Isembozo sokuvikela se-silicone esiwuketshezi sokusikwa kwe-laparoscopic trocar

Isembozo sokuvikela se-silicone esiwuketshezi sokusikwa kwe-laparoscopic trocar

 

Kusukela Ekuklanyweni Kuya Ekulethweni: Kanjani I-Ansix Ubuchwepheshe Bungochwepheshe Bokubumba Umjovo We-Silicone Oketshezi Kwamadivayisi Okuhlinzwa Abalulekile

Isingeniso

Ezweni elibaluleke kakhulu lokukhiqizwa kwamadivayisi ezokwelapha, ukunemba, ukuthembeka, kanye nesivinini akunakuxoxiswana ngakho. Akukho ndawo lapho lokhu kusobala khona ngaphezu kokukhiqizwa kwezingxenye ezilahlwayo zokuhlinzwa okungangenisi kakhulu, lapho ingxenye eyodwa ingathinta ukuphepha kwesiguli kanye nempumelelo yenqubo. Ohamba phambili kule ndawo yi-Ansix Tech, uchwepheshe ekubumbeni okuthuthukisiwe komjovo, oye waphelelisa ukukhiqizwa kwezimbozo zokuvikela ze-liquid silicone rubber (LSR) zokusika kwe-laparoscopic trocar. Lesi sihloko sigxila ohambweni oluyinkimbinkimbi lokuletha le ngxenye ebalulekile emakethe—kusukela ekwakhiweni kokuqala kanye nesitifiketi esiqinile kuya ekukhiqizweni okukhulu okwenziwe kahle—kubonisa indlela ubuchwepheshe be-Ansix Tech obuletha ngayo inani elingenakuqhathaniswa kanye nokuthembeka embonini yezokwelapha.

 

1. Umkhiqizo: Ukuhlangabezana Nesidingo Esibalulekile Sokuhlinzwa

Ukuhlinzwa kwe-laparoscopic kuncike kuma-trocar ukudala ama-port avaliwe odongeni lwesisu. Isembozo esivikelayo, esiyingxenye encane kodwa ebalulekile, senza imisebenzi eminingi: sigcina i-pneumoperitoneum, sivimbela ukulimala kwezicubu ngesikhathi sokushintshana kwezinsimbi, futhi sinciphisa ingozi yokutheleleka kwendawo yokuhlinzwa. Isidingo semakethe siqhutshwa ukushintshela emhlabeni wonke ezinqubweni ezingangenisi kakhulu, inhlanzeko eqinile amazinga, kanye nesidingo esingaguquki samadivayisi asetshenziswa kanye kuphela, ahlanzekile.

 

Isembozo esivikelayo se-Ansix Tech sakhiwe njengesigqoko esinodonga oluncane, esiguquguqukayo esinokuvala izindebe okunembile kanye nezici zokunamathela. Umklamo kumele ulinganisele ubumnene bokuphepha kwesiguli nokuqina ukuze kumelwane nezindlela zokusebenzisa eziphindaphindwayo, konke lokhu kungenziwa ngezinga elifanele ngaphandle kokuphazamiseka.

 

2. Ukuzulazula Ezweni Elilawulayo: Izindinganiso Zomkhiqizo

Njengedivayisi yezokwelapha yeSigaba II, isembozo sokuvikela kumele sihambisane nezindinganiso zomhlaba wonke. Ukuhambisana kwezinto eziphilayo kuqinisekiswa ngokwe-ISO 10993-1, okuqinisekisa ukuthi akukho miphumela eyingozi, ebangela ukuzwela, noma ecasulayo. Ukukhiqizwa kwenzeka ngaphansi koHlelo Lokuphatha Ikhwalithi oluqinisekiswe yi-ISO 13485:2016, olugunyaza ukulawulwa kwenqubo okuqinile, ukulandeleka, kanye nokuphathwa kwengozi. Ngaphezu kwalokho, umkhiqizo nezinto zawo zivame ukudinga ukuhambisana ne-FDA 21 CFR Part 820 kanye nokumakwa kwe-CE ngaphansi koMthethonqubo Wedivayisi Yezokwelapha we-EU (MDR). Ukuzibophezela kwe-Ansix Tech kulezi zindinganiso kufakwe kuzo zonke izigaba zephrojekthi, kusukela ekukhetheni izinto kuya ekupakishweni kokugcina.

