Outer coating cloth and heart valve prosthesis

Abstract

The invention relates to outer wrapping cloth and a heart valve prosthesis. The outer wrapping cloth is cylindrical after being folded, the outer wrapping cloth is provided with a plurality of tailoring holes, and the tailoring holes are formed in the circumferential direction of the outer wrapping cloth at intervals; the outer wrapping cloth can be arranged on the valve support in a sleeving mode and attached to the valve support after being folded along the longitudinal axis of the cutting hole. The outer wrapping cloth is accurately attached to the shape of the valve support, a gap between the outer wrapping cloth and the valve support caused by deformation of the valve support is prevented, the outer wrapping cloth is prevented from loosening, the connection strength between the valve support and the outer wrapping cloth is guaranteed, and the heart valve prosthesis structure is prevented from losing efficacy. Moreover, as the outer coating cloth is accurately attached to the valve stent, a cavity can be prevented from being formed between the outer coating cloth and the valve stent, thrombus is further avoided, and the use safety is guaranteed.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an outer covering cloth and a heart valve prosthesis. Background Art

[0002] Heart valves are the gateway to the heart's blood circulation. Once they become narrow or incompletely closed, the heart will be underpowered or fail, resulting in chest tightness, shortness of breath, general edema, weakness, chest pain and other symptoms, which are a hidden danger that endangers the lives and quality of life of the elderly. With the aging of the population and the development of medical technology, valvular heart disease (VHD) has become the third largest cardiovascular disease, seriously endangering human health. At present, replacing the original diseased valve with a biological valve is an important means of treating valvular heart disease.

[0003] For current surgical valve products, the outer surface of conventional implant prostheses is covered with fabric, and the components are connected by suturing the fabric. Since surgical valve stents are irregular three-dimensional shapes, the traditional flat covering cloth cannot completely fit the stent components when wrapped and connected, which will affect the connection strength between the components and may cause the valve prosthesis structure to fail. At the same time, there is a risk of thrombosis in the middle cavity. Summary of the invention

[0004] Based on this, it is necessary to provide an outer covering cloth and a heart valve prosthesis that can accurately fit the shape of the valve stent, ensure the connection strength between the valve stent and the outer covering cloth, and avoid the occurrence of thrombosis in order to address the problem that the current flat covering cloth cannot accurately fit the stent, resulting in weak connection strength and thrombosis.

[0005] An outer covering cloth, the outer covering cloth is folded into a cylindrical shape, the outer covering cloth has a plurality of cutting holes, and the plurality of cutting holes are arranged at intervals along the circumferential direction of the outer covering cloth;

[0006] The outer covering cloth can be sleeved on the valve stent after being folded along the longitudinal axis of the cutting hole, and fits the valve stent.

[0007] In one embodiment of the present application, the outer covering cloth has radial elasticity and can be stretched to the outer diameter of the valve stent by elastic extension;

[0008] The radial elastic elongation of the outer covering cloth is ≥340%.

[0009] In one embodiment of the present application, the outer covering cloth includes a first covering portion, a second covering portion and a third covering portion, the second covering portion connects the first covering portion and the third covering portion, and the second covering portion has the cutting hole;

[0010] After the outer covering cloth is folded, the second covering portion covers the petal corner, the first covering portion covers the outer surface of the petal seat, and the third covering portion covers the inner surface of the petal seat.

[0011] In one embodiment of the present application, the first covering portion, the second covering portion and the third covering portion are an integral structure.

[0012] In one embodiment of the present application, the axial length of the second covering portion is less than or equal to twice the axial length of the petal angle.

[0013] In one embodiment of the present application, the second covering portion includes a covering section and a transition section, both ends of the covering section are respectively connected to the transition section, and the first covering portion and the third covering portion are connected through the transition section;

[0014] The side surface of the transition section has an arc-shaped edge.

[0015] In one embodiment of the present application, the width of the coating section is ≥4 mm;

[0016] The width of the transition section ranges from 20 mm to 40 mm.

[0017] In one embodiment of the present application, the axial length of the third covering portion is longer than the axial length of the first covering portion.

[0018] In one embodiment of the present application, the axial length of the third covering portion differs from the axial length of the first covering portion by 0.5 mm to 2 mm.

[0019] In one embodiment of the present application, the edge of the third covering portion wraps the edge of the first covering portion outwardly and is folded at least once, with each fold being 1 mm to 2 mm, to form a reinforced edge with a thickness of 1 mm to 2 mm.

