WO2022021798A1 - 介入式心室辅助装置 - Google Patents

介入式心室辅助装置 Download PDF

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Publication number
WO2022021798A1
WO2022021798A1 PCT/CN2020/141796 CN2020141796W WO2022021798A1 WO 2022021798 A1 WO2022021798 A1 WO 2022021798A1 CN 2020141796 W CN2020141796 W CN 2020141796W WO 2022021798 A1 WO2022021798 A1 WO 2022021798A1
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WO
WIPO (PCT)
Prior art keywords
impeller
interventional
hole
tube
assist device
Prior art date
Application number
PCT/CN2020/141796
Other languages
English (en)
French (fr)
Inventor
余顺周
Original Assignee
深圳核心医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳核心医疗科技有限公司 filed Critical 深圳核心医疗科技有限公司
Priority to JP2021548151A priority Critical patent/JP7258167B2/ja
Priority to CA3160690A priority patent/CA3160690A1/en
Priority to EP20919392.9A priority patent/EP4190391A1/en
Priority to AU2020460652A priority patent/AU2020460652B2/en
Priority to US17/429,951 priority patent/US11801378B2/en
Publication of WO2022021798A1 publication Critical patent/WO2022021798A1/zh

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Classifications

    • 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
    • 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
    • A61M60/10—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
    • A61M60/13—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 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • 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
    • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow 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
    • A61M60/822—Magnetic bearings specially adapted for being actively controlled
    • 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
    • A61M60/824—Hydrodynamic or fluid film bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A61M60/825—Contact bearings, e.g. ball-and-cup or pivot bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/827—Sealings between moving parts
    • A61M60/829—Sealings between moving parts having a purge fluid supply
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D13/00—Pumping installations or systems
    • F04D13/02—Units comprising pumps and their driving means
    • F04D13/06—Units comprising pumps and their driving means the pump being electrically driven
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D25/00—Pumping installations or systems
    • F04D25/02—Units comprising pumps and their driving means
    • F04D25/08—Units comprising pumps and their driving means the working fluid being air, e.g. for ventilation
    • F04D25/082—Units comprising pumps and their driving means the working fluid being air, e.g. for ventilation the unit having provision for cooling the motor
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/04—Shafts or bearings, or assemblies thereof
    • F04D29/041—Axial thrust balancing
    • F04D29/0413—Axial thrust balancing hydrostatic; hydrodynamic thrust bearings
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/18—Rotors
    • F04D29/181—Axial flow rotors
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C32/00—Bearings not otherwise provided for
    • F16C32/04—Bearings not otherwise provided for using magnetic or electric supporting means
    • F16C32/0406—Magnetic bearings
    • F16C32/044—Active magnetic bearings
    • F16C32/0474—Active magnetic bearings for rotary movement
    • F16C32/0493—Active magnetic bearings for rotary movement integrated in an electrodynamic machine, e.g. self-bearing motor
    • F16C32/0495—Active magnetic bearings for rotary movement integrated in an electrodynamic machine, e.g. self-bearing motor generating torque and axial force
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C32/00—Bearings not otherwise provided for
    • F16C32/06—Bearings not otherwise provided for with moving member supported by a fluid cushion formed, at least to a large extent, otherwise than by movement of the shaft, e.g. hydrostatic air-cushion bearings
    • F16C32/0629—Bearings not otherwise provided for with moving member supported by a fluid cushion formed, at least to a large extent, otherwise than by movement of the shaft, e.g. hydrostatic air-cushion bearings supported by a liquid cushion, e.g. oil cushion
    • F16C32/0633—Bearings not otherwise provided for with moving member supported by a fluid cushion formed, at least to a large extent, otherwise than by movement of the shaft, e.g. hydrostatic air-cushion bearings supported by a liquid cushion, e.g. oil cushion the liquid being retained in a gap
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C37/00—Cooling of bearings
    • F16C37/005—Cooling of bearings of magnetic bearings
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C39/00—Relieving load on bearings
    • F16C39/04—Relieving load on bearings using hydraulic or pneumatic means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C2316/00—Apparatus in health or amusement
    • F16C2316/10—Apparatus in health or amusement in medical appliances, e.g. in diagnosis, dentistry, instruments, prostheses, medical imaging appliances
    • F16C2316/18—Pumps for pumping blood

Definitions

  • the present application relates to the technical field of medical devices, in particular to an interventional ventricular assist device.
  • the statements herein merely provide background information related to the present application and do not necessarily constitute prior art.
  • the traditional interventional ventricular assist device uses mechanical bearings to realize the rotation of the impeller, which has mechanical friction, which will bring potential blood compatibility risks, and the bearing connections of the mechanical bearings are prone to thrombus formation.
  • One of the objectives of the embodiments of the present application is to provide an interventional ventricular assist device, which aims to solve the problem of the risk of blood compatibility caused by mechanical friction of the interventional ventricular assist device in the conventional technology.
  • an interventional ventricular assist device including an interventional tube, a motor assembly, a liquid injection cylinder and an impeller assembly; wherein:
  • the intervention tube has a liquid inlet and a liquid outlet
  • the impeller assembly includes an impeller housed in the interventional tube, the impeller being rotatable so that liquid can enter the interventional tube from the liquid inlet and flow out from the liquid outlet;
  • the motor assembly can generate a rotating magnetic field to drive the impeller to rotate, and the motor assembly can generate an attractive force on the impeller;
  • the injection cylinder can inject perfusate into the interventional tube, and the perfusion liquid injected through the injection cylinder can provide a thrust to the impeller assembly, so that the impeller can operate under the thrust and all conditions. Under the combined action of the attractive force, it is suspended and rotated in the interventional tube.
  • the beneficial effect of the interventional ventricular assist device provided by the embodiment of the present application is that the interventional ventricular assist device provided by the embodiment of the present application generates a rotating magnetic field through the motor assembly to drive the impeller to rotate, and the motor assembly can attract the impeller and inject liquid.
  • the perfusion liquid injected into the cylinder gives a thrust to the impeller assembly, so that the impeller can suspend and rotate under the combined action of thrust and attractive force.
  • it avoids the mechanical friction between the impeller and other parts, and not only avoids the abrasive produced by mechanical friction.
  • the interventional ventricular assist device of the present application has less vibration during operation, which makes the patient more comfortable.
  • FIG. 1 is a schematic perspective view of an interventional ventricular assist device according to an embodiment of the present application.
  • Fig. 2 is another perspective perspective view of the interventional ventricular assist device in Fig. 1;
  • FIG. 3 is an exploded schematic view of the interventional ventricular assist device in FIG. 2;
  • FIG. 4 is a schematic side view of the interventional ventricular assist device in FIG. 1;
  • Fig. 5 is the AA cross-sectional view of the interventional ventricular assist device in Fig. 4;
  • FIG. 6 is an enlarged view of the middle region of the interventional ventricular assist device in FIG. 4;
  • Fig. 7 is the perspective schematic diagram of the casing in Fig. 1;
  • FIG. 8 is a schematic top view of the casing in FIG. 7;
  • Fig. 9 is the BB sectional view of the casing in Fig. 8.
  • Fig. 10 is another perspective schematic diagram of the casing in Fig. 8.
  • Figure 11 is a CC cross-sectional view of the casing in Figure 10;
  • Figure 12 is a perspective view of the impeller in Figure 6;
  • Fig. 13 is another perspective perspective view of the impeller in Fig. 12;
  • Figure 14 is a schematic top view of the impeller in Figure 13;
  • Figure 15 is a DD cross-sectional view of the impeller in Figure 14;
  • FIG. 16 is a schematic structural diagram of a casing provided by another schematic diagram of the application.
