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WO2025147860A1 - Dispositif d'assistance ventriculaire percutanée pulsatile et valve bidirectionnelle associée - Google Patents

Dispositif d'assistance ventriculaire percutanée pulsatile et valve bidirectionnelle associée

Info

Publication number
WO2025147860A1
WO2025147860A1 PCT/CN2024/071427 CN2024071427W WO2025147860A1 WO 2025147860 A1 WO2025147860 A1 WO 2025147860A1 CN 2024071427 W CN2024071427 W CN 2024071427W WO 2025147860 A1 WO2025147860 A1 WO 2025147860A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
leaf
valve leaf
inner cavity
valve body
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/CN2024/071427
Other languages
English (en)
Chinese (zh)
Inventor
娄厦
巴好财
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mcs Medical Technology Shanghai Co Ltd
Original Assignee
Mcs Medical Technology Shanghai Co Ltd
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 Mcs Medical Technology Shanghai Co Ltd filed Critical Mcs Medical Technology Shanghai Co Ltd
Priority to PCT/CN2024/071427 priority Critical patent/WO2025147860A1/fr
Publication of WO2025147860A1 publication Critical patent/WO2025147860A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood

Definitions

  • the present invention relates to the technical field of ventricular assist devices, and in particular to a two-way valve and a pulsating interventional ventricular assist device using the two-way valve.
  • An interventional ventricular assist device usually connects a ventricular assist pump to the left ventricle through an interventional catheter, and sets a two-way valve on the interventional catheter, which is located in the ascending aorta.
  • An external diaphragm pump with a set pulse frequency and a catheter connected via a connector are used to extract and reinject blood, and the two-way valve is used to guide blood flow: when blood is extracted, the blood in the left ventricle flows into the external diaphragm pump through the interventional catheter and the two-way valve; when blood is reinjected, the blood in the diaphragm pump is pressurized and flows into the interventional catheter.
  • the two-way valve automatically switches due to pressure, allowing blood to be ejected from the catheter into the aorta. This achieves left ventricular assistance.
  • the performance of the bidirectional valve is crucial to the operation of the interventional ventricular assist device. Improving the bidirectional valve to enhance and optimize its switching response and sealing effect can enhance and optimize the working capacity and operation of the interventional ventricular assist device.
  • the technical problem to be solved by the present invention is to provide a two-way valve with stable opening and closing, which has better switching response and sealing effect.
  • the present invention adopts the following technical solutions:
  • the valve body can be switched back and forth between the open position and the closed position; in the open position, the second valve leaf, the first valve leaf and the third valve leaf jointly separate the proximal port and the distal port, the opening window is opened and connected to the distal port; in the closed position, the first valve leaf closes the opening window, and the proximal port and the distal port are connected.
  • the edge of the first valve leaf and the edge of the third valve leaf are connected to form a first side edge away from the second valve leaf, and the second valve leaf has a second side edge away from the first valve leaf.
  • the first side edge is tangent to the inner cavity wall, and the second side edge contacts the inner cavity wall and closes the end of the opening window close to the proximal port.
  • the window includes a first beveled window surface, a flat cut window surface and a second beveled window surface which are connected in sequence and formed by continuous cutting on the valve body.
  • the first beveled window surface and the second beveled window surface form an angle or are parallel to each other.
  • Two flat cut window surfaces are formed, and both flat cut window surfaces are parallel to the axis of the valve body and symmetrical about a center line of symmetry.
  • connecting parts are respectively provided at both ends of the first valve leaf, and the connecting parts are rotatably connected to the valve body through a pin shaft.
  • the axis of the pin shaft is perpendicular to the axis of the valve body and the plane where the symmetry center lines of the two parallel window surfaces are located.
  • the axis of the pin shaft intersects with the axis of the valve body, or the axis of the pin shaft is offset to the side of the axis of the valve body away from the window.
  • the angle between the first oblique cut window surface and the vertical plane perpendicular to the axis of the valve body is 0-45°
  • the angle between the second oblique cut window surface and the vertical plane perpendicular to the axis of the valve body is 0-80°
  • the valve body has a middle section, and the window is arranged in the middle section.
  • the cross-sectional shape of the outer peripheral contour of the middle section is an arc shape with a maximum diameter distance of D.
  • the length of the flat cut window surface extending along the axial direction of the valve body is P, and the length P is 0.5D-1.5D.
  • the maximum length of the window extending along the axial direction of the valve body is O, and the length O is 0.8D-2D.
