CN218279885U

CN218279885U - Repair device capable of preventing mitral valve regurgitation

Info

Publication number: CN218279885U
Application number: CN202222044632.0U
Authority: CN
Inventors: 马量; 邹煜; 滕鹏
Original assignee: First Affiliated Hospital of Zhejiang University School of Medicine
Current assignee: First Affiliated Hospital of Zhejiang University School of Medicine
Priority date: 2022-08-04
Filing date: 2022-08-04
Publication date: 2023-01-13
Anticipated expiration: 2032-08-04

Abstract

The application relates to the field of medical equipment, in particular to a repair device capable of preventing mitral regurgitation, which comprises a repair piece, a contraction unit, a sealing unit, an adjusting piece and a fixing piece, wherein the contraction part is anchored on a self valve ring through the fixing piece, the repair piece moves along with the movement of self valve leaflets, the contraction unit comprises a contraction framework and a control wire, the control wire is connected with the contraction framework, and the contraction framework can be contracted by pulling the control wire; the sealing unit comprises a core wire, an adaptive sealing membrane and a filler patch, wherein the core wire is configured to adapt to the shape of the autologous valve annulus, the filler patch is positioned at the autologous valve leaflet boundary after the repair device is installed in place, and the adaptive sealing membrane conforms to and abuts against atrial wall tissue; the traction part is an elastic piece, one end of the traction part is fixedly connected with the repair sheet, and the other end of the traction part is fixed on the papillary muscle.

Description

Repair device capable of preventing mitral valve regurgitation

Technical Field

The present application relates to the field of medical devices, and more particularly, to a prosthetic device for preventing mitral regurgitation.

Background

The mitral valve is located at the left atrioventricular orifice and is composed of five parts, an annulus, leaflets, chordae tendineae, papillary muscles, and an interfacing junction, which are anatomically known by the exact name mitral valve device (mitragrapparatus) or mitral valve complex (mitralcomplex).

Mitral regurgitation (mitralregorgement) can be classified into the following two categories: 1. the regurgitation of the rheumatic mitral valve of the heart, mainly caused by mitral insufficiency, can cause the reverse flow of blood, thus mixing different blood and causing the reduction of the blood pumping and oxygen delivery functions of the heart. 2. Non-rheumatic mitral regurgitation, in addition to rheumatic valvular lesions, is commonly referred to as mitral regurgitation to varying degrees due to abnormalities in the mitral valve itself and its surrounding anatomy. The causes of non-rheumatic mitral insufficiency are many, and the common causes are: mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, calcification of the valve annulus, congenital valve malformations, infectious endocarditis, and the like. Mitral regurgitation can also be classified into three types, functional, degenerative or mixed. Most common are degenerative and functional mitral regurgitation. Functionality is generally secondary to impaired left ventricular wall motor function, left ventricular dilatation, papillary muscle dysfunction, commonly found in heart failure patients. This fraction also included ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the structure of the valve, or a pathological change in the structure under the valve, including abnormal extension or rupture of the chordae tendineae.

Conventional treatment of mitral valve regurgitation includes medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Among the surgical methods are mitral valve, tricuspid valve replacement, and mitral valve, tricuspid valve repair. With pure mitral regurgitation, only 30% of patients need mitral valve replacement, and the rest only need mitral valve repair. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. In order to reduce the risk of surgery, transcatheter invasive replacement and repair procedures have been developed.

Patent CN2014103225948 discloses a prosthesis for preventing valve regurgitation, comprising a fixing unit, a connecting element and a repairing sheet, the fixing unit comprising a fixing element and an anchoring element, the connecting element being flexible, a distal portion thereof being connected to a proximal portion of the fixing element, a proximal portion thereof being connected to a distal portion of the repairing sheet, the fixing element being fixed to the atrial wall or annulus of a patient by the anchoring element, the fixing element having a deployed width of less than 2/3 of the circumference of the valve tissue ring, the repairing sheet being located between the native leaflets of the patient in a free state, the maximum width of the repairing sheet being less than the deployed maximum width of a single native leaflet, and the proximal end of the anchoring element being provided with a detachment prevention end. Because the size of the diseased valve is greatly enlarged compared with the size before the disease, the distance between the adjacent valve leaflets is greatly enlarged, the prosthetic flap can not be effectively combined with the adjacent valve leaflets after being implanted, and particularly gaps are easy to appear in the junction area of the autologous valve leaflets, so that the blood backflow is caused.

