WO2023088377A1 - 一种分体式可精准锚定的介入三尖瓣系统 - Google Patents

一种分体式可精准锚定的介入三尖瓣系统 Download PDF

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Publication number
WO2023088377A1
WO2023088377A1 PCT/CN2022/132606 CN2022132606W WO2023088377A1 WO 2023088377 A1 WO2023088377 A1 WO 2023088377A1 CN 2022132606 W CN2022132606 W CN 2022132606W WO 2023088377 A1 WO2023088377 A1 WO 2023088377A1
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Prior art keywords
tricuspid valve
anchoring
interventional
stent
split
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PCT/CN2022/132606
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English (en)
French (fr)
Inventor
金磊
黄焕雷
汪珍忠
李丽艳
范志豪
慕宏
吴嘉
吴康健
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Beijing Balance Medical Technology Co Ltd
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Beijing Balance Medical Technology Co Ltd
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Priority to US18/710,521 priority Critical patent/US12427021B2/en
Priority to CA3238581A priority patent/CA3238581A1/en
Priority to JP2024529230A priority patent/JP2024541396A/ja
Priority to EP22894908.7A priority patent/EP4434493A4/en
Priority to AU2022392685A priority patent/AU2022392685B2/en
Publication of WO2023088377A1 publication Critical patent/WO2023088377A1/zh
Anticipated expiration legal-status Critical
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    • 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
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Definitions

  • the tricuspid valve is the first one-way valve for the blood to return to the heart.
  • Valve insufficiency is mostly caused by regurgitation (TR), which is mainly caused by secondary lesions. If the disease continues to aggravate and cannot be treated in time, a large amount of reflux will lead to heart failure or even death.
  • TR regurgitation
  • the research and treatment of the tricuspid and pulmonary valves of the right heart have been neglected in the past, and their harm has been underestimated.
  • the number of cases of surgical tricuspid valve repair and replacement has been increasing year by year. For elderly patients with multiple underlying diseases, surgical valve replacement is not only risky but also often fails to obtain satisfactory therapeutic effects.
  • transcatheter tricuspid valve replacement is considered as the etiological treatment for these patients.
  • the tricuspid valve is an intracavitary valve of the right heart, it has a larger non-planar oval and softer valve ring tissue than the mitral valve, mainly due to functional regurgitation and most valve rings without calcification.
  • the present invention provides a split-type interventional tricuspid valve system that can be precisely anchored.
  • Split type means that the product is composed of two independent devices: the interventional tricuspid valve anchoring stent and the interventional bioprosthetic tricuspid valve.
  • the valve position is assisted and deformed by the external force of the ball expansion, and is integrated at the diseased valve position, so as to realize personalized and precise anchoring mainly relying on the diseased valve tissue.
  • the first anchoring state is based on the customized design of the real structure and shape of the tricuspid valve after three-dimensional reconstruction based on the individualized image data of the patient, and the customization of the three-dimensional shaping process in vitro.
  • the tissue above and below the valve is precisely matched and aligned.
  • the intervening tricuspid valve anchoring stent is funnel-shaped from the atrial surface to the ventricular surface, and the shape after release can accurately align the patient's dynamic diseased tricuspid valve supra and subvalvular tissue, and form a mutual clamp with it.
  • the processing and shaping of the first anchoring state of the intervening tricuspid valve anchoring stent depends on how to achieve the degree of precise matching between the intervening tricuspid valve anchoring stent and the real anatomical structure of the patient's tricuspid valve.
  • the real structure of the three-dimensional reconstruction is a digital image model or a 3D printed simulation solid model, and the real structure of the three-dimensional reconstruction is the three-dimensional dynamic image of the virtual simulation after the digital conversion of the comprehensive image of CT, ultrasound and nuclear magnetic field and the corresponding 3D printing simulation. realistic model of .
  • the first anchoring state of the interventional tricuspid valve anchoring stent refers to a personalized three-dimensional structure that is completely released from the catheter and separated from the catheter.
  • the second anchoring state of the intervening tricuspid valve anchoring stent refers to that in the first anchoring state, the intervening artificial tricuspid valve is sent into the intervening tricuspid valve anchoring stent in the first state by the catheter, and The second deformation of the intervening tricuspid valve anchoring stent due to the external force of capsule expansion accompanied by the expansion of the intervening tricuspid valve, from the original conical (funnel-shaped) shape in the first anchoring state to the final cylindrical shape, And combined with the expanded interventional bioprosthetic tricuspid valve, at the same time, the ventricular surface structure of the interventional tricuspid valve anchoring stent in the second anchoring state and the chordae and papillary muscles of the patient's tricuspid valve finally achieve precise Anchored by the combination of presets.
  • the fixing strut maintains an angle consistent with the connecting portion of the anchoring stent; in the second anchoring state of the tricuspid valve anchoring stent, the A plurality of fixed struts are encircled centripetally and are axially parallel, so that the ends of the fixed struts are embedded in the bracket at the inflow end of the intervening tricuspid valve, and the intervening tricuspid valve is fixed to ensure zero displacement of the valve release.
  • the number of said fixed poles is 3-12, preferably 9.
  • Figure 1 is the physical picture of EVOQUE interventional tricuspid valve.
  • Fig. 6 is a schematic diagram of the ventricle surface and the stent connection part of the split-type anchoring stent according to an embodiment of the present invention.
  • 7A-C are schematic diagrams of fixed struts and centripetal bending of a split-type anchoring stent according to an embodiment of the present invention.
  • 15A-B are schematic diagrams showing the process of delivering an anchoring stent through the transfemoral vein through the interatrial septum to intervene the tricuspid valve according to an embodiment of the present invention.
