CN212234805U - Venous valve support and venous valve prosthesis - Google Patents

Abstract

The utility model provides a venous valve support and venous valve false body. The venous valve support comprises a support body and a sinus cavity support; the bracket body is of a hollow cylindrical structure and can radially extend and retract; the side part of the bracket body is provided with a window; the sinus cavity frame is provided with a fixed end and a free end which are opposite; the fixed end is connected to the windowing part; the free end is suspended outside the bracket body; the inner side of the sinus cavity frame forms a sinus area which is communicated with the interior of the bracket body through the fenestration. The venous valve prosthesis comprises a valve and the venous valve support, wherein the valve is fixed in the support body and covers at least partial area of a sinus region, and one side of the valve, which is far away from the sinus region, is a free edge. The utility model discloses can improve the reliability of one-way conduction function to can avoid the overstimulation to blood vessel, still make things convenient for the preparation.

Description

Venous valve support and venous valve prosthesis

Technical Field

The utility model relates to the technical field of medical equipment, in particular to venous valve support and venous valve false body.

Background

The venous surgical diseases are common surgical diseases, mostly occur in lower limbs, and are mainly clinically manifested as varicose veins, limb swelling, skin dystrophy diseases in foot and boot areas, such as dermatitis, pigmentation, ulceration and the like. The main pathological reason is that the venous valve loses the basic function of unidirectional opening under the action of pathogenic factors. The mild patients with venous diseases obstruct life and working ability, and the severe patients can cause diseases and disabilities with different degrees. Therefore, the treatment of venous valvular disease of the lower extremities is increasingly gaining importance. At present, most of the diseases are clinically treated by conservative treatment, such as drug treatment, pressure pump and the like, and surgical treatment, such as femoral vein valve repair and reconstruction surgery and the like, has unsatisfactory clinical effect. Vein valve transplantation appears to be the only method of choice, particularly in patients with severe vein valve destruction or congenital valvulopathy.

Currently, the commonly used clinical method is to transplant an autologous iliac vein prosthesis or popliteal vein prosthesis with a valve, the prosthesis is implanted into a vein, a stent of the prosthesis is attached to the vein, a channel through which blood passes is constructed in the stent, and the valve positioned in the stent can open or close the channel to realize a one-way opening function. However, in such a structure, local thrombus is likely to form between the valve and the stent, and the valve is likely to be degenerated and has insufficient anti-regurgitation ability, and the effect is not satisfactory in the future.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a better venous valve support of reliability and venous valve false body.

In order to solve the technical problem, the utility model adopts the following technical scheme:

according to one aspect of the present invention, the present invention provides a venous valve stent, comprising a stent body and a sinus cavity stent; the bracket body is of a hollow cylindrical structure and can radially extend and retract; the side part of the bracket body is provided with a window; the sinus cavity frame is provided with a fixed end and a free end which are opposite; the fixed end is connected to the windowing part; the free end is suspended outside the bracket body; the inner side of the sinus cavity frame forms a sinus region which is communicated with the interior of the bracket body through the windowing.

In some embodiments, the free end does not extend beyond an outermost side of a remainder of the sinus shelf other than the free end in a radial direction along the stent body.

In some embodiments, the sinus cavity stent comprises a first extension section and a second extension section in the direction from the fixed end to the free end along the axial direction of the stent body, and the distance from the first extension section to the central axis of the stent body is gradually increased; the joint of the first extension section and the second extension section is the outermost side of the sinus cavity frame, and the tail end of the second extension section is the free end.

In some embodiments, the distance from the second extension to the central axis of the stent body decreases gradually in a direction from the outermost side to the free end.

In some embodiments, the distance from the second extending section to the central axis of the stent body decreases at a gradually increasing speed in the direction from the outermost side to the free end.

In some embodiments, the second extension extends linearly.

In some embodiments, the distance from the second extension to the central axis of the stent body remains constant.

In some embodiments, the distance from the first extension to the central axis of the stent body increases at a gradually decreasing rate in a direction from the fixed end to the outermost side.

In some embodiments, the first extension extends linearly.

In some embodiments, the sinus scaffold comprises a first strut and a second strut; the first end of the first supporting rod is separated from the first end of the second supporting rod and is used as the fixed end to be connected to the windowing part respectively; the second end of the first strut is connected to the second end of the second strut and forms the free end.

In some embodiments, the second end of the first strut and the second end of the second strut are directly connected.

In some embodiments, the sinus cavity shelf further comprises a cross bar; the cross rod extends along the circumferential direction of the support body, and two ends of the cross rod are respectively connected with the second end of the first supporting rod and the second end of the second supporting rod.

In some embodiments, the first and second struts gradually approach each other in a direction along the first end to the second end.

In some embodiments, the included angle between the first strut and the second strut is between 30 ° and 90 °.

In some embodiments, the first strut and the second strut are symmetrical.

In some embodiments, the fenestration is located in an axially central region of the stent body.

In some embodiments, the sinus cavity has a length in the axial direction of the stent body that is greater than half the length of the fenestration in the axial direction of the stent body.

In some embodiments, the bracket body comprises two supporting bodies arranged at intervals and a plurality of upright posts connected between the two supporting bodies; the support body is in a cylindrical shape with a circumferential closed loop; the two support bodies are coaxially arranged and are opposite to each other at intervals along the axial direction; a plurality of said posts are circumferentially spaced about a central axis of said support body; the window is formed in the interval between two adjacent upright posts.