  • the ratio of the length P to the length O is 1/4-1.
  • a side portion of the first valve leaf away from the second valve leaf abuts against the wall of the inner cavity.
  • the included angle between the first valve leaf and the third valve leaf is 120°-175°.
  • the present invention also provides a pulsating interventional ventricular assist device, which uses the bidirectional valve as described above.
  • the two-way valve of the present invention drives the valve flap to rotate by the first valve leaf and the second valve leaf of the valve flap when the blood flow direction changes, so that the valve flap automatically rotates and switches between the closed position and the open position in accordance with the change of blood flow direction, and can achieve timely and reliable switching response.
  • the angle of attack of the first valve leaf to the blood flow is increased when the blood flows from the distal port of the inner cavity to the proximal port, thereby increasing the force and torque on the valve flap under the action of the blood flow, so that the response speed of the valve flap from the closed position to the open position becomes faster; at the same time, the valve flap closes the open window on the valve body in the closed position and separates the proximal port and the distal port of the inner cavity in the open position, and the valve flap is kept in the closed position or the open position by the impact of the blood flow, so that a reliable and stable closing effect can be achieved. Therefore, the two-way valve of the present invention can achieve stable opening and closing, better switching response and closing effect, and has better blood flow guiding ability.
  • FIG1 is a schematic diagram of the three-dimensional structure of a valve body of a two-way valve according to a first embodiment of the present invention.
  • FIG. 4 is a schematic front view of a valve flap of a two-way valve according to the first embodiment of the present invention.
  • FIG. 5 is a schematic top view of the valve disc of the two-way valve according to the first embodiment of the present invention.
  • FIG6 is a cross-sectional schematic diagram of the valve flap of the two-way valve in the closed position according to the first embodiment of the present invention.
  • FIG. 7 is a three-dimensional schematic diagram of the two-way valve according to the first embodiment of the present invention, with the valve flap in the open position.
  • FIG8 is a top view of the two-way valve according to the first embodiment of the present invention, with the valve flap in the open position.
  • Fig. 9 is a schematic cross-sectional view along the A-A direction in Fig. 8 .
  • FIG. 10 is a left side schematic diagram of the two-way valve of Embodiment 1 of the present invention, when the valve flap is in an open position.
  • FIG. 11 is a three-dimensional schematic diagram of the two-way valve of Embodiment 1 of the present invention, with the valve flap in the closed position.
  • FIG. 12 is a top view of the two-way valve according to the first embodiment of the present invention, with the valve flap in the closed position.
  • Fig. 13 is a schematic cross-sectional view along the B-B direction in Fig. 12 .
  • FIG. 14 is a left side schematic diagram of the two-way valve of the first embodiment of the present invention, when the valve flap is in the closed position.
  • FIG. 17 is a schematic front view of the valve flap of the two-way valve according to the second embodiment of the present invention.
  • FIG. 20 is a cross-sectional schematic diagram of the two-way valve of the second embodiment of the present invention, when the valve flap is in the open position.
  • 21 is a cross-sectional schematic diagram of the two-way valve of the second embodiment of the present invention, when the valve disc is in the closed position.
  • FIG. 22 is a schematic diagram of the structure of a pulsatile interventional ventricular assist device according to Embodiment 3 of the present invention.
  • the terms “installed”, “connected”, and “connected” should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components.
  • installed should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components.
  • the two-way valve of this embodiment 1 includes a valve body 1 and a valve flap 2 .
  • the valve body 1 is axially connected to form an inner cavity 10, and the inner cavity 10 has a proximal port 1a and a distal port 1b that are opposite and connected to each other along the axial direction of the valve body 1.
  • the valve body 1 is provided with an opening 1c between the proximal port 1a and the distal port 1b, and the opening 1c connects the inner cavity 10 of the valve body 1 with the outside of the valve body 1.
  • the valve flap 2 is arranged in the inner cavity 10 of the valve body 1, and the valve flap 2 is rotatably connected to the valve body 1.
  • the valve flap 2 includes a first valve leaf 21, a second valve leaf 22 and a third valve leaf 23.
  • the second valve leaf 22, the first valve leaf 21 and the third valve leaf 23 are connected in sequence, the first valve leaf 21 and the second valve leaf 22 are connected at an obtuse angle, and the first valve leaf 21 and the third valve leaf 23 are connected at an obtuse angle.
  • the first valve leaf 21 is arranged at the window opening 1c of the inner cavity 10 of the valve body 1, and the first valve leaf 21 is used to close the window opening 1c.
