WO2020135229A1 - 支架输送装置和支架装载方法 - Google Patents

支架输送装置和支架装载方法 Download PDF

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Publication number
WO2020135229A1
WO2020135229A1 PCT/CN2019/126696 CN2019126696W WO2020135229A1 WO 2020135229 A1 WO2020135229 A1 WO 2020135229A1 CN 2019126696 W CN2019126696 W CN 2019126696W WO 2020135229 A1 WO2020135229 A1 WO 2020135229A1
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WO
WIPO (PCT)
Prior art keywords
layer
stent
catheter
expansion tube
tube
Prior art date
Application number
PCT/CN2019/126696
Other languages
English (en)
French (fr)
Inventor
吴旭闻
桂宝珠
梅杰
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
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Filing date
Publication date
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2020135229A1 publication Critical patent/WO2020135229A1/zh

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Classifications

    • 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
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • 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
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Definitions

  • the present invention relates to the technical field of medical devices, and particularly to a stent delivery device and a stent loading method.
  • the stress unevenness occurs when the stent is loaded into a sheath with a smaller inner diameter, especially for a self-expanding stent with a strong radial support force.
  • the inner diameter of the sheath is smaller, the phenomenon of uneven stress will be more serious, resulting in the worsening of the uniformity of the stent in the lumen of the sheath, and even the phenomenon of the indentation of the stent, which will reduce the uniformity of the stent loading. .
  • This problem is difficult to avoid, and it is more difficult to be found in the opaque sheath.
  • the stent will be twisted and invaded during the actual release process, seriously affecting the quality of the release, damaging the surrounding tissues, easily fatigue the valve, or even damage the delivery device. Affect the withdrawal of the conveyor system.
  • the object of the present invention is to provide a stent delivery device and a stent loading method to solve the problem of low loading uniformity after loading the stent into the conventional stent delivery device, and use the existing stent loading method to load
  • the bracket is easy to cause the problem that the loading uniformity of the bracket is not high.
  • the present invention provides a stent delivery device, which is used to deliver a stent, including a sheath tube and an inner catheter, the sheath tube is sleeved outside the inner catheter, the inner catheter has a An expanded state In the first expanded state, the stent can be compressed and held in the sheath, the inner catheter is in the shape of a balloon, and the outer surface of the inner catheter conforms to the inner wall of the stent in the compressed state , And the outer diameter of the inner catheter is smaller than the inner diameter of the sheath tube.
  • the inner catheter includes an outer layer expansion tube and an outer layer connection catheter, a distal end of the outer layer connection catheter is connected to the outer layer expansion tube, and the stent is sleeved on the outer layer On the outer surface of the expansion tube, in the first expanded state, the outer layer of expansion tube has a balloon shape.
  • the inner catheter further has a second expanded state; in the second expanded state, the outer expansion tube has a balloon shape, and the stent is located outside the sheath tube and is in expansion In this state, the outer surface of the outer layer expansion tube conforms to the inner wall of the stent, and the outer diameter of the outer layer expansion tube is greater than the outer diameter of the sheath tube.
  • the inner catheter further has an initial state, and the outer diameter of the inner catheter in the initial state is smaller than the outer diameter in the first expanded state.
  • the inner catheter further includes an inner layer expansion tube, an inner layer connection catheter, a connector, and a fixing member
  • the stent delivery device further includes a handle
  • the outer layer expansion tube is sleeved in the inner
  • the outer layer connection tube is sleeved on the outer surface of the inner layer connection tube
  • the distal end of the inner layer connection tube is connected to the inner layer expansion tube
  • the outer layer The distal end of the expansion tube and the distal end of the inner expansion tube are fixedly connected to the connector
  • the proximal end of the outer layer connection catheter and the proximal end of the inner layer connection catheter are fixedly connected to the handle.
  • the fixing member is fixedly arranged on the outer surface of the outer layer expansion tube and/or the outer layer connecting catheter, the fixing member is used to fix the stent, and the handle is used to drive the sheath tube to the inner catheter Along the axial direction of the inner catheter.
  • the outer layer expansion tube and the outer layer connection catheter and the inner layer expansion tube and the inner layer connection catheter surround a first outer layer lumen
  • the inner catheter further includes a An outer layer valve and a medium conveying device
  • the first outer layer valve is disposed between the first outer layer lumen and the medium conveying device
  • the medium conveying device is used to pass through the first outer layer valve Inject the medium into the first outer layer lumen.
  • the inner catheter includes an outer layer expansion tube, an outer layer connection catheter, a middle layer expansion tube, and a middle layer connection catheter, and a distal end of the outer layer connection catheter is connected to the outer layer expansion tube, the The distal end of the middle-layer connection catheter is connected to the middle-layer expansion tube, the outer-layer expansion tube and the outer-layer connection catheter are sleeved on outer surfaces of the middle-layer expansion tube and the middle-layer connection catheter, and the stent is sleeved On the outer surface of the outer expansion tube, in the first expanded state, the intermediate expansion tube has a balloon shape, and the outer layer expands The tube is folded.
  • the inner catheter further has a second expanded state, in the second expanded state, the outer expansion tube is balloon-shaped, the stent is located outside the sheath tube and is in expansion In this state, the outer surface of the outer-layer expansion tube conforms to the inner wall of the stent, and the outer diameter of the outer-layer expansion tube in the second expanded state is greater than the outer diameter of the sheath tube.
  • the inner catheter further has an initial state, in the initial state, the outer expansion tube and the intermediate expansion tube are folded, the intermediate expansion tube is in the first
  • the outer diameter in the expanded state is greater than the outer diameter of the outer expansion tube in the initial state.
  • the inner catheter further includes an inner layer expansion tube, an inner layer connection catheter, a connector, and a fixing member
  • the stent delivery device further includes a handle
  • the middle layer expansion tube is sleeved on the inner layer
  • the middle-layer connection catheter is sleeved on the outer surface of the inner-layer connection catheter
  • the distal end of the inner-layer connection catheter is connected to the inner-layer expansion tube
  • the outer-layer expansion tube The distal ends of the middle layer expansion tube and the inner layer expansion tube are fixedly connected to the connector, the proximal ends of the outer layer connection catheter, the middle layer connection catheter, and the inner layer connection catheter and the handle
  • the fixing member is fixedly arranged on the outer surface of the outer layer expansion tube and/or the outer layer connection catheter
  • the fixing member is used to fix the stent
  • the handle is used to drive the sheath
  • the tube moves along the axial direction of the inner catheter on the outer surface of the inner catheter.
  • the outer layer expansion tube and the outer layer connection catheter and the middle layer expansion tube and the middle layer connection catheter surround a second outer layer lumen, the middle layer expansion tube and the middle layer
  • the connecting catheter and the inner-layer expansion tube and the inner-layer connecting catheter enclose a middle-layer lumen.
  • the inner catheter further includes a second outer-layer valve, a middle-layer valve, and a medium delivery device.
  • the second outer-layer valve is provided at Between the second outer layer lumen and the medium conveying device, the middle layer valve is disposed between the middle layer lumen and the medium conveying device, and the medium conveying device is used to pass the middle layer valve toward A medium is injected into the middle layer lumen, and a medium is injected into the second outer layer lumen through the second outer layer valve.
  • the present invention also provides a stent loading method of the above stent delivery device, comprising: pressing the stent sleeved on the outer surface of the inner catheter into the lumen of the sheath tube; Inject a medium into the lumen of the inner catheter, and expand the inner catheter to the first expanded state, so that the inner catheter is in a balloon shape, and fit the outer surface of the inner catheter to the pressure grip The inner wall of the bracket in the state.
  • the method further includes releasing the medium in the lumen of the inner catheter, so that the inner catheter is in an initial state.
  • a stent delivery device and a stent loading method provided by the present invention have the following beneficial effects:
  • the inner catheter Since the stent sleeved on the outer surface of the inner catheter is pressed and held in the lumen of the sheath tube, and in the first expanded state, the inner catheter has a balloon shape, and the outer surface of the inner catheter The inner wall of the stent in a crimped state is fit, and the outer diameter of the inner catheter is smaller than the inner diameter of the sheath tube. Therefore, the stent can be expanded by the inner catheter, and the shape of the stent crimped in the sheath tube can be adjusted.
  • the uneven stress of the stent held in the sheath can be reduced, the circumferential uniformity of the stent can be improved, and the phenomenon of the inward depression of the stent can be reduced, which can improve the loading uniformity of the stent, thereby reducing the stent due to the above Phenomenon leads to distortion and indentation during the release process, which affects the release quality, damages the surrounding tissue, affects valve fatigue, even damages the delivery system, and affects the risk of withdrawal function, which can improve the success rate of stent release.
  • FIG. 1 is a schematic structural view of a stent
  • FIG. 2 is a schematic structural diagram of a stent delivery device in Embodiment 1 of the present invention.
  • FIG. 3 is a schematic structural view of the stent in the stent delivery device in Embodiment 1 of the present invention after expansion;
  • FIG. 4 is a stent delivery device in Embodiment 1 of the present invention in the folded state of the inner catheter Sectional schematic
  • FIG. 5 is a schematic cross-sectional view of the stent delivery device in FIG. 4 taken along line A-A;
  • FIG. 6 is a schematic cross-sectional view of a first intermediate expansion tube in an inner catheter in an expanded state in a stent delivery device according to Embodiment 1 of the present invention
  • FIG. 7 is a schematic structural view of a stent delivery device loaded with a stent in Embodiment 1 of the present invention
  • FIG. 8 is a partially enlarged schematic view of the stent delivery device and the stent in FIG. 7;
  • FIG. 9 is another schematic structural view of the stent delivery device loaded with the stent in Embodiment 1 of the present invention.
  • FIG. 10 is a partially enlarged schematic view of the stent delivery device and the stent in FIG. 9;
  • FIG. 11 is a schematic structural view of the stent after being released from the sheath in the first embodiment of the present invention.
  • FIG. 12 is a schematic structural view of the stent in the first embodiment of the present invention after it is released from the sheath in the heart;
  • FIG. 13 is another schematic view of the structure of the stent after being released from the sheath in the first embodiment of the present invention;
  • FIG. 14 is another schematic structural view of the stent after being released from the sheath in the heart in the first embodiment of the present invention.
  • FIG. 15 is a schematic cross-sectional view of a stent delivery device in a contracted state in Embodiment 2 of the present invention.
  • FIG. 16 is a schematic cross-sectional view of the stent delivery device in FIG. 15 along line B-B;
  • FIG. 17 is a schematic cross-sectional view of the stent delivery device in Embodiment 2 of the present invention in the first expanded state.
  • 600-outer tube assembly 610-sheath tube; 620-outer tube;
  • FIG. 1 is a schematic structural diagram of a stent 100.
  • the stent 100 includes two fixing ears 110 and a net-shaped inflow channel structure 120 and an outflow channel structure 130.
  • the inflow channel structure 120 and The outflow channel structure 130 is connected, and the two fixing ears 110 are connected to the outflow channel structure 130.
  • the stent 100 generally needs to be loaded into the stent delivery device first, and then delivered to the lesion via the stent delivery device, and then the stent delivery device releases the stent 100 to the corresponding position, thereby implanting the stent 100 into the corresponding position, Treat the lesion. After the stent 100 is released to the corresponding position, it may be necessary to adjust the position and shape of the stent 100 using a stent delivery device or other medical instruments, so as to fully exert the therapeutic effect of the stent 100.
  • the stent 100 is loaded into the stent delivery device, it is usually pressed onto the inner catheter by the sheath in the stent delivery device.
  • the sheath tube is sleeved on the outer surface of the stent 100, and the inflow channel structure 120 and the outflow channel structure 130 in the stent 100 are sleeved on the outer surface of the inner catheter.
  • the fixing ear 110 is fixed in the sheath tube. In this state, the stent 100 is in a compressed state. Due to the small inner diameter of the sheath, the stent 100 is prone to uneven stress, especially for the self-expanding stent 100 with strong radial support force.
  • the phenomenon of uneven stress in the stent 100 is more common, and it is easy to deteriorate the circumferential uniformity of the stent 100 in the lumen of the sheath, and even the phenomenon that the stent 100 is recessed inwardly may reduce the loading uniformity of the stent 100.
  • the present invention provides a stent delivery device for delivering stents.
