CN114010937B - Catheter pump and impeller and pump body thereof - Google Patents

Abstract

Translated fromChinese

公开一种导管泵及其叶轮、泵体；叶轮能够容纳在导管泵的泵壳内，包括轮毂以及设于轮毂上的叶片；叶片具有设置于轮毂上的叶根、远离轮毂的叶顶以及位于叶根和叶顶之间的反折部；叶根在径向上沿第一周向朝向反折部倾斜延伸，反折部在径向上沿与第一周向相反的第二周向朝向叶片的叶顶倾斜延伸。

Disclosed is a catheter pump, its impeller, and pump body; the impeller can be accommodated in the pump casing of the catheter pump, and includes a hub and blades arranged on the hub; the blade has a blade root arranged on the hub, a blade top away from the hub, and a The reflex portion between the blade root and the blade tip; the blade root extends obliquely toward the reflex portion along the first circumferential direction in the radial direction, and the reflex portion extends radially toward the blade along the second circumferential direction opposite to the first circumferential direction Leaf tops extend obliquely.

Description

Translated fromChinese

导管泵及其叶轮、泵体Catheter pump and its impeller, pump body

技术领域technical field

本公开涉及医疗器械领域，特别地涉及一种心脏辅助用途的设备，更特别地涉及一种导管泵及其叶轮、泵体。The present disclosure relates to the field of medical devices, in particular to a device for assisting the heart, and more particularly to a catheter pump and its impeller and pump body.

背景技术Background technique

介入式导管泵装置(简称血泵)可以泵送血液。以左心室辅助为例，现有技术一般将介入式导管泵装置的泵设在受试者体的左心室内，通过一个软轴带动该泵的叶轮旋转，通过电机驱动该软轴，向泵传递动力。Interventional catheter pump devices (referred to as blood pumps) can pump blood. Taking left ventricular assistance as an example, in the prior art, the pump of the interventional catheter pump device is generally installed in the left ventricle of the subject, and a flexible shaft is used to drive the impeller of the pump to rotate, and the flexible shaft is driven by a motor to drive the pump to the pump. Deliver momentum.

现有导管泵为了确保稳定的收缩和扩张，使其能够插入到患者的血管并可在插入后扩张。在压缩和扩张的过程中，转子(例如叶轮)和外壳通常都会相应的变形，而叶顶隙尺寸(也称泵间隙，即叶轮的径向外端与泵体外壳的内壁之间的间隔间隙)的稳定性是血泵工作稳定性的一个重要影响因素。经过仿真分析，泵体外部支架(外壳)的尺寸变化很小，对于顶隙影响最大即是叶轮外径的变化。Existing catheter pumps can be inserted into a patient's blood vessel in order to ensure stable contraction and expansion, and can be expanded after insertion. In the process of compression and expansion, the rotor (such as the impeller) and the casing are usually deformed accordingly, and the size of the tip clearance (also known as the pump gap, that is, the gap between the radially outer end of the impeller and the inner wall of the pump casing) ) stability is an important factor affecting the stability of blood pump work. After simulation analysis, the size change of the external support (shell) of the pump body is very small, and the change of the outer diameter of the impeller has the greatest impact on the top clearance.

随着转速的增高，叶轮外径会持续增大，叶轮外径的持续增大会使水力学性能会迅速提高，而水力学性能的提高会反向推动叶轮直径的增大，这就导致叶轮稳定高效工作的范围很小，对于泵的效能产生消极影响。As the speed increases, the outer diameter of the impeller will continue to increase, and the continuous increase in the outer diameter of the impeller will rapidly increase the hydraulic performance, and the increase in hydraulic performance will reverse the increase in the diameter of the impeller, which leads to a stable impeller. The efficient operating range is small, which negatively affects the pump's performance.

再者，随着转速的增大，叶轮外径的持续增大很容易超过设计工作点，导致叶轮与支架产生刮擦，血泵工作失效。Furthermore, with the increase of the rotating speed, the continuous increase of the outer diameter of the impeller can easily exceed the design working point, resulting in scratches between the impeller and the bracket, and the failure of the blood pump.

发明内容Contents of the invention

鉴于上述不足，本公开的一个目的是提供一种能够降低叶轮在工作转动过程中的外径变化量的导管泵及其叶轮、泵体。In view of the above disadvantages, an object of the present disclosure is to provide a catheter pump, its impeller, and a pump body that can reduce the variation of the outer diameter of the impeller during operation and rotation.

本公开还有一个目的提供一种能够稳定地保持泵间隙的导管泵及其叶轮、泵体。Another object of the present disclosure is to provide a catheter pump, its impeller, and pump body capable of stably maintaining the pump clearance.

为达到上述至少一个目的，本发明采用如下技术方案：In order to achieve at least one of the above objectives, the present invention adopts the following technical solutions:

一种导管泵用叶轮，所述叶轮能够容纳在所述导管泵的泵壳内旋转，包括轮毂以及设置于轮毂上的叶片。叶片具有叶顶、设置于轮毂上的叶根以及位于叶根和叶顶之间的反折部。叶根在径向上沿第一周向朝向反折部倾斜延伸，反折部在径向上沿与第一周向相反的第二周向朝向叶片的叶项倾斜延伸。第一周向与叶轮旋转方向相反。An impeller for a catheter pump, the impeller can be accommodated and rotated in a pump casing of the catheter pump, including a hub and blades arranged on the hub. The blade has a blade top, a blade root arranged on the hub, and a reflex portion located between the blade root and the blade top. The blade root obliquely extends radially along the first circumferential direction toward the reflexion portion, and the reflexion portion extends obliquely toward the tip of the blade along a second circumferential direction opposite to the first circumferential direction in the radial direction. The first circumferential direction is opposite to the direction of rotation of the impeller.

优选的，叶轮具有不旋转时的自然展开状态和对应最大工作转速旋转时的工作状态。叶轮从自然展开状态切换至工作状态，叶顶的外径(叶轮外径)变化量小于0.5mm，优选小于0.3mm，更进一步优选小于0.1mm。进一步地，叶轮在工作状态下从最小工作转速切换至最大工作转速时，叶顶的外径变化量小于0.3mm，更进一步优选的小于0.1mm。Preferably, the impeller has a natural unfolding state when not rotating and a working state when rotating corresponding to the maximum working speed. When the impeller is switched from the naturally unfolded state to the working state, the change in the outer diameter of the blade tip (the outer diameter of the impeller) is less than 0.5 mm, preferably less than 0.3 mm, and more preferably less than 0.1 mm. Further, when the impeller is switched from the minimum operating speed to the maximum operating speed in the working state, the variation of the outer diameter of the blade tip is less than 0.3mm, more preferably less than 0.1mm.

优选的，叶片包括位于叶根与反折部之间的第一部分、位于反折部和叶顶之间的第二部分。第一部分的径向长度La大于0.5倍的第二部分的径向长度，优选的，第一部分的径向La大于第二部分的径向长度。Preferably, the blade includes a first portion located between the blade root and the reflex portion, and a second portion located between the reflex portion and the blade tip. The radial length La of the first portion is greater than 0.5 times the radial length of the second portion. Preferably, the radial length La of the first portion is greater than the radial length of the second portion.

优选的，叶片包括位于叶根与反折部之间的第一部分、位于反折部和叶顶之间的第二部分。叶片具有相背对的内凹迎流面以及外凸背流面，第二部分的最大厚度大于0.7倍的第一部分的最大厚度，进一步地，第二部分的最大厚度大于第一部分的最大厚度。其中，厚度方向为内凹迎流面或外凸背流面在横截面上的轮廓线的法线方向。Preferably, the blade includes a first portion located between the blade root and the reflex portion, and a second portion located between the reflex portion and the blade tip. The blade has opposite concave upflow surfaces and convex backflow surfaces. The maximum thickness of the second part is greater than 0.7 times the maximum thickness of the first part. Further, the maximum thickness of the second part is greater than the maximum thickness of the first part. Wherein, the thickness direction is the normal direction of the contour line of the concave upflow surface or the convex backflow surface on the cross section.

优选的，叶片包括位于叶根与反折部之间的第一部分、位于反折部和叶顶之间的第二部分。第一部分的横截面积在第二部分的横截面积的0.5倍以上，优选0.8倍以上。Preferably, the blade includes a first portion located between the blade root and the reflex portion, and a second portion located between the reflex portion and the blade tip. The cross-sectional area of the first portion is at least 0.5 times, preferably at least 0.8 times, that of the second portion.

优选的，在叶片的一横截面上，叶片包括位于叶根与反折部之间的第一部分、位于反折部和叶顶之间的第二部分。反折部的切线穿过轮毂的圆心；第一部分在垂直于切线方向上的长度在第二部分垂直于切线方向上的长度的0.3倍以上，优选的，0.5倍以上。Preferably, in a cross section of the blade, the blade includes a first part located between the blade root and the reflex part, and a second part located between the reflex part and the blade tip. The tangent of the reflexed portion passes through the center of the hub; the length of the first part in the direction perpendicular to the tangent is at least 0.3 times, preferably at least 0.5 times, the length of the second part in the direction perpendicular to the tangent.

优选的，叶片包括位于叶根与反折部之间的第一部分、位于反折部和叶顶之间的第二部分；叶片具有相背对的内凹迎流面以及外凸背流面；其中，位于第一部分的内凹迎流面或外凸迎流面上的任意点，定义该任意点的切线具有一远离第二部分方向的切线向量

该任意点的切线与轮毂的外轮廓线存在一接触点，定义轮毂的圆心具有朝向接触点的射线向量

切线向量

和射线向量

之间的夹角β大于90度且小于180度。Preferably, the blade includes a first part located between the root of the blade and the reflexion part, and a second part located between the reflexion part and the tip of the blade; the blade has a concave inner flow facing surface and an outer convex backflow surface opposite to each other; Wherein, at any point on the concave inflow surface or the convex outflow surface of the first part, the tangent defining the arbitrary point has a tangent vector away from the direction of the second part

There is a point of contact between the tangent of this arbitrary point and the outer contour of the hub, and the center of the circle defining the hub has a ray vector towards the contact point

tangent vector

and ray vector

The angle β between them is greater than 90 degrees and less than 180 degrees.

优选的，位于第一部分的内凹迎流面或外凸迎流面上的位置点越靠近反折部其β角越大。优选的，叶根在内凹迎流面和轮毂之间设有圆弧过渡部，和/或，叶根在外凹迎流面和轮毂之间设有圆弧过渡部。Preferably, the angle β becomes larger as the position on the concave inflow surface or the convex inflow surface of the first part is closer to the reflex portion. Preferably, the blade root is provided with a circular arc transition portion between the inner concave incoming flow surface and the hub, and/or, the blade root is provided with a circular arc transition portion between the outer concave incoming flow surface and the hub.

一种导管泵用叶轮，叶轮能够容纳在导管泵的泵壳内旋转，包括轮毂以及设置于轮毂上的叶片。叶片具有叶顶、设置于轮毂上的叶根以及位于叶根和叶顶之间的反折部。在叶片具有最大外径的横截面上，叶片的叶根在径向上沿与叶轮旋转方向相反的第一周向朝向反折部倾斜延伸；反折部在径向上沿与第一周向相反的第二周向朝向叶片的叶顶倾斜延伸。Disclosed is an impeller for a catheter pump, which can be accommodated and rotated in a pump casing of the catheter pump, and includes a hub and blades arranged on the hub. The blade has a blade top, a blade root arranged on the hub, and a reflex portion located between the blade root and the blade top. On the cross-section of the blade with the largest outer diameter, the blade root of the blade extends obliquely toward the reflex portion in the radial direction along the first circumferential direction opposite to the rotation direction of the impeller; the reflex portion extends radially along the direction opposite to the first circumferential direction The second circumferential direction extends obliquely towards the tip of the blade.

