Stent for left ventricular outflow tract and delivery system

Abstract

The application relates to a left ventricular outflow tract stent and a delivery system, wherein the left ventricular outflow tract stent comprises a plurality of connecting beams, the connecting beams abut against the inner wall of the left ventricular outflow tract in a propped state, and at least part of the connecting beams abut against the failed leaflet of the native mitral valve. In the propped state of the left ventricular outflow tract stent, the connecting beams close to the mitral valve side can abut against the native leaflet, so that the native leaflet can be squeezed between the interventional mitral valve prosthesis and the left ventricular outflow tract stent provided in the embodiment; when the left ventricle is in the systolic phase, the native leaflet can be limited by the interventional mitral valve prosthesis and the left ventricular outflow tract stent provided in the embodiment and cannot swing with the blood flow at will, so that the native leaflet can effectively avoid shielding the left ventricular outflow tract, and blood can normally flow from the left ventricle to the aorta.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a left ventricular outflow tract stent and a delivery system. BACKGROUND

[0002] After the implantation of the mitral valve interventional valve, the interventional valve squeezes the left ventricular outflow tract, making the left ventricular outflow tract narrow; at the same time, due to the blockage of the interventional valve frame, the native mitral valve leaflet cannot rotate towards the mitral valve direction during the left ventricular systole, and under the impact of the blood flow, it will rotate towards the aortic side, further blocking the left ventricular outflow tract, thereby causing blood flow obstruction. SUMMARY

[0003] The purpose of the present application is to provide a left ventricular outflow tract stent and a delivery system to solve the problem of blood flow obstruction caused by the narrowing of the left ventricular outflow tract due to the implantation of the mitral valve interventional valve in the prior art.

[0004] The first aspect of the present application provides a left ventricular outflow tract stent, which comprises a plurality of connecting beams, wherein in the expanded state, the connecting beams abut against the inner wall of the left ventricular outflow tract, and at least part of the connecting beams abut against the failed leaflet of the native mitral valve, so as to avoid the failed native leaflet blocking the left ventricular outflow tract, and keep the left ventricular outflow tract in a passable state at all times.

[0005] In a possible design, the connecting beams have at least one barb, and in the expanded state, the left ventricular outflow tract stent is anchored to the inner wall of the left ventricular outflow tract by part of the barbs, and is anchored to the failed native leaflet or the native mitral valve or the interventional mitral valve prosthesis by the other part of the barbs or passes through the failed native leaflet.

[0006] In a possible design, a plurality of mesh holes are formed between the plurality of connecting beams, so that the diameter of the left ventricular outflow tract stent is D1.

[0007] In the collapsed state, the plurality of connecting beams are in contact with each other, so that the diameter of the left ventricular outflow tract stent is D2, and D2

[0008] In a possible design, in the expanded state, the connecting beams are arc-shaped and arch upward away from the axis of the left ventricular outflow tract stent.

[0009] In a possible design, the left ventricular outflow tract stent comprises a first part and a second part, and in the expanded state, a recess structure is formed at the connection position of the first part and the second part.

[0010] In a possible design, the material of the connecting beams is a nickel-titanium memory alloy material or a cobalt-chromium alloy material, and the left ventricular outflow tract stent is anchored to the inner wall of the left ventricular outflow tract by self-expansion force.

[0011] In a possible design, the material of the connecting beams is stainless steel material or non-metal material, and the left ventricular outflow tract stent is anchored to the inner wall of the left ventricular outflow tract by expansion force of a balloon of a delivery system.

[0012] In a possible design, the inflow end of the left ventricular outflow tract stent is provided with a receiving claw.

[0013] In a possible design, the mesh holes are diamond-shaped holes.

[0014] The second aspect of the present application further provides a delivery system, wherein the delivery system is used to deliver the left ventricular outflow tract stent provided in the first aspect of the present application.

