NO329670B1 - Frigivelsesbart-festbart justerbart mageband i ett stykke - Google Patents
Frigivelsesbart-festbart justerbart mageband i ett stykke Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/005—Gastric bands
- A61F5/0053—Gastric bands remotely adjustable
- A61F5/0056—Gastric bands remotely adjustable using injection ports
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/1322—Tourniquets comprising a flexible encircling member
- A61B17/1327—Tensioning clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/135—Tourniquets inflatable
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Abstract
Et frigivelsesbart-festbart magebånd med en haleende (10a) og en hodeende (10b) for å motta haleenden er vist. Magebåndet inkluderer også en frigivelsesbar låseanordning som frigivelsesbart fester hodeenden og haleenden sammen. Haleenden kan inkludere en tann (14) og hodeenden kan inkludere en innskjæring (22) for å bringes til inngrep med tannen (14). Etter innføring av haleenden inn i hodeenden vil tannen være i sammenpassende inngrep med innskjæringen og vil frigivelsesbart låse haleenden i hodeenden. Det frigivelsesbare-festbare magebånd inkluderer også en frigivelsesflik (24). Når kraft utøves på frigivelsesfliken i en retning perpendikulær til en sentral akse av magebåndet vil tannen (14) frigis fra innskjæringen (22) for å tillate at magebåndet frigis.
Description
BAKGRUNN FOR OPPFINNELSEN
1. Oppfinnelsesområdet
Den foreliggende oppfinnelse vedrører generelt kirurgisk implanterte magebånd for å omgi magen og som har et frigivelsesbart- festbart appendiks. En fremgangsmåte for behandling av sykelig fedme og som anvender en slik frigivelsesbar-festbar magebåndinnretning er også beskrevet.
2. Beskrivelse av beslektet teknikk
Et båndlignende magebånd for å omgi magen for å kontrollere sykelig fedme er vist i US patent 5.601.604 (Vincent), innlemmet heri som referanse. Magebåndet omfatter et belte som kan føres omkring magen og låses i en omgivende posisjon for å skape en stomaåpning inne i magen. En regulerbar del av båndet omfatter et ekspanderbart element som tillater fin regulering av stomaåpningen etter at nevnte sto-rma er skapt ved å låse båndet på plass. Stomaåpningen kan reguleres ved å tilføre eller trekke ut et fluid inn i eller ut fra det ekspanderbare element. Anordningen for å injisere fluidet inn i det ekspanderbare element omfatter vanligvis en fylleport lokali-sert under huden og som vil være ekstrakorporealt tilgjengelig ved transdermal injek-sjon. Etter implantering kan således magebåndet reguleres til å forstørre eller for-minske stoma etter behov.
Magebåndet implanteres kirurgisk, via laparoskopy eller laparotomy og kan innebære anbringelse av et kalibreringsapparat i magen for å posisjonere nevnte stoma og størrelsen av den lomme som skapes oppstrøms fra stoma. Magebåndet anbringes i overlappende forbandposisjon omkring magen for å hindre forskyvning, vanligvis ved hjelp av gastro-gastriske suturer (d.v.s. at vrenges over båndet og sutu-reres til seg selv.
Som vist i det nevnte US patent (Vincent) er det ekspanderbare element eller kapslingen foretrukket i det vesentlige ko-ekstensivt med den indre overflate av magebåndet vendt mot mageoverflaten. Det er videre blitt iakttatt at det ekspanderbare element ikke skal krølle seg eller foldes når det reguleres, slik at det frembyr en hovedsakelig glatt kontur langs den indre omkrets. For å sikre at magevevet ikke bare blir klemt av det inflaterbare element, som kunne føre til ubehag eller nekrose, men at også kapslingen beskyttes mot et fenomen kjent som krølle-foldesvikt, som kan skje hvis kapslingen ekspanderes utover sitt tilsiktede reguleringsområde eller hvis kapslingen ikke tildannes i en toroidal eller sirkulær form.
I bruk er det blitt iakttatt at nåværende magebånd ikke lett kan frigis så snart de er låst på plass omkring magen for å danne stoma. Dette kan være en signifikant ulempe for en kirurg som prøver å bevege et magebånd etter implantasjon. Spesielt kan en pasients fysiologi eller endring i fysiologi nødvendiggjøre at båndet flyttes etter initial anbringelse. Andre faktorer som kunne nødvendiggjøre at båndet beveges eller frigis inkluderer en pasients manglende evne til å kontrollere matinntak.
