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Kev tsim cov koob txhaj tshuaj subcutaneous pov tseg yog qhov ua tiav ntawm qhov tseebtshuab, cov ntaub ntawv tshawb fawb, thiab kev tswj kom zoo. Tag nrho cov kab ntau lawm ua haujlwm raws li ob tus qauv ntawm ISO 13485 thiab GMP, nrog rau kev ua kom huv huv mus txog qib ISO 7 (tus naj npawb ntawm cov khoom ntau dua lossis sib npaug ntawm 0.5 μm hauv txhua lub cubic meter ntawm huab cua yuav tsum tsis pub tshaj 352,000). Cov txheej txheem pib nrog stainless hlau sawb cov ntaub ntawv, nrog ib tug tuab ntawm 0.3 - 0.5 hli, thiab undergoes ntau tshaj 20 ua cov kauj ruam los hloov mus rau hauv tiav koob taub hau. Lub sijhawm ua haujlwm tag nrho yog 12 - 15 feeb, thiab cov kab ntau lawm tuaj yeem ncav cuag 300 - 500 koob ib feeb.

Txoj kev tsim cov yeeb nkab siv cov txheej txheem ntau- theem sib sib zog nqus. Cov ntaub ntawv thawj zaug yog stamped rau hauv ib lub yeeb nkab uas muaj txoj kab uas hla ntawm 8 hli. Tom qab ntawd, nws tau txuas ntxiv mus rau hauv tungsten-carbon alloy pwm, nrog rau txhua txoj kev kos duab ua rau 15-20% txo rau hauv qhov hla- ntu ntu. Intermittent ci annealing (nyob rau hauv kev tiv thaiv hydrogen, ntawm qhov kub ntawm 1050-1150 degree) yog ua nyob rau hauv nruab nrab. Los ntawm 10th txheej txheem kos duab, txoj kab uas hla yog txo mus rau 1.2 hli thiab phab ntsa thickness yog 0.15 hli. Ntawm no, thawj electrolytic polishing yog ua los tshem tawm cov txheej txheem deg ntawm 5-8 μm. Nyob rau theem kawg ntawm kev kos duab micro-tube, polycrystalline pob zeb diamond pwm yog siv, nrog aperture kam rau ua ntawm ± 1 μm thiab qhov roughness ntawm Ra tsawg dua lossis sib npaug li 0.05 μm. Qhov no theem ntawm precision ua kom lub laminar ntws yam ntxwv ntawm cov kua tshuaj thiab txo cov turbulence los ntawm 40%.

Cov txheej txheem sib tsoo yog qhov tseem ceeb ntawm kev siv tshuab. Peb -Nto koob taub yuav tsum tau ua tiav ntawm peb qhov kev sib tsoo tshuab ua ntu zus: thawj kauj ruam yog kev sib tsoo ntxhib los ua lub ntsiab inclined nto (lub kaum sab xis 15-}20 degree), nrog lub log sib tsoo loj ntawm 400# thiab linear ceev ntawm 25-30 m / s; cov kauj ruam thib ob yog kev sib tsoo zoo rau qhov chaw nruab nrab inclined (12{14}}15 degree), nrog rau qhov loj me ntawm 800#; Cov kauj ruam thib peb yog kev sib tsoo zoo heev los tsim cov kab txiav ntug, nrog rau qhov loj me ntawm 2000 # thiab txiav ntug band dav ntawm 0.03-0.05 hli. Qhov tseeb tsib-nto koob lub taub hau ntxiv ob txheej txheem ntxiv: theem plaub yog sib tsoo qhov kev hloov pauv nkhaus (khoov vojvoog 0.1-0.2 hli), thiab theem thib tsib yog polishing ntug txiav, ua rau lub vojvoog arc ncav cuag 0.5-1 μm, tsuas yog ib feem kaum ntawm txoj kab uas hla ntawm cov ntshav liab. Cov qauv no txo ​​cov puncture quab yuam los ntawm ib txwm koob ntawm 1.8 N txog 0.8 N.

Laser micromachining yog revolutionizing tsim cov lus qhia koob. Femtosecond laser (wavelength 1030 nm, mem tes dav 350 fs, lub zog 20 W) ncaj qha rau ntawm rab koob kawg lub ntsej muag los ntawm ablation, nrog qhov tsawg kawg nkaus feature loj ntawm 5 μm thiab lub kaum sab xis ntawm ± 0.5 degree. Piv nrog rau kev sib tsoo tshuab, kev ua laser tsis muaj cov cuab yeej hnav, thiab qhov sib xws tau txhim kho los ntawm 50%, thiab nws tuaj yeem ua cov txheej txheem nyuaj xws li micro hooks (rau cov ntaub so ntswg anchoring) lossis sab qhov (rau diffusion txhaj). Dej- coj laser tshuab txuas ntxiv txo cov cua sov hauv cheeb tsam, txo cov thermal puas txheej los ntawm ib txwm laser lub 10-20 μm rau 2-3 μm, thaum tswj cov khoom qub txhua yam ntawm cov khoom.

