CN118557336B - An artificial heart valve - Google Patents

Abstract

The invention relates to a heart valve prosthesis, which comprises a bracket, a valve skirt and valve leaflets, wherein the bracket comprises a first connector, second connectors, connecting columns, positioning pieces and a sleeve, three first connecting points are arranged at the proximal end of the first connector, three second connecting points are arranged at the distal end of the second connector, the number of the connecting columns is three, the corresponding first connecting points and the second connecting points are connected through one connecting column, and the three connecting columns divide the interval into three connecting areas in the circumferential direction; three connection groups are connected to the first connector, the three connection groups correspond to the three connection areas respectively, and the connection groups comprise two connection structures; the number of the positioning pieces is three, the positioning pieces are long, and two ends of each positioning piece are respectively clamped with two connecting structures of the connecting group; the connecting part of the positioning piece and the connecting structure is also sleeved with a sleeve. When the bracket is assembled, the positioning piece does not need to be twisted, and each part of the bracket can not generate metal fatigue, so that the reliability of the artificial heart valve is ensured.

Description

An artificial heart valve

Technical Field

The present invention belongs to the technical field of medical devices, and in particular relates to an artificial heart valve.

Background Art

Prior art CN116531146A discloses an artificial heart valve that is easy to position, which is provided with an integrated inner frame and an outer frame. When positioning, the native valve is clamped by the outer frame, so that the artificial heart valve can be positioned at a specified position. Since the outer frame and the inner frame are an integrated structure, during manufacturing, the outer frame and the inner frame are formed by laser cutting a tube blank, and the outer frame overlaps the inner frame. That is to say, after the outer frame and the inner frame are cut to form the outer frame and the inner frame, the outer frame needs to be bent to one side of the inner frame so that the outer frame and the inner frame can clamp the native valve. When the outer frame is bent, metal fatigue may be caused at the bending position, and the native valve cannot be effectively clamped when the artificial heart valve is working.

The prior art CN117838385A also discloses a split regurgitant aortic valve stent and its delivery system, which discloses a split positioning piece. During installation, the T-shaped head is inserted into the limiting piece of the stent body. Since the limiting piece is a rectangular groove and the positioning piece is an integral part, that is to say, during installation, three T-shaped heads need to be inserted into the corresponding rectangular grooves in turn and rotated. After one T-shaped head is inserted into the corresponding rectangular groove, its position remains basically unchanged. Therefore, when inserting the second T-shaped head into the corresponding rectangular groove, the T-shaped head needs to be rotated so that the T-shaped head is twisted relative to the positioning piece so that the T-shaped head can be smoothly inserted into the rectangular groove. On the one hand, the difficulty of assembling the positioning piece and the stent body is increased, and twisting the T-shaped head will also cause certain metal fatigue at the T-shaped head, reducing the reliability of the device.

Summary of the invention

In view of this, the present invention provides an artificial heart valve, which adopts a split manner to assemble the stent. When assembling the stent, the positioning piece does not need to be twisted, thereby facilitating the assembly between the positioning piece and the first connector. Since there is no twisting, metal fatigue will not occur in various parts of the stent, thereby ensuring the reliability of the artificial heart valve.

The technical solution adopted by the present invention is:

An artificial heart valve comprises a stent, a valve skirt and a valve leaflet, wherein the stent comprises a first connector, a second connector, a connecting column, a positioning member and a sleeve, wherein the first connector and the second connector are both columnar, the axis of the first connector coincides with the axis of the second connector, a gap is left between the first connector and the second connector, three first connecting points are arranged at a proximal end of the first connector, and the three first connecting points are evenly spaced in the circumferential direction of the first connector, three second connecting points are arranged at a distal end of the second connector, and the three second connecting points are evenly spaced in the circumferential direction of the second connector, and the three first connecting points correspond one to one with the three second connecting points in the axial direction;

The number of the connecting posts is three, and the corresponding first connecting point and the second connecting point are connected by one connecting post, so that the interval is formed between the first connecting body and the second connecting body, and in the circumferential direction, the three connecting posts divide the interval into three connecting areas;

The first connector is connected to three connection groups, the three connection groups correspond to the three connection areas respectively, and the connection groups include two connection structures;

The number of the positioning members is three, and the three positioning members correspond to the three connection groups respectively. The positioning member is in the shape of a long strip, and the two ends of the positioning member are respectively engaged with the two connection structures of the connection group. The middle part of the positioning member forms a clamping part, and the clamping part extends into the position where the second connection body is located, and the clamping part is located radially outside the second connection body;

The sleeve is also sleeved at the connection between the positioning member and the connection structure to prevent the positioning member from loosening from the connection structure;

The petal skirt is wrapped around the second connector, the petal leaf is located radially inside the second connector, the petal leaf is connected to the connecting column, and is circumferentially sewn to the second connector.

