CN100594045C - Delivery device for artificial heart stent valve - Google Patents
Delivery device for artificial heart stent valveDownload PDFInfo
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Translated fromChinese技术领域technical field
本发明涉及一种人体组织的替代品的输放装置，尤其涉及一种人工心脏支架瓣膜的输放装置。The invention relates to a delivery device for a human tissue substitute, in particular to a delivery device for an artificial heart stent valve.
背景技术Background technique
心脏是人体最重要的器官，心脏分为左右两部分，每一部分又包括心房和心室。左右心房和左右心室分别由房间隔和室间隔分开。在心脏内存在四个心脏瓣膜，即三尖瓣、肺动脉瓣、二尖瓣和主动脉瓣。在人体血液循环机构中，四个心脏瓣膜起着至关重要的作用。体循环机构的缺氧血液经腔静脉进入右心房，然后通过三尖瓣进入右心室，右心室收缩将血液通过肺动脉瓣压入肺循环机构，经过肺氧饱和后的血液经肺静脉回到左心房，再经二尖瓣到达左心室，左心室收缩将血液通过主动脉瓣排入主动脉而重返体循环机构。主动脉瓣膜下有左右冠状动脉开口。四个心脏瓣膜的结构保证了血液顺方向时瓣膜开放，逆方向时关闭，防止了血液返流而引起的心脏负担加重。但是，由于各种原因，可以导致心脏瓣膜的后天性损伤或病变，如风湿，动脉粥样硬化等。此外，先天性心脏病如法乐氏四联症，术后远期也可产生肺动脉瓣膜病变。瓣膜病变后表现为瓣膜功能逐渐丧失，如瓣膜关闭不全导致血液返流，瓣膜狭窄导致血液流通不畅，或关闭不全和狭窄二者兼并，以至加重心脏负担，导致心脏功能衰竭。对于心脏瓣膜的后天性损伤或病变，传统的治疗方法是开胸，心脏停跳后，在低温体外循环支持下，打开心脏进行病变瓣膜的外科修复或用人工心脏瓣膜置换。现有的人工心脏瓣膜分两大类：金属机械瓣膜和生物瓣膜。生物瓣膜由牛心包、牛颈静脉瓣、猪主动脉瓣等动物材料处理后制成。上述开心手术的方法，手术时间长，费用高，创伤大，风险大，金属机械瓣膜置换后病人需要长期抗凝治疗，生物瓣膜的材料寿命有限，通常需要再手术。The heart is the most important organ of the human body. The heart is divided into two parts, the left and the right, and each part includes the atrium and the ventricle. The left and right atria and right and left ventricles are separated by the atrial and ventricular septum, respectively. There are four heart valves in the heart, namely the tricuspid valve, pulmonary valve, mitral valve and aortic valve. In the human blood circulation mechanism, the four heart valves play a vital role. The hypoxic blood from the systemic circulation mechanism enters the right atrium through the vena cava, and then enters the right ventricle through the tricuspid valve. The contraction of the right ventricle pushes the blood into the pulmonary circulation mechanism through the pulmonary valve, and the oxygen-saturated blood returns to the left atrium through the pulmonary vein, and then Through the mitral valve to the left ventricle, the left ventricle contracts to expel blood through the aortic valve into the aorta and return to the systemic circulation. There are left and right coronary artery openings under the aortic valve. The structure of the four heart valves ensures that the valves open when the blood flows in the forward direction and close when the blood flows in the opposite direction, preventing the heart from increasing the burden caused by the backflow of blood. However, due to various reasons, acquired damage or disease of heart valves can be caused, such as rheumatism, atherosclerosis, etc. In addition, congenital heart disease such as tetralogy of Fallot can also cause pulmonary valve disease in the long term after surgery. After valvular disease, the valve function is gradually lost, such as valvular insufficiency leading to blood regurgitation, valvular stenosis leading to poor blood flow, or both insufficiency and stenosis, which will increase the burden on the heart and lead to heart failure. For the acquired damage or disease of the heart valve, the traditional treatment method is to open the chest, and after the heart stops beating, the heart is opened to perform surgical repair of the diseased valve or replace it with an artificial heart valve under the support of hypothermic extracorporeal circulation. The existing artificial heart valves are divided into two categories: metal mechanical valves and biological valves. Biological valves are made from processed animal materials such as bovine pericardium, bovine jugular valve, and porcine aortic valve. The above-mentioned open-heart surgery method has long operation time, high cost, large trauma, and high risk. After metal mechanical valve replacement, the patient needs long-term anticoagulant treatment, and the material life of the biological valve is limited, and reoperation is usually required.
为了解决上述开心手术治疗心脏瓣膜存在的问题，现在已有人尝试不作开心手术，而采用经皮介入方法输放人工心脏瓣膜。现有技术的介入式人工心脏瓣膜有二种：In order to solve the above-mentioned problems of open-heart surgery for the treatment of heart valves, some people try not to perform open-heart surgery, but use percutaneous intervention to deliver artificial heart valves. The interventional artificial heart valve of prior art has two kinds:
1、球囊扩张型1. Balloon-expandable
这种球囊扩张型人工心脏瓣膜为生物瓣膜，其介入方法是在一个可塑性变形的支架上分别固定生物瓣膜，通过径向压缩在一个球囊上后直径变小，经皮输放，然后给球囊加压使支架扩张固定，达到工作状态。This balloon-expandable artificial heart valve is a biological valve. The intervention method is to respectively fix the biological valve on a plastically deformable stent, radially compress it on a balloon, and then reduce the diameter, deliver it percutaneously, and then give it to the patient. The balloon is pressurized to expand and fix the stent to reach the working state.
1989年Henning Rud ANDERSEN(专利号WO9117720)率先进行了猪主动脉瓣经导管人工心脏瓣膜置换(文献…European Heart Journal 1992 13，704-708)。In 1989, Henning Rud ANDERSEN (Patent No. WO9117720) took the lead in carrying out porcine aortic valve transcatheter artificial heart valve replacement (document... European Heart Journal 1992 13, 704-708).
2000年Philippe BONHOEFFER(专利号EP1057460)和Alain CRIBIER(专利号EP0967939)分别首次进行了在人体的经导管介入的肺动脉瓣膜和主动脉瓣膜的人工心脏瓣膜置换。In 2000, Philippe BONHOEFFER (Patent No. EP1057460) and Alain CRIBIER (Patent No. EP0967939) carried out the artificial heart valve replacement of the pulmonary valve and aortic valve in the human body for the first time respectively.
球囊扩张型人工瓣膜存在的缺点和问题是：其直径由球囊直径所决定，如果人工瓣膜的直径一开始没选择好，或某些生理变化后，如自然生长、病理性血管扩张等，自然瓣膜的口径大小可能增大，而人工瓣膜的口径不能适应性增大，人工瓣膜有松动或滑脱的危险，只能进行二次球囊再扩张。The disadvantages and problems of the balloon-expandable artificial valve are: its diameter is determined by the diameter of the balloon. If the diameter of the artificial valve is not selected at the beginning, or after some physiological changes, such as natural growth, pathological vascular expansion, etc., The caliber of the natural valve may increase, but the caliber of the artificial valve cannot be adaptively increased, and the artificial valve may loosen or slip off, so only secondary balloon re-expansion can be performed.
2、自扩张型2. Self-expanding
这种人工瓣膜设有一个弹性变形支架，径向压缩后可自行扩张。This prosthetic valve features an elastically deformable stent that expands on its own after being radially compressed.
Marc BESSLER(专利号US5855601)和Jacques SEGUIN(专利号FR2826863，FR2828091)也设计了经导管人工心脏瓣膜置换。不同的是他们用了一个可弹性变形支架，径向压缩后可自行扩张。Marc BESSLER (Patent No. US5855601) and Jacques SEGUIN (Patent No. FR2826863, FR2828091) also designed transcatheter prosthetic heart valve replacement. The difference is that they used an elastically deformable stent that can expand by itself after radial compression.
Philippe BONHOEFFER(专利号EP1281375，US2003036791)的人工心脏瓣膜利用一个可弹性变形支架，在支架上游端或远端装有触头，压在内外两个鞘管内。The artificial heart valve of Philippe BONHOEFFER (patent No. EP1281375, US2003036791) utilizes an elastically deformable stent, and contacts are housed at the upstream end or the distal end of the stent, and are pressed in the two inner and outer sheath tubes.
本申请人曾在中国发明专利申请号200410054347.0中提到使用了中段为鼓型的支架瓣膜和自扩型加强化合成支架瓣膜，及捆绑式输放装置。The applicant once mentioned in the Chinese invention patent application number 200410054347.0 that he used a drum-shaped stent valve in the middle section, a self-expanding reinforced synthetic stent valve, and a bundled delivery device.
自扩张型人工瓣膜存在的缺点和问题是：自扩张型人工心脏瓣膜与鞘管间摩擦力大，影响人工瓣膜准确释放。The disadvantages and problems of the self-expandable artificial heart valve are: the frictional force between the self-expandable artificial heart valve and the sheath tube is large, which affects the accurate release of the artificial valve.
该捆绑式输放装置的支架拉线，穿过人工瓣膜的可变形单元时摩擦力大，不穿过时拉线易脱位。The bracket stay wire of the bundled delivery device has a large friction force when passing through the deformable unit of the artificial valve, and the stay wire is easy to dislocate when not passing through.
上述球囊扩张型和自扩张型人工心脏瓣膜存在的共同缺点和问题是：The common shortcoming and the problem that above-mentioned balloon expansion type and self-expanding artificial heart valve exist are:
1、现有的介入式人工支架瓣膜的输放装置和径向压缩下的支架瓣膜较硬，弯曲性差，经过主动脉弓不容易，不能对准自然主动脉瓣膜口。1. The delivery device of the existing interventional artificial stent valve and the stent valve under radial compression are relatively hard and poor in flexibility. It is not easy to pass through the aortic arch and cannot be aligned with the natural aortic valve orifice.
2、即便在x光透视帮助下，介入式人工支架瓣膜和它的输放装置的轴向上下游定位也因对解剖位置的判断不准和血流冲击下的人工瓣膜不稳定而变得不容易。介入式人工主动脉瓣膜如果位置偏上游可影响二尖瓣，如果位置偏下游可堵阻冠状动脉开口。2. Even with the help of X-ray fluoroscopy, the axial upstream and downstream positioning of the interventional artificial stent valve and its delivery device becomes uncertain due to the inaccurate judgment of the anatomical position and the instability of the artificial valve under the impact of blood flow. easy. The interventional prosthetic aortic valve can affect the mitral valve if it is positioned upstream, and it can block the coronary artery opening if it is positioned downstream.
3、介入式主动脉瓣人工支架瓣膜和它的输放装置的旋转方向定位没能解决。介入式人工主动脉瓣膜如果旋转位置不对可堵阻冠状动脉开口。3. The rotation direction positioning of the interventional aortic valve artificial stent valve and its delivery device cannot be solved. The interventional prosthetic aortic valve can block the opening of the coronary artery if it is rotated incorrectly.
4、自扩型人工支架瓣膜高度压缩下，鞘管的回退会遇到很大的阻力。退鞘管的阻力和困难还会使操作者将已定好位的人工支架瓣膜移位。4. When the self-expanding artificial stent valve is highly compressed, the retraction of the sheath will encounter great resistance. The resistance and difficulty of withdrawing the sheath can also cause the operator to displace the fixed artificial stent valve.
