CN117297831A

CN117297831A - Mitral valve device

Info

Publication number: CN117297831A
Application number: CN202210703476.6A
Authority: CN
Inventors: 梁玉晨; 彭骏
Original assignee: Qichen Shanghai Medical Equipment Co ltd
Current assignee: Qichen Shanghai Medical Equipment Co ltd
Priority date: 2022-06-21
Filing date: 2022-06-21
Publication date: 2023-12-29

Abstract

The invention belongs to the technical field of medical appliances, and particularly relates to a mitral valve device. A mitral valve device, comprising: the support mechanism is provided with an outer support and an inner support connected with the outer support; the outer layer support is a braided support formed by braiding braided wires, a plurality of outer frame connecting rings are braided inwards by the braided wires at the proximal end of the outer layer support, and at least the proximal end inner diameter of the outer layer support is larger than the distal end outer diameter of the inner layer support; the far end of the inner layer support is provided with a plurality of inner frame connecting buckles, and the inner layer support is hung on the inner side of the outer layer support by adopting the buckle connection between the inner frame connecting buckles and the outer frame connecting rings. The outer layer support is a woven support formed by weaving the woven wires, can be better attached to the inner wall of the heart, and effectively reduces the perivalvular leakage. The inner diameter of the outer layer bracket is larger than that of the inner layer bracket, and the outer layer bracket and the inner layer bracket are of an overhead structure except for the ring buckle connecting part, so that the influence of myocardial motion on the mitral valve device is effectively reduced.

Description

Mitral valve device

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a mitral valve device.

Background

Mitral valve replacement is one of the main means for treating severe mitral regurgitation, and at present, there are mainly traditional open chest surgery and minimally invasive interventional surgery developed in recent years, and due to the large trauma, high risk and long-term and expensive rehabilitation treatment after surgery, a large number of patients are reluctant to accept or cannot bear the treatment mode. And a novel treatment method with less wound, less complication and quick postoperative rehabilitation is provided for doctors by the internal medicine operation of the transcatheter heart valve treatment in the minimally invasive intervention operation. For transcatheter mitral valve devices, catheter diameter and post-implantation regurgitation flow have been important indicators for evaluating their performance. Most of the currently existing prosthetic mitral valves on the market have the following problems:

(1) The stent with a single layer is in direct contact with the valve annulus, so that the stent is greatly influenced by myocardial motion and is easy to generate larger reflux.

(2) The double-layer stent is influenced by the structure, and the diameter of the double-layer stent is generally larger after compression, so that the diameter of a corresponding conveying catheter is larger.

Thus, less regurgitation and smaller compressed diameters remain an important point of transcatheter mitral valve development.

Disclosure of Invention

The invention aims at solving the technical problem that the existing mitral valve device is easy to generate reflux or has larger compression diameter during delivery.

A mitral valve device, comprising:

the support mechanism is provided with an outer support and an inner support connected with the outer support;

the outer layer support is a braided support formed by braiding braided wires, a plurality of outer frame connecting rings are braided inwards by the braided wires at the proximal end of the outer layer support, and at least the proximal inner diameter of the outer layer support is larger than the distal outer diameter of the inner layer support;

the far end of the inner layer support is provided with a plurality of inner frame connecting buckles, and the inner frame connecting buckles are connected with the outer frame connecting rings through ring buckles to realize that the inner layer support is hung on the inner side of the outer layer support.

As a preferable scheme, the number of the outer frame connecting rings is N, N is more than or equal to 3, and at least N outer frame connecting rings are uniformly distributed on the inner side of the proximal end of the outer frame;

the number of the inner frame connecting buckles is the same as that of the outer frame connecting rings, and at least three inner frame connecting buckles are uniformly distributed at the far end of the inner layer support and are in one-to-one corresponding ring buckle connection with the outer frame connecting rings.

As a preferable scheme, the braiding wires at the proximal end of the outer stent are braided inwards in an inclined way to form an inner folded outer stent connecting rod, and the outer stent connecting ring is braided at the distal end part of the outer stent connecting rod;

the included angle between the outer frame connecting rod and the axis of the outer frame support is smaller than 90 degrees, preferably 15-75 degrees, more preferably 30-60 degrees;

the inner frame connecting buckle is provided with a straight rod extending towards the far end, and the far end part of the straight rod is provided with a ring buckle structure which is buckled with the outer frame connecting ring.

Preferably, the outer stent comprises:

an outer frame body, a hollow cylinder-like structure.

Preferably, the distal end of the outer frame body is turned outwards to form a lower skirt, and the lower skirt is circumferentially distributed along the outer side of the distal end of the outer frame body.

Preferably, the proximal end of the outer frame main body is turned inwards to form an upper skirt edge, and the outer frame connecting ring is uniformly arranged on the inner side of the proximal end of the upper skirt edge in the circumferential direction.

Preferably, the outer frame body is a hollow cylinder-like structure with large proximal and distal diameters and small middle diameter.

Preferably, the upper skirt is a reducing annular structure with the diameter increasing from the distal end to the proximal end and then decreasing.

Preferably, the lower skirt comprises a first eversion, the central axis of the outer frame body being at an angle of 120 ° < α < 170 °, preferably 110 ° < α < 160 °.

