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WO2018121344A1 - 管腔支架及其输送系统 - Google Patents

管腔支架及其输送系统 Download PDF

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Publication number
WO2018121344A1
WO2018121344A1 PCT/CN2017/117158 CN2017117158W WO2018121344A1 WO 2018121344 A1 WO2018121344 A1 WO 2018121344A1 CN 2017117158 W CN2017117158 W CN 2017117158W WO 2018121344 A1 WO2018121344 A1 WO 2018121344A1
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WO
WIPO (PCT)
Prior art keywords
stent
lumen
proximal
delivery system
proximal end
Prior art date
Application number
PCT/CN2017/117158
Other languages
English (en)
French (fr)
Inventor
王刚
关成梅
Original Assignee
先健科技(深圳)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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2018121344A1 publication Critical patent/WO2018121344A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • 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 field of cardiovascular medical devices, in particular to a lumen support and a delivery system thereof.
  • the stent is continuously improved to improve the adaptability of the stent to human blood vessels, such as flexibility and adherence, and on the other hand, the improvement of the delivery system to improve the precise controllable delivery, positioning and release of the stent.
  • U.S. Patent No. 7,246,632 B2 discloses a proximally controllable release stent delivery system employing a TIP head with a cap that defines a portion of the proximal bare stent therein and is constrained by a distal assembly Axial movement of the bracket.
  • the stent system release process generally removes the outer sheath tube successively, completes the partial release of the main body bracket, and then opens the locking mechanism of the proximal bare bracket through the control mechanism (for example, moving the cap forward, the stent is disengaged therefrom) freed).
  • This release solves the problem of inaccurate positioning of the proximal bare stent, but it cannot guarantee the accurate positioning of the stent at the beginning of the stent, especially for the stent with the multi-circle bare stent, if the proximal bare stent is fixed by the locking mechanism, the release is released.
  • the bare stent will be stretched, and the bare stent will be deformed and stretched, causing the proximal end of the stent graft to move toward the proximal end (hand side), thereby causing the positioning of the stent graft to fail, and even leading to failure of interventional surgery. The risk of surgery for the patient.
  • the technical problem to be solved by the present invention is that, in view of the defects of the prior art, a lumen stent with a proximal end of the stent graft is accurately positioned, and a bare stent portion is not easily deformed during the release process, and a delivery system thereof.
  • the technical solution adopted by the present invention to solve the technical problem thereof is to provide a lumen stent comprising a stent graft and a bare stent connected to the proximal end of the stent graft, the lumen stent further comprising an axially inextensible
  • a long positioning device is fixed to the proximal end of the stent graft.
  • the positioning device includes a fixed end disposed at a proximal end of the stent graft, a connecting segment extending from the fixed end, and a positioning end disposed at an end of the connecting segment.
  • the positioning device is an elongated rope-like structure, and the positioning end is an annular member disposed at an end of the rope structure.
  • the bare stent includes an extension connected to the stent graft and a corrugated ring connected to the extension, the string structure being at least partially fixed to the extension on.
  • the extension section includes a plurality of wavelet loops arranged in the axial direction, and the connecting sections are at least partially alternately disposed between the plurality of the wavelet loops.
  • the extension section is a woven mesh tubular structure
  • the connecting section is at least partially alternately disposed in the mesh tubular structure.
  • the wave crest is further provided with barbs on the peaks.
  • the positioning device is a closed positioning ring that is fixed to the proximal end of the stent graft.
  • the closed positioning ring includes a fixed point disposed on a proximal end of the stent graft and a closed loop extending from the fixed end.
  • the positioning device is made of plastic rope or wire.
  • the positioning device is supported by a plastic cord, which is a polypropylene suture or a PTFE suture.
  • a delivery system for delivering a lumen stent as described above, comprising an outer sheath tube for receiving the lumen stent for pushing out a push rod of the lumen support, an outer core tube connected to the push rod, an anchoring member connected to the outer core tube, passing through the anchoring member and the outer core tube, and relative to the An inner core tube axially sliding of the outer core tube and a fixed cap and a tip sleeve sleeved outside the inner core tube and axially slidable relative to the inner core tube.
  • the anchoring member comprises a tapered body connected to the distal end of the push rod and a cylindrical body extending from a larger end of the tapered body, the tapered body being circumferentially distributed with a limiting piece,
  • the columnar body is circumferentially spaced apart and has a receiving groove, and a partition is formed between any two adjacent receiving grooves, the column body is inserted into the fixing cap, the receiving groove and the fixing cap
  • the inner side wall defines an enclosed space for locking the proximal end of the lumen stent.
  • the outer core tube includes an outer sleeve and an inner sleeve
  • the anchoring member includes a proximal anchor and a distal anchor, the proximal end of the outer sleeve being connected to the distal end of the push rod
  • the distal end of the outer cannula is coupled to the proximal fixation anchor
  • the inner cannula passes through the proximal fixation anchor and the outer cannula and is axially slidable relative to both, the inner cannula being distal The end is connected to the distal anchor.
  • the proximal fixation anchor includes a body coupled to the distal end of the outer cannula and a body disposed circumferentially along the body.
  • the distal fixation anchor comprises a cone connected to the distal end of the inner cannula and a column extending from a larger end of the cone, the circumferential distribution of the cone being limited
  • the columnar body is circumferentially spaced apart with a receiving groove, and a partition is formed between any two adjacent receiving grooves, and the column body is inserted into the fixing cap to form a locking ring for locking The enclosed space of the object.
  • the limiting member comprises a first limiting member and a second limiting member staggered along the circumferential direction of the tapered body, wherein the first limiting member is used for hooking the corrugated ring And a portion of the distal end of the first limiting member located in the accommodating groove is provided with a step portion, and the step portion and the partition portion have a circumferential surface And abutting against the fixing cap; the distal end of the second limiting member abuts the proximal end of the partition portion and its height in the radial direction is greater than the height of the partition portion in the same direction to form A stop that limits the movement of the fixed cap toward the proximal end.