[0020] In one embodiment of the present application, the diameter of the outer covering cloth in a natural state is smaller than the diameter of the smallest end of the valve stent;

[0021] The outer diameter of the valve stent is a, and the diameter of the outer covering cloth in a natural state is b, wherein:

[0022] In one embodiment of the present application, the diameter of the outer covering cloth ranges from 18 mm to 26 mm;

[0023] The angle between two connected braided wires in the outer covering fabric ranges from 90° to 135°;

[0024] The porosity of the outer covering cloth is less than 30%.

[0025] In one embodiment of the present application, the axial length C of the outer covering cloth is determined according to the axial height H of the valve stent, wherein C≥2H+2.

[0026] A heart valve prosthesis comprises a valve support, a valve frame, valve leaflets and an outer covering cloth as described in any of the above technical features, wherein the valve frame is arranged on the valve support, the valve leaflets are connected to the valve frame, and the outer covering cloth covers the valve support.

[0027] After adopting the above technical solution, this application has at least the following technical effects:

[0028] The outer covering cloth and the heart valve prosthesis of the present application are provided with a cylindrical outer covering cloth, and a plurality of cutting holes are provided in the middle area of ​​the cylindrical outer covering cloth, and the plurality of cutting holes are provided in the circumferential direction. When the outer covering cloth covers the valve stent, the outer covering cloth is folded, the edge of the cutting hole covers the valve angle of the valve stent, and the rest of the outer covering cloth covers the valve seat of the valve stent. In this way, the outer covering cloth accurately fits the shape of the valve stent, and a gap between the outer covering cloth and the valve stent is prevented due to deformation of the valve stent, thereby preventing the outer covering cloth from becoming loose, so as to ensure the connection strength between the valve stent and the outer covering cloth, and avoid failure of the heart valve prosthesis structure. Moreover, since the outer covering cloth accurately fits the valve stent, a cavity between the outer covering cloth and the valve stent can be avoided, thereby avoiding the occurrence of thrombus, and ensuring safety during use. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic diagram of a valve stent not covered with an outer covering cloth according to an embodiment of the present application viewed from a certain angle.

[0030] Figure 2 for Figure 1 The outer covering cloth shown is a schematic diagram viewed from another angle.

[0031] Figure 3 For Figure 1 A schematic structural diagram of a valve stent matched with an outer covering cloth is shown.

[0032] Among them: 100, outer covering cloth; 110, cutting hole; 120, first covering part; 130, second covering part; 131, covering section; 1311, first section; 1312, second section; 132, transition section; 140, third covering part; 200, valve support; 210, valve seat; 220, valve angle; 300, valve frame. DETAILED DESCRIPTION

[0033] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0034] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0035] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0036] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0037] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0038] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0039] See also Figures 1 to 3 The present application provides an outer covering cloth 100. The outer covering cloth 100 covers a valve stent 200 of a heart valve prosthesis. The heart valve prosthesis here mainly refers to an artificial bioprosthetic valve product, such as a surgical aortic valve, mitral valve, and tricuspid valve. Figure 1 This is a schematic diagram of an embodiment of the present application in which the outer covering cloth 100 is not covering the valve stent 200 from one angle. Figure 2 for Figure 1 The outer covering cloth 100 is shown as a schematic diagram from another angle. Figure 3 For Figure 1 A schematic structural diagram of a valve stent 200 matched with an outer covering cloth 100 is shown.

[0040] It is understandable that in current surgical valve products, the flat covering cloth cannot be completely fitted with the stent components, which will affect the connection strength between the components and may cause the valve prosthesis structure to fail. At the same time, there is a risk of thrombosis in the middle cavity. To this end, the present application provides a new type of outer covering cloth 100, which can accurately fit the shape of the valve stent 200 to ensure the connection strength between the valve stent 200 and the outer covering cloth 100. At the same time, it can also avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, thereby avoiding the occurrence of thrombosis and ensuring safety during use. The specific structure of the outer covering cloth 100 of an embodiment is introduced below.

[0041] See also Figures 1 to 3In one embodiment, the outer covering cloth 100 is folded into a cylindrical shape, and the outer covering cloth 100 has a plurality of cutting holes 110, and the plurality of cutting holes 110 are arranged at intervals along the circumferential direction of the outer covering cloth 100. The outer covering cloth 100 can be sleeved on the valve stent 200 after being folded along the longitudinal axis of the cutting holes 110, and fit the valve stent 200. Optionally, the cutting holes 110 are located in the middle area of ​​the outer covering cloth 100. The longitudinal axis O is as shown in FIG. Figure 1 shown.