I tilfeller hvor båndet har glidd ut av stilling, er uriktig anbrakt, eller hvor end-ringer i pasientfysiologien krever bevegelse av båndet, vil de nåværende kjente magebånd ikke tilveiebringe frigivelse av låseanordningene som holder båndet sikkert omkring en pasients mage. Mens noen innretninger riktig nok kan være frigivelsesbare vil disse innretninger typisk kreve utøvelse av betraktelig kraft som kan bevirke skade på eller ødeleggelse av båndet. Når båndet manipuleres laparoskopisk vil videre den kraft som kan utøves under en slik prosedyre være meget begrenset.
En magebåndinnretning som viser seg å ha noen evne til å bli låst og åpnet markedsføres under betegnelsen "HELIOGAST®". "Heliogast" båndet er et ekspanderbart magebånd som har ekspanderbare låseanordninger festet til haleenden av båndet og som innføres i en sløyfe festet til hodeenden av båndet. Etter implantasjon må båndet ekspanderes for å låse båndet på plass. I teorien kunne dette bånd gjen-åpnes etter anbringelse for å tillate at en medisinsk fagkyndig reposisjonerer båndet. Båndet lider imidlertid av den ulempe at det må ekspanderes for å låses i posisjon og det må derfor trykkavlastes før det åpnes og fjernes. Det krav at båndet må ekspanderes for å låses fast begrenser også det område av stomaåpning som kan oppnås ved hjelp av et slikt bånd, etter som båndet må nødvendigvis ha et visst grad av væs-ketrykk inne i båndet for å låses fast. Følgelig er reguleringsområdet av "heliogast" båndet begrenset i sammenligning med båndet ifølge den foreliggende oppfinnelse, som kan låses uansett sitt ekspansjonsområde. I tillegg kan båndet åpnes ved ut-øvelse av en mindre kraft enn de tidligere kjente bånd. Muligheten av mindre krattan-vendelse for å overvinne låsemekanismen øker muligheten for at båndet åpnes tilfel-dig, som for eksempel hvis pasienten skulle kaste opp.
Det foreligger derfor et behov for et frigivelsesbart magebånd som frigivelsesbart kan låses på plass omkring en pasients mage, frigis eller åpnes for å reposisjo-nere magebåndet på pasientens mage (eller å fjerne hele båndet), og deretter på nytt festes på plass omkring pasientens mage. Det foreligger et ytterligere behov for et frigivelsesbart-festbart magebånd som ikke krever trykkavlastning før det frigis, og som kan låses på plass uten etterfølgende ekspansjon av låseanordningen. Det foreligger i tillegg et behov for et magebånd som motstår at det åpnes av normale fysio-logiske krefter.
Det foreligger også et behov for et regulerbart magebånd med økt bruksbe-kvemmelighet når det sammenlignes med de bånd som er tilgjengelige på det inter-nasjonale marked, spesifikt et magebånd som har høy strekkraftmotstand langs båndet, mens det kan åpnes med redusert kraft.
Forskjellige andre formål, fordeler og trekk ved den foreliggende oppfinnelse vil lett sees fra den følgende beskrivelse og de nye trekk vil bli spesielt påpekt i de senere anførte patentkrav.
OPPSUMMERING AV OPPFINNELSEN
Målene med den foreliggende oppfinnelse oppnås ved et frigivelsesbart-festbart regulerbart magebånd, omfattende: en halende; en hodeende for å motta den nevnte haleende; og en frigivelsesbar låseanordning for frigivelsesbart å feste nevnte hode-ende og haleende av magebåndet i en innsirklende posisjon, kjennetegnet ved at det ytterligere omfatter en skråtann tildannet på en del av haleenden, en innvendig innskjæring i hodeenden for å bringes i inngrep med skråtannen, at etter innføring av haleenden inn i hodeenden går skråtannen til inngrep med den nevnte innvendige innskjæring og låser frigivelsesbart haleenden i hodeenden, at det ytterligere omfatter en frigivelsesflik på hodeenden, at utøvelse av kraft på frigivelsesfliken i en retning hovedsakelig perpendikulær til en sentral akse av magebåndet tillater at skråtannen frigis fra den nevnte innvendige innskjæring, slik at haleenden kan frigis fra hodeenden.
Foretrukne utførelsesformer av magebåndet er videre utdypet i kravene 2 til og med 7.
For en bedre forståelse av oppfinnelsen, dens operative fordeler og spesifikke formål som oppnås ved dens bruk, vises det til de vedføyde tegninger hvori foretrukne utførelsesformer av oppfinnelsen er illustrert.