Preferably, the lower skirt comprises a second eversion, the central axis of the outer frame body being at an angle of 10 ° < β < 100 °, preferably 30 ° < β < 95 °.

Preferably, the lower skirt is a reducing annular structure with the diameter increasing from the distal end to the proximal end and then decreasing.

As a preferable scheme, the upper skirt edge, the outer frame main body and the lower skirt edge are all woven by adopting weaving wires to form a woven bracket with a woven net;

the woven mesh is a circular, elliptic, rectangular or rhombic woven mesh.

Preferably, the number of the woven meshes in the lower skirt is 6N, and N is a natural number not less than 1.

As a preferred scheme, the inner frame connecting buckle is provided with a ring buckle structure, and the ring buckle structure comprises:

one side of the main body part extends to form a hook-shaped part, and the end part of the hook-shaped part is provided with a non-return opening;

the rotating arm is pivoted with the other side of the main body part and provided with a spigot at the end part, and the spigot is in butt joint with the check port to lock the rotating arm on the hook part.

Preferably, the inner layer bracket comprises:

the inner frame main body is of a hollow cylindrical structure, and the inner frame connecting buckles are uniformly arranged along the circumferential direction of the far end.

Preferably, the inner frame body adopts a net structure and can be radially expanded or contracted.

As a preferable scheme, the inner layer bracket is a bracket which is integrally manufactured by cutting a steel pipe, a nickel-titanium pipe or a cobalt-chromium pipe.

As a preferred scheme, the inner frame body has at least one circle of diamond-shaped net rack, the diamond-shaped net rack includes:

the inner side surfaces of the diamond-shaped frames are arc surfaces, and frames between adjacent diamond-shaped frames are shared;

and the vertex angles of two adjacent diamond-shaped frames are sequentially connected through the connecting blocks to form the diamond-shaped net rack.

Preferably, the inner frame body is provided with at least two circles of diamond-shaped net racks, and adjacent diamond-shaped net racks are sequentially connected through the connecting blocks to form the inner frame body.

Preferably, the angle of the apex angle of the diamond-shaped frame along the axial direction is 100-150 degrees.

Preferably, the outer side surface of the diamond-shaped frame, where the vertex angle is located, at the proximal end or the distal end is an arc surface protruding towards the proximal end or the distal end.

Preferably, the inner frame connecting buckle is integrally arranged on the vertex angle of the diamond-shaped frame positioned at the far end in the inner frame main body.

Preferably, the mitral valve device further comprises:

a valve leaf mechanism positioned at the inner side of the inner frame main body;

the leaflet mechanism includes:

the valve body with the outer circumference of a circular ring structure is formed by sequentially connecting a plurality of valve leaves, and the middle part of the valve body can be opened and closed in a unidirectional way.

As a preferable scheme, the inner frame main body is provided with:

the leaflet connecting rods are uniformly arranged along the circumferential direction of the far end of the inner frame main body;

the leaflets each comprise:

the tail part of the valve leaflet is provided with a protruding structure at the outer side and a sewing edge at the outer side edge;

the inner side edge of the sealing strip is a free edge, and the outer side of the sealing strip is integrally connected with the inner side of the tail part of the valve leaflet;

the two suture ears are respectively arranged at two sides of the sealing strip, and are folded and embedded with clamping pieces to form a folding structure with a supporting function, and the valve leaflet is fixed on the valve leaflet connecting rod along the blood flowing direction through the folding structure;

two adjacent valve leaves are sequentially connected through the folding structure to form the valve body, a plurality of sewing edges form a circular ring shape and are connected with an inner frame sewing film on the inner frame main body in a sewing mode, and the end parts of the inner side faces of the free edges in the two adjacent valve leaves are contacted to realize that the middle part of the valve body can be opened and closed in a unidirectional mode.

As a preferable scheme, the leaflet connecting rod is provided with a leaflet connecting suture hole;

the clamping piece is provided with a clamping piece sewing hole;

and the connection of the valve leaflet and the valve leaflet connecting rod is realized through the suture connection of the valve leaflet connecting suture hole and the clamping piece suture hole.

Preferably, the thickness of the clamping piece is 0.1 mm-0.5 mm.

As a preferable scheme, the inner frame main body is provided with:

the valve leaflet connecting rods are uniformly arranged along the circumferential direction of the far end of the inner frame main body, and are provided with valve leaflet connecting suture holes;

the leaflets each comprise:

the two suture lugs are respectively arranged at two sides of the sealing strip, pass through the leaflet connecting suture holes and turn around the leaflet connecting rod, and are in suture connection with the sealing strip and the adjacent suture lugs;

two adjacent valve leaves are sequentially connected through the folded suture lugs to form the valve body, a plurality of suture edges form a circular ring shape and are connected with an inner frame suture membrane on the inner frame main body in a suture mode, and the end parts of the inner side faces of the free edges in the two adjacent valve leaves are contacted to realize that the middle part of the valve body can be opened and closed unidirectionally.

Preferably, the leaflet further comprises:

and the wear-resistant edge strip is connected with the outer side of the tail part of the leaflet in a sewing way.

