementioned medical implant.
  • the manufacturing method includes the following steps: firstly, a primary coil 10 (as shown in FIG. 4 ) is provided. Next, the primary coil 10 is routed according to a mold 20 (as shown in FIG. 5 and FIG. 6 ), so as to wind the spring coil 100 on the mold 20 . Finally, the spring coil 100 is shaped.
  • a metal wire with a diameter of 0.5mm-2mm is helically wound along a mandrel to form a cylindrical helical spring structure, and then the mandrel is pulled away to obtain the primary coil 10 (as shown in FIG. 4 ).
  • the mold 20 includes a main body 21 and a boss 22 .
  • the main body 21 includes a cylinder 21a and a first hemisphere 21b and a second hemisphere 21c respectively disposed at two ends of the cylinder 21a.
  • the cross-section of the protruding posts 22 is circular, and the number of the protruding posts 22 is ten, wherein three of the protruding posts 22 are evenly arranged around the axis of the first hemispherical body 21b, and four of the protruding posts 22 are arranged uniformly around the axis of the first hemisphere 21b.
  • the columns 22 are evenly arranged around the axis of the cylinder 21a, and the remaining three convex columns 22 are evenly arranged around the axis of the second hemispherical body 21c (as shown in FIG. 5 ).
  • the primary coil 10 is routed along the mold 20 and wound to form the spring coil 100 .
  • the primary coil 10 starts from one of the protrusions 22 on the first hemispherical body 21b, and then goes around the remaining two protrusions on the first hemispherical body 21b in turn. 22, and then turn around the four bosses 22 on the cylinder 21a, and finally turn around the three bosses 22 on the second hemisphere 21c to form the spring ring 100 ( As shown in Figure 6).
  • the basic unit is formed when the primary coil 10 goes around the protrusion 22 , so the shape of each basic unit is determined by the wiring path of the primary coil 10 .
  • an O-shaped basic unit, an ⁇ -shaped basic coil and a C-shaped basic coil are sequentially formed.
  • the path of the primary coil 10 is controlled to form four basic units, and the shapes of the four basic units include O-shaped, C-shaped and S-shaped. At least two.
  • a C-shaped basic unit, an ⁇ -shaped basic unit and an O-shaped basic unit are sequentially formed.
  • the C-shaped basic unit of the first coil unit 110 and the C-shaped basic unit of the second coil unit 120 are respectively connected to the third coil unit 130 .
  • the mold 20 together with the spring coil 100 is put into a heat treatment furnace for heat treatment, so as to shape the spring coil 100 .
  • the heat treatment temperature is 500°C-700°C, and the time is 60min-120min.
  • the spring ring 100 is removed from the mold 20 to obtain the spring ring 100 as shown in FIGS. 2 and 3 .
  • the first curved surface where the outer surface of the first coil unit 110 is located is a hemispherical surface
  • the second curved surface where the outer surface of the second coil unit 120 is located is also a hemispherical surface
  • the outer surfaces of the three coil units 130 are located on a circumferential surface, that is, the third coil unit 130 is formed as a cylindrical three-dimensional structure as a whole.
  • the third coil unit 130 at least includes a C-shaped or S-shaped basic unit, and the C-shaped or S-shaped has better turning performance and compressibility, which effectively improves the compliance of the third coil unit 130, and has Conducive to the formation of dense embolism within the tumor.
  • the spring coil 100 is straightened to temporarily return to the shape of the elongated primary coil 10, and a certain gap exists between any two adjacent helical coils of the primary coil 10, and then the embolization-promoting fluff 210 wound on the spring coil 100 (as shown in FIG. 7 ).
  • the third spring coil unit 130 when winding the spring coil 100, if the primary coil 10 completes a round of wire routing on the cylinder 21a, it will be wound on the cylinder 21a again.
  • the third spring coil unit 130 By bypassing the four bosses 22 above, the third spring coil unit 130 with a double-layer structure can be obtained. Repeating the wiring on the cylinder 21a for many times can obtain all coil units with more layers. Describe the third coil unit 130.
  • the first curved surface where the outer surface of the first spring unit 110 is located is A part of the ellipsoid
  • the second curved surface on which the outer surface of the second coil unit 120 is located is a part of the ellipsoid.
  • the shape of the curved surface where the outer surface of the third spring coil unit 130 is located is also changed accordingly, for example, when the cylinder is replaced with a frustum of cone structure, The outer surface of the third coil unit 130 is located on a conical surface.
