WO2019196845A1 - 一种静脉瓣置换装置 - Google Patents

一种静脉瓣置换装置 Download PDF

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Publication number
WO2019196845A1
WO2019196845A1 PCT/CN2019/081973 CN2019081973W WO2019196845A1 WO 2019196845 A1 WO2019196845 A1 WO 2019196845A1 CN 2019081973 W CN2019081973 W CN 2019081973W WO 2019196845 A1 WO2019196845 A1 WO 2019196845A1
Authority
WO
WIPO (PCT)
Prior art keywords
replacement device
valve replacement
edge
venous valve
leaflets
Prior art date
Application number
PCT/CN2019/081973
Other languages
English (en)
French (fr)
Inventor
郭伟
王永胜
李建民
丘家明
Original Assignee
倍芮医疗器械（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 倍芮医疗器械（上海）有限公司 filed Critical 倍芮医疗器械（上海）有限公司
Priority to US17/046,086 priority Critical patent/US11478352B2/en
Priority to EP19785321.1A priority patent/EP3777767A4/en
Publication of WO2019196845A1 publication Critical patent/WO2019196845A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2469—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with resilient valve members, e.g. conical spiral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2475—Venous valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • the present application relates to the field of medical device technology, and in particular to a venous valve replacement device that can be placed into the body by intervention to improve venous return.
  • leaflets In order to alleviate and treat venous reflux, various structures and methods of use of artificial venous valves are disclosed in the prior art. Some products have complex structures and poor reliability, and some products use relatively simple mesh tubular stents combined with petals. In the form of leaves, the form of leaflets is usually a single leaf, two leaf or three leaf.
  • the venous blood flow rate is slow, and the opening and closing of the valve leaflets needs to be extraordinarily sensitive.
  • the trilobes are difficult to satisfy in this respect, and the main problem of the single leaf and the second leaf valve is that it is difficult to balance the open area and sealing of the channel.
  • the present application provides a venous valve replacement device, which can improve the structure of the existing problems on the basis of sensitive opening and closing of the two leaflets, and obtains a good sealing property.
  • a venous valve replacement device includes a stent with a blood flow channel and two leaflets attached to the stent, one side of each leaflet being a fixed edge connected to the stent, and the other side being a mutual fit for opening and closing
  • the active edge of the blood flow channel, the flaps of the two leaflets are provided with flaps that abut each other in a closed state.
  • the stent used in the present application can utilize the prior art, has a cylindrical structure to adapt to the shape of the venous lumen, and the cylindrical structure does not need to be a complete cylinder, at least provides a support ring supported in the venous lumen and Fix the corresponding support structure of the edge shape.
  • the stent is constructed of a radially compressible mesh structure, such as by weaving or cutting.
  • the mesh structure may adopt a regular distributed or irregular unit structure.
  • the material of the leaflet itself can utilize the prior art, for example, a biofilm such as a porcine pericardium or a bovine pericardium, and the leaflets are fixed on the stent by means of stitching, etc.
  • the improvement of the present application focuses on the use of two-leaf petals.
  • the shape of the leaflets, the active edge of the two leaflets form a one-way valve structure, open under the action of normal venous blood flow (hereinafter referred to as blood flow), but when the blood pressure gap changes, in order to prevent venous return, two flaps
  • blood flow normal venous blood flow
  • two flaps The active edges of the leaves are sealed against each other and closed during the closing process.
  • the two flaps that cooperate with each other will have a more pronounced tendency to close each other under the action of the returning blood, so that the leaflets of the traction are moved toward the other leaflet to realize two flaps.
  • the fit of the leaf active edge is closed.
  • the mutually cooperating two flaps abut each other and have a large contact area, and the other portions are only attached to the edge regions with respect to the active edge, and the two flaps have a better locking effect.
  • the sealing effect is further guaranteed.
  • the flap is integral with the leaflet in which it is located.
  • the fin protrudes from the active edge where it is located.
  • the active edge is a continuously extending curve as a whole, and there is a sudden change in the local extension tendency at the wing portion. Since the flap is required to guide the leaflet to close and lock, the overall tendency of the flap is convex. Active edge.
  • the fin has an area of 0.1 to 10 square millimeters, further preferably 4 square millimeters to 6 square millimeters.
  • the shape of the fixed edge is a parabola, and the apex is upstream of the downstream direction of the blood, and gradually extends downstream from the apex on both sides.
  • the fins should have a certain area to play a corresponding guiding role, but the excessively large area will bring additional resistance to the opening of the movable edge, which will reduce the sensitivity of the one-way valve opening.
  • the fins on the two leaflets are matched in position and in the same shape.
  • the mating fins on the two leaflets are not required to be consistent in position, and the misalignment is allowed. However, if the locking and closing action is required, the two at least partially abut each other, or even local deformation. Wrap each other.
  • the middle portion of the movable edge is convex toward the side of the fixed edge or raised toward the side of the fixed edge, and the apex of the convex portion is the apex of the movable edge.
  • the fixing edge and the inner edge are fixedly fitted together, in combination with the characteristics of the two leaflets, the fixing edge is generally parabolic in shape, and the central portion of the movable edge is oriented toward or away from the fixed edge.
  • the central portion of the arc is curved, and the orientation of the top of the arc can be regarded as a convex orientation.
  • the length of the two movable edges can be appropriately increased by an arc shape, and the cross-sectional area of the passage is increased when opening.
  • the two flaps are respectively located on opposite sides of the apex of the movable edge.
  • At least one piece of the flap on the active edge of each leaflet may be appropriately increased in order to improve the corresponding effect.
  • two flaps are arranged on the active edge of each leaflet, in order to improve the closure.
  • the position of the airfoil should avoid the middle area of the active edge, and the middle finger should be in the middle of the extending direction of the active edge.
  • the active edge is a curve, and the middle part is understood as the vicinity of the midpoint of the curve.
  • the two fins are symmetrically distributed on either side of the apex of the active edge.
  • the symmetrical distribution of the two flaps makes the tension of the two sides more consistent. If one side is closed first, it may cause the other side to deform seriously under the action of blood flow and affect the closing effect.
  • the two leaflets are a unitary structure.
  • the one-piece structure can cut two leaflets at one time, and then merge into a cylindrical shape and sew on the bracket.
  • the active edge is in a two-dimensional plane.
  • the projected shape of the movable edge along the axial direction of the bracket is a straight line segment.
  • the active edge intersection of the two leaflets in the closed state passes through the stent axis or off the stent axis.
  • the middle portion of the fixing edge faces away from the movable edge protrusion, and the apex of the convex portion in the middle portion of the fixed edge is the apex of the fixed edge, and the apex of the convex portion in the middle of the movable edge is the apex of the movable edge.
  • the fixed edge and the active edge are all similar to a parabola as a whole, and the vertices of the central portion are substantially the respective midpoints.
  • the direction of the apex of the movable edge may be oriented as described above or facing away from the fixed edge.
  • the line connecting the apex of the active edge and the apex of the fixed edge is a leaflet center line.
  • each leaflet a symmetrical structure is preferred, and the centerline of the leaflet is the axis of symmetry of the leaflet shape.
  • each set of threading holes is 3 to 10.
  • the movable edge and the fixed edge are gradually close together at a position on the same side of the center line of the leaflet and are connected by a slat piece, and the sipe is fixed to the bracket.
  • the sewed piece is used to strengthen the tip end portion of the leaflet, that is, the intersection of the fixed edge and the movable edge, and the sewed piece is also more convenient to be sewed on the bracket, and the shape of the sewed piece is not strictly limited, and generally can be located at a position
  • the cell shape corresponds to exactly the corresponding cell and is sewn to the support strip around the cell.
  • the angle between the centerline of the leaflet and the axis of the stent in the closed state is 30 to 60 degrees. It is preferably 30 to 45 degrees.
  • the angle between the centerline of the leaflet and the axis of the stent generally reflects the angle between the two leaflets in the closed state, and the angle affects the sensitivity of the opening and closing of the leaflet.
  • the angle between the centerline of the leaflet and the axis of the stent is too large.
  • the angle is close to 90 degrees, it can be considered that the two leaflets are almost coplanar, which makes the opening of the active edge require a stronger blood flow impact, and is not easy to form a larger one.
  • the open area it is obvious that venous blood with a slower flow rate is difficult to meet this requirement.
  • the fixed edge and the active edge of the leaflet will extend in the axial direction for a long distance, and the opening and closing will allow a large deformation, but it will cause the deformation of the deformation variable to be too bad. influences.
  • the active edge is provided with a slit for increasing the relative degree of freedom adjacent to the patch.
  • the edge of the activity When the edge of the activity extends to the end (the end away from the top end of the active edge), it is engaged with the slatted piece. Since the slat is fixed on the bracket, the degree of freedom of the active edge, ie the bounding edge, is affected, and the movable edge movement is reduced by the slit. The degree of association with the sewed patch can improve and improve the flexibility of the opening and closing of the active edge.
  • the edge of the slit is a smooth curve.
  • the edge is a smooth curve that avoids local stress concentrations and reduces the risk of tearing when stretched.
  • the active edge includes a mouth segment located near the apex of the active edge, and a guiding segment located at two sides of the mouth segment; the radial expansion rate of the mouth segment is V1, and the radial direction of the guiding segment The expansion rate is V2, and V1 is greater than V2;
  • the radial outward expansion rate is the amount of change in the radial position when the unit distance is extended along the axial direction of the stent.
  • the mouth-forming section is relatively straight (the extension trend is closer to the radial direction of the bracket), which can improve the opening and closing speed and sensitivity.
  • the guiding section is longer and steeper (the extension trend is closer to the axial direction of the bracket).
  • the larger opening area, and more importantly, the closed state, can be closer to the inner wall of the stent to avoid local blood accumulation and thrombosis.
  • V1 is 4 to 20 times that of V2.
  • the span of the mouth segment in the radial direction of the stent accounts for at least 2/3 of the diameter of the stent at the position of the leaflet.
  • the mouth-forming section has a sufficient length in the radial direction to ensure a large opening area.
  • the fin is located at the junction of the mouth segment and the guiding segment.
  • the wing piece can also be regarded as a mutation part of the active edge extension trend, and one side is a mouth part.
  • one side is a mouth part.
  • the distance between the airfoil and the apex of the active edge is 1/10 to 1/2 of the active edge span.
  • the proper position of the airfoil ensures the sealing effect of the movable edge. Overall, the distance of the airfoil from the center line of the active edge to the apex of the movable edge is closer than the distance to the end of the active edge, and the effect of closing the lock can be effectively exerted.
  • the active edge is in a two-dimensional plane.
  • the length of the movable edge is increased, resulting in a radial span larger than the active edge after closing, and thus exhibiting a reciprocating bending state after closing, that is, the active edge is in a three-dimensional space.
  • the inner extension in the present application, can ensure the opening area by the steep guiding section, and avoid forming a three-dimensional reciprocating bending structure in the mouth forming section.
  • the projected shape of the movable edge along the axial direction of the bracket is a straight line segment.
  • the active edge intersection of the two leaflets in the closed state passes through the stent axis or off the stent axis.
  • the intersecting line of the active edges of the two leaflets in the closed state passes through the axis of the stent. If the shape or size of the two leaflets are different, that is, the asymmetric distribution, the active edges of the two leaflets in the closed state The intersection line does not pass through the axis of the support.
  • the mouth-forming segment in the expanded state of the leaflets, extends along a straight line, or the middle portion of the mouth-forming segment is convex toward the apex of the fixed edge or protrudes toward the apex of the fixed edge;
  • the central convex direction of the mouth forming section is the same or different.
  • the mouth segments in the two leaflets completely coincide or only partially intersect.
  • the mouth portion and the guiding portion are connected by an S-shaped edge, and the S shape includes a first arc edge and a second arc edge that are connected to each other and face opposite;
  • the first arc edge is engaged with the guiding segment, and the area surrounded by the first arc edge is the fin, and the vertex of the first arc edge is the apex of the fin;
  • the second arc edge is engaged with the mouth segment, and the apex of the second arc edge is the end of the mouth segment.
  • the distance between the apex of the flap and the end of the segment is 0.5 to 0.7 mm in the direction of the centerline of the leaflet.
  • a suitable shape can fully exert the effect of the airfoil, the apex of the second arc edge is generally radially outward along the bracket, and can further increase the radial span of the mouth segment, and the S-shaped meandering makes the corresponding leaflet of the guiding segment Appropriately increase the width of the site to improve guiding and anti-thrombosis effects.
  • the first arc edge and the second arc edge are respectively a partial area of a circle or an ellipse, the radius of the circle is 0.2-0.8 mm, and the semi-major axis of the ellipse is 0.2-0.8 mm.
  • the shape of the arc edge, especially the first arc edge corresponds to the outer contour shape of the airfoil, and the present application also preferably optimizes the shape and the size range thereof, and the shape of the end portion of the flap and the mouth portion is synergistic, and the mouth can be taken into consideration.
  • the opening area of the segment and the closure guiding action of the flap is synergistic, and the mouth can be taken into consideration.
  • the apex of the fin is directed to the centerline of the leaflet.
  • the mouth segments of the active edges of the two leaflets are completely separated.
  • the movable edge in the closed state, extends from the apex of the movable edge to the downstream of the blood flow, and extends away from the apex of the movable edge in the radial direction of the bracket.
  • the length of the guiding section in the axial direction of the bracket is 1/3 to 3 times of the diameter of the bracket.
  • the guiding section is of sufficient length to have sufficient radial deformation to abut against the inside of the stent to avoid thrombus, and the diameter of the stent can be adjusted according to the diameter of the venous vessel, so that the axial length of the guiding section and the diameter of the stent have The corresponding proportional relationship.
  • the leaflet includes a middle portion corresponding to the position of the mouthpiece segment and a side portion corresponding to the position of the guiding segment, and in the closed state, the side portion is adjacent to the inner side wall of the adjacent bracket.
  • the side is close to the inner side wall of the adjacent bracket, and the blood at the side and the inner side of the stent can be pushed out to the maximum extent when the leaflets are closed, so as to avoid residual thrombosis.
  • the span of the active edge in the axial direction of the stent is greater than 0.5 times, more preferably 0.6 to 3 times the diameter of the stent at the position of the leaflet.
  • the cross-sectional area of the blood flow channel in the open state is at least 70% of the cross-sectional area of the stent at the leaflet position.
  • the inner wall of the bracket is further provided with a film.
  • the membrane can construct a blood flow channel and improve the flow control effect of the leaflets.
  • the membrane itself can be made of materials in the prior art, and the leaflets can be the same or different materials.
