Heart valve replacement device, system and method of artificial valve anchoring

Abstract

The present application provides a heart valve replacement device, system and artificial valve anchoring method, the heart valve replacement device comprises a ring-shaped support, a leaflet structure arranged on the inner surface of the ring-shaped support along the circumferential direction of the ring-shaped support, a first clamping member and a second clamping member arranged on the outer surface of the ring-shaped support along the axial direction of the ring-shaped support, wherein the ring-shaped support can be radially contracted or expanded, and the first clamping member and the second clamping member can cooperatively clamp the native leaflet of the heart, so that the leaflet structure is positioned relative to the native valve of the heart. Therefore, the present application can provide better artificial valve positioning effect, so as to improve the success rate of valve replacement surgery.

Description

TECHNICAL FIELD

[0001] The embodiment of the present application relates to the technical field of medical devices, in particular to a heart valve replacement device, a system and an artificial valve anchoring method. BACKGROUND

[0002] The mitral valve, also known as the left atrioventricular valve, is a barrier formed between the left ventricle and the left atrium. Normally, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and the left ventricle. During diastole, the left atrial pressure is greater than the left ventricular pressure, and the mitral valve opens. Conversely, during systole, the left ventricular pressure is greater than the left atrial pressure, and the mitral valve closes. The mitral valve structure is complex, consisting of an annulus, leaflets, chordae tendineae, and papillary muscles. Any part of the structure that undergoes organic or functional changes can cause mitral regurgitation, i.e., the mitral valve cannot completely close during systole, causing blood from the left ventricle to flow back into the left atrium. Treatment methods for mitral regurgitation include valve repair and replacement, with valve repair being the common first choice of treatment, but valve replacement is the ultimate solution.

[0003] Heart valve replacement can be performed surgically or by catheter intervention. For patients with mitral regurgitation who have low cardiac function, multiple comorbidities, advanced age, and other high-risk factors, and are not suitable for surgical operation, they can receive catheter intervention treatment.

[0004] Currently, transcatheter aortic valve replacement is a very mature treatment for aortic valve disease, and there are several transcatheter aortic valve products on the market. However, for transcatheter mitral valve replacement, although various structural designs and delivery methods have emerged in recent years, most are still in the research stage, and the following factors are limiting: First, due to the complex structure of the mitral valve, compared with the aortic valve, the overall structure of the mitral valve is D-shaped, the annulus size is larger, and there is less calcification, which cannot provide enough support for the artificial valve to fix it at the diseased mitral valve. Second, in terms of anatomical structure, the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral valve, and the implantation of the artificial mitral valve may also cause left ventricular outflow tract obstruction (LVOTO), which also needs to be considered when designing the artificial valve. In addition, due to the larger size of the mitral valve annulus, if the artificial valve is a single-layer stent, compared with the aortic valve, a larger diameter stent is needed, which will result in an increase in the corresponding valve leaflet area of the artificial valve, reduce the fatigue resistance of the valve leaflet, and increase the size of the delivery system, causing an increased risk of vascular complications.

[0005] Therefore, there is an urgent need for a heart valve replacement product that can improve the positioning effect of the artificial valve and increase the success rate of valve replacement surgery. SUMMARY

[0006] In view of the above problems, the present application provides a heart valve replacement device, system and artificial valve anchoring method to overcome the above problems or at least partially solve the above problems.

[0007] According to a first aspect of the present application, a heart valve replacement device is provided, comprising a ring-shaped support having oppositely arranged inner and outer surfaces; a leaflet structure comprising a plurality of artificial valve leaflets arranged along a circumferential direction of the ring-shaped support on the inner surface of the ring-shaped support; a first clamping member and a second clamping member arranged along an axial direction of the ring-shaped support on the outer surface of the ring-shaped support; wherein the ring-shaped support is radially contractible or expandable, and the first clamping member and the second clamping member can cooperatively clamp native valve leaflets of a heart, so that the leaflet structure is positioned relative to a native valve of the heart.

[0008] Optionally, the ring-shaped support comprises a support ring having a plurality of deformable mesh cells; and a main covering film attached to an inner side of the support ring or to both the inner side and the outer side of the support ring.

[0009] Optionally, the plurality of deformable mesh cells comprises at least one of quadrilateral mesh cells and hexagonal mesh cells; and wherein deformable mesh cells having the same shape can be arranged in rows and / or arranged in columns.

