DK200800058U1 - Anordning og fremgangsmåde til implantation af en endoprotese - Google Patents
Anordning og fremgangsmåde til implantation af en endoprotese Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
Description
i DK 2008 00058 U3
ANORDNING TIL IMPLANTATION AF EN ENDOPROTESE
BESKRIVELSE
TEKNISK OMRÅDE
Den foreliggende opfindelse angår en anordning til implantation af et implantat.
5 Problemet, der ligger til grund for opfindelsen, angår implantation af hjerteventiler. Dette krævede indtil for nylig et kirurgisk indgreb med åbent hjerte med trin, såsom standsning af hjertet, iværksættelse af ekstrakorporal blodcirkulation og genstart af hjertet efter implantation af erstatningshjerteventilerne. Disse kirurgiske indgreb er vanskelige og følsomme og frembyder 10 dødelige risici i forbindelse med operationschok.
KENDT TEKNIK
I dokumentet US patent nr. 5 824 063 beskrives således en anordning, der bærer erstatningshjerteventiler, hvilken anordning omfatter et rørformet implantat af et syntetisk materiale, der indvendigt bærer en erstatningsventil af 15 et naturligt materiale.
I dokumenterne US patent nr. 5 855 601 og US patent nr. 5 868 783 beskrives nye implantationsmetoder til hjerteventiler, der frembyder den fordel, at kirurgiske indgreb med åbent hjerte undgås. Disse fremgangsmåder tilvejebringer implantation ved fremføring gennem blodcirkulationssystemet af 20 en erstatningshjerteventilanordning omfattende en radialt ekspanderbar intravaskulær cylinder, der indvendigt bærer en biologisk ventil. En oppustelig del af et ballonkateter anbringes inde i den bærende cylinder, og implantationen udføres ved introduktion i en vene og fremføring til den svigtende ventil ved anvendelse af et kateter. En todimensional billedskærmvisning gør det muligt at 25 detektere, om den bærende cylinder har nået den ønskede position, og cylinderen udspiles derefter ved oppustning af ballonen gennem kateteret og fastholder dens udvidede form. Derefter slippes luften ud af ballonen, og denne 2 DK 2008 00058 U3 fjernes sammen med kateteret. Den bærende cylinder har en tæt kappe, der saledes placeres mod arterievæggen for således at undgå, at blodstrømmen passerer uden om erstatningsventilen.
Nar der er tale om aorta, er denne fremgangsmåde imidlertid ikke anvendelig, fordi kransarterierne udmunder tæt på de svigtende native ventiler, således at den bærende cylinder sandsynligvis vil blokere dem og derved forårsage patientens død.
FORMÅLET MED OPFINDELSEN
Opfinderne af den foreliggende ansøgning har derfor tænkt på at tilvejebringe to tilsvarende åbninger i væggen af den bærende cylinders kappe. For at disse åbninger vil blive placeret over for de to kransarterier, skal den bærende cylinders position i aorta imidlertid være fuldt kontrolleret. Overvågning på skærmen gør det muligt at kontrollere fremføringen, eller den aksiale position, af den bærende cylinder, men den vinkelmæssige position hverken vil være synlig eller kontrolleret.
Ansøgerne har derfor fundet en løsning, der er beskrevet nedenfor, og som muliggør kontrol af den bærende cylinders position.
De har derfor overvejet løsningen af det mere generelle problem med placering af en implantatanordning eller transportmiddel i et rørformet element med vanskelig adgang, og for hvilke billeddannelse er utilstrækkelig eller endog umulig. Anvendelsesområdet kan som følge heraf angå andre områder end det medicinske, såsom olieindustrien eller den nukleare industri, med henblik på installation af sensorer, ventiler, etc. Den foreliggende opfindelses rækkevidde skal derfor ikke betragtes som afgrænset til løsningen af det oprindelige problem. Opfindelsen tager mere generelt sigte på at muliggøre placering på et vanskeligt tilgængeligt sted af et rørformet element af en anordning, der er beregnet til at bære et implantat, uanset implantatets funktion.
