WO2020259640A1 - 血管植入物、输送装置及医疗设备 - Google Patents

血管植入物、输送装置及医疗设备 Download PDF

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Publication number
WO2020259640A1
WO2020259640A1 PCT/CN2020/098312 CN2020098312W WO2020259640A1 WO 2020259640 A1 WO2020259640 A1 WO 2020259640A1 CN 2020098312 W CN2020098312 W CN 2020098312W WO 2020259640 A1 WO2020259640 A1 WO 2020259640A1
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WIPO (PCT)
Prior art keywords
vascular implant
delivery
rod
chamber
proximal end
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PCT/CN2020/098312
Other languages
English (en)
French (fr)
Inventor
赵涵饴
�田�浩
彭晴
王芹芬
Original Assignee
微创神通医疗科技(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 微创神通医疗科技(上海)有限公司 filed Critical 微创神通医疗科技(上海)有限公司
Priority to US17/617,884 priority Critical patent/US20220304838A1/en
Priority to EP20832249.5A priority patent/EP3991699A4/en
Priority to JP2021577344A priority patent/JP2022539145A/ja
Priority to KR1020227001172A priority patent/KR20220024524A/ko
Priority to BR112021024188A priority patent/BR112021024188A2/pt
Priority to CA3143858A priority patent/CA3143858A1/en
Publication of WO2020259640A1 publication Critical patent/WO2020259640A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the technical field of medical equipment, in particular to a vascular implant, a delivery device and medical equipment.
  • Minimally invasive intervention is a treatment method for vascular aneurysms, which usually involves the delivery of vascular implants, such as but not limited to stents, coils, aneurysm blocking devices, etc., to the diseased location through a delivery device.
  • the delivery device includes a delivery rod.
  • the delivery rod is matched with the vascular implant and placed in the delivery sheath together, and then the delivery rod pushes the vascular implant in the delivery sheath to realize the release of the vascular implant.
  • the vascular implant is usually delivered in the delivery sheath through static friction between the vascular implant and the delivery rod, that is, the vascular implant is crimped and sheathed outside the delivery rod, and there is no mechanical connection between the two It moves in the delivery sheath as a whole.
  • the frictional force is more difficult to control, and it is easy to cause unloading of the vascular implant (that is, the vascular implant falls off the delivery rod), so that the vascular implant cannot be stably delivered, which affects the operation effect.
  • the purpose of the present invention is to provide a vascular implant, a delivery device, and a medical device, which aim to keep the vascular implant and the delivery rod relatively stationary in the axial direction during the delivery process, thereby avoiding the occurrence of vascular implants.
  • the problem of unloading improves the stability of delivery of vascular implants.
  • the present invention provides a vascular implant that is delivered to a target location by a delivery device, the delivery device includes a delivery rod and a chamber; wherein the vascular implant has a proximal end, and the proximal The end includes a first connecting portion, the first connecting portion is used to detachably snap-connect to the delivery rod, and the first connecting portion and the delivery rod can be accommodated in the chamber or separated from the Chamber;
  • the first connecting part and the conveying rod are accommodated in the chamber, the first connecting part is held in an engaged state with the conveying rod under the restraining force of the chamber to realize the Axial locking between the vascular implant and the delivery rod;
  • the first connecting part When the first connecting part is separated from the chamber, the first connecting part is released from the constraining force of the chamber and is in a separable state from the delivery rod to realize the vascular implant and The axial direction between the delivery rods is unlocked.
  • the first connecting portion includes at least one first connecting member, and the first connecting member is configured to interact with the first connecting member when subjected to the restraining force of the chamber.
  • the conveying rod is kept in a locked state, and is in a separable state from the conveying rod when the constraint force of the chamber is released; wherein the first connecting member has a gap;
  • the gap is configured to prohibit the conveying rod from passing through, so that the first connecting member and the conveying rod remain engaged status
  • the gap is configured to allow the conveying rod to pass through, so that the first connecting piece and the conveying rod are in a separable state.
  • the first connecting member includes more than two fasteners, and the two or more fasteners are arranged at intervals along the circumferential direction of the vascular implant, And the gap is formed between two or more fasteners.
  • the fastener is configured to be deformable in the axial direction of the vascular implant, so that the first connector is implanted in the blood vessel The object can be deformed in the axial direction.
  • At least one of the two or more fasteners is made of a metal developing material.
  • the first connecting portion includes more than two first connecting members, and the two or more first connecting members are along the axial direction of the vascular implant Interval settings.
  • two or more of the fasteners of the first connecting member are aligned and arranged in the axial direction of the vascular implant.
  • the first connection portion includes more than two first connection groups, and the two or more first connection groups are arranged at intervals along the axial direction of the vascular implant ;
  • Each of the first connecting groups includes two or more first connecting members, and the first connecting members in each of the first connecting groups are arranged at intervals along the axial direction of the vascular implant;
  • the fasteners in the same first connection group are aligned in the axial direction of the vascular implant, and the fasteners in different first connection groups are arranged on the axis of the vascular implant Stagger the arrangement upwards.
  • the vascular implant is a self-expanding implant.
  • the blood vessel implant is a stent, a coil or an aneurysm blocking device.
  • the present invention also provides a delivery device for delivering a vascular implant to a target location, including:
  • a delivery rod the delivery rod includes a second connecting portion for detachably snap-connecting with the proximal end of the vascular implant;
  • the proximal end of the vascular implant and the delivery rod When the proximal end of the vascular implant and the delivery rod are accommodated in the chamber, the proximal end of the vascular implant receives the restraining force of the chamber and keeps the second connecting portion locked. Closed state to achieve axial locking between the vascular implant and the delivery rod;
  • the proximal end of the vascular implant When the proximal end of the vascular implant is separated from the chamber, the proximal end of the vascular implant is released from the constraining force of the chamber and is in a separable state from the second connecting portion to The axial unlocking between the vascular implant and the delivery rod is realized.
  • the second connecting portion includes at least one second connecting member for detachably snap-connecting to the proximal end of the vascular implant;
  • the delivery rod also includes a rod body, and at least one protrusion is formed on the rod body, and the protrusion is the second connecting member, so that the proximal end of the vascular implant is engaged with The two sides of at least one of the convex portions or are engaged between at least two of the convex portions.
  • the second connecting portion includes at least one second connecting member for detachably snap-connecting to the proximal end of the vascular implant;
  • the delivery rod further includes a rod body, and at least one recess is formed on the rod body, and the recess is the second connecting part so that the proximal end of the vascular implant is engaged with the In the recess.
  • the second connector has an axially penetrating surface groove for accommodating part of the vascular implant.
  • the proximal end of the vascular implant includes at least one first connector, and the first connector is used for detachably snap-connecting to the second connector, and the first connector Comprising more than two fasteners, the two or more fasteners are arranged at intervals along the circumferential direction of the vascular implant, and a gap is formed between the two or more fasteners;
  • the surface groove is configured to prohibit the buckle from passing through.
  • the second connecting portion is made of a metal developing material.
  • the conveying device further includes a restraining member, and the restraining member includes the chamber and is arranged outside the conveying rod.
  • the delivery device further includes a delivery sheath for loading the vascular implant, and the delivery rod is used to movably insert the delivery sheath, and The delivery sheath constitutes the restriction member.
  • the delivery device further includes a delivery sheath for loading the vascular implant, and the delivery rod is used to movably insert the delivery sheath;
  • the restriction member is used to movably insert the delivery sheath to wrap the proximal end of the vascular implant and the delivery rod.
  • the present invention provides a medical device, including: any one of the vascular implants; and any one of the delivery devices;
  • the first connecting part of the vascular implant is used for detachably snap-connecting with the second connecting part of the delivery rod.
  • vascular implant, delivery device and medical equipment provided by the present invention have the following advantages:
  • the proximal end of the above-mentioned vascular implant and the delivery rod of the delivery device are detachably snapped and connected, so that the vascular implant and the delivery rod are relatively stationary in the axial direction during the delivery process. Therefore, the vascular implant is not prone to unloading problems, so that the vascular implant can be stably delivered, thereby reducing the difficulty of the operation, and improving the safety of the operation and the treatment effect.
  • the above-mentioned medical equipment realizes the axial locking and unlocking between the vascular implant and the delivery rod by means of the chamber of the delivery device, which not only facilitates the locking and unlocking operation, but also helps to reduce the difficulty of the operation and improve the efficiency of the operation.
  • the reliability of the joint connection is high, and the axial locking between the vascular implant and the delivery rod can be better realized.
  • the proximal end of the above-mentioned vascular implant preferably includes two or more first connection groups, and the two or more first connection groups are arranged at intervals along the axial direction of the vascular implant, and are different in the first connection group
  • the fasteners are staggered in the axial direction of the vascular implant, which can compress the fasteners in different axial directions on different circumferences, thereby reducing the compression size of the vascular implant and its delivery device, Enables vascular implants to be delivered in smaller delivery devices.
  • the above-mentioned delivery device preferably includes a restraint, and the restraint provides a chamber, and the restraint is preferably movably inserted into the delivery sheath, so as to restrain the first connection part of the proximal end of the vascular implant.
  • the full release and full recovery of the vascular implant can be achieved. For example, after pushing all the vascular implant and its delivery rod out of the delivery tube sheath, the vascular implant is fully released at the target position. At this time, the vascular implant and the delivery rod are still not separated, which can realize the vascular implant Of recycling again.
