A valve

Abstract

This application relates to a valve, which includes: a valve frame; valve leaflets, which are mounted on the valve frame; a skirt, which is mounted on the valve frame; wherein, the area of the skirt is greater than or equal to the area of the valve frame, so that the skirt can move freely. After this valve is implanted into the human body, since the skirt can move freely, it can fill the gap between the valve and the surrounding annulus under the pressure of blood, making the valve fit tightly with the surrounding annulus after being implanted into the human body, preventing blood from flowing from the edge of the valve into the ventricle, reducing the occurrence of paravalvular leakage, and ultimately achieving the therapeutic purpose.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a valve. Background Art

[0002] Traditional cardiac valve replacement surgery is an open and highly invasive procedure. The surgical trauma is large and requires extracorporeal circulation, with a very high surgical risk. Moreover, adverse reactions such as massive bleeding, infection, and arrhythmia are likely to occur during the surgery, resulting in patients even needing several months to recover. Although the transapical aortic valve replacement has a small surgical incision, it still causes trauma to the patient's heart and brings long-term pain during the recovery process. In recent years, researchers have been committed to realizing artificial heart valve replacement without opening the chest or placing the patient on extracorporeal circulation, aiming to minimize the trauma. This biological valve can be arranged through the patient's own valve, thus avoiding resection of the diseased valve of the patient.

[0003] One end of the skirt of the traditional valve is connected and fixed to the valve leaf, and the other end is connected and fixed to the bottom end of the stent. The valve is compressed in the catheter. During percutaneous transcatheter heart valve replacement, it is expanded at the desired position through balloon inflation to replace the native valve. However, there is a risk of paravalvular leakage in the existing native valves. When the paravalvular leakage is severe, it will cause complications such as chest tightness, shortness of breath, hemolysis, anemia, and angina in patients after surgery. Summary of the Invention

[0004] This application provides a valve that can reduce the risk of paravalvular leakage and improve safety.

[0005] An embodiment of this application provides a valve, which includes:

[0006] A valve frame;

[0007] Valve leafs, which are installed on the valve frame;

[0008] A skirt, which is installed on the valve frame;

[0009] Wherein, the area of the skirt is greater than or equal to the area of the valve frame, so that the skirt can move freely.

[0010] In a possible design, along the circumferential direction of the valve frame, the skirt is closed.

[0011] In a possible design, along the height direction of the valve frame, the skirt includes a top end and a bottom end, and the top end and the bottom end are installed on the valve frame;

[0012] Between the top end and the bottom end, the area of the skirt is greater than the area of the valve frame, and the skirt near the top end and the skirt near the bottom end are connected to form an annular structure or a pleated structure.

[0013] In a possible design, the valve frame includes a plurality of first mounting openings, and the skirt is mounted in the first mounting openings and seals the first mounting openings;

[0014] Along a second direction, the plurality of first mounting openings are located at the same height, so that the skirt is an annular structure.

[0015] In a possible design, the valve frame includes a plurality of first mounting openings, and the skirt is mounted in the first mounting openings and seals the first mounting openings;

[0016] Along a second direction, the plurality of first mounting openings are located at different heights, so that the skirt is a corrugated structure.

[0017] In a possible design, the skirt is a single-layer structure, and a part of the skirt is located inside the valve frame, and the other part extends out of the valve frame through the first mounting opening.

[0018] In a possible design, the skirt is sewn to the valve frame through the first mounting opening.

[0019] In a possible design, the valve frame includes a second mounting opening, and the valve leaflet is mounted in the second mounting opening and seals the second mounting opening;

[0020] A second supporting portion is provided at the second mounting opening, and the second supporting portion is used to support the valve leaflet along a first direction.

[0021] In a possible design, the valve is a balloon-expandable valve.

[0022] After the valve is implanted into the human body, since the skirt can move freely, it can fill the gap between the valve and the surrounding annulus under the pressure of the blood, so that the valve is closely attached to the surrounding annulus after being implanted into the human body, preventing blood from flowing from the edge of the valve into the ventricle, reducing the occurrence of paravalvular leakage, and finally achieving the therapeutic purpose.

