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 PDFInfo
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- 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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- tricuspid valve
- anchoring
- interventional
- stent
- split
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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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Abstract
Description
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。
Claims (30)
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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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