  • interventional ventricular assist device 10, interventional tube; 11, liquid inlet; 12, liquid outlet; 13, first channel; 14, straight pipe section; 15, elbow section; 20, impeller assembly; 21, impeller 211, hub; 2111, first installation slot; 2111a, straight hole; 2111b, inclined hole; 2112, second installation slot; 2113, guide hole; 2114, blade; 2115, cylindrical section; 2116, conical Section; 212, magnetic parts; 213, sealing cover; 22, drive shaft; 30, motor assembly; 31, stator; 32, casing; 321, annular groove; 322, limit groove; 3221, notch; 3222, bottom wall; 323, cylinder; 324, hole assembly; 3241, first hole; 3242, second hole; 325, step; 33, cover plate; 331, through hole; 40, liquid injection cylinder; 41, second channel; 42. Outlet holes.
  • the interventional ventricular assist device 100 can be used for the right ventricle or the left ventricle. When used in the left ventricle, it can be inserted into the left ventricle via the aorta.
  • the interventional ventricular assist device 100 includes an interventional tube 10 , an impeller assembly 20 , a motor assembly 30 and a liquid injection cylinder 40 .
  • the motor assembly 30 is connected between the interventional tube 10 and the infusion cartridge 40 .
  • the motor assembly 30 is capable of generating a rotating magnetic field
  • the impeller assembly 20 is capable of rotating under the rotating magnetic field generated by the motor assembly 30 to provide power to flow a liquid (eg, blood).
  • the interventional tube 10 has a liquid inlet 11 and a liquid outlet 12 .
  • the liquid inlet 11 is used for blood to enter the interventional tube 10
  • the liquid outlet 12 is used for blood to flow out of the interventional tube 10 .
  • the liquid inlet 11 and the liquid outlet 12 are located at two ends of the interventional tube 10, respectively.
  • the interventional tube 10 is a structure whose outer diameter is adapted to the inner diameter of the aorta.
  • the interventional tube 10 has a generally conical tip to facilitate guided insertion into a blood vessel.
  • the liquid inlets 11 are provided at the tip, and a plurality of liquid inlets 11 are arranged at intervals around the central axis of the tip.
  • the liquid outlet 12 is located on the tube wall of the end of the intervention tube 10 away from the liquid inlet 11 , that is, the liquid outlet 12 is radially arranged (in this paper, the extension direction of the rotation axis of the impeller assembly 20 is defined as Axial, the direction perpendicular to the axis of rotation of the impeller assembly 20 is radial).
  • the interventional tube 10 includes a straight tube section 14 and an elbow section 15 that is bent and extended from one end of the straight tube section 14 .
  • the liquid outlet 12 is located on the pipe wall of the end of the straight pipe section 14 away from the curved pipe section 15, and the impeller 21 is rotatably accommodated in the straight pipe section 14.
  • the conical tip is located at the end of the curved pipe section 15 remote from the straight pipe section 14 .
  • the number of the liquid outlet 12 and the liquid inlet 11 is not limited to a plurality, the number of the liquid outlet 12 and the liquid inlet 11 can also be one, and the number of the liquid outlet 12 and the liquid inlet 11 can be as required Make settings.
  • the impeller assembly 20 includes an impeller 21 housed in the interventional tube 10 , and the impeller 21 is rotatable to enable liquid (eg, blood) to enter the interventional tube 10 from the liquid inlet 11 and flow out from the liquid outlet 12 . That is, the rotation axis of the impeller assembly 20 is the rotation axis of the impeller 21 . Specifically, the impeller 21 is disposed close to one end of the liquid outlet 12 of the interventional tube 10 . When the interventional ventricular assist device 100 is used in the left ventricle, the blood in the left ventricle enters the interventional tube 10 from the liquid inlet 11 , and then flows out of the interventional tube 10 through the liquid outlet 12 into the aorta.
  • liquid eg, blood
  • the impeller 21 includes a hub 211 and a magnetic member 212 disposed in the hub 211 .
  • the magnetic member 212 is annular, and further, the magnetic member 212 is a Halbach array magnetic ring.
  • the motor assembly 30 can generate a rotating magnetic field to drive the impeller 21 to rotate.
  • the motor assembly 30 is disposed at one end of the interventional tube 10 having the liquid outlet 12 .
  • the impeller 21 rotates under the cooperation of the magnetic member 212 and the motor assembly 30 .
  • the cooperation of the magnetic member 212 and the motor assembly 30 can also realize the radial suspension of the impeller 21 .
  • the suspension of the impeller 21 is referred to as the suspension of the impeller 21 .
  • the impeller 21 is provided with a perfusion liquid.
  • the hydraulic thrust has at least a force capable of urging the impeller 21 to move in a direction away from the motor assembly 30 , so as to realize the suspension of the impeller 21 in the axial direction. That is, the injection cylinder 40 can inject perfusate into the interventional tube 10, and the perfusion liquid injected through the injection cylinder 40 can provide a thrust to the impeller assembly 20, so that the impeller 21 can be under the joint action of the motor assembly 30 and the perfusion liquid.
  • the suspension is rotated in the interventional tube 10 . That is, the impeller 21 can suspend and rotate under the combined action of the force between the motor assembly 30 and the impeller 21 and the force of the injected perfusion liquid on the impeller assembly 20 . In other words, the thrust must at least cancel the attractive force between the motor assembly 30 and the magnetic member 212 of the impeller 21 , so that the impeller 21 is suspended in the axial direction. However, the suspended rotation of the impeller 21 causes no mechanical friction between the impeller 21 and the intervening tube 10 .
  • a rotating magnetic field is generated by the motor assembly 30 to drive the impeller 21 to rotate, and a thrust is provided to the impeller 21 through the perfusion fluid, so that the impeller 21 can move between the motor assembly 30 and the impeller 21 Under the combined action of the acting force and the acting force of the injected perfusion fluid on the impeller assembly 20, the impeller assembly 20 is suspended and rotated.
  • the mechanical friction between the impeller 21 and other parts is avoided, and the abrasive particles generated by the mechanical friction are not only prevented from affecting the blood. contamination risk, but also prevent the risk of easy thrombus formation at the mechanical bearing.
  • the vibration of the interventional ventricular assist device 100 of the present application during operation is smaller, which makes the patient more comfortable.
  • the perfusate is heparin-containing glucose or heparin-containing physiological saline. It can be understood that in other implementations of the present application, the perfusion fluid can also be ordinary glucose or normal saline.
  • the perfusate can not only provide thrust to the impeller 21, but also the heparin in the perfusate can flush the impeller 21, etc., to prevent blood coagulation and reduce the formation of thrombus.
  • a limiting groove 322 and a hole assembly 324 are defined on the motor assembly 30 , the limiting groove 322 is communicated with the intervention tube 10 , the hole assembly 324 is communicated with the limiting groove 322 , and the liquid injection cylinder 40 It communicates with the hole assembly 324, so that the perfusion fluid injected through the injection cylinder 40 can flow into the interventional tube 10 through the hole assembly 324 and the limiting groove 322 in sequence. In this way, the perfusion liquid can also cool down the motor assembly 30 .
  • the limiting groove 322 has a notch 3221 and a bottom wall 3222 opposite to the notch 3221 , and the notch 3221 communicates with the intervention tube 10 .
  • the limiting groove 322 also has a side wall connected to the bottom wall 3222 , and the side wall is a cylindrical surface and extends along the axial direction of the impeller 21 .
  • the bottom wall 3222 and the side wall of the limiting groove 322 are both the groove walls of the limiting groove 322 .
