CN117297832A

CN117297832A - Mitral valve device

Info

Publication number: CN117297832A
Application number: CN202210704712.6A
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
Anticipated expiration: 2042-06-21
Also published as: CN117297832B

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; at least the inner diameter of the proximal end of the outer layer bracket is larger than the outer diameter of the distal end of the inner layer bracket, and a plurality of outer frame connecting rods are arranged at the proximal end of the outer layer bracket; the far end of inlayer support is provided with a plurality of inner frame connecting rods, is connected realization inlayer support and outer support's connection through inner frame connecting rod and outer frame connecting rod, and the outer support is all maked somebody a mere figurehead except the inner frame connecting rod on the inlayer support. The inner diameter of the outer stent is larger than that of the inner stent, the outer stent and the inner stent are connected through the outer stent connecting rod, and the outer stent and the inner stent are of an overhead structure except for the connecting rod 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 problems that the existing single-layer support of the artificial mitral valve is easy to generate blood reflux, and the double-layer support is large in diameter after being compressed and inconvenient to convey, and provides 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;

at least the inner diameter of the proximal end of the outer layer bracket is larger than the outer diameter of the distal end of the inner layer bracket, and a plurality of outer frame connecting rods are arranged at the proximal end of the outer layer bracket;

the far end of inlayer support is provided with a plurality of inner frame connecting rods, through the inner frame connecting rod with outer frame connecting rod is connected the realization inlayer support with outer layer support's connection, on the inlayer support except the inner frame connecting rod all the other parts all aerial in outer layer support.

As a preferable scheme, the number of the outer frame connecting rods is N, N is more than or equal to 3, and the N outer frame connecting rods are uniformly distributed at the near end of the outer frame bracket;

the number of the inner frame connecting rods is the same as that of the outer frame connecting rods, and the inner frame connecting rods are uniformly distributed at the far ends of the inner layer brackets and correspond to the outer frame connecting rods one by one.

As a preferable scheme, the outer frame connecting rod is of an inward-folded structure inclined towards the inner side of the far end, and an included angle between the outer frame connecting rod and the axis of the outer frame bracket is smaller than 90 degrees, preferably 15-75 degrees, and more preferably 30-60 degrees;

the inner frame connecting rod is of an outward folding structure inclined towards the outer side of the proximal end, and the outward folding angle of the inner frame connecting rod is identical to the inward folding angle of the outer frame connecting rod, so that the inner frame connecting rod and the outer frame connecting rod can be attached.

As an optimal scheme, be provided with leg joint suture hole on the outer frame connecting rod, also be provided with leg joint suture hole on the inner frame connecting rod, through leg joint suture hole realizes outer frame connecting rod with the inner frame connecting rod carries out suture connection.

Preferably, the outer stent comprises:

The outer frame main body is of a hollow cylindrical structure, and the outer frame connecting rods are uniformly arranged along the circumferential direction of the near end;

and the atrial struts are uniformly arranged along the circumferential direction of the proximal end of the outer frame main body.

Preferably, the distal end of the outer frame body is everted to form a ventricular skirt, the ventricular skirt comprises a first everting part and a second everting part which are connected with each other, and the included angle between the central axis of the outer frame body and the first everting part is 100 degrees < alpha < 170 degrees, preferably 130 degrees < alpha < 150 degrees; the included angle between the central axis of the outer frame main body and the second outward turning part is 60-130 degrees, preferably 80-120 degrees.

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

Preferably, the atrial strut comprises a first strut and a second strut which are symmetrical along the axis, one ends of the first strut and the second strut are respectively connected with the outer frame main body, the other ends of the first strut and the second strut are arc structures which are mutually convergent and connected, and in a use state, an included angle between the proximal arc starting position of the atrial strut and the axis of the outer frame main body towards the proximal end is smaller than 90 degrees, preferably 15 degrees to 75 degrees, more preferably 30 degrees to 60 degrees.

Preferably, the open end of the atrial strut is connected with the outer frame main body, and the first strut and the second strut are arc-shaped rods recessed to the symmetry axis of the atrial strut.

As a preferable scheme, the connecting section connected between the two struts of the atrial strut is an arc section, and a converging card is arranged at the tail end of the arc section, and is round or polygonal.

