CN218870588U - Valve leaf mounting structure and artificial venous valve - Google Patents

Abstract

The application provides a valve leaflet mounting structure and a prosthetic venous valve, wherein the valve leaflet mounting structure comprises a valve leaflet structure and a support; the valve leaf structure comprises two valve leaves which are formed by sewing different circumferential positions of the elastic membrane on the bracket respectively; the valve leaf is provided with a movable edge and a sewing edge, the movable edge is positioned on one axial end face of the elastic membrane, the sewing edge extends from one end of the movable edge to the other end of the movable edge along a curve, and the sewing edge is sewn on the support; the two valve leaflets can generate elastic deformation under the action of the pressure of blood flowing along the positive direction and drive the two movable edges to be separated from each other, and the two valve leaflets can generate elastic deformation under the action of the pressure of blood flowing along the reverse direction and drive the two movable edges to be mutually abutted; the arc length of the movable edge is smaller than the diameter of the elastic membrane. The utility model provides a leaflet mounting structure can be applied to in the artificial vein valve to reach the palirrhea purpose of treatment blood, can also improve the life of artificial vein leaflet simultaneously.

Description

Valve leaf mounting structure and artificial venous valve

Technical Field

The application belongs to the technical field of medical equipment, and more particularly relates to a valve leaflet mounting structure and a prosthetic venous valve.

Background

Chronic Venous Disease (CVD) is a disease often occurring in the lower extremities due to venous hypertension caused by venous blood reflux due to the destruction of the venous valves. Relevant data show that the prevalence rate of lower limb venous diseases in China is 8.89%, namely nearly 1 hundred million patients exist.

There are three blood vessels in the human body, veins, arteries and capillaries. Wherein only the vein has a valve, and the vein is responsible for bringing the blood of each part of the body back to the heart, in order to prevent the blood from flowing back to the vein, therefore have the valve in the vein, the valve opens when blood flows to the heart, lets blood flow to the heart, and the valve will close after the blood flows away. In summary, the Venous Valve (Venous Valve) is a "one-way Valve port" that ensures Venous delivery of blood back to the heart, and damage to the Venous Valve can cause Venous blood to flow back, resulting in Venous hypertension and thus CVD.

Continuous venous high pressure in CVD patients causes extravascular migration of inflammatory cells and factors in the blood vessels, resulting in local inflammation and skin dystrophy. The clinical manifestations are superficial varicosity, tissue edema and venous ulcer formation.

There are two types of current treatment for CVD, surgical and non-surgical.

The specific treatment means is as follows: compression stockings, elastic stockings intended to compress the veins and prevent excessive reflux, which the patient needs to wear for life; sclerotherapy, which is the injection of a chemical into a dysfunctional vein that destroys the abnormal vein allowing the blood to take another normal venous path, the destroyed vein being subsequently absorbed by the body; in the drug therapy, anti-inflammatory drugs can be used for curing some skin problems caused by CVD, and diuretics are used for controlling overhigh venous blood pressure, but the drug therapy cannot solve the fundamental problem of CVD; surgical treatment ablation, like sclerotherapy, veins are destroyed from the inside, but instead of chemicals, catheters with electrodes are used in ablation; bypass surgery, for patients with a wide range of valve-damaged areas, the surgeon connects a prosthetic or graft vein to a healthy vein and bypasses the damaged area. This procedure is often used in more severe cases; valvular repair procedures, in which a surgeon typically foreshortens the valve to improve valve function. A sleeve is typically placed outside the newly-secured vein, which helps to press the vein walls together to maintain proper function of the valve.

The conventional traditional treatment method does not fundamentally solve the problems of venous valve function loss and venous reflux, and has the defects of easy relapse, low ulcer healing rate and the like. In addition, the operation modes such as ablation, bypass and the like have the defects of long operation time, higher operation difficulty, large wound, easy venous thrombosis formation after operation and the like. In order to prevent deep vein thrombosis, a large amount of anticoagulant drugs are often applied during and after the operation, which may cause postoperative hematoma, hemorrhage and other complications.

