WO2015039605A1 - Implanted self-suspended axial flow blood pump - Google Patents

Implanted self-suspended axial flow blood pump Download PDF

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Publication number
WO2015039605A1
WO2015039605A1 PCT/CN2014/086750 CN2014086750W WO2015039605A1 WO 2015039605 A1 WO2015039605 A1 WO 2015039605A1 CN 2014086750 W CN2014086750 W CN 2014086750W WO 2015039605 A1 WO2015039605 A1 WO 2015039605A1
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WIPO (PCT)
Prior art keywords
stator
blood pump
magnetic steel
suspended
pump according
Prior art date
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PCT/CN2014/086750
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French (fr)
Chinese (zh)
Inventor
刘中民
范慧敏
周连第
陈应生
金如麟
叶亮
Original Assignee
上海微创医疗器械(集团)有限公司
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Publication of WO2015039605A1 publication Critical patent/WO2015039605A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/422Details 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804Impellers
    • A61M60/806Vanes or blades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable 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
    • A61M60/148Implantable 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

Definitions

  • the present invention relates to the field of medical device technology, and in particular to an implantable ventricular assist device.
  • Heart failure (heart failure) is the most common diagnosis of cardiovascular patients, and it is also the disease with the highest medical cost. Internationally, heart failure has been an important issue to be solved in this century. Due to the lack of donors, approximately 30% of patients preparing for heart transplantation die of cardiac function deterioration while waiting for heart delivery.
  • Ventricular Assist Devices VAD
  • NASH National Institutes of Health
  • RFPs Request For Proposals
  • ventricular assist devices As one of the methods of heart failure treatment.
  • the pump system of the general ventricular assist device uses the domestic VZ-IIA blood pump and the Berlin Heart Incor 1 as an example, and the motor magnetic steel rotor, the blood pump rotor and the bearing or the magnetic levitation control body are placed in the blood flow channel, so that not only The volume and weight of the entire pump system is increased, and the placement of the rotor magnet and the magnetic levitation control body in the blood flow path also greatly reduces the blood flow, and the air gap between the stator and the rotor of the motor increases, and the required power also increases.
  • the existing implantable bearing blood pump on the market the bearing is easy to wear, easy to vibrate, short service life, low reliability, and easy to form a thrombus.
  • the magnetic levitation control system of the magnetic levitation blood pump has a complicated structure, a large volume, a heavy weight, and high requirements on parameters such as control operation balance and vibration amplitude. Therefore, the clinical application of the ventricular assist device not only requires small size, light weight, and is not easy to thrombosis, but also requires the device to operate in balance, low vibration, and low noise, so as to improve the comfort of the patient during use.
  • the object of the present invention is to provide an implantable self-suspended axial blood pump, which is smaller in volume, lighter in weight, does not stop rotating due to mechanical failure of the bearing, has higher reliability, and avoids the position at the bearing. Form a thrombus.
  • an embodiment of the present invention discloses an implantable self-suspended shaft blood flow pump comprising: a stator and a rotor, wherein the stator includes: a stator core (2), a stator coil (3), and a motor bracket ( 4); the rotor includes: a magnetic steel (5) containing a magnetic material and a built-in paddle (8);
  • the radial direction from the inside to the outside is: built-in paddle (8), magnetic steel (5), motor bracket (4), stator coil (3) and stator core (2) ;
  • the rotor comprises a hollow annular magnetic steel and a built-in paddle fixed therein, the rotor is directly placed in the middle of the stator, and the stator and the rotor are not directly or indirectly connected by bearings, and the rotor is self-detached from the contact with the inner wall of the stator when rotating. Self-suspending state. Because there is no bearing or magnetic suspension control system, the blood pump is smaller and lighter.
  • the present invention does not stop the rotation due to mechanical failure of the bearing, is more reliable, and avoids the formation of a thrombus at the bearing position. At the same time, no complicated magnetic levitation control system is needed. The cost of the blood pump is lower and the reliability is better.
  • stator coil (3) adopts a hollow cup winding, which not only solves the problem that the small-sized stator is difficult to go offline, but also has no cogging in the stator core, completely eliminating the essential rotation caused by the tooth harmonic magnetic field. fluctuation.
  • the structure with the built-in paddle (8) in front and the outer paddle (9) in the back can ensure that the blood enters the flow channel first, and is firstly subjected to the rotation of the blade by the built-in paddle (8) to ensure maximum Part of the blood passes through the main channel, and the trace blood passes through the tip of the outer blade (9) disposed at the back, which ensures that the blood smoothly branches in the main and branch channels, smoothly passes, and does not cause congestion. Thrombosis.
  • the leaf cut surface of the built-in blade (8) and the outer blade (9) adopts a blade-shaped blade shape of a marine ducted propeller, and when blood flows through the airfoil-shaped cut surface, a positive surface appears on the leaf cut surface.
  • Pressure, negative pressure on the leaf back of the leaf cut surface, the pressure difference between the leaf surface and the leaf back can improve the efficiency of the blood pump and increase the pressure head.
  • the two-phase conduction, three-phase six-state conduction mode not only improves the utilization of the winding, reduces the volume and weight, but also reduces the magnetic state angle and reduces the rotational fluctuation.
  • outlet right-handed stator (7) is fixed to the motor bracket (4) to adjust the direction of blood flow outflow.
  • the circuit realizes the function of identifying the position of the rotor and the self-starting function, and functions as a position sensor, which can cancel the conventional position sensor, thereby reducing the difficulty of sealing, improving the reliability, simplifying the structure, and reducing the structure. volume.
  • the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, preferably between 0.0042D and 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5).
  • the range of D is preferably between 5 and 32 mm, more preferably between 6.7 and 25 mm, which has the best effect of reducing vibration.
  • the effective value of vibration acceleration is reduced by 1 ⁇ 2m/s 2
  • the effective value of vibration speed is reduced by 3 ⁇ 5mm/s
  • the effective value of vibration displacement is reduced by 13 ⁇ 33 ⁇ m.
  • the gap between the motor bracket (4) and the magnetic steel (5) refers to one-half of the difference between the inner diameter of the motor bracket and the outer diameter of the magnetic steel.
  • the magnetic steel (5) may also contain a biocompatible material such as a titanium alloy, a polymer material, or the like.
  • the motor bracket is a layer structure which is coated on the inner diameter surface of the stator coil (3), and may be any insulating material or combination of insulating materials, or may be a film structure, a plating layer, a spray paint or the like.
  • the thickness of the magnetic steel (5) ranges from 1.5 mm to 3.5 mm, preferably between 2.0 mm and 3.0 mm, more preferably between 2.3 mm and 2.8 mm, and the blood pump involved in CN 201208423Y Compared with the structure (removing the bearing), the rotation speed can be increased by about 2000 rpm, and the current can be reduced and the power consumption can be reduced.
  • FIG. 1 is a schematic structural view (cross-sectional view) of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention
  • FIG. 2 is a schematic structural view of a slurry shaft integrated tandem blade according to a first embodiment of the present invention
  • FIG. 3 is a schematic view showing a blade cut surface of a slurry shaft integrated tandem blade according to a first embodiment of the present invention
  • FIG. 4 is a schematic radial cross-sectional view showing a structure of a stator and a rotor in a first embodiment of the present invention
  • FIG. 5 is a schematic structural view (cross-sectional view) of an initial state of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention
  • FIG. 6 is a schematic structural view (cross-sectional view) of a suspension state of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention
  • FIG. 7 is a schematic structural view of an implantable self-suspended shaft blood flow pump in a first embodiment of the present invention. (profile view).
  • a first embodiment of the invention relates to an implantable self-suspended shaft blood flow pump.
  • the implantable self-suspended shaft blood pump comprises: a stator and a rotor, wherein the stator comprises: a stator core (2), a stator coil (3) and a motor bracket (4); and the rotor comprises: a magnetic steel containing a magnetic material (5) ) and built-in paddles (8);
  • the radial direction from the inside to the outside is: built-in paddle (8), magnetic steel (5), motor bracket (4), stator coil (3) and stator core (2) .
  • the inner envelope of the cross section of the motor bracket (4) is circular;
  • the magnetic steel (5) has an axial central hole, and the outer envelope of the cross section of the magnetic steel (5) is circular;
  • stator and the rotor are not directly or indirectly connected by bearings; wherein the indirect connections include magnetic levitation and the like.
  • the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, and D is the inner diameter of the cross section of the magnetic steel (5).
  • the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.0042D to 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5).
  • the outer diameter, inner diameter and length range (mm) of the stator core according to the present invention can be appropriately adjusted according to the design of the present invention. Among them, the outer diameter, inner diameter and length range of the stator core (mm) ( ⁇ 10.5-48.6) ⁇ ( ⁇ 8.4-40.6) ⁇ (11.5-100.0); outer diameter, inner diameter and length range (mm) of the stator coil: ( ⁇ 8.4-40.6) ⁇ ( ⁇ 7.5-35.5) ⁇ (12.5 -102.5).
  • the outer diameter, inner diameter and length range (mm) of the stator core ( ⁇ 14.5-37.7) ⁇ ( ⁇ 11.4-29.6) ⁇ (11.5-30.0); outer diameter, inner diameter and length range (mm) of the stator coil :( ⁇ 11.4-29.6) ⁇ ( ⁇ 10.3-26.6) ⁇ (12.5-32.5). More preferably, the outer diameter, the inner diameter and the length range (mm) of the stator core are: ( ⁇ 20.3-37.7) ⁇ ( ⁇ 15.9-29.6) ⁇ (16.1-30.0), the outer diameter, the inner diameter and the length range of the stator coil ( Mm) can be ( ⁇ 15.9-29.6) ⁇ ( ⁇ 14.3-26.6) ⁇ (17.5-32.5).
