技术领域Technical field
本发明涉及管腔内可植入式医疗器械技术领域，特别是涉及经介入术植入管腔的医疗器械，例如封堵装置。The present invention relates to the technical field of intraluminal implantable medical devices, and in particular to medical devices implanted into the lumen through interventional procedures, such as blocking devices.
背景技术Background technique
申请人在先的公开号为WO2017114348A的PCT专利公开了一种左心耳封堵器，将WO2017114348A全文引入本申请中，该左心耳封堵器可经输送导管系统于受试者体外向左心耳在血管腔道中建立的输送通路，而被输送至左心耳内行封堵术，以预防患者发生房颤可能造成的卒中等风险发生。该封堵器包括锚定盘和封堵盘，本申请图14给出了一种该封堵器的示例，其中作为固定部件101的锚定盘可为镍钛金属管切割的多根杆构件102构成，杆构件102的一端汇集于管状的中心件103，另一端为自由端，且自由端侧多根杆构件交叉排布成具有弹性的盘形结构。锚定盘的弹性盘形结构可受左心耳内腔壁压迫束缚而使得封堵器固定于左心耳，与锚定盘相连接的作为密封部件201的封堵盘被定位于左心耳口处并封闭左心耳，即左心房与左心耳被封堵盘所隔离，可参见本申请图15。The applicant's previous PCT patent with publication number WO2017114348A discloses a left atrial appendage occluder. The full text of WO2017114348A is incorporated into this application. The left atrial appendage occluder can be delivered to the left atrial appendage outside the subject's body through a delivery catheter system. The delivery pathway established in the vascular lumen is delivered to the left atrial appendage for closure to prevent the risk of stroke and other risks that may be caused by atrial fibrillation in patients. The occluder includes an anchoring disk and a blocking disk. Figure 14 of this application shows an example of the occluder. The anchoring disk as the fixing component 101 can be a plurality of rod members cut from nickel-titanium metal tubes. 102, one end of the rod member 102 is gathered into the tubular central piece 103, the other end is a free end, and multiple rod members on the free end side are arranged crosswise into an elastic disk-shaped structure. The elastic disc-shaped structure of the anchoring disc can be compressed and restrained by the inner wall of the left atrial appendage so that the occluder is fixed to the left atrial appendage. The occluder disc as the sealing component 201 connected to the anchoring disc is positioned at the left atrial appendage orifice and The left atrial appendage is closed, that is, the left atrium and the left atrial appendage are isolated by the occluding disk, as shown in Figure 15 of this application.
其中，为满足导管内输送，锚定盘需要具有足够的弹性而可被压缩至极小直径，并且，锚定盘经导管输送向左心耳内释放后必需能够扩展恢复至所需的较大直径的盘形锚定结构，构成盘形结构的多根杆构件在交叉排布时保留单个杆构件的适当的活动空间是希望的，这种活动可以理解为杆的自由端朝向任意方向的移动而导致的杆构件的弹性形变。然而过于松散的交叉排布可能使得相邻杆构件具有不期望的较大的相对活动空间，这将可能使得盘形锚定结构具有弱的维持盘形的能力，从而导致锚定盘在左心耳内的定位能力下降或不足。Among them, in order to meet the requirements of intracatheter delivery, the anchoring disc needs to be elastic enough to be compressed to a very small diameter, and the anchoring disc must be able to expand and return to the required larger diameter after being delivered into the left atrial appendage through the catheter. For a disc-shaped anchoring structure, it is desirable to retain an appropriate space for movement of a single bar member when the multiple rod members constituting the disc-shaped structure are arranged in a crosswise manner. This kind of movement can be understood as caused by the movement of the free end of the rod in any direction. elastic deformation of the rod member. However, too loose cross-arrangement may cause adjacent rod members to have an undesirably large relative movement space, which may cause the disc-shaped anchoring structure to have a weak ability to maintain the disc shape, resulting in the anchoring disc being in the left atrial appendage. The internal positioning ability is reduced or insufficient.
发明内容Contents of the invention
本发明的一个目的是提供一种固定部件，用于植入式医疗器械，其构成植入式医疗器械的一部分，起到在所植入部位定位所述医疗器械的功能。所植入部位可以是一种器官或组织的内腔或者管腔，例如左心耳、血管腔等，但不限于此。An object of the present invention is to provide a fixing component for an implantable medical device, which constitutes a part of the implanted medical device and has the function of positioning the medical device at the implanted site. The implanted site may be the lumen or lumen of an organ or tissue, such as the left atrial appendage, vascular cavity, etc., but is not limited thereto.
本发明的另一个目的是提供一种前述固定部件的制备方法。Another object of the present invention is to provide a method for preparing the aforementioned fixing component.
本发明的再一个目的是提供一种含有前述固定部件的植入式医疗器械及其制备方法。Another object of the present invention is to provide an implantable medical device containing the aforementioned fixing component and a preparation method thereof.
本发明的又一个目的是提供一种含有前述固定部件的封堵装置，特别是一种左心耳封堵器。封堵装置还包括与所述固定部件相连接的密封部件，用于实现对所植入部位的封堵，例如对器官或组织的内腔或者管腔的封堵或密封，以限制血流等的通过。Another object of the present invention is to provide an occlusion device containing the aforementioned fixing component, especially a left atrial appendage occlusion device. The blocking device also includes a sealing component connected to the fixed component for blocking the implanted site, such as blocking or sealing the inner cavity or lumen of an organ or tissue to limit blood flow, etc. passed.
本发明的可用于植入式医疗器械的固定部件的一个实施例中，所述固定部件可弹性压缩而具有可变的直径，所述固定部件包括中心管件和由所述中心管件一端向外分出的环形排布的多个支撑杆，其中，所述多个支撑杆先在所述中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成所述固定部件的径向外缘，至少一个支撑杆具有基本横跨过所述管口的横直段，并在所述横直段处与其它支撑杆形成所述交叉排列。In one embodiment of the fixing component of the present invention that can be used for implantable medical devices, the fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and two branches extending outward from one end of the central tube. A plurality of support rods are arranged in an annular shape, wherein the plurality of support rods are first gathered on the side outside the nozzle of the central pipe member to form a cross arrangement, and then extended to the surroundings respectively to form the radial outer direction of the fixed component. rim, at least one support rod has a transverse straight section that substantially spans the pipe opening, and forms the cross arrangement with other support poles at the transverse straight section.
本发明的可用于植入式医疗器械的固定部件的一个实施例中，所述固定部件可弹性压缩而具有可变的直径，所述固定部件包括中心管件和由所述中心管件一端向外分出的环形排布的多个支撑杆，其中，所述多个支撑杆均先跨过所述中心管件的管口并由此在所述中心管件的外侧形成交叉排列，再分别向四周延伸形成所述固定部件的径向外缘，其中，所述多个支撑杆按其环形排布位置以错位排序或以非顺序方式依次跨过所述中心管件的口形成所述交叉排列。In one embodiment of the fixing component of the present invention that can be used for implantable medical devices, the fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and two branches extending outward from one end of the central tube. A plurality of support rods are arranged in an annular shape, wherein the plurality of support rods first span the nozzle of the central pipe member and thereby form a cross arrangement on the outside of the central pipe member, and then extend to the surroundings respectively to form The radial outer edge of the fixed component, wherein the plurality of support rods are arranged in a staggered order according to their annular arrangement positions or in a non-sequential manner across the mouth of the central pipe to form the cross arrangement.
本发明的可用于植入式医疗器械的固定部件的一个实施例中，所述固定部件可弹性压缩而具有可变的直径，所述固定部件包括中心管件和由所述中心管件一端向外分出的环形排布的多个支撑杆，其中，所述多个支撑杆先在所述中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成所述固定部件的径向外缘，所述多个支撑杆的在交叉排列处的部分在空间分布形成直径接近所述中心管件的柱形部。In one embodiment of the fixing component of the present invention that can be used for implantable medical devices, the fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and two branches extending outward from one end of the central tube. A plurality of support rods are arranged in an annular shape, wherein the plurality of support rods are first gathered on the side outside the nozzle of the central pipe member to form a cross arrangement, and then extended to the surroundings respectively to form the radial outer direction of the fixed component. The portions of the plurality of support rods at the cross arrangement are spatially distributed to form a cylindrical portion with a diameter close to that of the central pipe.
本发明的可用于植入式医疗器械的固定部件的一个实施例中，所述固定部件可弹性压缩而具有可变的直径，所述固定部件包括中心管件和由所述中心管件一端向外分出的环形排布的多个支撑杆，所述多个支撑杆均跨过所述中心管件的管口向其各自的对侧方向延伸至各自的末端并形成所述固定部件的径向外缘，其中，所述支撑杆具有自所述中心管件引出的基本沿所述中心管件的轴向延伸的引出段，跨越所述管口的跨越段，以及继续向外延伸形成所述固定部件的径向外缘的外延段，所述引出段经第一弯曲过渡为跨越段，再经第二弯曲过渡为外延段。In one embodiment of the fixing component of the present invention that can be used for implantable medical devices, the fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and two branches extending outward from one end of the central tube. A plurality of supporting rods are arranged in an annular shape, and each of the supporting rods extends across the opening of the central pipe member to its respective opposite side direction to its respective end and forms the radial outer edge of the fixing component. , wherein the support rod has a lead-out section extending from the central pipe and extending substantially along the axial direction of the central pipe, a spanning section across the pipe opening, and a diameter that continues to extend outward to form the fixing component. As for the extension section toward the outer edge, the lead-out section transitions to a spanning section through a first bend, and then transitions into an extension section through a second bend.
