CN111773460A - Blood pump rotor - Google Patents
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Abstract
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Translated fromChinese技术领域technical field
本发明涉及医疗器械技术领域，具体涉及一种血泵转子。The invention relates to the technical field of medical devices, in particular to a blood pump rotor.
背景技术Background technique
目前，在一些大型手术特别涉及心脏手术时，在保障对心脏进行手术操作的同时，还要使医疗对象的血液正常运转，保证医疗对象的血液正常流通，使医疗对象维持正常的生命体征。At present, when some major operations especially involve cardiac surgery, while ensuring the operation of the heart, it is necessary to make the blood of the medical object run normally, to ensure the normal blood circulation of the medical object, and to maintain the normal vital signs of the medical object.
目前常用血泵装置来促使手术中的医疗对象的血液正常流通，即将血泵装置具有血泵的一端等插入医疗对象的心室内，血泵装置的另一端插入心脏的动脉中，通过血泵的运转，将心脏心室内的血液抽向医疗对象的动脉中，从而保证医疗对象的正常血液循环，以在对医疗对象进行心脏相关手术时，仍能使医疗对象的血液正常流通。At present, blood pump devices are commonly used to promote the normal circulation of blood of medical objects during surgery. It operates to pump the blood in the ventricle of the heart into the arteries of the medical object, so as to ensure the normal blood circulation of the medical object, so that the blood of the medical object can still circulate normally when the medical object is undergoing heart-related surgery.
但是，目前的血泵装置中的血泵，由于是需泵抽血液，这对泵特别是泵的转子的要求特别高，不仅需要保证血泵转子的运转效率，还需要保证泵送对象即血液的生理指标不受影响。这里，血液的生理指标主要包括白细胞指标、红细胞指标、血红蛋白指标、血清结合珠蛋白指标、血小板指标等主要指标。而血泵在高速旋转过程中，在对血液泵送的同时，也会对血液中的生理指标造成影响，如血泵转子的叶片在高速旋转过程中，会对血液中的血红细胞的细胞壁进行破坏，而血液中的大量血红细胞的细胞壁被破坏后，会导致血液的溶血效应，导致医疗对象处于溶血并发症，严重的危及生命。However, since the blood pump in the current blood pump device needs to pump blood, the requirements for the pump, especially the rotor of the pump are particularly high. Physiological indicators are not affected. Here, the physiological indexes of blood mainly include major indexes such as white blood cell indexes, red blood cell indexes, hemoglobin indexes, serum haptoglobin indexes, and platelet indexes. During the high-speed rotation of the blood pump, while pumping the blood, it will also affect the physiological indicators in the blood. After the cell wall of a large number of red blood cells in the blood is destroyed, it will cause the hemolytic effect of the blood, resulting in the complications of hemolysis in the medical object, which is seriously life-threatening.
目前的血泵装置一般只关注泵送效率，对于泵送血液的生理指标并不关注，主要原因是目前血泵装置中的血泵由于要置入医疗对象的体内，因此血泵的体积较小，一般均是关注血泵的工作效率，对血泵的泵送对象血液的生理指标关注较少。但是，由于血泵装置直接作用于医疗对象的血液，难免会对血液造成相应的破坏，对于一些溶血耐受差的医疗对象，特别是有并发症的医疗对象，血液生理指标的微小改变，对于有并发症的医疗对象而言都是致命的。遗憾的是，目前的血泵装置均是关注血泵的泵送效率及血泵装置的尺寸等，而对于血泵装置对血液生理指标的关注几乎没有。The current blood pump device generally only pays attention to the pumping efficiency, and does not pay attention to the physiological indicators of pumping blood. , generally pay attention to the working efficiency of the blood pump, and pay less attention to the physiological indicators of the blood pumped by the blood pump. However, because the blood pump device directly acts on the blood of the medical object, it will inevitably cause corresponding damage to the blood. For some medical objects with poor hemolysis tolerance, especially those with complications, the slight changes in blood physiological indicators will not affect the blood. It is fatal to medical subjects with complications. Unfortunately, the current blood pump devices all focus on the pumping efficiency of the blood pump and the size of the blood pump device, but little attention is paid to the blood physiological indicators of the blood pump device.
发明内容SUMMARY OF THE INVENTION
有鉴于此，本发明的目的在于提供一种血泵转子，该血泵转子能够为医疗对象泵送足够的血液，且几乎不会破坏血液的各项生理指标。In view of this, the purpose of the present invention is to provide a blood pump rotor, which can pump enough blood for a medical object and hardly destroy various physiological indexes of the blood.
为实现上述目的，本发明采用以下技术方案：To achieve the above object, the present invention adopts the following technical solutions:
本发明提供一种血泵转子，包括：柱形转轴和叶片；所述叶片具有柔性部和硬质部，所述柔性部和所述硬质部沿所述柱形转轴的轴向分布且一体平滑连接；所述叶片基于柔性部和硬质部混合的叶根而连接于所述柱形转轴的周缘；The invention provides a blood pump rotor, comprising: a cylindrical rotating shaft and a blade; the blade has a flexible part and a hard part, and the flexible part and the hard part are distributed along the axial direction of the cylindrical rotating shaft and are integrated Smooth connection; the blade is connected to the periphery of the cylindrical shaft based on the blade root where the flexible part and the hard part are mixed;
所述柔性部的材质的弹性模量小于所述硬质部的材质的弹性模量；The elastic modulus of the material of the flexible part is smaller than the elastic modulus of the material of the hard part;
所述柱形转轴旋转时，泵送对象能对所述叶片施加反作用推力，所述叶片的柔性部形变而使所述叶片整体沿反作用推力方向弯曲，泵送对象在弯曲叶片的带动下被泵送至目标方向。When the cylindrical shaft rotates, the pumping object can exert reaction thrust on the blade, and the flexible part of the blade deforms to bend the entire blade in the direction of the reaction thrust. The pumping object is driven by the curved blade to be pumped. sent to the target direction.
