Pedicle screws, rods thiab locking Cheebtsam tsim ib qho kev txhim kho tom qab kev tsim kho uas tuaj yeem ua kom ruaj khov ntawm cov leeg txha caj qaum thaum fusion tsim. Kev xaiv cov txheej txheem yuav tsum yog raws li kev kho lub cev, kev siv lub hom phiaj, tsim cov phiaj xwm, cov pob txha zoo, cov cuab yeej siv tau zoo thiab cov ntaub ntawv ntawm cov khoom lag luam tshwj xeeb.
Dab tsi yog Pedicle Screws?
Pedicle screws yog implantable fixation Cheebtsam tso los ntawm ib tug vertebral pedicle rau hauv lub cev vertebral. Thaum txuas nrog longitudinal rods, lawv muab cov ntsiab lus thauj tog rau nkoj rau kev tsim kho tus txha caj qaum. Nyob ntawm cov txheej txheem tshwj xeeb thiab nws cov ntawv sau tau npaj siv, pedicle ntsia hlau tsim yuav raug siv los ua ib feem ntawm cov txheej txheem hais txog kev tsis sib haum xeeb lossis deformity uas yuav tsum tau fusion nrog instrumentation.
Lo lus 'pedicle ntsia hlau' piav qhia txog pawg, tsis yog ib qho kev cog lus universal. Cov txheej txheem sib txawv hauv cov ntsia hlau tsim, txoj kab uas hla thiab qhov ntev, qhov taub txoj kab uas hla, ntsuas qhov ntsuas, cov khoom siv, cov twj paj nruag, ntxig cov haujlwm thiab cov lus pom zoo. Cov ntsiab lus no yuav tsum tau lees paub nyob rau hauv cov ntaub ntawv rau qhov tseeb qhov system raug tshuaj xyuas.
Dab tsi ua rau Pedicle Screw Construct?
Kev tsim ua tiav ib txwm muaj ntau dua li cov ntsia hlau nws tus kheej. Cov ntsiab lus tseem ceeb sib txawv los ntawm cov chaw tsim khoom thiab qhov system, tab sis kev ntsuam xyuas feem ntau suav nrog cov pawg hauv qab no.
| Cheebtsam qeb | General lub luag haujlwm hauv kev tsim | Cov neeg yuav khoom yuav tsum txheeb xyuas |
|---|---|---|
| Pedicle ntsia hlau | Muab cov thauj tog rau nkoj hauv lub vertebra | Tsim, qhov ntev, npaj thaj tsam qaum, cov khoom specification thiab daim ntawv lo |
| Qws | Txuas anchors hla cov qib kho | Txoj kab uas hla, muaj qhov ntev lossis cov ntawv, cov khoom siv thiab kev sib raug zoo nrog lub taub hau ntsia hlau |
| Locking tivthaiv | Secures tus pas nrig hauv lub taub hau ntsia hlau | Xauv ib ntus, xav tau tsav tsheb, cov lus qhia torque thiab kev siv ib zaug |
| Cov khoom sib txuas | Tej zaum yuav txuas ntxiv lossis txuas qhov chaw ntawm ib qho kev tsim kho thaum suav nrog hauv qhov system | Pom zoo configurations thiab system-specific compatibility |
| Insertion instruments | Txhawb kev npaj, ntsia hlau ntxig, pas nrig tso thiab zaum kawg xauv | Daim ntawv teev cov cuab yeej, tais layout, tu, hloov thiab reprocessing cov lus qhia |
Distributors yuav tsum tsis txhob cuam tshuam qhov sib txawv ntawm qhov sib xws los yog qhov zoo sib xws. Cov khoom siv thiab cov cuab yeej siv los ntawm cov tshuab sib txawv yuav tsum tsis txhob sib xyaw tshwj tsis yog tias qhov kev siv no tau lees paub los ntawm cov ntaub ntawv tsim khoom lag luam thiab cov kev xav tau.
Yuav ua li cas Pedicle Screw Fixation Txhawb Spinal Fusion
Spinal fusion aims los tsim cov pob txha txuas ntxiv ntawm cov vertebrae xaiv. Lub pedicle ntsia hlau-thiab-rod tsim tuaj yeem txo cov lus tsa suab ntawm cov ntsuas ntsuas thiab tswj kev sib raug zoo ntawm vertebrae thaum fusion tsim. Lub tsev yog li ntawd txhawb lub fusion ib puag ncig; nws tsis yog ib qho kev hloov rau kev npaj pob txha, graft lub tswv yim lossis kev kho mob lom.
