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Vashambadziri vanofananidza vatengesi vekeji vanotarisa kutarisa PEEK giredhi uye mutengo payuniti, wozofunga kuti mamwe anogona kuchinjika. Hazvisizvo. A TLIF kana PLIF keji idiki, geometrically yakaoma mudziyo unofanirwa kuwana zvinhu zvakati wandei kamwechete - tsoka, kureba, lordotic angle, endplate mazino pateni, graft hwindo vhoriyamu, inopinza interface, uye yekuisa chiratidzo - uye kuwana chero ipi zvayo isiriyo inoratidzwa muOR, kwete pane imwe pepa.
Iri igwara rinoshanda rekuongorora iyo China-yakavakirwa TLIF/PLIF keji inogadzira yakapfuura zvinhu uye mutengo kuenzanisa vazhinji vanogovera vanotanga nazvo.
Zviri nyore kufunga nezvekeji yemukati sechidimbu chakaumbwa chePEEK kana titanium ine mamwe maburi akachekwa mairi. Mukuita, chiyero chega chega isarudzo yekugadzira ine mhedzisiro yekiriniki:
Footprint - idiki zvakanyanya uye keji inokanganisa kudzikira mu vertebral endplate; yakakura kwazvo uye haigare zvakanaka kuburikidza neTLIF corridor pasina kudzoreredza zvakanyanya
Kureba - inoda huwandu hwakakwana mudiki increments (kazhinji 1mm nhanho) kudzoreredza kureba kwedisiki pasina kunyanya-kukanganisa chikamu.
Lordotic angle - makeji akadzikama haadzorere sagittal kurongeka; mugadziri anopa kona imwe chete sarudzo pakukura kwavo kwese kwehukuru haisi kunyatso kupa inoshandisika sisitimu yeakasiyana anatomy
Endplate mazino - iyo ridged yepamusoro peteni inopesana nekeji kutama mushure mekuiswa; kureba kwezino uye kona inobata zvose kugadzirisa kwekutanga uye nyore kwekubvisa munyaya yekudzokorora
Graft hwindo - nzvimbo yakazaruka yemapfupa ekubatanidza zvinhu; diki zvakanyanya uye fusion nzvimbo inokanganiswa, yakakura kwazvo uye kurongeka kwekeji pachayo kunoderedzwa.
Inserter interface - kuti keji inokiya sei pachiridzwa chekuisa panguva yekuiswa
Radiopaque mamaki - kazhinji mapini etantalum, anoshandiswa kusimbisa nzvimbo yekeji uye kutaridzika pasi pefluoroscopy sezvo PEEK pachayo iri radiolucent.
Mugadziri anogona kutaura nemadimendi aya chaizvo - kwete chete 'tinopa masaizi akawanda' - ndiye anotonzwisisa zvavanenge vachigadzira kwete kungomhanyisa chirongwa cheCNC vachipesana nedhirowa yakapihwa mumwe munhu.
Vashambadziri vanowanzobvunza kuti ndezvipi zvinhu 'zvirinani.' Hausi mubvunzo une mhinduro imwechete - zvinoenderana nezvinodiwa nachiremba, danho chairo riri kusanganiswa, uye zvinodikanwa zvekufungidzira - saka nzira inobatsira ndeyekuenzanisa izvo mugadziri anogona kunyora nezvechinhu chimwe nechimwe pane kusarudza divi.
Zvinyorwa zvezvinhu - zvePEEK, izvi zvinoreva kusimbisa yehutano-giredhi PEEK pasina kabhoni fiber reinforcement (carbon-fiber PEEK yakasimba asi inovharidzira kufungidzira, iyo inokosha pa postoperative fusion assessment); yetitanium, izvi zvinoreva iyo chaiyo alloy giredhi uye ingave yakasimba kana 3D-yakadhindwa porous chimiro.
Kufungidzira maitiro - PEEK ine radiolucent, iyo inobvumira vanachiremba vanovhiya kuti vaongorore fusion kufambira mberi pakufungidzira kwekutevera pasina cage inovhara maonero; titanium inonzi radiopaque, iyo vamwe vanachiremba vanovhiya vanosarudza kusimbisa nzvimbo yekeji asi iyo inogona kuita kuti kuongorora kukura kwefupa kuburikidza nekeji kuome.
Dhizaini yepamusoro - yakatsetseka PEEK ine bioinert pamusoro iyo isingashingairi kukurudzira bhonzo-pa-kukura; mavara kana porous titanium nzvimbo (kusanganisira 3D-yakadhindwa trabecular zvimiro) zvakagadzirirwa kukurudzira osseointegration yakananga painosimwa pamusoro.
