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WO2022048585A1 - 介入静脉瓣支架及静脉瓣假体 - Google Patents

介入静脉瓣支架及静脉瓣假体 Download PDF

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Publication number
WO2022048585A1
WO2022048585A1 PCT/CN2021/116157 CN2021116157W WO2022048585A1 WO 2022048585 A1 WO2022048585 A1 WO 2022048585A1 CN 2021116157 W CN2021116157 W CN 2021116157W WO 2022048585 A1 WO2022048585 A1 WO 2022048585A1
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WO
WIPO (PCT)
Prior art keywords
wave
frame
interventional
venous valve
support frame
Prior art date
Application number
PCT/CN2021/116157
Other languages
English (en)
French (fr)
Inventor
王永胜
郭伟
李建民
Original Assignee
杭州诺谊医疗科技有限公司
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
Priority claimed from CN202010925749.2A external-priority patent/CN114145884A/zh
Priority claimed from CN202021921538.3U external-priority patent/CN212630964U/zh
Application filed by 杭州诺谊医疗科技有限公司 filed Critical 杭州诺谊医疗科技有限公司
Publication of WO2022048585A1 publication Critical patent/WO2022048585A1/zh

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    • 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

Definitions

  • the present application relates to the technical field of implantable blood vessels, and in particular, to an interventional venous valve stent and a venous valve prosthesis provided with the interventional venous valve stent.
  • Venous surgery disease is a common disease in surgery, which mostly occurs in the lower extremities. Its main clinical manifestations are varicose veins, limb swelling, and skin dystrophic lesions in the boot area, such as dermatitis, pigmentation, and ulceration.
  • the main pathological reason is that the venous valve loses the basic function of one-way opening under the action of pathogenic factors. Mild cases of venous disease hinder the ability to live and work, and severe cases can cause different degrees of disability. Therefore, the treatment of lower extremity venous valve disease has received increasing attention. At present, most of the clinical treatment of the disease is still conservative, such as drug therapy, pressure pump, etc., and surgical treatment such as femoral vein valve repair and reconstruction, etc., the clinical effect is not ideal.
  • venous valve transplantation seems to be the only method of choice.
  • the reasons for the poor anchoring force and insufficient compliance of the prosthesis after implantation in the blood vessel make the clinical effect of the venous valve prosthesis unsatisfactory.
  • How to provide a venous valve prosthesis with good anchoring performance and good flexibility is a technical problem that needs to be solved urgently in the art.
  • the purpose of this application is to provide a venous valve prosthesis and an interventional venous valve stent with better clinical effects.
  • an interventional venous valve stent capable of radial compression and expansion, including a support body and a connecting skeleton, the support body including a first annular support skeleton, and the connecting skeleton is connected to the The end of the first annular supporting frame, the connecting frame is arranged along the circumferential direction of the first annular supporting frame and is disconnected in the circumferential direction of the connecting frame to form a gap, and at least part of the connecting frame is outside The bulge forms a bulge, and the inner side of the bulge forms a sinus area.
  • the present application also provides a venous valve prosthesis for implanting into a venous blood vessel
  • the venous valve prosthesis includes an interventional venous valve stent and a valve assembly
  • the valve assembly includes a valve leaflet connected to the inner side of the connecting frame
  • the The leaflet shield is disposed at least in part of the sinus region and is used to construct a one-way passage in the venous vessel.
  • the gap on the connecting frame of the venous valve prosthesis reduces the excessive expansion of the venous vessel wall by the protrusion of the connecting frame, and the gap enables the interventional venous valve stent to have better flexibility, making the interventional venous valve stent better It is easier to pass through complicated blood vessels and reduce the risk of surgery; in addition, the valve leaflets are in a suspended state under the action of the vortex and do not fit with the vein wall, which can reduce the risk of adhesion, and the formed vortex can also avoid blood at the root of the valve leaflet.
  • valve leaflets move toward the gap under the impact of blood backflow in the venous vessel and abut against the inner wall of the venous vessel around the gap, causing the returning blood to form a vortex in the sinus area covered by the valve leaflet, preventing blood flow Regression, and avoid the risk of thrombosis due to blood flow retention at the root of the valve leaflet; thus, the clinical effect of the venous valve prosthesis is better.
  • FIG. 1 is a schematic diagram of the use state of the venous valve prosthesis provided by the first embodiment of the present application
  • FIG. 2 is a schematic diagram of the anti-reflux state of the venous valve prosthesis provided by the first embodiment of the present application;
  • FIG. 3 is a schematic three-dimensional structural diagram of a venous valve prosthesis provided by the first embodiment of the present application.
  • Figure 4 is a front view of the venous valve prosthesis in Figure 3;
  • FIG. 5 is a schematic diagram of one of the use states of the venous valve prosthesis provided by the first embodiment of the present application.
  • FIG. 6 is a schematic diagram of another use state of the venous valve prosthesis provided by the first embodiment of the present application.
  • Figure 7 is a left side view of the interventional venous valve stent of the venous valve prosthesis in Figure 3;
  • Figure 8 is a front view of the interventional venous valve stent in Figure 3;
  • Fig. 9 is the three-dimensional exploded structure schematic diagram of the valve assembly in Fig. 3;
  • Fig. 10 is a perspective assembly schematic diagram of the valve assembly in Fig. 9;
  • FIG. 11 is a schematic three-dimensional structural diagram of a venous valve prosthesis provided by the second embodiment of the present application.
  • FIG. 12 is a front view of the interventional venous valve stent provided by the third embodiment of the present application.
  • Figure 13 is a left side view of the interventional venous valve stent in Figure 12;
  • FIG. 14 is a schematic three-dimensional structural diagram of an interventional venous valve stent provided by the fourth embodiment of the present application.
  • FIG. 15 is a front view of the interventional venous valve stent of FIG. 14 .
  • proximal end in this application refers to the end close to the heart position
  • distal end refers to the end away from the heart position
  • the present application provides a venous valve prosthesis 100 for implantation in a venous blood vessel 300 for constructing a one-way passage in the venous blood vessel 300 to avoid blood backflow.
  • Fig. 1 shows a schematic diagram of the use state of the venous valve prosthesis 100. At this time, under the impact of downstream blood flow from the proximal end to the distal end, the blood flow path of the venous valve prosthesis 100 is opened, and Fig. 2 shows the venous valve prosthesis.
  • 100 is a schematic diagram of the anti-reflux state, at this time, under the impact of the reverse flow from the distal end to the proximal end, the blood flow path of the venous valve prosthesis 100 is closed.
  • the venous valve prosthesis 100 includes an interventional venous valve stent 20 and a valve assembly 70 .
  • the interventional venous valve stent 20 is a mesh cylinder structure and can be radially compressed and expanded.
  • the interventional venous valve stent 20 includes a support body and a connecting frame 40, the support body includes a first annular support frame 30 and a second annular support frame 50, and the connecting frame 40 is located between the first annular support frame 30 and the second annular support frame 40.
  • the connecting frame 40 is arranged along the circumferential direction of the first annular supporting frame 30 and the second annular supporting frame 50, and is disconnected in the circumferential direction of the connecting frame 40 to form a gap 401, and at least part of the connecting frame 40 protrudes outward to form a protruding portion 41, the inner side of the protruding portion 41 forms a sinus region 403.
  • the protruding portion 41 is formed by the side wall of the connecting frame 40 being outwardly protruded away from the inner cavity of the connecting frame 40 approximately in the radial direction.
  • the so-called "sinus area”, that is, the area where the inner surface of the connecting frame 40 is concave, can also be understood as the area where the local inner diameter increases in the lumen enclosed by the connecting frame 40 .
  • the valve assembly 70 includes a valve body 72 attached to the inner side of the connecting frame 40 and a valve leaflet 74 attached to the inner side of the valve body 72 , the valve leaflet 74 covering at least a portion of the sinus region 403 .
  • the valve body 72 is attached to the inner surface of the connecting frame 40, and the valve leaflet 74 is connected to the side of the valve body 72 away from the connecting frame 40; specifically, the valve body 72 is sutured, bonded or hot-pressed to the connecting frame. 40.
  • valve leaflet 74 One edge of the valve leaflet 74 is sutured, bonded or thermally pressed to the valve body 72, so that the valve leaflet 74 and the part of the valve body 72 covered by the valve leaflet 74 enclose a V-shaped vortex accommodating space in cross-section.
  • the cross section is parallel to the axial direction of the intervening venous valve stent 20.
  • the V-shaped cross section of the V-shaped vortex accommodating space is only a specific example, and does not constitute a The shape of the vortex accommodating space is defined, and the shape of the vortex accommodating space may be a regular geometric figure or an irregular geometric figure that can be conceived by those skilled in the art.
  • the interventional venous valve stent 20 is adhered to the intima of the venous blood vessel 300, so that the interventional venous valve stent 20 is stably anchored to the venous blood vessel 300, preventing the blood in the venous blood vessel 300 from leaking from the venous blood vessel 300.
  • the intervening venous valve stent 20 leaks out from the intima of the venous blood vessel 300 , that is, all the blood flows in the lumen of the intervening venous valve stent 20 . Referring to FIG.
  • the leaflet 74 includes a fixed edge 742 and a free edge 745 , the fixed edge 742 is fixedly connected to the valve body 72 , and the free edge 745 is freely suspended.
  • the free edge 745 Under the impact of blood backflow in the venous vessel 300 (as shown in FIG. 2 ), the free edge 745 can move toward the notch 401 and abut with the venous vessel wall around the notch 401 to form a one-way passage in the venous vessel 300 .
  • the free edge 745 moves toward the sinus region 403 , and the free edge 745 is separated from the venous vessel wall to open a one-way passage in the venous vessel 300 .
  • valve leaflets 74 form an arched structure that blocks backflow.
  • the edge 745 does not abut against the venous vessel wall, thereby reducing the risk of adhesion of the free edge 745 to the vascular wall tissue, and the tiny gap 404 between the free edge 745 and the venous vessel wall does not affect the valve leaflet 74 to block the flow in the backflow. the vast majority.
  • the free edge 745 can be located not only near the area where the gap 401 is located, referring to FIG. .
  • the free edge 745 may also be located in the inner cavity enclosed and formed by the second annular supporting frame 50 , which is not limited in this application.
  • a sinus area 403 is formed on the inner side of the protruding part 41 of the connecting frame 40 , and the circumferential disconnection of the connecting frame 40 forms a gap 401 ; the gap 401 reduces the metal coverage of the protruding part 41 . , reducing the excessive expansion of the venous vessel wall by the protruding portion 41 of the connecting frame 40, thereby reducing the excessive stimulation to the vascular intima.
