Drive unit and blood pump

Abstract

A drive device and a blood pump are disclosed. The housing assembly (100) of the drive device (10) has a through hole (101). The rotating shaft (200) has a shaft portion (210) and a ball head (220) fixedly connected to one end of the shaft portion (210). One end of the shaft portion (210) away from the ball head (220) is rotatably provided through the through hole (101). The first shaft sleeve (500) is attached to the housing assembly (100). The first shaft sleeve (500) has a receiving cavity (501) and a shaft hole (502). The receiving cavity (501) is adapted to the ball head. The shaft hole (502) communicates with the receiving cavity (501). The ball head is rotatably provided in the receiving cavity. The shaft portion is rotatably provided through the shaft hole. The aperture diameter of the shaft hole is smaller than the diameter of the ball head so as to limit the ball head within the receiving cavity.

Description

Technical Field

[0001] This application claims the priority of a Chinese patent application with application number 202210887639.0 filed with the China National Intellectual Property Administration on July 26, 2022, and all of its content is incorporated herein by reference.

[0002] This application relates to the technical field of medical devices, particularly to drive devices and blood pumps.

Background Art

[0003] The blood pump is designed to be inserted percutaneously into a patient's blood vessel, such as an artery or vein in the thigh or axilla, and can be inserted into the patient's heart to function as a left ventricular assist device or a right ventricular assist device.

[0004] The blood pump generally includes a drive device and an impeller. The impeller is connected to the rotating shaft of the drive device. To achieve stable rotation of the rotating shaft and ensure that the rotating shaft rotates with low friction, it is usually necessary to add a member for restricting the position of the rotating shaft. However, there are many current members for position restriction, which makes the structure of the drive device complex and assembly difficult.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Based on this, this application provides a drive device and a blood pump with low assembly difficulty.

Means for Solving the Problems

[0006] According to a first aspect, this application provides a housing assembly having a through hole, a rotating shaft having a shaft portion and a ball head fixedly connected to one end of the shaft portion, wherein one end of the shaft portion away from the ball head is rotatably penetrated and provided in the through hole, A drive device is provided, comprising a first shaft sleeve attached to the housing assembly and having a housing cavity and a shaft hole, wherein the housing cavity fits the ball head, the shaft hole communicates with the housing cavity, the ball head is rotatably mounted within the housing cavity, the shaft portion is rotatably mounted through the shaft hole, and the diameter of the shaft hole is smaller than the diameter of the ball head to restrict the ball head within the housing cavity.

[0007] According to a second aspect, the present application provides a blood pump including an impeller and a drive unit. The drive unit is A housing assembly having through holes, A rotating shaft having a shaft portion and a ball head fixedly connected to one end of the shaft portion, wherein the end of the shaft portion away from the ball head is provided to rotatably pass through the through hole, A first shaft sleeve, attached to the housing assembly, having a housing cavity and a shaft hole, wherein the housing cavity fits the ball head, the shaft hole communicates with the housing cavity, the ball head is rotatably mounted within the housing cavity, the shaft portion is rotatably mounted through the shaft hole, the diameter of the shaft hole is smaller than the diameter of the ball head so as to restrict the ball head within the housing cavity, and one end of the shaft portion away from the ball head is connected to the first shaft sleeve to the impeller.

[0008] Details of one or more embodiments of the present invention are described in the following drawings and description. Other features, purposes and advantages of the present invention will become apparent from the specification, drawings and claims. [Brief explanation of the drawing]

[0009] To provide a clearer explanation of the technical means in the embodiments of this application, the drawings that may be used to describe the embodiments or the prior art are briefly described below. As will be apparent, the drawings in the following description are only a few embodiments of this application, and those skilled in the art can obtain other drawings based on these without any creative effort. [Figure 1] This is a schematic diagram of the structure of a blood pump according to an embodiment of the present invention. [Figure 2] Figure 1 is an exploded view of the blood pump. [Figure 3] This is a cross-sectional view of the blood pump in Figure 1, with some of the catheters omitted. [Figure 4] Figure 3 is a schematic diagram of the rotor structure of the drive unit. [Figure 5] Figure 4 is a schematic diagram of the rotor flywheel structure. [Figure 6] Figure 3 is a schematic diagram showing the structure in which the stator and permeable member of the drive unit are assembled. [Figure 7] This is a cross-sectional view showing an assembled rotating shaft and first shaft sleeve according to one embodiment of the present invention. [Figure 8] This is a magnified view of part I in Figure 7. [Figure 9] This is a schematic assembly diagram of a rotating shaft, a first shaft sleeve, and a second shaft sleeve according to one embodiment of the present invention. [Figure 10] Figure 9 is a schematic diagram of the structure of the first fixing part of the first shaft sleeve. [Figure 11] This is a schematic assembly diagram of a rotating shaft, a first shaft sleeve, and a second shaft sleeve according to another embodiment of the present invention. [Figure 12] Figure 11 is a schematic diagram of the structure of the first fixing part of the first shaft sleeve. [Figure 13] Figure 11 is a schematic diagram of the structure of the second fixing part of the first shaft sleeve. [Modes for carrying out the invention]

[0010] Hereinafter, to more clearly understand the object, technical solution and advantages of the present application, the present application will be described in more detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only for the purpose of interpreting the present application and do not limit the present application.

[0011] In addition, when an element is referred to as being "fixed to" or "provided on" another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or indirectly connected to the other element.

[0012] Also, the terms "first" and "second" are for the purpose of explanation only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features shown. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present application, "plurality" means two or more unless otherwise specified.

[0013] In the field of interventional medicine, usually, one end close to the operator of the instrument is defined as the proximal end, and one end away from the operator is defined as the distal end.

[0014] The blood pump 1 and the drive device 10 in the embodiments of the present invention will be described.