SUMMERY OF THE UTILITY MODEL

An object of the embodiment of the application is to provide a leaflet mounting structure and artificial venous valve to solve the technical problem that the function of venous valve loses and venous regurgitation can not fundamentally be solved to the traditional treatment method who exists among the prior art.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: providing a leaflet mounting structure for use in a prosthetic venous valve, the leaflet mounting structure comprising a leaflet structure and a stent; the valve leaf structure comprises two valve leaves which are formed by sewing different circumferential positions of a cylindrical elastic membrane on the support; the valve leaf is provided with a movable edge and a sewing edge, the movable edge is positioned on one axial end face of the elastic membrane, the sewing edge is positioned on the membrane wall of the elastic membrane, the sewing edge extends from one end of the movable edge to the other end of the movable edge along a curve, and the sewing edge is sewn on the support; the two valve leaflets can elastically deform under the action of the pressure of blood flowing along the positive direction and drive the two movable edges to be separated from each other, and the two valve leaflets can elastically deform under the action of the pressure of the blood flowing along the reverse direction and drive the two movable edges to be abutted against each other; the arc length of the movable edge is smaller than the diameter of the elastic membrane.

In one possible design, a spacer is connected between the two valve leaflets along at least one side in the circumferential direction; the edge of the spacing part, which is positioned on the axial end face where the movable edge is positioned, is a spacing edge, and the spacing edge is connected between the two movable edges; the spacing part is sewn and fixed on the bracket.

In one possible design, the leaflet structure includes two of the spacers connected between two sides of the leaflets; the spacing edges of the two spacing parts and the movable edges of the two valve leaflets jointly form an axial end face of the elastic membrane.

In a possible design, the support is provided with a mounting beam arranged in a closed loop, the mounting beam is attached to the position, close to the spacing edge, of the spacing part, a circle of side wall of the mounting beam is connected with the corresponding position of the spacing part in a sewing mode, and the mounting beam is used for supporting the spacing part.

In one possible design, the mounting beam is circular, square, rectangular, oval, diamond, or irregular closed loop shape.

In one possible design, the leaflet structure includes an axially connected fixation section and a leaflet section, the fixation section is cylindrical, the fixation section is in suture connection with the stent, and the leaflets and the spacers are circumferentially distributed in the leaflet section.

In a possible design, the support is further provided with a plurality of positioning rings, the positioning rings are arranged at intervals along the axial direction and the circumferential direction of the support, and the positioning rings are used for being connected with the spacing parts or the fixing sections in a sewing mode to position the valve leaf structures.

In one possible design, the stent comprises two sewing beams, the different circumferential positions of the elastic membrane corresponding to the sewing edges of the two leaflets to be sewn on the two sewing beams.

In one possible design, the elastic membrane is made of animal pericardium.

The application provides a leaflet mounting structure's beneficial effect lies in: the utility model provides a leaflet mounting structure, through set up the leaflet structure into two leaflets can produce elastic deformation and drive two movable limits and part each other under the blood pressure effect that flows along the positive direction, and can produce elastic deformation and drive two movable limits and support each other tightly under the blood pressure effect that flows along the adverse direction, thereby can realize the one-way flow of blood among the vein, avoid blood reflux phenomenon to appear, fundamentally has solved the palirrhea problem of vein. Meanwhile, the two valve leaflets are formed by sewing different circumferential positions of the cylindrical elastic membrane on the support, so that each valve leaflet is not required to be manufactured by cutting, only the position, required to be sewn, of each valve leaflet is required to be sewn on the support through a sewing thread, and the manufacturing process is simple. In addition, the circular arc length through the activity limit with two leaflet sets up to be less than the diameter of elastic membrane to when making two activity limits butts, two activity limits can be in elasticity and stretch out straight state, also make the whole tensile state that is in of leaflet, have not folding and crooked on the leaflet, guaranteed the life of leaflet in the use, and then improved the life and the blood flow nature stability of the artificial vein valve who uses this leaflet.

In another aspect, the present application also provides a prosthetic venous valve including the leaflet mounting structure described above.

The application provides a vein prosthesis's beneficial effect lies in: the utility model provides a vein prosthesis valve, through the setting of above-mentioned leaflet mounting structure, not only can fundamentally solve the palirrhea problem of vein, can also improve vein prosthesis valve's life and the stability of blood flow ability simultaneously.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.

