WO2017133425A1 - Dispositif d'assistance ventriculaire droite - Google Patents

Dispositif d'assistance ventriculaire droite Download PDF

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Publication number
WO2017133425A1
WO2017133425A1 PCT/CN2017/071195 CN2017071195W WO2017133425A1 WO 2017133425 A1 WO2017133425 A1 WO 2017133425A1 CN 2017071195 W CN2017071195 W CN 2017071195W WO 2017133425 A1 WO2017133425 A1 WO 2017133425A1
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WO
WIPO (PCT)
Prior art keywords
length
end surface
assist device
outflow
heart assist
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Application number
PCT/CN2017/071195
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English (en)
Chinese (zh)
Inventor
丁以群
Original Assignee
丁以群
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Publication date
Application filed by 丁以群 filed Critical 丁以群
Publication of WO2017133425A1 publication Critical patent/WO2017133425A1/fr

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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
    • A61M60/10—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
    • A61M60/876—Implantable batteries
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J7/00—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a right heart assist device.
  • a right ventricular assist device For patients with right heart failure, in the case of ineffective drug treatment, it is usually necessary to set up a right ventricular assist device, the purpose of which includes: (1) waiting for the donor to prepare for heart transplantation; Restore heart function.
  • right heart assist devices mainly including pneumatic pumps and centrifugal pumps.
  • the main features are open chest insertion, perforation in the avascular free area of the right ventricle, and drainage of right ventricular blood into the right heart assist device.
  • the blood is pumped into the pulmonary artery via the artificial blood vessel.
  • the advantages of the pneumatic pump are that the consumables are easy to replace, the driving device is simple in design, and the pulsating blood flow is formed; the disadvantage is that the driving device is large and is not suitable for being placed in the body, and the pump body and the visible pumping activity exposed to the outside of the body are not suitable. , adversely affect the patient's psychology; need to connect the heart chamber and the aorta with a tube, increase energy consumption, and easily form a thrombus.
  • the advantage of the centrifugal pump is that it has small blood damage and is suitable for installation in the thoracic cavity.
  • the disadvantage is that the right wall of the right chamber is perforated, destroying the integrity of the ventricle, and negatively affecting the recovery of ventricular function; the pump is connected to the pump body and the pulmonary artery, and the power consumption is large. The fever is large and it is easy to cause thrombosis.
  • the pump body has been greatly reduced, it is still located between the outer membrane of the heart and the pericardium, forming a steric hindrance, and aggravating foreign matter friction due to the non-physiological curve structure.
  • the technical problem to be solved by the present invention is to provide a right heart assist device that can be built into the heart cavity without damaging the heart structure.
  • Providing a right heart assist device comprising:
  • the first duct includes an inflow portion and an outflow portion that communicate with each other, a central perpendicular of the inflow end surface of the inflow portion is a first vertical line, and a center perpendicular of the outflow end surface of the outflow portion is a second perpendicular line. a first perpendicular intersects the second perpendicular and forms an angle of 45° to 100°;
  • 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.
  • the outflow portion includes a connecting end surface connecting the inflow portion, wherein a length of the connecting end surface is a first length and a length of the outflow portion is a second length in a vertical direction of the outflow end surface, The second length is greater than or equal to twice the first length.
  • the length of the blade in the vertical direction of the outflow end surface 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 less than or equal to the first length.
  • the length of the inflow portion is a fifth length, and the fifth length is greater than the first length.
  • the outer diameter of the inflow end surface is a first diameter
  • the outer diameter of the outflow end surface is a second diameter
  • the first diameter is greater than or equal to the second diameter
  • the right heart auxiliary device further includes a second pipe, and the second pipe is detachably connected to the outflow portion.
  • the second pipe includes a connecting portion, and the connecting portion is detachably connected to the outflow portion, and the connecting portion is made of a hard material.
  • the inflow portion is provided with a bypass flow inlet, and the bypass flow inlet is spaced apart from the inflow end surface of the inflow portion.
  • the sewing ring is provided at one end of the inflow portion toward the inflow end surface.
  • the material of the first pipe is titanium metal.
  • the right-heart auxiliary 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 bracket disposed opposite to each other, The blade is disposed around the rotating shaft, the 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 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 right-hand auxiliary 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, wherein the motor is located in the isolation cavity internal.
  • the right heart 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 right heart assist device further comprises a sensing device and a signal processing device
  • the sensing device is configured to detect a fluid parameter in the first 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 first conduit of the right-heart assist device of the present invention forms a flow channel similar to a " ⁇ " type, and since the " ⁇ "-type flow passage conforms to the physiological anatomy of the right ventricle, the right ventricular physiological curve is not destroyed,
  • the first conduit can be built into the right ventricle of the patient, and the inflow end surface connects the intramedullary tricuspid annulus to achieve fixation of the first conduit.
