CN109124829A - It is a kind of through conduit aortic valve and preparation method thereof - Google Patents

It is a kind of through conduit aortic valve and preparation method thereof Download PDF

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Publication number
CN109124829A
CN109124829A CN201810694112.XA CN201810694112A CN109124829A CN 109124829 A CN109124829 A CN 109124829A CN 201810694112 A CN201810694112 A CN 201810694112A CN 109124829 A CN109124829 A CN 109124829A
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CN
China
Prior art keywords
valve
aortic valve
skirt
area
conduit
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201810694112.XA
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Chinese (zh)
Inventor
钟生平
孟春旺
李珂
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd
Original Assignee
JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd filed Critical JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd
Priority to CN201810694112.XA priority Critical patent/CN109124829A/en
Publication of CN109124829A publication Critical patent/CN109124829A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415Manufacturing methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents

Abstract

The present invention provides a kind of through conduit aortic valve and preparation method thereof, this includes the netted valve frame of expandable through conduit aortic valve, valve skirt and multiple leaflets, wherein, the valve skirt is disposed around the inside of the valve frame, the leaflet is located in the inner cavity of the valve frame, wherein, the valve skirt is divided into first area and second area, the first area is towards the inflow end of the aortic valve, outflow end of the second area towards the aortic valve, and the mesh that can will be connected to inside and outside the valve frame is opened up on the second area, it is provided by the invention that coronary artery mouth is easily blocked after conduit aortic valve solves the problems, such as aortic valve implantation in the prior art and aortic valve is applicable in patient and is limited.

Description

It is a kind of through conduit aortic valve and preparation method thereof
Technical field
The present invention relates to the field of medical instrument technology more particularly to a kind of through conduit aortic valve and preparation method thereof.
Background technique
Through conduit aortic valve replacement (Transcatheter Aortic Valve Replacement, referred to as: TAVR) it is a kind of minimally invasive valve replacement surgery, refers to and assembled aorta petal is placed in aortic root through conduit, substitute original Aorta petal functionally completes aortic valve replacement, the specific implantation process of TAVR are as follows: artificial valve compression is first entered one Set recycles transportation system to pass through artery (such as femoral artery, subclavian artery activity abdominal aorta through in catheter delivery system Deng) or the apex of the heart valve be transported to aortic root and discharge, be fixed in annulus, by artificial valve to human aorta Valve is replaced, and TAVR has become the main of the surgical operation that can not be resistant to or the high-risk aortic stenosis in patients of surgical operation Treatment means.
Currently, patent (CN106890035A) discloses a kind of through conduit implanted aorta petal film device, specific open (ginseng See such as Fig. 1 and Fig. 2): include: valve bracket through conduit implanted aorta petal film device 100, is fixed in the valve bracket Between sections inner side leaflet 106, be fixed on the valve bracket and flow into the inner skirt 103 connecting on the inside of end and with the leaflet, The outer skirt 104 being fixed on the outside of valve bracket inflow end middle and upper part, inner skirt 103 and outer skirt 104 are along valve bracket Surrounding forms a circle, and is fixed on valve bracket with suture or the modes such as pressing or bonding;Leaflet 106 is 3 valve structures Composition is sewn in the middle section of valve bracket by suture, and fixes and suture with inner skirt 103.Valve bracket includes: the valve Membrane support flows into the lower bell-mouth structure of air 102 that multiple diamond structure compositions are presented in end;Institute is used in the lower horn structure end State three connection pawls 101 needed for valve bracket loads;The centre of the valve bracket by flow into end part on the outside of have upwards to Multiple location structures 105 of outer expansion;By the straight-bar connection structure 107 with holes of outflow end part among the valve bracket;Institute State the upper bell-mouth structure of air 108 that multiple big grid diamond structure compositions are presented in valve bracket outflow end, wherein through conduit implanted Aorta petal film device is implanted at aorta petal in situ as shown in Fig. 2, location structure 105 has positive location and adaptive master The characteristics of artery annulus 201 and natural leaflet 202, the big grid diamond structure of bell-mouth structure of air on the valve bracket outflow end It is uniformly distributed and guarantees the valve bracket in aorta ascendens 204, the outer skirt 104 is fitted in valve bracket and flows into loudspeaker under end The centre of mouth structure 102 and aortic valvular ring 201 is to reduce perivalvular leakage.