[0015] The technical solutions provided in the present application can achieve the following beneficial effects:

[0016] The left ventricular outflow tract stent and the delivery system provided in the present application can achieve the following beneficial effects: when the left ventricular outflow tract stent is in the expanded state, the connecting beams close to the side of the mitral valve can abut on the native leaflet, so that the native leaflet can be squeezed between the interventional mitral valve prosthesis and the left ventricular outflow tract stent provided in the present embodiment; when the left ventricle is in the systolic phase, the native leaflet can be limited by the interventional mitral valve prosthesis and the left ventricular outflow tract stent provided in the present embodiment and cannot swing with the blood flow at will, so that the native leaflet can effectively avoid shielding the left ventricular outflow tract, and the blood can normally flow from the left ventricle to the aorta.

[0017] It should be understood that the foregoing general description and the following detailed description are only exemplary and cannot limit the present application. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 A schematic diagram of a part of a human heart;

[0019] Figure 2 A state diagram after implantation of an interventional mitral valve prosthesis;

[0020] Figure 3 A structural schematic diagram of the left ventricular outflow tract stent provided in the embodiment of the present application (I);

[0021] Figure 4 A state diagram after implantation of the left ventricular outflow tract stent and the interventional mitral valve prosthesis provided in the embodiment of the present application;

[0022] Figure 5Structure schematic view of left ventricular outflow tract stent (two) provided by the embodiments of the present application.

[0023] Reference signs:

[0024] 100 - heart;

[0025] 110 - left atrium;

[0026] 120 - left ventricle;

[0027] 121 - left ventricular outflow tract;

[0028] 130 - mitral valve;

[0029] 131 - native leaflet;

[0030] 140 - aortic valve;

[0031] 200 - interventional mitral valve prosthesis;

[0032] 300 - left ventricular outflow tract stent;

[0033] 310 - first part;

[0034] 320 - second part;

[0035] 330 - concave structure;

[0036] 340 - connecting beam;

[0037] 350 - income claw;

[0038] 360 - inflow end;

[0039] 370 - mesh;

[0040] 380 - barb.

[0041] The drawings herein are incorporated into the specification and form a part of the specification, showing embodiments consistent with the present application, and together with the specification, serve to explain the principles of the present application. DETAILED DESCRIPTION

[0042] In order to better understand the technical solutions of the present application, the embodiments of the present application will be described in detail below in combination with the drawings.

[0043] It should be clear that the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor belong to the scope of protection of the present application.

[0044] The terminology used in the embodiments of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. As used in the description of the embodiments of the present application and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0045] It should be understood that the term "and / or" used herein is only a description of the association relationship of the associated objects, which means that there can be three relationships, for example, A and / or B can represent: A exists alone, A and B exist together, and B exists alone. In addition, the character " / " herein generally represents that the front and rear associated objects are in an "or" relationship.

[0046] It should be noted that the "up", "down", "left", "right" and other orientation words described in the embodiments of the present application are described from the angle shown in the drawings, and should not be understood as a limitation of the embodiments of the present application. In addition, in the context, it should also be understood that when referring to an element connected to another element "on" or "under", it can be directly connected to another element "on" or "under" or indirectly connected to another element "on" or "under" through an intermediate element.

[0047] The human heart 100 includes four chambers, a left atrium 110, a left ventricle 120, a right atrium, and a right ventricle. Among them, when the left atrium 110 is diastolic, blood can be guided back to the left atrium 110; when the left atrium 110 is systolic, blood enters the left ventricle 120; when the left ventricle 120 is systolic, blood can be pumped into the aorta through the left ventricular outflow tract 121. Among them, there is a mitral valve 130 between the left atrium 110 and the left ventricle 120, and there is an aortic valve 140 between the left ventricular outflow tract 121 and the aorta. The mitral valve 130 and the aortic valve 140 can prevent blood from flowing, and play an important role in ensuring that the heart 100 performs normal blood circulation.