[0023] It should be understood that the above general description and the following detailed description are only exemplary and do not limit the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a schematic structural diagram of the valve provided by the present application in a first specific embodiment;

[0025] Figure 2 is a schematic structural diagram of the valve provided by the present application in another specific embodiment;

[0026] Figure 3 is Figure 1 and Figure 2Partial structural schematic diagram of the valve support in the first specific embodiment;

[0027] Figure 4 is Figure 1 and Figure 2 Partial structural schematic diagram of the valve support in the second specific embodiment;

[0028] Figure 5 is Figure 1 Partial structural schematic diagram of the valve support;

[0029] Figure 6 is Figure 2 Structural schematic diagram of the valve support;

[0030] Figure 7 is Figure 1 and Figure 2 Partial structural schematic diagram of the valve support in the third specific embodiment;

[0031] Figure 8 is Figure 1 and Figure 2 Top view of the valve leaf in;

[0032] Reference numerals:

[0033] 1 - Valve support;

[0034] 11 - Body part;

[0035] 111 - First mounting port;

[0036] 112 - Second mounting port;

[0037] 12 - Valve orifice;

[0038] 121 - Side wall;

[0039] 13 - First support part;

[0040] 131 - First section;

[0041] 132 - Second section;

[0042] 14 - Second support part;

[0043] 2 - Valve leaf;

[0044] 21 - First valve leaf;

[0045] 22 - Second valve leaf;

[0046] 23 - Third valve leaf;

[0047] 3 - Skirt;

[0048] X - First direction;

[0049] Y-second direction.

[0050] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application. DETAILED DESCRIPTION

[0051] In order to better understand the technical solution of the present application, the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0052] It should be clear that the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0053] The terms used in the embodiments of the present application are for the purpose of describing specific embodiments only and are not intended to limit the present application. The singular forms "a", "an", "the" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms unless the context clearly indicates otherwise.

[0054] It should be understood that the term "and / or" used in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0055] It should be noted that the directional words such as "upper", "lower", "left", and "right" described in the embodiments of the present application are described based on the angles shown in the accompanying drawings and should not be understood as limiting the embodiments of the present application. In addition, in the context, it should be understood that when it is mentioned that an element is connected to another element "on" or "under", it can not only be directly connected to the other element "on" or "under", but also be indirectly connected to the other element "on" or "under" through an intermediate element.

[0056] The embodiment of the present application provides a valve and a valve frame 1 thereof, such as Figure 1 and Figure 2 As shown, the valve comprises a frame 1, leaflets 2, and a skirt 3. Both the leaflets 2 and skirt 3 are mounted on the frame 1, with the leaflets 2 positioned within the space formed by the frame 1. The frame 1 can be a grid-like structure, and the skirt, through various designs and sewing techniques, blocks the grid of the frame 1, preventing blood from flowing back through the native valve slits during cardiac regurgitation. The skirt 3 can be made of PET, PTFE, or biological tissue materials.

[0057] The expansion methods of the valve can include balloon expansion type and self-expansion type. For the balloon expansion method, a balloon is placed in the transcatheter aortic valve. After the valve is input into the body through the delivery system, the balloon is expanded by pressurization, which then drives the valve to expand and anchor at the diseased position. The self-expansion method realizes expansion through the inherent characteristics of the stent material of the transcatheter aortic valve. When implanted into the human body, the transcatheter aortic valve is radially compressed and placed in the catheter of the delivery system. After being implanted into the human body, the catheter is withdrawn, enabling the valve to self-expand to its original size without restraint and anchor at the diseased position. Therefore, a valve with a balloon expansion method is a balloon-expandable valve, and a valve with a self-expansion method is a self-expanding valve.

