WO2023143607A1 - 用于递送植入物的接合组件、芯组件、系统和方法 - Google Patents

用于递送植入物的接合组件、芯组件、系统和方法 Download PDF

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Publication number
WO2023143607A1
WO2023143607A1 PCT/CN2023/073841 CN2023073841W WO2023143607A1 WO 2023143607 A1 WO2023143607 A1 WO 2023143607A1 CN 2023073841 W CN2023073841 W CN 2023073841W WO 2023143607 A1 WO2023143607 A1 WO 2023143607A1
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Prior art keywords
implant
pin head
delivering
proximal
pin
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PCT/CN2023/073841
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English (en)
French (fr)
Inventor
康尼夫布伦丹
华新
沈泉
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苏州徕瑞医疗技术有限公司
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Publication of WO2023143607A1 publication Critical patent/WO2023143607A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device

Definitions

  • the present invention relates to engagement assemblies, core assemblies, systems and methods for delivering implants.
  • Minimally invasive intervention is a treatment for vascular aneurysms, usually involving the delivery of vascular implants, such as but not limited to stents, coils, and aneurysm closure devices, to the lesion site through a delivery system.
  • the delivery system typically includes a catheter, a guidewire, and an implant engagement assembly, wherein the catheter is used to insert the vessel to accommodate the vascular implant and guide the vessel implant to the lesion in the vessel; the guidewire engages the implant A part of the assembly is usually fixedly connected; the implant engaging assembly is usually in contact with the implant for delivering the implant along the catheter to the lesion site under the action of the guide wire.
  • Implants are not always deployed in the precise location that a physician or surgical operator may want, so it may be necessary to retract the implant into the catheter before fully deploying it.
  • the implant is usually released immediately after being pushed out of the distal end of the catheter, and cannot be recovered into the delivery tube for re-release. In this case, even if the implant is not in the correct release position, adjustments cannot be made. This can cause unfavorable complications to the operation and increase the risk of the operation.
  • the known patent CN112716667A discloses a fixed and holding structure for intravascular implants and a delivery system for intravascular implants, which includes: a delivery tube, a guide wire running through the delivery tube, and a support connected to the guide wire device.
  • the guide wire and the delivery tube remain relatively fixed, and the supporter is located at the head of the delivery tube and plays a role in fixing the implant; out, the implant is released.
  • the implant can be retracted to the adjusted position in the delivery tube through the guide wire and released again.
  • patent CN112716667A has the following problems:
  • the implant drives the implant along the The delivery tube slides, and due to changes in the shape of the blood vessel may lead to changes in the friction between the two and the influence of the flatness of the inner wall of the catheter, the relative sliding of the implant and the holder may occur, and the implant may even fall off from the holder, so it is possible Can affect the delivery of the implant in the delivery tube.
  • the relative position of the implant and the holder is uncertain during assembly, and the relative sliding that may occur during the delivery process exacerbates the uncertainty of the relative position between the two, which may make the implant
  • the release position is inaccurate, and then the position of the implant needs to be adjusted many times, which may lead to a decrease in the release efficiency of the stent, increase the length of the operation, and increase the risk of the operation.
  • An object of the present invention is to provide a joint assembly for delivering implants, which can ensure the delivery of the implants to the lesion site, and at the same time recover the implants after release, allowing the implants to recover as needed. re-locate.
  • Another object of the present invention is to provide a core assembly for delivering an implant.
  • Another object of the present invention is to provide a system for delivering an implant.
  • Yet another object of the present invention is to provide a method for delivering an implant.
  • an engagement assembly for delivering an implant adapted to grip and release the implant as it is delivered via a catheter.
  • the engaging assembly comprises: a pin member comprising a pin head whose diameter gradually decreases from a distal end to a proximal end; a proximal pusher comprising a chamber adapted to receive the pin head, the chamber The surface of the pin head is in clearance fit with the surface of the pin head; the proximal end of the proximal pusher is apertured; wherein the proximal end of the pin element is in contact with the distal end of the first elongated delivery member in the catheter A fixed connection is achieved via the opening, and the proximal end of the proximal pusher is fixedly connected to the distal end of the second elongated delivery member in the catheter; wherein the pin head can pass through the first elongated delivery member. Relative movement between the delivery member and the second elongated delivery member moves relative to the proximal pusher
  • the engagement assembly includes a clamped state in which the pin head is located within a cavity of the proximal pusher and a surface of the pin head and a surface of the cavity
  • the gap is no greater than the thickness of the implant to enable clamping of the proximal end of the implant between the pin head and the cavity of the proximal pusher.
  • said engagement assembly comprises a released condition in which a gap between a surface of said pin head and a surface of said chamber is greater than the thickness of said implant such that said implanted The object can be released from the engagement assembly.
  • the diameter of the pin head decreases linearly from the distal end to the proximal end; or the diameter of the pin head decreases nonlinearly from the distal end to the proximal end; or the diameter of the pin head decreases from the distal end to the proximal end piecewise linear subtraction Small.
  • the pin head is a conical or frusto-conical pin head.
  • the angle between the conical surface of the conical or frusto-conical pin head and the central axis is no more than 30 degrees, more preferably no more than 20 degrees.
  • the length of the proximal end of the implant clamped between the pin head and the cavity of the proximal pusher accounts for 5%-30% of the total length of the implant. %.
  • the first elongated delivery member is a guide wire and the second elongated delivery member is a tubular member sleeved over the guide wire.
  • said tubular member is a hypotube.
  • the proximal end of the pin element is fixedly connected to the first elongated delivery member in a manner of welding, bonding, hinged and/or clamping, and the proximal end of the proximal pusher is connected to the first elongated delivery member.