[0048] Among them, the mitral valve 130 is the main part of the heart 100 lesion, when the mitral valve 130 lesion fails, such as the native leaflet 131 cannot be effectively closed, causing blood to partially converge, at this time, an interventional mitral valve prosthesis 200 is generally used to replace the native mitral valve. The interventional mitral valve prosthesis 200 is implanted into the position of the native mitral valve through a dedicated delivery system, and the native leaflet 131 will not be removed, but will be blocked outside the interventional mitral valve prosthesis 200 after the interventional mitral valve prosthesis 200 is expanded, so that the native leaflet 131 is in a "free" state. At this time, the native leaflet 131 will be impacted by the blood flow and will freely sway with the blood flow.

[0049] During the systole of the left ventricle 120, the left ventricular outflow tract 121 is narrowed, and due to the support of the interventional mitral valve prosthesis 200, the native valve leaflet 131 cannot turn towards the mitral valve 130, and the native valve leaflet 131 will be impacted by the blood flow and turn towards the aortic valve 140, which will block the left ventricular outflow tract 121 and cause the left ventricular outflow tract 121 to be further narrowed. Thus, it is easy to cause blood flow obstruction and cannot pump enough blood flow into the aorta.

[0050] The present application provides a left ventricular outflow tract stent 300, which comprises a plurality of connecting beams 340. In the expanded state, the connecting beams 340 abut against the inner wall of the left ventricular outflow tract 121, and at least part of the connecting beams 340 abut against the failed native valve leaflet 131 of the native mitral valve 130, so as to avoid the obstruction of the failed native valve leaflet to the left ventricular outflow tract, and keep the left ventricular outflow tract in a passable state at all times.

[0051] In the expanded state of the left ventricular outflow tract stent 300, the connecting beams 340 near the mitral valve side can abut against the failed native valve leaflet 131, so that the native valve leaflet 131 can be squeezed between the interventional mitral valve prosthesis 200 and the left ventricular outflow tract stent 300 provided in the embodiment. When the left ventricle 120 is in the systole, the native valve leaflet 131 can be limited by the interventional mitral valve prosthesis 200 and the left ventricular outflow tract stent 300 provided in the embodiment, and will not randomly sway with the blood flow, so as to effectively avoid the obstruction of the native valve leaflet 131 to the left ventricular outflow tract 121, and ensure the normal blood flow from the left ventricle 120 to the aorta.

[0052] Specifically, as Figure 5As shown, the connecting beams 340 have at least one barb 380. When the left ventricular outflow tract stent 300 is in the expanded state, the left ventricular outflow tract stent 300 is anchored to the inner wall of the left ventricular outflow tract 121 by part of the barbs 380, and is anchored to the failed native leaflet 131 or the native mitral valve or the interventional mitral valve prosthesis 200 by the other part of the barbs 380. When the left ventricular outflow tract stent 300 is implanted and expanded, part of the connecting beams 340 can abut against the inner wall tissue of the left ventricular outflow tract 121, and the barbs 380 can be hooked on the inner wall tissue of the left ventricular outflow tract 121 to prevent the left ventricular outflow tract stent 300 from moving or rotating, thereby ensuring the reliability of the anchoring. Meanwhile, the barbs 380 on the left ventricular outflow tract stent 300 towards the side of the mitral valve can be anchored to the failed native leaflet 131, or the barbs 380 can penetrate the failed native leaflet 131 and be anchored to the native mitral valve or the interventional mitral valve prosthesis 200, thereby limiting the shaking of the failed native leaflet 131 and avoiding blocking the left ventricular outflow tract 121 through the anchoring effect of the barbs 380.

