Nigute wasuzuma Pedicle Screw Sisitemu Yakozwe Mubushinwa

Abadandaza benshi bagereranya pedicle screw abatanga batangirana nigiciro cyibice kuri monoaxial na polyaxial screw, hanyuma bakore basubira inyuma bava aho. Ngiyo ingingo yo kwinjira nabi. Sisitemu ya pedicle screw ntabwo yatewe kimwe - nigikorwa cyuzuye cyo kubaga kigomba gufatanyirizwa hamwe muburyo bwa screw, inkoni, umuhuza, ibikoresho byo kugabanya, kugenzura umuriro, trayeri, hamwe ninyandiko zituma ibitaro byakira ibicuruzwa na gato. Igiciro gifite akamaro gusa umaze kumenya ko sisitemu isigaye ikora.

Ibi byanditswe byumwihariko kubagurisha basuzuma ubushinwa bushingiye kuri pedicle screw sisitemu yo mubushinwa - icyo ugomba kugenzura mbere yuko ukora ibarura, nibikunda kugenda nabi mugihe abadandaza basimbutse kugereranya ibiciro.

Impamvu sisitemu ya pedicle ya sisitemu itari iyindi bicuruzwa byumugongo

Akazu ahanini karimo-geometrie, ibikoresho, byakozwe. Sisitemu ya pedicle sisitemu iratandukanye kuko ikusanyirijwe muri OR uhereye mubice byinshi byose bigomba gukorana neza munsi yumutwaro: umugozi wicaye mumagufa, inkoni yanyuze mumutwe wimigozi, umugozi washyizweho ufunze kumurongo wihariye, umuhuza wikiraro cyangwa urwego rwambukiranya imipaka, hamwe nigikoresho cyashyizweho kigabanya kugabanya, gutesha agaciro, no gukomera kwanyuma.

Niba hari kimwe muri ibyo bice cyabuze kurutonde rwabagabanije - diameter iburyo ya diameter ya pedicle ifunganye, guhuza ibice bitatu byubatswe, umunara wo kugabanya ikibazo cya spondylolisthesis - umuganga abaga amenya uburyo bwo hagati, atari mugihe cyo guhamagara kugurisha. Nibintu bibi cyane kuruta SKU yabuze ku gipangu. Nibibazo byahagaritswe numurwayi asanzwe anesthesia.

Reba Igifuniko Cyuzuye Cyuzuye Mbere yo Kugereranya Igiciro

Mbere yo kugena ikintu icyo aricyo cyose, shushanya ibyo uwabikoze atanga mubyukuri byuzuye ikibazo cyo gukosora inyuma gisaba:

• Ubwoko bw'imigozi - monoaxial (kubwubaka-buringaniye bwubaka, akenshi kurwego rwo hejuru rwo gukosora ubumuga), polyaxial (kubibazo byinshi bisanzwe, kwemerera kwihanganira inguni mugihe cyo kwicara inkoni), imiyoboro yo kugabanya (kubwo spondylolisthesis cyangwa kugabanya kuvunika), hamwe na screw (kubishyira kuri MIS kuri buri cyerekezo)

• Inkoni - amahitamo ya diameter (5.5mm na 6.0mm ikubiyemo ibintu byinshi bikenerwa gukosorwa), ibikoresho (titanium alloy na cobalt-chromium kugirango irusheho kunanirwa mumyubakire miremire), n'uburebure burebure

• Guhuza no guhuza - kubikorwa byinshi-byubatswe, imanza zisubirwamo, cyangwa ikiraro hagati yingingo zingana zingana.

• Ibikoresho byabigenewe - abashakisha pedicle, kanda, screwdrivers, abafite inkoni, ibikoresho byo kugabanya, hamwe nudukingirizo twa torque, bihujwe na verisiyo ifunguye na MIS ya sisitemu.

Niba uwabikoze ashobora kwerekana byuzuye Urutirigongo rwimikorere ya sisitemu izengurutswe inyuma yinyuma MIS yo gukosora uruti rwumugongo, icyo nikiganiro gitandukanye cyane numuntu ushobora kuvuga gusa imigozi ninkoni hamwe nibikoresho byagurishijwe bitandukanye, mugihe gitandukanye cyo kuyobora, uhereye kumurongo utandukanye.

