CN116236319B

CN116236319B - Heart valve replacement device, system and artificial valve anchoring method

Info

Publication number: CN116236319B
Application number: CN202211606675.1A
Authority: CN
Inventors: 耿聪颖; 赵春霞; 徐军
Original assignee: Shanghai Huihe Healthcare Technology Co Ltd
Current assignee: Shanghai Huihe Healthcare Technology Co Ltd
Priority date: 2022-12-13
Filing date: 2022-12-13
Publication date: 2025-10-24
Anticipated expiration: 2042-12-13
Also published as: CN116236319A

Abstract

The present application provides a heart valve replacement device, system, and artificial valve anchoring method. The heart valve replacement device includes an annular support member, a leaflet structure disposed on the inner surface of the annular support member along the circumference of the annular support member, and a first clamping member and a second clamping member disposed on the outer surface of the annular support member along the axial direction of the annular support member. The annular support member can radially contract or expand, and the first clamping member and the second clamping member can cooperate to clamp the native heart leaflets, so that the leaflet structure is positioned relative to the native heart valve. Thus, the present application can provide an optimal artificial valve positioning effect, thereby improving the success rate of valve replacement surgery.

Description

Heart valve replacement devices, systems, and methods of anchoring prosthetic valves

Technical Field

The embodiment of the application relates to the technical field of medical equipment, in particular to a heart valve replacement device, a heart valve replacement system and a prosthetic valve anchoring method.

Background

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, the left atrium pressure is greater than the left ventricle, the mitral valve is opened in diastole, otherwise, the left ventricle pressure is greater than the left atrium, and the mitral valve is closed in systole. The mitral valve is complex in structure and consists of an annulus, leaflets, chordae tendineae and papillary muscles, any part of which is organically or functionally changed, and may cause mitral insufficiency, i.e., the mitral valve cannot be completely closed during systole, so that blood of the left ventricle reversely flows into the left ventricle. Treatments for mitral insufficiency include valve repair and replacement, with valve repair being the common preferred treatment, but valve replacement is the ultimate fundamental solution.

Heart valve replacement may be performed surgically or by means of a transcatheter intervention, which may be accepted for patients with mitral insufficiency who are ill-suited for surgical procedures, for which there are high risk factors such as hypocardiac function, complications, advanced age, etc.

At present, transcatheter aortic valve replacement is a very mature treatment means for aortic valve diseases, a plurality of transcatheter aortic valve products are available on the market, and in recent years, although various structural designs and delivery modes are presented for transcatheter mitral valves, most of the transcatheter mitral valves are in research stages, and the main restriction factors are that firstly, due to the complex structure of the mitral valve, compared with the aortic valve, the whole structure of the mitral valve is D-shaped, the annulus is larger in size, calcification is less, sufficient supporting force cannot be provided for the artificial valve to fix the artificial valve at a diseased mitral valve, and secondly, due to the fact that the left ventricular outflow channel is adjacent to anterior valve leaflets on the anatomical structure, implantation of the artificial valve can cause left ventricular outflow obstruction (LVOTO), which is also to be considered to be avoided when designing the artificial valve, and furthermore, due to the fact that the annulus size of the mitral valve is larger, if the artificial valve is a single-layer stent, compared with the aortic valve, the stent with the larger diameter is required, the corresponding valve area of the artificial valve is correspondingly increased, and fatigue resistance is reduced, and simultaneously, the vascular complications are caused by the increased size of the delivery system.

In view of the foregoing, there is a need for a heart valve replacement product that increases the positioning effect of a prosthetic valve and increases the success rate of the valve replacement procedure.

Disclosure of Invention

In view of the above, the present application provides a heart valve replacement device, system, and method of anchoring a prosthetic valve that overcomes or at least partially solves the above-described problems.

