Izikrufu ze-Pedicle, iintonga kunye nezixhobo zokutshixa zenza i-posterior fixation construction ekwazi ukuzinzisa amacandelo omqolo okhethiweyo ngelixa i-fusion ikhula. Ukhetho lwenkqubo kufuneka lusekelwe kwi-anatomy ephathwayo, ukusetyenziswa okujoliswe kuyo, isicwangciso sokwakha, umgangatho wamathambo, izixhobo ezihambelanayo kunye namaxwebhu emveliso ethe ngqo kwimarike.
Ziziphi izikrufu zePedicle?
Izikrufu ze-Pedicle zizinto zokulungisa ezifakelwayo ezifakwe kwi-vertebral pedicle kumzimba we-vertebral. Emva kokuba zixhunywe kwiintonga ze-longitudinal, zibonelela ngamanqaku e-anchor kwi-posterior spinal construct. Ngokuxhomekeke kwinkqubo ethile kunye nokubhaliweyo kwayo ekujoliswe kuyo, i-pedicle screw constructs ingasetyenziselwa njengenxalenye yeenkqubo ezijongene nokungazinzi komatshini okanye ukukhubazeka okudinga ukudibanisa kunye ne-instrumentation.
Igama elithi 'i-pedicle screw' lichaza udidi lwecandelo, hayi ukufakelwa kwezinto zonke. Iinkqubo ziyahluka kuyilo lwe-screw, ububanzi kunye nobude boluhlu, i-diameter yentonga, indlela yokutshixa, izixhobo, izixhobo, ukufakwa komsebenzi kunye nezibonakaliso ezivunyiweyo. Ezi nkcukacha mazingqinwe kumaxwebhu enkqubo kanye evandlakanywayo.
Yintoni eyenza iPedicle Screw Construction?
Ulwakhiwo olupheleleyo ludla ngokubandakanya ngaphezulu kwesikrufu ngokwaso. Elona candelo lichanekileyo liyahluka ngokomenzi kunye nenkqubo, kodwa uvandlakanyo ludla ngokubandakanya ezi ndidi zilandelayo.
| Icandelo lecandelo | Indima ngokubanzi kulwakhiwo | Yintoni ekufuneka abathengi bayiqinisekise |
|---|---|---|
| Isikrufu sePedicle | Inika i-anchor ngaphakathi kwe-vertebra | Uyilo, imilinganiselo, ummandla womqolo ocetywayo, ukucaciswa kwemathiriyeli kunye nokuleyibhile |
| Intonga | Idibanisa iiankile kuwo onke amanqanaba anyangweyo | I-diameter, ubude obukhoyo okanye iifom, izinto kunye nokuhambelana nentloko ye-screw |
| Icandelo lokutshixa | Ikhusela intonga ngaphakathi kwentloko yesikrufu | Ulandelelwano lokutshixa, umqhubi ofunekayo, imiyalelo ye-torque kunye nesimo sokusetyenziswa okukodwa |
| Izihlanganisi | Inokwandisa okanye idibanise iinxalenye zesakhiwo xa zibandakanyiwe kwisistim | Ulungelelwaniso oluvunyiweyo kunye nokuhambelana kwenkqubo ethile |
| Izixhobo zokufakela | Ukulungiswa kwenkxaso, ukufakwa kwezikrufu, ukubeka intonga kunye nokutshixa okokugqibela | Uluhlu lwezixhobo, uyilo lwetreyi, ukugcinwa, ukutshintshwa kunye nemiyalelo yokuhlaziya |
Abasasazi akufuneki baqikelele ukuhambelana okunqamlezayo ukusuka kwimilinganiselo efanayo okanye inkangeleko. Izixhobo kunye nezixhobo ezivela kwiinkqubo ezahlukeneyo akufuneki zixutywe ngaphandle kokuba usetyenziso olunjalo luxhaswa ngokucacileyo ngamaxwebhu afanelekileyo omenzi kunye neemfuno ezifanelekileyo.
