A percutaneously implanted artificial aortic valve that prevents paravalvular leak

Abstract

In the embodiment of the present application, a percutaneously implanted artificial aortic valve that can prevent paravalvular leakage is provided, which relates to the field of medical devices; a valve stent and an artificial valve placed in the valve stent, the valve stent is woven by metal wire to form a double trumpet-shaped mesh structure, the valve stent includes a large trumpet part at the proximal end, a middle waist part and a small trumpet part at the distal end, the large trumpet part at the proximal end faces the end where blood flows out, and the small trumpet part at the distal end faces the end where blood flows in; the outer wall of the metal wire corresponding to the middle waist part is provided with a rough structure, and the rough structure is opposite to the inner membrane of the outflow tract; the opposite side wall of the metal wire corresponding to the middle waist part is provided with a plurality of grooves, and the grooves correspond to the circumference of the valve stent, wherein the grooves are filled with expansion materials, and the expansion materials will expand after contacting with blood. The present application can increase the friction of the middle waist part, and prevent paravalvular leakage by stimulating intimal hyperplasia; it can automatically fill the paravalvular leakage gap and reduce the occurrence of paravalvular leakage.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage. Background Art

[0002] Aortic valve stenosis is a disease that many people may suffer from in today's society, especially in the middle-aged and elderly population, and the incidence of aortic valve stenosis is increasing. Initially, the treatment of aortic valve disease mainly relied on conservative drug treatment, but the treatment effect was not good.

[0003] For severe aortic stenosis, we will first consider surgical aortic valve replacement (SAVR). For the elderly and those with high surgical risk, open-heart surgery may be difficult to perform. In this case, we will consider transcatheter aortic valve implantation (TAVI). TAVI is a minimally invasive treatment in which a prosthetic valve is placed in the heart using a catheter. A long, thin catheter is used to place the prosthetic valve into the patient's aortic valve.

[0004] In the prior art, medical devices using this method mainly include a valve stent and an artificial valve arranged in the valve stent. When the valve stent is placed in the aorta, it needs to use its own expansion to abut against the tissue of the aorta, so that the valve stent is fixed.

[0005] The valve stent itself is a grid-like structure, which only relies on its side to abut against the aortic tissue to achieve its sealing. The sealing effect is relatively poor, and there is a risk of paravalvular leakage; paravalvular leakage refers to the residual leakage between the artificial valve ring and the patient's valve ring after valve replacement surgery, which will pose a major hidden danger to the patient's health. During implantation, the expansion of the valve stent itself is matched with the position of the diseased valve ring as much as possible. Although it can reduce paravalvular leakage to a certain extent, due to the irregular shape of the patient's blood vessel wall after autologous calcification, and due to heart failure, the valve ring expands, the valve stent and the valve ring cannot match well, resulting in an increase in the gap, and varying degrees of paravalvular leakage and peripheral regurgitation will still occur. Summary of the invention

[0006] In view of the above problems, embodiments of the present invention are proposed to provide a percutaneously implanted artificial aortic valve that can prevent paravalvular leakage and overcome the above problems or at least partially solve the above problems.

[0007] A percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage comprises a valve stent, wherein the valve stent is woven from metal wires to form a double trumpet-shaped mesh structure, the valve stent comprises a large trumpet portion at the proximal end, a middle waist portion and a small trumpet portion at the distal end, the large trumpet portion at the proximal end faces an end where blood flows out, and the small trumpet portion at the distal end faces an end where blood flows in; the outer side wall of the metal wire corresponding to the middle waist portion is provided with a rough structure, wherein the rough structure is opposite to the inner membrane of the outflow tract; the opposite side wall of the metal wire corresponding to the middle waist portion is provided with a plurality of grooves, wherein the grooves correspond to the circumferential direction of the valve stent, and the plurality of grooves are spaced apart along the length direction of the metal wire, wherein the grooves are filled with expansion material, and the expansion material expands after contacting with blood.

