WO2019033978A1 - 栓塞线圈输送装置及其制备方法 - Google Patents

栓塞线圈输送装置及其制备方法 Download PDF

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Publication number
WO2019033978A1
WO2019033978A1 PCT/CN2018/099541 CN2018099541W WO2019033978A1 WO 2019033978 A1 WO2019033978 A1 WO 2019033978A1 CN 2018099541 W CN2018099541 W CN 2018099541W WO 2019033978 A1 WO2019033978 A1 WO 2019033978A1
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Prior art keywords
wire
embolic coil
conductive wire
coil
type
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PCT/CN2018/099541
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English (en)
French (fr)
Inventor
郭远益
彭云飞
陈冰
常孟琪
于海瑞
金巧蓉
王亦群
谢志永
Original Assignee
微创神通医疗科技（上海）有限公司
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Application filed by 微创神通医疗科技（上海）有限公司 filed Critical 微创神通医疗科技（上海）有限公司
Priority to BR112020003021-0A priority Critical patent/BR112020003021A2/pt
Priority to JP2020509114A priority patent/JP7026779B2/ja
Priority to ES18847082T priority patent/ES2937238T3/es
Priority to US16/639,456 priority patent/US11172934B2/en
Priority to EP18847082.7A priority patent/EP3669799B1/en
Priority to KR1020207007381A priority patent/KR102365255B1/ko
Publication of WO2019033978A1 publication Critical patent/WO2019033978A1/zh
Priority to PH12020500348A priority patent/PH12020500348A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00831—Material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00929—Material properties isolating electrical current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/1209—Details concerning the detachment of the occluding device from the introduction device detachable by electrical current or potential, e.g. electroactive polymer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • the invention relates to the field of medical instruments, in particular to an embolic coil conveying device and a preparation method thereof.
  • the development of endovascular intervention provides new techniques for the treatment of intracranial aneurysms. Especially since the advent of embolic coils, the safety and efficacy of intravascular treatment of intracranial aneurysms has been greatly improved, and craniotomy has been achieved. Effect.
  • the embolization coil is usually released in the cerebral aneurysm cavity, thereby causing a thrombus in the cavity to achieve the purpose of embolizing the aneurysm.
  • embolic coils mainly include mechanical release coils, electrothermal melting coils and electrolytic decoupling coils.
  • the most used ones are electrolytic decoupling coils, mainly Boston Scientific GDC and Target coils.
  • GDC electrolysis decoupling cavity is a percutaneous vascular puncture and is introduced through a microcatheter. The aneurysm, the portion of the embolization coil connected to the stainless steel guide wire is dissolved by electrolysis, and the embolic coil is released from the aneurysm, thereby preventing blood flow into the aneurysm.
  • the key step in embolization of intracranial aneurysms is that the microcatheter is accurately positioned and can be fixed in the tumor cavity.
  • the end of the microcatheter is kept in the tumor cavity near 1/3 to 1/2 of the tumor neck.
  • Small aneurysms can be placed. At the neck of the aneurysm, this resistance is small and facilitates the entanglement of the embolic coil.
  • release area a significant problem with Boston Scientific's GDC and Target coils, Medtronic's (Ev3) Axium coils, Microvention's MicroPlex coils and HydroCoil coils is the release area between the coil and the push rod (release area) It refers to the area where the embolic coil and the push rod are connected, and the release point that is broken by electrolysis is located in the area. However, the release area is not equal to the release point, but refers to the softness change from the distal end of the push rod.
  • the length of the release zone of the tube and the ball is 2.0 mm.
  • microcatheter can easily cause the microcatheter to kick out (ie, the coil that is released at the end of the microcatheter in the tumor cavity is kicked out of the tumor cavity, and the end of the microcatheter falls into the parent artery).
  • the microcatheter At present, an average of 5 to 6 coils need to be filled in the aneurysm for treatment, and the external kicking effect causes the microcatheter to shift, which is bound to cause the doctor to reposition the microcatheter in the tumor cavity near the neck of the tumor. Blocking the coils increases the difficulty of the doctor repositioning the microcatheter, prolonging the operation time or causing the surgery to fail.
  • the push rod and the spring ring of the mechanical release spring ring are separated by an anchor module; the push rod and the spring ring of the electric heat melting release spring are separated by a heating module; in addition, the existing push rod and spring of the electrolytic decoupling coil An insulation module is placed between the rings.
  • the present invention provides an embolic coil conveying device comprising a push rod and an embolization coil, wherein a distal end of the push rod and a proximal end of the embolization coil are connected to a release area, wherein the embolic coil is transported
  • the device also includes:
  • a primary anti-rotation wire disposed in the embolic coil, the anti-drawing wire being fixed on a coil of the proximal end of the embolic coil; and a conductive wire disposed to pass through the interior of the push rod, the conductive
  • the wire is covered with an insulating layer, and the distal end of the conductive wire is provided with a release point that does not cover the insulating layer, and the distal end of the conductive wire and the proximal end of the anti-rotation wire are cross-connected.
  • the anti-twisting wire is fixed on any one of the 2nd to 6th coils at the proximal end of the embolization coil.
  • the release elastic region has a flexural modulus of 150 to 220 MPa.
  • the release region has a length of 0.3 mm to 1.0 mm.
  • the distal end of the conductive wire has a “J” shape, a “U” shape or a “T” shape
  • the proximal end of the anti-twisting wire has a “J” shape.
  • the conductive wire is cross-connected with the anti-winding UU type, UJ type cross connection, JU type cross connection, JJ type cross connection, TU type cross connection or TJ type cross connection.
  • the conductive wire and the anti-spinning wire cross-link are coated with polymer glue.
  • the material of the insulating layer comprises at least one of polytetrafluoroethylene, polyethylene terephthalate, polyether amide, and polyimide.
  • the embolic coil delivery device further includes a detacher, the proximal end of the push rod is inserted into the detacher, and the detacher is configured to apply a direct current of 0.5 mA to 5.0 mA to the Conductive wire.
  • the embolic coil is in an " ⁇ "-like basket type or a spiral type.