Fig. 1 is a schematic perspective view of a prosthetic venous valve provided in an embodiment of the present application;

FIG. 2 is a schematic structural diagram of a vein valve prosthesis provided in an embodiment of the present application after the vein valve prosthesis is inserted into a vein;

FIG. 3 is a schematic perspective view of an elastic membrane;

FIG. 4 is a schematic view of the elastic membrane disposed in the stent;

fig. 5 is a schematic perspective view of a leaflet mounting structure provided in an embodiment of the present application;

figure 6 is a perspective view of a leaflet structure;

FIG. 7 is a side schematic view of the lobe mounting structure of FIG. 5;

FIG. 8 is a schematic top view of the lobe configuration of FIG. 6;

figure 9 is a schematic diagram of a leaflet structure with possible leaflet buckling.

Wherein, in the figures, the respective reference numerals:

100. a support; 121. seaming the beam; 122. mounting a beam; 141. a first positioning ring; 142. a second positioning ring; 200. a leaflet structure; 210. a leaflet segment; 211. a leaflet; 2111. a movable edge; 2112. sewing the edges; 212. a spacer section; 2121. a spacing edge; 220. a fixed section; 2000. an elastic film; 300. a sealing film; 400. the venous vessels.

Detailed Description

In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application clearer, the present 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 merely illustrative of the present application and are not intended to limit the present application.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered as limiting the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

Referring to fig. 1 to 7, a leaflet mounting structure according to an embodiment of the present application will now be described. The valve leaflet mounting structure is used in a vein prosthesis valve so as to facilitate the intervention of the vein prosthesis valve or the implantation of the vein prosthesis valve into a human body to replace a native vein valve, thereby realizing the purpose of treating venous reflux.

The leaflet mounting structure comprises a leaflet structure 200 and a support 100, wherein the leaflet structure 200 is sutured on the support 100 through a suture; the leaflet structure 200 comprises two leaflets 211, wherein the two leaflets 211 are formed by sewing the two leaflets 211 on the support 100 at different circumferential positions of the cylindrical elastic membrane 2000; the leaflet 211 has a movable edge 2111 and a suturing edge 2112, the movable edge 2111 is located on one axial end surface of the elastic membrane 2000, the suturing edge 2112 is located on the membrane wall of the elastic membrane 2000, the suturing edge 2112 extends from one end of the movable edge 2111 to the other end of the movable edge 2111 along a curve, and the suturing edge 2112 is sutured to the stent 100. The two valve leaflets 211 can elastically deform under the action of the pressure of the blood flowing along the positive direction and drive the two movable edges 2111 to be separated from each other, and the two valve leaflets 211 can elastically deform under the action of the pressure of the blood flowing along the reverse direction and drive the two movable edges 2111 to be tightly abutted against each other; the arc length of the two movable edges 2111 is smaller than the diameter of the elastic membrane 2000.

The forward direction referred to in the present application is a direction in which blood flows from the venous valve to the heart, specifically, the Z1 direction in fig. 2, and the reverse direction is a direction in which blood flows back from the heart to the venous valve, specifically, the Z2 direction in fig. 2. When the leaflet structure 200 is subjected to blood pressure flowing in a positive direction, the leaflet structure 200 opens and blood can flow to the heart through the leaflet structure 200; when the valve leaflet structure 200 is under the pressure of blood flowing in the reverse direction, the valve leaflet structure 200 is pressed to be closed, so that the blood can not flow back to the venous blood vessel 400 from the heart through the valve leaflet structure 200, and the purpose of treating venous reflux is achieved.

The elastic membrane 2000 has a first end and a second end, which are oppositely disposed, the first end is an end of the elastic membrane 2000 close to the heart, and the second end is an end of the elastic membrane 2000 far from the heart.

Specifically, the movable edge 2111 is located on an end surface of a first end of the elastic membrane 2000, the sewing edge 2112 is located on a side wall of the elastic membrane 2000, and the sewing edge 2112 extends from one end of the movable edge 2111 to the other end of the movable edge 2111 along a curve; the sewing rim 2112 is sewn to the stent 100.

