CN105662654A - Coronary artery protecting device - Google Patents

Coronary artery protecting device Download PDF

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Publication number
CN105662654A
CN105662654A CN201610105080.6A CN201610105080A CN105662654A CN 105662654 A CN105662654 A CN 105662654A CN 201610105080 A CN201610105080 A CN 201610105080A CN 105662654 A CN105662654 A CN 105662654A
Authority
CN
China
Prior art keywords
coronary artery
protective device
isolated part
coronary
artery protective
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
CN201610105080.6A
Other languages
Chinese (zh)
Inventor
潘文志
周达新
程蕾蕾
葛均波
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.)
Zhongshan Hospital Fudan University
Original Assignee
Zhongshan Hospital Fudan University
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 Zhongshan Hospital Fudan University filed Critical Zhongshan Hospital Fudan University
Priority to CN201610105080.6A priority Critical patent/CN105662654A/en
Publication of CN105662654A publication Critical patent/CN105662654A/en
Priority to CN201720161187.2U priority patent/CN207627445U/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
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

Abstract

The invention discloses a coronary artery protecting device which comprises an isolating part and a fixing part. The isolating part is used for isolating a potential obstacle from a coronary artery opening, and the fixing part is used for fixing the position of the isolating part. The device is provided with a grid structure, the grid structure is implanted into the joint portion of the ascending aorta and coronary artery through the peripheral arterial path, the grid structure is implanted before transcatheter aortic valve replacement, smoothness of blood flow in the coronary artery during the transcatheter aortic valve replacement operation and after the operation can be guaranteed, coronary occlusion complications is avoided, and therefore transcatheter aortic valve replacement can be achieved for an aortic valve disease patient whose ascending aorta root anatomical structure does not meet the current standard.

