技术领域Technical field
本申请涉及医疗器械领域，具体涉及一种心脏瓣膜成形系统。This application relates to the field of medical devices, and specifically to a heart valve forming system.
背景技术Background technique
随着人口老龄化的来临，心脏瓣膜疾病的发病率上升明显。特别是二尖瓣反流（mitral regurgitation，MR），其发病率是主动脉瓣狭窄患者的5倍以上。据估计，在我国有超过1000万的重度MR患者。MR是由于二尖瓣叶及其结构发生改变导致二尖瓣前后叶吻合不良，血液从左心室逆流到左心房，从而引起一些症状。根据发病机制，MR可分为原发性（器质性）和继发性（功能性），大约各占50%。轻度MR患者可以在很长时间内不出现临床症状，预后较好。重度MR 患者可伴有心悸、胸闷、气急等症状。急性重度MR患者耐受性很差，很容易出现死亡。临床研究表明通过药物治疗只能改善患者症状，而不能延长其生存时间或手术时机。外科瓣膜修复或置换术被公认为治疗MR的标准方法，已被证实能够缓解患者症状及延长其生存时间。但是，外科手术治疗具有创伤大、术后恢复慢、术后疼痛明显、风险高等缺点。同时，有50%的MR患者因为心功能低下、高龄、有开胸病史等高危因素不适合外科手术而得不到有效治疗。近十几年来，经导管二尖瓣介入治疗技术快速发展，特别是MitraClip的上市为诸多患者带来了希望。最新研究表明，MitraClip对功能性反流的治疗效果优于药物治疗。面对巨大的市场，各大企业与资本纷纷踏足MR治疗的行列中。As the population ages, the incidence of heart valve disease has increased significantly. In particular, the incidence of mitral regurgitation (MR) is more than five times that of patients with aortic stenosis. It is estimated that there are more than 10 million patients with severe MR in my country. MR is caused by changes in the mitral valve leaflets and their structure, resulting in poor anastomosis between the anterior and posterior mitral valve leaflets, and blood flowing backward from the left ventricle to the left atrium, causing some symptoms. According to the pathogenesis, MR can be divided into primary (organic) and secondary (functional), each accounting for approximately 50%. Patients with mild MR may not develop clinical symptoms for a long time and have a good prognosis. Patients with severe MR may be accompanied by symptoms such as palpitations, chest tightness, and shortness of breath. Patients with acute severe MR have poor tolerance and are prone to death. Clinical studies have shown that drug treatment can only improve patients' symptoms, but cannot prolong their survival time or the timing of surgery. Surgical valve repair or replacement is recognized as the standard method for treating MR and has been proven to relieve patients' symptoms and prolong their survival time. However, surgical treatment has the disadvantages of large trauma, slow postoperative recovery, significant postoperative pain, and high risks. At the same time, 50% of MR patients do not receive effective treatment because they are not suitable for surgery due to high-risk factors such as low cardiac function, advanced age, and history of thoracotomy. In the past decade, transcatheter mitral valve interventional treatment technology has developed rapidly, especially the launch of MitraClip, which has brought hope to many patients. The latest research shows that MitraClip is more effective in treating functional reflux than medication. Facing the huge market, major companies and capital have stepped into the ranks of MR treatment.
专利CN2022101932385公开了一种用于修复瓣膜的植入器械，包括成形术装置，用于控制成形术装置收缩的控制元件、用于将成形术装置与心脏组织锚定的固定元件，所述成形术装置包括至少两个缩环构件，所述的至少两个缩环构件通过所述固定元件相邻地锚定在自体瓣环或心房组织处，操纵所述控制元件使得所述缩环构件收缩，并且所述缩环构件相邻的端部均向自体瓣膜中心靠拢。而申请人在试验中发现，发现存在以下技术问题：1.虽然缩环后，两个端部向瓣膜中心移动的幅度明显，但是由于前瓣叶区域靠近主动脉瓣膜，前瓣区域移动幅度过大的话，会影响主动脉的血流供应，导致并发症；2.控制丝设置在缩环构件的端部，在收缩时，端部受力集中，对控制丝的强度考验较大。Patent CN2022101932385 discloses an implantable device for valve repair, including a arthroplasty device, a control element for controlling the contraction of the arthroplasty device, and a fixation element for anchoring the arthroplasty device to cardiac tissue. The device includes at least two shrinking ring members, the at least two shrinking ring members are adjacently anchored at the native valve annulus or atrial tissue through the fixation element, and the control element is manipulated to cause the shrinking ring members to contract, And the adjacent ends of the shrinking ring member are all close to the center of the native valve. The applicant discovered during the test that the following technical problems existed: 1. Although the two ends moved significantly toward the center of the valve after shrinking the ring, because the anterior valve leaflet area was close to the aortic valve, the anterior valve area moved too much. If it is too large, it will affect the blood flow supply of the aorta and lead to complications; 2. The control wire is set at the end of the shrink ring member. When shrinking, the force on the end is concentrated, which will greatly test the strength of the control wire.
