A heart valve replacement prosthesis and its stent

Abstract

The present invention discloses a heart valve replacement prosthesis and a stent thereof, belonging to the field of heart valve replacement. The stent comprises a main beam suture frame connected end to end in a sinusoidal wave pattern, an upper hook arranged in the peak of the sinusoidal wave, and a lower hook arranged in the trough of the sinusoidal wave, wherein the hooking directions of the upper hook and the lower hook are opposite. A lower support frame and an upper support frame are also provided in the peak and trough of the sinusoidal wave. The present invention forms a cylindrical basic frame by setting a main beam suture frame connected end to end in a sinusoidal wave pattern, and by setting the upper and lower hooks with opposite hooking directions, it can directly act on the aortic valve or pulmonary valve with calcified lesions, and can also be fixed in the stent of the original heart valve replacement prosthesis when not used for the first time, completing the secondary replacement of the heart valve, solving the problem that the existing heart valve cannot be repaired after the first replacement, and greatly extending the life of the heart valve replacement prosthesis. The stent has strong rigidity, good shape retention and high yield.

Description

Technical Field

[0001] The present invention relates to the field of heart valve replacement, and in particular to a heart valve replacement prosthesis and a stent thereof. Background Art

[0002] Valvular heart disease refers to structural or functional abnormalities of the heart valves, which can affect one or more valves. Among valvular heart diseases in my country, the mitral valve is the most common, including mitral stenosis, mitral regurgitation, or a combination of mitral stenosis and regurgitation. The aortic valve is the second most common valvular heart disease. Among degenerative valvular diseases in the elderly, the aortic valve is the most common, including aortic stenosis, aortic regurgitation, or a combination of aortic stenosis and regurgitation. The mitral valve is the second most common valvular heart disease.

[0003] Heart valve replacement is a type of surgery performed on patients with valvular heart disease. Currently, the main methods include surgical valve replacement and interventional repair or replacement. Surgical valve replacement requires a thoracotomy. Under general anesthesia, a minimally invasive incision is made into the heart to remove the diseased valve. A healthy synthetic or metal valve is then sutured in its place. Interventional valve repair or replacement is a minimally invasive procedure that does not require a thoracotomy and is performed under the guidance of an internal medicine surgeon or a collaborative procedure between an internal medicine surgeon and a surgeon.

[0004] Both surgical and interventional valve prostheses face a lifespan issue: after many years of use, the prosthesis can no longer be used. Without a product that allows for a second surgery, the patient's life would be catastrophic, with only the end of life to await. The advent of valve-in-valve prostheses offers a glimmer of hope for patients, but current valve-in-valve prostheses are primarily intended for second surgeries following surgical valve replacement. For valve replacement following interventional procedures, no suitable valve-in-valve prosthesis has yet been developed.

[0005] Therefore, the existing heart valve replacement prostheses and stents mentioned above are still not suitable for non-first-time interventional heart valve replacement surgeries, and further improvement is urgently needed. The goal of creating a new heart valve replacement prosthesis and stent that can be used for both first-time heart valve replacement surgeries and non-first-time interventional heart valve repair or replacement surgeries has become a pressing need in the industry. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a heart valve replacement prosthesis stent, which can be used for both the first heart valve replacement surgery and non-first heart valve interventional repair or replacement surgery, thereby overcoming the shortcomings of existing heart valve replacement prostheses.

[0007] To solve the above technical problems, the present invention provides a heart valve replacement prosthesis stent, comprising a main beam suture frame connected end to end in a sinusoidal wave pattern, an upper hook arranged in the sinusoidal wave crest of the main beam suture frame, and a lower hook arranged in the sinusoidal wave trough of the main beam suture frame, wherein the hooking directions of the upper hook and the lower hook are opposite.

[0008] As a further improvement, the main beam stitching frame includes three sinusoidal wave peaks and three sinusoidal wave troughs.

[0009] As a further improvement, a lower support frame is further provided at the open end of the sinusoidal wave crest of the main beam suturing frame.

