WO2022048585A1 - Endoprothèse de valvule veineuse d'intervention et prothèse de valvule veineuse - Google Patents

Endoprothèse de valvule veineuse d'intervention et prothèse de valvule veineuse 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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WIPO (PCT)
Prior art keywords
wave
frame
interventional
venous valve
support frame
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PCT/CN2021/116157
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English (en)
Chinese (zh)
Inventor
王永胜
郭伟
李建民
Original Assignee
杭州诺谊医疗科技有限公司
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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/fr

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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.

Abstract

La présente invention concerne une endoprothèse de valvule veineuse d'intervention (20, 20a), comprenant un corps de support et un échafaudage de liaison (40, 40a), le corps de support comprenant un premier échafaudage de support annulaire (30) ; l'échafaudage de liaison (40, 40a) étant relié à une extrémité du premier échafaudage de support annulaire (30) ; l'échafaudage de liaison (40, 40a) étant disposé dans la direction circonférentielle du premier échafaudage de support annulaire (30) et étant rompu dans la direction circonférentielle de l'échafaudage de liaison (40, 40a) pour former une encoche (401) ; au moins une partie de l'échafaudage de liaison (40, 40a) faisant saillie vers l'extérieur pour former une partie en saillie (41) ; et une région de sinus (403) étant formée sur un côté interne de la partie en saillie (41). Avec l'encoche (401), l'endoprothèse de valvule veineuse d'intervention (20, 20a) présente une bonne flexibilité, de telle sorte que l'endoprothèse de valvule veineuse d'intervention (20, 20a) peut passer dans un vaisseau sanguin tortueux et complexe plus facilement pour réduire le risque opérationnel ; et avec des feuillets (74), le sang de reflux forme un écoulement tourbillonnaire dans la zone de la région de sinus (403) recouverte par les feuillets (74) de façon à empêcher un reflux de sang, ce qui permet d'obtenir un effet clinique satisfaisant d'une prothèse de valvule veineuse (100, 100a, 100b). L'invention concerne en outre une prothèse de valvule veineuse (100, 100a, 100b) pourvue de l'endoprothèse de valvule veineuse d'intervention.
PCT/CN2021/116157 2020-09-04 2021-09-02 Endoprothèse de valvule veineuse d'intervention et prothèse de valvule veineuse WO2022048585A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202010925749.2 2020-09-04
CN202010925749.2A CN114145884A (zh) 2020-09-04 2020-09-04 介入静脉瓣支架及静脉瓣假体
CN202021921538.3 2020-09-04
CN202021921538.3U CN212630964U (zh) 2020-09-04 2020-09-04 介入静脉瓣支架及静脉瓣假体

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US20070100435A1 (en) * 2003-04-24 2007-05-03 Cook Incorporated Artificial prostheses with preferred geometries
US20080288055A1 (en) * 2007-05-17 2008-11-20 Cook Incorporated Monocuspid Prosthetic Valve Having a Partial Sinus
US20090287296A1 (en) * 2008-05-16 2009-11-19 Sorin Biomedica Cardio S.R.L. Atraumatic prosthetic heart valve prosthesis
US20120101567A1 (en) * 2009-06-29 2012-04-26 Josef Jansen Percutaneously implantable flap stent, device for applying the same and method for producing the flap stent
US20170020672A1 (en) * 2005-09-21 2017-01-26 Boston Scientific Scimed, Inc. Venous valve, system, and method with sinus pocket
CN108135689A (zh) * 2015-10-13 2018-06-08 静脉医学有限责任公司 可植入瓣膜及方法
CN109963530A (zh) * 2016-11-15 2019-07-02 汉考克贾菲实验室公司 可植入的静脉框架
CN110353858A (zh) * 2018-04-09 2019-10-22 倍芮医疗器械（上海）有限公司 用于负载瓣膜的支架以及静脉瓣置换装置
CN212630964U (zh) * 2020-09-04 2021-03-02 杭州诺谊医疗科技有限公司 介入静脉瓣支架及静脉瓣假体

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Publication number Priority date Publication date Assignee Title
US6299637B1 (en) * 1999-08-20 2001-10-09 Samuel M. Shaolian Transluminally implantable venous valve
US20070100435A1 (en) * 2003-04-24 2007-05-03 Cook Incorporated Artificial prostheses with preferred geometries
US20170020672A1 (en) * 2005-09-21 2017-01-26 Boston Scientific Scimed, Inc. Venous valve, system, and method with sinus pocket
US20080288055A1 (en) * 2007-05-17 2008-11-20 Cook Incorporated Monocuspid Prosthetic Valve Having a Partial Sinus
US20090287296A1 (en) * 2008-05-16 2009-11-19 Sorin Biomedica Cardio S.R.L. Atraumatic prosthetic heart valve prosthesis
US20120101567A1 (en) * 2009-06-29 2012-04-26 Josef Jansen Percutaneously implantable flap stent, device for applying the same and method for producing the flap stent
CN108135689A (zh) * 2015-10-13 2018-06-08 静脉医学有限责任公司 可植入瓣膜及方法
CN109963530A (zh) * 2016-11-15 2019-07-02 汉考克贾菲实验室公司 可植入的静脉框架
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117547382A (zh) * 2023-05-24 2024-02-13 杭州启明医疗器械股份有限公司 人工植入物的介入系统

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