Imarike yehlabathi yeiindawo zeplastiki zonyango zesiko ifikelele kwi-8.5 yeebhiliyoni zeedola ngo-2024, ikhuthazwa ziindlela zokunyanga amayeza omntu kunye notyando olungephi. Nangona oku kukhula, kwendabukoimveliso ukulwa nobunzima boyilo kunye nokuthotyelwa kolawulo (FDA 2024). Eli phepha livavanya ukuba iindlela zokwenziwa kwe-hybridi zidibanisa njani isantya, ukuchaneka, kunye nokuqina ukuhlangabezana neemfuno ezintsha zokhathalelo lwempilo ngelixa ubambelela ISO 13485 imigangatho.
Indlela yokusebenza
1.Uyilo loPhando
Kusetyenziswe iindlela ezixubeneyo:
● Uhlalutyo lobungakanani bedatha yemveliso evela kubenzi bezixhobo zonyango abangama-42
● Izifundo ezisuka kwii-OEM ezi-6 eziphumeza iiplatifti zoyilo ezincediswa yi-AI
2.Isikhokelo sobuGcisa
●Isoftware:Materialize Mimics® ukwenzela imodeli ye-anatomical
●Iinkqubo:Ukubumba i-Micro-injection (Arburg Allrounder 570A) kunye ne-SLS 3D yokushicilela (EOS P396)
● Izixhobo:I-PEEK yodidi lwezonyango, i-PE-UHMW, kunye ne-silicone composites (i-ISO 10993-1 eqinisekisiweyo)
3.IiMetrikhi zokuSebenza
● Ukuchaneka komgangatho (ngokweASTM D638)
● Ixesha lokukhokela imveliso
● Iziphumo zokuqinisekiswa kwe-Biocompatibility
Iziphumo kunye noHlahlelo
1.Efficiency iinzuzo
Ukuveliswa kwenxalenye yesiko kusetyenziswa ukuhamba komsebenzi wedijithali kuncitshisiwe:
● Ixesha lokuyila ukuya kwiprototype ukusuka kwiintsuku ezingama-21 ukuya kwezi-6
● Inkunkuma yezinto eziphathekayo ngama-44% xa kuthelekiswa noomatshini beCNC
2.Iziphumo zoNyango
● Izikhokelo zotyando ezijoliswe kwisigulana ziphucule ukuchaneka komsebenzi ngama-32%.
● I-3D-printed implants ye-orthopedic ibonise i-98% ye-osseointegration phakathi kweenyanga ze-6
Ingxoxo
1.Abaqhubi bezobuGcisa
● Izixhobo zokuyila ezivelisayo zenze ukuba iijiyometri ezintsonkothileyo zingakwazi ukuphunyezwa ngeendlela zokuthabatha
● Ulawulo lomgangatho we-inline (umz., iinkqubo zokuhlola umbono) zehlise izinga lokulahlwa ukuya ku-<0.5%
2.Izithintelo Zokunikwa Kwabanye
● I-CAPEX ephezulu yokuqala koomatshini abachanekileyo
●Iimfuno ezingqongqo zokuqinisekisa i-FDA/EU MDR zokwandisa ixesha lokuya kwintengiso
3.Iimpembelelo zoShishino
● Izibhedlele eziseka amaziko okuvelisa angaphakathi (umzekelo, iMayo Clinic's 3D Printing Lab)
● Shift ukusuka kwimveliso eninzi ukuya kwimveliso esasazwayo efunekayo
Ukuqukumbela
Itekhnoloji yokwenziwa kweDijithali yenza ukuba kukhawuleziswe, kungabizi kakhulu ukuveliswa kwezixhobo zeplastiki zonyango ngelixa kugcinwe ukusebenza kweklinikhi. Ukuthathwa komntwana kwixesha elizayo kuxhomekeke koku:
● Ukulinganisa iiprothokholi zokuqinisekisa zofakelo olwenziweyo olongezelelweyo
● Ukuphuhlisa ikhonkco lokubonelela nge-agile kwimveliso yeebhetshi ezincinci
Ixesha lokuposa: Sep-04-2025