上述不同实施例中的实施方式通常是可以任意结合的，以进一步获得更优选的固定部件的实施例。The implementations in the above different embodiments can generally be combined arbitrarily to further obtain a more preferred embodiment of the fixing component.
本发明的固定部件的一个实施例中，所述外延段包括轴向延伸的第一部分，以及斜向向外延伸的第二部分，所述跨越段经第二弯曲过渡为所述外延段的第一部分，再经第三弯曲过渡为所述外延段的第二部分。In one embodiment of the fixing component of the present invention, the extension section includes an axially extending first part and a second part that extends obliquely outward, and the spanning section transitions into a third part of the extension section through a second bend. One part is then transformed into the second part of the extension section through a third bend.
本发明的固定部件的一个实施例中，所述第二部分的长度远大于所述第一部分。In one embodiment of the fixing component of the present invention, the length of the second part is much longer than that of the first part.
本发明的固定部件的一个实施例中，所述外延段的长度远大于所述引出段和跨越段。In one embodiment of the fixing component of the present invention, the length of the extension section is much longer than the lead-out section and the spanning section.
上述所指远大于，通常可以是指大于3倍以上。例如，外延段的第一部分可以为0.2-1厘米，外延段的第二部分可以为3-15厘米。The above refers to much greater than, usually can refer to greater than 3 times. For example, the first part of the extension segment may be 0.2-1 cm, and the second part of the extension segment may be 3-15 cm.
本发明的固定部件的一个实施例中，所述支撑杆的宽度沿其长度方向具有变化，其中，所述支撑杆在跨越段的宽度小于在引出段和/或外延段的宽度，或者，所述支撑杆在跨越段和引出段的宽度均小于在所述外延段的最大宽度。支撑杆宽度的这种变化设置，对于提高固定部件构型的稳定性和安全性通常是有利的，因为宽度限制了杆构件的形变和活动，同时也有助于提高固定部件的径向支撑力，增强固定部件的固定能力。In one embodiment of the fixing component of the present invention, the width of the support rod changes along its length direction, wherein the width of the support rod at the spanning section is smaller than the width at the lead-out section and/or the extension section, or, the width of the support rod changes along its length direction. The width of the support rod in the spanning section and the lead-out section is smaller than the maximum width in the extension section. This change in the width of the support rod is usually beneficial to improving the stability and safety of the fixed component configuration, because the width limits the deformation and movement of the rod member, and also helps to improve the radial support force of the fixed component. Enhance the fixing ability of fixed parts.
本发明一个实施例还提供了前述的固定部件的制备方法，包括如下步骤：One embodiment of the present invention also provides a method for preparing the aforementioned fixed component, which includes the following steps:
将一个原料管件去除多余材料，得到在原料管件的管周上间隔分布有多个杆的中间体；Remove excess material from a raw pipe fitting to obtain an intermediate body with multiple rods spaced around the circumference of the raw pipe fitting;
将中间体的多个杆加工成所需要的形状并经热处理定型。The multiple rods of the intermediate body are processed into the required shape and shaped by heat treatment.
本发明还提供了一种植入式医疗器械的实施例，其含有前述的固定部件。The present invention also provides an embodiment of an implantable medical device, which contains the aforementioned fixing component.
本发明的植入式医疗器械的一个实施例中，所述固定部件位于所述植入式医疗器械长度方向的一端，并通过所述中心部件与所述植入式医疗器械的其它部分连接。In one embodiment of the implantable medical device of the present invention, the fixing component is located at one end of the implantable medical device in the length direction and is connected to other parts of the implantable medical device through the central component.
本发明还提供了一种封堵装置的实施例，其含有前述的固定部件。The present invention also provides an embodiment of a blocking device, which contains the aforementioned fixing component.
本发明的封堵装置的一个实施例中，还包括与所述固定部件连接的密封部件。In one embodiment of the blocking device of the present invention, it further includes a sealing component connected to the fixing component.
本发明的封堵装置的一个实施例中，还包括与所述固定部件相连接的可弹性压缩而具有可变直径的密封部件，所述密封部件位于所述固定部件一侧，所述密封部件在其一端与所述固定部件的中心管件连接。In one embodiment of the blocking device of the present invention, it also includes an elastically compressible sealing component with a variable diameter connected to the fixing component, the sealing component being located on one side of the fixing component, and the sealing component One end thereof is connected to the central pipe of the fixed component.
本发明的封堵装置的一个实施例中，所述密封部件在其一端通过连接件与所述固定部件的中心管件连接。In one embodiment of the blocking device of the present invention, the sealing component is connected at one end to the central pipe of the fixing component through a connecting piece.
本发明的封堵装置的一个实施例中，所述连接件可弹性变形，并在受密封部件和/或固定部件的牵拉时调节所述密封部件和固定部件之间的距离。In one embodiment of the blocking device of the present invention, the connecting member is elastically deformable and adjusts the distance between the sealing component and the fixing component when being pulled by the sealing component and/or the fixing component.
本发明的封堵装置的一个实施例中，所述的固定部件包括阻流膜，所述阻流膜依次连接并固定于各个支撑杆，所述阻流膜至少在固定部件的径向形成覆盖以阻隔流体通过固定部件。In one embodiment of the blocking device of the present invention, the fixed component includes a flow-blocking film, which is connected and fixed to each support rod in turn, and the flow-blocking film forms a covering at least in the radial direction of the fixed component. To prevent fluid from passing through fixed parts.
综上，本发明的固定部件的某些实施例，至少通过支撑杆的形状进一步限制支撑杆在交叉排列处的位置，缩减其活动空间，有助于提高固定部件结构的稳定性。To sum up, some embodiments of the fixing component of the present invention further limit the position of the supporting rods at the cross arrangement at least through the shape of the supporting rods, reduce their movement space, and help improve the stability of the fixing component structure.
本发明的固定部件的某些实施例，至少通过支撑杆的形状减少支撑杆根部的应力集中，提高其耐疲劳性，保障固定部件使用中的安全性。Some embodiments of the fixed component of the present invention reduce the stress concentration at the root of the support rod at least through the shape of the support rod, improve its fatigue resistance, and ensure the safety of the fixed component during use.
本发明的固定部件的某些实施例，至少通过支撑杆的形状配合相邻支撑杆的交叉限位，进一步减少形变或应力向支撑杆根部的传递，显著提高支撑杆的耐疲劳性，保障固定部件使用中的安全性。Some embodiments of the fixing component of the present invention further reduce the transmission of deformation or stress to the root of the support rod, significantly improve the fatigue resistance of the support rod, and ensure the fixation by at least matching the shape of the support rod with the cross-limiting position of adjacent support rods. Safety in use of components.
本发明的固定部件的某些实施例，至少通过支撑杆的交叉排列方式，改善多个支撑杆在固定部件内的空间分布，提高固定部件的在径向的各向同性和抗轴向倾斜能力，保障固定部件的定位效果。Some embodiments of the fixed component of the present invention improve the spatial distribution of multiple support rods within the fixed component and improve the radial isotropy and axial tilt resistance of the fixed component through at least the cross arrangement of the support rods. , to ensure the positioning effect of fixed parts.
附图说明Description of the drawings
下面结合附图,对本发明作进一步详细的说明。The present invention will be described in further detail below in conjunction with the accompanying drawings.
图1为固定部件的一个实施例的示意图；Figure 1 is a schematic diagram of an embodiment of a fixing component;
图2和图3为图1所示固定部件的支撑杆顺序交叉排列方式的简化示意图；Figures 2 and 3 are simplified schematic diagrams of the sequential cross arrangement of the support rods of the fixed component shown in Figure 1;
图4为图2所示交叉排列的九个支撑杆的仰视图；Figure 4 is a bottom view of the nine support rods arranged crosswise as shown in Figure 2;
图5为固定部件的另一个实施例的示意图；Figure 5 is a schematic diagram of another embodiment of the fixing component;
图6和图7为图5所示固定部件的支撑杆非顺序交叉排列方式的简化示意图；Figures 6 and 7 are simplified schematic diagrams of the non-sequential cross arrangement of the support rods of the fixed component shown in Figure 5;
图8为图6所示交叉排列的九个支撑杆的仰视图；Figure 8 is a bottom view of the nine support rods arranged crosswise as shown in Figure 6;
图9为图5所示固定部件实施例的左视图；Figure 9 is a left side view of the embodiment of the fixing component shown in Figure 5;
图10为图5所示固定部件实施例的仰视图；Figure 10 is a bottom view of the embodiment of the fixing component shown in Figure 5;
图11为图5所示固定部件实施例的俯视图；Figure 11 is a top view of the embodiment of the fixing component shown in Figure 5;
图12为封堵装置的一个实施例的示意图；Figure 12 is a schematic diagram of an embodiment of the blocking device;
图13为图12所示封堵装置的另一个角度的示意图；Figure 13 is a schematic diagram of the blocking device shown in Figure 12 from another angle;
图14为现有技术左心耳封堵器的一种结构示意图；Figure 14 is a structural schematic diagram of a prior art left atrial appendage occluder;
图15为一种左心耳封堵器植入并封闭左心耳的状态示意图；Figure 15 is a schematic diagram of a state in which a left atrial appendage occluder is implanted and closed;
图16示出了七个不同规格的固定部件实施例的压缩量和径向支撑力变化曲线，其中LA18表示原始直径为18厘米的规格的固定部件实施例，其余类推。Figure 16 shows the compression amount and radial support force change curves of seven fixed component embodiments with different specifications, where LA18 represents the fixed component embodiment with an original diameter of 18 cm, and the rest are analogous.