According to a first aspect of the present application there is provided a heart valve replacement device comprising an annular support having oppositely disposed inner and outer surfaces, a leaflet structure comprising a plurality of artificial leaflets disposed on the inner surface of the annular support in a circumferential direction of the annular support, a first and second clip disposed on the outer surface of the annular support in an axial direction of the annular support, wherein the annular support is radially collapsible or expandable, the first and second clips being cooperable to clip native leaflets of a heart such that the leaflet structure is positioned relative to the native valve of the heart.

Optionally, the annular support comprises a support ring having a plurality of deformable grid cells, and a body cover film attached to the inside of the support ring or to the inside and outside of the support ring.

Optionally, the plurality of deformable mesh cells includes at least one of a quadrilateral mesh cell, a hexagonal mesh cell, and wherein the deformable mesh cells having the same shape may be arranged in rows and/or in columns.

The annular support comprises an inflow end and an outflow end which are oppositely arranged along the axial direction of the annular support, wherein the first clamping piece is arranged on one side, close to the outflow end, of the annular support, the second clamping piece is arranged on one side, close to the inflow end, of the annular support, the first clamping piece comprises a plurality of first clamping units circumferentially encircling the outer surface of the annular support, and the second clamping piece comprises a plurality of second clamping units circumferentially encircling the outer surface of the annular support.

Optionally, each first clamping unit extends radially outwardly from an outer surface of the annular support in the direction of the inflow end of the annular support, and each second clamping unit extends radially outwardly from an outer surface of the annular support in the direction of the inflow end or the outflow end of the annular support.

Optionally, each first clamping unit and each second clamping unit respectively comprise a fixed end connected with the annular supporting piece, a free end opposite to the fixed end and a middle section part positioned 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 part of each first clamping unit and each second clamping unit, wherein the driving part can be connected with the driving piece and controls each first clamping unit and each second clamping unit to generate elastic deformation by the acting force of the driving piece so as to adjust the opening and closing angles of each first clamping unit and each second clamping unit relative to the annular supporting piece.

Optionally, the device further comprises a reinforcement unit provided on at least one of each first clamping unit and each second clamping unit.

Optionally, the device further comprises an anchoring unit provided on at least one of each first clamping unit and each second clamping unit.

Optionally, each first clamping unit of the first clamping member and each second clamping unit of the second clamping member are aligned or staggered along the axial direction of the annular supporting member.

Optionally, the first clamping unit or the second clamping unit comprises one of a clamping sheet and a clamping rod, wherein the first clamping unit or the second clamping unit is any one of V-shaped, U-shaped and M-shaped when the first clamping unit or the second clamping unit comprises the clamping sheet, and the first clamping unit or the second clamping unit is any one of J-shaped and S-shaped when the first clamping unit or the second clamping unit comprises the clamping rod.

Optionally, the device further comprises a connection structure provided at the inflow end of the annular support and detachably connected to an external device.

Optionally, the first clamping member and the second clamping member are spaced apart by a distance of between 1mm and 10 mm.

Optionally, the device further comprises a clamping film provided on at least one of the first clamping member and the second clamping member.

According to a second aspect of the present application there is provided a heart valve replacement system comprising a heart valve replacement device according to the first aspect, and positioning means positioned between the first and second clamps of the heart valve replacement device and positioned at a designated location of the heart to secure the heart valve replacement device relative to a native valve of the heart.

According to a third aspect of the present application there is provided a prosthetic valve anchoring method for use with the heart valve replacement device of the first aspect described above, the method comprising delivering the heart valve replacement device into a heart using a delivery system, releasing a first clip of the heart valve replacement device such that a native valve leaflet of the heart is located between the first clip and a second clip of the heart valve replacement device, controlling movement of the heart valve replacement device relative to the heart such that the native valve leaflet folds between the first clip and an annular support of the heart valve replacement device, releasing a second clip of the heart valve replacement device such that the first clip and the second clip cooperate to clip the native valve leaflet and positioning the heart valve replacement device relative to the native valve of the heart.