  • the impeller assembly 20 further includes a transmission shaft 22 , one end of the transmission shaft 22 is fixedly connected to the impeller 21 , and the other end extends into the limiting groove 322 .
  • the transmission shaft 22 can rotate with the impeller 21 , and the end of the transmission shaft 22 away from the impeller 21 can be suspended in the limiting groove 322 .
  • the rotation axis of the transmission shaft 22 coincides with the rotation axis of the impeller 21 .
  • the hole assembly 324 is opposite to the end of the transmission shaft 22 away from the impeller 21, so that the perfusion liquid injected into the limiting groove 322 through the hole assembly 324 can provide thrust to the transmission shaft 22, so that the transmission shaft 22 and the impeller 21 can
  • the motor assembly 30 is suspended and rotated under the joint action of the perfusion solution.
  • the transmission shaft 22 passes through the slot 3221 and extends toward the direction close to the bottom wall 3222 .
  • the transmission shaft 22 is cylindrical.
  • the end surface of the end of the transmission shaft 22 away from the impeller 21 is in the shape of a convex hemispherical surface.
  • the transmission shaft 22 is located on the rotation axis of the impeller 21 , and the extension direction of the transmission shaft 22 is consistent with the rotation axis of the impeller 21 .
  • the hole assembly 324 includes a first hole 3241 , and the first hole 3241 communicates with the limiting groove 322 and the liquid injection cylinder 40 .
  • one opening of the first hole 3241 is located on the bottom wall 3222 , and the other opening communicates with the liquid injection cylinder 40 .
  • the perfusion liquid injected from the first hole 3241 will directly act on the end face of the transmission shaft 22 at one end away from the impeller 21 , giving the transmission shaft 22 a thrust in the axial direction, which is related to the attraction of the magnetic member 212 by the motor assembly 30 .
  • the forces cancel each other out so that the drive shaft 22 is balanced in its axial direction.
  • the central axis of the first hole 3241 coincides with the rotation axis of the transmission shaft 22 .
  • the center line of the first hole 3241 coincides with the center line of the limiting groove 322 .
  • the diameter of the first hole 3241 may also be the same as the diameter of the limiting slot 322 , that is, the limiting slot 322 penetrates the motor assembly 30 along the axial direction of the impeller 21 , here Not uniquely limited.
  • the hole assembly 324 further includes a plurality of second holes 3242 , and the plurality of second holes 3242 are all connected to the liquid injection cylinder 40 and the limit groove 322 , and the first hole 3241 is connected to the transmission shaft 22 .
  • a plurality of second holes 3242 are arranged around the first hole 3241 at equal intervals, and the plurality of second holes 3242 are opposite to the end face of the end face of the transmission shaft 22 that is far away from the impeller 21 .
  • the perfusion liquid injected from the plurality of second holes 3242 has at least a thrust force on the transmission shaft 22
  • the component forces in the radial direction or all of them are radial forces.
  • the axial direction of the plurality of second holes 3242 is parallel to the axial direction of the first hole 3241 , and the plurality of second holes 3242 are arranged at equal intervals around the central axis of the first hole 3241 . It should be noted that the axial directions of the plurality of second holes 3242 may not be parallel to the axial directions of the first holes 3241 .
  • the bottom wall 3222 of the limiting groove 322 is a concave hemispherical shape, and the first hole 3241 is located at the center of the bottom wall 3222 .
  • the curvature of the bottom wall 3222 of the limiting groove 322 is consistent with the curvature of the end surface of the end face of the transmission shaft 22 away from the impeller 21 . It can be understood that the curvature of the bottom wall 3222 of the limiting groove 322 may also be inconsistent with the curvature of the end surface of the end face of the transmission shaft 22 away from the impeller 21 .
  • the four second holes 3242 are arranged around the central axis of the first hole 3241 at equal intervals, and the four second holes 3242 are The holes 3242 are all located on the bottom wall of the limiting groove 322 . It can be understood that, in other embodiments of the present application, according to actual design requirements, the number of the second holes 3242 may also be three, five, or more than five, which is not limited here.
  • the form of the hole assembly 324 is not limited to the above-mentioned form.
  • the hole assembly 324 includes a plurality of first holes 3241 , and the plurality of first holes 3241 are all connected to the end of the transmission shaft 22 away from the impeller 21 .
  • the end faces of the two are opposite to each other, and the plurality of first holes 3241 are evenly and spaced apart around the rotation axis of the transmission shaft 22 .
  • the hole assembly 324 further has a plurality of second holes 3242 , the plurality of second holes 3242 are arranged around the rotation axis of the transmission shaft 22 and are located on the periphery of the plurality of first holes 3241 .
  • the motor assembly 30 includes a casing 32 and a stator 31 , and the casing 32 is sealedly connected to the intervention tube 10 and the liquid injection cylinder 40 .
  • the casing 32 is disposed at one end of the intervention tube 10 close to the liquid outlet 12 , and the liquid injection cylinder 40 is located at the side of the casing 32 away from the intervention tube 10 .
  • the insertion tube 10 has a first channel 13 , the first channel 13 communicates with the liquid inlet 11 and the liquid outlet 12 respectively, and the impeller 21 is accommodated in the first channel 13 .
  • the stator 31 is sealed and installed on the casing 32 , the limiting groove 322 , the first hole 3241 and the second hole 3242 are all opened in the casing 32 , and the liquid injection cylinder 40 is provided with a second hole which is respectively communicated with the first hole 3241 and the second hole 3242 .
  • Two channels 41 By opening the limiting slot 322 , the first hole 3241 and the second hole 3242 in the casing 32 , the perfusion liquid can also cool down the motor assembly 30 and improve the service life of the motor assembly 30 .
  • the interventional tube 10 , the casing 32 and the liquid injection cylinder 40 may also be integrally formed, which is not limited herein.
  • the stator 31 and the impeller 21 are spaced apart in the axial direction, so that the impeller 21 has a larger torque, so that the impeller 21 can rotate at a lower speed, thereby reducing the shearing of the blood by the impeller 21 stress, reduce the damage of the impeller 21 to the blood, and reduce hemolysis.
  • the impeller 21 can have a larger size, which is more convenient to manufacture, and is beneficial to reduce the manufacturing cost.
  • the casing 32 defines an annular groove 321
  • the annular groove 321 surrounds the limiting groove 322 and is spaced from the limiting groove 322 .
  • the central axis of the limiting groove 322 coincides with the central axis of the casing 32
  • the annular groove 321 and the limiting groove 322 are coaxially arranged.
  • the opening of the annular groove 321 faces the liquid injection cylinder 40
  • the opening of the limiting groove 322 faces the insertion tube 10, that is, the openings of the annular groove 321 and the limiting groove 322 face different ends of the casing 32 in the axial direction, respectively.
  • the stator 31 is also annular, and the stator 31 is accommodated in the annular groove 321 .
  • the opening cover of the annular groove 321 is provided with a cover plate 33 , the cover plate 33 is annular, and the cover plate 33 is disposed on the annular groove 321 , so as to seal the stator 31 to the casing 32 .
  • the casing 32 is cylindrical as a whole.
  • the outer wall of the casing 32 is flush with the outer wall of the insertion tube 10
  • the outer wall of the casing 32 and the liquid injection cylinder 40 are flush.
  • the outer wall is flush.
  • the two ends of the casing 32 form a plug fit with the intervention tube 10 and the liquid injection cylinder 40 respectively.
  • a step 325 is formed on the peripheral edge of one end of the casing 32 , and the end of the insertion tube 10 away from the liquid inlet 11 is sleeved on the step 325 of the casing 32 to form a sealed connection by sticking, welding, hot pressing, or the like.