  • the difference between this embodiment and the first embodiment lies in that the number and arrangement of the protrusions 22 on the mold 20 are different.
  • the mold 20 includes sixteen protrusions 22, three of which are uniformly arranged around the axis of the first hemisphere 21b, and three protrusions 22 Evenly arranged around the axis of the second hemisphere 21c, the remaining ten protruding posts 22 are divided into a first protruding post group and a second protruding post group, and each group includes five protruding posts 22 .
  • the first protruding post group is close to the first hemispherical body 21b, and the five protruding posts 22 in this group are uniformly arranged around the circumference of the cylinder 21a.
  • the second protruding post group is close to the second hemispherical body 21c, and the five protruding posts 22 in this group are uniformly arranged around the circumference of the cylinder 21a.
  • the protrusions 22 in the two protrusion groups are arranged in a staggered manner.
  • the primary coil 10 starts from one of the protruding posts 22 on the first hemispherical body 21b, and goes around the other two protruding posts on the first hemispherical body 21b in turn. twenty two. Then according to the bosses 22 in the second boss group, the bosses 22 in the first boss group, the bosses 22 in the second boss group, the bosses in the first boss group Protruding pillars 22 are wound in sequence until the wiring on the cylinder 21a is completed, and finally the three protruding pillars 22 on the second hemispherical body 21c are sequentially wound to form the spring ring 100 .
  • the first spring coil unit 110 includes an O-shaped basic unit, an ⁇ -shaped basic unit and an O-shaped basic unit connected in sequence.
  • the third coil unit 130 includes nine S-shaped basic units (it can also be said to be ten C-shaped basic units, two adjacent C-shaped basic units are spliced into an S-shaped basic unit), and the third spring The outer surface of the ring unit 130 is located on a cylindrical surface.