一种导管泵用叶轮，叶轮能够容纳在导管泵的泵壳内旋转；叶轮包括轮毂以及设置于轮毂上的叶片。叶片叶顶、具有设置于轮毂上的叶根。叶轮在工作状态下从最小工作转速切换至最大工作转速时，叶顶的外径变化量小于0.3mm。更进一步地，叶顶的外径变化量小于0.1mm。An impeller for a catheter pump, which can be accommodated and rotated in a pump casing of the catheter pump; the impeller includes a hub and blades arranged on the hub. The tip of the blade has a blade root arranged on the hub. When the impeller is switched from the minimum working speed to the maximum working speed under the working state, the variation of the outer diameter of the blade tip is less than 0.3mm. Furthermore, the variation of the outer diameter of the blade tip is less than 0.1mm.

一种导管泵的泵体，泵体具有血液出口和血液进口的泵壳、容纳在泵壳内可操纵地旋转以从血液进口向血液出口泵送血液的叶轮；泵体具有适于介入受试者的脉管系统或者在受试者脉管系统中输送的径向收折状态、对应叶轮不旋转时的自然展开状态和对应叶轮旋转时的工作状态。在泵体从自然展开状态切换至工作状态的过程中，叶轮被配置为其外径变化量小于0.5mm，优选小于0.3mm，更进一步地，小于0.1mm。A pump body of a catheter pump, the pump body has a pump casing with a blood outlet and a blood inlet, and an impeller that is operably rotated in the pump casing to pump blood from the blood inlet to the blood outlet; the pump body has a pump body suitable for interventional testing The vasculature of the subject or the radially collapsed state for delivery in the vasculature of the subject, the natural unfolded state when the impeller is not rotating, and the working state when the impeller is rotating. In the process of switching the pump body from the naturally expanded state to the working state, the impeller is configured such that the change in its outer diameter is less than 0.5mm, preferably less than 0.3mm, and further, less than 0.1mm.

优选的，叶轮被配置为其外径保持不变或增加量小于0.3mm。Preferably, the impeller is configured such that its outer diameter remains unchanged or increases less than 0.3mm.

优选的，泵壳包括限定血液流动通道的覆膜以及支撑展开覆膜的支架；叶轮被容纳在支架内；在泵体由自然展开状态切换至工作状态的过程中，支架被配置为不参与引起覆膜的弹性变形和塑性变形，或者，泵体处于工作状态下，支架被配置为不参与引起覆膜的弹性变形和塑性变形。Preferably, the pump casing includes a membrane that defines the blood flow channel and a bracket that supports the unfolded membrane; the impeller is accommodated in the bracket; when the pump body is switched from a naturally expanded state to a working state, the bracket is configured not to participate in causing Elastic deformation and plastic deformation of the coating, or, when the pump body is in working condition, the bracket is configured not to participate in causing the elastic deformation and plastic deformation of the coating.

优选的，在泵体由自然展开状态切换至工作状态的过程中，支架的外径的增大率不超过1％。Preferably, the increase rate of the outer diameter of the bracket does not exceed 1% during the process of switching the pump body from the naturally expanded state to the working state.

优选的，在泵体由自然展开状态切换至工作状态的过程中，覆膜的形变不超过其弹性变形极限，或者，泵体处于工作状态下，覆膜的形变不超过其弹性变形极限。Preferably, when the pump body is switched from the naturally expanded state to the working state, the deformation of the coating does not exceed its elastic deformation limit, or when the pump body is in the working state, the deformation of the coating does not exceed its elastic deformation limit.

优选的，叶轮包括固定套设在叶轮轴上的轮毂以及设置于轮毂上的叶片；叶片具有设置于轮毂上的叶根、远离轮毂的叶顶；叶顶和支架的内壁之间限定有泵间隙；泵间隙在径向上的间隙宽度小于1.5mm。Preferably, the impeller includes a hub fixedly sleeved on the impeller shaft and blades arranged on the hub; the blade has a blade root arranged on the hub and a blade tip away from the hub; a pump gap is defined between the blade tip and the inner wall of the bracket ; The gap width of the pump gap in the radial direction is less than 1.5mm.

优选的，在泵体由自然展开状态切换至工作状态的过程中，泵间隙在径向上的间隙宽度变化量小于0.5mm。Preferably, during the process of switching the pump body from the naturally expanded state to the working state, the variation of the gap width of the pump gap in the radial direction is less than 0.5mm.

优选的，导管泵的泵体包括如上任意一项的叶轮。Preferably, the pump body of the catheter pump includes any one of the above impellers.

一种导管泵，包括：马达、穿设在导管中且近端与马达的输出轴传动连接的驱动轴、可通过导管被输送至心脏的期望位置泵送血液的泵体。泵体包括：如上任意一项的叶轮和容纳叶轮的泵壳，或者，如上任意一项的泵体；泵体的泵壳连接至导管的远端，叶轮连接驱动轴的远端。A catheter pump includes: a motor, a drive shaft that passes through the catheter and is connected to the output shaft of the motor at its proximal end, and a pump body that can be delivered to a desired position of the heart through the catheter to pump blood. The pump body includes: the impeller of any one of the above items and the pump housing containing the impeller, or, the pump body of any item above; the pump housing of the pump body is connected to the distal end of the conduit, and the impeller is connected to the distal end of the drive shaft.

采用本实施例的方案，本实施例的叶轮的叶片利用位于反折部内侧的第一部分来平衡位于反折部外侧的第二部分的径向扩展量，通过设有反折部来设置内外不同延伸方向的部分来平衡转动时产生的径向直径变化，减低叶轮因转速的增高而使得叶轮外径过渡变化，能够使得叶轮的水力学性能保持稳定，进而保持叶轮在工作转速范围内工作时可以持续稳定地高效工作。Adopting the solution of this embodiment, the blades of the impeller in this embodiment use the first part located inside the reflexed part to balance the radial expansion of the second part located outside the reflexed part, and the internal and external differences are set by providing the reflexed part. The part in the extension direction is used to balance the radial diameter change during rotation, and reduce the transitional change in the outer diameter of the impeller due to the increase in the speed of the impeller, which can keep the hydraulic performance of the impeller stable, and then keep the impeller working within the operating speed range. Work continuously and efficiently.

本实施例的叶轮在工作转速范围内外径变化量保持不变或位于较小的变化范围，具有较佳的外径稳定保持能力，使血泵在较宽的转速范围内保持工作的稳定性，性能和转速的线性匹配，提高血泵的可用程度。The variation of the inner and outer diameters of the impeller in this embodiment remains unchanged or within a small variation range in the working speed range, and has a better ability to maintain stability in the outer diameter, so that the blood pump can maintain working stability in a wider speed range. The linear matching of performance and rotational speed improves the availability of the blood pump.

附图说明Description of drawings

图1是本公开一个实施例提供的导管泵立体示意图；FIG. 1 is a perspective view of a catheter pump provided by an embodiment of the present disclosure;

图2是图1的泵壳示意图；Fig. 2 is a schematic diagram of the pump casing of Fig. 1;

图3是本公开另一个实施例提供的泵壳示意图；Fig. 3 is a schematic diagram of a pump casing provided by another embodiment of the present disclosure;

图4是图3的主视图；Fig. 4 is the front view of Fig. 3;

图5是图4的支架结构示意图；Fig. 5 is a schematic diagram of the bracket structure of Fig. 4;

图6是图5的主视图；Fig. 6 is the front view of Fig. 5;

图7是图6的A-A剖面图；Fig. 7 is the A-A sectional view of Fig. 6;

图8是本公开另一个实施例提供的支架立体图；Fig. 8 is a perspective view of a bracket provided by another embodiment of the present disclosure;

图9是图8的剖面图；Fig. 9 is a sectional view of Fig. 8;

图10是图1的部分示意图；Fig. 10 is a partial schematic diagram of Fig. 1;

图11是图10的支架与叶轮装配示意图；Fig. 11 is a schematic diagram of the assembly of the bracket and the impeller of Fig. 10;

图12是图10的叶轮装配示意图；Figure 12 is a schematic diagram of the assembly of the impeller of Figure 10;

图13是图12的叶轮立体示意图；Fig. 13 is a perspective view of the impeller shown in Fig. 12;

图14是图13的侧视图；Figure 14 is a side view of Figure 13;

图15是图10的泵体剖视图；Fig. 15 is a sectional view of the pump body of Fig. 10;

图16是图15的A-A剖面图。Fig. 16 is an A-A sectional view of Fig. 15 .

附图标记说明：Explanation of reference signs:

1、动力组件；2、耦合器；3、导管；4、泵体；5、无创支撑件；6、远端轴承室； 106、血液进口；320、近端轴承室；310、驱动轴；355、叶轮轴；1. Power component; 2. Coupler; 3. Catheter; 4. Pump body; 5. Noninvasive support; 6. Distal bearing chamber; 106. Blood inlet; 320. Proximal bearing chamber; 310. Drive shaft; 355 , impeller shaft;

100、覆膜；101、锥形段；102、覆膜远端；103、圆筒段；105、血液出口；100, coating; 101, tapered section; 102, distal end of coating; 103, cylinder section; 105, blood outlet;

200、支架；201、支架段；202、锥形支架近端；203、锥形支架远端；204、连接支腿；2041、杆体；2042、腿端；205、连接次管；210、连接孔；211、定位扣；300、抗扩展元件；200, bracket; 201, bracket section; 202, proximal end of tapered bracket; 203, distal end of tapered bracket; 204, connecting leg; 2041, rod body; 2042, leg end; 205, connecting secondary pipe; 210, connecting hole ; 211, positioning buckle; 300, anti-expansion element;

410、叶轮；411、叶片；412、轮毂；418、迎流面；419、背流面；A、第一部分； B、第二部分；D2、外反折位置点；D3、内反折位置点；450、轨迹圆；4111、叶顶；4112、叶根；4113、外径不变段；4115、过渡线；4116、过渡部位；4121、轮毂近端；4122、轮毂远端。410, impeller; 411, blade; 412, wheel hub; 418, upflow surface; 419, backflow surface; A, first part; B, second part; D2, outer reflex position point; D3, innerreflex position point 450, track circle; 4111, blade top; 4112, blade root; 4113, section with constant outer diameter; 4115, transition line; 4116, transition part; 4121, hub proximal end; 4122, hub distal end.

具体实施方式Detailed ways

为了使本技术领域的人员更好地理解本公开中的技术方案，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本公开一部分实施例，而不是全部的实施例。基于本公开中的实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都应当属于本公开保护的范围。In order to enable those skilled in the art to better understand the technical solutions in the present disclosure, the technical solutions in the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings in the embodiments of the present disclosure. Obviously, the described The embodiments are only some of the embodiments of the present disclosure, not all of them. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without creative efforts shall fall within the protection scope of the present disclosure.