[0010] Optionally, the ring-shaped support comprises an inflow end and an outflow end oppositely arranged along an axial direction thereof; wherein the first clamping member is arranged on the ring-shaped support proximate to one side of the outflow end, and the second clamping member is arranged on the ring-shaped support proximate to one side of the inflow end; the first clamping member comprises a plurality of first clamping units circumferentially surrounding the outer surface of the ring-shaped support; and the second clamping member comprises a plurality of second clamping units circumferentially surrounding the outer surface of the ring-shaped support.

[0011] Optionally, each first clamping unit extends radially outwardly from the outer surface of the ring-shaped support in a direction towards the inflow end of the ring-shaped support; and each second clamping unit extends radially outwardly from the outer surface of the ring-shaped support in a direction towards the inflow end or the outflow end of the ring-shaped support.

[0012] Optionally, each of the first clamping units and the second clamping units comprises a fixed end connected to the annular support, a free end opposite to the fixed end, and a middle section between the fixed end and the free end, and the device further comprises a driving part, wherein the driving part is arranged at the free end of each of the first clamping units and the second clamping units; and / or the driving part is arranged at the middle section of each of the first clamping units and the second clamping units; and wherein the driving part is connected to a driving member, and the driving member controls the elastic deformation of each of the first clamping units and the second clamping units to adjust the opening and closing angle of each of the first clamping units and the second clamping units relative to the annular support.

[0013] Optionally, the device further comprises a reinforcing unit arranged on at least one of the first clamping units and the second clamping units.

[0014] Optionally, the device further comprises an anchoring unit arranged on at least one of the first clamping units and the second clamping units.

[0015] Optionally, along the axial direction of the annular support, each of the first clamping units of the first clamping member and each of the second clamping units of the second clamping member are arranged in alignment or in staggered arrangement.

[0016] Optionally, the first clamping unit or the second clamping unit comprises one of a clamping sheet and a clamping rod; wherein, in the case that the first clamping unit or the second clamping unit comprises the clamping sheet, the first clamping unit or the second clamping unit is in any one of a V shape, a U shape, and an M shape; and in the case that the first clamping unit or the second clamping unit comprises the clamping rod, the first clamping unit or the second clamping unit is in any one of a J shape and an S shape.

[0017] Optionally, the device further comprises a connecting structure arranged at the inflow end of the annular support and detachably connected to an external device.

[0018] Optionally, the distance between the first clamping member and the second clamping member is between 1 mm and 10 mm.

[0019] Optionally, the device further comprises a clamping film arranged on at least one of the first clamping member and the second clamping member.

[0020] According to a second aspect of the present application, a heart valve replacement system is provided, comprising: the heart valve replacement device according to the first aspect; and a positioning device positioned between the first clamping member and the second clamping member of the heart valve replacement device and positioned at a specified position of a heart, so as to fix the heart valve replacement device relative to a native valve of the heart.

[0021] According to a third aspect of the present application, a method for anchoring a prosthetic valve is provided, which is applied to the heart valve replacement device of the first aspect, and the method comprises: delivering the heart valve replacement device into a heart by using a delivery system; releasing a first clamping member of the heart valve replacement device, so that native valve leaflets of the heart are located between the first clamping member and a second clamping member of the heart valve replacement device; controlling the heart valve replacement device to move relative to the heart, so that the native valve leaflets are folded between the first clamping member and an annular support of the heart valve replacement device; releasing the second clamping member of the heart valve replacement device, so that the first clamping member and the second clamping member cooperate to clamp the native valve leaflets, and the heart valve replacement device is positioned relative to the native valve of the heart.

[0022] According to a fourth aspect of the present application, a method for anchoring a prosthetic valve is provided, which is applied to the heart valve replacement system of the second aspect, and the method comprises: delivering a positioning device of the heart valve replacement system into a heart by using a delivery system, so that the positioning device is positioned at a specified position of the heart, and each native valve leaflet of the heart is gathered in the positioning device; delivering the heart valve replacement device into the inside of the positioning device by using the delivery system, and releasing a first clamping member and a second clamping member of the heart valve replacement device in sequence, so that each native valve leaflet of the heart is clamped between the first clamping member, the second clamping member of the heart valve replacement device and the positioning device, so that the heart valve replacement system is positioned relative to the native valve of the heart.

