WO2015090188A1 - 一种支架输送系统及其后释放组件 - Google Patents

一种支架输送系统及其后释放组件 Download PDF

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Publication number
WO2015090188A1
WO2015090188A1 PCT/CN2014/093973 CN2014093973W WO2015090188A1 WO 2015090188 A1 WO2015090188 A1 WO 2015090188A1 CN 2014093973 W CN2014093973 W CN 2014093973W WO 2015090188 A1 WO2015090188 A1 WO 2015090188A1
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WO
WIPO (PCT)
Prior art keywords
release assembly
delivery system
stent
jaw
rear end
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
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PCT/CN2014/093973
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English (en)
French (fr)
Inventor
李中华
朱清
朱永锋
罗七一
黄定国
姬庆茹
李彪
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MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd
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MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd
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Application filed by MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd filed Critical MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd
Priority to EP14872805.8A priority Critical patent/EP3085340B1/en
Priority to BR112016013956-9A priority patent/BR112016013956B1/pt
Priority to PL14872805T priority patent/PL3085340T3/pl
Priority to ES14872805T priority patent/ES2873477T3/es
Publication of WO2015090188A1 publication Critical patent/WO2015090188A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the invention relates to the field of medical instruments, in particular to an aortic stent delivery system for interventional treatment of aortic aneurysms, including aortic dissection.
  • the invention also relates to a rear release assembly of a delivery system.
  • Aortic diseases such as aortic aneurysm and aortic dissection are among the most deadly and most difficult vascular surgical diseases.
  • the traditional treatment method is open surgery, which performs artificial blood vessel replacement.
  • open surgery has a large trauma and a high mortality rate.
  • the delivery of the stent graft for the delivery system for the treatment of aortic aneurysm minimally invasive intervention is relatively simple, that is, the outer tube is withdrawn, and then the stent bounces off due to its own elasticity.
  • This release method is not accurate enough in the release control of the stent graft because the stent graft is directly bounced after the outer tube is withdrawn, and if the stent graft is not properly released, it can only be removed by open surgery.
  • the stent graft has large surgical trauma and high mortality.
  • the Chinese utility model patent CN202699194U discloses a branch abdominal aortic stent graft and a delivery system thereof.
  • the branched abdominal aortic stent graft comprises a mesh tubular stent made of a memory alloy and a coating coated on the tubular tubular stent, and at least two sleeves are arranged on the step of the front portion in the tubular tubular stent.
  • the branching, delivery system then includes a release assembly that extends into the tubular stent.
  • the release assembly includes a lead wire and a bending sleeve, the front end of the bending sleeve extends into the mesh tubular bracket, and is bent to one side into a sleeve branch corresponding thereto, and one of the lead wires The end is placed at the end of the bent sleeve and the other end is inserted into the bent sleeve and connected to its corresponding sleeve branch.
  • This delivery system is still not accurate enough in the release control of the stent graft. If the release position of the stent graft is incorrect, the stent graft can only be removed by open surgery.
  • the present invention provides a delivery system to overcome the above problems.
  • the proximal end of the stent can be released later, that is, after the outer sheath is withdrawn, the stent is in a semi-release state, and the proximal end is still restrained, so that the position of the stent can be finely adjusted to accurately position the stent.
  • the present invention provides a rear release assembly for a delivery system.
  • the rear release assembly is located at a proximal end of the delivery system, the rear release assembly including a front end fastener, a rear end jaw, and a control guidewire from the proximal end to the distal end, the proximal end of the rear end jaw Separably coupled to the front end fastener, the distal end of the rear end jaw is coupled to the control guidewire.
  • the semi-release of the stent can be achieved, that is, when the stent body is deployed, the proximal end of the stent is still bound, so that the position of the stent can be precisely adjusted, and the proximal end of the stent is released after the final position is determined, so that the stent is completely completed.
  • the rear end jaws can be a single component or a combination of several components.
  • the material of the rear jaws may be a polymer or a metal.
  • the rear release assembly further includes a guide member through which the rear end claw passes, guided and held by the guide member.
  • the material of the guiding member may be a polymer material or a metal.