According to a fourth aspect of the present application, there is provided a prosthetic valve anchoring method applied to the heart valve replacement system of the second aspect, the method comprising delivering a positioning device of the heart valve replacement system into a heart using a delivery system to position the positioning device in a designated location of the heart and to retract each native leaflet of the heart into the positioning device, delivering the heart valve replacement device into the interior of the positioning device using the delivery system and sequentially releasing a first clip and a second clip of the heart valve replacement device to clip each native leaflet of the heart between the first clip, the second clip and the positioning device of the heart valve replacement device to position the heart valve replacement system relative to the native valve of the heart.

In summary, according to the heart valve replacement device provided by the embodiment of the application, the primary valve leaflet of the heart is cooperatively clamped by the first clamping piece and the second clamping piece, so that the valve leaflet structure is positioned relative to the primary valve of the heart, and the anchoring effect of the heart valve replacement device can be improved.

In addition, according to the heart valve replacement device provided by the embodiment of the application, the primary valve leaflets of the heart are folded and piled between the first clamping piece and the second clamping piece, so that a good sealing effect can be realized, and the problem of heart blood backflow is effectively prevented.

Furthermore, in the heart valve replacement system provided by the embodiment of the application, the heart valve replacement device is placed in the positioning device, so that the anchoring force and the sealing effect of the native valve She Chu of the heart valve replacement device are effectively enhanced by virtue of the radial interaction force between the positioning device and the heart valve replacement device.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings may be obtained according to these drawings for a person having ordinary skill in the art.

Fig. 1 to 3 are schematic views showing the overall structure of a heart valve replacement device according to various embodiments of the present application.

Fig. 4A to 4E are schematic structural views of a ring support according to various embodiments of the present application.

Fig. 5 and fig. 6 are schematic structural diagrams of a first clamping member and a second clamping member according to different embodiments of the present application.

Fig. 7A to 7C are schematic structural diagrams of a first clamping unit and a second clamping unit according to different embodiments of the present application.

Fig. 8 is a schematic illustration of the application of a heart valve replacement device according to an exemplary embodiment of the present application.

Fig. 9 is a schematic illustration of the application of a heart valve replacement system in accordance with an exemplary embodiment of the present application.

Fig. 10A-10B are schematic illustrations of the implementation of a prosthetic valve anchoring method according to an exemplary embodiment of the present application.

Element labels

A heart valve replacement device;

102, annular supporting piece;

102a, inner surface;

102b, an outer surface;

104, leaflet structure;

105, artificial valve leaves;

106, a first clamping piece;

108, a second clamping piece;

110, a support ring;

112, deformable grid cells;

112a, quadrilateral grid cells;

112b hexagonal grid cells;

114, coating a main body;

116, inflow end;

118, outflow end;

a first clamping unit 120;

122 a second clamping unit;

124, fixed end;

126, free end;

128, a middle section;

129a/129b drive portion;

1291, perforating holes;

130, a reinforcement unit;

132 an anchoring unit;

134, clamping the coating film;

136, a connection structure;

20, a positioning device;

30, heart;

32, native valve leaflets;

34, native annulus;

4, a conveying system;

42, conveying the outer sheath;

44, delivering the inner sheath.

Detailed Description

In order to better understand the technical solutions in the embodiments of the present application, the following description will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the accompanying drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the present application, shall fall within the scope of protection of the embodiments of the present application.

Currently, for transcatheter mitral valve replacement products, most of them include a crown structure, for example, the valve replacement structures disclosed in CN114288069a, CN114305805A and CN114305806a all include a crown for fixing the valve skirt, and the crown plays a role in positioning and sealing, but the presence of the crown may cause the risks of thrombus, hemolysis, endothelialization insufficiency, etc., and if the crown is not matched with the native annulus of the heart, the whole replacement valve is inclined, and paravalvular leakage occurs.

In view of the above, various embodiments of the present application provide a heart valve replacement device with improved structure, so as to solve various technical problems in the prior art.

Embodiments of the present application will be further described with reference to the accompanying drawings.

Fig. 1-3 are schematic perspective views of a heart valve replacement device 10 according to various embodiments of the present application. As shown, the heart valve replacement device 10 of the present embodiment generally includes an annular support 102, a leaflet structure 104, a first clip 106, and a second clip 108.