[0042] The outer covering cloth 100 is a component that covers the valve stent 200. It is woven and formed by braided silk and has a certain elasticity. In this way, when the outer covering cloth 100 covers the valve stent 200, it can make the outer covering cloth 100 accurately fit the irregular shape of the valve stent 200, and then the outer covering cloth 100 can cover the valve angle 220 and the valve seat 210 of the valve stent 200. In order to better illustrate the structure of the outer covering cloth 100, the structure of the valve stent 200 is first described here, and the valve stent 200 with three valve angles 220 is used as an example for explanation. Of course, in other embodiments of the present application, the valve stent 200 may also be a two-leaflet or multi-leaflet structure, which will not be repeated later.

[0043] The heart valve prosthesis includes a valve support 200, a valve frame 300 and a valve leaflet. The valve support 200 is a cobalt-based alloy wire that is formed into three continuous arcs of 120 degrees to form a smooth curve, and after heat treatment, it has good fatigue resistance. The arc at the bottom of the valve support 200 is a valve seat 210, and three protrusions are formed at the connection of the arcs, namely the valve angle 220. The three valve angles 220 and the valve seat 210 at the bottom have a smooth transition. The valve frame 300 is arranged in the valve support 200 along the contour of the valve support 200, and the valve leaflet is arranged in the valve support 200 and connected to the valve frame 300. The bottom of the valve support 200 is a circular or irregular shape, the direction of the valve seat 210 at the bottom of the valve support 200 is the direction of the inflow channel, and the direction of the valve angle 220 is the direction of the outflow channel, and the blood flows from the inflow channel direction to the outflow channel direction.

[0044] The outer covering cloth 100 is arranged in a cylindrical shape, and a plurality of cutting holes 110 are arranged in the middle area thereof, and the plurality of cutting holes 110 are arranged at intervals in the circumferential direction. It can be understood that the valve stent 200 has three petal angles 220, and here only the outer covering cloth 100 having three cutting holes 110 is used as an example for explanation. That is, the number of cutting holes 110 on the outer covering cloth 100 is equal to the number of petal angles 220 and leaflets, and the cutting holes 110 are formed by cutting equidistantly in the circumferential direction, and the petal angles 220 are covered by the fabric between the two cutting holes 110. The three cutting holes 110 are evenly distributed in the middle area of ​​the outer covering cloth 100. When the outer covering cloth 100 covers the valve stent 200, the outer covering cloth 100 is folded along the cutting holes 110 in the middle area, and the cylindrical outer covering cloth 100 can cover the valve stent 200.

[0045] Specifically, after the outer covering cloth 100 is folded, the outer covering cloth 100 is a double-layer structure, and the outer covering cloth 100 is sleeved on the valve stent 200, so that the outer covering cloth 100 of the outer layer can fit the outer side of the valve stent 200, and the inner covering cloth 100 of the inner layer can fit the inner side of the valve stent 200, and the outer covering cloth 100 at the edge of the cutting hole 110 covers the valve angle 220, and the remaining part of the outer covering cloth 100 covers the valve seat 210. After the outer covering cloth 100 is sutured, the valve stent 200 can be covered. In this way, the outer covering cloth 100 can adapt to the shape of the valve stent 200, so as to better fit the valve stent 200 and avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200.

[0046] The outer covering cloth 100 of the above embodiment is provided in a cylindrical structure, and after the cutting hole 110 is provided thereon, it can accurately fit the shape of the valve stent 200, prevent the gap between the outer covering cloth 100 and the valve stent 200 caused by the deformation of the valve stent 200, and further prevent the outer covering cloth 100 from becoming loose, so as to ensure the connection strength between the valve stent 200 and the outer covering cloth 100, and prevent the failure of the heart valve prosthesis structure. Moreover, since the outer covering cloth 100 accurately fits the valve stent 200, it can avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, and further prevent the occurrence of thrombus, thereby ensuring safety during use.

[0047] In one embodiment, the outer covering cloth 100 has an axial opening. That is, the outer covering cloth 100 is provided in a sheet shape, which can be arranged in a cylindrical structure. Thus, the outer covering cloth 100 can be conveniently folded through the opening and conveniently sleeved on the valve stent 200.