  • the restraint member and the delivery rod move relative to each other, so that the restraint imposed by the restraint member is released, and the vascular implant and the delivery rod are separated, thereby realizing release.
  • This arrangement can improve the accuracy of the release of the vascular implant in the body, thereby improving the treatment effect.
  • Figure 1 is a schematic structural view of a self-expanding braided stent according to an embodiment of the present invention
  • Figure 2a is a schematic structural diagram of a self-expanding braided stent according to an embodiment of the present invention, where the proximal end of the self-expanding braided stent is welded and formed into a fastener;
  • Fig. 2b is an enlarged schematic diagram of a fastener on the proximal end of a self-expanding braided stent according to an embodiment of the present invention
  • 3a to 3d are respectively structural schematic diagrams of a second connecting member according to an embodiment of the present invention.
  • FIG. 4 is a schematic structural diagram of the conveying rod according to the first embodiment of the present invention, wherein the conveying rod includes two second connecting parts;
  • FIG. 5 is a schematic diagram of the connection between the delivery device and the self-expanding braided stent according to the first embodiment of the present invention
  • Fig. 6a is a schematic diagram of a gap formed by the first connecting member in the first embodiment of the present invention.
  • FIG. 6b is a schematic diagram of the maximum diameter of the second connecting member being larger than the gap on the first connecting member according to the first embodiment of the present invention
  • Fig. 7 is an enlarged schematic view of the proximal snap member of the self-expanding braided stent according to the second embodiment of the present invention.
  • Figure 8 is a schematic structural diagram of the delivery rod of the second embodiment of the present invention, wherein the delivery rod includes a second connecting piece;
  • FIG. 9 is a schematic diagram of the snap connection between the first connecting piece and the second connecting piece according to the second embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the connection between the delivery device and the self-expanding braided stent according to the second embodiment of the present invention, wherein the proximal end of the self-expanding braided stent has not been separated from the delivery sheath;
  • Fig. 11 is an enlarged schematic diagram of a fastener at the proximal end of the self-expanding braided stent according to the third embodiment of the present invention.
  • Figure 12 is a schematic diagram of the connection between the delivery device of the third embodiment of the present invention and the self-expanding braided stent, wherein the proximal end of the self-expanding braided stent has not been separated from the delivery sheath;
  • Fig. 13 is an enlarged schematic view of the self-expanding braided stent shown in Fig. 12 and the delivery rod engaged and connected;
  • FIG. 14 is a schematic diagram of the connection between the delivery device of the fourth embodiment of the present invention and the self-expanding braided stent, wherein the proximal end of the self-expanding braided stent is not separated from the release restraint tube.
  • distal and proximal are used; “proximal” is the end close to the medical device operator; “distal” is the end far away from the medical device operator.
  • distal is the end far away from the medical device operator.
  • the core idea of the present invention is to provide a medical device including a vascular implant and a delivery device; the vascular implant is delivered to a target location by the delivery device, and the delivery device includes a delivery rod and a chamber.
  • the vascular implant of the present invention has a proximal end, and the proximal end includes a first connecting portion.
  • the conveying rod includes a second connecting portion.
  • the first connecting portion is used for detachably snap-connecting to the second connecting portion, so that the vascular implant and the delivery rod remain relatively stationary in the axial direction.
  • the first connecting portion and the delivery rod are used to be accommodated in the chamber.
  • the first connecting portion receives the restraining force of the chamber and maintains the engaged state with the second connecting portion, thereby achieving The axial locking between the vascular implant and the delivery rod.
  • the first connecting part is separated from the chamber, the first connecting part is released from the restriction of the chamber and is in a separable state from the second connecting part, and finally realizes the blood vessel The axial direction between the implant and the delivery rod is unlocked.
  • the vascular implant and the delivery rod realize a detachable mechanical connection, so that during the delivery process, the problem of unloading of the vascular implant can be avoided, so that the vascular implant can be stably delivered. Reduce the difficulty of the operation, improve the safety of the operation and the treatment effect.
  • the conveying device further includes a restraining member, and the restraining member includes the cavity, and the restraining member is configured to be disposed outside the conveying rod.
  • the delivery device further includes a delivery sheath for loading a vascular implant, the delivery rod can be movably inserted into the delivery sheath, and the delivery sheath constitutes the restriction member.
  • the constraining member is a restraint release tube, which is movably inserted into the delivery sheath and sleeved on the outside of the delivery rod to wrap the first connecting portion and the delivery rod.
  • the first connecting part may include one or more than two first connecting parts, and one or more than two first connecting parts are used for detachably snap-connecting to the second connecting part.
  • the second connecting part may include one or more than two second connecting parts, and the one or more second connecting parts are used to detachably connect with the first connecting part.
  • the main ways to form a snap connection are:
  • the above-mentioned methods for forming a snap connection can be used in combination or alone, and are not limited to only a pair of snap connections, and more than two snap connections can also be provided to form a more reliable connection.
  • the vascular implant is mainly an implant used for the treatment of vascular aneurysms, such as stents, coils or aneurysm blocking devices, etc., and can also be used for vasodilation, vascular embolization capture or other lumens Treatment of disease.
  • the delivery process of the vascular implant of the present invention specifically includes the following steps:
  • the first is the loading of the vascular implant: the vascular implant is set on the outside of the delivery rod, and then the vascular implant and the delivery rod are loaded into the delivery sheath. At this time, the radial constraint of the delivery sheath Next, the first connecting portion and the second connecting portion are kept in a snapped state to realize the axial locking between the vascular implant and the delivery rod;
  • the delivery rod is used to push the vascular implant, so that the entire (including the proximal end) of the vascular implant is separated from the delivery sheath. Since the radial constraint from the delivery sheath is released, the vascular implant is The implant is expanded (or called swelling), so that the first connecting portion is separated from the second connecting portion and the engagement is released, thereby realizing the release of the vascular implant in the body.
  • the expansion method of the vascular implant after being separated from the delivery sheath can be self-expansion or passive expansion.
  • the “self-expanding” refers to the self-expanding property of the vascular implant, which can expand or unfold after the external force constraint is released;
  • the “passive expansion” refers to the implantation of the blood vessel by means of an external mechanism, such as an expansion balloon The object expands or unfolds after the external force is released.
  • the restraint is a restraint release tube, which can be movably inserted into the delivery sheath and sheathed outside the delivery rod.
  • the restraint release tube can also be used to achieve full vascular implants. Release and full recovery. The operation process will be explained in detail in the following description. This is convenient for observing the position and state of the implant after the implantation is released, and re-adjusting the implantation position as needed, thereby improving the accuracy of the release of the vascular implant in the body and improving the treatment effect.
  • vascular implant and delivery device proposed by the present invention will be further described below with reference to the accompanying drawings and several embodiments. And in the following, it is assumed that the vascular implant is a stent, but those skilled in the art should be able to modify the following description to apply it to the case where it is not a stent.
  • the vascular implant can be a stent 1.
  • the stent 1 can be one or a combination of a cutting stent and a braided stent, and the stent 1 can be a self-expanding stent or a passively expanding stent.
  • the cutting stent can be made of shape memory material or elastic material, including but not limited to Nitinol.
  • the braided stent can be braided by braided wires made of metal or polymer materials, including but not limited to Nitinol, stainless steel or polymer.
  • the self-expanding braided stent is mainly used as an example for description, but those skilled in the art should also be able to modify the following description to apply it to the case of a self-expanding braided stent.
  • the stent 1 has a proximal end 11 and a distal end 12 opposite to each other.
  • the proximal end 11 of the stent 1 can be formed by binding a single strand or two or more braided wires together, or can be formed by re-knitting a single wire, which is not specifically limited in the present invention.
  • the binding method of the braided wire can be, but not limited to, twisting, cementing, welding, etc.
  • two adjacent braided wires S1 and S2 at the proximal end 11 can be braided and welded together, and welding points Q can be formed at multiple locations.
  • a single braided wire S1 or S2 and/or two braided wires S1 and S2 can be further wound to form a spiral-shaped fastener 13.
  • the proximal end 11 of the stent 1 can also be additionally wound with external wires to form a spiral-shaped fastener 13.
  • a tubular fastener 13 can be directly sleeved on the proximal end 11 to cover the braided wires bound together.
  • the present invention does not impose any special restrictions on the arrangement of the fastener 13 at the proximal end of the bracket 1.
  • the fastener 13 may be a hollow tubular structure, including but not limited to a spiral form.
  • the fastener 13 may also be a solid member, for example, a solid cylinder is directly connected to the proximal ends of two braided wires welded together to form the fastener 13. Therefore, the present invention does not impose special restrictions on the structure of the fastener 13, as long as it is convenient to realize the connection between the braided wire and the fastener.
  • the fastener 13 is preferably tubular and wrapped with braided wire, and the tubular shape is more preferably spiral to provide elasticity.
  • the fastener 13 can be made of polymer materials or metal materials, including but not limited to stainless steel, nickel-titanium alloy, etc., preferably, the fastener 13 is made of a radiopaque metal developing material to facilitate the implantation process Observe the specific position of the proximal end 11 of the stent 1.
  • the proximal end 11 of the stent 1 includes a first connecting portion, and the first connecting portion includes at least one first connecting member 2 (see FIG. 6a).
