A surgical venous valve

Abstract

The present application provides a surgical venous valve, comprising a stent, a leaflet, and a sealing membrane; the stent can be supported and positioned in a venous vessel; the leaflet is curved and has two edges, namely a suture edge and a free edge, the suture edge and the corresponding suture edge on the sealing membrane are sutured to the stent together, and the sealing membrane can be tightly attached to the inner wall of the venous vessel under the support of the stent; the leaflet has an inner concave side and an outer convex side, and the leaflet can drive the free edge to press against the inner wall of the venous vessel when the pressure on the inner concave side is greater than the pressure on the outer convex side, and the sealing membrane and the free edge are jointly pressed against the inner wall of the venous vessel; the leaflet can drive the free edge to separate from the inner wall of the venous vessel when the pressure on the inner concave side is less than the pressure on the outer convex side. The surgical venous valve of the present application can be inserted into or implanted in human venous vessels to replace the native venous valve, thereby achieving the purpose of treating venous reflux.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and more specifically, relates to a surgical venous valve. Background Art

[0002] Chronic venous disease (CVD) often occurs in the lower limbs. It is a disease caused by the destruction of venous valves, which leads to venous blood reflux and venous hypertension.

[0003] There are three types of blood vessels in the human body: veins, arteries, and capillaries. Only veins have valves. Veins are responsible for carrying blood from all parts of the body back to the heart. To prevent blood from flowing back into the veins, they have valves. When blood flows toward the heart, the valves open, allowing blood to flow toward the heart. Once the blood flows away, the valves close. In summary, venous valves are the "one-way valves" that ensure the veins transport blood back to the heart. Damage to the venous valves can cause venous blood to flow back, leading to venous hypertension and, in turn, CVD.

[0004] Sustained venous hypertension in CVD patients can trigger the extravasation of inflammatory cells and factors within the blood vessels, leading to local inflammation and skin nutritional disorders. Clinical manifestations include superficial varicose veins, tissue edema, and venous ulcer formation.

[0005] Currently, there are two types of treatments for CVD: surgical and non-surgical.

[0006] Treatment options include: Compression stockings, which are elastic stockings designed to squeeze the veins and prevent excessive backflow, and patients need to wear them for life; Sclerotherapy, in which chemicals are injected into the malfunctioning veins. The chemicals damage the abnormal veins, forcing blood to take an alternative, normal venous route, where it is then absorbed by the body; Medication, which can treat some skin problems caused by CVD with anti-inflammatory drugs and control high venous blood pressure with diuretics, but medications do not address the underlying cause of CVD; Surgical ablation, which, like sclerotherapy, destroys the veins from the inside, but uses a catheter with electrodes instead of chemicals; Bypass surgery, in patients with extensive valve damage, surgeons connect an artificial or grafted vein to a healthy vein, bypassing the damaged area. This procedure is often used in more severe cases; Valve repair, in which surgeons typically shorten the valve flap to improve valve function. A sleeve is often placed over the newly fixed vein to help press the vein walls together, preserving the valve's function.

[0007] Conventional treatments fail to fundamentally address the problems of venous valve dysfunction and venous reflux, and suffer from drawbacks such as high recurrence rates and low ulcer healing rates. Furthermore, surgical procedures such as ablation and bypass surgery are associated with lengthy procedures, high operational difficulty, significant trauma, and a high risk of postoperative venous thrombosis. To prevent deep vein thrombosis, large amounts of anticoagulants are often required during and after surgery, potentially leading to complications such as hematoma and bleeding. Summary of the Invention

[0008] The purpose of the embodiments of the present application is to provide a surgical venous valve to solve the technical problems of venous valve function loss and venous reflux that the traditional treatment methods in the prior art do not fundamentally solve.

