CN114041903A - A repair device for preventing mitral regurgitation - Google Patents

Abstract

The present invention provides a prosthetic device for preventing mitral regurgitation for use in surgically preventing valve regurgitation in a patient's heart. It is characterized by comprising a bracket and a flow resisting part, wherein the bracket comprises: the first fixing part is annular, a micro-thorn mechanism is arranged on the outer side of the first fixing part, and the flow choking part is arranged on the first fixing part. The second fixing part is spiral and made of shape memory metal wire materials, and is used for being stretched at one end and then shuttled between adjacent chordae tendineae of the heart of a patient in the operation process, and the second fixing part is wound on the adjacent chordae tendineae after external force is removed. And the connecting parts are respectively connected with the first fixing part and the second fixing part. The connecting part is provided with a support rod and a connecting rod. The supporting rod is strip-shaped, and two ends of the supporting rod are respectively connected to the first fixing part. The connecting rod piece is strip-shaped, one end of the connecting rod piece is connected to the middle of the supporting rod piece, and the other end of the connecting rod piece is connected to the other end of the second fixing portion.

Description

Repair device for preventing mitral valve regurgitation

Technical Field

The present invention relates to a prosthetic device for preventing mitral regurgitation.

Background

Mitral regurgitation, left ventricular ejection of blood can occur through two pathways, the aortic and mitral valves. The greater the systemic afterload (i.e. blood pressure) the greater the reflux fraction. Chronic mitral regurgitation, passive expansion of the left atrium without significant pressure increase prevents early shortness of breath (which is very common in mitral stenosis), however, chronic increase in left ventricular preload causes dysfunction of left ventricular dilation and contraction, typically with a later onset of symptoms than mitral stenosis. Acute mitral regurgitation, of course, is immediately symptomatic in that the left atrial pressure rises suddenly without compliance. Mild mitral regurgitation has no obvious clinical symptoms, but when severe regurgitation is treated surgically.

Traditional treatment approaches for mitral and tricuspid valve disease include medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. 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. Many patients do not tolerate the enormous surgical risk and can only remain indefinitely at risk for death.

With the first report of aortic valve intervention replacement, many companies have done a lot of work on interventional aortic valve technology, and the technology is mature. However, there remains a significant gap in the industry in the interventional treatment of atrioventricular valves. Although a few products currently exist for the interventional treatment of atrioventricular valves for transcatheter valvuloplasty and repair, no mature product is yet internationally available for transcatheter valve replacement.

Patents US2009105751a1, CN101902975 describe a device for repairing a valve leaflet in a beating heart of a patient, which comprises a handle assembly, a capture assembly and a needle, wherein the valve leaflet is captured by the capture assembly, and the needle passes through the valve leaflet to limit the movement of the prolapsed valve leaflet so as to achieve the effect of preventing regurgitation, but the technique is operationally required to grasp the moving valve leaflet, is difficult and long in operation, and is easy to tear the autologous valve leaflet.

Patent US20130023985 describes an implant, implant system and method for treating valve insufficiency and other valve diseases, the implant comprising an auxiliary leaflet coaptation, the length of the upper portion of the leaflet coaptation fitting against the native annulus portion being 25-35mm, equal to the distance between the first and second coaptation interfaces, the length of the upper portion of the leaflet coaptation to the lower portion being 50-60mm, and optionally anchoring means provided on the leaflet coaptation, in another claim, in addition to defining the length of the upper portion to conform to the native annulus portion to be 25-35mm, defining the height of the leaflet coaptation portion perpendicular to the annulus to be 35-45mm, defining the height of the ventricular uncoaptation portion perpendicular to the annulus to be 25-35mm, and defining the radius of curvature of the coaptation portion to be within 35-45 mm. The system has length limitation for the upper part fitting the native valve ring part, is only suitable for the whole repair of mitral valve anterior valve or posterior valve prolapse and the whole leaflet prolapse repair of partial tricuspid valve, and shows that the lower length of the conjugant covers at least most leaflets, and the combination part has specific radian requirement. This technique does not accommodate the prolapse of a small valve or the repair of a smaller valve, such as the aortic valve, while sacrificing the remaining properly functioning valves in the repair of an incompetent site. In summary, the disadvantages include: first, it is explicitly stated that the length of the upper part of the coaptation body is equal to the distance between the first and second coaptation junctions, and thus is only suitable for the overall repair of the leaflets, the repair area including both the leaflet prolapse site and the leaflet normal site; second, the valve annulus lengths of individuals vary widely, the distance between the first and second junctional junctions is unpredictable prior to actual surgery, and it is difficult to precisely match product designs; thirdly, the shape of the conjugant part is cone-shaped, which strives to match the cone shape of the human valve leaflet, and the complete matching is difficult because of the difference of human bodies; fourth, the design is not suitable for repair in conjunction with leaflet prolapse.