Preferably, the connecting structure includes a connecting strip, a first connecting notch is provided on the connecting strip, so that a first bite portion is formed on the connecting strip, and the first bite portion is farther away from the first connecting body than the first connecting notch; a second connecting notch is provided at the end of the positioning member, so that a second bite portion is formed at the end of the positioning member, and the second bite portion is farther away from the center of the positioning member than the second connecting notch; the first connecting notch bites with the second bite portion, and the second connecting notch bites with the first bite portion.

Preferably, the openings of the two first connection ports of the connection group are arranged opposite to each other.

Preferably, the positioning member is U-shaped, the clamping portion is provided with a developing hole, and a developing member is embedded in the developing hole.

Preferably, the first connector, the second connector and the connecting column are an integrated structure and together constitute an inner frame, and the inner frame is formed by laser cutting of a tube, and the tube is a memory alloy tube or a superelastic alloy tube.

Preferably, the positioning member is made of memory alloy or superelastic alloy.

Preferably, in the circumferential direction, the first connecting body is surrounded by a plurality of herringbone-shaped sub-bodies, and a connection point between two adjacent sub-bodies constitutes a first connection point or a third connection point, and the third connection point is used to connect to the connecting structure.

Preferably, the second connecting body is in a grid shape, and in the circumferential direction, the number of the grids is greater than the number of the split bodies.

Preferably, a suture hole is provided on the connecting column, and the leaflet is sutured to the suture hole.

Beneficial effects of the present invention:

In the present invention, the positioning member and the first connector are split structures, and the number of the first positioning members is three. Each single first positioning member is independently clamped with the first connector. When the positioning member is connected to the corresponding connection group, the two ends of the positioning member are respectively clamped with the two connection structures. During the connection process, the positioning member will not be affected by other positioning members, so the positioning member will not be twisted. On the one hand, it makes it easier to clamp with the connection structure. On the other hand, it can also prevent the metal fatigue from inverting and breaking the positioning member. The sleeve is arranged on the outside of the connection, so as to wrap the connection between the positioning member and the connection structure to prevent the two from loosening, ensure that the positioning member and the connection structure are effectively connected together, prevent the positioning member from falling off, ensure that the artificial heart valve can effectively clamp the native leaflet, prevent the heart valve from falling off, and ensure the surgical effect.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

FIG1 is a schematic diagram of the structure of a bracket;

Fig. 2 is a schematic diagram of the structure of the inner frame;

FIG3 is a schematic structural diagram of a positioning member;

FIG4 is a partial enlarged view of the bracket;

FIG5 is a schematic diagram of the structure of an artificial heart valve;

FIG. 6 is a schematic diagram of an artificial heart valve implanted in a native valve.

In the figure: 1, first connector; 2, second connector; 3, connecting column; 4, positioning member; 5, connecting group; 6, sleeve; 7, petal skirt; 8, petal leaf;

21. Grid;

41. Clamping portion; 42. Second connecting notch; 43. Second bite portion; 44. Development hole;

51. connection structure; 52. left connection bar; 53. right connection bar;

521. First connecting notch; 522. First bite portion.

DETAILED DESCRIPTION

The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid confusing the essence of the present invention, known methods, processes, procedures, and components are not described in detail.

In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

Referring to Figures 1 to 6, the present invention provides an artificial heart valve (hereinafter referred to as "heart valve"). During surgery, the heart valve is implanted into the native valve through a delivery system, including a stent, a valve skirt 7 and a valve leaflet. The stent includes a first connector 1, a second connector 2, a connecting column 3, a positioning member 4 and a sleeve 6. The first connector 1 and the second connector 2 are both columnar (in a natural state). The axis of the first connector 1 coincides with the axis of the second connector 2. A gap is left between the first connector 1 and the second connector 2. Three first connection points are provided at the proximal end of the first connector 1. The three first connection points are evenly spaced around the circumference of the first connector 1. Three second connection points are provided at the distal end of the second connector 2. The three second connection points are evenly spaced around the circumference of the second connector 2. In the axial direction, the three first connection points correspond one to one with the three second connection points.

The distal ends of the outflow ends of the first connectors 1 are bent or gathered toward the center of the expandable stent.

