I totonu o potu tipitipi, falema'i nifo, ma potu mama e gaosia ai masini, PTFE maualuga-vevela lipine i soo se mea - ae masani ona natia. E puipuia fata fa'ama'i mai le pipi'i, uaea ta'iala mo le fa'alelei le folauga, ma e fa'atūina fo'i le fa'avae o fa'apipi'i toto toto.
Faʻafetai i lona inertness vailaʻau, feteʻenaʻiga maualalo, ma le mautu vevela, PTFE o se tasi o le sili ona faʻaaogaina fluoropolymers i talosaga faafomaʻi. Ae fa'afefea ona e iloa po'o fea le lipine PTFE e talafeagai mo le fa'aoga fa'afoma'i? O le tali e fa'alagolago i le ituaiga fa'afeso'ota'i (fa'afeso'ota'i tu'usa'o ma'i vs. le tu'usa'o), tulaga fa'atonutonu (FDA, ISO 10993), ma le siosiomaga fa'aoga.
Ua saunia e Aokai PTFE meafaitino PTFE mo talosaga faafomai mo le tele o tausaga. O lenei tusiga o lo'o fa'avasegaina talosaga fa'afoma'i e ala i le fa'afeso'ota'i tulaga, fa'amatala tulaga fa'atonutonu autu, ma tu'uina atu ta'iala fa'atino filifiliga.
Tolu Fa'atonuga Fa'afoma'i Fa'asaga ile Laasaga Fa'afeso'ota'i
nila suture (fa'alavalava vaivai); catheter/guidewile togafitiga luga; fa'aofuina o manu'a (lagona e le pipi'i); fa'apipi'i ga'o ma pa'i fatu (e-PTFE); fa'amama a'a nifo
Biocompatibility (ISO 10993), mautu vailaʻau, maualalo lagona, fetaui toto
gaosiga ma le fa'agaioiina o masini fa'afoma'i
Autoclave fata ma potu puipui; fa'amaufa'ailoga fa'amaufa'ailoga vevela (fa'amau fa'apipi'i, taga IV); fa'apipi'i 'au o meafaigaluega tipitipi; mea fa'amama eletise
Tete'e maualuga-vevela (≥260°C mo ta'amilosaga fa'ama'i), fa'ama'i fa'ama'i, fa'amama faigofie, leai se la'au.
Falesu'esu'e & puipuiga lautele tau alamanuia
Puipuiga luga ole su'esu'ega vaila'au; kapoti mo le saogalemu o meaola; fa'amaufa'ailoga fa'amau masini fa'afoma'i; paipa fa'apipi'i anti-corrosion
O le biocompatibility a le PTFE ua fa'avaeina i le tele o tausaga o fa'aoga falema'i. Na maua e le PTFE le faʻamaoniga a le FDA mo faʻaoga vascular i le 1960s -, ma faʻalauteleina le PTFE (e-PTFE) talu mai lena taimi ua avea ma mea masani mo masini faʻapipiʻi.
Fa'atatauga
Fa'aoga Fa'apitoa
Meatotino PTFE autu
Su'iina taotoga
O le fa'apipi'i maualalo i nila suture e mafai ai ona fa'asolo i totonu o le tino
E matua maualalo le fa'ase'e
Catheter & uaea ta'iala
O le ufiufi PTFE e faʻaitiitia ai feteʻenaʻiga i le va o le taʻiala ma le puipui o vaʻa, faʻaleleia le faʻaogaina e ala i le tino faʻasolosolo.
Malosiaga maualalo maualalo tumau; leai se fa'asusu e mana'omia mo le lubricity
Fufulu manu'a
E le pipi'i le manava e puipuia ai le manu'a lona lua a'o suia laei
Malosi i luga maualalo, ea permeability
La'au fa'asusu ma fa'amau fatu
La'ititi laititi e-PTFE va'a toto fai; tu'ufa'atasiga e-PTFE fa'apipi'i ga'o (fa'ata'ita'iga, CoreVascu) o lo'o ulufale i fa'ata'ita'iga fa'apitoa.
