CN115177410A

CN115177410A - Heart valve replacement prosthesis and outer support thereof

Info

Publication number: CN115177410A
Application number: CN202210833682.9A
Authority: CN
Inventors: 贾海涛; 梁涛; 孙嘉康; 陈登高; 李叙璋; 夏兆军; 郭静
Original assignee: Beijing Xinmai Medical Technology Co ltd
Current assignee: Beijing Xinmai Medical Technology Co ltd
Priority date: 2022-07-14
Filing date: 2022-07-14
Publication date: 2022-10-14

Abstract

The invention discloses a heart valve replacement prosthesis and an outer support thereof, and belongs to the field of medical instruments. The outer support comprises an upper top ring, a hemispherical ring support, a contraction transition ring and an inner support fixing section which are arranged from top to bottom, wherein the hemispherical ring support is a hemispherical support frame and is used for supporting the inner wall of an atrium; the upper top ring is an annular ring formed by sequentially connecting all vertexes of the upper part of the hemispherical ring frame by flexible materials and is used for abutting against the top of the atrium; the contraction transition ring is a smooth transition curved surface formed by the inward smooth contraction of the bottom of the hemispherical ring frame and is used for adapting to the shape of the inner wall of the atrium close to the valve ring; the inner support fixing section is a cylindrical structure formed by downwards extending the bottom of the contraction transition ring and is used for being matched with the valve ring shape. The invention forms a unique prosthesis structure matched with the internal physiological structure of the atrium by adopting the three-ring fixed type, D-shaped structure, motion isolation design and design characteristics of lower flexibility and upper rigidity, and achieves the technical effects of safe and reliable fixing mode, convenient operation and simple and convenient processing.

Description

Heart valve replacement prosthesis and outer support thereof

Technical Field

The invention relates to the field of medical instruments, in particular to a heart valve replacement prosthesis and an outer support thereof.

Background

Valvular heart disease refers to the presence of structural or functional abnormalities in the heart valve, which can affect one or more valves. The mitral valve is most affected in the valvular heart disease in China, such as mitral valve stenosis, mitral valve insufficiency or mitral valve stenosis and insufficiency, and then aortic valve. And senile degenerative valvular disease is most commonly characterized by aortic valve disorders, followed by mitral valve, such as aortic stenosis, aortic insufficiency, or aortic stenosis combined with insufficiency.

Heart valve replacement is a type of surgery for patients with heart valve disease, and the main methods at present are surgical valve replacement and interventional repair or valve replacement. Surgical valve replacement requires opening the chest, cutting the heart under general anesthesia, cutting the diseased valve, and suturing the normal synthetic or metallic valve to the original valve position. The interventional operation belongs to a minimally invasive operation, does not need to open a chest, is operated under the condition of surgical transvascular operation or is operated by cooperation of internal and external surgeons, and has small wound.

With the development of heart intervention valve surgery, various products for treating mitral valve diseases are also disclosed. Various mitral valve replacement prostheses currently designed on the market are broadly classified into: barb-retaining classes such as Intrepid of force of Meidun; barb-anchoring species, such as Edward's CardAQ; the hoop fixation class, such as Sapien M3 by Edward and Highliffe by Peijabi; apical tether fixation, such as tendyne by yapei; atrial fixation, such as 4C Medical available for minimally invasive cardiotomy. However, all the products have the problems that barbs or barbs easily cause myocardial electrical signal disorder, mismatch of valve ring shapes, heart fracture and the like; the operation difficulty of the hoop fixing operation is too high, and the popularization and the implementation are not easy; the apical tether easily shields the outflow tract, and secondary operation is required for tether adjustment; the atrial fixation has few indications, so that narrow patients cannot be treated, and the form matching of the left atrium is too complex, so that displacement is easy to occur.

It is therefore evident that the above-mentioned conventional heart valve replacement prosthesis, in terms of structure, method and use, still has the disadvantages and drawbacks, and further improvements are desired. How to create a new heart valve replacement prosthesis and an external bracket thereof, so that the technical effects of safe and reliable fixing mode, convenient operation and simple and convenient processing are achieved, reliable guarantee is provided for heart intervention valve operation, and the aim of great improvement in the current industry is achieved.