  • the stent delivery device includes an inner catheter and a sheath tube.
  • the sheath tube is sleeved on the outer surface of the inner catheter, and the inner catheter is used to expand and hold the stent held in the lumen of the sheath tube.
  • the sheath tube is sleeved on the outer surface of the inner catheter, and the inner catheter is used to expand and hold the stent held in the lumen of the sheath tube, when the sheath tube presses the stent on the inner catheter, it can pass
  • the inner catheter expands the stent, thereby reducing the phenomenon of uneven stress of the stent held in the lumen of the sheath, improving the circumferential uniformity of the stent, and reducing the phenomenon of inward depression of the stent, which can improve stent loading Uniformity, thereby reducing the risk of stent distortion or indentation during the release process due to the above phenomenon, which affects the quality of release, damages surrounding tissues, affects valve fatigue, even damages the delivery system, and affects the risk of withdrawal function. Improve the success rate of stent release.
  • the present invention also provides a stent loading method, when the sheath tube presses the stent on the inner catheter, the stent loading method expands and presses the stent in the lumen of the sheath tube through the inner catheter, Thereby improving the support Loading uniformity, which in turn improves the success rate of stent release.
  • FIG. 2 is a schematic structural diagram of a stent delivery device in Embodiment 1 of the present invention
  • FIG. 3 is a schematic structural diagram of an inner catheter 300 in the stent delivery device in Embodiment 1 of the present invention after expansion
  • FIG. 4 is a first embodiment of the present invention 5 is a schematic cross-sectional view of the stent delivery device in FIG. 4 along the line AA
  • FIG. 6 is a schematic view of the internal catheter in the stent delivery device in Embodiment 1 of the present invention.
  • a schematic cross-sectional view of the first intermediate expansion tube in an expanded state referring to FIGS.
  • the stent delivery device includes an outer tube assembly 200, an inner catheter 300, a handle 400, a media delivery device, a first outer layer valve 510, and an intermediate layer Valve 520 and the first inner valve.
  • the inner catheter 300 includes a connection head 310, a support catheter 320, a connection catheter 330, and a fixing member 370 which are sequentially connected from the distal end to the proximal end.
  • the outer tube assembly 200 is sleeved on the outer surface of the inner tube 300. Specifically, the outer tube assembly 200 is sleeved on the outer surface of the support conduit 320 and/or the connection conduit 330, and the handle 400 is used to drive the outer tube assembly 200 on the support conduit 320 And the outer surface of the connecting pipe 330 moves along the axial direction of the supporting pipe 320 and the connecting pipe 330.
  • the outer tube assembly 200 includes a sheath tube 210 and an outer tube 220, the sheath tube 210 is fixedly connected to the outer tube 220, and the outer tube 220 is connected to the handle 400.
  • the sheath tube 210 is used to hold and hold the stent 100.
  • the outer tube 220 can be specifically connected to the movable part in the handle 400, so that the movable part in the handle 400 can be driven to move, and then the outer tube 220 and the sheath tube 210 can be driven by the movable part in the handle 400 in the
  • the outer surfaces of the support duct 320 and the connection duct 330 move along the axial direction of the support duct 320 and the connection duct 330.
  • the outer tube assembly 200 can be driven by the handle 400 to move along the axial direction of the support tube 320 and the connection tube 330, but cannot rotate around the axial direction of the support tube 320 and the connection tube 330 In order to reduce the deformation of the bracket 100 held in the outer tube assembly 200 due to the rotation of the outer tube assembly 200, the release of the bracket 100 The risk of lowering the success rate.
  • the inner diameter and outer diameter of the sheath tube 210 are greater than the inner diameter and outer diameter of the outer tube 220, so as to reduce the impact of the stent delivery device on the human body during the delivery of the stent 100 to the lesion.
  • the outer tube assembly 200 may be made of one or more of metal materials and polymer/metal composite materials.
  • the support catheter 320 and the connection catheter 330 may be accommodated in the lumen of the outer tube assembly 200.
  • the distal end of the support catheter 320 is connected to the connection head 310
  • the proximal end of the support catheter 320 is connected to the distal end of the connection catheter 330
  • the support catheter 320 is used to expand and hold the sheath 210 In the stent 100 in the lumen
  • the proximal end of the connecting catheter 330 is fixedly connected to the handle 400.
  • the support catheter 320 includes a first outer layer expansion tube 321, a first middle layer expansion tube 322, and a first inner layer expansion tube 323.
  • the first outer layer expansion tube 321 is sleeved on the outer surface of the first middle layer expansion tube 322, and the first middle layer expansion tube 322 is sleeved on the outer surface of the first inner layer expansion tube 323 .
  • the distal ends of the first outer layer expansion tube 321, the first middle layer expansion tube 322, and the first inner layer expansion tube 323 are fixedly connected to the connector 310, and the first outer layer expansion tube 321, the first middle layer expansion
  • the proximal ends of the tube 322 and the first inner layer expansion tube 323 are fixedly connected to the distal end of the connecting catheter 330.
  • the first outer layer expansion tube 321 and the first middle layer expansion tube 322 have a folded state and an expanded state, respectively.
  • the outer surface of the first outer layer expansion tube 321 is folded in a folded state, and expanded in a balloon shape in the expanded state.
  • the outer surface of the first intermediate expansion tube 322 is folded in the folded state, and expanded in a balloon shape in the expanded state.
  • the outer diameter and structure of the first inner layer expansion tube 323 will not change with different working conditions.
  • the outer diameter of the outer surface of the first outer layer expansion tube 321 in the expanded state is greater than the outer diameter of the sheath tube 210, and the outer surface of the first intermediate layer expansion tube 322 in the expanded state The outer diameter of is smaller than the inner diameter of the sheath tube 210.
  • the outer diameter of the outer surface of the first outer layer expansion tube 321 in the expanded state ranges from 16 mm to 40 mm, and the outer surface of the first middle layer expansion tube 322 in the expanded state The outer diameter ranges from 4 mm to 13 mm.
  • the material of the first inner layer expansion tube 323 may be one of a polymer material and a polymer/metal composite material.
  • the materials of the first middle expansion tube 322 and the first outer expansion tube 321 may be polymer materials.
  • the connection head 310 and the support catheter 320 are sequentially connected from the distal end to the proximal end.
  • the connecting head 310 is a tapered head, the large end of the tapered head is connected to the support tube 320, and the small end of the tapered head is a free end.
  • the connector 310 may have other shapes, such as a gradual columnar structure whose outer diameter gradually increases from the distal end to the proximal end of the connector 310.
  • the connector 310 preferably adopts a streamlined design to reduce the resistance to movement of the connector 310.
  • the connector 310 is preferably made of polymer material.
  • connection duct 330 includes a first outer layer connection duct 331, a first middle layer connection duct 332, and a first inner layer connection duct 333.
  • the first outer layer connecting pipe 331 is sleeved on the outer surface of the first middle layer connecting pipe 332, and the first middle layer connecting pipe 332 is sleeved outside the first inner layer connecting pipe 333 On the surface.
  • the distal end of the first outer layer connection catheter 331 is connected to the first outer layer expansion tube 321, the distal end of the first intermediate layer connection catheter 332 is connected to the first intermediate layer expansion tube 322, and the first inner layer connection catheter
  • the distal end of 333 is connected to the first inner layer expansion tube 323.
  • the proximal ends of the first outer-layer connection catheter 331, the first middle-layer connection catheter 332, and the first inner-layer connection catheter 333 are fixedly connected to the handle 400.
  • first outer layer connecting tube 331 and the first outer layer expansion tube 321 and the first middle layer connecting tube 332 and the first middle layer expansion tube 322 enclose a first outer layer lumen 340;
  • the first middle layer connecting tube 332 and the first middle layer expanding tube 322 and the first inner layer connecting tube 333 and the first inner layer expanding tube 323 enclose a middle layer lumen 350;
  • the first inner layer The lumen connecting the catheter 333 and the first inner layer expansion tube 323 is the inner layer lumen 360
  • the outer diameters and structures of the first outer layer connecting duct 331, the first middle layer connecting duct 332, and the first inner layer connecting duct 333 will not change with different working states.
  • the materials of the first outer layer connecting pipe 331, the first middle layer connecting pipe 332, and the first inner layer connecting pipe 333 may be one of a polymer material and a polymer/metal composite material.
  • the first outer layer connecting duct 331, the first middle layer connecting duct 332, and the first inner layer connecting duct 333 are connected to the fixing member in the handle 400 to restrict the support duct 320 and the connecting duct 330
  • the six degrees of freedom allow the support tube 320 and the connection tube 330 to be fixed relative to the handle 400, thereby reducing the risk of displacement of the stent 100 loaded on the delivery device.
  • the first inner-layer expansion tube 323 and the first inner-layer connecting catheter 333 may use a tube with a uniform material distribution It can be woven, or two pipes can be separately manufactured and fixedly connected. The diameter of the two pipes can be the same.
  • the first intermediate expansion tube 322 and the first intermediate connection tube 332 are made of different materials, and then fixedly connected.
  • the first outer layer expansion tube 321 and the first outer layer connection pipe 331 are made of different materials, and then fixedly connected.
  • the purpose of using different materials is to make the first outer layer expansion tube 321 and the first middle layer expansion tube 322 foldable in the folded state, and expandable into a balloon shape in the expanded state; the first outer layer connecting catheter 331
  • the outer diameter and structure of the outer surface of the first middle layer connecting pipe 332, the first inner layer connecting pipe 333, and the first inner layer expanding tube 323 are fixed and will not change.
  • the medium delivery device is used to inject liquid into the first outer layer lumen 340, the middle layer lumen 350 and the inner layer lumen 360, and to extract the first outer layer lumen 340, the middle layer respectively Liquid in the lumen 350 and the inner lumen 360.
  • a guide wire may be provided in the inner lumen 360.
  • the first outer layer valve 510, the middle layer valve 520 and the first inner layer valve are respectively disposed between the first outer layer lumen 340 and the medium delivery device, and between the middle layer lumen 350 and the medium delivery device Between the layer lumen 360 and the medium delivery device.
  • the fixing member 370 is fixedly arranged on the outer surface of the first outer layer connecting pipe 331 in the connecting pipe 330.
  • the fixing member 370 is used to fix the fixing ear 110 in the bracket 100.
  • the fixing ear 110 in the stent 100 is first fixed to the fixing member 370, and then the sheath 210 is gradually moved to the distal end, so that the sheath 100 is gradually pressed by the sheath 210 to the first outer portion of the support catheter 320 Layer expansion tube 321 on the outer surface.
  • the fixing member 370 may also be fixedly disposed on the outer surface of the first outer expansion tube 321 in the support catheter 320.
  • the fixing member 370 includes a plurality of grooves, and the fixing ears 110 in the bracket 100 can be fixed in the grooves.
  • the material of the fixing member 370 is a metal material or a polymer material.
  • the handle 400 may be any one of a manual handle 400, an electric handle 400, or an electric manual hybrid drive handle 400.
  • FIG. 7 is a schematic structural view of a stent delivery device loaded with a stent 100 in Embodiment 1 of the present invention
  • FIG. 8 is a partially enlarged schematic view of the stent delivery device and stent 100 in FIG. 7, and
  • FIG. 9 is the present invention.
  • Another structural schematic diagram of the stent delivery device loaded with the stent 100 in the first embodiment, FIG. 10 is the support in FIG. 9
  • a partial enlarged schematic diagram of the rack conveying device and the bracket 100 Referring to FIGS. 7 to 10, the process of loading the rack 100 into the rack conveying device is as follows:
  • the two fixing lugs 110 of the stent 100 are caught in the grooves of the fixing member 370, the stent 100 is stabilized by an auxiliary loading tool, and the sheath 210 is driven to move distally, so that the outflow tract of the stent 100 is sheathed
  • the tube 210 is pressed and gripped.
  • the inflow channel of the stent 100 is pressed by the sheath tube 210 until the sheath tube 210 completely surrounds the stent 100, and at the same time, the distal end of the stent 100 is pressed against the end surface of the connector 310 ( The end face of the large end of the tapered head), so far, the stent 100 is clamped by the sheath 210 on the outer surface of the first outer expansion tube 321 in the support catheter 320, in this case, the first intermediate expansion tube 322 and The first outer layer expansion tubes 321 are all in a folded state.