However, often there are certain requirements to the height of coronary artery mouth 203 (needs coronary artery when above-mentioned aorta petal film device is implanted into Open height is greater than 10mm), for patient of the coronary artery open height lower than 10mm, once the implantation of aorta petal film device is too deep easily There is the risk of coronary artery mouth blocking.
Summary of the invention
In order to solve the problems, such as at least one mentioned in background technique, the present invention provide it is a kind of through conduit aortic valve and Its production method reduces the risk that coronary artery mouth is blocked.
To achieve the goals above, in a first aspect, the present invention provide it is a kind of through conduit aortic valve, including including can diameter To flexible netted valve frame, valve skirt and multiple leaflets, wherein the valve skirt is disposed around the inside of the valve frame, the leaflet position In the inner cavity of the valve frame, in which:
The valve skirt is divided into first area and second area, inflow of the first area towards the aortic valve End, the second area is towards the outflow end of the aortic valve, and opening up on the second area can will be in the valve frame The mesh of outer connection.
It is provided in this embodiment through conduit aortic valve, by the way that the valve skirt is divided into first area and the secondth area Domain, the first area is towards the inflow end of the aortic valve, stream of the second area towards the aortic valve Outlet, and open up and the mesh being connected to inside and outside the valve frame can be planted when through conduit aortic valve in this way on the second area After entering, due to opening up mesh on the second area of valve skirt, accordingly even when being implanted into too deep and coronary artery mouth through conduit aortic valve It is highly lower, but can be flowed out by the mesh on valve skirt second area through the blood in conduit aortic valve inner cavity, into And enter coronary artery mouth, it ensure that the normal circulation of coronary artery mouth, avoid too deep through the implantation of conduit aortic valve and cause coronary artery Mouth is blocked risk the problem of increasing, while what is provided in the present embodiment can be adapted for coronary artery open height through conduit aortic valve Higher and lower patient, so that the application range through conduit aortic valve is wider, therefore, in the present embodiment, by valve Mesh is opened up on the second area of skirt reduces the blocked risk of coronary artery mouth, expands and applies model through conduit aortic valve It encloses, solves that coronary artery mouth after the implantation of aortic valve in the prior art is easily blocked and aortic valve is applicable in what patient was limited Problem.
In one embodiment of this invention, the bottom end of the leaflet is vertically lower than most bottom on the second area The mesh at end.
In one embodiment of this invention, between the lowermost end of the second area and the bottom of the aortic valve Distance is between 0~50mm.
In one embodiment of this invention, the total open area of all mesh accounts for described second on the second area The 30~50% of the region gross area.
In one embodiment of this invention, the shape of the mesh is one in round, polygon and irregular polygon Kind is a variety of.
In one embodiment of this invention, further includes: sealed skirt, the sealed skirt are disposed around outside the bottom end of the valve frame Side, the sealed skirt between the aortic valve and annulus for will be sealed.
In one embodiment of this invention, the Basolateral of the valve frame is equipped with the mark point that can develop, the mark Point is used to indicate the position of the mesh.
In one embodiment of this invention, the mark point is mark point made of platinumiridio or tantalum alloy.
In one embodiment of this invention, the valve frame is to pass through laser using Nitinol, stainless steel or cochrome Self-expansion type or balloon-expandable metallic support made of engraving, electrochemical polish and heat treatment.
In one embodiment of this invention, when the valve frame is self-expansion type metallic support, the top of the valve frame is equipped with Multiple auxiliary fixing devices, the auxiliary fixing device with transportation system for being connected.
In one embodiment of this invention, the quantity of the auxiliary fixing device is 2-6, and the auxiliary fixing device For round, semicircle, T-type or S type.
In one embodiment of this invention, the valve skirt, the sealed skirt and the leaflet are sewn on by sewing mode On the valve frame.
In one embodiment of this invention, the material of the valve skirt and the sealed skirt include it is following any one: poly- pair Ethylene terephthalate (PET), polytetrafluoroethylene (PTFE) (PTFE), bovine pericardium or Pigs Hearts are packed into;
The leaflet is packed into using ox or Pigs Hearts.
