WO2021128937A1 - 支架输送系统及装载支架的方法 - Google Patents

支架输送系统及装载支架的方法 Download PDF

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Publication number
WO2021128937A1
WO2021128937A1 PCT/CN2020/113612 CN2020113612W WO2021128937A1 WO 2021128937 A1 WO2021128937 A1 WO 2021128937A1 CN 2020113612 W CN2020113612 W CN 2020113612W WO 2021128937 A1 WO2021128937 A1 WO 2021128937A1
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WO
WIPO (PCT)
Prior art keywords
stent
rear release
release
wire
delivery system
Prior art date
Application number
PCT/CN2020/113612
Other languages
English (en)
French (fr)
Inventor
彭大冬
屠春霖
邓筱娟
袁振宇
朱清
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Priority to KR1020227025629A priority Critical patent/KR20220121851A/ko
Priority to EP20907496.2A priority patent/EP4082490A4/en
Priority to BR112022012544A priority patent/BR112022012544A2/pt
Priority to US17/787,120 priority patent/US20230018528A1/en
Priority to JP2022538900A priority patent/JP2023509865A/ja
Publication of WO2021128937A1 publication Critical patent/WO2021128937A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the invention relates to the technical field of medical devices, and in particular to a stent delivery system and a method for loading a stent.
  • Thoracic aortic aneurysm or dissection is a fatal vascular surgical disease, and its incidence is not low.
  • traditional surgical treatments had been used in medicine to treat thoracic aortic aneurysms or dissections.
  • this treatment had the disadvantages of difficult surgery, large trauma, and many complications.
  • Dake et al. used endovascular stent graft implantation for aortic dissection for the first time, and subsequent interventional surgery has been greatly developed.
  • Interventional surgery generally involves the delivery of the stent graft through the outer sheath into the body through femoral artery puncture, and along with the passage of the aorta to the location of the diseased aorta, covering and repairing the diseased blood vessel.
  • the covered stent refers to an artificial intracorporeal graft in which the inner or outer surface of the stent body is partially or completely covered with a membranous material.
  • the principle of the treatment of dissection with stent graft is to deliver the stent graft into the diseased site through a special delivery system and then release and expand.
  • the membranous material on the stent graft will isolate the rupture of the aortic dissection and block blood from continuing to flow into the dissection.
  • the false cavity avoids further tearing or even rupture of the dissection, while the stent body of the stent graft plays a role in supporting the blood vessel wall, preventing blood from flowing into the false cavity and compressing the true cavity, which affects the flow of blood and tissues and organs. Blood supply. Sealing the rupture often requires a healthy blood vessel at the proximal end of the stent graft as the stent anchoring area.
  • the rupture is often very close to important branch blood vessels, so the stent anchoring area is often short, limited, and precious.
  • the stent will often move backward due to the impact of blood flow or jump forward due to system design problems, and other problems such as inaccurate stent release positioning, which causes the branch blood vessels including the stent anchoring area to be completely blocked.
  • the undesirable phenomenon of incomplete closure of the rupture After the branch blood vessel is completely blocked, it will cause organ ischemia or cerebral ischemia and other adverse consequences that affect the health of the patient, while incomplete closure of the rupture will cause endoleak and affect the health of the patient. The undesirable consequences.
  • the purpose of the present invention is to provide a stent delivery system and a method for loading a stent, which can avoid the problem of the stent moving backward due to the impact of blood flow, and improve the accuracy of stent release and positioning.
  • the present invention provides a stent delivery system, including: a handle, an outer tube, a restraint device and a rear release device;
  • the outer tube has an axially extending inner cavity for accommodating the compressed stent, and is retracted proximally under the control of the handle to expose the stent;
  • the restraint device includes at least one restraint wire and a control guide wire, the restraint wire is configured to be arranged around the circumference of the stent, and the control guide wire is used to control the restraint wire to form an open loop or a closed loop structure to Compress or release the stent;
  • the rear release device is arranged in the outer tube and is configured to be detachably connected to the proximal end of the stent for restraining or releasing the proximal end of the stent.
  • the restraint device includes at least two restraint wires, and at least two restraint wires are configured to be spaced apart along the axial direction of the main body portion.
  • the binding wire is a double-strand binding wire with closed ends, and the double-strand binding wire is configured to pass through the tail end of the double-strand binding wire after at least one week around the stent.
  • the control guide wire is configured to pass through the head end of the double-strand tie wire, so that the double-strand tie wire forms a closed loop structure; or, the double-strand tie wire is configured to surround the stent For at least one week, the control guide wire is configured to pass through the head end and the tail end of the double-strand binding wire, so that the double-strand binding wire forms a closed loop structure.
  • a fixed coil is provided on the bracket, and the binding wire is configured to pass through the fixed coil.
  • the bracket is provided with a plurality of fixed coils, at least two of the fixed coils are arranged at intervals around the circumference of the bracket, and the binding wire is configured to be separated from the at least two of the fixed coils.
  • the delivery system further includes an inner tube, the inner tube is arranged in the outer tube, a gap is provided between the outer tube and the inner tube for accommodating the stent, and the rear release device There is a passage for the inner tube to pass through.
  • the rear release device includes a tapered head, a rear release fixing member, a rear release rear end, a plurality of rear release screw rods and a rear release guide wire, and the distal end of the tapered head is provided with the rear release guide wire.
  • a plurality of fixing holes matched with the screw rod, and a plurality of guide holes matching the rear release screw rod are provided in the rear release fixing member, and the distal ends of the plurality of rear release screw rods are all connected with the rear release screw rods.
  • the rear ends are fixedly connected, and the proximal ends of the plurality of rear release screw rods respectively pass through the corresponding guide holes in the rear release fixing member and are inserted into the corresponding fixing holes on the tapered head.
  • the proximal end of the release guide wire is fixedly connected with the rear release rear end, and the rod section of the rear release screw rod between the tapered head and the rear release fixing member is used to pass through and bind the stent The near end.
  • the tapered head, the rear release fixing member and the rear release rear end are all provided with a passage for the inner tube to pass through, and one end of the inner tube is connected to the tapered head , And pass through these passages in turn.
  • a stop block is provided on a pipe section of the inner tube on the distal side of the rear release rear end, and the outer diameter of the stop block is larger than the diameter of the passage in the rear release rear end.
  • the present invention also provides a method for loading a bracket, including:
  • the compressed stent together with the inner tube of the delivery system and the rear release device are pressed into the inner cavity of the outer tube of the delivery system, and the distal end of the outer tube is fixedly connected with a handle.
  • the stent delivery system of the present invention includes a handle, an outer tube, a restraint device, and a rear release device.
  • the structure is simple and convenient to use.
  • the rear release device can be assembled with the proximal end of the stent (that is, the end close to the diseased location) and pass The restraint device restrains the stent in the restrained state, and then presses it into the outer tube. After that, the stent can be transported to the diseased location through the outer tube and the handle for release.
  • the stent When the stent is released by the restraint device, its proximal end is
  • the rear release device is always fixed, thereby avoiding the problem of backward movement of the stent caused by blood impact, and improving the positioning accuracy of the stent release.
  • the restraint device is controlled by the control guide wire to open and close.
  • the stent can be gradually released from near and far to the expanded state as the control guide wire is withdrawn. This can realize the stable release of the stent and ensure the accuracy of the position of the stent.
  • the distal end of the stent can be fixed to the inner tube by the fixing coil, and the proximal end of the stent can be kept fixed on the rear release device, thereby avoiding the stent during the middle release of the stent.
  • the front jump and shortening problems of the stent truly realize the precise control and release of the bracket.
  • FIG. 1 is a schematic structural diagram of a restraint bracket of a restraint device according to a specific embodiment of the present invention
  • FIG. 2 is a schematic diagram of the structure of the restraint bracket of the restraint device according to the specific embodiment of the present invention.
