Percutaneous implantation artificial aortic valve capable of automatically filling perivalvular leakage gap

Abstract

The embodiment of the utility model provides a percutaneous implantation artificial aortic valve capable of automatically filling a perivalvular leakage gap, and relates to the field of medical instruments. Comprising a valve support, the valve support is of a double-horn-shaped net structure formed by weaving metal wires, expansion layers are arranged on the opposite side walls of the metal wires corresponding to the waist of the valve support, the expansion layers correspond to the valve support in the circumferential direction, the expansion layers are made of expansion materials, and the expansion materials can expand after making contact with blood. The expansion layer is arranged on the waist portion of the valve support in the circumferential direction, the expansion layer is made of the expansion material, the expansion material absorbs moisture in blood after being connected with the blood and expands, the gap between the valve ring and the metal wire can be filled, and therefore the perivalvular leakage phenomenon is further reduced. After the stent is implanted into the aortic valve, a perivalvular leakage gap can be automatically filled, and perivalvular leakage is reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a percutaneous implantable artificial aortic valve that can automatically fill the perivalvular leakage gap. Background Technology

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

[0003] For severe aortic stenosis, we will first consider surgical aortic valve replacement (SAVR). For elderly patients and those at high surgical risk, open-heart surgery may be difficult to perform. In such cases, we will consider transcatheter aortic valve implantation (TAVI). TAVI is a minimally invasive procedure that uses a catheter to load an artificial valve and place it inside the heart. A thin catheter is used to place the artificial valve into the patient's aortic valve.

[0004] In the prior art, medical devices using this method mainly include valve stents and artificial valves placed within valve stents. When a valve stent is placed in the aorta, it needs to expand on its own to abut against the aortic tissue, thereby fixing the valve stent in place.

[0005] Valve stents have a mesh-like structure and rely solely on their sides to abut against the aortic tissue for sealing. This sealing effect is relatively poor, posing a risk of paravalvular leakage. Paravalvular leakage refers to a residual leak between the artificial valve annulus and the patient's valve annulus after valve replacement surgery, which poses a significant health risk. During implantation, the valve stent's expansion is used to try and match the diseased valve annulus, which can reduce paravalvular leakage to some extent. However, due to the irregular morphology of the blood vessel wall caused by autocalcification and the annulus dilation due to heart failure, the valve stent and annulus may not match perfectly, leading to increased gaps and still resulting in varying degrees of paravalvular leakage and peripheral regurgitation. Utility Model Content

[0006] In view of the above problems, the present invention provides a percutaneous implantable aortic valve that can automatically fill the paravalvular leak gap, thereby overcoming or at least partially solving the above problems.

[0007] A percutaneous implantable artificial aortic valve capable of automatically filling the perivalvular leakage gap includes a valve stent. The valve stent is formed by a double-trumpet-shaped mesh structure woven from metal wires. An expansion layer is provided on the opposite sidewall of the metal wires corresponding to the waist of the valve stent. The expansion layer corresponds to the circumference of the valve stent. The expansion layer is made of an expansion material that expands upon contact with blood.

[0008] Preferably, the expansion material is coated on the outer wall of the metal wire to form an expansion layer.

[0009] Preferably, the thickness of the expansion layer is 0.05mm-0.6mm.

[0010] Preferably, the metal wire corresponding to the middle waist has multiple grooves on its opposite sidewall, and the expansion material is filled in the grooves to form the expansion layer.

[0011] Preferably, the depth of the groove is 0.05mm-0.6mm, and the length of the groove is 1.0mm-3.0mm.

[0012] Preferably, the groove is laser-engraved onto the metal wire.

[0013] Preferably, the diameter of the metal wire is 0.2mm-0.6mm.

[0014] Preferably, the expanding material is a biocompatible polymer.

[0015] Preferably, it further includes an artificial valve, an anchor, and a skirt. The artificial valve is placed in the valve stent near the waist of the cross-section. The anchor is located at the end of the valve stent facing the blood outflow direction. Multiple anchors are circumferentially and uniformly or unevenly connected to the ends of multiple metal wires. The skirt covers the end of the valve stent facing the blood inflow direction and is annular, extending towards the blood inflow direction. The outer wall of the skirt is used to abut and seal against the leaflets of the aortic valve.