  • the first connecting member 2 is configured to When the restraining force of the chamber is engaged with the conveying rod, it is in a separable state from the conveying rod when the restraining force of the chamber is released.
  • the first connecting member 2 includes two or more fasteners 13, and the two or more fasteners 13 are arranged symmetrically around the axis of the bracket 1 (that is, symmetrically arranged along the circumferential direction of the bracket 1, or centrally symmetrically arranged).
  • a gap is formed between two or more fasteners 13 (as indicated by d1 in FIG. 6a).
  • the size of the gap can be switched between a larger size and a smaller size, mainly related to the compression and expansion of the stent.
  • the delivery sheath as an example, before the stent 1 is loaded into the delivery sheath, since the stent 1 is not compressed in the radial direction, the size of the gap is larger, making the delivery rod
  • the second connecting member 3 can pass through the gap, thereby facilitating the loading of the bracket 1 on the conveying rod.
  • the size of the gap is reduced due to the compression of the stent 1 by the constraining force of the chamber, so that the second connector 3 of the delivery rod cannot The axial direction passes through the gap at this time.
  • the maximum size (for example, diameter) of the gap at this time is smaller than the size (for example, diameter) of the second connector 3, so as to ensure the first connector 2 and the delivery rod at the proximal end of the stent
  • the second connecting member 3 at the distal end is kept in a snapped state without being separated, thereby realizing the axial locking between the delivery rod and the stent 1, and further enabling the delivery of the stent 1 in the delivery sheath through the delivery rod.
  • the restraining force of the chamber is released, the stent 1 is released and expanded, and the first connecting member 2 can be separated from the second connecting member 3, realizing the axial unlocking between the conveying rod and the stent 1.
  • the conveying device includes a conveying rod 4, the conveying rod 4 includes a second connecting part, and the second connecting part includes at least one second connecting member 3.
  • the delivery rod 4 further includes a rod body on which at least one second connecting member 3 is formed.
  • at least one convex portion is formed on the rod body, and the convex portion constitutes the second connecting member 3, so that the at least one first connecting member 2 can be engaged between at least two convex portions. Between, or at least two second connecting members 3 can be clamped on opposite sides of at least one convex portion.
  • at least one recess is formed on the rod body, and the recess constitutes the second connecting member 3, so that the at least one first connecting member 2 can be locked in the at least one recess.
  • the second connecting member 3 is a convex portion to further illustrate that it is easy to realize the snap connection between the first connecting portion and the second connecting portion.
  • those skilled in the art should be able to modify the following description to apply it to The convex part.
  • each buckle 13 laps on the second connecting piece 3 to form a snap connection and is bound by the delivery sheath and cannot be released.
  • This snap-in physical connection can provide more stable transportation.
  • the buckle 13 is pushed out of the delivery sheath, the restraint from the delivery sheath is released, so that the buckle 13 is released from the second connecting piece 3.
  • This release method is also very convenient and fast, and the structure is simple. The stent 1 can be quickly released.
  • the stent 1 is transported in the delivery sheath through the mechanical connection with the delivery rod. This makes the stent 1 not easy to fall off during the delivery process, thereby improving the stability of stent delivery. Moreover, the structure of the snap connection is simple, and the locking and unlocking are also convenient.
  • the second connecting member 3 has axially penetrating surface grooves, but the surface grooves can be formed by the notches shown in Figure 3b or Figure 3c, or by The adjacent protrusions shown in 3a are defined.
  • the second connecting member 3 may also be a cylinder with a smooth surface, but the shape of the cross-section of the cylinder is not limited, and may be a circle, a square, a rectangle or a special shape.
  • the second connecting member 3 may be a solid member or a tubular member, and the tubular member may also be a spiral type.
  • the second connecting member 3 can be made of polymer materials or metal materials, including but not limited to stainless steel, nickel-titanium alloy, etc.
  • the second connecting member 3 is made of a radiopaque metal developing material for implantation During the process, observe its position and its axial relative position with the delivery sheath to determine the release state of the stent 1.
  • the surface grooves are more than two and are arranged around the axis of the second connecting member 3 (that is, arranged at intervals along the circumferential direction of the second connecting member 3, and more preferably arranged symmetrically along the circumferential direction of the second connecting member 3) . Furthermore, through the surface groove on the second connecting member 3, a part of the braided wire of the proximal end 11 of the stent 1 can be accommodated in the surface groove when it is engaged. On the one hand, the compressed diameter of the stent 1 can be reduced, thereby By reducing the diameter of the delivery sheath, on the other hand, the stent 1 and the delivery rod can be further restrained, thereby further improving the stability of stent delivery.
  • the proximal end 11 of the stent 1 includes a number of grids, of which a fastener 13 is provided on the end of at least part of the grid, that is, it is not necessary to provide a fastener 13 on all the grids at the proximal end of the stent, but one
  • the first connector 2 includes two or more fasteners 13 on different grids, and the fasteners 13 in each first connector 2 are symmetrically arranged on the same circumference.
  • first connecting member 2 and the second connecting member 3 form a snap connection
  • the conveying rod 4 includes a second connecting portion, and the second connecting portion includes at least two second connecting members 3, and at least two second connecting members 3 are on the shaft of the rod body. Set up at intervals. Assuming that there are two second connecting members 3, the axial distance of the two second connecting members 3 is configured to allow at least one first connecting member 2 to be engaged. Since the first connecting piece 2 can be a resilient member, it can be compressed between the two second connecting pieces 3, so the axial distance between the two second connecting pieces 3 can be less than or equal to the first connecting piece 2 The axial length (that is, the length before compression). However, the first connecting member 2 may also be a rigid member with no elasticity, that is, non-deformable.
  • the axial distance between the two second connecting members 3 may be greater than or equal to the axial length of the first connecting member 2, and In order to avoid a large displacement in the axial direction, the gap between the two second connecting members 3 and the first connecting member 2 should not be too large.
  • the second connecting member 3 can also be a resilient member, which is convenient for engaging a first connecting member 2 through deformation. Therefore, the axial distance between the two second connecting members 3 can also be less than or equal to the first connecting member 2. The axial length.
  • the first connecting member 2 includes four fasteners 13 arranged at intervals on the same circumference, and each fastener 13 is provided on the braided wire of the proximal end 11 of the stent 1. Above, and the structure of the fasteners 13 may be the same or different, and the two ends may be aligned or not.
  • the delivery device also includes a delivery sheath 5. In actual operation, as shown in FIG.
  • the entire stent 1 is compressed, so that the four fasteners 13 at the proximal end 11 are also compressed to be engaged between the two second connectors 3 , That is, one of the second connector 3 is snapped to the proximal end of the first connector 2, and the other second connector 3 is snapped to the distal end of the first connector 2, so that it prevents Movement of bracket 1.
  • the surface groove is formed on the outer surface of the second connector 3, so that the braided wire of the proximal end 11 of the stent 1 is connected as a whole and then embedded in the surface groove of the second connector 3 at the distal end. Therefore, the structures of the two second connecting members 3 may be different or the same, wherein one of the second connecting members 3 preferably located at the distal end is provided with a surface groove, and the other is not provided with a surface groove.
  • a gap is formed between the four fasteners 13 (that is, the d1 mark in the figure);
  • the gap is a regular pattern, for example, a circle
  • the diameter d2 for example, the maximum size
  • the diameter d2 of the second connecting member 3 It needs to be larger than the maximum size of the gap; this can ensure that the second connector 3 will not slip out of the gap when it is pushed.
  • the radial distance L1 of the surface groove may be equal to or greater than the radial distance of the gap (d1/2), the radial distance of the surface groove L1 can also be smaller than the radial distance (d1/2) of the gap, that is, the depth of the surface groove is not particularly limited.
  • the size of the surface groove is preferably configured to prohibit the fastener 13 from passing through, and it is preferable to set the surface groove along the largest circumferential direction of the second connector 3 The size is designed to be smaller than the minimum size of the fastener 13 in the circumferential direction of the bracket 1.
  • the second connecting portion of the delivery rod 4 includes at least one second connecting member 3, and the first connecting portion of the proximal end 11 of the stent 1 includes at least two A connecting piece 2, at least two first connecting pieces 2 are arranged at an axial interval at the proximal end of the stent 1.
  • the axial distance between the two first connectors 2 is configured to allow at least one second connector 3 to be engaged.
  • the axial distance between the two first connecting members 2 may be greater than the axial length of the second connecting member 3, and may also be less than or equal to the axial length of the second connecting member 3.
  • the first connecting member 2 is an elastic member , Can be stretched or compressed.
  • the first connection portion at the proximal end of the stent includes more than two first connection groups, and the two or more first connection groups are arranged at intervals along the axial direction of the stent 1, and each first connection group includes two
  • first connecting member 2 two or more first connecting members 2 in each of the first connecting groups are arranged at intervals along the axial direction of the bracket 1, and the buckle members 13 in the same first connecting group are in the bracket 1
  • the axis is aligned up.
  • the axial upward alignment means that the axial projections of the fasteners 13 in the same first connection group are coincident on the same projection plane perpendicular to the axis of the bracket.
  • the fasteners 13 in different first connection groups are staggered in the axial direction of the stent 1, so that the fasteners 13 in different first connection groups can be compressed on different circumferences, thereby reducing
  • the small compressed size further reduces the size of the delivery sheath 5, which facilitates the delivery of the stent 1 in a smaller delivery sheath.