[0023] In summary, the heart valve replacement device provided by the embodiments of the present application clamps the native valve leaflets of the heart by the cooperation of the first clamping member and the second clamping member, so that the valve leaflet structure is positioned relative to the native valve of the heart, which can improve the anchoring effect of the heart valve replacement device.

[0024] In addition, the heart valve replacement device provided by the embodiments of the present application can achieve good sealing effect by folding and stacking the native valve leaflets of the heart between the first clamping member and the second clamping member, which can effectively prevent the problem of heart blood reflux.

[0025] Furthermore, the heart valve replacement system provided by the embodiments of the present application can place the heart valve replacement device in the positioning device, so as to effectively enhance the anchoring force and sealing effect of the native valve leaflets of the heart valve replacement device by the radial interaction force between the positioning device and the heart valve replacement device. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0027] Figures 1-3 Schematic diagram of the overall structure of the heart valve replacement device according to different embodiments of the present application.

[0028] Figures 4A-4E Schematic diagram of the structure of the annular support member according to different embodiments of the present application.

[0029] Figure 5 and Figure 6 Schematic diagrams of the structures of the first clamping member and the second clamping member according to different embodiments of the present application.

[0030] Figures 7A-7C Schematic diagrams of the structures of the first clamping unit and the second clamping unit according to different embodiments of the present application.

[0031] Figure 8 This is a schematic diagram of the application of a heart valve replacement device according to an exemplary embodiment of the present application.

[0032] Figure 9 This is a schematic diagram of an application of a heart valve replacement system according to an exemplary embodiment of the present application.

[0033] Figures 10A-10B This is a schematic diagram of an implementation of a prosthetic valve anchoring method according to an exemplary embodiment of the present application.

[0034] Component number

[0035] 10: Heart valve replacement device;

[0036] 102: annular support member;

[0037] 102a: inner surface;

[0038] 102b: outer surface;

[0039] 104: Leaflet structure;

[0040] 105: artificial valve leaflet;

[0041] 106: first clamping member;

[0042] 108: second clamping member;

[0043] 110: support ring;

[0044] 112: deformable mesh element;

[0045] 112a: Quadrilateral mesh cell;

[0046] 112b: Hexagonal mesh cell;

[0047] 114: Body covering;

[0048] 116: Inflow end;

[0049] 118: Outflow end;

[0050] 120: First clamping unit;

[0051] 122: Second clamping unit;

[0052] 124: Fixed end;

[0053] 126: Free end;

[0054] 128: Mid-section portion;

[0055] 129a / 129b: Drive portion;

[0056] 1291: Through hole;

[0057] 130: Reinforcing unit;

[0058] 132: Anchoring unit;

[0059] 134: Clamping covering;

[0060] 136: Connection structure;

[0061] 20: Positioning device;

[0062] 30: Heart;

[0063] 32: Native leaflet;

[0064] 34: Native annulus;

[0065] 4: Delivery system;

[0066] 42: Delivery outer sheath;

[0067] 44: Delivery inner sheath. DETAILED DESCRIPTION

[0068] In order for those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all embodiments. Based on the embodiments in the embodiments of the present application, all other embodiments obtained by those skilled in the art should belong to the scope of protection of the embodiments of the present application.

[0069] At present, most of the transcatheter mitral valve replacement products include a crown structure, for example, the valve replacement structures disclosed in patents Nos. CN114288069A, CN114305805A and CN114305806A all contain a crown used to fix the valve skirt, and the crown plays a role in positioning and sealing, but the presence of the crown can cause risks of thrombosis, hemolysis, and incomplete endothelialization, and if the crown does not fit in place with the native valve annulus of the heart, it can cause the overall replacement valve to tilt and cause paravalvular leakage.

[0070] Therefore, the embodiments of the present application provide a heart valve replacement device with improved structure to solve the technical problems existing in the prior art.

[0071] The specific implementation of the embodiments of the present application will be further described below with reference to the accompanying drawings of the embodiments of the present application.

[0072] Figures 1-3 A perspective view of a heart valve replacement device 10 according to different embodiments of the present application is shown in the figure. As shown in the figure, the heart valve replacement device 10 according to the present embodiment mainly includes an annular support 102, a leaflet structure 104, a first clamping member 106 and a second clamping member 108.

[0073] The annular support 102 has an inner surface 102a and an outer surface 102b (see Figure 5 and Figure 6 ) arranged oppositely.

