Interventional valve with lined leaflets

Abstract

The present application relates to an interventional valve with lining leaflets, which includes a valve frame, a valve skirt, a plurality of main leaflets and lining leaflets, the valve frame includes an outflow end and an inflow end, the caliber of the outflow end is smaller than the caliber of the inflow end; the valve skirt is fixedly covered on the inner wall of the valve frame; the main leaflets are connected to the valve skirt; the lining leaflets are arranged between the valve skirt and the main leaflets, the first end of the lining leaflets is connected to the position of the valve skirt near the inflow end, the second end of the lining leaflets is kept at a distance from the valve skirt, and the second end of the lining leaflets is used to support the main leaflets when the interventional valve is in an open state. When the interventional valve provided by the present application is opened, the main leaflets are supported by the lining leaflets, and the portion between the end of the main leaflet connected to the valve skirt and the free end of the main leaflet is kept at a distance from the valve frame, and the distance can reduce the distance between the two main leaflets along the radial direction of the valve frame, thereby reducing the amount of blood swept by the main leaflet on its closed path, thereby reducing blood reflux.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an interventional valve with an inner-lined leaflet. Background Art

[0002] An ideal interventional valve would provide the largest effective opening area when open and minimize regurgitation when closed. However, existing interventional valves, when open, have leaflets that fit snugly against the skirt, creating a large gap between them. This results in a longer closing time and higher regurgitation. Furthermore, the leaflets rely on negative pressure to automatically close, resulting in a low pressure differential at the moment they begin closing. This prevents the leaflets from closing quickly and also prolongs their closure time. Summary of the Invention

[0003] The purpose of the present application is to provide an interventional valve with an inner-lined leaflet to solve the problem of large regurgitation volume of the leaflet during closing in the above-mentioned prior art.

[0004] The present application provides an interventional valve with a lined leaflet, comprising:

[0005] a valve frame, the valve frame comprising an outflow end and an inflow end, wherein the caliber of the outflow end is smaller than the caliber of the inflow end;

[0006] a petal skirt fixedly covering the inner wall of the petal frame;

[0007] A plurality of main leaflets, one end of each main leaflet being connected to the leaflet skirt and the other end of each main leaflet being a free end, wherein the plurality of main leaflets open or close the interventional valve through the free end;

[0008] The lining leaflet is arranged between the flap skirt and the main flap, the first end of the lining leaflet is connected to the flap skirt near the inflow end, the second end of the lining leaflet maintains a distance from the flap skirt, and the second end of the lining leaflet is used to support the main flap when the interventional valve is in an open state, so that a distance is maintained between the main flap and the flap skirt.

[0009] In a possible implementation, the lining leaflet includes a connecting portion, a bending portion, and a supporting portion, wherein the bending portion is arc-shaped, one end of the bending portion is fixedly connected to the connecting portion, and the other end of the bending portion is fixedly connected to the supporting portion;

[0010] The connecting portion is connected to the petal skirt;

[0011] The support portion is used to contact the main leaflet when the interventional valve is in an open state, and is used to support the main leaflet.

[0012] In a possible implementation, along the axial direction of the valve frame, the length dimension of the lining leaflet is 1 / 3 to 2 / 3 of the length dimension of the main leaflet.

[0013] In a possible implementation, the lining leaflet is a sheet-like structure or a block-like structure.

[0014] In a possible implementation, the lining leaflets are circumferentially arranged around the inner wall of the petal skirt.

[0015] In a possible implementation, the number of the lining leaflets is equal to the number of the main leaflets, and one lining leaflet cooperates with one corresponding main leaflet.

[0016] In a possible implementation, the lining leaflet is made of an elastic material, and the second end of the lining leaflet is used to support the main leaflet and provide thrust for the main leaflet when the interventional valve is in an open state.

[0017] In a possible implementation, the elastic material is pericardial material, silicone material or polyurethane material.

[0018] The technical solution provided by this application can achieve the following beneficial effects:

[0019] The interventional valve with lined leaflets provided in the present application, when the interventional valve is opened, the free end of the main leaflet swings open toward the side close to the valve frame. Supported by the lining leaflet, the area between the end of the main leaflet connected to the skirt and the free end of the main leaflet maintains a distance from the valve frame. This distance can reduce the distance between the two main leaflets at both ends along the radial direction of the valve frame, thereby reducing the space between each main leaflet, and further reducing the amount of blood located in the space. When the main leaflet is in the closing process, the amount of blood swept by the main leaflet on its closing path is reduced, that is, the amount of blood reflux caused by the main leaflet during the closing process is reduced.

