Barbed inner frame and artificial heart valve stent for mitral valve replacement

Abstract

The utility model provides a barbed inner frame and artificial heart valve stent for mitral valve replacement in the technical field of medical devices, wherein the inner frame comprises an inflow end layer and an outflow end layer. The inflow end layer and the outflow end layer are sequentially arranged on the inner frame, and the inflow end layer is arranged on one layer of the inner frame, and the outflow end layer is arranged on another layer of the inner frame. The inflow end layer and the outflow end layer comprise frame units and connection areas, and the connection areas are arranged on both sides of the frame units. Barbs are arranged on multiple connection areas of the inflow end layer, and barbs are arranged in multiple frame units of the outflow end layer. The inner frame of the utility model pierces the leaflets of the native mitral valve through multiple barbs on the inflow end layer and multiple barbs on the outflow end layer, so that the mitral valve artificial heart valve using the inner frame of the utility model is more firmly anchored to the native mitral valve and remains stable and does not shift.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and in particular to a barbed inner frame and an artificial heart valve stent for mitral valve replacement. Background Art

[0002] The mitral valve is a two-valve valve attached to the periphery of the left atrioventricular orifice, connected to the papillary muscles by chordae tendineae. It prevents blood from the left ventricle from flowing back to the left atrium, functioning as a one-way valve. Mitral regurgitation is a common heart valve disease. Severe mitral regurgitation can cause left ventricular enlargement, leading to left ventricular contractile dysfunction and subsequent heart failure, as well as left atrial enlargement, causing atrial fibrillation and pulmonary hypertension.

[0003] Traditional surgical operation is currently the main treatment for mitral regurgitation, but it has the disadvantages of large trauma, many complications, and high mortality. Therefore, in recent years, the replacement devices used in transcatheter valve replacement surgery have become the research and development hotspot of heart valve interventional treatment devices due to their low trauma and high safety.

[0004] Currently, technical personnel in this field are committed to developing a transcatheter mitral valve artificial heart valve that is feasible for clinical surgical operation and safe and effective. However, due to the special position of the mitral valve in the heart and the special structure of the mitral valve ring, the working condition of the mitral valve is more complicated than that of the aortic valve. In order to improve the success rate of transcatheter valve replacement surgery, the mitral valve artificial heart valve needs to be stable and not displaced after implantation. Therefore, how to improve the stability of the valve anchoring function and make the structure simple and reliable is the design difficulty of the transcatheter mitral valve artificial heart valve. Utility Model Content

[0005] In view of the defects in the prior art, the purpose of the utility model is to provide a barbed inner frame and an artificial heart valve stent for mitral valve replacement.

[0006] According to the utility model, a barbed inner frame for mitral valve replacement is provided, wherein the inner frame comprises an inflow end layer and an outflow end layer;

[0007] The inflow end layer and the outflow end layer are sequentially arranged on the inner frame, and the inflow end layer is arranged on one layer of the inner frame, and the outflow end layer is arranged on another layer of the inner frame;

[0008] The inflow end layer and the outflow end layer include a frame unit and a connection area, and the connection area is arranged on both sides of the frame unit;

[0009] The plurality of connection areas of the inflow end layer are provided with barbs, and the plurality of frame units of the outflow end layer are provided with barbs;

[0010] The inner frame pierces the leaflets of the native valve through the multiple barbs on the inflow end layer and the multiple barbs on the outflow end layer, so that the artificial heart valve using the inner frame is anchored more firmly to the native valve.

[0011] In some embodiments, the inflow end layer includes a plurality of inflow end layer frame units and a plurality of inflow end layer connection areas, and the plurality of inflow end layer frame units are connected to each other;

[0012] The plurality of said inflow end layer frame units include hollow gyro-shaped inflow end layer frame units, and a single said inflow end layer connection area is set as an area where two adjacent said inflow end layer frame units are connected to each other;

[0013] In some embodiments, the outflow end layer includes a plurality of outflow end layer frame units and a plurality of outflow end layer connection regions, and the plurality of outflow end layer frame units are connected to each other;

[0014] And the plurality of outflow end layer frame units include hollow gyro-shaped outflow end layer frame units, and a single outflow end layer connection area is configured as an area where two adjacent outflow end layer frame units are connected to each other.