  • FIG. 1 is a schematic structural view (cross-sectional view) of a preferred implantable self-suspended axial blood pump.
  • the implantable self-suspended shaft blood pump includes a stator and a rotor, wherein the stator includes a stator core (2), a stator coil (3), and a motor bracket (4).
  • the rotor includes: a magnetic ring magnet (5) having a cylindrical inner wall and a built-in paddle (8).
  • the magnetic steel (5) containing a magnetic material may further contain other materials as long as the permanent magnets are contained therein.
  • stator and the rotor are not directly or indirectly connected by bearings.
  • the indirect connection includes magnetic levitation and the like.
  • Bearings in various embodiments of the present invention include directly coupled bearings, as well as bearings that are not directly connected, such as magnetic bearings.
  • the stator coil (3) is inside the stator core (2).
  • the stator coil (3) is used to generate an alternating magnetic field that drives the rotation of the magnetic steel (5) after energization.
  • the stator is a hollow cylindrical structure. Because of the existence of the stator, the magnetic steel (5) made of permanent magnet material can be firmly attracted to the middle portion of the stator by the action of the magnetic force, and is not generated by the rotation. The reaction forces the rotor out of the middle of the stator.
  • the stator coil (3) uses a hollow cup winding.
  • a motor bracket (4) is fixed on the inner wall of the stator, and the motor bracket (4) has a hollow inner wall in which the rotor is placed.
  • the inner envelope of the cross section of the motor bracket (4) is circular; the magnetic steel (5) has an axial central hole, and the outer envelope of the cross section of the magnetic steel (5) is circular.
  • the hollow inner wall of the motor bracket (4) may be a regular cylindrical shape, an irregular cylindrical shape or a conical shape, or the like, as long as the inner envelope of the cross section of the motor bracket (4) is circular. can.
  • the outer wall of the magnetic steel (5) may be a regular cylindrical shape, an irregular cylindrical shape or a conical shape, or the like, as long as the outer envelope of the cross section of the magnetic steel (5) is circular.
  • the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, and D is the inner diameter of the cross section of the magnetic steel (5).
  • the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.0042D to 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5).
  • the thickness of the magnetic steel (5) ranges from 1.5 mm to 3.5 mm, preferably between 2.0 mm and 3.0 mm, more preferably between 2.3 mm and 2.8 mm. More preferably, the thickness is 2.8 mm, the rotation speed can be increased by about 2000 rpm, and the current can be reduced by 0.1 A, compared with the blood pump structure (removing the bearing) of CN 201208423Y.
  • the stator coil (3) adopts a hollow cup winding, which not only solves the problem of difficulty in lowering the stator of the small size, but also has no cogging in the stator core, completely eliminating the inherent rotational fluctuation caused by the tooth harmonic magnetic field.
  • stator coil (3) is also Instead of a hollow cup winding, other coil forms can be used.
  • the stator adopts a two-phase conduction, three-phase six-state conduction mode.
  • the two-phase conduction and three-phase six-state conduction mode not only improves the utilization of the winding, reduces the volume and weight, but also reduces the magnetic state angle and reduces the rotational fluctuation.
  • stator may also employ other conductive modes, and is not limited to only two-phase conduction, three-phase six-state conductive modes.
  • a motor housing (1) is also attached to the outside of the stator.
  • the utility model further comprises: an outlet right-handed stator (7), the outlet right-handed stator (7) is placed at the blood outlet end of the implantable self-suspended shaft blood pump, and is fixed with the motor bracket (4), Adjust the direction of blood outflow to further reduce rotational fluctuations.
  • the central axis of the magnetic steel (5) is parallel to the central axis of the stator coil (3).
  • the magnetic steel (5) is a cylindrical magnetic ring made of a neodymium iron boron permanent magnet material and radially magnetized and a pair of poles.
  • Magnetic steel (5) adopts NdFeB permanent magnet material with high residual magnetic induction intensity, and adopts radial magnetization and a pair of pole cylindrical magnetic ring column steel, which can be under the large electromagnetic air gap of hollow cup winding. It can still produce a strong air gap magnetic field, which reduces the volume and weight of the motor.
  • the one-pole integral cylindrical magnetic steel is more likely to ensure uniform mass, reduce the dynamic imbalance under high-speed motion, and because it does not exist.
  • the single-sided magnetic pulling force makes the operation smooth and improves the comfort of use.
  • a position sensor that determines the relative position between the stator and the rotor is not included in the blood pump.
  • the magnetic steel (5) has an axial central hole in which the built-in paddle (8) is placed, and the blade tip of the built-in paddle (8) is in close contact with or fixed to the inner wall of the central hole.
  • the inner bore of the magnetic steel (5) constitutes the main flow of blood flow.
  • the main channel in the inner hole of the magnetic steel (5) has no other obstructions, so the flow path is unobstructed. Xu Da blood flow smoothly passed.
  • it also includes a paddle shaft (10), and/or an external paddle (9).
  • the outer paddle (9) is larger than the inner paddle (8), and the outer paddle (9) is adjacent to the blood outlet end of the implantable self-suspended shaft blood pump, and is placed outside the central hole of the magnetic steel (5).
  • the built-in paddle (8) constitutes a pulp shaft-integrated tandem blade (6).
  • the outer paddle (9) and the built-in paddle (8) are integrally connected in series to the paddle shaft (10).
  • the two can also be directly connected without using a paddle shaft, as shown in FIG.
  • the rotor is designed in the form of a tandem blade, and a tandem structure in which the built-in paddle (8) is in front and the outer paddle (9) is behind is used.
  • the diameter of the rotor blade is limited, and the flow path is further divided into a main flow path and a branch flow path.
  • the concept of a tandem propeller in a marine propeller special propeller is adopted, and the blood pump is used.
  • the rotor is designed in the form of a tandem blade.
  • the so-called tandem blade refers to the installation of different sizes of blades on the same shaft and rotates at the same speed. This type of tandem blade is especially suitable for the narrow flow path of the implanted blood pump and the diameter of the rotor is limited. happening.
  • the rotor may not be a tandem blade, but other forms of blades, such as continuous blades, built-in.
  • the paddles and the outer blades can be connected to each other without a paddle shaft or the like.
  • the blade section of the built-in blade (8) and the external blade (9) is in the form of a wing-shaped blade of a marine ducted propeller.
  • the blade cut surface of the built-in blade (8) and the external blade (9) adopts the airfoil-shaped blade cut surface of the marine duct propeller.
  • a positive pressure appears on the leaf cut surface leaf.
  • Negative pressure occurs on the back of the cut leaf, and the pressure difference between the leaf surface and the leaf back can increase the efficiency of the blood pump and increase the pressure head.
  • the blade sections of the inner blade (8) and the outer blade (9) may also be shaped without the airfoil blade of the marine conduit propeller.
  • other forms may be used, for example, in the form of a flat leaf cut of a general pump.
  • the pump body rotor employs a wing-shaped blade section and large and small tandem rotors, particularly large and small tandem rotor blades.
  • the data shows that at a speed of 7500 rpm to 8000 rpm and a pressure of 90 mmHg to 100 mmHg, the flow rate of the large and small rotor blades is 2 liters/minute larger than that of the single small rotor blade.
  • 2 is a schematic view showing the structure of the slurry shaft integrated tandem blade.
  • Fig. 3 is a schematic view showing the blade cut surface of the slurry shaft integrated tandem blade and its force.
  • the slurry shaft integrated tandem blade (6) forms a mainstream flow (11) and (12) of blood flow between the inner wall of the motor bracket (4) and the inner hole of the magnetic steel (5); the magnetic steel (5)
  • the outer wall and the inner wall of the motor bracket (4) constitute branch passages (13) and (14) for blood flow.
  • the built-in paddle (8) in front and the outer paddle (9) in the rear structure it can ensure that blood enters the flow channel from the blood flow inlet (15), and then the built-in tandem blade (8) rotates the blade first.
  • the role is to ensure that most of the blood passes through the main channel, and the trace blood is passed through the tip of the outer blade (9) disposed behind, so that the blood can be smoothly split in the main and branch channels, and the flow is smooth. Pass, no congestion thrombosis.
  • the implantable self-suspended shaft blood pump is used for the implantable ventricular assist device, there is a high requirement for the structural sealing.
  • a conventional brushless DC motor position sensor is used, the sensor stator Hall element is used.
  • the present invention uses a circuit to realize the function of identifying the rotor position and self-starting, and functions as a position sensor, which can cancel the conventional brushless The necessary position sensor for the DC motor, so that Reducing the difficulty of sealing, improving reliability, simplifying the structure and reducing the volume.
  • the rotor comprises a hollow cylindrical magnetic steel and a built-in paddle fixed therein, the rotor is directly placed in the middle of the stator, and the stator and the rotor are not directly or indirectly connected by bearings, and the rotor is free from contact with the inner wall of the stator when rotating, Self-suspended. Because no bearing or magnetic levitation control is used, the blood pump is smaller in size, lighter in weight, does not stop rotating due to mechanical failure of the bearing, is more reliable, and avoids the formation of a thrombus at the bearing position.