  • a split-type interventional tricuspid valve system that can be accurately anchored, the system includes a split interventional tricuspid valve anchoring bracket 10 and an interventional artificial biological tricuspid valve 20, the interventional tricuspid valve anchoring
  • the shape and structure of the stent match the anatomical structure of the real lesion of the tricuspid valve after the three-dimensional reconstruction of the patient's image data. , and the tissues of the patient's tricuspid valve on the valve 40 and below the valve 50; the interventional artificial biological tricuspid valve is transported into the interventional tricuspid valve anchoring stent that has been engaged with the tissue.
  • FIG. 3A-C is a schematic diagram of the combination of three split-type anchoring stents with different supravalvular and subvalvular structures and the interventional bioprosthetic tricuspid valve, but the general structure and composition are based on the same design ideas and concepts.
  • the schematic diagrams of the split-type anchoring stents with different supravalvular and subvalvular structures have the same overall structure, but due to the matching of different patient tissues, atrial surfaces with different curvatures will be designed.
  • Positioning hooks loop 121, and the quantity, angle, length, etc. of the anchoring hook loop 122 are all based on the preoperative CT scan of the individual patient.
  • the first mesh portion and the second mesh portion of the intervening tricuspid valve anchoring stent are formed by unit meshes composed of compressible diamond meshes, V-shaped meshes and/or hexagonal or polygonal meshes, The first mesh portion is adaptively connected to the second mesh portion.
  • the outer periphery of the grid portion of the atrial surface of the intervening tricuspid valve anchoring stent is spaced 1-2mm from the patient's atrium wall, preferably 1.5mm.
  • the diameter of the inner peripheral edge of the second grid portion of the intervening tricuspid valve anchoring stent matches the outer diameters of various sizes and specifications of the intervening artificial biological tricuspid valve.
  • the core point of the present invention lies in: 1 split anchoring stent design and intervening tricuspid valve anterior and posterior transcatheter delivery and combination in the heart; Data, personalized design of the anchoring stent structure and three-dimensional shaping; 3Using the junction of the valve leaflets, through the specially designed positioning hook loop, accurately locate the similarity of the atrial surface shape of the anchoring stent and the subvalvular hook loop structure and the tricuspid valve.
