UGqr BP van der Wal, i-Merit Medical Coatings kunye noCharles Fields, i-Whitford Corporation, baxoxe ngokusetyenziswa kweengubo ze-PTFE kwizixhobo zonyango ze-intravascular.
Kukho ingxoxo eninzi malunga neengubo ze-PTFE kwimarike yesixhobo sonyango se-vascular.NgoNovemba, i-2015 i-FDA ikhuphe unxibelelwano olukhuselekileyo olubhekiselele kwimiphumo ye-coating delamination kwi-intravascular devices kwizithende zeziganeko ezininzi ezixeliweyo.Kwiminyaka emininzi, iingubo ze-PTFE zibe liqabane elithuleyo, linciphisa ukungqubuzana yonke imihla kwiinkqubo ze-catheterization.Ziye zaba yinto yonke indawo, isiphelo sempahla yorhwebo kumalungu asemgangathweni wecatheter.
Uxinzelelo oluqhubekayo lokulawula kwishishini lemichiza lihlala linyanzelisa utshintsho.Abafundi banokukhumbula ukuba i-PFOA (Perfluorooctanic acid) yayilawulwa ngaphandle kwe-fluoropolymer production stream.Olu tshintsho lwaba nefuthe ekusebenzeni kokugquma kunye neemfuno zesicelo.Le asiyonto intsha.Abavelisi bezogquma basoloko benyanzelwa ukuba bajongane notshintsho olusebenzayo lwemathiriyeli ekrwada kubandakanywa izinyibilikisi, ii-pigments, kunye ne-resins.Oku akudibanisi kakuhle nemarike yezixhobo zonyango.Ngelixa ushishino lwezixhobo zonyango luneenkqubo zokujongana nokutshintsha kwezinto, kudla ngokuba luxanduva oludla ixesha kwaye oluhlala lubiza ukulwenza.Olu tshintsho lubonakala lukhula njengoko iimfuno zehlabathi zeemveliso eziluhlaza kunye nezikhuselekileyo ziba ngumqhubi onzima kakhulu.Imathiriyeli ekrwada yangoku evavanywayo ibandakanya iChrome 6 (ihexavalent chromium) kunye ne-NMP (N-methyl-2-pyrrolidone).Ezi zixhobo eziphambili ekwenziweni kweengubo ezininzi ze-fluoropolymer (PTFE) ezisetyenziswa kumacandelo e-catheter.Abavelisi bezixhobo zonyango lwe-Vascular baya kufuneka balungiselele ukulungiselela olu tshintsho lokwambathisa ukuqinisekisa ukuba iinkqubo zokugquma ziyahlangabezana neemfuno zabo zokuphela kokusetyenziswa.
IMerit Medical Coatings, indawo yayo yokugquma ucingo ibekwe eVenlo, eNetherlands, ibithatha indlela esebenzayo yokujongana noxinzelelo lolawulo olubekwe kushishino lwefluoropolymer.UGqr BP van der Wal, injineli ephezulu uthe: "Ukusetyenziswa kwe-(PTFE) yokwambathisa kwiingcingo zonyango kufuna ubuchule obuninzi.Ubungakanani obuncinci kunye nokuguquguquka kwezixhobo ezininzi zonyango zenza inkqubo yokugquma ibe ngumngeni kwaye ihluke ngokupheleleyo kwinkqubo yokugquma i-flat and rigid substrates ezifana ne-cookware.Umthamo osezantsi kakhulu wobushushu kwiisubstrates ezinje ngeengcingo kufuna amaxesha okusebenza ahluke ngokupheleleyo kunye nobushushu.”
Kukho iindlela ezimbini ezihlukeneyo zokusetyenziswa kwe-coating: I-pre-coating kunye ne-post-coating.Kwinkqubo yokugubungela kwangaphambili, i-coating isetyenziswe kwi-substrate ngaphambi kokuhlanganisana.Ngokubanzi, inkqubo yokugquma kwangaphambili isetyenziselwa ukucwangcisa umthamo ophezulu apho i-substrate ivumela ukuqhutyelwa kwe-reel-to-reel.I-pre-coating yinkqubo eqhubekayo evumela isantya esiphezulu sokugquma kunye nesiphumo esihambelanayo sokwaleka kwi-reel epheleleyo yezinto.Kwii-guidewires, oku kuthetha ukuba i-coating isetyenziswe kwi-reel-to-reel process ngaphambi kokuba i-coiling.Ngoko ke, i-coating kufuneka imelane nayo yonke imikhosi esetyenziswa kwinkqubo yendibano.Ngokomzekelo, ukugquma akufuneki ukuba kufakwe i-delaminate ukusuka kwi-wire ngexesha le-coiling.Oku kufuna kakhulu kwi-coating ngenxa yamandla aphezulu afakwe kwi-wire kunye nokuguqulwa kwesiphumo.Iiparamitha ezinjengobungqingqwa bokugquma zibalulekile ukwenza i-coating ibe bhetyebhetye kwaye yomelele ngokwaneleyo.
Kwi-post-coating, iinkqubo zokuhlanganisa ucingo lwe-catheter sele zigqityiwe.I-Post-coating yinkqubo ye-batch kwaye ikhethwe ukuba i-substrate ayivumeli ukuqhutyelwa kwe-reel-to-reel, njengocingo olunencam yomhlaba.I-Post-coating iphinda inike ukuguquguquka okungakumbi ukugqoka kuphela inxalenye ye-substrate.Ngokufihla inxalenye ye-substrate, iibhendi zokumakisha zingashiywa phezu komhlaba.Ifilimu eyomileyo elandelayo ayifuneki ukuba imelane nemikhosi ephezulu ye-coiling kunye nezinye iinkqubo zokuvelisa ucingo.Oku akwenzi ukuba isicelo sokugquma sibe sincinci.Ngenkqubo yokwaleka kwangaphambili ukusilela kokuncamathela kuya kubonwa ngexesha lenkqubo yendibano.Ngenkqubo yokugquma i-post-coating, ukusilela kokunamathela kuya kwenzeka ngexesha lokudibana kwesigulane ukuba ayibanjwanga ngexesha lokuhlolwa kwe-QA.Oku kunokuba yimeko enobungozi ebeka iimfuno ezinzulu kakhulu kwiinkqubo zokufaka isicelo sokugquma.
Kwiingubo ze-fluoropolymer, ipropati engabonakaliyo kunye nokubambelela kakuhle kwi-substrate iyaphikisana.Ukongeza, iingcingo zonyango ziqhele ukwakhiwa ngeentsimbi ezingasebenzi kakuhle, ezinje nge-304 yentsimbi engatyiwayo kunye neNitinol, nto leyo eyenza nzima ngakumbi inkqubo yokufudumeza kunye nonyango lwangaphambili.Amaxesha amaninzi iileya ezininzi zisetyenziselwa ukufumana ukunamathela kakuhle kwi-substrate usebenzisa i-binder layer kunye ne-fluoropolymer rich coat top.Ewe kunjalo, oku kwenza inkqubo yokufaka isicelo sokwambathisa intsonkothe ngakumbi kuba kufuneka kusetyenziswe iileya ezininzi.Kubekho uphuhliso olutsha lweengubo apho iinkqubo zengubo enye ziye zaphuhliswa zinika umphumo ofanayo: ukunamathela kakuhle kwi-substrate kunye ne-fluoropolymer rich topcoat.Inkqubo yokwaleka, nangona kunjalo, inefuthe elikhulu ekusebenzeni kwale nkqubo yokuzihluza.
Ixesha lokuposa: Jul-01-2017