  • FIG. 4 is a schematic radial cross-sectional view of the stator and rotor structure.
  • stator coil (3) When the stator coil (3) is energized, an air gap between the inner wall of the stator coil (3) and the outer wall of the magnetic steel (5) generates a rotating magnetic field to drive the magnetic steel (5) to rotate, due to the centrifugal force of the magnetic steel, magnetic
  • the steel instantaneously disengages from the initial state of contact with the stator coil, and lies on the inner wall of the motor bracket (4), and the medium is an incompressible fluid, and the magnetic steel quickly reaches a state of suspension rotation coaxial with the stator coil, and drives the magnetic steel.
  • the integrated paddle shaft integrated serial blade (6) rotates together, and blood is sucked from the blood flow inlet (15) of the pump body and flows out from the outlet.
  • FIG. 5 is a schematic structural view (cross-sectional view) of the initial state of the implantable self-suspended axial blood pump
  • FIG. 6 is a schematic structural view (cross-sectional view) of the floating state of the implantable self-suspended axial blood pump, wherein the number is 20 Indicates the outer diameter of the magnetic steel, and 21 indicates the inner diameter of the motor bracket.
  • the implantable self-suspended axial blood pump has the advantages of simple structure, small volume, light weight, blood bifurcation by the main channel and the branch channel, smooth flow, no congestion and thrombus, no bearing friction, balanced operation, comfortable use, and blood pump efficiency. High, hemolysis and anti-thrombosis properties, fully suitable for use as an implantable ventricular assist device. Based on the above principles, the inventors have developed prototypes of various sizes, all of which can operate normally.
  • the outer diameter, inner diameter and length of the stator core may be (mm): 10.5 ⁇ 8.7 ⁇ 11.5; 14.5 ⁇ 12.4 ⁇ 15.5; 20.5 ⁇ 17.7 ⁇ 30; 29 ⁇ 22.8 ⁇ 33; 35.5 ⁇ 29.6 ⁇ 60;
  • the outer diameter, inner diameter and length of the motor coil may be (mm): 8.7 x 7.5 x 12.5; 12.4 x 10.3 x 17.5; 17.7 x 12.6 x 32.5; 22.8 x 20.5 x 38; 29.6 x 26.6 x 65.5.
  • the prototype can be started and stopped in all directions, and can operate normally under the impact of a certain external force (impact or sway, etc.).
  • the inventor performed a fatigue test on the implantable self-suspended shaft blood pump and recorded it in real time by a computer, wherein the prototype can also operate normally in the case of intermittent start and stop.
  • the self-suspended shaft blood pump body is optimized, compact in structure, has few main channel nodes, and has good axial sealing performance.
  • the pump body can be significantly shortened.
  • the outer diameter, inner diameter and length range (mm) of the motor core according to the present invention can be appropriately adjusted according to the design of the present invention.
  • the rotational speed of the blood pump ranges from 4000 rpm to 8000 rpm, and the corresponding flow rate varies from 2 to 6 L/min under the same pressure (100 mmHg).
  • the rotation speed is 8000 rpm, the corresponding flow rate is about 6 L/min.
  • the speed can be further increased, and the relevant indicators such as the corresponding flow rate also rise.
  • the axial flow self-suspending pump of the present invention can continuously rotate for one year and four months or more.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
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Abstract

An implanted self-suspended axial flow blood pump, comprising a stator and a rotor; the stator comprises a stator iron core (2), a stator coil (3) and a motor bracket (4); the rotor comprises a magnetic steel (5) comprising magnetic material and built-in blades (8); the built-in blades (8), the magnetic steel (5), the motor bracket (4), the stator coil (3) and the stator iron core (2) are sequentially disposed in a radial direction from inward to outward in the cross section of the blood pump; the stator and the rotor are connected without bearings; the rotor is in a self-suspended state when rotating; in the structure of the blood pump, the built-in blades (8) are disposed in the front, and the blades (9) to be externally disposed are arranged in the rear, and the tangent plane of the blades take the form of the tangent plane of awing-shaped blade of a marine duct propeller, such that blood is ensured to smoothly bifurcate and flow in main and branch vessels.

Description

植入式自悬浮轴流血泵Implantable self-suspended shaft blood pump 技术领域Technical field
本发明涉及医疗器械技术领域,特别涉及一种植入式心室辅助装置。The present invention relates to the field of medical device technology, and in particular to an implantable ventricular assist device.
背景技术Background technique
心力衰竭(心衰)是心血管病人最常见的诊断,也是医疗费用最高的疾病,国际上已经将心衰作为本世纪需要解决的一项重要课题。由于供体的缺乏,大约30%准备接受心脏移植的病人在等待供心过程中死于心功能恶化。Heart failure (heart failure) is the most common diagnosis of cardiovascular patients, and it is also the disease with the highest medical cost. Internationally, heart failure has been an important issue to be solved in this century. Due to the lack of donors, approximately 30% of patients preparing for heart transplantation die of cardiac function deterioration while waiting for heart delivery.
心室辅助装置(Ventricular Assist Devices,简称“VAD”)的出现和发展,使得心衰的治疗有了新的途经,从1981年开始,美国国立卫生研究院(National Institutes of Health,简称“NIH”)发起RFPs(a Request For Proposals,简称“征求建议书”)计划,用于发展“用于长期心脏支持的可植入式能使病人自由移动、电动能源的心室辅助装置”。到目前为止,共投入超过400亿美元的资金以支持心室辅助装置的研发。2006年欧洲心衰指南已将心室辅助装置作为心衰治疗的方法之一。经过多年的研究,目前,国际上已经有数种产品应用于临床,主要用于心脏移植的过渡、心功能的恢复甚至永久性替代治疗。但是,进口产品价格昂贵,心室辅助装置的国产化研制迫在眉睫。The emergence and development of Ventricular Assist Devices (VAD) has made new treatments for heart failure. Since 1981, the National Institutes of Health (NIH) Initiate RFPs (a Request For Proposals) program for the development of "implantable ventricular assist devices that enable patients to move freely and use electric energy for long-term cardiac support." To date, more than $40 billion has been invested to support the development of ventricular assist devices. The 2006 European Heart Failure Guidelines have used ventricular assist devices as one of the methods of heart failure treatment. After years of research, there are currently several products in the world for clinical use, mainly for the transition of heart transplantation, recovery of cardiac function and even permanent replacement therapy. However, imported products are expensive, and the localization of ventricular assist devices is extremely urgent.
目前,一般心室辅助装置的泵系统,以国产VZ-IIA型血泵和Berlin Heart Incor 1为例,其电机磁钢转子、血泵转子和轴承或磁悬浮控制体同置于血液流道中,这样不但增加了整个泵机系统的体积和重量,而且在血液流道中放置转子磁钢和磁悬浮控制体也大大减小了血液流量,而且电机定子和转子间的气隙增加,所需功率也增大。 At present, the pump system of the general ventricular assist device uses the domestic VZ-IIA blood pump and the Berlin Heart Incor 1 as an example, and the motor magnetic steel rotor, the blood pump rotor and the bearing or the magnetic levitation control body are placed in the blood flow channel, so that not only The volume and weight of the entire pump system is increased, and the placement of the rotor magnet and the magnetic levitation control body in the blood flow path also greatly reduces the blood flow, and the air gap between the stator and the rotor of the motor increases, and the required power also increases.
同时,市场上现有的植入式有轴承血泵,轴承易磨损,易震动,使用寿命短,可靠性低,容易形成血栓。另一方面,磁悬浮血泵的磁悬浮控制系统结构复杂,体积大,重量重,并且对控制运转平衡、震动幅度等参数的要求高。因此,心室辅助装置的临床应用不但要求其体积小,重量轻,不易血栓,而且还要求装置运转必须平衡、震动小、噪声低,以提高病人使用时的舒适度。At the same time, the existing implantable bearing blood pump on the market, the bearing is easy to wear, easy to vibrate, short service life, low reliability, and easy to form a thrombus. On the other hand, the magnetic levitation control system of the magnetic levitation blood pump has a complicated structure, a large volume, a heavy weight, and high requirements on parameters such as control operation balance and vibration amplitude. Therefore, the clinical application of the ventricular assist device not only requires small size, light weight, and is not easy to thrombosis, but also requires the device to operate in balance, low vibration, and low noise, so as to improve the comfort of the patient during use.
发明内容Summary of the invention
本发明的目的在于提供一种植入式自悬浮轴流血泵,血泵的体积更小,重量更轻,不会因为轴承的机械故障而停止转动,可靠性更高,而且避免了在轴承位置形成血栓。The object of the present invention is to provide an implantable self-suspended axial blood pump, which is smaller in volume, lighter in weight, does not stop rotating due to mechanical failure of the bearing, has higher reliability, and avoids the position at the bearing. Form a thrombus.
为解决上述技术问题,本发明的实施方式公开了一种植入式自悬浮轴流血泵,包括:定子和转子,其中定子包括:定子铁芯(2)、定子线圈(3)和电机支架(4);转子包括:含有磁性材料的磁钢(5)和内置桨叶(8);In order to solve the above technical problem, an embodiment of the present invention discloses an implantable self-suspended shaft blood flow pump comprising: a stator and a rotor, wherein the stator includes: a stator core (2), a stator coil (3), and a motor bracket ( 4); the rotor includes: a magnetic steel (5) containing a magnetic material and a built-in paddle (8);
在该血泵的横截面中,沿径向由内到外依次为:内置桨叶(8)、磁钢(5)、电机支架(4)、定子线圈(3)和定子铁芯(2);In the cross section of the blood pump, the radial direction from the inside to the outside is: built-in paddle (8), magnetic steel (5), motor bracket (4), stator coil (3) and stator core (2) ;
定子和转子之间不以轴承连接。There is no bearing connection between the stator and the rotor.