  • the coating is cylindrical and is located on the upstream side of the leaflet, and the coating is engaged with the fixed edge of each leaflet toward the end of the leaflet to construct a blood flow channel.
  • the covering film is spaced apart from the edge of one end of the leaflet and is provided with a plurality of cutting regions.
  • Radial compression of the stent is more advantageous by cutting a portion of the area.
  • the cutting zone is triangular or trapezoidal, semi-circular, or the like.
  • the two leaflets have different radial spans, the radial span is larger than the large leaflets, and the radial span is smaller than the small leaflets.
  • the active edge intersection lines of the two leaflets are offset from the stent.
  • the projected shape of the intersection of the movable edges of the two leaflets in the closed state along the axial direction of the stent is a straight section, and the direction spanned by the radial span is perpendicular to the straight section.
  • a ratio of a projected area of the small leaflet to the large leaflet along the axial direction of the stent is 0.15 to 0.8:1.
  • a ratio of a radial span of the small leaflet to the large leaflet is 0.2 to 0.9:1.
  • a ratio of a radial span of the small leaflet to the large leaflet is 0.3 to 0.6:1.
  • the projected shape of the intersecting line of the movable edge of the two leaflets in the closed state is a straight line segment, and the straight line segment and the diameter of the bracket satisfy: 0.6D ⁇ F ⁇ 1D;
  • F is the length of the straight line segment
  • D is the diameter of the bracket and the axial position corresponding to the diameter is the same as the axial position of the end point of the straight line segment.
  • the straight line segment and the diameter of the bracket satisfy: 0.7D ⁇ F ⁇ 0.95D.
  • the two leaflets have different axial spans along the axial direction of the bracket.
  • the middle portion of the fixing edge faces away from the movable edge protrusion, and the apex of the convex portion in the middle portion of the fixing edge is the apex of the fixed edge; the projection position of the fixed edge apex of the two leaflets on the axis of the bracket Do not coincide.
  • the ratio of the axial span of the small leaflet to the large leaflet is 0.4 to 0.95:1.
  • the ratio of the axial span of the small leaflet to the large leaflet is 0.6 to 0.8:1.
  • the two leaflets have different radial spans, the radial span is larger than the large leaflets, and the radial span is smaller than the small leaflets.
  • the active edge intersection lines of the two leaflets are offset from the stent.
  • An axis; in the closed state, the projected edge of the movable edge of the two leaflets along the axial direction of the stent is a straight line segment, and the direction spanned by the radial span is perpendicular to the straight line segment;
  • the apex of the fixed edge of the large leaflet is upstream, and the apex of the fixed edge of the small leaflet is downstream.
  • the projection apex of the two leaflets has a projection position distance K on the axis of the stent, the diameter of the stent is D, and the ratio of K to D is 1/4 to 1/3.
  • the brackets in the prior art are formed by staggered support strips. When the leaflets are fixed, the fixed edges are sewn on the corresponding support strips by the sutures, and the position and uniformity of the stitches are controlled to have high professional requirements. The relative position on the bracket also needs to be corrected frequently during the sewing process, which increases the difficulty of operation.
  • the bracket itself has a certain gap between adjacent support bars, but the arrangement of the gap is related to the arrangement of the support bars and the shape of the mesh, and is generally larger, although the seams can be threaded in the gaps, but the seams are The position of the line is not fixed.
  • the bracket is arranged with a threading hole for connecting the fixing edge of the leaflet.
  • the hole diameter of the threading hole is relatively small, and there is little slippage after the thread is passed through.
  • the threading hole can be arranged by using the width of the support bar and processing the threading hole in the width range, and more importantly, the arrangement of the threading hole. Corresponding to the direction of the fixed edge, sewing the fixing edge point by point along the extending direction of the threading hole can greatly reduce the operation difficulty, improve the processing efficiency, and reduce the defective rate.
  • the bracket is provided with two V-shaped fixing strips, and the threading holes are distributed at corresponding positions of the fixing strips;
  • the apex of the V-shape points to the downstream of the bloodstream in the state of use, and the two sides of the fixed edge of the same leaflet are sewn on different fixed strips.
  • the V-shaped fixing strip comprises two fixing rods;
  • the two fixing rods are relatively inclined, and the two fixing rods in the same fixing strip respectively correspond to different one leaflets.
  • the two fixing rods meet at the vertices of the V shape or each extend up to the apex of the V shape.
  • each of the fixing rods is disposed obliquely to the axis of the bracket.
  • the bracket is formed by interlacing a plurality of support strips, wherein some of the support strips are partially widened, and the fixing rod is formed at a widening portion, and the threading holes are divided into several groups, and the same group of threading holes are arranged. On one of the poles.
  • the extending direction of the single support strip is not completely consistent with the extending direction of the fixed edge. Therefore, for the fixed edge of the same leaflet, the corresponding threading hole can be divided into several groups that are sequentially connected, and the corresponding group is in accordance with the fixed edge. Distributed on different support strips, the extension direction without obvious mutation or obvious turning can be regarded as the same support strip.
  • the support strip is widened at least at a portion where the threading hole is disposed.
  • the fixing rod extends in equal width.
  • the widened portion of the support strip has a width of 2 to 5 mm.
  • the threading hole requires a certain aperture to pass the needle thread, the corresponding portion of the support strip in which the threading hole is disposed can be set as needed, and the threading hole itself can be provided with an aperture according to a commonly used needle or wire.
  • the threading hole is a round hole or an elliptical hole.
  • the threading hole has a smooth inner edge for threading, and the threading holes of the same supporting strip can be evenly spaced, or can be adjusted according to the extending direction of the fixing edge.
  • the bracket is a mesh structure, and the same set of threading holes extends from 2 to 6 cells.
  • the two V-shaped fixing strips are arranged at intervals in the circumferential direction of the bracket.
  • the two V-shaped fixing strips are symmetrically distributed on both sides of the bracket axis.
  • the V-shaped vertex of the two V-shaped fixing strips is connected as a reference line; in a viewing angle along the axial direction of the bracket, the reference line is offset from the axis of the bracket.
  • the reference line and the diameter of the bracket satisfy: 0.6D ⁇ E ⁇ 1D;
  • E is the length of the reference line
  • D is the diameter of the bracket and the axial position corresponding to the diameter is the same as the axial position of the V-shaped apex.
  • the reference line and the diameter of the bracket satisfy: 0.7D ⁇ E ⁇ 0.95D.
  • the two fixing rods in the same fixing strip are not equal in length.
  • the two fixing rods in the same fixing strip are different from the axial direction of the bracket.
  • the two fixing rods in the same fixing strip extend substantially in a straight line, and the angle between the two fixing rods is greater than 0 degrees and less than or equal to 60 degrees.
  • the venous valve replacement device of the present application improves the sealing property by increasing the flap at the active edge, and further enlarges the opening area by the shape of the movable edge to ensure smooth blood flow, and also avoids the formation of local thrombus, thereby improving safety.
  • FIG. 1 is a schematic structural view of a venous valve replacement device of the present application in a closed state, in which a bracket is omitted and a relative position is indicated by a broken line frame;
  • FIG. 2 is a schematic structural view of the venous valve replacement device of FIG. 1 in an open state
  • FIG. 3 is a schematic view showing the unfolded state of the leaflets in the venous valve replacement device of the present application
  • Figure 4 is a schematic view of the leaflet of Figure 3 together with the stent film
  • Figure 5 is a schematic view showing the structure of a closed state of a venous valve replacement device in a pair
  • FIG. 6 is a schematic structural view of the venous valve replacement device of FIG. 5 in an open state
  • FIG. 7 is a schematic structural view showing a closed state of a venous valve replacement device in another comparative example
  • Figure 8 is a partial schematic view of the leaflets of Figure 3.
  • FIG. 9a are schematic diagrams showing the intersection of active edges in a closed state in different embodiments.
  • Figure 10 is a schematic view showing the expanded state of the leaflets in one embodiment
  • 11a-11d is a schematic view showing a state in which two leaflets are flattened in different embodiments
  • Figure 12 is a schematic view showing the structure of two leaflets in an embodiment in an axial viewing angle
  • FIG. 13b is a schematic view showing the structure of the closed and open state of the two leaflets along the angle of intersection of the movable edges in the symmetric embodiment of the leaflets;
  • 14a to 14d are schematic views showing the structure of the two leaflets at different viewing angles and states in an asymmetric embodiment of the leaflets;
  • FIG. 15a is a schematic view showing the structure of the closed and open state of the two leaflets along the angle of intersection of the movable edges in another embodiment in which the leaflets are asymmetric;
  • FIG. 16a to FIG. 16d are different parts of the stent. Schematic diagram of the structure at different viewing angles;
  • 17a to 17d are schematic structural views of a venous valve replacement device at different viewing angles in different embodiments
  • 18a to 18c are schematic views showing the distribution of the fixing strips on the venous valve replacement device in the symmetrical embodiment of the leaflets;
  • 19a to 19c are schematic diagrams showing the distribution of the fixing strips on the venous valve replacement device in the asymmetric embodiment of the leaflets;
  • 20a-20c are schematic views showing the distribution of the fixing strips on the venous valve replacement device in another embodiment in which the leaflets are asymmetric.
  • a component when referred to as being "connected” to another component, it can be directly connected to the other component or the component can be present. When a component is considered to be “set to” another component, it can be placed directly on another component or possibly with a centered component.
  • a venous valve replacement device including a stent 1 with a blood flow channel and two leaflets 3 connected to the stent 1, each leaflet 3
  • the side is a fixed edge 31 connected to the bracket 1 and the other side is a movable edge 32 which cooperates with each other for opening and closing the blood flow passage, and the movable edge 32 of the two leaflets 3 is provided with a flap which abuts against each other in a closed state. 33.
  • the flaps in the various embodiments of the present application are clearly convex at the edges of the active edge, and are not embodied in wrinkles or other specific viewing angles.
  • the stent 1 is generally a mesh tube structure, which is processed by weaving or cutting and can be radially compressed, so as to be loaded into the conveying device, and is delivered to the designated position of the venous blood vessel by an interventional method, and the stent 1 supports the inner wall of the venous blood vessel.
  • the support 1 is provided with two leaflets 3, and one side of each leaflet is a fixed edge 31 connected to the bracket 1.
  • the fixed edge 31 is substantially parabolic, and the fixed edge 31 is fixed on the inner side of the bracket by means of stitching.
  • the stent 1 can also be in a simplified form, including only an annular portion that supports the inner wall of the venous vessel, and a support frame that is coupled to the annular portion and that corresponds to the shape of the two lobes.
  • the annular portion may also extend slightly in the axial direction, and the extension distance is equivalent to the axial dimension of the film 2.
  • the support frame bracket or indirectly (through the connecting rod) is connected to the annular portion.
  • each leaflet is a movable edge 32 that cooperates with each other to open and close the blood flow channel.
  • the venous blood flows in the direction of arrow B, and the active edge of the two leaflets is separated under the action of blood flow, that is, open blood flow.
  • the two leaflets are closed under the action of the arrow A in the direction of the reflux blood, and the two movable edges are fitted to each other to prevent further venous return.
  • the inner side of the bracket 1 is further provided with a coating 2, the top edge of the coating 2 is engaged with the fixing edge 31 of the leaflet 3, and the bottom edge is provided with a plurality of triangular cutting zones.
  • the film 2 is surrounded by a cylinder and is joined by seams at the joint portion by seams 21.
  • the flap 33 and the leaflet 3 in which it is located may be of a separate or unitary structure.
  • the two leaflets may be either a split structure or a unitary structure.
  • the tabs 33 are raised from the active edge 32 where they are located.
  • the overlapping of the fins on the two leaflets can increase the contact area and ensure the sealing effect.
  • the shape of the leaflet 3 is correspondingly improved.
  • the central portion of the fixed edge 31 in the flattened state of the leaflet 3, is convex toward the movable edge, and the central portion of the fixed edge is raised.
  • the apex of the fixed edge is the fixed edge vertex M2
  • the middle of the movable edge is convex toward the fixed edge side
  • the vertex of the convex portion is the active edge vertex M1.
  • the overall shape of the fixed edge is a parabola, and the apex of the fixed edge is upstream of the downstream direction of the blood, and gradually extends downstream from both sides of the fixed edge.
  • the fixed edge and the stent are closed at all places.
  • a substantially symmetrical structure is employed, for example the line connecting the active edge vertex M1 to the fixed edge vertex M2 is the leaflet centerline L1; the leaflet 3 is relative to the leaflet centerline L1 It is generally a symmetrical structure.
  • the angle between the leaflet centerline L1 and the stent axis L2 in the closed state, is 30 to 60 degrees. In a preferred embodiment, the angle between the leaflet centerline L1 and the stent axis L2 is 30. ⁇ 45 degrees. In the closed state, the angle between the leaflet centerline L1 and the stent axis L2 substantially reflects the angle between the two leaflets in the closed state, and the angle affects the sensitivity of the leaflet opening and closing.
  • the movable edge 32 In the closed state, the movable edge 32 extends from the apex of the movable edge toward the downstream of the blood flow, and extends away from the apex of the movable edge along the radial direction of the stent, in order to further ensure that the leaflet opening has sufficient area, one of them
  • the span of the active edge 32 in the axial direction of the stent is greater than 0.5 times the diameter of the stent at the position of the leaflets.
  • a plurality of fins may be arranged on each leaflet, for example, 2 to 4, and generally may be divided into two groups on both sides of the leaflet center line L1.
  • the two flaps 33 are symmetrically distributed about the leaflet centerline L1.
  • the mating flaps on the two leaflets are not strictly limited in size or the same, at least to ensure that the partial regions can overlap one another in the closed state, in a preferred embodiment the flaps on the two leaflets are identical in structure and closed.
  • the time position corresponds.
  • the same structure of the fins can be regarded as substantially matching the shape and size. In the ideal overlapping state, the edges of the two are aligned.
  • the embodiment does not require strict consistency, for example, 80% of a certain flap. The area fits the other matching wing.
  • the position of the flap 33 also has an influence on the sensitivity of the opening and the sealing effect.
  • the flap 33 and the active edge The distance from the apex is 1/10 to 1/2 of the active edge span. That is, the flap 33 is closer to the apex of the active edge over the overall span of the active edge.
  • the movable edge 32 and the fixed edge 31 is gradually close to the same side of the leaflet center line L1 and is connected by the patch piece 36, and the patch piece 36 is fixed to the bracket 1.
  • the movable edge 32 can be smoothly curved from the flap 33 until it extends to the vicinity of the inner side of the bracket 1, but in order to improve the flexible opening and closing of the leaflet on the side of the movable edge 32, in one embodiment, the movable edge 32 is adjacent to the slit patch.