5、在释放过程中，支架瓣膜逐渐半扩张到全扩张，所需时间超过一个心跳周期。扩张的支架瓣膜会阻碍血流，支架瓣膜也可因血流冲击而使其位置改变。特别是球囊扩张型人工支架瓣膜在球囊扩张过程中完全阻断血流。5. During the release process, the stent valve gradually expands from half to full expansion, and the required time exceeds one heartbeat cycle. The expanded stent valve can obstruct blood flow, and the stent valve can also change its position due to the impact of blood flow. In particular, balloon-expandable prosthetic stent-valves completely block blood flow during balloon expansion.
6、如果病人已有冠状动脉搭桥(Coronary Artery Bypass)，已植入的人工支架瓣膜不应该在升主动脉处影响搭桥开口的血液灌流。6. If the patient has coronary artery bypass (Coronary Artery Bypass), the implanted artificial stent valve should not affect the blood perfusion of the bypass opening at the ascending aorta.
7、Jacques SEGUIN和Philippe BONHOEFFER的主动脉瓣自扩型支架瓣膜如能成功植入，虽然术后不会马上影响冠状动脉的灌流，但是支架中部在主动脉根部不贴血管壁，让血流从支架网眼中流过，一方面会有血栓形成的可能；另一方面会影响或妨碍未来可能的冠状动脉介入诊断和治疗。7. If the aortic valve self-expanding stent valve of Jacques SEGUIN and Philippe BONHOEFFER can be successfully implanted, although the perfusion of the coronary artery will not be affected immediately after the operation, the middle part of the stent will not stick to the vessel wall at the aortic root, so that the blood flow Flow through the stent mesh, on the one hand, may cause thrombus formation; on the other hand, it will affect or hinder possible future diagnosis and treatment of coronary artery intervention.
8、释放扩张后的支架瓣膜的固定也存在以下问题：8. There are also the following problems in the fixation of the stent valve after release and expansion:
a)收缩期和舒张期血流冲击会使固定不好的人工支架瓣膜移动。a) The impact of blood flow during systole and diastole will move the poorly fixed artificial stent valve.
b)有些主动脉瓣关闭不全的病人其主动脉根部术前已有病理性扩张，需要很大的支架瓣膜才能与其吻合固定。b) Some patients with aortic valve insufficiency have pathological expansion of the aortic root before surgery, and a large stent valve is needed to anastomose and fix it.
c)有些病人在人工支架瓣膜植入后局部会有解剖性变化，如扩张，使不能相应变化的支架瓣膜失去有效固定。c) Some patients will have local anatomical changes after the artificial stent valve is implanted, such as expansion, so that the stent valve that cannot be changed accordingly will lose effective fixation.
9、扩张固定后的人工支架瓣膜在很多情况下有瓣周漏(Para valvularleaks)，即血液从支架瓣膜和血管壁之间漏过。9. The artificial stent valve after expansion and fixation has paravalvular leaks (Para valvular leaks) in many cases, that is, blood leaks between the stent valve and the vessel wall.
11、如果为了固定好而采用大直径支架瓣膜，瓣叶联合点(Commi ssure)会承受很大应力，造成瓣膜叶联合点撕损。11. If a large-diameter stent valve is used for fixation, the commissure of the leaflets will bear a lot of stress, resulting in tearing of the commissure of the valve leaflets.
发明内容Contents of the invention
本发明的目的，在于克服现有技术存在的上述问题，提供一种新型结构的人工心脏支架瓣膜的输放装置，既可用于介入式治疗，也可用于微创手术治疗。The purpose of the present invention is to overcome the above-mentioned problems existing in the prior art, and to provide a delivery device for an artificial heart stent valve of a novel structure, which can be used for both interventional treatment and minimally invasive surgical treatment.
本发明的目的是这样实现的：一种人工心脏支架瓣膜的输放装置，其特点是，包括导管头、内管、近端控制器、中管、导丝管、外保护机构、至少一根锁定丝和至少一根支架拉线；所述的导管头、内管和近端控制器顺序连成一体并相互连通，所述的中管套装在内管上可沿内管滑动，所述的导丝管设置在连成一体的导管头、内管和近端控制器内，所述的外保护机构封套在内管和中管外并可移动至内管的远端，所述的锁定丝和支架拉线分别穿设在连成一体的内管和近端控制器内。The object of the present invention is achieved like this: a kind of delivery device of artificial heart stent valve, it is characterized in that, comprises catheter tip, inner tube, near-end controller, middle tube, guide wire tube, outer protection mechanism, at least one locking wire and at least one support pull wire; the catheter head, the inner tube and the proximal controller are sequentially integrated and communicated with each other; the middle tube is set on the inner tube and can slide along the inner tube; the guide The wire tube is arranged in the integrated catheter head, inner tube and proximal controller, the outer protection mechanism is enveloped outside the inner tube and the middle tube and can move to the far end of the inner tube, the locking wire and The support stay wires are respectively passed through the connected inner tube and the near-end controller.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的导管头为流线型空心圆锥体结构，其大端为后端与内管远端相连通，其小端为前端设有导丝孔与导丝管连通，导管头的前段设有至少一个侧开口与内管相通，导管头由柔软的高分子材料构成，其中含有不透X线材料，或嵌有不透X线标志。A delivery device for an artificial heart stent valve, characterized in that the catheter head is a streamlined hollow cone structure, its large end is connected to the rear end of the inner tube, and its small end is provided with a guide wire at the front end The hole communicates with the guide wire tube, and the front section of the catheter head is provided with at least one side opening to communicate with the inner tube. The catheter head is made of soft polymer material, which contains radiopaque material, or is embedded with radiopaque signs.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为一长管形结构，包括用于与人工心脏支架瓣膜相连的内管远段、弓弧形的内管中段和与近端控制器连通的内管近段，内管内设有至少一个让各种丝、线通过的孔腔，内管远段设有至少一个侧开口。A kind of delivery device of artificial heart stent valve, it is characterized in that, described inner tube is a long tube-shaped structure, comprises the far section of inner tube that is used to link to each other with artificial heart stent valve, the arcuate inner tube middle section and The proximal section of the inner tube communicated with the proximal controller, the inner tube is provided with at least one cavity through which various wires and threads pass, and the far section of the inner tube is provided with at least one side opening.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为单孔内管，内管内只设有一个大圆形通用孔腔，所述的导丝管设置在该孔腔内并可沿内管滑动。A delivery device for an artificial heart stent valve is characterized in that the inner tube is a single-hole inner tube, and the inner tube is only provided with a large circular general-purpose cavity, and the guide wire tube is arranged in the cavity inside and can slide along the inner tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为单孔内管，内管内只设有一个大圆形通用孔腔，在该孔腔内设置所述的导丝管，还设有一个拉线管和一个锁定丝管，所述导丝管、拉线管和锁定丝管之间能相互滑动。A delivery device for an artificial heart stent valve is characterized in that the inner tube is a single-hole inner tube, and the inner tube is only provided with a large circular general-purpose cavity, and the guide wire is set in the cavity The tube is also provided with a pull wire tube and a locking wire tube, and the guide wire tube, the pull wire tube and the locking wire tube can slide mutually.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为双孔内管，紧靠内管边缘设有一小圆形导丝管，其余部分形成一个大半月形通用管，所述小圆形导丝管和大半月形通用管之间粘连固定不能滑动。A device for delivery of an artificial heart stent valve is characterized in that the inner tube is a double-hole inner tube, a small circular guide wire tube is arranged close to the edge of the inner tube, and the remaining part forms a large half-moon-shaped general-purpose tube, Adhesion and fixation between the small circular guide wire tube and the large half-moon-shaped universal tube cannot slide.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为三孔内管，紧靠内管边缘设有一小圆形导丝管，其余部分等分成两半，形成两个形状对称相同的通用管，所述小圆形导丝管和两个形状对称相同的通用管之间粘连固定不能滑动。A delivery device for an artificial heart stent valve is characterized in that the inner tube is a three-hole inner tube, and a small circular guide wire tube is arranged close to the edge of the inner tube, and the remaining part is divided into two halves to form two The general-purpose tubes with the same symmetrical shape, the small circular guide wire tube and the two general-purpose tubes with the same symmetrical shape are fixed by adhesion and cannot slide.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为四孔内管，紧靠内管边缘设有一小圆形导丝管，导丝管对面的内管边缘设有一小圆形锁定丝管，其余部分等分成两半，形成两个形状对称相同的通用管，各管之间粘连固定不能滑动。A delivery device for an artificial heart stent valve is characterized in that the inner tube is a four-hole inner tube, a small circular guide wire tube is provided close to the edge of the inner tube, and a small circular guide wire tube is arranged on the edge of the inner tube opposite the guide wire tube. The small circular locking wire tube is divided into two equal halves to form two general-purpose tubes with the same symmetrical shape, and the tubes are fixed by adhesion and cannot slide.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的设在内管远段的侧开口为三个，包括远侧开口、中侧开口和近侧开口，三个侧开口均在内管的同一平面和同一侧边。A delivery device for an artificial heart stent valve is characterized in that the described side openings located at the far section of the inner tube are three, including a far side opening, a middle side opening and a proximal opening, and the three side openings are all located at the Same plane and same side of inner tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的侧开口的周边设有加强环，该加强环由强度高、摩擦性好的金属材料或强度高、摩擦性好的高分子材料构成，当加强环由金属材料构成时，被用作不透X线标志。A delivery device for an artificial heart stent valve is characterized in that the periphery of the side opening is provided with a reinforcement ring, and the reinforcement ring is made of a metal material with high strength and good friction or a polymer material with high strength and good friction. Material construction, used as a radiopaque marker when the reinforcing ring is constructed of a metallic material.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管的中层夹有编织加强网，内管侧开口开在编织加强网的一个网格中。A delivery device for an artificial heart stent valve is characterized in that the middle layer of the inner tube is clamped with a braided reinforcing net, and the side opening of the inner tube is opened in a grid of the braided reinforcing net.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的内管为螺旋形的弹簧管，弹簧管远段的弹簧丝在局部构成半环或整环，形成内管的远侧开口、中侧开口和近侧开口。A delivery device for an artificial heart stent valve is characterized in that the inner tube is a spiral spring tube, and the spring wire at the far end of the spring tube partially forms a half-ring or a full ring to form the far-side opening of the inner tube , the medial opening and the proximal opening.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的螺旋形的弹簧管外包有高分子材料管，高分子材料管在相应于弹簧管的半环或整环处设有开口。A delivery device for an artificial heart stent valve is characterized in that the spiral spring tube is covered with a polymer material tube, and the polymer material tube is provided with an opening corresponding to the half ring or the whole ring of the spring tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的近端控制器为树枝状结构，包括一个主干管及与主干管连通的至少一个拉线支管、至少一个锁定丝支管、一个冲洗和造影支管和至少一个导丝支管。