  • the number of the first connection groups is two, which are the first connection groups 14 and 15, respectively.
  • the two first connections are defined by dotted lines in the figure.
  • the first connection groups 14 and 15 are arranged at intervals along the axial direction of the stent 1, and the fasteners 13 in the first connection groups 14 and 15 are staggered in the axial direction.
  • the staggered axial direction means that the axial projections of the fasteners 13 in the first connection groups 14 and 15 do not coincide on the same projection plane perpendicular to the axis of the bracket.
  • the first connecting group 14 includes two first connecting members 2 arranged in sequence from far to near, the two first connecting members 2 are spaced apart along the axial direction of the stent 1, and the two first connecting members The fasteners 13 of 2 are aligned in the axial direction.
  • the first connecting group 15 includes two first connecting members 2 arranged in sequence from far to near. The two first connecting members 2 are also spaced apart along the axial direction of the stent 1, and the two first connecting members The fasteners 13 of 2 are aligned in the axial direction.
  • each first connecting member 2 as a schematic diagram including two buckle members 13, as shown in FIG. 11, from far to near, the first, second, third, and The fourth first connecting piece 2, the two buckling pieces 13 in the first first connecting piece 2 at the far end and the two buckling pieces 13 in the adjacent second first connecting piece 2 Aligned in the axial direction, and the third first connecting piece 2 and the nearest fourth first connecting piece 2 are also arranged as the first two first connecting pieces 2, but the latter two first connecting pieces 2
  • the buckle 13 is offset from the buckles 13 of the first two first connecting members 2 in the axial direction.
  • the axial position of the buckle 13 is different in the circumferential direction (that is, the axial position is staggered), so that the size of the stent 1 compressed in the delivery sheath 5 will be smaller, so that the stent 1 can be more Delivery in a small delivery sheath.
  • the conveying rod 4 includes two second connecting members 3, which are respectively snap-connected to the two first connecting groups 14 and 15. As shown in Figures 12 and 13, a second connector 3 is provided between the two first connectors 2 at the proximal end, and another second connector is provided between the two first connectors 2 at the distal end. 3. This restricts the relative position between the stent 1 and the delivery rod 4, thereby realizing a stable and reliable connection while reducing the size.
  • the structure of the stent and the delivery device of this embodiment is basically the same as that of the foregoing embodiment, and only the differences are described below.
  • the delivery device further includes a restraint release tube 6, which is movably arranged inside the delivery sheath 5 and sleeved outside the delivery rod 4, so as to realize the completeness of the stent 1. Release and full recovery.
  • the restraining release tube 6 constitutes the restraining member.
  • the stent 1 is fully released at the target position. At this time, the proximal end 11 of the stent and the delivery rod 4 are still not separated. If the ideal disengagement state has not been reached (for example, the stent is not completely Release or release), the stent 1 can still be fully or partially recovered into the delivery sheath 5 by retracting the delivery rod 4.
  • the release restraint tube 6 moves relative to the delivery rod 4, for example, the operator operates the delivery rod 4 to move forward (toward the distal end) while keeping the release restraint tube 6 still , Or the restraint release tube 6 is withdrawn but the delivery rod 4 does not move, so that the restraint imposed by the restraint release tube 6 on the proximal end 11 of the stent 1 is released, and the stent 1 is separated from the delivery rod 4, thereby achieving release.
  • the present invention can be fully recovered after the stent 1 (except the proximal end 11) is fully released, until the desired release position and release state are reached, and then the proximal end 11 of the stent 1 is connected to the delivery rod. 4 Release, this setting can improve the accuracy of the release of the stent 1 in the body, thereby improving the treatment effect.