Indlela iPedicle Screw Fixation ixhasa ngayo i-Spinal Fusion
I-Spinal fusion ijolise ekudaleni ibhuloho yethambo eqhubekayo phakathi kwe-vertebrae ekhethiweyo. Ukwakhiwa kwe-pedicle screw-and-rod kunokunciphisa ukunyakaza kumanqanaba ezixhobo kunye nokugcina ubudlelwane obucwangcisiweyo phakathi kwe-vertebrae ngelixa i-fusion ikhula. Ulwakhiwo ke ngoko luxhasa ubume be-fusion; ayithathi indawo yokulungiswa kwamathambo, isicwangciso sokuxhunyelelwa okanye ukuphiliswa kwebhayoloji.
Isiphumo seklinikhi asinakuqikelelwa kwisikrufu sodwa. Iziphumo zinokuphenjelelwa ngokuxilongwa, inqanaba lomgogodla, indlela yokuhlinzwa, isicwangciso sokwakha, umgangatho wamathambo, ukufakwa kokufakelwa, ukhetho lwe-graft, isimo sokutshaya, i-comorbidities, ukuthotyelwa kwemiyalelo emva kokuhlinzwa kunye nezinye izinto. Ngenxa yesi sizathu, iphepha lemveliso okanye inqaku lezemfundo akufanele lithembise izinga elithile lokudibanisa, ukunciphisa intlungu okanye ixesha lokubuyisela.
Ukusetyenziswa kweThoracolumbar kunye neCervical kufuna uVavanyo olwahlukileyo
I-Pedicle morphology, izakhiwo ezijikelezileyo, izicwangciso zokulungiswa kunye neenkqubo ezikhoyo zihluke kuwo wonke umqolo. Ingxelo ebanzi yokuba isikrufu esinye sisebenzela 'intamo kunye nomqolo osezantsi' ke ngoko ayanelanga kwizigqibo zeklinikhi okanye zokuthenga.
Ukwakhiwa kwe-Thoracolumbar kunokusebenzisa iinkqubo ezivulekileyo okanye ze-percutaneous pedicle screw. Abathengi kufuneka baqinisekise uluhlu olulebhile lwe-anatomical, isikrufu kunye noluhlu lweentonga, ukhetho lokunciphisa, izixhobo ezihambelanayo kunye nayo nayiphi na imida yenkqubo ethile.
Ukulungiswa kwe-pedicle yomlomo wesibeleko kubandakanya ingqwalasela eyahlukileyo ye-anatomical kwaye akufanele isetyenziswe ngokubanzi kwidatha ye-lumbar. Qinisekisa ukuba inkqubo evavanyiweyo ijoliswe ngokukodwa kwingingqi yomlomo wesibeleko okanye i-occipitocervical-thoracic kwaye ihlolisise ubuchule bayo obuzinikeleyo kunye nezixhobo.
I-XC Medico idwelisa iimveliso ezahlukeneyo zomlomo wesibeleko, kubandakanywa a inkqubo yokulungiswa komlomo wesibeleko yangasemva . Iimpawu zayo, ukusetyenziswa okujoliswe kuyo kunye nokuhambelana kufuneka kuhlolwe ngokuzimeleyo kwi-thoracolumbar pedicle screw systems.
Uyilo oluqhelekileyo lwe-Pedicle Screw
La magama alandelayo achaza iindidi zoyilo eziqhelekileyo kulo lonke ushishino. Abayi kuseka iimpawu zemveliso ethile ye-XC Medico ngaphandle kokuba iqinisekisiwe kwiphepha lemveliso elihambelanayo kunye namaxwebhu obugcisa.
