WO2023280245A1 - 一种心脏辅助装置的叶轮及心脏辅助装置 - Google Patents

一种心脏辅助装置的叶轮及心脏辅助装置 Download PDF

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Publication number
WO2023280245A1
WO2023280245A1 PCT/CN2022/104252 CN2022104252W WO2023280245A1 WO 2023280245 A1 WO2023280245 A1 WO 2023280245A1 CN 2022104252 W CN2022104252 W CN 2022104252W WO 2023280245 A1 WO2023280245 A1 WO 2023280245A1
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WIPO (PCT)
Prior art keywords
impeller
assist device
blade
angle
heart assist
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PCT/CN2022/104252
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English (en)
French (fr)
Inventor
杨云骢
刘曦
王海山
虞奇峰
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上海焕擎医疗科技有限公司
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Priority to EP22836990.6A priority Critical patent/EP4344727A1/en
Publication of WO2023280245A1 publication Critical patent/WO2023280245A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades

Definitions

  • the invention relates to the technical field of medical devices, in particular to an impeller of a heart assist device and the heart assist device.
  • Percutaneous ventricular assist device is a newer product compared to traditional ventricular assist devices or cardiac blood pumps. Its main advantage is that it does not require chest surgery and can be implanted into the heart through minimally invasive methods such as femoral artery puncture or incision. , greatly reducing the risk of surgery. This advantage allows it to be used to maintain the vital signs of patients with severe heart failure, or as an adjuvant treatment in high-risk PCI operations to reduce surgical risks.
  • the size of the percutaneous ventricular assist device needs to be smaller than that of traditional ventricular assist devices to meet the needs of passing through the femoral artery and aorta smoothly.
  • the outer diameter of the percutaneous ventricular assist device needs to be less than 21Fr/7mm.
  • the axial flow pump has a built-in impeller that can pump blood from the left ventricle to the aorta at high speed, so the impeller plays a very important role.
  • the impeller is located in the pump box which is consistent with the outer diameter of the product, so the size of the impeller is smaller than the outer diameter of the product.
  • the diameter of the impeller is less than 6mm.
  • existing impellers cannot meet the requirements of miniature size and achieve sufficient flow to help ventricular assist devices maintain the patient's vital signs.
  • the invention discloses an impeller of a heart assist device and the heart assist device, which are used to solve the problem that the impeller of the heart assist device cannot meet the requirements of miniature size in the prior art, and can also achieve sufficient flow to help the ventricular assist device maintain the patient's Questions about vital signs.
  • the present invention adopts the following technical solutions:
  • An impeller for a cardiac assist device comprising an impeller shaft and blades;
  • the shape of the blade is set as follows: the cascade of the blade is in the shape of an arc concave to the same side, and the cascade conforms to the function:
  • r * is the radius of the cylinder where the function is located
  • ⁇ is the angular strain
  • z is the axial strain
  • t is the independent variable
  • a and b are the coefficients
  • the cascade is the The planar unfolded shape of the intersection line where the face intersects the blade.
  • the rotational speed of the impeller is 30000-90000 RPM.
  • the value range of the coefficient b is 20-78.
  • the rotational speed of the impeller is 35000 RPM.
  • the value of the coefficient b is 60.
  • the coefficient a is positively correlated with the flow rate of the impeller.
  • the flow rate of the impeller is 4L/min.
  • the value of the coefficient a is 3.5.
  • the outer diameter of the impeller is 5mm.
  • the diameter of the middle part of the impeller shaft is 2.5 mm, and the hub ratio is 0.5.
  • the axial length of the blade is equal to the height of the cascade, and neither exceeds 6mm.
  • the inflow end and the outflow end of the cascade are respectively connected by a first straight line and a second straight line
  • the included angle between the first straight line and the first tangent line of the first arc is a first angle
  • the included angle between the second straight line and the second tangent of the second arc is a second angle
  • the range of the first angle is 10°-20°
  • the range of the second angle is 40°-50° .
  • the blades are two pieces.