  • the invention also provides a preparation method of the embolic coil conveying device as described above, comprising:
  • a proximal end of the anti-drawing wire is cross-linked to a distal end of the conductive filament.
  • the anti-twisting wire is fixed on any one of the second to sixth coils at the proximal end of the embolization coil.
  • the distal end of the conductive wire is in a “J” shape, a “U” shape or a “T” shape, and the proximal end of the anti-drawing wire is “ J" type or "U” type
  • the conductive wire is cross-connected with the anti-winding UU type, UJ type cross connection, JU type cross connection, JJ type cross connection, TU type cross connection or TJ type cross connection.
  • the method for preparing the embolic coil conveying device further comprises applying a polymer glue at the cross joint.
  • the push rod and the embolic coil are included, and the distal end of the push rod and the proximal end of the embolic coil are connected as a release region, and an anti-rotation wire is disposed at the embolization In the coil, the anti-winding wire is fixed at a proximal end of the embolic coil, a conductive wire is disposed in the push rod, and the anti-twisting wire is connected to the conductive wire.
  • the present invention fixes the anti-twisting wire on the coil of the proximal end of the embedding coil, and provides an insulating layer on the conductive wire, and sets a release point of the uncovered insulating layer at the distal end of the conductive wire.
  • the anti-twisting wire is cross-connected with the conductive wire such that the conductive wire and the anti-drawing wire are wound and fixed on the coil at the proximal end of the embolic coil, such a structure reduces the length of the de-coring region, and the relief region can be further
  • the condition that the microcatheter is kicked out after the embolization coil is placed is basically avoided, and the success rate of the operation is improved.
  • Figure 1 is a schematic view showing the structure of an embolic coil conveying device of the present invention
  • Figure 2 is a schematic view showing the structure of the release region and the embolic coil of Figure 1;
  • FIG. 3 is a schematic view showing the connection between the anti-twisting wire and the conductive wire in an embodiment of the present invention
  • FIG. 4 is a schematic view showing the connection between the anti-twisting wire and the conductive wire in an embodiment of the present invention
  • Figure 5 is a schematic view showing the connection between the anti-twisting wire and the conductive wire in an embodiment of the present invention
  • FIG. 6 is a schematic view showing the connection between the anti-twisting wire and the conductive wire in an embodiment of the present invention
  • Figure 7 is a schematic view showing the connection of the anti-twisting wire and the conductive wire in an embodiment of the present invention.
  • Figure 8 is a schematic view of an embolic coil in accordance with an embodiment of the present invention.
  • Figure 9 is a schematic view of an embolic coil in accordance with an embodiment of the present invention.
  • FIG. 10 is a schematic view showing a bending elastic modulus test of a release region according to an embodiment of the present invention.
  • embolic coil delivery device of the present invention and its method of preparation are described in more detail below with reference to the accompanying drawings, in which a preferred embodiment of the present invention is illustrated, and it is understood that those skilled in the art can modify the invention described herein Advantageous effects of the invention. Therefore, the following description is to be understood as a broad understanding of the invention, and is not intended to limit the invention.
  • the present invention provides an embolic coil delivery device comprising a push rod and an embolization coil, an anti-rotation wire being disposed in the embolic coil, the anti-rotation wire being fixed on a coil portion at a proximal end of the embolization coil, a conductive wire disposed to pass through the inside of the push rod, the conductive wire is covered with an insulating layer, and a distal end of the conductive wire is provided with a release point of the uncovered insulating layer, the anti-twisting wire and the conductive wire Cross connection.
  • Such a structural design omits the intermediate module between the conductive wire and the embolic coil, reduces the length of the disengagement region, and makes the release region softer, substantially avoiding the situation in which the microcatheter kicks out after the embolization coil is placed. Increased the success rate of surgery.
  • the embolic coil delivery device of the present invention includes a push rod 106 and an embolic coil 107.
  • the distal end of the push rod 106 and the proximal end of the embolic coil 107 are connected to a release region 103.
  • the so-called release area refers to a section from the sudden change of the softness of the distal end of the push rod to the sudden change of the softness of the proximal end of the embolization coil, which is located at the junction of the push rod and the embolic coil, and is disconnected by electrolysis. The point is located in the area.
  • An anti-rotation wire is disposed inside the embolization coil, the anti-spinning wire is fixed at a proximal end of the embolization coil 107, a conductive wire 104 passes through a center of the push rod 106, and the conductive wire 104 is covered with An insulating layer, wherein the insulating layer is made of at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyether amide (PEBAX), and polyimide (Polyimide). .
  • the anti-winding wire is cross-connected to the conductive filament 104.
  • distal and proximal are relative concepts of the respective ends of each component or module, for example, one end near the operator is defined as “near end” and the end far from the operator is defined as “Remote”, which is well known in the art, is not explained too much here.
  • the anti-drawing wire 108 is fixed to any one of the second to sixth coils of the proximal end 1071 of the embolization coil.
  • the anti-winding wire 108 is connected to the conductive wire 104, and the two are not required to be connected through the intermediate transfer module, and the anti-rotation wire 108 is fixed on the plug coil 107, and can also be realized. Stable and will not fall off. In this way, the softness of the release zone can be ensured and the length of the release zone can be reduced as much as possible.
  • the embolization coil 107 which is disengaged at the end of the microcatheter in the tumor cavity, can be effectively prevented from kicking out of the tumor cavity.
  • the release region 103 has a length of 0.3 mm to 1.0 mm.
  • the distal end of the conductive filament 104 and the proximal end of the anti-rotation wire 108 are cross-connected. Referring to Figures 3-7, various alternatives are illustrated.
  • the distal end of the conductive filament 104 has a "J” shape, a "U” shape, or a “T” shape
  • the proximal end of the anti-rotation wire 108 has a "J" shape or a "U” shape.
  • the distal end of the conductive wire 104 is of a "U” shape
  • the proximal end of the anti-rotation wire 108 is of a "U” shape, so that the UU-type cross-connection is realized.
  • the distal end of the conductive wire 104 is of a "J" shape
  • the proximal end of the anti-rotation wire 108 is of a "U” shape, so that the UJ-type cross-connection is realized.