[0053] Specifically, a plurality of mesh holes 370 are formed between the plurality of connecting beams 340, so that the diameter of the left ventricular outflow tract stent 300 is D1. When the left ventricular outflow tract stent 300 is in the collapsed state, the plurality of connecting beams 340 are in contact with each other, so that the diameter of the left ventricular outflow tract stent 300 is D2, and D2

[0054] Specifically, when the left ventricular outflow tract stent 300 is in the collapsed state, the plurality of connecting beams 340 are in contact with each other through their deformation, so that the left ventricular outflow tract stent 300 becomes a small-diameter tubular shape with a diameter D2, thereby being placed in the delivery system. Through the delivery system, the left ventricular outflow tract stent 300 can be delivered to the left ventricular outflow tract 121. At the implantation site, the left ventricular outflow tract stent 300 in the collapsed state can be automatically expanded after being released from the delivery system, or be expanded by the balloon of the delivery system. The left ventricular outflow tract stent 300 in the expanded state has a larger diameter D1, and can be anchored to the inner wall of the left ventricular outflow tract 121, thereby completing the implantation operation.

[0055] In addition, by forming the plurality of mesh holes 370 and the plurality of elastic connecting beams 340 on the left ventricular outflow tract stent 300, the left ventricular outflow tract stent 300 can deform correspondingly with the contraction or expansion of the left ventricle 120, ensuring the normal movement of the left ventricle 120 tissue. In order to facilitate the deformation of the left ventricular outflow tract stent 300, the mesh hole 370 can be a diamond hole.

[0056] Specifically, in the expanded state, the connecting beam 340 is arc-shaped, and the connecting beam 340 arches away from the axis of the left ventricular outflow tract stent 300.

[0057] In the expanded state, the connecting beam 340 needs to abut against the inner wall of the left ventricular outflow tract 121. Since the tissue of the inner wall of the left ventricular outflow tract 121 is relatively soft, the arc-shaped connecting beam 340 can extrude the tissue of the inner wall of the left ventricular outflow tract 121, so that the extruded tissue forms the same shape as the arc-shaped connecting beam 340. At this time, the extruded tissue can completely adhere to the surface of the connecting beam 340, which can increase the contact area between the connecting beam 340 and the tissue on one hand, and on the other hand, the arc-shaped connecting surface can generate extrusion force in all directions in the axial direction of the left ventricular outflow tract stent 300, preventing the left ventricular outflow tract stent 300 from moving axially, and ensuring the stability of the implantation position of the left ventricular outflow tract stent 300.

[0058] Specifically, the left ventricular outflow tract stent 300 includes a first portion 310 and a second portion 320. In the expanded state, the first portion 310 and the second portion 320 form a concave structure 330 at the connection position.

[0059] In the expanded state, the connecting beams 340 of the first part 310 and the second part 320 are both arc-shaped and arch upward away from the axis of the left ventricular outflow tract stent 300, so that two wave crests are formed on the outside of the left ventricular outflow tract stent 300 and in the axial direction, which can abut against the inner wall tissue of the left ventricular outflow tract 121 to achieve anchoring and axial limiting. The concave structure 330 is formed between the two wave crests, so that when the two wave crests press the inner wall tissue of the left ventricular outflow tract 121, part of the inner wall tissue of the left ventricular outflow tract 121 can also be trapped in the concave structure 330 and abut against the surface of the concave structure 330, thereby increasing the contact area between the left ventricular outflow tract stent 300 and the inner wall of the left ventricular outflow tract 121, and further achieving axial limiting to ensure the reliability of the anchoring of the left ventricular outflow tract stent 300. In addition, it should be noted that the concave structure 330 near the native valve leaflet 131 side can accommodate the native valve leaflet 131 at the position of the concave structure 330, avoiding the impact of blood on the native valve leaflet 131, thereby reducing the obstruction of the native valve leaflet 131 to the blood flow, ensuring the unobstructed flow of the blood flow, and avoiding the swing of the native valve leaflet 131 caused by the impact of the blood flow, thereby shielding the inflow end 360 of the left ventricular outflow tract stent 300.

[0060] Specifically, in an embodiment, the material of the connecting beam 340 can be a nickel-titanium memory alloy material or a cobalt-chromium alloy material, which has good elasticity and can anchor the left ventricular outflow tract stent 300 to the inner wall of the left ventricular outflow tract 121 through its own expansion force after the delivery system is released.