In some embodiments, the support body comprises a plurality of undulating rings that are axially contiguous; each wave ring is provided with a wave crest and a wave trough which are staggered along the circumferential direction, and the wave crests and the wave troughs of two adjacent wave rings are connected to form a grid shape; the upright post is connected with the opposite wave crests and wave troughs of the two supporting bodies.

In some embodiments, the post is linear and extends in an axial direction of the stent body.

In some embodiments, the holder body is a unitary structure, and the entire outer peripheral wall of the holder body is in a net shape, and the window is formed in the outer peripheral wall.

In some embodiments, the number of the fenestrations is multiple, and the fenestrations are distributed along the circumference of the stent body; the sinus cavity frame is provided with a plurality of sinuses frames which are connected with the windowing part in a one-to-one correspondence mode.

According to another aspect of the present invention, there is provided a venous valve prosthesis comprising a valve and a venous valve stent as described above; the valve is fixed in the stent body and covers at least a partial area of the sinus region; the valve has a free edge on a side of the valve facing away from the sinus region.

In some embodiments, the venous valve prosthesis further comprises a membrane covering the entire peripheral wall of the venous valve stent.

According to the above technical scheme, the utility model discloses following advantage and positive effect have at least: the utility model discloses an among the venous valve support, the support body is the tubular structure that can radially stretch out and draw back, therefore venous valve support can be the holding of contraction status ground before implanting the human body in conveying pipe to utilize conveying pipe to carry it intravenous, the operation wound is little. After the stent is implanted into a human body, the stent body radially expands and anchors in a blood vessel through self expansion, a channel for blood to pass through is constructed in the stent body, and the stent can be matched with a valve loaded in the venous valve stent to reconstruct the one-way conduction function of the vein and prevent venous blood from flowing back.

In particular, the venous valve stent has a sinus cavity shelf that is convex with respect to the stent body, forming a sinus region inside the sinus cavity shelf. The venous valve support carries a valve, and can form vortex in a sinus region when blood flows backwards. Based on the vortex formed in the sinus region, when blood flows downstream, the acting force of the downstream blood on the valve is balanced with the pressure generated by the vortex, so that the valve leaflets of the valve can suspend without contacting with the venous valve support, and the risk of valve leaflet adhesion is reduced; in addition, when the blood flows back, the leaflet which is collided and suspended by the backflow blood can be more easily deformed towards the direction of closing the blood flow channel to quickly close the channel compared with the leaflet which is collided and jointed with the venous valve support, so that the sensitivity and the reliability of the one-way opening function are improved. Meanwhile, under the action of vortex in the sinus region, the backflow blood can be guided to flow towards the heart again, the accumulation of the blood is effectively avoided, and the risk of forming local thrombus is reduced.

Furthermore, in the scheme, the free end of the sinus cavity frame is suspended outside the stent body, so that the sinus cavity frame has elasticity in the radial direction, the sinus cavity frame can be prevented from excessively stimulating blood vessels, the damage to the blood vessels is reduced, and the excessive hyperplasia of the blood vessels is prevented. Meanwhile, the sinus cavity frame is connected to the windowing part of the bracket body through the fixed end of the sinus cavity frame, the structural shape of the sinus cavity frame is not restricted by the bracket body, the sinus cavity frame is convenient to manufacture and connect with the bracket body, and after the sinus cavity frame is implanted into a human body, the structural form of the sinus cavity frame protruding out of the bracket body is also convenient to maintain the stability of a sinus region.

Drawings

Fig. 1 is a schematic structural view of a first embodiment of the venous valve prosthesis of the present invention.

Fig. 2 is a front view of fig. 1.

Fig. 3 is a top view of fig. 1.

Fig. 4 is a schematic view of the structure of fig. 1 with the thin film removed.

Fig. 5 is a front view of the venous valve stent of fig. 1.

Fig. 6 is a side view of fig. 5.

Figures 7 and 8 are schematic cross-sectional views of figure 1 after implantation in a human blood vessel, showing the valve open and closed, respectively.

Fig. 9 is a schematic structural view of a second embodiment of the venous valve prosthesis of the present invention.

Fig. 10 is a top view of fig. 9.

Fig. 11 is an internal structural view of fig. 9.

Fig. 12 is a schematic structural view of the venous valve stent of fig. 9.

Fig. 13 is a schematic structural view of a third embodiment of the venous valve prosthesis of the present invention.

Fig. 14 is a top view of fig. 13.

Fig. 15 is a schematic structural view of a fourth embodiment of the venous valve prosthesis of the present invention.

Fig. 16 is a schematic structural view of the venous valve stent of fig. 15.

Fig. 17 is a schematic structural view of a fifth embodiment of the venous valve prosthesis of the present invention.

Fig. 18 is a front view of fig. 17.

Fig. 19 is a schematic structural view of a sixth embodiment of the venous valve prosthesis of the present invention.

Fig. 20 is a side view of the venous valve stent of fig. 19.

Fig. 21 is a front view of fig. 20.

Fig. 22 is a schematic structural view of a seventh embodiment of the venous valve prosthesis of the present invention.

Fig. 23 is a front view of fig. 22.

