Uyivavanya njani iTLIF ​​kunye nePLIF Cage Manufacturer eTshayina

Abasasazi abathelekisa ababoneleli ngekheji ye-interbody badla ngokujonga ibakala le-PEEK kunye nexabiso ngeyunithi nganye, emva koko bacinge ukuba okuseleyo kunokutshintsheka. Akunjalo. Ikheji ye-TLIF okanye i-PLIF sisixhobo esincinci, esintsonkothileyo sejometri ekufuneka sifumane izinto ezininzi kanye kanye - unyawo, ukuphakama, i-angle ye-lordotic, ipateni yamazinyo e-endplate, ivolumu yefestile yegrafti, i-interface yokufaka, kunye nokubekwa komakishi - kunye nokufumana nayiphi na enye engalunganga ibonisa kwi-OR, kungekhona kwiphepha elithile.

Esi sisikhokelo esisebenzayo sokuvavanya i-TLIF / PLIF yomvelisi wekheji yaseTshayina edlulileyo kwizinto eziphathekayo kunye nothelekiso lwamaxabiso uninzi lwabasasazi luqala ngalo.

Ikheji ayisiyonto nje i-PEEK Block

Kulula ukucinga ngekheji ye-interbody njengeqhekeza elimile le-PEEK okanye i-titanium enemingxuma ethile esikwe kuyo. Ngokwesiqhelo, imilinganiselo nganye sisigqibo soyilo esinesiphumo seklinikhi:

• I-Footprint - encinci kakhulu kwaye i-cage ibeka ingozi kwi-subsidence kwi-endplate ye-vertebral; inkulu kakhulu kwaye ayizukuhlala ngokufanelekileyo kwipaseji ye-TLIF ngaphandle kokurhoxa kakhulu

• Ubude - bufuna uluhlu olwaneleyo lokunyuswa okuncinci (ngokuphindaphindiweyo amanyathelo angama-1mm) ukubuyisela ubude bediski ngaphandle kokuphazamisa kakhulu icandelo.

• I-angle ye-Lordotic - iikheji ezisicaba azibuyisi ulungelelwaniso lwesagittal; umenzi obonelela nge-engile enye kuphela kuluhlu lwabo bonke lobungakanani akaboneleli ngenkqubo esebenzisekayo ye-anatomy eyahlukeneyo

• Amazinyo e-Endplate - ipateni yendawo edibeneyo echasene nokufuduka kwe-cage emva kokubekwa; ukuphakama kwezinyo kunye ne-angle kuchaphazela kokubili ukulungiswa kokuqala kunye nokukhululeka kokususwa kwimeko yokuhlaziya

• Ifestile yegrafti - indawo evulekileyo yezinto ezixutywe ngamathambo; incinci kakhulu kwaye indawo yomphezulu wodibaniso isengozini, inkulu kakhulu kwaye imfezeko yolwakhiwo lwekheji ngokwayo iyancitshiswa.

• Ujongano lokufakela — indlela ikheji itshixa ngayo kwisixhobo sofakelo ngexesha lokubekwa

• Iimpawu zeRadiopaque - izikhonkwane eziqhelekileyo ze-tantalum, ezisetyenziselwa ukuqinisekisa indawo yekheji kunye nokuqhelaniswa phantsi kwe-fluoroscopy kuba i-PEEK ngokwayo ine-radiolucent.

Umvelisi onokuthetha ngale milinganiselo ngokukodwa - hayi nje 'sinika iisayizi ezininzi' - ngumntu oyiqondayo into abayivelisayo kunokuba aqhube inkqubo ye-CNC ngokuchasene nomzobo onikezelwe ngomnye umntu.

PEEK vs. Titanium: Yintoni omawuyithelekise

Abasasazi basoloko bebuza ukuba yeyiphi imathiriyeli 'engcono.' Lowo ayingombuzo onempendulo enye - kuxhomekeke kukhetho logqirha wotyando, inqanaba elithile elidityanisiweyo, kunye neemfuno zemifanekiso - ngoko ke eyona ndlela iluncedo kukuthelekisa oko umenzi anokubhala malunga nemathiriyeli nganye kunokuba akhethe icala.