本发明实施方式与现有技术相比,主要区别及其效果在于:Compared with the prior art, the main differences and effects of the embodiments of the present invention are as follows:
转子包括空心的环形磁钢和固定在其中的内置桨叶,转子直接置于定子中间,定子和转子之间不以轴承直接或间接地连接,转子在转动时自行脱离与定子内壁的接触,呈自悬浮状态。因为没有使用轴承或磁悬浮控制系统,所以血泵的体积更小,重量更轻。The rotor comprises a hollow annular magnetic steel and a built-in paddle fixed therein, the rotor is directly placed in the middle of the stator, and the stator and the rotor are not directly or indirectly connected by bearings, and the rotor is self-detached from the contact with the inner wall of the stator when rotating. Self-suspending state. Because there is no bearing or magnetic suspension control system, the blood pump is smaller and lighter.
进一步地,本发明不会因为轴承的机械故障而停止转动,可靠性更高,而且避免了在轴承位置形成血栓。同时又不需要复杂的磁悬浮控制系统,所 以血泵的成本更低,可靠性更好。Further, the present invention does not stop the rotation due to mechanical failure of the bearing, is more reliable, and avoids the formation of a thrombus at the bearing position. At the same time, no complicated magnetic levitation control system is needed. The cost of the blood pump is lower and the reliability is better.
进一步地,定子线圈(3)采用空心杯绕组,不但解决了小尺寸的定子下线困难的问题,而且定子铁芯不再有齿槽,彻底消除了齿谐波磁场带来的本质上的转动波动。Further, the stator coil (3) adopts a hollow cup winding, which not only solves the problem that the small-sized stator is difficult to go offline, but also has no cogging in the stator core, completely eliminating the essential rotation caused by the tooth harmonic magnetic field. fluctuation.
进一步地,采用内置桨叶(8)在前,外置桨叶(9)在后的结构,可以保证血液在进入流道时,先受到内置桨叶(8)转动叶片的作用,保证绝大部分血液从主流道通过,而微量血液则借助于设置在后面的外置桨叶(9)的叶梢部分作用通过,这样可以保证血液在主、支流道内顺利分叉,流畅通过,不产生拥塞血栓现象。Further, the structure with the built-in paddle (8) in front and the outer paddle (9) in the back can ensure that the blood enters the flow channel first, and is firstly subjected to the rotation of the blade by the built-in paddle (8) to ensure maximum Part of the blood passes through the main channel, and the trace blood passes through the tip of the outer blade (9) disposed at the back, which ensures that the blood smoothly branches in the main and branch channels, smoothly passes, and does not cause congestion. Thrombosis.
进一步地,内置桨叶(8)和外置桨叶(9)的叶切面采用船用导管螺旋桨的机翼形叶片切面形式,当血液流过机翼形叶切面时,叶切面叶面上出现正压,叶切面叶背上出现负压,叶面和叶背的压力差可以提高血泵效率,增大压头。Further, the leaf cut surface of the built-in blade (8) and the outer blade (9) adopts a blade-shaped blade shape of a marine ducted propeller, and when blood flows through the airfoil-shaped cut surface, a positive surface appears on the leaf cut surface. Pressure, negative pressure on the leaf back of the leaf cut surface, the pressure difference between the leaf surface and the leaf back can improve the efficiency of the blood pump and increase the pressure head.
进一步地,采用二相导通、三相六状态的导电模式,不但提高了绕组的利用率,缩小了体积和重量,而且减小了磁状态角,减小了转动波动。Further, the two-phase conduction, three-phase six-state conduction mode not only improves the utilization of the winding, reduces the volume and weight, but also reduces the magnetic state angle and reduces the rotational fluctuation.
进一步地,出口右旋定子(7)与电机支架(4)固定在一起,起到调整血流流出方向的作用。Further, the outlet right-handed stator (7) is fixed to the motor bracket (4) to adjust the direction of blood flow outflow.
进一步地,采用电路实现可鉴别转子位置和自启动的功能,起到了位置传感器的作用,可以取消常规的位置传感器,这样既减小密封的难度,提高了可靠性,又简化了结构,缩小了体积。Further, the circuit realizes the function of identifying the position of the rotor and the self-starting function, and functions as a position sensor, which can cancel the conventional position sensor, thereby reducing the difficulty of sealing, improving the reliability, simplifying the structure, and reducing the structure. volume.
进一步地,电机支架(4)和磁钢(5)之间的间隙范围在0.003D~0.019D之间,优选在0.0042D~0.0048D之间,D为磁钢(5)横截面的内直径,D的范围优选在5~32mm之间,更优选的在6.7~25mm,对减小震动有最佳效果。与CN 201208423Y所涉及的血泵结构(去除轴承)相比,其震动加速度有效值降低1~2m/s2,震动速度有效值降低3~5mm/s,震动位移有 效值降低13~33μm。电机支架(4)和磁钢(5)之间的间隙指的是电机支架内径和磁钢外径差值的二分之一。Further, the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, preferably between 0.0042D and 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5). The range of D is preferably between 5 and 32 mm, more preferably between 6.7 and 25 mm, which has the best effect of reducing vibration. Compared with the blood pump structure (removing bearing) involved in CN 201208423Y, the effective value of vibration acceleration is reduced by 1~2m/s 2 , the effective value of vibration speed is reduced by 3~5mm/s, and the effective value of vibration displacement is reduced by 13~33μm. The gap between the motor bracket (4) and the magnetic steel (5) refers to one-half of the difference between the inner diameter of the motor bracket and the outer diameter of the magnetic steel.
另外,含有磁性材料的磁钢(5)中,还可以包含其他的材料,只要其中内含了永磁体即可。磁钢(5)也可以包含生物相容性材料,如钛合金、高分子材料等。Further, in the magnetic steel (5) containing a magnetic material, other materials may be contained as long as the permanent magnets are contained therein. The magnetic steel (5) may also contain a biocompatible material such as a titanium alloy, a polymer material, or the like.
电机支架是包覆在定子线圈(3)内径表面的一层结构,可以为任意绝缘材料或组合绝缘材料,也可以是薄膜结构、镀层、喷漆等。The motor bracket is a layer structure which is coated on the inner diameter surface of the stator coil (3), and may be any insulating material or combination of insulating materials, or may be a film structure, a plating layer, a spray paint or the like.
进一步地,磁钢(5)的厚度范围在1.5mm~3.5mm之间,优选在2.0mm~3.0mm之间,更优选的在2.3mm~2.8mm之间,与CN 201208423Y所涉及的血泵结构(去除轴承)相比,转速可提高2000转/分(rpm)左右,同时可以降低电流,减小功耗。Further, the thickness of the magnetic steel (5) ranges from 1.5 mm to 3.5 mm, preferably between 2.0 mm and 3.0 mm, more preferably between 2.3 mm and 2.8 mm, and the blood pump involved in CN 201208423Y Compared with the structure (removing the bearing), the rotation speed can be increased by about 2000 rpm, and the current can be reduced and the power consumption can be reduced.
附图说明DRAWINGS
图1是本发明第一实施方式中一种植入式自悬浮轴流血泵的结构示意图(剖面图);1 is a schematic structural view (cross-sectional view) of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention;
图2是本发明第一实施方式中一种浆轴一体化串列桨叶的结构示意图;2 is a schematic structural view of a slurry shaft integrated tandem blade according to a first embodiment of the present invention;
图3是本发明第一实施方式中一种浆轴一体化串列桨叶的叶切面及其受力示意图;3 is a schematic view showing a blade cut surface of a slurry shaft integrated tandem blade according to a first embodiment of the present invention;
图4是本发明第一实施方式中一种定子、转子结构的径向剖面示意图;4 is a schematic radial cross-sectional view showing a structure of a stator and a rotor in a first embodiment of the present invention;
图5是本发明第一实施方式中一种植入式自悬浮轴流血泵的初始状态结构示意图(剖面图);5 is a schematic structural view (cross-sectional view) of an initial state of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention;
图6是本发明第一实施方式中一种植入式自悬浮轴流血泵的悬浮状态结构示意图(剖面图);6 is a schematic structural view (cross-sectional view) of a suspension state of an implantable self-suspended shaft blood flow pump according to a first embodiment of the present invention;
图7是本发明第一实施方式中一种植入式自悬浮轴流血泵的结构示意图 (剖面图)。7 is a schematic structural view of an implantable self-suspended shaft blood flow pump in a first embodiment of the present invention; (profile view).
具体实施方式detailed description
在以下的叙述中,为了使读者更好地理解本申请而提出了许多技术细节。但是,本领域的普通技术人员可以理解,即使没有这些技术细节和基于以下各实施方式的种种变化和修改,也可以实现本申请各权利要求所要求保护的技术方案。In the following description, numerous technical details are set forth in order to provide the reader with a better understanding of the present application. However, those skilled in the art can understand that the technical solutions claimed in the claims of the present application can be implemented without these technical details and various changes and modifications based on the following embodiments.