作为一种实现方式，所述柔性部的材质的弹性模量为8Mpa至80Mpa；所述硬质部的材质的弹性模量为35Mpa至195Mpa。As an implementation manner, the elastic modulus of the material of the flexible part is 8Mpa to 80Mpa; the elastic modulus of the material of the hard part is 35Mpa to 195Mpa.
作为一种实现方式，所述柔性部包括两种以上的不同材质段，所述硬质部包括两种以上的不同材质段；As an implementation manner, the flexible portion includes two or more different material segments, and the hard portion includes two or more different material segments;
所述柔性部和所述硬质部沿所述柱形转轴的轴向交替间隔排列分布；或者，The flexible part and the hard part are alternately arranged and distributed along the axial direction of the cylindrical shaft; or,
所述柔性部和所述硬质部沿所述柱形转轴的轴向按材质弹性模量由大到小或由小到大的顺序依次排列分布；或者，The flexible part and the hard part are arranged and distributed in the order of material elastic modulus from large to small or from small to large along the axial direction of the cylindrical shaft; or,
沿所述柱形转轴的轴向，所述柔性部位于所述叶片的两端、所述硬质部位于所述叶片的中部而排列分布；或者，Along the axial direction of the cylindrical rotating shaft, the flexible parts are located at both ends of the blade, and the hard parts are located in the middle part of the blade and are arranged and distributed; or,
沿所述柱形转轴的轴向，所述硬质部所位于所述叶片的两端、所述柔性部位于所述叶片的中部而排列分布。Along the axial direction of the cylindrical rotating shaft, the hard parts are located at both ends of the blade, and the flexible parts are located in the middle of the blade and are arranged and distributed.
作为一种实现方式，所述柔性部包括一种材质段，所述硬质部包括两种以上的不同材质段；As an implementation manner, the flexible portion includes one material segment, and the hard portion includes two or more different material segments;
所述柔性部夹设于两种以上的不同材质段的所述硬质部中而分布；或者，The flexible portion is sandwiched and distributed among the hard portions of two or more different material segments; or,
所述柔性部位于两种以上的不同材质段的所述硬质部的一侧而分布。The flexible parts are distributed on one side of the hard parts of two or more different material segments.
作为一种实现方式，所述柔性部包括两种以上的材质段，所述硬质部包括一种材质段；As an implementation manner, the flexible portion includes two or more material segments, and the hard portion includes one material segment;
所述硬质部夹设于两种以上的不同材质段的所述柔性部中而分布；或者，The hard part is sandwiched and distributed in the flexible parts of two or more different material segments; or,
所述硬质部位于两种以上的不同材质段的所述柔性部的一侧而分布。The hard parts are distributed on one side of the flexible parts of two or more different material segments.
作为一种实现方式，所述柔性部和所述硬质部在所述柱形转轴的轴向的长度比为1:3至6:1。As an implementation manner, the length ratio of the flexible portion and the hard portion in the axial direction of the cylindrical rotating shaft is 1:3 to 6:1.
作为一种实现方式，所述叶片的柔性部和硬质部在所述柱形转轴的轴向的长度比为：3:8、1:1、2:1、100:37、28:9、24:7或17:4。As an implementation manner, the length ratio of the flexible part and the hard part of the blade in the axial direction of the cylindrical shaft is: 3:8, 1:1, 2:1, 100:37, 28:9, 24:7 or 17:4.
作为一种实现方式，所述叶片为1至6片。As an implementation manner, the blades are 1 to 6 pieces.
作为一种实现方式，所述叶片为1片时，所述叶片从所述柱形转轴一端的周缘处呈向所述柱形转轴的另一端运动的方式绕设于所述柱形转轴的另一端的周缘上；所述叶片绕设所述柱形转轴的周缘的周数为0.2至5周。As an implementation manner, when the number of blades is one, the blade is wound around the other end of the cylindrical rotating shaft in a manner of moving from the peripheral edge of one end of the cylindrical rotating shaft to the other end of the cylindrical rotating shaft. on the peripheral edge of one end; the number of cycles of the blade around the peripheral edge of the cylindrical rotating shaft is 0.2 to 5 cycles.