[0008] Preferably, the rough structure is a plurality of protrusions provided on the metal wire or a plurality of grooves opened on the metal wire.

[0009] Preferably, the expansion material is a biocompatible high molecular polymer.

[0010] Preferably, the diameter of the metal wire is 0.2 mm-0.6 mm.

[0011] Preferably, the depth of the groove cavity is smaller than the depth of the groove, and the depth of the groove is 0.05mm-0.3mm.

[0012] Preferably, the length of the groove cavity is smaller than the length of the groove.

[0013] Preferably, the length of the groove cavity is 0.1 mm-2.0 mm, and the length of the groove is 1.0 mm-3.0 mm.

[0014] Preferably, the cavity and the groove are engraved on the metal wire by laser.

[0015] Preferably, a plurality of anchors are provided at one end of the proximal large horn portion away from the distal small horn portion, and the plurality of anchors are connected to the ends of the plurality of metal wires uniformly or unevenly in the circumferential direction.

[0016] Preferably, it also includes a skirt, which is covered on the small trumpet portion at the distal end, and the skirt is annular and extends toward the end where blood flows in, and the outer side wall of the skirt is used for abutting and sealing with the leaflets of the aortic valve.

[0017] The present application specifically includes the following advantages:

[0018] In an embodiment of the present application, a valve stent is woven from metal wires to form a double-trumpet-shaped mesh structure, and the valve stent includes a large trumpet portion at the proximal end, a middle waist portion, and a small trumpet portion at the distal end, the large trumpet portion at the proximal end faces the blood outflow end, and the small trumpet portion at the distal end faces the blood inflow end; the outer side wall of the metal wire corresponding to the middle waist portion is provided with a rough structure, and the rough structure is opposite to the inner membrane of the outflow tract; the opposite side wall of the metal wire corresponding to the middle waist portion is provided with a plurality of grooves, and the grooves correspond to the circumferential direction of the valve stent, and the plurality of grooves are spaced apart along the length direction of the metal wire, wherein the grooves are filled with expansion material, and the expansion material will expand after contacting with blood. By providing a rough structure on the outer wall of the metal wire at the waist position corresponding to the valve ring, the rough structure is opposite to the inner membrane of the outflow tract, so that the side wall of the metal wire forms a rough wall surface, increasing the friction between the metal wire and the inner wall of the aorta, thereby stimulating the hyperplasia of the inner membrane of the aorta, narrowing the gap, and reducing or preventing paravalvular leakage; by providing a plurality of grooves on the opposite side walls of the metal wire corresponding to the middle waist, the grooves are located in the circumferential direction of the valve stent, and the grooves are filled with expansion materials. After the expansion materials come into contact with blood, they absorb the moisture in the blood and expand, which can fill the gap between the valve ring and the metal wire, thereby further reducing the paravalvular leakage, and will not affect the fixation of the stent. The present application can increase the friction of the middle waist, prevent paravalvular leakage by stimulating the hyperplasia of the inner membrane; and can automatically fill the paravalvular leakage gap to reduce the occurrence of paravalvular leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solution of the present application, the drawings required for use in the description of the present application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0020] Figure 1 It is a schematic structural diagram of a percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage provided by an embodiment of the present invention;

[0021] Figure 2 The present invention Figure 1 A schematic diagram of the structure enlargement in the middle;

[0022] Figure 3 is a longitudinal cross-sectional view of a metal wire provided by an embodiment of the present invention;

[0023] Figure numerals: 100, metal wire; 200, large trumpet at the proximal end; 210, anchor; 300, middle waist; 310, rough structure; 311, groove; 320, groove; 321, expansion material; 400, small trumpet at the distal end; 500, artificial valve; 600, skirt. DETAILED DESCRIPTION