Preferably, the mitral valve device further comprises:

the suture membrane mechanism is coated on the bracket mechanism;

the suturing membrane mechanism comprises:

an outer frame sewing film fixed on the outer sides of the outer frame main body and the upper skirt through sewing lines;

a lower skirt suture film fixed to the outer side of the lower skirt by a suture thread;

an inner frame suture film fixed on the inner side of the inner frame main body through suture lines;

and the connecting film is respectively connected with the outer frame sewing film and the inner frame sewing film through suture lines, so that the sewing film mechanisms are connected into a whole.

As a preferable scheme, the outer frame sewing film is unfolded to be of a strip-shaped structure, and surrounds the side surfaces of the outer frame main body and the upper skirt and is coated on the side surfaces of the outer frame main body and the upper skirt;

the proximal end of the outer frame suture membrane is provided with a tooth-shaped structure, and the tooth-shaped structure is turned outwards or inwards to cover the outer frame connection ring.

Preferably, the lower skirt suture film is unfolded to be of an arc-shaped sheet structure, and the lower skirt suture film is wrapped around the lower skirt.

As a preferable scheme, the inner frame suture film is unfolded to be of a strip-shaped structure, and surrounds the side surface of the inner frame main body and is coated on the side surface of the inner frame main body;

the far end of the inner frame suture membrane is provided with a tooth-shaped structure, and the tooth-shaped structure is turned outwards or inwards to cover the leaflet connecting rod on the inner frame main body and the inner frame connecting buckle.

Preferably, the connecting film is unfolded to be of an arc-shaped sheet structure, and the connecting film surrounds between the outer frame main body and the inner frame main body and is respectively connected with the outer frame main body and the inner frame main body in a sewing mode.

The invention has the positive progress effects that: the invention adopts the mitral valve device and has the following advantages:

1. the outer layer support is a woven support formed by weaving woven wires, and can be better attached to the inner wall of the heart, so that the leakage of the periphery of the valve is effectively reduced.

2. The connecting part of the outer layer bracket and the inner layer bracket adopts an inward bending structure, and can be converted from a single-layer structure into a double-layer structure in the release process of the mitral valve device, so that the compressible diameter of the valve device is smaller than that of other double-layer valve devices, and the advantages of the single-layer bracket and the double-layer bracket can be achieved.

3. The inner diameter of the outer support is larger than that of the inner support, the outer support and the inner support are connected through the outer support connecting ring and the inner support connecting buckle through the ring buckle, and the rest parts except the ring buckle connecting part are of an overhead structure, so that the influence of myocardial motion on the mitral valve device is effectively reduced. The mode of the ring buckle connection ensures that the connection is stable and has a certain degree of freedom, and can also prevent the excessive bending of the connection point of the inner frame and the outer frame in the compression and release process of the mitral valve device.

4. The outer frame main body is of a hollow cylinder-like structure with slightly larger diameters at two ends and slightly smaller diameter at the middle part, and the contact area with the valve ring can be increased through the contact of the slightly smaller diameter part at the middle part with the valve ring, so that the perivalvular leakage is reduced.

5. The outer layer support is fixed on the atrial side by adopting an upper skirt edge structure, is fixed on the ventricular side by adopting a lower skirt edge structure, is tightly attached to the atrium and the ventricle, and forms a double skirt edge attaching mode, so that the perivalvular leakage of the mitral valve device after implantation can be well reduced. The design of the lower skirt edge structure forms a structure matched with the mitral valve annulus through twice eversion of the far end of the outer frame main body, so that the mitral valve device has a good sealing effect at the ventricular end, and the perivalvular leakage is further avoided.

6. The outer layer support adopts a woven support, and the inner layer support adopts a cutting support and is hung in the outer layer support, and the influence of myocardial motion on the valve leaflet can be effectively reduced because the hardness of the woven support is lower than that of the cutting support.

Drawings

FIG. 1 (a) is a schematic diagram of the overall structure of the present invention;

FIG. 1 (b) is another angular schematic view of FIG. 1;

FIG. 1 (c) is a front view of FIG. 1 (a);

FIG. 2 (a) is a schematic structural view of an outer stent of the present invention;

FIG. 2 (b) is another angular schematic view of FIG. 2 (a);

fig. 2 (c) is a front view of fig. 2 (a);

fig. 2 (d) is a partial enlarged view of fig. 2 (c);

fig. 2 (e) is a partial enlarged view of fig. 2 (c);

FIG. 3 is an enlarged schematic view of a portion of the outer frame attachment ring of the present invention;

FIG. 4 (a) is a schematic structural view of an inner stent of the present invention;

FIG. 4 (b) is another angular schematic view of FIG. 4 (a);

FIG. 5 (a) is an enlarged schematic view of a portion of an inner frame connector in an inner frame bracket according to the present invention;

FIG. 5 (b) is an enlarged schematic view of a portion of the leaflet attachment rod of the inner stent of the present invention;

FIG. 5 (c) is an enlarged schematic view of a portion of a diamond-shaped frame of the inner stent of the present invention;

FIG. 6 (a) is a schematic view of a leaflet mechanism of the present invention;

FIG. 6 (b) is an exploded view of FIG. (a);

FIG. 7 (a) is a schematic view of a construction of a single leaflet of the present invention;

FIG. 7 (b) is a schematic view of a construction of a part of the leaflet mechanism using the leaflet of FIG. 7 (a);

FIG. 8 is a schematic view of a clip according to the present invention;

FIG. 9 (a) is a diagram of the connection of the inner stent and leaflet mechanism of the present invention;

fig. 9 (b) is a partial enlarged view of fig. 9 (a);

FIG. 10 (a) is a schematic view of a structure of an outer frame suture film of the present invention;

FIG. 10 (b) is a schematic view of a lower skirt seaming film according to the present invention;

FIG. 10 (c) is a schematic view of an inner frame suture film according to the present invention;

FIG. 10 (d) is a schematic structural view of the tie film of the present invention.

