CN115177407A

CN115177407A - Left ventricle outflow tract support and conveying system

Info

Publication number: CN115177407A
Application number: CN202210805283.1A
Authority: CN
Inventors: 钟生平; 靳永富; 孟春旺
Original assignee: Kingstronbio Changshu Co ltd
Current assignee: Kingstronbio Changshu Co ltd
Priority date: 2022-07-08
Filing date: 2022-07-08
Publication date: 2022-10-14

Abstract

The application relates to a left ventricle outflow tract support and conveying system, wherein, this left ventricle outflow tract support includes a plurality of tie-beams, and left ventricle outflow tract support is under the state of strutting, and the tie-beam just at least partial tie-beam butt is on the leaflet that has failed of native mitral valve with the inner wall butt of left ventricle outflow tract. This left ventricle outflow tract support is in under the state of strutting, the coupling beam near mitral valve one side can the butt on native leaflet, make native leaflet can be extruded and intervene between the left ventricle outflow tract support that mitral valve prosthesis and this embodiment provided, when the left ventricle is in the shrink phase, native leaflet can be intervene that mitral valve prosthesis and this embodiment provided left ventricle outflow tract support spacing, can not rock at will along with the blood flow, thereby can effectively avoid native leaflet to the sheltering from of left ventricle outflow tract, guarantee that blood can normally flow to the aorta from the left ventricle.

Description

Left ventricle outflow tract support and conveying system

Technical Field

The application relates to the technical field of medical equipment, in particular to a left ventricular outflow tract stent and a conveying system.

Background

After the mitral valve is implanted, the intervention valve extrudes the left ventricle outflow tract to make the left ventricle outflow tract become narrow; meanwhile, due to the blocking of the intervention valve frame, in the contraction period of the left ventricle, the native mitral valve leaflets cannot rotate in the direction of the mitral valve, and can rotate towards one side of the aorta under the impact of blood flow to further block the outflow tract of the left ventricle, thereby blocking the blood flow.

Disclosure of Invention

The application aims to provide a left ventricular outflow tract stent and a delivery system, so as to solve the problem of blood flow obstruction caused by left ventricular outflow tract stenosis due to implantation of a mitral valve intervention valve in the prior art.

The first aspect of the present application provides a left ventricular outflow tract stent, wherein, including a plurality of tie-beams, left ventricular outflow tract stent is under the state of strutting, the inner wall butt of tie-beam and left ventricular outflow tract, and at least partial tie-beam butt is on native mitral valve's the leaflet that has failed to avoid the native leaflet that has failed to block left ventricular outflow tract, make left ventricular outflow tract keep the access state all the time.

In one possible design, the connecting beam has at least one barb thereon, and the left ventricular outflow tract stent is anchored in the expanded state by a portion of the barb to the inner wall of the left ventricular outflow tract, by another portion of the barb to the native valve leaflet that has failed or by passing the barb through the native valve leaflet that has failed to anchor to the native mitral valve or an interventional mitral valve prosthesis.

In one possible design, a plurality of mesh openings are formed between the plurality of connecting beams, so that the diameter of the left ventricular outflow tract stent is D1;

the left ventricle outflow tract bracket is in a contraction state, a plurality of connecting beams are in mutual extrusion contact, the diameter of the left ventricle outflow tract bracket is D2, and D2 is less than D1.

In a possible design, the connection beam is arc-shaped when the left ventricular outflow tract stent is in the expanded state, and the connection beam is arched in a direction away from the axis of the left ventricular outflow tract stent.

In one possible design, the left ventricular outflow tract stent comprises a first portion and a second portion, and the left ventricular outflow tract stent forms a concave structure at a connecting position of the first portion and the second portion in an expanded state.

In one possible design, the connecting beam is made of a nickel-titanium memory alloy material or a cobalt-chromium alloy material, and the left ventricular outflow tract stent is anchored on the inner wall of the left ventricular outflow tract through self-expansion force.

In one possible design, the connecting beam is made of stainless steel or non-metal material, and the stent is anchored to the inner wall of the left ventricular outflow tract by being expanded by the balloon of the delivery system.

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

In one possible design, the mesh is diamond shaped.

The second aspect of the present application also provides a delivery system for delivering the left ventricular outflow tract stent provided by the first aspect of the present application.

