A heart valve replacement prosthesis

Abstract

The application discloses a heart valve replacement prosthesis and belongs to the field of medical devices. The heart valve replacement prosthesis comprises an outer support and an inner support arranged inside the outer support, the outer support is coated with a polyester fiber coat outside, and the inner support is used for fixing a biological membrane. The outer support supports the inner wall of the atrium and is adapted to the shape of the inner wall of the atrium near the annulus, and is adapted to the shape of the annulus by using a D-shaped structure. The inner support adopts a cylindrical outer frame structure surrounded by three arc-shaped suture supports, the lower part of the inner support is connected through a traction ring, and the three arc-shaped suture supports are internally provided with holding supports. The application adopts the design features of the inner-outer double-layer support, three-ring fixing type, D-shaped structure, motion isolation and lower flexibility and upper rigidity, forms a unique prosthesis structure matched with the physiological structure inside the atrium, and achieves the technical effects of safe and reliable fixing mode, convenient operation and simple processing.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a heart valve replacement prosthesis. BACKGROUND

[0002] Heart valve disease refers to the presence of structural or functional abnormalities in heart valves, and the lesion can involve one valve or multiple valves. In China, the mitral valve is most commonly affected among valvular heart diseases, such as mitral stenosis, mitral regurgitation, or mitral stenosis combined with regurgitation. The aortic valve is the second most commonly affected, such as aortic stenosis, aortic regurgitation, or aortic stenosis combined with regurgitation. In elderly degenerative valvular disease, the most common lesion is in the aortic valve, followed by the mitral valve, such as aortic stenosis, aortic regurgitation, or aortic stenosis combined with regurgitation.

[0003] Heart valve replacement surgery is a type of surgery for patients with heart valve disease. The current main methods include surgical valve replacement and interventional surgery repair or valve replacement. Surgical valve replacement requires thoracotomy, and the heart is cut open under general anesthesia, the diseased valve is cut off, and a normal synthetic or metal valve is sutured to the original valve position. Interventional surgery is a minimally invasive surgery that does not require thoracotomy and is performed under medical intervention through the blood vessels or by a combination of internal and external surgical operations, resulting in less trauma.

[0004] With the development of heart valve surgery, various products for treating mitral valve diseases have also been introduced. The various mitral valve replacement prostheses currently available on the market can be broadly classified as follows: barb fixation, such as Intrepid by Medtronic; hook fixation, such as CardiAQ by Edwards; hoop fixation, such as Sapien M3 by Edwards and Highlife by Pajunk; apex tether fixation, such as tendyne by Abbott; and atrial fixation, such as 4C Medical acquired by Minimally Invasive Cardiovascular Solutions. However, all of the above products have some problems, such as the barb or hook method which can easily cause myocardial electrical signal disorder, mismatched annular shape, etc.; the hoop fixation method is too difficult to operate and is not easy to implement; the apex tether method easily blocks the outflow tract, and the tether adjustment requires a second surgery; and the atrial fixation method has fewer indications, cannot treat stenosis patients, and the left atrial shape is too complex to match, which can easily cause displacement.

[0005] Therefore, the existing heart valve replacement prosthesis has the problems of inconvenient structure, method and use, and defects, and needs to be further improved. How to create a new heart valve replacement prosthesis, which achieves the effect of motion isolation design through the inner and outer double-layer stents, and forms a unique prosthesis structure matched with the physiological structure inside the atrium through the outer stent with the design characteristics of three-ring fixed type, D-shaped anatomical type, lower flexible upper rigid design, and the inner stent with large-span deformation, achieves the technical effects of safe and reliable fixing mode, convenient operation, and simple processing, provides reliable protection for heart intervention valve surgery, and becomes the current industry's much-needed improvement target. SUMMARY

[0006] The technical problem to be solved by the present application is to provide a heart valve replacement prosthesis, which achieves the effect of motion isolation design through the inner and outer double-layer stents, and forms a unique prosthesis structure matched with the physiological structure inside the atrium through the outer stent with the design characteristics of three-ring fixed type, D-shaped anatomical type, lower flexible upper rigid design, and the inner stent with large-span deformation, achieves the technical effects of safe and reliable fixing mode, convenient operation, and simple processing, provides reliable protection for heart intervention valve surgery.

[0007] To solve the above technical problems, the present application provides a heart valve replacement prosthesis, which comprises an outer stent and an inner stent arranged inside the outer stent, and a polyester fiber coat arranged outside the outer stent, and the inner stent is used for fixing a biological membrane.