E sili ona lelei le biocompatibility, gradient microporous structure, antithrombotic
Togafitiga a'a nifo
PTFE membrane faʻaaogaina e avea ma mea faʻaesea i totonu o aʻa
Biocompatibility, mautu vailaʻau
Malamalamaga autu: Mo faʻaoga faʻapipiʻi, e le faʻaaogaina le PTFE e fai ma lipine ae o mea mataʻutia e gaosia i ni faʻapitoa (faʻataʻitaʻiga, e-PTFE vascular grafts, patches). Aokai PTFE tuʻuina atu PTFE mea mataʻina e faʻaogaina e le au gaosi masini faʻagaioiga mo nei talosaga.
Gaosi Mea Fa'afoma'i & Fa'agaioiina Talosaga
O le mea lea e sili ona fa'aoga sa'o ai le lipine PTFE maualuga-vevela i lona fa'apipi'i.
1. Puipuiga o Mea Fa'amama
Metotia Fa'amama
PTFE Tape Galuega
Fa'atinoga
Ausa ta'avale (121-134°C)
Puipui fata ma puipui o potu; puipuia le pipii o fa'amaufa'ailoga / gaskets
Talitonu i ta'amilosaga maualuga o le vevela
EtO sterilization
Puipuiga o luga i le taimi o le faʻamaʻaina o kesi
Tete'e i vaila'au; leai se fa'aleagaina
Gamma irradiation
Puipuiga mo taimi pupuu (fa'alagolago ile fua)
Fa'atapula'a - va'ai le tala muamua i le fa'avevela fa'avevela
PTFE-fa'avae lipine fa'asagatau ta'amilosaga fa'amama masani e aofia ai le ausa autoclave, EtO, ma le tele o vaila'au fa'amalama.
2. Fa'amaufa'ailoga vevela
I le afifiina ma'i fa'afoma'i ma IV taga fa'amaufa'ailoga laina, o lo'o fa'apipi'i le lipine PTFE i luga o fa'avevela fa'amau ina ia ausia vave, fa'amaufa'ailoga mama e aunoa ma se fa'apipi'i fa'apipi'i i le mea ato. PTFE lipine ata e faatumauina le mautu ma le faatinoga vevela i luga o le -73°C i le 260°C, puipuia polymer fesiitaiga i le taimi o taga tapuni-.
3. Togafitiga Fa'asagaga o Mea Fa'a'a'upega
Fa'atatauga
Faamanuiaga
U'u meafaigāluega ufiufi
Anti-slip, uu ergonomic
Laina nofoaafi taiala
Smoother linear motion, fa'aitiitia le fa'atupuina o le pa'u
Insulation eletise mo meafaigaluega i totonu
Malosiaga dielectric, mautu vevela
Aokai PTFE tuʻuina atu PTFE maualuga-vevela lipine mo meafaigaluega afifiina faafomai ma sterilization fata puipuiga. O lo'o maua a matou lipine fa'atasi ma le fa'apipi'i fa'apipi'i silikoni, lea e fa'asagatau fa'asolosolo ta'amilosaga autoclave e aunoa ma ni mea fa'apipi'i.
Tulaga Fa'atonutonu mo Foma'i-Vaega PTFE
1. FDA 21 CFR 177.1550 – Fa'avae Tausi
FDA 21 CFR 177.1550 o le fa'avae tulafono a le US Food and Drug Administration mo resini fluoropolymer. O le tausisia e mautinoa ai le saogalemu o meafaitino a le PTFE mo le faʻaaogaina faifaipea i le faʻafesoʻotaʻi ma meaʻai - ma i le faʻaopoopoga, o se tulaga masani faʻasino mo le PTFE vasega faafomaʻi.
Fa'aeseesega taua: E le fa'atagaina e le FDA meafaitino; e faamaonia ai masini faafomai ua uma. A fa'ailoa mai e se tagata fa'atau oloa o le PTFE o le 'FDA fa'amaonia', e masani lava ona fa'auiga o mea e fa'atatau i le 21 CFR 177.1550 - o le mea moni o se tulaga fa'afeso'ota'i mea'ai-. Mo masini fa'afoma'i, o le fa'atagaga mulimuli e fa'alagolago i le tu'uina atu atoa e le kamupani gaosi masini ile FDA.
