I-MEDICA: Umatshini we-TRIANGEL's Proctology Diode Laser one-FDA kunye ne-CE Clearance kwiiKliniki zotyando zeHlabathi

Kwi-MEDICA eDuesseldorf, umboniso wezonyango ophambili kwihlabathi liphela, umenzi we-laser okhethekileyo i-TRIANGEL uveze indawo yakhe yokusebenza yotyando ye-V6 proctology ephucukileyo. Amaziko otyando oluhambahambayo kunye namasebe e-colorectal ezibhedlele asebenzisa iindlela zamandla ezingaphantsi kakhulu ezigcina ukuthembeka kwe-sphincter kwaye zikhawulezise ukuphinda ziphile. Utyando lwendabuko lwe-hemorrhoidectomy ludla ngokubandakanya ukususwa kwezicubu ezibuhlungu, amaxesha okuphiliswa okwethutyana, kunye nokuphazamiseka okunokwenzeka kwi-continence yendalo. Yasekwa ngo-2013, i-TRIANGEL isebenza phantsi kwemigangatho eqinisekisiweyo ye-ISO 13485, ivelisa ii-consoles zotyando eziphambili eziphethe imvume ye-FDA kunye nesatifikethi se-European Medical CE.Umatshini we-laser we-FDA kunye ne-CE ococekileyo we-proctology diode laserIbonelela nge-endoluminal photocoagulation ejolise kuyo, ukugcinwa kwe-sphincter, kunye nokuthembeka kwe-mucosal kuzo zonke ii-suite zotyando zangaphandle. Le ndawo yokusebenza ikhethekileyo ivumela oogqirha botyando lwe-colorectal ukuba benze i-laser hemorrhoidoplasty echanekileyo kunye nokuvalwa kwe-fistula ngaphakathi kweshedyuli yotyando elungelelanisiweyo. Iziko lezempilo landisa ubungakanani beemeko zabo zotyando ngelixa ligcina iziphumo zeklinikhi eziqikelelweyo kunye nolwaneliseko oluphezulu lwesigulana.

Ukugcinwa kweSphincter kunye noBulungisa beMucosal kwiLaser Hemorrhoidoplasty

I-Laser Hemorrhoidoplasty (LHP) imele utshintsho oluqhelekileyo lwezonyango kulawulo lotyando lwesifo se-hemorrhoidal esineempawu zeBanga lesi-2, lesi-3, nelesi-IV. Iqonga le-TRIANGEL V6 lisebenzisa ii-American QPC semiconductor diode arrays zokuqala ezikhupha i-laser emissions eyi-1470 nm kunye ne-980 nm. Ikhokelwa zii-fibers ze-silica ezingama-400 ukuya kuma-600 micrometer, ugqirha wotyando ungenisa amandla okukhanya ngqo kwi-submucosal hemorrhoidal cushion.

Ubude be-1470 nm busebenzisana ngokukhetha namanzi angaphakathi kweseli kunye nangaphakathi ngaphakathi kwe-hyperplastic vascular cushions, nto leyo eqala ukuguquka kweproteni elawulwayo kwi-55 degrees Celsius. Kwangaxeshanye, ukukhutshwa kwe-980 nm kudibana ne-oxyhemoglobin yangaphakathi kwemithambo ukuze kube lula ukucoca i-microvascular hemostasis ecaleni kwendlela yonyango. La mandla e-endoluminal avuselela ukuvuselelwa kwe-collagen kwaye anamathele kwi-mucosa ngokuqinileyo kwizakhiwo zemisipha ezingaphantsi—ukususa i-nodule prolapse ngaphandle kokufuna ukusika okungafunekiyo, ukuxhuzula i-rubber band, i-mechanical staples, okanye izinto zokuthunga zangaphandle. Ngenxa yokuba amandla okukhanya athunyelwa ngokupheleleyo phantsi kwe-anoderm, i-anal mucosa ebuthathaka kunye nemisipha ye-anal sphincter yangaphakathi ihlala igcinwe ngokupheleleyo.

Amandla obushushu alawulwayo abangela ukushwabana kwangoko kwe-hemorrhoidal node, kulandele i-fibrosis yezicubu ezidibeneyo ezizinzileyo kwiiveki ezilandelayo. Iindlela zokuhambisa eziqhubekayo kunye ne-pulsed zivumela oogqirha ukuba balungise iiparameter zamandla ngokuchaneka kwinqanaba le-millimeter kwiivectors ezahlukeneyo ze-anatomical. Izigulana azifumani ntlungu ingako emva kotyando, zifuna amayeza amancinci okuthomalalisa iintlungu kwaye ziphinde ziqalise imisebenzi eqhelekileyo yemihla ngemihla kwiintsuku enye ukuya kwezimbini. Ukulandelelana kweklinikhi ixesha elide kuqinisekisa amazinga aphezulu okusombulula iimpawu ngaphandle kwe-anal stenosis okanye iingxaki zokungakwazi ukuzibamba.