[0008] Further improvement, the outer stent comprises an upper top ring, a hemispherical ring frame, a contraction transition ring and an inner stent fixing section arranged from top to bottom, the hemispherical ring frame is a hemispherical support frame for supporting the inner wall of the atrium, the upper top ring is an annular ring formed by connecting the vertices of the hemispherical support frame in sequence with flexible material, for abutting against the top of the atrium, the contraction transition ring is a smooth transition curved surface formed by smoothly contracting the bottom of the hemispherical support frame inward, for adapting to the shape of the atrial wall near the annulus, and the inner stent fixing section is a cylindrical structure extended downward from the bottom of the contraction transition ring, for adapting to the annulus shape, and the bottom of the inner stent fixing section is provided with a fixing mechanism connected with the inner stent.

[0009] Further improvement, the smooth transition curved surface of the contraction transition ring comprises a main valve support curved surface close to the aortic side and an auricle support curved surface arranged opposite to the main valve support curved surface, and the curved surface included angles of the main valve support curved surface and the auricle support curved surface are different.

[0010] Further improvement, the flexible material of the upper top ring adopts high molecular polymer material, the semi-spherical support frame forms support for the front and rear inner walls of atrium in at least front and rear directions, the cross section of the inner support fixed section adopts D-shaped structure matching the anatomical form of the valve ring, and the fixing mechanism is an expansion foot passing through the row hole of the inner support from the bottom of the inner support fixed section.

[0011] Further improvement, the polyester fiber outer cover is wrapped outside the shrinkage transition ring and the inner support fixed section to prevent blood in the ventricle from overflowing into the atrium.

[0012] Further improvement, the inner support adopts a cylindrical outer frame structure surrounded by three arched suture frames, the adjacent arch column portions of the three arched suture frames are combined into fixed columns, the lower parts of the three fixed columns are connected through a traction ring, the arched interiors of the three arched suture frames are each provided with a holding frame, the lower part of the holding frame is a fixed rod connected with the traction ring, the upper part of the holding frame is a heart-shaped support frame with an upper edge broken off extending out of the upper end of the fixed rod, the end part after the upper edge is broken off is folded back outward and connected with the upper part of the arched suture frame, the fixed columns and the fixed rod are each provided with a row hole, the traction ring is provided with a protruding hook deviated from the arched suture frame, the protruding hook is used for matching connection with a connecting end on an external conveying device to realize loading and recovery of the heart valve replacement prosthesis.

[0013] Further improvement, a plurality of protruding hooks are arranged on the traction ring, the plurality of protruding hooks are uniformly arranged on the traction ring between the fixed columns and the fixed rod, and the protruding structures of the protruding hooks are all tightened towards the central axis direction of the cylindrical outer frame structure.

[0014] The top parts of the three arched suture frames are each provided with a lifting ring, and the lifting ring is arranged on the outside or the inside of the top part of the arched suture frame.

[0015] Further improvement, the semi-spherical ring frame, the shrinkage transition ring and the inner support fixed section of the outer support are integrally processed and formed by using nickel-titanium alloy or nickel-titanium memory alloy, the width of the support rod of the semi-spherical ring frame and the shrinkage transition ring is 0.5-1.5 mm, and the width of the support rod of the inner support fixed section is 0.3-0.7 mm.

[0016] The inner support is integrally processed and formed by using nickel-titanium alloy or nickel-titanium memory alloy.

[0017] Further improvement, the heart valve replacement prosthesis further comprises a polyester fiber connecting film, the polyester fiber connecting film connects the top part of the shrinkage transition ring and the top part of the arched suture frame of the inner support, to prevent blood in the ventricle from overflowing into the atrium through the gap between the inner support fixed section and the inner support.

[0018] Further improvement, the biological membrane adopts pig pericardium, pig aortic valve, cow pericardium or artificial synthetic polymer membrane, and the number of the biological membrane is 2 pieces, 3 pieces or 6 pieces.

[0019] After adopting such design, the present application has at least the following advantages:

[0020] 1. The outer support of the heart valve replacement prosthesis in the present application forms a three-ring fixed structure by using the upper support ring, the middle support ring and the lower support ring, so that the prosthesis is stably and reliably fixed in the atrium and prevented from moving in the up-down direction. Meanwhile, due to the setting of the inner support fixing section of the outer support, the inner support fixing section extends to the position of the mitral valve annulus, so that the prosthesis cannot move in the left-right direction. In addition, due to the asymmetric setting of the D-shaped inner support fixing section of the outer support and the asymmetric contraction transition ring, the prosthesis has strong anti-rotation ability, and the overall fixation problem of the prosthesis is perfectly solved by the structure of the outer support.

[0021] In addition, due to the different width settings of the upper and lower support rods of the outer support, the setting feature of lower flexibility and upper rigidity is formed, so that the prosthesis not only adapts to the periodic morphological changes of the mitral valve, but also has sufficient support force, thereby solving the problem of long-term, stable and effective fixation of the biological membrane to the position of the mitral valve annulus, and achieving perfect fixation in the atrium without affecting the contraction and diastolic movement of the atrium.

