WO2023202165A1 - 血泵及心脏辅助装置 - Google Patents

血泵及心脏辅助装置 Download PDF

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Publication number
WO2023202165A1
WO2023202165A1 PCT/CN2023/070632 CN2023070632W WO2023202165A1 WO 2023202165 A1 WO2023202165 A1 WO 2023202165A1 CN 2023070632 W CN2023070632 W CN 2023070632W WO 2023202165 A1 WO2023202165 A1 WO 2023202165A1
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WO
WIPO (PCT)
Prior art keywords
blood pump
rotating shaft
impeller
shell
sliding bearing
Prior art date
Application number
PCT/CN2023/070632
Other languages
English (en)
French (fr)
Inventor
李慧勇
刘旭东
易博
罗七一
常兆华
Original Assignee
上海微创心力医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202210427662.1A external-priority patent/CN116966413A/zh
Priority claimed from CN202220941380.9U external-priority patent/CN217286897U/zh
Application filed by 上海微创心力医疗科技有限公司 filed Critical 上海微创心力医疗科技有限公司
Publication of WO2023202165A1 publication Critical patent/WO2023202165A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices

Definitions

  • This application relates to the technical field of medical devices, and in particular to a blood pump and a heart assist device.
  • PCI Percutaneous coronary intervention
  • a cardiac assist device is implanted in the human heart to assist the heart in pumping blood.
  • the main working principle is to pump the blood through the aorta, across the aortic valve, and the inlet window. It is placed in the left ventricle, and the outlet window is placed in the aorta.
  • the motor drives the impeller to rotate, pumping blood in the left ventricle to the aorta, reducing the heart's workload and maintaining blood circulation.
  • a groove is provided on the outer wall of the sliding bearing, and the groove is used to fill an adhesive material to fix the sliding bearing to the inner wall of the housing.
  • the groove is an annular groove or an arc groove provided around the center line of the sliding bearing, and the cross section of the groove is semicircular, square or zigzag;
  • the grooves include one or more, and a plurality of the grooves are arranged at intervals along the axial direction of the sliding bearing.
  • the gap is 2 ⁇ m to 5 ⁇ m.
  • the rolling bearing includes an inner ring, an outer ring and balls disposed between the outer ring and the inner ring.
  • the outer ring and the inner ring are rotationally connected through the balls.
  • the inner ring and the The end of the rotating shaft away from the impeller is tightly fitted.
  • the casing includes a first shell and a second shell connected, the first shell is provided with an outlet window penetrating its wall, the impeller is located in the first shell, and the sliding Bearings and rolling bearings are located in the second shell, and the rotating shaft extends from the second shell into the first shell and is connected to the impeller.
  • the blood pump further includes a stator assembly and a rotor assembly.
  • the rotor assembly is fixed on the rotating shaft.
  • the stator assembly has a stator core and a stator coil.
  • the stator core is fixed on the rotating shaft.
  • the stator coil is located between the rotor assembly and the stator core.
  • the blood pump further includes a stator assembly and a rotor assembly.
  • the rotor assembly is fixed on the rotating shaft.
  • the stator assembly has a stator core and a stator coil.
  • the second shell includes a stator core and a stator coil.
  • the proximal shell and the distal shell are respectively connected to both ends of the stator core.
  • the stator coil is located between the rotor assembly and the stator core. Between the stator cores, the distal housing is connected to the first housing.
  • the rolling bearing is made of ceramic material, and the wall surface of the shaft hole of the rolling bearing has a wear-resistant coating.
  • a cardiac assist device includes a perfusion mechanism and the blood pump.
  • the perfusion mechanism is connected to an end of the blood pump away from the impeller.
  • Figure 1 is a schematic cross-sectional view of a blood pump according to an embodiment of the present application
  • Figure 2 is a schematic diagram of a sliding bearing of a blood pump according to an embodiment of the present application
  • Figure 3 is a schematic cross-sectional view of the cooperation between the sliding bearing and the rotating shaft shown in Figure 2;
  • Figure 4 is a schematic diagram of a sliding bearing of a blood pump according to another embodiment of the present application.
  • Figure 5 is a schematic cross-sectional view of the sliding bearing and the housing shown in Figure 4 of the present application;
  • Figure 6 is a schematic diagram of a sliding bearing of a blood pump according to another embodiment of the present application.
  • Figure 7 is a schematic diagram of a sliding bearing of a blood pump according to yet another embodiment of the present application.
  • Figure 8 is a schematic diagram of a sliding bearing of a blood pump according to another embodiment of the present application.