  • the gap 401 can make the interventional venous valve stent 20 have better flexibility, so that the interventional venous valve stent 20 can more easily pass through complicated blood vessels, thereby reducing the risk of surgery.
  • the sinus area 403 presses the inner wall of the venous blood vessel 300 to bulge out, thereby forming a depression in the area of the sinus area 403 covered by the valve leaflets 74
  • the depression will affect the laminar flow of the blood, so that when the blood bypasses the depression, the change of the flow velocity will cause a sudden shear stress Therefore, a vortex is formed in the area of the sinus region 403 covered by the valve leaflet 74, which is beneficial to the pressure balance of the valve leaflet 74.
  • the free edge 745 of the valve leaflet 74 is in a suspended state under the action of the eddy current and does not fit with the vein wall, In turn, the risk of adhesion can be reduced, and the formed vortex can also avoid the risk of blood flow retention at the root of the valve leaflet 74 to form a thrombus;
  • the inner wall of the venous blood vessel 300 abuts ( FIG. 2 ), so that the backflowing blood forms a vortex in the area of the sinus 403 covered by the valve leaflet 74 , preventing the blood from retreating, and avoiding the risk of blood flow retention at the root of the valve leaflet 74 to form a thrombus.
  • the interventional venous valve stent 20 is a nickel-titanium alloy mesh cylindrical stent, and the interventional venous valve stent 20 exhibits greater rigidity.
  • the interventional venous valve stent 20 After the interventional venous valve stent 20 is implanted in the venous blood vessel 300, the interventional venous valve stent 20 always maintains a fixed shape , the valve body 72 and thus the function of the valve leaflets 74 are not affected due to changes in the pressure of the venous blood vessel 300, and the first annular support frame 30 and the second annular support frame 50 have high radial support force, which can connect the interventional vein
  • the valve stent 20 is better anchored to the venous blood vessel 300, and reduces the stimulation to the intima of the venous blood vessel 300, preventing excessive intimal hyperplasia.
  • the connecting frame 40 is a non-closed mesh stent continuously arranged in its circumferential direction.
  • the so-called “continuous” means that the connecting frame 40 extends continuously for a certain angle in its circumferential direction without being broken.
  • the connecting frame 40 includes a first wave supporting rod 43 with a sinusoidal waveform, and the first wave supporting rod 43 includes a plurality of first wave rods 430 connected end to end, at least part of the first wave rods The middle portion of 430 protrudes outward to form at least a part of the protruding portion 41 .
  • the first wave bar 430 with the outwardly protruding middle portion may form part of the protruding portion 41 , or may form the whole of the protruding portion 41 .
  • the number of the first corrugated support rods 43 is one, the first corrugated support rods 43 are arranged along the circumferential direction of the first annular support frame 30 , and the first corrugated support rods 43 are broken in the circumferential direction to form a gap 401 , the middle of each first wave rod 430 is convex.
  • the first wave supporting rod 43 has a first wave crest 432 close to the first annular supporting frame 30 and a first wave trough 434 far away from the first annular supporting frame 30 . Between the first wave bars 430.
  • the connecting frame 40 further includes a plurality of first connecting rods 45 extending along the axial direction of the connecting frame 40 , and the first connecting rods 45 are arranged between the first wave crest 432 and the first annular supporting frame 30 .
  • each first wave crest 432 of the first wave supporting rod 43 is connected to a first connecting rod 45
  • the end of the first connecting rod 45 away from the first wave supporting rod 43 is connected to the first annular supporting frame 30 .
  • each first connecting rod 45 is gradually inclined outward to connect to the Corresponding to the first wave crest 432 , the first connecting rod 45 is formed as a part of the protruding portion 41 , that is, the first connecting rod 45 is formed as a proximal end portion of the protruding portion 41 .
  • the first connecting rod 45 includes a first vertical section 452 and a first curved section 454, the first vertical section 452 extends along the axial direction of the first annular support frame 30, and the first curved section 454 is formed by the A vertical section 452 is gradually bent outward in the direction from the first wave support rod 43 of the connecting frame 40 to connect with the corresponding first wave crest 432 , and the first curved section 454 forms a part of the protruding portion 41 , that is, the first curved section 454 forms the proximal portion of the protruding portion 41 , and the inner cavity enclosed and formed by the first vertical section 452 has an equal diameter.
  • the first vertical section 452 does not have a convex structure and does not belong to the protruding portion 41 .
  • the connecting frame 40 further includes a plurality of second connecting rods 46 extending along the axial direction of the connecting frame 40 .
  • the wave valleys 434 are connected. Specifically, in the direction from the end of the second connecting rod 46 away from the first wave supporting rod 43 to the end close to the first wave supporting rod 43, each second connecting rod 46 is gradually inclined outward to Connected to the corresponding first troughs 434 , the second connecting rods 46 are formed as part of the protrusions 41 .
  • the opposite end of the second connecting rod 46 is connected to the distal end of the second annular supporting frame 50 .
  • each first wave valley 434 of the first wave supporting rod 43 is connected to a second connecting rod 46
  • the end of the second connecting rod 46 away from the first wave supporting rod 43 is connected to the second annular supporting frame 50 .
  • each second connecting rod 46 is gradually inclined outward so as to be connected to the second annular supporting frame 50.
  • the second connecting rod 46 is formed as a part of the protruding portion 41 , that is, the second connecting rod 46 is formed as a distal end portion of the protruding portion 41 .
  • the second connecting rod 46 includes a second vertical section 462 and a second curved section 464, the second vertical section 462 extends along the axial direction of the second annular support frame 50, and the second curved section 464 is formed by the first
  • the direction from the two vertical sections 462 to the first corrugated support rod 43 of the connecting frame 40 is gradually curved outward to connect to the corresponding first wave valley 434 , and the second curved section 464 forms a part of the protruding portion 41 , that is, the second curved section 464 forms the distal portion of the protruding portion 41 , and the inner cavity enclosed and formed by the second vertical section 462 has an equal diameter.
  • the first vertical section 462 does not have a convex structure and does not belong to the protruding portion 41 .
  • the connecting frame 40 may not include the first connecting rod 45 and the second connecting rod 46 .
  • the first wave crest 432 of the first corrugated support rod 43 may be directly connected to the first annular support frame 30 .
  • the first wave trough 434 of a wave supporting rod 43 can be directly connected to the second annular supporting frame 50 .
  • the number of the first wave support rods 43 is multiple, and the plurality of first wave support rods 43 are arranged along the axial direction of the connection frame 40 .
  • the first wave crests 432 of every two adjacent first wave supporting rods 43 are connected with the corresponding first wave troughs 434 .
  • the first annular support frame 30 and the second annular support frame 50 have a grid structure, and the inner diameter of the grid surrounded by the adjacent two first wave-shaped support rods 43 is larger than that of the first annular support frame 30 and the mesh inner diameter of the second annular support frame 50 .
  • the first annular support frame 30 includes a plurality of second wave support rods 33 with sinusoidal waveforms, and the plurality of second wave support rods 33 are sequentially arranged along the axial direction of the first annular support frame 30 .
  • Each second wave support rod 33 includes a plurality of second wave peaks 332, a plurality of second wave troughs 334, and a second wave rod 330 connecting two adjacent second wave peaks 332 and second wave troughs 334, the first Both ends of the connecting rod 45 are respectively connected to the first wave crest 432 and the second wave trough 334 ;
  • the second trough 334 is connected by the first connecting rod 45 .
  • Each second corrugated support rod 33 is arranged in a circle along the circumference of the first annular support frame 30 , a plurality of second corrugated support rods 33 encloses a first inner cavity 35 extending in the axial direction, and a plurality of second corrugated support rods
  • the rods 33 form an annular grid structure, and every two adjacent second wave supporting rods 33 form a plurality of grid holes 37 .
  • the side of the first annular support frame 30 facing or connected to the connecting frame 40 is in a wave-like structure, and the wave-like structure is in the shape of concave-convex and convex.
  • the bottom is a wave trough.
  • the side of the second annular supporting frame 50 facing or connecting to the connecting frame 40 is in a wave-like structure, and the wave is in the shape of concave-convex volts.
  • the top is a wave crest and the bottom is a wave trough.
  • at least one wave crest at the wave-like structure of the second annular support frame 50 is suspended.
  • the side of the first annular supporting frame 30 facing or connecting to the connecting frame 40 a has a wave-like structure, and the wave-like structure is in the shape of concave-convex undulations.
  • the top of the wave-like structure is a wave crest and a bottom.
  • the side of the second annular supporting frame 50 facing or connecting to the connecting frame 40 a is in a wave-like structure, and the wave is in the shape of concave-convex volts.
  • the wave-like structure The top is a wave crest and the bottom is a wave trough.
  • At the gap 401 at least one wave crest at the wave-like structure of the second annular support frame 50 is suspended.
  • the first annular support frame 30 is connected by three second wave-shaped support rods 33 along the axial direction of the first annular support frame 30 .
  • each of the second corrugated support rods 33 is made by laser engraving of nickel-titanium alloy, and the number of sine waves of the second corrugated support rods 33 is nine. In other embodiments, the number of the second wave supporting rods 33 and the number of the sine waves may be other numbers.
  • the connecting frame 40 is provided with a second inner cavity 47 that communicates with the first inner cavity 35 , and each adjacent two first connecting rods 45 and the first corrugated support rod 43 and the corresponding second corrugated support The rods 33 are surrounded by mesh holes 48 ;
  • the connecting skeleton 40 has a gradual change section 470. In the direction from the two sides of the gradual change section 470 to the middle of the gradual change section 470, the inner diameter of the second lumen 47 (ie the gradual change section 470) gradually increases, and the gradual change section 470 It can be understood as corresponding to the protruding portion 41 in the connecting frame 40 ;
  • the second annular support frame 50 includes a plurality of third wave support rods 53 with sinusoidal waveforms, and the plurality of third wave support rods 53 are sequentially arranged along the axial direction of the second annular support frame 50; each The third wave support rod 53 includes a plurality of third wave peaks 532, a plurality of third wave troughs 534, and a third wave rod 530 connecting two adjacent third wave peaks 532 and the third wave troughs 534.
  • each first wave trough 434 of the first wave supporting rod 43 is adjacent to the third wave crest 53 of the third wave supporting rod 53 adjacent to the first wave supporting rod 43 .
  • 532 is connected by the second connecting rod 46 .
  • Each third corrugated support rod 53 is arranged in a circle along the circumferential direction of the second annular support skeleton 50 , a plurality of third corrugated support rods 53 constitute an annular grid structure, and every two adjacent third waved support rods 53 A plurality of mesh holes 57 are formed, and the diameter of each mesh hole 57 of the second annular supporting frame 50 is smaller than that of the mesh hole 48 .