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Izixhobo ezikhethekileyo ze-Optical zeenkqubo ze-FiLaC kunye ne-SiLaC

Ngaphaya kokususwa kwe-hemorrhoidal, i-V6 workstation inika uncedo olusebenzayo lwezonyango kwiimeko ezinzima ze-anorectal kunye ne-pilonidal. Kunyango lwe-anal fistula, le nkqubo ixhasa i-Fistula-tract Laser Closure (FiLaC) isebenzisa iifayibha ezibonakalayo ze-radial-emitting optical ze-360-degree. Ugqirha ufaka ifayibha ye-radial ecaleni kwendlela ye-fistula phantsi kolwalathiso olubonakalayo oluvela kumqadi obomvu odibeneyo we-650 nm.

Njengoko ugqirha ekhupha kancinci ifayibha, amandla e-radial abeka isangqa esifanayo samandla obushushu angama-360 kwiindonga zendlela. Oku kufudumeza okulawulwayo kususa i-epithelial lining enesifo kwaye kuqalise ukushwabana kwe-collagen ejikelezayo ngaphandle kokufuna ukwahlukana kwe-sphincter. Umnyango wangaphakathi oyintloko uvalwa nge-flap yokuqhubela phambili okanye i-mucosal suture, okugcina i-fecal continence epheleleyo.

Ngokufanayo, kwiSinus Laser Closure (SiLaC) ye-pilonidal sinus tracts, i-radial fiber ivumela ukuqhekeka kwe-endoluminal ngokupheleleyo ngokusebenzisa imicu emincinci. Ngokuphepha ukususwa kotyando olubanzi, i-SiLaC igcina uyilo lwezicubu ezikufutshane kwaye igwema iindlela zokupakisha amanxeba avulekileyo ezibuhlungu. Xa kuthelekiswa ne-CO2 esasazeka kakhulu okanye amaqonga e-Nd:YAG angena nzulu, i-V6 inika indawo yokufudumeza enganzulu, evalekileyo kakhulu esebenza ngaphandle komsi okanye iintlantsi ngexesha lotyando, ikhulisa ukubonakala kwentsimi yokusebenza. Uluhlu lwefayibha elahlwayo ye-TRIANGEL engenazintsholongwane luquka iincam ezingenanto ze-conical kunye nolungelelwaniso lwe-radial, oluhlangabezana neemfuno ezahlukeneyo ze-anatomical kunye nokuhambelana okuphezulu kwenkqubo. Izihlanganisi ze-optical eziqhelekileyo ze-SMA905 ziqinisekisa ukuhlanganiswa kwangoko kunye nokudluliselwa kwe-laser rhoqo ngexesha lokuqhuba utyando olubuthathaka.

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Uqinisekiso oluHlanganisiweyo lweMithetho: I-EU Medical CE kunye ne-United States FDA Clearance

Abalawuli bokuthengwa kweenkonzo zempilo zamazwe ngamazwe kunye neentloko zamasebe otyando bafuna iziqinisekiso zomthetho ezibhaliweyo xa bekhetha izixhobo zonyango eziwela imida. I-TRIANGEL iqinisekisa inkqubo yolawulo lomgangatho ye-ISO 13485:2016 elawula ukuhlanganiswa kwe-optoelectronic, ukuveliswa kwegumbi lokucoca, kunye novavanyo lwamandla okukhanya. Isebe elizinikeleyo lokuqinisekisa umgangatho elineengcali ezili-12 lenza uhlolo lwamanqanaba amaninzi ukugcina uzinzo lwebhetshi kuyo yonke imigca yemveliso.

Iqonga le-V6 proctology linelungelo lokufumana imvume ye-FDA 510(k) yase-United States, liqinisekisa ukuthotyelwa kwemigangatho yokusebenza kweklinikhi kunye nokhuseleko oluqinileyo. EYurophu, iqonga lifumene isiqinisekiso se-Medical CE phantsi koMgaqo weZixhobo zoNyango (i-MDR), ohlolwe yiBritish Standards Institution (BSI 2797).

Ukongeza, ukubhaliswa kweemveliso okusemthethweni ne-UKCA kunye ne-Brazilian ANVISA kwenza abasasazi bezonyango behlabathi lonke bandise ukufikelela kwimarike yengingqi ngokutyibilikayo. Ezi mvume zimbini ziqinisekisa ukuba iinkqubo zotyando ze-TRIANGEL ziyahlangabezana nemigangatho ephezulu yamazwe ngamazwe yokuthembeka kwezonyango. Abasasazi kunye nezibhedlele bafumana izixhobo zonyango eziqinisekisiweyo ezidityaniswe neendawo zemidlalo yeqonga ezivunyiweyo ngaphandle kokulibazisa. Ukuthobela imithetho ebhaliweyo kubonelela amaziko ezempilo ngoxolo lwengqondo olulawulayo kwiindawo ezahlukeneyo zejografi.

