WO2018145434A1 - 叶轮交变旋转式悬浮离心血泵 - Google Patents

叶轮交变旋转式悬浮离心血泵 Download PDF

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Publication number
WO2018145434A1
WO2018145434A1 PCT/CN2017/097961 CN2017097961W WO2018145434A1 WO 2018145434 A1 WO2018145434 A1 WO 2018145434A1 CN 2017097961 W CN2017097961 W CN 2017097961W WO 2018145434 A1 WO2018145434 A1 WO 2018145434A1
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Prior art keywords
impeller
centrifugal
pump
suspension
cylinder
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PCT/CN2017/097961
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English (en)
French (fr)
Inventor
王改峰
张连喜
田步升
陈海丰
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长治市久安人工心脏科技开发有限公司
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Publication of WO2018145434A1 publication Critical patent/WO2018145434A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart 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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • A61M60/863—Apex rings
    • 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
    • A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
    • A61M60/232—Centrifugal 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
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor 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
    • A61M60/818—Bearings
    • A61M60/82—Magnetic 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • the invention relates to a heart-assisted impeller alternating rotary levitation centrifugal blood pump in the field of biomedical engineering, which comprises a magnetic levitation system, a front and a rear driving motor disc stator, a centrifugal impeller with a symmetrical structure and a symmetric centrifugal
  • the pump casing is composed; the centrifugal impeller rotates clockwise or counterclockwise to produce the same centrifugal blood flow.
  • the direction of rotation of the centrifugal impeller changes periodically, and the blood contact surface is washed by symmetrical blood flow, which can reduce the "dead zone" of slow blood flow in the pump and better prevent thrombosis.
  • the magnetic suspension technology is used to make the centrifugal impeller in suspension state, without mechanical bearing wear, which can prolong the working life of the blood pump, further improve the flushing of the blood pump and reduce the damage of blood components.
  • the centrifugal blood pump is a kind of implantable cardiac assist device, and has achieved good results in clinical treatment of advanced heart failure.
  • the long-term application of such devices may cause serious complications such as thromboembolism and hemorrhage, which is an important obstacle that hinders the progress of this technology.
  • Overcoming these difficulties requires further improvement and optimization of the structure of the centrifugal blood pump.
  • the basic structure of the centrifugal pump is a centrifugal pump casing and a centrifugal impeller placed in the cavity of the centrifugal pump casing.
  • the pump outlet is arranged in the outer peripheral part of the centrifugal pump casing, and the pump inlet is arranged in the center.
  • the centrifugal impeller of the centrifugal blood pump, the centrifugal pump casing and the pump outlet are all asymmetrically designed, and the pump outlet is connected to the centrifugal pump casing chamber in a tangential direction, and the outlet flow area is gradually enlarged.
  • Such a design can further increase the output pressure at the pump outlet by utilizing the tangential momentum of the rotating blood flow and the diffusion process in the flow channel, which is advantageous for improving the energy conversion efficiency of the centrifugal pump.
  • this structural design requires that the centrifugal impeller must rotate in a specific direction, and if the impeller rotates in the opposite direction, the working efficiency will be seriously degraded.
  • the structural design of the centrifugal blood pump is unique, and is not completely consistent with the structural design requirements of the centrifugal pump that drives other liquids.
  • the centrifugal pump structure must have as good a blood compatibility as possible, that is, a good anti-thrombosis and as little as possible damage of blood components.
  • the impeller of the centrifugal blood pump and the inner wall of the centrifugal pump chamber are surfaces that are in direct contact with the blood. These factors are activated by contact of foreign matter with active factors in the blood, which may cause blood to coagulate and adhere to the surface of these foreign bodies to form a thrombus.
  • the centrifugal impeller rotates in one direction to fix the flow field in the centrifugal pump casing, and it is easy to form some areas with poor blood flow erosion, such as the corresponding area of the low pressure surface of the impeller blades, etc. Irregular scouring, these characteristics are not conducive to preventing thrombosis in the pump.
  • the US HeartMate III implantable centrifugal blood pump adopts a driving strategy that periodically changes the impeller speed.
  • the flow field in the centrifugal pump chamber can be changed at different speeds, which can be to some extent. Improve the flushing effect in the cavity of the centrifugal pump and the surface of the impeller.
  • this driving method requires a symmetrical design of the centrifugal pump casing and the centrifugal impeller to ensure that the fluid output characteristics are the same when the impeller rotates in two opposite directions.
