Impeller, in-vitro blood pump, manufacturing method of in-vitro blood pump and hemolytic property verification method

Abstract

The embodiment of the invention relates to the technical field of medical instruments, and discloses an impeller which comprises an impeller shell, main blades and splitter blades, the impeller shell is a rotating body with a rotating axis, the impeller shell is provided with a mounting surface, and the main blades and the splitter blades are alternately arranged on the mounting surface around the rotating axis; the inlet angle of the main blade is different from the inlet angle of the splitter blade. The inlet angles of the main blades and the splitter blades on the impeller are reasonably configured, so that the attack angle of inlet blood flow can be reduced, the mechanical effect of the main blades and the splitter blades on blood in the rotating process is optimized, flow separation and flow loss of the blood flow are reduced, damage to the blood of a patient in the operation process of the in-vitro blood pump is reduced, and the service life of the in-vitro blood pump is prolonged. Therefore, the hemolysis risk is reduced. The invention further discloses an in-vitro blood pump, a manufacturing method of the in-vitro blood pump and a hemolytic performance verification method.

Description

Technical Field

[0001] The embodiments of the present invention relate to the technical field of medical devices, and in particular to an impeller, an extracorporeal blood pump, a manufacturing method thereof, and a method for verifying hemolytic performance. Background Art

[0002] Blood pumps are medical devices primarily used to control blood flow within the human body. They are widely used in the treatment of various heart conditions. Traditional single-point or dual-point blood pumps with bearings can cause red blood cells to rupture during operation due to mechanical bearing friction, leading to hemolysis. This can affect or even endanger patient safety during clinical surgery.

[0003] Because centrifugal magnetic levitation blood pumps lack mechanical bearings, they can avoid hemolysis caused by mechanical bearing friction during operation. However, the high-speed rotation of the impeller in existing centrifugal magnetic levitation blood pumps subjects the patient's blood to significant shear stress, which damages the blood and leads to hemolysis. Therefore, there is an urgent need in the art for an impeller with improved hemolysis characteristics to minimize damage to the patient's blood during operation and reduce the risk of hemolysis. Summary of the Invention

[0004] An object of the embodiments of the present invention is to provide an impeller that can reduce the damage to the patient's blood during the operation of a blood pump, thereby reducing the risk of hemolysis.

[0005] In order to solve the above technical problems, the first aspect of the present invention provides an impeller, comprising:

[0006] An impeller housing, main blades and splitter blades, wherein the impeller housing is a rotating body having a rotation axis, and the impeller housing has a mounting surface, and the main blades and the splitter blades are alternately arranged on the mounting surface around the rotation axis; the inlet angle of the main blades is different from the inlet angle of the splitter blades.

[0007] Optionally, the inlet angle of the main blade is greater than the inlet angle of the splitter blade; preferably, the inlet angle of the main blade is 25 degrees to 44 degrees, and the inlet angle of the splitter blade is 20 degrees to 30 degrees.

[0008] Optionally, the inlet angle of the main blade is smaller than the outlet angle of the main blade; and / or the inlet angle of the splitter blade is smaller than the outlet angle of the splitter blade.

[0009] Optionally, the outlet angle of the main blade is equal to the outlet angle of the splitter blade; preferably, the outlet angle of the main blade is 62 degrees to 78 degrees.

[0010] Optionally, the main blade includes a first blade body, a first inner edge portion and a first outer edge portion, the first blade body is fixed to the mounting surface, the first inner edge portion extends from one end of the first blade body close to the rotation axis, and the first outer edge portion extends from one end of the first blade body away from the rotation axis; the height of the first inner edge portion from the vertex in the direction of the rotation axis to the mounting surface is greater than the height of the first outer edge portion from the vertex in the direction of the rotation axis to the mounting surface; preferably, the distance between the first inner edge portion and the mounting surface is greater than the distance between the first outer edge portion and the mounting surface; preferably, the height between the vertex in the direction of the rotation axis and the mounting surface of the first inner edge portion is 9 mm to 12 mm; preferably, the edge of the first inner edge portion close to the mounting surface is the first bottom edge, and the distance from the first bottom edge to the mounting surface in the direction of the rotation axis is 2.2 mm to 5.5 mm.

[0011] Optionally, the splitter blade includes a second blade body and a second outer edge portion, the second blade body is fixed to the mounting surface, the second outer edge portion extends from one end of the second blade body away from the rotation axis, and the height from the vertex of the second blade body in the direction of the rotation axis to the mounting surface is greater than the height from the vertex of the second outer edge portion in the direction of the rotation axis to the mounting surface; preferably, the height from the vertex of the second blade body in the direction of the rotation axis to the mounting surface is 8 mm to 11 mm; preferably, the main blade includes a first blade body, a first inner edge portion and a first outer edge portion, the first blade body is fixed to the mounting surface, the first inner edge portion extends from one end of the first blade body close to the rotation axis, and the first outer edge portion extends from one end of the first blade body away from the rotation axis; the impeller housing is an annular cylinder, the edges of the first blade body and the second blade body away from the rotation axis are tangent to the outer edge of the impeller housing, the edges of the first outer edge portion and the second outer edge portion close to the mounting surface are both second bottom edges, and the distance between the second bottom edge and the mounting surface is 0.6 mm to 2.2 mm.

[0012] Optionally, in the direction perpendicular to the rotation axis, the radial dimension of the main blade is larger than the radial dimension of the splitter blade, and the diameter of the inner normal circle of multiple main blades is smaller than the diameter of the inner normal circle of multiple splitter blades; preferably, the diameter of the inner normal circle of multiple main blades is 9.8 mm to 13.2 mm; and / or, the diameter of the inner normal circle of multiple splitter blades is 15.8 mm to 18.6 mm; preferably, the outer normal circle of multiple main blades coincides with the outer normal circle of multiple splitter blades.

[0013] Optionally, the impeller housing is an annular cylinder, and the radial thickness of the impeller housing is 8 mm to 18 mm; and / or, the impeller housing is an annular cylinder, and the height of the impeller housing along the direction of the rotation axis is 12 mm to 24 mm.

[0014] Optionally, cross sections of the main blade and the splitter blade perpendicular to the rotation axis are both arc-shaped planes; and / or the surface area of the main blade is greater than the surface area of the splitter blade.

[0015] Optionally, the top surface of the main blade has a first slope surface and a second slope surface arranged radially, the first slope surface is located on the side of the second slope surface close to the rotation axis, and the slope of the first slope surface is greater than the slope of the second slope surface; or, the top surface of the main blade is a smooth curved surface that extends continuously away from the rotation axis; and / or, the top surface of the splitter blade has a third slope surface and a fourth slope surface arranged radially, the third slope surface is located on the side of the fourth slope surface close to the rotation axis, and the slope of the third slope surface is greater than the slope of the fourth slope surface; or, the top surface of the splitter blade is a smooth curved surface that extends continuously away from the rotation axis.