  • the surface anchoring hook-loop structure is further closely combined with the subvalvular tissue to complete the pre-designed alignment anchoring, and at the same time form a clamp with the structure on the valve to achieve final anchoring; 4 Intervene at the inflow end of the tricuspid valve anchoring stent connection
  • the strut structure set at the outflow end can be integrated with the interventional tricuspid valve from both ends to ensure that the valve does not shift; Precise and precise interventional tricuspid valve treatment process, the analysis of relevant data, the shape design, processing and manufacturing of the interventional tricuspid valve anchoring stent, relevant data obtained during the whole process of interventional treatment, and postoperative follow-up data, etc., as a An independent data unit, accumulating a large amount of personalized image data, anchoring stent design and manufacturing parameters, interventional treatment process and postoperative results and other related data, gradually realizing the split-type precise anchoring interventional tricuspid valve system interventional treatment Implementation of intelligence, commercialization and scale.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (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)
  • Mechanical Engineering (AREA)
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Abstract

一种分体式可精准锚定的介入三尖瓣系统，包括分体的介入三尖瓣锚定支架（10）和介入人工生物三尖瓣（20），介入三尖瓣锚定支架（10）的形态和结构与患者影像数据经三维重建后的三尖瓣真实结构相匹配，介入三尖瓣锚定支架（10）先被输送至患者三尖瓣位释放、形变、与患者三尖瓣位瓣上（40）和瓣下（50）的组织个性化精准对位接合；介入人工生物三尖瓣（20）被输送至介入三尖瓣锚定支架（10）内释放，介入人工生物三尖瓣（20）被释放形变扩启至功能状态，使介入三尖瓣锚定支架（10）再次形变与扩启的介入三尖瓣（20）结合，同时介入三尖瓣锚定支架（10）的再次形变致锚定支架（10）与瓣下（50）组织完成事先预设的结合而锚定。分体式可精准锚定的介入三尖瓣系统基于三维重建而设计的系统，可以实现介入三尖瓣个性化的精准锚定。

Description

一种分体式可精准锚定的介入三尖瓣系统 技术领域
本发明涉及一种人工生物心脏瓣膜，特别涉及一种分体式可精准锚定的介入三尖瓣系统。
背景技术
三尖瓣作为血液回流心脏的首个入口的单向阀门，发生瓣膜功能不全多为返流(TR)，主要以继发病变为主，常见因同时伴有其它瓣位的瓣膜病变所致，病情持续加重时如不能得到及时治疗，出现大量返流将导致心功能衰竭甚至死亡。与左心二尖瓣和主动脉瓣相比，右心三尖瓣和肺动脉瓣的研究和救治过去一直被忽视，其危害被低估。近年来外科三尖瓣修复和置换的病例数在逐年增加。对于老龄且合并多种基础疾病的患者，手术换瓣不仅风险高而且也常常不能获得满意的治疗效果。由于国内有大量不得不需要救治的TR患者，随着介入主动脉瓣(TAVR)在高龄或传统外科主动脉瓣置换高危患者的有效治疗，近十年，对经导管三尖瓣的修复与置换器械的研究取得诸多进展。其中，经导管三尖瓣置换被认为是针对这类患者的病因治疗。但由于三尖瓣作为右心的腔内瓣膜，其对比二尖瓣具有更大的非平面椭圆形且质地更加柔软的瓣环组织、主要为功能性关闭不全多数瓣环无钙化、对比左心更薄的右心室壁、紧邻瓣环处右冠状动脉、紧邻传导束等较为复杂瓣周环境，以及随每次心动周期瓣环和瓣上瓣下的大幅度的形变，这些解剖形态与结构的多样性和复杂性使介入人工生物三尖瓣难以延用像介入主动脉瓣那样靠瓣上形状和瓣周径向支撑来设计介入三尖瓣。现有介入三尖瓣产品以及已有同类产品公开的专利，从设计理念与结构特征上，均为一次性经导管植入和一体的瓣膜结构(图1-2)，难以满足三尖瓣位个性化的复杂病理解剖环境。
发明内容
与以往的介入三尖瓣产品设计的理念不同，本发明提供了一种分体式可精准锚定的介入三尖瓣系统。分体式的含义是指产品由介入三尖瓣锚定支架和介入人工生物三尖瓣两个独立的器械构成，前者先经由导管输送至三尖瓣位释放，随即后者导入与前者在三尖瓣位通过球扩外力的辅助和形变，在病变瓣位处结合为一体，从而实现主要依靠病变瓣膜组织的个性化的精准锚定。