 

3. Umklamo Wesibonelo: Ukuthuthukiswa Okuqhutshwa Yisilingiso

Ngaphambi kokuba kunqunywe noma iyiphi insimbi, i-Ansix Tech isebenzisa indlela ye-Design for Manufacturing (DFM) eqhutshwa ukulingisa. Besebenzisa amathuluzi athuthukile e-CAE njenge-Moldex3D kanye ne-SIGMASOFT®, onjiniyela benza ukuhlaziya kokugeleza kwesikhunta ukuze babikezele amaphethini okugcwalisa, bathole izithiyo zomoya ezingaba khona, balungise izindawo zamasango, futhi balingise ukuziphatha kokupholisa. Lokhu kucubungula okubonakalayo kubalulekile kwi-LSR, enefasitela elincane lokucubungula futhi ezwela amazinga okushisa. Ngokusebenzisa inqwaba yezinguquko ezingokoqobo, ithimba lingalinganisa ukwakheka kwemigodi eminingi, libuyisele imiphumela yamandla adonsela phansi ekugelezeni, futhi livimbele amaphutha njengezithombe ezimfushane noma ukwelashwa okungaphelele—konke ngaphambi kokuba kuqale ukusetshenziswa kwamathuluzi.

 

4. Ukuqinisekiswa Kokukhiqiza kanye Nesitifiketi Sokukhiqiza Ngokuningi

Uma isikhunta se-prototype sesilungile, kwenziwa inqubo yokuqinisekisa ephelele. Lokhu kufaka phakathi Ukuhlolwa Kwesihloko Sokuqala (i-FAI), ukuqinisekiswa kobukhulu kusetshenziswa imishini yokulinganisa ehlanganisiwe (i-CMM), kanye nokuhlolwa kokusebenza ngaphansi kwezimo zokuhlinzwa ezilingisiwe. Amapharamitha enqubo avaliwe nge-Design of Experiments (DOE) ukuqinisekisa ukuphindeka. Kuphela ngemva kokudlula lokhu kuhlolwa lapho iphrojekthi iqhubekela esigabeni sokufaneleka kokukhiqiza, lapho amaqoqo alandelanayo ekhiqizwa ngaphansi kokubhekwa kwesistimu ephelele yekhwalithi. Isinyathelo sokugcina ukuthola imvume yamakhasimende, kanye, lapho kudingeka khona, isitifiketi sokulawula sokukhiqiza ngobuningi—ubufakazi bokuqina kwentuthuko ye-Ansix Tech. Umzila wepayipi.

 

5. Ukukhethwa Kwezinto Ezibalulekile: Isisekelo Sokusebenza Nokuphepha

Ukukhetha izinto zokwakha kubaluleke kakhulu. I-Ansix Tech icacisa ama-LSR ebanga lezokwelapha, aqanjwe ngeplatinum anikeza ukuhambisana okuhle kakhulu kwezinto eziphilayo, ukucaca, kanye nokuziphatha kokwelapha okuqhubekayo. Ukukhetha okuvamile kufaka phakathi:

 

Uchungechunge lwe-DuPont™ Liveo™ C6 (isb., C6‑530, C6‑540): Lawa ma-elastomer amabili, akhiwe ngeplatinum, aklanyelwe ukubumba amadivayisi ezokwelapha ngemijovo, okuhlanganisa nezinhlelo zokusebenza zesikhashana ezingafakwa. Anikeza ubulukhuni be-Shore A kusukela ku-20 kuya ku-70, ahlangabezana nezidingo ze-USP Class VI, futhi abonisa ukungcoliswa kwesikhunta okuphansi.

 

Uchungechunge lwe-Wacker SILPURAN® noma i-ELASTOSIL® LR 3000: Lezi zinto zisetshenziswa kabanzi ekubumbeni kwe-LSR yezokwelapha, zinikeza ubumsulwa obuphezulu, amandla amahle okudabuka, kanye nokuqina ebangeni elibanzi lokushisa.

 

I-Momentive Silopren LSR 2740: Ibanga elizinamathelayo elinganamathela ezisekelweni ezahlukene ngaphandle kwe-primer, liwusizo uma umklamo uhlanganisa izinto zokufakelwa zepulasitiki noma zensimbi.

