Two-way valve and pulsation intervention type ventricular assist device

Abstract

The invention relates to the technical field of ventricular auxiliary devices, in particular to a two-way valve and a pulse intervention type ventricular auxiliary device adopting the two-way valve. The two-way valve comprises a valve body, an inner cavity with a near port and a far port is formed in the valve body in the axial direction in a penetrating mode, and a window communicated with the inner cavity and the exterior of the valve body is formed in the valve body; the valve clack is arranged at the window opening, and one end, close to the near port, of the valve clack is rotatably connected with the valve body, so that the valve clack can rotate back and forth between a closing position and an opening position; at the closing position, the valve clack closes the opening window, and the near port is communicated with the far port; at the opening position, the near port and the far port are separated by the valve clack, and the opening window is opened and is communicated with the far port; a flow choking structure is arranged on the inner side face, close to the inner cavity, of the valve clack, and the flow choking structure is used for enabling the valve clack to be rotationally switched between the closing position and the opening position under the impact of blood flow axially flowing in the inner cavity. Better switching response and sealing effects can be achieved, and better blood flow guiding capacity is achieved.

Description

Technical Field

[0001] 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. Background Art

[0002] Interventional ventricular assist device (pVAD) has the advantages of less trauma, fewer complications and easy operation. Through effective support of the circulatory system, it can correct the sudden hemodynamic disorder, improve tissue perfusion, and buy precious rescue time for patients. pVAD is a device for medium- and short-term use. Its indications are mainly for intraoperative support of high-risk PCI patients and rehabilitation treatment of patients with cardiogenic shock.

[0003] 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 aorta. The pump drives the blood flow to change its direction to extract and reinject blood, and the two-way valve cooperates with the reversal of blood flow direction to guide blood flow: when blood is extracted, the blood in the left ventricle flows into the pump through the interventional catheter and the two-way valve; when blood is reinjected, the blood in the pump flows into the interventional catheter, and the two-way valve is reversed at the two-way valve and ejected from the two-way valve to the aorta, thereby achieving blood circulation assistance.

[0004] Therefore, 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. Summary of the invention

[0005] In view of the above-mentioned defects in the prior art, the technical problem to be solved by the present invention is to provide a two-way valve with better switching response and sealing effect.

[0006] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0007] The present invention provides a two-way valve, comprising: a valve body, the interior of which is axially penetrated to form an inner cavity with a proximal port and a distal port, a window is provided on the valve body between the proximal port and the distal port, the window connects the inner cavity with the outside of the valve body; a valve flap, which is provided at the window, and one end of the valve flap close to the proximal port is rotatably connected to the valve body so that the valve flap can rotate back and forth between a closed position and an open position; in the closed position, the valve flap is located in the window and closes the window, and the proximal port is connected to the distal port; in the open position, the valve flap is located in the inner cavity and separates the proximal port from the distal port, and the window is opened and connected to the distal port; a flow-blocking structure is provided on the inner side surface of the valve flap close to the inner cavity, and the flow-blocking structure is used to rotate and switch the valve flap between the closed position and the open position under the impact of the blood flow axially flowing in the inner cavity.

[0008] Preferably, the valve body has a middle section, and a window is arranged in the middle section. The cross-sectional shape of the inner circumference contour of the middle section is circular, and the cross-sectional shape of the outer circumference contour of the middle section is rectangular. The valve flap is flat and is located outside the inner circumference contour of the middle section and parallel to the outer circumference contour of the middle section when the valve flap is in the closed position.

[0009] Preferably, the valve body has a middle section, the cross-sectional shape of the outer peripheral contour of the middle section is a rectangle, the cross-sectional shape of the inner peripheral contour of at least the middle part of the middle section is a rectangle, the window is arranged in the middle part of the middle section, the valve flap is a flat plate, and the valve flap is parallel to the middle section when in the closed position.

[0010] Preferably, the outer contour of the valve flap matches the outer contour of an oblique section of the inner circumferential contour of the valve body, and the inner contour of the window opening matches the outer contour of the valve flap.

[0011] Preferably, in the closed position, the valve flap is interference-fitted with an end of the window opening away from the inner cavity.

[0012] Preferably, a limiting portion is provided at one end of the window away from the inner cavity, and in the closed position, the outer side surface of the valve flap away from the inner cavity abuts against the limiting portion.

[0013] Preferably, the valve flap is rotatably connected to the valve body via a pin, and the axis of the pin is arranged perpendicular to the axial direction of the valve body.

[0014] Preferably, the valve flap rotates between the closed position and the open position to switch between an angle of 20°-60°.

[0015] Preferably, the flow-blocking structure is a flow-blocking plate arranged on the valve flap, and the two opposite side surfaces of the flow-blocking plate are respectively a first flow-blocking surface facing the proximal port and a second flow-blocking surface facing the distal port, and the second flow-blocking surface forms an acute angle with an end of the valve flap close to the distal port and has a smooth transition.