In this embodiment, the at least two leaflets 211 are demarcated on the elastic film 2000 by suturing different circumferential positions of the elastic film 2000 to the stent 100 along at least two suture edges 2112; when blood flows through the leaflet structure 200 in the positive direction, the blood flows from the center of the second end of the elastic membrane 2000 to between the leaflets 211, the leaflets 211 are pressed by the inner side walls of the leaflets 211, so that the leaflets 211 are separated radially outward, and the blood flows to the heart; when blood flows from the heart in the reverse direction through the leaflet structure 200, the blood presses the leaflets 211 from the outer sidewalls of the leaflets 211 to deform the leaflets 211 and bring the movable edges 2111 closer together to close, thereby preventing backflow of blood to the venous blood vessel 400.

Further, as shown in fig. 8, when the two leaflets 211 are closed, the two movable edges 2111 come close to the center of the elastic membrane 2000 and abut against each other by the action of the blood pressure; when the arc length of the movable edge 2111 is smaller than the diameter of the elastic membrane 2000, when the two movable edges 2111 abut against each other, the two movable edges 2111 can be in an elastic straight state, that is, the whole leaflet 211 is in a stretched state, and the leaflet 211 cannot be folded and bent as in fig. 9, so that the service life of the leaflet 211 in the use process is ensured, and the service life of the artificial venous valve using the leaflet 211 is further prolonged, and the stability of blood flow performance is improved.

The valve leaflet mounting structure in this embodiment sets up valve leaflet structure 200 as two valve leaflets 211 and can produce elastic deformation and drive two movable edges 2111 and part each other under the blood pressure effect that flows along the positive direction to can produce elastic deformation and drive two movable edges 2111 and support each other tightly under the blood pressure effect that flows along the contrary direction, thereby can realize the one-way flow of blood in venous vessel 400, avoid blood reflux phenomenon to appear, fundamentally has solved the palirrhea problem of vein. Meanwhile, the two leaflets 211 are formed by sewing the different circumferential positions of the cylindrical elastic membrane 2000 on the support 100, so that each leaflet 211 does not need to be cut and manufactured, only the position where the leaflet 211 needs to be sewn is needed to be sewn on the support 100 through a sewing thread, and the manufacturing process is simple. In addition, the arc length of the movable edges 2111 of the two valve leaflets 211 is set to be smaller than the diameter of the elastic film 2000, so that when the two movable edges 2111 abut against each other, the two movable edges 2111 can be in an elastic straight state, namely, the valve leaflets 211 are integrally in a stretching state, the valve leaflets 211 cannot be folded and bent, the service life of the valve leaflets 211 in the using process is ensured, and the service life of the artificial venous valve using the valve leaflets 211 and the stability of blood flow performance are further improved.

In one embodiment, referring to fig. 5 and 6, a spacer 212 is connected between at least one side of the two leaflets 211 along the circumferential direction, a side of the spacer 212 on the axial end surface where the movable side 2111 is located is a spacer side 2121, and the spacer side 2121 is connected between the two movable sides 2111; the spacer 212 is sewn to the bracket 100.

Note that, the leaflet 211 has two sides in the circumferential direction, and when one spacer 212 is provided between the two leaflets 211, the spacer 212 is connected between the two leaflets 211 on one side in the circumferential direction, and the two leaflets 211 are connected to each other at least at the position of the movable edge 2111 on the other side in the circumferential direction. When two spacers 212 are provided between the two leaflets 211, the spacers 212 are connected between both sides of the two leaflets 211 in the circumferential direction.

Because the spacing edge 2121 and the two movable edges 2111 are on the same axial end face, the arrangement of the spacing edge 2121 can reduce the arc length of the two movable edges 2111, and then the arc length of the two movable edges 2111 is smaller than the diameter of the elastic film 2000, so that when the two movable edges 2111 are in an elastic straight state, the leaflet 211 cannot fold or bend.

In addition, the spacing portion 212 is sewn and fixed on the bracket 100, so that the spacing portion 212 can be supported by the bracket 100, and therefore the spacing edge 2121 can be supported to be straightened, and then the movable edges 2111 on the two sides are also pulled to be straightened, and the probability that the movable edges 2111 on the two sides are folded and bent is reduced.