与以往的介入三尖瓣产品的结构不同，本发明介入三尖瓣系统是由介入三尖瓣锚定支架与介入三尖瓣瓣膜两部分共同构成，瓣膜的锚定与瓣膜的瓣叶的支撑分为两个不同的结构，即分体的介入三尖瓣锚定支架负责瓣膜的锚定，介入人工生物三尖瓣类似介入瓣中瓣一样被输送至事先介入的锚定瓣架内释放并与支架结合实现精准锚定。
本发明介入三尖瓣系统包括分体的介入三尖瓣锚定支架和分体式可精准锚定的人工生物三尖瓣假体两个部分构成。所述发明的主要内容之一是所述介入三尖瓣锚定支架的形状和结构具有两种不同的锚定状态，即经导管释放后的第一锚定状态，和与介入三尖瓣结合后的第二锚定状态。
所述第一锚定状态是依据患者个性化影像数据经三维重建后的三尖瓣真实结构与形态定制化设计、体外三维成形加工定制，因此经所述导管释放后回形可与患者三尖瓣位瓣上和瓣下的组织精准匹配对位接合，所述介入三尖瓣锚定支架的心房面至心室面呈漏斗状，释放后的形态可精准对位患者动态的病变三尖瓣瓣上和瓣下组织，并与之形成相互夹持。所述介入三尖瓣锚定支架第一锚定状态的加工和定形，取决于如何实现介入三尖瓣锚定支架与患者三尖瓣真实解剖结构精准匹配程度。所述三维重建的真实结构为数字影像模型或3D打印的仿真实体模型，所述三维重建的真实结构是CT、超声及核磁的综合影像数字化转换后虚拟仿真的三维动态图像以及相应的3D打印仿的真实体模型。
所述介入三尖瓣锚定支架第一锚定状态，是依据三维重建的患者三尖瓣真实解剖形态设计加工成为伞管形的支架结构，即由心房面、心室面和两者之间的锚定支架连接部三个部分构成。所述①心房面为伞片状，具有与患者心房面影像数据三维重建的真实形态相匹配的伞片状，为第一网格部分，释放后可铺贴在右心房底部于三尖瓣环的上端；所述②心室面为与患者三尖瓣的前瓣、隔瓣和后瓣三瓣叶交界位置精准预设的三个定位钩袢，释放后定位锚定支架心房面与患者右心房形态个性化对应铺贴；所述③锚定支架连接部为圆口漏斗状，为第二网格部分。至此，展现的是所述介入三尖瓣锚定支架第一锚定状态是指由导管内全部释放脱离导管的个性化的三维结构。
所述介入三尖瓣锚定支架第二锚定状态是指在第一锚定状态下，介入人工生物三尖瓣被导管送入第一状态下的介入三尖瓣锚定支架内，经球囊扩启的外力伴随介入三尖瓣的扩启而发生的介入三尖瓣锚定支架的第二次形变，由原来第一锚定状态的圆锥形(漏斗状)形变为最终的圆柱形，并和被扩启的所述介入人工生物三尖瓣结合为一体，同时第二锚定状态的介入三尖瓣锚定支架的心室面结构与患者三尖瓣的腱索和乳头肌最终实现精准预设的结合而锚定。
所述介入三尖瓣锚定支架连接部第一锚定状态为经导管输送并释放后的个性化对应患者真实解剖形态与结构的三维定形记忆状态，所述连接部从心房面到心室面的定形记忆状态具有收缩锥度，所述锥度为5-45度，视患者病变瓣叶的形态而定，所述锚定支架的连接部经形变扩张由第一锚定形状态的圆锥形漏斗状变形为圆柱状的第二锚定状态。所述介入三尖瓣锚定支架的第一锚定状态下，所述定位钩袢经导管释放后，插入与之匹配的患者病变三尖瓣的前瓣、隔瓣和后瓣三瓣叶的交界位置，实现定位锚定支架心房面与患者右心房形态个性化对应铺贴。所述三尖瓣锚定支架心室面具有多个锚定钩袢，自连接部延伸至右心室面后翻折，与患者病变三尖瓣瓣下影像数据三维重建的真实腱索及瓣下组织结构形态等数精准匹配。所述锚定钩袢的数量、尺寸、形态以及翻折的角度与患者病变三尖瓣瓣下影像数据三维重建的真实的腱索间隙、三尖瓣叶的大小、形状以及瓣周组织距心室壁的圆周间隔个性化精准匹配。
所述介入三尖瓣锚定支架的第二锚定状态，主要是依据患者的三尖瓣超声影像三维重建的患者 三尖瓣瓣叶形态、瓣叶面积大小、与三瓣叶下的腱索和乳头肌的真实解剖结构，设计加工所述介入三尖瓣锚定支架心室面的定位钩袢的形态、尺寸、弯折的角度，从而使之当插入压握状态的介入人工生物三尖瓣并充压泵加压扩启时，其形态和结构匹配等数量的锚定钩袢，对位形变实现预设的最终锚定状态，完成与患者三尖瓣位及瓣下组织的最终精准紧密结合。
所述介入三尖瓣锚定支架由置于导管内的压缩状态，在经导管释放后呈现为第一锚定状态，再与介入三尖瓣结合转变为第二锚定状态，是由所述锚定支架连接部的3个定位钩袢，经导管释放后精准插入三尖瓣前瓣、隔瓣与后瓣的三个交界，从而定位整个支架，所述定位钩袢不仅定位了所述介入三尖瓣锚定支架心房面的形态和患者右心房形态以及心动周期右心房收缩舒张的幅度相适应，而且也定位了所述介入三尖瓣锚定支架心室面的数个锚定钩袢于患者病变三尖瓣瓣叶下的腱索间隙如数对应插入、夹持以及介入三尖瓣锚定支架转变为第二锚定状态下这些锚定钩袢可与瓣下组织的交织和预设的紧密结合。
所述介入三尖瓣锚定支架由经导管释放后的第一锚定状态，然后与介入三尖瓣结合形变为第二锚定状态，在所述介入三尖瓣锚定支架的连接部的心房面端部设置有用于嵌入介入三尖瓣的瓣膜支架的多个固定支杆，所述固定支杆沿心房面方向轴向延伸后其端部朝向锚定支架的轴心弯折；所述三尖瓣锚定支架的连接部设置有用于嵌入介入三尖瓣支架流出端若干端头向心折钩，这些向心折钩与所述三尖瓣锚定支架的连接部心房面端部设置用于嵌入介入三尖瓣支架心房端的多个固定支杆上下合围，可防止介入三尖瓣释放时向心室侧移位。所述介入三尖瓣锚定支架第一锚定状态下，所述固定支杆保持与锚定支架连接部一致的角度，在所述三尖瓣锚定支架第二锚定状态下，所述多个固定支杆向心合围呈轴向平行，使固定支杆端头嵌于介入三尖瓣流入端的支架上，固定介入三尖瓣确保瓣膜释放的0位移。所述固定支杆为3-12个，优选为9个。所述介入三尖瓣锚定支架第一网格部分和第二网格部分为由可压缩的菱形网格、V形网格和/或六边形或多边形网格构成的单元网格形成，所述第一网格部分与第二网格部分适应性连接。所述介入三尖瓣锚定支架心房面的网格部分的外周缘与患者心房壁间隔1-2mm，优选间隔1.5mm。所述介入三尖瓣锚定支架第二网格部分的内周缘直径与介入式人工生物三尖瓣各种相应大小规格的外径相匹配。所述介入三尖瓣锚定支架表面部分或全部被覆有一层医用高分子薄膜。所述三尖瓣锚定支架的心房面、心室面和锚定支架的连接部为激光一体切割后三维成形结构或心房面、心室面和锚定支架的连接部分体加工再连接结构。所述锚定支架为具有形状记忆可回形性能的金属材料或非金属材料。所述锚定支架为镍钛合金材质。