[0058] After the valve is implanted into the human body, taking the Figure 1 and Figure 2 shown perspectives as an example, blood flows from top to bottom. Under the pressure of the blood, the valve leaflet 2 is opened, thus opening the blood passage of the valve. At this time, the valve is in the open state. When the pressure of the blood disappears, the valve leaflet 2 can deform and close, thereby blocking the blood passage of the valve and preventing blood backflow. At this time, the valve is in the closed state. At the same time, after the valve is implanted into the human body, it can usually be supported at the diseased valve of the human body, thus replacing the diseased valve to work. Therefore, it is necessary to ensure the position of the valve after being implanted into the human body, that is, to prevent the valve from falling off after being implanted into the human body.

[0059] One end of the skirt 3 of the traditional valve is fixedly connected to the valve leaflet 2, and the other end is fixedly connected to the bottom end of the stent 1. The valve is compressed in the catheter. During percutaneous transcatheter heart valve replacement, it is expanded at the required position by balloon inflation, thus replacing the native valve. However, for the native valve, either the opening and closing of the valve leaflet 2 are asynchronous, resulting in severe regurgitation, or the valve leaflet 2 is severely calcified and cannot open and close completely. In either case, after the percutaneously implanted valve is implanted, the stent 1 will be less likely to fit closely with the surrounding annulus, allowing blood to flow from the gap at the edge of the valve into the ventricle, causing paravalvular leakage. When the paravalvular leakage is severe, it will lead to complications such as chest tightness, shortness of breath, hemolysis, anemia, and angina pectoris in patients after surgery.

[0060] To solve this technical problem, as shown in Figure 1 and Figure 2 , after the skirt 3 is installed on the stent 1, the area of the skirt 3 is greater than or equal to the area of the stent 1, enabling the skirt 3 to move freely. Therefore, after the valve is implanted into the human body, since the skirt 3 can move freely, it can fill the gap between the valve and the surrounding annulus under the pressure of the blood, making the valve fit closely with the surrounding annulus after being implanted into the human body, preventing blood from flowing from the edge of the valve into the ventricle, reducing the occurrence of paravalvular leakage, and ultimately achieving the treatment purpose.

[0061] More specifically, as shown in Figure 1 and Figure 2As shown, along the circumferential direction of the valve frame 1, the skirt 3 is closed. After the valve is implanted percutaneously, the closed skirt 3 fits more closely to the annulus of the native valve, which can reduce the inflow of blood from the gaps of the valve frame 1 into the patient's ventricle, thereby reducing paravalvular leakage of the valve and reducing the occurrence of complications such as chest tightness, shortness of breath, hemolysis, anemia, and angina after valve replacement in patients, and improving the safety of the valve.

[0062] In a specific embodiment, along the height direction of the valve frame 1, the skirt 3 includes a top end and a bottom end, and the top end and the bottom end are mounted on the valve frame 1. For example, the top end and the bottom end are sewn on the valve frame 1. At the same time, between the top end and the bottom end, the area of the skirt 3 is greater than or equal to the area of the valve frame 1, and the skirt 3 near the top end and the skirt 3 near the bottom end are connected to form an annular structure or a pleated structure.

[0063] In this embodiment, when the area of the skirt 3 between the top end and the bottom end is greater than the area of the valve frame 1, there is a gap between the skirt 3 between the top end and the bottom end and the valve frame 1, which can move freely, so that it can fill the gap between the valve and the surrounding annulus under the pressure of blood, making the valve fit tightly with the surrounding annulus after being implanted into the human body, preventing blood from flowing from the edge of the valve into the ventricle, and reducing the occurrence of paravalvular leakage. At the same time, when the skirt 3 near the top end and the skirt 3 near the bottom end are connected, it helps to form an annular structure or a pleated structure on the skirt 3.

[0064] Among them, when processing the valve, when the top end and the bottom end of the skirt 3 are sewn on the valve frame 1, since the area of the skirt 3 between the top end and the bottom end is greater than the area of the valve frame 1, the skirt 3 can pinch out an annular structure or a pleated structure by itself, and then sew from bottom to top or from top to bottom between the top end and the bottom end with a needle and thread, so as to form an annular structure or a pleated structure.

