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CN102525699B - 分支型支架输送系统及用于其的导引导管 - Google Patents

分支型支架输送系统及用于其的导引导管 Download PDF

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CN102525699B
CN102525699B CN201210008588.6A CN201210008588A CN102525699B CN 102525699 B CN102525699 B CN 102525699B CN 201210008588 A CN201210008588 A CN 201210008588A CN 102525699 B CN102525699 B CN 102525699B
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seal wire
guiding catheter
control
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CN102525699A (zh
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朱清
黄定国
罗七一
高延彬
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Shanghai Minimally Invasive Heart Vein Medical Technology Co., Ltd.
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Minimally Invasive Medical Technology (shanghai) Co Ltd
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Priority to PCT/CN2013/070323 priority patent/WO2013104324A1/zh
Priority to EP13736412.1A priority patent/EP2803340B1/en
Priority to BR112014017341-9A priority patent/BR112014017341B1/pt
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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
    • 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
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/915Stents 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 with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0029Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
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    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
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    • 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
    • A61F2/856Single tubular stent with a side portal passage
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/061Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2/915Stents 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 with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91583Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/018Catheters having a lateral opening for guiding elongated means lateral to the catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0188Introducing, guiding, advancing, emplacing or holding catheters having slitted or breakaway lumens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1045Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M25/0668Guide tubes splittable, tear apart

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

本发明提供一种用于分支型支架输送系统的导引导管及分支型支架输送系统,所述导引导管用来引导分支导丝进入相应的分支血管腔内,以便随后牵引分支型支架的支架分支进入其相应的分支血管腔内,其特征在于,所述导引导管具有沿轴向延伸的至少一个分支导丝管腔,用于引导所述分支导丝,每个分支导丝管腔具有分支导丝入口及相应的分支导丝出口,并且所述导引导管在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿轴向剖开,形成切口,各分支导丝能够通过该切口而离开导引导管。