  • the inflow end of the impeller shaft is a cone
  • the middle part is a cylinder
  • the outflow end is an inwardly concave arc surface
  • the present invention also provides a heart assist device, including the impeller described in any one of the above schemes, and further including:
  • the sleeve is arranged on the outer circumference of the cannula, the impeller and the motor, the end of the sleeve close to the cannula is an inflow chamber, and the end close to the motor is an outflow chamber.
  • the arc at the tail of the impeller is continuous with the arc at the front of the motor.
  • the traditional airfoil cascade is changed, and the cascade is curved to the same side.
  • This design makes the blood pass through the impeller with a smaller inflow angle and a larger outflow angle.
  • the smaller the inflow angle can produce the larger head, so that the impeller can obtain greater output power, and at the same time, it can avoid the rotating flow at the inflow port, so that the blood can flow into the impeller stably.
  • a larger outflow angle can convert the rotational energy of the blood at the outflow port into axial kinetic energy to obtain a greater axial velocity and improve the efficiency of the impeller.
  • Fig. 1 is a side view of the impeller of the heart assist device disclosed in Embodiment 1 of the present invention
  • Fig. 2 is a schematic diagram of another perspective of the impeller of the heart assist device disclosed in Embodiment 1 of the present invention.
  • Fig. 3 is a schematic diagram of the cascade of the heart assist device disclosed in Embodiment 1 of the present invention.
  • Fig. 5 is a linear relationship diagram between the flow rate and the coefficient a of the impeller disclosed in Embodiment 1 of the present invention.
  • Fig. 6 is a schematic diagram of the overall structure of the heart assist device disclosed in Embodiment 2 of the present invention.
  • Fig. 7 is an enlarged view of the internal structure at A of Fig. 4;
  • Fig. 8 is a schematic diagram of the connection between the impeller and the motor of the heart assist device disclosed in Embodiment 2 of the present invention.
  • Impeller-10 motor-20; blade-11; impeller shaft-12; cascade-13.
  • the impeller of the heart assist device includes an impeller shaft 12 and blades 11;
  • the shape of the blade 11 is set as follows: the cascade 13 of the blade 11 is in the shape of an arc concave to the same side, and the cascade 13 conforms to the function:
  • r * is the radius of the cylinder where the function is located, ⁇ is the angular strain, z is the axial strain, t is the independent variable, and 0 ⁇ ? ⁇ 1, a and b are coefficients; the cascade 13 is the plane expanded shape of the intersection line between the cylinder and the blade 11 .
  • the present invention changes the traditional airfoil cascade.
  • the cascade 13 is designed in a concave arc shape to the same side. This design makes the blood pass through the impeller 10 with a smaller inflow angle and a larger outflow angle. The smaller the inflow The angle can generate a larger head, so that the impeller 10 can obtain greater output power, and can also prevent the inflow port from generating swirling flow, so that the blood can flow into the impeller 10 stably.
  • a larger outflow angle can convert the rotational energy of the blood at the outflow port into axial kinetic energy to obtain a greater axial velocity and improve the efficiency of the impeller 10 .
  • t represents an abstract concept of time.
  • the axial strain z is 0 to represent the initial position of the blade 11.
  • the value of the axial strain z is the axial length of the blade 11 .
  • the coefficient b is mainly related to the rotational speed of the impeller 10 and the radius of the impeller 10 , and there is an arccosine relationship.
  • the coefficient b is a real value, and the corresponding value range is 20-78.
  • the rotational speed of the impeller 10 is 35000 RPM.
  • the value of coefficient b is 60.
  • the coefficient a is positively correlated with the flow rate of the impeller 10 . Therefore, after calculating the value of the coefficient b at a fixed rotational speed, the mathematical relationship between the coefficient a and the flow rate of the impeller 10 can be obtained. Under the specific rotation speed of the impeller 10 and the corresponding value of the coefficient b, there is a linear relationship between the coefficient a and the flow rate of the impeller 10 in mathematics. In this embodiment, preferably, the flow rate is 4.0 L/min, and the value of the coefficient a is about 3.5.
