CN106214287A - Covered stent for aortic dissection surgery, conveying device and use method - Google Patents

Covered stent for aortic dissection surgery, conveying device and use method Download PDF

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Publication number
CN106214287A
CN106214287A CN 201610721152 CN201610721152A CN106214287A CN 106214287 A CN106214287 A CN 106214287A CN 201610721152 CN201610721152 CN 201610721152 CN 201610721152 A CN201610721152 A CN 201610721152A CN 106214287 A CN106214287 A CN 106214287A
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stent
body
left
artery
graft
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CN 201610721152
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Chinese (zh)
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杨威
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杨威
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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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61F2/95Instruments 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
    • 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
    • A61F2002/9505Instruments 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
    • A61F2002/9511Instruments 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 the retaining means being filaments or wires

Abstract

The invention discloses a covered stent for aortic dissection surgery, a conveying device and a use method. The stent comprises a body which is a covered stent body. The stent is a conical stent with the diameter gradually reduced from the cardiac proximal portion to the thoracic aorta distal portion. An exposed portion is arranged on the lower portion of the body of the stent and is not covered. Three balloon dilatation stents are connected to the upper edge of the middle of the body. A protective gasket made from polytetrafluoroethylene is arranged at the near end of the body. The three balloon dilatation stents are provided with three catheters respectively. Each catheter is about 2 m long. The conveying device comprises a conveying sheath, the body of the stent is compressed in the conveying sheath, and the three balloon dilatation stents on the middle section of the body are compressed in the conveying sheath. A conveying sheath system is provided with an apex, and notches are formed in the tip end of the conveying sheath system for the body of the stent and guide wires and the catheters of the three balloon dilatation stents. The invention provides the covered stent for aortic dissection surgery. The stent is used for minimally invasive surgery treatment of Stanford A type aortic dissection with a wound among three branch vessels on the arcus aortae, avoids injuries caused by thoracotomy, and can be directly used for intra-cardiac wound occlusion.

Description

主动脉夹层手术用覆膜支架、输送装置以及使用方法 Surgical aortic dissection with a stent delivery device and methods of use

技术领域 FIELD

[0001]本发明涉及医疗器械领域,具体涉及一种主动脉夹层手术用覆膜支架及其使用方法。 [0001] The present invention relates to the field of medical devices, particularly, to a surgical dissection with a stent and method of use.

背景技术 Background technique

[0002] 对于破口位于主动脉弓上三分支血管间的Stanford A型主动脉夹层,不适合采用传统的覆膜支架置入主动脉腔内修复术,此方法会堵住主动脉弓三个分支的开口,影响头部血供,造成大面积脑梗。 [0002] For the break in the aortic arch Stanford A aortic dissection among the three branch vessel, is not suitable for traditional endovascular aortic stent implantation repair, this method will block the opening of the three branches of the aortic arch, the impact of the head blood supply, resulting in a large area of ​​the brain stem. 故目前的手术方式为开胸手术,在体外循环下,用人工血管置换病变的主动脉弓。 Therefore, the current surgical approach to thoracic surgery under cardiopulmonary bypass, aortic arch replacement with artificial blood vessels. 此法创伤大,很多身体状态差的病人不耐受开胸手术,且在体外循环手术人工血管和自体血管吻合点出血的问题,术中脑保护及重要脏器保护的问题复杂,这是容易造成患者术后死亡的原因之一。 This method trauma, a lot of poor physical condition of the patient does not tolerate open heart surgery and cardiopulmonary bypass surgery at the problem of artificial blood vessels and vascular anastomosis from the point of bleeding, surgery complicated cerebral protection and the protection of vital organs of the problem, it is easy one of the reasons patients after death.

发明内容 SUMMARY

[0003]本发明要解决的技术问题是:提供一种胸主动脉覆膜支架、输送装置及其使用方法,可使部分必须开胸手术的破口位于主动脉弓上三分支血管间的Stanford A型主动脉夹层的病人,通过微创介入手术完成治疗。 [0003] The present invention is to solve the technical problem are: to provide a thoracic aortic stent-graft delivery apparatus and method of use, can be partially positioned on thoracic surgery rupture aortic arch for Stanford A among the three branch vessel aortic dissection patients through minimally invasive surgery to complete the treatment.