In one embodiment of this invention, the quantity of the leaflet is 2-4.
Second aspect, the present invention provide a kind of production method through conduit aortic valve, which comprises
Multiple leaflets are sewed in the inner cavity of valve frame;
On the inside of the valve frame sew valve skirt, and the valve skirt towards valve frame top one end through being cut by laser Or it is knitted to form mesh-structured, wherein the bottom end of the leaflet is lower than the mesh-structured lowermost end;
Sealed skirt is sewed in the Basolateral of the valve frame.
Production method provided in this embodiment through conduit aortic valve, it is obtained to be implanted into through conduit aortic valve Afterwards, due to opening up mesh on the second area of valve skirt, accordingly even when it is high to be implanted into too deep and coronary artery mouth through conduit aortic valve It spends lower, but can be flowed out by the mesh on valve skirt second area through the blood in conduit aortic valve inner cavity, in turn Into coronary artery mouth, the normal circulation of coronary artery mouth ensure that, avoid too deep through the implantation of conduit aortic valve and cause coronary artery mouth The risk that is blocked increase the problem of, while provided in the present embodiment through conduit aortic valve can be adapted for coronary artery open height compared with High and lower patient, so that the application range through conduit aortic valve is wider, it is therefore, provided in this embodiment through conduit master The production method of artery valve reduces the blocked risk of coronary artery mouth, expands the application range through conduit aortic valve, Solve the problems, such as that coronary artery mouth is easily blocked after aortic valve implantation in the prior art and applicable patient is limited.
Construction and its other purposes of the invention and beneficial effect will be in conjunction with the accompanying drawings to preferred embodiments Description and it is more obvious and easy to understand.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is this hair Bright some embodiments for those of ordinary skill in the art without any creative labor, can be with It obtains other drawings based on these drawings.
Fig. 1 is the structural schematic diagram of existing aortic valve;
Fig. 2 is the structural schematic diagram after existing aortic valve is implanted between human body annulus;
Fig. 3 is the structural schematic diagram through conduit aortic valve that the embodiment of the present invention one provides;
Fig. 4 is the structural schematic diagram through conduit aortic valve mesopetalum frame that the embodiment of the present invention one provides;
Fig. 5 is the deployed configuration schematic diagram through conduit aortic valve mesopetalum skirt that the embodiment of the present invention one provides;
Fig. 6 is that the enlarged structure through mesh in conduit aortic valve mesopetalum skirt that the embodiment of the present invention one provides is illustrated Figure;
Fig. 7 is the another enlarged structure through mesh in conduit aortic valve mesopetalum skirt that the embodiment of the present invention one provides Schematic diagram;
Fig. 8 is the structural schematic diagram provided by Embodiment 2 of the present invention through conduit aortic valve.
Description of symbols:
10-valve framves;11-auxiliary fixing devices;12-mark points;20-valve skirts;21-first areas;22-the second area Domain;221-mesh;30-sealed skirts;40-leaflets.
Specific embodiment
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is this hair Bright some embodiments for those of ordinary skill in the art without any creative labor, can be with It obtains other drawings based on these drawings.
It is described in detail to of the invention through conduit aortic valve below by specific embodiment:
Embodiment one
Fig. 3 is the structural schematic diagram through conduit aortic valve that the embodiment of the present invention one provides, and Fig. 4 is that the present invention is real The structural schematic diagram through conduit aortic valve mesopetalum frame of the offer of example one is applied, Fig. 5 is what the embodiment of the present invention one provided Deployed configuration schematic diagram through conduit aortic valve mesopetalum skirt, Fig. 6 be the embodiment of the present invention one provide through conduit actively The enlarged structure schematic diagram of mesh in arteries and veins valve mesopetalum skirt, Fig. 7 be the embodiment of the present invention one provide through conduit aorta petal The another enlarged structure schematic diagram of mesh in film mesopetalum skirt;
The present embodiment provides a kind of through conduit aortic valve, and referring to shown in Fig. 3-7, this is through conduit aortic valve packet It includes: netted valve frame 10, valve skirt 20 and the multiple leaflets 40 of expandable, wherein valve skirt 20 is disposed around the inside of valve frame 10, valve Leaf 40 is located in the inner cavity of valve frame 10.