• Amaxwebhu ezinto eziphathekayo - kwi-PEEK, oku kuthetha ukuqinisekiswa kwe-PEEK yonyango ngaphandle kwe-carbon fiber reinforcement (i-carbon-fiber PEEK inamandla kodwa ifihla i-imaging, eyona nto ibalulekileyo kuvavanyo lwe-fusion emva kokusebenza); ye-titanium, oku kuthetha udidi oluthile lwengxubevange nokuba luqinile okanye luprintwe nge3D

• Iimpawu zokubonisa - i-PEEK i-radiolucent, evumela oogqirha botyando ukuba bahlole inkqubela ye-fusion kwi-imaging yokulandelela ngaphandle kwe-cage efihla umbono; I-titanium yi-radiopaque, abanye oogqirha botyando bakhetha ukuqinisekisa indawo yekheji kodwa enokwenza uvavanyo lokukhula kwethambo ngekheji ibe nzima.

• Uyilo lomphezulu - iPEEK egudileyo inomphezulu webioinert ongakhuthazi ukukhula kwamathambo; imiphezulu ye-titanium eyenziweyo okanye eneporous (kubandakanywa ne-3D-printed trabecular structures) iyilelwe ukukhuthaza i-osseointegration ngqo kumphezulu wokufakelwa.

• Iimfuno zoomatshini - zombini izixhobo kufuneka zihlangabezane nemigangatho yovavanyo yoxinzelelo olusisigxina kunye noluguquguqukayo lwezixhobo ze-interbody, kodwa imida yoyilo eyamkelekileyo iyahluka ngokuqina kwezinto.

Into oyifunayo kumvelisi ngamaxwebhu kuyo yomibini imigca yemathiriyeli, hayi indawo yokuthengisa nokuba yeyiphi na abayenzayo ukuvelisa ngaphezulu.

Kutheni iRadiopaque Marker Placement ibalulekile ngokwenene

Kuba iikheji ze-PEEK zingabonakali ngokucacileyo kwi-fluoroscopy, iimpawu ze-tantalum ezifakwe ekhejini kuphela koqinisekiso lwexesha lokwenyani lwendawo yekheji kunye nokuqhelaniswa ne-TLIF okanye inkqubo ye-PLIF - ipaseji enombono othe ngqo olinganiselweyo. Ukuba abo bamakishi bahlala ngokungahambi kakuhle, okanye bafuduke ngexesha lokuchaphazeleka, ugqirha ulahlekelwa yintembelo kwinto eboniswa yi-C-arm.

Sikugubungela oku ngokweenkcukacha ezithe vetshe kwi Kutheni i-Radiopacity ibalulekile kwi-TLIF Cages , kubandakanywa nomfanekiso wangempela we-intraoperative ugqirha othunyelwe ebonisa ukubonwa kophawu ngexesha lemeko yangempela. Kufanelekile ukufunda ecaleni kwesi sikhokelo, kuba sibonisa ukuba 'ukulunga ngokwaneleyo' ukubeka uphawu kujongeka njani kwimonitha ephilayo ye-fluoroscopy - hayi nje kwibango lephepha elithile.

I-Cage kunye ne-Inserter Compatibility

Eli linqaku lokusilela abasasazi beva malunga nexesha elingaphantsi kakhulu kunomgangatho wezinto eziphathekayo, kodwa kubangela iingxaki ezingakumbi zemeko ephakathi. I-interface phakathi kwe-cage kunye nomfaki wayo kufuneka ibambe phantsi kwempembelelo ephindaphindiweyo - i-mallet ibetha ihlalisa i-cage kwi-disc space - ngaphandle kokukhulula okanye ukungahambi kakuhle.

