Murfin kariya na silicone mai ruwa don yanke trocar na laparoscopic
Murfin kariya na silicone mai ruwa don yanke trocar na laparoscopic
Daga Zane zuwa Isarwa: Yadda Ansix Fasaha ta ƙware a fannin gyaran allurar silicone ta ruwa don na'urorin tiyata masu mahimmanci
Gabatarwa
A cikin duniyar kera na'urorin likitanci mai cike da matsaloli, daidaito, aminci, da sauri ba za a iya yin sulhu ba. Babu inda wannan ya fi bayyana fiye da samar da kayan da za a iya zubar da su don tiyata mai ƙarancin shiga jiki, inda sashi ɗaya zai iya shafar lafiyar majiyyaci da nasarar tsarin aiki. A sahun gaba a wannan fanni akwai Ansix Tech, ƙwararre a fannin gyaran allurar rigakafi, wanda ya inganta kera murfin kariya na robar silicone (LSR) don yankewar trocar ta laparoscopic. Wannan labarin ya yi nazari kan tafiya mai sarkakiya ta kawo wannan muhimmin sashi zuwa kasuwa - daga ƙira ta farko da takaddun shaida mai tsauri zuwa ingantaccen samar da kayayyaki - yana nuna yadda ƙwarewar Ansix Tech ke ba da ƙima da aminci mara misaltuwa ga masana'antar likitanci.
- Samfurin: Biyan Bukatar Tiyata Mai Muhimmanci
Tiyatar laparoscopic ta dogara ne akan trocars don ƙirƙirar mashigai a bangon ciki. Murfin kariya, ƙaramin abu amma mai mahimmanci, yana aiki da ayyuka da yawa: yana kula da pneumoperitoneum, yana hana rauni a cikin kyallen jiki yayin musayar kayan aiki, kuma yana rage haɗarin kamuwa da cutar wurin tiyata. Bukatar kasuwa tana faruwa ne sakamakon sauyawar duniya zuwa hanyoyin da ba su da tasiri sosai, da tsauraran tsafta. ƙa'idodi, da kuma buƙatar na'urori masu amfani da su sau ɗaya, waɗanda ba a tsaftace su ba.
An tsara murfin kariya na Ansix Tech a matsayin siririn bango mai sassauƙa tare da leɓunan rufewa daidai da fasalulluka na haɗe-haɗe. Tsarin dole ne ya daidaita laushi don amincin majiyyaci da juriya don jure wa maimaita hanyoyin kayan aiki, duk yayin da ake iya ƙera su ba tare da lahani ba.
- Kewaya Tsarin Mulki: Ka'idojin Samfura
A matsayin na'urar likita ta Aji II, murfin kariya dole ne ya bi ƙa'idodi na duniya. Ana tabbatar da daidaiton halittu bisa ga ISO 10993-1, yana tabbatar da cewa babu wani abu mai guba ga ƙwayoyin halitta, mai tayar da hankali, ko kuma mai tayar da hankali. Samarwa yana faruwa ne a ƙarƙashin Tsarin Gudanar da Inganci wanda aka ba da takardar shaida ga ISO 13485:2016, wanda ke ba da umarnin sarrafa tsari mai tsauri, bin diddigin abubuwa, da kuma kula da haɗari. Bugu da ƙari, samfurin da kayansa galibi suna buƙatar bin ka'idodin FDA 21 CFR Sashe na 820 da kuma alamar CE a ƙarƙashin Dokar Na'urar Lafiya ta EU (MDR). Jajircewar Ansix Tech ga waɗannan ƙa'idodi yana cikin kowane matakin aiki, daga zaɓin kayan zuwa marufi na ƙarshe.
- Tsarin Samfura: Ci gaba Mai Sauƙi
Kafin a yanke wani ƙarfe, Ansix Tech tana amfani da tsarin ƙira don kera ƙarfe (DFM) wanda ke jagorantar kwaikwayo. Ta amfani da kayan aikin CAE na zamani kamar Moldex3D da SIGMASOFT®, injiniyoyi suna yin nazarin kwararar mold don hango yanayin cikawa, gano tarkon iska mai yuwuwa, inganta wuraren ƙofa, da kuma kwaikwayon halayen warkarwa. Wannan samfurin kama-da-wane yana da mahimmanci ga LSR, wanda ke da taga mai kunkuntar sarrafawa kuma yana da saurin yanayin zafi. Ta hanyar gudanar da gwaje-gwaje da yawa na kama-da-wane, ƙungiyar za ta iya daidaita shimfidu da yawa na rami, rama tasirin nauyi akan kwarara, da hana lahani kamar gajerun hotuna ko maganin da bai cika ba - duk kafin fara aikin.