  • Shell 110. First shell; 101. Exit window; 120. Second shell; 122. Proximal shell; 124. Distal shell; 20. Driving structure; 210. Rotating shaft; 220. Sliding bearing; 222 , shaft hole; 224, gap; 226, groove; 230, rolling bearing; 240, stator assembly; 242, stator core; 244, stator coil; 250, rotor assembly; 30, impeller; 40, bonding material; 1. Hollow arrow; 2. Solid arrow.
  • connection In this application, unless otherwise clearly stated and limited, the terms “installation”, “connection”, “connection”, “fixing” and other terms should be understood in a broad sense. For example, it can be a fixed connection or a detachable connection. , or integrated; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two elements or an interactive relationship between two elements, unless otherwise specified limitations. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.
  • a first feature being “on” or “below” a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediary. touch.
  • the terms “above”, “above” and “above” the first feature is above the second feature may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is higher in level than the second feature.
  • "Below”, “below” and “beneath” the first feature to the second feature may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature has a smaller horizontal height than the second feature.
  • An embodiment of the present application provides a cardiac assist device, which includes a perfusion mechanism and a blood pump.
  • the perfusion mechanism is connected to an end of the blood pump away from the impeller 30 .
  • the perfusion mechanism is used to continuously input perfusion fluid into the blood pump.
  • a blood pump includes a housing 10 and a driving structure 20 and an impeller 30 disposed in the housing 10 .
  • the driving structure 20 includes a rotating shaft 210 , a sliding bearing 220 and a rolling bearing 230 .
  • One end of the rotating shaft 210 is connected to the impeller 30 .
  • the sliding bearing 220 and the rolling bearing 230 are both fixedly connected to the housing 10.
  • the sliding bearing 220 is provided with a shaft hole 222, and the sliding bearing 220 is sleeved on the housing through the shaft hole 222.
  • One end of the rotating shaft 210 is close to the impeller 30 , and a gap 224 is formed between the shaft hole 222 and the rotating shaft 210 .
  • the rolling bearing 230 is sleeved on an end of the rotating shaft 210 away from the impeller 30 .
  • the blood pump is placed in the body, and the rotation of the rotating shaft 210 drives the impeller 30 to rotate, pumping the blood in the left ventricle to the aorta, reducing the heart workload and maintaining blood circulation; at the same time, the perfusion mechanism continues to input into the blood pump
  • the perfusion liquid flows to the impeller 30 through the gap 224 between the shaft hole 222 of the sliding bearing 220 and the rotating shaft 210 to prevent the blood pumped by the impeller 30 from entering the driving structure 20 through the gap 224 .
  • an outlet window 101 penetrating the wall is provided at one end of the housing 10 close to the impeller 30 .
  • Impeller 30 pumps blood from the left ventricle from the outlet window 101 to the aorta.
  • the hollow arrow 1 in Figure 1 is the flow direction of blood in the blood pump
  • the solid arrow 2 is the flow direction of the perfusate in the blood pump.
  • the blood pump and heart assist device of this embodiment are provided with a sliding bearing 220 at the end of the rotating shaft 210 close to the impeller 30 and a rolling bearing 230 at the end of the rotating shaft 210 away from the impeller 30.
  • the sliding bearing 220 and the rolling bearing 230 are It has a radial support function and can achieve radial stable rotation of the rotating shaft 210; and a gap 224 is formed between the shaft hole 222 of the sliding bearing 220 and the rotating shaft 210. Under the condition of liquid lubrication in the gap 224, the sliding bearing 220 and the rotating shaft 210 are The lubricating liquid is separated without direct contact.
  • the rotating shaft 210 When the rotating shaft 210 radially deflects, it will receive the radial restoring force provided by the squeezed liquid to ensure that the rotating shaft 210 rotates in the center.
  • the existence of the gap 224 and the automatic movement of the sliding film of the sliding bearing 220 The nature of the alignment avoids the problems of difficulty in assembling the bearing and the rotating shaft 210 and difficulty in coaxial alignment of the double rolling bearing 230 existing in the traditional double rolling bearing 230 solution.
  • the gap 224 existing between the sliding bearing 220 and the rotating shaft 210 can lower the rotating shaft 210. Difficulty of assembly with bearings.
  • proximal end and distal end refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a physician using the medical device, although “proximal end” and “distal end” are not Restrictive, but “proximal” generally refers to the end of the medical device that is closest to the physician during normal operation, while “distal” generally refers to the end that first enters the patient's body.
  • the blood pump in this embodiment uses a sliding bearing 220 at one end close to the impeller 30. Since the sliding bearing 220 has a smaller axial gap 224 than the rolling bearing 230, the perfusion pressure of the perfusion fluid there can be increased and the blood flow into the driving structure 20 can be reduced. Internal risk of thrombosis.
