WO2019011274A1 - 植入物的输送系统 - Google Patents

植入物的输送系统 Download PDF

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Publication number
WO2019011274A1
WO2019011274A1 PCT/CN2018/095273 CN2018095273W WO2019011274A1 WO 2019011274 A1 WO2019011274 A1 WO 2019011274A1 CN 2018095273 W CN2018095273 W CN 2018095273W WO 2019011274 A1 WO2019011274 A1 WO 2019011274A1
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WO
WIPO (PCT)
Prior art keywords
tube
inner sheath
core tube
sheath core
locking portion
Prior art date
Application number
PCT/CN2018/095273
Other languages
English (en)
French (fr)
Inventor
王逸斐
肖本好
Original Assignee
先健科技(深圳)有限公司
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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 WO2019011274A1 publication Critical patent/WO2019011274A1/zh

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

Definitions

  • the present invention relates to implantable medical devices, and in particular to delivery systems for implants.
  • luminal stent intervention For diseases such as vascular stenosis, aneurysm and vascular dissection, luminal stent intervention has the advantages of less trauma, quick recovery, less complications, and better therapeutic effect.
  • the metal skeleton structure of the self-expanding stent lumen stent is usually made of Nitinol, and after the heat setting process, the lumen stent has the ability to restore its shape.
  • the tube of the delivery system of such a stent generally comprises an outer sheath tube and an inner sheath core tube pre-installed in the outer sheath tube.
  • the proximal end of the inner sheath core tube is thicker and the distal end is thinner.
  • the lumen bracket is received in the cavity between the outer sheath tube and the distal end portion of the inner sheath core tube, and the distal end of the stent and the inner sheath core tube are thicker.
  • the distal end face of the portion is in close contact with the inner sheath core tube for connecting the seeker (or tip) and receiving and passing the guide wire.
  • the blood vessel shape is bent and the lumen stent is also easily displaced. Will affect the subsequent release, and when the outer sheath is removed, the stent will be easily displaced, resulting in unsatisfactory release position, which will affect the therapeutic effect.
  • this delivery system still has the following defects: (1) during the delivery of the lumen stent, when the outer sheath tube and the sheath core tube together pass through the curved portion of the human lumen, the bending radius of the curved blood vessel is smaller.
  • the gap between the sheath core tube and the outer sheath tube is reduced; on the side of the curved radius of the curved blood vessel, the gap between the sheath core tube and the outer sheath tube is increased, and at this time, the rigid protrusion and the outer portion
  • the distance between the inner walls of the sheath is increased, the rigid protrusions are easily separated from the lumen stent, and the lumen stent may be separated from the protrusions, thereby causing the position of the lumen stent to be displaced in the outer sheath tube, affecting Subsequent release.
  • the lumen stent When the sheath core tube and the outer sheath tube reach the lesion site, when the operator withdraws the outer sheath tube and releases the lumen stent, the lumen stent may be completely released from the outer sheath tube quickly, and if the release position is not ideal, it cannot be Adjust the release position. (3) When the lumen stent is partially released from the outer sheath tube, if the release position of the lumen stent is found to be unsatisfactory, the distal position of the outer sheath tube needs to be adjusted, and the lumen stent may be sheathed during the adjustment process. The tube was completely released in advance.
  • the implant delivery system that secures the implant to the sheath core tube even within a curved vessel. Avoid offset between the implant and the inner sheath core. Moreover, the implant can be gradually released during the release process, avoiding the disadvantage of not being able to adjust the release position after the sudden release of the implant, and avoiding the complete release of the implant in advance during the adjustment of the release position of the release implant.
  • the delivery system of the implant comprises an inner sheath core tube and an outer sheath tube movably sleeved outside the inner sheath core tube and having a cavity.
  • the delivery system also includes at least one anchoring unit secured to an outer surface of the inner sheath core tube.
  • the anchoring unit includes a clamping member sleeved on an outer surface of the inner sheath core tube and at least one anchoring member connected to the fastening member.
  • the anchor includes a deformable portion that is bendable relative to the inner sheath core tube and a locking portion that is coupled to the deformed portion.
  • the deformation portion and the locking portion cooperate with the fastening member to form an anchor when being received in a cavity between the outer sheath tube and the inner sheath core tube.
  • the anchor can hook the implant and limit the implant Relative movement with the inner sheath core tube.
  • the elastic deformation amount of the locking portion is smaller than the elastic deformation amount of the deformation portion.
  • the elastic modulus of the material from which the locking portion is made is less than or equal to the elastic modulus of the material from which the deformation portion is made.
  • the diameter of the locking portion is greater than or equal to the diameter of the deformation portion.
  • the locking portion is a hollow tubular body or a spherical body that is sleeved at a distal end portion of the deformation portion.
  • the length of the locking portion along the axial direction of the inner sheath core tube is larger than the tightening member and the outer sheath tube The gap between them.
  • the length of the locking portion is greater than 0.1 mm and less than 15 mm when the inner sheath core tube is received in the outer sheath tube.
  • the anchor further includes a fixing portion coupled between the fastening member and the deformation portion.
  • the anchoring unit comprises from 1 to 12 anchors.
  • the 1 to 12 anchors are symmetrically or asymmetrically disposed about a central axis of the inner sheath core tube.
  • the outer surface of the hoop member or the outer surface of the inner sheath tube is provided with a receiving space for receiving the locking portion and the deformation portion.
  • the inner diameter of the inner sheath tube near the distal end is larger than the inner diameter of the inner sheath tube near the proximal end, and the anchoring member of the anchoring unit is embedded in the inner sheath tube Between the distal end of the tube body and the inner sheath core tube.
  • the length of the locking portion along the axial direction of the inner sheath core tube is larger than the inner sheath core tube and the outer sheath The gap between the tubes.
  • the delivery system for an implant comprises an inner sheath core tube, and an outer sheath tube movably sleeved on the outer portion of the inner sheath core tube having a cavity; the delivery system further comprising a fixing inside At least one anchoring unit of the outer surface of the sheath core tube, the anchoring unit comprising at least one anchor attached to the inner sheath core tube, the anchor comprising a bendable relative to the inner sheath core tube a deforming portion and a locking portion connected to the deforming portion, wherein the deforming portion and the locking portion are received in a cavity between the outer sheath tube and the inner sheath core tube, and the inner portion
  • the sheath core tube cooperates to form an anchor.
  • the length of the locking portion along the axial direction of the inner sheath core tube is larger than the inner sheath core tube and the outer sheath tube The gap between them.
  • the delivery system of the present invention provides an anchoring member instead of a rigid protrusion on the inner sheath core tube to restrain the lumen stent, and has at least the following beneficial effects:
  • the locking portion of the anchor member is bent through the end of the implant, and the deformed portion of the anchor member is bent toward the inner sheath core tube And is constrained between the inner sheath core tube and the outer sheath tube, even when passing through the relatively curved body lumen portion, the anchor member is not detached from the implant, and the prior art rigid protrusions are avoided.
  • a gap is created between the inner walls of the outer sheath tube, causing the implant to fall off from the rigid protrusions.
  • the locking portion stops expanding outward and restricts the deformation portion from continuing to expand outward.
  • the entire anchor is in a steady state and the lumen stent is still secured to the inner sheath core via an anchor. Therefore, the delivery system of the present invention can effectively prevent the anchor from separating from the lumen stent when the tubular body passes over the curved vessel site.
  • the implant can be gradually released under the constraint of the outer sheath tube within the length of the locking portion until all the anchor members are exposed, thereby avoiding the disadvantage that the release position cannot be adjusted after the implant is suddenly released.
  • the operator can withdraw the body and adjust the distal position of the tube.
  • the implant is fixed on the inner sheath core tube. And the relative movement between the implant and the outer sheath tube does not occur, effectively preventing the implant from being released in advance from the outer sheath tube.
  • the portion near the proximal end of the implant is still fixed to the inner sheath core tube by the anchoring unit.
  • the distal end of the outer sheath tube can be re-recovered into the cavity between the outer sheath tube and the inner sheath core tube by driving the outer sheath tube to move axially distally relative to the inner sheath core tube, and then the tube The body is withdrawn from the patient and replaced with an appropriately sized implant.
  • 1a to 1c are front views of a lumen stent delivery system according to a first embodiment, the delivery system includes a handle, a tube body and an anchoring unit, and the tube body comprises an outer sheath tube, an inner sheath core tube and an inner sheath tube, wherein 1a is a schematic view of the anchoring unit, the inner sheath core tube and the inner sheath tube being housed in the outer sheath tube, and FIG. 1b is a schematic view showing the anchor unit, the inner sheath core tube and the inner sheath tube not being housed in the outer sheath tube, FIG. 1c is a partial enlarged view of A in Fig. 1b;
  • FIG. 2a and 2b are schematic structural views of the anchoring unit of FIG. 1b, the anchoring unit includes four anchoring members and a tightening member, wherein FIG. 2a is a schematic view of the anchoring unit not being received in the outer sheath tube, Figure 2b is a schematic view of the anchoring unit housed in the outer sheath tube;
  • FIG. 3a and 3b are partial cross-sectional views of the anchoring unit and the tubular body of Fig. 1c in a section parallel to the axial direction of the tubular body, wherein Fig. 3a is the anchoring member housed in the tubular body, the deformation portion and the locking FIG. 3b is a schematic view showing the deformation of the deformation portion and the locking portion along the radial outward direction of the inner sheath core tube;
  • FIG. 4a is a schematic structural view of another embodiment of an anchoring unit
  • 4b is a schematic structural view of another embodiment of an anchoring unit
  • Figure 5 is a schematic structural view of another embodiment of the pipe body
  • FIG. 6a to 6d are schematic structural views of an anchoring unit in a conveying system according to a second embodiment, the anchoring unit includes a tightening member and an anchoring member, wherein Fig. 6a is a front view of the anchoring unit, and Fig. 6b is a front view Figure 6c is a schematic view showing the manner in which the anchoring member and the tightening member are combined, and Figure 6d is a schematic view showing the anchoring unit being received in the outer sheath tube;
  • Figure 7 is a partial cross-sectional view of the anchoring unit in a section parallel to the axial direction of the tubular body when the anchoring unit of Figure 6d is received in the outer sheath tube;
  • Figure 8a and Figure 8b show the loading of the lumen stent to the second embodiment Schematic diagram of the process in the outer sheath tube, wherein FIG. 8a is a schematic view showing the connection of the lumen stent to a part of the anchoring member, and FIG. 8b is a schematic view showing the lumen stent being connected to all the anchoring members and gradually being accommodated into the outer sheath tube;
  • FIG. 9a and 9b are schematic views of an anchoring unit in a conveying system according to a third embodiment, wherein FIG. 9a is a front view of the anchoring unit; FIG. 9b is a front view of an intermediate product in the manufacturing process of the anchoring unit;
  • Figure 10 is a cross-sectional view of the distal end section of the anchoring unit and the inner sheath tube in a section parallel to the axial direction of the inner sheath tube in the delivery system provided by the third embodiment;
  • Figure 11 is a schematic view showing the process of embedding the anchoring unit of Figure 9a in the distal end section of the inner sheath tube;
  • FIG. 12a and 12b are schematic views of the distal end section of the anchoring unit and the inner sheath tube in the delivery system provided by the third embodiment, the distal end section of the inner sheath tube has a receiving groove and a receiving hole, wherein FIG. 12a is a deformation part and FIG. 12b is a schematic view showing a portion of the deformation portion and the locking portion being respectively received in the receiving groove and the receiving hole;
  • Figure 13a is a schematic view of the anchor member provided by the third embodiment
  • FIG. 13b and FIG. 13c are a front view of the anchoring unit provided in FIG. 13a after the deformation portion is completely deformed, and a cross-sectional view of the distal end section of the inner sheath core tube in a section parallel to the axial direction of the inner sheath core tube;
  • 14a, 14b and 14c are schematic views of the anchoring unit and the distal end section of the inner sheath core tube in the delivery system provided in the fourth embodiment;
  • Figure 14d is a cross-sectional view of the distal section of the inner sheath core tube in a section parallel to the axial direction of the inner sheath core tube;
  • Figure 15 is a cross-sectional view of the anchoring unit and the distal end section of the inner sheath core tube in a section parallel to the axial direction of the inner sheath core tube in the delivery system provided in the fifth embodiment.
  • an element when referred to as being “fixed” to another element, it can be directly on the other element or the element can be present. When an element is considered to be “connected” to another element, it can be directly connected to the other element or.
  • the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.
