CN216257643U

CN216257643U - Heart valve prosthesis capable of being anchored with autologous valve leaflet

Info

Publication number: CN216257643U
Application number: CN202122397950.0U
Authority: CN
Inventors: 吕世文; 张晓燕; 陈进雄
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2021-09-30
Filing date: 2021-09-30
Publication date: 2022-04-12
Anticipated expiration: 2031-09-30

Abstract

The application relates to the field of medical equipment, in particular to a heart valve prosthesis capable of being anchored with a self-body valve leaflet, which comprises: a valve stent having a preset configuration; and a clamping mechanism having a predetermined configuration; wherein, the proximal end of the clamping mechanism is connected with the valve support, and at least part of the clamping mechanism is attached to the outer side of the valve support; the anchoring ring is connected with the far end of the clamping mechanism in a matching way; when the clamping mechanism is released, the clamping mechanism is positioned at the periphery of the autologous valve leaflet, and the anchoring ring encircles the autologous valve leaflet; when the valve stent is released, the clamping mechanism abuts against the valve stent, and the valve stent radially supports the anchoring ring; the anchoring ring can also curl part of the autologous valve leaflets in the scheme of the application, reduces the influence of native valve leaflet tissues on blood flow after replacement, solves two technical pain points about mitral valve replacement therapy in the prior art, and has good clinical significance.

Description

Heart valve prosthesis capable of being anchored with autologous valve leaflet

Technical Field

The application relates to the field of medical equipment, in particular to a heart valve prosthesis capable of being anchored with a self-body valve leaflet.

Background

From the viewpoint of heart structure, whether the mitral valve or the tricuspid valve has special physiological structure, so that the accurate positioning and fixing of the product are very difficult. The location of the mitral valve, particularly within the heart, and its complex anatomy present significant challenges to mitral valve replacement.

Prior art anchoring techniques have mostly employed radial support of the atrioventricular annulus by the stent. This technique has the disadvantage of easily causing compression of the tissue surrounding the annulus, which tends to cause the stent and the compressed tissue to affect the outflow tract. In a long term, with reduced regurgitation, ventricular atrial pressure is reduced, the heart structure is reconstructed, and the large-size stent can influence the reduction of the size of the valve annulus, so that the internal structure of the heart is influenced.

In addition to this, the anchoring technique is also used to fix the leaflets by implanting a docking device in advance at the leaflets, with the stent being spread inside the docking device. Patent CN109789019A describes a heart valve pair wire loop and system from Edwards Lifesciences. The leaflets and the stent are tightly hooped together by wrapping the docking device around the outside of the leaflets. The stent is fixed in a prominent way, but the anterior lobe is greatly hooped on the stent and the left outflow blood is blocked and is not solved.

Patent CN106255476B describes a system for implanting a heart valve from the company Highlife, comprising: a radially self-expanding tubular body having an inflow end and an outflow end and a protrusion extending from a side surface of the tubular body toward the inflow end; a valve disposed within and attached to the tubular body; a fabric configured to form a pocket between the tubular body and the protrusion; and an elongate outer member arranged to be moved into the pocket and to guide cardiac tissue into the pocket such that the cardiac tissue is located between the tubular body and the elongate outer member. The technical method is also that a clamping piece is placed outside valve leaflets, and then a self-expanding valve is implanted, the clamping piece fixes the bracket at the valve leaflets, and the clamping piece is an 'annular valve', although the annular valve avoids the oppression to the annular tissue, the obstruction to the left outflow tract is not solved.

Patent US20080033541 discloses a method of securing a mitral valve stent to the mitral valve annulus using a stent secured to the stent to impinge against a substantial portion of the left atrium, thereby achieving an anchoring effect. The problem with this design is that the prosthetic mitral valve is subject to large impact forces of up and down displacement during motion, and if the struts are not sufficiently rigid, they are difficult to anchor; however, if the struts are too rigid, atrial tissue is easily damaged.