[0065] In another specific embodiment, as Figure 5 shown, the valve frame 1 includes a plurality of first mounting openings 111, and the skirt 3 is mounted in the first mounting openings 111 and blocks the first mounting openings 111; along the second direction Y, the plurality of first mounting openings 111 are at the same height, so that the skirt 3 is Figure 1 the annular structure shown.

[0066] In still another specific embodiment, as Figure 6 shown, along the second direction Y, the plurality of first mounting openings 111 are at different heights, so that the skirt 3 is a pleated structure.

[0067] In the above two embodiments, the structure formed by the skirt 3 is determined according to the position of each first installation opening 111. That is, when the first installation openings 111 are located at the same height, the skirt 3 forms an annular suture ring. When the heights of the first installation openings 111 are different, the skirt 3 forms an irregularly shaped suture ring. No matter which type, it can fit tightly with the surrounding annular surface after implantation, preventing blood from flowing from the edge of the valve into the ventricle, reducing the occurrence of paravalvular leakage, and ultimately achieving the purpose of treatment.

[0068] In addition, the skirt 3 is sewn to the valve frame 1 at the first installation port 111, so that the valve does not need to provide an additional support frame for the skirt 3, but the skirt 3 is directly sewn to the valve frame 1, thereby simplifying the structure of the valve.

[0069] In the above embodiments, Figure 1 and Figure 2 As shown, the skirt 3 is a single-layer structure, and a portion of the skirt 3 is located inside the petal frame 1 , while the other portion extends out of the petal frame 1 through the first installation opening 111 .

[0070] In this embodiment, when sewing the skirt 3 onto the valve frame 1, the single-layer skirt 3 can be first placed inside the valve frame 1. A portion of the skirt 3 is then extended outside the valve frame 1 through the first mounting opening 111 and sewn at the first mounting opening 111. This results in skirts 3 on both the inside and outside of the valve frame 1, further reducing paravalvular leakage and improving valve performance. Furthermore, when the skirts 3 on both the inside and outside of the valve frame 1 are integrally formed, sewing the skirt 3 is simplified, improving its strength and reliability.

[0071] On the other hand, Figure 3 As shown, the flap frame 1 includes a second mounting opening 112, and the second mounting opening 112 and the first mounting opening 111 are arranged along the second direction Y. The flap 2 is mounted on the second mounting opening 112 and blocks the second mounting opening 112. Figure 3 As shown, the valve frame 1 has three second mounting openings 112, and the valve includes three leaflets 2. The three second mounting openings 112 are all used to mount the leaflets 2 (the leaflets 2 can be mounted on the second mounting openings 112 by sewing or bonding), and the angle between the three second mounting openings 112 is 120°. Figure 8 As shown, the first lobe 21, the second lobe 22 and the third lobe 23 are symmetrically distributed, and the first lobe 21, the second lobe 22 and the third lobe 23 are the same in size.

[0072] like Figure 7 As shown, a second supporting portion 14 is provided at the second mounting opening 112 , and the second supporting portion 14 is used to support the leaflet 2 along the first direction X.

[0073] In this embodiment, when the valve is squeezed before being implanted into the patient's body, the valve frame 1 of the valve is deformed by the squeezing force. By providing the second support portion 14, after the valve frame 1 is deformed and contracts, the second support portion 14 can support the leaflets 2, thereby preventing the leaflets 2 from being crushed by the valve frame 1, thereby improving the safety and reliability of the valve.

[0074] Among them, such as Figure 7 As shown, the second supporting portion 14 can extend along the first direction X, so as to support the leaflet 2 in the radial direction during the process of pressing and gripping the valve.

[0075] In the embodiment of this application, Figures 3 to 7 As shown, the valve frame 1 includes a main body 11, which is provided with multiple valve openings 12, and the valve openings 12 have side walls 121, wherein at least one first support portion 13 is provided in at least part of the valve openings 12, and the first support portion 13 is connected to the side walls 121.

