CN115153964A - Heart valve replacement prosthesis - Google Patents

Abstract

The invention discloses a heart valve replacement prosthesis, and belongs to the field of medical instruments. The heart valve replacement prosthesis comprises an outer support and an inner support arranged inside the outer support, wherein a polyester fiber coat is coated outside the outer surgical support, and the inner surgical support is used for fixing a biological membrane. Wherein the outer stent supports the inner wall of the atrium and adapts the inner wall shape of the atrium close to the valve ring, and the D-shaped structure is used for adapting the valve ring shape. The inner support adopts a cylindrical outer frame structure surrounded by three arch-shaped sewing frames, the lower parts of the inner support are connected through a traction ring, and a retainer is arranged inside the three arch-shaped sewing frames. The invention forms a unique prosthesis structure matched with the internal physiological structure of the atrium by adopting the characteristics of an internal and external double-layer bracket, a three-ring fixed type, a D-shaped structure, a motion isolation design and a design of flexibility and rigidity at the lower part, thereby achieving the technical effects of safe and reliable fixing mode, convenient operation and simple and convenient processing.

Description

Heart valve replacement prosthesis

Technical Field

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

Background

Valvular heart disease refers to the presence of structural or functional abnormalities in the heart valve, which can affect one or more valves. In valvular heart disease in China, the mitral valve is most affected, such as mitral stenosis, mitral insufficiency or mitral 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 valves, 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 metal 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-fixed class, such as Sapien M3 in Edward and Highlfide in Pejoy; apical tether fixation, such as tendyne, yapei; atrial fixation, such as 4C Medical for minimally invasive cardiotomy. However, all the products have the problems that the barbs or barbs easily cause myocardial electrical signal disorder, the shapes of valve rings are not matched and the like; the operation of the hoop fixation operation is difficult to be overlarge and difficult to be popularized and implemented; 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, which achieves the effect of motion isolation design through an inner-layer support and an outer support with the characteristics of three-ring fixation, D-shaped anatomy type, soft-down and rigid-up design and an inner support with large-span deformation to form a unique prosthesis structure matched with the internal physiological structure of an atrium, achieves the technical effects of safe and reliable fixation mode, convenient operation and simple and convenient processing, provides reliable guarantee for heart intervention valve operation, and becomes the object which is greatly required to be improved in the current industry.

Disclosure of Invention

The invention aims to provide a heart valve replacement prosthesis, which achieves the effect of motion isolation design through an inner-layer stent and an outer-layer stent, forms a unique prosthesis structure matched with the internal physiological structure of an atrium through an outer stent and an inner stent with the characteristics of three-ring fixation, D-shaped anatomy type, soft-down and rigid-up design, and large-span deformation, achieves the technical effects of safe and reliable fixation 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 a heart valve replacement prosthesis which comprises an outer support and an inner support arranged inside the outer support, wherein a polyester fiber coat is coated outside the outer support, and the inner support is used for fixing a biological membrane.

The improved structure is characterized in that 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, and 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.

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.

In a further improvement, the flexible material of the upper top ring is made of high polymer material, the hemispherical support frame forms support for the front and rear inner walls of the atrium in at least the front and rear directions, the cross section of the inner support fixing section is of a D-shaped structure matched with the anatomical form of the valve ring, and the fixing mechanism is an expansion leg piece which penetrates through the row holes of the inner support from the bottom of the inner support fixing section.

In a further improvement, the polyester fiber coat is wrapped on the outer sides of the contraction transition ring and the inner support fixing section and used for preventing blood in ventricles from overflowing to atria.