  • the second spring coil unit 120 is sequentially connected with an O-shaped basic unit, an ⁇ -shaped basic unit and an O-shaped basic unit.
  • the embolism-promoting fluff 210 can also be provided on the spring coil 100 .
  • the medical implant provided by the embodiment of the present invention includes a coil, and the coil at least includes a first coil unit and a second coil unit, and the first coil unit and the second coil unit The units are connected, and the outer surface of the first spring coil unit is located on the first curved surface, the outer surface of the second spring coil unit is located on the second curved surface, and the concave side of the second curved surface is in line with the first curved surface The concave sides are arranged oppositely.
  • the coil can conform to the shape of the tumor wall of the hemangioma, which is conducive to improving the compactness of packing and improving the treatment effect.

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Abstract

提供了一种医用植入物及其制造方法。医用植入物包括弹簧圈(100)，弹簧圈(100)包括第一弹簧圈单元(110)和第二弹簧圈单元(120)，第一弹簧圈单元(110)与第二弹簧圈单元(120)连接。第一弹簧圈单元(110)的外表面位于第一曲面上，第一曲面的凹侧朝向第二弹簧圈单元(120)布置。医用植入物用于血管瘤的封堵治疗，第一弹簧圈单元(110)能够适应血管瘤的瘤壁的形状，有利于提高瘤内栓塞的致密性，改善治疗效果。

Description

一种医用植入物及其制造方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种医用植入物及其制造方法。
背景技术
动脉瘤是由于动脉壁病变或损伤形成的局限性膨出或梭形扩张性病变，对患者的健康造成严重影响。随着影像技术和血管内生物材料的发展，血管内介入治疗因比外科手术治疗具有更小的风险和创伤，已成为治疗动脉瘤的首选方法。
动脉瘤腔内栓塞弹簧圈是目前治疗动脉瘤的主要方法，在弹簧圈栓塞动脉瘤的过程中，弹簧圈在动脉瘤内扩张成预定形状，并取得相应的栓塞效果。为了将弹簧圈装配至不同大小的血管结构并使其闭塞，弹簧圈可以具有不同的形状和/或不同的横截面直径。在使用时，弹簧圈以小直径的细长形态输送并被部署至血管中，然后弹簧圈呈现二维或3D形状例如纺锤形、鸟巢形等。弹簧线圈的结构灵活，且能够通过狭窄或曲折的血管结构完成输送，但当需要闭塞相对较大的血管结构时，可能需要同时使用多个弹簧圈。对于动脉瘤的治疗来说，即刻的栓塞致密程度是影响栓塞结构长期稳定性的重要因素之一，因此，弹簧圈在动脉瘤内的填塞致密度越大，对提高动脉瘤治疗的临床效果越有益。
现有的弹簧圈包括三维结构的弹簧圈和二维结构的弹簧圈，大多数情况下，三维结构的弹簧圈需要与二维结构的弹簧圈相配合以构成完整的弹簧圈系统，其中三维结构的弹簧圈主要用于形成篮圈并在动脉瘤内形成空间框架，以稳定地支撑在动脉瘤内，并覆盖开阔的区域，然后利用二维结构的弹簧圈填充瘤内剩余的空间以最终形成动脉瘤的致密栓塞。然而，现有的三维结构的弹簧圈的端部轮廓呈平面结构，不能完全顺应动脉瘤的形态，导致弹簧圈系统不能完全栓塞动脉瘤。