  • proximal and distal are defined herein as a common term in the field of interventional medicine. Specifically, in the field of interventional medicine, “distal” refers to the end away from the operator during the surgical procedure, and “proximal” refers to the end that is close to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning meaning The terminology used in the description is for the purpose of describing the particular embodiments, and is not intended to limit the invention.
  • the delivery system 100 provided in the first embodiment is used for delivering the implant to a lesion in a lumen of a human body.
  • the delivery system 100 includes a tubular body 10, an anchoring unit 20, and a handle 30.
  • the implant is a lumen stent 200.
  • the handle 30 includes a first housing 31 and a second housing 32 that are symmetrically disposed.
  • the first housing 31 and the second housing 32 are axially movable relative to each other, and the first housing 31 is closer to the distal end than the second housing 32.
  • the tubular body 10 includes a hollow inner sheath tube 11 extending axially through the handle 30, a hollow inner sheath core tube 13 extending through the inner sheath tube 11 and distally extending from the inner sheath tube 11, and movably sleeved on the inner sheath tube 11
  • An outer sheath tube 12 having a cavity between the outer and inner sheath core tubes 13 and a hollow tip 14 disposed at the distal end of the inner sheath core tube 13 and impervious to X-rays.
  • the compressed lumen stent 200 is loaded into the cavity between the distal end of the inner sheath core tube 13 and the distal end of the outer sheath tube 12 and is in frictional contact with the outer surface of the inner sheath core tube 13.
  • the inner sheath tube 11 is connected to the first housing 31.
  • the outer sheath tube 12 is connected to the second housing 32. Thereby, the operator can drive the outer sheath tube 12 to move in the axial direction relative to the inner sheath core tube 13 by operating the relative movement between the second housing 32 of the handle 30 and the first housing 31, and withdraw to the proximal end.
  • the outer sheath 12 ultimately causes the lumen stent 200 to be released from the outer sheath 12.
  • the handle can be other structures.
  • a slider can be disposed on the handle that is vertically connected to the outer sheath tube 12. The operator can drive the axial movement of the outer sheath tube 12 by dragging the slider.
  • the inner sheath tube 11 extends axially through the proximal end face and the distal end face of the handle 30.
  • the inner sheath tube 11 is fixedly coupled to the inner sheath core tube 13 located inside the inner sheath tube 11.
  • the manner of fixing the connection may be a technical means commonly used in the art such as welding, bonding, sewing, hot-melting or screwing, and will not be described in detail herein.
  • the inner sheath tube 11 is made of a polymer material having toughness. It can be understood that in other embodiments, the inner sheath tube 11 can also be made of a metal material.
  • the inner sheath tube 11 can also be a combination of a tube body made of a polymer material and a tube body made of a metal material.
  • the tube portion of the inner sheath tube 11 near the distal end is housed in the outer sheath tube 12, and is made of a tough polymer material to facilitate the passage of the inner sheath tube 11 in the curved human lumen.
  • the tube portion of the inner sheath tube 11 near the proximal end is located inside the handle 30 and is made of a metal material to improve the support of the proximal end of the inner sheath tube 11.
  • the outer sheath tube 12 is sleeved on the outside of the inner sheath tube 11 and the inner sheath core tube 13, and is axially movable relative to the inner sheath tube 11 and the inner sheath core tube 13 under the driving of the handle 30.
  • the lumen stent 200 can be received into the outer sheath tube 12; when the outer sheath tube 12 is driven toward the proximal end, the lumen stent 200 can be realized from the outer sheath tube 12 Released in.
  • the outer sheath tube 12 is made of a tough polymer material or a metal material.
  • a stiffer reinforcing tube (not shown) may be placed on the outer side of the outer sheath tube 12 near the proximal end, or a stiffer tube and outer sheath tube having a higher hardness may be placed.
  • the proximal ends of 12 are axially connected. Thereby, the passage of the outer sheath tube 12 in the handle 30 can be improved.
  • the tube body of the inner sheath core tube 13 near the proximal end is housed in the inner sheath tube 11.
  • the tube body of the inner sheath tube 13 housed in the inner sheath tube 11 and the inner sheath tube 11 are fixed together by a common connection method in the field such as welding, bonding, sewing, hot-melting or screwing to improve the inner sheath core.
  • the compressed lumen stent 200 is loaded into a cavity formed between the inner sheath core tube 13 and the outer sheath tube 12 which is not surrounded by the inner sheath tube 11.
  • the distal end of the inner sheath core tube 13 is connected to a radiopaque hollow Tip head 14 which may be connected by injection molding or bonding.
  • the lumen of the inner sheath core tube 13 communicates with the lumen of the Tip head 14.
  • the inner sheath core tube 13 and the inner cavity of the Tip head 14 are for receiving and passing through a guide wire (not shown).
  • the conveyor may not include the inner sheath tube 11.
  • the anchoring unit 20 is disposed on the outer surface of the tubular body in which the inner sheath core tube 13 is not wrapped by the inner sheath tube 11.
  • the anchoring unit 20 includes a tightening member 21 that is sleeved on the outer surface of the inner sheath core tube 13 and at least one anchoring member 22 that is coupled to the tightening member 21.
  • the number of anchors 22 is four.
  • the four anchors 22 are symmetrically disposed about the central axis of the inner sheath core tube 13. It will be appreciated that in other embodiments, the anchors 22 may also be asymmetrically disposed about the central axis of the inner sheath core tube 13.
  • Each of the anchors 22 includes a deformation portion 221 that is coupled to the fastening member 21 and that is bendable relative to the fastening member 21, and a locking portion 222 that is coupled to the deformation portion. Since the outer sheath tube 12 can move axially relative to the inner sheath core tube 13, the deformation portion 221 and the locking portion 222 of the anchoring member 22 are movably received in the space formed between the outer sheath tube 12 and the inner sheath core tube 13. In the cavity (as shown in Figure 2b).
  • the deformation portion 221 is bent toward the proximal end, and the deformation portion 221 and the locking portion 222 are pointed.
  • the proximal end and the inner sheath core tube 13 cooperate to form an anchor.
  • a plurality of anchors hook the hollow proximal end of the lumen stent 200 (i.e., the skeleton at the trough) to secure the lumen stent 200 to the inner sheath core tube 13.
  • the anchor member 22 when the outer sheath tube 12 is axially moved relative to the inner sheath core tube 13, the anchor member 22 is gradually released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, the deformation portion.
  • the 221 and the locking portion 222 are deployed outward in the radial direction of the inner sheath core tube 13, returning to the naturally deployed state, and being separated from the lumen holder 200.
  • the catheter stent 200 is released from the anchoring member 22, it is finally completely released from the outer sheath tube 12 and deployed to cover the vessel wall.
  • the deformation portion 221 is made of a flexible material (for example, a polymer material such as polytetrafluoroethylene), a metal material having a certain hardness (for example, a metal material such as stainless steel or a polymer material such as polyether block amide), or a material having elasticity. (made of alloy materials such as nickel-titanium alloy). Therefore, when subjected to an external force, the deformation portion 221 can be deformed to some extent.
  • a flexible material for example, a polymer material such as polytetrafluoroethylene
  • a metal material having a certain hardness for example, a metal material such as stainless steel or a polymer material such as polyether block amide
  • a material having elasticity for example, a metal material such as stainless steel or a polymer material such as polyether block amide
  • alloy materials such as nickel-titanium alloy
  • the hardness of the material forming the locking portion 222 is greater than the hardness of the material forming the deformation portion 221, whereby the deformation amount of the locking portion 222 is smaller than the deformation amount of the deformation portion 221 when the deformation portion 221 and the locking portion 222 are subjected to the same external force. .
  • the difference in the deformation amount causes the locking portion 222 to be deformed when the deformation portion 221 is deformed by the external force during the transportation of the lumen holder 200, so that after the locking portion 222 contacts the inner wall of the outer sheath tube 12, It will stop expanding radially outward along the inner sheath core tube 13, and the connection between the anchor 22 and the lumen support 200 can be continued to avoid connection failure.
  • the deforming portion 221 is made of a nickel-titanium alloy having a shape memory function.
  • the locking portion 222 is made of stainless steel.
  • the length L1 of the locking portion 222 along the axial direction of the inner sheath core tube 13 is larger than the gap between the inner sheath core tube 13 and the outer sheath tube 12.
  • the purpose of this arrangement is to form an anchor to hook the skeleton of the lumen holder 200 when the deformation portion 221 is bent and cooperate with the locking portion 222 and the inner sheath core tube 13. If a disconnection is required between the lumen stent 200 and the anchor 22, the locking portion 222 is required to expand outwardly to return to a natural state. The locking portion 222 needs a certain space to expand outward.
  • the space should be at least equal to the length L1 of the locking portion 222. Therefore, in the present invention, the length L1 of the locking portion 222 is set to be larger than the gap between the inner sheath core tube 13 and the outer sheath tube 12. w, the locking portion 222 cannot be deployed outward when received in the outer sheath tube 13, which ensures a more reliable connection between the anchor member 22 and the lumen holder 200.
  • the length L1 of the locking portion 222 in the axial direction of the inner sheath core tube 13 is 5 mm. .
  • the deformation portion 221 and the locking portion 222 also require a cavity from the outer sheath tube 12 and the inner sheath core tube 13 during the release of the lumen stent 200. The middle is released, so that the arrangement can prevent the locking portion 222 from being scratched from the outer sheath tube 12 and then scraping the blood vessel.
  • the length L1 of the locking portion 222 is less than one-half of the inner diameter of the blood vessel at the release position, and mutual interference between the plurality of anchors 22 can be avoided. The separation of the anchor 22 from the lumen support 200 is affected.
  • the design of the length L1 of the locking portion 222 may be different according to the inner diameter of the release blood vessel.
  • the length L1 of the locking portion 222 should be greater than 0.1 mm and less than 15 mm. In the locked state, the locking portion 222 is not easily accidentally dislodged due to uncontrollable deformation, and the locking portion 222 is prevented from being damaged by the excessive length of the inner wall of the blood vessel when unlocked.
  • the diameter of the locking portion 222 is greater than or equal to the diameter of the deformation portion 221 .
  • the locking portion 222 and the deforming portion 221 may be a single filament having the same diameter, and the two may be connected together by a method commonly used in the art such as laser welding, bonding, or the like, or may be a whole, like one or the same metal.
  • the wire (not limited to), the locking portion 222 and the deformation portion 221 exhibit different mechanical properties by different heat treatment processes.
  • the locking portion 222 may also be a tubular body or a spherical body that is sleeved at the distal end of the deforming portion 221 to further ensure that when the deforming portion 221 and the locking portion 222 are subjected to the same external force, the elastic deformation of the deforming portion 221 is greater than The elastic shape variable of the locking portion 222.
  • each anchoring unit may include only one anchor. It will also be appreciated that in other embodiments, each anchoring unit may also include a greater number of anchors to increase the robustness of the anchoring unit to the lumen support. However, in order to ensure that the diameter of the tube can smoothly pass through the curved body lumen, the number of anchors should be less than or equal to 12.
  • the fastening member 21 is sleeved on the outer surface of the inner sheath core tube 13 and bonded, interference fit, stitched, heat-melted or welded to the outer surface of the inner sheath core tube 13 (for example, laser spot welding) is fixedly connected.
  • the fastening member 21 is fixed to the outer surface of the inner sheath core tube 13 by adhesion.
  • the tightening member 21 is a sleeve having a certain wall thickness.
  • the inner diameter of the tightening member 21 is greater than or equal to the outer diameter of the inner sheath core tube 13.
  • the outer diameter of the hoop member 21 is smaller than the inner diameter of the outer sheath tube 12.
  • the hoop member 21 may be made of a polymer material or a metal material.
  • the anchor 22 can also include a securing portion 223 (shown in Figure 4a) that is coupled between the tightening member 21 and the deformation portion 221.
  • the tube wall of the fastening member 21 has a through hole in the axial direction.
  • the length of the tightening member 21 in the axial direction of the inner sheath core tube 13 is smaller than the length of the fixing portion 223 in the axial direction of the inner sheath core tube 13.
  • the fixed portion 223 of the anchoring member 22 is axially penetrated through the through hole 212, the fixed portion 223 is separated from the end of the deforming portion 221 by laser spot welding to form a sphere, and the diameter of the sphere is larger than the diameter of the through hole to ensure that the fixing portion 223 is not Will fall off the self-tightening member 21.
  • the fixing portion 223 and the deforming portion 221 may be made of the same material or may be made of different materials, and the deformation portion 221 may be detachably connected to the lumen bracket 200 as long as it is made of a material having elasticity.
  • the fixing portion 223 should be made of a material having a certain hardness.