  • Fig. 3 is a schematic structural diagram of a rear release device in a specific embodiment of the present invention that cooperates with the proximal end of the stent;
  • Figure 4 is a schematic structural diagram of a rear-release rear end of a specific embodiment of the present invention.
  • 5 to 8 are schematic diagrams of the structure in a method of delivering a stent through a stent delivery system according to a specific embodiment of the present invention
  • proximal end refers to the end of the medical device that is close to the installation location (such as the heart, vascular lesions, etc.) during normal operation, that is, the front end of the stent delivery system, that is, the end far away from the operator.
  • distal usually refers to the end of the medical device away from the installation position, that is, the end close to the operator, that is, the end close to the handle.
  • an embodiment of the present invention provides a stent delivery system, including: a handle, an outer tube 52, a restraining device, and a rear release device 4.
  • the outer tube 52 has an axially extending inner cavity for accommodating the compressed stent 1, and under the control of the handle, it withdraws to the distal end of the stent 1 to The stent 1 is exposed.
  • the stent delivery system of this embodiment further includes an inner tube 51, the inner tube 51 is arranged in the outer tube 52, the outer tube 52 and the inner tube 51 are sleeved together with a The gap is used to accommodate the stent 1, and the rear release device 4 is provided with a passage for the inner tube 51 to pass through, and the proximal end of the inner tube 51 and the proximal end of the rear release device 4 are fixedly connected together.
  • the stent 1 can be sleeved on the inner tube 51, and the proximal end is assembled on the rear release device 4, and the rest is compressed by the restraint device.
  • the assembled stent 1, restraint device and the distal end and middle section of the rear release device 4 are together It is movably placed in the gap between the outer tube 52 and the inner tube 51.
  • the stent 1 that can be delivered by the stent delivery system may be a stent graft, or a non-graft stent or a bare stent.
  • the bare stent is usually a lumen structure made of stainless steel and/or a memory metal material, which can be sleeved on the inner tube 51 with no polymer coating material on its surface.
  • a structure of a bare stent is, for example, a lumen structure formed by alternately connecting an annular Z-shaped stent ring and a metal mesh stent, or, for example, a lumen structure formed by a metal mesh.
  • the difference between the stent graft and the bare stent is that the metal stent body is covered with a film, which can fully cover the outer or inner surface of the metal stent body, or it can only cover the middle section of the metal stent body. It can cover the middle section and the distal end of the metal stent body, or even discontinuously cover multiple positions in the middle section of the metal stent body.
  • the covering film also has a lumen structure as a whole and can be sleeved on the inner tube 51. The stent graft can also easily switch between the bent state and the straight state.
  • the stent graft When the stent graft is implanted into the blood vessel, the stent graft can be compressed to the straight state to facilitate implantation; After the position of the blood vessel, the stent graft can be restored to a curved state that matches the blood vessel at the diseased location, thereby avoiding complications caused by the resilience of the stent graft acting on the local blood vessel wall.
  • the stent graft usually includes a metal stent body and a film covering the inner or outer surface of the metal stent body.
  • the metal stent body may be a hollow elastic structure made of metal materials such as stainless steel or memory metal materials.
  • the metal stent body can be a metal mesh woven with metal wires, and can be a structure composed of a plurality of ring-shaped Z-shaped wave stent rings and a plurality of stent spine bones fixedly connected to these ring-shaped Z-shaped wave stent rings, or It is a structure composed of multiple stent spine and its fixedly connected annular Z-shaped wave stent ring and metal grid.
  • the stent 1 is a stent graft, which is mainly composed of a metal stent body and a membrane covering the surface of the metal stent body.
  • the distal end 12 of the lesion location and the middle section 11 connected between the proximal end 10 and the distal end 12, the proximal end of the stent 1 is a bare stent section without covering, the middle section 11 of the stent 1 and the metal stent body of the distal end 12
  • the outer surface is covered by a film.
  • the metal stent body of the stent 1 is made of a memory metal material.
  • the memory metal material has a memory effect, such as NiTi alloy, which can solve the problem of deformation that does not meet requirements when made with other materials.
  • the covering film of the stent 1 is made of a polymer material, for example, polyester material (PET), polytetrafluoroethylene (PTFE), nylon, polyester, polypropylene, etc., and the covering film It can be stitched on the metal stent body by using polyester sutures, or it can be formed on the metal stent body by a compression molding process.
  • the covering film is preferably provided with a development mark for development, and the development mark is, for example, platinum.
  • the iridium alloy developing point enables the user to dynamically monitor the position of the stent 1 through the developing device during the introduction and release of the stent 1, and then adjust the stent 1 to the optimal position to achieve the purpose of precise positioning and release.
  • the bare stent section 10 is the proximal end of the stent, which is used to increase the anchoring force between the stent 1 and the blood vessel wall, and it may include at least one wave ring that is not covered by a membrane.
  • the wave-shaped ring can be braided by metal wires or cut into the desired wave by a metal tube, it can also include multiple metal wires distributed in the shape of claws, or it can be a metal mesh.
  • a barrier layer with biocompatibility is formed on the bare stent section 10, and the barrier layer is preferably a polytetrafluoroethylene layer.
  • the polytetrafluoroethylene layer can be formed in the following ways: one is to use a long strip of polytetrafluoroethylene film wound on the surface of the metal wire or metal tube used to form the bare stent section 10. The other is to spray liquid polytetrafluoroethylene on the surface of the bare stent section 10 by spraying.
  • the barrier layer can prevent thrombosis on the surface of the bare stent section, inhibit the release of divalent nickel ions, and protect the bare stent.
  • Section 10 is not intended to be corroded by chloride plasma in the receptor fluid, and has good anti-thrombotic, corrosion resistance, and prevention of the dissolution of metal toxic ions.
  • the bare stent section 10 may have a straight cylindrical shape, a trumpet shape that gradually thickens from near to far, or a cone shape that gradually thickens from near to far.
  • the bare stent section 10 can be fixed to the covering film of the stent 1 by connecting multiple points, or it can be connected to the metal stent body area covered by the covering film by integral molding or welding.
  • the restraint device is assembled to the middle section 11 and the distal end 12 of the stent 1 and can be opened and closed relative to the middle section 11 and the distal end 12 of the stent 1, and the stent 1 is closed when closed.
  • the middle section 11 and the distal end 12 are bound to a restrained state, and the middle section 11 and the distal end 12 of the stent 1 are released to an expanded state when opened.
  • the restraint device includes at least one restraint wire 21 and a control guide wire 22, the restraint wire 21 is configured to be arranged around the circumference of the stent 1, and the control guide wire 22 is used to control the restraint wire 21 to form an open A loop or closed loop structure to compress or release the stent 1.
  • the restraint device includes at least two restraint wires 21, and all restraint wires 21 are along the axis of the metal bracket body of the bracket 1 (that is, the main body portion of the bracket 1).
  • the stent 1 can be set at intervals to constrain the diameter of the stent 1 to the target diameter under the control of the control guide wire 22. And there is a gap between the adjacent binding wires 21 (ie a section of the stent 1 without binding wires wrapped), which can avoid the binding wires 21 and the binding wires 21 and the control guide wires 22 and the binding wires 21 from being entangled and knotted. The problem.
  • the material of the restraint thread 21 is a material that can be absorbed by the human body, and is subsequently degraded and absorbed by the human body.
  • each of the binding wires 21 is a double-strand binding wire with closed ends, and the double-strand binding wire is configured such that the head end of the double-strand binding wire is configured to surround the stent 1 for at least one week.
