Dizayini leyintshwa ya R&D

MIS | Ku Ndlandlamuxiwa ka Thekinoloji - Swipfuno swa Thekinoloji - Mimbuyelo ya le ndzhaku ka vuhandzuri | czmeditech ya xitsonga

Minimally Invasive Spine System (MIS) i thekinoloji ya xiyimo xale henhla leyi endlaka leswaku kuva na vutshunguri lebyi kongomeke hiku tsemiwa lokuntsongo eka swiyimo swofana na ti herniated discs na spinal stenosis.

Vuxokoxoko lebyintshwa bya dizayini

Swipfuno leswi nga ngheneriki ngopfu

Ku hungutiwa ka ku vaviseka

Dizayini ya ku tsemiwa lokutsongo:

Ku tsemiwa loku tolovelekeke i 1-2 cm ntsena, leswi hungutaka ku hluvula ka misiha na ku onhaka ka tinyama to olova.

Thekinoloji yo veka ndhawu hi ku kongoma:

Ku antswisiwa ka ku pakanisa ka ku vekiwa ka xirho lexi nghenisiweke hi ku fambafamba ka le ndzeni ka vuhandzuri (xikombiso O-arm, 3D-C-arm) kumbe mpfuneto wa robotic (xikombiso Mazor X, Globus Medical).

Ku hunguteka ka ku huma ngati loko ku endliwa vuhandzuri:

thekinoloji ya mfikelelo leyi nga ngheneriki ngopfu yi hunguta khombo ra ku vaviseka ka misiha, ngopfungopfu eka vavabyi lava dyuhaleke kumbe lava nga na vuvabyi byin’wana.

Ku hatlisa ku hola endzhaku ka vuhandzuri

Ku tshama nkarhi wo koma exibedlhele:

vavabyi votala va humesiwa 24-48 wa tiawara endzhaku ka vuhandzuri, loko ku pimanyisiwa na 3-5 wa masiku eka vuhandzuri bya ndhavuko lebyi pfulekeke.

Ku famba-famba ka ha ri ni nkarhi:

Ku vava kutsongo na nsirhelelo wo antswa wa misiha swi pfumelela vavabyi ku tlhelela eka mintirho ya vona ya siku na siku hi ku hatlisa.

Ku antswisiwa ka biomechanical

Switirhisiwa leswintshwa swa swilo leswi vonakaka:

xikombiso 3D printed titanium alloys, PEEK (polyether ether ketone) switirhisiwa ku fikelela modulus ya elasticity ekusuhi na ya marhambu na ku hunguta stress masking.

Tisisiteme ta ku tiyisisa leti cinca-cincaka:

swin’wana leswi nghenisiweke (xikombiso Dynesys, Coflex) swi hlayisa ku fambafamba ka nkolo naswona swi hunguta khombo ra ku onhaka ka xiphemu lexi nga ekusuhi.

Swikombiso leswi andlariweke

Ku katsa nxaxamelo wo anama wa mavabyi ya nkolo ku fana na vuvabyi bya degenerative disc, lumbar spinal stenosis, mild spondylolisthesis na ku tshoveka ka vertebral.

临床案列

Leswi landzelaka i timhaka ta ndzavisiso lowu yimelaka eka malembe ya sweswinyana:

1. Ndzavisiso lowu lawuriwaka hi ku landzelelana wa ku hlanganisiwa ka nkolo wa le ndzhaku (TLIF) .

Dizayini ya dyondzo:

prospective multicenter RCT (2022) leyi pimanisaka MIS-TLIF (leyi nga ngheneriki ngopfu) na TLIF leyi pfulekeke.

Vukulu bya xikombiso: .

Vavabyi va 120 lava nga ni vuvabyi bya xiphemu xin’we lebyi onhaka nkolo wa le ndzhaku.

Mimbuyelo:

Nkarhi wa vuhandzuri:

ku leha nyana eka ntlawa wa MIS (swi vula 150 min vs. 130 min), kambe 60% kutsongo ku huma ngati (<100 ml vs. 250 ml).

Ku vava endzhaku ka vuhandzuri: .

Ku hunguteka ka 50% eka swikoweto swa VAS vhiki rin’we endzhaku ka vuhandzuri eka ntlawa wa MIS, ku hava ku hambana lokukulu exikarhi ka mintlawa leyimbirhi endzhaku ka tin’hweti ta 3.

Mpimo wa ku hlanganisiwa: .

1 year postoperative CT yi kombisile >90% fusion rate eka mintlawa leyimbirhi.

Swiphiqo: .

Mpimo wa ku tluleriwa 2% eka ntlawa wa MIS vs. 8% eka ntlawa lowu pfulekeke.

2. Dyondzo ya nkarhi wo leha yo landzelerisa ya sisiteme ya ku tiyisisa ku cinca-cinca (Coflex) .

Dizayini ya dyondzo:

Dyondzo ya ku landzelerisa ya malembe ya 5 ya le Yuropa (2021) leyi kambelaka ku vekiwa ka Coflex eka vutshunguri bya lumbar spinal stenosis.

Vukulu bya xikombiso: .

80 wa vavabyi.

MBUYELO:

Ku antswisiwa ka ntirho: .

ODI (dysfunction index) yi hungutekile ku suka eka 45 wa tinhla eka masungulo ku ya eka 20 wa tinhla eka 5 wa malembe.

KU ONHISIWA KA XIYENGE XA LE VAKENI: .

I 12% ntsena wa vavabyi lava nga va na swiphiqo swa xiphemu xa le kusuhi, leswi nga ehansi swinene ku tlula fusion leyi tolovelekeke (~30%).

Mpimo wa vuhandzuri nakambe: .

ku hlengeletiwa ka 5-year reoperation rate ya 8%, ngopfu ngopfu hikwalaho ka ku ntshunxeka ka implant (4%) kumbe ku tlhekeka ka swikombiso.

3. Dyondzo ya tisenthara to tala ya switirhisiwa swa MIS leswi pfuniwaka hi tirhoboto

Dizayini ya dyondzo:

dyondzo ya retrospective leyi kandziyisiweke hi 2023 ku xopaxopa mbuyelo wa ku vekiwa ka swikwirikiri swa MIS hi mpfuneto wa tirhoboto wa Mazor.

Vukulu bya xikombiso: .

500 wa ku vekiwa ka swikwirikiri (thoracolumbar spine).

Mimbuyelo:

Ku kongoma: .

98.6% wa swiyimo swa swikwirikiri a swi eneriseka (Gertzbein-Robbins grading A/B).

Swiphiqo: .

nerve root injury rate 0.4% loko ku pimanyisiwa na 3-5% eka ku vekiwa ka freehand loku tolovelekeke.

Ku kuma vutivi byo tala bya swikumiwa na vuxokoxoko, hi kombela u hi tihlanganisa!