 

I-LSR ekhethiwe kumele ihlangabezane nezidingo zemishini nezokusebenza kuphela kodwa futhi nokuhambisana kokubulala amagciwane (isb., i-ethylene oxide, i-steam autoclave) kanye nezidingo zemibhalo yokulawula.

 

6. Ukuhlaziywa Kokugeleza Kwesikhunta (i-DFM) Ngokuningiliziwe

I-viscosity ephansi ye-LSR kanye ne-kinetics yokwelapha okusheshayo kudinga ibhalansi yokugeleza kwesikhunta evelele. Ithimba lokulingisa le-Ansix Tech lisebenzisa ukuhlaziywa kwezinto ezilinganiselwe ze-3D ukuze libonise inqubo ephelele yokujova. Imiphumela eyinhloko ifaka:

 

Ukulungiswa kwesango: Ukunquma inani, usayizi, kanye nendawo yamasango ukuqinisekisa ukugcwaliswa okufanayo nokugwema ukugeleza.

 

Ukuhlaziywa kokushisa: Ukudweba imephu yokusatshalaliswa kwezinga lokushisa kulo lonke isikhunta ukuze kufezwe ukwelashwa okufanayo; amazinga okushisa angalingani angaholela ezindaweni ezingapholi kahle noma ekuvuvukeni kwangaphambi kwesikhathi.

 

Umklamo wokungenisa umoya: Ukuthola izindawo ezifanele zokungenisa umoya ukuze kukhishwe umoya futhi kuvinjelwe izimpawu zokusha noma izikhala.

 

Ukuhlelwa kwesiteshi sokupholisa: Ukuqinisekisa ukususwa kokushisa okuphumelelayo ukuze kuncishiswe isikhathi sokujikeleza ngaphandle kokubeka engcupheni ikhwalithi yengxenye.

 

Lokhu kulingisa kusengaphambili kunciphisa ukuzama kanye namaphutha, kunciphisa izikhathi zokuhola, futhi kunciphisa kakhulu izindleko zokuthuthukisa.

 

7. Izici Eziyinhloko Zomklamo Wesikhunta se-LSR

Izikhunta ze-LSR zihluke kakhulu ezikhunta ze-thermoplastic zendabuko. Idizayini ye-Ansix Tech inezici eziningana ezibalulekile:

 

Uhlelo Lokushisa: I-LSR iyaphola ku-180–220 °C, ngakho-ke izikhunta zifakwe ama-heater e-cartridge noma iziteshi zokushisa uwoyela ukuze kugcinwe izinga lokushisa elifanayo nelihlala njalo.

 

Uhlelo lwe-Cold runner: I-manifold epholile isabalalisa i-LSR engakapheki kuyo yonke indawo, ivimbele ukuphola kusenesikhathi kuma-runner. Ama-valve okuvala inaliti aqinisekisa ukuhlukaniswa kwesango okuhlanzekile.

 

Uhlelo lwe-vacuum: Ukuze kuqedwe ukubanjwa komoya ezindaweni ezincane zodonga, isikhunta sivame ukufakwa amaphampu e-vacuum akhipha umgodi ngaphambi kokujova.

 

Uhlelo lokukhipha umoya: Njengoba i-LSR inwebeka, ukukhipha umoya kumele kube mnene kodwa kube kuhle. Izinketho zifaka phakathi amaphini e-ejector, i-air blast, noma ama-ejectors ohlobo lwebhulashi.

 

Ukuqondisa okunembe kakhulu: Ukuze kumelwane nokukhula kokushisa nokugcina ukuhambisana, izikhunta zisebenzisa izinsika zokuqondisa eziqinile kanye nezihlahla.