  • the control guide wire 22 is configured to pass through the head end 211 of the double-strand binding wire, so that the double-strand binding wire forms a closed loop structure; or, the double-strand binding wire forms a closed loop structure; or
  • the strand tether wire is configured to surround the stent for at least one week, and the control guide wire 22 is configured to pass through the head end 211 and the tail end 212 of the double strand tether wire, so that the double strand tether wire is formed Closed loop structure.
  • the diameter of the stent 1 after the binding wires 21 are bound may be the same or different.
  • control guide wire 22 can be retracted to the distal end of the stent 1 to gradually change the binding wires 21 into an open-loop structure from near and far, so that the stent 1 is expanded and expanded to realize the stent 1’s release.
  • each binding wire 21 may be a single binding wire, which can bind the stent 1 to the restrained state after being wound on the corresponding position of the stent 1 for at least one week.
  • the tail end and the head end of the binding wire 21 are knotted on the control guide wire 22 to form an open loop or closed loop structure under the control of the control guide wire 22 to compress or release the stent 1.
  • the bracket 1 is provided with a fixing member 31.
  • the fixing member 31 is, for example, an anchor hook or a fixing ring extending from the metal bracket body of the bracket 1.
  • the tail end of the binding wire 21 can pass through the bracket 1
  • the fixing member 31 is fixed to prevent the open-loop or closed-loop structure formed by the binding wire 21 from moving, and on the one hand, it can be beneficial to control the control of the guide wire 22 on the head and tail ends of the binding wire 21, and on the other hand, it can further avoid the binding wire 21.
  • the binding wire 21 and the control guide wire 22 and the binding wire 21 are entangled and knotted with each other.
  • the distal end 12 of the stent 1 is further provided with at least one fixed coil 32, and each of the binding wires 21 is configured to pass through the corresponding fixed coil 32.
  • the distal end of each fixed coil may be fixed on the distal end of the inner tube 51.
  • these fixed coils 32 are preferably evenly arranged around the distal end 12 of the stent 1, so that the distal end 12 of the stent 1 is evenly stressed and prevents the stent 1 from rotating due to uneven forces. And other issues.
  • control wire 22 can pass through the proximal end of a part of the fixed coils 32, and the proximal end of the other part of the fixed coil 32 is passed through by the corresponding binding wire 21.
  • the fixed coils 32 through which the control guide wire 22 can pass can be freely evacuated, and the fixed coils 32 whose proximal ends are passed through by the corresponding binding wires 21 will also be expanded by the stent 1
  • the elastic expansion, together with the binding wire 21 on the distal end 12 of the stent 1 realizes the release of the distal end 12 of the stent 1, and because these proximal ends are passed through by the binding wire 21, the distal end of the fixing coil 32 is still fixed to the inner tube Therefore, the position of the distal end 12 of the stent 1 can be kept unchanged before and after the distal end 12 of the stent 1 is released, which solves the problems of shortening and displacement of the stent 1 during the release and springing process.
  • the rear release device 4 of this embodiment is used to restrain and release the proximal end (ie bare stent section) of the stent 1, and the rear release device 4 has a moving part sleeved on the inner tube 51 And the parts fixed on the inner tube 51.
  • the rear release device 4 includes a tapered head 41, a rear release fixing member 42, a rear release rear end 44, a plurality of rear release screw rods 43 and a rear release guide wire 46.
  • the tapered head 41 is fixedly arranged on the proximal end of the inner tube 51, and the proximal end of the tapered head 41, that is, the end with a smaller diameter is used as a guide for the forward end of the delivery system,
  • the resistance of the delivery system equipped with the stent in the human blood vessel can be reduced, and the delivery is convenient.
  • the distal end of the tapered head 41 that is, the end with a larger diameter and closer to the operation of the operator, is provided with The rear release screw 43 is matched with a plurality of fixing holes 410, and the rear release fixing member 42 is provided with a plurality of guide holes 421 matching the rear release screw 43, and the plurality of rear release screws
  • the distal ends of 43 are fixedly connected to the rear release rear end 44, and the proximal ends of the plurality of rear release screw rods 43 respectively pass through the corresponding guide holes 421 in the rear release fixing member 42 and are inserted into the In the corresponding fixing hole 410 on the tapered head 41, the proximal end of the rear release guide wire 46 is fixedly connected to the rear release rear end 44, and the rear release screw 43 is located between the tapered head 41 and
  • the rod section between the rear release fixing members 42 is used to pass through and bind the bare stent section 10 at the proximal end of the stent graft 1.
  • the guide holes 4 is matched
  • the bare stent section 10 at its proximal end is respectively hung on each rear release rod 43, and then the rear release rear end 44 is pushed to the limit position toward the tapered head 41, and the rear release wire
  • the rod 43 is inserted into the fixing hole 410 at the corresponding end of the tapered head 41 along the guide hole 421 in the rear release fixing member 42, thereby realizing the use of the tapered head 41 and the rear releasing fixing member 42 to clamp the rear release screw 43 and provide Fix the bare stent section 10; when releasing the stent graft 1, pull the handle and release the guide wire 46, so that the rear release screw 43 is separated from the fixing hole 410 in the tapered head 41, and the proximal end of the stent graft 1 is realized With the release of the bare stent section 10, the bare stent section 10 expands due to its own elasticity, so as to fix the stent graft 1 in close contact with the blood vessel.
  • the rear release device 4 of this embodiment can restrain and release the proximal end of the stent 1 through several rear release screw rods 43, and effectively restrain the proximal end of the stent 1 through the subsequent release fixing member 42. It also increases the reliability of the axial movement of the rear release screw 43, and because the contact area between the rear release screw 43 and the fixing hole 410 is small, the resistance received when the stent 1 is released is small, which can improve the entire release process. Accuracy.
  • the tapered head 41, the rear release fixing member 42 and the rear release rear end 44 are all provided with a passage for the inner tube 51 to pass through, and the proximal end of the inner tube 51 and the cone The distal ends of the shaped head 41 are connected and pass through these passages in turn.
  • the inner tube 51 is provided with a stop block 45 on a pipe section located on the distal side of the rear release rear end 44, and the outer diameter of the stop block 45 is larger than the diameter of the passage 441 in the rear release rear end 44 , So as to limit the displacement of the rear-release rear end 44 when the bare stent section 10 is released (that is, limit the extreme position of the distal end movement of the rear-release rear end 44), so as not to make it move excessively and touch the nearby blood vessel.
  • the stop block 45 can make the rear release rear end 44 move to the limit position to stop, so as to avoid The rear release screw 43 is completely released from the rear release fixing member 42.
  • the rear release screw 43 may be made of metal materials such as stainless steel or nickel-titanium alloy, and the axial length of the area between the rear release fixing member 42 and the tapered head 41 meets the installation and release requirements. In this case, it needs to be short enough to increase the rigidity of the rear release screw 43 in this area, and reduce the deformation of the rear release screw 43 due to the expansion force of the stent graft 1.
  • the passage 441 in the rear release rear end 44 is set at the center thereof, and the passage 441 is evenly distributed around the passage 441 for fixing the plurality of rear release rods 43 with the passage 441 as the center.
  • the number of the first small holes 442 is, for example, six. All the first small holes 442 are arranged around the passage 441 at equal angular intervals in the circumferential direction, and then the number of the screw rods 43 is released The number of the first small holes 442 is the same, and the rear release screw 43 is fixed in each of the first small holes 442 in a one-to-one correspondence.
  • At least one second small hole 443 for fixing the rear release guide wire 46 is also provided around the passage 441 in the rear release rear end 44, and the number of the second small holes 443 is the same as the number of the rear release guide wire 46 ,
  • One end of each rear release guide wire 46 penetrates from the distal end of the rear release rear end 44 and passes through the second small hole 443 in a one-to-one correspondence to the proximal end of the rear release rear end 44 , And pass back through the other second small hole 443, the rear release guide wire 46 is fixed in the second small hole 443, and the fixing method is not limited to welding, glue bonding, mechanical locking, etc. .