[0074] In the present embodiment, the annular support 102 can be radially contracted or expanded.

[0075] Specifically, by controlling the annular support 102 to be radially contracted, the heart valve replacement device 10 can be accommodated in a delivery catheter to perform a delivery operation, and after the heart valve replacement device 10 is delivered to a designated position in the heart via the catheter, the annular support 102 can be controlled to be radially expanded to achieve positioning of the heart valve replacement device 10 in the heart.

[0076] Optionally, the annular support 102 can include a support ring 110 and a main body covering film 114.

[0077] Referring to Figures 4A-4D , the support ring 110 has a plurality of deformable mesh units 112.

[0078] Optionally, the deformable mesh units 112 include at least one of a quadrilateral mesh unit 112a and a hexagonal mesh unit 112b, and deformable mesh units 112 of the same shape can be arranged in rows and / or columns.

[0079] In one embodiment, when each of the deformable mesh units 112 constituting the annular support member 102 is a quadrilateral mesh unit 112a (see Figure 4C ), or when all the deformable mesh units 112 constituting the annular support member 102 are hexagonal mesh units 112b (not shown), along the radial direction of the annular support member 102, the deformable mesh units 112 having the same shape may be arranged in rows and in columns.

[0080] In another embodiment, when each deformable grid unit constituting the annular support member 102 includes both quadrilateral grid units 112a and hexagonal grid units 112b (see Figure 4A 、 Figure 4B ), along the radial direction of the annular support member 102, the deformable grid units 112 having the same shape may be arranged in rows.

[0081] The main body coating 114 can be attached to the inner side of the support ring 110 (refer to Figure 1 ), or the main body coating 114 can also be attached to the inner side and the outer side of the support ring 110 at the same time (refer to Figure 2 embodiment shown).

[0082] In this embodiment, the main body coating 114 may be made of a polymer coating with good biocompatibility to provide a sealing effect to prevent blood from flowing back.

[0083] The leaflet structure 104 includes a plurality of artificial leaflets 105 provided on the inner surface 102a of the annular support member 102 along the circumference of the annular support member 102. Figure 5 and Figure 6 In the illustrated embodiment, the leaflet structure 104 includes three artificial leaflets 105 distributed on the inner surface 102 a of the annular support member 102 along the circumference of the annular support member 102 .

[0084] The first clamping member 106 and the second clamping member 108 are provided on the outer surface 102b of the annular support member 102 along the axial direction of the annular support member 102. The first clamping member 106 and the second clamping member 108 can cooperate to clamp the native valve leaflets 32 of the heart 30 so that the leaflet structure 104 is positioned relative to the native valve of the heart 30.

[0085] Optionally, the spacing distance between the first clamping member 106 and the second clamping member 108 may be between 1 mm and 10 mm.

[0086] In this embodiment, the native valve leaflets 32 of the heart 30 can be folded and stacked between the first clamping member 106 and the second clamping member 108 (refer to Figure 8 ) to achieve a good sealing effect.

[0087] In the present embodiment, the annular support 102 comprises an inflow end 116 and an outflow end 118 (see Fig. 1) disposed axially opposite to each other. Figures 1-4E

[0088] Specifically, the first clamping member 106 is disposed on the annular support 102 close to one side of the outflow end 118, and the second clamping member 108 is disposed on the annular support 102 close to one side of the inflow end 116.

[0089] Optionally, the first clamping member 106 comprises a plurality of first clamping units 120 circumferentially surrounding the outer surface 102b of the annular support 102, and the second clamping member 108 comprises a plurality of second clamping units 122 circumferentially surrounding the outer surface 102b of the annular support 102 (see Fig. 1). Figures 2-6

[0090] In the present embodiment, each of the first clamping units 120 and the second clamping units 122 comprises a fixed end 124 connected to the annular support 102, a free end 126 opposite to the fixed end 124, and a middle section 128 between the fixed end 124 and the free end 126 (see Fig. 1). Figure 5

[0091] Optionally, each of the first clamping units 120 of the first clamping member 106 can extend radially outwardly from the outer surface 102b of the annular support 102 towards the inflow end 116 of the annular support 102 (see Fig. 1). Figures 1-3

[0092] Optionally, each of the second clamping units 122 of the second clamping member 108 can extend radially outwardly from the outer surface 102b of the annular support 102 towards the inflow end 116 of the annular support 102 (see Fig. 1). Figures 1-3 Figure 4A In this case, the extending direction of each of the first clamping units 120 and the second clamping units 122 is the same, i.e., each of the first clamping units 120 and the second clamping units 122 extends obliquely towards the inflow end 116 of the annular support 102. This design can be used in cooperation with an additional structure (e.g., a positioning device 20 described below) to improve the positioning effect of the heart valve replacement device 10.

