A heart valve replacement prosthesis and its outer support

Abstract

The application discloses a heart valve replacement prosthesis and an outer support thereof, and belongs to the field of medical devices. The outer support comprises an upper top ring, a hemispherical ring support, a contraction transition ring and an inner support fixed section arranged from top to bottom. The hemispherical ring support 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 upper vertices of the hemispherical ring support in sequence with flexible material, and is used 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 ring support inward, and is used for adapting to the shape of the inner wall of the atrium near the valve annulus. The inner support fixed section is a cylindrical structure extended downward from the bottom of the contraction transition ring, and is used for adapting to the shape of the valve annulus. The application adopts the design features of three-ring fixed 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 and its outer support. BACKGROUND

[0002] Heart valve disease refers to the presence of structural or functional abnormalities in the heart valves, and the lesions 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 patients with 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 removed, and a normal synthetic or metal valve is sutured to the original valve position. Interventional surgery is a minimally invasive procedure that does not require thoracotomy and is performed under endovascular conditions or by a combination of endovascular and surgical procedures, 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 fixation methods which can easily cause myocardial electrical signal disorders, mismatched valve annulus shapes, and heart rupture; the hoop fixation method which is too difficult to operate and is not easy to implement; the apex tether fixation method which easily blocks the outflow tract and requires a second surgery for tether adjustment; and the atrial fixation method which has fewer indications, cannot treat stenosis patients, and has a complex left atrial shape that is prone to displacement.

[0005] It can be seen that the existing heart valve replacement prosthesis has the disadvantages of inconvenient structure, method and use, and needs to be further improved. How to create a new heart valve replacement prosthesis and its outer support, so that it is safe and reliable in fixation, easy to operate, and simple to process, provides reliable protection for heart valve surgery, and becomes the current industry's goal for improvement. SUMMARY

[0006] The technical problem solved by the present application is to provide an outer stent of a heart valve replacement prosthesis, which forms a unique outer stent structure matching the physiological structure inside the atrium by adopting a three-ring fixation design, a D-shaped anatomical design, a motion isolation design, and a lower flexible and upper rigid design feature, achieving the technical effects of safe and reliable fixation, convenient operation, and simple processing, and providing reliable protection for heart valve surgery.

[0007] To solve the above technical problems, the present application provides an outer stent of a heart valve replacement prosthesis, which comprises an upper top ring, a hemispherical ring frame, a contraction transition ring, and an inner stent fixing segment 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 segment is a cylindrical structure extending downward from the bottom of the contraction transition ring, for adapting to the annulus shape, and the bottom of the inner stent fixing segment is provided with a fixing mechanism connected with the inner stent.

[0008] Further improvement, the hemispherical support frame forms support for the front and rear inner walls of the atrium in at least two directions.

[0009] Further improvement, the flexible material of the upper top ring adopts a high molecular polymer material.

[0010] Further improvement, the cross section of the inner stent fixing segment adopts a D-shaped structure matching the anatomical shape of the annulus.

[0011] Further improvement, the smooth transition curved surface of the contraction transition ring includes 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.

[0012] Further improvement, the curved surface included angle of the main valve support curved surface is 40-80 degrees, and the curved surface included angle of the auricle support curved surface is 5-30 degrees.

[0013] Further improvement, the height of the hemispherical ring frame and the contraction transition ring is 40-80 mm, and the height of the inner stent fixing segment is 5-25 mm.

[0014] Further improvement, the semi-sphere ring holder, the shrink transition ring and the inner holder fixing section are integrally processed and formed by using nickel-titanium alloy or nickel-titanium alloy, the base thickness of the holder rod of the semi-sphere ring holder, the shrink transition ring and the inner holder fixing section is 0.3-0.7mm, the width of the holder rod of the semi-sphere ring holder and the shrink transition ring is 0.5-1.5mm, and the width of the holder rod of the inner holder fixing section is 0.3-0.7mm.

[0015] Further improvement, the fixing mechanism is an expansion foot member passing through the inner holder hole of the bottom of the inner holder fixing section.

[0016] As another improvement of the present application, the present application further provides a heart valve replacement prosthesis, comprising the outer holder of the heart valve replacement prosthesis and the inner holder for fixing the biological membrane, the inner holder is arranged inside the outer holder, and the bottom of the inner holder fixing section of the outer holder is fixedly connected with the bottom hole of the inner holder.