  • the sliding bearing 220 of the blood pump in this embodiment is an independent part, which is processed and formed separately, and is assembled between the rotating shaft 210 and the casing 10 of the blood pump.
  • the processing is simple, and it is easy to control the size and clearance 224 of the sliding bearing 220; the sliding bearing 220 relies on
  • the gap 224 between the rotating shafts 210 forms a hydraulic sliding film, and the existence of the gap 224 reduces the difficulty of assembling the rotating shaft 210 and the bearing.
  • the gap 224 is 2 ⁇ m to 5 ⁇ m.
  • the sliding bearing 220 proposed in this application is used for the special purpose of an artificial heart blood pump. In order to prevent blood cells from entering the inner cavity of the bearing and driving structure 20, the gap 224 between the sliding bearing 220 and the rotating shaft 210 is limited.
  • the gap 224 formed by the sliding bearing 220 and the rotating shaft 210 may be a uniform gap 224 or a non-uniform gap 224 along the axial direction.
  • the space between the sliding bearing 220 and the rotating shaft 210 is The radial length of the gap 224 is limited to 2 ⁇ m to 5 ⁇ m.
  • the gap 224 is 3 ⁇ m, 4 ⁇ m, etc.
  • the rolling bearing 230 is made of ceramic material, and the wall surface of the shaft hole 222 of the rolling bearing 230 has a wear-resistant coating.
  • the sliding bearing 220 can be made of ceramic or other high wear-resistant materials.
  • the inner surface of the sliding bearing 220 can be further treated with a wear-resistant coating to form a wear-resistant coating, such as DLC coating.
  • the sliding bearing 220 uses highly wear-resistant materials such as ceramics to improve the wear resistance of the sliding bearing 220, reduce the generation of particles, and ensure the safety, reliability and stability of the high-speed operation of the rotating shaft 210.
  • the rolling bearing 230 includes an inner ring, an outer ring and balls disposed between the outer ring and the inner ring.
  • the outer ring and the inner ring are rotationally connected through the balls, and the inner ring
  • the ring is tightly matched with the end of the rotating shaft 210 away from the impeller 30 .
  • the inner ring of the rolling bearing 230 rotates with the proximal end of the rotating shaft 210, and the outer ring of the rolling bearing 230 does not rotate, providing radial support to the proximal end of the rotating shaft 210 to make it rotate smoothly; the distal end of the rotating shaft 210 and There is a gap 224 between the sliding bearings 220.
  • the sliding bearing 220 does not rotate with the rotating shaft 210. Since the synovial membrane can be formed by the perfusion liquid at the gap 224, when the distal end of the rotating shaft 210 is radially deflected, it can be affected by the radial force provided by the squeezed liquid. The restoring force ensures the central rotation of the rotating shaft 210 and provides radial support to the far end of the rotating shaft 210 to make it rotate smoothly.
  • the casing 10 includes a first casing 110 and a second casing 120 that are connected.
  • the first casing 110 is provided with an outlet window 101 penetrating its wall, and the impeller 30 is located on the first casing 110 . inside the shell 110.
  • the sliding bearing 220 and the rolling bearing 230 are located in the second shell 120 , and the rotating shaft 210 extends from the second shell 120 into the first shell 110 to be connected with the impeller.
  • the distal blood enters the first shell 110 under the action of the impeller 30 and is pumped out through the outlet window 101.
  • the perfusion liquid is poured into the second shell 120 and flows out from the outlet window 101.
  • the perfusion liquid has a certain perfusion pressure, which is greater than that at the impeller 30.
  • the pressure of the blood prevents the blood from the first shell 110 from entering the second shell 120 .
  • the flow of the perfusion fluid in the second shell 120 can take away the heat generated by the driving structure, ensuring the safety and reliability of the blood pump operation.
  • the perfusion fluid can be blood-harmless liquids such as physiological saline or glucose solution.
  • the blood pump further includes a stator assembly 240 and a rotor assembly 250, and the rotor assembly 250 is fixed on the rotating shaft 210.
  • the stator assembly 240 has a stator core 242 and a stator coil 244.
  • the stator core 242 is fixed on the second shell 120.
  • the stator coil 244 is located between the rotor assembly 250 and the stator core 242. between. That is, the second shell 120 is a component independent of the stator core 242 and is placed outside the stator core 212, the stator coil 244 and the driving mechanism.
  • the second housing 120 includes a proximal housing 122 , a distal housing 124 and the stator core 242 .
  • the proximal housing 122 and the distal housing 124 are connected to two ends of the stator core 242 respectively.
  • the stator coil 244 is located between the rotor assembly 250 and the stator core 242 , and the distal housing 124 is connected to the first housing 110 . That is, the stator core 242 serves as a part of the second shell 120, and together with the proximal shells 122 and the distal shell 124 at both ends, forms the second shell 120 placed outside the stator coil 244 and the driving mechanism.
