WO2017133427A1 - 心脏辅助装置 - Google Patents

心脏辅助装置 Download PDF

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Publication number
WO2017133427A1
WO2017133427A1 PCT/CN2017/071197 CN2017071197W WO2017133427A1 WO 2017133427 A1 WO2017133427 A1 WO 2017133427A1 CN 2017071197 W CN2017071197 W CN 2017071197W WO 2017133427 A1 WO2017133427 A1 WO 2017133427A1
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WO
WIPO (PCT)
Prior art keywords
outflow
assist device
inflow
end surface
length
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PCT/CN2017/071197
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English (en)
French (fr)
Inventor
丁以群
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丁以群
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Publication of WO2017133427A1 publication Critical patent/WO2017133427A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • A61M60/863—Apex rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • A61M60/242—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps with the outlet substantially perpendicular to the axis of rotation
    • 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
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/416—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted directly by the motor rotor drive shaft
    • 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor speed
    • 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/876—Implantable batteries

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a cardiac assist device.
  • the current common solution is to perform Fontan surgery.
  • the basic principle is to use the pressure difference between the body vein and the pulmonary artery to guide the vena cava blood to bypass the functional right ventricle and directly enter the pulmonary circulation and return to the left.
  • the purpose of separating the venous blood from the arterial blood and allowing the venous blood to flow through the lungs for oxygenation is achieved.
  • this objective due to the lack of right ventricular pressure during blood flow after Fontan surgery, this objectively requires pulmonary vascular resistance to be less than 6 wood/m2.
  • the technical problem to be solved by the present invention is to provide a cardiac assist device having a right ventricular replacement function.
  • Providing a cardiac assist device comprising:
  • the communication duct includes a first inflow portion, a second inflow portion, an outflow portion, and a confluence portion that communicate with each other, and the confluence portion penetrates the first inflow portion and the second inflow portion and communicates with the outflow portion.
  • the outflow portion includes a connecting end surface connecting the confluence portion, and a center perpendicular of the connecting end surface is a first vertical line a line, a center perpendicular of the outflow end surface is a second perpendicular line, and the first vertical line intersects the second perpendicular line;
  • a blade rotatably coupled to the interior of the outflow portion for propelling fluid in the communication conduit from the outflow end surface of the outflow portion;
  • the driving device is located outside the outflow portion, the outflow portion includes a bottom wall disposed opposite to the outflow end surface, and the blade and the driving device are respectively located at two sides of the bottom wall
  • the driving device is used to drive the blades to rotate.
  • a center perpendicular of the inflow end surface of the first inflow portion is a third perpendicular line
  • a center perpendicular of the inflow end surface of the second inflow portion is a fourth perpendicular line
  • the third perpendicular line and the first The four vertical lines are collinear.
  • first perpendicular line forms an angle of 70° to 110° with the second perpendicular line
  • first perpendicular line intersects the third perpendicular line and forms an angle of 80° to 100°.
  • the length of the connecting end face is a first length
  • the length of the outflow portion is a second length
  • the second length is greater than or equal to twice the first length in a direction perpendicular to the outflow end surface.
  • the length of the blade is a third length, and the third length is greater than or equal to twice the first length and less than the second length.
  • the blade includes a first end adjacent to the bottom wall, a distance between the first end and the bottom wall is a fourth length, and the fourth length is smaller than the first length.
  • the cardiac assist device further comprises:
  • first inflow pipe being detachably connected to the first inflow portion
  • An outflow tube detachably connected to the outflow portion.
  • the first inflow pipe includes a first circulation portion and a first connection portion for connecting the first inflow portion
  • the second inflow pipe includes a second circulation portion and a connection for connecting the second inflow portion a second connecting portion
  • the outflow pipe includes a third flow portion and a third connecting portion for connecting the outflow portion, and materials of the first connecting portion, the second connecting portion, and the third connecting portion
  • the material is a hard material
  • the materials of the first flow portion, the second flow portion, and the third flow portion are all flexible materials.
  • the material of the connecting pipe is titanium metal.
  • the cardiac assisting device further includes a support frame and a rotating shaft disposed in the outflow portion, the support frame is fixed on an inner wall of the outflow portion, and includes a first bracket and a second branch disposed opposite to each other a blade, the blade is disposed around the rotating shaft, an axis of the rotating shaft is perpendicular to the outflow end surface, and the rotating shaft is rotatably connected between the first bracket and the second bracket.
  • the heart assist device further comprises a sewing ring connected to the outer wall of the confluence.
  • the sewing ring is located at an end of the confluence portion close to the outflow portion.
  • the driving device includes a motor and a controller, the motor is configured to drive the blade to rotate, and the controller is electrically connected to the motor to adjust an output power of the motor;
  • the cardiac assist device further includes a partition wall fixed to a side of the bottom wall facing away from the outflow end surface and forming an isolation cavity together with the bottom wall, the motor being located inside the isolation chamber .
  • the cardiac assist device further includes a first battery component and a second battery component
  • the first battery component is electrically connected to the motor to provide electrical energy to the motor;
  • the second battery component wirelessly charges the first battery component.
  • the first battery component includes an electrically connected first battery and a first charging interface, the first battery electrically connecting the motor;
  • the second battery assembly includes an electrically connected second battery and a second charging interface, and the second charging interface is wirelessly connected to the first charging interface to transfer electrical energy in the second battery to the The first battery.
  • the cardiac assist device further comprises a sensing device and a signal processing device
  • the sensing device is configured to detect a fluid parameter in the communication conduit and form a first signal to be transmitted to the signal processing device;
  • the signal processing device is configured to receive, store, and process the first signal and form a second signal to the controller to cause the controller to adjust an output power of the motor.
  • the signal processing device comprises a chip and a processor
  • the chip transmits raw data to the processor
  • the processor receives the raw data, forms feedback data, and transmits the feedback signal to the chip;
  • the processor includes a display screen for displaying the raw data and/or the feedback data.
  • the present invention has the following beneficial effects:
  • the cardiac assist device of the present invention can provide an alternative right ventricle for a patient with a single ventricular physiology, and includes an alternative flow path and driving force for pumping the venous blood into the pulmonary artery. Meanwhile, since the first vertical line intersects the second vertical line, when the patient's blood flows in the outflow portion, the flow direction of the blood is always in the same plane, and the flow path is short, so that the driving device The efficiency is high and the energy consumption is small, that is, the energy consumption of the cardiac assist device is reduced.
  • the cardiac assisting device may, when installed, place the outflow portion in a patient's heart chamber, the first inflow portion and the second inflow portion being placed outside the heart, the confluence portion and the patient's atrium
  • the side walls are stitched to secure the heart assist device.
  • the installation of the cardiac assisting device only needs to cut a small opening in the side wall of the patient's atrium, and then suture it, and hardly damage the heart tissue of the patient, thereby avoiding the normal work of affecting other functions of the original heart.
  • the communication duct is provided with only the outflow portion as its single outflow path, pulmonary blood flow homology can be achieved.
  • FIG. 1 is a schematic structural diagram of a cardiac assist device according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural view of a communication pipe of a cardiac assist device according to an embodiment of the present invention.
  • FIG 3 is a top plan view of a communication conduit of a cardiac assist device according to an embodiment of the present invention.
  • Figure 4 is an enlarged schematic view showing the structure of A in Figure 1.
  • Figure 5 is an enlarged schematic view showing the structure of B in Figure 1.
  • FIG. 6 is a schematic structural view of components in a communication pipe of a cardiac assist device according to an embodiment of the present invention.