  • the invention provides an impeller alternating rotary suspension centrifugal blood pump, which can realize the above working mechanism.
  • the sliding bearing can be used as the supporting structure of the centrifugal impeller, but its biggest disadvantage is the friction, wear and local temperature rise of the sliding contact surface, and the poor area of the blood flow can be formed around the mechanical bearing, and the thrombus is easily formed.
  • the magnetic control is used to make the rotating impeller in suspension during operation, and the mechanical wear is removed to further prolong the working life of the blood pump. No local frictional heat generation and local temperature rise are more conducive to preventing thrombosis. These improvements can further improve the centrifugal blood pump. performance.
  • the present invention provides an impeller alternating rotary suspension centrifugal blood pump.
  • the pump casing, the pump inlet, the pump outlet and the centrifugal impeller of the centrifugal blood pump adopt a symmetrical structure; the centrifugal impeller is supported by a magnetic levitation system, and the radial position thereof is restricted by a permanent magnet bearing; the axial position is controlled by an electromagnetic device, and the radial permanent magnet Combined with axial electromagnetic bearing control can realize centrifugal impeller 5
  • the degree of freedom constraint maintains the centrifugal impeller in a fully suspended state without mechanical contact.
  • the stator of the driving motor is a disc type, and the stators of the two disc motors rotate the centrifugal impeller in a clockwise or counterclockwise direction by a rotating magnetic field, thereby driving the blood flow to rotate, and the blood flow is driven by the centrifugal force of the rotating flow to flow out from the pump outlet.
  • the impeller alternating rotary levitation centrifugal blood pump is composed of a driving motor, a centrifugal pump casing, a centrifugal impeller and a centrifugal impeller magnetic levitation system; the centrifugal pump casing is divided into a centrifugal pump cylinder at the front end and a blade chamber at the rear end, and the blade cavity is cylindrical, at A cylindrical outlet wall of the vane cavity is provided with a pump outlet perpendicular to the tangent to the wall and is symmetrical with respect to the reference plane.
  • the stator of the drive motor is a disc stator, and the two disc stators are respectively located at the front and rear ends of the vane cavity and correspond to the rotor permanent magnets in the impeller vane.
  • the impeller cylinder of the centrifugal impeller is located in the centrifugal pump cylinder, and the impeller blades are attached to the tail end of the impeller cylinder.
  • the impeller blades are four pieces, and are symmetrically arranged along the radial direction of the impeller cylinder, and are located in the blade cavity.
  • the front and rear sets of permanent magnet radial bearings are respectively composed of front and rear stator suspension magnetic rings and front and rear rotor suspension magnetic rings; the front and rear stator suspension magnetic rings are wrapped around the outer wall of the centrifugal pump cylinder, front and rear.
  • the rotor suspension magnetic ring is embedded in the impeller cylinder of the centrifugal impeller; a suspension gap is arranged between the outer wall of the impeller cylinder and the inner wall of the centrifugal pump cylinder, and is connected with the vane cavity to form a blood flow secondary flow passage.
  • the front and rear stator suspension magnetic rings and the front and rear rotor suspension magnetic rings are axially magnetized and have the same axial length, corresponding positions, and the polarities are arranged in the same direction, thereby generating magnetic repulsion between the stator and the rotor suspension magnetic ring.
  • the force limits the radial displacement of the impeller.
  • the inner wall of the impeller tube forms a tubular passage, which is in communication with the vane chamber, and is a mainstream flow of blood flowing into the vane chamber.
  • the front end opening of the centrifugal pump barrel is the pump inlet, which is connected to the blood flow main channel and the blood flow secondary flow channel.
  • the pump inlet When the blood pump is working, most of the blood flow is guided by the main channel.
  • a small part of the blood flow is guided by the auxiliary flow channel into the leaf cavity by the pump inlet, and flows out from the pump outlet under the action of centrifugal force; flows through the main flow channel and blood flow pair.
  • the blood flow of the flow channel can continuously flush the inner and outer wall surfaces of the impeller tube and the inner wall surface of the centrifugal pump barrel to prevent thrombus formation and adhesion.
  • the axially magnetized cylindrical axial control permanent magnet is embedded in the impeller cylinder, and is located between the front and rear rotor suspension magnetic rings; the axial control permanent magnet midpoint corresponds to the midpoint of the axial control coil.
