WO2012071754A1 - 带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置 - Google Patents

带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置 Download PDF

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Publication number
WO2012071754A1
WO2012071754A1 PCT/CN2010/079798 CN2010079798W WO2012071754A1 WO 2012071754 A1 WO2012071754 A1 WO 2012071754A1 CN 2010079798 W CN2010079798 W CN 2010079798W WO 2012071754 A1 WO2012071754 A1 WO 2012071754A1
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Prior art keywords
ring
rod
valve
aortic valve
delivery
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PCT/CN2010/079798
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English (en)
French (fr)
Inventor
孔祥清
蔡菁
Original Assignee
Kong Xiangqing
Cai Jing
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Application filed by Kong Xiangqing, Cai Jing filed Critical Kong Xiangqing
Priority to US13/990,275 priority Critical patent/US20140052239A1/en
Publication of WO2012071754A1 publication Critical patent/WO2012071754A1/zh

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Classifications

    • 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
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • 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
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439Expansion controlled by filaments

Definitions

  • Transplant device for percutaneous aortic valve replacement with valve positioning function
  • the present invention relates to a medical device, and more particularly to a delivery device for use in percutaneous aortic valve replacement surgery for accurately positioning a stent, in particular a percutaneous aortic valve replacement with valve positioning function Use a conveyor.
  • aortic stenosis caused by aortic valve calcification is 2% to 7% in elderly people over 65 years old, and the proportion increases with age.
  • the left ventricular function is severely impaired, the patient's quality of life is degraded and the survival time is significantly shortened, and effective treatment must be performed. So far, surgical aortic valve replacement is still the treatment of choice for patients with surgical indications.
  • the object of the present invention is to solve the problem that the valve position cannot be adjusted during the existing valve replacement process, and the valve installation is not in place or inaccurate, which causes surgery failure or postoperative complications.
  • the valve delivery device enters the human body together to prevent the release and dislocation of the valve stent, and the percutaneous aortic valve replacement surgical delivery device with valve positioning function that can adjust the position of the valve support.
  • a transcutaneous aortic valve replacement surgical delivery device with a valve positioning function characterized in that it comprises:
  • a delivery rod 1 the end of the delivery rod 1 extending into the human body is used to set the valve support 9;
  • a delivery sheath 5 which is placed on the delivery rod 1 and is used to receive the valve support 9;
  • a ring 3 which is placed on the lower end of the percutaneous aortic valve replacement surgical delivery rod 1 and is located at the delivery In the sheath 5;
  • the number of the positioning rods 2 is at least two, one end of the positioning rod 2 is hinged on the aforementioned conveying rod 1, and the hinge point is located at the upper portion of the aforementioned ring 3;
  • a ring control cable 4 the number of the ring control cables 4 is at least two, and the lower end of the ring control cable 4 is provided with a structure supporting the ring 3 or directly connected to the ring 3, the ring The upper end of the operating cable 4 projects axially out of the human body along the conveying rod 1.
  • the delivery rod 1, the sheath 5, the circular ring 3, the positioning rod 2 and the circular control cable 4 constitute the delivery device for percutaneous aortic valve replacement surgery with the valve positioning function of the present invention.
  • the cantilever end of the positioning rod 2 has a circular arc or a ring structure, and the positioning rod 2 can be deployed in a range of at least 90 degrees, and the length of the rod body should be larger than the radius of the left ventricle side of the implanted valve stent.
  • the supporting structure of the supporting ring 3 at the lower end of the ring operating cable 4 is a supporting cross bar 6 perpendicular to the main body of the ring operating cable 4, and the supporting cross bar 6 has an L-shaped structure together with the ring operating cable 4.
  • the surface of the conveying rod 1 is provided with an axial groove 7 for placing the ring operating cable 4 in the same number as the ring operating cable 4.
  • the end of the ring control cable 4 extending out of the human body is connected to a conventional synchronous or single operating mechanism.
  • the invention can play a good auxiliary role in positioning the implanted valve, can improve the success rate of percutaneous aortic valve replacement, reduce the difficulty of surgery, reduce the pain and risk of surgery for the patient, and reduce the doctor. Treatment costs.