综上所述尽管以上技术在临床上都有一些成效，但是都存在不足，亟需一种新的一种心脏瓣膜成形系统来解决以上问题。In summary, although the above technologies have some clinical results, they all have shortcomings, and a new cardiac valvuloplasty system is urgently needed to solve the above problems.
发明内容Contents of the invention
鉴于以上和其它构思，而提出了本申请。本申请的主要目的是克服现有技术的一些问题和不足。In view of the above and other concepts, the present application is proposed. The main purpose of this application is to overcome some problems and deficiencies of the prior art.
在房室瓣手术的应用方面，本申请旨在针对心脏瓣膜出现病变且需要介入治疗的患者提供一种心脏瓣膜成形系统，从而可解决现有技术中前瓣叶区域移动距离较大、对主动脉瓣膜血流供应造成影响等问题。In terms of the application of atrioventricular valve surgery, this application aims to provide a heart valve shaping system for patients with heart valve disease and need interventional treatment, thereby solving the problem of the large movement distance of the anterior valve leaflet area and the impact on the main body in the existing technology. Problems such as the impact on the blood flow supply of arterial valves.
解决本发明技术问题所采用的技术方案是：一种心脏瓣膜成形系统，包括收缩骨架、覆在收缩骨架上的覆盖层、用于控制收缩骨架收缩的丝以及用于将收缩骨架锚定在心脏组织上的固定元件，所述丝包括控制部和连接部，所述连接部与所述收缩骨架连接，所述控制部设置在所述收缩骨架的两个端部之间，并且，操作所述控制部使得所述连接部拉动所述收缩骨架收缩，其中，在所述收缩骨架植入后，所述第一收缩件和第二收缩件相邻的一端分别设置在所述支撑骨架的两端处。The technical solution adopted to solve the technical problems of the present invention is: a heart valve forming system, which includes a shrinking skeleton, a covering layer covering the shrinking skeleton, a wire for controlling the contraction of the shrinking skeleton, and a wire for anchoring the shrinking skeleton in the heart. A fixation element on the tissue, the wire includes a control part and a connection part, the connection part is connected to the shrinkage frame, the control part is disposed between two ends of the shrinkage frame, and, operates the The control part causes the connecting part to pull the shrinkage frame to shrink, wherein, after the shrinkage frame is implanted, adjacent ends of the first shrinkage member and the second shrinkage member are respectively disposed at both ends of the support frame. at.
作为本发明的进一步改进，所述第一收缩件和第二收缩件分别设置有用于控制收缩的丝，并且，所述的丝呈闭环结构；所述第一收缩件和第二收缩件锚定在瓣环上后，通过拧所述控制部，使得所述连接部带动所述第一收缩件和第二收缩件实现收缩。As a further improvement of the present invention, the first shrinking member and the second shrinking member are respectively provided with wires for controlling shrinkage, and the wires are in a closed-loop structure; the first shrinking member and the second shrinking member are anchored After being on the valve annulus, by twisting the control part, the connecting part drives the first contraction part and the second contraction part to achieve contraction.
作为本发明的进一步改进，所述丝的连接部沿着所述第一收缩件或第二收缩件的边缘与所述第一收缩件或第二收缩件固定；沿着边缘一周固定，可以使得所述丝在拉动所述第一收缩件或第二收缩件时受力点更多、更均匀。As a further improvement of the present invention, the connecting part of the wire is fixed with the first shrinking part or the second shrinking part along the edge of the first shrinking part or the second shrinking part; fixed along the edge, it can make When the wire pulls the first shrinking member or the second shrinking member, the stress points are more uniform and more uniform.