作为一种实现方式，所述叶片为2片至6片时，所述叶片从所述柱形转轴一端的周缘处的等分处呈向所述柱形转轴的另一端运动的方式，各叶片以平行方式绕设于所述柱形转轴的另一端的周缘的对应等分处；所述叶片绕设所述柱形转轴的周缘的周数为0.1至5周。As an implementation manner, when the number of the blades is 2 to 6, the blades move from the equal parts of the circumference of one end of the cylindrical rotating shaft to the other end of the cylindrical rotating shaft. The blades are wound around the corresponding equal divisions of the peripheral edge of the other end of the cylindrical rotating shaft in a parallel manner;
本发明的有益效果：Beneficial effects of the present invention:
本发明的血泵转子结构，血泵转子的叶片部分采用柔性材质制成，叶片具有柔性部和硬质部，所述柔性部和所述硬质部沿所述柱形转轴的轴向分布且一体平滑连接；柔性部的材质的弹性模量小于硬质部的材质的弹性模量。本发明实施例通过对血泵转子的叶片的材质进行相应的选材，使血泵转子在旋转时，使血泵转子的柔性部分形变而弯曲，由于柔性部和硬质部之间沿转轴的轴向交叉设置或部分交叉设置，柔性部的弯曲能够带动硬质部随之变形，血泵转子的叶片通过设置柔性部，在泵旋转过程中，血泵转子的叶片在泵送血液时会有弯曲变形，这对于血液的生理指标而言破坏较小，特别是对血液中的血红细胞，几乎不会破坏，另外，对于血液中的其他生理指标，也几乎没有任何的影响。因此，本发明实施例的血泵转子中的叶片设计，可保证泵送血液的生理指标，能适用于任何的医疗对象，特别是具有并发症的医疗对象。In the blood pump rotor structure of the present invention, the blade part of the blood pump rotor is made of flexible material, the blade has a flexible part and a hard part, and the flexible part and the hard part are distributed along the axial direction of the cylindrical rotating shaft and One-piece and smooth connection; the elastic modulus of the material of the flexible part is smaller than that of the material of the hard part. In the embodiment of the present invention, the material of the blade of the blood pump rotor is selected accordingly, so that when the blood pump rotor rotates, the flexible part of the blood pump rotor is deformed and bent. Set in a cross or partially cross, the bending of the flexible part can drive the deformation of the hard part, and the blades of the blood pump rotor pass through the flexible part. During the rotation of the pump, the blades of the blood pump rotor will bend when pumping blood. Deformation has little damage to the physiological indicators of the blood, especially the red blood cells in the blood, and hardly destroys it. In addition, it has almost no effect on other physiological indicators in the blood. Therefore, the blade design in the blood pump rotor of the embodiment of the present invention can ensure the physiological index of pumped blood, and can be applied to any medical object, especially a medical object with complications.
附图说明Description of drawings
图1为本发明实施例的血泵转子的组成结构示意图。FIG. 1 is a schematic structural diagram of a blood pump rotor according to an embodiment of the present invention.
图2为本发明实施例的血泵转子及叶片的组成结构示意图。FIG. 2 is a schematic diagram of the composition structure of the blood pump rotor and the blades according to the embodiment of the present invention.
图3为本发明实施例的血泵转子及叶片的组成结构示意图。FIG. 3 is a schematic structural diagram of the composition of the blood pump rotor and the blades according to the embodiment of the present invention.
图4为本发明实施例的血泵转子及叶片的组成结构示意图。FIG. 4 is a schematic structural diagram of the composition of the blood pump rotor and the blades according to the embodiment of the present invention.
图5为本发明实施例的血泵转子及叶片的组成结构示意图。FIG. 5 is a schematic structural diagram of the composition of the blood pump rotor and the blades according to the embodiment of the present invention.
图6为本发明实施例的血泵转子及叶片的组成结构示意图。FIG. 6 is a schematic structural diagram of the composition of the blood pump rotor and the blades according to the embodiment of the present invention.
图7为本发明实施例的血泵转子的叶片柱形转轴设计示意图。FIG. 7 is a schematic diagram of the design of the blade cylindrical rotating shaft of the blood pump rotor according to the embodiment of the present invention.
图8为本发明实施例的血泵转子的叶片角沿程分布图。FIG. 8 is a distribution diagram of the blade angle along the path of the blood pump rotor according to the embodiment of the present invention.
图9为本发明实施例的血泵转子的柱形转轴的设计曲线图。FIG. 9 is a design curve diagram of a cylindrical rotating shaft of a blood pump rotor according to an embodiment of the present invention.
具体实施方式Detailed ways
以下结合附图，详细阐明本发明实施例技术方案的实质。The essence of the technical solutions of the embodiments of the present invention will be explained in detail below with reference to the accompanying drawings.
图1为本发明的血泵转子组成结构示意图，如图1所示，本发明的血泵转子包括：柱形转轴10和叶片20。FIG. 1 is a schematic diagram of the structure of the blood pump rotor of the present invention. As shown in FIG. 1 , the blood pump rotor of the present invention includes: a cylindrical
图2为本发明实施例的血泵转子的叶片的组成结构示意图，如图2所示，本发明实施例的叶片20具有柔性部201和硬质部202，所述柔性部201和所述硬质部 202沿所述柱形转轴10的轴向分布且一体平滑连接；所述叶片20基于柔性部201和硬质部202混合的叶根而连接于所述柱形转轴10的周缘；FIG. 2 is a schematic diagram of the composition structure of the blade of the blood pump rotor according to the embodiment of the present invention. As shown in FIG. 2, the
本发明实施例中，所述柔性部201的材质的弹性模量为8Mpa至80Mpa；所述硬质部202的材质的弹性模量为35Mpa至195Mpa，所述柔性部201的材质的弹性模量小于所述硬质部202的材质的弹性模量；In the embodiment of the present invention, the elastic modulus of the material of the
所述柱形转轴10旋转时，泵送对象能对所述叶片20施加反作用推力，所述叶片20的柔性部201形变而使所述叶片20整体沿反作用推力方向弯曲，泵送对象在弯曲叶片的带动下被泵送至目标方向。When the