The heart valve replacement prosthesis is characterized in that the inner support is of a cylindrical outer frame structure formed by three arch-shaped sewing frames in a surrounding mode, every two adjacent arch-shaped column parts of the three arch-shaped sewing frames are combined to form a fixed column, the lower parts of the three fixed columns are connected through a traction ring, retainers are arranged inside arches of the three arch-shaped sewing frames, the lower parts of the retainers are fixed rods connected with the traction ring, the upper parts of the retainers are heart-shaped support frames with broken upper edges extending out from the upper ends of the fixed rods, the ends with the broken upper edges are connected with the upper parts of the arch-shaped sewing frames after being turned back outwards, the fixed columns and the fixed rods are provided with row holes, the traction ring is provided with protruding hooks deviating from the arch-shaped sewing frames, and the protruding hooks are used for being matched and connected with connecting ends on external conveying equipment to achieve loading and recovery of the heart valve replacement prosthesis.

The cylindrical outer frame structure is further improved, a plurality of protruding hooks are arranged on the traction ring, the protruding hooks are uniformly arranged on the traction ring between the fixing column and the fixing rod, and protruding structures of the protruding hooks are tightened towards the central axis direction of the cylindrical outer frame structure;

the top parts of the three arch-shaped sewing frames are provided with hanging rings, and the hanging rings are arranged on the outer side or the inner side of the top parts of the arch-shaped sewing frames.

In a further improvement, the hemispherical ring support, the contracting transition ring and the inner support fixing section of the outer support are integrally processed and formed by adopting nitinol or nitinol alloy, the widths of the support rods of the hemispherical ring support 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;

the inner stent is integrally formed from nitinol or nitinol alloy.

In a further improvement, the heart valve replacement prosthesis further comprises a polyester fiber connecting film, wherein the polyester fiber connecting film is connected with the top of the contraction transition ring and the top of the arch-shaped suture frame of the inner frame and is used for preventing blood in the ventricle from overflowing from a gap between the inner frame fixing section and the inner frame to the atrium.

In a further improvement, the biological membrane is a porcine pericardium, a porcine aortic valve, a bovine pericardium or an artificial synthetic polymer membrane, and the number of the biological membranes is 2, 3 or 6.

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

1. the outer support in 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.

2. The inner support of the heart valve replacement prosthesis is in a cylindrical outer frame structure surrounded by the arched sewing frame, and the lower part of the fixing column of the inner support is provided with the circular traction ring, so that the rigidity of the cylindrical outer frame structure is improved, the inner support is conveniently matched and connected with the connecting end on external conveying equipment through the convex hook on the inner support, the heart valve replacement prosthesis is loaded and recovered, and the requirement of interventional operation is met. The heart-shaped retainer is arranged in the arch-shaped sewing frame, the restriction of a diamond unit cell structure of the existing support is completely broken through, the design freedom degree of a cutting design drawing is larger, the large-span deformation of the inner support during heat treatment setting can be realized, and the inner support has an internal damping effect due to the S-shaped structure formed by the foldback of the upper part of the heart-shaped retainer so as to consume various loads transmitted from the outside, particularly fatigue loads, thereby prolonging the service life of the prosthesis and achieving high production yield of the inner support.

Still set up to inwards tighten up the structure with protruding couple, can guarantee at the in-process of valve prosthesis release that outside conveying system and valve prosthesis separate gradually, rather than breaking off suddenly, avoid producing an impact force in the twinkling of an eye after separating suddenly, lead to producing in the operation consequence such as electrocardio signal disorder, valve surrounding tissue damage, promote the operation success rate.

3. The heart valve replacement prosthesis is used for plugging the left ventricular blood and preventing the blood from flowing back to the left atrium by sewing the polyester fiber coat on the lower part of the outer support. The top of the contraction transition ring and the top of the arched sewing frame of the inner frame are connected with the polyester fiber connecting film, so that blood in the left ventricle can be better prevented from overflowing to the left atrium from a gap between the fixed section of the inner frame and the inner frame, and the auxiliary prosthesis can better prevent the perivalvular leakage to the maximum extent.