  • the rear release assembly further includes a claw guide wire connector, the distal end of the rear end jaw being coupled to the control guide wire via the jaw guide wire connector, the claw A proximal end of the guidewire connector is fixedly coupled to the rear end jaw or the rearward jaw is integrally formed with the jaw guidewire connector, a distal end of the jaw guidewire connector and the control
  • the guide wires are fixedly connected or movably connected.
  • the material of the claw wire connecting member may also be a polymer material or a metal. High Molecular materials include, but are not limited to, Pebax, Nylon, PC, PE, PP, ABS.
  • the rear end jaw comprises a plurality of poles distributed in the circumferential direction.
  • the rear end jaw further comprises a member defining an inner tube bore, the inner tube aperture allowing an inner tube of the delivery system to pass through, and the component defining the inner tube aperture is The plurality of poles are connected or integrated.
  • the front end fixing member is provided with a plurality of blind holes corresponding to the plurality of wave rods in a circumferential direction, and the plurality of wave rods are respectively inserted into the plurality of blind holes.
  • the guide member is provided with a plurality of perforations corresponding to the plurality of corrugated rods in a circumferential direction, and the plurality of corrugated rods respectively pass through the plurality of perforations.
  • the guide member can guide and maintain the direction of each of the wave rods of the rear end jaws, avoiding crossing or bending, and facilitating the alignment of the plurality of wave rods of the rear end jaws and the blindness of the front end fixing members. In the hole.
  • the present invention provides a delivery system for a stent, the delivery system comprising an outer sheath tube, an inner tube and a stent.
  • the delivery system further includes a posterior release assembly for controlling proximal release of the stent, the posterior release assembly extending longitudinally within the outer sheath tube and being passed through the inner tube, and the proximal end of the stent A perforation is provided through which the rear end jaw passes to bind the proximal end of the stent.
  • the posterior release assembly is used in conjunction with a proximally-spaced stent that binds the proximal end of the stent such that after the outer sheath is retracted, the stent body is deployed and the proximal end of the stent is restrained Can not be bounced, at this time the bracket can be slightly fine-tuned to achieve accurate positioning of the bracket, after confirming the precise position of the bracket, the proximal end of the bracket can be released by controlling the rear release assembly, so that the bracket is fully deployed.
  • the delivery system further includes a tapered head at a proximal end of the delivery system that is coupled to the proximal end of the front end fastener.
  • the delivery system and the rear release assembly according to the present invention impart a function of releasing the proximal end of the stent to make the release of the stent more precise.
  • FIG. 1 is a schematic perspective view of a rear release assembly in accordance with an embodiment of the present invention.
  • FIG. 2 is a schematic perspective view of a front end fastener of a rear release assembly in accordance with an embodiment of the present invention.
  • FIG 3 is a schematic perspective view of a guide of a rear release assembly in accordance with an embodiment of the present invention.
  • FIG. 4 is a schematic perspective view of a rear end jaw of a rear release assembly in accordance with an embodiment of the present invention.
  • Figure 5 is a schematic perspective view of a rear end jaw of a rear release assembly in accordance with another embodiment of the present invention.
  • Figure 6 is a schematic perspective view of a rear end jaw of a rear release assembly in accordance with yet another embodiment of the present invention.
  • Figure 7 is a schematic illustration of the proximal end of a stent in accordance with the present invention.
  • FIGS. 8-10 are schematic views of a process of a delivery system releasing a stent in accordance with an embodiment of the present invention.
  • distal and “near end” and “longitudinal” are used, and “distal” and “near end” refer to one side of the operating end of the conveying system and the side far from the operating end, respectively.
  • distal and “near end” refer to one side of the operating end of the conveying system and the side far from the operating end, respectively.
  • longitudinal refers to the direction of extension of the delivery system.
  • FIG. 1 shows a rear release assembly in accordance with an embodiment of the present invention.
  • the rear release assembly is composed of a front end fixing member 1, a guiding member 2, a rear end claw 3, a claw wire connecting member 4, and a control guide wire 5 in order from a proximal end P to a distal end D.
  • Figure 1 also shows the inner tube 6 of the delivery system that passes through the various components of the rear release assembly.
  • Figure 2 shows the front end fastener 1.
  • the front end fixing member 1 has an inner tube hole 1a.
  • the number of the blind holes corresponds to the number of the rods 3a of the rear end claws 3, so that the rod 3a of the rear end claws 3 Insert the corresponding blind hole 1b.