[0004]为了解决上述技术问题,本发明提供了一种主动脉夹层手术用覆膜支架,该支架包括锥形的主体,该主体头部为靠近心脏的近端,尾部为靠近主动脉的远端,头部至尾部直径大小逐渐呈递减趋势,该主体的上部对应于头部、下部对应于腹部设置,且所述主体下部设有裸露部,所述主体的外层除该裸露部外均有覆膜结构,主体中部的上缘设有多个球囊扩张支架。 [0004] To solve the above problems, the present invention provides a surgical dissection with a stent, the stent comprising a tapered body, the head body near the proximal end of the heart, near the aorta distal to the tail end, head to tail diameter gradually decreasing trend, the upper portion of the body corresponding to the head portion, a lower portion disposed corresponding to the abdomen, and the exposed portion of the lower body is provided with, in addition to the outer layer of the body portion are exposed there film structure, the upper edge of the central body is provided with a plurality of balloon-expandable stent.

[0005]进一步,所述裸露部位于所述主体下缘,裸露部分面积约为支架上覆膜面积的I/4。 [0005] Further, the exposed portion of the body located at the lower edge, the exposed part of the area covered area about the holder I / 4.

[0006]进一步,所述球囊扩张支架设有3个。 [0006] Further, the balloon expandable stent has three.

[0007]进一步,所述覆膜支架沿轴向设置有多个波浪形的圆环。 [0007] Further, the stent-graft is provided with a plurality of wavy annular axially.

[0008]进一步,所述覆膜支架为医用高分子材料。 [0008] Further, the stent-graft is a medical polymer materials.

[0009]进一步,所述球囊扩张支架长为3cm,还连接有30cm球囊扩张支架导管,该球囊扩张支架导管的前30cm为交换导管。 [0009] Further, the balloon expandable stent length 3cm, is also connected to 30cm catheter balloon expandable stent, the balloon expandable stent catheter exchange catheter prior to 30cm.

[0010]进一步,所述覆膜支架主体近端带有膨体材料做成的保护性垫片。 [0010] Further, the proximal end of the stent-graft body with a protective pad made of expanded material.

[0011]本发明公开的另一种技术方案在于:一种主动脉夹层手术用覆膜支架的输送装置,其包括输送鞘管,约束覆膜支架的缝线和牵拉导丝,缝线缝制在支架主体的外侧面上,缝线将左锁骨下动脉近端覆膜支架两个侧边缝合上,牵拉导丝通过缝线将支架收拢于半收缩状态,将覆膜支架收拢并被包裹于输送鞘管内;其特征在于,所述输送鞘管的头部为尖顶形状,所述牵拉导丝近端穿过缝线使支架近端呈半收缩状态,牵拉导丝的远端穿过输送鞘管的手柄处穿出并固定。 [0011] Another aspect of the present invention is disclosed wherein: one kind of surgical dissection stent graft delivery device, comprising a delivery sheath, and pulling the suture restraint guidewire stent graft, a suture seam made in the outer surface of the stent body, suture the artery proximal to the left subclavian stent-graft suture two sides, pulling the guide wire stent by a suture in a semi collapsed contracted state, and the collapsed stent-graft conveying the wrapped sheath; wherein the delivery sheath head portion of the spire shape, pulling the suture through the proximal end of the guidewire proximal end of the stent in a semi-collapsed state, pulling the distal end of the guidewire through the handle of the delivery sheath and piercing fixed.

[0012]进一步,所述的手柄处设有中控的线槽和可分离的插头,输送鞘管上的牵拉导丝从线槽中穿过,牵拉导丝的远端连接固定在插头上。 [0012] Further, the handle is provided in the duct and controlled separable plug, pulling on the guide wire from the delivery sheath through the slot, pulling the distal end of the guidewire is fixed to the plug connector on.

[0013]本发明公开的再一种技术方案在于:一种主动脉夹层手术用覆膜支架的使用方法,包括如下步骤: [0013] Yet another aspect of the present invention is disclosed wherein: one kind of use of the surgical dissection of the stent-graft, comprising the steps of:

[0014] S1:手术前,将覆膜支架压缩在输送装置内; [0014] S1: before surgery, stent graft compressed in the conveying means;

