WO2014180161A1 - 一种分支和开窗型胸主动脉腔内隔绝移植物 - Google Patents

一种分支和开窗型胸主动脉腔内隔绝移植物 Download PDF

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Publication number
WO2014180161A1
WO2014180161A1 PCT/CN2014/000397 CN2014000397W WO2014180161A1 WO 2014180161 A1 WO2014180161 A1 WO 2014180161A1 CN 2014000397 W CN2014000397 W CN 2014000397W WO 2014180161 A1 WO2014180161 A1 WO 2014180161A1
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Prior art keywords
branch
blood vessel
artificial blood
membrane
vessel membrane
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PCT/CN2014/000397
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English (en)
French (fr)
Inventor
陆清声
景在平
张勇学
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中国人民解放军第二军医大学
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Publication of WO2014180161A1 publication Critical patent/WO2014180161A1/zh

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Definitions

  • the present invention relates to the field of medical device technology, and more particularly to a branch and a sacral aortic insulative graft for treating aortic dilatation diseases. Background technique
  • Aortic dissection refers to the blood in the aortic lumen from the aortic intima tear into the aortic media, separating the media and expanding along the long axis of the aorta, thus forming a true and false aorta a pathological change.
  • the main hazard is that the direct rupture of the false lumen or the formation of an aneurysm rupture causes massive hemorrhage, and the blood supply of the important branches of the aorta is interrupted during the formation of the dissection, resulting in the loss of severe ischemic function of important organs, causing serious complications. Or death.
  • Aortic aneurysm refers to a local or diffuse dilatation of the aortic wall.
  • the main hazards are as follows: 1. The tumor is ruptured, the aneurysm wall is gradually inflated and thinned by the blood flow, and finally the tumor is ruptured and causes fatal bleeding; 2. Coronary thrombosis, tumor enlargement The blood flow is slow, forming eddy currents. If the inner surface of the tumor wall is rough, it is easy to form a thrombus. The thrombus can cause embolism. 3. The normal tissue and organs around the tumor can cause discomfort or other diseases, such as pressing the esophagus to cause difficulty in swallowing, compressing the trachea. Causes breathing difficulties, oppresses the recurrent laryngeal nerve and causes hoarseness. In recent years, with the increase in the incidence of hypertension atherosclerosis, the incidence of aortic dilatation disease has increased significantly, and there is a tendency to become younger.
  • a straight tube type endoluminal graft is inserted into the vascular lumen to close the dissection or to isolate the aortic aneurysm for therapeutic purposes.
  • the intravascular graft graft comprises a tubular wire stent and an artificial blood vessel sutured or bonded to the inner side of the stent.
  • the tubular wire stent is formed by folding the elastic metal wire into a straight tube shape after z-folding.
  • the artificial blood vessel is made of artificial blood vessel membrane material, and the artificial blood vessel membrane material is usually polyester (polyethylene terephthalate, polyethylene terephthalate referred to as PET).
  • the intravascular isolated graft is compressed and loaded into the conveyor, and sent to the aortic lesion through the distal femoral artery or radial artery to be released by the conveyor, and automatically restored to straight due to the elastic force of the wire stent.
  • the tubular shape is tightly attached to the inner wall of the aorta to isolate the lesion from normal blood flow for therapeutic purposes. This method does not require open surgery, simple and minimally invasive, effective, and successfully treated a large number of patients, so it has been widely promoted.
  • the intraluminal graft is limited by its structure and can only be used to treat aortic dilatation diseases that do not involve important branches, that is, originating from the descending thoracic aorta, and the distance from the proximal cleft to the left subclavian artery.
  • the present invention provides a branching and fenestration type suitable for treating aortic arch or ascending aortic aortic dissection or aortic aneurysm to ensure blood supply to important branch arteries when the lesion is located in the ascending aorta or aortic arch.
  • the graft was isolated from the thoracic aorta.