Preferably, the inner layer bracket comprises:

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

Preferably, the outer frame main body and the inner frame main body are both in a net structure and can be radially expanded or contracted.

As a preferred scheme, the outer frame main body and the inner frame main body are provided with at least one circle of diamond-shaped net frame, and the diamond-shaped net frame comprises:

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.

As a preferable scheme, the outer frame main body and the inner frame main body are respectively provided with at least two circles of diamond-shaped net racks, and the adjacent diamond-shaped net racks are sequentially connected through the connecting blocks to form the outer frame main body or the inner frame main 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.

As a preferable scheme, the outer frame connecting rod and the atrial strut are respectively and integrally arranged on the vertex angles of diamond-shaped frames positioned at the near end in the outer frame main body;

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

Preferably, the number of diamond-shaped frames in each layer in the outer frame main body is 6N, wherein N is a natural number not less than 1.

As a preferable scheme, the outer layer bracket and the inner layer bracket are brackets which are integrally manufactured by cutting steel pipes, nickel-titanium pipes or cobalt-chromium pipes.

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

an atrial strut suture membrane secured to the outer surface of the atrial strut by a suture;

a ventricular skirt suture membrane secured to the outside of the ventricular skirt by a suture;

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

the proximal end of the outer frame suture membrane is provided with a tooth-shaped structure, and the tooth-shaped structure is everted or everted to cover the outer frame connecting rod.

As a preferable scheme, the atrial strut suture membrane is unfolded to be of a strip structure, two ends of the atrial strut suture membrane are provided with horn-shaped suture surfaces, the atrial strut suture membrane surrounds the side surface of the atrial strut and is coated on the side surface of the atrial strut, and at least the end part of the atrial strut is exposed out of the atrial strut suture membrane;

After the atrial strut suture membrane is wrapped around the atrial strut, the horn-shaped suture surfaces at the two ends are overlapped, and the horn-shaped suture surfaces are sutured and fixed with the outer frame suture membrane and the ventricular skirt suture membrane.

Preferably, the ventricular skirt suture membrane is unfolded into an arc-shaped sheet structure, and the ventricular skirt suture membrane is wrapped around the ventricular 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 distal end of the inner frame suture membrane is provided with a tooth-shaped structure, and the tooth-shaped structure is everted or everted to cover the valve leaf connecting rod on the inner frame main body.

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 inner diameter of the outer layer bracket is larger than that of the inner layer bracket, the outer layer bracket and the inner layer bracket are connected through the outer frame connecting rod and the inner frame connecting rod, and the rest parts except the connecting rod part are of overhead structures, so that the influence of myocardial motion on the mitral valve device is effectively reduced.

2. The outer frame connecting rod and the inner frame connecting rod are staggered in the front-back direction of the compressed main body part, so that the outer frame connecting rod and the inner frame connecting rod can have the advantages of a double-layer bracket, obtain the compression diameter similar to that of a single-layer bracket, and are suitable for a catheter with smaller diameter.

3. 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, so that the contact area with the valve ring is increased, and the peripheral leakage of the valve is reduced.

4. The outer support is fixed on the atrial side by adopting an atrial strut structure, so that reverse extrusion force can be provided, the fixing requirement of the mitral valve device is ensured, and the diameter after compression is reduced as much as possible. The tail end of the atrial strut is provided with a converging card which is matched with the conveyer restraint device, so that the stent is released smoothly, and the stent can be recovered when being used for semi-implantation when necessary.

5. The outer layer support is fixed on the ventricular side by adopting a ventricular skirt structure, and the outer layer support and the inner wall of a ventricle form a sealing surface by the reverse extrusion force provided by the atrial strut, so that the perivalvular leakage of the mitral valve device after implantation is reduced. Through the design of the ventricular skirt structure, the structure matched with the mitral valve annulus is formed 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 mitral valve device is directly located on the annulus with the minimum systolic-diastolic deformation, the deformation of the annulus is only 3% of the systole, the deformation is small, and the risk of the mitral valve device falling off is avoided.