  • the outflow end face of the first conduit communicates with the pulmonary artery of the patient.
  • the driving device drives the blade to rotate, and blood in the right atrium of the patient flows into the first duct from the inflow end surface, and flows out from the outflow end surface under the pushing and pressing of the blade
  • the first tube flows into the patient's pulmonary artery. Therefore, the right heart assist device of the present embodiment can provide an alternative right ventricle for patients with right heart failure, and includes a blood pressure pump for replacing the flow channel and driving force for returning the body vein into the right atrium. Into the pulmonary artery.
  • the right heart assisting device of the embodiment can realize the built-in heart cavity, and the shape of the flow channel conforms to the physiological anatomy of the right ventricle, and does not damage the heart structure.
  • FIG. 1 is a schematic structural diagram of a right-heart assist device according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural view of a first duct of a right-heart assist device according to an embodiment of the present invention.
  • FIG 3 is a top plan view of a first duct of a right-heart 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 diagram of a first inner pipe component of a right-heart assist device according to an embodiment of the present invention.
  • FIG. 7 is another schematic structural diagram of a first inner pipe component of a right-heart assist device according to an embodiment of the present invention.
  • FIG. 8 is a schematic structural diagram of another first conduit of a right-center assisting device according to an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of a signal transmission process of a right-heart assist device according to an embodiment of the present invention.
  • an embodiment of the present invention provides a right heart assist device that can be applied to a patient with right heart failure.
  • the right-heart assist device comprises a first duct 1, a blade 2 and a drive device 3.
  • the first duct 1 includes an inflow portion 11 and an outflow portion 12 that communicate with each other, and a center perpendicular of the inflow end surface 110 of the inflow portion 11 is a first vertical line 111, and a center of the outflow end surface 120 of the outflow portion 12 is suspended.
  • the line is a second perpendicular line 121 that intersects the second perpendicular line 121 and forms an angle ⁇ and satisfies 45° ⁇ ⁇ ⁇ 100°.
  • the vane 2 is rotatably coupled to the interior of the outflow portion 12 for propelling fluid within the first conduit 1 from the outflow end surface 120.
  • the driving device 3 is located outside the outflow portion, and the outflow portion 12 includes a bottom wall 122 disposed opposite to the outflow end surface 120, and the blade 2 and the driving device 3 are respectively located at the bottom wall 122. On both sides, the driving device 3 is used to drive the blade 2 to rotate.
  • the center perpendicular of the two end faces of the first duct 1 of the right-heart assist device (ie, the first perpendicular line 111 and the second perpendicular line 121) form 45°.
  • the angle to 100°, that is, the first duct 1 forms a flow path similar to the " ⁇ " type. Since the " ⁇ " type flow path conforms to the physiological anatomy of the right ventricle and does not damage the right ventricular physiological curve, the first conduit 1 can be built into the patient when the right heart assist device is installed in the patient. In the right ventricle, and the inflow end face 110 is connected to the intramedullary tricuspid annulus to effect fixation of the first conduit 1.
  • the right heart assist device of the present embodiment can provide an alternative right ventricle for patients with right heart failure, and includes a blood pressure pump for replacing the flow channel and driving force for returning the body vein into the right atrium.
  • the right heart assisting device of the embodiment can realize the built-in heart cavity, and the shape of the flow channel conforms to the right ventricle anatomy without damaging the heart structure.
  • the shape of the " ⁇ "-type flow channel of the right-heart assist device in this embodiment is similar to the blood flow trajectory at the right ventricle of the healthy heart.
  • the flow trajectory in the right-heart assist device can be reached. Consistent with the blood flow trajectory at the right ventricle of a healthy heart.
  • the flow of the patient's blood from the right atrium to the inflowing pulmonary artery is the shortest, and the flow trajectory is closest to the healthy heart, so the blade 2 only needs to exert a small pushing force on the blood to push the flow thereof, the driving device 3
  • the efficiency is high and the energy consumption is small, thereby also reducing the energy consumption of the right-heart assist device.
  • the first vertical line 111 and the second vertical line 121 intersect and form an angle ⁇ , so the inflow portion 11 and the outflow portion of the first duct 1 12 is roughly in the same plane, small in size, easy to put into the right ventricle.
  • the blood is usually rushed to the horizontal edge flow channel by the vertical central flow channel, and the flow is long, the blood is continuously reversed during the flow, and the direction is not coplanar. Therefore, the energy loss is extremely large, and the centrifugal pump consumes a large amount of power.