  • the present invention relates to a branch and fenestration type thoracic aortic endovascular graft, comprising: an artificial blood vessel membrane, and an elastic wire support is covered on an outer wall or an inner wall of the artificial blood vessel membrane,
  • the artificial blood vessel membrane is arched;
  • the mounting hole is disposed on one side of the arched protrusion of the artificial blood vessel membrane;
  • the branch is fixed to the artificial blood vessel membrane through the mounting hole;
  • An anchoring point disposed on the artificial blood vessel membrane.
  • the number of the positioning points is two or more.
  • the number of the mounting holes is one to three.
  • the number of the branches is 1 to 3.
  • the artificial blood vessel membrane has an arched height of 40 mm to 80 mm, the artificial blood vessel membrane has an outer diameter of 30 mm to 45 mm, and the artificial blood vessel membrane has a length of 90 mm to 200 mm.
  • the branch has an outer diameter of 10 mm to 20 mm, and the branch has a length of 20 mm to 30 mm.
  • the angle between the extension line of the branch axis and the line connecting the ends of the artificial blood vessel film axis is 60 degrees to 120 degrees.
  • the mounting hole has a diameter of 10 mm to 20 mm.
  • the spacing between the mounting holes is 10 mm.
  • the artificial blood vessel membrane is made of a polyester fabric.
  • the elastic wire support is folded in a "Z" shape.
  • the elastic wire bracket is made of stainless steel.
  • the positioning point is "8" shape.
  • the branches are straight tubular.
  • the invention discloses a branching and fenestration type thoracic aortic endovascular graft graft which is closed and is located in the ascending main Arterial or aortic arch dissection, and can ensure the blood supply of the brachial artery, the left common carotid artery, the left subclavian artery and other branch arteries.
  • an arched tubular structure conforming to the curvature of the human aortic arch is used, so that the graft in the cavity is more reasonable and tightly attached to the aortic arch.
  • FIG. 1 is a schematic view showing the structure of a branching and fenestration type thoracic aortic endovascular graft according to the present invention
  • FIG. 2 is a schematic view showing the structure of a second embodiment of a branch and fenestration type thoracic aortic endovascular graft according to the present invention
  • Fig. 3 is a schematic view showing the structure of a third embodiment of a branch and fenestration type thoracic aortic lumen graft according to the present invention.
  • Embodiment 1 As shown in FIG. 1 , a vascular body of a branch and a mounting type thoracic aortic lumen graft is made of a thin polyester fabric vascular membrane 1 and sutured or bonded to artificial blood.
  • the elastic wire support 2 of the outer wall of the tubular membrane 1 is composed of three parts of a branch 4, a mounting hole 3 and an anchoring point 5 on the blood vessel main body.
  • the main body of the blood vessel is an arched tubular structure conforming to the curvature of the aortic arch of the human body. On the convex side of the arch is provided with a straight tubular branch 4 which is connected and integrated with the body, and two "8" are connected between the branch 4 and the main body of the blood vessel.
  • the glyph positioning point 5 is used for the positioning of the branch 4, which can be extended into the corresponding branch artery on the aortic arch after release; the mounting body 3 is provided with two mounting holes 3 at the position of the other branch artery opening, around the mounting hole 3. Two "8" shaped positioning points 5 are provided for the positioning of the mounting hole 3, and after the release, the branch artery opening can be aligned to ensure blood flow.
  • the vascular body has an outer diameter of 35 mm, a total length of 120 mm, a length of 20 mm with a branch 4, an arch height of 40 mm, and a width of 90 mm.
  • the tubular branch 4 has an outer diameter of 10 mm and a length of 20 mm and is at an angle of 70 degrees to the main body of the blood vessel.
  • the two mounting holes 3 have a diameter of 10 mm, the distance between the two mounting holes 3 is 10 mm, and the distance from the branch 4 is 10 mm.
  • the branch 4 is aligned with the brachiocephalic trunk, and the two mounting holes 3 are respectively aligned with the left common carotid artery and the left subclavian artery.