Detailed Description

In order that the manner in which the invention is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the invention will be further described in connection with the accompanying drawings.

In the present invention, when describing a mitral valve device, "proximal" refers to the side of the mitral valve device that is located on the side of the transporter or in the direction of the end manipulated by the user, and correspondingly, "distal" refers to the side of the mitral valve device that is located away from the transporter or in the direction of the end manipulated by the user.

In the present invention, when describing a mitral valve device, "axial" refers to a direction between "proximal" and "distal".

Referring to fig. 1 (a) to 5 (c), a mitral valve device includes a stent mechanism 100, the stent mechanism 100 having an outer stent 110 and an inner stent 120 connected to the outer stent 110. The outer stent 110 is a braided stent formed by braiding braided filaments, the braided filaments at the proximal end of the outer stent 110 are braided to the inside with a plurality of outer stent connecting rings 111, and at least the proximal inner diameter of the outer stent 110 is larger than the distal outer diameter of the inner stent 120. The distal end of the inner bracket 120 is provided with a plurality of inner bracket connecting buckles 121, and the inner bracket 120 is hung on the inner side of the outer bracket 110 by adopting a ring buckle connection between the inner bracket connecting buckles 121 and the outer bracket connecting rings 111.

The outer layer support 110 is a woven support formed by weaving woven wires, can be better attached to the inner wall of the heart, and effectively reduces the paravalvular leakage. The outer frame connecting ring 111 is located at the inner side of the proximal end of the outer frame 110, so that the joint of the outer frame 110 and the inner frame 120 adopts an inward bending structure, and can be converted from a single-layer structure to a double-layer structure in the release process of the mitral valve device, so that the compressible diameter of the valve is smaller than that of other double-layer valves, and the advantages of the single-layer frame and the double-layer frame can be considered. In addition, the outer support 110 has at least part of inner diameter larger than the inner support 120, and is connected with the inner support connecting buckle 121 by the outer support connecting ring 111 in a ring buckle manner, and the rest parts except the ring buckle connecting parts are of overhead structures, so that the influence of myocardial motion on the mitral valve device is effectively reduced. The mode of the ring buckle connection ensures that the connection is stable and has a certain degree of freedom, and can also prevent the excessive bending of the connection point of the inner frame and the outer frame in the compression and release process of the mitral valve device.

In some embodiments, referring to FIGS. 2 (a) and 2 (b), the number of outer frame connection rings 111 is N, N.gtoreq.3, and N outer frame connection rings 111 are evenly distributed inside the proximal end of outer frame support 110. As shown in fig. 2 (a), three stent-connecting rings 111 are provided inside the proximal end of the outer stent 110 (i.e., the proximal atrial side of the outer stent 110), and the three stent-connecting rings 111 are uniformly provided in a delta shape along the circumferential inner side of the outer stent 110.

Referring to fig. 4 (a) and 4 (b), the number of the inner frame coupling buckles 121 is the same as that of the outer frame coupling rings 111, and the inner frame coupling buckles 121 are uniformly distributed at the distal ends of the inner frame brackets 120 and are coupled with the outer frame coupling rings 111 in one-to-one correspondence. As shown in fig. 4 (a), three inner frame connectors 121 are provided at the distal end of the inner frame 120 (i.e., the proximal ventricular side of the inner frame 120), and the three inner frame connectors 121 are uniformly arranged in a delta shape along the circumferential direction of the inner frame 120.

In some embodiments, referring to fig. 2 (a) to 2 (c), the braided wires at the proximal end of the outer stent 110 are braided obliquely inward distally to form an invaginated outer stent connecting rod 111a, and an outer stent connecting ring 111 is braided at the distal end of the outer stent connecting rod 111 a.

In some embodiments, the angle between the outer frame connecting rod 111a and the axis of the outer frame support 110 is < 90 °, preferably 15 ° to 75 °, more preferably 30 ° to 60 °.

The inner frame connecting buckle 121 has a straight rod 121a extending distally, and a distal end portion of the straight rod 121a has a ring buckle structure 121b that is engaged with the outer frame connecting ring 111.

The outer frame connecting rod 111a adopts a bending structure, so that the main body part of the outer frame connecting rod is staggered back and forth after being compressed, the outer frame connecting rod can obtain the compression diameter similar to a single-layer bracket while having the advantages of a double-layer bracket, and is suitable for a catheter with smaller diameter.

In some embodiments, referring to fig. 2 (a) to 2 (c), the outer stent 110 includes an outer stent body 112, and the outer stent body 112 has a hollow cylinder-like structure.

In some embodiments, referring to fig. 2 (a) to 2 (c), the distal end of the outer frame body 110 is everted to form a lower skirt 114, the lower skirt 114 being circumferentially distributed along the outer side of the distal end of the outer frame body 110.

