WO2020119463A1 - Controlled release valve stent - Google Patents

Abstract

A controlled release valve stent, comprising a valve sewing section (110), a positioning member (120) and an artificial valve (130); the artificial valve (130) is connected on the valve sewing section (110), and the valve sewing section (110) and the positioning member (120) are two independent components; after being compressed, the valve sewing section (110) and the positioning member (120) are located at different positions in the axial direction of a delivery sheath (170), the positioning member (120) being released before the valve sewing section (110); a proximal end of the valve sewing section (110) is provided with a connection structure (1101), and a distal end of the positioning member is provided with a mating structure (1210); when compressed and loaded in the delivery sheath (170), the connection structure (1101) is detachably connected on the mating structure (1210) so as to achieve the controlled release of the positioning member (120).

Description

可控释放的瓣膜支架Controllable release valve support

相关申请Related application

本申请要求2018年12月14日申请的，申请号为201811530670.9，名称为“一种可控释放的瓣膜支架”的中国专利申请的优先权，在此将其全文引入作为参考。This application requires the priority of the Chinese patent application with the application number 201811530670.9, entitled "A Controlled Release Valve Stent", which was filed on December 14, 2018. The entire content of which is hereby incorporated by reference.

技术领域Technical field

本申请涉及医疗器械领域，特别涉及一种可控释放的瓣膜支架。This application relates to the field of medical devices, and in particular to a controllable release valve stent.

背景技术Background technique

随着社会经济的发展和人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明超过75岁的老年人群瓣膜性心脏病发病率高达13.3％。外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者，Euro SCORE和/或STS评分高，外科手术死亡率高，甚至部分患者失去了手术机会。近年来，经导管瓣膜置入/修复术逐渐成熟并广泛应用，尤其是经导管主动脉瓣置入(TAVI)和经导管二尖瓣夹合术(MitraClip)的循证学依据较为充分，得到了欧洲和美国心脏瓣膜疾病治疗指南的推荐，是心脏瓣膜疾病介入治疗领域里程碑式的进展。With the development of the social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly over 75 years old is as high as 13.3%. Surgical treatment is still the first choice for patients with severe valvular disease, but for elderly patients with multiple organ diseases, a history of thoracotomy and poor cardiac function, EuroSCORE and/or STS scores are high, and surgical mortality is high , And even some patients have lost the opportunity for surgery. In recent years, transcatheter valve implantation/prosthesis has gradually matured and is widely used, especially the transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve clamping (MitraClip) are based on evidence-based evidence, The recommendations of European and American guidelines for the treatment of heart valve diseases are milestones in the interventional treatment of heart valve diseases.

自1992年Andersen等成功开展动物实验后，2002年Cribier等首次将TAVI应用于人体并取得了成功，此后TAVI技术快速发展，据不完全统计，全球约40个国家和地区开展此项技术，累计开展例数约15万例。应用的瓣膜类型主要为爱德华公司的EdwardsSapien和美敦力公司的CoreValve。Since Andersen and others successfully carried out animal experiments in 1992, Cribier and others first applied TAVI to the human body in 2002 and achieved success. Since then, TAVI technology has developed rapidly. According to incomplete statistics, this technology has been developed in about 40 countries and regions around the world. The number of cases was about 150,000. The valve types used are Edwards Sapien of Edwards and CoreValve of Medtronic.

但目前自体主动脉瓣关闭不全仍然被列为TAVR术的禁忌症。主要原因在于，支架瓣膜的准确定位和精确释放是TAVR手术中最为关键的技术点。主动脉瓣上有左右冠状动脉的开口，瓣下毗邻二尖瓣，如果定位释放不准确，则可能出现冠脉堵塞或二尖瓣大量反流等致命的并发症。传统的TAVR器械无论是SAPIEN或者是CoreValve均主要用于严重主动脉瓣狭窄患者，并不合适用于主动脉瓣反流患者。传统技术中，针对主动脉瓣反流患者的器械设计已经取得一定共识，例如国外的JenaValve、Acurate，国内的J-Valve，均是采用类似自体瓣叶定位件的结构，用于定位主动脉瓣的三个窦，这样有利于支架的准确定位植入。但是，以上器械目前仍多从经心尖入路，对患者创伤仍较大，不能算是严格意义上的经皮植入。针对如何兼顾自体瓣叶定位件和鞘管过大的问题，国内学者和工程师们作出 了一些概念上的尝试。However, at present, autologous aortic valve insufficiency is still listed as a contraindication for TAVR. The main reason is that the accurate positioning and precise release of stent valves are the most critical technical points in TAVR surgery. The aortic valve has openings for the left and right coronary arteries, and the valve is adjacent to the mitral valve. If the positioning and release are not accurate, fatal complications such as coronary occlusion or massive mitral regurgitation may occur. Traditional TAVR devices, whether SAPIEN or CoreValve, are mainly used in patients with severe aortic valve stenosis, and are not suitable for patients with aortic valve regurgitation. In the traditional technology, a certain consensus has been achieved on the design of devices for patients with aortic valve regurgitation. For example, JenaValve, Acurate abroad, and J-Valve in China all use a structure similar to the autogenous leaflet positioning member to locate the aortic valve The three sinuses are conducive to the accurate positioning of the stent. However, the above devices are still mostly approached from the apex of the heart, and the trauma to the patient is still large, and cannot be regarded as a strict percutaneous implantation. In view of how to take into account the problem of the self-valve leaf positioning member and the oversized sheath, domestic scholars and engineers have made some conceptual attempts.

专利CN201520325599.6和CN201511017536.5中描述了一款双环主动脉瓣膜支架，即在主体支架外加上一个W形的环形固定环，固定环的三个底脚用于固定在主动脉三个窦内，环形固定环用三个镍钛合金丝与主体支架连接。镍钛合金丝呈V形，其V形弯折与固定环V形弯折相对应。V形的镍钛合金丝能够拉伸为一字，使得固定环和支架的位置关系由内外关系成为上下关系。该设计的主要问题在于：1)环形固定环在释放后难以操作其对位主动脉窦，可调整性差；2)环形固定环一旦释放出鞘即卡在瓣膜窦部，无法进行重入鞘，手术风险大；3)环形固定环并未设置约束，导致其极容易在输送鞘管中弹跳，往往跳出后并不能完全实现与自体瓣膜的对中，加重调整难度；4)瓣膜完全释放后，自体瓣叶仍旧有贴靠主动脉窦壁堵塞冠脉的风险；5)上下支架运动的同轴性差，容易错位干涉。The patents CN201520325599.6 and CN201511017536.5 describe a double-ring aortic valve stent, that is, a W-shaped ring-shaped fixing ring is added to the main body stent, and the three feet of the fixing ring are used to fix the three aorta sinus , The ring-shaped fixed ring is connected to the main body bracket with three nickel-titanium alloy wires. The nickel-titanium alloy wire is V-shaped, and its V-shaped bend corresponds to the V-shaped bend of the fixing ring. The V-shaped nickel-titanium alloy wire can be stretched into a straight line, so that the positional relationship between the fixing ring and the bracket becomes an up-down relationship. The main problems of this design are: 1) the ring-shaped fixation ring is difficult to operate its alignment aortic sinus after release, and the adjustability is poor; 2) once the ring-shaped fixation ring is released from the sheath, it is stuck in the valve sinus and cannot be re-entered. Surgical risk is high; 3) The ring-shaped fixed ring is not constrained, which makes it very easy to bounce in the delivery sheath, and often does not fully achieve the alignment with the autologous valve after jumping out, which makes adjustment difficult; 4) After the valve is completely released, Autologous valve leaflets still have the risk of blocking the coronary arteries against the aortic sinus wall; 5) The coaxiality of the movement of the upper and lower stents is poor, and it is easy to dislocate and interfere.