  • a blood vessel main body of a branched and mounted thoracic aortic lumen graft is made of a thin polyester fabric artificial blood vessel membrane 1 and is sutured or bonded to the outer wall of the artificial blood vessel membrane 1.
  • the elastic wire holder 2 is composed of three parts: a branch 4, a mounting hole 3 and an anchoring point 5 on the main body of the blood vessel.
  • the main body of the blood vessel is an arched tubular structure conforming to the curvature of the aortic arch of the human body. On the convex side of the arch is provided with a straight tubular branch 4 which is connected and integrated with the body, and two "8" are connected between the branch 4 and the main body of the blood vessel.
  • the glyph positioning point 5 is used for the positioning of the branch 4, which can be extended into the corresponding branch artery on the aortic arch after release; the mounting body 3 is provided with two mounting holes 3 at the position of the other branch artery opening, around the mounting hole 3. Two "8" shaped positioning points 5 are provided for the positioning of the mounting hole 3, and after the release, the branch artery opening can be aligned to ensure blood flow.
  • the vascular body has an outer diameter of 35 mm, a total length of 120 mm, a length of 100 mm with a branch 4, an arch height of 40 mm, and a width of 90 mm.
  • the tubular branch 4 has an outer diameter of 10 mm and is long. The degree is 20 mm and the angle with the main body of the blood vessel is 100 degrees.
  • the two mounting holes 3 have a diameter of 10 mm, the distance between the two mounting holes 3 is 10 mm, and the distance from the branch 4 is 10 mm. In use, the branch 4 is aligned with the left subclavian artery, and the two mounting holes 3 are respectively aligned with the left common carotid artery and the brachiocephalic trunk.
  • the vascular body of the branching and mounting hole type thoracic aortic lumen graft is composed of a thin polyester fabric artificial blood vessel membrane 1 and is sutured or bonded to the outer wall of the artificial blood vessel membrane 1.
  • the elastic wire holder 2 is composed of three parts: a branch 4, a mounting hole 3 and an anchoring point 5 on the main body of the blood vessel.
  • the main body of the blood vessel is an arched tubular structure conforming to the curvature of the aortic arch of the human body. On the convex side of the arch is provided with a straight tubular branch 4 which is connected and integrated with the body, and two "8" are connected between the branch 4 and the main body of the blood vessel.
  • the glyph positioning point 5 is used for the positioning of the branch 4, which can be extended into the corresponding branch artery on the aortic arch after release; the mounting body 3 is provided with two mounting holes 3 at the position of the other branch artery opening, around the mounting hole 3. Two "8" shaped positioning points 5 are provided for the positioning of the mounting hole 3, and after the release, the branch artery opening can be aligned to ensure blood flow.
  • the vascular body has an outer diameter of 35 mm, a total length of 120 mm, a length of 60 mm with a branch 4, an arch height of 40 mm, and a width of 90 mm.
  • the tubular branch 4 has an outer diameter of 10 mm and a length of 20 mm and an angle of 85 degrees to the main body of the blood vessel.
  • the two mounting holes 3 have a diameter of 10 mm, the distance between the two mounting holes 3 is 20 mm, and the distance from the branch 4 is 10 mm.
  • the branch 4 is aligned with the left common carotid artery, and the two mounting holes 3 are aligned with the brachiocephalic trunk and the left subclavian artery, respectively.
  • each branch and the aortic lumen graft are firstly compressed into a clinically used delivery system, each branch is connected to a corresponding guide wire, and the delivery system will be introduced from the lower extremity artery to the ascending aorta or aortic arch lesion.
  • the part is partially released, and the guide wire connected to the branch is guided into the corresponding branch artery under the traction of the reserved guide wire placed in the branch artery, and the connected branch is also introduced into the corresponding branch artery, and the branch can be used alone or 2 Or 3 settings in the installation In the hole, use in combination.
  • the branches accurately locate the positions of the branches and the mounting holes according to the positioning points of the branches and the mounting holes, and finally release completely.