Description

分支型支架输送系统及用于其的导引导管
技术领域
本发明涉及医疗器械,更具体涉及一种用于外科手术治疗主动脉病变所使用的分支型支架输送系统的导引导管。本发明还涉及包括该导引导管的分支型支架输送系统。
背景技术
在临床上,主动脉瘤有相当一部分涉及到主动脉的多个分支动脉。在传统的治疗中,对患有全程主动脉(包括升主动脉,主动脉弓部,降主动脉和腹主动脉)病变的Stanford A型主动脉夹层病人一般采用正中开胸手术治疗,用人造血管进行升主动脉弓部的替换并在降主动脉真腔中送入一段人造血管(俗称象鼻子),以便为二次手术或二次介入治疗(覆膜支架植入术)作准备。大多数患者一次手术并不能完成治疗,二次手术要从左肋下开胸,手术风险大,费用高,且有一定的衔接难度。这种传统的人工血管置换术极为复杂、创伤非常大、死亡率极高,因而有必要用微创的方法治疗。
近年来出现了一种术中支架,其可有效解决上面所述的二次手术的问题,即:一次手术完成全部治疗。在手术中,通过已切开的主动脉直接将覆膜支架送入不能暴露的降主动脉真腔中,从而达到治疗目的。术中支架上的覆膜材料可与手术中所使用的人造血管缝合在一起,从而完成一套完整的人工血管假体置换系统,达到一次手术完成全部治疗的目的。采用术中支架进行手术,不仅一次手术完成全部治疗,而且缩短了手术时间,减轻了患者的二次手术的痛苦。
中国发明专利申请CN101332133A公开了一种分支型支架或移植物编织装置及其制造方法,其中通过一单个由多根丝进行整体编织而成的织物,其具有一主干部和两个相互铰接的脚。所述脚包括多根丝的全部,而所述主干部包括同一多根丝的一子集。所述制造方法包括在一心轴上编织所述铰接的脚,并保持两铰接的脚之间的线环,以便编织所述支架或移植物的主干。
但是,在目前的胸主动脉及多个分支动脉微创手术中,如何将多分支支架的各分支支架安全而又顺畅地输送到相应的分支血管腔内的病变位置以便安全释放支架是一个难题。
中国发明专利申请CN101897629A涉及一种分支型术中支架输送系统,其公开了单侧支或单分支整体支架的输送。这一输送系统无法解决多分支支架输送过程中的安全释放的问题。在多分支支架的情况下,该系统无法确保多根分支导丝在输送过程不相互缠绕、不干涉以及使各分支导丝顺利进入相应的分支血管腔内。
发明内容
有鉴于此,本发明的目的是解决涉及在胸主动脉及多个分支动脉微创手术中将分支型支架安全而又顺畅地输送到相应的分支血管的病变位置这一难题。
根据本发明第一方面,提供一种用于分支型支架输送系统的导引导管,其用来引导分支导丝顺利地进入相应的分支血管腔内,以便随后安全地牵引分支型支架的支架分支进入相应的分支血管腔内。所述导引导管具有沿轴向延伸的至少一个分支导丝管腔,用于引导所述分支导丝,每个分支导丝管腔具有分支导丝入口及相应的分支导丝出口,并且所述导引导管在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿轴向剖开,形成切口,各分支导丝能够通过该切口而离开导引导管。以此方式,能够在近端与远端同时不能撤回导管的情况下使导管与导丝分离。
通常,分支型支架具有三个支架分支,以用于主动脉的三个分支动脉。因此。导引导管具有三个分支导丝管腔,每个管腔引导一根分支导丝。各管腔彼此互不连通。
导引导管由高分子复合材料或金属材料制成,或者为复合结构的管件。所述导引导管可构成为双层或多层管件,其包括内层管件和外层管件,内外层管件均在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿轴向剖开以形成切口。导引导管也可构成为单个管件。根据本发明,切口为线型,虚刀型或槽型。
或者,导引导管可为组合分体型管件,在管件的分体部分的接合处限定出切口。
优选地,所述导引导管在各分支导丝出口设有显影标记。这样可以便于手术时准确定位。
根据本发明,所述导引导管可还包括沿轴向延伸的控制导丝腔,用于引导控制导丝。
优选地,所述导引导管在控制导丝管腔的延伸上也沿轴向剖开,形成切口,所述控制导丝能够通过该切口而离开所述导引导管。切口可为线型,虚刀型或槽型。
在导引导管为组合分体型管件时,在分体部分的接合处还限定出使所述控制导丝能够通过而离开所述导引导管的切口。
根据本发明第二方面,提供一种分支型支架输送系统,其包括上述的导引导管。
根据本发明,所述分支型支架输送系统还包括操纵手柄、外鞘、分支型支架、用以导入和释放分支型支架的控制导丝及控制开关,所述分支型支架与控制导丝相连并包括至少一个支架分支,且所述系统包括用以牵引支架分支的分支导丝。其中控制操纵手柄和控制开关,使得先将导引导管导入,直至各分支导丝出口对准相应的分支血管,再通过导引导管将分支导丝引导进入相应的分支血管腔内,然后在将分支导丝保留于分支血管腔内的情况下使导引导管与分支导丝分离,之后通过控制导丝将分支型支架导入,使支架分支通过分支导丝而被牵引至其相应的分支血管腔内,最后通过控制导丝释放分支型支架并撤出分支导丝和控制导丝。
根据本发明,导引导管可在与分支导丝分离后撤出,而控制导丝可通过另外的导管单独地导入。
优选地,可控制操纵手柄和控制开关,使得分支导丝和控制导丝均通过导引导管而引导进入相应的主动脉血管腔内和分支动脉血管腔内,然后在将分支导丝和控制导丝保留于各血管腔内的情况下使导引导管与分支导丝和控制导丝分离。
根据本发明,控制导丝和分支导丝可以同时或不同时导入。
根据本发明的导引导管和支架输送系统能确保分支导丝在输送过程不相互缠绕、不干涉,并且能确保各分支导丝顺利而又安全地进入相应的分支血管腔内。而且,根据本发明,先通过导引导管将分支导丝引入分支血管腔内,从而建立了牵引支架分支的通道。以此方式,支架分支可沿已建好的通道安全而又顺畅地输送至其相应的分支血管腔内。