需要说明的是，当元件被称为“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的另一个元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中另一个元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。It should be noted that when an element is referred to as being “disposed on” another element, it may be directly on the other element or there may be another element in between. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or it may be present intervening with the other element. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for purposes of illustration only and are not intended to represent the only embodiments.

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

本发明所用术语“近”、“远”和“前”、“后”是相对于操纵介入式导管泵的临床医生而言的。术语“近”、“后”是指相对靠近临床医生的部分，术语“远”、“前”则是指相对远离临床医生的部分。例如，体外部分在近端及后端，介入的体内部分在远端及前端。The terms "proximity", "distal" and "anterior" and "posterior" used in the present invention are relative to the clinician who manipulates the interventional catheter pump. The terms "proximal" and "posterior" refer to the part relatively close to the clinician, and the terms "distal" and "anterior" refer to the part relatively far away from the clinician. For example, the extracorporeal part is proximal and posterior, and the intervening intracorporeal part is distal and anterior.

本发明实施例的导管泵用于针对心脏功能衰竭进行辅助，可向心脏泵送血液，实现心脏的部分泵血功能。在适用于左心室辅助的场景中，导管泵将血液从左心室泵入主动脉，为血液循环提供支持，减少受试者心脏的工作负荷，或者在心脏泵血能力不足时提供额外持续的泵血动力支持。The catheter pump in the embodiment of the present invention is used to assist heart failure, and can pump blood to the heart to realize part of the heart's blood pumping function. In scenarios where left ventricular assist is appropriate, catheter pumps pump blood from the left ventricle into the aorta to support circulation, reduce the workload on the subject's heart, or provide additional continuous pumping if the heart's pumping capacity is insufficient Hemodynamic support.

当然，导管泵也可以依托介入式手术将其按照期望介入到受试者的其他目标位置，例如右心室、血管、或者其他器官内部。Of course, the catheter pump can also be inserted into other target locations of the subject as desired, such as the right ventricle, blood vessels, or inside other organs, by means of interventional surgery.

请参阅图1、图2，本公开实施例的导管泵包括动力组件1和工作组件。动力组件1包括壳体以及收纳在壳体内并具有输出轴的马达，工作组件包括导管3、穿设在导管3 中的驱动轴310、泵体4。Please refer to FIG. 1 and FIG. 2 , the catheter pump of the embodiment of the present disclosure includes a power assembly 1 and a working assembly. The power assembly 1 includes a housing and a motor housed in the housing and has an output shaft. The working assembly includes aconduit 3 , adrive shaft 310 passing through theconduit 3 , and apump body 4 .

泵体4可通过导管3被输送至心脏的期望位置例如左心室内泵送血液，包括具有血液进口106和血液出口105的泵壳、收纳在泵壳内的叶轮410。马达设于导管3的近端，通过耦合器2连接导管3，并通过驱动轴310驱动叶轮410旋转泵血。泵体4的泵壳连接至导管3的远端，叶轮410连接驱动轴310的远端。Thepump body 4 can be delivered to a desired position of the heart such as the left ventricle to pump blood through thecatheter 3 , and includes a pump housing with ablood inlet 106 and ablood outlet 105 , and animpeller 410 accommodated in the pump housing. The motor is located at the proximal end of thecatheter 3 , connected to thecatheter 3 through the coupler 2 , and drives theimpeller 410 to rotate and pump blood through thedrive shaft 310 . The pump casing of thepump body 4 is connected to the distal end of theconduit 3 , and theimpeller 410 is connected to the distal end of thedrive shaft 310 .

泵壳包括限定血液流动通道的覆膜100，进一步包括用于支撑展开覆膜100的支架200，支架200的近端和导管3远端连接。支架200的近端设有连接次管205，通过在连接次管205上设有构成母扣的连接孔210，与导管3形成卡扣方式的机械连接构造。The pump casing includes amembrane 100 defining a blood flow channel, and further includes astent 200 for supporting the deployedmembrane 100 , the proximal end of thestent 200 is connected to the distal end of thecatheter 3 . The proximal end of thestent 200 is provided with a connectingsecondary tube 205 , and the connectingsecondary tube 205 is provided with a connectinghole 210 constituting a female buckle to form a snap-fit mechanical connection structure with thecatheter 3 .

叶片411由柔弹性材料制成，在被收折时蓄能，在外界的约束撤除后，叶片411的蓄能释放，使叶片411展开。叶片411为多个，多个叶片411在周向上均匀排布。Theblade 411 is made of soft elastic material, and stores energy when being folded, and releases the energy stored in theblade 411 to unfold theblade 411 after the external restraint is removed. There aremultiple blades 411, and themultiple blades 411 are uniformly arranged in the circumferential direction.

如图12-图14所示，叶片411在轮毂412上更靠近远端4122设置。叶片411具有外径不变段4113。叶片411在轴向的两端分别具有导边(先入水边)和随边(后入水边)。该外径不变段4113位于导边和随边之间，在导边和随边之间曲线延伸。外径不变段4113 的外径为叶片411的最大外径。外径不变段4113和导边、随边之间分别具有过渡部位 4116，通常过渡部位4116可以为倒圆结构。外径不变段4113在叶片411延伸长度的0.5 倍以上，甚至0.8倍以上。外边不变段的两端具有过渡线4115。叶顶4111具有在轴向上曲线延伸的叶顶边缘。叶顶4111边缘在导边(先入水边)和随边(后入水边)之间延伸。叶片411旋转时叶顶4111(叶梢)形成圆形轨迹(轨迹圆450)，叶轮410的外径、叶顶4111外径或叶顶4111所在直径为该圆形轨迹的直径。As shown in FIGS. 12-14 , theblades 411 are disposed on thehub 412 closer to thedistal end 4122 . Theblade 411 has a constantouter diameter section 4113 . The two ends of theblade 411 in the axial direction respectively have a leading edge (the edge entering the water first) and a trailing edge (the edge entering the water last). The constantouter diameter segment 4113 is located between the leading edge and the trailing edge, and extends in a curve between the leading edge and the trailing edge. The outer diameter of the constantouter diameter section 4113 is the maximum outer diameter of theblade 411 . There is atransition part 4116 between thesection 4113 with constant outer diameter and the leading edge and the following edge, and usually thetransition part 4116 can be a rounded structure. The constantouter diameter section 4113 is more than 0.5 times, even more than 0.8 times, the extension length of theblade 411 . Both ends of the outer constant segment havetransition lines 4115. Theblade tip 4111 has a blade tip edge extending curvedly in the axial direction. The edge of theblade tip 4111 extends between the leading edge (the first water edge) and the trailing edge (the last water edge). When theblade 411 rotates, the blade tip 4111 (blade tip) forms a circular track (track circle 450), and the outer diameter of theimpeller 410, the outer diameter of theblade tip 4111 or the diameter of theblade tip 4111 is the diameter of the circular track.

如图10-图16所示，叶轮410能够容纳在导管泵的泵壳内旋转。叶轮410包括轮毂412以及设置于轮毂412上的叶片411。其中，叶片411具有设置于轮毂412上的叶根 4112、远离轮毂412的叶顶4111以及位于叶根4112和叶顶4111(叶梢)之间的反折部 D2D3。叶片411的叶根4112在径向上沿第一周向朝向反折部D2D3倾斜延伸。反折部 D2D3在径向上沿与第一周向相反的第二周向朝向叶片411的叶顶4111倾斜延伸。第一周向与叶轮410的旋转方向相反。第二周向与叶轮410的旋转方向相同(平行)。As shown in Figures 10-16, theimpeller 410 can be accommodated and rotated within the pump casing of the catheter pump. Theimpeller 410 includes ahub 412 andblades 411 disposed on thehub 412 . Wherein, theblade 411 has ablade root 4112 arranged on thehub 412, ablade tip 4111 away from thehub 412, and a reflex portion D2D3 between theblade root 4112 and the blade tip 4111 (blade tip). Theblade root 4112 of theblade 411 obliquely extends radially along the first circumferential direction toward the reflex portion D2D3. The inflection portion D2D3 extends obliquely toward thetip 4111 of theblade 411 in the radial direction along a second circumferential direction opposite to the first circumferential direction. The first circumferential direction is opposite to the direction of rotation of theimpeller 410 . The second circumferential direction is the same (parallel) to the rotation direction of theimpeller 410 .

如图16所示，叶片411具有相背对的内凹迎流面418以及外凸背流面419，叶片411的迎流面418为凹面，背流面419为凸面。叶片411至少存在一横截面(与轴向垂直的截面)，该横截面为C型结构。在该横截面上，叶片411的叶根4112在径向上沿第一周向朝向反折部D2D3倾斜延伸。反折部D2D3在径向上沿与第一周向相反的第二周向朝向叶片411的叶顶4111倾斜延伸。As shown in FIG. 16 , thevane 411 has aconcave inflow surface 418 and aconvex backflow surface 419 opposite to each other. Theinflow surface 418 of theblade 411 is concave, and thebackflow surface 419 is convex. Theblade 411 has at least one cross section (a cross section perpendicular to the axial direction), and the cross section is a C-shaped structure. In this cross section, theblade root 4112 of theblade 411 extends obliquely in the radial direction along the first circumferential direction toward the reflex portion D2D3. The inflection portion D2D3 extends obliquely toward thetip 4111 of theblade 411 in the radial direction along a second circumferential direction opposite to the first circumferential direction.

在叶片411具有最大外径的横截面上。该横截面取自外径不变段4113。较佳的，外径不变段4113任一横截面均具有反折部D2D3，反折部D2D3在内外表面(内外轮廓) 上形成相应的反折位置点D2、D3。反折部D2D3在背流面419形成一由外反折位置点 D2构成的连续的外反折线，在迎流面418形成一由内反折位置点D3构成的连续的内反折线。叶片411的叶根4112在径向上沿第一周向朝向反折部D2D3倾斜延伸。反折部 D2D3在径向上沿与第一周向相反的第二周向朝向叶片411的叶顶4111倾斜延伸。On the cross-section where theblade 411 has the largest outer diameter. The cross-section is taken fromsection 4113 of constant outer diameter. Preferably, any cross-section of the constantouter diameter section 4113 has a reflexion portion D2D3, and the reflexion portion D2D3 forms corresponding reflexion position points D2 and D3 on the inner and outer surfaces (inner and outer contours). The inflection portion D2D3 forms a continuous outer inflection line formed by the outer inflection position point D2 on thebackflow surface 419, and a continuous inward inflection line formed by the inward inflection position point D3 on theupstream surface 418. Theblade root 4112 of theblade 411 obliquely extends radially along the first circumferential direction toward the reflex portion D2D3. The inflection portion D2D3 extends obliquely toward thetip 4111 of theblade 411 in the radial direction along a second circumferential direction opposite to the first circumferential direction.

叶片411包括位于叶根4112与反折部D2D3之间的第一部分A、位于反折部D2D3 和叶顶4111之间的第二部分B。第一部分A和第二部分B整体在径向上延伸，且周向延伸方向相反。Theblade 411 includes a first portion A located between theblade root 4112 and the reflex portion D2D3 , and a second portion B located between the reflex portion D2D3 and theblade tip 4111 . The first part A and the second part B extend radially as a whole, and the direction of circumferential extension is opposite.