[0016] A second aspect of the present invention provides an extracorporeal blood pump, comprising:

[0017] A driving device, a pump casing and any of the above impellers; the pump casing is fixed to the driving device, the pump casing includes an inlet and an outlet that are connected to each other, the internal space of the pump casing forms a main flow channel, the impeller is accommodated in the pump casing and is driven by the driving device to rotate around a rotation axis to pump blood from the inlet to the outlet.

[0018] Optionally, the pump casing further has a guide cone protruding along the rotation axis toward the interior of the pump casing, and a lower cylinder supporting the guide cone; the impeller is arranged around the guide cone, and the lower cylinder is a concave structure to form a coupling cavity, and the drive device has an output shaft, and when the pump casing is connected to the drive device, the output shaft extends into the coupling cavity; preferably, the guide cone includes a first curved surface, and a second curved surface connected to the first curved surface; the first curved surface is a convex curved surface extending from the top of the guide cone in a direction away from the rotation axis, and the second curved surface is a concave curved surface extending from the first curved surface in a direction away from the rotation axis; more preferably, the tangent of the first curved surface at the junction of the first curved surface and the second curved surface coincides with the tangent of the second curved surface at the junction of the first curved surface and the second curved surface.

[0019] Optionally, the height of the guide cone is 5 mm to 7 mm; and / or the cone angle of the guide cone is 90 degrees to 115 degrees.

[0020] Optionally, the pump casing further includes an outer annular wall arranged around the lower cylinder, and a connecting wall connecting the lower cylinder and the outer annular wall, the lower cylinder, the connecting wall and the outer annular wall forming an annular receiving groove; the impeller housing of the impeller is an annular cylinder and is located in the annular receiving groove; there is a first gap between the outer wall of the impeller housing and the outer annular wall, a second gap between the bottom wall of the impeller housing and the connecting wall, and a third gap between the inner wall of the impeller housing and the lower cylinder; preferably, the width of the first gap is 0.5 mm to 0.9 mm; and / or, the width of the second gap is 0.8 mm to 1.5 mm; and / or, the width of the third gap is 0.3 mm to 0.9 mm.

[0021] A third aspect of the present invention further provides a method for manufacturing the extracorporeal blood pump, comprising:

[0022] S401. Combine computational fluid dynamics software and hemolysis calculation model to establish a blood pump hemolysis performance calculation platform;

[0023] S402. Providing a basic model of an extracorporeal blood pump and obtaining current structural parameters of the basic model;

[0024] S403. Calculating the current structural parameters of the basic model through the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the basic model;

[0025] S404. Determine whether the hemolytic characteristic data meets the preset requirements;

[0026] If not, adjust the structural parameters based on the pump design theory and replace the current structural parameters of the base model with new structural parameters;

[0027] Repeat S403-S405 until the hemolysis characteristic data meets the preset requirements;

[0028] S406. If yes, manufacture an extracorporeal blood pump based on the structural parameters corresponding to the hemolytic characteristic data that meets the preset requirements.

[0029] A fourth aspect of the present invention further provides a method for verifying the hemolytic performance of the above-mentioned extracorporeal blood pump, comprising:

[0030] Combining computational fluid dynamics software and hemolysis calculation models, a blood pump hemolysis performance calculation platform was established;

[0031] Providing an extracorporeal blood pump, and obtaining structural parameters of the extracorporeal blood pump;

[0032] Calculating the structural parameters by using the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the extracorporeal blood pump;

[0033] Verify whether the hemolysis characteristic data conforms to the preset data.

[0034] Compared with the prior art, the impeller of the embodiment of the present invention can reduce the angle of attack of the inlet blood flow by rationally configuring the inlet angles of the main blades and the diverter blades on the impeller, optimize the mechanical effect of the main blades and the diverter blades on the blood during rotation, reduce the flow separation and flow loss of the blood flow, and reduce the damage to the patient's blood caused by the extracorporeal blood pump during operation, thereby reducing the risk of hemolysis. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] One or more embodiments are exemplarily illustrated by pictures in the corresponding drawings. These exemplifications do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements. Unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0036] Figure 1 1 is a schematic diagram of the three-dimensional structure of an impeller according to an embodiment of the present invention;

[0037] Figure 2 yes Figure 1 A side view schematic diagram of

[0038] Figure 3 yes Figure 1 Schematic top view of

[0039] Figure 4 is a schematic diagram of the three-dimensional structure of a driving device according to an embodiment of the present invention;

[0040] Figure 5 1 is a schematic diagram of the three-dimensional structure of a pump casing according to an embodiment of the present invention;

[0041] Figure 6 yes Figure 5 A side view schematic diagram of

[0042] Figure 7 1 is a schematic diagram of the three-dimensional structure of the lower side of the pump casing of an embodiment of the present invention;

[0043] Figure 8 yes Figure 5 Schematic diagram of the structure explosion along the OO' line;

[0044] Figure 9 yes Figure 6 Schematic cross-sectional view of ;

[0045] Figure 10 yes Figure 9 Enlarged view of the middle S1 region;

[0046] Figure 11 is a flow-lift simulation curve of an extracorporeal blood pump according to an embodiment of the present invention;

[0047] Figure 12 is a flow-hemolysis characteristic simulation curve of the extracorporeal blood pump according to an embodiment of the present invention;

[0048] Figure 13 is a schematic flow chart of a method for manufacturing an extracorporeal blood pump according to an embodiment of the present invention;

[0049] Figure 14 4 is a flow chart of a method for verifying the hemolytic characteristics of an extracorporeal blood pump according to an embodiment of the present invention. DETAILED DESCRIPTION

[0050] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, each embodiment of the present invention will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will appreciate that in each embodiment of the present invention, many technical details are provided to help readers better understand the present application. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed in the present application can still be implemented.

[0051] In the embodiments of the present invention, terms such as "upper," "lower," "left," "right," "front," "back," "top," "bottom," "inner," "outer," "center," "vertical," "horizontal," "transverse," and "longitudinal" to indicate directions or positions are based on the directions or positions shown in the accompanying drawings. These terms are primarily intended to better describe the present invention and its embodiments and are not intended to limit the devices, elements, or components indicated to having a specific direction, or to being constructed or operated in a specific direction.

[0052] Furthermore, some of the above terms may be used to express other meanings besides indicating a position or location. For example, the term "on" may also be used to indicate a dependency or connection in certain circumstances. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0053] Furthermore, the terms "installed," "set," "provided with," "opened," "connected," and "connected" should be interpreted broadly. For example, they can refer to fixed connections, removable connections, or integral structures; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; or internal communication between two devices, elements, or components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on specific circumstances.