作为本发明的进一步改进，所述控制部距离所述第一收缩件和第二收缩件相邻端部的长度占所述第一收缩件或第二收缩件横向长度的三分之二。As a further improvement of the present invention, the length of the control portion from the adjacent ends of the first shrinking member and the second shrinking member accounts for two-thirds of the transverse length of the first shrinking member or the second shrinking member.
作为本发明的进一步改进，所述第一收缩件和第二收缩件均包括前收缩部和后收缩部，并且，所述控制部被设置在所述前收缩部和后收缩部的交界处并且，操作所述控制部使得所述第一收缩件和第二收缩件在收缩后，所述后收缩部收缩的行程大于所述前收缩部收缩的行程；这使得后瓣的P2区明显地向瓣膜中心移动，而前瓣区域是小幅度向瓣膜中心移动，既能有效增加瓣叶之间的对合面积，又能避免因前瓣区域移动幅度过大导致主动脉血流供应出现问题。As a further improvement of the present invention, the first contraction part and the second contraction part each include a front contraction part and a rear contraction part, and the control part is provided at the interface of the front contraction part and the rear contraction part, and , operate the control part so that after the first contraction part and the second contraction part contract, the contraction stroke of the rear contraction part is greater than the contraction stroke of the front contraction part; this makes the P2 area of the posterior flap obviously move toward The center of the valve moves, while the anterior valve area moves to the center of the valve to a small extent, which can not only effectively increase the area of apposition between the valve leaflets, but also avoid aortic blood flow supply problems caused by excessive movement of the anterior valve area.
作为本发明的进一步改进，所述前收缩部的刚度大于所述后收缩部的刚度，以使得所述第一收缩件或第二收缩件在收缩后，所述后收缩部向瓣膜中心摆动的幅度大于所述前收缩部向瓣膜中心摆动的幅度。As a further improvement of the present invention, the stiffness of the front contraction part is greater than the stiffness of the rear contraction part, so that after the first contraction part or the second contraction part contracts, the rear contraction part swings toward the center of the valve. The amplitude is greater than the amplitude of the swing of the front constriction part toward the center of the valve.
作为本发明的进一步改进，还包括支撑骨架，所述支撑骨架为开环结构，其中，所述支撑骨架分别与所述第一收缩件和第二收缩件连接，并且，所述第一收缩件和第二收缩件相邻的一端分别设置在所述支撑骨架的两端处。As a further improvement of the present invention, it also includes a support frame, which is an open-loop structure, wherein the support frame is connected to the first shrinking member and the second shrinking member respectively, and the first shrinking member One end adjacent to the second shrinking member is respectively provided at both ends of the support frame.
作为本发明的进一步改进，所述支撑骨架由若干个呈“Ω”形态的支撑单元组成，并且，自体瓣环各区域对应的支撑单元的刚度不同，其中，位于设定的缩环区域的支撑单元的刚度要小于瓣叶交界处的支撑单元的刚度。As a further improvement of the present invention, the support skeleton is composed of several support units in the shape of "Ω", and the support units corresponding to each area of the autologous valve annulus have different stiffnesses, wherein the supports located in the set contraction ring area The stiffness of the unit is smaller than the stiffness of the support unit at the junction of the leaflets.
作为本发明的进一步改进，在前收缩部区域至少锚定有一个固定元件，在后收缩部区域至少锚定有两个固定元件。As a further improvement of the invention, at least one fixing element is anchored in the front constriction area, and at least two fixing elements are anchored in the rear constriction area.
作为本发明的进一步改进，所述覆盖层为织物，并且，所述覆盖层为适配于瓣环形态的闭环结构；这使得在植入时，可直接将整个环扣在自体瓣环上，无需过度依赖影像来定位。As a further improvement of the present invention, the covering layer is fabric, and the covering layer is a closed ring structure adapted to the shape of the annulus; this allows the entire ring to be directly buckled on the autologous annulus during implantation, No need to rely too much on images for positioning.
作为本发明的进一步改进，在用于二尖瓣治疗时，所述设定的缩环区域位于自体瓣环的P2区，而第一收缩件和第二收缩件相邻的一端是设置在自体瓣环的P2区，使其在收缩时，P2区会显著地向瓣膜中心移动，从而带动后瓣叶向前瓣叶贴靠，增加瓣叶之间的对合面积，从而有效治疗反流。As a further improvement of the present invention, when used for mitral valve treatment, the set shrinking ring area is located in the P2 area of the autologous valve annulus, and the adjacent ends of the first shrinking member and the second shrinking member are set in the autologous valve annulus. The P2 area of the valve annulus causes the P2 area to move significantly toward the center of the valve when it contracts, thereby driving the posterior valve leaflets to lean against the forward valve leaflets, increasing the area of convergence between the valve leaflets, thereby effectively treating regurgitation.