| Udidi loyilo | Uphawu ngokubanzi | Indawo yoVavanyo |
|---|---|---|
| I-Monoaxial | Intloko ye-screw inobudlelwane obusisigxina kwi-shaft | Ukuvavanya usetyenziso olucetywayo lolwakhiwo kunye neemfuno zolungelelwaniso lwentonga |
| Polyaxial | Intloko iyakwazi ukuthetha phambi kokutshixa kokugqibela | Hlaziya uluhlu lwe-angulation, indlela yokutshixa kunye nezixhobo ezihambelanayo |
| Ukunciphisa isikrufu | Intloko eyandisiweyo inokuncedisa ukunciphisa intonga ngaphambi kokuhlanganisana kokugqibela | Qinisekisa ukuhamba komsebenzi wokunciphisa, indlela yokususa ithebhu kunye nezixhobo ezizinikeleyo |
| Isikrufu esiqinileyo | Yenzelwe ukufakwa ngokuqhutywa kwenkqubo yolungiselelo oluchaziweyo | Qinisekisa iimpompo, iiprobe, abaqhubi kunye nolandelelwano lofakelo |
| Isikrufu esikhonkxiweyo | Iqulethe umjelo osembindini onokuxhasa ufakelo olusekwe kwisikhokelo | Qinisekisa i-guidewire, i-dilator kunye ne-imaging workflow, kunye nezilumkiso zenkqubo |
I-Screw diameter, ubude kunye ne-trajectory 'enkulu ihlala ingcono' izigqibo. Bakhethwa ngokusebenzisa i-anatomy, umgangatho wamathambo, ukucinga, ukwakha iimfuno, isigwebo sogqirha kunye nemida yenkqubo ekhethiweyo.
Vula xa kuthelekiswa neeNkqubo zeSikruru zePedicle
Iisistim ezivulekileyo kunye ne-percutaneous zinokwenza zombini ukwakhiwa kokulungiswa ngasemva, kodwa ukufikelela kwabo, ukuhanjiswa kokufakelwa kunye neemfuno zesixhobo ziyahluka. 'I-invasive kancinane' ichaza indlela yokusebenza kunye nokuhamba komsebenzi; akufanele isetyenziswe njengesithembiso sehlabathi jikelele seziphumo ezingcono zeklinikhi kwisigulane ngasinye okanye isalathisi.
| Indawo yovavanyo | Inkqubo evulekileyo | yePercutaneous/MIS |
|---|---|---|
| Ukufikelela | Ukuvezwa ngokuthe ngqo kwezinto ezingasemva | Iipaseji zokufikelela ezincinci kusetyenziswa izixhobo zonikezelo ezizinikeleyo |
| Ufakelo lwezikrufu | Inkqubo ecacileyo yokuvula kunye nezixhobo zofakelo | Rhoqo usebenzisa i-guidewire- kunye namanyathelo axhomekeke kwiimaging xa kuchaziwe |
| Ukuhanjiswa kweentonga | Intonga ibekwe kulwakhiwo oluveziweyo | Ukuhanjiswa komsebenzi onikezelweyo we-percutaneous rod |
| Iimfuno zesixhobo | Vula itreyi kunye nezixhobo zokuyila | Iidilayitha, imikhono, iinqaba okanye izandisi kunye nezixhobo ze-MIS rod njengoko zisebenzayo |
| Umbuzo ongundoqo wokuthengwa kwempahla | Ngaba ubumbeko olupheleleyo lwesixhobo esivulekileyo lunikiwe? | Ingaba lonke ufikelelo, ucingo lwesikhokelo, unciphiso kunye nokuhanjiswa kweentonga kubandakanyiwe? |
Ngomzekelo wenkqubo ethile, jonga kwakhona iphepha lenkqubo ye-pedicle screw encinci kwaye icele ukucaciswa kwayo kwangoku, uluhlu lwezixhobo kunye namaxwebhu ngaphambi kokwenza ukuhambelana okanye isigqibo sokufikelela kwimarike.
Izinto ezisetyenziselwa ukukhetha i-Pedicle Screw System
Ukhetho lwezonyango lolweqela elinyangayo. Amaqela okuthenga axhasa eso sigqibo ngokuqinisekisa ukuba ulungelelwaniso olucetywayo lugqityiwe, lubhalwe kwaye lufanelekile kwimarike yendawo ekusingwa kuyo.