  • the processing technology of the front end fixing member 1 may be injection molding or machining.
  • Figure 3 shows the guide 2.
  • the guide member 2 has an inner tube hole 2a for the inner tube 6 to pass through, and a plurality of guide holes 2b distributed in the circumferential direction.
  • the number of the guide holes is the same as the number of the wave rods 3a of the rear end claws 3, so that the wave rods 3a of the rear end claws 3 pass through to guide and hold the direction of each of the wave rods 3a of the rear end claws 3, avoiding It is crossed or curved, and it is convenient to align and introduce the wave rod 3a of the rear end claw 3 into the blind hole 1b of the front end fixing member 1.
  • the processing process of the guide member 2 may be injection molding or machining.
  • the material of the guiding member may be a polymer material or a metal, and the polymer materials used include, but are not limited to, Pebax, Nylon, PC, PE, PP, ABS.
  • Figure 4-6 shows the rear jaw 3 .
  • the rear end claw 3 includes a plurality of wave rods 3a distributed in the circumferential direction, which are fixedly coupled to the member 3b defining the inner tube hole for the inner tube 6 to pass therethrough, and the number of the rods depends on the bracket 7
  • the number of proximal perforations 7a depends.
  • the rod 3a and the member 3b defining the inner tube hole may be machined, injection molded or otherwise. It is also possible to connect the wave rod 3a with the member 3b defining the inner tube hole. Methods of attachment include, but are not limited to, welding, gluing, and hot melt.
  • Glues used in the bonding include, but are not limited to, loctite 3011, 3321, 3493, 3494, 3321, 3751; Dymax 203a-cth-f, 204-cth-f, 1201-m-sc, 1128a-m; NuSil MED-2000P; Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE A.
  • the material of the back end jaw 3 may be a metal or a polymer material, and the polymer materials used include, but are not limited to, Pebax, Nylon, PC, PE, PP, ABS.
  • the rear end jaw 3 and the member 3b defining the inner tube hole may be formed as a single member (Fig. 5), wherein the wave rod 3a' of the rear end claw 3 is integrally formed with the member 3b' defining the inner tube hole. It is also possible to separately form and combine the wave rod 3a" of the rear end claw 3 and the member 3b" defining the inner tube hole (Fig. 6), wherein the wave rod 3a" is fixedly coupled to the member defining the inner tube hole, respectively. 3b".
  • the function of the claw guide wire connector 4 is to connect the rear end claw 3 and the control guide wire 5, ensuring that the pull control guide wire 5 can move the rear end claw 3 to the distal end.
  • Realize the back end jaws 3 and control Methods of joining the guide wires 5 include, but are not limited to, welding, gluing, riveting, and hot melting.
  • the glue used for the hot melt and the glue used includes, but is not limited to, loctite 3011, 3321, 3493, 3494, 3321, 3751; Dymax 203a-cth-f, 204-cth-f, 1201-m-sc, 1128a-m; NuSil MED-2000P; Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE A.
  • the jaw wire connector 4 can be integral with the member 3b' defining the inner tube aperture, as shown in FIG.
  • the control wire 5 can be directly attached to the component 3b" defining the inner tube hole, as shown in Figure 6.
  • the connections include, but are not limited to, welding, glue, Riveting, or additionally punching two holes in the part 3b' defining the inner tube hole, wherein the control guide wire 5 passes through the two holes to form a double strand.
  • the distal end of the double-strand control guide wire 5 can be heated Shrink the tube and wrap it up.
  • the rod 3a of the rear end jaw 3 is inserted through the perforation 7a of the proximal end of the bracket 7 of the delivery system into the blind hole 1b of the front end fixture 1, thereby effecting the proximal end of the bracket 7 Bondage.
  • the control guide wire 5 is pulled to separate the rear end jaw 3 from the front end fixture 1 and to move distally.
  • the rod 3a of the rear end claw 3 is pulled out from the perforation 7a of the proximal end of the bracket 7, the proximal end of the bracket 7 is bounced.
  • the procedure for implanting the aortic stent 7 using the delivery system of the present invention is as follows.
  • the bracket 7 is mounted.
  • the rear end claw 3 is inserted into the guide hole 2b of the guide member 2, the proximal end of the bracket 7 is gathered, and then the rear end claw 3 is continuously moved so that all the wave rods 3a thereon pass through the proximal end of the bracket 7.
