WO2024037105A1 - Pompe à sang interventionnelle avec fonction de réglage de la flexion - Google Patents

Pompe à sang interventionnelle avec fonction de réglage de la flexion Download PDF

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Publication number
WO2024037105A1
WO2024037105A1 PCT/CN2023/097223 CN2023097223W WO2024037105A1 WO 2024037105 A1 WO2024037105 A1 WO 2024037105A1 CN 2023097223 W CN2023097223 W CN 2023097223W WO 2024037105 A1 WO2024037105 A1 WO 2024037105A1
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WO
WIPO (PCT)
Prior art keywords
bending
interventional
wire
blood pump
proximal end
Prior art date
Application number
PCT/CN2023/097223
Other languages
English (en)
Chinese (zh)
Inventor
韩志富
王超
张栩曼
张宏庆
王献
Original Assignee
航天泰心科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 航天泰心科技有限公司 filed Critical 航天泰心科技有限公司
Publication of WO2024037105A1 publication Critical patent/WO2024037105A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—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
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—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
    • 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
    • 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
    • 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
    • A61M60/857—Implantable blood tubes
    • 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
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • 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
    • A61M60/90—Details not provided for in groups A61M60/40, A61M60/50 or A61M60/80
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted

Definitions

  • the present application relates to the field of medical devices, and in particular to an interventional blood pump with a bending function that is percutaneously inserted into a patient's blood vessel.
  • Interventional catheter pumps also known as interventional blood pumps, are mostly used in high-risk percutaneous coronary intervention (PCI) to reduce ventricular work and provide necessary circulatory support for cardiac recovery and early assessment of residual myocardial function.
  • PCI percutaneous coronary intervention
  • the most mature and advanced interventional catheter pump in the world is the Impella series developed by AbioMed.
  • This type of blood pumping auxiliary device is introduced into the patient's heart through blood vessels. When working, the catheter pump inlet is placed in the ventricle and the outlet is placed in the artery. It pumps blood from the ventricle into the artery to ensure the patient's coronary artery and various organs throughout the body during PCI surgery. Blood perfusion reduces heart load.
  • This type of catheter pump generally consists of a catheter, an impeller, a motor and other components. When the motor drives the impeller to rotate, blood is transported from the inlet to the outlet of the blood pump catheter.
  • the existing interventional blood pump is generally guided by a guide wire through the blood vessel and placed between the ventricle and the artery.
  • a guide wire through the blood vessel and placed between the ventricle and the artery.
  • doctors it was extremely difficult for doctors to adjust the position of the blood pump.
  • the blood pump should be centered with the valve annulus, but a blood vessel that is too curved will cause the blood pump to lean to one side of the blood vessel wall, which is not conducive to the work of the blood pump.
  • the inlet of the blood pump is prone to suction and damages the ventricular wall, and the outlet of the blood pump It is easy to cause greater impact on the blood vessel wall.
  • One purpose of this application is to solve the above technical problems.
  • the present application provides an interventional blood pump, including a pump head, a handle, and a connector connecting the pump head and the handle.
  • the pump head When the pump head is in a working position in the heart, the handle is located outside the body, and the connector is at least partially located inside the body.
  • the interventional blood pump further includes a bending mechanism, and the bending mechanism is configured to adjust the bending degree and bending direction of the connecting piece.
  • the blood pump according to the present application has a bending function, can better adapt to the curved blood vessel structure during the intervention process, has good passability, can reduce the friction between the distal end of the catheter and the blood vessel wall, and reduces
  • the vascular injury can be more easily placed to the ideal desired position, and after being placed in place, the posture can be continued to be adjusted through the bending mechanism until the position of the pump head is adjusted to the optimal position.
  • the bending mechanism in the above-mentioned interventional blood pump, includes one or more bending wires passed through the connector and a bending control component located outside the body during operation.
  • the distal end is connected to the bending point at the proximal end of the pump head, and the proximal end of the bending wire is connected to the bending control component.