  • Such an arrangement can reduce the volume of the blood pump, or increase the space inside the blood pump without increasing the volume of the blood pump, thereby optimizing the structure and performance of the blood pump.
  • an end of the stator coil 244 away from the impeller 30 is connected to an external controller through a cable.
  • the rotor assembly 250 and the stator assembly 240 can drive the rotating shaft 210 through the principles of the existing technology. Under the control of an external controller, the rotating shaft 210 and the impeller 30 connected thereto are driven to rotate at a high speed. The impeller 30 will enter the first assembly from the far end.
  • the blood in the shell 110 is pumped out through the outlet window 101 . It can be seen from the relationship between action force and reaction force that the rotating shaft 210 will receive an action force opposite to the blood flow direction.
  • the inner ring of the proximal rolling bearing 230 is tightly connected to the rotating shaft 210 through matching or glue bonding, and the axial load-bearing capacity of the rolling bearing 230 is used to achieve resistance to the blood flow reaction force and ensure the axial balance and stability of the rotating shaft 210.
  • One end of the housing 10 close to the impeller 30 is provided with an outlet window 101 penetrating the wall; multiple outlet windows 101 are provided around the circumference of the housing 10 . Further, the end of the housing 10 away from the impeller 30 is provided with a perfusion liquid inlet. The perfusion liquid enters the housing 10 through the perfusion liquid inlet, and flows along between the balls of the rolling bearing 230, between the stator 240 and the rotor 250, and between the sliding bearings. The flow flows out of the gap between 220 and the rotating shaft 210 to the outlet window 101 and out of the housing 10 .
  • a groove 226 is provided on the outer wall of the sliding bearing 220, and the groove 226 is used to fill the adhesive material 40 to fix the sliding bearing 220 to the location. the inner wall of the housing 10.
  • the adhesive material 40 is added to the groove 226 to push the sliding bearing 220 into the inner cavity of the housing 10 along the axial direction. When the adhesive material 40 solidifies, the sliding bearing 220 and the housing 10 are firmly bonded together.