Kuringaniza na Rod Guhuza Ibyingenzi Kurenza Ingano ya Cataloge

Urupapuro rurerure ntirukubwira niba sisitemu ikora neza muri OR. Icyangombwa mubyukuri biragoye kubona kumpapuro:

• Kuramo umutwe uhamye - umutwe wa polyaxial ufata inguni yawo neza iyo inkoni imaze kwicara, cyangwa irahinduka gato mugihe cyo gufunga kwa nyuma, guta umurongo wubaka?

• Inkoni-to-screw irakwiriye - ese diameter yinkoni ihuye rwose numuyoboro wa tulip ya screw, cyangwa harikinamico ihagije inkoni ivuza mbere yuko umugozi washyizweho ukomeza?

• Shiraho imyitwarire yo gufunga imigozi - kwikuramo ibice (bisanzwe kuri sisitemu 5.5mm) bikenera itara rihoraho. Niba iryo tara ritandukana mugice kimwe, kubaga baba badakomeye kubera kwitonda cyangwa umugozi ntusibe isuku, byombi bigabanya umuvuduko.

• Gufata ibikoresho - ese icyuma gishobora kunyerera ku mutwe wa screw munsi ya torque, cyane cyane ku murwayi wimbitse cyangwa umubyibuho ukabije aho umuganga ubaga akorana no kutabona neza no kongera ibyifuzo?

• Ibikoresho bya tray - ni tray yateguwe muburyo tekinoroji ya scrub itamenyereye sisitemu ishobora gukurikira, cyangwa bisaba rep kuyinyuramo muri buri kibazo?

Nibisobanuro birambuye bitandukanya sisitemu yo kubaga yihanganira nimwe bakunda. Ntanumwe murimwe ugaragara kumafoto yibicuruzwa.

Ni izihe nyandiko zujuje ubuziranenge ukwiye gusaba?

Iki nigice abagabuzi benshi badashora imari, kandi nigice kikurinda niba hari ibitagenda neza mumyaka itatu mumasezerano yibitaro. Mbere yo kwiyemeza gutanga isoko, saba:

• Umugereka wa ISO 13485 - kwemeza ko ikubiyemo sisitemu ya pedicle screw sisitemu, ntabwo ari icyemezo rusange cya orthopedic implant gihinduka kibaho harimo urutirigongo nkicyiciro

• CE inyandiko aho ikoreshwa kumasoko yawe

• Impamyabushobozi y'ibikoresho - urusyo rwa titanium alloy stock, yemeza imiterere yimiti hamwe nubukanishi butandukanye na ASTM bijyanye

• Raporo yikizamini cya mashini - igeragezwa rihamye kandi rifite imbaraga kuri ASTM F1717 cyangwa bihwanye na sisitemu yo gukosora urutirigongo, byerekana imyubakire ifashe munsi yumutwaro wimiterere.

• Ikizamini cyo gupima umunaniro - byumwihariko kuri inkoni na screw, kubera ko aha ariho sisitemu yo gukosora ikunda kunanirwa niba ibikoresho cyangwa ubwiza bwibikorwa bidahuye

• Inyandiko zikurikirana - zishobora gukurikirana umugozi wihariye ugasubira mubikorwa byacyo hamwe nibikoresho fatizo, amezi cyangwa imyaka nyuma yo koherezwa?

• Igenzura ryibikoresho - kugenzura ibipimo kubikoresho byo kugabanya hamwe na torque wrenches, ntabwo biri kubitera ubwabo

Kuri XC Medico, isuzuma rya pedicle screw sisitemu irashobora gushyigikirwa hamwe nibisobanuro byerekana ibintu, ibyiciro byo murwego rwo kugenzura imashini, hamwe nibicuruzwa byuzuye byerekana ibicuruzwa kugirango bisuzumwe mbere yuko hashyirwaho itegeko.

Gufungura kubaga na MIS: Ushobora gutanga byombi?

Abenshi mu bagabura umugongo barangiza bakeneye gufungura no gufungura MIS pedicle screw, kubera ko ibitaro bivanze bidakunze kugwa kuruhande rumwe. Urubanza rusubirwamo cyangwa urwego rwinshi rwo gukosora ubugororangingo rusanzwe rufunguye. Urwego rwa 1-2 rwangirika murwego rwo hejuru rwo kubaga rwinshi rugenda rukorwa muburyo butandukanye.