Drawings

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

FIGS. 1 (b) and 1 (c) are schematic views of another angular structure of FIG. 1;

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

FIG. 2 is a schematic view of the structure of the present invention in FIG. 1 except for the leaflet mechanism;

FIG. 3 (a) is a schematic view of a bracket mechanism according to the present invention;

fig. 3 (b) is a front view of fig. 3 (a);

FIG. 3 (c) is a top view of FIG. 3 (a);

FIG. 3 (d) is an enlarged view of a portion of FIG. 3 (b);

fig. 3 (e) is a partial enlarged view of fig. 3 (b);

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

fig. 4 (b) is a front view of fig. 4 (a);

FIG. 4 (c) is a top view of FIG. 4 (a);

FIG. 5 (a) is a schematic structural view of an inner stent of the present invention;

fig. 5 (b) is a bottom view of fig. 5 (a);

FIG. 5 (c) is an enlarged partial schematic view of the inner stent;

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 schematic view of a structure of an outer frame suture film of the present invention;

FIG. 9 (b) is a schematic illustration of one construction of an atrial strut suture membrane of the present invention;

FIG. 9 (c) is a schematic view of a ventricular skirt suture membrane according to the present invention;

FIG. 9 (d) is a schematic view of an inner frame suture film according to the present invention;

FIG. 9 (e) is a schematic structural view of a tie film of the present invention;

FIG. 10 is a schematic view of the present invention in a state of being transported in a conveyor;

fig. 11 is a schematic diagram of an application 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 (b), 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. At least the proximal inner diameter of the outer stent 110 is larger than the distal outer diameter of the inner stent 120, and the proximal end of the outer stent 110 is provided with a plurality of outer stent struts 111. The distal end of the inner layer bracket 120 is provided with a plurality of inner frame connecting rods 121, and the inner layer bracket 120 and the outer layer bracket 110 are connected through the inner frame connecting rods 121 and the outer frame connecting rods 111, and the rest parts of the inner layer bracket 120 except the inner frame connecting rods 121 are all overhead on the outer layer bracket 110. When the inner stent 120 is elevated above the outer stent 110, it may be that the distal portion of the inner stent 120 is located inside the proximal end of the outer stent 110.

The inner diameter of at least the proximal end of the outer stent is larger than that of the inner stent, the outer stent and the inner stent are connected through the outer stent connecting rod, and the outer stent and the inner stent are of overhead structures except the connecting rod part, so that the influence of myocardial motion on the valve is reduced.

In some embodiments, referring to FIGS. 4 (a) through 4 (c), the number of outer frame connecting rods 111 is N, N.gtoreq.3, such as 4, 6, 9, etc., with N outer frame connecting rods 111 evenly distributed at the proximal end of outer frame support 110. As shown in fig. 4 (a), three stent connecting rods 111 are provided at the proximal end of the outer stent 110 (i.e., the proximal atrial side of the outer stent 110), and the three stent connecting rods 111 are uniformly provided in a delta shape along the circumferential direction of the outer stent 110.

Referring to fig. 5 (a) and 5 (b), the number of the inner frame connecting rods 121 is the same as that of the outer frame connecting rods 111, and the inner frame connecting rods 121 are uniformly distributed at the distal ends of the inner frame brackets 120. As shown in fig. 5 (a), three inner frame connecting rods 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 connecting rods 121 are uniformly arranged in a delta shape along the circumferential direction of the inner frame 120.

Referring to fig. 3 (a) to 3 (c), the inner frame connecting rods 121 are in one-to-one correspondence with the outer frame connecting rods 111. When in setting, the inner frame connecting rod 121 and the outer frame connecting rod 111 are stacked together to be fixedly connected, and the outer frame connecting rod 111 is stacked on the proximal end side of the inner frame connecting rod 121.

In some embodiments, referring to fig. 4 (a) to 4 (c), the outer frame connecting rod 111 is an inwardly folded structure inclined to the distal inner side, and the angle between the outer frame connecting rod 111 and the axis of the outer frame support 110 is < 90 °, preferably 15 ° to 75 °, more preferably 30 ° to 60 °. Referring to fig. 5 (a) and 5 (b), the inner frame connecting rod 121 has an outwardly folded structure inclined to the outside of the proximal end, and the outer frame connecting rod 111 and the inner frame connecting rod 121 are folded at the same angle to each other so that the inner frame connecting rod 121 and the outer frame connecting rod 111 can be bonded.

