Kumagumbi otyando, kwiiklinikhi zamazinyo, kunye namagumbi okwenziwa kwezixhobo zonyango, Iteyiphu ye-PTFE yobushushu obuphezulu ikuyo yonke indawo - kodwa ihlala ifihliwe. Ikhusela iitreyi zokuvala inzala ekuncamatheleni, iidyasi zeentambo zokuhamba lula, kwaye yenza isiseko sokumiliselwa kwemithambo.
Ndiyabulela ku-inertness yayo yeekhemikhali, ukukhuhlana okuphantsi, kunye nokuzinza kwe-thermal, i-PTFE yenye yezona zinto zisetyenziswa kakhulu kwi-fluoropolymers kwizicelo zonyango. Kodwa wazi njani ukuba yeyiphi iteyiphu ye-PTFE ilungele ukusetyenziswa kwezonyango? Impendulo ixhomekeke kuhlobo loqhagamshelwano (uqhagamshelwano oluthe ngqo lwesigulane vs. olungathanga ngqo), imigangatho yokulawula (i-FDA, i-ISO 10993), kunye nemeko yesicelo.
I-Aokai PTFE ibonelele ngemathiriyeli ye-PTFE kwizicelo zonyango iminyaka. Eli nqaku lihlula izicelo zonyango ngokwenqanaba loqhagamshelwano, lichaza imigangatho yokulawula engundoqo, kwaye inika isikhokelo sokhetho olusebenzayo.
Udidi |
Eqhelekileyo PTFE Tape Applications |
Iimfuno ezingundoqo |
Usetyenziso lwezonyango olungundoqo (uqhagamshelwano oluthe ngqo/ olungathanga ngqo lwesigulane) |
Iinaliti ze-Suture (i-low-friction coating); i-catheter/guidewire unyango lomphezulu; iingubo zamanxeba (i-non-adhesive backing); i-vascular grafts kunye ne-cardiac patches (e-PTFE); ukwahlulwa kweengcambu zamazinyo |
I-Biocompatibility (ISO 10993), ukuzinza kweekhemikhali, uvakalelo oluphantsi, ukuhambelana kwegazi |
Ukwenziwa nokulungiswa kwezixhobo zonyango |
I-autoclave tray kunye nokukhusela igumbi; ukupakishwa kwe-heat-seal (iipakethi ze-blister, iingxowa ze-IV); isixhobo sokutyanda ukubamba ukutyabeka; izixhobo zokugquma umbane |
Ukumelana nobushushu obuphezulu (≥260°C kwimijikelo yokuvala inzala), ukuxhathisa ukutyiwa kweekhemikhali, ukucocwa lula, ukungabambeki. |
Ilebhu kunye nokhuseleko lwemizi-mveliso jikelele |
Ukukhuselwa komphezulu we-chemical analyzer; i-biosafety cabinet liners; isixhobo sonyango se-casing seals; umbhobho wokuvala umhlwa |
Ukumelana nemichiza, ukusebenza kokutywinwa, umsebenzi wokukhusela |
I-PTFE's biocompatibility iye yasekwa kumashumi eminyaka yokusetyenziswa kwezonyango. I-PTFE ifumene imvume ye-FDA kwizicelo ze-vascular in the 1960s -, kunye ne-PTFE eyandisiweyo (e-PTFE) ukususela ekubeni yinto eqhelekileyo yezixhobo ezifakelwayo.
Isicelo |
Ukusetyenziswa ngokuthe ngqo |
Ipropati engundoqo ye-PTFE |
Ukuthunga utyando |
Ukugquma okusezantsi kwiinaliti zokuthunga kwenza ukuba kungene izicubu ezigudileyo |
I-coefficient yokhuhlane ephantsi kakhulu |
Catheter & guidewire ukutyabeka |
Ukugquma kwe-PTFE kunciphisa ingxabano phakathi kwe-guidewire kunye nodonga lwenqanawa, ukuphucula ukuhamba nge-tortuous anatomy. |
Amandla aphantsi asisigxina; akukho hydration efunekayo kwi-lubricity |
Ukunxitywa kwamanxeba |
Ukuxhaswa okungabambekiyo okuphefumlayo kuthintela ukulimala kwezicubu zesibini ngexesha lokutshintsha ukugqoka |
Amandla aphantsi komhlaba, ukungena komoya |
Ukufakelwa kwemithambo kunye namabala entliziyo |
Imithanjana yegazi eyenziweyo ye-e-PTFE encinci ye-diameter; i-e-PTFE edibeneyo yokufakelwa kwemithambo yegazi (umzekelo, i-CoreVascu) ingena kulingo lwezonyango. |
I-biocompatibility egqwesileyo, i-gradient microporous structure, i-antithrombotic |
unyango lwengcambu yamazinyo |
I-PTFE inwebu esetyenziswa njengesixhobo sokwahlula phakathi kweengcambu zeengcambu |
I-Biocompatibility, ukuzinza kweekhemikhali |
Ingqiqo ephambili: Kwizicelo ezifakelwayo, i-PTFE ayisetyenziswa njengeteyiphu kodwa njengezinto ezikrwada ezicutshungulwe kwiifom ezithile (umzekelo, i-e-PTFE vascular grafts, patches). I-Aokai PTFE ibonelela nge-PTFE imathiriyeli ekrwada ukuba abavelisi besixhobo bayiqhube ngakumbi kwezi zicelo.