[0022] 2. The inner support of the heart valve replacement prosthesis in the present application adopts a cylindrical outer frame structure surrounded by an arch-shaped suture frame, and a circular traction ring is arranged at the lower part of the fixing column, which not only improves the rigidity of the cylindrical outer frame structure, but also facilitates the matching connection of the protruding hooks on the inner support with the connecting end of the external conveying equipment, so as to realize the loading and recovery of the heart valve replacement prosthesis and meet the needs of interventional surgery. In addition, a heart-shaped retaining frame is arranged inside the arch-shaped suture frame, which completely breaks through the constraint of the existing diamond single-cell structure of the support, so that the design freedom of the cutting design drawing is greater, and the inner support can realize large-span deformation during heat treatment and shaping. In addition, due to the S-shaped structure formed by the upper folding of the heart-shaped retaining frame, the inner support has the effect of internal damping to consume various loads conducted from the outside, especially fatigue loads, thereby improving the service life of the prosthesis and increasing the production qualification rate of the inner support.

[0023] In addition, by setting the protruding hooks as inwardly tightened structures, it can be ensured that the external conveying system and the valve prosthesis gradually separate during the release of the valve prosthesis, rather than suddenly disconnecting, so as to avoid the sudden generation of an impact force after sudden disconnection, which may cause consequences such as cardiac electrical signal disorder and damage to the tissue around the valve during surgery, thereby improving the success rate of surgery.

[0024] 3. The heart valve replacement prosthesis of the present application prevents backflow of blood from the left ventricle to the left atrium by sewing a polyester fiber outer cover on the lower part of the outer support. By connecting a polyester fiber connecting membrane on the top of the contraction transition ring to the top of the arched suture frame of the inner support, the overflow of blood from the inner support fixed section and the gap between the inner support to the left atrium can be better prevented, and the occurrence of paravalvular leakage can be better prevented.

[0025] 4. The heart valve replacement prosthesis of the present application forms a motion isolation effect by the cooperation of the outer support and the inner support. The outer support is relatively soft and can perform random matching motion with the contraction and relaxation of the heart. The inner support is relatively hard and supports the natural opening and closing of the biological membrane. The deformation load of the outer support is not easily transmitted to the inner support, the biological membrane can be normally opened and closed for a long time, is not affected by the changes of the heart during diastole and systole, and greatly prolongs the treatment effect and service life of the valve replacement prosthesis.

[0026] 5. The heart valve replacement prosthesis of the present application is safe and reliable in fixation, does not damage any tissue structure, overcomes the problems that barbs and hooks can cause electrical signal disorder, hoop rings can cause tendon rupture, and tethers can cause obstruction of the outflow tract, and the presence of the apex pad may cause the risk of heart apex bleeding. The heart valve replacement prosthesis of the present application can be implemented by the method of transfemoral vein + transseptal, or by the method of transapical, which is simple and easy to operate. At the same time, it is also relatively easy to store and transport during surgery. The heart valve replacement prosthesis of the present application is easy to process and form, and can realize stable mass production. BRIEF DESCRIPTION OF DRAWINGS

[0027] The above is only a summary of the technical solutions of the present application. In order to more clearly understand the technical means of the present application, the following will further describe the present application in detail in combination with the drawings and specific embodiments.

[0028] Figure 1 is a structural front view of the heart valve replacement prosthesis of the present application.

[0029] Figure 2 is a structural side view of the heart valve replacement prosthesis of the present application.

[0030] Figure 3 is a structural rear view of the heart valve replacement prosthesis of the present application.

[0031] Figure 4 is a structural top view of the heart valve replacement prosthesis of the present application.

[0032] Figure 5 is a three-dimensional structural view of the heart valve replacement prosthesis of the present application.

[0033] Figure 6 is a structural front view of the outer support of the heart valve replacement prosthesis of the present application.

[0034] Figure 7 is a structural side view schematic diagram of the outer stent of the heart valve replacement prosthesis of the present application.

[0035] Figure 8 is a structural top view schematic diagram of the outer stent of the heart valve replacement prosthesis of the present application.

[0036] Figure 9 is a three-dimensional structural schematic diagram of the outer stent of the heart valve replacement prosthesis of the present application.

[0037] Figure 10 is a structural front view schematic diagram of the inner stent of the heart valve replacement prosthesis of the present application.

[0038] Figure 11 is a structural side view schematic diagram of the inner stent of the heart valve replacement prosthesis of the present application.

[0039] Figure 12 is a three-dimensional structural schematic diagram of the inner stent of the heart valve replacement prosthesis of the present application.

[0040] Figure 13 is a structural top view schematic diagram of the inner stent of the heart valve replacement prosthesis of the present application.

[0041] Figure 14 is a schematic diagram of the unfolded structure of the inner stent of the heart valve replacement prosthesis of the present application.