  • the two elongated delivery parts are fixedly connected by means of welding, bonding, hinge and/or clamping.
  • the pin element further includes a pin shank connected to the pin head, and the pin head is fixedly connected to the first elongated delivery member via the pin shank; there is a gap between the opening and the pin shank Cooperate.
  • the pin head and the pin shank are integrally formed.
  • the proximal pusher has a cylindrical outer surface; the diameter of the most distal end of the pin head is smaller than the diameter of the cylindrical outer surface of the proximal pusher.
  • the diameter of the bore is smaller than the diameter of the most proximal end of the pin head.
  • a core assembly for delivering an implant.
  • the core assembly comprises an engagement assembly for delivering an implant according to the first aspect of the invention, further comprising: a first elongated delivery member and a second elongated delivery member located in the catheter.
  • a system for delivering an implant comprises a core assembly for delivering an implant according to the second aspect of the invention, further comprising a catheter and an implant.
  • a method for delivering an implant employs a joint assembly for delivering an implant according to the first aspect of the present invention, the method comprising: pushing the first elongated delivery member and the second elongated delivery member simultaneously relative to the The second elongated delivery member pulls back the first elongated delivery member to deliver the engagement assembly and implant within the catheter to a designated location in the hollow anatomical structure, and the proximal end of the implant The end is clamped between the pin head and the chamber of the proximal pusher; after the implant reaches the designated position, the catheter is pulled proximally, causing the engagement assembly and the implant to protrude from the catheter; the first elongated delivery member, make the pin head leave the chamber of the pusher, and judge whether the position of the implant needs to be adjusted: if the position of the implant needs to be adjusted, then pull back the first elongated delivery member, Re-enter the pin head into the cavity of the proximal push
  • the present invention has the following advantages:
  • the pin head whose diameter gradually decreases from the distal end to the proximal end and the chamber of the proximal pusher can ensure a large pushing force and clamping force, and prevent the implant from breaking free and falling off accidentally. This is because, on the one hand, during delivery of the implant, the lumen surface of the proximal pusher actually abuts against the engagement portion of the implant, thereby exerting a forward force on the engagement portion of the implant.
  • the thrust this kind of abutting thrust is more stable and reliable than the thrust generated only by friction; In the same situation, the contact area with the implant can be increased, and the clamping force increases with the increase of the pulling force of the pin head, so the clamping force of the implant can be effectively ensured and regulated.
  • Fig. 1 shows a schematic structural view of a delivery system according to an embodiment of the present invention
  • Fig. 2 shows a schematic diagram of disengaging the distal end of the pin element from the proximal pusher when preparing to release the stent in the delivery system according to an embodiment of the present invention
  • Fig. 3 shows a schematic diagram of a fully released stent in a delivery system according to an embodiment of the present invention.
  • distal refers to a position or direction relative to the surgical operator.
  • distal refers to a location or direction away from the surgical operator.
  • connection refers to the existence of a connection relationship between two elements, which not only includes the situation where the two elements are directly connected or in contact, but can also be understood as including the relationship between the two elements through a The case where a plurality of intermediate elements are connected can also be understood as including the case where two elements are integrally formed.
  • fixed connection refers to a connection with almost no relative movement after two elements are fixed, including detachable connections and non-detachable connections.
  • Fig. 1 shows a schematic structural diagram of a delivery system 10 according to an embodiment of the present invention.
  • the delivery system of the present invention may be used to deliver and/or deploy an implant, such as a stent, into a hollow anatomical structure, such as a blood vessel.
  • an implant such as a stent
  • the delivery system of the present invention includes a stent 11 , a core assembly and a catheter 13 .
  • the stent 11 may include a braided stent or other forms of stents, for example, laser-cut stents, rolled stents, and the like.
  • the stent 11 may be braided from round or oval wire filaments.
  • the stent 11 is self-expandable, and one or more filaments may be formed of biocompatible metal materials or biocompatible polymers.
  • the catheter 13 is located outside the core assembly, the core assembly can slide relatively inside the catheter, and the core assembly can be configured to carry the stent through the catheter. Once the distal end of the catheter 13 is at the desired location, the stent 11 can be pushed out of the catheter 13 either by withdrawing the catheter 13 or by pushing the core assembly.
  • the catheter 13 is an elongated structure, including a proximal end, a distal end and a central chamber. The distal end of the catheter 13 is provided with an opening, so that the core assembly carrying the stent 11 extends out of the catheter 13 from the opening to release the stent 11 .
  • the catheter 13 can be a microcatheter or a sheath tube.
  • the core assembly is located in the central cavity of the conduit 13 and can move axially relative to the conduit 13 as a whole.
  • the core assembly can be advanced within the lumen of catheter 13 (or catheter 13 can be retracted) to expose stent 11 and allow it to expand within the patient's vessel.
  • the core assembly includes the engagement assembly, the second elongated delivery member 15 and the first elongated delivery member, among others.
  • An engagement assembly is located at the distal ends of the first and second elongated delivery members, and the proximal end of the stent 11 engages with the engagement assembly to allow the user to push the crimped stent 11 forward through the catheter 13 .
  • the engagement assembly further comprises a pin element 41 and a proximal pusher 42 .
  • the pin member 41 may comprise a connected pin head 43 and a pin shank 44, wherein the pin head 43 and the pin shank 44 are located at the distal end and the proximal end of the pin member 41, respectively.
  • Pin shank 44 is rod-shaped, rod-shaped or flat strip
  • pin head 43 is the structure that diameter gradually reduces from far end to near end, and the diameter of pin head 43 is from far end This gradual decrease proximally may be a linear decrease or a non-linear decrease.
  • the structure of the pin head 43 is a conical structure or a frusto-conical structure.