[0016] Preferably, the spoiler is a curved sheet structure, and the first spoiler surface and the second spoiler surface are both curved surfaces.

[0017] Preferably, one end of the valve flap close to the proximal port is bent and extended toward the inner cavity to form a leaf. In the open position, the valve flap and the leaf together separate the proximal port and the distal port.

[0018] The present invention also provides a pulsating interventional ventricular assist device, which uses the bidirectional valve as described above.

[0019] Compared with the prior art, the present invention has significant improvements:

[0020] The two-way valve of the present invention drives the valve flap to rotate by the blood flow impacting the flow-blocking structure arranged on the inner side 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 coordination with the change of blood flow direction, and can achieve timely and reliable switching response. 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 blood flow impact makes the valve flap remain in the closed position or the open position, so that a reliable and stable sealing effect can be achieved. Therefore, the two-way valve of the present invention can achieve better switching response and sealing effect, and has better blood flow guiding ability. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the valve body structure of the two-way valve according to the first embodiment of the present invention.

[0022] Figure 2 It is a schematic diagram of the valve flap and baffle structure of the two-way valve of the first embodiment of the present invention.

[0023] Figure 3 This is a top view schematic diagram of the two-way valve of Example 1 of the present invention when the valve disc is in the closed position.

[0024] Figure 4 yes Figure 3 Schematic cross-sectional view along AA direction.

[0025] Figure 5 This is a top view schematic diagram of the two-way valve of Example 1 of the present invention when the valve disc is in the open position.

[0026] Figure 6 yes Figure 5 Schematic cross-sectional view along the BB direction.

[0027] Figure 7 It is a schematic diagram of the valve body structure of the two-way valve of the second embodiment of the present invention.

[0028] Figure 8 This 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.

[0029] Fig. 9 This 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 open position.

[0030] Fig.10 This is a three-dimensional schematic diagram of the two-way valve of Example 3 of the present invention, when the valve disc is in the closed position.

[0031] Fig.11 This is a cross-sectional schematic diagram of the two-way valve of Example 3 of the present invention, when the valve disc is in the closed position.

[0032] Fig.12This is a three-dimensional schematic diagram of the two-way valve of Example 3 of the present invention, when the valve disc is in the open position.

[0033] Fig.13 This is a cross-sectional schematic diagram of the two-way valve of Example 3 of the present invention, when the valve disc is in the open position.

[0034] Fig.14 It is a schematic diagram of the valve flap and baffle structure of the two-way valve of the third embodiment of the present invention.

[0035] Fig.15 It is a schematic diagram of the structure of a pulsatile interventional ventricular assist device according to a fourth embodiment of the present invention.

[0036] The reference numerals are described as follows:

[0037] 1 Valve body

[0038] 10 Inner cavity

[0039] 10a Near port

[0040] 10b Far Port

[0041] 10c Open window

[0042] 11 middle section

[0043] 12 Near section

[0044] 13 Distal

[0045] 14 Limiting part

[0046] 2 Disc

[0047] 21 Inner side

[0048] 22 Outer side

[0049] 23 ears

[0050] 24 blades

[0051] 3 Flow blocking structure

[0052] 30 Spoiler

[0053] 30a First flow blocking surface

[0054] 30b Second blocking surface

[0055] 4 Pin

[0056] 100 Ventricular Catheter

[0057] 200 Two-way valve

[0058] 300 Peripheral Catheter

[0059] 400 Pumps

[0060] 500 Femoral artery

[0061] 600 Heart

[0062] 700 Aorta DETAILED DESCRIPTION

[0063] The specific embodiments of the present invention are further described in detail below in conjunction with the accompanying drawings. These embodiments are only used to illustrate the present invention, but not to limit the present invention.

[0064] In the description of the present invention, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0065] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, 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. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0066] Furthermore, in the description of the present invention, unless otherwise specified, “plurality” means two or more.

[0067] Embodiment 1

[0068] like Figures 1 to 6 The figure shows the first embodiment of the bidirectional valve provided by the present invention. The bidirectional valve of the first embodiment includes a valve body 1 and a valve flap 2 .

[0069] The valve body 1 is axially connected to form an inner cavity 10, and the inner cavity 10 has a proximal port 10a and a distal port 10b that are opposite and connected along the axial direction of the valve body 1. The valve body 1 is provided with an opening 10c between the proximal port 10a and the distal port 10b, and the opening 10c connects the inner cavity 10 of the valve body 1 with the outside of the valve body 1.

[0070] The valve flap 2 is disposed at the opening window 10c of the valve body 1, and one end of the valve flap 2 close to the proximal end 10a of the inner cavity 10 is rotatably connected to the valve body 1, so that the valve flap 2 can rotate back and forth between a closed position and an open position.