KORT BESKRIVELSE AV TEGNINGENE
Fig. 1 er et sideriss av en haleende av et magebånd ifølge den foreliggende oppfinnelse; Fig. 2 er et sideriss av en hodeende av et magebånd ifølge den foreliggende oppfinnelse; Fig. 3 avbilder et magebånd ifølge den foreliggende oppfinnelse med et glatt ekspanderbart element; Fig. 4 viser et tretthetsmotstandsdyktig ekspanderbart element av et magebånd; Fig. 5 avbilder et tidligere kjent magebånd ifølge US patent 5.601.604 (Vincent); Fig. 6 er et perspektivriss av et magebånd ifølge den foreliggende oppfinnelse og viser hodeenden av båndet i forgrunnen; og Fig. 7 er et perspektivriss av et magebånd ifølge den foreliggende oppfinnelse og som viser haleenden i forgrunnen.
DETALJERT BESKRIVELSE
Den foreliggende oppfinnelse er rettet på et laparoskopisk implanterbart regulerbart magebånd konstruert til å bli åpnet eller frigitt laparoskopisk for å lette reposisjonering eller uttak etter behov. Så snart det er låst i posisjon kan tidligere kjente laparoskopiske magebånd, som for eksempel "LAP-BAND®" båndet bare åpnes med vanskelighet og med fare for å skade komponentene på grunn av den kraft som kreves. Mens det er spesielt egnet for laparoskopisk implantasjon, frigivelse og/eller uttak, er magebåndet ifølge den foreliggende oppfinnelse også egnet for standard laparotomiprosedyrer.
Med henvisning til fig. 1 og 7, vises der en haleende 10a av et frigivelsesbart-festbart magebånd 12.1 fig. 2 og 6 er hodeenden 10b av magebåndet 12 vist. Haleenden 10a omfatteren langstrakt spiss 18, som kan innlemme et ekspansjonsrør 30, og en skråtann 14. Ekspansjonsrøret 30 har et lumen derigjennom for å tillate at fluid kan tilføres eller tas ut fra den ekspanderbare del av båndet 32 for hydraulisk å regulere diameteren av båndet når dette er i en omgivende posisjon omkring magen eller et ønsket organ. Som det er vel kjent innen dette område kan en stoma av ønsket størrelse skapes ved å regulere diameteren av magebåndet. Reguleringen kan gjennomføres hydraulisk eller mekanisk. I et hydraulisk regulerbart magebånd behø-ver ekspansjonsrør 30 ikke å være innlemmet i haleenden 10a. I stedet kan det være innlemmet ved hodeenden 10b eller ved et hvilket som helst punkt derimellom. Alter-nativt kan magebåndet 12 reguleres ved hjelp av en rekke forskjellige kjente meka-niske anordninger. Uansett om det er hydraulisk eller mekanisk blir magebåndet 12 foretrukket reguleres via fjernstyring fra utsiden av kroppen. Slike fjernstyrte innsnev-ringsinnretninger kan være aktive innretninger, d.v.s. at de drives av implanterbare energikilder som for eksempel batterier, kondensatorer, etc. eller passive innretninger som drives fra utsiden av kroppen ved hjelp av energi overført gjennom radiofre-kvens, induksjon, elektromagnetisk energi, etc.
Med henvisning til de frigivelsesbare låsetrekk ifølge den foreliggende oppfinnelse er tannen 14 definert på en side av en utsparing 16, og kan inkludere en visuell indikator 38, som skal drøftes senere i forbindelse med hodeenden 10b. Også vist i
fig. 1 er den regulerbare del av båndet 32. Tildannet på hodeenden 10 av magebåndet 12 er et gripeland 34, som tillater at kirurgen eller annen medisinsk fagkyndig kan gripe magebåndet 12 uten fare for å skade de fluidholdige deler av båndet. Gripelandet 34 er spesielt til hjelp når et tidligere låst magebånd frigis.
Hodeenden 10b, som vist i fig. 2, inkluderer en spenne 20, som mottar og låser haleenden 10a for å anbringe båndet i en omgivende posisjon omkring magen. Spennen 20 inkluderer en innskjæring 22 for å motta skråtannen 14 på haleenden 10a. Hodeenden 10b omfatter videre en frigivelsesflik 24. Et ytterligere trekk ved hodeenden 10b er indikatorvinduet 36, som tillater at kirurgen eller annen medisinsk fagkyndig person å betrakte indikatordelen 38 av haleenden 10a, foretrukket uthevet ved en kontrastfarge eller en tekstur, når den er innført i hodeenden 10b for å tilveiebringe positiv visuell og/eller berøringsindikasjon om at magebåndet er blitt frigivelsesbart låst i posisjon.