Cov txiaj ntsig kho mob tsis tuaj yeem kwv yees los ntawm cov ntsia hlau ib leeg. Cov txiaj ntsig tuaj yeem cuam tshuam los ntawm kev kuaj mob, qib txha caj qaum, txoj hauv kev phais, kev tsim kho, pob txha zoo, kev cog qoob loo, kev xaiv graft, kev haus luam yeeb, comorbidities, ua raws li cov lus qhia tom qab phais thiab lwm yam. Vim li no, nplooj ntawv cov khoom lossis cov lus qhia yuav tsum tsis txhob cog lus tias yuav muaj qhov sib txawv tshwj xeeb, txo qhov mob lossis lub sijhawm rov qab los.
Thoracolumbar thiab Cervical siv yuav tsum tau ntsuas cais
Pedicle morphology, ib puag ncig cov qauv, cov tswv yim kho thiab cov tshuab muaj sib txawv nyob ntawm tus txha nraub qaum. Ib nqe lus dav dav uas ib qho ntsia hlau ua haujlwm rau 'caj dab thiab sab nraub qaum' yog li tsis txaus rau kev txiav txim siab kho mob lossis kev yuav khoom.
Thoracolumbar constructs yuav siv qhib los yog percutaneous pedicle ntsia hlau tshuab. Cov neeg yuav khoom yuav tsum txheeb xyuas cov ntawv sau npe anatomical, ntsia hlau thiab pas nrig ntau, kev xaiv txo qis, cov cuab yeej siv tau zoo thiab cov txheej txheem tshwj xeeb.
Cervical pedicle fixation yuav tsum muaj qhov sib txawv anatomical kev txiav txim siab thiab yuav tsum tsis txhob muab los ntawm cov ntaub ntawv lumbar. Paub meej tias seb qhov kev ntsuam xyuas yog tshwj xeeb rau lub ncauj tsev menyuam lossis cheeb tsam occipitocervical-thoracic thiab tshuaj xyuas nws cov txheej txheem thiab cov cuab yeej tshwj xeeb.
XC Medico teev cov khoom lag luam tom qab lub ncauj tsev menyuam cais, suav nrog a posterior cervical fixation system . Nws cov specifications, npaj siv thiab compatibility yuav tsum tau soj ntsuam ntawm nws tus kheej los ntawm thoracolumbar pedicle ntsia hlau tshuab.
Common Pedicle Screw Designs
Cov ntsiab lus hauv qab no piav qhia cov qauv tsim qauv thoob plaws hauv kev lag luam. Lawv tsis tsim cov yam ntxwv ntawm XC Medico cov khoom tshwj xeeb tshwj tsis yog tias muaj kev lees paub ntawm nplooj ntawv cov khoom lag luam thiab cov ntaub ntawv thev naus laus zis.
| Tsim qeb | General yam ntxwv | Kev ntsuam xyuas taw tes |
|---|---|---|
| Monoaxial | Lub taub hau ntsia hlau muaj ib qho kev sib raug zoo rau cov ncej | Txheeb xyuas qhov kev thov tsim kho thiab cov kev xav tau ntawm cov pas nrig sib dhos |
| Polyaxial | Lub taub hau tuaj yeem hais tawm ua ntej kaw qhov kawg | Tshawb xyuas angulation ntau yam, ntsuas phoo mechanism thiab cov cuab yeej siv tau |
| Txo cov ntsia hlau | Lub taub hau txuas ntxiv tuaj yeem pab txo qis ua ntej kev sib dhos zaum kawg | Txheeb xyuas qhov ua haujlwm txo qis, txoj kev tshem tawm tab thiab cov cuab yeej tshwj xeeb |
| Khoom ntsia hlau | Tsim los rau kev nkag los ntawm qhov system qhov kev npaj ua haujlwm | Paub meej tias cov kais dej, kev sojntsuam, tsav tsheb thiab kev nkag mus ib ntus |
| Cannulated ntsia hlau | Muaj lub hauv paus channel uas tuaj yeem txhawb nqa cov lus qhia raws li kev nkag | Paub meej tias cov lus qhia, dilator thiab cov duab ua haujlwm, ntxiv rau cov lus ceeb toom |
Screw txoj kab uas hla, ntev thiab trajectory tsis 'loj yog ib txwm zoo' kev txiav txim siab. Lawv raug xaiv los ntawm kev siv lub cev, cov pob txha zoo, kev kos duab, kev tsim kho, kev txiav txim ntawm tus kws phais thiab cov kev txwv ntawm cov txheej txheem xaiv.