  • An embodiment of the present invention also provides a method for loading, transporting and releasing a stent.
  • the stent 1 as a stent graft (hereinafter all referred to as stent graft 1) as an example, the method includes the following processes:
  • the steps of assembling the stent graft 1 are divided into three steps: (1) The proximal end of the stent graft 1 is fixed by the rear release device. Specifically, the rear release device 4 and the inner tube 51 are assembled together in advance. At this time, each rear release screw 43 is inserted into the guide hole 421 of the rear release fixing member 42 one by one, and the stent graft 1 is sheathed On the inner tube 51 and move the stent graft 1 along the inner tube 51 until the proximal end of the stent graft 1 moves to the proximal end of the rear release device 4, the proximal end of the stent graft 1 (ie bare stent section) 10 Insert the rear release screw rod 43, and then push the rear release guide wire 46 of the rear release device 4, so that the rear release rear end 44 of the rear release device 4 moves along the inner tube 51 toward the tapered head 41, and the rear release screw 43 is at Driven by the rear release rear end 44 and guided by the guide hole
  • the stent graft 1 is bound by a binding wire 21.
  • the binding wire 21 is used to suture and wrap the stent graft 1 to surround the circumference of the stent, and control the control of the guide wire 22
  • a plurality of closed-loop structures ie, binding coils
  • these closed-loop structures can bind the middle section 11 and the distal end 12 of the stent 1 to the inner tube 51 in a restrained state.
  • the restraint wire 21 is a double closed at both ends.
  • the head end 211 of the double strand binding wire 21 passes through the tail end 212 after at least one week around the stent, and the control guide wire 22 passes through the head end 211 of the double strand binding wire , So that the double-strand binding wire forms a closed loop structure.
  • the rear release device 4 fixes the proximal end of the stent graft 1, and the binding wire and the control guide wire 22 fix the middle section 11 and the distal end 12 of the stent graft 1 (3)
  • the stent graft 1 is crimped in the outer tube 52.
  • the assembled rear release device 4, restraint device, stent graft 1, and inner tube 51 are compressed together to the smallest diameter to be loaded into the inner cavity of the outer tube 52, and the outer tube 52 will follow the inner tube. 51 moves until the proximal end of the outer tube 52 moves to the proximal end of the tapered head 41, so that the outer tube 52 completely surrounds the stent graft 1 and further fixes the distal end of the outer tube 52 to a On the handle.
  • the steps of delivering and releasing the stent graft 1 correspond exactly to the three steps of installing the stent graft 1, and are also divided into three steps: (1) The outer tube 52 guides the stent graft 1 to the lesion position (or called For the initial positioning near the designated location), the outer tube 52 is withdrawn.
  • the blood vessel 7 corresponding to the head end of a positioning guide wire 6 is penetrated to the vicinity of the vascular disease position (or designated position, such as aortic dissection) through the puncture technique;
  • the inner tube 51 and the outer tube 52 that are sheathed together along the positioning guide wire 6 and loaded with the stent 1 in the gap between the two are fed into the blood vessel 7 until the proximal end of the outer tube 52 reaches Near the lesion position of the blood vessel 7, since the proximal end (ie bare stent section) 10 and the distal end 12 of the stent graft 1 are both fixed, the stent graft 1 is relative to the outer tube during the delivery process.
  • the outer tube 52 introduces the stent graft 1 into the vicinity of the lesion of the blood vessel 7 to achieve initial positioning, as shown in Figure 5; then, the outer tube 52 is withdrawn and retained
  • the inner tube 51 stays in place to at least completely expose the entire area of the stent graft 1, that is, to expose the area from the proximal end (that is, the bare stent section) 10 to the distal end 12 of the stent graft 1, and also expose the stent graft 1
  • a part of the inner tube 51 outside the distal end 12 of the membrane stent 1 is shown in FIG. 6.
  • the stent graft 1 is continuously fixed on the inner tube 51 by the rear release device 4, the restraining device, and the control guide wire 22.
  • the position of the bracket 1 remains unchanged.
  • the stent graft 1 is accurately positioned to determine the exact release position of the stent graft 1; after that, the inner tube 51 is kept still, and the control guide wire 22 is retracted so as to move along The direction from the proximal end (i.e. bare stent section) 10 of the stent graft 1 to the distal end 12 gradually loosens the binding line 21 on the stent graft 1 to gradually release and pop off the middle section 11 and the distal end of the stent graft 1 12. Make it adapt to the size of the blood vessel and expand to a suitable size, that is, reach the expansion state that is compatible with the blood vessel 7.
  • the speed of the withdrawal control guide wire 22 determines the release speed of the stent graft 1, and the control guide wire is withdrawn When 22 is faster, the stent graft 1 can be released quickly; (3) The proximal end (ie, the bare stent section) 10 of the stent graft 1 is released later through the rear release device 4.
  • the rear release guide wire 46 on the rear release device 4 is pulled, so that the rear release rear end 44 moves in a direction away from the tapered head 41, so that the rear release screw 43 escapes from the fixing hole 410 of the tapered head 41 , Until the rear release screw 43 is retracted into the guide hole 421 of the rear release fixing member 42, at this time, the proximal end (ie bare stent section) 10 of the stent graft 1 is completely released by the rear release screw 43, that is, the rear The release device 4 completely releases the proximal end (that is, the bare stent section) 10 of the stent graft 1, and the proximal end (that is, the bare stent section) 10 of the stent graft 1 is released and will anchor to the lesion of the blood vessel 7 after deployment.
  • the binding wire 21 can be left in the body, and the positioning guide wire 6 also needs to be removed from the body to complete the implantation of the stent graft 1.
  • the stent delivery system of the present invention includes a handle, an outer tube, a restraint device, and a rear release device.
  • the structure is simple and easy to use.
  • the rear release device can be assembled with the proximal end of the stent (that is, the end close to the lesion). Together, the stent is bound to the restrained state by the restraint device, and then pressed into the outer tube, and then the stent can be transported to the diseased location through the outer tube for release.
  • the stent During the release of the middle section of the stent by the restraint device, the stent The proximal end of the stent is always fixed by the rear release device, thereby avoiding the problem of backward movement of the stent caused by blood impact, and improving the positioning accuracy of the stent release.
  • the restraint wire in the restraint device is controlled by the control guide wire to open and close. During the slow withdrawal of the control guide wire, the stent can be gradually released from near to far as the control guide wire is withdrawn. In the expanded state, the stable release of the stent can be realized, and the accuracy of the position of the stent can be ensured.
  • the distal end of the stent can be fixed on the inner tube by the fixing coil on the stent, and the proximal end of the stent is fixed by the rear release device, thereby avoiding the forward jumping and the stent during the middle release of the stent.
  • the shortening problem truly realizes the precise control and release of the stent.