各附图中，对附图标记说明如下：In each drawing, the reference signs are explained as follows:
a、中心管件；b、支撑杆汇集交叉部；b1、空区；b2、密区；a, central pipe; b, support rod intersection; b1, empty area; b2, dense area;
1、2、3、4、5、6、7、8、9、各为一个支撑杆；1, 2, 3, 4, 5, 6, 7, 8, 9 are each a support rod;
11、61、引出段；12、62、跨越段；131、外延段的第一部分；132、外延段的第二部分；23、63、外延段；231、第一宽部；232、第二宽部；14、锚刺；15、球形末端；11. 61. Leading section; 12. 62. Spanning section; 131. The first part of the extension section; 132. The second part of the extension section; 23. 63. The extension section; 231. The first wide part; 232. The second width part; 14, anchor spine; 15, spherical end;
101、固定部件；201、密封部件。101. Fixed components; 201. Sealing components.
具体实施方式Detailed ways
下面结合附图和具体实施方式对本发明作进一步详细说明。The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.
本发明提供了固定部件的实施例，可用于植入式医疗器械，固定部件可构成植入式医疗器械的一部分，起到在所植入部位定位所述医疗器械的功能。所植入部位通常可以是一种器官或组织的内腔或者管腔，例如左心耳、血管腔等。例如，植入式医疗器械可经过介入手术输送至患者体腔，植入式医疗器械的部件通常具有较小的直径，或者可被弹性压缩至较小直径，因而可以收入输送鞘管内，并经鞘管沿患者的血管通路输送至植入部位。固定部件由鞘管释放出后可弹性展开而与植入部位的腔壁相抵，并因腔内壁的压迫或其自身径向张力而保持于腔内，从而实现植入式医疗器械在植入部位的定位。The present invention provides an embodiment of a fixing component, which can be used in an implantable medical device. The fixing component can form a part of the implanted medical device and serve the function of positioning the medical device at the implanted site. The implanted site can usually be the lumen or lumen of an organ or tissue, such as the left atrial appendage, vascular cavity, etc. For example, implantable medical devices can be delivered to the patient's body cavity through interventional procedures. The components of the implantable medical device usually have a smaller diameter, or can be elastically compressed to a smaller diameter, so that they can be received into the delivery sheath and passed through the sheath. The tube is delivered along the patient's vascular access to the implantation site. After the fixed component is released from the sheath, it can be elastically deployed to offset the cavity wall of the implantation site, and remain in the cavity due to the pressure of the cavity wall or its own radial tension, thereby enabling the implantable medical device to be placed at the implantation site. positioning.
植入式医疗器械可以是一种封堵装置，例如左心耳封堵器，固定部件可以被施放于左心耳腔内，实现左心耳封堵器在左心耳处的定位，从而使得具有封堵功能的部件实现对左心耳口处的封堵。The implantable medical device can be an occluding device, such as a left atrial appendage occluding device. The fixing component can be placed in the left atrial appendage cavity to position the left atrial appendage occluding device at the left atrial appendage, thereby having a occluding function. The components realize the sealing of the left atrial appendage orifice.
不限于此，封堵装置也可以是其它的腔封堵器，其使用固定部件在腔内定位。例如动脉导管未闭封堵器，固定部件被施放于未闭的动脉导管实现封堵器的定位，封堵器的封堵部件因此被定位于主动脉侧口实现对动脉导管的封闭。又例如，血管封堵器，其可以具有如前所述基本相似的原理，固定部件施放于血管内并实现定位。It is not limited to this, the blocking device can also be other cavity blocking devices, which use fixing components to be positioned in the cavity. For example, with a patent ductus arteriosus occluder, the fixing component is applied to the patent ductus arteriosus to position the occluder, and the blocking component of the occluder is positioned at the side port of the aorta to seal the ductus arteriosus. Another example is a blood vessel occluder, which can have a basically similar principle as mentioned above. The fixing component is placed in the blood vessel and positioned.
根据需要，封堵装置可以设计成为被长期的达到数年以上时间的植入，也可以是临时的例如几天时间左右的植入。Depending on the needs, the occlusion device can be designed to be implanted for a long period of time of more than several years, or it can be temporarily implanted for a few days, for example.
植入式医疗器械还可以是心室减容装置，固定部件可被施放于左心室内底部，与左心耳内腔壁径向相抵，从而将减容装置固定于左心室底部，并通过固定部件上方的屏障部件将左心室隔离为屏障部件上方和下方两个腔，仅保留上方腔实现心室功能，达到减容目的。The implantable medical device can also be a ventricular volume reduction device. The fixing component can be placed at the bottom of the left ventricle to radially offset against the inner wall of the left atrial appendage, thereby fixing the volume reducing device to the bottom of the left ventricle and passing above the fixing component. The barrier component isolates the left ventricle into two chambers above and below the barrier component, leaving only the upper chamber to achieve ventricular function and achieve volume reduction.
不限于上述说明，本领域技术人员可以根据需要将固定部件施用于特定功能的植入式医疗器械。Without being limited to the above description, those skilled in the art can apply fixing components to implantable medical devices with specific functions as needed.
固定部件通常是可弹性压缩而具有可变的直径，以在介入手术中施用，固定部件的弹性压缩特性主要是以构成其的支撑杆的形变或活动实现。以下对固定部件的一些实施例作详细说明。The fixation component is usually elastically compressible and has a variable diameter for use in interventional procedures. The elastic compression characteristics of the fixation component are mainly achieved by the deformation or movement of the support rod that constitutes it. Some embodiments of fixing components are described in detail below.
某些实施例中，固定部件包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆，其中，多个支撑杆先在中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成固定部件的径向外缘，至少一个支撑杆具有基本横跨过管口的横直段，并在横直段处与其它支撑杆形成交叉排列。In some embodiments, the fixing component includes a central pipe and a plurality of annularly arranged support rods branching out from one end of the central pipe, wherein the plurality of support rods first converge on one side outside the mouth of the central pipe to form a cross arrangement. Then, they are respectively extended around to form the radial outer edge of the fixed component. At least one support rod has a horizontal straight section that basically spans the pipe opening, and forms a cross arrangement with other support poles at the horizontal straight section.
可参考图1或图5，示出固定部件的两个具体实施例。其中，中心管件a一端向外分出的环形排布的多个支撑杆，其中，多个支撑杆先在中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成固定部件的径向外缘。可进一步参考图3，其简化示意出图1中固定部件的支撑杆形成交叉排列的情况，将支撑杆向四周延伸的主体部分省略，其中支撑杆1从中心管件a引出后，基本横跨过中心管件a的管口延伸，之后再继续远离中心管件a延伸。支撑杆1的基本横跨过管口的跨越段12为横直在多数情况下是有利的，例如相比于斜向跨过管口，横直的跨越段12具有更短的长度和占位空间，因而可以使支撑杆在交叉排列位置与其它支撑杆更紧密排列，多个支撑杆排列也可以实现更密集的堆叠，从而缩减多个支撑杆交叉排列形成的占位空间，这对于直径和体积较小的植入式医疗器械是非常重要的，因为体积较大的植入式医疗器械可能无法被有效收入输送鞘管中输送，或输送困难。Referring to Figure 1 or Figure 5, two specific embodiments of the fixing component are shown. Among them, one end of the central pipe a has a plurality of annularly arranged support rods branching out. The plurality of support rods are first gathered on the side outside the mouth of the central pipe to form a cross arrangement, and then are extended to the surroundings to form fixed components. Radial outer edge. Further reference can be made to Figure 3, which simplifies the cross arrangement of the support rods of the fixed components in Figure 1, and omits the main part of the support rods extending to the surroundings. After the support rod 1 is led out from the central pipe a, it basically spans The pipe opening of the central pipe a extends, and then continues to extend away from the central pipe a. It is advantageous in most cases that the spanning section 12 of the support rod 1 that basically spans the pipe opening is horizontal. For example, compared with diagonally spanning the pipe opening, the horizontal spanning section 12 has a shorter length and takes up less space. Therefore, the support rods can be arranged more closely with other support rods in the cross arrangement position, and the arrangement of multiple support rods can also achieve denser stacking, thus reducing the space occupied by the cross arrangement of multiple support rods, which is a problem for small diameter and volume. Small implantable medical devices are very important, because larger implantable medical devices may not be effectively received into the delivery sheath for delivery, or may be difficult to deliver.