专利CN201610029112.9中描述了一种经导管输送的主动脉瓣膜装置，与上述类似，其主体支架的上端形成呈三瓣型式的上喇叭口结构，主体支架的下侧还设置有用于定位的定位环，定位环与主体支架用定位线连接。该设计的主要问题在于：1)定位环释放后难以操作其对位主动脉窦，可调整性差；2)哪怕是已经对准主动脉窦，由于血流的冲击力，定位环将非常容易被冲出窦部，导致定位环夹子的端部无法抵触在瓣窦底部；3)瓣膜完全释放后，自体瓣叶仍旧有贴靠主动脉窦壁堵塞冠脉的风险；4)上下支架运动的同轴性差，容易错位干涉。Patent CN201610029112.9 describes a catheter-delivered aortic valve device. Similar to the above, the upper end of the main body stent forms a three-valve upper bell mouth structure, and the lower side of the main body stent is also provided with positioning for positioning The ring, the positioning ring and the main body bracket are connected with a positioning wire. The main problems of this design are: 1) it is difficult to operate its alignment aortic sinus after the positioning ring is released, and the adjustability is poor; 2) even if it is already aligned with the aortic sinus, the positioning ring will be very easily affected by the impact of blood flow Rushing out of the sinus, causing the end of the positioning ring clip to not touch the bottom of the valve sinus; 3) After the valve is fully released, the autologous valve leaflet still has the risk of blocking the coronary artery against the aortic sinus wall; 4) The same movement of the upper and lower stents Poor axiality, easy to misplace interference.

综上所述，传统技术已经能够部分兼顾自体瓣叶定位件和缩小输送导管，然而传统技术均存在定位环无法可控释放，同轴性差，以及释放后难以调整、固定和回收等问题，亟需一种同时解决以上问题的瓣膜置换装置。In summary, the traditional technology has been able to partially take into account the self-valve leaflet positioning member and the reduced delivery catheter. However, the traditional technology has problems that the positioning ring cannot be controlledly released, the coaxiality is poor, and it is difficult to adjust, fix and recover after release. A valve replacement device that simultaneously solves the above problems is needed.

发明内容Summary of the invention

本申请的目的是克服传统技术限制，针对传统分离式释放的主动脉瓣膜支架无法有效控制主体支架和定位件的位置，以及无法在完全释放定位件后调整、固定和回收等问题，开发了一种可控释放的瓣膜支架。The purpose of this application is to overcome the limitations of the traditional technology. In order to solve the problems that the traditional separated release aortic valve stent cannot effectively control the position of the main body stent and the positioning member, and cannot adjust, fix and recover after the positioning member is completely released, a A controllable release valve stent.

本申请的目的是通过以下技术方案实现的：The purpose of this application is achieved through the following technical solutions:

一种可控释放的瓣膜支架，包括瓣膜缝制段、定位部件和人工瓣膜，所述人工瓣膜被连接在所述瓣膜缝制段上，所述瓣膜缝制段与所述定位部件为两个独立构件，所述瓣膜缝制段与所述定位部件被压缩后位于输送鞘管轴线方向的不同位置，所述定位部件能够先于所述瓣膜缝制段释放，所述瓣膜缝制段的近端设置有连接结构，所述定位部件的远端设置 有配合结构，当被压缩装载在所述输送鞘管中时，所述连接结构可拆卸地连接在所述配合结构上，实现所述定位部件的可控释放。A controllable release valve stent includes a valve sewing section, a positioning member and an artificial valve, the artificial valve is connected to the valve sewing section, the valve sewing section and the positioning member are two An independent member, the valve sewing section and the positioning member are located at different positions in the axis direction of the delivery sheath after being compressed, the positioning member can be released before the valve sewing section, and the valve sewing section is near A connecting structure is provided at the end, and a matching structure is provided at the distal end of the positioning member. When compressed and loaded in the delivery sheath, the connecting structure is detachably connected to the matching structure to achieve the positioning Controlled release of parts.

本申请的目的还可以通过以下技术方案进一步实现：The purpose of this application can be further achieved through the following technical solutions:

在其中一个实施方式中，所述连接结构为线圈，所述配合结构为孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构，限位丝***已穿过所述配合结构的所述线圈。In one embodiment, the connection structure is a coil, and the mating structure is a hole. When the valve stent is compressed and loaded in the delivery sheath, the connection structure passes through the mating structure, The position wire is inserted into the coil that has passed through the fitting structure.

在其中一个实施方式中，所述连接结构为杆，所述配合结构为孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构。在其中一个实施方式中，所述连接结构上设置有限位孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构后，限位丝穿过所述限位孔。In one of the embodiments, the connecting structure is a rod, and the fitting structure is a hole, and when the valve stent is compressed and loaded in the delivery sheath, the connecting structure passes through the fitting structure. In one embodiment, the connection structure is provided with a limit hole, when the valve stent is compressed and loaded in the delivery sheath, after the connection structure passes through the fitting structure, the limit wire passes through Through the limit hole.

在其中一个实施方式中，所述瓣膜缝制段从所述输送鞘管完全释放后，所述瓣膜缝制段的近端部分与所述定位部件的近端重叠。In one of the embodiments, after the valve sewing section is completely released from the delivery sheath, the proximal end portion of the valve sewing section overlaps the proximal end of the positioning member.

在其中一个实施方式中，所述连接结构与所述瓣膜缝制段为一体结构。In one embodiment, the connection structure and the valve sewing section are an integrated structure.

在另一个实施方式中，所述配合结构与所述定位部件为一体结构。In another embodiment, the mating structure and the positioning member are an integral structure.