Abstract

一种支架输送系统及装载支架（1）的方法，支架输送系统包括手柄、外管（52）、束缚装置和后释放装置（4），结构简单、使用方便，在支架（1）被束缚装置释放过程中，支架（1）的近端被后释放装置（4）一直固定住，由此避免了血液冲击导致的支架（1）后移问题，提高支架（1）释放定位精准性；此外，在支架（1）被束缚装置释放过程中，支架（1）的远端能够通过固定线圈（32）固定到内管（51）上，支架（1）的近端能够保持固定在后释放装置（4）上，由此能够在支架（1）的中段释放过程中避免支架（1）的前跳和短缩问题，真正实现了支架（1）的精准控位释放。

Description

支架输送系统及装载支架的方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种支架输送系统及装载支架的方法。
背景技术
胸主动脉瘤或夹层是一种致命性的血管外科疾病，其发病率并不低。上世纪90年代之前，医学上一直采用传统外科治疗法来治疗胸主动脉瘤或夹层疾病，但是该治疗方法存在手术难度大、创伤大、且并发症较多等缺点。直至1994年，Dake等首次将血管腔内覆膜支架植入术用于主动脉夹层，随之介入治疗手术得到了极大的发展。介入治疗手术一般是通过股动脉穿刺将覆膜支架经过外鞘送入体内，并随着大动脉通道达到主动脉病变位置，覆盖并修复病变血管。其中，覆膜支架是指支架本体内面或外面部分或完全覆盖膜性材料的人工体内移植物。
覆膜支架治疗夹层原理就是通过特制的输送系统将覆膜支架送入病变部位后释放而张开，覆膜支架上的膜性材料会隔绝主动脉夹层的破裂口，阻断血液继续流入夹层的假腔，避免夹层的进一步撕裂甚至破裂，而覆膜支架的支架本体则起到支撑血管壁的作用，避免血液流入假腔后，对真腔产生压迫，而影响血流的流动和组织器官的血液供应。封堵破裂口往往需要覆膜支架的近端有一段健康血管作为支架锚定区，可是破裂口往往很靠近重要的分支血管，所以支架锚定区往往很短、很有限且很珍贵，而覆膜支架在释放过程中，经常会因血流冲击出现后移或因系统设计问题出现前跳等支架释放定位不准确的问题，由此造成包括支架锚定区在内的分支血管被完全封堵或破裂口封堵不完全的不良现象，分支血管被完全封堵后会导致器官缺血或脑缺血等影响患者健康的不良后果，而破裂口封堵不完全会导致内漏等影响患者健康的不良后果。
发明内容
本发明的目的在于提供一种支架输送系统及装载支架的方法，能够避免 因血流冲击而出现的支架后移问题，提高支架释放定位精准性。
为了实现上述目的，本发明提供一种支架输送系统，包括：手柄、外管、束缚装置和后释放装置；
所述外管具有沿轴向延伸的内腔，用于容纳压缩后的支架，并在所述手柄的控制下向近端回撤，以暴露所述支架；
所述束缚装置包括至少一条束缚线和控制导丝，所述束缚线被配置为围绕所述支架的周向设置，所述控制导丝用于控制所述束缚线形成开环或闭环结构，以压缩或释放所述支架；
所述后释放装置设置在所述外管内，被配置为与所述支架的近端可拆卸连接，用于约束或释放所述支架的近端。
可选地，所述束缚装置包括至少两条所述束缚线，至少两条所述束缚线被配置为沿所述主体部的轴向间隔设置。
可选地，所述束缚线为两端闭合的双股束缚线，所述双股束缚线被配置为在围绕所述支架至少一周后所述双股束缚线的头端从尾端中穿过，所述控制导丝被配置为从所述双股束缚线的头端中穿过，以使所述双股束缚线形成闭环结构；或者，所述双股束缚线被配置为围绕所述支架至少一周，所述控制导丝被配置为从所述双股束缚线的头端和尾端中穿过，以使所述双股束缚线形成闭环结构。
可选地，所述支架上设有固定线圈，所述束缚线被配置为从所述固定线圈中穿过。
可选地，所述支架上设有多个固定线圈，至少两个所述固定线圈围绕所述支架的周向间隔设置，所述束缚线被配置为从所述至少两个所述固定线圈中穿过。
可选地，所述输送系统还包括内管，所述内管设置在所述外管内，所述外管与所述内管之间具有间隙，用于容纳所述支架，所述后释放装置中设有供所述内管穿过的通路。
可选地，所述后释放装置包括锥形头、后释放固定件、后释放后端、若干根后释放丝杆和后释放导丝，所述锥形头远端设有与所述后释放丝杆相匹配的若干固定孔，所述后释放固定件中设有与所述后释放丝杆相匹配的若干 导引孔，所述若干根后释放丝杆的远端均与所述后释放后端固定连接，所述若干根后释放丝杆的近端分别穿过所述后释放固定件中的对应的导引孔并插入所述锥形头上的对应的固定孔中，所述后释放导丝的近端与所述后释放后端固定连接，所述后释放丝杆的位于所述锥形头与所述后释放固定件之间的杆段用于穿过并束缚所述支架的近端。
可选地，所述锥形头、所述后释放固定件和所述后释放后端中均设有供所述内管穿过的通路，所述内管的一端与所述锥形头连接，并依次穿过这些通路。
可选地，所述内管的位于所述后释放后端的远端一侧的管段上设有限位块，所述限位块的外径大于所述后释放后端中通路的直径。
基于同一发明构思，本发明还提供一种装载支架的方法，包括：
将支架的近端安装到输送系统的后释放装置上固定；采用至少一条束缚线围绕所述支架的周向设置，并通过一控制导丝控制所述束缚线形成闭环结构，以将所述支架压缩；将压缩后的所述支架连同输送系统的内管和后释放装置压握到输送系统的外管的内腔中，所述外管的远端固定连接一手柄。
与现有技术相比，本发明的技术方案具有以下有益效果：
本发明的支架输送系统，包括手柄、外管、束缚装置和后释放装置，结构简单、使用方便，可以通过后释放装置与支架的近端(即靠近病变位置的一端)装配到一起，并通过束缚装置将支架束缚到束缚状态，进而压握到所述外管内，之后通过外管和手柄可以将所述支架输送至病变位置，进行释放，在支架被束缚装置释放过程中，其近端被后释放装置一直固定住，由此避免了血液冲击导致的支架后移问题，提高支架释放定位精准性。另外，所述束缚装置由控制导丝控制开合，在控制导丝缓慢撤出的过程中，所述支架能够随着控制导丝的撤出步伐由近及远的逐渐释放至膨胀状态，由此能够实现支架的稳定释放，保证支架位置的精准性。此外，在支架被束缚装置释放过程中，支架的远端能够通过固定线圈固定到内管上，支架的近端能够保持固定在后释放装置上，由此能够在支架的中段释放过程中避免支架的前跳和短缩问题，真正实现了支架的精准控位释放。
附图说明
图1是本发明具体实施例的束缚装置束缚支架的结构示意图；
图2是本发明具体实施例的束缚装置束缚支架的结构示意图；
图3是本发明具体实施例的后释放装置与支架的近端配合的结构示意图；
图4是本发明具体实施例的后释放后端的结构示意图；
图5至图8是通过本发明具体实施例的支架输送系统输送支架的方法中的结构示意图；
其中，附图标记如下：
1-支架、覆膜支架；10-裸支架段、支架的近端；11-支架的中段；12-支架的远端；21-束缚线；211-束缚线的头端；212-束缚线的尾端；22-控制导丝；31-支架上的固定件；32-固定线圈；4-后释放装置；41-锥形头；410-锥形头上的固定孔；42-后释放固定件；421-后释放固定件上的导引孔；43-后释放丝杆；44-后释放后端；441-后释放后端中的通路；442-第一小孔；443-第二小孔；45-限位块；46-后释放导丝；51-内管；52-外管；6-定位导丝；7-血管。
具体实施方式
