Hauv kev phais craniomaxillofacial (CMF), precision, stability, thiab biocompatibility yog qhov tseem ceeb. Ib tug zoo tsimCMF self-drilling ntsia hlau pob muaj qhov cuam tshuam ncaj qha rau qhov tshwm sim ntawm kev phais, txo lub sijhawm ua haujlwm, thiab txhim kho cov neeg mob rov zoo. Txawm li cas los xij, tsis yog txhua lub pob ntsia hlau tsim sib npaug. Txhawm rau xyuas kom koj xaiv cov khoom uas ua tau raws li cov qauv kev ua tau zoo tshaj plaws, xav txog tsib yam tseem ceeb no:
1. Cov Khoom Siv Khoom Siv - Lub Zog thiab Biocompatibility Factor
Lub hauv paus ntawm txhua CMF tus kheej-drilling ntsia hlau pob yog nyob rau hauv nws cov khoom muaj pes tsawg leeg. Zoo CMF screws feem ntau yog tsim los ntawm Ti-6Al-4V titanium alloy. Qib ntawm titanium no tau lees paub dav hauv kev kho mob rau nws qhov tshwj xeeb lub zog-rau-qhov hnyav piv, kev tiv thaiv corrosion, thiab, qhov tseem ceeb tshaj, nws zoo heev biocompatibility.
Piv nrog stainless hlau, Ti-6Al-4V tsis tsuas yog txo qhov kev pheej hmoo ntawm kev tsis haum tshuaj, tab sis kuj txhawb kev sib koom ua ke ntawm cov pob txha mus ntev. Hauv cov txheej txheem CMF, qhov twg cov ntsia hlau feem ntau muab tso rau hauv cov pob txha ntawm lub ntsej muag thiab lub ntsej muag, qhov biocompatibility no ua kom txo qis cov lus teb thiab kho kom zoo. Nco ntsoov xyuas cov ntaub ntawv pov thawj los ntawm cov chaw tsim khoom kom paub meej tias qib alloy thiab nws ua raws li ASTM F136 lossis ISO 5832-3 cov qauv.
2. Screw Size Range – Adaptability thiab Surgical Flexibility
Ib qho kev ua haujlwm siab CMF tus kheej-drilling ntsia hlau pob yuav tsum muaj ntau yam ntawm cov ntsia hlau taub thiab ntev kom haum raws li qhov xav tau kev phais sib txawv. Piv txwv li, cov ntsia hlau luv luv (4-6 hli) feem ntau yog siv rau hauv cov pob txha cortical nyias, thaum cov ntsia hlau ntev (txog 14 hli) yuav tsim nyog rau cov pob txha tuab lossis cov teeb meem rov ua dua tshiab.
Flexibility nyob rau hauv cov ntsia hlau sizing txo qhov yuav tsum tau rau ntau yam khoom qhov chaw thiab minimizes phais ncua. Ib pob zoo tagnrho yuav tsum tau sau meej meej nrog cov ntsuas qhov loj me, ua rau cov kws phais neeg xaiv cov ntsia hlau zoo sai yam tsis muaj kev cuam tshuam kev ua haujlwm. Tsis tas li ntawd, cov ntsia hlau tsim yuav tsum ua kom muaj peev xwm ua tau zoo ntawm tus kheej, txo qhov kev xav tau ntawm kev xyaum ua ntej hauv feem ntau, uas tuaj yeem txuag lub sijhawm muaj txiaj ntsig hauv chav ua haujlwm.
3. Kev Kho Hniav - Txhim kho pob txha sib koom ua ke thiab kev ua haujlwm zoo
Qhov saum npoo ntawm CMF screws plays lub luag haujlwm tseem ceeb hauv ob qho tib si kev ua haujlwm thiab cov lus teb lom neeg. High-qib CMF self-drilling ntsia hlau packs feem ntau feature anodized los yog polished nto.
Anodization nce saum npoo oxide thickness, txhim kho corrosion kuj thiab txhim kho osteointegration los ntawm kev tsim cov bioactive nto uas txhawb cov pob txha ntawm tes.
Polishing minimizes microscopic irregularities, txo cov kab mob adhesion thiab txo cov kev pheej hmoo ntawm tus kab mob tom qab phais.