  • FIG. 7 is another schematic structural diagram of a component of a communication conduit of a cardiac assist device according to an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of a signal transmission process of a cardiac assist device according to an embodiment of the present invention.
  • an embodiment of the present invention provides a cardiac assist device including a communication duct 1, a blade 2, and a driving device 3.
  • the communication duct 1 includes a first inflow portion 11 , a second inflow portion 12 , an outflow portion 14 , and a confluence portion 13 that communicate with each other, and the confluence portion 13 penetrates the first inflow portion 11 and the second inflow portion 12 .
  • the outflow portion 14 includes a connecting end surface 142 that connects the confluence portion 13.
  • the center perpendicular of the connecting end surface 142 is a first vertical line 1420, and the center perpendicular of the outflow end surface 140 is a second vertical line 1400.
  • the first vertical line 1420 intersects the second vertical line 1400.
  • the vane 2 is rotatably coupled to the inside of the outflow portion 14 for propelling fluid in the communication duct 1 from the outflow end surface 140 of the outflow portion 14.
  • the driving device 3 is located outside the outflow portion 14, and the outflow portion 14 includes a bottom wall 141 disposed opposite to the outflow end surface 140, and the blade 2 and the driving device 3 are respectively located at the bottom wall 141. On both sides, the driving device 3 is used to drive the blade 2 to rotate.
  • the first inflow portion 11 of the communication duct 1 communicates with the superior vena cava of the patient
  • the second inflow portion 12 communicates with the inferior vena cava of the patient
  • the outflow portion 14 communicates with the pulmonary artery of the patient.
  • the driving device 3 drives the blade 2 to rotate, and the superior vena cava blood and the inferior vena cava blood of the patient flow into the communication duct 1 from the first inflow portion 11 and the second inflow portion 12, Under the pushing and pressurization of the blade 2, the communication duct 1 flows out from the outflow portion 14 and flows into the pulmonary artery of the patient.
  • the cardiac assist device of the present embodiment can provide an alternative right ventricle for a patient with a single ventricular physiology, and includes an alternative flow path and driving force for pumping the blood of the body vein into the pulmonary artery. Furthermore, since the first vertical line 1420 intersects the second vertical line 1400, when the patient's blood flows in the outflow portion 14, the flow direction of the blood is always in the same plane, and the flow path is short.
  • the driving device 3 is made highly efficient and consumes less energy, that is, the energy consumption of the cardiac assist device is reduced.
  • the heart assist device may be configured to place the outflow portion 14 in a patient's heart chamber when installed, the first inflow portion 11 and the second inflow portion 12 being placed outside the heart, the confluence The portion 13 is sutured to the patient's atrial sidewall to secure the cardiac assist device.
  • the installation of the cardiac assisting device only needs to cut a small opening in the side wall of the patient's atrium, and then suture it, and hardly damage the heart tissue of the patient, thereby avoiding the normal work of affecting other functions of the original heart.
  • the communication duct 1 is provided with only the outflow portion 14 as its single outflow path, pulmonary blood flow homology can be achieved.
  • the blade 2 and the driving device 3 are respectively disposed on two sides of the bottom wall 141, that is, the bottom wall 141 is completely separated.
  • the driving device 3 and the blade 2, the driving device 3 wirelessly drives the blade 2 to rotate.
  • the wireless driving such as electromagnetic driving, etc.
  • the present embodiment can be designed with reference to the achievable wireless driving mode, and is not described here.
  • connection end face in the embodiment of the present invention can be understood as the plane in which the inflow port of the outflow portion 14 is located.
  • a surface having a smallest flow area in the confluence portion 13 among a plurality of planes of the junction region of the confluence portion 13 and the outflow portion 14 is defined as the connection end surface.
  • the center perpendicular of the inflow end surface 110 of the first inflow portion 11 is a third perpendicular line 111
  • the center perpendicular of the inflow end surface 120 of the second inflow portion 12 For the fourth perpendicular line 121, the third vertical line 111 and the fourth vertical line 121 are collinear.
  • the third vertical line 111 is collinear with the fourth vertical line 121, the connection between the first inflow portion 11 and the second inflow portion 12 and the confluence portion 13 is also made. It is not easy to generate a vortex, and the energy loss of the fluid in the communication pipe 1 is reduced. And the communication conduit 1 is half placed in the patient's heart cavity, so the flow of the patient's blood from the superior vena cava and the inferior vena cava to the inflowing pulmonary artery is the shortest, and the flow trajectory is closest to the healthy heart, and the blade 2 only needs to be applied to the blood. A small driving force can push its flow, making the driving device 3 highly efficient, consumes less energy, and also reduces the energy consumption of the heart assist device.
  • the volume of the confluence portion 13 penetrating the first inflow portion 11 and the second inflow portion 12 may be set to be relatively short, and the first inflow portion 11 and the second inflow portion 12 are substantially In the same plane, the communication pipe 1 of the cardiac assisting device has a small overall volume, is convenient to install, and has a wide application range.
  • central vertical line refers to a line located at the center of the designated plane and perpendicular to the designated plane.
  • first vertical line 1420 is the center perpendicular of the connecting end surface 142, that is, located at the center.
  • the connecting end surface 142 is centered and perpendicular to the line connecting the end surface 142;
  • the second vertical line 1400 is a central perpendicular of the outflow end surface 140 of the outflow portion 14, that is, at the center of the outflow end surface 140 and a line perpendicular to the outflow end surface 140;
  • the third vertical line 111 is a center perpendicular to the inflow end surface 110 of the first inflow portion 11, that is, at the center of the inflow end surface 110 of the first inflow portion 11 And perpendicular to the line of the inflow end surface 110 of the first inflow portion 11;
  • the fourth perpendicular line 121 is a center perpendicular to the outflow end surface 140 of the second inflow portion 12, that is, the second inflow
  • the outflow end face 140 of the portion 12 is centered and perpendicular to the line of the outflow end face 140 of the second inflow portion 12.
  • the first vertical line 1420 forms an angle ⁇ with the second vertical line 1400 of 70° to 110°
  • the first vertical line 1420 and the third The vertical lines 111 intersect and form an angle ⁇ of 80° to 100°.
  • the communication duct 1 forms a flow path similar to an inverted "h" type, and when the communication duct 1 is installed in a patient, the inverted "h" type flow path does not damage the heart physiological curve of the patient.
  • the shape of the flow channel is similar to the blood flow trajectory at the right ventricle of the healthy heart, helping to reduce the energy consumption of the drive device 3, even if the heart assist device is more efficient and energy efficient.
  • the shape of the communication duct 1 includes, but is not limited to, the case described in the above embodiment, and the third vertical line 111 and the second vertical line should be flexibly designed according to the heart condition of the patient.
  • the first inflow portion 11 and the second inflow portion 12 may also be twisted relative to the outflow portion 14 to accommodate the heart shape of the patient.
  • the first vertical line 1420 forms an angle ⁇ of 90° with the second vertical line 1400
  • the first vertical line 1420 intersects the third vertical line 111 and forms an angle ⁇ of 90°.
  • the first perpendicular line 1420 forms an angle with the third perpendicular line 111 of less than 45°; or the first perpendicular line 1420 is coplanar with the third perpendicular line 111 and is parallel to each other or forms a ratio of 30° or less. Sharp angle.
  • the length of the connecting end surface 142 is a first length L1
  • the length of the outflow portion 14 is a second length L2.
  • the second length L2 is greater than or equal to twice the first length L1 such that the fluid in the communication duct 1 is sufficiently pressurized in the outflow portion 14.