  • a cylindrical body 323 extends from the center of the annular groove 321 , the cylindrical body 323 and the annular groove 321 are arranged concentrically, one end of the cylindrical body 323 extends to the outside of the annular groove 321 , and the cylindrical body 323 protrudes out One end of the annular groove 321 is accommodated in the liquid injection cylinder 40 .
  • the limiting groove 322 , the first hole 3241 and the second hole 3242 are all formed in the cylinder 323 .
  • the two holes 3242 axially extend inward from the other end of the cylinder 323 to the bottom wall of the limiting groove 322 .
  • the second channel 41 extends axially along the liquid injection cylinder 40 , the centerline of the second channel 41 coincides with the centerline of the first hole 3241 , and the diameter of the second channel 41 is larger than the diameter of the outer contour circle D of each second hole 3242 .
  • the outer contour circle D of each second hole 3242 refers to the circle where the point farthest from the center line of the first hole 3241 in each second hole 3242 is located.
  • the outer contour circle D is shown as the dotted circle in FIG.
  • the liquid injection cylinder 40 is further provided with a wire outlet hole 42 , the wire outlet hole 42 is spaced from the second channel 41 , the cover plate 33 is provided with a through hole 331 at the position of the wire outlet hole 42 , and the control wires of the stator 31 are arranged in sequence. Pass through the through hole 331 and the wire outlet hole 42 and form a communication connection with an external controller.
  • the impeller 21 includes a cylindrical section 2115 and a conical section 2116, the cylindrical section 2115 and the conical section 2116 are integrally connected along the axial direction of the impeller 21, the cylindrical section 2115 is disposed close to the casing 32, and the conical section 2116 is far away from the casing 32, the magnetic member 212 is installed on the cylindrical section 2115, and one end of the transmission shaft 22 is installed at the center of the cylindrical section 2115.
  • Four vanes 2114 are distributed on the outer circumference of the conical segment 2116 , and each vane 2114 is helical and distributed on the outer wall of the conical segment 2116 .
  • the impeller 21 is provided with a first installation groove 2111 and a second installation groove 2112 .
  • the hub 211 is formed with a first installation groove 2111 and a second installation groove 2112 .
  • the openings of the first installation groove 2111 and the second installation groove 2112 are both disposed toward the casing 32
  • the first installation groove 2111 is circular and is located at the center of the entire impeller 21
  • the second installation groove 2112 is annular and surrounds the first installation groove 2111 .
  • the second installation groove 2112 is concentric with the first installation groove 2111 , that is, the center line of the second installation groove 2112 , the center line of the first installation groove 2111 and the center line of the entire impeller 21 coincide.
  • the end of the transmission shaft 22 away from the limiting groove 322 is accommodated in the first installation groove 2111
  • the magnetic element 212 is accommodated in the second installation groove 2112 , so that the magnetic element 212 , the transmission shaft 22 and the impeller 21 after installation are concentrically arranged,
  • the magnetic element 212 drives the transmission shaft 22 and the impeller 21 to rotate, and the magnetic element 212 , the transmission shaft 22 and the impeller 21 rotate coaxially.
  • the magnetic element 212 is annular, the magnetic element 212 is installed in the second installation groove 2112 , the second installation groove 2112 is also covered with a sealing cover 213 , and the magnetic element 212 is sealed and fixed to the second installation groove by the sealing cover 213 In 2112, the magnetic element 212 is prevented from being contaminated by blood or perfusate and thus losing its efficacy.
  • one end of the transmission shaft 22 is inserted into the first installation groove 2111 , and the transmission shaft 22 can be fixed in the first installation groove 2111 by means of interference fit, welding, sticking or fasteners.
  • the impeller 21 is provided with a guide hole 2113 , the guide hole 2113 has two openings, and one opening of the guide hole 2113 faces the liquid outlet 12 , The other opening is opposite to the limiting groove 322 .
  • the guide holes 2113 are specifically opened on the hub 211 .
  • each guide hole 2113 is located between the first installation groove 2111 and the second installation groove 2112 .
  • each guide hole 2113 there are multiple guide holes 2113 on the impeller 21 , the multiple guide holes 2113 are evenly spaced around the rotation axis of the impeller 21 , and one opening of each guide hole 2113 faces the liquid outlet 12 , and the other opening Opposite to the limiting groove 322 .
  • the number of guide holes 2113 is not limited to four, and the number of guide holes 2113 can also be one, two, three or more than four, and the number of guide holes 2113 can be set according to specific needs.
  • the first installation groove 2111 includes a straight hole portion 2111a and an oblique hole portion 2111b communicating with the straight hole portion 2111a, and the diameter of the inclined hole portion 2111b gradually increases along the direction away from the straight hole portion 2111a.
  • the oblique hole portion 2111b is opposite to the limiting groove 322, the opening of the guide hole 2113 away from the liquid outlet 12 is located on the side wall of the oblique hole portion 2111b; the end of the transmission shaft 22 away from the limiting groove 322 is accommodated in the oblique hole
  • the portion 2111b and the straight hole portion 2111a are fixed to the side wall of the straight hole portion 2111a.
  • a third gap is provided between the transmission shaft 22 and the inner wall of the inclined hole portion 2111b, and the perfusion fluid flowing out from the limiting groove 322 can directly enter the guide through the third gap.
  • the flow hole 2113 that is, the inclined inner wall of the inclined hole portion 2111b, plays a role of diversion, and quickly guides the perfusate or blood into the diversion hole 2113 to form a secondary flow field.
  • connection method between the hole component 324 and the limiting groove 322 can also be other ways.
  • the groove wall of the limiting groove 322 is a cylindrical surface
  • the hole component 324 includes a first The hole 3241 and the plurality of second holes 3242, the first hole 3241 and the plurality of second holes 3242 are both connected to the liquid injection cylinder 40 and the limit groove 322, and the first hole 3241 is opposite to the end face of the end of the transmission shaft 22 away from the impeller 21 Arrangement, the plurality of second holes 3242 are spaced and evenly arranged around the center line of the first hole 3241 for a circle.
  • the plurality of second holes 3242 are located on the side wall of the limiting groove 322, and the plurality of second holes 3242 are opposite to the peripheral side of the transmission shaft 22.
  • the The perfusion liquid is introduced into the limiting grooves 322 and acts on the peripheral sides of the transmission shaft 22 respectively, so as to realize the radial balance of the transmission shaft 22 .