在其中一个实施方式中，所述瓣膜支架还设置有导引装置，所述导引装置为柔性线状结构或者带状结构，所述瓣膜缝制段上设置有滑动连接结构，所述导引装置的一端连接在所述定位部件上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述定位部件上，所述瓣膜缝制段能够沿所述导引装置滑动。在其中一个实施方式中，所述瓣膜缝制段完全释放后，所述导引装置骑跨在自体瓣叶的游离缘上。在其中一个实施方式中，所述自体瓣叶被所述导引装置骑跨并拉低，确保能够不堵塞冠脉开口。In one of the embodiments, the valve support is further provided with a guiding device, the guiding device is a flexible linear structure or a band structure, and a sliding connection structure is provided on the valve sewing section, the guiding One end of the device is connected to the positioning member, the other end of the guiding device passes through the sliding connection structure and is connected to the positioning member, and the valve sewing section can slide along the guiding device . In one of the embodiments, after the valve sewing section is completely released, the guiding device rides on the free edge of the native valve leaflet. In one of the embodiments, the autologous valve leaflet is straddled and pulled down by the guiding device, ensuring that the coronary artery opening cannot be blocked.

在其中一个实施方式中，所述瓣膜缝制段与所述定位部件的轴向相对位置由所述导引装置的长度所限位。In one embodiment, the axial relative position of the valve sewing section and the positioning member is limited by the length of the guide device.

在其中一个实施方式中，所述滑动连接结构为孔。在其中一个实施方式中，所述滑动连接结构与所述瓣膜缝制段为一体结构。在其中一个实施方式中，所述滑动连接结构位于所述瓣膜缝制段的近端部分。In one embodiment, the sliding connection structure is a hole. In one embodiment, the sliding connection structure and the valve sewing section are an integrated structure. In one of the embodiments, the sliding connection structure is located at a proximal portion of the valve sewing section.

在其中一个实施方式中，所述定位部件由锚定段和与所述锚定段的近端连接的夹持段组成，所述配合结构位于所述锚定段的远端。在其中一个实施方式中，所述锚定段释放后至少部分位于血管内。In one embodiment, the positioning component is composed of an anchoring segment and a clamping segment connected to the proximal end of the anchoring segment, and the mating structure is located at the distal end of the anchoring segment. In one of the embodiments, the anchor segment is at least partially within the blood vessel after release.

在其中一个实施方式中，所述锚定段为网格状结构或波浪形结构。在其中一个实施方式中，所述锚定段的表面覆盖有膜或者编织物。In one of the embodiments, the anchoring section is a grid-like structure or a wavy structure. In one of the embodiments, the surface of the anchoring section is covered with a film or braid.

在其中一个实施方式中，所述夹持段具有爪件，优选为具有三个爪件，所述爪件为U 形或者V形结构，所述瓣膜缝制段完全释放后自体瓣叶位于在所述爪件与所述瓣膜缝制段之间。In one of the embodiments, the clamping section has claw members, preferably three claw members, and the claw members are U-shaped or V-shaped. After the valve sewing section is completely released, the native valve leaflets are located at Between the claw member and the valve sewing section.

在其中一个实施方式中，所述瓣膜缝制段的近端配置有密封件，当所述瓣膜支架被植入时，所述密封件阻止血液通过所述瓣膜缝制段与自体组织之间的间隙。In one embodiment, a seal is provided at the proximal end of the valve sewing section, and when the valve stent is implanted, the seal prevents blood from passing between the valve sewing section and the autologous tissue gap.

在其中一个实施方式中，所述密封件为不连续的带状结构。在其中一个实施方式中，当所述瓣膜支架被植入时，所述爪件的下方对应所述密封件的不连续处。In one embodiment, the seal is a discontinuous band structure. In one embodiment, when the valve stent is implanted, the lower portion of the claw member corresponds to the discontinuity of the seal member.

同传统技术相比，本申请的优点在于：Compared with traditional technologies, the advantages of this application are:

1、传统技术中，对瓣膜缝制段以及定位部件往往需要两个控制部件进行释放，或者仅对瓣膜缝制段进行控制释放而对定位部件则无控制释放功能，前者实现起来必然增加鞘管的尺寸，更甚者控制部件会与植入器械产生干涉；后者实现起来定位部件在释放过程中会出现弹跳、脱落以及无法定位的风险。为解决上述问题，本申请利用瓣膜缝制段与定位部件可拆卸连接实现可控释放，能够避免所述定位部件在释放过程中从输送鞘管中弹跳而影响植入效果，便于控制和调整所述夹持段的角度和位置，同时能够在所述定位部件完全释放后重新入鞘，降低手术风险，并且本申请只需一个控制部件即可同时控制瓣膜缝制段和定位部件的释放和定位，能够最大限度减少鞘管尺寸。1. In the traditional technology, the valve sewing section and the positioning component often require two control parts to release, or only the valve sewing section is controlled to release and the positioning component has no control release function, the former will inevitably increase the sheath The size of the device, and even the control part will interfere with the implanted device; the latter realizes the risk that the positioning part will bounce, fall off and cannot be positioned during the release process. In order to solve the above problems, the present application utilizes the detachable connection of the valve sewing section and the positioning component to achieve controllable release, which can prevent the positioning component from bouncing from the delivery sheath during the release process and affecting the implantation effect, which is convenient for controlling and adjusting the position. The angle and position of the clamping section can simultaneously re-insert the sheath after the positioning member is completely released, reducing the surgical risk, and the application only needs one control member to simultaneously control the release and positioning of the valve sewing section and the positioning member , Can minimize the sheath size.

2、区别于传统技术，本申请在定位部件和主体瓣膜之间设置有导引装置，所述导引装置至少起到四个主要作用：1)所述瓣膜缝制段能够沿所述导引装置滑动到达指定位置，这样的移动方式能够大大增强瓣膜缝制段和定位部件之间的同轴性，避免两者在相互运动过程产生干涉和错位；2)在主体瓣膜与定位部件的对位及释放过程中，导引装置骑跨在原生自体瓣叶的游离缘上，能够有效限制自体瓣叶的游离缘活动，完全释放后更是自动压低自体瓣叶的游离缘高度，避免遮挡冠脉开口，同时增强了锚定效果；3)辅助实现所述定位部件的可控释放；4)导引装置还起到对主体瓣膜与定位部件相对位置的限位作用，便于医生操作。2. Different from the traditional technology, this application provides a guiding device between the positioning component and the main valve, the guiding device plays at least four main functions: 1) The valve sewing section can be guided along the The device slides to the specified position. This movement mode can greatly enhance the coaxiality between the valve sewing section and the positioning component, to avoid interference and misalignment between the two during the mutual movement process; 2) The alignment of the main valve and the positioning component And during the release process, the guide device rides on the free edge of the native autologous leaflet, which can effectively limit the free edge activity of the autologous leaflet. After the full release, it automatically reduces the height of the free edge of the autologous leaflet to avoid blocking the coronary artery The opening also enhances the anchoring effect; 3) assists in achieving a controlled release of the positioning component; 4) the guiding device also plays a role in limiting the relative position of the main valve and the positioning component, which is convenient for the doctor to operate.