经发明人研究发现，叶轮410在转动时，其第一部分A和第二部分B分别受到旋转的离心力、以及流体给予叶片411的反作用力、流体背压等多个作用力，在多个作用力(共同作用力)的共同作用下由于第一部分A和第二部分B在周向上的延伸方向相反，分别在第一部分A和第二部分B所产生的效果也不同。其中，位于第一部分A径向外侧第二部分B在共同作用力下会沿径向向外进行一定程度的扩展，使得叶轮410具有直径增大的趋势。而位于第二部分B径向内侧第一部分A，在共用作用力下会沿径向向内进行一定程度的收缩，使得叶片411具有直径缩小的趋势。The inventors have found that when theimpeller 410 is rotating, its first part A and second part B are respectively subjected to multiple forces such as the centrifugal force of rotation, the reaction force given to theblade 411 by the fluid, and the fluid back pressure. Under the combined action of (combined force), since the first part A and the second part B extend in opposite directions in the circumferential direction, the effects produced by the first part A and the second part B are also different. Wherein, the second part B located radially outside the first part A will expand radially outward to a certain extent under the joint force, so that the diameter of theimpeller 410 tends to increase. The first part A located radially inside the second part B will contract radially inward to a certain extent under the common force, so that the diameter of theblade 411 tends to shrink.

其中，流体给予叶片411的反作用力(阻力)为主要作用力，第一部分A所延伸的第一周向与反作用力方向大致平行，该反作用力作用于第一部分A时将第一部分A向轮毂412下压，促进第一部分A朝向轮毂412移动，形成收缩趋势。第二部分B所延伸的第二周向与反作用力方向大致相反，该反作用力作用于第二部分B时将第二部分B 向后推动使其向外扩展，促使第二部分B径向展开，形成扩展趋势。Wherein, the reaction force (resistance) given by the fluid to theblade 411 is the main force, and the first circumferential direction in which the first part A extends is roughly parallel to the direction of the reaction force. Pressing down promotes the movement of the first part A towards thehub 412 to form a shrinking tendency. The second circumferential direction in which the second part B extends is roughly opposite to the direction of the reaction force. When the reaction force acts on the second part B, the second part B is pushed backwards to expand outward, and the second part B is radially expanded. , forming an expansion trend.

因此，本实施例的叶轮410的叶片411利用位于反折部D2D3内侧的第一部分A来平衡位于反折部D2D3外侧的第二部分B的径向扩展量，通过设有反折部D2D3来设置内外不同延伸方向的部分来平衡转动时产生的径向直径变化，减低叶轮410因转速的增高而使得叶轮410外径过渡变化，能够使得叶轮410的水力学性能保持稳定，进而保持叶轮410在工作转速范围内工作时可以持续稳定地高效工作。Therefore, theblade 411 of theimpeller 410 in this embodiment utilizes the first part A located inside the reflexed part D2D3 to balance the radial expansion of the second part B located outside the reflexed part D2D3, and is provided by providing the reflexed part D2D3. Parts with different extension directions inside and outside are used to balance the radial diameter change generated during rotation, and reduce the transitional change in the outer diameter of theimpeller 410 due to the increase in the speed of theimpeller 410, which can keep the hydraulic performance of theimpeller 410 stable, and then keep theimpeller 410 in operation. It can work continuously and stably with high efficiency when working within the speed range.

叶轮410在工作转速范围内外径变化量保持不变或位于较小的变化范围，具有较佳的外径稳定保持能力，使血泵在较宽的转速范围内保持工作的稳定性，性能和转速的线性匹配，提高血泵的可用程度。The variation of the inner and outer diameters of theimpeller 410 in the working speed range remains unchanged or within a small changing range, and has a better ability to maintain stability in the outer diameter, so that the blood pump can maintain working stability, performance and speed in a wide speed range The linear matching improves the availability of the blood pump.

本实施例中，在转动过程中叶轮410外径变化量较小，进而该导管泵在工作过程中可以稳定地保持泵间隙。具体的，叶顶4111和支架200的内壁之间限定有泵间隙。泵间隙在径向上的间隙宽度小于1.5mm。In this embodiment, the change of the outer diameter of theimpeller 410 is small during the rotation process, so that the catheter pump can stably maintain the pump clearance during the working process. Specifically, a pump gap is defined between thevane top 4111 and the inner wall of thebracket 200 . The gap width of the pump gap in the radial direction is less than 1.5mm.

叶轮410具有不旋转时的自然展开状态和对应最大工作转速旋转时的工作状态。其中，叶轮410从自然展开状态切换至工作状态，叶顶4111的直径变化量小于0.5mm，也即，叶轮410的外径变化量位于±0.5mm范围内(外径增大量在0.5mm以内，外径减小量在0.5mm以内)。优选地，叶轮410的外径变化量小于0.3mm(±0.3mm范围)，更进一步地，叶轮410的外径变化量小于0.1mm(±0.1mm范围)。Theimpeller 410 has a natural unfolding state when not rotating and a working state when rotating corresponding to the maximum working speed. Wherein, theimpeller 410 is switched from the naturally unfolded state to the working state, and the diameter variation of theblade tip 4111 is less than 0.5mm, that is, the outer diameter variation of theimpeller 410 is within the range of ±0.5mm (the outer diameter increase is within 0.5mm, The outer diameter reduction is within 0.5mm). Preferably, the variation of the outer diameter of theimpeller 410 is less than 0.3 mm (in the range of ±0.3 mm), further, the variation of the outer diameter of theimpeller 410 is less than 0.1 mm (in the range of ±0.1 mm).

值得注意的是，上述数值包括从下限值到上限值之间以一个单位递增的下值和上值的所有值，在任何下值和任何更高值之间存在至少两个单位的间隔即可。It should be noted that the above values include all values from the lower value to the upper value in increments of one unit for the lower and upper values, with a separation of at least two units between any lower value and any higher value That's it.

举例来说，阐述的叶轮410的外径变化量位于±0.5mm，优选为±0.3mm范围，更优选为±0.1mm范围，目的是为说明上述未明确列举的诸如+0.08、-0.05、±0.03等值。For example, the stated variation of the outer diameter of theimpeller 410 is in the range of ±0.5 mm, preferably ±0.3 mm, and more preferably ±0.1 mm, for the purpose of illustrating the above-mentioned unspecified values such as +0.08, -0.05, ±0.05 mm 0.03 equivalent.

如上述，以0.1为间隔单位的示例范围，并不能排除以适当的单位例如0.01、0.02、0.03、0.04、0.05等数值单位为间隔的增长。这些仅仅是想要明确表达的示例，可以认为在最低值和最高值之间列举的数值的所有可能组合都是以类似方式在该说明书明确地阐述了的。As mentioned above, the example ranges in intervals of 0.1 do not preclude increments in intervals of appropriate units such as 0.01, 0.02, 0.03, 0.04, 0.05 etc. These are merely examples intended to be expressly stated, and it is considered that all possible combinations of numerical values recited between the lowest value and the highest value are expressly set forth in this specification in a similar manner.

除非另有说明，所有范围都包括端点以及端点之间的所有数字。与范围一起使用的“大约”或“近似”适合于该范围的两个端点。因而，“大约20到30”旨在覆盖“大约 20到大约30”，至少包括指明的端点。Unless otherwise indicated, all ranges include the endpoints and all numbers between the endpoints. "About" or "approximately" used with a range applies to both endpoints of the range. Thus, "about 20 to 30" is intended to cover "about 20 to about 30", inclusive of at least the indicated endpoints.

本文中出现的其他关于数值范围的限定说明，可参照上述描述，不再赘述。For other limitations on the range of values presented herein, reference may be made to the above description, and details are not repeated here.

如图16所示，第一部分A在径向上的(投影)长度La大于0.5倍的第二部分B在径向上的(投影)长度Lb。也即，第一部分A的径向长度La大于0.5倍的第二部分B 的径向长度，La＞0.5Lb。优选的，第一部分A在径向上的(投影)长度La大于第二部分B在径向上的(投影)长度Lb。As shown in FIG. 16 , the (projected) length La of the first portion A in the radial direction is greater than 0.5 times the (projected) length Lb of the second portion B in the radial direction. That is, the radial length La of the first portion A is greater than 0.5 times the radial length of the second portion B, La>0.5Lb. Preferably, the (projected) length La of the first portion A in the radial direction is greater than the (projected) length Lb of the second portion B in the radial direction.

在有的实施例中，第一部分A的叶片411厚度大于第二部分B的叶片411厚度。第一部分A相较于第二部分B具有更稳定的自身结构，借此提升叶片411结构强度以保证流体泵送效率。而在本实施例中，第二部分B的最大厚度大于0.7倍的第一部分A 的最大厚度。其中，厚度方向为内凹迎流面418或外凸背流面419在横截面上的轮廓线的法线方向。进一步地，第二部分B的最大厚度大于第一部分A的最大厚度。如此，通过提升第二部分B的厚度，进而提升第二部分B抗形变能力，避免向外扩张程度，借此稳定保持叶轮410外径。In some embodiments, the thickness of thevanes 411 of the first part A is greater than the thickness of thevanes 411 of the second part B. Compared with the second part B, the first part A has a more stable structure, thereby improving the structural strength of theblade 411 to ensure the fluid pumping efficiency. In this embodiment, however, the maximum thickness of the second portion B is greater than 0.7 times the maximum thickness of the first portion A. Wherein, the thickness direction is the normal direction of the contour line of theconcave upflow surface 418 or theconvex backflow surface 419 on the cross section. Further, the maximum thickness of the second part B is greater than the maximum thickness of the first part A. In this way, by increasing the thickness of the second part B, the anti-deformation capability of the second part B is further improved to avoid outward expansion, thereby stably maintaining the outer diameter of theimpeller 410 .

为平衡第一部分A和第二部分B的径向变化，稳定保持叶轮410外径，第一部分A 的横截面积在第二部分B的横截面积的0.5倍以上。优选的，第一部分A的横截面积在第二部分B的横截面积的0.8倍以上。第一部分A的横截面积在第二部分B的横截面积的1.2倍以下。通过增多第一部分A及减少第二部分B，平衡第一部分A和第二部分 B所占比例，借此平衡第一部分A和第二部分B的径向变化。In order to balance the radial variation of the first part A and the second part B and maintain the outer diameter of theimpeller 410 stably, the cross-sectional area of the first part A is more than 0.5 times the cross-sectional area of the second part B. Preferably, the cross-sectional area of the first part A is more than 0.8 times the cross-sectional area of the second part B. The cross-sectional area of the first part A is 1.2 times or less than the cross-sectional area of the second part B. By increasing the first part A and reducing the second part B, the proportions of the first part A and the second part B are balanced, thereby balancing the radial changes of the first part A and the second part B.

进一步地，如图16所示，在叶片411的一横截面上，反折部D2D3的切线穿过轮毂412的圆心O。第一部分A在垂直于切线OO₂方向上的长度H1为在第二部分B垂直于切线OO₂方向上的长度H2的0.3倍以上，优选的，H1为H2的0.5倍以上。Further, as shown in FIG. 16 , on a cross section of theblade 411 , the tangent of the reflexed portion D2D3 passes through the center O of thehub 412 . The length H1 of the first part A in the direction perpendicular to the tangent_OO2 is at least 0.3 times the length H2 of the second part B in the direction perpendicular to the tangent_OO2 . Preferably, H1 is at least 0.5 times the length of H2.