  • the axially controlled permanent magnet and the front and rear rotor suspension magnetic rings embedded in the impeller cylinder are strictly concentric with the impeller cylinder.
  • the guiding vertebral body is arranged at the center of the rear wall of the blade cavity, so that the axial blood flow entering the blade cavity of the main channel can be dispersed to the outside to form a swirling flow to prevent eddy current formation.
  • the guiding vertebral body is a cavity, and a cavity sensor is arranged in the cavity. The sensor can determine the axial position of the centrifugal impeller by measuring the magnetic field strength variation of the rear rotor floating magnetic ring, and provide position feedback for the floating feedback controller. signal.
  • the outer wall of the centrifugal pump barrel is wound around the ring The windings form an axial control coil located between the front and rear stator suspension magnetic rings, corresponding to the position of the axially controlled permanent magnets in the impeller cylinder.
  • the current intensity and direction in the axial control coil are changed in real time, and the axial electromagnetic field is generated to control the axial position of the impeller.
  • the centrifugal impeller Under the cooperation of the front and rear radial permanent magnet bearings, the centrifugal impeller can be kept in full suspension. status.
  • the centrifugal impeller can rotate periodically or clockwise to drive the blood to rotate at the same speed.
  • the centrifugal force of the rotating flow can be Drive blood out of the pump outlet.
  • FIG. 1 is a cross-sectional view of the impeller alternating rotary levitation centrifugal blood pump of the present invention along a reference plane
  • FIG. 2 is a schematic view of the reference surface and the appearance
  • FIG. 3 is a schematic view of the appearance of the present invention
  • FIGS. 4 and 5 are schematic views of the centrifugal impeller of the present invention.
  • Figure 1 Figure 2, Figure 3, 1. pump inlet, 2. main flow, 3. front rotor suspension magnetic ring, 4. front stator suspension magnetic ring, 5. axial control magnet, 6. axial control winding 7.
  • the outer wall of the pump cylinder, 8. The inner wall of the pump cylinder, 9.
  • the rear stator suspension magnetic ring 10. The front wall of the blade cavity, 11.
  • the rear drive motor disc stator 13.
  • the pump outlet 14. the posterior wall of the blade cavity, 15. the diversion vertebral body, 16. the drive motor rotor magnet, 17. the impeller blade, 18. the Hall sensor, 19. the blade cavity, 20. the sewing ring, 21. the rear rotor suspension magnetic ring , 22, auxiliary flow, 23. impeller tube, 24. inner wall of impeller tube, 25. outer wall of impeller tube, 26. pump tube, 27. centrifugal pump casing, 28. butt end face, 29. centrifugal impeller, 30. 31. Signal and power line interface.
  • the centrifugal impeller (29) is composed of an impeller cylinder (23) at the front end and an impeller blade (17) attached at the rear end, and the impeller cylinder (23) is composed of an impeller.
  • the impeller blade (17) is a dovetail, a total of 4 pieces, attached At the end of the impeller tube, and arranged along the axis of the radial, impeller
  • the rotor magnet (16) is embedded in the blade and is axially magnetized.
  • the centrifugal pump casing (27) is composed of a pump cylinder (26) at the front end and a blade chamber (11) at the rear end, and the front end of the centrifugal pump casing (27)
  • the pump cylinder (26) is a tubular cavity surrounded by the outer wall of the pump cylinder (7) and the inner wall of the pump cylinder (8).
  • the front and rear stator suspension magnetic rings (4) and (9) are embedded in the cavity and the axial control Winding (6); the axial control winding (6) is located between the front and rear stator suspension magnetic rings (4) and (9) and is wound concentrically outside the inner wall (8) of the pump cylinder.
  • the impeller cylinder (23) and the impeller blades (17) are respectively arranged in the pump cylinder (26) and the centrifugal pump casing (27), concentrically arranged coaxially; between the outer wall surface of the impeller cylinder (23) and the inner wall surface of the pump cylinder (26)
  • the gap forms a secondary flow channel (22) of the blood flow
  • the cavity in the inner wall (26) of the impeller tube forms a blood flow main channel (2)
  • the axial control magnet (5) is divided into two sections, the front and the back, and the length of the two sections Equally, both axially magnetized and butted to form abutting end faces (28), the position of the butt end faces (28) corresponding to the intermediate point of the axial control windings; when the axial control windings (6) are fed
  • the axial magnetic field pushes the axial control magnet (5) to move forward or backward.