Description

A kind of coronary artery protective device
Technical field
The present invention relates to a kind of coronary artery protective device, relate in particular to a kind of for rotate arteries and veins valved prosthesis art through conduitCoronary artery protective device.
Background technology
The current heart through conduit aortic valve replacement (TAVR, transcatheteraorticvalvereplacement)The popular new technology that blood vessel is got involved, this technology is to send into interposing catheter by peripheral arterial, will compress by interposing catheterHeart valve prosthesis be delivered to aortic area and open, insert thereby complete artificial valve, recover valvular function,It is a kind of mode of inserting heart valve prosthesis of Wicresoft. The invasive of this technology is less than open heart operation, thereby greatly fallsThe low risk of cardiac operation, patient's the post-operative recovery time also shortens greatly, has become in the world at present masterThe narrow patient's of arterial valve first-line treatment scheme. TAVR prospect is generally had an optimistic view of at present, expects 2025, the whole worldComplete every year TAVR amount for surgical and will reach 300,000 example left and right.
But this technology is still a kind of high-risk operation at present, can cause fatal complication. Coronary artery stops upThe wherein high complication of the death rate, can cause acute myocardial infarction AMI, cardiogenic shock and lethal. Its main machineSystem is that autologous active is affectionately turned on valve and blocked coronary ostium. In addition, valve bracket is placed too high, makes to get involvedCoronary opening is blocked in valve shirt rim, also can cause that coronary artery blocks and myocardial infarction. Therefore, TAVR is preoperative should assess masterThe anatomical structure of artery root, comprises Wa Shi hole width (should than more than the large 3mm of valve model), Wa Shi hole height (should> 15mm) and coronary artery height (should > 12mm). If but carrying out case screening according to this standard, will have1/4 case is left out and cannot accepts TAVR operation. In addition, even if carry out TAVR according to this standard completelyOperation, still has minority case that coronary artery may occur and stops up. Therefore, research and development are for the dress of TAVR art coronary artery protectionPut, make many ineligible patients of aortic root condition also can manage it TAVR art, there is great social profitAnd the market demand.
Summary of the invention
Because the above-mentioned defect of prior art, technical problem to be solved by this invention is how for TAVR art providesProtection coronarius, avoids TAVR to cause the risk that coronary artery stops up.
For achieving the above object, the invention provides a kind of coronary artery protective device, this device is also through peripheral arterialApproach is implanted aorta ascendens and junction coronarius, before conduit aortic valve replacement, is implanting, and can ensureIn TAVR art and postoperative coronary flow unobstructed, avoid the generation of coronary occlusion complication, make to rise masterThe aortic valve disease patient that artery root anatomical structure does not meet current standard realizes the displacement through conduit aorta petal.
Coronary artery protective device provided by the invention comprises for by the isolation of potential obstacle and coronary ostiumIsolated part and for fixing the fixed part of this isolated part position, this isolated part and this fixed part interconnectTogether; The operating position of this isolated part is root of ascending aorta and junction coronarius. Wherein, described divingThe obstacle autologous active of turning on can being affectionately valve, get involved valve shirt rim or other anyly may cause hatThe object of shape artery occlusion.
This coronary artery protective device can convert between the first form of radial dilatation and the second form of radial contraction;Wherein, described the first form is the precalculated position of the implanted human body root of ascending aorta of this device and coronary artery junctionAfter working morphology, described the second form is that this device is by the conveying form in the time that conduit is carried.
Further, described the second form is fine strip shape, enable to be loaded in the strip delivery sheath of certain internal diameter,Deliver to root of ascending aorta from external along human body artery.
Preferably, this isolated part has network, can not affect flowing of blood; Further preferably, this isolationParts are tubulose, and blood can be from flowing into the inner chamber of this isolated part around; Further, the work of this tubulose isolated partBe the axial arranging along aorta ascendens as state.
Preferably, the operating position of this fixed part is in coronary artery, this fixed part by with coronary arterial wall itBetween stiction fix the position of this coronary artery protective device, to prevent that whole device displacement from coming off; FurtherPreferably, this fixed part is the tubulose with network; In this case, the diameter of section of its first formShould be applicable to internal diameter coronarius, with slightly greatly better than coronary artery diameter, conventionally be preferably 2-5mm; Preferably,The length of this fixed part is 2-6cm, described length also this fixed part enter the degree of depth coronarius.
Preferably, described tubulose is circular tube shaped or oval tubulose, and this structure has stronger support force, not yielding;For isolated part, after getting involved in the implanted aorta ascendens of valve, can produce contention effect to this isolated part, strongerSupport force can keep the unobstructed of blood flow in body; For fixed part, stronger support force can produce better frictionThereby effect is fixing more firmly, and also can keep the unobstructed of the interior blood flow of body.
Preferably, described network is network structure, and this structure can further improve support force; Form isolationThe grid lines of component netlist lattice structure can be slightly thicker than the grid lines of fixed part, because isolated part needs stronger supportPower.