A delivery device for an artificial heart stent valve, characterized in that the proximal controller is a dendritic structure, including a main pipe and at least one backguy branch pipe communicated with the main pipe, at least one locking wire branch pipe, a washing and contrast branch and at least one guidewire branch.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的拉线支管斜向连接在近端控制器主干管的一侧，并与内管的侧开口位于同一侧边，拉线支管内设有防血液倒流膜，膜中间设有让拉线通过的针孔，拉线支管内设有拉线紧固器可将拉线的某一特定位置固定在拉线支管上。A kind of delivery device of artificial heart stent valve, it is characterized in that, described backguy branch pipe is obliquely connected to one side of the main pipe of near-end controller, and is positioned at the same side with the side opening of inner tube, and backguy branch pipe is equipped with There is an anti-blood backflow film, and there is a pinhole in the middle of the film for the cable to pass through, and a cable fastener is provided in the cable branch tube to fix a certain position of the cable on the cable branch tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的拉线支管为三个，三个拉线支管分别斜向连接在近端控制器主干管的同一侧，并按前后顺序分别对应于远端拉线、中段拉线和近端拉线，形成远端拉线支管、中段拉线支管和近端拉线支管。A delivery device for an artificial heart stent valve is characterized in that there are three backguy branch pipes, and the three backguy branch pipes are obliquely connected to the same side of the main pipe of the proximal controller respectively, and respectively correspond to The far-end backguy, the middle section of the backguy and the proximal backguy form the far-end backguy branch, the middle section of the backguy branch and the proximal backguy branch.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的锁定丝支管斜向活动连接在近端控制器主干管的一侧，在主干管的与锁定丝支管的连接口上设有防血液返流膜，膜中间设有让锁定线通过的针孔，锁定丝支管内设有一滑动杆，滑动杆的前端与锁定丝相连，滑动杆的后端伸出管外形成操作手柄，滑动杆的中部开有一槽，锁定丝支管上相应于该槽的位置设有远端定位销孔和近端定位销孔，两定位销可分别穿过锁定丝支管上的两定位销孔和滑动杆上的槽将锁定丝支管和滑动杆相连，通过固定或解除定位销可以确定滑动杆及其连接的锁定丝是否滑动并控制其滑动距离。A delivery device for an artificial heart stent valve is characterized in that the locking wire branch pipe is obliquely movably connected to one side of the main pipe of the proximal controller, and an anti-locking wire is provided on the connection port of the main pipe and the locking wire branch pipe. The blood regurgitation membrane has a pinhole in the middle of the membrane for the locking wire to pass through, and a sliding rod is arranged in the locking wire branch tube, the front end of the sliding rod is connected with the locking wire, and the rear end of the sliding rod extends out of the tube to form an operating handle There is a slot in the middle of the locking wire branch tube, and the position corresponding to the slot is provided with a distal positioning pin hole and a proximal positioning pin hole. The two positioning pins can pass through the two positioning pin holes on the locking wire branch tube and the sliding rod respectively. The groove of the locking wire branch pipe is connected with the sliding rod, and whether the sliding rod and the locking wire connected thereto can slide and control its sliding distance can be determined by fixing or releasing the positioning pin.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的锁定丝支管为两个，两个锁定丝支管分别斜向连接在近端控制器主干管的同一侧，并分别对应于两锁定丝。A delivery device for an artificial heart stent valve is characterized in that there are two locking wire branch pipes, and the two locking wire branch pipes are connected obliquely to the same side of the proximal controller trunk pipe respectively, and correspond to the two respectively. Lock wire.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的中管的近端接近近端控制器，远端不到内管的近侧开口，在中管的近段连接有一个侧管，中管内设有一根中管拉线，中管拉线的远端固定在中管的远端端口，中管拉线的近端从中管近段的侧管引出，中管拉线的远端固定点和中管近段的侧管设置在同一平面和同一边，在中管近端的端口和侧管的端口各安有一个紧缩环，该紧缩环放松时可沿内管滑动，紧缩时固定在内管上的一定位置。A delivery device for an artificial heart stent valve is characterized in that the proximal end of the middle tube is close to the proximal controller, the far end is less than the proximal opening of the inner tube, and a side tube is connected to the near section of the middle tube. The middle tube is provided with a middle tube stay wire, the far end of the middle tube stay wire is fixed on the far end port of the middle tube, the proximal end of the middle tube stay wire is drawn out from the side tube of the near section of the middle tube, the far end of the middle tube stay wire is fixed at the The side tubes in the proximal section of the middle tube are arranged on the same plane and on the same side, and a tightening ring is respectively installed at the port at the proximal end of the middle tube and the port of the side tube. The tightening ring can slide along the inner tube when loosened, and is fixed inside a certain position on the tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的中管略带一定锥度，远段较细，近段较粗，使输放装置同时获得近段推动性和中远段弯曲性。A delivery device for an artificial heart stent valve, which is characterized in that the middle tube is slightly tapered, the distal section is thinner, and the proximal section is thicker, so that the delivery device can simultaneously obtain near-section pushability and middle-to-distal section bending .
一种人工心脏支架瓣膜的输放装置，其特点是，所述的导丝管的远端与导管头连通，近端与近端控制器上的导丝支管连通，导丝管在内管中段的部分位于内管中段的凸侧。A delivery device for an artificial heart stent valve is characterized in that the distal end of the guide wire tube communicates with the catheter head, the proximal end communicates with the guide wire branch on the proximal controller, and the guide wire tube is in the middle of the inner tube The part is located on the convex side of the middle section of the inner tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的外保护机构为管状外鞘管，该外鞘管的远端管壁内嵌有不透X线标志，近段设有冲洗/造影开口和阀门，近端端口内设有弹性膜，弹性膜中央设有小孔，正常情况下小孔关闭或只有很小的直径，中管穿过时小孔的直径可以扩大，以保证中管滑动和弹性膜不漏血。A delivery device for an artificial heart stent valve, characterized in that the outer protection mechanism is a tubular outer sheath, the distal end of the outer sheath is embedded with an X-ray-opaque mark, and the proximal section is provided with a flushing /Contrast opening and valve, there is an elastic membrane in the proximal port, and a small hole is set in the center of the elastic membrane. Under normal circumstances, the small hole is closed or has only a small diameter. When the middle tube passes through, the diameter of the small hole can be enlarged to ensure The tube slides and the elastic membrane does not leak blood.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的外保护机构为可撕开外保护机构，包括可撕开鞘管和用于临时性收紧可撕开鞘管的鞘管收线以及用于锁定鞘管收线的收线锁丝；可撕开鞘管的远段设有一纵向开口并贯穿远端，纵向开口两侧鞘管上设有多个收线眼，可撕开鞘管的远端直径缩小，构成弹头流线型，可撕开鞘管中近段部分为一完整的管，其直径小于或等于远段的直径；鞘管收线的远端设有收线环穿过内管远段的一个侧开口被收线锁丝卡住，鞘管收线的近端临时固定在近端控制器上，鞘管收线穿过可撕开鞘管上的各收线眼构成收紧结构，并可在抽走收线锁丝后解除；收线锁丝穿设在内管内并可沿内管滑动，其近端从近端控制器引出。A delivery device for an artificial heart stent valve, characterized in that the outer protection mechanism is a tearable outer protection mechanism, including a tearable sheath and a sheath for temporarily tightening the tearable sheath The take-up wire and the take-up lock wire used to lock the sheath take-up; the far section of the tearable sheath is provided with a longitudinal opening and runs through the distal end, and there are multiple take-up eyes on the sheath on both sides of the longitudinal opening, which can be torn The diameter of the distal end of the unsheathed tube is reduced to form a streamlined bullet, and the middle and proximal part of the sheath tube can be torn off to form a complete tube, and its diameter is smaller than or equal to the diameter of the distal part; the distal end of the sheath tube is provided with a take-up ring A side opening passing through the far section of the inner tube is blocked by the wire locking wire, the proximal end of the sheath wire is temporarily fixed on the proximal controller, and the sheath wire passes through each wire on the tearable sheath The eye forms a tightening structure, which can be released after the take-up lock wire is pulled away; the take-up lock wire is passed through the inner tube and can slide along the inner tube, and its proximal end is drawn out from the proximal controller.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的可撕开鞘管为管状布管结构，其管壁为密封的管壁。A delivery device for an artificial heart stent valve is characterized in that the tearable sheath tube is a tubular tube structure, and its tube wall is a sealed tube wall.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的可撕开鞘管为管状网管结构，其管壁为有网眼的管壁。A delivery device for an artificial heart stent valve is characterized in that the tearable sheath tube is a tubular mesh structure, and its tube wall is a tube wall with mesh.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的外保护机构为可绕结并可解结的压线机构，包括至少一根压线锁丝和一根支架压线，二者组成可绕结并可解结的压线机构，可将支架瓣膜临时性径向压缩。A delivery device for an artificial heart stent valve is characterized in that the outer protection mechanism is a crimping mechanism that can be wound and unknotted, including at least one crimping wire and a stent crimping wire, two The former constitutes a crimping mechanism that can be wound and unknotted, and can temporarily compress the stent valve radially.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的压线锁丝贯穿内管并可沿内管滑动，其近端从近端控制器的一个支管引出；所述的支架压线的近端从近端控制器的一个支管引出，其远端设有线环，远端线环穿过内管的一个侧开口进入内管被一压线锁丝卡住，在远端线环进入内管侧开口前，支架压线可选择性在支架瓣膜外面经过，或穿过支架瓣膜上没有密封膜的部分，在穿过支架瓣膜上没有密封膜的部分时中途被同一或不同的压线锁丝穿过卡住，形成绕结可对支架瓣膜实施临时性径向压缩并可在抽走压线锁丝后解结。A delivery device for an artificial heart stent valve is characterized in that the crimping wire lock wire runs through the inner tube and can slide along the inner tube, and its proximal end is drawn from a branch pipe of the proximal controller; The proximal end of the wire is led out from a branch pipe of the proximal controller, and a wire loop is provided at the far end. Before entering the side opening of the inner tube, the stent crimping line can optionally pass outside the stent valve, or pass through the part of the stent valve without a sealing membrane, and be pressed by the same or different pressure halfway through the part of the stent valve without a sealing membrane. The wire lock wire is threaded through the entrapment, forming a knot that temporarily compresses the stent-valve radially and can be unknotted after the wire lock wire is withdrawn.