In some embodiments, referring to fig. 2 (a) to 2 (c), the proximal end of the outer frame body 110 is turned inside out to form an upper skirt 113, and the upper skirt 113 is uniformly provided with an outer frame connection ring 111 along the inner circumferential direction of the proximal end.

The outer layer bracket 110 is fixed on the atrial side by adopting the upper skirt edge 113, so that reverse extrusion force can be provided, the outer layer bracket 110 is fixed on the ventricular side by adopting the lower skirt edge 114, and the outer layer bracket and the inner wall of the ventricle form a sealing surface by the reverse extrusion force provided by the upper skirt edge 113, so that the perivalvular leakage after the mitral valve device is implanted is reduced.

In some embodiments, the outer frame body 112 is a hollow cylinder-like structure with large proximal and distal diameters and small middle diameter to increase the contact area of the outer frame body 112 with the annulus and reduce paravalvular leakage.

In some embodiments, the upper skirt 113 is a tapered annular structure that increases in diameter from the distal end to the proximal end and then decreases.

In some embodiments, referring to fig. 2 (a) through 2 (e), the lower skirt 114 includes a first everted portion 1141, and the central axis of the outer frame body 112 is at an angle 120 ° < α < 170 °, preferably 110 ° < α < 160 °, to the first everted portion 1141.

In some embodiments, referring to fig. 2 (a) through 2 (e), the lower skirt packet 114 includes a second everted portion 1142, the central axis of the outer frame body 112 being at an angle 10 ° < β < 100 °, preferably 30 ° < β < 95 °, to the second everted portion 1142.

The design of the lower skirt 114 allows the mitral valve device to achieve a better seal at the ventricular end, further avoiding paravalvular leakage.

In some embodiments, the lower skirt 114 may also be of similar design to the upper skirt 113, i.e., the lower skirt 114 is a tapered annular structure with a diameter that increases from the distal end to the proximal end and decreases.

In some embodiments, the upper skirt 113, the outer frame body 112, and the lower skirt 114 are all woven with woven filaments to form a woven stent having a woven mesh. The mesh is a circular, oval, rectangular or diamond mesh to provide the outer frame body 112 with a radially better expandable or contractable purpose.

In some embodiments, the number of woven meshes in the lower skirt 114 is 6N, N being a natural number not less than 1. For example, the number of woven meshes in the lower skirt 114 is 12, 24 or 48.

In some embodiments, the inner frame connecting buckle 121 has a buckle structure, which may be a spring buckle design, and the buckle structure includes a main body 1211 and a rotating arm 1212, one side of the main body 1211 extends to form a hook 1213, and an end of the hook 1213 has a non-return opening; the rotary arm 1212 is pivoted with the other side of the main body 1211 with elastic rotation, and the end of the rotary arm 1212 is provided with a spigot which is in abutting fit with the check mouth to lock the rotary arm 1212 on the hook portion 1213.

When the inner frame connecting buckle 121 is required to be buckled with the outer frame connecting ring 111, the rotating arm 1212 rotates towards the inner side of the hook-shaped part 1213, the spigot is far away from the non-return opening, a gap is reserved for buckling the outer frame connecting ring 111, after the hook-shaped part 1213 hooks the outer frame connecting ring 111, the rotating arm 1212 is released, the rotating arm 1212 rotates, the spigot abuts against the non-return opening, so that the outer frame connecting ring 111 is locked into the hook-shaped part 1213, and the buckle connection between the inner frame connecting buckle 121 and the outer frame connecting ring 111 is completed.

In some embodiments, referring to fig. 4 (a) and 4 (b), the inner bracket 120 includes an inner bracket body 122, the inner bracket body 122 is of a hollow cylindrical structure, and the inner bracket body 122 is uniformly provided with inner bracket connecting buckles 121 along a distal circumferential direction.

In some embodiments, the inner frame body 122 has a mesh structure of a plurality of mesh openings, preferably diamond-shaped openings, such that the inner frame body 122 has the purpose of being radially expandable or collapsible.

In some embodiments, the inner stent 120 is a stent that is cut in one piece from a steel tube, a nitinol tube, or a cobalt chrome tube. The cutting material is not limited to steel pipe, nickel-titanium pipe or cobalt-chromium pipe, and any material which can be implanted into human body can be used. The inner stent 120, which is integrally formed by cutting, has a higher hardness than the outer stent 110, which is woven, so that the influence of myocardial motion on the valve leaflet can be effectively reduced.

In some embodiments, referring to fig. 5 (c), the inner frame body 122 has at least one ring of diamond-shaped mesh frame comprising a number of hollow diamond-shaped frames 1221 and a number of connection blocks 1222. The inner side surface of the diamond 1221 where the vertex angle is located is an arc surface 1223, and the frames between adjacent diamond 1221 are shared. The top corners of two adjacent diamond-shaped frames 1221 are connected in sequence via a connection block 1222 to form a diamond-shaped net rack.

In some embodiments, the inner frame body 122 has at least two diamond-shaped wire racks, adjacent diamond-shaped wire racks being connected in sequence via connection blocks 1222 to form the inner frame body 122.