  • the structure of the pin head 43 is generally conical or other suitable structures, such as gyro-shaped, trumpet-shaped or bell-shaped. Furthermore, this reduction can also be a segmented linear reduction.
  • the pin head 43 may include a distal section and a proximal section, wherein the distal section and the proximal section are frusto-conical structures with different apex angles.
  • the included angle between the conical surface of the conical or frusto-conical pin head and the central axis is not more than 30 degrees, preferably not more than 20 degrees. Such an angle can make the bracket 11 more firmly and stably clamped between the pin head 43 and the proximal pusher 42 without easily deforming the bracket 11 .
  • the pin head 43 and the pin handle 44 are integrally formed.
  • the pin head 43 and the pin shank 44 can also be molded separately, and fixedly connected by means of welding, bonding, hinge joint and/or snap joint.
  • the outer surface of the proximal pusher 42 is cylindrical and includes an open cavity, the cavity of the proximal pusher 42 can be used to receive the pin head 43 of the pin element 41 .
  • This cavity is a clearance fit with the pin head 43 of the pin element 41 .
  • the diameter of the chamber of the proximal pusher 42 also decreases gradually from the distal end to the proximal end.
  • the proximal end of the proximal pusher 42 has an opening matching the pin handle 44 of the pin element 41 .
  • matching here means that the size of the pin shank 44 is substantially equivalent to the opening, so that the pin shank 44 can pass through the opening.
  • the shape of the cross section of the pin handle 44 can be completely consistent with the shape of the opening, or not, as long as it is ensured that the pin handle 44 can pass through the opening.
  • the opening is preferably located at the proximal center of the proximal pusher 42 .
  • the engagement component includes a clamped state and a released state.
  • the pin head 43 in the joint assembly is located in the chamber of the proximal pusher 42, and there is a certain gap between the surface of the pin head 43 of the pin element 41 and the surface of the chamber of the proximal pusher 42 45, the gap 45 is used to accommodate the proximal end of the stent 11, and the thickness of the gap 45 is not greater than the thickness of the stent, which can ensure that the stent is firmly gripped (firmly gripping), that is, the proximal end of the stent 11 The portion can be clamped between the pin head 43 and the cavity of the proximal pusher 42 .
  • the gap between the surface of the pin head 43 and the surface of the cavity is greater than the thickness of the bracket 11 to enable the release of the bracket 11 from the engagement assembly.
  • the pin head 43 may be completely outside the chamber of the proximal pusher 42 or not completely leave the chamber of the proximal pusher 42 .
  • the length of the proximal end of the stent 11 clamped between the pin head 43 and the cavity of the proximal pusher 42 preferably accounts for 5%-30% of the total length of the stent.
  • Such a clamping ratio can ensure that the stent 11 is more stably and securely clamped, preventing the stent 11 from falling off or slipping relative to the joint assembly during delivery, thereby affecting the accuracy of the release position of the stent, and is not easy cause the bracket to deform.
  • the distal end of the first elongated delivery member is fixedly connected to the proximal end of the pin handle 44 of the pin element 41 via the opening of the proximal pusher, and the distal end of the second elongated delivery member 15 is connected to the proximal end of the proximal pusher 42. End fixed connection.
  • the fixed connection between the first elongated delivery member and the pin shank 44 of the pin element 41 and the fixed connection between the second elongated delivery member 15 and the proximal pusher 42 can be achieved by welding, bonding, hinged and/or snapping. Implemented in a similar manner.
  • the pin element 41 includes a pin shank 44, and that the pin head 43 is connected to the first elongated delivery member through the pin shank 44, in fact the pin element 41 does not necessarily include a pin shank 44 .
  • the distal end of the first elongated delivery member can also be directly fixedly connected to the pin head 43 via the opening at the proximal end of the proximal pusher 42 , at this time, the opening at the proximal end of the proximal pusher 42 The aperture mates with the distal end of the first elongated delivery member.
  • the distal end of the first elongated delivery member directly exerts push and pull control on the pin head 43 .
  • the existence of the pin handle 44 is also advantageous, for example, the pin element 41 and the elongated delivery member can be fixedly connected conveniently through the pin handle 44, which is more efficient and quicker during assembly.
  • the first elongated delivery member is a guide wire
  • the second elongated delivery member 15 is a delivery tube.
  • the delivery tube is sheathed on the guide wire, which can support and protect the guide wire to a certain extent.
  • the first elongated delivery member and the second delivery member may also include guide wires, delivery tubes, coils or any combination thereof.
  • the guide wire can be a metal filament made of metal material, and its specific shape and structure will not be repeated here.
  • the delivery tube may be a hypotube or other suitable tubular structure.
  • the diameter of the most distal end of the pin head 43 is smaller than the diameter of the cylindrical outer surface of the proximal pusher 42 . In this way, when the pin head 43 fully enters the chamber of the proximal pusher 42 , the most distal end of the pin head 43 will not protrude beyond the proximal pusher 42 in the radial direction.
  • the diameter of the hole is smaller than the diameter of the proximal end of the pin head 43, and the diameter of the hole is greater than or equal to the diameter of the pin shank 44, so that the pin head 43 can be stuck in when the pin shank 44 is pulled back by the guide wire. In the chamber of the proximal pusher 42.
  • the axial movement of the pin element 41 and the proximal pusher 42 along the catheter 13 can be controlled respectively by controlling the axial movement of the delivery tube and the guide wire along the catheter 13, so as to realize the clamping of the stent 11, Deliver, release, re-clamp and re-release.
  • the pin element 41 moves forward relative to the proximal pusher 42 so that the pin head 43 of the pin element 41 clears the lumen of the proximal pusher 42 to facilitate release.
