Kwi-craniomaxillofacial (CMF) utyando, ukuchaneka, ukuzinza, kunye ne-biocompatibility zibalulekile. A eyilwe kakuhleI-CMF self-drilling screw ipakethe inempembelelo ngqo kwiziphumo zotyando, inciphisa ixesha lokusebenza, kwaye iphucula ukubuyiswa kwesigulane. Nangona kunjalo, ayizizo zonke iipakethe ze-screw ezenziwe ngokulinganayo. Ukuqinisekisa ukuba ukhetha imveliso ehlangabezana neyona migangatho iphezulu yokusebenza, qwalasela ezi ndlela zintlanu zibalulekileyo:
1. IiMfuno zezinto eziphathekayo - Amandla kunye ne-Biocompatibility Factor
Isiseko sayo nayiphi na i-CMF self-drilling screw pack ilele ekubunjweni kwayo kwezinto. Izikrufu zeCMF ezikumgangatho ophezulu ziqhele ukwenziwa kwi-Ti-6Al-4V titanium alloy. Eli bakala le-titanium lamkelwa ngokubanzi kwicandelo lezonyango ngenxa yomlinganiselo walo ongaqhelekanga wobunzima bobunzima, ukunganyangeki kwe-corrosion, kwaye, okona kubaluleke kakhulu, ukuhambelana kwayo okugqwesileyo kwe-biocompatibility.
Xa kuthelekiswa nensimbi engenasici, i-Ti-6Al-4V ayinciphisi kuphela umngcipheko wokuchasana nomzimba kodwa ikhuthaza ukuhlanganiswa kwamathambo ixesha elide. Kwiinkqubo ze-CMF, apho izikrufu zihlala zibekwe kwi-cranial ethambileyo kunye namathambo obuso, le biocompatibility iqinisekisa impendulo encitshisiweyo yokuvuvukala kunye nokuphilisa okuphuculweyo. Soloko ujonga izatifikethi zemathiriyeli ezivela kumvelisi ukuqinisekisa ibakala lengxubevange kunye nokuthotyelwa kwayo nemigangatho ye-ASTM F136 okanye ISO 5832-3.
2. I-Screw Size Range - Ukuguquguquka kunye nokuguquguquka koCando
Ipakethe ye-screw ye-CMF esebenza ngokuphezulu kufuneka inikezele ngeendidi ze-screw diameters kunye nobude ukulungiselela iimfuno ezahlukeneyo zotyando. Umzekelo, izikrufu ezimfutshane (4-6 mm) zihlala zisetyenziswa kwiindawo ezibhityileyo ze-cortical bone, ngelixa izikrufu ezinde (ukuya kuthi ga kwi-14 mm) zinokuba yimfuneko kumathambo ashinyeneyo okanye amatyala okuvuselela anzima.
Ukuguquguquka kwisijiva sokulinganisa kunciphisa imfuno yemithombo yemveliso emininzi kwaye kunciphisa ukulibaziseka kotyando. Ipakethi efanelekileyo kufuneka ibhalwe ngokucacileyo ngezalathi zobungakanani, ivumela oogqirha botyando ukuba bakhethe isikrufu esilungileyo ngokukhawuleza ngaphandle kokuphazamisa ukuhamba komsebenzi. Ukongeza, uyilo lwe-screw kufuneka luqinisekise ukukwazi ukuzenzela ngokwakho, ukunciphisa imfuno yokugrumba kwangaphambili kwiimeko ezininzi, ezinokugcina ixesha elixabisekileyo kwigumbi lokusebenza.
3. Unyango loMphezulu – Ukuphucula ukuDityaniswa kweBone kunye nokuSebenza
Ukugqitywa komphezulu kwezikrufu zeCMF kudlala indima ebalulekileyo ekusebenzeni koomatshini kunye nempendulo yebhayoloji. Iipakethi zeCMF zodidi oluphezulu zokuzibhoboza zihlala zinendawo ene-anodized or polished.
I-Anodization yandisa ubukhulu be-oxide ye-surface, iphucula ukuxhathisa kwe-corrosion kunye nokuphucula i-osteointegration ngokudala i-bioactive surface ekhuthaza ukudibanisa kweeseli zethambo.