[0054] Furthermore, the terms "first," "second," etc., are primarily used to distinguish between different devices, elements, or components (which may or may not be of the same type and configuration), and are not intended to indicate or imply the relative importance or quantity of the devices, elements, or components indicated. Unless otherwise specified, "plurality" means two or more.

[0055] It should be noted that, in the present invention, unless otherwise specified, "axial" generally refers to the extension direction of the rotation axis when the impeller rotates, "radial" generally refers to the radial direction of a circle perpendicular to the extension direction of the rotation axis and with the point through which the rotation axis passes as the center, and "circumferential" generally refers to the circumferential direction surrounding the rotation axis.

[0056] During cardiac surgery, blood pumps are important power devices for maintaining human blood circulation. Implantable blood pumps are generally devices for ventricular assist and have poor scalability. Extracorporeal blood pumps can add membrane lungs and expand into ECMO (Extracorporeal Membrane Oxygenation) systems. In traditional blood pumps with bearings, the friction caused by the rotation of the bearings during operation will damage the patient's blood and cause hemolysis. The use of centrifugal magnetic levitation blood pumps can avoid the impact of bearing friction on the blood. However, the impeller blades of the centrifugal magnetic levitation blood pump are designed unreasonably, causing the blood to be subjected to greater shear stress when passing through the impeller blades, which can easily cause hemolysis.

[0057] In order to solve the above technical problems, one embodiment of the present invention provides an impeller, comprising: an impeller casing, main blades and splitter blades, the impeller casing being a rotating body having a rotation axis, the impeller casing also having a mounting surface, the main blades and the splitter blades being alternately arranged on the mounting surface around the rotation axis; the inlet angle of the main blades is different from the inlet angle of the splitter blades.

[0058] One embodiment of the present invention also provides an extracorporeal blood pump, comprising: a driving device, a pump casing and the above-mentioned impeller; the pump casing is fixed to the driving device, the pump casing includes an inlet and an outlet that are connected to each other, the internal space of the pump casing forms a main flow channel, the impeller is accommodated in the pump casing, and is driven by the driving device to rotate around a rotation axis to pump blood from the inlet to the outlet.

[0059] One embodiment of the present invention further provides a method for manufacturing the extracorporeal blood pump, comprising: S401. establishing a blood pump hemolysis performance calculation platform by combining computational fluid dynamics software and a hemolysis calculation model;

[0060] S402. Providing a basic model of an extracorporeal blood pump and obtaining current structural parameters of the basic model;

[0061] S403. Calculating the current structural parameters of the basic model through the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the basic model;

[0062] S404. Determine whether the hemolytic characteristic data meets the preset requirements;

[0063] S405. If not, adjust the structural parameters in combination with the water pump design theory, and replace the current structural parameters of the basic model with new structural parameters.

[0064] One embodiment of the present invention further provides a method for verifying the hemolytic performance of an extracorporeal blood pump, comprising: establishing a blood pump hemolytic performance calculation platform by combining computational fluid dynamics software and a hemolytic calculation model;

[0065] Providing an extracorporeal blood pump, and obtaining structural parameters of the extracorporeal blood pump;

[0066] Calculating the structural parameters by using the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the extracorporeal blood pump;

[0067] Verify whether the hemolysis characteristic data conforms to the preset data.

[0068] The impeller of the embodiment of the present invention can reduce the angle of attack of the inlet blood flow by rationally configuring the inlet angles of the main blades and the diverter blades on the impeller, optimize the mechanical effects of the main blades and the diverter blades on the blood during rotation, reduce the flow separation and flow loss of the blood flow, and reduce the damage to the patient's blood caused by the extracorporeal blood pump during operation, thereby reducing the risk of hemolysis.

[0069] The implementation details of the impeller of this embodiment are described in detail below. The following content is only provided for ease of understanding and is not necessary for implementing this solution.

[0070] See also Figures 1 to 3 The impeller 100 of this embodiment includes: an impeller housing 110, main blades 120 and splitter blades 130. The impeller housing 110 is a rotating body having a rotation axis OO'. The impeller housing 110 also has a mounting surface 111. The main blades 120 and the splitter blades 130 are alternately arranged on the mounting surface 111 around the rotation axis OO'; the inlet angle α1 of the main blades 120 is different from the inlet angle α2 of the splitter blades 130.

[0071] In this embodiment, the impeller housing 110 is an annular cylinder having a radial thickness of 8 to 18 mm. Alternatively, the impeller housing 110 is an annular cylinder having a height along the rotation axis OO' of 12 to 24 mm. The annular cylinder shape of the impeller housing 110 reduces the force acting on the blood during rotation, thereby reducing hemolysis caused by the force between the impeller housing 110 and the blood.

[0072] In this embodiment, the cross-sections of the main blade 120 and the splitter blade 130 perpendicular to the rotation axis OO' are both arc-shaped planes. And / or, the surface area of the main blade 120 is greater than the surface area of the splitter blade 130. Specifically, the main blade 120 and the splitter blade 130 are both straight blades with arc-shaped bends. It should be noted that the "straight blades" here mean that the main blade 120 and the splitter blade 130 are both arranged perpendicular to the mounting surface 111, that is, they extend axially. It should be noted that the main blade 120 and the splitter blade 130 may not be strictly perpendicular to the mounting surface 111, but may have an angle of a certain size. For example, the angle range between all blades and the mounting surface 111 may be within the range of 90°±5°.

[0073] More specifically, the curvature of the working and back surfaces of all blades is the same, meaning that the thickness of all blades is uniform. It should be understood that the working surface of a blade is the side of the blade that contacts and propels blood during operation of the extracorporeal blood pump. Furthermore, the mid-camber lines of the main blades 120 and the diverter blades 130 are convex toward the direction of rotation of the impeller 100. Similarly, the surfaces of all blades are smooth.

[0074] It can be understood that setting the main blade 120 and the diverter blade 130 as arc-shaped straight blades can increase the radial dimensions of the main blade 120 and the diverter blade 130, thereby increasing the effective area of the main blade 120 and the diverter blade 130 on the blood during the operation of the extracorporeal blood pump, reducing the flow rate of blood exposed per unit time, and reducing the risk of hemolysis.

[0075] See again Figure 2In this embodiment, the top surface of the main blade 120 has a first slope and a second slope arranged in a radial direction, the first slope is located on the side of the second slope close to the rotation axis OO', and the slope of the first slope is greater than the slope of the second slope. In other feasible embodiments, the top surface of the main blade 120 is a smooth curved surface that extends continuously away from the rotation axis OO'. In another embodiment, the main blade 120 may also include a third slope, and the third slope is located on the side of the second slope away from the rotation axis OO', and the slope of the third slope is further smaller than the slope of the second slope. It can be understood that the main blade 120 can also have more slopes, and all slopes are connected in sequence along the radial direction, and the slopes of all slopes decrease in sequence from the direction away from the rotation axis OO'.