The outer frame connecting rod and the inner frame connecting rod are staggered in the front-back direction of the compressed main body part, so that the outer frame connecting rod and the inner frame connecting rod can have the advantages of a double-layer bracket, obtain the compression diameter similar to that of a single-layer bracket, and are suitable for a catheter with smaller diameter.

In some embodiments, the outer frame connecting rod 111 is provided with a bracket connection suture hole 1111, and the inner frame connecting rod 121 is also provided with a bracket connection suture hole 1211, and the outer frame connecting rod 111 and the inner frame connecting rod 121 are connected in a suture manner through the bracket connection suture hole 1111 (1211).

In some embodiments, referring to fig. 4 (a) to 4 (c), the outer stent 110 includes an outer stent body 112 and a number of atrial struts 113. The outer frame body 112 has a hollow cylindrical structure, and the outer frame body 112 is uniformly provided with outer frame connecting rods 111 along the proximal circumferential direction. Specifically, the outer frame body 112 has a net structure of a plurality of mesh holes, preferably diamond-shaped holes, so that the outer frame body 112 has the purpose of being expandable or convergent in the radial direction. A plurality of atrial struts 113 are uniformly disposed circumferentially along the proximal end of the outer frame body 112.

The invention adopts an atrial strut structure for fixing the outer stent on the atrial side, and in a natural state, the free end of the atrial strut 113 is inclined towards the distal end of the outer stent, and after the outer stent is conveyed and implanted in the left heart, the free end of the atrial strut 113 is inclined towards the proximal end of the inner stent, and the deformation of the atrial strut 113 is utilized to generate larger elasticity for the left atrium, which is also called reverse extrusion force in the application.

In some embodiments, referring to fig. 3 (b), 3 (d), 3 (e), 4 (a) through 4 (c), the distal end of the outer frame body 112 is everted to form a ventricular skirt 114, the ventricular skirt 114 comprising a first everting portion 1141 and a second everting portion 1142 connected to each other, the central axis of the outer frame body 112 being at an angle of 100 ° < α < 170 °, preferably 130 ° < α < 150 °, to the first everting portion 1141; the angle β between the central axis of the outer frame body 112 and the second everting portion 1142 is 60 ° to 130 °, preferably 80 ° to 120 °.

The outer layer bracket is fixed on the ventricular side by adopting a ventricular skirt structure, and the outer layer bracket and the inner wall of a ventricle form a sealing surface by the reverse extrusion force provided by the atrial strut, so that the perivalvular leakage of the mitral valve device after implantation 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, referring to fig. 4 (b), the atrial strut 113 includes a first strut 1131 and a second strut 1132 symmetrical along its axis, the ends of the first strut 1131 and the second strut 1132 not connected to the outer frame body are in an arc-shaped structure which is mutually convergent and connected, and in use, an included angle between a proximal arc-shaped starting position of the atrial strut 113 and the axis of the outer frame body 112 toward the proximal end is < 90 °, preferably 15 ° to 75 °, more preferably 30 ° to 60 °. So as to realize better supporting and fixing effect on the atrial side.

In some embodiments, the open end of the atrial strut 113 is connected to the outer frame body 112, and the first strut 1131 and the second strut 1132 are each arc-shaped struts recessed from the symmetry axis of the atrial strut. To ensure the fixing requirement of the mitral valve device and simultaneously reduce the diameter after compression as much as possible.

In some embodiments, the end of the atrial strut 113 faces distally outward and is provided with a converging card 1133, the converging card 1133 being circular or polygonal. The converging card is matched with the conveyor restraint device, so that the stent is released slowly, and the stent can be recovered when being semi-implanted if necessary.

In some embodiments, the connection section between the two struts of the atrial strut 113 is an arc section, and a converging card 1133 is disposed at the end of the arc section, and the converging card 1133 is circular or polygonal. In some embodiments, referring to fig. 5 (a) and 5 (b), the inner stent 120 includes an inner stent body 122, the inner stent body 122 is of a hollow cylindrical structure, and the inner stent body 122 is uniformly provided with inner stent connecting rods 121 along a distal circumferential direction. Specifically, the inner frame body 122 has a net structure of a plurality of mesh holes, preferably diamond-shaped holes, so that the inner frame body 122 has a radially expandable or contractible purpose.