  • the second valve leaf 22 is arranged at one end of the first valve leaf 21 close to the proximal port 1a of the inner cavity 10 of the valve body 1, and the second valve leaf 22 is located on the side of the first valve leaf 21 close to the inner cavity 10 of the valve body 1.
  • the third valve leaf 23 is arranged at one end of the first valve leaf 21 close to the distal port 1b of the inner cavity 10 of the valve body 1, and the second valve leaf 22 is located on the side of the first valve leaf 21 close to the inner cavity 10 of the valve body 1.
  • the valve flap 2 is impacted by the blood flow axially flowing in the inner cavity 10 and rotates back and forth between the open position and the closed position.
  • the two-way valve guides the blood flow from the distal port 1b of the inner cavity 10 to the opening window 1c.
  • the impact of the blood flow on the third valve leaf 23 and the first valve leaf 21 of the valve flap 2 can keep the valve flap 2 in the open position.
  • the blood flow direction changes to flow from the proximal port 1a of the inner cavity 10 to the distal port 1b
  • the blood flow reversely impacts the first valve leaf 21 and the third valve leaf 23 of the valve flap 2, giving the first valve leaf 21 and the third valve leaf 23 a force to rotate toward the outside of the inner cavity 10, causing the valve flap 2 to rotate toward the closed position.
  • the second valve leaf 22 rotates toward the inside of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a role in blocking the flow, and can further drive the valve flap 2 to rotate faster until it reaches the closed position.
  • the first valve leaf 21 of the valve flap 2 in the closed position, is located at the window opening 1c, and the second valve leaf 22 and the third valve leaf 23 of the valve flap 2 are both located in the inner cavity 10 of the valve body 1.
  • the first valve leaf 21 of the valve flap 2 closes the window opening 1c, and the proximal port 1a and the distal port 1b are connected, so that the inner cavity 10 of the valve body 1 is conductive, and blood can flow axially from the inner cavity 10 through the valve body 1.
  • the two-way valve guides the blood flow from the proximal port 1a of the inner cavity 10 to the distal port 1b, and the blood flow acts on the valve flap 2.
  • the impact of the second valve leaf 22 and the third valve leaf 23 can keep the valve flap 2 in the closed position.
  • the angle area between the side of the third valve leaf 23 facing the outer side of the inner cavity 10 and the wall of the inner cavity 10 forms a flow blocking area, which constitutes the angle of attack of the first valve leaf 21 to the blood flow.
  • the blood flow enters the flow blocking area and impacts the third valve leaf 23 of the valve flap 2 in the reverse direction, giving the third valve leaf 23 a force to rotate toward the inner side of the inner cavity 10, so that the valve flap 2 rotates toward the open position.
  • the first valve leaf 21 rotates toward the inner side of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a flow blocking role, and can further drive the valve flap 2 to rotate faster until it reaches the open position.
  • the two-way valve of the first embodiment of the present invention drives the valve flap 2 to rotate by the blood flow impacting the first valve leaf 21 and the third valve leaf 23 of the valve flap 2 when the blood flow direction changes, so that the valve flap 2 automatically rotates and switches between the closed position and the open position in accordance with the change of blood flow direction, and timely and reliable switching response can be achieved.
  • the angle of attack of the first valve leaf 21 to the blood flow is increased when the blood flows from the distal port 1b of the inner cavity 10 to the proximal port 1a, thereby increasing the force and torque on the valve flap 2 under the action of the blood flow, so that the response speed of the valve flap 2 from the closed position to the open position becomes faster; at the same time, the valve flap 2 closes the open window 1c on the valve body 1 in the closed position and separates the proximal port 1a and the distal port 1b of the inner cavity 10 in the open position, and the valve flap 2 is kept in the closed position or the open position due to the impact of the blood flow, so that a reliable and stable closing effect can be achieved. Therefore, the two-way valve of the first embodiment can achieve stable opening and closing as well as better switching response and sealing effect, and has better blood flow guiding capability.
  • the two-way valve of the first embodiment can be used for an interventional ventricular assist device.
  • the two-way valve When in use, the two-way valve is installed on an interventional catheter and placed in the aorta.
  • the proximal port 1a of the inner cavity 10 of the valve body 1 is connected to the left ventricle through a section of the interventional catheter, and the distal port 1b of the inner cavity 10 of the valve body 1 is connected to the ventricular assist pump through another section of the interventional catheter.
  • the opening window 1c on the valve body 1 faces the aorta.
  • the ventricular assist pump draws out blood
  • the blood in the left ventricle flows from the proximal port 1a of the inner cavity 10 of the valve body 1 to the distal port 1b, causing the valve flap 2 to rotate to and remain in the closed position