[0076] In this embodiment, the top surface of the splitter blade 130 has a fourth slope and a fifth slope arranged radially. The fourth slope is located on the side of the fifth slope closer to the rotation axis OO', and the slope of the fourth slope is greater than the slope of the fifth slope. Alternatively, the top surface of the splitter blade 130 is a smooth curved surface that extends continuously away from the rotation axis OO'. Similarly, the splitter blade 130 may have more slopes, all of which are connected in sequence radially, with the slopes of all slopes decreasing in the direction away from the rotation axis OO'.

[0077] See again Figure 3 In this embodiment, in a direction perpendicular to the rotation axis OO', the radial dimension of the main blades 120 is greater than the radial dimension of the splitter blades 130, and the diameter of the inner normal circle 121 of the main blades 120 is smaller than the diameter of the inner normal circle 131 of the splitter blades 130. Preferably, the diameter of the inner normal circle 121 of the main blades 120 is between 9.8 mm and 13.2 mm. And / or, the diameter of the inner normal circle 131 of the splitter blades 130 is between 15.8 mm and 18.6 mm. Preferably, the outer normal circle 122 of the main blades 120 and the outer normal circle 132 of the splitter blades 130 coincide.

[0078] In this embodiment, the inlet angle α1 of the main blade 120 is greater than the inlet angle α2 of the splitter blade 130. Preferably, the inlet angle α1 of the main blade 120 is 25 to 44 degrees, and the inlet angle α2 of the splitter blade 130 is 20 to 30 degrees. For example, the inlet angle α1 of the main blade 120 can be 25°, 34°, 36°, 40°, 44°, or other values, and the inlet angle α2 of the splitter blade 130 can be 20°, 22°, 26°, 28°, 30°, or other values.

[0079] The inlet angle α1 of the main blade 120 and the inlet angle α2 of the diverter blade 130 are both not less than 20°, and both are set to be larger, and the inlet angle α1 of the main blade 120 is made larger than the inlet angle α2 of the diverter blade 130, which can reduce the angle of attack of the inlet blood flow, optimize the mechanical effect of the main blade 120 and the diverter blade 130 on the blood during rotation, reduce the flow separation and flow loss of the blood flow, and reduce the damage to the patient's blood during operation of the extracorporeal blood pump equipped with the impeller 100, thereby reducing the risk of hemolysis.

[0080] In this embodiment, the inlet angle α1 of the main blade 120 is smaller than the outlet angle β1 of the main blade 120. And / or, the inlet angle α2 of the splitter blade 130 is smaller than the outlet angle β2 of the splitter blade 130. In other words, the inlet angle α1 of the main blade 120 is smaller than the outlet angle β1 of the main blade 120. Alternatively, the inlet angle α2 of the splitter blade 130 is smaller than the outlet angle β2 of the splitter blade 130. Alternatively, the inlet angle α1 of the main blade 120 is smaller than the outlet angle β1 of the main blade 120, and at the same time, the inlet angle α2 of the splitter blade 130 is smaller than the outlet angle β2 of the splitter blade 130.

[0081] Furthermore, the outlet angle β1 of the main blade 120 is equal to the outlet angle β2 of the splitter blade 130. Preferably, the outlet angle β1 of the main blade 120 is between 62 degrees and 78 degrees. In other words, the outlet angle β2 of the splitter blade 130 is between 62 degrees and 78 degrees. For example, the outlet angle β1 of the main blade 120 and the outlet angle β2 of the splitter blade 130 can be set to 62 degrees, 66 degrees, 70 degrees, 74 degrees, 78 degrees, or other values.

[0082] It should be noted that, in this embodiment, the inlet angle α of the blade is: the angle between the tangent of the blade's median arc at the intersection with the blade's end face close to the rotation axis OO' and the line connecting the intersection and the center of the inner normal circle of the main blade 120; the outlet angle β of the blade is: the acute angle between the straight line perpendicular to the tangent of the blade's median arc at the intersection with the blade's end face away from the rotation axis OO' and the line connecting the intersection and the center of the inner normal circle of the main blade 120.

[0083] See again Figure 2In this embodiment, the main blade 120 includes a first blade body 123, a first inner edge portion 124, and a first outer edge portion 125. The first blade body 123 is fixed to the mounting surface 111. The first inner edge portion 124 extends from the end of the first blade body 123 close to the rotation axis OO', and the first outer edge portion 125 extends from the end of the first blade body 123 away from the rotation axis OO'. The height H1 from the vertex of the first inner edge portion 124 in the direction of the rotation axis OO' to the mounting surface 111 is greater than the height H2 from the vertex of the first outer edge portion 125 in the direction of the rotation axis OO' to the mounting surface 111. Specifically, the height H1 between the highest point of the first inner edge portion 124 and the mounting surface 111 is greater than the height H2 between the highest point of the first outer edge portion 125 and the mounting surface 111. Preferably, the mounting surface 111 is a plane without any protrusions or depressions on its surface. Thus, when the impeller 100 rotates, the interaction between the mounting surface 111 and the blood can be minimized, thereby improving the hemolytic properties of the impeller 100.

[0084] Preferably, a height H1 from the vertex of the first inner edge portion 124 in the direction of the rotation axis OO' to the mounting surface is 9 mm to 12 mm.

[0085] In this embodiment, a distance H3 between the first inner edge portion 124 and the mounting surface 111 is greater than a distance H4 between the first outer edge portion 125 and the mounting surface 111. Specifically, the bottom of the first inner edge portion 124 and the bottom of the first outer edge portion 125 are both higher than the mounting surface 111, and the distance H3 between the bottom of the first inner edge portion 124 and the mounting surface 111 is greater than the distance H4 between the bottom of the first outer edge portion 125 and the mounting surface 111.

[0086] Further preferably, the edge of the first inner edge portion 124 close to the mounting surface 111 is a first bottom edge 1241 (i.e., the bottom of the first inner edge portion 124), and the distance H3 from the first bottom edge 1241 to the mounting surface 111 in the direction of the rotation axis OO' is 2.2 mm to 5.5 mm. It can be understood that the first inner edge portion 124 is arranged higher than the mounting surface 111, and the distance H3 from the first bottom edge 1241 to the mounting surface 111 accounts for 20% to 50% of the distance H1 from the vertex of the first inner edge portion 124 to the mounting surface 111. Furthermore, the distance H3 between the first bottom edge 1241 and the mounting surface 111 can be arbitrarily selected within the range of 2.2 mm to 5.5 mm (including the endpoint values) according to actual needs, and is not specifically limited here.