[0024] In order to make the objects, features and advantages of the present application more obvious and understandable, the present application is further described in detail below in conjunction with the accompanying drawings and specific implementation methods. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0025] Reference Figure 1-3 , showing a schematic structural diagram of a percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage of the present invention, which may specifically include the following structures: a valve stent, wherein the valve stent is woven by metal wires 100 to form a double trumpet-shaped mesh structure, wherein the valve stent includes a large trumpet portion 200 at the proximal end, a middle waist portion 300 and a small trumpet portion 400 at the distal end, wherein the large trumpet portion 200 at the proximal end faces the blood outflow end, and the small trumpet portion 400 at the distal end faces the blood inflow end; a rough structure 310 is provided on the outer side wall of the metal wire 100 corresponding to the middle waist portion 300, wherein the rough structure 310 is opposite to the inner membrane of the outflow tract; a plurality of grooves 320 are provided on the opposite side walls of the metal wire 100 corresponding to the middle waist portion 300, wherein the grooves 320 correspond to the circumferential direction of the valve stent, wherein the grooves 320 are filled with expansion material 321, and the expansion material 321 expands after contacting with blood.

[0026] In an embodiment of the present application, through a valve stent and an artificial valve placed in the valve stent, the valve stent is woven by a metal wire 100 to form a double trumpet-shaped mesh structure, and the valve stent includes a large trumpet portion 200 at the proximal end, a middle waist portion 300 and a small trumpet portion 400 at the distal end, the large trumpet portion 200 at the proximal end faces the blood outflow end, and the small trumpet portion 400 at the distal end faces the blood inflow end; the outer side wall of the metal wire 100 corresponding to the middle waist portion 300 is provided with a rough structure 310, and the rough structure 310 is opposite to the inner membrane of the outflow tract; the opposite side wall of the metal wire 100 corresponding to the middle waist portion 300 is provided with a plurality of grooves 320, and the grooves 320 correspond to the circumferential direction of the valve stent, wherein the grooves 310 are filled with expansion material 321, and the expansion material 321 will expand after contacting with blood. By setting a rough structure 310 on the outer wall of the metal wire 100 at the waist position corresponding to the valve ring, the rough structure 310 is opposite to the intima of the outflow tract, so that the side wall of the metal wire 100 forms an uneven rough wall surface, which increases the friction between the metal wire 100 and the inner wall of the aorta, thereby stimulating the intimal hyperplasia of the inner wall of the aorta, narrowing the gap, and reducing or preventing paravalvular leakage; by opening a plurality of grooves 320 on the opposite side wall of the metal wire 100 corresponding to the middle waist 300, the grooves 320 are located in the circumferential direction of the valve stent, and the grooves 310 are filled with expansion material 321. After the expansion material 321 contacts the blood, it absorbs the water in the blood and expands, which can fill the gap between the valve ring and the metal wire 100, thereby further reducing the paravalvular leakage phenomenon, and will not affect the fixation of the stent. The present application can increase the friction of the middle waist 300, prevent paravalvular leakage by stimulating intimal hyperplasia, and can automatically fill the paravalvular leakage gap to reduce the occurrence of paravalvular leakage.

[0027] Next, a percutaneously implanted artificial aortic valve that can prevent paravalvular leakage in this exemplary embodiment will be further described.

[0028] In an embodiment of the present application, an artificial valve is disposed in a valve stent. Specifically, the artificial valve is sewn on the cross-section of the valve stent and divides the valve stent into two areas, one of which is toward the blood outflow end of the aortic valve, that is, connected to the aortic cavity; the other area is toward the blood inflow end of the aortic valve, that is, connected to the left ventricle.