In summary, in the repair patch in the prior art, due to the expansion of the valve annulus caused by the valve lesion, the distance between the anterior leaflet and the posterior leaflet is enlarged, the repair patch cannot be well combined with the anterior leaflet after being implanted, and particularly, a gap is more likely to occur in the boundary area of the autologous leaflets, so that the blood is refluxed.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

One of the objectives of the present application is to overcome the deficiencies of the prior art, for example, in the prior art, the prosthetic device is not well aligned with the anterior leaflet after implantation due to the expansion of the valve annulus caused by the valve lesion, and the prosthetic device is more easily gapped in the boundary area of the native leaflets, resulting in regurgitation of blood.

According to an aspect of the present application, there is provided a repair device for preventing mitral regurgitation, comprising a repair sheet, a contraction unit, a sealing unit, an adjustment member and a fixation member, wherein the contraction unit is anchored to a native valve annulus by the fixation member, the repair sheet moves along with the movement of native valve leaflets, the contraction unit comprises a contraction skeleton and a control wire, the control wire is connected with the contraction skeleton, and the contraction skeleton can be contracted by pulling the control wire; wherein the sealing unit comprises a core wire, an adaptive sealing membrane, and a filler patch, the core wire configured to conform to the morphology of the native annulus, and the filler patch being located at the native leaflet interface after the prosthetic device is installed in place, the adaptive sealing membrane conforming to and abutting atrial wall tissue; wherein, the traction part is an elastic piece, one end of the traction part is fixedly connected with the repairing sheet, and the other end of the traction part is fixed on the papillary muscle.

According to an embodiment, the self-adapting sealing membrane is fixedly connected with the core wire, the self-adapting sealing membrane is flexible, and the self-adapting sealing membrane can conform to and abut against the atrial wall to form a seal under back pressure or backflow of blood.

According to one embodiment, the patches are made of biological tissue or fabric and are disposed on both left and right sides of the prosthetic sheet, the patches being located at native leaflet boundaries after the prosthetic device is in place.

According to an embodiment, the core wire is arranged in an arc-shaped structure and the core wire is rigid to provide a supporting force for the repair patch.

According to one embodiment, the predetermined configuration of the contracting skeleton matches the shape of the native valve annulus, and the contracting skeleton is made of a rigid material having elasticity, and the contracting skeleton can contract and relax correspondingly following the beating of the heart in the contracting configuration.

According to an embodiment, the control wire is a slender component, one end of the control wire is fixed with the shrinkage framework, and the shrinkage framework can be driven to shrink by pulling the other end of the control wire.

According to an embodiment, when the contraction part is converted from the predetermined configuration to the contracted configuration, the circumference of the contracted skeleton is gradually reduced and drives the circumference of the native valve annulus to be gradually reduced.

According to one embodiment, the prosthetic sheet is provided with an arch-shaped framework, wherein the far ends of the pulling parts are respectively fixed on the left side and the right side of the arch-shaped framework, the near ends of the pulling parts are fixed on papillary muscles, and when the prosthetic sheet moves along with the autologous valve leaflets and the arch-shaped framework turns over, the stroke of the pulling parts is changed along with the movement of the prosthetic sheet.

According to one embodiment, when the prosthetic patch is twisted by blood flow impact, the stroke of the pulling part is changed, and the pulling part can enable the prosthetic patch to return to the initial position.

According to one embodiment, the traction part is a wire-like member and the proximal end of the traction part is provided with barbs, the traction part wrapping around the papillary muscles when the prosthesis is implanted.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

1. because the valve regurgitation lesion can cause the expansion of the valve annulus, the existing repair sheet can only repair prolapsed native valve leaflets and can prevent the regurgitation of blood to a certain extent, but the expanded valve annulus increases the distance between the valve leaflets, so that the repair sheet is difficult to be combined with the adjacent valve leaflets after being implanted, and particularly, the valve leaflet boundary is easy to regurgitate after the distance between the valve leaflets is enlarged; according to an idea of the application, the contraction part can contract the autologous valve ring after expansion, the size of the autologous valve ring can be restored to the shape before valve lesion, the repairing piece is further utilized to be combined with the adjacent autologous valve leaflets, the regurgitation is reduced, the repairing device is provided with the filling piece and the self-adaptive sealing membrane, the self-adaptive sealing membrane can be attached to the atrial wall under the back pressure or impact of blood to seal the gap between the contraction part and the cardiac tissue, meanwhile, the filling piece is arranged at the valve leaflet boundary, and the valve leaflet boundary can be filled with the blood backflow prevention.

2. Different from the prior art, according to one concept of the application, the control wire is pulled to enable the contraction framework to drive the autologous valve ring to contract together, so that the size of the autologous valve ring is reduced, the distance between the adjacent autologous valve leaflets is shortened, and the coaptation area between the repair sheet and the adjacent autologous valve leaflets is increased conveniently after the repair sheet is implanted.