[0010] As a further improvement, the lower support frame adopts an X-shaped, U-shaped, diamond-shaped or double diamond-shaped structure.

[0011] As a further improvement, an upper support frame is further provided at the open end of the sine wave trough of the main beam suturing frame.

[0012] As a further improvement, the upper support frame adopts an X-shaped, U-shaped, diamond-shaped or double diamond-shaped structure.

[0013] As a further improvement, the heart valve replacement prosthesis stent is provided with a lower support frame and an upper support frame.

[0014] As a further improvement, the beam width of the main beam suturing frame is 0.8-2.0 mm, the width of the upper support frame is 0.2-2.0 mm, and the main beam suturing frame is provided with a plurality of suturing holes or suturing grooves.

[0015] As a further improvement, the heart valve replacement prosthesis stent is formed by laser cutting a nickel-titanium alloy tube and then heat treating it to shape it. The upper hook is arranged on the outside or inside of the main beam suture frame, and the lower hook is arranged on the inside or outside of the main beam suture frame.

[0016] As another improvement of the present invention, the present invention also provides a heart valve replacement prosthesis, including the above-mentioned heart valve replacement prosthesis stent.

[0017] As a further improvement, when it is not the first heart valve replacement surgery, the heart valve replacement prosthesis stent is fixed in the stent of the original heart valve replacement prosthesis by the upper hook and the lower hook in an interference fit manner, with the interference fit being 1-5 mm.

[0018] After adopting such a design, the present invention has at least the following advantages:

[0019] The heart valve replacement prosthesis stent of the present invention is arranged by a main beam suture frame connected end to end in a sinusoidal wave manner to form a cylindrical basic frame, and the upper hook and lower hook are arranged in opposite directions, so that it can directly act on the aortic valve or pulmonary valve with calcified lesions when used for the first time, and can also be fixed in the stent of the original heart valve replacement prosthesis by interference extrusion when not used for the first time, completing the secondary replacement of the heart valve, solving the problem that the existing heart valve cannot be repaired after the first replacement, and greatly extending the life of the heart valve replacement prosthesis.

[0020] The heart valve replacement prosthesis stent has strong rigidity, ensuring that the biological valve or artificial valve sutured with the stent is not affected by external loads, and the upper and lower hooks in different directions firmly fix the valve prosthesis or the naturally diseased valve, ensuring that the prosthesis does not move during the contraction and relaxation movement of the heart, can continue to work normally, and has a longer service life.

[0021] The provision of a reinforced support frame on the main beam suturing frame also helps to better maintain the shape, improve the yield rate, and ensure the success rate of the operation. At the same time, the provision of suturing holes or suturing grooves on the main beam suturing frame can better be used for suturing biological valves or artificial valves. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0023] Figure 1 This is a structural front view of the main beam suturing frame in the heart valve replacement prosthesis stent of the present invention.

[0024] Figure 2 It is a structural side view of the main beam suturing frame in the heart valve replacement prosthesis stent of the present invention.

[0025] Figure 3 It is a schematic diagram of the three-dimensional structure of the main beam suturing frame in the heart valve replacement prosthesis stent of the present invention.

[0026] Figure 4 It is a schematic diagram of the three-dimensional structure of Example 1 of the heart valve replacement prosthesis stent of the present invention.

[0027] Figure 5 This is a structural front view of Example 1 of the heart valve replacement prosthetic stent of the present invention.

[0028] Figure 6 It is a structural side view of Example 1 of the heart valve replacement prosthetic stent of the present invention.

[0029] Figure 7 It is a top view of the structure of the first embodiment of the heart valve replacement prosthetic stent of the present invention.

[0030] Figure 8 It is a schematic diagram of the manufacturing process of Example 1 of the heart valve replacement prosthetic stent of the present invention.

[0031] Figure 9 It is a schematic diagram of the three-dimensional structure of the heart valve replacement prosthesis stent after laser cutting in Example 1 of the present invention.