Mechanical zvinodiwa - zvese zvishandiso zvinoda kusangana ne static uye inosimba yekumanikidza yekuyedza zviyero zvemidziyo yemukati, asi iyo inogamuchirwa dhizaini migero inosiyana nekuoma kwezvinhu.
Zvaunoda kubva kumugadziri zvinyorwa pamitsetse miviri yemidziyo, kwete nzvimbo yekutengesa kune chero yavanenge vagadzira yakawanda.
Sezvo makeji ePEEK asingaratidzike zvakajeka pafluoroscopy, mamaki etantalum akaiswa mukeji ndiyo chete chaiyo-yenguva simbiso yekeji yenzvimbo uye kutaridzika kwekeji panguva yeTLIF kana PLIF nzira - mukoto une kushomeka kwekuona zvakananga. Kana iwo mamarks agara asingawirirani, kana kutama panguva yekubata, chiremba anovhiya anorasikirwa nekuvimba mune izvo C-ruoko ruri kuratidza.
Takafukidza izvi zvakadzama mu Nei Radiopacity Inobata muTLIF Cages , kusanganisira mufananidzo chaiwo wekuvhiya chiremba anovhiya akatumira achiratidza chiratidzo chechiratidzo panguva chaiyo. Zvakakodzera kuverenga padivi pegwaro iri, nekuti rinoratidza kuti 'chakanaka zvakakwana' chekuiswa kwemucherechedzo chinotaridzika sei pane mhenyu fluoroscopy monitor - kwete chete mune yakatarwa sheet claim.
Iyi ndiyo yekukundikana kwevanogovera vanonzwa nezve yakaderera kazhinji pane yemhando yemhando, asi inokonzeresa mamwe epakati-kesi matambudziko. Iyo inopindirana pakati pekeji uye inoipinza inofanirwa kubatirira pasi pekudzokororwa kudzokororwa - mallet anorovera achigadzika keji munzvimbo ye disc - pasina kusunungura kana kukanganisa.
Chii chekutarisa chaizvo:
Inserter yekuvhara michina - yakarukwa, ine kiyi, kana friction-fit - uye kuti inobata zvakachengetedzeka kuburikidza neakazara maitiro anotevedzana.
Cage orientation simbiso - chiremba anovhiya anogona kuudza nzira iyo keji yakatarisana nayo kana yatakurwa pane inopinza, kunyanya mukoridho umo kuona kwakananga kunogumira.
Impaction kushivirira - iyo cage-inserter yekubatanidza inomira pasi pesimba chairo rekuita, kana kuti inoda kubata zvinyoro-nyoro izvo zvinononotsa chiremba anovhiya pasi
Dimensional consistency - ndiyo inopinza interface yakagadzirwa kune imwechete yekushivirira keji mushure mekeji, batch mushure mebatch, kana inokwana inosiyana zvekuti mamwe mayuniti anonzwa akasununguka kupfuura mamwe.
Chiridzwa chinofananidzwa - mugadziri anopa chinopinza sechikamu chesisitimu yakasimbiswa nekeji, kana kuti chiridzwa chegeneric chinoitika kuti chikwane.
Keji inosangana nechero dimensional spec pabepa asi inopatsanurwa kubva kune yayo yepakati-impaction haisi diki kukanganisa - inyaya yakamiswa ine disc nzvimbo yakatogadzirwa uye murwere ari pasi peanesthesia.
Kana zvinhu uye mekiniki interface yasimbiswa, mubvunzo unotevera ndewekuti saizi chaiyo yemugadziri uye yekumisikidzwa inovhara izvo zvinodiwa nevanovhiya vako:
Straight vs. curved footprints - makeji akakombama akajairika kuPLIF (bilateral placement) nepo TLIF inowanzoshandisa dhizaini yakaita sebhanana kana itsvo inokodzera kuiswa unilateral.
Huremu renji - kazhinji 8-14mm mu 1mm increments ye lumbar application, inovhara huwandu hwema disc marefu akasangana.
Lordotic angle sarudzo - padiki chiyero uye hyperlordotic sarudzo (kazhinji 0 °, 6 °, uye yepamusoro kune zvikamu zvinoda mamwe sagittal kururamiswa)
Footprint hupamhi uye kureba - mutsauko wakakwana kuti uenderane neakasiyana vertebral saizi yemuviri pasina kumanikidza imwe-saizi kuwirirana.