4. The heart valve replacement prosthesis has the advantages that the outer support and the inner support are matched to form a motion isolation effect, the outer support is soft and can perform random matching motion along with the contraction and the relaxation of the heart, the inner support is hard and supports the biological membrane to open and close naturally, the deformation load of the outer support is not easily transmitted to the inner support, the biological membrane is opened and closed normally for a long time, the influence of the change of the heart during the diastole and the contraction is avoided, and the treatment effect and the service life of the valve replacement prosthesis are greatly prolonged.

5. The heart valve replacement prosthesis has the advantages of being safe and reliable in fixing mode, not damaging any tissue structure, and overcoming the problems that barbs and barbs can cause electrical signal disorder, the hoops can cause tendon rupture, tethers can cause outflow tract shielding, and apex cordis pads can have apex cordis bleeding risks. The heart valve replacement prosthesis can be used for performing an operation in a manner of transfemoral vein and atrial septal puncture, can also be used for performing an 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 means 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 side view of the structure of the heart valve replacement prosthesis of the present invention.

Fig. 3 is a schematic, rear view of the structure of the heart valve replacement prosthesis of the present invention.

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

Fig. 5 is a schematic perspective view of a heart valve replacement prosthesis of the present invention.

Fig. 6 is a schematic structural front view of an outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 7 is a schematic structural side view of an outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 8 is a schematic top view of the outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 9 is a perspective view of an outer stent of the heart valve replacement prosthesis of the present invention.

Fig. 10 is a schematic front view of the construction of an inner stent of the heart valve replacement prosthesis of the present invention.

Fig. 11 is a schematic side view of the inner stent structure of the heart valve replacement prosthesis of the present invention.

Fig. 12 is a perspective view of an inner stent of the heart valve replacement prosthesis of the present invention.

Fig. 13 is a schematic top view of the construction of an inner stent of the heart valve replacement prosthesis of the present invention.

Fig. 14 is a schematic view of a deployed configuration of an inner stent of the heart valve replacement prosthesis of the present invention.

Fig. 15 is a schematic view of the post-laser-cut tubing construction of an inner stent of the heart valve replacement prosthesis of the present invention.

Figure 16 is a schematic representation of a laser cut tube deployment configuration of an inner 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.

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

Referring to fig. 1 to 5, 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. 6 to 9, in the present 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. The hemispherical ring frame 12 in this embodiment is a hemispherical support frame for supporting the inner wall of the left atrium. The hemisphere is similar to a hemisphere, can be an ellipsoid, can also be a hemispherical shape, and the like. The hemispherical ring frame 12 is mainly matched with the internal form of the left atrium, and supports the inner wall of the left atrium in 6 directions, such as up-down, left-right, front-back and the like, so as to ensure that the position of the mitral valve replacement prosthesis does not shift and rotate in the heart movement process. Wherein, a certain gap can be left in the left and right directions to ensure that 4 pulmonary vein passages are smooth.

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, and 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 0.5-2mm. The upper top ring 11 may be circular, elliptical, or any other closed-loop curve. 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 frame.

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 transitional curved surface of the contraction transition ring 13 includes a main valve supporting curved surface 131 adjacent to the aortic side and an atrial appendage supporting curved surface 132 disposed opposite to the main valve supporting 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 segment 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.

In order to better prevent the perivalvular leakage problem, the outside of the contraction transition ring 13 and the inner support fixing section 14 are both wrapped with a polyester fiber coat, namely, the contraction transition ring and the inner support fixing section 14 are started from the bottom of the inner support fixing section 14 and ended from the lower edge of the hemispherical ring frame 12, and are used for blocking the left ventricle blood and preventing the blood from flowing back to the left atrium. It should be noted that the length of the polyester fabric cover should not be too long so as not to block the pulmonary vein access on both sides of the hemispherical ring frame 12.

The inner stent 2 in this embodiment is used for connecting a biological membrane, which may be a bovine pericardium, a porcine pericardium or a porcine aortic valve, or may be an artificial polymer membrane. The biofilm may be 2, 3 or 6 sheets, preferably 3 sheets.