  • the two-way valve guides the blood flow from the left ventricle through the proximal port 1a and the distal port 1b of the inner cavity 10 of the valve body 1 to flow into the ventricular assist pump
  • the ventricular assist pump reinjects blood
  • the blood in the ventricular assist pump flows from the distal port 1b of the inner cavity 10 of the valve body 1 to the proximal port 1a, causing the valve flap 2 to rotate to and remain in the open position
  • the two-way valve guides the blood flow from the ventricular assist pump through the distal port 1b of the inner cavity 10 of the valve body 1 and the window 1c of the valve body 1 to be ejected to the aorta, thereby achieving blood circulation assistance.
  • the first valve leaf 21 and the second valve leaf 22 have a smooth transition, the first arc-shaped convex surface 211 of the first valve leaf 21 and the second arc-shaped convex surface 221 of the second valve leaf 22 are smoothly connected, and the first arc-shaped concave surface 212 of the first valve leaf 21 and the second arc-shaped concave surface 222 of the second valve leaf 22 are smoothly connected;
  • the first valve leaf 21 and the third valve leaf 23 have a smooth transition, the first arc-shaped convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23 are smoothly connected, and the first arc-shaped concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23 are smoothly connected. This can make the blood flow relatively smooth each time it flushes, while reducing the formation of blood clots in small spaces.
  • the first arcuate convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23 act as flow-blocking surfaces, and are impacted by the blood flow flowing in from the distal port 1b of the inner cavity 10, so that the valve flap 2 is kept in the open position and the blood flow is guided from the distal port 1b of the inner cavity 10 to the opening window 1c.
  • the first arcuate concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23 act as flow-blocking surfaces, and are impacted by the blood flow, so that the valve flap 2 is driven to rotate toward the closed position.
  • the second valve leaf 22 gradually intervenes in the blood flow, and the second arcuate convex surface 221 of the second valve leaf 22 can also play a flow-blocking role until the valve flap 2 rotates to the closed position.
  • the second arcuate convex surface 221 of the second valve leaf 22 and the second surface 232 of the third valve leaf 23 act as flow blocking surfaces, and are impacted by the blood flow flowing from the proximal port 1a to the distal port 1b of the inner cavity 10 of the valve body 1, so that the valve flap 2 is kept in the closed position.
  • the first surface 231 of the third valve leaf 23 acts as a flow blocking surface, and is impacted by the blood flow, driving the valve flap 2 to rotate toward the open position.
  • the first valve leaf 21 gradually intervenes in the blood flow, and the first arcuate convex surface 211 of the first valve leaf 21 also plays a flow blocking role until the valve flap 2 rotates to the open position.
  • the first valve leaf 21, the second valve leaf 22 and the third valve leaf 23 all adopt an arc-shaped sheet structure, so that the surface that blocks the blood flow is an arc-shaped convex surface or an arc-shaped concave surface, which is beneficial to improving the blood flow blocking effect, realizing continuous diversion, minimizing the damage and impact on the blood flow, and is beneficial to blood flow stability and blood flow permeability. It is not easy to cause turbulence, and can simplify the flow channel while meeting the functional requirements. It is more in line with hemodynamics and can reduce the risk of thrombosis.
  • valve flap 2 of the first embodiment of the present invention has an arc-shaped first valve leaf 21 and an edge thereof connected to an edge of an arc-shaped third valve leaf 23 to form a first side edge 2a away from the second valve leaf 22, and the arc-shaped second valve leaf 22 has a second side edge 2b away from the first valve leaf 21.
  • the second valve leaf 22 when the valve flap 2 is in the open position, the second valve leaf 22 is located at one end of the opening window 1c close to the proximal port 1a of the inner cavity 10 and occupies part of the space of the opening window 1c, and the end of the opening window 1c close to the distal port 1b of the inner cavity 10 is connected to the distal port 1b of the inner cavity 10 to supply blood to be ejected out of the opening window 1c.
  • the valve flap 2 when the valve flap 2 is in the open position and the first side edge 2a tangent to the cavity wall of the inner cavity 10 and the second side edge 2b rotate to the closed position of the valve flap 2, there is a gap between the cavity wall of the inner cavity 10, so as to facilitate the smooth rotation of the valve flap 2 in the cavity 10 of the valve body 1.
  • the gap between the first side edge 2a and the cavity wall of the inner cavity 10 does not affect the closure of the first valve leaf 21 to the open window 1c, and there is a gap between the second side edge 2b and the cavity wall of the inner cavity 10.
  • the blood leakage is very small and does not affect the blood in the left ventricle flowing into the ventricular assist pump when blood is pumped out.