进一步，所述介入人工生物三尖瓣包括径向可压缩，并可被球囊扩张后呈圆柱状或不全圆柱状的钴铬合金支架，或径向可压缩自膨的镍钛合金支架，三个设置于所述支架内侧的扇形瓣叶，任一所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管或可支撑三个瓣叶交界固定的各种形态可压握的瓣膜支架。所述瓣膜支架为钴基合 金钴或铬合金或镍钛合金。所述介入人工生物三尖瓣输送套件包括介入人工生物三尖瓣输送器、导引鞘、瓣膜压握器和充压泵。所述介入三尖瓣锚定支架输送器和介入人工生物三尖瓣输送器可经股静脉由下腔静脉路入或经颈静脉或锁骨下静脉由上腔静脉输送至三尖瓣位。所述介入三尖瓣锚定支架先经导管路入患者病变三尖瓣位并释放为第一锚定状态，然后再经导管将介入人工生物三尖瓣送入锚定支架内，随着瓣膜被扩开，同时介入三尖瓣锚定支架被扩至第二锚定状态，同时支架连接部与介入三尖瓣的嵌合以及支架心室面完成与瓣下结构的进一步紧密结合形成最终锚定。
本发明中，每完成一次针对具体患者的个性化预设实现精准锚定的介入三尖瓣治疗过程，所有上述相关数据作为一个独立的数据单元，累积大量个性化的数据，通过人工智能实现所述分体式可精准锚定介入三尖瓣系统的智能化、规模化与产业化。
附图说明
图1为EVOQUE介入三尖瓣实物图。
图2为LuX-Valve介入三尖瓣实物图。
图3A-C为根据本发明实施例的瓣上瓣下结构各异的分体式锚定支架与介入人工生物三尖瓣组合示意图。
图4A-4C为根据本发明实施例的瓣上瓣下结构各异的分体式锚定支架示意图。
图5为根据本发明实施例的分体式锚定支架的心房面示意图。
图6为根据本发明实施例的分体式锚定支架的心室面和支架连接部示意图。
[根据细则91更正 12.01.2023]　
图7A-C为根据本发明实施例的分体式锚定支架的固定支杆和向心弯折示意图。
图8A-8B为根据本发明实施例的介入三尖瓣锚定支架植入人体后的第一锚定状态示意图。
[根据细则91更正 12.01.2023]　
图9A-B为根据本发明实施例的介入三尖瓣锚定支架植入人体后的第二锚定状态示意图。
图10为根据本发明实施例的介入三尖瓣锚定支架植入人体后的锚定钩袢与腱索二次锚定示意图。
图11A-11B为根据本发明实施例的压缩前后的介入人工生物三尖瓣示意图。
图12为根据本发明实施例的输送系统示意图。
图13为根据本发明实施例经股静脉路入穿房间隔介入三尖瓣锚定支架装载示意图。
图14A-D为根据本发明实施例的经股静脉路入穿房间隔介入三尖瓣锚定支架过程示意图。
图15A-B为据本发明实施例的经股静脉路入穿房间隔介入三尖瓣送入锚定支架过程示意图。
图16A-C根据本发明实施例经复合路径路入介入三尖瓣锚定支架过程示意图。
图17A-D根据本发明实施例经复合路径路入介入三尖瓣送入锚定支架过程示意图。
具体实施方式
结合附图和上述本发明的具体描述，能够更加清楚地了解本发明的细节。但是，在此描述的本发明的具体实施方式，仅用于解释本发明的目的，而不能以任何方式理解成是对本发明的限制。在 本发明的教导下，技术人员可以构想基于本发明的任意可能的变形，这些都应被视为属于本发明的范围。
根据本发明，一种分体式可精准锚定的介入三尖瓣系统，该系统包括分体的介入三尖瓣锚定支架10和介入人工生物三尖瓣20，所述介入三尖瓣锚定支架的形态和结构与患者影像数据经三维重建后的三尖瓣真实病变的解剖结构相匹配，所述介入三尖瓣锚定支架先经导管被输送至患者病变的三尖瓣位释放、形变、与患者三尖瓣位瓣上40和瓣下50的组织对位接合；所述介入人工生物三尖瓣经导管被输送至所述已与组织对位接合的介入三尖瓣锚定支架内释放，所述介入人工生物三尖瓣被释放形变扩启至功能状态，使所述介入三尖瓣锚定支架再次形变与扩启的介入三尖瓣结合，同时所述介入三尖瓣锚定支架的再次形变致锚定支架与病变的三尖瓣及瓣下组织的再次结合实现对介入人工生物三尖瓣的最终锚定。由于每位患者的真实病变不尽相同，根据患者的影像数据经三维重建而设计的介入三尖瓣锚定支架也不尽相同，会根据患者的真实情况进行调整，如图3A-C所示，为三种瓣上瓣下结构各异的分体式锚定支架和介入人工生物三尖瓣的组合示意图，但大体结构和构成都基于相同的设计思路和理念。
参阅图4-图6所示，根据本申请的介入三尖瓣锚定支架10，即定型为心房面大心室面小的漏斗状为一伞管形支架结构，包括心房面11、心室面12和两者之间的锚定支架连接部13，所述心房面为伞片状具有与患者心房面影像数据三维重建的真实形态相匹配的伞片状，即为第一网格部分；所述心室面12为与患者三尖瓣的前瓣、隔瓣和后瓣三瓣叶交界位置精准预设的三个定位钩袢121和多个与患者病变三尖瓣瓣下影像数据三维重建真实形态相匹配的锚定钩袢122；所述锚定支架连接部13为自心房面至心室面之间的上大下小的圆口漏斗状结构，其连接部的长度与对应的介入人工生物三尖瓣高度相匹配，并具有可扩张为圆柱状的第二网格部分。如图4A-5C所示，不同的瓣上瓣下结构的分体式锚定支架示意图，总体结构一致，但由于匹配不同患者的病患组织，会设计出不同弯曲度的心房面11、定位钩袢121、以及锚定钩袢122的数量、角度、长度等。也就是说，介入三尖瓣锚定支架心房面的形态以及覆盖面积的大小和支架心室面及锚定钩袢的形态、数量、长短和角度以及结构关系，都是根据患者个体的术前CT影像数据，经三维重建(3mensio)后的患者的心房(瓣上)和心室(瓣下)的真实结构以及参考三维超声图像测量得出的各径限结构与真实尺寸对应匹配，以此设计介入三尖瓣锚定支架的加工图纸，通过特定的镍钛记忆合金管材的三维激光切割和三维成形加工，最终定制成个性化的三尖瓣锚定支架。
参阅图7A-7C为了使锚定支架和介入三尖瓣的结合更为牢固，所述介入三尖瓣锚定支架的连接部的心房面11端部设置有用于嵌入介入三尖瓣支架的多个固定支杆111，所述固定支杆沿心房面方向轴向延伸后其端部朝向锚定支架的轴心弯折。或者，所述三尖瓣锚定支架的连接部设置有用于嵌入介入三尖瓣支架流出端若干端头向心折钩112，在心房面也可以类似的向心折钩替代所述的固定支杆。所述介入三尖瓣锚定支架第一锚定状态下，所述固定支杆111保持与锚定支架连接部一致 的角度，在所述三尖瓣锚定支架第二锚定状态下，所述多个固定支杆111向心合围呈轴向平行，使固定支杆端头嵌于介入三尖瓣流入端的支架上，固定介入三尖瓣以防止向心房面位移。所述固定支杆111为3-12个。