  • the impeller cylinder (23) is embedded with a front rotor suspension magnetic ring (3) and a rear rotor suspension magnetic ring (21), respectively, with a front stator suspension magnetic ring (4) and a rear stator suspension magnetic ring in the pump cylinder (26) ( 9)
  • the position corresponds and is strictly concentric with the pump barrel;
  • the front rotor suspension magnetic ring (3), the rear rotor suspension magnetic ring (21), the front stator suspension magnetic ring (4) and the rear stator suspension magnetic ring (9) are axial Magnetization, the axial length is equal and the magnetic poles are arranged in the same direction, and the radial displacement of the impeller cylinder (23) and the impeller blades (17) is restricted by the magnetic repulsive force between the floating magnetic rings to form the front and rear permanent magnet radial suspension bearings;
  • a drive motor rotor magnet (16) is embedded in the impeller blade (17), and the magnet is axially magnetized and coupled to the disc-shaped drive motor stator (11), (12) outside
  • the position corresponds to a rotating magnetic field that feeds the centrifugal impeller during feeding.
  • the outer surface of the axial control winding (6), the front stator suspension magnetic ring (4) and the rear stator suspension magnetic ring (9) has a sealed outer wall of the pump cylinder (7), and the outer wall of the pump cylinder (7) is surrounded by the rear end. Sewing ring (20).
  • the pump barrel (26) When implanted in the human body, the pump barrel (26) is inserted into the left ventricular cavity through the apical incision, the sewing ring (20) is sutured on the apical myocardium surface, the centrifugal pump casing (27) is placed in the pericardial cavity, and the outlet is passed through the artificial blood vessel. Aortic anastomosis.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
