CN114587710A

CN114587710A - Artificial heart valve

Info

Publication number: CN114587710A
Application number: CN202210279525.8A
Authority: CN
Inventors: 蔡涛; 张旭; 吕向东
Original assignee: Kangdi Taike Beijing Medical Technology Co ltd
Current assignee: Kangdi Taike Beijing Medical Technology Co ltd
Priority date: 2022-03-21
Filing date: 2022-03-21
Publication date: 2022-06-07

Abstract

The present invention provides a prosthetic heart valve comprising: the valve comprises valve leaflets and an annular valve frame, wherein N inserts are arranged on the surface of the outer side of the annular valve frame, the N inserts are uniformly distributed in the circumferential direction of the annular valve frame, and N is a natural number not less than 2; the first ends of the N plug-in units are provided with mounting holes, and the N plug-in units are connected with the N traction wires through the mounting holes; the valve leaflets are sewn and fixed on the surface of the inner side of the annular valve frame; under the condition that the N traction wires are stretched, the N plug-in units keep a straightened state; under the condition that the N traction wires are not stretched, the first ends of the N insertion pieces are bent to the direction far away from the annular valve frame. According to the embodiment of the invention, the N plug-in units are arranged on the annular valve frame and are fixed on the native valve in a human body, so that the conditions of perivalvular leakage and backflow can be effectively reduced.

Description

Artificial heart valve

Technical Field

The invention relates to the technical field of medical instruments, in particular to a prosthetic heart valve.

Background

Heart and blood vessel diseases are increasing with the increase of the life of the population, and become common diseases of the old. Implantation of prosthetic heart valves is a common treatment. In the related art, in order to improve the adaptation effect of the implanted artificial heart valve and reduce the problems of perivalvular leakage, reflux and the like, the design of increasing the skirt edge is adopted in the design of the artificial heart valve. However, in the related art, perivalvular leakage and regurgitation are still prone to the occurrence of paravalvular leakage when the prosthetic heart valve is implanted after the skirt design is added.

Disclosure of Invention

The embodiment of the invention provides a prosthetic heart valve, which aims to solve the problem that paravalvular leakage is easy to occur in the related art

To achieve the above object, an embodiment of the present invention provides a prosthetic heart valve, including: valve leaflets and an annular valve frame, wherein,

the surface of the outer side of the annular valve frame is provided with N plug-in units, the N plug-in units are uniformly distributed in the circumferential direction of the annular valve frame, and N is a natural number not less than 2;

the first ends of the N plug-in units are provided with mounting holes, and the N plug-in units are connected with the N traction wires through the mounting holes;

the valve leaflets are sewn and fixed on the surface of the inner side of the annular valve frame;

the N inserts are kept in a straightened state under the condition that the N traction wires are stretched;

with the N pull wires unstretched, first ends of the N inserts are bent away from the annular petal housing.

As an optional implementation, the N inserts include a first insert, a second insert, and a third insert, a shape of the first insert, a shape of the second insert, and a shape of the third insert are adapted, and a size of the first insert, a size of the second insert, and a size of the third insert are adapted.

As an alternative embodiment, the first end of the first insert is provided with a cutting groove, the cutting groove is located in the direction of the mounting hole along the first pull wire connected with the first insert, and the N pull wires include the first pull wire;

the cutting groove cuts the first traction wire when the first traction wire is not stretched.

As an alternative embodiment, the first end of the first insert is provided with a circular or oval shape.

As an optional implementation manner, a protrusion is arranged at the second end of the first plug-in unit, a groove is arranged at the connection position of the annular valve frame and the first plug-in unit, and the groove is matched with the protrusion.

In an alternative embodiment, the first end of the first insert is provided with a wrapping layer, and the wrapping layer is connected with the first end of the first insert in a sewing way.

As an alternative embodiment, the wrapping layer is a polyethylene terephthalate material.

As an alternative embodiment, the material of the N inserts is a memory metal material.

As an alternative embodiment, the annular valve frame comprises at least one compression layer, and the compression layer is composed of a plurality of diamonds or a plurality of hexagons which are connected end to end.