  • the present invention provides a frictional force (the main source of the stent release resistance) of the stent graft and the inner wall of the sheath tube by the positioning device provided on the stent. Passed to the delivery system, rather than directly through the bare stent, to ensure accurate positioning of the initial end of the stent graft, can avoid the looseness of the bare stent waveform during the stent release process with the multi-circle bare stent structure Damage caused by excessive traction of the stent.
  • FIG. 1 is a schematic structural view of a first embodiment of a lumen stent according to the present invention
  • FIG. 2 is a schematic view showing the connection between the positioning device and the bare bracket in the first embodiment of the lumen stent of the present invention
  • FIG. 3 is a schematic structural view of a first embodiment of a conveying system of the present invention.
  • Figure 4 is a schematic view showing the structure of the anchoring member in the first embodiment of the conveying system of the present invention
  • Figure 5 is a schematic view showing the assembly of the lumen support in the released state shown in Figure 1 and the delivery system shown in Figure 3;
  • Figure 6 is a schematic view showing the assembly of the lumen stent shown in Figure 1 in the outer sheath tube of the delivery system shown in Figure 3;
  • Figure 7 is a schematic structural view of a second embodiment of a lumen stent according to the present invention.
  • Figure 8 is an enlarged view of a portion A of the second embodiment of the lumen stent of the present invention.
  • Figure 9 is a schematic structural view of a second embodiment of a conveying system of the present invention.
  • Figure 10 is a schematic view showing the assembly of the lumen stent shown in Figure 7 and the delivery system shown in Figure 9;
  • Figure 11 is an enlarged view of a portion B of Figure 10 of the present invention.
  • Figure 12 is an assembled view of the delivery system of Figure 9 with the lumen stent of Figure 7 in a fully released state.
  • a lumen stent 100 includes a stent graft 110 that is compressible and compressible in its radial direction and a bare stent 120 that is coupled to the stent graft 110.
  • the stent graft 110 includes a mesh-shaped stent body 111 and a coating 112 coated on the stent body 111.
  • the meshed stent body 111 includes a plurality of coils spaced along the axial spacing of the lumen stent 100.
  • the wave ring is shaped by nickel-titanium wire weaving, and the film 112 is stitched to the stent body 111 using a polyester material.
  • the bare stent 120 includes a mesh extension 121 connected to the beginning of the stent graft 110, a corrugated annulus 122 coupled to the extension 121, and a barb 123 secured to the crest of the corrugated annulus 122.
  • the web-shaped extension 121 includes a plurality of wavelet loops arranged axially spaced apart, and the corrugated loop 122 is a single-turn large coil.
  • the corrugated ring 122 can be shaped by nickel-titanium wire weaving.
  • the mesh extension may also be formed by integrally cutting a metal material or by wire weaving.
  • the distance between the peak and the peak of the corrugated ring 122, or between the trough and the trough, is greater than the distance between the wavelet ring peak and the peak in the bare stent 120, or between the trough and the trough.
  • the trough of the corrugated ring 122 is connected to the peak of the wavelet ring at the proximal end.
  • the extension 121 of the bare stent 120 can increase the adherence and anchoring force of the lumen stent 100.
  • the lumen support 100 also includes a positioning device 130 that is secured to the proximal end of the stent graft 110.
  • the positioning device 130 includes a fixed end 131 disposed at a proximal end of the stent graft 110, a connecting portion 132 extending from the fixed end 131, and a positioning end 133 disposed at an end of the connecting portion 132.
  • the positioning device 130 is a rope-like structure having a lower elongation in the axial direction and having flexibility.
  • the positioning device 130 can be a wire or a plastic cord.
  • the positioning device 130 can utilize a polypropylene suture or a PTFE suture.
  • the reason why the axially inextensible material is used is to ensure that the positioning device 130 can firmly grasp the proximal end of the stent graft 110 during the release process of the lumen stent 100 as the sheath sheath is withdrawn. So that it stays in a specific position.
  • the fixed end 131 of the positioning device 130 can be firmly coupled to the proximal end of the stent graft 110 by suturing, knotting or welding.
  • the connecting section 132 is interspersed between the small wave loops of the plurality of extensions 121.
  • the rope-shaped positioning device 130 is pressed against the bare stent. Between 130 and the vessel wall, thereby preventing the rope-like positioning device 130 from floating in the blood, reducing the risk of thrombosis.
  • the locating end 133 at the end of the connecting section 132 is an annular structure for operatively associated with the anchoring component of the delivery system.
  • the annular structure can be formed by stitching, knotting or welding. It can be understood that the positioning end 133 can also be a hook-like structure as long as it can form an active connection with the anchoring member. It will be appreciated that the positioning end 133 must be movably coupled to the anchoring member to facilitate timely disengagement of the positioning device 130 from the delivery system after the lumen stent 100 is fully released.
  • the present invention also provides a delivery system 200 including an outer sheath tube 201, a push rod 202 disposed in the outer sheath tube 201 and axially slidable relative to the outer sheath tube 201, and a push rod 202 distally connected outer core tube 203, anchoring member 204 connected to the distal end of outer core tube 203, inner core tube 205 passing through anchoring member 204 and outer core tube 203 and slidable in the axial direction, sleeve A fixed cap 206 and a tip 207 are disposed outside the inner core tube 2056 and are slidable in the axial direction.
  • the anchoring member 204 includes a tapered body 204A secured to the distal end of the outer core tube 203 and a cylindrical body 204B extending distally from the larger end of the tapered body 204A.
  • the circumference of the cone 204 is distributed with a plurality of limiting members, and the limiting member includes a first limiting member 2041 and a second limiting member 2042.
  • the columnar bodies 204B are evenly spaced apart from each other by a plurality of accommodating grooves 2044 and a partition portion 2045 formed by a portion between any two adjacent accommodating grooves 2044.
  • the distal end of the first limiting member 2041 has a step portion 2043 that partially extends into the receiving groove and has a circumferential surface coplanar with the partition portion 2045.