  • the portion of 36 is provided with a slit 37 for increasing the relative degree of freedom.
  • the edge of the slit 37 is a smooth curve, and the slit 37 can reduce the restraint of the movable edge 32 by the seam patch 36, thereby improving and improving the flexibility of opening and closing the movable edge 32. .
  • the active edge 32 includes a mouthed section 34 located adjacent the apex M1 of the active edge, and a guide section 35 located on either side of the mouthed section 34.
  • the vertical line H relative to the centerline L1 of the leaflet can be seen.
  • the mouth-forming section 34 is relatively straight, which can improve the opening and closing speed and sensitivity.
  • the guiding sections 35 on both sides can be matched with the synthetic section 34 to obtain a comparison.
  • the large opening area can be closer to the inner wall of the stent in the closed state, avoiding the accumulation of blood in the region C between the top of the guiding section and the stent to form a thrombus.
  • the radial expansion rate of the mouth segment 34 is V1
  • the radial outward expansion rate of the guiding segment 35 is V2
  • V1 is greater than V2, for example, in different In an embodiment, V1 is 4 to 20 times V2.
  • the radial outward expansion rate is the amount of change in the radial position when the unit distance is extended along the axial direction of the bracket, and the radial expansion rate is larger, that is, the larger the component of the radial extension, the overall trend is more straight.
  • the guiding section 35 is of sufficient length to have sufficient radial deformation to abut against the inside of the stent to avoid thrombus.
  • the length of the guiding section 35 in the axial direction of the stent is 1/3 to 3 of the diameter of the stent. Times.
  • the mouth portion 43 has a sufficient length in the radial direction to ensure a large opening area.
  • the span of the mouth portion 34 in the radial direction of the bracket occupies at least 2 of the diameter of the bracket at the position of the leaflet. /3.
  • the mouth segments 34 of the two leaflets are completely separated, and the cross-sectional area of the blood flow channel is at least 80% of the cross-sectional area of the stent at the position of the leaflets, at least 70%.
  • the periphery of the blood flow channel is surrounded by the active edge.
  • the active edges of the two leaflets should have sufficient length in the direction of their extension.
  • the cross-sectional area of the blood flow channel can be set to 100% of the cross-sectional area of the stent at the position of the leaflet.
  • the length of the active edge in its own extension direction is 1.4 times the diameter of the stent to half the circumference of the stent.
  • the cross-sectional area of the blood flow channel is generally slightly smaller than the cross-sectional area of the stent.
  • the stent is enlarged in diameter at the suture portion of the leaflet, so that the thickened region can be avoided as much as possible to ensure a sufficient cross-sectional area of the blood flow passage.
  • the movable edge 32 in some two-lobed structure in other fields in the prior art, is relatively straight as a whole to facilitate the tightening and closing, but is closed on the upstream side of the blood flow.
  • the area C between the leaflet 3 and the stent 1 is large, and it is easy to accumulate blood to form a thrombus.
  • the active edge is relatively straight, it is difficult to form a blood flow channel having a large cross-sectional area after opening.
  • Fig. 7 in order to ensure the opening area, although the movable edge 32 can be lengthened, a bend is formed after closing, causing partial separation of the two leaflets, which affects the sealing property.
  • the movable edge 32 in the closed state, is in a two-dimensional plane.
  • a preferred embodiment is that in the closed state, the projected shape of the movable edge along the axial direction of the bracket is a straight line segment, which avoids bending in three dimensions.
  • the inside of the stent 1 is respectively provided with a leaflet 3a and a leaflet 3b.
  • the movable edges of the two leaflets are fitted to each other to close the blood flow passage, and the portions which adhere to each other along the axial direction of the stent are the active edge intersection line 3c.
  • the active edge intersection line 3c is a straight line segment.
  • the movable edge intersection line 3c in the closed state passes through the stent axis, and can also be regarded as the movable edge intersection line 3c as the diameter of the stent 1.
  • the movable edge intersection line 3c in the closed state is offset from the stent axis, that is, offset from the diameter D of the stent 1, and is separated by a certain distance. distance.
  • the mouth portion 34 and the guiding portion 35 are transitionally engaged by an S-shaped edge, and the S-shape includes a first arc edge and a second arc edge that are coupled to each other and face opposite;
  • the first arc edge and the second arc edge do not require a strictly geometric arc, but are merely an overview of their overall shape characteristics, although in some preferred embodiments, the two are respectively a segment of a circular arc.
  • the two ends of the first arc are respectively the end point X1 and the end point X2, the middle part is the vertex Y1, and the vertex Y1 is toward the center line of the leaflet;
  • the two ends of the second arc are respectively the end point X2 and the end point X3, and the middle part is the vertex Y2; the vertex Y2 faces away from the center line of the leaflet.
  • the guiding section 35 has two ends and is distributed on both sides of the center line of the leaflet, and has a corresponding S shape on the other side, and also includes two arc edges which are connected to each other and face opposite, and have an end point X1 corresponding to the first arc side. ⁇ and endpoint X2 ⁇ , the middle is the vertex Y1 ⁇ ; the second arc edge has the endpoint X2 ⁇ and the endpoint X3 ⁇ , and the middle is the vertex Y2 ⁇ .
  • the first arc side is connected with the guiding section 35, the area surrounded by the first arc side is the fin 33, and the vertex Y1' of the first arc side is the apex of the fin;
  • the two ends of the arc are respectively the end point X1 and the end point X2, so the area surrounded by the first arc side is the area surrounded by the arc segment and the boundary line segment of the first arc side, and the two end points of the boundary line segment are the end point X1 and the end point. X2.
  • the second arc edge is engaged with the mouth segment 34, and the apex Y2 of the second arc edge 34 is the end of the mouth segment.
  • the distance between the apex of the wing and the end of the mouth segment in the direction of the centerline of the leaflet is 0.5-0.7 mm, and the first arc edge and the second arc edge are respectively circular or elliptical partial regions, if circular
  • the radius is 0.2 ⁇ 0.8mm, and if it is elliptical, the semi-major axis is 0.2 ⁇ 0.8mm.
  • the fins have an area of 0.1 to 10 square millimeters, and a preferred embodiment is 4 to 6 square millimeters.
  • the span of the movable edge in the axial direction of the stent is greater than 0.5 times the diameter of the stent at the position of the leaflet.
  • the span of the movable edge of the prior art in the axial direction of the stent is almost 0.
  • the active edge increases the extension distance of the movable edge by a larger axial span, so that the mouth segment can be sufficiently far away from the open blood flow channel in the open state.
  • the returning blood flows in the direction of arrow A.
  • the guiding sections of the two leaflets are relatively steep, and are easily close to each other under the action of refluxing blood, and then combined with the further guidance of the airfoil.
  • the active edge of the two leaflets will be sensitively closed, and the mutual fit of the active edges can be regarded as a line contact to a certain extent, and the maintenance of the sealed state is not stable.
  • the fins are provided, and the surface is partially formed. Contact, the active edge of the two leaflets can be locked in the closed state to ensure the sealing effect.
  • the difference from the above embodiments is that in the flattened state of the leaflet 3, the middle portion of the mouth portion 34 is convex toward the apex of the fixed edge, and the closing effect is better when closed.
  • the apex of the convex portion is the active edge apex M1
  • the line connecting the active edge apex M1 and the fixed edge apex M2 is the leaflet center line L1
  • the perpendicular portion F is opposite to the vertical line H of the leaflet center line L1.
  • the apex is raised.
  • the central convex directions of the respective mouth segments are the same or different.
  • the convex directions are the same, especially when the shape of the two leaflets is the same, in the closed state, the mouth segments of the two leaflets are completely coincident, for example, the two leaflets adopt the structure shown in FIG. 3, or both are used. Structure shown in 10.
  • the two leaflets when the shape of the two leaflets is different, especially when the central convex direction of the mouth segment is different, or the amplitude of the convexity is different, in the closed state, the two leaflets are The mouth segments are only partially intersected.
  • the two leaflets in Fig. 11a adopt the structures shown in Fig. 3 and Fig. 10 respectively.
  • the two leaflets are divided into the mouth segments, and the other portions are substantially coincident, one of which is a mouth.
  • the segment 34a is convex toward the apex of the fixed edge
  • one of the mouth segments 34b is convex toward the apex of the fixed edge, and the two meet only at the ends.
  • the mouth portion 34a is convex toward the apex of the fixed edge
  • the mouth portion 34b is convex toward the apex of the fixed edge, but the amplitude of the protrusion is slightly different. It is significantly smaller than the amplitude in Fig. 11a, so that the two intersect at the ends only after the abutment, and the enclosed area is slightly smaller.
  • the mouth portion 34a is convex toward the apex of the fixed edge, and the mouth portion 34b is also convex toward the apex of the fixed edge, but the amplitude of the protrusion is slightly different, and the two are abutted. After only intersecting at the ends.
  • the mouthpiece segment 34a is raised away from the apex of the fixed edge, and the mouthpiece segment 34b extends generally in a straight line, the two of which meet only at the ends.
  • the venous valve replacement device comprises a stent 1 with a blood flow channel and two leaflets attached to the stent 1, respectively a leaflet 3a and a leaflet 3b, a leaflet 3a and a flap
  • One side of the leaf 3b is a fixed edge connected to the stent 1, and the other side is an active edge that cooperates with each other to open and close the blood flow channel.
  • the two leaflets are identical in shape and symmetrically distributed, and the active edge intersection line 3c of the two is along the edge.
  • the axial direction of the bracket is substantially a straight line segment, and the two ends intersect at the bracket 1.
  • the movable edge intersection line 3c passes through the bracket axis and can be regarded as one of the diameters, under the same viewing angle.
  • the arrow direction in FIG. 12 is perpendicular to the active edge intersection line 3c.
  • the span of the two leaflets in the direction of the arrow is the radial span, and the leaflet 3a and the leaflet 3b have the same radial span.
  • the leaflets are fixed in the open and closed states when viewed from the direction of the intersection of the movable edge 3c.
  • the position of the rim 31 and the fixed edge vertex M2 relative to the bracket is constant, while the active edge 32 intersects the axis L of the bracket in the closed state, and the apex M1 of the active edge is on the axis L.
  • the apex M1 of the movable edge is away from the axis L when the leaflet is opened, and abuts against the inner wall of the stent in the direction of the arrow in FIG. 13b.
  • the movable edge 32 also changes correspondingly, and the movable edges of the two leaflets are relatively open. Allow blood flow through, and vice versa when closed.
  • the venous valve replacement device comprises a stent 1 with a blood flow channel and two leaflets attached to the stent 1 with a leaflet side attached to the stent 1
  • the other side is an active edge that cooperates with each other to open and close the blood flow channel.
  • the shape of the two leaflets is not the same, at least the radial span of the two is different, the larger the radial span is the large leaflet, and the smaller the radial span is the small leaflet, taking the angle of view in the figure as an example, the small leaflet Left and has a fixed edge 31a and a movable edge 32a; the large leaflet is right and has a fixed edge 31b and a movable edge 32b.
  • the active edge intersection line 3c of the two leaflets is offset from the axis L of the stent, and the intersection position passes through another straight line L' parallel to the axis L.
  • the use of asymmetric valve leaflets can not only effectively realize the opening and closing function of the venous valve check valve, and further small leaflets can ensure the sensitivity of opening and closing; the large leaflets can achieve the effect of blood transfusion when closing, and realize the layer-by-layer upward movement of blood. delivery.
  • the projection line 3c of the movable edge of the two leaflets in the closed state is projected along the axial direction of the stent.
  • the shape is a straight line segment, the length of the straight line segment is F, and the diameter of the bracket 1 is D.
  • the diameter of the bracket 1 is slightly different in different parts, the diameter of the bracket at the position where the two ends of the movable edge intersecting line 3c are located may be taken, for example, the movable edge
  • the axial position of the end points of the intersecting line 3c is different, and the midpoint of the axial position of the two can be taken, and the diameter of the bracket is D at the same axial position as the midpoint.
  • the ratio of the area of the left small leaflet to the right large leaflet is 0.15 ⁇ 0.8:1 in the closed state, and in the other preferred embodiment, the left small leaflet The ratio of the area of the leaf to the large leaflet on the right side is 0.15 ⁇ 0.5:1.
  • the relationship between the small leaflets and the large leaflets may be determined according to the radial span of the small leaflets and the large leaflets.
  • the radial span reference may be made to the description of FIG. 12, in combination with FIG. 14d, in one embodiment, the radial span J1 of the small leaflets.
  • the ratio of the radial span J2 to the large leaflets is 0.2 to 0.9:1. In a preferred other embodiment, the ratio of the radial span J1 of the small leaflets to the radial span J2 of the large leaflets is 0.3 to 0.6:1.
  • the axial spans of the two leaflets along the axial direction of the stent may be different to further optimize the opening and closing sensitivity.
  • the venous valve replacement device includes a stent with a blood flow channel and two leaflets attached to the stent, one side of the leaflet being a fixed edge connected to the stent, and the other One side is an active edge that cooperates to open and close the blood flow channel.
  • the fixed edge 31a of the left leaflet and the position of the fixed edge apex M2 relative to the stent are constant.
  • the edge of the active edge M1 is opened when the leaflet is opened.
  • the direction of the arrow in Fig. 15b abuts against the inner wall of the stent.
  • the active edge 32a changes correspondingly as a whole, and the movable edge of the two leaflets is relatively open to allow blood flow.
  • the fixed edge 31b of the right leaflet and the position of the fixed edge apex M3 relative to the stent are constant.
  • the active edge apex M4 of the right leaflet opens toward the inner wall of the stent along the arrow direction in FIG. 15b.
  • Adhering, of course, the active edge 32b also changes accordingly, and the active edge of the two leaflets allows the blood to flow through relative opening.
  • the projection edge apex M2 of the left leaflet and the fixed edge apex M3 of the right leaflet do not coincide with each other on the axis L of the stent, that is, the axial positions of the two are different, and the apex of the fixed edge is the downstream direction of the leaflet
  • the most upstream, and the fixed edge of the two leaflets are the same at the most downstream position in the direction of the downstream blood, so that the axial spans of the two leaflets are different.
  • the axial span of the left leaflet is K1
  • the axial span of the right leaflet is K2
  • K1 is significantly smaller than K2.
  • the ratio of K1 to K2 is 0.4 ⁇ 0.95:1. In other preferred embodiments, the ratio of K1 to K2 is from 0.6 to 0.8:1.
  • the difference between K1 and K2 is K
  • the diameter of the stent is D
  • the ratio of K to D is 1/4 to 1/3.