  • the outer diameter of the impeller 10 is 5mm.
  • the diameter of the middle part of the impeller shaft 12 is 2.5mm, and the hub ratio is 0.5.
  • the value of z brought in is the axial length of the blade 11 and the height of the cascade 13, which is preferably about 6 mm in this embodiment.
  • the inflow end and the outflow end of the cascade 13 are respectively connected by a first straight line and a second straight line, the angle between the first straight line and the first tangent of the first arc is ⁇ , and the angle between the second straight line and the second arc is The included angle of the second tangent is ⁇ , ⁇ ranges from 10° to 20°, and ⁇ ranges from 40° to 50°.
  • the inflow end of the impeller shaft 12 is a cone, the middle part is a cylinder, and the outflow end is an inwardly concave arc surface; the inflow end of the impeller shaft 12 is a cone so that the blood flow can flow into the impeller 10 smoothly,
  • the side surface of the outflow end is an inwardly concave arc surface so that the blood flow can pass along the arc.
  • the projection of the outer edge of the blade 11 at the center of the impeller shaft 12 is always perpendicular to the axis of the impeller shaft 12.
  • the present invention also discloses a heart assist device, including the impeller 10 in Embodiment 1, and further including:
  • the intubation tube is connected with the inflow end of the impeller 10; the motor 20 is connected with the outflow end of the impeller 10; One end of the motor 20 is an outflow chamber.
  • the arc at the tail of the impeller 10 is continuous with the arc at the front of the motor 20 . It is ensured that the blood flow passes along the arc, and can flow on the surface of the motor 20 after flowing out from the impeller 10 , thereby cooling the surface of the motor 20 through the flow of blood.
  • the present invention changes the traditional airfoil cascade.
  • the cascade is curved to the same side.
