Mu craniomaxillofacial (CMF) kuvhiyiwa, kunyatsojeka, kugadzikana, uye biocompatibility ndizvo zvakakosha. Yakagadzirwa zvakanakaCMF self-drilling screw pack ine simba rakananga pane zvakabuda pakuvhiya, inoderedza nguva yekushanda, uye inowedzera kupora kwemurwere. Nekudaro, haasi ese screw packs anogadzirwa akaenzana. Kuti uve nechokwadi chekuti wasarudza chigadzirwa chinosangana nepamusoro-soro maitiro, funga izvi zvishanu zvakakosha maitiro:
1. Zvinhu Zvinodiwa - Iyo Simba uye Biocompatibility Factor
Hwaro hwechero CMF yekuzviboora screw pack iri mukuumbwa kwayo kwezvinhu. Yepamusoro-mhando CMF screws inowanzo gadzirwa kubva kuTi-6Al-4V titanium alloy. Iri giredhi retitanium rinozivikanwa zvakanyanya mundima yekurapa nekuda kwesimba rayo-ku-huremu reshiyo, kuramba kwecorrosion, uye, kunyanya kukosha, kwayo kwakanakisa biocompatibility.
Kuenzaniswa nesimbi isina tsvina, Ti-6Al-4V haingoderedzi njodzi yekusagadzikana kwemuviri asiwo inosimudzira kwenguva refu yekubatana kwemapfupa. Mune CMF maitiro, uko screws anowanzo kuiswa muakatetepa cranial uye kumeso mapfupa, iyi biocompatibility inovimbisa kuderedzwa kwekuzvimba mhinduro uye kuwedzeredzwa kupora. Gara uchitarisa zvitupa kubva kumugadziri kuti asimbise giredhi realloy uye kutevedzera ASTM F136 kana ISO 5832-3 zviyero.
2. Screw Size Range - Kugadzirisa uye Kuvhiya Kuchinja
Iyo yepamusoro-inoshanda CMF yekuzviboorera screw pack inofanirwa kupa akasiyana masiruu madhayamita uye kureba kuti agadzirise zvakasiyana zvinodiwa zvekuvhiya. Semuenzaniso, mapfupi screws (4-6 mm) anowanzo shandiswa munzvimbo dzakatetepa dzecortical bone, nepo masikiru akareba (kusvika 14 mm) anogona kudikanwa kune gobvu bhonzo kana yakaoma reconstructive kesi.
Flexibility in screw sizing inoderedza kudiwa kweakawanda zvigadzirwa masosi uye inoderedza kunonoka kwekuvhiya. Paki yakakodzera inofanirwa kunyorwa zvakajeka nesaizi zviratidzo, zvichiita kuti vavhiyi vasarudze screw chaiyo nekukurumidza pasina kukanganisa mafambiro ebasa. Uye zvakare, iyo screw dhizaini inofanirwa kuve nechokwadi kuenderana kuzvidzora kugona, kuderedza kudiwa kwekutanga-kuchera muzviitiko zvakawanda, izvo zvinogona kuchengetedza yakakosha nguva mukamuri yekushandisa.
3. Kurapa Kwepamusoro - Kuvandudza Bone Kubatanidzwa uye Kuita
Iyo yekumusoro kupera kweCMF screws inoita basa rakakosha mune ese mekinika kuita uye biological mhinduro. Yepamusoro-giredhi CMF yekuzviboorera screw packs inowanzo ratidza anodized kana kukwenenzverwa nzvimbo.
Anodization inowedzera pamusoro oxide ukobvu, kunatsiridza corrosion kuramba uye kusimudzira osteointegration nekugadzira bioactive pamusoro inokurudzira bone sero kubatanidza.
Kuchenesa kunoderedza kusarongeka kwemicroscopic, kuderedza kunamatira kwebhakitiriya uye kuderedza njodzi yehutachiona hwepashure.
Zvimwe zvigadzirwa zvepamberi zvinogona kusanganisa kuomarara kwekutanga kugadzikana neanodization yenguva refu biocompatibility. Paunenge uchiongorora screw pack, ongorora mamiriro emugadziri ekurapa uye chero iripo data yekuongorora yekiriniki.
4. Sterile Packaging - Kuenderana neOperating Room Standards
Kunyangwe iyo yemhando yepamusoro-soro screw inokanganiswa kana kurongedza kwayo ikatadza kuzadzisa steril zvinodiwa. Yekutanga CMF yekuzviboorera screw pack inofanirwa kuunzwa mune imwe neimwe yakavharwa, isina kuchena, uye iri nyore-kuvhura-pakeji inofambirana nemapuroteni ekamuri yekushandisa.
Tsvaga mapaketi anoratidza:
Zvipingamupinyi zvakapetwa kaviri zvekudzivirira kwakawedzerwa
Mazuva ekupera kwenguva akajeka uye nhamba dzemijenya dzekutsvaga
Mushandisi-ane hushamwari madhizaini anobvumira kukurumidza kudzoreredza sikuruu pasina kutyora nzira isina hutachiona
Vamwe vagadziri vanopawo akagadzirira-kushandisa-asina kuchena matireyi anoronga screws uye madhiraivha munhevedzano inonzwisisika, kugadzirisa maitiro ekuvhiya.
5. Regulatory Compliance - CE, FDA, uye ISO 13485 Certification
Muindasitiri yemidziyo yekurapa, zvitupa zvinopfuura mapepa - iwo humbowo hwekuenderana kwemhando uye kuchengeteka. Iyo yakavimbika CMF yekuzviboora screw pack inofanirwa kusangana nemazinga anozivikanwa pasi rose akadai se:
Kumaka kweEC - Inodiwa kuti igovane muEuropean Union, ichisimbisa kutevedzera EU Medical Device Regulation (MDR).
FDA clearance - Inovimbisa kuti chigadzirwa chinosangana nekuchengetedza uye kuita zvinodiwa muUnited States.
ISO 13485 certification - Inoratidza kuti mugadziri wemhando yekutonga system yakanyatso kurongedzerwa kumidziyo yekurapa.
Kutenga kubva kuvatengesi vane zvitupa hakungovimbisi kuvimbika kwechigadzirwa chete asiwo kunoderedza njodzi dzepamutemo uye dzekuteedzera njodzi kuzvipatara nemakiriniki.
PaShuangyang Medical, isu hatisi chete mutengesi asiwo mugadziri we 1.5 mm CMF self-drilling screw pack. Yakagadzirwa uye inogadzirwa-mukati-mumba, masiruuru edu anogadzirwa kubva kuprimem Ti-6Al-4V yekurapa-giredhi titanium alloy uye akagadzirwa achishandisa advanced Swiss TONRNOS CNC tekinoroji yekunyatso hunyanzvi uye kuenderana. Neanodized pamusoro kurapwa, akawanda saizi sarudzo, sterile kurongedza, uye kutevedzera kuzere neEC, FDA, uye ISO 13485 zviyero, zvigadzirwa zvedu zvakavakwa kuti zvisangane nepamusoro pekuita kwekuvhiya zvinodiwa.
Kudyidzana nesu kunoreva kushanda zvakananga nekwakabva - kuve nechokwadi chemakwikwi emitengo, yakagadzikana kuwanikwa, uye isingachinjiki mhando yezvinodiwa zvekuvhiya zveCMF.
Nguva yekutumira: Aug-11-2025