  • the invention does not require an increase in the inner diameter of the delivery sheath. All positioning devices can be gathered into a thin tubular shape without the need to increase the inner diameter of the delivery sheath.
  • the positioning device of the present invention can finely adjust the position and angle of the valve after the valve is released to optimize the implantation position.
  • the hook-like structure at the end of the positioning rod of the present invention can prevent some specific tissues (such as bundle branches, mitral chordae, etc.) from being compressed to reduce postoperative complications and improve the quality of life of postoperative patients.
  • the invention has the advantages of simple structure, convenient manufacture and easy realization, and can be put into use only by appropriately improving the existing conveying rod.
  • FIG. 1 is a schematic view showing the structure of a positioning device of the present invention.
  • Fig. 2 is a schematic view showing the state of use of the positioning device of the present invention in a human body.
  • Figure 3 is a schematic cross-sectional view of the delivery rod of the present invention.
  • Fig. 2 9 is the implanted valve, 10 is the coronary sinus of the human heart, and 11 is the left ventricular outflow tract of the human heart.
  • a percutaneous aortic valve replacement surgical delivery device with a valve positioning function which is mainly composed of a delivery rod 1, a sheath 5, a positioning rod 2, a ring 3 and a ring manipulation cable 4, as shown in FIG.
  • the positioning rod 2 is connected to the distal end portion of the conveying rod 1 (on one end of the human body, that is, the lower end) through a fixed hinge.
  • the end of the positioning rod 2 is designed as a circular arc or a circular hook shape to prevent the tip from causing damage to the human body.
  • the rod body of the positioning rod 2 has a circular arc shape with a smooth edge, and the diameter of the hook portion after assembly is smaller than the inner diameter of the conveying sheath tube, and the positioning rod 2 should be unfolded within the range of at least 90 degrees under the driving of the ring 3, the rod body
  • the length should be greater than the radius of the left ventricular outflow tract side of the implanted valve 9, and its unfolded state is as shown in Fig. 2, at this time,
  • the diameter of the positioning rod 2 is larger than the outer diameter of the side of the outflow channel of the implanted valve. Therefore, after the valve is released, it will fall on the deployed positioning rod 2 without falling off.
  • the ring 3 When the ring 3 is assembled in the hook structure of the positioning rod 2 so that the pulling ring 3 is raised, the ring 3 can open the positioning rod 2 like an rib, and after opening, can slide on the conveying rod 1 to adjust the valve.
  • the position and angle of the bracket, the end of the ring control cable 4 may be L-shaped, and the main function of the crossbar 6 perpendicularly connected to the main body of the ring control cable 4 is to hook the ring 3 for adjustment operation, and at the same time It is convenient to separate from the ring 3, and the lower end L-shaped structure of the ring control cable 4 is used to form a support structure for supporting the ring 3, and the upper end of the ring control cable 4 is along the axial groove 7 on the conveying rod 1 (Fig. 3).
  • the through hole (located on the upper part of the segment 9 of the delivery rod 1 set of the valve support, that is, the step portion 10 in the figure) is worn out and extended to the outside to be connected with the operating mechanism, and the operating mechanism can adopt a conventional synchronous pulling structure, that is, several rings
  • the upper end of the control cable 4 is simultaneously fixed on a traction block, and then the traction block is moved by manual or electric pulling to drive the ring 3 to move.
  • each ring control cable 4 should be able to operate separately.
  • the lower end of the ring control cable 4 can also be directly connected or socketed to the ring 3.
  • the unused state of the positioning device of the present invention is shown in Fig. 1, which is wrapped in the sheath 5 as shown in Fig. 1.
  • the method of use of the invention is: first pulling the ring control cable 4 outside the outer body to slide the ring 3 upward, thereby driving the device positioning rod 2 to open, and releasing the 2/3 valve to pull up the whole conveyor, the end of the positioning rod 2 After the hook structure bears against the upper edge of the outflow tract, the remaining 1/3 of the valve is released, as shown in FIG.
  • the position and angle of the implanted valve can be fine-tuned by pulling the ring to manipulate the cable.
  • the test situation is as follows:
  • the entire interventional procedure was performed under fluoroscopy and guided by esophageal echocardiography.
  • the experimental animals were placed in a supine position on a catheterized operating bed. Ketamine anesthesia, connected to the ventilator after an endotracheal intubation, ECG Machine.