  • the through hole 7a is inserted into the blind hole 1b on the front end fixing member 1. At this time, the proximal end of the bracket 7 cannot be unfolded due to the restraint of the rod 3a.
  • the second step is to introduce the delivery system.
  • the guide wire 8 is threaded, and then the delivery system is percutaneously punctured through the femoral artery along the guide wire 8 into the abdominal aorta, wherein the stent 7 together with the posterior release assembly has been loaded into the delivery system,
  • the rear release assembly extends longitudinally within the outer sheath tube 10, the inner tube 6 passes through various components of the rear release assembly, and the tapered head 9 of the delivery system is coupled to the front end fastener 1 of the rear release assembly.
  • the delivery system is pushed along the guide wire 8 to the abdominal aortic aneurysm such that the development point (not shown) reaches the position of the abdominal aortic aneurysm, as shown in FIG.
  • the outer sheath tube 10 is withdrawn. After the position is determined, the outer sheath 10 is withdrawn to deploy the body and branches of the stent 7. The proximal end of the stent 7 cannot be deployed because it is still bound by the posterior release component (Fig. 9).
  • the fifth step is to release the proximal end. Fine-tuning the position of the bracket, when the position is finally determined, pulling the control guide wire 5, moving the rear-end claw 3 longitudinally toward the distal end and separating from the front end fixing member 1 until the pole 3a of the rear-end claw 3 is removed from the bracket The proximal end perforation 7a of 7 is pulled out to deploy the proximal end of the stent 7, thereby allowing the stent 7 to be fully released (Fig. 10).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

提供一种支架输送系统及其后释放组件。该后释放组件用于控制血管支架的近端释放，其位于输送系统的近端，该后释放组件从近端（P）到远端（D）按顺序包括前端固定件（1）、后端卡爪（3）和控制导丝（5），后端卡爪（3）的一端与前端固定件（1）可分离地连接，后端卡爪（3）的另一端与控制导丝（5）相连接。通过该后释放组件，血管支架的近端能够在血管支架准确定位后完全释放，从而能够精确控制血管支架的释放。