  • the cross-sectional shape of the wall of the inner cavity 10 of the valve body 1 is preferably circular, and the edge contour of the first valve leaf 21 and the edge contour of the third valve leaf 23 constituting the first side edge 2a and the second side edge 2b contour of the second valve leaf 22 are all ellipses that can be obliquely cut and match the wall of the inner cavity 10.
  • the angle between the first valve leaf 21 and the second valve leaf 22 of the valve flap 2 is ⁇ 1, which is the angle between the first curved convex surface 211 of the first valve leaf 21 and the second curved convex surface 221 of the second valve leaf 22, and is also the angle between the first curved concave surface 212 of the first valve leaf 21 and the second curved concave surface 222 of the second valve leaf 22.
  • the value of the angle ⁇ 1 is preferably 100°-160°, which is more conducive to relatively smooth blood flow each time it is flushed and reducing the formation of blood clots in narrow spaces.
  • the angle between the first valve leaf 21 and the third valve leaf 23 of the valve flap 2 is ⁇ 2.
  • the angle ⁇ 2 is the angle between the first arc-shaped convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23, and is also the angle between the first arc-shaped concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23.
  • the value of the angle ⁇ 1 is preferably 120°-175°, which is more conducive to relatively smooth blood flow each time it is flushed and reducing the formation of blood clots in a narrow space.
  • Two flat cut window surfaces 1c2 are formed between the first oblique cut window surface 1c1 and the second oblique cut window surface 1c3.
  • the first oblique cut window surface 1c1, the two flat cut window surfaces 1c2 and the second oblique cut window surface 1c3 are connected to form a closed ring.
  • the two flat cut window surfaces 1c2 are parallel to the axis of the valve body 1, and the two flat cut window surfaces 1c2 are symmetrical about a symmetric center line.
  • the side of the first valve leaf 21 away from the second valve leaf 22 is located on the inner side of the second oblique cut window surface 1c3 of the opening window 1c and closes the end of the opening window 1c close to the distal end 1b.
  • the arc-shaped sheet-shaped first valve leaf 21 can form a relatively complete inner cavity 10 with the valve body 1 at the opening window 1c, thereby increasing the blood discharge volume when blood is drawn.
  • the two ends of the first valve leaf 21 are respectively provided with connecting parts 21b, and the two ends of the first valve leaf 21 refer to the two ends of the arc-shaped sheet-shaped first valve leaf 21 type line (arc line), and the first side edge 2a and the second side edge 2b of the valve flap 2 are connected through the edges of the two connecting parts 21b to form a closed edge profile.
  • the two connecting parts 21b of the first valve leaf 21 are respectively rotatably connected to the valve body 1 through the pin 3, and the axis of the pin 3 is perpendicular to the axis of the valve body 1 and the plane where the symmetry center lines of the two plane-cut window surfaces 1c2 are located.
  • the axis of the pin 3 is perpendicular to the axis of the valve body 1 and the plane where the symmetry center lines of the two plane-cut window surfaces 1c2 are located.
  • the axes intersect, and the axis of the pin shaft 3 (i.e., the rotation center of the valve flap 2) is set on the axis of the valve body 1, which fully considers the structure and movement of the valve flap 2, while taking into account the fluid mechanics of the valve flap 2, and can ensure smooth rotation and switching of the valve flap 2.
  • the axis of the pin shaft 3 can also be offset to the side of the axis of the valve body 1 far away from the window 1c.
  • the pin shaft 3 is eccentrically arranged with the axis of the valve body 1 on the side of the axis of the valve body 1 far away from the window 1c, which is conducive to increasing the blood flow impact torque on the second arc convex surface 221 of the second valve leaf 22 that gradually intervenes in the blood flow during the rotation of the valve flap 2 from the open position to the closed position, so that the valve flap 2 quickly rotates to the closed position and stably remains in the closed position.
  • the distance of the pin shaft 3 from the axis of the valve body 1 on the side of the axis of the valve body 1 far away from the window 1c is preferably 0.1mm-1mm.
  • the closed position of the valve flap 2 can be limited, and the side of the first valve leaf 21 away from the second valve leaf 22 can be abutted against the wall of the inner cavity 10 to achieve the first valve leaf 21 away from the second valve leaf 22 to close the end of the window 1c close to the distal end 1b, that is, the first valve leaf 21 closes the window 1c when the valve flap 2 is in the closed position.
  • the side of the first valve leaf 21 away from the second valve leaf 22 and the wall of the inner cavity 10 of the valve body 1 have an overlapping length X in the axial direction, and the overlapping length X can make the first valve leaf 21 abut against the wall of the inner cavity 10 when rotating toward the outside of the inner cavity 10, thereby limiting the first valve leaf 21 in the closed position.
  • the first valve leaf 21 , the second valve leaf 22 and the third valve leaf 23 of the valve flap 2 are integrally formed as one piece.