- Takaddun Tabbatar da Masana'antu da Takaddun Shaida na Samar da Yawan Jama'a
Da zarar an shirya samfurin samfurin, ana aiwatar da cikakken tsarin tabbatarwa. Wannan ya haɗa da Binciken Mataki na Farko (FAI), tantance girma ta amfani da injunan aunawa masu daidaitawa (CMM), da gwajin aiki a ƙarƙashin yanayin tiyata da aka kwaikwayi. Ana kulle sigogin tsari ta hanyar Tsarin Gwaje-gwaje (DOE) don tabbatar da maimaitawa. Sai bayan an wuce waɗannan gwaje-gwajen ne aikin zai ci gaba zuwa matakin cancantar samarwa, inda ake samar da rukuni-rukuni a jere ƙarƙashin cikakken kulawar tsarin inganci. Mataki na ƙarshe shine samun amincewar abokin ciniki da kuma, inda ake buƙata, takardar shaidar ƙa'ida don samar da taro - shaida ce ga ƙarfin ci gaban Ansix Tech. Bututun.
- Zaɓin Kayan Aiki: Tushen Aiki da Tsaro
Zaɓin kayan aiki shine mafi mahimmanci. Ansix Tech ta ƙayyade LSRs masu ƙarfin platinum waɗanda aka yi wa ado da su a fannin likitanci waɗanda ke ba da kyakkyawan jituwa da halittu, haske, da kuma ɗabi'ar warkarwa mai kyau. Zaɓin da aka saba yi ya haɗa da:
Jerin DuPont™ Liveo™ C6 (misali, C6‑530, C6‑540): Waɗannan elastomers masu sinadaran guda biyu, waɗanda aka warkar da su da platinum an ƙera su ne don yin allurar na'urorin likitanci, gami da aikace-aikacen da za a iya dasawa na ɗan gajeren lokaci. Suna ba da tauri na Shore A daga 20 zuwa 70, suna cika buƙatun USP Class VI, kuma suna nuna ƙarancin gurɓataccen mold.
Wacker SILPURAN® ko jerin ELASTOSIL® LR 3000: Ana amfani da waɗannan kayan sosai don ƙera LSR na likitanci, suna ba da tsarki mai yawa, ƙarfin tsagewa mai kyau, da kwanciyar hankali a cikin kewayon zafin jiki mai faɗi.
Momentive Silopren LSR 2740: Ma'aunin mannewa wanda zai iya haɗawa da abubuwa daban-daban ba tare da faranti ba, yana da amfani idan ƙirar ta haɗa da abubuwan da aka saka a filastik ko ƙarfe.
Dole ne LSR ɗin da aka zaɓa ya biya ba kawai buƙatun injina da aiki ba, har ma da dacewa da tsaftacewa (misali, ethylene oxide, tururi autoclave) da buƙatun takaddun tsari.
- Binciken Gudun Mold (DFM) dalla-dalla
Ƙananan danko na LSR da kuma saurin warkar da ƙwayoyin cuta suna buƙatar daidaiton kwararar mold. Ƙungiyar kwaikwayo ta Ansix Tech tana amfani da nazarin abubuwan da suka shafi 3D don yin kwaikwayon cikakken tsarin allura. Babban sakamakon ya haɗa da:
Inganta ƙofa: Tantance lamba, girma, da wurin ƙofofin domin tabbatar da cikawa iri ɗaya da kuma guje wa yin jifa.
Binciken Zafi: Taswirar yadda zafin jiki ke yaɗuwa a kan mold ɗin don cimma daidaiton waraka; yanayin zafi mara daidaito na iya haifar da rashin warkewa ko kuma ƙonewar da ba ta yi ba da wuri.