2. ISO 10993 – Su'ega Biocompatibility
Mo talosaga fa'afeso'ota'i sa'o ma'i, e tatau ona fa'ata'ita'i le PTFE ile ISO 10993 fa'asologa:
O mea a le PTFE e faʻataʻitaʻiina ina ia mautinoa e leai se oona o le sela, leai se lagona, ma leai ni faʻalavelave faʻaleagaina pe a faʻafesoʻotaʻi ma aano o le tagata.
Aotelega & Filifiliga Taiala
Afai o lau talosaga e aofia ai...
Filifili PTFE lipine?
Manatu taua
Fa'afeso'ota'i sa'o ma'i (fa'ato'aga)
E le pei o se lipine – fa'aaoga mea mata'utia PTFE
Manaomia le faamaoniga a le FDA; Su'ega ISO 10993 fa'atulafonoina
Puipuiga o meafaigaluega fa'amasima
✅ Ioe
Manaomia le PSA silikoni e mafai ona fa'asagatau ta'amilosaga ta'amilosaga ta'avale (121-134°C)
Fa'amaufa'ailoga vevela
✅ Ioe
PTFE lipine ata tifaga sili; fa'amaonia le fetaui lelei o le vevela
Fa'apipi'i luga o meafaigāluega ta'oto
✅ Ioe
Ia mautinoa le biocompatibility ole mea fa'apipi'i pe a mafai ona fa'afeso'ota'i ma'i
Puipuiga o masini su'esu'e / leai ni ma'i
✅ Ioe
Lava le lipine PTFE masani
I se aotelega , PTFE maualuga-vevela lipine tautua tolu tiers o talosaga faafomai. Mo talosaga fa'afoma'i autu (fa'afeso'ota'i tu'usa'o ma'i), e fa'aaogaina le PTFE o se mea mata'utia (e le o se mea fa'apipi'i) fa'atasi ai ma le fa'atagaga a le FDA ma le ISO 10993 su'ega biocompatibility. Mo le gaosiga o masini faʻafomaʻi ma le faʻaogaina - puipuiga o meafaigaluega faʻamaʻi, faʻamaufaʻailoga vevela, ma le faʻaogaina o mea faigaluega - PTFE tape e mafai ona faʻaoga saʻo, faʻatasi ai ma le PSA silicone fautuaina mo siosiomaga autoclave.
O le tausisia o tulafono faatonutonu e amata ile FDA 21 CFR 177.1550 mo le saogalemu o meafaitino, ae o le faamaoniga mulimuli o masini e manaʻomia ai le tuʻuina atu o le gaosiga. Mo talosaga fa'apitoa fa'afeso'ota'i ma'i, fa'amaonia i taimi uma su'ega biocompatibility i le oloa ua mae'a, ae le na'o le mea mata.
Manaomia lipine PTFE po'o mea mata'utia mo se talosaga faafoma'i? Aokai PTFE tu'uina atu fa'afoma'i-grade PTFE oloa. Fa'afeso'ota'i matou i au fa'amatalaga au talosaga, metotia fa'amama fa'amoemoe, ma mana'oga fa'atonutonu.
Afai e te fia iloa atili e uiga i le auiliiliga auiliili, faʻataʻitaʻiga faʻataʻitaʻiga, ma fofo faʻapitoa mo la tatou oloa atoa, e aofia ai le PTFE maualuga-vevela ie, PTFE maualuga-vevela lipine, PTFE maualuga-vevela fusipaʻu, fusi fusi masini fusipaʻu, tasi-itu PTFE ie, maualuga-vevela conveyor fusipaʻu ma maualuga-vevela ie faʻafesoʻotaʻi i matou:
Faʻalagolago i le filosofia o tomai faʻapitoa ma le faʻamaoni, matou te tuuto atu i le tuʻuina atu o fofo tasi-taofi ma auaunaga mafaufau mo tagata uma.