I praksis implanteres magebåndet omkring pasientens mage ved bruk av nå-standard laparoskopisk eller laparotomiske prosedyrer, velkjent for de fagkyndige innenfor området av gastrisk båndomslyngningsteknikk. Så snart magebåndet 12 omgir magen og er posisjonert i den ønskede lokalitet langs lengden av magen innfø-res haleenden 10a i spennen 20 på hodeenden 10b. Et lukkeverktøy, som for eksempel det som er beskrevet i US patent nr 5.658.298 (Vincent og Coe), hvis beskrivelse er beskrevet heri som referanse, kan anvendes for å feste sammen haleenden og hodeenden, henholdsvis 10a og 10b. For eksempel trekkes haleenden 10a gjennom spennen 20 inntil skråtannen 14 og innskjæringen 22 kommer i inngrep med hverandre eller låses sammen og hindrer at magebåndet 12 kan åpne seg. Når de to ender av magebåndet er riktig sammenlåst er indikatoren 38 på haleenden 10a synlig gjennom vinduet 36 på hodeenden 10b.
Ytterligere elementer av magebåndet 12 er sammenpassende fordypninger 26 og 28 på henholdsvis haleenden og hodeenden henholdsvis 10a og 10b. Disse fordypninger, som hovedsakelig er det negative bilde av hverandre, butter sammen og hindrer overlapping av de to ender av den indre overflate 32 av magebåndet som vender mot magen når båndet er i sin lukkede posisjon. Fordypningene 26 og 28 er tildannet på henholdsvis hodeenden og haleenden for å sikre at en hovedsakelig glatt kontinuerlig overflate kommer i kontakt med pasientens mage.
Det frigivelsesbare-festbare magebånd ifølge den foreliggende oppfinnelse krever en totrinns prosedyre for å frigjøre sin sammenlåsende hodeende og haleende. Først frigis den forriglende tann 14 og innskjæringen 22 ved å trekke frigivelsesfliken 24 i en retning hovedsakelig perpendikulær til en sentral akse av det enda lukkede magebånd 12. For å hjelpe til med å trekke i frigivelsesfliken 24 kan kirurgen eller annen medisinsk fagkyndig også gripe gripelandet 34 med et andre medisinsk in-strument. Ved å gjøre dette hjelper det til med å holde magebåndet 12 på plass, slik at kraft kan utøves effektivt på frigivelsesfliken 24. Deretter kan haleenden 10a fjernes fra hodeenden 10b hvis båndet skal fjernes eller løsnes tilstrekkelig til å tillate at magebåndet 12 kan reposisjoneres langs lengden av pasientens mage.
Ved anvendelsen av en litt forlenget hodeende 10b, i sammenligning med det tidligere nevnte "LAP-BAND"® og US patent 5.601.604 bevirker strekk på frigivelsesfliken 24 en translasjonskraft mot den sentrale akse av magebåndet 12, slik at hodeenden og haleenden av magebåndet 12 ifølge den foreliggende oppfinnelse åpnes og frigis for å tillate reposisjonering eller fjernelse av magebåndet 12 uten fare for å skade magebåndet. Både sammenpasningen av tannen 14 og innskjæringen 22, og elastisiteten av de materialer hvorav magebåndet er fremstilt kan optimeres for å sikre tilstrekkelig sikker lukking av magebåndet som krever forholdsvis liten kraft på frigivelsesfliken 24 for å åpne seg.
Selvfølgelig kan andre geometrier enn skråtannen 14 og innskjæringen 22 anvendes for å oppnå evnen til løsbar sikring av båndet i samsvar med den foreliggende oppfinnelse. En slik geometri inkluderer flere mindre forriglende elementer. Videre kunne låseelementene være formet for en "sneppert-pasning" for å tilveiebringe taktil indikasjon om at båndet er festet på plass eller hvis større motstand mot frigivelse er ønskelig.