Tsarin iska: Gano wuraren da iskar za ta iya shiga da kuma hana konewa ko kuma gurɓatattun abubuwa.
Tsarin tashar sanyaya: Tabbatar da ingantaccen cire zafi don rage lokacin zagayowar ba tare da lalata ingancin sashi ba.
Wannan kwaikwayon na gaba yana rage gwaji da kuskure, yana rage lokacin jagora, kuma yana rage farashin haɓakawa sosai.
- Muhimman Abubuwan Tsarin LSR Mold
Molds na LSR sun bambanta sosai da molds na gargajiya na thermoplastic. Tsarin Ansix Tech ya ƙunshi wasu muhimman abubuwa:
Tsarin Dumamawa: LSR yana warkewa a zafin 180–220 °C, don haka ana sanya masaku da na'urorin dumama harsashi ko hanyoyin dumama mai don kiyaye yanayin zafi iri ɗaya.
Tsarin mai gudu da sanyi: Manifol mai sanyaya yana rarraba LSR ɗin da ba a warke ba zuwa kowane rami, yana hana bushewa da wuri a cikin masu gudu. Bawuloli na rufe allura suna tabbatar da rabuwar ƙofa mai tsabta.
Tsarin injin tsotsar iska: Domin kawar da toshewar iska a sassan bango masu siriri, galibi ana sanya famfunan tsotsar iska waɗanda ke fitar da iska daga cikin ramin kafin a yi allura.
Tsarin fitar da iska: Ganin yadda LSR ke da sassauci, fitar da iska dole ne ya zama mai laushi amma mai kyau. Zaɓuɓɓuka sun haɗa da fil ɗin fitar da iska, fashewar iska, ko kuma fitar da iska irin ta goga.
Jagorar daidaito mai kyau: Don jure faɗaɗa zafi da kuma kiyaye daidaito, molds suna amfani da ginshiƙan jagora masu tauri da bushings.
- Kalubale a Masana'antar Mold da Sarrafa Mold
Yin irin waɗannan ƙira yana buƙatar daidaito sosai. Dole ne a goge tsakiyar da ramin zuwa madubi (sau da yawa ya fi Ra 0.025 µm) don sauƙaƙe sakin ɓangare da kuma guje wa mannewa. Kula da juriya mai ƙarfi (±0.01 mm) a cikin ramuka da yawa yana da mahimmanci don daidaiton ɓangaren. Haɗa layukan dumama, sanyaya, da injin tsabtace iska a cikin sarari mai iyaka yana ƙara rikitarwa. A lokacin sarrafawa, ƙalubalen sun haɗa da sarrafa ƙarancin danko na LSR (wanda zai iya haifar da walƙiya), tabbatar da cikakken fitar da rami, da kuma sarrafa daidaitaccen rabo da haɗa kayan ɓangarorin biyu.
- Tsarin Aikin Sarrafa Mold
Ansix Tech tana bin tsarin aiki mai kyau:
Sharhin zane - Kammala samfuran 3D da zane-zane.
Sayen kayan aiki - Samun ƙarfe mai inganci (misali, S136, H13).
Injin da ba shi da ƙarfi - Niƙa, haƙa, da kuma juya faranti na mold.
Maganin zafi - Taurare zuwa 48-52 HRC don juriya ga lalacewa.
Injin gyara - Injin niƙa CNC, EDM (injin fitar da wutar lantarki) don cikakkun bayanai.
Gogewa da rubutu - Cimma nasarar da ake buƙata ta saman.
Haɗawa - Shigar da abubuwan sakawa, jagorori, tsarin fitarwa, da kayan taimako.
Gwaji & Daidaitawa - Gwaji yana gudana akan injin allurar LSR don tabbatar da aiki.
- Zaɓin Karfe na Mold
Dole ne mold ɗin ya jure wa yanayin zafi mai yawa da kuma mahaɗan LSR masu lalatawa na dogon lokaci. Ansix Tech yawanci yana zaɓar ƙarfe masu juriya ga tsatsa, masu ƙarfi kamar:
S136 (AISI 420) – Yana bayar da kyakkyawan juriya ga gyambo da kuma tsatsa, wanda ya dace da molds na LSR na likitanci.