[0015] As shown in FIGS. 1 to 3, the blood pump 1 includes a drive device 10 and an impeller 20. The drive device 10 is transmission-connected to the impeller 20, and the drive device 10 can drive the impeller 20 to rotate.

[0016] Specifically, the blood pump 1 further includes a cannula 30 fixedly connected to the distal end of the drive device 10. The impeller 20 is rotatably accommodated in the cannula 30. The cannula 30 has a blood inlet 31 and a blood outlet 32. When the impeller 20 rotates, blood flows into the cannula 30 from the blood inlet 31 and then flows out from the blood outlet 32. In one embodiment, the cannula 30 penetrates a heart valve, for example, the aortic valve, the blood inlet 31 is located inside the heart, and the blood outlet 32 and the drive device 10 are located in a blood vessel such as the aorta outside the heart.

[0017] Specifically, the blood pump 1 further includes a catheter 40 connected to the proximal end of the drive device 10. The catheter 40 accommodates various supply lines. For example, the supply lines include a conducting wire for electrically connecting the drive device 10 and a cleaning line for passing a cleaning liquid through the drive device 10 of the blood pump 1. Preferably, the cleaning liquid is physiological saline, heparin-containing physiological saline, glucose, or the like.

[0018] The drive device 10 includes a housing assembly 100, a rotating shaft 200, a rotor 300, a stator 400, and a first shaft sleeve 500.

[0019] The housing assembly 100 has its distal end fixedly connected to the cannula 30 and its proximal end fixedly connected to the catheter 40. One end of the housing assembly 100 has a through hole 101, and the through hole 101 is located at one end of the housing assembly 100 close to the cannula 30. The housing assembly 100 further has a cavity 102. The cavity 102 communicates with the through hole 101. The cleaning liquid in the cleaning line can flow into the cavity 102 and flow out of the housing assembly 100 through the through hole 101.

[0020] Specifically, the housing assembly 100 includes an external housing 110 and a second shaft sleeve 120.

[0021] The external housing 110 is a cylindrical housing that is generally open at both ends. The distal end of the external housing 110 is fixedly connected to the cannula 30, and the proximal end is fixedly connected to the catheter 40. The external housing 110 has the cavity 102. In some embodiments, the external housing 110 is formed by joining two substantially symmetrical half-housings so that a rotor 300, a stator 400, etc., can be mounted in the cavity 102 of the external housing 110.

[0022] The second axial sleeve 120 is fixedly connected to the outer housing 110, and the through hole 101 is formed in the second axial sleeve 120. The second axial sleeve 120 is provided at the opening at one end of the outer housing 110 that is close to the cannula 30.

[0023] The rotating shaft 200 is rotatably mounted to the housing assembly 100. The rotating shaft 200 is fixedly connected to the impeller 20 and can drive the impeller 20 to rotate. The rotating shaft 200 has a shaft portion 210 and a ball head 220 fixedly connected to one end of the shaft portion 210, with the end of the shaft portion 210 away from the ball head 220 rotatably passing through the through hole 101. The end of the shaft portion 210 away from the ball head 220 is fixedly connected to the impeller 20.

[0024] The shaft portion 210 is elongated. The shaft portion 210 has a connecting end 211 for connecting to the impeller 20, i.e., the connecting end 211 is the end of the shaft portion 210 away from the ball head 220. Part of the shaft portion 210 is located inside the outer housing 110, and part of it is located outside the outer housing 110 or inside the cannula 30. The connecting end 211 extends outside the outer housing 110 and is fixedly connected to the impeller 20. In the illustrated embodiment, the shaft portion 210 extends generally along the axial direction of the outer housing 110, or the direction of extension of the axis of the shaft portion 210 and the axial direction of the outer housing 110 generally coincide.

[0025] The ball head 220 is substantially spherical. The ball head 220 is fixedly connected to one end of the shaft portion 210, away from the connecting end 211. Specifically, the axis of the shaft portion 210 passes through the spherical center of the ball head 220. In the illustrated embodiment, the diameter of the ball head 220 is larger than the diameter of the shaft portion 210.

[0026] In some embodiments, the shaft portion 210 and the ball head 220 are made of ceramic material. Compared to metal materials, ceramics have high processing accuracy, high biocompatibility and mechanical strength, and good wear resistance and corrosion resistance. In some embodiments, the shaft portion 210 and the ball head 220 are integrally molded structures, and in some embodiments, the shaft portion 210 and the ball head 220 may be integrally and fixedly connected by assembly, welding, or adhesive. In some embodiments, the ball head 220 has a ball body and a diamond coating provided on the surface of the ball body, which smooths the surface of the ball head 220 and provides high wear resistance. In this case, the material of the ball body may be a material with a certain rigidity, such as metal or ceramics, and the material of the ball body may be the same as the material of the shaft portion 210.

[0027] As shown in Figures 3 and 4, the rotor 300 is fixedly connected to the shaft 210. Specifically, the rotor 300 includes a flywheel 310 and magnets 320, the flywheel 310 being fixedly connected to the shaft 210 and the magnets 320 being fixedly connected to the flywheel 310. In some embodiments, the magnets 320 are annular Halbach array magnets. In the illustrated embodiment, the rotor 300 is located within the cavity 102, between the through hole 101 and the first shaft sleeve 500, i.e., between the second shaft sleeve 120 and the first shaft sleeve 500. The rotor 300 is rotatable relative to the housing assembly 100 and can be rotated by driving the rotating shaft 200.

