Ekuhlinzweni kwe-craniomaxillofacial (CMF), ukunemba, ukuzinza, kanye ne-biocompatibility kubalulekile. A eklanywe kahleI-CMF self-drilling screw iphakethe linomthelela oqondile emiphumeleni yokuhlinzwa, linciphisa isikhathi sokusebenza, futhi lithuthukisa ukululama kwesiguli. Kodwa-ke, akuwona wonke amaphakethe ama-screw adalwe alingana. Ukuqinisekisa ukuthi ukhetha umkhiqizo ohlangabezana namazinga aphezulu okusebenza, cabangela lezi zindlela ezinhlanu ezibalulekile:
1. Izidingo Zezinto Ezibalulekile - Amandla Ne-Biocompatibility Factor
Isisekelo sanoma iyiphi i-CMF self-drilling screw pack ilele ekwakhiweni kwayo kwempahla. Izikulufu ze-CMF zekhwalithi ephezulu zivame ukukhiqizwa kusukela ku-Ti-6Al-4V titanium alloy. Leli banga le-titanium laziwa kabanzi emkhakheni wezokwelapha ngenxa yesilinganiso salo esiyingqayizivele samandla nesisindo, ukumelana nokugqwala, futhi, okubaluleke kakhulu, ukuhambisana kwayo okuhle kakhulu kwe-biocompatibility.
Uma kuqhathaniswa nensimbi engagqwali, i-Ti-6Al-4V ayinciphisi nje kuphela ubungozi bokungezwani nomzimba kodwa futhi ikhuthaza ukuhlanganiswa kwamathambo isikhathi eside. Ezinqubweni ze-CMF, lapho izikulufu zivame ukufakwa emathanjeni athambile e-cranial nasebusweni, lokhu kuvumelana kwe-biocompatibility kuqinisekisa ukusabela okuncishisiwe kokuvuvukala kanye nokuphulukiswa okuthuthukisiwe. Ngaso sonke isikhathi hlola izitifiketi zezinto ezibonakalayo ezivela kumkhiqizi ukuze uqinisekise izinga lengxubevange kanye nokuhambisana kwalo namazinga e-ASTM F136 noma ISO 5832-3.
2. I-Screw Size Range - Ukuzivumelanisa nezimo nokuguquguquka kokuhlinzwa
Iphakethe le-screw self-drilling ye-CMF esebenza kakhulu kufanele linikeze amadayamitha ayisikulufu ahlukahlukene nobude ukuze kuhlangatshezwane nezidingo zokuhlinza ezihlukene. Isibonelo, izikulufu ezimfishane (4–6 mm) zivame ukusetshenziswa ezindaweni ezacile ze-cortical bone, kuyilapho izikulufi ezinde (kufika ku-14 mm) zingase zidingeke kumathambo aqinile noma amacala okuvuselela ayinkimbinkimbi.
Ukuvumelana nezimo ekusikeni kwezikulufu kunciphisa isidingo semithombo eminingi yomkhiqizo futhi kunciphisa ukubambezeleka kokuhlinzwa. Iphakethe elikahle kufanele libhalwe ngokucacile ngezikhombisi zosayizi, okuvumela odokotela abahlinzayo ukuthi bakhethe isikulufu esifanele ngokushesha ngaphandle kokuphazamisa ukuhamba komsebenzi. Ukwengeza, idizayini yesikulufu kufanele iqinisekise ikhono lokuzibhoboza elingaguquki, linciphise isidingo sokumba ngaphambili ezimweni eziningi, okungagcina isikhathi esiyigugu ekamelweni lokusebenza.
3. Ukwelapha Okungaphezulu - Ukuthuthukisa Ukuhlanganiswa Kwethambo kanye nokusebenza
Ukuqedwa okungaphezulu kwezikulufu ze-CMF kudlala indima ebalulekile kukho kokubili ukusebenza komshini kanye nokusabela kwebhayoloji. Izikulufu ze-CMF zezinga eliphezulu zokuzibhoboza zivame ukufaka izindawo ezigcotshiwe noma ezipholishiwe.
I-anodization ikhulisa ukushuba kwe-oxide ye-surface, ithuthukisa ukumelana nokugqwala futhi ithuthukise i-osteointegration ngokwakha indawo esebenza nge-bioactive ekhuthaza ukunamathiselwa kweseli lethambo.