Description

一种支架输送系统及其后释放组件 技术领域
本发明涉及医疗器械领域，具体涉及主动脉支架的输送系统，用于主动脉瘤(包括主动脉夹层)的介入治疗。本发明还涉及输送系统的后释放组件。
背景技术
主动脉疾病如主动脉瘤、主动脉夹层瘤等是最致命且治疗难度最高的血管外科疾病之一。传统的治疗方法是开放式手术，实施人工血管置换。但是，开放式手术创伤大、病死率高。
近年针对高危主动脉夹层患者开展了一种微创、简捷的介入手术方法，利用覆膜支架对主动脉夹层实施腔内修复术。这种手术通过股动脉的微创切口将覆膜支架经输送系统送到主动脉的病变位置，保护病变血管，修复主动脉病变。
目前用于治疗主动脉瘤大动脉微创介入的输送系统的释放覆膜支架的方式比较简单，即回撤外管，之后支架由于自身的弹性而弹开。这一释放方式在覆膜支架的释放控制方面不够精确，原因是：回撤外管后，覆膜支架直接弹开，而如果覆膜支架的释放位置不正确，则只能通过开放式手术取出覆膜支架，手术创伤大，病死率高。
中国实用新型专利CN202699194U公开了一种分支式腹主动脉覆膜支架及其输送系统。这种分支式腹主动脉覆膜支架包括由记忆合金制成的网管状支架及包覆在该网管状支架上的覆膜，所述网管状支架内的前段部位的台阶上至少设有两袖筒分支，输送系统则包括能伸入所述网管状支架内的释放组件。所述释放组件包括引线和弯折套管，该弯折套管的前端伸入所述网管状支架，且向一侧弯折伸入与其相对应的袖筒分支内，引线的一 端则设置在弯折套管的尾端，另一端伸入弯折套管并与其相对应的袖筒分支相连接。这一输送系统在覆膜支架的释放控制方面仍然不够精确。如果覆膜支架的释放位置不对,则仍只能通过开放式手术取出覆膜支架。
发明内容
鉴于目前用于治疗主动脉瘤大动脉微创介入的输送系统在支架的释放控制方面不够精确，本发明提供了一种输送系统以克服上述问题。根据本发明，支架的近端能够后释放，即回撤外鞘管后，支架处于半释放状态，近端仍然被束缚，这样可以微调支架的位置，从而精确定位支架。
第一方面，本发明提供一种用于输送系统的后释放组件。所述后释放组件位于所述输送系统的近端，所述后释放组件从近端到远端按顺序包括前端固定件、后端卡爪和控制导丝，所述后端卡爪的近端与所述前端固定件可分离地连接，所述后端卡爪的远端与所述控制导丝相连接。以此构造，可实现支架的半释放，即：当支架主体展开后，支架的近端仍被束缚，这样可精确调整支架的位置，待最终确定位置后再释放支架的近端，使支架完全展开。
根据本发明，后端卡爪可以是单个部件，也可以是由若干部件组合而成。后端卡爪的材料可以是高分子或者金属。
优选地，所述后释放组件还包括导向件，所述后端卡爪穿过所述导向件，由所述导向件引导和保持方向。所述导向件的材料可以是高分子材料或者金属。
优选地，所述后释放组件还包括卡爪导丝连接件，所述后端卡爪的所述远端与所述控制导丝经由所述卡爪导丝连接件相连接，所述卡爪导丝连接件的近端与所述后端卡爪固定连接或所述后端卡爪与所述卡爪导丝连接件形成一体，所述卡爪导丝连接件的远端与所述控制导丝固定连接或可活动地连接。所述卡爪导丝连接件的材料也可以是高分子材料或是金属。高 分子材料包括但不限于Pebax,Nylon,PC,PE,PP,ABS。
根据本发明的实施例，所述后端卡爪包括沿周向分布的多根波杆。
根据本发明的实施例，所述后端卡爪还包括限定内管孔的部件，所述内管孔允许所述输送系统的内管穿过，且所述限定内管孔的部件与所述多根波杆相连接或者形成一体。
根据本发明的实施例，所述前端固定件沿周向设有与所述多根波杆相对应的多个盲孔，所述多根波杆分别插入所述多个盲孔内。
根据本发明的实施例，所述导向件沿周向设有与所述多根波杆相对应的多个穿孔，所述多根波杆分别穿过所述多个穿孔。以此构造，所述导向件能够引导和保持后端卡爪每一根波杆的方向，避免交叉或弯曲，并且便于将后端卡爪的多根波杆对准和引入前端固定件的盲孔中。
第二方面，本发明提供一种支架的输送系统，所述输送系统包括外鞘管，内管和支架。所述输送系统还包括上述的后释放组件，用于控制支架的近端释放，所述后释放组件在所述外鞘管内纵向延伸并被所述内管穿过，且所述支架的近端设有穿孔，所述后端卡爪穿过所述穿孔以束缚所述支架的近端。以此构造，后释放组件与近端设孔的支架配合使用，所述后释放组件将支架的近端束缚，使得外鞘管回撤后，支架主体展开，而支架的近端由于被束缚而无法弹开，此时支架可以稍作微调，以实现支架的准确定位，当确认支架的精确位置后，可以通过控制后释放组件将支架的近端放开，从而使支架完全展开。