  • the distal end of the second limiting member 2042 abuts the proximal end of the partitioning portion 2045, and the height of the second limiting member 2042 in the radial direction is greater than the height of the partitioning portion 2045 in the same direction to form the stopping portion 2046.
  • the lumen stent 100 is compressed in the outer sheath tube 201 before being transported to the lesion portion of the human blood vessel, and the peak of the corrugated ring 122 of the bare stent 120 is hooked on the first limiting member 2041 step.
  • the distal end of the portion 2043 and the barb 123 disposed on the peak are housed in the receiving groove 2044.
  • the positioning end 133 of the positioning device 130 is also hooked on the distal end of the step portion 2043, and the fixing cap 206 slides proximally until the stopper portion 2046 formed by the second limiting member 2042 and the partition portion 2045, thereby interacting with the anchoring member.
  • the cylindrical body 204B of 204 forms an enclosed space for locking the proximal end of the bare stent 120.
  • the string-shaped positioning device 130 is in a straightened state and is inextensible, whereby the proximal end of the stent graft 110 connected to the fixed end 131 of the positioning device 130 cannot move.
  • the outer sheath tube 201 is withdrawn by the operation of the delivery system handle (not shown) in the direction indicated by the arrow D1 in the figure.
  • the friction between the outer sheath tube 201 and the lumen stent 100 is transmitted to the anchoring device 204 through the connecting portion 132 of the positioning device 130, thereby avoiding the passage of the bare stent 120 due to friction.
  • the wave pattern caused by the direct transmission of the wavelet circle is messy.
  • the present invention transfers the frictional force to the anchoring member 204 of the delivery system 200 by the positioning device 130, thereby avoiding the messy waveform of the bare stent caused by the outer sheath tube 201 during the retraction process.
  • the outer sheath tube 201 is retracted in the direction of D1 until the stent graft 110 is completely released. At this time, due to the pulling action of the positioning device 130, the proximal end of the stent graft 110 is always in the initial position, and due to the positioning device The 130 has a very low elongation in the axial direction, so that the positioning of the proximal end of the stent graft 110 is still accurate under the great friction generated during the withdrawal of the sheath tube 201.
  • the fixed cap 206 and the tip 207 are retracted in the direction of D2 in the figure under the operation of the delivery system handle until the bare stent 120 is completely released, at this time the entire lumen stent 100 and the inner wall of the blood vessel. Tightly fitting, the barbs 123 at the proximal end of the bare stent 120 penetrate into the vessel wall to increase the anchoring force with the vessel wall.
  • the outer core tube 203 can be moved proximally by operating a slider mechanism on the handle of the delivery system 200, such that the positioning end 133 of the positioning device 130 is a ring-shaped structure and The first stop 2041 of the anchoring member 204 is disengaged, whereby the entire lumen support 100 is disengaged from the delivery system 200.
  • the present invention ensures that the proximal end of the stent graft is always positioned accurately by the positioning device on the lumen stent, and is not due to the outer sheath tube.
  • the friction caused by the withdrawal causes the proximal end of the stent graft to fail to locate.
  • the positioning device can also transmit the friction generated by the lumen support (mainly the stent graft) and the inner wall of the outer sheath tube (the main source of the stent release resistance) to the anchoring component of the delivery system, rather than directly through the bare stent. It can avoid the damage caused by the disordered coring of the bare stent and the excessive pulling of the bare stent during the stent release process of the lumen stent with the multi-circle bare stent structure.
  • a lumen stent 300 includes a stent graft 310 that is compressible and compressible in its radial direction and a bare stent 320 that is coupled to the stent graft 310.
  • the stent graft 310 includes a mesh-shaped stent body 311 and a coating 312 coated on the stent body 311.
  • the meshed stent body 311 includes a plurality of coils spaced along the axial spacing of the lumen stent 100.
  • the wave ring is shaped by nickel-titanium wire braiding, and the film 312 is stitched to the stent body 311 using a polyester material.
  • the bare stent 320 includes a mesh extension 321 connected to the beginning of the stent graft 310, a corrugated annulus 322 connected to the extension 321 and a barb 323 attached to the crest of the corrugated annulus 322.
  • the web-shaped extension 321 includes a plurality of axially spaced wavelet loops, and the corrugated annulus 322 is a single-turn large coil.
  • the corrugated ring 122 can be shaped by nickel-titanium wire weaving.
  • the mesh extension may also be formed by integrally cutting a metal material or by wire weaving.
  • the distance between the crest and the crest of the corrugated ring 122, or between the trough and the trough, is greater than the distance between the crest peak and the crest, or between the trough and the trough.
  • the trough of the large circle is connected to the crest of the near-wavelet circle.
  • the mesh extension may also be formed by integrally cutting a metal material or by wire weaving.
  • the extension 321 of the bare stent 320 can increase the adherence and anchoring force of the lumen stent 300.
  • the lumen support 300 also includes a positioning device 330 that is secured to the proximal end of the stent graft 310.
  • the positioning device 330 is a closed positioning ring.
  • the positioning device 330 can be made of wire or plastic rope, preferably formed by stitching, knotting or welding with polypropylene suture or PTFE suture.
  • the positioning ring includes a fixed point 331 that is fixed to the proximal end of the stent graft 310 and a closed loop 332.
  • the ring 332 is movably coupled to the anchoring component of the delivery system. It can be understood that the ring body 332 can also be a hook-like structure as long as it can form an active connection with the anchoring member.
  • the positioning device 330 In a state where the bare stent 320 is deployed and fitted to the blood vessel wall, the positioning device 330 is pressed between the bare stent 330 and the blood vessel wall, thereby preventing the positioning device 330 from floating in the blood, reducing the risk of thrombus generation.
  • the delivery system 400 of the present embodiment includes an outer sheath tube 401, a push rod 402 disposed in the outer sheath tube 401 and axially slidable relative to the outer sheath tube 401, and connected to the distal end of the push rod 402.
  • the outer core tube 403 includes an outer sleeve 4031 and an inner sleeve 4032.