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  • Health & Medical Sciences (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

说明书
带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置 技术领域
本发明涉及一种医疗器械, 尤其是一种经皮主动脉瓣置换手术中使用的 用于使支架准确定位的输送装置, 具体地说是一种带瓣膜定位功能的经皮主 动脉瓣置换手术用输送装置。 背景技术
目前, 根据相关统计资料显示, 在年龄超过 65岁老年人中, 主动脉瓣钙 化所致的主动脉瓣狭窄发生率达 2%〜7%, 并随着年龄增长比例越来越高。严 重主动脉瓣狭窄病人左心功能严重受损, 病人生活质量下降且生存时间明显 缩短, 必须进行有效的治疗。 迄今为止, 对那些有手术适应症的患者而言, 外科人工主动脉瓣置换术仍然是首选治疗。
2002年, Alain Cribier在进行了大量动物试验的基础上, 首次为 1例 57岁的严重主动脉瓣狭窄病人进行了经导管人工主动脉瓣置换术。 自此, 经 导管主动脉瓣置换术以其创伤小, 术后并发症少等优点为临床上已失去外科 手术机会的患者带来了福音, 且在许多国家得到了发展和改进。 目前应用较 为广泛的是三叶自膨式主动脉瓣植入术, 且在生物材料和输送器械方面不断 改进, 使经皮主动脉瓣置换成为可能。
目前限制该项技术开展的一个主要问题是由于操作过程中对于植入器 械的定位不能很好控制, 导致释放脱落或位置不准确, 严重影响了手术的成 功率和术后并发症的控制。 发明内容
本发明的目的是针对现有的瓣膜置换过程中瓣膜位置无法调整, 易导致 瓣膜安装不到位或不准确引起手术失败或术后并发症的问题, 设计一种能与 瓣膜输送装置一起进入人体不仅能防止瓣膜支架释放脱位, 而且能对瓣膜支 架的位置进行调整的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置。
本发明的技术方案是:
一种带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置, 其特征是它 包括:
一输送杆 1, 该输送杆 1的伸入人体的一端用于套装瓣膜支架 9;
一输送鞘管 5, 该输送管 5套装在输送杆 1并用于收纳瓣膜支架 9; 一圆环 3, 该圆环 3套装在经皮主动脉瓣置换手术用输送杆 1的下端上 并位于输送鞘管 5中;
一定位杆 2, 定位杆 2的数量至少为两个, 定位杆 2的一端铰接在前述 的输送杆 1上, 且铰接点位于前述圆环 3的上部;
一圆环操纵索 4, 圆环操纵索 4的数量至少为两根, 所述圆环操纵索 4 的下端设有一个支承圆环 3的结构或直接与所述的圆环 3相连, 圆环操纵索 4的上端沿输送杆 1轴向伸出人体外。
上述输送杆 1、 鞘管 5、 圆环 3、 定位杆 2和圆环操纵索 4即组成本发明 的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置。
所述的定位杆 2的悬臂端带有圆弧或圆环结构, 定位杆 2可在至少 90 度范围内展开, 杆体长度应大于植入瓣膜支架左室流出道侧半径。
所述的圆环操纵索 4下端的支承圆环 3的支承结构为一垂直于圆环操纵 索 4主体的支承横杆 6, 支承横杆 6与圆环操纵索 4一起呈 L形结构。
所述的输送杆 1的表面设有与圆环操纵索 4数量相等的用于放置圆环操 纵索 4的轴向凹槽 7。
所述的圆环操纵索 4 伸出人体外的一端与常规同步或单根操作机构相 连。
本发明的有益效果:
1、本发明对于植入瓣膜的定位能起到很好的辅助作用,可提高经皮主动 脉瓣置换术的成功率, 降低手术难度, 为病人减少手术痛苦和风险, 降低医 疗费用。
2、本发明不需增加输送鞘管内径。所有定位装置可收拢成细管状, 不需 要增加输送鞘管内径。
3、 本发明的定位装置可在瓣膜释放后微调瓣膜的部位和角度使植入位 置更为优化。
4、本发明的定位杆末端的钩状结构可以避免一些特定组织(如束支, 二 尖瓣腱索等) 受压以减少术后并发症, 改善术后病人的生活质量。
5、 本发明结构简单, 制造方便, 易于实现, 仅需对现有的输送杆作适当 的改进即可投入使用。 附图说明