The technical scheme provided by the application can achieve the following beneficial effects:

the application provides a left ventricle outflow tract support and conveying system, be in under the state of strutting at this left ventricle outflow tract support, the coupling beam that is close to mitral valve one side can the butt on native leaflet, make native leaflet can be extruded and intervene between the left ventricle outflow tract support that mitral valve prosthesis and this embodiment provided, when the left ventricle is in the systolic phase, native leaflet can be intervene the left ventricle outflow tract support that mitral valve prosthesis and this embodiment provided spacing, can not rock at will along with the blood flow, thereby can effectively avoid native leaflet to the sheltering from of left ventricle outflow tract, guarantee that blood can normally flow to the aorta from the left ventricle.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

FIG. 1 is a schematic view of a portion of a human heart;

FIG. 2 is a view of the interventional mitral valve prosthesis after implantation;

FIG. 3 is a schematic structural diagram of a left ventricular outflow tract stent according to an embodiment of the present disclosure;

FIG. 4 is a view of a left ventricular outflow tract stent and an interventional mitral valve prosthesis provided in accordance with an embodiment of the present application after implantation;

fig. 5 is a schematic structural diagram (ii) of a left ventricular outflow tract stent provided in the embodiment of the present application.

Reference numerals are as follows:

100-heart;

110-left atrium;

120-left ventricle;

121-left ventricular outflow tract;

130-mitral valve;

131-native leaflets;

140-aortic valve;

200-intervention mitral valve prosthesis;

300-left ventricular outflow tract stent;

310-a first portion;

320-a second portion;

330-a concave structure;

340-connecting beams;

350-receiving claw;

360-inflow end;

370-mesh;

380-barbs.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and together with the description, serve to explain the principles of the application.

Detailed Description

For better understanding of the technical solutions of the present application, the following detailed descriptions of the embodiments of the present application are provided with reference to the accompanying drawings.

It should be understood that the embodiments described are only a few embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

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 application. As used in the examples of this 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.

It should be understood that the term "and/or" as used herein is merely a relationship that describes an associated object, meaning that three relationships may exist, e.g., a and/or B, may represent: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

It should be noted that the terms "upper", "lower", "left", "right", and the like used in the embodiments of the present application are described in terms of the angles shown in the drawings, and should not be construed as limiting the embodiments of the present application. In addition, in this context, it will also be understood that when an element is referred to as being "on" or "under" another element, it can be directly on "or" under "the other element or be indirectly on" or "under" the other element via an intermediate element.

The human heart 100 includes four chambers, the left atrium 110, the left ventricle 120, the right atrium, and the right ventricle. Wherein, upon diastole of the left atrium 110, blood may be drawn back to the left atrium 110; as the left atrium 110 contracts, blood enters the left ventricle 120; upon contraction of the left ventricle 120, blood may be pumped into the aorta via the left ventricular outflow tract 121. Wherein, the mitral valve 130 is arranged between the left atrium 110 and the left ventricle 120, the aortic valve 140 is arranged between the left ventricular outflow tract 121 and the aorta, and both the mitral valve 130 and the aortic valve 140 can prevent the blood from flowing, and play an important role in ensuring the normal blood circulation of the heart 100.

Mitral valve 130 is a main portion of heart 100 that is diseased, and when mitral valve 130 fails, if native leaflets 131 are not closed effectively, resulting in partial confluence of blood, intervention mitral valve prosthesis 200 is usually used to replace native mitral valve. Interventional mitral valve prosthesis 200 is implanted to the location of the native mitral valve by a dedicated delivery system, and native leaflets 131 are not removed but are blocked outside of interventional mitral valve prosthesis 200 after the interventional mitral valve prosthesis 200 is expanded, so that native leaflets 131 are in a "free" state, and native leaflets 131 can freely shake with the blood stream due to the impact of the blood stream.

During systole of left ventricle 120, left ventricular outflow tract 121 narrows, and since native leaflets 131 are not rotated in the direction of mitral valve 130 by the supporting action of interventional mitral valve prosthesis 200, native leaflets 131 are rotated in the direction of aortic valve 140 by the impact of blood flow, which can block left ventricular outflow tract 121, resulting in further narrowing of left ventricular outflow tract 121. This can easily cause blood flow blockage and may not allow sufficient blood flow to be pumped into the aorta.

The present application provides a left ventricular outflow tract stent 300, which comprises a plurality of connecting beams 340, wherein the connecting beams 340 abut against the inner wall of the left ventricular outflow tract 121 of the left ventricular outflow tract stent 300 in the expanded state, and at least part of the connecting beams 340 abut against the failed native valve leaflets 131 of the native mitral valve 130, so as to prevent the failed native valve leaflets from blocking the left ventricular outflow tract, and keep the left ventricular outflow tract in an access state all the time.