为使本发明的目的、技术方案和优点更加清楚,下面将结合附图对本发明的实施方式作进一步地详细描述。The embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.
本发明第一实施方式涉及一种植入式自悬浮轴流血泵。该植入式自悬浮轴流血泵包括:定子和转子,其中定子包括:定子铁芯(2)、定子线圈(3)和电机支架(4);转子包括:含有磁性材料的磁钢(5)和内置桨叶(8);A first embodiment of the invention relates to an implantable self-suspended shaft blood flow pump. The implantable self-suspended shaft blood pump comprises: a stator and a rotor, wherein the stator comprises: a stator core (2), a stator coil (3) and a motor bracket (4); and the rotor comprises: a magnetic steel containing a magnetic material (5) ) and built-in paddles (8);
在该血泵的横截面中,沿径向由内到外依次为:内置桨叶(8)、磁钢(5)、电机支架(4)、定子线圈(3)和定子铁芯(2)。In the cross section of the blood pump, the radial direction from the inside to the outside is: built-in paddle (8), magnetic steel (5), motor bracket (4), stator coil (3) and stator core (2) .
定子和转子之间不以轴承连接。There is no bearing connection between the stator and the rotor.
电机支架(4)横截面的内包络线为圆形;磁钢(5)中有一个轴向的中心孔洞,磁钢(5)横截面的外包络线为圆形;The inner envelope of the cross section of the motor bracket (4) is circular; the magnetic steel (5) has an axial central hole, and the outer envelope of the cross section of the magnetic steel (5) is circular;
定子和转子之间不以轴承直接或间接地连接;其中间接连接包括磁悬浮等。The stator and the rotor are not directly or indirectly connected by bearings; wherein the indirect connections include magnetic levitation and the like.
电机支架(4)和磁钢(5)之间的间隙范围在0.003D~0.019D之间,D为磁钢(5)横截面的内直径。The gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, and D is the inner diameter of the cross section of the magnetic steel (5).
更进一步地,优选地,电机支架(4)和磁钢(5)之间的间隙范围在0.0042D~0.0048D之间,D为磁钢(5)横截面的内直径。Further, preferably, the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.0042D to 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5).
本发明所述的定子铁芯的外径、内径及长度范围(mm)可以根据本发明的设计方案适当调整。其中,定子铁芯的外径、内径及长度范围(mm) (¢10.5-48.6)×(¢8.4-40.6)×(11.5-100.0);定子线圈的外径、内径及长度范围(mm):(¢8.4-40.6)×(¢7.5-35.5)×(12.5-102.5)。优选地,定子铁芯的外径、内径及长度范围(mm)(¢14.5-37.7)×(¢11.4-29.6)×(11.5-30.0);定子线圈的外径、内径及长度范围(mm):(¢11.4-29.6)×(¢10.3-26.6)×(12.5-32.5)。更优选地,定子铁芯的外径、内径及长度范围(mm):(¢20.3-37.7)×(¢15.9-29.6)×(16.1-30.0),定子线圈的外径、内径及长度范围(mm)可以是(¢15.9-29.6)×(¢14.3-26.6)×(17.5-32.5)。The outer diameter, inner diameter and length range (mm) of the stator core according to the present invention can be appropriately adjusted according to the design of the present invention. Among them, the outer diameter, inner diameter and length range of the stator core (mm) (¢10.5-48.6)×(¢8.4-40.6)×(11.5-100.0); outer diameter, inner diameter and length range (mm) of the stator coil: (¢8.4-40.6)×(¢7.5-35.5)×(12.5 -102.5). Preferably, the outer diameter, inner diameter and length range (mm) of the stator core (¢14.5-37.7)×(¢11.4-29.6)×(11.5-30.0); outer diameter, inner diameter and length range (mm) of the stator coil :(¢11.4-29.6)×(¢10.3-26.6)×(12.5-32.5). More preferably, the outer diameter, the inner diameter and the length range (mm) of the stator core are: (¢20.3-37.7)×(¢15.9-29.6)×(16.1-30.0), the outer diameter, the inner diameter and the length range of the stator coil ( Mm) can be (¢15.9-29.6)×(¢14.3-26.6)×(17.5-32.5).
图1是一种优选的植入式自悬浮轴流血泵的结构示意图(剖面图)。1 is a schematic structural view (cross-sectional view) of a preferred implantable self-suspended axial blood pump.
具体地说,如图1所示,该植入式自悬浮轴流血泵包括:定子和转子,其中定子包括:定子铁芯(2)、定子线圈(3)和电机支架(4)。转子包括:含有磁性材料的内侧壁为圆柱形的磁环磁钢(5)和内置桨叶(8)。Specifically, as shown in FIG. 1, the implantable self-suspended shaft blood pump includes a stator and a rotor, wherein the stator includes a stator core (2), a stator coil (3), and a motor bracket (4). The rotor includes: a magnetic ring magnet (5) having a cylindrical inner wall and a built-in paddle (8).
另外,具体地说,含有磁性材料的磁钢(5)中,还可以包含其他的材料,只要其中内含了永磁体即可。Further, specifically, the magnetic steel (5) containing a magnetic material may further contain other materials as long as the permanent magnets are contained therein.
在本实施方式中,优选地,定子和转子之间不以轴承直接或间接地连接。其中,间接连接包括磁悬浮等。In the present embodiment, preferably, the stator and the rotor are not directly or indirectly connected by bearings. Among them, the indirect connection includes magnetic levitation and the like.
本发明各实施方式中的轴承包括直接连接的轴承,也包括不直接连接的轴承,如磁悬浮轴承。Bearings in various embodiments of the present invention include directly coupled bearings, as well as bearings that are not directly connected, such as magnetic bearings.
定子线圈(3)在定子铁芯(2)内侧。定子线圈(3)用于在通电后产生驱动磁钢(5)旋转的交变磁场。The stator coil (3) is inside the stator core (2). The stator coil (3) is used to generate an alternating magnetic field that drives the rotation of the magnetic steel (5) after energization.
定子是一个中空筒状的结构,因为定子的存在,可以使由永磁材料制成的磁钢(5)依靠磁力的作用被牢牢地吸引在定子的中间部位,不会因为旋转时产生的反作用力而导致转子脱离定子中间部位。The stator is a hollow cylindrical structure. Because of the existence of the stator, the magnetic steel (5) made of permanent magnet material can be firmly attracted to the middle portion of the stator by the action of the magnetic force, and is not generated by the rotation. The reaction forces the rotor out of the middle of the stator.
定子线圈(3)采用空心杯绕组。 The stator coil (3) uses a hollow cup winding.
定子内壁上固定有电机支架(4),该电机支架(4)有一个中空内壁,转子置于该中空内壁之中。A motor bracket (4) is fixed on the inner wall of the stator, and the motor bracket (4) has a hollow inner wall in which the rotor is placed.
电机支架(4)横截面的内包络线为圆形;磁钢(5)中有一个轴向的中心孔洞,磁钢(5)横截面的外包络线为圆形。The inner envelope of the cross section of the motor bracket (4) is circular; the magnetic steel (5) has an axial central hole, and the outer envelope of the cross section of the magnetic steel (5) is circular.
具体地说,电机支架(4)的中空内壁可以是规则的圆柱形,也可以是不规则的圆柱形或圆锥形等等,只要电机支架(4)横截面的内包络线为圆形即可。Specifically, the hollow inner wall of the motor bracket (4) may be a regular cylindrical shape, an irregular cylindrical shape or a conical shape, or the like, as long as the inner envelope of the cross section of the motor bracket (4) is circular. can.
同样地,磁钢(5)的外壁可以是规则的圆柱形,也可以是不规则的圆柱形或圆锥形等等,只要磁钢(5)横截面的外包络线为圆形即可。Similarly, the outer wall of the magnetic steel (5) may be a regular cylindrical shape, an irregular cylindrical shape or a conical shape, or the like, as long as the outer envelope of the cross section of the magnetic steel (5) is circular.
电机支架(4)和磁钢(5)之间的间隙范围在0.003D~0.019D之间,D为磁钢(5)横截面的内直径。The gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, and D is the inner diameter of the cross section of the magnetic steel (5).
更进一步地,优选地,电机支架(4)和磁钢(5)之间的隙范围在0.0042D~0.0048D之间,D为磁钢(5)横截面的内直径。与CN 201208423Y所涉及的血泵结构(去除轴承)相比,其中震动加速度有效值降低1~2m/s2,震动速度有效值降低3~5mm/s,震动位移有效值降低13~33μm,转动稳定性大大提高。Further, preferably, the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.0042D to 0.0048D, and D is the inner diameter of the cross section of the magnetic steel (5). Compared with the blood pump structure (removing the bearing) involved in CN 201208423Y, the effective value of the vibration acceleration is reduced by 1~2m/s 2 , the effective value of the vibration speed is reduced by 3~5mm/s, and the effective value of the vibration displacement is reduced by 13~33μm. Stability is greatly improved.
磁钢(5)的厚度范围在1.5mm~3.5mm之间,优选在2.0mm~3.0mm之间,更优选的在2.3mm~2.8mm之间。与CN 201208423Y所涉及的血泵结构(去除轴承)相比,更优选厚度为2.8mm,转速可提高2000转/分(rpm)左右,电流可降低0.1A。The thickness of the magnetic steel (5) ranges from 1.5 mm to 3.5 mm, preferably between 2.0 mm and 3.0 mm, more preferably between 2.3 mm and 2.8 mm. More preferably, the thickness is 2.8 mm, the rotation speed can be increased by about 2000 rpm, and the current can be reduced by 0.1 A, compared with the blood pump structure (removing the bearing) of CN 201208423Y.