3、区别于传统技术的固定方式，本申请中所述夹持段释放后首先定位在自体主动脉窦部，然后所述锚定段释放后至少部分位于血管内，利用升主动脉进行固定，这样设计的好处在于确保定位部件在释放后不会脱落，给予后续的主体瓣膜释放充足的时间。3. Different from the traditional fixation method, after the release of the clamping segment in the present application, it is first positioned in the sinus of the autologous aorta, and then the anchoring segment is at least partially located in the blood vessel and is fixed by the ascending aorta. The advantage of this design is to ensure that the positioning member will not fall off after release, giving the subsequent main body valve enough time to release.

4、区别于传统技术，本申请中所述密封件为不连续的带状结构，当所述瓣膜支架被植入时，所述爪件的下方对应所述密封件的不连续处，即密封件的连续处对应自体瓣叶的交界处，针对性的局部封堵技术在确保减少瓣周漏效果的同时，有效降低输送鞘管的直径。4. Different from the traditional technology, the sealing member in this application is a discontinuous band structure. When the valve stent is implanted, the lower part of the claw member corresponds to the discontinuity of the sealing member, that is, the seal The continuous part of the piece corresponds to the junction of the autologous valve leaflets. The targeted local sealing technology can effectively reduce the diameter of the delivery sheath while ensuring the effect of reducing paravalvular leakage.

附图说明BRIEF DESCRIPTION

为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。In order to more clearly explain the technical solutions in the embodiments or the conventional technology of the present application, the following will briefly introduce the drawings used in the embodiments or the description of the conventional technology. Obviously, the drawings in the following description are only For the embodiments of the application, for those of ordinary skill in the art, without paying any creative work, other drawings may be obtained based on the published drawings.

图1a-1c为本申请一实施例的可控释放的瓣膜支架的结构示意图，图1d-图1g为本申请一实施例中可控释放的瓣膜支架的配合结构和连接结构的多种实施方式的结构示意图。FIGS. 1a-1c are schematic structural diagrams of a controllable-release valve stent according to an embodiment of the present application, and FIGS. 1d-1g are various embodiments of a matching structure and a connecting structure of a controllable-release valve stent in an embodiment of the present application Schematic diagram of the structure.

图2为本申请另一实施例的可控释放的瓣膜支架的结构示意图。2 is a schematic structural diagram of a controllable-release valve stent according to another embodiment of the present application.

图3a和图3b为本申请再一种实施例的可控释放的瓣膜支架的结构示意图。图3c-图3e为本申请一实施例中瓣膜缝制段、定位部件以及导引装置的运动轨迹示意图。图3f为本申请中定位部件的一种实施方式的示意图。3a and 3b are schematic structural diagrams of a controllable-release valve stent according to yet another embodiment of the present application. 3c-3e are schematic diagrams of the motion trajectories of the valve sewing section, the positioning member and the guide device in an embodiment of the present application. FIG. 3f is a schematic diagram of an embodiment of a positioning component in this application.

图4a-图4l为本申请一实施例的可控释放的瓣膜支架进行输送及释放的操作步骤的示意图。4a-4l are schematic diagrams of operation steps of delivery and release of a controllable-release valve stent according to an embodiment of the present application.

图5a为本申请中另外一实施例的可控释放的瓣膜支架的结构示意图，图5b为本申请一实施例的密封件的结构示意图，图5c为本申请另一实施例的瓣膜缝制段与定位部件的的结构示意图。FIG. 5a is a schematic structural view of a controllable-release valve stent according to another embodiment of the present application, FIG. 5b is a structural schematic view of a sealing member according to an embodiment of the present application, and FIG. 5c is a valve sewing section of another embodiment of the present application Schematic diagram of the structure with positioning components.

具体实施方式detailed description

下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。The technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present application. The terminology used in the specification of the present application herein is for the purpose of describing specific embodiments only, and is not intended to limit the present application. The term "and/or" as used herein includes any and all combinations of one or more related listed items.

本申请所述的远端是指远离心尖的一端，所述的近端是指接近心尖的一端。The distal end mentioned in this application refers to the end far from the apex of the heart, and the proximal end refers to the end close to the apex of the heart.

具体实施例一：Specific example one:

如图1a-图1c所示，一种可控释放的瓣膜支架100，包括瓣膜缝制段110、定位部件120和人工瓣膜130，所述人工瓣膜130被连接在所述瓣膜缝制段110上，所述瓣膜缝制段110与所述定位部件120为两个独立构件，所述瓣膜缝制段110与所述定位部件120被压缩后位于输送鞘管170轴线方向的不同位置，所述定位部件120先于所述瓣膜缝制段110 释放，所述瓣膜缝制段110的近端设置有连接结构1101，所述定位部件120的远端设置有配合结构1210，当被压缩装载在输送鞘管170中时，所述连接结构1101可拆卸地连接在所述配合结构1210上，实现所述定位部件120的可控释放。As shown in FIGS. 1a-1c, a controllable release valve holder 100 includes a valve sewing section 110, a positioning member 120 and an artificial valve 130, the artificial valve 130 is connected to the valve sewing section 110 , The valve sewing section 110 and the positioning member 120 are two independent members. The valve sewing section 110 and the positioning member 120 are located at different positions in the axis direction of the delivery sheath 170 after being compressed, the positioning The component 120 is released before the valve sewing section 110. The proximal end of the valve sewing section 110 is provided with a connecting structure 1101, and the distal end of the positioning member 120 is provided with a fitting structure 1210. When compressed and loaded on the delivery sheath When in the tube 170, the connecting structure 1101 is detachably connected to the mating structure 1210, so as to realize the controlled release of the positioning member 120.

