Izindleko ze-Balloon yezindleko, Imiphumela emibi kanye neziphumo ezingenzeka
I- balloon yesisu isisindo esingenasisindo sokulahlekelwa isisindo somuntu omdala okhululekile ohluleka ukulahlekelwa isisindo ngezindlela zendabuko. Ngesikhathi esifushane, inqubo encane-invasive, i-inflatable isisindo ukulahlekelwa ibhaluni kufakwa esiswini. Ibhaluni ihlala endaweni ezinyangeni eziyisithupha ukusiza isiguli sizizwe sigcwele, sidle kancane futhi sinciphise isisindo. Iziguli zingakhetha kusuka ku- ReShape noma i- Orbera noma i-Obalon ye- balloon esiswini eye yavunyelwa i-FDA ukuze ilahlekelwe isisindo.
Kungani Uzama?
Uma unenkinga ngesisindo sakho futhi uzame ukusebenzisa izinhlelo zokudla nokuzivocavoca ngaphandle kokuphumelela, ungase ube ngumuntu omele ukhetho lokubhoboza esiswini. Idivayisi, ebizwa nangokuthi i-balloon yesisu noma isisindo sokulahlekelwa isisindo, i- FDA-evunyelwe ukulahlekelwa kwesisindo somzimba okungakusiza ukuba unciphise ngaphandle kokuya ngaphansi kommese.
"Lokhu akuyona ukuhlinzwa, kodwa usathola izinzuzo zokulahlekelwa isisindo," kusho uDkt. John Morton, oPhezulu weBariatric and Minimally Invasive Surgery eStanford University School of Medicine. "Abantu kufanele babe nokukhetha," usho kanje. UDkt. Rachel L. Moore uyavuma. UDkt. Moore ungumchwepheshe wezokwelapha ngokweqile, udokotela ohlinzayo wezinyosi kanye nomsunguli we-Moore Metabolics Bariatric Weight Loss Surgery eNew Orleans, eLouisana. "Le nqubo esingayinikeza yona ewela phakathi kwemithi kanye nenqubo yokuhlinzwa," usho kanje.
Iziguli nazo zifana nokuthi ibhaluni yesisu sinomzuzwana futhi libuyiswa.
I-balloon yesisu ihlala endaweni ezinyangeni eziyisithupha futhi ingasuswa maduzane uma uhlakulela izinkinga noma ube nemiqondo yesibili. UDkt. Morton uthi: "Abantu bangafunda amakhono okuphila abawadinga ukulahlekelwa isisindo ezinyangeni eziyisithupha ibhaluni likhona," kusho uDkt. Morton.
Kunezinhlelo ezintathu ezihlukene zesisindo sezinyosi ezitholakalayo ezigulini futhi idivayisi ngayinye iyingxenye yohlelo olubanzi oluhlanganisa nokudla, ukuzivocavoca, nokululekwa.
I-ReShape Gastric Balloon
I-ReShape Integrated Dual Balloon ingenye yamadivaysi amabili atholakalayo ezigulini ezifuna ukuzama uhlelo lokulahlekelwa kwesisindo okungelona ukuhlinzwa.
I-ReShape Dual Balloon isebenza kanjani? Lolu hlelo lwe-FDA oluvunyiwe lokulahlekelwa kwesisindo luqukethe amabhaluni amabili axhunyiwe afakwa ngaphakathi esiswini sakho. Ngenkambiso yokufaka, uhlelwe ngobumnene kokubili induduzo nokuphepha. Udokotela ufaka i-endoscope emlonyeni wakho futhi usebenzisa i-thin, i-tubular idivayisi ukubeka ngokucophelela ibhaluni ehlanjululwe ngaphakathi esiswini sakho. Uma amabhaluni esekhona, agcwele isisombululo saline (usawoti) kanye nedayi elihlaza okwesibhakabhaka. Inqubo ithatha cishe imizuzu engamashumi amabili.
Bhalisa amabhaluni ahlale endaweni ezinyangeni eziyisithupha, uthathe isikhala esiswini sakho futhi akusize uzizwe ugcwele ukuze udle kancane. Phakathi naleso sikhathi, nawe uthola ukwelulekwa ukuze uthuthukise imikhuba yakho yokudla nokuzivocavoca. Uma amabhaluni ephuka, idayi eluhlaza okwesibhakabhaka ibonisa umchamo wakho. Ngemuva kwezinyanga eziyisithupha, i-endoscope iphinda isetshenziselwe ukususa amabhaluni kusuka esiswini sakho. Ukululekwa kuyaqhubeka nezinye izinyanga eziyisithupha ngemuva kokuthi isusiwe isuswe ukukusiza ukuthi uqhubekele ekuhambeni kwakho kwesisindo, finyelela umgomo wakho wokulinganisa kanye / noma ugcine ukulahlekelwa kwesisindo .