3. In the prior art, when the repair patch is flushed by blood flow, the repair patch cannot be adjusted in real time according to the direction of the blood flow and the impact force, so that the repair patch is not uniformly stressed in each area, is overturned, and is easy to cause the problems of stress fatigue, fiber tearing and the like; according to an idea of the application, work as when repair piece follows autologous valve leaf motion, arch skeleton takes place certain deflection to pulling tractive portion, because tractive portion is the elastic component, make it have the power of reply after being pulled, make its arch skeleton can reply the form position when taking place to deflect in place, effectively avoid repairing the piece and take place the upset, and can effectively retrain repair piece's position, make it when accepting blood and strike, each position atress is even, avoid the long-time concentrated atress in certain region, produce stress fatigue or even fibre tear, the palirrhea effect of influence treatment.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above-mentioned 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 to 1c are a schematic view of the overall structure of the prosthetic device of the present invention and a schematic view of the contraction unit.

Fig. 2 a-2 c are schematic views showing the process of the travel of the adjustment member of the present invention varying with the movement of the prosthetic sheet and the fixation of the prosthetic device in the heart.

The figures in the drawings refer to the following features:

1-repairing piece, 2-shrinking unit, 21-shrinking skeleton, 22-control wire, 23-arched skeleton, 3-sealing unit, 31-core wire, 32-self-adaptive sealing film, 33-repairing piece, 4-adjusting piece, 41-barb and 5-fixing piece.

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.

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, the term "proximal" or "proximal" refers to the end or side closer to the apex of the heart, and "distal" or "distal" refers to the end or side farther from the apex of the heart.

One of the objects of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems.

Example one

As shown in fig. 1a and 1b, a repair device for preventing mitral valve regurgitation according to an embodiment of the present application is illustrated, which comprises a repair sheet 1, a contraction unit 2, a sealing unit 3, an adjusting member 4 and a fixing member 5, wherein the contraction unit 2 is anchored on a native valve annulus by the fixing member 5, the repair sheet 1 moves along with the movement of the native valve leaflets, the contraction unit 2 comprises a contraction skeleton 21 and a control wire 22, the control wire 22 is connected with the contraction skeleton 21, and the contraction skeleton 21 is contracted by pulling the control wire 22; wherein the sealing unit 3 comprises a core wire 31, an adaptive sealing membrane 32 and a filler patch 33, the core wire 31 is configured to adapt to the morphology of the native annulus, and, after the prosthetic device is in place, the filler patch 33 is located at the native leaflet interface, the adaptive sealing membrane 32 conforms to and abuts against the atrial wall tissue; wherein, the adjusting component 4 is an elastic component, one end of the adjusting component 4 is fixedly connected with the repairing piece 1, and the other end of the adjusting component 4 is fixed on the papillary muscle.

In this embodiment, the adaptive sealing membrane 32 is fixedly connected to the core wire 31, as shown in fig. 1a, the adaptive sealing membrane 32 is flexible, and the adaptive sealing membrane 32 can conform to and seal against the atrial wall under the back pressure or reflux of blood.

In this embodiment, the patches 33 are made of biological tissue or fabric, and the patches 33 are disposed on both left and right sides of the prosthetic sheet 1, and the patches 33 are located at the native leaflet interfaces after the prosthetic device is mounted in place.

In this embodiment, the core wire 31 is disposed in an arc structure, and the core wire 31 is rigid to provide a supporting force for the prosthetic patch 1.

In this embodiment, the predetermined shape of the contracted skeleton 21 is matched with the shape of the native valve annulus, as shown in fig. 1c, and the contracted skeleton 21 is made of a rigid material with elasticity, and the contracted skeleton 21 can contract and relax correspondingly following the beating of the heart in the contracted shape.

In this embodiment, the control wire 22 is a slender member, one end of the control wire 22 is fixed to the contraction skeleton 21, and pulling the other end of the control wire 22 can drive the contraction skeleton 21 to contract.

In this embodiment, when the contraction unit 2 is converted from the predetermined configuration to the contracted configuration, the circumference of the contracted skeleton 21 is gradually reduced and drives the circumference of the native valve annulus to gradually decrease.

In this embodiment, the prosthesis 1 is provided with an arched frame 23, as shown in fig. 1a, wherein the distal ends of the adjustment members 4 are fixed to the left and right sides of the arched frame 23, respectively, and the proximal ends of the adjustment members 4 are fixed to papillary muscles, so that when the prosthesis 1 moves along with the native leaflets and the arched frame 23 is inverted, the stroke of the adjustment members 4 is changed along with the movement of the prosthesis 1, as shown in fig. 2a and 2 b.

In this embodiment, when the prosthesis 1 is twisted by blood flow impact, the stroke of the adjustment member 4 is changed, and the adjustment member 4 can return the prosthesis 1 to the initial position.