图 1是本发明的定位装置收拢装置时的结构示意图。
图 2是本发明的定位装置在人体内的使用状态示意图。
图 3是本发明的输送杆的横截面示意图。
图 2中 9为植入瓣膜, 10为人体心脏冠状窦, 11为人体心脏左室流出 道。 具体实施方式
下面结合附图和实施例对本发明作进一步的说明。
如图 1-3所示。
一种带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置, 它主要由输 送杆 1、 鞘管 5、 定位杆 2、 圆环 3及圆环操纵索 4组成, 如图 1所示, 定位 杆 2通过固定铰链连接在输送杆 1远端部分 (位于人体中的一端,即下端上), 定位杆 2的末端设计成圆弧或圆环形钩状, 以防止尖端对人体造成损伤, 定 位杆 2的杆体横截面为圆弧形,边缘光滑,装配后钩状部分的直径应小于输送 鞘管内径,定位杆 2应在圆环 3的带动下可在至少 90度范围内展开,杆体长 度应大于植入瓣膜 9左室流出道侧半径, 其展开状态如图 2所示, 此时, 由 于定位杆 2展开的直径大于植入瓣膜流出道侧的外径, 因此, 瓣膜释放后会 先落在展开的定位杆 2之上而不会脱落。 圆环 3装配时位于定位杆 2的钩状 结构中以使拉动圆环 3上升时, 圆环 3能使定位杆 2像伞骨一样撑开, 打开 后可在输送杆 1上滑动以便调整瓣膜支架的位置和角度, 圆环操纵索 4的末 端可为 L形, 与圆环操纵索 4主体垂直相连的横杆 6的主要作用是用于将圆 环 3钩住以便进行调整操作, 同时又便于与圆环 3分开, 圆环操纵索 4的下 端 L形结构用于形成支承圆环 3的支承结构, 圆环操纵索 4的上端沿输送杆 1上的轴向凹槽 7 (如图 3 )和通孔(位于输送杆 1套装瓣膜支架 9段的上部 即图中的台阶部分 10 )穿出后延至体外与操纵机构相连, 操纵机构可采用常 规的同步牵拉结构, 即将若干根圆环操纵索 4的上端同时固定在一个牵引块 上, 再通过手动或电动拉动牵引块移动从而带动圆环 3移动, 需要微调时, 每根圆环操纵索 4还应能单独操作。 此外, 具体实施时圆环操纵索 4的下端 也可直接与圆环 3固定或套接相连。
本发明的定位装置未使用的状态如图 1所示, 它被包覆在鞘管 5中, 如 图 1所示。 本发明的使用方法是: 先在体外拉动圆环操纵索 4使圆环 3向上 滑动,从而带动装置定位杆 2张开, 同时释放 2/3瓣膜后将输送器整体上拉, 定位杆 2末端钩状结构顶住流出道上缘后释放余 1/3瓣膜, 如图 2所示。 可 通过拉动圆环操纵索 4微调植入瓣膜的位置和角度。 放松圆环操纵索 4使圆 环 3下滑至定位杆 2的钩状结构中, 鞘管前进, 将定位杆 2和圆环 3收入鞘 管 5后撤出。 整个介入过程在经食管超声心动图的引导下进行, 结合造影及 心电图评价植入瓣膜的位置, 对冠状动脉血流和传导束的影响及有无瓣膜返 流情况。
下面结合具体的动物实验对本发明作进一步的说明。
试验情况如下:
5只绵羊, 体重 45— 50kg, 平均 46. 8kg。
整个介入过程在 X线透视下、 经食管超声心动图的引导下进行。 实验动 物仰卧位固定于导管手术床。 氯胺酮麻醉, 气管插管后连接呼吸机、 心电图 机。右颈动脉穿刺, 导入 18F动脉鞘, 左侧位 90度左心室造影, 了解左心室 流出道和主动脉的内径,选择比主动脉内径大 10 %— 20 %直径的经皮主动脉 瓣置换装置, 经输送系统送入经皮主动脉瓣置换装置, 在定位装置的辅助下 在主动脉瓣的位置释放植入主动脉瓣。采用心脏超声和主动脉根部造影结合, 观察植入器械的位置, 评价有无主动脉瓣的反流和冠状动脉的血流, 采用心 电图检测评价有无传导束受影响, 证实没有主动脉瓣的反流和冠状动脉血流 及心电图正常时手术结束。
实验结果: 5只动物, 除 1只因术中出血过多死亡以外,其余 4只成活。 于术后 2周、 4周、 8周分别处死 1只, 处死前行超声心动图检查, 主动脉瓣 血流正常, 没有主动脉瓣的反流, 处死后大体观察, 全部经皮主动脉瓣置换 装置位置良好, 未见移位, 肉眼观察经皮主动脉瓣置换装置表面及周围没有 血栓, 4周时经皮主动脉瓣置换装置表面约 80 %被内皮覆盖, 8周时经皮主 动脉瓣置换装置表面几乎完全被内皮覆盖。
本发明未涉及部分均与现有技术相同或可采用现有技术加以实现。