作为一种实现方式，本发明实施例的血泵转子中，所述柔性部和所述硬质部在所述柱形转轴的轴向的长度比为1:3至6:1。优选地，所述柔性部201和所述硬质部 202在所述柱形转轴的轴向的长度比为3:8、1:1、2:1、100:37、28:9、24:7或17:4。As an implementation manner, in the blood pump rotor of the embodiment of the present invention, the length ratio of the flexible part and the hard part in the axial direction of the cylindrical rotating shaft is 1:3 to 6:1. Preferably, the length ratio of the
本发明实施例的血泵转子中，通过对叶片20的材质进行相应的选材，使血泵转子在旋转时，使血泵转子的柔性部分形变而弯曲，由于柔性部201和硬质部202之间沿转轴的轴向交叉设置或部分交叉设置，柔性部201的弯曲能够带动硬质部202 随之变形，血泵转子的叶片20通过设置柔性部201，在泵旋转过程中，血泵转子的叶片20在泵送血液时会有弯曲变形，这对于血液的生理指标而言破坏较小，特别是对血液中的血红细胞，几乎不会破坏，另外，对于血液中的其他生理指标，也几乎没有任何的影响。In the blood pump rotor of the embodiment of the present invention, the material of the
溶血是指血液中的红细胞破裂，使得红细胞内的血红蛋白溢出而溶于血液的现象。溶血会导致红细胞形态学以及生物化学特性发生改变、寿命缩短甚至完全破裂，从而使红细胞向组织和器官输送氧气的能力降低。此外，溶血后血浆游离血红蛋白浓度升高，多余的游离血红蛋白需要通过肾脏排出，因此可能会导致肾功能损伤以及多器官衰竭。本发明实施例中，血量估算是根据实验测量得到的筒单流场内流动参数与溶血破坏量的定量关系，经过合理地假设、变形，建立适用于复杂流场的溶血模型。目前，大部分进行定量溶血估算的研究都是建立在幂律方程的基础之上的。幂律方程描述的是简单流场中溶血指数(HI)与剪切力(τ)、曝光时间(texp)的关系：Hemolysis refers to the rupture of red blood cells in the blood, causing the hemoglobin in the red blood cells to overflow and dissolve in the blood. Hemolysis can lead to changes in the morphological and biochemical properties of red blood cells, shortened lifespan, or even complete rupture, thereby reducing the ability of red blood cells to deliver oxygen to tissues and organs. In addition, the plasma free hemoglobin concentration increases after hemolysis, and the excess free hemoglobin needs to be excreted by the kidneys, which may lead to renal damage and multiple organ failure. In the embodiment of the present invention, the blood volume estimation is based on the quantitative relationship between the flow parameters in the single flow field and the hemolytic damage amount obtained by the experimental measurement. After reasonable assumption and deformation, a hemolysis model suitable for the complex flow field is established. At present, most studies on quantitative hemolysis estimation are based on power-law equations. The power-law equation describes the relationship between the hemolysis index (HI), shear force (τ), and exposure time (texp ) in a simple flow field:
其中，溶血指数HI定义为血浆游离血红蛋白浓度的增量(ΔHb)与全血血红蛋白浓度(Hb)的比值。C、α、β是通过实验数据进行回归分析后得到的常数。Among them, the hemolysis index HI is defined as the ratio of the increase in plasma free hemoglobin concentration (ΔHb) to the whole blood hemoglobin concentration (Hb). C, α, and β are constants obtained by regression analysis of experimental data.
综上所述，溶血的大小与剪切力与曝光时间有关，当叶片20中采用本发明实施例提出的结构设计时，叶片20的叶尖中部分是柔性材料时，转子叶片20会沿旋转方向相反的方向弯曲，使得在叶尖的速度分布得到改善，从而减小叶尖位置剪切力的大小，减小叶尖位置血液溶血的可能性。To sum up, the magnitude of hemolysis is related to the shear force and exposure time. When the
另外，本发明实施例的血泵转子结构的设计还能避免血栓的形成。血栓的形成、运动及其与血液动力学的关系一直是研究热点，其形成与发展受多种因素影响，如血液壁面剪切力、壁面压强等血流动力学因素和血管内活性生长介质、炎症介质等体液因素。血管中血液流速、黏度、血管形状及血管狭窄等都会对血栓形成、分布和运动产生重要影响。如血管上的附壁血栓，会慢慢钙化甚至导致阻塞血管；而比较小的血栓也会随着血液在人体内流动，在狭窄处阻塞细小血管产生病变。因此，深刻理解血液流体动力学与血栓的相互关系，分析血管壁上壁面剪切力及压力的变化，对预防和治疗血栓具有一定意义。In addition, the design of the rotor structure of the blood pump according to the embodiment of the present invention can also avoid the formation of thrombus. The formation and movement of thrombus and its relationship with hemodynamics have always been research hotspots. The formation and development of thrombus are affected by many factors, such as blood wall shear force, wall pressure and other hemodynamic factors and intravascular active growth media, Humoral factors such as inflammatory mediators. Blood flow velocity, viscosity, vessel shape, and vessel stenosis in blood vessels all have important effects on thrombosis, distribution, and movement. For example, the wall thrombus on the blood vessel will slowly calcify and even lead to blockage of the blood vessel; while the relatively small thrombus will also flow with the blood in the human body, blocking the small blood vessel at the stenosis and causing lesions. Therefore, a deep understanding of the relationship between hemodynamics and thrombus, and analysis of the changes of shear force and pressure on the vascular wall are of great significance for the prevention and treatment of thrombus.
血细胞之间的相互作用，主要是血小板与凝血蛋白之间的相互作用，导致了动脉病变处的血栓形成。该过程通常会引起血管壁表面特性的改变，例如动脉粥样硬化病变。血流紊乱，促凝因子以及血小板数量和血细胞比容的增加可能会加速血栓的形成。考虑血液和血栓之间的相互作用，引入血液(血红细胞和血浆)数学模型，不可压缩流动方程写成：Interactions between blood cells, primarily platelets and coagulation proteins, lead to thrombus formation in arterial lesions. This process often causes changes in the surface properties of the vessel wall, such as atherosclerotic lesions. Blood flow disturbances, procoagulant factors, and increases in platelet count and hematocrit may accelerate thrombus formation. Considering the interaction between blood and thrombus, a mathematical model of blood (red blood cells and plasma) is introduced, and the incompressible flow equation is written as:
其中νf表示血液速度，Tf为流体的应力张量，ρf为血液的密度，bf为体积力νТ，为血栓的速度，C2＝1e9为阻力系数，φ为沉积血小板的体积分数。where νf is the blood velocity, Tf is the stress tensor of the fluid, ρf is the density of the blood, bf is the volume force νТ , is the velocity of the thrombus, C2 =1e9 is the resistance coefficient, and φ is the volume of deposited platelets Fraction.