Referring to fig. 10 to 14, in the present embodiment, the inner support 2 adopts a cylindrical outer frame structure surrounded by three arch-shaped sewing frames 21, two adjacent arch-shaped column portions of the three arch-shaped sewing frames 21 are combined into a fixed column 22, and the fixed column 22 is provided with a row of holes 221. And the lower parts of the three fixing columns 22 are connected through a traction ring 23, and the traction ring 23 can keep the cylindrical shape of the inner support 2 and well keep enough rigidity of the cylindrical outer frame structure. The traction ring 23 is provided with a convex hook 231 deviating from the arched sewing frame 21, and the convex hook 231 is used for being matched and connected with a connecting end on external conveying equipment, so that loading and recovery of the heart valve replacement prosthesis and the inner support thereof are realized.

The retaining frames 24 are arranged in the arch-shaped inner parts of the three arch-shaped sewing frames 21, the lower parts of the retaining frames 24 are fixed rods 241 connected with the traction ring 23, and the fixed rods 241 are provided with row holes 2411. The upper part of the retainer 24 is a heart-shaped support frame 242 with a broken upper edge extending from the upper end of the fixing rod 241, and two ends of the broken upper edge are respectively folded back outwards and then connected with the upper part of the arch-shaped sewing frame 21, so that the connection between the heart-shaped support frame 242 and the arch-shaped sewing frame 21 has two symmetrical S shapes instead of a straightened state, and the S shapes can ensure that the whole retainer 24 has certain elasticity, even if the whole inner support frame keeps enough rigidity, the inner support frame also has certain internal elasticity, a certain damping effect is formed, various loads conducted from the outside are consumed, particularly fatigue loads, and the service life of the inner support frame is prolonged.

The retainer 24 and the arch-shaped sewing frame 21 can provide enough rigid support for the whole inner support, the fixing rod 241 and the fixing column 22 provide fixing positions for the connection of the outer support 1 and the inner support 2, and the connection of the fixing rod 241 and the traction rod 23 provides further support for maintaining the cylindrical shape characteristic of the inner support 2. The design of the heart-shaped support frame 242 is more suitable for the form change of a large span than the existing rhombic unit cell structure, and meanwhile, enough connection strength is kept, so that powerful guarantee is provided for improving the production yield of the inner support frame.

The widths of the fixed column 22 and the fixed rod 241 are both wider and 2-4 times, preferably 3 times, of the widths of other parts, for example, the line width of the arch-shaped sewing frame 21 is 0.5mm, and the preferred width of the fixed column 22 is 1.5mm. The fixation posts 22 and fixation bars 241 provide effective support for maintaining sufficient rigidity of the overall stent structure to maintain the proper opening and closing of the biofilm after implantation in the patient, without being affected by systolic and diastolic motion.

The fixing columns 22 and the fixing rods 241 are uniformly arranged at intervals, wherein the fixing columns 22 are used for connecting the inner support 2 and the outer support 1 and are also used for fixing a biological membrane; the fixing bar 241 is used only for the connection of the inner stent 2 and the outer stent 1. Therefore, the number of the row holes 221 on the fixing post 22 is greater than or equal to the number of the row holes 2411 on the fixing post 241. If the number of the row holes 221 on the fixing column 22 is 4-10, and the number of the row holes 2411 on the fixing rod 241 is 1-7. Preferably, the number of the row holes 221 on the fixing column 22 is 5, and the number of the row holes 2411 on the fixing rod 241 is 4. In particular, the number of said rows should not be too high, otherwise the overall rigidity of the support is affected. And the more the row holes, the longer the fixing column 22 and the fixing rod 241 are, the greater the rigidity of the inner bracket is, and the more difficult the production process is to shape. The function of the row of holes comprises: firstly, when the fixing column 22 fixes the biological membrane, the row of holes can be used as pinholes, so as to provide sufficient fixing positions, thereby ensuring that the biological membrane is firmly fixed and cannot move up and down along the fixing column 22; secondly, a fixed position is provided for the connection of the inner support and the outer support, the support legs of the outer support 1 can penetrate through the row holes and then are fixed with the inner support 2 through deformation and interference, the inner support 2 and the outer support 1 can be sewn together through the row holes, and of course, the inner support and the outer support can be welded together.