SAMMENDRAG AF OPFINDELSEN
3 DK 2008 00058 U3
Til dette formål angår opfindelsen først og fremmest en anordning til implantation i en bestemt position af et rørformet element med en væg omfattende et hulrum, hvilken anordning er indrettet til at samarbejde med midler til at fremføre anordningen i det rørformede element, en anordning, der er kendetegnet ved, at den omfatter følere, der er deformerbare og indrettet således, at den, under kontrol af fjernstyringsmidler, skifter fra en sammenfoldet til en udfoldet funktionel form, for at detektere hulrummet og placere sig selv der med reference til hulrummets position.
Det er således muligt at fremføre anordningen i blinde, og følerne gør det muligt automatisk at detektere hulrummet og anbringe sig i dette.
Det er således muligt at få adgang til den endelige krævede position, endog gennem en indsnævring af det rørformede element, for eksempel en adgangsartene, der fører til en arterie med en større diameter.
KORT BESKRIVELSE AF TEGNINGERNE
Den foreliggende opfindelses karakteristika og fordele vil fremgå tydeligere ved hjælp af den følgende beskrivelse afen særlig udførelsesform for anordningen ifølge opfindelsen og en variant med reference til den vedføjede tegning, hvorpå: - figur 1 er et tværsnit fra siden af anordningen ifølge opfindelsen, der viser placerings- og forankringselementerne, forbundet med en cylinder bærende en ventilprotese, hvor det hele er dækket at to aftagelige koncentriske aktiveringshylstre, - figur 2 svarer til figur 1, hvor følerplacerings- og forankringselementerne er udfoldet radialt ved aksial tilbagetrækning af det eksterne hylster, - figur 3 svarer til figur 1 og 2, med den bærende cylinder omgivet af placerings-og forankringsfølerelementer, der er udfoldet radialt efter aksial tilbagetrækning af det interne hylster, 4 DK 2008 00058 U3 - figur 4 er en illustration fra siden af den bærende cylinder og placerings- og forankringsfølerelementerne, - figur 5 er en illustration i perspektiv fra siden af placerings- og forankringsfølerelementerne, - figur 6 er en skematisk visning forfra af anordningen ifølge opfindelsen, og - figur 7 er et skematisk tværsnit fra siden af varianten.
DETALJERET BESKRIVELSE
Som vist i figur 1, svarer det foreliggende udførelseseksempel til det medicinske problem, der er forklaret i starten, med implantation af en fungerende erstatningsventil for den native aortaventil. Anordningen 10 til implantation af ventiler omfatter et bærende element 20 til modtagelse af implantatet, der står i forbindelse med et antal følerelementer eller fingerelementer 30, 31, der her er regelmæssigt fordelt vinkelmæssigt hele vejen rundt, til placering og forankring i forhold til et relief, specifikt et hulrum i aortavæggen, hvilken anordning 10 er aftageligt forbundet til et placeringskateter 60. Anordningen 10 er forbundet med to koncentriske hylstre 41, 42 for successiv fjernstyring ved radial ekspansion af følerelementerne 30, 31 derefter bæreelementet 20. Fremføringsretningen for anordningen 10 er derfor mod venstre på figur 1 til 3. Reference 62 repræsenterer en symmetriakse og fremføringsretning for anordningen 10 og et kateter 60.
Implantationsventilen danner en protese 1 omfattende ventilklapper 2, hvis form og størrelse i driftspositionen perfekt svarer til de native aortaventiler 50 (figur 2). Protesen 1 fastgøres til det bærende fremføringselement 20 til modtagelse af implantatet, her bestående af et cylindrisk trådnet af et biologisk kompatibelt materiale såsom stål, guldlegeringer og fortrinsvis som her nitinol, der består af en nikkel-titanlegering med formhukommelse, som har mulighed for at genfinde sin form efter den første deformering, her ved radial kompression. Fastgørelsen af protese 1 til det cylindriske nitinoltrådnet 20 sker på veldefinerede 5 DK 2008 00058 U3 placeringer, hvorved de regioner, der svarer til ventilklapperne 2 efter udfoldelse fra den sammenfoldede position fra figur 2, som illustreret nedenfor med hensyn til figur 3, holdes frie.