[0071] See also Figure 3 and Figure 4 In the closed position, the valve flap 2 is located in the window opening 10c and closes the window opening 10c, and the proximal port 10a and the distal port 10b are connected, so that the inner cavity 10 of the valve body 1 is conductive, and blood can flow axially through the valve body 1 from the inner cavity 10.

[0072] See also Figure 5 and Figure 6 In the open position, the valve flap 2 is located in the inner cavity 10 and separates the proximal port 10a and the distal port 10b, and the opening window 10c is opened and connected to the distal port 10b. At this time, the inner cavity 10 of the valve body 1 is not conductive, and the blood entering the valve body 1 from the distal port 10b can flow out from the opening window 10c.

[0073] The valve flap 2 has an inner side surface 21 and an outer side surface 22 opposite to each other, wherein the inner side surface 21 is close to the inner cavity 10 and the outer side surface 22 is far away from the inner cavity 10. A flow blocking structure 3 is provided on the inner side surface 21 of the valve flap 2 close to the inner cavity 10, and the flow blocking structure 3 is used to rotate and switch the valve flap 2 between the closed position and the open position under the impact of the axial blood flow in the inner cavity 10. Figure 4 When blood flows from the proximal port 10a of the inner cavity 10 to the distal port 10b, the blood flow impacts the flow-blocking structure 3 on the inner side 21 of the valve flap 2, exerting a force on the valve flap 2 to rotate toward the outside of the inner cavity 10, causing the valve flap 2 to rotate to a closed position and remain in the closed position, closing the window 10c. At this time, the two-way valve guides the blood flow from the proximal port 10a of the inner cavity 10 to the distal port 10b. Figure 6 When blood flows from the distal port 10b of the inner cavity 10 to the proximal port 10a, the blood flow impacts the flow-blocking structure 3 on the inner side 21 of the valve flap 2, giving the valve flap 2 a force to rotate toward the inner cavity 10, so that the valve flap 2 rotates to an open position and remains in the open position, isolating the proximal port 10a and the distal port 10b of the inner cavity 10, and the window 10c is opened. At this time, the two-way valve guides the blood flow from the distal port 10b of the inner cavity 10 to the window 10c.

[0074] Therefore, the two-way valve of the first embodiment of the present invention can drive the valve flap 2 to rotate by the blood flow impacting the flow blocking structure 3 provided on the inner side 21 of the valve flap 2 when the blood flow direction changes, so that the valve flap 2 can automatically rotate and switch between the closed position and the open position in accordance with the change of the blood flow direction, thereby achieving timely and reliable switching response. At the same time, the valve flap 2 can close the window 10c on the valve body 1 in the closed position and separate the proximal port 10a and the distal port 10b of the inner cavity 10 in the open position, and the valve flap 2 can be maintained in the closed position or the open position by the blood flow impact, thereby achieving a reliable and stable sealing effect. Therefore, the two-way valve of the first embodiment of the present invention can achieve better switching response and sealing effect, and has better blood flow guiding ability.

[0075] The two-way valve of the first embodiment can be used for an interventional ventricular assist device. When in use, the two-way valve is installed on an interventional catheter and placed in the aorta. The proximal port 10a 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 10b 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 10c on the valve body 1 faces the aorta. When the ventricular assist pump draws out blood, the blood in the left ventricle flows from the proximal port 10a of the inner cavity 10 of the valve body 1 to the distal port 10b, causing the valve flap 2 to rotate to and remain in the closed position, and the two-way valve guides the blood flow from the left ventricle through the proximal port 10a and the distal port 10b of the inner cavity 10 of the valve body 1 to flow into the ventricular assist pump; when the ventricular assist pump reinjects blood, the blood in the ventricular assist pump flows from the distal port 10b of the inner cavity 10 of the valve body 1 to the proximal port 10a, causing the valve flap 2 to rotate to and remain in the open position, and the two-way valve guides the blood flow from the ventricular assist pump through the distal port 10b of the inner cavity 10 of the valve body 1 and the window 10c of the valve body 1 to be ejected to the aorta, thereby achieving blood circulation assistance.

[0076] In the first embodiment, preferably, the valve body 1 has a middle section 11, and the opening window 10c is provided in the middle section 11. The cross-sectional shape of the inner peripheral contour of the middle section 11 is circular, that is, the cross-sectional shape of the cavity wall of the inner cavity 10 at the middle section 11 is circular, and the cross-sectional shape of the outer peripheral contour of the middle section 11 is rectangular, so that the middle section 11 of the valve body 1 is a hollow cylinder with a circular inner circle and a square outer circle. The valve flap 2 is in the shape of a flat plate, and is located outside the inner peripheral contour of the middle section 11 of the valve body 1 when in the closed position, and the valve flap 2 is parallel to the outer peripheral contour of the middle section 11, specifically, parallel to one surface of the rectangular outer peripheral contour of the middle section 11. Therefore, the valve flap 2 will not interfere with the axial channel of the inner cavity 10 of the valve body 1 in the closed position, and the axial channel of the inner cavity 10 can be fully conductive, thereby reducing the obstruction to blood flow.