In this embodiment, the pulling ring 23 is provided with a plurality of protruding hooks 231, and the plurality of protruding hooks 231 are uniformly arranged on the pulling ring 23 between the fixing post 22 and the fixing rod 241. The number of the protruding hooks 231 may be the same as or 2 times the sum of the number of the fixing posts and the fixing bars. The shape of the protruding hook 231 is a half-ring shape, which may be a half of a semicircle, a half of an ellipse, a triangle, or other polygonal shapes. The function of the protruding hook 231 is: important connection points are provided when the stent 2 or the whole valve prosthesis is stored (interventional procedures, which take the product inside a thin tube). The connecting end of the external delivery system can be provided with a structure matched and connected with the convex hook 231, and the structure can be embedded into the hook 231 and hang the hook 231, so that the inner support 2 or the valve prosthesis can be pulled in the thin tube to be stored.

In this embodiment, the protruding structures of the protruding hooks 231 are all tightened towards the central axis direction of the cylindrical outer frame structure. The inward convergent angle of the raised hook 231 is 0-30 °. The inward-tightening form design aims to ensure that the external delivery system and the valve prosthesis are gradually separated rather than suddenly separated in the release process of the valve prosthesis, so as to avoid the sudden separation of the valve prosthesis and the delivery system, which can generate an impact force instantly and possibly generate the consequences of electrocardiosignal disorder, damage of tissues around the valve and the like in an operation. The inward tightening structure can improve the success rate of the operation to the maximum extent and obtain unexpected technical effects.

The top parts of the three arch-shaped sewing frames 21 are provided with hanging rings 211, and the hanging rings 211 are arranged on the outer side or the inner side of the middle of the top parts of the arch-shaped sewing frames 21. The main function of rings 211 is when sewing the biomembrane or connect the membrane, is used for fixing the position of this biomembrane or connect the membrane, avoids when not having rings biomembrane or connect the membrane and can produce the slippage along the frame of arch sewing frame 21, leads to the structure unstable. The aperture of the inner hole in the hanging ring 211 is 0.5-2mm. When the holes are too small, the stitches or needles cannot pass through, and when the holes are too large, the shape of the arched suture scaffold 21 during heat setting is affected.

In this embodiment, the bottom of the inner bracket fixing section 14 of the outer bracket 1 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 221 and 2411 at the lower part 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.

In this embodiment, the inner stent 2 is an integrally formed structure made of a nitinol tube or a nitinol tube by laser cutting and then heat treatment for shaping, as shown in fig. 15 and 16.

Similarly, in the present embodiment, the hemispherical ring frame 12, the contracting transition ring 13 and the inner frame fixing segment 14 of the outer frame 1 are also integrally cut and heat-treated and formed from a memory alloy, such as nitinol or nitinol alloy. Wherein, according to the physiological anatomical data of the patient, the sum of the heights of the hemispherical ring frame 12 and the contraction transition ring 13 is 40-80mm, and the height of the inner frame fixing section is 5-25mm.

The basic thicknesses of the stent struts of the hemispherical ring stent 12, the contracting transition ring 13 and the inner stent fixing section 14, which are the wall thicknesses of the nitinol or nitinol alloy cut tube, are all 0.3 to 0.7mm, the widths of the stent struts of the hemispherical ring stent 12 and the contracting transition ring 13 are 0.5 to 1.5mm, and the width of the stent strut of the inner stent fixing section 14 is 0.3 to 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 stent 12 and the contraction transition ring 13 is formed, namely, the technical effect of softness and rigidity of the lower part of the outer stent is achieved, and the left atrium contraction and relaxation movement can be better adapted.