Preferably, the diameter of described isolated part is 4-8mm, and the length of described isolated part is 5-15cm.
In a kind of preferred embodiment of the present invention, the tubulose that described isolated part and described fixed part are integrated,Centre has bending angle, and this coronary artery protective device self can form a bending angle in the time of the first form, and this is curvedThe scope of knuckle is preferably 60 °~150 °, and further this bending angle is fillet, does not have and sharply and easily causes machinery to damageThe outline of evil.
Aorta ascendens wall is connected with arteria coroaria sinistra and arteria coronaria dextra, in a kind of preferred embodiment of the present invention,Upwards extend from opening part coronarius the operating position of described isolated part, and a root of ascending aorta one side (left side reclinesOr right) inwall, and its height is higher than the height that is about to the intervention valve of implanting, so just at the aorta ascendens of this sideTo the passage that has set up a blood circulation between coronary ostium, can ensure the unimpeded of coronary flow.
Preferably, the distal end opening of the first form of this isolated part is larger, easily enters conduit and seal wire, favourableIn percutaneous coronary intervention in the future; The proximal part diameter of section of the first form of this isolated part can be equal to or greater thanThe maximum cross-section diameter of fixed part. In a kind of preferred embodiment of the present invention, the shape of this isolated part is preferredFor axial increase gradually to distal end horn-like along tubulose.
Arteria coroaria sinistra and arteria coronaria dextra, for heart provides blood flow, ensure blood supply, the oxygen supply of heart, described fixingParts are entered in left/right coronary artery by the left/right coronary ostium place on aorta ascendens wall. Due to left and right crownThe structure of artery has little difference, and therefore the form of fixed part of the present invention can be by left/right out of shape establishing coronariusMeter, the slightly larger in diameter of radial section is in internal diameter coronarius; Further isolated part also can by left/right coronary artery withDesign out of shape between aorta ascendens; Further, coronary artery protective device of the present invention can be done according to individual differencePersonalized designs, to meet the different demand of different crowd.
" distal end " of the present invention refer to the implanted root of ascending aorta of described device and junction coronarius pre-After allocation, away from one end of heart, " proximal part " refers to the implanted root of ascending aorta of described device and coronariusOne end of close heart behind precalculated position, junction.
Preferably, the overall length of described coronary artery protective device is 10-20cm.
Preferably, described coronary artery protective device is printed and is made by integrated 3D.
In a kind of preferred embodiment of the present invention, described coronary artery protective device is made up of self-expanding material,External second form that can be compressed into strip, can automatically restore to the first shape after discharging in vivo. In the present inventionAnother kind of preferred embodiment in, this device also can balloon expandable principle discharge, device be compressed in vitroThe second form of strip, loads on sacculus outside, arrives rear dilating sacculus releasing device in body, and device is returned toThe first form.
Preferably, described coronary artery protective device is made up of metal material; More preferably there is temperature memoryNickel-titanium alloy material.
In a preferred embodiment of the invention, the integrated pipe of described coronary artery protective device, has netLattice structure can convert between the first form of radial dilatation and the second form of radial contraction, and its first form hasBending angle, a side of this bending angle is isolated part, for by potential obstacle and coronary ostium isolation, is somebody's turn to doThe opposite side of bending angle is fixed part, for fixing the position of this isolated part, first of described integrated pipeForm is close to the anatomical structure of human body root of ascending aorta and coronary artery junction.
The present invention invents according to anatomical cardiac feature with through conduit aortic valve replacement know-why: through conduit masterWhen arterial valve displacement, after the intervention valve of implanting is fully expanded, may make autologous aortic valve be extrudedTurn over, stop up coronary ostium, get involved the shirt rim of valve and also may stop up coronary ostium, this protective device is plantedAfter entering, can, at the aorta ascendens in the outside of intervention valve to strutting a tunnel between coronary ostium, ensure blood flowFlow into coronary artery by aorta ascendens; On the other hand, the form of protective device meets aortic root anatomical features, energyGood fixing and do not dislocate; This device is positioned on autologous lobe ring, gets involved outside valve, therefore can not affect intervention lobeThe function of film and fixation, can not cause perivalvular leakage and valvular regurgitation.
The present invention has following useful technique effect:
1. operation is done simple: it is identical with current coronary artery bracket implantation process that body of the present invention is implanted into process, operation behaviourDo relatively simple.
2. make simple, ripe: stock of the present invention can adopt conventional coronary artery, vascular stent material, makeMethod also can adopt the rack making method of current routine, therefore make relatively simple, ripe.
3. safe: when this device is implanted and after implanting, not affect blood supply coronarius, do not affect human body lobeThe function of film or intervention valve.
4. do not affect coronary intervention: the opening of isolated part is larger, become horn-like, easily enter seal wire and conduit,Just in case coronary artery pathological changes occurs patient in the future, do not affect its PCI.
Below with reference to accompanying drawing, the technique effect of design of the present invention, concrete structure and generation is described further, withUnderstand fully object of the present invention, feature and effect.