  • the branching aortic lumen graft graft automatically returns to its original shape under the elastic force of the wire stent and is in close contact with the aortic arch and the inner wall of the branch artery.
  • the invention discloses a branch and fenestration type thoracic aortic endovascular graft graft which is closed in the ascending aorta or aortic arch dissection, and can protect the blood of the branch artery of the brachial artery, the left common carotid artery and the left subclavian artery. for.
  • an arched tubular structure conforming to the curvature of the human aortic arch is used, so that the graft in the lumen is attached to the aortic arch more rationally and closely.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)

Abstract

一种分支和开窗型胸主动脉腔内隔绝移植物，包括：人造血管膜（1），在所述人造血管膜（1）的外壁上或内壁上覆盖有弹性金属丝支架（2）,所述人造血管膜（1）为拱形；安装孔（3），所述安装孔（3）设置在所述人造血管膜（1）拱形凸起的一侧；分支（4），所述分支（4）通过所述安装孔（3）固定在所述人造血管膜（1）上；以及定位点（5），所述定位点（5）设置在所述人造血管膜（1）上。该分支和开窗型胸主动脉腔内隔绝移植物达到封闭位于升主动脉或主动脉弓夹层裂口，并可保障头臂干动脉、左颈总动脉、左锁骨下动脉等分支动脉的供血。采用符合人体主动脉弓弯曲度的拱形管状结构，使腔内隔绝移植物与主动脉弓部贴附更为合理与紧密。

Description

说 明 书 技术领域
本发明涉及医疗器械技术领域， 特别是一种治疗主动脉扩张性疾病的 分支和幵窗型主动脉腔内隔绝移植物。 背景技术
主动脉夹层（aortic dissection)是指主动脉腔内血液从主动脉内膜 撕裂处进入主动脉中膜， 使中膜分离， 并沿主动脉长轴方向扩展， 从而形 成主动脉真假两腔的一种病理改变。 其主要危害是， 假腔的直接破裂或形 成动脉瘤后破裂造成大出血死亡， 夹层形成过程中中断了主动脉重要分支 的血供， 造成重要脏器的严重缺血功能丧失， 引起严重的并发症或死亡。 主动脉瘤（aortic aneurysm)是指主动脉壁局部或弥漫性扩张。 主要的危 害有以下几个方面： 1.瘤体破裂， 动脉瘤瘤壁受血流不断冲击而逐渐膨 大变薄， 最后瘤体破裂而引起致死性大出血； 2.附壁血栓形成， 瘤体膨 大处血流缓慢， 形成涡流， 如瘤壁内面粗糙， 则易形成血栓， 血栓脱落 可致栓塞； 3.瘤体压迫周围正常组织器官会引起不适或其它疾患， 如压 迫食道引起吞咽困难，压迫气管引起呼吸困难， 压迫喉返神经引起声音 嘶哑等。近年来随着高血压动脉粥样硬化发病率升高， 主动脉扩张性疾 病发病率显著上升， 并且有年轻化趋势。