与现有技术相比，本申请的优点和有益技术效果至少包含以下所列：Compared with the existing technology, the advantages and beneficial technical effects of this application include at least the following:
1.现有技术中，成形术装置在收缩时，虽然能将自体瓣环的P2区域明显向瓣膜中心靠拢，但由于力的相互作用，也导致前瓣环区域过度向瓣膜中心移动，虽然能增加自体瓣叶的对合面积，但是前瓣叶的过度牵拉势必会影响主动脉瓣膜，引起并发症；因此，在本申请的一实施例中，控制部是距离第一收缩件和第二收缩件相邻端部的长度占第一收缩件或第二收缩件横向长度的三分之二，这使得第一收缩件或第二收缩件在收缩时，其局部收缩的幅度有差异，使得瓣环的P2区向瓣膜中心移动的幅度要显著大于前瓣区域向瓣膜中心移动的幅度，这既能有效增加瓣叶之间的对合面积，减少瓣膜反流，又能避免前瓣区域过度移动，对主动脉瓣膜造成影响，有效减少术后并发症，具有很好的临床意义。1. In the existing technology, when the arthroplasty device contracts, although it can obviously move the P2 area of the autologous valve annulus closer to the valve center, due to the interaction of forces, it also causes the anterior annulus area to move excessively toward the valve center. Although it can Increase the apposition area of the native valve leaflets, but excessive pulling of the anterior valve leaflets will inevitably affect the aortic valve and cause complications; therefore, in one embodiment of the present application, the control part is located at a distance from the first contraction member and the second contraction member. The length of the adjacent ends of the shrinking member accounts for two-thirds of the transverse length of the first shrinking member or the second shrinking member, which makes the first shrinking member or the second shrinking member have a difference in local shrinkage amplitude when shrinking, so that The P2 area of the valve annulus moves toward the valve center to a significantly greater extent than the anterior valve area moves toward the valve center. This can not only effectively increase the area of apposition between valve leaflets, reduce valve regurgitation, but also avoid excessive anterior valve area. Movement affects the aortic valve and effectively reduces postoperative complications, which has good clinical significance.
2.区别于现有技术，在本申请的一实施例中，设置支撑骨架，该支撑骨架为开环结构，并且第一收缩件和第二收缩件相邻的一端分别设置在支撑骨架的两端处，又由于第一收缩件和第二收缩件相邻的一端设置在设定的缩环区域，使其在收缩成形时，设定的缩环区域部分（即P2区域）会明显向瓣膜中心靠拢，而前瓣环区域由于支撑骨架提供的力能抵消部分缩环构件收缩的力，使得前瓣环区域向瓣膜中心移动的距离不大，从而有效避免对主动脉瓣膜造成的影响，同时，房室瓣瓣环成形装置为整环结构，使其在植入时无需过度依赖影像来定位，并且，整环结构有利于后续置换治疗时，支架的锚固，具有很好的临床意义。2. Different from the prior art, in one embodiment of the present application, a support frame is provided. The support frame has an open-loop structure, and the adjacent ends of the first shrinkage member and the second shrinkage member are respectively provided on both sides of the support frame. end, and because the adjacent end of the first shrinking member and the second shrinking member is set in the set shrinking ring area, when shrinking and forming, the set shrinking ring area part (i.e. P2 area) will obviously move towards the valve. The center of the annulus is close together, and the force provided by the supporting skeleton in the anterior annulus can offset the shrinkage force of part of the shrinking annulus components, so that the anterior annulus does not move far toward the center of the valve, thereby effectively avoiding the impact on the aortic valve, and at the same time The atrioventricular annuloplasty device has a whole-ring structure, so that it does not need to rely too much on images for positioning during implantation. Moreover, the whole-ring structure is conducive to the anchoring of the stent during subsequent replacement treatment, which has good clinical significance.