  • the anchoring component 404 includes a proximal fixation anchor 4041 and a distal fixation anchor 4042.
  • the proximal anchor 4042 is preferably a metal material, such as stainless steel, to provide sufficient strength and anchoring force.
  • the proximal end of the outer cannula 4031 is coupled to the distal end of the push rod 402, and the distal end of the outer cannula 4031 is coupled to a control slider (not labeled) on the handle of the delivery system 400.
  • the axial movement of the proximal anchor 4041 can be achieved by manipulating the outer sleeve 4031 to slide axially along the inner sleeve 4032.
  • the inner cannula 4032 passes through the proximal fixation anchor 4041 and the outer cannula 4031 and is axially slidable relative to both, and the distal fixation anchor 4042 is secured to the distal end of the inner cannula 4032.
  • the inner core tube 405 passes through the distal fixed anchor 4042 and the inner sleeve 4032 and is axially slidable relative to both.
  • the proximal anchor 4041 includes a body that is coupled to the distal end of the outer cannula 4031 and a body 4043 that is circumferentially distributed along the body. Preferably, at least two hooks 4043 are distributed along the circumference of the body.
  • the distal fixation anchor 4042 is identical in construction to the anchoring member 204 of the first embodiment, which also includes a tapered body secured to the distal end of the inner cannula 4032 and a cylindrical body extending proximally from the larger end of the tapered body. .
  • the circumferential direction of the cone is distributed with a plurality of limiting members, and the limiting member comprises a first limiting member and a second limiting member.
  • the cylindrical bodies are evenly spaced apart in the circumferential direction with a plurality of accommodating grooves and a partition formed by a portion between any adjacent two accommodating grooves.
  • the distal end of the first limiting member has a step extending partially into the receiving groove and having a circumferential surface coplanar with the partition.
  • the distal end of the second limiting member abuts the proximal end of the partition, and the height of the second limiting member in the radial direction is greater than the height of the partition in the same direction to form a stopping portion.
  • the lumen stent 300 is compressed in the outer sheath tube 401 before being transported to the lesion portion of the human blood vessel, and the peak of the corrugated ring 322 of the bare stent 320 is hooked on the step of the first stopper.
  • the distal end, and the barb 323 disposed on the peak is housed in the accommodating groove.
  • the ring body 332 of the positioning device 330 is hooked on the hook body 4043 of the proximal fixing anchor 4041, and the fixing cap 406 slides to the proximal end until the stopper formed by the second limiting member and the partition portion is fixed to the distal end.
  • the columnar body of the anchor 4042 forms an enclosed space for locking the proximal end of the bare stent 320.
  • the proximal end of the stent graft 310 is always limited to the position of the proximal anchor 4041.
  • the outer sheath tube 301 is withdrawn under the control of a delivery system handle (not shown), during the withdrawal of the outer sheath tube 301, due to the distal fixation anchor 4042 and The proximal fixation anchor 4041 is relatively stationary, the bare stent 320 is constrained between the distal fixation anchor 4042 and the proximal fixation anchor 4041, and the friction between the stent graft 310 and the outer sheath 401 is transmitted through the positioning device 430.
  • the anchor 4041 is fixed to the proximal end, and is not applied to the bare bracket 320. Therefore, the bare bracket 320 does not stretch and deform, and the wave shape caused by the direct transmission of the small wave circle of the bare bracket 120 due to frictional force is avoided. Messy.
  • the outer sheath tube 401 is retracted until the stent graft 310 is completely released. At this time, since the proximal end of the stent graft 310 is fixed to the proximal anchor 4041 by the positioning device 430, and the positioning device 430 is in the axial direction. It has a very low elongation, so that it can ensure that the proximal end of the stent graft 310 is always positioned accurately under the great friction generated during the withdrawal of the sheath tube 401.
  • the fixation cap 406 and the tip 407 are retracted under the operation of the delivery system until the bare stent 320 is completely released, at which time the entire lumen stent 300 is in close contact with the inner wall of the blood vessel, and the bare stent 320 is closely attached.
  • the proximal barb 323 penetrates into the vessel wall to increase the anchoring force with the vessel wall.
  • the outer sleeve 4031 can be moved proximally by operating a slider mechanism on the handle of the delivery system 400 such that the ring body 332 of the positioning device 330 and the proximal anchor 4041 Disengaged, the entire lumen stent 300 is now detached from the delivery system 400.
  • the present invention provides a friction device between the lumen stent (mainly the stent graft) and the inner wall of the outer sheath tube by providing a positioning device on the lumen stent.
  • the force (the main source of stent release resistance) is transmitted to the anchoring component of the delivery system, rather than directly through the bare stent, which avoids the messy waveform of the bare stent that occurs during the stent release process with the multi-circle bare stent structure. Damage caused by excessive pulling of the bare stent.
  • the positioning device can ensure the accurate positioning of the proximal end of the stent graft during the lumen stent release process.