Wherein, in the prior art, when coronary artery open height is lower than 10mm, once it is too deep through the implantation of conduit aortic valve, Valve skirt 20 increases the risk that coronary artery mouth blocks.
For this purpose, in the present embodiment, in order to reduce the risk of coronary artery mouth blocking, specifically, valve skirt 20 is divided into the firstth area Domain 21 and second area 22, first area 21 is towards the inflow end (i.e. bottom end) of aortic valve, and second area 22 is towards actively The lower section that the outflow end (i.e. top) of arteries and veins valve, i.e. first area 21 are located at second area 22, and opening up on second area 22 can The mesh 221 that will be connected to inside and outside valve frame 10 that is, in the present embodiment, opens up mesh 221, valve skirt 20 on the second area 22 of valve skirt 20 Second area 22 be 221 structure of mesh, the first area 21 of valve skirt 20 is hermetic unit, in this way when through conduit aortic valve After implantation, due to opening up mesh 221 on the second area 22 of valve skirt 20, accordingly even when it is too deep through the implantation of conduit aortic valve, But can be flowed out by the mesh 221 on 20 second area 22 of valve skirt through the blood in conduit aortic valve inner cavity, in turn Into coronary artery mouth, the normal circulation of coronary artery mouth ensure that, therefore, in the present embodiment, by the second area 22 of valve skirt 20 Opening up mesh 221 reduces the blocked risk of coronary artery mouth, simultaneously as in the prior art, coronary artery mouth is blocked in order to prevent, institute With through more demanding to the placement location of aortic valve in conduit aortic valve implantation process, and in the present embodiment, due to Blood can be flowed out by the mesh 221 of the second area 22 on valve skirt 20, and the placement location of such aortic valve can become Width, so that the operation difficulty through conduit aortic valve in implantation process reduces.
Wherein, in the present embodiment, it should be noted that when opening up mesh 221 on the second area 22 of valve skirt 20, need to guarantee It when leaflet 40 is closed, can not be flowed out from mesh 221 through the blood in conduit aortic valve inner cavity, i.e. leaflet 40 and mesh 221 Between positional relationship need to guarantee blood leaflet 40 be closed when can not flow out from mesh 221, only when leaflet 40 opening when, blood Opening outflow of the liquid Jing Guo leaflet 40, a portion blood enter coronary artery mouth by mesh 221, and another part blood enters liter In artery.
Wherein, in the present embodiment, it should be noted that the second area 22 of valve skirt 20 can extend up to valve frame 10 Top, the i.e. inside of valve frame 10 can all be covered by the second area 22 of valve skirt 20 and first area 21.
Wherein, in the present embodiment, the second area 22 of valve skirt 20 and the height of first area 21 are with specific reference to practical application It is set, as long as guaranteeing that the first area 21 of valve skirt 20 can play sealing function, second area 22 can guarantee through conduit The inside and outside of aortic valve can be connected to coronary artery mouth.
It is provided in this embodiment through conduit aortic valve, by the way that valve skirt 20 is divided into first area 21 and second area 22, first area 21 is towards the inflow end of aortic valve, outflow end of the second area 22 towards aortic valve, and the secondth area The mesh 221 that can will be connected to inside and outside valve frame 10 is opened up on domain 22, in this way after the implantation of conduit aortic valve, due to valve skirt 20 Second area 22 on open up mesh 221, accordingly even when through conduit aortic valve be implanted into too deep and coronary artery open height it is lower, But can be flowed out by the mesh 221 on 20 second area 22 of valve skirt through the blood in conduit aortic valve inner cavity, in turn Into coronary artery mouth, the normal circulation of coronary artery mouth ensure that, avoid too deep through the implantation of conduit aortic valve and cause coronary artery mouth The risk that is blocked increase the problem of, while provided in the present embodiment through conduit aortic valve can be adapted for coronary artery open height compared with High and lower patient, so that the application range through conduit aortic valve is wider, therefore, in the present embodiment, by valve skirt Mesh 221 is opened up on 20 second area 22 reduces the blocked risk of coronary artery mouth, expands through conduit aortic valve Application range, solves that coronary artery mouth after the implantation of aortic valve in the prior art is easily blocked and what applicable patient was limited asks Topic.