  • the distal end of the conductive wire 104 is of a "J" shape
  • the proximal end of the anti-rotation wire 108 is of a "J” shape, so that the JJ type cross-connection is realized.
  • the distal end of the conductive wire 104 is in a "T” shape
  • the proximal end of the anti-rotation wire 108 is in a "J" shape to realize a TJ-type cross connection.
  • the distal end of the conductive wire 104 is of a "T” shape
  • the proximal end of the anti-rotation wire 108 is of a "U” shape, so that the TU type cross-connection is realized.
  • the embolic coil 107 and the push rod 106 can be maintained at a certain joint strength while effectively transmitting the force to the embolic coil 107.
  • the delivery of the embolization coil 107 is ensured.
  • connection of the conductive wire 104 and the anti-drawing wire 108 is not limited to the form enumerated in the present invention, and those skilled in the art can flexibly select other possible ways.
  • the anti-winding wire 108 is coated with a polymer glue at the junction of the conductive filaments 104 to enhance the joint strength.
  • the polymer glue may be a UV glue, an epoxy glue or the like.
  • the conductive filament 104 includes a coating region 1042 (ie, an insulating layer) and a bare region 1041, which is a narrow region located at the distal end of the conductive filament 104.
  • the push rod 106 and the plug coil 107 are separated by electrolysis in the body fluid, and are therefore also referred to as a release point.
  • the coating material of the coating region 1042 includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyether amide (PEBAX), and polyimide (Polyimide). kind.
  • PTFE polytetrafluoroethylene
  • PET polyethylene terephthalate
  • PEBAX polyether amide
  • Polyimide Polyimide
  • the conductive filaments 104 may be made of a metal such as a bio-efficient metal such as stainless steel, gold, silver, iron, or the like.
  • the embolic coil delivery device further includes a detacher 105, the proximal end of the push rod 106 is inserted into the detacher 105, and the detacher 105 applies a direct current of 0.5 mA to 5.0 mA to
  • the conductive wire 104 more specifically, a current of, for example, 1.0 mA to 3.0 mA, can safely and quickly separate the embolic coil 107 and the push rod 106.
  • the detacher 105 can be hand held for ease of operation.
  • the push rod 106 includes a connected metal tube 101 and a metal spring tube 102.
  • the metal spring tube 102 can be 40-50 cm in length and can smoothly pass through the intracranial curve above the aortic arch. Blood vessels.
  • the distal end 1021 of the metal spring tube 102 is the distal end of the push rod 106; and the proximal end of the metal tube 101 can be inserted into the detacher 105.
  • the embolization coil 107 When the embolization coil 107 is brought into an approximately straight state by introduction into the sheath tube and the associated microcatheter (not shown), the embolization coil 107 is delivered to the lesion by the push rod 106. When the embolization coil 107 enters the lesion by the microcatheter, the secondary shape is restored and conforms to the shape of the lesion, and the embolization coil 105 can be released from the distal end of the push rod by the external releaser 105 to complete the implantation.
  • the secondary form of the embolic coil 107 is of an " ⁇ "-like basket type or a spiral type.
  • other shapes of embolic coils 107 can be provided to accommodate different sizes of tumors depending on different needs.
  • the invention also provides a preparation method of an embolic coil conveying device, comprising:
  • the anti-drawing wire is coupled to the conductive filament such that the distal end of the push rod and the proximal end of the embolic coil are connected as a relief region.
  • the anti-spinning wire is attached to any of the second to sixth coils of the embolic coil.
  • the method further comprises: coating a polymer glue at a junction of the anti-winding wire and the conductive wire to enhance the connection strength .
  • the embolic coil can be made of a platinum alloy wire, and the platinum alloy coils can have different lengths and diameters.
  • a platinum alloy wire chain may be wound around the mandrel to form a primary coil; then the wound primary coil is wound on the mold in accordance with a predetermined shape and shaped, for example, to obtain a secondary form of " ⁇ " basket type or spiral type structure.
  • the platinum alloy coil is made of a 0.003 inch diameter wire chain wound on a metal mandrel to form a tight primary coil that acts as a plug coil 107 that pre-sets the wound primary coil.
  • the second-stage form of the good " ⁇ "-shaped basket type is wound and subjected to a setting process, that is, the obtained secondary form of the plug coil 107 is of the " ⁇ " type basket type.
  • the distal end of the conductive wire 104 is made into a "U" shape (as shown in FIG. 3); the anti-rotation wire 108 is extended in the axial direction of the primary coil inside the embedding coil 107 (see a partial cross-sectional view in FIG. 2), And the anti-spinning wire 108 is cross-connected with the "U"-shaped distal end of the conductive wire 104 to form a U-shaped proximal end (as shown in FIG. 3), and one side of the proximal end "U” of the anti-rotation wire 108 is fixedly wound around the embolic coil.
  • One of the second to sixth coils of the proximal end of 107 (shown in Figure 2), the other side returns to the distal end of the embolic coil 107, and optionally a ball cap at the distal end of the embolic coil 107 To fix it.
  • An insulating layer 1042 is disposed on the conductive wire 104, and a release point 1041 (shown in FIG. 3) that is not covered with an insulating layer is disposed at a distal end thereof to form a relief at a cross-connection area of the conductive wire 104 and the anti-drawing wire 108.
  • the release region 103 has a length of 0.5 mm.
  • the flexural modulus of the release region 103 was found to be 150 MPa according to the three-point bending method shown in FIG.
  • the three-point bending method shown in FIG. 10 may be that after the conductive wire 104 and the anti-drawing wire 108 are cross-connected to form the release region 103, the metal spring tube 102 and the embolic coil 107 are respectively clamped by the fixing device 200, and then A bending force is calculated by applying a certain force to the release region 103, for example, by pressing down 10 mm.
  • the structure of the embolic coil 107 is made in a helical shape (as shown in Figure 9), and the platinum alloy coil is made of a wire chain having a diameter of 0.00125 inches, and similarly, it is wound tightly on a metal mandrel.