定子线圈(3)采用空心杯绕组,不但解决了小尺寸的定子下线困难的问题,而且定子铁芯不再有齿槽,彻底消除了齿谐波磁场带来的本质上的转动波动。The stator coil (3) adopts a hollow cup winding, which not only solves the problem of difficulty in lowering the stator of the small size, but also has no cogging in the stator core, completely eliminating the inherent rotational fluctuation caused by the tooth harmonic magnetic field.
此外,可以理解,在本发明的其它某些实施方式中,定子线圈(3)也 可以不采用空心杯绕组,而采用其它的线圈形式。Moreover, it will be appreciated that in other certain embodiments of the invention, the stator coil (3) is also Instead of a hollow cup winding, other coil forms can be used.
定子采用二相导通、三相六状态的导电模式。The stator adopts a two-phase conduction, three-phase six-state conduction mode.
采用二相导通、三相六状态的导电模式,不但提高了绕组的利用率,缩小了体积和重量,而且减小了磁状态角,减小了转动波动。The two-phase conduction and three-phase six-state conduction mode not only improves the utilization of the winding, reduces the volume and weight, but also reduces the magnetic state angle and reduces the rotational fluctuation.
此外,可以理解,在本发明的其它某些实施方式中,定子也可以采用其它的导电模式,而不仅仅限于二相导通、三相六状态的导电模式。Moreover, it will be appreciated that in other embodiments of the invention, the stator may also employ other conductive modes, and is not limited to only two-phase conduction, three-phase six-state conductive modes.
定子的外部还固定有电机外壳(1)。A motor housing (1) is also attached to the outside of the stator.
此外,还包括:出口右旋定子(7),该出口右旋定子(7)置于植入式自悬浮轴流血泵的血流出口端,与电机支架(4)固定在一起,起到调整血液流出方向作用,进一步减少转动波动。In addition, the utility model further comprises: an outlet right-handed stator (7), the outlet right-handed stator (7) is placed at the blood outlet end of the implantable self-suspended shaft blood pump, and is fixed with the motor bracket (4), Adjust the direction of blood outflow to further reduce rotational fluctuations.
磁钢(5)的中轴线平行于定子线圈(3)的中轴线。The central axis of the magnetic steel (5) is parallel to the central axis of the stator coil (3).
优选地,磁钢(5)是一个由铷铁硼永磁材料制成的、径向充磁和一对极的圆柱磁环。Preferably, the magnetic steel (5) is a cylindrical magnetic ring made of a neodymium iron boron permanent magnet material and radially magnetized and a pair of poles.
磁钢(5)采用具有剩磁感应强度高的铷铁硼永磁材料,且采用径向充磁、一对极的圆柱形磁环柱钢,可在空心杯绕组这种大的电磁气隙下,仍能产生较强的气隙磁场,从而缩小了电动机的体积和重量,一对极的整体圆柱形磁钢更易保证质量的均匀,减小了高速运动下的动不平衡,并且因为不存在单边磁拉力,所以运转平稳,提高了使用的舒适性。Magnetic steel (5) adopts NdFeB permanent magnet material with high residual magnetic induction intensity, and adopts radial magnetization and a pair of pole cylindrical magnetic ring column steel, which can be under the large electromagnetic air gap of hollow cup winding. It can still produce a strong air gap magnetic field, which reduces the volume and weight of the motor. The one-pole integral cylindrical magnetic steel is more likely to ensure uniform mass, reduce the dynamic imbalance under high-speed motion, and because it does not exist. The single-sided magnetic pulling force makes the operation smooth and improves the comfort of use.
此外,在该血泵中不包括确定定子和转子之间相对位置的位置传感器。Further, a position sensor that determines the relative position between the stator and the rotor is not included in the blood pump.
磁钢(5)中有一个轴向的中心孔洞,内置桨叶(8)置于该中心孔洞中,内置桨叶(8)的叶梢与该中心孔洞的内壁紧密接触或固定成一体。The magnetic steel (5) has an axial central hole in which the built-in paddle (8) is placed, and the blade tip of the built-in paddle (8) is in close contact with or fixed to the inner wall of the central hole.
磁钢(5)的内孔之间构成血液流动的主流道。The inner bore of the magnetic steel (5) constitutes the main flow of blood flow.
磁钢(5)内孔中的主流道,没有其他任何阻碍物,因此流道通畅,允 许大血流量顺畅通过。The main channel in the inner hole of the magnetic steel (5) has no other obstructions, so the flow path is unobstructed. Xu Da blood flow smoothly passed.
此外,还包括:桨轴(10),和/或外置桨叶(9)。In addition, it also includes a paddle shaft (10), and/or an external paddle (9).
外置桨叶(9)大于内置桨叶(8),外置桨叶(9)靠近植入式自悬浮轴流血泵的血流出口一端,置于磁钢(5)的中心孔洞的外部,与内置桨叶(8)构成浆轴一体化串列桨叶(6),优选地,外置桨叶(9)与内置桨叶(8)一体化串联在桨轴(10)上。此外,两者也可以不采用桨轴,直接连接,如图7所示。The outer paddle (9) is larger than the inner paddle (8), and the outer paddle (9) is adjacent to the blood outlet end of the implantable self-suspended shaft blood pump, and is placed outside the central hole of the magnetic steel (5). And the built-in paddle (8) constitutes a pulp shaft-integrated tandem blade (6). Preferably, the outer paddle (9) and the built-in paddle (8) are integrally connected in series to the paddle shaft (10). In addition, the two can also be directly connected without using a paddle shaft, as shown in FIG.
在本实施方式中,优选地,将转子设计为串列桨叶形式,采用内置桨叶(8)在前,外置桨叶(9)在后的串列结构。In the present embodiment, preferably, the rotor is designed in the form of a tandem blade, and a tandem structure in which the built-in paddle (8) is in front and the outer paddle (9) is behind is used.
有鉴于血泵内流道狭长,转子的叶片直径受到限制,且流道又分为主流道和支流道,本实施方式中采用了船用螺旋桨特种推进器中的串列螺旋桨概念,将血泵的转子设计为串列桨叶形式。所谓串列桨叶是指将不同大小的桨叶安装在同一根轴上,且按同一转速旋转,这类串列桨叶形式特别适用于植入式血泵流道狭长,转子直径受限制的情况。In view of the narrow flow path in the blood pump, the diameter of the rotor blade is limited, and the flow path is further divided into a main flow path and a branch flow path. In this embodiment, the concept of a tandem propeller in a marine propeller special propeller is adopted, and the blood pump is used. The rotor is designed in the form of a tandem blade. The so-called tandem blade refers to the installation of different sizes of blades on the same shaft and rotates at the same speed. This type of tandem blade is especially suitable for the narrow flow path of the implanted blood pump and the diameter of the rotor is limited. Happening.
当然,这只是本发明的一种优选的实施方式,在本发明的其它某些实施方式中,转子也可以不是串列桨叶,而是其它形式的桨叶,例如可以是连续桨叶,内置桨叶和外置桨叶可以相互连接,不采用桨轴等等。Of course, this is only a preferred embodiment of the present invention. In some other embodiments of the present invention, the rotor may not be a tandem blade, but other forms of blades, such as continuous blades, built-in. The paddles and the outer blades can be connected to each other without a paddle shaft or the like.
内置桨叶(8)和外置桨叶(9)的叶切面采用船用导管螺旋桨的机翼形叶片切面形式。The blade section of the built-in blade (8) and the external blade (9) is in the form of a wing-shaped blade of a marine ducted propeller.
内置桨叶(8)和外置桨叶(9)的叶切面采用船用导管螺旋桨的机翼形叶片切面形式,当血液流过机翼形叶切面时,叶切面叶面上出现正压,叶切面叶背上出现负压,叶面和叶背的压力差可以提高血泵效率,增大压头。The blade cut surface of the built-in blade (8) and the external blade (9) adopts the airfoil-shaped blade cut surface of the marine duct propeller. When the blood flows through the airfoil-shaped cut surface, a positive pressure appears on the leaf cut surface leaf. Negative pressure occurs on the back of the cut leaf, and the pressure difference between the leaf surface and the leaf back can increase the efficiency of the blood pump and increase the pressure head.
此外,可以理解,在本发明的其它某些实施方式中,内置桨叶(8)和外置桨叶(9)的叶切面也可以不采用船用导管螺旋桨的机翼形叶片切面形 式,而采用其它的形式,例如,可以是一般泵的平板叶切面形式。In addition, it will be appreciated that in other certain embodiments of the invention, the blade sections of the inner blade (8) and the outer blade (9) may also be shaped without the airfoil blade of the marine conduit propeller. Alternatively, other forms may be used, for example, in the form of a flat leaf cut of a general pump.