3.区别于现有技术，本申请的一实施例中，支架骨架由若干个支撑单元组成，并且，不同区域的支撑单元刚度不是一致的，例如，位于设定的缩环区域的支撑单元的刚度要小于瓣叶交界处的支撑单元的刚度，这使得该缩环构件在收缩后是非均匀收缩的，其设定的缩环区域（即P2区域）收缩的距离要大于前瓣环区域收缩的距离，避免因前瓣环移动距离过大影响主动脉瓣膜的血流供应。3. Different from the prior art, in one embodiment of the present application, the stent skeleton is composed of several support units, and the stiffness of the support units in different areas is not consistent. For example, the support units located in the set shrink ring area The stiffness is smaller than the stiffness of the support unit at the junction of the valve leaflets, which causes the shrinking ring component to shrink non-uniformly after contraction. The shrinking distance of the set shrinking ring area (i.e. P2 area) is greater than the contraction distance of the anterior annulus area. distance to avoid affecting the blood flow supply of the aortic valve due to excessive movement of the anterior valve annulus.
本申请的实施例可实现其它未一一列出的有益技术效果，这些其它的技术效果在下文中可能有部分描述，并且对于本领域的技术人员而言在阅读了本申请后是可以预期和理解的。Embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. of.
附图说明Description of drawings
通过参考下文的描述连同附图，这些实施例的上述特征和优点及其他特征和优点以及实现它们的方式将更显而易见，并且可以更好地理解本申请的实施例，在附图中：The above-described features and advantages and other features and advantages of these embodiments, as well as the manner of achieving them, will be more apparent, and embodiments of the present application may be better understood, by referring to the following description in conjunction with the accompanying drawings, in which:
图1a～1d为本发明收缩瓣环的装置的结构示意图，其中图1d为丝的形态示意图。Figures 1a to 1d are schematic structural diagrams of the device for contracting the annulus of the present invention, wherein Figure 1d is a schematic diagram of the shape of the wire.
图2a～2d为本发明心脏瓣膜成形系统在二尖瓣瓣环上进行收缩的过程示意图，其中2b为未拧紧控制丝时收紧瓣环的装置在二尖瓣瓣环上的示意图，图2d为拧紧控制丝后收紧瓣环的装置在二尖瓣瓣环上的示意图。Figures 2a to 2d are schematic diagrams of the process of contraction of the mitral valve annulus by the heart valvuloplasty system of the present invention, wherein 2b is a schematic diagram of the device for tightening the annulus on the mitral valve annulus when the control wire is not tightened, Figure 2d Schematic diagram of the annulus-tightening device on the mitral valve annulus after tightening the control wire.
附图中各数字所指代的部位名称如下：1-收缩骨架，11-第一收缩件，12-第二收缩件，13-前收缩部，14-后收缩部，2-覆盖层，3-丝，31-控制部，32-连接部，4-固定元件，5-支撑骨架，51-支撑单元。The names of the parts designated by the numbers in the drawings are as follows: 1-shrinking frame, 11-first shrinking part, 12-second shrinking part, 13-front shrinking part, 14-rear shrinking part, 2-covering layer, 3 -Wire, 31-control part, 32-connection part, 4-fixing element, 5-support frame, 51-support unit.
实施方式Implementation
在以下对附图和具体实施方式的描述中，将阐述本申请的一个或多个实施例的细节。从这些描述、附图以及权利要求中，可以清楚本申请的其它特征、目的和优点。The details of one or more embodiments of the application are set forth in the following description of the drawings and the detailed description. Other features, objects, and advantages of the present application will be apparent from the description, drawings, and claims.
应当理解，所图示和描述的实施例在应用中不限于在以下描述中阐明或在附图中图示的构件的构造和布置的细节。所图示的实施例可以是其它的实施例，并且能够以各种方式来实施或执行。各示例通过对所公开的实施例进行解释而非限制的方式来提供。实际上，将对本领域技术人员显而易见的是，在不背离本申请公开的范围或实质的情况下，可以对本申请的各实施例作出各种修改和变型。例如，作为一个实施例的一部分而图示或描述的特征，可以与另一实施例一起使用，以仍然产生另外的实施例。因此，本申请公开涵盖属于所附权利要求及其等同要素范围内的这样的修改和变型。It is to be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments are capable of other embodiments and of being practiced or carried out in various ways. Each example is provided by way of explanation of the disclosed embodiments, not limitation. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce further embodiments. This disclosure is therefore intended to cover such modifications and variations as come within the scope of the appended claims and their equivalents.