Claims

权利要求书
1、一种带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置, 其特征是它包 括:
一输送杆(1), 该输送杆(1)的伸入人体的一端用于套装瓣膜支架(9); 一输送鞘管 (5), 该输送管 (5) 套装在输送杆 (1) 并用于收纳瓣膜支 架 (9);
一圆环 (3), 该圆环 (3) 套装在经皮主动脉瓣置换手术用输送杆 (1) 的下端上并位于输送鞘管 (5) 中;
一定位杆 (2), 定位杆 (2) 的数量至少为两个, 定位杆 (2) 的一端铰 接在前述的输送杆 (1) 上, 且铰接点位于前述圆环 (3) 的上部;
一圆环操纵索 (4), 圆环操纵索 (4) 的数量至少为两根, 所述圆环操纵 索(4)的下端设有一个支承圆环(3)的结构或直接与所述的圆环(3)相连, 圆环操纵索 (4) 的上端沿输送杆 (1) 轴向伸出人体外。
2、根据权利要求 1所述的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装 置, 其特征是所述的定位杆 (2) 的悬臂端带有圆弧或圆环结构, 定位杆 (2) 可在至少 90 度范围内展开, 杆体长度应大于植入瓣膜支架左室流出道侧半 径。
3、根据权利要求 1所述的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装 置, 其特征是圆环操纵索 (4) 下端的支承圆环 (3) 的支承结构为一垂直于 圆环操纵索 (4) 主体的支承横杆 (6), 支承横杆 (6) 与圆环操纵索 (4)一 起呈 L形结构。
4、根据权利要求 1所述的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装 置, 其特征是所述的输送杆 (1) 的表面设有与圆环操纵索 (4) 数量相等的 用于放置圆环操纵索 (4) 的轴向凹槽 (7)。
5、根据权利要求 1所述的带瓣膜定位功能的经皮主动脉瓣置换手术用输送装 置, 其特征是所述的圆环操纵索(4)伸出人体外的一端与同步或单根操作机 构相连。
PCT/CN2010/079798 2010-11-30 2010-12-15 带瓣膜定位功能的经皮主动脉瓣置换手术用输送装置 WO2012071754A1 (zh)

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