Ubani ongathola iReShape? Leli gastric ye-balloon isisindo sokulahlekelwa kwesisindo i-FDA-evunyelwe iziguli ezine- body mass index of 30-40 kg / m2 futhi abanesimo esithinta isisindo. Isifo sikashukela, umfutho wegazi ophezulu, noma i-cholesterol ephezulu yizimo ngokuvamile ezihlobene nesisindo. Iziguli kufanele futhi zizimisele ukuzinikela ohlelweni oluphelele lokulahlekelwa isisindo oluhlanganisa nokudla, ukuzivocavoca, nokululekwa.
Ubani ongafanele athole i-ReShape? Uma ngabe uhlinzekwe nge-bariatric esikhathini esidlule, ke u-ReShape akusikho kuwe. Kunezinye izimo zezokwelashwa udokotela wakho azozihlola ukuthi lokho kungase kuqede i-ReShape njengendlela yokukhetha.
Iziguli ezinesifo sokuvuvukala kwamathumbu, ukuphuma kwamathumbu emathunjini, noma imfuyo ye-hiatal, isibonelo, akufanele isebenzise i-ReShape. Le divayisi nayo ayivunyelwe omama abakhulelwe noma abahlengikazi.
Imiphumela emibi ye-ReShape: Ngaphambi kwenkambiso udokotela wakho uzochaza ukuthi kunezingozi ezithile ezihlobene ne-sedation. Imiphumela emibi ehlotshaniswa nebhaluni ifaka isilonda, i-perforation, ubuhlungu besisu, isicanucanu, ukuhlanza, ukubhubhisa, ukugcoba, ukuguquka kwenhliziyo, ukuphela kwamanzi, nokuphuza komphimbo. Uma izimpawu ziba nzima, ibhaluni yesisu ingasuswa. Udokotela wakho wokulahlekelwa isisindo angachaza uhlu olugcwele lwemiphumela emibi kanye nezingozi ngesikhathi sokubonisana kwakho kwangaphambili.
Hlela ibhaluni imiphumela: Phakathi nesifundo somtholampilo sezinyanga ezingu-6 esihlanganisa neziguli ezingama-326, labo abasebenzisa i-Reshape balahlekelwa isisindo esiningi nedivaysi kanye nokudla okuphethwe nokuvivinya umzimba kuneziguli ezithintekayo ohlelweni lokudla nokuzivocavoca oluphethwe yedwa. Ngemuva kokuba idivayisi ibe khona izinyanga eziyisithupha, iziguli zeReShape zalahlekelwa isilinganiso sama-14.3 amakhilogremu uma kuqhathaniswa neqembu lokudla nokuzivocavoca elahlekelwa isilinganiso samapounds angu-7.2. Emva kwezinyanga eziyisithupha ezengeziwe (emva kokuthi idivayisi isusiwe izinyanga ezingu-6), iziguli ze-ReShape zazigcine ukulahlekelwa kwesisindo samapremu angu-9.9.
I-Orbera Gastric Balloon
I-Orbera Ephathwayo Yokulahlekelwa Isisindo Sesisindo seyitholakale kwamanye amazwe iminyaka eminingana, kodwa i-FDA-yavunywa e-United States ngo-2015, cishe ngesikhathi esifanayo ne-ReShape Dual Balloon System.
I-Orbera ibhaluni yesisu sinomsebenzi kanjani? Uma ukhetha i-Orbera, uzohamba nenqubo efanayo yokufaka okungenayo yokuhlinzwa (endoscopic) njenge-balloon yeReShape. Kodwa i-Orbera iyisimiso esisodwa esisodwa se-gastric balloon. Ngemuva kokuba ibhaluni elithambile, eliqinile, elithwala isisindo lifakwe, ligcwele isisombululo saline ukuze sibe ngubukhulu besithelo samagilebhisi. I-balloon yesisu ithatha cishe ingxenye eyodwa kwezintathu zesisu sakho. Idivayisi ihlala endaweni ezinyangeni eziyisithupha ngenkathi ubamba iqhaza ohlelweni oluphelele lokudla, ukuvivinya umzimba nokululekwa. Ngemuva kwezinyanga eziyisithupha, idivayisi isusiwe futhi uqhubeka nokululekwa izinyanga eziyisithupha ukuze uqhubeke nohambo lwakho lokulahlekelwa isisindo.
