A cikin aikin tiyata na craniomaxillofacial (CMF), daidaito, kwanciyar hankali, da daidaituwar halittu sune mahimmanci. Kyakkyawan tsarawaCMF kai dunƙule hakowa fakitin yana da tasiri kai tsaye akan sakamakon tiyata, yana rage lokacin aiki, kuma yana haɓaka farfadowar haƙuri. Koyaya, ba duk fakitin dunƙule ba daidai suke ba. Don tabbatar da cewa kun zaɓi samfurin da ya dace da mafi girman ƙa'idodin aiki, la'akari da waɗannan mahimman ma'auni guda biyar:
1. Abubuwan Bukatun Material - Ƙarfi da Ƙarfafa Halitta
Tushen kowane fakitin dunƙule haƙon kai na CMF ya ta'allaka ne a cikin abun da ke ciki. Babban ingancin CMF sukurori ana yawanci kerarre daga Ti-6Al-4V titanium gami. Wannan sa na titanium an san shi sosai a fagen likitanci don ƙaƙƙarfan ƙarfin-zuwa-nauyi rabonsa, juriya na lalata, kuma, mafi mahimmanci, kyakkyawan yanayin rayuwa.
Idan aka kwatanta da bakin karfe, Ti-6Al-4V ba kawai yana rage haɗarin rashin lafiyar jiki ba amma yana inganta haɗin kai na tsawon lokaci. A cikin hanyoyin CMF, inda ake sanya sukurori sau da yawa a cikin ƙasusuwan cranial da kasusuwan fuska, wannan haɓakar ƙwayoyin cuta yana tabbatar da rage martanin kumburi da haɓaka warkarwa. Koyaushe bincika takaddun shaida daga masana'anta don tabbatar da ƙimar gami da bin ka'idodin ASTM F136 ko ISO 5832-3.
2. Matsakaicin Girman Rage - Daidaituwa da Sauƙaƙewar tiyata
Babban fakitin dunƙule haƙon kai na CMF ya kamata ya ba da diamita iri-iri da tsayi don ɗaukar buƙatun tiyata daban-daban. Misali, ana amfani da guntun sukurori (4-6 mm) sau da yawa a cikin wuraren kasusuwa na bakin ciki, yayin da dogon sukurori (har zuwa mm 14) na iya zama dole don kauri mai kauri ko hadaddun lamurra na sake ginawa.
Sassauci a cikin screw screw yana rage buƙatar tushen samfuri da yawa kuma yana rage jinkirin tiyata. Yakamata a sanya madaidaicin fakitin alama a fili tare da alamun girman, ba da damar likitocin fiɗa don zaɓar madaidaicin dunƙule cikin sauri ba tare da rushe aikin ba. Bugu da ƙari, ƙirar ƙira ya kamata ya tabbatar da daidaitaccen ikon hakowa kai tsaye, rage buƙatar hakowa a mafi yawan lokuta, wanda zai iya adana lokaci mai daraja a cikin ɗakin aiki.
3. Maganin Sama - Haɓaka Haɗin Kashi da Ayyuka
Ƙarshen saman na CMF sukurori yana taka muhimmiyar rawa a cikin aikin injiniya da amsawar halittu. Fakitin dunƙule haƙon kai na CMF mai girma sau da yawa suna nuna filaye masu ƙyalli ko goge.
Anodization yana ƙara kauri na oxide, inganta juriya na lalata da haɓaka osteointegration ta hanyar ƙirƙirar farfajiyar bioactive wanda ke ƙarfafa haɗin haɗin kashi.
Polishing yana rage rashin daidaituwa a cikin ƙananan ƙwayoyin cuta, rage mannewar ƙwayoyin cuta da rage haɗarin kamuwa da cuta bayan tiyata.
Wasu samfuran ci-gaba na iya haɗawa da jujjuyawar ƙasa don kwanciyar hankali na farko tare da anodization don daidaituwar rayuwa na dogon lokaci. A lokacin da ake kimanta fakitin dunƙule, bitar ƙayyadaddun jiyya na saman masana'anta da duk wani bayanan gwajin asibiti da ke akwai.
4. Bakararre Marufi - Yarda da Ka'idodin Dakin Aiki
Ko da mafi ingancin dunƙule yana da matsala idan marufinsa ya gaza cika buƙatun bakararre. Ya kamata a isar da fakitin dunƙule-ƙulle mai ƙima na CMF a cikin ɗaiɗaikun marufi, bakararre, da sauƙin buɗewa wanda ya dace da ka'idojin ɗakin aiki.
Nemo fakiti masu fasali:
Shingayen bakararre sau biyu don ƙarin kariya
Ƙayyadaddun ranakun ƙarewa da lambobi don ganowa
Zane-zane na abokantaka na mai amfani waɗanda ke ba da izinin maidowa da sauri ba tare da karya dabarar bakararre ba
Wasu masana'antun kuma suna ba da faranti maras kyau waɗanda ke tsara sukurori da direbobi a cikin tsari mai ma'ana, suna daidaita tsarin tiyata.
5. Yarda da Ka'idoji - CE, FDA, da ISO 13485 Takaddun shaida
A cikin masana'antar na'urorin likitanci, takaddun shaida sun fi aikin takarda - su ne tabbacin daidaiton inganci da aminci. Amintaccen fakitin dunƙule haƙon kai na CMF yakamata ya dace da ƙa'idodi na duniya kamar:
Alamar CE - Ana buƙata don rarrabawa a cikin Tarayyar Turai, yana tabbatar da bin ka'idodin Na'urar Likitan EU (MDR).
Amincewa da FDA - Yana tabbatar da samfurin ya cika aminci da buƙatun aiki a cikin Amurka.
TS EN ISO 13485 Takaddun shaida - Yana nuna cewa tsarin sarrafa ingancin masana'anta an keɓance shi musamman don na'urorin likita.
Saye daga ƙwararrun masu kaya ba wai kawai yana tabbatar da amincin samfur ba amma kuma yana rage haɗarin doka da yarda ga asibitoci da asibitoci.
A Shuangyang Medical, mu ba kawai masu samar da kayayyaki ba ne har ma da ƙera 1.5 mm CMF fakitin hakowa kai tsaye. An ƙera su kuma an samar da su a cikin gida, an yi sukurorin mu daga ƙirar Ti-6Al-4V na kayan aikin likitanci kuma an ƙera su ta amfani da fasahar Switzerland TONRNOS CNC ta ci gaba don daidaito na musamman da daidaito. Tare da anodized surface jiyya, mahara size zažužžukan, bakararre marufi, da kuma cikakken yarda da CE, FDA, da kuma ISO 13485 matsayin, mu kayayyakin da aka gina don saduwa da mafi girma aikin tiyata.
Haɗin kai tare da mu yana nufin yin aiki kai tsaye tare da tushen - tabbatar da farashin gasa, ingantaccen wadata, da ingantacciyar ƙima don buƙatun ku na tiyata na CMF.
Lokacin aikawa: Agusta-11-2025