In this embodiment, the adjustment member 4 is a wire-like member, and the proximal end of the adjustment member 4 is provided with barbs 41, so that when the prosthesis 1 is implanted, the adjustment member 4 is wound around the papillary muscle, as shown in fig. 2 c.

An exemplary procedure for repairing a mitral valve using the prosthetic sheet 1 for mitral regurgitation of the first embodiment is as follows:

1. the repair system is accessed from the apex of the heart and passes through the left ventricle of the patient to reach the position of the left atrium;

2. the contraction unit 2 is delivered to the native valve annulus of the patient by the delivery system, the contraction unit 2 is firstly anchored at the native valve annulus through the fixing piece 5, and then the control wire 22 is operated to make the contraction framework 21 contract;

4. further manipulation of the adjustment member 4 causes the proximal end of the adjustment member 4 to be anchored to the papillary muscle, as shown in fig. 2 c;

5. when the autologous valve is opened and closed, the repair sheet 1 swings along with the movement of the autologous valve leaflets, and meanwhile, the repair sheet 1 is attached to the adjacent autologous valve leaflets, so that the blood circulation between the left atrium and the left ventricle is avoided.

The foregoing description of the above-described 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, configurations and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the following claims.

Claims

1. A repair device capable of preventing mitral regurgitation, comprising a repair sheet, a contraction unit, a sealing unit, an adjustment member and a fixing member, wherein the contraction unit is anchored on a native valve annulus by the fixing member, the repair sheet moves along with the movement of the native valve leaflets, and the repair device is characterized in that: the contraction unit comprises a contraction framework and a control wire, the control wire is connected with the contraction framework, and the contraction framework can be contracted by pulling the control wire; wherein the sealing unit comprises a core wire, an adaptive sealing membrane, and a filler patch, the core wire configured to conform to the morphology of the native annulus, and the filler patch being located at the native leaflet interface after the prosthetic device is installed in place, the adaptive sealing membrane conforming to and abutting atrial wall tissue; wherein, the adjusting piece is an elastic piece, one end of the traction part is fixedly connected with the repairing sheet, and the other end of the traction part is fixed on the papillary muscle.

2. The prosthetic device for preventing mitral regurgitation as claimed in claim 1, wherein: the self-adaptation seal membrane with core silk fixed connection, the self-adaptation seal membrane is flexible, and, the self-adaptation seal membrane can be complied with and paste the atrium wall in order to form sealedly under the back pressure or the backward flow of blood.

3. The prosthetic device for preventing mitral regurgitation as claimed in claim 1, wherein: the patches are made of biological tissue or fabric and are disposed on both left and right sides of the prosthetic sheet, the patches being located at the native leaflet interface after the prosthetic device is in place.

4. The prosthetic device of claim 1, wherein the prosthetic device is configured to prevent mitral regurgitation by: the core wire is arranged in an arc-shaped structure, and the core wire is rigid to provide supporting force for the repairing piece.

5. The prosthetic device of claim 1, wherein the prosthetic device is configured to prevent mitral regurgitation by: the predetermined shape of the contracting framework is matched with the shape of a native valve ring, and the contracting framework is made of rigid materials with elasticity, and the contracting framework can contract and relax correspondingly along with the beating of the heart in the contracting configuration.

6. The prosthetic device for preventing mitral regurgitation as claimed in claim 5, wherein: the control wire is a slender component, one end of the control wire is fixed with the contraction framework, and the other end of the control wire is pulled to drive the contraction framework to contract.

7. The prosthetic device for preventing mitral regurgitation as claimed in claim 5, wherein: when the contraction unit is converted from the preset shape to the contraction shape, the circumference of the contraction framework is gradually reduced and drives the circumference of the autologous valve annulus to be gradually reduced.

8. The prosthetic device for preventing mitral regurgitation as claimed in claim 1, wherein: the repairing sheet is provided with an arched framework, wherein the far ends of the traction parts are respectively fixed on the left side and the right side of the arched framework, the near ends of the traction parts are fixed on papillary muscles, and when the repairing sheet moves along with the autologous valve leaflets and the arched framework is overturned, the stroke of the traction parts is changed along with the movement of the repairing sheet.

9. The prosthetic device of claim 8, wherein the prosthetic device is configured to prevent mitral regurgitation by: when the repairing piece is twisted by blood flow impact, the stroke of the traction part is changed, and the traction part can restore the repairing piece to the initial position.

10. A prosthetic device for preventing mitral regurgitation according to claim 1 wherein: the traction part is a linear member, and the proximal end of the traction part is provided with a barb, and the traction part is wound on the papillary muscle after the repair patch is implanted.