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  • Structures Of Non-Positive Displacement Pumps (AREA)

Abstract

一种叶轮交变旋转式悬浮离心血泵，由对称结构离心叶轮（29）及对称结构离心泵壳（27）组成；离心叶轮（29）依正、反方向旋转均可产生相同的离心血流输出。叶轮筒（23）外壁与泵筒（26）内壁间隙为血流副流道（22），叶轮筒内壁（24）中的空腔为血流主流道（2）；轴向控制绕组（6）馈电时可推动轴向控制磁体（5）前、后运动；前转子悬浮磁环（3）和后转子悬浮磁环（21）与前定子悬浮磁环（4）和后定子悬浮磁环（9）形成前、后永磁径向悬浮轴承；叶轮叶片（17）内镶驱动电机转子磁体（16）与离心泵壳（27）前、后壁（10）、（14）外的盘状驱动电机定子（11）、（12）对应。泵筒外壁（7）后端包绕缝合环（20）。

Description

叶轮交变旋转式悬浮离心血泵 技术领域
本发明涉及一种生物医学工程领域用于心脏辅助的叶轮交变旋转式悬浮离心血泵，由磁悬浮系统、前、后驱动电机盘式定子、以基准面为对称结构的离心叶轮及对称的离心泵壳组成；离心叶轮依顺时针或逆时针方向旋转均可产生相同的离心血流。离心叶轮旋转方向周期性改变，血液接触表面受到对称的血流冲刷，可减少泵内血流缓慢的“死区”，更好地防止血栓形成。采用磁悬浮技术使离心叶轮处于悬浮状态，无机械轴承磨损，可延长血泵的工作寿命，进一步提高血泵内冲刷，减轻对血液成份的破坏。
背景技术
离心血泵是植入式心脏辅助装置的一种，临床治疗晚期心衰取得了良好效果。但长时间应用此类装置会出现血栓栓塞、出血等严重并发症，是目前阻碍此技术进步的重要困难。克服这些困难需进一步改进和优化离心血泵的结构。离心泵基本结构是离心泵壳和置于离心泵壳腔中的离心叶轮。离心泵壳的外周部位设置泵出口，中心设置泵入口，液流由泵入口进入离心泵壳内，离心叶轮高速旋转驱动液体形成旋转流，在离心力的作用下液体从泵出口流出。通常，离心血泵的离心叶轮、离心泵壳及泵出口均采用不对称设计，泵出口以切线方向与离心泵壳腔相联通，出口的过流面积逐步扩大。这样的设计可在泵出口处利用旋转血流的切向动量和在流道中的扩散过程进一步增加输出压力，有利于提高离心泵的能量转化效率。但这种结构设计要求离心叶轮必须按照特定方向旋转，如果叶轮反向旋转则会导致工作效率严重下降。
离心血泵的结构设计有特殊性，与驱动其他液体的离心泵的结构设计要求不完全一致。比如离心泵结构必须有尽可能良好的血液相容性，即要求良好的抗血栓和尽可能轻微的血液成分损伤的特性。离心血泵的叶轮及离心泵壳腔内壁是与血液直接接触的表面，由于异物与血液中的活性因子接触使这些因子激活，可导致血液凝固并附着在这些异物表面形成血栓。通常在血流缓慢的“死区”更容 易形成血栓，也容易形成血液成分的破坏和损伤。去除液流缓慢的“死区”及对异物表面的良好的血流冲刷可防止血栓形成和附着，减小血液成分的破环。由此可见，离心血泵的结构设计应该尽可能防止血流相对缓慢的“死区”形成。
采用传统的离心泵结构，离心叶轮单方向旋转使离心泵壳内的流场形式固定，容易形成一些血流冲刷不良的区域，如叶轮叶片的低压面相对应的区域等，泵内各表面血流冲刷不均匀，这些特点不利于防止泵内血栓形成。为了克服这一缺点，美国的HeartMate III植入式离心血泵采用了周期性改变叶轮转速的驱动策略，离心泵壳腔内的流场形式可在不同的转速下改变，这样可在一定程度上改善离心泵壳腔内和叶轮各表面的冲刷效果。但这种驱动策略仍然不能使离心泵壳内各个表面等到均等的冲刷。设想离心叶轮可周期性顺时针和逆时针交替旋转，那么，离心泵壳内血流旋转方向将周期性反转，离心叶轮及离心泵壳内各表面均可得到血流的对称冲刷，可最大限度地去除离心泵壳腔内的液流“死区”，提高血泵的抗血栓特性。但这种驱动方式要求离心泵壳及离心叶轮等结构采用对称设计，以便保证叶轮在两个相反方向旋转时流体输出特性相同。本发明提出一种叶轮交变旋转式悬浮离心血泵，可实现上述工作机制。
支撑离心叶轮的轴承是另一关键技术。滑动轴承可作为离心叶轮的支撑结构，但其最大的缺点是滑动接触面的摩擦、磨损和局部温度升高，且在机械轴承周围还可形成血流冲刷不良区域，容易形成血栓。采用磁力控制使旋转叶轮在工作时处于悬浮状态，去除机械磨损使血泵工作寿命进一步延长，没有局部摩擦产热及局部温升更有利于防止血栓形成，这些改进均可进一步改善离心血泵的性能。