 

8. Izinselele Ekukhiqizeni Nokucubungula Isikhunta

Ukwakha isikhunta esinjalo kudinga ukunemba okukhulu. Ingaphakathi kanye nomgodi kumele kupholishwe kuze kube sekupheleni kwesibuko (ngokuvamile kungcono kune-Ra 0.025 µm) ukuze kube lula ukukhululwa kwengxenye futhi kugweme ukunamathela. Ukugcina ukubekezelelana okuqinile (± 0.01 mm) kuzo zonke izimbobo eziningi kubalulekile ukuze izingxenye zihambisane kahle. Ukuhlanganiswa kwemigqa yokushisa, ukupholisa, kanye ne-vacuum ngaphakathi kwesikhala esilinganiselwe kunezela ubunzima. Ngesikhathi sokucubungula, izinselele zifaka phakathi ukuphatha i-viscosity ephansi ye-LSR (engaholela ekukhanyeni), ukuqinisekisa ukuphuma okuphelele komgodi, kanye nokulawula isilinganiso esinembile kanye nokuhlanganiswa kwezinto ezimbili.

 

9. Ukuhamba Komsebenzi Wokucubungula Isikhunta

I-Ansix Tech ilandela umsebenzi ohlelekile:

 

Ukubuyekezwa komklamo - Ukuqedela amamodeli nemidwebo ye-3D.

 

Ukuthengwa kwezinto – Insimbi yokubumba eqinisekisiwe yokutholakala (isb., S136, H13).

 

Umshini wokugaya onzima – Ukugaya, ukubhoboza, kanye nokujika amapuleti esikhunta.

 

Ukwelashwa ngokushisa – Ukuqinisa kube yi-48–52 HRC ukuze kuvinjwe ukuguguleka.

 

Umshini wokugaya ngokunemba – i-CNC milling, i-EDM (umshini wokugaya ngogesi) ukuze uthole imininingwane emincane.

 

Ukupholisha kanye nokulungisa - Ukufinyelela ukuqeda okufunekayo kobuso.

 

Ukuhlanganiswa - Izinto zokufaka, iziqondiso, izinhlelo zokukhipha, kanye nezingxenye ezisizayo.

 

Ukuhlola nokulungisa - Isivivinyo sisebenza emshinini wokujova we-LSR ukuqinisekisa ukusebenza.

 

10. Ukukhethwa Kwensimbi Yesikhunta

Isikhunta kumele simelane nokushisa okuphezulu isikhathi eside kanye nama-LSR compounds arhabaxa. I-Ansix Tech ivame ukukhetha izinsimbi eziqinile nezimelana nokugqwala ezifana nalezi:

 

I-S136 (AISI 420) – Inikeza ukupholisha okuhle kakhulu kanye nokumelana nokugqwala, ilungele isikhunta se-LSR sezokwelapha.

 

I-H13 (AISI H13) – Insimbi esebenza ngokushisa ekwazi ukudlulisa ukushisa kahle kanye nokumelana nokukhathala, efanelekile ezikhumbeni ezishisayo.

 

2344 (AISI P20+Ni) – Insimbi eqiniswe ngaphambilini evame ukusetshenziselwa izisekelo zesikhunta.

 

Lezi zinto ziqinisekisa ukuthi isikhunta siphila isikhathi esingaphezu kwemijikelezo engu-500,000, okunciphisa izindleko zamathuluzi ngengxenye ngayinye.

 

11. Ubunzima Ekubunjweni Komjovo we-LSR

Ngaphandle kokuklama isikhunta, izinselele zenqubo zifaka:

 

Ukuvaleka komoya: Izingxenye zodonga oluncane zingabamba umoya, okuholela emigodini engenalutho. Usizo lwe-vacuum luvame ukudingeka.

 

Ukwakheka kwe-flash: Ukuchachamba okuphansi kwe-LSR kudinga ukulingana okuqinile kwesikhunta kanye namandla aqondile okubopha.

 

Ukulawula ukuphulukiswa: Ukungaphulukiswa kahle kwezingxenye kuholela ezingxenyeni ezinamathelayo; ukuphulukiswa ngokweqile kungabangela ukuphuka. Ukulawula izinga lokushisa nesikhathi okunembile kubalulekile.

 

Ukuphathwa kwezinto: Izingxenye ze-LSR (A no-B) kumele zigcinwe zihlukene ngokuphelele kuze kube yilapho kujovwa; amamitha kanye nabaxubi kumele balinganiswe kahle.