[0087] In this embodiment, the splitter blade 130 includes a second blade body 133 and a second outer edge portion 134. The second blade body 133 is fixed to the mounting surface 111. The second outer edge portion 134 extends from one end of the second blade body 133 away from the rotation axis OO'. The height H5 from the vertex of the second blade body 133 in the direction of the rotation axis OO' to the mounting surface 111 is greater than the height H6 from the vertex of the second outer edge portion 134 in the direction of the rotation axis OO' to the mounting surface 111. In this embodiment, the above-mentioned H2 and H6 are equal in size. Preferably, the height H5 from the vertex of the second blade body 133 in the direction of the rotation axis OO' to the mounting surface 111 is 8 mm to 11 mm.

[0088] Preferably, the edges of the first blade body 123 and the second blade body 133 that are distal from the rotation axis OO' are tangent to the outer edge of the impeller housing 110. The edges of the first outer edge portion 124 and the second outer edge portion 134 that are proximal to the mounting surface 111 are both second bottom edges 1242. The distance H4 between the second bottom edge 1242 and the mounting surface 111 is 0.6 mm to 2.2 mm. In other words, the first outer edge portion 125 and the second outer edge portion 134 are both positioned higher than the mounting surface 111, and the distance H4 from the second bottom edge 1242 to the mounting surface 111 accounts for 8% to 30% of the distance H2 from the vertex of the first outer edge portion 125 to the mounting surface 111.

[0089] The second embodiment of the present invention relates to an extracorporeal blood pump, see also Figures 4 to 8 , comprising: a driving device 200, a pump housing 300, and the impeller 100 described in the above embodiment. The pump housing 300 is fixed to the driving device 200, and includes an inlet 311 and an outlet 321 that are interconnected. The internal space of the pump housing 300 forms a main flow channel. The impeller 100 is accommodated in the pump housing 300 and is driven by the driving device 200 to rotate about the above-mentioned rotation axis OO' to pump blood from the inlet 311 to the outlet 321.

[0090] It is understandable that the driving device 200 is disposed on a side of the pump housing 300 away from the inlet 311. In some feasible embodiments, the pump housing 300 can be fixedly connected to the driving device 200 by snap connection, screw connection, adhesive connection or other means.

[0091] In this embodiment, the drive device 200 has an annular columnar accommodating space 210, and the pump housing 300 includes an upper shell 310 and a lower shell 320, and the upper shell 310 and the lower shell 320 are fastened and fixed to enclose the main flow channel. The accommodating space 210 is used to accommodate the lower shell 320. The upper shell 310 is provided with the inlet 311, and the lower shell 320 is provided with the outlet 321. The upper shell 310 and the lower shell 320 can be fixed by means of snap-fitting or the like. The inlet 311 can extend in the axial direction, and the extension direction of the outlet 321 can be set at an angle to the axial direction. Preferably, the extension direction of the outlet 321 is set to be perpendicular to the axial direction, that is, the extension direction of the outlet 321 is perpendicular to the extension direction of the inlet 311.

[0092] It should be noted that both the upper shell 310 and the lower shell 320 are made of non-metallic materials, such as plastic, to minimize interference with the magnetic levitation function of the extracorporeal blood pump. Furthermore, when the upper shell 310 and the lower shell 320 are fastened together, a sealing ring or other structure can be used for sealing. For example, an O-ring can be made of an elastic material such as rubber or silicone. More preferably, they can be made of an elastic material with good biocompatibility.

[0093] See also Figure 7 Furthermore, the lower housing 320 has a receiving cavity 330, and the driving device 200 has an output shaft 220, which extends into the receiving cavity 330. Specifically, an active magnet (not shown) is provided on the output shaft 220, and a driven magnet (not shown) is provided on the impeller housing 110. The driven magnet and the active magnet are magnetically coupled, so that the impeller 100 is suspended in the pump housing 300. When the output shaft 220 drives the active magnet to rotate, the driven magnet, under the action of the active magnet, drives the impeller 100 to rotate, thereby pumping the blood entering the pump housing 300 through the inlet 311 to the outlet 321.

[0094] See also Figure 9 and Figure 10 In this embodiment, the lower housing 320 further includes a guide cone 322 that protrudes toward the interior of the pump housing 300 along the rotation axis OO', and a lower cylindrical body 323 that supports the guide cone 322. The impeller 100 is disposed around the guide cone 322. The lower cylindrical body 323 has a concave structure, forming a coupling cavity 324. The drive device 200 has an output shaft 220. When the pump housing 300 is connected to the drive device 200, the output shaft 220 extends into the coupling cavity.

[0095] Preferably, the guide cone 322 includes a first curved surface 3221 and a second curved surface 3222 connected to the first curved surface 3221. The first curved surface 3221 is a convex curved surface extending from the top of the guide cone 322 in a direction away from the rotation axis OO', and the second curved surface 3222 is a concave curved surface extending from the first curved surface 3221 in a direction away from the rotation axis OO'. Specifically, the guide cone 322 is in the shape of an inverted trumpet as a whole, and its periphery is connected to the periphery of the lower cylinder 323. The main blades 120 and the splitter blades 130 are arranged alternately around the guide cone 322. In this embodiment, the first curved surface 3221 can be a part of a sphere or an ellipsoid, or a part of a non-spherical curved surface, and its convex direction is toward the inlet 311. The curve formed by the cross section of the second curved surface 3222 in the direction parallel to the rotation axis OO' can be a circular arc, an elliptical arc or other smooth curve, and the protrusion direction of the second curved surface 3222 is roughly opposite to the protrusion direction of the first curved surface 3221. In some embodiments, the first curved surface 3221 can preferably be a part of a sphere, and the curve formed by the interface of the second curved surface 3222 can preferably be a circular arc. In this way, the difficulty of forming the guide cone 322 can be reduced, thereby reducing the difficulty of manufacturing the extracorporeal blood pump. By providing the guide cone 322, the blood entering the interior of the pump housing 300 can be drained, and the formation of vortices and high shear stress areas can be avoided to a certain extent. In actual application, the shear effect of the extracorporeal blood pump on the patient's blood can be reduced, reducing the risk of hemolysis.

[0096] More preferably, the tangent line of the first curved surface 3221 at the junction of the first curved surface 3221 and the second curved surface 3222 coincides with the tangent line of the second curved surface 3222 at the junction of the first curved surface 3221 and the second curved surface 3222. In other words, the surface of the guide cone 322 facing the upper shell 310, formed by the first curved surface 3221 and the second curved surface 3222, is a smooth curved surface. Setting the surface of the guide cone 322 as a smooth curved surface can optimize the stress applied to the blood during operation of the extracorporeal blood pump, further reducing the risk of hemolysis.