[0015] S2:开始手术,第一步:分别手术游离左、右侧肱动脉,左侧颈外动脉及一侧股动脉备用;第二步:在DSA指引下,将4根导丝从下肢一侧股动脉穿入,其中一根超硬导丝穿到升主动脉,余3根0.018cm*2.6m导丝分别从左上肢肱动脉、右上肢肱动脉、左颈外动脉穿出;第三步:4根导丝尾部分别穿入相应4个导管,输送鞘管中间穿入的是超硬导丝,右侧肱动脉导丝远端穿入的是头臂干动脉球囊扩张支架导管,左侧颈外动脉导丝远端穿入的是左侧颈总动脉球囊扩张支架导管,左侧肱动脉导丝远端穿入的是左侧锁骨下动脉球囊扩张支架导管,导管沿着导丝前行并分别从左右肱动脉,左侧颈外动脉拉出体外;第四步,在放射线下观察,覆膜支架输送系统送达主动脉弓预定位置时,同时牵拉三根导管,使其同步到达主动脉弓的位置;第五步:输送覆膜支架到达主动脉弓位置 [0015] S2: start operation, the first step: free operation respectively left and right brachial artery, the left external carotid artery and the femoral artery standby; Step: In DSA guidance, the guide wire 4 from the lower extremities penetrate the femoral artery, through which a super-hard wire to the ascending aorta, I 3, respectively 0.018cm * 2.6m guidewire upper left brachial artery, brachial artery right arm, left external carotid artery piercing; first three steps: a guide wire 4 into the corresponding tails are four conduits, delivery sheath penetrated superhard intermediate tube guidewire, the distal end of the guidewire right brachial artery is penetrated brachiocephalic artery balloon catheter stent , the left external carotid artery guidewire distal end to penetrate the left carotid artery catheter balloon expandable stent, the distal end of the guidewire left brachial artery is penetrated by a balloon expandable stent left subclavian catheter, the catheter along a the guidewire and forward respectively from the left and right brachial artery, the left external carotid artery drawn in vitro; the fourth step, viewed in the radiation, stent-graft delivery system delivery aortic arch predetermined position, while pulling three conduits, so synchronization to the position of the aortic arch; fifth step: transporting the stent-graft reaches the position of the aortic arch 后,由近端到远端逐步解除支架束缚;第六步:调整覆膜支架位置,将三个球囊扩张支架对准并进入主动脉弓的头臂干动脉、左颈总动脉、左锁骨下动脉三个分支开口,牵拉左右上肢的导管及左侧颈外动脉导管,使之进入相应的动脉;第七步:扩张左颈总动脉内球扩支架,同步牵拉左右上肢对应的头臂干动脉、左锁骨下动脉导管,覆膜支架主体在主动脉弓内固定;第八步:扩张头臂干动脉支架;第九步:再扩张左锁骨下动脉支架;最后,逐渐释放直径较细的远端,覆膜支架支撑体自行弹开全部释放; After release from the proximal end to the distal end of the stent gradually to be bound; a sixth step: adjusting the position of the stent-graft, balloon-expandable stent the three aligned into the brachiocephalic artery and the aortic arch, common carotid artery, left subclavian artery three branch openings, pulling the outer catheter around the upper limb and the left carotid artery catheter into the respective arteries so; seventh step: left common carotid artery dilation ball expanding stent, the synchronization pull upper left brachiocephalic corresponding artery, the left subclavian artery catheters, stent graft body secured within the aortic arch; eighth step: brachiocephalic artery stent expansion; step 9: re-expansion of the stent left subclavian artery; Finally, the gradual release of smaller diameter of the distal the stent graft self-supporting body bounce fully released;

[0016] S3:撤出输送鞘,再次升主动脉造影,缝合手术切口,完成手术。 [0016] S3: withdrawal of the delivery sheath, ascending aorta, suture the incision once again to complete the operation.