  • This design makes the blood flow through the impeller with a smaller inflow angle and a larger outflow angle.
  • the smaller the inflow angle can produce The larger the lift, the greater the output power of the impeller, and at the same time, it can avoid the rotating flow at the inflow port, so that the blood can flow into the impeller stably.
  • a larger outflow angle can convert the rotational energy of the blood at the outflow port into axial kinetic energy to obtain a greater axial velocity and improve the efficiency of the impeller.

Abstract

本发明公开了一种心脏辅助装置的叶轮及心脏辅助装置，其中，心脏辅助装置的叶轮包括，叶轮轴和叶片；叶片的形状被设置为：叶片的叶栅为向同侧凹陷的弧线形，叶栅为柱面与叶片相交的交线的平面展开形状。本发明改变了传统的翼型叶栅，叶栅为向同侧凹陷的弧线形，这种设计使得血液经过叶轮具有更小的流入角和更大的流出角，越小的流入角可以产生越大的扬程，从而使叶轮获得更大的输出功率，同时也可以避免流入口产生旋转流，使血液稳定流入叶轮。更大的流出角可以将血液在流出口的旋转能转化为轴向动能从而获得更大的轴向速度，提高叶轮的效率。

Description

一种心脏辅助装置的叶轮及心脏辅助装置 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种心脏辅助装置的叶轮及心脏辅助装置。
背景技术
经皮心室辅助装置对于传统心室辅助装置或者心脏血泵是一种更新型的产品，它的主要优势在于无需经过开胸手术植入，可通过股动脉穿刺或切开等微创方式植入心脏，大大降低手术风险。这种优势使它可以用于维持严重心衰患者的生命体征，或是在高风险PCI手术中辅助治疗，降低手术风险。但是由于需要经由股动脉植入左心室，比起传统心室辅助装置，经皮心室辅助装置的尺寸需要更小，满足能顺利通过股动脉和主动脉的需求。通常经皮心室辅助装置的外径需要小于21Fr/7mm。轴流泵作为心室辅助的核心组件，内置叶轮在高速转速下能够起到将血液从左心室泵入主动脉的功能，因此叶轮的作用至关重要。根据专利文件US9872948B2公开的心内泵送装置，叶轮位于和产品外径一致的泵箱内，因此叶轮的尺寸比产品外径更小。通常来说，叶轮的直径小于6mm。但是，现有的叶轮，无法既满足微型尺寸的要求，又能达到足够的流量帮助心室辅助装置维持患者的生命体征。
有鉴于此，急需对现有的心脏辅助装置的叶轮进行改进，既满足微型尺寸的要求，又能达到足够的流量帮助心室辅助装置维持患者的生命体征。
发明内容
本发明公开一种心脏辅助装置的叶轮及心脏辅助装置，用于解决现有技术中，心脏辅助装置的叶轮无法，既满足微型尺寸的要求，又能达到足够的流量帮助心室辅助装置维持患者的生命体征的问题。
为了解决上述问题，本发明采用下述技术方案：
提供一种心脏辅助装置的叶轮，包括，叶轮轴和叶片；
所述叶片的形状被设置为：所述叶片的叶栅为向同侧凹陷的弧线形，所述叶栅符合函数：
Figure PCTCN2022104252-appb-000001
其中，r *为函数所在柱面半径，θ为角度应变量，z为轴向应变量，t为自变量，且0≤t≤1，a与b为系数；所述叶栅为所述柱面与所述叶片相交的交线的平面展开形状。
在上述方案中，所述叶轮的转速和所述叶轮的半径与系数b存在反余弦关系。
在上述方案中，所述叶轮的转速为30000～90000RPM。
在上述方案中，所述系数b的取值范围为20～78。
在上述方案中，所述叶轮的转速为35000RPM。
在上述方案中，所述系数b的取值为60。
在上述方案中，系数a与所述叶轮的流量正相关。
在上述方案中，所述叶轮的流量为4L/min。
在上述方案中，所述系数a的取值为3.5。
在上述方案中，所述叶轮的外径为5mm。
在上述方案中，所述叶轮轴中间部分的直径为2.5mm，轮毂比为0.5。
在上述方案中，所述叶片的函数方程式为：
Figure PCTCN2022104252-appb-000002
在上述方案中，所述叶片的轴向长度与所述叶栅的高度相等，均不超过6mm。