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Abstract

一种介入式心室辅助装置（100），包括介入管（10）、电机组件（30）、注液筒（40）和叶轮组件（20）。其中，介入管（10）具有进液口（11）及出液口（12）；叶轮组件（20）包括叶轮（21），叶轮（21）收容于介入管（10）中，叶轮（21）能够旋转以使液体能够从进液口（11）进入介入管（10），并从出液口（12）流出；电机组件（30）能够产生旋转磁场以驱动叶轮（21）旋转；注液筒（40）能够供灌注液注入介入管（10），且经注液筒（40）注入的灌注液能够给叶轮组件（20）提供一推力，以使叶轮（21）能够在电机组件（30）及灌注液的共同作用下悬浮旋转于介入管（10）中。

Description

介入式心室辅助装置
本申请要求于2020年07月31日在中国专利局提交的、申请号为202010758361.8、发明名称为“介入式心室辅助装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，具体涉及一种介入式心室辅助装置。
 背景技术
这里的陈述仅提供与本申请有关的背景信息，而不必然构成现有技术。传统的介入式心室辅助装置采用机械轴承来实现叶轮旋转，其中具有机械摩擦，会带来潜在的血液兼容性风险，且机械轴承的轴承连接处容易形成血栓。
技术问题
本申请实施例的目的之一在于：提供一种介入式心室辅助装置，旨在解决传统技术中存在的介入式心室辅助装置的具有机械摩擦导致血液兼容性风险的问题。
 技术解决方案
为解决上述技术问题，本申请实施例采用的技术方案是：
第一方面，提供了一种介入式心室辅助装置，包括介入管、电机组件、注液筒及叶轮组件；其中：
所述介入管具有进液口及出液口；
所述叶轮组件包括叶轮，所述叶轮收容于所述介入管中，所述叶轮能够旋转以使液体能够从所述进液口进入所述介入管，并从所述出液口流出；
所述电机组件能够产生旋转磁场以驱动所述叶轮旋转，所述电机组件能够对所述叶轮产生吸引力；
所述注液筒能够供灌注液注入所述介入管，且经所述注液筒注入的所述灌注液能够给所述叶轮组件提供一推力，以使所述叶轮能够在所述推力及所述吸引力的共同作用下悬浮旋转于所述介入管中。
 有益效果
本申请实施例提供的介入式心室辅助装置的有益效果在于：本申请实施例提供的介入式心室辅助装置，通过电机组件产生旋转磁场以驱动叶轮旋转，电机组件能够对叶轮产生吸引力，注液筒注入的灌注液给叶轮组件一推力，以使叶轮能够在推力及吸引力的共同作用下悬浮旋转，相对于机械轴承，避免了叶轮与其它部分的机械摩擦，不仅避免了机械摩擦产生的磨料颗粒对血液的污染风险，而且还防止了机械轴承处容易形成血栓的风险。同时，相对于采用柔性部件驱动叶轮旋转的方式，本申请的介入式心室辅助装置工作时的振动更小，使患者更加舒适。
 附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例或示范性技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。
图1为本申请实施例提供的介入式心室辅助装置的立体示意图；
图2为图1中介入式心室辅助装置的另一个角度立体示意图；
图3为图2中介入式心室辅助装置的分解示意图；
图4为图1中介入式心室辅助装置的侧面示意图；
图5为图4中介入式心室辅助装置的AA剖视图；
图6为图4中介入式心室辅助装置的中间区域放大图；
图7为图1中的机壳的立体示意图；
图8为图7中的机壳的俯视示意图；
图9为图8中的机壳的BB剖视图；
图10为图8中的机壳的另一个角度示意图；
图11为图10中的机壳的CC剖视图；
图12为图6中的叶轮的立体示意图；
图13为图12中的叶轮的另一个角度立体示意图；
图14位图13中的叶轮的俯视示意图；
图15为图14中的叶轮的DD剖视图；
图16为本申请另一示意图提供的机壳的结构示意图。
其中，图中各附图标记：
100、介入式心室辅助装置；10、介入管；11、进液口；12、出液口；13、第一通道；14、直管段；15、弯管段；20、叶轮组件；21、叶轮；211、轮毂；2111、第一安装槽；2111a、直孔部；2111b、斜孔部；2112、第二安装槽；2113、导流孔；2114、叶片；2115、圆柱段；2116、锥状段；212、磁性件；213、密封盖；22、传动轴；30、电机组件；31、定子；32、机壳；321、环形槽；322、限位槽；3221、槽口；3222、底壁；323、柱体；324、孔组件；3241、第一孔；3242、第二孔；325、台阶；33、盖板；331、通孔；40、注液筒；41、第二通道；42、出线孔。
 本发明的实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本申请，并不用于限定本申请。
需说明的是，当部件被称为“固定于”或“设置于”另一个部件，它可以直接在另一个部件上或者间接在该另一个部件上。当一个部件被称为是“连接于”另一个部件，它可以是直接或者间接连接至该另一个部件上。术语“上”、“下”、“左”、“右”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制，对于本领域的普通技术人员而言，可以根据具体情况理解上述术语的具体含义。术语“第一”、“第二”仅用于便于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明技术特征的数量。“多个”的含义是两个或两个以上，除非另有明确具体的限定。
为了说明本申请所述的技术方案，以下结合具体附图及实施例进行详细说明。
如图1-6所示，为一实施方式的介入式心室辅助装置100，特别涉及一种离心式磁悬浮心室辅助装置。该介入式心室辅助装置100能够用于右心室，也能够用于左心室。当其用于左心室时，能够经由主动脉***到左心室。该介入式心室辅助装置100包括介入管10、叶轮组件20、电机组件30及注液筒40。在图示的实施例中，电机组件30连接于介入管10与注液筒40之间。电机组件30能够产生旋转磁场，叶轮组件20能够在电机组件30产生的旋转磁场下旋转，以给液体（例如，血液）提供流动的动力。
请参阅图1及图2，介入管10具有进液口11及出液口12。进液口11用于供血液进入该介入管10中，出液口12用于供血液从介入管10中流出。在图示的实施例中，进液口11和出液口12分别位于介入管10的两端。在其中一个实施例中，介入管10为外径与主动脉内径相适配的结构。介入管10具有大致圆锥状的尖端，以便于引导***血管中。进液口11设于该尖端，且环绕尖端的中心轴线间隔设置有多个。具体地，出液口12位于介入管10的远离进液口11的一端的管壁上，即出液口12为径向设置的（在本文中，定义叶轮组件20的旋转轴的延伸方向为轴向，垂直于叶轮组件20的旋转轴的方向为径向）。出液口12为多个，多个出液口12环绕介入管10的中心轴线间隔设置一周。具体地，介入管10包括直管段14及与直管段14的一端弯折延伸的弯管段15，直管段14的远离弯管段15的一端与电机组件30固接，出液口12位于弯管段15的远离直管段14的一端，出液口12位于直管段14的远离弯管段15的一端的管壁上，叶轮21能够旋转地收容于直管段14。圆锥状的尖端位于弯管段15的远离直管段14的一端。
需要说明的是，出液口12和进液口11不限于多个，出液口12和进液口11的数量也可以均为一个，出液口12和进液口11的数量可以根据需要进行设置。