[0028] As shown in Figure 5, the flywheel 310 includes a disc-shaped portion 311, an internal tube 312, and an external tube 313. Both the internal tube 312 and the external tube 313 have a cylindrical structure, while the disc-shaped portion 311 has an annular disc structure. One end of both the internal tube 312 and the external tube 313 is fixedly connected to the disc-shaped portion 311. The internal tube 312 and the external tube 313 are located on the same side of the disc-shaped portion 311 and are provided coaxially. The inner diameter of the external tube 313 is larger than the outer diameter of the internal tube 312. At least a portion of the internal tube 312 is housed in the external tube 313, and an annular cavity 314 for housing a magnet 320 is formed between the external tube 313 and the internal tube 312. The shape of the annular cavity 314 is matched to the shape of the magnet 320 in order to facilitate the mounting and positioning of the magnet 320. In this way, the flywheel 310 can act as a position limiting force on the magnet 320, which not only facilitates the installation of the magnet 320 but also makes the coupling between the magnet 320 and the flywheel 310 more stable.

[0029] The flywheel 310 is not limited to the above structure. In some embodiments, the flywheel 310 does not have an external tube 313. In some embodiments, the flywheel 310 does not have an external tube 313 or an internal tube 312. In this case, the shaft portion 210 is fixedly provided penetrating the center of the disc-shaped portion 311. By providing an internal tube 312 to a flywheel 310 having only a disc-shaped portion 311, the flywheel 310 and the shaft portion 210 can be connected more stably. The shaft portion 210 may be fixedly connected to the disc-shaped portion 311 by various methods such as welding or bonding. The shaft portion 210 may be fixedly connected by holding it in a position-restricting structure so that it remains stationary relative to the disc-shaped portion 311. The shaft portion 210 may be fixedly connected to the flywheel 310 by rotating it synchronously with the internal tube 312, provided that there is a flat surface on the contact surface with the internal tube 312. In some embodiments, the flywheel 310 may be omitted, in which case the magnet 320 may be directly fixed to the shaft portion 210.

[0030] As shown in Figures 3 and 6, the stator 400 and rotor 300 are mounted along the axis of the shaft portion 210, and the stator 400 is located between the through hole 101 and the first shaft sleeve 500, that is, between the first shaft sleeve 500 and the second shaft sleeve 120. The stator 400 can drive the rotor 300 to rotate. Specifically, the stator 400 can generate a rotating magnetic field that drives the magnet 320 to rotate. By mounting the rotor 300 and stator 400 along the axis of the shaft portion 210, the overall diameter of the drive unit 10 can be reduced. In the illustrated embodiment, the stator 400 is fixedly attached to the housing assembly 100, and specifically, the stator 400 is located in the cavity 102, and the shaft portion 210 is rotatably mounted through the stator 400.

[0031] In the illustrated embodiment, the rotor 300 includes a first rotor unit 301 and a second rotor unit 302, which are provided along the axis of the shaft portion 210. Specifically, there are two flywheels 310, and accordingly, there are two magnets 320, with one flywheel 310 and one magnet 320 jointly forming the first rotor unit 301, and the other flywheel 310 and the other magnet 320 jointly forming the second rotor unit 302. The first rotor unit 301 and the second rotor unit 302 are provided opposite each other. The stator 400 is located between the first rotor unit 301 and the second rotor unit 302. The stator 400 includes a first stator unit 401 and a second stator unit 402, which are provided along the axis of the shaft 210. The first stator unit 401 can drive and rotate the first rotor unit 301, and the second stator unit 402 can drive and rotate the second rotor unit 302. Specifically, the first stator unit 401 can generate a rotating magnetic field that drives and rotates the first rotor unit 301, and the second stator unit 402 can generate a rotating magnetic field that drives and rotates the second rotor unit 302. Both the first stator unit 401 and the second stator unit 402 are fixedly housed in the cavity 102 of the housing assembly 100. The shaft 210 is provided rotatably through the first stator unit 401 and the second stator unit 402. The first stator unit 401 and the second stator unit 402 are both located between the first rotor unit 301 and the second rotor unit 302. In the illustrated embodiment, the first rotor unit 301, the first stator unit 401, the second stator unit 402, and the second rotor unit 302 are arranged in order along the axial direction.

[0032] Specifically, both the first stator unit 401 and the second stator unit 402 include a magnetic core 410 and a coil 420, with the coil 420 being wound around the magnetic core 410. The magnetic core 410 has a substantially columnar structure; that is, the magnetic core 410 does not have a wide head (i.e., a pole piece). Compared to a magnetic core with a pole piece, the columnar magnetic core 410 reduces magnetic loss and increases the magnetic coupling density between the magnetic core 410 and the magnet 320, thereby increasing the torque of the stator 400 on the magnet 320 (under the same current conditions). Furthermore, the magnetic core 410 without a head can significantly reduce problems such as localized magnetic short circuits and motor power reduction due to contact between adjacent magnetic cores 410.

[0033] Specifically, the direction of extension of the magnetic core 410 coincides with the axial direction of the outer housing 110 or the axial direction of the shaft portion 210. The first stator unit 401 and the second stator unit 402 have multiple magnetic cores 410, and each of the multiple magnetic cores 410 of the first stator unit 401 and the second stator unit 402 is arranged to circle the axis of the shaft portion 210. One coil 420 is provided corresponding to each magnetic core 410.

[0034] Specifically, the drive unit 10 further includes a permeable member 600 fixedly connected to the housing assembly 100, and the magnetic core 410 of the first stator unit 401 and the magnetic core 410 of the second stator unit 402 are both fixedly connected to the permeable member 600. In some embodiments, the permeable member 600 engages with the inner wall of the outer housing 110. The shaft portion 210 is provided rotatably through the permeable member 600. The permeable member 600 plays a role in closing magnetic paths, promoting and increasing magnetic flux generation and improving coupling ability. Therefore, providing the permeable member 600 can increase magnetic flux by closing the magnetic paths between the first stator unit 401 and the first rotor unit 301, and between the second stator unit 402 and the second rotor unit 302. Furthermore, providing the permeable member 600 is advantageous in reducing the overall diameter of the drive unit 10. Furthermore, by permanently connecting both the magnetic core 410 of the first stator unit 401 and the magnetic core 410 of the second stator unit 402 to the permeable member 600, the permeable member 600 can be directly and permanently connected to the housing assembly 100, thereby enabling the positioning and mounting of the first stator unit 401 and the second stator unit 402, and reducing the difficulty of assembling the first stator unit 401 and the second stator unit 402. At the same time, the permeable member 600 provided in the above manner can also reduce the installation of positioning structures within the housing assembly 100, simplifying the structure of the housing assembly 100 and simplifying the overall assembly process of the drive unit 10.