技术问题
问题的解决方案
技术解决方案
为了减少并发症，改善植入式心脏辅助装置的整体性能，本发明提供一种叶轮交变旋转式悬浮离心血泵。所述离心血泵的泵壳、泵入口、泵出口及离心叶轮采用对称结构；离心叶轮由磁悬浮系统支撑，其径向位置采用永磁轴承制约；轴向位置由电磁装置控制，径向永磁和轴向电磁轴承联合控制可实现离心叶轮的5 自由度约束，维持离心叶轮处于无机械接触的全悬浮状态。驱动电机定子为盘式，两个盘式电机定子通过旋转磁场驱动离心叶轮周期性顺时针或逆时针方向转动，进而带动血流旋转，通过旋转流的离心力驱动血流由泵出口流出。
本发明解决其技术问题所采用的技术方案是：
叶轮交变旋转式悬浮离心血泵由驱动电机、离心泵壳、离心叶轮和离心叶轮磁悬浮系统组成；离心泵壳分为前端的离心泵筒和后端的叶片腔，叶片腔为圆筒状，在叶片腔的筒状圆周壁上设置与壁面切线垂直的泵出口且相对于基准面对称。驱动电机的定子为盘式定子，两片盘式定子分别位于叶片腔的前、后两端且与叶轮叶片中的转子永磁体相对应。离心叶轮的叶轮筒位于离心泵筒中，在叶轮筒的尾端附着叶轮叶片，叶轮叶片为四片，沿叶轮筒的径向辐射状对称排列，位于叶片腔中。设置前、后两组永磁径向轴承，分别由前、后定子悬浮磁环和前、后转子悬浮磁环组成；前、后定子悬浮磁环均包绕在离心泵筒外壁，前、后转子悬浮磁环包埋在离心叶轮的叶轮筒内；叶轮筒外壁和离心泵筒内壁之间设置悬浮间隙，与叶片腔相联通，形成血流副流道。前、后定子悬浮磁环与前、后转子悬浮磁环均为轴向充磁且轴向长度相等，位置对应，极性同向排列，由此定子和转子悬浮磁环之间产生的磁排斥力可限制叶轮径向位移。叶轮筒内壁形成管状通道，与叶片腔相联通，是血流进入叶片腔的血流主流道。离心泵筒的前端开口为泵入口，与血流主流道和血流副流道相联通。血泵工作时大部分血流由主流道引导，少部分血流由副流道引导由泵入口进入叶片腔内，在离心力的作用下从泵出口流出；流经血流主流道和血流副流道的血流可对叶轮筒的内、外壁面及离心泵筒的内壁面进行持续冲刷，防止血栓形成和附着。叶轮筒内还包埋有轴向充磁的筒形轴向控制永磁体，位于前、后转子悬浮磁环之间；轴向控制永磁体中点与轴向控制线圈中点位置对应。叶轮筒内包埋的轴向控制永磁体和前、后转子悬浮磁环均与叶轮筒严格同心同轴。
叶片腔的后壁中心设置导流椎体，可使主流道进入叶片腔内的轴向血流向外周分散，形成旋转流，防止涡流形成。导流椎体内为空腔，所述空腔内设置霍尔传感器，该传感器可通过对后转子悬浮磁环的磁场强度变化测量确定离心叶轮的轴向位置，为悬浮反馈控制器提供位置反馈信号。离心泵筒的外壁缠绕环形 绕组，形成轴向控制线圈，位于前、后定子悬浮磁环之间，与叶轮筒内的轴向控制永磁体位置对应。在悬浮反馈控制器的控制下轴向控制线圈中电流强度和方向实时改变，产生轴向电磁场控制叶轮轴向位置；在前、后径向永磁轴承的配合下，离心叶轮可保持在全悬浮状态。
发明的有益效果
有益效果
由于离心叶轮、离心泵壳、泵入口及泵出口均为以基准面左、右对称结构，所以离心叶轮周期性顺时针或逆时针方向旋转均可带动血液以同样速度旋转，旋转流的离心力可驱动血液从泵出口流出。
对附图的简要说明
附图说明
图1是本发明叶轮交变旋转式悬浮离心血泵沿基准面的剖面图，图2是基准面和外观示意图，图3是本发明的外观示意图，图4、图5是本发明离心叶轮的外观示意图。在图1、图2、图3中，1.泵入口，2.主流道，3.前转子悬浮磁环，4.前定子悬浮磁环，5.轴向控制磁体，6.轴向控制绕组，7.泵筒外壁，8.泵筒内壁，9.后定子悬浮磁环，10.叶片腔前壁，11.前驱动电机盘式定子，12.后驱动电机盘式定子，13.泵出口，14.叶片腔后壁，15.导流椎体，16.驱动电机转子磁体，17.叶轮叶片，18.霍尔传感器，19.叶片腔，20.缝合环，21.后转子悬浮磁环，22.副流道，23.叶轮筒，24.叶轮筒内壁，25.叶轮筒外壁，26.泵筒，27.离心泵壳，28.对接端面，29.离心叶轮，30.基准面，31.信号及电源线接口。
实施该发明的最佳实施例
本发明的最佳实施方式
下面结合附图和实施例对本发明进一步说明：