  • the “center vertical line” refers to a line located at the center of the designated plane and perpendicular to the designated plane.
  • the first vertical line 111 refers to a line located at the center of the inflow end surface 110 and perpendicular to the inflow end surface 110.
  • the second vertical line 121 refers to a line located at the center of the outflow end surface 120 and perpendicular to the outflow end surface 120.
  • the resistance of the fluid in the first conduit 1 is the smallest.
  • the inflow portion 11 of the first duct 1 includes a small section of a circular tube adjacent to the inflow end surface 110 and a flat tube portion connected to the outflow portion 12,
  • the outflow portion 12 has a circular tube shape, that is, the shape of the pipe of the first pipe 1 changes from the inflow end surface 110 to the outflow end surface 120 as follows: a circular tube - a flat tube - a round tube, and the flat tube
  • the flow area is not required to be constant.
  • the shape change of the pipe is a gentle transition.
  • the round tube portion of the inflow portion 11 is for facilitating connection of the inflow end surface 110 to the tricuspid annulus; the flat tube portion of the inflow portion 11 is for reducing the first duct 1 perpendicular to the outflow end surface
  • the size in the direction of 120 that is, the reduction
  • the volume of the first duct 1 is provided to provide a space for other components (for example, the driving device 3) so that the components of the right heart assisting device are placed in a reasonable and compact position, and the volume of the right-center assisting device is reduced.
  • the shape of the pipe of the first pipe 1 can be designed and changed according to the requirements of the specific application environment, and is not limited to the shape described in the above embodiments.
  • the blade 2 and the driving device 3 are respectively disposed on two sides of the bottom wall 122, that is, the bottom wall 122 is completely separated.
  • the drive device 3 and the blade 2 are opened, and the drive 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.
  • the outflow portion 12 of the first duct 1 includes a connecting end surface 123, and the connecting end surface 123 connects the inflow portion 11.
  • the length of the connecting end surface 123 is a first length L1
  • the length of the outflow portion 12 is a second length L2
  • the second length L2 is greater than or equal to two times
  • the first length L1 causes the fluid in the first conduit 1 to be sufficiently pressurized within the outflow portion 12.
  • connection end face 123 in the embodiment of the present invention can be understood as the plane in which the flow inlet of the outflow portion 12 is located.
  • the surface having the smallest flow area among the plurality of planes of the joining portion of the inflow portion 11 and the outflow portion 12 is defined as the connecting end surface 123.
  • the length of the blade 2 in the vertical direction of the outflow end surface 120 is a third length L3, and the third length L3 is greater than or equal to twice the first
  • the length L1 is smaller than the second length L2 such that the blade 2 has a sufficiently long advancement area.
  • 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 12 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 122 , and a distance between the first end 21 and the bottom wall 122 is 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 122 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 122 is disposed.
  • the blood in the first duct 1 directly enters the propulsion region of the vane 2 from the inflow portion 11 (the rotation region of the vane 2 is its propulsion region), which reduces the flow of the fluid and reduces the Fluid resistance, the driving device 3
  • the energy consumption is reduced and the efficiency of the right heart assist device is increased.
  • the length of the inflow portion 11 is a fifth length L5, and the fifth length L5 is greater than the first length L1. That is, in the direction perpendicular to the outflow end surface 120, the size of the first duct 1 has a long-short-long change, and the junction area of the inflow portion 11 and the outflow portion 12 forms a joint.
  • the recessed area of the first duct 1 is used to accommodate the supracondylar structure of the chamber, so that the first duct 1 is more in line with the physiological anatomy of the right heart of the patient.
  • the respective portions of the first duct 1 have the same size, that is, the structure as shown in FIG. At this time, in the process in which blood flows from the inflow end surface 110 to the connection end surface 123, the flow area is reduced and the flow velocity is increased.
  • the outer diameter of the inflow end surface 110 is a first outer diameter D1
  • the outer diameter of the outflow end surface 120 is a second diameter D2
  • the second diameter D2 is greater than or equal to enable the first duct 1 to be smoothly installed into the right ventricle of the patient.
  • the right-hand auxiliary device further includes a second duct 4, and the second duct 4 is detachably connected to the outflow portion. 12, that is, one end of the second duct 4 is connected to the outflow end surface 120.
  • the second duct 4 since the second duct 4 is provided, the other end of the second duct 4 can be passed through the pulmonary valve annulus of the patient into the pulmonary artery to allow blood to enter the patient from the first duct 1 Pulmonary artery.