H13 (AISI H13) – Karfe mai aiki da zafi wanda ke da kyakkyawan juriya ga zafi da kuma juriya ga gajiya, wanda ya dace da molds masu zafi.
2344 (AISI P20+Ni) – Karfe mai tauri wanda ake amfani da shi wajen yin amfani da shi wajen yin amfani da shi wajen yin amfani da shi.
Waɗannan kayan suna tabbatar da tsawon rayuwar mold fiye da zagayowar 500,000, wanda ke rage farashin kayan aiki na kowane ɓangare.
- Matsalolin da ke tattare da gyaran allurar LSR
Baya ga tsarin ƙira, ƙalubalen tsari sun haɗa da:
Rufewar iska: Sassan sirara na iya kama iska, wanda hakan ke haifar da gurɓataccen iska. Sau da yawa ana buƙatar taimakon injin tsotsa.
Samuwar walƙiya: Ƙananan danko na LSR yana buƙatar madaidaicin tsari na mold da ƙarfin matsewa daidai.
Kula da maganin: Rashin warkarwa yana haifar da mannewa; danshi fiye da kima na iya haifar da karyewa. Daidaiton zafin jiki da lokacin da aka ɗauka yana da matuƙar muhimmanci.
Gudanar da kayan aiki: Dole ne a ajiye sassan LSR (A da B) a ware su sosai har sai an yi allura; dole ne a daidaita mitoci da mahaɗa daidai.
- Inganta Tsarin Gyaran Allura
Ansix Tech ta mai da hankali kan ci gaba da inganta tsari don haɓaka inganci da kuma sarrafa farashi:
Inganta sigogi: Amfani da DOE don nemo saurin allura, matsin lamba, zafin jiki, da lokacin warkewa.
Aiki da Kai: Aiwatar da cire sassan robotic, duba gani, da kuma marufi ta atomatik don rage aiki da kuma ƙara daidaito.
Rage lokacin zagayowar: Inganta zagayowar sanyaya/dumama ta hanyar ingantaccen sarrafa zafin jiki na mold.
Tanadin Kaya: Ta hanyar daidaita girman masu gudu da kuma amfani da fasahar sanyi-runner, ana rage sharar kayan.
Ingancin kuzari: Amfani da injunan allurar servo da tsarin dumama mai inganci don rage yawan amfani da wutar lantarki.
Waɗannan matakan tare suna rage farashin naúrar kowane murfin kariya, suna isar da tanadi kai tsaye ga abokan ciniki.
- Kula da Inganci da Tabbatarwa
Kowane rukuni na samarwa yana ƙarƙashin tsarin inganci mai matakai da yawa:
Duba kayan da ke shigowa: Ana tabbatar da takaddun shaida na bincike ga kowane yanki na LSR.
Dubawa a cikin tsari: Ana sa ido kan mahimman sigogi (zafin jiki, matsin lamba, lokacin zagayowar) a ainihin lokaci. Ana auna samfurori lokaci-lokaci don girma da nauyi.
Sarrafa Tsarin Lissafi (SPC): Taswirar sarrafawa tana bin diddigin mahimman ma'auni don gano duk wani motsi na tsari.
Dubawa ta ƙarshe: Dubawar gani 100% ƙarƙashin girman girma; gwaje-gwajen aiki (aikin rufewa) bisa ga samfurin samfur.
Bin diddigi: Kowane rukuni yana da alaƙa da wuraren adana kayan aiki, saitunan injina, da bayanan masu aiki, wanda ke cika buƙatun ISO 13485 don cikakken bin diddigi.
- Marufi da Tsaftacewa
Ana tsaftace sassan da aka gama kuma a naɗe su a cikin ɗakin tsafta na ISO Class 7 (Class 10,000). Ana tabbatar da kayan marufi don kula da rashin tsafta. Yawanci ana yin maganin ta hanyar amfani da ethylene oxide (EtO) ko gamma radiation, tare da ingantaccen tsarin tsaftace jiki don tabbatar da inganci ba tare da lalata silicone ba.
- Tsarin Isarwa Mai Sauri
Ansix Tech ta sauƙaƙa hanyar daga ra'ayi zuwa yawan samarwa don cika jadawalin kasuwa na gaggawa. Wannan tsarin "saurin isarwa" ya dogara ne akan:
Injiniyanci Mai Haɗaka: Zane, kwaikwayo, da shirya kayan aiki suna faruwa a layi ɗaya.