[0016] This application specifically includes the following advantages:

[0017] In the embodiments of this application, a valve stent is used. The valve stent is a double-flare-shaped mesh structure woven from metal wires. An expansion layer is provided on the opposite sidewall of the metal wires corresponding to the waist of the valve stent. The expansion layer corresponds circumferentially to the valve stent and is made of an expansion material that expands upon contact with blood. By providing an expansion layer at the waist of the valve stent, and by using an expansion material that absorbs water from the blood and expands upon contact with blood, the expansion layer can fill the gap between the valve annulus and the metal wires, thereby further reducing paravalvular leakage. Furthermore, by placing the expansion layer on opposite sides of the metal wires, not opposite the intima, the expansion layer's influence on stent fixation is avoided. The stent of this application can automatically fill the paravalvular leakage gap after implantation into the aortic valve, reducing the occurrence of paravalvular leakage. Attached Figure Description

[0018] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the structure of the percutaneous implantable artificial aortic valve that can automatically fill the perivalvular leakage gap provided by this utility model;

[0020] Figure 2 This is a longitudinal cross-sectional view of the metal wire provided by this utility model;

[0021] Reference numerals: 100, metal wire; 200, proximal large trumpet section; 210, anchor; 300, middle waist; 310, groove; 311, expansion layer; 400, distal small trumpet section; 500, artificial valve; 600, skirt. Detailed Implementation

[0022] To make the objectives, features, and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0023] Reference Figure 1-2This diagram illustrates the structure of a percutaneously implantable artificial aortic valve that can automatically fill the perivalvular leakage gap according to the present invention. Specifically, it may include the following structure: a valve stent, wherein the valve stent is woven from metal wires 100 to form a double-flange-shaped mesh structure, and an expansion layer 311 is provided on the opposite sidewall of the metal wires 100 corresponding to the waist of the valve stent. The expansion layer 311 corresponds to the circumference of the valve stent, and the expansion layer 311 is made of an expansion material that expands upon contact with blood.

[0024] In the embodiments of this application, a valve stent is used. The valve stent is woven from metal wires 100 to form a double-flare-shaped mesh structure. An expansion layer 311 is provided on the opposite sidewall of the metal wires 100 corresponding to the waist of the valve stent. The expansion layer 311 corresponds to the circumference of the valve stent and is made of an expansion material that expands upon contact with blood. By circumferentially providing the expansion layer 311 at the waist of the valve stent, and by using an expansion material that absorbs water from the blood and expands upon contact with blood, the expansion layer 311 can fill the gap between the valve annulus and the metal wires 100, thereby further reducing paravalvular leakage. Furthermore, by placing the expansion layer 311 on opposite sides of the metal wires 100, not opposite the intima, the expansion layer 311 avoids affecting stent fixation. The stent of this application can automatically fill the paravalvular leakage gap after implantation into the aortic valve, reducing the occurrence of paravalvular leakage.

[0025] The following will further describe a percutaneous implantable aortic valve capable of automatically filling the perivalvular leak gap in this exemplary embodiment.

[0026] In this embodiment, the valve stent is double-flare shaped. The valve stent is woven from metal wires 100 to form a diamond-shaped mesh structure. The valve stent includes a proximal large flare portion 200, a middle waist portion 300, and a distal small flare portion 400. The diameter of the proximal large flare portion 200 is 25 mm, the diameter of the middle waist portion 300 is 22 mm, the waist portion is 14 mm long, and the diameter of the distal small flare portion 400 is 24 mm. The diameter of the metal wires 100 is 0.2 mm to 0.6 mm. An expansion layer 311 is provided on the opposite sidewall of the metal wire 100 located at the middle waist 300. The middle waist 300 corresponds to the location of the valve annulus. The expansion layer 311 corresponds to the circumferential direction of the valve stent, that is, the expansion layer 311 is provided on the sidewall of the metal wire 100 along the circumferential direction of the stent. The expansion layer 311 is not located on the outer wall of the stent and will not affect the fixation of the stent. The expansion layer 311 is made of an expansion material that expands upon contact with blood. When the valve stent is percutaneously implanted into the aortic valve, the expansion layer 311 is located on the outer wall of the metal wire 100. Upon contact with blood, it absorbs water from the blood and expands, filling the gap between the valve annulus and the metal wire 100, thereby reducing the occurrence of paravalvular leakage. The self-expanding and self-filling design can solve problems such as irregular morphology of the vascular wall after autologous calcification and increased gap due to valve annular dilation caused by heart failure. Moreover, the flexible self-filling method avoids the discomfort caused to patients by protrusions or other structures in the waist area, as is the case with existing technologies.