  • the restraint release tube 6 wraps the second connection piece 3 and the first connection piece 2, so that the second connection piece 3 and the first connection piece 2 remain in the engaged state.
  • the transfer rod 4 and the restraint release pipe 6 are between the When there is no relative displacement, the bracket 1 and the conveying rod 4 are in a snap connection.
  • the restraint release tube 6 moves proximally relative to the delivery rod 4, the proximal end 11 of the stent 1 and the second connector 3 lose their restraint radially, and the stent 1 itself has the characteristic of self-expansion, so the proximal end 11 of the stent 1 changes from The second connecting piece 3 springs apart in the radial direction, and the proximal end 11 of the stent 1 is separated from the delivery rod 4, thereby being released.
  • the distal end of the restraint release tube 6 extends to the proximal end 11 of the stent 1, as long as the first connector 2 can be restrained, and the proximal end of the restraint release tube 6 extends out of the proximal end of the delivery sheath 5. It is convenient for the surgeon to operate.
  • the material of the restraint release tube 6 is not limited, and may be a polymer material or a metal material.
  • the locking member 13 when a second connecting member 3 is engaged between two first connecting members 2, while the two first connecting members 2 are arranged at an axial interval, the locking member 13 can be The arrangement is aligned in the axial direction, and the arrangement can also be staggered in the axial direction. If the arrangement is staggered in the axial direction, it is beneficial to reduce the compression size.
  • the present invention includes but is not limited to the connection methods listed in the above embodiments, and any content that is changed on the basis of the connection methods provided in the above embodiments is applicable. It belongs to the protection scope of the present invention. Those skilled in the art can draw inferences based on the content of the foregoing embodiments.

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Abstract

一种血管植入物、输送装置及医疗设备,在输送过程中使血管植入物和输送杆(4)在轴向上保持相对静止,从而避免血管植入物发生脱载的问题,提高血管植入物输送的稳定性。血管植入物包括第一连接部,输送装置包括输送杆(4)和腔室,输送杆(4)包括第二连接部,第一连接部用于与第二连接部可分离地卡合连接,且第一连接部和输送杆(4)用于容纳于腔室中。当第一连接部和输送杆(4)容纳于腔室时,第一连接部受到腔室的约束而与第二连接部保持卡合的状态,以实现血管植入物与输送杆(4)间的轴向锁定;当第一连接部脱离腔室时,第一连接部被解除腔室的约束而与第二连接部处于可分离的状态,以实现血管植入物与输送杆(4)间的轴向解锁。

Description

血管植入物、输送装置及医疗设备 技术领域
本发明涉及医疗器械技术领域,特别涉及一种血管植入物、输送装置及医疗设备。
背景技术
微创伤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、动脉瘤封堵装置等,通过输送装置输送至病变位置。输送装置包括输送杆,实际输送时,输送杆与血管植入物相配合且一起置于输送鞘管中,进而输送杆在输送鞘管内推送血管植入物,实现血管植入物的释放。
在现有技术中,血管植入物通常通过与输送杆之间的静摩擦力实现在输送鞘管中的输送,即血管植入物压握后套于输送杆的外部,两者并无机械连接而作为整体在输送鞘管中运动。但实际操作时,摩擦力的大小较难控制,容易造成血管植入物的脱载(即血管植入物从输送杆上脱落),使血管植入物不能够被稳定地输送,从而影响手术效果。
发明内容
为此,本发明的目的在于提供一种血管植入物、输送装置以及医疗设备,旨在输送过程中使血管植入物和输送杆在轴向上保持相对静止,从而避免血管植入物发生脱载的问题,提高血管植入物输送的稳定性。
为实现上述目的,本发明提供了一种血管植入物,通过输送装置递送至目标位置,所述输送装置包括输送杆和腔室;其中所述血管植入物具有近端,且所述近端包括第一连接部,所述第一连接部用于与所述输送杆可分离地卡合连接,且所述第一连接部和所述输送杆能够容纳于所述腔室或者脱离所述腔室;
当所述第一连接部和所述输送杆容纳于所述腔室时,所述第一连接部受到所述腔室的约束力而与所述输送杆保持卡合的状态,以实现所述血管植入 物与所述输送杆间的轴向锁定;
当所述第一连接部脱离所述腔室时,所述第一连接部被解除所述腔室的约束力而与所述输送杆处于可分离的状态,以实现所述血管植入物与所述输送杆间的轴向解锁。
可选地,在所述的血管植入物中,所述第一连接部包括至少一个第一连接件,所述第一连接件被配置为,在受到所述腔室的约束力时与所述输送杆保持卡合的状态,并在解除所述腔室的约束力时与所述输送杆处于可分离的状态;其中,所述第一连接件具有空隙;
当所述第一连接部和所述输送杆容纳于所述腔室时,所述空隙被配置为禁止所述输送杆通过,以使所述第一连接件和所述输送杆保持卡合的状态;
当所述第一连接部脱离所述腔室时,所述空隙被配置为允许所述输送杆通过,以使所述第一连接件和所述输送杆处于可分离的状态。
可选地,在所述的血管植入物中,所述第一连接件包括两个以上的卡扣件,两个以上所述卡扣件沿所述血管植入物的周向间隔设置,且两个以上所述卡扣件之间形成所述空隙。
可选地,在所述的血管植入物中,所述卡扣件被配置为在所述血管植入物的轴向上能够变形,以使所述第一连接件在所述血管植入物的轴向上能够变形。
可选地,在所述的血管植入物中,所述两个以上的卡扣件中的至少一个由金属显影材料制成。
可选地,在所述的血管植入物中,所述第一连接部包括两个以上所述第一连接件,两个以上所述第一连接件沿所述血管植入物的轴向间隔设置。
可选地,在所述的血管植入物中,两个以上所述第一连接件的所述卡扣件在所述血管植入物的轴向上对齐布置。
可选地,在所述的血管植入物中,所述第一连接部包括两个以上第一连接组,两个以上所述第一连接组沿所述血管植入物的轴向间隔设置;
每个所述第一连接组包括两个以上所述第一连接件,每个所述第一连接组中的所述第一连接件沿所述血管植入物的轴向间隔设置;
其中:同一第一连接组中的所述卡扣件在所述血管植入物的轴向上对齐布置,且不同第一连接组中的所述卡扣件在所述血管植入物的轴向上错开布置。
可选地,在所述的血管植入物中,所述血管植入物为自扩张植入物。
可选地,在所述的血管植入物中,所述血管植入物为支架、弹簧圈或动脉瘤封堵装置。
为实现上述目的,本发明还提供了一种输送装置,用于将血管植入物递送至目标位置,包括:
输送杆,所述输送杆包括第二连接部,所述第二连接部用于与所述血管植入物的近端可分离地卡合连接;以及
腔室,用于容纳所述输送杆和所述血管植入物的近端;
当所述血管植入物的近端和所述输送杆容纳于所述腔室时,所述血管植入物的近端受到所述腔室的约束力而与所述第二连接部保持卡合的状态,以实现所述血管植入物与所述输送杆间的轴向锁定;
当所述血管植入物的近端脱离所述腔室时,所述血管植入物的近端被解除所述腔室的约束力而与所述第二连接部处于可分离的状态,以实现所述血管植入物与所述输送杆间的轴向解锁。
可选地,在所述的输送装置中,所述第二连接部包括至少一个第二连接件,用于与所述血管植入物的近端可分离地卡合连接;
所述输送杆还包括杆件本体,所述杆件本体上形成有至少一个凸部,且所述凸部为所述第二连接件,以使所述血管植入物的近端卡合在至少一个所述凸部的两侧或卡合在至少两个所述凸部之间。
可选地,在所述的输送装置中,所述第二连接部包括至少一个第二连接件,用于与所述血管植入物的近端可分离地卡合连接;