同样，可以理解，本文中所使用的词组和用语是出于描述的目的，而不应当被认为是限制性的。本文中的“包括”、“包含”或“具有”及其变型的使用，旨在开放式地包括其后列出的项及其等同项，以及可能的附加项。Likewise, it is to be understood that the phrases and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "including," "including," or "having" and variations thereof herein is intended to include the items listed thereafter and their equivalents, as well as possible additional items, in an open-ended manner.
下面将参考本申请的若干方面的不同的实施例和示例对本申请进行更详细的描述。The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.
本申请中，近端是指接近手术操作者的一端，远端是指远离手术操作者的一端。In this application, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator.
在现有技术中，针对房室瓣瓣膜置换的过程中自体瓣膜通常都不能正常工作，而这种传统的治疗手段会导致整个瓣膜在置换的过程中都处于开口反流的状态，导致手术时间非常短促且风险较高，并可能引发各种病症。In the existing technology, during the process of atrioventricular valve replacement, the autologous valve usually cannot work normally, and this traditional treatment method will cause the entire valve to be in a state of regurgitation during the replacement process, resulting in long operation time. It is very short-lived and high-risk, and can cause various illnesses.
实施例Example
如图1a～1d所示，一种心脏瓣膜成形系统，包括用于收缩自体瓣环的装置和用于将装置输送至心内的输送器，该装置包括收缩骨架1、覆在收缩骨架1上的覆盖层2、用于控制收缩骨架1收缩的丝3、用于将收缩骨架1锚定在心脏组织上的固定元件4，其中，所述收缩骨架1包括第一收缩件11和第二收缩件12，所述第一收缩件11和第二收缩件12分别设置有用于控制收缩的丝3，并且，所述的丝3包括分为控制部31和连接部32，其连接部32是指与第一收缩件11或第二收缩件12连接的部分，控制部31是用于操作以使得收缩件实现收缩的部位，所述的收缩骨架1经输送器输送至心内的目标位置后（自体瓣环处），利用固定元件4将收缩骨架1锚定在自体瓣环上，此时，第一收缩件11和第二收缩件12相邻的一端位于自体瓣环的P2区（即设定的缩环区域），如图2b所示，随后通过拧所述的控制部31使得连接部32带动第一收缩件11和第二收缩件2收缩，进一步带动自体瓣环实现紧缩，如图2c和2d所示，而控制部31是距离所述第一收缩件11和第二收缩件12相邻端部的长度占所述第一收缩件11或第二收缩件2横向长度的三分之二，如图1b所示，因此，自体瓣环P2区部分向瓣膜中心移动的距离要大于前瓣区域向瓣膜中心移动的距离，这既能有效增加瓣叶之间的对合面积，减少瓣膜反流，又能避免前瓣区域过度移动，对主动脉瓣膜造成影响，有效减少术后并发症，具有很好的临床意义。As shown in Figures 1a to 1d, a cardiac valvuloplasty system includes a device for contracting the autogenous valve annulus and a transporter for transporting the device into the heart. The covering layer 2, the wire 3 used to control the contraction of the contraction skeleton 1, and the fixing element 4 used to anchor the contraction skeleton 1 to the heart tissue, wherein the contraction skeleton 1 includes a first contraction part 11 and a second contraction part. 12, the first shrinking member 11 and the second shrinking member 12 are respectively provided with wires 3 for controlling shrinkage, and the wires 3 include a control part 31 and a connecting part 32, and the connecting part 32 refers to The control part 31 is the part connected to the first shrinking member 11 or the second shrinking member 12, which is used to operate the shrinking member to achieve contraction. After the shrinking skeleton 1 is transported to the target position in the heart via the conveyor ( (at the autologous valve annulus), use the fixing element 4 to anchor the shrinkable skeleton 1 on the autologous valve annulus. At this time, the adjacent ends of the first shrinkable member 11 and the second shrinkable member 12 are located in the P2 area of the autologous valve annulus (that is, assuming (a certain shrinking ring area), as shown in Figure 2b, and then by twisting the control part 31, the connecting part 32 drives the first shrinking part 11 and the second shrinking part 2 to shrink, further driving the autologous valve annulus to achieve shrinkage, as shown in Figure 2c and 2d, and the length of the control portion 31 from the adjacent ends of the first shrinking member 11 and the second shrinking member 12 accounts for three thirds of the lateral length of the first shrinking member 11 or the second shrinking member 2 Second, as shown in Figure 1b, therefore, the distance that the P2 area of the autologous annulus moves to the valve center is greater than the distance that the anterior valve area moves to the valve center. This can not only effectively increase the area of overlap between the valve leaflets, but also reduce Valvular regurgitation can also prevent excessive movement of the anterior valve area and affect the aortic valve, effectively reducing postoperative complications, which has good clinical significance.