  • the length of the outflow portion 12 may be short, and the distance from the outflow end surface 120 to the pulmonary valve annulus is filled by the second duct 4, so that the right heart assisting device can be applied to various types. Different application environments improve versatility.
  • one end of the second duct 4 is detachably connected to the outflow end surface 120 of the first duct 1, and the detachable connection refers to a detachable connecting member for connection, such as a key connection. , pin connections, threaded connections and clamp connections.
  • the second duct 4 includes a connecting portion and a circulation portion, and the connecting portion is detachably connected to the outflow portion 12, and the connecting portion is made of a hard material to facilitate connection.
  • a groove 1201 is disposed at a position of the outer wall of the outflow portion 12 adjacent to the outflow end surface 120 (that is, the connecting portion), and an inner wall of one end of the second pipe 4 is provided with a protrusion. 41.
  • the protrusion 41 is snapped into the groove 1201 to form a connecting member, and a fastening ring 42 is jacketed on the connecting member to fix the second pipe 4 to the first pipe 1.
  • the flow area of the circulation portion is not fixed and can be flexibly designed according to the physical condition of the patient.
  • the flow area of the circulation portion may be smaller than the flow area of the connection portion (that is, smaller than the flow area of the outflow portion 12), and the flow portion may be provided with a convergent structure at a position where the connection portion is connected.
  • the inflow portion 11 is provided with a bypass flow inlet 112 , and the bypass flow inlet 112 is spaced apart from the inflow end surface 110 of the inflow portion 11 , that is, the The bypass inflow port 112 and the inflow end surface 110 are independent of each other such that the bypass inflow port 112 becomes an inlet of the other inflow portion 11.
  • the bypass flow inlet 112 may be provided in plurality and its position may be adjusted depending on the heart condition of the patient. For example, the bypass flow inlet 112 may be opened on a side of the inflow portion 11 away from the outflow portion 12.
  • an end of the inflow portion 11 facing the inflow end surface 110 (for example, a portion of the round tube of the inflow portion 11) is provided with a sewing ring 113, the sewing ring
  • the inner ring of 113 is stitched or ferred on the inflow portion 11, and the outer ring of the sewing ring 113 is used for sewing to the tricuspid annulus of the heart, thereby fixing the inflow end surface 110 of the first duct 1 To the heart.
  • the sewing ring 113 employs a biocompatible, non-absorbable woven material, such as polyester that can be used for stitching.
  • a recessed area 1130 is disposed at an outer wall of the inflow portion 11 near the inflow end surface 110 , and the sewing ring 113 is engaged in the recessed area 1130 . The fixing to the inflow portion 11 is achieved.
  • the material of the first pipe 1 is set to be a hard material, that is, the first pipe 1 is No deformation or very slight deformation occurs under the pressure of the fluid, thereby enabling fluid to flow along a predetermined flow path trajectory to reduce energy consumption of the right heart assist device.
  • the first pipe 1 can be made of lightweight titanium, which has high strength, small density, high hardness, high melting point and strong corrosion resistance.
  • the material of the second pipe 4 may be a flexible material (for example, an artificial blood vessel) or a rigid material (for example, titanium metal).
  • a coating may be applied on the surface of the first conduit 1, which uses an antithrombotic substance to reduce the formation of blood clots.
  • the coating may be coated with a polytetrafluoroethylene.
  • the right-heart assist device further includes a support frame 200 and a rotating shaft 20 disposed in the outflow portion 12 , and the support frame 200 is fixed at the outflow.
  • the axis 203 of the rotating shaft 20 is perpendicular to the outflow end surface 120, that is, the direction of the propulsive force of the vane 2 is perpendicular to the outflow end surface 120, and the fluid in the first duct 1 is very
  • the small blade 2 can be smoothly ejected from the outflow end surface 120 under the propulsive force, so that the right-heart auxiliary device consumes less energy and is more energy-saving.
  • the shape of the blade 2 can be rationally designed to have greater propulsive force while reducing the impact of blood flow on the side wall of the outflow portion 12 to reduce losses.
  • the first bracket 201 includes a first ring portion 2011 and a first spoke 2012, and the first spoke 2012 is disposed at the first ring portion.
  • a first groove 2013 is provided in a middle portion of the first spoke 2012;
  • the second bracket 202 includes a second ring portion 2021 and a second spoke 2022, the second The spokes 2022 are disposed at any one of the diameters of the inner circumference of the second ring portion 2021, and the second portion of the second spokes 2022 is provided with a second groove 2023.