为使本发明的目的、特征更明显易懂，下面结合附图对本发明的技术方案作详细的说明，然而，本发明可以用不同的形式实现，不应只是局限在所述的实施例。在本文中，术语“近端”是指医疗器械在正常操作过程中靠近安装位置(例如心脏、血管病变处等)的一端，也就是支架输送系统前进的前端，即远离操作人员的一端，而“远端”通常是指所述医疗器械远离所述安装位置的一端，即为靠近操作人员的一端，也就是靠近手柄所在的一端。
请参考图1至图8，本发明一实施例提供一种支架输送系统，包括：手柄、外管52、束缚装置和后释放装置4。
请参考图5～7，所述外管52具有沿轴向延伸的内腔，用于容纳压缩后的支架1，并在所述手柄的控制下向所述支架1的远端回撤，以暴露所述支架1。此外，本实施例的支架输送系统还包括内管51，所述内管51设置在所述外管52内，所述外管52与所述内管51套设在一起且两者之间具有间隙，用于容纳所述支架1，且后释放装置4中设有供所述内管51穿过的通路，内管51的 近端和后释放装置4的近端固定连接在一起。支架1可以套设在内管51上，且近端装配到后释放装置4上，其余部分被束缚装置压缩，装配在一起的支架1、束缚装置以及后释放装置4的远端和中段一并可移动地置入外管52和内管51的间隙中。
本实施例中，所述支架输送系统能够输送的支架1可以是覆膜支架，也可以是非覆膜支架或裸支架。其中，裸支架通常为不锈钢和/或记忆金属材料制成的管腔结构，可以套设在所述内管51上，其表面上无高分子覆膜材料，当将裸支架向血管内植入时，可以将裸支架压缩为伸直状态以方便植入，在植入到病变血管位置后，裸支架可恢复至与病变位置的血管相匹配的弯曲状态，由此可以避免因覆膜支架的回弹力作用在局部血管壁上而导致的并发症。一种裸支架的结构例如为由环状Z形支架圈和金属网格支架交替连接为一体的管腔结构，或者例如为金属网格形成的管腔结构。覆膜支架相对裸支架的区别在于在金属支架本体上覆盖有覆膜，该覆膜可以对金属支架本体的外表面或内表面进行全面覆盖，也可以仅仅覆盖在金属支架本体的中段上，还可以覆盖在金属支架本体的中段和远端上，甚至还可以不连续的覆盖在金属支架本体中段的多个位置上。覆膜整体上也呈管腔结构，可以套设在内管51上。覆膜支架也可以比较容易在弯曲状态和伸直状态之间转换，当将覆膜支架向血管内植入时，可以将覆膜支架压缩为伸直状态以方便植入；在植入到病变血管位置后，覆膜支架可恢复至与病变位置的血管相匹配的弯曲状态，由此可以避免因覆膜支架的回弹力作用在局部血管壁上而导致的并发症。覆膜支架通常包括金属支架本体以及覆盖在所述金属支架本体的内表面或外表面上的覆膜，所述金属支架本体可以是由不锈钢或记忆金属材料等金属材料制作而成的镂空弹性结构，能够被束缚压缩以及被释放膨胀，且可进行横向伸缩或纵向起伏，使得金属支架本体的直径和/或长度进行改变调整，从而使覆膜支架与血管更紧密地贴合，降低内漏风险，所述金属支架本体可以是金属丝编织的金属网格，可以是由若干环状Z形波支架圈和固定连接这些环状Z形波支架圈的多根支架脊骨组成的结构，还可以是多根支架脊骨及其固定连接的环状Z形波支架圈和金属网格组成的结构。
请参考图1至图8，本实施例中，支架1为覆膜支架，主要由金属支架本 体以及覆盖在金属支架本体表面上的覆膜组成，支架1具有靠近病变位置的近端10、远离病变位置的远端12以及连接在近端10和远端12之间的中段11，支架1的近端为无覆膜覆盖的裸支架段，支架1的中段11和远端12的金属支架本体的外表面均被覆膜覆盖。优选地，支架1的金属支架本体采用记忆金属材料制作，所述记忆金属材料具有记忆效果，例如为NiTi合金，可以解决采用其他材料制作而成存在变形不符合要求的问题。所述支架1的所述覆膜采用高分子材料制作，所述高分子材料例如为聚酯材料(PET)、聚四氟乙烯(PTFE)、尼龙、涤纶和聚丙烯等等，所述覆膜可以采用聚酯缝合线缝合在金属支架本体上，也可以通过压塑工艺成型在所述金属支架本体上，所述覆膜上优选地设置有用于显影的显影标志，所述显影标志例如为铂铱合金显影点，能够使得用户在支架1的导入和释放过程中能通过显影设备动态监测支架1的位置，进而调整支架1至最佳位置，达到精准定位释放的目的。
请参考图1至图8，本实施例中，裸支架段10即支架的近端，用于增加支架1与血管壁的锚定力，其可以包括至少一个未被覆膜包覆的波形环状物，该波形环状物可由金属丝编织或金属管切割成所需的波形，也可以包括多根分布呈爪状的金属丝，还可以是金属网格。优选的，在本发明中，裸支架段10上还形成有一层具有生物相容性的阻挡层，该阻挡层优选聚四氟乙烯层。聚四氟乙烯层可以通过以下方式形成：一种是采用长条形的聚四氟乙烯膜缠绕在用于形成裸支架段10的金属丝或金属管的表面。另一种是通过喷涂的方式将液态的聚四氟乙烯喷涂在裸支架段10的表面，该阻挡层可以达到防止裸支架段表面的血栓形成、抑制二价镍离子等的释放以及保护裸支架段10不受体液中氯化物等离子侵蚀的目的，具有良好的抗血栓、耐蚀、防止金属毒性离子溶出的性能。裸支架段10可以呈直筒形、由近及远逐渐变粗的喇叭形或由近及远渐粗的锥形。并且裸支架段10可以通过多个点相连接的方式固定到支架1的覆膜上，也可以通过一体成型或者焊接等方式与被覆膜覆盖金属支架本体区域相连接。
请参考图1至图8，所述束缚装置被装配到支架1的中段11和远端12上并能相对所述支架1的中段11和远端12进行开合，在闭合时将支架1的中段11和远端12束缚至束缚状态，在打开时将支架1的中段11和远端12释 放至膨胀状态。所述束缚装置包括至少一条束缚线21和控制导丝22，所述束缚线21被配置为围绕所述支架1的周向设置，所述控制导丝22用于控制所述束缚线21形成开环或闭环结构，以压缩或释放所述支架1。
请参考图1和图2，本实施例中，所述束缚装置包括至少两条束缚线21，且所有的束缚线21沿所述支架1的金属支架本体(即支架1的主体部)的轴向间隔设置，能够在控制导丝22的控制下将支架1的直径约束至目标直径。且相邻的束缚线21之间具有一段间隔(即一段无束缚线缠绕的支架1)，能够避免束缚线21和束缚线21之间以及控制导丝22和束缚线21之间互相缠绕打结的问题。优选地，束缚线21的材质是人体可吸收的材质，在后续被人体降解吸收。本实施例中，每条所述束缚线21为两端闭合的双股束缚线，所述双股束缚线被配置为在围绕所述支架1至少一周后，所述双股束缚线的头端211从尾端212中穿过，所述控制导丝22被配置为从所述双股束缚线的头端211中穿过，以使所述双股束缚线形成闭环结构；或者，所述双股束缚线被配置为围绕所述支架至少一周，所述控制导丝22被配置为从所述双股束缚线的头端211和尾端212中穿过，以使所述双股束缚线形成闭环结构。此外，各条束缚线21束缚支架1后的直径可以相同，也可以不同。本实施例中，可以通过向支架1的远端回撤控制导丝22，来使得各条束缚线21由近及远地逐渐变为开环结构，进而使得支架1膨胀撑开，以实现支架1的释放。
在本发明的其他实施例中，每条束缚线21可以是单股束缚线，其缠绕在所述支架1的相应位置上至少一周后，能将所述支架1束缚至束缚状态，且各条束缚线21的尾端和头端在所述控制导丝22上打结，以在控制导丝22的控制下形成开环或闭环结构，以压缩或释放所述支架1。