The annular support 102 has oppositely disposed inner and outer surfaces 102a, 102b (see fig. 5 and 6).

In this embodiment, the annular support 102 may radially contract or expand.

Specifically, positioning of the heart valve replacement device 10 within the heart may be accomplished by controlling radial contraction of the annular support 102 to receive the heart valve replacement device 10 within a delivery catheter to perform a delivery operation, and controlling radial expansion of the annular support 102 after the heart valve replacement device 10 is delivered to a designated location within the heart via the catheter.

Alternatively, the annular support 102 may include a support ring 110 and a body cover 114.

Referring to fig. 4A to 4D, the support ring 110 has a plurality of deformable mesh cells 112.

Alternatively, the deformable mesh cells 112 include at least one of quadrangular mesh single rings 112a, hexagonal mesh cells 112b, and the respective deformable mesh cells 112 having the same shape may be arranged in rows and/or in columns.

In an embodiment, in the case where each of the deformable mesh cells 112 constituting the annular support 102 is a quadrangular mesh cell 112a (refer to fig. 4C), or in the case where each of the deformable mesh cells 112 constituting the annular support 102 is a hexagonal mesh cell 112b (not shown), the deformable mesh cells 112 having the same shape may be arranged in rows and in columns in the radial direction of the annular support 102.

In another embodiment, in the case where each of the deformable mesh cells constituting the annular support 102 includes both the quadrangular mesh cells 112a and the hexagonal mesh cells 112B (refer to fig. 4A, 4B), the respective deformable mesh cells 112 having the same shape may be arranged in rows along the radial direction of the annular support 102.

The body cover 114 may be attached to the inner side of the support ring 110 (see the embodiment shown in fig. 1), or the body cover 114 may be attached to both the inner side and the outer side of the support ring 110 (see the embodiment shown in fig. 2).

In this embodiment, the main body coating 114 may be made of a polymer coating with good biocompatibility, for providing a sealing effect to achieve the effect of preventing the backflow of blood.

The leaflet structure 104 includes a plurality of artificial leaflets 105 provided to the inner surface 102a of the annular support 102 in the circumferential direction of the annular support 102. For example, in the embodiment shown in fig. 5 and 6, the leaflet structure 104 comprises three artificial leaflets 105 distributed along the circumference of the annular support 102, on the inner surface 102a of the annular support 102.

A first clamping member 106 and a second clamping member 108, which are provided on the outer surface 102b of the annular support member 102 in the axial direction of the annular support member 102. The first clamp 106 and the second clamp 108 may cooperatively clamp the native valve leaflet 32 of the heart 30 such that the leaflet structure 104 is positioned relative to the native valve of the heart 30.

Alternatively, the separation distance between the first clamp 106 and the second clamp 108 may be between 1mm and 10 mm.

In this embodiment, the native leaflets 32 of the heart 30 can be folded and stacked between the first and second clamping members 106, 108 (see fig. 8) to achieve a good seal.

In the present embodiment, the annular support 102 includes an inflow end 116 and an outflow end 118 (refer to fig. 1 to 4E) disposed opposite to each other in the axial direction thereof.

Specifically, the first clamping member 106 is disposed on the annular support member 102 on a side thereof proximate the outflow end 118, and the second clamping member 108 is disposed on the annular support member 102 on a side thereof proximate the inflow end 116.

Alternatively, the first clamping member 106 includes a plurality of first clamping units 120 circumferentially surrounding the outer surface 102b of the annular support member 102, and the second clamping member 108 includes a plurality of second clamping units 122 circumferentially surrounding the outer surface 102b of the annular support member 102 (refer to fig. 2 to 6).

In this embodiment, each of the first clamping units 120 and each of the second clamping units 122 includes a fixed end 124 connected to the annular support 102, a free end 126 opposite to the fixed end 124, and a middle portion 128 (refer to fig. 5) located between the fixed end 124 and the free end 126.