The number of the connecting columns 3 is three, and the first connecting point and the second connecting point corresponding to each other in the axial direction are connected via one connecting column 3, so that the gap is formed between the first connecting body 1 and the second connecting body 2. In the circumferential direction, the three connecting columns 3 divide the gap into three connecting areas.

Three connection groups 5 are connected to the first connection body 1 . The three connection groups 5 correspond to the three connection areas respectively. The connection group 5 includes two connection structures 51 .

There are three positioning members 4, and the three positioning members 4 correspond to the three connecting groups 5 respectively. The positioning members 4 are in the shape of long strips, and the two ends of the positioning members 4 are respectively engaged with the two connecting structures 51 of the connecting group 5. A clamping portion 41 is formed in the middle of the positioning member 4, and the clamping portion 41 extends into the position where the second connecting body 2 is located, and the clamping portion 41 is located radially outside the second connecting body 2.

The sleeve 6 is further provided at the connection between the positioning member 4 and the connection structure 51 to prevent the positioning member 4 and the connection structure 51 from being loosened.

The petal skirt 7 is wrapped around the second connector 2, the petal leaf is located radially inside the second connector, the petal leaf is connected to the connecting column, and is circumferentially sewn to the second connector 2.

The heart valve of the present invention is used in conjunction with a heart valve delivery system. Initially, the heart valve is compressed by a special tool and stored in a sheath tube. The heart valve is delivered to the native valve through the sheath tube. When releasing the heart valve, the sheath tube is pulled toward the operator to gradually expose the heart valve, so that the clamping portion 41 of the positioning member 4 is exposed first, and the clamping portion 41 of the positioning member 4 is no longer restricted by the sheath tube. At this time, both ends of the positioning member 4 are restricted in the sheath tube through the connecting group. The positioning member is elastic, and the clamping portion 41 is no longer restricted radially outward. The clamping portion 41 opens radially outward so that the clamping portion 41 is radially away from the second connector 2, thereby forming a clamping space between the clamping portion 41 and the second connector 2, and positioning the native leaflets in the clamping space. The heart valve continues to be released, and the second connector 2 and the first connector 1 are completely released in turn. The first connector 1 and the second connector 2 are unfolded, which reduces the clamping space and generates a certain radial supporting force, so that the positioning member 4 and the second connector 2 clamp the native leaflets, thereby fixing the heart valve at the native valve.

On the heart valve of the present invention, the first connector 1 and the second connector 2 are connected by a connecting column 3. The three are preferably an integral structure. For the convenience of description, the three are called an inner frame. The inner frame and the positioning member 4 are a separate structure. That is, when making a heart valve, the inner frame can be directly cut from a tube, and the positioning member 4 is cut separately. Compared with the integrated type (prior art CN116531146A), bending of the positioning member 4 and the occurrence of metal fatigue of the positioning member 4 are avoided.

There are three positioning members 4 in the present invention, and the three positioning members 4 are respectively connected to the three connecting groups 5. When the positioning members 4 are connected to the corresponding connecting groups 5, the two ends of the positioning members 4 are respectively clamped with the two connecting structures 51. During the connection process, the positioning members 4 will not be affected by other positioning members 4, so the positioning members 4 will not be twisted. On the one hand, it makes it easier for the positioning members 4 to be clamped with the connecting structures 51. On the other hand, it can also prevent the metal fatigue-guided positioning members 4 from breaking, thereby ensuring that the heart valve can effectively clamp the native leaflets, prevent the heart valve from falling off, and ensure the surgical effect.

A gap is formed between the first connector 1 and the second connector 2, and three connecting columns 3 divide the gap into three connecting areas in the circumferential direction. The connecting group 5 is located in the connecting area. Therefore, when the positioning member 4 is connected to the two connecting structures 51 of the connecting group 5, since there is no interlacing between the connecting groups 5 in the circumferential direction, there will be no interlacing between the positioning members 4, thereby avoiding mutual interference between the positioning members 4. In addition, the end of the positioning member 4 is directly engaged with the connecting structure 51, and the connecting structure 51 is located in the gap, so that the connection between the two is also located in the gap. That is, when the two are engaged, the first connector 1 and the second connector 2 will not affect the positioning member 4 and the connecting structure 51, thereby facilitating the engagement between the positioning member 4 and the connecting structure 51.

The sleeve 6 is sleeved on the outside of the connection, thereby covering the connection between the positioning member 4 and the connection structure 51 to prevent the two from loosening, ensuring that the positioning member 4 and the connection structure 51 are effectively connected together to prevent the positioning member 4 from falling off.