[0017]本发明的技术效果在于:本发明的覆膜支架为带垫片的“锥形”支架,支架的形状符合人体血管结构特征,利于支架与血管的紧密贴合,膨体材料做成的垫片可以防止支架边缘刺破血管,同时防止近心端一型内漏的发生。 [0017] A technical effect of the present invention is that: the present invention is a stent graft, with the gasket in the shape of "cone" vascular stent stent in line with the body structural feature, the stent facilitates close contact with the blood vessel, made of expanded material the spacer may prevent the stent edges vascular puncture, while preventing the proximal ends of the occurrence of a leakage type. 支架的主体下部设有裸露部不覆膜,不仅使支架近端半释放状态时血液可透过不覆膜的支架,保证主动脉弓远端的分支血管的血供;而且在三个球囊扩张支架进入弓上三个分支血管时减少血流冲击,保证覆膜支架在未释放完全时在主动脉弓内的稳定。 A lower body frame exposed portion is not provided with the coating film, not only the proximal end of the stent-release state when the blood is not permeable film holder, to ensure the blood supply branch vessel distal aortic arch; balloon expandable stent and in three reduce the impact of blood flow entering the three branches of blood vessels on the bow, to ensure the release of the stent-graft is not stable in the aortic arch was complete. 支架足够柔软符合血管结构特征,可不损伤血管。 Flexible enough to meet the vascular stent structural features, may damage blood vessels. 支架主体中部的上缘连接三个球囊扩张支架,可以分别对破口位于主动脉弓上三分支血管间的Stanford A型主动脉夹层实施封堵,同时保证主动脉弓上三分支血管的供血,从而能对破口位于主动脉弓上三分支血管间的Stanford A型主动脉夹层进行微创治疗。 The upper edge of the body frame connecting middle three balloon expandable stent, can be separately break in the aortic arch embodiment occluder for Stanford A aortic dissection among the three branch vessel, while maintaining three blood vessels of the aortic arch branches, which can pair break in Stanford a aortic dissection among the three branch vessel minimally invasive treatment of aortic arch. 支架为镍钛合金材料,手术过程中可以在放射线下观察到,能保证与血管准确对位,防止释放位置错误,封堵住分支血管。 Nickel titanium alloy stent, a surgical procedure can be observed under the radiation, to ensure accurate alignment with the vessel, preventing the release position error, branch vessel closure blocked.

附图说明 BRIEF DESCRIPTION

[0018]图1是本发明主动脉夹层手术用覆膜支架的结构示意图; [0018] FIG. 1 is a schematic view of the present invention aortic dissection surgery structural stent-graft;

[0019]图2是本发明主动脉夹层手术用覆膜支架以及三个球囊扩张支架的示意图。 [0019] FIG. 2 is a schematic view of the surgical dissection of the present invention with a stent and three balloon expandable stent.

[0020]图3是本发明主动脉夹层手术用覆膜支架球囊扩张支架的结构示意图; [0020] FIG. 3 is a schematic view of the surgical dissection of the present invention with a stent balloon expandable stent;

[0021]图4为本发明主动脉夹层手术用覆膜支架的输送装置结构示意图; [0021] FIG. 4 is a schematic view of the structure of a stent graft delivery device aortic dissection surgery invention;

[0022]图5是本发明主动脉夹层手术用覆膜支架置入病变部位导丝需经过的人体动脉系统示意图; [0022] FIG. 5 is a schematic view of the surgical dissection of the arterial system of the present invention into the body subject to lesions of the guidewire with a stent;

[0023]图6是本发明主动脉夹层手术用覆膜支架输送装置经过人体动脉系统示意图。 [0023] FIG. 6 is a schematic view of the inventive surgical dissection of the arterial system through the body with a stent delivery device.

具体实施方式 detailed description

[0024]下面结合附图和具体实施例对本发明作进一步说明,以使本领域的技术人员可以更好的理解本发明并能予以实施,但所举实施例不作为对本发明的限定。 [0024] conjunction with the accompanying drawings and specific embodiments of the present invention will be further described, to enable those skilled in the art may better understand the present invention and can be implemented, but the cited embodiments not limit the present invention.

[0025]如图1所示,为本发明主动脉夹层手术用覆膜支架的结构1,该支架I包括锥形的主体,该主体头部10为靠近心脏的近端,尾部11为靠近主动脉的远端,头部10至尾部11直径大小逐渐呈递减趋势,该主体的上部12对应于头部、下部对应于腹部设置,且主体下部设有裸露部13,主体的外层除该裸露部13均有覆膜结构,所述裸露部位于所述主体下缘,裸露部分面积约为支架上覆膜面积的1/4,覆膜支架为预凝的医用高分子材料。 [0025] FIG. 1, the present invention is a tapered body structure of the surgical dissection of the stent graft 1, the stent comprising I, the head body 10 near the proximal end of the heart, close to the tail portion 11 of the main artery distal head 10 to the tail 11 diameter gradually decreasing trend, the upper portion of the main body 12 corresponding to the head portion, a lower portion provided corresponding to the abdomen, and the exposed portion 13 is provided with a lower body, the outer body of the other exposed Each film structure portion 13, the exposed portion of the body located at the lower edge, an area of ​​about 1/4 of the exposed portion of the stent coating area, medical polymer materials for the presetting of the stent-graft. 主体中部的上缘设有多个球囊扩张支架14,本实施例中球囊扩张支架14共设有3个,分别对应左上肢肱动脉、右上肢肱动脉、左颈外动脉设置,覆膜支架I沿轴向设置有多个波浪形的圆环15。 The upper edge of the central body is provided with a plurality of balloon-expandable stent 14, a balloon expandable stent embodiment 14 of the present embodiment is provided with three, respectively upper left brachial artery, brachial artery right arm, left external carotid artery is provided, the coating film a plurality of wavy annular bracket 15 I disposed in the axial direction. 覆膜支架I主体近端带有膨体材料做成的保护性垫片。 I stent graft body proximal end with a protective pad made of expanded material. 球囊扩张支架14长为3cm,还连接有30cm球囊扩张支架导管16,该球囊扩张支架导管16的前30cm为交换导管。 Balloon-expandable stent 14 length 3cm, is also connected to conduit 16 30cm balloon expandable stent, the balloon expandable stent catheter 16 before catheter exchange of 30cm.