[0009] To achieve the above-mentioned purpose, the technical solution adopted in the present application is: to provide a surgical venous valve, including a stent, a leaflet and a sealing membrane; the stent can be supported and positioned in a venous blood vessel; the leaflet is curved and has two edges, which are a suture edge and a free edge, and the suture edge is sutured to the stent together with the position corresponding to the suture edge on the sealing membrane, and the sealing membrane can be tightly attached to the inner wall of the venous blood vessel under the support of the stent; the leaflet has an inner concave side and an outer convex side, and the leaflet can drive the free edge to press against the inner wall of the venous blood vessel when the pressure on the inner concave side is greater than the pressure on the outer convex side, and the sealing membrane and the free edge are jointly pressed against the inner wall of the venous blood vessel; the leaflet can drive the free edge to separate from the inner wall of the venous blood vessel when the pressure on the inner concave side is less than the pressure on the outer convex side.

[0010] In a possible design, the stitching edge and the free edge are arranged on the same cylindrical surface.

[0011] In a possible design, the free edges are provided at the same axial position of the stent, and the free edges are scanned and extended along a scanning line to the suture edge;

[0012] The free edge is an elliptical curve, a circular arc, a hyperbola and a spline curve;

[0013] The scanning line is an elliptic curve, a circular arc, a hyperbola and a spline curve.

[0014] In a possible design, the arc length of the free edge along the circumference of the bracket is equal to the arc length of the sealing film along the circumference of the bracket, and opposite ends of the free edge are respectively connected to the sealing film.

[0015] In one possible design, the valve leaflet is made of bovine pericardium, porcine pericardium or porcine heart valve;

[0016] The sealing membrane is made of bovine pericardium, porcine pericardium or polymer membrane.

[0017] In a possible design, the bracket is made of stainless steel, cobalt-chromium alloy or polymer material.

[0018] In a possible design, the bracket includes two mounting rings, two mounting beams and a suture beam; the two mounting rings are oppositely and spaced apart in the axial direction of the bracket, and the two mounting beams are respectively connected between the two mounting rings; the opposite ends of the sealing membrane in the axial direction are respectively sewn to the two mounting rings, and the opposite ends of the sealing membrane in the circumferential direction are respectively sewn to the two mounting beams; the opposite ends of the suture beam are respectively connected to the two mounting beams, and the suture edges and the sealing membrane corresponding to the positions of the suture edges are sewn together on the suture beam.

[0019] In one possible design, the bracket also includes at least one support beam, the two ends of the support beam are respectively connected to the two mounting rings, the support beam is located between the two mounting beams, the support beam is cross-connected with the suture beam, and the support beam is used to sew and support the sealing membrane at a position between the two mounting beams.

[0020] In a possible design, the bracket includes a support beam, which is located in the middle position between the two mounting beams along the circumferential direction, and the support beam is integrally connected to the suture beam.

[0021] In a possible design, the portion of the support beam facing the leaflet and located between the suture beam and the corresponding mounting ring is arranged in an outwardly convex arc shape.

[0022] The beneficial effects of the surgical venous valve provided by the present application are as follows: the surgical venous valve provided by the embodiment of the present application, through the setting of the stent, makes it possible to insert and position the surgical venous valve in the venous blood vessel, and at the same time, the valve leaflets and the sealing membrane can be sutured and supported by the stent; the suture edge and the position on the sealing membrane corresponding to the suture edge are sutured together on the stent, so that the sealing membrane and the valve leaflets are sealed; in addition, the sealing membrane can be tightly attached to the inner wall of the venous blood vessel under the support of the stent, and the valve leaflet can drive the free edge to press against the inner wall of the venous blood vessel when the pressure on the concave side is greater than the pressure on the convex side, and the sealing membrane and the free edge are pressed against the inner side of the venous blood vessel together, and the valve leaflet can press against the inner wall of the venous blood vessel when the pressure on the concave side is less than the pressure on the convex side. The arrangement drives the free edge to separate from the inner wall of the vein when pressure is applied, so that when the surgical venous valve is inserted into the vein with the concave side of the leaflet facing the heart, when blood from various parts of the body needs to flow into the surgical venous valve, the pressure on the convex side of the leaflet is greater than the pressure on the concave side, so that the leaflet drives the free edge to separate from the inner wall of the vein to increase the gap for blood flow; after the blood flows away, the pressure on the concave side of the leaflet is greater than the pressure on the convex side, so that the leaflet drives the free edge to adhere to the inner wall of the vein, and the sealing membrane is always pressed against the inner wall of the vein, so that the free edge and the sealing membrane are pressed against the inner wall of the vein together, thereby preventing blood from flowing back into the vein, and thus fundamentally treating the problem of venous reflux. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0024] Figure 1 A three-dimensional schematic diagram of a surgical venous valve provided in an embodiment of the present application;