Ukwenziwa kweZixhobo zezoNyango kunye noKusetyenzwa kwezicelo
Apha kulapho iteyiphu ye-PTFE ephezulu yobushushu isetyenziswa ngokuthe ngqo kwifomu yayo ye tape.
1. Ukhuseleko lweZixhobo zokuSebenza
Indlela yokuvala inzala |
PTFE Tape Function |
Ukusebenza |
I-autoclave yomphunga (121-134°C) |
Khusela iitreyi kunye neendonga zegumbi; ukuthintela ukunamathela kwezitywina / iigaskets |
Ukumelana nemijikelo ephindaphindiweyo yobushushu obuphezulu |
EtO inzala |
Ukukhuselwa komphezulu ngexesha lokuvala igesi |
Ukumelana neekhemikhali; akukho kuthotywa |
I-Gamma irradiation |
Ukhuseleko lwexeshana elifutshane (luxhomekeke kwidosi) |
Incinci - jonga inqaku langaphambili malunga nokumelana nemitha |
Iiteyiphu ezisekwe kwi-PTFE zimelana nemijikelo yokuvala inzala eqhelekileyo kuquka i-autoclave yomphunga, i-EtO, kunye neentsholongwane ezininzi zeekhemikhali.
2. Ukupakishwa kwe-Heat-Seal
Kwi-packaging ye-blister yonyango kunye nemigca yokutywinwa kwengxowa ye-IV, i-PTFE tape ifakwe kwimivalo yokufudumeza ukufikelela ngokukhawuleza, ukutywinwa okucocekileyo ngaphandle kokudluliselwa kwe-adhesive kwi-pouch material. Iiteyiphu zefilimu ye-PTFE zigcina uzinzo olunomlinganiselo kunye nokusebenza kwe-thermal ngapha -73 °C ukuya kuma-260 °C, ukuthintela ukuhanjiswa kwepolymer ngexesha lokuvalwa kwesingxobo-.
3. Unyango Lwezixhobo Zotyando kumphezulu
Isicelo |
Inzuzo |
Isixhobo sokubamba ukutyabeka |
I-Anti-slip, i-ergonomic grip |
Isikhokelo somzila kaloliwe |
Intshukumo egudileyo yomgca, ukunciphisa ukuveliswa kwamasuntswana |
Ukufakwa kombane kwisixhobo sangaphakathi |
Amandla e-Dielectric, ukuzinza kwe-thermal |
I-Aokai PTFE ibonelela ngeteyiphu ye-PTFE yobushushu obuphezulu kwizixhobo zokupakisha zonyango kunye nokhuseleko lwetreyi yokuvala inzala. Iiteyiphu zethu zifumaneka nge-silicone ye-adhesive-sensitive adhesive, ekwazi ukumelana nokujikeleza okuphindaphindiweyo kwe-autoclave ngaphandle kwe-adhesive residu.
ImiGangatho yoLawulo ye-PTFE yezoNyango
1. I-FDA 21 CFR 177.1550 - Ukuthotyelwa kweSiseko
I-FDA 21 CFR 177.1550 isisiseko solawulo lwe-US lokuTya kunye noLawulo lweDrug lwe-fluoropolymer resins. Ukuthotyelwa kuqinisekisa ukuba izinto ze-PTFE zikhuselekile ukuba zisetyenziswe ngokuphindaphindiweyo xa udibana nokutya - kwaye ngokongezwa, ngumgangatho oqhelekileyo wereferensi ye-PTFE yonyango.
Ukwahlula okubalulekileyo: I-FDA ayivumi izinto eziluhlaza; ivuma izixhobo zonyango ezigqityiweyo. Xa umthengisi esithi i-PTFE 'ivunyiwe yi-FDA,' bathetha ukuba imathiriyeli ihambelana ne-21 CFR 177.1550 - eneneni kumgangatho woqhagamshelwano lokutya-. Kwizixhobo zonyango, ulwamkelo lokugqibela luxhomekeke ekungenisweni okupheleleyo komenzi wesixhobo kwi-FDA.