附图说明
图1是根据本发明的支架输送系统和导引导管的构造示意图。
图1A-1B是根据本发明的导引导管的局部放大视图。
图2-2A是单个管件形式的导引导管的示意图和局部放大视图。
图3-3A是双层管件形式的导引导管的示意图和局部放大视图。
图4A-4C是导引导管的切口类型的示意图。
图5A-4C是控制导丝管腔也具有切口的情况下的切口类型的示意图。
图6是组合分体型管件形式的导引导管的示意图。
图7是通过导引导管将分支导丝引入分支血管腔内的示意图。
图8是通过分支导丝将支架分支牵引进入分支血管腔内的示意图。
图9是支架释放后的示意图。
附图标记列表
1操纵手柄
2控制导丝
3控制开关
4外鞘
5、6、7分支导丝
8、8’导引导管
9分支型支架
10、11、12支架分支
20、20’导引导管的锥形头
30分支导丝撤出切口
100、200线型切口
100’、200’虚刀型切口
100”、200”槽型切口
a、b、c分支导丝入口
d、e、f分支导丝出口
具体实施方式
下面结合附图对本发明的具体实施方式进行详细说明。
在以下实施例中,分支型支架具有三个支架分支,用于三个分支动脉。因此,导引导管具有三个分支导丝管腔,每个管腔引导一根分支导丝,以分别牵引三个支架分支。但是,本领域技术人员可以理解,分支导丝管腔的数量可以随着支架分支变化。在只有一个支架分支或两个支架分支的情况下,可以只有一个或两个分支导丝管腔。
而且,在以下实施例中,导引导管具有控制导丝管腔。但是,本领域技术人员可以理解,控制导丝可以通过另外的导管来引导进入主动脉血管腔内。而且,控制导丝和分支导丝可以同时或不同时导入。
另外,为了便于描述,这里使用了术语“远端”和“近端”,离操作端(即操纵手柄1)近的一端为近端,远离操作手柄1的一端为远端。
如图1所示,本发明的支架输送系统包括操作手柄1,控制导丝2,控制开关3,外鞘4,分支导丝5、6、7,导引导管8。外鞘4由PET、PTFE等柔性高分子材料制成。束缚可释放的分支型支架9由外鞘4完全或半完全包裹。作为选择,外鞘4可构成为多层鞘管,如申请人的中国发明专利申请CN101897629A中所述。
支架9具有三个支架分支10、11、12,支架主体和支架分支分别与控制导丝2和分支导丝5、6、7相连,以便被牵引,且支架分支和支架主体均通过操作控制导丝2来释放。通过操纵手柄1和控制开关3,可以对各导丝进行操作。上述是本领域技术人员熟知的。
再来看图1A-1B,如图所示,导引导管8在近端具有三个分支导丝入口a、b、c,在远端具有三个分支导丝出口d、e、f,三根分支导丝5、6、7可从入口导入,从出口导出。出口还设有显影标记(未示出),以便于准确定位。导引导管8由高分子复合材料或金属材料)制成,或构成为复合结构的管件。
如图2-2A所示,导引导管8在远端具有锥形头20,以促进导入主动脉血管,且其在各分支导丝管腔的分支导丝入口和出口之间沿轴向剖开,形成切口。导引导管8还具有控制导丝管腔(未标出),以引导控制导丝2。在该情形中,导引导管8为单个管件。作为选择,导引导管8可为双层管件,如图3-3A所示,其中内外层管件均在各分支导丝管腔的分支导丝入口和出口之间沿轴向剖开,形成切口。图3A标出了分支导丝撤出切口30。
切口可为线型切口100,如图4A所示,可为虚刀型切口100’,如图4B所示,可为槽型切口100”,如图4C所示。虚刀型切口指的是沿导引导管8的轴向形成一系列断续的撕裂线。在使分支导丝与导引导管分离时,可容易地通过打破撕裂线形成贯穿切口。
导引导管8在控制导丝管腔的延伸上也可沿轴向剖开,形成切口,如图5A-5C所示。切口也可为线型切口200,虚刀型切口200’,槽型切口200”。
作为选择,导引导管可以构成为组合分体型管件8’,如图6所示,切口在管件的分体部分的接合处形成。管件8’也具有锥形头20’。
下面参照图7-9对本发明的分支型支架输送系统的操作方法说明如下。首先,将导引导管8从人体髂动脉导入,直至导引导管8的各分支导丝出口d、e、f与相应的分支血管分别对准。分支导丝出口处可以设有显影标记,以便于精确定位。
然后,从导引导管8的各分支导丝入口a、b、c分别导入分支导丝5、6、7,直至分支导丝5、6、7从分支导丝出口d、e、f导出,如图1所示。进一步将分支导丝5、6、7分别导入相应的分支血管腔内,如图7所示。控制导丝2可以通过导引导管8与分支导丝同时导入。
然后,保留分支导丝5、6、7在相应的分支血管腔内,同时使分支导丝5、6、7通过相应的切口而与导引导管8与分离,以便将导引导管8撤出体外。由此,分支导丝到达期望的血管位置,而不会相互缠绕和干涉。控制导丝2也可通过相应的切口而与导引导管8与分离。
然后,通过分支型支架的导管和控制导丝2将分支型支架9输送到位,其中使支架分支10、11、12通过分支导丝5、6、7而被牵引至相应的分支血管腔内,如图8所示。
之后,通过控制导丝2释放分支型支架9,之后撤出各分支导丝5、6、7和控制导丝2,如图9所示。分支导丝可从主动脉分支血管穿出,从远端撤出。最后将外鞘4撤出体外,完成支架植入手术。
通过本发明的导引导管8,确保了多根分支导丝5、6、7在输送过程不相互缠绕、不干涉,并且能确保分支导丝进入相应的分支血管腔。而且,支架分支沿着分支导丝已建好的通道引入,由此使分支型支架9安全、顺畅输送至主动脉血管及多个分支动脉血管的病变位置,并将支架9安全地释放。
本发明所提供的导引导管及输送系统不仅适合用于主动脉分支型支架的输送,也适合用于其他血管的分支型支架的输送。
本发明决不局限于上述具体实施方式中所描述的具体内容。本领域技术人员可以想到其它变型、修改和增加,而不会离开本发明的范围。