[0025] Figure 2 for Figure 1 Schematic diagram of the side view of the middle surgical venous valve after the suture line is added;

[0026] Figure 3 for Figure 2 A side view of the middle surgical venous valve from another angle;

[0027] Figure 4 for Figure 2 Schematic diagram of the open valve leaflet after the surgical venous valve is inserted into the venous blood vessel;

[0028] Figure 5 for Figure 2Schematic diagram of the closed state of the valve leaflets after the Chinese surgical venous valve is inserted into the venous blood vessels;

[0029] Figure 6 for Figure 2 Schematic diagram of the suturing of the middle sealing membrane and the leaflet;

[0030] Figure 7 for Figure 2 Schematic diagram of the middle leaflet;

[0031] Figure 8 for Figure 2 Schematic side view of the middle leaflet;

[0032] Figure 9 for Figure 2 A three-dimensional schematic diagram of the middle bracket;

[0033] Figure 10 for Figure 2 A schematic diagram of the structure of a support beam of a surgical venous valve having an outer convex portion;

[0034] Figure 11 for Figure 10 Schematic diagram of the blood bypass formed by the middle valve leaflet and the sealing membrane.

[0035] Among them, the reference numerals in the figures are:

[0036] 100. Bracket; 110. Mounting ring; 120. Mounting beam; 130. Suturing beam; 140. Support beam; 141. Outer protrusion; 150. First end; 160. Second end; 200. Leaflet; 210. Suturing edge; 220. Free edge; 230. Concave side; 240. Convex side; 250. Scan line; 300. Sealing membrane; 400. Vein; 500. Suture. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and beneficial effects to be solved by this application more clearly understood, this application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0038] It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or indirectly connected to the other element.

[0039] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0040] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0041] See also Figures 1 to 5 The surgical venous valve provided in the embodiment of the present application is now described. The surgical venous valve is used for intervention or implantation in human veins to replace the native venous valve, thereby achieving the purpose of treating venous reflux.

[0042] The surgical venous valve comprises a stent 100 , leaflets 200 and a sealing membrane 300 . The stent 100 can be supported and positioned in a venous vessel 400 , and the sealing membrane 300 and leaflets 200 are both sutured and mounted on the stent 100 by suture threads 500 .

[0043] See also Figures 1 to 7 The leaflet 200 is curved and has two edges, namely a suture edge 210 and a free edge 220 ; specifically, the suture edge 210 and the free edge 220 are both curves, and the opposite ends of the suture edge 210 are respectively connected to the opposite ends of the free edge 220 . The suture edge 210 is sutured to the stent 100 together with the position of the sealing film 300 corresponding to the suture edge 210. The sealing film 300 can be tightly attached to the inner wall of the vein 400 under the support of the stent 100. The valve leaflet 200 has an inner concave side 230 and an outer convex side 240 arranged opposite to each other. When the pressure on the inner concave side 230 is greater than the pressure on the outer convex side 240, the valve leaflet 200 can drive the free edge 220 to press against the inner wall of the vein 400. At this time, the sealing film 300 and the free edge 220 of the valve leaflet 200 are jointly pressed against the inner wall of the vein 400 to close the surgical venous valve and prevent blood from flowing between the surgical venous valve and the inner wall of the vein 400. When the pressure on the inner concave side 230 is less than the pressure on the outer convex side 240, the valve leaflet 200 can drive the free edge 220 to separate from the inner wall of the vein 400 to open the surgical venous valve and allow blood to flow between the valve leaflet 200 and the inner wall of the vein 400.