  • the second annular support frame 50 is connected by three third wave-shaped support rods 53 along the axial direction of the second annular support frame 50 .
  • each third wave support rod 53 is made by laser engraving of NiTi alloy, and the number of sine waves of the third wave support rod 53 is nine. In other embodiments, the third wave support rod 53 and the number of the sine waves may be other numbers.
  • the second annular support frame 50 has a third inner cavity 55 , that is, a plurality of third corrugated support rods 53 enclose a third inner cavity 55 extending in the axial direction, and each adjacent two third corrugated support rods 53 constitute a number of Grid holes 57.
  • Each adjacent two second connecting rods 46 , the first corrugated supporting rod 43 and the corresponding third corrugated supporting rod 53 also enclose a grid hole 48 .
  • the third inner cavity 55 communicates with the second inner cavity 47 , and the diameter of the mesh hole 48 is larger than the diameter of the mesh hole 57 of the second annular supporting frame 50 .
  • the inner diameter of the end of the gradual change section 470 close to the first annular supporting frame 30 is equal to the inner diameter of the first lumen 35
  • the inner diameter of the end of the gradual change section 470 close to the second annular supporting frame 50 is equal to the inner diameter of the third lumen 55 .
  • the middle portion of the first wave rod 430 is convex so that the first wave support rod 43 is enclosed to form at least part of the gradual change section 470 .
  • the inner diameter of the first lumen 35 is equal to the inner diameter of the third lumen 55 .
  • the inner diameter values of the opposite sides of the gradual change section 470 are equal to the inner diameter value of the first inner cavity 35 and the inner diameter value of the second inner cavity 55 .
  • the first connecting rods 45 are gradually inclined outward to be connected to the corresponding first wave crests 432
  • the second connecting rods 46 are gradually inclined toward the corresponding first wave crests 432 .
  • the first connecting rod 45 , the first wave supporting rod 43 , and the second connecting rod 46 are enclosed to form a gradual change section 470 .
  • first connecting rod 45 includes the first vertical section 452 and the first curved section 454, and the second connecting rod 46 includes the second vertical section 462 and the second curved section 464, then the first connecting rod 45 has a A portion (ie, the first curved section 454 ), a portion of the second wave rod 46 (ie, the second curved section 464 ), and the first wave support rod 43 are enclosed to form a gradual change section 470 .
  • the maximum outer diameter D1 of the protruding portion 41 is larger than the outer diameter D2 of the first annular support frame 30 and the outer diameter D3 of the second annular support frame 50 .
  • the outer diameter D2 of the first annular supporting frame 30 is equal to the outer diameter D3 of the second annular supporting frame 50;
  • the outer diameter D2 of the annular support frame 30 protrudes by 1.5 mm to 2.5 mm.
  • the outer diameter D2 of the first annular support frame 30 and the outer diameter D3 of the second annular support frame 50 may not be equal.
  • the axial length L1 of the connecting frame 40 may be the same as or different from the axial length L2 of the first annular support frame 30 and the axial length L3 of the second annular support frame 50;
  • the axial length L1 , the axial length L2 of the first annular support frame 30 , and the axial length L3 of the second annular support frame 50 are equal, and are all 10 mm.
  • the first annular supporting frame 30 , the connecting frame 40 , and the second annular supporting frame 50 may be a Nitinol laser-engraved one-piece bracket.
  • the width of the first wave rod 430 , the second wave rod 330 , the third wave rod 530 , the first connecting rod 45 and the second connecting rod 46 of the interventional venous valve stent 20 is 0.3 mm, and the rod thickness is 0.35 mm ;
  • the total axial length of the interventional venous valve stent 20 is about 30 mm.
  • first annular support frame 30 , the connection frame 40 , and the second annular support frame 50 may be laser-engraved from different nickel-titanium alloys and then fixed and connected into one.
  • the axial direction of the first annular supporting frame 30 , the axial direction of the connecting frame 40 and the axial direction of the second annular supporting frame 50 are parallel to each other.
  • the axis of the first annular support frame 30 coincides with the axis of the second annular support frame 50 . It should be noted that the so-called natural state, that is, the intervening venous valve stent 20 is in a released state that is not subjected to external force in the radial direction.
  • the axis of the first annular support frame 30 , the axis of the connection frame 40 and the axis of the second annular support frame 50 are coincident.
  • the two parts obtained by dividing the middle of the venous valve stent 20 by the reference plane ⁇ and the two parts obtained by dividing the lumen of the venous valve stent 20 by the reference plane ⁇ are both symmetrical with respect to the reference plane ⁇
  • the normal direction of the reference plane ⁇ is parallel to the axial direction of the first annular support frame 30 or the second annular support frame 50
  • the set of all points in the connection frame 40 used to form the maximum inner diameter of the connection frame 40 is located on the reference plane within ⁇ .
  • the two parts of the venous valve stent 20 divided by the reference plane ⁇ are symmetrical with respect to the reference plane ⁇ , the reference plane ⁇ and the first annular support frame 30 or the second annular support frame 50
  • the axes are parallel, and the reference plane ⁇ is located in the middle of the notch 401 .
  • the maximum opening angle C of the notch 401 in the circumferential direction of the connecting frame 40 ranges from 90° to 180°; the protruding portion 41 extends from one side of the connecting frame 40 to the The opposite side, that is, the opposite sides of the protruding portion 41, the first annular supporting frame 30 is close to the connecting frame 40 and is not connected to the first connecting rod 45, and the second annular supporting frame 50 is adjacent to the connecting frame 40.
  • the part connecting the second connecting rod 46 forms a gap 401 .
  • the support body and the connecting frame 40 are made of braided wires, that is, the first annular support frame 30 , the connecting frame 40 and the second annular support frame 50 are made of braided wires.
  • the interventional venous valve stent 20 is woven from a superelastic nickel-titanium wire, and the superelastic nickel-titanium alloy wire can be selected from a wire diameter (ie, diameter) ranging from 0.1 mm to 0.6 mm.
  • the middle portion of the connecting frame 40 protrudes outward to form a protruding portion, and the inner side of the protruding portion forms a sinus area; specifically, the sinus area is obtained by a mold inserted into the connecting frame 40 after being shaped and heat-treated.
  • the protruding part thus provided is a whole circle of annular shape, and the protruding part of the whole circle will reduce the anchoring force of both ends of the interventional venous valve stent 20, so a gap can be formed by cutting a part of the protruding part of the whole circle, In this way, the anchoring force at both ends of the interventional venous valve stent 20 is increased.
  • the cross-sectional shapes of the first annular supporting frame 30 and the second annular supporting frame 50 are oval or shuttle-shaped. It should be noted that, in order to clearly define the cross section, the normal direction of the cross section is parallel to the axial direction of the first annular support frame 30 and the axial direction of the second annular support frame 50 .
  • the flap body 72 includes a first flap 721 attached to the inner surface of the first corrugated support rod 43 and attached to the inner surface of the plurality of first connecting rods 45
  • the second flap 723, and the third flaps 725 that fit the inner surfaces of the second connecting rods 46.
  • the first flap 721, the second flap 723 and the third flap 725 can be an integrally formed structure, and the flap body 72 is connected to the inner side of the connecting frame 40 by suturing, bonding or hot pressing, so that the opposite ends of the flap body 72 are connected.
  • the edges are respectively connected to the intersection of the first annular supporting frame 30 and the connecting frame 40 and the intersection of the second annular supporting frame 50 and the connecting frame 40 .
  • the edge of the second flap 723 away from the first flap 721 is connected to the intersection of the first annular support frame 30 and the connecting frame 40, and the edge of the third flap 725 away from the first flap 721 is connected to the second flap 721.
  • the intersection of the annular support frame 50 and the connection frame 40 The opposite sides of the valve body 72 extend to the opposite sides of the connecting frame 40 , that is, the opposite side edges of the valve body 72 cover the opposite sides of the notch 401 .
  • the first corrugated support rod 43 fixed on the valve body 72 can increase the support strength, prevent the connecting frame 40 from being deformed due to the compression of the venous blood vessel, and prevent the valve leaflet 74 from losing the function of a one-way valve.
  • first flap 721 , the second flap 723 and the third flap 725 may be separate structures, and the first flap 721 , the second flap 723 and the third flap 725 are sutured, Adhesion or thermocompression is connected to the first corrugated support rod 43 , the first connecting rod 45 and the second connecting rod 46 , and the first flap 721 , the second flap 723 and the third flap 725 are integrated.
  • valve leaflets 74 are connected to the inner side of the valve body 72 (ie, the side away from the connecting frame 40 ) by suture, bonding or thermocompression, so as to construct the flow of blood when passing through the venous valve prosthesis 100 .
  • the leaflet 74 and the valve body 72 enclose a first area 75 and a second area 76, the first area 75 corresponds to a part of the sinus area 403, the second area 76 corresponds to another part of the sinus area 403, the first area 75 and the second area 76 are located on opposite sides of the valve leaflets 74 , and the valve leaflets 74 cover the first area 75 .
  • One of the first region 75 and the second region 76 is in communication with the first inner cavity 35 of the first annular support frame 30 .
  • the first area 75 is the area that communicates with the first inner cavity 35 of the first annular support frame 30 after the valve leaflet 74 is arched
  • the second area 76 is the area where the valve leaflet 74 is arched and communicated with the second annular supporting frame 30 .
  • the leaflet 74 and the valve body 72 can also be integrally formed.
  • the valve assembly 70 further includes a membrane disposed on the peripheral wall of the support body, the membrane can be disposed on the inner surface or the outer surface of the support body, and each membrane is connected to the valve body 72 .
  • the coating includes a first coating 77 disposed on the peripheral wall of the first annular support frame 30 and a second coating 78 disposed on the second annular supporting frame 50 .
  • the first coating 77 is sutured, Adhesion or heat pressing to the first annular support frame 30, and the side of the first covering film 77 close to the connecting frame 40 is connected to the valve body 72; the second covering film 78 is sutured, glued or heat pressed to the second ring
  • the frame 50 is supported, and the side of the second covering film 78 close to the connection frame 40 is connected to the valve body 72 . Since the first annular support frame 30 is fixed on the first film 77 and the second annular support frame 50 is fixed on the second film 78, the first annular support frame 30 and the second annular support frame 50 use It is made of super-elastic nickel-titanium alloy.
  • the first annular supporting frame 30 and the second annular supporting frame 50 elastically abut the venous blood vessel 300 respectively.
  • the anchor after the first annular support frame 30 and the second annular support frame 50 are implanted into the venous blood vessel is strengthened. Concentration.
  • first covering 77, the valve body 72 and the second covering 78 are integrally formed; or the leaflet 74, the first covering 77, the valve body 72 and the second covering 78 are integrally formed .