In some embodiments, fig. 5 (c), the outer frame body 112 and the inner frame body 122 each have at least one diamond-shaped mesh frame. Taking the diamond-shaped grid on the inner frame body 122 as an example, the diamond-shaped grid includes a plurality of hollow diamond-shaped frames 1221 and a plurality 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 outer frame body 112 and the inner frame body 122 each have at least two rings of diamond wire mounts, with adjacent diamond wire mounts being connected in sequence via connection blocks 1222 to form the inner frame body 122.

The outer frame body 112 and the inner frame body 122 may be provided with a multi-turn diamond-shaped net frame according to axial height requirements. As shown in fig. 4 (b), the outer frame body 112 has two rings of diamond-shaped racks, and the diamond-shaped frames 1221 of adjacent two rings of diamond-shaped racks share the frame thereof. As shown in fig. 5 (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 outer frame connecting rod 111 is integrally disposed on the top corner of the diamond at the proximal end of the outer frame body 112. As shown in fig. 4 (a), three outer frame connecting rods 111 are integrally provided at the top corners of the three diamond-shaped frames at the proximal ends, respectively.

The inner frame connecting rod 121 is integrally provided on the tip angle of the diamond at the distal end of the inner clip main body 122. As shown in fig. 5 (a), three inner frame connecting rods 121 are integrally provided at the top corners of the three diamond-shaped frames at the distal ends, respectively.

In some embodiments, the atrial struts 113 are integrally disposed on the top corners of the proximally located diamond in the outer frame body 112. The atrial strut 113 may be disposed at the apex of the same diamond as the inner frame connecting rod 121, preferably at the apex of a different diamond. For example, when the atrial strut 113 has a V-shaped structure, both open ends of the atrial strut 113 are integrally provided at the top corners of the diamond-shaped frame at the proximal end of the outer frame body 112, respectively. May be disposed at the apex angle of two adjacent diamond-shaped elements, or at least one diamond-shaped element apart, depending on the size of the atrial strut 113 and the size of the diamond-shaped element. As shown in fig. 4 (a), the open ends of each atrial strut 113 are spaced apart by one diamond and then positioned at the apex angle of the two diamonds at the proximal end. An inner frame connecting rod 121 is provided at the top corners of the spaced diamond-shaped frames. The positions of the atrial strut 113 and the inner frame connecting rods 121 are not limited to the positions and the number in fig. 4 (a), and a plurality of inner frame connecting rods 121 may be provided according to actual conditions.

In some embodiments, referring to fig. 4 (a) and 4 (b), the ventricular skirt 114 adopts the same diamond-shaped lattice structure as the outer frame body 112.

When the ventricular skirt 114 has the first everting portion 1141 and the second everting portion 1142, the ventricular skirt 114 is designed into a diamond-shaped net frame structure, and then is shaped by a mold during heat setting to form a structure with the first everting portion 1141 on the inner side and the second everting portion 1142 on the outer side.

In some embodiments, the number of diamond-shaped elements per layer in the outer frame body 112 is 6N, where N is a natural number not less than 1.

In some embodiments, the outer stent 110 is a cut-and-integral outer stent 110 made from steel tubing, nitinol tubing, or cobalt chrome tubing. The inner layer bracket 120 is an inner layer bracket 120 which is integrally manufactured by cutting a steel pipe, a nickel-titanium pipe or a cobalt-chromium pipe. 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 outer layer stent 110 or the inner layer stent 120 is made into a whole by cutting, and the circumferential deviation of the outer layer stent 110 and the inner layer stent 120 is small.

In some embodiments, referring to fig. 5 (a) 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 rods 123 are spaced from the inner frame attachment rods 121 at the distal end of the inner frame body 122.

In some embodiments, the leaflet attachment post 123 is integrally disposed on the apex angle of the distally located diamond of the inner clip body 122. As shown in fig. 5 (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 rods 123 are spaced from the three inner frame attachment rods 121.

In some embodiments, referring to fig. 1 (a) to 1 (c), 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 sealing strip 212 is that 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 design of the leaflet 210 may take the following non-clip 220 configuration:

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 sealing strip 212 is that 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, clip 220 has a thickness of 0.1 millimeters to 0.5 millimeters.