  • the pin member 41 moves rearwardly relative to the proximal pusher 42, and the pin head 43 of the pin member 41 enters the cavity of the proximal pusher 42 to facilitate engagement Or re-engage the proximal end of the stent 11.
  • the engaging assembly remains engaged with the proximal end of the stent 11 and simultaneously pushes the stent 11 to the distal end.
  • bracket 11 since the bracket 11 is actually wrapped and gripped tightly in the cavity of the proximal pusher 42, and the cavity is adapted to the shape of the pin head 43, its diameter also gradually increases from the distal end to the proximal end. Therefore, during delivery of the stent 11 , the chamber surface of the proximal pusher 42 actually abuts against the engaging portion of the stent 11 , thereby generating a forward thrust on the engaging portion of the stent 11 . This thrust against thrust is completely different from the thrust generated by purely relying on friction in the prior art.
  • the driving force generated by the abutment in the present invention is more stable and reliable, which can effectively prevent the stent 11 from colliding with the delivery device (for example, the stent engaging component, etc.) during the delivery process. Sliding, so that the stent 11 can be delivered to the lesion position more accurately, reducing the number of stent position adjustments, thereby saving operation time.
  • the delivery device for example, the stent engaging component, etc.
  • the implant is a stent and the delivery system for the stent, however other annular implants are also contemplated for delivery via the delivery system, such as microcoils, occluders or similar devices.
  • the stent can include a proximal end and a distal end.
  • the implant may be configured to interfere with blood flow for the purpose of treating an aneurysm, such as an aneurysm in a blood vessel, including an artery in the brain or elsewhere in the body, such as a peripheral artery.
  • a method for delivering an implant according to one embodiment of the present invention is described below.
  • FIG. 2 shows a schematic diagram of the disengagement of the distal end of the pin element 41 from the proximal pusher;
  • FIG. 3 shows a schematic diagram of the stent being completely released.
  • the method generally includes the following steps:
  • the joint assembly and the stent 11 are loaded into the catheter 13 and delivered via the catheter 13 to the vicinity of the designated location (ie, lesion) of the hollow anatomical structure.
  • the proximal end of the stent 11 is clamped between the pin head and the proximal pusher by manipulating the delivery tube and guide wire to keep the engagement assembly clamped while the stent 11 is being delivered within said catheter 13. between chambers.