The reference numerals are explained below:

100/100a/100b/100c/100d/100e/100f, venous valve prosthesis; 500. a blood vessel;

1/1a/1b/1c/1d/1e/1f, venous valve stent; 101/101a, a channel; 102/102a/102b, sinus region;

11/11a/11c/11d/11e/11f, stent body; 111/111e, a support; 1111/1111f, wave ring; 1115. wave crest; 1116. a trough of a wave; 1112. a developing rod; 112/112a/112b/112e, posts; 115/115f, windowing;

12/12a/12b/12c/12d/12e/12f, sinus cavity shelf; 1201/1201c, a first extension; 1202/1202c, a second extension; 1203/1203c, free end; 1204/1204c, outermost; 121/121d/121e, a first strut; 122/122d/122e, a second strut; 123d, a cross bar;

2/2a/2b, valve; 201. fixing the edge; 202/202a, free edge; 21. a flap body; 22. a leaflet;

3/3a/3d, film.

Detailed Description

Exemplary embodiments that embody features and advantages of the present invention will be described in detail in the following description. It is to be understood that the invention is capable of other and different embodiments and its several details are capable of modification without departing from the scope of the invention, and that the description and drawings are to be regarded as illustrative in nature and not as restrictive.

The utility model provides a venous valve support and venous valve false body for the intervention treatment of venous valve insufficiency. The venous valve prosthesis comprises the venous valve support and a valve connected in the venous valve support. The venous valve prosthesis is delivered into a diseased vein through a delivery catheter by means of percutaneous puncture and is accurately positioned and released, so that the venous valve prosthesis has the function of preventing venous blood from flowing back.

For ease of description, it is defined herein that "proximal" refers to the end that is proximal to the cardiac site, and "distal" refers to the end that is distal from the cardiac site. Normal blood flow in a human vein is in the direction of the heart, i.e. from the distal end to the proximal end.

The following is a detailed description of several embodiments of the venous valve prosthesis.

The first embodiment refers to the structure and the using state shown in fig. 1 to 8.

Referring first to fig. 1 to 4, the venous valve prosthesis 100 of the present embodiment includes a venous valve stent 1, a valve 2, and a membrane 3.

Wherein, the venous valve support 1 is a bare support, a channel 101 for blood supply to pass through the far end and the near end is formed inside the venous valve support in the unfolding state, and a convex sinus region 102 is also formed at the side of the venous valve support 1 in the embodiment. The film 3 can be sewed on the inner side of the venous valve support 1, and also can be sewed on the outer side of the venous valve support 1 to cover the whole peripheral wall of the venous valve support 1, and the film 3 and the venous valve support 1 are combined into a whole to increase the contact area of the venous valve prosthesis 100 and the blood vessel of the human body. The valve 2 is of a single-valve structure, is positioned inside the venous valve support 1, is fixedly connected with the venous valve support 1, covers at least part of the sinus region 102, and plays a role in one-way conduction.

Referring to fig. 5 and 6, the venous valve stent 1 includes a stent body 11 and a sinus cavity stent 12 connected to the side of the stent body 11. The holder body 11 has a hollow cylindrical structure as a whole, and thus a passage 101 is formed inside thereof. A window 115 is arranged on the side of the bracket body 11; the sinus cavity truss 12 is connected to the opening 115 and protrudes outward with respect to the stent body 11, so that the sinus region 102 is formed inside the sinus cavity truss 12, and the sinus region 102 communicates with the passage 101 inside the stent body 11 through the opening 115.

The bracket body 11 of the present embodiment mainly includes two supporting bodies 111 disposed at intervals and a plurality of columns 112 connected between the two supporting bodies 111.

The support body 111 is a self-expanding structure, and has a cylindrical shape with a circumferentially closed loop, and a central axis thereof is aligned with a central axis of the entire stent body 11, which is denoted by L in fig. 6. The two support bodies 111 are coaxially arranged and axially spaced apart from each other.

Each support 111 has a plurality of axially contiguous undulating rings 1111. Each wave ring 1111 has alternating crests 1115 and troughs 1116 in the circumferential direction. With peaks 1115 proximally and valleys 1116 distally. The wave crests 1115 and the wave troughs 1116 of two adjacent wave-shaped rings 1111 are connected to form a grid.

Adjacent wave crests 1115 and adjacent wave troughs 1116 of each wave ring 1111 may be spaced toward or away from each other, so that the support body 111 and thus the entire stent body 11 may be radially expanded or contracted. The stent body 11 is in a contracted state before being implanted into a human body to be accommodated in the delivery catheter, and is expanded and anchored at a predetermined position of a blood vessel of the human body by self-expansion after being implanted into the human body. In particular, the anchoring is mainly realized by the adherent combination of the supporting body 111 and the human blood vessel after the supporting body is radially expanded.

In the structure shown in fig. 5, each support 111 has two wave-shaped rings 1111. Each wave ring 1111 can be seen as a closed loop structure extending from the rod in a Z-shaped bend. Each wave ring 1111 has a total of eight wave crests 1115 and eight wave troughs 1116 arranged in a circumferentially staggered manner. The wave troughs 1116 of the proximal wave ring 1111 are connected with the wave crests 1115 of the distal wave ring 1111, forming eight diamond-shaped grids connected in series along the circumference of the support body 111. The two wave-shaped rings 1111 form a circumferential closed-loop structure, so that the venous valve support 1 has high radial supporting force and better anchoring effect.

Two developing rods 1112 protrude proximally from the support 111 at the proximal end, and two developing rods 1112 protrude distally from the support 111 at the distal end. The two developing rods 1112 on each support 111 are circumferentially opposed, and the four developing rods 1112 are circumferentially staggered. The developing rod 1112 can be provided with a developing mark for conveniently displaying the position of the venous valve support 1 during implantation. The developing mark is provided on the developing rod 1112 with a developing material, and may be provided in a dot shape, a line shape, or the like. In this embodiment, the end of the developing rod 1112 is annular and can be used to press a dot-like developing mark.