Ubani ongathola i- Orbera ? Lesi simiso se-balloon esisodwa i-FDA-evunyelwe iziguli ezine-body mass Index (BMI) ka-30-40 kg / m2 futhi ezame ezinye izindlela zokulahlekelwa kwesisindo ngaphandle kwempumelelo. Uma ukhetha i-Orbera, kufanele uzimisele ukuzinikela ohlelweni lokudla oluvikelwe kanye nokuvivinya umzimba ukuze uthole impilo enhle nokulahlekelwa isisindo.
Ubani ongafanele athole i-Orbera? Iziguli ezithile akufanele zisebenzise i-Orbera futhi udokotela wakho angakutshela uma ungomunye wazo . Uma ukhulelwe, uhlela ukukhulelwa zingakapheli izinyanga eziyisithupha, noma ukuncelisa ngakho akufanele uthole i-Orbera. Ukwengeza, uma uke wahlinzwa ngaphambili noma uma unezimo ezithile zezokwelapha ezihlanganisa isifo sokuvuvukala emhubheni wamathumbu, i-hernia ye-hiatal, noma isimo esiphezulu sokugaya kwamathumbu ungase ungabi yi-candidate ye-Orbera.
Imiphumela ye-Orbera . Udokotela wakho uzochaza ukuthi kunezingozi ezithile ezihambisana nesilation emincane ne-endoscopy. Izinkinga ngedivaysi ye-Orbera zingabandakanya ukuvinjelwa kwesibilini ngamabhaloni, ukukhathazeka kwesisu, ukucabangela, ukuhlanza, ubuhlungu besisu noma emuva, noma i-aclux reflux. Udokotela wakho wokulahlekelwa isisindo angachaza uhlu olugcwele lwemiphumela emibi ngesikhathi sokubonisana kwakho kwangaphambili.
I-Orbera ibhaluni imiphumela: Esifundweni sezinyanga ezingu-9 esifundazweni esibandakanya iziguli ezingu-255, iziguli ezasebenzisa i-Orbera zalahlekelwa isisindo ngaphezu kweziguli ezisebenzise uhlelo lokuguqula ukuziphatha. Ngemuva kokuthi i-Orbera ibe khona izinyanga eziyisithupha, iziguli ezinedivayisi zilahlekelwe ama-218 amakhilogremu uma kuqhathaniswa neqembu lokuguqula ukuziphatha elahlekelwa isilinganiso samakhilogremu angu-7. Ngesikhathi esilandelayo sezinyanga ezingu-9 (izinyanga ezintathu ngemuva kokuthi isusiwe sisusiwe), iziguli ezazisisebenzisa i-Orbera zagcina ukulahlekelwa kwesisindo esiphansi kwamakhilogremu angu-19. Iziguli ezazisetshenziswa ekudleni nasekuzivocavocavoca zodwa zagcina zilahlekelwa isisindo samakhilogremu angu-7.
Obalon Gastric Balloon
I-Obalon Balloon System yikhiqizwa esisha kunazo zonke ezitholakalayo iziguli. U-Obalon uyisimiso esine-balloon esamukelekayo esamukeleka i-FDA ngo-2016. I-Obalon ibhaluni yezinyosi igcwele umoya kunokuba iluhlaza.
I-Obalon ibhaluni yesisu sinomsebenzi kanjani? Iziguli ezikhetha i-Obalon zigwinya i-capsule encane ibhaluni. I-capsule ifakwe emgodini omncane osetshenziselwa ukufaka ibhaluni emoyeni. Kufika kuma-balloon amathathu angabekwa kancane kancane phakathi nezinyanga ezintathu. I-balloon ngayinye ehlongozwayo ihlala cishe cishe eyodwa indebe yevolumu esiswini futhi isilinganisane nobukhulu be-orange. Njengoba amabhaluni asekhona, iziguli zizwa zigcwele futhi azitholi kancane ekudleni ngokweqile. Zombili ngesikhathi nangemva kwesikhathi sokwelashwa, iziguli zithola ukululekwa ukuzisiza ukuba zifunde imikhuba yokudla nokuzivocavoca okunempilo. Ekupheleni kokwelashwa, amabhaluni ahlanjululwa futhi asuswe ngenqubo yokuphela.