[0093] Optionally, each of the second clamping units 122 of the second clamping member 108 can extend radially outwardly from the outer surface 102b of the annular support 102 towards the outflow end 118 of the annular support 102 (see Fig. 1). Figure 4B Figure 4C ​​​​​​). In this case, the extension directions of the first clamping units 120 and the second clamping units 122 are opposite, that is, the first clamping units 120 close to the outflow end 118 extend obliquely towards the inflow end 116 of the annular support 102, and the second clamping units 122 close to the inflow end 116 extend obliquely towards the outflow end 118 of the annular support 102. This design can prevent the native leaflets 32 from being easily detached from between the first clamping members 106 (the first clamping units 120) and the second clamping members (the second clamping units 122), reduce the risk of the heart valve replacement device 10 slipping off the native leaflets 32, and enhance the anchoring force of the annular support 102.

[0094] Optionally, the heart valve replacement device 10 further comprises a driving portion 129a / 129b (refer to Figure 7A ) which can be arranged at the free end 126 of each of the first clamping units 120 and the second clamping units 122, and / or arranged at the middle section 128 of each of the first clamping units 120 and the second clamping units 122.

[0095] The driving portion 129a / 129b can be connected to a driving member (such as a traction wire) and can be controlled by the driving force of the driving member to control the elastic deformation of each of the first clamping units 120 and the second clamping units 122, so as to adjust the opening angle of each of the first clamping units 120 and the second clamping units 122 relative to the annular support 102.

[0096] In the embodiment, the driving portion 129a / 129b can extend from the first clamping unit 120 or the second clamping unit 122 and has a through hole 1291 (refer to Figure 7A ).

[0097] The driving member (such as a traction wire) can be arranged in the through hole 1291 of the driving portion 129a or 129b, so that the driving portion 129a or 129b can be controlled by the driving force of the driving member to control the elastic deformation of each of the first clamping units 120 or the second clamping units 122, so as to adjust the opening angle of each of the first clamping units 120 and the second clamping units 122 relative to the annular support 102.

[0098] In the embodiment, the driving portion 129 can be I-shaped or Y-shaped. When the driving portion 129 is I-shaped (refer to 129a of Figure 7A ), the first end of the driving portion 129a is connected to the free end 126 of the first clamping unit 120 or the second clamping unit 122, and the through hole 1291 is arranged at the second end of the driving portion 129a relative to the first end. When the driving portion 129 is Y-shaped (refer to 129b of Figure 7AThe two ends of the driving portion 129b are respectively connected to opposite sides of the terminal portion 128 of the first clamping unit 120 or the second clamping unit 122.

[0099] In other embodiments, the driving portion 129a or 129b can only include the through hole 1291 and can be provided at the free end 126 and / or the middle portion 128 of the first clamping unit 120 or the second clamping unit 122 for the driving portion (see Figure 7B ).

[0100] It should be noted that the connection mode and connection position between the driving portion and the first clamping unit 120 or the second clamping unit 122 are not limited to the above-described embodiments, and can be adjusted as required by those skilled in the art, which is not limited in the present application.

[0101] Optionally, the heart valve replacement device 10 further comprises a reinforcing unit 130 provided on at least one of the first clamping unit 120 and the second clamping unit 122.

[0102] For example, in the embodiment shown in Figure 7C , the reinforcing unit 130 can be provided on the middle portion 128 of the first clamping unit 120 or the second clamping unit 122 to reinforce the structural strength of the first clamping unit 120 or the second clamping unit 122.

[0103] It should be noted that the structure of the reinforcing unit 130 is not limited to the V-shaped structure shown in Figure 7C , and the position of the reinforcing unit 130 provided on the first clamping unit 120 or the second clamping unit 122 is also not limited to the middle portion 128 shown in Figure 7C , and can be adjusted as required by those skilled in the art, which is not limited in the present application.

[0104] Optionally, the heart valve replacement device 10 further comprises an anchoring unit 132 provided on at least one of the first clamping unit 120 and the second clamping unit 122.