Claims (3)

1.一种分支型支架输送系统,其特征在于,所述分支型支架输送系统包括导引导管(8),其用来引导分支导丝(5、6、7)进入相应的分支血管腔内,以便随后牵引分支型支架(9)的支架分支(10、11、12)进入其相应的分支血管腔内,其特征在于,所述导引导管(8)具有沿轴向延伸的至少一个分支导丝管腔,用于引导所述分支导丝(5、6、7),每个分支导丝管腔具有分支导丝入口(a、b、c)及相应的分支导丝出口(d、e、f),并且所述导引导管(8)在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿轴向剖开,形成切口,各分支导丝(5、6、7)能够通过该切口而离开导引导管(8)。
2.如权利要求1所述的分支型支架输送系统,其还包括操纵手柄(1)、外鞘(4)、分支型支架(9)、用以导入和释放分支型支架(9)的控制导丝(2)及控制开关(3),所述分支型支架(9)与控制导丝(2)相连并包括至少一个支架分支(10,11,12),且所述系统包括用以牵引支架分支(10、11、12)的分支导丝(5、6、7),其中控制操纵手柄(1)和控制开关(3),使得先将导引导管(8)导入,直至各分支导丝出口对准相应的分支血管,再通过导引导管(8)将分支导丝(5、6、7)引导进入相应的分支血管腔内,然后在将分支导丝保留于分支血管腔内的情况下使导引导管(8)与分支导丝(5、6、7)分离,之后通过控制导丝(2)将分支型支架(9)导入,使支架分支(10、11、12)通过分支导丝(5、6、7)而被牵引至其相应的分支血管腔内,最后通过控制导丝(2)释放分支型支架(9)并撤出分支导丝(5、6、7)和控制导丝(2)。
3.如权利要求2所述的分支型支架输送系统,其中,控制操纵手柄(1)和控制开关(3),使得分支导丝(5、6、7)和控制导丝(2)均通过导引导管(8)而引导进入相应的血管腔内,然后在将分支导丝和控制导丝保留于血管腔内的情况下使导引导管(8)与分支导丝(5、6、7)和控制导丝(2)分离。
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