In addition, in this embodiment, the top of the contraction transition ring 13 is further provided with a polyester fiber connection film connected with the top of the upper elliptical frame 21 of the inner frame 2, so that blood in the left ventricle can be better prevented from overflowing to the left atrium from the gap between the inner frame fixing section 14 and the inner frame 2, and the perivalvular leakage problem can be better prevented.

The heart valve replacement prosthesis fixes the prosthesis in the left atrium by using the outer support frame with the upper support ring, the middle support ring and the lower support ring, so that the prosthesis cannot move in the up-down direction. Specifically, the top end of the prosthesis is provided with the top ring, so that the top of the left atrium is guaranteed to touch the top of the left atrium, the middle part of the prosthesis is provided with a spherical-like ring frame which can fully support the front, the back, the left and the right of the left atrium, and the front, the back, the left and the right of the left atrium are provided with petal transition forms which are symmetrical in the front and the back and asymmetrical in the left and the right, so that the petal transition forms can be well attached to the left atrium close to the mitral annulus. Meanwhile, the outer support is downwards extended to the position of the mitral valve annulus, so the prosthesis cannot move in the left-right direction. More importantly, the asymmetric arrangement of the D-shaped inner support fixing section and the asymmetric contraction transition ring of the outer support 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. And the auxiliary prosthesis can prevent the perivalvular leakage to the maximum extent by sewing the polyester fiber coat and the polyester fiber connecting film.

The inner support of the heart valve replacement prosthesis can form a cylindrical outer frame structure with good rigidity through the action of the arch-shaped sewing frame and the traction ring, and the heart-shaped support frame is arranged, so that the rigidity of the support can be further enhanced, the inner support has an internal damping effect, various loads conducted from the outside, particularly fatigue loads, are consumed, and the service life of the prosthesis is prolonged. Still through the protruding couple structure that inwards tightens up, be convenient for realize loading and retrieving heart valve replacement prosthesis, satisfy the demand of interveneeing the operation, can also guarantee at the in-process of valve prosthesis release, outside conveying system and valve prosthesis are separated gradually, avoid separating the back suddenly and produce an impact force in the twinkling of an eye, result influence operation success rate in resulting in producing electrocardio signal disorder, valve surrounding tissue damage etc. consequence.

The heart valve replacement prosthesis also forms a very important motion isolation effect through the matching of the outer support and the inner support. If the normal opening and closing of the biological membrane are to be ensured after the valve prosthesis is actually installed, it is necessary to ensure that the stent for installing the valve is rigid enough and cannot be influenced by other external loads. At present, aortic valve replacement prostheses are single-layer stents, and mainly because aortic valves are easy to calcify, valve rings for fixing the prostheses are rigid, are not easy to deform and cannot be influenced by the contraction and expansion of the heart, so that biological membranes are directly attached to the stents to achieve a good treatment effect. However, the mitral valve is not easy to calcify, the valve annulus is soft, the prosthesis for replacing the mitral valve is not easy to be fixed on the valve annulus, and if a too rigid support such as a barb, a barb and a hoop is adopted, the method is based on the judgment, although the form of the biological membrane can be maintained, the tissue around the mitral valve is damaged, and the treatment effect is influenced. If a softer stent is adopted, or a single stent is adopted, the myocardium can randomly extrude and deform the stent in the contraction and relaxation processes of the heart, so that the normal opening and closing of the biological membrane are influenced. Therefore, the double-layer valve support mode is adopted, namely the outer support and the inner support are matched, the design has the advantages that the outer support is soft, random matching motion can be carried out along with the contraction and the relaxation of the heart, the inner support is hard and is connected with the outer support through only a plurality of weak fixed points, and then the deformation load of the outer support is not easily transmitted to the inner support, so that the biological membrane is kept in a long-time normal opening and closing condition and is not influenced by the change of the heart during the diastole and the contraction, and the treatment effect and the service life of the valve replacement prosthesis are prolonged.