如图1d和图1e所示，作为一种实施方式，所述连接结构1101为杆，所述配合结构1210为孔，所述连接结构1101与所述瓣膜缝制段110为一体结构，所述配合结构1210与所述定位部件120为一体结构，当所述瓣膜支架100被压缩装载在输送鞘管中时，所述连接结构1101穿过所述配合结构1210。所述连接结构1101上设置有限位孔1102，当所述瓣膜支架100被压缩装载在输送鞘管170中时，所述连接结构1101穿过所述配合结构1210后，限位丝1103穿过所述限位孔1102，只有抽离所述限位丝1103，所述连接结构1101才能从所述配合结构1210中撤出。传统专利和技术中，对瓣膜缝制段以及定位部件往往需要两个控制部件进行释放，或者仅对瓣膜缝制段进行控制释放而对定位部件则无控制释放功能，前者实现起来必然增加鞘管的尺寸，更甚者控制部件会与植入器械产生干涉；后者实现起来定位部件在释放过程中会出现弹跳、脱落以及无法定位的风险。为解决上述问题，本申请利用瓣膜缝制段110与定位部件120可拆卸连接实现可控释放，即通过所述瓣膜缝制段110和所述定位部件120间的相互约束，实现所述定位部件120的可控释放，避免所述定位部件120在释放过程中从输送鞘管中弹跳而影响植入效果，便于控制和调整所述夹持段122的角度和位置，同时能够在所述定位部件120完全释放后重新入鞘，降低手术风险。相比于传统技术中分别对瓣膜主体和定位部件进行控制，本申请只需一个控制部件即可同时控制瓣膜缝制段110和定位部件120的释放和定位，能够最大限度减少输送鞘管170尺寸。As shown in FIGS. 1d and 1e, as an embodiment, the connecting structure 1101 is a rod, the matching structure 1210 is a hole, and the connecting structure 1101 and the valve sewing section 110 are an integrated structure. The fitting structure 1210 and the positioning member 120 are an integral structure. When the valve support 100 is compressed and loaded in the delivery sheath, the connecting structure 1101 passes through the fitting structure 1210. The connection structure 1101 is provided with a limit hole 1102. When the valve stent 100 is compressed and loaded in the delivery sheath 170, after the connection structure 1101 passes through the fitting structure 1210, the limit wire 1103 passes through the In the limiting hole 1102, the connecting structure 1101 can be withdrawn from the matching structure 1210 only when the limiting wire 1103 is pulled away. In traditional patents and technologies, two control components are often required to release the valve sewing section and the positioning component, or only the valve sewing section is controlled to release, but the positioning component has no control release function. The former will inevitably increase the sheath The size of the device, and even the control part will interfere with the implanted device; the latter realizes the risk that the positioning part will bounce, fall off and cannot be positioned during the release process. In order to solve the above problems, the present application utilizes the detachable connection of the valve sewing section 110 and the positioning member 120 to achieve controllable release, that is, the positioning member is realized by mutual restraint between the valve sewing section 110 and the positioning member 120 Controllable release of 120 to prevent the positioning member 120 from bouncing from the delivery sheath during the release process and affecting the implantation effect, which is convenient for controlling and adjusting the angle and position of the clamping section 122, while being able to After 120 is completely released, the sheath is reinserted to reduce the risk of surgery. Compared with the conventional technology that controls the valve body and the positioning component separately, the present application requires only one control component to simultaneously control the release and positioning of the valve sewing section 110 and the positioning component 120, which can minimize the size of the delivery sheath 170 .

作为另一种实施方式，如图1f所示，所述连接结构1101为线圈，所述配合结构1210为孔，当所述瓣膜支架100被压缩装载在输送鞘管170中时，所述连接结构1101穿过所述配合结构1210，限位丝1103***已穿过配合结构1210的所述线圈。作为一种实施方式，如图1g所示，所述连接结构1101上设置有凹槽，所述配合结构1210上设置有凸起，所述凹槽和所述凸起相互匹配。As another embodiment, as shown in FIG. 1f, the connection structure 1101 is a coil, and the fitting structure 1210 is a hole. When the valve support 100 is compressed and loaded in the delivery sheath 170, the connection structure 1101 passes through the fitting structure 1210, and a limit wire 1103 is inserted into the coil that has passed through the fitting structure 1210. As an embodiment, as shown in FIG. 1g, the connecting structure 1101 is provided with a groove, and the matching structure 1210 is provided with a protrusion, and the groove and the protrusion match each other.

具体实施例二：Specific embodiment two:

如图2所示，作为另一种实施方式，一种可控释放的瓣膜支架200，包括瓣膜缝制段210、定位部件220、人工瓣膜230和导引装置240，所述人工瓣膜230被连接在所述瓣膜缝制段210上，所述瓣膜缝制段210与所述定位部件220为两个独立构件并通过所述导引装置240连接，所述导引装置240为柔性线状结构或者带状结构。所述瓣膜缝制段210与所述定位部件220被压缩后位于输送鞘管轴线方向的不同位置，所述定位部件220先于所 述瓣膜缝制段210释放，所述瓣膜缝制段210的近端设置有连接结构2101，所述定位部件220的远端设置有配合结构2210，当被压缩装载在输送鞘管中时，所述连接结构2101可拆卸地连接在所述配合结构2210上，实现所述定位部件220的可控释放。作为一种实施方式，所述瓣膜缝制段210上设置有滑动连接结构211，所述导引装置240的一端连接在所述定位部件220上，所述导引装置240的另一端穿过所述滑动连接结构211后连接在所述定位部件220上，所述滑动连接结构211位于所述瓣膜缝制段210的近端部分，所述瓣膜缝制段210能够沿所述导引装置240滑动。As shown in FIG. 2, as another embodiment, a controllable release valve holder 200 includes a valve sewing section 210, a positioning member 220, an artificial valve 230, and a guiding device 240, and the artificial valve 230 is connected On the valve sewing section 210, the valve sewing section 210 and the positioning member 220 are two independent members and are connected by the guide device 240, and the guide device 240 is a flexible linear structure or Banded structure. After the valve sewing section 210 and the positioning member 220 are compressed, they are located at different positions in the axis direction of the delivery sheath. The positioning member 220 is released before the valve sewing section 210. A connecting structure 2101 is provided at the proximal end, and a matching structure 2210 is provided at the distal end of the positioning member 220. When compressed and loaded in the delivery sheath, the connecting structure 2101 is detachably connected to the matching structure 2210, A controlled release of the positioning component 220 is achieved. As an embodiment, the valve sewing section 210 is provided with a sliding connection structure 211, one end of the guide device 240 is connected to the positioning member 220, and the other end of the guide device 240 passes through the The sliding connection structure 211 is then connected to the positioning member 220. The sliding connection structure 211 is located at a proximal portion of the valve sewing section 210, and the valve sewing section 210 can slide along the guiding device 240 .