[0027] As an example, the expansion material is coated onto the outer wall of the metal wire 100 to form an expansion layer 311, the thickness of which is 0.05mm-0.6mm. The expansion material is coated onto the outer wall of the metal wire 100, and the coating thickness can be designed according to the thickness of the metal wire 100 and other requirements; the operation is simple and convenient.

[0028] As an example, the outer wall of the metal wire 100 corresponding to the middle waist 300 is provided with a plurality of grooves 310, and the expansion material is filled in the grooves 310 to form the expansion layer 311. The expansion material is filled in the second groove 312 to form the expansion layer 311. By setting the expansion layer 311 by filling, the expansion time can be slowed down, so that the stent expands and self-fills for a period of time after implantation, accurately filling the gap position.

[0029] Specifically, the diameter of the metal wire 100 is 0.2mm-0.6mm, the depth of the groove 310 is 0.05mm-0.6mm, and the length of the groove 310 is 1.0mm-3.0mm. Setting the depth of the groove 310 to be less than or equal to the radius of the metal wire 100 prevents the metal wire 100 at the middle waist position from being too weak to easily deform or break.

[0030] In one specific embodiment, the diameter of the metal wire 100 is 0.2 mm, the depth of the groove 310 is 0.1 mm, and the length of the groove 310 is 1 mm.

[0031] Furthermore, the groove 310 is laser-engraved onto the metal wire 100. Since the diameter of the metal wire 100 is small, laser engraving is used to create grooves on the metal wire 100, which facilitates operation.

[0032] As an example, the expandable material is a biocompatible polymer. Biocompatibility refers to the ability of a material to adapt to blood without causing any rejection reactions, thus preventing further damage to the patient. By expanding upon contact with blood, the expandable material effectively fills the gap between the valve annulus and the metal wire 100, ensuring safety and thus preventing paravalvular leakage.

[0033] As an example, the outer wall of the wire 100 can also be configured with a rough surface structure, i.e., the side in contact with the intima. For example, its outer wall can be provided with several protrusions or grooves to form an uneven, rough surface, increasing the friction between the rough surface and the inner wall of the aorta, thereby stimulating intimal hyperplasia, reducing the gap between the wire 100 and the valve annulus, and further reducing paravalvular leakage. Preferably, the grooves are configured as several parallel grooves, which does not increase the volume of the stent but also makes the outer wall of the wire rough.

[0034] As an example, the preferred material for manufacturing valve stents is nickel-titanium alloy, which is a shape memory alloy that can shrink and expand to restore its shape. It also has good wear resistance and corrosion resistance, and can effectively achieve overall shrinkage and expansion.

[0035] In this embodiment, the device further includes an artificial valve 500, an anchor 210, and a skirt 600. The artificial valve 500 is placed inside the valve stent near the waist of the cross section. The anchor 210 is located at the end of the valve stent facing the blood outflow direction. Multiple anchors 210 are circumferentially and uniformly or unevenly connected to the ends of multiple metal wires 100, i.e., the proximal large flared portion 200. The skirt 600 covers the end of the valve stent facing the blood inflow direction, and the skirt 600 is annular and extends towards the blood inflow direction, i.e., the distal small flared portion 400. The outer wall of the skirt 600 is used to abut and seal with the leaflets of the aortic valve. The artificial valve 500 is housed within the valve stent. Specifically, the artificial valve 500 is sewn onto the cross-section of the valve stent, dividing the valve stent into two regions. One region faces the blood outflow end of the aortic valve, communicating with the aortic lumen; the other region faces the blood inflow end of the aortic valve, communicating with the left ventricle. The anchor 210 increases the contact area between the support portion and the inner wall of the aorta, enhancing fixation. It can also be connected to a delivery device. The hook at the front end of the delivery device passes through the anchor 210, pushing the valve stent forward and into the blood vessel for release. It can also be retrieved; a safety rope is threaded through the anchor 210. After confirming the correct release position, the safety rope is retrieved. If the release position is incorrect and adjustment is needed, the valve stent can be pulled back into the sheath via the safety rope.