 

12. Ukuthuthukisa Inqubo Yokubumba Umjovo

I-Ansix Tech igxile ekuthuthukiseni inqubo eqhubekayo ukuze kuthuthukiswe ukusebenza kahle kanye nezindleko zokulawula:

 

Ukulungiswa kwepharamitha: Ukusebenzisa i-DOE ukuthola isivinini somjovo esifanele, ingcindezi, izinga lokushisa, kanye nesikhathi sokwelapha.

 

Ukuzenzakalela: Ukusebenzisa ukususwa kwezingxenye zerobhothi, ukuhlolwa kombono, kanye nokupakishwa okuzenzakalelayo ukuze kuncishiswe umsebenzi futhi kwandiswe ukuhambisana.

 

Ukunciphisa isikhathi somjikelezo: Ukwenza ngcono imijikelezo yokupholisa/yokushisa ngokulawula izinga lokushisa kwesikhunta okuthuthukisiwe.

 

Ukonga izinto zokwakha: Ngokulungisa kahle osayizi bomgijimi nokusebenzisa ubuchwepheshe bomgijimi obandayo, imfucuza yezinto zokwakha iyancishiswa.

 

Ukusebenza kahle kwamandla: Ukusebenzisa imishini yokujova eqhutshwa yi-servo kanye nezinhlelo zokushisa ezisebenza kahle ukuze kuncishiswe ukusetshenziswa kwamandla.

 

Lezi zinyathelo zihlangene zehlisa izindleko zeyunithi ngayinye yesembozo sokuvikela, zilethe ukonga okuqondile kumakhasimende.

 

13. Ukulawulwa Kwekhwalithi Nokuqinisekiswa

Iqoqo ngalinye lokukhiqiza lingaphansi kohlelo lwekhwalithi olunezingqimba eziningi:

 

Ukuhlolwa kwezinto ezingenayo: Izitifiketi zokuhlaziywa ziyaqinisekiswa kuzo zonke izingxenye ze-LSR.

 

Ukuhlolwa kwangaphakathi kwenqubo: Amapharamitha ayisihluthulelo (izinga lokushisa, ingcindezi, isikhathi somjikelezo) aqashwa ngesikhathi sangempela. Amasampula alinganiswa ngezikhathi ezithile ngobukhulu nesisindo.

 

Ukulawulwa Kwenqubo Yezibalo (i-SPC): Amashadi okulawula alandelela ubukhulu obubalulekile ukuze abone noma yikuphi ukuzulazula kwenqubo.

 

Ukuhlolwa kokugcina: Ukuhlolwa okubonakalayo okungu-100% ngaphansi kokukhulisa; ukuhlolwa kokusebenza (ukusebenza kokuvala) ngokusekelwe ekuthathweni kwesampula.

 

Ukulandelelwa: Iqoqo ngalinye lixhunywe ezindaweni zokusetshenziswa, izilungiselelo zomshini, kanye namarekhodi omqhubi, okugcwalisa izidingo ze-ISO 13485 zokulandelelwa okugcwele.

 

14. Ukupakishwa Nokuhlanza

Izingxenye eziqediwe ziyahlanzwa futhi zipakishwe egumbini lokuhlanza le-ISO Class 7 (Class 10,000). Izinto zokupakisha ziqinisekiswa ukuze kugcinwe ukungabi namagciwane. Umkhiqizo uvame ukuhlanzwa nge-ethylene oxide (EtO) noma i-gamma irradiation, ngemijikelezo yokuhlanza eqinisekisiwe ukuqinisekisa ukusebenza kahle ngaphandle kokulimaza i-silicone.

 

15. Inqubo Yokulethwa Okusheshayo

I-Ansix Tech ithuthukise indlela kusukela ekukhiqizweni komqondo kuya komthamo ukuze ihlangabezane nezikhathi zemakethe eziphuthumayo. Le nqubo "yokulethwa okusheshayo" incike ku:

 

Ubunjiniyela obuhambisanayo: Ukuklama, ukulingisa, kanye nokulungiselela amathuluzi kwenzeka ngesikhathi esisodwa.

 

Amasu okusebenzisa amathuluzi ngokushesha: Kuma-prototypes, ama-insert esikhunta aphrintiwe yi-SLA angakhiqiza izingxenye ezisebenzayo ngezinsuku.

 

Ukuhlanganiswa kwabahlinzeki: Ukubambisana okuqinile nabahlinzeki bensimbi, abathengisi bezingxenye, kanye nezinhlangano zezitifiketi ukuze kugwenywe ukubambezeleka.