Alternatively, each of the first clamping units 120 of the first clamping member 106 may extend radially outwardly from the outer surface 102b of the annular support 102 in the direction of the inflow end 116 of the annular support 102 (refer to fig. 1-3).

Alternatively, each second clamping unit 122 of the second clamping member 108 may extend radially outwardly from the outer surface 102b of the annular support member 102 in the direction of the inflow end 116 of the annular support member 102 (refer to fig. 1-3, 4A). In this case, the extending directions of the first clamping units 120 and the second clamping units 122 are the same, that is, each of the first clamping units 120 and the second clamping units 122 extends obliquely toward the inflow end 116 of the annular support 102, and the structural design can be used for the heart valve replacement device 10 to cooperate with an additional structure (such as a positioning device 20 described below) so as to improve the positioning effect of the heart valve replacement device 10.

Alternatively, each second clamping unit 122 of the second clamping member 108 may extend radially outwardly from the outer surface 102B of the annular support member 102 in the direction of the outflow end 118 of the annular support member 102 (refer to fig. 4B, 4C). In this case, the extending directions of the first clamping units 120 and the second clamping units 122 are opposite, that is, the first clamping units 120 near the outflow end 118 extend obliquely toward the inflow end 116 of the annular support 102, the second clamping units 122 near the inflow end 116 extend obliquely toward the outflow end 118 of the annular support 102, and the structure design can make the native valve leaflet 32 difficult to separate from the first clamping member 106 (the first clamping unit 120) and the second clamping member (the second clamping unit 122), reduce the risk of the heart valve replacement device 10 slipping from the native valve leaflet 32, and enhance the anchoring force of the annular support 102.

Optionally, the heart valve replacement device 10 further comprises a driving portion 129a/129b (see fig. 7A) which may be provided at the free end 126 of each of the first clamping unit 120 and the second clamping unit 122, and/or at the middle section 128 of each of the first clamping unit 120 and the second clamping unit 122.

The driving portion 129a/129b may be connected to a driving member (e.g. a traction wire), and may control the first clamping units 120 and the second clamping units 122 to elastically deform under the action of the driving member, so as to adjust the opening and closing angles of the first clamping units 120 and the second clamping units 122 relative to the annular support 102.

In the present embodiment, the driving portion 129a/129b may extend from the first clamping unit 120 or the second clamping unit 122 and have a through hole 1291 (refer to fig. 7A).

The driving member (e.g. a traction wire) may be inserted into the insertion hole 1291 of the driving portion 129a or 129b, so that the driving portion 129a or 129b may be acted by the driving member to control the first clamping units 120 or the second clamping units 122 to generate different degrees of elastic deformation, thereby adjusting the opening and closing angles of the first clamping units 120 and the second clamping units 122 relative to the annular support 102.

In this embodiment, the driving portion 129 may be of an I-type or a Y-type, when the driving portion 129 is of an I-type (refer to 129a of fig. 7A), a 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, a through hole 1291 is provided at a second end of the driving portion 129a opposite to the first end, and when the driving portion 129 is of a Y-type (refer to 129b of fig. 7A), two ends of the driving portion 129b are respectively connected to two opposite sides of the terminal portion 128 of the first clamping unit 120 or the second clamping unit 122.

In other embodiments, the driving portion 129a or 129B may include only a through hole 1291 and may be formed at the free end 126 and/or the middle portion 128 of the first clamping unit 120 or the second clamping unit 122 for passing through the driving portion (see fig. 7B).

It should be noted that, the connection form 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 embodiment, and may be arbitrarily adjusted according to the actual requirement by those skilled in the art, which is not limited in the present application.

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

For example, in the embodiment shown in fig. 7C, a reinforcement unit 130 may be provided at the middle section 128 of the first clamping unit 120 or the second clamping unit 122 for reinforcing the structural strength of the first clamping unit 120 or the second clamping unit 122.