Disclosure of Invention

The invention aims to solve the technical problem of providing an external support of a heart valve replacement prosthesis, which forms a unique external support structure matched with the internal physiological structure of an atrium by adopting the characteristics of three-ring fixing design, D-shaped anatomical design, motion isolation design and flexible-down and rigid-up design, achieves the technical effects of safe and reliable fixing mode, convenient operation and simple and convenient processing, and provides reliable guarantee for heart intervention valve operation.

In order to solve the technical problems, the invention provides an outer support of a heart valve replacement prosthesis, which comprises an upper top ring, a hemispherical ring support, a contraction transition ring and an inner support fixing section, wherein the upper top ring, the hemispherical ring support, the contraction transition ring and the inner support fixing section are arranged from top to bottom; the upper top ring is an annular ring formed by sequentially connecting all vertexes of the hemispherical supporting frame by flexible materials and is used for abutting against the top of the atrium; the contraction transition ring is a smooth transition curved surface formed by inward smooth contraction of the bottom of the hemispherical support frame and is used for adapting to the shape of the inner wall of the atrium close to the valve annulus; the inner support fixing section is a cylindrical structure formed by downwards extending the bottom of the contraction transition ring and is used for being matched with the valve ring shape, and a fixing mechanism connected with the inner support is arranged at the bottom of the inner support fixing section.

In a further improvement, the hemispherical support frame forms support for the front inner wall and the rear inner wall of the atrium in at least two directions.

In a further improvement, the flexible material of the upper top ring is a high polymer material.

In a further improvement, the cross section of the inner support fixing section adopts a D-shaped structure matched with the anatomical shape of the valve annulus.

In a further improvement, the smooth transition curved surface of the contraction transition ring comprises a main valve supporting curved surface close to the aorta side and an auricle supporting curved surface arranged opposite to the main valve supporting curved surface, and the included angles of the main valve supporting curved surface and the auricle supporting curved surface are different.

The improved structure is further improved in that the included angle of the curved surface of the main valve supporting curved surface is 40-80 degrees, and the included angle of the curved surface of the auricle supporting curved surface is 5-30 degrees.

In a further improvement, the sum of the heights of the hemispherical ring frame and the contraction transition ring is 40-80mm, and the height of the inner frame fixing section is 5-25mm.

In a further improvement, the hemispherical ring frame, the contracting transition ring and the inner support fixing section are integrally formed by nickel titanium alloy or nitinol alloy, the base thicknesses of the support rods of the hemispherical ring frame, the contracting transition ring and the inner support fixing section are all 0.3-0.7mm, the widths of the support rods of the hemispherical ring frame and the contracting transition ring are 0.5-1.5mm, and the width of the support rod of the inner support fixing section is 0.3-0.7mm.

In a further improvement, the fixing mechanism is an expansion foot piece which penetrates through the inner support row holes from the bottom of the inner support fixing section.

As a further improvement, the invention also provides a heart valve replacement prosthesis, which comprises an outer support of the heart valve replacement prosthesis and an inner support for fixing a biological membrane, wherein the inner support is arranged inside the outer support, and the bottom of the fixing section of the inner support of the outer support is fixedly connected with the bottom row holes of the inner support.

After adopting such design, the invention has at least the following advantages:

the outer support of the heart valve replacement prosthesis forms a three-ring fixed structure by using the upper support ring, the middle support ring and the lower support ring, so that the outer support is stably and reliably fixed in an atrium, and the prosthesis is prevented from moving in the vertical direction. Meanwhile, the inner support fixing section of the outer support extends into the position of the mitral valve annulus, so that the outer support cannot move in the left-right direction. The prosthesis has strong anti-rotation capability through the asymmetrical arrangement of the D-shaped inner support fixing section of the outer support and the asymmetrical contraction transition ring, and the whole fixing problem of the prosthesis is perfectly solved by the structure of the outer support.

The width of the upper and lower support rods of the outer support is different, so that the flexible and rigid-down arrangement characteristic is formed, the device is suitable for the periodic form change of the mitral valve, and has enough supporting force, the problem of long-term, stable and effective fixation of a biological membrane to the mitral valve ring position is solved, perfect fixation in an atrium is realized, and the contraction and relaxation movement of the atrium is not influenced.

The heart valve replacement prosthesis is safe and reliable in fixing mode, does not damage any tissue structure, and solves the problems that barbs and barbs can cause electrical signal disorder, the hoops can cause chordae tendineae to break, the tethers can cause outflow tract shielding, and meanwhile apex cordis pads can possibly have apex cordis bleeding risks. The heart valve replacement prosthesis can be used for performing the operation in a manner of transfemoral vein and atrial septal puncture, can also be used for performing the operation in a manner of transapical puncture, and is simple and easy to operate. Meanwhile, the operation storage and transportation are easy. The heart valve replacement prosthesis is easy to process and form, and can realize large-scale stable production.