  • the wound primary coil is shaped according to a predetermined shape "spiral type".
  • the distal end of the conductive wire 104 is made into a "J" shape (as shown in FIG. 4); the anti-drawing wire 108 is extended axially along the primary coil, and the "J"-shaped distal end of the anti-aliasing wire 108 and the conductive wire 104 are formed.
  • a U-shaped proximal end is formed (as shown in FIG. 4), and one side of the proximal end "U" of the anti-rotation wire 108 is fixed to any one of the second to sixth coils wound around the proximal end of the embolization coil 107 ( As shown in FIG. 2, the other side returns to the distal end of the embolization coil 107.
  • An insulating layer is disposed on the conductive wire, and a release point of the uncovered insulating layer is disposed at a distal end of the conductive wire, and a release region 103 is formed by a cross-connected region of the conductive wire 104 and the anti-drawing wire 108, the release region 103
  • the length is 1.0mm.
  • the flexural modulus of the release region 103 was found to be 210 MPa according to the three-point bending method shown in FIG.
  • the structure of the embolic coil 107 is made in a helical shape (as shown in Figure 9), and the platinum alloy coil is made of a wire chain having a diameter of 0.002 inches, and similarly, it is wound tightly on a metal mandrel.
  • the wound primary coil is shaped according to a predetermined shape "spiral type".
  • the distal end of the conductive wire 104 is formed into a "J" shape (as shown in FIG. 5); the anti-drawing wire 108 is extended axially along the primary coil, and the "J"-shaped distal end of the anti-aliasing wire 108 and the conductive wire 104 are After the cross-connection, a "J"-shaped proximal end is formed (as shown in FIG. 5), and one side of the proximal end "J" of the anti-rotation wire 108 is fixedly wound around the third coil at the proximal end of the embolization coil 107.
  • An insulating layer is disposed on the conductive wire, and a release point of the uncovered insulating layer is disposed at a distal end of the conductive wire, and a release region 103 is formed by a cross-connected region of the conductive wire 104 and the anti-drawing wire 108, the release region 103
  • the length is 0.5mm.
  • the flexural modulus of the release region 103 was found to be 150 MPa according to the three-point bending method shown in FIG.
  • the distal end of the conductive filament 104 is designed to be "T" shaped (as shown in Figures 6 and 7); the anti-rotation wire 108 extends axially along the primary coil and is resistant to the vicinity of the anti-rotation wire 108 The end is designed as a "J" type (as shown in FIG. 6) or a "U” type (as shown in FIG. 7); an insulating layer is disposed on the conductive wire, and an uncovered insulating layer is disposed at a distal end of the conductive wire. The point is released and the conductive filaments 104 are cross-linked to the anti-drawing wire 108.