[0042] Figure 15 is a schematic diagram of the tube structure after laser cutting of the inner stent of the heart valve replacement prosthesis of the present application.

[0043] Figure 16 is a schematic diagram of the tube unfolded structure after laser cutting of the inner stent of the heart valve replacement prosthesis of the present application. DETAILED DESCRIPTION

[0044] The present application is based on the research of the existing product fixing method, and finds that the core problem of the valve replacement prosthesis is: how to firmly, stably and unaffectedly fix the biological membrane at the position of the valve ring, and not to affect the contraction and diastolic movement of the heart. On this basis, the present application creatively proposes a three-ring fixed type mitral valve replacement prosthesis structure. The specific implementation is as follows.

[0045] This embodiment takes the mitral valve replacement prosthesis as an example to introduce the technical scheme of the present application in detail, which should not be understood as any limitation of the present application. For example, the present application can also be used for tricuspid valve replacement prosthesis, aortic valve prosthesis, etc.

[0046] Referring to the accompanying drawings Figures 1 to 5As shown, the embodiment of the mitral valve replacement prosthesis comprises an outer stent 1 and an inner stent 2. The inner stent 2 is arranged inside the outer stent 1, and the bottom of the outer stent 1 is fixedly connected with the bottom of the inner stent 2.

[0047] Referring to the drawings Figures 6 to 9 As shown, the outer stent 1 in the embodiment comprises an upper top ring 11, a hemispherical ring stent 12, a contraction transition ring 13, and an inner stent fixed section 14 arranged from top to bottom. The hemispherical ring stent 12 in the embodiment is a hemispherical support frame for supporting the inner wall of the left atrium. The hemispherical shape is similar to a hemispherical shape, which can be an ellipsoidal shape, or a semi-hemispherical shape, etc. The hemispherical ring stent 12 mainly matches the internal form of the left atrium, and supports the inner wall of the left atrium in six directions of up and down, left and right, and front and back, etc., to ensure that the position of the mitral valve replacement prosthesis does not shift and rotate during the movement of the heart. A certain gap can be left in the left and right directions to ensure the smooth passage of the four pulmonary veins.

[0048] In order to be simple and convenient to prepare, the hemispherical ring stent 12 supports the inner wall of the left atrium in at least the front and back directions to meet the balance of the manufacturing and support effect. In this way, the hemispherical ring stent 12 supports the inner wall of the left atrium to form the middle support ring in the three-ring fixed type of the outer stent.

[0049] The upper top ring 11 is an annular ring formed by connecting the vertices of the hemispherical support frame in sequence with 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, and is preferably polyethylene, ultra-high molecular weight polyethylene, polytetrafluoroethylene, polyester fiber, etc. The upper top ring 11 can be a single strand rope or a braided rope, and the thickness of the rope is between 0.5-2mm. The upper top ring 11 can be circular, oval, or any spatial closed loop curve. The upper top ring 11 must be ensured to contact the top of the left atrium to form a vertical support point, i.e., the upper support ring in the three-ring fixed type of the outer stent.

[0050] The contraction transition ring 13 is a smooth transition curved surface formed by smoothly contracting the bottom of the hemispherical support frame inward, and is used for adapting to the form of the inner wall of the atrium near the annulus. The smooth transition curved surface of the contraction transition ring 13 comprises a main valve support curved surface 131 close to the aortic side and an auricle support curved surface 132 opposite to the main valve support curved surface 131. The main valve support curved surface 131 is located on the side close to the aorta during surgical installation, which can match the form of the left atrium close to the aortic valve, and can not press the aortic valve during the contraction and diastolic movement of the heart. The auricle support curved surface 132 is located on the side close to the left auricle during surgical installation, and matches the form of the left atrium.

[0051] Specifically, in order to better adapt to the anatomical structure of the lower part of the left atrium near the annulus, the included angles of the main valve support curved surface 131 and the auricle support curved surface 132 are different. As the included angle of the main valve support curved surface 131 is 40-80 degrees, and the included angle of the auricle support 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, further improving the adaptability of the outer stent to the lower part of the left atrium.

[0052] In this way, the main valve support curved surface 131 and the auricle support curved surface 132 and the ordinary connecting petal curved surface therebetween can form a smooth transition surface of the contraction transition ring 13. The complex curved surface form of the smooth transition surface can be well fitted on the left atrium near the annulus of the mitral valve, and is also an important fixed structure for preventing the replacement prosthesis from moving downward, that is, the lower support ring in the three-ring fixation of the outer stent.

[0053] The inner stent fixed segment 14 is a cylindrical structure extending downward from the bottom of the contraction transition ring 13, which is used to adapt to the annulus form of the mitral valve. In the embodiment, the cross section of the inner stent fixed segment 14 adopts a D-shaped structure matching the anatomical form of the annulus of the mitral valve, as shown in the accompanying drawings. Figure 4 The D-shaped structure can fully adapt to the annulus form of the mitral valve of all patients, preventing the occurrence of paravalvular leakage due to mismatching. And according to different patient ages, genders, races, disease types, etc., multiple specifications of D-shaped structures can be set.