在叶轮410的一横截面上，外凸背流面419具有一位置点D2。该位置点的切线OO₂经过轮毂412的圆心O，其中，叶片411的横截面位于该切线OO₂的周向一侧，或者，定义一经过该位置点与轮毂412的圆心的直线，其中，叶片411的横截面(的全部)位于该直线的周向一侧。位置点D2位于叶根4112和叶顶4111之间，该位置点即为反折部D2D3在该横截面的轮廓上所形成的外反折位置点D2。On a cross-section of theimpeller 410, the convexback flow surface 419 has a point D2. The tangent line_OO2 of the position point passes through the center O of thehub 412, wherein the cross section of theblade 411 is located on one side of the circumferential direction of the tangent line_OO2 , or defines a straight line passing through the position point and the center of circle of thehub 412, wherein, The cross-section of the blade 411 (all of it) is located on the circumferential side of the straight line. The position point D2 is located between theblade root 4112 and theblade tip 4111, and this position point is the outer inflection point D2 formed by the inflection portion D2D3 on the outline of the cross section.

如图16所示，位于第一部分A的内凹迎流面418或外凸迎流面418上的任意点，定义该任意点的切线具有一远离第二部分B方向的切线向量

该任意点的切线与轮毂412的外轮廓线存在一接触点，定义轮毂412的圆心具有朝向接触点的射线向量

切线向量

和射线向量

之间的夹角β大于90度且小于180度位于第一部分A的内凹迎流面418或外凸迎流面418上的位置点越靠近反折部D2D3其β角越大。As shown in FIG. 16 , at any point on theconcave inflow surface 418 or theconvex outflow surface 418 of the first part A, the tangent defining the point has a tangent vector away from the direction of the second part B

There is a point of contact between the tangent of this arbitrary point and the outer contour of thehub 412, defining the center of circle of thehub 412 to have a ray vector towards the contact point

tangent vector

and ray vector

The angle β between them is greater than 90 degrees and less than 180 degrees, and the closer the point on theconcave inflow surface 418 or the outwardconvex inflow surface 418 of the first part A is closer to the reflexion portion D2D3, the greater the β angle.

叶根4112在内凹迎流面418和轮毂412之间设有圆弧过渡部，和/或，叶根4112 在外凹迎流面418和轮毂412之间设有圆弧过渡部。其中，圆弧过渡部的曲率半径小于第一部分A的曲率半径。Theblade root 4112 is provided with a circular arc transition portion between theconcave inflow surface 418 and thehub 412 , and/or, theblade root 4112 is provided with a circular arc transition portion between theconcave inflow surface 418 and thehub 412 . Wherein, the radius of curvature of the arc transition portion is smaller than the radius of curvature of the first portion A.

承接上文描述，叶轮410在泵壳内可操纵地旋转以从血液进口106向血液出口105泵送血液的叶轮410。泵体4具有适于介入受试者的脉管系统或者在受试者脉管系统中输送的径向收折状态、对应叶轮410不旋转时的自然展开状态和对应叶轮410旋转时的工作状态。Continuing from the above description, theimpeller 410 is operably rotated within the pump housing to pump theimpeller 410 of blood from theblood inlet 106 to theblood outlet 105 . Thepump body 4 has a radially collapsed state suitable for intervening in the subject's vasculature or transporting in the subject's vasculature, a naturally unfolded state corresponding to when theimpeller 410 does not rotate, and a working state corresponding to when theimpeller 410 rotates .

其中，在泵体4从自然展开状态切换至工作状态的过程中，叶轮410被配置为其外径变化量小于0.5mm。也即，叶轮410的外径变化在±0.5mm范围内。优选地，叶轮 410被配置为其外径变化量小于0.3mm，更进一步地，叶轮410被配置为其外径变化量小于0.1mm。叶轮410被配置为其外径保持不变或增加量小于0.3mm。Wherein, in the process of switching thepump body 4 from the naturally expanded state to the working state, theimpeller 410 is configured such that its outer diameter changes less than 0.5 mm. That is, the outer diameter of theimpeller 410 varies within ±0.5mm. Preferably, theimpeller 410 is configured so that the variation of its outer diameter is less than 0.3mm, further, theimpeller 410 is configured so that the variation of its outer diameter is less than 0.1mm. Theimpeller 410 is configured such that its outer diameter remains unchanged or increases by less than 0.3mm.

进一步地，叶轮410的工作状态可以取最大工作转速时的(最大转速)工作状态。如此，在泵体4从自然展开状态(叶轮410静止)切换至最大转速工作状态的过程中，叶轮410被配置为其外径(外径)变化量小于0.5mm。Further, the working state of theimpeller 410 may be the working state at the maximum working speed (maximum speed). In this way, during the process of switching thepump body 4 from the natural unfolding state (theimpeller 410 is at rest) to the maximum rotating speed working state, theimpeller 410 is configured such that the variation of its outer diameter (outer diameter) is less than 0.5 mm.

在本实施例中，泵壳在叶轮410工作旋转过程中，内径变化较小，在泵体4由自然展开状态切换至工作状态的过程中，支架200的外径的增大率不超过1％。具体的，在泵体4由自然展开状态切换至工作状态的过程中，覆膜100的形变不超过其弹性变形极限，或者，泵体4处于工作状态下，覆膜100的形变不超过其弹性变形极限。In this embodiment, the inner diameter of the pump casing changes little during the working rotation of theimpeller 410, and the increase rate of the outer diameter of thebracket 200 does not exceed 1% when thepump body 4 is switched from the naturally expanded state to the working state. . Specifically, when thepump body 4 is switched from the naturally expanded state to the working state, the deformation of thecoating 100 does not exceed its elastic deformation limit, or, when thepump body 4 is in the working state, the deformation of thecoating 100 does not exceed its elastic deformation limit. deformation limit.

承接上文描述，泵壳包括限定血液流动通道的覆膜100以及用于支撑展开覆膜100的支架200。叶顶4111隙位于叶轮410的叶顶4111边缘和可折叠支架200的内壁之间。在其他实施例中，覆膜100集成有支架200，例如覆膜100内集成有螺旋状支撑体，此时叶顶隙(泵间隙)位于覆膜100内壁和叶顶4111之间。Following the above description, the pump housing includes amembrane 100 defining a blood flow channel and abracket 200 for supporting themembrane 100 when deployed. Thetip 4111 gap is located between the edge of thetip 4111 of theimpeller 410 and the inner wall of thefoldable support 200 . In other embodiments, themembrane 100 is integrated with abracket 200 , for example, a helical support is integrated in themembrane 100 . At this time, the blade top space (pump gap) is located between the inner wall of themembrane 100 and theblade tip 4111 .

其中，在泵体4由自然展开状态切换至工作状态的过程中，泵间隙在径向上的间隙宽度H3变化量小于0.5mm，进一步地小于0.3mm。具体的，叶轮410从静止旋转到最大工作转速的过程中其外径的增大量不超过0.3mm。叶轮410在工作转速范围(例如 10000-30000rpm)内时其外径的变化量在0.3mm以内。叶轮410在最低工作转速 (10000rpm)旋转至最高工作转速(30000rpm)时，叶轮410的外径的变化量在0.3mm 以内，进一步地，叶轮410的外径变化量在0.1mm以内，以稳定泵间隙。Wherein, during the process of switching thepump body 4 from the naturally unfolded state to the working state, the variation of the gap width H3 of the pump gap in the radial direction is less than 0.5 mm, and further less than 0.3 mm. Specifically, the increase of the outer diameter of theimpeller 410 during the process of rotating from stationary to the maximum operating speed does not exceed 0.3 mm. The variation of the outer diameter of theimpeller 410 is within 0.3mm when theimpeller 410 is in the working speed range (for example, 10000-30000rpm). When theimpeller 410 rotates from the lowest operating speed (10000rpm) to the highest operating speed (30000rpm), the variation of the outer diameter of theimpeller 410 is within 0.3mm, and further, the variation of the outer diameter of theimpeller 410 is within 0.1mm, so as to stabilize the pump gap.

在本实施例中，支架200可以设于覆膜100内，或者设在覆膜100外。叶轮收容在支架200内并位于覆膜100内，支架200支撑在覆膜100的远端102，部分支架200位于覆膜100的远端102外侧，另一部分支架200位于覆膜100内。In this embodiment, thestent 200 can be arranged inside themembrane 100 or outside themembrane 100 . The impeller is accommodated in thesupport 200 and located in themembrane 100 , thebracket 200 is supported on thedistal end 102 of themembrane 100 , part of thebracket 200 is located outside thedistal end 102 of themembrane 100 , and the other part of thebracket 200 is located in themembrane 100 .

支架200向覆膜100施加展开作用力的情况下，覆膜100不会产生弹性形变和塑性形变，覆膜100具备较佳的抗变形能力。进而，在泵血过程中更好地维持形状，与稳定保持形状的叶轮相配合，借此保持泵间隙的恒定，维持泵效处于最佳工作效能。When thestent 200 applies a spreading force to thecovering film 100 , the coveringfilm 100 will not undergo elastic deformation and plastic deformation, and thecovering film 100 has better deformation resistance. Furthermore, it better maintains the shape during the blood pumping process, cooperates with the impeller that maintains the shape stably, thereby keeping the pump clearance constant and maintaining the pump efficiency at the best working performance.

覆膜100具有作为主体结构的圆筒段103和位于圆筒段103近端的锥形段101，锥形段101的近端套设于导管3外，与导管3外壁固定。导管3通过位于其远端的近端轴承室连接支架200近端，近端轴承室内设有对驱动轴310进行转动支撑的近端轴承。在一个实施例中，连接次管205直接构成近端轴承室并通过定位扣211定位固定近端轴承。Themembrane 100 has acylindrical section 103 as the main structure and aconical section 101 located at the proximal end of thecylindrical section 103 . The proximal end of theconical section 101 is sheathed outside thecatheter 3 and fixed to the outer wall of thecatheter 3 . Thecatheter 3 is connected to the proximal end of thebracket 200 through a proximal bearing chamber at its distal end, and the proximal bearing chamber is provided with a proximal bearing for rotationally supporting thedrive shaft 310 . In one embodiment, the connectingsecondary tube 205 directly constitutes the proximal bearing chamber, and the proximal bearing is positioned and fixed through thepositioning buckle 211 .

支架200远端设有远端轴承室6，远端轴承室6内设有对驱动轴310的远端转动支撑的远端轴承。支架200维持近端轴承室320和远端轴承室6的间距，借此为驱动轴310 提供稳定的转动支撑。驱动轴310包括穿设在导管3内的软轴和连接至软轴远端的硬轴 355(叶轮轴355)，叶轮410的轮毂412套设在硬轴355上，硬轴355的近端和远端分别穿设在近端轴承和远端轴承中。借助硬轴355及两端的轴承，为叶轮在泵壳中提供稳定的强度支撑，保持叶轮在泵壳中位置的稳定。Adistal bearing chamber 6 is provided at the distal end of thebracket 200 , and a distal bearing for supporting the rotation of the drivingshaft 310 is provided in thedistal bearing chamber 6 . Thebracket 200 maintains the distance between theproximal bearing chamber 320 and thedistal bearing chamber 6 , thereby providing stable rotational support for the drivingshaft 310 . Thedrive shaft 310 includes a flexible shaft that passes through thecatheter 3 and a hard shaft 355 (impeller shaft 355) that is connected to the distal end of the soft shaft. Thehub 412 of theimpeller 410 is sleeved on thehard shaft 355. The proximal end of thehard shaft 355 and The distal end is respectively passed through the proximal end bearing and the distal end bearing. With the help of thehard shaft 355 and the bearings at both ends, stable strength support is provided for the impeller in the pump casing, and the position of the impeller in the pump casing is kept stable.