横直的跨越段12的另一个重要作用，是提高了支撑杆的限位效果，可参考图1，固定部件在支撑杆汇集交叉部b形成各支撑杆在中心管件a的轴向的交叉排列，各支撑杆之后继续向四周延伸，分别形成固定部件的直径外缘，例如支撑杆的外延段的232部分。在植入部位，固定部件的外缘受腔内壁压迫，支撑杆受该压迫向固定部件内部形变和活动，过大的形变和活动可能导致固定部件的定位能力降低和轴向的移动，而横直的跨越段12的延伸方向与该受压迫方向相向，因而可以起到类似砥柱的作用，有效抵抗支撑杆外延段内移，配合各支撑杆间的交叉限位，使得固定部件的结构和位置保持稳固。Another important function of the horizontal spanning section 12 is to improve the limiting effect of the support rods. Refer to Figure 1. The fixed components are at the intersection b of the support rods to form an axial cross arrangement of the support rods in the central pipe a. Each support rod then continues to extend around, respectively forming the outer diameter edge of the fixed component, such as part 232 of the extension section of the support rod. At the implantation site, the outer edge of the fixed component is pressed by the inner wall of the cavity, and the support rod is deformed and moved inside the fixed component due to this pressure. Excessive deformation and movement may lead to a reduction in the positioning ability of the fixed component and axial movement. The extension direction of the spanning section 12 is opposite to the direction of compression, so it can play a role similar to a pillar, effectively resisting the inward movement of the extension section of the support rod, and cooperate with the cross limit between the support rods to fix the structure and position of the component. Stay firm.
此外，在支撑杆汇集交叉部b，横直的跨越段12由于长度较小，在固定部件受植入部位腔内压迫形变时，因而可以在横直的跨越段12较小的长度内实现与其临近的其它支撑杆的抵触，这使得支撑杆在横直的跨越段12处的摆动更小，位置更稳定。In addition, at the intersection b of the support rods, the length of the horizontal spanning section 12 is small. When the fixing component is compressed and deformed by the cavity of the implantation site, it is possible to achieve close contact within the relatively small length of the horizontal spanning section 12. The resistance of other support rods makes the swing of the support rods at the horizontal spanning section 12 smaller and the position more stable.
同样可参考图7，其简化示意出图5中固定部件的支撑杆形成交叉排列的情况，其中将支撑杆向四周延伸的外延段63的主体部分省略。支撑杆6可以具有较长的引出段61，由中心管件a引出，再基本横跨过中心管件a的管口延伸形成横直的跨域段62，之后再继续远离中心管件a向四周延伸形成外延段63的主体。显然，横直的跨域段62可以位于其它支撑杆之间，在图7中，位于支撑杆3和支撑杆9之间。Reference can also be made to FIG. 7 , which simplifies the situation in which the support rods of the fixed component form a cross arrangement in FIG. 5 , in which the main part of the extension section 63 extending around the support rod is omitted. The support rod 6 can have a longer lead-out section 61, which is led out from the central pipe a, and then extends basically across the mouth of the central pipe a to form a horizontal span section 62, and then continues to extend away from the central pipe a to form an extension. The body of paragraph 63. Obviously, the transverse span section 62 can be located between other support rods, in FIG. 7 between support rods 3 and 9 .
再参考图3和图7，作为优选的实施方案，横直的跨域段62可以是横向延伸至管口的外缘或其附近截止。例如，横直的跨域段62具有与中心管件a直径相近的长度。Referring again to FIGS. 3 and 7 , as a preferred embodiment, the horizontal span section 62 may extend laterally to the outer edge of the tube opening or end near it. For example, the horizontal span section 62 has a length similar to the diameter of the central tube a.
固定部件的某些实施例中，固定部件包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆，多个支撑杆均跨过中心管件的管口向其各自的对侧方向延伸至各自的末端并形成固定部件的径向外缘，其中，支撑杆具有自中心管件引出的基本沿中心管件的轴向延伸的引出段，跨越管口的跨越段，以及继续向外延伸形成固定部件的径向外缘的外延段，引出段经第一弯曲过渡为跨越段，再经第二弯曲过渡为外延段。In some embodiments of the fixing component, the fixing component includes a central pipe and a plurality of annularly arranged support rods branching out from one end of the central pipe. The plurality of support rods all span the opening of the central pipe toward their respective opposite ends. Laterally extending to their respective ends and forming the radial outer edge of the fixed component, wherein the support rod has a lead-out section extending from the central pipe and extending substantially along the axial direction of the central pipe, a spanning section spanning the pipe opening, and continuing outward. The extension section extends to form the radial outer edge of the fixed component. The lead-out section transitions to a spanning section through a first bend, and then transitions into an extension section through a second bend.
可参考图3，图3示出支撑杆1的引出段11，跨越段12、以及外延段，其中外延段的第一部分131和外延段的第二部分132被示出，外延段的主体部分未示出，可参考图1示出的外延段的主体部分的实施例。引出段11自中心管件引出并基本沿中心管件的轴向延伸，经第一弯曲过渡为跨越段12，跨越段12可以是如图3所示的基本横直跨越管口，也可以是斜向跨越管口，跨越段12再经第二弯曲过渡为外延段。Referring to Figure 3, Figure 3 shows the lead-out section 11, the spanning section 12, and the extension section of the support rod 1, in which the first part 131 of the extension section and the second part 132 of the extension section are shown, and the main part of the extension section is not shown. As shown, reference may be made to the embodiment of the main part of the epitaxial segment shown in FIG. 1 . The lead-out section 11 is led out from the central pipe and extends basically along the axial direction of the central pipe. After the first bend, it transitions into a spanning section 12. The spanning section 12 can be basically horizontal across the pipe mouth as shown in Figure 3, or can be diagonally across. The nozzle spans section 12 and then transitions to an extension section through the second bend.
在该实施例中，支撑杆1的外延段还包括由第二弯曲处基本沿中心管件的轴向延伸的外延段的第一部分131，第一部分131再过渡为第二部分132，向外延伸出外延段的主体部分。In this embodiment, the extension section of the support rod 1 also includes a first part 131 of the extension section that extends from the second bend substantially along the axial direction of the central pipe. The first part 131 then transitions into a second part 132 that extends outward. The main part of the extension section.
在另一个实施例中，参考图7的支撑杆6，其外延段63可以直接由跨越段62经第二弯曲处向外延伸出其主体部分，而基本不具有轴向延伸的部分，支撑杆6的外延段63的主体部分可参考图5所示实施例。In another embodiment, referring to the support rod 6 of FIG. 7 , its extension section 63 can directly extend outward from its main body portion through the second bend from the spanning section 62 without substantially having an axially extending portion. The support rod The main part of the extension section 63 of 6 can refer to the embodiment shown in FIG. 5 .
在某些实施例中，跨越段和引出段在第一弯曲处形成的夹角可以为70-110度。In some embodiments, the included angle formed by the spanning section and the lead-out section at the first bend may be 70-110 degrees.
在某些实施例中，外延段和跨越段在第二弯曲处形成的夹角大于90度，优选为100-160度。In some embodiments, the included angle formed by the extension section and the spanning section at the second bend is greater than 90 degrees, preferably 100-160 degrees.
支撑杆经由上述的引出段、跨越段和外延段构成，特别有利于降低支撑杆受压迫形变时的支撑杆根部的应力大小，显著改善固定部件的耐疲劳性能。The support rod is composed of the above-mentioned lead-out section, spanning section and extension section, which is particularly beneficial to reducing the stress at the root of the support rod when the support rod is compressed and deformed, and significantly improving the fatigue resistance of the fixed component.
某些实施例中，外延段先斜向延伸远离中心部件，经向外翻转后再向靠近中心部件方向延伸至支撑杆的末端。可以理解的，本领域技术人员也可以选择其它适合形状的外延段。In some embodiments, the extension section first extends obliquely away from the central component, and then extends toward the central component to the end of the support rod after being turned outward. It can be understood that those skilled in the art can also select other suitable shapes of extension segments.
发明人发现，在支撑杆直接由中心管件a斜向引出跨越管口形成用于构造固定部件外缘的外延段时，支撑杆连接中心管件a的根部是形变应力的集中区，当植入部位为活动的腔体时，例如左心耳，腔体保持持续的收缩和舒张，形成对固定部件变化的压迫力，支撑杆根部在持续的形变变化中容易发生疲劳断裂现象。The inventor found that when the support rod is directly led diagonally from the central pipe a across the pipe opening to form an extension section for constructing the outer edge of the fixed component, the root of the support rod connected to the central pipe a is a concentrated area of deformation stress. When the implantation site When it is a movable cavity, such as the left atrial appendage, the cavity maintains continuous contraction and relaxation, forming a changing pressure on the fixed components. The root of the support rod is prone to fatigue fracture during the continuous deformation changes.