Dabaru na kayan aiki cikin sauri: Ga samfuran samfura, kayan da aka saka a cikin SLA na iya samar da sassa masu aiki cikin kwanaki.
Haɗin kai tsakanin masu samar da kayayyaki: Haɗa kai sosai da masu samar da ƙarfe, masu sayar da kayan haɗin gwiwa, da hukumomin ba da takardar shaida don guje wa jinkiri.
Tsarin samar da kayayyaki na gwaji: Tsarin samar da kayayyaki na farko yana rage haɗarin aikin kafin a samar da shi gaba ɗaya.
Wannan hanyar da ba ta da wahala tana ba Ansix Tech damar isar da kayan da aka tabbatar cikin ƙasa da makonni 8-10 bayan daskarar da ƙira.
- Kwarewar Masana'antar Ansix Tech da Jajircewar Abokin Ciniki
Tare da fiye da shekaru goma na ƙwarewa a fannin gyaran allurar LSR ta likitanci, Ansix Tech ta gina fayil ɗin ayyukan da suka yi nasara a fannoni daban-daban na hatimin tiyata, sassan catheter, da na'urorin likitanci da ake iya sawa. Injiniyoyin kamfanin sun ƙware sosai a fannin halayen LSR, ƙirar mold, da bin ƙa'idodi. Wannan zurfin gogewa yana fassara zuwa ƙarancin maimaita ƙira, ƙarancin haɗarin jinkiri na aiki, kuma a ƙarshe, hanyar samar da kayayyaki mafi aminci ga abokan ciniki.
Abu mafi mahimmanci, Ansix Tech ta himmatu wajen rage jimillar farashin mallakar abokan ciniki. Ana cimma wannan ba ta hanyar yin amfani da fasahar zamani ba, sai ta hanyar injiniya mai wayo:
Zaɓin Kayan Aiki: Ba da shawarar matakin LSR mafi inganci wanda ya cika duk sharuɗɗan aiki.
Inganta tsari: Inganta yawan amfanin ƙasa da rage lokacin zagayowar don rage farashin kowane ɓangare.
Inganta inganci: Ana sarrafa ayyukan bayan gyaran fuska ta atomatik da kuma aiwatar da ƙa'idodin masana'antu masu laushi.
Ta hanyar mai da hankali kan waɗannan matakan, Ansix Tech ta rage farashin yawancin kayan aikin ba tare da yin illa ga inganci ba - wani ra'ayi mai mahimmanci wanda ke da tasiri sosai a kasuwannin kiwon lafiya masu la'akari da farashi.
Kammalawa
Tafiyar murfin kariya na silicone mai ruwa daga buƙatar tiyata zuwa na'urar likita da aka samar da ita da yawa, shaida ce ta haɗin gwiwar injiniyanci mai zurfi, tsarin inganci mai tsauri, da kuma ƙwarewar kayan aiki mai zurfi. Ansix Tech ta misalta yadda abokin hulɗa mai ƙera allura zai iya sarrafa wannan yanayi mai rikitarwa, yana samar da wani ɓangare wanda ya cika mafi girman ƙa'idodi na aiki, aminci, da araha. Yayin da tiyata mai ƙarancin mamaye ke ci gaba da bunƙasa, rawar da gyaran LSR daidai zai yi girma kawai - kuma tare da ingantaccen tarihin sa, Ansix Tech tana shirye ta ci gaba da zama abokiyar aminci ga masu ƙirƙira kayan aikin likita a duk duniya.
Kamfanin Ansix Tech Ltd
Idan kuna da wasu tsare-tsare da suka shafi murfin kariya na silicone na ruwa don yanke trocar na laparoscopic, kuna iya tuntuɓar mu a kowane lokaci. Za mu mayar da ra'ayoyinku su zama gaskiya, mu bar ku ku cika burinku, kuma mu sami manyan oda daga kasuwa. Bayanan tuntuɓar mu sune info@ansixtech.com. Ko kuma ku tuntuɓi CTO ɗinmu, ta imel: stephen@ansixtech.com
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