Drawings

The foregoing is only an overview of the technical solutions of the present invention, and in order to make the technical solutions of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and the detailed description.

Fig. 1 is a schematic front view of the construction of a heart valve replacement prosthesis of the present invention.

Fig. 2 is a schematic structural front view of an outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 3 is a schematic structural side view of an outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 4 is a schematic top view of the outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 5 is a perspective view of an outer stent of the heart valve replacement prosthesis of the present invention.

Detailed Description

Through research on the fixing mode of the existing product, the invention finds that the core problems of the valve replacement prosthesis are as follows: how to fix the biological membrane on the valve ring position firmly, stably and unaffected, and the systolic and diastolic movement of the heart is not affected. On the basis, the invention creatively provides a three-ring fixed mitral valve replacement prosthesis structure. Specific examples thereof are as follows.

In this embodiment, a mitral valve replacement prosthesis is taken as an example to describe the technical solution of the present invention in detail, which should not be construed as any limitation to the present application, and the present application may also be applied to a tricuspid valve replacement prosthesis, an active valve prosthesis, and the like.

Referring to fig. 1, the mitral valve replacement prosthesis of the present embodiment includes an outer stent 1 and an inner stent 2. The inner support 2 is arranged inside the outer support 1, and the bottom of the outer support 1 is fixedly connected with the bottom of the inner support 2.

Referring to fig. 2 to 5, in this embodiment, the external frame 1 includes an upper top ring 11, a hemispherical ring frame 12, a contracting transition ring 13 and an internal frame fixing section 14 arranged from top to bottom. In this embodiment, the hemispherical ring frame 12 is a hemispherical support frame for supporting the inner wall of the left atrium. The semi-sphere shape is similar to a semi-sphere shape, can be an ellipsoid shape, can be a semi-sphere shape, and the like. The hemispherical ring frame 12 is mainly matched with the inner shape of the left atrium, and supports the inner wall of the left atrium in 6 directions, such as up and down, left and right, front and back, so as to ensure that the position of the mitral valve replacement prosthesis does not shift and rotate in the heart movement process.

For the sake of simplicity and convenience of manufacture, the hemispherical ring 12 provides support for the anterior and posterior walls of the atrium in at least two directions, to balance the manufacturing and support effects. Thus, the support of the inner wall of the left atrium by the hemispherical ring frame 12 forms the middle support ring in the external frame three-ring fixation.

The upper top ring 11 is an annular ring formed by sequentially connecting all vertexes of the hemispherical support frame by flexible materials and is used for abutting against the top of the left atrium. The flexible material of the upper top ring 11 is a high molecular polymer material, preferably polyethylene, ultrahigh molecular weight polyethylene, polytetrafluoroethylene, polyester fiber, or the like. The upper top ring 11 can be made of a single strand rope or a braided rope, and the thickness of the rope is 0.5-2 mm. The upper top ring 11 may be circular, elliptical, or any other closed-loop curve in space. The upper top ring 11 must be in contact with the top of the left atrium during use, forming a vertical support point, i.e. the upper support ring in the three-ring fixation of the external stent.

The contraction transition ring 13 is a smooth transition curved surface formed by the inward smooth contraction of the bottom of the hemispherical support frame and is used for adapting to the shape of the inner wall of the atrium close to the valve annulus. The smooth transition curved surface of the contraction transition ring 13 includes a main valve support curved surface 131 adjacent to the aortic side and an atrial appendage support curved surface 132 disposed opposite to the main valve support curved surface 131. The main valve supporting curved surface 131 is located on one side close to the aorta during surgical installation, can be matched with the shape of the left atrium on one side close to the aortic valve, and can not extrude the aortic valve during systolic and diastolic movement of the heart. The auricle support curve 132 is positioned on the side near the left auricle during surgical installation to match the left atrial morphology.

Specifically, to better accommodate the lower anatomy of the left atrium near the annulus, the main valve support curve 131 and the atrial appendage support curve 132 have different curve angles. If the curved angle of the main valve supporting curved surface 131 is 40-80 degrees, and the curved angle of the auricle supporting curved surface 132 is 5-30 degrees. That is, the curvature of the main valve support curved surface 131 is greater than that of the auricle support curved surface 132, thereby further improving the fitting between the external stent and the lower part of the left atrium.