[0076] In this embodiment, by arranging a first support portion 13 in the valve orifice 12 of the valve frame 1, the first support portion 13 can improve the support performance of the valve frame 1 along the first direction X (radial). When the valve is placed in the patient's body, the support force between the valve frame 1 and the patient's diseased valve can be improved, thereby reducing the risk of the valve falling off the diseased valve, improving the position accuracy of the valve, thereby improving the working performance of the valve, and ensuring the safety of the patient.

[0077] Specifically, if Figure 3 and Figure 4 As shown, the first support portion 13 divides the valve opening 12 into at least one quadrilateral structure.

[0078] As mentioned above, the valve needs to expand after being implanted into the patient's body, that is, the valve needs to be deformed, so that the valve frame 1 needs to have good deformation ability. Since the quadrilateral structure has the characteristic of being easily deformed when subjected to force, when the first support part 13 separates the valve opening 12 into a quadrilateral structure, the valve frame 1 has a higher supporting force and also has good deformation ability, thereby improving the performance of the valve.

[0079] In a specific embodiment, Figure 3 As shown, the first support portion 13 includes at least a first section 131 and a second section 132 that are bent relative to each other. Along the first direction X, one end of the first section 131 is connected to one end of the second section 132 , and the other ends of the two are respectively connected to the corresponding side walls 121 .

[0080] In this embodiment, the relatively bent first section 131 and the second section 132 are connected to the two side walls 121 of the valve opening 12 to form a quadrilateral structure. At this time, the first section 131 and the second section 132 can improve the supporting performance of the valve frame 1, that is, when the valve frame 1 is subjected to external force along the first direction X, the first section 131 and the second section 132 can play a supporting role; at the same time, when the valve frame 1 expands, the relatively bent first section 131 and the second section 132 can deform at the position where the two are connected, thereby helping to achieve the expansion of the valve frame 1.

[0081] The included angle between the first section 131 and the second section 132 may be any angle between 0° and 180°, as long as the two sections are not located on the same straight line.

[0082] More specifically, if Figure 3 As shown, the first section 131 , the second section 132 and the side wall 121 have the same length, so that the first section 131 , the second section 132 and the side wall 121 form a diamond shape or a square.

[0083] In this embodiment, when the first section 131, the second section 132 and the side wall 121 form a rhombus or a square, under the action of external force, the rhombus or square structure has a higher stability in deformation under the action of external force, and the rhombus or square structure also has the advantage of easy processing and improves the appearance performance of the petal frame 1.

[0084] like Figure 3 In the illustrated embodiment, after the first support portion 13 is provided, the first support portion 13 separates the valve opening 12 into a quadrilateral structure and a hexagonal structure. During the expansion process of the valve frame 1, both the quadrilateral structure and the hexagonal structure can be deformed.

[0085] In another specific embodiment, Figure 4 As shown, at least two first support portions 13 are provided within the valve orifice 12 along the second direction Y, with a preset distance between adjacent first support portions 13. The preset distance can be set based on actual conditions, as long as the two first support portions 13 do not interfere with each other during the crimping of the valve frame 1. Specifically, during the crimping of the valve frame 1, there is a gap between the two first support portions 13 along the second direction Y, or the two first support portions 13 just touch each other along the second direction Y, thereby preventing the two first support portions 13 from squeezing each other and affecting the expansion of the valve frame 1.

[0086] In this embodiment, when at least two first support portions 13 are provided in the valve opening 12 , the valve opening 12 can be divided into at least two quadrilaterals. When the valve frame 1 expands, the at least two quadrilateral structures can further promote the expansion of the valve frame 1 .

[0087] The two first support portions 13 may each include a first section 131 and a second section 132 that are bent relative to each other, and the first section 131 and the second section 132 are both connected to the side wall 121 of the valve orifice 12. Figure 4 In the illustrated embodiment, along the second direction Y, two first support portions 13 are provided in the valve opening 12 , thereby dividing the valve opening 12 into two quadrilateral structures and one hexagonal structure.