Each of the pillars 112 is linear and extends in the axial direction of the stent body 11. A plurality of uprights 112 are circumferentially spaced about the central axis L of the support body 111. The cylindrical structure enclosed by the plurality of columns 112 is coaxial with the support body 111.

The two ends of the upright post 112 are connected to the peaks 1115 and the valleys 1116 of the two supporting bodies 111. Namely: the proximal ends of the posts 112 are connected to the valleys 1116 of the proximal support 111 and the distal ends of the posts 112 are connected to the corresponding peaks 1115 of the distal support 111.

Specifically, in this embodiment, the number of the columns 112 is four, the columns 112 are uniformly arranged between the two support bodies 111 in the circumferential direction, and every other wave crest 1115 or wave trough 1116 in the circumferential direction is connected to one column 112. The space between two adjacent columns 112 forms a window 115, and the distance between the two supports 111 or the length of the column 112 constitutes the axial length of the window 115.

This support body 11's structure, the utilization is located the supporter 111 that is closed loop structure at both ends and can provides good radial holding power, has the advantage that the anchoring force is strong, is convenient for and human blood vessel laminating is fixed. The upright column 112 in the middle increases the axial rigidity of the venous valve support 1, and the venous valve support 1 is convenient to keep the shape stability. Preferably, the width of the upright 112 is greater than the rod width of the undulating rings 1111 of the support 111.

Still referring to fig. 5 and 6, the sinus cavity stent 12 is attached to the fenestration 115 of the stent body 11. The sinus cavity housing 12 includes a first strut 121 and a second strut 122. The first or distal end of the first strut 121 is spaced apart from the first or distal end of the second strut 122 and each is connected to a post 112 defining the fenestration 115. The second or proximal end of the first strut 121 is contiguous with the second or proximal end of the second strut 122 and forms the free end 1203 of the sinus cavity shelf 12; the free end 1203 overhangs the outside of the holder body 11. The space enclosed between the first strut 121, the second strut 122, and the two struts 112 to which they are connected forms the sinus region 102.

As shown in fig. 5, in the present embodiment, the first and second struts 121 and 122 gradually come close to each other in the distal-to-proximal direction. The proximal end of the first strut 121 is directly connected to the proximal end of the second strut 122, and the first strut 121 and the second strut 122 are connected to form a V-shape. Wherein preferably the first strut 121 and the second strut 122 are symmetrical. The included angle α formed by the first supporting rod 121 and the second supporting rod 122 is preferably in the range of 30 ° to 90 °. In this embodiment, the distal ends of the first strut 121 and the second strut 122 are respectively connected to the distal ends of the two columns 112, so that the radial supporting force of the supporting body 111 can be used to maintain the relative positions of the first strut 121 and the second strut 122.

In the distal-to-proximal direction along the axial direction of the stent body 11, the sinus cavity 12 starts at the distal end of the post 112 and extends proximally beyond the midpoint of the post 112 with a space between the supports 111 at the proximal end. That is, the length of the sinus cavity stent 12 in the axial direction of the stent body 11 is greater than half of the axial length of the fenestration 115, which facilitates the guiding of the blood flow and the deployment of the membrane 3.

Referring to fig. 6, in a direction from the distal end to the proximal end along the axial direction of the stent body 11, the sinus cavity stent 12 first gradually extends obliquely outward and then gradually extends obliquely inward with respect to the stent body 11. That is, the free end 1203 of the sinus cavity frame 12 is bent toward the inner side of the stent body 11, so that the free end 1203 of the sinus cavity frame 12 does not exceed the outermost side 1204 of the sinus cavity frame 12 in the radial direction of the stent body 11, and the damage of the free end 1203 of the sinus cavity frame 12 to the blood vessel tissue when the sinus cavity frame is implanted into the blood vessel of the human body can be effectively avoided.

For ease of description, the sinus cavity 12 is divided into a first extension 1201 near the distal end and a second extension 1202 near the proximal end in the axial direction of the stent body 11. In the distal-to-proximal direction, the distance Di from the first extension 1201 to the central axis L of the stent body 11 becomes gradually larger, and the distance Dj from the second extension 1202 to the central axis L of the stent body 11 becomes gradually smaller. The distal end of the first extension 1201 is connected to the stent body 11, the intersection of the first extension 1201 and the second extension 1202 forms the outermost side 1204 of the sinus cavity bridge 12 relative to the stent body 11, and the distal end of the second extension 1202 is the free end 1203.

From the appearance of the venous valve stent 1, the outer diameter of the support 111 of the stent body 11 is D1, the distance between the outermost side 1204 of the sinus cavity stent 12 and the side wall on the opposite side of the support 111 is D2, and D2 > D1. The difference between D2 and D1 is the maximum distance the sinus cavity 12 protrudes outward.

Further, in the present embodiment, the increasing speed of the distance from the first extension 1201 to the central axis L is gradually decreased, and the decreasing speed of the distance from the second extension 1202 to the central axis L is gradually increased in the distal-to-proximal direction.

That is, the first and second struts 121 and 122 are curved in the range of the first extension 1201 and the range of the second extension 1202, so that the deformation resistance of the first and second struts 121 and 122 can be improved. When the stent is implanted into a human blood vessel, the bending directions of the first struts 121 and the second struts 122 are both convex towards the blood vessel, and the first struts 121 and the second struts 122 can bear larger radial pressure brought by the blood vessel wall, so that the stability of the shape is kept.