  • the medium is injected into the inner catheter 300 to inflate the inner catheter 300 to the expanded state to adjust the form of the stent 100 held in the lumen of the sheath 210.
  • the medium liquid or gas
  • the medium delivery device is injected into the middle layer lumen 350 through the middle layer valve 520 through the medium delivery device, and the pressure of the medium is maintained at the first pressure state, so that the first middle layer expansion tube 322 is under the action of the medium Inflate to the expanded state, so that the first outer expansion tube 321 is expanded by the first intermediate expansion tube 322, so that the wall of the first outer expansion tube 321 conforms to the stent 100 held in the lumen of the sheath tube 210
  • the inner wall of the stent further distributes the stent 100 evenly within the lumen of the sheath 210.
  • FIGS. 9 and 10 for schematic diagrams of the first outer layer expansion tube 321 and the first middle layer expansion tube 322 after expansion.
  • the outer diameter of the outer surface of the first outer layer expansion tube 321 in the expanded state is greater than the outer diameter of the sheath tube 210, and the outer surface of the first middle layer expansion tube 322
  • the outer diameter of the surface in the expanded state is smaller than the inner diameter of the sheath 210.
  • the stent 100 is compressed in the lumen of the sheath 210, so that only the first intermediate expansion tube 322 can be expanded to the expanded state, and the first outer The layer expansion tube 321 is in a folded state.
  • the liquid in the middle layer lumen 350 may be withdrawn, so that the walls of the middle layer lumen 350 and the first outer layer lumen 340 are restored to the original state, even if the first middle layer expansion tube 322 is restored to the folded state .
  • FIG. 11 is a schematic structural view of the stent 100 after being released from the sheath 210 in Embodiment 1 of the present invention
  • FIG. 12 is an embodiment of the present invention
  • FIG. 13 is a schematic structural diagram of a stent 100 after being released from a sheath 210 in a heart.
  • FIG. 13 is a schematic structural diagram of another stent 100 after being released from a sheath 210 in the first embodiment of the present invention.
  • FIG. 14 is the present invention.
  • the process of implanting the stent 100 into the lesion through the stent delivery device includes:
  • the distal end of the stent delivery device enters the human body from the puncture port and follows the femoral vein or artery (aortic valve replacement through the femoral artery access, mitral valve, Tricuspid valve replacement through the vascular access of the femoral vein), the distal end of the stent delivery device is delivered to the diseased annulus, in this case, the stent 100 is clamped in the sheath 210, the first intermediate expansion tube 322 And the first outer layer expansion tube 321 are in a folded state.
  • the entire outer tube assembly 200 is moved to the proximal end by driving the handle 400, and release begins The stent 100 until the stent 100 is fully released to the designated position and disengaged from the stent delivery device. Specifically, during the movement of the sheath tube 210 toward the proximal end of the sheath tube 210, the inflow channel of the stent 100 is first released.
  • the outflow channel of the stent 100 is slowly released until the sheath
  • the distal end of the tube 210 moves to the fixing member 370 to expose the groove of the fixing member 370, so that the stent 100 is completely released from the sheath 210.
  • the stent 100 is released from the sheath 210, and both the first middle expansion tube 322 and the first outer expansion tube 321 are in a folded state.
  • FIGS. 11 and 12 for a schematic diagram of the stent 100 after being released from the sheath 210.
  • a medium is injected into the inner catheter 300 to inflate the first outer expansion tube 321 to the expanded state to adjust the shape of the released stent 100 (the stent is in the expanded state).
  • a medium liquid or gas, the liquid may be a liquid with a developing function
  • the pressure of the medium is maintained at the first Two pressure states, so that the first outer layer expansion tube 321 expands to the expanded state under the action of the medium, so that the wall of the first outer layer expansion tube 321 conforms to the inner wall of the stent 100 after release, passes through the first outer
  • the wall of the multi-layer expansion tube 321 provides radial support to the stent 100, and assists the stent 100 to restore its shape (when the stent 100 is a memory alloy stent 100, the stent 100 can restore the memory shape), so that the circumferential direction of the stent 100 can be more
  • the liquid in the first outer layer lumen 340 may be pumped back, thereby restoring the wall of the first outer layer lumen 340 To the initial state, in this case, the first outer layer expansion tube 321 and the first middle layer expansion tube 322 return to the folded state.
  • the stent delivery device is withdrawn. Specifically, the sheath 210 is driven to move distally first, so that the connector 310 and the sheath 210 are smoothly connected together. Then, through the handle 400, the outer tube assembly 200, the support tube 320, the connection tube 330, etc. are withdrawn from the human body.
  • the stent delivery device in this embodiment may also inject the medium into the first outer layer lumen 340 through the medium delivery device via the first outer layer valve 510, and The medium can be injected into the middle layer lumen 350 via the middle layer valve 520 through the medium delivery device to expand the first outer layer lumen 340 and the middle layer lumen 350.
  • This embodiment also provides a stent loading method for loading the stent 100 in the stent delivery device of the first embodiment.
  • the bracket loading method includes:
  • the stent 100 is pressed onto the outer surface of the inner catheter 300 through the sheath 210.
  • a medium is injected into the inner catheter 300 to inflate the inner catheter 300 to an expanded state to adjust the form of the stent 100 held in the lumen of the sheath 210.
  • the medium is injected into the inner catheter 300 to inflate the inner catheter 300 to an expanded state to adjust the shape of the stent 100 held in the lumen of the sheath 210.
  • the medium delivery device passes through the intermediate valve 520 to A medium is injected into the middle layer lumen 350 to expand the first middle layer expansion tube 322 to an expanded state under the action of the medium, thereby expanding the first outer layer expansion tube 321 through the first middle layer expansion tube 322 to cause the first outer layer
  • the tube wall of the expansion tube 321 fits against the inner wall of the stent 100 held in the lumen of the sheath tube 210, and the shape of the stent 100 held in the lumen of the sheath tube 210 is adjusted under the action of the injected medium.
  • the stent delivery device in this embodiment because the sheath tube 210 is sleeved on the outer surface of the support catheter 320, and the support catheter 320 is used to expand and hold the stent 100 in the lumen of the sheath tube 210, And the outer diameter of the outer surface of the first middle expansion tube 322 in the expanded state is smaller than the inner diameter of the sheath tube 210.
  • the stent 100 can be expanded through the support catheter 320, that is, the first outer layer expansion tube 322 is expanded to the expanded state to expand the first outer layer expansion tube 321 , And the tube wall of the first outer layer expansion tube 321 is fitted to the inner wall of the stent 100 that is pressed and held in the lumen of the sheath tube 210, and the liquid in the middle layer lumen 350 can be adjusted to be pressed and held in the sheath tube
  • the shape of the stent 100 in the lumen of 210 can reduce the phenomenon of uneven stress of the stent 100 held in the lumen of the sheath 210 and improve
  • the circumferential uniformity of the stent 100 reduces the phenomenon of inward depression of the stent 100, which improves the loading uniformity of the stent 100, thereby reducing the distortion and indentation of the stent 100 during the release process due to the above phenomenon. Affecting the release quality, damaging
  • the support catheter 320 is used to expand and clamp the stent 100 held in the lumen of the sheath tube 210, and
  • the outer diameter of the outer surface of the first outer expansion tube 321 in the expanded state is larger than the outer diameter of the sheath tube 210.
  • the first outer expansion tube 321 can be expanded to an expanded state, and the tube wall of the first outer expansion tube 321 can be fitted to the one released from the sheath 210
  • the inner wall of the stent 100 can be squeezed by the liquid in the first outer lumen 340 to adjust the shape of the stent 100 after release, so that the stent 100 can be more evenly distributed in the circumferential direction after release to improve the quality of the stent 100 release , To better play the function of the bracket 100.
  • the stent delivery device in this embodiment can determine whether the shape of the stent 100 needs to be adjusted according to the immediate surgical result, that is, whether It is necessary to expand the first outer expansion tube 321 to the expanded state to adjust the shape of the stent 100. If severe calcification occurs, it is difficult to self-expand and expand by the stent 100, or the stent 100 is not stretched to the desired level under complex anatomical conditions, etc.
  • the shape of the stent 100 can be adjusted by directly expanding the first outer expansion tube 321 to the expanded state without removing the stent delivery device from the human body, and then delivering the balloon kit to the human body Adjusting the shape of the stent 100 can save operation time and simplify operation steps, and reduce the risk that the operation time is too long and the operation steps are cumbersome, so that the vital signs of the patient are unstable and accidents occur.
  • first outer layer expansion tube 321 and the first middle layer expansion tube 322 are in a folded state
  • first outer layer expansion tube 321 and the first middle layer expansion tube 322 are in In the initial state, that is, in this initial state, the outer surfaces of the first outer layer expansion tube 321 and the first middle layer expansion tube 322 are folded, and neither the first outer layer lumen 340 nor the middle layer lumen 350 is filled with medium.
  • the filled medium is not enough to make the outer surface of the first outer layer expansion tube 321 fit the inner wall of the stent 100, and the outer surface of the first outer layer expansion tube 321 in the expanded state
  • the outer diameter is greater than the outer diameter in the initial state, and the outer diameter of the outer surface of the first intermediate expansion tube 322 in the expanded state is greater than the outer diameter in the initial state.
  • FIG. 15 is a schematic cross-sectional view of the stent delivery device in the second embodiment of the present invention in a contracted state
  • FIG. 16 is a schematic cross-sectional view of the stent delivery device of FIG. 15 along line BB
  • FIG. 17 is the present invention
  • the difference between the stent delivery device in the present embodiment and the stent delivery device in the first embodiment is that, in this embodiment, the stent delivery device
  • the support catheter 710 and the connection catheter 720 are different from the support catheter 320 and the connection catheter 330 in the stent delivery device in the first embodiment.
  • the stent delivery device includes a handle 800, an outer tube assembly 600, and an inner catheter 700
  • the inner catheter 700 includes a connection head 730, a support catheter 710, a connection catheter 720 and a fixing member which are sequentially connected from the distal end to the proximal end
  • the outer tube assembly 600 includes a sheath tube 610 and an outer tube 620, the sheath tube 610 is fixedly connected to the outer tube 620, and the outer tube 620 is connected to the handle 800.
  • the sheath tube 610 is used to press and hold the stent 100.
  • the outer tube 620 can be specifically connected to the movable part in the handle 800, so that the movable part in the handle 800 can be driven to move, and then the outer tube assembly 600 can be driven in the support catheter 710 and the movable part in the handle 800.
  • the outer surface of the connection pipe 720 moves along the axial direction of the support pipe 710 and the connection pipe 720.
  • the support catheter 710 and the connection catheter 720 may be accommodated in the lumen of the outer tube assembly 600.
  • the distal end of the support catheter 710 is connected to the connector 730, the proximal end of the support catheter 710 is connected to the distal end of the connection catheter 720, and the support catheter 710 is used to expand and hold the sheath 610 In the stent in the lumen, the proximal end of the connecting catheter 720 is fixedly connected to the handle 800.
  • the support catheter 710 includes a second outer layer expansion tube 711 and a second inner layer expansion tube 712.
  • the second outer layer expansion tube 711 is sleeved on the outer surface of the second inner layer expansion tube 712.
  • the distal ends of the second outer layer expansion tube 711 and the second inner layer expansion tube 712 are fixedly connected to the connector 730, and the proximal ends of the second outer layer expansion tube 711 and the second inner layer expansion tube 712 It is fixedly connected to the distal end of the connection catheter 720.
  • the second outer layer expansion tube 711 has a contracted state, a first expanded state, and a second expanded state. Said The outer surface of the second outer layer expansion tube 711 is not fully expanded or folded together in the contracted state, and expands into a balloon shape in the first and second expanded states. The outer diameter and structure of the second inner layer expansion tube 712 will not change with different working conditions.
  • the outer diameter of the outer surface of the second outer expansion tube 711 in the second expanded state is greater than the outer diameter of the sheath tube 610, and the outer surface of the second outer expansion tube 711 is at the first
  • the outer diameter in the expanded state is smaller than the inner diameter of the sheath 610.
  • the outer diameter of the outer surface of the second outer layer expansion tube 711 in the first expanded state ranges from 4 mm to 13 mm, and the outer surface of the second outer layer expansion tube 711 is in the second expanded state
  • the value range of the outer diameter of the bottom is between 16mm and 40mm.