[0020] It should be understood that the foregoing general description and the following detailed description are merely illustrative and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a diagram of the state of a traditional interventional valve when it is open;

[0022] Figure 2 This is a diagram of the state of a traditional interventional valve when it is closed;

[0023] Figure 3 A schematic structural diagram of an interventional valve provided in an embodiment of the present application;

[0024] Figure 4 A top view of an interventional valve provided in an embodiment of the present application;

[0025] Figure 5 A diagram showing the state of the interventional valve provided in an embodiment of the present application when it is open;

[0026] Figure 6 for Figure 5 The enlarged view at A in FIG.

[0027] Figure 7 A state diagram of the interventional valve provided in an embodiment of the present application when closed.

[0028] Reference numerals:

[0029] 100-petal frame;

[0030] 200- leaflets;

[0031] a-space;

[0032] H1-distance;

[0033] 1-valve frame;

[0034] 11-inflow end;

[0035] 12-Outflow end;

[0036] 2-main leaflet;

[0037] 21-free end;

[0038] 3-lined leaflets;

[0039] 31-connecting portion;

[0040] 32-bending portion;

[0041] 33-supporting part;

[0042] 4-petal skirt;

[0043] b-space;

[0044] H2-Distance.

[0045] 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 present application. DETAILED DESCRIPTION

[0046] In order to better understand the technical solution of the present application, the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0047] It should be clear that the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0048] The terms used in the embodiments of the present application are for the purpose of describing specific embodiments only and are not intended to limit the present application. The singular forms "a", "an", "the" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms unless the context clearly indicates otherwise.

[0049] It should be understood that the term "and / or" as used herein is merely a description of the relationship between associated objects, indicating that three possible relationships exist. For example, "A and / or B" can represent: A exists alone, A and B exist simultaneously, or B exists alone. Furthermore, the character " / " in this document generally indicates that the associated objects are in an "or" relationship.

[0050] It should be noted that the directional words such as "upper", "lower", "left", and "right" described in the embodiments of the present application are described based on the angles shown in the accompanying drawings and should not be understood as limiting the embodiments of the present application. In addition, in the context, it should be understood that when it is mentioned that an element is connected to another element "on" or "under", it can not only be directly connected to the other element "on" or "under", but also be indirectly connected to the other element "on" or "under" through an intermediate element.

[0051] like Figure 1 and Figure 2 As shown, for a traditional interventional valve, in the expanded state, the inner wall of the valve frame 100 is an arc convex outward, and the valve skirt fixed on the valve frame 100 is also expanded along with the valve frame 100 and is arc-shaped. When the interventional valve is opened, the leaflets 200 separate from each other and will eventually stick to the inner surface of the valve skirt. The distance H1 between the leaflets 200 at both ends along the radial direction of the valve frame 100 is large, resulting in a larger space a between the leaflets 200. More blood is filled in the space a. When the leaflets 200 are in the closing process, the amount of blood swept by the leaflets 200 on their closing path is large. This part of the blood swept by the leaflets 200 is the blood that causes reflux, thereby increasing the amount of blood reflux.

[0052] like Figures 3 to 7As shown, the present application provides an interventional valve with lining leaflets, which can be an interventional mitral valve, interventional tricuspid valve, etc. The interventional valve includes a valve frame, a valve skirt, lining leaflets, and multiple main leaflets. The valve frame includes an outflow end and an inflow end, and the caliber of the outflow end is smaller than the caliber of the inflow end. The valve skirt is fixedly covered on the inner wall of the valve frame, one end of the main leaflet is connected to the valve skirt, and the other end of the main leaflet is a free end. The multiple main leaflets open or close the interventional valve through the free end.

[0053] Among them, the lining leaflet 3 is arranged between the valve skirt 4 and the main leaflet 2, the first end of the lining leaflet 3 is connected to the valve skirt 4 near the inflow end 11, and the second end of the lining leaflet 3 maintains a distance from the valve skirt 4. The second end of the lining leaflet 3 is used to support the main leaflet 2 when the interventional valve is in an open state.