  • the fastening member 21 and the securing portion 223 of the anchor 22 may have other connections.
  • the tube wall of the hoop member 21 has a blind hole in the axial direction.
  • the length of the tightening member 21 in the axial direction of the inner sheath core tube 13 is larger than the length of the fixing portion 223 in the axial direction of the inner sheath core tube 13.
  • the clasp member 21 may be in the form of a sheet having a thin wall thickness.
  • the fixing portion 223 of the anchor member 22 is located on the inner wall of the fastening member 21 and is fixed to the fastening member 21 by heat fusion, welding, bonding or screwing (as shown in Fig. 4b). That is, the fixing portion 223 is located between the hoop member 21 and the outer surface of the inner sheath core tube 13. The relative movement between the fixing portion 223 and the outer surface of the inner sheath core tube 13 is restricted by the tightening member 21, thereby achieving the purpose of fixing the anchoring unit 20 to the inner sheath core tube 13.
  • the hoop member 21 may also be a hollow sleeve made of a heat shrinkable material.
  • the fixing portion 223 of the anchor 22 is disposed between the hoop member 21 and the outer surface of the inner sheath core tube 13.
  • the tightening member 21 is heat-shrinked and firmly wrapped around the inner sheath core tube 13, thereby restricting the fixing portion 223 of the anchoring member 22 and the inner sheath core tube 13 Relative movement occurs between the outer surfaces.
  • the tubular body 10 may not include the inner sheath tube 11.
  • the tubular body 10 includes a hollow inner sheath core tube 13 axially extending through the handle 30 (see FIG. 1a), an outer sheath tube 12 movably sleeved outside the inner sheath core tube 13, and A hollow Tip head 14 disposed at the distal end of the inner sheath core tube 13 and impervious to X-rays.
  • the inner sheath core tube 13 includes a first tube body 131 near the proximal end and a second tube body 132 axially connected to the distal end of the first tube body 131, and the diameter of the first tube body 131 is larger than that of the second tube body 132 diameter.
  • the compressed lumen stent 200 can be received in the cavity between the outer sheath tube 12 and the second tubular body 132 and in frictional contact with the second tubular body 132.
  • the anchoring unit 20 is disposed on the second tubular body 132 and detachably coupled to the lumen support 200 (see FIG. 1b). It can be understood that the first tube body 131 and the second tube body 132 can be made of different materials.
  • the first tube body 131 is made of a tough polymer material
  • the second tube body 132 is made of a metal material to ensure distal flexibility and proximal support of the inner sheath core tube 13.
  • the first tube body 131 and the second tube body 132 can also be made of the same material.
  • the first tube body 131 and the second tube body 132 are each made of a polymer material having toughness.
  • the inner sheath core tube 13 may also include a third tube (not shown). The third pipe body may be sleeved on the pipe body portion of the first pipe body 131 near the proximal end.
  • the third tube body may also be axially connected to the proximal end of the first tube body 131.
  • the hardness of the third pipe body is higher than the hardness of the first pipe body 131 to enhance the straightness and improve the proximal support of the inner sheath core pipe 13.
  • delivery system 100 may also include a three-way valve and hose fixedly mounted to handle 30 for delivery of irrigation fluid or contrast agent.
  • the operator can flush the outside of the inner sheath tube or discharge the air between the outer sheath tube and the inner sheath tube through the three-way valve and the hose to introduce the rinse liquid.
  • Digital contrast can also be performed by injecting a contrast agent through a three-way valve and a hose before or during surgery.
  • the lumen stent 200 needs to be loaded into the body 10 of the delivery system 100 prior to implantation in the patient, and then delivered by the delivery system 100 to the lesion in the patient.
  • the loading process of the lumen stent 200 is as follows: the lumen stent 200 is placed over the outer surface of the inner sheath core tube 13 and the deformed portion 221 and the locking portion 222 of the anchor 22 are passed through the lumen stent 200.
  • the locking portion 222 is then pressed in the direction of the inner sheath core tube 13, at which time the deformation portion 221 is deformed and bent relative to the inner sheath core tube 13, so that the locking portion 222, deformation
  • the portion 221 and the inner sheath core tube 13 cooperate to form an anchor, and the lumen holder 200 is hooked, and the lumen holder 200 is fixed to the outside of the inner sheath core tube 13.
  • the outer sheath tube 12 is pushed distally again, and the anchor member 22 is compressed and received in the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the outer sheath tube 12 is continued to be pushed distally until the lumen stent 200 is gradually compressed from the proximal end to the distal end and received in the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the lumen stent 200 is secured to the inner sheath core tube 13 by the anchoring unit 20, and the anchoring unit 20 limits the relative movement between the lumen stent 200 and the inner sheath core tube 13.
  • the position of the inner sheath tube 11 can be maintained unchanged, and the inner sheath tube 11 is driven to be opposite.
  • the outer sheath tube 12 is axially moved toward the proximal end to achieve the purpose of accommodating the anchor member 22 and the lumen holder 200 into the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the second housing 32 of the handle 30 is retracted proximally, and the outer sheath tube 12 is driven relative to the inner sheath core tube 13 Proximal axial movement.
  • the locking portion 222 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, the deformation portion 221 can also be restored to the natural unfolded state, at which time the anchor member 22 is automatically separated from the lumen holder 200, that is, The lumen stent 200 is no longer connected to the inner sheath core tube 13.
  • the lumen stent 200 is released from the outer sheath tube 12 and expands by itself and adheres to the vessel wall.
  • the entire tubular body 10 can be directly withdrawn, the position of the distal end of the tubular body 10 can be adjusted, and the lumen can be passed through the lumen with the aid of digital images.
  • the development mark on the stent 200 is observed until the distal end of the tube 10 is adjusted to a more desirable release position.
  • the withdrawal of the outer sheath 12 can be stopped and the entire tubular body 10 can be pulled proximally.
  • the portion of the lumen stent 200 that has been released may be subject to friction from other stents or implantable instruments that engage the inner wall of the vessel or cooperate with the lumen stent 200. This frictional force may result in a lumen stent.
  • the portion that has not been released 200 and the anchor 22 are subjected to a pulling force toward the distal end, so that the deformed portion 221 and the locking portion 222 that originally hooked the lumen stent 200 are also subjected to a pulling force toward the distal end and are generated along the inner sheath core tube 13. The tendency to expand radially outward.
  • the deformation portion 221 and the locking portion 222 and the inner sheath core tube 13 can maintain the engagement of the anchor.
  • the lumen stent 200 is always fixed to the inner sheath core tube 13 by the anchoring unit 20, and the operator withdrawing the tubular body 10 does not cause relative movement between the outer sheath tube 12 and the lumen stent 200, thereby avoiding The relative movement between the sheath 12 and the lumen stent 200 results in early release of the lumen stent 200.
  • the delivery system provided by the present invention is particularly suitable for delivering an implant that requires adjustment of the release position during release so that the released implant and other implants cooperate, for example, simultaneous opening of the aortic arch and left subclavian bone.
  • Arterial stenosis Place a chimney bracket or a top hat bracket in the left subclavian artery, or deliver a tracheal stent and an esophageal stent to adjust and recover the product release position.
  • the inner wall of the outer sheath tube 12 restricts the locking portion 222 and the deforming portion 221 from being deployed outward, and the lumen stent 200 is still fixed to the inner sheath core tube 13 by the anchoring unit 20.
  • the outer sheath tube 12 can be driven to move axially relative to the inner sheath core tube 13 so that the lumen stent 200 has been released.
  • the portion is recompressed and recovered into the cavity between the outer sheath tube 12 and the inner sheath core tube 13, and the tube body 10 is withdrawn from the patient's body to replace the appropriate lumen stent.
  • the use process of the delivery system 100 provided by this embodiment includes the following steps:
  • the first step percutaneous puncture into the guide wire to the lesion
  • the second step transporting the tube body 10 pre-installed with the lumen stent 200 along the guide wire to the lesion;
  • the third step driving the outer sheath tube 12 to move proximally.
  • the outer sheath tube 12 moves axially relative to the inner sheath core tube 13 and the lumen holder 200, and the lumen holder 200 is gradually released from the outer sheath tube 12.
  • it is evaluated whether the initial release position of the lumen stent 200 meets the clinical requirements by the development marker on the lumen stent 200.
  • the fourth step if the initial release position of the lumen stent 200 is ideal, the outer sheath tube 12 can continue to be moved axially relative to the inner sheath core tube 13 until the lumen stent 200 is completely intact from the outer sheath tube 12. freed.
  • Step 5 If the initial release position of the lumen stent 200 is not satisfactory, the outer sheath 12 can be stopped, the entire tubular body 10 can be withdrawn, and the position of the distal end of the tubular body 10 can be adjusted. In the process of adjusting the position of the distal end of the tubular body 10, since the lumen stent 200 is fixed to the inner sheath core tube 13 by the anchoring unit 20, between the lumen stent 200 and the outer sheath tube 12 and the inner sheath core tube 13 No relative movement occurs, effectively preventing the lumen stent 200 from being released early from the outer sheath tube 12.
  • the sixth step when the distal end of the tubular body 10 is adjusted to a more desirable release position, the outer sheath tube 12 is again driven to move axially proximally relative to the inner sheath core tube 13.
  • the anchor 22 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13
  • the deformed portion 221 and the locking portion 222 of the anchor 22 are restored to a naturally deployed state, and with the anchored lumen stent 200 automatic separation.
  • the lumen stent 200 is no longer connected to the inner sheath core tube 13.
  • the lumen stent 200 is completely released from the outer sheath tube 12, since the lumen stent 200 has superelasticity, the stent can be naturally inflated and attached to the lesion. Vascular wall.
  • Step 7 The handle 30 is withdrawn to drive the inner sheath core tube 13 to move proximally relative to the outer sheath tube 12. After the anchoring member 22 of the outer surface of the inner sheath core tube 13 is received in the outer sheath tube 12, the entire delivery system 100 is withdrawn and the tube body 10 is withdrawn from the patient.
  • the delivery system provided by this embodiment has at least the following beneficial effects:
  • the locking portion of the anchor member is bent through the end of the lumen bracket, and the deformed portion of the anchor member is bent toward the inner sheath core tube And is constrained between the inner sheath core tube and the outer sheath tube, even when passing through the relatively curved body lumen portion, the anchor member is not detached from the lumen bracket, thereby avoiding the prior art rigid protrusions and A gap is created between the inner walls of the outer sheath tube, resulting in the risk of the lumen support falling off from the rigid protrusion.
  • the delivery system of the present embodiment can effectively prevent the anchor body from being separated from the lumen stent when the tubular body passes through the curved blood vessel portion.
  • the lumen stent is fixed on the inner sheath core tube by the anchoring unit, and the lumen stent can be gradually released from the outer sheath tube, thereby avoiding the disadvantage that the release position cannot be adjusted after the lumen stent is suddenly released.
  • the operator can withdraw the tubular body and adjust the distal position of the tubular body.
  • the lumen stent is fixed on the inner sheath core tube. And the relative movement between the lumen stent and the outer sheath tube does not occur, effectively preventing the lumen stent from being released in advance from the outer sheath tube.
  • the proximal portion of the lumen stent is still fixed to the inner sheath core tube by the anchoring unit.
  • the body is withdrawn from the patient's body and the appropriate size of the lumen stent is replaced.
  • the deformation portion drives the locking portion to return to the natural state, and the anchor bracket and the inner sheath core tube no longer pass the anchor.
  • the lumen stent can be quickly released and expanded from the outer sheath.
  • the structure of the lumen stent delivery system provided in this embodiment is substantially the same as that of the lumen stent delivery system 100 provided in the first embodiment. The difference is that in the embodiment, the structure of the fastening member, the number and structure of the anchoring members are different from those of the first embodiment, the structure and the structure of the anchoring members.
  • the anchoring unit 40 includes a sleeve-like fastening member 41 having a certain wall thickness, and at least one anchoring member 42 connected to the fastening member 41.
  • the fastening member 41 has at least one pair of guide holes 411.
  • the guiding hole 411 includes a first hole 411a disposed on the distal end surface of the fastening member 41, and a second hole 411b disposed on the outer wall of the fastening member 41, and the first hole 41a and the second hole 41b communicate with each other.
  • a pair of guide holes 411 are formed.
  • the number of anchors 42 is three.
  • the number of the guide holes 411 is six pairs.
  • the guide hole 411 may be composed of at least one pair of guide holes communicating with each other between any two end faces or outer walls of the hoop member 41, such as but not limited to the distal end face of the hoop member 41.
  • the first hole is formed by the second hole of the proximal end face or by the first hole of the proximal end face of the tightening member 41 and the second hole of the outer wall.
