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Kushandisa PTFE coatings mune intravascular medical devices

Dr BP van der Wal, Merit Medical Coatings naCharles Fields, Whitford Corporation, vanokurukura kushandiswa kwePTFE coatings mu intravascular medical devices.

 

Pave nekukurukurirana kwakawanda nezve PTFE coatings mumusika wevascular medical device.Muna Mbudzi, 2015 iyo FDA yakapa chengetedzo yekutaurirana ichiratidza mhedzisiro yekuputira delamination pane intravascular zvishandiso pazvitsitsinho zvezvakawanda zvakashumwa zviitiko.Kwemakore mazhinji, machira ePTFE anga ari mudiwa akanyarara, achideredza kupokana zuva rega rega mukuita catheterization.Ivo vaita ubiquitous, commodity kupera pane yakajairika catheter zvikamu.

Kuenderera mberi kwekutonga kudzvinyirira muindasitiri yemakemikari inogara ichimanikidza shanduko.Vaverengi vanogona kuyeuka kuti PFOA (Perfluorooctanic acid) yakadzorwa kunze kwerukova rwekugadzira fluoropolymer.Shanduko iyi yakave nemhedzisiro pane zvese zviri zviviri kuita kwekuvhara uye zvinodiwa zvekushandisa.Ichi hachisi chiitiko chitsva.Vagadziri vezvipfeko vanogara vachimanikidzwa kubata nekushanda kwekuchinja kwezvinhu zvinosanganisira zvinonyungudutsa, pigment, uye resin.Izvi hazvisanganise zvakanaka nemusika wemidziyo yekurapa.Nepo indasitiri yezvishandiso zvekurapa iine maitiro ekutarisana nekuchinja kwezvinhu, zvinoita kunge inotora nguva uye kazhinji inodhura kuita kuita.Shanduko idzi dzinoita kunge dziri kuwedzera sezvo zvinodiwa zvepasi rose zvezvakasvibira uye zvakachengeteka zvigadzirwa zvinova mutyairi akakomba.Zvigadzirwa zvemazuva ano zviri kuongororwa zvinosanganisira Chrome 6 (hexavalent chromium) uye NMP (N-methyl-2-pyrrolidone).Izvi zvinhu zvakakosha mukugadzira akawanda efluoropolymer (PTFE) coatings anoshandiswa pane catheter components.Vagadziri vemidziyo yekurapa yeVascular vanozoda kugadzirira kugarisa shanduko idzi dzekupfeka kuti ive nechokwadi chekuti maitiro ekupfekedza anosangana nezvinodiwa zvekupedzisira-kushandisa.

Merit Medical Coatings, iyo ine waya yekupfekedza nzvimbo iri muVenlo, Netherlands, yanga ichitora nzira yekugadzirisa matambudziko ari kuiswa paindasitiri yefluoropolymer.Dr BP van der Wal, injinjiniya mukuru akati: “Kushandiswa kwe (PTFE) machira kumawaya ekurapa kunoda hunyanzvi hwakakura.Hukuru hudiki uye kuchinjika kwezvishandiso zvakawanda zvekurapa zvinoita kuti nzira yekuputira inonetsa uye yakasiyana zvachose neiyo yekupfekedza maitiro eakafuratira uye akaomarara substrates senge cookware.Kudzikira kwakadzikira kwekupisa kwema substrates sewaya kunoda nguva dzakasiyana dzekugadzirisa uye tembiricha.

Kune nzira mbiri dzakasiyana dzekushandisa kwekuputira: Pre-coating uye post-coating.Mune pre-coating process, jira rinoshandiswa kune substrate pamberi pegungano.Kazhinji, iyo pre-coating process inoshandiswa kune yakakwirira-vhoriyamu yekugadzirisa iyo iyo substrate inobvumira reel-to-reel kugadzirisa.Pre-coating inzira inoenderera inobvumira kumhanya kwepamusoro kwekuputira uye inopindirana yekupfeka mhedzisiro yereel yakazara yezvinhu.Kune maguidewires, izvi zvinoreva kuti iyo yekupfeka inoiswa kune waya mune reel-to-reel process isati yakochekera.Iko kupfekedza saka kunofanirwa kumirisana nemasimba ese anoshandiswa mukusangana.Semuenzaniso, iyo yekupfeka haifanirwe kudonha kubva pawaya panguva yekukoira.Izvi zvinoda zvakawanda kubva pakuputira nekuda kwemasimba makuru akaiswa kune waya uye zvinokonzeresa deformation.Maparamita akadai sehukobvu hwekuputira akakosha kuita kuti iyo yekupfeka ichinjike uye yakasimba zvakakwana.

Mune post-coating, iyo catheter waya yekusangana maitiro akatopera.Post-coating ibasa rebatch uye inosarudzwa kana iyo substrate isingabvumire reel-to-reel kugadzirisa, senge waya ine muromo wepasi.Post-coating inopawo kuchinjika kwakawanda kungopfekedza chikamu che substrate.Nekuvhara chikamu che substrate, mabhendi emakaka anogona kusiiwa pamusoro.Iyo inotevera yakaoma firimu haifanirwe kumirisana neakakwira mechanical masimba ekukoira uye mamwe waya ekugadzira maitiro.Izvi hazviiti kuti iyo coating application iite zvishoma.Ne pre-coating process coating adhesion kukundikana kwaizoonekwa panguva yegungano.Ne post-coating process coating adhesion kutadza kungangoitika panguva yekubata murwere kana ikasabatwa panguva yeQA-kuongorora.Iyi inogona kuve mamiriro ane njodzi achiisa zvakakomba zvinodikanwa pane iyo coating application maitiro.

Kune fluoropolymer coatings, iyo isiri-tsvimbo pfuma uye yakanaka kunamatira kune substrate inopesana.Pamusoro pezvo, waya dzekurapa dzinowanzo kuvakwa nesimbi inert inert, senge 304 Stainless simbi neNitinol, zvichiwedzera kuomesa kupisa uye pretreatment process.Kazhinji-multi-layer coatings anoshandiswa kuwana adhesion yakanaka kune substrate uchishandisa binder layer uye fluoropolymer rich top coat.Ehe, izvi zvinoita kuti iyo yekubatisa application process iwedzere kuomarara nekuti akawanda ma layer anofanirwa kuiswa.Pakave neakawanda matsva ejaketi magadzirirwo umo-jasi masisitimu akagadzirwa achipa maitiro akafanana: kunamatira kwakanaka kune substrate uye fluoropolymer rakapfuma topcoat.Maitiro ekupfekedza, zvisinei, anokanganisa zvakanyanya kushanda kweiyi yekuzvimisa-stratification maitiro.


Nguva yekutumira: Jul-01-2017