Yuav Ua Li Cas Menghini Needle Achieves Stylet -Seal Integrity

CovMenghini koobtshwm tsuas yog marginally nyuaj tshaj li ib koob hypodermic - sab nraud cannula + puab stylet + syringe connector, peb daim. Txawm li cas los xij nws txoj kev tsim khoom nyuaj zais qhov tseeb hauv qhov haum ntawm peb yam khoom no: cov lus qhia stylet yuav tsum zoo kawg nkaus kaw lub sab hauv bevel qhib yam tsis tau nruj kom lub tshuab nqus tsev vacuum thaum lub sij hawm aspiration; lub bevel yuav tsum tau txiav symmetrically, txwv tsis pub cov ntaub so ntswg yuav shear ntawm lub kaum sab xis; lub puab lumen yuav tsum du txaus uas fragmented cov ntaub so ntswg strips yuav extruded. Cov lus qhia muab los ntawm cov tuam txhab xws li Manners Technology-5-axis laser, ISO 13485, electropolishing + ultrasonic tu, BOM cov ntaub ntawv pov thawj-daim ntawv qhia raws nraim rau cov kev cai no.

5-Axis Laser Bevel Txiav

Ib txwm hypodermic bevels yog hauv av ntawm lub log abrasive, tab sis Menghini bevels muaj ob qhov kev xav tau ntxiv:

Lub kaum sab xis yuav tsum ruaj khov 20℃-25℃(kev kam rau siab ± 1 degree) thiab ob sab sib luag; txwv tsis pub rab koob yuav "yaw" thaum lub sij hawm ntxig.

Lub ntug sab hauv ntawm lub bevel yuav tsum tsim ib "micro- hniav"-Menghini qhov txiav txiav yog nyob ntawm sab hauv qab ntug ntawm lub bevel, tsis yog sab nraud cannula tua. Qhov ntse ntawm cov hniav sab hauv no ncaj qha txiav txim siab seb cov ntaub so ntswg puas huv si huv si. 5- axis laser tso cai rau lub ntsej muag bevel + puab lub vojvoog kom tiav hauv ib qho dhau los, nrog lub tshav kub me dua - thaj tsam cuam tshuam ntau dua 3- axis lasers, thiab tsis muaj cov micro-serrations sab laug los ntawm kev sib tsoo log (uas ua rau cov ntaub so ntswg extrusion).

Stylet-rau- Lumen Seal Integrity

Qhov no yog qhov tsis pom zoo tshaj plaws ntawm Menghini manufacturing. Lub taub hau stylet yog tiaj- taub hau micro-convex; Thaum muab tso rau hauv lub cannula sab nrauv, nws yuav tsum kaw lub bevel qhib - tiv thaiv cov ntaub so ntswg subcutaneous los ntawm kev nkag mus rau lumen thaum lub sij hawm tso. Thaum tso tseg, tus kws kho mob thim rov qab cov stylet 1-2 hli (qee qhov kev tsim rov qab mus rau qhov txwv tsis pub), qhib qhov chaw nres nkoj bevel rau lub tshuab nqus tsev.

Lub foob kam rau ua feem ntau yog: puab lumen ID − stylet OD=0.02–0.04 mm. loj heev=tsis zoo foob; me heev=jamming. Cov chaw tsim khoom hauv tsev muaj peev xwm ntawm kev hloov pauv hloov tau ruaj khov yog cov ntsiab lus ntawm Yangzhou / Changzhou tier uas mastered hypodermic nyias-phab ntsa kos duab- Cov cwj pwm yog ntawm cov uas 串联 (kev koom ua ke) peb txheej txheem: "CNC tig ntawm stylet + laser raj txiav + electropolishing."

Electropolishing + Ultrasonic Ntxuav

Qhov kev xav tau ntawm cov phab ntsa sab hauv kom zoo rau cov koob Menghini yog qhov kev txiav txim siab ntau dua li cov koob txhaj tshuaj: cov ntaub so ntswg yuav tsum tsis txhob "dai" ntawm phab ntsa thaum lub sij hawm extrusion. Electropolishing txo cov phab ntsa sab hauv Ra los ntawm 0.4 μm mus rau 0.1-0.15 μm, ua raws li kev ntxuav ultrasonic (+ cov dej ntshiab yaug + particle suav) kom ua tau raws li qhov ntau dua lossis sib npaug ntawm 10 μm feem ntau txwv. ISO 13485 tsis yog ornamental ntawm no-Tsab hnub poob OEM kev tshuaj xyuas tsis tu ncua xyuas peb lub cav: "electropolish da dej concentration cov ntaub ntawv + ultrasonic tu ncua sij hawm + kev soj ntsuam feem ntau zaus."

BOM Cov ntaub ntawv pov thawj

Menghini koob raj feem ntau siv 304 lossis 316L kev kho mob stainless hlau (304 txaus; 316L tau teev tseg rau kev txiav txim siab nrog cov ntshav sib txuas); stylets siv tib yam khoom; hubs siv kho mob PP. Cwj pwm cov lus "Muab daim ntawv pov thawj khoom siv rau txhua yam khoom hauv BOM" txhais tau hais tias rab koob raj coil, stylet bar Tshuag, thiab hub resin yuav tsum txhua tus tuaj yeem taug qab kom yaj cov lej batch -qhov no yog daim pib nkag rau FDA / EU MDR xaj; Yog tsis muaj nws, Western hom tswv yuav tsis ntxiv koj rau lawv cov npe khoom.

🛠 Chaw tsim tshuaj paus:​ Margins on Menghini needles don't come from "tube drawing" (any hypodermic factory can do that)-they come from yield rates on the three processes: "stylet seal integrity + laser bevel + electropolishing." Factories achieving stylet Cpk >1.33 hais kom ua 8-12% rau -cov nqi them los ntawm Western OEMs, vim tias 70% ntawm cov lus tsis txaus siab rov qab mus rau "stylet jam" lossis "tsis ua haujlwm."