  • the specific operation mode is to simultaneously push the delivery tube and the guide wire, and at the same time pull back the guide wire relative to the delivery tube, so as to keep the two relatively stationary during the delivery process, so that the joint assembly is clamped to the stent 11 and moves far away. Push the bracket 11 sideways to the designated position.
  • the joint assembly is in a release state by operating the delivery tube and the guide wire to prepare for releasing the stent, including pulling the catheter 13 proximally to make the joint assembly protrude from the catheter 13, so that Most of the stent (i.e.
  • the guide wire and delivery tube are pulled back simultaneously to pull the pin element 41 and the proximal pusher 42 in the proximal direction simultaneously, and the engagement assembly will still Keep the released state, meanwhile, the friction force between the support 11 and the tissue (for example, blood vessel wall) at the designated position keeps the position of the support 11 unchanged, and the withdrawal of the proximal pusher 42 makes the proximal end of the support 11 break away from the proximal pusher 42, so that the stent 11 is completely released.
  • the tissue for example, blood vessel wall

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Abstract

一种用于递送植入物的接合组件、芯组件、系统和方法，接合组件能够对植入物进行夹持和释放，接合组件包括：销元件（41），包括直径由远端向近端逐渐减小的销头（43）；和近端推动器（42），包括用于容纳销头的腔室，腔室的表面与销头（43）的表面间隙配合；近端推动器（42）的近端开有开孔；其中，销元件（42）的近端与导管中的第一细长递送件的远端经由开孔固定连接，近端推动器（42）的近端与导管（13）中的第二细长递送件（15）的远端固定连接；销头（43）能通过第一细长递送件与第二细长递送件（15）之间的相对运动而相对于近端推动器（42）沿导管（13）的纵轴方向移动，芯组件和系统包括接合组件。接合组件、芯组件、系统和方法能够将植入物在释放后进行回收和重新定位，且能有效防止植入物与接合组件之间滑移。

Description

用于递送植入物的接合组件、芯组件、系统和方法
相关申请的交叉援引
本申请要求申请日为2022.01.30、申请号为CN202210113811.7、发明名称为“用于递送植入物的接合组件、芯组件、系统和方法”的中国专利申请的优先权，在此通过援引将其全部内容并入本公开。
技术领域
本发明涉及用于递送植入物的接合组件、芯组件、系统和方法。
背景技术
微创介入是血管动脉瘤的一种治疗手段，通常涉及将血管植入物，例如但不仅限于支架、弹簧圈、动脉瘤封堵装置，通过递送系统递送至病变位置。该递送系统通常包括导管、导丝和植入物接合组件，其中导管用于插入血管以容纳血管植入物，并将血管植入物引导到血管中的病变部位；导丝与植入物接合组件的一部分通常固定连接；植入物接合组件通常是与植入物接触，用于在导丝的作用下将植入物沿导管递送到达病变位置。
然而植入物并不总是部署在医师或手术操作者可能想要的精确位置，因此可能需要在完全展开之前将植入物缩回到导管中。而常见的现有的输送系统中，在植入物被推出导管的远端后通常被即刻释放，无法再重新回收至递送管内重新释放。在这种情况下，即使植入物的释放位置不正确，也无法进行调整。这会给手术造成不利的并发症，增加了手术的风险。
为此，需要设计一种能够在植入物释放后重新将其回收至递送导管内以重新释放的递送系统。
目前，已知专利CN112716667A公开了一种血管内植入物固定保持结构和一种血管内植入物输送系统，其包括：输送管，贯穿输送管的导丝，及连接在导丝上的支持器。在输送初期，导丝与输送管保持相对固定，支持器位于输送管头部并对植入物起固定作用；在输送后期，导丝与输送管发生相对运动，支持器从输送管头部伸出，植入物实现释放。当植入物伸出输送管远端长度不超过一定数值时，植入物可通过导丝回收至输送管内调整位置重新释放。
然而，专利CN112716667A具有以下问题：
一方面，植入物是通过植入物与支持器之间的摩擦力来带动植入物沿 输送管滑动，而由于血管形态的弯曲变化可能导致两者摩擦力的变化以及导管内壁平整度的影响，植入物与支持器可能发生相对滑动，甚至植入物可能从支持器脱落，因此可能会影响到植入物在输送管中的输送。
另一方面，植入物与支持器在装配时的相对位置不确定，同时二者在递送过程中可能发生的相对滑动加剧了二者间相对位置的不确定性，从而可能使得植入物的释放位置不准确，进而需要多次调整植入物的位置，这可能导致支架释放效率的降低，增加手术时长和手术风险增加等问题。
发明内容
本发明的一个目的在于提供一种用于递送植入物的接合组件，在保证将植入物输送至病变位置的同时，还能够将植入物在释放后进行回收，允许植入物根据需要重新定位。
本发明的另一个目的在于提供一种用于递送植入物的芯组件。
本发明的另一个目的在于提供一种用于递送植入物的系统。
本发明的又一个目的在于提供一种用于递送植入物的方法。