目前已开展了主动脉扩张性疾病腔内隔绝术， 即采用微创方法， 通过 在血管腔内置入直管型的腔内移植物来封闭夹层破口或隔绝主动脉瘤， 从 而达到治疗目的。 所说的血管腔内隔绝移植物由管形金属丝支架和缝合或 粘合于支架内侧的人造血管组成， 管形金属丝支架由弹性金属丝经 z形折 叠后围成直管形而成， 人造血管由人造血管膜材料制成， 人造血管膜材料 通常为涤纶 （聚对苯二甲酸乙二醇酯， polyethylene terephthalate简 称 PET)。 使用时将血管腔内隔绝移植物压缩后装载于输送器中， 由输送器 通过远处股动脉或髂动脉送到主动脉病变处再将其释放， 由于金属丝支架 的弹力作用自动恢复成直管状并紧贴于主动脉内壁， 将病变与正常血流隔 离， 从而达到了治疗目的。 这一方法无需开放性手术， 简捷微创、 疗效确 切， 成功救治了大批病员， 因此得到了广泛的推广。
但是， 直管型腔内移植物受限于其结构， 只能用于治疗未累及重要分 支的主动脉扩张性疾病， 即起源于胸降主动脉， 且近端破口距左锁骨下动 脉距离大于 15mm的 B型主动脉夹层或位于胸降主动脉的主动脉瘤。而对于 累及主动脉弓或升主动脉的 A型主动脉夹层或主动脉瘤， 由于存在供应头 颈及上肢的重要分支动脉， 如头臂干、 左颈总动脉、 左锁骨下动脉， 使用 直管型的腔内隔绝移植物隔绝病变的同时会一同封闭重要的分支动脉， 导 致脑梗等严重的并发症。因此临床上迫切需要研发新型的腔内移植物系统， 使之可用于主动脉弓部及升主动脉扩张性疾病的腔内治疗。 发明内容
本发明提供了一种适于治疗累及主动脉弓或升主动脉主动脉夹层或主 动脉瘤的在封闭位于升主动脉或主动脉弓的病变时能保障其重要分支动脉 血供的一种分支和开窗型胸主动脉腔内隔绝移植物。 为解决上述技术问题， 本发明一种分支和开窗型胸主动脉腔内隔绝移 植物， 包括： 人造血管膜， 在所述人造血管膜的外壁上或内壁上覆盖有弹 性金属丝支架， 所述人造血管膜为拱形； 安装孔， 所述安装孔设置在所述 人造血管膜拱形凸起的一侧； 分支， 所述分支通过所述安装孔固定在所述 人造血管膜上； 以及定位点， 所述定位点设置在所述人造血管膜上。
优选的， 所述定位点的数量为 2个以上。
优选的， 所述安装孔的数量为 1个〜 3个。
优选的， 所述分支的数量为 1个〜 3个。
优选的，所述人造血管膜的拱形高度为 40毫米〜 80毫米，所述人造血 管膜的外直径为 30毫米〜 45毫米， 所述人造血管膜的长度为 90毫米〜 20 0毫米。
优选的， 所述分支的外直径为 10毫米〜 20毫米， 所述分支的长度为 2 0毫米〜 30毫米。
优选的， 所述分支轴线的延长线与所述人造血管膜轴线两端的连线的 夹角为 60度〜 120度。
优选的， 所述安装孔是直径为 10毫米〜 20毫米。
优选的， 所述安装孔之间的间距为 10毫米。
优选的， 所述人造血管膜的材质为涤纶织物。
优选的， 所述弹性金属丝支架按 "Z"形折叠围成。
优选的， 所述弹性金属丝支架的材质为不锈钢。
优选的， 所述定位点为 "8 "形。
优选的， 所述分支为直形管状。
本发明一种分支和开窗型胸主动脉腔内隔绝移植物达到封闭位于升主 动脉或主动脉弓夹层裂口， 并可保障头臂干动脉、 左颈总动脉、 左锁骨下 动脉等分支动脉的血供。 同时采用符合人体主动脉弓弯曲度的拱形管状结 构， 使腔内隔绝移植物与主动脉弓部贴附更为合理与紧密。 附图说明
图 1为本发明一种分支和开窗型胸主动脉腔内隔绝移植物实施例一结 构示意图；
图 2为本发明一种分支和开窗型胸主动脉腔内隔绝移植物实施例二结 构示意图；
图 3为本发明一种分支和开窗型胸主动脉腔内隔绝移植物实施例三结 构示意图。
本发明一种分支和开窗型胸主动脉腔内隔绝移植物附图中附图标记说 明-
1-人造血管膜 2-弹性金属丝支架 3-安装孔
4-分支 5-定位点 具体实施方式
下面结合附图对本发明一种分支和开窗型胸主动脉腔内隔绝移植物作 进一步详细说明。