血栓(血小板)数学模型中，通过对流-扩散-反应方程描述血小板沉积的化学和生物物料反应过程，如下：In the thrombus (platelet) mathematical model, the chemical and biological material reaction process of platelet deposition is described by the convection-diffusion-reaction equation, as follows:
其中，Di指的是血液中物料i的扩散系数，[Ci]为物料i的浓度，Si为物料i的化学反应源项。Among them, Di refers to the diffusion coefficient of the material i in the blood, [Ci ] is the concentration of the materiali , and Si is the chemical reaction source term of the material i.
综上所述，在狭窄处血细胞之间的互相作用是形成血栓的主要原因。而本发明实施例的叶片20结构中，通过柔性部201和硬质部202交叉或部分交叉设置的方式，使血泵转子的叶片20泵送血液时，由于叶片20中使用了柔性材质，可以通过血泵转子的旋转时叶片在根部弯曲，改变叶片与旋转轴角区的大小，这样，血泵转子的叶片20与旋转轴交界的角区这一狭窄位置不会有血液沉积或附着，从而减少血栓在叶片根部与旋转轴交界的角区位置的生成。In conclusion, the interaction between blood cells at the stenosis is the main cause of thrombosis. However, in the structure of the
本发明实施例中，所述柔性部201包括两种以上的不同材质段，所述硬质部 202包括两种以上的不同材质段；所述柔性部201和所述硬质部202沿所述柱形转轴的轴向交替间隔排列分布；如图3、图4所示的血泵转子的叶片结构。In the embodiment of the present invention, the
或者，所述柔性部201和所述硬质部202沿所述柱形转轴10的轴向按材质弹性模量由大到小或由小到大的顺序依次排列分布；即两种以上的不同材质段的柔性部 201和两种以上的不同材质段的硬质部202按各自的弹性模量由大到小或由小到大的顺序依次排列分布。这种基于弹性模量的大小进行排序的叶片，在血泵转子进行血液泵送时，由于叶片是按材质的弹性模量的大小进行排序的，这样，在血泵转子旋转过程中，能够有相对较大的变形，这样，对于血液中的血红细胞进行保护，血泵转子在泵送血液时叶片对血液的成分几乎不会有任何的破坏，从而保证血泵转子在泵送血液时保证血液的各项指标与泵送前一致，保证泵送血液的品质。Alternatively, the
或者，沿所述柱形转轴10的轴向，所述柔性部201位于所述叶片20的两端、所述硬质部202位于所述叶片20的中部而排列分布；参见图6所示的血泵转子的叶片20的结构。本示例中的叶片结构，将硬质部202设置于所述叶片20的中间位置，从而能够使叶片20的整体硬度相对高一些，而能够使血泵转子的泵叶20的泵送效率相对较高，而位于叶片20两端的柔性部201，由于作为血液泵送的主要接触面，即泵叶20两端部分对血液的作用力更大，这样能够对泵送的血液中的相关成分进行保护，避免血红细胞等被血泵转子的叶片20所破坏。Or, along the axial direction of the
或者，沿所述柱形转轴10的轴向，所述硬质部202所位于所述叶片20的两端、所述柔性部201位于所述叶片20的中部而排列分布，参见图5所示的血泵转子的叶片20的结构。本示例中的叶片结构，将硬质部202设置于所述叶片20的两端，从而能够使叶片20的整体硬度相对低一些，而能够使血泵转子的泵叶20在泵送血液时保证血液的血相不被破坏，避免血红细胞等被血泵转子的叶片20所破坏，从而在泵送血液时不会发生溶血现象。Alternatively, along the axial direction of the
本发明实施例中，在考虑血泵转子的泵送效率和对血液的血相进行保护这两个方面来考虑，因此，在制作血泵转子的叶片20时，可以基于柔性部201和硬质部 202的弹性模量，尽量选择弹性模量差异较小的柔性部201和硬质部202；另外，还需要考虑不同材质的柔性部201在血泵转子的转轴轴向的长度占比，以及不同材质的硬质部202在血泵转子的转轴轴向的长度比。In the embodiment of the present invention, the two aspects of the pumping efficiency of the blood pump rotor and the protection of the blood phase of the blood are considered. Therefore, when the
本发明实施例中，制作柔性部201的柔性材质具有一定的弹性要求，该材质具有一定弹性和柔韧性，其中，所述柔性部201的材质的弹性模量为8Mpa至80Mpa；所述硬质部202的材质的弹性模量为35Mpa至195Mpa，所述柔性部201的材质的弹性模量小于所述硬质部202的材质的弹性模量。In the embodiment of the present invention, the flexible material for making the