根据本发明的第一方面，公开一种用于递送植入物的接合组件，适于在经由导管递送植入物时对所述植入物进行夹持和释放。该接合组件包括：销元件，包括直径由远端向近端逐渐减小的销头；近端推动器，所述近端推动器包括适于容纳所述销头的腔室，所述腔室的表面与所述销头的表面间隙配合；所述近端推动器的近端开有开孔；其中，所述销元件的近端与所述导管中的第一细长递送件的远端经由所述开孔实现固定连接，所述近端推动器的近端与所述导管中的第二细长递送件的远端固定连接；其中，所述销头能够通过所述第一细长递送件与所述第二细长递送件之间的相对运动而相对于所述近端推动器沿所述导管的纵轴方向移动，以使所述销头进入或离开近端推动器的腔室。
优选地，所述接合组件包括夹持状态，在所述夹持状态下，所述销头位于近端推动器的腔室内，且所述销头的表面和所述腔室的表面之间的间隙不大于所述植入物的厚度，以使所述植入物的近端端部能够夹固在销头和近端推动器的腔室之间。
优选地，所述接合组件包括释放状态，在所述释放状态下，所述销头的表面和所述腔室的表面之间的间隙大于所述植入物的厚度，以使所述植入物能够从所述接合组件释放。
进一步地，所述销头的直径由远端向近端线性减小；或所述销头的直径由远端向近端非线性减小；或所述销头的直径由远端向近端分段线性减 小。
优选地，所述销头为锥形或截头锥形销头。
优选地，所述锥形或截头锥形销头的圆锥面与中轴线的夹角不超过30度，更为优选地不超过20度。
优选地，在所述夹持状态下，夹固在销头和近端推动器的腔室之间的所述植入物的近端端部的长度占植入物总长度的5％-30％。
优选地，所述第一细长递送件为导丝，所述第二细长递送件为套设在导丝上的管状构件。
优选地，所述管状构件为海波管。
优选地，所述销元件的近端与所述第一细长递送件以焊接、粘接、铰接和/或卡接的方式固定连接，且所述近端推动器的近端与所述第二细长递送件以焊接、粘接、铰接和/或卡接的方式固定连接。
优选地，所述销元件还包括与所述销头相连的销柄，所述销头经由所述销柄与所述第一细长递送件固定连接；所述开孔与所述销柄间隙配合。优选地，所述销头和所述销柄一体成型。
优选地，所述近端推动器具有圆柱形外表面；所述销头的最远端的直径小于所述近端推动器的圆柱形外表面的直径。
优选地，所述开孔的直径小于所述销头的最近端的直径。
根据本发明的第二方面，提供一种用于递送植入物的芯组件。该芯组件包括根据本发明的第一方面的用于递送植入物的接合组件，还包括：位于导管中的第一细长递送件和第二细长递送件。
根据本发明的第三方面，公开一种用于递送植入物的系统。该系统包括根据本发明的第二方面的用于递送植入物的芯组件，还包括导管和植入物。
根据本发明的第四方面，公开一种用于递送植入物的方法。该方法使用了根据本发明的第一方面的用于递送植入物的接合组件，所述方法包括：推动所述第一细长递送件和所述第二细长递送件，同时相对于所述第二细长递送件回拉所述第一细长递送件，以在导管内将所述接合组件和植入物递送至中空解剖结构的指定位置，且使所述植入物的近端端部夹固在销头和近端推动器的腔室之间；在植入物到达所述指定位置后，向近侧拉动导管，使接合组件和植入物伸出所述导管；推动所述第一细长递送件，使销头离开推动器的腔室，并判断是否需要调整植入物的位置：若需要调整植入物的位置，则回拉所述第一细长递送件，使销头重新进入近端推动器的腔室内，以使所述接合组件重新夹持所述植入物；若无需调整植入物 的位置，则回拉所述第一细长递送件和第二细长递送件，以释放植入物并撤回所述接合组件。
与现有技术相比，本发明具有以下优点：
1、在保证将植入物输送至病变位置的同时，还能够将植入物在释放后进行回收，允许植入物根据需要重新定位。
2、直径由远端向近端逐渐减小的销头和近端推动器的腔室可以确保大的推进力度和夹持力度，防止植入物发生意外的挣脱和脱落。这是因为，一方面，在植入物的递送过程中，近端推动器的腔室表面实际上会与植入物的接合部分发生抵靠作用，从而对植入物的接合部分产生向前的推力，这种抵靠推力相较于仅由摩擦作用产生的推力而言更为稳固可靠；另一方面，直径由远端向近端逐渐减小的销头相对于圆柱形销头在长度相同的情况下可以增大与植入物的接触面积，且夹持力随着销头回拉力度的增大而增大，因而可以有效确保和调控植入物的夹持力度。
3、由于接合组件对植入物的抵靠作用和大的夹持力度，因而可以有效地防止植入物在递送过程中与递送装置(例如，支架接合组件等)发生滑移，使植入物截止点固定，从而能在依靠显影观察植入物的定位并结合递送操作以放置植入物的过程中，可以将植入物更精确地递送至病变位置，减小植入物位置调整的次数，节省手术时间。
附图说明
附图通过示例性但非限制性的方式对本发明的实施例进行图示，其中：
图1示出了根据本发明一个实施例的输送系统的结构示意图；
图2示出了根据本发明一个实施例的输送系统中准备释放支架时使销元件的远端与近端推动器脱离的示意图；
图3示出了根据本发明一个实施例的输送系统中支架被完全释放的示意图。
具体实施方式
下面通过实施例，并结合附图，对本发明的技术方案作进一步详细的说明，但本发明不限于下面的实施例。
除非另有定义，否则本文中使用的所有技术和科学术语与本领域普通技术人员通常理解的具有相同含义。尽管与本文描述的那些类似或等同的 任何方法和材料都可以用于本文描述的实施例的实践或测试中，但是本文描述了优选的方法，装置和材料。
术语“远端”、“远侧”或“近端”、“近侧”在以下描述中是指相对于手术操作者的位置或方向。“远端”或“远侧”是指远离手术操作者的位置或方向。
术语“相连”、“连接”或“固定连接”是指两个元件之间存在连接关系，其不仅包含两个元件直接相连或相接触的情况，还可以理解为包括两个元件之间通过一个或多个中间元件进行连接的情况，还可以理解为包括两个元件一体成型的情况。此外，术语“固定连接”是指将两个元件固定后,几乎没有相对运动的连接，包括可拆式连接和不可拆式连接。
图1示出了根据本发明的一个实施例的输送系统10的结构示意图。
根据该实施例，本发明的输送系统可用于将植入物(如支架)输送和/或展开到诸如血管的中空解剖结构中。如图1所示，本发明的输送系统包括支架11、芯组件以及导管13。
支架11可包括编织的支架或其它形式的支架，例如，激光切割支架、卷式支架等。在与编织支架相关的实施例中，所述支架11可由圆形或卵形线细丝编织而成。进一步地，所述支架11是自膨胀的，一根或多根细丝可以由生物相容性金属材料或生物相容性聚合物形成。
导管13位于芯组件的外部，芯组件可在导管内相对滑动，芯组件可以构造成可携带支架通过导管。一旦导管13的远端位于期望的位置处，可以通过撤回导管13的方式将支架11推出导管13，也可以通过推动芯组件将支架11推出导管13。所述导管13为细长结构，包括近端、远端以及中心腔室，导管13的远端设有开口，以便于芯组件携带支架11从开口处伸出导管13以释放支架11。所述导管13可以是微导管或护套管。