Imiba yeklinikhi kunye nezobugcisa
- Ummandla womqolo kunye namanqanaba afakwe kulwakhiwo
- Uxilongo, ukungazinzi okanye ukukhubazeka okuqwalaselwa yinkqubo ecwangcisiweyo
- I-Pedicle morphology, ikhorido yamathambo ekhoyo kunye nendlela ecwangcisiweyo
- Umgangatho wamathambo kunye nayiphi na imida yenkqubo ethile
- Indlela yotyando evulekileyo, enemikrozo okanye enye ecetyiweyo
- Ukuziphatha okufunekayo kwe-screw-head, isicwangciso sokunciphisa kunye nokucwangciswa kwentonga
- Ukuqeqeshwa kogqirha kunye nokuqhelana nenkqubo echanekileyo
- Ukuleyibhelishwa kwemveliso, imiqondiso, izichaso, izilumkiso kunye nezilumkiso
Izinto zokuthengwa nokuhanjiswa kwazo
- Gqibezela isikrufu kunye noluhlu lwentonga olufunekayo kwiimeko ezicwangcisiweyo
- Ukuhambelana okuqinisekisiweyo kokufakelwa, iindawo zokutshixa kunye nezixhobo
- Ukugqibelela kwetreyi yesixhobo, ukuhlolwa kunye nenkqubo yokutshintshwa
- Ubume bonikezelo obunyumba okanye obungenantsholongwane kunye nolwazi olusebenzayo lokuphatha
- Ukuleyibhelishwa, ukulandeleka, ulawulo lweqashiso kunye nolungiselelo lokupakisha
- Ubhaliso olungqale kwimarike kunye nokufumaneka koxwebhu lobugcisa
- Uxanduva lokutshintsha-isaziso kunye nolawulo loguqulelo
- Uqikelelo, ixesha lokuzaliswa kwakhona kunye nobungakanani obubalulekileyo be-inventory
Imingcipheko enokubakho kunye nokulinganiselwa kobungqina
Iingxaki ezinokuthi zidibene ne-instrumented spinal fusion zingabandakanya ukungahambi kakuhle, i-neurological or vascular injury, ukukhulula, ukukhupha, ukufakelwa kwe-deformation okanye ukuphuka, ukusuleleka, ukulahleka kokulungiswa, ukungabikho kunye nesidingo sokuhlaziywa. Olu ayiloluhlu olupheleleyo. Ilebhile yenkqubo esebenzayo kufuneka isetyenziselwe izalathisi zayo ezipheleleyo, izichaso, izilumkiso, izilumkiso kunye nolwazi lwesiganeko esibi.
Itekhnoloji yokubeka yenye indawo apho ubungqina kufuneka buchazwe ngononophelo. Uphononongo olucwangcisiweyo lwe-2024 kunye nohlalutyo lwe-meta lwe-thoracolumbar fixation luchaze ulwahlulo oluncinci kwiklinikhi eyamkelekileyo yokubeka isikhonkwane phakathi kwamaqela ahambahambayo kunye namaqela endabuko, ngelixa kungekho mahluko abalulekileyo kwiintlungu okanye amanqaku okukhubazeka. Uphononongo olucwangcisiweyo olwahlukileyo lwezikrufu ze-pedicle zomlomo wesibeleko aluzange lufumane inzuzo ebalulekileyo ehambelana nokuchaneka okuchanekileyo. Ezi ziphumo akufanele zidityaniswe kwibango eliqhelekileyo lokuba ukuhamba rhoqo kuphucula zonke iziphumo zotyando okanye isigulane.