[0077] In the first embodiment, preferably, the outer contour of the valve flap 2 is consistent with the outer contour of an oblique section of the inner circumferential contour of the valve body 1, so that the valve flap 2 is just obliquely fitted with the wall of the inner cavity 10 of the valve body 1 in the open position, so that the valve flap 2 and the inner cavity 10 of the valve body 1 are in circumferential fit, thereby blocking the axial channel inside the inner cavity 10, that is, isolating the proximal port 10a and the distal port 10b of the inner cavity 10, which can ensure the sealing effect and prevent blood from leaking to the proximal port 10a of the inner cavity 10 when the two-way valve guides blood flow from the distal port 10b of the inner cavity 10 to the open window 10c, which is beneficial to all the blood pushed out of the ventricular assist pump into the aorta when reinjecting blood, preventing blood from flowing back into the left ventricle and avoiding additional load on the heart. The inner contour of the window 10c of the valve body 1 matches the outer contour of the valve flap 2, so that the valve flap 2 fits against the window 10 of the valve body 1 in the closed position, and the valve flap 2 and the window 10 of the valve body 1 fit in contact along the circumferential direction, thereby closing the window 10, which can ensure the sealing effect and prevent blood from leaking from the window 10 when the two-way valve guides blood flow from the proximal port 10a of the inner cavity 10 to the distal port 10b, which is beneficial for all the blood in the left ventricle to flow into the ventricular assist pump when blood is drawn out, preventing blood from being ejected into the aorta.

[0078] In the first embodiment, the cross-sectional shape of the inner circumference of the middle section 11 of the valve body 1 is circular, so the outer contour of an oblique section of the inner circumference of the middle section 11 of the valve body 1 is roughly elliptical, and accordingly, the outer contour of the valve flap 2 and the inner contour of the window 10c of the valve body 1 are also elliptical.

[0079] In the first embodiment, preferably, the valve flap 2 does not extend beyond the outer contour of the valve body 1 in the closed position, that is, the outer side surface 22 of the valve flap 2 does not extend beyond the outer contour of the valve body 1, so as to avoid the valve flap 2 from damaging the inner wall of the blood vessel during the process of rotating to the closed position. Therefore, a limiting structure is provided in the window 10c of the valve body 1 to limit the rotation of the valve flap 2 toward the outside of the inner cavity 10, that is, to limit the closed position. In the first embodiment, preferably, in the closed position, the valve flap 2 has an interference fit with the end of the window 10c of the valve body 1 away from the inner cavity 10, so as to prevent the valve flap 2 from continuing to rotate toward the outside of the inner cavity 10 after rotating to the closed position, so that the valve flap 2 remains positioned with the valve body 1 in the closed position, and is located in the end of the window 10c of the valve body 1 away from the inner cavity 10, and does not extend beyond the outer contour of the valve body 1.

[0080] In the first embodiment, preferably, the valve flap 2 is rotatably connected to the valve body 1 via a pin 4, and the axis of the pin 4 is arranged perpendicular to the axial direction of the valve body 1. Preferably, a flap ear 23 is provided on the inner side surface 21 of the valve flap 2 at one end close to the proximal port 10a of the inner cavity 10 of the valve body 1, one end of the pin 4 is rotatably connected to the flap ear 23 of the valve flap 2, and the other end of the pin 4 is rotatably connected to the valve body 1. The pin 4 connects the valve flap 2 and the valve body 1 on the inner side of the inner side surface 21 of the valve flap 2, so that the outer side surface 22 of the valve flap 2 is a flat surface. On the one hand, it is beneficial for the outer side surface 22 of the valve flap 2 not to extend beyond the outer contour of the valve body 1 when the valve flap 2 is in the closed position. On the other hand, it is also beneficial for the outer side surface 22 of the valve flap 2 to guide the blood flow from the distal port 10b of the inner cavity 10 to the open window 10c when the valve flap 2 is in the open position, and will not cause obstruction to the blood flow. In order to ensure the stability of the connection and rotation, preferably, refer to Figure 2 On the inner side surface 21 of the valve disc 2 at one end close to the proximal port 10a of the inner cavity 10 of the valve body 1, two flap ears 23 are provided at intervals along the axial direction of the pin shaft 4. The two flap ears 23 are rotatably connected to the valve body 1 through a pin shaft 4 respectively.

[0081] In the first embodiment, preferably, one end of the valve flap 2 close to the proximal end portion 10a of the inner cavity 10 of the valve body 1 is a smooth end portion. During the rotation of the valve flap 2 around the pin shaft 4, the smooth end portion of the valve flap 2 close to the proximal end portion 10a of the inner cavity 10 of the valve body 1 and the side of the opening window 10c close to the proximal end portion 10a of the inner cavity 10 of the valve body 1 remain roughly closed.