耦合器2连接导管3的近端，导管3和软轴之间具有液体流道，通过液体流道输入的灌注液可以为软轴的转动提供润滑并避免转动摩擦生热。耦合器2上设有与液体流道相连通的灌注液输入部20，灌注液输入部20与液体流道连通。耦合器2的远端设有供导管3穿过的保持套260，保持套260可对导管3起到固定的作用。The coupler 2 is connected to the proximal end of thecatheter 3, and there is a fluid channel between thecatheter 3 and the flexible shaft, and the perfusate input through the fluid channel can provide lubrication for the rotation of the flexible shaft and avoid rotation friction and heat generation. The coupler 2 is provided with aperfusate input part 20 which communicates with the liquid flow channel, and theperfusate input part 20 communicates with the liquid flow channel. The distal end of the coupler 2 is provided with a retainingsleeve 260 through which thecatheter 3 passes, and the retainingsleeve 260 can fix thecatheter 3 .

远端轴承室6的远端连接有无创支撑件5，无创支撑件5为一柔性管体结构，表现为端部呈圆弧状或卷绕状的柔性凸起，从而无创支撑件5以无创或无损伤的方式支撑在心室内壁上，将泵体4的血液进口106与心室内壁隔开，避免泵体4在工作过程中由于血液的反作用力而使得泵体4的吸入口贴合在心室内壁上，保证泵吸的有效面积。The distal end of thedistal bearing chamber 6 is connected with a non-invasive support member 5. The non-invasive support member 5 is a flexible tubular structure, which is shown as a flexible protrusion with an arc-shaped or coiled end. Or support it on the inner wall of the ventricle in a non-damaging manner, and separate theblood inlet 106 of thepump body 4 from the inner wall of the ventricle, so as to prevent the suction port of thepump body 4 from fitting in the ventricle due to the reaction force of the blood during the working process of thepump body 4 On the wall, ensure the effective area of pumping.

泵壳包括适于介入受试者的脉管系统或者在受试者脉管系统中输送的径向收折状态、对应叶轮不旋转时的自然展开状态和对应叶轮旋转时的工作状态。在泵壳由径向收折状态切换至自然展开状态的过程中，或者由自然展开状态切换至工作状态的过程中，覆膜100的形变不超过其塑性变形极限。The pump housing includes a radially collapsed state suitable for intervention in or delivery in a subject's vasculature, a naturally deployed state corresponding to non-rotating impellers, and an operational state corresponding to rotating impellers. During the process of switching the pump casing from the radially retracted state to the natural unfolded state, or from the naturally unfolded state to the working state, the deformation of themembrane 100 does not exceed its plastic deformation limit.

承接上文描述，泵壳包括限定血液流动通道的覆膜100以及支撑展开覆膜100的支架200。叶轮410被容纳在支架200内。在泵体4由自然展开状态切换至工作状态的过程中，支架200被配置为不参与引起覆膜的弹性变形和塑性变形。或者，泵体4处于工作状态下，支架200被配置为不参与引起覆膜100的弹性变形和塑性变形。Following the above description, the pump casing includes amembrane 100 defining a blood flow channel and abracket 200 supporting themembrane 100 for deployment. Theimpeller 410 is accommodated within thebracket 200 . During the process of switching thepump body 4 from the naturally expanded state to the working state, thebracket 200 is configured not to participate in causing the elastic deformation and plastic deformation of the membrane. Alternatively, when thepump body 4 is in a working state, thebracket 200 is configured not to participate in causing elastic deformation and plastic deformation of themembrane 100 .

泵体4具有介入构型以及工作构型。在泵体4对应介入构型下，泵壳和叶轮处于径向收折状态，以便泵体4以第一外径尺寸介入受试者的脉管系统或者在脉管系统中输送。在泵体4对应工作构型下，泵壳和叶轮处于径向展开状态，以便泵体4以大于第一外径尺寸的第二外径尺寸在期望位置泵送血液。Thepump body 4 has an intervention configuration as well as a working configuration. In the corresponding intervention configuration of thepump body 4 , the pump casing and the impeller are in a radially retracted state, so that thepump body 4 is inserted into the vasculature of the subject with the first outer diameter or delivered in the vasculature. In the corresponding working configuration of thepump body 4, the pump casing and the impeller are in a radially expanded state, so that thepump body 4 pumps blood at a desired position with a second outer diameter dimension greater than the first outer diameter dimension.

泵体4包括径向收折状态和径向展开状态，泵壳可操作地在径向收折状态与径向展开状态之间切换。相比于未受力状态，覆膜100在泵壳处于径向展开状态下不发生塑性形变。Thepump body 4 includes a radially folded state and a radially expanded state, and the pump casing is operable to switch between the radially folded state and the radially expanded state. Compared with the unstressed state, thecoating 100 does not undergo plastic deformation when the pump casing is in a radially expanded state.

通过设置可收折的泵壳，使得泵壳具有较小的收折尺寸和较大的展开尺寸，以兼顾在介入/输送过程中减轻受试者痛苦且介入容易，以及提供大流量这两方面的需求。By setting a collapsible pump casing, the pump casing has a smaller retracted size and a larger expanded size, so as to reduce the pain of the subject during the intervention/transportation process, facilitate the intervention, and provide a large flow rate demand.

支架200的多网孔尤其是菱形网孔的设计可实现较佳的实现收折，同时借助镍钛合金的记忆特性实现展开。叶片由柔弹性材料制成，在被收折时蓄能，在外界的约束撤除后，叶片的蓄能释放，使叶片展开。The multi-mesh design of thestent 200 , especially the rhombic mesh design, can achieve better folding and unfolding by virtue of the memory properties of nickel-titanium alloy. The blades are made of soft and elastic materials, which store energy when they are folded, and release the energy storage of the blades to unfold them after the external constraints are removed.

泵壳是借助外界的约束实现收折，在约束撤除后，泵壳实现自展开。上述的外界约束的施加，通过滑动套设在导管3外的折叠鞘管(未示出)完成。当折叠鞘管在导管3 外向前移动时，可将泵壳整体收纳在其内，实现泵壳的强制收折。当折叠鞘管向后移动时，泵壳受到的径向约束消失，泵壳自展开。The pump casing is folded with the help of external constraints. After the constraints are removed, the pump casing realizes self-expansion. The application of the above-mentioned external constraints is accomplished by sliding a folded sheath (not shown) sleeved outside thecatheter 3 . When the folded sheath moves forward outside thecatheter 3, the pump casing can be accommodated in it as a whole to realize the forced folding of the pump casing. When the folded sheath moves backward, the radial constraint on the pump casing disappears, and the pump casing self-expands.

由上述，泵壳的收折是借助折叠鞘管施加的径向约束力实现的，而泵壳包含的叶轮收纳在泵壳内。因此，实质上，泵壳的收折过程是：折叠鞘管对泵壳施加径向约束力，泵壳径向压缩时，对叶轮施加径向约束力。From the above, the folding of the pump casing is realized by the radial constraint force exerted by the folded sheath, and the impeller contained in the pump casing is accommodated in the pump casing. Therefore, in essence, the folding process of the pump casing is: the folded sheath exerts a radial constraint force on the pump casing, and when the pump casing radially compresses, it exerts a radial constraint force on the impeller.

也就是，泵壳是直接在折叠鞘管的作用下被收折，而叶轮却是直接在泵壳的作用下被收折。而如上述，叶轮具有弹性。因此，尽管处于收折状态，但叶轮收折蓄能使其始终具有径向展开的趋势，进而叶轮会与泵壳内壁接触，并对泵壳施加反作用力。That is, the pump casing is directly retracted under the action of the folding sheath, while the impeller is directly retracted under the action of the pump casing. And as mentioned above, the impeller has elasticity. Therefore, even though it is in a folded state, the energy storage of the impeller always has a tendency to expand radially, and then the impeller will contact the inner wall of the pump casing and exert a reaction force on the pump casing.

在折叠鞘管的约束撤除后，泵壳在自身的记忆特性作用下，支撑弹性的覆膜100展开，叶轮在释放的蓄能作用下自展开。在展开状态下，叶轮的外径小于泵壳的内径。After the restraint of the folded sheath is removed, the pump casing will expand the supportingelastic film 100 under the action of its own memory characteristics, and the impeller will self-expand under the action of the released energy storage. In the deployed state, the outer diameter of the impeller is smaller than the inner diameter of the pump casing.

这样，叶轮的径向外端(也就是叶尖)与泵壳的内壁(具体为支架200内壁)之间保持间隔，该间隔为泵间隙。泵间隙的存在，使得叶轮能无阻碍的旋转而不发生碰壁。In this way, a distance is maintained between the radially outer end of the impeller (that is, the blade tip) and the inner wall of the pump casing (specifically, the inner wall of the bracket 200 ), which is the pump gap. The existence of the pump gap enables the impeller to rotate unimpeded without hitting a wall.

此外，出于流体力学方面的考虑，泵间隙尺寸为较小的数值且被维持，是期望的。在本实施例中，叶轮的外径略小于作为支架200的支架内径，使得在满足叶轮旋转不碰壁的情况下，泵间隙尽可能的小。而泵间隙保持的主要实现手段是通过支架200提供的支撑强度以及覆膜100的抗扩展形变性能，该支撑强度及覆膜100的韧性可抵抗血液背压的作用而不发生过量变形，进而保持泵壳的形状稳定，则泵间隙也被稳定的保持。In addition, for hydrodynamic considerations, it is desirable that the pump clearance size be kept at a small value. In this embodiment, the outer diameter of the impeller is slightly smaller than the inner diameter of the bracket serving as thebracket 200 , so that the pump clearance is as small as possible under the condition that the impeller rotates without hitting a wall. The main means to maintain the pump gap is the support strength provided by thebracket 200 and the expansion and deformation resistance of thecoating 100. The support strength and the toughness of thecoating 100 can resist the blood back pressure without excessive deformation, thereby maintaining The shape of the pump casing is stable, and the pump clearance is also stably maintained.

为保证覆膜100的韧性，提供更稳定的泵间隙，稳定泵效，覆膜100发生塑性变形极限的临界点应力大于等于泵体处于最大工况时由于叶轮的旋转而导致的血液背压对覆膜100施加的力。泵体的最大工况对应于叶轮额定功率下的最大转速。此时，泵流量对应最大值，血液背压也处于最大值。In order to ensure the toughness of thecoating 100, provide a more stable pump clearance, and stabilize the pump efficiency, the critical point stress of the plastic deformation limit of thecoating 100 is greater than or equal to the blood back pressure caused by the rotation of the impeller when the pump body is in the maximum working condition. The force exerted by themembrane 100. The maximum working condition of the pump body corresponds to the maximum speed of the impeller under the rated power. At this time, the pump flow corresponds to the maximum value, and the blood back pressure is also at the maximum value.