在本实施方式中,泵体转子采用机翼型叶剖面及大、小串列转子,特别是大、小串列转子叶片。数据表明,在转速7500转/分~8000转/分,压力90mmHg~100mmHg情况下,大、小转子叶片泵出流量要比单个小转子叶片泵出的流量大2升/分钟左右。图2是该浆轴一体化串列桨叶的结构示意图。In the present embodiment, the pump body rotor employs a wing-shaped blade section and large and small tandem rotors, particularly large and small tandem rotor blades. The data shows that at a speed of 7500 rpm to 8000 rpm and a pressure of 90 mmHg to 100 mmHg, the flow rate of the large and small rotor blades is 2 liters/minute larger than that of the single small rotor blade. 2 is a schematic view showing the structure of the slurry shaft integrated tandem blade.
图3是该浆轴一体化串列桨叶的叶切面及其受力示意图。Fig. 3 is a schematic view showing the blade cut surface of the slurry shaft integrated tandem blade and its force.
浆轴一体化串列桨叶(6)与电机支架(4)的内壁和磁钢(5)的内孔之间构成血液流动的主流道(11)和(12);磁钢(5)的外壁与电机支架(4)的内壁之间构成血液流动的支流道(13)和(14)。The slurry shaft integrated tandem blade (6) forms a mainstream flow (11) and (12) of blood flow between the inner wall of the motor bracket (4) and the inner hole of the magnetic steel (5); the magnetic steel (5) The outer wall and the inner wall of the motor bracket (4) constitute branch passages (13) and (14) for blood flow.
主流道内,没有其他任何阻碍物,因此流道通畅,允许大流量的血液顺畅通过。There are no other obstructions in the main channel, so the flow path is smooth, allowing large amounts of blood to pass smoothly.
在支流道(13)和(14)内没有任何阻碍物阻碍血液流过,且由于支流道间隙很小,定子线圈(3)和磁钢(5)的气隙也很小,从而显著减小血泵的体积和重量。There are no obstructions in the branch channels (13) and (14) that impede the flow of blood, and because the gap between the branch channels is small, the air gap between the stator coil (3) and the magnetic steel (5) is also small, thereby significantly reducing The volume and weight of the blood pump.
采用内置桨叶(8)在前,外置桨叶(9)在后的结构,可以保证血液从血流进口(15)进入流道时,先受到内置串列桨叶(8)转动叶片的作用,保证绝大部分血液从主流道通过,而微量血液则借助于设置在后面的外置桨叶(9)的叶梢部分作用通过,这样可以保证血液在主、支流道内顺利分叉,流畅通过,不产生拥塞血栓现象。With the built-in paddle (8) in front and the outer paddle (9) in the rear structure, it can ensure that blood enters the flow channel from the blood flow inlet (15), and then the built-in tandem blade (8) rotates the blade first. The role is to ensure that most of the blood passes through the main channel, and the trace blood is passed through the tip of the outer blade (9) disposed behind, so that the blood can be smoothly split in the main and branch channels, and the flow is smooth. Pass, no congestion thrombosis.
考虑到此植入式自悬浮轴流血泵用于植入式心室辅助装置,对结构的密封性有很高的要求,若采用常规的无刷直流电动机位置传感器,则因传感器定子霍尔元件出线过多(至少5根),带来引线密封以及引线材料与人体排异的作用,本发明采用电路实现可鉴别转子位置和自起动的功能,起到了位置传感器的功能,可以取消常规无刷直流电动机必备的位置传感器,这样既 减小密封的难度,提高了可靠性,又简化了结构,缩小了体积。Considering that the implantable self-suspended shaft blood pump is used for the implantable ventricular assist device, there is a high requirement for the structural sealing. If a conventional brushless DC motor position sensor is used, the sensor stator Hall element is used. Excessive out-of-line (at least 5), leading to lead seal and lead material and human body rejection, the present invention uses a circuit to realize the function of identifying the rotor position and self-starting, and functions as a position sensor, which can cancel the conventional brushless The necessary position sensor for the DC motor, so that Reducing the difficulty of sealing, improving reliability, simplifying the structure and reducing the volume.
转子包括空心的圆柱形磁钢和固定在其中的内置桨叶,转子直接置于定子中间,定子和转子之间不以轴承直接或间接地连接,转子在转动时自行脱离与定子内壁的接触,呈自悬浮状态。因为没有使用轴承或磁悬浮控制,所以血泵的体积更小,重量更轻,不会因为轴承的机械故障而停止转动,可靠性更高,而且避免了在轴承位置形成血栓。The rotor comprises a hollow cylindrical magnetic steel and a built-in paddle fixed therein, the rotor is directly placed in the middle of the stator, and the stator and the rotor are not directly or indirectly connected by bearings, and the rotor is free from contact with the inner wall of the stator when rotating, Self-suspended. Because no bearing or magnetic levitation control is used, the blood pump is smaller in size, lighter in weight, does not stop rotating due to mechanical failure of the bearing, is more reliable, and avoids the formation of a thrombus at the bearing position.
图4是该定子、转子结构的径向剖面示意图。4 is a schematic radial cross-sectional view of the stator and rotor structure.
当定子线圈(3)通电后,在定子线圈(3)的内壁和磁钢(5)的外壁之间的气隙产生旋转磁场带动磁钢(5)旋转,由于磁钢旋转离心力的作用,磁钢瞬间脱离与定子线圈接触的初始状态,并且囿于电机支架(4)的内壁,且介质是不可压缩流体,磁钢很快达到与定子线圈同轴的悬浮旋转状态,并驱动与磁钢连成一体的桨轴一体化串列桨叶(6)一起转动,血液便从泵体的血流进口(15)吸入,从出口流出。When the stator coil (3) is energized, an air gap between the inner wall of the stator coil (3) and the outer wall of the magnetic steel (5) generates a rotating magnetic field to drive the magnetic steel (5) to rotate, due to the centrifugal force of the magnetic steel, magnetic The steel instantaneously disengages from the initial state of contact with the stator coil, and lies on the inner wall of the motor bracket (4), and the medium is an incompressible fluid, and the magnetic steel quickly reaches a state of suspension rotation coaxial with the stator coil, and drives the magnetic steel. The integrated paddle shaft integrated serial blade (6) rotates together, and blood is sucked from the blood flow inlet (15) of the pump body and flows out from the outlet.
图5是该植入式自悬浮轴流血泵的初始状态结构示意图(剖面图);图6是该植入式自悬浮轴流血泵的悬浮状态结构示意图(剖面图),其中,编号20表示的是磁钢外径,21表示的是电机支架内径。5 is a schematic structural view (cross-sectional view) of the initial state of the implantable self-suspended axial blood pump; FIG. 6 is a schematic structural view (cross-sectional view) of the floating state of the implantable self-suspended axial blood pump, wherein the number is 20 Indicates the outer diameter of the magnetic steel, and 21 indicates the inner diameter of the motor bracket.
该植入式自悬浮轴流血泵结构简单,体积小,重量轻,血液由主流道和支流道分叉,流动顺畅,无拥塞血栓现象,无轴承磨擦,运转平衡,使用舒适,血泵效率高,溶血和防血栓性能良好,完全适合于用作植入式心室辅助装置。发明人根据以上原理,已研发出多种尺寸的样机,均可以正常运转。例如,定子铁芯的外径、内径及长度可以分别是(mm):10.5×8.7×11.5;14.5×12.4×15.5;20.5×17.7×30;29×22.8×33;35.5×29.6×60;对应的电机线圈的外径、内径及长度范围可以分别是(mm):8.7×7.5×12.5;12.4×10.3×17.5;17.7×12.6×32.5;22.8×20.5×38;29.6×26.6×65.5。 The implantable self-suspended axial blood pump has the advantages of simple structure, small volume, light weight, blood bifurcation by the main channel and the branch channel, smooth flow, no congestion and thrombus, no bearing friction, balanced operation, comfortable use, and blood pump efficiency. High, hemolysis and anti-thrombosis properties, fully suitable for use as an implantable ventricular assist device. Based on the above principles, the inventors have developed prototypes of various sizes, all of which can operate normally. For example, the outer diameter, inner diameter and length of the stator core may be (mm): 10.5×8.7×11.5; 14.5×12.4×15.5; 20.5×17.7×30; 29×22.8×33; 35.5×29.6×60; The outer diameter, inner diameter and length of the motor coil may be (mm): 8.7 x 7.5 x 12.5; 12.4 x 10.3 x 17.5; 17.7 x 12.6 x 32.5; 22.8 x 20.5 x 38; 29.6 x 26.6 x 65.5.
以其中一台为例,其已经成功地旋转了四个月,目前仍在正常稳定运转。该样机可全方位启动和停止,在一定外力(撞击或晃动等)的冲击下可正常运转。同时,发明人对该植入式自悬浮轴流血泵进行疲劳试验,并由电脑进行实时记录,其中,在断断续续启、停的情况下,样机也能正常运转。Taking one of them as an example, it has been successfully rotated for four months and is still operating normally. The prototype can be started and stopped in all directions, and can operate normally under the impact of a certain external force (impact or sway, etc.). At the same time, the inventor performed a fatigue test on the implantable self-suspended shaft blood pump and recorded it in real time by a computer, wherein the prototype can also operate normally in the case of intermittent start and stop.
下表是该样机从2011年11月17日运转至今的实验测试数据表。The following table shows the experimental test data sheets of the prototype from November 17, 2011.