所述介入三尖瓣锚定支架第一网格部分和第二网格部分为由可压缩的菱形网格、V形网格和/或六边形或多边形网格构成的单元网格形成，所述第一网格部分与第二网格部分适应性连接。所述介入三尖瓣锚定支架心房面的网格部分的外周缘与患者心房壁间隔1-2mm，优选间隔1.5mm。所述介入三尖瓣锚定支架第二网格部分的内周缘直径与介入式人工生物三尖瓣各种相应大小规格的外径相匹配。所述介入三尖瓣锚定支架表面被覆有一层医用高分子薄膜。所述三尖瓣锚定支架的心房面、心室面和锚定支架的连接部为激光一体切割后三维成形结构或心房面、心室面和锚定支架的连接部分体加工再连接结构。所述锚定支架为具有形状记忆可回形性能的金属材料或非金属材料，比如为镍钛合金材质。
上述按患者影像真实数据加工制造三尖瓣锚定支架为支架的压握前状态，也是支架经导管输送至三尖瓣位于病变瓣口处释放后的第一锚定状态，如图8A-8B所示。介入三尖瓣锚定支架的第二锚定状态是当介入三尖瓣经导管输送至锚定支架内，通过球囊辅助扩张，瓣膜被扩启(或镍钛记忆合金瓣膜支架自膨)使三尖瓣锚定支架由第一锚定状态形变为第二锚定状态，凭借支架的形变力与介入三尖瓣释放的球扩力相结合成为一体如图9A-9B所示。同时，对位插入瓣下的腱索及瓣下组织的锚定支架心室面锚定钩袢，在介入三尖瓣球扩外力的作用下，随着锚定支架由第一锚定状态形变为第二锚定状态，心室面锚定钩袢也将进一步与腱索及瓣下组织50更加紧密结合在一起实现最终锚定，如图10所示。与此同时，锚定支架第一锚定状态下，其连接结构心房端固定支杆或支架弯折随着形变为第二锚定状态，向心合围呈轴向平行，使固定支杆端头或支架弯折与连接部心室端的支架回钩合力扣住介入三尖瓣支架两端的支杆上，这种锚定支架与介入三尖瓣支架两端的自动吻扣的结构使瓣膜与锚定支架精准结合成为一体，确保介入三尖瓣的0移位，如图7A-7B所示。
本发明的核心点在于：①分体的锚定支架设计和介入三尖瓣前、后分别经导管输送并在心内的结合；②依据患者术前病变三尖瓣瓣上和瓣下结构的影像数据，个性化设计锚定支架结构并三维定型；③利用瓣叶交界，通过专设的定位钩袢，准确定位锚定支架的心房面形态相似性铺贴和瓣下钩袢结构与三尖瓣叶腱索和乳头肌对位接合；④锚定支架释放后第一锚定状态(漏斗状)是依据患者真实的病理解剖结构，确定了最终锚定的原理和部位，即第二锚定状态(圆柱状)的预设过渡状态，对位个性化的病理解剖结构，随后借助介入三尖瓣球扩释放的形变力使锚定支架形变为锚定支架的第二锚定状态，从而使介入三尖瓣与锚定支架在心内嵌合成一体形成第二锚定状态，随即实现于瓣上瓣下的夹持，以致再次将瓣下组织扭紧于锚定支架与心室壁之间，完成最终锚定；⑤锚定支架由第一状态形变为第二状态，该形变过程实现了可与介入三尖瓣的自动结合，使介入三尖瓣的释放操控获自动精准效果。
本发明所述介入人工生物三尖瓣，因为有锚定支架结合，其结构只服务于三瓣叶的合理支撑，包括径向可压缩，并可被球囊扩张后呈圆柱状的钴铬合金支架，或径向可压缩自膨后呈圆柱状的镍钛合金支架，三片设置于所述支架内侧的扇形瓣叶，均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管或可支撑三瓣叶交界固定的各种形态可压握的瓣膜支架。瓣架为钴基合金钴或铬合金或镍钛合金。可参阅图11A-11B。
本申请的三尖瓣系统还包括输送组件30，所述输送组件包括介入三尖瓣锚定支架输送套件和介入人工生物三尖瓣输送套件，所述介入三尖瓣锚定支架输送套件包括输送导管31、介入三尖瓣锚定支架装载器32。所述介入人工生物三尖瓣输送套件包括介入人工生物三尖瓣输送器、导引鞘、瓣膜压握器和充压泵。所述介入三尖瓣锚定支架输送器和介入人工生物三尖瓣输送器可经由股静脉穿房间隔、心尖穿刺或左房穿刺路入。这些技术与现有技术类似。
在应用本申请的介入三尖瓣系统进行介入治疗时，采用经股静脉由下腔静脉路入或经颈静脉必由上腔静脉路入。
图13-图5：经股静脉由下腔静脉路入
经股静脉由下腔静脉路入是最常用也是最方便的路入方式。把装载好的锚定支架经股静脉由下腔静脉输送至右心房患者病变的三尖瓣内(图14A)，释放定位钩袢完成定位(图14B)，顺序释放锚定支架心室面(图14C)、支架连接结构和心房面，使心室面锚定钩袢对位结合，即为锚定支架的第一锚定状态(图14D)；撤出锚定支架输送器，沿原路把装载好的介入三尖瓣输送至锚定支架内(图15A)，然后通过球囊辅助扩启介入三尖瓣，使锚定支架形变为第二锚定状态，实现与介入三尖瓣自行精准结合，同时与瓣下组织形成夹持，完成最终锚定(图15B)。
本申请的介入三尖瓣系统还以通过颈静脉路入途径，参阅图167。
把装载好的锚定支架经颈静脉由上腔静脉输送至右心房患者病变的三尖瓣内，以下过程同上(图16-图17)。
以上所述实施例仅是为充分说明本发明所举的规范实施例。本发明的介入三尖瓣系统，业已经动物实验实施了以上所述的技术方案，确认是可行的。
本发明可实现的意义在于：①分体设计实现了瓣膜的瓣叶支撑与瓣膜的锚定在功能上分开，把瓣膜于三尖瓣位的锚定交给锚定支架，因此可以实现锚定的个性化设计，同时分步介入锚定支架和介入瓣膜，可避免结构复杂而压握后的体积过大，致使经导管输送困难；②通过病变瓣膜的解剖结构特征进行锚定原理及最终锚定部位的预先设计和测量，确定锚定支架的第二锚定状态；通过患者个性化影像学数据、专用软件及3D打印预试为锚定支架构建各部位的尺寸和维度完成预设的过渡状态，即第一锚定状态的三维定形设计和加工，使其经导管释放后精准对位，也为介入瓣膜的顺利送达提供支持。如锚定支架第一状态的锥形结构即可适度张开较重狭窄，又可约束较重度关闭不全 。前者不仅为瓣膜介入提供通道，也可避免狭窄病变突然扩大；后者可减轻瓣膜关闭不全的大量返流，为介入三尖瓣的进入提供空间和时间的保障；③利用瓣膜释放的外力驱动锚定支架由漏斗状的第一锚定状态形变为圆柱状的第二状态，这种形变产生锚定支架向心紧握瓣膜，实现与介入瓣膜的嵌合保证瓣膜的0移位，并借助心室面锚定钩袢结构进一步与瓣下组织紧密结合，完成事先设计的对位锚定，同时与瓣上的结构形成夹持实现最终锚定；④介入三尖瓣锚定支架连接部的流入端和流出端的设置的支杆结构可从两端合抱与介入三尖瓣结为一体，确保瓣膜无移位；⑤以上所述的分体式可精准锚定的介入三尖瓣系统，每完成一次个性化预设的精准介入三尖瓣的治疗过程，对相关数据的分析、介入三尖瓣锚定支架的形态设计、加工制造、介入治疗全过程获得的相关数据以及术后随访数据等，作为一个独立的数据单元，累积大量个性化的影像数据、锚定支架设计以及加工制造参数、介入治疗过程及术后结果等相关数据，逐步实现所述分体式可精准锚定介入三尖瓣系统介入治疗实施的智能化、商业化与规模化。