Optionally, the leaflet structure 200 includes two spacers 212, the two spacers 212 being connected between two sides of the two leaflets 211; the spacing edges 2121 of the two spacers 212 and the active edges 2111 of the two leaflets 211 are one axial end surface of the elastic membrane 2000. In this embodiment, the two spacers 212 are disposed, so that the lengths of the movable edges 2111 of the two leaflets 211 can be symmetrically reduced, and the two spacers 212 can be supported and stretched by the stent 100 to stretch the two movable edges 2111, thereby further reducing the probability of folding and bending of the two movable edges 2111.

Referring to fig. 5, the two leaflets 211 are symmetrically disposed along the circumferential direction, and the two spacers 212 are symmetrically disposed along the circumferential direction, so that when receiving blood pressure, the two leaflets 211 can be symmetrically closed or separated, and the leaflet structure 200 has a good one-way effect.

In one embodiment, when the leaflet structure 200 includes two spacing portions 212, the arc length of the two spacing edges 2121 ranges from 0.5mm to 2mm. Specifically, if the arc length of the spacing edge 2121 is L1, the arc length of the movable edge 2111 is L2, and the diameter of the elastic membrane 2000 is D, then 2l1+2l2=2 pi, that is, L1+ L2= pi, and since L1 is smaller than D, that is, pi-L2 is smaller than D, and D is the diameter of the elastic membrane 2000, the diameter thereof is also adapted to the diameter of the venous blood vessel 400, and therefore, the arc length of the spacing edge 2121 is limited within a certain range, so that the leaflet structure 200 can be applied to the venous blood vessel 400 having a diameter within a certain range.

In one embodiment, referring to fig. 5, the bracket 100 is provided with a mounting beam 122 disposed in a closed loop, the mounting beam 122 is attached to the spacer 212 at a position close to the spacer 2121, a peripheral side wall of the mounting beam 122 is connected to a corresponding position of the spacer 212 by stitching, and the mounting beam 122 is used for supporting the spacer 212. The spacer 212 is sewn and fixed on the mounting beam 122 at a position close to the spacer edge 2121, so that the spacer 212 can be supported by the mounting beam 122, the spacer edge 2121 can be supported in a stretching state, the length of the movable edge 2111 of the leaflet 211 can be reduced to a certain extent to prevent the leaflet 211 from being bent and folded, and meanwhile, the spacer can stretch the leaflet 211, thereby being beneficial to straightening the leaflet 211 and prolonging the service life of the leaflet 211.

Optionally, referring to fig. 5, the mounting beam 122 is circular, that is, the suture locus of the spacer 212 on the stent 100 is circular, and its regular shape is also beneficial for positioning the subsequent leaflet structure 200 on the stent 100. It should be understood that, in other embodiments of the present application, the mounting beam 122 may also have a shape of a square, a rectangle, an ellipse, a diamond, or an irregular closed loop, as long as the spacer 212 can be sewn on the corresponding position of the stent 100 and can support the spacer 212, which is not limited herein.

In one embodiment, referring to fig. 5 and 6, the leaflet structure 200 includes a fixed section 220 and a leaflet section 210, the fixed section 220 and the leaflet section 210 are integrally connected along an axis, and the fixed section 220 and the leaflet section 210 are two parts of the elastic membrane 2000 connected along the axis. The fixing section 220 is cylindrical, the fixing section 220 is connected with the stent 100 in a sewing mode, a sealing film 300 in the artificial venous valve is arranged corresponding to the fixing section 220 in a fitting mode and is attached to the fixing section 220, and at least two valve leaflets 211 are formed in the valve leaflet section 210. In this embodiment, still set up the canned paragraph 220 through the basis at the leaflet section 210 for can be through canned paragraph 220 with leaflet structure 200 stable mounting on support 100, canned paragraph 220 is cylindrically simultaneously, canned paragraph 220 still with the setting of sealing membrane 300 laminating, thereby make between leaflet structure 200 and the sealing membrane 300 leakproofness good.