[0035] Specifically, the permeable member 600 includes two permeable plates 610, which are stacked, one permeable plate 610 is fixedly connected to the magnetic core 410 of the first stator unit 401, and the other permeable plate 610 is fixedly connected to the magnetic core 410 of the second stator unit 402, and the shaft portion 210 is provided so as to rotatably penetrate the two permeable plates 610. Preferably, the two permeable plates 610 are separate before assembly, and by providing the permeable member 600 as two separate permeable plates 610 before assembly, when assembling the drive unit 10, first the magnetic core 410 of the first stator unit 401 is fixedly connected to one permeable plate 610, the magnetic core 410 of the second stator unit 402 is fixedly connected to the other permeable plate 610, and then the two permeable plates 610 can be stacked. In this way, it is made easier to assemble the first stator unit 401 and the second stator unit 402 into two permeable plates 610 each, and the assembly of the first stator unit 401 and the second stator unit 402 can be made easier.

[0036] Specifically, by fixing the two permeable plates 610 together, the first stator unit 401, the second stator unit 402, and the permeable member 600 are integrated and assembled within the housing assembly 100, making the assembly of the stator 400 easier. For example, the two permeable plates 610 may be connected by adhesive or welding. In other embodiments, the two permeable plates 610 are not fixedly connected but are in contact with each other.

[0037] Furthermore, the permeable member 600 is not limited to a configuration in which the two separate permeable plates 610 described above are combined; the permeable member 600 may also have a plate-like structure, that is, the permeable member 600 may be a single permeable plate 610, in which case the first stator unit 401 and the second stator unit 402 share a single permeable plate 610.

[0038] Specifically, the permeable plate 610 is made of silicon steel, and the magnetic core 410 is made of silicon steel.

[0039] The structure of the rotor 300 and stator 400 is not limited to the above structure. In some embodiments, the drive unit 10 includes a first rotor unit 301, a second rotor unit 302, and a stator 400, but the stator 400 has only one stator unit, which is located between the first rotor unit 301 and the second rotor unit 302, and which can drive and rotate the first rotor unit 301 and the second rotor unit 302 simultaneously, in which case the permeable member 600 is omitted. Alternatively, in some embodiments, the rotor 300 has only one rotor unit, and the stator 400 has only one stator unit, in which case the rotor unit is located between the stator unit and the first shaft sleeve 500, or the rotor unit is located between the stator unit and the second shaft sleeve 120. The number of stator units of the stator 400 and the number of rotor units of the rotor 300 can be adjusted as needed.

[0040] As shown in Figures 3 and 7, the first shaft sleeve 500 is attached to the housing assembly 100. Specifically, the first shaft sleeve 500 is housed in the cavity 102 of the housing assembly 100. The first shaft sleeve 500 is fixedly connected to the outer housing 110. The rotor 300, stator 400, and first shaft sleeve 500 are spaced apart in the axial direction of the outer housing 110. In the illustrated embodiment, the first shaft sleeve 500 is located on the side of the first rotor unit 301 away from the stator 400.

[0041] In some embodiments, a certain gap is provided between the first shaft sleeve 500 and the first rotor unit 301 to avoid contact and wear between the two. However, to avoid the rotating shaft 200 being too long and to improve the load-bearing conditions of the rotating shaft 200, the gap between the two does not need to be made too large.

[0042] The first shaft sleeve 500 has a housing cavity 501 and a shaft hole 502, the housing cavity 501 fits the ball head 220, the shaft hole 502 communicates with the housing cavity 501, the ball head 220 is rotatably mounted within the housing cavity 501, the shaft portion 210 is rotatably mounted through the shaft hole 502, and the diameter of the shaft hole 502 is smaller than the diameter of the ball head 220 so as to restrict the ball head 220 within the housing cavity 501. Specifically, the housing cavity 501 is substantially spherical, or the cavity wall of the housing cavity 501 defines a spherical structure.

[0043] Since one end of the shaft portion 210, away from the ball head 220, is rotatably inserted through the through hole 101 of the housing assembly 100, the wall of the through hole 101 limits the radial swing range of the end of the shaft portion 210 away from the ball head 220. Furthermore, the ball head 220, which is fixedly connected to one end of the shaft portion 210, is rotatably provided within a housing cavity 501 that fits the ball head 220. The diameter of the ball head 220 is larger than the diameter of the shaft hole 502, restricting the ball head 220 to the housing cavity 501. As a result, the first shaft sleeve 500 restricts the radial swing range of the end of the shaft portion 210 that is close to the ball head 220, and also restricts the range of movement of the ball head 220 along the axis of the shaft portion 210. In other words, it achieves axial position restriction and radial position restriction with respect to the rotating shaft 200. Moreover, there is no need to provide a separate thrust member, which simplifies the structure of the drive unit 10 and is advantageous in reducing the difficulty of assembling the drive unit 10 and the blood pump 1.

[0044] At the same time, the rotation shaft 200 and the first shaft sleeve 500 work together with the ball head 220 and the housing cavity 501 that fits the ball head 220 to achieve a radial oscillation range at one end of the rotation shaft 200 that is close to the ball head 220, and a range of movement along the axis of the shaft portion 210 of the rotation shaft 200. This is advantageous in reducing friction between the ball head 220 and the first shaft sleeve 500, and thus reduces wear on the rotation shaft 200.