Qhib vs. Minimally Invasive Pedicle Screw Systems
Qhib thiab percutaneous systems tuaj yeem ua ob qho tib si tsim kho tom qab, tab sis lawv txoj kev nkag mus, kev cog qoob loo thiab cov cuab yeej ntsuas sib txawv. 'Minimally invasive' piav qhia txog kev ua haujlwm thiab kev ua haujlwm; nws yuav tsum tsis txhob siv raws li kev cog lus thoob ntiaj teb ntawm cov txiaj ntsig kev kho mob zoo dua rau txhua tus neeg mob lossis kev qhia.
| Kev ntsuam xyuas cheeb tsam | Qhib system | Percutaneous/MIS system |
|---|---|---|
| Nkag mus | Direct exposure ntawm cov ntsiab lus tom qab | Cov kev nkag me me uas siv cov cuab yeej xa khoom tshwj xeeb |
| Ntsia hlau ntxig | Lub kaw lus tshwj xeeb qhib kev npaj thiab tso cov twj paj nruag | Feem ntau siv guidewire- thiab imaging-dependent cov kauj ruam thaum tau teev tseg |
| Qws xa khoom | Qws positioned los ntawm qhov raug tsim | Dedicated percutaneous pas nrig-xa khoom ua haujlwm |
| Cov cuab yeej xav tau | Qhib lub tais thiab tsim-manipulation instruments | Dilators, tes tsho, towers lossis extenders thiab MIS qws seev raws li muaj feem xyuam |
| Cov lus nug tseem ceeb ntawm kev yuav khoom | Puas yog tag nrho qhib ntsuas kev teeb tsa muab? | Puas yog tag nrho cov kev nkag, kev taw qhia, kev txo qis thiab cov khoom xa tuaj nrog? |
Rau ib qho piv txwv tshwj xeeb ntawm qhov system, tshuaj xyuas qhov minimally invasive pedicle screw system nplooj ntawv thiab thov nws cov lus qhia tam sim no, daim ntawv teev cov cuab yeej thiab cov ntaub ntawv ua ntej txiav txim siab kev sib raug zoo lossis kev txiav txim siab kev lag luam.
Cov yam ntxwv siv los xaiv Pedicle Screw System
Kev xaiv kho mob yog nyob rau hauv pab neeg kho mob. Pab pawg neeg yuav khoom txhawb nqa qhov kev txiav txim siab los ntawm kev lees paub tias qhov kev thov kev teeb tsa tau ua tiav, sau tseg thiab tsim nyog rau lub khw muag khoom.
Clinical thiab technical factor
- Spinal cheeb tsam thiab qib suav nrog hauv kev tsim
- Kev kuaj mob, instability lossis deformity hais los ntawm cov txheej txheem npaj
- Pedicle morphology, muaj pob txha txoj kev hauv tsev thiab npaj trajectory
- Cov pob txha zoo thiab txhua qhov kev txwv tshwj xeeb
- Qhib, percutaneous lossis lwm yam kev npaj phais mob
- Yuav tsum tau ntsia hlau-lub taub hau tus cwj pwm, txo cov tswv yim thiab tus pas nrig configuration
- Kev cob qhia kws phais thiab kev paub txog qhov tseeb
- Daim ntawv lo, indications, contraindications, ceeb toom thiab ceev faj
Yam khoom thiab kev faib khoom
- Ua kom tiav cov ntsia hlau thiab pas nrig ntau yam xav tau rau cov rooj plaub npaj
- Pom zoo compatibility ntawm implants, xauv qhov chaw thiab cov cuab yeej
- Instrument tray tiav, tshuaj xyuas thiab hloov txheej txheem
- Sterile lossis non-sterile khoom raws li txoj cai thiab cov ntaub ntawv siv tau
- Labeling, traceability, ntau tswj thiab ntim configuration
- Kev ua lag luam tshwj xeeb rau kev sau npe thiab kev ua haujlwm-cov ntaub ntawv muaj
- Hloov-kev ceeb toom lub luag hauj lwm thiab version tswj
- Kev kwv yees, rov ua dua lub sijhawm ua ntej thiab cov khoom lag luam tseem ceeb-loj
Muaj peev xwm txaus ntshai thiab pov thawj txwv
Cov teeb meem uas muaj feem cuam tshuam nrog kev sib txuas ntawm tus txha caj qaum tuaj yeem muaj xws li malposition, neurological los yog vascular raug mob, loosening, pullout, implant deformation los yog breakage, kab mob, tsis kho, nonunion thiab xav tau kev kho. Qhov no tsis yog ib daim ntawv teev tag nrho. Daim ntawv lo uas siv tau yuav tsum tau siv rau nws cov lus qhia ua tiav, contraindications, ceeb toom, ceev faj thiab cov ntaub ntawv tsis zoo-xws li.