[0026]如图4、5所示,为本发明主动脉夹层手术用覆膜支架的输送装置2,包括输送鞘管22,支架I主体被压缩在输送鞘管22内,主体中段上的三个带球囊的支架14被压缩在输送鞘管22内;输送鞘管33系统具有尖顶21,支架主体及三个球囊扩张支架14的导丝23和导管16开槽于输送鞘管系统2的尖端。 [0026] As shown in FIG 4, 5, aortic dissection surgical delivery device with a stent of the present invention 2, comprising a delivery sheath 22, the stent body is compressed in I delivery sheath 22, the three middle body a stent with a balloon 14 is compressed in a delivery sheath 22; delivery sheath 33 having a steeple system 21, wire holder body 14 and three balloon expandable stent 23 and the slot 16 in the delivery catheter sheath system 2 tip. 主动脉夹层手术用覆膜支架I的输送装置2,其包括输送鞘管22,缝线和牵拉导丝23,缝线缝制在支架主体的外侧面上22上,缝线将左锁骨下动脉近端覆膜支架I两侧边缝合上,牵拉导丝23通过缝线将支架收拢于半收缩状态,将覆膜支架I收拢并被包裹于输送鞘管22内;输送鞘管22的头部为尖顶21,牵拉导丝23近端穿过缝线使支架I近端呈半收缩状态,牵拉导丝23的远端穿过输送鞘管22的手柄处穿出并固定。 Surgical dissection I stent graft delivery device 2, comprising a delivery sheath 22, and pull the suture guide wire 23, on the outside surface of the stent body 22, the left subclavian suture stitches sewn coating both sides of the artery proximal stent I suture, the suture is pulled by the guide wire 23 to a semi-collapsed stent contracted state, I collapsed stent graft in the delivery sheath and the inner wrap 22; delivery sheath 22 head for the steeple 21, pulling the suture through the proximal end of the guide wire 23 proximal of the stent in a semi-collapsed state I, the distal end of the guidewire 23 is pulled through the handle of the delivery sheath 22 and fixed to the piercing. 手柄24处设有中控的线槽和可分离的插头,输送鞘管22上的牵拉导丝从线槽中穿过,牵拉导丝23的远端连接固定在插头上。 The handle 24 is provided in the control slot and a detachable plug, pulling the delivery sheath on the guide wire 22 from passing through the slot, pulling the distal end of the guide wire 23 is connected and fixed to the plug. 输送鞘管22采用聚酯、聚四氟乙烯或其衍生物中的一种材料制作。 Delivery sheath 22 of polyester, polytetrafluoroethylene or a derivative of a material produced.