[0045] Specifically, the fit between the housing cavity 501 and the ball head 220 means that the shape of the cavity wall of the housing cavity 501 and the shape of the ball head 220 are the same, and the diameter of the ball head 220 is slightly smaller than the diameter of the housing cavity 501, so that the ball head 220 can rotate within the housing cavity 501, the cavity wall of the housing cavity 501 supports the ball head 220 and can restrict the ball head 220 in all directions, and both the cavity wall of the housing cavity 501 and the surface of the ball head 220 are smooth arc surfaces, thus reducing wear on both.

[0046] As shown in Figures 7 and 8, the shaft hole 502 has a first opening 504 and a second opening 505, and the shaft portion 210 is provided penetrating the first opening 504 and the second opening 505, the first opening 504 communicating with the housing cavity 501, and the second opening 505 being away from the housing cavity 501. Specifically, chamfers are provided on at least one edge of the first opening 504 and the second opening 505 to prevent the shaft portion 210 or the ball head 220 from being scratched and worn by the angular opening of the shaft hole 502.

[0047] Specifically, the first axial sleeve 500 further has a cleaning fluid hole 503 through which cleaning fluid flows, and the cleaning fluid hole 503 is in fluid communication with the housing cavity 501, and the diameter of the cleaning fluid hole 503 is smaller than the diameter of the ball head portion 220 so that the ball head portion 220 is confined to the housing cavity 501. Specifically, the cleaning fluid hole 503 is in communication with the cleaning line in the catheter 40 and can be in fluid communication with the cleaning line, thereby allowing the cleaning fluid to flow into the housing cavity 501 through the cleaning fluid hole 503.

[0048] Specifically, the cleaning fluid hole 503 has a third opening 506, which communicates with the housing cavity 501. The central axis of the third opening 506 passes through the center of the housing cavity 501, or through the center of the sphere on which the housing cavity 501 is located, and the central axis of the third opening 506 coincides with the central axis of the shaft hole 502. In this way, the cleaning fluid can flow well between the cavity wall of the housing cavity 501 and the ball head 220, acting as a lubricant to reduce the coefficient of friction between the ball head 220 and the cavity wall of the housing cavity 501, reducing wear between the ball head 220 and the first shaft sleeve 500. In addition, the cleaning fluid flowing into the housing cavity 501 from the cleaning fluid hole 503 can also act as buoyancy support for the ball head 220. The opening of the cleaning fluid hole 503 away from the third opening 506 communicates with the cleaning line in the catheter 40. More specifically, the central axis of the cleaning fluid hole 503 coincides with the central axis of the housing cavity 501, causing the cleaning fluid hole 503 to become a straight hole, thereby reducing the energy consumption of the cleaning fluid in the cleaning fluid hole 503.

[0049] In some embodiments, the diameter of the ball head 220 is defined as D1, and the diameter of one end of the shaft portion 210 adjacent to the ball head 220 is defined as D2. In one embodiment, the diameter D1 of the ball head 220 is at least twice the diameter D2 of the one end of the shaft portion 210 adjacent to the ball head 220, i.e., D1 ≥ 2D2. This makes the ball head 220 sufficiently large, i.e., by making the diameter of the ball head 220 sufficiently large, when the ball head 220 contacts the cavity wall of the housing cavity 501, the ball head 220 and the cavity wall of the housing cavity 501 have a large contact area, reducing wear on the ball head 220 and the cavity wall of the housing cavity 501. Specifically, in order to avoid the overall diameter of the blood pump 1 being too large, it is not necessary to make the diameter D1 of the ball head 220 too large.

[0050] In one embodiment, the diameter of the housing cavity 501 is defined as D3, and the ratio of the diameter D3 of the housing cavity 501 to the diameter D1 of the ball head 220 is 1.005 to 1.015, that is, D3:D1 is 1.005 to 1.015. By controlling the diameter D3 of the housing cavity 501 and the diameter D1 of the ball head 220 to the above ratio, the ball head 220 can have a certain amount of movement space within the housing cavity 501, ensuring that there is sufficient space to fill the housing cavity 501 with cleaning fluid, which not only ensures the smooth flow of cleaning fluid but also limits the axial and radial movement of the rotating shaft 200 to a reasonable range, ensuring stable rotation of the rotating shaft 200, and at the same time reducing wear between the ball head 220 and the cavity wall of the housing cavity 501. If the difference between the diameter of the ball head 220 and the diameter of the housing cavity 501 is too small, it will cause poor flow of the cleaning fluid and the buoyancy support effect of the cleaning fluid on the ball head 220 will be low. On the other hand, if the difference between the diameter of the ball head 220 and the cavity wall of the housing cavity 501 is too large, the contact surface between the ball head 220 and the cavity wall of the housing cavity 501 will be too small, increasing wear between the ball head 220 and the cavity wall of the housing cavity 501, and the movement of the ball head 220 within the housing cavity 501 will be large, making the operation of the drive unit 10 unstable.

[0051] In one embodiment, the diameter of the shaft hole 502 is defined as D4, and the ratio of the diameter D4 of the shaft hole 502 to the diameter D2 of one end of the shaft portion 210 adjacent to the ball head 220 is 1.15 to 1.35, that is, D4:D2 is 1.15 to 1.35. When the first shaft sleeve 500 and the hole wall of the through hole 101 restrict the position of the shaft portion 210 due to mounting or machining accuracy, it is difficult to guarantee that the axis of the shaft portion 210 and the axial direction of the outer housing 110 overlap or are perfectly parallel. Therefore, in order to achieve fault tolerance of the shaft portion 210, it is necessary to secure a gap space between the shaft hole 502 and the shaft portion 210. If the difference between the diameter of the shaft hole 502 and the diameter of the shaft portion 210 is small, the shaft portion 210 will be pressed against or locked against the wall of the shaft hole 502 when it rotates, resulting in uneven rotation of the rotating shaft 200, and severe wear will occur at the point where the shaft portion 210 and the wall of the shaft hole 502 come into contact. At the same time, if the difference between the diameter of the shaft hole 502 and the diameter of the shaft portion 210 is small, the cleaning fluid will not be able to move from the containment cavity 501 to the cavity of the housing assembly 100. If the flow of cleaning fluid into the tee 102 is unfavorable, the flow of cleaning fluid is not smooth, and the difference between the diameter of the shaft hole 502 and the diameter of the shaft portion 210 is large, the oscillation of the shaft portion 210 will be too large, the contact area between the ball head 220 and the cavity wall of the housing cavity 501 will be small, and wear of the ball head 220 will be particularly severe if the ball head 220 comes into contact with the cavity wall of the housing cavity 501 that is close to the shaft hole 502.