叶轮组件20包括叶轮21，叶轮21收容于介入管10中，叶轮21能够旋转以使液体（例如血液）能够从进液口11进入介入管10，并从出液口12流出。即叶轮组件20的旋转轴线即为叶轮21的旋转轴线。具体地，叶轮21靠近介入管10的出液口12的一端设置。当该介入式心室辅助装置100用于左心室时，左心室中的血液从进液口11进入介入管10中，再经由出液口12从介入管10流出进入主动脉中。
具体在图示的实施例中，请参阅图6，叶轮21包括轮毂211及设置在轮毂211中的磁性件212。磁性件212为环状，进一步地，磁性件212为海尔贝克阵列磁环。
电机组件30能够产生旋转磁场以驱动叶轮21旋转。具体地，电机组件30设置在介入管10的具有出液口12的一端。叶轮21在磁性件212与电机组件30的配合下而旋转。在某些转速下，磁性件212和电机组件30的配合还能够实现叶轮21的径向悬浮。在本文中，叶轮21与介入管10的侧壁、电机组件30等不接触的状态则称之为叶轮21的悬浮。
其中，电机组件30与叶轮21之间具有吸引力，以促使叶轮21具有朝靠近电机组件30方向运动的趋势，为了实现轴向上的平衡，在本申请中，使用灌注液给叶轮21提供一液推力，该液推力至少具有能够促使叶轮21向远离电机组件30的方向运动的力，以实现叶轮21在轴向上悬浮。即注液筒40能够供灌注液注入介入管10中，且经注液筒40注入的灌注液能够给叶轮组件20提供一推力，以使叶轮21能够在电机组件30及灌注液的共同作用下悬浮旋转于介入管10中。即叶轮21能够在电机组件30与叶轮21之间的作用力、以及注入的灌注液对叶轮组件20的作用力的共同作用下悬浮旋转。换而言之，该推力至少要能够抵消电机组件30和叶轮21的磁性件212之间的吸引力，使得叶轮21在轴向上悬浮。而叶轮21的悬浮旋转，使得叶轮21与介入管10之间不存在机械摩擦。
本申请提供的介入式心室辅助装置100，通过电机组件30产生旋转磁场以驱动叶轮21旋转，并通过灌注液给叶轮21提供一推力，以使叶轮21能够在电机组件30与叶轮21之间的作用力、以及注入的灌注液对叶轮组件20的作用力的共同作用下悬浮旋转，相对于机械轴承，避免了叶轮21与其它部分的机械摩擦，不仅避免了机械摩擦产生的磨料颗粒对血液的污染风险，而且还防止了机械轴承处容易形成血栓的风险。同时，相对于采用柔性部件驱动叶轮21旋转的方式，本申请的介入式心室辅助装置100工作时的振动更小，使患者更加舒适。
在具体地实施例中，该灌注液为含有肝素的葡萄糖或者含有肝素的生理盐水。可以理解地，在本申请的其他实施中，灌注液也可以是普通的葡萄糖或生理盐水。灌注液不仅能够给叶轮21提供推力，同时灌注液中的肝素还能够对叶轮21等进行冲刷，防止血凝，减少血栓的形成。
在具体的实施例中，请参阅图6，电机组件30上开设有限位槽322和孔组件324，限位槽322与介入管10连通，孔组件324与限位槽322连通，注液筒40与孔组件324连通，以使经注液筒40注入的灌注液能够依次经过孔组件324、限位槽322流入介入管10中。如此设置，灌注液还能够对电机组件30起到冷却降温的作用。
具体在图示的实施例中，限位槽322具有槽口3221及与槽口3221相对的底壁3222，槽口3221与介入管10连通。具体地，限位槽322还具有与底壁3222连接的侧壁，侧壁为圆柱面并沿叶轮21的轴向延伸。此时，限位槽322的底壁3222和侧壁均为限位槽322的槽壁。
叶轮组件20还包括传动轴22，传动轴22的一端与叶轮21固接，另一端延伸至限位槽322中。传动轴22能够随叶轮21旋转，且传动轴22的远离叶轮21的一端能够悬浮于限位槽322中。传动轴22的旋转轴线与叶轮21的旋转轴线重合。其中，孔组件324与传动轴22的远离叶轮21的一端相对，以使经孔组件324注入限位槽322中的灌注液能够给传动轴22提供推力，以使传动轴22和叶轮21能够在电机组件30和灌注液的共同作用下悬浮旋转。那么此时，在工作时，注入限位槽322中的灌注液给传动轴22提供推力，传动轴22将该推力传导给叶轮21。具体地，传动轴22穿设于槽口3221，并朝靠近底壁3222的方向延伸。在图示的实施例中，传动轴22呈柱状。传动轴22的远离叶轮21的一端的端面为外凸的半球面状。传动轴22位于叶轮21的旋转轴线上，且传动轴22的延伸方向与叶轮21的旋转轴线一致。
在具体地实施例中，请参阅图6、图8至图11，孔组件324包括第一孔3241，第一孔3241连通限位槽322与注液筒40。在其中一个实施例中，第一孔3241的一个开口位于底壁3222上，另一个开口与注液筒40连通，第一孔3241与传动轴22的远离叶轮21的一端的端面中心相对。这样，从第一孔3241注入的灌注液将直接作用在传动轴22远离叶轮21的一端的端面上，给予传动轴22沿轴向方向的推力，该推力与电机组件30给予磁性件212的吸引力相互抵消，从而使得传动轴22沿其轴向平衡。具体地，第一孔3241的中心轴线与传动轴22的旋转轴线重合。第一孔3241的中心线与限位槽322的中心线重合。可以理解地，在本申请的其他实施例中，第一孔3241的孔径也可以与限位槽322的孔径相同，也即是限位槽322沿叶轮21的轴向贯穿电机组件30，此处不做唯一限定。
进一步地，请参与图8至图11，孔组件324还包括多个第二孔3242，多个第二孔3242均连通注液筒40和限位槽322，第一孔3241与传动轴22的远离叶轮21的一端的端面中心相对，多个第二孔3242环绕第一孔3241等间距地设置一周，且多个第二孔3242与传动轴22的远离叶轮21的一端的端面相对。由于传动轴22的远离叶轮21的一端的端面为外凸的半球面，通过按照上述方式设置多个第二孔3242，从多个第二孔3242注入的灌注液对传动轴22的推力至少存在径向上的分力或全部为径向力，由于多个第二孔3242沿周向均匀分布，则从多个第二孔3242中注入的灌注液对传动轴22的径向推力可以相互平衡，从而进一步使得传动轴22沿径向上保持悬浮平衡，防止传动轴22与限位槽322的槽壁产生机械碰撞干涉。在其中一个实施例中，多个第二孔3242的轴向与第一孔3241的轴向平行，多个第二孔3242环绕第一孔3241的中心轴线等间隔地设置一周。需要说明的是，多个第二孔3242的轴向与第一孔3241的轴向也可以不平行。
在具体的实施例中，请参阅图6，限位槽322的底壁3222为内凹的半球面状，第一孔3241位于底壁3222的中心。在其中一个实施例中，限位槽322的底壁3222的弧度与传动轴22的远离叶轮21的一端的端面的弧度一致。可以理解，限位槽322的底壁3222的弧度与传动轴22的远离叶轮21的一端的端面的弧度也可以不一致。
请参阅图9及图11，具体的图示的实施例中，第二孔3242为四个，四个第二孔3242环绕第一孔3241的中心轴线等间隔地设置一周，且四个第二孔3242均位于限位槽322的底壁。可以理解地，在本申请的其他实施例中，根据实际设计需求，第二孔3242的数量也可以为三个、五个或五个以上，此处不做唯一限定。
需要说明的是，孔组件324的形式不限于为上述形式，在其它实施例中，孔组件324包括多个第一孔3241，多个第一孔3241均与传动轴22的远离叶轮21的一端的端面相对，且多个第一孔3241环绕传动轴22的旋转轴线均匀且间隔设置。此时，若孔组件324还具有多个第二孔3242，则多个第二孔3242环绕传动轴22的旋转轴线设置，并位于多个第一孔3241的***。