  • the sliding bearing 220 has a groove 226 structure to facilitate the bonding and fixing of the sliding bearing 220 and the housing 10 .
  • the groove 226 is an annular groove or an arc groove provided around the center line of the sliding bearing 220 .
  • the fixing grooves 226 may be continuous at 360° along the circumferential direction, or may be intermittently distributed.
  • the groove 226 has a semicircular, square or zigzag cross section.
  • FIG. 6 shows a schematic diagram of the sliding bearing 220 with a square groove 226
  • FIG. 7 shows a schematic diagram of the sliding bearing 220 with a semicircular groove 226 .
  • the groove 226 includes one or more, and a plurality of the grooves 226 are spaced apart along the axial direction of the sliding bearing 220 .
  • FIG. 7 shows a schematic diagram of a plain bearing 220 with double semicircular grooves 226 .

Abstract

一种血泵及心脏辅助装置，血泵包括外壳（10）及设置于外壳（10）内的驱动结构（20）与叶轮（30），驱动结构（20）包括转轴（210）、滑动轴承（220）及滚动轴承（230），转轴（210）的一端与叶轮（30）连接，滑动轴承（220）及滚动轴承（230）均与外壳（10）固定连接，滑动轴承（220）设有轴孔（222），滑动轴承（220）通过轴孔（222）套设于转轴（210）靠近叶轮（30）的一端，轴孔（222）与转轴（210）之间形成有间隙（224），滚动轴承（230）套设于转轴（210）远离叶轮（30）的一端。

Description

血泵及心脏辅助装置
相关申请
本申请要求2022年04月22日申请的，申请号为2022104276621，名称为“血泵及心脏辅助装置”的中国专利申请的优先权，以及2022年04月22日申请的，申请号为2022209413809，名称为“血泵及心脏辅助装置”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及医疗器械技术领域，特别是涉及一种血泵及心脏辅助装置。
背景技术
经皮冠状动脉介入手术(PCI)是一种常用的治疗冠心病的有效方法。在PCI手术中，患者心脏往往处于不稳定的搏动状态，一般采用在人体心脏植入心脏辅助装置辅助心脏泵血，主要工作原理是将其血泵经主动脉，跨过主动脉瓣，入口窗置于左心室中，出口窗置于主动脉中，通过电机驱动叶轮旋转，将左心室里的血液泵到主动脉中，降低心脏工作负荷，维持血液循环。
传统血泵的电机转轴两端分别设置滚动轴承以将电机转轴支撑于电机外壳中，由于滚动轴承的内圈需要与电机转轴紧配，导致电机转轴两端的两个滚动轴承装配困难；而且由于电机外壳尺寸空间狭小，两个滚动轴承的同轴度难以保证，直接影响血泵的高速运行性能。
发明内容
基于此，有必要提供一种血泵及心脏辅助装置。
一种血泵，包括外壳及设置于所述外壳内的驱动结构与叶轮，所述驱动结构包括转轴、滑动轴承及滚动轴承，所述转轴的一端与所述叶轮连接，所述滑动轴承、所述滚动轴承均与所述外壳固定连接，所述滑动轴承设有轴孔，所述滑动轴承通过所述轴孔套设于所述转轴靠近所述叶轮的一端，所述轴孔与所述转轴之间形成有间隙，所述滚动轴承套设于所述转轴远离所述叶轮的一端。
在其中一实施例中，所述滑动轴承的外壁上设有凹槽，所述凹槽内用于填充粘接材料 以使所述滑动轴承固定于所述外壳的内壁。
在其中一实施例中，所述凹槽为绕所述滑动轴承的中心线设置的环形槽或者弧形槽，所述凹槽的截面呈半圆形、方形或者锯齿形；
在其中一个实施例中，所述凹槽包括1个或多个，多个所述凹槽沿所述滑动轴承的轴向间隔设置。
在其中一实施例中，所述间隙为2μm～5μm。
在其中一实施例中，所述滚动轴承包括内圈、外圈及设于外圈与内圈之间的滚珠，所述外圈与内圈通过所述滚珠转动连接，所述内圈与所述转轴远离所述叶轮的一端紧配。
在其中一实施例中，所述外壳包括相连接的第一壳与第二壳，所述第一壳开设有贯穿其壁面的出口窗，所述叶轮位于所述第一壳内，所述滑动轴承与滚动轴承位于所述第二壳内，所述转轴由所述第二壳伸入所述第一壳内与所述叶轮连接。