Brief description of the drawings
Fig. 1 is the first form perspective view of a preferred embodiment of the present invention;
Fig. 2 is the top perspective view of preferred embodiment in Fig. 1;
Fig. 3 is operating position of the present invention anatomical structure schematic diagram.
Detailed description of the invention
Be illustrated in figure 1 the structural representation of the first form of a preferred embodiment of the present invention. This coronary artery is protectedProtection unit is the tubulose with network, comprises isolated part 1 and fixed part 2, between each parts of this deviceCan adopt conventional connected mode to connect, also can adopt integrated mode to be made.
In the present embodiment, the pipe that isolated part 1 and fixed part 2 are integrated, its first form is as shown in FIG.Be similar to alphabetical L-type, this pipe has the network of rhombus, forms curved between isolated part 1 and fixed part 2The fillet α of folding, the size of α is determined with the angle of the axis of isolated part 1 and the axis of fixed part 2, excellentElect 60 °~150 ° as; The grid lines of isolated part 1 is slightly thicker than the grid lines of fixed part 2, and larger propping up can be providedSupport force.
Structure of the present invention is not confined to L-type tubulose, and the structure that can realize arbitrarily isolation and fixed function is all feasible, as T-shaped tubulose, I type tubulose etc.; Mesh shape of the present invention is not unique yet, can meet arbitrarily blood flow circulation andThe shape that shrinkage expansion requires is all feasible.
As shown in Figure 2, the isolated part 1 of the present embodiment is trumpet-shaped pipe, along tubulose axially to distal end byCumulative large, as shown in Figure 3, the inwall of the root of ascending aorta that reclines, upwards arranges from coronary ostium in its operating positionCloth; The operating position of fixed part is in coronary artery. Can produce this isolated part 1 when getting involved after valve 3 is implantedContention effect radially, 1 of isolated part in the present embodiment has stronger support force, can keep blood flow in bodyUnobstructed, blood flow can successfully be flowed in coronary artery.
Outer wheels profile of the present invention is out of shape consistent with root of ascending aorta and the nearly section of coronary artery. The present invention can rootBe designed to two types, arteria coroaria sinistra type and arteria coronaria dextra type according to needs, the length of fixed part is 2-6cm, inFootpath is with slightly larger than about human body internal diameter coronarius, and support force can approach current existing coronary artery bracket, in order to avoid damageCoronary artery, and can be according to individual difference design personalized parameter, to meet the different coronary artery diameters of different human bodyDemand.
The length of isolated part is 5-15cm, and proximal part diameter can be equal to, or greater than the diameter of fixed part, distal endDiameter expand gradually, be horn-like opening. The radial support power of isolated part is larger, can resist and get involved valveCompressing, getting involved under valve compressing, still can keep circular tube shaped or oval tubulose form, and ensureing has tube chamber in isolated partSpace connects to fixed part.
The first form of the present embodiment device approaches L-type on the whole, still, and between isolated part 1 and fixed part 2By level and smooth round-corner transition, one connects, without acute angle, in order to avoid damage tissue, and the angle of this fillet while implantingAccording to the angle design of coronary artery and aorta ascendens, make can naturally fit in liter after the present embodiment device implant into bodySustainer inwall.
This device can convert between the first form of expansion and the second form of contraction, and the first form is planted for this deviceEnter the working morphology behind the precalculated position of human body root of ascending aorta and coronary artery junction, the second form is this deviceBy the conveying form in the time that conduit is carried. The principle that the present embodiment adopts self-expanding or balloon expandable to expand, in vitro,This device can be forced into strip, is positioned in induction system, arrives behind aortic root precalculated position, by oneselfExpand or balloon expandable, can return to the form of original design and there is higher hardness, and passing through fixed partEffect be firmly fixed in the precalculated position of root of ascending aorta.
The preparation method of the coronary artery protective device of the present embodiment is preferably laser-engraving technique, but this preparation method is notUnique, in other preferred embodiment, also can adopt integrated 3D printing technique to make.
Coronary artery protective device of the present invention can adopt following steps in the time that reality is implanted:
(1) in vitro, use compressing apparatus, described device is compeled into after fine strip shape, then inserted induction systemSheath pipe in;
(2) seal wire is inserted coronary artery from aorta ascendens path, along seal wire, the delivery sheath that device is housed is sentTo coronary artery;
(3) recession delivery sheath, device for opening;
(4) complete releasing device, exits induction system.
The aorta petal function that can not affect patient self after above-mentioned implantation step and implantation, does not affect coronary blood flow yet,After implantation, do not affect the function that gets involved valve, can after intervention valve is implanted, play again protection effect coronarius simultaneously,Avoid coronary ostium blocked.
More than describe preferred embodiment of the present invention in detail. Should be appreciated that those of ordinary skill in the art withoutNeed creative work just can design according to the present invention make many modifications and variations. Therefore, in the art allTechnical staff under this invention's idea on the basis of existing technology can by logical analysis, reasoning, or a limited experimentWith the technical scheme obtaining, all should be in by the determined protection domain of claims.

