1. ASTM F136 yog dab tsi?
ASTM F136 yog tus qauv tso cai tsim los ntawm ASTM International, nrog rau tag nrho cov npe Standard Specification rau Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Cov qauv no yog tsim thiab tswj los ntawm Subcommittee F04.12 raws li ASTM Pawg F04 ntawm Kev Kho Mob thiab Cov Khoom Siv Kho Mob thiab Cov Khoom Siv. Nws qhia txog cov kev cai tshuaj, txhua yam, thiab metallurgical rau wrought annealed Ti‑6Al-4V ELI alloy siv hauv kev tsim cov khoom siv phais.
ASTM F136 npog cov ntaub ntawv khoom xws li sawb, ntawv, phaj, bar, forging Tshuag, thiab hlau. Ntawm cov no, titanium bar yog ib qho ntawm cov ntaub ntawv tseem ceeb tshaj plaws, nrog txoj kab uas hla feem ntau yog li ntawm 3.0 hli mus rau 200 hli. Raws li cov khoom siv tseem ceeb rau cov khoom siv kho mob implantable, ASTM F136 titanium bar yog siv dav hauv cov leeg txha caj qaum, kev sib koom tes, kev cog hniav, thiab cov pob txha phaj / ntsia hlau sab hauv kho, ntawm ntau yam khoom siv kho mob.
Hauv kev lag luam khoom siv kho mob, Ti‑6Al-4V ELI feem ntau hu ua Titanium Alloy Qib 23 lossis TC4 ELI, thiab suav tias yog "tus qauv kub" ntawm cov titanium alloys kho mob.
2. "ELI" txhais li cas?
"ELI" stands rau Ntxiv Tsawg Interstitial. Piv nrog cov paTi‑6Al-4V (Qib 5), ELI version imposes ntau nruj tswj ntawm interstitial ntsiab xws li carbon, oxygen, nitrogen, thiab hydrogen.
Siv cov ntaub ntawv luam tawm los ntawm Straumann ua piv txwv, cov kev cai tshuaj muaj pes tsawg leeg rau Ti‑6Al-4V ELI yog raws li hauv qab no:
| Lub ntsiab | Cov ntsiab lus (wt%) |
| Titanium (Ti) | 88.5 – 91 |
| Aluminium (Al) | 5.5 – 6.5 |
| Vanadium (V) | 3.5 – 4.5 |
| Hlau (Fe) | Tsawg dua lossis sib npaug li 0.25 |
| Cov pa oxygen (O) | Tsawg dua lossis sib npaug li 0.13 |
| Cov pa roj carbon (C) | Tsawg dua lossis sib npaug li 0.08 |
| Nitrogen (N) | Tsawg dua los yog sib npaug li 0.05 |
| Hydrogen (H) | Tsawg dua lossis sib npaug li 0.012 |
Qhov kev tswj hwm nruj ntawm cov ntsiab lus tsis huv no ua rau ELI qib siab dua pob txha tawv thiab qis qis qis qis kev loj hlob piv rau tus qauv Ti‑6Al-4V. Cov ntsiab lus luv interstitial kuj ua rau muaj kev sib txuam ntau dua microstructure, pab txhawb kev ua haujlwm zoo dua.
3. Vim li cas Ti‑6Al-4V ELI yog cov khoom siv zoo tshaj plaws rau cov khoom siv kho mob?
3.1 Zoo heev biocompatibility
Thaum titanium alloy raug rau huab cua los yog lub cev kua, nws spontaneously tsim ib tug ruaj khov, nruam, thiab ntom oxide zaj duab xis (tsuas yog TiO₂) ntawm nws nto. Cov oxide txheej no muab kev tiv thaiv corrosion siab nyob rau hauv ib puag ncig physiological, thiab cov khoom elicits zoo li tsis muaj kev phiv cov ntaub so ntswg.
Ti‑6Al-4V ELI tau dhau los ntawm tag nrho cov txheej txheem ISO 10993-1 kev ntsuam xyuas kev nyab xeeb, nrog rau qib cytotoxicity tsawg dua lossis sib npaug li 1. Vim li no, nws tau siv ntau yam kev cog hniav ruaj khov - los ntawm cov pob qij txha thiab cov leeg txha caj qaum mus rau kev cog hniav thiab cov khoom siv plawv.
Tsis tas li ntawd, Ti‑6Al-4V ELI yog MRI-tshaj - nws tsis yog hlau nplaum thiab tuaj yeem siv nyab xeeb thaum kuaj xyuas magnetic resonance.