[0027]本发明的支架I必须要借助与之匹配的支架输送装置2,才能植入到相应的主动脉病变位置,即利用输送装置2将覆膜支架约束于输送鞘管22内,然后输送到主动脉弓分支血管的病变位置后将支架I释放,最后将输送装置撤出。 [0027] The stent of the present invention, I must be using the stent delivery device matching 2, in order to implant the aortic lesion position corresponding to, i.e., use of the stent graft delivery device 2 constrained to the delivery sheath 22 and then conveyed after the stent to the aortic arch lesion position I to release the branch vessels, and finally the withdrawal of the delivery device. 第一步,分别手术游离左、右侧肱动脉,左侧颈外动脉及一侧股动脉备用。 The first step, namely the free surgery left and right brachial artery, the left external carotid artery and the femoral artery standby. 第二步,在DSA指引下,将4根导丝(其中I根为超硬导丝231,另外三根为0.018cm*2.6m导丝232、233、234)从下肢一侧股动脉穿入,超硬导丝231穿到升主动脉,余3根导丝232、233、234分别从右上肢肱动脉、左颈外动脉、左上肢肱动脉穿出。 The second step in the DSA guidance, the guide wire 4 (wherein I is a super-hard wire root 231, the other three of 0.018cm * 2.6m guidewire 232,233,234) penetrating from one side of the femoral artery of lower extremity, cemented to the guidewire 231 through the ascending aorta, over a guide wire 3 232,233,234 respectively upper right brachial artery, left external carotid artery, brachial artery left upper piercing. 第三步,4根导丝尾部分别穿入相应4个导管,输送鞘管22中间穿入的是超硬导丝231,右侧肱动脉导丝232远端穿入的是头臂干动脉球囊扩张支架导管,左侧颈外动脉233导丝远端穿入的是左侧颈总动脉球囊扩张支架导管,左侧肱动脉导丝234远端穿入的是左侧锁骨下动脉球囊扩张支架的导管。 The third step, four tails each guidewire into the corresponding conduits 4, 22 intermediate the delivery sheath penetrated superhard guidewire 231, right brachial artery 232 distal end of the guidewire is penetrated ball brachiocephalic artery catheter balloon expandable stent, the left external carotid artery 233 distal end penetrated the guidewire is left common carotid artery catheter balloon expandable stent, the left brachial artery 234 distal end penetrated the guidewire is left subclavian artery balloon dilation catheter stent. 导管沿着导丝前行并分别从左右肱动脉,左侧颈外动脉拉出体夕卜。 Catheter guide wire along the front and, respectively, from left brachial artery, the left external carotid artery Bu Xi drawer body. 第四步,在放射线下观察,覆膜支架输送系统2送达主动脉弓预定位置时,牵拉三根导管,使其同步到达主动脉弓的位置;第五步:输送覆膜支架到达主动脉弓位置后,由近端到远端逐步解除支架束缚;第六步:调整覆膜支架I位置,将三个球囊扩张支架14对准并进入主动脉弓的头臂干动脉、左颈总动脉、左锁骨下动脉三个分支开口,牵拉左右上肢的导管及左侧颈外动脉导管,使之进入相应的动脉;第七步:扩张左颈总动脉内球扩支架,同步牵拉左右上肢对应的头臂干动脉、左锁骨下动脉导管,覆膜支架主体I在主动脉弓内固定;第八步:扩张头臂干动脉支架;第九步:再扩张左锁骨下动脉支架;最后,逐渐释放直径较细的远端,覆膜支架支撑体自行弹开全部释放。 A fourth step, viewed in the radiation, stent-graft delivery system 2 when made aortic arch predetermined position, pulling three conduits, it reaches the position of the synchronization of the aortic arch; Step 5: delivery stent-graft reaches the position of the aortic arch, near the gradually releasing the stent distal end to be bound; a sixth step: adjusting the position of the stent-graft I, the three balloon expandable stent 14 is aligned into the brachiocephalic artery and the aortic arch, common carotid artery, left subclavian artery three branch opening, pulling the outer catheter around the carotid artery catheter and the left upper limb, so as to enter the corresponding artery; seventh step: left common carotid artery dilation ball expanding stent, the synchronization pull brachiocephalic artery around the corresponding limb, arterial catheter, stent graft body I fixed the left subclavian within the aortic arch; eighth step: brachiocephalic artery stent expansion; step 9: re-expansion of the stent left subclavian artery; Finally, the gradual release of smaller diameter of the distal, self-supporting body bounce stent-graft fully released.

[0028]以上所述实施例仅是为充分说明本发明而所举的较佳的实施例,本发明的保护范围不限于此。 Preferred embodiments are merely examples of the present invention is fully described and cited [0028] The above-described embodiments, the scope of the present invention is not limited thereto. 本技术领域的技术人员在本发明基础上所作的等同替代或变换,均在本发明的保护范围之内。 Equivalents or converting skilled in the art on the basis of the present invention is made, it is within the scope of the present invention. 本发明的保护范围以权利要求书为准。 The scope of the present invention in claims and their equivalents.