 

Ukuqaliswa kokukhiqiza okuhlosiwe: Ukuqaliswa komthamo ophansi kusenesikhathi kunciphisa ingozi yenqubo ngaphambi kokukhiqiza okugcwele.

 

Le ndlela esheshayo ivumela i-Ansix Tech ukuthi ilethe izingxenye eziqinisekisiwe emavikini angu-8-10 kusukela ekuqandeni komklamo.

 

16. Ulwazi Lwemboni lwe-Ansix Tech kanye Nokuzibophezela Kwamakhasimende

Njengoba ineminyaka engaphezu kweshumi yobuchwepheshe ekubunjweni kwe-LSR yezokwelapha, i-Ansix Tech yakhe iphothifoliyo yamaphrojekthi aphumelelayo kuzo zonke izivalo zokuhlinzwa, izingxenye ze-catheter, kanye namadivayisi ezokwelapha agqokwayo. Onjiniyela benkampani banolwazi oluhle ngezimpawu zokuziphatha kwe-LSR, ukwakheka kwesikhunta, kanye nokuhambisana nemithetho. Lokhu okuhlangenwe nakho okujulile kuhumusha ekuphindaphindweni okuncane kokuklama, ingozi ephansi yokubambezeleka kwephrojekthi, futhi ekugcineni, uchungechunge lokunikezela oluthembeke kakhulu kumakhasimende.

 

Okubaluleke kakhulu, i-Ansix Tech izinikele ekunciphiseni izindleko eziphelele zobunikazi kumakhasimende. Lokhu akufezwa ngokusika amakhona, kodwa ngobunjiniyela obuhlakaniphile:

 

Ukukhetha izinto: Kunconywa izinga le-LSR elingabizi kakhulu elihlangabezana nazo zonke izindinganiso zokusebenza.

 

Ukuthuthukiswa kwenqubo: Ukwandisa isivuno nokunciphisa isikhathi somjikelezo ukuze kwehliswe izindleko ngengxenye ngayinye.

 

Ukuthuthukiswa kokusebenza kahle: Ukuzenzakalelayo kwemisebenzi yangemva kokubumba nokusebenzisa izimiso zokukhiqiza ezingenamsoco.

 

Ngokugxila kulezi zindlela, i-Ansix Tech yehlisa kakhulu izindleko zezingxenye eziningi ngaphandle kokubeka engcupheni ikhwalithi—isiphakamiso senani esizwakala kakhulu ezimakethe zezempilo eziqaphela izindleko.

 

Isiphetho

Uhambo lwesembozo sokuvikela se-silicone esiwuketshezi kusukela esidingweni sokuhlinzwa kuya kudivayisi yezokwelapha ekhiqizwe ngobuningi, eqinisekisiwe luwubufakazi bokubambisana kobunjiniyela obuthuthukisiwe, izinhlelo zekhwalithi eqinile, kanye nobuchwepheshe obujulile bezinto ezibonakalayo. I-Ansix Tech iyisibonelo sendlela umlingani ogxile ekubumbeni umjovo angahamba ngayo kule ndawo eyinkimbinkimbi, eletha ingxenye ehlangabezana nezindinganiso eziphakeme zokusebenza, ukuphepha, kanye nokungabizi. Njengoba ukuhlinzwa okungangenisi kakhulu kuqhubeka nokukhula, indima yokubumba ngokunemba kwe-LSR izokhula kuphela—futhi ngomlando wayo oqinisekisiwe, i-Ansix Tech ikulungele ukuhlala ingumngane othembekile kubasunguli bemishini yezokwelapha emhlabeni jikelele.

 

I-Ansix Tech Co Ltd

Uma unezinhlelo ezihlobene nesembozo sokuvikela se-silicone se-Liquid sokusika i-trocar nge-laparoscopic, ungasithinta noma nini. Sizoguqula imibono yakho ibe ngokoqobo, sikuvumele ufeze amaphupho akho, futhi sithole ama-oda amakhulu emakethe. Ulwazi lwethu lokuxhumana luthi info@ansixtech.com. Noma xhumana ne-CTO yethu, nge-imeyili: stephen@ansixtech.com

 

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