After the sleeve 6 is sleeved over the connection, the sleeve 6 can be riveted or welded so that the positioning member 4 and the connection structure 51 are effectively connected together and the sleeve 6 is prevented from being loosened.

The connecting structure 51 includes a connecting strip, which is provided with a first connecting notch 521, so that a first bite portion 522 is formed on the connecting strip, and the first bite portion 522 is farther away from the first connecting body 1 than the first connecting notch 521; a second connecting notch 42 is provided at the end of the positioning member 4, so that a second bite portion 43 is formed at the end of the positioning member 4, and the second bite portion 43 is farther away from the center of the positioning member 4 than the second connecting notch 42; the first connecting notch 521 bites with the second bite portion 43, and the second connecting notch 42 bites with the first bite portion 522.

When the positioning member 4 is connected to the connecting strip, the end of the positioning member 4 is inserted into the first notch of the connecting strip through the second bite portion 43 thereon, and at the same time, the first bite portion 522 on the connecting strip is inserted into the second notch of the end of the positioning member 4, so that the positioning member 4 and the connecting strip are mutually engaged; the first connecting notch and the second connecting notch can be rectangular notches, and the second bite portion 43 and the first bite portion 522 are both rectangular. After the positioning member 4 and the connecting strip are mutually engaged, the positioning member 4 and the connecting strip cannot be separated from each other in the axial direction of the connecting strip; and the sleeve 6 is sleeved on the outside of the connection to prevent the connecting strip and the positioning member 4 from being separated in the radial direction, so that the positioning member 4 and the connecting strip are effectively connected together.

The openings of the two first connection ports of the connection group 5 are arranged opposite to each other.

In the embodiment shown in Figure 2, the connection group 5 includes two connection bars, namely a left connection bar 52 and a right connection bar 53. The left connection bar 52 is on the left, and the right connection bar 53 is on the right. The opening of the first connection notch 521 on the left connection bar 52 faces right, and the opening of the first connection notch 521 on the right connection bar 53 faces left. When the positioning member 4 is connected to the connecting group 5, the positioning member 4 is located as a whole between the two connecting strips, and the positions of the two connecting strips are relatively fixed. The positioning member 4 has a certain elasticity, and the second bite portion 43 on the left end portion of the positioning member 4 faces right. When the left end portion of the positioning member 4 cooperates with the first connecting notch 521 on the left connecting strip 52, the left end portion of the positioning member 4 presses the left connecting strip 52 toward the left, and the position of the left connecting strip 52 remains unchanged, so that the left end portion of the positioning member 4 and the left connecting strip 52 are relatively fixed. Similarly, the right end portion of the positioning member 4 presses the right connecting strip 53 toward the right, and the position of the right connecting strip 53 is fixed, so that the right end portion of the positioning member 4 and the right connecting strip 53 are relatively fixed. In this way, the entire positioning member 4 is fixed relative to the connecting group 5, which is convenient for subsequent fixing of the connection through the sleeve 6.

The positioning member 4 is U-shaped, and the clamping portion 41 is provided with a developing hole 44, in which a developing member is embedded. This facilitates the determination of the position of the artificial heart valve during surgery. The positioning end of the positioning member is provided with a buffer structure, and the buffer structure is arranged in a "V" or "U" or "W" shape; the buffer structure can prevent the positioning member from breaking due to stress concentration after compression loading, and can also reduce the impact of the positioning end on the aortic sinus bottom when the valve is closed and subjected to blood pressure pressure.

In addition, the clamping portion 41 is provided with two strip holes, which are respectively located on both sides of the developing hole 44. When the positioning member 4 is manufactured, a preform is first formed by cutting a tube, and then the preform is shaped to form the positioning member 4. During the shaping, the preform will be deformed. The provision of the strip holes can prevent the positioning member 4 from being broken during the shaping process.

The first connector 1, the second connector 2 and the connecting column 3 are an integrated structure and together constitute an inner frame. The inner frame is formed by laser cutting of a tube, and the tube is a memory alloy tube or a superelastic alloy tube.

The positioning member 4 is made of memory alloy or superelastic alloy.

In the circumferential direction, the first connecting body 1 is surrounded by a plurality of herringbone-shaped sub-bodies, and a connection point between two adjacent sub-bodies constitutes a first connection point or a third connection point, and the third connection point is used to connect to the connecting structure 51 .