Patent US20130325110a1 describes a method of treating mitral and tricuspid regurgitation by delivering a leaflet closing prosthesis without beating, the method comprising anchoring a ventricular anchor from the atrium through the native valve to the right ventricle, delivering and adjusting the position of the prosthesis at the tricuspid annulus using a catheter until regurgitation is reduced, securing the catheter relative to the flexible track and to the inferior vena cava. Although the position of the prosthesis can be adjusted by the delivery method to adapt to different reflux positions and have certain pathological adaptability, the position of the prosthesis at the fixed position of the inferior vena cava is far away from the valve ring position, so that the prosthesis is easily unstable to fix and can be displaced after the fixation is finished.

Disclosure of Invention

In order to solve the problems, the invention provides a repair device for preventing mitral regurgitation, which adopts the following technical scheme:

the present invention provides a prosthetic device for preventing mitral regurgitation for use in surgically preventing valve regurgitation in a patient's heart. It is characterized by comprising a bracket and a flow resisting part, wherein the bracket comprises: the first fixing part is annular, a micro-thorn mechanism is arranged on the outer side of the first fixing part, and the flow choking part is arranged on the first fixing part. The second fixing part is spiral and made of shape memory metal wire materials, and is used for being stretched at one end and then shuttled between adjacent chordae tendineae of the heart of a patient in the operation process, and the second fixing part is wound on the adjacent chordae tendineae after external force is removed. And the connecting parts are respectively connected with the first fixing part and the second fixing part. The connecting part is provided with a support rod and a connecting rod. The supporting rod is strip-shaped, and two ends of the supporting rod are respectively connected to the first fixing part. The connecting rod piece is strip-shaped, one end of the connecting rod piece is connected to the middle of the supporting rod piece, and the other end of the connecting rod piece is connected to the other end of the second fixing portion.

The repair device for preventing mitral regurgitation provided by the invention can also have the technical characteristics that the second fixing part is covered by the protective film.

The present invention provides a prosthetic device for preventing mitral regurgitation that may also have the technical feature that the resistive flow component has a width that is two-thirds of the deployed width of a single native leaflet of a patient's heart.

The repair device for preventing mitral valve regurgitation provided by the invention can also have the technical characteristics that the flow resisting part is a single piece, a plurality of pieces, a cylinder, a column or a balloon, or the flow resisting part is a combination of the single piece and the plurality of pieces, or the flow resisting part is a combination of the single piece and the cylinder, or the flow resisting part is a combination of the single piece and the column, or the flow resisting part is a combination of the single piece and the balloon.

The present invention provides a prosthetic device for preventing mitral regurgitation that may also have the technical feature wherein the flow-impeding component is a lattice structure.

The repair device for preventing mitral valve regurgitation provided by the invention can also have the technical characteristics that the flow resisting part is a high polymer material sheet or an animal-derived material sheet, and when the flow resisting part is the high polymer material sheet or the animal-derived material sheet, the holes are formed in the flow resisting part.

Action and Effect of the invention

According to the repair device for preventing mitral valve regurgitation, firstly, the repair device reserves the movement functions of the autologous valve leaflets and the valve leaflets, prevents the prolapsed valve leaflets from overturning through the flow blocking parts, thereby achieving the purpose of preventing the valve regurgitation, and has the advantages of less implants, good hemodynamics and the like.

Secondly, after the chordae tendineae are wound by the second fixing part, on one hand, the fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.

Finally, the invention provides a valve repair device with simpler structure and smaller volume, which can be percutaneously inserted and implanted through apex of heart minimally invasive, and simultaneously, the maximum width of the flow resisting part adopted by the invention is the design of themaximum width 2/3 of the expansion of a single self-valve leaflet, so that the valve repair device has better tissue compliance, reduces the possibility of damaging the valve leaflet, and is particularly suitable for repairing the prolapse of the combined valve leaflet.

Drawings

FIG. 1 is a schematic three-dimensional view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention;

FIG. 2 is an elevation view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention;

FIG. 3 is a schematic illustration of a bracket assembly according to an embodiment of the invention;

FIG. 4 is a schematic view of the connection between the connecting portion and the second fixing portion according to the embodiment of the present invention;

fig. 5 is a schematic structural diagram of a second fixing portion in the embodiment of the invention.

Detailed Description

In order to make the technical means, the original characteristics, the achieved objects and the effects of the present invention easily understood, a prosthetic device for preventing mitral regurgitation of the present invention will be described in detail with reference to the accompanying drawings.

< example >

FIG. 1 is a schematic three-dimensional view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention; fig. 2 is an elevation view of a prosthetic device for preventing mitral regurgitation in an embodiment of the present invention.