It will be appreciated that in other possible configurations, the first and second extensions 1201, 1202 may also each extend in a straight line segment, with the rate of increase in the distance from the first extension 1201 to the central axis L and the rate of decrease in the distance from the second extension 1202 to the central axis L remaining constant in the distal to proximal direction. That is, first strut 121 and second strut 122 are straight segments in both the extent of first extension 1201 and the extent of second extension 1202. In addition, when the first extending section 1201 extends in a curved shape, the second extending section 1202 may extend linearly. When the first extending section 1201 extends linearly, the second extending section 1202 may extend in a curved line.

The sinus cavity frame 12 of the present embodiment has a simple structural form and is easy to manufacture. And the sinus cavity frame 12 has a small number of structural members and a small metal coverage rate, so that intimal hyperplasia caused by excessive stimulation to blood vessels of a human body is avoided. By using the sinus region 102 formed inside the sinus cavity frame 12, a vortex can be formed in the sinus region 102 during the blood backflow, which is beneficial to the pressure balance of the valve 2.

Based on the above-described structure of the venous valve stent 1, referring again to fig. 4, the valve 2 is located within the stent body 11 of the venous valve stent 1, is disposed in alignment with the sinus cavity stent 12, and covers at least a portion of the sinus region 102. The valve 2 has a substantially V-shaped fixing edge 201, and the fixing edge 201 is fixed to the stent body 11 or the membrane 3 by means of, for example, sewing or bonding.

The V-shaped apex of the fixation edge 201 is located on the side of the sinus cavity shelf 12 that is proximal to the sinus cavity shelf 12 and is more distal relative to the sinus cavity shelf 12. for example, the V-shaped apex of the fixation edge 201 may be located on a peak 1115 of the distal support 111 that is located between the two posts 112 to which the sinus cavity shelf 12 is attached.

The fixation edge 201 extends from the V-shaped apex obliquely proximally along the inner wall of the stent body 11 towards the opposite side of the sinus cavity stent 12 in the distal to proximal direction, so that the valve 2 covers a part of the sinus region 102 if seen in the front view shown in fig. 2 (the valve 2 is hidden and not shown in fig. 2). The length of the valve 2 in the axial direction of the stent body 11 may be, for example, beyond the sinus cavity stent 12.

The side of the valve 2 facing away from the sinus region 102 is not fixed to the holder body 11, thus forming a free edge 202, the two ends of which edge 202 are connected at the V-shaped opening of the fixed edge 201. By this change of position of the free edge 202, the valve 2 can close or open the passage 101 in the stent body 11.

When the blood flows from the proximal end to the distal end in the channel 101, the blood passes through the sinus region 102, pushing the valve 2 against the inner wall of the stent body 11 on the opposite side of the sinus cavity stent 12, so that the free edge 202 of the valve 2 is attached to the membrane 3 on the stent body 11, the blood cannot flow further through the valve 2 to the distal end, and the channel 101 is closed. When the blood flows from the distal end to the proximal end, the blood pushes the valve 2 towards the side of the sinus region 102, at which point the free edge 202 of the valve 2 separates from the membrane 3 and the passage 101 is opened. It should be noted that when the valve 2 is pushed against the inner wall of the stent body 11 on the opposite side of the sinus cavity stent 12, there may be a slight gap between the free edge 202 and the membrane 3, and the free edge 202 does not adhere to the membrane 3, so that the risk of adhesion of the free edge 202 to the stent body 11 or the membrane 3 is reduced, and the slight gap between the free edge 202 and the membrane 3 does not affect the valve 2 to block most of the backflow blood flow.

The valve 2 may be a valve comprising a valve body 21 and valve leaflets 22. The valve body 21 forms the above-mentioned fixed edge 201 and is connected and fixed to the venous valve stent 1, the leaflet 22 is connected between the valve bodies 21, the area of the leaflet 22 is larger than the area enclosed by the fixed edge 201, and the portion of the leaflet 22 not connected to the valve body 21 forms the free edge 202. The leaflet 22 can deform to form a sinus cavity between the leaflet 22 and the body 21. The free edge 202 of the leaflet 22 can be positionally changed by deformation of the leaflet 22, and switching between the closed and open states is achieved.

Based on the presence of the valve 2, a one-way passage of blood through the venous valve stent 1 is established, the valve 2 acting as a one-way valve.

The valve 2 and the membrane 3 are made of a heterogeneous biological material or a medical polymer material, such as polyester, polytetrafluoroethylene, polyurethane, medical silica gel, dacron, a biological valve, pericardium or other implantable medical materials.

Referring to fig. 7, when the venous valve prosthesis 100 of the present embodiment is implanted in a human blood vessel 500, the venous valve stent 1 is attached to the intima of the blood vessel 500. Under the effect of the backflow blood flow flowing from the near end to the far end, the valve 2 moves towards the opposite side of the sinus cavity frame 12 under the impact of the blood flow, so that the channel 101 in the stent body 11 is closed, the backflow of the blood at the far end is effectively avoided, the backflow blood flow flows towards the near end again due to the vortex formed in the sinus region 102, the blood is prevented from being detained and gathered at the root of the valve 2, and the formation of local thrombus can be avoided.