  • the connecting pipe 720 includes a second outer layer connecting pipe 721 and a second inner layer connecting pipe 722.
  • the second outer layer connecting pipe 721 is sleeved on the outer surface of the second inner layer connecting pipe 722.
  • the second outer layer connecting tube 721 is connected to the second outer layer expanding tube 711, and the second inner layer connecting tube 722 is connected to the second inner layer expanding tube 712.
  • the second outer connecting pipe 721 and the second inner connecting pipe 722 are fixedly connected to the handle 800.
  • the second outer layer connecting tube 721 and the second outer layer expanding tube 711 and the second inner layer connecting tube 722 and the second inner layer expanding tube 712 form a second outer layer lumen 750
  • the lumen of the second inner layer connecting catheter 722 and the second inner layer expansion tube 712 is the second inner layer lumen 760.
  • the outer diameter and the structure of the second outer layer connecting pipe 721 and the second inner layer connecting pipe 722 and the second inner layer expansion tube 712 will not change with different working states .
  • the materials of the second outer layer connection conduit 721 and the second inner layer connection conduit 722 may be one of a polymer material and a high molecular/metal composite material.
  • the second outer-layer connecting duct 721 and the second inner-layer connecting duct 722 are connected to the fixing part in the handle 800 to limit the six degrees of freedom of the supporting duct 710 and the connecting duct 720. Even if the support duct 710 and the connecting duct 720 are fixed relative to the handle 800, the risk of displacement of the stent loaded on the delivery device is reduced.
  • the second inner layer expansion tube 712 and the second inner layer connection catheter 722 may be woven from a tube of uniformly distributed material, or may be made of two tubes separately manufactured and fixedly connected, wherein, two tubes The diameter can be the same.
  • the second outer layer expansion tube 711 and the second outer layer connecting pipe 721 are made of different materials, and then fixedly connected. The purpose of using different materials is to make the second outer expansion tube 711 close In the contracted state, it can be folded or in an incompletely expanded state. In the first expanded state and the second expanded state, it can be inflated into a balloon shape.
  • the medium delivery device is used to inject liquid into the second outer layer lumen 750 and the second inner layer lumen 760, respectively, and to extract the second outer layer lumen 750 and the second inner layer respectively Liquid in the lumen 760.
  • a guide wire may be provided in the second inner layer lumen 760.
  • the second outer layer valve 810 and the second inner layer valve 820 are respectively disposed between the second outer layer lumen 750 and the medium delivery device and the second inner layer lumen 760 and the medium delivery device.
  • the second outer layer expansion tube 711 is an elastomer, and the second outer layer expansion tube 711 uses a highly elastic material, for example, a thermoplastic elastomer (TPE), so that the second outer layer The layer expansion tube 711 can realize the first expansion state and the second expansion state.
  • a medium is injected into the inner catheter 700 to inflate the inner catheter 700 to the first expanded state to adjust the shape of the stent held in the lumen of the sheath 610
  • the steps are different from the first embodiment.
  • a medium is injected into the inner catheter 700 to expand the inner catheter 700 to an expanded state to adjust the shape of the stent that is held in the lumen of the sheath tube 610, specifically including:
  • the medium (liquid or gas) is injected into the second outer layer lumen 750 through the second outer layer valve 810 through the medium delivery device, and the pressure of the medium is maintained at the first pressure state, so that the second outer layer tube
  • the cavity 750 expands to the first expanded state under the action of the medium, so that the wall of the second outer expansion tube 711 fits against the inner wall of the stent held in the lumen of the sheath 610 to adjust the pressure to the sheath
  • the shape of the stent in the lumen of 610 is injected into the second outer layer lumen 750 through the second outer layer valve 810 through the medium delivery device, and the pressure of the medium is maintained at the first pressure state, so that the second outer layer tube
  • the cavity 750 expands to the first expanded state under the action of the medium, so that the wall of the second outer expansion tube 711 fits against the inner wall of the stent held in the lumen of the sheath 610 to adjust the pressure to the sheath
  • the second outer layer expansion tube 711 can be made Expand to the first expanded state, but not to the second expanded state.
  • a medium is injected into the inner catheter 700 to expand the second outer expansion tube 711 to the second expanded state to adjust the released stent
  • the form is different from the first embodiment.
  • the step of injecting a medium into the inner catheter 700 to expand the second outer expansion tube 711 to the second expanded state to adjust the shape of the released stent specifically includes:
  • the wall of the second outer expansion tube 711 provides radial support to the stent to assist the restoration of the shape of the stent (when the stent is a memory alloy stent, the stent can restore the memory shape), so that the circumferential distribution of the stent can be more evenly distributed after the stent is released , Better to play the function of the bracket.
  • This embodiment also provides a stent loading method for loading a stent in the stent delivery device in Embodiment 2.
  • the bracket loading method includes:
  • the medium is injected into the inner catheter 700 to expand the inner catheter 700 to the second expanded state to adjust the shape of the released stent.
  • the medium is injected into the inner catheter 700 to inflate the inner catheter 700 to the second expanded state to adjust the shape of the released stent.