Claims (10)

  1. 1.一种主动脉夹层手术用覆膜支架,其特征在于,该支架包括锥形的主体,该主体头部为靠近心脏的近端,尾部为靠近主动脉的远端,头部至尾部直径大小逐渐呈递减趋势,该主体的上部对应于头部、下部对应于腹部设置,且所述主体下部设有裸露部,所述主体的外层除该裸露部外均有覆膜结构,主体中部的上缘设有多个球囊扩张支架。 An operation for aortic dissection, characterized in that with a stent, the stent comprising a tapered body, the head body near the proximal end of the heart, near the aorta distal to the tail, the diameter of the head to the tail size gradually decreasing trend, the upper portion of the body corresponding to the head portion, a lower portion disposed corresponding to the abdomen, and the exposed portion is provided with a lower body, the body outer layer has a film structure, in addition to the central body portion exposed a plurality of upper edge of the balloon-expandable stent.
  2. 2.根据权利要求1所述的主动脉夹层手术用覆膜支架,其特征在于,所述裸露部位于所述支架主体下缘,裸露部分面积约为支架上覆膜面积的1/4。 The aortic dissection procedure according to claim 1 with a stent, wherein the exposed portion of the stent body positioned lower edge, the exposed part of the coating on the stent an area of ​​about 1/4 of the area.
  3. 3.根据权利要求1所述的主动脉夹层手术用覆膜支架,其特征在于,所述球囊扩张支架设有3个。 3. The surgical dissection of claim 1 with a stent, wherein the balloon expandable stent has three.
  4. 4.根据权利要求1所述的主动脉夹层手术用覆膜支架,其特征在于,所述覆膜支架沿轴向设置有多个波浪形的圆环。 The aortic dissection procedure according to claim 1 with a stent, wherein said stent graft is provided with a plurality of wavy annular axially.
  5. 5.根据权利要求1所述的主动脉夹层手术用覆膜支架,其特征在于,所述覆膜支架为医用高分子材料。 The aortic dissection procedure according to claim 1 with a stent, wherein said stent graft is a medical polymer materials.
  6. 6.根据权利要求3所述的主动脉夹层手术用覆膜支架,其特征在于,所述球囊扩张支架长为3cm,还连接有30cm球囊扩张支架导管,该球囊扩张支架导管的前30cm为交换导管。 The surgical dissection of the stent-graft according to claim 3, wherein the balloon expandable stent length 3cm, is also connected to 30cm catheter balloon expandable stent, the balloon expandable stent prior to catheter 30cm exchange catheter.
  7. 7.根据权利要求1所述的主动脉夹层手术用覆膜支架,其特征在于,所述覆膜支架主体近端带有膨体材料做成的保护性垫片。 The aortic dissection procedure according to claim 1 with a stent, wherein said stent graft body proximal end with a protective pad made of expanded material.
  8. 8.根据一种权利要求1-7任一项所述主动脉夹层手术用覆膜支架的输送装置,其包括输送鞘管,约束覆膜支架的缝线和牵拉导丝,缝线缝制在支架主体的外侧面上,缝线将左锁骨下动脉近端覆膜支架两个侧边缝合上,牵拉导丝通过缝线将支架收拢于半收缩状态,将覆膜支架收拢并包裹于输送鞘管内;其特征在于,所述输送鞘管的头部为尖顶形状,所述牵拉导丝近端穿过缝线使支架近端呈半收缩状态,牵拉导丝的远端穿过输送鞘管的手柄处穿出并固定。 8. The surgical 1-7 an aortic dissection with a stent delivery device in accordance with one of the preceding claims, comprising a delivery sheath, and pulling the suture restraint guidewire stent graft, a suture sewn in the outer surface of the stent body, suture the artery proximal end of the stent-graft suture two sides, pulling the guide wire stent by a suture folded in half left subclavian contracted state, the collapsed stent-graft and wrapped in conveying the sheath; wherein the delivery sheath head portion of the spire shape, pulling the suture through the proximal end of the guidewire proximal end of the stent in a semi-collapsed state, the distal end of the guidewire is pulled through the the handle of the delivery sheath and piercing fixed.
  9. 9.根据权利要求8所述的输送装置,其特征在于,所述的手柄处设有中控的线槽和可分离的插头,输送鞘管上的牵拉导丝从线槽中穿过,牵拉导丝的远端连接固定在插头上。 9. The delivery device according to claim 8, wherein said handle is provided in the duct and controlled separable plug, pulling on the guide wire from the delivery sheath through the slot, pulling the distal end of the guidewire is secured to the plug connector.