  • each anchor 42 includes a U-shaped structure of twin strands.
  • Each U-shaped structure includes two straight rods and a circular rod connected between the two straight rods. Both ends of each U-shaped structure respectively pass through a pair of guide holes 411 of the hoop member 41. Therefore, the arcuate rod of the U-shaped structure is attached to the outer wall of the hoop member 41 as the fixing portion 423 of the anchor member 42.
  • the two straight rods of the U-shaped structure are respectively passed out through the pair of guide holes 411 from the distal end surface of the tightening hoop 41 as the deformed portion 421 of the anchor 42.
  • the locking portion 422 of the anchor 42 is a hollow tubular body that is sleeved at the distal end of the two straight rods of the U-shaped structure and binds the two straight rods together. Thereby, the locking portion 422 can restrict the U-shaped structure from coming off the self-tightening member 41. It can be understood that in other embodiments, the locking portion 422 can also be other shapes such as a spherical body. As long as the diameter of the locking portion 422 is greater than or equal to the diameter of the deformation portion 421, the deformation portion 421 and the locking portion 422 can be received. When the external force acts, the elastic deformation amount of the locking portion 422 is smaller than the elastic deformation amount of the deformation portion 421.
  • the U-shaped structure of the anchor 42 is a wire, a wire, a pillar, a strip, a ribbon or a sheet which can be bent.
  • the U-shaped structure can be made of a flexible material such as a polymer material.
  • the U-shaped structure can also be made of a material having elasticity, such as an alloy material.
  • each U-shaped structure is woven from nickel-titanium wire.
  • the anchor may have other shapes such as an L-shape, an S-shape, or a V-shape, as long as the deformation portion of the anchor can be bent and passed through the guide hole.
  • the deforming portion 421 is bent in the direction of the inner sheath core tube. 421.
  • the locking portion 422 and the inner sheath core tube form an anchor.
  • the inner wall restricting deformation portion 421 and the locking portion 422 of the outer sheath tube are radially outwardly expanded along the inner sheath core tube.
  • the length L2 of the locking portion 422 along the axial direction of the inner sheath core tube is larger than the gap w between the inner sheath core tube and the outer sheath tube. Therefore, when the locking portion 422 is only partially housed in the cavity between the outer sheath tube and the inner sheath core tube, the locking portion 422 does not spread away from the inner sheath core tube, and the deformation portion 421 and the lock can be retained.
  • the portion 422 is mated with the inner sheath core tube to form an anchor.
  • the length L2 of the locking portion 422 along the axial direction of the inner sheath core tube is preferably greater than 0.1 mm and less than 15 mm to ensure the stability of the locking portion 422 in the anchor state, while the deformation portion 421 and the locking portion 422 are from the outer sheath.
  • the locking portions 422 do not contact each other, and the mutual interference between the plurality of anchors 22 is prevented to affect the anchor 42 and the lumen bracket. Smooth separation.
  • the diameter of the locking portion 422 is smaller than the gap w between the inner sheath core tube and the outer sheath tube, so that the locking portion 422 can be received in the cavity between the inner sheath core tube and the outer sheath tube.
  • the loading process of the lumen support 200 is as follows: Referring to FIG. 8a, the deformation portion 421 and the locking portion 422 of the anchor 42 are first passed through the lumen support 200. The metal skeleton at the proximal trough, and then the locking portion 222 is pressed in the direction of the inner sheath core tube, so that the deformation portion 421 is bent toward the proximal end, at which time the locking portion 222, the deformation portion 221 and the inner sheath core tube cooperate to form an anchor. The hook holder 200 is hooked.
  • the inner sheath tube is then driven to move axially relative to the outer sheath tube, and the locking portion 422 and the deforming portion 421 of the anchor 42 are received into the cavity between the outer sheath tube and the inner sheath core tube.
  • the inner sheath is continuously withdrawn until the lumen stent is gradually compressed and received into the cavity between the outer sheath and the inner sheath core.
  • the delivery system provided in this embodiment has at least the following beneficial effects:
  • the deformation portion of the anchor has a U-shaped structure
  • the tubular locking portion is sleeved at the distal end of the U-shaped structure and the two straight rods of the U-shaped structure are tied together to avoid anchoring.
  • the piece is detached from the self-tightening member to improve the reliability of the connection between the lumen support and the anchoring unit.
  • the fastening member 41 can be provided with only a pair of guiding holes 411, and only one anchoring member 42 is fixedly connected with the fastening member guiding holes.
  • the structure of the lumen stent delivery system provided in this embodiment is substantially the same as that of the lumen stent delivery system 100 provided in the first embodiment. The difference is that in the embodiment, the structure of the inner sheath core tube and the tightening member, the number and structure of the anchoring member, the structure of the inner sheath core tube and the tightening member, the number of anchoring members, and The structure is different.
  • the anchoring unit 50 includes a sleeve-like fastening member 51 and five anchoring members 52 connected to the fastening member 51.
  • the anchor 52 includes a deforming portion 521 connected to the tightening member 51 and a spherical locking portion 522 connected to the deforming portion 521.
  • the anchoring unit 50 is laser engraved from a nickel-titanium tube having a tube wall thickness ranging from 0.05 mm to 2 mm.
  • a deformation portion 521 (as shown in FIG. 9b), and one end of the deformation portion 521 is welded into a spherical locking portion 522 by a laser spot welding process (as shown in the figure). 9a)).
  • the inner diameter of the inner sheath tube 61 near the distal end is larger than the inner diameter of the inner sheath tube 61 near the proximal end.
  • the tightening member 51 of the anchoring unit 50 can be embedded in the proximal end of the inner sheath tube 61 and the inner sheath core tube along the direction indicated by the arrow in FIG. 11 (not shown) Out).
  • the fastening member 51 is fixed to the inner sheath tube 61 and the inner sheath core tube by means of techniques commonly used in the art, such as dispensing. .
  • the outer surface of the inner sheath tube 61 is provided with a receiving groove 611 for accommodating the deforming portion 521 and a receiving hole 612 for accommodating the locking portion 522. Therefore, after the deformation portion 521 and the lock portion 522 are bent with respect to the inner sheath tube 61, and the deformation portion 521 is housed in the accommodation groove 611 of the outer surface of the inner sheath tube 61, the lock portion 522 is housed in the inner sheath tube 61. In the receiving hole 612 of the outer surface, the locking portion 522 is further restricted from moving, and the reliability of the connection between the lumen bracket 200 and the anchor 52 is improved.
  • the length of the locking portion 522 in the radial direction should be larger than the gap between the inner sheath tube 61 and the receiving groove 611 and the outer sheath tube to prevent the locking portion 522 from accidentally coming out.
  • the anchoring unit 50 can be disposed on the outer surface of the outer tube of the inner sheath core tube, so that the proximal end surface of the tightening member 51 does not abut the inner sheath tube 61. Remote end face.
  • a receiving groove for accommodating the deforming portion 521 and a receiving hole for accommodating the locking portion 522 may be provided on the outer surface of the tightening member 51.
  • the number of anchors may be only one.
  • the length of the deformation portion of the anchor member in the natural state ie, when not received in the outer sheath tube
  • the deformation portion and the locking portion sequentially pass through the metal skeleton at the trough of the proximal end of the lumen bracket, the deformation portion is bent, and the locking portion is attached to the outer wall of the inner sheath core tube, and the outer sheath tube restricts the locking.
  • the movement of the part reaches the purpose of fixing the lumen bracket.
  • the deformation portion and the locking portion are preferably metal skeletons at two valleys symmetrically disposed through the proximal end of the lumen stent. It can be understood that the deformation portion and the locking portion may also pass through only the skeleton at one trough or a skeleton at a larger number of troughs.
  • the outer wall of the inner sheath core tube is preferably provided with a receiving groove for receiving the locking portion of the anchor, and the receiving groove is preferably disposed adjacent the opposite side of the anchor .
  • the deformation portion and the locking portion are housed in the accommodating space of the outer surface of the inner sheath core tube, and the accommodating space cooperates with the inner wall of the outer sheath tube to further restrict movement of the locking portion and the deformation portion, thereby improving the lumen bracket and the anchoring member The reliability of the connection between.
  • Embodiment 4
  • the structure of the implant 800 delivery system provided by this embodiment is substantially the same as that of the lumen support delivery system 100 provided in the third embodiment.
  • the conveyor does not have an inner sheath tube and a tight band member, and the number of the anchor members and the connection structure with the inner sheath core tube are different from those of the third embodiment.
  • the anchoring unit 70 includes four anchoring members 71 connected to the inner sheath core tube 13.
  • the anchor 71 includes a deformed portion 711 connected to the inner sheath core tube 13 and a locking portion 712 connected to the deformed portion 711.
  • the deformation portion 711 is connected to the inner sheath core tube 13 by laser welding (not limited thereto).
  • the gap between the inner sheath core tube 13 and the outer sheath tube 12 forms a receiving space for receiving the anchoring member 71, and the deforming portion 711 and the locking portion 712 are opposite to the inner sheath core tube 13. After being bent, it is accommodated between the inner sheath core tube 13 and the outer sheath tube 12.
  • the axial length L1 of the anchor locking portion 712 along the inner sheath core tube should be greater than the inner sheath core tube 13 and the outer sheath.
  • the gap w of the tube 12 is such that the anchor 71 can be smoothly unlocked after the outer sheath 12 is withdrawn, and the axial length L1 of the anchor locking portion 712 along the inner sheath core tube should preferably be greater than 0.1 mm and less than 15 mm.
  • the number of anchoring units may be only one, or may be distributed on the inner sheath core tube.
  • the embodiment further simplifies the conveying system, reduces the necessary parts under the premise of ensuring that the anchoring unit is not loosened in advance, and reduces the difficulty in production and assembly.
  • the structure of the implant delivery system provided by this embodiment is basically the same as that of the lumen support delivery system provided in the first embodiment.
  • the anchor locking portion is a polymer ball. It can be understood that in other embodiments, other materials having a certain hardness such as metal may be used, and one end of the deformed portion is formed by injection molding or the like. The phase is fixed, and the other end of the deformation portion is fixed to the fastening member.
  • the locking portion is received by the proximal end surface of the fastening member after the deformation portion is bent and deformed.
  • the deformation portion receives an external force, the locking portion is not restrained by the tightening member.
  • the gap W between the hoop member and the outer sheath tube should be smaller than the warp length W1 of the lock portion.
  • the locking portion may be other shapes that are irregular, but the radial dimension in the receiving state should be greater than the gap between the tightening member and the outer sheath tube.
  • the number of anchoring units may be only one, or may be distributed on the inner sheath core tube.
  • Embodiments 1 to 5 illustrate the specific embodiment of the present invention by taking the delivery system of the lumen stent as an example. It can be understood that the delivery system of the present invention is used for conveying other implants. And the locking portion can pass through the skeleton, through hole, recovery hook, loop or other hollowed portion of the proximal or distal end of the implant. For example, when used to transport a temporary filter, the deformation portion and the locking portion may be connected to the filter through a recovery hook at the proximal end of the filter. When used to deliver a cardiac occluder, it can be connected to the heart occluder through the proximal end of the heart occluder.
  • the delivery system provided by the invention is suitable for transporting a blood vessel stent, for example, for simultaneously opening aortic arch stenosis and left subclavian artery stenosis, placing a chimney bracket or a top hat bracket in the left subclavian artery, or conveying a tracheal stent and an esophageal stent to realize a product release position. Adjustment and recycling.