  • the medium delivery device passes through the second outer layer valve 810 to the second outer layer Inject the medium into the lumen 750 to expand the second outer expansion tube 711 to the second expanded state under the action of the medium, so that the wall of the second outer expansion tube 711 fits the shape of the released stent, and Adjust the shape of the lumen of the released stent under the action of the injected medium.
  • the stent delivery device in this embodiment because the sheath tube 610 is sleeved on the outer surface of the support catheter 710, and the support catheter 710 is used to expand and hold the stent in the lumen of the sheath tube 610, and The outer diameter of the outer surface of the second outer expansion tube 711 in the first expanded state is smaller than the inner diameter of the sheath tube 610.
  • the second outer expansion tube 711 can be inflated, and the tube wall of the second outer expansion tube 711 can be pressed against the sheath tube 610
  • the stent can be improved Release success rate
  • the support catheter 710 is used to expand and hold the stent held in the lumen of the sheath tube 610, and The second outer layer expansion
  • the outer diameter of the outer surface of the tension tube 711 in the second expanded state is larger than the outer diameter of the sheath tube 610.
  • the second outer-layer expansion tube 711 can be expanded to the second expanded state, and the tube wall of the second outer-layer expansion tube 711 can be fitted and released from the sheath tube 610
  • the inner wall of the stent, under the squeeze of the liquid in the second outer lumen 750, can adjust the shape of the stent after release, so that the stent can be more evenly distributed in the circumferential direction after release, to improve the quality of the stent release, more Make good use of the bracket.
  • the stent delivery device in this embodiment can determine whether the shape of the stent needs to be adjusted according to the immediate surgical result, that is, whether the stent needs to be expanded.
  • An outer layer of expansion tube is expanded to adjust the shape of the stent.
  • the second outer layer expansion tube 711 when the second outer layer expansion tube 711 is in a contracted state, it can be understood that the second outer layer expansion tube 711 is in an initial state, that is, in this initial state, the second outer layer
  • the outer surface of the layer expansion tube 711 is folded or in an unexpanded state, and the second outer layer lumen 750 is not filled with medium, or partially filled with medium, but the filled medium is not enough to make the second outer layer expansion tube 711
  • the outer surface is in conformity with the inner wall of the stent, and the outer diameter of the outer surface of the second outer expansion tube 711 in the first expanded state is larger than the outer diameter in the initial state.
  • proximal end and distal end in the above-mentioned embodiments refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although the “proximal end” and The “distal end” is not restrictive, but the “proximal end” usually refers to the end of the medical device that is close to the doctor during normal operation, and the “distal end” generally refers to the end that first enters the patient.
  • the term “or” in the above embodiments is generally used with the meaning including “and/or”, unless explicitly stated otherwise.
  • two ends refer to the near end and the far end.

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Abstract

一种支架输送装置，包括鞘管（210）和内导管（300），鞘管（210）套设在内导管（300）外，内导管具有第一扩张状态，在第一扩张状态下，支架（100）可压握在鞘管（210）内，内导管（300）呈球囊状，内导管（300）的外表面贴合压握状态下的支架（100）的内壁，且内导管的外径小于鞘管（210）的内径。通过内导管扩张支架，并调整压握在鞘管内的支架的形态，可减小压握在鞘管内的支架出现应力不平均的现象，改善支架的装载均匀性，减少支架在释放过程中出现的扭曲或内陷。

Description

支架输送装置和支架装载方法
技术领域
[0001] 本发明涉及医疗器械技术领域， 特别涉及一种支架输送装置和支架装载方法。
背景技术
[0002] 随着社会经济的发展和人口的老龄化， 瓣膜性心脏病的发病率明显增加， 研究 表明 75岁以上的老年人群瓣膜性心脏病发病率高达 13.3%。 目前， 采用传统外科 手术治疗仍是重度瓣膜病变患者的首选治疗手段， 但是对于高龄、 合并多器官 疾病、 有开胸手术史以及心功能较差的患者来说， 传统外科手术的风险大、 死 亡率高， 部分患者甚至没有手术的机会。 经导管心脏瓣膜的置换术具有无需开 胸、 创伤小、 患者恢复快等优点， 受到了专家学者的广泛关注。
发明概述
技术问题
[0003] 就现有技术而言， 由于支架装载进较小内径的鞘管时会出现应力不平均的现象 ， 特别是对于具有很强的径向支撑力的自膨式支架而言， 装载进较小内径的鞘 管时会出现应力不平均的现象更为严重， 导致支架在鞘管的管腔内周向均匀性 变差， 甚至会出现支架向内凹陷的现象， 使支架装载均匀性降低。 这一问题很 难避免， 在不透明的鞘管中更不易被发现， 致使支架实际释放过程中会出现扭 曲、 内陷， 严重影响释放质量， 损伤周边组织， 易使瓣膜疲劳， 甚至损坏输送 装置、 影响输送系统回撤。
问题的解决方案
技术解决方案
[0004] 本发明的目的在于提供一种支架输送装置和支架装载方法， 以解决支架装载到 5见有的支架输送装置中后装载均匀性不高的问题， 以及使用现有的支架装载方 法装载支架易使支架的装载均匀性不高的问题。
[0005] 为解决上述技术问题， 本发明提供一种支架输送装置， 其用于输送支架， 包括 鞘管和内导管， 所述鞘管套设在所述内导管外， 所述内导管具有第一扩张状态 ， 在所述第一扩张状态下， 所述支架可压握在所述鞘管内， 所述内导管呈球囊 状， 所述内导管的外表面贴合压握状态下的所述支架的内壁， 且所述内导管的 外径小于所述鞘管的内径。
[0006] 可选的， 所述内导管包括外层扩张管和外层连接导管， 所述外层连接导管的远 端与所述外层扩张管连接， 所述支架套设在所述外层扩张管的外表面上， 在所 述第一扩张状态下， 所述外层扩张管呈球囊状。
[0007] 可选的， 所述内导管还具有第二扩张状态； 在所述第二扩张状态下， 所述外层 扩张管呈球囊状， 所述支架位于所述鞘管外且处于扩张状态， 所述外层扩张管 的外表面贴合所述支架的内壁， 所述外层扩张管的外径大于所述鞘管的外径。
[0008] 可选的， 所述内导管还具有一初始状态， 所述内导管在所述初始状态下的外径 小于在所述第一扩张状态下的外径。
[0009] 可选的， 所述内导管还包括内层扩张管、 内层连接导管、 连接头和固定件， 所 述支架输送装置还包括手柄， 所述外层扩张管套设在所述内层扩张管的外表面 上， 所述外层连接导管套设在所述内层连接导管的外表面上， 所述内层连接导 管的远端与所述内层扩张管连接， 所述外层扩张管的远端和所述内层扩张管的 远端与所述连接头固定连接， 所述外层连接导管的近端和所述内层连接导管的 近端与所述手柄固定连接， 所述固定件固定设置在所述外层扩张管和 /或外层连 接导管的外表面上， 所述固定件用于固定所述支架， 所述手柄用于驱动所述鞘 管在所述内导管的外表面上沿着所述内导管的轴向移动。
[0010] 可选的， 所述外层扩张管和所述外层连接导管与所述内层扩张管和所述内层连 接导管围成第一外层管腔， 所述内导管还包括第一外层阀门和介质输送装置， 所述第一外层阀门设置在所述第一外层管腔与所述介质输送装置之间， 所述介 质输送装置用于经过所述第一外层阀门向所述第一外层管腔中注入介质。
[0011] 可选的， 所述内导管包括外层扩张管、 外层连接导管、 中层扩张管和中层连接 导管， 所述外层连接导管的远端与所述外层扩张管连接， 所述中层连接导管的 远端与所述中层扩张管连接， 所述外层扩张管和外层连接导管分别套设在所述 中层扩张管和所述中层连接导管的外表面上， 所述支架套设在所述外层扩张管 的外表面上， 在所述第一扩张状态下， 所述中层扩张管呈球囊状， 所述外层扩 张管呈折叠状。
[0012] 可选的， 所述内导管还具有第二扩张状态， 在所述第二扩张状态下， 所述外层 扩张管呈球囊状， 所述支架位于所述鞘管外且处于扩张状态， 所述外层扩张管 的外表面贴合所述支架的内壁， 所述外层扩张管在所述第二扩张状态下的外径 大于所述鞘管的外径。
[0013] 可选的， 所述内导管还具有一初始状态， 在所述初始状态下， 所述外层扩张管 和所述中层扩张管呈折叠状， 所述中层扩张管在所述第一扩张状态下的外径大 于所述外层扩张管在所述初始状态下的外径。
[0014] 可选的， 所述内导管还包括内层扩张管、 内层连接导管、 连接头和固定件， 所 述支架输送装置还包括手柄， 所述中层扩张管套设在所述内层扩张管的外表面 上， 所述中层连接导管套设在所述内层连接导管的外表面上， 所述内层连接导 管的远端与所述内层扩张管连接， 所述外层扩张管、 所述中层扩张管和所述内 层扩张管的远端与所述连接头固定连接， 所述外层连接导管、 所述中层连接导 管和所述内层连接导管的近端与所述手柄固定连接， 所述固定件固定设置在所 述外层扩张管和 /或所述外层连接导管的外表面上， 所述固定件用于固定所述支 架， 所述手柄用于驱动所述鞘管在所述内导管的外表面上沿着所述内导管的轴 向移动。
[0015] 可选的， 所述外层扩张管和所述外层连接导管与所述中层扩张管和所述中层连 接导管围成第二外层管腔， 所述中层扩张管和所述中层连接导管与所述内层扩 张管和所述内层连接导管围成中层管腔， 所述内导管还包括第二外层阀门、 中 层阀门和介质输送装置， 所述第二外层阀门设置在所述第二外层管腔与所述介 质输送装置之间， 所述中层阀门设置在所述中层管腔与所述介质输送装置之间 ， 所述介质输送装置用于经过所述中层阀门向所述中层管腔中注入介质， 以及 经过所述第二外层阀门向所述第二外层管腔中注入介质。
[0016] 本发明还提供一种上述的支架输送装置的支架装载方法， 包括： 将套设在所述 内导管的外表面上的所述支架压握在所述鞘管的管腔内； 向所述内导管的管腔 内注入介质， 并使所述内导管膨胀至所述第一扩张状态， 以使所述内导管呈球 囊状， 并使所述内导管的外表面贴合压握状态下的所述支架的内壁。 [0017] 可选的， 还包括释放所述内导管的管腔内的介质， 以使所述内导管处于初始状 态。