[0054] In order to adapt to the fact that the annulus of the mitral valve belongs to a saddle-shaped structure, the cylindrical structure of the inner stent fixed segment 14 needs to have a certain height. In the embodiment, the height h of the inner stent fixed segment 14 should be controlled between 5-25 mm, so as to achieve the occlusion of the mitral valve and ensure that there is no paravalvular leakage problem.

[0055] In order to better prevent the occurrence of paravalvular leakage problem, the outer sides of the contraction transition ring 13 and the inner stent fixed segment 14 are wrapped with a layer of polyester fiber clothing, that is, starting from the bottom of the inner stent fixed segment 14 and ending at the lower edge of the hemispherical ring frame 12, which is used to occlude the left ventricular blood and prevent backflow to the left atrium. It should be noted that the length of the polyester fiber clothing should not be too long, so as not to block the pulmonary vein passage on both sides of the hemispherical ring frame 12.

[0056] In the embodiment, the inner stent 2 is used to connect a biological membrane, which can be bovine pericardium, porcine pericardium or porcine aortic valve, and of course can also be an artificial polymer membrane. The biological membrane can be 2 pieces, 3 pieces or 6 pieces, and is preferably 3 pieces.

[0057] Referring to the accompanying drawings Figures 10 to 14As shown, the inner stent 2 in the embodiment adopts a cylindrical outer frame structure surrounded by three arched suture frames 21, and the adjacent arch column portions of the three arched suture frames 21 are combined into fixed columns 22, and the fixed columns 22 are provided with row holes 221. The lower parts of the three fixed columns 22 are connected through traction rings 23, the traction rings 23 can keep the cylindrical shape of the inner stent 2, and good enough stiffness of the cylindrical outer frame structure. The traction rings 23 are provided with protruding hooks 231 deviated from the arched suture frames 21, the protruding hooks 231 are used for matching connection with the connecting end on the external conveying equipment, to realize loading and recovery of the heart valve replacement prosthesis and the inner stent thereof.

[0058] The arched interiors of the three arched suture frames 21 are provided with holding frames 24, the lower parts of the holding frames 24 are fixed rods 241 connected with the traction rings 23, and the fixed rods 241 are provided with row holes 2411. The upper parts of the holding frames 24 are heart-shaped support frames 242 extending out from the upper ends of the fixed rods 241, and the two ends after the upper edge is disconnected are respectively folded back outward and connected with the upper parts of the arched suture frames 21. In this way, the connection between the heart-shaped support frames 242 and the arched suture frames 21 appears two symmetrical S shapes, instead of being straightened, and the S shape can ensure that the entire holding frame 24 has a certain elasticity, that is, the entire inner stent has a certain internal elasticity under the condition of keeping enough stiffness, to form a certain damping effect, thereby consuming various loads conducted from the outside, especially fatigue loads, thereby improving the service life of the inner stent.

[0059] The holding frames 24 can provide enough rigid support for the entire inner stent together with the arched suture frames 21, the fixed rods 241 together with the fixed columns 22 provide fixed positions for the connection between the outer stent 1 and the inner stent 2, and the connection between the fixed rods 241 and the traction rods 23 provides further support for keeping the cylindrical shape of the inner stent 2. The design of the heart-shaped support frames 242 is more suitable for large-span shape changes than the existing rhombic single cell structure, while keeping enough connection strength, to provide strong guarantee for improving the production qualification rate of the inner stent.

[0060] The widths of the fixed columns 22 and the fixed rods 241 are both wider, 2-4 times, preferably 3 times, the width of other parts, for example, if the line width of the arched suture frame 21 is 0.5 mm, the preferred width of the fixed column 22 is 1.5 mm. The fixed columns 22 and the fixed rods 241 provide effective support for keeping enough stiffness of the entire inner stent structure, so that the biological membrane can normally open and close after being implanted into the patient's body, without being affected by the contraction and diastolic movement of the heart.