Niba uwaguhaye ibicuruzwa akora kimwe gusa - vuga, sisitemu ifunguye ariko idafite ibikoresho bya percutaneous - warangiza ugashakisha MIS ukwayo nuwabikoze wa kabiri, ucunga ibintu bibiri bidafitanye isano, uhugura itsinda ryanyu ryo kugurisha kubintu bibiri bitandukanye, kandi wizeye ko screw geometrie idatera urujijo kurwego rwa OR.

Uruganda rutanga byombi an fungura uruti rwumugongo sisitemu kandi irahuye Sisitemu yo gukosora umugongo - yubatswe hafi ya screw geometrie isanganywe hamwe nibisobanuro byinkoni - ikuraho ibyo gucamo ibice. Igenamigambi rya kataloge rihinduka ikiganiro kimwe aho kuba umubano utandukanye utanga amasoko abiri atandukanye.

Ibarura, MOQ, no Gutanga Nibice byubuziranenge bwibicuruzwa

Umugabuzi ntabwo agura imigozi ninkoni gusa - bagura ubushobozi bwo kugira ingano iboneye mumaboko mugihe ibitaro byahamagaye nurubanza ruteganijwe ejo. Sisitemu ya pedicle ifite sisitemu yagutse (diametero nyinshi, uburebure bwinshi, monoaxial na polyaxial, bisanzwe kandi byanduye), kandi ibitaro bikunze gukenera kuzuza gahunda isanzwe hamwe nubunini budasanzwe hagati. Niba ibicuruzwa byawe bitanga ibicuruzwa bito, icyo cyuho kiba ikibazo cyawe mugihe kibi gishoboka.

Kubakwirakwiza binjira mumasoko mashya yumugongo, MOQ ntoya kubintu bitandukanye: intego yambere ntabwo yuzuza ububiko. Intego yambere nukwemeza kwemerwa kubaga, kwemeza ibyangombwa bihuye nibisabwa kugirango wiyandikishe, kandi urebe ibyifuzo byibitaro mbere yo gutanga igishoro cyuzuye. Kubatangije icyiciro, XC Medico irashobora gushyigikira isuzuma rya sisitemu ya pedicle screw na OEM / ODM imishinga yumugongo kuva 1 yashizeho MOQ, ifasha abakiriya kwemeza kubaga abaganga, ibyangombwa bikwiye, nibisabwa mubitaro mbere yo gupima ibarura. Utanga isoko isaba ibicuruzwa bito byibuze hejuru ya diameter ya screw yose hamwe na matrix ndende iguhatira gukeka kubisabwa mbere yuko ugira ibimenyetso bifatika.

Urutonde rusanzwe rwibikoresho byumugongo bikomeza kubikwa hejuru, hamwe no koherezwa mububiko muminsi 3 yakazi, bihindura kubara cyane - ntutegereje ibyumweru kugirango wuzuze icyuho mubisobanuro byawe igihe ingano yimanza itangiye kuza.

Inkunga ya OEM na Private Label: Ni iki mu byukuri gikwiye kuba Customizable?

Inkunga ya OEM irekuwe neza, birakwiye rero gutandukanya ibyoroshye guhinduka nibisabwa kwemeza injeniyeri nyayo:

• Kwamamaza ibicuruzwa - kuranga ikirango, gushushanya laser, gushushanya amabara ya kode ya diameter - ibi birihuta kandi bihendutse, mubisanzwe gupakira no kwerekana ibimenyetso aho guhinduka mubishushanyo.

• Gupakira ibicuruzwa - imiterere ya tray, imvugo yikirango, imiterere ya sterile barrière - nayo yihuse kubishyira mubikorwa

• Inkunga yinyandiko - gutegura dosiye yo kwiyandikisha, ibisobanuro bya IFU, guhinduranya dosiye ya tekiniki kurwego rwihariye rushinzwe kugenzura isoko - ibi bisaba guhuza kwukuri ariko ntibisaba kongera gushushanya uwatewe

• Ibicuruzwa byifashishwa ku isoko - guhitamo ingano ya diameter, ubwoko bwa screw, hamwe nuburebure bwinkoni bijya muri kataloge yawe yihariye mugihugu runaka ukunda kubaga abaganga - iki nicyemezo gikomoka, ntabwo ari uguhindura igishushanyo.