[0032] Figure 10 This is an expanded view of the three-dimensional structure of the heart valve replacement prosthesis stent in Example 1 of the present invention after laser cutting.

[0033] Figure 11 It is a schematic diagram of the three-dimensional structure of the second embodiment of the heart valve replacement prosthesis stent of the present invention.

[0034] Figure 12 It is a structural schematic diagram of Example 2 of the heart valve replacement prosthetic stent of the present invention.

[0035] Figure 13 This is a schematic diagram of the manufacturing process of the second embodiment of the heart valve replacement prosthetic stent of the present invention.

[0036] Figure 14 This is an expanded view of the three-dimensional structure of the heart valve replacement prosthesis stent after laser cutting in Example 2 of the present invention.

[0037] Figure 15 It is a schematic diagram of the three-dimensional structure of the third embodiment of the heart valve replacement prosthesis stent of the present invention.

[0038] Figure 16 This is a structural front view of Example 3 of the heart valve replacement prosthetic stent of the present invention.

[0039] Figure 17 It is a structural side view of Example 3 of the heart valve replacement prosthetic stent of the present invention.

[0040] Figure 18 This is an expanded view of the three-dimensional structure of the heart valve replacement prosthesis stent after laser cutting in Example 3 of the present invention.

[0041] Figure 19 It is a schematic diagram of the structure of the inner stent in the heart valve replacement prosthesis of existing manufacturers. DETAILED DESCRIPTION

[0042] The heart valve replacement prosthesis of the present invention pioneers the concept of a valve-in-valve prosthesis for mitral valve replacement. It is suitable for use in stent structures for surgical valve prostheses, particularly those similar to Abbott's Tendyne mitral valve prosthesis and similar structures. This solves the problem of existing heart valves being unable to be repaired after initial replacement, significantly extending the lifespan of heart valve replacement prostheses. Of course, this heart valve replacement prosthesis can also be used as a primary aortic valve replacement or pulmonary valve replacement prosthesis. Specific embodiments are as follows.

[0043] Example 1

[0044] The heart valve replacement prosthesis stent of this embodiment comprises a main beam suture frame 1 connected end to end in a sinusoidal wave pattern, an upper hook 2 positioned at the peak of the sine wave of the main beam suture frame 1, and a lower hook 3 positioned at the trough of the sine wave of the main beam suture frame 1. The upper hook 2 and the lower hook 3 are arranged in opposite directions. The main beam suture frame 1 thus forms a cylindrical frame structure that can be used directly on a calcified aortic valve or pulmonary valve during initial use. Alternatively, it can be fixed to a single-layer stent of an existing heart valve replacement prosthesis or to the inner stent of a double-layer stent of an existing heart valve replacement prosthesis through interference compression during secondary heart valve replacement or repair.

[0045] Refer to the attached Figures 1 to 3 As shown, the main beam sewing frame 1 in this embodiment includes three sinusoidal wave peaks 11 and three sinusoidal wave troughs 12. Of course, the main beam sewing frame 1 can also include more than three sinusoidal wave peaks and sinusoidal wave troughs according to actual conditions.

[0046] Refer to the attached Figures 4 to 7 As shown, the open ends of the sinusoidal wave crests 11 of the main beam suture frame 1 in this embodiment are further provided with X-shaped lower support frames 5. This enhances the rigidity of the main beam suture frame, helps maintain its shape, and provides excellent support. Furthermore, when each open end of the sinusoidal wave crest 11 is provided with an X-shaped lower support frame 5, its pulling action can be utilized to evenly divide the suture frame into three equal parts, ensuring that the overall structure maintains a relatively good cylindrical shape.

[0047] To further enhance rigidity, an upper support frame 4 is provided at the open end of the sine wave trough 12 of the main beam suture frame 1. This upper support frame 4 can employ the same X-shaped structure as the lower support frame 5, or a different structure, such as a U-shaped, diamond-shaped, or double-diamond-shaped structure. The rigidity of this main beam suture frame ensures that the bioprosthetic or artificial valve attached to it is unaffected by external loads. Furthermore, upper and lower hooks in different orientations firmly secure the valve prosthesis or naturally diseased valve, ensuring that the prosthesis remains in place during cardiac contraction and relaxation, enabling continued normal operation and extending its service life.