All the end points on the proximal side of the first connector 1 are connected to corresponding components (connection columns 3 or connection strips), thereby avoiding the formation of sharp points on the first connector 1 and ensuring the safety of the operation.

The second connector 2 is in a grid shape. In the circumferential direction, the number of grids 21 is greater than the number of the split bodies, and the petal skirt 7 can be sewn to the grids 21 .

After the artificial heart valve is implanted, the blood in the ventricle is pumped into the aorta through the artificial heart valve. The first connector 1 serves as the outflow end of the artificial heart valve. The first connector 1 is surrounded by herringbone-shaped parts, so that its grid size is larger, thereby preventing the first connector 1 from blocking the coronary artery orifice.

In addition, when the artificial heart valve is in a natural state, both ends of the positioning member 4 are connected to the first connecting body 1 , so that the positioning member 4 can be unfolded with the first connecting body 1 , thereby enhancing the elasticity of the first connecting body 1 .

The connecting column 3 is provided with a suture hole, and the valve leaflet is sutured with the suture hole, so that the valve leaflet can be fixed conveniently through the suture hole.

It should be understood that the above-mentioned embodiments are merely illustrative and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will all be included in the scope of the claims of the present invention.

Claims (9)

1. The artificial heart valve is characterized by comprising a bracket, a valve skirt and valve leaflets, wherein the bracket comprises a first connector, a second connector, a connecting column, a positioning piece and a sleeve, the first connector and the second connector are columnar, the axes of the first connector and the second connector are mutually overlapped, a space is reserved between the first connector and the second connector, three first connecting points are arranged at the proximal end of the first connector, the three first connecting points are distributed at equal intervals in the circumferential direction of the first connector, three second connecting points are arranged at the distal end of the second connector, the three second connecting points are distributed at equal intervals in the circumferential direction of the second connector, and the three first connecting points and the three second connecting points are in one-to-one correspondence in the axial direction;

The number of the connecting posts is three, the corresponding first connecting points and the second connecting points are connected through one connecting post, so that the first connecting body and the second connecting body form the interval, and the three connecting posts divide the interval into three connecting areas in the circumferential direction;

three connection groups are connected to the first connector, the three connection groups correspond to the three connection areas respectively, and the connection groups comprise two connection structures;

The number of the positioning pieces is three, the three positioning pieces are respectively in one-to-one correspondence with the three connecting groups, the positioning pieces are in a strip shape, two ends of each positioning piece are respectively clamped with two connecting structures of the connecting groups, a clamping part is formed in the middle of each positioning piece, the clamping part stretches into the position where the second connecting body is located, and the clamping part is located on the radial outer side of the second connecting body;

the sleeve is sleeved at the joint of the positioning piece and the connecting structure so as to prevent the positioning piece from loosening from the connecting structure;

the valve skirt is coated on the second connector, and the valve leaflet is positioned on the radial inner side of the second connector and is sewn on the second connector along the circumferential direction.

2. The prosthetic heart valve of claim 1, wherein the connecting structure comprises a connecting strip with a first connection notch formed therein such that a first bite is formed in the connecting strip, the first bite being further from the first connector than the first connection notch; the end part of the positioning piece is provided with a second connecting notch, so that a second engaging part is formed at the end part of the positioning piece, and the second engaging part is far away from the center of the positioning piece compared with the second connecting notch; the first connection notch is engaged with the second engagement portion, and the second connection notch is engaged with the first engagement portion.

3. The prosthetic heart valve of claim 2, wherein the openings of the two first attachment notches of the attachment group are disposed opposite one another.

4. The prosthetic heart valve of claim 1, wherein the positioning member is U-shaped and the clamping portion is provided with a visualization hole having a visualization member embedded therein.

5. The prosthetic heart valve of claim 1, wherein the first connector, the second connector, and the post are integrally formed and together comprise an inner frame that is laser cut from tubing that is a memory alloy tube or a superelastic alloy tube.

6. The prosthetic heart valve of claim 5, wherein the positioning member is made of a memory alloy or a superelastic alloy.

7. The prosthetic heart valve of any one of claims 1-6, wherein in a circumferential direction the first connector is surrounded by a plurality of chevron-shaped segments, a connection point between two adjacent segments constituting a first connection point or a third connection point for connection with the connection structure.

8. The prosthetic heart valve of claim 7, wherein the second connector is lattice-shaped, the number of lattice being greater than the number of segments in the circumferential direction.

9. The prosthetic heart valve of claim 1, wherein the connector post is provided with suture holes, the leaflet being sewn with the suture holes.