As an alternative embodiment, the material of the annular valve frame is cobalt-chromium alloy.

One of the above technical solutions has the following advantages or beneficial effects:

according to the invention, the N plug-in units are arranged on the annular valve frame and are fixed on the native valve in the human body, so that the perivalvular leakage and reflux can be effectively reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the description of the embodiments of the present invention will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without inventive exercise.

FIG. 1 is a schematic diagram of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 2 is one of N schematic anchoring diagrams of an insert of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 3 is a second schematic anchoring view of N inserts of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 4 is a schematic diagram of another embodiment of a prosthetic heart valve according to the present invention;

fig. 5 is a schematic plan view of a native leaflet provided by an embodiment of the present invention;

FIG. 6 is a schematic plan view of a prosthetic heart valve provided in accordance with an embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a first insert provided in accordance with an embodiment of the present invention;

FIG. 8 is a schematic structural diagram of a conveying apparatus provided in an embodiment of the present invention;

FIG. 9 is a schematic illustration of a delivery process for a prosthetic heart valve provided in accordance with an embodiment of the present invention;

FIG. 10 is a schematic illustration of an insert and pull wire during anchoring provided by an embodiment of the present invention;

fig. 11 is a schematic plan view of an annular valve frame according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring to fig. 1, fig. 1 is a schematic structural diagram of a prosthetic heart valve according to an embodiment of the present invention, and as shown in fig. 1, the prosthetic heart valve includes: the leaflets and the annular valve frame 10, wherein,

the surface of the outer side of the annular valve frame 10 is provided with N inserts 20, the N inserts 20 are uniformly distributed in the circumferential direction of the annular valve frame 10, and N is a natural number not less than 2;

the first ends of the N plug-in units 20 are provided with mounting holes 201, and the N plug-in units 20 are connected with the N traction wires through the mounting holes 201;

the valve leaflets are sewn and fixed on the surface of the inner side of the annular valve frame 10;

under N pull wire tensions, the N inserts 20 remain straightened;

with the N pull wires unstretched, the first ends of the N inserts 20 are bent away from the annular petal housing 10.

In this embodiment, by providing the N inserts 20 on the annular valve frame 10, the N inserts 20 can be fixed on the native heart valve in the human body, thereby reducing the occurrence of paravalvular leakage and regurgitation of the artificial heart valve.

Wherein, the N inserts 20 are shown in fig. 2 during the implantation process, the upper drawing in fig. 2 is the condition that the N traction wires are stretched, and at this time, the N inserts 20 are in the straightened state, and at this time, the operator can implant the artificial heart valve into the human body through the delivery device. After the artificial heart valve is delivered to the target area, the operator controls the pull wire to loosen the pull wire, and the first ends of the N inserts 20 are bent away from the annular valve frame 10 as shown in the middle diagram of fig. 2, so that the operator can rotate the annular valve frame 10 to adjust the position of the N inserts 20, and the N inserts 20 can be better anchored with the native heart valve in the human body. After the adjustment is completed, the operator releases the N pull wires and the N inserts 20 are anchored to the native heart valve in the body, as shown in the bottom view of FIG. 2.

Additionally, a cross-sectional view of the N inserts 20 during implantation is shown in FIG. 3, the top left view of FIG. 3 being a native heart valve in a human body; the top right view of fig. 3 shows the N inserts 20 in their straightened state during implantation of the inserts 20; in fig. 3, the lower left view shows the situation that during the implantation of the N inserts 20, the operator controls the pull wire to loosen the pull wire, and the first ends of the N inserts 20 are bent away from the annular valve frame 10, and the operator can rotate the annular valve frame 10 to adjust the positions of the N inserts 20; the bottom right view in fig. 3 is with the prosthetic heart valve fully anchored to the native heart valve.

Wherein the operator can adjust a single pull wire of the N pull wires to control movement of the single insert.

As an alternative embodiment, as shown in fig. 4, the N inserts 20 include a first insert 21, a second insert 22, and a third insert 23, the shape of the first insert 21, the shape of the second insert 22, and the shape of the third insert 23 are matched, and the size of the first insert 21, the size of the second insert 22, and the size of the third insert 23 are matched.