  • the length of the blade 2 in a direction perpendicular to the outflow end surface 140 is a third length L3, and the third length L3 is greater than or equal to twice the number. a length L1, and the third length L3 is less than or equal to the second length L2 such that the blade 2 has A propulsion area long enough.
  • the third length L3 is greater than or equal to two-thirds of the second length L2, that is, the length of the outflow portion 14 only needs to be slightly greater than or equal to the length of the blade 2.
  • the blade 2 includes a first end 21 adjacent to the bottom wall 141, and a distance between the first end 21 and the bottom wall 141 is a fourth length. L4, the fourth length L4 is less than or equal to the first length L1. That is, the distance between the first end 21 and the bottom wall 141 is small, so that the energy consumption of the driving device 3 can be reduced.
  • the driving device 3 and the blade 2 are both close to the The bottom wall 141 is provided.
  • the blood in the communication duct 1 directly enters the propulsion area of the vane 2 from the confluence portion 13 (the rotation area of the vane 2 is its propulsion area), the flow of the fluid is reduced, and the The fluid resistance, the energy consumption of the drive device 3 is reduced, and the efficiency of the heart assist device is increased.
  • the cardiac assist device further includes a first inflow tube 011 , a second inflow tube 012 , and an outflow tube 014 .
  • the first inflow pipe 011 is detachably connected to the first inflow portion 11
  • the second inflow pipe 012 is detachably connected to the second inflow portion 12
  • the outflow pipe 014 is detachably connected to the outflow portion 14.
  • the first inflow pipe 011 includes a first circulation portion and a first connection portion for connecting the first inflow portion 11
  • the second inflow pipe 012 includes a second circulation portion and is used for connection
  • the outflow tube 014 includes a third flow portion and a third connecting portion for connecting the outflow portion 14.
  • the materials of the first connecting portion, the second connecting portion and the third connecting portion are all hard materials to facilitate connection.
  • the materials of the first flow portion, the second flow portion, and the third flow portion are all flexible materials, and can be adapted to different blood vessel anatomy of different patients.
  • the first connecting portion is detachably connected to the inflow end surface 110 of the first inflow portion 11, and the second connecting portion is detachably connected to the inflow end surface 120 of the second inflow portion 12,
  • the third connecting portion is detachably connected to the outflow end surface 140 of the outflow portion 14.
  • the detachable connection refers to a detachable connector for connection, such as a key connection, a pin connection, a screw connection, and a clamp connection.
  • the outer wall of the first inflow portion 11 is disposed at a position adjacent to the inflow end surface thereof (that is, the first connecting portion) is provided with a groove 113, the first flow
  • the inner wall of one end of the inlet pipe 011 is provided with a protrusion 0113, and the protrusion 0113 is caught in the groove 113 to form a connecting piece.
  • a fastening ring 114 is provided on the connector to fix the first inflow pipe 011 to the communication pipe 1.
  • the heart assist device further includes a sewing ring 4 connected to an outer wall of the confluence portion 13 .
  • the inner ring of the sewing ring 4 is stitched or ferred on the confluence portion 13, and the outer ring of the sewing ring 4 is used for sewing to the atrial side wall, thereby fixing the confluence portion 13 of the communication pipe 1 To the heart.
  • the sewing ring 4 employs a biocompatible, non-absorbable woven material, such as polyester that can be used for stitching.
  • a biocompatible, non-absorbable woven material such as polyester that can be used for stitching.
  • a position of the outer wall of the confluence portion 13 near the connecting end surface 142 is provided with a recessed area 131 , and the sewing ring 4 is engaged with the recess.
  • the fixing of the confluence portion 13 is achieved in the region 131.
  • the material of the communication pipe 1 is set to be a hard material, that is, the communication pipe 1 is in the fluid. No deformation or very slight deformation occurs under pressure, thereby enabling fluid to flow along a predetermined flow path trajectory to reduce energy consumption of the cardiac assist device.
  • the connecting pipe 1 can be made of lightweight titanium, which has high strength, small density, high hardness, high melting point, strong corrosion resistance and good biocompatibility.
  • the material of the first inflow pipe 011, the second inflow pipe 012, and the outflow pipe 014 is preferably a flexible material (for example, an artificial blood vessel).
  • a coating may be applied on the surface of the communication conduit 1, which uses an antithrombotic substance to reduce the formation of blood clots.
  • the coating may be coated with a polytetrafluoroethylene.
  • the cardiac assist device further includes a support frame 143 and a rotating shaft 22 disposed in the outflow portion 14 , and the support frame 143 is fixed to the outflow portion.
  • An inner wall of the first wall 144 and a second bracket 145, the blade 2 is disposed around the rotating shaft 22, and the axis 221 of the rotating shaft 22 is perpendicular to the outflow end surface 140 (preferably, The axis is collinear with the second vertical line 1400), and the rotating shaft 22 is rotatably coupled between the first bracket 144 and the second bracket 145.
  • the axis 221 of the rotating shaft 22 is perpendicular to the outflow end surface 140, that is, the propulsion force direction of the blade 2 is perpendicular to the outflow end surface 140, and the fluid of the communication pipe 1 is small.
  • the propulsive force of the blade 2 can be smoothly ejected from the outflow end face 140, so that the cardiac assist device consumes less energy and is more energy-saving.
  • the shape of the blade 2 can be rationally designed. It is made to have greater propulsive force while reducing the impact of blood flow on the side walls of the outflow portion 14 to reduce losses.
  • the first bracket 144 includes a first ring portion 1441 and a first spoke 1442 , and the first spoke 1442 is disposed on the first ring portion.
  • a first groove 1443 is disposed at a middle portion of the first spoke 1442;
  • the second bracket 145 includes a second ring portion 1451 and a second spoke 1452, the second The spokes 1452 are disposed at positions of any one of the diameters of the inner circumference of the second ring portion 1451, and the second portion of the second spokes is provided with a second groove 1453.
  • the support frame 143 further includes a positioning bracket 146 that connects the first bracket 144 and the second bracket 145 for fixing between the first bracket 144 and the second bracket 145. spacing.
  • a maximum distance between the first groove 1443 and the second groove 1453 is greater than a total length of the rotating shaft 22, the first groove 1443 and The minimum spacing between the second grooves 1453 (for example, between the edges of the two grooves) is smaller than the total length of the rotating shaft 22, so that the rotating shaft 22 has a slight relative movement space, so that the rotating shaft 22 And the blade 2 has a certain self-adjusting space during rotation or operation, which is beneficial to the rotation of the rotating shaft 22 and the blade 2 according to the flow of the fluid in the communication pipe 1, and has the ability of buffering and optimization.
  • the blade 2 and the rotating shaft 22 are both made of a hard material, preferably a lightweight titanium metal material.
  • the shaft 22 is hollow to reduce the mass and reduce the energy consumption of the driving device 3.
  • the driving device 3 of the cardiac assist device includes a motor 5 and a controller 6 for driving the blade 2 to rotate; the controller 6
  • the motor 5 is electrically connected to regulate the output power of the motor 5.
  • the motor 5 and the blade 2 are respectively disposed on two sides of the bottom wall 141, that is, the bottom wall 141 completely separates the motor 5 from the blade 2,
  • the motor 5 wirelessly drives the blade 2 to rotate.
  • the wireless driving such as electromagnetic driving, etc.
  • the present embodiment can be designed with reference to the achievable wireless driving mode, and is not described here.