所述输送杆还包括杆件本体,所述杆件本体上形成有至少一个凹部,且所述凹部为所述第二连接件,以使所述血管植入物的近端卡合在所述凹部中。
可选地,在所述的输送装置中,所述第二连接件具有轴向贯通的表面凹槽,用于容纳部分所述血管植入物。
可选地,在所述的输送装置中,所述表面凹槽为两个以上且沿所述第二连接件的周向布置。
可选地,所述血管植入物的近端包括至少一个第一连接件,所述第一连接件用于与所述第二连接件可分离地卡合连接,且所述第一连接件包括两个以上的卡扣件,两个以上所述卡扣件沿所述血管植入物的周向间隔设置,且两个以上所述卡扣件之间形成空隙;
当所述血管植入物的近端和所述输送杆卡合并容纳于所述腔室时,所述表面凹槽被配置为禁止所述卡扣件通过。
可选地,在所述的输送装置中,所述第二连接部由金属显影材料制成。
可选地,在所述的输送装置中,所述输送装置还包括约束件,所述约束件包括所述腔室并设置于所述输送杆的外部。
可选地,在所述的输送装置中,所述输送装置还包括用于装载所述血管植入物的输送鞘管,所述输送杆用于可活动地插入所述输送鞘管,且所述输送鞘管构成所述约束件。
可选地,在所述的输送装置中,所述输送装置还包括用于装载所述血管植入物的输送鞘管,所述输送杆用于可活动地插入所述输送鞘管;所述约束件用于可活动地插入所述输送鞘管,以包裹所述血管植入物的近端和所述输送杆。
为实现上述目的,本发明又提供了一种医疗设备,包括:任一项所述的血管植入物;以及任一项所述的输送装置;
其中,所述血管植入物的第一连接部用于与所述输送杆的第二连接部可分离地卡合连接。
综上,本发明提供的血管植入物、输送装置以及医疗设备具有如下优点:
第一、上述血管植入物的近端与输送装置的输送杆可分离地卡合连接,实现了输送过程中血管植入物和输送杆在轴向上的相对静止,这样做在输送过程中,血管植入物不容易发生脱载问题,从而使血管植入物能够被稳定地输送,以此降低手术操作难度,提高手术操作安全性和治疗效果。
第二、上述医疗设备借助于输送装置的腔室实现了血管植入物和输送杆 间的轴向锁定和解锁,不仅锁定和解脱操作方便,有利于降低手术操作难度,提高手术效率,而且卡合连接的可靠性高,可较好的实现血管植入物和输送杆间的轴向锁定。
第三、上述血管植入物的近端优选包括两个以上第一连接组,两个以上所述第一连接组沿所述血管植入物的轴向间隔设置,且不同第一连接组中的卡扣件在血管植入物的轴向上错开布置,这样做能够使不同轴向上的卡扣件压缩于不同的圆周上,从而减小血管植入物及其输送装置的压缩尺寸,使血管植入物能够在更小的输送装置中输送。
第四、上述输送装置优选包括约束件,且约束件提供一个腔室,且约束件优选可活动地插入输送鞘管,以此实现对血管植入物之近端的第一连接部的束缚,这样做可实现血管植入物的全释放与全回收。例如,将血管植入物及其输送杆全部推离出输送管鞘后,使血管植入物全释放于目标位置,此时血管植入物与输送杆仍未分离,可实现血管植入物的再次回收。而当满足解脱条件时,约束件与输送杆相对移动,使约束件施加的束缚解除,血管植入物与输送杆实现分离,进而实现解脱。这样设置可提高血管植入物在体内释放的准确性,从而改善治疗效果。
附图说明
图1是本发明一实施例的自扩张编织支架的结构示意图;
图2a是本发明一实施例的自扩张编织支架的近端并丝焊接并形成卡扣件的结构示意图;
图2b是本发明一实施例的自扩张编织支架的近端上卡扣件的放大示意图;
图3a-图3d分别是本发明一实施例的第二连接件的结构示意图;
图4为本发明实施例一的输送杆的结构示意图,其中输送杆包括两个第二连接件;
图5为本发明实施例一的输送装置与自扩张编织支架相连接的示意图;
图6a为本发明实施例一的第一连接件形成空隙的原理图;
图6b为本发明实施例一的第二连接件的最大直径大于第一连接件上空隙的示意图;
图7为本发明实施例二的自扩张编织支架的近端之卡扣件的放大示意图;
图8为本发明实施例二的输送杆的结构示意图,其中输送杆包括一个第二连接件;
图9为本发明实施例二的第一连接件和第二连接件卡合连接的原理图;
图10为本发明实施例二的输送装置与自扩张编织支架相连接的示意图,其中自扩张编织支架的近端仍未脱离输送鞘管;
图11为本发明实施例三的自扩张编织支架的近端之卡扣件的放大示意图;
图12本发明实施例三的输送装置与自扩张编织支架相连接的示意图,其中自扩张编织支架的近端仍未脱离输送鞘管;
图13为图12所示的自扩张编织支架与输送杆卡合连接的放大示意图;
图14为本发明实施例四的输送装置与自扩张编织支架相连接的示意图,其中自扩张编织支架的近端未脱离解脱束缚管。
图中:
1-支架,11-近端,12-远端;13-卡扣件;14、15-第一连接组;2-第一连接件;3-第二连接件;4-输送杆;5-输送鞘管;6-解脱束缚管;
G-表面凹槽;S1、S2、S-编织丝;Q-焊接点。
附图中用相同的附图标记表示相同或相似的部件。
具体实施方式
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书和所附权利要求中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的, 除非内容另外明确指出外。术语“多个”通常是以包括两个或两个以上的含义而进行使用的,除非内容另外明确指出外。术语“若干”以包括一个或多个的含义而进行使用的,除非内容另外明确指出外。
此外,在以下说明中,为了便于描述,使用了“远端”和“近端”;“近端”是接近医疗器械操作者的一端;“远端”是远离医疗器械操作者的一端。另外,在下文的描述中,给出了大量具体的细节以便提供对本发明更为彻底的理解。然而,对于本领域技术人员而言显而易见的是,本发明可以无需一个或多个这些细节而得以实施。在其他的例子中,为了避免与本发明发生混淆,对于本领域公知的一些技术特征未进行描述。
本发明的核心思想在于提供一种医疗设备,包括血管植入物和输送装置;所述血管植入物通过输送装置递送至目标位置,且所述输送装置包括输送杆和腔室。
本发明的血管植入物具有近端,且所述近端包括第一连接部。本发明的输送装置中,所述输送杆包括第二连接部。所述第一连接部用于与所述第二连接部可分离地卡合连接,从而使所述血管植入物与所述输送杆在轴向上保持相对静止。
其中,所述第一连接部和所述输送杆用于容纳于所述腔室中。当所述第一连接部和所述输送杆容纳于所述腔室时,所述第一连接部受到所述腔室的约束力而与所述第二连接部保持卡合的状态,从而实现所述血管植入物与所述输送杆间的轴向锁定。反之,当所述第一连接部脱离所述腔室时,所述第一连接部即被解除所述腔室的约束而与所述第二连接部处于可分离的状态,最终实现所述血管植入物与所述输送杆间的轴向解锁。这样一来,血管植入物和输送杆实现了可分离的机械连接,从而在输送过程中,可以避免血管植入物发生脱载的问题,使得血管植入物能够被稳定地输送,以此降低手术操作难度,提高手术操作安全性和治疗效果。
进一步的,所述输送装置还包括约束件,且所述约束件包括所述腔室,所述约束件用于设置于所述输送杆的外部。在一实施例中,所述输送装置还包括用于装载血管植入物的输送鞘管,所述输送杆可活动地插入所述输送鞘 管,且所述输送鞘管构成所述约束件。在一实施例中,所述约束件为一解脱束缚管,其可活动地插入所述输送鞘管并套在所述输送杆的外部以包裹第一连接部和输送杆。其中,所述第一连接部可包括一个或两个以上的第一连接件,且一个或两个以上的第一连接件用于与所述第二连接部可分离地卡合连接。而所述第二连接部可包括一个或两个以上的第二连接件,且一个或两个以上的第二连接件用于与所述第一连接部可分离地卡合连接。
在本发明中,形成卡合连接的方式主要有:
(1)将至少一个所述第一连接件卡合在至少两个所述第二连接件之间;
(2)将至少一个所述第二连接件卡合在至少两个所述第一连接件之间;
(3)将至少一个所述第一连接件卡合在至少一个所述第二连接件中。
实际操作中,上述形成卡合连接的方式可组合使用,也可单独使用,而且不限于仅实现一对卡合连接,也可设置两个以上的卡合连接来形成更可靠的连接。
本发明中,所述血管植入物主要为用于治疗血管动脉瘤的植入物,例如是支架、弹簧圈或动脉瘤封堵装置等,也可用于血管扩张、血管栓塞捕获或其他管腔病变的治疗。以约束件为输送鞘管为例,本发明的血管植入物的输送过程具体包括以下几个步骤:
首先是血管植入物的装载:先将血管植入物套设在输送杆的外部,然后将血管植入物和输送杆一起装入输送鞘管,此时,在输送鞘管的径向约束下,所述第一连接部和第二连接部保持在卡合状态,实现了血管植入物和输送杆间的轴向锁定;
而后是血管植入物的输送:利用输送杆推动血管植入物,使血管植入物整个(包括近端)脱离输送鞘管,由于来自输送鞘管的径向约束被解除,而使得血管植入物发生扩张(或称膨胀),使得第一连接部与第二连接部相分离而解除卡合,从而实现了血管植入物在体内的释放。
其中,血管植入物脱离输送鞘管后的扩张方式可以是自扩张,也可以是被动扩张。所述“自扩张”是指血管植入物具有自膨胀特性,在解除外力约束后自身可发生膨胀或展开;所述“被动扩张”是指借助于外部机构,如扩 张球囊使血管植入物在解除外力约束后膨胀或展开。
在一替代性实施例中,所述约束件为解脱束缚管,可活动地插入在输送鞘管内并套在输送杆的外部,实际操作时,利用解脱束缚管还可实现血管植入物的全释放和全回收。对于该操作过程将在以下描述中详细说明。这样做方便在植入释放后观察植入物的位置和状态,并根据需要重新调整植入位置,从而提高血管植入物在体内释放的准确性,改善治疗效果。
以下结合附图和若干实施例对本发明提出的血管植入物及输送装置作进一步的说明。并且下文中,假定血管植入物为支架,但本领域技术人员应当能够修改以下描述,将其应用于不是支架的情况。
如图1所示,血管植入物可为支架1,支架1可以是切割支架及编织支架中的一种或多种的组合,且支架1可以为自扩张支架,也可以是被动扩张支架。切割支架可以由形状记忆材料或弹性材料制成,包括却不限于镍钛合金。编织支架可以由金属或高分子材料制成的编织丝编织而成,包括但不限于镍钛合金、不锈钢或高分子聚合物。
以下描述中,主要以自扩张编织支架为例进行描述,但本领域技术人员也应当能够修改以下描述,将其应用于不是自扩张编制支架的情况。
继续参阅图1,支架1具有相对的近端11和远端12。支架1的近端11可以是单股或两股及以上的编织丝束缚在一起形成,也可以是单根丝回编而成,本发明对此具体不作限制。其中编织丝的束缚方式可采用但不限于拧结、胶结、焊接等方式。在一非限制性的实施例中,如图2a所示,位于近端11的相邻两根编织丝S1及S2可并丝焊接在一起,并可在多个部位形成焊接点Q。