Ibitandukanye - nibigomba gushyirwaho ibendera neza, bidashyizwe hejuru - ni uguhindura igishushanyo mbonera: umutwe mushya wa geometrie, ishusho itandukanye, umurongo winkoni ya diameter hanze yumushinga wemewe. Ibyo bisaba kugenzura ibishushanyo mbonera, kugerageza imashini, no kuvugurura inyandiko. Ni serivisi yemewe abayikora benshi batanga, ariko ifite igihe nigiciro nyacyo, kandi uwaguhaye isoko akubwiye ko ihinduka byihuse kubishushanyo mbonera bishya ntabwo ari byiza nawe.

Ibendera ritukura mugihe uhisemo pedicle umugozi utanga isoko

Uburyo buke bukwiye gufatwa nkibyemezo aho gufata amakimbirane mato:

• Kohereza igiciro cyibiciro mbere yuko ubona urupapuro rwuzuye rwerekana ibipimo bya diameter, uburebure buringaniye, nibintu byahisemo

• Berekana amafoto yibicuruzwa bya screw gusa, nta kugaragara mubikoresho byashizweho bijyana nabo

• Ntibashobora kuvuga neza igipimo cya titanium alloy igipimo cyatewe, cyangwa gusubiza hamwe na 'urwego rwubuvuzi titanium '.

• Ntibashobora gusobanura uburyo uburyo bwo gufunga screw bwashyizweho cyangwa icyo gucamo ibice byagenewe

• Ntibashobora gutanga ibyiciro byerekana ibyasabwe, cyangwa gufata ikibazo nkibidasanzwe

• Imihigo yo gutanga ivugwa gusa nka 'gutanga vuba ' nta bisobanuro byibyakozwe mububiko bitandukanye no gutumiza

• Batanga gusa imigozi ya pedicle mu bwigunge, nta sisitemu nini yagutse - bivuze ko nta murongo w’umurongo w’umuntu, nta mahitamo y’inkondo y'umura, nta kintu na kimwe cyakwemerera kubaka urutonde rwuzuye rw'umugongo hamwe n'umubano umwe utanga isoko.

Nta na kimwe muri ibyo ku giti cye cyanga uwagitanze. Hamwe na hamwe, mubisanzwe bivuze ko ukorana nisosiyete yubucuruzi igurisha ibicuruzwa byabandi, ntabwo ari uruganda rugenzura inzira irangira.

Isuzuma ryanyuma

Niba upima uruganda rukorera mubushinwa kurwanya ikirango cyiburengerazuba bwa sisitemu ya pedicle screw, icyemezo kimwe na logique nziza biri murwego rwo kugereranya kwacu Ubushinwa n’inganda zikora umugongo muri Amerika zirakurikizwa hano - ikintu gifata ibyemezo cyanditse mubikorwa byo gukora, ntabwo ari geografiya.

Ibibazo: Uruganda rukora amashanyarazi mu Bushinwa

Nigute abagabuzi bagomba gusuzuma uruganda rukora pedicle screw mubushinwa?

Abatanga ibicuruzwa bagomba gusuzuma sisitemu yuzuye, screw hamwe ninkoni ihuza, ibikoresho byashizweho, ibipimo bya ISO 13485, ibikoresho bikurikirana, inyandiko zipima imashini, hamwe no kwizerwa mbere yo kugereranya igiciro cyibice.

Ni izihe nyandiko utanga pedicle screw utanga?

Umutanga wujuje ibyangombwa agomba gutanga amakuru ya ISO 13485, ibyangombwa bya CE aho bibaye ngombwa, ibyemezo byibikoresho, inyandiko zipima imashini n'umunaniro, ibyiciro bikurikirana, nibicuruzwa bisubirwamo.

Abagabuzi bagomba guhitamo sisitemu yo gufungura cyangwa MIS pedicle screw?

Abenshi mubakwirakwiza bakeneye gufungura uruti rwumugongo hamwe na MIS yo gukosora umugongo kuko kuvanga ibitaro bishobora kubamo gusubiramo ubugororangingo, gukosora urwego rwinshi, hamwe nindwara zangirika.

XC Medico irashobora gushyigikira OEM cyangwa sisitemu yihariye ya label pedicle screw?

XC Medico irashobora gushyigikira OEM hamwe na label-yigenga ya spine yatewe hamwe nibicuruzwa, gupakira, kuranga, inkunga yinyandiko, hamwe na gahunda yo gutangiza icyiciro kuva 1 yashizeho MOQ.