  • valve leaflet 74, the first covering 77, the valve body 72 and the second covering 78 are all made of polyester, polytetrafluoroethylene, polyurethane, medical silicone, polyester, biological valve, pericardium or other implantable medical materials. production. .
  • the venous valve prosthesis 100 is implanted in the proper position of the lumen 301 of the venous blood vessel 300 through the delivery device, and the first annular support frame 30 and the second annular support frame 50 are anchored to the vein
  • the connecting frame 40 abuts against the inner wall of the venous blood vessel 300 and protrudes outward.
  • the second annular supporting frame 50 better anchors the venous blood vessel 300 , so that the venous valve prosthesis 100 is less likely to be displaced after the venous blood vessel 300 is implanted.
  • the venous valve is The prosthesis 100 has a certain flexibility as a whole, the venous valve prosthesis 100 is easily bent at the connection frame 40 , and the venous valve prosthesis 100 can more easily pass through complicated blood vessels, thereby reducing the risk of surgery. As shown in FIG.
  • the mesh holes 48 of the connection frame 40 refer to the two first wave rods 430 adjacent to the first wave support rod 43 and the two first connections connected to the two first wave rods 430
  • the grid holes 37 of the first annular supporting frame 30 refer to Among the two adjacent second wave supporting rods 33 , the two second wave rods 330 adjacent to one second wave supporting rod 33 are in phase with the two second wave rods 330 corresponding to the other second wave supporting rod 33 .
  • the closed space enclosed by the connection; the mesh holes 57 of the second annular support frame 50 refer to the adjacent two third wave support rods 53 , and two adjacent third wave support rods 53 of one third wave support rod 53 are adjacent to each other.
  • a closed space is formed after the wave rod 530 is connected with two third wave rods 530 corresponding to another third wave support rod 53 .
  • the opening area of the mesh hole 48 is larger than the opening area of the mesh hole 37 and the opening area of the mesh hole 57 .
  • the blood in the lumen 301 of the venous blood vessel 300 flows downstream from the proximal end to the distal end, that is, from the third lumen 55 of the second annular support frame 50 to the first lumen 35 of the first annular support frame 30,
  • the downstream blood impinges on the valve leaflet 74 and moves to the side away from the notch 401 , and the valve leaflet 74 is separated from the inner wall of the venous blood vessel 300 to open the one-way passage of the venous valve prosthesis 100 (as shown in FIG. 1 ).
  • the valve leaflet 74 is arched by the impact of the blood backflow in the venous blood vessel 300 (as shown in FIG.
  • the valve leaflet 74 is moved to the gap 401 by the impact of the blood backflow and abuts against the inner wall of the venous blood vessel 300 around the gap 401 ,
  • the valve leaflet 74 closes the lumen of the venous vessel 300 to avoid blood backflow; at the same time, a vortex area is formed in the first area 75 to effectively prevent local thrombosis.
  • the valve leaflet 74 is pushed by the downstream blood and moves to the side away from the gap 401 , referring to FIG.
  • the valve leaflet 74 squeezes out the blood in the first region 75 , so that the blood in the first region 75 flows to the first lumen 35; therefore, based on the existence of the second region 76, when the backflow disappears, the downstream one-way passage can be quickly opened to increase the downstream blood flow.
  • the venous valve prosthesis 100 is provided with a visualization structure.
  • one of the first annular support frame 30 , the connection frame 40 and the second annular support frame 50 is provided with a visualization structure, or the first annular support frame 30 , the connecting frame 40 and the second annular support frame 50
  • Two of the annular supporting frame 30 , the connecting frame 40 and the second annular supporting frame 50 are provided with a developing structure, or the first annular supporting frame 30 , the connecting frame 40 and the second annular supporting frame 50 are respectively provided with a developing structure structure.
  • the imaging structure is the imaging wire or imaging point wound on the venous valve prosthesis 100 continuously or intermittently, or the interventional venous valve stent 20 is made of an alloy doped with imaging materials, for example, the nickel-titanium alloy wire is made of Nitinol wire of tantalum.
  • one of the first wave support rod 43 , the second wave support rod 33 adjacent to the connection frame 40 and the third wave support rod adjacent to the connection frame 40 encloses at least one circle of developing wires or development points.
  • the developer material includes, but is not limited to, gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.
  • the first covering film 77 and/or the second covering film 78 are provided with at least one circle of developing wires or developing dots, and the developing wires or developing dots are fixed on the on the first coating 77 and/or the second coating 78 .
  • the structure of the venous valve prosthesis 100a provided by the second embodiment of the present application is similar to that of the first embodiment, the difference is that the venous valve prosthesis 100a is the venous valve prosthesis of the first embodiment
  • the first coating 77 and the second coating 78 are omitted.
  • the valve assembly 70 only includes the valve body 72 disposed on the inner side of the connecting frame 40 and the valve leaflet 74 connected to the inner side of the valve body 72 .
  • the structure of the venous valve prosthesis provided by the third embodiment of the present application is similar to that of the first embodiment, the difference is: the connecting skeleton of the interventional venous valve stent 20a in the third embodiment
  • the structure of 40a is different from the structure of the connection frame 40 of the interventional venous valve stent 20 in the first embodiment: specifically, the connection frame 40a includes a plurality of support rods 435, and the plurality of support rods 435 extend along the first annular support frame 30 or the second support frame 30.
  • the support frame 50 extends in the axial direction and is arranged at intervals along the circumferential direction of the first annular support frame 30 or the second support frame 50.
  • two adjacent The spaced regions between the support rods 435 form the notches 401 .
  • the gap 401 formed in the spaced area between the two adjacent support rods 435 with the largest distance can be used for the valve leaflet 74 to pass through to abut against the venous vessel wall, and the middle part of at least one support rod 435 is bent outward to form a protrusion Section 41.
  • each support rod 435 includes a middle bending section 436 , a proximal vertical section 437 disposed at the proximal end of the middle bending section 436 , and a distal vertical section disposed at the distal end of the middle bending section 436 438 , one end of the proximal vertical section 437 away from the middle bent section 436 is connected to the first annular support frame 30 , and one end of the distal vertical section 438 away from the middle bent section 436 is connected to the second annular support frame 50 .
  • the proximal vertical section 437 extends along the axial direction of the first annular support frame 30
  • the distal vertical section 438 extends along the axial direction of the second annular support frame 50
  • the middle of the middle bending section 436 is bent outwards.
  • a plurality of middle bent sections 436 form a protruding portion 41
  • the inner side of the protruding portion 41 forms a sinus region 403
  • the valve assembly 70 is disposed in the sinus region 403 .
  • the proximal vertical sections 437 of the plurality of support rods 435 are respectively connected to the second troughs 334 of the adjacent second wave supporting rods 33
  • the distal vertical sections 438 are respectively connected to the third wave crests 532 of the adjacent third wave supporting rods 53 .
  • a gap 401 is formed between the second trough 334 of the adjacent second wave support rod 33 and the third wave crest 532 of the third wave support rod 53 that is not connected by the support rod 435 .
  • the number of the support rods 435 is six, which are arranged at intervals within a range of 270 degrees in the circumferential direction of the interventional venous valve stent 20a.
  • the circumferential interval angle between two adjacent support rods 435 is 45 degrees.
  • the 90-degree interval in which the support rods 435 are not arranged in the interventional venous valve stent 20a forms an available valve
  • the notch 401 through which the leaf 74 passes, that is, the opening circumferential angle of the notch 401 is 90 degrees.
  • the structure of the venous valve prosthesis 100 b provided by the fourth embodiment of the present application is similar to the structure of the venous valve prosthesis 100 of the first embodiment, the difference is that the venous valve prosthesis in the fourth embodiment
  • the prosthesis 100b is based on the venous valve prosthesis 100 of the first embodiment and omits the second annular support frame 50 and the second membrane 78, that is, the interventional venous valve stent only includes the first annular support frame 30 and the connection.
  • the leaflet 74 is sutured, bonded or hot-pressed to the valve body 72
  • the first covering 77 is sutured, bonded or thermo-compressed to the first annular support frame 30
  • the valve body 72 is connected to the first covering 77 .