[0105] In the present embodiment, the anchoring unit 132 can be a barb provided on the free end 126 of the first clamping unit 120 or the second clamping unit 122 (see Figure 4D or Figure 4E ), for increasing the anchoring force of the first clamping unit 120 or the second clamping unit 122 to the native leaflet 32, so that the native leaflet 32 can be firmly clamped between the first clamping member 106 (the first clamping unit 120) and the second clamping member 108 (the second clamping unit 122) without being easily slipped off.

[0106] Preferably, the tips of the barbs (anchoring units 132) provided on the second clamping units 122 can extend towards the outflow end 118 of the annular support 102, so that after the second clamping units 122 are released, the tips of the barbs (anchoring units 132) provided thereon can be inserted into the native leaflet 32, thereby increasing the anchoring force of the second clamping units 122 on the native leaflet 32.

[0107] It should be noted that the structure of the anchoring units 132 is not limited to barbs, and the anchoring units 132 can also be provided on the middle section 128 of the first clamping units 120 or the second clamping units 122. Those skilled in the art can make any adjustment according to actual needs, and the present application does not limit this.

[0108] Optionally, along the axial direction of the annular support 102, the first clamping units 120 of the first clamping member 106 and the second clamping units 122 of the second clamping member 108 can be arranged in alignment (see Figure 5 ) or in staggered arrangement (see Figure 6 ).

[0109] Optionally, the first clamping units 120 or the second clamping units 122 can be clamping pieces or clamping rods.

[0110] In the present embodiment, when the first clamping units 120 or the second clamping units 122 comprise clamping pieces (see Figures 4A-4C , Figure 4E ), the first clamping units 120 or the second clamping units 122 can be V-shaped, U-shaped, M-shaped, etc.

[0111] In the present embodiment, when the first clamping units 120 or the second clamping units 122 comprise clamping rods (see Figure 4D ), the first clamping units 120 or the second clamping units 122 can be J-shaped, S-shaped, etc.

[0112] Optionally, the heart valve replacement device 10 further comprises a clamping covering 134 provided on at least one of the first clamping member 106 and the second clamping member 108 (see Figures 1-3 ).

[0113] Specifically, in the embodiments shown in Figure 1 and Figure 2 , the clamping covering 134 is attached to the surface of both the first clamping member 106 and the second clamping member 108; in the embodiment shown in Figure 3 , the clamping covering 134 is attached only to the surface of the first clamping member 106.

[0114] In the present embodiment, the clamping covering 134 can comprise a high-molecular covering with good biocompatibility.

[0115] Optionally, the heart valve replacement device 10 further comprises a connecting structure 136 disposed at the inflow end 116 of the annular support 102 and configured to detachably connect to an external device (not shown) Figures 4A-4E ).

[0116] For example, the connecting structure 136 can be configured to connect the heart valve replacement device 10 to a fixation member (not shown) on a delivery system to ensure that the heart valve replacement device 10 does not shift during delivery.

[0117] The following will briefly describe the artificial valve anchoring method of the heart valve replacement device 10 according to the present application, which mainly comprises the following steps: Figure 8 , Figure 10A , Figure 10B .

[0118] Deliver the heart valve replacement device 10 into the heart 30 by using the delivery system 4.

[0119] In the present embodiment, the delivery system 4 comprises a delivery outer sheath 42 and a delivery inner sheath 44, wherein the delivery inner sheath is provided with a fixation member configured to connect to the connecting structure 136 on the annular support 102 of the heart valve replacement device 10 to avoid the heart valve replacement device from shifting during delivery and release.

[0120] Release the first clamping member 106 of the heart valve replacement device 10 so that the native valve leaflet 32 of the heart 30 is located between the first clamping member 106 and the second clamping member 108 of the heart valve replacement device 10 (see Figure 10A and Figure 10B ).

[0121] In the present embodiment, the first clamping member 106 and the second clamping member 108 of the heart valve replacement device 10 can be connected to a driving member (e.g. a pulling wire) by the driving portions 129a / 129b, and the driving member is connected to the end of the delivery inner sheath, so that the driving member can be used to apply a force to the first clamping member 106 and the second clamping member 108 to adjust the opening and closing angle of each first clamping unit 120 in the first clamping member 106 and each second clamping unit 122 in the second clamping member 108 relative to the annular support 102.