  • the spacing between the motor 5 and the blade 2 should be as small as possible to reduce the energy consumption of the motor 5.
  • the motor 5 and the blade 2 are disposed adjacent to the bottom wall 141.
  • the heart assist device further includes a partition wall 51 fixed to a side of the bottom wall 141 facing away from the outflow end surface 140 , and An isolation chamber 50 is formed in conjunction with the bottom wall 141, and the motor 5 is placed within the isolation chamber 50.
  • the controller 6 is also placed within the isolation chamber 50.
  • the isolation chamber 50 is a sealed chamber.
  • the partition wall 51 is also built into the heart when the heart assist device is mounted to a human body. The partition wall 51 connects the motor 5 and the controller 6 with The blood in the heart is isolated, which improves the biocompatibility of the cardiac assist device, while ensuring that the motor 5 and the controller 6 have a good use environment and improve their service life.
  • the communication pipe 1 and the partition wall 51 are designed in a transitional design such as a circular arc or a slope, so as to avoid the use of a right angle or a protruding portion to prevent formation. thrombus.
  • the cardiac assist device further includes a first battery component 71 and a second battery component 72.
  • the first battery assembly 71 is electrically connected to the motor 5 for supplying electric power to the motor 5.
  • the second battery component 72 wirelessly charges the first battery component 71.
  • the first battery component 71 includes a first battery 711 electrically connected to the first charging interface 712, and the first battery 711 is electrically connected to the motor 5.
  • the second battery assembly 72 includes a second battery 721 and a second charging interface 722 that are electrically connected. The first charging interface 712 and the second charging interface 722 are wirelessly connected to transfer the electrical energy in the second battery 721 to the first battery 711.
  • the first battery assembly 71 When the cardiac assist device is mounted to a human body, the first battery assembly 71 is placed in the body and the second battery assembly 72 is placed outside the body.
  • the first battery assembly 71 is connected to the motor 5 by wires, and the first battery assembly 71 is placed outside the heart and buried under the skin (bath is preferred).
  • the second battery assembly 72 is disposed on a waist belt, and the second battery assembly 72 faces the first battery assembly 71 after the user wears the belt.
  • the second battery component 72 wirelessly charges the second battery component 72, and the wireless charging reference may be implemented by a wireless charging mode.
  • the cardiac assist device further includes a sensing device 100 and a signal processing device 101 .
  • the sensing device 100 is configured to detect the communication pipe 1
  • the fluid parameters are internal and form a first signal S1 that is transmitted to the signal processing device 101.
  • the signal processing device 101 is configured to receive, store, and process the first signal S1, and form a second signal S2 to be transmitted to the controller 6, so that the controller 6 adjusts the output power of the motor 5.
  • the fluid parameters described in this embodiment include, but are not limited to, pressure, viscosity, flow rate, temperature, density, and the like.