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  • Engineering & Computer Science (AREA)
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Abstract

一种管腔支架(100)及其输送系统(200)。管腔支架(100)包括覆膜支架(110)和与覆膜支架(110)近端相连的裸支架(120)。该管腔支架(100)还包括在轴向不可伸长的定位装置(130)，定位装置(130)固定于覆膜支架(110)的近端起始端，并与输送系统(200)的锚定部件(204)活动连接，从而保证所述覆膜支架(110)近端起始端的位置不会因为该管腔支架(100)的释放而改变。

Description

管腔支架及其输送系统 技术领域
本发明涉及心血管医疗器械领域，尤其涉及一种管腔支架及其输送系统。
背景技术
近年来，人们对覆膜支架不断提出了新的要求。一方面支架在不断的改进，以提高支架对人体血管的适应性，如柔顺性、贴壁性等性能，另一方面是输送系统的改进，以提高支架输送、定位和释放的精确可控。
美国专利US7264632B2公布了一种近端可控释放的支架输送系统，该专利实施方案采用一个带有帽套的TIP头，将近端裸支架的部分限定在其内，且通过一个远端组件限制支架的轴向移动。这种方式的支架系统释放过程一般是先后撤外鞘管，完成主体支架的部分释放，再通过控制机构打开近端裸支架的锁定机构(如将帽套向前移，使支架从其内脱出释放)。这种释放解决了近端裸支架定位不准的问题，但无法保证支架覆膜起始端定位精确，特别是对于含有多圈裸支架的支架，其近端裸支架若被锁定机构固定，在释放过程中裸支架会受力拉伸，裸支架部分变形伸长，造成覆膜支架起始端向近端(手柄一侧)移动，从而使支架覆膜起始端定位失效，甚至导致介入手术失败，增加病患的手术风险。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种覆膜支架近端起始端定位准确，裸支架部分在释放过程中不易变形的管腔支架及其输送系统。
本发明解决其技术问题所采用的技术方案是：提供一种管腔支架，其包括覆膜支架和与所述覆膜支架近端相连的裸支架，该管腔支架还包括在轴向不可伸长的定位装置，所述定位装置固定于所述覆膜支架的近端起始端。
在本发明一实施例中，所述定位装置包括设于所述覆膜支架近端起始端的的固定端、自所述固定端延伸的连接段以及设于所述连接段末端的定位端。
在本发明一实施例中，所述定位装置为细长的绳状结构，所述定位端为设于所述绳状结构末端的环形部件。
在本发明一实施例中，所述裸支架包括与所述覆膜支架相连的延长段以及与所述延长段相连的波形环状物，所述绳状结构至少有部分固定在所述延长段上。
在本发明一实施例中，所述延长段包括若干沿轴向排布的小波圈，所述连接段至少有部分交替穿设于若干个所述小波圈之间。
在本发明一实施例中，所述延长段为编织的网管状结构，所述连接段至少有部分交替穿设于所述网管状结构中。
在本发明一实施例中，所述波形环状物的波峰上还设有倒刺。
在本发明一实施例中，所述定位装置为固定于所述覆膜支架近端起始端的闭合定位环。
在本发明一实施例中，所述闭合定位环包括设置在所述覆膜支架近端起始端上的固定点以及自固定端延伸的闭合环体。
在本发明一实施例中，所述定位装置由塑料绳或金属丝制成。
在本发明一实施例中，所述定位装置由塑料绳支撑，所述塑料绳为聚丙烯缝线或PTFE缝合线。
本发明解决其技术问题采用的另一技术方案为：构造一种用于输送如上述所述的管腔支架的输送系统，其包括用于收容所述管腔支架的外鞘管、用于推出所述管腔支架的推杆、与所述推杆相连的外芯管、与所述外芯管相连的锚定部件、穿过所述锚定部件和所述外芯管并可相对于所述外芯管轴向滑动的内芯管以及套设在所述内芯管外并可相对于所述内芯管轴向滑动的固定帽和端头。
优选地，所述锚定部件包括与所述推杆远端相连的锥状体和自所述锥状体的较大端延伸的柱状体，所述锥状体的周向分布有限位件，所述柱状体周向间隔分布有容置槽，任意相邻两个所述容置槽之间形成分隔部，所述柱状体插入所述固定帽内，所述容置槽与所述固定帽的内侧壁形成用于锁定所述管腔支架 近端的封闭空间。
优选地，所述外芯管包括与外套管和内套管，所述锚定部件包括近端固定锚和远端固定锚，所述外套管近端与所述推杆的远端相连，所述外套管的远端与所述近端固定锚相连，所述内套管穿过所述近端固定锚和所述外套管并可相对于两者轴向滑动，所述内套管的远端与所述远端固定锚相连。
优选地，所述近端固定锚包括与所述外套管远端相连的主体和沿所述主体周向分布的勾体。
优选地，所述远端固定锚包括与所述内套管远端相连的锥状体和自所述锥状体的较大端延伸的柱状体，所述锥状体的周向分布有限位件，所述柱状体周向间隔分布有容置槽，任意相邻两个所述容置槽之间形成分隔部，所述柱状体插入所述固定帽内从而形成用于锁定所述波形环状物的封闭空间。
优选地，所述限位件包括沿所述锥状体周向交错分布的第一限位件和第二限位件，所述第一限位件用于勾挂所述波形环状物的波峰且其远端有部分位于所述容置槽内，所述第一限位件远端位于所述容置槽内的部分设有台阶部，所述台阶部与所述分隔部共圆周面并与所述固定帽抵接；所述第二限位件的远端与所述分隔部的近端抵接且其在径向上的高度大于所述分隔部在同方向上的高度从而形成用于限制所述固定帽向近端移动的止挡部。
本发明与现有的具有近端后释放功能的支架系统相比，本发明中通过在支架上设置的定位装置，使覆膜支架与鞘管内壁产生的摩擦力(支架释放阻力的主要来源)传递到输送系统上，而非直接通过裸支架传递，保证覆膜支架起始端的定位精确，可以避免具多圈裸支架结构的管腔支架在支架释放过程中发生的裸支架波形凌乱、防止裸支架过度牵拉造成的破坏。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明一种管腔支架第一实施例的结构示意图；