[0048] In one embodiment, the outer covering cloth 100 has radial elasticity and can be stretched to the outer diameter of the valve stent 200 by elastic extension. It can be understood that the outer contour of the valve stent 200 is approximately circular or circular, and the central axis direction of the valve stent 200 is the axial direction. Correspondingly, the direction perpendicular to the central axis direction and extending along the radial direction is the radial direction. The outer covering cloth 100 can fit the outer surface contour of the valve stent 200 through elasticity and can adapt to the deformation of the valve stent 200.

[0049] Specifically, after the outer covering cloth 100 has a certain elasticity in the radial direction, the cylindrical outer covering cloth 100 can be stretched to the outer diameter of the valve stent 200 by elasticity, so that the outer covering cloth 100 can cover the valve stent 200. In this way, the valve stent 200 can adapt to the shape of the outer contour surface of different types of valve stents 200, so that the outer covering cloth 100 can better fit the outer surface shape of the valve stent 200. Moreover, the outer covering cloth 100 can automatically adapt to the deformation of the valve stent 200 under the cardiac cycle after implantation, and the fit will not be affected by the movement of the valve stent 200.

[0050] In one embodiment, the radial elastic elongation of the outer covering cloth 100 is ≥ 340%. The radial elastic elongation refers to the ratio of the length of the outer covering cloth 100 when it is stretched to the limit state in the radial direction and no plastic deformation occurs to the length of the outer covering cloth 100 in the natural state. When the radial elastic elongation of the outer covering cloth 100 is within the above range, the outer covering cloth 100 can have good radial elastic performance.

[0051] In this way, when the outer covering cloth 100 covers the valve stent 200, the outer covering cloth 100 can better fit the outer surface contour of the valve stent 200, avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, and further avoid the occurrence of thrombus, thereby ensuring safety during use. In addition, the outer covering cloth 100 can adapt to the deformation of the valve stent 200, prevent the formation of a gap between the outer covering cloth 100 and the valve stent 200 due to the deformation of the valve stent 200, and further avoid the outer covering cloth 100 from becoming loose, thereby ensuring the connection strength between the valve stent 200 and the outer covering cloth 100, and avoiding failure of the heart valve prosthesis structure.

[0052] See also Figure 1 and Figure 2In one embodiment, the outer covering cloth 100 includes a first covering portion 120, a second covering portion 130 and a third covering portion 140, wherein the second covering portion 130 connects the first covering portion 120 and the third covering portion 140, and the second covering portion 130 has the cutting hole 110. After the outer covering cloth 100 is folded, the second covering portion 130 covers the petal angle 220, the first covering portion 120 covers the outer surface of the petal seat 210, and the third covering portion 140 covers the inner surface of the petal seat 210.

[0053] After the cutting holes 110 are cut out on the outer covering cloth 100, the outer covering cloth 100 forms three regions, namely the first covering portion 120, the second covering portion 130 and the third covering portion 140, and the second covering portion 130 connects the first covering portion 120 and the third covering portion 140. The second covering portion 130 can be divided into a plurality of long strips, and the number of the second covering portions 130 is three, corresponding to the number of the cutting holes 110. Of course, in other embodiments of the present application, the number of the second covering portions 130 can also be two or more, so that the outer covering cloth 100 covers the valve stent 200.

[0054] The second long-strip covering portion 130 is used to cover the petal angle 220. After the outer covering cloth 100 is folded, the second covering portion 130 is symmetrically located on the inner and outer sides of the petal angle 220, while the first covering portion 120 is located on the outer side of the valve stent 200, and the third covering portion 140 is located on the inner side of the valve stent 200. In this way, the second covering portion 130 can cover the petal angle 220 on the inner and outer sides, the first covering portion 120 covers the outer surface of the valve seat 210 on the outer side, and the third covering portion 140 covers the inner surface of the valve seat 210 on the inner side. The edge of the second covering portion 130 is sutured with the first covering portion 120 and the third covering portion 140 in the direction of the outflow channel, that is, the edge of the cutting hole 110 is sutured, and then the first covering portion 120 and the third covering portion 140 are sutured in the direction of the outflow channel, so that the outer covering cloth 100 covers the valve stent 200.

