CN114587710B

CN114587710B - Artificial heart valve

Info

Publication number: CN114587710B
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: 2025-08-01
Anticipated expiration: 2042-03-21
Also published as: CN114587710A

Abstract

The present invention provides an artificial heart valve, comprising: leaflets and an annular valve frame, wherein the outer surface of the annular valve frame is provided with N plug-ins, the N plug-ins being evenly distributed in the circumferential direction of the annular valve frame, where N is a natural number not less than 2; the first ends of the N plug-ins are provided with mounting holes, and the N plug-ins are connected to N traction wires through the mounting holes; the leaflets are sutured and fixed to the inner surface of the annular valve frame; when the N traction wires are stretched, the N plug-ins remain in a straight state; when the N traction wires are not stretched, the first ends of the N plug-ins bend in a direction away from the annular valve frame. The embodiments of the present invention, by providing N plug-ins on the annular valve frame and fixing the N plug-ins to the native valve in the human body, can effectively reduce the occurrence of paravalvular leakage and regurgitation.

Description

Artificial heart valve

Technical Field

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

Background

Heart and blood vessel diseases are continuously increased along with the increase of population life, and become a common disease of the elderly. 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, regurgitation and the like, a design of adding a skirt edge is adopted in the design of the artificial heart valve. However, in the related art, the artificial heart valve implanted after the skirt design is added, and the perivalvular leakage and regurgitation are still easy to occur.

Disclosure of Invention

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

To achieve the above object, embodiments of the present invention provide a prosthetic heart valve comprising leaflets and an annular valve frame, wherein,

The surface of the outer side of the annular valve frame is provided with N inserts which 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 N traction wires through the mounting holes;

the leaflet is sutured 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 traction wires unstretched, the first ends of the N inserts are bent in a direction away from the annular flap frame.

As an alternative embodiment, the N inserts include a first insert, a second insert, and a third insert, the shape of the first insert, the shape of the second insert, and the shape of the third insert are adapted, and the size of the first insert, the size of the second insert, and the 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 first traction wire connected by the mounting hole along the first insert, and the N traction wires comprise the first traction wire;

the cutting groove cuts the first drawn wire without drawing the first drawn wire.

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

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

As 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 N inserts are made of memory metal.

As an alternative embodiment, the annular petal holder comprises at least one compression layer consisting of a plurality of diamond shapes or a plurality of hexagons end to end.

As an alternative embodiment, the material of the annular petal holder is cobalt chrome.

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

According to the invention, the annular valve frame is provided with the N plug-ins, and the N plug-ins are fixed on the native valve in the human body, so that the occurrence of perivalvular leakage and regurgitation can be effectively reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the description of the embodiments of the present invention will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort to a person of ordinary skill in the art.

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

FIG. 2 is one of N insert anchoring schematic views of a prosthetic heart valve provided in an embodiment of the present invention;

FIG. 3 is a second schematic illustration of the anchoring of N inserts of a prosthetic heart valve provided by an embodiment of the present invention;

FIG. 4 is a schematic illustration of the structure of another prosthetic heart valve provided in an embodiment of 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 according to an embodiment of the present invention;

FIG. 7 is a schematic diagram of a first card according to an embodiment of the present invention;

fig. 8 is a schematic structural view of a conveying device according to an embodiment of the present invention;

FIG. 9 is a schematic illustration of a delivery process for a prosthetic heart valve provided in 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 petal holder according to an embodiment of the present invention.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Referring to fig. 1, fig. 1 is a schematic structural view of a prosthetic heart valve according to an embodiment of the present invention, as shown in fig. 1, the prosthetic heart valve includes leaflets and an 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-ins 20 are provided with mounting holes 201, and the N plug-ins 20 are connected with N traction wires through the mounting holes 201;

the leaflet is sutured and fixed to the surface of the inner side of the annular leaflet frame 10;

With the N draw wires drawn, the N inserts 20 remain straightened;

with the N traction wires unstretched, the first ends of the N inserts 20 are bent away from the annular valve frame 10.