Claims (30)

  1. 一种分体式可精准锚定的介入三尖瓣系统，其特征在于，
    该系统包括分体的介入三尖瓣锚定支架和介入人工生物三尖瓣，
    所述介入三尖瓣锚定支架的形态和结构与患者影像数据经三维重建后的三尖瓣真实结构相匹配，所述介入三尖瓣锚定支架先被输送至患者三尖瓣位释放、形变、与患者三尖瓣位瓣上和瓣下的组织个性化精准对位接合；
    所述介入人工生物三尖瓣被输送至所述介入三尖瓣锚定支架内释放，所述介入人工生物三尖瓣被释放形变扩启至功能状态，使所述介入三尖瓣锚定支架再次形变与扩启的介入三尖瓣结合，同时所述介入三尖瓣锚定支架的再次形变致锚定支架与瓣下组织完成事先预设的结合而锚定。
  2. 根据权利要求1所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述三尖瓣系统还包括输送组件，所述输送组件包括介入三尖瓣锚定支架输送套件和介入人工生物三尖瓣输送套件，所述介入三尖瓣锚定支架输送套件包括输送导管、介入三尖瓣锚定支架输送器和支架装载器。
  3. 根据权利要求1或2所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述分体式介入三尖瓣锚定支架和介入人工生物三尖瓣是经前、后分别路入，然后在体内再次组装合二为一，同时致所述介入三尖瓣锚定支架再次形变与患者病变的三尖瓣及瓣下组织完成事先预设的结合，实现介入人工生物三尖瓣的锚定，以致原位替代病变的三尖瓣。
  4. 根据权利要求1或2所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架具有置于导管内的压缩状态、经导管释放后的第一锚定状态和与介入三尖瓣结合后的第二锚定状态，
    所述第一锚定状态下，所述三尖瓣锚定支架经所述导管释放后形变与患者三尖瓣位瓣上和瓣下组织个性化精准对位接合与夹持；
    所述第二锚定状态下，所述介入人工生物三尖瓣被导管送入第一状态下的介入三尖瓣锚定支架内被球扩外力扩启而二次形变，与被扩启的所述介入人工生物三尖瓣结合为一体，同时完成锚定支架与患者三尖瓣位的瓣叶或下的组织完成事先预设的结合而锚定。
  5. 根据权利要求4所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，
    所述第一锚定状态下，所述介入三尖瓣锚定支架被加工定型为心房面大、心室面小的漏斗状，所述介入三尖瓣锚定支架经导管输入并释放后的形变和回形适应患者动态的病变三尖瓣瓣上和瓣下组织个性化对位接合和夹持；
    所述第二锚定状态下，所述第一锚定状态的介入三尖瓣锚定支架与经导管输送至支架内的介入人工生物三尖瓣被球扩而结合为一体，使介入三尖瓣锚定支架由原来的漏斗状与介入的三尖瓣一起扩为 圆柱状的二次形变产生的向心回形夹持，同时完成与患者三尖瓣位及瓣下组织预设的紧密结合。
  6. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，
    所述三维重建的真实结构为数字影像模型或3D打印的仿真实体模型；所述三维重建的真实结构是CT、超声及核磁的综合影像数字化转换后虚拟仿真的三维图像以及相应的3D打印仿真实体模型。
  7. 根据权利要求1-6所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，
    所述介入三尖瓣锚定支架为一伞管形支架结构，包括心房面、心室面和两者之间的锚定支架连接部，所述心房面为伞片状，具有与患者心房面影像数据三维重建的真实个性化形态相匹配的伞片状，即为第一网格部分；所述心室面为与患者三尖瓣的前瓣、隔瓣和后瓣三瓣叶交界位置精准预设的三个定位钩袢；所述锚定支架连接部为圆口漏斗状，其具有圆口直径与患者三尖瓣瓣环内径和随后介入三尖瓣外径，漏斗的下端开口与三尖瓣瓣叶狭窄或/和关闭不全病变形态及程度相匹配的第二网格部分。
  8. 根据权利要求7所述的分体式可精准锚定的介入三尖瓣系统，其特征在于所述介入三尖瓣锚定支架连接部第一锚定状态为经导管输送并释放后的个性化对应患者真实解剖形态与结构的三维定形记忆状态，所述连接部从心房面到心室面的定形记忆状态具有收缩锥度，所述锥度为5-45度，视患者病变瓣叶的形态而定，所述锚定支架的连接部经形变扩张由第一锚定形状态的圆锥形漏斗状变形为圆柱状的第二锚定状态。
  9. 根据权利要求8所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架的第一锚定状态下，所述定位钩袢经导管释放后，插入与之匹配的患者病变三尖瓣的前瓣、隔瓣和后瓣三瓣叶的交界位置，实现定位锚定支架心房面与患者右心房形态个性化对应铺贴。
  10. 根据权利要求7所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述三尖瓣锚定支架心室面具有多个锚定钩袢，自连接部延伸至右心室面后翻折，与患者病变三尖瓣瓣下影像数据三维重建的真实腱索及瓣下组织结构形态等数精准匹配。
  11. 根据权利要求10所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述锚定钩袢的数量、尺寸、形态以及翻折的角度与患者病变三尖瓣瓣下影像数据三维重建的真实的腱索间隙、三尖瓣叶的大小、形状以及瓣周组织距心室壁的圆周间隔个性化精准匹配。