本发明实施例中，虽然柔性部201的选材中，选用材质的弹性模量越小越好，但也要考虑血泵转子的泵送效率，因此，在满足不对泵送对象例如血液的生理指标造成破坏的前提下，也要保证泵送效率尽可能地高。在对柔性材质的实验过程中，柔性部201的材质的弹性模量优选为45.7Mpa至51.6Mpa。在柔性材质为该弹性模量的区间时，对泵送对象如血液的生理指标破坏较小，且能保证血泵转子的泵送效率。如当采用上述弹性模量为45.7Mpa至51.6Mpa的柔性材质时，本发明实施例的血泵转子的泵送效率，能达到采用全硬质的泵叶片的泵送效率的90.3％，血泵转子的泵送效率下降不明显，而对于泵送的泵送对象如血液而言，在目标方向端的采样中，几乎未见血红细胞的破坏，基本杜绝了溶血的发生。另外，对于目标侧的血液中的白细胞指标、血红蛋白指标、血清结合珠蛋白指标、血小板指标等，均未见有任何的破坏。In the embodiment of the present invention, although the elastic modulus of the material selected for the
另外，对于图3、图4所示的血泵转子的叶片20结构，当柔性部201和硬质部 202之间沿转轴的轴向交叉设置时，相邻的硬质部202与柔性部201之间沿转轴的轴向的长度比最好为1:3至2:9之间，硬质部202在柔性部201之间的占比可以小一些，这样既能保证血泵转子的泵送效率，也能对泵送血液的血相品质进行保护。In addition, for the structure of the
另外，对于图5所示的血泵转子的叶片20结构，当硬质部202设置于叶片20 的两端、而柔性部201设置于叶片20的中间部位时，硬质部202与柔性部201之间沿转轴的轴向的长度比可以大一些，如硬质部202与柔性部201之间沿转轴的轴向的长度比最好为3:5至1:3之间，这样能使血泵转子的泵送效率更大一些。In addition, for the structure of the
另外，对于图6所示的血泵转子的叶片20结构，当硬质部202设置于叶片20 的中间、而柔性部201设置于叶片20的两端时，硬质部202与柔性部201之间沿转轴的轴向的长度比可以小一些，如硬质部202与柔性部201之间沿转轴的轴向的长度比最好为1:4至1:5之间，这样既能保证血泵转子的泵送效率，也能对泵送血液的血相品质进行保护。In addition, for the structure of the
作为一种实现方式，本发明实施例的所述柔性部201包括一种材质段，所述硬质部202包括两种以上的不同材质段；As an implementation manner, the
所述柔性部201夹设于两种以上的不同材质段的所述硬质部202中而分布；这种结构时，叶片20的柔性部201沿转轴的轴向的长度占比可以相对大一些，如硬质部202与柔性部201之间沿转轴的轴向的长度比最好为1:2至1:3。The
或者，所述柔性部201位于两种以上的不同材质段的所述硬质部202的一侧而分布。这种结构时，叶片20的硬质部202与柔性部201之间沿转轴的轴向的长度比最好为1:3至1:4。Alternatively, the
所述柔性部201包括两种以上的材质段，所述硬质部202包括一种材质段。The
所述硬质部202夹设于两种以上的不同材质段的所述柔性部201中而分布；这种结构时，叶片20的硬质部202与柔性部201之间沿转轴的轴向的长度比可以小一些，如最好为1:3至1:5。The
或者，所述硬质部202位于两种以上的不同材质段的所述柔性部201的一侧而分布。这种结构时，叶片20的柔性部201沿转轴的轴向的长度占比可以相对大一些，如硬质部202与柔性部201之间沿转轴的轴向的长度比最好为1:2至1:3。Alternatively, the
作为一种实现方式，本发明实施例中的柔性部201的材质的弹性模量再优选为47.93Mpa至48.67Mpa之间。As an implementation manner, the elastic modulus of the material of the
本发明实施例中，柔性部201的材质并无硬性要求，可以是满足上述弹性模量要求的合金材料，或者为满足上述弹性模量要求的树脂、合成树脂、混合树脂等材质。本发明实施例中，上述柔性部的柔性材质优选为树脂材质。In the embodiment of the present invention, the material of the
本发明实施例中，对于所述硬质部202的材质也无相应要求，只要满足所述硬质部202的材质的弹性模量大于柔性部201的材质的弹性模量。在保证硬质部202 和柔性部201一体加工的条件下，硬质部202的材质的弹性模量与柔性部201的材质的弹性模量之间的差值最好在40Mpa至60Mpa之间。本发明实施例中，当柔性部 201的材质选用树脂时，硬质部202的材质最好也选用硬度更高的树脂等同类材质。当柔性部201的材质选用合金时，硬质部202的材质最好也选用硬度更高的合金或金属等。In the embodiment of the present invention, there is no corresponding requirement for the material of the
本发明实施例中，所述柱形转轴10旋转时，泵送对象能对所述叶片20施加反作用推力，所述叶片20的柔性部201形变而使所述叶片20整体沿反作用推力方向弯曲，泵送对象在弯曲叶片的带动下被泵送至目标方向。In the embodiment of the present invention, when the
本发明实施例中，作为一种实现方式，所述叶片为1至6片。In the embodiment of the present invention, as an implementation manner, the blades are 1 to 6 pieces.