优选地，所述输送系统还包括位于所述输送系统的近端的锥形头，其与所述前端固定件的近端相连接。
根据本发明的输送系统及后释放组件赋予了支架的近端后释放的功能，使支架的释放更为精准。
附图说明
通过下面参照附图对本发明实施例进行的详细描述，本发明的特征及其优点将是显而易见的。显然，所描述的实施例仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域技术人员在没有做出创造性劳动前提下可以获得所有其它实施例，这些实施例都属于本发明保护的范围。在图中：
图1是根据本发明实施例的后释放组件的示意性透视图。
图2是根据本发明实施例的后释放组件的前端固定件的示意性透视图。
图3是根据本发明实施例的后释放组件的导向件的示意性透视图。
图4是根据本发明实施例的后释放组件的后端卡爪的示意性透视图。
图5是根据本发明另一实施例的后释放组件的后端卡爪的示意性透视图。
图6是根据本发明又一实施例的后释放组件的后端卡爪的示意性透视图。
图7是根据本发明的支架的近端的示意图。
图8-图10是根据本发明实施例的输送系统释放支架的过程的示意图。
具体实施方式
下面参照附图描述本发明的主动脉支架的输送系统的实施例。在以下说明中，为了便于描述，使用了“远端”和“近端”以及“纵向”，“远端”和“近端”参照的分别是接近输送系统的操作端的一侧和远离操作端的一侧，“纵向”参照的是输送系统的延伸方向。
图1显示了根据本发明实施例的后释放组件。如图1所示，所述后释放组件从近端P到远端D按顺序由前端固定件1、导向件2、后端卡爪3、卡爪导丝连接件4、控制导丝5组成。图1还显示了输送系统的内管6，其穿过所述后释放组件的各个部件。
图2显示了前端固定件1。如图2所示，前端固定件1上有内管孔1a 以供内管6穿过，以及沿周向分布的多个盲孔1b，该盲孔的数量与后端卡爪3的波杆3a的数量相对应，以便后端卡爪3的波杆3a插入相应的盲孔1b。前端固定件1的加工工艺可以是注塑模制或机加工等。
图3显示了导向件2。如图3所示，导向件2上有内管孔2a以供内管6穿过，以及沿周向分布的多个导向孔2b。导向孔的数量与后端卡爪3的波杆3a的数量相同，以便后端卡爪3的波杆3a穿过以引导和保持后端卡爪3的每一根波杆3a的方向，避免交叉或弯曲，并且便于将后端卡爪3的波杆3a对准和引入前端固定件1的盲孔1b中。导向件2的加工工艺可以是注塑模制或机加工等。导向件的材料可以是高分子材料或者金属，采用的高分子材料包括但不限于Pebax,Nylon,PC,PE,PP,ABS。
图4-6显示了后端卡爪3。如图4所示，后端卡爪3包括沿周向分布的多个波杆3a，其固定地连接于限定内管孔以供内管6穿过的部件3b，波杆的数量依支架7的近端的穿孔7a(参见图7)的数量而定。可以通过机加工、注塑模制或其它方法加工出波杆3a和限定内管孔的部件3b。也可以将波杆3a和限定内管孔的部件3b连接起来。连接的方法包括但不限于焊接，胶连，热熔。胶连采用的胶水包括但不限于loctite 3011，3321,3493，3494，3321,3751；Dymax 203a-cth-f,204-cth-f,1201-m-sc,1128a-m；NuSil MED-2000P；Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE,TYPE A。后端卡爪3的材料可以是金属或高分子材料，采用的高分子材料包括但不限于Pebax,Nylon,PC,PE,PP,ABS。
后端卡爪3和限定内管孔的部件3b可以制成为单个部件(如图5)，其中后端卡爪3的波杆3a’与限定内管孔的部件3b’一体形成。也可以将后端卡爪3的波杆3a”和限定内管孔的部件3b”分别制成然后组合起来(如图6)，其中波杆3a”分别固定地连接于限定内管孔的部件3b”。
卡爪导丝连接件4的作用是将后端卡爪3和控制导丝5相连接，确保拉动控制导丝5可以带动后端卡爪3向远端移动。实现后端卡爪3与控制 导丝5连接的方法包括但不限于焊接，胶连，铆接，热熔。热熔和采用的胶连采用的胶水包括但不限于loctite 3011，3321,3493，3494，3321,3751；Dymax 203a-cth-f,204-cth-f,1201-m-sc,1128a-m；NuSil MED-2000P；Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE,TYPE A。