参阅图2b,并结合图2a所示,单根编织丝S1或S2和/或两根编织丝S1及S2可进一步缠绕形成一个螺旋管状的卡扣件13。但是,也可在支架1的近端11额外利用外部丝缠绕形成螺旋管状的卡扣件13。或者,还可以直接在近端11套设管状的卡扣件13来包覆束缚在一起的编织丝。本发明对卡扣件13在支架1的近端的设置方式不作特别的限制。
本实施例中,卡扣件13可以为中空管状结构,包括但不限于螺旋形式。 卡扣件13也可以是实心构件,例如在并丝焊接在一起的两根编织丝的近端直接连接一个实心柱体来形成卡扣件13。所以,本发明对卡扣件13的结构不作特别的限制,只要便于实现编织丝与卡扣件连接即可。本实施例中,卡扣件13优选为管状并包裹编织丝,另外管状更优选为螺旋式,以提供弹性。当卡扣件13为螺旋管状时,可在支架1的轴向上被压缩形变而方便卡接,从而降低卡接的难度,使操作更为方便。卡扣件13可由高分子材料或金属材料制成,包括但不限于不锈钢、镍钛合金等,较佳的,卡扣件13由不透射线的金属显影材料制成,以便在植入过程中观察支架1的近端11的具体位置。
本发明实施例中,支架1的近端11包括第一连接部,且所述第一连接部包括至少一个第一连接件2(参阅图6a),第一连接件2被配置为,在受到腔室的约束力时与输送杆实现卡合,并在解除所述腔室的约束力时与输送杆处于可分离的状态。优选的,第一连接件2包括两个以上卡扣件13,两个以上卡扣件13围绕支架1的轴线对称布置(即沿支架1的周向对称设置,或称中心对称设置)。从而两个以上卡扣件13之间(如图6a中d1标示位置)会形成空隙,空隙的尺寸可在较大尺寸和较小尺寸之间转换,主要与支架的压缩和扩张有关。以输送鞘管构成约束件为例,支架1装载进入输送鞘管之前,由于在径向上还并未受到腔室的约束力,支架1没有被压缩而使空隙的尺寸较大,使得输送杆的第二连接件3能够通过该空隙,从而方便将支架1装载在输送杆上。当支架1与输送杆保持配合状态(卡合)装载进入输送鞘管之后,由于支架1受到腔室的约束力被压缩而使空隙的尺寸减小,使得输送杆的第二连接件3无法在轴向上通过此时的空隙,因此,此时的空隙的最大尺寸(例如直径)小于第二连接件3的尺寸(例如直径),从而可确保支架近端的第一连接件2和输送杆远端的第二连接件3保持在卡合状态而不会分离,由此实现输送杆和支架1间的轴向锁紧,进而能够通过输送杆实现支架1在输送鞘管中的输送。当腔室的约束力解除时,支架1释放而膨胀,第一连接件2即可与第二连接件3分离,实现输送杆和支架1间的轴向解锁。
进一步的,参阅图3a至图3d,并结合图4,输送装置包括输送杆4,输送杆4包括第二连接部,且所述第二连接部包括至少一个第二连接件3。本实 施例中,输送杆4还包括杆件本体,在所述杆件本体上形成有至少一个第二连接件3。在一些实施例中,在所述杆件本体上形成有至少一个凸部,且所述凸部构成第二连接件3,使得至少一个第一连接件2能够卡合在至少两个凸部之间,或者至少两个第二连接件3能够卡合在至少一个凸部的相对两侧。在一些实施例中,在所述杆件本体上形成有至少一个凹部,且所述凹部构成第二连接件3,使得至少一个第一连接件2能够卡合在至少一个凹部中。
以下描述中,假定第二连接件3为凸部,来进一步说明容易实现第一连接部和第二连接部之间的卡合连接,但本领域技术人员应该能够修改以下描述将其应用于不是凸部的情况。
结合图2b,实际应用时,当支架1受到输送鞘管的径向约束时,各个卡扣件13搭接于第二连接件3上而形成卡合连接且被输送鞘管束缚而无法解脱,这种卡合式的物理连接能够提供更为稳定的输送。而且当卡扣件13从输送鞘管推出后,来自输送鞘管的束缚解除,使卡扣件13从第二连接件3上解脱,这样的解脱方式也十分方便、快捷,而且结构也简单,可实现支架1的快速释放。
与现有技术相比,支架1通过与输送杆之间的机械连接实现在输送鞘管中的输送,这样做使得支架1在输送过程中不容易脱落,从而提高了支架输送的稳定性。而且卡扣连接的结构简单,锁定和解锁也较为方便。
继续参阅图3a至图3c,在一些实施例中,第二连接件3具有轴向贯通的表面凹槽,但表面凹槽可以由如图3b或图3c所示的缺口构成,也可以由图3a所示的相邻凸起限定而成。如图3d所示,在另一些实施例中,第二连接件3也可以是表面光滑的柱体,但柱体的横截面的形状不作限定,可以是圆形、方形、长方形或异形。第二连接件3可以是实心构件,也可以是管状构件,而管状构件也可以是螺旋式。第二连接件3可由高分子材料或金属材料制成,包括但不限于不锈钢、镍钛合金等,较佳的,第二连接件3由不透射线的金属显影材料制成,以便在植入过程中观察其位置及其与输送鞘管的轴向相对位置以判断支架1的释放状态。
进一步的,所述表面凹槽为两个以上且围绕第二连接件3的轴线设置(即 沿第二连接件3的周向间隔布置,更优选沿第二连接件3的周向对称设置)。进而通过第二连接件3上的表面凹槽,可在卡合时,将支架1的近端11的一部分编织丝容纳于表面凹槽中,一方面可减小支架1压缩后的直径,从而减小输送鞘管的直径,另一方面也可进一步约束支架1和输送杆,从而进一步提高支架输送的稳定性。
进一步的,所述支架1的近端11包括若干网格,其中在至少部分网格的末端上设置卡扣件13,即,不必在支架近端的所有网格设置卡扣件13,而一个第一连接件2包括在不同网格上的两个以上卡扣件13,且每个第一连接件2中的卡扣件13在同一圆周上对称布置。
以下对第一连接件2和第二连接件3形成卡扣连接的方式作进一步的说明,但以下描述不作为对本发明的限定,任何在以下内容基础上所作的变换均在本发明的保护范围之内。
实施例一
如图4所示,本实施例中,输送杆4包括第二连接部,所述第二连接部包括至少两个第二连接件3,至少两个第二连接件3在杆件本体的轴向上间隔地设置。假定第二连接件3为两个,两个第二连接件3的轴向距离被配置为允许卡合至少一个第一连接件2。由于第一连接件2可以为具有弹性的构件,因此可被压缩在两个第二连接件3之间,故而两个第二连接件3间的轴向距离可以小于或等于第一连接件2的轴向长度(即压缩之前的长度)。但是第一连接件2还可以为不具有弹性的刚性构件,即不可变形,此时,两个第二连接件3间的轴向距离可以大于或等于第一连接件2的轴向长度,且为了避免在轴向上产生较大的位移,两个第二连接件3与第一连接件2间的间隙不应过大。然而第二连接件3也可以是具有弹性的构件,方便通过变形来卡合一个第一连接件2,因此,两个第二连接件3间的轴向距离也可以小于或等于第一连接件2的轴向长度。
如图5所示,并结合图2b所示,第一连接件2包括四个在同一圆周上间隔设置的卡扣件13,每个卡扣件13设置于支架1之近端11的编织丝上,且 这些卡扣件13的结构可以相同或不相同,还可以是两端对齐或不对齐均可。输送装置还包括输送鞘管5。实际操作时,如图5所示,在输送鞘管5内,整个支架1被压缩而使近端11的四个卡扣件13也被压缩而卡合在两个第二连接件3之间,即其中一个第二连接件3卡合于第一连接件2的近端,另一个第二连接件3卡合于第一连接件2的远端,因此,从相反的两个方向上阻止支架1的移动。
此外,第二连接件3的外表面上形成有所述表面凹槽,使得支架1的近端11的编织丝连接成整体后嵌入位于远端的第二连接件3的表面凹槽中。因此,两个第二连接件3的结构可以不相同或相同,其中较佳地位于远端的一个第二连接件3上设置有表面凹槽,另一个可不设置表面凹槽。
如图6a和图6b所示,当支架1压缩在输送鞘管5内(即支架1在完全压缩状态下),四个卡扣件13之间形成空隙(即图中d1标识);当所述空隙为规则图形,例如圆形时,第二连接件3的直径d2(例如最大尺寸)需要大于空隙的直径d1;而当所述空隙为不规则图形时,第二连接件3的直径d2需要大于空隙的最大尺寸;这样做能够保证第二连接件3在推送时不会从空隙中滑脱。
继续参阅图6a和图6b所示,支架1在完全压缩状态下,所述表面凹槽的径向距离L1可以等于或大于空隙的径向距离(d1/2),表面凹槽的径向距离L1也可以小于空隙的径向距离(d1/2),即对表面凹槽的深度没有特别的限定。但是为了避免卡扣件13进入表面凹槽而发生滑脱,所述表面凹槽的尺寸较佳地被配置为禁止卡扣件13通过,优选将表面凹槽沿第二连接件3周向的最大尺寸设计为小于卡扣件13沿支架1周向的最小尺寸。
因此,实际操作时,如图5所示,在回撤输送杆4时(即使得输送杆4向近端方向移动),位于远端的一个第二连接件3限制第一连接件2,使第一连接件2与输送杆4之间不会产生相对移动;反之,向前推送输送杆4时(即使得输送杆4向远端方向移动),位于近端的一个第二连接件3限制第一连接件2,使第一连接件2与输送杆4之间也不会产生相对移动。
实施例二
如图7和图8所示,本实施例中,输送杆4的第二连接部包括至少一个第二连接件3,同时所述支架1之近端11的第一连接部包括至少两个第一连接件2,至少两个第一连接件2在支架1的近端沿轴向间隔排列。以下假定第一连接件2为两个。两个第一连接件2间的轴向距离被配置为允许卡合至少一个第二连接件3。这里,两个第一连接件2间的轴向距离可以大于第二连接件3的轴向长度,也可以小于或等于第二连接件3的轴向长度,例如第一连接件2为弹性件,可被拉伸或压缩。
如图9所示,实际操作时,在输送鞘管5内,一个第二连接件3卡合在两个第一连接件2之间,且位于两个第一连接件2之间的编织丝S插入第二连接件3上的表面凹槽G中。进而输送过程中,若向前(即向远端)推送支架1,则第二连接件3将阻挡位于近端的一个第一连接件2,保证支架1与输送杆4之间不会产生相对移动;反之,若回撤支架1,则第二连接件3阻挡位于远端的一个第一连接件2。这样做,支架1在输送和回收时均不会与输送杆4之间产生相对移动,使支架1能够被稳定地输送。
进一步的,如图10所示,若要释放支架1,只要向前推送支架1,直至支架1的近端11全部推出输送鞘管5,即可使第一连接件2沿径向向外弹出而解除卡合,使支架1释放,因此,解脱也方便。
实施例三
本实施例中,支架近端的第一连接部包括两个以上第一连接组,两个以上所述第一连接组沿支架1的轴向间隔设置,且每个第一连接组包括两个以上第一连接件2,每个所述第一连接组中的两个以上第一连接件2沿支架1的轴向间隔设置,且同一个第一连接组中的卡扣件13在支架1的轴向上对齐布置。轴向上对齐是指,在垂直于支架轴线的同一个投影平面上,同一个第一连接组中的卡扣件13的轴向投影是重合的。
进一步,发明人发现,当第一连接件2的径向尺寸较大,或卡扣件13数量较多时,支架1及其输送装置的压缩尺寸过大。为了解决此问题,将不同 第一连接组中的卡扣件13在支架1的轴向上错开布置,从而使不同第一连接组中的卡扣件13可压缩在不同的圆周上,从而减小压缩尺寸,进而减小输送鞘管5的尺寸,便于支架1在更小的输送鞘管内输送。