  • the diameter of the brackets on different parts are slightly different, then the diameter of the bracket at the midpoint of the fixed edge vertex M2 and the fixed edge vertex M3 may be taken.
  • the difference in the axial span can also be combined with the difference in the radial span, and can also achieve a better synergistic effect. See also FIGS. 15a and 15b.
  • the two leaflets are The radial span is different, the radial span is larger for the large leaflets, and the radial span is smaller for the small leaflets.
  • the small leaflets are left and have a fixed edge 31a and a movable edge 32a; Right and has a fixed edge 31b and a movable edge 32b.
  • the intersecting lines of the active edges of the two leaflets are offset from the axis L of the stent, and the intersecting position passes through another straight line L' parallel to the axis L.
  • the fixed edge apex M3 of the large leaflet is upstream
  • the fixed edge apex M2 of the small leaflet is downstream. That is, the radial and axial spans of the small leaflets are smaller than the large leaflets.
  • the illustration of the radial span of the two leaflets in this embodiment can be combined with Figure 14d, for example, the ratio of the radial span J1 of the small leaflets to the radial span J2 of the large leaflets is 0.2 to 0.9:1. In a preferred other embodiment, the ratio of the radial span J1 of the small leaflets to the radial span J2 of the large leaflets is 0.3 to 0.6:1.
  • the bracket 1 is cut by a cylinder having a grid structure as a whole, and at least one end of the axial ends is provided with a connecting member 14 for connection with the conveying device.
  • the bracket 1 in the present embodiment is provided with a threading hole 13 for connecting the fixing edge of the leaflet.
  • the threading hole 13 is arranged to facilitate the threading of the suture when the leaflet is sewn, so that the stitching is uniform, and the threading hole 13 can be densely arranged according to the sewing requirement, and the same threading hole is not limited to the threading order.
  • the inner edge of the threading hole 13 is generally required to be relatively smooth, for example, a round hole may be used, and in other embodiments, it may be an oval hole.
  • the threading hole 13 may be formed by local deformation of the structure of the bracket itself, or may be an additional component, or may utilize a hollow portion of the bracket itself.
  • the bracket 1 is provided with two V-shaped fixing strips, and the threading holes 13 are distributed at corresponding positions of the fixing strips.
  • the V-shaped fixing strip includes two fixing rods, which are respectively a fixing rod 11 and a fixing rod 12, and the two fixing rods are arranged obliquely with respect to each other.
  • the two fixing rods may meet at the apex of the V shape.
  • the two fixing rods may each extend up to the apex of the V shape, that is, the fixing rod 11 and the fixing rod 12 are not directly Intersect, but in terms of overall shape, it can also be regarded as a V shape.
  • the apex of the V-shape points to the downstream of the blood downstream direction, and the two sides of the fixed edge of the same leaflet are sewn on different fixed strips instead of the two fixed rods of the same fixed strip.
  • the threading holes on the same fixing rod are spaced apart, for example, 3 to 10, for example, 6 threading holes are fixed on the fixing rod 12 in Fig. 16a, and the threading hole at the intersection with the fixing rod 11 is also regarded as one of them.
  • the number of threading holes is seven. In other embodiments, for example, the threading holes on the fixing rod 12 of FIG. 16d are four.
  • the bracket 1 can adopt a grid structure, and the threading holes can be divided into multiple groups, and the same group of threading holes are arranged on the same fixing rod.
  • the same group of threading holes 13 extend two to six cells with respect to the grid structure of the bracket 1.
  • the threading holes 13 are arranged according to the predetermined stitch spacing and the extending direction of the fixing edge, which can greatly reduce the operation difficulty of sewing the fixing edge, improve the processing efficiency, and reduce the defective rate.
  • the threading holes in the fixed rod 12 extend in three cells, namely cell Y1, cell Y2, cell Y3 in the figure.
  • the threading holes in the fixed rod 12 extend in two cells, cell Y1, cell Y2 in the figure.
  • two V-shaped fixing strips may be disposed on the bracket, one of which is fixed.
  • the fixing rod 11a and the fixing rod 12a which are oblique to the vertex E1 are included;
  • the other fixing bar includes a fixing rod 11b and a fixing rod 12b which are oblique to the vertex E2.
  • the two V-shaped fixing strips may be arranged at intervals or continuously in the circumferential direction.
  • the valve leaf has two pieces, and the fixed edge of each leaflet is sewn on the bracket 1, and two flaps 33 are symmetrically distributed on the movable edge.
  • the movable edge and the flap overlap each other, and of course, the foregoing implementations can also be combined.
  • the active edge and the flaps partially overlap.
  • the fixed edge of the leaflet 3a can be divided into opposite sides with respect to the apex of the fixed edge, one side is sewn to the fixing rod 11a, and the other side is sewn to the fixing rod 11b;
  • the fixed edge of the leaflet 3b can be divided into opposite sides with respect to the apex of the fixed edge, one side is sewn to the fixing rod 12a, and the other side is sewn to the fixing rod 12b. That is, the two fixing rods in the same fixing strip respectively correspond to different one leaflets.
  • the active edges of both the leaflet 3a and the leaflet 3b abut each other on the active edge intersection line 3c.
  • the active edge intersection line 3c passes through the stent axis.
  • the movable edge intersection line 3c deviates from the stent axis.
  • the bracket 1 is formed by interlacing a plurality of support strips.
  • the bracket 1 of the present embodiment is formed by cutting a tube, and the plurality of support strips are interlaced to form a grid structure.
  • Some of the support strips are partially widened, and a fixing rod is formed at the widened portion, such as the fixing rod 11, and the fixing rod 12 itself is a part of the supporting strip, but the width of the portion where the threading hole is not provided is increased, so as to facilitate Threading holes are provided.
  • the fixing rod As a whole fixed strip, it may be of equal width extension, that is, the width is the same in several cell regions in which the threading holes are opened, or may be widened only at the portion where the threading holes are provided, and the width is changed.