When the left ventricle 120 is in the contraction phase, the native leaflets 131 can be limited by the intervention mitral valve prosthesis 200 and the left ventricle outflow tract support 300 provided in this embodiment, and will not shake randomly along with the blood flow, so that the native leaflets 131 can be effectively prevented from shielding the left ventricle outflow tract 121, and the blood can be ensured to flow normally from the left ventricle 120 to the aorta.

Specifically, as shown in fig. 5, the connecting beam 340 has at least one barb 380 thereon, and in the expanded state of the left ventricular outflow tract stent 300, 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, to the failed native valve leaflet 131 by another portion of the barb 380, or to the native mitral valve or interventional mitral valve prosthesis 200 through the failed native valve leaflet 131. When the left ventricular outflow tract stent 300 is implanted and expanded, part of the connecting beam 340 can abut against the inner wall tissue of the left ventricular outflow tract 121, and the barbs 380 can hook on the inner wall tissue of the left ventricular outflow tract 121, so that the left ventricular outflow tract stent 300 is prevented from shifting or rotating, and the anchoring reliability is ensured. Meanwhile, barbs 380 on the left ventricular outflow tract stent 300 towards the mitral valve side may be anchored to the failed native valve leaflet 131, or barbs 380 may penetrate through the failed native valve leaflet 131 and then be anchored to the native mitral valve or the intervention mitral valve prosthesis 200, so that the failed native valve leaflet 131 is restrained from shaking by the anchoring effect of the barbs 380, and blocking of the left ventricular outflow tract 121 is avoided.

Specifically, a plurality of mesh openings 370 are formed between the plurality of connection beams 340 such that the diameter of the left ventricular outflow tract stent 300 is D1. In the collapsed state of the left ventricular outflow tract stent 300, the plurality of connecting beams 340 are in mutual pressing contact, so that the diameter of the left ventricular outflow tract stent 300 is D2, and D2 is less than D1.

The left ventricular outflow tract stent 300 can be manufactured by a tubular blank through a laser cutting process or a manual cutting process, so as to form a plurality of meshes 370, a connecting beam 340 is formed between the meshes 370, and the connecting beam 340 has certain elasticity, so that the left ventricular outflow tract stent 300 can be switched and deformed between a contraction state and an expansion state. Specifically, when the left ventricular outflow tract stent 300 is in the constrained state, the connecting beams 340 are pressed against each other by their own deformation, so that the left ventricular outflow tract stent 300 is changed into a thin tube shape with a smaller diameter D2, and can be placed in a delivery system, by which the left ventricular outflow tract stent 300 can be delivered to the left ventricular outflow tract 121. At the implantation position, the left ventricular outflow tract stent 300 in the constrained state can be automatically expanded after the delivery system is released, or can be expanded by a balloon of the delivery system, and the diameter D1 of the left ventricular outflow tract stent 300 in the expanded state is larger and can be anchored on the inner wall of the left ventricle 120 to which the left ventricle flows, thereby completing the implantation operation.

In addition, by forming the plurality of mesh openings 370 and the plurality of connection beams 340 with elasticity on the left ventricular outflow tract stent 300, the left ventricular outflow tract stent 300 can be deformed correspondingly with the contraction or relaxation of the left ventricle 120, and the normal movement of the tissue of the left ventricle 120 is ensured. Wherein, in order to facilitate the deformation of the left ventricular outflow tract stent 300, the meshes 370 may be diamond-shaped holes.

Specifically, in the expanded state of the left ventricular outflow tract stent 300, the connection beam 340 is arc-shaped, and the connection beam 340 is arched in a direction away from the axis of the left ventricular outflow tract stent 300.

Under the state of strutting, the tie beam 340 needs to butt on the inner wall of left ventricle outflow tract 121, because the tissue of the inner wall of left ventricle outflow tract 121 is softer, the inner wall tissue of left ventricle outflow tract 121 can be extruded to curved tie beam 340, make the extruded tissue form the same shape with curved tie beam 340, at this moment, the tissue that is extruded can be laminated completely with the surface of tie beam 340, can increase the contact surface of tie beam 340 and tissue on the one hand, curved faying surface on the other hand, can produce the extrusion force of all directions in left ventricle outflow tract support 300 axial direction, prevent this left ventricle outflow tract support 300 at axial float, guarantee the stability of left ventricle outflow tract support 300 implantation position.

Specifically, the left ventricular outflow tract stent 300 includes a first portion 310 and a second portion 320, and the left ventricular outflow tract stent 300 forms a concave structure 330 at a connecting position of the first portion 310 and the second portion 320 in the expanded state.