  • the bending control component is used to adjust the tightness of the bending wire to control the bending degree of the connecting piece. When the bending wire is tightened, a bending force will be exerted on the connecting piece, causing the more flexible section to bend toward the side where the bending point is located.
  • the bending point is radially away from the central axis of the proximal end of the pump head. In this way, the tensile force exerted by the bending wire at the bending point can generate a greater moment relative to the central axis, making it easier to bend the connector.
  • the bending control assembly includes a bending member connected to the bending wire and a driving member capable of driving the bending member to perform reciprocating linear motion or rotational motion.
  • the bending control assembly further includes a chute, and the bending member is an externally threaded member that can be axially slidably disposed in the chute.
  • the sliding block is a threaded slide block
  • the driving part is a rotating sleeve with internal threads and set outside the slide block. When the rotating sleeve rotates, it can drive the slide block to perform reciprocating linear motion in the slide groove.
  • Such a bending control component has a simple and reliable structure, and is easy to process and operate.
  • the angle between the axis of the bending control component and the axis of the handle is greater than or equal to 0 degrees and less than 90 degrees, more preferably, greater than 30 degrees and less than 60 degrees.
  • the included angle is 0 degrees, it means that the bending control component is coaxially arranged with the handle.
  • the bending wire can be connected to the bending control component without bending on the handle 8, reducing the risk of breakage.
  • the angle is greater than 0 degrees, it means that the bending control component is set on one side of the handle. In this case, it is convenient to avoid other components in the handle, making it easier to arrange various conduits, cables, wires, etc.
  • the bending wire in the above-mentioned interventional blood pump, includes a first bending wire and a second bending wire, and the distal end of the first bending wire is connected to the first bending wire at the proximal end of the pump head.
  • the bending point, the distal end of the second bending wire is connected to the second bending point at the proximal end of the pump head,
  • the bending member includes a first rack connected to the proximal end of the first bending wire and a second rack connected to the proximal end of the first bending wire.
  • the proximal end of the bent wire is connected to a second rack.
  • the driving member includes a gear located between the first rack and the second rack and meshing with them and a knob fixed to the gear.
  • the knob rotates, it can drive the first rack.
  • the rack and the second rack move linearly in opposite directions. Since two bending wires are provided, the connecting piece can be bent in two directions, and the bending control assembly composed of a rack and gear is simple and reliable.
  • you want the connecting piece to bend toward the side where the first bending point is located turn the knob to move the first rack away from the handle, thereby tightening the first bending wire, and at the same time, move the second rack closer to The directional movement of the handle causes the second bending wire to relax and vice versa.
  • the bending wire in the above-mentioned interventional blood pump, includes a first bending wire and a second bending wire, and the distal end of the first bending wire is connected to the first bending wire at the proximal end of the pump head.
  • the bending point, the distal end of the second bending wire is connected to the second bending point at the proximal end of the pump head,
  • the bending member includes a first bevel gear connected with the proximal end of the first bending wire and a second bending gear connected with the proximal end of the first bending wire.
  • the proximal end of the bent wire is connected to a second bevel gear.
  • the driving member includes a third bevel gear meshed with both the first bevel gear and the second bevel gear and a knob fixed to the third bevel gear.
  • the knob rotates, it can drive the third bevel gear.
  • the first bevel gear and the second bevel gear rotate in opposite directions. due to settings With two bending wires, the connecting piece can be bent in two directions, and the bending control component composed of three bevel gears is simple and reliable.
  • the knob When the connecting piece is expected to bend toward the side where the first bending point is located, the knob is turned to make the first bevel gear rotate in the direction in which the first bending wire can be wound around it, thereby tightening the first bending At the same time, the second bevel gear is rotated in a direction that can unwind the second bending wire, thereby relaxing the second bending wire; and vice versa.
  • both the bending member and the driving member are at least partially located within the handle.
  • Such a structure is relatively compact, and there is no need to add components specifically designed to accommodate the bending parts and driving parts.