  • the sensing device 100 may be provided with multiple sensors at the same time to detect a plurality of different parameters, or multiple sensors installed at multiple positions of the communication pipe 1 to detect the same parameter of a plurality of different positions. . Further, the sensing device 100 can simultaneously detect the operating parameters of the blade 2 and/or the motor 5, such as the rotational speed, power, etc., while transmitting relevant data to the signal processing device 101 to obtain more The ideal second signal S2 increases the operating efficiency of the motor 5 and reduces the energy consumption of the heart assist device. Of course, the sensing device 100 can also detect other parameters according to specific needs.
  • the signal processing device 101 of the cardiac assist device includes a chip 81 and a processor 82 .
  • the chip 81 transmits raw data S3 to the processor 82.
  • the processor 82 receives the raw data S3, forms feedback data S4, and transmits the feedback data S4 to the chip 81.
  • the processor 82 includes a display screen 821 for displaying the raw data S3 and/or the feedback data S4.
  • the chip 81 and the processor 82 both have signal processing capabilities, and the processor 82 further has the ability to modify the internal data/program of the chip 81 to cause the signal processing device 101.
  • the cardiac assist device is adapted to meet the patient's real-time physiological state, and the battery life time can be extended and the cardiac assist device can be extended. The service life and so on.
  • the display screen 821 in the embodiment can intuitively express the physical condition of the user and the working state of the cardiac assisting device, and is useful for diagnosing and treating the user.
  • the controller 6 and the chip 81 are placed in the body.
  • the chip 81 is connected to the controller 6 through a data line, and the first chip 81 is placed outside the heart and buried under the skin (bath is preferred).
  • the processor 82 can be integrally disposed on a belt provided with a second battery assembly 72, and the processor 82 faces the chip 81 after the user wears the belt.
  • the processor 82 wirelessly transmits data to the chip 81 in both directions.
  • the display screen 821 can be disposed on the outer surface of the waistband, and the user can directly view Look at the display image of the display screen 821.

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Abstract

一种心脏辅助装置，包括：连通管道(1)、叶片(2)及驱动装置(3)，连通管道(1)包括彼此连通的第一流入部(11)、第二流入部(12)、流出部(14)以及汇流部(13)，所述汇流部(13)贯通所述第一流入部(11)与所述第二流入部(12)并连通至所述流出部(14)，所述流出部(14)包括流出端面(140)和连接所述汇流部(13)的连接端面(142)，所述连接端面(142)的中心垂线与所述流出端面(140)的中心垂线相交；叶片(2)转动连接至所述流出部(14)的内部，用以推进所述连通管道(1)内的流体从所述流出部(14)的流出端面(140)流出；驱动装置(3)位于所述流出部(14)的外部，所述流出部(14)包括与所述流出端面(140)相对设置的底壁(141)，所述叶片(2)与所述驱动装置(3)分别位于所述底壁(141)的两侧，所述驱动装置(3)用以驱动所述叶片(2)转动。所述心脏辅助装置具有右心室替代功能。

Description

心脏辅助装置
本发明要求2016年2月2日递交的发明名称为“心脏辅助装置”的申请号201610074468.4的在先申请优先权，上述在先申请的内容以引入的方式并入本文本中。
技术领域
本发明涉及医疗器械技术领域，特别涉及一种心脏辅助装置。
背景技术
对于单心室生理性疾病，目前常用的解决方案为进行Fontan类手术，其基本原理是利用体静脉与肺动脉之间的压力差，引导腔静脉血绕开功能性右心室直接进入肺循环并回流到左心房，达到了使静脉血与动脉血分开、并使静脉血流经肺部进行氧合的目的。但是由于Fontan手术后，血液流动过程中缺少右心室的加压过程，这就在客观上要求肺血管阻力必须低于6wood/m2。然而，一部分患者在生命的早期就出现了肺血管阻力升高的情况，使得这部分病人不可以施行Fontan手术；另外一些患者虽然接受了Fontan手术，但随着年龄的升高，肺血管阻力逐步增加，最终容易出现循环衰竭。对于这两类人群，目前唯一的治疗方法就是心脏移植。但事实上，此类患者的左心功能可能还处于理想状态，移植的目的仅仅是提供一个“右心室”。
发明内容
本发明所要解决的技术问题在于提供一种具有右心室替代功能的心脏辅助装置。
为了实现上述目的，本发明实施方式采用如下技术方案：
提供一种心脏辅助装置，包括：
连通管道，包括彼此连通的第一流入部、第二流入部、流出部以及汇流部，所述汇流部贯通所述第一流入部与所述第二流入部并连通至所述流出部，所述流出部包括连接所述汇流部的连接端面，所述连接端面的中心垂线为第一垂 线，所述流出端面的中心垂线为第二垂线，所述第一垂线与所述第二垂线相交；
叶片，转动连接至所述流出部的内部，用以推进所述连通管道内的流体从所述流出部的流出端面流出；及
驱动装置，所述驱动装置位于所述流出部的外部，所述流出部包括与所述流出端面相对设置的底壁，所述叶片与所述驱动装置分别位于所述底壁的两侧，所述驱动装置用以驱动所述叶片转动。
其中，所述第一流入部的流入端面的中心垂线为第三垂线，所述第二流入部的流入端面的中心垂线为第四垂线，所述第三垂线和所述第四垂线共线。
其中，所述第一垂线与所述第二垂线形成70°至110°的角，所述第一垂线与所述第三垂线相交且形成80°至100°的角。
其中，在垂直于所述流出端面的方向上，所述连接端面长度为第一长度，所述流出部的长度为第二长度，所述第二长度大于等于二倍的所述第一长度。
其中，在垂直于所述流出端面的方向上，所述叶片的长度为第三长度，所述第三长度大于等于二倍的所述第一长度且小于所述第二长度。
其中，所述叶片包括靠近所述底壁的第一端，所述第一端与所述底壁之间的距离为第四长度，所述第四长度小于所述第一长度。
其中，所述心脏辅助装置还包括：
第一流入管，所述第一流入管可拆连接至所述第一流入部；
第二流入管，所述第二流入管可拆连接至所述第二流入部；及
流出管，所述流出管可拆连接至所述流出部。