  • the venous valve prosthesis 100b omits the second annular support frame 50 and the second membrane 78 to save the manufacturing cost. It should be understood that, in this embodiment, the first covering film 77 may also be omitted.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种介入静脉瓣支架（20，20a），包括支撑体及连接骨架（40，40a），支撑体包括第一环状支撑骨架（30），连接骨架（40，40a）连接于第一环状支撑骨架（30）的端部，连接骨架（40，40a）沿第一环状支撑骨架（30）的周向设置并在连接骨架（40，40a）的周向断开形成缺口（401），连接骨架（40，40a）的至少部分外凸形成凸出部（41），凸出部（41）的内侧形成窦区（403）。缺口（401）能使介入静脉瓣支架（20，20a）具有较好的柔顺性，使介入静脉瓣支架（20，20a）更容易通过迂回复杂的血管，降低手术风险；瓣叶（74）使得回流的血液在窦区（403）被瓣叶（74）覆盖的区域形成涡流，防止血液回退，从而使静脉瓣假体（100，100a，100b）的临床效果较好。还提供一种设有介入静脉瓣支架（20，20a）的静脉瓣假体（100，100a，100b）。

Description

介入静脉瓣支架及静脉瓣假体 技术领域
本申请涉及可植入血管技术领域，尤其涉及介入静脉瓣支架及设置有所述介入静脉瓣支架的静脉瓣假体。
背景技术
静脉外科疾病是外科常见病，多发生于下肢，其主要临床表现为静脉曲张、肢体肿胀、足靴区皮肤营养障碍性病变，如皮炎，色素沉着和溃烂形成等。其主要病理原因是，在致病因素作用下静脉瓣膜失去单向开放的基本功能。静脉疾病轻者妨碍生活和工作能力，重者可致程度不同的病残。因此，下肢静脉瓣膜疾病的治疗日益受到重视。目前，临床上对该疾病大部分仍采用保守治疗，如药物治疗、压力泵等，外科手术治疗如股静脉瓣膜修复重建术等，临床效果并不理想。特别是当静脉瓣膜严重破坏或先天性无瓣症的患者，静脉瓣膜移植似乎是唯一可选择的方法，目前临床采用的是自体带瓣膜的静脉瓣假体，然而，由于相关技术中的静脉瓣假体植入血管后的锚定力差、柔顺性不足的原因，使得静脉瓣假体的临床效果并不理想。如何提供一种锚定性能好且柔顺性好的静脉瓣假体，是本领域亟需解决的技术问题。
发明内容
本申请的目的在于提供一种临床效果较好的静脉瓣假体及介入静脉瓣支架。
为了解决上述技术问题，本申请提供了一种能够径向压缩和扩张的介入静脉瓣支架，包括支撑体及连接骨架，所述支撑体包括第一环状支撑骨架，所述连接骨架连接于所述第一环状支撑骨架的端部，所述连接骨架沿所述第一环状支撑骨架的周向设置并在所述连接骨架的周向断开形成缺口，所述连接骨架的至少部分外凸形成凸出部，所述凸出部的内侧形成窦区。
本申请还提供一种静脉瓣假体，用于植入静脉血管，所述静脉瓣假体包括介入静脉瓣支架以及瓣膜组件，所述瓣膜组件包括连接于所述连接骨架内侧的瓣叶，所述瓣叶罩设于所述窦区的至少部分并用于构建所述静脉血管内的单向通路。
本申请提供的静脉瓣假体的连接骨架上的缺口减少了连接骨架的凸出部对静脉血管壁过度的扩张，且缺口能使介入静脉瓣支架具有较好的柔顺性，使介入静脉瓣支架更容易通过迂回复杂的血管，降低手术风险；另外，瓣叶在涡流的作用下处于悬浮状态不与静脉壁贴合，进而可以减少粘合的风险，并且形成的涡流还可以避免瓣叶根部血流滞留形成血栓的风险；瓣叶在静脉血管内血液回流的冲击下向缺口移动并与缺口周围的静脉血管内壁抵接，使得回流的血液在窦区被瓣叶覆盖的区域形成涡流，防止血液回退，且避免瓣叶根部血流滞留形成血栓的风险；从而使静脉瓣假体的临床效果较好。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请第一实施例提供的静脉瓣假体的使用状态示意图；
图2是本申请第一实施例提供的静脉瓣假体的抗返流状态示意图；
图3是本申请第一实施例提供的静脉瓣假体的立体结构示意图；
图4是图3中的静脉瓣假体的主视图；
图5是本申请第一实施例提供的静脉瓣假体的其中一使用状态示意图；
图6是本申请第一实施例提供的静脉瓣假体的又一使用状态示意图；
图7是图3中的静脉瓣假体的介入静脉瓣支架的左视图；
图8是图3中的介入静脉瓣支架的正视图；
图9是图3中的瓣膜组件的立体分解结构示意图；
图10是图9中的瓣膜组件的立体组装示意图；
图11是本申请第二实施例提供的静脉瓣假体的立体结构示意图；
图12是本申请第三实施例提供的介入静脉瓣支架的主视图；
图13是图12中的介入静脉瓣支架的左视图；
图14是本申请第四实施例提供的介入静脉瓣支架的立体结构示意图；
图15是图14中的介入静脉瓣支架的主视图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
此外，以下各实施例的说明是参考附加的图示，用以例示本申请可用以实施的特定实施例。本申请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图式的方向，因此，使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗指所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。用语“自然状态”是指，装置或元件在不受外部力的状态，外部力例如拉力或压力等。
在本申请的描述中，本申请所述“近端”是指靠近心脏位置的一端，所述“远端”为远离心脏位置的一端，该定义只是为了表述方便，并不能理解为对本申请的限制。
请一并参阅图1和图2，本申请提供静脉瓣假体100，用于植入静脉血管300，以用于构建静脉血管300内的单向通路，避免血液返流。图1示意了静脉瓣假体100的使用状态示意图，此时在近端至远端的顺流血流冲击下，静脉瓣假体100的血流通路被打开，图2示意了静脉瓣假体100的抗返流状态示意图，此时在远端至近端的逆流血流冲击下，静脉瓣假体100的血流通路被关闭。
请参阅图1至图4，静脉瓣假体100包括介入静脉瓣支架20以及瓣膜组件70，介入静脉瓣支架20为网筒结构并可径向压缩和扩张。介入静脉瓣支架20包括支撑体和连接骨架40，所述支撑体包括第一环状支撑骨架30及第二环状支撑骨架50，连接骨架40位于第一环状支撑骨架30与第二环状支撑骨架50之间；具体地，第一环状支撑骨架30连接于连接骨架40的近端，第二环状支撑骨架50连接于连接骨架40的远端，即连接骨架40连接于第一环状支撑骨架30的远端部与第二环状支撑骨架50的近端部 之间。连接骨架40沿第一环状支撑骨架30和第二环状支撑骨架50的周向设置，并在连接骨架40的周向断开形成缺口401，连接骨架40的至少部分外凸形成凸出部41，凸出部41的内侧形成窦区403。具体地，凸出部41是由连接骨架40的侧壁大致沿径向远离连接骨架40的内腔外凸形成。需要说明的是，所谓“窦区”，即连接骨架40的内表面产生凹陷的区域，也可以理解为连接骨架40围合形成的内腔中局部内径增大的区域。
瓣膜组件70包括连接于连接骨架40内侧的瓣体72和连接于瓣体72内侧的瓣叶74，瓣叶74覆盖窦区403的至少部分。本实施例中，瓣体72贴合于连接骨架40的内表面，瓣叶74连接于瓣体72背离连接骨架40的侧面；具体地，瓣体72通过缝合、粘接或热压于连接骨架40，瓣叶74其中一边缘通过缝合、粘接或热压于瓣体72，使瓣叶74与瓣体72被瓣叶74所覆盖的部分围成横截面大致呈V形的涡流容置空间，所述横截面平行于介入静脉瓣支架20的轴向，需要说明的是，上述的V形的涡流容置空间的V形横截面仅仅是一个具体的实施例，并不构成对本申请中的涡流容置空间形状的限定，涡流容置空间的形状可以是本领域技术人员可以想到的规则几何图形或非规则几何图形。
静脉瓣假体100植入静脉血管300后，介入静脉瓣支架20与静脉血管300的内膜贴合，使得介入静脉瓣支架20稳定地锚定于静脉血管300，防止静脉血管300内的血液从介入静脉瓣支架20与静脉血管300的内膜之间漏出，即血液全部在介入静脉瓣支架20的内腔中流动。参考图2，当静脉血管300内的血液自远端向近端流动时，瓣叶74在血流的冲击下朝缺口401移动，直至瓣叶74远离瓣体72的一侧与缺口401周围的静脉血管300内壁抵接，瓣叶74闭合静脉血管300，有效避免血液返流；参考图1，当静脉血管300内的血液自近端向远端流动时，血流冲击瓣叶74朝远离缺口401的一侧移动而开通静脉血管300的单向通路。
为进一步解释说明，请参考图3和图4所示，瓣叶74包括固定缘742和自由缘745，固定缘742固定连接于瓣体72，自由缘745自由悬空。在静脉血管300(如图2)内血液回流的冲击下，自由缘745能够向缺口401移动并与缺口401周围的静脉血管壁抵接，以形成静脉血管300内的单向通路。在静脉血管300内血液顺流的冲击下(如图1)，自由缘745向窦区403移动，自由缘745与静脉血管壁分离以开通静脉血管300内的单向通路。
需要说明的是，在静脉血管300内血液的回流冲击下，瓣叶74形成阻挡回流的拱起结构，参考图5，自由缘745与静脉血管壁之间可以存在微小的间隙404，此时自由缘745不抵接于静脉血管壁，从而可减少自由缘745与血管壁组织粘合的风险，自由缘745与静脉血管壁之间微小的间隙404并不影响瓣叶74阻挡回流血流中的绝大部分。另外，在静脉血管300内血液的回流冲击下，自由缘745除了可以位于缺口401所在区域附近之外，参考图6，自由缘745还可以位于第一环状支撑骨架30围合形成的内腔。在其他实施例中，自由缘745也可以位于第二环状支撑骨架50围合形成的内腔之中，本申请在此不作限定。
本申请提供的静脉瓣假体100的连接骨架40的凸出部41的内侧形成窦区403，且连接骨架40的周向断开形成缺口401；缺口401减少了凸出部41的金属覆盖率，减少了连接骨架40的凸出部41对静脉血管壁过度的扩张，进而减少了对血管内膜的过度刺激。且缺口401能使介入静脉瓣支架20具有较好的柔顺性，使介入静脉瓣支架20更容易通过迂回复杂的血管，降低手术风险。