Abstract

植入物(200)的输送系统(100)，包括内鞘芯管(13)和可动地套设于内鞘芯管(13)外部具有空腔的外鞘管(12)，以及固定于内鞘芯管(13)的外表面的至少一个锚定单元(20)；锚定单元(20)包括套设于内鞘芯管(13)的外表面的紧箍件(21)及至少一个与紧箍件(21)相连的锚定件(22)，锚定件(22)包括可相对内鞘芯管(13)弯折的变形部(221)及与变形部(221)相连的锁定部(222)，变形部(221)与锁定部(222)在收容于外鞘管(12)与内鞘芯管(13)之间的空腔内时，与紧箍件(21)配合形成锚状物。锚定单元(20)将植入物(200)固定在内鞘芯管(13)上，限制植入物(200)的移动。由此，在植入物(200)的输送过程中，植入物(200)与内鞘芯管(13)不发生偏移。并且在释放过程中，当需要调整植入物(200)的释放位置时，能避免植入物(200)提前释放。

Description

植入物的输送系统 技术领域
本发明涉及植入式医疗器械，具体涉及植入物的输送系统。
背景技术
对于血管狭窄、动脉瘤和血管夹层等疾病，管腔支架介入手术具有创伤小、恢复快、并发症少、治疗效果好等优势。
自膨式支架管腔支架的金属骨架结构通常由镍钛合金制成，经过热定型工艺后，使得管腔支架具有恢复自身形状的能力。目前这类支架的输送系统的管体一般包含一根外鞘管，和一根预装于外鞘管内的内鞘芯管。内鞘芯管的近端较粗，远端较细，管腔支架收容于外鞘管与内鞘芯管远端部分之间的空腔中，且支架的远端与内鞘芯管较粗部分的远端端面紧贴，内鞘芯管用于连接导引头(或称Tip头)和容纳并通过导丝。当输送系统到达病变部位，向近端回撤外鞘管，使得外鞘管与管腔支架相对运动，将管腔支架自外鞘管内释放，管腔支架依靠自身的回弹性展开并贴附血管内壁。这种输送系统中管腔支架与鞘芯管之间仅通过摩擦力相连，当内鞘芯管与外鞘管通过人体血管的弯曲部位会适应血管形态而弯曲，管腔支架也容易发生移位，会影响后续释放，且在后撤外鞘管时，支架也会容易移位，导致释放位置不理想，进而影响治疗效果。
通过在内鞘芯管上设置刚性凸起物穿过管腔支架的镂空，可在内鞘芯管与外鞘管之间的空腔内限制管腔支架相对内鞘芯管移动。然而这种输送系统仍然存在如下缺陷：(1)在管腔支架的输送过程中，当外鞘管与鞘芯管共同通过人体管腔的弯曲部位时，在弯曲血管的弯曲半径较小的一侧，鞘芯管与外鞘管之间的间隙减小；在弯曲血管的弯曲半径较大的一侧，鞘芯管与外鞘管之间的间隙增大，此时刚性凸起物与外鞘管的内壁之间的距离增大，刚性凸起物与管腔支架较易分离，管腔支架可能脱离凸起物的约束，进而导致管腔支架在外鞘管中的位置发生偏移，影响后续释放。(2)当鞘芯管与外鞘管到达病变部位后，操作者后撤外鞘管释放管腔支架时，管腔支架可能快速自外鞘管中完全释放，如遇释放位置不理想，无法调整释放位置。(3)当管腔支架自外鞘管之中部分释放后，如发现管腔支架的释放位置不理想，需要调整外鞘管的远端位置，而管腔支架在调整过程中可能自外鞘管之中提前完全释放。
发明内容
基于此，有必要提供一种植入物的输送系统，即使在弯曲的血管内，该输送系统仍可以将植入物可靠地固定在鞘芯管上。避免植入物与内鞘芯管之间发生偏移。并且，可在释放过程中逐渐释放植入物，避免了植入物突然释放后无法调整释放位置的缺点，以及在调整释放植入物的释放位置的 过程中，避免植入物提前完全释放。
本发明提供的植入物的输送系统，包括内鞘芯管，和可动地套设于所述内鞘芯管外部具有空腔的外鞘管。所述输送系统还包括固定于所述内鞘芯管的外表面的至少一个锚定单元。所述锚定单元包括套设于所述内鞘芯管的外表面的紧箍件及至少一个与所述紧箍件相连的锚定件。所述锚定件包括可相对所述内鞘芯管弯折的变形部及与所述变形部相连的锁定部。所述变形部与所述锁定部在收容于所述外鞘管与所述内鞘芯管之间的空腔内时，与所述紧箍件配合形成锚状物。由此，当所述锚定件收容于所述外鞘管与所述内鞘芯管之间的空腔时，所述锚定件可以钩住所述植入物，并限制所述植入物与所述内鞘芯管之间的相对移动。当所述外鞘管相对于所述内鞘芯管向近端轴向运动，所述锚定件自所述外鞘管与所述内鞘芯管之间的空腔中释放，所述变形部沿所述内鞘芯管的径向向外展开，所述植入物与所述锚定件分离，之后所述植入物自所述外鞘管中释放。
在其中一个实施例中，在所述变形部与所述锁定部受到同等外力作用时，所述锁定部的弹性形变量小于所述变形部的弹性形变量。
在其中一个实施例中，制成所述锁定部的材料的弹性模量小于或者等于制成所述变形部的材料的弹性模量。
在其中一个实施例中，所述锁定部的直径大于或者等于所述变形部的直径。
在其中一个实施例中，所述锁定部为套设于所述变形部的远端部的中空的管状体或者球状体。
在其中一个实施例中，在所述锁定部收容于所述外鞘管中时，所述锁定部沿所述内鞘芯管的轴向的长度大于所述紧箍件与所述外鞘管之间的间隙。
在其中一个实施例中，在所述内鞘芯管收容于所述外鞘管中时，所述锁定部的长度大于0.1mm，小于15mm。
在其中一个实施例中，所述锚定件还包括连接于所述紧箍件及所述变形部之间的固定部。在其中一个实施例中，所述锚定单元包括1至12个锚定件。
在其中一个实施例中，所述1至12个锚定件围绕所述内鞘芯管的中心轴呈对称或者不对称设置。
在其中一个实施例中，所述紧箍件的外表面或者所述内鞘管的外表面设有用于容纳所述锁定部及所述变形部的收容空间。
在其中一个实施例中，所述紧箍件的任意两个端面或外壁之间具有至少一对彼此相通的导孔，所述锚定件具有双股线构成的U型结构，所述U型结构的两端分别贯穿一对所述导孔。
在其中一个实施例中，所述内鞘管的靠近远端的管体内径大于所述内鞘管的靠近近端的管体内径，所述锚定单元的紧箍件嵌入所述内鞘管的靠近远端的管体及所述内鞘芯管之间。
在其中一个实施例中，在所述锁定部收容于所述外鞘管中时，所述锁定部沿所述内鞘芯管的轴 向的长度大于所述内鞘芯管与所述外鞘管之间的间隙。
本发明提供的植入物的输送系统，包括内鞘芯管，和可动地套设于所述内鞘芯管外部具有空腔的外鞘管；所述输送系统还包括固定于所述内鞘芯管的外表面的至少一个锚定单元，所述锚定单元包括至少一个与所述内鞘芯管相连的锚定件，所述锚定件包括可相对所述内鞘芯管弯折的变形部及与所述变形部相连的锁定部，所述变形部与所述锁定部在收容于所述外鞘管与所述内鞘芯管之间的空腔内时，与所述内鞘芯管配合形成锚状物。
在其中一个实施例中，所述锁定部收容于所述外鞘管中时，所述锁定部沿所述内鞘芯管的轴向的长度大于所述内鞘芯管与所述外鞘管之间的间隙。本发明的输送系统在内鞘芯管上设置锚定件替代刚性凸起物来约束管腔支架，至少具有以下有益效果：
(1)当装载有植入物的管体在人体管腔内输送时，锚定件的锁定部穿过植入物端部的镂空后，锚定件的变形部朝内鞘芯管弯折并被约束在内鞘芯管和外鞘管之间，即使通过较弯曲的人体管腔部位时，锚定件也不会与植入物脱离，避免了现有技术的刚性凸起物会与外鞘管内壁之间产生缝隙，导致植入物自刚性凸起物脱落的风险。
(2)在装载有植入物的管体被输送至弯曲的人体血管，在弯曲血管的弯曲半径较大的一侧，内鞘芯管与外鞘管之间的间隙增大，此时如果整个管体受到弯曲的血管内壁的挤压作用或者由于操作者的推送导致管体轻度弯折，锚定件受到外力作用，变形部就会发生弹性形变，并带动锁定部沿着内鞘芯管的径向向外展开。由于变形部与锁定部在受到同等外力作用时，锁定部的弹性形变量小于变形部的弹性形变量。因此，当较难发生弹性形变的锁定部的头端接触外鞘管内壁时，锁定部会停止向外展开并限制变形部继续向外展开。此时，整个锚定件达到稳定状态，管腔支架仍然通过锚定件被固定在内鞘芯管上。因此，本发明的输送系统可以有效地避免管体在经过弯曲的血管部位时，锚定件与管腔支架发生分离。
(3)在锁定部的长度范围内可以在外鞘管的约束下逐渐释放植入物，直至露出全部锚定件，避免了植入物突然释放后无法调整释放位置的缺点。
(4)当手术过程中需要调整植入物的释放位置时，操作者可以后撤管体并调整管体远端位置，在调整过程中，植入物被固定于内鞘芯管之上，且植入物与外鞘管之间不会发生相对运动，有效防止植入物自外鞘管之中提前释放。
(5)在手术过程中，当植入物被部分释放，如发现植入物的尺寸与病变部位不符合，由于植入物靠近近端的部分仍然通过锚定单元固定于内鞘芯管之上，可以通过驱动外鞘管相对于内鞘芯管向远端轴向运动，将已经释放的植入物重新回收至外鞘管与内鞘芯管之间的空腔之中，再将管体撤出病人体外，更换尺寸适宜的植入物。
(6)当锚定单元的锁定部自外鞘管与内鞘芯管之间的空隙中释放，快速带动较易变形的变形 部恢复自然状态，植入物与内鞘芯管之间不再通过锚定件连接，植入物可自外鞘管中快速释放并膨胀。
附图及附图说明
图1a至图1c为实施例一提供的管腔支架输送系统的主视图，输送系统包括手柄、管体及锚定单元，管体包括外鞘管、内鞘芯管及内鞘管，其中，图1a为锚定单元、内鞘芯管及内鞘管收容于外鞘管中的示意图，图1b为锚定单元、内鞘芯管及内鞘管未收容于外鞘管中的示意图，图1c为图1b中A处的局部放大图；
图2a及图2b为图1b中的锚定单元的结构示意图，锚定单元包括四个锚定件及一个紧箍件，其中，图2a为锚定单元未收容于外鞘管中的示意图，图2b为锚定单元收容于外鞘管中的示意图；
图3a及图3b为图1c中的锚定单元、管体在平行于管体的轴向上的截面上的部分剖视图，其中，图3a为锚定件收容于管体中，变形部及锁定部钩住管腔支架的示意图，图3b为变形部及锁定部沿着内鞘芯管的径向向外展开的示意图；
图4a为锚定单元的另一种实施方式的结构示意图；
图4b为锚定单元的另一种实施方式的结构示意图；
图5为管体的另一种实施方式的结构示意图；
图6a至图6d为第二实施例提供的输送系统中，锚定单元的结构示意图，锚定单元包括紧箍件及锚定件，其中，图6a为锚定单元的主视图，图6b为紧箍件的主视图，图6c为锚定件与紧箍件的结合方式的示意图，图6d为锚定单元收容于外鞘管中的示意图；
图7为图6d中的锚定单元收容于外鞘管中时，锚定单元在平行于管体轴向的截面上的局部剖视图；图8a及图8b为管腔支架装载至第二实施例的外鞘管中的过程示意图，其中，图8a为管腔支架与部分锚定件连接的示意图，图8b为管腔支架与全部锚定件连接并逐渐收容至外鞘管之中的示意图；
图9a及图9b为第三实施例提供的输送系统中，锚定单元的示意图，其中，图9a为锚定单元主视图；图9b为锚定单元的制作过程中的中间产物的主视图；
图10为第三实施例提供的输送系统中，锚定单元及内鞘管的远端段在平行于内鞘管轴向的截面上的剖视图；
图11为图9a中的锚定单元嵌入内鞘管的远端段的过程示意图；
图12a及图12b为第三实施例提供的输送系统中，锚定单元及内鞘管远端段的示意图，内鞘管远端段具有收容槽及收容孔，其中，图12a为变形部及锁定部未收容于收容槽及收容孔中的示意图，图12b为部分变形部及锁定部分别收容于收容槽及收容孔中的示意图；
图13a为第三实施例提供的锚定件仅为一个的示意图；
图13b及图13c为图13a提供的锚定单元在变形部完全变形后的主视图及内鞘芯管的远端段在平行于内鞘芯管轴向的截面上的剖视图；
图14a、图14b及图14c为实施例四所提供的输送系统中，锚定单元及内鞘芯管远端段的示意图；
图14d为内鞘芯管的远端段在平行于内鞘芯管轴向的截面上的剖视图；
图15为实施例五提供的输送系统中，锚定单元及内鞘芯管远端段的示意图在平行于内鞘芯管轴向的截面上的剖视图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