Qee cov khoom lag luam siab heev tuaj yeem ua ke qhov chaw roughening rau thawj zaug stability nrog anodization rau lub sij hawm ntev biocompatibility. Thaum ntsuam xyuas lub pob ntsia hlau, tshuaj xyuas cov chaw tsim khoom cov kev kho mob saum npoo thiab cov ntaub ntawv kuaj mob muaj nyob.
4. Sterile Ntim - Ua raws li cov qauv kev ua haujlwm hauv chav ua haujlwm
Txawm tias cov ntsia hlau zoo tshaj plaws raug cuam tshuam yog tias nws lub ntim tsis ua raws li qhov yuav tsum tau ua kom tsis muaj menyuam. CMF tus kheej-drilling ntsia hlau pob yuav tsum tau muab xa mus rau hauv ib tus zuj zus kaw, tsis muaj menyuam, thiab qhib ntim yooj yim uas ua raws li cov txheej txheem hauv chav ua haujlwm.
Nrhiav cov pob khoom uas muaj xws li:
Ob chav sterile barriers rau kev tiv thaiv ntxiv
Qhia meej meej hnub tas sij hawm thiab ntau tus lej rau traceability
Cov neeg siv-phooj ywg tsim uas tso cai rau kev ceev cov ntsia hlau rov qab yam tsis tau rhuav tshem cov txheej txheem tsis muaj menyuam
Qee cov tuam txhab lag luam kuj tseem muab cov tais uas muaj menyuam tsis taus uas npaj cov ntsia hlau thiab cov tsav tsheb hauv ib qho kev sib tw, ua kom cov txheej txheem phais.
5. Kev Ua Raws Cai - CE, FDA, thiab ISO 13485 Daim Ntawv Pov Thawj
Hauv kev lag luam khoom siv kho mob, cov ntawv pov thawj muaj ntau dua li cov ntaub ntawv - lawv yog cov pov thawj ntawm kev ua tau zoo thiab kev nyab xeeb. Kev ntseeg siab CMF tus kheej-drilling ntsia hlau pob yuav tsum ua tau raws li cov qauv kev lees paub thoob ntiaj teb xws li:
CE kos npe - Yuav tsum tau muab faib rau hauv European Union, lees paub ua raws li EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR).
FDA clearance - Xyuas kom cov khoom ua tau raws li kev nyab xeeb thiab kev ua tau zoo hauv Tebchaws Meskas.
ISO 13485 daim ntawv pov thawj - Qhia tau tias cov chaw tsim khoom lag luam kev tswj hwm kev ua tau zoo yog tsim tshwj xeeb rau cov khoom siv kho mob.
Kev yuav khoom los ntawm cov neeg muab ntawv pov thawj tsis yog tsuas yog ua kom ntseeg tau cov khoom lag luam xwb tab sis kuj txo cov kev pheej hmoo raug cai thiab kev ua raws cai rau tsev kho mob thiab chaw kho mob.
Ntawm Shuangyang Medical, peb tsis yog tsuas yog tus neeg muag khoom tab sis kuj yog cov chaw tsim khoom ntawm 1.5 hli CMF tus kheej-drilling ntsia hlau pob. Tsim thiab tsim nyob rau hauv tsev, peb cov ntsia hlau yog tsim los ntawm hwm Ti-6Al-4V kev kho mob-qib titanium alloy thiab crafted siv advanced Swiss TONRNOS CNC tshuab rau tshwj xeeb precision thiab sib xws. Nrog rau kev kho deg anodized, ntau qhov kev xaiv loj, ntim tsis muaj menyuam, thiab ua raws li CE, FDA, thiab ISO 13485 cov qauv, peb cov khoom tsim los ua kom tau raws li qhov xav tau ntawm kev phais siab tshaj plaws.
Kev koom tes nrog peb txhais tau hais tias ua haujlwm ncaj qha nrog lub hauv paus - kom ntseeg tau tus nqi sib tw, khoom siv ruaj khov, thiab tsis muaj kev cuam tshuam zoo rau koj qhov kev xav tau ntawm CMF.
Post lub sij hawm: Aug-11-2025