发明内容
本发明的目的在于提供一种医用植入物及其制造方法，所述医用植入物用于血管瘤栓塞，其能够很好地顺应血管瘤的形态，并有利于提高填塞的致密性，改善治疗效果。
为实现上述目的，本发明提供了一种医用植入物，包括弹簧圈，所述弹簧圈包括第一弹簧圈单元和第二弹簧圈单元，所述第一弹簧圈单元与所述第二弹簧圈单元连接；所述第一弹簧圈单元的外表面位于第一曲面上，所述第一曲面的凹侧朝向所述第二弹簧圈单元布置。
可选地，所述第一弹簧圈单元包括至少两种不同形状的基本单元，每个所述基本单元的形状为O形、C形或Ω形。
可选地，所述第一弹簧圈单元具有相对的两端，位于一端的一个所述基本单元与所述第二弹簧圈单元连接，位于另一端的一个所述基本单元的形状为O形。
可选地，所述第二弹簧圈单元的外表面位于第二曲面上，所述第二曲面的凹侧朝向所述第一弹簧圈单元布置。
可选地，所述第二弹簧圈单元包括至少两种不同形状的基本单元，每个所述基本单元的形状为O形、C形或Ω形。
可选地，所述第二弹簧圈单元具有相对的两端，位于一端的一个所述基本单元与所述第一弹簧圈单元连接，位于另一端的一个所述基本单元的形状为O形。
可选地，所述弹簧圈还包括第三弹簧圈单元，所述第一弹簧圈单元通过所述第三弹簧圈单元与所述第二弹簧圈单元连接。
可选地，所述第三弹簧圈单元包括至少三个基本单元，至少三个所述基本单元布置成三维立体结构。
可选地，所述第三弹簧圈单元中的至少三个所述基本单元的形状相同或不相同，且所述基本单元的形状为C形、O形或S形。
可选地，所述医用植入物还包括促凝结构，所述促凝结构设置在所述弹簧圈上。
为实现上述目的，本发明还提供了一种医用植入物的制造方法，用于制备 如前所述的医用植入物，所述制造方法包括：
提供一初级线圈；
使所述初级线圈根据一模具进行走线，以在所述模具上绕制形成所述弹簧圈；以及，
定形处理。
可选地，所述初级线圈由金属、合金或高分子线材螺旋卷绕形成。
可选地，所述制造方法还包括：在所述弹簧圈上设置促凝结构。
与现有技术相比，本发明的医用植入物及其制造方法具有如下优点：
前述的医用植入物包括弹簧圈，所述弹簧圈包括第一弹簧圈单元和第二弹簧圈单元，所述第一弹簧圈单元与所述第二弹簧圈单元连接，且所述第一弹簧圈单元的外表面位于第一曲面上，所述第一曲面的凹侧朝向所述第二弹簧圈单元布置，将所述医用植入物植入血管瘤的瘤腔时，所述第一弹簧圈单元用于支撑在血管瘤颈部开口对面的瘤壁上，所述第二弹簧圈单元用于覆盖血管瘤的颈部开口并支撑在开口处的瘤壁上，两者在血管瘤内形成空间框架，该医用植入物的第一弹簧圈单元的外表面位于第一曲面上，使得所述第一弹簧圈单元能够顺应瘤壁的形状，有利于提高填塞的致密性，改善治疗效果。
进一步地，所述第二弹簧圈单元的外表面位于第二曲面上，所述第二曲面的凹侧朝向所述第一弹簧圈单元设置。这样设置，可进一步有利于提高弹簧圈填塞的致密性。
再进一步地，所述弹簧圈还包括第三弹簧圈单元，所述第一弹簧圈单元通过所述第三弹簧圈单元与所述第二弹簧圈单元连接；所述第一曲面的凹侧和所述第二曲面的凹侧均面向所述第三弹簧圈单元布置，如此当所述医用植入物植入血管瘤内时，直接利用所述第三弹簧圈单元填塞血管瘤腔内的所述第一弹簧圈单元及所述第二弹簧圈单元之间的剩余空间并促进血栓化，无需额外植入其他栓塞结构，简化操作，缩短手术时间。利用所述第一弹簧圈单元、所述第二弹簧圈单元以及所述第三弹簧圈单元构建出较为平滑的三维空间曲面结构，使得所述医用植入物最大程度地顺应血管瘤的形态，以达到更好的栓塞效果。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1是本发明实施例一所提供的医用植入物的结构示意图；
图2是本发明实施例一所提供的医用植入物的弹簧圈的结构示意图；
图3是本发明实施例一所提供的医用植入物的弹簧圈的结构示意图，图3与图2的观察方位不同；
图4是本发明实施例一所提供的医用植入物的初级线圈的结构示意图；
图5是本发明实施例一所提供的医用植入物的模具的结构示意图；
图6是本发明实施例一中在模具上绕制弹簧圈的示意图；
图7是本发明实施例一中在弹簧圈上设置促凝结构的示意图；
图8是本发明实施例二所提供的医用植入物的结构示意图；
图9是本发明实施例二所提供的医用植入物的弹簧圈的结构示意图；
图10是本发明实施例二所提供的医用植入物的弹簧圈的结构示意图，图10的观察方位与图9不同；
图11是本发明实施例二所提供的医用植入物的模具的结构示意图。