在具体地实施例中，请参阅图1至图3，电机组件30包括机壳32及定子31，机壳32与介入管10、注液筒40均密封连接。机壳32设置在介入管10的靠近出液口12的一端，注液筒40位于机壳32的远离介入管10的一侧。请参阅图3及图6，介入管10具有第一通道13，第一通道13分别与进液口11及出液口12连通，叶轮21收容于第一通道13中。定子31密封安装于机壳32，限位槽322、第一孔3241及第二孔3242均开设于机壳32，注液筒40开设有分别与第一孔3241及第二孔3242连通的第二通道41。通过将限位槽322、第一孔3241及第二孔3242均开设于机壳32，使得灌注液还能够对电机组件30起到冷却降温的作用，提高电机组件30的使用寿命。可以理解地，在本申请的其他实施例中，在条件允许的情况下，介入管10、机壳32及注液筒40也可以一体成型，此处不做唯一限定。
请参阅图6，定子31与叶轮21在轴向上间隔设置，使得叶轮21具有更大的扭矩，如此可使叶轮21在较低的转速下旋转，从而能够减小叶轮21对血液的剪切应力，降低叶轮21对血液的破坏，降低溶血。且相对于传统定子31环绕叶轮21设置的方式，叶轮21能够具有更大的尺寸，制造更加方便，有利于减少制作成本。
在具体地实施例中，请参阅图3、图9及图11，机壳32开设有环形槽321，环形槽321环绕设于限位槽322设置，环形槽321与限位槽322间隔。具体地，限位槽322的中心轴线与机壳32的中心轴向重合，环形槽321与限位槽322同轴设置。环形槽321的开口朝向注液筒40，限位槽322的开口朝向介入管10，也即是环形槽321与限位槽322的开口分别朝向机壳32沿轴向上的不同端，环形槽321与限位槽322相互不连通。定子31同样呈环形，定子31收容于环形槽321中。环形槽321的开口盖设有盖板33，盖板33呈环形，且盖板33设于环形槽321上，从而将定子31密封安装于机壳32。
请参阅图6及图7，机壳32整体呈柱形。在机壳32与介入管10的连接处，机壳32的外壁和介入管10的外壁平齐，在机壳32与注液筒40的连接处，机壳32的外壁和注液筒40的外壁平齐。机壳32的两端分别与介入管10、注液筒40形成插接配合。具体地，机壳32的一端周缘形成有台阶325，介入管10远离进液口11的一端套接在机壳32的台阶325上并通过粘贴、焊接、热压等方式形成密封连接。
在具体地实施例中，请参阅图6，环形槽321的中心延伸有柱体323，柱体323与环形槽321同心设置，柱体323的一端向环形槽321外部延伸，柱体323伸出环形槽321的一端收容于注液筒40。限位槽322、第一孔3241及第二孔3242均形成于柱体323，具体地，限位槽322自柱体323朝向介入管10的一端向内轴向延伸，第一孔3241及第二孔3242自柱体323另一端向内轴向延伸至限位槽322的底壁。第二通道41沿注液筒40轴向延伸，第二通道41的中心线与第一孔3241的中心线重合，第二通道41的孔径大于各第二孔3242的外轮廓圆D的直径。此处需要说明的是，各第二孔3242的外轮廓圆D是指各第二孔3242中距离第一孔3241的中心线最远的点所在的圆，具体的，各第二孔3242的外轮廓圆D如图8中的虚线圆所示；则当第二通道41的孔径大于各第二孔3242的外轮廓圆D的直径时，从第二通道41注入的灌注液均能够注入第一孔3241及各第二孔3242中，从而实现叶轮21的轴向及径向平衡。
请参阅图6，注液筒40还开设有出线孔42，出线孔42与第二通道41间隔设置，盖板33上设于出线孔42的位置设有通孔331，定子31的控制线依次穿过通孔331及出线孔42并与外部控制器形成通信连接。
请参阅图12，叶轮21包括圆柱段2115及锥状段2116，圆柱段2115与锥状段2116沿叶轮21的轴向一体连接，圆柱段2115靠近机壳32设置，锥状段2116远离机壳32设置，磁性件212安装于圆柱段2115，传动轴22的一端安装于圆柱段2115的中心位置。锥状段2116的外周分布有四个叶片2114，各叶片2114呈螺旋状并分布于锥状段2116外壁上。
在具体地实施例中，请参阅图13至图15，叶轮21上开设有第一安装槽2111及第二安装槽2112，具体是轮毂211上形成有第一安装槽2111及第二安装槽2112。第一安装槽2111及第二安装槽2112的开口均朝向机壳32设置，第一安装槽2111呈圆形并位于整个叶轮21的中心位置，第二安装槽2112呈环形并围设于第一安装槽2111外，第二安装槽2112与第一安装槽2111同心设置，也即是第二安装槽2112的中心线、第一安装槽2111的中心线及整个叶轮21的中心线重合。传动轴22的远离限位槽322的一端收容于第一安装槽2111，磁性件212收容于第二安装槽2112，这样，使得安装后的磁性件212、传动轴22及叶轮21均同心设置，当定子31对磁性件212施加旋转磁场后，磁性件212带动传动轴22及叶轮21旋转，且磁性件212、传动轴22及叶轮21同轴旋转。
请参阅图6，磁性件212呈环形，磁性件212安装于第二安装槽2112，第二安装槽2112还盖设有密封盖213，通过密封盖213将磁性件212密封固定于第二安装槽2112中，避免磁性件212被血液或灌注液污染而损失功效。
请参阅图6，传动轴22的一端***第一安装槽2111中，传动轴22能够通过过盈配合、焊接、粘贴或紧固件等方式固定于第一安装槽2111中。
在具体地实施例中，请参阅图6、图12至图15，叶轮21上开设有导流孔2113，导流孔2113具有两个开口，导流孔2113的一个开口朝向出液口12，另一个开口与限位槽322相对。在图示的实施例中，导流孔2113具体是开设于轮毂211上。通过导流孔2113的设置，使得从第二通道41注入限位槽322的灌注液可通过导流孔2113进入介入管10并从出液口12流出；同时也使得从介入管10与叶轮21之间的第一间隙流至叶轮21与机壳32之间的第二间隙的血液可以通过导流孔2113回流至出液口12，形成二次流场，以对血液进行冲刷，减少血液的滞留。且沿叶轮21的径向方向上，各导流孔2113位于第一安装槽2111与第二安装槽2112之间。
进一步地，叶轮21上的导流孔2113为多个，多个导流孔2113环绕叶轮21的旋转轴均匀间隔分布，且每个导流孔2113的一个开口朝向出液口12，另一个开口与限位槽322相对。
在图示的实施例中，导流孔2113为四个，四个导流孔2113具体是开设于轮毂211上。需要说明的是，导流孔2113不限于为四个，导流孔2113也可以为一个、两个、三个或者是多于四个，导流孔2113的数量可以根据具体需要进行设置。
进一步地，请参与图6及图15，第一安装槽2111包括直孔部2111a及与直孔部2111a连通的斜孔部2111b，斜孔部2111b的孔径沿远离直孔部2111a的方向逐渐增大，斜孔部2111b与限位槽322相对，导流孔2113的远离出液口12的开口位于斜孔部2111b的侧壁上；传动轴22的远离限位槽322的一端收容于斜孔部2111b和直孔部2111a，并与直孔部2111a的侧壁固接。如此，当传动轴22安装于第一安装槽2111之后，传动轴22与斜孔部2111b的内壁之间设有第三间隙，从限位槽322流出的灌注液可直接从第三间隙进入导流孔2113中，也即是斜孔部2111b的倾斜内壁起到导流的作用，快速引导灌注液或血液进入导流孔2113中，形成二次流场。