  12. 根据权利要求10所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架第一锚定状态下，所述锚定钩袢经导管释放后，定位于患者腱索与腱索间隙位置处如数对位接合；所述三尖瓣锚定支架第二锚定状态下，所述多个锚定钩袢通过释放后的回形与三尖瓣锚定支架心房面和连接部合力作用形成夹持部，所述多个形变后的锚定钩袢与患者病变三尖瓣瓣叶及瓣下的腱索与瓣下组织预设交织而紧密结合。
  13. 根据权利要求10所述的分体式可精准锚定的人工生物三尖瓣系统，其特征在于，所述锚定钩袢对应三个瓣叶分为3组，每组数量对应患者腱索与腱索间隙的数量，分别为3-9个，优选为5个。
  14. 根据权利要求7所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架的连接部的心房面端部设置有用于嵌入介入三尖瓣支架的多个固定支杆，所述固定支杆沿心房面轴向延伸后其端部朝向锚定支架的轴心弯折。
  15. 根据权利要求14所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述三尖瓣锚定支架的连接部设置有用于嵌入介入三尖瓣支架流出端若干端头向心折钩，这些向心折钩与所述三尖瓣锚定支架的连接部心房面端部设置用于嵌入介入三尖瓣支架心房端的多个固定支杆上下合围，可防止介入三尖瓣释放时向心室侧移位。
  16. 根据权利要求12所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架第一锚定状态下，所述固定支杆保持与锚定支架连接部一致的角度，在所述三尖瓣锚定支架第二锚定状态下，所述多个固定支杆向心合围呈轴向平行，使固定支杆端头嵌于介入三尖瓣流入端的支架上，从结构上与介入三尖瓣牢固嵌合为一体，实现介入三尖瓣释放的0移位。
  17. 根据权利要求14所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述固定支杆为3-12个，优选为9个。
  18. 根据权利要求7所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架第一网格部分和第二网格部分为由可压缩的菱形网格、V形网格和/或六边形或多边形网格构成的单元网格形成，所述第一网格部分与第二网格部分适应性连接。
  19. 根据权利要求7所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架心房面的网格部分的外周缘与患者心房壁间隔1-2mm，优选间隔1.5mm。
  20. 根据权利要求7所述的分体式可精准锚定的人工生物三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架第二网格部分的内周缘直径与介入式人工生物三尖瓣各种相应大小规格的外径相匹配。
  21. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架表面部分或全部被覆有一层医用高分子薄膜。
  22. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述三尖瓣锚定支架的心房面、心室面和锚定支架的连接部为激光一体切割后三维成形结构或心房面、心室面和锚定支架的连接部分体加工再连接结构。
  23. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述锚定支架为具有形状记忆可回形性能的金属材料或非金属材料。
  24. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述锚定支 架为镍钛合金材质。
  25. 根据权利要求1-2任一所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，介入人工生物三尖瓣包括径向可压缩，并可被球囊扩张后呈圆柱状或不全圆柱状的钴铬合金支架，或径向可压缩自膨的镍钛合金支架，三个设置于所述支架内侧的扇形瓣叶，任一所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管或可支撑三个瓣叶交界固定的各种形态可压握的瓣膜支架。
  26. 根据权利要求25所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述瓣膜支架为钴基合金钴或铬合金或镍钛合金。
  27. 根据权利要求2所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入人工生物三尖瓣输送套件包括介入人工生物三尖瓣输送器、导引鞘、瓣膜压握器和充压泵。
  28. 根据权利要求27所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架输送器和介入人工生物三尖瓣输送器可经股静脉由下腔静脉路入或经颈静脉或锁骨下静脉由上腔静脉输送至三尖瓣位。
  29. 根据权利要求25所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，所述介入三尖瓣锚定支架先经导管路入患者病变三尖瓣位并释放为第一锚定状态，然后再经导管将介入人工生物三尖瓣送入锚定支架内，随着瓣膜被扩开，同时介入三尖瓣锚定支架被扩至第二锚定状态，同时支架连接部与介入三尖瓣的嵌合以及支架心室面完成与瓣下结构的进一步紧密结合形成最终锚定。
  30. 根据权利要求1-29所述的分体式可精准锚定的介入三尖瓣系统，其特征在于，每完成一次针对具体患者的个性化预设实现精准锚定的介入三尖瓣治疗过程，所有上述相关数据作为一个独立的数据单元，累积大量个性化的数据，通过人工智能实现所述分体式可精准锚定介入三尖瓣系统的智能化、规模化与产业化。
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