Thus, the main valve support curved surface 131 and the auricle support curved surface 132 and the generally connecting petal curved surfaces therebetween can form a smooth transition surface of the contracting transition ring 13. The complex curved topography of the smooth transition surface provides a good fit on the left atrium near the mitral annulus and is also an important fixation feature to prevent downward migration of the replacement prosthesis itself, i.e., the lower support ring in the external stented tri-ring fixation.

The inner support fixing section 14 is a cylindrical structure formed by extending the bottom of the contraction transition ring 13 downwards and is used for adapting to the shape of the mitral valve annulus. The cross-section of the inner stent anchoring section 14 in this embodiment is a D-shaped structure matching the anatomy of the mitral annulus, as shown in figure 4. The D-shaped structure can fully adapt to the shapes of the mitral valve rings of all patients, and the paravalvular leakage caused by the mismatching of the shapes is prevented. And D-shaped structures with various specifications can be set according to different ages, sexes, ethnicities, disease types and the like of patients.

In order to adapt to the mitral valve annulus, which belongs to a saddle-shaped structure, the cylindrical structure of the inner support fixing section 14 needs to have a certain height, and in this embodiment, the height h of the inner support fixing section 14 should be controlled to be 5-25mm, so as to realize the occlusion of the mitral valve and ensure that the problem of paravalvular leakage does not occur.

The inner stent 2 in this embodiment is used to attach a biological membrane, which may be bovine pericardium, porcine pericardium, or porcine aortic valve. The inner stent 2 may be any other frame structure of the inner stent of the existing valve replacement prosthesis.

The bottom of the inner bracket fixing section 14 in this embodiment is provided with a fixing mechanism 141 connected with the inner bracket 2. The fixing mechanism 141 is an expansion foot piece which penetrates through the row holes 21 of the lower connecting columns of the inner support 2 from the bottom of the inner support fixing section 14, and is stable, reliable and simple and convenient to operate.

The hemispherical ring frames 12, the collapsed transition rings 13, and the inner frame securing segments 14 in the present embodiment are integrally formed from a memory alloy such as nitinol or nitinol. The method is specifically characterized in that the nickel-titanium alloy pipe or the nickel-titanium alloy pipe is made by a laser cutting mode and then a heat treatment shaping mode. Wherein, according to the physiological anatomical data of the patient, the height of the hemispherical ring frame 12 and the contraction transition ring 13 should be 40-80mm, and the height of the inner frame fixing section is 5-25mm.

The basic thickness of the support rods of the hemispherical ring support 12, the shrinkage transition ring 13 and the inner support fixing section 14 is the wall thickness of the cutting pipe, and is specifically 0.3-0.7mm. The widths of the support rods of the hemispherical ring frame 12 and the contraction transition ring 13 are 0.5-1.5mm, and the width of the support rod of the inner support fixing section 14 is 0.3-0.7mm. Therefore, as the width of the stent rod of the inner stent fixing section 14 is narrower, a part softer than the hemispherical ring frame 12 and the contraction transition ring 13 is formed, namely the technical effect of softness and rigidity at the lower part of the application is achieved, and the left atrium contraction and relaxation movement can be better adapted.

The heart valve replacement prosthesis fixes the prosthesis in the left atrium by using the upper support ring, the middle support ring and the lower support ring, so that the prosthesis cannot move in the up-down direction. The top ring is arranged at the top end of the prosthesis, so that the top ring is guaranteed to touch the top of the left atrium, the middle part of the prosthesis adopts a spherical-like ring frame to fully support the front, back, left and right parts of the left atrium, and the front, back, symmetrical and left and right asymmetrical petal transition forms are arranged below the left atrium, so that the prosthesis is well attached to the left atrium close to the mitral valve annulus. Meanwhile, the outer bracket extends downwards to the mitral valve annulus, so that the prosthesis cannot move in the left-right direction. More importantly, the asymmetric arrangement of the D-shaped inner support fixing section of the outer support and the asymmetric contraction transition ring is combined with the connection of the inner support and the outer support, so that the prosthesis has strong anti-rotation capability, the rotation of the prosthesis is directly inhibited from the structure, and the problem of integral fixation of the prosthesis is perfectly solved.