Under the strutting state, the connecting beams 340 of the first part 310 and the second part 320 are both arc-shaped and arch in the direction away from the axis of the left ventricular outflow tract bracket 300, so that two wave crests can be formed on the outer side of the left ventricular outflow tract bracket 300 in the axial direction and can be abutted against the inner wall tissue of the left ventricular outflow tract 121, and the anchoring and axial limiting are realized. The concave structure 330 is formed at the position between the two wave crests, so that when the two wave crests squeeze 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 sink into the concave structure 330 and can be abutted against the surface of the concave structure 330, thereby increasing the contact area between the left ventricular outflow tract bracket 300 and the inner wall of the left ventricular outflow tract 121, further realizing axial limiting, and ensuring the anchoring reliability of the left ventricular outflow tract bracket 300. In addition, it should be noted that the recessed structure 330 near the native valve leaflet 131 can make the native valve leaflet 131 be accommodated in the recessed structure 330, so as to avoid the impact of blood on the native valve leaflet 131, thereby alleviating the blockage of the native valve leaflet 131 to the blood flow, ensuring smooth flow of the blood, and avoiding the native valve leaflet 131 from swinging due to the impact of the blood flow to block the inflow end 360 of the left ventricular outflow tract stent 300.

Specifically, in one embodiment, the material of the connecting beam 340 may 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 by its own expansive force after the delivery system is released.

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

The inflow end 360 of the left ventricular outflow tract stent 300 is provided with a receiving claw 350, and the receiving claw 350 can be connected with a delivery system, so that on one hand, the left ventricular outflow tract stent 300 can be stably placed in the delivery system in a constrained state, and on the other hand, the delivery system can stably release and anchor the left ventricular outflow tract stent 300 at an implantation position.

Embodiments of the present application also provide a delivery system for delivering the left ventricular outflow tract stent 300 provided in any of the embodiments of the present application.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like 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 by comprising a plurality of connecting beams (340), wherein the left ventricular outflow tract stent (300) is in a spreading state, the connecting beams (340) are abutted with the inner wall of a left ventricular outflow tract (121), and at least part of the connecting beams (340) are abutted on a native valve leaflet (131) of a native mitral valve (130) which has failed, so as to prevent the native valve leaflet (131) which has failed from blocking the left ventricular outflow tract (121), and enable the left ventricular outflow tract (121) to keep an access state all the time.

2. The lv outflow tract stent according to claim 1, wherein the connecting beam (340) has at least one barb (380) thereon, and the lv outflow tract stent (300) is in a stretched state, and the lv outflow tract stent (300) is anchored to the inner wall of the lv outflow tract (121) by a portion of the barb (380), to the failed native leaflet (131) by another portion of the barb (380), or to the native mitral valve or interventional mitral valve prosthesis (200) by passing the barb (380) through the failed native leaflet (131).

3. The left ventricular outflow tract stent according to claim 1, wherein a plurality of mesh openings (370) are formed between a 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 support (300) is in a constrained state, the connecting beams (340) are in mutual extrusion contact, so that the diameter of the left ventricular outflow tract support (300) is D2, and D2 is smaller than D1.

4. The lv outflow tract stent according to claim 1, wherein the connecting beam (340) is arc-shaped in the expanded state of the lv outflow tract stent (300), and the connecting beam (340) is arched in a direction away from the axis of the lv outflow tract stent (300).

5. A left ventricular outflow tract stent according to claim 1, characterized in that the left ventricular outflow tract stent (300) comprises a first portion (310) and a second portion (320), the left ventricular outflow tract stent (300) in a distracted state forming a concave structure (330) at the connection location of the first portion (310) and the second portion (320).

6. The left ventricular outflow tract stent according to any one of claims 1 to 5, wherein the material of the connecting beam (340) is a nickel-titanium memory alloy material or a cobalt-chromium alloy material, and the left ventricular outflow tract stent (300) is anchored on the inner wall of the left ventricular outflow tract (121) by self-expansion force.

7. The left ventricular outflow tract stent according to any one of claims 1 to 5, wherein the material of the connection beam (340) is stainless steel material or non-metal material, and the left ventricular outflow tract stent (300) is anchored to the inner wall of the left ventricular outflow tract (121) by being expanded by the expansion force of a balloon of a delivery system.

8. A left ventricular outflow tract stent according to any one of claims 1 to 5, characterized in that the inflow end (360) of the left ventricular outflow tract stent (300) is provided with a receiving claw (350).

9. A left ventricular outflow tract stent according to any one of claims 1 to 5, wherein the meshes (370) are rhombic holes.

10. A delivery system for delivering a left ventricular outflow tract stent (300) according to any one of claims 1-8.