下面结合附图对本发明一种分支和安装孔型胸主动脉腔内隔绝移植物 作进一步详细说明。
实施例一， 如图 1所示， 本发明一种分支和安装孔型胸主动脉腔内隔 绝移植物的血管主体由薄型涤纶织物人造血管膜 1和缝合或粘合于人造血 管膜 1外壁的弹性金属丝支架 2组成， 在血管主体上设有分支 4、 安装孔 3 及定位点 5三个部分。血管主体为符合人体主动脉弓弯曲的拱形管状结构, 在拱形的凸起侧设有 1个与其相通并连为一体的直形管状分支 4，在分支 4 与血管主体相连处设 2个 "8 "字形定位点 5用于分支 4的定位， 其在释放 后可伸入主动脉弓上的相应分支动脉内； 血管主体上在其他分支动脉开口 的位置设有 2个安装孔 3， 在安装孔 3周围设 2个 "8 "字形定位点 5用于 安装孔 3的定位， 在释放后可对准分支动脉开口而保证其血流。
血管主体的管外径 35毫米， 总长度为 120毫米， 以分支 4为界段长 2 0毫米， 拱形高度为 40毫米， 宽 90毫米。 管形分支 4外径为 10毫米， 长 度为 20毫米，与血管主体的夹角为 70度。 2个安装孔 3的直径为 10毫米， 2个安装孔 3之间的距离为 10毫米，与分支 4之间的距离为 10毫米。使用 时，分支 4对准头臂干， 2个安装孔 3分别对准左颈总动脉及左锁骨下动脉。
实施例二， 如图 2所示， 本发明一种分支和安装孔型胸主动脉腔内隔 绝移植物的血管主体由薄型涤纶织物人造血管膜 1和缝合或粘合于人造血 管膜 1外壁的弹性金属丝支架 2组成， 在血管主体上设有分支 4、 安装孔 3 及定位点 5三个部分。血管主体为符合人体主动脉弓弯曲的拱形管状结构， 在拱形的凸起侧设有 1个与其相通并连为一体的直形管状分支 4，在分支 4 与血管主体相连处设 2个 "8 "字形定位点 5用于分支 4的定位， 其在释放 后可伸入主动脉弓上的相应分支动脉内； 血管主体上在其他分支动脉开口 的位置设有 2个安装孔 3 , 在安装孔 3周围设 2个 " 8"字形定位点 5用于 安装孔 3的定位， 在释放后可对准分支动脉开口而保证其血流。
血管主体的管外径 35毫米， 总长度为 120毫米， 以分支 4为界段长 1 00毫米， 拱形高度为 40毫米， 宽 90毫米。管形分支 4外径为 10毫米， 长 度为 20毫米，与血管主体的夹角为 100度。 2个安装孔 3的直径为 10毫米， 2个安装孔 3之间的距离为 10毫米，与分支 4之间的距离为 10毫米。使用 时，分支 4对准左锁骨下动脉， 2个安装孔 3分别对准左颈总动脉及头臂干。
实施例三， 如图 3所示， 本发明一种分支和安装孔型胸主动脉腔内隔 绝移植物的血管主体由薄型涤纶织物人造血管膜 1和缝合或粘合于人造血 管膜 1外壁的弹性金属丝支架 2组成， 在血管主体上设有分支 4、 安装孔 3 及定位点 5三个部分。血管主体为符合人体主动脉弓弯曲的拱形管状结构， 在拱形的凸起侧设有 1个与其相通并连为一体的直形管状分支 4，在分支 4 与血管主体相连处设 2个 "8"字形定位点 5用于分支 4的定位， 其在释放 后可伸入主动脉弓上的相应分支动脉内； 血管主体上在其他分支动脉开口 的位置设有 2个安装孔 3， 在安装孔 3周围设 2个 "8 "字形定位点 5用于 安装孔 3的定位， 在释放后可对准分支动脉开口而保证其血流。
血管主体的管外径 35毫米， 总长度为 120毫米， 以分支 4为界段长 6 0毫米， 拱形高度为 40毫米， 宽 90毫米。 管形分支 4外径为 10毫米， 长 度为 20毫米，与血管主体的夹角为 85度。 2个安装孔 3的直径为 10毫米， 2个安装孔 3之间的距离为 20毫米，与分支 4之间的距离为 10毫米。使用 时，分支 4对准左颈总动脉， 2个安装孔 3分别对准头臂干及左锁骨下动脉。