In the present embodiment, since the native heart valve in the body is a tricuspid valve, as shown in fig. 5, the number of the insertion pieces of the artificial heart valve is three, and the insertion pieces can be fitted to the tricuspid valve. As shown in fig. 6, three inserts fit into three native leaflets within the body, which can be stably riveted over the three native leaflets.

The shape of the first insert 21, the shape of the second insert 22 and the shape of the third insert 23 are adapted, and the size of the first insert 21, the size of the second insert 22 and the size of the third insert 23 are adapted, so that the first insert 21, the second insert 22 and the third insert 23 can achieve the same anchoring effect after being implanted in a body.

As an alternative embodiment, as shown in fig. 7, the first end of the first insert 21 is provided with a cutting groove 202, the cutting groove 202 is located in the mounting hole 201 along the direction of the first pull wire connected with the first insert 21, and the N pull wires include the first pull wire;

the cutting groove 202 cuts the first traction wire while the first traction wire is not stretched.

In this embodiment, since the prosthetic heart valve needs to be implanted in a human body for a long time, the first pull wire is used by an operator in the operation process, and the pull wire needs to be removed from the body after use, the first end of the first plug-in unit 21 is provided with the cutting groove 202, and the cutting groove 202 cuts off the first pull wire when the first pull wire is not stretched, and the operator removes the first pull wire from the body.

Wherein, as shown in fig. 8, the delivery device 30 of the artificial heart valve is shown on the left side, and the artificial heart valve to be implanted into the body is arranged in the shell 301 of the delivery device 30, as shown on the right side of fig. 8. The housing 301 is movable under the control of an operator to expose a prosthetic heart valve mounted within the housing 301. After the delivery device 30 is assembled with the prosthetic heart valve, the operator transports the prosthetic heart valve to the target location via the delivery device 30, as shown in the top left of FIG. 9, whereupon the operator manipulates the delivery device and moves the control housing 301 back to expose the prosthetic heart valve, as shown in the top of FIG. 9. At this time, the prosthetic heart valve expands to abut against the inner wall of the blood vessel, as shown in the upper right drawing of fig. 9. At this time, the operator can control the annular valve frame 10 to rotate, so that the three inserts respectively correspond to the three native valve leaflets in the body, as shown in the lower left of fig. 9. After positioning is completed, the operator releases the pull wires, the first ends of the three inserts are anchored to the native valve leaflets, and the pull wires are cut through the cut-out slots 202, completing implantation of the prosthetic heart valve.

In the process of expanding the prosthetic heart valve as shown in the upper right of fig. 9, the operator needs to keep the pull wire stretched to keep the first insert 21 straight, as shown in the upper view of fig. 10. After the prosthetic heart valve is expanded, the operator rotates the annular valve frame 10 so that the three inserts can fit into the three native leaflets. After the process of rotating the annular valve frame 10 is complete, the operator slackens the pull wires and the three inserts flex as shown in the middle of fig. 10. After all three inserts are anchored to the native leaflet, the cutting groove 202 abuts the pull wire, and the pull wire can be cut due to the sharp groove in the cutting groove 202, as shown in the bottom view of fig. 10. The pull wire is cut off and the operator can remove the pull wire and delivery device 30 out of the body simultaneously to complete implantation of the prosthetic heart valve.

As an alternative embodiment, as shown in fig. 7, the first end of the first insert 21 is provided with a circular or oval shape.

In the present embodiment, the first end of the first insert 21 is formed in a circular or elliptical shape, which increases the contact area between the first insert 21 and the native leaflet, reduces interference with the body tissue, and increases the stability after anchoring.

As an alternative embodiment, the second end of the first insert 21 is provided with a protrusion 203, the connection position of the annular valve frame 10 and the first insert 21 is provided with a groove 101, and the groove 101 is matched with the protrusion 203.