在图1、图2、图3、图4和图5中，离心叶轮(29)由前端的叶轮筒(23)和尾端附着的叶轮叶片(17)组成，叶轮筒(23)是由叶轮筒外壁(25)和叶轮筒内壁(24)包绕的管状空腔，空腔内包埋有筒形的轴向控制磁体(5)；叶轮叶片(17)为燕尾状，共4片，附着在叶轮筒的尾端，且沿轴心辐射状排列，叶轮 叶片内包埋轴向充磁的驱动电机转子磁体(16).离心泵壳(27)是由前端的泵筒(26)和尾端的叶片腔(11)组成，离心泵壳(27)前端的泵筒(26)是由泵筒外壁(7)和泵筒内壁(8)包绕的管状空腔，空腔内包埋前、后定子悬浮磁环(4)和(9)及轴向控制绕组(6)；轴向控制绕组(6)位于前、后定子悬浮磁环(4)和(9)之间，且以同心方式缠绕在泵筒内壁(8)外。叶轮筒(23)和叶轮叶片(17)分别位于泵筒(26)和离心泵壳(27)中，同心同轴排列；叶轮筒(23)的外壁面与泵筒(26)的内壁面间的间隙形成血流的副流道(22)，叶轮筒内壁(26)中的空腔形成血流主流道(2)；轴向控制磁体(5)分为前、后两段，两段长度相等，均轴向充磁且以同性磁极端对接形成对接端面(28)，对接端面(28)的位置对应于轴向控制绕组的中间点；当轴向控制绕组(6)馈电时可产生轴向磁场推动轴向控制磁体(5)向前或向后运动。
叶轮筒(23)内镶嵌有前转子悬浮磁环(3)和后转子悬浮磁环(21)，分别与泵筒(26)内的前定子悬浮磁环(4)和后定子悬浮磁环(9)位置对应且严格与泵筒同心；前转子悬浮磁环(3)、后转子悬浮磁环(21)、前定子悬浮磁环(4)和后定子悬浮磁环(9)均为轴向充磁，轴向长度相等且磁极排列方向相同，各悬浮磁环间通过磁排斥力限制叶轮筒(23)和叶轮叶片(17)的径向位移，形成前、后永磁径向悬浮轴承；叶轮叶片(17)内镶嵌驱动电机转子磁体(16)，该磁体轴向充磁且与离心泵壳前、后壁(10)、(14)外的盘状驱动电机定子(11)、(12)位置对应，馈电时产生旋转磁场推动离心叶轮旋转。轴向控制绕组(6)、前定子悬浮磁环(4)和后定子悬浮磁环(9)的外表面有密封包绕的泵筒外壁(7)，泵筒外壁(7)后端包绕缝合环(20)。当植入人体时，泵筒(26)通过心尖切口插入到左心室腔内，将缝合环(20)缝合在心尖心肌表面，离心泵壳(27)放置在心包腔内，出口通过人造血管与主动脉吻合联通。

Claims (17)

  1. 一种用于心脏辅助的叶轮交变旋转式悬浮离心血泵，由离心叶轮、离心泵壳、离心泵入口、离心泵出口、前、后驱动电机盘式定子及磁悬浮系统组成；所述叶轮交变旋转式悬浮离心血泵有一基准面的对称剖面，离心叶轮、离心泵壳、离心泵入口和离心泵出口均以基准面为准左、右对称，离心叶轮工作时依顺时针和逆时针方向交变旋转；离心叶轮由磁悬浮系统控制处于全悬浮状态；前、后驱动电机盘式定子产生的旋转磁场驱动离心叶轮旋转1。
  2. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，对称结构的离心叶轮在控制下以顺时针和逆时针方向旋转，改变离心叶轮旋转方向可以是周期性或非周期性，也可以根据治疗需要确定。
  3. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，离心泵壳由前端的泵筒和后端的叶片腔组成，离心叶轮由前端的叶轮筒及后端的叶轮叶片组成，叶轮筒位于离心泵壳的泵筒内，叶轮叶片位于离心泵壳的叶片腔内，离心泵壳和离心叶轮同轴同心设置。
  4. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，设置于离心泵壳内的离心叶轮在磁悬系统控制下实现五自由度悬浮，所述磁悬浮系统由前、后径向磁悬浮轴承及轴向电磁控制系统组成。
  5. 根据权利要求3所述的离心叶轮，叶轮筒是由叶轮筒外壁和叶轮筒内壁包绕的管状空腔，空腔内包埋有筒形的轴向控制磁体；叶轮叶片为燕尾状，共4片，附着在叶轮筒的尾端，且以叶轮筒轴心为中心沿叶轮筒的径向辐射排列，并以对称纵剖面左右对称；叶轮叶片内包埋轴向充磁的驱动电机转子磁体。
  6. 根据权利要求3所述的离心泵壳，离心泵壳的泵筒是由泵筒外壁和泵筒内壁包绕的管状空腔，空腔内包埋前、后定子悬浮磁环及轴向控制绕组；轴向控制绕组位于前、后定子悬浮磁环之间，且以同心方式缠绕在泵筒内壁外。
  7. 根据权利要求4所述的前、后径向磁悬浮轴承，前径向磁悬浮轴承 由前定子悬浮磁环和前转子悬浮磁环组成，后径向磁悬浮轴承由后定子悬浮磁环和后转子悬浮磁环组成；前、后定子悬浮磁环和前、后转子悬浮磁环均轴向充磁；叶轮筒前端包埋前转子悬浮磁环，泵筒前端包埋前定子悬浮磁环，前转子悬浮磁环和前定子悬浮磁环位置相对，轴向长度相等且磁极排列方向相同，形成前磁悬浮轴承；叶轮筒后端包埋后转子悬浮磁环，泵筒后端包埋后定子悬浮磁环，后转子悬浮磁环和后定子悬浮磁环位置相对，轴向长度相等且磁极排列方向相同，形成后径向磁悬浮轴承。