Uluhlu lweNkqubo ye-Pedicle Screw yaBasasazi
Ngaphambi kokuba ucele ikowuteshini yokugqibela okanye ukwakha isicwangciso sobhaliso sendawo, cela ubungqina obubotshelelwe kumzekelo kunye nemarike. Olu luhlu lulandelayo sisiqalo kwaye kufuneka luhlengahlengiswe ngokweemfuno zengingqi.
| Ukuphonononga isigaba | Imibuzo yokubuza | ubungqina obunokucelwa |
|---|---|---|
| Umda wenkqubo | Zeziphi izihlomelo kunye nezixhobo ezenza inkqubo epheleleyo? | Ikhathalogu yangoku, uluhlu lwamacandelo kunye noluhlu lwezixhobo |
| Ukusetyenziswa okucetywayo | Ngowuphi ummandla we-anatomical, iimeko kunye nabasebenzisi abagqunyiweyo? | Ukubhaliswa ngokuthe ngqo kwimarike, i-IFU kunye nobungqina bokubhalisa |
| Imilinganiselo | Ngaba isikrufu esifunekayo, intonga kunye noluhlu lwesihlanganisi luyafumaneka? | Amaphepha engcaciso aqinisekisiweyo kunye neekhowudi zokuodola |
| Ukuhambelana | Ngawaphi amalungu anokusetyenziswa kunye? | Imatriksi ehambelana nomenzi okanye amaxwebhu alawulwayo |
| Izinto eziphathekayo | Yeyiphi imathiriyeli esebenzayo kwilungu ngalinye lofakelo? | Ukucaciswa kwezinto eziphathekayo kunye nobungqina obusebenzayo bokuhambelana |
| Izixhobo zomculo | Ngaba isigqubuthelo setreyi silungiselela, sifaka, sicuthiwe kwaye sitshixelwe okokugqibela? | Uyilo lwetreyi, amagama esixhobo kunye nemiyalelo yogcino |
| Ulungiselelo lonikezelo | Ngaba imveliso ayinyumba okanye ayinyumba, kwaye ipakishwa njani? | Ukupakishwa kobumbeko, ukuleyibheli kunye nolwazi lokuphatha |
| Ukulandeleka | Ingaba imodeli, ubungakanani kunye neqashiso ichongwa njani ngokusasazwa? | Iileyibhile yesampuli, irekhodi yokulandeleka kunye nokuhamba komsebenzi wesikhalazo |
| Guqula ulawulo | Ingaba imveliso, inkqubo, umthengisi okanye utshintsho lweelebhile lunxibelelwana njani? | Isivumelwano somgangatho kunye nemigaqo yesaziso sokutshintsha |
Phonononga iXC Medico Pedicle Screw System Pages
Ezi khonkco zilandelayo ziqala ngamanqaku okuvavanya imveliso, kungekhona izitatimenti zokuba iinkqubo zitshintshisana okanye zifanelekile kwisigulane esithile. Qinisekisa uxwebhu lwangoku loqwalaselo oluludingayo.
Khangela uluhlu olubanzi lwemveliso ye-XC Medico phambi kokunciphisa uqwalaselo olufunekayo.
Hlaziya iphepha lemveliso elizinikeleyo kwaye ucele icandelo langoku kunye namaxwebhu esixhobo.
Vavanya le nkqubo ngokuzimeleyo kumda, ulungelelwaniso olukhoyo kunye namaxwebhu.
Jonga ukugqibelela kwetreyi kwaye uqinisekise ukuba isixhobo ngasinye sihambelana nenkqubo yofakelo ekhethiweyo.
Ngombono obanzi wokufakelwa kwezinto ezinxulumeneyo kunye nezixhobo, tyelela i-XC Medico's izisombululo zokulungisa umqolo.
Imibuzo ebuzwa qho
Yintoni indima ye-pedicle screws kwi-spinal fusion?
Izikrufu zePedicle zisebenza njengeiankile zolwakhiwo olusekelwe kwintonga. Ulwakhiwo lunciphisa intshukumo kwaye lugcine ulungelelwaniso olucwangcisiweyo ngelixa ukudibanisa kwebhayoloji kukhula. Izikrufu ngokwazo azenzi fusion.
Ngawaphi amacandelo enza i-pedicle screw construct?