[0052] In one embodiment, if we define d1 as the difference between the diameter D3 of the housing cavity 501 and the diameter D1 of the ball head 220, and d2 as the difference between the hole diameter D4 of the shaft hole 502 and the diameter D2 of a portion of the shaft portion 210 adjacent to the ball head 220, then d2 is greater than d1. In this way, fault tolerance space can be secured in the shaft portion 210.

[0053] In one embodiment, the diameter of the third opening 506 of the cleaning fluid hole 503 is defined as D5, and the diameter D5 of the third opening 506 of the cleaning fluid hole 503 is 1 / 9 to 1 / 3 of the diameter D1 of the ball head 220. If the diameter of the third opening 506 of the cleaning fluid hole 503 is too large, the contact surface between the ball head 220 and the cavity wall of the housing cavity 501 becomes smaller (the pressure received per unit area increases), increasing wear on the ball head 220 by the cavity wall of the housing cavity 501. On the other hand, if the diameter of the third opening 506 is too small, it affects the amount of cleaning fluid that flows from the cleaning fluid hole 503 into the housing cavity 501. The cleaning fluid that flows into the cleaning fluid hole 503 imparts an impact force to the ball head 220 and also flows between the ball head 220 and the cavity wall of the housing cavity 501, providing lubrication and reducing the coefficient of friction between the ball head 220 and the cavity wall of the housing cavity 501. Therefore, it is undesirable for the amount of cleaning fluid that flows into the housing cavity 501 to be too small.

[0054] Furthermore, a chamfer is provided on the edge of the third opening 506 of the cleaning fluid hole 503 to prevent the ball head 220 from being scratched or worn.

[0055] In some embodiments, the first shaft sleeve 500 includes a first fixing portion 510 and a second fixing portion 520. The first fixing portion 510 and the second fixing portion 520 jointly define a housing cavity 501 and house the ball head 220 within the housing cavity 501. The first fixing portion 510 and the second fixing portion 520 may be fixed together by adhesive, welding, locking or other means, and a physical fixed connection is not required between the first fixing portion 510 and the second fixing portion 520, and they may only be in contact. Furthermore, the first fixing portion 510 and the second fixing portion 520 may be positioned opposite each other, but with a gap between them.

[0056] In one embodiment, as shown in Figures 3, 9, and 10, one side of the first fixing portion 510 is recessed to form a communicating first semi-hole 511 and a first hemispherical groove 512, and one side of the second fixing portion 520 is recessed to form a communicating second semi-hole 521 and a second hemispherical groove 522. The recessed side of the first fixing portion 510 and the recessed side of the second fixing portion 520 are arranged facing each other, the first semi-hole 511 and the second semi-hole 521 jointly form the shaft hole 502, and the first hemispherical groove 512 and the second hemispherical groove 522 jointly form the housing cavity 501. In this way, the recessed side of the first fixing portion 510 and the recessed side of the second fixing portion 520 are arranged facing each other, making assembly convenient, allowing the ball head 220 to be enclosed from both the left and right sides, and eliminating the need to consider the characteristics of the shaft portion 210. For example, if the shaft portion 210 has portions of different diameters at the end adjacent to the ball head 220, the diameter of the shaft hole 502 does not necessarily need to be larger than the maximum diameter of the shaft portion 210 in order for the shaft portion 210 to fit into and pass through the shaft hole 502.

[0057] Specifically, the recessed side of the first fixing part 510 is further recessed to form the first semi-liquid tank 513, the recessed side of the second fixing part 520 is further recessed to form the second semi-liquid tank 523, and the first semi-liquid tank 513 and the second semi-liquid tank 523 jointly form the cleaning liquid hole 503.

[0058] In the embodiment shown in Figure 9, the first shaft sleeve 500 is divided into a first fixing part 510 and a second fixing part 520 along a plane passing through the axis of the shaft part 210, and the first fixing part 510 and the second fixing part 520 are distributed symmetrically with respect to the plane passing through the axis of the shaft part 210. In other embodiments, the first shaft sleeve 500 is divided into a first fixing part 510 and a second fixing part 520 along a plane that makes a certain angle with the axis of the shaft part 210, and the first fixing part 510 and the second fixing part 520 are not necessarily the same in size and shape.

[0059] In another embodiment, as shown in Figures 11 to 13, the first fixing part 510 has a first hemispherical groove 512 and an axial hole 502 communicating with the first hemispherical groove 512, and the second fixing part 520 has a second hemispherical groove 522, and the first hemispherical groove 512 and the second hemispherical groove 522 jointly form a housing cavity 501. In this configuration, the joint surfaces of the first fixing portion 510 and the second fixing portion 520 are arranged to surround the axis of the shaft portion 210, the upper surface of the cavity wall of the housing cavity 501 is the first hemispherical groove 512 of the first fixing portion 510, and the lower surface of the cavity wall of the housing cavity 501 is the second hemispherical groove 522 of the second fixing portion 520. Since the upper and lower surfaces of the cavity wall of the housing cavity 501 are each formed independently with no joint gaps and the semicircular shape is more perfect, the corresponding contact surfaces in the axial direction of the shaft portion 210 of the ball head 220 are all perfectly smooth semicircles, which is advantageous in reducing wear between the ball head 220 and the cavity wall of the housing cavity 501, and also reduces the requirements for the assembly process of the first fixing portion 510 and the second fixing portion 520.