  8. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，驱动电机转子磁体轴向充磁，包埋在离心叶轮叶片内，与前、后驱动电机盘式定子位置对应。
  9. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，叶轮筒的外壁面与泵筒的内壁面间的悬浮间隙形成血流副流道，叶轮筒内壁中的空腔形成血流主流道。
  10. 根据权利要求3所述的叶片腔，在所述叶片腔的后壁中心设置导流椎体，导流椎体中心为空腔，在导流椎体的空腔内设置霍尔传感器。
  11. 根据权利要求4所述的轴向电磁控制系统，叶轮筒中段的叶轮筒外壁内包埋有轴向充磁的轴向控制永磁体，泵筒中段的泵筒外壁内包埋轴向控制绕组，位置与轴向控制永磁体对应；轴向控制绕组的线圈轴心与泵筒同轴，馈电时在泵筒内空间产生轴向磁场。
  12. 根据权利要求11所述的轴向控制永磁体，轴向控制永磁体分为前、后两段，两段长度相等，均轴向充磁且以同性磁极端对接形成对接端面，对接端面的位置对应于轴向控制绕组的中间点。
  13. 根据权利要求4所述的轴向电磁控制系统，在导流椎体空腔内设置的霍尔传感器可探测后转子悬浮磁环的磁场变化，输出与离心叶轮轴向位置相关的电信号，通过连接导线输送到悬浮反馈控制器。
  14. 根据权利要求4所述的轴向电磁控制系统，设置悬浮反馈控制器，所述悬浮反馈控制器根据霍尔传感器输出的电信号通过连接导线对轴向控制绕组的馈电方向和强度实行控制。
  15. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，泵筒的前端开口为泵入口，叶片腔外周设置泵出口，泵入口通过主流道和副流道与叶片腔及泵出口相联通，引导泵入口的血液流入泵壳叶片腔内。
  16. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，叶片腔的前壁外设置前驱动电机盘式定子；叶片腔的后壁外设置后驱动电机盘式定子。
  17. 根据权利要求1所述的叶轮交变旋转式悬浮离心血泵，前、后驱动电机盘式定子各绕组的馈电顺序由控制程序定时改变，离心叶轮在定子磁场的驱动下周期性改变方向，分别依顺时针和逆时针两个方向旋转。
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CN113730792A (zh) * 2021-09-24 2021-12-03 北京航空航天大学 一种体外循环磁悬浮混流血泵
CN113819072A (zh) * 2021-10-18 2021-12-21 杭州旋速科技有限公司 一种涡扇磁悬浮管道风机
CN114593085A (zh) * 2022-02-25 2022-06-07 北京航天动力研究所 一种采用空间悬浮轴承的长寿命温控泵系统
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US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
CN113730792B (zh) * 2021-09-24 2022-09-27 北京航空航天大学 一种体外循环磁悬浮混流血泵
CN113730792A (zh) * 2021-09-24 2021-12-03 北京航空航天大学 一种体外循环磁悬浮混流血泵
CN113819072A (zh) * 2021-10-18 2021-12-21 杭州旋速科技有限公司 一种涡扇磁悬浮管道风机
CN113819072B (zh) * 2021-10-18 2023-08-22 杭州旋速科技有限公司 一种涡扇磁悬浮管道风机
CN114593085A (zh) * 2022-02-25 2022-06-07 北京航天动力研究所 一种采用空间悬浮轴承的长寿命温控泵系统
CN114593085B (zh) * 2022-02-25 2024-03-15 北京航天动力研究所 一种采用空间悬浮轴承的长寿命温控泵系统
CN116780817A (zh) * 2023-08-21 2023-09-19 航天泰心科技有限公司 一种用于介入式导管泵的微型电机

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