其中，所述第一流入管包括第一流通部以及用于连接所述第一流入部的第一连接部，所述第二流入管包括第二流通部以及用于连接所述第二流入部的第二连接部，所述流出管包括第三流通部以及用于连接所述流出部的第三连接部，所述第一连接部、所述第二连接部以及所述第三连接部的材质均为硬质材料，所述第一流通部、所述第二流通部以及所述第三流通部的材质均为柔性材料。
其中，所述连通管道的材质为钛金属。
其中，所述心脏辅助装置还包括设置在所述流出部内的支撑架和转轴，所述支撑架固定在所述流出部的内壁，并且包括相对设置的第一支架和第二支 架，所述叶片围绕所述转轴设置，所述转轴的轴线垂直于所述流出端面，所述转轴转动连接在所述第一支架与所述第二支架之间。
其中，所述心脏辅助装置还包括缝合环，所述缝合环连接至所述汇流部的外壁。
其中，所述缝合环位于所述汇流部的靠近所述流出部的一端。
其中，所述驱动装置包括电机和控制器，所述电机用以驱动所述叶片转动，所述控制器电连接所述电机，用以调节所述电机的输出功率；
所述心脏辅助装置还包括隔离壁，所述隔离壁固定至所述底壁背离所述流出端面的一侧，并与所述底壁共同形成隔离腔，所述电机位于所述隔离腔的内部。
其中，所述心脏辅助装置还包括第一电池组件和第二电池组件；
所述第一电池组件电连接所述电机，用以为所述电机提供电能；
所述第二电池组件对所述第一电池组件进行无线充电。
其中，所述第一电池组件包括电连接的第一蓄电池和第一充电接口，所述第一蓄电池电连接所述电机；
所述第二电池组件包括电连接的第二蓄电池和第二充电接口，所述第二充电接口与所述第一充电接口之间无线连接，使所述第二蓄电池内的电能转移至所述第一蓄电池。
其中，所述心脏辅助装置还包括传感装置和信号处理装置；
所述传感装置用以检测所述连通管道内的流体参数，并形成第一信号传送至所述信号处理装置；
所述信号处理装置用以接收、存储以及处理所述第一信号，并形成第二信号传送至所述控制器，使所述控制器调节所述电机的输出功率。
其中，所述信号处理装置包括芯片和处理器；
所述芯片传送原始数据至所述处理器；
所述处理器接收所述原始数据、形成反馈数据，并传送所述反馈信号至所述芯片；
所述处理器包括显示屏，所述显示屏用以显示所述原始数据和/或所述反馈数据。
相较于现有技术，本发明具有以下有益效果：
本发明所述心脏辅助装置可以为单心室生理性疾病患者提供一个替代的右心室，且包括有替代流道和驱动力，用以将体静脉血液加压泵入肺动脉。同时，由于所述第一垂线与所述第二垂线相交，因此患者血液在所述流出部内流动时，血液的流动方向始终是处于相同平面的，且流动路径简短，使得所述驱动装置的效率高、能耗小，也即降低了所述心脏辅助装置的能耗。
进一步地，所述心脏辅助装置在安装时，可以将所述流出部置于患者心脏腔内，所述第一流入部和所述第二流入部置于心脏外部，所述汇流部与患者心房侧壁缝合以固定所述心脏辅助装置。此时，所述心脏辅助装置的安装只需要在患者心房侧壁上切开一个小口、而后又缝合上，几乎不会破坏患者的心脏组织，避免影响到原有心脏的其他功能的正常工作。并且，由于所述连通管道仅设置所述流出部作为其单一的流出路径，因此可以实现肺血流同源化。
附图说明
为了更清楚地说明本发明的技术方案，下面将对实施方式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发明的一些实施方式，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，还可以如这些附图获得其他的附图。
图1是本发明实施例提供的一种心脏辅助装置的结构示意图。
图2是本发明实施例提供的一种心脏辅助装置的连通管道的结构示意图。
图3是本发明实施例提供的一种心脏辅助装置的连通管道的俯视图。
图4是图1中A处结构的放大示意图。
图5是图1中B处结构的放大示意图。
图6是本发明实施例提供的一种心脏辅助装置的连通管道内部件的结构示意图。
图7是本发明实施例提供的一种心脏辅助装置的连通管道内部件的另一结构示意图。
图8是本发明实施例提供的一种心脏辅助装置的信号传送流程示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
请一并参阅图1和图2，本发明实施例提供一种心脏辅助装置，包括连通管道1、叶片2以及驱动装置3。所述连通管道1包括彼此连通的第一流入部11、第二流入部12、流出部14以及汇流部13，所述汇流部13贯通所述第一流入部11与所述第二流入部12并连通至所述流出部14。所述流出部14包括连接所述汇流部13的连接端面142，所述连接端面142的中心垂线为第一垂线1420，所述流出端面140的中心垂线为第二垂线1400，所述第一垂线1420与所述第二垂线1400相交。所述叶片2转动连接至所述流出部14的内部，用以推进所述连通管道1内的流体从所述流出部14的流出端面140流出。所述驱动装置3位于所述流出部14的外部，所述流出部14包括与所述流出端面140相对设置的底壁141，所述叶片2与所述驱动装置3分别位于所述底壁141的两侧，所述驱动装置3用以驱动所述叶片2转动。
当本实施例所述心脏辅助装置安装至患者体内时，所述连通管道1的所述第一流入部11连通患者的上腔静脉、所述第二流入部12连通患者的下腔静脉，所述流出部14连通患者的肺动脉。此时，所述驱动装置3驱动所述叶片2转动，患者的上腔静脉血和下腔静脉血由所述第一流入部11和所述第二流入部12流入所述连通管道1，在所述叶片2的推动和加压下，自所述流出部14流出所述连通管道1并流进患者肺动脉。因此，本实施例所述心脏辅助装置可以为单心室生理性疾病患者提供一个替代的右心室，且包括有替代流道和驱动力，用以将体静脉血液加压泵入肺动脉。再者，由于所述第一垂线1420与所述第二垂线1400相交，因此患者血液在所述流出部14内流动时，血液的流动方向始终是处于相同平面的，且流动路径简短，使得所述驱动装置3的效率高、能耗小，也即降低了所述心脏辅助装置的能耗。
进一步地，所述心脏辅助装置在安装时，可以将所述流出部14置于患者心脏腔内，所述第一流入部11和所述第二流入部12置于心脏外部，所述汇流 部13与患者心房侧壁缝合以固定所述心脏辅助装置。此时，所述心脏辅助装置的安装只需要在患者心房侧壁上切开一个小口、而后又缝合上，几乎不会破坏患者的心脏组织，避免影响到原有心脏的其他功能的正常工作。并且，由于所述连通管道1仅设置所述流出部14作为其单一的流出路径，因此可以实现肺血流同源化。
请一并参阅图1和图2，在本实施例中，所述叶片2与所述驱动装置3分别设置在所述底壁141的两侧，也即所述底壁141完全分隔开所述驱动装置3与所述叶片2，所述驱动装置3无线驱动所述叶片2转动。在现有技术中，关于无线驱动已经有较多实施方式，例如电磁驱动等，本实施例参考可实现的无线驱动方式进行设计即可，此处不再累述。
应当理解的是，本发明实施例所述“连接端面”可理解为所述流出部14的流入口所在的平面。在本发明描述中，将位于所述汇流部13与所述流出部14的衔接区域的多个平面中的、在所述汇流部13内流通面积最小的面定义为所述连接端面。
进一步地，请一并参阅图1和图2，所述第一流入部11的流入端面110的中心垂线为第三垂线111，所述第二流入部12的流入端面120的中心垂线为第四垂线121，所述第三垂线111和所述第四垂线121共线。
在本实施例中，由于所述第三垂线111与所述第四垂线121共线，也使得所述第一流入部11、所述第二流入部12与所述汇流部13的连接处不易产生漩涡，减少所述连通管道1内流体的能量损失。且所述连通管道1半置于患者心脏腔内，因此患者血液自上腔静脉和下腔静脉流出到流入肺动脉的流程最短、流动轨迹最接近于健康心脏，所述叶片2仅需要对血液施加很小的推动力即可以推动其流动，使得所述驱动装置3的效率高、耗能小，也降低了所述心脏辅助装置的能耗。同时，也使得贯通所述第一流入部11与所述第二流入部12的所述汇流部13的体积可以设置得较为短小，所述第一流入部11与所述第二流入部12大致处于同一个平面，使得所述心脏辅助装置的所述连通管道1整体体积小，安装方便，适用范围广。
应当理解的，所述“中心垂线”是指位于指定平面中心且垂直于指定平面的线，例如所述第一垂线1420为所述连接端面142的中心垂线，也即指位于 所述连接端面142中心且垂直于所述连接端面142的线；所述第二垂线1400为所述流出部14的流出端面140的中心垂线，也即指位于所述流出端面140中心且垂直于所述流出端面140的线；所述第三垂线111为所述第一流入部11的流入端面110的中心垂线，也即指位于所述第一流入部11的流入端面110中心且垂直于所述第一流入部11的流入端面110的线；所述第四垂线121为所述第二流入部12的流出端面140的中心垂线，也即指位于所述第二流入部12的流出端面140中心且垂直于所述第二流入部12的流出端面140的线。