[0044] The stent 100 can be inserted into and supported by the vein 400 to be positioned therein. The stent 100 is generally cylindrical in shape, so that the stent 100 can conform to the inner wall of the vein 400 without scratching the vein 400. It is understood that in actual design, the outer wall of the stent 100 can also be configured as a partially convex curved surface to facilitate positioning within the vein 400 or other functions.

[0045] See also Figure 3 and Figure 4 The stent 100 has a first end 150 and a second end 160 that are relatively arranged, wherein the first end 150 is defined as the end of the stent 100 facing the heart after being installed in the vein 400, and the second end 160 is the end of the stent 100 away from the heart.

[0046] See also Figure 3 and Figure 4 The leaflet 200 is curved, and has an inner concave side 230 and an outer convex side 240. In combination with the function of the venous valve, it can be seen that the venous valve is a "one-way valve" that ensures that the vein transports blood back to the heart. The venous valve is used to open to allow blood to flow to the heart, and close after the blood flows away to prevent blood from flowing back into the vein 400. Figure 3 and Figure 4 It can be seen that the concave side 230 of the leaflet 200 refers to the side facing the first end 150, and the convex side 240 of the leaflet 200 refers to the side facing the second end 160. When blood from various parts of the body needs to be transported back to the heart, the pressure P2 on the convex side 240 is greater than the pressure P1 on the concave side 230. The leaflet 200 drives the free edge 220 away from the inner wall of the vein 400, forming a gap between the leaflet 200 and the vein 400, thereby transporting blood from various parts of the body back to the heart. After the blood flows away, the pressure P1 on the concave side 230 of the leaflet 200 is greater than the pressure P2 on the convex side 240. The leaflet 200 drives the free edge 220 to adhere to the inner wall of the vein 400. In addition, the sealing membrane 300 is always pressed against the inner wall of the vein 400. The free edge 220 and the sealing membrane 300 are jointly pressed against the inner wall of the vein 400, thereby preventing blood from flowing back into the vein 400.

[0047] In addition, it should be noted that the position on the sealing film 300 corresponding to the suture edge 210 is sutured to the stent 100 together with the suture edge 210, indicating that the sealing film 300 and the valve leaflets 200 are in a sealed connection. Under the support of the stent 100, the sealing film 300 can abut against the inner wall of the venous vessel 400, that is, the sealing film 300 and the inner wall of the venous vessel 400 are always in a sealed connection. When the free edge 220 of the valve leaflet 200 abuts against the inner wall of the venous vessel 400, the sealing film 300 and the free edge 220 jointly abut against the inner wall of the venous vessel 400. Specifically, the sealing film 300 abuts against a first portion of the circumferential inner wall of the venous vessel 400, and the free edge 220 of the valve leaflet 200 abuts against a second portion of the circumferential inner wall of the venous vessel 400. The first portion of the circumferential inner wall and the second portion of the circumferential inner wall are connected circumferentially and axially, thereby achieving a sealed connection between the venous valve and the venous vessel 400. Sealed connection; in other words, for the entire surgical venous valve, its peripheral seal is composed of the sealing membrane 300 and the leaflets 200, and the sealing membrane 300 is always in contact with the inner wall of the vein 400. Therefore, when the free edge 220 of the leaflet 200 is in contact with the inner wall of the vein 400, the surgical venous valve and the vein 400 are sealed; when the free edge 220 of the leaflet 200 is separated from the inner wall of the vein 400, blood can flow between the leaflet 200 and the vein 400.