The heart valve replacement prosthesis also solves the problem of fixing the biological membrane on the mitral valve annulus for a long time, stably and effectively by the arrangement characteristic of the soft upper part and the rigid lower part of the outer support. 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 (10)

1. The heart valve replacement prosthesis is characterized by comprising an outer support and an inner support arranged inside the outer support, wherein a polyester fiber coat is coated outside the outer support, and the inner support is used for fixing a biological membrane.

2. The heart valve replacement prosthesis of claim 1, wherein the outer frame comprises an upper top ring, a hemispherical ring frame, a contraction transition ring and an inner frame fixing section which are arranged from top to bottom, and the hemispherical ring frame is a hemispherical support frame and is used for supporting the inner wall of the 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.

3. The heart valve replacement prosthesis of claim 2, wherein the smooth transition curved surfaces of the contracting transition ring include a main valve support curved surface adjacent to the aortic side and an atrial appendage support curved surface disposed opposite the main valve support curved surface, the main valve support curved surface and the atrial appendage support curved surface having different curved surface angles.

4. The heart valve replacement prosthesis of claim 3, wherein the flexible material of the upper top ring is a high polymer material, the hemispherical support frame supports the anterior and posterior inner walls of the atrium in at least two directions, the cross section of the inner stent fixing section is a D-shaped structure matched with the anatomical shape of the valve annulus, and the fixing mechanism is an expansion leg which penetrates through the row holes of the inner stent from the bottom of the inner stent fixing section.

5. The heart valve replacement prosthesis of any one of claims 2 to 4, wherein the polyester fabric garment is wrapped around the outside of the contraction transition ring and the inner stent anchoring section for preventing blood in the ventricle from escaping into the atrium.

6. The heart valve replacement prosthesis according to claim 5, wherein the inner stent is a cylindrical outer frame structure surrounded by three arch-shaped sewing frames, two adjacent arch-shaped column portions of the three arch-shaped sewing frames are combined to form fixing columns, the lower portions of the three fixing columns are connected through a traction ring, the three arch-shaped sewing frames are internally provided with the retainers, the lower portions of the retainers are fixing rods connected with the traction ring, the upper portions of the retainers are heart-shaped support frames with broken upper edges extending from the upper ends of the fixing rods, the ends with broken upper edges are connected with the upper portions of the arch-shaped sewing frames after being turned back outwards, the fixing columns and the fixing rods are provided with row holes, the traction ring is provided with protruding hooks deviating from the arch-shaped sewing frames, and the protruding hooks are used for being matched and connected with the connecting ends on an external conveying device, so that the heart valve replacement prosthesis is loaded and recovered.

7. The heart valve replacement prosthesis as claimed in claim 6, wherein a plurality of the raised hooks are provided on the traction ring, the plurality of raised hooks are uniformly arranged on the traction ring between the fixing post and the fixing rod, and the raised structures of the raised hooks are tightened towards the central axis direction of the cylindrical outer frame structure;

the top parts of the three arch-shaped sewing frames are provided with hanging rings, and the hanging rings are arranged on the outer side or the inner side of the top parts of the arch-shaped sewing frames.

8. The heart valve replacement prosthesis of claim 6, wherein the hemispherical ring stent, the contracting transition ring, and the inner stent securing segment of the outer stent are integrally formed from nitinol or nitinol, the stent struts of the hemispherical ring stent and the contracting transition ring having a width of 0.5-1.5mm and the stent struts of the inner stent securing segment having a width of 0.3-0.7mm;

the inner stent is integrally formed from nitinol or nitinol alloy.

9. The heart valve replacement prosthesis of claim 6, further comprising a polyester fiber attachment membrane connecting a top of the contraction transition ring and a top of the arch-shaped suture scaffold of the inner scaffold for preventing blood in the ventricle from escaping from the gap between the inner scaffold fixation section and the inner scaffold into the atrium.

10. The heart valve replacement prosthesis of claim 1, wherein the biological membrane is porcine pericardium, porcine aortic valve, bovine pericardium or a synthetic polymer membrane, and the number of the biological membranes is 2, 3 or 6.

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