Ubani ongathola u-Obalon ? Lesi simiso se-balloon esisodwa i-FDA-evunyelwe iziguli ezine- body mass Index (BMI) ka-30-40 kg / m2 futhi ezame ezinye izindlela zokulahlekelwa kwesisindo ngaphandle kwempumelelo. Njengamanye amahlelo we-gastric balloon, kufanele uzimisele ukuzibophezela ekudleni okunomsoco nokuvivinya umzimba ukuze uthole impilo enhle nokulahlekelwa isisindo.
Ubani ongafanele athole u-Obalon? Iziguli ezithile akufanele zisebenzise i-Orbera futhi udokotela wakho angakutshela uma ungomunye wazo . UkuPhathwa Kwezokudla Nezidakamizwa kuhlanganisa uhlu lweziguli ezingafanele zisebenzise idivayisi. Lolu hlu lubandakanya abantu abanezinkinga ezingathinta ukugwinya, labo abaye bahlinzwa ngaphambili okungenzeka baholela ekunciphiseni imithwalo yemathunjini, nalabo abaphuza imithi engase icasule umuthi wezinsi kuhlanganise ne-NSAIDS noma i-aspirin.
Imiphumela ye-Obalon. Iziguli ezikhetha u-Obalon zingase zizwe ubuhlungu besisu noma isiyaluyalu. Imiphumela emibi engavamile ihlanganisa ukuhlanza, ukushaywa indiva, ukuvinjelwa, isifo sohudo, ukucasula isisu noma ukuphuma kwegazi, ukuphuma kwegazi noma ukuqeda, ukuqotshwa noma ukulala. Udokotela wakho wokulahlekelwa isisindo angachaza uhlu olugcwele lwemiphumela emibi ngesikhathi sokubonisana kwakho kwangaphambili.
I-Obalon ibhaluni imiphumela: Ucwaningo lwezokwelapha oluhlanganisa iziguli ezingaphezu kuka-400, lwabonisa ukuthi labo abasebenzisa i-Obalon kanye nokudla nokuqeqesha ukulahlekelwa isisindo kunanoma ngubani owathola ukudla nokululekwa kokuzivocavoca wedwa. Iziguli ezathola i-Obalon Balloon System zalahlekelwa isilinganiso samaphesenti angu-14,4 noma amaphesenti angu-6.6 esisindo somzimba wabo kuyilapho iziguli ezithola ukudla nokuqeqesha ngokweqile zodwa zalahlekelwa isilinganiso samakhilogremu angu-7.4 noma amaphesenti angu-3,42 wesisindo somzimba wabo wonke.
Ingabe Kukulungele?
Ngakho wazi kanjani ukuthi iyiphi i-balloon yesisu esisodwa okufanele uyikhethe? Uma usungumtholampilo wokuthola isisindo sokulahlekelwa isisindo , ungathola ukuthi ochwepheshe abaningi be-bariatric sebekhethiwe kakade ukunikeza idivayisi eyodwa phezu komunye.
U-Obalon uyisidingo esisha sokushayela emakethe. UDkt. Shelby Sullivan, uMqondisi we-Gastroenterology Bariatric kanye nohlelo lweMetabolic e-University of Colorado School of Medicine wahileleka ekuvivinyweni kwemitholampilo ye-Obalon system. Uveza ukuthi inzuzo eyinhloko yamabhaloni agcwele umoya yisisindo somkhiqizo. Uthi idivaysi yesisindo esilula iholela ezinganeni ezincane futhi zihlukumeze iziguli. Ekukhululweni wachaza ukuthi iziguli ngokuvamile zidinga isikhathi esincane sokuphumula ngemuva kokubekwa ibhaluni sinezela ukuthi lokhu "kuhluke kwamanye amadivaysi e-intragastric balloon avunyelwe njengamanje, lapho iziguli eziningi azikwazi ukubuyela khona emisebenzini evamile ngokushesha."
UDkt. Moore, onika iziguli zakhe i-Orbera ibhaluni esiswini, uthi wakhetha uhlelo olulodwa lwe-balloon ngoba linomlando wokuphepha nokusebenza kwamanye amazwe. Uveza ukuthi nakuba idivayisi entsha eNew States, isetshenziswe kakhulu futhi ithandwa kakhulu kwamanye amazwe kuhlanganise neBrazil, i-Italy neSpain.
UDkt. Morton unikeza iziguli zakhe iReShape. Uthi usebenzisa i-ReShape ngoba uma usebenzisa amabhaluni amabili ungagwema izinkinga ezingase zenzeke uma ibhaluni elilodwa lingcolisa. Futhi ngenxa yokuthi u-Reshape ukhulu kakhulu futhi uhlala esesiswini, uthi uthi uye waphawula ukunyakaza okungenani kwe-balloon kanye nesisindo esincane ezigulini zakhe.