一种人工心脏支架瓣膜的输放装置，其特点是，还包括侧导丝管，所述的侧导丝管起自内管远段中部的外侧并与内管远段相连，向内管近侧方向延伸到内管中段，也可以延伸到内管近段或近端控制器上，侧导丝管的远端处在内管的远侧开口与近侧开口之间并向外弯折，形成的端口方向与内管的侧开口方向成一定角度。A delivery device for an artificial heart stent valve is characterized in that it also includes a side guide wire tube, and the side guide wire tube starts from the outside of the middle part of the far section of the inner tube and is connected to the far section of the inner tube, and is close to the inner tube. The side direction extends to the middle section of the inner tube, and can also extend to the proximal section of the inner tube or the proximal controller. The distal end of the side guide wire tube is between the distal opening and the proximal opening of the inner tube and is bent outward. The direction of the formed port is at a certain angle to the direction of the side opening of the inner tube.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的侧导丝管为一根，与可撕开外保护机构或可绕结并可解结的压线机构配合设置。A delivery device for an artificial heart stent valve is characterized in that the side guide wire tube is one, which is set in cooperation with a tearable outer protection mechanism or a thread-pressing mechanism that can be wound and unknotted.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的侧导丝管为两根，与可绕结并可解结的压线机构配合设置，两侧导丝管之间成120度转角布置。A delivery device for an artificial heart stent valve is characterized in that the side guide wire tubes are two, which are arranged in cooperation with a crimping mechanism that can be wound and unknotted, and the distance between the guide wire tubes on both sides is 120°. Degree corner arrangement.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的锁定丝贯穿内管，其远段穿过一根或多根支架拉线的拉线环将一根或多根支架拉线锁定，近端与近端控制器锁定丝支管中的滑动杆相连。A delivery device for an artificial heart stent valve is characterized in that the locking wire runs through the inner tube, and its far section passes through the backguy ring of one or more stent backguys to lock one or more stent backguys, and close The end is connected to the sliding rod in the locking wire branch of the proximal controller.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的锁定丝为两根，两根锁定丝分别锁定一根或多根支架拉线并分别与近端控制器的两个锁定丝支管中的滑动杆相连。A kind of delivery device of artificial heart stent valve, it is characterized in that, described locking wire is two, and two locking wires respectively lock one or more stent pull wires and respectively connect with two locking wire branches of near-end controller Connected to the sliding rod in.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的支架拉线穿过内管的孔腔，其远端设有一个拉线环，其近端从近端控制器的拉线支管引出，其远段从内管的一个侧开口引出形成支架拉线的外段，支架拉线的外段环绕网状支架一圈后进入内管的同一个侧开口，并通过其远端的拉线环被锁定丝锁定。A kind of delivery device of artificial heart stent valve, it is characterized in that, described stent backguy passes through the cavity of inner tube, its far-end is provided with a backguy ring, and its proximal end is drawn from the backguy branch pipe of near-end controller, Its far section is led out from a side opening of the inner tube to form the outer section of the stent stay wire. The outer section of the stent stay wire wraps around the mesh stent and enters the same side opening of the inner tube, and is locked by the pull wire loop at the far end. locking.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的支架拉线的外段在环绕网状支架时分别穿过网状支架的可变形单元的开口、开放式线拐、密封式线眼和柔性联结环，构成一个套索。A delivery device for an artificial heart stent valve is characterized in that the outer section of the support backguy passes through the opening of the deformable unit of the mesh stent, the open wire crutches, and the sealed wire respectively when surrounding the mesh stent. The eye and the flexible coupling ring form a noose.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的支架拉线为三根，三根支架拉线的近端分别从近端控制器的三个拉线支管引出，三根支架拉线的远端分别在内管的三个侧开口内被同一或不同的锁定丝锁定。A kind of delivery device of artificial heart stent valve, it is characterized in that, described support backguy is three, and the proximal end of three support backguys is respectively drawn from three backguy branch pipes of near-end controller, and the far-end of three support backguys is respectively in The three side openings of the inner tube are locked by the same or different locking wires.
一种人工心脏支架瓣膜的输放装置，其特点是，所述的三根支架拉线中，从近端控制器的近端拉线支管引出的拉线，其远端连接在内管的近侧开口内，从近端控制器的中段拉线支管引出的拉线，其远端连接在内管的中侧开口内，从近端控制器的远端拉线支管引出的拉线，其远端连接在内管的远侧开口内。A kind of delivery device of artificial heart stent valve, it is characterized in that, among described three support backguys, the backguy that draws from the near-end backguy branch pipe of near-end controller, its far-end is connected in the near side opening of inner tube, The far end of the pull wire drawn from the middle pull wire branch of the near-end controller is connected to the middle opening of the inner tube, and the far end of the pull wire drawn from the far-end pull wire branch of the near-end controller is connected to the far side of the inner tube inside the opening.
一种人工心脏支架瓣膜的输放装置，其特点是，还包括B超探头，该B超探头设置在导管头的后端或设置在内管的远侧开口附近或近侧开口附近，连接B超探头的导线穿过内管从近端控制器引出。A delivery device for an artificial heart stent valve is characterized in that it also includes a B-ultrasound probe, the B-ultrasound probe is arranged at the rear end of the catheter head or near the far side opening or near the proximal opening of the inner tube, connected to the B The wires of the ultra-probe pass through the inner tube and lead out from the proximal controller.
一种人工心脏支架瓣膜的输放装置，其特点是，还包括临时回收线，该临时回收线用于在装配时帮助拉线回到近端控制器。A delivery device for an artificial heart stent valve is characterized in that it also includes a temporary recovery line, which is used to help pull the wire back to the proximal controller during assembly.
本发明的人工心脏支架瓣膜的输放装置由于采用了上述的技术方案，使之与现有技术相比，具有以下的优点和积极效果：The delivery device of the artificial heart stent valve of the present invention has the following advantages and positive effects compared with the prior art due to the adoption of the above-mentioned technical scheme:
1、可使支架瓣膜旋转定位；可使扩张后的支架瓣膜得到有效固定；可减少瓣膜叶磨损；可减少支架拉线的磨擦，防止拉线脱位。1. The stent valve can be rotated and positioned; the expanded stent valve can be effectively fixed; the wear of the valve leaflet can be reduced; the friction of the stent wire can be reduced to prevent the wire dislocation.
2、设有锁定丝使支架瓣膜可在两次心跳之间快速无阻力释放。2. There is a locking wire so that the stent valve can be released quickly and without resistance between two heartbeats.
3、可设有可撕开外保护机构代替较硬的外鞘管对支架瓣膜的输放起保护作用。3. A tearable outer protection mechanism can be provided instead of a harder outer sheath to protect the delivery and release of the stent valve.
4、可设有可绕结并可解结的压线机构代替较硬的外鞘管对支架瓣膜的输放起保护作用。4. A crimping mechanism that can be wound and unknotted can be provided instead of a harder outer sheath to protect the delivery and release of the stent valve.
5、可设有B超探头监测输放装置的输放过程。5. A B-ultrasound probe can be installed to monitor the output and playback process of the output and playback device.
6、设有中管与中管拉线，有利于输放装置通过主动脉弓。6. It is equipped with a middle tube and a middle tube pull wire, which is beneficial for the delivery device to pass through the aortic arch.
7、设有拉线近段临时回收线可在术前帮助拉线回到近端控制器。7. There is a temporary recovery line in the proximal section of the pull wire to help the pull wire return to the proximal controller before the operation.
附图说明Description of drawings
通过以下对本发明人工心脏支架瓣膜及其输放装置的多个实施例结合其附图的描述，可以进一步理解本发明的目的、具体结构特征和优点。其中，附图为：Through the following description of multiple embodiments of the artificial heart stent valve and its delivery device of the present invention in conjunction with the accompanying drawings, the purpose, specific structural features and advantages of the present invention can be further understood. Among them, the attached figure is:
图1a为本发明人工心脏支架瓣膜的输放装置的正视图；Fig. 1 a is the front view of the delivery device of the artificial heart stent valve of the present invention;
图1b为图1a的剖视结构示意图；Fig. 1b is a schematic cross-sectional structure diagram of Fig. 1a;
图1c为图1b的B部剖视放大图；Figure 1c is an enlarged cross-sectional view of part B of Figure 1b;
图1d为图1a所示输放装置中的近端控制器的剖视结构示意图；Fig. 1d is a schematic cross-sectional structural view of the proximal controller in the delivery device shown in Fig. 1a;
图2a、图2b、图2c、图2d为图1a所示人工心脏支架瓣膜的输放装置中的内管沿AA线的剖视结构示意图；Fig. 2a, Fig. 2b, Fig. 2c, Fig. 2d are the cross-sectional structural representations of the inner tube along the AA line in the delivery device of the artificial heart stent valve shown in Fig. 1a;
图2e为本发明人工心脏支架瓣膜的输放装置中的弹簧式内管的远段局部侧视图；Fig. 2 e is the partial side view of the far section of the spring-type inner tube in the delivery device of the artificial heart stent valve of the present invention;
图3a为本发明人工心脏支架瓣膜的输放装置中的中管的平面剖视结构示意图；Fig. 3 a is the plane sectional structure schematic diagram of the middle pipe in the delivery device of the artificial heart stent valve of the present invention;
图3b为本发明人工心脏支架瓣膜的输放装置中的外鞘管的平面剖视结构示意图；Fig. 3 b is the plane sectional structure schematic diagram of the outer sheath tube in the delivery device of the artificial heart stent valve of the present invention;
示意图；schematic diagram;
图4a为本发明人工心脏支架瓣膜在径向压缩下的单层支架瓣膜的正视图；Fig. 4 a is the front view of the single-layer stent valve of the artificial heart stent valve of the present invention under radial compression;
图4b、图4c为本发明人工心脏支架瓣膜中段有外层游离舌的支架瓣膜的正视图，其中，图4b为支架瓣膜径向全压缩，图4c为支架瓣膜体压缩状态下外层舌状物已经释放扩张；Fig. 4b, Fig. 4c are the front views of the stent valve with outer layer free tongue in the middle part of the artificial heart stent valve of the present invention, wherein, Fig. 4b is the radial full compression of the stent valve, and Fig. 4c is the outer layer tongue shape under the compressed state of the stent valve body The substance has been released and expanded;
图4d为图4a的C-C向视图；Fig. 4d is the C-C direction view of Fig. 4a;
图4e为内管中段横切后，图4b的上下方向俯视图；Fig. 4e is a top view of Fig. 4b in the up and down direction after the middle section of the inner pipe is cut across;
图4f为内管中段横切后，图4c的上下方向俯视图；Fig. 4f is a top view of Fig. 4c in the up and down direction after the middle section of the inner pipe is cut across;
图5a、图5b、图5c、图5d为本发明人工心脏支架瓣膜的输放装置中，内管远段含相关结构件的三维侧视图。其中，图5a、图5b、图5d中的支架瓣膜仅在远端和近端显示。图5a为单根锁定丝配三根支架拉线，图5b中有两根锁定丝，其中一锁定丝按顺序控制远近二根支架拉线，另一锁定丝单独控制中间支架拉线。图5c、图5d为支架瓣膜装配过程图，其中，图5c显示装配回收线和已锁住的拉线，但没有支架瓣膜，图5d显示支架瓣膜装配过程：Fig. 5a, Fig. 5b, Fig. 5c, and Fig. 5d are three-dimensional side views of the distal section of the inner tube containing related structural parts in the delivery device of the artificial heart stent valve of the present invention. Wherein, the stent valves in Fig. 5a, Fig. 5b and Fig. 5d are only shown at the distal end and the proximal end. Figure 5a shows a single locking wire with three support stay wires, and Figure 5b has two lock wires, one of which controls the two support stay wires in sequence, and the other lock wire independently controls the middle support stay wires. Figure 5c and Figure 5d are diagrams of the assembly process of the stent valve, wherein Figure 5c shows the assembly recovery line and the locked pull wire, but there is no stent valve, and Figure 5d shows the assembly process of the stent valve:
-支架远端：拉线准备穿过支架密封式线眼和柔性联结环；- The distal end of the stent: the pull wire is ready to pass through the stent sealed eyelet and flexible coupling ring;
-支架中部：拉线已穿过支架密封式线眼和柔性联结环，重新回收支架瓣膜内侧，准备被拉线近段临时回收线拉到近端控制器外；-Middle part of the stent: the pull wire has passed through the stent sealed wire eye and the flexible coupling ring, and is recovered inside the stent valve, ready to be pulled out of the proximal controller by the temporary recovery wire at the proximal section of the pull wire;
-支架近端：拉线已被装配回收线拉到近端控制器外；- Proximal end of the bracket: the pull wire has been pulled out of the proximal controller by the assembly recovery line;
图6a、图6b、图6c为本发明人工心脏支架瓣膜的输放装置中，带一个侧导丝管的内管远段侧视图，其中，图6a、图6b中的内管及支架瓣膜外包有管状布管结构的可撕开鞘管，开口上有鞘管收线；图6c中的内管及支架瓣膜外包有管状网管结构的可撕开鞘管，开口上有鞘管收线；Fig. 6a, Fig. 6b, and Fig. 6c are side views of the distal section of the inner tube with a side guide wire tube in the delivery device of the artificial heart stent valve of the present invention, wherein, the inner tube and the stent valve outsourcing in Fig. 6a and Fig. 6b A tear-off sheath with a tubular tube structure, with a sheath take-up on the opening; the inner tube and stent valve in Figure 6c are covered with a tear-off sheath with a tubular network structure, and a sheath take-up on the opening;
图7为本发明人工心脏支架瓣膜的输放装置中，带两个侧导丝管的内管远段的侧视图，支架瓣膜外有绕结并可被解结的压线。Fig. 7 is a side view of the distal section of the inner tube with two side wire guide tubes in the delivery device for the artificial heart stent valve of the present invention, and the stent valve has crimping wires that are wound around the knot and can be unknotted.