Kev tswj ntawm cov txheej txheem silicon txheej txiav txim siab cov neeg siv kev paub. Cov txheej txheem dip txheej txheej ua rau cov roj silicon tuab ntawm 1-3 μm, tab sis nws muaj qhov tsis sib xws (nrog rau qhov sib txawv ntawm 15-20%). Tus tshiab plasma-enhanced chemical vapor deposition method generates ib pob zeb diamond zoo li carbon zaj duab xis nrog ib tug tuab ntawm 50-100 nm ntawm lub koob raj nto, nrog kev sib txhuam coefficient ntawm 0.08-0.12, thiab tsis tas yuav tsum tau cov roj silicon, tshem tawm cov kev tsis haum tshuaj uas tshwm sim los ntawm silicon roj me me ntawm 5. Kev tswj xyuas zoo hauv online siv lub teeb dawb interferometer coj mus kuaj thiab kuaj cov txheej tuab (yuav tsum tau 50 ± 5 nm) thiab lub zog saum npoo (yuav tsum tsawg dua lossis sib npaug li 25 mN / m) txhua 10 feeb.

Automated los ua ke ua tiav millimeter -qib precision alignment. Kev sib txuas ntawm cov koob txhaj tshuaj thiab lub koob txhaj tshuaj yog sib koom ua ke siv UV-cov nplaum nplaum, nrog rau qhov ntim ntawm qhov ntim ntawm 0.8 txog 1.2 mg, thiab qhov kev xav tau sib txawv yog tsawg dua lossis sib npaug li 0.05 hli. Lub teeb pom kev zoo (5 lab pixels, daws teeb meem 5 μm) kuaj pom tus nqi thiab txoj haujlwm ntawm cov nplaum nyob rau lub sijhawm, thiab tsis lees paub cov khoom tsis raug. Cov txheej txheem kub riveting siv siab - zaus induction cua sov (frequency 400 kHz, fais fab 2-3 kW, sij hawm 0.3-0.5 vib nas this) rau ib nrab plasticize lub koob yas dhos, thiab qhwv lub koob txhaj tshuaj nyob rau hauv ib tug siab ntawm 30-50 N 5 axis yuav tsum tau rau lub zog sensor. saib xyuas lub riveting quab yuam nkhaus thiab txheeb xyuas qhov tsis xws luag.

Txoj kev ua kom tsis muaj menyuam yog qhov kev tiv thaiv zaum kawg rau kev nyab xeeb lom neeg. Cov txheej txheem tsis haum rau ethylene oxide sterilization yog: concentration ntawm 600 ± 30 mg / L, kub ntawm 50 ± 2 degree, txheeb ze av ntawm 60 ± 10%, thiab raug lub sij hawm ntawm 180 feeb. Cov hluav taws xob hluav taws xob tawm kom tsis muaj menyuam (nrog lub zog ntawm 10 MeV thiab ib koob ntawm 25 - 40 kGy) muaj zog nkag mus, thiab lub sijhawm ua haujlwm tsuas yog 30 vib nas this, tsis muaj tshuaj lom neeg, tab sis nws yog xaiv rau cov khoom ntim. Kev kuaj aseptic siv cov txheej txheem membrane pom. Rau txhua batch, 200 cov qauv raug coj mus kuaj thiab coj mus rau hauv peptone soy broth rau 14 hnub. Yuav tsum tsis muaj kev loj hlob ntawm microbial.

Tag nrho -txheej txheem txheej txheem kev tswj xyuas (SPC) ua kom muaj qhov zoo sib xws. Tiag - lub sij hawm saib xyuas ntawm qhov tseem ceeb tsis: lub kaum sab xis CPK yog ntau dua los yog sib npaug rau 1.67, lub puab kab uas hla CPK yog ntau tshaj los yog sib npaug rau 1.33, thiab puncture quab yuam CPK yog ntau dua los yog sib npaug rau 1.50. 100% lub tshuab tsis pom kev tshuaj xyuas yog them, thiab cov khoom kuaj xyuas muaj xws li: 10 lub cev tsis zoo, μ thiab luam ntawv cim kev ncaj ncees. Qhov kev ntsuas quab yuam simulates cov ntaub so ntswg tiag (10% gelatin, hardness 25-30 Shore A), nrog rau tus qauv: 30G koob puncture force 0.8-1.2 N, 27G koob 1.2-1.8 N, nrog cov coefficient ntawm kev sib txawv tsawg dua lossis sib npaug li 10%. Kev ntsuas cov cuab yeej txhua xyoo tau txais tus qauv koob ntsuas (ISO 7864 tus qauv), kom ntseeg tau tias qhov ntsuas qhov ua yuam kev yog <2 μm.