  • the fixing rod preferably has an equal width extension in view of ease of processing.
  • the fixing strip is used as a part of the support strip, and the width (that is, the portion where the threading hole is provided) is 2 to 5 mm.
  • the dashed box in the figure indicates the outer contour of the stent at the current viewing angle, and other similar drawings are similar.
  • the two leaflets are symmetrically distributed, the two V-shaped fixed strips are symmetrically distributed on both sides of the stent axis, and the connection between E1 and E2 is the diameter of the stent, and the length of the connection between E1 and E2 is equal to the diameter length D.
  • the fixed rod 11a and the fixed rod 12a intersecting at E1 are also symmetrically distributed on both sides of E1, and the two V-shaped fixed strip spacing distributions are further illustrated in Fig. 18c after the stent is deployed.
  • the distribution of the fixing strip and the fixing rod is also adjusted accordingly, for example, the V-shaped vertex connection of the two V-shaped fixing strips is used as a reference line.
  • the reference line is offset from the axis of the stent.
  • the reference line that is, the line connecting E1 and E2 can also be understood as the intersection line of the active edges of the two leaflets in the closed state.
  • the length E of the line connecting E1 and E2 is the same as the length F of the intersecting line of the active edge, due to the deviation from the axis of the bracket, The length is less than the diameter length D.
  • the viewing angle of Fig. 19a i.e., the viewing angle along the intersection of the active edges
  • the reference line i.e., the position of E1
  • the reference line is offset from the axis L by a distance between the line L' and the axis L.
  • the length ratio of the reference line to the diameter of the bracket reflects the degree of the offset to some extent, and in one embodiment, the length E of the reference line and the diameter length D satisfy: 0.6D ⁇ E ⁇ 1D;
  • the diameter of the bracket varies at different axial positions, reference may be made to the above description of the relationship between the length of the intersecting line of the active edge and the length of the diameter.
  • the axial position corresponding to the diameter is the same as the axial position of the V-shaped apex.
  • the two leaflets are asymmetrical, especially when the lengths of the fixed edges are different, the two fixing rods in the same fixing strip are not equal in length, for example, the fixing rod 11a is shorter than the fixing rod 12a, and the above-mentioned large leaflets and small leaflets are combined.
  • the two sides of the fixed edge of the small leaflet can be respectively sewn to the fixing rod 11a and the fixing rod 11b, and the two sides of the fixing edge of the large leaflet can be respectively sewn to the fixing rod 12a and the fixing rod 12b.
  • each of the fixing rods extends substantially in a straight line, and two fixing rods in the same fixing strip, for example, the fixing rod 11a and the fixing rod 12a are different from the axial direction of the bracket, and the shorter fixing rod 11a and the axis L are different.
  • the angle is smaller, and the longer fixing rod 12a has a larger angle with the axis L.
  • the angle between the fixing rod 11a and the fixing rod 12a is greater than 0 degrees and less than or equal to 60 degrees, for example, between 45 and 60 degrees.
  • the axial spans of the fixed rod 11a and the fixed rod 12a are substantially the same.
  • the axial spans of the two leaflets are different.
  • the axial widths of the two fixing rods in the same fixing strip, such as the fixing rod 11a and the fixing rod 12a are different.
  • the viewing angle in the drawing can be understood as the bottom end of the fixing rod 11a being higher than the bottom end of the fixing rod 12a.
  • the shape of the fixing strips on the brackets is also matched as much as possible, the difficulty of sewing is reduced, the processing efficiency is improved, and the sealing effect is further ensured.

Abstract

一种静脉瓣置换装置，包括带有血流通道的支架（1）以及连接在支架（1）上的两片瓣叶（3），各瓣叶（3）一侧为与支架（1）相连的固定缘（31），另一侧为相互配合用以开闭所述血流通道的活动缘（32），两片瓣叶（3）的活动缘（32）处设有闭合状态下相互贴靠的翼片（33）。该静脉瓣置换装置通过在活动缘（32）增加翼片（33）提高密封性，更进一步地通过活动缘形状扩大了开口面积以保证血流顺畅，还避免了局部血栓的形成，提高了安全性。

Description

一种静脉瓣置换装置 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种静脉瓣置换装置，可通过介入方式置入体内以改善静脉返流。
 背景技术
为了缓解和治疗静脉返流，现有技术中公开了多种人造静脉瓣膜的结构和使用方法，有些产品结构复杂，可靠性不佳，还有一些产品中采用相对简单的网管状支架并结合瓣叶的方式，瓣叶的形式常见的有单叶瓣、两叶瓣或三叶瓣。
静脉血流速较慢，瓣叶的开启关闭需要格外灵敏，三叶瓣在这方面难以满足，而单叶瓣和二叶瓣主要问题是难以兼顾通道开放面积和密封性。
另外在瓣叶关闭时，瓣叶与支架之间容易在正常血流的上游侧形成局部血栓，也是急待解决的问题。
 技术问题
本申请提供一种静脉瓣置换装置，在两叶瓣可灵敏开闭的基础上对存在的问题进行了结构改进，获得了良好的密封性。
 技术解决方案
一种静脉瓣置换装置，包括带有血流通道的支架以及连接在支架上的两片瓣叶，各瓣叶一侧为与支架相连的固定缘，另一侧为相互配合用以开闭所述血流通道的活动缘，两片瓣叶的活动缘处设有闭合状态下相互贴靠的翼片。
以下还提供了若干可选方式，但并不作为对上述总体方案的额外限定，仅仅是进一步的增补或优选，在没有技术或逻辑矛盾的前提下，各可选方式可单独针对上述总体方案进行组合，还可以是多个可选方式之间进行组合。
本申请采用的支架本身可利用现有技术，具有筒状结构以适应静脉内腔的形状，其筒状结构并不要求是完整的圆筒，至少提供一支撑在静脉内腔的支撑环以及与固定缘形状相应的支撑结构。为了便于压缩和释放，支架采用可径向压缩的网状结构，例如通过编织或切割加工而成。网状结构可采用规则分布或不规则的单元结构。
瓣叶本身的材料可利用现有技术，比如采用猪心包膜或牛心包膜等生物膜，瓣叶通过缝缀等方式固定在支架上，本申请的改进之处重点在于采用两叶瓣以及瓣叶的形状，两片瓣叶的活动缘形成单向阀结构，在正常静脉血流（以下简称顺流血）的作用下开放，但血压间隙变化时，为了防止静脉返流，两片瓣叶的活动缘相互贴合密封关闭，在关闭过程中，翼片起到的引导作用。
由于翼片凸起在所处的活动缘，在返流血的作用下，相互配合的两翼片会具有更加明显的相互靠拢趋势，从而牵引所在的瓣叶朝向另一瓣叶靠拢，实现两片瓣叶活动缘的贴合关闭。
不仅如此，在瓣叶关闭后，相互配合的两翼片相互搭置贴靠，具有较大的接触面积，相对于活动缘其他部位仅靠边缘区域贴合，两翼片具有更好的锁合效果，进一步保证了密封效果。
可选的，所述翼片与所在的瓣叶为一体结构。
采用一体材料更加便于加工，在与活动缘结合的部位也可以获得更好的强度，为了避免局部应力集中，在翼片与活动与结合部位的边缘采用光滑线过渡。
可选的，所述翼片凸设于所处的活动缘。
活动缘整体而言为连续延伸的曲线，在翼片部位具有局部延伸趋势的突变，由于需要借助翼片引导瓣叶关闭以及锁合，因此从总体趋势上看，翼片外凸于所处的活动缘部位。
可选的，所述翼片的面积为0.1至10平方毫米，进一步优选4平方毫米至6平方毫米。
可选的，所述固定缘的形状为抛物线，顶点处在血液顺流方向的上游，并由顶点起在两侧向下游逐渐延伸。
翼片应具有一定的面积以起到相应的引导作用，但面积过大反而会给活动缘的开启带来额外的阻力，会降低单向阀开启的灵敏性。
可选的，两片瓣叶上的翼片位置相匹配且形状相同。
如果仅仅是引导关闭，两瓣叶上相互配合的翼片在位置上并不要求一致，容许错位布置，但若需发挥锁定闭合作用，则两者至少有局部相互贴靠，甚至可以是局部形变相互包裹。
可选的，所述活动缘的中部朝固定缘一侧凸起或背向固定缘一侧凸起，凸起部位的顶点为活动缘顶点。由于固定缘与之间内缘固定贴合，结合两叶瓣的特征，一般情况下固定缘大致为抛物线状，活动缘的中部朝向或背向固定缘凸起应理解大致的趋势，例如活动缘的中部区域为弧形，而弧顶的朝向可视为凸起朝向，采用弧形方式可以适当增加两活动缘的长度，在开启时提高通道截面积。
可选的，同一瓣叶上的翼片有两片；两翼片分别位于活动缘顶点的两侧。
每一瓣叶的活动缘上，翼片至少有一片，为了提高相应效果可适当增加翼片的数量，在优选方案中每一瓣叶的活动缘上设置两片翼片，为了提高闭合后的密封效果，翼片的位置应避让活动缘的中部区域，中部指在活动缘延伸方向的中部，例如活动缘为一曲线，则中部理解为曲线中点附近。
可选的，两翼片对称的分布在活动缘顶点的两侧。
同一瓣叶上，两翼片的对称分布使得两侧张合运动一致性更好，如果一侧先关闭有可能导致另一侧在血流作用下形变严重而影响闭合效果。
可选的，所述两片瓣叶为一体结构。
采用一体结构可一次性裁剪出两片瓣叶，而后合围成筒状并缝缀在支架上。
可选的，闭合状态下，所述活动缘处在二维平面内。
可选的，闭合状态下，所述活动缘沿支架轴向的投影形状为直线段。
可选的，闭合状态下两片瓣叶的活动缘相交线通过支架轴线或偏离支架轴线。
可选的，瓣叶展平状态下，所述固定缘的中部背向活动缘凸起，固定缘中部凸起部位的顶点为固定缘顶点，活动缘中部凸起部位的顶点为活动缘顶点。
固定缘和活动缘整体上均类似于抛物线，各自中部的顶点大致为各自的中点，就顶点附近的局部而言，活动缘顶点凸起的方向可按前述朝向或背向固定缘。
可选的，所述活动缘顶点与固定缘顶点的连线为瓣叶中心线。
就每片瓣叶而言，优选采用对称结构，瓣叶中心线即为瓣叶形状的对称轴。
针对同一瓣叶的固定缘，在支架上设置两组穿线孔，分别位于固定缘顶点的两侧。例如每组穿线孔为3至10个。
可选的，所述活动缘与固定缘处在瓣叶中心线同侧的部位逐渐靠拢并通过缝缀片连接，该缝缀片与支架相固定。
缝缀片用于加强瓣叶的尖端部位，即固定缘和活动缘的交汇部位，缝缀片也更便于操作缝缀在支架上，缝缀片的形状没有严格限制，一般可与所处位置的单元格形状相应，恰好可以覆盖相应的单元格并缝缀在单元格周边的支撑条上。