[0015] In some embodiments, the inflow end layer frame unit includes a first protrusion and a second protrusion, the first protrusion is protruding toward one end along the vertical axis direction of the inflow end layer frame unit, the second protrusion is protruding toward the other end along the vertical axis direction of the inflow end layer frame unit, the protrusion direction of the first protrusion is opposite to the protrusion direction of the second protrusion, and a connecting arm is centrally arranged inside the second protrusion;

[0016] The inflow end layer frame unit further comprises a first connection portion and a second connection portion, wherein the first connection portion is arranged between the first protrusion and the inflow end layer connection area, and the second connection portion is arranged between the second protrusion and the inflow end layer connection area;

[0017] The barb is centrally arranged on the inflow end layer connection area between two adjacent inflow end layer frame units.

[0018] In some embodiments, a terminal is disposed at one end of the connecting arm, and a plurality of connecting holes are disposed on the terminal.

[0019] In some embodiments, the outflow end layer frame unit includes a third protrusion and a fourth protrusion, the third protrusion is protruding toward one end along the vertical axis direction of the outflow end layer frame unit, the fourth protrusion is protruding toward the other end along the vertical axis direction of the outflow end layer frame unit, the protrusion direction of the third protrusion is opposite to the protrusion direction of the fourth protrusion, and the barb is centrally arranged inside the fourth protrusion;

[0020] The outflow end layer frame unit further includes a third connection portion and a fourth connection portion, wherein the third connection portion is disposed between the third protrusion and the outflow end layer connection region, and the fourth connection portion is disposed between the fourth protrusion and the outflow end layer connection region.

[0021] In some embodiments, the outer side of the fourth protrusion is connected to a suture portion, a suture hole is provided on the suture portion, and the fourth protrusion and the suture portion adopt an integrated connection structure.

[0022] In some embodiments, the first protrusion includes a first protrusion in the shape of a large "X", and the second protrusion includes a second protrusion in the shape of a large "X";

[0023] The third protrusion includes a third protrusion in the shape of a small "X", and the fourth protrusion includes a fourth protrusion in the shape of a small "X".

[0024] In some embodiments, the bending angles of the connecting arm and the barb are both set at 10° to 45°.

[0025] A heart valve stent comprises the above-mentioned barbed inner stent for mitral valve replacement.

[0026] Compared with the prior art, the utility model has the following beneficial effects:

[0027] 1. The utility model provides barbs on multiple connection areas of the inflow end layer and barbs in multiple frame units of the outflow end layer. During the surgical implantation process, the multiple barbs on the inflow end layer and the multiple barbs on the outflow end layer of the utility model pierce into the leaflets of the native valve, so that the mitral valve artificial heart valve using the inner frame of the utility model is more firmly anchored with the native mitral valve, and remains stable and does not shift, which is conducive to the smooth progress of the operation and improves the success rate of the operation. At the same time, the utility model has a simple structure and is easy to produce;

[0028] 2. The utility model adopts a radial interference structure through the inner frame, and designs the inner frame diameter to be larger than the diameter of the native mitral valve upper ring, so as to facilitate the insertion of the barbs on the inner frame into the native mitral valve upper ring to play an anchoring and strengthening role. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Other features, objects and advantages of the present invention will become more apparent by reading the detailed description of non-limiting embodiments with reference to the following drawings:

[0030] Figure 1 It is a schematic diagram of the axonometric structure of the internal frame with barbs for mitral valve replacement according to the utility model;

[0031] Figure 2This is a schematic diagram of the main structure of the barbed inner frame for mitral valve replacement according to the utility model;

[0032] Figure 3 It is a side view structural schematic diagram of the internal frame with barbs for mitral valve replacement of the utility model;

[0033] Figure 4 It is a schematic diagram of the top view of the structure of the inner frame with barbs for mitral valve replacement according to the utility model;

[0034] Figure 5 It is a partial enlarged structural schematic diagram of the internal frame with barbs for mitral valve replacement of the utility model;

[0035] Figure 6 The utility model is a schematic diagram of the structure of an artificial heart valve stent including a barbed inner frame for mitral valve replacement.