卡爪导丝连接件4可以与限定内管孔的部件3b’形成一体，如图5所示。也可以不设单独的卡爪导丝连接件4，而是将控制导丝5直接连接于限定内管孔的部件3b”上，如图6所示。连接包括但不限于焊接，胶连，铆接，或者在限定内管孔的部件3b’上另外打两个孔，其中控制导丝5穿过这两个孔形成双股。为了操作方便，双股控制导丝5的远端可以用热缩管包起来。
在后释放组件中，后端卡爪3的波杆3a穿过输送系统的支架7的近端的穿孔7a插入到前端固定件1的盲孔1b中，由此实现对支架7的近端的束缚。当要释放支架的近端时，拉动控制导丝5，使后端卡爪3与前端固定件1分离并向远端移动。当后端卡爪3的波杆3a从支架7的近端的穿孔7a中拉出后，支架7的近端弹开。
使用本发明的输送系统植入主动脉支架7的过程如下。
第一步，安装支架7。将后端卡爪3穿入导向件2的导向孔2b中，将支架7的近端收拢，然后继续移动后端卡爪3，使其上所有的波杆3a穿过支架7的近端的穿孔7a并插入前端固定件1上的盲孔1b中。此时，由于波杆3a的束缚，支架7的近端无法展开。
第二步，导入输送系统。如图8所示，穿入导引导丝8，接着将输送系统沿导引导丝8经皮穿刺通过股动脉导入腹主动脉，其中支架7连同后释放组件已被装入输送系统内，所述后释放组件在所述外鞘管10内纵向延伸，内管6穿过后释放组件的各个部件，输送系统的锥形头9与后释放组件的前端固定件1相连接。
第三步，将输送系统沿导引导丝8推送至腹主动脉瘤，使显影点(未标出)到达腹主动脉瘤颈的位置，如图8所示。
第四步，回撤外鞘管10。确定好位置后，回撤外鞘管10，使支架7的主体和分支展开。支架7的近端由于仍被后释放组件束缚所以不能展开(如图9)。
第五步，释放近端。微调支架的位置，当最终确定位置后，拉动控制导丝5，使后端卡爪3沿纵向朝远端移动并与前端固定件1分离，直至将后端卡爪3的波杆3a从支架7的近端的穿孔7a中拉出而使支架7的近端展开，由此使支架7被完全释放(如图10)。
最后，撤出输送系统及导引导丝8，完成支架7的植入。
通过所公开的实施例的上述说明，本领域技术人员能够实现或使用本发明。这些实施例的多种修改对本领域的技术人员来讲也将是显而易见的。例如，以上实施例参考的是腹主动脉，但是本发明同样适用于其它的主动脉。本文中所限定的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明不限于本文所示的这些实施例，而是涵盖符合与本文所公开的原理一致的最宽的范围。

Claims (9)

  1. 一种用于输送系统的后释放组件，所述后释放组件位于所述输送系统的近端，其特征在于，所述后释放组件从近端到远端按顺序包括前端固定件、后端卡爪和控制导丝，所述后端卡爪的近端与所述前端固定件可分离地连接，所述后端卡爪的远端与所述控制导丝相连接。
  2. 根据权利要求1所述的后释放组件，其特征在于，所述后释放组件还包括导向件，所述后端卡爪穿过所述导向件，由所述导向件引导和保持方向。
  3. 根据权利要求1所述的后释放组件，其特征在于，所述后释放组件还包括卡爪导丝连接件，所述后端卡爪的所述远端与所述控制导丝经由所述卡爪导丝连接件相连接，所述卡爪导丝连接件的近端与所述后端卡爪固定连接或所述后端卡爪与所述卡爪导丝连接件形成一体，所述卡爪导丝连接件的远端与所述控制导丝固定连接或可活动地连接。
  4. 根据权利要求1或2所述的后释放组件，其特征在于，所述后端卡爪包括沿周向分布的多根波杆。
  5. 根据权利要求4所述的后释放组件，其特征在于，所述后端卡爪还包括限定内管孔的部件，所述内管孔允许所述输送系统的内管穿过，且所述限定内管孔的部件与所述多根波杆相连接或者形成一体。
  6. 根据权利要求4所述的后释放组件，其特征在于，所述前端固定件沿周向设有与所述多根波杆相对应的多个盲孔，所述多根波杆分别插入所述多个盲孔内。
  7. 根据权利要求4所述的后释放组件，其特征在于，所述导向件沿周向设有与所述多根波杆相对应的多个穿孔，所述多根波杆分别穿过所述多个穿孔。
  8. 一种支架的输送系统，所述输送系统包括外鞘管，内管和支架，其 特征在于，所述输送系统还包括根据权利要求1-7中任一项所述的后释放组件，用于控制支架的近端释放，所述后释放组件在所述外鞘管内纵向延伸并被所述内管穿过，且所述支架的近端设有穿孔，所述后端卡爪穿过所述穿孔以束缚所述支架的近端。
  9. 根据权利要求8所述的输送系统，其特征在于，所述输送系统还包括位于所述输送系统的近端的锥形头，与所述前端固定件的近端相连接。
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