Ulwakhiwo ludla ngokubandakanya izikrufu ze-pedicle, iintonga kunye namacandelo okutshixa, kunye nezihlanganisi okanye amacandelo okunciphisa apho inkqubo ethile ivumela. Izixhobo ezinikezelweyo ziyafuneka ukulungiselela, ukufakwa, ukubekwa kweentonga kunye nokutshixa okokugqibela.
Yintoni umahluko phakathi kwe-MIS evulekileyo kunye ne-MIS pedicle screw systems?
Ziyahluke kakhulu ekufikeleleni, ukuhanjiswa kokufakelwa kunye nokuhamba komsebenzi wezixhobo. Iinkqubo zePercutaneous zifuna ukufikelela okuzinikeleyo kunye nezixhobo zokuhanjiswa kweentonga. Akukho nanye indlela ekufuneka ichazwe njengeyongamileyo kuyo yonke imiqondiso okanye isigulana.
Ngaba iikhomponenti ezivela kwiinkqubo ze-screw ze-pedicle ziyaxutywa?
Musa ukucinga ukuhambelana kwimilinganiselo efanayo okanye inkangeleko. Sebenzisa kuphela ulungelelwaniso oluxhaswa ngamaxwebhu afanelekileyo omenzi kunye neemfuno ezifanelekileyo zolawulo.
Ngawaphi amaxwebhu afanele ukucelwa ngumhambisi?
Cela ikhathalogu yangoku kunye neekhowudi zoku-odola, isistim kunye noluhlu lwezixhobo, iinkcukacha, iileyibhile kunye ne-IFU, ulwazi lwezinto eziphathekayo, ukupakishwa kokupakisha, ulwazi lokulandelelwa kunye namaxwebhu olawulo oluthe ngqo kwiimarike ezisebenzayo kwiimveliso ezichanekileyo.
IiReferensi kunye noMda woBungqina
- US FDA. Isikhokelo soShishino kunye nabasebenzi be-FDA: Inkqubo yoMnqonqo 510 (k) s.
- UPapalia GF, et al. Ukulungiswa kwe-screw ye-thoracolumbar pedicle screw ngokubhekiselele kwiindlela eziqhelekileyo: ukuphononongwa ngokuchanekileyo kunye nohlalutyo lwe-meta. Umqolo. 2024.
- Ukubekwa ngokuchanekileyo kunye nokuhlaziywa kwee-screws ze-pedicle zomlomo wesibeleko ezibekwe kunye okanye ngaphandle kokuhamba: ukuphononongwa ngokuchanekileyo kunye nohlalutyo lwe-meta. 2023.
- Perdomo-Pantoja A, et al. Ukuchaneka kweendlela zangoku zokubeka i-pedicle screws kumqolo: ukuphononongwa ngokuchanekileyo kunye nohlalutyo lwe-meta. Umqolo. 2019.
I-Medical and regulatory disclaimer: Eli nqaku libonelela ngolwazi jikelele lwemfundo kunye nokuthengwa kwempahla. Ayiyongcebiso yezonyango, ubuchule botyando, ukuleyibhelishwa kwemveliso okanye endaweni ye-IFU esebenzayo. Izigqibo zonyango kufuneka zenziwe ngabasebenzi bezempilo abaqeqeshiweyo. Ukufumaneka kwemveliso, usetyenziso olucetywayo, ubume bobhaliso kunye namaxwebhu anokwahluka ngokwentengiso kunye noqwalaselo; ziqinisekise phambi kokuthenga okanye ukuzisebenzisa.
Vavanya i-Pedicle Screw System kwiMarike yakho
Xelela i-XC Medico imarike yendawo oya kuyo, ummandla womqolo ofunekayo, uhlobo lwenkqubo ekhethwayo kunye neemfuno zamaxwebhu. Cela uluhlu lwecandelo elithile lemveliso, ulungelelwaniso lwesixhobo kunye nolwazi olukhoyo lolawulo phambi kokuthelekisa iikowuteshini.
Cela amaxwebhu enkqubo