[0048] The surgical venous valve in this embodiment can be inserted and positioned in the vein 400 by the provision of the stent 100, and the stent 100 can also be used to suture and support the leaflets 200 and the sealing membrane 300; by suturing the suture edge 210 and the position corresponding to the suture edge 210 on the sealing membrane 300 to the stent 100, a sealed connection is achieved between the sealing membrane 300 and the leaflets 200; in addition, the sealing membrane 300 can be tightly attached to the inner wall of the vein 400 under the support of the stent 100, and the leaflets 200 can drive the free edge 220 to press against the inner wall of the vein 400 when the pressure on the inner concave side 230 is greater than the pressure on the outer convex side 240, and the sealing membrane 300 and the free edge 220 can be pressed against the inner side of the vein 400 together, and the leaflets 200 can drive the free edge 220 to press against the inner wall of the vein 400 when the pressure on the inner concave side 230 is less than the pressure on the outer convex side 240. The arrangement of the leaflet 200 detaching from the inner wall of the vein 400 allows, when the surgical venous valve is inserted into the vein 400 with the concave side 230 of the leaflet 200 facing the heart, when blood from various parts of the body needs to flow into the surgical venous valve, the pressure on the convex side 240 of the leaflet 200 is greater than the pressure on the concave side 230, causing the leaflet 200 to drive the free edge 220 away from the inner wall of the vein 400, thereby increasing the gap for blood flow; after the blood flows away, the pressure on the concave side 230 of the leaflet 200 is greater than the pressure on the convex side 240, causing the leaflet 200 to drive the free edge 220 to adhere closely to the inner wall of the vein 400. In addition, the sealing membrane 300 is always pressed against the inner wall of the vein 400, and the free edge 220 and the sealing membrane 300 are pressed against the inner wall of the vein 400 together, thereby preventing blood from flowing back into the vein 400, thereby fundamentally treating the problem of venous reflux.

[0049] Optionally, the leaflet 200 can be made of bovine pericardium, porcine pericardium or porcine heart valve, so that the manufactured leaflet 200 has good elasticity and toughness, can match the human leaflet 200, and is suitable for surgical venous valves.

[0050] Optionally, the sealing membrane 300 can be made of bovine pericardium, porcine pericardium or polymer membrane. The sealing membrane 300 not only needs to have good flexibility, but is also used to prevent perivalvular reflux after valve implantation. At the same time, the sealing membrane 300 can also promote tissue proliferation and enable the valve and blood vessels to fuse in a short period of time.

[0051] The sealing film 300 can be installed on the inner side of the stent 100 or on the outer side of the stent 100. When the sealing film 300 is installed on the inner side of the stent 100, the sealing film 300 and the leaflets 200 are more closely attached, thereby achieving a better sealing effect between the sealing film 300 and the leaflets 200; when the sealing film 300 is installed on the outer side of the stent 100, the sealing film 300 and the leaflets 200 are sutured to the inner and outer sides of the stent 100 respectively, thereby making the suturing of the sealing film 300 and the leaflets 200 more convenient and achieving a better suturing effect, and also allowing the sealing film 300 to better integrate with the vein 400.

[0052] In one embodiment, the suture edge 210 and the free edge 220 are disposed on the same cylindrical surface; the diameter of the circular surface is configured to match the diameter of the vein 400. This configuration allows, in the initial installation state, the perimeter of the valve leaflet 200 to abut against the inner wall of the vein 400. The sealing membrane 300 is sewn together with the suture edge 210 at a position corresponding to the suture edge 210, thereby allowing the sealing membrane 300 to abut against the inner wall of the vein 400. Furthermore, the position of the sealing membrane 300 corresponding to the suture edge 210 and the free edge 220 can abut against the inner wall of the vein 400. In this case, the sealing membrane 300 can be extended entirely along the axial direction of the circular surface, with the circumferential length of the sealing membrane 300 at least covering the circumferential length of the suture edge 210, to achieve sealing of the surgical venous valve through the sealing membrane 300 and the valve leaflet 200. It can be understood that in other embodiments of the present application, the suture edge 210 and the free edge 220 may not be arranged on the same cylindrical surface, but on the same closed curved surface. In this case, a support structure can be provided on the bracket 100 to stretch the position of the sealing film 300 that is not sutured with the suture edge 210 outward so that the sealing film 300 can abut against the inner wall of the vein 400.