TLIF / PLIF / MIS kuenderana - ingave iyo imwe keji chikuva chinoshanda munzira dzakavhurika uye shoma shoma, kana kuti kuiswa kweMIS kunoda yakasarudzika dhizaini yekeji uye yekuisa system.
Mutsara wakamanikana unomanikidza timu yako yekutengesa kuti isangane nevarapi vepakati-kukurukurirana - kuvaudza saizi yepedyo iripo ndeye 'pedyo zvakakwana' pane kunyatso fananidza izvo zvinodaidzira.
Usati waita inventory, kumbira:
TS EN ISO 13485 scope annex - inosimbisa interbody fusion makeji zviri pachena mukati meiyo yakasimbiswa chiyero, isingafungidzirwe pasi pechikamu chemuzongoza.
Zvitupa zvezvinhu - PEEK resin lot certification inosimbisa giredhi rekurapa uye kusavapo kwekabhoni fiber kusimbisa (kunze kwekunge kabhoni-fiber PEEK iri chaizvo iri kurairwa); titanium mill certs inopesana neyakakodzera ASTM standard
Dimensional yekuongorora marekodhi - CMM yekuongorora pane tsoka, kureba, uye mucherechedzo chiteshi kushivirira, kwete kungoongorora-chinyorwa chekutanga asi kuenderera mberi kwekugadzira sampling.
Mechanical yekuyedza mishumo - yakamira uye ine simba yekumanikidza-kugera kuyedzwa paASTM F2077 kana yakaenzana kune epakati midziyo.
Traceability uye batch marekodhi - inogona chaiyo keji kurondwa kumashure kune yayo yekugadzira yakawanda uye yakabikwa zvinhu batch mwedzi mushure mekutumira
Kune vanogovera vanoongorora interbody fusion cage sarudzo kune vese vatengesi, vachienzanisa zvinyorwa izvi neizvo chaizvo interbody fusion cage tsanangudzo uye PEEK cage chigadzirwa mitsara padivi padivi inzira yakavimbika yekuongorora pane kuenzanisa zvikumbiro zvekushambadzira.
Makeji emukati anotakura matrix akasarudzika - tsoka dzakawanda, kureba kwakawanda, akawanda lordotic angles - zvinoreva kuti hesiti yemugovera inofanirwa kuvhara nzvimbo yakawanda kudzivirira kufona kuchipatara kwehukuru husiri pasherufu. Yakajairwa catalogue cage masisitimu anochengetedzwa pakuvharirwa kwepamusoro, nekutakura-mu-stock kazhinji mukati memazuva matatu ebhizinesi, kuderedza kusawirirana kwegeji rehukuru kuve dambudziko rekuronga.
Rutsigiro rweOEM yemakeji masisitimu kazhinji inovhara kurongedza uye kunyora manyorero, dhizaini kumisikidzwa nemusika, uye zvinyorwa zvinotsigira kunyoreswa kwenzvimbo - izvi zvinokurumidza kuita. Iyo chaiyo nyowani kage geometry kana tsoka, nekupesana, inoda kusimbiswa kwedhizaini uye yakagadziridzwa mekinika kuyedzwa isati yatakura, uye iyo nguva inofanirwa kutaurirwa zvakajeka kwete kupenya.
Evaluation Point |
Chekutarisa |
|---|---|
Dhizaini Dzinokosha |
Footprint, kureba kuwedzera, lordotic angle range, endplate mazino pateni, graft hwindo |
Material |
PEEK giredhi (carbon-fiber-isina yakasimbiswa) kana titanium alloy / porous chimiro, ine zvitupa |
Marker Placement |
Tantalum mucherechedzo chiteshi kushivirira uye kuenderana pasi pe fluoroscopy |
Inserter Interface |
Kukiya meshini, kushivirira kwekuita, dimensional consistency batch kune batch |
Product Range |
Yakatwasuka/yakakombama tsoka, kureba kwakazara uye lordotic angle sarudzo, TLIF/PLIF/MIS kuenderana |
Zvinyorwa |
ISO 13485 chiyero, zvitupa zvezvinhu, chiyero chekuongorora, mechanic kuyedzwa, traceability. |
Delivery & OEM |
Inventory yekuvhara mukati mehukuru matrix, inotungamira nguva yekutungamira, yakajeka chiyero chekugadzirisa |
Iyo certification uye yekugadzira chirango mibvunzo pano inotevera pfungwa imwechete yakafukidzwa mukutarisa kwedu kwakafara China vs. US spine vagadziri - chii chinoparadzanisa akavimbika cage supplier kubva kune ine njodzi yakanyorwa maitiro ekudzora, kwete uko fekitori inoitika kugara pamepu.
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