The heart valve replacement prosthesis also forms a very important motion isolation effect through the matching of the outer support and the inner support. The arrangement characteristics of the outer bracket, namely the lower part and the upper part are flexible and rigid, so that the biological membrane is stably and effectively fixed on the mitral valve annulus for a long time. Those skilled in the art will appreciate that the stent structure of the replacement prosthesis within the left atrium must be sufficiently supportive, and that being too stiff may affect the systolic relaxation of the left atrium, while being too soft may result in displacement of the prosthesis and even periodic up and down oscillations of the prosthesis, thereby resulting in severe paravalvular leakage. Therefore, the D-shaped fixing section of the outer stent is of a soft structure due to the narrow width of the stent rod, and can adapt to the periodic morphological change of the mitral valve. And the upper hemispherical ring frame and the contraction transition ring are rigid structures due to the wide width of the support rod, so that enough support can be ensured, and the left atrium cannot be damaged. Therefore, the heart valve replacement prosthesis can realize perfect fixation in the atrium, and does not influence the contraction and relaxation movement of the atrium.

In the description of the present invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the present invention in any way, and it will be apparent to those skilled in the art that the above description of the present invention can be applied to various modifications, equivalent variations or modifications without departing from the spirit and scope of the present invention.

Claims

1. The outer support of the heart valve replacement prosthesis is characterized by comprising an upper top ring, a hemispherical ring support, a contraction transition ring and an inner support fixing section which are arranged from top to bottom, wherein the hemispherical ring support is a hemispherical support frame and is used for supporting the inner wall of an atrium; the upper top ring is an annular ring formed by sequentially connecting all vertexes of the hemispherical supporting frame by flexible materials and is used for abutting against the top of the atrium; the contraction transition ring is a smooth transition curved surface formed by inward smooth contraction of the bottom of the hemispherical support frame and is used for adapting to the shape of the inner wall of the atrium close to the valve annulus; the inner support fixing section is a cylindrical structure formed by downwards extending the bottom of the contraction transition ring and is used for being matched with the valve ring shape, and a fixing mechanism connected with the inner support is arranged at the bottom of the inner support fixing section.

2. The external stent of a heart valve replacement prosthesis according to claim 1, wherein said hemispherical support frame forms support for the anterior and posterior inner walls of the atrium in at least two anterior and posterior directions.

3. The outer stent of the heart valve replacement prosthesis of claim 1, wherein the flexible material of the upper top ring is a polymeric polymer material.

4. The outer stent of a heart valve replacement prosthesis of claim 1, wherein the cross-section of the inner stent fixation section adopts a D-shaped configuration matching the anatomical morphology of the annulus.

5. The external stent of a heart valve replacement prosthesis according to claim 1, wherein the smooth transition curved surface of the contraction transition ring includes a main valve supporting curved surface adjacent to the aortic side and an auricle supporting curved surface disposed opposite to the main valve supporting curved surface, and the main valve supporting curved surface and the auricle supporting curved surface have different curved surface included angles.

6. The outer stent of a heart valve replacement prosthesis according to claim 5, wherein the curved surface angle of the main valve support curved surface is 40-80 degrees, and the curved surface angle of the auricle support curved surface is 5-30 degrees.

7. The outer stent of the heart valve replacement prosthesis of claim 1, wherein the sum of the heights of the hemispherical ring stent and the contracting transition ring is 40-80mm, and the height of the inner stent fixing section is 5-25mm.

8. The external stent of a heart valve replacement prosthesis according to claim 7, wherein the hemispherical ring stent, the contracting transition ring and the internal stent fixing section are integrally formed of nitinol or nitinol, the base thickness of the stent struts of the hemispherical ring stent, the contracting transition ring and the internal stent fixing section are each 0.3-0.7mm, the width of the stent struts of the hemispherical ring stent and the contracting transition ring is 0.5-1.5mm, and the width of the stent struts of the internal stent fixing section is 0.3-0.7mm.

9. The outer stent of a heart valve replacement prosthesis of claim 1, wherein the securing mechanism is an expansion leg extending from a bottom of the inner stent fixation segment through an inner stent slot.

10. A heart valve replacement prosthesis, comprising an outer stent of the heart valve replacement prosthesis according to any one of claims 1 to 9, and an inner stent for fixing a biofilm, wherein the inner stent is arranged inside the outer stent, and the bottom of an inner stent fixing section of the outer stent is fixedly connected with a bottom row hole of the inner stent.