  • the support frame 200 further includes a positioning bracket 204, and the positioning bracket 204 connects the first bracket 201 and the second bracket 202 for fixing between the first bracket 201 and the second bracket 202. spacing.
  • a maximum distance between the first groove 2013 and the second groove 2023 is greater than a total length of the rotating shaft 20, the first groove 2013 and The minimum spacing between the second grooves 2023 (for example, between the edges of the two grooves) is smaller than the total length of the rotating shaft 20, so that the rotating shaft 2032 has a slight relative movement space, so that the rotating shaft 20 And the blade 2 has a certain self-adjusting space during rotation or operation, which facilitates the flow of the rotating shaft 20 and the blade 2 according to the fluid in the first pipe 1 Condition adjustments with buffering and optimization capabilities.
  • the blade 2 and the rotating shaft 20 are both made of a hard material, preferably a lightweight titanium material.
  • the rotating shaft 20 is hollow in design to reduce the quality and reduce the energy consumption of the driving device 3.
  • the driving device 3 of the right-heart assist device includes a motor 5 and a controller 6 for driving the blade 2 to rotate; the controller 6 electrically connecting the motor 5 for adjusting the output power of the motor 5.
  • the motor 5 and the blade 2 are respectively disposed on two sides of the bottom wall 122, that is, the bottom wall 122 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 both disposed adjacent to the bottom wall 122.
  • the right-hand auxiliary device further includes a partition wall 51 fixed to a side of the bottom wall 122 facing away from the outflow end surface 120, and The bottom wall 122 collectively forms an isolation chamber 50 in which the motor 5 is placed.
  • the controller 6 is also placed within the isolation chamber 50.
  • the isolation chamber 50 is a sealed chamber.
  • the first pipe 1 and the partition wall 51 are designed to adopt a transitional design such as a circular arc or a slope, so as to avoid the use of a right angle or a protruding protrusion to prevent Form a thrombus.
  • the right-heart 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 Wirelessly connecting with the second charging interface 722 to transfer electrical energy in the second battery 721 to the first battery 711.
  • the first battery assembly 71 When the right heart 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 right-heart assist device further includes a sensing device 100 and a signal processing device 101.
  • the sensing device 100 is configured to detect a fluid parameter in the first conduit 1 (and the second conduit 4) and form a first signal S1 to be 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 simultaneously in multiple positions of the first pipe 1 (with the second pipe 4) To detect the same parameter at multiple different locations. 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 right-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 right-heart 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 processor 82 According to the user's physical state changes (rest or exercise state, vascular resistance changes, etc.) Reasonable adjustment is made to make the right heart auxiliary device conform to the real-time physiological state of the patient, and at the same time, the battery life time can be extended, and the service life of the right heart auxiliary device can be prolonged.
  • the display screen 821 in the embodiment can intuitively express the physical condition of the user and the working state of the right-heart assist 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 may be disposed on an outer surface of the waist belt, and the user may directly view the display image of the display screen 821.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Mechanical Engineering (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Power Engineering (AREA)
  • External Artificial Organs (AREA)

Abstract

Dispositif d'assistance ventriculaire droite comprenant un premier passage (1), lequel comprend une partie d'entrée (11) de liquide et une partie de sortie (12) de liquide, la ligne verticale centrale de la surface d'extrémité (110) de l'entrée de liquide de la partie d'entrée (11) de liquide constitue une première ligne verticale (111) et la ligne verticale centrale de la surface d'extrémité (120) de sortie de liquide de la partie de sortie (12) de liquide constitue une seconde ligne verticale (121), la première ligne verticale (111) et la seconde ligne verticale (121) formant un angle entre 45 et 100° au point où elles se croisent ; des ailettes (2), reliées par rotation à une partie interne de la partie de sortie (12) de liquide, servant à assurer l'écoulement d'un liquide contenu dans le premier passage (1) depuis la surface d'extrémité (120) de sortie de liquide ; et un dispositif d'entrainement (3) se trouvant sur la partie externe de la partie de sortie (12) de liquide. La partie de sortie (12) de liquide comprend une paroi inférieure (122) disposée en correspondance avec la surface d'extrémité (120) de sortie de liquide, les ailettes (2) étant disposées avec le dispositif d'entrainement (3) de part et d'autre de la paroi inférieure (122) et le dispositif d'entrainement (3) faisant tourner par entrainement les ailettes (2). Ce dispositif d'assistance ventriculaire droite peut être logé dans la cavité cardiaque sans endommager ni affecter la structure cardiaque.
PCT/CN2017/071195 2016-02-02 2017-01-14 Dispositif d'assistance ventriculaire droite WO2017133425A1 (fr)

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US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
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US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof

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