作为一种实施方式，所述定位部件220沿周向等分配备有三个爪件2221，所述爪件2221为U形或者V形结构，用以配合三个主动脉窦生理结构，所述爪件2221在释放后到达自体瓣叶的背后和主动脉瓣窦底，以完成定位。所述瓣膜缝制段210完全释放后，自体瓣叶位于在所述爪件2221与所述瓣膜缝制段210之间。所述导引装置240与所述定位部件220的连接点与所述爪件2221在轴线方向上错开布置，这样使得导引装置240能够从自体瓣叶的交界处穿过从而不妨碍自体瓣叶的运动。所述瓣膜缝制段210能够沿所述导引装置240滑动。所述瓣膜缝制段210从所述输送鞘管完全释放后，所述瓣膜缝制段210的近端部分与所述定位部件220的近端重叠。As an implementation manner, the positioning member 220 is equally divided along the circumferential direction with three claw members 2221. The claw members 2221 are U-shaped or V-shaped structures for matching three physiological aortic sinus physiological structures. After release, the piece 2221 reaches the back of the autologous valve leaflet and the aortic valve sinus floor to complete the positioning. After the valve sewing section 210 is completely released, the native valve leaflet is located between the claw member 2221 and the valve sewing section 210. The connection point of the guiding device 240 and the positioning member 220 is arranged staggered with respect to the claw member 2221 in the axial direction, so that the guiding device 240 can pass through the junction of the autologous leaflets without hindering the autologous leaflets exercise. The valve sewing section 210 can slide along the guiding device 240. After the valve sewing section 210 is completely released from the delivery sheath, the proximal end portion of the valve sewing section 210 overlaps the proximal end of the positioning member 220.

如图3a和图3b所示，在一个实施方式中，所述定位部件220由锚定段221和夹持段222组成，所述锚定段221释放后至少部分位于血管内，所述配合结构2210位于所述锚定段221的远端。所述夹持段222位于所述锚定段221的近端，所述夹持段222的远端与所述锚定段221的近端连接，在此实施例中，所述夹持段222与所述锚定段221为一体构件。所述导引装置240的一端2401连接在所述夹持段222上，所述导引装置240的另一端2402从所述滑动连接结构211中穿过后连接在所述锚定段221上，所述瓣膜缝制段210能够沿所述导引装置240滑动。As shown in FIGS. 3a and 3b, in one embodiment, the positioning member 220 is composed of an anchoring segment 221 and a clamping segment 222. After the anchoring segment 221 is released, it is at least partially located in the blood vessel. 2210 is located at the distal end of the anchoring section 221. The clamping section 222 is located at the proximal end of the anchoring section 221, and the distal end of the clamping section 222 is connected to the proximal end of the anchoring section 221. In this embodiment, the clamping section 222 The anchoring section 221 is an integral member. One end 2401 of the guiding device 240 is connected to the clamping section 222, and the other end 2402 of the guiding device 240 passes through the sliding connection structure 211 and is connected to the anchoring section 221. The valve sewing section 210 can slide along the guiding device 240.

图3c-图3e为本申请的一个实施方式中，瓣膜缝制段210、定位部件220以及导引装置240的运动轨迹示意图。所述导引装置240位于所述定位部件220与所述瓣膜缝制段210之间，这样能够最大限度避免所述导引装置240在滑动过程中损伤缝合在所述瓣膜缝制段210内的所述人工瓣膜230，而且能够为后续压低自体瓣叶游离缘提供可能。具体的，在一实施例中，在所述瓣膜缝制段210的近端部分设置有三个所述滑动连接结构211，所述滑动连接结构211为孔。在一实施例中，所述滑动连接结构211与所述瓣膜缝制段210为一体结构。所述瓣膜缝制段210完全释放后，所述导引装置240骑跨在自体瓣叶280的游离缘上。所述瓣膜缝制段210与所述定位部件220的轴向相对位置由所述导引装置240的长度所限位，实际上，通过调整所述导引装置240的长度，能够实现当所述瓣膜缝制段210 被限位在患者瓣环位置的同时，所述自体瓣叶280被所述导引装置240骑跨并拉低，确保不堵塞冠脉开口。FIGS. 3c-3e are schematic diagrams of movement trajectories of the valve sewing section 210, the positioning member 220, and the guide device 240 in one embodiment of the present application. The guide device 240 is located between the positioning member 220 and the valve sewing section 210, so as to avoid the guide device 240 from damage to the valve sewing section 210 during sliding The artificial valve 230 can provide the possibility of subsequently depressing the free edge of the autologous valve leaflet. Specifically, in an embodiment, three sliding connection structures 211 are provided at the proximal end of the valve sewing section 210, and the sliding connection structures 211 are holes. In an embodiment, the sliding connection structure 211 and the valve sewing section 210 are an integrated structure. After the valve sewing section 210 is completely released, the guiding device 240 rides on the free edge of the native valve leaflet 280. The axial relative position of the valve sewing section 210 and the positioning member 220 is limited by the length of the guide device 240. In fact, by adjusting the length of the guide device 240, the While the valve sewing section 210 is limited to the position of the annulus of the patient, the native valve leaflets 280 are ridden and pulled down by the guiding device 240 to ensure that the coronary artery opening is not blocked.

如图3f所示，在一实施例中，所述锚定段221为网格状结构，所述锚定段221的表面覆盖有膜或者编织物260用于避免血管夹层。在另一个实施方式中，所述锚定段221为波浪形结构(未示出)。所述导引装置240与所述锚定段221的连接点位于所述锚定段221的远端部分上，所述瓣膜缝制段210与所述定位部件220被压缩后位于输送鞘管的不同位置，所述导引装置240能够辅助所述定位部件220在释放后重新入鞘，尤其是当所述锚定段221的绝大部分被释放后能够重新入鞘，医生将视定位效果可选择重新回撤和释放所述定位部件220，极大提高手术成功率。As shown in FIG. 3f, in an embodiment, the anchoring section 221 is a grid-like structure, and the surface of the anchoring section 221 is covered with a membrane or braid 260 to avoid vascular dissection. In another embodiment, the anchoring section 221 is a wave-shaped structure (not shown). The connection point of the guiding device 240 and the anchoring section 221 is located on the distal end portion of the anchoring section 221, and the valve sewing section 210 and the positioning member 220 are located on the delivery sheath after being compressed In different positions, the guiding device 240 can assist the positioning member 220 to re-insert the sheath after being released, especially when most of the anchoring section 221 is released and can be re-inserted into the sheath. Choosing to retract and release the positioning member 220 greatly improves the success rate of the operation.