It should be noted that the structural configuration of the reinforcement unit 130 is not limited to the V-shaped structure shown in fig. 7C, and the position of the reinforcement unit 130 disposed on the first clamping unit 120 or the second clamping unit 122 is not limited to the middle portion 128 shown in fig. 7C, and those skilled in the art can adjust the structure according to the actual requirement, which is not limited in the present application.

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

In the present embodiment, the anchoring unit 132 may be a barb (refer to fig. 4D or fig. 4E) disposed on the free end 126 of the first clamping unit 120 or the second clamping unit 122 for increasing the anchoring force of the first clamping unit 120 or the second clamping unit 122 to the native valve leaflet 32, so that the native valve 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 slipping.

Preferably, the tips of the barbs (anchoring units 132) provided on the second gripping unit 122 may extend toward the outflow end 118 of the annular support 102 to facilitate penetration of the tips of the barbs (anchoring units 132) provided thereon into the native valve leaflet 32 after the second gripping unit 122 is released, thereby increasing the anchoring force of the second gripping unit 122 against the native valve leaflet 32.

It should be noted that the structure of the anchoring unit 132 is not limited to barbs, and the anchoring unit 132 may be disposed at the middle section 128 of the first clamping unit 120 or the second clamping unit 122, and those skilled in the art may make any adjustment according to practical requirements, which is not limited in the present application.

Alternatively, each first clamping unit 120 of the first clamping member 106 and each second clamping unit 122 of the second clamping member 108 may be disposed in alignment (see fig. 5) or in staggered arrangement (see fig. 6) along the axial direction of the annular support member 102.

Alternatively, the first clamping unit 120 or the second clamping unit 122 may be a clamping piece or a clamping rod.

In the present embodiment, in the case where the first clamping unit 120 or the second clamping unit 122 includes a clamping piece (refer to fig. 4A to 4C, 4E), the first clamping unit 120 or the second clamping unit 122 may have a V-shape, a U-shape, an M-shape, or the like.

In the present embodiment, in the case where the first clamping unit 120 or the second clamping unit 122 includes a clamping bar (refer to fig. 4D), the first clamping unit 120 or the second clamping unit 122 may have a J-shape, an S-shape, or the like.

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

Specifically, in the embodiment shown in fig. 1 and 2, the clamping film 134 is attached to the surfaces of both the first clamping member 106 and the second clamping member 108, and in the embodiment shown in fig. 3, the clamping film 134 is attached to only the surface of the first clamping member 106.

In this embodiment, the holding film 134 may include a polymer film with good biocompatibility.

Optionally, the heart valve replacement device 10 further includes a connection structure 136 provided at the inflow end 116 of the annular support 102 and removably connected to an external device (see fig. 4A-4E).

For example, the attachment structure 136 may be used to provide for the attachment engagement of the heart valve replacement device 10 to a fixture (not shown) on the delivery system to ensure that the heart valve replacement device 10 does not become dislodged during delivery.

The prosthetic valve anchoring method of the present application applied to the heart valve replacement device 10 will be briefly described below with reference to fig. 8, 10A, and 10B, and mainly comprises the steps of:

the heart valve replacement device 10 is delivered into the heart 30 using the delivery system 4.

In this embodiment, the delivery system 4 includes a delivery sheath 42 and a delivery sheath 44, wherein the delivery sheath has fasteners disposed thereon that are connectable to the connection structure 136 on the annular support 102 of the heart valve replacement device 10 to prevent displacement of the heart valve replacement device during delivery and release.

The first clip 106 of the heart valve replacement device 10 is released such that the native leaflets 32 of the heart 30 are located between the first clip 106 and the second clip 108 of the heart valve replacement device 10 (see fig. 10A and 10B).

In this 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 traction wire) by the driving portions 129a/129b, and the driving member is connected to an end portion of the delivery sheath, so that a force can be applied to the first clamping member 106 and the second clamping member 108 by the driving member to adjust the opening/closing angle of each of the first clamping unit 120 and the second clamping unit 122 in the first clamping member 106 and the second clamping member 108 relative to the annular support 102.