Referring to fig. 8, in the flowing process of the downstream blood flow in the blood vessel 500, a vortex is formed in the area of the sinus region 102 covered by the valve 2, which is beneficial to the pressure balance of the valve 2, and at this time, the leaflets 22 of the valve 2 are in a suspended state under the combined action of the vortex and the downstream blood flow, and do not adhere to the stent body 11, the membrane 3 or the inner wall of the blood vessel 500, so that the risk of adhesion can be reduced, the valve 2 is ensured to have the function of unidirectional closing continuously, and the formed vortex can also avoid the risk of thrombus formation due to the stagnation of the blood flow at the root of the valve 2.

As is apparent from the above description, in the venous valve prosthesis 100 of the present embodiment, since the sinus region 102 is formed on the venous valve holder 1, the presence of the sinus region 102 enables the backflow blood to form a vortex in the sinus region 102. When blood flows downstream, the pressure balance generated by the vortex flow based on the sinus region 102 can enable the valve 2 to be suspended in the channel 101 without being attached to the venous valve support 1 or the thin film 3 while the valve 2 is opening the channel 101, and the risk of failure caused by adhesion of the valve 22 is reduced. Also, when there is a backflow of blood, the valve 2 can be more easily caused to close the passage 101 by the blood flow impacting against the suspended leaflet 22 than by impacting against the venous valve stent 1 or the membrane 3.

Further, the stent body 11 of the venous valve stent 1 is a radially telescopic structure, has a small size before being implanted into the blood vessel 500, and has small surgical trauma. The stent body 11 adopts the support body 111 with a closed loop structure at two ends, has the advantages of high radial support force and strong anchoring force, can be reliably anchored on the inner wall of the blood vessel 500 after being implanted into the blood vessel 500, and can uniformly apply force to the intima of the blood vessel 500 in the circumferential direction, thereby relieving the stimulation to the intima of the blood vessel 500 and preventing the intima of the blood vessel 500 from excessively proliferating. The upright column 112 positioned in the middle of the support body 11 increases the axial rigidity of the venous valve support 1, so that the support body 11 part loading the valve 2 is not subjected to diameter change caused by factors such as muscle pump, pressure gradient change and the like. The whole venous valve support 1 structure presents larger rigidity, the venous valve support 1 always keeps a fixed shape after being implanted, and the valve body 21 of the valve 2 and the function of the valve leaf 22 are not influenced by the change of the transmural pressure of the blood vessel 500.

The sinus cavity frame 12 of the venous valve support 1 forms a sinus region 102 at the side of the support body 11, so that the structural advantage of fluid mechanics is formed, and blood does not generate thrombus at the valve 2. In particular, the sinus cavity shelf 12 is radially elastic with a design having a free end 1203, which may avoid over-stimulation of the blood vessel 500 by the sinus cavity shelf 12. And after being implanted into a human body, because the free end 1203 is suspended, the supporting body 111 which is closer to the near end than the sinus cavity frame 12 does not restrain the free end 1203, and the sinus cavity frame 12 can be more easily kept in a structural form which is convex to the bracket body 11, thereby maintaining the stability of the sinus region 102.

Meanwhile, the sinus stent 12 of the present embodiment is formed by connecting the first strut 121 and the second strut 122 to the stent body 11, and has a small number of structural members and a simple structure. In actual manufacturing, the stent body 11 and the sinus cavity stent 12 can be manufactured respectively and then connected into a whole, so that the manufacturing is convenient. In addition, the sinus cavity frame 12 is connected with the upright posts 112, and the sinus cavity frame 12 with a simple structure is matched with the upright posts 112 arranged at intervals, so that the venous valve support 1 also has a larger operation space for connecting the valve 2, the metal coverage rate is small, and the stimulation to the intima of the blood vessel 500 is effectively relieved.

It will be appreciated that in other configurations not shown, the sinus framework 12 is not limited to the configuration of the first strut 121 and the second strut 122 in this embodiment. Based on the utility model discloses a design, sinus cavity frame 12 only needs to satisfy following condition: one end of the sinus cavity stent is a fixed end fixedly connected with the stent body 11, the other end is a free end 1203 suspended outside the stent body 11, and the sinus cavity stent 12 protrudes out of the stent body 11 and forms a sinus region 102 inside. In this embodiment, the proximal end of the first support bar 121 and the proximal end of the second support bar 122 constitute a fixed end. In fact, since one end of the sinus cavity housing 12 is fixed and the other end is a free end, the overall structural shape of the sinus cavity housing 12 is not constrained by the stent body 11 or the fenestration 115 of the stent body 11, so that the structural form of the sinus cavity housing 12 can be flexibly set according to actual conditions, and the fabrication of the sinus cavity housing 12 and the connection with the stent body 11 are facilitated.

The venous valve stent 1 of the embodiment can be manufactured by nickel-titanium alloy laser engraving. In some embodiments, the total length L1 of the venous valve stent 1 (excluding the length of the visualization rod 1112) may be 15mm to 30mm, the diameter D1 of the support 111 may be 5mm to 30mm, and the sinus cavity stent 12 is located at a maximum diameter D2 that protrudes 2.5mm from the diameter D1 of the support 111.

The thickness of the rods of the venous valve support 1 can be designed to be 0.35mm, the width of each rod in the support body 111 can be designed to be 0.35mm, and the width of each rod in the upright post 112 and the sinus cavity stent 12 can be designed to be 0.6mm, so that the venous valve support 1 has better radial supporting force and axial rigidity.

A second embodiment, with reference to the structure shown in fig. 9-12.

The venous valve prosthesis 100a of the present embodiment differs from the first embodiment in that: the venous valve stent 1a of the venous valve prosthesis 100a has a plurality of sinus regions 102a, and in the present embodiment, there are two sinus regions 102 a. Correspondingly, the valve 2a is a bivalve structure. The membrane 3a covers the two sinus regions 102 a.