需要说明的是，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。在介入领域，通常将相对操作者近的一端称为近端，相对操作者远的一端称为远端。
为了更加清楚地描述输送系统及植入物的结构，此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，在介入医疗领域，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。除非另有定义，本发明所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本发明在说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
实施例一
请同时参见图1a至图1c，实施例一提供的输送系统100，用于将植入物输送至人体管腔内的病变部位。输送系统100包括管体10、锚定单元20、以及手柄30。本实施例中，植入物为管腔支架200。
手柄30包括对称设置的第一壳体31和第二壳体32。第一壳体31与第二壳体32之间可沿轴向相对运动，且第一壳体31较第二壳体32更接近远端。
管体10包括轴向贯穿手柄30的中空的内鞘管11、贯穿内鞘管11且远端伸出内鞘管11的中空的内鞘芯管13、可动地套设于内鞘管11外部并与内鞘芯管13之间具有空腔的外鞘管12、及设置于内鞘芯管13的远端且不透X射线的中空的Tip头14。压缩后的管腔支架200装载于内鞘芯管13的远端与外鞘管12的远端之间的空腔中，并与内鞘芯管13的外表面摩擦接触。内鞘管11与第一壳体31相连。外鞘管12与第二壳体32相连。由此，操作者可以通过操作手柄30的第二壳体32与第一壳体31之间的相对运动来驱动外鞘管12相对内鞘芯管13在轴向上运动，向近端后撤外鞘管12，最终使得管腔支架200 自外鞘管12之中释放。在其他实施例中，手柄可为其他结构，例如，手柄上可以设置与外鞘管12垂直相连的滑块，操作者可以通过拖拽滑块来驱动外鞘管12的轴向运动。
内鞘管11轴向贯穿手柄30的近端端面与远端端面。内鞘管11与位于内鞘管11内部的内鞘芯管13固定连接。固定连接的方式可以是焊接、粘合、缝合、热熔或者螺纹连接等本领域常用的技术手段，在此不再详述。本实施例中，内鞘管11由具有韧性的高分子材料制成。可以理解的是，在其他实施例中，内鞘管11也可以由金属材料制成。还可以理解的是，在其他实施例中，内鞘管11也可以为高分子材料制成的管体与金属材料制成的管体的组合。例如，内鞘管11靠近远端的管体部分收容于外鞘管12之中，由具有韧性的高分子材料制成，以利于提高内鞘管11在弯曲的人体管腔中的可通过性；内鞘管11靠近近端的管体部分位于手柄30内部，由金属材料制成，以提高内鞘管11近端的支撑性。
外鞘管12套设于内鞘管11及内鞘芯管13的外部，并可在手柄30的驱动下相对内鞘管11及内鞘芯管13在轴向运动。当驱动外鞘管12向远端前进，可以实现管腔支架200收容至外鞘管12之中；当驱动外鞘管12向近端后撤，可以实现管腔支架200自外鞘管12之中释放。外鞘管12由具有韧性的高分子材料或者金属材料制成。可以理解的是，在其他实施例中，可以在外鞘管12靠近近端的管体外面套设硬度较高的加强管(图未示出)，或者将硬度较高的加强管与外鞘管12的近端轴向相连。由此可以提高外鞘管12在手柄30中的可通过性。
内鞘芯管13靠近近端的管体收容于内鞘管11之中。内鞘芯管13收容于内鞘管11之中的管体与内鞘管11通过焊接、粘合、缝合、热熔或者螺纹连接等本领域通用的连接方式固定在一起，以提高内鞘芯管13的支撑性。另外，当外鞘管12相对于内鞘管11及内鞘芯管13进行轴向运动时，内鞘管11的外壁与外鞘管12的内壁之间发生摩擦，固定在一起的内鞘芯管13与内鞘管11之间不易发生相对偏离或者弯折。内鞘芯管13的远端穿出内鞘管11的远端，即内鞘芯管13靠近远端的管体未被内鞘管11包裹。压缩后的管腔支架200装载于内鞘芯管13未被内鞘管11包裹的管体与外鞘管12之间形成的空腔中。内鞘芯管13的远端连接不透射线的中空的Tip头14，连接方式可以是注塑成型或者粘合等方式。内鞘芯管13的内腔与Tip头14的内腔相通。内鞘芯管13和Tip头14的内腔用于容纳并通过导丝(图未示出)。
可以理解的是，在其他实施例中，输送器可不包含内鞘管11。
请一并参见图2a，锚定单元20设于内鞘芯管13未被内鞘管11包裹的管体的外表面。锚定单元20包括套设于内鞘芯管13的外表面的紧箍件21及至少一个与紧箍件21相连的锚定件22。本实施例中，锚定件22的数量为四个。四个锚定件22围绕内鞘芯管13的中心轴呈对称设置。可以理解的是，在其他实施例中，锚定件22也可以围绕内鞘芯管13的中心轴不对称设置。
每个锚定件22均包括与紧箍件21相连并可相对紧箍件21弯折的变形部221、及与变形部相连的锁定部222。由于外鞘管12可以相对于内鞘芯管13轴向运动，因此锚定件22的变形部221及锁定部222 可活动地收容于外鞘管12与内鞘芯管13之间形成的空腔之中(如图2b所示)。
请参见图3a，当锚定件22收容于外鞘管12与内鞘芯管13之间形成的空腔中，变形部221向靠近近端的方向弯折，变形部221与锁定部222指向近端，并与内鞘芯管13配合形成锚状物。多个锚状物钩住管腔支架200的靠近近端的镂空处(即，波谷处骨架)，将管腔支架200固定在内鞘芯管13上。
请参见图3b，当外鞘管12相对于内鞘芯管13向近端轴向运动，锚定件22逐渐自外鞘管12与内鞘芯管13之间的空腔中释放，变形部221与锁定部222沿内鞘芯管13的径向向外展开，恢复至自然展开状态，并与管腔支架200分离。管腔支架200在解脱与锚定件22的固定后，最终自外鞘管12中完全释放并展开贴覆血管壁。
变形部221由具有柔性的材料(例如聚四氟乙烯等高分子材料)、具有一定硬度的金属材料(例如不锈钢等金属材料，或者聚醚嵌段酰胺等高分子材料)，或者具有弹性的材料(例如镍钛合金等合金材料)制成。因此当受到外力作用时，变形部221可发生一定程度的变形。
制成锁定部222的材料的硬度大于制成变形部221的材料的硬度，由此，在变形部221与锁定部222受到同等外力作用时，锁定部222的形变量小于变形部221的形变量。这种形变量的差异使得在管腔支架200的输送过程中，当变形部221受到外力作用发生变形时，锁定部222不会发生变形，因此在锁定部222接触外鞘管12的内壁后就会停止沿着内鞘芯管13的径向向外展开，可以继续保持锚定件22与管腔支架200之间的连接，避免连接失效。本实施例中，变形部221由具有形状记忆功能的镍钛合金制成。锁定部222由不锈钢制成。
请再次参见图3a，在锁定部222收容于外鞘管12中时，锁定部222沿内鞘芯管13的轴向的长度L1大于内鞘芯管13与外鞘管12之间的间隙w。这样设置的目的是，当变形部221弯折后，与锁定部222及内鞘芯管13配合形成锚状物钩住管腔支架200的骨架。如果管腔支架200与锚定件22之间需要解脱连接，则需要锁定部222向外展开恢复至自然状态。而锁定部222向外展开需要一定的空间，该空间至少应当等于锁定部222的长度L1，因此本发明中，设置锁定部222的长度L1大于内鞘芯管13与外鞘管12间的间隙w，使得锁定部222在收容于外鞘管13中时无法向外展开，保证了锚定件22与管腔支架200之间的连接更为可靠。
在锚定件22收容于外鞘管12中时，锁定部222沿内鞘芯管13的轴向的长度L1为5mm。。当装载有管腔支架200的管体10到达病变部位，在释放管腔支架200的过程中，变形部221及锁定部222也需要自外鞘管12与内鞘芯管13之间的空腔中释放，因此这样设置可以避免锁定部222自外鞘管12中释放后刮伤血管。此外，如果锚定单元20包括两个或者更多数量的锚定件22，锁定部222的长度L1小于释放位置血管内径的二分之一也可以避免多个锚定件22之间相互干涉，影响锚定件22与管腔支架200的分离。
可以理解的是，在其他实施例中，所述锁定部222的长度L1的设计可根据释放血管的内径的不 同而不同，优选的，锁定部222的长度L1应大于0.1mm，小于15mm，以兼顾锁定部222在锁定状态下不易因不可控的变形导致意外脱出失效，同时避免锁定部222过长在解锁时对血管内壁的损伤。
优选地，锁定部222的直径大于或者等于变形部221的直径。例如，锁定部222与变形部221可以为直径相同的单根丝状，二者通过激光焊接、粘合等本领域常用的手段连接在一起，也可以为一个整体，如同一根或同一股金属丝(不限于)，通过不同的热处理工艺，使锁定部222与变形部221体现出不同的力学性能。锁定部222也可以是套设在变形部221的远端端部的管状体或者球状体，以进一步保证在变形部221与锁定部222受到相同的外力作用时，变形部221的弹性形变量大于锁定部222的弹性形变量。
可以理解的是，在其他实施例中，每个锚定单元可以仅包括1个锚定件。还可以理解的是，在其他实施例中，每个锚定单元也可以包括更多数量的锚定件，以增加锚定单元与管腔支架连接的牢固可靠性。但是，为了保证管体的直径可以顺利通过弯曲的人体管腔，锚定件的数量应当小于或者等于12个。
请再次参见图1c及图2a，紧箍件21套设于内鞘芯管13的外表面，并与内鞘芯管13的外表面通过粘合、过盈配合、缝合、热熔或者焊接(例如，激光点焊)等方式固定连接。本实施例中，紧箍件21通过粘合固定于内鞘芯管13的外表面之上。紧箍件21为具有一定壁厚的套管。紧箍件21的内径大于或者等于内鞘芯管13的外径。紧箍件21的外径小于外鞘管12的内径。紧箍件21可以由高分子材料或者金属材料制成。
可以理解的是，在其他实施例中，锚定件22还可以包括连接于紧箍件21及变形部221之间的固定部223(如图4a所示)。紧箍件21的管壁上沿轴向具有通孔。紧箍件21沿内鞘芯管13的轴向的长度小于固定部223沿内鞘芯管13的轴向的长度。由此，锚定件22的固定部223轴向贯穿通孔212后，将固定部223远离变形部221的一端通过激光点焊形成球体，且球体直径大于通孔直径，以保证固定部223不会自紧箍件21中脱落。
固定部223及变形部221可以由相同的材料制成，也可以由不同的材料制成，只要变形部221由具有弹性的材料制成，即可达到与管腔支架200可拆卸连接的目的。优选地，为了保证锚定件22与紧箍件21之间的连接可靠性，固定部223应当由具有一定硬度的材料制成。
还可以理解的是，在其他实施例中，紧箍件21与锚定件22的固定部223还可以具有其他连接方式。例如，紧箍件21的管壁上沿轴向具有盲孔。紧箍件21沿内鞘芯管13的轴向的长度大于固定部223沿内鞘芯管13的轴向的长度。由此，锚定件22的固定部223穿设于盲孔之中，并与紧箍件21通过热熔、焊接、粘合或者螺纹连接等方式固定在一起。
还可以理解的是，在其他实施例中，为了减小锚定单元20的尺寸，紧箍件21可以为壁厚较薄的片状。锚定件22的固定部223位于紧箍件21的内壁并与紧箍件21通过热熔、焊接、粘合或者螺纹连 接等方式固定在一起(如图4b所示)。即，固定部223位于紧箍件21与内鞘芯管13的外表面之间。由紧箍件21限制固定部223与内鞘芯管13的外表面之间的相对移动，以此达到将锚定单元20固定在内鞘芯管13上的目的。
还可以理解的是，在其他实施例中，紧箍件21还可以是由热收缩性材料制成的中空套管。锚定件22的固定部223设于紧箍件21与内鞘芯管13的外表面之间。通过将紧箍件21加热至热收缩性材料的热收缩温度，使得紧箍件21受热收缩并牢牢包裹内鞘芯管13，从而限制锚定件22的固定部223与内鞘芯管13的外表面之间发生相对移动。