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 2, the mitral valve device further comprises a suture membrane mechanism 300, the suture membrane mechanism 300 being wrapped over the stent mechanism 100. Suture membrane mechanism 300 includes an outer frame suture membrane 310, an atrial strut suture membrane 320, a ventricular skirt suture membrane 330, an inner frame suture membrane 340, and a connection membrane 350. The outer frame suture film 310 is fixed to the outer side of the outer frame body 112 by a suture; the atrial strut suture membrane 320 is fixed to the outer surface of the atrial strut 113 by a suture; ventricular skirt suture membrane 330 is secured to the outside of ventricular skirt 114 by sutures; 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. 9 (a), the outer frame suture film 310 is unfolded into an elongated structure, and the outer frame suture film 310 surrounds the side of the outer frame body 112 and is coated on the side of the outer frame body 112; 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 111. When the outer frame sewing film 310 is positioned on the outer side of the outer frame main body 112, the tooth-shaped structure 311 turns inwards to cover the outer frame connecting rod 111.

In some embodiments, referring to fig. 9 (b), the atrial strut suture membrane 320 is deployed in an elongated configuration, the atrial strut suture membrane 320 has flared suture surfaces 321 at both ends, the atrial strut suture membrane 320 surrounds the sides of the atrial strut 113 and wraps around the sides of the atrial strut 113, and at least the ends of the atrial strut 113 are exposed from the atrial strut suture membrane 320. After the atrial strut suture membrane 320 is wrapped around the atrial strut 113, the trumpet-shaped suture surfaces 321 at both ends overlap, and the atrial strut suture membrane 320 may be sutured and fixed with the outer frame suture membrane 310 and the ventricular skirt suture membrane 330 via the trumpet-shaped suture surfaces 321. Specifically, in practice, the atrial strut suture membrane 320 only covers a portion of the atrial strut 113 where the atrial strut 113 is connected to the outer frame body 112, and most of the atrial strut 113 is exposed outside the atrial strut suture membrane 320.

In some embodiments, referring to fig. 9 (c), the ventricular skirt stitch membrane 330 is deployed in an arcuate sheet-like configuration, and the ventricular skirt stitch membrane 330 wraps around the ventricular skirt 114.

In some embodiments, referring to fig. 9 (d), 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 membrane 340 has a toothed structure 341, which is everted or everted to cover the leaflet attachment posts 123 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. When the inner frame suture film 340 is positioned on the outer side of the inner frame body 122, the tooth-shaped structure 311 is turned inwards to cover the leaflet attachment rod 123.

In some embodiments, referring to fig. 9 (e), 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, referring to fig. 10, the mitral valve device of the present invention may be delivered into a human body via a delivery channel of an external delivery device, and prior to delivery, the atrial strut 113 is flipped toward the proximal direction of the medial stent 120, the mitral valve device is stretched preloaded into the loader, and the mitral valve device is stretched into a single stent for ease of crimping. During delivery, the end of the atrial strut 113 is configured to removably attach to the delivery device. Referring to fig. 11, after the mitral valve device of the present invention is delivered to the target site and gradually released by the delivery device, the ventricular skirt 114 is tightly attached to the inner wall of the ventricle to form a sealing surface, and the atrial strut 113 is tightly attached to the inner wall of the atrium to form a supporting surface, so as to better fix the mitral valve device provided by the present invention. The leaflet mechanism 200 positioned within the inner frame 120 prevents mitral regurgitation by the inner sides of the free edges 2121 of the leaflets 210 contacting each other when closed.

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:

the outer layer support is characterized in that at least the inner diameter of the proximal end of the outer layer support is larger than the outer diameter of the distal end of the inner layer support, and a plurality of outer frame connecting rods are arranged at the proximal end of the outer layer support;

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

3. Mitral valve device as claimed in claim 1, wherein the outer frame connecting rod is of an invaginated structure that is inclined distally and medially, the angle between the outer frame connecting rod and the axis of the outer frame stent being < 90 °, preferably 15 ° to 75 °, more preferably 30 ° to 60 °;

4. The mitral valve device of claim 1, wherein the outer frame connecting rod is provided with a stent-graft suture hole, and the inner frame connecting rod is also provided with a stent-graft suture hole through which the outer frame connecting rod is sutured to the inner frame connecting rod.