  • the pump head in the above-mentioned interventional blood pump, includes a rotatable impeller and a driving unit connected to the impeller, the distal end of the bending wire is connected to the proximal end of the driving unit, and the connecting member is hollow interventional catheter.
  • the drive unit is built-in and closer to the impeller. There is no need to connect the two through a long flexible shaft.
  • the transmission efficiency can be improved and the power requirements on the drive unit can be reduced.
  • the drive unit can be greatly improved. It reduces the risk of wear, breakage, and even damage to blood vessels caused by the very long flexible shaft.
  • the impeller in the above-mentioned interventional blood pump, is directly connected to the output shaft of the drive unit or connected to the drive unit through a flexible drive shaft.
  • the pump head further includes a radially expandable conduit covering the outlet of the impeller and extending in the axial direction, and a blood outlet is provided at the proximal end of the radially expandable conduit.
  • a blood flow channel with a larger cross-section can be formed between the radially expandable catheter and the flexible shaft or drive unit. Blood enters the artery from the blood outlet through this channel, reducing energy dissipation at the impeller outlet, reducing pressure loss, and improving the work of the entire pump. efficiency.
  • the interventional catheter in the above-mentioned interventional blood pump, includes a pipeline for accommodating the bending wire.
  • the pipeline is integrated with the wall of the interventional catheter or is an independent pipeline embedded in the inner wall of the interventional catheter. . Because the bending wire is placed in a closed tube, it does not interfere with other components in the interventional catheter.
  • the pump head in the above-mentioned interventional blood pump, includes a rotatable impeller and a radially expandable catheter covering the outlet of the impeller and extending in the axial direction, and the proximal end of the radially expandable catheter is opened
  • the impeller is connected to the drive unit located outside the body during operation through a flexible shaft that passes through the radially expandable catheter;
  • the connector is a flexible shaft, and the distal end of the bending wire is connected to a position of the flexible shaft near the blood outlet.
  • the drive unit is external, so it is less restricted and has greater design freedom.
  • the inner diameter of the expansion catheter can expand during the operation of the blood pump, forming a blood flow channel with a larger cross-section between the expansion catheter and the flexible shaft, thereby ensuring the blood flow area.
  • the blood flowing out from the impeller outlet does not flow directly into the artery, but into the blood flow channel formed between the radially expandable catheter and the flexible shaft after expansion, and then flows from the blood outlet at the proximal end of the radially expandable catheter. Entering the artery, the study found that such a setting prevents the outlet energy from being dissipated due to chaotic blood flow at the impeller outlet, reduces pressure loss, and improves the efficiency of the entire pump.
  • the flexible shaft in the above-mentioned interventional blood pump, includes a flexible shaft for driving the impeller, a flat wire spring tube sleeved outside the flexible shaft, and a sealing soft shaft sleeved outside the flat wire spring tube.
  • tube, the bending wire is located between the sealing hose and the flat wire spring tube, and the distal end of the bending wire is connected to a position of the flat wire spring tube near the blood outlet.
  • the flexible shaft needs to rotate at high speed during the operation of the blood pump, with a maximum rotation speed of nearly 50,000 rpm. When the flexible shaft is bent, the flexible shaft may rub against or wear out the sealed hose, or even damage human tissue.
  • the outermost sealing hose can seal the lubricating fluid used to lubricate and cool the high-speed rotating flexible shaft in the tube to ensure the normal operation of the flexible shaft.
  • the connecting member in the above-mentioned interventional blood pump, is provided with a flexible bending section near the bending point.
  • the bending degree and bending direction of the connecting piece in the flexible bending section can be controlled by the bending mechanism.
  • the specific position, specific number and length of the flexible bending sections can be selected according to actual needs.
  • Figure 1 is a schematic diagram of the overall structure of an interventional blood pump with a bending function according to an embodiment of the present application, in which the interventional catheter is in an unbent state.
  • Figure 2 is a schematic diagram of the overall structure of the interventional blood pump shown in Figure 1, in which the interventional catheter is in a bending state.
  • Figure 3 is a schematic diagram of the overall structure of an interventional blood pump with a bending function according to another embodiment of the present application, in which the flexible shaft is in an unbent state.