优选地，支架1上设有固定件31，固定件31例如是从支架1的金属支架本体上伸出的锚勾或固定环等结构，所述束缚线21的尾端能通过支架1上的固定件31固定，以防止束缚线21形成的开环或闭环结构游移，进而一方面能有利于控制导丝22对束缚线21的头端和尾端的控制，另一方面能进一步避免束缚线21和束缚线21之间以及控制导丝22和束缚线21之间互相缠绕打结的问题。
请参考图2，本实施例中，支架1的远端12上还设有至少一条固定线圈 32，各条所述束缚线21被配置为从相应的所述固定线圈32中穿过。每条固定线圈的远端可以固定在内管51的远端上。且当有多条固定线圈时，这些固定线圈32优选地均匀布设在支架1的远端12的周围上，以使得支架1的远端12均匀受力，防止受力不均而发生支架1转动等问题。此外，控制导丝22能穿过这些固定线圈32中的一部分固定线圈32的近端，另一部分固定线圈32的近端被相应的束缚线21穿过。当控制导丝22被撤走以后，控制导丝22能穿过的这些固定线圈32可以自由的撤离，而近端被相应的束缚线21穿过的这些固定线圈32也会被支架1的膨胀弹力撑开，和支架1的远端12上的束缚线21一起实现支架1的远端12的释放，且因为这些近端被束缚线21穿过的固定线圈32的远端仍旧固定在内管51上，因此在支架1的远端12被释放前后均能保证支架1的远端12的位置不变，解决了支架1在释放弹开的过程中出现短缩、移位等问题。
请参考图3和图4，本实施例的后释放装置4用于约束和释放支架1的近端(即裸支架段)，后释放装置4具有套设在所述内管51上移动的部件以及固定在所述内管51上的部件。具体地，所述后释放装置4包括锥形头41、后释放固定件42、后释放后端44、若干根后释放丝杆43和后释放导丝46。其中，所述锥形头41固定设置在所述内管51的近端上，所述锥形头41的近端，即其直径较小的一端为所述输送系统前进的前端作引导用，能在输送支架1时减少该装配有支架的输送系统在人体血管内的阻力，方便输送，所述锥形头41的远端，即其直径较大且更靠近操作人员操作的一端设有与所述后释放丝杆43相匹配的若干固定孔410，所述后释放固定件42中设有与所述后释放丝杆43相匹配的若干导引孔421，所述若干根后释放丝杆43的远端均与所述后释放后端44固定连接，所述若干根后释放丝杆43的近端分别穿过所述后释放固定件42中的对应的导引孔421并插入所述锥形头41上的对应的固定孔410中，所述后释放导丝46的近端与所述后释放后端44固定连接，所述后释放丝杆43的位于所述锥形头41与所述后释放固定件42之间的杆段，用于穿过并束缚覆膜支架1的近端的裸支架段10。在本发明的其他实施例中，所述后释放固定件42上设置的导引孔421还可替换为脊、滑槽等结构。
安装覆膜支架1时，将其近端的裸支架段10分别套挂于各根后释放杆43 上，随后将后释放后端44往锥形头41方向推至极限位置，将后释放丝杆43沿后释放固定件42中的导引孔421插入锥形头41对应端的固定孔410中，从而实现了利用锥形头41和后释放固定件42夹持住后释放丝杆43而提供给裸支架段10的固定；释放覆膜支架1时，通过手柄拉动后释放导丝46，从而使后释放丝杆43脱离锥形头41中的固定孔410，实现覆膜支架1近端的裸支架段10的释放，裸支架段10由于自身的弹性张开，从而紧贴血管固定住覆膜支架1。所述后释放导丝46固定设置在所述后释放后端44的远端上。
由此可见，本实施例的后释放装置4能通过若干根后释放丝杆43实现支架1的近端的约束和释放，并通过其后释放固定件42有效地约束了支架1的近端，并增加了后释放丝杆43轴向移动的可靠性，且由于后释放丝杆43与固定孔410之间的接触面积小，因此在释放支架1时所受阻力较小，能提高整个释放过程的精度。
本实施例中，所述锥形头41、后释放固定件42和后释放后端44中均设有供所述内管51穿过的通路，所述内管51的近端与所述锥形头41的远端连接，并依次穿过这些通路。所述内管51的位于所述后释放后端44的远端一侧的管段上设有限位块45，所述限位块45的外径大于所述后释放后端44中通路441的直径，从而限制后释放后端44在释放裸支架段10时的位移(即限定所述后释放后端44的远端移动的极限位置)，不会使其过分移动而碰触损伤附近的血管，且在所述后释放后端44向着支架1的近端(即向着远离所述锥形头41)的方向移动时，限位块45能使得后释放后端44移动至极限位置停止，以避免后释放丝杆43完全从后释放固定件42中脱出。此外，在本实施例中，后释放丝杆43可以由不锈钢或镍钛合金等金属材质制成，后释放固定件42和锥形头41之间的区域的轴向长度在满足安装及释放要求的情况下需要足够短，以增大该区域中后释放丝杆43的刚性，减小后释放丝杆43受覆膜支架1膨胀力而产生的形变量。
进一步的，如图4所示，所述后释放后端44中的通路441设置于其中心，以所述通路441为中心围绕所述通路441均匀分布有用于固定所述若干根后释放杆43的若干第一小孔442，所述第一小孔442的数量例如为六个，所有的第一小孔442沿圆周方向等角度间隔设置于所述通路441周围，后释放丝 杆43的数量与第一小孔442的数量相同，且后释放丝杆43一一对应地固定于各个所述第一小孔442中。所述后释放后端44中的通路441周围还设有用于固定所述后释放导丝46的至少一个第二小孔443，所述第二小孔443的数量和后释放导丝46数量相同，各根所述后释放导丝46的一端从所述后释放后端44的远端穿入且一一对应地穿过所述第二小孔443至所述后释放后端44的近端，并从另一所述第二小孔443中穿回，所述后释放导丝46固定于所述第二小孔443中，其固定方式不限于焊接、胶水粘结、机械锁死等方式。
请参考图1至图8，本发明一实施例还提供一种装载、输送和释放支架的方法，以支架1为覆膜支架(以下均记作覆膜支架1)为例，包括以下过程：
装配覆膜支架1的步骤，分三步：(1)、覆膜支架1的近端被后释放装置固定住。具体地，后释放装置4和内管51事先装配在一起，此时各根后释放丝杆43一一对应地插入到后释放固定件42的导引孔421中，将覆膜支架1套在内管51上，并将覆膜支架1沿内管51移动，直至覆膜支架1的近端移动到后释放装置4的近端处，覆膜支架1的近端(即裸支架段)10穿插到后释放丝杆43上，然后推动后释放装置4的后释放导丝46，使得后释放装置4的后释放后端44沿内管51向锥形头41移动，后释放丝杆43在后释放后端44的带动下以及后释放固定件42的导引孔421的导向作用下，插入到锥形头41的固定孔410中，从而将覆膜支架1的裸支架段10固定住。(2)覆膜支架1被束缚线21捆住，具体地，利用束缚线21在覆膜支架1上进行缝合、缠绕，以围绕所述支架的周向设置，并在控制导丝22的控制下形成多个闭环结构(即束缚线圈)，这些闭环结构可以将支架1的中段11和远端12束缚到内管51上而呈束缚状态，例如，所述束缚线21为两端闭合的双股束缚线，所述双股束缚线21在围绕所述支架至少一周后，其头端211从尾端212中穿过，控制导丝22从所述双股束缚线的头端211中穿过，以使所述双股束缚线形成闭环结构，此时，后释放装置4固定了覆膜支架1的近端，束缚线和控制导丝22固定了覆膜支架1的中段11和远端12；(3)、覆膜支架1被压握在外管52内。具体地，将装配在一起的后释放装置4、束缚装置、覆膜支架1、内管51一起再压缩至最小直径，以装载到外管52的内腔中，外管52会沿着内管51移动，直至外管52的近端移动至锥形头41的近端，从而使得外管52将覆膜支 架1全部包围在内，并进一步将所述外管52的远端固定连接到一手柄上。