Further, on the basis of the above embodiments, in the present embodiment, in order to guarantee leaflet 40 be closed when, blood without Method is flowed out from mesh 221, specifically, the bottom end of leaflet 40 to be vertically lower than to the mesh of lowermost end on second area 22 221, the i.e. top that is respectively positioned on 40 bottom end of leaflet of mesh 221 on 20 second area 22 of valve skirt, this ensure that leaflet 40 is closed When, it can not be flowed out from mesh 221 through the blood in conduit aortic valve inner cavity, only when leaflet 40 is opened, blood passes through Opening a part of leaflet 40 is flowed out through mesh 221, and enters coronary artery mouth, and another part enters in ascending artery.
Wherein, in the present embodiment, the quantity of leaflet 40 can be multiple, such as can be with 2-4, preferably, leaflet 40 Quantity is 3, and three inner cavities of the control of leaflet 40 through conduit aortic valve are opened and closure.
Wherein, in the present embodiment, leaflet 40 is specifically packed into and is formed using using bovine pericardium or Pigs Hearts, meanwhile, leaflet 40 It is sewed in the inner cavity of valve frame 10 especially by sewing mode.
Further, on the basis of the above embodiments, in the present embodiment, the lowermost end and aorta petal of second area 22 The distance between bottom (i.e. the lowermost end of aortic valve) of film is between 0~50mm, preferably, the lowermost end of second area 22 The distance between bottom of aortic valve is 4-6mm, for example, the bottom of the lowermost end of second area 22 and aortic valve The distance between can be 4mm or 5mm, wherein when between the lowermost end of second area 22 and the bottom of aortic valve Distance can be 4mm 5mm when, at this time the height of the first area 21 of valve skirt 20 then can be less than or equal to 4mm or be less than etc. In 5mm.
Further, on the basis of the above embodiments, in the present embodiment, all mesh 221 is total on second area 22 Perforated area accounts for the 30~50% of 22 gross area of second area, i.e. hollow out rate on second area 22 is 30~50%, protects in this way Card coronary artery mouth after the implantation of conduit aortic valve can maintain normal blood circulation, avoid making since mesh 221 is very few The amount for flowing into coronary artery mouth at blood is less and influence coronary blood supply, specifically, on second area 22 all mesh 221 total aperture Area, which accounts for 22 gross area of second area, to be 40%, or 45%.
Further, on the basis of the above embodiments, in the present embodiment, the shape of mesh 221 be round, polygon and One or more of irregular polygon, as seen in figs. 5-6, the shape of mesh 221 are circle, or as shown in fig. 7, net The shape in hole 221 is triangle and quadrangle, wherein the shape of mesh 221 includes but is not limited to shape as shown in Figure 6 and Figure 7 Shape.
Further, on the basis of the above embodiments, in the present embodiment, side week leaks in order to prevent, further includes: sealed skirt 30, sealed skirt 30 is disposed around the Basolateral of valve frame 10, i.e., in the present embodiment, sealed skirt 30 is disposed around the outside of valve frame 10, such as Shown in Fig. 3, sealed skirt 30 is located at the bottom end of valve frame 10, and sealed skirt 30 is used to be sealed between aortic valve and annulus, Prevent side week from leaking, wherein in the present embodiment, it should be noted that when sealed skirt 30 is arranged, since sealed skirt 30 can play Sealing function, the first area 21 (i.e. hermetic unit) of valve skirt 20 can be omitted at this time, in this way can be in the entire side of valve skirt 20 Mesh 221 is opened up on face.
Wherein, in the present embodiment, for sealed skirt 30 when the outside of valve frame 10 is arranged, sealed skirt 30 is located at the bottom of valve frame 10 End could make mesh 221 be connected with coronary artery mouth in this way specifically, sealed skirt 30 is no more than the top of second area 22.