Claims (10)

1. a coronary artery protective device, is characterized in that described device comprises for by potential obstacle and coronary arteryThe isolated part of opening isolation and for the fixed part of fixing described isolated part position, described isolated part with described inFixed part interconnects; The operating position of described isolated part is root of ascending aorta and knot coronariusClose place; Described coronary artery protective device can become between the first form of radial dilatation and the second form of radial contractionChange.
2. coronary artery protective device as claimed in claim 1, is characterized in that described isolated part has network.
3. coronary artery protective device as claimed in claim 1, is characterized in that described isolated part is tubulose.
4. coronary artery protective device as claimed in claim 1, the operating position that it is characterized in that described fixed part is hatIn shape artery, and by and coronary arterial wall between stiction fix and prevent from coming off.
5. coronary artery protective device as claimed in claim 4, is characterized in that described fixed part is for having networkTubulose.
6. coronary artery protective device as claimed in claim 1, is characterized in that being shaped as along tubulose of described isolated partAxially increase gradually to distal end horn-like.
7. coronary artery protective device as claimed in claim 1, is characterized in that described isolated part and described fixed partIntegrated tubulose, centre has bending angle.
8. the coronary artery protective device as described in claim 1-7 any one, is characterized in that described device is by self-expandingMaterial forms.
9. the coronary artery protective device as described in claim 1-7 any one, is characterized in that described device expands with sacculusZhang Yuanli realizes convergent-divergent.
10. a coronary artery protective device, is characterized in that the pipe that described device is integrated, has network,Described coronary artery protective device can convert between the first form of radial dilatation and the second form of radial contraction, itsThe first form has bending angle, and a side of described bending angle is isolated part, for by potential obstacle and crown movingThe isolation of arteries and veins opening, the opposite side of described bending angle is fixed part, for the position of fixing described isolated part, described inThe first form of integrated pipe is close to the anatomical structure of human body root of ascending aorta and coronary artery junction.
CN201610105080.6A 2016-02-25 2016-02-25 Coronary artery protecting device Pending CN105662654A (en)

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Application Number Priority Date Filing Date Title
CN201610105080.6A CN105662654A (en) 2016-02-25 2016-02-25 Coronary artery protecting device
CN201720161187.2U CN207627445U (en) 2016-02-25 2017-02-22 A kind of coronary artery protective device

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Application Number Priority Date Filing Date Title
CN201610105080.6A CN105662654A (en) 2016-02-25 2016-02-25 Coronary artery protecting device

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CN201720161187.2U Active CN207627445U (en) 2016-02-25 2017-02-22 A kind of coronary artery protective device

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108309505A (en) * 2017-10-13 2018-07-24 杭州启明医疗器械有限公司 Thrombus protective device
CN111132636A (en) * 2017-09-27 2020-05-08 W.L.戈尔及同仁股份有限公司 Prosthetic valves with expandable frames and associated systems and methods

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WO2010081025A1 (en) * 2009-01-09 2010-07-15 Embrella Cardiovascular, Inc. Embolic deflection device and method of use
CN102014791A (en) * 2008-02-22 2011-04-13 巴兹和伦敦全民健康医疗服务基金会 Blood vessel prosthesis and delivery apparatus
CN102670333A (en) * 2012-06-08 2012-09-19 同济大学 Aortic valve stent with coronary artery and conveyor of same
WO2013036168A1 (en) * 2011-09-06 2013-03-14 Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж" Valved aortic root prosthesis
CN103945793A (en) * 2011-12-06 2014-07-23 俄奥梯科创新有限公司 Device for endovascular aortic repair and method of using the same

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101172055A (en) * 2006-09-28 2008-05-07 贝鲁斯研制厂 Implant for placing in a blood vessel
CN102014791A (en) * 2008-02-22 2011-04-13 巴兹和伦敦全民健康医疗服务基金会 Blood vessel prosthesis and delivery apparatus
WO2010026240A1 (en) * 2008-09-04 2010-03-11 Karolinska Institutet Innovations Ab Temporary embolic protection device and medical procedure for delivery thereof
WO2010081025A1 (en) * 2009-01-09 2010-07-15 Embrella Cardiovascular, Inc. Embolic deflection device and method of use
WO2013036168A1 (en) * 2011-09-06 2013-03-14 Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж" Valved aortic root prosthesis
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111132636A (en) * 2017-09-27 2020-05-08 W.L.戈尔及同仁股份有限公司 Prosthetic valves with expandable frames and associated systems and methods
CN111132636B (en) * 2017-09-27 2022-04-08 W.L.戈尔及同仁股份有限公司 Prosthetic valves with expandable frames and associated systems and methods
CN108309505A (en) * 2017-10-13 2018-07-24 杭州启明医疗器械有限公司 Thrombus protective device

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Application publication date: 20160615