[附图标记说明如下]：
100-弹簧圈，110-第一弹簧圈单元，120-第二弹簧圈单元，130-第三弹簧圈单元；
210-促栓绒毛；
10-初级线圈；
20-模具，21-主体部，21a-圆柱体，21b-第一半球体，21c-第二半球体，22-凸柱。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可 以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的形态、数量及比例可为一种随意的改变，且其组件布局形态也可能更为复杂。
另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。
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。
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。附图中相同或相似的附图标记代表相同或相似的部件。
请参考图1至图3及图8至图11，本发明实施例提供的医用植入物包括弹簧圈100，所述弹簧圈100包括第一弹簧圈单元110和第二弹簧圈单元120，所述第一弹簧圈单元110与所述第二弹簧圈单元120连接。所述第一弹簧圈单元110为三维立体结构，且所述第一弹簧圈单元110的外表面位于一第一曲面上，所述第一曲面的凹侧朝向所述第二弹簧圈单元120布置(也即所述第一曲面的曲率中心位于所述第一弹簧圈单元110靠近所述第二弹簧圈单元120的一侧)。所述医用植入物可用于血管瘤的封堵治疗，所述血管瘤包括但不限于颅内动脉瘤，还可以是外周动脉瘤。使用时，所述第二弹簧圈单元120支撑在血管瘤颈部开口处的瘤壁上，并覆盖开口，所述第一弹簧圈单元110支撑在开口对面的瘤壁上，因此所述第一弹簧圈单元110和所述第二弹簧圈单元120形成篮圈，也即所述第一弹簧圈单元110和所述第二弹簧圈单元120在血管瘤内形成空间框架。所述第一弹簧圈单元110的外表面位于第一曲面上，使得所述第一弹簧圈单元110能够顺应血管瘤的形态，有利于提高血管瘤填塞的致密性，改善治疗效果。本领域技术人员可以理解，所述弹簧圈是一种三维结构，其用于填塞血管瘤的瘤腔，并促进血管瘤血栓化。以及，所述第一弹簧圈单元110的外表面位于第一曲面上，包括所述第一弹簧圈单元110的外表面严格地位于第一曲面上的情形，也包括所述第一弹簧圈单元110的外表面大致地位于第一曲面上的情形。
优选地，所述第二弹簧圈单元120的外表面位于一第二曲面上，所述第二曲面的凹侧与所述第一曲面的凹侧相对布置(也即所述第二曲面的曲率中心位于所述第二弹簧圈单元120靠近所述第一弹簧圈单元110的一侧)，以使所述第二弹簧圈单元120适应血管瘤开口周边的瘤壁，进一步提高血管瘤填塞的致密性。
请重点参考图2、图3、图9及图10，所述第一弹簧圈单元110包括至少 两种不同形状的基本单元，所述第一弹簧圈单元110的所述基本单元的形状为O形、C形或Ω形中的一种，也即所述第一弹簧圈单元110的所述基本单元可以是O形的基本单元、C形的基本单元或Ω形的基本单元中的至少两种组合，其中O形的基本单元和Ω形的基本单元的稳定性好，不易变形，因而能够保持所述第一弹簧圈单元110的稳定性。
所述第一弹簧圈单元110所包括的所述基本单元的数量根据实际需要选择，例如两个、三个、四个或五个，且各个所述基本单元的形状亦根据需要选择。通常，所述第一弹簧圈单元110的两端的两个所述基本单元中的一者与所述第二弹簧圈单元120连接(包括该基本单元与所述第二弹簧圈单元120直接相连的情形，也包括该基本单元通过后文中述及的第三弹簧圈单元130与所述第二弹簧圈单元120间接相连的情形)，另一者的形状优选为O形。具体来说，当所述第一弹簧圈单元110包括三个依次连接的基本单元时，若第三个所述基本单元与所述第二弹簧圈单元120连接，则第一个所述基本单元的形状为O形，如此当所述第一弹簧圈单元110支撑在开口对面的瘤壁上时，不会划伤瘤壁。
所述第二弹簧圈单元120可具有与所述第一弹簧圈单元110相似的配置。也即，所述第二弹簧圈单元120包括至少两个所述基本单元，且至少部分所述基本单元的形状不相同。所述第二弹簧圈单元120的所述基本单元的形状为O形、C形或Ω形。所述第二弹簧圈单元120所包括的所述基本单元的数量根据实际需要选择，例如两个、三个、四个或五个。各个所述基本单元的形状亦根据需要选择。因此，所述第二弹簧圈单元120与所述第一弹簧圈单元110组合以形成框架结构并提供良好的支撑性能，且适应血管瘤的形状。