The venous valve stent 1a has two sinus cavity scaffolds 12a arranged oppositely, and the two sinus cavity scaffolds 12a respectively protrude outwards relative to the stent body 11a, so that the directions of the two sinus regions 102a are opposite.

The two valves 2a are sewn between the two sinus stents 12 a. The free edges 202a of the two valves 2a meet in the middle of the venous valve holder 1 a.

During the blood backflow, the two valves 2a are arched, and the free edges 202a of the two valves 2a are attached together to close the passage 101a, preventing the backflow blood from passing through. Vortices are formed in each sinus region 102a to encourage blood to return proximally and avoid blood accumulation.

As blood passes downstream, it impinges on the valve 2a, the free edges 202a of the two valves 2a separate, opening the channel 101a for blood to flow normally to the proximal end.

In this embodiment, the structure of the two sinus cavity frames 12a is adopted to effectively balance the open state of the valve 2a, and eddy currents are formed on both sides of the venous valve frame 1a, so as to avoid local thrombus caused by blood accumulation.

Compared with the four upright posts 112 of the first embodiment, in the present embodiment, one additional upright post 112a is arranged in the space between the two upright posts 112a which are not connected with the sinus cavity framework 12a, that is, the stent body 11a of the present embodiment has six upright posts 112a in total, which increases the radial supporting strength. Of course, the two more columns 112a may be omitted when the radial support strength is sufficient.

The second embodiment is illustrated by using a bivalve as an example, and based on the concept of the present invention, the venous valve prosthesis can further have three or more sinus regions, accordingly, the sinus cavity frame is correspondingly set to be three or more, and the valve is correspondingly of a three-valve and multi-valve structure.

A third embodiment, see the structure shown in fig. 13 and 14.

In this embodiment, which is a further extension of the second embodiment, in the venous valve prosthesis 100b of this embodiment, the venous valve stent 1b is provided with four sinus cavity scaffolds 12b, and the four sinus cavity scaffolds 12b are uniformly distributed along the circumferential direction of the venous valve stent 1b and are respectively arranged between two adjacent upright posts 112 a. Accordingly, four sinus regions 102b are formed in the venous valve holder 1 b. The number of valves 2b also corresponds to four, one arranged with respect to the sinus region 102 b.

A fourth embodiment, see the structure shown in fig. 15 and 16.

The venous valve prosthesis 100c of the present embodiment differs from that of the first embodiment in the structure of the sinus cavity scaffold 12c of the venous valve stent 1 c.

In this embodiment, the free end 1203c of the sinus cavity 12c is not bent toward the inside of the stent body 11c, but instead: the sinus stent 12c is divided into a first extension 1201c near the distal end and a second extension 1202c near the proximal end in the axial direction of the stent body 11c, and the distance from the first extension 1201c to the central axis L of the stent body 11c is gradually increased in the distal-to-proximal direction while the distance from the second extension 1202c to the central axis L is maintained.

In this embodiment, the free end 1203c of the sinus cavity shelf 12c still does not extend beyond the outermost side 1204c of the remaining portion of the sinus cavity shelf 12c except for the free end 1203c in the radial direction of the stent body 11 c.

The distance from the second extension segment 1202c to the central axis L remains unchanged, and when the venous valve prosthesis 100c is implanted into a human body vessel, local stress concentration of the vessel wall can be avoided through the second extension segment 1202c, pressure caused by outward protrusion of the sinus cavity stent 12c on the vessel wall is relieved, and excessive pressure borne by the vessel wall due to local stress concentration is avoided.

In the fifth embodiment, reference is made to the structure shown in fig. 17 and 18.

The venous valve prosthesis 100d of the present embodiment differs from the first embodiment in the structure of the sinus framework 12d of the venous valve stent 1 d.

In this embodiment, sinus framework 12d further includes a cross bar 123 d; the cross bar 123d extends along the circumferential direction of the holder body 11d, and both ends of the cross bar 123d are connected to the proximal end of the first rod 121d and the proximal end of the second rod 122d, respectively.

The cross bar 123d can increase the supporting area of the film 3d and ensure the firmness of the part of the film 3d covering the sinus region under the impact of the vortex. And the cross bar 123d can weaken the sharpness of the free end of the sinus stent 12d and can avoid damage to the vessel wall when implanted by increasing its lateral area.

A sixth embodiment, referring to the structure shown in fig. 19 to 21.

The venous valve prosthesis 100e of the present embodiment differs from the first embodiment in the connection position of the sinus cavity stent 12e and the stent body 11e in the venous valve stent 1 e.

In this embodiment, first strut 121e and second strut 122e of sinus framework 12e are not connected to the ends of post 112e, but rather are connected to the middle region of post 112 e.

Wherein the free end 1203e of the sinus framework 12e is spaced a distance S1 from the support 111e near the proximal end, and the proximal ends of the first and second struts 121e and 122e are spaced a distance S2 from the support 111e near the distal end, in this embodiment, S1 is equal to S2.

The seventh embodiment, refer to the structure shown in fig. 22 and 23.

The venous valve prosthesis 100f of the present embodiment differs from the first embodiment in the structure of the stent body 11f of the venous valve stent 1 f.