  • the push rod and the embolic coil are included, and the distal end of the push rod and the proximal end of the embolic coil are connected as a release region, and the anti-unwinding a wire disposed in the embolic coil, the anti-twisting wire being fixed at a proximal end of the embolic coil, a conductive wire disposed in the push rod, the conductive wire being provided with an insulating layer, and the conductive wire The distal end is provided with a release point that does not cover the insulating layer, and the anti-twisting wire is connected to the conductive filament.
  • the present invention fixes the anti-twisting wire at the proximal end of the embolic coil, so that the anti-drawing wire is connected with the conductive wire, thereby reducing the length of the de-coring region, and making the disengagement region It is softer and basically avoids the situation that the microcatheter kicks out after the embolization coil is placed, which improves the success rate of the operation.

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Abstract

本发明揭示了一种栓塞线圈输送装置及其制备方法，包括推送杆和栓塞线圈，所述推送杆的远端和栓塞线圈的近端相连接作为解脱区域，一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈的近端，一导电丝设置在所述推送杆中，所述抗解旋丝与所述导电丝相连接。相比现有技术，本发明是将抗解旋丝固定在栓塞线圈的近端，从而所述抗解旋丝与所述导电丝相连接，因此降低了解脱区域的长度，且使得解脱区域可以更为柔软，避免了栓塞线圈放置后使得微导管外踢的状况发生。

Description

栓塞线圈输送装置及其制备方法 技术领域
本发明涉及医疗器械领域，具体地说是一种栓塞线圈输送装置及其制备方法。
背景技术
血管内介入治疗的开展为颅内动脉瘤的治疗提供了新技术，尤其是栓塞线圈问世以来，使得目前血管内治疗颅内动脉瘤的安全性和疗效大大的提高，达到或超过了开颅手术的效果。通常把栓塞线圈解脱在脑动脉瘤腔内，从而在腔内造成血栓，达到栓塞动脉瘤的目的。
目前使用的栓塞线圈主要有机械解脱弹簧圈、电热熔解脱弹簧圈和电解脱弹簧圈，其中使用最多的为电解脱弹簧圈，主要有Boston Scientific的GDC和Target弹簧圈。1991年Guglielmi等首次报道GDC电解脱弹簧圈栓塞治疗颅内动脉瘤。GDC远端为铂金的弹簧圈，与不锈钢导丝相连，栓塞线圈材料的设计可以到达迂曲复杂的脑动脉的动脉瘤病变，GDC电解脱弹簧圈填塞瘤腔是经皮血管穿刺，通过微导管导入动脉瘤，栓塞线圈与不锈钢导丝相连部分因电解而溶断，栓塞线圈解脱留于动脉瘤内，从而阻止血流流入动脉瘤。
栓塞线圈颅内动脉瘤中较为关键步骤是微导管准确到位并能固定于瘤腔口，微导管末端保持在瘤腔内靠近瘤颈的1/3～1/2处，较小动脉瘤可放在动脉瘤颈处，这样阻力较小而利于栓塞线圈的缠绕。目前来说，Boston Scientific的GDC和Target弹簧圈、Medtronic(Ev3)公司的Axium弹簧圈、Microvention公司的MicroPlex弹簧圈和HydroCoil弹簧圈的显著问题是弹簧圈和推送杆之间的解脱区域(解脱区域是指栓塞线圈和推送杆相连接处的区域，通过电解而断开的解脱点就位于该区域中。然而解脱区域并不等于解脱点，而是指从所述推送杆远端柔软度突变处开始到弹簧圈近端柔软度突变处终止)相对较长(至少大于1.5mm，有的甚至达到3mm)，而且刚硬(弯曲弹性模量至少大于300Mpa)，例如：GDC弹簧圈的弹簧线圈和推送杆之间设有锚连接弹簧和PET，解脱区域长度为1.6mm；MicroPlex弹簧圈的加热弹簧、支持弹簧、PET 和导电丝使得解脱区域的长度达到3.0mm；Axium弹簧圈的PET、海波管和圆球的咬合的解脱区域长度为2.0mm。这些较长而且较硬的解脱区域很容易导致微导管外踢效应(即，在瘤腔内的微导管末端被解脱完的弹簧圈踢出瘤腔，微导管末端掉入载瘤动脉中)，而目前动脉瘤内平均需填塞5～6个弹簧圈用于治疗，而外踢效应导致微导管移位，势必造成医生需要把微导管重新放置在瘤腔内靠近瘤颈处，这时之前填塞的弹簧圈堵住通道增加医生重新放置微导管的难度，延长手术时间或造成手术失败。
发明人认为现有栓塞线圈的解脱区域长且刚硬的原因是，其推送杆和栓塞线圈之间并不是直接连接，而是通过一个功能模块相连。机械解脱弹簧圈的推送杆和弹簧圈之间隔着一个锚定模块；电热熔解脱弹簧圈的推送杆和弹簧圈之间隔着一个加热模块；另外，现有的电解脱弹簧圈的推送杆和弹簧圈之间隔着一个绝缘模块。
因此，如何改进解脱区域的性能，确保栓塞线圈解脱正常，防止微导管外踢效应，是目前亟待解决的难题。
发明内容
本发明的目的在于，提供一种栓塞线圈输送装置及其制备方法，克服现有技术中微导管容易外踢的问题。
为解决上述技术问题，本发明提供一种栓塞线圈输送装置，包括推送杆和栓塞线圈，所述推送杆的远端和栓塞线圈的近端相连接处为解脱区域，其中，所述栓塞线圈输送装置还包括：
一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈的近端的线圈上；以及一导电丝设置为穿过所述推送杆的内部，所述导电丝上覆有绝缘层，且所述导电丝的远端设有未覆盖绝缘层的解脱点，所述导电丝的远端和所述抗解旋丝的近端交叉连接。
可选的，对于所述的栓塞线圈输送装置，所述抗解旋丝固定在所述栓塞线圈近端的第2～6个线圈的任一个上。
可选的，对于所述的栓塞线圈输送装置，所述解脱区域的弯曲弹性模量为 150～220Mpa。
可选的，对于所述的栓塞线圈输送装置，所述解脱区域的长度为0.3mm～1.0mm。
可选的，对于所述的栓塞线圈输送装置，所述导电丝的远端呈“J”型、“U”型或“T”型，所述抗解旋丝的近端呈“J”型或“U”型，所述导电丝与所述抗解旋丝UU型交叉连接、UJ型交叉连接、JU型交叉连接、JJ型交叉连接、TU型交叉连接或者TJ型交叉连接。