在上述方案中，所述叶栅的流入端和流出端分别通过第一直线和第二直线连接，所述第一直线与第一弧线的第一切线的夹角为第一角度，所述第二直线与第二弧线的第二切线的夹角为第二角度，所述第一角度的范围为10°～20°，所述第二角度的范围为40°～50°。
在上述方案中，所述叶片为两片。
在上述方案中，所述叶轮轴的流入端为圆锥体，中间部分为圆柱体，流出端为向内凹陷的弧面。
本发明还提供了一种心脏辅助装置，包括上述方案中任一项所述的叶轮，还包括：
插管，与所述叶轮的流入端连接；
马达，与所述叶轮的流出端连接；
套管，设置在所述插管、所述叶轮和所述马达的外周，所述套管靠近所述插管的一端为流入室，靠近所述马达的一端为流出室。
在上述方案中，所述叶轮的尾部的弧线与所述马达的前端的弧线具有连续性。
本发明采用的技术方案能够达到以下有益效果：
改变了传统的翼型叶栅，叶栅为向同侧凹陷的弧线形，这种设计使得血液经过叶轮具有更小的流入角和更大的流出角，越小的流入角可以产生越大的扬程，从而使叶轮获得更 大的输出功率，同时也可以避免流入口产生旋转流，使血液稳定流入叶轮。更大的流出角可以将血液在流出口的旋转能转化为轴向动能从而获得更大的轴向速度，提高叶轮的效率。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，构成本发明的一部分，本发明的示意性实施例及其说明解释本发明，并不构成对本发明的不当限定。在附图中：
图1为本发明实施例1公开的心脏辅助装置的叶轮的侧视图；
图2为本发明实施例1公开的心脏辅助装置的叶轮的另一视角的示意图；
图3为本发明实施例1公开的心脏辅助装置的叶栅示意图；
图4为本发明实施例1公开的叶轮的转速和系数b的关系曲线图；
图5为本发明实施例1公开的叶轮的流量和系数a的线性关系图；
图6为本发明实施例2公开的心脏辅助装置的整体结构示意图；
图7为图4的A处的内部结构放大图；
图8为本发明实施例2公开的心脏辅助装置的叶轮与马达连接的示意图。
具体包括下述附图标记：
叶轮-10；马达-20；叶片-11；叶轮轴-12；叶栅-13。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明具体实施例及相应的附图对本发明技术方案进行清楚、完整地描述。显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
如图1～3所示，本发明提供的心脏辅助装置的叶轮，包括，叶轮轴12和叶片11；
叶片11的形状被设置为：叶片11的叶栅13为向同侧凹陷的弧线形，叶栅13符合函数：
Figure PCTCN2022104252-appb-000003
式中：r *为函数所在柱面半径，θ为角度应变量，z为轴向应变量，t为自变量，且0≤？≤1，a与b为系数；叶栅13为柱面与叶片11相交的交线的平面展开形状。
本发明改变了传统的翼型叶栅，叶栅13为向同侧凹陷的弧线形设计，这种设计使得血 液经过叶轮10具有更小的流入角和更大的流出角，越小的流入角可以产生越大的扬程，从而使叶轮10获得更大的输出功率，同时也可以避免流入口产生旋转流，使血液稳定流入叶轮10。更大的流出角可以将血液在流出口的旋转能转化为轴向动能从而获得更大的轴向速度，提高叶轮10的效率。
本实施例中，t表示一个抽象的时间概念，当t＝0时，轴向应变量z为0表示叶片11的起始位置，当t＝1时，表示经过叶片11的时间为单位1，此时，轴向应变量z的值为叶片11的轴向长度。
如图4所示，通过建立数学模型，系数b主要与叶轮10的转速和叶轮10的半径有关，存在反余弦关系。当叶轮10的转速在30000～90000RPM的取值范围时，系数b为实数值，对应的取值范围为20～78。
本实施例优选的，叶轮10的转速为35000RPM。系数b的取值为60。
如图5所示，系数a与叶轮10的流量正相关。因此，在固定的转速下求出系数b的值后，可以得出系数a与叶轮10流量的数学关系。在特定叶轮10的转速和相对应的系数b的值下，系数a与叶轮10的流量在数学上存在线性关系。本实施例优选的，流量为4.0L/min，系数a的取值约为3.5。
本实施例优选的，叶轮10的外径为5mm。叶轮轴12中间部分的直径为2.5mm，轮毂比为0.5。
将系数a和系数b带入本实施例优选的取值后，叶片11的函数方程式为：
Figure PCTCN2022104252-appb-000004
当t＝1时，带入z的值为叶片11的轴向长度也是叶栅13的高度，本实施例优选的，约为6mm。
叶栅13的流入端和流出端分别通过第一直线和第二直线连接，第一直线与第一弧线的第一切线的夹角为α，第二直线与第二弧线的第二切线的夹角为β，α的范围为10°～20°，β的范围为40°～50°。