3.2 Zoo tagnrho txhua yam khoom
Tej yam khoom siv ntawm Ti-6Al-4V ELI yog:
| Khoom | Tus nqi |
| Tensile zog | Ntau dua lossis sib npaug rau 860 MPa |
| Yield zog (0.2% offset) | Ntau dua lossis sib npaug li 795 MPa |
| Elastic modulus | Qhov siab tshaj plaws ntawm qhov siab tshaj plaws yog 110 GPa |
| Elongation | Ntau dua lossis sib npaug li 10% |
| Qhov ntom | 4.42 - 4.43 g / cm³ |
Siab tshwj xeeb muaj zog: Titanium alloy tsuas muaj li ntawm 60% qhov ntom ntawm cov hlau, tsis tau nws lub zog deb tshaj li cov ntshiab titanium. Qhov no txhais tau hais tias kev cog qoob loo ua los ntawm Ti‑6Al-4V ELI tuaj yeem ua nyias thiab sib dua thaum tuav lub zog txaus.
Elastic modulus ze rau pob txha: Txawm hais tias lub modulus ntawm titanium (≈110 GPa) tseem siab dua li ntawm tib neeg cov pob txha cortical (10-30 GPa), nws tseem qis dua cov hlau tsis muaj steel (≈200 GPa) thiab cobalt-chromium alloys (≈230 GPa). Qhov no yuav pab txo qhovtiv thaiv kev ntxhov siabeffect - qhov chaw cog qoob loo nqa ntau dhau, ua rau atrophy ntawm cov pob txha nyob ib puag ncig.
Superior qaug zog kuj: Kev cog hniav hauv lub cev (xws li cov pob qij txha thiab cov leeg txha caj qaum) tau txais ntau lab lub voj voog thauj khoom txhua hnub. Ti‑6Al-4V ELI, nrog rau nws lub zog qaug zog zoo heev thiab ua rau kev puas tsuaj, tuaj yeem tswj xyuas kev ncaj ncees rau lub sijhawm ntev. Cov kev tshawb fawb tau pom tias Ti‑6Al-4V ELI tsim los ntawm laser hmoov txaj fusion tuaj yeem ua tiav lub neej qaug zog ntawm 10⁶-10⁷ cycles ntawm kev ntxhov siab amplitudes ntawm 300-400 MPa.
3.3 Zoo corrosion kuj
Ib puag ncig sab hauv ntawm tib neeg lub cev yog sov, noo, thiab muaj ntau yam electrolytes thiab proteins. Qhov ntom ntom oxide zaj duab xis ntawm Ti‑6Al-4V ELI muab ib qhotsis tshua muaj corrosion tus nqinyob rau hauv no complex physiological ib puag ncig - tsawg tshaj li 0.001 mm / xyoo nyob rau hauv simulated lub cev kua, uas tsis muaj txawv txav ntawm cov hlau ions. Qhov no ua kom muaj kev ruaj ntseg ntev thiab kev nyab xeeb ntawm kev cog qoob loo thaum nws ua haujlwm hauv lub cev.
4. Kev siv hauv kev kho hniav prosthetics
Orthopedic implants
Ti‑6Al-4V ELI yog cov khoom siv tseem ceeb rau kev cog hniav orthopedic thiab yog siv dav hauv kev tsim cov pob qij txha pob qij txha, pob qij txha hauv caug, thiab cov pob qij txha intervertebral.
Artificial pob qij txha: Cov tibial cov khoom ntawm lub hauv caug prostheses feem ntau yog ua los ntawm wrought Ti‑6Al-4V ELI alloy ua raws li ASTM F136. Lub hauv caug kho lub hauv caug tau pom zoo rau kev ua lag luam los ntawm National Medical Products Administration (NMPA).
Spinal fixation systems: Pedicle screws, txuas rods, thiab lwm yam khoom feem ntau yog tsim los ntawm Ti‑6Al-4V ELI. ASTM F136 titanium bar-ua pedicle screws nthuav tawmme me residual deformation thiab zoo heev torsional kev ua tau zoo, nrog ruaj khov torsion kaum siab tshaj 180 degree.
Pob txha daim hlau thiab screws: Ntau yam kev txhim kho kev puas tsuaj (pob txha daim hlau, pob txha taub hau) feem ntau siv Ti‑6Al-4V ELI.
Intramedullary ntsia thawv systems: Cov khoom lag luam los ntawm cov tuam txhab xws li Stryker siv Ti‑6Al-4V ELI (ASTM F136) rau cov ntsia hlau, lub kaus mom kawg, compression screws, thiab lwm yam khoom.
Kev kho hniav implants
Kev cog hniav thiab lawv cov abutments yog lwm qhov tseem ceeb ntawm daim ntawv thov rau Ti‑6Al-4V ELI. Qee lub tshuab cog yog tsim los ntawm Ti‑6Al-4V ELI ua raws li ASTM F136, thiab cov chaw cog khoom feem ntau raug kho (xws li, los ntawm sandblasting thiab acid-etching, SLA) los txhawb osseointegration.
Maxillofacial thiab craniomaxillofacial reconstruction
Raws li preoperative nyias-slice CT cov ntaub ntawv reconstruction, tus kheej mandibular reconstruction implants tsim los ntawm kev kho mob-qib Ti‑6Al-4V ELI hmoov los ntawmxaiv laser meltingtau siv tshuaj kho mob. Cov khoom siv no nruj me ntsis siv Ti‑6Al-4V ELI alloy uas ua tau raws li qhov yuav tsum tau muaj ntawm GB / T 13810 thiab ASTM F136 rau kev cog hniav.