The inner frame body 122 may be provided with a multi-turn diamond grid according to axial height requirements. As shown in fig. 4 (a), the inner frame body 122 has two rings of diamond-shaped net frames, and the diamond-shaped frames 1221 of adjacent two rings of diamond-shaped net frames share the frame thereof.

In some embodiments, the angle of the apex angle of diamond 1221 in the axial direction is 100 ° to 150 °.

In some embodiments, the outer side of the diamond 1221 at the apex of the proximal or distal end is a rounded surface 1224 that protrudes proximally or distally.

In some embodiments, the inner frame connector 121 is integrally provided on the top corner of the diamond at the distal end of the inner frame body 122. As shown in fig. 4 (a), three inner frame connectors 121 are integrally provided at the top corners of the three diamond-shaped frames at the distal ends, respectively.

In some embodiments, referring to fig. 4 (a), 4 (b) and 5 (b), a plurality of leaflet attachment rods 123 are provided on the inner frame body 122, and the plurality of leaflet attachment rods 123 are uniformly disposed along the distal circumference of the inner frame body 122. Specifically, when set, the leaflet attachment posts 123 are spaced from the inner frame connector 121 at the distal end of the inner frame body 122.

In some embodiments, the leaflet attachment posts 123 are integrally disposed on the top corners of the distally located diamond-shaped frame body 122. As shown in fig. 4 (a), three leaflet attachment rods 123 are integrally provided at the apex angles of the three diamond-shaped frames at the distal ends, respectively. The three leaflet attachment posts 123 are spaced from the three inner frame attachment tabs 121.

In some embodiments, referring to fig. 1 (a) to 1 (c), 9 (a), the mitral valve device further comprises a leaflet mechanism 200, the leaflet mechanism 200 being located inside the inner frame body 122.

Referring to fig. 6 (a) and 6 (b), the leaflet mechanism 200 includes a plurality of leaflets 210, and the plurality of leaflets 210 are sequentially connected to form a valve body with a circular ring structure on the outer circumference, and the middle part of the valve body can be opened and closed unidirectionally.

In some embodiments, referring to fig. 6 (a) to 7 (a), each leaflet 210 includes a leaflet tail 211, a sealing strip 212, and two suture ears 213.

The outer side of the leaflet tail 211 is a protruding structure, and the outer side edge of the leaflet tail 211 is a sewing edge 2111. The inner edge of the sealing strip 212 is a free edge 2121, and the outer side of the sealing strip 212 is integrally connected with the inner side of the leaflet tail 211. The two suture lugs 213 are respectively disposed at two sides of the sealing strip 212, and referring to fig. 7 (b), the suture lugs 213 are folded and embedded with the clips 220 to form a folded structure having a supporting function, and the leaflet 210 is fixed on the leaflet connecting rod 123 along the blood flowing direction by the folded structure. The two adjacent valve leaflets 210 are sequentially connected through a folding structure to form a valve body, the plurality of suture edges 2111 form a circular ring shape and are in suture connection with an inner frame suture film on the inner frame main body 122, and the inner side surface end parts of the free edges 2121 in the two adjacent valve leaflets 210 are contacted to realize unidirectional opening and closing of the middle part of the valve body.

In the design mode of the valve leaflet, the valve leaflet mechanism formed by a plurality of independent valve leaflets 210 has a valve leaflet mechanism with a similar one-way valve function, and the structure is more stable and reliable. The proximal edges of adjacent leaflets 210 are in intimate contact, preventing regurgitation due to incomplete closure. The two suture ears 213 are not connected to the suture membrane, so that the backflow caused by the leakage of blood due to the arrangement of the leaflet holes in the inner frame suture membrane can be effectively prevented.

In some embodiments, referring to fig. 5 (a), the leaflet attachment suture hole 1231 is provided on the leaflet attachment rod 123, and referring to fig. 8, the clip 220 is provided with the clip suture hole 221, and the attachment of the leaflet 210 and the leaflet attachment rod 123 is achieved by the suture connection of the leaflet attachment suture hole 1231 and the clip suture hole 221.

In some embodiments, the leaflet attachment suture holes 1231 employ a waist-shaped hole to facilitate some adjustable space and more suture lines when the leaflet attachment suture holes are sutured with the clip 220 through the clip suture holes 221, increasing fixation stability.

In some embodiments, clip 220 has a thickness of 0.1 millimeters to 0.5 millimeters.

In some embodiments, the design of the leaflet 210 may take the following non-clip 220 configuration:

referring to fig. 7 (a), 9 (a) and 9 (b), each leaflet 210 includes a leaflet tail 211, a sealing strip 212 and two suture ears 213. The outer side of the leaflet tail 211 is a protruding structure, and the outer side edge of the leaflet tail 211 is a sewing edge 2111. The inner edge of the sealing strip 212 is a free edge 2121, and the outer side of the sealing strip 212 is integrally connected with the inner side of the leaflet tail 211. Two sewing lugs 213 are respectively arranged at two sides of the sealing strip 212, and after the sewing lugs 213 pass through the leaflet connecting sewing holes 1231 and turn around the leaflet connecting rod 123, the sewing lugs 213 are in sewing connection with the sealing strip 212 and the adjacent sewing lugs. The two adjacent valve leaflets 210 are sequentially connected through the folded suture ears 213 to form a valve body, the suture edges 2111 form a circular ring shape and are in suture connection with the inner frame suture film on the inner frame main body 122, and the inner side surface end parts of the free edges 2121 in the two adjacent valve leaflets 210 are contacted to realize unidirectional opening and closing of the middle part of the valve body.