  • the above-mentioned size parameters of the two-way valve of the first embodiment are not limited and can be further adjusted and optimized according to actual usage.
  • the second embodiment of the two-way valve provided by the present invention.
  • This second embodiment is basically the same as the first embodiment, and the similarities are not repeated here.
  • the difference is that the shape of the third valve leaf 23 of the valve flap 2 in the second embodiment is different from that in the first embodiment.
  • the third valve leaf 23 is a slightly arched plane sheet structure. In the closed position, the third valve leaf 23 is slightly convex toward the proximal port 1a of the inner cavity 10 of the valve body 1, that is, the third valve leaf 23 is a plane sheet shape that is slightly convex toward the proximal port 1a of the inner cavity 10 of the valve body 1.
  • the first surface 231 is an approximate plane that is slightly concave toward the distal port 1b of the inner cavity 10
  • the second surface 232 is an approximate plane that is slightly convex toward the proximal port 1a of the inner cavity 10.
  • the length of the third valve leaf 23 is L3, which refers to the interval length between the end of the third valve leaf 23 connected to the first valve leaf 21 and the side tip of the end of the third valve leaf 23 away from the first valve leaf 21.
  • the angle ⁇ 2 between the first valve leaf 21 and the third valve leaf 23 is the angle between the length extension line of the third valve leaf 23 and the first valve leaf 21.
  • the third valve leaf 23 in this Example 2 adopts a micro-arched flat sheet structure or a flat sheet structure, which can further increase the angle of attack of the first valve leaf 21 to the blood flow when the blood flows from the distal port 1b of the inner cavity 10 to the proximal port 1a, reduce blood flow diversion, and make the valve flap 2 subject to greater force and torque under the action of blood flow, and the response speed of the valve flap 2 to switch from the closed position to the open position is faster and more agile.
  • the present invention also provides a pulsating interventional ventricular assist device.
  • Example 3 provides an embodiment of the pulsating interventional ventricular assist device of the present invention.
  • the pulsating interventional ventricular assist device of this Example 3 adopts any one of the two-way valves described in the above-mentioned Example 1 and Example 2. Since the two-way valve can achieve stable opening and closing and better switching response and sealing effect, and has better blood flow guiding ability, the working ability and operation effect of the pulsating interventional ventricular assist device of this Example 3 are effectively improved and optimized.
  • the ventricular catheter 100 is delivered to the left ventricle of the heart 600 via the femoral artery 500, one end of the ventricular catheter 100 is connected to the left ventricle, and the other end of the ventricular catheter 100 is preferably connected to the proximal section 12 of the two-way valve 200 by bonding or injection molding, so as to communicate with the proximal port 1a of the inner cavity 10 of the valve body 1.
  • the two-way valve 200 is located in the aorta 700.
  • the diameter of the peripheral catheter 300 is consistent with that of the ventricular catheter 100.
  • One end of the peripheral catheter 300 is preferably connected to the distal section 13 of the two-way valve 200 by bonding or injection molding, so as to communicate with the distal port 1b of the inner cavity 10 of the valve body 1.
  • the other end of the peripheral catheter 300 is preferably connected to the pump 400 by bonding.
  • the pump 400 is preferably a diaphragm pump, which extracts and reinjects blood at a set pulsation frequency under the control and drive of an external control device.
  • the diaphragm pump and its external control device can both use existing equipment, which will not be described in detail herein.
  • the blood flows into the first arc-shaped concave surface 212 of the first valve leaf 21 of the valve flap 2, the second surface 232 of the third valve leaf 23, and the second arc-shaped convex surface 221 of the second valve leaf 22, driving the first valve leaf 21 of the valve flap 2 to rotate around the pin shaft 3 toward the outside of the inner cavity 10 of the valve body 1 to the closed position, closing the window 1c of the valve body 1, and the blood flows from the proximal port 1a to the distal port 1b of the inner cavity 10 of the valve body 1, and is sucked to the pump through the peripheral catheter 300.
  • the external control device sets a pulse for the pump 400, so that the blood in the pump 400 is injected back into the peripheral catheter 300 and enters the two-way valve 200.
  • the valve flap 2 When the blood just enters the distal port 1b of the inner cavity 10 of the valve body 1, the valve flap 2 is still in the closed position.
  • the blood flows reversely into the inner cavity 10 of the valve body 1, it impacts the first surface 231 of the third valve leaf 23 of the valve flap 2 and the first arc-shaped convex surface 211 of the first valve leaf 21, driving the first valve leaf 21 of the valve flap 2 to rotate around the pin shaft 3 toward the inner side of the inner cavity 10 of the valve body 1 to the open position.
  • the myocardium is in diastole, the blood is ejected laterally from the open window 1c of the valve body 1 to the aorta 700, completing a cycle.