[0017] After adopting the design, the present application has at least the following advantages:

[0018] The outer holder of the heart valve replacement prosthesis of 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 outer holder is stably and reliably fixed inside the atrium and the movement of the prosthesis in the up-down direction is prevented. Meanwhile, the inner holder fixing section of the outer holder is arranged to extend to the position of the mitral valve annulus, so that the prosthesis cannot move in the left-right direction. In addition, the asymmetric arrangement of the D-shaped inner holder fixing section of the outer holder and the asymmetric shrink transition ring can make the prosthesis have strong anti-rotation ability, and the structure of the outer holder perfectly solves the overall fixation problem of the prosthesis.

[0019] In addition, the outer holder has different width of the upper and lower holder rods, so that the lower holder rod is flexible and the upper holder rod is rigid, which can not only adapt to the periodic morphological changes of the mitral valve, but also have sufficient support force, so as to solve the problem of long-term, stable and effective fixation of the biological membrane to the position of the mitral valve annulus, and achieve perfect fixation inside the atrium without affecting the contraction and diastole of the atrium.

[0020] The fixation mode of the heart valve replacement prosthesis of the present application is safe and reliable, does not damage any tissue structure, overcomes the problems that the barbs and hooks can cause electrical signal disorder, the hoop can cause tendon rupture, the tether can cause outflow tract obstruction, and the presence of the apex pad can cause the risk of heart apex bleeding. The heart valve replacement prosthesis of the present application can be operated by the way of transfemoral vein + crossing the interatrial septum, or by the way of transapical, which is simple and easy to operate. Meanwhile, the heart valve replacement prosthesis is easy to be received and transported during the operation. The heart valve replacement prosthesis of the present application is easy to be processed and formed, and can realize stable mass production. BRIEF DESCRIPTION OF DRAWINGS

[0021] The above is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0022] Figure 1 This is a schematic front view of the structure of the heart valve replacement prosthesis of the present invention.

[0023] Figure 2 This is a schematic front view of the external stent structure of the heart valve replacement prosthesis of the present invention.

[0024] Figure 3 This is a side view schematic diagram of the external stent structure of the heart valve replacement prosthesis of the present invention.

[0025] Figure 4 This is a top view schematic diagram of the external stent structure of the heart valve replacement prosthesis of the present invention.

[0026] Figure 5 This is a three-dimensional structural diagram of the external stent of the heart valve replacement prosthesis of the present invention. Detailed Implementation

[0027] This invention, through research on existing product fixation methods, identifies the core issue of valve replacement prostheses as: how to securely, stably, and undisturbedly fix the biomembrane to the valve annulus without affecting the heart's systolic and diastolic movements. Based on this, this invention creatively proposes a three-ring fixed mitral valve replacement prosthesis structure. Specific embodiments are as follows.

[0028] This embodiment uses a mitral valve replacement prosthesis as an example to describe the technical solution of the present invention in detail. It should not be construed as any limitation on this application. For example, this application can also be used for tricuspid valve replacement prostheses, active valve prostheses, etc.

[0029] See attached document Figure 1 As shown, the mitral valve replacement prosthesis in this embodiment includes an outer stent 1 and an inner stent 2. The inner stent 2 is disposed inside the outer stent 1, and the bottom of the outer stent 1 is fixedly connected to the bottom of the inner stent 2.

[0030] See attached document Figures 2 to 5 As shown, the external stent 1 in this embodiment includes, from top to bottom, an upper top ring 11, a hemispherical ring frame 12, a contraction transition ring 13, and an internal stent fixing section 14. The hemispherical ring frame 12 in this embodiment is a hemispherical support frame used to support the inner wall of the left atrium. Its hemispherical shape is similar to a hemisphere, and can be ellipsoidal or transhemispherical, etc. This hemispherical ring frame 12 mainly matches the internal shape of the left atrium, providing support to the inner wall of the left atrium in six directions: vertically, horizontally, and anteriorly / posteriorly, to ensure that the position of the mitral valve replacement prosthesis does not shift or rotate during cardiac motion.

[0031] In order to make it simple and convenient, the semi-sphere ring frame 12 forms a support for the atrium in at least two directions, in order to balance the production and support effect. The semi-sphere ring frame 12 supports the left atrium, forming the middle support ring in the three-ring fixed outer support.

[0032] The upper top ring 11 is a ring-shaped ring formed by connecting each vertex of the semi-sphere support frame in sequence, which is used to abut against the top of the left atrium. The flexible material of the upper top ring 11 is a high molecular polymer material, preferably polyethylene, ultra-high molecular weight polyethylene, polytetrafluoroethylene, polyester fiber, etc. The upper top ring 11 can be a single strand, 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 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, which is the upper support ring in the three-ring fixed outer support.