以及，位于所述第二弹簧圈单元120的两个端部的两个所述基本单元中的一者与所述第一弹簧圈单元110连接(包括该基本单元与所述第一弹簧圈 单元110直接相连的情形，也包括该基本单元通过所述第三弹簧圈单元130与所述第一弹簧圈单元110间接相连的情形)，另一者的形状为O形，这样设置，使得所述第二弹簧圈单元120布置在血管瘤的开口处时，避免所述第二弹簧圈单元120的自由端伸入血管真腔进而划伤血管壁的情况。
需要说明的是，所述第一弹簧圈单元110与所述第二弹簧圈单元120可以对称布置，也可以不对称地布置，以及，所述第一曲面以及所述第二曲面可以是球面的一部分也可以是非球面，本发明实施例对此不作限定。还需要说明的是，本发明实施例所述的O形包括但不限于圆形，也可以是椭圆形或不规则形状的闭环，本领域技术人员应当知晓的是“闭环”是指沿环形的轴向观察没有开口，而非是指首尾相连的封闭环形结构。这里，C形包括但不限于圆弧，也可以是椭圆弧、具有不同曲率的圆弧或包括部分直线和部分弧形的“凹”字形等开环。Ω形是指开口弧度小于C形的开口弧度的开环，其同样包括但不限于圆弧。可选地，C形的弧长大于或等于周长的50％且小于圆周的75％，Ω形的弧长大于或等于周长的75％且小于圆周的100％。
本领域技术人员可理解，当所述弹簧圈100仅包括所述第一弹簧圈单元110和所述第二弹簧圈单元120时，可通过在第一弹簧圈单元110及所述第二弹簧圈单元120之间的空间植入其他栓塞结构来填塞瘤腔，并促进血栓化。
优选地，所述弹簧圈100还包括第三弹簧圈单元130，所述第一弹簧圈单元110通过所述第三弹簧圈单元130与所述第二弹簧圈单元120连接。也即，所述第一弹簧圈单元110、所述第三弹簧圈单元130及所述第二弹簧圈单元120依次连接。并且，所述第一曲面的凹侧和所述第二曲面的凹侧均面向所述第三弹簧圈单元130布置。这样一来，所述医用植入物在植入血管瘤之后，所述第三弹簧圈单元130直接用于填塞所述第一弹簧圈单元110与所述第二弹簧圈单元120之间的空间，并促进血栓化，无需再额外植入其他的栓塞结 构，简化手术操作，缩短手术时间，且血管瘤被完全栓塞后，血流无法进入瘤腔，减小血管瘤的血流压力，避免破裂风险。
所述第三弹簧圈单元130包括至少三个所述基本单元，且至少三个所述基本单元的形状相同或不相同。所述基本单元的形状为C形、O形或S形，至少三个所述基本单元通过合适的排布方式以使所述第三弹簧圈单元130构造成具有良好顺应性的三维立体结构，进而可致密地填塞所述第一弹簧圈单元110和所述第二弹簧圈单元120之间的空间。所述第三弹簧圈单元130可以是单层结构也可以是多层结构。
本实施例中，所述弹簧圈100可通过初级线圈在模具上绕制并定形得到，这样做，使得所述弹簧圈100在输送过程中能够被拉伸成具有较小径向尺寸的细长结构，便于输送。所述初级线圈可以是由金属、合金或高分子线材绕一轴向螺旋卷绕而成的圆柱弹簧结构。所述初级线圈包括第一节段、第二节段和第三节段，其中所述第一节段用于绕成所述第一弹簧圈单元110，且所述第一节段的轴线优选位于第三曲面上，以使所述第一弹簧圈单元110的外表面位于所述第一曲面上。所述第二节段用于绕成所述第三弹簧圈单元130。以及，所述第三节段用于绕成所述第二弹簧圈单元120，且所述第三节段的轴线位于第四曲面上，以使所述第二弹簧圈单元120的外表面位于所述第二曲面上。优选的，所述初级线圈为一体式结构。替代性地，所述第一节段、所述第二节段、及所述第三节段也可分体成型并分别绕制成对应的弹簧圈单元后再连接于一体。
不仅如此，所述医用植入物还包括促凝结构，所述促凝结构设置在所述弹簧圈100上。在一个示范性的实施例中，所述促凝结构为缠绕在所述弹簧圈100上的促栓绒毛210，所述促栓绒毛210可以是高分子纤毛，具体材质可以是PET、PA、PGLA中的至少一种，既可以是全拉伸丝(FDY)，也可以是 拉伸变形丝(DTY)。所述促栓绒毛210的材质还可以是天然纤维材料。实际设置时，所述促栓绒毛210可缠绕在初级线圈上(缠绕1圈～5圈)，并被所述初级线圈的相邻两个所述螺旋线圈夹紧固定，且所述促栓绒毛210的长度可以为1mm～20mm。当所述弹簧圈100被拉伸成细长结构时，相邻两个促栓绒毛210之间的距离为5mm～20mm。替代性的实施例中，所述促凝结构还可以是涂覆于所述弹簧圈100之外表面上的促凝涂层，例如水凝胶涂层。
进一步地，本发明实施例还提供了一种医用植入物的制造方法，用于制造前述的医用植入物。所述制造方法包括如下步骤：首先，提供一初级线圈10(如图4所示)。接着，使所述初级线圈10根据一模具20走线(如图5及图6所示)，以在所述模具20上绕制形成所述弹簧圈100。最后，对所述弹簧圈100进行定形处理。