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  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne une valve bidirectionnelle et un dispositif d'assistance ventriculaire percutanée pulsatile correspondant. La valve bidirectionnelle comprend : un corps de valve (1) avec une cavité interne (10) traversante, la cavité interne étant pourvue d'un orifice proximal (1a) et d'un orifice distal (1b), et le corps de valve (1) étant pourvu d'une fenêtre ouverte (1c) en communication avec la cavité interne (10) et l'extérieur du corps de valve (1) ; et un clapet de valve (2) disposé dans la cavité interne (10) et relié de manière rotative au corps de valve (1), le clapet de valve (2) comprenant une première lamelle de valve (21), une deuxième lamelle de valve (22) et une troisième lamelle de valve (23), qui sont reliées selon un angle obtus, la première lamelle de valve (21) étant disposée au niveau de la fenêtre ouverte (1c), la deuxième lamelle de valve (22) étant disposée sur un côté à proximité de la cavité interne (10) à une extrémité de la première lamelle de valve (21) au voisinage de l'orifice proximal (1a), et la troisième lamelle de valve (23) étant disposée sur un côté à proximité de la cavité interne à une extrémité de la première lamelle de valve au voisinage de l'orifice distal (1b). Le clapet de valve (2) est soumis à l'impact du flux sanguin qui s'écoule axialement dans la cavité interne (10) et est commuté en rotation en va-et-vient entre une position ouverte et une position fermée. Dans la position ouverte, les trois lamelles de valve séparent ensemble l'orifice proximal (1a) et l'orifice distal (1b), et la fenêtre ouverte (1c) est ouverte et en communication avec l'orifice distal (1b). Dans la position fermée, la première lamelle de valve (21) ferme la fenêtre ouverte (1c), et l'orifice proximal (1a) est en communication avec l'orifice distal (1b), ce qui permet d'obtenir une meilleure réponse de commutation et un effet d'étanchéité amélioré.
PCT/CN2024/071427 2024-01-09 2024-01-09 Dispositif d'assistance ventriculaire percutanée pulsatile et valve bidirectionnelle associée Pending WO2025147860A1 (fr)