[0055] Optionally, among the three cutting holes 110, two of the cutting holes 110 are completely arranged on the outer covering cloth 100, and the other cutting hole 110 is arranged in two parts at the axial opening of the outer covering cloth 100. In other words, the other cutting hole 110 includes a first part hole and a second part hole, the first part hole is arranged on one side of the axial opening, and the second part hole is arranged on the other side of the axial opening. After the outer covering cloth 100 covers the valve stent 200, the first part hole and the second part hole are matched to form a complete cutting hole 110. At this time, the cutting hole 110 can be directly sutured to reduce the number of suture edges.

[0056] When the outer covering cloth 100 of the present application covers the valve stent 200 and is sutured, the edge of the cutting hole 110 is sutured, and the inner layer edge and the outer layer edge of the outer covering cloth 100 are sutured in the outflow direction. In other words, the outer covering cloth 100 of the present application has four suture edges after suture. Compared with the current outer covering cloth 100 that needs six suture edges, the present application greatly simplifies the suture process, shortens the production suture time, and at the same time, enhances the connection strength.

[0057] Of course, in other embodiments of the present application, the three cutting holes 110 are completely set in the outer covering cloth 100. That is to say, after the cylindrical outer covering cloth 100 is unfolded to form a sheet-like structure, the three cutting holes 110 are a complete structure. At this time, one of the second covering parts 130 is axially broken to form an axial opening. When the outer covering cloth 100 is covered on the valve stent 200, the second covering part 130 is sutured at the axial break, and the outer covering cloth 100 can be sutured and fixed to the valve stent 200.

[0058] See also Figure 1 and Figure 2 In one embodiment, the first covering portion 120, the second covering portion 130 and the third covering portion 140 are an integrated structure. That is, the first covering portion 120, the second covering portion 130 and the third covering portion 140 are made of one piece of cloth. This can reduce the number of sewing edges, simplify the sewing process, shorten the sewing time, and ensure the structural strength of the outer covering cloth 100.

[0059] In one embodiment, the axial length of the second covering portion 130 is less than or equal to twice the axial length of the petal angle 220. In other words, half of the axial length of the second covering portion 130 is less than or equal to the axial length of the petal angle 220. In this way, when the outer covering cloth 100 is folded to cover the valve stent 200, the second covering portion 130 can be folded from the middle so that the second covering portion 130 is located on both sides of the petal angle 220, so as to cover the petal angle 220.

[0060] See also Figure 1 and Figure 2 In one embodiment, the second covering portion 130 includes a covering section 131 and a transition section 132. Both ends of the covering section 131 are connected to the transition section 132, and the first covering portion 120 and the third covering portion 140 are connected through the transition section 132. The covering section 131 is arranged in a long strip shape, and the transition section 132 is located on both sides of the covering section 131. Figure 1As shown, the left and right sides of the covering section 131 are transition sections 132, and the covering section 131 is connected to the first covering portion 120 and the third covering portion 140 through the transition sections 132 on both sides. The transition section 132 can transitionally connect the first covering portion 120 and the third covering portion 140 to cover the arc transition portion of the petal angle 220 and the petal seat 210.

[0061] When the outer covering cloth 100 is folded, the middle area of ​​the covering section 131 is folded, and the petal angle 220 is covered from the direction of the inflow section, and the third covering part 140 is located on the inner side of the petal seat 210, and the first covering part 120 is located on the outer side of the petal seat 210, and the arc transition part between the petal angle 220 and the petal seat 210 is covered by the transition section 132. In this way, the outer covering cloth 100 can accurately fit the shape of the valve stent 200, prevent the gap between the outer covering cloth 100 and the valve stent 200 due to the deformation of the valve stent 200, and thus avoid the outer covering cloth 100 from becoming loose, so as to ensure the connection strength between the valve stent 200 and the outer covering cloth 100, and avoid the failure of the heart valve prosthesis structure. Moreover, since the outer covering cloth 100 accurately fits the valve stent 200, it can avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, thereby avoiding the occurrence of thrombus and ensuring safety during use.

[0062] In one embodiment, the side surface of the transition section 132 has an arc-shaped edge. That is, the transition section 132 is in a shape similar to a trapezoid, and the two oblique sides of the trapezoid are arc-shaped edges. In this way, the arc-shaped surface can achieve a transitional connection between the transition section 132 and the first covering portion 120 or the third covering portion 140, and at the same time, can also cover the arc portion of the valve seat 210. In this way, after the outer covering cloth 100 covers the valve stent 200, the design of the transition section 132 can better fit the arc portion of the connection between the valve seat 210 and the valve angle 220, thereby avoiding the existence of a cavity between the valve stent 200 and the outer covering cloth 100, thereby avoiding the occurrence of thrombus and ensuring safety during use.