Yintoni omawuyiqwalasele ngokuthe ngqo:

• Umtshini wokutshixa - uthungelwe, ufakwe isitshixo, okanye ukukhuhlana-kwaye nokuba ibambe ngokukhuselekileyo kulandelelwano olupheleleyo lwempembelelo

• Isiqinisekiso sokuqhelaniswa nekheji — ngaba ugqirha unokuxela ukuba ikheji ijonge kweyiphi na indlela xa sele ilayishiwe kwisifakeli, ngakumbi kwipaseji apho ukubonwa okuthe ngqo kusikelwe umda.

• Unyamezelo lwempembelelo - ingaba udibaniso lwe-cage-inserter lubambe phantsi kwefuthe lokwenyani, okanye lufuna ukuphathwa ngobunono ngokungaqhelekanga okucothisa ugqirha wotyando

• Idimensional consistency — lujongano olufakelweyo lufakwe kwikheyiji yonyamezelo efanayo emva kwekheyiji, ibhetshi emva kwebhetshi, okanye iyalingana ngokwaneleyo kangangokuba ezinye iiyunithi zizive zikhululekile kunezinye.

• Ukuthelekisa isixhobo — ngaba umenzi uyabonelela ngesifakeli njengenxalenye yenkqubo eqinisekisiweyo enekheyiji, okanye sisixhobo segeneric esenzeka ukuba silingane

Ikheji edibana nayo yonke i-dimensional spec ephepheni kodwa yahlula kwisifaki sayo esiphakathi-impembelelo ayiyongxaki encinci - yimeko emileyo kunye nesithuba sediski esele silungisiwe kunye nesigulane phantsi kwe-anesthesia.

Uluhlu lweeMveliso ze-TLIF kunye ne-PLIF

Nje ukuba imathiriyeli kunye nojongano loomatshini luqinisekisiwe, umbuzo olandelayo ngowokuba ubungakanani bomenzi bokwenyani kunye noluhlu loqwalaselo luyayigubungela into efunwa ngoogqirha bakho:

• Ngokuthe nkqo vs. iinyawo ezigobileyo - iikheji ezigobileyo zixhaphakile kwi-PLIF (ukubekwa kwamazwe amabini) ngelixa iTLIF ​​ihlala isebenzisa idizayini emile njengebhanana okanye eyezintso elungele ukufakwa kwelinye icala.

• Ubude bobude - ngokuqhelekileyo i-8-14mm kwi-1mm yokunyuswa kwezicelo ze-lumbar, ezigubungela uluhlu lweediski eziphakamileyo ezifunyenweyo.

• Iinketho ze-angle ye-Lordotic - ubuncinci bomgangatho kunye nokhetho lwe-hyperlordotic (ngokuqhelekileyo ngu-0 °, 6 °, nangaphezulu kumacandelo afuna ukulungiswa kwe-sagittal ngakumbi)

• Ububanzi beenyawo kunye nobude - ukwahluka okwaneleyo ukuhambelana nobukhulu bomzimba we-vertebral ngaphandle kokunyanzelisa ukulinganisa ubungakanani obunye.

• Ukuhambelana kwe-TLIF / PLIF / MIS — nokuba iqonga elifanayo lekheji lisebenza kuzo zonke iindlela ezivulekileyo nezincinci, okanye nokuba ukubekwa kwe-MIS kufuna uyilo lwekheji eyahlukileyo ngokupheleleyo kunye nenkqubo yokufaka.

Uluhlu olumxinwa lunyanzela iqela lakho labathengisayo ukuba livumelane noogqirha botyando phakathi kwencoko - ukubaxelela ukuba olona bungakanani bukufutshane bufumanekayo 'lusondele ngokwaneleyo' endaweni yokuthelekisa eyona nto ifunwa lityala.

Ngawaphi amaxwebhu kunye noVavanyo ekufuneka abaSasasi balucele?