[0033] The contraction transition ring 13 is a smooth transition curved surface formed by the bottom of the semi-sphere support frame inwardly and smoothly contracting, which is used to adapt to the shape of the atrial wall near the annulus. The smooth transition curved surface of the contraction transition ring 13 includes a main valve support curved surface 131 near the aortic side and a heart ear support curved surface 132 opposite to the main valve support curved surface 131. The main valve support curved surface 131 is located near the aorta during surgical installation, which can match the shape of the left atrium near the aortic valve and can not press the aortic valve during the contraction and relaxation movement of the heart. The heart ear support curved surface 132 is located near the left atrial appendage during surgical installation, which matches the shape of the left atrium.

[0034] Specifically, in order to better adapt to the lower anatomical structure of the left atrium near the annulus, the curved surface angles of the main valve support curved surface 131 and the heart ear support curved surface 132 are different. For example, the curved surface angle of the main valve support curved surface 131 is 40-80 degrees, and the curved surface angle of the heart ear 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 heart ear support curved surface 132, which further improves the adaptability of the outer support to the lower part of the left atrium.

[0035] In this way, the main valve support curved surface 131 and the heart ear 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 shape 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, which is the lower support ring in the three-ring fixed outer support.

[0036] The inner stent fixed segment 14 is a cylindrical structure extending downward from the bottom of the shrinkage transition ring 13, which is used to adapt to the shape of the mitral annulus. In this embodiment, the cross section of the inner stent fixed segment 14 adopts a D-shaped structure matching the anatomical shape of the mitral annulus, as shown in the accompanying drawings. This D-shaped structure can fully adapt to the shape of the mitral annulus of all patients, preventing the occurrence of paravalvular leakage due to shape mismatch. And according to the different ages, genders, races, and disease types of patients, multiple specifications of D-shaped structures can be set. Figure 4

[0037] In order to adapt to the fact that the mitral annulus belongs to a saddle-shaped structure, the cylindrical structure of the inner stent fixed segment 14 needs to have a certain height. In this embodiment, the height h of the inner stent fixed segment 14 should be controlled between 5-25mm, so as to achieve the occlusion of the mitral valve and ensure that there is no problem of paravalvular leakage.

[0038] In this embodiment, the inner stent 2 is used to connect a biological membrane, which can be bovine pericardium, porcine pericardium or porcine aortic valve. The inner stent 2 can adopt any other frame structure of the inner stent in the existing valve replacement prosthesis.

[0039] In this embodiment, the bottom of the inner stent fixed segment 14 is provided with a fixing mechanism 141 connected with the inner stent 2. The fixing mechanism 141 is an expansion foot member passing through the hole 21 of the lower connecting column of the inner stent 2 from the bottom of the inner stent fixed segment 14, which is stable and reliable and easy to operate.

[0040] In this embodiment, the hemispherical ring frame 12, the shrinkage transition ring 13 and the inner stent fixed segment 14 are integrally processed and formed by using a memory alloy such as nickel-titanium alloy or nickel-titanium alloy. Specifically, it is made by laser cutting a nickel-titanium alloy pipe or a nickel-titanium alloy pipe and then shaping by heat treatment. Among them, according to the patient's anatomical data, the height of the hemispherical ring frame 12 and the shrinkage transition ring 13 should be 40-80mm, and the height of the inner stent fixed segment should be 5-25mm.

[0041] The basic thickness of the stent rod of the hemispherical ring frame 12, the shrinkage transition ring 13 and the inner stent fixed segment 14 is the wall thickness of the cut pipe, which is specifically 0.3-0.7mm. The width of the stent rod of the hemispherical ring frame 12 and the shrinkage transition ring 13 is 0.5-1.5mm, and the width of the stent rod of the inner stent fixed segment 14 is 0.3-0.7mm. In this way, since the width of the stent rod of the inner stent fixed segment 14 is narrower, it forms a softer part than the hemispherical ring frame 12 and the shrinkage transition ring 13, that is, it achieves the technical effect of being soft below and rigid above, which can better adapt to the systolic and diastolic movement of the left atrium.

[0042] ​The heart valve replacement prosthesis of the present application is fixed inside the left atrium by using three support rings, i.e., an upper ring, a middle ring and a lower ring, so that the prosthesis will not move in the up-down direction. Specifically, an upper ring is arranged at the top of the prosthesis to ensure that it touches the top of the left atrium, a ball-shaped ring frame is arranged in the middle to support the left atrium in all directions, and a petal transition form is arranged in front of and behind the lower ring, which is symmetric in front and asymmetric in left and right directions, 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 and right directions. More importantly, the asymmetric arrangement of the D-shaped inner support fixing section of the outer support and the asymmetric contraction 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.