可以理解的是，在其他实施例中，管体10可以不包括内鞘管11。具体地，请参见图5，管体10包括轴向贯穿手柄30(见图1a)的中空的内鞘芯管13、可活动地套设于内鞘芯管13外部的外鞘管12、及设置于内鞘芯管13的远端且不透X射线的中空的Tip头14。内鞘芯管13包括靠近近端的第一管体131及与第一管体131的远端轴向相连的第二管体132，且第一管体131的直径大于第二管体132的直径。由此，压缩后的管腔支架200可收容于外鞘管12与第二管体132之间的空腔中，并与第二管体132摩擦接触。锚定单元20设于第二管体132上，并与管腔支架200(见图1b)可拆卸连接。可以理解的是，第一管体131及第二管体132可以由不同的材料制成。例如，第一管体131由具有韧性的高分子材料制成，第二管体132由金属材料制成，以保证内鞘芯管13的远端柔顺性及近端支撑性。还可以理解的是，在其他实施例中，第一管体131及第二管体132也可以由相同的材料制成。例如，第一管体131及第二管体132均由具有韧性的高分子材料制成。还可以理解的是，在其他实施例中，内鞘芯管13还可以包括第三管体(图未示出)。第三管体可以套设于第一管体131靠近近端的管体部分上。第三管体也可以与第一管体131的近端轴向相连。第三管体的硬度高于第一管体131的硬度，以起到加强挺直的作用，提高内鞘芯管13的近端支撑性。
可以理解的是，在其他实施例中，输送系统100还可以包括固定安装于手柄30上的三通阀及软管，以用于传输冲洗液或者造影剂。由此，在手术前，操作者可通过三通阀及软管以导入冲洗液而冲洗内鞘管的外部、或者排出外鞘管与内鞘管之间的空气。也可在术前或者术中，通过三通阀及软管注射造影剂进行数字造影。
管腔支架200在植入病人体内前，需要先装载至输送系统100的管体10中，再由输送系统100输送至病人体内的病变部位。管腔支架200的装载过程如下：先将管腔支架200置于内鞘芯管13的外表面之上，并使锚定件22的变形部221及锁定部222穿过管腔支架200的近端的镂空处(即，波谷处骨架)，然后将锁定部222压向内鞘芯管13的方向，此时变形部221发生形变并相对内鞘芯管13弯折，使得锁定部222、变形部221及内鞘芯管13配合形成锚状物，钩住管腔支架200，管腔支架200被固定于内鞘芯管13的外部。再向远端推送外鞘管12，锚定件22被压缩并收容于外鞘管12和内鞘芯管13之间的空腔中。继续向远端推送外鞘管12，直至管腔支架200自近端至远端逐渐被压缩并收容于外 鞘管12和内鞘芯管13之间的空腔中。装载完成后，管腔支架200通过锚定单元20固定于内鞘芯管13之上，且锚定单元20限制管腔支架200与内鞘芯管13之间的相对移动。
可以理解的是，在管腔支架200的装载过程中，当管腔支架200被固定于内鞘芯管13的外部之后，也可以保持内鞘管11的位置不变，驱动内鞘管11相对于外鞘管12向近端轴向运动，达到将锚定件22及管腔支架200收容至外鞘管12及内鞘芯管13之间的空腔中的目的。
当装载有管腔支架200的管体10到达病变位置，准备释放管腔支架200时，向近端后撤手柄30的第二壳体32，驱动外鞘管12相对于内鞘芯管13向近端轴向运动。当锁定部222自外鞘管12与内鞘芯管13之间的空腔中释放后，变形部221也可以恢复至自然展开状态，此时锚定件22与管腔支架200自动分离，即，管腔支架200不再与内鞘芯管13连接。当外鞘管12继续相对于内鞘芯管13向近端轴向运动，管腔支架200自外鞘管12中释放，并依靠自身超弹性膨胀并贴附血管壁。
当管腔支架200未完全释放，且管腔支架200已释放的部分较短时，可直接回撤整个管体10，调整管体10远端的位置，并在数字影像辅助下，通过管腔支架200上的显影标记点观察，直至管体10的远端调整至较理想的释放位置。当管腔支架200部分释放时，如果需要调整管腔支架200的释放位置，可以停止后撤外鞘管12，并将整个管体10向近端拉动。在拉动管体10的过程中，管腔支架200已经释放的部分会受到来自血管内壁或者与管腔支架200配合的其他支架或者植入式器械的摩擦力，这种摩擦力会导致管腔支架200仍未释放的部分及锚定件22受到朝向远端的拉力，导致原本钩住管腔支架200的变形部221与锁定部222也受到朝向远端的拉力并产生沿内鞘芯管13的径向向外展开的趋势。但是由于外鞘管12的内壁会抑制这种趋势，使变形部221与锁定部222及内鞘芯管13可以维持锚状物的配合。由此，管腔支架200始终被锚定单元20固定于内鞘芯管13上，操作者回撤管体10不会导致外鞘管12与管腔支架200之间发生相对运动，避免由于外鞘管12与管腔支架200之间的相对运动而导致管腔支架200提前释放。
因此，本发明提供的输送系统尤其适用于输送在释放过程中需要调整释放位置使得释放后的植入物与其他植入物互相配合的植入物，例如为同时开通主动脉弓部狭窄及左锁骨下动脉狭窄在左锁骨下动脉中放置烟囱支架或礼帽支架，或者输送气管支架、食道支架，实现产品释放位置的调整和回收。
当管腔支架200未完全释放时，外鞘管12内壁限制锁定部222及变形部221向外展开，管腔支架200仍然通过锚定单元20固定于内鞘芯管13之上。此时如果发现管腔支架200的选型与病变部位不匹配，需要更换管腔支架，可以驱动外鞘管12相对于内鞘芯管13向远端轴向运动，使得管腔支架200已经释放的部分重新被压缩并回收至外鞘管12与内鞘芯管13之间的空腔中，再将管体10撤出病人体内，更换适宜的管腔支架。
本实施例提供的输送系统100的使用过程包括如下步骤：
第一步：经皮穿刺置入导丝至病变部位；
第二步：将预装有管腔支架200的管体10沿导丝输送至病变部位；
第三步：驱动外鞘管12向近端移动。由此，外鞘管12相对于内鞘芯管13及管腔支架200发生轴向运动，管腔支架200逐渐自外鞘管12中释放。在医学影像辅助下，通过管腔支架200上的显影标记点，评估管腔支架200的初始释放位置是否满足临床要求。
第四步：若管腔支架200的初始释放位置较理想，可继续驱动外鞘管12相对于内鞘芯管13向近端轴向运动，直至管腔支架200自外鞘管12之中完全释放。
第五步：若管腔支架200的初始释放位置不理想，可停止后撤外鞘管12，回撤整个管体10，并调整管体10远端的位置。在调整管体10远端的位置的过程中，由于管腔支架200被锚定单元20固定于内鞘芯管13之上，管腔支架200与外鞘管12、内鞘芯管13之间均不发生相对移动，有效地避免管腔支架200自外鞘管12中提前释放。
第六步：当管体10远端被调整至较理想的释放位置，再次驱动外鞘管12相对于内鞘芯管13向近端轴向运动。当锚定件22自外鞘管12与内鞘芯管13之间的空腔中释放，锚定件22的变形部221及锁定部222恢复至自然展开状态，并与锚定的管腔支架200自动分离。此时，管腔支架200不再与内鞘芯管13连接，当管腔支架200全部自外鞘管12中释放后，由于管腔支架200具有超弹性，可自然膨胀并贴附病变部位的血管壁。
第七步：后撤手柄30，带动内鞘芯管13相对于外鞘管12向近端运动。待内鞘芯管13外表面的锚定件22收容于外鞘管12之中后，回撤整个输送系统100，将管体10自病人体内撤出。
本实施例提供的输送系统与现有技术相比，至少具有以下有益效果：
(1)当装载有管腔支架的管体在人体管腔内输送时，锚定件的锁定部穿过管腔支架端部的镂空后，锚定件的变形部朝内鞘芯管弯折并被约束在内鞘芯管和外鞘管之间，即使通过较弯曲的人体管腔部位时，锚定件也不会与管腔支架脱离，避免了现有技术的刚性凸起物会与外鞘管内壁之间产生缝隙，导致管腔支架自刚性凸起物脱落的风险。
(2)在装载有管腔支架的管体被输送至弯曲的人体血管，在弯曲血管的弯曲半径较大的一侧，内鞘芯管与外鞘管之间的间隙增大，此时如果整个管体受到弯曲的血管内壁的挤压作用或者由于操作者的推送导致管体弯折，锚定件受到外力作用，变形部就会发生弹性形变，并带动锁定部沿着内鞘芯管的径向向外展开。当较难发生弹性形变的锁定部的头端接触外鞘管内壁时，锁定部会停止向外展开并限制变形部继续向外展开。此时，整个锚定件达到稳定状态，管腔支架仍然通过锚定件被固定在内鞘芯管上。因此，本实施例的输送系统可以有效地避免管体在经过弯曲的血管部位时，锚定件与管腔支架发生分离。
(3)管腔支架被锚定单元固定于内鞘芯管之上，管腔支架可以自外鞘管之中逐渐释放，避免 了管腔支架突然释放后无法调整释放位置的缺点。
(4)当手术过程中需要调整管腔支架的释放位置时，操作者可以后撤管体并调整管体远端位置，在调整过程中，管腔支架被固定于内鞘芯管之上，且管腔支架与外鞘管之间不会发生相对运动，有效防止管腔支架自外鞘管之中提前释放。
(5)在手术过程中，当管腔支架被部分释放，如发现管腔支架的尺寸与病变部位不符合，由于管腔支架靠近近端的部分仍然通过锚定单元固定于内鞘芯管之上，可以通过驱动外鞘管相对于内鞘芯管向远端轴向运动，将已经释放的管腔支架重新回收至外鞘管与内鞘芯管之间的空腔之中，再将管体撤出病人体外，更换尺寸适宜的管腔支架。
(6)当锚定单元的锚定件自外鞘管与内鞘芯管之间的空隙中释放，变形部带动锁定部恢复自然状态，管腔支架与内鞘芯管之间不再通过锚定件连接，管腔支架可自外鞘管中快速释放并膨胀。
实施例二
本实施例提供的管腔支架输送系统的结构与实施例一提供的管腔支架输送系统100的结构基本相同。区别之处在于，本实施例中，紧箍件的结构、锚定件的数量及结构与实施例一的紧箍件的结构、锚定件的数量及结构均不同。
具体地，请参见图6a，本实施例中，锚定单元40包括具有一定壁厚的套管状的紧箍件41，及至少一个与紧箍件41相连的锚定件42。
请一并参见图6b，紧箍件41具有至少一对导孔411。导孔411包括设于紧箍件41的远端端面的第一孔411a，及设于紧箍件41的外壁的第二孔411b，且第一孔41a及第二孔41b之间相连通，构成一对导孔411。本实施例中，锚定件42的数量为三个。导孔411的数量为六对。可以理解的是在其他实施例中，导孔411可由紧箍件41的任意两个端面或者外壁之间至少一对彼此相通的导孔组成，例如但不限于紧箍件41的远端端面的第一孔与近端端面的第二孔组成，或者由紧箍件41的近端端面的第一孔与外壁的第二孔组成。
请一并参见图6c，每个锚定件42均包括由双股线构成的U型结构。每个U型结构均包括两根直杆及连接于两根直杆之间的圆弧杆。每个U型结构的两端分别贯穿紧箍件41的一对导孔411。故，U型结构的圆弧杆贴覆在紧箍件41的外壁上，作为锚定件42的固定部423。U型结构的两个直杆分别经由一对导孔411自紧箍件41的远端端面穿出，作为锚定件42的变形部421。锚定件42的锁定部422为中空的管状体，套设于U型结构的两个直杆的远端部并将两个直杆束缚在一起。由此，锁定部422可以限制U型结构自紧箍件41上脱落。可以理解的是，在其他实施例中，锁定部422也可以为球状体等其他形状，只要锁定部422的直径大于或者等于变形部421的直径，即可使得在变形部421与锁 定部422受到同等外力作用时，锁定部422的弹性形变量小于变形部421的弹性形变量。
锚定件42的U型结构为可以弯曲的线、丝、柱状物、条状物、带状物或者片状物等。U型结构可以由具有柔性的材料(例如高分子材料)制成。U型结构也可以由具有弹性的材料(例如合金材料)制成。本实施例中，每个U型结构均由镍钛丝编织而成。
可以理解的是，在其他实施例中，锚定件还可以具有L型、S型或者V型等其他形状，只要锚定件的变形部可以弯曲并穿过导孔即可。