本实施例中，血液背压的最大值仍然未超出覆膜100发生塑性变形极限的临界点应力，进而在叶轮旋转的工作状态，覆膜100仍然不会超过塑性变形极限，以降低泵间隙的变化，稳定泵效。In this embodiment, the maximum value of the blood back pressure still does not exceed the critical point stress of the plastic deformation limit of thecoating 100, and then in the working state of the impeller rotation, thecoating 100 will still not exceed the plastic deformation limit, so as to reduce the pump clearance. Change, stable pump efficiency.

进一步地，在泵壳由径向收折状态切换至自然展开状态的过程中，覆膜100的形变不超过其弹性变形极限。在泵壳由自然展开状态切换至工作状态的过程中，覆膜100的形变不超过其弹性变形极限。Further, during the process of switching the pump casing from the radially retracted state to the naturally unfolded state, the deformation of themembrane 100 does not exceed its elastic deformation limit. During the process of switching the pump casing from the naturally expanded state to the working state, the deformation of themembrane 100 does not exceed its elastic deformation limit.

覆膜100发生弹性变形极限的临界点应力大于等于泵体4处于最大工况时由于叶轮的旋转而导致的血液背压对覆膜100施加的力。如此，覆膜100在叶轮停止旋转或流体背压消失时，覆膜100依然可以依靠弹性恢复至初始状态，泵效稳定，且具有更长的使用寿命。The critical point stress of the elastic deformation limit of thecoating 100 is greater than or equal to the force exerted on thecoating 100 by the blood back pressure caused by the rotation of the impeller when thepump body 4 is in the maximum working condition. In this way, when the impeller stops rotating or the fluid back pressure disappears, thecoating 100 can still return to the original state by virtue of its elasticity, the pump efficiency is stable, and it has a longer service life.

需要明确的是，本发明中的覆膜100的形变，是指覆膜100发生圆周方向的长度变形，该形变可以包括褶皱的展平，还可以包括弹性变形甚至塑性变形。在受到径向作用力时，覆膜100的形变体现为周向长度(圆周长)变大。It should be clarified that the deformation of thecoating 100 in the present invention refers to the length deformation of thecoating 100 in the circumferential direction, and the deformation may include flattening of wrinkles, and may also include elastic deformation or even plastic deformation. When subjected to a radial force, the deformation of thecoating 100 is represented by an increase in the circumferential length (circumference length).

在泵壳由自然展开状态切换至工作状态的过程中，覆膜100的直径增大不超过1mm，直径增大率不超过5％，进一步地，不超过3％。借此，覆膜100在流体背压作用下的扩张变形不超过其塑性变形极限，并与叶轮410相配合稳定保持泵间隙。During the process of switching the pump casing from the naturally expanded state to the working state, the diameter of thecoating 100 does not increase by more than 1mm, and the diameter increase rate does not exceed 5%, further, it does not exceed 3%. In this way, the expansion and deformation of themembrane 100 under the fluid back pressure does not exceed its plastic deformation limit, and cooperates with theimpeller 410 to stably maintain the pump clearance.

在泵壳由自然展开状态切换至工作状态的过程中，支架被配置为不参与引起覆膜100的变形。或者，泵壳处于工作状态下，支架被配置为不参与引起覆膜100的变形。该变形包括弹性变形和塑性变形。也就是，在泵壳由自然展开状态切换至工作状态的过程中，支架既不参与引起覆膜100的塑性形变，也不参与引起覆膜100的弹性形变。During the process of switching the pump casing from the naturally expanded state to the working state, the bracket is configured not to participate in causing deformation of themembrane 100 . Alternatively, when the pump casing is in a working state, the bracket is configured not to participate in causing deformation of themembrane 100 . This deformation includes elastic deformation and plastic deformation. That is, when the pump casing is switched from the naturally expanded state to the working state, the bracket neither participates in causing the plastic deformation of thecoating 100 nor participates in causing the elastic deformation of thecoating 100 .

在自然展开状态下，覆膜100的内径等于或略大于支架的外径。例如，覆膜100的直径为支架的外径的1倍至1.1倍。如此，从收折状态到展开状态的整个过程，因为支架的径向扩张所展开的覆膜100并未达到或超出其自身的原有形状(原有直径)。因此，支架并不引起覆膜100的周向拉伸。可以理解的，覆膜100在自然展开状态下并不存在弹性变形或塑性变形，进而支架被配置为不参与引起覆膜100的形变。In a naturally expanded state, the inner diameter of themembrane 100 is equal to or slightly larger than the outer diameter of the stent. For example, the diameter of themembrane 100 is 1 to 1.1 times the outer diameter of the stent. In this way, during the whole process from the collapsed state to the unfolded state, the deployedmembrane 100 does not reach or exceed its original shape (original diameter) due to the radial expansion of the stent. Therefore, the stent does not cause circumferential stretching of themembrane 100 . It can be understood that there is no elastic deformation or plastic deformation of themembrane 100 in a naturally unfolded state, and the support is configured so as not to participate in causing the deformation of themembrane 100 .

在本实施例中，覆膜100的材质为TPU(热塑性聚氨酯弹性体橡胶)或者PEBAX材质或者PTFE(聚四氟乙烯)。较佳的，覆膜100采用诸如PEBAX的嵌段聚醚酰胺树脂材料。覆膜100在反复形变下没有机械性能的损失，并且抗疲劳，拥有良好的回弹和弹性回复性能以及精确的尺寸稳定性。进而流体背压作用下形变不会超出塑性变形极限或弹性变形极限，稳定保持泵间隙。In this embodiment, the material of thecovering film 100 is TPU (thermoplastic polyurethane elastomer) or PEBAX or PTFE (polytetrafluoroethylene). Preferably, the coveringfilm 100 is made of block polyetheramide resin material such as PEBAX. Thecoating 100 has no loss of mechanical properties under repeated deformation, is fatigue-resistant, has good rebound and elastic recovery properties, and precise dimensional stability. Furthermore, the deformation under the action of fluid back pressure will not exceed the plastic deformation limit or elastic deformation limit, and the pump clearance can be stably maintained.

支架200的远端形成有多个大致呈T型结构的支腿204，支腿204泵壳大致垂直的杆体2041和腿端2042。远端轴承室6外壁设有容纳槽，容纳槽包括多个大致呈轴向延伸的轴向槽和与多个轴向槽远端接通的周向槽。多个杆体2041分别嵌入对应的轴向槽中，多个腿端2042嵌入周向槽中。远端轴承室6外还套设将支腿204紧紧包裹固定以防止其从容纳槽中弹出的箍套，箍套可以为热缩管经加热后形成，以将连接支腿204束缚在远端轴承室6外壁上，实现二者的防脱固定。The distal end of thebracket 200 is formed with a plurality of substantially T-shapedlegs 204 , thelegs 204 have a substantiallyvertical rod body 2041 and leg ends 2042 . The outer wall of thedistal bearing chamber 6 is provided with accommodating grooves, and the accommodating grooves include a plurality of axial grooves extending substantially in the axial direction and a circumferential groove connected to the distal ends of the plurality of axial grooves. A plurality ofrod bodies 2041 are respectively embedded in corresponding axial grooves, and a plurality of leg ends 2042 are embedded in circumferential grooves. The far-end bearing chamber 6 is also sleeved with a hoop that wraps theleg 204 tightly to prevent it from popping out of the accommodating groove. On the outer wall of theend bearing chamber 6, the anti-off fixing of the two is realized.

支架200具有接触支撑覆膜100的支撑部。在自然展开状态下，至少部分支撑部与覆膜100接触。在工作状态下，至少部分支撑部与覆膜100分离。Thebracket 200 has a support portion that contacts and supports themembrane 100 . In a naturally unfolded state, at least part of the supporting portion is in contact with thecovering film 100 . In a working state, at least part of the supporting part is separated from the coveringfilm 100 .

具体的，泵壳在叶轮旋转驱动血液流动的状态下，覆膜100在流体背压作用下，部分褶皱被拉平，或者发生弹性变形或塑形变形，内径增大至与支撑部分离。而在覆膜100 本身的强韧性作用下，限制了形变增大率，即使发生弹性形变或塑性形变使得覆膜100 周向伸长，但该伸长率的变化小于3％，周向伸长变化较小，进而在工作状态下依然能维持叶轮与覆膜100之间的间隔间隙，保持泵效的持续稳定。Specifically, when the impeller rotates to drive the blood flow in the pump casing, under the action of fluid back pressure, some of the folds of themembrane 100 are flattened, or elastically or plastically deformed, and the inner diameter increases to separate from the supporting part. However, under the action of the toughness of thecoating 100 itself, the deformation increase rate is limited. Even if thecoating 100 is stretched in the circumferential direction due to elastic deformation or plastic deformation, the change of the elongation is less than 3%, and the change of the circumferential elongation is small. Furthermore, the gap between the impeller and thecoating film 100 can still be maintained in the working state, and the pump efficiency can be maintained continuously and stably.

支架200包括大致呈锥形的支架近端202和支架远端203，以及位于支架近端202和支架远端203之间的大致呈圆柱形的支架段201。其中，至少部分轴向长度的支架段 201构成支撑部。覆膜100远端套设于支架段201外，被支架段201接触支撑进而构建形成稳定的圆筒形状的泵壳。覆膜100的远端端面不超出支架段201。Thestent 200 includes a substantially tapered stentproximal end 202 and a stentdistal end 203 , and a substantiallycylindrical stent segment 201 located between the stentproximal end 202 and the stentdistal end 203 . Wherein, at least part of the axial length of thestent segment 201 constitutes a support portion. The distal end of themembrane 100 is sheathed outside thebracket section 201 , and is contacted and supported by thebracket section 201 to form a stable cylindrical pump casing. The distal end surface of thecovering film 100 does not exceed thestent segment 201 .

泵壳从径向收折状态转化到径向展开状态过程中，支撑部和覆膜100之间允许相对移动，覆膜100与诸如支架段201的支撑部产生接触的部位允许改变。支架200与覆膜 100的相对位置固定不发生改变。During the transformation of the pump casing from the radially collapsed state to the radially unfolded state, relative movement between the supporting part and thecoating 100 is allowed, and the contact position between thecoating 100 and the supporting part such as thestent segment 201 is allowed to change. The relative positions of thestent 200 and thecovering film 100 are fixed and do not change.

支撑部与覆膜100之间仅为接触支撑，而无固定连接，进而在覆膜100展开过程中，支撑部与覆膜100之间形成一定程度相对运动，借此实现彼此的期望展开。并且，支撑部对覆膜100提供周向支撑力而不提供径向和周向的相对运动约束，允许覆膜100相对于支撑部产生径向或周向的相对运动，使得覆膜100在展开过程中与支撑部或支架所接触的部位发生改变。There is only contact support between the support part and thecovering film 100 without fixed connection, and a certain degree of relative movement is formed between the supporting part and thecovering film 100 during the unfolding process of thecovering film 100 , thereby realizing the desired unfolding of each other. Moreover, the supporting part provides circumferential supporting force for thecovering film 100 without providing radial and circumferential relative movement constraints, allowing thecovering film 100 to produce radial or circumferential relative movement relative to the supporting part, so that thecovering film 100 is unfolded During the process, the part in contact with the support or bracket changes.