  • Figure 4 is a schematic diagram of the overall structure of an interventional blood pump with a bending function according to yet another embodiment of the present application, in which the flexible shaft is in an unbent state.
  • Figure 5 is a schematic cross-sectional view of a bending mechanism according to an embodiment of the present application.
  • Figure 6 is a schematic exploded view of a bending mechanism according to another embodiment of the present application.
  • Figure 7 is a schematic perspective view of the bending mechanism shown in Figure 6, in which the rotating sleeve is not shown.
  • FIG. 8 is a schematic cross-sectional view of the bending mechanism shown in FIG. 6 when the bending wire is in a relaxed state.
  • Figure 9 is a schematic cross-sectional view of the bending mechanism shown in Figure 6 when the bending wire is in a tensioned state.
  • Figure 10 is a schematic cross-sectional view of an interventional catheter according to an embodiment of the present application.
  • Figure 11 is a schematic cross-sectional view of a bending mechanism according to yet another embodiment of the present application.
  • FIG. 12 is a perspective view of the bending control assembly in the bending mechanism shown in FIG. 11 .
  • Figure 13 is a schematic cross-sectional view of a bending mechanism according to yet another embodiment of the present application.
  • FIG. 14 is an exploded schematic view of the bending control assembly in the bending mechanism shown in FIG. 13 .
  • FIG. 15 is a perspective view of the bending control assembly in the bending mechanism shown in FIG. 13 .
  • Figure 16 is a schematic cross-sectional view of the bending mechanism at the distal end of the bending wire according to an embodiment of the present application.
  • Figure 17 is a schematic enlarged cross-sectional view of the bending mechanism near the distal end of the bending wire according to another embodiment of the present application.
  • Figure 18 is a schematic enlarged view of the bending mechanism near the distal end of the bending wire according to another embodiment of the present application.
  • proximal and distal are relative to the operator of an interventional blood pump.
  • the part of a component that is close to the operator is the proximal part. end, the part far away from the operator is the distal end.
  • Figures 1 to 18 show different views of interventional blood pumps according to different embodiments of the present application.
  • These blood pumps can be used as ventricular assist devices (Ventricular Assist Device, VAD) to assist in high-risk percutaneous coronary intervention.
  • VAD ventricular Assist Device
  • the ventricles perform the function of pumping blood.
  • These blood pumps all include a bending mechanism configured to adjust the bending degree and bending direction of the connecting piece connecting the pump head and the handle.
  • the bending mechanism includes one or more bending wires passed through the connector and a bending control component located outside the body during operation. The distal end of the bending wire is connected to the adjusting wire at the proximal end of the pump head.
  • the bending point, the proximal end of the bending wire is connected to the bending control component;
  • the bending control component includes a bending component connected to the bending wire and a driving component that can drive the bending component to perform reciprocating linear motion or rotational motion.
  • the deflection point is radially away from the central axis of the proximal end of the pump head.
  • the degree of bending of the connecting member near the bending point is controlled by adjusting the tightness of the bending wire, and the bending direction of the connecting member is controlled by selecting the position of the bending point.
  • FIGs 1 and 2 schematically illustrate an interventional blood pump according to an embodiment of the present application.
  • the blood pump includes a pump head 100, a handle 8, an interventional catheter 7 connecting the pump head 100 and the handle 8, and a bending mechanism.
  • the bending mechanism includes a bending control assembly 10 and a bending wire 9 installed in the interventional catheter 7 .
  • the interventional catheter 7 is in an unbent state, while in Figure 2, the interventional catheter 7 is in a bent state.
  • the pump head 100 sequentially includes a pigtail catheter 1, a blood inlet 2, a blood pumping catheter 3, a rotatable impeller 4, a blood outlet 5 and a driving unit 6 drivingly connected to the impeller 4 from the distal end to the proximal end.
  • the distal end of the bending wire 9 is connected to the bending point 14 of the proximal end of the driving unit 6 , and the proximal end is connected to the bending control assembly 10 .