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PCT/CN2024/071427 WO2025147860A1 (fr) 2024-01-09 2024-01-09 Dispositif d'assistance ventriculaire percutanée pulsatile et valve bidirectionnelle associée

Applications Claiming Priority (1)

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PCT/CN2024/071427 WO2025147860A1 (fr) 2024-01-09 2024-01-09 Dispositif d'assistance ventriculaire percutanée pulsatile et valve bidirectionnelle associée

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WO2025147860A1 true WO2025147860A1 (fr) 2025-07-17

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120789471A (zh) * 2025-09-11 2025-10-17 脉柯斯医疗科技(绍兴)有限公司 双向阀和心室辅助介入装置
CN120789471B (en) * 2025-09-11 2025-12-16 脉柯斯医疗科技(绍兴)有限公司 Bi-directional valve and ventricular assist intervention device

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US5156600A (en) * 1990-10-10 1992-10-20 Strato Medical Corporation Bidirectional check valve catheter
US20020123661A1 (en) * 1999-07-29 2002-09-05 Verkerke Gijsbertus Jacob Catheter pump, catheter and method for supporting organ perfusion
US20050085684A1 (en) * 2003-09-02 2005-04-21 Gerhard Rakhorst Catheter pump, catheter and fittings therefore and methods of using a catheter pump
CN103459905A (zh) * 2011-03-01 2013-12-18 康诺特莱索瑟维斯有限公司 阀插入件
US20220265994A1 (en) * 2021-02-23 2022-08-25 Ventriflo, Inc. Pump-Valving Assembly for a Pulsatile Fluid Pump
CN116370818A (zh) * 2023-03-24 2023-07-04 上海化创医疗科技有限公司 心脏循环辅助装置及循环辅助系统

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5156600A (en) * 1990-10-10 1992-10-20 Strato Medical Corporation Bidirectional check valve catheter
US20020123661A1 (en) * 1999-07-29 2002-09-05 Verkerke Gijsbertus Jacob Catheter pump, catheter and method for supporting organ perfusion
US20050085684A1 (en) * 2003-09-02 2005-04-21 Gerhard Rakhorst Catheter pump, catheter and fittings therefore and methods of using a catheter pump
CN103459905A (zh) * 2011-03-01 2013-12-18 康诺特莱索瑟维斯有限公司 阀插入件
US20220265994A1 (en) * 2021-02-23 2022-08-25 Ventriflo, Inc. Pump-Valving Assembly for a Pulsatile Fluid Pump
CN116370818A (zh) * 2023-03-24 2023-07-04 上海化创医疗科技有限公司 心脏循环辅助装置及循环辅助系统

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120789471A (zh) * 2025-09-11 2025-10-17 脉柯斯医疗科技(绍兴)有限公司 双向阀和心室辅助介入装置
CN120789471B (en) * 2025-09-11 2025-12-16 脉柯斯医疗科技(绍兴)有限公司 Bi-directional valve and ventricular assist intervention device

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