可选的，闭合状态下所述瓣叶中心线与支架轴线的夹角为30~60度。优选30~45度。
瓣叶中心线与支架轴线的夹角大致上反映了两瓣叶闭合状态下的夹角，夹角影响瓣叶开闭的灵敏度。
瓣叶中心线与支架轴线的夹角过大，例如接近90度时，可视为两瓣叶几乎共面，会使活动缘的开启需要更强的血流冲击，且不容易形成较大的开口面积，很明显流速较慢的静脉血难以满足这一要求。
而夹角过小，会使瓣叶的固定缘和活动缘沿轴向延伸较长距离才会交汇，开闭容许有较大的形变，但反而会引起形变量过大密封性不好的负面影响。
可选的，活动缘在邻近缝缀片的部位设有提高相对自由度的切口。
活动缘在延伸至末端（远离活动缘顶端的一端）时与缝缀片衔接，由于缝缀片是固定在支架上，因此会影响活动缘即束缚活动缘的自由度，通过切口降低活动缘运动时与缝缀片的关联度，能够改善和提高活动缘开闭的灵活性。
可选的，所述切口的边缘为光滑的曲线。
边缘为光滑的曲线，在受到拉伸时可避免局部应力集中，降低撕裂的风险。
可选的，所述活动缘包括位于活动缘顶点附近的成口段，以及位于成口段两侧的引导段；所述成口段的径向外扩速率为V1，引导段的径向外扩速率为V2，且V1大于V2；
所述径向外扩速率为沿支架轴向延伸单位距离时，径向位置的变化量。
成口段相对平直（延伸趋势更接近支架径向），可以提高开闭速度和灵敏性，引导段较长且较立陡（延伸趋势更接近支架轴向）一方面可以配合成口段获得较大的开口面积，更重要的闭合状态下可以更加贴近支架内壁，避免局部血液积存而形成血栓。
可选的，V1为V2的4至20倍。
可选的，闭合状态下，所述成口段在支架径向上的跨度占支架在瓣叶位置处直径的至少2/3。
成口段在径向上具有足够的长度可以保证较大的开口面积。
可选的，所述翼片位于成口段与引导段的衔接处。
翼片也可视为活动缘延伸趋势的突变部位，一侧为成口段，开闭时会导致血流通道面积突变，提高反应速度，另一侧为引导段促进瓣叶的相应部分闭合状态下尽可能的贴靠支架。
可选的，瓣叶展开状态下，沿活动缘中心线方向，翼片与活动缘顶点的距离为活动缘跨度的1/10至1/2。
翼片的合适位置保证活动缘的密封效果，整体而言，翼片在活动缘中心线方向上到活动缘顶点的距离比到活动缘末端的距离近，可有效发挥闭合锁定的效果。
可选的，闭合状态下，所述活动缘处在二维平面内。
现有技术中，为了提高活动缘开口的面积，一些技术中加大了活动缘长度，导致闭合后大于活动缘的径向跨度，因此闭合后呈现往复弯折的状态，即活动缘在三维空间内延伸，而本申请中通过立陡的引导段可以保证开口面积，避免在成口段形成三维往复折弯结构。
可选的，闭合状态下，所述活动缘沿支架轴向的投影形状为直线段。
可选的，闭合状态下两片瓣叶的活动缘相交线通过支架轴线或偏离支架轴线。
两片瓣叶对称分布时，闭合状态下两片瓣叶的活动缘相交线通过支架轴线，若两片瓣叶形状或大小不同，即非对称分布时，闭合状态下两片瓣叶的活动缘相交线偏离即不通过支架轴线。
可选的，瓣叶展开状态下，所述成口段沿直线延伸，或所述成口段的中部背向固定缘顶点凸起，或朝向固定缘顶点凸起；两片瓣叶中，各自成口段的中部凸起方向相同或不同。
可选的，闭合状态下，两片瓣叶中的成口段完全重合或仅局部相交。
可选的，所述成口段与引导段之间通过边缘为S形的区域过渡衔接，S形包括相互衔接且朝向相反的第一弧边和第二弧边；
所述第一弧边与引导段衔接，第一弧边所围的区域为所述翼片，第一弧边的顶点为翼片顶点；
所述第二弧边与成口段衔接，第二弧边的顶点为成口段末端。
可选的，瓣叶展开状态下，翼片顶点与成口段末端之间在瓣叶中心线方向上的距离为0.5~0.7mm。
适宜的形状可以充分发挥翼片的功效，第二弧边的顶点朝向大致为沿支架径向向外，可以进一步加大成口段的径向跨度，而S形的迂回使得引导段相应的瓣叶部位适当增加宽度，提高引导以及防血栓效果。
可选的，所述第一弧边以及第二弧边分别为圆形或椭圆的局部区域，所述圆形的半径为0.2~0.8mm，所述椭圆的半长轴为0.2~0.8mm。
弧边的形状，尤其是第一弧边与翼片的外轮廓形状相应，本申请针对其形状以及尺寸范围也作了优选，翼片与成口段末端部位的形状相互协同，可以兼顾成口段的开口面积以及翼片的闭合引导作用。
可选的，所述翼片顶点指向瓣叶中心线。
可选的，开启状态下，两片瓣叶中活动缘的成口段完全分离。
可选的，闭合状态下，所述活动缘由活动缘顶点起两侧分别朝血流下游延伸，且在延伸的同时沿支架径向各自远离活动缘顶点。
可选的，所述引导段在支架轴向上的长度为支架直径的1/3至3倍。
引导段有足够的长度，才可以有足够的径向形变向支架内侧贴靠以避免血栓，支架的直径可根据所处静脉血管的直径相应调整，因此引导段的轴向长度与支架的直径具有相应的比例关系。
可选的，所述瓣叶包括与成口段位置相应的中部以及与引导段位置相应的侧部，闭合状态下，所述侧部朝临近的支架内侧壁贴近。
侧部朝临近的支架内侧壁贴近，可以在瓣叶关闭的时候，最大限度的将侧部与支架内侧的血液排挤出来，避免残留形成血栓。
可选的，闭合状态下，所述活动缘在支架轴向上的跨度大于支架在瓣叶位置处直径的0.5倍，更优选0.6至3倍。
可选的，开启状态下血流通道的截面积为支架在瓣叶位置处截面积的至少70%。
可选的，所述支架的内壁还设有覆膜。
覆膜可以构建血流通道，提高瓣叶的控流效果，覆膜本身可采用现有技术中的材料，与瓣叶可以是相同或不同的材料。
可选的，所述覆膜为筒状，且处在瓣叶的上游侧，覆膜朝向瓣叶的一端与各瓣叶的固定缘衔接，以构建血流通道。
可选的，所述覆膜远离瓣叶的一端的边缘间隔的设有多个裁切区。
通过裁切部分区域更有利支架的径向压缩。作为进一步的优选，所述裁切区为三角形或梯形、半圆形等。
可选的，所述两片瓣叶的径向跨度不同，径向跨度较大为大瓣叶，径向跨度较小为小瓣叶，闭合状态下两片瓣叶的活动缘相交线偏离支架轴线；
闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述径向跨度所跨的方向与所述直线段垂直。
可选的，闭合状态下，所述小瓣叶与所述大瓣叶沿支架轴向的投影面积之比为0.15~0.8:1。
可选的，闭合状态下，所述小瓣叶与所述大瓣叶的径向跨度之比为0.2~0.9:1。
可选的，闭合状态下，所述小瓣叶与所述大瓣叶的径向跨度之比为0.3~0.6:1。
可选的，闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述直线段与所述支架的直径之间满足：0.6D≤F<1D；
式中F为所述直线段的长度，D为所述支架的直径且该直径所对应的轴向位置与所述直线段端点的轴向位置相同。
可选的，所述直线段与所述支架的直径之间满足：0.7D≤F≤0.95D。
可选的，所述两片瓣叶沿支架轴向的轴向跨度不同。
可选的，瓣叶展平状态下，所述固定缘的中部背向活动缘凸起，固定缘中部凸起部位的顶点为固定缘顶点；两片瓣叶的固定缘顶点在支架轴线上的投影位置不重合。
可选的，所述小瓣叶与所述大瓣叶的轴向跨度之比为0.4~0.95:1。
可选的，所述小瓣叶与所述大瓣叶的轴向跨度之比为0.6~0.8:1。
可选的，所述两片瓣叶的径向跨度不同，径向跨度较大为大瓣叶，径向跨度较小为小瓣叶，闭合状态下两片瓣叶的活动缘相交线偏离支架轴线；闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述径向跨度所跨的方向与所述直线段垂直；
沿使用状态下的血液顺流方向，大瓣叶的固定缘顶点处在上游，小瓣叶的固定缘顶点处在下游。
可选的，两片瓣叶的固定缘顶点在支架轴线上的投影位置距离为K，所述支架的直径为D，且K与D之比为1/4~1/3。
现有技术中的支架通过交错分布的支撑条构成，固定瓣叶时通过缝线将固定缘缝在位置相应的支撑条上，控制针脚位置以及均匀性有较高的专业要求，另外各瓣叶在支架上的相对位置也需要在缝缀过程中时常纠偏，提高了操作难度。
支架本身在相邻支撑条之间会有一定间隙，但该间隙的排布与支撑条的排布以及网格形状有关，一般也会比较大，尽管可在间隙中穿引缝线，但缝线的位置并不固定。
可选的，所述支架上排布有用于连接瓣叶固定缘的穿线孔。
本申请中，穿线孔的孔径比较小，缝线穿过后很少会有滑移，穿线孔的设置可以利用支撑条的宽度并在宽度范围内加工穿线孔，更主要的是穿线孔的排布与固定缘的走向相应，沿穿线孔的排布延伸方向逐点缝缀固定缘可大大降低操作难度，提高加工效率，降低次品率。
可选的，所述支架上设有两个V形的固定条，所述穿线孔分布在所述固定条的相应位置上；
所述V形的顶点在使用状态下指向血流下游，同一瓣叶中固定缘的两侧缝在不同的固定条上。
可选的，所述V形的固定条包括两根固定杆；
所述支架在展开状态下，两根固定杆相对倾斜布置，同一固定条中的两根固定杆分别对应不同的一片瓣叶。
可选的，所述两根固定杆交汇于V形的顶点或各自延伸直至邻近V形的顶点。
可选的，所述支架在展开状态下，各固定杆与所述支架的轴线倾斜布置。
可选的，所述支架为多根支撑条交错形成，其中一些支撑条的局部加宽，且在加宽部位形成所述固定杆，所述穿线孔分为若干组，同组穿线孔排布在其中一根固定杆上。
单根支撑条的延伸方向与固定缘的延伸方向很难完全一致，因此针对同一瓣叶的固定缘，其对应的穿线孔可分为依次衔接的若干组，同组按照与固定缘的对应关系分布在不同的支撑条上，延伸方向没有突变或明显转折的可视为同一支撑条。
可选的，所述支撑条至少在设置穿线孔的部位加宽。
可选的，所述固定杆等宽延伸。
可选的，所述支撑条的加宽部位的宽度为2至5mm。
由于穿线孔需要一定的孔径以通过针线，因此在布置穿线孔的支撑条的相应部分可以按需设置宽度，穿线孔本身可根据常用的针、线设置孔径。
可选的，穿线孔为圆孔或椭圆孔。
穿线孔具有光滑的内缘便于穿线，同一支撑条的穿线孔可均匀间隔分布，也可依照固定缘的延伸方向相应调整。
可选的，所述支架为网格结构，同组穿线孔延伸2至6个单元格。
可选的，所述两个V形的固定条在支架周向上间隔布置。
可选的，所述两个V形的固定条对称分布在支架轴线的两侧。
可选的，所述两个V形的固定条的V形顶点连线作为参照线；在沿支架轴向的视角中，所述参考线偏离支架的轴线。
可选的，所述参照线与所述支架的直径之间满足：0.6D≤E<1D；
式中E为所述参照线的长度，D为所述支架的直径且该直径所对应的轴向位置与所述V形顶点的轴向位置相同。
可选的，所述参照线与所述支架的直径之间满足：0.7D≤E≤0.95D。
可选的，同一固定条中的两根固定杆不等长。
可选的，所述支架在展开状态下，同一固定条中的两根固定杆与支架轴线方向的夹角不同。
可选的，同一固定条中的两根固定杆大致沿直线延伸，且两根固定杆之间的夹角大于0度且小于等于60度。
 有益效果
本申请静脉瓣置换装置通过在活动缘增加翼片提高密封性，更进一步的通过活动缘形状的扩大了开口面积以保证血流顺畅，还避免了局部血栓的形成，提高了安全性。
 附图说明
图1为本申请静脉瓣置换装置闭合状态下的结构示意图，图中省略支架并用虚线框表示相对位置；
图2为图1中静脉瓣置换装置开启状态下的结构示意图；
图3为本申请静脉瓣置换装置中瓣叶的展开状态示意图；
图4为图3中瓣叶连同支架覆膜的示意图；
图5为其中一对比例中静脉瓣置换装置闭合状态的结构示意图；
图6为图5中静脉瓣置换装置开启状态的结构示意图；
图7为另一对比例中静脉瓣置换装置闭合状态的结构示意图；
图8为图3中瓣叶的局部示意图；
图9a，图9b为不同实施方式中闭合状态的活动缘相交线示意图；
图10为其中一实施方式中瓣叶的展开状态示意图；
图11a~图11d不同实施方式中两瓣叶展平叠置的状态示意图；
图12为轴向视角下，其中一实施方式中两瓣叶的结构示意图；
图13a，图13b为在瓣叶对称的实施方式中，沿活动缘相交线方向视角的两瓣叶闭合、开启状态结构示意图；
图14a~图14d为在瓣叶非对称的实施方式中，两瓣叶不同视角和状态下的结构示意图；
图15a，图15b为在瓣叶非对称的另一实施方式中，沿活动缘相交线方向视角的两瓣叶闭合、开启状态结构示意图；图16a~图16d为不同的实施方式中，支架部分在不同视角下的结构示意图；
图17a~图17d为不同的实施方式中，静脉瓣置换装置在不同视角下的结构示意图；
图18a~图18c为在瓣叶对称的实施方式中，静脉瓣置换装置上固定条的分布示意图；
图19a~图19c为在瓣叶非对称的实施方式中，静脉瓣置换装置上固定条的分布示意图；
图20a~图20c为在另一瓣叶非对称的实施方式中，静脉瓣置换装置上固定条的分布示意图。
 本发明的实施方式
下面将结合本申请实施方式中的附图，对本申请实施方式中的技术方案进行清楚、完整地描述，显然，所描述的实施方式仅仅是本申请一部分实施方式，而不是全部的实施方式。基于本申请中的实施方式，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施方式，都属于本申请保护的范围。
为了更好地描述和说明本申请的实施方式，可参考一幅或多幅附图，但用于描述附图的附加细节或示例不应当被认为是对本申请的发明创造、目前所描述的实施方式或优选方式中任何一者的范围的限制。
需要说明的是，当组件被称为与另一个组件“连接”时，它可以直接与另一个组件连接或者也可以存在居中的组件。当一个组件被认为是“设置于”另一个组件，它可以是直接设置在另一个组件上或者可能同时存在居中组件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本申请。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
参见图1~图4，本申请其中一实施方式中，提供一种静脉瓣置换装置，包括带有血流通道的支架1以及连接在支架1上的两片瓣叶3，各瓣叶3一侧为与支架1相连的固定缘31，另一侧为相互配合用以开闭血流通道的活动缘32，两片瓣叶3的活动缘32处设有闭合状态下相互贴靠的翼片33。
本申请中各个实施方中的翼片，即使在瓣叶展平时，仍明显凸设于活动缘的边缘，而并非在褶皱或其他特定视角下才予以体现。
支架1整体上为网筒结构，通过编织或切割加工而成且可径向压缩，以便于装载入输送装置，以介入方式输送至静脉血管指定位置后释放，支架1起到支撑静脉血管内壁的作用，支架1内部作为血流通道。
支架1上设有两片瓣叶3，各瓣叶一侧边为与支架1相连的固定缘31，固定缘31大致呈抛物线状，固定缘31通过缝缀的方式固定在支架内侧。
其他实施方式中，支架1也可以采用简化形式，即仅包括一支撑静脉血管内壁的环形部分，以及与该环形部分相连且与两瓣叶固定缘形状相应的支撑框。环形部分在轴向上也可略延伸，延伸距离与覆膜2的轴向尺寸相当。支撑框支架或间接（通过连接杆）与环形部分相连。
各瓣叶另一侧为相互配合用以开闭血流通道的活动缘32，正常情况下，静脉血沿箭头B方向流动，两瓣叶的活动缘在血流作用下分离，即开放血流通道，静脉血返流时，两瓣叶在返流血沿箭头A方向的作用下闭合，两活动缘相互贴合，防止静脉血的进一步返流。
根据密封需求，另一实施方式中，支架1内侧还设有覆膜2，覆膜2的顶缘与瓣叶3的固定缘31衔接，底缘间隔的设有多个三角形的裁切区，覆膜2围成筒状，在结合部位通过接缝21缝合连接在一起。
翼片33与所在的瓣叶3可以是分体或一体结构。两瓣叶之间既可以为分体结构也可以是一体结构。
优选的实施方式中，翼片33凸设于所处的活动缘32。两瓣叶上的翼片相互重叠可加大接触面积、保证密封效果。
就瓣叶3本身而言，本申请对其形状也做了相应改进，其中一实施方式中，瓣叶3展平状态下，固定缘31的中部背向活动缘凸起，固定缘中部凸起部位的顶点为固定缘顶点M2，活动缘中部朝固定缘侧凸起，凸起部位的顶点为活动缘顶点M1。
使用状态下，固定缘的总体形状为抛物线，固定缘顶点处在血液顺流方向的上游，并由固定缘顶点起在两侧向下游逐渐延伸。为了保证阻止血液逆流，固定缘与支架之间处处封闭。
就单片瓣叶3而言，在优选的实施方式中采用大致对称结构，例如活动缘顶点M1与固定缘顶点M2的连线为瓣叶中心线L1；瓣叶3相对于瓣叶中心线L1大体上为对称结构。