Ngaphambi kokuba wenze i-inventri, cela:

• I-ISO 13485 isihlomelo somda - Ukuqinisekisa ukuba iikheji zokudityaniswa kwe-interbody zibekwe ngokucacileyo ngaphakathi kwendawo eqinisekisiweyo, engacingelwanga phantsi kodidi lomqolo jikelele.

• Izatifikethi zezinto eziphathekayo — Isatifikethi se-PEEK resin lot eqinisekisa ibakala lezonyango kunye nokungabikho kwekhabhon fiber reinforcement (ngaphandle kokuba i-carbon-fiber PEEK yeyona nto iyalelwayo); iziqinisekiso ze-titanium mill ngokuchasene nomgangatho ofanelekileyo we-ASTM

• Iirekhodi zokuhlola ezinobungakanani -ukuqinisekiswa kweCMM kwindawo yeenyawo, ukuphakama, kunye nokunyamezela isitishi sokumakisha, kungekuphela nje ukuhlolwa kwenqaku lokuqala kodwa iisampulu eziqhubekayo zemveliso.

• Iingxelo zovavanyo lomatshini -uvavanyo olusisigxina kunye noluguquguqukayo loxinzelelo lwe-shear nge-ASTM F2077 nganye okanye ilingana nezixhobo zangaphakathi

• Ukulandelelwa kunye neerekhodi zebhetshi - ingaba ikheji ethile inokulandelwa umva kwindawo yayo yemveliso kunye neenyanga zebhetshi ekrwada emva kokuthunyelwa

Kubathengisi abaphonononga iinketho zekheji ezidityanisiweyo kubo bonke ababoneleli, bethelekisa olu xwebhu nelokwenene i-interbody fusion cage specifications kunye Imigca yemveliso ye-PEEK yekheji ecaleni ngecala yindlela ethembekileyo yokuvavanya kunokuthelekisa amabango okuthengisa.

Uluhlu lwempahla, i-MOQ, kunye neNkxaso ye-OEM

Iikheji ze-Interbody ziphethe i-matrix ecacileyo ebanzi - iinyawo ezininzi, ubude obuninzi, ii-angles ezininzi ze-lordotic - nto leyo ethetha ukuba uluhlu lwabasasazi kufuneka lugubungele umhlaba omninzi ukunqanda umnxeba wesibhedlele wobungakanani obungekho kwishelufu. Iinkqubo zekheji zekhathalogu ezisemgangathweni ezigcinwe kuluhlu oluphezulu lwempahla, kunye nokuthunyelwa kwempahla ngaphakathi ngokuqhelekileyo ngaphakathi kweentsuku zokusebenza ze-3, ukunciphisa amathuba okuba yingxaki yobungakanani bengxaki yokucwangcisa.

Inkxaso ye-OEM yeenkqubo zekheji ngokuqhelekileyo igubungela ukupakishwa kunye nokubhala ngokwezifiso, ukulungelelaniswa kwekhathalogu yimarike, kunye nenkxaso yamaxwebhu okubhaliswa kwendawo - ezi zikhawuleza ukuphumeza. Ijiyometri entsha yekheji okanye unyawo, ngokuchaseneyo, ifuna ukuqinisekiswa koyilo kunye novavanyo oluhlaziyiweyo ngoomatshini ngaphambi kokuba ithunyelwe, kwaye lo mgca wexesha kufuneka ubhengezwe ngokucacileyo endaweni yokubengezela.

Uluhlu lokuGqibela uVavanyo loMboneleli

Izatifikethi kunye nemibuzo yokwenziwa koqeqesho apha ilandela ingqiqo efanayo ekujongwe kuyo ngokubanzi I-China vs abavelisi be-spine base-US - yintoni eyahlula umthengisi we-cage othembekileyo ukusuka kumngcipheko wolawulo lwenkqubo ebhaliweyo, kungekhona apho i-factory eyenzekayo ihleli kwimephu.