在本实施例中，所述的丝3呈闭环结构，如图1d所示，输送器设有与丝3拆卸连接的控制杆，通过转动控制杆来拧紧，使得丝3逐步缩紧，进一步带动收缩骨架1、自体瓣环实现紧缩，完成缩环。In this embodiment, the wire 3 has a closed-loop structure, as shown in Figure 1d. The conveyor is provided with a control rod that is detachably connected to the wire 3. The control rod is rotated to tighten, so that the wire 3 gradually tightens, further driving the Shrinking the skeleton 1. The autogenous valve annulus is tightened to complete the annulus contraction.
在本实施例中，所述丝3的连接部32沿着所述第一收缩件11或第二收缩件2的边缘与所述第一收缩件11或第二收缩件2固定；沿着边缘一周固定，可以使得所述丝3在拉动所述第一收缩件11或第二收缩件2时受力点更多、更均匀。In this embodiment, the connecting portion 32 of the wire 3 is fixed to the first shrinking member 11 or the second shrinking member 2 along the edge of the first shrinking member 11 or the second shrinking member 2; along the edge Fixing for one week can make the wire 3 receive more and more uniform stress points when pulling the first shrinking member 11 or the second shrinking member 2 .
在本实施例中，所述第一收缩件11和第二收缩件2均包括前收缩部13和后收缩部14，并且，所述控制部31被设置在所述前收缩部13和后收缩部14的交界处，如图1a和1b所示，并且，操作所述控制部31使得所述第一收缩件11和第二收缩件2在收缩后，所述后收缩部14收缩的行程大于所述前收缩部13收缩的行程，如图2c和2d所示；这使得后瓣的P2区明显地向瓣膜中心移动，而前瓣区域是小幅度向瓣膜中心移动，既能有效增加瓣叶之间的对合面积，又能避免因前瓣区域移动幅度过大导致主动脉血流供应出现问题。In this embodiment, the first contraction part 11 and the second contraction part 2 both include a front contraction part 13 and a rear contraction part 14, and the control part 31 is disposed between the front contraction part 13 and the rear contraction part 14. 1a and 1b, and the control part 31 is operated so that after the first contraction part 11 and the second contraction part 2 are contracted, the contraction stroke of the rear contraction part 14 is greater than The contraction stroke of the front constriction part 13 is shown in Figures 2c and 2d; this makes the P2 area of the posterior valve obviously move toward the center of the valve, while the front valve area moves slightly towards the center of the valve, which can effectively increase the number of valve leaflets. The overlapping area between them can also avoid aortic blood flow supply problems caused by excessive movement of the anterior valve area.
在本实施例中，所述前收缩部13的刚度大于所述后收缩部14的刚度，以使得所述第一收缩件11或第二收缩件2在收缩后，所述后收缩部14向瓣膜中心摆动的幅度大于所述前收缩部13向瓣膜中心摆动的幅度。In this embodiment, the stiffness of the front contraction part 13 is greater than the stiffness of the rear contraction part 14, so that after the first contraction part 11 or the second contraction part 2 contracts, the rear contraction part 14 moves toward The swing amplitude of the valve center is greater than the swing amplitude of the front constriction portion 13 toward the valve center.
在本实施例中，所述支撑骨架5由若干个呈“Ω”形态的支撑单元51组成，如图1c所示，并且，自体瓣环各区域对应的支撑单元51的刚度不同，其中，位于设定的缩环区域的支撑单元51的刚度要小于瓣叶交界处的支撑单元51的刚度。In this embodiment, the support skeleton 5 is composed of several support units 51 in the shape of "Ω", as shown in Figure 1c, and the support units 51 corresponding to each area of the autologous valve annulus have different stiffnesses, where The stiffness of the support unit 51 in the contracted ring region is set to be smaller than the stiffness of the support unit 51 at the junction of the leaflets.
在本实施例中，在前收缩部13区域至少锚定有一个固定元件4，在后收缩部14区域至少锚定有两个固定元件4。In this embodiment, at least one fixing element 4 is anchored in the area of the front constriction 13 , and at least two fixing elements 4 are anchored in the area of the rear constriction 14 .