[0097] In this embodiment, the height H7 of the guide cone 322 is 5 mm to 7 mm. For example, it can be set to 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, or other values, which are not specifically limited in the present invention. In some embodiments, the cone angle of the guide cone 322 is 90 degrees to 115 degrees. For example, it can be 90°, 102°, 104°, 106°, 108°, 110°, 115°, or other values, which are not specifically limited in the present invention.

[0098] It should be noted that the height H7 of the guide cone 322 refers to the axial distance between the vertex of the guide cone 322 and the plane of the mounting surface 111, axially toward the upper shell 310, when the mounting surface 111 is a plane. In actual applications, all outer wall surfaces of the impeller housing 110 (including the mounting surface 111) are configured as smooth surfaces to reduce friction between the impeller 100 and the blood during rotation, avoid blood damage, reduce the risk of hemolysis, and improve the operating efficiency of the extracorporeal blood pump.

[0099] In this embodiment, the lower shell 320 includes an outer annular wall 325 surrounding the lower cylindrical body 323, and a connecting wall 326 connecting the lower cylindrical body 323 and the outer annular wall 325. The lower cylindrical body 323, the connecting wall 326, and the outer annular wall 325 form an annular receiving groove 327. The impeller housing 110 of the impeller 100 is located in the annular receiving groove 327. A first gap G1 is defined between the outer wall of the impeller housing 110 and the outer annular wall 325, a second gap G2 is defined between the bottom wall of the impeller housing 110 and the connecting wall 326, and a third gap G3 is defined between the inner wall of the impeller housing 110 and the lower cylindrical body 323. The first gap G1, the second gap G2, and the third gap G3 are interconnected, forming a U-shaped secondary flow channel. During the operation of the extracorporeal blood pump, blood enters the main channel from the inlet 311, and most of the blood is pumped to the outlet 321 under the rotation of the main blade 120 and the diverter blade 130, thereby leaving the extracorporeal blood pump. Part of the blood enters the secondary channel from the first gap G1, then flows through the second gap G2 and the third gap G3, and enters the main channel again at the third gap G3, and is then pumped to the outlet 321.

[0100] In this embodiment, the width of the first gap G1 is 0.5 mm to 0.9 mm. And / or, the width of the second gap G2 is 0.8 mm to 1.5 mm. And / or, the width of the third gap G3 is 0.3 mm to 0.9 mm. This design can reduce the duration of blood retention in the secondary flow channel, thereby reducing the duration of shear stress on the blood within the secondary flow channel, thereby reducing the risk of hemolysis.

[0101] In this embodiment, the upper shell 310 includes a trumpet portion 312 having a circular outer contour. The trumpet portion 312 extends from the inlet 311 toward the impeller 100 and has an increasing inner diameter. The trumpet portion 312 has a first upper edge and a first lower edge spaced axially apart, with the first upper edge connected to the inlet 311. The lower shell 320 includes a vortex portion 328 and an annular portion 329. The annular portion 329 includes the lower cylinder 323, the outer annular wall 325, and the connecting wall 326. The vortex portion 328 has a second upper edge and a second lower edge spaced axially apart, while the outer annular wall 325 has a third upper edge and a third lower edge spaced axially apart. The second upper edge is connected to the first lower edge, the second lower edge is connected to the third upper edge, and the third lower edge is connected to the connecting wall 326.

[0102] The inlet 311 forms an inlet flow channel 3111, the trumpet portion 312 and the vortex portion 328 form an impeller flow channel 3281 and a vortex flow channel 3282, and the vortex flow channel 3282 is located outside the impeller flow channel 3281. The outlet 321 forms an outlet flow channel 3211. The inlet flow channel 3111, the impeller flow channel 3281, the vortex flow channel 3282, and the outlet flow channel 3211 are interconnected to form the main flow channel. The main blades 120 and the splitter blades 130 are both located in the impeller flow channel 3281.

[0103] Specifically, blood flows from the inlet flow channel 3111 into the impeller flow channel 3281. Under the action of the main blades 120 and the splitter blades 130, the blood flows from the impeller flow channel 3281 into the vortex flow channel 3282, and then enters the outlet flow channel 3211 through the vortex flow channel 3282, thereby achieving blood circulation within the human body. When the blood enters the vortex flow channel 3282 from the impeller flow channel 3281, part of the blood flows into the secondary flow channel and then enters the impeller flow channel 3281 again.

[0104] It can be understood that when the upper shell 310 and the lower shell 320 are assembled, the inclination of the trumpet portion 312 roughly matches the slope of the top surface of the blade.

[0105] See also Figure 11 and Figure 12 , Figure 11 is the flow rate (Q)-head (H) simulation curve of the extracorporeal blood pump, Figure 12 is the flow rate (Q)-hemolysis (NIH) characteristic simulation curve of the extracorporeal blood pump. Figure 11 In the figure, the solid line corresponds to a lift H of 300 mmHg, and the dotted line corresponds to a lift H of 200 mmHg. Figure 12In the figure, the solid line represents the hemolysis characteristic curve of the extracorporeal blood pump at a head of 300 mmHg, and the dashed line represents the hemolysis characteristic curve of the extracorporeal blood pump at a head of 200 mmHg. As can be seen, under the operating conditions of 300 mmHg and a flow rate of 4 L / min, the hemolysis index of the extracorporeal blood pump is 0.017 mg / dL, indicating that the extracorporeal blood pump provided in this embodiment has good hemolysis characteristics.

[0106] The extracorporeal blood pump provided by the present invention optimizes the mechanical effects of the main blade 120 and the diverter blade 130 on the blood during rotation by reasonably configuring the inlet angle of the main blade 120 and the inlet angle of the diverter blade 130, thereby reducing the impact angle of the inlet blood flow, thereby reducing the flow separation and flow loss of the blood flow, and reducing the damage to the patient's blood during operation of the extracorporeal blood pump, thereby reducing the risk of hemolysis.

[0107] Another embodiment of the present invention provides a method for manufacturing an extracorporeal blood pump, such as Figure 13 As shown, including:

[0108] S401. Combine computational fluid dynamics software and hemolysis calculation model to establish a blood pump hemolysis performance calculation platform;

[0109] S402. Providing a basic model of an extracorporeal blood pump and obtaining current structural parameters of the basic model;

[0110] S403. Calculating the current structural parameters of the basic model through the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the basic model;

[0111] S404. Determine whether the hemolytic characteristic data meets the preset requirements;

[0112] If not, adjust the structural parameters based on the pump design theory and replace the current structural parameters of the base model with new structural parameters;

[0113] Repeat S403-S405 until the hemolysis characteristic data meets the preset requirements;

[0114] S406. If yes, manufacture an extracorporeal blood pump based on the structural parameters corresponding to the hemolytic characteristic data that meets the preset requirements.