在其中一实施例中，所述的血泵还包括定子组件与转子组件，所述转子组件固设于所述转轴，所述定子组件具有定子铁芯与定子线圈，所述定子铁芯固设于所述第二壳内，所述定子线圈位于所述转子组件与所述定子铁芯之间。
在其中一实施例中，所述的血泵还包括定子组件与转子组件，所述转子组件固设于所述转轴，所述定子组件具有定子铁芯与定子线圈，所述第二壳包括近端壳体、远端壳体及所述定子铁芯，所述近端壳体与所述远端壳体分别与所述定子铁芯的两端相连，所述定子线圈位于所述转子组件与所述定子铁芯之间，所述远端壳体与所述第一壳连接。
在其中一实施例中，所述滚动轴承采用陶瓷材料制作，所述滚动轴承的轴孔的壁面具有耐磨涂层。
一种心脏辅助装置，包括灌注机构及所述的血泵，所述灌注机构与所述血泵远离所述叶轮的一端连接。
附图说明
为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。
图1为本申请一实施例的血泵的剖面示意图；
图2为本申请一实施例的血泵的滑动轴承的示意图；
图3为图2示出的滑动轴承与转轴配合的剖面示意图；
图4为本申请另一实施例的血泵的滑动轴承的示意图；
图5为本申请图4示出的滑动轴承与外壳配合的剖面示意图；
图6为本申请又一实施例的血泵的滑动轴承的示意图；
图7为本申请再一实施例的血泵的滑动轴承的示意图；
图8为本申请其它一实施例的血泵的滑动轴承的示意图。
附图标号说明：
10、外壳；110、第一壳；101、出口窗；120、第二壳；122、近端壳体；124、远端壳体；20、驱动结构；210、转轴；220、滑动轴承；222、轴孔；224、间隙；226、凹槽；230、滚动轴承；240、定子组件；242、定子铁芯；244、定子线圈；250、转子组件；30、叶轮；40、粘接材料；1、空心箭头；2、实心箭头。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
本申请一实施例提供一种心脏辅助装置，包括灌注机构及血泵，所述灌注机构与血泵远离叶轮30的一端连接。灌注机构用于持续地向血泵内输入灌注液。
参照图1，一实施例中，血泵包括外壳10及设置于所述外壳10内的驱动结构20与叶轮30。所述驱动结构20包括转轴210、滑动轴承220及滚动轴承230，所述转轴210的一端与所述叶轮30连接。参照图2、3，所述滑动轴承220及滚动轴承230均与所述外壳10固定连接，所述滑动轴承220设有轴孔222，所述滑动轴承220通过所述轴孔222套设于所述转轴210靠近所述叶轮30的一端，所述轴孔222与所述转轴210之间形成有间隙224。所述滚动轴承230套设于所述转轴210远离所述叶轮30的一端。
在PCI手术时，血泵置于体内，转轴210转动带动叶轮30旋转，将左心室里的血液泵到主动脉中，降低心脏工作负荷，维持血液循环；同时灌注机构持续地向血泵内输入灌注液，灌注液经滑动轴承220的轴孔222与转轴210之间的间隙224流向叶轮30，防止叶轮30泵入的血液由此间隙224进入驱动结构20内部。进一步地，所述外壳10靠近叶轮30的一端的设有贯穿壁面的出口窗101。叶轮30将左心室的血液从出口窗101泵出至主动脉。其中，图1中空心箭头1为血液在血泵内的流动方向，实心箭头2为灌注液在血泵内的流动方向。
本实施例的血泵及心脏辅助装置，通过在转轴210靠近叶轮30的一端设置滑动轴承220，在转轴210远离叶轮30的一端设置滚动轴承230，通过混合轴承支撑方案，其中滑动轴承220和滚动轴承230具有径向支撑作用，可实现转轴210径向稳定旋转；而且滑动轴承220的轴孔222与转轴210之间形成有间隙224，在该间隙224存在液体润滑条件下，滑动轴承220与转轴210被润滑液分开而不发生直接接触，当转轴210发生径向偏移时会受到被挤压液体提供的径向回复力，保证转轴210居中旋转，该间隙224的存在以及滑动 轴承220滑膜的自对中的性质，避免传统双滚动轴承230方案存在的轴承与转轴210装配困难以及双滚动轴承230同轴对中困难的问题。通过远端径向滑动轴承220和近端滚动轴承230的混合支撑技术在保证具有对转轴210的轴向和径向支撑作用的同时，滑动轴承220与转轴210之间存在的间隙224可以降低转轴210与轴承的装配难度。其中，“近端”和“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”和“远端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
相比传统的双滚动轴承230方案存在血液进入血泵内部风险，因为滚动轴承230的滚珠之间间隙224较大，存在血液进入滚动轴承230，并被轴承打碎形成血栓的风险，即使采用液体持续的从血泵近端灌注到血泵远端，但由于滚动轴承230滚珠间隙224较大，灌注液在较大间隙224处无法维持较高灌注压力，很难起到抵抗血液进入血泵的作用。本实施例的血泵靠近叶轮30的一端采用滑动轴承220，由于滑动轴承220相较滚动轴承230具有更小的轴向间隙224，可提高灌注液在该处的灌注压力，降低血液流入驱动结构20内部造成血栓形成的风险。
相比传统将血泵壳体作为滑动轴承220的一部分与轴共同给构成滑动轴承220的方案，其不仅对血泵壳体的材料硬度及成形提出更高的要求，而且滑动轴承220的部分间隙224约束在2μm以下，尺寸小，加工困难，且容易造成转轴210在该处与外壳10卡死。本实施例的血泵的滑动轴承220为独立零件，单独加工成型，装配在转轴210与血泵的外壳10之间，加工简单，易于控制滑动轴承220的尺寸及间隙224；滑动轴承220依靠与转轴210之间的间隙224形成液力滑膜，该间隙224的存在降低转轴210与轴承的装配难度。