[0061] The fixed column 22 and the fixed rod 241 are uniformly spaced, wherein the fixed column 22 is used for the connection of the inner support 2 and the outer support 1, and is also used for fixing the biofilm; the fixed rod 241 is only used for the connection of the inner support 2 and the outer support 1. Therefore, the number of the row holes 221 on the fixed column 22 is greater than or equal to the number of the row holes 2411 on the fixed rod 241. For example, the number of the row holes 221 on the fixed column 22 is 4-10, and the number of the row holes 2411 on the fixed rod 241 is 1-7. Preferably, the number of the row holes 221 on the fixed column 22 is 5, and the number of the row holes 2411 on the fixed rod 241 is 4. Specifically, the number of the row holes should not be too much, otherwise it will affect the overall rigidity of the support. Moreover, the more the number of the row holes, the longer the length of the fixed column 22 and the fixed rod 241, and the greater the rigidity of the inner support, which makes it more difficult to produce the product. The functions of the row holes include: first, when the fixed column 22 fixes the biofilm, the row holes can be used as pinholes to provide sufficient fixing positions, so as to ensure that the biofilm is fixed firmly and will not move up and down along the fixed column 22; second, the row holes provide fixing positions for the connection of the inner and outer supports, the supporting legs of the outer support 1 can pass through the row holes, and then the supporting legs are fixed to the inner support 2 through deformation and interference, or the inner support 2 and the outer support 1 can be sewn together through the row holes, or they can be welded together.

[0062] In the embodiment, the traction ring 23 is provided with a plurality of protruding hooks 231, and the plurality of protruding hooks 231 are uniformly arranged on the traction ring 23 between the fixed column 22 and the fixed rod 241. The number of the protruding hooks 231 can be the same as or twice the sum of the number of the fixed column and the number of the fixed rod. The protruding hooks 231 are in the form of a half ring, which can be half of a circle, an ellipse, a triangle or other polygonal shapes. The function of the protruding hooks 231 is to provide an important connection position when the inner support 2 or the entire valve prosthesis is stored (interventional surgery, the product will be stored in a thin tube). The connection end of the external delivery system can be provided with a structure matched with the protruding hooks 231, which can be embedded in the hooks 231 and hung on the hooks 231, so that the inner support 2 or the valve prosthesis can be pulled in the inside of the thin tube for storage.

[0063] The convex structure of the convex hook 231 in this embodiment is tightened towards the central axis direction of the cylindrical outer frame structure. The included angle of the inwardly tightened convex hook 231 is 0-30°. The inwardly tightened design aims to ensure that the external delivery system and the valve prosthesis gradually separate during the release of the valve prosthesis, rather than suddenly separate, avoiding the sudden impact force generated when the valve prosthesis and the delivery system suddenly separate, which may cause cardiac electrical signal disorder, damage to the tissue around the valve, and other consequences during the operation. The inwardly tightened structure can maximize the success rate of the operation and achieve unexpected technical effects.

[0064] The top of each of the three arched suture frames 21 is provided with an eye 211 arranged on the outside or inside of the middle of the top of the arched suture frame 21. The main function of the eye 211 is to fix the position of the biological membrane or connecting membrane when suturing the biological membrane or connecting membrane, avoiding the biological membrane or connecting membrane from slipping along the outer frame of the arched suture frame 21, resulting in unstable structure. The inner hole of the eye 211 has a diameter ranging from 0.5-2mm. If the hole is too small, the suture or needle cannot pass through, and if the hole is too large, it will affect the shape of the arched suture frame 21 during heat setting.

[0065] The bottom of the inner support fixed section 14 of the outer support 1 in this embodiment is provided with a fixing mechanism 141 connected with the inner support 2. The fixing mechanism 141 is an expansion foot member passing through the row holes 221, 2411 of the lower part of the inner support 2 from the bottom of the inner support fixed section 14, which is stable and reliable, and easy to operate.

[0066] The inner support 2 in this embodiment is made of a nickel-titanium alloy tube or a nitinol alloy tube, which is cut by laser and then shaped by heat treatment, like the one shown in Figs. 1-2. Figure 15 and 16

[0067] Similarly, the hemispherical ring frame 12, the shrinkage transition ring 13 and the inner support fixed section 14 of the outer support 1 in this embodiment are also made of a nickel-titanium alloy or a nickel-titanium alloy, which are integrally cut and heat treated. Among them, according to the patient's anatomical data, the height of the hemispherical ring frame 12 and the shrinkage transition ring 13 is 40-80mm, and the height of the inner support fixed section is 5-25mm.

[0068] ​The base thickness of the support rods of the half-sphere ring frame 12, the shrinkage transition ring 13 and the inner support fixed section 14 is the wall thickness of the cut pipe of the nickel-titanium alloy or the nickel-titanium alloy, which is 0.3-0.7mm, the width of the support rods of the half-sphere ring frame 12 and the shrinkage transition ring 13 is 0.5-1.5mm, and the width of the support rods of the inner support fixed section 14 is 0.3-0.7mm. In this way, since the width of the support rods of the inner support fixed section 14 is narrow, a part that is softer than the half-sphere ring frame 12 and the shrinkage transition ring 13 is formed, that is, the technical effect of being soft at the upper part and rigid at the lower part of the outer support is achieved, and the left atrium contraction and diastole movement can be better adapted.