2. ISO 10993 - Uvavanyo lwe-Biocompatibility
Kwizicelo zoqhagamshelwano oluthe ngqo lwesigulane, i-PTFE kufuneka ivavanywe ngokwe-ISO 10993 series:
Uvavanyo |
Umgangatho |
Iinqobo zokwamkeleka |
Cytotoxicity |
ISO 10993-5 |
Ukusebenza kweSeli ≥70%- |
Uvakalelo |
ISO 10993-10 |
inqaku lokwazisa ≤1 |
Ukucaphuka |
ISO 10993-10 |
Isalathisi sokucaphuka ≤2 |
Hemocompatibility |
ISO 10993-4 |
Izinga le-Hemolysis, ukuthambekela kwe-thrombosis |
Ukufakelwa |
ISO 10993-6 |
Impendulo evuthayo ifakwe kwinqanaba le-0-4 |
Izinto ze-PTFE zivavanywa ukuze kuqinisekiswe ukuba akukho tyhefu yeseli, akukho mvakalelo, kwaye akukho mpendulo yetyhefu xa udibana nezicubu zomntu.
Isishwankathelo kunye neSikhokelo soKhetho
Ukuba isicelo sakho sibandakanya... |
Khetha iteyiphu ye-PTFE? |
Ingqwalaselo ephambili |
Uqhagamshelwano oluthe ngqo lwesigulana (izihlomelo) |
Hayi njengeteyiphu – sebenzisa imathiriyeli ekrwada ye-PTFE |
Kufuneka imvume ye-FDA yenqanaba lesixhobo; Uvavanyo lwe-ISO 10993 lunyanzelekile |
Ukhuseleko lwezixhobo zokuvala inzala |
✅ Ewe |
Ifuna i-silicone PSA ekwazi ukumelana nemijikelo ye-autoclave ephindaphindiweyo (121-134 ° C) |
Ukupakishwa kwe-Heat-seal |
✅ Ewe |
Iteyiphu yefilimu ye-PTFE ikhethwayo; qinisekisa ukuhambelana kobushushu bokutywina |
Isixhobo sotyando sokugquma umphezulu |
✅ Ewe |
Qinisekisa ukuba i-biocompatibility ye-adhesive ukuba uqhagamshelwano lwesigulane lunokwenzeka |
Ukhuseleko lwezixhobo zeLebhu / ezingezizo isigulane |
✅ Ewe |
Iteyiphu yePTFE esemgangathweni ngokwaneleyo |
Isishwankathelo , iteyiphu yobushushu obuphezulu be-PTFE ibonelela ngamanqanaba amathathu ezicelo zonyango. Kwizicelo ezingundoqo zonyango (uqhagamshelwano oluthe ngqo lwesigulana), i-PTFE isetyenziswa njengemathiriyeli ekrwada (kungekhona njengeteyiphu) kunye nenqanaba lesixhobo imvume ye-FDA kunye novavanyo lwe-ISO 10993 lwe-biocompatibility. Ukwenziwa kwesixhobo sonyango kunye nokusetyenzwa - ukhuseleko lwezixhobo zokuvala inzala, ukupakishwa kobushushu, kunye nonyango lomphezulu wesixhobo - iteyiphu ye-PTFE ingasetyenziswa ngokuthe ngqo, kunye ne-silicone ye-PSA ecetyiswayo kwimo ye-autoclave.
Uthotyelo lolawulo luqala nge-FDA 21 CFR 177.1550 yokhuseleko oluphathekayo, kodwa imvume yokugqibela yesixhobo ifuna ukungeniswa komenzi. Kwizicelo ezibaluleke kakhulu zokunxibelelana nesigulana, soloko uqinisekisa uvavanyo lwe-biocompatibility kwimveliso egqityiweyo, hayi nje imathiriyeli ekrwada.
Ngaba ufuna iteyiphu yePTFE okanye imathiriyeli ekrwada kwisicelo sonyango? I-Aokai PTFE ibonelela ngemveliso ye-PTFE yonyango. Qhagamshelana nathi ngeenkcukacha zesicelo sakho, indlela ekujoliswe kuyo yokuvala inzala, kunye neemfuno zolawulo.
Olu lwazi lungentla lunikezelwa ngu I-Jiangsu Aokai yeZixhobo eziNtsha zeTekhnoloji Co., Ltd.
Ukuba unqwenela ukwazi ngakumbi malunga neeparitha ezineenkcukacha, iimeko zesicelo, kunye nezisombululo ezilungiselelwe uluhlu olupheleleyo lwemveliso, kubandakanya i-PTFE i-high-temperature tape, i-PTFE high-temperature tape, i-PTFE high-temperature mesh belt, i-seamless yebhanti yomshini wokuthunga, ilaphu le-PTFE elinecala elinye, i-high-temperature resistant conveyorate, i-high-temperature resistant conveyorglass . thina:
Ukugcina ifilosofi yobungcali kunye nokuthembeka, sizibophelele ekuboneleleni izisombululo zokuphela kunye neenkonzo ezicingayo kubo bonke abathengi.