[0018] 本发明提供的一种支架输送装置和支架装载方法， 具有以下有益效果：
[0019] 由于将套设在内导管的外表面上的支架压握在鞘管的管腔内， 并且在第一扩张 状态下， 所述内导管呈球囊状， 所述内导管的外表面贴合压握状态下的所述支 架的内壁， 且所述内导管的外径小于所述鞘管的内径， 因此， 可通过内导管扩 张支架， 进而调整压握在鞘管内的支架的形态， 从而可减小压握在鞘管内的支 架出现应力不平均的现象， 改善支架的周向均匀性， 减小支架向内凹陷的现象 ， 即可改善支架的装载均匀性， 进而减少支架由于出现上述现象而导致在释放 过程中出现的扭曲、 内陷， 从而影响释放质量， 损伤周边组织， 影响瓣膜疲劳 ， 甚至损坏输送系统， 影响回撤功能的风险， 即可改善支架释放成功率。
发明的有益效果
对附图的简要说明
附图说明
[0020] 图 1是支架的结构示意图；
[0021] 图 2是本发明实施例一中的支架输送装置的结构示意图；
[0022] 图 3是本发明实施例一中的支架输送装置中的内导管扩张后的结构示意图； [0023] 图 4是本发明实施例一中的支架输送装置中内导管在折叠状态下的剖面示意图
[0024] 图 5是图 4中的支架输送装置沿 A-A线的剖面示意图；
[0025] 图 6是本发明实施例一中的支架输送装置中内导管中的第一中层扩张管在扩张 状态下的剖面示意图；
[0026] 图 7为本发明实施例一中的支架输送装置中装载有支架的一种结构示意图； [0027] 图 8为图 7中的支架输送装置和支架的部分放大示意图；
[0028] 图 9为本发明实施例一中的支架输送装置中装载有支架的另一种结构示意图； [0029] 图 10为图 9中的支架输送装置和支架的部分放大示意图；
[0030] 图 11为本发明实施例一中支架从鞘管中释放后的一种结构示意图；
[0031] 图 12为本发明实施例一中支架在心脏中从鞘管中释放后的一种结构示意图； [0032] 图 13为本发明实施例一中支架从鞘管中释放后的另一种结构示意图；
[0033] 图 14为本发明实施例一中支架在心脏中从鞘管中释放后的另一种结构示意图;
[0034] 图 15是本发明实施例二中的支架输送装置在收缩状态下的剖面示意图；
[0035] 图 16是图 15中的支架输送装置沿 B-B线的剖面示意图；
[0036] 图 17是本发明实施例二中的支架输送装置在第一扩张状态下的剖面示意图。
[0037] 附图标记说明：
[0038] 100-支架； 110-固定耳； 120-流入道结构； 130-流出道结构；
[0039] 实施例一中的附图标记说明：
[0040] 200 -外管组件； 210-鞘管； 220-外管；
[0041] 300 -内导管； 310 -连接头；
[0042] 320 -支撑导管； 321 -第一外层扩张管； 322 -第一中层扩张管； 323 -第一内层扩 张管；
[0043] 330 -连接导管； 331-第一外层连接导管； 332 -第一中层连接导管； 333 -第一内 层连接导管；
[0044] 340 -第一外层管腔； 350 -中层管腔； 360 -内层管腔；
[0045] 370 -固定件；
[0046] 400-手柄；
[0047] 510 -第一外层阀门；
[0048] 520 -中层阀门；
[0049] 实施例二中的附图标记说明：
[0050] 600 -外管组件； 610-鞘管； 620-外管；
[0051] 700 -内导管；
[0052] 710 -支撑导管； 711 -第二外层扩张管； 712 -第二内层扩张管；
[0053] 720 -连接导管； 721-第二外层连接导管； 722 -第二内层连接导管；
[0054] 730 -连接头； 740 -固定件； 750 -第二外层管腔； 760 -第二内层管腔；
[0055] 800-手柄； 810 -第二外层阀门； 820 -第二内层阀门。
发明实施例
本发明的实施方式 [0056] 图 1是支架 100的结构示意图， 如图 1所示， 所述支架 100包括两个固定耳 110以 及呈网管状的流入道结构 120和流出道结构 130， 所述流入道结构 120和流出道结 构 130连接， 两个所述固定耳 110与所述流出道结构 130连接。
[0057] 支架 100通常需要先装载到支架输送装置中， 然后经由支架输送装置输送到病 灶处， 之后由支架输送装置将支架 100释放到相应的位置， 从而将支架 100植入 到相应位置， 以对病灶进行治疗。 在支架 100释放到相应的位置后， 有可能还需 要再采用支架输送装置或者其他的医疗器械调整支架 100的位置和形态， 以便于 充分发挥支架 100的治疗效果。
[0058] 支架 100装载到支架输送装置中后， 通常由支架输送装置中的鞘管压握在内导 管上。 其中， 所述鞘管套设在所述支架 100的外表面上， 所述支架 100中的流入 道结构 120和流出道结构 130套设在所述内导管的外表面上， 所述支架 100的固定 耳 110固定在所述鞘管中。 在这种状态下， 所述支架 100处于压缩状态， 由于鞘 管的内径较小， 支架 100容易出现应力不平均的现象， 特别是对于具有很强的径 向支撑力的自膨式支架 100， 支架 100出现应力不平均的现象更为常见， 容易使 支架 100在鞘管的管腔内周向均匀性变差， 甚至会出现支架 100向内凹陷的现象 ， 使支架 100的装载均匀性降低。
[0059] 为了改善支架的装载均匀性， 本发明提供一种用于输送支架的支架输送装置。
所述支架输送装置包括内导管和鞘管。 所述鞘管套设在所述内导管的外表面上 ， 所述内导管用于扩张压握在所述鞘管的管腔内的支架。 由于鞘管套设在所述 内导管的外表面上， 并且内导管用于扩张压握在鞘管的管腔内的支架， 因此， 当鞘管将支架压握在内导管上后， 可通过内导管扩张支架， 从而可减小压握在 所述鞘管的管腔内的支架应力不平均的现象， 改善支架的周向均匀性， 减小支 架向内凹陷的现象， 即可改善支架装载均匀性， 进而减小支架由于出现上述现 象导致支架在释放过程中出现扭曲、 内陷， 从而影响释放质量， 损伤周边组织 ， 影响瓣膜疲劳， 甚至损坏输送系统， 影响回撤功能的风险， 即可改善支架释 放成功率。
[0060] 相应的， 本发明还提供一种支架装载方法， 当鞘管将支架压握在内导管上后， 所述支架装载方法通过内导管扩张压握在鞘管的管腔内的支架， 从而改善支架 装载均匀性， 进而改善支架释放成功率。
[0061] 以下结合附图和具体实施例对本发明提出的支架输送装置和支架装载方法作进 一步详细说明。 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。
[0062] 实施例一
[0063] 本实施例提供一种支架输送装置。 图 2是本发明实施例一中的支架输送装置的 结构示意图， 图 3是本发明实施例一中的支架输送装置中的内导管 300扩张后的 结构示意图， 图 4是本发明实施例一中的支架输送装置中内导管在折叠状态下的 剖面示意图， 图 5是图 4中的支架输送装置沿 A-A线的剖面示意图， 图 6是本发明 实施例一中的支架输送装置中内导管中的第一中层扩张管在扩张状态下的剖面 示意图， 参考图 2至图 6 , 所述支架输送装置包括外管组件 200、 内导管 300、 手 柄 400、 介质输送装置、 第一外层阀门 510、 中层阀门 520和第一内层阀门。 其中 ， 所述内导管 300包括从远端到近端依次连接的连接头 310、 支撑导管 320、 连接 导管 330和固定件 370。
[0064] 参考 4至图 6 , 所述外管组件 200套设在所述内导管 300的外表面上。 具体的， 所 述外管组件 200套设在所述支撑导管 320和 /或所述连接导管 330的外表面上， 且所 述手柄 400用于驱动所述外管组件 200在所述支撑导管 320和所述连接导管 330的 外表面上沿着支撑导管 320和所述连接导管 330的轴向移动。
[0065] 具体的， 所述外管组件 200包括鞘管 210和外管 220， 所述鞘管 210与所述外管 22 0固定连接， 所述外管 220与手柄 400连接。 所述鞘管 210用于压握并容置支架 100 。 所述外管 220具体可与手柄 400中的活动部件连接， 从而可通过驱动手柄 400中 的活动部件移动， 进而可通过手柄 400中的活动部件驱动外管 220和所述鞘管 210 在所述支撑导管 320和所述连接导管 330的外表面上沿着支撑导管 320和所述连接 导管 330的轴向移动。
[0066] 本实施例中， 外管组件 200可以被手柄 400驱动沿着支撑导管 320和所述连接导 管 330的轴向移动， 但不能绕着支撑导管 320和所述连接导管 330的轴向旋转， 以 降低因外管组件 200旋转使压握在外管组件 200中的支架 100变形导致支架 100释 放成功率降低的风险。
[0067] 参考图 4至图 6， 鞘管 210的内径和外径均大于外管 220的内径和外径， 以降低支 架输送装置将支架 100输送到病灶处的过程中对人体造成的影响。
[0068] 所述外管组件 200可采用金属材料、 高分子 /金属复合材料中的一种或者多种制 造。
[0069] 参考图 3至图 6 , 所述支撑导管 320和所述连接导管 330可容置在所述外管组件 20 0的管腔内。 所述支撑导管 320的远端与连接头 310连接， 所述支撑导管 320的近 端与所述连接导管 330的远端连接， 所述支撑导管 320用于扩张压握在所述鞘管 2 10的管腔内的支架 100, 所述连接导管 330的近端与所述手柄 400固定连接。
[0070] 参考图 4至图 6 , 所述支撑导管 320包括第一外层扩张管 321、 第一中层扩张管 32 2和第一内层扩张管 323。 所述第一外层扩张管 321套设在所述第一中层扩张管 32 2的外表面上， 所述第一中层扩张管 322套设在所述第一内层扩张管 323的外表面 上。 所述第一外层扩张管 321、 第一中层扩张管 322和第一内层扩张管 323的远端 与所述连接头 310固定连接， 所述第一外层扩张管 321、 第一中层扩张管 322和第 一内层扩张管 323的近端与所述连接导管 330的远端固定连接。
[0071] 所述第一外层扩张管 321和第一中层扩张管 322分别具有折叠状态和扩张状态。
所述第一外层扩张管 321的外表面在折叠状态下折叠， 在扩张状态下膨胀呈球囊 状。 所述第一中层扩张管 322的外表面在折叠状态下折叠， 在扩张状态下膨胀呈 球囊状。 所述第一内层扩张管 323的外径和结构不会随着不同的工作状态发生变 化。
[0072] 其中， 所述第一外层扩张管 321的外表面在扩张状态下的外径大于所述鞘管 210 的外径， 并且所述第一中层扩张管 322的外表面在扩张状态下的外径小于鞘管 21 0的内径。
[0073] 所述第一外层扩张管 321的外表面在扩张状态下的外径的取值范围在 16mm到 40 mm之间， 所述第一中层扩张管 322的外表面在扩张状态下的外径的取值范围在 4 mm至 13mm之间。
[0074] 所述第一内层扩张管 323的材料可为高分子材料、 高分子 /金属复合材料中的一 种。 所述第一中层扩张管 322和第一外层扩张管 321的材料可为高分子材料。 [0075] 所述连接头 310和支撑导管 320从远端到近端顺次连接。
[0076] 具体的， 所述连接头 310为锥形头， 锥形头的大端与支撑导管 320连接， 锥形头 的小端为自由端。 在其他的实施例中， 所述连接头 310还可以为其他的形状， 如 可为从连接头 310的远端到近端外径逐渐变大的渐变柱状结构。
[0077] 所述连接头 310优选采用流线型设计， 以减小连接头 310的移动阻力。 所述连接 头 310优选采用高分子材料。
[0078] 参考图 4至图 6 , 所述连接导管 330包括第一外层连接导管 331、 第一中层连接导 管 332和第一内层连接导管 333。
[0079] 所述第一外层连接导管 331套设在所述第一中层连接导管 332的外表面上， 所述 第一中层连接导管 332套设在所述第一内层连接导管 333的外表面上。 所述第一 外层连接导管 331的远端与所述第一外层扩张管 321连接， 第一中层连接导管 332 的远端与所述第一中层扩张管 322连接， 第一内层连接导管 333的远端与所述第 一内层扩张管 323连接。 所述第一外层连接导管 331、 第一中层连接导管 332和第 一内层连接导管 333的近端与所述手柄 400固定连接。 其中， 所述第一外层连接 导管 331和所述第一外层扩张管 321与所述第一中层连接导管 332和所述第一中层 扩张管 322围成第一外层管腔 340; 所述第一中层连接导管 332和所述第一中层扩 张管 322与所述第一内层连接导管 333与所述第一内层扩张管 323围成中层管腔 35 0； 所述第一内层连接导管 333和所述第一内层扩张管 323的内腔为内层管腔 360
[0080] 其中， 本实施例中， 所述第一外层连接导管 331、 第一中层连接导管 332和第一 内层连接导管 333的外径和结构不会随着不同的工作状态发生变化。
[0081] 所述第一外层连接导管 331、 第一中层连接导管 332和第一内层连接导管 333的 材料可为高分子材料、 高分子 /金属复合材料中的一种。
[0082] 具体的， 所述第一外层连接导管 331、 第一中层连接导管 332和第一内层连接导 管 333与所述手柄 400中的固定部件连接， 以限制支撑导管 320和连接导管 330的 六个自由度， 使得所述支撑导管 320和连接导管 330相对所述手柄 400固定， 从而 降低装载到输送装置上的支架 100移位的风险。
[0083] 第一内层扩张管 323与第一内层连接导管 333可以采用一根材质均匀分布的管材 织造而成， 也可以采用两根管材分开制造后固定连接而成， 其中， 两根管材的 直径可相同。 第一中层扩张管 322与第一中层连接导管 332由不同的材料制备， 然后固定连接而成。 第一外层扩张管 321与第一外层连接导管 331由不同的材料 制备， 然后固定连接而成。 使用不同的材料的目的在于， 使得第一外层扩张管 3 21、 第一中层扩张管 322在折叠状态下可以被折叠， 在扩张状态下可以膨胀呈球 囊状； 第一外层连接导管 331、 第一中层连接导管 332、 第一内层连接导管 333和 第一内层扩张管 323的外表面的外径和结构是固定的， 不会发生改变。
[0084] 所述介质输送装置用于分别向所述第一外层管腔 340、 中层管腔 350和内层管腔 360中注入液体， 以及分别抽出所述第一外层管腔 340、 中层管腔 350和内层管腔 360中的液体。 所述内层管腔 360中可设置导丝。