有鉴于此，本发明实施例中的轴向延伸的引出段不具有加工为斜向的变形，因此自身不累积形变应力，通过跨越段两端的第一弯曲和第二弯曲，使得来源于外延段的形变应力向支撑杆的根部的传递显著减弱，支撑杆在方向相反的第一弯曲和第二弯曲处可通过弯曲变形降低应力传导。在某些实施例中，第一弯曲和第二弯曲处的弯曲变形导致的夹角的变化很小。In view of this, the axially extending lead-out section in the embodiment of the present invention does not have oblique deformation, so it does not accumulate deformation stress itself. Through the first bend and the second bend spanning both ends of the section, the extension section originates from The transmission of deformation stress to the root of the support rod is significantly weakened, and the support rod can reduce stress conduction through bending deformation at the first and second bends in opposite directions. In some embodiments, the bending deformation at the first bend and the second bend causes a small change in the included angle.
特别的，由于多个支撑杆的跨越段之间形成交叉排列，支撑杆的外延段形变或活动使得跨越段向相邻的另一个或多个支撑杆的跨越段移动接触，支撑杆之间的接触提供了额外的支撑力，抵御支撑杆的进一步形变或活动，从而可以保障支撑杆根部的应力处于较低的水平。这在某些情况下是特别有利的，例如支撑杆的外延段通常较长，并构成固定部件的外缘，多个支撑杆组合构成的固定部件外轮廓通常需要与植入部位的内腔形状相匹配，以形成有利的贴合和固定，本发明的实施例中，支撑杆外延段可以设置提供满足匹配变形的能力，同时利用支撑杆在引出段、跨越段的形状赋予低的应力传递，和支撑杆间的交叉排列接触提供的额外支撑方式，保持固定部件稳定的支撑杆排列组合结构和较低的根部应力，避免因支撑杆的外延段变形和活动较大导致固定部件构型的解散失效。In particular, due to the cross arrangement formed between the spanning sections of multiple support rods, the deformation or movement of the extension section of the support pole causes the spanning section to move and contact the spanning section of another adjacent support pole or multiple support poles, and the distance between the support poles is The contact provides additional support to resist further deformation or movement of the support rod, thereby ensuring that the stress at the root of the support rod is at a low level. This is particularly advantageous in some cases. For example, the extension section of the support rod is usually longer and forms the outer edge of the fixation component. The outer contour of the fixation component composed of multiple support rods usually needs to match the shape of the inner cavity of the implantation site. Matching to form favorable fit and fixation. In embodiments of the present invention, the extension section of the support rod can be configured to provide the ability to meet the matching deformation. At the same time, the shape of the support rod is used to impart low stress transmission in the lead-out section and the spanning section. The additional support method provided by the cross-arrangement contact between the support rods maintains the stable support rod arrangement structure of the fixed parts and lower root stress, and avoids the disintegration of the fixed part configuration due to the deformation and large movement of the extension section of the support rods. Invalid.
本发明某些实施例中，固定部件的支撑杆的个数可以是3-50个，优选为5-15个，图1和图5所示实施例中均为9个支撑杆。In some embodiments of the present invention, the number of support rods of the fixed component may be 3-50, preferably 5-15. In the embodiments shown in Figures 1 and 5, there are 9 support rods.
作为优选方案，支撑杆的个数通常选择为奇数个，在环形排列的奇数个支撑杆之间，可以是等间隔的，有利于在支撑杆对侧对应设置为另外的两个支撑杆之间的间隙，该支撑杆向其对侧方向延伸，穿过该间隙。例如，可以参考图3和图4，支撑杆1向其对侧延伸穿过支撑杆5和支撑杆6之间的间隙。可以理解，支撑杆的宽度或直径可以与该间隙的宽度相近，例如后者为前者的2倍至1.2倍大小，这种设置在某些情况下是有利的，支撑杆的宽度或直径与该间隙的宽度相近，可以使得该间隙两侧的支撑杆形成对穿过该间隙支撑杆的在周向的限位，这有助于进一步减少支撑杆的在固定部件周向方向的摇摆幅度，以及提供额外的对该支撑杆的支撑，从而增强固定部件在植入部位的固定能力。As a preferred solution, the number of support rods is usually selected to be an odd number. The odd number of support rods arranged in a ring can be equally spaced, which is beneficial to the corresponding arrangement of two other support rods on the opposite side of the support rod. gap, the support rod extends toward its opposite side and passes through the gap. For example, referring to FIGS. 3 and 4 , the support rod 1 extends to its opposite side through the gap between the support rods 5 and 6 . It can be understood that the width or diameter of the support rod can be similar to the width of the gap, for example, the latter is 2 times to 1.2 times the size of the former. This arrangement is advantageous in some cases. The width or diameter of the support rod is similar to the width of the gap. The width of the gap is similar, so that the support rods on both sides of the gap form a circumferential limit for the support rod passing through the gap, which helps to further reduce the swing amplitude of the support rod in the circumferential direction of the fixed component, and Provide additional support to the support rod, thereby enhancing the fixation ability of the fixation component at the implant site.
如上所述的，环形排布的各支撑杆，优选是向其对侧方向延伸的，即支撑杆的整体忽略其宽度变化，可以认为基本在一个平面内，在该延伸面内，支撑杆可有具有向上或向下的弯曲，例如前述的第一弯曲和第二弯曲。尽管某些实施例中支撑杆可以具有显著的不在一个平面内的偏转部分，但在某些情况下这可能是不利的，因为这可能造成支撑杆在向鞘管内回收时在植入部位腔内发生绕固定部件轴向的扭转，从而可能对植入部位的腔内壁造成无法控制的损伤。As mentioned above, each supporting rod arranged in an annular manner preferably extends in the opposite direction. That is, the entire supporting rod can be considered to be basically in a plane regardless of its width change. In this extended plane, the supporting rod can There are upward or downward bends, such as the aforementioned first bend and second bend. Although in some embodiments the support rod may have significant out-of-plane deflection, this may be disadvantageous in certain circumstances as it may cause the support rod to become trapped within the implant site lumen when retracted into the sheath. Axial torsion occurs around the fixation component, which may cause uncontrollable damage to the lumen wall of the implant site.
在固定部件的某些实施例中，中心管件和由中心管件一端向外分出的环形排布的多个支撑杆，其中，多个支撑杆均先跨过中心管件的管口并由此在中心管件的外侧形成交叉排列，再分别向四周延伸形成固定部件的径向外缘，其中，多个支撑杆按其环形排布位置以错位排序依次跨过中心管件的口形成交叉排列。In some embodiments of the fixed component, the central pipe and a plurality of annularly arranged support rods branching out from one end of the central pipe, wherein the plurality of support rods first cross the nozzle of the central pipe and thereby The outside of the central pipe is arranged in a cross arrangement, and then extends to the surroundings to form the radial outer edge of the fixed component. Among them, a plurality of support rods are arranged in a staggered order across the mouth of the central pipe in order according to their annular arrangement positions to form a cross arrangement.
可参考图5-11，特别是图6-8，其中，可以将构成固定部件的九个支撑杆沿其在固定部件的外周排列顺序依次命名为支撑杆1至支撑杆9，由于各支撑杆均为向各自的对侧延伸，因此该顺序与九个支撑杆在中心管件a处呈环形排列的顺序是相同的。本发明的优选实施方式中，各支撑杆不是按此顺序依次跨越管口形成的交叉排列，而是以错位排序依次跨过中心管件的口，形成交叉排列。具体地，可参考图6的实施例，沿中心管件的轴向方向，支撑杆1首先跨越管口，其次是支撑杆4，而后的次序依次是支撑杆7、支撑杆2、支撑杆5、支撑杆8、支撑杆3、支撑杆6、支撑杆9，最终形成固定部件的支撑杆汇集交叉部b。这样设置的优点在于，使得在支撑杆汇集交叉部b处，支撑杆的空间分布趋向均匀，不会出现较显著的分布的空区和密区。特别优选的方式，支撑杆的空间分布使得支撑杆汇集交叉部b形成柱形，其直径可与中心管件的直径接近。Referring to Figures 5-11, especially Figures 6-8, the nine support rods constituting the fixed part can be named support rods 1 to 9 along the order in which they are arranged on the periphery of the fixed part. They all extend to their respective opposite sides, so the sequence is the same as the sequence in which the nine support rods are arranged in a ring at the central pipe member a. In a preferred embodiment of the present invention, each support rod does not cross the mouth of the pipe in this order to form a cross arrangement, but instead crosses the mouth of the central pipe in a staggered order to form a cross arrangement. Specifically, referring to the embodiment of Figure 6, along the axial direction of the central pipe, the support rod 1 first crosses the pipe opening, followed by the support rod 4, and then in order, the support rod 7, the support rod 2, the support rod 5, The support rods 8, 3, 6, 9 finally form the support rods that form the fixed component at the intersection b. The advantage of this arrangement is that at the intersection b of the support rods, the spatial distribution of the support rods tends to be uniform, and there will be no obvious distributed empty areas and dense areas. In a particularly preferred manner, the spatial distribution of the support rods is such that the support rods converge at the intersection b to form a cylindrical shape, the diameter of which can be close to the diameter of the central pipe.