Wherein, in the present embodiment, the material of sealed skirt 30 can be polyethylene terephthalate (polyethylene Terephthalate, referred to as: PET), polytetrafluoroethylene (PTFE) (Poly tetra fluoroethylene, referred to as: PTFE), cattle heart Packet or Pigs Hearts packet, preferably Pigs Hearts packet.
Wherein, in the present embodiment, sealed skirt 30 is sewn on valve frame 10 especially by sewing mode.
Further, on the basis of the above embodiments, in the present embodiment, in order to convenient to mesh 221 in implantation Position is observed, specifically, as shown in figure 4, being equipped with the mark point 12 that can develop, identification point on the Basolateral of valve frame 10 It is used to indicate the position of mesh 221, when being implanted into this way, the location of mesh 221 can be judged according to mark point 12, from And facilitate the placement through conduit aortic valve.
Further, on the basis of the above embodiments, in the present embodiment, mark point 12 is specially that platinumiridio or tantalum close Mark point made of gold, preferably, using mark point 12 made of tantalum alloy.Wherein, in the present embodiment, mark point 12 is specifically logical It crosses on mosaic mode on valve frame 10, mark point 12 can be located at the node of valve frame 10, can also be located at the bracket of valve frame 10 On bar.
Further, on the basis of the above embodiments, in the present embodiment, as shown in figure 3, valve frame 10 is self-expansion type gold Belong to bracket, the diameter of the bottom end (i.e. inflow end) of valve frame 10 is less than the diameter on the top (i.e. outflow end) of valve frame 10, is implanted into this way When, the bottom end of valve frame 10 and annulus are in close contact, and are in close contact between the top and ascending artery of valve frame 10, and due to valve frame 10 Top end diameter is larger, so that the radial force between valve frame 10 and aorta is larger, fixed function of the valve frame 10 in annulus More preferably.
Wherein, in the present embodiment, valve frame 10 is specifically made of Nitinol, stainless steel or cochrome, when production, is led to Cross laser engraving, electrochemical polish and heat treatment be made can radial contraction and expansion netted valve frame, wherein in the present embodiment, The material of valve frame 10 is preferably Nitinol.
Further, on the basis of the above embodiments, in the present embodiment, when valve frame 10 is self-expansion type metallic support, The top of valve frame 10 is equipped with multiple auxiliary fixing devices 11, and auxiliary fixing device 11 with transportation system for being connected, in this way through leading Pipe aortic valve is taken in by auxiliary fixing device 11 into transportation system, can be carried out after being sterilized through conduit heart master Artery film displacement technique, wherein in the present embodiment, when valve frame 10 is self-expansion type metallic support, valve frame 10 is by conduit from swollen It is swollen discharged or the present embodiment in, using other Mechanical Drivens or release can also be driven by electricity.
Further, on the basis of the above embodiments, in the present embodiment, the quantity of auxiliary fixing device 11 is 2-6, The quantity of auxiliary fixing device 11 is preferably 3, wherein in the present embodiment, the shape of auxiliary fixing device 11 can for it is round, Semicircle, T-type or S type.
Embodiment two
Fig. 8 is the structural schematic diagram provided by Embodiment 2 of the present invention through conduit aortic valve.
The difference of the present embodiment and above-described embodiment are as follows: in the present embodiment, valve frame 10 is specially balloon-expandable metal branch Frame, valve frame 10 are specifically made up using Nitinol, stainless steel or cochrome of laser engraving, electrochemical polish and heat treatment Can radial contraction and expansion netted valve frame 10, i.e., in the present embodiment, the material of valve frame 10 can be Nitinol, stainless steel Or cochrome, when production, valve frame 10 is made using laser engraving, electrochemical polish and heat treatment process.
Wherein, in the present embodiment, equipment is held especially by pressure through conduit aortic valve and is compressed to balloon-expandable valve Conduit can be carried out after being sterilized through conduit heart aorta film displacement technique, wherein after the implantation of conduit aortic valve, Valve frame 10 is especially by balloon expandable release or other Mechanical Drivens or is driven by electricity release.