[0063] In one embodiment, the covering section 131 includes a first section 1311 and a second section 1312, the first section 1311 and the second section 1312 are connected at one end, and the other ends of the first section 1311 and the second section 1312 are respectively connected to the corresponding transition section 132. After the outer covering cloth 100 is folded in the middle area, the first section 1311 is located on the outside of the petal angle 220, and the second section 1312 is located on the inside of the petal angle 220. After the covering section 131 and the transition section 132 are sewn on the inside and outside, the petal angle 220 can be covered.

[0064] like Figure 2As shown, in one embodiment, the width dimension D of the coating section 131 is ≥ 4 mm. When the width dimension D of the coating section 131 is within the above range, the coating section 131 can accurately cover the petal angle 220 under the action of radial elasticity, thereby achieving accurate fitting of the petal angle 220, avoiding the presence of a gap between the petal angle 220 and the coating section 131, thereby avoiding the occurrence of thrombus and ensuring safety during use.

[0065] In one embodiment, the width of the transition section 132 is in the range of 20 mm to 40 mm. When the width of the transition section 132 is within the above range, the transition section 132 can accurately cover the connection between the petal angle 220 and the petal seat 210 under the action of radial elasticity, thereby achieving accurate fitting and avoiding a gap between the connection between the petal angle 220 and the petal seat 210 and the transition section 132.

[0066] In one embodiment, the axial length of the third covering portion 140 is longer than the axial length of the first covering portion 120. In other words, the length of the outer covering cloth 100 on the inner side is longer than the length of the outer covering cloth 100 on the outer side. In this way, when the outer covering cloth 100 is sewed, the edge of the third covering portion 140 can be folded over the edge of the first outer covering cloth 100, so as to hide the suture line and ensure the suture quality.

[0067] In one embodiment, the axial length of the third covering portion 140 differs from the axial length of the first covering portion 120 by 0.5 mm to 2 mm. Figure 1 As shown, the distance from the edge of the cutting hole 110 to the first covering portion 120 is recorded as A, and the distance from the edge of the cutting hole 110 to the third covering portion 140 is recorded as B. Figure 1 As shown, the sizes of A and B limit the position of the cutting hole 110 in the outer covering cloth 100 and also limit the height of the cutting hole 110. B is 0.5 mm to 2 mm longer than A. In this way, when the outer covering cloth 100 is sewn, the edge of the third covering part 140 can be folded over the edge of the first outer covering cloth 100, so as to hide the sewing line and ensure the sewing quality.

[0068] In one embodiment, the edge of the third covering portion 140 wraps the edge of the first covering portion 120 outwardly and is folded at least once, folded 1 mm to 2 mm each time, to form a 1 mm to 2 mm thick reinforcement edge. That is, after the outer covering cloth 100 is folded to cover the valve stent 200, the third covering portion 140 is longer than the first covering portion 120 in the outflow direction, that is, the inner edge of the outer covering cloth 100 is slightly longer. In this way, after the edge of the third covering portion 140 is folded onto the first covering portion 120 to form a reinforcement edge, the connection strength of the outer covering cloth 100 can be increased, the overall strength and durability of the heart valve prosthesis can be improved, and thrombus formation between the outer covering cloth 100 and the valve stent 200 can be prevented.

[0069] Specifically, the third covering portion 140 is folded outwardly onto the first covering portion 120 and folded by 1 mm to 2 mm, folded once to twice, to form a reinforced edge with a thickness of approximately 1 mm to 2 mm, so as to increase the connection strength of the outer covering cloth 100, improve the overall strength and durability of the heart valve prosthesis, and prevent the formation of blood clots between the outer covering cloth 100 and the valve stent 200.

[0070] It is worth noting that the first covering portion 120 and the third covering portion 140 are sewn together in the inflow direction to form a reinforcement edge, and similarly, the second covering portion 130, the first covering portion 120 and the third covering portion 140 form the same reinforcement edge in the outflow direction, which will not be described in detail here. Moreover, the reinforcement edge is sewn and sealed in a straight seam manner.