[0088] In the above embodiments, the shape of the petal opening 12 can be a hexagon. Specifically, the shape of the petal opening 12 can be a regular hexagon, that is, the lengths of the side walls 121 of the petal opening 12 are equal.

[0089] In this embodiment, when the hexagonal valve opening 12 is subjected to external force, the deformation amount at each location is similar, so that the valve frame 1 can expand evenly, improving the performance of the valve in the patient's body. At the same time, it can also simplify the structure of the valve frame 1 and improve the appearance performance of the valve.

[0090] On the other hand, the material of the valve frame 1 includes cobalt-chromium alloy or nickel-titanium.

[0091] At the same time, the first support portion 13 is provided at the flap 12 corresponding to the skirt 3 .

[0092] The valve described in the embodiments of the present application is a balloon-expandable valve.

[0093] As mentioned above, valve expansion methods include self-expanding and balloon-expanding. For self-expanding valves, due to the greater height of their valve frame 1, future "valve-in-valve" replacement surgeries for patients who have already used self-expanding valves may expose the newly implanted self-expanding valve to the risk of blocking the entrance to the coronary arteries. However, the valve frame 1 of a balloon-expandable valve is much shorter than that of a self-expanding valve. Therefore, subsequent "valve-in-valve" replacement surgeries will not obstruct the entrance to the coronary arteries. Therefore, balloon-expandable valves offer greater safety.

[0094] In addition, the valve in the embodiment of the present application is a balloon-expandable valve, so when the skirt 3 is sewn to the valve frame 1, compared with the self-expanding valve, the circumferential closed structure of the skirt 3 can be achieved without a traction rope, thereby simplifying the structure of the valve.

[0095] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A valve, characterized in that, The valve includes: a valve frame (1), the valve frame (1) including a plurality of first mounting openings (111); valve leaflets (2), the valve leaflets (2) being mounted on the valve frame (1); a skirt (3), the skirt (3) being mounted on the valve frame (1); wherein, the area of the skirt (3) is greater than or equal to the area of the valve frame (1) so that the skirt (3) can move freely; the skirt (3) is of a single-layer structure, and a part of the skirt (3) is located inside the valve frame (1), and the other part extends out of the valve frame (1) through the first mounting opening (111); the valve frame (1) includes a second mounting opening (112), and the first mounting opening (111) and the second mounting opening (112) are distributed along a second direction (Y); the valve leaflets (2) are mounted on the second mounting opening (112) and block the second mounting opening (112); a second support portion (14) is provided at the second mounting opening (112), and the second support portion (14) is used to support the valve leaflets (2) along a first direction (X).

2. The valve according to claim 1, characterized in that, Along the circumferential direction of the valve frame (1), the skirt (3) is closed.

3. The valve according to claim 2, characterized in that, Along the height direction of the valve frame (1), the skirt (3) includes a top end and a bottom end, and the top end and the bottom end are mounted on the valve frame (1); Between the top end and the bottom end, the area of the skirt (3) is greater than or equal to the area of the valve frame (1), and the skirt (3) near the top end and the skirt (3) near the bottom end are connected to form an annular structure or a pleated structure.

4. The valve according to claim 2, wherein The skirt (3) is mounted on the first mounting opening (111) and blocks the first mounting opening (111); Along the second direction (Y), the plurality of first mounting openings (111) are at the same height so that the skirt (3) is of an annular structure.

5. The valve according to claim 2, wherein, The skirt (3) is mounted on the first mounting opening (111) and blocks the first mounting opening (111); Along the second direction (Y), the plurality of first mounting openings (111) are at different heights so that the skirt (3) is of a pleated structure.

6. The valve according to claim 4 or 5, characterized in that, The skirt (3) is sewn to the valve frame (1) through the first mounting opening (111).

7. The valve according to any one of claims 1 to 5, characterized in that, The valve is a balloon-expandable valve.

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