所述叶片20为1片时，所述叶片20从所述柱形转轴10一端的周缘处呈向所述柱形转轴10的另一端运动的方式绕设于所述柱形转轴10的另一端的周缘上；所述叶片20绕设所述柱形转轴10的周缘的周数为0.2至5周。当所述叶片20为1片时，所述叶片20绕设所述柱形转轴10的周缘的周数最好为一周以上，所绕所述柱形转轴10的周缘的周数越多，泵送效率也就越高。When the number of the
需要说明的是，本发明实施例中，虽然叶片20采用了柔性部201的设计方式，但本发明实施例的血泵转子结构中的叶片设计仍需采用普通的血泵转子叶片的设计原理，即需要设置泵输入角度及输出角度等。本发明实施例通过将叶片20采用部分柔性部的设计，可以部分替代血泵转子的叶片的输入角度及输出角度，即与常规的血泵转子叶片的角度相比，可以稍微设计的小一些，以便基于叶片20的柔性部201 的变形，达到与常规血泵转子的叶片的设计完全相同的效果。It should be noted that, in the embodiment of the present invention, although the
作为一种实现方式，本发明实施例中，如图1所示，血泵转子的所述叶片20为 2片至6片时，所述叶片20从所述柱形转轴10一端的周缘处的等分处呈向所述柱形转轴的另一端运动的方式，各叶片20以平行方式绕设于所述柱形转轴10的另一端的周缘的对应等分处；所述叶片20绕设所述柱形转轴的周缘的周数为0.1至5周。As an implementation manner, in the embodiment of the present invention, as shown in FIG. 1 , when the number of the
图7为本发明实施例的血泵转子的叶片柱形转轴设计示意图，如图7所示，确定叶轮外壳直径D2范围小于10mm，本发明实施例取6mm，轮毂比范围大致可为 0.15～0.75，本发明实施例取为0.367，得到叶根直径D1为2.2mm，叶片长度L定义为叶根处叶片长度与外壳直径比值范围大致为1～2，这里取1.333，所以叶片长度为 8mm，叶片出口高度b与外壳直径比值为范围大致为0.25～1.5，本发明实施例取 0.4167，所以出口长度为2.5mm。7 is a schematic diagram of the design of the blade cylindrical shaft of the blood pump rotor according to the embodiment of the present invention. As shown in FIG. 7 , the diameter D2 of the impeller shell is determined to be less than 10 mm, and6 mm in the embodiment of the present invention. 0.75, which is taken as 0.367 in the embodiment of the present invention, the diameter D1of the blade root is 2.2mm, and the length L of the blade is defined as the ratio of the blade length at the blade root to the diameter of the shell, and the range is roughly 1 to 2. Here, 1.333 is taken, so the blade length is 8mm. , the ratio of the blade outlet height b to the shell diameter is roughly in the range of 0.25 to 1.5, and the embodiment of the present invention takes 0.4167, so the outlet length is 2.5 mm.
图8为本发明实施例的血泵转子的叶片角沿程分布图，如图8所示，叶片的出口角度β每一层相同，取与周向夹角范围大致在30°～90°(本发明实施例取60°)。以每一层的进口安装角αm与β，构造叶片角φ沿程分布，叶片角沿轴向从αm至β逐渐变化，获得每一层的叶片中心线，由此获得的叶片绕轴包角每一层可不同，但都不小于90°，所有层上不同包角的差值绝对值最大不超过20°，包角不同的结果为叶片型面是可弯的。Fig. 8 is the distribution diagram of the blade angle along the path of the blood pump rotor according to the embodiment of the present invention. As shown in Fig. 8, the outlet angle β of the blade is the same for each layer, and the included angle with the circumferential direction is approximately in the range of 30° to 90° ( The embodiment of the present invention takes 60°). With the inlet installation angles αm and β of each layer, the blade angle φ is constructed along the route, and the blade angle gradually changes from αm to β along the axial direction, and the center line of the blade of each layer is obtained, and the obtained blade is around the axis. The wrap angle can be different for each layer, but not less than 90°. The absolute value of the difference between different wrap angles on all layers is not more than 20° at most. The result of different wrap angles is that the blade profile is bendable.
在中心线上叠加厚度分布形成每一层上的叶片曲线，每一层的厚度范围不超过1.5mm(本实施例叶根取最大厚度0.8mm，叶尖最大厚度取0.5mm)。将n层叶片曲线积叠获得三维叶片型面，完成叶片设计。The thickness distribution of each layer is superimposed on the center line to form the blade curve on each layer, and the thickness range of each layer is not more than 1.5mm (in this embodiment, the maximum thickness of the blade root is 0.8mm, and the maximum thickness of the blade tip is 0.5mm). The three-dimensional blade profile is obtained by stacking the n-layer blade curves to complete the blade design.
图9为本发明实施例的血泵转子的柱形转轴的设计曲线图，如图9所示，在叶片前缘位置取其前后一段形成长度为l1范围0～4mm(本发明实施例取0.95mm)，距旋转中心距离D1/2不变的直线L1，当l1为0时，曲线始终点重合，在叶片前缘位置处。在L1起始点构造流线型曲线L2，沿轴向向上游距旋转中心距离逐渐从D1/2减小至0，轴向长度l2。在L1下游终止点开始构造曲线L3，沿轴向向下游距旋转中心距离逐渐扩大，在叶片根部达到最大距离D3/2，D3不超过叶片转子直径(本发明实施例中，D3取5.6mm)。在L1下游终止点旋转轴斜向角θ(与轴向夹角)为0°，在最大距离处，旋转轴斜向角θ取范围为20°～90°(取50°)，以这两角度为L3曲线始终点的切线角，轴向长度l3。三条曲线连接后旋转一周获得旋转轴实体，考虑加工精度影响，可以把最大直径圆做成有厚度τ的凸台，厚度不超过0.5mm，旋转轴轴向长度为l1+l2+l3+τ，长度为叶片轴向长度的1.1～2倍(本发明实施例取1.5倍，长度12mm)。完成柱形转轴10设计。Fig. 9 is the design curve diagram of the cylindrical rotating shaft of the blood pump rotor according to the embodiment of the present invention. As shown in Fig. 9 , the front and rear sections of the blade are taken at the leading edge position to form a length of1 in the range of 0 to 4 mm (the embodiment of the present invention takes 0.95mm), a straight line L1 with a constant distance D1 /2 from the rotation center, when l1 is 0, the curve always coincides at the position of the leading edge of the blade. The streamline curve L2 is constructed at the starting point of L1, and the distance from the center of rotation to the upstream in the axial direction gradually decreases from D1 /2 to 0, and the axial length is l2 . The curve L3 is constructed at the downstream end point of L1, and the distance from the rotation center gradually expands downstream in the axial direction, and reaches the maximum distanceD3 /2 at the root of the blade, whereD3 does not exceed the diameter of the rotor of the blade (in the embodiment of the present invention,D3 is taken as 5.6mm). At the downstream termination point of L1, the oblique angle θ of the rotation axis (the included angle with the axial direction) is 0°, and at the maximum distance, the oblique angle θ of the rotation axis ranges from 20° to 90° (takes 50°). The angle is the tangent angle of the constant point of the L3 curve, the axial length l3 . After the three curves are connected, rotate a circle to obtain the entity of the rotating shaft. Considering the influence of machining accuracy, the maximum diameter circle can be made into a boss with a thickness τ, the thickness does not exceed 0.5mm, and the axial length of the rotating shaft is l1 +l2 +l3 +τ, the length is 1.1 to 2 times the axial length of the blade (1.5 times in the embodiment of the present invention, and the length is 12 mm). Complete the design of the