[0082] In this embodiment 1, see Figure 6 , the rotation angle of the valve flap 2 between the closed position and the open position is α, and the value of α is preferably 20°-60°. In the first embodiment, the valve flap 2 is parallel to a surface of the rectangular outer peripheral contour of the middle section 11 of the valve body 1 when in the closed position, and rotates to the inner cavity 10 of the valve body 1 at an angle α to reach the open position. The inclination angle of the valve flap 2 relative to the cavity wall of the inner cavity 10 of the valve body 1 when in the open position is α, and the angle α is 20°-60°, which is conducive to the valve flap 2 in the open position to smoothly pass the outer side surface 22 of the valve flap 2 and spray from the window 10c of the valve body 1 to the aorta, thereby ensuring the flow of blood in the channel from the distal port 10b of the inner cavity 10 of the valve body 1 to the window 10c.

[0083] In this embodiment 1, see Figure 2 , Figure 4 and Figure 6Preferably, the flow-blocking structure 3 is a flow-blocking plate 30 arranged on the valve disc 2, and the flow-blocking plate 30 has two opposite and parallel side surfaces, namely a first flow-blocking surface 30a facing the proximal port 10a of the inner cavity 10 of the valve body 1 and a second flow-blocking surface 30b facing the distal port 10b of the inner cavity 10 of the valve body 1, and the second flow-blocking surface 30b and an end portion of the valve disc 2 close to the distal port 10b of the inner cavity 10 of the valve body 1 form an acute angle and a smooth transition, and the first flow-blocking surface 30a and an end portion of the valve disc 2 close to the proximal port 10a of the inner cavity 10 of the valve body 1 form an obtuse angle and a smooth transition. When blood flows from the proximal port 10a of the inner cavity 10 of the valve body 1 to the distal port 10b, the blood flow impacts the first blocking surface 30a of the blocking plate 30, driving the valve flap 2 to rotate to the outside of the inner cavity 10 to a closed position. The first blocking surface 30a and an end of the valve flap 2 close to the proximal port 10a of the inner cavity 10 of the valve body 1 form an obtuse angle, which is beneficial for the valve flap 2 to guide the blood flow from the proximal port 10a of the inner cavity 10 of the valve body 1 to the distal port 10b when the valve flap 2 is in the closed position, and will not cause significant obstruction to the blood flow. When blood flows from the distal port 10b of the inner cavity 10 of the valve body 1 to the proximal port 10a, the blood flow impacts the second blocking surface 30b of the blocking plate 30, driving the valve flap 2 to rotate to the inner cavity 10 to the open position. The second blocking surface 30b and the end of the valve flap 2 close to the distal port 10b of the inner cavity 10 of the valve body 1 form an acute angle, which is conducive to forming an effective blocking area between the second blocking surface 30b and the valve flap 2, ensuring that the impact of the blood flow flowing into the blocking area can cause the valve flap 2 to rotate to the inner cavity 10 of the valve body 1. When the valve flap 2 starts to rotate from the closed position to the inner cavity 10 of the valve body 1, the outer side surface 22 of the valve flap 2 will gradually intervene in the blood flow and also play a blocking role. The impact of the blood flow on the outer side surface 22 of the valve flap 2 will further drive the valve flap 2 to rotate faster, so that the valve flap 2 quickly switches to the open position. The first blocking surface 30a and the second blocking surface 30b of the blocking plate 30 have a smooth transition with the valve flap 2, especially the second blocking surface 30b has a smooth transition with the acute angle area of ​​the valve flap 2, which can make the blood flow relatively smooth each time and avoid the formation of blood clots in a small space.

[0084] Preferably, the baffle 30 is a curved sheet structure, and both the first baffle surface 30a and the second baffle surface 30b are curved surfaces, which are more conducive to the opening and closing of the valve flap 2 and reduce the turbulence of blood flow.