Patent CN202110076329.6 discloses a transcatheter atrioventricular valve replacement system, which comprises a valve stent, artificial valve leaflets, anchors, a covering membrane and a fixing ring. The fixing ring is a circular ring-shaped structure, can be in a circle or a plurality of circles, is coiled around the chordae tendineae of the mitral valve or the tricuspid valve by adopting a method of implantation through a catheter, and draws the chordae tendineae under each valve leaflet from the periphery to the center. The valve support comprises a body support, an atrium plate surface and a connecting piece. The anchoring piece is a plurality of structures which are connected with the body support and are blunt at the tail end of the atrium side in a reverse bending way, and the anchoring piece can hook the fixing ring to fix the valve support. The technical scheme has the defects that: the fixing ring is implanted into the heart firstly, but the fixing ring and the autologous valve or the valve support implanted later do not have a fixed stress point, so that the fixing ring is difficult to anchor with the autologous valve leaflet and the valve support, the scheme of the fixing ring is lack of practicability in implementation, and the implementation difficulty in clinical operation is very high.

In view of the foregoing, although the above techniques have some clinical success, they are deficient and a new transcatheter heart valve replacement system is needed to solve the above problems.

Disclosure of Invention

The present application has been made in view of the above and other concepts. The primary object of the present application is to overcome some of the problems and deficiencies of the prior art.

In the aspect of application of atrioventricular valve operation, the application aims to provide a heart valve prosthesis capable of being anchored with autologous valve leaflets aiming at a patient with atrioventricular valve lesion and needing interventional therapy, so that the problems that the native valve annulus is pressed by a heart valve replacement system and the outflow tract is blocked by the valve leaflets in the prior art can be solved.

According to an aspect of the present application, there is provided a heart valve prosthesis anchorable with a native leaflet, comprising: a valve stent having a preset configuration; and a clamping mechanism having a predetermined configuration; wherein the proximal end of the clamping mechanism is connected with the valve support, and at least part of the clamping mechanism is attached to the outer side of the valve support; an anchoring ring in mating connection with the distal end of the clamping mechanism; when the clamping mechanism is released, the clamping mechanism is positioned at the periphery of the autologous valve leaflet, and the anchoring ring encircles the autologous valve leaflet; when the valve stent is released, the clamping mechanism abuts the valve stent, and the valve stent radially supports the anchoring ring, which engages the valve stent to effect anchoring with native leaflets and restrict axial movement thereof.

According to an embodiment, the anchoring ring is a closed loop structure or the anchoring ring cooperates with the clamping mechanism to form a closed loop structure.

According to an embodiment, the anchoring ring has a diameter smaller than the diameter of the valve stent; and, the anchoring ring has a diameter smaller than a diameter of the native annulus.

According to one embodiment, the clamping mechanism is released prior to the valve stent, and the distal end of the valve stent is released prior to the proximal end; wherein, when the clamping mechanism and the distal end of the valve support are released, the valve support supports the anchoring ring, the native valve leaflets are clamped between the valve support and the anchoring ring, and the valve support is lifted towards the atrium direction to enable the partial native valve leaflets to be curled.

According to an embodiment, the clamping mechanism has a restrained configuration and a released configuration; when the clamping mechanism is in the limiting state, the clamping mechanism is straightened to be in a linear state; when the clamping mechanism is in a releasing state, the far end of the clamping mechanism turns back towards the atrium direction and drives the anchoring ring to encircle the periphery of the autologous valve leaflet.

According to one embodiment, the valve stent has an atrial fixation portion configured to conform to the shape of the valve annulus physiology; when the valve support is released, the atrium fixing part is supported on the autologous valve annulus and is covered with a membrane, so that paravalvular leakage can be avoided.

According to another embodiment, the valve stent supports the anchoring ring with the native leaflets sandwiched therebetween when the clamping mechanism and the distal end of the valve stent are released, the valve stent is pulled in the atrial direction such that a portion of the native leaflets are crimped, and the atrial fixation portion of the valve stent is further released such that a portion of the native leaflets are crimped between the anchoring ring and the native annulus, the arrangement being such that: in the treatment of mitral valve replacement, because the length of preceding leaflet is longer, traditional replacement art can make preceding leaflet shelter from the left ventricle outflow tract, and it is very big to blood flow influence, and this technical scheme can make partial autologous leaflet curl to shorten the length of preceding leaflet, avoided having sheltered from to the left ventricle outflow tract, fine solution the problem that exists among the prior art, had fine clinical meaning.

According to another embodiment, the clamping mechanism comprises an arc-shaped section and an abutment, the arc-shaped section being fixedly connected with the valve holder and the anchoring ring being fixedly connected with the abutment.

According to one embodiment, the number of gripping means is at least 2.