其次，在静脉血管300内的顺流血液沿单向通路流动过程中(图1)，窦区403挤压静脉血管300 的内壁外凸，从而在窦区403被瓣叶74覆盖的区域形成凹陷，当静脉血管300内的血液沿图1所示的方向流动时，所述凹陷会影响血液的层流流动，从而在血液绕过所述凹陷时，会因流速的变化而导致切应力的急骤变化，因此在窦区403被瓣叶74覆盖的区域形成涡流，有利于瓣叶74的压力平衡，此时瓣叶74的自由缘745在涡流的作用下处于悬浮状态不与静脉壁贴合，进而可以减少粘合的风险，并且形成的涡流还可以避免瓣叶74根部血流滞留形成血栓的风险；瓣叶74在静脉血管300内血液回流的冲击下向缺口401移动并与缺口401周围的静脉血管300内壁抵接(图2)，使得回流的血液在窦区403被瓣叶74覆盖的区域形成涡流，防止血液回退，且避免瓣叶74根部血流滞留形成血栓的风险。
另外，介入静脉瓣支架20为镍钛合金网柱形支架，介入静脉瓣支架20呈现较大的刚性，在静脉血管300内植入介入静脉瓣支架20后，介入静脉瓣支架20始终保持固定形状，不因静脉血管300压力的变化影响瓣体72进而影响瓣叶74的功能，且第一环状支撑骨架30和第二环状支撑骨架50具有较高的径向支撑力，能将介入静脉瓣支架20更好的锚定于静脉血管300，并减轻对静脉血管300内膜的刺激，防止内膜过度增生。
在一实施例中，连接骨架40为在其周向上连续设置的非封闭的网状支架，所谓“连续”，即连接骨架40在其周向连续延伸一定角度而不断开。具体地，如图7及图8所示，连接骨架40包括正弦波形的第一波形支撑杆43，第一波形支撑杆43包括首尾相连的多个第一波杆430，至少部分第一波杆430的中部外凸形成凸出部41的至少一部分。即中部外凸的第一波杆430可形成凸出部41的部分，也可形成凸出部41的全部。本实施例中，第一波形支撑杆43的数量为一个，第一波形支撑杆43沿第一环状支撑骨架30的周向设置，且第一波形支撑杆43在周向断开形成缺口401的部分，每一第一波杆430的中部外凸。
第一波形支撑杆43具有靠近第一环状支撑骨架30的第一波峰432和远离第一环状支撑骨架30的第一波谷434，第一波峰432和第一波谷434皆形成于相邻两个第一波杆430之间。连接骨架40还包括沿连接骨架40的轴向延伸的多个第一连接杆45，第一连接杆45设于第一波峰432和第一环状支撑骨架30之间。本实施例中，第一波形支撑杆43的每一第一波峰432连接一个第一连接杆45，第一连接杆45远离第一波形支撑杆43的端部连接于第一环状支撑骨架30。
优选地，在由第一连接杆45靠近第一环状支撑骨架30的一端至远离第一环状支撑骨架30的一端的方向上，每一第一连接杆45逐渐向外倾斜，以连接于对应的第一波峰432，第一连接杆45形成为凸出部41的一部分，即第一连接杆45形成为凸出部41的近端部分。本实施例中，第一连接杆45包括第一竖直段452和第一弯曲段454，第一竖直段452沿第一环状支撑骨架30的轴向延伸，第一弯曲段454由第一竖直段452至连接骨架40的第一波形支撑杆43方向逐渐向外弯曲，以连接于对应的第一波峰432，第一弯曲段454形成凸出部41的一部分，即第一弯曲段454形成凸出部41的近端部分，而第一竖直段452围合形成的内腔等径变化，第一竖直段452并不具有外凸的结构而不属于凸出部41。
本实施例中，连接骨架40还包括沿连接骨架40的轴向延伸的多个第二连接杆46，第二连接杆46的一端与连接骨架40中远离第一环状支撑骨架30的第一波谷434连接，具体地，在由第二连接杆46远离第一波形支撑杆43的一端至靠近第一波形支撑杆43的一端的方向上，每一第二连接杆46逐渐向外倾斜，以连接于对应的第一波谷434，第二连接杆46形成为凸出部41的一部分。第二连接杆46相对的另一端与第二环状支撑骨架50的远端连接。具体地，第一波形支撑杆43的每一第一波谷434连接一 个第二连接杆46，第二连接杆46远离第一波形支撑杆43的端部连接于第二环状支撑骨架50。
优选地，在由第二连接杆46靠近第二环状支撑骨架50的一端至远离第二环状支撑骨架50的一端的方向上，每一第二连接杆46逐渐向外倾斜，以连接于对应的第一波谷434，第二连接杆46形成为凸出部41的一部分，即第二连接杆46形成为凸出部41的远端部分。本实施例中，第二连接杆46包括第二竖直段462和第二弯曲段464，第二竖直段462沿第二环状支撑骨架50的轴向延伸，第二弯曲段464由第二竖直段462至连接骨架40的第一波形支撑杆43方向逐渐向外弯曲，以连接于对应的第一波谷434，第二弯曲段464形成凸出部41的一部分，即第二弯曲段464形成凸出部41的远端部分，而第二竖直段462围合形成的内腔等径变化，第一竖直段462并不具有外凸的结构而不属于凸出部41。
在其他实施例中，连接骨架40可以不包括第一连接杆45和第二连接杆46，此时第一波形支撑杆43的第一波峰432可以直接连接于第一环状支撑骨架30，第一波形支撑杆43的第一波谷434可以直接连接于第二环状支撑骨架50。
在其他实施例中，第一波形支撑杆43的数量为多个，多个第一波形支撑杆43沿连接骨架40的轴向排列。每相邻的两个第一波形支撑杆43的第一波峰432与对应的第一波谷434连接。在其他实施例中，第一环状支撑骨架30和第二环状支撑骨架50具有网格结构，相邻的两个第一波形支撑杆43围成的网格内径大于第一环状支撑骨架30的网格内径及第二环状支撑骨架50的网格内径。
如图7及图8所示，第一环状支撑骨架30包括多个正弦波形的第二波形支撑杆33，多个第二波形支撑杆33沿第一环状支撑骨架30的轴向顺序排列；每一第二波形支撑杆33包括多个第二波峰332、多个第二波谷334、以及连接相邻两个第二波峰332和第二波谷334之间的第二波杆330，第一连接杆45的两端分别连接第一波峰432与第二波谷334；即第一波形支撑杆43的每一第一波峰432与邻近第一波形支撑杆43的第二波形支撑杆33相邻的第二波谷334通过第一连接杆45连接。每一第二波形支撑杆33沿第一环状支撑骨架30的周向设置一圈，多个第二波形支撑杆33围成沿轴向延伸的第一内腔35，多个第二波形支撑杆33构成环状网格结构，每相邻的两个第二波形支撑杆33构成若干网格孔37。
如图7所示，第一环状支撑骨架30朝向或连接于连接骨架40的一侧呈波状结构，该波状结构呈凹凸起伏状，在图7所示视角下，波状结构的顶部为波峰、底部为波谷，在缺口401处，第一环状支撑骨架30的波状结构处的至少一个波谷悬空设置，悬空设置是指，至少一个波谷没有连接连接骨架40。在另一个实施例中，继续参阅图7，第二环状支撑骨架50朝向或连接连接骨架40的一侧呈波状结构，该波形为凹凸起伏状，在图7所示视角下，波状结构的顶部为波峰、底部为波谷，在缺口401处，第二环状支撑骨架50的波状结构处的至少一个波峰悬空设置，悬空设置是指，至少一个波峰没有连接连接骨架40。
如图13所示，第一环状支撑骨架30朝向或连接连接骨架40a的一侧呈波状结构，该波状结构呈凹凸起伏状，在图13所示视角下，波状结构的顶部为波峰、底部为波谷，在缺口401处，第一环状支撑骨架30的波状结构处的至少一个波谷悬空设置，悬空设置是指，至少一个波谷没有连接连接骨架40a。在另一个实施例中，继续参阅图13，第二环状支撑骨架50朝向或连接连接骨架40a的一侧呈波状结构，该波形为凹凸起伏状，在图13所示视角下，波状结构的顶部为波峰、底部为波谷，在缺口401处，第二环状支撑骨架50的波状结构处的至少一个波峰悬空设置，悬空设置是指，至少一个波峰没有连接连接骨架40a。
本实施例中，第一环状支撑骨架30由三个第二波形支撑杆33沿第一环状支撑骨架30的轴向连接。本实施例中，每一第二波形支撑杆33由镍钛合金激光雕刻制成，第二波形支撑杆33的正弦波数量为9个。在其他实施例中，所述第二波形支撑杆33的数量和所述正弦波数量可以是其他数量。
如图8所示，连接骨架40设有与第一内腔35连通的第二内腔47，每相邻的两个第一连接杆45与第一波形支撑杆43及对应的第二波形支撑杆33围成网格孔48；网格孔48的孔径大于第一环状支撑骨架30的网格孔37的孔径。本实施例中，连接骨架40具有渐变段470，在由渐变段470的两侧至渐变段470中部的方向上，第二内腔47(即渐变段470)的内径逐渐增大，渐变段470可以理解为对应连接骨架40中的凸出部41；缺口401设于连接骨架40的渐变段470，且缺口401与第二内腔47连通。
如图7所示，第二环状支撑骨架50包括多个正弦波形的第三波形支撑杆53，多个第三波形支撑杆53沿第二环状支撑骨架50的轴向顺序排列；每一第三波形支撑杆53包括多个第三波峰532、多个第三波谷534、以及连接相邻两个第三波峰532和第三波谷534之间的第三波杆530，相邻的第一波谷434与第三波峰532通过第二连接杆46连接；即第一波形支撑杆43的每一第一波谷434与邻近第一波形支撑杆43的第三波形支撑杆53相邻的第三波峰532通过第二连接杆46连接。每一第三波形支撑杆53沿第二环状支撑骨架50的周向设置一圈，多个第三波形支撑杆53构成环状网格结构，每相邻的两个第三波形支撑杆53构成若干网格孔57，第二环状支撑骨架50的每一网格孔57的孔径小于网格孔48的孔径。
本实施例中，第二环状支撑骨架50由三个第三波形支撑杆53沿第二环状支撑骨架50的轴向连接。本实施例中，每一第三波形支撑杆53由镍钛合金激光雕刻制成，第三波形支撑杆53的正弦波数量为9个。在其他实施例中，所述第三波形支撑杆53和所述正弦波数量可以是其他数量。
第二环状支撑骨架50具有第三内腔55，即多个第三波形支撑杆53围成沿轴向延伸的第三内腔55，每相邻的两个第三波形支撑杆53构成若干网格孔57。每相邻的两个第二连接杆46与第一波形支撑杆43及对应的第三波形支撑杆53也围成网格孔48。第三内腔55与第二内腔47连通，网格孔48的孔径大于第二环状支撑骨架50的网格孔57的孔径。
本实施例中，渐变段470靠近第一环状支撑骨架30一端的内径等于第一内腔35的内径，或者渐变段470靠近第二环状支撑骨架50一端的内径等于第三内腔55的内径。第一波杆430的中部外凸使第一波形支撑杆43围合形成渐变段470的至少部分。在其他实施例中，第一内腔35的内径与第三内腔55的内径相等。此时，渐变段470相对两侧的内径值与第一内腔35的内径值和第二内腔55的内径值相等。