In particular, the first clip 106 proximate the outflow end 118 can be released via a driver (e.g., a pull wire) while increasing the spacing between the end of the delivery sheath of the delivery system 4 and the outflow end of the annular support 102 such that the angle of deployment of the first clip 106 increases, thereby facilitating capture of the free edge of the native leaflet 32 between the first clip 106 and the annular support 102.

The heart valve replacement device 10 is controlled to move relative to the heart 30 such that the native leaflets 32 fold between the first clamping body and the annular support 102 of the heart valve replacement device 10.

In particular, the heart valve replacement device 10 as a whole may be pulled upward such that the native leaflets 32 fold within the space between the first clip 106 and the annular support 102.

The second clamp 108 of the heart valve replacement device 10 is released such that the first clamp 106 and the second clamp 108 cooperate to clamp the native valve leaflet 32 and position the heart valve replacement device 10 relative to the native valve of the heart 30.

Specifically, the second clamp 108 proximate the inflow end 116 can be released via a driver (e.g., a pull wire) such that the second clamp 108 returns to the original, expanded state, thereby clamping the folded native leaflet 32 between the first clamp 106 and the second clamp 108, thereby effecting fixation of the annular support 102 at the native leaflet 32.

Alternatively, the annular support 102 of the heart valve replacement device 10 may be released to radially expand while the second clamp 108 of the heart valve replacement device 10 is released, or the annular support 102 of the heart valve replacement device 10 may be released to radially expand after the second clamp 108 of the heart valve replacement device 10 is released.

Therefore, the anchoring method for the heart valve replacement device 10 provided in the present embodiment can clamp the folded native valve leaflet between the first clamping member and the second clamping member to form a sandwich effect, so as to fix the annular supporting member on the native valve leaflet, and achieve a good sealing effect by folding and stacking the native valve leaflet and coating the supporting ring, the first clamping member and the second clamping member.

Another embodiment of the present application provides a heart valve replacement system comprising a heart valve replacement device 10 and a positioning device 20 (see fig. 9).

The structural design of the heart valve replacement device 10 is described with reference to the embodiments of fig. 1-8, and is not described in detail herein.

The positioning device 20 is positionable between the first clamp 106 and the second clamp 108 of the heart valve replacement device 10 and in a designated position of the heart 30 to secure the heart valve replacement device 10 relative to the native valve of the heart 30.

Alternatively, the positioning device 20 may comprise a ventricular portion positioned in a ventricle, or the positioning device 20 may comprise both a ventricular portion positioned in a ventricle and an atrial portion positioned in an atrium.

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

The method of anchoring a prosthetic valve applied to a heart valve replacement system according to the present application will be briefly described with reference to fig. 9, which mainly comprises the steps of:

The positioning device 20 of the heart valve replacement system is delivered into the heart 30 using the delivery system 4 to position the positioning device 20 at a specified location within the heart 30 and to position each native leaflet 32 of the heart 30 within the positioning device 20.

Specifically, the positioning device 20 may include an atrial portion and a ventricular portion, wherein the atrial portion and the ventricular portion may be integrally connected to each other, the atrial portion of the positioning device 20 may include a half-ring structure, and may be secured at the native annulus 34 of the heart 30, thereby enabling the securing of the positioning device 20 at the native valve, and the ventricular portion of the positioning device 20 may include a closed-ring structure for collapsing the native leaflets 32 of the heart 30 inside the closed-ring structure.

The heart valve replacement device 10 is delivered to the interior of the positioning device 20 using the delivery system 4 (see fig. 10A) and the first clamp 106 and the second clamp of the heart valve replacement device 10 are sequentially released to clamp each native leaflet 32 of the heart 30 between the first clamp 106, the second clamp 108, and the positioning device 20 of the heart valve replacement device 10 to position the heart valve replacement system relative to the native valve 32 of the heart 30.

In this embodiment, the specific steps of using the heart valve replacement device 10 to clamp each native leaflet 32 of the heart 30 can refer to the above-mentioned artificial valve anchoring method applied to the heart valve replacement device 10, and will not be described herein.