[0069] In addition, the top of the shrinkage transition ring 13 in the embodiment is further provided with a polyester fiber connecting film connected with the top of the upper elliptical frame 21 of the inner support 2, so that the overflow of blood from the gap between the inner support fixed section 14 and the inner support 2 to the left atrium can be better prevented, and the problem of paravalvular leakage can be better avoided.

[0070] The heart valve replacement prosthesis of the application is fixed inside the left atrium by using the outer support with the upper, middle and lower three support rings, so that the prosthesis will not move in the up-down direction. Specifically, the upper top ring is arranged at the top end of the prosthesis to ensure that it touches the top of the left atrium, the middle part adopts a ball-shaped ring frame to support the left atrium in front, back, left and right directions, and the lower part is provided with front-back symmetric and left-right asymmetric petal transition forms, so that it is well fitted on the left atrium near the mitral annulus. At the same time, since the outer support extends to the position of the mitral annulus, the prosthesis itself will not move in the left-right direction. More importantly, the asymmetric setting of the D-shaped inner support fixed section of the outer support and the asymmetric shrinkage transition ring, combined with the connection of the inner support and the outer support, can make the prosthesis have strong anti-rotation ability, directly inhibit the rotation of the prosthesis from the structure, and perfectly solve the overall fixation problem of the prosthesis. By sewing the polyester fiber outerwear and the polyester fiber connecting film, the prosthesis can be assisted to prevent paravalvular leakage as much as possible.

[0071] The inner support of the heart valve replacement prosthesis can form a cylindrical outer frame structure with good rigidity through the action of the arched suture frame and the traction ring, and through the setting of the heart-shaped support frame, the rigidity of the support can be further strengthened, and the inner support can have the effect of internal damping, consuming various loads conducted from the outside, especially fatigue loads, thereby improving the service life of the prosthesis. Through the inwardly tightened protruding hook structure, the loading and recovery of the heart valve replacement prosthesis can be facilitated, the needs of the interventional surgery can be met, and it can also be ensured that the external delivery system and the valve prosthesis are gradually separated during the release of the valve prosthesis, avoiding the sudden separation of the external delivery system and the valve prosthesis, which can cause an instantaneous impact force, resulting in the disturbance of the electrocardio signal during the surgery, the damage of the tissue around the valve, and other consequences affecting the success rate of the surgery.

[0072] The heart valve replacement prosthesis of the present application also forms a very important movement isolation effect through the cooperation of the outer stent and the inner stent. After the valve prosthesis is actually installed, in order to ensure that the biological membrane can normally open and close, it is necessary to ensure that the stent for installing the valve is both rigid enough and cannot be affected by other external loads. At present, the aortic valve replacement prosthesis is a single-layer stent, mainly because the aortic valve is prone to calcification, the annulus for fixing the prosthesis is rigid and not easy to deform, and will not be affected by the heart systole, so the biological membrane is directly attached to the stent, which achieves good treatment effect. The mitral valve is different, which is not prone to calcification, and the annulus is soft. The prosthesis for replacing the mitral valve is not easy to fix to the annulus. If a too rigid stent is used, such as adding barbs, hooks and hoop rings, although the shape of the biological membrane can be maintained, the surrounding tissue of the mitral valve will be damaged, thereby affecting the treatment effect. If a relatively soft stent is used, and it is single-layer, in the process of heart contraction and diastole, the myocardium will randomly deform the stent, thereby affecting the normal opening and closing of the biological membrane. Therefore, the present application adopts a double-layer stent, that is, an outer stent and an inner stent are cooperated. The advantage of this design is that the outer stent is soft and can randomly match the movement of the heart contraction and diastole. The inner stent is relatively hard and is connected to the outer stent only at several non-fixed points. Therefore, the deformation load of the outer stent is not easily transmitted to the inner stent, so that the biological membrane can maintain normal opening and closing for a long time, is not affected by the changes of heart diastole and systole, and prolongs the treatment effect and service life of the valve replacement prosthesis.

[0073] The heart valve replacement prosthesis of the present application also solves the problem of long-term, stable and effective fixation of the biological membrane to the position of the mitral valve annulus through the setting feature of the outer stent being soft at the lower part and rigid at the upper part. The person skilled in the art knows that the stent structure of the replacement prosthesis in the left atrium must have sufficient support, which will affect the systole and diastole of the left atrium if it is too hard, and will cause the prosthesis to shift and even cause the prosthesis to periodically fluctuate, thereby causing serious paravalvular leakage. Therefore, the D-shaped fixed section of the outer stent of the present application is soft due to the narrow width of the stent rod, and the whole belongs to a soft structure, which can adapt to the periodic morphological changes of the mitral valve. The upper hemispherical ring frame and the contraction transition ring are hard due to the wide width of the stent rod, and the whole belongs to a hard structure, which can ensure sufficient support and cannot damage the left atrium. Therefore, the heart valve replacement prosthesis of the present application can be perfectly fixed in the atrium without affecting the systole and diastole movement of the atrium.