其中一实施方式中，闭合状态下，瓣叶中心线L1与支架轴线L2之间夹角为30~60度，在优选的实施方式中瓣叶中心线L1与支架轴线L2之间夹角为30~45度。闭合状态下，瓣叶中心线L1与支架轴线L2之间夹角大致上反映了两瓣叶闭合状态下的夹角，夹角影响瓣叶开闭的灵敏度。
闭合状态下，活动缘32由活动缘顶点起两侧分别朝血流下游延伸，且在延伸的同时沿支架径向各自远离活动缘顶点，为了进一步保证瓣叶开口有足够的面积，在其中一实施方式中，活动缘32在支架轴向上的跨度大于支架在瓣叶位置处直径的0.5倍。
每片瓣叶上的翼片可设置多个，例如2~4个，一般可分为两组分别在瓣叶中心线L1两侧。
其中一个实施方式中，每片瓣叶上的翼片33有两个，在瓣叶中心线L1两侧各设置一个。
在优选的实施方式中两个翼片33关于瓣叶中心线L1对称分布。
两片瓣叶上相配合的翼片并不严格限制大小或相同，至少保证部分区域可以在闭合状态下相互重叠贴靠，在优选的实施方式中两片瓣叶上的翼片结构相同且闭合时位置相对应。翼片结构相同可视为形状尺寸大致匹配，在理想的叠置状态下，两者边缘对齐，当然考虑加工以及缝缀的误差，本实施方式中并不要求严格一致，例如某一翼片80%的区域与另一匹配的翼片相贴合。
沿活动缘中心线方向，翼片33的位置对开启的灵敏度以及封闭效果也存在一定影响，在其中一实施方式中，瓣叶展开状态下，沿活动缘中心线方向，翼片33与活动缘顶点的距离为活动缘跨度的1/10至1/2。即在活动缘的整体跨度上，翼片33更加接近活动缘顶点。
为了便于保持瓣叶与支架之间的相对位置关系，由于是活动缘与固定缘趋近相交的部位，瓣叶尺寸较窄，为便于缝缀，其中一实施方式中，活动缘32与固定缘31处在瓣叶中心线L1同侧的部位逐渐靠拢并通过缝缀片36连接，该缝缀片36与支架1相固定。
活动缘32可由翼片33起沿光滑曲线直至延伸到支架1内侧附近，但为了提高瓣叶在活动缘32一侧的灵活开闭，在其中一实施方式中，活动缘32在邻近缝缀片36的部位设有提高相对自由度的切口37。在优选的实施方式中，为避免局部应力集中，切口37的边缘为光滑的曲线，通过切口37可以减少活动缘32受缝缀片36的束缚，能够改善和提高活动缘32开闭的灵活性。
为了进一步划分以及便于表述活动缘32的结构特点，其中一实施方式中，活动缘32包括位于活动缘顶点M1附近的成口段34，以及位于成口段34两侧的引导段35。
图3中可见相对于瓣叶中心线L1的垂线H，成口段34比较平直，可以提高开闭速度和灵敏性，两侧的引导段35较立陡可以配合成口段34获得较大的开口面积，闭合状态下可以更加贴近支架内壁，避免引导段顶部与支架之间的区域C积存血液而形成血栓。
为了进一步对比成口段34与引导段35的延伸趋势，设成口段34的径向外扩速率为V1，引导段35的径向外扩速率为V2，且V1大于V2，例如在不同的实施方式中，V1为V2的4至20倍。
径向外扩速率为沿支架轴向延伸单位距离时，径向位置的变化量，径向外扩速率越大，即径向延伸的分量越大，整体趋势也更将平直。
引导段35有足够的长度，才可以有足够的径向形变向支架内侧贴靠以避免血栓，其中一实施方式中，引导段35在支架轴向上的长度为支架直径的1/3至3倍。
成口段43在径向上具有足够的长度可以保证较大的开口面积，闭合状态下，其中一实施方式中，成口段34在支架径向上的跨度占支架在瓣叶位置处直径的至少2/3。
在优选的实施方式中，开启状态下，两片瓣叶的成口段34完全分离，血流通道的截面积为支架在瓣叶位置处截面积的80%以上，至少为70%。
血流通道的周边是活动缘围成的，为了提供足够的截面积，两片瓣叶的活动缘在自身延伸方向上应具有足够的长度，在两者中长度达到支架周向长度时，在理论上血流通道的截面积设置可达支架在瓣叶位置处截面积的100%，
例如在其中一实施方中，活动缘在自身延伸方向上的长度为支架直径的1.4倍至支架周长的一半。
受缝缀方式原因限制，以支架等径延伸为例，血流通道的截面积一般会比支架截面积略小。
在其中一实施方中，支架在瓣叶的缝缀部分处直径加大，这样可以尽量避让缝缀增厚区域，保证血流通道足够的截面积。参见图5和图6，现有技术中在其他领域的一些二叶瓣结构中，为了保证密封性，活动缘32整体上比较平直有利于绷紧关闭，但关闭后在血流的上游侧瓣叶3与支架1之间的区域C空间较大，容易积存血液而形成血栓。另外由于活动缘比较绷直，因此开启后难以形成截面积较大的血流通道。参见图7，为了保证开口面积，尽管可以通过加长活动缘32的方式，但关闭后会形成弯折，造成两片瓣叶局部分离，影响密封性。
本实施方式的静脉瓣置换装置中，闭合状态下，活动缘32处在二维平面内。
参见图9a，其中一优选的实施方式是闭合状态下，活动缘沿支架轴向的投影形状为直线段，避免了三维空间上弯折。图中支架1内部分别设置瓣叶3a和瓣叶3b，闭合状态下两瓣叶的活动缘相互贴合封闭血流通道，沿支架轴向的视角上相互贴合的部位为活动缘相交线3c，图中可见活动缘相交线3c为直线段。
沿支架轴向的视角上瓣叶3a和瓣叶3b形状相同时，闭合状态下的活动缘相交线3c通过支架轴线，也可以视为活动缘相交线3c为支架1的直径。
参见图9b，在其他实施例中，若瓣叶3a和瓣叶3b形状并非对称，则闭合状态下的活动缘相交线3c偏离支架轴线，即与支架1的直径D相互偏移，隔开一定距离。
参见图8，瓣叶3展开状态下，成口段34与引导段35之间通过边缘为S形的区域过渡衔接，S形包括相互衔接且朝向相反的第一弧边和第二弧边；
第一弧边和第二弧边并不要求严格几何意义上的弧形，仅仅是对其整体形状特点的概述，当然在某些优选的实施方式中，两者分别为圆弧的一段。
第一弧边的两端分别为端点X1和端点X2，中部为顶点Y1，顶点Y1朝向瓣叶中心线；
第二弧边的两端分别为端点X2和端点X3，中部为顶点Y2；顶点Y2背向瓣叶中心线。
引导段35为两端且分布在瓣叶中心线两侧，在另一侧，具有相应的S形，也包括相互衔接且朝向相反的两弧边，与第一弧边相对应的具有端点X1`和端点X2`，中部为顶点Y1`；与第二弧边相对应的具有端点X2`和端点X3`，中部为顶点Y2`。
以左侧为例，右侧同理，第一弧边与引导段35衔接，第一弧边所围的区域为翼片33，第一弧边的顶点Y1`为翼片顶点；由于第一弧边的两端分别为端点X1和端点X2，因此第一弧边所围的区域为第一弧边的弧形段与边界线段所围的区域，边界线段的两个端点即端点X1和端点X2。
第二弧边与成口段34衔接，第二弧边34的顶点Y2为成口段末端。
翼片顶点与成口段末端之间在瓣叶中心线方向上的距离为0.5~0.7mm，第一弧边以及第二弧边分别为圆形或椭圆的局部区域，若为圆形则的半径为0.2~0.8mm，若为椭圆则半长轴为0.2~0.8mm。
其中一实施方式中，翼片的面积为0.1至10平方毫米，优选的实施方式为4至6平方毫米。
本实施方式中闭合状态下，活动缘在支架轴向上的跨度大于支架在瓣叶位置处直径的0.5倍，图5，图7中现有技术的活动缘在支架轴向上的跨度几乎为0，本实施方式活动缘通过较大的轴向跨度提高了活动缘的延伸距离，可使得成口段在开启状态下充分远离开放血流通道。
本实施方式中的静脉瓣置换装置工作时，正常的静脉血沿箭头B方向流动，对两瓣叶施加压力，两瓣的活动缘相互分离，成口段完全分离。
静脉血回流时，返流血沿箭头A方向流动，返流血经过引导段直至翼片时，两瓣叶的引导段比较立陡，容易在返流血作用下相互贴近，再结合翼片的进一步引导，两瓣叶的活动缘会灵敏的关闭，活动缘的相互贴合在一定程度上可视为线接触，密封状态的保持并不是稳定，但本实施方式中由于设置了翼片，在局部形成面接触，可以将两瓣叶的活动缘锁定在闭合状态，保证密封效果。
参见图10，在另一实施方式中，与上述各实施方式的不同之处在于瓣叶3展平状态下，成口段34的中部背向固定缘顶点凸起，关闭时封闭效果更好。
凸起部位的顶点为活动缘顶点M1，活动缘顶点M1与固定缘顶点M2的连线为瓣叶中心线L1，相对于瓣叶中心线L1的垂线H，成口段34背向固定缘顶点凸起。尽管本实施例中成口段34背向固定缘顶点凸起，但就活动缘整体而言，仍可视为中部朝向固定缘顶点凸起。
两片瓣叶中，各自成口段的中部凸起方向相同或不同。当凸起方向相同，尤其是两片瓣叶形状相同时，闭合状态下，两片瓣叶中的成口段完全重合，例如两片瓣叶均采用图3所示的结构，或均采用图10所示的结构。
参见图11a和图11d，在一些实施方式中，当两片瓣叶形状不同，尤其是成口段的中部凸起方向不同，或凸起的幅度不同时，闭合状态下，两片瓣叶中的成口段仅局部相交。图11a中的两瓣叶分别采用图3、图10所示的结构，为便于比较图中以展平状态表示，两片瓣叶除成口段以外，其他部位基本重合，其中一者成口段34a背向固定缘顶点凸起，其中一者成口段34b朝向固定缘顶点凸起，两者贴靠后仅在端部相交。
相对于图11a，在图11b所示的另一实施方中，尽管成口段34a背向固定缘顶点凸起，成口段34b朝向固定缘顶点凸起，但凸起的幅度略有不同，明显小于图11a中的幅度，因此两者贴靠后仅在端部相交，且围成的区域面积略小。
在图11c所示的另一实施方中，成口段34a背向固定缘顶点凸起，成口段34b也背向固定缘顶点凸起，但凸起的幅度略有不同，两者贴靠后仅在端部相交。
在图11d所示的另一实施方中，成口段34a背向固定缘顶点凸起，成口段34b大致沿直线延伸，两者贴靠后仅在端部相交。
参见图12，其中一实施例中，静脉瓣置换装置包括带有血流通道的支架1以及连接在支架1上的两片瓣叶，分别为瓣叶3a和瓣叶3b，瓣叶3a和瓣叶3b一侧为与支架1相连的固定缘，另一侧为相互配合用以开闭血流通道的活动缘，两片瓣叶形状相同且对称分布，两者的活动缘相交线3c在沿支架轴向的视角上大致为直线段，两端相交于支架1，由于两片瓣叶形状相同且对称分布，活动缘相交线3c通过支架轴线，可视为其中一直径，在同样的视角下，图12中箭头方向垂直活动缘相交线3c，沿箭头方向两片瓣叶的跨度为径向跨度，瓣叶3a和瓣叶3b径向跨度相同。
为进一步清楚说明，结合图12，图13a，图13b，以图12中其中一瓣叶为例，在沿活动缘相交线3c方向的视角下，瓣叶在开启与闭合两状态切换时，固定缘31以及固定缘顶点M2相对于支架的位置是不变的，而活动缘32在闭合状态时相交于支架的轴线L，活动缘顶点M1处在轴线L上。
在顺流血的作用下，瓣叶开启时活动缘顶点M1远离轴线L，沿图13b中箭头方向朝支架内壁贴靠，当然活动缘32整体上也相应变化，两瓣叶的活动缘相对张开容许血流通过，同理闭合时反之。
参见图14a~图14d，在其中一实施方式中，静脉瓣置换装置包括带有血流通道的支架1以及连接在支架1上的两片瓣叶，瓣叶一侧为与支架1相连的固定缘，另一侧为相互配合用以开闭血流通道的活动缘。
两片瓣叶形状并不相同，至少两者的径向跨度不同，径向跨度较大的为大瓣叶，径向跨度较小的为小瓣叶，以图中视角为例，小瓣叶居左且具有固定缘31a和活动缘32a；大瓣叶居右且具有固定缘31b和活动缘32b。
闭合状态下两片瓣叶的活动缘相交线3c偏离支架的轴线L，相交位置过与轴线L平行的另一直线L’。采用不对称瓣叶不仅可以有效实现静脉瓣单向阀开闭功能，更进一步的小瓣叶能保证开闭灵敏性；大瓣叶可实现关闭时兜血的效果，实现兜血的逐层向上输送。
小瓣叶与大瓣叶两者一定的比例关系，可进一步优化相应的效果，参见图14c，其中一实施方式中，闭合状态下两片瓣叶的活动缘相交线3c沿支架轴向的投影形状为直线段，直线段的长度为F，支架1的直径为D，若不同部位上支架1的直径略有不同，那么可取活动缘相交线3c两端点所在位置的支架直径，又例如活动缘相交线3c两端点轴向位置不同，可取两者轴向位置的中点，与该中点在相同轴向位置处在支架直径为D。本实施例中满足：0.6D≤F<1D；在优选的其他实施方式中0.7D≤F≤0.95D。
结合图14d，沿支架轴向视角，闭合状态下，左侧的小瓣叶与右侧的大瓣叶的面积之比为0.15~0.8:1，在优选的其他实施方式中左侧的小瓣叶与右侧的大瓣叶的面积之比为0.15~0.5:1。
另外，也可以依照小瓣叶与大瓣叶的径向跨度来确定两者关系，有关径向跨度可以参照图12的描述，结合图14d，在其中一实施方式中小瓣叶的径向跨度J1与大瓣叶的径向跨度J2之比为0.2~0.9:1。在优选的其他实施方式中小瓣叶的径向跨度J1与大瓣叶的径向跨度J2之比为0.3~0.6:1。
在两片瓣叶采用非对称方式时，无论两者径向跨度是否相同，在一些实施方式中还可以是两片瓣叶沿支架轴向的轴向跨度不同，以进一步优化开闭灵敏性。
参见图15a和图15b，在其中一实施方式中，静脉瓣置换装置包括带有血流通道的支架以及连接在支架上的两片瓣叶，瓣叶一侧为与支架相连的固定缘，另一侧为相互配合用以开闭血流通道的活动缘。
瓣叶在开启与闭合两状态切换时，左侧瓣叶的固定缘31a以及固定缘顶点M2相对于支架的位置是不变的，在顺流血的作用下，瓣叶开启时活动缘顶点M1沿图15b中箭头方向朝支架内壁贴靠，当然活动缘32a整体上也相应变化，两瓣叶的活动缘相对张开容许血流通过。同理，右侧瓣叶的固定缘31b以及固定缘顶点M3相对于支架的位置是不变的，在顺流血的作用下，瓣叶开启时活动缘顶点M4沿图15b中箭头方向朝支架内壁贴靠，当然活动缘32b整体上也相应变化，两瓣叶的活动缘相对张开容许血流通过。
左侧瓣叶的固定缘顶点M2与右侧瓣叶的固定缘顶点M3在支架的轴线L上的投影位置不重合，即两者轴向部位不同，固定缘顶点为所在瓣叶的顺流血方向的最上游，而两瓣叶固定缘在顺流血方向的最下游位置相同，这样两片瓣叶轴向跨度不同。
图15a可见，左侧瓣叶轴向跨度为K1，右侧瓣叶的轴向跨度为K2，K1明显小于K2，在其中一实施方式中，K1与K2之比为0.4~0.95:1，在其他优选的实施方式中，K1与K2之比为0.6~0.8:1。
为了进一步优化两瓣叶的轴向跨度，在其中一实施方式中，K1与K2之差为K，支架的直径为D，且K与D之比为1/4~1/3。
若不同部位上支架的直径略有不同，那么可取固定缘顶点M2与固定缘顶点M3轴向中点位置处的支架直径。
在一些实施方式中，轴向跨度的不同还可以与径向跨度的不同相结合，亦可起到较好的协同效果，还可以参见图15a和图15b，本实施例中两片瓣叶的径向跨度不同，径向跨度较大为大瓣叶，径向跨度较小为小瓣叶，以图中视角为例，小瓣叶居左且具有固定缘31a和活动缘32a；大瓣叶居右且具有固定缘31b和活动缘32b。
闭合状态下两片瓣叶的活动缘相交线偏离支架的轴线L，相交位置过与轴线L平行的另一直线L’。沿血液顺流方向，大瓣叶的固定缘顶点M3处在上游，小瓣叶的固定缘顶点M2处在下游。即小瓣叶径向、轴向跨度均小于大瓣叶。本实施例中关于两瓣叶的径向跨度的示意可结合图14d，例如小瓣叶的径向跨度J1与大瓣叶的径向跨度J2之比为0.2~0.9:1。在优选的其他实施方式中小瓣叶的径向跨度J1与大瓣叶的径向跨度J2之比为0.3~0.6:1。
参见图16a~图17d，本实施方式中支架1采用切割方式，整体上为网格结构的圆筒，在轴向的两端的至少一端设有连接件14用于与输送装置相连。
为了便于瓣叶的安装，本实施方式中的支架1上排布有用于连接瓣叶固定缘的穿线孔13。
穿线孔13的设置便于在缝缀瓣叶时穿引缝线，使得针脚均匀，穿线孔13疏密可依据缝缀要求设置，同一穿线孔内并不限于穿引依次。
穿线孔13内缘一般要求相对比较光滑，例如可以采用圆孔，其他实施方式中也可以是椭圆孔。穿线孔13可以是利用支架自身结构的局部形变加工而成，也可以是额外的部件，亦或利用支架自身的镂空部位。
其中一实施方式中，支架1上设有两个V形的固定条，穿线孔13分布在固定条的相应位置上。
例如图16a~图16d中，V形的固定条包括两根固定杆，分别为固定杆11和固定杆12，两根固定杆相对倾斜布置。
两根固定杆可以交汇于V形的顶点，在其他实施方式中，如图16d所示还可以是两根固定杆各自延伸直至邻近V形的顶点，即固定杆11和固定杆12并不直接相交，但就整体造型而言，也可视为V形。
实际使用状态下，V形的顶点指向血液顺流方向的下游，同一瓣叶中固定缘的两侧缝在不同的固定条上，而非同一固定条的两固定杆上。
同一固定杆上的穿线孔为间隔分布的多个，例如3至10个，例如图16a中固定杆12上的穿线孔为6个，若与固定杆11交汇部位的穿线孔也视为其中之一，则穿线孔为7个，在其他实施方式中，例如图16d的固定杆12上的穿线孔为4个.