具体实施方式Detailed ways
参见图1至图7，本发明的人工心脏支架瓣膜的输放装置2包括：内管51、导丝管61、导管头65、支架拉线70、锁定丝75、近端控制器80、中管88、外保护机构90、92、96，还可以包括B超探头87和侧导丝管99。Referring to Fig. 1 to Fig. 7, the
参见图1a，配合参见图2a、图2b、图2c、图2d，本发明的人工心脏支架瓣膜的输放装置2中的内管51为一长管形结构。截面可为圆形。内管51可由弹性好，强度高的高分子材料构成。内管51颜色透明或半透明有利于术前检查排气泡。内管51长度为80-150cm，其近端511在体外，远端512到达心脏自然瓣膜的位置。内管远端512与导管头65相连。内管孔腔52、54、54’与导管头65的锥形薄管腔651相连。内管51的结构可有不同方案。内管51内可有一个或多个远近相通的孔腔52、53、54、54’。Referring to Fig. 1a, with reference to Fig. 2a, Fig. 2b, Fig. 2c, Fig. 2d, the
参见图2a，内管51的结构可以为单孔内管51，单孔内管51只有一个大圆形通用孔腔52。在大圆形通用孔腔52内可以置有一个或多个导丝管61，一个或多个拉线70和一个或多个锁定丝75。它们(61、70、75)之间可以相互滑动。大圆形通用孔腔52内还可置有一个或一个以上的导丝管61、拉线管71、锁丝管76，这样各线各丝进相应的管互相之间不交叉。单孔管内多个小管61、71、76组合为一个多孔管，各管之间可以滑动。Referring to FIG. 2 a , the structure of the
参见图2e，内管51也可以由螺旋形的弹簧57构成。弹簧57可以由单丝571构成，也可以由多丝构成。弹簧丝571的直径等于壁厚，内外径可以变化，远段较细，中近段较粗。弹簧丝571可在局部构成半环572d、572p或整环572c，相当于远侧开口516d、近侧开口516p和中侧开口516c。弹簧57的步距可以不同：1、等于丝直径，弹簧只能延长(拉簧)；2、大于丝直径，弹簧可以延长或缩短(压簧)。弹簧57外可有高分子材料管58保护，达到：降低外摩擦；不外漏液体；高分子材料管至少二端与弹簧紧密相连，弹簧可以保证抗折性，但没有轴向延伸。Referring to FIG. 2 e , the
参见图2b，内管51也可以为双孔内管，双孔内管51有两个管腔53、54。一个小圆形0.035”导丝管腔53供0.035”导丝通过，相当于导丝管61，和一个大半月形普通管腔54供支架拉线70、锁定丝75及可能的支架压线98和压线锁丝97通过。两管腔53、54之间为偏心分布，各管之间粘连固定不滑动。Referring to FIG. 2 b , the
参见图2c、图2d，内管51也可以是多孔内管，多孔内管51有多个管腔53、54’。多孔管是在两孔管基础上将大半月形管腔54再分为两个或多个小管腔54’。一个小圆形0.035”导丝管腔53供0.035”导丝通过，相当于导丝管61，和多个小管腔54’供支架拉线70、锁定丝75及可能的支架压线98和压线锁丝97分别在各自的管腔通过。各管之间粘连固定不滑动。Referring to Fig. 2c and Fig. 2d, the
参见图1a、图1b，配合参见图5a、图5b、图5c、图5d、图6a、图6b、图6c和图7，内管远段513位于内管远端512的近侧。装配输送时内管远段513位于人工支架瓣膜1内侧，用于与人工支架瓣膜1相连。它的内径为1.5-2.5mm左右，外径为1.8-3.0mm左右，其长度略长于压缩状态下的人工支架瓣膜1。内管远段513在远近不同水平上有一个或以上侧开口516d、516c、516p。远侧开口516d、中侧开口516c和近侧开口516p均在内管的同一平面和同一边，如凹面边517上。远侧开口516d、中侧开口516c和近侧开口516p分别与人工支架瓣膜1的上游端184、中段15、下游端134相对。远侧开口516d和近侧开口516p之间的距离约等于支架瓣膜1压缩下的长度。侧开口516d、516c、516p或与单孔内管51的大圆形通用孔腔52相通，或与双孔内管51的大半月形通用管腔54相通，或与多孔内管51的支架拉线管腔、锁定丝管腔、支架压线管腔和压线锁丝管腔54’同时相通。远近两个侧开口516d、516p可以是单独供给支架拉线70走的单独开口，也可以是支架拉线70和支架压线98合用的统一开口。侧开口516d、516c、516p用于内管孔腔52、54、54’内拉线70出进和气液体排出，如术中造影。同一水平上的侧开口也可以有一个或多个。内管侧开口516d、516c、516p的周边有加强环55，由强度高、摩擦性好的材料如金属或高分子材料构成。可增加拉线滑动，减少拉线切割内管可能性。金属材料的加强环55可构成不透X线标志。Referring to FIG. 1a, FIG. 1b, and referring to FIG. 5a, FIG. 5b, FIG. 5c, FIG. 5d, FIG. 6a, FIG. 6b, FIG. 6c and FIG. The
内管中层可有编织加强网56，内管侧开口516d、516c、516p可开在编织加强网56的一个网格中。The middle layer of the inner tube may have a braided reinforcing
继续参见图1a、图1b，内管中段514位于内管远段513的近侧。内管中段514已预先制成弓弧形，构成了内管中段凹面边517和凸面边518。呈弓弧形的内管中段514构成了基准平面。内管中段514不与人工支架瓣膜1相连，其内径和外径可以大于内管远段513的内径和外径，但其外径应小于压缩状态人工支架瓣膜的外径。内径增加后，其内的拉线70、锁定丝75之间的摩擦减小。内外径增加后，内管51抗弯曲性增强。在外力作用下，中段自然的弓弧形可以变形。Continuing to refer to FIG. 1 a and FIG. 1 b , the
继续参见图1a、图1b，内管近段515为直管，是内管中段514向近侧的延伸。内管中段514和内管近段515可以是弹簧管或编织加强管56。内管的近端511与近端控制器80相连。Continuing to refer to FIG. 1 a and FIG. 1 b , the
参见图1a，配合参见图2a、图2b、图2c、图2d，本发明的人工心脏支架瓣膜的输放装置2中的导丝管61可以有二种方案：1、在一孔腔内管51内设有一独立的内径可通0.035”外径导丝的导丝管61，该导丝管61一直与内管轴线平行，并分别从内管远端512和近端511出来，在内管中段514位于凸侧518，导丝管远端611与导管头65的导丝管孔652相连，近端与近端控制器80上的导丝支管86相连；2、在两孔腔或多孔腔内管51内设有一个小圆形导丝腔53，形成一粘连固定在内管上的导丝管61，其内径可通0.035”外径导丝，该小圆形导丝腔53在内管中段514位于凸侧518，小圆形导丝腔远端531与导管头65的导丝管孔652相连，近端532与近端控制器80上的导丝支管86相连。Referring to Fig. 1a, cooperate referring to Fig. 2a, Fig. 2b, Fig. 2c, Fig. 2d, the
参见图1c，配合参见图1a、图1b，本发明的人工心脏支架瓣膜的输放装置2中的导管头65位于内管远端512的远侧，可以是内管的一部分。导管头65为流线型空心圆锥体结构，其大端654为后端与内管远端512相连通，其小端653为前端设有导丝孔652与导丝管61或小圆形导丝腔53相通，小端653为一锥形空心薄管，有软而薄的管壁655。导管头65的前段设有一到多个侧开口657与内管远近相通的孔腔52、54、54’相通，供冲洗后排气、穿锁丝。大端654与内管远端512相连。导管头65由柔软的高分子材料构成，可含有不透X线材料，或嵌有不透X线标志。Referring to Fig. 1c, referring to Fig. 1a and Fig. 1b together, the
参见图1a、图1b、图1d，配合参见图4a、图4b、图4c、图4d、图5a、图5b、图5c、图5d，本发明的人工心脏支架瓣膜的输放装置2中的支架拉线70是由高分子材料或金属材料制成的细线。要求弹性好，没有或很小塑性变形，在拉力下没有或只有很小延伸，没有或只有很小冷塑变形。一个支架拉线70有一个拉线环701，拉线环701位于拉线的远端702，可以是一个360°密封的细环或一个双线末端180°打折的开放式半环，拉线环701位于内管远侧开口516d、中侧开口516c和近侧开口516p中的一个之内并被一个锁定丝75卡住。拉线外段703为拉线环701的延续，位于前述内管侧开口516d、516c、516p之外，拉线外段703可以为双线，也可以变成为单线，为装配人工支架瓣膜1于输放装置2上，拉线外段703需要穿过支架10的一个可变形单元101开口或者开放式线拐102或者密封式线眼103，到达支架外侧至少一次，经过其他可变形单元101，穿过支架瓣膜柔性联结环41，再穿过同一或不同可变形单元101开口或者开放式线拐102或者密封式线眼103，回到支架内侧，构成一个套索704。拉线远段705为拉线外段703向输放装置近端511的延续，拉线远段705回到前述同一或不同内管侧开口516d、516c、516p之内，位于内管远段513之内，拉线远段705也可位于内管远段513特定的拉线孔腔54、54’之内。拉线外段703和拉线远段705之间可以经前述内管侧开口516d、516c、516p滑动。拉线中段706为拉线远段705向输放装置近端511的延续，位于内管中段514内或特定的拉线孔腔54，54’之内，拉线的中段706可以继续是双线，也可以变成单线，也可以从一定长度起与其它材料相连，达到弹性好，同等拉力下不延长。拉线近段707为拉线中段706向输放装置近端511的延续，在内管近段515内向输放装置近端延伸，拉线近段707从近端控制器80中的一个相关拉线支管81d、81c、81p出来。拉线近端708位于相关拉线开口81d、81c、81p之外。每个输放装置2可以有一个或多个支架拉线70、70d、70c、70p。各拉线环701被同一或不同的锁定丝75、75c卡住。各拉线70d、70c、70p的外段703分别从内管远侧开口516d、中侧开口516c和近侧开口516p出来，其拉线环绕支架后再回到各开口内。各拉线近端708从近端控制器80的各拉线支管81d、81c、81p出来。各拉线近端708可在各拉线支管81d、81c、81p外二合一或三合一集中为拉线组合709。Referring to Fig. 1a, Fig. 1b, Fig. 1d, cooperate referring to Fig. 4a, Fig. 4b, Fig. 4c, Fig. 4d, Fig. 5a, Fig. 5b, Fig. 5c, Fig. 5d, in the