在本实施例中，所述覆盖层2为织物，并且，所述覆盖层2为适配于瓣环形态的闭环结构；这使得在植入时，可直接将整个环扣在自体瓣环上，无需过度依赖影像来定位。In this embodiment, the covering layer 2 is made of fabric, and the covering layer 2 is a closed-ring structure adapted to the shape of the valve annulus; this allows the entire ring to be directly buckled on the autologous valve annulus during implantation , no need to rely too much on images for positioning.
本实施例一的一种心脏瓣膜成形系统的一个示范性的修复二尖瓣瓣膜的操作过程如下：An exemplary operation process of repairing the mitral valve of the heart valvuloplasty system of the first embodiment is as follows:
1.操作输送系统使其由上腔静脉进入至右心房，然后穿过房间隔抵达左心房；1. Operate the delivery system to enter the right atrium from the superior vena cava, and then pass through the interatrial septum to the left atrium;
2.将用于收紧瓣环的装置从输送器内释放，此时，该装置呈环形结构并将其覆盖在自体瓣环组织上，进一步操作输送系统使其固定元件4输出并穿过织物层将装置锚定在自体瓣环上，如图2a和2b所示；2. Release the device for tightening the annulus from the delivery device. At this time, the device assumes a ring-shaped structure and covers it on the autologous annulus tissue. Further operate the delivery system to output the fixing element 4 and pass through the fabric. The layer anchors the device to the native valve annulus, as shown in Figures 2a and 2b;
3. 拧紧控制收缩的丝3，使得第一收缩件11和第二收缩件2收缩瓣环，如图2c和2d所示，通过影像观察，当第一收缩件11和第二收缩件2收缩至适当位置时，输送器与丝3拆卸并撤离输送系统，完成手术。3. Tighten the contraction control wire 3 so that the first contraction part 11 and the second contraction part 2 contract the annulus, as shown in Figures 2c and 2d. Through image observation, when the first contraction part 11 and the second contraction part 2 contract When reaching the appropriate position, the conveyor and wire 3 are disassembled and evacuated from the delivery system to complete the operation.
本发明产品不仅适用于修复二尖瓣瓣膜疾病，同样也适用于三尖瓣瓣膜疾病。The product of the invention is not only suitable for repairing mitral valve diseases, but is also suitable for tricuspid valve diseases.
最后，应当说明的是，以上所述仅为本发明的较优的实施例而已，并不以此限制本发明，凡在本发明的精神和原则之内的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。Finally, it should be noted that the above are only preferred embodiments of the present invention and do not limit the present invention. Any modifications, equivalent substitutions and improvements within the spirit and principles of the present invention, etc. All should be included in the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211466042 | 2022-11-22 | ||
| CN2022114660425 | 2022-11-22 |
| Publication Number | Publication Date |
|---|---|
| CN117598838Atrue CN117598838A (en) | 2024-02-27 |
| CN117598838B CN117598838B (en) | 2025-06-24 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311517720.0AActiveCN117598838B (en) | 2022-11-22 | 2023-11-15 | Heart valve forming system |
| Country | Link |
|---|---|
| CN (1) | CN117598838B (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
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| US6187040B1 (en)* | 1999-05-03 | 2001-02-13 | John T. M. Wright | Mitral and tricuspid annuloplasty rings |
| US20020183836A1 (en)* | 2001-02-05 | 2002-12-05 | Liddicoat John R. | Apparatus and method for reducing mitral regurgitation |
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| CN115105265A (en)* | 2022-08-04 | 2022-09-27 | 浙江大学医学院附属第一医院 | A repair device that prevents mitral regurgitation |
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| US6187040B1 (en)* | 1999-05-03 | 2001-02-13 | John T. M. Wright | Mitral and tricuspid annuloplasty rings |
| US20020183836A1 (en)* | 2001-02-05 | 2002-12-05 | Liddicoat John R. | Apparatus and method for reducing mitral regurgitation |
| US20070027533A1 (en)* | 2005-07-28 | 2007-02-01 | Medtronic Vascular, Inc. | Cardiac valve annulus restraining device |
| US20190336288A1 (en)* | 2006-12-05 | 2019-11-07 | Valtech Cardio, Ltd. | Implantation of repair devices in the heart |
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