支架1可采用网格结构，而穿线孔可分为多组，同组穿线孔布置在同一固定杆上，相对于支架1的网格结构，同组穿线孔13延伸两至六个单元格。穿线孔13按照预定的针脚间隔以及固定缘的延伸方向布置，可大大降低缝缀固定缘的操作难度，提高加工效率，降低次品率。
例如图16a所示的实施方式中，固定杆12上的穿线孔延伸三个单元格，即图中的单元格Y1，单元格Y2，单元格Y3。
例如图16d所示的实施方式中，固定杆12上的穿线孔延伸两个单元格，即图中的单元格Y1，单元格Y2。
由于固定缘大致为抛物线，且两瓣叶的固定缘端部基本是相交的，参见图17a~图17d，其中一实施方式中，支架上可设置两个V形的固定条，其中一固定条包括斜交于顶点E1的固定杆11a和固定杆12a；
另一固定条包括斜交于顶点E2的固定杆11b和固定杆12b。两个V形的固定条在周向上可以间隔布置或连续分布。
瓣叶有两片，各瓣叶的固定缘缝缀于支架1上，活动缘上对称分布两个翼片33，两瓣叶闭合时活动缘以及翼片相互重合，当然还可以结合前述各实施例，两瓣叶闭合时活动缘以及翼片部分重合。
瓣叶3a的固定缘相对于固定缘顶点可分为相对的两侧，一侧缝缀于固定杆11a，另一侧缝缀于固定杆11b；
同理，瓣叶3b的固定缘相对于固定缘顶点可分为相对的两侧，一侧缝缀于固定杆12a，另一侧缝缀于固定杆12b。即同一固定条中的两根固定杆分别对应不同的一片瓣叶。
闭合状态下，瓣叶3a和瓣叶3b两者的活动缘相互贴靠在活动缘相交线3c。两瓣叶对称分布时活动缘相交线3c过支架轴线，采用非对称分布时，尤其是径向跨度不同时活动缘相交线3c偏离支架轴线。
其中一实施方式中，支架1为多根支撑条交错形成，本实施方式的支架1采用管材切割的方式加工成型，多根支撑条交错围成网格结构。
其中一些支撑条的局部加宽，且在加宽部位形成固定杆，例如固定杆11，固定杆12本身即是支撑条的一部分，但比照没有设置穿线孔的部位宽度上有所增加，以便于开设穿线孔。
作为某一固定条整体而言，可以是等宽延伸，即在开设穿线孔的几个单元格区域内宽度相同，还可以是仅仅在设置穿线孔的部位加宽，相当于宽度是变化的。考虑到加工方便，固定杆优选等宽延伸。
固定条作为支撑条的一部分，宽度（即设置穿线孔的部位）为2至5mm。
参见图18a~图18c，图中虚线框表示支架在当前视角下的外轮廓，其他类似附图同理。两瓣叶对称分布时，两个V形的固定条对称分布在支架轴线的两侧，且E1与E2的连线即为支架直径，E1与E2的连线长度等于直径长度D。
相交于E1的固定杆11a和固定杆12a也对称分布在E1两侧，支架展开后在图18c进一步示意了两个V形的固定条间隔分布。
参见图19a~图19c，在两瓣叶非对称结构的一些实施例中，固定条以及固定杆的分布也相应调整，例如两个V形的固定条的V形顶点连线作为参照线，在沿支架轴向的视角中如图19b，参考线偏离支架的轴线。
参照线即E1与E2的连线，还可以理解为闭合状态下两瓣叶的活动缘相交线，E1与E2的连线长度E与活动缘相交线长度F相同，由于偏离支架轴线，因此在长度上均小于直径长度D。
关于参照线偏离支架轴线还可结合图19a的视角，即沿活动缘相交线的视角，参照线即E1所在位置偏离轴线L，偏移的距离为直线L’与轴线L的间距。
参照线与支架的直径的长度比在一定程度上反映了偏移的程度，在其中一实施方式中参照线的长度E与的直径长度D之间满足：0.6D≤E<1D；
支架的直径在不同的轴向位置有变化时，可参照前述有关活动缘相交线长度与直径长度关系的叙述。例如该直径所对应的轴向位置与V形顶点的轴向位置相同。
在优选的实施方式中，0.7D≤E≤0.95D。
当然，若两瓣叶不对称，尤其是固定缘长度不同时，同一固定条中的两根固定杆不等长，例如固定杆11a比固定杆12a短，结合前述有关大瓣叶和小瓣叶的叙述，小瓣叶固定缘的两侧可分别缝缀于固定杆11a和固定杆11b，大瓣叶固定缘的两侧可分别缝缀于固定杆12a和固定杆12b。
支架在展开状态下，各固定杆大致沿直线延伸，同一固定条中的两根固定杆，例如固定杆11a和固定杆12a与支架轴线方向的夹角不同，较短的固定杆11a与轴线L的夹角更小，而较长的固定杆12a与轴线L的夹角更大。
就同一固定条中的两根固定杆而言，例如固定杆11a和固定杆12a之间的夹角大于0度且小于等于60度，例如在45~60度之间。
若两瓣叶固定缘顶点的轴向位置相同，则固定杆11a和固定杆12a的轴向跨度大致相同。
在一些实施方式中，两瓣叶轴向跨度不同，相应的参见图20a~图20c，同一固定条中的两根固定杆，例如固定杆11a和固定杆12a的轴向宽度也不相同，从图中的视角可理解为固定杆11a的底端高于固定杆12a的底端。
总之依照瓣叶的不同的特点，支架上固定条的形状也尽可能的相匹配，降低缝缀难度，提高加工效率，也进一步保证了密封效果。
以上所述实施方式的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施方式中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
不同实施方式中的技术特征体现在同一附图中时，可视为该附图也同时披露了所涉及的各个实施方式的组合例。
以上公开的仅为本申请的具体实施方式，但是本申请并非局限于此，本领域的技术人员可以对本申请进行各种改动和变型而不脱离本申请的精神和范围。显然这些改动和变型均应属于本申请要求的保护范围保护内。此外，尽管本说明书中使用了一些特定的术语，但这些术语只是为了方便说明，并不对本申请构成任何特殊限制。

Claims (70)

  1. 一种静脉瓣置换装置，包括带有血流通道的支架以及连接在支架上的两片瓣叶，各瓣叶一侧为与支架相连的固定缘，另一侧为相互配合用以开闭所述血流通道的活动缘，其特征在于，两片瓣叶的活动缘处设有闭合状态下相互贴靠的翼片。
  2. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述翼片与所在的瓣叶为一体结构。
  3. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述翼片凸设于所处的活动缘。
  4. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述翼片的面积为4至6平方毫米。
  5. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述固定缘的形状为抛物线，顶点处在血液顺流方向的上游，并由顶点起在两侧向下游逐渐延伸。
  6. 如权利要求1所述的静脉瓣置换装置，其特征在于，闭合状态下，相互贴靠的两翼片中，任一者80%以上面积区域与另一者相贴合。
  7. 如权利要求6所述的静脉瓣置换装置，其特征在于，两片瓣叶上的翼片位置相匹配且形状相同。
  8. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述活动缘的中部朝固定缘一侧凸起或背向固定缘一侧凸起，凸起部位的顶点为活动缘顶点。
  9. 如权利要求8所述的静脉瓣置换装置，其特征在于，同一瓣叶上的翼片有两片；两翼片分别位于活动缘顶点的两侧。
  10. 如权利要求9所述的静脉瓣置换装置，其特征在于，两翼片对称的分布在活动缘顶点的两侧。
  11. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述两片瓣叶为一体结构。
  12. 如权利要求1所述的静脉瓣置换装置，其特征在于，闭合状态下，所述活动缘处在二维平面内。
  13. 如权利要求12所述的静脉瓣置换装置，其特征在于，闭合状态下，所述活动缘沿支架轴向的投影形状为直线段。
  14. 如权利要求1所述的静脉瓣置换装置，其特征在于，闭合状态下两片瓣叶的活动缘相交线通过支架轴线或偏离支架轴线。
  15. 如权利要求1所述的静脉瓣置换装置，其特征在于，瓣叶展平状态下，所述固定缘的中部背向活动缘凸起，固定缘中部凸起部位的顶点为固定缘顶点，活动缘中部凸起部位的顶点为活动缘顶点。
  16. 如权利要求15所述的静脉瓣置换装置，其特征在于，所述活动缘顶点与固定缘顶点的连线为瓣叶中心线。
  17. 如权利要求16所述的静脉瓣置换装置，其特征在于，所述活动缘与固定缘处在瓣叶中心线同侧的部位逐渐靠拢并通过缝缀片连接，该缝缀片与支架相固定。
  18. 如权利要求17所述的静脉瓣置换装置，其特征在于，闭合状态下所述瓣叶中心线与支架轴线的夹角为30~60度。
  19. 如权利要求16所述的静脉瓣置换装置，其特征在于，活动缘在邻近缝缀片的部位设有提高相对自由度的切口。
  20. 如权利要求19所述的静脉瓣置换装置，其特征在于，所述切口的边缘为光滑的曲线。
  21. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述活动缘包括位于活动缘顶点附近的成口段，以及位于成口段两侧的引导段；所述成口段的径向外扩速率为V1，引导段的径向外扩速率为V2，且V1大于V2；
    所述径向外扩速率为沿支架轴向延伸单位距离时，径向位置的变化量。
  22. 如权利要求21所述的静脉瓣置换装置，其特征在于，V1为V2的4至20倍。
  23. 如权利要求21所述的静脉瓣置换装置，其特征在于，闭合状态下，所述成口段在支架径向上的跨度占支架在瓣叶位置处直径的至少2/3。
  24. 如权利要求21所述的静脉瓣置换装置，其特征在于，所述翼片位于成口段与引导段的衔接处。
  25. 如权利要求24所述的静脉瓣置换装置，其特征在于，瓣叶展开状态下，沿活动缘中心线方向，翼片与活动缘顶点的距离为活动缘跨度的1/10至1/2。
  26. 如权利要求21所述的静脉瓣置换装置，其特征在于，瓣叶展开状态下，所述成口段沿直线延伸，或所述成口段的中部背向固定缘顶点凸起，或朝向固定缘顶点凸起；两片瓣叶中，各自成口段的中部凸起方向相同或不同。
  27. 如权利要求21所述的静脉瓣置换装置，其特征在于，闭合状态下，两片瓣叶中的成口段完全重合或仅局部相交。
  28. 如权利要求21所述的静脉瓣置换装置，其特征在于，所述成口段与引导段之间通过边缘为S形的区域过渡衔接，S形包括相互衔接且朝向相反的第一弧边和第二弧边；
    所述第一弧边与引导段衔接，第一弧边所围的区域为所述翼片，第一弧边的顶点为翼片顶点；
    所述第二弧边与成口段衔接，第二弧边的顶点为成口段末端。
  29. 如权利要求28所述的静脉瓣置换装置，其特征在于，瓣叶展开状态下，翼片顶点与成口段末端之间在瓣叶中心线方向上的距离为0.5~0.7mm。
  30. 如权利要求28所述的静脉瓣置换装置，其特征在于，所述第一弧边以及第二弧边分别为圆形或椭圆的局部区域，所述圆形的半径为0.2~0.8mm，所述椭圆的半长轴为0.2~0.8mm。
  31. 如权利要求28所述的静脉瓣置换装置，其特征在于，所述翼片顶点指向瓣叶中心线。
  32. 如权利要求28所述的静脉瓣置换装置，其特征在于，所述引导段在支架轴向上的长度为支架直径的1/3至3倍。
  33. 如权利要求28所述的静脉瓣置换装置，其特征在于，开启状态下，两片瓣叶中活动缘的成口段完全分离。
  34. 如权利要求28所述的静脉瓣置换装置，其特征在于，所述瓣叶包括与成口段位置相应的中部以及与引导段位置相应的侧部，闭合状态下，所述侧部朝临近的支架内侧壁贴近。
  35. 如权利要求1所述的静脉瓣置换装置，其特征在于，闭合状态下，所述活动缘在支架轴向上的跨度大于支架在瓣叶位置处直径的0.5倍。
  36. 如权利要求1所述的静脉瓣置换装置，其特征在于，开启状态下血流通道的截面积为支架在瓣叶位置处截面积的至少70%。
  37. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述支架的内壁还设有覆膜。
  38. 如权利要求37所述的静脉瓣置换装置，其特征在于，所述覆膜为筒状，且处在瓣叶的上游侧，覆膜朝向瓣叶的一端与各瓣叶的固定缘衔接，以构建血流通道。
  39. 如权利要求38所述的静脉瓣置换装置，其特征在于，所述覆膜远离瓣叶的一端的边缘间隔的设有多个裁切区。
  40. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述两片瓣叶的径向跨度不同，径向跨度较大为大瓣叶，径向跨度较小为小瓣叶，闭合状态下两片瓣叶的活动缘相交线偏离支架轴线；
    闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述径向跨度所跨的方向与所述直线段垂直。
  41. 如权利要求40所述的静脉瓣置换装置，其特征在于，闭合状态下，所述小瓣叶与所述大瓣叶沿支架轴向的投影面积之比为0.15~0.8:1。
  42. 如权利要求40所述的静脉瓣置换装置，其特征在于，闭合状态下，所述小瓣叶与所述大瓣叶的径向跨度之比为0.2~0.9:1。
  43. 如权利要求42所述的静脉瓣置换装置，其特征在于，闭合状态下，所述小瓣叶与所述大瓣叶的径向跨度之比为0.3~0.6:1。
  44. 如权利要求40所述的静脉瓣置换装置，其特征在于，闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述直线段与所述支架的直径之间满足：0.6D≤F<1D；
    式中F为所述直线段的长度，D为所述支架的直径且该直径所对应的轴向位置与所述直线段端点的轴向位置相同。
  45. 如权利要求44所述的静脉瓣置换装置，其特征在于，所述直线段与所述支架的直径之间满足：0.7D≤F≤0.95D。
  46. 如权利要求1所述的静脉瓣置换装置，其特征在于，所述两片瓣叶沿支架轴向的轴向跨度不同。
  47. 如权利要求46所述的静脉瓣置换装置，其特征在于，瓣叶展平状态下，所述固定缘的中部背向活动缘凸起，固定缘中部凸起部位的顶点为固定缘顶点；两片瓣叶的固定缘顶点在支架轴线上的投影位置不重合。
  48. 如权利要求46所述的静脉瓣置换装置，其特征在于，所述小瓣叶与所述大瓣叶的轴向跨度之比为0.4~0.95:1。
  49. 如权利要求48所述的静脉瓣置换装置，其特征在于，所述小瓣叶与所述大瓣叶的轴向跨度之比为0.6~0.8:1。
  50. 如权利要求46所述的静脉瓣置换装置，其特征在于，所述两片瓣叶的径向跨度不同，径向跨度较大为大瓣叶，径向跨度较小为小瓣叶，闭合状态下两片瓣叶的活动缘相交线偏离支架轴线；闭合状态下两片瓣叶的活动缘相交线沿支架轴向的投影形状为直线段，所述径向跨度所跨的方向与所述直线段垂直；
    沿使用状态下的血液顺流方向，大瓣叶的固定缘顶点处在上游，小瓣叶的固定缘顶点处在下游。
  51. 如权利要求50所述的静脉瓣置换装置，其特征在于，两片瓣叶的固定缘顶点在支架轴线上的投影位置距离为K，所述支架的直径为D，且K与D之比为1/4~1/3。
  52. 如权利要求1~51任一项所述的静脉瓣置换装置，其特征在于，所述支架上排布有用于连接瓣叶固定缘的穿线孔。
  53. 如权利要求52所述的静脉瓣置换装置，其特征在于，所述支架上设有两个V形的固定条，所述穿线孔分布在所述固定条的相应位置上；
    所述V形的顶点在使用状态下指向血液顺流方向的下游，同一瓣叶中固定缘的两侧缝在不同的固定条上。
  54. 如权利要求53所述的静脉瓣置换装置，其特征在于，所述V形的固定条包括两根固定杆；
    所述支架在展开状态下，两根固定杆相对倾斜布置，同一固定条中的两根固定杆分别对应不同的一片瓣叶。
  55. 如权利要求54所述的静脉瓣置换装置，其特征在于，所述两根固定杆交汇于V形的顶点或各自延伸直至邻近V形的顶点。
  56. 如权利要求54所述的静脉瓣置换装置，其特征在于，所述支架在展开状态下，各固定杆与所述支架的轴线倾斜布置。
  57. 如权利要求56所述的静脉瓣置换装置，其特征在于，所述支架为多根支撑条交错形成，其中一些支撑条的局部加宽，且在加宽部位形成所述固定杆，所述穿线孔分为若干组，同组穿线孔排布在其中一根固定杆上。
  58. 如权利要求57所述的静脉瓣置换装置，其特征在于，所述支撑条至少在设置穿线孔的部位加宽。
  59. 如权利要求58所述的静脉瓣置换装置，其特征在于，所述固定杆等宽延伸。
  60. 如权利要求57所述的静脉瓣置换装置，其特征在于，所述支撑条的加宽部位的宽度为2至5mm。
  61. 如权利要求52所述的静脉瓣置换装置，其特征在于，穿线孔为圆孔或椭圆孔。
  62. 如权利要求52所述的静脉瓣置换装置，其特征在于，所述支架为网格结构，同组穿线孔延伸2至6个单元格。
  63. 如权利要求53所述的静脉瓣置换装置，其特征在于，所述两个V形的固定条在支架周向上间隔布置。
  64. 如权利要求53所述的静脉瓣置换装置，其特征在于，所述两个V形的固定条对称分布在支架轴线的两侧。
  65. 如权利要求53所述的静脉瓣置换装置，其特征在于，所述两个V形的固定条的V形顶点连线作为参照线；在沿支架轴向的视角中，所述参考线偏离支架的轴线。
  66. 如权利要求65所述的静脉瓣置换装置，其特征在于，所述参照线与所述支架的直径之间满足：0.6D≤E<1D；
    式中E为所述参照线的长度，D为所述支架的直径且该直径所对应的轴向位置与所述V形顶点的轴向位置相同。
  67. 如权利要求66所述的静脉瓣置换装置，其特征在于，所述参照线与所述支架的直径之间满足：0.7D≤E≤0.95D。
  68. 如权利要求54所述的静脉瓣置换装置，其特征在于，同一固定条中的两根固定杆不等长。
  69. 如权利要求54所述的静脉瓣置换装置，其特征在于，所述支架在展开状态下，同一固定条中的两根固定杆与支架轴线方向的夹角不同。
  70. 如权利要求69所述的静脉瓣置换装置，其特征在于，同一固定条中的两根固定杆大致沿直线延伸，且两根固定杆之间的夹角大于0度且小于等于60度。
PCT/CN2019/081973 2018-04-09 2019-04-09 一种静脉瓣置换装置 WO2019196845A1 (zh)

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