[0048] In this embodiment, the main beam suture frame 1 has the strongest beam rigidity, and its beam width is 0.8-2.0mm, preferably 1.2mm. The width of the upper support frame 4 and the lower support frame 5 is 0.2-2.0mm, preferably 0.5mm, which is thinner than the width of the main beam suture frame.

[0049] The main beam suturing frame 1 is provided with a plurality of suturing holes or suturing grooves for suturing with a biological valve or an artificial valve.

[0050] Refer to the attached Figures 8 to 10 As shown in FIG, the heart valve replacement prosthesis stent is formed by laser cutting nickel-titanium alloy tubes and then heat treating them to shape them. Figure 8 As shown, the nickel-titanium alloy tube is laser cut, radially stretched and heat-treated, and its upper and lower hooks are bent and polished to obtain the heart valve replacement prosthesis stent.

[0051] The upper hook 2 can be bent outside or inside the main beam sewing frame 1. Similarly, the lower hook 3 can be bent outside or inside the main beam sewing frame 1, as long as the bending direction of the upper hook 2 is different from that of the lower hook 3.

[0052] That is, the upper hook 2 and the lower hook 3 in this embodiment can have a variety of combinations, such as the upper hook 2 upward, on the outside of the main beam sewing frame 1 + the lower hook 3 downward, on the inside of the main beam sewing frame 1; the upper hook 2 upward, on the inside of the main beam sewing frame 1 + the lower hook 3 downward, on the outside of the main beam sewing frame 1; the upper hook 2 upward, on the outside of the main beam sewing frame 1 + the lower hook 3 downward, on the outside of the main beam sewing frame 1; the upper hook 2 upward, on the inside of the main beam sewing frame 1 + the lower hook 3 downward Downward, on the inner side of the main beam sewing frame 1; the upper hook 2 downward, on the outer side of the main beam sewing frame 1 + the lower hook 3 upward, on the inner side of the main beam sewing frame 1; the upper hook 2 downward, on the inner side of the main beam sewing frame 1 + the lower hook 3 upward, on the outer side of the main beam sewing frame 1; the upper hook 2 downward, on the outer side of the main beam sewing frame 1 + the lower hook 3 upward, on the outer side of the main beam sewing frame 1; the upper hook 2 downward, on the inner side of the main beam sewing frame 1 + the lower hook 3 upward, on the inner side of the main beam sewing frame 1.

[0053] The above-mentioned heart valve replacement prosthesis stent is used in Abbott's Tendyne mitral valve prosthesis, as shown in the attached Figure 19As shown, the upper hook 2 is fixed to the top A of the original inner stent, and the lower hook 3 is fixed to the middle B of the original inner stent, and the hard connection method of the upper and lower hooks + interference extrusion is used to achieve the fixation of the valve-in-valve prosthesis and the original valve frame. Among them, the interference amount cannot be too large or too small. If the interference amount is too small, the degree of combination between the stent and the original inner stent is insufficient, and displacement is inevitable during the long use process; if the interference amount is too large, it may cause the original valve frame to break or the diseased valve to tear, etc., leading to serious consequences. Therefore, the design preferred value of the interference amount should be between 1-5mm, preferably 2mm. Of course, the heart valve replacement prosthesis stent can also be fixed to other original valve frames, such as surgical valve stents or tendyne-like inner stent structures in interventional valves.

[0054] When the above-mentioned heart valve replacement prosthesis stent is used for the first replacement surgery, the upper and lower hooks of the stent no longer play the role of hanging the original stent structure, but serve as outward support to support the upper and lower sides of the valve, thereby preventing the prosthesis from moving.