日期date 转速RPMSpeed RPM 压力MMHGPressure MMHG 电流ACurrent A 流量L/MINFlow rate L/MIN
2011.12.072011.12.07 76107610 99.1099.10 0.550.55 4.854.85
2011.12.122011.12.12 75997599 98.7098.70 0.550.55 4.904.90
2011.12.172011.12.17 76237623 99.8099.80 0.550.55 4.814.81
2011.12.222011.12.22 76307630 99.8199.81 0.550.55 4.504.50
2012.01.092012.01.09 76847684 99.1599.15 0.550.55 4.804.80
2012.01.142012.01.14 76007600 98.7098.70 0.550.55 4.804.80
2012.01.192012.01.19 75577557 94.2994.29 0.510.51 4.404.40
2012.01.242012.01.24 77047704 97.6297.62 0.550.55 4.854.85
2012.01.292012.01.29 75507550 94.0294.02 0.510.51 4.404.40
2012.02.052012.02.05 74887488 94.0194.01 0.510.51 4.804.80
2012.02.102012.02.10 74087408 93.8093.80 0.510.51 4.804.80
2012.02.152012.02.15 75017501 95.0095.00 0.520.52 4.814.81
该自悬浮轴流血泵泵体进行了优化,结构紧凑,主通道节点少,轴向密封性能好。泵体可以显著缩短。本发明所述的电机铁芯的外径、内径及长度范围(mm)可以根据本发明的设计方案适当调整。The self-suspended shaft blood pump body is optimized, compact in structure, has few main channel nodes, and has good axial sealing performance. The pump body can be significantly shortened. The outer diameter, inner diameter and length range (mm) of the motor core according to the present invention can be appropriately adjusted according to the design of the present invention.
并且,发明人对该植入式自悬浮轴流血泵样机在不同的压力下进行测试,得到以下数据:Moreover, the inventors tested the implantable self-suspended axial blood pump prototype under different pressures and obtained the following data:
Figure PCTCN2014086750-appb-000001
Figure PCTCN2014086750-appb-000001
Figure PCTCN2014086750-appb-000002
Figure PCTCN2014086750-appb-000002
从以上测试数据中可以看出:血泵的功耗在正常工况下从14~20w中变化,对应泵温度保持在38摄氏度以下。It can be seen from the above test data that the power consumption of the blood pump varies from 14 to 20w under normal working conditions, and the corresponding pump temperature is kept below 38 degrees Celsius.
实验观察到,血泵的转速范围在4000rpm~8000rpm之间,对应流量在同等压力下(100mmHg)变化为2~6L/min。转速为8000rpm时,对应流量为6L/min左右。转速可以进一步提高,对应流量等相关指标也上升。It has been observed experimentally that the rotational speed of the blood pump ranges from 4000 rpm to 8000 rpm, and the corresponding flow rate varies from 2 to 6 L/min under the same pressure (100 mmHg). When the rotation speed is 8000 rpm, the corresponding flow rate is about 6 L/min. The speed can be further increased, and the relevant indicators such as the corresponding flow rate also rise.
在疲劳试验中,本发明的轴流自悬浮泵可连续转动一年零四个月以上。In the fatigue test, the axial flow self-suspending pump of the present invention can continuously rotate for one year and four months or more.
虽然通过参照本发明的某些优选实施方式,已经对本发明进行了图示和描述,但本领域的普通技术人员应该明白,可以在形式上和细节上对其作各种改变,而不偏离本发明的精神和范围。 Although the invention has been illustrated and described with reference to the preferred embodiments of the present invention, it will be understood The spirit and scope of the invention.

Claims (15)

  1. 一种植入式自悬浮轴流血泵,其特征在于,包括:定子和转子,其中定子包括:定子铁芯(2)、定子线圈(3)和电机支架(4);转子包括:含有磁性材料的磁钢(5)和内置桨叶(8);An implantable self-suspended axial blood flow pump, comprising: a stator and a rotor, wherein the stator comprises: a stator core (2), a stator coil (3) and a motor bracket (4); the rotor comprises: a magnetic material Magnetic steel (5) and built-in paddles (8);
    在该血泵的横截面中,沿径向由内到外依次为:内置桨叶(8)、磁钢(5)、电机支架(4)、定子线圈(3)和定子铁芯(2);In the cross section of the blood pump, the radial direction from the inside to the outside is: built-in paddle (8), magnetic steel (5), motor bracket (4), stator coil (3) and stator core (2) ;
    定子和转子之间不以轴承连接。There is no bearing connection between the stator and the rotor.
  2. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,电机支架(4)和磁钢(5)之间的间隙范围在0.003D~0.019D之间,D为磁钢(5)横截面的内直径。The implantable self-suspended axial blood pump according to claim 1, wherein the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.003D to 0.019D, and D is a magnetic steel. (5) The inner diameter of the cross section.
  3. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,电机支架(4)和磁钢(5)之间的间隙范围在0.0042D~0.0048D之间,D为磁钢(5)横截面的内直径。The implantable self-suspended axial blood pump according to claim 1, wherein the gap between the motor bracket (4) and the magnetic steel (5) ranges from 0.0042D to 0.0048D, and D is a magnetic steel. (5) The inner diameter of the cross section.
  4. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,磁钢(5)的厚度范围在1.5mm~3.5mm之间。The implantable self-suspended axial blood pump according to claim 1, characterized in that the thickness of the magnetic steel (5) ranges from 1.5 mm to 3.5 mm.
  5. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,磁钢(5)的厚度范围在2.0mm~3.0mm之间。The implantable self-suspended axial blood pump according to claim 1, wherein the thickness of the magnetic steel (5) ranges from 2.0 mm to 3.0 mm.
  6. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,磁钢(5)的厚度范围在2.3mm~2.8mm之间。The implantable self-suspended axial blood pump according to claim 1, wherein the thickness of the magnetic steel (5) ranges from 2.3 mm to 2.8 mm.
  7. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,还包括:桨轴(10),和/或外置桨叶(9);The implantable self-suspended axial blood pump according to claim 1, further comprising: a paddle shaft (10), and/or an external paddle (9);
    外置桨叶(9)大于内置桨叶(8),外置桨叶(9)靠近植入式自悬浮轴流血泵的血流出口一端,置于磁钢(5)的中心孔洞的外部。 The outer paddle (9) is larger than the inner paddle (8), and the outer paddle (9) is adjacent to the blood outlet end of the implantable self-suspended shaft blood pump, and is placed outside the central hole of the magnetic steel (5). .
  8. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,所述内置桨叶(8)和外置桨叶(9)的叶切面采用船用导管螺旋桨的机翼形叶片切面形式。The implantable self-suspended axial blood pump according to claim 1, characterized in that the leaf-cut surface of the inner blade (8) and the outer blade (9) adopts a wing-shaped blade section of a marine conduit propeller. form.
  9. 根据权利要求1所述的植入式自悬浮轴流血泵,其特征在于,还包括:出口右旋定子(7),该出口右旋定子(7)置于植入式自悬浮轴流血泵的血流出口端,与电机支架(4)固定在一起。The implantable self-suspended axial blood pump according to claim 1, further comprising: an outlet right-handed stator (7), the outlet right-handed stator (7) being placed on the implantable self-suspended shaft for bleeding The blood outlet end of the pump is fixed to the motor bracket (4).
  10. 根据权利要求1至8中任一项所述的植入式自悬浮轴流血泵,其特征在于,外置桨叶(9)与电机支架(4)的内壁之间构成血液流动的主流道(11),内置桨叶(8)与磁钢(5)内壁之间构成血液流动的主流道(12);磁钢(5)的外壁与电机支架(4)的内壁之间构成血液流动的支流道(13)和(14)。The implantable self-suspended axial blood pump according to any one of claims 1 to 8, characterized in that the mainstream of the blood flow is formed between the outer paddle (9) and the inner wall of the motor bracket (4). (11) a main flow path (12) between the built-in paddle (8) and the inner wall of the magnetic steel (5) to form a blood flow; the outer wall of the magnetic steel (5) and the inner wall of the motor support (4) constitute a blood flow Branch runners (13) and (14).
  11. 根据权利要求9所述的植入式自悬浮轴流血泵,其特征在于,在该血泵中不包括确定定子和转子之间相对位置的位置传感器。The implantable self-suspended axial blood pump according to claim 9, wherein a position sensor that determines a relative position between the stator and the rotor is not included in the blood pump.
  12. 根据权利要求10所述的植入式自悬浮轴流血泵,其特征在于,所述定子线圈(3)采用空心杯绕组。The implantable self-suspended axial blood pump according to claim 10, characterized in that the stator coil (3) is a hollow cup winding.
  13. 根据权利要求11所述的植入式自悬浮轴流血泵,其特征在于,所述磁钢(5)是由一个铷铁硼永磁材料制成的、径向充磁和一对极的圆柱磁环。The implantable self-suspended axial blood pump according to claim 11, wherein the magnetic steel (5) is made of a neodymium-iron-boron permanent magnet material, radially magnetized and a pair of poles. Cylindrical magnetic ring.
  14. 根据权利要求12所述的植入式自悬浮轴流血泵,其特征在于,所述定子采用二相导通,三相六状态的导电模式。The implantable self-suspended axial blood flow pump according to claim 12, wherein the stator adopts a two-phase conduction, three-phase six-state conduction mode.
  15. 根据权利要求13所述的植入式自悬浮轴流血泵,其特征在于,所述定子的外部固定有电机外壳(1)。 The implantable self-suspended axial blood pump according to claim 13, wherein a motor housing (1) is fixed to an exterior of the stator.
PCT/CN2014/086750 2013-09-17 2014-09-17 Implanted self-suspended axial flow blood pump WO2015039605A1 (en)

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