本实施例优选的，叶片11为两片。
本实施例优选的，叶轮轴12的流入端为圆锥体，中间部分为圆柱体，流出端为向内凹陷的弧面；叶轮轴12的流入端为圆锥体使血流能够顺利流入叶轮10，流出端的侧面为向内凹陷的弧面使血流能够沿弧线通过。
本实施例优选的，叶片11的外沿在叶轮轴12的轴心处的投影始终与叶轮轴12的轴线 垂直。
实施例2
如图6～8所示，本发明还公开了一种心脏辅助装置，包括实施例1中的叶轮10，还包括：
插管，与叶轮10的流入端连接；马达20，与叶轮10的流出端连接；套管，设置在插管、叶轮10和马达20的外周，套管靠近插管的一端为流入室，靠近马达20的一端为流出室。
优选的，叶轮10的尾部的弧线与马达20的前端的弧线具有连续性。保证了血流沿弧线通过，从叶轮10流出后能在马达20表面流动，从而通过血液的流动为马达20的表面降温。
本发明改变了传统的翼型叶栅，叶栅为向同侧凹陷的弧线形，这种设计使得血液经过叶轮具有更小的流入角和更大的流出角，越小的流入角可以产生越大的扬程，从而使叶轮获得更大的输出功率，同时也可以避免流入口产生旋转流，使血液稳定流入叶轮。更大的流出角可以将血液在流出口的旋转能转化为轴向动能从而获得更大的轴向速度，提高叶轮的效率。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，均属于本发明的保护之内。

Claims (18)

  1. 一种心脏辅助装置的叶轮，其特征在于，包括，叶轮轴和叶片；
    所述叶片的形状被设置为：所述叶片的叶栅为向同侧凹陷的弧线形，所述叶栅符合函数：
    Figure PCTCN2022104252-appb-100001
    其中，r *为函数所在柱面半径，θ为角度应变量，z为轴向应变量，t为自变量，且0≤t≤1，a与b为系数；所述叶栅为所述柱面与所述叶片相交的交线的平面展开形状。
  2. 根据权利要求1所述的心脏辅助装置的叶轮，其特征在于，所述叶轮的转速和所述叶轮的半径与系数b存在反余弦关系。
  3. 根据权利要求2所述的心脏辅助装置的叶轮，其特征在于，所述叶轮的转速为30000～90000RPM。
  4. 根据权利要求3所述的心脏辅助装置的叶轮，其特征在于，所述系数b的取值范围为20～78。
  5. 根据权利要求2所述的心脏辅助装置的叶轮，其特征在于，所述叶轮的转速为35000RPM。
  6. 根据权利要求5所述的心脏辅助装置的叶轮，其特征在于，所述系数b的取值为60。
  7. 根据权利要求6所述的心脏辅助装置的叶轮，其特征在于，系数a与所述叶轮的流量正相关。
  8. 根据权利要求7所述的心脏辅助装置的叶轮，其特征在于，所述叶轮的流量为4L/min。
  9. 根据权利要求8所述的心脏辅助装置的叶轮，其特征在于，所述系数a的取值为3.5。
  10. 根据权利要求9所述的心脏辅助装置的叶轮，其特征在于，所述叶轮的外径为5mm。
  11. 根据权利要求10所述的心脏辅助装置的叶轮，其特征在于，所述叶轮轴中间部分的直径为2.5mm，轮毂比为0.5。
  12. 根据权利要求11所述的心脏辅助装置的叶轮，其特征在于，所述叶片的函数方程式为：
    Figure PCTCN2022104252-appb-100002
  13. 根据权利要求12所述的心脏辅助装置的叶轮，其特征在于，所述叶片的轴向长度与所述叶栅的高度相等，均不超过6mm。
  14. 根据权利要求12所述的心脏辅助装置的叶轮，其特征在于，所述叶栅的流入端和流出端分别通过第一直线和第二直线连接，所述第一直线与第一弧线的第一切线的夹角为第一角度，所述第二直线与第二弧线的第二切线的夹角为第二角度，所述第一角度的范围为10°～20°，所述第二角度的范围为40°～50°。
  15. 根据权利要求12所述的心脏辅助装置的叶轮，其特征在于，所述叶片为两片。
  16. 根据权利要求1所述的心脏辅助装置的叶轮，其特征在于，所述叶轮轴的流入端为圆锥体，中间部分为圆柱体，流出端为向内凹陷的弧面。
  17. 一种心脏辅助装置，其特征在于，包括权利要求1-16任一项所述的叶轮，还包括：
    插管，与所述叶轮的流入端连接；
    马达，与所述叶轮的流出端连接；
    套管，设置在所述插管、所述叶轮和所述马达的外周，所述套管靠近所述插管的一端为流入室，靠近所述马达的一端为流出室。
  18. 根据权利要求17所述的心脏辅助装置，其特征在于，所述叶轮的尾部的弧线与所述马达的前端的弧线具有连续性。
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