Figur 4 viser det cylindriske trådnet 20 i den udfoldede form, bærende ventilklapperne 2 ligeledes indvendigt udfoldet, hvorpå følerelementerne 30, 31 er fastgjort, her i form af en generelt cylindrisk udvendig ring af trådsløjfer, hvoraf mindst én (31), her reelt tre, stikker frem lateralt og fremefter, modsat kateteret 60. I dette eksempel strækker sløjferne 31, i den udfoldede position, sig i en retning, der hælder ca, 30 grader fremefter (fremføringsretning mod målpositionen) i forhold til aksen 62 af trådnettet 20 og ringen 30. Følerelementerne 30, 31 er forbundet med det cylindriske trådnet 20 på en sådan måde, at deres aksiale og vinkelpositioner i forhold til det er perfekt definerede. Enheden, cylindrisk trådnet 20 og følerelementer 30, 31, består her af det ovennævnte automatisk ekspanderbare biologisk forenelige materiale.
Det cylindriske bærende trådnet 20 er her dækket af en uigennemtrængelig kappe 21, der er beregnet til at blive presset mod aortavæggen for at undgå, at blodcirkulationen passerer udenom.
Figur 5 viser følerelementerne 30, 31 i perspektiv. Figur 6 er en skematisk illustration langs en akslal retning af anordningen 10, der viser de tre sløjfer 31, der stikker frem lateralt fra det rørformede gitterværk 20, der bærer dem, mens ventilklapperne 2 af ventilen, der skal implanteres, fastgøres indvendigt til den bærende cylinder 20.
Der kan endvidere, hvis det er nødvendigt, placeres en oppustelig ballon 3, i fast forbindelse med kateteret 60, inde i den bærende cylinder 20, til opfyldning med væske under tryk gennem kateterrør 60 for således at bevirke eller bidrage til den radiale ekspansion af den bærende cylinder 20 til den ønskede udfoldede form.
Da følerelementerne 30, 31 er fremstillet af et automatisk ekspanderende materiale, såsom nitinol, eller et tilsvarende element, der danner en elastisk 6 DK 2008 00058 U3 fremstående fod eller finger, er anordning 10 dækket af et fastholdelseshylster 42 for at fastholde følerelementerne 30, 31 i en sammenfoldet position, hvor sløjferne 31 er foldet på ringen 30 og som følge heraf ligeledes på trådnettet 20. Hylsteret 42 strækker sig frem for at dække kateteret 60. Et andet hylster 41, med i det væsentlige samme længde og uden indvirkning på følerelementerne 30, 31, er her tilsvarende tilvejebragt for at fastholde den bærende cylinder 20 i den sammenfoldede position, for således at undgå utilsigtet udfoldelse selv i fravær af oppustning af ballonen 3. De to hylstre 41, 42, er monteret koncentrisk på kateteret 60. Der er adgang til hylstrene 41 og 42 fra enden af kateteret 60 modsat anordningen 10. Elementerne 3, 41, 42, og 60 udgør en funktionel kateterenhed, der kan adskilles fra anordningen 10, til placering og ibrugtagning på sidstnævnte og dens nyttelast (2).
De to hylstre 41, 42 hæmmer den radiale udfoldelse af strukturen 20, 30, 31, indtil sidstnævnte når regionen for den native aortaventil 50, der funktionelt skal udskiftes, og muliggør som følge heraf introduktion af anordning 10 i blodcirkulationssystemet, såsom en inciseret arterie med reduceret diameter. Som anført, er kateteret 60, med ballonen 3, aftageligt fastgjort til implantationsanordningen 10 for således at muliggøre en aksial fremføring af Implantationsanordningen 10 i blodcirkulationssystemet op til implantationsplaceringen og tilbagetrækning af kateterenheden 3, 41, 42, 60.
Til frigørelse omfatter kateteret 60, i dette eksempel, i enden fastgjort til den bærende cylinder 20, en tang med fjedereffekt (ikke vist), med fjernstyrede tænder, monteret til at kunne rotere radialt, til fast forbindelse med anordningen 10 og har en glidende central fjernstyret metaltråd til aksialt at skubbe tangens forgreninger eller tænder tilbage for at adskille dem radialt og således frigøre kateteret 60 fra implantationsanordningen 10 ifølge sukkertangsprincippet.