Kev tso kawm technology yog ib qho chaw uas pov thawj yuav tsum tau piav qhia kom zoo. Ib xyoo 2024 kev tshuaj xyuas thiab kev tshuaj xyuas meta-txhim kho ntawm thoracolumbar fixation tau tshaj tawm qhov sib txawv me me hauv qhov chaw kho mob tau txais cov ntsia hlau nruab nrab ntawm pawg navigated thiab ib txwm muaj, thaum pom tsis muaj qhov sib txawv ntawm qhov mob lossis qhov tsis taus. Ib qho kev tshuaj xyuas cais ntawm ncauj tsev menyuam pedicle screws tsis pom qhov tseem ceeb ntawm kev qhia txog qhov tseeb. Cov txiaj ntsig no yuav tsum tsis txhob muab tso ua ke rau hauv kev thov thoob ntiaj teb uas kev taw qhia ib txwm txhim kho txhua qhov kev phais lossis tus neeg mob tau txais txiaj ntsig.
Pedicle Screw System Checklist rau Distributors
Ua ntej thov cov lus hais zaum kawg lossis tsim ib lub phiaj xwm sau npe hauv zos, nug cov pov thawj khi rau tus qauv thiab kev ua lag luam. Cov npe hauv qab no yog qhov pib thiab yuav tsum tau ua raws li cov cai hauv zos.
| Tshawb xyuas qeb | Cov Lus Nug los nug | Cov Ntaub Ntawv Thov |
|---|---|---|
| Qhov System Scope | Qhov kev cog qoob loo thiab cov cuab yeej twg tsim kom tiav qhov system? | Cov catalog tam sim no, daim ntawv teev cov khoom siv thiab cov npe ntsuas |
| Npaj siv | Qhov twg anatomical cheeb tsam, cov xwm txheej thiab cov neeg siv tau them? | Kev lag luam tshwj xeeb daim ntawv lo, IFU thiab cov ntaub ntawv pov thawj |
| Qhov ntev | Puas yog qhov yuav tsum tau muaj cov ntsia hlau, pas nrig thiab qhov txuas txuas muaj? | Txheeb xyuas cov ntawv qhia tshwj xeeb thiab xaj xaj xaj |
| Kev sib haum xeeb | Cov khoom siv twg tuaj yeem siv ua ke? | Chaw tsim tshuaj paus compatibility matrix los yog tswj cov ntaub ntawv |
| Khoom siv | Cov khoom siv dab tsi siv rau txhua qhov cog cog? | Cov khoom specification thiab cov ntaub ntawv pov thawj conformity |
| Cov cuab yeej | Puas yog lub tais npog npaj, ntxig, txo qis thiab kaw qhov kawg? | Lub tais layout, cov npe ntsuas thiab cov lus qhia txog kev saib xyuas |
| Khoom siv configuration | Cov khoom puas muaj menyuam tsis taus lossis tsis muaj menyuam, thiab nws ntim li cas? | Ntim configuration, labeling thiab tuav cov ntaub ntawv |
| Traceability | Cov qauv, qhov loj thiab ntau npaum li cas txheeb xyuas los ntawm kev faib khoom? | Sample daim ntawv lo, traceability record thiab kev tsis txaus siab workflow |
| Hloov tswj | Cov khoom, txheej txheem, tus neeg muag khoom lossis cov ntawv sau hloov pauv li cas? | Daim ntawv cog lus zoo thiab cov lus ceeb toom hloov pauv |
Tshawb XC Medico Pedicle Screw System Nplooj ntawv
Cov kev sib txuas hauv qab no yog cov ntsiab lus pib rau kev soj ntsuam cov khoom, tsis yog cov lus hais tias cov tshuab hloov pauv tau lossis tsim nyog rau tus neeg mob tshwj xeeb. Tshawb xyuas cov ntaub ntawv tam sim no rau qhov kev teeb tsa tiag tiag uas koj xav tau.
Xauj qhov dav XC Medico cov khoom lag luam ua ntej nqaim qhov xav tau kev teeb tsa.
Tshawb xyuas nplooj ntawv khoom tshwj xeeb thiab thov nws cov khoom tam sim no thiab cov ntaub ntawv ntsuas.
Ntsuam xyuas qhov system ntawm nws tus kheej rau qhov muaj, muaj kev teeb tsa thiab cov ntaub ntawv.
Txheeb xyuas qhov ua tiav ntawm lub tais thiab paub meej tias txhua qhov cuab yeej sib xws nrog cov txheej txheem cog qoob loo uas tau xaiv.