可选地，在由连接骨架40的两端至中部(即参考平面α)的方向上，第一连接杆45逐渐向外倾斜以连接于对应的第一波峰432，第二连接杆46逐渐向外倾斜以连接于对应的第一波谷434；第一连接杆45、第一波形支撑杆43、第二连接杆46围合形成渐变段470。若第一连接杆45包括所述第一竖直段452和第一弯曲段454，第二连接杆46包括第二竖直段462和第二弯曲段464，则此时第一连接杆45的部分(即第一弯曲段454)、第二波杆46的部分(即第二弯曲段464)、第一波形支撑杆43围合形成渐变段470。
如图8所示，凸出部41的最大外径D1大于第一环状支撑骨架30的外径D2和第二环状支撑骨架50的外径D3。本实施例中，第一环状支撑骨架30的外径D2等于第二环状支撑骨架50的外径D3；外径D2大小范围为5毫米-30毫米之间，最大外径D1比第一环状支撑骨架30的外径D2突出1.5毫米-2.5毫米。在其他实施例中，第一环状支撑骨架30的外径D2与第二环状支撑骨架50的外径D3可以不相 等。连接骨架40的轴向长度L1与第一环状支撑骨架30的轴向长度L2及第二环状支撑骨架50的轴向长度L3可以相同，也可以不同；本实施例中，连接骨架40的轴向长度L1、第一环状支撑骨架30的轴向长度L2，以及第二环状支撑骨架50的轴向长度L3相等，均为10毫米。
可选地，第一环状支撑骨架30、连接骨架40、第二环状支撑骨架50可为镍钛合金激光雕刻型的一体式支架。本实施例中，介入静脉瓣支架20的第一波杆430、第二波杆330、第三波杆530、第一连接杆45及第二连接杆46的宽为0.3毫米，杆厚0.35毫米；介入静脉瓣支架20的轴向总长在30毫米左右。
在其他实施例中，第一环状支撑骨架30、连接骨架40、第二环状支撑骨架50可以分别由不同的镍钛合金激光雕刻后固定连接于一体。
在自然状态下，第一环状支撑骨架30的轴向、连接骨架40的轴向和第二环状支撑骨架50的轴向两两相互平行。优选地，在自然状态下，第一环状支撑骨架30的轴心线与第二环状支撑骨架50的轴心线重合。需要说明的是，所谓自然状态，即介入静脉瓣支架20处于径向不受外力的释放状态。
在其他实施例中，在自然状态下，第一环状支撑骨架30的轴心线、连接骨架40的轴心线及第二环状支撑骨架50的轴心线重合。
如图7所示，在自然状态下，静脉瓣支架20的中部被参考平面α分割得到的两部分、以及静脉瓣支架20的内腔被参考平面α分割得到的两部分皆关于参考平面α对称，参考平面α的法线方向与第一环状支撑骨架30或第二环状支撑骨架50的轴向平行，且连接骨架40中用于形成连接骨架40最大内径的所有点的集合位于参考平面α内。
如图8所示，在自然状态下，静脉瓣支架20被参考平面β分割得到的两部分关于参考平面β对称，参考平面β与第一环状支撑骨架30或第二环状支撑骨架50的轴向平行，且参考平面β位于缺口401的中间。
如图3所示，缺口401在连接骨架40的周向上的最大开口角度C范围在90度-180度之间；凸出部41沿连接骨架40的周向从连接骨架40的一侧延伸至相对的另一侧，即凸出部41相对的两侧、第一环状支撑骨架30靠近连接骨架40没有连接第一连接杆45的部分，以及第二环状支撑骨架50靠近连接骨架40没有连接第二连接杆46的部分围成缺口401。
在其他实施例中，支撑体与连接骨架40通过编织丝制成，即第一环状支撑骨架30、连接骨架40及第二环状支撑骨架50通过编织丝制成。具体地，介入静脉瓣支架20通过一条超弹性镍钛丝编织而成，所述超弹性镍钛合金丝可选择的丝径(即直径)范围为0.1mm～0.6mm。连接骨架40的中部向外凸设形成凸出部，凸出部的内侧形成窦区；具体地，所述窦区通过插入连接骨架40内的模具定型后热处理后获得。由此具备的凸出部为环状的一整圈，整圈的凸出部会使得介入静脉瓣支架20两端锚定力下降，故可以通过切割整圈的凸出部的一部分而形成缺口，以此来提升介入静脉瓣支架20两端的锚定力。
在其他实施例中，第一环状支撑骨架30和第二环状支撑骨架50的横断面形状为椭圆形或梭形等。需要说明的是，为清楚定义横断面，横断面的法线方向与第一环状支撑骨架30的轴向和第二环状支撑骨架50的轴向平行。
请一并参阅图3-图4及图9-图10，瓣体72包括贴合于第一波形支撑杆43内表面的第一瓣片721、贴合于多个第一连接杆45内侧面的第二瓣片723，以及贴合地多个第二连接杆46内侧面的第三瓣片725。第一瓣片721、第二瓣片723及第三瓣片725可以是一体成型结构，瓣体72通过缝合、粘接或热压连接 于连接骨架40的内侧，使瓣体72相对的两端边缘分别连接于第一环状支撑骨架30与连接骨架40的相交处及第二环状支撑骨架50与连接骨架40的相交处。具体地，第二瓣片723远离第一瓣片721的边缘连接于第一环状支撑骨架30与连接骨架40的相交处，第三瓣片725远离第一瓣片721的边缘连接于第二环状支撑骨架50与连接骨架40的相交处。瓣体72相对的两侧延伸至连接骨架40相对的两侧，即瓣体72相对的两侧缘覆盖至缺口401相对的两边缘。瓣体72上固定有第一波形支撑杆43能增加支撑强度，防止连接骨架40因受到静脉血管的压迫而变形，防止瓣叶74失去单向阀的功能。
在其他实施例中，第一瓣片721、第二瓣片723及第三瓣片725可以是分体结构，第一瓣片721、第二瓣片723及第三瓣片725分别通过缝合、粘接或热压连接于第一波形支撑杆43、第一连接杆45及第二连接杆46，且使第一瓣片721、第二瓣片723及第三瓣片725于一个整体。
如图4及图10所示，瓣叶74通过缝合、粘接或热压连接于瓣体72的内侧面(即背离连接骨架40的侧面)，以构建血液在通过静脉瓣假体100时的单向通路，即瓣叶74的作用相当于单向阀。瓣叶74与瓣体72围成第一区域75和第二区域76，第一区域75对应窦区403的一部分，第二区域76对应窦区403的另一部分，第一区域75和第二区域76位于瓣叶74相对的两侧，瓣叶74罩设于第一区域75。第一区域75和第二区域76中的一者与第一环状支撑骨架30的第一内腔35连通。一实施例中，第一区域75为瓣叶74拱起后与第一环状支撑骨架30的第一内腔35连通的区域，第二区域76为瓣叶74拱起后与第二环状支撑骨架50的第三内腔55连通的区域。
在其他实施例中，瓣叶74与瓣体72也可以一体成型制成。
本实施例中，瓣膜组件70还包括设置于支撑体的周壁的覆膜，覆膜可设置于支撑体的内表面或者外表面，每一覆膜连接于瓣体72。具体地，所述覆膜包括设置于第一环状支撑骨架30的周壁的第一覆膜77及设置于第二环状支撑骨架50的第二覆膜78，第一覆膜77通过缝合、粘接或热压于第一环状支撑骨架30，且第一覆膜77靠近连接骨架40的一侧连接于瓣体72；第二覆膜78通过缝合、粘接或热压于第二环支撑骨架50，且第二覆膜78靠近连接骨架40的一侧连接于瓣体72。由于第一覆膜77上固定有第一环状支撑骨架30，第二覆膜78上固定有第二环状支撑骨架50，由于第一环状支撑骨架30及第二环状支撑骨架50采用超弹性的镍钛合金制成，因此，当介入静脉瓣支架20锚定于静脉血管300的内壁时，第一环状支撑骨架30及第二环状支撑骨架50分别弹性地抵顶静脉血管300的内壁，以增加了第一环状支撑骨架30及第二环状支撑骨架50的支撑强度，从而增强了第一环状支撑骨架30及第二环状支撑骨架50植入静脉血管后的锚定力。
在其他实施例中，第一覆膜77、瓣体72和第二覆膜78一体成型制成；或者瓣叶74、第一覆膜77、瓣体72和第二覆膜78一体成型制成。
瓣叶74、第一覆膜77、瓣体72和第二覆膜78均采用可由聚脂、聚四氟乙烯、聚氨脂，医用硅胶，涤纶，生物瓣膜、心包或其他可植入医用材料制成。。
如图1及图2所示，静脉瓣假体100通过输送装置植入于静脉血管300的内腔301的适当位置，第一环状支撑骨架30和第二环状支撑骨架50锚定于静脉血管300的内壁，连接骨架40抵顶静脉血管300的内壁而外凸，缺口401能减少连接骨架40的凸出部41对静脉血管300的过度扩张，且有利于第一环状支撑骨架30和第二环状支撑骨架50对静脉血管300更好的锚定，从而使静脉瓣假体100植入静脉血管300后不易发生移位。由于连接骨架40的网格孔48大于第一环状支撑骨架30的网格孔37及第二环 状支撑骨架50的网格孔57，且连接骨架40周向设有缺口401，因此，使得静脉瓣假体100整体具有一定的柔顺性，静脉瓣假体100在连接骨架40处容易弯折，静脉瓣假体100能更容易通过迂回复杂的血管，降低手术风险。如图7所示，连接骨架40的网格孔48指第一波形支撑杆43相邻的两个第一波杆430、与两个所述第一波杆430相连接的两个第一连接杆45，以及连接于所述两个第一连接杆45远离第一波形支撑杆43端部的两个第二波杆330围成的空间；第一环状支撑骨架30的网格孔37指相邻的两个第二波形支撑杆33中，其中一第二波形支撑杆33相邻的两个第二波杆330与另一第二波形支撑杆33相应的两个第二波杆330相连接后围成的闭合的空间；第二环状支撑骨架50的网格孔57指相邻的两个第三波形支撑杆53中，其中一第三波形支撑杆53相邻的两个第三波杆530与另一第三波形支撑杆53相应的两个第三波杆530相连接后围成的闭合的空间。网格孔48的开孔面积大于网格孔37的开孔面积及网格孔57的开孔面积。静脉血管300的内腔301中的血液顺流为自近端向远端，即自第二环状支撑骨架50的第三内腔55向第一环状支撑骨架30的第一内腔35，顺流的血液冲击瓣叶74向远离缺口401的一侧移动，瓣叶74与静脉血管300的内壁分离，以开通静脉瓣假体100的单向通路(如图1所示)。当瓣叶74被静脉血管300内血液回流的冲击而拱起后(如图2所示)，瓣叶74被血液回流的冲击向缺口401移动并与缺口401周围的静脉血管300内壁抵接，从而使瓣叶74关闭静脉血管300的内腔以避免血液返流；同时在第一区域75内形成涡流的区域，有效防止局部血栓形成。当静脉血管300内的血液再次顺流时，瓣叶74被顺流的血液抵推而向远离缺口401的一侧移动，参考图4，且瓣叶74挤压出第一区域75内的血液，使第一区域75内的血液流向第一内腔35；因此，基于第二区域76的存在，可以使得回流消失时，快速开通顺流的单向通路，增加顺流的血液流量。