[0085] See also Figure 3 and Figure 4In the bidirectional valve of the first embodiment, the two ends of the middle section 11 of the valve body 1 are respectively provided with a proximal section 12 and a distal section 13, and the proximal section 12, the middle section 11 and the distal section 13 are integrally formed as one piece. The proximal section 12 and the distal section 13 are respectively used to connect the interventional catheter. The inner and outer contours of the proximal section 12 and the distal section 13 are both circular, so as to facilitate assembly with the interventional catheter. The outer contour of the middle section 11 protrudes from the outer contour of the near section 12 and the outer contour of the far section 13, so as to form a step between the near section 12 and the far section 13. The diameters of the outer contours of the near section 12 and the far section 13 are consistent, both are D, and have a minimum height difference H with the outer contour of the middle section 11. The diameter D is adapted to the inner diameter of the interventional catheter, preferably 10Fr-24Fr, and the value of H is preferably 0.015D-0.25D, which can facilitate the valve body 1 to be bonded to the interventional catheter through the near section 12 and the far section 13. The inner contours of the near section 12, the middle section 11 and the far section 13 have the same diameter and together constitute the wall of the inner cavity 10 of the valve body 1. The diameter of the inner cavity 10 of the valve body 1 is preferably 0.7D-1D. The axial extension lengths of the near section 12 and the far section 13 are consistent, both are N, and the length N is preferably 0.5D-2D. The total axial extension length of the valve body 1 is O, and the length O is preferably 2D-4D. The total length O of the valve body 1 is not too long, so that the interventional ventricular assist device using the two-way valve can pass through the aortic arch smoothly, and at the same time, it can ensure that the valve flap 2 is easy to assemble. The size of the window 10c of the valve body 1 determines the blood flow discharged each time. The maximum caliber of the window 10c of the valve body 1 is L, and L is preferably 1D-2D. The extension length of the baffle 30 is M, and M is preferably 0.2D-0.7D, which is conducive to the opening and closing of the valve flap 2 and reduces the turbulence of blood flow. Of course, the above-mentioned dimensional parameters of the two-way valve of the first embodiment are not limited, and can be further adjusted and optimized according to actual usage.

[0086] Embodiment 2

[0087] like Figure 7 , Figure 8 and Fig. 9 As shown, it is the second embodiment of the two-way valve provided by the present invention. Embodiment 2 is basically the same as Embodiment 1, and the similarities are not repeated here. The difference is that in this embodiment 2, the limiting structure for limiting the rotation of the valve flap 2 toward the outside of the inner cavity 10 provided in the window opening 10c of the valve body 1 is different from that in Embodiment 1. In this embodiment 2, preferably, a limiting portion 14 is provided at the end of the window opening 10c of the valve body 1 away from the inner cavity 10, and in the closed position, the outer side surface 22 of the valve flap 2 away from the inner cavity 10 abuts against the limiting portion 14. In this way, the valve flap 2 is prevented from continuing to rotate toward the outside of the inner cavity 10 after rotating to the closed position, so that the valve flap 2 remains positioned with the valve body 1 in the closed position, and is located on the inner side of the end of the window opening 10c of the valve body 1 away from the inner cavity 10, and does not exceed the outer contour of the valve body 1.

[0088] Preferably, in the second embodiment, the limiting portion 14 is flush with the outer contour of the middle section 11 of the valve body 1. The limiting portion 14 is preferably arranged at one end of the opening window 10c of the valve body 1 close to the distal end 10b of the inner cavity 10 of the valve body 1.

[0089] Embodiment 3

[0090] like Figures 10 to 14 As shown, it is the third embodiment of the two-way valve provided by the present invention. The third embodiment is basically the same as the second embodiment, and the similarities are not repeated here. The difference is that in the third embodiment, the cross-sectional shape of the outer peripheral contour of the middle section 11 of the valve body 1 is rectangular, and the cross-sectional shape of the inner peripheral contour of at least the middle section 11 is rectangular, that is, the cross-sectional shape of the cavity wall of the inner cavity 10 at least in the middle section 11 is rectangular, so that at least the middle section 11 of the valve body 1 is a hollow cylinder with both the inner and outer sides being rectangular. The valve flap 2 is in the shape of a flat plate, and the valve flap 2 is parallel to the middle section 11 when in the closed position. Preferably, when the valve flap 2 is in the closed position, the outer side surface 22 of the valve flap 2 is flush with one surface of the rectangular outer peripheral contour of the middle section 11 of the valve body 1, and the inner side surface 21 of the valve flap 2 is flush with one surface of the rectangular inner peripheral contour of the middle section 11 of the valve body 1. As a result, the valve flap 2 will not interfere with the axial channel of the inner cavity 10 of the valve body 1 in the closed position, and the axial channel of the inner cavity 10 can be fully conductive, thereby reducing the obstruction to blood flow. At least the middle portion of the middle section 11 of the valve body 1 is in the shape of a hollow cylinder with both the inner and outer sides being rectangular, which is beneficial to increasing the blood jet flow rate sprayed into the aorta when the valve flap 2 is in the open position.

[0091] In the third embodiment, the cross-sectional shape of the inner circumferential contour of the middle part of the middle section 11 of the valve body 1 is rectangular, and the cross-sectional shape of the inner circumferential contour of the two end parts of the middle section 11 close to the proximal section 12 and the distal section 13 of the valve body 1 can be circular. The diameter of the circular inner circumferential contour of the two end parts of the middle section 11 is consistent with the diameter of the inner circumferential contour of the proximal section 12 and the distal section 13 of the valve body 1, and is smaller than the minimum inner diameter of the rectangular inner circumferential contour of the middle part of the middle section 11. The inner circumferential contours of the proximal section 12, one end of the middle section 11, the middle of the middle section 11, the other end of the middle section 11 and the distal section 13 together constitute the cavity wall of the inner cavity 10 of the valve body 1.