图2是本发明的管腔支架第一实施例中定位装置与裸支架的连接示意图；
图3是本发明一种输送系统第一实施例的结构示意图；
图4是本发明的输送系统第一实施例中锚定部件的结构示意图；
图5是本发明图1所示的处于释放状态的管腔支架与图3所示的输送系统的装配示意图；
图6是本发明图1所示的管腔支架压缩在图3所示的输送系统的外鞘管中的装配示意图；
图7是本发明一种管腔支架第二实施例的结构示意图；
图8是本发明的管腔支架第二实施例中A部位的放大图；
图9是本发明一种输送系统第二实施例的结构示意图；
图10是本发明图7所示的管腔支架与图9所示的输送系统的装配示意图；
图11是本发明图10中B部位的放大图；
图12是本发明图7所示的管腔支架处于完全释放状态下与图9所示的输送系统的装配示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
第一实施例：
如图1所示，一种管腔支架100包括可在其径向被压缩且压缩后能恢复形态的覆膜支架110和与覆膜支架110相连的裸支架120。覆膜支架110包括网状的支架主体111和包覆于支架主体111上的覆膜112。网状的支架主体111包括多个沿该管腔支架100的轴向间隔排布的波圈。优选地，波圈采用镍钛丝编织定型而成，覆膜112使用涤纶材料缝合在支架主体111上。
裸支架120包括与覆膜支架110起始端相连的网状延长段121、与延长段121相连的波形环状物122以及固定于波形环状物122波峰上的倒刺123。网状的延长段121包括多个沿轴向间隔排布的小波圈，波形环状物122为单圈大波圈。同样的，波形环状物122可采用镍钛丝编织定型而成。在其它可能的实施例中，网状延长段也可以由金属材料一体切割形成或采用金属丝编织形成。波形环状物122的波峰与波峰之间、或波谷与波谷之间的距离大于裸支架120 中小波圈波峰与波峰之间、或波谷与波谷之间的距离。且波形环状物122的波谷与处于近端的小波圈的波峰相连。裸支架120的延长段121能够提高管腔支架100的贴壁性和锚定力。
该管腔支架100还包括固定于覆膜支架110近端起始端的定位装置130。定位装置130包括设于覆膜支架110近端起始端的固定端131、自固定端131延伸的连接段132以及设于连接段132末端的定位端133。在该实施例中，定位装置130为在轴向具有较低的伸长率并具有柔性的绳状结构。具体来说，定位装置130可以是金属丝或塑料绳，优选地，定位装置130可以采用聚丙烯缝合线或PTFE缝合线。之所以采用在轴向不可伸长的材料，是为了保证管腔支架100在释放过程中，随着外鞘管的后撤，定位装置130能牢牢牵扯住覆膜支架110的近端起始端，从而使之始终保持在特定的位置。
定位装置130的固定端131可以通过缝合、打结或焊接的方式与覆膜支架110的近端起始端牢固结合。如图2所示，连接段132交错穿设于若干个延长段121的小波圈之间，裸支架120在展开并与血管壁贴合的状态下，绳状的定位装置130被压在裸支架130和血管壁之间，从而防止绳状的定位装置130漂浮在血液中，降低血栓产生的风险。位于连接段132末端的定位端133为一环状结构，用于与输送系统的锚定部件活动相连。环状结构可以通过缝合、打结或焊接的方式形成，可以理解的，定位端133也可以是勾状结构，只要能与锚定部件形成活动连接即可。可以理解的是，定位端133必须与锚定部件活动连接，以方便管腔支架100在完全释放之后，定位装置130能与输送系统及时脱离。
如图3所示，本发明还提出了一种输送系统200，其包括外鞘管201、设于外鞘管201内并可相对于外鞘管201轴向滑动的推杆202、与推杆202远端相连的外芯管203、与外芯管203的远端相连的锚定部件204、穿过锚定部件204和外芯管203并可沿轴向滑动的内芯管205、套设于内芯管2056外并可沿轴向滑动的固定帽206和端头207。
如图4所示，锚定部件204包括固定在外芯管203远端的锥状体204A和自锥状体204A的较大端向远端延伸的柱状体204B。锥状体204的周向分布有 若干个限位件，该限位件包括第一限位件2041和第二限位件2042。柱状体204B的周向均匀间隔设置有若干个容置槽2044以及由任意相邻两个容置槽2044之间的部位形成的分隔部2045。第一限位件2041的远端有部分延伸至容置槽内并具有与分隔部2045共圆周面的台阶部2043。而第二限位件2042的远端与分隔部2045的近端抵接，且第二限位件2042在径向上的高度大于分隔部2045在同方向上的高度从而形成止挡部2046。
如图6所示，管腔支架100在被输送至人体血管的病变部位之前被压缩在外鞘管201内，其裸支架120的波形环状物122的波峰勾挂于第一限位件2041台阶部2043的远端，而设于波峰上的倒刺123被收容在容置槽2044内。定位装置130的定位端133同样勾挂于台阶部2043的远端，固定帽206向近端滑动直至由第二限位件2042与分隔部2045形成的止挡部2046为止，从而与锚定部件204的柱状体204B形成用来锁定裸支架120近端的封闭空间。此时，绳状的定位装置130处于绷直状态且不可伸长，由此与定位装置130的固定端131相连的覆膜支架110的近端起始端不能移动。
如图5所示，当管腔支架100被输送至血管内的病变位置后，外鞘管201在输送系统手柄(未示出)的操作下往图中的箭头D1所指的方向后撤，在外鞘管201后撤过程中，外鞘管201与管腔支架100之间的摩擦力会通过定位装置130的连接段132传递到锚定装置204，因此避免了由于摩擦力通过裸支架120的小波圈直接传递造成的波圈形态凌乱。尤其在大动脉覆膜支架产品中，往往为了追求更细的鞘管直径，生产商一般会把管腔支架压缩得更加紧密，从而有利于装进更小的鞘管内，这样在释放过程中，鞘管和管腔支架之间的摩擦力往往很大。但是本发明通过定位装置130将摩擦力传递给输送系统200的锚定部件204，避免了外鞘管201在后撤过程中造成的裸支架波形凌乱。