参照图3，可选地，在其中一实施例中，所述间隙224为2μm～5μm。本申请所提出的滑动轴承220依据用于人工心脏血泵这一特殊用途，为避免血细胞进入轴承和驱动结构20内腔，对该滑动轴承220与转轴210之间的间隙224进行了限定。该滑动轴承220与转轴210所构成的间隙224沿轴向可为均匀间隙224也可为非均匀间隙224。考虑到人体血液中的红细胞直径7μm～8.5μm，以及使灌注液在间隙224处维持较高灌注压力，为防止血液进入轴承，造成血细胞破坏，形成血栓风险，将滑动轴承220与转轴210之间的间隙224的径向长度限定为2μm～5μm。比如，间隙224为3μm、4μm等。
可选地，在其中一实施例中，所述滚动轴承230采用陶瓷材料制作，所述滚动轴承230的轴孔222的壁面具有耐磨涂层。滑动轴承220材质可选用陶瓷或其他高耐磨性材料，为提高轴承耐磨性，滑动轴承220内表面可做进一步耐磨涂层处理形成耐磨涂层，比如DLC涂层等。滑动轴承220采用陶瓷等高耐磨材料，提高滑动轴承220耐磨性，减少微粒产生， 保证转轴210高速运行的安全、可靠和稳定。
进一步地，在其中一实施例中，所述滚动轴承230包括内圈、外圈及设于外圈与内圈之间的滚珠，所述外圈与内圈通过所述滚珠转动连接，所述内圈与所述转轴210远离所述叶轮30的一端紧配。转轴210转动过程中，滚动轴承230的内圈随转轴210的近端转动，滚动轴承230的外圈不发生转动，给转轴210的近端提供径向支撑，使其转动平稳；转轴210的远端与滑动轴承220之间存在间隙224，滑动轴承220不随转轴210转动，由于间隙224处可通过灌注液形成滑膜，当转轴210的远端发生径向偏移时可受到被挤压液体提供的径向回复力，保证转轴210居中旋转，给转轴210的远端提供径向支撑，使其转动平稳。
在其中一实施例中，所述外壳10包括相连接的第一壳110与第二壳120，所述第一壳110开设有贯穿其壁面的出口窗101，所述叶轮30位于所述第一壳110内。所述滑动轴承220与滚动轴承230位于所述第二壳120内，所述转轴210由所述第二壳120伸入所述第一壳110内与所述叶轮连接。远端的血液在叶轮30的作用下进入第一壳110后由出口窗101泵出，灌注液灌注至第二壳120内由出口窗101流出，灌注液具有一定的灌注压力，大于叶轮30处血液的压力，避免第一壳110的血液进入第二壳120。灌注液在第二壳120内流动可带走驱动结构产生的热量，保证血泵工作的安全性及可靠性。灌注液可采用生理盐水或葡萄糖溶液等对血液无害的液体。
进一步地，在其中一实施例中，所述血泵还包括定子组件240及转子组件250，所述转子组件250固设于所述转轴210。所述定子组件240具有定子铁芯242与定子线圈244，所述定子铁芯242固设于所述第二壳120，所述定子线圈244位于所述转子组件250与所述定子铁芯242之间。即第二壳120作为独立于定子铁芯242的零件，置于定子铁芯212、定子线圈244及驱动机构外侧。在其他实施例中，所述第二壳120包括近端壳体122、远端壳体124及所述定子铁芯242。所述近端壳体122与所述远端壳体124分别与所述定子铁芯242的两端相连。所述定子线圈244位于所述转子组件250与所述定子铁芯242之间，所述远端壳体124与所述第一壳110连接。即定子铁芯242作为第二壳120的一部分，与两端的近端壳体122和所述远端壳体124共同组成置于定子线圈244及驱动机构外侧的第二壳120。如此设置，可减小血泵的体积，或者在不增大血泵体积的前提下，增大血泵内部的空间大小，便于优化血泵结构与性能。
在其中一实施例中，所述定子线圈244远离所述叶轮30的一端通过电缆与外部控制器连接。转子组件250与定子组件240可通过现有技术的原理实现对转轴210的驱动，在外部控制器的控制下驱动转轴210及与之连接的叶轮30高速旋转，叶轮30将从远端进入 第一壳110内的血液由出口窗101泵射出去。由作用力与反作用力的关系可知，转轴210会受到与血液流动方向相反的作用力。通过配合或者胶水粘接将近端滚动轴承230内圈与转轴210进行紧密连接，利用滚动轴承230的轴向承载能力，实现对血流反作用力的抵抗，保证转轴210在轴向上的平衡和稳定。
所述外壳10靠近叶轮30的一端的设有贯穿壁面的出口窗101；出口窗101绕外壳10周向设有多个。进一步地，所述外壳10远离叶轮30的一端设有灌注液流入口，灌注液由灌注液流入口进入外壳10内，依次沿滚动轴承230的滚珠之间、定子240与转子250之间及滑动轴承220与转轴210之间的空隙流至出口窗101流出外壳10。
参照图4、5，在其中一实施例中，所述滑动轴承220的外壁上设有凹槽226，所述凹槽226内用于填充粘接材料40以使所述滑动轴承220固定于所述外壳10的内壁。凹槽226中添加粘接材料40，将滑动轴承220沿轴向推进外壳10内腔中，当粘接材料40固化，滑动轴承220与外壳10牢固地粘接一起。滑动轴承220具有凹槽226结构，便于实现滑动轴承220与外壳10的粘接固定。
可选地，在其中一实施例中，所述凹槽226为绕所述滑动轴承220的中心线设置的环形槽或者弧形槽。固定用的凹槽226可为沿圆周方向360°连续，也可断续分布。参照图6、7，所述凹槽226的截面呈半圆形、方形或者锯齿形。图6示出了带方形凹槽226的滑动轴承220的示意图；图7示出了带半圆形凹槽226的滑动轴承220的示意图。