According to one embodiment, when the clamping mechanism is in the restrained configuration, the arcuate segment is in a linear configuration; and when the clamping mechanism is in the releasing state, the arc-shaped section is restored to the preset state and drives the attaching part to move towards the center direction of the valve support.

According to an embodiment, the valve stent may be a ball-expanded stent or a self-expanding stent.

According to one embodiment, said anchoring ring is substantially sheet-like, thread-like or twine-like.

According to one embodiment, the anchoring ring has a peripheral covering membrane that increases friction with the native leaflets.

Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:

1. most of the traditional valve prostheses rely on radial support of the valve annulus to anchor the prostheses, which can cause compression on the native valve annulus, the anchoring defects of the traditional valve prostheses are obvious, and the existing scheme of utilizing the leaflet anchoring support cannot solve the obstruction influence of the left ventricular outflow tract; utilize fixture to take anchoring ring to the position of autologous valve leaflet below in the embodiment of this application, make its anchoring ring can encircle autologous valve leaflet from autologous valve leaflet's periphery, utilize valve support's radial expansion simultaneously, make valve support anchor on autologous valve leaflet with anchoring ring cooperation, this kind of anchor mode can avoid valve support radial expansion autologous valve annulus by a wide margin, and simultaneously, anchoring ring can also curl partial autologous valve leaflet, reduce native valve leaflet tissue to the influence of blood flow after the replacement, two big technical pain points about mitral valve replacement treatment among the prior art have been solved, and great clinical meaning has.

2. Different from the prior art, in an embodiment of this application, the atrium fixed part is constructed into the form that adapts to valve ring physiological structure, can not only be better avoid the problem of valve week leakage, can also provide the supporting force on the axial direction for the valve support, avoids the valve support to the ventricular direction landing after implanting, has further strengthened anchoring force, also can make the partial autologous leaflet of curling can not the reconversion, shelters from the left ventricle outflow tract.

Embodiments of the present application may realize other beneficial technical effects not listed individually, which other technical effects may be partially described below and which would be expected and understood by those skilled in the art after reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1a and 1b are a schematic overall structure diagram of the valve stent, a clamping mechanism anchoring ring and a schematic structural diagram of the anchoring ring.

Fig. 2 a-2 d are schematic views illustrating the process of entering the mitral valve by the delivery device of the present invention.

Fig. 3a to 3e are schematic views illustrating the operation process of repairing the mitral valve according to the present invention.

The names of the parts indicated by the numbers in the drawings are as follows: 1-valve stent, 11-atrium fixation part, 2-clamping mechanism, 21-arc section, 22-abutting part, 3-anchoring ring, 4-delivery device.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items possible.

The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.

In this application, proximal refers to the end proximal to the operator and distal refers to the end distal to the operator.

In the prior art, the native valve usually fails to work normally in the process of replacing the atrioventricular valve, and the traditional treatment means can cause the whole valve to be in an orifice regurgitation state in the process of replacing, thus causing short operation time and high risk, and possibly causing various diseases.

The specific embodiment is as follows:

as shown in fig. 1a, in the present embodiment, the method includes: a valve stent 1 having a preset configuration; and a clamping mechanism 2 having a preset shape; wherein the proximal end of the clamping mechanism 2 is connected with the valve support 1, and at least part of the clamping mechanism 2 is abutted against the outer side of the valve support 1; an anchoring ring 3, wherein the anchoring ring 3 is matched and connected with the far end of the clamping mechanism 2; when the clamping mechanism 2 is released, the clamping mechanism 2 is positioned at the periphery of the autologous valve leaflet, and the anchoring ring 3 encircles the autologous valve leaflet; when the valve stent 1 is released, the clamping mechanism 2 abuts against the valve stent 1, and the valve stent 1 radially supports the anchoring ring 3, and the anchoring ring 3 is matched with the valve stent 1 to realize anchoring with native valve leaflets and limit axial movement of the native valve leaflets.

According to an embodiment, said anchoring ring 3 is a closed loop structure, as shown in fig. 1b, or said anchoring ring 3 cooperates with said gripping means 2 to form a closed loop structure.

According to an embodiment, the anchoring ring 3 has a diameter smaller than the diameter of the valve stent 1; and, the anchoring ring 3 has a diameter smaller than the native annulus.