[0085] 所述第一外层阀门 510、 中层阀门 520和第一内层阀门分别设置在第一外层管腔 340与介质输送装置之间、 中层管腔 350与介质输送装置之间和内层管腔 360与介 质输送装置之间。
[0086] 所述固定件 370固定设置在所述连接导管 330中的第一外层连接导管 331的外表 面上。 所述固定件 370用于固定支架 100中的固定耳 110。 通常先将支架 100中的 固定耳 110固定在所述固定件 370上， 然后使鞘管 210逐渐向远端移动， 从而通过 鞘管 210逐渐将支架 100压握在支撑导管 320中的第一外层扩张管 321的外表面上 。 在其他实施例中， 所述固定件 370还可固定设置在所述支撑导管 320中的第一 外层扩张管 321的外表面上。 所述固定件 370包括多个凹槽， 支架 100中的固定耳 110可固定在所述凹槽中。 所述固定件 370的材质为金属材料或高分子材料的一 种。
[0087] 所述手柄 400可以采用手动手柄 400、 电动手柄 400或者电动手动混合驱动手柄 4 00中的任一种。
[0088] 以下说明将支架 100装载到支架输送装置以及通过支架输送装置将支架 100植入 到病灶处的过程。
[0089] 图 7为本发明实施例一中的支架输送装置中装载有支架 100的一种结构示意图， 图 8为图 7中的支架输送装置和支架 100的部分放大示意图， 图 9为本发明实施例 一中的支架输送装置中装载有支架 100的另一种结构示意图， 图 10为图 9中的支 架输送装置和支架 100的部分放大示意图， 参考图 7至图 10， 将支架 100装载到支 架输送装置的过程具体如下：
[0090] 首先， 通过驱动手柄 400使得外管组件 200整体向近端移动至露出固定件 370的 凹槽。
[0091] 其次， 将支架 100的两个固定耳 110卡在固定件 370的凹槽内， 借助辅助装载工 具稳定支架 100, 驱动鞘管 210向远端移动， 先使支架 100的流出道被鞘管 210压 握， 随着鞘管 210不断移动， 支架 100的流入道被鞘管 210压握， 直至鞘管 210完 全包裹住支架 100, 同时使支架 100的远端抵住连接头 310的端面 （锥形头的大端 的端面） ， 至此， 支架 100被鞘管 210压握在支撑导管 320中的第一外层扩张管 32 1的外表面上， 这种情况下， 第一中层扩张管 322和第一外层扩张管 321均处于折 叠状态。 支架 100被鞘管 210压握在支撑导管 320中的第一外层扩张管 321的外表 面上的示意图可参考图 7和图 8。
[0092] 然后， 向内导管 300中注入介质， 以使内导管 300膨胀至扩张状态， 以调整压握 在鞘管 210的管腔内的支架 100的形态。 具体的， 通过介质输送装置经由中层阀 门 520向中层管腔 350中注入介质 （液体或者气体） ， 并使介质的压力维持在第 一压力状态， 以使第一中层扩张管 322在介质的作用下膨胀至扩张状态， 从而通 过第一中层扩张管 322使第一外层扩张管 321膨胀， 以使第一外层扩张管 321的管 壁贴合压握在鞘管 210的管腔内的支架 100的内壁， 进而使支架 100在鞘管 210的 管腔内均匀分布。 第一外层扩张管 321和第一中层扩张管 322膨胀后的示意图可 参考图 9和图 10。 在第一中层扩张管 322膨胀的过程中， 由于第一外层扩张管 321 的外表面在扩张状态下的外径大于所述鞘管 210外径， 并且所述第一中层扩张管 322的外表面在扩张状态下的外径小于鞘管 210的内径， 此外， 支架 100压握在鞘 管 210的管腔内， 因此可仅使得第一中层扩张管 322膨胀至扩张状态， 而使第一 外层扩张管 321处于折叠状态。
[0093] 之后， 可回抽中层管腔 350中的液体， 从而使中层管腔 350以及第一外层管腔 34 0的管壁恢复至初始状态， 即使第一中层扩张管 322恢复到折叠状态。
[0094] 以下说明通过支架输送装置将支架 100植入到病灶处的过程。 图 11为本发明实 施例一中支架 100从鞘管 210中释放后的一种结构示意图， 图 12为本发明实施例 一中支架 100在心脏中从鞘管 210中释放后的一种结构示意图， 图 13为本发明实 施例一中支架 100从鞘管 210中释放后的另一种结构示意图， 图 14为本发明实施 例一中支架 100在心脏中从鞘管 210中释放后的另一种结构示意图。 参考图 11至 图 14， 通过支架输送装置将支架 100植入到病灶处的过程包括：
[0095] 首先， 支架输送装置的远端 （连接头 310和鞘管 210的远端等） 从穿刺口进入人 体， 顺着股静脉或者动脉 （主动脉瓣置换走股动脉通路， 二尖瓣、 三尖瓣置换 走股静脉通路） 的血管通路， 将支架输送装置的远端输送至病变的瓣环处， 这 种情况下， 支架 100被压握在鞘管 210中， 第一中层扩张管 322和第一外层扩张管 321均处于折叠状态。
[0096] 其次， 支架输送装置的远端到达指定的病变的瓣环处， 调整支架输送装置的远 端的位置和角度后， 通过驱动手柄 400使外管组件 200整体向近端移动， 开始释 放支架 100直至支架 100完全释放到指定位置并脱离支架输送装置。 具体地， 鞘 管 210在向靠近鞘管 210的近端移动的过程中， 支架 100的流入道先被释放， 随着 鞘管 210的不断移动， 支架 100的流出道慢慢被释放， 直至鞘管 210的远端移动至 固定件 370处露出固定件 370的凹槽， 以使支架 100被完全从鞘管 210中释放。 这 种情况下， 支架 100从鞘管 210中释放， 且第一中层扩张管 322和第一外层扩张管 321均处于折叠状态。 支架 100从鞘管 210中释放后的示意图可参考图 11和图 12。
[0097] 然后， 向内导管 300中注入介质以使第一外层扩张管 321膨胀至扩张状态， 以调 整释放后的支架 100 （所述支架处于扩张状态） 的形态。 具体的， 通过介质输送 装置经由第一外层阀门 510向第一外层管腔 340中注入介质 （液体或者气体， 所 述液体可为具有显影功能的液体） ， 并使介质的压力维持在第二压力状态， 以 使第一外层扩张管 321在介质的作用下膨胀至扩张状态， 以使第一外层扩张管 32 1的管壁贴合释放后的支架 100的内壁， 通过第一外层扩张管 321的管壁给支架 10 0提供径向支撑力， 辅助支架 100恢复形态 （当支架 100为记忆合金支架 100可使 支架 100恢复记忆形态） ， 从而使支架 100释放后周向能更均匀地分布， 更好地 发挥支架 100的功能。 这种情况下， 支架 100从鞘管 210中释放， 且第一外层扩张 管 321处于扩张状态。 第一外层扩张管 321扩张后的示意图可参考图 13和图 14。
[0098] 之后， 可回抽第一外层管腔 340中的液体， 从而使第一外层管腔 340的管壁恢复 至初始状态， 这种情况下， 第一外层扩张管 321和第一中层扩张管 322恢复到折 叠状态。
[0099] 最后， 撤出支架输送装置。 具体的， 先驱动鞘管 210向远端移动， 使得连接头 3 10和鞘管 210平滑地连接在一起。 然后， 通过手柄 400使得外管组件 200、 支撑导 管 320和连接导管 330等退出人体。
[0100] 本实施例中的支架输送装置在装载支架 100和释放支架 100的过程中， 还可以既 通过介质输送装置经由第一外层阀门 510向第一外层管腔 340中注入介质， 又可 以通过介质输送装置经由中层阀门 520向中层管腔 350中注入介质， 以使第一外 层管腔 340和中层管腔 350膨胀。
[0101] 本实施例还提供一种实施例一中的支架输送装置中装载支架 100的支架装载方 法。 所述支架装载方法包括：
[0102] 首先， 将支架 100通过鞘管 210压握在内导管 300的外表面上。
[0103] 其次， 向内导管 300中注入介质， 以使内导管 300膨胀至扩张状态， 以调整压握 在鞘管 210的管腔内的支架 100的形态。
[0104] 向内导管 300中注入介质， 以使内导管 300膨胀至扩张状态， 以调整压握在鞘管 210的管腔内的支架 100的形态具体是： 通过介质输送装置经由中层阀门 520向中 层管腔 350中注入介质， 以使第一中层扩张管 322在介质的作用下膨胀至扩张状 态， 从而通过第一中层扩张管 322使第一外层扩张管 321膨胀， 以使第一外层扩 张管 321的管壁贴合压握在鞘管 210的管腔内的支架 100的内壁， 并在注入的介质 的作用下调整压握在鞘管 210的管腔内的支架 100的形态。
[0105] 本实施例中的支架输送装置， 由于鞘管 210套设在所述支撑导管 320的外表面上 ， 并且支撑导管 320用于膨胀压握在鞘管 210的管腔内的支架 100, 并且所述第一 中层扩张管 322的外表面在扩张状态下的外径小于鞘管 210的内径。 因此， 当鞘 管 210将支架 100压握在支撑导管 320上后， 可通过支撑导管 320扩张支架 100， 即 通过使第一中层扩张管 322膨胀至扩张状态以使第一外层扩张管 321膨胀， 并使 第一外层扩张管 321的管壁贴合压握在鞘管 210的管腔内的支架 100的内壁， 通过 中层管腔 350中的液体的挤压， 可调整压握在鞘管 210的管腔内的支架 100的形态 ， 从而可减小压握在所述鞘管 210的管腔内的支架 100应力不平均的现象， 改善 支架 100的周向均匀性， 减小支架 100向内凹陷的现象， 即可改善支架 100装载均 匀性， 进而减小支架 100由于出现上述现象导致支架 100在释放过程中出现扭曲 、 内陷， 从而影响释放质量， 损伤周边组织， 影响瓣膜疲劳， 甚至损坏输送系 统， 影响回撤功能的风险， 即可改善支架 100释放成功率。
[0106] 本实施例中的支架输送装置， 由于鞘管 210套设在所述支撑导管 320的外表面上 ， 支撑导管 320用于扩张压握在鞘管 210的管腔内的支架 100, 并且所述第一外层 扩张管 321的外表面在扩张状态下的外径大于鞘管 210的外径。 因此， 当支架 100 从鞘管 210中释放后， 可通过使第一外层扩张管 321膨胀至扩张状态， 并使第一 外层扩张管 321的管壁贴合从鞘管 210中释放后的支架 100的内壁， 通过第一外层 管腔 340中的液体的挤压， 可调整释放后的支架 100的形态， 从而使支架 100释放 后在周向能更均匀地分布， 以改善支架 100的释放质量， 更好地发挥支架 100的 功能。 相比于现有技术中的支架输送装置， 本实施例中的支架输送装置在支架 1 00从鞘管 210中释放之后， 可根据即刻的手术结果来判断是否需要调整支架 100 的形态， 即是否需要膨胀第一外层扩张管 321至扩张状态进而调整支架 100的形 态， 若出现如严重的钙化难以靠支架 100自膨撑开， 或解剖结构复杂的条件下支 架 100未撑开到理想程度等情况， 需要调整支架 100的形态， 则可直接通过膨胀 第一外层扩张管 321至扩张状态进而调整支架 100的形态， 无需将支架输送装置 从人体中撤出， 再将球囊套件输送至人体中以调整支架 100的形态， 可以节省操 作时间且简化操作步骤， 降低操作时间过长、 操作步骤繁琐使病人的生命体征 不稳定以致发生意外的风险。
[0107] 需要说明的是， 实施例一中第一外层扩张管 321和第一中层扩张管 322处于折叠 状态时， 均可以理解为第一外层扩张管 321和第一中层扩张管 322处于初始状态 ， 即在该初始状态下， 所述第一外层扩张管 321和第一中层扩张管 322的外表面 均折叠， 第一外层管腔 340和中层管腔 350中均未填充介质， 或者部分填充有介 质， 但填充的介质不足以使得第一外层扩张管 321的外表面与支架 100的内壁相 贴合， 并且所述第一外层扩张管 321的外表面在扩张状态下的外径大于在初始状 态下的外径， 所述第一中层扩张管 322的外表面在扩张状态下的外径大于在初始 状态下的外径。 [0108]
[0109] 实施例二
[0110] 本实施例提供一种与实施例一中的支架输送装置不同的支架输送装置。 参考图 15至图 17 , 图 15是本发明实施例二中的支架输送装置在收缩状态下的剖面示意 图， 图 16是图 15中的支架输送装置沿 B-B线的剖面示意图， 图 17是本发明实施例 二中的支架输送装置在第一扩张状态下的剖面示意图， 本实施例中的支架输送 装置与实施例一中支架输送装置的区别主要在于， 本实施例中， 所述支架输送 装置中的支撑导管 710和连接导管 720不同于实施例一中的支架输送装置中的支 撑导管 320和连接导管 330。
[0111] 参考图 15至图 17， 所述支架输送装置包括手柄 800、 外管组件 600、 内导管 700
、 介质输送装置、 第二外层_门810和第二内层_门820。 其中， 所述内导管 700 包括从远端到近端依次连接的连接头 730、 支撑导管 710、 连接导管 720和固定件
740。
[0112] 所述外管组件 600包括鞘管 610和外管 620, 所述鞘管 610与所述外管 620固定连 接， 所述外管 620与手柄 800连接。 所述鞘管 610用于压握并容置支架 100。 所述 外管 620具体可与手柄 800中的活动部件连接， 从而可通过驱动手柄 800中的活动 部件移动， 进而可通过手柄 800中的活动部件驱动外管组件 600在所述支撑导管 7 10和所述连接导管 720的外表面上沿着支撑导管 710和所述连接导管 720的轴向移 动。
[0113] 所述支撑导管 710和所述连接导管 720可容置在所述外管组件 600的管腔内。 所 述支撑导管 710的远端与连接头 730连接， 所述支撑导管 710的近端与所述连接导 管 720的远端连接， 所述支撑导管 710用于扩张压握在所述鞘管 610的管腔内的支 架， 所述连接导管 720的近端与所述手柄 800固定连接。
[0114] 所述支撑导管 710包括第二外层扩张管 711和第二内层扩张管 712。 所述第二外 层扩张管 711套设在所述第二内层扩张管 712的外表面上。 所述第二外层扩张管 7 11和第二内层扩张管 712的远端与所述连接头 730固定连接， 所述第二外层扩张 管 711和第二内层扩张管 712的近端与所述连接导管 720的远端固定连接。
[0115] 所述第二外层扩张管 711具有收缩状态、 第一扩张状态和第二扩张状态。 所述 第二外层扩张管 711的外表面在收缩状态下未完全张开或者折叠在一起， 在第一 扩张状态和第二扩张状态下膨胀呈球囊状。 所述第二内层扩张管 712的外径和结 构不会随着不同的工作状态发生变化。 其中， 所述第二外层扩张管 711的外表面 在第二扩张状态下的外径大于所述鞘管 610的外径， 并且所述第二外层扩张管 71 1的外表面在第一扩张状态下的外径小于鞘管 610的内径。 所述第二外层扩张管 7 11的外表面在第一扩张状态下的外径的取值范围在 4mm到 13mm之间， 所述第二 外层扩张管 711的外表面在第二扩张状态下的外径的取值范围在 16mm到 40mm之 间。