可供对比的，图1-4所示实施例中，固定部件的九个支撑杆则是以前述顺序的方式依次跨域管口，形成支撑杆汇集交叉部b。可参考图2，沿中心管件的轴向方向，支撑杆1首先跨越管口，其次是支撑杆2，而后的次序依次是支撑杆3、支撑杆4、支撑杆5、支撑杆6、支撑杆7、支撑杆8、支撑杆9。在支撑杆汇集交叉部b处，尽管也大致形成柱形，但支撑杆的空间分布明显不均匀，出现了明显的空区b1和密区b2。这种设置可能不是最佳的，因为这可能导致固定部件在轴向和周向的性能的不均匀性，例如，可能导致固定部件的外周向空区b1侧偏置而定位不准确，以及固定部件轴向在空区b1处抵抗压缩的能力降低。For comparison, in the embodiment shown in Figures 1-4, the nine support rods of the fixed component are sequentially spanned across the nozzle in the above-mentioned order to form a support rod collection intersection b. Referring to Figure 2, along the axial direction of the central pipe, support rod 1 first crosses the pipe opening, followed by support rod 2, and then in order, support rod 3, support rod 4, support rod 5, support rod 6, support rod 7. Support rod 8, support rod 9. At the intersection b of the support rods, although it is roughly cylindrical, the spatial distribution of the support rods is obviously uneven, and obvious empty areas b1 and dense areas b2 appear. This arrangement may not be optimal because it may lead to inhomogeneities in the performance of the fixing component in the axial and circumferential directions. For example, it may cause the outer circumference of the fixing component to be offset toward the empty area b1 side and cause inaccurate positioning, as well as fixation. The component's ability to resist compression is reduced axially in the empty area b1.
应该理解，多个支撑杆的错位排序方式并不必然要求如图6实施例中有规律的排布次序，例如还可以按照支撑杆1、4、2、5、3、9、6、8、7等类似错位无序次序，只要不是图2所示顺序即可，均可有助于改善支撑杆的空间分布。然而，优选的错位排序方式是根据支撑杆的数量和位置平均分组，按组次轮番从每组内选择一个支撑杆跨越管口，可参考图6，按支撑杆环形排布中的位置，分为三组，依次为支撑杆1、2、3，支撑杆4、5、6，和支撑杆7、8、9，每次从每组中选择一个对应的支撑杆跨越管口。这种优选的设置，更容易形成支撑杆汇集交叉部b的均匀空间分布。It should be understood that the staggered arrangement of multiple support rods does not necessarily require a regular arrangement order as shown in the embodiment of Figure 6. For example, support rods 1, 4, 2, 5, 3, 9, 6, 8, 7 and other similar misaligned and disordered orders, as long as they are not in the order shown in Figure 2, can help improve the spatial distribution of the support rods. However, the preferred misalignment sorting method is to group the support rods evenly according to the number and position, and select one support rod from each group in turn to span the pipe opening. Refer to Figure 6. According to the position of the support rods in the circular arrangement, divide There are three groups, namely support rods 1, 2, and 3, support rods 4, 5, and 6, and support rods 7, 8, and 9. Each time, a corresponding support rod is selected from each group to span the pipe opening. This preferred arrangement makes it easier to form a uniform spatial distribution of the support rod convergence intersections b.
在固定部件的一个实施例中，参考图3，支撑杆1的外延段包括轴向延伸的第一部分131，以及斜向向外延伸的第二部分132，跨越段12经第二弯曲过渡为外延段的第一部分，再经第三弯曲过渡为外延段的第二部分。显然，这种设置的支撑杆可以为固定部件的多个支撑杆中的一个或多个。这种设置除了降低支撑杆形变向根部的应力传递外，另外的一个显著的优点在于，有利于支撑杆汇集交叉部b形成较小的直径，从而特别有助于其回收入输送鞘管内。由于支撑杆汇集交叉部b的直径可以与中心管件a的直径相近，因此可以直接被收入输送鞘管内而不需要额外的挤压。优选的实施方式，上述第二部分的长度远大于第一部分。In one embodiment of the fixed component, referring to Figure 3, the extension section of the support rod 1 includes an axially extending first portion 131 and a second portion 132 that extends obliquely outward. The spanning section 12 transitions to an extension through a second bend. The first part of the segment is transformed into the second part of the extension segment through the third bend. Obviously, the support rod of this arrangement may be one or more of the plurality of support rods of the fixed component. In addition to reducing the stress transmission from the deformation of the support rod to the root, this arrangement also has another significant advantage in that it helps the support rods gather at the intersection b to form a smaller diameter, which is particularly helpful for its recovery into the delivery sheath. Since the diameter of the support rod convergence intersection b can be similar to the diameter of the central tube a, it can be directly received into the delivery sheath without additional extrusion. In a preferred embodiment, the length of the second part is much longer than that of the first part.
某些实施例中，参考图1和图5，外延段的长度通常可以选择远大于引出段和跨越段，以提供固定部件需要的直径大小，和足够的弹性变形能力。In some embodiments, referring to Figures 1 and 5, the length of the extension section can generally be selected to be much longer than the lead-out section and the spanning section to provide the required diameter of the fixed component and sufficient elastic deformation capability.
本发明的固定部件的一个实施例中，支撑杆的宽度沿其长度方向具有变化，其中，支撑杆在跨越段的宽度小于在引出段和/或外延段的宽度，或者，支撑杆在跨越段和引出段的宽度均小于在外延段的最大宽度，参考图1和图5。In one embodiment of the fixing component of the present invention, the width of the support rod changes along its length direction, wherein the width of the support rod in the spanning section is smaller than the width in the lead-out section and/or the extension section, or the support rod in the spanning section The width of the extension section and the lead-out section are both smaller than the maximum width of the extension section, refer to Figure 1 and Figure 5.
再参考图1和图5，支撑杆在外延段还可以选择设置锚刺14，以提供额外的固定于植入部位腔的能力。优选的实施方式中，支撑杆的末端设置为球形末端15，以减少不必要的对内腔壁的划伤。Referring again to Figures 1 and 5, anchors 14 can optionally be provided on the outer extension of the support rod to provide additional ability to be fixed to the cavity of the implantation site. In a preferred embodiment, the end of the support rod is set as a spherical end 15 to reduce unnecessary scratches on the inner cavity wall.
本发明实施例中，由中心管件一端向外分出的环形排布的多个支撑杆，中心管件和多个支撑杆可以是一体结构，也可以是分体结构，例如支撑杆与中心管件之间形成可拆卸连接，一种例子，中心管件的管周可以设有供支撑杆插入的插卡槽。多个支撑杆通常是由中心管件的管壁分出，但也可以是由中心管件的管壁外周引出。支撑杆可以通过各种方式固定于中心管件。In the embodiment of the present invention, there are a plurality of annularly arranged support rods branching out from one end of the central pipe. The central pipe and the plurality of support rods may be an integral structure or a separate structure, such as a support rod and a central pipe. A detachable connection is formed between them. In one example, the periphery of the central pipe may be provided with a card slot for the support rod to be inserted. The plurality of support rods are usually branched off from the pipe wall of the central pipe, but may also be led out from the outer periphery of the pipe wall of the central pipe. The support rod can be fixed to the center tube in various ways.
中心管件的管腔可以是在一端或两端管口封闭的，也可以是两端管口联通的。固定部件可以利用中心管件的管腔或管周与植入式医疗器械的其它部件实现连接，例如卡接、焊接、粘接等等方式。The lumen of the central pipe fitting may be closed at one or both ends, or may be connected to the pipe at both ends. The fixed component can be connected to other components of the implantable medical device by using the lumen or periphery of the central tube, such as snapping, welding, bonding, etc.
一个左心耳封堵器的实施例中，除固定部件外，还包括由多个丝编织而成的网状的可弹性压缩的密封部件，其具有轴向的两端，其中一端可以直接与中心管件连接，可参考图12和图13，或者通过连接件与中心管件连接。具体连接方式均是本领域技术人员可实施的常规技术手段。In one embodiment of the left atrial appendage occluder, in addition to the fixed component, it also includes a mesh-like elastically compressible sealing component woven from a plurality of wires, which has two axial ends, one of which can be directly connected to the center. For pipe connection, please refer to Figure 12 and Figure 13, or connect to the central pipe through a connecting piece. The specific connection methods are conventional technical means that can be implemented by those skilled in the art.
作为优选的实施方式，前述的固定部件的制备方法，可以包括如下步骤：As a preferred embodiment, the aforementioned method for preparing a fixed component may include the following steps:
将一个原料管件去除多余材料，得到在原料管件的管周上间隔分布有多个杆的中间体；Remove excess material from a raw pipe fitting to obtain an intermediate body with multiple rods spaced around the circumference of the raw pipe fitting;
将中间体的多个杆加工成所需要的形状并经热处理定型。The multiple rods of the intermediate body are processed into the required shape and shaped by heat treatment.