接下去结合实例说明所述医用植入物制造方法及制得的所述医用植入物。
<实施例一>
首先，将一直径为0.5mm～2mm的金属丝沿一芯轴螺旋缠绕并形成圆柱螺旋弹簧结构，然后抽离所述芯轴，得到初级线圈10(如图4所示)。
接着，提供一模具20，所述模具20包括主体部21和凸柱22。本实施例中，所述主体部21包括圆柱体21a和分别设置在所述圆柱体21a两端的第一半球体21b和第二半球体21c。所述凸柱22的横截面为圆形，且所述凸柱22的数量为十个，其中三个所述凸柱22绕所述第一半球体21b的轴线均匀布置，四个所述凸柱22绕所述圆柱体21a的轴线均匀布置，剩余三个所述凸柱22绕所述第二半球体21c的轴线均匀布置(如图5所示)。
随后，使所述初级线圈10沿所述模具20开始走线，并绕制形成所述弹簧圈100。在绕制过程中，所述初级线圈10从所述第一半球体21b上的一个 所述凸柱22开始走线，然后依次绕过所述第一半球体21b上的其余两个所述凸柱22，再依次绕过所述圆柱体21a上的四个所述凸柱22，最后依次绕过所述第二半球体21c上的三个所述凸柱22，形成所述弹簧圈100(如图6所示)。本领域技术人员应知晓，所述初级线圈10在绕过所述凸柱22时形成所述基本单元，因此每个所述基本单元的形状由所述初级线圈10的走线路径决定。本实施例中，所述初级线圈10在所述第一半球体21b上走线时，依次形成一个O形的基本单元、一个Ω形的基本线圈和一个C形的基本线圈。在所述圆柱体21a上走线时，控制所述初级线圈10的路径，以形成四个所述基本单元，并使四个所述基本单元的形状包括O形、C形及S形中的至少两种。在所述第二半球体21c上走线时，依次形成一个C形的基本单元、一个Ω形的基本单元和一个O形的基本单元。所述第一弹簧圈单元110的C形基本单元以及所述第二弹簧圈单元120的C形基本单元分别与所述第三弹簧圈单元130连接。
之后，将所述模具20连同所述弹簧圈100一起放入热处理炉进行热处理，以对所述弹簧圈100定型。热处理的温度为500℃～700℃，时间为60min～120min。
然后，将所述弹簧圈100从所述模具20上取下，得到如图2及图3所示的弹簧圈100。本实施例中，所述第一弹簧圈单元110的外表面所在的第一曲面为半球面，所述第二弹簧圈单元120的外表面所在的第二曲面也为半球面，以及所述第三弹簧圈单元130的外表面位于一圆周面上，也即所述第三弹簧圈单元130整体形成为圆柱形的三维结构。由于所述第一弹簧圈单元110和所述第二弹簧圈单元120均包括Ω形的基本单元和O形的基本单元，因此两者的稳定性好，使得所述弹簧圈100具有较好的支撑性，还不容易移位。所述第三弹簧圈单元130至少包括C形或S形的基本单元，C形或S形具有较 好的转弯性能和可压缩性，有效提高所述第三弹簧圈单元130的顺应性，有利于形成瘤内的致密栓塞。
最后，将所述弹簧圈100拉直，使其暂时恢复成细长的初级线圈10的形态，并使初级线圈10的任意相邻两个螺旋圈之间存在一定间隙，再将促栓绒毛210缠绕在所述弹簧圈100上(如图7所示)。
本领域技术人员应理解，本实施例中，在绕制所述弹簧圈100时，若所述初级线圈10在所述圆柱体21a上完成一圈的走线后，再次在所述圆柱体21a上绕过四个所述凸柱22，则可以得到双层结构的所述第三弹簧圈单元130，重复在所述圆柱体21a上进行多次走线，则可以得到层数更多的所述第三弹簧圈单元130。此外，若将所述模具20的所述第一半球体21b和/或所述第二半球体21c替换为椭球体的一部分，则所述第一弹簧单元110的外表面所在的第一曲面为椭球面的一部分，和/或所述第二弹簧圈单元120的外表面所在的第二曲面为椭球面的一部分。以及，若将所述模具20的圆柱体21a替换为其他形状，所述第三弹簧圈单元130的外表面所在的曲面的形状也相应改变，例如当所述圆柱体被替换为圆台结构时，所述第三弹簧圈单元130的外表面则位于一圆锥面上。
<实施例二>
本实施例与实施例一的区别之处在于，所述模具20上的凸柱22的数量及排布方式不同。具体地，请参考图11，所述模具20包括十六个所述凸柱22，其中三个所述凸柱22绕所述第一半球体21b的轴线均匀布置，三个所述凸柱22绕所述第二半球体21c的轴线均匀布置，剩余十个所述凸柱22被划分为第一凸柱组和第二凸柱组，每组各包括五个所述凸柱22。所述第一凸柱组靠近所述第一半球体21b，且该组中的五个所述凸柱22绕所述圆柱体21a 的周向均匀布置。所述第二凸柱组靠近所述第二半球体21c，且该组中的五个所述凸柱22绕所述圆柱体21a的周向均匀布置。在所述圆柱体21a的周向上，两个凸柱组中的所述凸柱22错开布置。