[0029] The valve stent is in a double trumpet shape, and the valve stent is woven by metal wire 100 to form a diamond mesh structure, and the valve stent includes a large trumpet part 200 at the proximal end, a middle waist part 300 and a small trumpet part 400 at the distal end, wherein the diameter of the large trumpet part 200 at the proximal end is 25 mm, the diameter of the middle waist part 300 is 22 mm, the waist length is 14 mm, and the diameter of the small trumpet part 400 at the distal end is 24 mm. A rough structure 310 is provided on the outer wall of the metal wire 100 corresponding to the middle waist part 300, and the rough structure 310 is opposite to the intima of the outflow tract, wherein the middle waist part 300 corresponds to the position of the valve ring. By setting the outer wall of the metal wire 100 of the middle waist part 300 as the rough structure 310, a rough surface is formed, and the friction between the rough surface and the inner wall of the aorta is increased, thereby stimulating intimal hyperplasia, reducing the gap between the metal wire 100 and the valve ring, and reducing paravalvular leakage. The manufacturing material of the valve stent is preferably nickel-titanium alloy, which is a shape memory alloy that can shrink and expand to restore its shape. It also has good wear resistance, corrosion resistance, etc., and can effectively achieve overall shrinkage and expansion.

[0030] As an example, the rough structure 310 is a plurality of protrusions provided on the metal wire 100 or a plurality of grooves 311 opened on the metal wire 100, so that the outer wall of the metal wire forms an uneven rough surface.

[0031] In a specific embodiment, it is preferably configured as a plurality of closely arranged groove cavities 311 , which will not increase the volume of the stent, will not cause damage to the endothelium, and can also form an uneven rough surface on the side wall of the stent.

[0032] In an embodiment of the present application, a plurality of grooves 320 are provided on the opposite side walls of the metal wire 100 corresponding to the middle waist 300, and the grooves 320 correspond to the circumferential direction of the valve stent, wherein the grooves 320 are filled with expansion material 321, and the expansion material 321 expands upon contact with blood.

[0033] By providing a groove 320 and providing an expandable material 321 in the groove 320 that can expand after contacting with blood, the gap between the valve ring and the metal wire 100 is filled by slowly absorbing moisture in the blood and expanding, thereby further reducing paravalvular leakage. The structure provided with the groove 320 will not increase the volume of the stent, and by being provided on both sides of the metal wire 100, it is not opposite to the inner membrane, so it will not affect the fixation of the stent.

[0034] Specifically, the expansion material 321 is a biocompatible high molecular polymer. Biocompatibility means that the material and the blood can adapt to each other without other rejection reactions, thereby not causing other damage to the patient. The expansion material 321 expands after contacting the blood, thereby filling the gap between the valve ring and the metal wire 100 while ensuring safety, thereby effectively preventing paravalvular leakage.

[0035] As an example, the diameter of the metal wire 100 is 0.2mm-0.6mm, the depth of the groove 311 is less than the depth of the groove 320, and the depth of the groove is 0.05mm-0.3mm. Since the groove 311 only serves to increase the roughness, its depth is shallow and will not affect the strength of the stent to avoid breaking. Since the groove 320 needs to accommodate a certain amount of expansion material, its depth can be deeper than the groove 311. In addition, the depths of the groove 311 and the groove 320 must be less than or equal to the radius of the metal wire 100 to avoid the metal wire 100 at the middle waist 300 being insufficiently strong and easily deformed or broken.

[0036] As an example, the length of the groove cavity 311 is smaller than the length of the groove 320 , the length of the groove cavity 311 is 0.1 mm-2.0 mm, and the length of the groove is 1.0 mm-3.0 mm.

[0037] In a specific embodiment, the diameter of the metal wire 100 is 0.2 mm, the depth of the groove cavity 311 is 0.15 mm, the depth of the groove 320 is 0.1 mm, the length of the groove cavity 311 is 0.15 mm, and the length of the groove 320 is 1 mm.

[0038] As an example, the groove cavity 311 and the groove 320 are laser engraved on the metal wire 100. Since the diameter of the metal wire 100 is small, laser engraving is used to make grooves on the metal wire 100 for easy operation.