[0055] The heart valve replacement prosthesis stent of the present invention is arranged by a main beam suture frame connected end to end in a sinusoidal wave manner to form a cylindrical basic frame, and the upper hook and lower hook are arranged in opposite directions, so that it can directly act on the aortic valve or pulmonary valve with calcified lesions when used for the first time, and can also be fixed in the inner stent of the original heart valve replacement prosthesis by interference extrusion when used for non-first time, such as second, third, or even fourth or more operations, to complete heart valve replacement or repair, completely solving the problem that the existing heart valve cannot be repaired after the first replacement, and greatly extending the life of the heart valve replacement prosthesis.

[0056] Example 2

[0057] The difference between this embodiment and the above embodiment 1 is that the shapes of the upper support frame 4 and the lower support frame 5 are different. Figures 11 to 14 As shown, in this embodiment, the lower support frame 5 and the upper support frame 4 both adopt a U-shaped structure. Of course, the upper support frame 4 can also adopt an X-shaped, diamond-shaped or double diamond-shaped structure.

[0058] The other structures and manufacturing methods are the same as those in the above embodiment and will not be described again here.

[0059] Example 3

[0060] The difference between this embodiment and the above embodiment 1 is that the shapes of the upper support frame 4 and the lower support frame 5 are different. Figures 15 to 18 As shown, in this embodiment, the lower support frame 5 and the upper support frame 4 both adopt a double diamond structure. Of course, the upper support frame 4 can also adopt an X-shaped, U-shaped or diamond-shaped structure.

[0061] The other structures and manufacturing methods are the same as those in the above embodiment and will not be described again here.

[0062] In the description of the present invention, it should be noted that the terms "upper", "lower", "front", "back", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limiting the present invention.

[0063] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0064] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Those skilled in the art can make some simple modifications, equivalent changes or modifications based on the technical content disclosed above, which all fall within the scope of protection of the present invention.

Claims

1. A heart valve replacement prosthesis stent, characterized in that: It includes a main beam suturing frame connected end to end in a sinusoidal wave pattern, an upper hook disposed in the crest of the sinusoidal wave of the main beam suturing frame, and a lower hook disposed in the trough of the sinusoidal wave of the main beam suturing frame, wherein the upper hook and the lower hook have opposite hooking directions and are used to firmly fix the valve prosthesis or the naturally diseased valve; The main beam stitching frame only includes three sinusoidal wave peaks and three sinusoidal wave troughs; A lower support frame is further provided at the open end of the sinusoidal wave crest of the main beam sewing frame, and an upper support frame is further provided at the open end of the sinusoidal wave trough of the main beam sewing frame.

2. The heart valve replacement prosthesis stent according to claim 1, characterized in that: The lower support frame adopts an X-shaped, U-shaped, diamond-shaped or double diamond-shaped structure.

3. The heart valve replacement prosthesis stent according to claim 1, characterized in that: The upper support frame adopts an X-shaped, U-shaped, diamond-shaped or double diamond-shaped structure.

4. The heart valve replacement prosthesis stent according to claim 1, characterized in that: The beam width of the main beam suturing frame is 0.8-2.0 mm, the width of the upper support frame is 0.2-2.0 mm, and the main beam suturing frame is provided with a plurality of suturing holes or suturing grooves.

5. The heart valve replacement prosthesis stent according to claim 1, characterized in that: The heart valve replacement prosthesis stent is formed by laser cutting a nickel-titanium alloy tube and then heat treating it to shape it. The upper hook is arranged on the outside or inside of the main beam suture frame, and the lower hook is arranged on the inside or outside of the main beam suture frame.

6. A heart valve replacement prosthesis, characterized in that: A heart valve replacement prosthetic stent comprising the heart valve replacement prosthesis according to any one of claims 1 to 5.

7. The heart valve replacement prosthesis according to claim 6, characterized in that: In a non-first heart valve replacement surgery, the heart valve replacement prosthesis stent is fixed in the stent of the original heart valve replacement prosthesis by means of the upper hook and the lower hook in an interference fit manner, with the interference fit being 1-5 mm.

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