[0071] In one embodiment, the diameter of the outer covering cloth 100 in a natural state is smaller than the diameter of the smallest end of the valve stent 200. In this way, the outer covering cloth 100 can accurately fit the shape of the valve stent 200 under the action of radial elasticity, preventing the outer covering cloth 100 and the valve stent 200 from being loosened due to deformation of the valve stent 200, thereby ensuring the connection strength between the valve stent 200 and the outer covering cloth 100 and preventing the failure of the heart valve prosthesis structure. Moreover, since the outer covering cloth 100 accurately fits the valve stent 200, it can avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, thereby avoiding the occurrence of thrombus and ensuring safety during use.

[0072] Furthermore, the outer diameter of the valve stent 200 is a, and the diameter of the outer covering cloth 100 in a natural state is b, wherein: The outer diameter of the valve stent 200 refers to the diameter of the circumscribed circle of the valve seat 210. When the diameter of the valve stent 200 and the diameter of the cylindrical outer covering cloth 100 are within the above range, the outer covering cloth 100 can accurately fit the shape of the valve stent 200 and adapt to the deformation of the valve stent 200.

[0073] In one embodiment, the diameter of the outer covering cloth 100 ranges from 18 mm to 26 mm. In other words, the diameter of the cylindrical outer covering cloth 100 ranges from 18 mm to 26 mm. In this way, the outer covering cloth 100 can cover different types of valve stents 200 to meet the needs of different lesions.

[0074] In one embodiment, the angle between two connected braided wires in the outer covering cloth 100 is in the range of 90° to 135°; the porosity of the outer covering cloth 100 is less than 30%. The outer covering cloth 100 is formed by braiding wires, and when the angle of the braided wires is in the above range, combined with the porosity of the outer covering cloth 100, the permeability of the outer covering cloth 100 can be ensured to facilitate blood to pass through, and at the same time, it can also ensure that the heart valve prosthesis has a better therapeutic effect.

[0075] In one embodiment, the axial length C of the outer covering cloth 100 is determined according to the axial height H of the valve stent 200, wherein C≥2H+2. Figure 1 As shown, Figure 1 is a schematic diagram of the outer covering cloth 100 viewed from an angle, and the axial length of the outer covering cloth 100 is Figure 1 The axial length here refers to the overall length of the cylindrical outer covering cloth 100, at which time the outer covering cloth 100 is not folded. The axial length C of the outer covering cloth 100 is related to the overall height H of the valve stent 200, C ≥ 2H + 2. For the valve stent 200 that currently needs to use the outer covering cloth 100, the aortic valve C is about 25 mm to 60 mm long, and the mitral valve C is about 80 mm to 120 mm long.

[0076] See also Figures 1 to 3 The outer covering cloth 100 of the present application is designed according to the shape of different valve stents 200, so as to ensure that the outer covering cloth 100 better fits the shape of the valve stent 200, prevent the gap between the outer covering cloth 100 and the valve stent 200 caused by the special shape of the valve stent 200, avoid the outer covering cloth 100 from being loose, and ensure the connection strength between the outer covering cloth 100 and the valve stent 200. After the valve stent 200 and the outer covering cloth 100 are fitted, it is possible to avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, thereby avoiding the occurrence of thrombus and ensuring safety during use. Moreover, the outer covering cloth 100 has sufficient radial elasticity, and the cylindrical outer covering cloth 100 can make it better fit the outer surface shape of the valve stent 200, and can adapt to fit cylindrical surfaces, conical surfaces, irregular curved surfaces, etc., and can adapt to the deformation of the valve stent 200 under the cardiac cycle after implantation, and the fit will not be affected by the movement of the valve stent 200.

[0077] In addition, the size of the cutting hole 110 on the outer covering cloth 100 is set according to the shape of the valve stent 200. The shape of the cutting hole 110 can be designed according to the shape of different valve stents 200. At the same time, a reinforcement edge is formed by multiple curling and folding to increase the connection strength. At the same time, it can also improve the overall structural stability of the surgical valve, improve durability, and extend the expected life. The outer covering cloth 100 design can use a piece of covering cloth to completely wrap the entire special-shaped valve stent 200. Compared with the traditional method of wrapping the shape with a flat woven cloth, which requires six suture edges, this design only requires four suture edges, which greatly simplifies the suture process, shortens the production suture working hours, and enhances the suture strength. In addition, the outer covering cloth 100 adopts a circumferentially symmetrical structure, which is convenient for suture positioning during production suture, reduces the difficulty of suture alignment, and simplifies personnel training time.