[0036] Reference numerals:

[0037] Inner frame 1 Fourth protrusion 124

[0038] Inflow end layer 11 Sewing portion 125

[0039] Inflow end layer frame unit 111 suture hole 1251

[0040] Inflow end layer connection area 112 Third connection portion 126

[0041] First protruding portion 113 Fourth connecting portion 127

[0042] The second protrusion 114 connects the arm 13

[0043] First connection portion 115 terminal 131

[0044] Second connection portion 116 Connection hole 132

[0045] Outflow end layer 12 barb 14

[0046] Outflow end layer frame unit 121 valve positioning member 2

[0047] Outflow end layer connection area 122 skirt bracket 3

[0048] The third protrusion 123 DETAILED DESCRIPTION

[0049] The utility model is described in detail below in conjunction with specific embodiments. The following embodiments will help those skilled in the art to further understand the utility model, but do not limit the utility model in any form. It should be pointed out that for those of ordinary skill in the art, several changes and improvements can be made without departing from the concept of the utility model. These all belong to the protection scope of the utility model.

[0050] Example 1

[0051] like Figure 1-6 As shown, the utility model includes an inner frame with barbs for mitral valve replacement, which includes an inflow end layer 11 and an outflow end layer 12. The inflow end layer 11 and the outflow end layer 12 are sequentially arranged on the inner frame 1, and the inflow end layer 11 is arranged on one layer of the inner frame 1, and the outflow end layer 12 is arranged on another layer of the inner frame 1. The inflow end layer 11 and the outflow end layer 12 include frame units and connection areas, and the connection areas are arranged on both sides of the frame units. Barbs 14 are arranged on multiple connection areas of the inflow end layer 11, and barbs 14 are arranged in multiple frame units of the outflow end layer 12. The inner frame 1 pierces the leaflets of the native valve through the multiple barbs 14 on the inflow end layer 11 and the multiple barbs 14 on the outflow end layer 12, so that the artificial heart valve using the inner frame 1 is more firmly anchored to the native valve.

[0052] The inflow end layer 11 includes a plurality of inflow end layer frame units 111 and a plurality of inflow end layer connection areas 112, and the plurality of inflow end layer frame units 111 are connected to each other. The plurality of inflow end layer frame units 111 adopt hollow gyro-shaped inflow end layer frame units 111, and a single inflow end layer connection area 112 is set as an area where two adjacent inflow end layer frame units 111 are connected to each other. The outflow end layer 12 includes a plurality of outflow end layer frame units 121 and a plurality of outflow end layer connection areas 122, and the plurality of outflow end layer frame units 121 are connected to each other. The plurality of outflow end layer frame units 121 adopt hollow gyro-shaped outflow end layer frame units 121, and a single outflow end layer connection area 122 is set as an area where two adjacent outflow end layer frame units 121 are connected to each other. The inflow end layer frame unit 111 includes a first protrusion 113 and a second protrusion 114. The first protrusion 113 is protruded toward one end along the vertical axis direction of the inflow end layer frame unit 111, and the second protrusion 114 is protruded toward the other end along the vertical axis direction of the inflow end layer frame unit 111. The protrusion direction of the first protrusion 113 is opposite to that of the second protrusion 114, and a connecting arm 13 is centrally arranged inside the second protrusion 114. The inflow end layer frame unit 111 also includes a first connecting portion 115 and a second connecting portion 116. The first connecting portion 115 is arranged between the first protrusion 113 and the inflow end layer connection area 112, and the second connecting portion 116 is arranged between the second protrusion 114 and the inflow end layer connection area 112. A barb 14 is centrally arranged on the inflow end layer connection area 112 between two adjacent inflow end layer frame units 111. A terminal 131 is provided at one end of the connecting arm 13, and a plurality of connecting holes 132 are provided on the terminal 131. The outflow end layer frame unit 121 includes a third protrusion 123 and a fourth protrusion 124. The third protrusion 123 is provided to protrude toward one end along the vertical axis direction of the outflow end layer frame unit 121, and the fourth protrusion 124 is provided to protrude toward the other end along the vertical axis direction of the outflow end layer frame unit 121. The protrusion direction of the third protrusion 123 is opposite to that of the fourth protrusion 124, and a barb 14 is provided in the center of the inner side of the fourth protrusion 124. The outflow end layer frame unit 121 also includes a third connecting portion 126 and a fourth connecting portion 127. The third connecting portion 126 is provided between the third protrusion 123 and the outflow end layer connecting area 122, and the fourth connecting portion 127 is provided between the fourth protrusion 124 and the outflow end layer connecting area 122. The fourth protrusion 124 is connected to the suture part 125 on the outside, and the suture part 125 is provided with a suture hole 1251, and the fourth protrusion 124 and the suture part 125 adopt an integrated connection structure. The first protrusion 113 adopts a large "J"-shaped first protrusion, and the second protrusion 114 adopts a large "J"-shaped second protrusion. The third protrusion 123 adopts a small "J"-shaped third protrusion, and the fourth protrusion 124 adopts a small "J"-shaped fourth protrusion. The bending angles of the connecting arm 13 and the barb 14 are both set at 10° to 45°.