[0054] It should be noted that, in order to ensure that the blood flowability meets the requirements when the interventional valve is in the open state, it is necessary to ensure that the outflow end 12 has an effective opening area that meets the requirements. That is to say, when the interventional valve is designed, there is almost no space for arranging the lining leaflets 3 between the main leaflets 2 and the valve frame 1 near the outflow end 12. If the lining leaflets 3 are arranged between the main leaflets 2 and the valve frame 1 near the outflow end 12, the effective opening area will be reduced, and the blood flowability cannot be guaranteed. For this reason, in this embodiment, the caliber of the inflow end 11 of the interventional valve is larger than the caliber of the outflow end 12, so that the lining leaflets 3 can be arranged between the main leaflets 2 and the valve frame 1 near the inflow end 11. Even if the arrangement of the lining leaflets 3 causes the caliber of the inflow end 11 to be reduced, it will not affect the caliber of the outflow end 12, that is, it will not affect the effective opening area of ​​the outflow end 12.

[0055] Among them, the diameter of the inflow end 11 is larger than the diameter of the outflow end 12. It is also necessary to ensure that after the lining leaflet 3 is set, the diameter of the inflow end 11 after reduction is still not smaller than the diameter of the outflow end 12 to ensure good blood flow.

[0056] When the interventional valve opens, Figure 5 As shown, the free end 21 of the main leaflet 2 swings open toward the side close to the valve frame 1. Supported by the lining leaflet 3, a distance is maintained between the end of the main leaflet 2 connected to the skirt 4 and the free end 21 of the main leaflet 2 and the valve frame 1. This distance can reduce the distance H2 between the main leaflets 2 at both ends along the radial direction of the valve frame 1, thereby reducing the space b between each main leaflet 2, and further reducing the amount of blood located in the space b. When the main leaflet 2 is in the closing process, the amount of blood swept by the main leaflet 2 on its closing path is reduced, that is, the reflux of blood caused by the main leaflet 2 during the closing process is reduced.

[0057] It should be noted that the amount of regurgitation during the closure of the interventional valve, in addition to the amount of blood swept by the main leaflets 2 along their closing path, also includes increased regurgitation caused by the extended time required for the leaflets to complete their coaptation. It is understood that the main leaflets 2 close primarily through negative pressure. However, at the moment the main leaflets begin to close, due to high blood flow and low negative pressure, the main leaflets 2 cannot initiate the closure action quickly and can only close gradually, causing significant blood regurgitation.

[0058] In this embodiment, the lining leaflet 3 can be made of elastic material, and the second end of the lining leaflet 3 is used to support the main leaflet 2 when the interventional valve is in the open state and provide thrust for the main leaflet 2.

[0059] Among them, the material of the lining leaflet 3 can be but is not limited to pericardial material, silicone material or polyurethane material. These materials can make the lining leaflet 3 elastically deform when under pressure, and can restore the deformation when not under pressure or the pressure is reduced.

[0060] Specifically, when the main valve leaflet 2 moves toward the valve frame 1 to open, the main valve leaflet 2 can squeeze the lining valve leaflet 3, causing the lining valve leaflet 3 to elastically deform, and the lining valve leaflet 3 will push the main valve leaflet 2 away from the valve frame 1. When the main valve leaflet 2 needs to start closing, the lining valve leaflet 3 will use its own elastic force to push the main valve leaflet 2 to start closing more quickly, enabling the main valve leaflet 2 to move more quickly away from the valve frame 1, that is, enabling the main valve leaflet 2 to complete the closing action more quickly, shortening the closing time, and thus reducing blood backflow during the closing process of the main valve leaflet 2.

[0061] Specifically, if Figure 6 As shown, the lining leaflet 3 includes a connecting portion 31, a bending portion 32 and a supporting portion 33. The bending portion 32 is arc-shaped, one end of the bending portion 32 is fixedly connected to the connecting portion 31, and the other end of the bending portion 32 is fixedly connected to the supporting portion 33; the connecting portion 31 is connected to the leaflet skirt 4; the supporting portion 33 is used to contact the main leaflet 2 when the interventional valve is in an open state, and is used to support the main leaflet 2.

[0062] Among them, the bending portion 32 can make the connecting portion 31 and the supporting portion 33 bend to the same side, so that the supporting portion 33 can be closer to the connecting portion 31 when squeezed by the main lobe 2, thereby causing the bending portion 32 to produce major elastic deformation. The rebound force of the bending portion 32 can act on the main lobe 2 through the supporting portion 33, thereby pushing the main lobe 2 to quickly close.