In this embodiment, by providing 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 prosthetic heart valve.

The N inserts 20 are shown in fig. 2, and the upper drawing in fig. 2 is a case that N traction wires are stretched during the implantation process, and at this time, the N inserts 20 are in a straightened state, and at this time, an operator can implant the prosthetic heart valve into the human body through the delivery device. After the prosthetic heart valve is delivered to the target area, the operator controls the traction wires to loosen the traction wires, at which time 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, and the operator can rotate the annular valve frame 10 according to the positions of the N inserts 20 to adjust, so that 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 traction wires and the N inserts 20 are anchored to the native heart valve in the human body, as shown in the lower diagram in fig. 2.

In addition, the cross-sectional view of the N inserts 20 during the implantation process is shown in fig. 3, the upper left side of fig. 3 shows the native heart valve in the human body, the upper right side of fig. 3 shows the N inserts 20 in a straightened state during the implantation process, the lower left side of fig. 3 shows the N inserts 20 during the implantation process, the operator controls the traction wire to loosen the traction wire, at this time, the first end of the N inserts 20 bends toward the direction away from the annular valve frame 10, the operator can rotate the annular valve frame 10 to adjust the position of the N inserts 20, and the lower right side of fig. 3 shows the artificial heart valve fully anchored on the native heart valve.

Wherein an operator can adjust a single traction wire of the N traction 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 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.

In this embodiment, since the native heart valve in the body is a tricuspid valve, as shown in fig. 5, the number of inserts for the prosthetic heart valve is three to fit the tricuspid valve. As shown in fig. 6, the three inserts can be stably riveted to the three native leaflets within the three insert set.

Wherein 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 implantation in the 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 direction of the first traction wire connected by the first insert 21 along the mounting hole 201, and the N traction wires include the first traction wire;

In the case where the first drawing wire is not drawn, the cutting groove 202 cuts the first drawing wire.

In this embodiment, since the prosthetic heart valve needs to be implanted in the human body for a long period of time, and the first traction wire is used by an operator during the operation, the first traction wire needs to be removed from the body after the use is completed, a cutting groove 202 is provided at the first end of the first insert 21, and the cutting groove 202 cuts off the first traction wire when the first traction wire is not stretched, and the operator removes the first traction wire from the body.

Wherein, as shown in fig. 8, the delivery device 30 of the prosthetic heart valve is shown on the left, and the prosthetic heart valve to be implanted in the body is installed in the outer shell 301 of the delivery device 30, as shown on the right 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 site via the delivery device 30 as shown in the upper left-hand view of fig. 9, at which point the operator operates the delivery device to control the rearward movement of the housing 301 to expose the prosthetic heart valve as shown in the upper-hand view of fig. 9. At this time, the prosthetic heart valve expands and abuts against the inner wall of the blood vessel, as shown in the upper right drawing of fig. 9. At this point, the operator can control the rotation of the annular valve frame 10 to have three inserts for three native valve leaflets in the body, respectively, as shown in the lower left-hand view of fig. 9. After positioning is completed, the operator releases the pull wire, anchors the first ends of the three inserts to the native valve leaflets, and cuts the pull wire through the cut-out slots 202, completing implantation of the prosthetic heart valve.

Wherein the expansion of the prosthetic heart valve as shown in the upper right hand drawing of fig. 9, wherein the operator is required to maintain the tension of the pull wire, the first insert 21 is maintained in a straightened state, as shown in the upper right hand drawing of fig. 10. After the prosthetic heart valve has been expanded, the operator rotates the annular valve frame 10 to enable the three inserts to mate to the three native leaflets. After the process of rotating the annular valve frame 10 is completed, the operator slacks the traction wires, at which time the three inserts bend, as shown in the middle diagram of fig. 10. After the three inserts are anchored to the native valve leaflet, the cutting groove 202 abuts against the pulling wire, and the cutting groove 202 is a sharp groove, so that the pulling wire can be cut off, as shown in the lower view of fig. 10. The pull wire is severed and the operator can simultaneously remove the pull wire and delivery device 30 from the body 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 in a circular or oval shape.