综上所述，区别于传统技术，本申请的所述导引装置至少起到四个主要作用：1)所述瓣膜缝制段能够沿所述导引装置滑动到达指定位置，这样的移动方式能够大大增强瓣膜缝制段和定位部件之间的同轴性，避免两者在相互运动过程产生干涉和错位；2)在主体瓣膜与定位部件的对位及释放过程中，导引装置骑跨在原生自体瓣叶的游离缘上，能够有效限制自体瓣叶的游离缘活动，完全释放后更是自动压低自体瓣叶的游离缘高度，避免遮挡冠脉开口，同时增强了锚定效果；3)辅助实现所述定位部件的可控释放；4)导引装置还起到对主体瓣膜与定位部件相对位置的限位作用，便于医生操作。In summary, different from the traditional technology, the guiding device of the present application has at least four main functions: 1) The valve sewing section can slide along the guiding device to a specified position, such a movement method It can greatly enhance the coaxiality between the sewed section of the valve and the positioning component, to avoid interference and misalignment between the two during the mutual movement process; 2) During the alignment and release of the main valve and the positioning component, the guide device rides On the free edge of the native autologous leaflet, it can effectively limit the free edge activity of the autologous leaflet, and when fully released, it automatically reduces the height of the free edge of the autologous leaflet, avoids covering the coronary opening, and enhances the anchoring effect; 3 ) Auxiliary realization of the controlled release of the positioning component; 4) The guiding device also plays a role in limiting the relative position of the main body valve and the positioning component, which is convenient for the doctor to operate.

为了更好地阐明本实施方案，所述瓣膜支架200可以通过以下操作步骤进行输送及释放：In order to better illustrate this embodiment, the valve stent 200 can be delivered and released through the following steps:

(1)如图4a和图4b所示，将所述瓣膜支架200压缩装载在输送鞘管270内，所述瓣膜缝制段210位于所述定位部件220的远端，在影像设备的辅助下，将植入物经股动脉或类似动脉途径入路输送至患者病变部位；(1) As shown in FIGS. 4a and 4b, the valve holder 200 is compressed and loaded in a delivery sheath 270, and the valve sewing section 210 is located at the distal end of the positioning member 220, with the assistance of an imaging device , The implant is delivered to the patient's lesion through the femoral artery or similar artery approach;

(2)如图4c和图4d所示，逐步释放所述夹持段222直至所有所述爪件2221张开角度，所述夹持段222释放后位于自体瓣膜窦部，此时所述锚定段221仍被压缩在输送鞘管内；(2) As shown in FIGS. 4c and 4d, gradually release the clamping section 222 until all the claw members 2221 are opened at an angle, and the clamping section 222 is located in the sinus of the autologous valve after the release, and the anchor The fixed section 221 is still compressed in the delivery sheath;

(3)如图4e和图4f所示，调整所述爪件2221的角度和位置，到达自体瓣叶的背后和主动脉瓣窦底后，逐步释放所述锚定段221，所述锚定段221被释放后至少部分位于血管内提供锚定力，由于所述瓣膜缝制段210和所述定位部件220间的相互约束，所述锚定段221并不会弹跳，而且这种利用升主动脉进行固定的方式，所述定位部件220在完全释放后并不会因血流冲刷而移位脱落，给予后续的主体瓣膜释放充足的时间。更重要的是，若医生不满意所述定位部件220的位置，在所述导引装置240的辅助下，可重新将所述定位部件220收入鞘中，重新释放或者撤离人体，手术风险大大降低；(3) As shown in FIGS. 4e and 4f, after adjusting the angle and position of the claw member 2221 to reach the back of the autologous valve leaflet and the aortic valve sinus floor, gradually release the anchoring section 221, the anchoring After the segment 221 is released, it is at least partially located in the blood vessel to provide anchoring force. Due to the mutual restraint between the valve sewing segment 210 and the positioning member 220, the anchoring segment 221 does not bounce, and this utilization increases In the way of fixing the aorta, the positioning member 220 will not be displaced due to the flushing of blood flow after it is completely released, allowing sufficient time for the subsequent release of the main valve. More importantly, if the doctor is not satisfied with the position of the positioning member 220, with the assistance of the guiding device 240, the positioning member 220 can be re-entered into the sheath, re-released or evacuated from the human body, the risk of surgery is greatly reduced ;

(4)如图4g和图4h所示，在确定位置后，抽离所述限位丝2103，所述连接结构2101从所述配合结构2210中撤出，所述锚定段221被完全释放锚定在升主动脉内；(4) As shown in FIGS. 4g and 4h, after the position is determined, the limit wire 2103 is pulled away, the connecting structure 2101 is withdrawn from the fitting structure 2210, and the anchoring section 221 is completely released Anchored in the ascending aorta;

(5)如图4i和图4j所示，将导引Tip头重新与鞘管合拢，这样的操作可帮助压缩着所述瓣膜缝制段210的输送鞘管270更好地通过自体瓣叶。沿着所述导引装置240推动输送鞘管直至被所述导引装置240的长度所限位，此时自体瓣叶280被所述导引装置240骑跨并压低；(5) As shown in FIGS. 4i and 4j, the guide tip is closed with the sheath again. Such an operation can help compress the delivery sheath 270 of the valve sewing section 210 to better pass the native valve leaflet. Push the delivery sheath along the guiding device 240 until it is limited by the length of the guiding device 240, at this time the autologous leaflet 280 is straddled and depressed by the guiding device 240;

(6)如图4k和图4l所示，逐步释放所述瓣膜缝制段210直至其完全释放，所述瓣膜缝制段210完全释放后，自体瓣叶维持被压低的形态位于所述爪件2221与所述瓣膜缝制段210之间；(6) As shown in FIGS. 4k and 4l, gradually release the valve sewing section 210 until it is completely released. After the valve sewing section 210 is completely released, the self-valve leaflet maintains the depressed state in the claw member Between 2221 and the valve sewing section 210;

(7)撤离输送导管。(7) Withdraw the delivery catheter.

所述瓣膜支架200还可以经心尖、经房间隔穿刺等途径进行输送及释放，操作步骤与上文类似，不再赘述。The valve stent 200 can also be delivered and released through the apex, transatrial septum puncture and other methods. The operation steps are similar to the above and will not be repeated here.

具体实施例三：Specific embodiment three:

如图5a所示，与之前实施例不同在于，所述瓣膜缝制段310的近端配置有密封件370，当所述瓣膜支架300被植入时，所述密封件370阻止血液通过所述瓣膜缝制段与自体组织之间的间隙。由于自体瓣叶的辅助防漏作用，自体瓣叶380的瓣叶交界区域最容易产生反流，作为一种实施方式，如图5b所示，所述密封件370为不连续的带状结构，当所述瓣膜支架300被植入时，所述爪件3221(3221a、3221b、3221c)的下方对应所述密封件370的不连续处，即密封件的连续处对应自体瓣叶的交界处，如此针对性的局部封堵技术在确保减少瓣周漏效果的同时，有效降低输送鞘管的直径。As shown in FIG. 5a, unlike the previous embodiment, a seal 370 is configured at the proximal end of the valve sewing section 310. When the valve stent 300 is implanted, the seal 370 prevents blood from passing through the The gap between the sewed section of the valve and the autologous tissue. Due to the auxiliary leakage prevention effect of the autologous leaflets, the leaflet junction area of the autologous leaflets 380 is most likely to produce backflow. As an embodiment, as shown in FIG. 5b, the seal 370 is a discontinuous band structure. When the valve stent 300 is implanted, the lower part of the claw member 3221 (3221a, 3221b, 3221c) corresponds to the discontinuity of the seal 370, that is, the continuous place of the seal corresponds to the junction of the autologous valve leaflets, Such targeted local occlusion technology can effectively reduce the diameter of the delivery sheath while ensuring the effect of reducing paravalvular leakage.