Inkqubo yotyando edibeneyo kunye noQoqosho oluhambahambayo

Kwiisuti zotyando lwasemini ezingalaliswanga kunye neeklinikhi ezikhethekileyo zeproctology, i-V6 workstation inika ukusebenza kakuhle okuphezulu kwezoqoqosho nokusebenza. I-compact solid-state console ithatha indawo encinci yomgangatho kwaye inceda ukujikeleza ngokukhawuleza kwegumbi phakathi kwamatyala otyando alandelelanayo. Iingcali zonyango zigqiba i-laser hemorrhoidoplasty kunye ne-fistula closure kwimizuzu eli-15 ukuya kwengama-20 phantsi kwe-local perianal block okanye i-light intravenous sedation.

Ukufunyanwa ngokuthe ngqo kumenzi we-TRIANGEL kususa ii-markups ze-arhente eziphakathi, kuphucula ukusebenza kakuhle kokwabiwa kwemali kumaziko otyando abucala. Eli qonga lixhasa ii-stainable optical fibers ezisemgangathweni, ii-anuscopes ezikhethekileyo ze-proctology, kunye neziqalisi ze-cannula, kudala isisombululo sotyando esipheleleyo.

I-TRIANGEL igcina izinto ezicwangcisiweyo, ibonelela ngokuhanjiswa kweenkonzo kwihlabathi liphela emnyango nomnyango kwiiveki ezimbini ukuxhasa iinkqubo zotyando ezingaphazanyiswa. Ukufikelela okuthembekileyo kwizinto ezilahlwayo ezingafunekiyo kunye nenkxaso yobunjineli ezinikeleyo kuqinisekisa ukwanda okuthe tye kweklinikhi kuwo onke amazwe ngamazwe. Izibhedlele ziphucula umthamo wethiyetha ngelixa zibonelela ngonyango lotyando olujoliswe kwisigulana.

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Utshintshiselwano loBugcisa lwe-MEDICA, iiProtocol zotyando ezibukhoma, kunye noBambiswano lweHlabathi

Ngexesha le-MEDICA, iingcali zobunjineli bezonyango ze-TRIANGEL zibambe iintlanganiso zobugcisa kunye nemiboniso ye-console esebenzisanayo yogqirha abatyandayo kunye nabasasazi. Iindwendwe zihlolisise ukusasazeka kwe-optical fiber beam, zavavanya imisebenzi yesoftware yesikrini esibonakalayo, kwaye zahlola iiprotokholi zokulinganisa amandla kuzo zonke izalathisi zeklinikhi. Iintetho zeklinikhi zibonise iziphumo zotyando lwehlabathi lokwenyani ezifunyenwe kwimisebenzi ephumeleleyo engaphezu kwe-15,000 eyenziwe kwihlabathi liphela.

Ezi ziphumo zeklinikhi zixhaswa yintsebenziswano yophando esebenzayo kwizibhedlele ezili-15 ezisebenzisana nazo kunye namaziko ophando lweklinikhi amane aseYurophu. Ngokufakelwa okungaphezulu kwe-12,000 kumazwe angaphezu kwama-80 kunye nokuxhaswa koogqirha abangaphezu kwama-300, i-TRIANGEL ibonisa ukugqwesa okuqinisekisiweyo kokwenziwa kotyando. I-TRIANGEL imema ngenkuthalo abasasazi bezixhobo zonyango bamazwe ngamazwe kunye neenethiwekhi zezibhedlele ukuba bahlole ubudlelwane bokusasazwa kwezorhwebo.

Intsebenziswano ethe ngqo kwifektri inika abasasazi iindlela zokufaka uphawu lweleyibhile yabucala, ukwenziwa ngokwezifiso kolwimi lwesiArabhu nolwesiYurophu, kunye nenkxaso yoqeqesho lobugcisa oluzinikeleyo. Iingcali zifikelela kwizixhobo zoqeqesho eziphuhliswe kuzo zonke izibonelelo zemfundo yeklinikhi ye-TRIANGEL ukuze kusekwe ubuchule botyando obuqhelekileyo.

Ukubonisana ngoBugcisa kunye namaxwebhu eFektri

Oogqirha botyando lwe-colorectal, iintloko zamasebe otyando, kunye nabasasazi bezixhobo zonyango abaya kwi-MEDICA bayamenywa ukuba baqhagamshelane neqela le-TRIANGEL. Fumana iinkcukacha zobugcisa, amaxwebhu enkqubo yeklinikhi, kunye neekowuteshini zokuthengwa kwefektri ngokuthe ngqo ngokutyelela i-portal esemthethweni ye-TRIANGEL yobunjineli bezonyango:https://www.triangelmed.com/.


Ixesha leposi: Sep-24-2026