请参见图6d，当锁定部422及变形部421被收容于外鞘管及内鞘芯管之间的空腔中时，变形部421向内鞘芯管的方向弯折，此时，变形部421、锁定部422及内鞘芯管三者形成锚状物。并且外鞘管的内壁限制变形部421及锁定部422沿着内鞘芯管径向向外展开。
请一并参见图7，在锁定部422收容于外鞘管中时，锁定部422沿内鞘芯管的轴向的长度L2大于内鞘芯管与外鞘管之间的间隙w。由此，当锁定部422仅部分收容于外鞘管与内鞘芯管之间的空腔中时，锁定部422也不会向远离内鞘芯管的方向展开，可以保持变形部421及锁定部422与内鞘芯管之间的配合，以形成锚状物。同时，锁定部422沿内鞘芯管的轴向的长度L2优选大于0.1mm，小于15mm，以保证锁定部422在锚定状态下的稳定性，同时当变形部421及锁定部422自外鞘管12与内鞘芯管13之间的空腔中释放时，锁定部422之间不会彼此接触，避免多个锚定件22之间相互干涉而影响锚定件42与管腔支架之间顺利分离。
锁定部422的直径小于内鞘芯管与外鞘管之间的间隙w，以便于锁定部422能收容于内鞘芯管与外鞘管之间的空腔中。
本实施例的输送系统用于输送管腔支架200时，管腔支架200的装载过程如下：请参见图8a，先将锚定件42的变形部421及锁定部422穿过管腔支架200的近端的波谷处的金属骨架，然后将锁定部222压向内鞘芯管的方向，使得变形部421向近端弯折，此时锁定部222、变形部221及内鞘芯管配合形成锚状物，钩住管腔支架200。接着驱动内鞘管相对外鞘管向近端轴向运动，将锚定件42的锁定部422及变形部421收容至外鞘管及内鞘芯管之间的空腔中。请参见图8b，继续后撤内鞘管，直至管腔支架被逐渐压缩并收容至外鞘管及内鞘芯管之间的空腔中。
本实施例提供的输送系统，与现有技术相比，至少具有如下有益效果：
本实施例的输送系统中，锚定件的变形部具有U型结构，管状的锁定部套设于U型结构的远端并且将U型结构的两根直杆束缚在一起，可以避免锚定件自紧箍件上脱落，提高管腔支架与锚定单元之间的连接的可靠性。
可以理解的是，在其他实施例中，紧箍件41可只设有一对导孔411，仅有一个锚定件42与紧箍件导孔连接固定。
实施例三
本实施例提供的管腔支架输送系统的结构与实施例一提供的管腔支架输送系统100的结构基本相同。区别之处在于，本实施例中，内鞘芯管及紧箍件的结构、锚定件的数量及结构与实施例一的内鞘芯管及紧箍件的结构、锚定件的数量及结构均不同。
具体地，请参见图9a，本实施例中，锚定单元50包括套管状的紧箍件51及五个与紧箍件51相连的锚定件52。锚定件52包括与紧箍件51相连的变形部521及与变形部521相连的球状的锁定部522。
锚定单元50由管体壁厚范围为0.05毫米至2毫米的镍钛管激光雕刻而成。雕刻时，先在镍钛管的一端雕刻五个直杆形成变形部521(如图9b所示)，再将变形部521的一端通过激光点焊工艺焊成圆球状的锁定部522(如图9a所示)。
请参见图10，本实施例中，内鞘管61的靠近远端的管体内径大于内鞘管61的靠近近端的管体内径。请一并参见图11，由此，锚定单元50的紧箍件51可沿着图11中的箭头指示方向嵌入内鞘管61的靠近远端的管体及内鞘芯管(图未示出)之间。当紧箍件51的近端端面抵顶内鞘芯管的远端端面后，再通过点胶等本领域常用的技术手段将紧箍件51与内鞘管61及内鞘芯管固定在一起。
请同时参见图12a及图12b，内鞘管61的外表面设有用于容纳变形部521的收容槽611及用于容纳锁定部522的收容孔612。故，在变形部521及锁定部522相对于内鞘管61发生弯折，变形部521被收容于内鞘管61的外表面的收容槽611内之后，锁定部522被收容于内鞘管61的外表面的收容孔612内，进一步地限制锁定部522发生移动，提高管腔支架200与锚定件52之间的连接的可靠性。
在本实施例中，锁定部522沿径向的长度应大于内鞘管61以及收容槽611与外鞘管的间隙，以防止锁定部522意外脱出。
可以理解的是，在其他实施例中，锚定单元50可以设置在内鞘芯管较为靠近远端的管体外表面，故，紧箍件51的近端端面不会抵顶内鞘管61的远端端面。在这种实施方式中，可以在紧箍件51的外表面设置用于容纳变形部521的收容槽及用于容纳锁定部522的收容孔。
请参见图13a，在其他实施例中，锚定件的数量可以仅为一个。请参见图13b，锚定件的变形部在自然状态下(即，未收容于外鞘管中时)的长度应当大于内鞘芯管的外径，以保证变形部可以顺利地弯折，并且保证在变形部弯折后，锁定部能贴覆至内鞘芯管的外壁。请参见图13c，在变形部及锁定部依次穿过管腔支架近端的波谷处的金属骨架后，变形部弯折，锁定部贴覆至内鞘芯管的外壁，由外鞘管限制锁定部的移动，达到固定管腔支架的目的。变形部及锁定部优选为依次穿过管腔支架近端的对称设置的两个波谷处的金属骨架。可以理解的是，变形部及锁定部也可以仅穿过1个波谷处的骨架或者更多数量的波谷处的骨架。
另外，在这种仅有一个锚定件的实施方式中，内鞘芯管的外壁优选设置用于容纳锚定件的锁定部的收容槽，且收容槽优选设置在锚定件的对侧附近。由此，在管腔支架的装载过程中，操作者将 锚定件的变形部及锁定部穿过管腔支架的近端波谷处的金属骨架，然后将变形部及锁定部弯折后，将锁定部收容至收容槽中。此时，收容槽与外鞘管的内壁配合，可以更好地限制锁定部及变形部的移动，避免管腔支架在输送过程中产生偏移。本实施例提供的输送系统，与现有技术相比，至少具有如下有益效果：
变形部及锁定部被收容于内鞘芯管的外表面的收容空间内，收容空间与外鞘管的内壁相配合，进一步地限制锁定部及变形部发生移动，提高管腔支架与锚定件之间的连接的可靠性。实施例四
本实施例提供的植入物800输送系统的结构与实施例三提供的管腔支架输送系统100的结构基本相同。区别之处在于，本实施例中，输送器不具有内鞘管及紧箍件，锚定件的数量及与内鞘芯管连接结构与实施例三的数量及结构均不同。
具体地，请参见图14a及14b，本实施例中，锚定单元70包括4个与内鞘芯管13相连的锚定件71。锚定件71包括与内鞘芯管13相连的变形部711及与变形部711相连的锁定部712。变形部711通过激光焊接(不限于)的方式与内鞘芯管13相连接。
请参见图14c，本实施例中，内鞘芯管13与外鞘管12的间隙形成了用于收容锚定件71的收容空间，在变形部711及锁定部712相对于内鞘芯管13发生弯折后，收容于内鞘芯管13与外鞘管12之间。
请参见图14d，为保证锚定件71不会因变形部711的回弹而提前松脱，锚定件锁定部712沿内鞘芯管轴向长度L1应大于内鞘芯管13与外鞘管12的间隙w，为能在后撤外鞘管12后顺利解锁锚定件71，锚定件锁定部712沿内鞘芯管轴向长度L1应优选为大于0.1mm，小于15mm。
可以理解的是，在其他实施例中，锚定单元的数量可以仅为一个，也可多个分布于内鞘芯管上。本实施例进一步简化了输送系统，在保证锚定单元不提前松脱的前提下减少了必要的零部件，减少了生产及组装难度。
实施例五
本实施例提供的植入物输送系统的结构与实施例一提供的管腔支架输送系统的结构基本相同。区别之处在于，本实施例中，锚定件锁定部为高分子球状物，可以理解的是在其他实施例中可采用金属等其他具有一定硬度的材料，通过注塑等方式与变形部的一端相固定，变形部另一端与紧箍件固定。
请参见图15，锁定部在变形部弯曲变形后收容于紧箍件的近端端面，在变形部受到外力时，锁定部被紧箍件限制距离无法松脱。为达到该效果，紧箍件与外鞘管的间隙W应小于锁定部的经长W1。
可以理解的是，在其他实施例中，锁定部可以为不规则的其他形状，但其在收容状态沿径向的线度应大于紧箍件与外鞘管的间隙。
可以理解的是，在其他实施例中，锚定单元的数量可以仅为一个，也可多个分布于内鞘芯管上。
实施例一至实施例五仅以管腔支架的输送系统为例，对本发明的具体实施方式做了解释说明，可以理解的是，本发明的输送系统在用于输送其他植入物时，变形部及锁定部可以穿过植入物近端或者远端的骨架、通孔、回收钩、环状物或者其他具有镂空的部分。例如，在用于输送临时滤器时，变形部及锁定部可以通过滤器近端的回收钩与滤器相连。在用于输送心脏封堵器时，可以通过心脏封堵器近端的端头与心脏封堵器相连。
本发明提供的输送系统适用于输送血管支架，例如为同时开通主动脉弓部狭窄及左锁骨下动脉狭窄在左锁骨下动脉中放置烟囱支架或礼帽支架，或输送气管支架、食道支架，实现产品释放位置的调整和回收。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 植入物的输送系统，包括内鞘芯管，和可动地套设于所述内鞘芯管外部具有空腔的外鞘管；其特征在于，所述输送系统还包括固定于所述内鞘芯管的外表面的至少一个锚定单元，所述锚定单元包括套设于所述内鞘芯管的外表面的紧箍件及至少一个与所述紧箍件相连的锚定件，所述锚定件包括可相对所述内鞘芯管弯折的变形部及与所述变形部相连的锁定部，所述变形部与所述锁定部在收容于所述外鞘管与所述内鞘芯管之间的空腔内时，与所述紧箍件配合形成锚状物。
  2. 根据权利要求1所述的植入物的输送系统，其特征在于，在所述变形部与所述锁定部受到同等外力作用时，所述锁定部的弹性形变量小于所述变形部的弹性形变量。
  3. 根据权利要求2所述的植入物的输送系统，其特征在于，制成所述锁定部的材料的弹性模量小于或者等于制成所述变形部的材料的弹性模量。
  4. 根据权利要求1所述的植入物的输送系统，其特征在于，所述锁定部的直径大于或者等于所述变形部的直径。
  5. 根据权利要求4所述的输送系统，其特征在于，所述锁定部为套设于所述变形部的远端部的中空的管状体或者球状体。
  6. 根据权利要求1所述的植入物的输送系统，其特征在于，在所述锁定部收容于所述外鞘管中时，所述锁定部沿所述内鞘芯管的轴向的长度大于所述紧箍件与所述外鞘管之间的间隙。
  7. 根据权利要求1所述的输送系统，其特征在于，所述锁定部的长度大于0.1mm，小于15mm。
  8. 根据权利要求1所述的输送系统，其特征在于，所述锚定件还包括连接于所述紧箍件及所述变形部之间的固定部。
  9. 根据权利要求1所述的输送系统，其特征在于，所述锚定单元包括1至12个锚定件。
  10. 根据权利要求9所述的输送系统，其特征在于，所述锚定件围绕所述内鞘芯管的中心轴呈对称或者不对称设置。
  11. 根据权利要求1所述的输送系统，其特征在于，所述紧箍件的外表面或者所述内鞘管的外表面设有用于容纳所述锁定部及所述变形部的收容空间。
  12. 根据权利要求1所述的输送系统，其特征在于，所述紧箍件的任意两个端面或外壁之间具有至少一对彼此相通的导孔，所述锚定件具有双股线构成的U型结构，所述U型结构的两端分别贯穿一对所述导孔。
  13. 根据权利要求1所述的输送系统，其特征在于，所述内鞘管的靠近远端的管体内径大于所述内鞘管的靠近近端的管体内径，所述锚定单元的紧箍件嵌入所述内鞘管的靠近远端的管体及所述内鞘芯管之间。
  14. 植入物的输送系统，包括内鞘芯管，和可动地套设于所述内鞘芯管外部具有空腔的外鞘管， 其特征在于，所述输送系统还包括固定于所述内鞘芯管的外表面的至少一个锚定单元，所述锚定单元包括至少一个与所述内鞘芯管相连的锚定件，所述锚定件包括可相对所述内鞘芯管弯折的变形部及与所述变形部相连的锁定部，所述变形部与所述锁定部在收容于所述外鞘管与所述内鞘芯管之间的空腔内时，与所述内鞘芯管配合形成锚状物。
  15. 根据权利要求14所述的植入物的输送系统，其特征在于，在所述锁定部收容于所述外鞘管中时，所述锁定部沿所述内鞘芯管的轴向的长度大于所述内鞘芯管与所述外鞘管之间的间隙。
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