[0053] Specifically, in this embodiment, the barbed inner frame of the utility model for mitral valve replacement is made of nickel-titanium alloy as a whole, and the inner frame of the utility model is cut out by laser cutting on the nickel-titanium alloy tube to form an integral body.

[0054] Specifically, in this embodiment, the barbed inner frame of the utility model for mitral valve replacement adopts an annular structure as a whole.

[0055] Specifically, in this embodiment, the barbed inner frame for mitral valve replacement of the utility model is connected to the skirt support 3 by suture thread through its connecting arm 13 .

[0056] Specifically, in this embodiment, the connecting arm 13 of the barbed inner frame for mitral valve replacement of the utility model adopts an arc-shaped connecting arm, the end 131 adopts an 8-shaped end, the connecting hole 132 adopts a circular connecting hole, and the connecting hole 132 is a suture hole for passing the suture thread.

[0057] Specifically, in this embodiment, the frame units on the inflow end layer 11 and the outflow end layer 12 of the barbed inner frame of the utility model for mitral valve replacement adopt a hollow design structure, which can improve hemodynamic disorders and reduce the probability of valve thrombosis after implantation.

[0058] Specifically, in this embodiment, a heart valve stent includes the above-mentioned barbed inner frame 1 for mitral valve replacement, and also includes a skirt stent 2 and a valve positioning piece 3. The barbed inner frame 1, the skirt stent 2 and the valve positioning piece 3 can all be wrapped with a coating, which can further reduce the probability of damaging physiological tissues in the heart (such as chordae tendineae and papillary muscles) during the intervention process.

[0059] Working principle:

[0060] The utility model provides barbs on multiple connection areas of the inflow end layer and also provides barbs in multiple frame units of the outflow end layer. During the intervention of mitral valve replacement surgery, the mitral valve artificial heart valve of the utility model inner frame is used. The multiple barbs on the inflow end layer of the utility model inner frame and the multiple barbs on the outflow end layer are inserted into the leaflets of the native mitral valve, so that the mitral valve artificial heart valve and the native mitral valve are more firmly anchored, and the displacement of the mitral valve artificial heart valve under the impact of blood flow in the heart is prevented, so that the operation is smoothly carried out and the success rate of the operation is improved. At the same time, the utility model adopts a radial interference structure through the inner frame, and the diameter of the inner frame is designed to be larger than the diameter of the valve ring on the native mitral valve, so that the barbs on the inner frame are convenient to be inserted into the valve ring of the native mitral valve to play an anchoring and strengthening role.

[0061] In the description of the present application, it should be understood that the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0062] The above describes the specific embodiments of the present invention. It should be understood that the present invention is not limited to the above specific embodiments, and those skilled in the art can make various changes or modifications within the scope of the claims, which does not affect the essence of the present invention. In the absence of conflict, the embodiments of the present application and the features in the embodiments can be combined with each other at will.

Claims

1. A barbed inner frame for mitral valve replacement, characterized in that: The inner frame (1) comprises an inflow end layer (11) and an outflow end layer (12); The inflow end layer (11) and the outflow end layer (12) are sequentially arranged on the inner frame (1), and the inflow end layer (11) is arranged on one layer of the inner frame (1), and the outflow end layer (12) is arranged on another layer of the inner frame (1); The inflow end layer (11) and the outflow end layer (12) include a frame unit and a connection area, and the connection area is arranged on both sides of the frame unit; The plurality of connection areas of the inflow end layer (11) are provided with barbs (14), and the plurality of frame units of the outflow end layer (12) are provided with barbs (14); The inner frame (1) pierces the leaflets of the native valve through the multiple barbs (14) on the inflow end layer (11) and the multiple barbs (14) on the outflow end layer (12).