[0063] In order to facilitate the processing and manufacturing of the lining leaflet 3, the lining leaflet 3 can be integrally formed.

[0064] Specifically, the lining leaflet 3 is a sheet-like structure or a block-like structure. The lining leaflet 3 can be a long elastic block or a thin sheet structure. In order to provide uniform elastic force to the main leaflet 2, the lining leaflet 3 is preferably a thin sheet structure.

[0065] Specifically, along the axial direction of the valve frame 1, the length of the lining leaflet 3 is 1 / 3 to 2 / 3 of the length of the main leaflet 2. Within this size range, the lining leaflet 3 can apply thrust to the middle and lower area of ​​the main leaflet 2, thereby ensuring that the main leaflet 2 can open smoothly while providing thrust for closing, ensuring the effective opening area of ​​the outflow end 12, and avoiding excessive resistance to the opening of the main leaflet 2 caused by the lining leaflet 3 being too long.

[0066] The lining leaflets 3 can be sewn onto the petal skirt 4 .

[0067] In another specific embodiment, the number of lining leaflets 3 is equal to the number of main leaflets 2, with one lining leaflet 3 cooperating with one corresponding main leaflet 2. That is, for an interventional valve with two main leaflets 2, two lining leaflets 3 are also provided, while for an interventional valve with three main leaflets 2, three lining leaflets 3 are also provided. Each lining leaflet 3 corresponds only to one main leaflet 2, thereby better applying a propulsive force to the corresponding main leaflet 2 without affecting or being affected by other main leaflets 2.

[0068] In addition, the number of lining leaflets 3 may not be equal to the number of main leaflets 2. For example, for an interventional valve with four main leaflets 2 (quadruple leaflet), the number of lining leaflets 3 may be less than four, such as only two lining leaflets 3 are provided, and the two lining leaflets 3 cooperate with any two of the four main leaflets 2.

[0069] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. An interventional valve with lined leaflets, characterized in that: include: A valve frame (1), the valve frame (1) comprising an outflow end (12) and an inflow end (11), wherein the caliber of the outflow end (12) is smaller than the caliber of the inflow end (11); A petal skirt (4), the petal skirt (4) being fixedly covered on the inner wall of the petal frame (1); a plurality of main leaflets (2), one end of each main leaflet (2) being connected to the valve skirt (4), the other end of each main leaflet (2) being a free end (21), and the plurality of main leaflets (2) enabling the interventional valve to be opened or closed via the free end (21); a lining leaflet (3), the lining leaflet (3) being arranged between the flap skirt (4) and the main flap (2), the first end of the lining leaflet (3) being connected to the flap skirt (4) at a position close to the inflow end (11), the second end of the lining leaflet (3) being kept at a distance from the flap skirt (4), the second end of the lining leaflet (3) being used to support the main flap (2) when the interventional valve is in an open state, so that a distance is kept between the main flap (2) and the flap skirt (4); The lining leaflet (3) comprises a connecting portion (31), a bending portion (32) and a supporting portion (33); the bending portion (32) is arc-shaped, one end of the bending portion (32) is fixedly connected to the connecting portion (31), and the other end of the bending portion (32) is fixedly connected to the supporting portion (33); the connecting portion (31) is connected to the leaflet skirt (4); the supporting portion (33) is used to contact the main leaflet (2) when the interventional valve is in an open state, and is used to support the main leaflet (2); The lining leaflet (3) is made of elastic material, and the second end of the lining leaflet (3) is used to support the main leaflet (2) when the interventional valve is in an open state and provide thrust for the main leaflet (2).

2. The interventional valve with lined leaflets according to claim 1, characterized in that: Along the axial direction of the valve frame (1), the length dimension of the lining valve leaflet (3) is 1 / 3 to 2 / 3 of the length dimension of the main valve leaflet (2).

3. The interventional valve with lined leaflets according to claim 1, characterized in that: The lining leaflet (3) is a sheet-like structure or a block-like structure.

4. The interventional valve with lined leaflets according to claim 1, characterized in that: The lining leaflets (3) are circumferentially arranged around the inner wall of the petal skirt (4).

5. The interventional valve with lined leaflets according to claim 1, characterized in that: The number of the lining leaflets (3) is equal to the number of the main leaflets (2), and one lining leaflet (3) cooperates with one corresponding main leaflet (2).

6. The interventional valve with lined leaflets according to claim 1, characterized in that: The elastic material is pericardial material, silica gel material or polyurethane material.

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