UDkt. Trace Curry unikeza bobabili u-Obera noReShape esikhungweni sakhe sokulahlekelwa isisindo. UDkt. Curry ungumhlinzeki ohlinzekwa yibhodi oqinisekisiwe ebhodini nomqondisi wezokwelapha weMetabolic Weight Loss Centers eCincinnati, Ohio. Wayenguye ohlinzayo wokuqala e-Ohio ukuhlinzeka ngama-balbons we-Orbera neReShape esiswini. Uthi lapho iziguli zakhe zimbuza ukuthi ibhaluni lizolikhetha ubatshela ukuthi imiphumela yabo iyoxhomeka kakhulu emizamweni yabo kunokuba yilokho abakhethayo.
"Ukuvuselela kubiza kakhulu," usho kanje. Kodwa uye wathola emcimbini wakhe ukuthi kunezinkinga ezimbalwa ezihambisana ne-balloon system. Uthi, "Kodwa i-Orbera," ibonise ukulahlekelwa kwesisindo esincane kangcono ekuvivinyweni kokwelashwa. "
Uyanezela ukuthi kokubili amabhaluni enesisu anganikeza inzuzo. Futhi uDkt. Morton uyavuma. "" Noma yikuphi ukungenelela kungcono kunazo zonke, "kusho uDkt. Morton. Kodwa udokotela ngamunye uqinisekisa ukuthi ibhaluni ayiyona isisombululo somlingo sokulahlekelwa isisindo. Uma ufuna ukulahlekelwa isisindo nebhaloti, kufanele uzimisele ukuzinikela ekuguqulweni kwesikhathi eside sokuphila.
Izindleko ze-Gastric Balloon
Intengo ye-balloon yakho yesisu iyohlukahluka kuye ngokuthi indawo yakho, udokotela wakho nakudivayisi oyisebenzisayo. Izindleko zesikhumba esiswini sonke singabuka ku-$ 6,500 - $ 10,000. Imitholampilo eminingi inikeza inkonzo nge $ 7,500.
Izindleko eziphelele zesistimu ye-gastric balloon kufanele ifake idivaysi, ukufaka, ukususwa, ukwelulekwa ngesikhathi sesibhaloni sezinyanga eziyisithupha kanye nokululekwa kwezinyanga eziyisithupha emva kokususwa.
I-balloon yezinyosi okwamanje ayihlanganiswa nomshuwalense e-United States, kodwa bonke odokotela abaxoxwa nabo bathi bathemba ukuthi ekugcineni kuzobe sekuhlinzekwa. Phakathi naleso sikhathi, iziguli zingasebenzisa i-akhawunti yokulondoloza impilo noma izinsizakalo zokuboleka ezempilo (ukubolekwa kwemali) ukumboza izindleko zenqubo.
Khumbula ukuthi kufanele uthathe okungaphezu kwezindleko uma ucabanga ibhaluni yesisu kanye nodokotela ukufaka idivayisi. Ochwepheshe batusa ukuthi kufanele ngaso sonke isikhathi ubheke udokotela oqinisekisiwe ophethe isipiliyoni efaka idivayisi. Uma udokotela wakho engxenyeni yesisindo esikhulu sokulahlekelwa kwesisindo, uzokwazi ukuthola ukululekwa ubuso nobuso okungakusiza ukukugcina endleleni. Futhi-ke, njengoba ukuphepha kuhlale kubalulekile, bheka indawo eqinisekisiwe ngokusebenzisa i-ejensi kazwelonke efana ne-Accreditation Association ye-Ambulatory Health Care (AAAHC) noma i-American Association Yokugunyazwa Kokuhlinzekwa Kwama-ambulatory Surgery Facilities (AAAASF).
Imithombo:
Amadivaysi Ezokwelapha. Ukuphathwa kwe-US nokuDrug. I-ReShape Integrated Dual Balloon System - P140012 Kufinyelelwe: April 6, 2016. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm456293.htm
Amadivaysi Ezokwelapha. Ukuphathwa kwe-US nokuDrug. Uhlelo lwe-ORBERA ™ lwe-Balticon System - P140008 Kufinyelelwe: April 6, 2016. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm457416.htm
I-Orbera. I-Apollo Endosurgery. Kufinyelelwe: ngo-Ephreli 6, 2016. https://www.orbera.com/
Buyisela kabusha. I-ReShape Medical. Kufinyelelwe: ngo-Ephreli 6, 2016. https://reshapeready.com/