In one embodiment, referring to fig. 5 and 7, the stent 100 is provided with a plurality of positioning rings, the plurality of positioning rings are arranged at intervals along the axial direction and the circumferential direction of the stent 100, and each positioning ring is used for suturing and connecting with the leaflet structure 200 at different positions along the axial direction and the circumferential direction, so as to realize the axial and circumferential positioning of the leaflet structure 200 on the stent 100. In this application, leaflet structure 200 needs to be sewed up on support 100 through the suture line, and leaflet 211 among the leaflet structure 200 has the seam limit 2112, need sew up the seam limit 2112 on support 100 leaflet 211 can play a role, consequently the suture position of leaflet 211 on support 100 can not have the mistake, this application can be earlier through a plurality of holding rings with leaflet structure 200 a preliminary positioning on support 100, then sew up corresponding every leaflet 211 again, thereby can reduce the degree of difficulty that leaflet 211 sews up, also improve the precision of sewing up of leaflet 211 simultaneously.

In an embodiment, referring to fig. 5 and fig. 7, four positioning rings are disposed on the bracket 100, which are two first positioning rings 141 and two second positioning rings 142, respectively, the two first positioning rings 141 and the two second positioning rings 142 are axially spaced, the two first positioning rings 141 are circumferentially spaced, the two second positioning rings 142 are circumferentially spaced, and the two first positioning rings 141 and the two second positioning rings 142 are circumferentially spaced at equal intervals; a second positioning ring 142 is arranged between the two first positioning rings 141 along the circumferential direction; two first positioning rings 141 are used for connecting with the valve leaflet segment 210, in particular, two first positioning rings 141 are used for suturing with two spacers 212, and two second positioning rings 142 are used for connecting with the fixing segment 220.

The two first positioning rings 141 are two mounting beams 122, that is, the mounting beams 122 can support the spacer 212 and position the entire leaflet structure 200, and the structure is simple.

In one embodiment, referring to fig. 5 and 7, the stent 100 further comprises two sewing beams 121, and the elastic membrane 2000 is sewn at different circumferential positions on the two sewing beams 121 to form the sewing edges 2112 of the two leaflets 211. In actual installation, the elastic membrane 2000 is firstly sewn and positioned in the stent 100 through each positioning ring, and then the position of the elastic membrane 2000 corresponding to each sewing beam 121 is sewn together with the sewing beam 121 along the extending track of the sewing beam 121 through a sewing thread to form a sewing edge 2112, thereby forming the valve leaflet 211. This application is through setting up seam roof beam 121 on support 100 for the installer only need pass through the stylolite along seam roof beam 121 with the position that corresponds seam roof beam 121 on the elastic membrane 2000 and sew together with seam roof beam 121, can form and sew up limit 2112 and leaflet 211, easy operation, and be difficult to make mistakes.

Wherein, the number of the suture beams 121 is the same as the number of the leaflets 211 to be designed, and the designer can set the number of the suture beams 121 as required.

Similarly, the extension curve and the extension length of the suture beam 121 may be designed according to the shape and the size of the leaflet 211 to be designed. For example, the suture beams 121 may extend along an elliptical curve, along a circular arc curve, along a hyperbolic curve, or along a spline curve, such that the formed suture edges 2112 may also extend along an elliptical curve, along a circular arc curve, along a hyperbolic curve, or along a spline curve, such that the shape of the leaflets 211 is defined.

In a preferred embodiment, the elastic membrane 2000 is made of animal pericardium, such as bovine pericardium or porcine pericardium. The pericardial material may be selected from animal blood vessels, including the intima or adventitia of venous 400 or arterial blood vessels. The natural animal blood vessel has three layer construction, including intima, mesolamella and adventitia three-layer, wherein, intima and adventitia have better toughness and elasticity, and this application can peel off the intima of the blood vessel of the same specification from the blood vessel to be used as leaflet 211 material, and then make the toughness and the elasticity of the leaflet 211 of making all very good, simultaneously can also be close with the leaflet 211 performance of human venous valve, make the treatment of the artificial venous valve of making through this leaflet 211 better.

On the other hand, the application also provides a venous prosthesis, which comprises a sealing membrane 300 and the valve leaflet installing structure, wherein the sealing membrane 300 is sewn on the support 100 through a suture, the sealing membrane 300 is sleeved on the periphery of the valve leaflet structure 200 and is in sealing connection with the valve leaflet structure 200, and the sealing membrane 300 can be propped open by the support 100 to be in sealing abutment with the inner wall of the venous vessel 400.