[0122] Specifically, the first clamping member 106 near the outflow end 118 can be released by the driving member (e.g. a pulling wire), while the distance between the end of the delivery inner sheath of the delivery system 4 and the outflow end of the annular support 102 is increased, so that the opening angle of the first clamping member 106 is increased, thereby facilitating the capture of the free edge of the native valve leaflet 32 between the first clamping member 106 and the annular support 102.

[0123] The heart valve replacement device 10 is controlled to move relative to the heart 30 so that the native valve leaflets 32 are folded between the first clamping body and the annular support 102 of the heart valve replacement device 10 .

[0124] Specifically, the heart valve replacement device 10 can be pulled upward as a whole, so that the native valve leaflets 32 are folded in the space between the first clamping member 106 and the annular support member 102 .

[0125] The second clamp 108 of the heart valve replacement device 10 is released, so that the first clamp 106 and the second clamp 108 cooperate to clamp the native valve leaflets 32 and position the heart valve replacement device 10 relative to the native valve of the heart 30 .

[0126] Specifically, the second clamping member 108 near the inflow end 116 can be released via a driving member (such as a traction line) so that the second clamping member 108 returns to its original open state, thereby clamping the folded native leaflet 32 ​​between the first clamping member 106 and the second clamping member 108, thereby achieving fixation of the annular support member 102 at the native leaflet 32.

[0127] Optionally, the annular support member 102 of the heart valve replacement device 10 can be released at the same time as the second clamping member 108 of the heart valve replacement device 10 is released to cause it to expand radially; or, the annular support member 102 of the heart valve replacement device 10 can be released after the second clamping member 108 of the heart valve replacement device 10 is released to cause it to expand radially.

[0128] Thus, the artificial valve anchoring method for the heart valve replacement device 10 provided in this embodiment can clamp the folded native leaflets between the first clamping member and the second clamping member to form a sandwich clamping effect, so as to achieve the fixation of the annular support member on the native leaflets, and achieve a good sealing effect through the folding and stacking of the native leaflets and the coating on the support ring, the first clamping member, and the second clamping member.

[0129] Another embodiment of the present application provides a heart valve replacement system, which includes a heart valve replacement device 10 and a positioning device 20 (refer to Figure 9 ).

[0130] The structural design of the heart valve replacement device 10 can refer to the above Figures 1-8 The description of the illustrated embodiment will not be repeated here.

[0131] The positioning device 20 can be positioned between the first clamping member 106 and the second clamping member 108 of the heart valve replacement device 10 and positioned at a designated position of the heart 30 to fix the heart valve replacement device 10 relative to the native valve of the heart 30 .

[0132] Optionally, the positioning device 20 can include a ventricular portion positioned in the ventricle, or the positioning device 20 can include both a ventricular portion positioned in the ventricle and an atrial portion positioned in the atrium.

[0133] In summary, the heart valve replacement system provided by the embodiments of the present application can further improve the positioning effect of the heart valve replacement device 10 relative to the heart and increase the sealing effect and improve the artificial heart valve replacement effect by the combined action between the heart valve replacement device 10 and the positioning device 20.

[0134] The following will refer to Figure 9 , briefly describe the artificial valve anchoring method applied to the heart valve replacement system of the present application, which mainly includes the following steps:

[0135] The positioning device 20 of the heart valve replacement system is delivered into the heart 30 by the delivery system 4, so that the positioning device 20 is positioned at a specified position in the heart 30, and each native valve leaflet 32 of the heart 30 is in the positioning device 20.

[0136] Specifically, the positioning device 20 can include an atrial portion and a ventricular portion, wherein the atrial portion and the ventricular portion can be connected to each other as a whole, the atrial portion of the positioning device 20 can include a semi-ring structure and can be fixed at the native annulus 34 of the heart 30, thereby achieving the fixation of the positioning device 20 at the native valve, and the ventricular portion of the positioning device 20 can include a closed ring structure for gathering the native valve leaflets 32 of the heart 30 inside the closed ring structure.

[0137] The heart valve replacement device 10 is delivered into the inside of the positioning device 20 by the delivery system 4 (refer to Figure 10A ), and the first clamping member 106 and the second clamping member of the heart valve replacement device 10 are sequentially released to clamp each native valve leaflet 32 of the heart 30 between the first clamping member 106, the second clamping member 108 of the heart valve replacement device 10 and the positioning device 20, so that the heart valve replacement system is positioned relative to the native valve 32 of the heart 30.