参见图1b、图1d，配合参见图2a、图2b、图2c、图2d和图5a、图5b、图5c、图5d，本发明的人工心脏支架瓣膜的输放装置2中可以有一个或二个或多个锁定丝75、75c。每个锁定丝可以锁定一个或多个拉线70、70d、70c、70p。两套或两套以上的锁定丝75、75c可以一起工作，也可以分别单独工作。一个锁定丝75位于内管孔腔52内或特定的锁定丝孔腔54、54’之内。两个或多个锁定丝75、75c可位于同一内管孔腔52、54内或各自特定的锁定丝孔腔54’之内。两个或多个锁定丝75、75c占一个内腔但两个或多个锁定丝75、75c远端长度一样。每个锁定丝75远端751均超过内管远侧开口516d。锁定丝75在远段穿过拉线环701使其不能从内管侧开口516d、516c、516p脱出。锁定丝75向近侧方向延伸，从近端控制器80的锁定丝支管83出来，一个或以上的锁定丝75分别从不同的或同一锁定丝支管83出来。锁定丝近端752与锁定丝支管84的滑杆头844相连。锁定丝75、75c可以在内管51内滑动。Referring to Fig. 1b, Fig. 1d, cooperate to refer to Fig. 2a, Fig. 2b, Fig. 2c, Fig. 2d and Fig. 5a, Fig. 5b, Fig. 5c, Fig. 5d, there can be one or Two or
参见图1d，本发明的人工心脏支架瓣膜的输放装置2中的近端控制器80与内管的近端511相连。近端控制器80包括主干管和连接在其上的多个支管81d、81c、81p、84、85、86。这些支管与内管51通用的孔腔52或各自特定的孔腔54、54’相通。这些支管可以在内管51的轴线上，也可以成角度分叉出来。包括：一个或一个以上的拉线支管81(81d、81c、81p)；一个或一个以上的锁定丝支管84；一个冲洗和造影支管85，与前两种支管81、84及内管通用孔腔52或各自特定的孔腔54、54’相通；一个或一个以上的导丝支管86，导丝支管86可以同上述三种支管81、84、85及内管通用孔腔52或各自特定的孔腔54、54’相通。导丝支管86也可以不同上述三种支管81、84、85及内管通用孔腔52、54相通，而仅与导丝管61内腔相通或多孔内管的小圆形0.035”导丝腔53相通。Referring to Fig. 1d, the
拉线支管81可以有一个，二个或多个。拉线支管81可以在近端控制器80的侧角，也可以在近端控制器80的轴线上的末端。每个拉线支管81一般是走一条拉线，远端拉线70d从远端拉线支管81d出来，中段拉线70c从中段拉线支管81c出来，近端拉线70p从近端拉线支管81p出来。二个或多个拉线70也可以从同一拉线支管81出来。拉线支管81内可以有防血液倒流膜811，由弹性高分子材料构成，中间有一针孔812让拉线70通过。拉线支管81上有拉线紧固器82，可将拉线70的某一特定位置固定在拉线支管81上。拉线支管81与拉线紧固器82的关系可以是公母螺纹关系。拉线被系在公母螺纹之间。拉线紧固器82可以是一个实心的塞子，塞在拉线开口内，将拉线卡在拉线开口上。拉线紧固器82也可以是一个有拉线通道821的旋转塞子822，旋转塞子822及拉线支管81转动后，将拉线卡在拉线支管上。There can be one, two or more backguy branch pipes 81. The pull wire branch pipe 81 can be at the side corner of the near-
近端控制器80上有一个或一个以上的锁定丝支管84。锁定丝支管84可以在近端控制器轴线上末端，也可以在侧面。在主干管与锁定丝支管84的连接口83上设有防血液返流膜831，由弹性高分子材料构成，中间有一针孔832，可以让锁定丝75通过。主干管的连接口83上有连结机构833，如内螺纹，可以和锁定丝支管84的连结机构842，如外螺纹，连结固定。在没有固定的情况下，锁定丝75可以在锁定丝支管84内及内管51内滑动。锁定丝支管84内设有一滑动杆843可以在锁定丝支管84的内腔841内滑动。滑动杆的前端844与锁定丝近端752相连，滑动杆的后端伸出管外形成操作手柄，滑动杆的中部开有一槽，锁定丝支管上相应于该槽的位置设有远端定位销孔和近端定位销孔，两定位销848可分别穿过锁定丝支管上的两定位销孔和滑动杆上的槽将锁定丝支管和滑动杆相连，通过固定或解除定位销可以确定滑动杆及其连接的锁定丝是否滑动并控制其滑动距离。定位销848分为远端定位销848d和近端定位销848p，二个定位销间的距离少于内管相应开口间的距离。一至多个定位销848，可防止锁定丝75向近侧移动。一个定位销848解除后，锁定丝75可向近侧移动一定距离。One or more locking
近端控制器80上设有冲洗造影支管85，其上配有开关851。The
近端控制器80上可以有一个或多个导丝支管86。导丝支管86在近端控制器80末端轴线上。导丝支管86同上述三个支管81、84、85及内管通用孔腔52分离，而只与导丝管61或导丝管腔53相通。导丝支管86上有由弹性高分子材料构成的密封膜，密封膜上有一个针孔，变形后让导丝通过。正常情况下针孔关闭，不漏血。One or more
参见图1c，本发明的人工心脏支架瓣膜的输放装置2中的B超探头87设置在导管头65的后端654上，或设置在内管远段513上，如远侧开口516d附近或近侧开口516p附近可以选择性在设一个或一个以上的B超探头87。B超探头87的导线871贴在内管51上通到近端控制器80并有接头872。Referring to Fig. 1 c, the B-
参见图6a、图6b、图6c、图7，本发明的人工心脏支架瓣膜的输放装置中还设有侧导丝管99，该侧导丝管99与可撕开的外保护机构或与可绕结并可解结的压线机构96配合设置，在内管远段513外侧可以选择性固定一个或一个以上内径可通0.014”外径导丝的侧导丝管99。侧导丝管99起自内管远段513中部的外侧，向近侧511方向延伸至少到内管中段514，也可以到内管近段515或近端控制器80上。侧导丝管99可以与内管中段514和内管近段515相连，也可以不相连。侧导丝管远端991在内管远段513的中部，内管远侧开口516d与内管近侧开口516p之间，没有固定在内管上，有几个毫米的长度可以与内管远段513分离，呈游离活动状态。侧导丝管中部992与内管远段513固定，侧导丝管的近端993在内管近侧开口516p的近侧。侧导丝管管孔994大小至少可让0.014”直径导丝通过。侧导丝管99与内管侧开口516d、516p之间的旋转角度位置可以事先确定，如有两个或两个以上的侧导丝管99，它们之间的旋转角度位置也可以事先确定。不同的侧导丝管远端991可在同一水平或不同水平，比如在横截面上，一个左侧导丝管99与内管侧开口516d、516p成大约60度(45-75度)转角，另一个右侧导丝管99与内管侧开口516d、516p成大约180度转角，两侧导丝管99之间成120度转角。两侧导丝管99可以只有其中的任意一个。如右侧导丝管99与内管侧开口516d、516p成120-180度转角，或如左侧导丝管99与内管侧开口516d、516p成0-60度转角。0.014”侧导丝管99加强了内管近侧开口处的强度。0.014”侧导丝管99的位置和长度保证了可使用较短(1.5m)的0.014”外径导丝作快速交换。Referring to Fig. 6a, Fig. 6b, Fig. 6c, Fig. 7, in the delivery device of the artificial heart stent valve of the present invention, a side
参见图3a，配合参见图1a、图1b，本发明的人工心脏支架瓣膜的输放装置2中设有中管88，中管88是独立的管状结构件，位于内管51外侧，可以沿内管51滑动。中管88内径略大于内管51外径，小于或等于压缩状态下的人工支架瓣膜1外径。中管远端881不到内管近侧开口516p；中管近端882接近近端控制器80。中管88内有一根中管拉线89，中管拉线89的远端891固定在中管远端881上构成固定点893，近端892从中管近端882的侧开口884出来，中管拉线89的远端固定点893和中管近端882的侧开口884在同一平面和同一边。中管拉线89受拉后，张力增大，中管88变弯，支架拉线70自然滑到弯曲的凹面517上，这有利于输放装置通过主动脉弓。中管近端882和侧开口884内各有一紧缩环，紧缩环为硅胶环状结构，放松时沿内管滑动，紧缩时固定于内管上的一定位置。中管88颜色透明或半透明，有利于术前检查排气泡。中管88还用于加强内管中近段514、515的强度。中管88可为锥形，远段较细，近段较粗，使输放装置同时获得近段推动性和中远段弯曲性。中管88可以是一编织加强管。中管88沿内管滑动，中管远端881可推压缩状态下的支架瓣膜1出外鞘管90。Referring to Fig. 3a, referring to Fig. 1a and Fig. 1b, a
参见图3b、图6a、图6b、图6c、图7，本发明的人工心脏支架瓣膜的输放装置2中的外保护机构可以有以下三种方案选择：Referring to Fig. 3b, Fig. 6a, Fig. 6b, Fig. 6c, Fig. 7, the external protection mechanism in the
1、外鞘管901.