外鞘管201沿D1方向一直后撤，直至覆膜支架110完全释放，此时，由于定位装置130的牵拉作用，覆膜支架110的近端起始端始终处于最初的位置，而且由于定位装置130在轴向方向具有很低的伸长率，因此可以保证在外鞘管201后撤过程中产生的极大摩擦力下，覆膜支架110的近端起始端定位依然精准。待覆膜支架110完全释放之后，固定帽206和端头207在输送系统手柄的 操作下沿图中的D2方向后撤，直至裸支架120被完全释放，此时整个管腔支架100与血管内壁紧密贴合，裸支架120近端的倒刺123刺入血管壁内从而增加与血管壁的锚定力。由于管腔支架100已经与血管壁紧密贴合，因此可以通过操作输送系统200手柄上的滑块机构操作外芯管203向近端移动，从而使得定位装置130的定位端133即环状结构与锚定部件204的第一限位件2041脱离，至此整个管腔支架100与输送系统200脱离。
本发明与现有的具有近端后释放功能的支架系统相比，本发明通过在管腔支架上设置定位装置，保证了覆膜支架近端起始端始终定位精准，不会由于外鞘管的后撤产生的摩擦力导致覆膜支架近端起始端定位失效。且定位装置还能使管腔支架(主要是覆膜支架)与外鞘管内壁产生的摩擦力(支架释放阻力的主要来源)传递到输送系统的锚定部件上，而非直接通过裸支架传递，可以避免具多圈裸支架结构的管腔支架在支架释放过程中发生的裸支架波形凌乱和裸支架过度牵拉造成的破坏。
第二实施例：
如图7所示，一种管腔支架300包括可在其径向被压缩且压缩后能恢复形态的覆膜支架310和与覆膜支架310相连的裸支架320。覆膜支架310包括网状的支架主体311和包覆于支架主体311上的覆膜312。网状的支架主体311包括多个沿该管腔支架100的轴向间隔排布的波圈。优选地，波圈采用镍钛丝编织定型而成，覆膜312使用涤纶材料缝合在支架主体311上。
裸支架320包括与覆膜支架310起始端相连的网状延长段321、与延长段321相连的波形环状物322以及固定于波形环状物322波峰上的倒刺323。网状的延长段321包括多个沿轴向间隔排布的小波圈，波形环状物322为单圈大波圈。同样的，波形环状物122可采用镍钛丝编织定型而成。在其它可能的实施例中，网状延长段也可以由金属材料一体切割形成或采用金属丝编织形成。波形环状物122的波峰与波峰之间、或波谷与波谷之间的距离大于小波圈波峰与波峰之间、或波谷与波谷之间的距离。大波圈的波谷与处于近端的小波圈的波峰相连。在其它可能的实施例中，网状延长段也可以由金属材料一体切割形成或采用金属丝编织形成。裸支架320的延长段321能够提高管腔支架300的 贴壁性和锚定力。
该管腔支架300还包括固定于覆膜支架310近端起始端的定位装置330。在本实施例中，定位装置330为一闭合的定位环。定位装置330可以由金属丝或塑料绳制成，优选地，可以采用聚丙烯缝合线或PTFE缝合线缝合、打结或焊接形成。如图8所示，定位环包括与覆膜支架310的近端起始端固定的固定点331以及封闭的环体332。环体332与输送系统的锚定部件活动相连。可以理解的，环体332也可以是勾状结构，只要能与锚定部件形成活动连接即可。裸支架320在展开并与血管壁贴合的状态下，定位装置330被压在裸支架330和血管壁之间，从而防止定位装置330漂浮在血液中，降低血栓产生的风险。
如图9所示，本实施例中的输送系统400包括外鞘管401、设于外鞘管401内并可相对于外鞘管401轴向滑动的推杆402、与推杆402远端相连的外芯管403、与外芯管403的远端相连的锚定部件404、穿过锚定部件404和外芯管403并可沿轴向滑动的内芯管405、套设于内芯管405外并可沿轴向滑动的固定帽406和端头407。
在该实施例中，外芯管403包括外套管4031和内套管4032。锚定部件404包括近端固定锚4041和远端固定锚4042。近端固定锚4042优选金属材料，如采用不锈钢加工而成，以提供足够的强度和锚定力。外套管4031的近端与推杆402的远端相连，外套管4031的远端与输送系统400手柄上的控制滑块(未标示)相连。通过操控外套管4031沿着内套管4032轴向滑动，可以实现近端固定锚4041的轴向移动。内套管4032穿过近端固定锚4041和外套管4031并可相对于两者轴向滑动，远端固定锚4042固定于内套管4032的远端。内芯管405穿过远端固定锚4042和内套管4032并可相对于两者轴向滑动。
如图11所示，近端固定锚4041包括与外套管4031的远端相连的主体以及沿主体周向分布的勾体4043，优选地，沿主体的周向分布有至少两个勾体4043。远端固定锚4042与第一实施例中的锚定部件204结构相同，其同样包括固定在内套管4032远端的锥状体和自锥状体的较大端向近端延伸的柱状体。锥状体的周向分布有若干个限位件，限位件包括第一限位件和第二限位件。柱状体的周向均匀间隔设置有若干个容置槽以及由任意相邻两个容置槽之间 的部位形成的分隔部。第一限位件的远端有部分延伸至容置槽内并具有与分隔部共圆周面的台阶部。而第二限位件的远端与分隔部的近端抵接，且第二限位件在径向上的高度大于分隔部在同方向上的高度从而形成止挡部。
如图10所示，管腔支架300在被输送至人体血管的病变部位之前被压缩在外鞘管401内，其裸支架320波形环状物322的波峰勾挂于第一限位件台阶部的远端，而设于波峰上的倒刺323被收容在容置槽内。定位装置330的环体332勾挂于近端固定锚4041的勾体4043上，固定帽406向近端滑动直至由第二限位件与分隔部形成的止挡部为止，从而与远端固定锚4042的柱状体形成用来锁定裸支架320近端的封闭空间。而覆膜支架310的近端起始端始终被限制在近端固定锚4041所在的位置，