  • the distal end of the pigtail catheter 1 is curved, which can prevent the pump head from touching the ventricular wall and causing unnecessary damage. In other embodiments, the pigtail catheter 1 may not be included.
  • the pumping conduit 3 spans the corresponding arterial valve, so that the blood inlet 2 is located in the left ventricle or the right ventricle, the blood outlet 5 is located in the aorta or pulmonary artery, and the rotating impeller 4 moves the blood
  • the flow increases power and assists the ventricle to achieve its pumping function.
  • the drive unit 6 is a built-in motor, such as a coreless motor, and the impeller 4 is directly connected to the output shaft of the motor. But this field The skilled person will understand that any drive unit capable of outputting power and suitable for use in the interventional hospital field (eg, a hydraulic motor) may be used.
  • the interventional catheter 7 is hollow and may contain a cable 71 that supplies power to the driving unit 6 , a cleaning fluid conduit 72 , a sensor optical fiber 73 , and an adjustment cable accommodated in the pipe 75 .
  • the distal end of the interventional catheter 7 is connected to the proximal end of the driving unit 6 , and the proximal end is connected to the handle 8 .
  • the interventional catheter 7 includes a flexible bending section 11 located near the bending point 14 and harder sections located on both sides of the flexible bending section 11 .
  • the flexible bending section 11 is made of materials with lower hardness, such as low-hardness polyurethane, nylon, polyether block polyamide and other medical polymer materials.
  • the harder sections on both sides of the flexible bending section 11 can be made of materials belonging to the same material as the flexible bending section 11 Made of the same type of material, but harder.
  • Metal materials such as braided mesh tubes and spring tubes can be added to the middle layer of the interventional catheter 7 to increase the bending resistance of the catheter.
  • the interventional catheter 7 plays a pushing role. When the pump head 100 is sent to the working position, part of the interventional catheter 7 is located inside the body and part is located outside the body, while the handle 8 and the bending control assembly 10 are located entirely outside the body. , to facilitate the doctor’s operation.
  • FIGS. 6 to 9 schematically illustrate the structure of the bending control assembly 10 of the bending mechanism used in the embodiment shown in FIGS. 1 and 2 .
  • the bending control assembly 10 includes a chute 104, a slider 101 connected to the bending wire 9, a rotating sleeve 102 that can drive the slider 101 to perform reciprocating linear motion in the chute 104, and a The end cap 103 at the end of the chute 104 is used to limit the position of the rotating sleeve 102.
  • the slider 101 has external threads and is axially slidable in the slide groove 104.
  • the rotating sleeve 102 has internal threads and is sleeved outside the slider 101 so that its internal threads are in contact with the external threads of the slider 101.
  • the slide block 101 can be driven to perform reciprocating linear motion in the chute 104, thereby tightening or relaxing the bending wire 9.
  • the bending wire 9 is in a relaxed state, and the interventional catheter 7 is in an unbent state as shown in Figure 1, that is, the distal end of the interventional catheter 7 is
  • the flexible curved section 11 is essentially straight.
  • the slider 101 is driven to move away from the handle 8, so that the bending wire 9 is gradually tightened.
  • the bending wire 9 When the bending wire 9 is tightened, it will exert a bending force on the interventional catheter 7, causing it to adjust in the flexible bending section 11.
  • the side where bend point 14 is located is bent.
  • the bending point 14 is provided at a position radially away from the central axis of the proximal end of the drive unit 6, that is, at the outer periphery of the cross section of the proximal end of the drive unit 6 (see Figures 10 and 16).
  • FIG. 9 shows the state when the slider 101 moves in the direction away from the handle 8 to the end of the stroke. At this time, the bending wire 9 is pulled to the maximum tension.
  • an included angle A is formed between the axis of the bending control assembly 10 and the axis of the handle 8 (see FIG. 4 ).