外鞘管90为一管状结构，由高分子材料构成，外鞘管90颜色透明或半透明，有利于术前检查冲洗后有无气泡。外鞘管远段901管壁薄，内径略大于压缩下的人工支架瓣膜1的外径，其长度略大于压缩下的人工支架瓣膜1的长度。外鞘管远段901压缩，保护支架瓣膜1。外鞘管远端902有不透X线的标志903嵌在管壁内。外鞘管中段904可以是同远段901一样的管子，也可以是管壁较厚但内径和外径都小于远段901的管子，其内径大于中管的外径，长度不等，在此情况下，中段和远段之间有一中远段交界区管905。外鞘管近段906为一外径增大的管子，其内径等于或大于中管88的内径，并设有冲洗/造影开口和阀门907。外鞘管近端908有一弹性膜或管909，弹性膜909中央有一针孔910，正常情况下针孔910关闭或只有很小的直径，中管88穿过针孔910直径可以扩大，以保证中管88滑动和弹性膜909不漏血。The
2、可撕开外保护机构922. The outer protective mechanism can be torn off 92
它包括：收线锁丝93、可撕开鞘管94和鞘管收线95。可撕开外保护机构92的中央有内管51，内管的远段513有远段远侧开口516d和近侧开口516p，这两个侧开口516d、516p可以是单独供给鞘管收线95走的单独开口，也可以是与支架拉线70合用的统一开口。内管的中段和近段同前。It includes: wire locking
内管51内有至少一根收线锁丝93可以沿内管51滑动，收线锁丝93有一远端931和近端932，收线锁丝近端932可以从近端控制器80出来。There is at least one take-
内管51外是可撕开鞘管94。可撕开鞘管94是与内管51同心的圆管形结构，位于内管51、人工支架瓣膜1和中管88之外。可撕开鞘管94与内管51之间可以滑动。可撕开鞘管94可由天然或合成的纺线织成的管状布管941或管状网管942两种方案构成。管状布管941的管壁为密封的管壁，管状网管942的管壁为有网眼943的管壁，网眼管壁可以是编织纱网或钩织网，网眼直径小于1mm，网眼943形状可变形，但同边的长度不变。可撕开鞘管94的远段部分944与内管远段513在同一水平并有一轴向或纵向开口945，纵向开口945两侧鞘管上有收线眼946，为密封管壁的开口或网眼管壁中的某个眼943，开口的两边的网管上网眼943周边密封完整。远段944的直径或周长可一致。远段944的远端947或和近端948的直径或周长可不一致，在卷曲情况下构成远端椎形947’和近端椎形948’。可撕开鞘管94的远端947直径较小，构成弹头流线型。纵向开口945贯穿远端947。可撕开鞘管94中近段部分949为一完整的管或管网，其直径或周长小于或等于远段944直径或周长。在内管远段513与可撕开鞘管远段944之间可夹有支架瓣膜1。在图6a、图6b、图6c中支架瓣膜1没有显示。支架瓣膜1与内管51结合方式同前。Outside the
可撕开鞘管远段944有纵向开口945，纵向开口边上有收线眼946。在鞘管收线95帮助下，可撕开鞘管远段944的纵向开口945可以临时性收紧，其内的支架瓣膜1纵向压缩。可撕开鞘管远段944在纵向开口945的远侧和近侧与内管51临时性相连，此时可撕开鞘管94与内管51间不能滑动，支架瓣膜1在纵向被限制在这二者之间。鞘管收线95有一远端收线环951穿过内管远侧开口或近侧开口516d、516p中的一个，被收线锁丝93卡住。这一鞘管收线95可穿过支架瓣膜1或在支架瓣膜外侧(远或近侧)。鞘管收线95成双，同时穿过可撕开鞘管远段944纵向开口945两侧的收线眼946，在第一边构成两个方向相反的单线线拐952，在第二边构成一个双线线拐953，单线线拐952与双线线拐953之间构成与鞘管纵轴垂直的双线垂直段954。鞘管收线95成双从双线线拐953继续沿纵轴走则构成双线平行段955，到相邻的收线眼946处构成一个收线半环956。中间过程如图6a、图6b、图6c所示。鞘管收线95的另一头从单线线拐952继续向近侧或远侧走构成单线平行段957，在下一个收线眼946处成双依次穿过纵向开口945两侧的收线眼946和前述的收线半环956到另一个相邻的收线眼946处构成另一个收线半环956。收线半环956被双线95后继的双线线拐953卡住。以此重复：单线线拐952一双线垂直段954一双线线拐953一双线平行段955一收线半环956一单线平行段957。双线垂直段954的长短代表鞘管收线95松紧或支架瓣膜1的径向压缩水平。最后一个收线半环956e进入内管51另一个侧开口516p、516d被同一或另一个收线锁丝93卡住。这一收线半环956e可穿过支架瓣膜1，也可不穿过支架瓣膜而在其外近侧。鞘管收线95为柔软的细线，任何双线线拐953和收线半环956都可以变形，变直，鞘管收线95各段之间的位置可以变动。鞘管收线中近段958可以经过可撕开鞘管中近段949内侧或外侧通向释放机构近侧511。鞘管收线近端959临时固定在近端控制器80上。在可撕开鞘管远段944纵向开口945两边之间，和在收线95两个相邻的双线垂直段954之间，构成一个内外相通的鞘管临时小开口945s，纵向开口945可分成多个鞘管临时小开口945s。可撕开鞘管94纵向开口945收紧情况下，一个或者一个以上侧向导丝管99或导丝，如0.014″导丝管，可以从内管51起，从内到外，穿过支架瓣膜1上没有封膜的部分，穿过鞘管临时小开口945s或纵向开口945出来，进入动脉侧支开口，如冠状动脉开口。如果只有一个纵向开口945，在同一截面上侧向导丝管99或导丝只能向一个方向开口出来。The
可撕开外保护机构92的工作原理如下：The operating principle of the tearable
a、如果向外拉收线锁丝近端932，收线锁丝93向近端滑动，收线锁丝远端931滑出远端收线环951或最后一个收线半环956e，鞘管收线95不被收线锁丝93卡住而获得释放。a. If the proximal end 932 of the take-up lock wire is pulled outward, the take-
b、拉动收线近端959，双线953、954、955、956可退出先被卡住后被释放的双线环956，按相反的顺序解除可撕开鞘管94的纵向开口945的两侧联结，可撕开鞘管94成为真正的纵向开口945，鞘管收线95可被全部收到输放装置近端。b, pulling the proximal end 959 of the take-up line, the
3、可绕结并可解结的压线机构963. The crimping
它包括：压线锁丝97和支架压线98，二者组成可绕结并可解结的压线机构96。处于可绕结并可解结的压线机构96内的内管51结构同前所述。单孔内管51可有一个大圆形通用孔腔52；双孔内管51可有两个管腔，一个0.035”导丝腔53供0.035”导丝通过，和一个大半月形通用管腔54供压线锁丝97和支架压线98通过。多孔内管51可有多个管腔，一个0.035”导丝腔53供0.035”导丝通过，和多个管腔54’供压线锁丝97和支架压线98分别在各自的管腔通过。内管远段513有至少两个开口，远侧开口516d和近侧开口516p。两个开口或与单孔内管的内管腔52相通，或与双孔内管的通用管腔54相通，或与多孔内管的支架压线管腔54’和压线锁丝管腔54’同时相通。两个开口之间的距离约等于支架瓣膜压缩下的长度，这两个侧开口516d、516p可以是单独供给支架压线98走的单独开口，也可以是与支架拉线70合用的统一开口。It comprises: wire crimping
在单孔内管的内管腔52内，或双孔内管的普通管腔54内，或多孔内管的压线锁丝管腔54’内，有一个或一个以上的压线锁丝97，从远端512到近端511贯穿。压线锁丝97有一远端971和近端972，近端972可以从近端控制器80的一个支管出来。压线锁丝97可以沿内管腔52，或沿普通管腔54，或沿压线锁丝管腔54’滑动。在同一水平或截面上可有两个侧导丝管99引导0.014″导丝从支架瓣膜1中部和支架压线98各段之间出来。In the
内管远段513外有同心套住的要被输送的支架瓣膜1，支架瓣膜1不包括在输放装置2中，但支架瓣膜1在释放前位于压线机构96结构中。支架瓣膜1可被前述的支架拉线70临时固定到内管51的同一侧开口或另外的侧开口516d、516c、516p上。The
支架瓣膜1可以被支架压线98临时性径向压缩。支架压线98为一个柔软可变形的细线，位于支架瓣膜1外侧。支架压线98的一端有远端线环981，远端线环981穿过内管远侧开口或近侧开口516d、516p中的一个，进入或内管腔52或普通管腔54或支架压线管腔54’，被一压线锁丝97卡住。在进入内管远或近侧开口516d、516p前，远端线环981可选择性在支架瓣膜1外面经过，或穿过支架瓣膜1上没有密封膜的部分。支架压线98在支架瓣膜1外表面延伸，构成一个单线线拐982。支架压线98成双线98a、98a’继续前进，绕支架瓣膜1约360度，双线穿过前述单线线拐982构成第一个双线线拐983a，继续前进构成第一个压线半环984a，支架压线98下一段继续成双线98b、98b’沿前述相反的方向绕支架瓣膜1约180度，穿过前述的第一个压线半环984a构成第二个双线线拐983b，继续前进构成第二个压线半环984b。以此方式重复，双支架压线98在支架瓣膜1外表面先向一方向绕圈，然后向另一相反的方向绕圈，构成其他两个方向相反的双线线拐983c、983d和其它两个压线半环984c、984d，后一个双线线拐983d穿过前一个压线半环984e。这样一个双线单位可以重复无数次。支架压线98为柔软的细线，任何双线线拐983和压线半环984都可以变形，变直，它们之间的位置可以变动。支架压线98在穿梭过程中可双线，在任何一个双线线拐983a、983b、983c、983d...983x和压线半环984a、984b、984c、984d...984x之间，同时穿过支架瓣膜1没有覆盖膜的部分，从外到内，然后再从内到外，将支架压线98与支架瓣膜1临时固定在一起。最后一个压线半环984z，在穿过前一个压线半环984x构成最后一个双线线拐983z后，穿过另外一端内管侧开口516p、516d，进入或内管腔52或普通管腔54或支架压线管腔54’，被同一或另一个压线锁丝97卡住。在进入内管侧开口516p、516d前，这一个最后的压线半环984z可选择性地在支架瓣膜1外穿过，或穿过支架瓣膜1没有密封膜的部份，在远端线环981和最后一个压线半环984z被同一或不同的压线锁丝97穿过卡住后，拉支架压线近端985可以收紧压线98并径向压缩其下面的支架瓣膜1。在远端线环981和最后一个压线半环984z被同一或不同的压线锁丝97穿过卡住后，支架压线98还可选择性地以同样的方式第二次绕结支架瓣膜1，第二次绕结支架瓣膜1的支架压线98为同一压线的延续，第二次绕结的支架压线98段在第一次绕结支架压线98段的外面。第二次绕结的支架压线98段的走向与第一次绕结支架压线98段的总体走向相反，并回到起始的远端线环981附近。第二次绕结的支架压线98段的最后一个压线半环984z可进入与远端线环981同一内管侧开口或不同的内管侧开口516p，并被另一个压线锁丝97所穿过卡住。支架压线中近段986可选择性地走在内管51与中管88之间，或走在内管51腔内。压线近端985可与近端控制器80临时性相连。内管中近段514、515外侧可有以同心圆方式套住的中管88。中管88内径大于内管51外径，使中管88可以沿内管51滑动。中管88与内管51之间可走有支架压线98。The stent-
可绕结并可解结的压线机构96的工作原理如下：The working principle of the
a、支架压线98拉紧并被压线锁丝97卡住后，收紧支架压线98使其下面的自扩张型支架瓣膜1径向压缩，直径变小，呈压缩状态或输送状态；a. After the
b、在前述压缩状态下，一个或多个侧向导丝管远端991或侧向导丝可从内到外穿过支架瓣膜1的中下游段15、13没有密封膜的可变形单元101，在支架压线98之间到达支架瓣膜1外侧，进入侧枝血管的入口，如冠状动脉开口。一个或多个侧向导丝进入侧枝血管后，可决定输放装置2及支架瓣膜1的旋转定位。由于压线98所占面积小，侧导丝管远端991可在不同平面和不同旋转角度引出多个不同的侧向导丝。侧导丝管远端991进入支架压线98各段之间的开放区987，使侧导丝管远端991及所连的侧向导丝即使在支架压线98绕结解除的情况下，支架压线98向近端回收时，侧向导丝与支架压线98之间不会互相卡住。b. In the aforementioned compressed state, one or more lateral guide wire tube distal ends 991 or lateral guide wires can pass through the
C、一个或多个压线锁丝97被依次向近端移动，压线锁丝远端971滑出最后一个压线半环984z和远端线环981，支架压线98被释放。向近端511拉动压线近端985可以解除支架瓣膜1外双线线拐983a、983b、983c、983d...983x与压线半环984a、984b、984c、984d...984x间的压线绕结，并将支架压线98全部回收到近端511。侧向导丝位于支架压线98间的开放区987，不受移动的支架压线98影响。C. One or more crimping
本发明的人工心脏支架瓣膜的输放装置的使用过程、工作原理和功能可综合说明如下：The use process, working principle and function of the delivery device of the artificial heart stent valve of the present invention can be comprehensively described as follows:
1、装配1. Assembly
人工支架瓣膜与输放装置2的装配包括：内管拉线70和临时回收线72的准备；术前拉线70穿支架瓣膜，装配时旋转预调整；术前拉线70在临时回收线72帮助下回到近端控制器80。为将这一过程减化到最低程度，有两种可选择的方案：The assembly of the artificial stent valve and the
a、如图5c、图5d所示，内管51内锁丝75已经到位。内管每一侧开口516d、516c、516p上拉线70已被锁丝75锁住。但拉线外段703在内管外。内管51内还有拉线近段临时回收线72，其回收环721在侧开口516d、516c、516p外，回收线72在内管内，临时回收线近端722延伸至近端控制器80从其特定拉线支管81伸出。拉线70穿过支架上一定的开放式线拐102或密封式线眼103后，穿过临时回收线72的回收环721，拉临时回收线近端722，由临时回收线72将拉线近端708回收拉到近端控制器80的特定拉线支管81外，实现内管内临时回收线72换拉线70。a. As shown in Figure 5c and Figure 5d, the
b、与a相同，但拉线70穿过支架上的开放式线拐102或密封式线眼103后与临时回收线72打结连成一长拉线70。内管远段513的每个侧开口516d、516c、516p在同一参照面RP上。支架瓣膜在拉线70和锁定丝75的帮助下，被固定和径向压紧到内管51上。拉线70穿出，穿进支架瓣膜周长上那个可变形单元，支架瓣膜与内管远段的侧开口516d、516c、516p或参照面RP的旋转角度关系就可以确定，并以半个到一个可变形单元周长单位级向预先体外装配时调整确定旋转角度。每个输放装置2可以有下列组合将拉线70在支架瓣膜的远端、中部和近端临时固定到输放装置2的内管51上：1、单拉线70和单锁丝75；2、多拉线70和单锁丝75；3、两套或以上独立单锁丝75和相应的拉线70。b. The same as a, but the
2、径向压缩2. Radial compression
人工支架瓣膜的径向压缩包括：支架瓣膜压缩，拉线70拉紧后支架瓣膜径向压缩；进一个外保护机构90或92或96，径向压缩状态下支架瓣膜进入外鞘管90或可撕开的外保护机构92或可绕结并可解结的压线机构96。The radial compression of the artificial stent valve includes: the compression of the stent valve, the radial compression of the stent valve after the
3、进入3. Enter
人工支架瓣膜与输放装置2的进入包括：The entry of artificial stent valve and
3.1、插入前准备：插入一个0.035″导丝进入左心室；在使用可撕开外保护机构92或可绕结并可解结的压线机构96情况下，必要时可插入一个或两个0.014″导丝进入左或右冠状动脉。3.1. Preparation before insertion: insert a 0.035″ guide wire into the left ventricle; if necessary, insert one or two 0.014″ guide wires when using the tearable
3.2、相应导丝进入相应导丝管61、99。3.2. Corresponding guide wires enter corresponding
3.3、输放装置2沿导丝进入血管，外鞘管90或可撕开外保护管机构92或可绕结并可解结的压线机构96保护下的支架瓣膜进入血管。3.3. The
3.4、进入主动脉弓前，外鞘管90停止前进，压缩支架瓣膜与内管51及中管出外鞘管90继续前进。3.4. Before entering the aortic arch, the
3.5、内管和中管间滑动。3.5. Sliding between the inner tube and the middle tube.