[0060] In the embodiment shown in Figure 11, the first shaft sleeve 500 is divided into a first fixing portion 510 and a second fixing portion 520, which are provided above and below a plane substantially perpendicular to the axis of the shaft portion 210.

[0061] Furthermore, as shown in Figures 2 and 3, one end of the rotating shaft 200 is a ball head 220, which is rotatably supported by the first shaft sleeve 500, and the other end of the rotating shaft 200 is the end of the shaft portion 210 that is away from the ball head 220, which is rotatably supported by the second shaft sleeve 120. As a result, both ends of the rotating shaft 200 are supported, the load-bearing force is stabilized, and the operation of the rotating shaft 200 and the rotor 300 is stabilized.

[0062] Specifically, at least one of the first shaft sleeve 500 and the second shaft sleeve 120 is made of a ceramic material. Compared to metal materials, ceramics have high processing accuracy, biocompatibility, high mechanical strength, and good wear resistance and corrosion resistance. In some embodiments, at least one of the first shaft sleeve 500 and the second shaft sleeve 120 has a shaft sleeve body and a diamond coating provided on the surface of the shaft sleeve body, which smooths the surfaces of the first shaft sleeve 500 and the second shaft sleeve 120 and improves wear resistance. In this case, the material of the shaft sleeve body may be a material with a certain rigidity, such as metal or ceramics.

[0063] Specifically, as shown in Figure 8, the roughness of at least one of the following surfaces is 0.1 micrometers or less: the hole wall of the through hole 101, the surface of the shaft portion 210, the surface of the ball head 220, the cavity wall of the housing cavity 501, and the hole wall of the shaft hole 502. This effectively reduces the frictional force between the shaft portion 210 and the hole wall of the through hole 101, the frictional force between the shaft portion 210 and the hole wall of the shaft hole 502, and the frictional force between the ball head 220 and the cavity wall of the housing cavity 501.

[0064] The above embodiments are merely for illustrating the technical solutions of the present invention and are not limiting. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art will understand that the technical solutions described in each of the above embodiments can be modified or some of their technical features can be replaced with equivalents. These modifications and replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of each embodiment of the present invention, and should all be included within the scope of protection of the present invention. [Explanation of symbols]

[0065] 1 blood pump, 10 drive unit, 20 impeller, 30 cannula, 31 blood inlet, 32 blood outlet, 40 catheter; 100 Housing assembly, 101 Through hole, 102 Cavity, 110 Outer housing, 120 Second axis sleeve; 200 Rotating shaft, 210 Shaft section, 211 Connecting end, 220 Ball head; 300 Rotor, 301 First rotor unit, 302 Second rotor unit, 310 Flywheel, 311 Disc-shaped section, 312 Internal tube, 313 External tube, 314 Annular cavity, 320 Magnet; 400 stator, 401 first stator unit, 402 second stator unit, 410 magnetic core, 420 coil; 500 First shaft sleeve, 501 Housing cavity, 502 Shaft hole, 503 Cleaning fluid hole, 504 First opening, 505 Second opening, 506 Third opening, 510 First fixing part, 511 First semi-hole, 512 First hemispherical groove, 513 First semi-liquid groove, 520 Second fixing part, 521 Second semi-hole, 522 Second hemispherical groove, 523 Second semi-liquid tank; 600 Permeable member, 610 Permeable plate.

Claims

1. A housing assembly having through holes, A rotating shaft having a shaft portion and a ball head fixedly connected to one end of the shaft portion, wherein the end of the shaft portion away from the ball head is provided to rotatably pass through the through hole, A drive device comprising a first shaft sleeve attached to the housing assembly, having a housing cavity, a shaft hole, and a cleaning fluid hole through which a cleaning fluid flows, wherein the housing cavity fits the ball head, the shaft hole communicates with the housing cavity, the cleaning fluid hole is in fluid communication with the housing cavity, the ball head is rotatably mounted within the housing cavity, the shaft portion is rotatably mounted through the shaft hole, the diameter of the shaft hole is smaller than the diameter of the ball head so as to restrict the ball head to the housing cavity, and the diameter of the cleaning fluid hole is smaller than the diameter of the ball head.

2. The diameter of the ball head is twice the diameter of the end of the shaft closest to the ball head. The drive device according to claim 1, characterized in that it is as described above.

3. The drive device according to claim 1, characterized in that the housing cavity is spherical, and the ratio of the diameter of the housing cavity to the diameter of the ball head is 1.005 to 1.

015.

4. The drive device according to claim 1, wherein the housing cavity is spherical, and the difference between the diameter of the housing cavity and the diameter of the ball head is defined as d1, and the difference between the diameter of the shaft hole and the diameter of one end of the shaft adjacent to the ball head is defined as d2, wherein d2 is greater than d1.

5. The drive device according to claim 1, characterized in that the ratio of the diameter of the shaft hole to the diameter of one end of the shaft portion adjacent to the ball head is 1.15 to 1.

35.

6. The first shaft sleeve includes a first fixing portion and a second fixing portion, One side of the first fixing portion is recessed to form a communicating first semi-hole and a first hemispherical groove, one side of the second fixing portion is recessed to form a communicating second semi-hole and a second hemispherical groove, the recessed side of the first fixing portion and the recessed side of the second fixing portion are provided opposite each other, the first semi-hole and the second semi-hole jointly form the shaft hole, and the first hemispherical groove and the second hemispherical groove jointly form the housing cavity, Alternatively, the drive device according to claim 1, characterized in that the first fixing portion has a first hemispherical groove and the shaft hole communicating with the first hemispherical groove, and the second fixing portion has a second hemispherical groove, and the first hemispherical groove and the second hemispherical groove jointly form the housing cavity.