可选的，对于所述的栓塞线圈输送装置，所述导电丝与所述抗解旋丝交叉连接处涂覆有高分子胶水。
可选的，对于所述的栓塞线圈输送装置，所述绝缘层的材料包括聚四氟乙烯、聚对苯二甲酸乙二醇酯、聚醚酰胺和聚酰亚胺中的至少一种。
可选的，对于所述的栓塞线圈输送装置，还包括一解脱器，所述推送杆的近端插入所述解脱器中，所述解脱器用于施加0.5mA～5.0mA的直流电流至所述导电丝。
可选的，对于所述的栓塞线圈输送装置，所述栓塞线圈呈“Ω”状篮筐型或螺旋型。
本发明还提供一种如上所述的栓塞线圈输送装置的制备方法，包括：
提供推送杆和栓塞线圈；
将一抗解旋丝设置在所述栓塞线圈中，且固定在所述栓塞线圈的近端；
将一导电丝穿过所述推送杆中心；在所述导电丝上覆盖绝缘层，并在所述导电丝的远端设置未覆盖绝缘层的解脱点，以及
将所述抗解旋丝的近端与所述导电丝的远端交叉连接。
可选的，对于所述的栓塞线圈输送装置的制备方法，所述抗解旋丝固定在所述栓塞线圈近端的第2～6个线圈的任一个上。
可选的，对于所述的栓塞线圈输送装置的制备方法，所述导电丝的远端呈“J”型、“U”型或“T”型，所述抗解旋丝的近端呈“J”型或“U”型，所述导电丝与所述抗解旋丝UU型交叉连接、UJ型交叉连接、JU型交叉连接、JJ型交叉连接、TU型交叉连接或者TJ型交叉连接。
可选的，所述的栓塞线圈输送装置的制备方法还包括在所述交叉连接处涂覆高分子胶水。
在本发明提供的栓塞线圈输送装置及制备方法中，包括推送杆和栓塞线圈，所述推送杆的远端和栓塞线圈的近端相连接作为解脱区域，一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈的近端，一导电丝设置在所述推送杆中，所述抗解旋丝与所述导电丝相连接。相比现有技术，本发明是将抗解旋丝固定在栓塞线圈近端的线圈上，在所述导电丝上设置绝缘层，并在导电丝的远端设置未覆盖绝缘层的解脱点，所述抗解旋丝与所述导电丝交叉连接，使导电丝和抗解旋丝被缠绕固定在栓塞线圈近端的线圈上，这样的结构降低了解脱区域的长度，且使得解脱区域可以更为柔软，基本上避免了栓塞线圈放置后使得微导管外踢的状况发生，提高了手术成功率。
附图说明
图1为本发明中栓塞线圈输送装置的结构示意图；
图2为图1中解脱区域和栓塞线圈的结构示意图；
图3为本发明一实施例中抗解旋丝与导电丝相连接的示意图；
图4为本发明一实施例中抗解旋丝与导电丝相连接的示意图；
图5为本发明一实施例中抗解旋丝与导电丝相连接的示意图；
图6为本发明一实施例中抗解旋丝与导电丝相连接的示意图；
图7为本发明一实施例中抗解旋丝与导电丝相连接的示意图；
图8为本发明一实施例中栓塞线圈的示意图；
图9为本发明一实施例中栓塞线圈的示意图；
图10为本发明一实施例中解脱区域弯曲弹性模量测试的示意图。
具体实施方式
下面将结合示意图对本发明的栓塞线圈输送装置及其制备方法进行更详细的描述，其中表示了本发明的优选实施例，应该理解本领域技术人员可以修改在此描述的本发明，而仍然实现本发明的有利效果。因此，下列描述应当被理 解为对于本领域技术人员的广泛知道，而并不作为对本发明的限制。
在下列段落中参照附图以举例方式更具体地描述本发明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。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。
本发明提供了一种栓塞线圈输送装置，包括推送杆和栓塞线圈，一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈近端的线圈部分上，一导电丝设置为穿过所述推送杆内部，所述导电丝上覆有绝缘层，并且导电丝的远端设置有未覆盖绝缘层的解脱点，所述抗解旋丝与所述导电丝交叉连接。这样的结构设计省略了导电丝与栓塞线圈之间的中间模块，减小了解脱区域的长度，且使得解脱区域可以更为柔软，基本上避免了栓塞线圈放置后使得微导管外踢的状况发生，提高了手术成功率。
以下列举所述栓塞线圈输送装置的较优实施例，以清楚的说明本发明的内容，应当明确的是，本发明的内容并不限制于以下实施例，其他通过本领域普通技术人员的常规技术手段的改进亦在本发明的思想范围之内。
请参考图1，本发明的栓塞线圈输送装置，包括推送杆106和栓塞线圈107，所述推送杆106的远端和栓塞线圈107的近端相连接处为解脱区域103。所谓的解脱区域是指从所述推送杆远端柔软度突变处开始到栓塞线圈近端柔软度突变处为止的一段区域，其位于推送杆与栓塞线圈的连接处，通过电解而断开的解脱点就位于该区域中。所述栓塞线圈内部设有一抗解旋丝，所述抗解旋丝固定在所述栓塞线圈107的近端，一导电丝104穿过所述推送杆106中心，所述导电丝104上覆有绝缘层，所述绝缘层的材料为聚四氟乙烯(PTFE)、聚对苯二甲酸乙二醇酯(PET)、聚醚酰胺(PEBAX)和聚酰亚胺(Polyimide)中的至少一种。所述抗解旋丝与所述导电丝104交叉连接。
需要说明的是，“远端”和“近端”是每个部件或模块的各自端部的相对概念，例如把靠近操作者的一端定义为“近端”，远离操作者的一端定义为“远端”，这在本领域中为公知常识，此处不进行过多解释。
具体的，请结合图2，所述抗解旋丝108固定在所述栓塞线圈近端1071的 第2～6个线圈中的任一个上。
由此可见，本发明中是抗解旋丝108与所述导电丝104相连接，并不需要二者通过中间转接模块连接，而且抗解旋丝108固定在栓塞线圈107上，也能够实现稳固，不会脱落。这样，可以确保解脱区域的柔软性，并且尽可能的减小解脱区域的长度。能有效避免在瘤腔内的微导管末端被解脱完的栓塞线圈107踢出瘤腔。在一个实施例中，所述解脱区域103的长度为0.3mm～1.0mm。
在本发明中，所述导电丝104的远端和所述抗解旋丝108的近端交叉连接。请参考图3-图7，示出了多种可选方案。
例如，所述导电丝104的远端呈“J”型、“U”型或“T”型，所述抗解旋丝108的近端呈“J”型或“U”型。
如图3所示，采用导电丝104的远端呈“U”型，抗解旋丝108的近端呈“U”型，实现二者UU型交叉连接。
如图4所示，采用导电丝104的远端呈“J”型，抗解旋丝108的近端呈“U”型，实现二者UJ型交叉连接。
如图5所示，采用导电丝104的远端呈“J”型，抗解旋丝108的近端呈“J”型，实现二者JJ型交叉连接。
如图6所示，采用导电丝104的远端呈“T”型，抗解旋丝108的近端呈“J”型，实现二者TJ型交叉连接。
如图7所示，采用导电丝104的远端呈“T”型，抗解旋丝108的近端呈“U”型，实现二者TU型交叉连接。
通过使得所述导电丝104的远端和所述抗解旋丝108的近端交叉连接，可以使栓塞线圈107和推送杆106保持一定的连接强度，同时有效的把力传递到栓塞线圈107上，保证栓塞线圈107的输送。
当然，所述导电丝104和所述抗解旋丝108的连接并不限于本发明中所列举的形式，本领域技术人员可以灵活选择其他可行方式。
在一个实施例中，所述抗解旋丝108与所述导电丝104相连接处涂覆高分子胶水，以增强连接强度。例如，所述高分子胶水可以是UV胶、环氧胶等。