[0053] The cylindrical surface is a virtual surface. When the bracket 100 is cylindrical, the cylindrical surface is the inner side surface of the bracket 100 .

[0054] In one embodiment, see Figure 2 、 Figure 7 and Figure 8 The free edge 220 is provided at the same axial position of the stent 100, and the free edge 220 is scanned and extended along a scanning line 250 to the suture edge 210. In other words, the suture edge 210 is formed by the free edge 220 scanning and extending along the scanning line 250 to the inner side surface (cylindrical surface) of the stent 100, and the free edge 220 itself is on the cylindrical surface of the stent 100, so that the free edge 220 and the suture edge 210 can be provided on the same cylindrical surface.

[0055] In addition, the free edge 220 is arranged at the same axial position of the stent 100, so that any position along the free edge 220 is at the same axial height. When the free edge 220 is squeezed by pressure, any position on the free edge 220 abuts the inner wall of the vein 400 to the same degree, thereby facilitating control.

[0056] Preferably, the free edge 220 is an arc line, so that the free edge 220 can be aligned with the vein 400. It is understandable that in other embodiments of the present application, the free edge 220 can also be an elliptical curve, a hyperbola, or a spline curve.

[0057] Optionally, the scan line 250 may be an elliptical curve, a circular arc, a hyperbola, or a spline curve.

[0058] In one embodiment, see Figure 4 The arc length of the free edge 220 along the circumference of the stent 100 is equal to the arc length of the sealing membrane 300 along the circumference of the stent 100, and the opposite ends of the free edge 220 are respectively connected to the sealing membrane 300. That is, the free edge 220 is semicircular in shape, the sealing membrane 300 is semi-cylindrical in shape, and the opposite ends of the free edge 220 are respectively connected to the opposite ends of the sealing membrane 300 along the circumference. This arrangement enables the sealing membrane 300 to abut against half of the inner wall of the venous vessel 400 along the circumference, and the leaflets 200 to abut against the other inner wall of the venous vessel 400 along the circumference. It is understood that in other embodiments of the present application, when the free edge 220 is semicircular in shape, the arc length of the sealing membrane 300 along the circumference can also be greater than the arc length of the free edge 220, that is, the opposite ends of the sealing membrane 300 along the circumference overlap with the free edge 220, thereby improving the sealing effect of the surgical venous valve. In addition, in other embodiments of the present application, the arc length of the free edge 220 along the circumferential direction may also be less than half an arc or greater than half an arc, which is not the only limitation here.

[0059] In one embodiment, see Figure 2 、 Figure 3 and Figure 9The length of the sealing membrane 300 along the axial direction of the stent 100 is greater than the length of the leaflet 200 along the axial direction of the stent 100; the stent 100 includes two mounting rings 110, two mounting beams 120 and a suture beam 130; the two mounting rings 110 are opposite and spaced apart along the axial direction of the stent 100, and the two mounting beams 120 are respectively connected between the two mounting rings 110, and the opposite ends of the sealing membrane 300 along the axial direction are respectively sutured to the two mounting rings 110 through sutures 500, and the opposite ends of the sealing membrane 300 along the circumferential direction are respectively sutured to the two mounting beams 120 through sutures 500; the opposite ends of the suture beam 130 are respectively connected to the two mounting beams 120, and the suture edge 210 and the position of the sealing membrane 300 corresponding to the suture edge 210 are sutured together on the suture beam 130 through sutures 500.

[0060] The outer diameters of the two mounting rings 110 are configured to match the inner diameter of the vein 400. The two mounting rings 110, the two mounting beams 120, and the suture beam 130 connect to form a cylindrical stent 100, enabling the stent 100 to be supported and positioned within the vein 400. Simultaneously, the two mounting rings 110, the two mounting beams 120, and the suture beam 130 prop up the sealing membrane 300 into a semi-cylindrical shape, not only ensuring a sealed connection between the sealing membrane 300 and the leaflets 200 but also allowing the outer wall of the sealing membrane 300, supported by the stent 100, to cling tightly to half of the inner wall of the vein 400. Furthermore, the design of the two mounting rings 110 ensures sufficient support rigidity for the stent 100, preventing the surgical venous valve from collapsing after implantation.