According to an embodiment, the anchoring ring 3 has a modulus of elasticity such that the valve stent 1 will expand radially when supporting the anchoring ring 3 radially.

According to one embodiment, the valve stent 1 has an atrial fixation section 11, the atrial fixation section 11 being configured to adapt to the shape of the valve annulus physiology; when the valve support 1 is released, the atrial fixation part 11 is supported on the native valve annulus, and the atrial fixation part 11 is covered, so that paravalvular leakage can be avoided.

As shown in fig. 3a and 3b, the clamping mechanism 2 is released first from the valve stent 1, and the distal end of the valve stent 1 is released first from the proximal end; wherein, when the clamping mechanism 2 and the distal end of the valve support 1 are released, the valve support 1 supports the anchoring ring 3, the autologous valve leaflets are clamped between the valve support 1 and the anchoring ring 3, and the valve support 1 is pulled towards the atrium direction to enable the part of the autologous valve leaflets to be curled, as shown in fig. 3 c.

As shown in fig. 3d and 3e, when the clamping mechanism 2 and the distal end of the valve stent 1 are released, the valve stent 1 supports the anchoring ring 3, the native valve leaflets are clamped between the valve stent 1 and the anchoring ring 3, the valve stent 1 is pulled towards the atrium direction to enable part of the native valve leaflets to be curled, and the atrium fixing part 11 of the valve stent 1 is further released to enable part of the native valve leaflets to be curled between the anchoring ring 3 and the native valve annulus, which is designed to aim at: in the treatment of mitral valve replacement, because the length of preceding leaflet is longer, traditional replacement art can make preceding leaflet shelter from the left ventricle outflow tract, and it is very big to blood flow influence, and this technical scheme can make partial autologous leaflet curl to shorten the length of preceding leaflet, avoided having sheltered from to the left ventricle outflow tract, fine solution the problem that exists among the prior art, had fine clinical meaning.

According to an embodiment, the gripping means 2 have a restrained configuration and a released configuration; when the clamping mechanism 2 is in the limiting configuration, the clamping mechanism 2 is straightened to be in a linear state, as shown in fig. 3 a; when the clamping mechanism 2 is in the releasing state, the far end of the clamping mechanism 2 is folded back towards the atrium direction and drives the anchoring ring 3 to encircle the periphery of the autologous valve leaflet.

According to another embodiment, the clamping means 2 comprise an arc-shaped section 21 and an abutment 22, the arc-shaped section 21 being fixedly connected to the valve holder 1 and the anchoring ring 3 being fixedly connected to the abutment 22.

According to one embodiment, the number of gripping means 2 is 2.

According to one embodiment, when the clamping mechanism 2 is in the restraining configuration, the arcuate section 21 is in a linear configuration; when the clamping mechanism 2 is in the release configuration, the arc-shaped section 21 returns to the preset configuration and drives the abutting portion 22 to move toward the center of the valve holder 1.

According to an embodiment, the valve stent 1 may be a ball-expanded stent or a self-expanding stent.

According to one embodiment, said anchoring ring 3 is substantially sheet-like, filiform or twine-like.

According to one embodiment, the anchoring ring 3 has a peripheral covering membrane that increases the friction with the native leaflets.

According to an embodiment, the heart valve prosthesis further comprises a delivery device 4 for loading, delivering and releasing the heart valve prosthesis, the valve stent 1 and the clamping mechanism 2 are preloaded in a linear state in the delivery device 4, after the delivery device 4 enters the left ventricle, the clamping mechanism 2 and the anchoring ring 3 fixed on the clamping mechanism 2 are released, and the clamping mechanism 2 and the anchoring ring 3 are released at a position below the tips of the native valve leaflets, so that the clamping mechanism 2 can be ensured that the anchoring ring 3 can embrace the native valve leaflets from the periphery of the native valve leaflets during the process of restoring the preset shape, and then the distal end part and the proximal end part of the valve stent 1 and the atrium fixing part 11 are sequentially released, and finally the implantation is completed.

