Mu opaleshoni ya craniomaxillofacial (CMF), kulondola, kukhazikika, ndi kuyanjana kwazinthu ndizofunikira kwambiri. Wopangidwa bwinoCMF self-bowola screw paketi imakhudza mwachindunji zotsatira za opaleshoni, imachepetsa nthawi yogwiritsira ntchito, komanso imathandizira kuchira kwa odwala. Komabe, si ma screw paketi onse amapangidwa mofanana. Kuti muwonetsetse kuti mwasankha chinthu chomwe chikukwaniritsa magwiridwe antchito apamwamba kwambiri, lingalirani izi:
1. Zofunika Zakuthupi - Mphamvu ndi Biocompatibility Factor
Maziko a paketi iliyonse ya CMF yodzibowola yokha ili pamapangidwe ake. Zomangira zapamwamba za CMF nthawi zambiri zimapangidwa kuchokera ku Ti-6Al-4V titanium alloy. Titaniyamuyi imadziwika kwambiri m'zachipatala chifukwa cha mphamvu zake zolemetsa, kukana dzimbiri, komanso, chofunikira kwambiri, kuyanjana kwake ndi biocompatibility.
Poyerekeza ndi zitsulo zosapanga dzimbiri, Ti-6Al-4V sikuti imangochepetsa chiopsezo cha matupi awo sagwirizana komanso imalimbikitsa kuphatikiza mafupa kwa nthawi yayitali. M'machitidwe a CMF, pomwe zomangira nthawi zambiri zimayikidwa m'mafupa akhungu komanso amaso, biocompatibility iyi imatsimikizira kuyankha kotupa komanso kuchiritsa bwino. Nthawi zonse yang'anani satifiketi zakuthupi kuchokera kwa wopanga kuti mutsimikizire kalasi ya alloy ndikutsatira kwake ASTM F136 kapena ISO 5832-3 miyezo.
2. Screw Size Range - Kusinthasintha ndi Kusinthasintha Kwa Opaleshoni
Paketi yodzibowola ya CMF yochita bwino kwambiri iyenera kupereka masikhwala osiyanasiyana ndi utali wokwanira kukwaniritsa zosowa zosiyanasiyana za opaleshoni. Mwachitsanzo, zomangira zazifupi (4-6 mm) nthawi zambiri zimagwiritsidwa ntchito m'mafupa opyapyala a kortical, pomwe zomangira zazitali (mpaka 14 mm) zitha kukhala zofunikira pamafupa okhuthala kapena zovuta zomanganso.
Kusinthasintha kwa screw sizing kumachepetsa kufunika kwa zinthu zingapo komanso kumachepetsa kuchedwa kwa maopaleshoni. Phukusi loyenera liyenera kulembedwa momveka bwino ndi zizindikiro za kukula, zomwe zimathandiza maopaleshoni kusankha wononga yoyenera mwachangu popanda kusokoneza kayendedwe ka ntchito. Kuphatikiza apo, mapangidwe a screw ayenera kuonetsetsa kuti azidzibowola mosasinthasintha, kuchepetsa kufunika koboola nthawi zambiri, zomwe zingapulumutse nthawi yamtengo wapatali m'chipinda chogwirira ntchito.
3. Chithandizo cha Pamwamba - Kupititsa patsogolo Kugwirizana kwa Mafupa ndi Kuchita
Kumapeto kwa zomangira za CMF kumagwira ntchito yofunika kwambiri pamakina komanso kuyankha kwachilengedwe. Mapaketi odzibowola apamwamba a CMF nthawi zambiri amakhala ndi malo opukutidwa kapena opukutidwa.
Anodization imawonjezera makulidwe a oxide pamtunda, kumathandizira kukana kwa dzimbiri ndikukulitsa kukhazikika kwa osteointegration popanga malo okhala ndi bioactive omwe amalimbikitsa kulumikizidwa kwa cell ya mafupa.
Kupukuta kumachepetsa kusakhazikika kwapang'onopang'ono, kumachepetsa kumatira kwa bakiteriya ndikuchepetsa chiopsezo chotenga matenda pambuyo pa opaleshoni.
Zogulitsa zina zapamwamba zimatha kuphatikiza kuwungutsa kwapamtunda kuti kukhazikika koyambirira ndi anodization kwa biocompatibility yayitali. Mukawunika wononga paketi, yang'ananinso momwe wopanga amapangira mankhwala ndi zina zilizonse zoyezetsa zachipatala.
4. Wosabala Packaging - Kutsatira Miyezo ya Malo Ogwirira Ntchito
Ngakhale zomangira zapamwamba kwambiri zimasokonekera ngati zoyika zake zikulephera kukwaniritsa zofunikira. Phukusi la CMF lodzibowola lodzibowola lofunika kwambiri liyenera kuperekedwa m'mapaketi osindikizidwa, osabala, komanso osavuta kutsegula omwe amagwirizana ndi ma protocol opangira opaleshoni.
Fufuzani mapaketi omwe ali ndi:
Zotchinga ziwiri zosabala zachitetezo chowonjezera
Madeti otha ntchito ndi odziwika bwino komanso manambala agawo kuti mufufuze
Mapangidwe osavuta kugwiritsa ntchito omwe amalola kubweza wononga mwachangu popanda kuphwanya njira yosabala
Opanga ena amaperekanso ma tray okonzeka kugwiritsa ntchito osabala omwe amalinganiza zomangira ndi madalaivala motsatana bwino, kuwongolera njira ya opaleshoni.
5. Kutsatira Malamulo - CE, FDA, ndi ISO 13485 Certification
M'makampani opanga zida zamankhwala, ziphaso ndizochulukirapo kuposa zolemba - ndi umboni wokhazikika komanso chitetezo. Paketi yodalirika yodzibowola ya CMF iyenera kukwaniritsa miyezo yodziwika padziko lonse lapansi monga:
Chizindikiro cha CE - Chofunikira kuti chigawidwe ku European Union, kutsimikizira kutsatira EU Medical Device Regulation (MDR).
Chilolezo cha FDA - Chimatsimikizira kuti malondawo akukwaniritsa zofunikira zachitetezo ndi magwiridwe antchito ku United States.
Chitsimikizo cha ISO 13485 - Imawonetsa kuti kasamalidwe kabwino ka opanga amapangidwira zida zamankhwala.
Kugula kuchokera kwa ogulitsa ovomerezeka sikungotsimikizira kudalirika kwa mankhwala komanso kumachepetsa ngozi zalamulo ndi kutsata zipatala ndi zipatala.
Ku Shuangyang Medical, ife sitiri okha ogulitsa komanso opanga 1.5 mm CMF self-bowola screw paketi. Zopangidwa ndi kupangidwa m'nyumba, zomangira zathu zimapangidwa kuchokera ku Ti-6Al-4V wamtengo wapatali wa titaniyamu alloy ndipo amapangidwa pogwiritsa ntchito luso lapamwamba la Swiss TONRNOS CNC kuti likhale lolondola komanso losasinthasintha. Ndi chithandizo chapamwamba cha anodized, zosankha zamitundu ingapo, zoyikapo zosabala, komanso kutsata miyezo ya CE, FDA, ndi ISO 13485, zogulitsa zathu zimamangidwa kuti zikwaniritse zofunikira kwambiri pakupangira opaleshoni.
Kugwirizana nafe kumatanthauza kugwira ntchito mwachindunji ndi gwero - kuwonetsetsa kuti mitengo yamtengo wapatali, yokhazikika, komanso mtundu wosasunthika pazosowa zanu za opaleshoni ya CMF.
Nthawi yotumiza: Aug-11-2025