[0078] See also Figures 1 to 3 The present application also provides a heart valve prosthesis, comprising a valve support 200, a valve frame 300, valve leaflets, and an outer covering cloth 100 as described in any of the above embodiments, wherein the valve frame 300 is arranged on the valve support 200, the valve leaflets are connected to the valve frame 300, and the outer covering cloth 100 covers the valve support 200. After the heart valve prosthesis of the present application uses the above-mentioned outer covering cloth 100 to cover the valve support 200, it can accurately fit the shape of the valve support 200, prevent the gap between the outer covering cloth 100 and the valve support 200 due to the deformation of the valve support 200, and further prevent the outer covering cloth 100 from becoming loose, so as to ensure the connection strength between the valve support 200 and the outer covering cloth 100, and avoid failure of the heart valve prosthesis structure. Moreover, since the outer covering cloth 100 accurately fits the valve stent 200, it can avoid the existence of a cavity between the outer covering cloth 100 and the valve stent 200, thereby avoiding the occurrence of thrombus and ensuring safety during use.

[0079] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0080] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. An outer covering cloth, characterized in that: The outer covering cloth is folded into a cylindrical shape, and the outer covering cloth has a plurality of cutting holes, and the plurality of cutting holes are arranged at intervals along the circumferential direction of the outer covering cloth; The outer covering cloth can be sleeved on the valve stent after being folded along the longitudinal axis of the cutting hole, and fits the valve stent.

2. The outer covering cloth according to claim 1, characterized in that: The outer covering cloth has radial elasticity and can be stretched to the outer diameter of the valve stent by elastic extension; The radial elastic elongation of the outer covering cloth is ≥340%.

3. The outer covering cloth according to claim 1, characterized in that: The outer covering cloth comprises a first covering part, a second covering part and a third covering part, the second covering part connects the first covering part and the third covering part, and the second covering part has the cutting hole; After the outer covering cloth is folded, the second covering portion covers the petal corner, the first covering portion covers the outer surface of the petal seat, and the third covering portion covers the inner surface of the petal seat.

4. The outer covering cloth according to claim 3, characterized in that: The first covering portion, the second covering portion and the third covering portion are an integral structure.

5. The outer covering cloth according to claim 3, characterized in that: The axial length of the second covering portion is less than or equal to twice the axial length of the petal angle.

6. The outer covering cloth according to claim 3, characterized in that: The second covering portion includes a covering section and a transition section, two ends of the covering section are respectively connected to the transition section, and the first covering portion and the third covering portion are connected via the transition section; The side surface of the transition section has an arc-shaped edge.

7. The outer covering cloth according to claim 6, characterized in that: The width of the coating section is ≥4mm; The width of the transition section ranges from 20 mm to 40 mm.

8. The outer covering cloth according to any one of claims 3 to 7, characterized in that: An axial length of the third covering portion is longer than an axial length of the first covering portion.

9. The outer covering cloth according to claim 8, characterized in that: The axial length of the third covering portion differs from the axial length of the first covering portion by 0.5 mm to 2 mm.

10. The outer covering cloth according to claim 8, characterized in that: The edge of the third covering part wraps the edge of the first covering part outwardly and is folded at least once, with each folding being 1 mm to 2 mm, to form a reinforcement edge with a thickness of 1 mm to 2 mm.

11. The outer covering cloth according to any one of claims 1 to 7, characterized in that: The diameter of the outer covering cloth in a natural state is smaller than the diameter of the smallest end of the valve stent; The outer diameter of the valve stent is a, and the diameter of the outer covering cloth in a natural state is b, wherein:

12. The outer covering cloth according to any one of claims 1 to 7, characterized in that: The diameter of the outer covering cloth ranges from 18 mm to 26 mm; The angle between two connected braided wires in the outer covering fabric ranges from 90° to 135°; The porosity of the outer covering cloth is less than 30%.

13. The outer covering cloth according to any one of claims 1 to 7, characterized in that: The axial length C of the outer covering cloth is determined according to the axial height H of the valve stent, wherein C≥2H+2.

14. A heart valve prosthesis, characterized in that: It comprises a valve stent, a valve frame, valve leaflets and an outer covering cloth as described in any one of claims 1 to 13, wherein the valve frame is arranged on the valve stent, the valve leaflets are connected to the valve frame, and the outer covering cloth covers the valve stent.

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