Yog xav paub ntxiv txog kev cog thiab cov cuab yeej siv, mus saib XC Medico's spinal fixation daws.
Cov lus nug nquag
Dab tsi yog lub luag haujlwm ntawm pedicle screws hauv spinal fusion?
Pedicle screws ua raws li cov thauj tog rau nkoj rau cov pas nrig-raws li kev tsim kho. Kev tsim kho txwv tsis pub txav mus los thiab tswj xyuas qhov kev npaj ua kom zoo thaum lub sij hawm lom neeg fusion tsim. Cov screws lawv tus kheej tsis tsim fusion.
Cov khoom siv dab tsi ua rau lub pedicle ntsia hlau tsim?
Ib qho kev tsim feem ntau suav nrog cov ntsia hlau pedicle, rods thiab cov khoom siv xauv, nrog cov khoom sib txuas lossis cov khoom txo qis qhov twg qhov tshwj xeeb tso cai. Cov cuab yeej tshwj xeeb yog xav tau rau kev npaj, ntxig, tso pas nrig thiab zaum kawg xauv.
Qhov txawv ntawm qhov qhib thiab MIS pedicle ntsia hlau tshuab yog dab tsi?
Lawv txawv tsuas yog hauv kev nkag mus, cog kev xa khoom thiab ntsuas kev ua haujlwm. Percutaneous systems feem ntau xav tau kev nkag mus rau kev nkag siab thiab cov cuab yeej xa khoom. Tsis yog txoj hauv kev yuav tsum tau piav qhia tias yog qhov zoo tshaj plaws rau txhua qhov kev qhia lossis tus neeg mob.
Cov khoom ntawm cov ntsia hlau sib txawv tuaj yeem sib xyaw?
Tsis txhob xav tias compatibility los ntawm qhov zoo sib xws los yog zoo li. Tsuas yog siv cov kev teeb tsa uas txhawb nqa los ntawm cov ntaub ntawv tsim khoom lag luam uas cuam tshuam thiab siv cov kev cai tswj hwm.
Cov ntaub ntawv dab tsi yuav tsum thov rau tus xa khoom?
Thov cov ntawv teev npe tam sim no thiab cov lej xaj, cov npe thiab cov cuab yeej siv, cov lus qhia tshwj xeeb, daim ntawv lo thiab IFU, cov ntaub ntawv cov ntaub ntawv, kev ntim khoom, cov ntaub ntawv taug qab thiab cov ntaub ntawv tswj hwm kev lag luam muaj feem xyuam rau cov khoom siv.
Cov ntaub ntawv siv thiab pov thawj Scope
- US FDA. Kev taw qhia rau Kev Lag Luam thiab Cov Neeg Ua Haujlwm FDA: Spinal System 510(k)s.
- Papalia GF, et al. Navigated thoracolumbar pedicle ntsia hlau fixation piv rau cov txheej txheem ib txwm: kev tshuaj xyuas thiab kev tshuaj xyuas meta. qaum. 2024.
- Muab tso rau hauv thiab kho kom raug rau lub ncauj tsev menyuam pedicle screws muab tso nrog los yog tsis muaj navigation: systematic tshuaj xyuas thiab meta-analysis. 2023.
- Perdomo-Pantoja A, thiab al. Qhov tseeb ntawm cov txheej txheem tam sim no rau kev tso ntawm pedicle screws nyob rau hauv tus txha nraub qaum: kev tshuaj xyuas thiab kev tshuaj xyuas meta. qaum. 2019.
Kev tsis lees paub txog kev kho mob thiab kev tswj hwm: Kab lus no qhia txog kev kawm thiab kev yuav khoom. Nws tsis yog cov lus qhia txog kev kho mob, cov txheej txheem phais mob, kev sau npe khoom lossis kev hloov pauv rau IFU siv tau. Kev txiav txim siab kho mob yuav tsum yog los ntawm cov kws kho mob uas tsim nyog. Cov khoom muaj, npaj siv, kev sau npe thiab cov ntaub ntawv tuaj yeem sib txawv raws li kev lag luam thiab kev teeb tsa; txheeb xyuas lawv ua ntej yuav khoom lossis siv.
Ntsuam xyuas Pedicle Screw System rau Koj Lub Lag Luam
Qhia rau XC Medico koj qhov chaw ua lag luam, xav tau thaj tsam qaum teb, hom kab ke nyiam thiab cov ntaub ntawv xav tau. Thov ib daim ntawv teev cov khoom tshwj xeeb, kev teeb tsa cov cuab yeej thiab cov ntaub ntawv tswj hwm muaj nyob ua ntej sib piv cov lus hais.
Thov cov ntaub ntawv system