Embodiment three
The present embodiment provides a kind of above-mentioned production method through conduit aortic valve, specific production method includes as follows Step:
Step 1): multiple leaflets 40 are sewed in the inner cavity of valve frame 10;
Wherein, before step 1) further include: carry out electrochemical polish and heat treatment after valve frame 10 is carried out laser engraving After self-expansion type or balloon-expandable metallic support is made, and inlayed on valve frame 10 and be used to indicate 20 mesh of valve skirt, 221 position Mark point 12, meanwhile, when valve frame 10 is self-expansion type metallic support, is formed on the top of valve frame 10 and multiple dress be auxiliarily fixed 11 are set, auxiliary fixing device 11 with transportation system for being connected.
Wherein, in the present embodiment, the quantity of leaflet 40 is specially 2-6, and preferably 3, leaflet 40 is specifically by ox or pig Equal animals pericardium is made.
Step 2): on the inside of valve frame 10 sew valve skirt 20, and valve skirt 20 towards 10 top of valve frame one end through laser Cut or be knitted to form 221 structure of mesh, wherein the bottom end of leaflet 40 is lower than the lowermost end of 221 structure of mesh;
In the present embodiment, specifically, the side wall of valve skirt 20 is divided into two regions up and down, in the upper area of valve skirt 20 On open up mesh 221 so that the part of valve skirt 20 formed 221 structure of mesh, accordingly even when being implanted into through conduit aortic valve Depth and the height of coronary artery mouth are lower than 10mm, but make inner cavity and hat through conduit aortic valve by 221 structure of mesh Arteries and veins mouth can be connected to, and reduce the risk that coronary artery mouth is blocked in this way.
Wherein, in the present embodiment, the other parameters of valve skirt 20 can specifically refer to above-described embodiment, in the present embodiment no longer It repeats.
Step 3): sealed skirt 30 is sewed in the Basolateral of valve frame 10.
Wherein, in the present embodiment, the purpose for preventing side week from leaking can be played by sealed skirt 30, meanwhile, in order to guarantee valve 221 structure of mesh on skirt 20 is not covered by sealed skirt 30, and the top of sealed skirt 30 is not higher than the bottom end of 221 structure of mesh, Sealed skirt 30 is located at the Basolateral of valve frame 10, as long as sealing function can be played, the wherein material and setting of sealed skirt 30 Mode is repeated no more in the present embodiment with specific reference to above-described embodiment.
In the description of the present invention, it is to be understood that, term " center ", " longitudinal direction ", " transverse direction ", " length ", " width ", The instructions such as " thickness ", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom" "inner", "outside" Orientation or positional relationship is to be based on the orientation or positional relationship shown in the drawings, and is merely for convenience of the description present invention and simplification is retouched It states, rather than the device or element of indication or suggestion meaning must have a particular orientation, be constructed and operated in a specific orientation, Therefore it is not considered as limiting the invention.
In the description of the present invention, it is to be understood that, term " includes " used herein and " having " and they Any deformation, it is intended that cover it is non-exclusive include, for example, containing the process, method of a series of steps or units, being System, product or equipment those of are not necessarily limited to be clearly listed step or unit, but may include be not clearly listed or For the intrinsic other step or units of these process, methods, product or equipment.
Unless otherwise clearly defined and limited, term " installation ", " connected ", " connection ", " fixation " etc. should do broad sense reason Solution, such as may be a fixed connection, it may be a detachable connection, or be integrally formed;It can be directly connected, can also pass through Intermediary is indirectly connected, and can make the connection inside two elements or the interaction relationship of two elements.For this field Those of ordinary skill for, the specific meanings of the above terms in the present invention can be understood according to specific conditions.In addition, term " first ", " second " etc. are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance or implicitly indicate institute The quantity of the technical characteristic of instruction.
Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations;To the greatest extent Pipe present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: its according to So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into Row equivalent replacement;And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution The range of scheme.

Claims (15)

1. a kind of through conduit aortic valve, netted valve frame, valve skirt and multiple leaflets including expandable, wherein described Valve skirt is disposed around the inside of the valve frame, and the leaflet is located in the inner cavity of the valve frame, which is characterized in that the valve skirt divides For first area and second area, the first area is towards the inflow end of the aortic valve, the second area direction The outflow end of the aortic valve, and the mesh that can will be connected to inside and outside the valve frame is opened up on the second area.