Ukucwebeza kunciphisa ukungahambi kahle kwe-microscopic, kunciphisa ukunamathela kwamagciwane futhi kwehlisa ingozi yokutheleleka kwangemva kokuhlinzwa.
Eminye imikhiqizo ethuthukisiwe ingase ihlanganise ukuqina kwendawo ukuze kube nokuzinza kwasekuqaleni kanye ne-anodization ye-biocompatibility yesikhathi eside. Lapho uhlola iphakethe lesikulufu, buyekeza ukucaciswa kokwelashwa okungaphezulu komkhiqizi kanye nanoma iyiphi idatha yokuhlola yomtholampilo etholakalayo.
4. Ukupakishwa Okuyinyumba - Ukuhambisana Namazinga Egumbi Lokusebenza
Ngisho nesikulufu sekhwalithi ephezulu sisengozini uma ukupakishwa kwaso kwehluleka ukuhlangabezana nezidingo ezingenalutho. Iphakethe le-screw self-drilling le-CMF leprimiyamu kufanele lilethwe ngamaphakeji avaliwe, angenalutho, futhi avuleke kalula aqondana nezimiso zegumbi lokuhlinza.
Bheka amaphekhi anezici:
Izithiyo eziyinyumba kabili zokuvikela okungeziwe
Amadethi okuphelelwa yisikhathi amakwe ngokucacile nezinombolo zenkatho ukuze kulandeleke
Amadizayini asebenziseka kalula avumela ukubuyiswa kwesikulufu ngokushesha ngaphandle kokwephula inqubo eyinyumba
Abanye abakhiqizi baphinde banikeze amathreyi oyinyumba asekulungele ukusetshenziswa ahlela izikulufu nezishayeli ngokulandelana okunengqondo, enze inqubo yokuhlinzwa ibe lula.
5. Ukuthobela Umthetho - CE, FDA, kanye nesitifiketi se-ISO 13485
Embonini yemishini yezokwelapha, izitifiketi zingaphezu kwamaphepha - ziwubufakazi bekhwalithi nokuphepha okungaguquki. Iphakethe elithenjwayo lokuzibhoboza le-CMF kufanele lihlangabezane namazinga aqashelwa umhlaba wonke afana nalawa:
Ukumakwa kwe-CE - Kuyadingeka ukuze kusatshalaliswe e-European Union, okuqinisekisa ukuhambisana ne-EU Medical Device Regulation (MDR).
Imvume ye-FDA - Iqinisekisa ukuthi umkhiqizo uhlangabezana nezidingo zokuphepha nokusebenza e-United States.
Isitifiketi se-ISO 13485 - Ikhombisa ukuthi uhlelo lokuphatha ikhwalithi lomkhiqizi lwenzelwe izisetshenziswa zezokwelapha.
Ukuthenga kubahlinzeki abaqinisekisiwe akugcini nje ngokuqinisekisa ukwethembeka komkhiqizo kodwa futhi kunciphisa izingozi ezingokomthetho nokuhambisana nezibhedlela nemitholampilo.
E-Shuangyang Medical, akuwona kuphela umphakeli kodwa futhi nomkhiqizi we-1.5 mm CMF self-drilling screw pack. Zakhiwe futhi zakhiqizwa endlini, izikulufu zethu zenziwe nge-premium Ti-6Al-4V ye-medical-grade titanium alloy futhi zakhiwe kusetshenziswa ubuchwepheshe obuthuthukisiwe be-Swiss TONRNOS CNC ngokunemba okukhethekile nokuvumelana. Ngokwelashwa kwendawo ene-anodized, izinketho zosayizi abaningi, ukupakishwa okuyinyumba, nokuhambisana ngokugcwele namazinga e-CE, FDA, kanye ne-ISO 13485, imikhiqizo yethu yakhelwe ukuhlangabezana nezidingo zokusebenza eziphezulu kakhulu zokuhlinzwa.
Ukubambisana nathi kusho ukusebenza ngqo nomthombo - ukuqinisekisa amanani ancintisanayo, ukuhlinzekwa okuzinzile, kanye nekhwalithi engayekethisi ngezidingo zakho zokuhlinzwa ze-CMF.
Isikhathi sokuthumela: Aug-11-2025