[0115] The manufacturing method of an extracorporeal blood pump provided in an embodiment of the present invention utilizes computational fluid dynamics software and a hemolysis calculation model to form a blood pump hemolysis performance calculation platform. After designing and obtaining the structural parameters of the extracorporeal blood pump, these parameters can be substituted into the blood pump hemolysis performance calculation platform. The platform then rapidly obtains hemolysis characteristic data for the extracorporeal blood pump corresponding to the structural parameters, thereby rapidly predicting its hemolysis distribution. Compared to existing technologies, this embodiment can rapidly obtain more accurate hemolysis characteristic data for the extracorporeal blood pump that conforms to the hemolysis calculation model, saving the time and cost of manufacturing and testing the actual pump.

[0116] For S401, a blood pump hemolysis performance calculation platform was established by combining computational fluid dynamics software and hemolysis calculation model.

[0117] Specifically, the computational fluid dynamics software can be ANSYS FLUENT, and the hemolysis calculation model can refer to the academic paper "Computational modeling of the Food and Drug Administration's benchmark centrifugal blood pump" (Artificial Organs, 2020, 44: E263-E276) by Bryan C. Good et al.

[0118] For S402, a basic model of an extracorporeal blood pump is provided, and current structural parameters of the basic model are obtained.

[0119] Specifically, a general basic model of an extracorporeal blood pump can be selected and its corresponding structural parameters can be obtained. The current structural parameters include but are not limited to the number, radial size, axial size, inlet angle, outlet angle of both the mainstream blades and the diversion blades, as well as the width and length of the secondary flow channel, impeller housing and other parameters.

[0120] After the structural parameters required for calculation are obtained, S403 is performed. The current structural parameters of the basic model are calculated by the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the basic model.

[0121] Specifically, the current structural parameters can be substituted into the blood pump hemolysis performance calculation platform for calculation to obtain hemolysis characteristic data corresponding to the current structural parameters, that is, corresponding to the basic model. The hemolysis characteristic data can be used to evaluate the hemolysis performance of the extracorporeal blood pump corresponding to the current structural parameters.

[0122] For S404, determine whether the hemolysis characteristic data meets the preset requirements.

[0123] Since the blood pump hemolysis performance calculation platform is combined with the hemolysis calculation model, the blood pump hemolysis performance calculation platform can output corresponding hemolysis performance data based on the obtained hemolysis characteristic data, thereby directly evaluating the hemolysis performance of the extracorporeal blood pump corresponding to the current structural parameters.

[0124] S405. If not, adjust the structural parameters in combination with the water pump design theory, and replace the current structural parameters of the basic model with new structural parameters.

[0125] If the hemolytic performance of the extracorporeal blood pump corresponding to the basic model does not meet the preset requirements, one or more of the above structural parameters can be adjusted according to the water pump design theory to obtain new structural parameters, and the new structural parameters replace the original structural parameters, which are substituted into the blood pump hemolytic performance calculation platform for calculation, and then a judgment is made based on the new results, that is, the above S403-S405 are repeated until the hemolytic characteristic data corresponding to the new structural parameters meet the preset requirements.

[0126] For S406. If yes, manufacture an extracorporeal blood pump based on the structural parameters corresponding to the hemolytic characteristic data that meets the preset requirements.

[0127] When it is determined through the hemolysis characteristic data that the hemolysis performance of the corresponding extracorporeal blood pump meets the requirements, the corresponding extracorporeal blood pump is manufactured according to the structural parameters corresponding to the hemolysis characteristic data.

[0128] It should be noted that the purpose of step S401 is to provide a blood pump hemolysis performance calculation platform that can quickly and accurately evaluate the hemolysis performance of the extracorporeal blood pump. Therefore, the blood pump hemolysis performance calculation platform can also be established after completing step S402. That is, the order of step S401 and step S402 can be adjusted according to actual conditions.

[0129] Another embodiment of the present invention provides a method for verifying the hemolytic characteristics of an in vitro blood pump, such as Figure 14 As shown, including:

[0130] Combining computational fluid dynamics software and hemolysis calculation models, a blood pump hemolysis performance calculation platform was established;

[0131] providing an extracorporeal blood pump and obtaining structural parameters of the extracorporeal blood pump;

[0132] Calculating the structural parameters by using the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the extracorporeal blood pump;

[0133] Verify whether the hemolysis characteristic data conforms to the preset data.

[0134] This embodiment combines computational fluid dynamics software with a hemolysis calculation model to create a blood pump hemolysis performance calculation platform. The structural parameters of the extracorporeal blood pump can be substituted into the platform for calculation to obtain hemolysis performance data corresponding to the structural parameters. This hemolysis performance data can then be verified, thereby verifying the hemolysis performance of the extracorporeal blood pump corresponding to the hemolysis performance data. Compared to traditional verification methods, this embodiment's verification method is more convenient, more efficient, and less costly.

[0135] It is understandable that the extracorporeal blood pump described in the present invention may be a centrifugal magnetic levitation blood pump, or other types of extracorporeal blood pumps.

[0136] The above describes in detail the impeller, extracorporeal blood pump, manufacturing method thereof, and hemolytic performance verification method provided in the embodiments of the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above implementation methods is only used to help understand the ideas of the present invention. There may be changes in the specific implementation methods and application scope. In summary, the contents of this specification should not be understood as limiting the present invention.

Claims

1. An impeller, characterized in that: It includes an impeller housing, main blades and splitter blades. The impeller housing is a rotating body with a rotation axis. The impeller housing has a mounting surface. The main blades and the splitter blades are alternately arranged on the mounting surface around the rotation axis. The inlet angle of the main blades is different from the inlet angle of the splitter blades.

2. The impeller according to claim 1, characterized in that The inlet angle of the main blade is greater than the inlet angle of the splitter blade; Preferably, the inlet angle of the main blade is 25 degrees to 44 degrees, and the inlet angle of the splitter blade is 20 degrees to 30 degrees.

3. The impeller according to claim 1, characterized in that The inlet angle of the main blade is smaller than the outlet angle of the main blade; and / or the inlet angle of the splitter blade is smaller than the outlet angle of the splitter blade.

4. The impeller according to claim 1, characterized in that The outlet angle of the main blade is equal to the outlet angle of the splitter blade; Preferably, the outlet angle of the main blade is 62 degrees to 78 degrees.

5. The impeller according to claim 1, characterized in that The main blade includes a first blade body, a first inner edge portion, and a first outer edge portion, the first blade body being fixed to the mounting surface, the first inner edge portion extending from an end of the first blade body close to the rotation axis, and the first outer edge portion extending from an end of the first blade body away from the rotation axis; a height from a vertex of the first inner edge portion in the direction of the rotation axis to the mounting surface is greater than a height from a vertex of the first outer edge portion in the direction of the rotation axis to the mounting surface; Preferably, the distance between the first inner edge portion and the mounting surface is greater than the distance between the first outer edge portion and the mounting surface; Preferably, the height from the vertex of the first inner edge portion in the direction of the rotation axis to the mounting surface is 9 mm to 12 mm; Preferably, the edge of the first inner edge portion close to the mounting surface is a first bottom edge, and the distance from the first bottom edge to the mounting surface in the direction of the rotation axis is 2.2 mm to 5.5 mm.