In this embodiment, the second end of the first plug-in unit 21 is provided with a protrusion 203, as shown in fig. 7, and the connecting position of the annular flap frame 10 and the first plug-in unit 21 is provided with a groove 101, as shown in the upper drawing of fig. 11, the first plug-in unit 21 and the annular flap frame 10 can be more stably mounted by abutting the protrusion 203 and the groove 101, as shown in the lower drawing of fig. 11, so that displacement deviation is avoided.

In an alternative embodiment, the first end of the first insert 21 is provided with a wrapping layer, and the wrapping layer is sewn to the first end of the first insert 21.

In the embodiment, the wrapping layer is arranged on the first end surface of the first insert 21, and in the anchoring process of the artificial heart valve, the first end of the first insert 21 is in contact with the native valve leaflet, so that the damage of the first insert 21 to the native valve leaflet tissue can be reduced through the wrapping layer, and the possible human side reaction caused by the first insert 21 can be reduced.

In an alternative embodiment, the wrapping layer is a polyethylene terephthalate material.

In this embodiment, the wrapping layer is made of polyethylene terephthalate, so that the damage of the first insert 21 to the periphery of the native valve leaflet can be reduced to an ideal range, and the possible problems of inflammation and the like can be avoided.

As an alternative embodiment, the material of the N inserts 20 is a memory metal material.

In this embodiment, the N inserts 20 are made of a memory metal material, so that the inserts can be restored to their original state when the operator releases the pull wire, and can be smoothly anchored to the surface of the native leaflet.

The memory metal material is preferably a nickel-titanium alloy material.

As an alternative embodiment, the annular valve frame 10 includes at least one compression layer made up of a plurality of diamonds or hexagons connected end to end.

In this embodiment, the annular valve frame 10 needs to be compressed first in the implantation process, and then expanded to the original size in the target region, and the multiple diamonds or multiple hexagons of the compression layer can achieve this effect, while maintaining the strength of the annular valve frame 10 in the axial direction.

Wherein, annular valve frame 10 includes at least one deck compression layer, also can establish to the multilayer, can adjust the number of piles of annular valve frame 10 according to the specific needs of different human bodies to satisfy the demand to the not co-altitude artificial heart valve.

As an alternative embodiment, the material of the annular valve frame 10 is cobalt-chromium alloy.

In this embodiment, the annular valve frame 10 is made of cobalt-chromium alloy, so that the annular valve frame 10 can be restored to the structure before compression after being implanted in the body.

It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A prosthetic heart valve, comprising: valve leaflets and an annular valve frame, wherein,

under the condition that the N traction wires are not stretched, the first ends of the N insertion pieces are bent to the direction far away from the annular valve frame.

2. The prosthetic heart valve of claim 1, wherein the N inserts include a first insert, a second insert, and a third insert, the first insert having a shape that conforms to a shape of the second insert, the first insert having a size that conforms to a size of the second insert, and the third insert having a size that conforms to a size of the third insert.

3. The prosthetic heart valve of claim 2, wherein the first end of the first insert is provided with a cut-out slot in a direction of the mounting hole along a first pull wire to which the first insert is coupled, the N pull wires including the first pull wire;

4. The prosthetic heart valve of claim 2, wherein the first end of the first insert is provided in a circular or oval shape.

5. The heart valve prosthesis of claim 2, wherein the second end of the first insert is provided with a protrusion, and the annular valve frame is provided with a groove at a position where the annular valve frame is connected with the first insert, wherein the groove is matched with the protrusion.

6. The prosthetic heart valve of claim 2, wherein the first end of the first insert is provided with a wrapping layer, the wrapping layer being sutured to the first end of the first insert.

7. The prosthetic heart valve of claim 6, wherein the wrapping layer is a polyethylene terephthalate material.

8. The prosthetic heart valve of claim 1, wherein the material of the N inserts is a memory metal material.

9. The prosthetic heart valve of claim 1, wherein the annular valve frame comprises at least one compression layer comprised of a plurality of diamonds or a plurality of hexagons end-to-end.

10. The prosthetic heart valve of claim 9, wherein the material of the annular valve frame is cobalt-chromium alloy.