芯组件位于所述导管13的中心腔室内，可整体相对于导管13轴向移动。芯组件可在导管13的腔室内前进(或者导管13可缩回)以暴露支架11并允许它在患者的血管内扩张。所述芯组件包括接合组件、第二细长递送件15以及第一细长递送件等。接合组件位于第一细长递送件和第二细长递送件的远端，支架11的近端与接合组件接合，以允许使用者将卷曲的支架11从导管13中向前推出。
所述接合组件进一步包括销元件41和近端推动器42。
销元件41可以包括相连的销头43和销柄44，其中销头43和销柄44分别位于所述销元件41的远端和近端。销柄44为杆状、棒状或扁平的条状，销头43为直径由远端向近端逐渐减小的结构，销头43的直径由远端 向近端的这种逐渐减小可以是线性减小也可以是非线性的减小。当这种减小为线性减小时，销头43的结构为锥形结构或截头锥形结构。当这种减小为非线性减小时，销头43的结构为大致锥形结构或其它合适的结构，例如陀螺形、喇叭型或钟形等。此外，这种减小还可以是分段的线性减小。例如，销头43可以包括远端段和近端段，其中远端段和近端段是具有不同顶角的截头圆锥形结构。
特别地，当销头43为锥形或截头锥形销头时，锥形或截头锥形销头的圆锥面与中轴线的夹角不超过30度，优选不超过20度。这样的角度可以使支架11更加稳固和稳定地夹持在销头43和近端推动器42之间，且不容易使支架11变形。
在优选的实施例中，销头43和销柄44一体成型。在某些实施例中，销头43和销柄44也可以分别成型，并通过焊接、粘接、铰接和/或卡接等方式固定连接。
在优选的实施例中，近端推动器42的外表面呈圆柱形且包括一开放的腔室，所述近端推动器42的腔室可用于容纳所述销元件41的销头43。该腔室与所述销元件41的销头43间隙配合。换言之，近端推动器42的腔室直径也是由远端向近端逐渐减小。近端推动器42的近端开有与销元件41的销柄44匹配的开孔。此处的术语“匹配”是指，销柄44的尺寸与开孔大致相当，以使得销柄44可以从开孔穿过。同时，销柄44的横截面的形状可以与开孔的形状完全一致，也可以不一致，只要确保销柄44可以从开孔穿过即可。开孔优选位于近端推动器42的近端中央位置处。
接合组件包括夹持状态和释放状态。在夹持状态下，接合组件中的销头43位于近端推动器42的腔室内，且销元件41的销头43的表面和近端推动器42的腔室的表面之间有一定的间隙45，所述间隙45用于容纳支架11的近端，该间隙45的厚度不大于所述支架的厚度，这样可以确保支架被牢牢的抓紧(firmly gripping)，即使得支架11的近端端部能够夹固在销头43和近端推动器42的腔室之间。在释放状态下，销头43的表面和腔室的表面之间的间隙大于支架11的厚度，以使支架11能够从接合组件释放。在释放状态下，销头43可以完全位于近端推动器42的腔室之外，也可以未完全离开近端推动器42的腔室。
此外，在夹持状态下，夹固在销头43和近端推动器42的腔室之间的支架11的近端端部的长度优选地占支架总长度的5％-30％。这样的夹持比例可以确保支架11被更稳定和稳固地夹持，防止递送过程中支架11脱落或相对于接合组件产生滑移，从而影响支架释放位置的准确性，且不容易 引起支架变形。
第一细长递送件的远端与销元件41的销柄44的近端经由近端推动器的开孔实现固定连接，第二细长递送件15的远端与近端推动器42的近端固定连接。第一细长递送件与销元件41的销柄44之间的固定连接以及第二细长递送件15与近端推动器42之间的固定连接可以通过焊接、粘接、铰接和/或卡接等方式实现。
需要注意的是，虽然在先前的描述中提及销元件41包括销柄44，且销头43通过销柄44与第一细长递送件连接，但实际上销元件41并非必需包含销柄44。例如，在某些实施例中，第一细长递送件的远端也可以经由近端推动器42近端的开孔直接与销头43固定连接，此时近端推动器42近端的开孔与第一细长递送件的远端匹配。在这种情况下，第一细长递送件的远端直接对销头43进行推拉控制。当然，销柄44的存在也是有利的，例如通过销柄44可以方便地对销元件41和细长递送件进行固定连接，在装配时更加高效快捷。
本实施中，第一细长递送件为导丝，第二细长递送件15为递送管。递送管套设在导丝上，能够对导丝起到一定的支撑和保护作用。需要注意的是，其他实施例中，第一细长递送件和第二递送件还可以包括导丝、递送管、线圈或其任何组合。导丝可以是由金属材料制成的金属细丝，其具体形状和结构在此不再赘述。递送管可以是海波管或其它合适的管状结构。
此外，优选地，销头43的最远端的直径小于近端推动器42的圆柱形外表面的直径。这样一来，当销头43完全进入近端推动器42的腔室时，销头43的最远端不会在径向上超出近端推动器42。优选地，开孔的直径小于所述销头43的最近端的直径，且开孔的直径大于或等于销柄44的直径，以使得销头43在销柄44被导丝回拉时可以卡在近端推动器42的腔室中。
根据上述的设计，可以通过分别控制递送管和导丝沿导管13的轴向移动来分别控制销元件41和近端推动器42沿导管13的轴向移动，以实现对支架11的夹持、递送、释放、重新夹持与重新释放。
例如，当相对于递送管向前推动导丝时，销元件41相对于近端推动器42向前移动，以使销元件41的销头43离开近端推动器42的腔室，以便于释放支架11的近端。又例如，当相对于递送管向后拉动导丝时，销元件41相对于近端推动器42向后移动，销元件41的销头43进入近端推动器42的腔室中，以便于接合或重新接合支架11的近端。再例如，当销元件41的销头43完全进入近端推动器42的腔室中，且同时沿导管13向远端推动 递送管和导丝时，接合组件与支架11的近端保持接合状态，并同时将支架11推送至远端。
同时，根据上述设计，由于支架11实际上是被包裹握紧在近端推动器42的腔室中，且该腔室与销头43的形状相适应，其直径也是由远端向近端逐渐减小，因而支架11在递送过程中，近端推动器42的腔室表面实际上会与支架11的接合部分发生抵靠作用，从而对支架11的接合部分产生向前的推力。这种抵靠推力与现有技术中单纯依靠摩擦作用产生的推动力是完全不同的。相对于由摩擦作用产生的推动力而言，本发明中由抵靠作用产生的推动力更为稳固可靠，可以有效地防止支架11在递送过程中与递送装置(例如，支架接合组件等)发生滑移，从而使支架11可以更精确地递送至病变位置，减小支架位置调整的次数，进而节省手术时间。
本实施例讨论了植入物为支架时的情形以及关于支架的输送系统，然而其他环形植入物也可以考虑通过该输送系统进行递送，诸如微线圈、封堵器或类似设备。所述支架可包括近端和远端。所述植入物可以被构造成干扰血液流动以达到治疗动脉瘤的目的，例如血管中的动脉瘤，所述血管包括在脑中或在身体内其它位置的动脉，例如外周动脉。
以下根据本发明的其中一实施例说明一种用于递送植入物的方法。
图2示出了所述销元件41的远端与近端推动器脱离的示意图；图3示出了支架被完全释放的示意图。
如图2和图3所示，该方法大体包括如下步骤：
(1)将所述接合组件和支架11装载进所述导管13中并经由所述导管13递送至中空解剖结构的指定位置(即病变部位)附近。