In some embodiments, fig. 7 (a), the leaflet 210 further includes a wear strip 214, the wear strip 214 being sutured to the outside of the leaflet tail 211 by stitching.

The design of the anti-abrasion edge strip 214 firstly increases the tearing resistance of the distal end of the valve leaflet 210, secondly reduces the damage to the valve leaflet 210 caused by the friction between the distal end of the valve leaflet 210 and an inner frame suture film on the inner frame main body 122, prolongs the service life of the valve leaflet 210, and the arrangement of the anti-abrasion edge strip 214 is also equivalent to a buffer layer between the valve leaflet 210 and the inner frame suture film, so that the tearing acting force of the valve leaflet 210 to the inner frame suture film in the opening and closing process is effectively buffered, and the service life of the mitral valve device is prolonged.

In some embodiments, referring to fig. 1 (a) to 1 (c), the mitral valve device further comprises a suture membrane mechanism 300, the suture membrane mechanism 300 being wrapped over the stent mechanism 100. The sewing film mechanism 300 includes an outer frame sewing film 310, a lower skirt sewing film 330, an inner frame sewing film 340, and a connection film 350. The outer frame sewing film 310 is fixed to the outer sides of the outer frame main body 112 and the upper skirt 113 by sewing threads; the lower skirt suture film 330 is fixed to the outer side of the lower skirt 114 by suture lines; the inner frame suture film 340 is fixed to the inner side of the inner frame body 122 by a suture; the connection film 350 is connected to the outer frame suture film 310 and the inner frame suture film 340 by suture lines, respectively, so that the suture film mechanism 300 is connected as a whole.

In some embodiments, referring to fig. 10 (a), the outer frame suture film 310 is unfolded in an elongated structure, and the outer frame suture film 310 surrounds the sides of the outer frame body 112 and the upper skirt 113 and covers the sides of the outer frame body 112 and the upper skirt 113; the proximal end of the outer frame suture membrane 310 has a toothed structure 311, which is everted or everted to cover the outer frame connecting rod 111. That is, when the outer frame suture film 310 is positioned at the inner side of the outer frame body 112, the tooth-shaped structure 311 is turned outwards to cover the outer frame connection rod 111a and the outer frame connection ring 111. When the outer frame sewing film 310 is positioned at the outer side of the outer frame main body 112, the tooth-shaped structure 311 is turned inwards to wrap the outer frame connecting rod 111a and the outer frame connecting ring 111.

In some embodiments, referring to fig. 10 (b), the lower skirt stitch film 330 is deployed in an arcuate sheet-like configuration, the lower skirt stitch film 330 wrapping around the lower skirt 114.

In some embodiments, referring to fig. 10 (c), the inner frame suture film 340 is unfolded into an elongated structure, and the inner frame suture film 340 surrounds the side of the inner frame body 122 and is coated on the side of the inner frame body 122; the distal end of the inner frame suture film 340 has a tooth-shaped structure 341, and the tooth-shaped structure 341 is turned out or in to cover the leaflet attachment posts 123 and the inner frame attachment tabs 121 on the inner frame body 122. That is, when the inner frame suture film 340 is positioned at the inner side of the inner frame body 122, the tooth-shaped structure 341 is turned out to cover the leaflet attachment stick 123 and the inner frame attachment buckle 121. When the inner frame sewing film 340 is positioned at the outer side of the inner frame main body 122, the tooth-shaped structure 311 is turned inwards to cover the leaflet connecting rod 123 and the inner frame connecting buckle 121.

In some embodiments, referring to fig. 10 (d), the connection film 350 is unfolded in an arc-shaped sheet structure, and the connection film 350 is wound around between the outer and inner frame bodies 112 and 122 and is sewn to the outer and inner frame bodies 112 and 122, respectively.

In some embodiments, the mitral valve device of the present invention may be delivered into a human body via a delivery channel of a delivery device, wherein during delivery, the inner stent 120 is not positioned inside the outer stent 110, and the outer stent attachment ring 111 of the outer stent 110 is bent proximally back, such that during delivery, a compressed diameter resembling a single stent is obtained, suitable for use with smaller diameter catheters. When the mitral valve device of the present invention is delivered to the target site and gradually released by the delivery device, the lower skirt 114 is in close contact with the inner wall of the ventricle to form a sealing surface, and the upper skirt 113 is in close contact with the inner wall of the atrium to form a supporting surface, thereby better fixing the present invention. At the same time, the outer frame attachment ring 111 is restored, at least the distal end of the outer frame 110 is suspended inside the proximal end of the outer frame 110, and the leaflet mechanism 200 positioned within the inner frame 120 avoids mitral regurgitation.

The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A mitral valve device, comprising:

2. The mitral valve device of claim 1, wherein the number of outer frame connection rings is N, N being greater than or equal to 3, the N outer frame connection rings being evenly distributed inside the proximal end of the outer frame;

the number of the inner frame connecting buckles is the same as that of the outer frame connecting rings, and the inner frame connecting buckles are uniformly distributed at the far end of the inner layer support and are in one-to-one corresponding ring buckle connection with the outer frame connecting rings.