7. The drive device according to claim 1, characterized in that the central axis of the cleaning fluid hole coincides with the central axis of the housing cavity.

8. A housing assembly having a through hole, A rotating shaft having a shaft portion and a ball head fixedly connected to one end of the shaft portion, wherein the end of the shaft portion away from the ball head is provided to rotatably pass through the through hole, A drive device comprising a first shaft sleeve attached to the housing assembly, having a housing cavity, a shaft hole, and a cleaning fluid hole through which a cleaning fluid flows, wherein the housing cavity fits the ball head, the shaft hole communicates with the housing cavity, the cleaning fluid hole communicates with the housing cavity, the ball head is rotatably mounted within the housing cavity, the shaft portion is rotatably mounted through the shaft hole, the diameter of the shaft hole is smaller than the diameter of the ball head so as to restrict the ball head within the housing cavity, and the central axis of the cleaning fluid hole coincides with the central axis of the housing cavity.

9. The drive device according to claim 1, wherein the housing assembly includes an outer housing and a second shaft sleeve, the second shaft sleeve and the first shaft sleeve are both fixedly connected within the outer housing, and the through hole is formed in the second shaft sleeve.

10. The drive device according to claim 9, wherein one end of the rotating shaft is the ball head, the ball head is rotatably supported on the first shaft sleeve, and the other end of the rotating shaft is the end of the shaft portion away from the ball head, and is rotatably supported on the second shaft sleeve.

11. The drive device according to claim 1, wherein the shaft hole has a first opening and a second opening, the first opening communicates with the housing cavity, the second opening is separated from the housing cavity, at least one edge of the first opening and the second opening is chamfered, and the shaft portion is provided penetrating the first opening and the second opening.

12. The drive device according to claim 1, further comprising a rotor and a stator provided along the axis of the shaft, wherein the rotor and the stator are located between the first shaft sleeve and the through hole, the rotor is fixedly connected to the shaft, and the stator can drive the rotor to rotate.

13. The drive device according to claim 12, wherein the rotor includes a flywheel and a magnet, the flywheel is fixedly connected to the shaft, the magnet is fixedly connected to the flywheel, the stator is capable of generating a rotating magnetic field to drive and rotate the magnet, the flywheel includes a disc-shaped portion, an internal tube and an external tube, one end of the internal tube and the external tube is fixedly connected to the disc-shaped portion, the internal tube and the external tube are located on the same side of the disc-shaped portion and are provided coaxially, the inner diameter of the external tube is larger than the outer diameter of the internal tube, the internal tube is at least partially housed in the external tube, and an annular cavity for housing the magnet is formed between the external tube and the internal tube.

14. The rotor includes a first rotor unit and a second rotor unit provided along the axis of the shaft, the stator includes a first stator unit and a second stator unit provided along the axis of the shaft, both the first stator unit and the second stator unit are located between the first rotor unit and the second rotor unit, the first stator unit can drive the first rotor unit to rotate, the second stator unit can drive the second rotor unit to rotate, both the first stator unit and the second stator unit include a magnetic core. The drive device according to claim 12, further comprising a permeable member fixedly connected to the housing assembly, wherein the magnetic core of the first stator unit and the magnetic core of the second stator unit are both fixedly connected to the permeable member, and the shaft portion is provided so as to rotatably penetrate the first stator unit, the second stator unit and the permeable member.

15. A housing assembly having a through hole, A rotating shaft having a shaft portion and a ball head fixedly connected to one end of the shaft portion, wherein the end of the shaft portion away from the ball head is provided to rotatably pass through the through hole, A first shaft sleeve, attached to the housing assembly, having a housing cavity and a shaft hole, wherein the housing cavity fits the ball head, the shaft hole communicates with the housing cavity, the ball head is rotatably mounted within the housing cavity, the shaft portion is rotatably mounted through the shaft hole, and the diameter of the shaft hole is smaller than the diameter of the ball head to restrict the ball head to the housing cavity; A rotor and stator provided along the axis of the shaft, wherein the rotor and stator are located between the first shaft sleeve and the through hole, the rotor is fixedly connected to the shaft, the stator can drive the rotor to rotate, the rotor includes a first rotor unit and a second rotor unit provided along the axis of the shaft, the stator includes a first stator unit and a second stator unit provided along the axis of the shaft, both the first stator unit and the second stator unit are located between the first rotor unit and the second rotor unit, the first stator unit can drive the first rotor unit to rotate, the second stator unit can drive the second rotor unit to rotate, and both the first stator unit and the second stator unit include a magnetic core. A drive device characterized in that a permeable member fixedly connected to the housing assembly, wherein the magnetic core of the first stator unit and the magnetic core of the second stator unit are both fixedly connected to the permeable member, and the shaft portion includes a permeable member that is rotatably provided to penetrate the first stator unit, the second stator unit and the permeable member.

16. The drive device according to claim 1, characterized in that the cleaning fluid hole has a third opening, the third opening communicates with the housing cavity, the housing cavity is spherical, the central axis of the third opening passes through the center of the sphere in which the housing cavity is located, and the central axis of the third opening coincides with the central axis of the shaft hole.

17. The drive device according to claim 16, characterized in that the diameter of the third opening of the cleaning fluid hole is 1 / 9 to 1 / 3 of the diameter of the ball head.

18. The drive device according to claim 1, characterized in that the central axis of the shaft portion passes through the center of the ball head.

19. The drive device according to claim 1, characterized in that the ball head has a ball body and a diamond coating provided on the surface of the ball body, or the material of the ball head is metal or ceramic.

20. A blood pump comprising an impeller and a drive device according to any one of claims 1 to 19, A blood pump characterized in that one end of the shaft portion, away from the ball head, is connected to the impeller.

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