以图3所示为例，在本发明中，所述导电丝104包括涂层区1042(即绝缘 层)和裸露区1041，所述裸露区1041是位于导电丝104的远端的一狭窄区域，在体液中通过电解断开，从而使推送杆106和栓塞线圈107分离，因此也被称为解脱点。
所述涂层区1042的涂层材料包括聚四氟乙烯(PTFE)、聚对苯二甲酸乙二醇酯(PET)、聚醚酰胺(PEBAX)和聚酰亚胺(Polyimide)中的至少一种。
在一个实施例中，所述导电丝104的材质可以是金属，例如生物效能好的金属，诸如不锈钢、金、银、铁等。
请继续参考图1，所述栓塞线圈输送装置还包括一解脱器105，所述推送杆106的近端插入所述解脱器105中，所述解脱器105施加0.5mA～5.0mA的直流电流至所述导电丝104，更具体的，例如1.0mA～3.0mA的电流，从而可以安全快速的使栓塞线圈107和推送杆106分离。所述解脱器105可以是手持式，以便于操作。
请继续参考图1，所述推送杆106包含相连接的金属管状物101和金属弹簧管状物102，金属弹簧管状物102的长度可以为40～50cm，能顺利穿过主动脉弓之上的颅内迂曲血管。相应的，所述金属弹簧管状物102的远端1021即为所述推送杆106的远端；而金属管状物101的近端则可以插入所述解脱器105中。
当栓塞线圈107通过导入鞘管和配用的微导管(图中未示出)时呈近似伸直状态，通过推送杆106将栓塞线圈107输送到病变部位。当栓塞线圈107由微导管进入到病变部位后，恢复其二级形态并顺应病变部位的形状，通过在体外的解脱器105可以将栓塞线圈107从推送杆远端解脱分离，完成植入。
请参考图8和图9，所述栓塞线圈107的二级形态呈“Ω”状篮筐型或螺旋型。当然，依据不同需求，可以设置其他形状的栓塞线圈107，以适应不同尺寸的瘤体。
本发明还提供一种栓塞线圈输送装置的制备方法，包括：
提供推送杆和栓塞线圈；
将一抗解旋丝设置在所述栓塞线圈中，且固定在所述栓塞线圈的近端的线圈上；
将一导电丝设置在所述推送杆中，在所述导电丝上设置绝缘层以及远端的 未覆盖绝缘层的解脱点；以及
将所述抗解旋丝与所述导电丝相连接，以使得所述推送杆的远端和栓塞线圈的近端相连接作为解脱区域。
在一个实施例中，所述抗解旋丝固定在所述栓塞线圈的第2～6个线圈的任一个上。
在一个实施例中，将所述抗解旋丝与所述导电丝相连接之后，还包括：在所述抗解旋丝与所述导电丝相连接处涂覆高分子胶水，以增强连接强度。
其中，栓塞线圈可以为铂合金丝绕制而成，铂合金线圈可以有不同的长度和直径。例如，可以是铂合金丝链绕在芯棒上制成初级线圈；然后将绕制好的初级线圈按照预先设定好的形状在模具上绕制并进行定型处理，例如获得二级形态为“Ω”状篮筐型或螺旋型结构。
在一个实施例中，铂合金线圈由直径0.003英寸的丝链制成，在金属芯棒上绕制成紧密初级线圈，这些初级线圈作为栓塞线圈107，将绕制好的初级线圈按照预先设定好的“Ω”状篮筐型的二级形态绕制并进行定型处理，即获得的栓塞线圈107的二级形态为“Ω”状篮筐型。
将导电丝104远端制作成“U”型(如图3所示)；将抗解旋丝108在栓塞线圈107的内部沿初级线圈轴向延伸(见图2中的部分剖视图所示)，并且抗解旋丝108与导电丝104的“U”型远端交叉连接后形成U型近端(如图3所示)，抗解旋丝108近端“U”的一边固定缠绕在栓塞线圈107近端的第2个至第6个线圈的任一线圈(如图2所示)，另一边返回到栓塞线圈107的远端，并可选的在栓塞线圈107的远端制成球帽，从而将其固定。在所述导电丝104上设置绝缘层1042，并在其远端设置未覆盖绝缘层的解脱点1041(如图3所示)，在导电丝104与抗解旋丝108的交叉连接区域形成解脱区域103，所述解脱区域103的长度为0.5mm。依据图10所示三点弯曲法获得解脱区域103的弯曲弹性模量为150Mpa。
图10所示的三点弯曲法可以是，在导电丝104与抗解旋丝108交叉连接形成解脱区域103后，将金属弹簧管状物102与栓塞线圈107分别由固定装置200夹持住，然后在解脱区域103施加一定的力，例如下压10mm，即可算得弯曲弹 性模量。
在一个实施例中，栓塞线圈107的结构制成螺旋型(如图9所示)，铂合金线圈由直径是0.00125英寸的丝链制成，同样的，是在金属芯棒上绕制成紧密初级线圈，将绕制好的初级线圈按照预先设定好的形状“螺旋型”进行定型处理。
将导电丝104远端制作成“J”型(如图4所示)；将抗解旋丝108沿初级线圈轴向延伸，并且抗解旋丝108与导电丝104的“J”型远端交叉连接后形成U型近端(如图4所示)，抗解旋丝108近端“U”的一边固定缠绕在栓塞线圈107近端的第2个至第6个线圈的任一线圈(如图2所示)，另一边返回到栓塞线圈107的远端。在所述导电丝上设置绝缘层，并在导电丝的远端设置未覆盖绝缘层的解脱点，由导电丝104与抗解旋丝108的交叉连接区域形成解脱区域103，所述解脱区域103的长度为1.0mm。依据图10所示三点弯曲法获得解脱区域103的弯曲弹性模量为210Mpa。
在一个实施例中，栓塞线圈107的结构制成螺旋型(如图9所示)，铂合金线圈由直径是0.002英寸的丝链制成，同样的，是在金属芯棒上绕制成紧密初级线圈，将绕制好的初级线圈按照预先设定好的形状“螺旋型”进行定型处理。
将导电丝104远端制作成“J”型(如图5所示)；将抗解旋丝108沿初级线圈轴向延伸，并且抗解旋丝108与导电丝104的“J”型远端交叉连接后形成“J”型近端(如图5所示)，抗解旋丝108近端“J”的一边固定缠绕在栓塞线圈107近端的第3个线圈。在所述导电丝上设置绝缘层，并在导电丝的远端设置未覆盖绝缘层的解脱点，由导电丝104与抗解旋丝108的交叉连接区域形成解脱区域103，所述解脱区域103的长度为0.5mm。依据图10所示三点弯曲法获得解脱区域103的弯曲弹性模量为150Mpa。
在一个实施例中，将导电丝104远端设计为“T”型(如图6和图7所示)；将抗解旋丝108沿初级线圈轴向延伸，并且抗解旋丝108的近端设计为“J”型(如图6所示)或“U”型(如图7所示)；在所述导电丝上设置绝缘层，并在导电丝的远端设置未覆盖绝缘层的解脱点，并且将导电丝104与抗解旋丝108交叉连接。
对于图4至7所示的交叉连接方式，优选的，在所述抗解旋丝108与所述 导电丝104的交叉连接处涂覆高分子胶水，以增强连接强度。
经由上文描述可知，在本发明提供的栓塞线圈输送装置及制备方法中，包括推送杆和栓塞线圈，所述推送杆的远端和栓塞线圈的近端相连接作为解脱区域，一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈的近端，一导电丝设置在所述推送杆中，所述导电丝上设置有绝缘层，并且导电丝的远端设置有未覆盖绝缘层的解脱点，所述抗解旋丝与所述导电丝相连接。相比现有技术，本发明是将抗解旋丝固定在栓塞线圈的近端，从而所述抗解旋丝与所述导电丝相连接，因此降低了解脱区域的长度，且使得解脱区域可以更为柔软，基本上避免了栓塞线圈放置后使得微导管外踢的状况发生，提高了手术成功率。
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 (13)

  1. 一种栓塞线圈输送装置，其特征在于，包括推送杆和栓塞线圈，所述推送杆的远端和栓塞线圈的近端相连接处为解脱区域，