3. The mitral valve device of claim 1, wherein braided wires at a proximal end of the outer stent are braided obliquely inward distal to form an invaginated outer stent connecting rod, the outer stent connecting ring being braided at a distal end of the outer stent connecting rod;

4. The mitral valve device of claim 1, wherein the outer stent comprises:

an outer frame body, a hollow cylinder-like structure.

5. The mitral valve device of claim 4, wherein the distal end of the outer frame body is everted to form a lower skirt that is circumferentially distributed along an outer side of the distal end of the outer frame body.

6. The mitral valve device of claim 5, wherein the proximal end of the outer frame body is inverted to form an upper skirt that is circumferentially uniformly provided with the outer frame attachment ring inboard of the proximal end.

7. The mitral valve device of claim 6, wherein the stent body is a hollow cylinder-like structure with a large proximal and distal diameter and a small middle diameter.

8. The mitral valve device of claim 6, wherein the upper skirt is a tapered annular structure that increases in diameter from the distal end to the proximal end and then decreases.

9. Mitral valve device as claimed in claim 6, characterized in that the lower skirt comprises a first eversion, the central axis of the outer frame body being at an angle of 120 ° < α < 170 °, preferably 110 ° < α < 160 °.

10. Mitral valve device as claimed in claim 9, wherein the lower skirt comprises a second eversion, the central axis of the outer frame body being at an angle of 10 ° < β < 100 °, preferably 30 ° < β < 95 °.

11. The mitral valve device of claim 6, wherein the lower skirt is a tapered annular structure that increases in diameter from the distal end to the proximal end and then decreases.

12. The mitral valve device of claim 6, wherein the upper skirt, the outer frame body, and the lower skirt are each woven with braided filaments to form a braided stent having a braided mesh;

the woven mesh is a circular, elliptic, rectangular or rhombic woven mesh.

13. The mitral valve device of claim 12, wherein the number of woven webs in the lower skirt is 6N, N being a natural number that is not less than 1.

14. The mitral valve device of claim 1, wherein the inner frame connector has a loop structure comprising:

15. The mitral valve device of claim 6, wherein the inner stent comprises:

16. The mitral valve device of claim 15, wherein the inner frame body is mesh-like structure that is radially expandable or collapsible.

17. The mitral valve device of claim 15, wherein the stent body has at least one ring of diamond-shaped mesh frame comprising:

a plurality of hollow diamond-shaped frames, wherein the inner side surface of the diamond-shaped frame, where the vertex angle of the diamond-shaped frame is positioned, is an arc surface;

18. The mitral valve device of claim 17, wherein the stent body has at least two rings of diamond-shaped wire frames, adjacent diamond-shaped wire frames being connected in sequence via the connection block to form the stent body.

19. The mitral valve device of claim 17, wherein an apex angle of the diamond in an axial direction is 100 ° to 150 °.

20. The mitral valve device of claim 17, wherein an outer side of the diamond at which the apex angle of the proximal or distal end is located is a rounded surface that protrudes proximally or distally.

21. The mitral valve device of claim 17, wherein the stent-graft buckle is integrally disposed on a vertex of a distally located diamond in the stent body.

22. The mitral valve device of any one of claims 1 to 21, wherein the inner stent is a stent that is integrally cut from a steel tube, a nitinol tube, or a cobalt chrome tube.

23. The mitral valve device of claim 15, further comprising:

the leaflet mechanism includes:

the valve body with the outer circumference of a circular ring structure is formed by sequentially connecting a plurality of valve leaves.

24. The mitral valve device of claim 23, wherein the inner frame body has disposed thereon:

the leaflets each comprise:

the sealing strip is of a bending structure, the edge of the inner side is a free edge, and the outer side is integrally connected with the inner side of the tail part of the valve leaflet;

25. The mitral valve device of claim 24, wherein the leaflet attachment rod has a leaflet attachment suture hole disposed thereon;

the clamping piece is provided with a clamping piece sewing hole;

26. The mitral valve device of claim 24, wherein the clip has a thickness of 0.1 mm to 0.5 mm.

27. The mitral valve device of claim 23, wherein the inner frame body has disposed thereon:

the leaflets each comprise:

28. The mitral valve device of claim 27, wherein the leaflet further comprises:

29. The mitral valve device of claim 15, further comprising:

the suture membrane mechanism is coated on the bracket mechanism;

the suturing membrane mechanism comprises:

30. The mitral valve device of claim 29, wherein the outer frame suture membrane is deployed in an elongated configuration, the outer frame suture membrane surrounding and wrapping over sides of the outer frame body and the upper skirt;

31. The mitral valve device of claim 29, wherein the lower skirt suture membrane is deployed in an arcuate sheet-like structure, the lower skirt suture membrane wrapping around the lower skirt.

32. The mitral valve device of claim 29, wherein the stent-graft is deployed in an elongated configuration, the stent-graft encircling and wrapping around a side of the stent body;

33. The mitral valve device of claim 29, wherein the connecting membrane is deployed in an arcuate sheet-like configuration, the connecting membrane encircling between and being sutured to the outer frame body and the inner frame body, respectively.