[0092] In the third embodiment, the cross-sectional shape of the inner circumferential contour of the middle portion of the middle section 11 of the valve body 1 is a rectangle, so the outer contour of an oblique section of the inner circumferential contour of the middle portion of the middle section 11 of the valve body 1 is roughly rectangular, and accordingly, the outer contour of the valve flap 2 and the inner contour of the window 10c of the valve body 1 are also rectangular.

[0093] In the third embodiment, preferably, the end of the valve flap 2 close to the proximal port 10a of the inner cavity 10 of the valve body 1 is bent and extended toward the inner cavity 10 of the valve body 1 with a blade 24. In the closed position, the valve flap 2 is located in the window opening 10c and closes the window opening 10c, and the blade 24 is located in the inner cavity 10 of the valve body 1. In the open position, the blade 24 is located on one side of the window opening 10c close to the proximal port 10a of the inner cavity 10 of the valve body 1, the valve flap 2 is located in the inner cavity 10 of the valve body 1, and the valve flap 2 and the blade 24 together separate the proximal port 10a and the distal port 10b of the inner cavity 10. In the third embodiment of the present invention, in the open position, the outer contour of the blade 24 is tangent to the wall of the inner cavity 10 at the upper part of the inner cavity 10 near the opening window 10c and closes the end of the opening window 10c near the proximal port 10a of the inner cavity 10, and the valve flap 2 is beveled and fitted to the wall of the inner cavity 10 of the valve body 1, thereby achieving the valve flap 2 and the blade 24 jointly isolating the proximal port 1a and the distal port 1b of the inner cavity 10, which can ensure the sealing effect and prevent blood from flowing back into the left ventricle.

[0094] In the third embodiment, preferably, a limiting portion 14 is provided at one end of the window opening 10c of the valve body 1 away from the inner cavity 10, and the limiting portion 14 is provided at one end of the window opening 10c of the valve body 1 close to the distal port 10b of the inner cavity 10 of the valve body 1, and the side of the limiting portion 14 facing the inner cavity 10 is an inclined surface, and the end of the outer side surface 22 of the valve flap 2 close to the distal port 10b of the inner cavity 10 of the valve body 1 is an inclined surface inclined toward the inner side surface 21 of the valve flap 2. In the closed position, the inclined surface of the end of the outer side surface 22 of the valve flap 2 close to the distal port 10b of the inner cavity 10 abuts against the inclined surface of the limiting portion 14 facing the inner cavity 10, thereby preventing the valve flap 2 from continuing to rotate to the outside of the inner cavity 10 after rotating to the closed position, so that the valve flap 2 remains positioned with the valve body 1 in the closed position, and is located in the window opening 10c of the valve body 1, and does not exceed the outer contour of the valve body 1.

[0095] Embodiment 4

[0096] like Fig.15 As shown, an embodiment of the pulsatile interventional ventricular assist device provided by the present invention is provided. The pulsatile interventional ventricular assist device of this embodiment 4 is proposed based on the two-way valve of the present invention, and any one of the two-way valves described in the above-mentioned embodiments 1 to 3 can be adopted. Since the two-way valve can achieve better switching response and sealing effect and has better blood flow guiding ability, the working ability and operation effect of the pulsatile interventional ventricular assist device of this embodiment 4 are effectively improved and optimized.

[0097] Specifically, the pulsatile interventional ventricular assist device of the fourth embodiment includes a ventricular catheter 100, a two-way valve 200, a peripheral catheter 300, a pump 400, and an external control device (not shown in the figure) that controls the pump 400 to extract and reinject blood, which are connected in sequence. The two-way valve 200 adopts the two-way valve of the present invention, and can be any one of the two-way valves described in the above-mentioned embodiments one to three. 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 10a 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 10b 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.

[0098] The working principle of the pulsating interventional ventricular assist device of the fourth embodiment is that the external control device provides a set pulse to the pump 400, so that the pump 400 changes the direction of blood flow during the process of extracting and reinjecting blood. The pulsation set by the external control device and the heart 600 synchronously "push and pull" the pump 400 to achieve blood extraction and reinjection. During the myocardial contraction period, the blood flows into the two-way valve 200 through the tip of the ventricular catheter 100 located in the left ventricle, and the blood flows from the proximal port 10a of the inner cavity 10 of the valve body 1 to the distal port 10b. The blood impacts the first blocking surface 30a of the blocking plate 30 on the valve flap 2, driving the valve flap 2 to rotate around the pin shaft 4 to the outside of the inner cavity 10 of the valve body 1 to the closed position, closing the window 10c of the valve body 1, and the blood flows from the proximal port 10a of the inner cavity 10 of the valve body 1 to the distal port 10b, and is sucked into the pump 400 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. When the blood just enters the distal port 10b of the inner cavity 10 of the valve body 1, the valve flap 2 is still in the closed position. When the blood flows reversely into the inner cavity 10 of the valve body 1, it impacts the second blocking surface 30b of the blocking plate 30 on the valve flap 2. The valve flap 2 will rotate around the pin shaft 4 to the inside of the inner cavity 10 of the valve body 1 to the open position under the impact of the blood flow. At this time, when the myocardium is in diastole, the blood will be ejected laterally from the open window 10c of the valve body 1 to the aorta 700, completing a cycle.