如图11所示,本实施例中,所述第一连接组的数量为两个,分别为第一连接组14及15,且为了更清楚,图中以虚线限定了该两个第一连接组14及15。第一连接组14及15沿支架1的轴向间隔设置,且第一连接组14及15中的卡扣件13在轴向上错开布置。此处,轴向上错开是指,在垂直于支架轴线的同一个投影平面上,第一连接组14及15中的卡扣件13的轴向投影是不重合的。
更具体的,第一连接组14包括由远及近依次布置的两个第一连接件2,该两个第一连接件2沿支架1的轴向间隔设置,且该两个第一连接件2的卡扣件13在轴向上对齐布置。同样的,第一连接组15包括由远及近依次布置的两个第一连接件2,该两个第一连接件2亦沿支架1的轴向间隔设置,且该两个第一连接件2的卡扣件13在轴向上对齐布置。
以每个第一连接件2包括两个卡扣件13作为示意,如图11所示,由远及近,在支架1的近端11依次设置第一个、第二个、第三个和第四个第一连接件2,最远端的第一个第一连接件2中的两个卡扣件13与相邻的第二个第一连接件2中的两个卡扣件13在轴向上对齐布置,而第三个第一连接件2和最近端的第四个第一连接件2亦是如前两个第一连接件2那样设置,但是后两个第一连接件2的卡扣件13与前两个第一连接件2的卡扣件13在轴向上错开。这样设置,使得卡扣件13的轴向位置在周向上有所不同(即轴向上错开布置),从而使支架1压缩在输送鞘管5内的尺寸会更小,使得支架1可以在更小尺寸的输送鞘管内输送。
本实施例中,如图4所示,输送杆4包括两个第二连接件3,分别与两个第一连接组14及15卡合连接。如图12和图13所示,位于近端的两个第一连接件2之间设置一个第二连接件3,位于远端的两个第一连接件2之间设置另一个第二连接件3,由此限制了支架1和输送杆4之间的相对位置,从而在减小尺寸的同时也实现了稳定且可靠的连接。
实施例四
本实施例的支架和输送装置的结构与上述实施例基本相同,以下仅针对不同点进行描述。
本实施例中,如图14所示,所述输送装置还包括解脱束缚管6,用于可活动地设置在输送鞘管5的内部并套在输送杆4的外部,以实现支架1的全释放与全回收。这里,所述解脱束缚管6即构成所述约束件。
具体的,将整个支架1推出输送鞘管5后,使支架1全释放于目标位置,此时支架的近端11与输送杆4仍未分离,如果尚未达到理想的解脱状态(例如支架未完全释放或解脱),仍可通过回撤输送杆4而实现支架1全部或部分回收至输送鞘管5中。当满足解脱条件(例如释放位置确认正确无误)时,解脱束缚管6与输送杆4相对移动,例如由术者操作输送杆4向前(向远端)移动,而保持解脱束缚管6不动,或者解脱束缚管6后撤但输送杆4不动,使得解脱束缚管6对支架1的近端11所施加的束缚解除,使支架1与输送杆4实现分离,进而实现解脱。与现有技术相比,本发明可在支架1(除近端11外)全释放后又能够全回收,直至达到理想的释放位置和释放状态后,再将支架1的近端11与输送杆4解脱,这样设置可提高支架1在体内释放的准确性,从而改善治疗效果。
更具体地,解脱束缚管6包裹第二连接件3及第一连接件2,使第二连接件3和第一连接件2保持卡合的状态,当输送杆4与解脱束缚管6之间未存在相对位移时,支架1和输送杆4之间卡合连接。当解脱束缚管6相对输送杆4向近端移动时,支架1的近端11与第二连接件3径向失去束缚,而支架1本身有自膨胀的特性,因此支架1的近端11从第二连接件3中沿径向方向弹开,支架1的近端11与输送杆4分离,从而解脱。
本实施例中,解脱束缚管6的远端延伸至支架1的近端11即可,只要能够约束第一连接件2,而解脱束缚管6的近端延伸出输送鞘管5的近端而便于术者操作。此外,对解脱束缚管6的材料不作限定,可以是高分子材料或金属材料。
此外,需要说明的是,当一个第二连接件3卡合于两个第一连接件2之间时,两个第一连接件2在轴向间隔设置的同时,其卡扣件13既可在轴向上对齐布置,也可在轴向上错开布置,如果轴向上错开布置,有利于减小压缩尺寸。
上述实施例对如何连接支架和输送杆进行了详细说明,当然,本发明包括但不局限于上述实施中所列举的连接方式,任何在上述实施例提供的连接方式基础上进行变换的内容,均属于本发明所保护的范围。本领域技术人员可以根据上述实施例的内容举一反三。
上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。

Claims (21)

  1. 一种血管植入物,通过输送装置递送至目标位置,所述输送装置包括输送杆和腔室,其特征在于,所述血管植入物具有近端,所述近端包括第一连接部,所述第一连接部用于与所述输送杆可分离地卡合连接,且所述第一连接部和所述输送杆能够容纳于所述腔室或者脱离所述腔室;
    当所述第一连接部和所述输送杆容纳于所述腔室时,所述第一连接部受到所述腔室的约束力而与所述输送杆保持卡合的状态,以实现所述血管植入物与所述输送杆间的轴向锁定;
    当所述第一连接部脱离所述腔室时,所述第一连接部被解除所述腔室的约束力而与所述输送杆处于可分离的状态,以实现所述血管植入物与所述输送杆间的轴向解锁。
  2. 根据权利要求1所述的血管植入物,其特征在于,所述第一连接部包括至少一个第一连接件;所述第一连接件被配置为,在受到所述腔室的约束力时与所述输送杆保持卡合的状态,并在解除所述腔室的约束力时与所述输送杆处于可分离的状态;其中:所述第一连接件具有空隙;
    当所述第一连接部和所述输送杆容纳于所述腔室时,所述空隙被配置为禁止所述输送杆通过,以使所述第一连接件和所述输送杆保持卡合的状态;
    当所述第一连接部脱离所述腔室时,所述空隙被配置为允许所述输送杆通过,以使所述第一连接件和所述输送杆处于可分离的状态。
  3. 根据权利要求2所述的血管植入物,其特征在于,所述第一连接件包括两个以上的卡扣件,两个以上所述卡扣件沿所述血管植入物的周向间隔设置,且两个以上所述卡扣件之间形成所述空隙。
  4. 根据权利要求3所述的血管植入物,其特征在于,所述卡扣件被配置为在所述血管植入物的轴向上能够变形,以使所述第一连接件在所述血管植入物的轴向上能够变形。
  5. 根据权利要求3所述的血管植入物,其特征在于,所述两个以上的卡扣件中的至少一个由金属显影材料制成。
  6. 根据权利要求3-5中任一项所述的血管植入物,其特征在于,所述第一连接部包括两个以上所述第一连接件,两个以上所述第一连接件沿所述血管植入物的轴向间隔设置。
  7. 根据权利要求6所述的血管植入物,其特征在于,两个以上所述第一连接件中的所述卡扣件在所述血管植入物的轴向上对齐布置。
  8. 根据权利要求3-5中任一项所述的血管植入物,其特征在于,所述第一连接部包括两个以上第一连接组,两个以上所述第一连接组沿所述血管植入物的轴向间隔设置;
    每个所述第一连接组包括两个以上所述第一连接件,每个所述第一连接组中的所述第一连接件沿所述血管植入物的轴向间隔设置;
    其中:同一第一连接组中的所述卡扣件在所述血管植入物的轴向上对齐布置,且不同第一连接组中的所述卡扣件在所述血管植入物的轴向上错开布置。
  9. 根据权利要求1所述的血管植入物,其特征在于,所述血管植入物为自扩张植入物。
  10. 根据权利要求1所述的血管植入物,其特征在于,所述血管植入物为支架、弹簧圈或动脉瘤封堵装置。
  11. 一种输送装置,用于将血管植入物递送至目标位置,其特征在于,包括:
    输送杆,所述输送杆包括第二连接部,所述第二连接部用于与所述血管植入物的近端可分离地卡合连接;以及
    腔室,用于容纳所述输送杆和所述血管植入物的近端;
    当所述血管植入物的近端和所述输送杆容纳于所述腔室时,所述血管植入物的近端受到所述腔室的约束力而与所述第二连接部保持卡合的状态,以实现所述血管植入物与所述输送杆间的轴向锁定;
    当所述血管植入物的近端脱离所述腔室时,所述血管植入物的近端被解除所述腔室的约束力而与所述第二连接部处于可分离的状态,以实现所述血管植入物与所述输送杆间的轴向解锁。
  12. 根据权利要求11所述的输送装置,其特征在于,所述第二连接部包括至少一个第二连接件,用于与所述血管植入物的近端可分离地卡合连接;
    所述输送杆还包括杆件本体,所述杆件本体上形成有至少一个凸部,且所述凸部为所述第二连接件,以使所述血管植入物的近端卡合在至少一个所述凸部的两侧或卡合在至少两个所述凸部之间。
  13. 根据权利要求11所述的输送装置,其特征在于,所述第二连接部包括至少一个第二连接件,用于与所述血管植入物的近端可分离地卡合连接;
    所述输送杆还包括杆件本体,所述杆件本体上形成有至少一个凹部,且所述凹部为所述第二连接件,以使所述血管植入物的近端卡合在所述凹部中。
  14. 根据权利要求12所述的输送装置,其特征在于,所述第二连接件具有轴向贯通的表面凹槽,用于容纳部分所述血管植入物。
  15. 根据权利要求14所述的输送装置,其特征在于,所述表面凹槽为两个以上且沿所述第二连接件的周向布置。
  16. 根据权利要求14所述的输送装置,其特征在于,所述血管植入物的近端包括至少一个第一连接件,所述第一连接件用于与所述第二连接件可分离地卡合连接,且所述第一连接件包括两个以上的卡扣件,两个以上所述卡扣件沿所述血管植入物的周向间隔设置,且两个以上所述卡扣件之间形成空隙;
    当所述血管植入物的近端和所述输送杆卡合并容纳于所述腔室时,所述表面凹槽被配置为禁止所述卡扣件通过。
  17. 根据权利要求11所述的输送装置,其特征在于,所述第二连接部由金属显影材料制成。
  18. 根据权利要求11-17中任一项所述的输送装置,其特征在于,所述输送装置还包括约束件,所述约束件包括所述腔室并设置于所述输送杆的外部。
  19. 根据权利要求18所述的输送装置,其特征在于,所述输送装置还包括用于装载所述血管植入物的输送鞘管,所述输送杆用于可活动地插入所述输送鞘管,且所述输送鞘管构成所述约束件。
  20. 根据权利要求18所述的输送装置,其特征在于,所述输送装置还包 括用于装载所述血管植入物的输送鞘管,所述输送杆用于可活动地插入所述输送鞘管;所述约束件用于可活动地插入所述输送鞘管,以包裹所述血管植入物的近端和所述输送杆。
  21. 一种医疗设备,其特征在于,包括:
    如权利要求1-10中任一项所述的血管植入物;以及
    如权利要求11-20中任一项所述的输送装置;
    其中,所述血管植入物的第一连接部用于与所述输送杆的第二连接部可分离地卡合连接。
PCT/CN2020/098312 2019-06-28 2020-06-26 血管植入物、输送装置及医疗设备 WO2020259640A1 (zh)

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