Wherein the stent 100 has elasticity and can be radially expanded to be positioned in the vein vessel 400, thereby realizing the introduction of the artificial vein valve into the vein vessel 400 of the human body and the positioning in the vein vessel 400 of the human body; meanwhile, the leaflet structure 200 and the sealing membrane 300 are sewn on the support 100 by using sewing threads, so that the support 100 also has the function of supporting the leaflet structure 200 and the sealing membrane 300.

The leaflet structure 200 can open under the effect of the blood pressure flowing in the positive direction and can close under the effect of the blood pressure flowing in the reverse direction, so that the unidirectional flow of blood in the venous vessel 400 can be realized, and the phenomenon of regurgitation of blood is avoided.

The sealing membrane 300 is connected with the valve leaflet structure 200 in a sealing way, and the sealing membrane 300 can be propped open by the support 100 to be sealed with the inner wall of the venous vessel 400, so that blood cannot flow from the position between the valve leaflet structure 200 and the inner wall of the venous vessel 400, and the valve peripheral leakage phenomenon is avoided.

To sum up, the artificial vein blood vessel 400 of this application is through the setting of above-mentioned support 100, leaflet structure 200 and sealing membrane 300 for it can intervene or implant in human venous blood to replace native venous valve, thereby reach the palirrhea purpose of treatment vein, fundamentally solves the palirrhea problem of vein.

The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims (10)

1. A leaflet mounting structure for use in a prosthetic venous valve, the leaflet mounting structure comprising a leaflet structure and a stent; the valve leaflet structure comprises two valve leaflets, and the two valve leaflets are formed by sewing different circumferential positions of a cylindrical elastic film on the support; the valve leaf is provided with a movable edge and a sewing edge, the movable edge is positioned on one axial end face of the elastic membrane, the sewing edge is positioned on the membrane wall of the elastic membrane, the sewing edge extends from one end of the movable edge to the other end of the movable edge along a curve, and the sewing edge is sewn on the support; the two valve leaflets can elastically deform under the action of the pressure of blood flowing along the positive direction and drive the two movable edges to be separated from each other, and the two valve leaflets can elastically deform under the action of the pressure of the blood flowing along the reverse direction and drive the two movable edges to be abutted against each other; the arc length of the movable edge is smaller than the diameter of the elastic membrane.

2. The leaflet mounting structure of claim 1, wherein a spacer is connected between two of the leaflets on at least one side in a circumferential direction; the edge of the spacing part, which is positioned on the axial end face where the movable edge is positioned, is a spacing edge, and the spacing edge is connected between the two movable edges; the spacing part is sewn and fixed on the bracket.

3. The leaflet mounting structure of claim 2, wherein the leaflet structure comprises two of the spacers connected between two sides of the leaflets; the spacing edges of the two spacing parts and the movable edges of the two valve leaflets jointly form an axial end face of the elastic membrane.

4. The leaflet mounting structure of claim 2 or 3, wherein the support is provided with a mounting beam arranged in a closed loop, the mounting beam is attached to the position of the spacing part close to the spacing edge, a peripheral side wall of the mounting beam is connected with a corresponding position of the spacing part in a sewing way, and the mounting beam is used for supporting the spacing part.

5. The leaflet mounting structure of claim 4, wherein the mounting beam is circular, square, rectangular, oval, diamond, or an irregular closed loop shape.

6. The leaflet mounting structure of claim 2 or 3, wherein the leaflet structure comprises an axially connecting fixation section and a leaflet section, the fixation section being cylindrical, the fixation section being sutured to the stent, the leaflets and the spacers being circumferentially distributed about the leaflet section.

7. The leaflet mounting structure of claim 6 wherein the frame further comprises a plurality of retaining rings spaced axially and circumferentially along the frame, the retaining rings adapted to be sutured to the spacer or the retaining segment to retain the leaflet structure.

8. The leaflet mounting structure of any one of claims 1-3, wherein the frame comprises two sewing beams, and the different circumferential positions of the elastic membrane correspond to the sewing edges of the two leaflets to be sewn thereon.

9. The leaflet mounting structure of any one of claims 1-3, wherein the elastic membrane is made of animal pericardium.

10. A prosthetic venous valve comprising the leaflet mounting structure of any one of claims 1-9.

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