  • the included angle is greater than 0 degrees and less than 90 degrees. More preferably, the included angle is greater than 0 degrees and less than 90 degrees. 30 degrees and less than 60 degrees. In this way, it is convenient to avoid other components in the handle 8 and make it easier to arrange various conduits (such as cleaning fluid conduits, lubricant fluid conduits, etc.), cables (such as cables that supply power to the drive unit 6), wires (such as sensor pipelines), etc.
  • Figure 5 schematically shows a bending mechanism according to another embodiment.
  • FIG 3 schematically shows an interventional blood pump according to another embodiment of the present application.
  • the blood pump also includes a pump head 100, a handle 8, an interventional catheter 7 connecting the pump head 100 and the handle 8, and a bending mechanism.
  • the pump head 100 sequentially includes a pigtail catheter 1, a blood inlet 2, a rotatable impeller 4, a flexible shaft 7' and an outlet sleeved outside the flexible shaft 7' and covering the impeller 4 from the distal end to the proximal end.
  • the bending mechanism includes a bending control assembly 12 and a first bending wire 91 and a second bending wire 92 that are passed through the interventional catheter 7 .
  • the distal end of the first bending wire 91 is connected to the first bending point 14 at the proximal end of the driving unit 6 , the proximal end is connected to the first rack 122 , and the distal end of the second bending wire 92 is connected to the first bending point 14 of the proximal end of the driving unit 6 .
  • the proximal end of the second bending point 14 is connected to the second rack 123, wherein the first and second bending points are symmetrically arranged along the circumferential direction.
  • a gear 121 meshing with both of the first rack 122 and the second rack 123 is provided, and the knob 124 is fixed to or integrally formed with the gear 121 .
  • the first rack 122 and the second rack 123 can be driven to linearly move in opposite directions, thereby tightening one of the first bending wire 91 and the second bending wire 92 and relaxing the other. . Since two bending wires are provided, the interventional catheter 7 can be bent in two directions. For example, when the knob 124 is turned to tighten the first bending wire 91 and relax the second bending wire 92 , the first bending wire 91 will form a bending force on the interventional catheter 7 , causing it to move toward the flexible bending section 11 .
  • FIG. 16 shows a schematic cross-sectional view of the interventional catheter 7 including two bending wires (other components in the interventional catheter 7 are not shown), in which the first and second bending wires 91, 92 are arranged in conjunction with the interventional catheter 7.
  • the pipe wall of the conduit 7 is integrated into the pipe 75 .
  • FIG 4 schematically shows an interventional blood pump according to another embodiment of the present application.
  • the blood pump includes a pump head 100, a handle 8, a flexible shaft 7' connecting the pump head 100 and the handle 8, a drive unit 6 and a bending adjustment unit. mechanism.
  • the pump head 100 sequentially includes a pigtail catheter 1, a blood inlet 2, a rotatable impeller 4, a flexible shaft 7' and a radially expandable catheter sleeved outside the flexible shaft 7' from the distal end to the proximal end. 20.
  • a blood outlet 5 located at the proximal end of the radially expandable catheter 20.
  • the drive unit 6 is external and the impeller 4 passes through a
  • the flexible shaft 7' extending directly outside the body is drivingly connected to the drive unit 6.
  • a drive unit with a larger power can be used to improve the blood pumping performance of the blood pump. ability.
  • the distal end of the bending wire 9 is connected to the flexible shaft 7' at a location near the blood outlet 5.
  • the bending wire 9 can be disposed between the sealing hose 76' and the flat wire spring tube 74' and the distal end of the bending wire 9 can be connected to the flat wire.
  • the bending point 14 of the spring tube is located near the blood outlet 5 .
  • FIG. 17 schematically shows another embodiment similar to the embodiment shown in FIG. 4 (only part of it is shown), and the only difference between the two is the specific structure of the bending mechanism.
  • the bending mechanism used in this embodiment includes two bending wires 91 and 92, which have a bidirectional bending function.
  • Its bending control component can, for example, have the structure shown in Figures 11 and 12 or the structures shown in Figures 13 to 15 the structure shown.