当管腔支架300被输送至血管内的病变位置后，外鞘管301在输送系统手柄(未示出)的控制下后撤，在外鞘管301后撤过程中，由于远端固定锚4042和近端固定锚4041相对静止，裸支架320被限制在远端固定锚4042和近端固定锚4041之间，而且，覆膜支架310与外鞘管401之间的摩擦力会通过定位装置430传递给近端固定锚4041，而不会施加在裸支架320上，因此裸支架320不会发生牵拉伸长和变形，避免了由于摩擦力通过裸支架120的小波圈直接传递造成的波圈形态凌乱。
外鞘管401一直后撤，直至覆膜支架310完全释放，此时，由于覆膜支架310的近端起始端通过定位装置430固定在近端固定锚4041上，而且定位装置430在轴向方向具有很低的伸长率，因此可以保证在外鞘管401后撤过程中产生的极大摩擦力下，覆膜支架310的近端起始端定位始终精准。待覆膜支架310完全释放之后，固定帽406和端头407在输送系统的操作下后撤，直至裸支架320被完全释放，此时整个管腔支架300与血管内壁紧密贴合，裸支架320近端的倒刺323刺入血管壁内从而增加与血管壁的锚定力。由于管腔支架300已经与血管壁紧密贴合，因此可以通过操作输送系统400手柄上的滑块机构操作外套管4031向近端移动，从而使得定位装置330的环体332与近端固定锚4041脱离，至此整个管腔支架300与输送系统400脱离。
本发明与现有的具有近端后释放功能的支架系统相比，本发明中通过在管 腔支架上设置定位装置，使管腔支架(主要是覆膜支架)与外鞘管内壁产生的摩擦力(支架释放阻力的主要来源)传递到输送系统的锚定部件上，而非直接通过裸支架传递，可以避免具多圈裸支架结构的管腔支架在支架释放过程中发生的裸支架波形凌乱和裸支架过度牵拉造成的破坏。同时，定位装置在管腔支架释放过程中，还能够保证覆膜支架近端起始端的定位精确。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (17)

  1. 一种管腔支架，其包括覆膜支架和与所述覆膜支架近端相连的裸支架，其特征在于，该管腔支架还包括在轴向不可伸长的定位装置，所述定位装置固定于所述覆膜支架的近端起始端。
  2. 根据权利要求1所述的管腔支架，其特征在于，所述定位装置包括设于所述覆膜支架近端起始端的的固定端、自所述固定端延伸的连接段以及设于所述连接段末端的定位端。
  3. 根据权利要求2所述的管腔支架，其特征在于，所述定位装置为细长的绳状结构，所述定位端为设于所述绳状结构末端的环形部件。
  4. 根据权利要求3所述的管腔支架，其特征在于，所述裸支架包括与所述覆膜支架相连的延长段以及与所述延长段相连的波形环状物，所述绳状结构至少有部分固定在所述延长段上。
  5. 根据权利要求4所述的管腔支架，其特征在于，所述延长段包括若干沿轴向排布的小波圈，所述连接段至少有部分交替穿设于若干个所述小波圈之间。
  6. 根据权利要求4所述的管腔支架，其特征在于，所述延长段为编织的网管状结构，所述连接段至少有部分交替穿设于所述网管状结构中。
  7. 根据权利要求4所述的管腔支架，其特征在于，所述波形环状物的波峰上还设有倒刺。
  8. 根据权利要求1所述的管腔支架，其特征在于，所述定位装置为固定于所述覆膜支架近端起始端的闭合定位环。
  9. 根据权利要求8所述的管腔支架，其特征在于，所述闭合定位环包括设置在所述覆膜支架近端起始端上的固定点以及自固定端延伸的闭合环体。
  10. 根据权利要求1-9任一项所述的管腔支架，其特征在于，所述定位装置由塑料绳或金属丝制成。
  11. 根据权利要求10所述的管腔支架，其特征在于，所述定位装置由塑料绳制成，所述塑料绳为聚丙烯缝线或PTFE缝合线。
  12. 一种用于输送如权利要求1-11任一项所述的管腔支架的输送系统， 其特征在于，其包括用于收容所述管腔支架的外鞘管、用于推出所述管腔支架的推杆、与所述推杆相连的外芯管、与所述外芯管相连的锚定部件、穿过所述锚定部件和所述外芯管并可相对于所述外芯管轴向滑动的内芯管以及套设在所述内芯管外并可相对于所述内芯管轴向滑动的固定帽和端头。
  13. 根据权利要求12所述的输送系统，其特征在于，所述锚定部件包括与所述推杆远端相连的锥状体和自所述锥状体的较大端延伸的柱状体，所述锥状体的周向分布有限位件，所述柱状体周向间隔分布有容置槽，任意相邻两个所述容置槽之间形成分隔部，所述柱状体插入所述固定帽内，所述容置槽与所述固定帽的内侧壁形成用于锁定所述管腔支架近端的封闭空间。
  14. 根据权利要求12所述的输送系统，其特征在于，所述外芯管包括与外套管和内套管，所述锚定部件包括近端固定锚和远端固定锚，所述外套管近端与所述推杆的远端相连，所述外套管的远端与所述近端固定锚相连，所述内套管穿过所述近端固定锚和所述外套管并可相对于两者轴向滑动，所述内套管的远端与所述远端固定锚相连。
  15. 根据权利要求14所述的输送系统，其特征在于，所述近端固定锚包括与所述外套管远端相连的主体和沿所述主体周向分布的勾体。
  16. 根据权利要求14所述的输送系统，其特征在于，所述远端固定锚包括与所述内套管远端相连的锥状体和自所述锥状体的较大端延伸的柱状体，所述锥状体的周向分布有限位件，所述柱状体周向间隔分布有容置槽，任意相邻两个所述容置槽之间形成分隔部，所述柱状体插入所述固定帽内从而形成用于锁定所述波形环状物的封闭空间。
  17. 根据权利要求13或16任一项所述的输送系统，其特征在于，所述限位件包括沿所述锥状体周向交错分布的第一限位件和第二限位件，所述第一限位件用于勾挂所述波形环状物的波峰且其远端有部分位于所述容置槽内，所述第一限位件远端位于所述容置槽内的部分设有台阶部，所述台阶部与所述分隔部共圆周面并与所述固定帽抵接；所述第二限位件的远端与所述分隔部的近端抵接且其在径向上的高度大于所述分隔部在同方向上的高度从而形成用于限制所述固定帽向近端移动的止挡部。
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