在本申请的另一个实施例中，孔组件324与限位槽322的连接方式也可以为其他方式，如图16所示，限位槽322的槽壁为圆柱面，孔组件324包括第一孔3241和多个第二孔3242，第一孔3241和多个第二孔3242均连通注液筒40与限位槽322，第一孔3241与传动轴22的远离叶轮21的一端的端面相对设置，多个第二孔3242环绕第一孔3241的中心线间隔且均匀地设置一周。具体地，多个第二孔3242位于限位槽322的侧壁上，多个第二孔3242则与传动轴22的周侧相对，这样，通过多个第二孔3242的设置，从而能够将灌注液导入限位槽322中并分别作用于传动轴22的周侧上，从而实现传动轴22的径向平衡。
以上仅为本申请的可选实施例而已，并不用于限制本申请。对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的权利要求范围之内。

Claims (20)

  1. 一种介入式心室辅助装置，包括介入管、电机组件、注液筒及叶轮组件，其中：
    所述介入管具有进液口及出液口；
    所述叶轮组件包括叶轮，所述叶轮收容于所述介入管中，所述叶轮能够旋转以使液体能够从所述进液口进入所述介入管，并从所述出液口流出；
    所述电机组件能够产生旋转磁场以驱动所述叶轮旋转，所述电机组件能够对所述叶轮产生吸引力；
    所述注液筒能够供灌注液注入所述介入管，且经所述注液筒注入的所述灌注液能够给所述叶轮组件提供一推力，以使所述叶轮能够在所述推力及所述吸引力的共同作用下悬浮旋转于所述介入管中。
  2. 如权利要求1所述的介入式心室辅助装置，其特征在于，所述电机组件具有限位槽，所述限位槽与所述介入管连通，所述注液筒中的灌注液能够注入所述限位槽中，并能够从所述限位槽注入所述介入管中；
    所述叶轮组件还包括传动轴，所述传动轴的一端与所述叶轮固接，另一端延伸至所述限位槽中，所述传动轴能够随所述叶轮旋转，且所述传动轴的远离所述叶轮的一端能够在所述电机组件对所述叶轮的吸引力和所述灌注液的推力的共同作用下悬浮于所述限位槽中。
  3. 如权利要求2所述的介入式心室辅助装置，其特征在于，所述电机组件还包括孔组件，所述孔组件与所述限位槽连通，所述注液筒与所述孔组件连通，所述注液筒中的灌注液能够依次经过所述孔组件、所述限位槽而注入所述介入管中；
    所述孔组件与所述传动轴的远离所述叶轮的一端相对，以使经所述孔组件注入所述限位槽中的灌注液能够给所述传动轴提供推力，所述传动轴和所述叶轮能够在所述电机组件和所述灌注液的共同作用下悬浮旋转。
  4. 如权利要求3所述的介入式心室辅助装置，其特征在于，所述限位槽具有槽口及与所述槽口相对的底壁，所述槽口与所述介入管连通；所述传动轴穿设于所述槽口，所述传动轴的远离所述叶轮的一端的端面为外凸的半球面状；
    所述孔组件包括第一孔和多个第二孔，所述第一孔和多个所述第二孔均位于所述底壁上，所述第一孔和多个所述第二孔均连通所述注液筒与所述限位槽，所述第一孔与所述传动轴的远离所述叶轮的一端的端面中心相对，多个所述第二孔环绕所述第一孔等间距地设置一周，且多个所述第二孔均与所述传动轴的远离所述叶轮的一端的端面相对。
  5. 如权利要求4所述的介入式心室辅助装置，其特征在于，所述限位槽的所述底壁呈内凹的半球面状，所述第一孔位于所述底壁的中心。
  6. 如权利要求3所述的介入式心室辅助装置，其特征在于，所述限位槽的槽壁为圆柱面，所述孔组件包括第一孔和多个第二孔，所述第一孔和多个所述第二孔均连通所述注液筒与所述限位槽，所述第一孔与多个所述第二孔均与所述传动轴的远离所述叶轮的一端相对，所述第一孔与所述传动轴的远离所述叶轮的一端的端面相对，多个所述第二孔环绕所述第一孔间隔且均匀地设置一周。
  7. 如权利要求3所述的介入式心室辅助装置，其特征在于，所述孔组件包括多个第一孔，多个所述第一孔均与所述传动轴的远离所述叶轮的一端的端面相对，且多个所述第一孔环绕所述传动轴的旋转轴线均匀且间隔设置。
  8. 如权利要求3所述的介入式心室辅助装置，其特征在于，所述电机组件包括机壳及密封安装于所述机壳内的定子，所述机壳与所述介入管、所述注液筒均密封连接，所述机壳设置在所述介入管的一端，所述出液口设于所述介入管的靠近所述机壳的一端，所述注液筒位于所述机壳的远离所述介入管的一侧，所述限位槽与所述孔组件均开设于所述机壳。
  9. 如权利要求8所述的介入式心室辅助装置，其特征在于，所述定子与所述叶轮沿所述叶轮的旋转轴线设置。
  10. 如权利要求8所述的介入式心室辅助装置，其特征在于，所述机壳开设有环形槽，所述环形槽环绕所述限位槽设置，并与所述限位槽间隔，所述定子收容于所述环形槽中。
  11. 如权利要求10所述的介入式心室辅助装置，其特征在于，所述环形槽的中心延伸有柱体，所述限位槽及所述孔组件均形成于所述柱体；所述柱体与所述环形槽同心设置，所述柱体的一端向所述环形槽外部延伸，所述柱体伸出所述环形槽的一端收容于所述注液筒。
  12. 如权利要求8所述的介入式心室辅助装置，其特征在于，在所述机壳与所述介入管的连接处，所述机壳的外壁和所述介入管的外壁平齐，在所述机壳与所述注液筒的连接处，所述机壳的外壁和所述注液筒的外壁平齐。
  13. 如权利要求3所述的介入式心室辅助装置，其特征在于，所述介入管具有第一通道，所述第一通道分别与所述进液口及所述出液口连通，所述叶轮收容于所述第一通道中；
    所述注液筒开设有第二通道，经所述注液筒注入的灌注液能够依次经过所述第二通道、所述孔组件、所述限位槽注入所述第一通道中。
  14. 如权利要求2所述的介入式心室辅助装置，其特征在于，所述叶轮包括轮毂及设置在所述轮毂中的磁性件，所述轮毂上形成有第一安装槽及第二安装槽，所述第二安装槽呈环形并围设于所述第一安装槽外，所述传动轴的远离所述限位槽的一端收容于所述第一安装槽，所述磁性件收容于所述第二安装槽。
  15. 如权利要求2所述的介入式心室辅助装置，其特征在于，所述叶轮上开设有导流孔，所述导流孔具有两个开口，所述导流孔的一个所述开口朝向所述出液口，另一个所述开口与所述限位槽相对。
  16. 如权利要求15所述的介入式心室辅助装置，其特征在于，所述叶轮上开设有多个所述导流孔，多个所述导流孔环绕所述叶轮的旋转轴均匀间隔分布，且每个所述导流孔的一个所述开口朝向所述出液口，另一个所述开口与所述限位槽相对。
  17. 如权利要求15所述的介入式心室辅助装置，其特征在于，所述叶轮上还开设有第一安装槽，所述第一安装槽包括直孔部及与所述直孔部连通的斜孔部，所述斜孔部的孔径沿远离所述直孔部的方向逐渐增大，所述斜孔部与所述限位槽相对，所述导流孔的远离所述出液口的所述开口位于所述斜孔部的侧壁上；所述传动轴的远离所述限位槽的一端收容于所述斜孔部和所述直孔部，并与所述直孔部的侧壁固接。
  18. 如权利要求2所述的介入式心室辅助装置，其特征在于，所述传动轴位于所述叶轮的旋转轴线上，且所述传动轴的延伸方向与所述叶轮的旋转轴线一致。
  19. 如权利要求1所述的介入式心室辅助装置，其特征在于，所述电机组件连接于所述介入管与所述注液筒之间，所述叶轮包括圆柱段、锥状段、磁性件和叶片，所述圆柱段与所述锥状段沿所述叶轮的轴向一体连接；所述圆柱段靠近所述电机组件设置，所述锥状段远离所述电机组件设置，所述磁性件安装于所述圆柱段，所述叶片固接于所述锥状段的外壁上。
  20. 如权利要求1所述的介入式心室辅助装置，其特征在于，所述介入管包括直管段及与所述直管段的一端弯折延伸的弯管段，所述直管段的远离所述弯管段的一端与所述电机组件固接，所述出液口位于所述弯管段的远离所述直管段的一端，所述出液口位于所述直管段的远离所述弯管段的一端的管壁上，所述叶轮能够旋转地收容于所述直管段。
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