[0116] 所述连接导管 720包括第二外层连接导管 721和第二内层连接导管 722。
[0117] 所述第二外层连接导管 721套设所述第二内层连接导管 722的外表面上。 所述第 二外层连接导管 721与所述第二外层扩张管 711连接， 第二内层连接导管 722与所 述第二内层扩张管 712连接。 所述第二外层连接导管 721、 第二内层连接导管 722 与所述手柄 800固定连接。 其中， 所述第二外层连接导管 721和所述第二外层扩 张管 711与所述第二内层连接导管 722与所述第二内层扩张管 712围成第二外层管 腔 750; 所述第二内层连接导管 722和所述第二内层扩张管 712的内腔为第二内层 管腔 760。
[0118] 其中， 本实施例中， 所述第二外层连接导管 721和第二内层连接导管 722和第二 内层扩张管 712的外径和结构不会随着不同的工作状态发生变化。
[0119] 所述第二外层连接导管 721和第二内层连接导管 722的材料可为高分子材料、 高 分子 /金属复合材料中的一种。
[0120] 具体的， 所述第二外层连接导管 721和第二内层连接导管 722与所述手柄 800中 的固定部件连接， 以限制支撑导管 710和连接导管 720的六个自由度。 即使所述 支撑导管 710和连接导管 720相对所述手柄 800固定， 从而降低装载到输送装置上 的支架移位的风险。
[0121] 第二内层扩张管 712与第二内层连接导管 722可以采用一根材质均匀分布的管材 织造而成， 也可以采用两根管材分开制造后固定连接而成， 其中， 两根管材的 直径可相同。 第二外层扩张管 711与第二外层连接导管 721由不同的材料制备， 然后固定连接而成。 使用不同的材料的目的在于， 使得第二外层扩张管 711在收 缩状态下可以被折叠或者处于未完全张开的状态， 在第一扩张状态和第二扩张 状态下可以膨胀呈球囊状。
[0122] 所述介质输送装置用于分别向所述第二外层管腔 750和第二内层管腔 760中注入 液体， 以及分别抽出所述第二外层管腔 750和第二内层管腔 760中的液体。 所述 第二内层管腔 760中可设置导丝。
[0123] 所述第二外层阀门 810和第二内层阀门 820分别设置在第二外层管腔 750与介质 输送装置和第二内层管腔 760与介质输送装置之间。
[0124] 本实施例中， 所述第二外层扩张管 711为弹性体， 所述第二外层扩张管 711采用 高弹性材料， 例如， 热塑性弹性体 （TPE） ， 使得所述第二外层扩张管 711可以 实现第一扩张状态和第二扩张状态。 本实施例中将支架装载到支架输送装置的 过程中， 向内导管 700中注入介质以使内导管 700膨胀至第一扩张状态以调整压 握在鞘管 610的管腔内的支架的形态的步骤不同于实施例一。 具体的， 本实施例 中向内导管 700中注入介质以使内导管 700扩张至扩张状态以调整压握在鞘管 610 的管腔内的支架的形态具体包括：
[0125] 通过介质输送装置经由第二外层阀门 810向第二外层管腔 750中注入介质 （液体 或者气体） ， 并使介质的压力维持在第一压力状态， 以使第二外层管腔 750在介 质的作用下膨胀至第一扩张状态， 从而使第二外层扩张管 711的管壁贴合压握在 鞘管 610的管腔内的支架的内壁， 以调整压握在鞘管 610的管腔内的支架的形态 。 在第二外层扩张管 711膨胀的过程中， 由于第二外层扩张管 711的外表面在第 一扩张状态下的外径小于鞘管 610的内径， 因此可使第二外层扩张管 711膨胀至 第一扩张状态， 而不至膨胀至第二扩张状态。
[0126] 本实施例中通过支架输送装置将支架植入到病灶处的过程中， 向内导管 700中 注入介质以使第二外层扩张管 711膨胀至第二扩张状态以调整释放后的支架的形 态不同于实施例一。 本实施例中， 向内导管 700中注入介质以使第二外层扩张管 711膨胀至第二扩张状态以调整释放后的支架的形态的步骤具体包括：
[0127] 通过介质输送装置经由第二外层阀门 810向第二外层管腔 750中注入介质 （液体 或者气体， 所述液体可为具有显影功能的液体） ， 并使介质的压力维持在第二 压力状态， 以使第二外层扩张管 711在介质的作用下扩张至第二扩张状态， 以使 第二外层扩张管 711的管壁贴合释放后的支架的内壁， 以调整释放后的支架的形 态。 其中， 通过第二外层扩张管 711的管壁给支架提供径向支撑力， 辅助支架恢 复形态 （当支架为记忆合金支架可使支架恢复记忆形态） ， 从而使支架释放后 周向能更均匀地分布， 更好得发挥支架的功能。
[0128] 本实施例还提供一种实施例二中的支架输送装置中装载支架的支架装载方法。
所述支架装载方法包括：
[0129] 首先， 将通过鞘管 610压握在内导管 700的外表面上的支架从鞘管 610中释放出 来。
[0130] 其次， 向内导管 700中注入介质， 以使内导管 700膨胀至第二扩张状态， 以调整 释放后的支架的形态。
[0131] 向内导管 700中注入介质， 以使内导管 700膨胀至第二扩张状态， 以调整释放后 的支架的形态具体是： 通过介质输送装置经由第二外层阀门 810向第二外层管腔 750中注入介质， 以使第二外层扩张管 711在介质的作用下膨胀至第二扩张状态 ， 以使第二外层扩张管 711的管壁贴合释放后的支架的形态， 并在注入的介质的 作用下调整释放后的支架的内腔形态。
[0132] 本实施例中的支架输送装置， 由于鞘管 610套设在所述支撑导管 710的外表面上 ， 并且支撑导管 710用于膨胀压握在鞘管 610的管腔内的支架， 并且所述第二外 层扩张管 711的外表面在第一扩张状态的外径小于鞘管 610的内径。 因此， 当鞘 管 610将支架压握在支撑导管 710上后， 可通过使第二外层扩张管 711膨胀， 并使 第二外层扩张管 711的管壁贴合压握在鞘管 610的管腔内的支架的内壁， 以使内 导管 700处于第一扩张状态， 在第二外层管腔 750中的液体的挤压下， 可调整压 握在鞘管 610的管腔内的支架的形态， 从而可减小压握在所述鞘管 610的管腔内 的支架应力不平均的现象， 改善支架的周向均匀性， 减小支架向内凹陷的现象 ， 即可改善支架装载均匀性， 进而减小支架由于出现上述现象导致支架在释放 过程中出现扭曲、 内陷， 从而影响释放质量， 损伤周边组织， 影响瓣膜疲劳， 甚至损坏输送系统， 影响回撤功能的风险， 即可改善支架释放成功率。
[0133] 本实施例中的支架输送装置， 由于鞘管 610套设在所述支撑导管 710的外表面上 ， 支撑导管 710用于扩张压握在鞘管 610的管腔内的支架， 并且所述第二外层扩 张管 711的外表面在第二扩张状态下的外径大于鞘管 610的外径。 因此， 当支架 从鞘管 610中释放后， 可通过使第二外层扩张管 711膨胀至第二扩张状态， 并使 第二外层扩张管 711的管壁贴合从鞘管 610中释放后的支架的内壁， 在第二外层 管腔 750中的液体的挤压下， 可调整释放后的支架的形态， 从而使支架释放后在 周向能更均匀地分布， 以改善支架的释放质量， 更好地发挥支架的功能。 相比 于现有技术中的支架输送装置， 本实施例中的支架输送装置在支架从鞘管 610中 释放之后， 可根据即刻的手术结果来判断是否需要调整支架的形态， 即是否需 要膨胀第一外层扩张管至扩张状态进而调整支架的形态， 若出现如严重的钙化 难以靠支架自膨撑开， 或解剖结构复杂的条件下支架未撑开到理想程度等情况 ， 需要调整支架的形态， 则可直接通过膨胀第一外层扩张管至扩张状态进而调 整支架的形态， 无需将支架输送装置从人体中撤出， 再将球囊套件输送至人体 中以调整支架的形态， 可以节省操作时间且简化操作步骤， 降低操作时间过长 、 操作步骤繁琐使病人的生命体征不稳定以致发生意外的风险。
[0134] 需要说明的是， 实施例二中第二外层扩张管 711处于收缩状态时， 可以理解为 第二外层扩张管 711处于初始状态， 即在该初始状态下， 所述第二外层扩张管 71 1的外表面折叠或者处于未张开的状态， 第二外层管腔 750均未填充介质， 或者 部分填充有介质， 但填充的介质不足以使得第二外层扩张管 711的外表面与支架 的内壁相贴合， 并且所述第第二外层扩张管 711的外表面在第一扩张状态下的外 径大于在初始状态下的外径。
[0135]
[0136] 上述实施例中的“近端”和“远端”是从使用该医疗器械的医生角度来看相对于彼 此的元件或动作的相对方位、 相对位置、 方向， 尽管“近端”和“远端”并非是限制 性的， 但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端， 而“远 端”通常是指首先进入患者体内的一端。 此外， 上述实施例中的术语“或”通常是 以包括“和 /或”的含义而进行使用的， 另外明确指出的除外。 上述实施例中， “两 端”是指近端和远端。
[0137] 上述描述仅是对本发明较佳实施例的描述， 并非对本发明范围的任何限定， 本发明领域的普通技术人员根据上述揭示内容做的任何变更、 修饰， 均属于权 利要求书的保护范围。

Claims

权利要求书
[权利要求 1] 一种支架输送装置， 其用于输送支架， 包括鞘管和内导管， 其特征在 于， 所述鞘管套设在所述内导管外， 所述内导管具有第一扩张状态， 在所述第一扩张状态下， 所述支架可压握在所述鞘管内， 所述内导管 呈球囊状， 所述内导管的外表面贴合压握状态下的所述支架的内壁， 且所述内导管的外径小于所述鞘管的内径。
[权利要求 2] 如权利要求 1所述的支架输送装置， 其特征在于， 所述内导管包括外 层扩张管和外层连接导管， 所述外层连接导管的远端与所述外层扩张 管连接， 所述支架套设在所述外层扩张管的外表面上， 在所述第一扩 张状态下， 所述外层扩张管呈球囊状。
[权利要求 3] 如权利要求 2所述的支架输送装置， 其特征在于， 所述内导管还具有 第二扩张状态；
在所述第二扩张状态下， 所述外层扩张管呈球囊状， 所述支架位于所 述鞘管外且处于扩张状态， 所述外层扩张管的外表面贴合所述支架的 内壁， 所述外层扩张管的外径大于所述鞘管的外径。
[权利要求 4] 如权利要求 1所述的支架输送装置， 其特征在于， 所述内导管还具有 一初始状态， 所述内导管在所述初始状态下的外径小于在所述第一扩 张状态下的外径。
[权利要求 5] 如权利要求 2所述的支架输送装置， 其特征在于， 所述内导管还包括 内层扩张管、 内层连接导管、 连接头和固定件， 所述支架输送装置还 包括手柄， 所述外层扩张管套设在所述内层扩张管的外表面上， 所述 外层连接导管套设在所述内层连接导管的外表面上， 所述内层连接导 管的远端与所述内层扩张管连接， 所述外层扩张管的远端和所述内层 扩张管的远端与所述连接头固定连接， 所述外层连接导管的近端和所 述内层连接导管的近端与所述手柄固定连接， 所述固定件固定设置在 所述外层扩张管和 /或外层连接导管的外表面上， 所述固定件用于固 定所述支架， 所述手柄用于驱动所述鞘管在所述内导管的外表面上沿 着所述内导管的轴向移动。
[权利要求 6] 如权利要求 5所述的支架输送装置， 其特征在于， 所述外层扩张管和 所述外层连接导管与所述内层扩张管和所述内层连接导管围成第一外 层管腔， 所述内导管还包括第一外层阀门和介质输送装置， 所述第一 外层阀门设置在所述第一外层管腔与所述介质输送装置之间， 所述介 质输送装置用于经过所述第一外层阀门向所述第一外层管腔中注入介 质。
[权利要求 7] 如权利要求 1所述的支架输送装置， 其特征在于， 所述内导管包括外 层扩张管、 外层连接导管、 中层扩张管和中层连接导管， 所述外层连 接导管的远端与所述外层扩张管连接， 所述中层连接导管的远端与所 述中层扩张管连接， 所述外层扩张管和外层连接导管分别套设在所述 中层扩张管和所述中层连接导管的外表面上， 所述支架套设在所述外 层扩张管的外表面上， 在所述第一扩张状态下， 所述中层扩张管呈球 囊状， 所述外层扩张管呈折叠状。
[权利要求 8] 如权利要求 7所述的支架输送装置， 其特征在于， 所述内导管还具有 第二扩张状态， 在所述第二扩张状态下， 所述外层扩张管呈球囊状， 所述支架位于所述鞘管外且处于扩张状态， 所述外层扩张管的外表面 贴合所述支架的内壁， 所述外层扩张管在所述第二扩张状态下的外径 大于所述鞘管的外径。
[权利要求 9] 如权利要求 7所述的支架输送装置， 其特征在于， 所述内导管还具有 一初始状态， 在所述初始状态下， 所述外层扩张管和所述中层扩张管 呈折叠状， 所述中层扩张管在所述第一扩张状态下的外径大于所述外 层扩张管在所述初始状态下的外径。
[权利要求 10] 如权利要求 7所述的支架输送装置， 其特征在于， 所述内导管还包括 内层扩张管、 内层连接导管、 连接头和固定件， 所述支架输送装置还 包括手柄， 所述中层扩张管套设在所述内层扩张管的外表面上， 所述 中层连接导管套设在所述内层连接导管的外表面上， 所述内层连接导 管的远端与所述内层扩张管连接， 所述外层扩张管、 所述中层扩张管 和所述内层扩张管的远端与所述连接头固定连接， 所述外层连接导管 、 所述中层连接导管和所述内层连接导管的近端与所述手柄固定连接 ， 所述固定件固定设置在所述外层扩张管和 /或所述外层连接导管的 外表面上， 所述固定件用于固定所述支架， 所述手柄用于驱动所述鞘 管在所述内导管的外表面上沿着所述内导管的轴向移动。
[权利要求 11] 如权利要求 10所述的支架输送装置， 其特征在于， 所述外层扩张管和 所述外层连接导管与所述中层扩张管和所述中层连接导管围成第二外 层管腔， 所述中层扩张管和所述中层连接导管与所述内层扩张管和所 述内层连接导管围成中层管腔， 所述内导管还包括第二外层阀门、 中 层阀门和介质输送装置， 所述第二外层阀门设置在所述第二外层管腔 与所述介质输送装置之间， 所述中层阀门设置在所述中层管腔与所述 介质输送装置之间， 所述介质输送装置用于经过所述中层阀门向所述 中层管腔中注入介质， 以及经过所述第二外层阀门向所述第二外层管 腔中注入介质。
[权利要求 12] 一种如权利要求 1至 11任一项所述的支架输送装置的支架装载方法， 其特征在于， 包括：
将套设在所述内导管的外表面上的所述支架压握在所述鞘管的管腔内 向所述内导管的管腔内注入介质， 并使所述内导管膨胀至所述第一扩 张状态， 以使所述内导管呈球囊状， 并使所述内导管的外表面贴合压 握状态下的所述支架的内壁。
[权利要求 13] 如权利要求 12所述的支架输送装置的支架装载方法， 其特征在于， 还 包括释放所述内导管的管腔内的介质， 以使所述内导管处于初始状态
PCT/CN2019/126696 2018-12-29 2019-12-19 支架输送装置和支架装载方法 WO2020135229A1 (zh)

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