In the present embodiment, the first end of the first insert 21 is rounded or oval, which increases the contact area between the first insert 21 and the native valve leaflet, and can increase the stability after anchoring while reducing interference with the tissue in the body.

As an alternative embodiment, the second end of the first insert 21 is provided with a protrusion 203, and the connection position of the annular flap 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 insert 21 is provided with the protrusion 203, as shown in fig. 7, and the connection position between the annular flap frame 10 and the first insert 21 is provided with the groove 101, as shown in the upper diagram of fig. 11, and the first insert 21 and the annular flap frame 10 can be mounted more stably by abutting between the protrusion 203 and the groove 101, as shown in the lower diagram of fig. 11, so as to avoid displacement deviation.

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

In this embodiment, a wrapping layer is disposed on the first end surface of the first insert 21, and in the anchoring process of the prosthetic heart valve, the first end of the first insert 21 contacts 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 side effects of the first insert 21 on the human body are reduced.

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 possible problems such as inflammation 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 memory metal, so that the inserts can be restored to the original state when the operator releases the traction wire, and are smoothly anchored on the surface of the native valve leaflet.

Wherein, the memory metal material is preferably nickel titanium alloy material.

As an alternative embodiment, the annular valve frame 10 comprises at least one compression layer consisting of a plurality of diamond shapes or a plurality of hexagons end to end.

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

The annular valve frame 10 comprises at least one compression layer and can be also arranged into multiple layers, and the number of layers of the annular valve frame 10 can be adjusted according to specific needs of different human bodies so as to meet the requirements of artificial heart valves with different heights.

As an alternative embodiment, the material of the annular flap frame 10 is cobalt chrome.

In the present embodiment, the material of the annular valve frame 10 is cobalt-chromium alloy, so that the annular valve frame 10 can be restored to the pre-compression configuration after implantation into 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 one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.

Claims

1. An artificial heart valve, comprising: leaflets and an annular valve frame, wherein:

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

The first ends of the N plug-ins are provided with mounting holes, and the N plug-ins are connected to the N traction wires through the mounting holes;

The valve leaflet is sutured and fixed to the inner surface of the annular valve frame;

When the N traction wires are stretched, the N plug-ins remain in a straight state;

When the N traction wires are not stretched, the first ends of the N plug-ins are bent in a direction away from the annular valve frame;

The N plug-ins include a first plug-in, a second plug-in, and a third plug-in, wherein the shape of the first plug-in, the shape of the second plug-in, and the shape of the third plug-in are adapted to each other, and the size of the first plug-in, the size of the second plug-in, and the size of the third plug-in are adapted to each other;

A cutting groove is provided at the first end of the first plug-in, wherein the cutting groove is located in the direction of a first traction wire connected to the mounting hole along the first plug-in, and the N traction wires include the first traction wire;

When the first traction wire is not stretched, the cutting groove cuts the first traction wire.

2 . The artificial heart valve according to claim 1 , wherein the first end of the first plug-in is circular or elliptical.

3. The artificial heart valve according to claim 1, characterized in that a protrusion is provided at the second end of the first plug-in, and a groove is provided at the connection position between the annular valve frame and the first plug-in, and the groove is adapted to the protrusion.

4 . The artificial heart valve according to claim 1 , wherein a wrapping layer is provided on the first end of the first plug-in unit, and the wrapping layer is sutured to the first end of the first plug-in unit.

5 . The artificial heart valve according to claim 4 , wherein the wrapping layer is made of polyethylene terephthalate material.

The artificial heart valve according to claim 1 , wherein the N plug-ins are made of memory metal material.

7. The artificial heart valve according to claim 1, characterized in that the annular valve frame includes at least one compression layer, and the compression layer is composed of a plurality of rhombuses or a plurality of hexagons connected end to end.

8. The artificial heart valve according to claim 7, characterized in that the material of the annular valve frame is cobalt-chromium alloy.