如图5c所示，所述爪件3221的端部被设置为向所述夹持段322的轴线方向内拢的结构。优选的，所述瓣膜缝制段310的外轮廓上设置有凹陷3105，所述瓣膜缝制段310完全释放后，所述凹陷3105与所述爪件3221内拢的结构相匹配，这样设计的好处在于方便定位部件和主体瓣膜的对位和固定，有利于锚定和减少瓣周漏。As shown in FIG. 5c, the end of the claw member 3221 is configured to be inwardly directed toward the axis of the clamping section 322. Preferably, the outer contour of the valve sewing section 310 is provided with a recess 3105. After the valve sewing section 310 is completely released, the recess 3105 matches the structure of the claw member 3221 which is folded in this way. The advantage is that it is convenient for the positioning and fixing of the positioning component and the main valve, which is beneficial for anchoring and reducing paravalvular leakage.

本申请实施例的可控释放的瓣膜支架除了应用在主动脉瓣外，还可以应用在二尖瓣、三尖瓣以及肺动脉瓣产品中。In addition to the aortic valve, the controllable-release valve stent of the embodiment of the present application can also be used in mitral valve, tricuspid valve, and pulmonary valve products.

以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be arbitrarily combined. To simplify the description, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, All should be considered within the scope of this description.

以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说， 在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。The above-mentioned embodiment only expresses several implementation manners of the present application, and its description is more specific and detailed, but it cannot be understood as limiting the scope of the patent application. It should be noted that, for a person of ordinary skill in the art, without departing from the concept of the present application, a number of modifications and improvements can also be made, which all fall within the protection scope of the present application. Therefore, the protection scope of the patent of this application shall be subject to the appended claims.

Claims (10)

1. 一种可控释放的瓣膜支架，其特征在于，包括瓣膜缝制段、定位部件和人工瓣膜，所述人工瓣膜被连接在所述瓣膜缝制段上，所述瓣膜缝制段与所述定位部件为两个独立构件，所述瓣膜缝制段与所述定位部件被压缩后位于输送鞘管轴线方向的不同位置，所述定位部件能够先于所述瓣膜缝制段释放，所述瓣膜缝制段的近端设置有连接结构，所述定位部件的远端设置有配合结构，当被压缩装载在所述输送鞘管中时，所述连接结构可拆卸地连接在所述配合结构上，实现所述定位部件的可控释放。A controllable release valve stent, characterized by comprising a valve sewing section, a positioning member and an artificial valve, the artificial valve is connected to the valve sewing section, the valve sewing section and the positioning The component is two independent components, and the valve sewing section and the positioning member are located at different positions in the axis direction of the delivery sheath after being compressed, the positioning member can be released before the valve sewing section, and the valve slit A connecting structure is provided at the proximal end of the manufacturing section, and a matching structure is provided at the distal end of the positioning member. When compressed and loaded in the delivery sheath, the connecting structure is detachably connected to the matching structure. A controllable release of the positioning component is achieved.
2. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述连接结构为线圈，所述配合结构为孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构，限位丝***已穿过所述配合结构的所述线圈。The controllable release valve support according to claim 1, wherein the connection structure is a coil, and the fitting structure is a hole. When the valve support is compressed and loaded in the delivery sheath, the The connection structure passes through the mating structure, and the limit wire is inserted into the coil that has passed through the mating structure.
3. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述连接结构为杆，所述配合结构为孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构。The controllable release valve support according to claim 1, wherein the connecting structure is a rod and the fitting structure is a hole, when the valve support is compressed and loaded in the delivery sheath, the The connection structure passes through the mating structure.
4. 如权利要求3所述的可控释放的瓣膜支架，其特征在于，所述连接结构上设置有限位孔，当所述瓣膜支架被压缩装载在所述输送鞘管中时，所述连接结构穿过所述配合结构后，限位丝穿过所述限位孔。The controllable release valve support according to claim 3, wherein the connection structure is provided with a limited position hole, and when the valve support is compressed and loaded in the delivery sheath, the connection structure passes through After passing through the matching structure, the limit wire passes through the limit hole.
5. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述瓣膜缝制段从所述输送鞘管完全释放后，所述瓣膜缝制段的近端部分与所述定位部件的近端重叠。The controllable-release valve stent according to claim 1, wherein after the valve sewing section is completely released from the delivery sheath, the proximal portion of the valve sewing section and the positioning member The proximal ends overlap.
6. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述可控释放的瓣膜支架还设置有导引装置，所述导引装置为柔性线状结构或者带状结构，在所述瓣膜缝制段上设置有滑动连接结构，所述导引装置的一端连接在所述定位部件上，所述导引装置的另一端从所述滑动连接结构中穿过后连接在所述定位部件上，所述瓣膜缝制段能够沿所述导引装置滑动。The controllable-release valve support according to claim 1, wherein the controllable-release valve support is further provided with a guide device, and the guide device is a flexible linear structure or a belt-like structure, The valve sewing section is provided with a sliding connection structure, one end of the guide device is connected to the positioning member, and the other end of the guide device passes through the sliding connection structure and is connected to the positioning member Above, the valve sewing section can slide along the guiding device.
7. 如权利要求6所述的可控释放的瓣膜支架，其特征在于，所述滑动连接结构位于所述瓣膜缝制段的近端部分。The controllable-release valve stent according to claim 6, wherein the sliding connection structure is located at a proximal portion of the valve sewing section.
8. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述定位部件由锚定段和与所述锚定段近端连接的夹持段组成，所述配合结构位于所述锚定段的远端。The controllable release valve stent according to claim 1, wherein the positioning member is composed of an anchoring segment and a clamping segment connected to the proximal end of the anchoring segment, and the cooperation structure is located at the anchor The far end of the segment.
9. 如权利要求1所述的可控释放的瓣膜支架，其特征在于，所述瓣膜缝制段的近端配置有密封件。The controllable-release valve stent according to claim 1, wherein a seal is arranged at the proximal end of the valve sewing section.
10. 如权利要求9所述的可控释放的瓣膜支架，其特征在于，所述密封件为不连续的 带状结构。The controllable-release valve stent according to claim 9, wherein the sealing member has a discontinuous band structure.

Images