可选地，所述凹槽226包括1个或多个，多个所述凹槽226沿所述滑动轴承220的轴向间隔设置。图7示出了带双半圆形凹槽226的滑动轴承220的示意图。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (11)

  1. 一种血泵，其特征在于，包括外壳及设置于所述外壳内的驱动结构与叶轮，所述驱动结构包括转轴、滑动轴承及滚动轴承，所述转轴的一端与所述叶轮连接，所述滑动轴承、所述滚动轴承均与所述外壳固定连接，所述滑动轴承设有轴孔，所述滑动轴承通过所述轴孔套设于所述转轴靠近所述叶轮的一端，所述轴孔与所述转轴之间形成有间隙，所述滚动轴承套设于所述转轴远离所述叶轮的一端。
  2. 根据权利要求1所述的血泵，其特征在于，所述滑动轴承的外壁上设有凹槽，所述凹槽内用于填充粘接材料以使所述滑动轴承固定于所述外壳的内壁。
  3. 根据权利要求2所述的血泵，其特征在于，所述凹槽为绕所述滑动轴承的中心线设置的环形槽或者弧形槽，所述凹槽的截面呈半圆形、方形或者锯齿形。
  4. 根据权利要求2所述的血泵，其特征在于，所述凹槽包括1个或多个，多个所述凹槽沿所述滑动轴承的轴向间隔设置。
  5. 根据权利要求1所述的血泵，其特征在于，所述间隙为2μm～5μm。
  6. 根据权利要求1-5任一项所述的血泵，其特征在于，所述滚动轴承包括内圈、外圈及设于外圈与内圈之间的滚珠，所述外圈与内圈通过所述滚珠转动连接，所述内圈与所述转轴远离所述叶轮的一端紧配。
  7. 根据权利要求1-5任一项所述的血泵，其特征在于，所述外壳包括相连接的第一壳与第二壳，所述第一壳开设有贯穿其壁面的出口窗，所述叶轮位于所述第一壳内，所述滑动轴承与滚动轴承位于所述第二壳内，所述转轴由所述第二壳伸入所述第一壳内与所述叶轮连接。
  8. 根据权利要求7所述的血泵，其特征在于，所述血泵还包括定子组件与转子组件，所述转子组件固设于所述转轴，所述定子组件具有定子铁芯与定子线圈，所述定子铁芯固设于所述第二壳内，所述定子线圈位于所述转子组件与所述定子铁芯之间。
  9. 根据权利要求7所述的血泵，其特征在于，所述的血泵还包括定子组件与转子组件，所述转子组件固设于所述转轴，所述定子组件具有定子铁芯与定子线圈，所述第二壳包括近端壳体、远端壳体及所述定子铁芯，所述近端壳体与所述远端壳体分别与所述定子铁芯的两端相连，所述定子线圈位于所述转子组件与所述定子铁芯之间，所述远端壳体与所述第一壳连接。
  10. 根据权利要求1-5任一项所述的血泵，其特征在于，所述滚动轴承采用陶瓷材料制作，所述滚动轴承的轴孔的壁面具有耐磨涂层。
  11. 一种心脏辅助装置，其特征在于，包括灌注机构及权利要求1-10任一项所述的血泵，所述灌注机构与所述血泵远离所述叶轮的一端连接。
PCT/CN2023/070632 2022-04-22 2023-01-05 血泵及心脏辅助装置 WO2023202165A1 (zh)

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US20120101455A1 (en) * 2009-04-29 2012-04-26 Ecp Entwicklungsgesellschaft Mbh Shaft arrangement having a shaft which extends within a fluid-filled casing
CN111902168A (zh) * 2018-03-23 2020-11-06 阿比奥梅德欧洲股份有限公司 血管内血泵
CN212662465U (zh) * 2016-12-19 2021-03-09 阿比奥梅德公司 带有被动净化系统的心泵
WO2021191106A1 (en) * 2020-03-27 2021-09-30 Abiomed Europe Gmbh Blood pump
CN113726035A (zh) * 2021-09-03 2021-11-30 武汉万至达智能科技有限公司 一种高可靠性低温升可植入式微型电机
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CN200982351Y (zh) * 2006-12-08 2007-11-28 浙江双飞无油轴承有限公司 树脂材料直接贴附内衬式滑动轴承
US20120101455A1 (en) * 2009-04-29 2012-04-26 Ecp Entwicklungsgesellschaft Mbh Shaft arrangement having a shaft which extends within a fluid-filled casing
CN212662465U (zh) * 2016-12-19 2021-03-09 阿比奥梅德公司 带有被动净化系统的心泵
CN111902168A (zh) * 2018-03-23 2020-11-06 阿比奥梅德欧洲股份有限公司 血管内血泵
WO2021191106A1 (en) * 2020-03-27 2021-09-30 Abiomed Europe Gmbh Blood pump
CN215653408U (zh) * 2020-12-23 2022-01-28 上海微创心力医疗科技有限公司 轴承、血泵以及心室辅助循环装置
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