3.6、压缩支架瓣膜在无外鞘管90情况下过主动脉弓。3.6. The compressed stent valve passes through the aortic arch without the
3.7、拉线70拉紧后，内管51内拉线70受拉、变短，而内管本身不能轴向压缩。输放装置2内管远段513和中游段514因为较细较软，这样就使直内管变弯，而使已预制为弓弧形的内管中游段514弯曲度加大，则呈弓形，特别是内管中游段514已在主动脉弓内。内管远段513有压缩下支架瓣膜加固，而仍呈直线。输放装置近段515因为有较粗较硬的中管加固，而仍呈直线。3.7. After the
3.8、同时受拉的拉线70和锁丝75自然滑到内管凹面边517，而直导丝和导丝管自然滑到内管凸面边518。3.8. The
4、人工支架瓣膜的定位4. Positioning of artificial stent valve
输放装置2呈弓形的内管中游段514构成了和主动脉弓平面一致或相关的基准面RP，以致和两个冠状动脉开口有了固定的空间旋转参照面，输放装置2的侧导丝管99有助于轴向上下游和旋转角度位置定位。The arch-shaped inner
5、扩张但不释放5. Expand but not release
人工支架瓣膜的无释放性扩张，放松拉线70但锁丝75不滑动，人工支架瓣膜径向扩张，但不释放。For non-release expansion of the artificial stent valve, the
6、扩张后再压缩的可能6. Possibility of compression after expansion
拉紧拉线70，人工支架瓣膜径向再压缩。The
7、释放扩张7. Release expansion
锁定丝75向近端滑动，相关拉线环701解锁，人工支架瓣膜的释放扩张，包括：一次释放，径向扩张；分节次释放，径向扩张；先远端上游端，然后中游段，后近端下游端释放扩张；或，先中游段外层环状结构155或外层游离舌156释放扩张，定位后，然后远近端释放扩张。释放扩张中位置调整。The
8、径向扩张后，近端释放前，再压缩回外鞘管90的可能8. After radial expansion, before the proximal end is released, it is possible to compress back to the
人工支架瓣膜分节次释放扩张，在近端释放扩张前呈锥形。人工支架瓣膜可以再压缩回外鞘管90。The prosthetic stent valve is released and expanded in segments, and is tapered before the proximal end is released and expanded. The prosthetic stent-valve can be recompressed back into the
9、固定9. Fixed
将人工支架瓣膜固定在特定位置。A prosthetic stent-valve is held in place.
综上所述，本发明的人工心脏支架瓣膜的输放装置具有以下的特点和优点：In summary, the delivery device of the artificial heart stent valve of the present invention has the following characteristics and advantages:
1、可使支架瓣膜旋转定位1. The stent valve can be rotated and positioned
内管远段侧开口516d、516c、516p均在同一旋转角度上。拉线70拉紧后，内管中游段514在拉线70拉力作用下变弯，内管远段侧开口516d、516c、516p自然到了弯内管的凹面517，拉线70和锁丝75自然滑到弯管的凹侧517，0.035”导丝管61或导丝腔53在直导丝作用下自动滑到弯管凸侧518，呈偏心布置。特别是通过主动脉弓时，这样内管中段514在拉线拉紧后变弯，确定了与主动脉弓一致的基准面RP。这个基准面或内管远段侧开口516d、516c、516p与两个冠脉开口CA有固定的旋转关系。支架瓣膜可以固定到内管远段侧开口516d、516c、516p上，二者之间的旋转关系可以半个可变形单元101预先体外旋转调整。The
2、设有锁定丝75，输放装置2的锁定丝75使支架瓣膜可在两次心跳之间快速无阻力释放。一个锁定丝75可以从远到近按序释放。二个或以上锁定丝75可以选择性释放。2. A
3、可设有可撕开外保护机构92，可撕开外保护机构92中的可撕开鞘管94和鞘管收线95软而薄，可代替较硬的外鞘管90。鞘管收线95可穿过支架瓣膜。在支架瓣膜中部同一横截面上，可以经侧导丝管99走一根侧向导丝。3. A tearable
4、可设有可绕结并可解结的压线机构964. It can be equipped with a crimping
可绕结并可解结的压线机构96弯曲性好，可代替较硬的外鞘管90。支架压线98可穿过支架瓣膜，支架压线98可以收紧径向压缩支架瓣膜，在支架瓣膜中部同一横截面上，可以经侧导丝管99走一根或多根侧向导丝。The crimping
5、设有B超探头87，内管远段513上可以选择性的有一个或一个以上的B超探头87。5. A B-
6、设有中管88与中管拉线89，中管拉线89受拉后，张力增大，中管88变弯，有利于输放装置通过主动脉弓。中管88沿内管滑动，中管远端881可推压缩状态下的支架瓣膜出外鞘管90。6. A
7、设有拉线近段临时回收线72，术前临时回收线72可帮助拉线70回到近端控制器80。7. There is a
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| CN200510110146ACN100594045C (en) | 2005-11-09 | 2005-11-09 | Delivery device for artificial heart stent valve |
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| CN200510110146ACN100594045C (en) | 2005-11-09 | 2005-11-09 | Delivery device for artificial heart stent valve |
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Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8852270B2 (en) | 2007-11-15 | 2014-10-07 | Cardiosolutions, Inc. | Implant delivery system and method |
| DE102008012113A1 (en)* | 2008-03-02 | 2009-09-03 | Transcatheter Technologies Gmbh | Implant e.g. heart-valve-carrying stent, for e.g. arresting blood vessel, has fiber by which section of implant is reducible according to increasing of implant at extended diameter by unfolding or expansion of diameter with expansion unit |
| US9232998B2 (en)* | 2013-03-15 | 2016-01-12 | Cardiosolutions Inc. | Trans-apical implant systems, implants and methods |
| WO2014201452A1 (en) | 2013-06-14 | 2014-12-18 | Cardiosolutions, Inc. | Mitral valve spacer and system and method for implanting the same |
| CN105997304B (en)* | 2016-04-29 | 2017-11-28 | 肖书娜 | Heart valve annulus compression apparatus |
| US11324495B2 (en)* | 2016-07-29 | 2022-05-10 | Cephea Valve Technologies, Inc. | Systems and methods for delivering an intravascular device to the mitral annulus |
| US10661052B2 (en) | 2016-07-29 | 2020-05-26 | Cephea Valve Technologies, Inc. | Intravascular device delivery sheath |
| US10974027B2 (en) | 2016-07-29 | 2021-04-13 | Cephea Valve Technologies, Inc. | Combination steerable catheter and systems |
| US10646689B2 (en) | 2016-07-29 | 2020-05-12 | Cephea Valve Technologies, Inc. | Mechanical interlock for catheters |
| US11109967B2 (en) | 2016-08-29 | 2021-09-07 | Cephea Valve Technologies, Inc. | Systems and methods for loading and deploying an intravascular device |
| US10933216B2 (en) | 2016-08-29 | 2021-03-02 | Cephea Valve Technologies, Inc. | Multilumen catheter |
| US11045315B2 (en) | 2016-08-29 | 2021-06-29 | Cephea Valve Technologies, Inc. | Methods of steering and delivery of intravascular devices |
| US10874512B2 (en) | 2016-10-05 | 2020-12-29 | Cephea Valve Technologies, Inc. | System and methods for delivering and deploying an artificial heart valve within the mitral annulus |
| CN110384520A (en)* | 2018-04-18 | 2019-10-29 | 深圳开立生物医疗科技股份有限公司 | Ultrasonic imaging system and its conduit |
| CN109173021A (en)* | 2018-10-10 | 2019-01-11 | 郑州大学第附属医院 | A kind of the calcification score conduit and its manufacturing method of holding power reinforcement |
| US11724068B2 (en) | 2018-11-16 | 2023-08-15 | Cephea Valve Technologies, Inc. | Intravascular delivery system |
| CN111374796B (en)* | 2018-12-27 | 2025-08-29 | 上海微创心通医疗科技有限公司 | Artificial valve delivery catheter and delivery device |
| CN111374797B (en)* | 2018-12-27 | 2025-04-29 | 上海微创心通医疗科技有限公司 | A delivery catheter and delivery device for artificial valve |
| CN114617686B (en)* | 2020-12-11 | 2025-08-01 | 上海微创心通医疗科技有限公司 | Stent delivery system assembly and prosthetic valve delivery system assembly |
| CN118403272B (en)* | 2024-07-01 | 2024-10-22 | 鼎科医疗技术（苏州）有限公司 | Pressure-resistant balloon, preparation method and balloon dilation catheter |
| CN119327008B (en)* | 2024-09-11 | 2025-05-27 | 彭涛 | Adjustable radiography catheter |
- 2005
- 2005-11-09CNCN200510110146Apatent/CN100594045C/enactiveActive
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