叶轮旋转驱动血液流动状态下，覆膜100主要依靠血液的背压而直径增大，导致覆膜100与支架200分离，并不接触，支架200失去对覆膜100的支撑，进而不参与此时覆膜100的变形。When the impeller rotates to drive blood flow, the diameter of thecoating 100 increases mainly due to the back pressure of the blood, causing thecoating 100 to separate from thestent 200 without contact, and thestent 200 loses support to thecoating 100, and thus does not participate in this process. Deformation of thecoating 100 .

在泵壳由自然展开状态切换至工作状态的过程中，支架200在径向上的增大幅度低于覆膜100在径向上的增大幅度。具体的，支架200的外径增大率在覆膜100内径的增大率以下，或者，支架200的外径增大尺寸小于覆膜100内径的增大尺寸。在泵壳由自然展开状态切换至工作状态的过程中，支架200的外径的增大率不超过2％。进一步地，在泵壳由自然展开状态切换至工作状态的过程中，支架200的外径的增大率不超过1％。During the process of switching the pump casing from the naturally unfolded state to the working state, the increase range of thebracket 200 in the radial direction is lower than the increase range of themembrane 100 in the radial direction. Specifically, the increase rate of the outer diameter of thestent 200 is lower than the increase rate of the inner diameter of themembrane 100 , or, the increased size of the outer diameter of thestent 200 is smaller than the increased size of the inner diameter of themembrane 100 . During the process of switching the pump casing from the naturally expanded state to the working state, the increase rate of the outer diameter of thebracket 200 does not exceed 2%. Further, in the process of switching the pump casing from the naturally expanded state to the working state, the increase rate of the outer diameter of thebracket 200 does not exceed 1%.

在如图3至图9所示的可行的实施例中，为使得支架不参与引起覆膜100的弹性或塑性变形，限制支架200在叶轮工作转速范围下的形变量，泵壳还设有用于限制支架200 在径向上扩展的抗扩展元件300。在工作状态下，设置抗扩展元件300的支架200的外径小于未设置抗扩展元件300的情况下的外径。In the feasible embodiment shown in Fig. 3 to Fig. 9, in order to prevent the support from participating in causing the elastic or plastic deformation of themembrane 100, and limit the deformation of thesupport 200 in the impeller operating speed range, the pump casing is also provided with a Theanti-expansion element 300 restricts the expansion of thestent 200 in the radial direction. In a working state, the outer diameter of thestent 200 provided with theanti-expansion element 300 is smaller than that without theanti-expansion element 300 .

在本实施例中，支架200的自然展开状态被抗扩展元件300限制。也就是说，支架200径向扩张会导致抗扩展元件300被拉伸。但是，一旦抗扩展元件300被拉伸至一定程度，支架不能再继续扩展时，支架达到最大直径。In this embodiment, the natural deployed state of thestent 200 is constrained by theanti-expansion element 300 . That is, radial expansion of thestent 200 causes theanti-expansion elements 300 to be stretched. However, once theanti-expansion element 300 is stretched to a certain extent, the stent reaches a maximum diameter when the stent cannot continue to expand.

流体背压影响抗扩展元件300及支架200的径向扩展，但其径向扩展幅度被限制，其扩展幅度低于覆膜100的径向扩展幅度。在工作状态下，抗扩展元件300限制至少部分支撑部的径向扩展，使其与覆膜100分离。在具备抗扩展元件300的基础上，抗扩展元件300限制支架200在径向上的增大幅度低于覆膜100在径向上的增大幅度。The fluid back pressure affects the radial expansion of theanti-expansion element 300 and thestent 200 , but the radial expansion range is limited, and the expansion range is lower than the radial expansion range of thecoating 100 . In the working state, theanti-expansion element 300 limits the radial expansion of at least part of the support portion, separating it from themembrane 100 . On the basis of having theanti-expansion element 300 , theanti-expansion element 300 limits the expansion range of thestent 200 in the radial direction to be lower than the expansion range of thecovering film 100 in the radial direction.

抗扩展元件300的直径小于覆膜100的直径。抗扩展元件300可以设在支架内侧，也可以设在支架外侧。抗扩展元件300在覆膜100内围绕于支架200设置。具体的，抗扩展元件300围绕于支架段201设置。The diameter of theanti-expansion element 300 is smaller than the diameter of themembrane 100 . Theanti-expansion element 300 can be set on the inside of the stent or on the outside of the stent. Theanti-expansion element 300 is disposed around thestent 200 within thegraft 100 . Specifically, theanti-expansion element 300 is arranged around thestent segment 201 .

抗扩展元件300包括固定套设在支架段201外的箍环。箍环可以焊接或者卡接固定在支架段201外。如图3至图7所示的实施例，多个箍环分散套设在支架段201外。如图8、图9所示的实施例，单个箍环(箍套)居中套设在支架段201外。箍环为金属或其他抗扩展材质，其周向抗扩展变形能力强于支架，甚至强于覆膜100，进而在工作状态下，在抗扩展元件300作用下，支架的径向增大率更小，借此与径向进一步扩展的覆膜100分离，互不接触。Theanti-expansion element 300 includes a hoop fixedly sleeved on the outside of thestent segment 201 . The hoop can be fixed outside thebracket section 201 by welding or clamping. In the embodiment shown in FIGS. 3 to 7 , a plurality of hoops are scattered and sleeved on the outside of thebracket segment 201 . In the embodiment shown in FIG. 8 and FIG. 9 , a single hoop (hoop) is centrally sheathed outside thebracket segment 201 . The hoop is made of metal or other anti-expansion material, and its ability to resist expansion and deformation in the circumferential direction is stronger than that of the stent, even stronger than that of thecoating 100. Furthermore, under the action of theanti-expansion element 300 in the working state, the radial expansion rate of the stent is smaller, In this way, they are separated from thecoating 100 that further expands in the radial direction and do not contact each other.

应该理解，以上描述是为了进行图示说明而不是为了进行限制。通过阅读上述描述，在所提供的示例之外的许多实施方式和许多应用对本领域技术人员来说都将是显而易见的。因此，本教导的范围不应该参照上述描述来确定，而是应该参照所附权利要求以及这些权利要求所拥有的等价物的全部范围来确定。出于全面之目的，所有文章和参考包括专利申请和公告的公开都通过参考结合在本文中。在前述权利要求中省略这里公开的主题的任何方面并不是为了放弃该主体内容，也不应该认为发明人没有将该主题考虑为所公开的发明主题的一部分。It should be understood that the foregoing description is for purposes of illustration and not limitation. Many implementations and many applications other than the examples provided will be apparent to those of skill in the art from reading the above description. The scope of the present teachings, therefore, should be determined not with reference to the above description, but should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are hereby incorporated by reference for completeness. The omission from the preceding claims of any aspect of the subject matter disclosed herein is not intended to be a disclaimer of such subject matter, nor should it be considered that the inventors did not consider the subject matter to be part of the disclosed inventive subject matter.

Claims (17)

1. An impeller for a catheter pump, the impeller being receivable within a pump housing of the catheter pump, comprising a hub and blades provided on the hub; the blade is provided with a blade top, a blade root arranged on the hub and a reverse-folding part positioned between the blade root and the blade top; the impeller has a natural deployed state when not rotating in which the blade root extends obliquely in a radial direction in a first circumferential direction toward the inflected section, and the inflected section extends obliquely in a radial direction in a second circumferential direction opposite to the first circumferential direction toward the blade tip.

2. The impeller of claim 1, wherein the impeller has an operating condition when rotating corresponding to a maximum operating speed; and the impeller is switched to a working state from the natural unfolding state, and the outer diameter of the blade is increased by less than 0.5mm.

3. An impeller according to claim 2 wherein the impeller switches from the naturally deployed state to the operational state, the outer diameter of the blades increasing by less than 0.3mm.

4. An impeller according to claim 2, wherein the impeller is switched from the naturally deployed state to the operational state, the outer diameter of the blades increasing by less than 0.1mm.

5. The impeller of claim 1, wherein the blade comprises a first portion between the blade root and the inflection, a second portion between the inflection and the tip; the radial length of the first portion is greater than 0.5 times the radial length of the second portion.

6. The impeller of claim 5, wherein the radial length of the first portion is greater than the radial length of the second portion.

7. The impeller of claim 1 wherein said blade includes a first portion between said blade root and said reverse fold, a second portion between said reverse fold and a blade tip; the maximum thickness of the second portion is greater than 0.7 times the maximum thickness of the first portion; the blades are provided with concave incident flow surfaces and convex back flow surfaces which are opposite to each other; the thickness direction is the normal direction of the contour line of the concave incident flow surface or the convex back flow surface on the cross section.

8. The impeller of claim 7, wherein the maximum thickness of the second portion is greater than the maximum thickness of the first portion.

9. The impeller of claim 1 wherein said blade includes a first portion between said blade root and said reverse fold, a second portion between said reverse fold and a blade tip; the cross-sectional area of the first portion is greater than 0.5 times the cross-sectional area of the second portion.

10. An impeller according to claim 9, wherein the cross-sectional area of the first portion is more than 0.8 times the cross-sectional area of the second portion.

11. The impeller of claim 1, wherein, in a cross-section of the blade, a tangent to the inflection passes through a center of the hub; the blade comprises a first part positioned between the blade root and the reverse fold, and a second part positioned between the reverse fold and the blade tip; the length of the first portion in the direction perpendicular to the tangent is 0.3 times or more the length of the second portion in the direction perpendicular to the tangent.

12. The impeller of claim 11, wherein the length of the first portion perpendicular to the tangential direction is more than 0.5 times the length of the second portion perpendicular to the tangential direction.

13. The impeller of claim 1, wherein the blade comprises a first portion between the blade root and the inflection, a second portion between the inflection and the tip; the blades are provided with concave flow-facing surfaces and convex flow-backing surfaces which are opposite;

wherein, any point on the concave upstream surface or the convex downstream surface of the first part defines that the tangent of the any point has a tangent vector far away from the second part

The tangent line of any point has a contact point with the outer contour line of the hub, and the center of the hub is defined to have a ray vector facing the contact point

(ii) a The tangent vector

And the ray vector

The included angle beta therebetween is greater than 90 degrees and less than 180 degrees.

14. An impeller according to claim 13, wherein a point on the concave flow-facing surface or convex flow-backing surface of the first portion has a larger angle of β closer to the turn-back.

15. An impeller according to claim 13, wherein the blade root is provided with a rounded transition between the concave upstream surface and the hub and/or the blade root is provided with a rounded transition between the convex downstream surface and the hub.

16. A catheter pump impeller, which is receivable within a pump housing of the catheter pump, comprising a hub and blades provided thereon; the blade is provided with a blade top, a blade root arranged on the hub and a reverse-folding part positioned between the blade root and the blade top; the impeller has a natural developed state when not rotating, in which the blade root extends obliquely in a radial direction toward the inflected section in a first circumferential direction opposite to the impeller rotation direction, and the inflected section extends obliquely in a radial direction toward the blade tip in a second circumferential direction opposite to the first circumferential direction, on a cross section where the blade has the largest outer diameter.

17. A catheter pump comprising:

a motor;

a conduit;

the driving shaft penetrates through the catheter, and the near end of the driving shaft is in transmission connection with the output shaft of the motor;

a pump body deliverable through the catheter to a desired location of a heart to pump blood, comprising: an impeller according to any one of claims 1 to 16 and a pump casing which houses the impeller; the pump housing is connected to the distal end of the catheter and the impeller is connected to the distal end of the drive shaft.

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