[0099] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and substitutions can be made without departing from the technical principles of the present invention. These improvements and substitutions should also be regarded as the scope of protection of the present invention.

Claims

1. A two-way valve, It is characterized in that include: A valve body (1) having an inner cavity (10) which is axially penetrated to form a proximal port (10a) and a distal port (10b); a window (10c) is provided on the valve body (1) between the proximal port (10a) and the distal port (10b); the window (10c) communicates the inner cavity (10) with the outside of the valve body (1); A valve flap (2) is arranged at the opening window (10c), and one end of the valve flap (2) close to the proximal port (10a) is rotatably connected to the valve body (1), so that the valve flap (2) can rotate back and forth between a closed position and an open position; In the closed position, the valve flap (2) is located in the window opening (10c) and closes the window opening (10c), and the proximal port (10a) and the distal port (10b) are connected; In the open position, the valve flap (2) is located in the inner cavity (10) and separates the proximal port (10a) from the distal port (10b), and the opening window (10c) is opened and communicated with the distal port (10b); A flow-blocking structure (3) is provided on the inner side surface (21) of the valve flap (2) close to the inner cavity (10), and the flow-blocking structure (3) is used to be impacted by the blood flow flowing axially in the inner cavity (10) so as to cause the valve flap (2) to rotate and switch between the closed position and the open position.

2. The two-way valve according to claim 1, It is characterized in that The valve body (1) has a middle section (11), the opening window (10c) is arranged in the middle section (11), the cross-sectional shape of the inner peripheral contour of the middle section (11) is circular, and the cross-sectional shape of the outer peripheral contour of the middle section (11) is rectangular, and the valve flap (2) is flat, and the valve flap (2) is located outside the inner peripheral contour of the middle section (11) and parallel to the outer peripheral contour of the middle section (11) when in the closed position.

3. The two-way valve according to claim 1, It is characterized in that The valve body (1) has a middle section (11), the cross-sectional shape of the outer peripheral contour of the middle section (11) is rectangular, the cross-sectional shape of the inner peripheral contour of at least the middle portion of the middle section (11) is rectangular, the opening window (10c) is arranged in the middle of the middle section (11), the valve flap (2) is flat, and the valve flap (2) is parallel to the middle section (11) when in the closed position.

4. The two-way valve according to any one of claims 1 to 3, It is characterized in that The outer contour of the valve flap (2) matches the outer contour of an oblique cut surface of the inner peripheral contour of the valve body (1), and the inner contour of the opening window (10c) matches the outer contour of the valve flap (2).

5. The two-way valve according to any one of claims 1 to 3, It is characterized in that In the closed position, the valve flap (2) is interference-fitted with an end of the opening window (10c) away from the inner cavity (10).

6. The two-way valve according to any one of claims 1 to 3, It is characterized in that A limiting portion (14) is provided at one end of the opening window (10c) away from the inner cavity (10); in the closed position, an outer side surface (22) of the valve flap (2) away from the inner cavity (10) abuts against the limiting portion (14).

7. The two-way valve according to claim 1, It is characterized in that The valve flap (2) is rotatably connected to the valve body (1) via a pin shaft (4), and the axis of the pin shaft (4) is arranged perpendicular to the axial direction of the valve body (1).

8. The two-way valve according to claim 1, It is characterized in that The valve flap (2) has a rotation angle of 20°-60° for switching between the closed position and the open position.

9. The two-way valve according to claim 1, It is characterized in that The flow blocking structure (3) is a flow blocking plate (30) arranged on the valve flap (2), and the two opposite side surfaces of the flow blocking plate (30) are respectively a first flow blocking surface (30a) facing the proximal port (10a) and a second flow blocking surface (30b) facing the distal port (10b), and the second flow blocking surface (30b) forms an acute angle with an end of the valve flap (2) close to the distal port (10b) and has a smooth transition.

10. The two-way valve according to claim 9, It is characterized in that The flow-blocking sheet (30) is a curved sheet-like structure, and the first flow-blocking surface (30a) and the second flow-blocking surface (30b) are both curved surfaces.

11. The two-way valve according to claim 1, It is characterized in that One end of the valve flap (2) close to the proximal port (10a) is bent and extended toward the inner cavity (10) to form a leaf (24); in the open position, the valve flap (2) and the leaf (24) jointly separate the proximal port (10a) and the distal port (10b).

12. A pulsatile interventional ventricular assist device, It is characterized in that A two-way valve as claimed in any one of claims 1 to 11 is used.

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