  • the flexible shaft 7' includes a flexible shaft 72' used to transmit the torque of the driving unit 6 to the impeller 4 and drive it to rotate at high speed, and a flat wire spring tube 74' sleeved outside the flexible shaft 72'. and a sealing hose 76' set outside the flat wire spring tube 72'.
  • the flexible shaft 72' is usually made by braiding multiple (for example, 2 to 6) metal ropes. It can be solid or hollow, and the diameter is preferably 0.5 mm to 1 mm.
  • the flat wire spring tube 74' is usually made of flat wires with a thickness of 0.25-0.55 mm and is spirally wound in a certain rotation direction. It can protect the flexible shaft 72' from being worn during high-speed rotation.
  • the sealing hose 76' may be broken and even human tissue may be harmed.
  • the flat wire spring tube 74' plays a certain rigid supporting role outside the flexible shaft 72', reducing the vibration and swing of the flexible shaft 72' during the working process.
  • both the flat wire spring tube and the flexible shaft are made of metal materials, such as forged stainless steel, nickel-titanium alloy, forged cobalt-chromium-molybdenum alloy, etc.
  • the first bending wire 91 and the second bending wire 92 are both disposed between the sealing hose 76' and the flat wire spring tube 74' and their distal ends are respectively connected to the ends of the flat wire spring tube.
  • the first and second turning points 14 near the blood outlet 5.
  • the distal ends of the first bending wire 91 and the second bending wire 92 are connected to the flat wire spring tube 74' through a retaining ring 93 as shown in Figure 18.
  • Figures 13 to 15 schematically illustrate a bending machine according to yet another embodiment of the present application.
  • the bending mechanism can also be used in the blood pump according to the embodiment shown in FIG. 3 or FIG. 17 .
  • the bending mechanism includes a bending control assembly 13 and a first bending wire 91 and a second bending wire 92 that are inserted into the interventional catheter 7 or the flexible shaft 7'.
  • the distal ends of the first bending wire 91 and the second bending wire 92 are respectively connected to the first and second bending points 14 at the proximal end of the driving unit 6 , or are connected to the flexible shaft 7
  • the proximal ends of the first and second bending points 14 of the 'flat wire spring tube 74' located near the blood outlet 5 are respectively connected to the first bevel gear 131 and the third bevel gear 131 located on both sides of the third bevel gear 134 and meshed with them.
  • the second bevel gear 132 and the knob 133 are fixed to the third bevel gear 134 or are integrally formed with them, wherein the first and second bending points 14 are symmetrically arranged along the circumferential direction.
  • the first bevel gear 131 , the second bevel gear 132 , the third bevel gear 134 and the knob 133 are all located in the handle 8 .
  • the handle 8 is provided with a through opening 85 in a shape such as an ellipse or an oblong shape. At least a part of the knob 133 is exposed from the opening 85 to facilitate the operator to rotate the knob when the blood pump needs to be adjusted. 133.
  • the knob 133 When the knob 133 is turned, it drives the third bevel gear 134 to rotate, which in turn drives the first bevel gear 131 and the second bevel gear 132 to rotate in opposite directions, thereby causing the first bending wire 91 and the second bending wire 92 to rotate.
  • One is tightened by being wound onto the bevel gear, and the other is relaxed by unwinding.
  • the interventional catheter 7 or the flexible shaft 7' can be bent in two directions, that is, by making the first bending wire 91 or the second bending wire 92 in a tensioned state, the interventional catheter 7 or the flexible shaft 7' can be bent in a tensioned state.
  • the flexible bending section 11 bends toward the side where the tensioned bending wire is located.
  • the bending mechanism may also have a different structure from that described in the above embodiment, as long as the connection member connecting the pump head and the handle (such as a hollow interventional catheter or a flexible shaft for transmission) can be adjusted. ) of the curvature and curvature direction; the pump head can also have other structures.
  • the various pump heads and various bending mechanisms described in the above embodiments can be combined at will without conflict to obtain new embodiments not described in this application.