在该步骤中，当支架11在所述导管13内递送时，通过操作递送管和导丝使接合组件保持夹持状态，支架11的近端端部夹固在销头和近端推动器的腔室之间。具体的操作方式是同时推动递送管和导丝，并同时相对递送管回拉导丝，以在递送过程中保持二者的相对静止，从而使接合组件在对支架11进行夹持的同时向远侧推动支架11至指定位置。
(2)当支架11被递送至病变部位时，通过操作递送管和导丝使接合组件处于释放状态以准备释放支架，包括先向近侧拉动导管13，使接合组件伸出导管13，从而使得大部分支架(即支架11中除了近端端部以外的部分)暴露；接着向远端推动导丝，以通过导丝向远端推动所述销元件41的销柄44，使所述销元件41的销头43逐渐离开近端推动器42的腔室，从而销头43的表面和近端推动器42的腔室的表面之间的间隙大于支架11的厚度，这样支架11的近端端部便失去了夹持的力，从而可以释放。
(3)在销头43离开近端推动器42的腔室后，可以进一步判断是否需要调整支架11的位置。如果需要调整支架11的位置或其它情况需要收回支架时，可以回拉导丝，以将所述销元件41的销柄44向近端方向拉，再次将所述销元件41的销头43拉入近端推动器42的腔室内，这样可以使接合组件处于夹持状态，对支架11进行重新夹持，以执行重新捕获和重新定位(Re-capture and re-positioning)。如果可以释放支架11而不需要再调整支架11的位置时，则同时回拉导丝和递送管，以将所述销元件41和近端推动器42同时向近端方向拉，接合组件将仍然保持释放状态，同时，支架11与指定位置处组织(例如，血管壁)的摩擦力使支架11的位置保持不变，近端推动器42的回撤使支架11的近端脱离近端推动器42的腔室，从而使支架11被完全释放。
为了说明的目的，上述描述已经参考了本发明的特定实施例。然而，以上说明性描述并非旨在穷举或将本发明限制为所公开的精确形式。

Claims (16)

  1. 一种用于递送植入物的接合组件，适于在经由导管递送植入物时对所述植入物进行夹持和释放，其特征在于，所述接合组件包括：
    销元件，包括直径由远端向近端逐渐减小的销头；
    近端推动器，所述近端推动器包括适于容纳所述销头的腔室，所述腔室的表面与所述销头的表面间隙配合；所述近端推动器的近端设有开孔；
    其中，所述销元件的近端与所述导管中的第一细长递送件的远端经由所述开孔实现固定连接，所述近端推动器的近端与所述导管中的第二细长递送件的远端固定连接；
    其中，所述销头能够通过所述第一细长递送件与所述第二细长递送件之间的相对运动而相对于所述近端推动器沿所述导管的纵轴方向移动，以使所述销头进入或离开近端推动器的腔室。
  2. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述接合组件包括夹持状态，在所述夹持状态下，所述销头位于近端推动器的腔室内，且所述销头的表面和所述腔室的表面之间的间隙不大于所述植入物的厚度，以使所述植入物的近端端部能够夹固在销头和近端推动器的腔室之间。
  3. 根据权利要求1或2所述的用于递送植入物的接合组件，其特征在于，所述接合组件包括释放状态，在所述释放状态下，所述销头的表面和所述腔室的表面之间的间隙大于所述植入物的厚度，以使所述植入物能够从所述接合组件释放。
  4. 根据权利要求2所述的用于递送植入物的接合组件，其特征在于，在所述夹持状态下，夹固在销头和近端推动器的腔室之间的所述植入物的近端端部的长度占植入物总长度的5％-30％。
  5. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述销头的直径由远端向近端线性减小；或所述销头的直径由远端向近端非线性减小；或所述销头的直径由远端向近端分段线性减小。
  6. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述销头为锥形或截头锥形销头。
  7. 根据权利要求6所述的用于递送植入物的接合组件，其特征在于，所述锥形或截头锥形销头的圆锥面与中轴线的夹角不超过30度。
  8. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述第一细长递送件为导丝，所述第二细长递送件为套设在导丝上的管状构件。
  9. 根据权利要求8所述的用于递送植入物的接合组件，其特征在于，所述管状构件为海波管。
  10. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述销元件的近端与所述第一细长递送件以焊接、粘接、铰接和/或卡接的方式固定连接，且所述近端推动器的近端与所述第二细长递送件以焊接、粘接、铰接和/或卡接的方式固定连接。
  11. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述销元件还包括与所述销头相连的销柄，所述销头经由所述销柄与所述第一细长递送件固定连接；所述开孔与所述销柄间隙配合。
  12. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述近端推动器具有圆柱形外表面；所述销头的最远端的直径小于所述近端推动器的圆柱形外表面的直径。
  13. 根据权利要求1所述的用于递送植入物的接合组件，其特征在于，所述开孔的直径小于所述销头的最近端的直径。
  14. 一种用于递送植入物的芯组件，其特征在于，包括根据权利要求1-13中任一者所述的用于递送植入物的接合组件，还包括：所述第一细长递送件和所述第二细长递送件。
  15. 一种用于递送植入物的系统，其特征在于，包括根据权利要求14所述的用于递送植入物的芯组件，还包括所述导管和所述植入物。
  16. 一种用于递送植入物的方法，其特征在于，使用根据权利要求1- 13中任一者所述的用于递送植入物的接合组件，所述方法包括：
    推动所述第一细长递送件和所述第二细长递送件，同时相对于所述第二细长递送件回拉所述第一细长递送件，以在导管内将所述接合组件和植入物递送至中空解剖结构的指定位置，且使所述植入物的近端端部夹固在销头和近端推动器的腔室之间；
    在植入物到达所述指定位置后，向近侧拉动导管，使接合组件和植入物伸出所述导管；
    推动所述第一细长递送件，使销头离开推动器的腔室，并判断是否需要调整植入物的位置：
    若需要调整植入物的位置，则回拉所述第一细长递送件，使销头重新进入近端推动器的腔室内，以使所述接合组件重新夹持所述植入物；
    若无需调整植入物的位置，则回拉所述第一细长递送件和第二细长递送件，以释放植入物并撤回所述接合组件。
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