[0061] The setting of the suture beam 130, the shape and size of the suture beam 130 are consistent with the suture edge 210, which tightly sutures the suture edge 210 of the leaflet 200 and the sealing membrane 300 together, thereby realizing a sealed connection between the sealing membrane 300 and the leaflet 200; at the same time, the setting of the suture beam 130 also makes it possible to suture the leaflet 200 along the suture beam 130, which is simple to operate and not prone to errors.

[0062] In actual operation, the sealing membrane 300 can be positioned first by two mounting rings 110 and two mounting beams 120, and then the two ends of the sealing membrane 300 along the axial direction are sutured and positioned on the two mounting rings 110, and the two ends of the sealing membrane 300 along the circumferential direction are sutured and positioned on the two mounting beams 120 respectively; finally, the suture edge 210 of the leaflet 200 and the position on the corresponding suture beam 130 on the sealing membrane 300 are sutured together on the suture beam 130, thereby completing the assembly of the entire surgical venous valve.

[0063] In addition, the present application makes the axial length of the sealing membrane 300 along the stent 100 greater than the axial length of the leaflet 200 along the stent 100 so that both ends of the sealing membrane 300 along the axial direction can be stably positioned on the two mounting rings 110 .

[0064] In one embodiment, see Figure 2 、 Figure 3 and Figure 9 The stent 100 further includes at least one support beam 140, the two ends of which are connected to the two mounting rings 110, respectively. The support beam 140 is located between the two mounting beams 120 and cross-connected with the suture beam 130. The support beam 140 is used to sew and support the sealing membrane 300 between the two mounting beams 120. In the present application, since the sealing membrane 300 is relatively long along the circumference of the stent 100 and the sealing membrane 300 itself cannot be shaped, in order to ensure the tension of the sealing membrane 300 and to ensure that the sealing membrane 300 is tightly attached to the vein 400, the support beam 140 is used to support and position the sealing membrane 300 between the two opposite ends along the circumference.

[0065] Preferably, the stent 100 includes a support beam 140, which is located midway between the two mounting beams 120 along the circumferential direction, and is integrally connected to the suture beam 130. The provision of a single support beam 140 in this embodiment not only allows the sealing membrane 300 to be sutured at the midway point along the circumference for positioning and support, but also reduces the overall structure of the stent 100 from being complex, as the number of beams connecting the two mounting rings 110 is small. This allows the stent 100 to have a certain degree of overall flexibility, facilitating insertion of the stent 100 into the vein 400. It is understood that in other embodiments of the present application, the number of support beams 140 may be two, three, or more, and this is not intended to be a single limitation.

[0066] In one embodiment, see Figure 10 and Figure 11 The portion of the support beam 140 facing the leaflet 200 and located between the suture beam 130 and the corresponding mounting ring 110 is configured in an outwardly convex arc shape. The outwardly convex portion of the support beam 140 is referred to as the convex portion 141. The distance between the convex portion 141 and the leaflet 200 gradually increases from zero to the free edge 220, and then gradually decreases. This configuration creates a larger blood flow space between the leaflet 200 and the sealing membrane 300, facilitating blood flow and preventing blood stagnation, which increases the risk of thrombosis. Furthermore, this convex shape creates an oblique contact between the stent 100 and the corresponding position of the vein 400, thereby preventing slippage of the artificial venous valve and achieving effective fixation.

[0067] In one embodiment, the diameter of the stent 100 ranges from 4 mm to 8 mm to accommodate veins 400 of different sizes.