Ukucwenga kunciphisa izitenxo ze-microscopic, ukunciphisa ukunamathela kwebhaktheriya kunye nokunciphisa umngcipheko wokosuleleka emva kokuhlinzwa.
Ezinye iimveliso ezihambele phambili zinokudibanisa ukurhabaxa komhlaba ukuze uzinzo lokuqala kunye ne-anodization ye-biocompatibility yexesha elide. Xa uvavanya ipakethe yesikrufu, phinda ujonge iinkcukacha zonyango lomphezulu womenzi kunye nayo nayiphi na idatha ekhoyo yovavanyo lwezonyango.
4. Ukupakishwa okuNzala – Ukuthotyelwa kweMigangatho yeGumbi lokuSebenza
Nkqu nesikrufu somgangatho ophezulu sisengozini ukuba ukupakishwa kwaso kuyasilela ukuhlangabezana neemfuno ezinyumba. Ipakethi yeprimiyamu ye-CMF yokuzigoba izikrufu kufuneka ihanjiswe ngokutywinwa komntu ngamnye, ayinyumba, kwaye kulula ukuyivula kwipakethe ehambelana neeprothokholi zegumbi lokusebenza.
Jonga iipakethi ezineempawu:
Imiqobo ephindwe kabini yokhuseleko olongezelelweyo
Imihla yokuphelelwa ephawulwe ngokucacileyo kunye namanani eqashiso ukuze kulandelelwe
Uyilo olusebenziseka lula oluvumela ukufunyanwa ngokukhawuleza kwesikrufu ngaphandle kokwaphula ubuchule obunyumba
Abanye abavelisi banikezela ngeetreyi eziziintsholongwane ezilungele ukusetyenziswa eziququzelela izikrufu kunye nabaqhubi ngokulandelelana okunengqiqo, ukulungelelanisa inkqubo yotyando.
5. Ukuthotyelwa koMthetho - i-CE, i-FDA, kunye ne-ISO 13485 Certification
Kwishishini lezixhobo zonyango, iziqinisekiso zingaphezulu kwephepha - zibubungqina bomgangatho ongaguqukiyo kunye nokhuseleko. Ipakethe ye-CMF ethembekileyo yokuzigoba kufuneka ihlangabezane nemigangatho eyaziwayo kumazwe ngamazwe efana nale:
Ukumakishwa kwe-CE - Kufunwa ukuhanjiswa kwi-European Union, eqinisekisa ukuthotyelwa kwe-EU Medical Device Regulation (MDR).
Ukukhutshwa kwe-FDA-Iqinisekisa ukuba imveliso ihlangabezana neemfuno zokhuseleko kunye nokusebenza eUnited States.
Isiqinisekiso se-ISO 13485-Ibonisa ukuba inkqubo yolawulo lomgangatho womenzi ilungiselelwe ngokukodwa izixhobo zonyango.
Ukuthenga kubaboneleli abaqinisekisiweyo akuqinisekisi ukuthembeka kwemveliso kuphela kodwa kunciphisa imingcipheko esemthethweni kunye nokuthotyelwa kwezibhedlele kunye neekliniki.
Kwi-Shuangyang Medical, asikho kuphela umthengisi kodwa kunye nomenzi we-1.5 mm CMF self-drilling screw pack. Idizayinelwe kwaye iveliswe ngaphakathi, izikrufu zethu zenziwe nge-premium ye-Ti-6Al-4V ye-medical-grade titanium alloy kwaye zenziwe kusetyenziswa iteknoloji ye-Swiss TONRNOS CNC echanekileyo ngokuchanekileyo kunye nokuhambelana. Ngonyango lwe-anodized surface, ukhetho lobungakanani obuninzi, ukupakishwa okungenazintsholongwane, kunye nokuthotyelwa ngokupheleleyo kwe-CE, FDA, kunye nemigangatho ye-ISO 13485, iimveliso zethu zakhiwe ukuhlangabezana neemfuno eziphezulu zokusebenza zotyando.
Ukusebenzisana nathi kuthetha ukusebenza ngokuthe ngqo nomthombo-ukuqinisekisa amaxabiso akhuphisanayo, ukubonelela okuzinzile, kunye nomgangatho ongaguqukiyo kwiimfuno zakho zotyando ze-CMF.
Ixesha lokuposa: Aug-11-2025