Cov hlab plawv thiab lwm yam khoom siv
Titanium alloys kuj tseem siv rau hauvArtificial plawv li qub, pacemakers, thiab lwm yam kab mob plawv. Ti‑6Al-4V ELI kuj tseem siv tau rau cov khoom siv hluav taws xob.
5. Los ntawm titanium bar mus rau cov cuab yeej kho mob: kev ua thiab kev tsim khoom
Melting thiab forging
Kev tsim khoom ntawm ASTM F136 titanium bar pib nrog cov txheej txheem melting zoo. Feem ntau, cov txheej txheem ob-melt ntawm Nqus Arc Remelting (VAR) + Electron Beam Cold Hearth Melting (EBCHM) yog siv, nrog nruj tswj cov ntsiab lus oxygen tsawg dua lossis sib npaug li 0.15%.
Cov txheej txheem forging yog ua nyob rau hauv ob theem: -theem cheeb tsam (950-1000 degree) cogging kom kho cov nplej, ua raws li + dual-theem cheeb tsam (850-900 degree) precision forging rau ze-net zoo, nrog grain loj tswj rau ASTM 5 los yog finer.
Kev kho cua sov
Cov txheej txheem duplex annealing yog siv: 950℃× 1 h / cua txias + 550℃× 4 h / cua txias, txhawm rau tshem tawm cov kev ntxhov siab, txhim kho microstructural uniformity, thiab ua tiav cov khoom xav tau.
Precision machining
Cov chaw nyuaj yog machined siv 5-axis CNC tshuab cuab yeej, nrog rau kev tswj kom tsawg dua los yog sib npaug rau ± 0.02 hli. CNC sib tsoo tuaj yeem ua tiav kev kho mob-qib precision nrog txoj kab uas hla kam rau ua tsawg dua lossis sib npaug rau ± 0.01 hli.
Additive manufacturing (3D luam ntawv)
Tsim cov qauv ntxeem tau hauv titanium alloys ntawm 3D luam ntawv yog ib qho tseem ceeb tsis ntev los no kev txhim kho hauv cov khoom siv kho mob. Siv Electron Beam Melting (EBM) lossis Selective Laser Melting (SLM) thev naus laus zis, nws muaj peev xwm tsim cov titanium porous implants nrog porosity ntawm 70% -80%. Xws li cov qauv ntxeem tau pab daws cov teeb meem cuam tshuam nrog cov pa wrought Ti‑6Al-4V ELI, xws li kev tiv thaiv kev ntxhov siab vim muaj cov qauv elastic siab thiab tsis txaus osseointegration vim bio-inertness.
Kev kho deg thiab sterilization
Implant nto feem ntau yog sandblasted (nrog Al₂O₃ hais) los yog anodised (nto roughness Ra=1-3 μm) los txhawb cov pob txha ingrowth. Cov khoom kawg yog lub tshuab nqus tsev kaw tom qab gamma irradiation sterilization (25-40 kGy).
6. Cov ntsiab lus
ASTM F136 / Ti‑6Al-4V ELI titanium bar tau dhau los ua cov khoom siv rau kev lag luam khoom siv kho mob vim tias nws ua tiav qhov sib npaug ntawm biocompatibility, kev ua haujlwm txhua yam, thiab kev ua tiav.
Qhov ntxiv-tsawg interstitial element tswj muab superior puas toughness thiab qaug zog kuj piv nrog cov qauv titanium alloys. Nws zoo heev corrosion kuj thiab biocompatibility ua kom lub sij hawm ntev stability nyob rau hauv lub complex ib puag ncig ntawm tib neeg lub cev, thaum nws nruab nrab elastic modulus pab txo kev nyuaj siab shielding thiab tiv thaiv cov pob txha ib puag ncig.
Los ntawm cov pob qij txha pob qij txha, pob qij txha hauv caug, thiab cov leeg txha caj qaum mus rau kev cog hniav thiab kho maxillofacial reconstruction implants, ASTM F136 titanium bar underpins precision manufacturing ntawm niaj hnub kho mob cov cuab yeej. Nrog rau kev txhim kho txuas ntxiv ntawm kev tsim khoom siv thev naus laus zis, daim ntawv thov ntawm Ti-6Al-4V ELI hauv cov txheej txheem porous cog tau nthuav dav ntxiv. Rau cov chaw tsim khoom siv kho mob thiab cov kws kho mob ib yam nkaus, xaiv Ti‑6Al-4V ELI uas ua tau raws li ASTM F136 txhais tau tias xaiv cov khoom txhawb nqa los ntawm ntau xyoo ntawm kev soj ntsuam kev lees paub thiab cov qauv thoob ntiaj teb meej - kev lees paub ntawm kev nyab xeeb thiab kev ntseeg tau.