在其他实施例中，静脉瓣假体100设有显影结构，具体地，第一环状支撑骨架30、连接骨架40及第二环状支撑骨架50三者之一设有显影结构，或者第一环状支撑骨架30、连接骨架40及第二环状支撑骨架50三者之二设有显影结构，或者第一环状支撑骨架30、连接骨架40及第二环状支撑骨架50分别设有显影结构。所述显影结构为连续或间断缠绕于静脉瓣假体100上的显影丝或显影点，或者介入静脉瓣支架20为掺有显影材料的合金所制成，例如所述镍钛合金金属丝由含钽的镍钛合金金属丝。
优选地，第一波形支撑杆43、邻近连接骨架40的第二波形支撑杆33及邻近连接骨架40的第三波形支撑杆三者之一围设至少一圈的显影丝或显影点。在手术过程中通过影像设备能清楚地观察出环状的显影结构的位置，方便快捷的在静脉血管300的内腔301内插入静脉瓣假体100。所述显影件材料包括但不限于金、铂、铂-钨、钯、铂-铱、铑、钽，或这些金属的合金或复合物。
在其他实施例中，第一覆膜77和/或第二覆膜78设有至少一圈的显影丝或显影点，所述显影丝或显影点通过缝合、热压或贴设的方式固定在第一覆膜77和/或第二覆膜78上。
请参阅图11，本申请第二实施例提供的静脉瓣假体100a的结构与第一实施例的结构相似，不同之处在于：静脉瓣假体100a是在第一实施例的静脉瓣假体100的基础上省略第一覆膜77及第二覆膜78。具体地，瓣膜组件70仅包括设置于连接骨架40内侧的瓣体72及连接于瓣体72内侧面的瓣叶74。静脉瓣假体100a省略第一覆膜77及第二覆膜78能节省制作成本。
请参阅图12及图13，本申请第三实施例提供的静脉瓣假体的结构与第一实施例的结构相似，不同之处在于：第三实施例中的介入静脉瓣支架20a的连接骨架40a的结构与第一实施例中的介入静脉瓣支架20的连接骨架40的结构不同：具体地，连接骨架40a包括若干支撑杆435，若干支撑杆435沿第一 环状支撑骨架30或第二支撑骨架50的轴向延伸并沿第一环状支撑骨架30或第二支撑骨架50的周向间隔排列，在第一环状支撑骨架30或第二支撑骨架50的周向上，相邻两个支撑杆435之间的间隔区域形成缺口401。其中，间隔距离最大的相邻两个支撑杆435之间的间隔区域形成的缺口401可供瓣叶74穿过以与静脉血管壁抵接，至少一个支撑杆435的中部向外弯曲形成凸出部41。
本实施例中，每一支撑杆435包括中部弯折段436、设于中部弯折段436近端的近端竖直段437，以及设于中部弯折段436远端的远端竖直段438，近端竖直段437远离中部弯折段436的一端连接于第一环状支撑骨架30，远端竖直段438远离中部弯折段436的一端连接于第二环状支撑骨架50。近端竖直段437沿第一环状支撑骨架30的轴向延伸，远端竖直段438沿第二环状支撑骨架50的轴向延伸，中部弯折段436的中部向外弯折，若干中部弯折段436形成凸出部41，凸出部41的内侧形成窦区403，瓣膜组件70设置于窦区403内。
若干支撑杆435的近端竖直段437分别连接于邻近的第二波形支撑杆33的第二波谷334，远端竖直段438分别连接于邻近的第三波形支撑杆53的第三波峰532；相邻的第二波形支撑杆33的第二波谷334与第三波形支撑杆53的第三波峰532之间未被支撑杆435连接的区域即形成缺口401。
本实施例中，支撑杆435的数目为六个，其在介入静脉瓣支架20a的周向270度范围内间隔排布。在排布支撑杆435的区域中，相邻两个支撑杆435之间的周向间隔角度为45度，此时，介入静脉瓣支架20a未排布支撑杆435的90度区间形成可供瓣叶74穿设的缺口401，即缺口401的开口周向角度为90度。
请参阅图14及图15，本申请第四实施例提供的静脉瓣假体100b的结构与第一实施例的静脉瓣假体100结构相似，不同之处在于：第四实施例中的静脉瓣假体100b是在第一实施例的静脉瓣假体100的基础上省略了第二环状支撑骨架50及第二覆膜78，即介入静脉瓣支架仅包括第一环状支撑骨架30及连接于第一环状支撑骨架30端部的连接骨架40；瓣膜组件70仅包括瓣体72、瓣叶74及第一覆膜77，瓣体72缝合、粘接或热压于连接骨架40，瓣叶74缝合、粘接或热压于瓣体72，第一覆膜77缝合、粘接或热压于第一环状支撑骨架30，瓣体72连接于第一覆膜77。静脉瓣假体100b省略第二环状支撑骨架50及第二覆膜78节省了制作成本。需要理解，此实施例中也可以省略掉第一覆膜77。
需要说明的是，在不偏离本申请申请原理的情况下，各个实施方式中的具体技术方案可以相互适用。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (20)

  1. 一种介入静脉瓣支架，能够径向压缩和扩张，其特征在于，包括：
    支撑体，包括第一环状支撑骨架；以及
    连接骨架，所述连接骨架连接于所述第一环状支撑骨架的端部，所述连接骨架沿所述第一环状支撑骨架的周向设置并在所述连接骨架的周向断开形成缺口，所述连接骨架的至少部分外凸形成凸出部，所述凸出部的内侧形成窦区。
  2. 根据权利要求1所述的介入静脉瓣支架，其特征在于，所述第一环状支撑骨架朝向或连接所述连接骨架的一侧呈波状结构，在所述缺口处，所述波状结构的至少一个波谷悬空设置。
  3. 根据权利要求1所述的介入静脉瓣支架，其特征在于，所述连接骨架包括第一波形支撑杆，所述第一波形支撑杆沿所述第一环状支撑骨架的周向延伸，所述第一波形支撑杆包括首尾相连的多个第一波杆，至少部分所述第一波杆朝外弯曲形成所述凸出部的至少一部分。
  4. 根据权利要求3所述的介入静脉瓣支架，其特征在于，所述第一波形支撑杆具有靠近所述第一环状支撑骨架的第一波峰和远离所述第一环状支撑骨架的第一波谷；所述连接骨架包括至少一个第一连接杆，所述第一连接杆连接所述第一波峰和所述第一环状支撑骨架。
  5. 根据权利要求3所述的介入静脉瓣支架，其特征在于，所述连接骨架还包括至少一个第二连接杆，所述第二连接杆连接所述第一波谷。
  6. 根据权利要求5所述的介入静脉瓣支架，其特征在于，在由所述第二连接杆远离所述第一波形支撑杆的一端至靠近所述第一波形支撑杆的一端的方向上，所述第二连接杆向外倾斜或弯曲，以连接于对应的所述第一波谷，所述第二连接杆形成为所述凸出部的一部分。
  7. 根据权利要求4所述的介入静脉瓣支架，其特征在于，每一所述第一波杆的中部外凸以形成所述凸出部的一部分；在由所述第一连接杆靠近所述第一环状支撑骨架的一端至远离所述第一环状支撑骨架的一端的方向上，每一所述第一连接杆向外倾斜或弯曲，以连接于对应的所述第一波峰，所述第一连接杆形成为所述凸出部的一部分。
  8. 根据权利要求4所述的介入静脉瓣支架，其特征在于，每一所述第一波杆的中部外凸以形成所述凸出部的一部分；所述第一连接杆包括第一竖直段和第一弯曲段，所述第一竖直段沿所述第一环状支撑骨架的轴向延伸，在由所述第一连接杆靠近所述第一环状支撑骨架的一端至远离所述第一环状支撑骨架的一端的方向上，所述第一弯曲段逐渐向外弯曲，以连接于对应的所述第一波峰，所述第一弯曲段形成所述凸出部的一部分。
  9. 根据权利要求4所述的介入静脉瓣支架，其特征在于，所述第一环状支撑骨架包括多个第二波形支撑杆，多个所述第二波形支撑杆沿所述第一环状支撑骨架的轴向顺序排列；每个所述第二波形支撑杆包括多个第二波峰、多个第二波谷、以及连接相邻两个所述第二波峰和所述第二波谷之间的第二波杆，所述第一连接杆的两端分别连接所述第一波峰与所述第二波谷。
  10. 根据权利要求9所述的介入静脉瓣支架，其特征在于，每相邻的两个所述第一连接杆与所述第一波形支撑杆及对应的所述第二波形支撑杆围成第一网格孔，每相邻的两个所述第二波形支撑杆构成若干第二网格孔，所述第一网格孔的孔径值大于所述第二网格孔的孔径值。
  11. 根据权利要求1或2所述的介入静脉瓣支架，其特征在于，所述连接骨架包括若干支撑杆，若干所述支撑杆沿所述第一环状支撑骨架的轴向延伸并沿所述第一环状支撑骨架的周向间隔排列，在所述第一环状支撑骨架的周向上，任意相邻两个所述支撑杆之间的间隔区域形成所述缺口，至少一个所述支撑杆向外弯曲形成所述凸出部。
  12. 据权利要求1至11中任意一项所述的介入静脉瓣支架，其特征在于，所支撑体还包括第二环状支撑骨架，所述连接骨架设置于所述第一环状支撑骨架与所述第二环状支撑骨架之间，所述连接骨架沿所述第二环状支撑骨架的周向设置。
  13. 根据权利要求12所述的介入静脉瓣支架，其特征在于，所述凸出部的外径大于所述第一环状支撑骨架的外径及所述第二环状支撑骨架的外径。
  14. 根据权利要求12所述的介入静脉瓣支架，其特征在于，自然状态下，所述第一环状支撑骨架的轴向平行所述第二环状支撑骨架的轴向。
  15. 根据权利要求12所述的介入静脉瓣支架，其特征在于，在自然状态下，所述静脉瓣支架的内腔被参考平面分割的两部分关于所述参考平面对称，所述参考平面的法线方向与所述第一环状支撑骨架的轴向平行，且形成所述连接骨架的最大内径的所有点的集合位于所述参考平面内。
  16. 根据权利要求1所述的介入静脉瓣支架，其特征在于，所述缺口在所述连接骨架的周向上的最大开口角度范围在90度-180度之间。
  17. 根据权利要求1所述的介入静脉瓣支架，其特征在于，所述凸出部沿所述连接骨架的周向从所述连接骨架的一侧延伸至相对的另一侧。
  18. 一种静脉瓣假体，用于植入静脉血管，其特征在于，所述静脉瓣假体包括如权利要求1-16任意一项所述的介入静脉瓣支架以及瓣膜组件，所述瓣膜组件包括连接于所述连接骨架内侧的瓣叶，所述瓣叶罩设于所述窦区的至少部分并用于构建所述静脉血管内的单向通路。
  19. 根据权利要求18所述的静脉瓣假体，其特征在于，所述瓣膜组件还包括贴合于所述连接骨架内表面的瓣体，所述瓣叶与所述瓣体围成第一区域和第二区域，所述第一区域对应所述窦区的一部分，所述第二区域对应所述窦区的另一部分，所述第一区域和所述第二区域位于所述瓣叶相对的两侧，所述第一区域和所述第二区域中的一者与所述第一环状支撑骨架的内腔连通，所述瓣叶罩设于所述第一区域。
  20. 根据权利要求19所述的静脉瓣假体，其特征在于，所述瓣膜组件还包括设置于所述支撑体的周壁的覆膜，所述覆膜连接于所述瓣体。
PCT/CN2021/116157 2020-09-04 2021-09-02 介入静脉瓣支架及静脉瓣假体 WO2022048585A1 (zh)

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