An exemplary procedure for repairing a mitral valve of a heart valve prosthesis that can be anchored to native leaflets according to the first embodiment is as follows:

1. operating the delivery device 4 from the inferior vena cava into the heart, and subsequently operating the delivery device 4 across the atrial septum, as shown in figures 2 a-2 c; continuing to operate the delivery device 4 to bend it to face the orifice of the mitral valve, as shown in fig. 2 d;

2. operating the conveying device 4 to enable the far end of the conveying device to be located at a position below the tip of the autologous valve leaflet, gradually releasing the clamping mechanism 2 and the anchoring ring 3 fixed on the clamping mechanism 2, and enabling the anchoring ring 3 to be located at the periphery of the autologous valve leaflet and to surround the autologous valve leaflet in the process that the clamping mechanism 2 restores the preset shape, as shown in fig. 3 a-3 c;

3. operating the delivery device 4 to release the distal portion of the valve stent 1, as shown in fig. 3d, at which time the valve stent 1 radially expands and supports the anchoring ring 3, pulling the entire delivery device 4 towards the atrium, so that a portion of the native leaflets are crimped in place between the anchoring ring 3 and the native annulus;

4. the delivery device 4 is operated to release the proximal portion of the valve stent 1 until the atrial fixation portion 11 conforms to the native annulus, and then the delivery device 4 is withdrawn, as shown in fig. 3e, completing the implantation.

The foregoing description of the example embodiments of the present application has been presented for the purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration and/or construction disclosed, and obviously many modifications and variations are possible to those skilled in the art in light of the above teaching without departing from the invention. It is intended that the scope and equivalents of the invention be defined by the following claims.

Claims

1. A heart valve prosthesis anchorable to native valve leaflets, comprising: comprises a valve support; and a clamping mechanism having a predetermined configuration;

wherein the proximal end of the clamping mechanism is connected with the valve support, and at least part of the clamping mechanism is attached to the outer side of the valve support;

an anchoring ring in mating connection with the distal end of the clamping mechanism;

when the clamping mechanism is released, the clamping mechanism is positioned at the periphery of the autologous valve leaflet, and the anchoring ring encircles the autologous valve leaflet; when the valve stent is released, the clamping mechanism abuts the valve stent, and the valve stent radially supports the anchoring ring, which engages the valve stent to effect anchoring with native leaflets and restrict axial movement thereof.

2. The heart valve prosthesis anchorable to native valve leaflets of claim 1, wherein the anchoring ring is a closed loop structure or cooperates with the clamping mechanism to form a closed loop structure.

3. A heart valve prosthesis anchorable to native valve leaflets according to claim 1 or 2, wherein the anchoring ring has a diameter smaller than the diameter of the valve stent; and, the anchoring ring has a diameter smaller than a diameter of the native annulus.

4. The heart valve prosthesis anchorable to native valve leaflets of claim 1, wherein the clamping mechanism is released prior to the valve stent and the distal end of the valve stent is released prior to the proximal end;

wherein, when the clamping mechanism and the distal end of the valve support are released, the valve support supports the anchoring ring, the native valve leaflets are clamped between the valve support and the anchoring ring, and the valve support is lifted towards the atrium direction to enable the partial native valve leaflets to be curled.

5. The heart valve prosthesis anchorable to native valve leaflets of claim 1, wherein the clamping mechanism has a constrained configuration and a released configuration;

when the clamping mechanism is in the limiting state, the clamping mechanism is straightened to be in a linear state;

when the clamping mechanism is in a releasing state, the far end of the clamping mechanism turns back towards the atrium direction and drives the anchoring ring to encircle the periphery of the autologous valve leaflet.

6. The heart valve prosthesis anchorable to native leaflets of claim 1, wherein the valve stent has atrial fixation portions configured to conform to the shape of the valve annulus anatomy.

7. A heart valve prosthesis anchorable to native valve leaflets as claimed in claim 6, wherein the clamping means comprises an arcuate section and an abutment, the arcuate section being fixedly connected to the valve stent and the anchoring ring being fixedly connected to the abutment.

8. A heart valve prosthesis anchorable to native valve leaflets as claimed in claim 7, wherein the arcuate segments are in a linear configuration when the clamping mechanism is in the constrained configuration; and when the clamping mechanism is in the releasing state, the arc-shaped section is restored to the preset state and drives the attaching part to move towards the center direction of the valve support.

9. The heart valve prosthesis anchorable to native valve leaflets of claim 1, wherein the anchoring ring is generally sheet-like, wire-like or twine-like.

10. The heart valve prosthesis anchorable to native valve leaflets of claim 1, wherein the anchoring ring has a peripheral covering membrane that increases friction with native valve leaflets.