Den foreliggende oppfinnelse kan anvendes i forbindelse med et hovedsakelig glatt regulerbart element 32, som vist i fig. 3, og som kjent på dette område. Alterna-tivt kan den foreliggende oppfinnelse anvendes i forbindelse med et nyere tretthetsmotstandsdyktig ekspanderbart element 32a, som vist i fig. 4. Et tretthetsmotstandsdyktig bånd beskrevet i detalj i PCT/US03/26678 og er innlemmet heri som referanse. Som beskrevet deri er den tretthetsmotstandsdyktige ekspanderbare del 32a forsynt med flere kammere og er motstandsdyktig mot krølling eller folding over sitt reguleringsområde. I likhet med den regulerbare del 32 vist i fig. 3, frembyr den tretthetsmotstandsdyktige ekspanderbare del 32a en hovedsakelig glatt kontur langs den indre omkrets for å fremme bærerens velbefinnende og unngå klemming av magen som kan føre til nekrose. Det tretthetsmotstandsdyktige ekspanderbare element er vist i tverrsnitt i fig. 4 separat fra et fullstendig magebånd for bedre å illustrere dets nye trekk. Som med tidligere kjente bånd kan et magebånd omfattende en tretthetsmotstandsdyktig ekspanderbar del 32a forhåndsdannes i en sirkel, kan låses på plass av kirurgen eller en medisinsk sakkyndig, og kan i en foretrukket utførelsesform ekspanderes via et inflasjonslumen som forløper gjennom haleenden 10a av magebåndet.
Magebånd ifølge den foreliggende oppfinnelse kan oppbygges i sekvensmes-sige støpetrinn og resultere i en fullstendig automatisert sammenstilling og en høy nøyaktighetsgrad. Videre kan de materialer hvorav magebåndet kan fremstilles inkludere silikon og andre materialer kjent for de fagkyndige som forlikelige for implantasjon i kroppen.
Det sees således at de formål som er angitt i foregående, blant annet tydelig-gjort fra den foreliggende beskrivelse, oppnås effektivt og på grunn av at visse end-ringer kan foretas ved å gjennomføre den foreliggende fremgangsmåte og i den eller de anførte konstruksjoner uten å gå utenfor ideen og rammen for oppfinnelsen, er det ment at alle detaljer inneholdt i den foregående beskrivelse og vist i de vedføyde tegninger skal fortolkes som illustrerende og ikke i en begrensende mening.
Claims (7)
1. Frigivelsesbart-festbart regulerbart magebånd (12), omfattende: en halende (10a); en hodeende (10b) for å motta den nevnte haleende (10a); og en frigivelsesbar låseanordning for frigivelsesbart å feste nevnte hode-ende (10b) og haleende (10a) av magebåndet (12) i en innsirklende posisjon, karakterisert ved at det ytterligere omfatter en skråtann (14) tildannet på en del av haleenden (10a), en innvendig innskjæring (22) i hodeenden (10b) for å bringes i inngrep med skråtannen (14),
at etter innføring av haleenden (10a) inn i hodeenden (10b) går skråtannen (14) til inngrep med den nevnte innvendige innskjæring (22) og låser frigivelsesbart haleenden (10a) i hodeenden (10b), at det ytterligere omfatter en frigivelsesflik (24) på hodeenden (10b), at utøvelse av kraft på frigivelsesfliken (24) i en retning hovedsakelig perpendikulær til en sentral akse av magebåndet (12) tillater at skråtannen (14) frigis fra den nevnte innvendige innskjæring (22), slik at haleenden (10a) kan frigis fra hodeenden (10b).
2. Frigivelsesbart-festbart magebånd ifølge krav 1,
karakterisert ved at det ytterligere omfatter en visuell fastsettingsindi-kator (38).
3. Frigivelsesbart-festbart magebånd ifølge krav 2,
karakterisert ved at det ytterligere omfatter et vindu (36) for å tilveiebringe positiv visuell indikasjon når hodeenden (10b) og haleenden (10a) er frigivelsesbart festet sammen.
4. Frigivelsesbart-festbart magebånd ifølge krav 3,
karakterisert ved at magebåndet (12) frigivelsesbart er låst på plass når den nevnte indikator (38) blir synlig i vinduet (36) etter innføring av haleenden (10a) inn i hodeenden (10b).
5. Frigivelsesbart-festbart magebånd ifølge krav 1,
karakterisert ved at det ytterligere omfatter en taktil fastsettelsesindi-kator.
6. Frigivelsesbart-festbart magebånd ifølge krav 1,
karakterisert ved at båndet (12) er regulerbart via hydraulisk ekspansjon.
7. Frigivelsesbart-festbart magebånd ifølge krav 6,
karakterisert ved at haleenden omfatter et inflasjonsrør.
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PCT/US2005/001620 WO2005072195A2 (en) | 2004-01-23 | 2005-01-21 | Releasably-securable one-piece adjustable gastric band |
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