[0061] In another embodiment, the material of the connecting beam 340 can be a stainless steel material or a non-metallic material, which has certain elasticity and plasticity and cannot automatically expand the left ventricular outflow tract stent 300 when the delivery system is released, but can be expanded by the expansion force of the balloon of the delivery system to anchor the left ventricular outflow tract stent 300 to the inner wall of the left ventricular outflow tract 121.

[0062] The inflow end 360 of the left ventricular outflow tract stent 300 is provided with a receiving claw 350, which can be connected with the delivery system, on the one hand, to ensure that the left ventricular outflow tract stent 300 can be stably placed in the delivery system in the bundled state, and on the other hand, to facilitate the delivery system to stably release and anchor the left ventricular outflow tract stent 300 at the implantation position.

[0063] The embodiments of the present application also provide a delivery system for delivering the left ventricular outflow tract stent 300 provided by any of the embodiments of the present application.

[0064] The above descriptions are only the preferred embodiments of the present application, and are not intended to limit the present application. The present application can have various modifications and changes for those skilled in the art. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A left ventricular outflow tract stent, characterized in that, The stent (300) includes multiple connecting beams (340). When the stent (300) is in the open state, the connecting beams (340) abut against the inner wall of the left ventricular outflow tract (121), and at least a portion of the connecting beams (340) abut against the failed original leaflet (131) of the original mitral valve (130) to prevent the failed original leaflet (131) from blocking the left ventricular outflow tract (121) and to keep the left ventricular outflow tract (121) in a passable state. The connecting beam (340) has at least one barb (380). When the left ventricular outflow tract stent (300) is in the open state, the left ventricular outflow tract stent (300) is anchored to the inner wall of the left ventricular outflow tract (121) by a portion of the barb (380) and to the failed native leaflet (131) by another portion of the barb (380), or the barb (380) passes through the failed native leaflet (131) and is anchored to the native mitral valve or interventional mitral valve prosthesis (200). Multiple mesh openings (370) are formed between multiple connecting beams (340) so that the diameter of the left ventricular outflow tract stent (300) is D1; In the contracted state, the multiple connecting beams (340) of the left ventricular outflow tract stent (300) are pressed against each other, so that the diameter of the left ventricular outflow tract stent (300) is D2, where D2 < D1; When the left ventricular outflow tract stent (300) is in the open state, the connecting beam (340) is arc-shaped and arches away from the axis of the left ventricular outflow tract stent (300).

2. The left ventricular outflow tract stent according to claim 1, characterized in that, The left ventricular outflow tract stent (300) includes a first part (310) and a second part (320). When the left ventricular outflow tract stent (300) is in the open state, a recessed structure (330) is formed at the connection position of the first part (310) and the second part (320).

3. The left ventricular outflow tract stent according to claim 1 or 2, characterized in that, The connecting beam (340) is made of nickel-titanium shape memory alloy or cobalt-chromium alloy, and the left ventricular outflow tract stent (300) is anchored to the inner wall of the left ventricular outflow tract (121) by its own expansion force.

4. The left ventricular outflow tract stent according to claim 1 or 2, characterized in that, The connecting beam (340) is made of stainless steel or non-metallic material, and the left ventricular outflow tract stent (300) is anchored to the inner wall of the left ventricular outflow tract (121) by the expansion force of the balloon of the delivery system.

5. The left ventricular outflow tract stent according to claim 1 or 2, characterized in that, The inflow end (360) of the left ventricular outflow tract stent (300) is provided with an inflow claw (350).

6. The left ventricular outflow tract stent according to claim 1 or 2, characterized in that, The mesh (370) is a rhomboid shape.

7. A conveying system, characterized in that, The delivery system is used to deliver the left ventricular outflow tract stent (300) according to any one of claims 1-6.

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