[0036] The skirt 600 covers the distal flared portion 400, and the skirt 600 is annular and extends towards the blood inflow end. The outer wall of the skirt 600 is used to abut and seal against the leaflets of the aortic valve. The skirt 600 is made of polyethylene terephthalate, polytetrafluoroethylene, bovine pericardium, or porcine pericardium. Through the above technical solution, polyethylene terephthalate has excellent physical and mechanical properties, creep resistance, fatigue resistance, abrasion resistance, and dimensional stability. Polytetrafluoroethylene has an extremely low coefficient of friction and is chemically stable, corrosion-resistant, and has strong sealing properties. Bovine and porcine pericardium have good biocompatibility, low antigenicity, and are less prone to rejection reactions. Therefore, they can be used to manufacture structures such as the skirt 600 that come into direct contact with human tissue.

[0037] Although preferred embodiments of the present invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the present invention.

[0038] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or terminal device that includes said element.

[0039] The above provides a detailed description of a percutaneous implantable artificial aortic valve that can automatically fill the perivalvular leakage gap provided by this utility model. Specific examples have been used to illustrate the principle and implementation of this utility model. The description of the above embodiments is only for the purpose of helping to understand the method and core idea of ​​this utility model. At the same time, for those skilled in the art, there will be changes in the specific implementation and application scope based on the idea of ​​this utility model. Therefore, the content of this specification should not be construed as a limitation of this utility model.

Claims

1. A percutaneously implantable artificial aortic valve capable of automatically filling the paravalvular leakage space, comprising a valve stent, wherein the valve stent is a double-flap-shaped mesh structure woven from metal wires, characterized in that, An expansion layer is provided on the opposite sidewall of the metal wire corresponding to the waist of the valve stent. The expansion layer corresponds to the circumference of the valve stent and is made of an expansion material that expands upon contact with blood.

2. The percutaneously implantable artificial aortic valve with automatic filling of the paravalvular leakage space according to claim 1, characterized in that, The expansion material is coated on the outer wall of the metal wire to form an expansion layer.

3. The percutaneously implantable artificial aortic valve capable of automatically filling the paravalvular leakage gap according to claim 2, characterized in that, The thickness of the expansion layer is 0.05mm-0.6mm.

4. The percutaneous implantable aortic valve capable of automatically filling the paravalvular leakage space according to claim 1, characterized in that, Multiple grooves are formed on the opposite sidewalls of the metal wire corresponding to the middle waist section, and the expansion material is filled in the grooves to form the expansion layer.

5. The percutaneous implantable aortic valve capable of automatically filling the paravalvular leakage space according to claim 4, characterized in that, The groove has a depth of 0.05mm-0.6mm and a length of 1.0mm-3.0mm.

6. The percutaneous implantable aortic valve with automatic filling of the paravalvular leakage space according to claim 4, characterized in that, The groove is laser-engraved onto the metal wire.

7. The percutaneously implantable artificial aortic valve with automatic filling of the paravalvular leakage space according to claim 3 or 5, characterized in that, The diameter of the metal wire is 0.2mm-0.6mm.

8. The percutaneously implantable artificial aortic valve with automatic filling of the paravalvular leakage space according to claim 2 or 4, characterized in that, The expansion material is a biocompatible polymer.

9. The percutaneous implantable aortic valve capable of automatically filling the paravalvular leakage space according to claim 1, characterized in that, It also includes an artificial valve, anchors, and a skirt. The artificial valve is placed inside the valve stent near the waist of the cross-section. The anchors are located at the end of the valve stent facing the blood outflow direction. Multiple anchors are circumferentially and uniformly or unevenly connected to the ends of multiple metal wires. The skirt covers the end of the valve stent facing the blood inflow direction and is annular, extending towards the blood inflow direction. The outer wall of the skirt is used to abut and seal against the leaflets of the aortic valve.

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