6. The impeller according to claim 1, characterized in that The splitter blade includes a second blade body and a second outer edge portion, the second blade body is fixed to the mounting surface, the second outer edge portion extends from an end of the second blade body away from the rotation axis, and the height from the vertex of the second blade body in the direction of the rotation axis to the mounting surface is greater than the height from the vertex of the second outer edge portion in the direction of the rotation axis to the mounting surface; Preferably, the height from the vertex of the second blade body in the direction of the rotation axis to the mounting surface is 8 mm to 11 mm; Preferably, the main blade includes a first blade body, a first inner edge portion and a first outer edge portion, the first blade body is fixed to the mounting surface, the first inner edge portion extends from an end of the first blade body close to the rotation axis, and the first outer edge portion extends from an end of the first blade body away from the rotation axis; the impeller housing is an annular cylinder, the edges of the first blade body and the second blade body away from the rotation axis are tangent to the outer edge of the impeller housing, the edges of the first outer edge portion and the second outer edge portion close to the mounting surface are both second bottom edges, and the distance between the second bottom edge and the mounting surface is 0.6 mm to 2.2 mm.

7. The impeller according to claim 1, characterized in that In a direction perpendicular to the rotation axis, the radial dimension of the main blade is larger than the radial dimension of the splitter blade, and the diameter of the inner normal circle of the plurality of main blades is smaller than the diameter of the inner normal circle of the plurality of splitter blades; Preferably, the diameter of the inner normal circle of the plurality of main blades is 9.8 mm to 13.2 mm; and / or the diameter of the inner normal circle of the plurality of splitter blades is 15.8 mm to 18.6 mm; Preferably, the outer normal circles of the plurality of main blades coincide with the outer normal circles of the plurality of splitter blades.

8. The impeller according to claim 1, characterized in that The impeller housing is an annular cylinder, and the radial thickness of the impeller housing is 8 mm to 18 mm; and / or the impeller housing is an annular cylinder, and the height of the impeller housing along the rotation axis direction is 12 mm to 24 mm.

9. The impeller according to claim 1, characterized in that The cross sections of the main blade and the splitter blade perpendicular to the rotation axis are both arc-shaped planes; and / or the surface area of the main blade is greater than the surface area of the splitter blade.

10. The impeller according to claim 1, characterized in that The top surface of the main blade has a first slope and a second slope arranged in a radial direction, the first slope is located on a side of the second slope closer to the rotation axis, and the slope of the first slope is greater than the slope of the second slope; or the top surface of the main blade is a smooth curved surface that extends continuously away from the rotation axis; and / or, The top surface of the splitter blade has a third slope surface and a fourth slope surface arranged radially, the third slope surface is located on the side of the fourth slope surface close to the rotation axis, and the slope of the third slope surface is greater than the slope of the fourth slope surface; alternatively, the top surface of the splitter blade is a smooth curved surface that extends continuously away from the rotation axis.

11. An extracorporeal blood pump, characterized in that: The invention comprises a driving device, a pump casing and an impeller according to any one of claims 1 to 10; the pump casing is fixed to the driving device, the pump casing comprises an inlet and an outlet which are interconnected, the internal space of the pump casing forms a main flow channel, the impeller is accommodated in the pump casing and is driven by the driving device to rotate around a rotation axis to pump blood from the inlet to the outlet.

12. The extracorporeal blood pump according to claim 11, characterized in that The pump housing further comprises a guide cone protruding along the rotation axis toward the interior of the pump housing, and a lower cylindrical body supporting the guide cone; the impeller is arranged around the guide cone, and the lower cylindrical body is a concave structure to form a coupling cavity; the drive device comprises an output shaft, and when the pump housing is connected to the drive device, the output shaft extends into the coupling cavity; Preferably, the guide cone includes a first curved surface and a second curved surface connected to the first curved surface; the first curved surface is a convex curved surface extending from the top end of the guide cone in a direction away from the rotation axis, and the second curved surface is a concave curved surface extending from the first curved surface in a direction away from the rotation axis; More preferably, a tangent line of the first curved surface at the junction of the first curved surface and the second curved surface coincides with a tangent line of the second curved surface at the junction of the first curved surface and the second curved surface.

13. The extracorporeal blood pump according to claim 12, characterized in that The height of the guide cone is 5 mm to 7 mm; and / or the cone angle of the guide cone is 90 degrees to 115 degrees.

14. The extracorporeal blood pump according to claim 12, characterized in that The pump casing further includes an outer annular wall surrounding the lower cylindrical body, and a connecting wall connecting the lower cylindrical body and the outer annular wall, wherein the lower cylindrical body, the connecting wall and the outer annular wall form an annular receiving groove; the impeller housing of the impeller is an annular cylindrical body and is located in the annular receiving groove; A first gap is defined between the outer side wall of the impeller housing and the outer annular wall, a second gap is defined between the bottom wall of the impeller housing and the connecting wall, and a third gap is defined between the inner side wall of the impeller housing and the lower cylindrical body; Preferably, the width of the first gap is 0.5 mm to 0.9 mm; and / or the width of the second gap is 0.8 mm to 1.5 mm; and / or the width of the third gap is 0.3 mm to 0.9 mm.

15. A method for manufacturing an extracorporeal blood pump according to claim 11, characterized in that: include: S401. Combine computational fluid dynamics software and hemolysis calculation model to establish a blood pump hemolysis performance calculation platform; S402. Providing a basic model of an extracorporeal blood pump and obtaining current structural parameters of the basic model; S403. Calculating the current structural parameters of the basic model through the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the basic model; S404. Determine whether the hemolytic characteristic data meets the preset requirements; If not, adjust the structural parameters based on the pump design theory and replace the current structural parameters of the base model with new structural parameters; Repeat S403-S405 until the hemolysis characteristic data meets the preset requirements; S406. If yes, manufacture an extracorporeal blood pump based on the structural parameters corresponding to the hemolytic characteristic data that meets the preset requirements.

16. A verification method for an extracorporeal blood pump according to claim 11, characterized in that: include: Combining computational fluid dynamics software and hemolysis calculation models, a blood pump hemolysis performance calculation platform was established; Providing an extracorporeal blood pump, and obtaining structural parameters of the extracorporeal blood pump; Calculating the structural parameters by using the blood pump hemolysis performance calculation platform to obtain hemolysis characteristic data of the extracorporeal blood pump; Verify whether the hemolysis characteristic data conforms to the preset data.

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