2. according to claim 1 through conduit aortic valve, which is characterized in that the bottom end of the leaflet is in vertical direction The upper mesh lower than lowermost end on the second area.
3. according to claim 1 through conduit aortic valve, which is characterized in that the lowermost end of the second area and institute The distance between bottom of aortic valve is stated between 0~50mm.
4. according to claim 1 through conduit aortic valve, which is characterized in that all nets on the second area The total open area in hole accounts for the 30~50% of the second area gross area.
5. according to claim 1 to 4 through conduit aortic valve, which is characterized in that the shape of the mesh is circle One or more of shape, polygon and irregular polygon.
6. according to claim 1 to 4 through conduit aortic valve, which is characterized in that further include: sealed skirt, it is described Sealed skirt is disposed around the Basolateral of the valve frame, and the sealed skirt is close for will carry out between the aortic valve and annulus Envelope.
7. according to claim 1 to 4 through conduit aortic valve, which is characterized in that the Basolateral of the valve frame It is equipped with the mark point that can develop, the identification point is used to indicate the position of the mesh.
8. according to claim 7 through conduit aortic valve, which is characterized in that the mark point is platinumiridio or tantalum Mark point made of alloy.
9. according to claim 1 to 4 through conduit aortic valve, which is characterized in that the valve frame is using NiTi Alloy, stainless steel or cochrome self-expansion type or balloon expandable made of laser engraving, electrochemical polish and heat treatment Formula metallic support.
10. according to claim 9 through conduit aortic valve, which is characterized in that the valve frame is self-expansion type metal When bracket, the top of the valve frame is equipped with multiple auxiliary fixing devices, and the auxiliary fixing device with transportation system for being connected.
11. according to claim 10 through conduit aortic valve, which is characterized in that the quantity of the auxiliary fixing device It is 2-6, and the auxiliary fixing device is round, semicircle, T-type or S type.
12. according to claim 6 through conduit aortic valve, which is characterized in that the valve skirt, the sealed skirt and institute Leaflet is stated to be sewn on the valve frame by sewing mode.
13. according to claim 6 through conduit aortic valve, which is characterized in that the valve skirt and the sealed skirt Material include it is following any one: polyethylene terephtalate, polytetrafluoroethylene PTFE, bovine pericardium or Pigs Hearts pack At;
The leaflet is packed into using ox or Pigs Hearts.
14. according to claim 1 to 4 through conduit aortic valve, which is characterized in that the quantity of the leaflet is 2-4.
15. a kind of production method through conduit aortic valve, which is characterized in that the described method includes:
Multiple leaflets are sewed in the inner cavity of valve frame;
Valve skirt is sewed on the inside of the valve frame, and the one end on the valve skirt towards valve frame top is cut by laser or is compiled Knit to be formed it is mesh-structured, wherein the bottom end of the leaflet be lower than the mesh-structured lowermost end;
Sealed skirt is sewed in the Basolateral of the valve frame.
CN201810694112.XA 2018-06-29 2018-06-29 It is a kind of through conduit aortic valve and preparation method thereof Pending CN109124829A (en)

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US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
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US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
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CN114271992A (en) * 2021-12-15 2022-04-05 中国医学科学院阜外医院 Self-expanding valve for transfemoral delivery of aortic regurgitation
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US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve
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US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
CN109985274A (en) * 2019-03-28 2019-07-09 北京航空航天大学 Organizational project with regeneration function is through conduit valve skirt body and preparation method thereof
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11179239B2 (en) 2019-08-20 2021-11-23 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
WO2022057252A1 (en) * 2020-09-15 2022-03-24 深圳市健心医疗科技有限公司 Implant
CN113876470A (en) * 2021-10-26 2022-01-04 金仕生物科技(常熟)有限公司 Aortic intervention valve
CN114271992A (en) * 2021-12-15 2022-04-05 中国医学科学院阜外医院 Self-expanding valve for transfemoral delivery of aortic regurgitation
CN114271992B (en) * 2021-12-15 2022-09-02 中国医学科学院阜外医院 Self-expanding valve delivered through femoral artery access suitable for aortic valve regurgitation

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