As shown in fig. 1 and 2, aprosthetic device 01 for preventing mitral regurgitation includes astent 1 and an obstructingmember 2.

Fig. 3 is a schematic view of a bracket component in an embodiment of the invention.

As shown in fig. 3, thebracket 1 includes afirst fixing portion 11, asecond fixing portion 13, and a connectingportion 12.

Thefirst fixing portion 11 is annular, thefirst fixing portion 11 is disposed in the atrium, and amicro-puncture mechanism 111 is provided on the outside. When theprosthetic device 01 is implanted, themicro-puncture structure 111 is punctured into the autologous valve annulus tissue; themicro-thorn structure 111 helps thefirst fixing part 11 to be anchored at the autologous valve annulus, so as to avoid the deviation of therepair device 01 after being implanted and ensure the repair effect.

The connectingportions 12 connect thefirst fixing portion 11 and thesecond fixing portion 13, respectively.

The connecting portion has asupport link 121 and a connectinglink 122.

The supportingrod 121 is strip-shaped, and two ends of the supporting rod are respectively connected to thefirst fixing portion 11. When theprosthetic device 01 is implanted, thesupport rod member 121 is positioned at the septal valve junction; thesupport rod member 121 is located at the valve partition junction, so that therepair device 01 can be prevented from affecting the operation of the native valve leaflets, and meanwhile, therepair device 01 can be prevented from swinging towards the atrium by theflow blocking part 2.

The connectingrod 122 is in a strip shape, one end of the connecting rod is connected to the middle of the supportingrod 121, and the other end of the connecting rod is connected to the other end of thesecond fixing portion 13.

FIG. 4 is a schematic view of the connection between the connecting portion and the second fixing portion according to the embodiment of the present invention; fig. 5 is a schematic structural diagram of a second fixing portion in the embodiment of the invention.

As shown in fig. 4 and 5, thesecond fixing portion 13 has a spiral shape, and thesecond fixing portion 13 has a preset spiral shape. When preassembling, thesecond fixing portion 13 is straightened to be in a linear state. On one hand, fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.

Thesecond fixing portion 13 is made of shape memory metal wire material. The shape memory metal wire is further provided with aprotective film 131 on the periphery, theprotective film 131 can effectively prevent the tissue from being damaged, meanwhile, theprotective film 131 can prevent the second fixingportion 13 from rubbing with the chordae tendineae, and the second fixingportion 13 can be restored to a preset shape according to a preset path during shuttling. For being shuttled between adjacent chordae tendineae of the patient's heart by one end being straightened and wrapped around the adjacent chordae tendineae upon removal of external force during a procedure.

Thechoke part 2 is provided on the first fixingportion 11.

Theflow resisting part 2 is a single piece, a plurality of pieces, a cylinder, a column or a balloon, or theflow resisting part 2 is a combination of a single piece and a plurality of pieces, or theflow resisting part 2 is a combination of a single piece and a cylinder, or theflow resisting part 2 is a combination of a single piece and a column, or theflow resisting part 2 is a combination of a single piece and a balloon.

Theflow resisting part 2 is of a grid structure, or theflow resisting part 2 is a high polymer material sheet or an animal-derived material sheet, and when theflow resisting part 2 is the high polymer material sheet or the animal-derived material sheet, holes are formed in theflow resisting part 2.

Theflow resisting part 2 is positioned between the patient's autologous valve leaflets in a free state, the maximum width of theflow resisting part 2 is smaller than the maximum width of the single autologous valve leaflet, and preferentially, the maximum width of theflow resisting part 2 is 2/3 of the maximum width of the single autologous valve leaflet.

After theprosthetic device 01 is implanted into the heart, along with the impact of blood flow, theflow blocking part 2 is opened along with the impact, and when the native valve is in the closed state, theflow blocking part 2 is located in the middle area of the native valve, and theflow blocking part 2 can avoid the gap between adjacent valve leaflets, so that the problem of paravalvular leakage is well prevented.

A method of using aprosthetic device 01 for preventing mitral regurgitation in this embodiment is as follows: when preassembling, the second fixingportion 13 is straightened to be in a linear state. When theprosthetic device 01 is implanted, the second fixingpart 13 is shuttled between adjacent chordae tendineae of the heart of the patient by being straightened at one end and wound around the adjacent chordae tendineae after the external force is removed, and themicro-barbed structure 111 of the first fixingpart 11 is inserted into the native annulus tissue and is fixed in position. And thechoke part 2 is opened along with the impact of the blood flow, when the native valve is in a closed state, thechoke part 2 is positioned in the middle area of the native valve, and the mitral valve is prevented from regurgitating.

Examples effects and effects

According to the prosthetic devices for preventing mitral regurgitation provided by the embodiment, firstly, the motion functions of the autologous valve leaflets and the valve leaflets are kept, and the prolapsed valve leaflets are prevented from overturning through the flow blocking parts, so that the aim of preventing the valve regurgitation is fulfilled.