本发明实施例的血泵转子结构，血泵转子的叶片部分采用柔性材质制成，叶片具有柔性部和硬质部，柔性部和硬质部一体平滑连接；叶片的柔性部固定于柱形转轴的周缘上而使叶片分布于柱形转轴的周缘；柔性部的材质的弹性模量小于硬质部的材质的弹性模量。本发明实施例通过对血泵转子的叶片的材质进行相应的选材，使血泵转子在旋转时，使血泵转子的叶片产生形变而弯曲，弯曲的叶片形成血泵转子叶片，将血液泵送至目的方向。本发明实施例中，由于叶片的柔性部固定于柱形转轴的周缘在转子旋转时会沿转动方向受到泵送对象的反作用力而自然变形，从而形成泵的泵叶。另外，由于本发明实施例的血泵转子的叶片部分为柔性材质制成，这样，在泵旋转过程中，血泵转子的叶片在泵送血液时会有弯曲变形，这对于血液的生理指标而言破坏较小，几乎不会破坏血红细胞，因此可保证泵送血液的生理指标，能适用于任何的医疗对象，特别是具有并发症的医疗对象。In the blood pump rotor structure of the embodiment of the present invention, the blade part of the blood pump rotor is made of flexible material, the blade has a flexible part and a hard part, and the flexible part and the hard part are integrated and smoothly connected; the flexible part of the blade is fixed on the cylindrical rotating shaft The blades are distributed on the periphery of the cylindrical shaft; the elastic modulus of the material of the flexible part is smaller than that of the material of the hard part. In the embodiment of the present invention, the material of the blades of the blood pump rotor is selected accordingly, so that when the blood pump rotor rotates, the blades of the blood pump rotor are deformed and bent, and the bent blades form the blades of the blood pump rotor, pumping the blood to the destination direction. In the embodiment of the present invention, since the flexible part of the blade is fixed to the circumference of the cylindrical rotating shaft, it will be naturally deformed by the reaction force of the pumping object along the rotation direction when the rotor rotates, thereby forming the pump blade of the pump. In addition, because the blade part of the blood pump rotor of the embodiment of the present invention is made of flexible material, in this way, during the pump rotation process, the blade of the blood pump rotor will be bent and deformed when pumping blood, which has a negative impact on the physiological indicators of blood. The damage is small, and the red blood cells are hardly destroyed, so the physiological indicators of the pumped blood can be guaranteed, and it can be applied to any medical object, especially the medical object with complications.
此外，本发明的特征和益处通过参考示例性实施例进行说明。相应地，本发明明确地不应局限于这些说明一些可能的非限制性特征的组合的示例性的实施例，这些特征可单独或者以特征的其它组合的形式存在。Furthermore, the features and benefits of the present invention are described with reference to the exemplary embodiments. Accordingly, the invention is expressly not limited to these exemplary embodiments, which illustrate some possible non-limiting combinations of features, which may be present alone or in other combinations of features.
本领域技术人员在考虑说明书及实践这里公开的内容后，将容易想到本发明的其它实施方案。本发明旨在涵盖本发明的任何变型、用途或者适应性变化，这些变型、用途或者适应性变化遵循本发明的一般性原理并包括本发明未公开的本技术领域中的公知常识或惯用技术手段。说明书和实施例仅被视为示例性的，本发明的真正范围和精神以权利要求书为准。Other embodiments of the invention will readily suggest themselves to those skilled in the art upon consideration of the specification and practice of what is disclosed herein. The present invention is intended to cover any variations, uses or adaptations of the present invention which follow the general principles of the present invention and include common knowledge or conventional techniques in the technical field not disclosed by the present invention . The specification and examples are to be regarded as exemplary only, and the true scope and spirit of the invention is to be determined by the claims.
Claims (10)
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| CN202010539721.5ACN111773460A (en) | 2020-06-12 | 2020-06-12 | Blood pump rotor |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111617330A (en)* | 2020-05-27 | 2020-09-04 | 浙江大学 | pump rotor |
| WO2023283250A1 (en)* | 2021-07-07 | 2023-01-12 | Fbr Medical, Inc. | Partially-deformable impeller and catheter blood pump incorporating same |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104984424A (en)* | 2010-07-15 | 2015-10-21 | Ecp发展有限责任公司 | Blood pump for the invasive application within a body of a patient |
| CN212756836U (en)* | 2020-06-12 | 2021-03-23 | 中国医学科学院阜外医院 | Blood pump rotor |
- 2020
- 2020-06-12CNCN202010539721.5Apatent/CN111773460A/enactivePending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104984424A (en)* | 2010-07-15 | 2015-10-21 | Ecp发展有限责任公司 | Blood pump for the invasive application within a body of a patient |
| CN212756836U (en)* | 2020-06-12 | 2021-03-23 | 中国医学科学院阜外医院 | Blood pump rotor |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111617330A (en)* | 2020-05-27 | 2020-09-04 | 浙江大学 | pump rotor |
| WO2023283250A1 (en)* | 2021-07-07 | 2023-01-12 | Fbr Medical, Inc. | Partially-deformable impeller and catheter blood pump incorporating same |
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