[0039] As an example, a plurality of anchors 210 are provided at one end of the proximal large trumpet 200 away from the distal small trumpet 400, and the plurality of anchors 210 are connected to the ends of the plurality of metal wires 100 uniformly or unevenly in the circumferential direction. The anchors 210 increase the contact area between the support part and the inner wall of the aorta to enhance fixation on the one hand; on the other hand, they can be connected to a delivery device, and the hook at the front end of the delivery device passes through the anchor 210 to push the valve stent forward and push it into the blood vessel for release; they can also be recovered, and a safety rope is passed through the anchor 210, and the safety rope is recovered after confirming that the release position is correct. If the release position is incorrect and needs to be adjusted, the safety rope can be recovered to pull the valve stent back into the sheath.

[0040] As an example, a skirt is also included, and the skirt is covered on the distal end small trumpet part 400, and the skirt is annular and extends toward the end where blood flows in, and the outer wall of the skirt is used to abut and seal with the leaflets of the aortic valve. The manufacturing material of the skirt is polyethylene terephthalate or polytetrafluoroethylene or bovine pericardium or porcine pericardium. Through the above technical scheme, polyethylene terephthalate has good physical and mechanical properties, and its creep resistance, fatigue resistance, friction resistance and dimensional stability are very good. Polytetrafluoroethylene has an extremely low friction coefficient, and is chemically stable, corrosion-resistant, and has strong sealing properties. Both bovine pericardium and porcine pericardium have good biocompatibility, low antigenicity, and are not prone to rejection reactions. Therefore, they can be used to manufacture structures such as skirts that are in direct contact with human tissues.

[0041] Although the preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the embodiments of the present invention.

[0042] Finally, it should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or terminal device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or terminal device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or terminal device including the elements.

[0043] The above is a detailed introduction to the percutaneously implanted artificial aortic valve for preventing paravalvular leakage provided by the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. At the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present invention.

Claims

1. A percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage, comprising a valve stent, wherein the valve stent is woven from metal wires to form a double trumpet-shaped mesh structure, characterized in that: The valve stent includes a large trumpet portion at the proximal end, a middle waist portion and a small trumpet portion at the distal end, wherein the large trumpet portion at the proximal end faces the blood outflow end, and the small trumpet portion at the distal end faces the blood inflow end; the outer side wall of the metal wire corresponding to the middle waist portion is provided with a rough structure, and the rough structure is opposite to the inner membrane of the outflow tract; the opposite side wall of the metal wire corresponding to the middle waist portion is provided with a plurality of grooves, and the grooves correspond to the circumferential direction of the valve stent, and the plurality of grooves are arranged at intervals along the length direction of the metal wire, wherein the grooves are filled with expansion material, and the expansion material will expand after contacting with blood; the rough structure is a plurality of protrusions provided on the metal wire or a plurality of groove cavities opened on the metal wire.

2. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 1, characterized in that: The expansion material is a biocompatible high molecular polymer.

3. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 1, characterized in that: The diameter of the metal wire is 0.2 mm-0.6 mm.

4. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 3, characterized in that: The depth of the groove cavity is smaller than the depth of the groove, and the depth of the groove is 0.05mm-0.3mm.

5. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 3, characterized in that: The length of the groove cavity is smaller than the length of the groove.

6. The percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage according to claim 5, characterized in that: The length of the groove cavity is 0.1mm-2.0mm, and the length of the groove is 1.0mm-3.0mm.

7. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 1, characterized in that: The groove cavity and the groove are engraved on the metal wire by laser.

8. The percutaneously implanted artificial aortic valve capable of preventing paravalvular leakage according to claim 1, characterized in that: A plurality of anchoring members are provided at one end of the proximal large horn portion away from the distal small horn portion, and the plurality of anchoring members are connected to the ends of the plurality of metal wires uniformly or unevenly in the circumferential direction.

9. The percutaneously implantable artificial aortic valve capable of preventing paravalvular leakage according to claim 1 or 8, characterized in that: It also includes an artificial valve and a skirt. The artificial valve is placed in the valve stent at a cross-sectional position corresponding to the middle waist. The skirt is wrapped around the small trumpet portion at the distal end. The skirt is annular and extends toward the end where blood flows in. The outer wall of the skirt is used to abut and seal with the leaflets of the aortic valve.

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