将原料管件去除多余材料，通常可以是激光切割的方式，然而也可以是用蚀刻剂蚀刻方式。原料管件通常可以是金属材料，例如不锈钢、镍钛合金等，但也可以是高分子聚合物材料。某些实施例中，原料管件还可以是人体内可吸收或可降解的，由此制得的固定部件可以具有在植入部位在可控的期限内被组织吸收或自我降解而无需额外通过手术取出。Removing excess material from raw pipe fittings is usually done by laser cutting, but it can also be etched with an etchant. Raw pipe fittings can usually be metal materials, such as stainless steel, nickel-titanium alloy, etc., but can also be polymer materials. In some embodiments, the raw material tube can also be absorbable or degradable in the human body, and the fixation component produced thereby can be absorbed by the tissue or self-degrade at the implantation site within a controllable period without additional surgery. take out.
同理，可以进一步制备含有前述固定部件的植入式医疗器械，将前述方法制得的固定部件与植入式医疗器械的其它部件在中心管件处连接。In the same way, an implantable medical device containing the aforementioned fixing component can be further prepared, and the fixing component produced by the aforementioned method is connected to other components of the implantable medical device at the central tube.
某些植入式医疗器械的实施例中，固定部件位于植入式医疗器械长度方向的一端，并通过中心部件与植入式医疗器械的其它部分连接。In some embodiments of the implantable medical device, the fixing component is located at one end of the length direction of the implantable medical device and is connected to other parts of the implantable medical device through the central component.
固定部件主要通过受植入部位腔内壁压迫的径向压缩产生的径向支撑力反作用于腔内壁，实现在腔内的固定，而例如在植入部位的腔搏动时，腔的容积或直径随收缩和舒张变化，固定部件受压迫的压缩直径也是变化的，可以将直径的变化量除以其未受束缚状态时的原始直径的百分比作为评价固定部件的压缩量。The fixation component mainly reacts on the inner wall of the cavity through the radial support force generated by the radial compression of the inner wall of the implantation site to achieve fixation in the cavity. For example, when the cavity at the implantation site pulsates, the volume or diameter of the cavity changes with The compression diameter of the fixed component also changes due to changes in contraction and relaxation. The compression amount of the fixed component can be evaluated by dividing the diameter change as a percentage of the original diameter in the unconstrained state.
在某些实施例中，固定部件可弹性压缩而具有可变的直径，固定部件被配置为满足在其径向压缩量由10％增大至30％的范围区间内，固定部件的径向支撑力的增大不超过20％。这种配置可能是有利的，在适宜的植入状态，固定部件的压缩量不宜过大或过小，例如压缩量在10％至30％的范围区间，并且考虑到植入部位的腔的尺寸测量不总是精确的，固定部件满足在压缩量一定范围区间内实现稳定固定是非常有必要的，而随压缩量的较小变化使得固定部件的径向支撑力伴随过大的变化可能是不希望的，过大的径向支撑力可能造成腔壁或组织的过分损伤，而过小的径向支撑力可能不满足固定部件在植入部位的稳定的固定。固定部件可以是前述的任一种包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆结构的实施例。然而不限于此，固定部件还可以是编织丝编织的网状结构或多个支撑杆以本领域已知的其它方式构成的，固定部件还可以是盘形、柱形、锥形等所需要的形状。In some embodiments, the fixing component is elastically compressible and has a variable diameter, and the fixing component is configured to satisfy the radial support of the fixing component within a range in which its radial compression increases from 10% to 30%. The increase in force shall not exceed 20%. This configuration may be advantageous. In a suitable implantation state, the compression amount of the fixation component should not be too large or too small, for example, the compression amount is in the range of 10% to 30%, and taking into account the size of the cavity of the implantation site The measurement is not always accurate. It is very necessary for the fixed component to achieve stable fixation within a certain range of compression. However, small changes in the amount of compression may cause excessive changes in the radial support force of the fixed component. Desirably, too large a radial support force may cause excessive damage to the cavity wall or tissue, while too small a radial support force may not satisfy the stable fixation of the fixation component at the implantation site. The fixing component may be any of the aforementioned embodiments including a central tube and a plurality of annularly arranged support rod structures branching out from one end of the central tube. However, it is not limited to this. The fixing component can also be a mesh structure woven with braided wire or a plurality of support rods constructed in other ways known in the art. The fixing component can also be disk-shaped, cylindrical, conical, etc. as required. shape.
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由10％增大至20％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured such that the increase in the radial support force of the fixing component does not exceed 20% when the radial compression increases from 10% to 20%. .
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由10％增大至15％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured such that the increase in the radial support force of the fixing component does not exceed 20% when the radial compression increases from 10% to 15%. .
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由15％增大至20％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured to meet the requirement that the increase in the radial support force of the fixing component does not exceed 20% when the radial compression amount increases from 15% to 20%. .
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由20％增大至30％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured such that the increase in the radial support force of the fixing component does not exceed 20% when the radial compression increases from 20% to 30%. .
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由20％增大至25％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured to meet the requirement that the radial support force of the fixing component increases by no more than 20% within the range in which its radial compression increases from 20% to 25%. .
本发明的某些实施例中，所述固定部件被配置为满足在其径向压缩量由25％增大至30％的范围区间内，固定部件的径向支撑力的增大不超过20％。In some embodiments of the present invention, the fixing component is configured such that the increase in the radial support force of the fixing component does not exceed 20% when the radial compression increases from 25% to 30%. .
可进一步参考图16，示出了某些固定部件实施例的压缩量和径向支撑力的变化曲线，其中，固定部件实施例是图1或图5所示的构造，在10％-35％的压缩范围区间内的径向支撑力在0.5N±0.1N范围内。Further reference may be made to FIG. 16 , which shows the variation curve of compression amount and radial support force of certain fixed component embodiments, wherein the fixed component embodiment is the configuration shown in FIG. 1 or FIG. 5 , at 10%-35%. The radial support force within the compression range is within the range of 0.5N±0.1N.
径向支撑力的测试，是本领域内所习知的技术。例如可参考ASTM F3067-14或者行业标准YY/T 1660-2019的虹膜法测试。The test of radial support force is a well-known technology in this field. For example, you can refer to ASTM F3067-14 or the iris method test of industry standard YY/T 1660-2019.
本发明的某些实施例中，提供一种用于植入式医疗器械的固定部件，固定部件可弹性压缩而具有可变的直径，固定部件被配置为满足在其径向压缩量由10％增大至30％的范围区间内，固定部件的径向支撑力为0.4N-0.7N。在某些实施例中，固定部件被配置为满足在其径向压缩量由10％增大至30％的范围区间内，固定部件的径向支撑力为0.4N-0.6N。在某些实施例中，固定部件被配置为满足在其径向压缩量由10％增大至20％或25％的范围区间内，固定部件的径向支撑力为0.4N-0.6N。在某些实施例中，固定部件被配置为满足在其径向压缩量由10％增大至20％或25％的范围区间内，固定部件的径向支撑力为0.4N-0.7N。In some embodiments of the present invention, a fixing component for an implantable medical device is provided. The fixing component is elastically compressible and has a variable diameter. The fixing component is configured to satisfy a radial compression amount of 10%. Within the range of 30%, the radial support force of the fixed component is 0.4N-0.7N. In some embodiments, the fixing component is configured such that the radial support force of the fixing component is 0.4N-0.6N within a range in which the radial compression increases from 10% to 30%. In some embodiments, the fixing component is configured to meet a radial support force of 0.4N-0.6N within a range in which the radial compression increases from 10% to 20% or 25%. In some embodiments, the fixing component is configured to have a radial support force of 0.4N-0.7N within a range in which the radial compression increases from 10% to 20% or 25%.
固定部件可以是前述的任一种包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆结构的实施例，其中，多个支撑杆先在中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成固定部件的径向外缘。然而不限于此，固定部件还可以是编织丝编织的网状结构或多个支撑杆以本领域已知的其它方式构成的，固定部件还可以是盘形、柱形、锥形等所需要的形状。The fixing component may be any of the aforementioned embodiments including a central pipe and a plurality of annularly arranged support rod structures branching out from one end of the central pipe, wherein the plurality of support rods are first located outside the opening of the central pipe. The sides are gathered together to form a cross arrangement and then respectively extend around to form the radial outer edge of the fixed component. However, it is not limited to this. The fixing component can also be a mesh structure woven with braided wire or a plurality of support rods constructed in other ways known in the art. The fixing component can also be disk-shaped, cylindrical, conical, etc. as required. shape.
固定部件在工作状态产生的径向支撑力不易过大或过小，特别是，发明人发现，在左心耳内或类似的生理组织结构内，固定部件的径向支撑力为0.4N-0.6N是适宜的，其减少过大的器械和组织间摩擦，保持必要的负载和固定能力，并不过分限制心耳的收缩或搏动。动物实验证实没有明显的心耳内组织损伤。The radial support force generated by the fixed component in the working state is not easy to be too large or too small. In particular, the inventor found that in the left atrial appendage or similar physiological tissue structure, the radial support force of the fixed component is 0.4N-0.6N. It is suitable to reduce excessive friction between instruments and tissues, maintain necessary load and fixation capabilities, and does not excessively restrict the contraction or pulsation of the atrial appendage. Animal experiments confirmed no obvious tissue damage within the atrial appendage.