[0138] In this embodiment, the specific steps of clamping each native valve leaflet 32 of the heart 30 by the heart valve replacement device 10 can refer to the artificial valve anchoring method applied to the heart valve replacement device 10 described above, which will not be described here.

[0139] In summary, the artificial valve anchoring method applied to the heart valve replacement system provided by the embodiments of the present application can effectively improve the anchoring force of the heart valve replacement device at the native valve while achieving good sealing effect by the accumulation and covering of the native valve leaflets around the positioning device (closed ring structure) and the radial interaction force between the positioning device (closed ring structure) and the annular support of the heart valve replacement device.

[0140] Finally, it should be noted that the above examples are only used to illustrate the technical solutions of the embodiments of the present application, and are not intended to limit them; although the present application has been described in detail with reference to the foregoing examples, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing examples, or make equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A heart valve replacement device, characterized by, The device comprises: a ring-shaped support having oppositely arranged inner and outer surfaces; a leaflet structure comprising a plurality of artificial leaflets arranged along the circumference of the ring-shaped support on the inner surface of the ring-shaped support; a first clamping member and a second clamping member arranged along the axial direction of the ring-shaped support on the outer surface of the ring-shaped support; wherein the ring-shaped support is radially contractible or expandable, and the first clamping member and the second clamping member can clamp the native leaflets of the heart in cooperation so that the leaflet structure is positioned relative to the native valve of the heart; each first clamping unit extends radially outward from the outer surface of the ring-shaped support towards the inflow end of the ring-shaped support; each second clamping unit extends radially outward from the outer surface of the ring-shaped support towards the inflow end or the outflow end of the ring-shaped support; each first clamping unit and each second clamping unit respectively comprises a fixed end connected to the ring-shaped support, a free end opposite to the fixed end, and a middle section between the fixed end and the free end, and the device further comprises a driving part, wherein the driving part is arranged at the free end of each first clamping unit and each second clamping unit; and / or the driving part is arranged at the middle section of each first clamping unit and each second clamping unit; wherein the driving part can be connected to a driving member of a connection and delivery system, and the driving member can control the elastic deformation of each first clamping unit and each second clamping unit to adjust the opening angle of each first clamping unit and each second clamping unit relative to the ring-shaped support.

2. The apparatus of claim 1, wherein, The ring-shaped support comprises: a support ring having a plurality of deformable grid units; a main film attached to the inner side of the support ring or attached to the inner side and the outer side of the support ring.

3. The device according to claim 2, wherein the plurality of deformable grid units comprises at least one of quadrilateral grid units and hexagonal grid units; and wherein each deformable grid unit having the same shape can be arranged in rows and / or arranged in columns.

4. The apparatus of claim 1, wherein, The device further comprises a reinforcing unit arranged on at least one of each first clamping unit and each second clamping unit.

5. The apparatus of claim 1, wherein, The device further comprises an anchoring unit arranged on at least one of each first clamping unit and each second clamping unit.

6. The apparatus of claim 1, wherein, Along the axial direction of the ring-shaped support, each first clamping unit of the first clamping member and each second clamping unit of the second clamping member are arranged in alignment or staggered.

7. The apparatus of claim 1, wherein, The first clamping unit or the second clamping unit comprises one of a clamping sheet and a clamping rod; wherein in the case that the first clamping unit or the second clamping unit comprises the clamping sheet, the first clamping unit or the second clamping unit is in any one of V-shaped, U-shaped, and M-shaped; in the case that the first clamping unit or the second clamping unit comprises the clamping rod, the first clamping unit or the second clamping unit is in any one of J-shaped and S-shaped.

8. The apparatus of claim 1, wherein, The device further comprises a connecting structure arranged at the inflow end of the ring-shaped support and detachably connected to an external device.

9. The apparatus of claim 1, wherein, The spacing distance between the first and second clamping members is between 1 mm and 10 mm.

10. The apparatus of claim 1, wherein, The device further comprises a clamping cover film provided on at least one of the first and second clamping members.

11. A heart valve replacement system, characterized by, Comprising: A heart valve replacement device as claimed in any one of claims 1 to 10; A positioning device positioned between the first and second clamping members of the heart valve replacement device and at a designated location of the heart to fix the heart valve replacement device relative to a native valve of the heart.

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