In this embodiment, the frame body 11f is an integral net frame, and the entire outer peripheral wall of the frame body is net-shaped, and does not have the pillar 112 as in the first embodiment. The side of the holder body 11f is notched in a substantially rectangular shape to form a window 115f, and the window 115f is located in a middle region of the holder body 11f in the axial direction of the holder body 11 f. The sinus shelf 12f is disposed at the fenestration 115 f.

The stent body 11f comprises a plurality of annular wavy rings 1111f, and the plurality of annular wavy rings 1111f are sequentially arranged along the axis of the stent body 11f and are axially connected to form a grid. And the fenestration 115f may be formed by cutting on the stent body 11 f.

The stent body 11f adopting the integrated net structure has better radial contraction and expansion performance. The fenestration 115f provided on the side of the stent body 11f can improve the overall compliance of the venous valve stent 1 f. The venous valve stent 1f may be bent at the fenestration 115f to enable it to more easily navigate tortuous complex vascular pathways, yet with greater flexibility than the first embodiment.

While the present invention has been described with reference to several exemplary embodiments, it is understood that the terminology used is intended to be in the nature of words of description and illustration, rather than of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.

Claims (24)

1. A venous valve stent, comprising:

the bracket body is of a hollow cylindrical structure and can radially extend and retract; the side part of the bracket body is provided with a window;

a sinus cavity shelf having opposite fixed and free ends; the fixed end is connected to the windowing part; the free end is suspended outside the bracket body; the inner side of the sinus cavity frame forms a sinus region which is communicated with the interior of the bracket body through the windowing.

2. The venous valve stent of claim 1, wherein the free end does not extend beyond an outermost side of a remainder of the sinus cavity stent other than the free end in a radial direction of the stent body.

3. The venous valve stent of claim 2, wherein the sinus cavity stent comprises a first extension and a second extension in a direction from the fixed end to the free end along the axial direction of the stent body, the first extension being gradually greater in distance from a central axis of the stent body; the joint of the first extension section and the second extension section is the outermost side of the sinus cavity frame, and the tail end of the second extension section is the free end.

4. The venous valve stent of claim 3, wherein the second extension gradually decreases in distance from the central axis of the stent body in a direction from the outermost side to the free end.

5. The venous valve stent of claim 4, wherein the distance from the second extension to the central axis of the stent body decreases at a progressively greater rate in a direction from the outermost side to the free end.

6. The venous valve stent of claim 4, wherein the second extension segment extends linearly.

7. The venous valve stent of claim 3, wherein the distance from the second extension segment to the central axis of the stent body remains constant.

8. The venous valve stent of claim 3, wherein the rate of increase of the distance from the first extension to the central axis of the stent body decreases in a direction from the fixed end to the outermost side.

9. The venous valve stent of claim 3, wherein the first extension segment extends linearly.

10. The venous valve stent of claim 1, wherein the sinus cavity stent comprises a first strut and a second strut; the first end of the first supporting rod is separated from the first end of the second supporting rod and is used as the fixed end to be connected to the windowing part respectively; the second end of the first strut is connected to the second end of the second strut and forms the free end.

11. The venous valve stent of claim 10, wherein the second end of the first strut and the second end of the second strut are directly connected.

12. The venous valve stent of claim 10, wherein the sinus cavity stent further comprises a cross bar; the cross rod extends along the circumferential direction of the support body, and two ends of the cross rod are respectively connected with the second end of the first supporting rod and the second end of the second supporting rod.

13. The venous valve stent of claim 10, wherein the first strut and the second strut are progressively closer to each other in a direction along the first end to the second end.

14. The venous valve stent of claim 13, wherein the angle between the first strut and the second strut is between 30 ° and 90 °.

15. The venous valve stent of claim 13, wherein the first strut and the second strut are symmetrical.

16. The venous valve stent of any of claims 1-15, wherein the fenestration is located in an axially central region of the stent body.

17. The venous valve stent of claim 16, wherein the sinus stent has a length in the axial direction of the stent body that is greater than half of a length of the fenestration in the axial direction of the stent body.

18. The venous valve holder of claim 16, wherein the holder body comprises two support bodies spaced apart and a plurality of posts connected between the two support bodies; the support body is in a cylindrical shape with a circumferential closed loop; the two support bodies are coaxially arranged and are opposite to each other at intervals along the axial direction; a plurality of said posts are circumferentially spaced about a central axis of said support body;

the window is formed in the interval between two adjacent upright posts.

19. The venous valve stent of claim 18, wherein the support body comprises a plurality of undulating rings that are axially contiguous; each wave ring is provided with a wave crest and a wave trough which are staggered along the circumferential direction, and the wave crests and the wave troughs of two adjacent wave rings are connected to form a grid shape; the upright post is connected with the opposite wave crests and wave troughs of the two supporting bodies.

20. The venous valve stent of claim 18, wherein the post is linear and extends in an axial direction of the stent body.

21. The venous valve holder of claim 16, wherein the holder body is a unitary structure having a mesh-like outer peripheral wall with the fenestrations formed therein.

22. The venous valve stent of any of claims 1-15, wherein the fenestrations are a plurality of in number, distributed circumferentially along the stent body; the sinus cavity frame is provided with a plurality of sinuses frames which are connected with the windowing part in a one-to-one correspondence mode.

23. A venous valve prosthesis comprising a valve and a venous valve holder as claimed in any of claims 1 to 22; the valve is fixed in the stent body and covers at least a partial area of the sinus region; the valve has a free edge on a side of the valve facing away from the sinus region.

24. The venous valve prosthesis of claim 23, further comprising a membrane covering the entire peripheral wall of the venous valve stent.

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