进一步地，请一并参阅图1和图2，所述第一垂线1420与所述第二垂线1400形成70°至110°的角α，所述第一垂线1420与所述第三垂线111相交且形成80°至100°的角β。此时，所述连通管道1形成类似倒“h”型的流道，当所述连通管道1安装至患者体内时，所述倒“h”型的流道不会破坏患者的心脏生理性曲线，且流道形状类似于健康心脏的右心室处的血液流动轨迹，有助于降低所述驱动装置3的能耗，也即使所述心脏辅助装置更为高效、节能。当然，不同患者的心脏情况不一样，所述连通管道1的形状包括但不限于上述实施例所述情况，应当依据患者的心脏情况灵活地设计所述第三垂线111与所述第二垂线1400之间的关系。当然，在其他实施例中，所述第一流入部11与所述第二流入部12也可以相对所述流出部14产生扭转，以适应患者的心脏形状。例如，所述第一垂线1420与所述第二垂线1400形成90°的角α，所述第一垂线1420与所述第三垂线111相交且形成90°的角β，所述第一垂线1420与所述第三垂线111形成小于45°的角；或者，所述第一垂线1420与所述第三垂线111共面，且相互平行或者形成一个小于等于30°的锐角。
进一步地，请一并参阅图1和图2，在垂直于所述流出端面140的方向上，所述连接端面142的长度为第一长度L1，所述流出部14的长度为第二长度L2，所述第二长度L2大于等于二倍的所述第一长度L1，使得所述连通管道1内的流体在所述流出部14内被充分加压。
进一步地，请一并参阅图1和图2，所述叶片2在垂直于所述流出端面140的方向上的长度为第三长度L3，所述第三长度L3大于等于二倍的所述第一长度L1，且所述第三长度L3小于等于所述第二长度L2，使得所述叶片2具有 足够长的推进区域。优选的，所述第三长度L3大于等于三分之二的所述第二长度L2，也即所述流出部14的长度仅需要略大于或者等于所述叶片2的长度即可。
进一步地，请一并参阅图1和图4，所述叶片2包括靠近所述底壁141的第一端21，所述第一端21与所述底壁141之间的距离为第四长度L4，所述第四长度L4小于等于所述第一长度L1。也即所述第一端21距离所述底壁141的距离很小，从而能够降低所述驱动装置3的能耗，最佳的，所述驱动装置3与所述叶片2均紧靠所述底壁141设置。此时，所述连通管道1内的血液自所述汇流部13直接进入所述叶片2的推进区域(叶片2旋转区域均为其推进区域)，减少了所述流体的流程，降低了所述流体阻力，所述驱动装置3能耗降低，所述心脏辅助装置的效率升高。
进一步地，请一并参阅图1、图2和图5，所述心脏辅助装置还包括第一流入管011、第二流入管012和流出管014。所述第一流入管011可拆连接至所述第一流入部11，所述第二流入管012可拆连接至所述第二流入部12，所述流出管014可拆连接至所述流出部14。
在本实施例中，所述第一流入管011包括第一流通部以及用于连接所述第一流入部11的第一连接部，所述第二流入管012包括第二流通部以及用于连接所述第二流入部12的第二连接部，所述流出管014包括第三流通部以及用于连接所述流出部14的第三连接部。所述第一连接部、所述第二连接部以及所述第三连接部的材质均为硬质材料，以方便实现连接。所述第一流通部、所述第二流通部以及所述第三流通部的材质均为柔性材料，从而能够适应于不同患者的不同的血管解剖情况。
在本实施例中，所述第一连接部可拆连接至所述第一流入部11的流入端面110，所述第二连接部可拆连接至所述第二流入部12的流入端面120，所述第三连接部可拆连接至所述流出部14的流出端面140。所述可拆连接是指用于连接的连接件可拆卸，常用的例如键连接、销连接、螺纹连接和卡箍连接等。举例而言，请一并参阅图1和图5，所述第一流入部11的外壁邻近其流入端面的位置处(也即所述第一连接部)设置有凹槽113，所述第一流入管011的一端的内壁设置有凸起0113，所述凸起0113卡入所述凹槽113形成连接件， 并在所述连接件外套设紧固环114，使所述第一流入管011固定至所述连通管道1。
进一步地，请一并参阅图1、图2和图4，所述心脏辅助装置还包括缝合环4，所述缝合环4连接至所述汇流部13的外壁。所述缝合环4的内圈缝合或者卡套在所述汇流部13上，所述缝合环4的外圈用以缝合至心房侧壁，从而使所述连通管道1的所述汇流部13固定至心脏。所述缝合环4采用具有生物相容性、不可吸收的编织材料，例如可用于缝合的涤纶。举例而言，请一并参阅图1、图2和图4，所述汇流部13的外壁靠近所述连接端面142的位置处设置有一凹陷区131，所述缝合环4卡合在所述凹陷区131内以实现与所述汇流部13的固定。
进一步地，请参阅图1，为了使所述心脏辅助装置内的流体沿最佳流动轨迹流动，设置所述连通管道1的材质为硬质材料，也即所述连通管道1在所述流体的压力下不发生形变或者很微小的形变，从而使流体能够沿着预定的流道轨迹流动，以降低所述心脏辅助装置的能耗。优选的，所述连通管道1可采用轻质钛金属，其强度大，密度小，硬度大，熔点高，抗腐蚀性很强，同时具有良好的生物相容性。所述第一流入管011、所述第二流入管012以及所述流出管014的材质优选柔性材质(例如人工血管)。
进一步地，可以在所述来连通管道1的表面进行涂层，所述涂层采用抗血栓物质，以减少血栓的形成。优选的，所述涂层可采用聚四氟乙烯涂层。
进一步地，请一并参阅图1、图2以及图7，所述心脏辅助装置还包括设置在所述流出部14内的支撑架143和转轴22，所述支撑架143固定在所述流出部14的内壁，并且包括相对设置的第一支架144和第二支架145，所述叶片2围绕所述转轴22设置，所述转轴22的轴线221垂直于所述流出端面140(优选的，所述轴线与所述第二垂线1400共线)，所述转轴22转动连接在所述第一支架144与所述第二支架145之间。
在本实施例中，所述转轴22的轴线221垂直于所述流出端面140，也即所述叶片2的推进力方向垂直于所述流出端面140，所述连通管道1的流体在很小的叶片2的推进力下即能够顺利地自所述流出端面140喷射出，使得所述心脏辅助装置能耗小、更节能。当然，可以对所述叶片2的形状进行合理设计， 使其具有更大的推进力，同时减小血流对所述流出部14侧壁的冲击，以减小损耗。
本实施例中，请一并参阅图1、图6以及图7，所述第一支架144包括第一环部1441和第一辐条1442，所述第一辐条1442设置在所述第一环部1441的内圆的任一条直径的位置处，所述第一辐条1442的中部设置有第一凹槽1443；所述第二支架145包括第二环部1451和第二辐条1452，所述第二辐条1452设置在所述第二环部1451的内圆的任一条直径的位置处，所述第二辐条的中部设置有第二凹槽1453。所述转轴22的两端分别形成有第一凸起222和第二凸起223，所述第一凸起222和所述第二凸起223分别卡在所述第一凹槽1443和所述第二凹槽1453内。因此，所述转轴22卡设在所述第一支架144和所述第二支架145之间，避免了所述转轴22和所述叶片2来回摆动和上下位移。所述支撑架143还包括定位支架146，所述定位支架146连接所述第一支架144和所述第二支架145，用以固定所述第一支架144和所述第二支架145之间的间距。进一步地，所述第一凹槽1443与所述第二凹槽1453之间的最大间距(例如两个凹槽底部之间)大于所述转轴22的总长度，所述第一凹槽1443与所述第二凹槽1453之间的最小间距(例如两个凹槽的边缘之间)小于所述转轴22的总长度，从而使所述转轴22具有微小的相对移动空间，使得所述转轴22和所述叶片2在转动或者运行过程中具有一定的自调节空间，有利于所述转轴22和所述叶片2根据所述连通管道1内流体的流动情况进行调整，具有缓冲和优化能力。
在本实施例中，所述叶片2及所述转轴22均采用硬质材料，优选轻质钛金属材料。所述转轴22中空设计以减轻质量，降低所述驱动装置3的能耗。
进一步地，请一并参阅图1和图4，所述心脏辅助装置的所述驱动装置3包括电机5和控制器6，所述电机5用以驱动所述叶片2转动；所述控制器6电连接所述电机5，用以调节所述电机5的输出功率。在本实施例中，所述电机5与所述叶片2分别设置在所述底壁141的两侧，也即所述底壁141完全分隔开所述电机5与所述叶片2，所述电机5无线驱动所述叶片2转动。在现有技术中，关于无线驱动已经有较多实施方式，例如电磁驱动等，本实施例参考可实现的无线驱动方式进行设计即可，此处不再累述。应当注意的是，在本实 施例中，所述电机5与所述叶片2之间的间距应该尽可能的小，以降低所述电机5的能耗。优选的，所述电机5与所述叶片2均紧靠所述底壁141设置。
进一步地，请一并参阅图1、图2以及图4，所述心脏辅助装置还包括隔离壁51，所述隔离壁51固定至所述底壁141背离所述流出端面140的一侧，并与所述底壁141共同形成隔离腔50，所述电机5置于所述隔离腔50内。优选的，所述控制器6也置于所述隔离腔50内。所述隔离腔50为密封的腔室，当所述心脏辅助装置安装至人体时，所述隔离壁51同样内置于心脏内，所述隔离壁51将所述电机5和所述控制器6与心脏内的血液相隔离，提高了所述心脏辅助装置的生物相容性，同时保障了所述电机5与所述控制器6具有良好的使用环境、提高其使用寿命。应当注意的是，在本发明中，所述连通管道1与所述隔离壁51在设计时均采用圆弧或斜坡等过渡式的设计，避免使用直角或出现突兀的凸起部，以防止形成血栓。