绕制过程中，所述初级线圈10从所述第一半球体21b上的一个所述凸柱22开始走线，并依次绕过所述第一半球体21b上的另两个所述凸柱22。接着按照所述第二凸柱组内的凸柱22、所述第一凸柱组内的凸柱22、所述第二凸柱组内的凸柱22、所述第一凸柱组内的凸柱22……的顺序绕制，直至完成在所述圆柱体21a上的走线，最后依次绕过所述第二半球体21c上的三个所述凸柱22，形成所述弹簧圈100。
对所述模具20和位于所述模具20上的所述弹簧圈100加热定型后取下所述弹簧圈100，其结构如图9及图10所示。本实施例中，所述第一弹簧圈单元110包括依次连接的一个O形的基本单元、一个Ω形的基本单元和一个O形的基本单元。所述第三弹簧圈单元130包括九个S形的基本单元(也可以说是十个C形基本单元，相邻两个C形基本单元拼接成S形基本单元)，且所述第三弹簧圈单元130的外表面位于一圆柱面上。所述第二弹簧圈单元120依次连接一个O形的基本单元、一个Ω形的基本单元和一个O形的基本单元。
完成所述弹簧圈100的定型后，还可以在所述弹簧圈100上设置所述促栓绒毛210。
综上，本发明实施例所提供的医用植入物包括弹簧圈，所述弹簧圈至少包括第一弹簧圈单元和第二弹簧圈单元，所述第一弹簧圈单元与所述第二弹簧圈单元连接，且所述第一弹簧圈单元的外表面位于第一曲面上，所述第二弹簧圈单元的外表面位于第二曲面上，所述第二曲面的凹侧与所述第一曲面的凹侧相对布置。当利用所述医用植入物对血管瘤进行栓塞治疗时，所述弹簧圈能够顺应血管瘤的瘤壁的形状，有利于提高填塞的致密性，改善治疗效 果。
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形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形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形在内。

Claims (13)

  1. 一种医用植入物，其特征在于，包括弹簧圈，所述弹簧圈包括第一弹簧圈单元和第二弹簧圈单元，所述第一弹簧圈单元与所述第二弹簧圈单元连接；所述第一弹簧圈单元的外表面位于第一曲面上，所述第一曲面的凹侧朝向所述第二弹簧圈单元布置。
  2. 根据权利要求1所述的医用植入物，其特征在于，所述第一弹簧圈单元包括至少两种不同形状的基本单元，每个所述基本单元的形状为O形、C形或Ω形。
  3. 根据权利要求2所述的医用植入物，其特征在于，所述第一弹簧圈单元具有相对的两端，位于一端的一个所述基本单元与所述第二弹簧圈单元连接，位于另一端的一个所述基本单元的形状为O形。
  4. 根据权利要求1所述的医用植入物，其特征在于，所述第二弹簧圈单元的外表面位于第二曲面上，所述第二曲面的凹侧朝向所述第一弹簧圈单元布置。
  5. 根据权利要求4所述的医用植入物，其特征在于，所述第二弹簧圈单元包括至少两种不同形状的基本单元，每个所述基本单元的形状为O形、C形或Ω形。
  6. 根据权利要求5所述的医用植入物，其特征在于，所述第二弹簧圈单元具有相对的两端，位于一端的一个所述基本单元与所述第一弹簧圈单元连接，位于另一端的一个所述基本单元的形状为O形。
  7. 根据权利要求1或4所述的医用植入物，其特征在于，所述弹簧圈还包括第三弹簧圈单元，所述第一弹簧圈单元通过所述第三弹簧圈单元与所述第二弹簧圈单元连接。
  8. 根据权利要求7所述的医用植入物，其特征在于，所述第三弹簧圈单元包括至少三个基本单元，至少三个所述基本单元布置成三维立体结构。
  9. 根据权利要求8所述的医用植入物，其特征在于，所述第三弹簧圈单元中的至少三个所述基本单元的形状相同或不相同，且所述基本单元的形状 为C形、O形或S形。
  10. 根据权利要求1所述的医用植入物，其特征在于，所述医用植入物还包括促凝结构，所述促凝结构设置在所述弹簧圈上。
  11. 一种医用植入物的制造方法，用于制备如权利要求1-9中任一项所述的医用植入物，其特征在于，所述制造方法包括：
    提供一初级线圈；
    使所述初级线圈根据一模具进行走线，以在所述模具上绕制形成所述弹簧圈；以及，
    定形处理。
  12. 根据权利要求11所述的医用植入物的制造方法，其特征在于，所述初级线圈由金属、合金或高分子线材螺旋卷绕形成。
  13. 根据权利要求11或12所述的医用植入物的制造方法，其特征在于，所述制造方法还包括在所述弹簧圈上设置促凝结构。
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