In summary, the prosthetic valve anchoring method applied to the heart valve replacement system provided in the present embodiment utilizes the stacking and wrapping of the native valve around the positioning device (the closed loop structure) and the radial interaction force between the positioning device (the closed loop structure) and the annular support of the heart valve replacement device, so that the anchoring force of the heart valve replacement device at the native valve can be effectively improved while achieving a good sealing effect.

It should be noted that the above-mentioned embodiments are merely for illustrating the technical solutions of the embodiments of the present application, and not for limiting the same, and although the present application has been described in detail with reference to the above-mentioned embodiments, it should be understood by those skilled in the art that the technical solutions described in the above-mentioned embodiments may be modified or some technical features may be equivalently replaced, and these modifications or substitutions 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, comprising:

an annular support having oppositely disposed inner and outer surfaces;

A leaflet structure comprising a plurality of artificial leaflets disposed on an inner surface of the annular support in a circumferential direction of the annular support;

the first clamping piece and the second clamping piece are arranged on the outer surface of the annular supporting piece along the axial direction of the annular supporting piece;

Wherein the annular support is radially contractible or expandable, the first and second clamps being cooperable to clamp native leaflets of a heart such that the leaflet structure is positioned relative to a native valve of the heart;

Each first clamping unit extends radially outwards from the outer surface of the annular support towards the inflow end of the annular support;

Each second clamping unit extends radially outwards from the outer surface of the annular support towards the direction of the inflow end or the direction of the outflow end of the annular support;

Each of the first clamping units and each of the second clamping units includes a fixed end connected to the annular support member, a free end opposite to the fixed end, a middle section located between the fixed end and the free end, the apparatus further includes a driving section, wherein,

The driving part is arranged at the free ends of the first clamping units and the second clamping units and/or

The driving part is arranged at the middle section part of each first clamping unit and each second clamping unit;

The driving part can be used for connecting a driving piece connected with the conveying system, and the acting force of the driving piece controls each first clamping unit and each second clamping unit to generate elastic deformation so as to adjust the opening and closing angles of each first clamping unit and each second clamping unit relative to the annular supporting piece.

2. The apparatus of claim 1, wherein the annular support comprises:

a support ring having a plurality of deformable grid cells;

and a main body coating 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 apparatus of claim 2, wherein the device comprises a plurality of sensors,

The deformable grid cells at least comprise one of quadrilateral grid cells and hexagonal grid cells;

And wherein the deformable grid cells having the same shape may be arranged in rows and/or in columns.

4. The apparatus of claim 1, further comprising a stiffening unit provided on at least one of each of the first clamping units and each of the second clamping units.

5. The device of claim 1, further comprising an anchor unit provided on at least one of each of the first clamping units and each of the second clamping units.

6. The device according to claim 1, wherein each first clamping unit of the first clamping member is arranged in alignment with each second clamping unit of the second clamping member or in staggered arrangement along the axial direction of the annular support member.

7. The apparatus of claim 1, wherein the first clamping unit or the second clamping unit comprises one of a clamping tab, a clamping bar, wherein,

In the case where the first clamping unit or the second clamping unit includes the clamping piece, the first clamping unit or the second clamping unit is any one of V-type, U-type, M-type;

in the case where the first clamping unit or the second clamping unit includes the clamping lever, the first clamping unit or the second clamping unit is either J-shaped or S-shaped.

8. The device of claim 1, further comprising a connection structure provided at the inflow end of the annular support member and removably connected to an external device.

9. The device of claim 1, wherein a separation distance between the first clamp and the second clamp is between 1mm and 10 mm.

10. The device of claim 1, further comprising a clamping overlay disposed on at least one of the first clamping member and the second clamping member.

11. A heart valve replacement system, comprising:

The heart valve replacement device of any one of claims 1 to 10;

A positioning device positioned between the first and second clamps of the heart valve replacement device and positioned at a designated location of the heart to secure the heart valve replacement device relative to a native valve of the heart.