可以理解，本发明实施例的固定部件的在植入状态的变形，主要是由支撑杆的由交叉排列位置向四周延伸出的部分发生变形，例如支撑杆的弯曲加大、轴向伸长或向固定部件的内部方向偏移。某些实施例中，固定部件的在植入状态的变形是在其径向压缩量由10％至30％的范围区间内。It can be understood that the deformation of the fixation component in the implanted state according to the embodiment of the present invention is mainly caused by the deformation of the portion of the support rod extending from the cross-arranged position to the surroundings, such as the increase in bending, axial elongation or expansion of the support rod. Offset toward the inside of the fixed component. In some embodiments, the deformation of the fixation component in the implanted state is within a range of 10% to 30% of its radial compression.
本发明的某些实施例中，提供一种用于植入式医疗器械的固定部件，固定部件可弹性压缩而具有可变的直径，固定部件被配置为满足在其径向压缩量由10％增大至30％的范围区间内，固定部件的径向支撑力的平均增率为k1；固定部件被配置为满足在其径向压缩量由0增大至10％的范围区间内，固定部件的径向支撑力的平均增率为k2；固定部件被配置为满足在其径向压缩量由30％增大至50％的范围区间内，固定部件的径向支撑力的平均增率为k3；In some embodiments of the present invention, a fixing component for an implantable medical device is provided. The fixing component is elastically compressible and has a variable diameter. The fixing component is configured to satisfy a radial compression amount of 10%. Within the range that increases to 30%, the average increase rate of the radial support force of the fixed component is k1; the fixed component is configured to satisfy that within the range that its radial compression increases from 0 to 10%, the fixed component The average increase rate of the radial support force of the fixed component is k2; the fixed component is configured to satisfy the average increase rate of the radial support force of the fixed component k3 within the range in which its radial compression increases from 30% to 50%. ;
其中，k1小于k2，且k1小于k3；Among them, k1 is smaller than k2, and k1 is smaller than k3;
其中，固定部件的径向支撑力的平均增率k为固定部件的径向压缩量变化前后的差值与固定部件的对应的径向支撑力变化前后的差值的比值的绝对值的倒数。The average increase rate k of the radial support force of the fixed component is the reciprocal of the absolute value of the ratio of the difference between the radial compression amount of the fixed component before and after the change and the difference between the corresponding radial support force of the fixed component before and after the change.
例如，一个图5所示结构的固定部件，被配置为满足径向压缩量为10％、30％、50％时，测得其径向支撑力分别为0.4N、0.6N、0.9N，相应固定部件的径向支撑力的平均增率k可分别计算如下。For example, when a fixed component of the structure shown in Figure 5 is configured to meet the radial compression of 10%, 30%, and 50%, the measured radial support forces are 0.4N, 0.6N, and 0.9N respectively. Correspondingly The average increase rate k of the radial support force of the fixed component can be calculated as follows.
k1＝1/((30％-10％)/(0.6-0.4))＝1k1＝1/((30%-10%)/(0.6-0.4))＝1
k2＝1/((10％-0％)/(0.4-0))＝4k2=1/((10%-0%)/(0.4-0))=4
k3＝1/((50％-30％)/(0.9-0.6))＝1.5k3=1/((50%-30%)/(0.9-0.6))=1.5
某些实施例中，固定部件被配置为满足在其径向压缩量由10％增大至25％的范围区间内，固定部件的径向支撑力的平均增率为k1；固定部件被配置为满足在其径向压缩量由0增大至10％的范围区间内，固定部件的径向支撑力的平均增率为k2；固定部件被配置为满足在其径向压缩量由25％增大至35％或40％的范围区间内，固定部件的径向支撑力的平均增率为k3；In some embodiments, the fixing component is configured to satisfy the average increase rate k1 of the radial support force of the fixing component within the range in which its radial compression increases from 10% to 25%; the fixing component is configured as The average increase rate of the radial support force of the fixed component is k2 when its radial compression increases from 0 to 10%; the fixed component is configured to satisfy that when its radial compression increases from 25% Within the range of 35% or 40%, the average increase rate of the radial support force of the fixed component is k3;
其中，k1小于k2，且k1小于k3。Among them, k1 is smaller than k2, and k1 is smaller than k3.
某些实施例中，固定部件被配置为满足在其径向压缩量由10％增大至20％的范围区间内，固定部件的径向支撑力的平均增率为k1；固定部件被配置为满足在其径向压缩量由0增大至10％的范围区间内，固定部件的径向支撑力的平均增率为k2；固定部件被配置为满足在其径向压缩量由20％增大至30％或35％或40％的范围区间内，固定部件的径向支撑力的平均增率为k3；In some embodiments, the fixing component is configured to satisfy the average increase rate k1 of the radial support force of the fixing component within the range in which its radial compression increases from 10% to 20%; the fixing component is configured as The average increase rate of the radial support force of the fixed component is k2 when its radial compression increases from 0 to 10%; the fixed component is configured to satisfy that when its radial compression increases from 20% Within the range of 30% or 35% or 40%, the average increase rate of the radial support force of the fixed component is k3;
其中，k1小于k2，且k1小于k3。Among them, k1 is smaller than k2, and k1 is smaller than k3.
本发明的某些实施例中，提供一种用于植入式医疗器械的固定部件，固定部件可弹性压缩而具有可变的直径，固定部件包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆，其中，多个支撑杆先在中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成固定部件的径向外缘，其中，在交叉排列处，至少有一个支撑杆与另外的一个或两个或更多个支撑杆是贴触的。参考图1-7，在非受束缚状态下，固定部件的前述交叉排列位置处，支撑杆之间可以是有间隙的，并在受压缩状态下，部分的或全部的支撑杆之间可以受迫贴触。然而不限于此，某些实施例中，在非受束缚状态下，部分的支撑杆之间也可以是直接贴触的，这进一步增强了对支撑杆的支撑和限位效果。In some embodiments of the present invention, a fixing component for an implantable medical device is provided. The fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and a tube branching out from one end of the central tube. A plurality of support rods arranged in an annular shape, wherein the plurality of support rods are first gathered on the side outside the mouth of the central pipe to form a cross arrangement, and then extended to the surroundings respectively to form the radial outer edge of the fixed component, wherein, at the cross arrangement , at least one support rod is in contact with one or two or more other support rods. Referring to Figures 1-7, in the unconstrained state, there may be gaps between the support rods at the aforementioned cross-arranged positions of the fixed components, and in the compressed state, some or all of the support rods may be restrained. Forced contact. However, it is not limited to this. In some embodiments, in an unconstrained state, some of the support rods may be in direct contact with each other, which further enhances the support and limiting effect of the support rods.
本发明的某些实施例中，提供一种用于植入式医疗器械的固定部件，固定部件可弹性压缩而具有可变的直径，固定部件包括中心管件和由中心管件一端向外分出的环形排布的多个支撑杆，其中，多个支撑杆先在中心管件的管口外的一侧汇集形成交叉排列后再分别向四周延伸形成固定部件的径向外缘，其中，在交叉排列处，至少有一个支撑杆在环绕其延伸方向的周遭空间内被三个或四个另外的支撑杆限制活动。In some embodiments of the present invention, a fixing component for an implantable medical device is provided. The fixing component is elastically compressible and has a variable diameter. The fixing component includes a central tube and a tube branching out from one end of the central tube. A plurality of support rods arranged in an annular shape, wherein the plurality of support rods are first gathered on the side outside the mouth of the central pipe to form a cross arrangement, and then extended to the surroundings respectively to form the radial outer edge of the fixed component, wherein, at the cross arrangement , at least one support rod is restricted in movement by three or four other support rods in the surrounding space around its extension direction.
以上对本发明进行了详细介绍，本发明中应用具体个例对本发明的实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明，应当指出，对于本技术领域的技术人员来说，在不脱离本发明原理的前提下，还可对本发明进行若干改进，这些改进也落入本发明权利要求的保护范围内。The present invention has been introduced in detail above. Specific examples are used to illustrate the implementation of the present invention. The description of the above embodiments is only used to help understand the present invention. It should be pointed out that for those skilled in the art, Without departing from the principle of the present invention, several improvements can be made to the present invention, and these improvements also fall within the protection scope of the claims of the present invention.
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| CN202211165211 | 2022-09-23 | ||
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| CN202310731422.5APendingCN116942236A (en) | 2022-06-23 | 2023-06-19 | Fixing part, preparation method thereof and implantable medical device comprising fixing part |
| CN202310732635.XAPendingCN116942237A (en) | 2022-06-23 | 2023-06-19 | Fixing part, preparation method thereof and implantable medical device comprising fixing part |
| Application Number | Title | Priority Date | Filing Date |
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| CN202310732635.XAPendingCN116942237A (en) | 2022-06-23 | 2023-06-19 | Fixing part, preparation method thereof and implantable medical device comprising fixing part |
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