2. The barbed inner frame for mitral valve replacement according to claim 1, characterized in that: The inflow end layer (11) comprises a plurality of inflow end layer frame units (111) and a plurality of inflow end layer connection areas (112), and the plurality of inflow end layer frame units (111) are connected to each other; The plurality of inflow end layer frame units (111) include hollow gyro-shaped inflow end layer frame units (111), and a single inflow end layer connection area (112) is configured as an area where two adjacent inflow end layer frame units (111) are connected to each other.

3. The barbed inner frame for mitral valve replacement according to claim 2, characterized in that: The outflow end layer (12) comprises a plurality of outflow end layer frame units (121) and a plurality of outflow end layer connection areas (122), and the plurality of outflow end layer frame units (121) are connected to each other; The plurality of outflow end layer frame units (121) include hollow gyro-shaped outflow end layer frame units (121), and a single outflow end layer connection area (122) is configured as an area where two adjacent outflow end layer frame units (121) are connected to each other.

4. The barbed inner frame for mitral valve replacement according to claim 3, characterized in that: The inflow end layer frame unit (111) comprises a first protrusion (113) and a second protrusion (114), wherein the first protrusion (113) is arranged to protrude toward one end along the vertical axis direction of the inflow end layer frame unit (111), and the second protrusion (114) is arranged to protrude toward the other end along the vertical axis direction of the inflow end layer frame unit (111), the protrusion direction of the first protrusion (113) is opposite to the protrusion direction of the second protrusion (114), and a connecting arm (13) is arranged in the center of the inner side of the second protrusion (114); The inflow end layer frame unit (111) further comprises a first connection portion (115) and a second connection portion (116), wherein the first connection portion (115) is arranged between the first protrusion (113) and the inflow end layer connection area (112), and the second connection portion (116) is arranged between the second protrusion (114) and the inflow end layer connection area (112); The barb (14) is centrally arranged on the inlet end layer connection area (112) between two adjacent inlet end layer frame units (111).

5. The barbed inner frame for mitral valve replacement according to claim 4, characterized in that: An end (131) is provided on one end of the connecting arm (13), and a plurality of connecting holes (132) are provided on the end (131).

6. The barbed inner frame for mitral valve replacement according to claim 5, characterized in that: The outflow end layer frame unit (121) comprises a third protrusion (123) and a fourth protrusion (124); the third protrusion (123) is arranged to protrude toward one end along the vertical axis direction of the outflow end layer frame unit (121); the fourth protrusion (124) is arranged to protrude toward the other end along the vertical axis direction of the outflow end layer frame unit (121); the protrusion direction of the third protrusion (123) is opposite to the protrusion direction of the fourth protrusion (124); and the barb (14) is arranged in the center of the inner side of the fourth protrusion (124); The outflow end layer frame unit (121) also includes a third connecting portion (126) and a fourth connecting portion (127), wherein the third connecting portion (126) is arranged between the third protruding portion (123) and the outflow end layer connecting area (122), and the fourth connecting portion (127) is arranged between the fourth protruding portion (124) and the outflow end layer connecting area (122).

7. The barbed inner frame for mitral valve replacement according to claim 6, characterized in that: The outer side of the fourth protruding portion (124) is connected to the sewing portion (125), a sewing hole (1251) is provided on the sewing portion (125), and the fourth protruding portion (124) and the sewing portion (125) adopt an integrated connection structure.

8. The barbed inner frame for mitral valve replacement according to claim 7, characterized in that: The first protrusion (113) comprises a first protrusion in the shape of a large Chinese character "X", and the second protrusion (114) comprises a second protrusion in the shape of a large Chinese character "X"; The third protrusion (123) comprises a third protrusion in the shape of a small “X”, and the fourth protrusion (124) comprises a fourth protrusion in the shape of a small “X”.

9. The barbed inner frame for mitral valve replacement according to claim 8, characterized in that: The bending angles of the connecting arm (13) and the barb (14) are both set at 10° to 45°.

10. A heart valve stent, characterized in that: It comprises the barbed inner frame for mitral valve replacement as described in any one of claims 1-9.

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