[0043] The heart valve replacement prosthesis of the present application also forms a very important motion isolation effect through the cooperation of the outer support and the inner support. The long-term, stable and effective fixation of the biological membrane to the position of the mitral annulus is also solved by the lower flexible and upper rigid setting characteristics of the outer support. The person skilled in the art knows that the support structure of the replacement prosthesis in the left atrium must have sufficient support, and if it is too hard, it will affect the contraction and diastole of the left atrium, and if it is too soft, it will cause the prosthesis to shift, and even cause the prosthesis to periodically fluctuate up and down, thereby causing serious paravalvular leakage. Therefore, the D-shaped fixing section of the outer support of the present application has a narrow support rod width and belongs to a soft structure, which can adapt to the periodic morphological changes of the mitral valve. The semi-spherical ring frame and the contraction transition ring in the upper part have a wide support rod width and belong to a rigid structure, which can ensure sufficient support and cannot damage the left atrium. Therefore, the heart valve replacement prosthesis of the present application can achieve perfect fixation inside the atrium without affecting the contraction and diastole movement of the atrium.

[0044] In the description of the present application, it should be pointed out that the positions or positional relationships indicated by the terms "upper", "lower", "front", "rear", "left", "right" and the like are based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as limiting the devices or elements indicated to have a specific position, to be constructed and operated in a specific position, and therefore cannot be understood as limiting the present application.

[0045] In the description of the present application, it should be pointed out 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 it can be integrally connected, it can be directly connected, or it can be indirectly connected through an intermediate medium, or 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.

[0046] The above description is only the preferred embodiment of the present application, and is not intended to limit the present application in any form. Any simple modification, equivalent change or modification made by those skilled in the art based on the disclosed technical contents falls within the protection scope of the present application.

Claims

1. An outer frame of a heart valve replacement prosthesis, characterized in that, The outer stent comprises an upper top ring, a hemispherical ring support, a contraction transition ring and an inner stent fixing section arranged from top to bottom, the hemispherical ring support 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; The inner stent fixing section is a cylindrical structure extending 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; The smooth transition curved surface of the contraction 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 angles of the main valve support curved surface and the auricle support curved surface are different, the curved surface included angle of the main valve support curved surface is 40-80 degrees, and the curved surface included angle of the auricle support curved surface is 5-30 degrees; The hemispherical ring support, the contraction transition ring and the inner stent fixing section are integrally processed and formed by using nickel-titanium alloy or nickel-titanium alloy, the basic thickness of the stent rods of the hemispherical ring support, the contraction transition ring and the inner stent fixing section is 0.3-0.7 mm, the width of the stent rods of the hemispherical ring support and the contraction transition ring is 0.5-1.5 mm, the width of the stent rods of the inner stent fixing section is 0.3-0.7 mm, and the width of the stent rods of the inner stent fixing section is smaller than the width of the stent rods of the hemispherical ring support and the contraction transition ring, forming a structure of lower flexibility and upper rigidity.

2. The outer frame of a heart valve replacement prosthesis according to claim 1, characterized in that The hemispherical support frame forms support for the front and rear inner walls of the atrium in at least two directions.

3. The outer frame of a heart valve replacement prosthesis according to claim 1, characterized in that The flexible material of the upper top ring adopts high molecular polymer material.

4. The outer frame of a heart valve replacement prosthesis of claim 1, characterized in that The cross section of the inner stent fixing section adopts a D-shaped structure matching the annulus anatomical shape.

5. The outer frame of a heart valve replacement prosthesis of claim 1, characterized in that The height of the hemispherical ring support and the contraction transition ring is 40-80 mm, and the height of the inner stent fixing section is 5-25 mm.

6. The outer frame of a heart valve replacement prosthesis of claim 1, characterized in that The fixing mechanism is an expansion foot member passing through the hole of the inner stent from the bottom of the inner stent fixing section.

7. A heart valve replacement prosthesis, characterized in that, The outer stent of the heart valve replacement prosthesis of any one of claims 1 to 6, and the inner stent for fixing the biological membrane, the inner stent is arranged inside the outer stent, and the bottom of the inner stent fixing section of the outer stent is fixedly connected with the bottom hole of the inner stent.

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