Secondly, after the chordae tendineae are wound by the second fixing part, on one hand, the fixation can be realized, and on the other hand, the gap between the front valve and the rear valve can be further reduced, so that the repair effect is better.

Finally, the embodiment provides a valve repair device with a simpler structure and a smaller volume, the valve repair device can be percutaneously inserted and can be implanted through apical minimally invasive surgery, and meanwhile, the maximum width of the flow blocking part adopted by the invention is themaximum width 2/3 of the expansion of the single self-valve leaflet, so that the valve repair device has better tissue compliance, reduces the possibility of damaging the valve leaflet, and is particularly suitable for repairing the prolapse of the combined valve leaflet.

The above-described embodiments are merely illustrative of specific embodiments of the present invention, and the present invention is not limited to the description of the above-described embodiments.

Claims (6)

Translated fromChinese

1.一种用于阻止二尖瓣反流的修复装置，用于对患者心脏进行外科手术阻止瓣膜反流，其特征在于，包括支架以及阻流部件，1. a repairing device for preventing mitral valve regurgitation, for carrying out a surgical operation to a patient's heart to prevent valve regurgitation, it is characterized in that, comprise stent and blocking part,其中，所述支架包括：Wherein, the bracket includes:第一固定部，呈圆环状，外侧设有微刺机构，所述阻流部件设置在所述第一固定部上；The first fixing part is in the shape of an annular shape, with a micro-thorn mechanism on the outside, and the flow blocking member is arranged on the first fixing part;第二固定部，呈螺旋状，采用形状记忆金属丝材料，用于在手术过程中通过一端被拉直后穿梭于所述患者的心脏的相邻腱索之间并在撤去外力后缠绕在所述相邻腱索上；The second fixing part, in the form of a helix, is made of shape memory wire material, and is used to shuttle between the adjacent chordae tendineae of the patient's heart after one end is straightened during the operation, and is wound around the heart after removing the external force. on the adjacent chordae tendineae;连接部，分别连接所述第一固定部和所述第二固定部，connecting parts, respectively connecting the first fixing part and the second fixing part,所述连接部具有支撑杆件和连接杆件，The connecting part has a supporting rod and a connecting rod,所述支撑杆件为条状，两端分别连接在所述第一固定部上，The support rod is in the shape of a strip, and the two ends are respectively connected to the first fixing part,所述连接杆件为条状，一端连接在所述支撑杆件的中部，另一端连接在所述第二固定部的另一端。The connecting rod is strip-shaped, one end is connected to the middle part of the support rod, and the other end is connected to the other end of the second fixing part.2.根据权利要求1所述的一种用于阻止二尖瓣反流的修复装置，其特征在于：2. A repair device for preventing mitral regurgitation according to claim 1, wherein:其中，所述第二固定部覆有保护膜。Wherein, the second fixing portion is covered with a protective film.3.根据权利要求1所述的一种用于阻止二尖瓣反流的修复装置，其特征在于：3. A repair device for preventing mitral regurgitation according to claim 1, wherein:其中，所述阻流部件宽度为所述患者心脏的单个自体瓣叶展开宽度的三分之二。Wherein, the width of the flow blocking member is two thirds of the unfolded width of a single native valve leaflet of the patient's heart.4.根据权利要求1所述的一种用于阻止二尖瓣反流的修复装置，其特征在于：4. A repair device for preventing mitral regurgitation according to claim 1, wherein:其中，所述阻流部件为单片、多片、筒状、柱状或球囊，或者所述阻流部件为单片与多片的组合，或者所述阻流部件为单片与筒状的组合，或者所述阻流部件为单片与柱状的组合，或者所述阻流部件为单片与球囊的组合。Wherein, the flow blocking member is a single piece, multiple pieces, cylindrical, cylindrical or balloon, or the flow blocking member is a combination of a single piece and multiple pieces, or the flow blocking member is a single piece and a cylindrical shape. Combination, or the flow blocking member is a combination of a single piece and a column, or the flow blocking member is a combination of a single piece and a balloon.5.根据权利要求1所述的一种用于阻止二尖瓣反流的修复装置，其特征在于：5. A repair device for preventing mitral regurgitation according to claim 1, wherein:其中，所述阻流部件为网格结构。Wherein, the blocking member is a grid structure.6.根据权利要求1所述的一种用于阻止二尖瓣反流的修复装置，其特征在于：6. A repair device for preventing mitral regurgitation according to claim 1, wherein:其中，所述阻流部件由高分子材料或动物源性材料制成，并且所述阻流部件上设置有孔。Wherein, the flow blocking member is made of polymer material or animal-derived material, and the flow blocking member is provided with holes.

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