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

6. The mitral valve device of claim 5, wherein the distal end of the stent body is everted to form a ventricular skirt comprising first and second eversions connected to each other, the central axis of the stent body being at an angle of 100 ° < α < 170 °, preferably 130 ° < α < 150 °; the included angle between the central axis of the outer frame main body and the second outward turning part is 60-130 degrees, preferably 80-120 degrees.

7. The mitral valve device of claim 5, wherein the stent body is a hollow cylinder-like structure with a large proximal and distal diameter and a small middle diameter.

8. Mitral valve device as claimed in claim 5, wherein the atrial strut comprises a first strut and a second strut symmetrical along its axis, one end of the first strut and one end of the second strut being connected to the outer frame body, respectively, and the other end of the first strut and the second strut being in an arc-shaped configuration converging towards each other and being connected, in use, at an angle of < 90 °, preferably 15 ° to 75 °, more preferably 30 ° to 60 °, between the proximal arc-shaped starting position of the atrial strut and the outer frame body axis.

9. The mitral valve device of claim 8, wherein the open end of the atrial strut is coupled to the outer frame body, and wherein the first strut and the second strut are each arcuate struts recessed toward an axis of symmetry of the atrial strut.

10. The mitral valve device of claim 9, wherein a connecting segment connecting between two struts of the atrial strut is an arcuate segment and a converging card is disposed at an end of the arcuate segment, the converging card being circular or polygonal.

11. The mitral valve device of claim 5, wherein the inner stent comprises:

12. The mitral valve device of claim 11, wherein the outer frame body and the inner frame body each have a mesh structure that is radially expandable or contractible.

13. The mitral valve device of claim 11, wherein the outer frame body and the inner frame body each have 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;

14. The mitral valve device of claim 13, wherein the outer frame body and the inner frame body each have at least two rings of diamond-shaped wire frames, the adjacent diamond-shaped wire frames being connected in sequence via the connection blocks to form the outer frame body or the inner frame body.

15. The mitral valve device of claim 13, wherein an angle of a vertex of the diamond in an axial direction is 100 ° to 150 °.

16. The mitral valve device of claim 13, 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.

17. The mitral valve device of claim 13, wherein the stent connecting rod and the atrial strut are each integrally disposed on a vertex of a diamond at a proximal end in the stent body;

18. The mitral valve device of claim 13, wherein the number of diamond-shaped elements per layer in the stent body is 6N, wherein N is a natural number that is not less than 1.

19. The mitral valve device of claim 11, further comprising:

the leaflet mechanism includes:

a plurality of valve leaves are sequentially connected to form a valve body capable of opening and closing unidirectionally.

20. The mitral valve device of claim 19, wherein the inner frame body has disposed thereon:

the leaflets each comprise:

21. The mitral valve device of claim 20, wherein the leaflet attachment rod has a leaflet attachment suture hole disposed thereon;

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

22. The mitral valve device of claim 19, wherein the inner frame body has disposed thereon:

the leaflets each comprise:

23. The mitral valve device of claim 20 or 22, wherein the leaflet further comprises:

24. The mitral valve device of claim 11, further comprising:

the suture membrane mechanism is coated on the bracket mechanism;

the suturing membrane mechanism comprises:

a ventricular skirt suture membrane fixed to the outer side of the ventricular skirt at the distal end of the outer frame body by a suture thread;

25. The mitral valve device of claim 24, wherein the outer frame suture membrane is deployed in an elongated configuration, the outer frame suture membrane surrounding and wrapping over a side of the outer frame body;

26. The mitral valve device of claim 24, wherein the atrial strut suture membrane is deployed in an elongated configuration with flared suture surfaces at both ends, the atrial strut suture membrane surrounding and wrapping around sides of the atrial strut, at least an end of the atrial strut being exposed from the atrial strut suture membrane;

27. The mitral valve device of claim 24, wherein the ventricular skirt suture membrane is deployed in an arcuate sheet-like structure, the ventricular skirt suture membrane wrapping around the ventricular skirt.

28. The mitral valve device of claim 24, wherein the stent-graft is deployed in an elongated configuration, the stent-graft encircling and wrapping around a side of the stent body;

29. The mitral valve device of claim 24, 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.