[0074] In the description of the present application, it should be noted that the terms "upper", "lower", "front", "back", "left", "right" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0075] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0076] The above is only the preferred embodiment of the present application, and does not limit the present application in any form. Those skilled in the art can make some simple modifications, equivalent changes or modifications by using the technical content disclosed above, which are all within the protection scope of the present application.

Claims

1. A heart valve replacement prosthesis, characterized in that, The outer support is coated with a polyester fiber coat outside, and the inner support is used for fixing biological membrane; The outer support comprises an upper top ring, a hemispherical ring support, a shrinkage transition ring and an inner support fixing section arranged from top to bottom, the hemispherical ring support is a hemispherical support frame for supporting the inner wall of atrium, the upper top ring is an annular ring formed by connecting the vertices of the hemispherical support frame in sequence with flexible material, for abutting against the top of atrium, the shrinkage transition ring is a smooth transition curved surface formed by smoothly shrinking the bottom of the hemispherical support frame inward, for adapting to the shape of the inner wall of atrium near the annulus; The inner support fixing section is a cylindrical structure extended downward from the bottom of the shrinkage transition ring, for adapting to the annulus shape, the bottom of the inner support fixing section is provided with a fixing mechanism connected with the inner support, the smooth transition curved surface of the shrinkage transition ring comprises a main valve support curved surface close to the aorta side and an auricle support curved surface arranged opposite to the main valve support curved surface, the curved surface included angle of the main valve support curved surface and the auricle support curved surface is different; The hemispherical ring support, the shrinkage transition ring and the inner support fixing section of the outer support are integrally processed and formed by nickel-titanium alloy or nickel-titanium alloy, the width of the support rods of the hemispherical ring support and the shrinkage transition ring is 0.5-1.5mm, the width of the support rods of the inner support fixing section is 0.3-0.7mm, and the width of the support rods of the inner support fixing section is smaller than the width of the support rods of the hemispherical ring support and the shrinkage transition ring, forming a structure of lower flexibility and upper rigidity.

2. The cardiac valve replacement prosthesis of claim 1, wherein, The flexible material of the upper top ring adopts high molecular polymer material, the hemispherical support frame forms support to the front and rear inner walls of atrium in at least two directions, the cross section of the inner support fixing section adopts D-shaped structure matched with the annulus anatomical shape, and the fixing mechanism is an expansion foot passing through the row holes of the inner support from the bottom of the inner support fixing section.

3. The cardiac valve replacement prosthesis of claim 1 or 2, characterized in that The polyester fiber coat is wrapped outside the shrinkage transition ring and the inner support fixing section, for preventing blood in the ventricle from overflowing into the atrium.

4. The cardiac valve replacement prosthesis of claim 3, wherein, The inner support adopts a cylindrical outer frame structure surrounded by three arched suture supports, the adjacent arch column portions of the three arched suture supports are combined into fixed columns, the lower parts of the three fixed columns are connected through a traction ring, the arched interiors of the three arched suture supports are each provided with a holding support, the lower part of the holding support is a fixed rod connected with the traction ring, and the upper part of the holding support is a heart-shaped support frame with the upper edge broken off extended from the upper end of the fixed rod, the end part after the upper edge broken off is connected with the upper part of the arched suture support after being folded back outward, the fixed columns and the fixed rods are each provided with row holes, the traction ring is provided with a protruding hook deviated from the arched suture support, the protruding hook is used for matching connection with a connecting end on an external conveying device, to realize loading and recovery of a heart valve replacement prosthesis.

5. The cardiac valve replacement prosthesis of claim 4, wherein, A plurality of protruding hooks are arranged on the traction ring, the plurality of protruding hooks are uniformly arranged on the traction ring between the fixed columns and the fixed rods, and the protruding structures of the protruding hooks are all tightened towards the central axis direction of the cylindrical outer frame structure. The top of each of the three arc-shaped suture frames is provided with a lifting ring, which is arranged on the outer side or the inner side of the top of the arc-shaped suture frame.

6. The cardiac valve replacement prosthesis of claim 4, wherein, The inner support is integrally processed and formed by using a nickel-titanium alloy or a nickel-titanium alloy.

7. The cardiac valve replacement prosthesis of claim 4, wherein, The heart valve replacement prosthesis further comprises a polyester fiber connecting membrane connecting the top of the contraction transition ring and the top of the arc-shaped suture frame of the inner support, for preventing blood in the ventricle from overflowing from the gap between the inner support fixed section and the inner support into the atrium.

8. The heart valve replacement prosthesis of claim 1, wherein, The biological membrane is made of a pig pericardium, a pig aortic valve, a cow pericardium or an artificial synthetic polymer membrane, and the number of the biological membrane is 2, 3 or 6.

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