    其中，所述栓塞线圈输送装置还包括：一抗解旋丝设置在所述栓塞线圈中，所述抗解旋丝固定在所述栓塞线圈的近端的线圈上；以及一导电丝设置为穿过所述推送杆的内部，所述导电丝上覆有绝缘层，且所述导电丝的远端设有未覆盖绝缘层的解脱点，所述导电丝的远端和所述抗解旋丝的近端交叉连接。
  2. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述抗解旋丝固定在所述栓塞线圈近端的第2～6个线圈的任一个上。
  3. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述解脱区域的弯曲弹性模量为150～220Mpa。
  4. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述解脱区域的长度为0.3mm～1.0mm。
  5. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述导电丝的远端呈“J”型、“U”型或“T”型，所述抗解旋丝的近端呈“J”型或“U”型，所述导电丝与所述抗解旋丝UU型交叉连接、UJ型交叉连接、JU型交叉连接、JJ型交叉连接、TU型交叉连接或者TJ型交叉连接。
  6. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述导电丝与所述抗解旋丝交叉连接处涂覆有高分子胶水。
  7. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述绝缘层的材料包括聚四氟乙烯、聚对苯二甲酸乙二醇酯、聚醚酰胺和聚酰亚胺中的至少一种。
  8. 如权利要求1所述的栓塞线圈输送装置，其特征在于，还包括一解脱器，所述推送杆的近端插入所述解脱器中，所述解脱器用于施加0.5mA～5.0mA的直流电流至所述导电丝。
  9. 如权利要求1所述的栓塞线圈输送装置，其特征在于，所述栓塞线圈呈“Ω”状篮筐型或螺旋型。
  10. 一种如权利要求1所述的栓塞线圈输送装置的制备方法，其特征在于， 包括：
    提供推送杆和栓塞线圈；
    将一抗解旋丝设置在所述栓塞线圈中，且固定在所述栓塞线圈的近端；
    将一导电丝穿过所述推送杆中心；在所述导电丝上覆盖绝缘层，并在所述导电丝的远端设置未覆盖绝缘层的解脱点，以及
    将所述抗解旋丝的近端与所述导电丝的远端交叉连接。
  11. 如权利要求10所述的栓塞线圈输送装置的制备方法，其特征在于，所述抗解旋丝固定在所述栓塞线圈近端的第2～6个线圈的任一个上。
  12. 如权利要求10所述的栓塞线圈输送装置的制备方法，其特征在于，所述导电丝的远端呈“J”型、“U”型或“T”型，所述抗解旋丝的近端呈“J”型或“U”型，所述导电丝与所述抗解旋丝UU型交叉连接、UJ型交叉连接、JU型交叉连接、JJ型交叉连接、TU型交叉连接或者TJ型交叉连接。
  13. 如权利要求10所述的栓塞线圈输送装置的制备方法，其特征在于，还包括在所述交叉连接处涂覆高分子胶水。
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* Cited by examiner, † Cited by third party
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US10857012B2 (en) 2015-01-20 2020-12-08 Neurogami Medical, Inc. Vascular implant
US10925611B2 (en) 2015-01-20 2021-02-23 Neurogami Medical, Inc. Packaging for surgical implant
US11006940B2 (en) 2015-01-20 2021-05-18 Neurogami Medical, Inc. Micrograft for the treatment of intracranial aneurysms and method for use
US11096679B2 (en) 2015-01-20 2021-08-24 Neurogami Medical, Inc. Micrograft for the treatment of intracranial aneurysms and method for use
US11241223B2 (en) 2015-01-20 2022-02-08 Neurogami Medical, Inc. Micrograft for the treatment of intracranial aneurysms and method for use
US11484319B2 (en) 2015-01-20 2022-11-01 Neurogami Medical, Inc. Delivery system for micrograft for treating intracranial aneurysms
US11627950B2 (en) 2015-01-20 2023-04-18 Neurogami Medical, Inc. Micrograft for the treatment of intracranial aneurysms and method for use
US11779452B2 (en) 2015-01-20 2023-10-10 Neurogami Medical, Inc. Vascular implant
US11786255B2 (en) 2015-01-20 2023-10-17 Neurogami Medical, Inc Packaging for surgical implant
CN115363664A (zh) * 2020-12-29 2022-11-22 聚辉医疗科技(深圳)有限公司 栓塞弹簧圈系统

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KR20200044843A (ko) 2020-04-29
US11172934B2 (en) 2021-11-16
KR102365255B1 (ko) 2022-02-23
EP3669799B1 (en) 2022-11-23
EP3669799A1 (en) 2020-06-24
EP3669799A4 (en) 2020-08-05
JP2020530802A (ja) 2020-10-29
PH12020500348A1 (en) 2021-01-25
US20200281598A1 (en) 2020-09-10
CN107374690A (zh) 2017-11-24
ES2937238T3 (es) 2023-03-27
BR112020003021A2 (pt) 2020-07-28
JP7026779B2 (ja) 2022-02-28

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