进一步地，请一并参阅图1和图4，所述心脏辅助装置还包括第一电池组件71和第二电池组件72。所述第一电池组件71电连接所述电机5，用以为所述电机5提供电能。所述第二电池组件72对所述第一电池组件71进行无线充电。
在本实施例中，所述第一电池组件71包括电连接的第一蓄电池711与第一充电接口712，所述第一蓄电池711电连接所述电机5。所述第二电池组件72包括电连接的第二蓄电池721和第二充电接口722。所述第一充电接口712与所述第二充电接口722之间无线连接，使所述第二蓄电池721内的电能转移至所述第一蓄电池711。
当所述心脏辅助装置安装至人体时，所述第一电池组件71置于体内、所述第二电池组件72置于体外。所述第一电池组件71通过电线连接至电机5，所述第一电池组件71置于心脏外，埋设在皮下即可(腹部为佳)。所述第二电池组件72设置在一个腰带上，使用者佩戴腰带后，所述第二电池组件72正对所述第一电池组件71。所述第二电池组件72对所述第二电池组件72进行无线充电，所述无线充电参考可实现的无线充电方式即可。
进一步地，请一并参阅图1、图4和图8，所述的心脏辅助装置还包括传感装置100和信号处理装置101。所述传感装置100用以检测所述连通管道1 内的流体参数，并形成第一信号S1传送至所述信号处理装置101。所述信号处理装置101用以接收、存储以及处理所述第一信号S1，并形成第二信号S2传送至所述控制器6，使所述控制器6调节所述电机5的输出功率。应当理解是的，本实施例所述流体参数包括但不限于压力、粘度、流速、温度、密度等。所述传感装置100可以依据需求，同时设置有多个传感器以检测多个不同的参数，或者在所述连通管道1的多个位置同时安装多个传感器以检测多个不同位置的同一个参数。进一步地，所述传感装置100也可以同时检测所述叶片2和/或所述电机5的工作参数，例如转速、功率等，同时传送相关数据至所述信号处理装置101，以获得更为理想的第二信号S2，从而提高所述电机5的工作效率、降低所述心脏辅助装置的能耗。当然，所述传感装置100也可以依据具体需求检测其他参数。
进一步地，请一并参阅图1、图4和图8，所述心脏辅助装置的所述信号处理装置101包括芯片81和处理器82。所述芯片81传送原始数据S3至所述处理器82。所述处理器82接收所述原始数据S3、形成反馈数据S4，并传送所述反馈数据S4至所述芯片81。所述处理器82包括显示屏821，所述显示屏821用以显示所述原始数据S3和/或所述反馈数据S4。
在本实施例中，所述芯片81和所述处理器82均具有信号处理能力，而所述处理器82更具有修改所述芯片81内部数据/程序的能力，以使所述信号处理装置101依据使用者的身体状态变化(静息或运动状态、血管阻力变化等)进行合理调整，使所述心脏辅助装置符合患者实时的生理状态，同时还可延长电池续航时间、延长所述心脏辅助装置的使用寿命等。同时，本实施例中所述显示屏821更是能够直观地表达出使用者的身体情况和所述心脏辅助装置的工作状态，有助于诊断和治疗使用者。
当所述心脏辅助装置安装至人体时，所述控制器6和所述芯片81置于体内。所述芯片81通过数据线连接至所述控制器6，所述第一芯片81置于心脏外，埋设在皮下即可(腹部为佳)。所述处理器82可以集成设置在设置有第二电池组件72的腰带上，使用者佩戴腰带后，所述处理器82正对所述芯片81。所述处理器82与所述芯片81双向无线传送数据。
同时，所述显示屏821可以设置在所述腰带的外表面，使用者可以直接观 看所述显示屏821的显示图像。
以上对本发明实施例进行了详细介绍，本文中应用了具体个例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想；同时，对于本领域的一般技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本发明的限制。

Claims (17)

  1. 一种心脏辅助装置，其特征在于，包括：
    连通管道，包括彼此连通的第一流入部、第二流入部、流出部以及汇流部，所述汇流部贯通所述第一流入部与所述第二流入部并连通至所述流出部，所述流出部包括连接所述汇流部的连接端面，所述连接端面的中心垂线为第一垂线，所述流出端面的中心垂线为第二垂线，所述第一垂线与所述第二垂线相交；
    叶片，转动连接至所述流出部的内部，用以推进所述连通管道内的流体从所述流出部的流出端面流出；及
    驱动装置，所述驱动装置位于所述流出部的外部，所述流出部包括与所述流出端面相对设置的底壁，所述叶片与所述驱动装置分别位于所述底壁的两侧，所述驱动装置用以驱动所述叶片转动。
  2. 如权利要求1所述的心脏辅助装置，其特征在于，所述第一流入部的流入端面的中心垂线为第三垂线，所述第二流入部的流入端面的中心垂线为第四垂线，所述第三垂线和所述第四垂线共线。
  3. 如权利要求2所述的心脏辅助装置，其特征在于，所述第一垂线与所述第二垂线形成70°至110°的角，所述第一垂线与所述第三垂线相交且形成80°至100°的角。
  4. 如权利要求1所述的心脏辅助装置，其特征在于，在垂直于所述流出端面的方向上，所述连接端面长度为第一长度，所述流出部的长度为第二长度，所述第二长度大于等于二倍的所述第一长度。
  5. 如权利要求4所述的心脏辅助装置，其特征在于，在垂直于所述流出端面的方向上，所述叶片的长度为第三长度，所述第三长度大于等于二倍的所述第一长度且小于所述第二长度。
  6. 如权利要求5所述的心脏辅助装置，其特征在于，所述叶片包括靠近所述底壁的第一端，所述第一端与所述底壁之间的距离为第四长度，所述第四长度小于所述第一长度。
  7. 如权利要求1所述的心脏辅助装置，其特征在于，所述心脏辅助装置还包括：
    第一流入管，所述第一流入管可拆连接至所述第一流入部；
    第二流入管，所述第二流入管可拆连接至所述第二流入部；及
    流出管，所述流出管可拆连接至所述流出部。
  8. 如权利要求7所述的心脏辅助装置，其特征在于，所述第一流入管包括第一流通部以及用于连接所述第一流入部的第一连接部，所述第二流入管包括第二流通部以及用于连接所述第二流入部的第二连接部，所述流出管包括第三流通部以及用于连接所述流出部的第三连接部，所述第一连接部、所述第二连接部以及所述第三连接部的材质均为硬质材料，所述第一流通部、所述第二流通部以及所述第三流通部的材质均为柔性材料。
  9. 如权利要求1所述的心脏辅助装置，其特征在于，所述连通管道的材质为钛金属。
  10. 如权利要求1所述的心脏辅助装置，其特征在于，所述心脏辅助装置还包括设置在所述流出部内的支撑架和转轴，所述支撑架固定在所述流出部的内壁，并且包括相对设置的第一支架和第二支架，所述叶片围绕所述转轴设置，所述转轴的轴线垂直于所述流出端面，所述转轴转动连接在所述第一支架与所述第二支架之间。
  11. 如权利要求1所述的心脏辅助装置，其特征在于，所述心脏辅助装置还包括缝合环，所述缝合环连接至所述汇流部的外壁。
  12. 如权利要求11所述的心脏辅助装置，其特征在于，所述缝合环位于所述汇流部的靠近所述流出部的一端。
  13. 如权利要求1所述的心脏辅助装置，其特征在于，所述驱动装置包括电机和控制器，所述电机用以驱动所述叶片转动，所述控制器电连接所述电机，用以调节所述电机的输出功率；
    所述心脏辅助装置还包括隔离壁，所述隔离壁固定至所述底壁背离所述流出端面的一侧，并与所述底壁共同形成隔离腔，所述电机位于所述隔离腔的内部。
  14. 如权利要求13所述的心脏辅助装置，其特征在于，所述心脏辅助装置还包括第一电池组件和第二电池组件；
    所述第一电池组件电连接所述电机，用以为所述电机提供电能；
    所述第二电池组件对所述第一电池组件进行无线充电。
  15. 如权利要求14所述的心脏辅助装置，其特征在于，所述第一电池组件包括电连接的第一蓄电池和第一充电接口，所述第一蓄电池电连接所述电机；
    所述第二电池组件包括电连接的第二蓄电池和第二充电接口，所述第二充电接口与所述第一充电接口之间无线连接，使所述第二蓄电池内的电能转移至所述第一蓄电池。
  16. 如权利要求13所述的心脏辅助装置，其特征在于，所述心脏辅助装置还包括传感装置和信号处理装置；
    所述传感装置用以检测所述连通管道内的流体参数，并形成第一信号传送至所述信号处理装置；
    所述信号处理装置用以接收、存储以及处理所述第一信号，并形成第二信号传送至所述控制器，使所述控制器调节所述电机的输出功率。
  17. 如权利要求16所述的心脏辅助装置，其特征在于，所述信号处理装置包括芯片和处理器；
    所述芯片传送原始数据至所述处理器；
    所述处理器接收所述原始数据、形成反馈数据，并传送所述反馈信号至所述芯片；
    所述处理器包括显示屏，所述显示屏用以显示所述原始数据和/或所述反馈数据。
PCT/CN2017/071197 2016-02-02 2017-01-14 心脏辅助装置 WO2017133427A1 (zh)

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