使用时， 根据病变主动脉夹层的部位和相应的动脉内径， 选择合适规 格型号。 先将分支和安装孔型主动脉腔内隔绝移植物压缩后装入临床上常 用的输送系统中， 各分支分别与相应导丝相连， 由输送系统将从下肢动脉 导入至升主动脉或主动脉弓病变部位并部分释放， 与分支相连的导丝在预 先放置于分支动脉内的预留导丝的牵引下导入相应分支动脉， 并使相连分 支亦导入相应的分支动脉， 分支可单独使用， 也可 2个或 3个设置在安装 孔内， 进行组合使用。 同时分支根据分支及安装孔的定位点准确定位各个 分支及安装孔的位置， 最后完全释放。 分支型主动脉腔内隔绝移植物在金 属丝支架的弹力作用下自动恢复成原状并紧贴于主动脉弓及分支动脉内 壁。
本发明一种分支和开窗型胸主动脉腔内隔绝移植物达到封闭位于升主 动脉或主动脉弓夹层裂口， 并可保障头臂干动脉、 左颈总动脉、 左锁骨下 动脉等分支动脉的血供。 同时采用符合人体主动脉弓弯曲度的拱形管状结 构， 使腔内隔绝移植物与主动脉弓部贴附更为合理与紧密。
以上已对本发明创造的较佳实施例进行了具体说明， 但本发明创造并 不限于所述实施例， 熟悉本领域的技术人员在不违背本发明创造精神的前 提下还可作出种种的等同的变型或替换， 这些等同的变型或替换均包含在 本申请权利要求所限定的范围内。

Claims

权 利 要 求 书
1.一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于， 包括： 人造血管膜， 在所述人造血管膜的外壁上或内壁上覆盖有弹性金属丝 支架， 所述人造血管膜为拱形；
安装孔， 所述安装孔设置在所述人造血管膜拱形凸起的一侧； 分支， 所述分支通过所述安装孔固定在所述人造血管膜上； 以及 定位点， 所述定位点设置在所述人造血管膜上。
2.根据权利要求 1所述的一种分支和幵窗型胸主动脉腔内隔绝移植物， 其特征在于， 所述定位点的数量为 2个以上， 所述定位点为 "8 "形。
3.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于， 所述安装孔的数量为 1个〜 3个， 所述安装孔是直径为 10毫 米〜 20毫米， 所述安装孔之间的间距为 10毫米。
4.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于，所述分支的数量为 1个〜 3个，所述分支的外直径为 10毫米〜 20毫米， 所述分支的长度为 20毫米〜 30毫米， 所述分支为直形管状。
5.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于，所述人造血管膜的拱形高度为 40毫米〜 80毫米，所述人造血 管膜的外直径为 30毫米〜 45毫米， 所述人造血管膜的长度为 90毫米〜 20 0毫米。
6.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于， 所述分支轴线的延长线与所述人造血管膜轴线两端的连线的 夹角为 60度〜 120度。
7.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于， 所述人造血管膜的材质为涤纶织物。
8.根据权利要求 1所述的一种分支和开窗型胸主动脉腔内隔绝移植物， 其特征在于， 所述弹性金属丝支架按 "Z"形折叠围成。
9.根据权利要求 1或 8所述的一种分支和开窗型胸主动脉腔内隔绝移 植物， 其特征在于， 所述弹性金属丝支架的材质为不锈钢。
PCT/CN2014/000397 2013-05-08 2014-04-14 一种分支和开窗型胸主动脉腔内隔绝移植物 WO2014180161A1 (zh)

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