输送和释放覆膜支架1的步骤，与上述安装覆膜支架1的三步正好对应，也分为三步：(1)外管52将覆膜支架1导入至血管7的病变位置(或称为指定位置)附近初定位，回撤外管52。具体地，在正式输送覆膜支架1前，先通过穿刺技术将一定位导丝6的头端相应的血管7穿入到血管病变位置(或称指定位置，例如主动脉夹层)附近；在正式输送覆膜支架1时，沿定位导丝6将套设在一起并在两者的间隙中装载有支架1的内管51和外管52送入血管7内，直至外管52的近端到达血管7的病变位置附近，由于所述覆膜支架1的近端(即裸支架段)10和远端12均被固定，因此在输送过程中，所述覆膜支架1相对于所述外管52和内管51不会发生前后移动，此时外管52将覆膜支架1导入至血管7的病变位置附近，实现初定位，如图5所示；然后，回撤外管52，并保留内管51停留在原位，以至少完全暴露出覆膜支架1的全部区域，即暴露出覆膜支架1从近端(即裸支架段)10至远端12的区域，还可以暴露出覆膜支架1的远端12外侧的一部分内管51，如图6所示，此时，覆膜支架1被后释放装置4和束缚装置以及控制导丝22继续固定在内管51上，覆膜支架1的位置不变。(2)覆膜支架1精确定位后，由支架1的近端至支架1的远端的方向，依次快速松开各条束缚线21，以使得覆膜支架1由近及远地逐渐弹开至膨胀状态。具体地，通过调整内管51的位置，来对覆膜支架1进行精确定位，以确定覆膜支架1的准确释放位置；之后，保持内管51不动，回撤控制导丝22，从而沿覆膜支架1的近端(即裸支架段)10至其远端12的方向逐渐松开覆膜支架1上的束缚线21，以逐渐释放和弹开覆膜支架1的中段11和远端12，使其自适应血管大小而膨胀至合适大小，即达到与血管7相适配的膨胀状态，回撤控制导丝22的速度决定了覆膜支架1的释放速度，在回撤控制导丝22较快时，可以实现覆膜支架1的快速释放；(3)通过后释放装置4来将覆膜支架1的近端(即裸支架段)10后释放。具体地，拉动后释放装置4上的后释放导丝46，使得后释放后端44向着远离锥形头41的方向移动，从而使得后释放丝杆43从锥形头41的固定孔410中脱出，直至后释放丝杆43回撤至后释放固定件42的导向孔421中，此时覆膜支架1的近端(即裸支架段)10完全被后释放丝杆43释放，即实现了后释放装置4 对所述覆膜支架1的近端(即裸支架段)10的完全释放，覆膜支架1的近端(即裸支架段)10被释放展开后会锚定在血管7的病变位置的组织上，以实现覆膜支架1在血管7中的固定；之后，向后移动内管51以从体内撤走内管51，使得内管51和后释放装置4完全从人体内撤出，而束缚线21可以留在体内，定位导丝6也需要从体内撤走内，进而完成覆膜支架1的植入。
综上所述，本发明的支架输送系统，包括手柄、外管、束缚装置和后释放装置，结构简单、使用方便，可以通过后释放装置与支架的近端(即靠近病变位置的一端)装配到一起，并通过束缚装置将支架束缚到束缚状态，进而压握到外管内，之后通过外管可以将所述支架输送至病变位置，进行释放，在支架中段被束缚装置释放过程中，由于支架的近端被后释放装置一直固定住，由此避免了血液冲击导致的支架后移问题，提高支架释放定位精准性。另外，所述束缚装置中的束缚线由控制导丝控制开合，在控制导丝缓慢撤出的过程中，所述支架能够随着控制导丝的撤出步伐由近及远的逐渐释放至膨胀状态，由此能够实现支架的稳定释放，保证支架位置的精准性。此外，所述支架的远端能够通过支架上的固定线圈能够固定在内管上，同时支架的近端又被后释放装置固定，由此能够在支架的中段释放过程中避免支架的前跳和短缩问题，真正实现了支架的精准控位释放。
显然，本领域的技术人员可以对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 (10)

  1. 一种支架输送系统，其特征在于，所述支架输送系统包括：手柄、外管、束缚装置和后释放装置；
    所述外管具有沿轴向延伸的内腔，用于容纳压缩后的支架，并在所述手柄的控制下向所述支架的远端回撤，以暴露所述支架；
    所述束缚装置包括至少一条束缚线和控制导丝，所述束缚线被配置为围绕所述支架的周向设置，所述控制导丝用于控制所述束缚线形成开环或闭环结构，以压缩或释放所述支架；
    所述后释放装置设置在所述外管内，被配置为与所述支架的近端可拆卸连接，用于约束或释放所述支架的近端。
  2. 如权利要求1所述的支架输送系统，其特征在于，所述束缚装置包括至少两条所述束缚线，至少两条所述束缚线被配置为沿所述支架的主体部的轴向间隔设置。
  3. 如权利要求1所述的支架输送系统，其特征在于，所述束缚线为两端闭合的双股束缚线，所述双股束缚线被配置为在围绕所述支架至少一周后所述双股束缚线的头端从尾端中穿过，所述控制导丝被配置为从所述双股束缚线的头端中穿过，以使所述双股束缚线形成闭环结构；或者，所述双股束缚线被配置为围绕所述支架至少一周，所述控制导丝被配置为从所述双股束缚线的头端和尾端中穿过，以使所述双股束缚线形成闭环结构。
  4. 如权利要求1所述的支架输送系统，其特征在于，所述支架上设有固定线圈，所述束缚线被配置为从所述固定线圈中穿过。
  5. 如权利要求4所述的支架输送系统，其特征在于，所述支架上设有多个固定线圈，至少两个所述固定线圈围绕所述支架的周向间隔设置，所述束缚线被配置为从所述至少两个所述固定线圈中穿过。
  6. 如权利要求1所述的支架输送系统，其特征在于，所述支架输送系统还包括内管，所述内管设置在所述外管内，所述外管与所述内管之间具有间隙，用于容纳所述支架，所述后释放装置中设有供所述内管穿过的通路。
  7. 如权利要求6所述的支架输送系统，其特征在于，所述后释放装置包 括锥形头、后释放固定件、后释放后端、若干根后释放丝杆和后释放导丝，所述锥形头远端设有与所述后释放丝杆相匹配的若干固定孔，所述后释放固定件中设有与所述后释放丝杆相匹配的若干导引孔，所述若干根后释放丝杆的远端均与所述后释放后端固定连接，所述若干根后释放丝杆的近端分别穿过所述后释放固定件中的对应的导引孔并插入所述锥形头上的对应的固定孔中，所述后释放导丝的近端与所述后释放后端固定连接，所述后释放丝杆的位于所述锥形头与所述后释放固定件之间的杆段用于穿过并束缚所述支架的近端。
  8. 如权利要求7所述的支架输送系统，其特征在于，所述锥形头、所述后释放固定件和所述后释放后端中均设有供所述内管穿过的通路，所述内管的一端与所述锥形头连接，并依次穿过所述通路。
  9. 如权利要求8所述的支架输送系统，其特征在于，所述内管的位于所述后释放后端的远端一侧的管段上设有限位块，所述限位块的外径大于所述后释放后端中的通路的直径。
  10. 一种装载支架的方法，其特征在于，包括：
    将支架的近端安装到输送系统的后释放装置上固定；
    采用至少一条束缚线围绕所述支架的周向设置，并通过一控制导丝控制所述至少一条束缚线形成闭环结构，以将所述支架压缩；
    将压缩后的所述支架连同所述输送系统的内管和所述后释放装置压握到所述输送系统的外管的内腔中，所述外管的远端固定连接一手柄。
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