[0068] In one embodiment, the two mounting rings 110, the two mounting beams 120, the stitching beam 130, and the support beam 140 are integrally connected. It is understood that in other embodiments of the present application, the two mounting rings 110, the two mounting beams 120, the stitching beam 130, and the support beam 140 may also be independently manufactured and assembled in sequence, and this is not intended to be a limitation.

[0069] In one embodiment, the stent 100 can be made of stainless steel, cobalt-chromium alloy and polymer materials. These three materials can be inserted into or implanted into the human body without causing any impact on the human body, and at the same time have a certain structural strength and play a supporting role.

[0070] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A surgical venous valve, characterized in that: The invention comprises a stent, a leaflet and a sealing membrane; the stent can be supported and positioned in a venous blood vessel; the leaflet is curved and has two edges, namely a suture edge and a free edge; the suture edge is sutured to the stent together with a position on the sealing membrane corresponding to the suture edge; the sealing membrane can be tightly attached to the inner wall of the venous blood vessel under the support of the stent; the leaflet has an inner concave side and an outer convex side; the leaflet can drive the free edge to press against the inner wall of the venous blood vessel when the pressure on the inner concave side is greater than the pressure on the outer convex side, and the sealing membrane and the free edge are jointly pressed against the inner wall of the venous blood vessel; the leaflet can drive the free edge to separate from the inner wall of the venous blood vessel when the pressure on the inner concave side is less than the pressure on the outer convex side; the sealing membrane abuts against a first part of the circumferential inner wall of the venous blood vessel, and the free edge of the leaflet abuts against a second part of the circumferential inner wall of the venous blood vessel, and the first part of the circumferential inner wall and the second part of the circumferential inner wall are connected along the circumference.

2. The surgical venous valve according to claim 1, wherein The stitching edge and the free edge are arranged on the same cylindrical surface.

3. The surgical venous valve according to claim 1, wherein The free edges are arranged at the same axial position of the stent, and the free edges are scanned and extended along a scanning line to the suture edge; The free edge is an elliptical curve, a circular arc, a hyperbola and a spline curve; The scanning line is an elliptic curve, a circular arc, a hyperbola and a spline curve.

4. The surgical venous valve according to claim 1, wherein The arc length of the free edge along the circumference of the bracket is equal to the arc length of the sealing film along the circumference of the bracket, and opposite ends of the free edge are respectively connected to the sealing film.

5. The surgical venous valve according to claim 1, wherein The valve leaflets are made of bovine pericardium, porcine pericardium or porcine heart valves; The sealing membrane is made of bovine pericardium, porcine pericardium or polymer membrane.

6. The surgical venous valve according to claim 1, wherein The bracket is made of stainless steel, cobalt-chromium alloy or polymer material.

7. The surgical venous valve according to any one of claims 1 to 6, characterized in that: The bracket includes two mounting rings, two mounting beams and a suture beam; the two mounting rings are opposite and spaced apart in the axial direction of the bracket, and the two mounting beams are respectively connected between the two mounting rings; the opposite ends of the sealing membrane in the axial direction are respectively sewn to the two mounting rings, and the opposite ends of the sealing membrane in the circumferential direction are respectively sewn to the two mounting beams; the opposite ends of the suture beam are respectively connected to the two mounting beams, and the suture edges and the sealing membrane corresponding to the positions of the suture edges are sewn together on the suture beam.

8. The surgical venous valve according to claim 7, wherein The bracket also includes at least one support beam, the two ends of which are respectively connected to the two mounting rings, the support beam is located between the two mounting beams, the support beam is cross-connected with the suture beam, and the support beam is used to sew and support the sealing membrane at a position between the two mounting beams.

9. The surgical venous valve according to claim 8, wherein The bracket includes a support beam, which is located in the middle position of the two mounting beams along the circumferential direction, and the support beam is integrally connected with the suture beam.

10. The surgical venous valve according to claim 9, wherein The portion of the support beam facing the leaflet and located between the suture beam and the corresponding mounting ring is arranged in an outwardly convex arc shape.

Images