  • the bending mechanism in the embodiment of Fig. 1 can be replaced with the bending mechanism in the embodiment of Fig. 5, Fig. 11 or Fig. 13, or the pump head in the embodiment of Fig. 1 can be replaced with the embodiment of Fig. 3 or 4.
  • the bending mechanism only includes one or two bending rods in the above embodiments, wires, but in other embodiments, the bending mechanism may include three or more bending wires. In this case, only the structure of the bending control assembly needs to be changed accordingly to achieve multi-directional bending.

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

Abstract

La présente invention concerne une pompe à sang interventionnelle qui comprend une tête de pompe (100), une poignée (8), et un élément de liaison servant à relier la tête de pompe (100) et la poignée (8). Lorsque la tête de pompe (100) est en position de fonctionnement dans le cœur, la poignée (8) est située à l'extérieur du corps, et l'élément de liaison est au moins partiellement situé dans le corps. La pompe à sang interventionnelle comprend en outre un mécanisme de réglage de la flexion. Le mécanisme de réglage de la flexion est conçu pour pouvoir régler le degré de flexion et la direction de flexion de l'élément de liaison. La pompe à sang interventionnelle de la présente demande a la capacité de régler la flexion, peut mieux s'adapter à une structure de vaisseau sanguin incurvée pendant l'intervention, présente une bonne capacité de passage, peut réduire le frottement entre une extrémité distante d'un cathéter et une paroi de vaisseau sanguin, ce qui permet de réduire les dommages subis par un vaisseau sanguin, peut être plus facilement placée dans une position attendue idéale, et sa position peut continuer à être ajustée au moyen du mécanisme de réglage de la flexion après mise en place jusqu'à ce que la position de la tête de pompe soit ajustée au mieux.
PCT/CN2023/097223 2022-08-18 2023-05-30 Pompe à sang interventionnelle avec fonction de réglage de la flexion WO2024037105A1 (fr)

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CN202210992709.9A CN116262158A (zh) 2022-08-18 2022-08-18 具有调弯功能的介入式血泵
CN202210992709.9 2022-08-18

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110037760A (zh) * 2019-05-30 2019-07-23 北京华脉泰科医疗器械有限公司 操作手柄及医用可调弯鞘管
US20200246527A1 (en) * 2018-10-05 2020-08-06 Daniel Hildebrand Intravascular blood pumps and methods of use
CN211486137U (zh) * 2019-11-22 2020-09-15 茵络(无锡)医疗器械有限公司 一种用于介入治疗的调弯导管及调弯装置
CN114225214A (zh) * 2022-01-11 2022-03-25 丰凯利医疗器械(上海)有限公司 导管泵壳体结构以及导管泵装置
CN114404779A (zh) * 2021-12-29 2022-04-29 中国医学科学院阜外医院 角度可调型心血管介入泵用心室导管
CN114642827A (zh) * 2020-12-17 2022-06-21 苏州心岭迈德医疗科技有限公司 心室辅助泵血器械及系统
CN114680954A (zh) * 2020-12-31 2022-07-01 先健科技(深圳)有限公司 可调弯医用装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200246527A1 (en) * 2018-10-05 2020-08-06 Daniel Hildebrand Intravascular blood pumps and methods of use
CN110037760A (zh) * 2019-05-30 2019-07-23 北京华脉泰科医疗器械有限公司 操作手柄及医用可调弯鞘管
CN211486137U (zh) * 2019-11-22 2020-09-15 茵络(无锡)医疗器械有限公司 一种用于介入治疗的调弯导管及调弯装置
CN114642827A (zh) * 2020-12-17 2022-06-21 苏州心岭迈德医疗科技有限公司 心室辅助泵血器械及系统
CN114680954A (zh) * 2020-12-31 2022-07-01 先健科技(深圳)有限公司 可调弯医用装置
CN114404779A (zh) * 2021-12-29 2022-04-29 中国医学科学院阜外医院 角度可调型心血管介入泵用心室导管
CN114225214A (zh) * 2022-01-11 2022-03-25 丰凯利医疗器械(上海)有限公司 导管泵壳体结构以及导管泵装置

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