  10. 10.根据权利要求1-7任一项所述的一种主动脉夹层手术用覆膜支架的使用方法,其特征在于,包括如下步骤: 51:手术前,将覆膜支架压缩在输送装置内; 52:开始手术,第一步:分别手术游离左、右侧肱动脉,左侧颈外动脉及一侧股动脉备用;第二步:在DSA指引下,将4根导丝从下肢一侧股动脉穿入,其中一根超硬导丝穿到升主动脉,余3根0.018cm*2.6m导丝分别从左上肢肱动脉、右上肢肱动脉、左颈外动脉穿出;第三步:4根导丝尾部分别穿入相应4个导管,输送鞘管中间穿入的是超硬导丝,右侧肱动脉导丝远端穿入的是头臂干动脉球囊扩张支架导管,左侧颈外动脉导丝远端穿入的是左侧颈总动脉球囊扩张支架导管,左侧肱动脉导丝远端穿入的是左侧锁骨下动脉球囊扩张支架导管,导管沿着导丝前行并分别从左右肱动脉,左侧颈外动脉拉出体外;第四步,在放射线 10. The claim requires a surgical dissection of any of claims 1-7 by use of the stent graft, characterized by comprising the steps of: 51: before surgery, stent graft delivery device within compressed ; 52: start operation, the first step: free operation respectively left and right brachial artery, the left external carotid artery and the femoral artery standby; Step: in DSA guidance, the guide wire 4 from the side of the lower limbs penetrate the femoral artery, through which a super-hard wire to the ascending aorta, I 3, respectively 0.018cm * 2.6m guidewire upper left brachial artery, brachial artery right arm, left external carotid artery piercing; step : 4, respectively, into the corresponding guide wire tail pipe 4, the intermediate tube delivery sheath penetrated superhard guidewire, the distal end of the guidewire right brachial artery is penetrated brachiocephalic artery stent balloon catheters, left the outside of the carotid artery is penetrated by the distal end of the guidewire left common carotid artery catheter balloon expandable stent, the distal end of the guidewire left brachial artery is penetrated by a balloon expandable stent left subclavian catheter, the catheter along the guide wire forward respectively from the left and right brachial artery and external carotid artery on the left side drawn in vitro; a fourth step, the radiation 观察,覆膜支架输送系统送达主动脉弓预定位置时,同时牵拉三根导管,使其同步到达主动脉弓的位置;第五步:输送覆膜支架到达主动脉弓位置后,由近端到远端逐步解除支架束缚;第六步:调整覆膜支架位置,将三个球囊扩张支架对准并进入主动脉弓的头臂干动脉、左颈总动脉、左锁骨下动脉三个分支开口,牵拉左右上肢的导管及左侧颈外动脉导管,使之进入相应的动脉;第七步:扩张左颈总动脉内球扩支架,同步牵拉左右上肢对应的头臂干动脉、左锁骨下动脉导管,覆膜支架主体在主动脉弓内固定;第八步:扩张头臂干动脉支架;第九步:再扩张左锁骨下动脉支架;最后,逐渐释放直径较细的远端,覆膜支架支撑体自行弹开全部释放; S3:撤出输送鞘,再次升主动脉造影,缝合手术切口,完成手术。 Observation, stent graft delivery system delivery aortic arch predetermined position, while pulling three conduits, it reaches the position of the synchronization of the aortic arch; Step 5: delivery stent-graft reaches the position of the aortic arch, from the proximal to distal gradual lifting bracket bound; sixth step: adjusting the position of the stent-graft, balloon-expandable stent aligning the three aortic arch and into the brachiocephalic artery, the left common carotid artery three branches of the left subclavian opening, pulling the left and right upper conduit and an outer left carotid artery catheter into the respective arteries so; seventh step: the total expansion of the left common carotid artery ball expanding stent, pulling the left and right upper limb corresponding to the synchronization brachiocephalic artery, the left subclavian artery catheters, stent-graft body secured within the aortic arch; eighth step: brachiocephalic artery stent expansion; step 9: re-expansion of the stent left subclavian artery; Finally, the gradual release of smaller diameter of the distal stent graft self-supporting body to release all bounce ; S3: withdrawal of the delivery sheath, ascending aorta, suture the incision once again to complete the operation.
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