Når det cylindriske trådnet 20 udfoldes, tilvejebringes trykket på aortas indvendige væg ved hjælp af effekten af formhukommelsen, hvilket som følge heraf sikrer den radiale udvidelse af protesen 1. Den svigtende native ventilklap 50 fladtrykkes ved presning mod det rørformede gitterværk 20 mod aortas indvendige væg, idet hver af de tre sløjfer 31 rager lateralt frem, da de tidligere 7 DK 2008 00058 U3 er blevet bragt i indgreb i én bestemt af de tre native ventilklapper 50 og tilsvarende presset for at bekræfte forankringen. Ventilklapperne 50 er som følge heraf fastklemt mellem trådnettet 20, 30 og de respektive sløjfer 31.
Implantationsfremgangsmåden for anordningen 10, der er beskrevet ovenfor, omfatter ifølge den foretrukne udførelsesform følgende trin. Efter indsætning af implantationsanordningen 10 i cirkulationssystemet, og efter at have skubbet den ved anvendelse af kateteret 60 til en position på opstrømssiden af den endelige målposition, her præcist hvor anordningen 10 ankommer i aorta, og således at en plads med en større diameter tilbydes den, består følgende trin i at frigøre de laterale sløjfer 31, der initialt presses mod det sammenfoldede trådnet 20, 30. Frigørelsen af sløjferne 31 sker ved tilbagetrækning af den udvendige fastholdelseskappe 42 (figur 2), dvs. tilbagetrækning mens trykket mod kateteret 60 fastholdes. Mens fremførslen af anordningen 10 fortsætter, udgør sløjferne 31, der derefter springer frem lateralt fremefter i forhold til fremførslens aksiale retning, modsat kateteret 60, en form for trefod og gennemtrænger samtidigt de tre respektive native ventilklapper 50, der i det væsentlige er identiske, idet de udgør et arrangement af forbindelseslommer i en komplet ring, der hver især strækker sig over 120 grader, og således optager hele omkredsen af den indvendige aortavæg 51. Hver native ventilklap 50 har en afrundet bund.
Hvert laterale fremspring 31, der er vendt fremefter, presses mod bunden af den pågældende native ventilklap 50, generelt i et givet punkt i en afstand fra denne bunds "laveste" punkt, dvs. længst væk fra kateteret 60. Der er som følge heraf tale om et delvist stop, fordi den aksiale fremføring af anordningen 10 fortsætter ved hjælp af kateteret 60's tryk, hvorved anordningen 10's aksiale tryk bevirker, at den glider til det laveste punkt. Bunden af ventilklappen 50 udgør som følge heraf en form for styrebane eller hældende plan (der ikke er retvinklet i forhold til aortas akse (62)) der, ved reaktion på den aksiale fremføringskraft, frembringer en periferisk reaktionskraft, der bevirker rotationen af anordningen 10, indtil den pågældende føiersløjfe 31 når det laveste punkt, der svarer til en komplet endevæg (med tangentplan vinkelret på aksen (62) af aorta 51), og 8 DK 2008 00058 U3 svarer som følge heraf til den endelige ønskede aksiale position og vinkelposition for anordningen 10.
Hvert laterale fremspring 31, med afrundede ender, her som en sløjfe, udgør således for at kunne glide i bunden af ventilklappen 50, ved kontinuerligt samarbejde med den afrundede bund af de native ventilklapper 50 med variabel dybde kontinuerligt, et rotationsmæssigt fremføringsmiddel til følerelementerne 30, 31 og som følge heraf ligeledes til det cylindriske trådnet 20, som det står i fast forbindelse med. Hvis de laterale fremspring 31 måtte støde mod en nativ ventilklap- 50 kommissur, kan implantationsanordningen 10 imidlertid trækkes lidt tilbage, og operatøren kan vride kateteret 60, således at det drejer vinkelmæssigt for at være i stand til at genstarte placerings- og forankringsoperationen.
Nar enheden, følerelementerne 30, 31 og det cylindriske trådnet 20, således er placeret aksialt og i en vinkel i forhold til aortas specifikke relief, som de native ventilklapper 50 udgør, placeres den følgelig automatisk i forhold til de to kransarterieåbninger (52), hvis aksiale position og vinkelposition i forhold til ventilklapperne 50 bestemmes og kendes, idet den aksiale afstand mellem ventilklapperne-kransarterierne naturligvis afhænger af patientens størrelse.
I det tilfælde, der betragtes her, hvori de tre native ventilklapper 50 danner en cirkelformet omkreds i forhold til aortavæggen strækkende sig over 360 grader, er et enkelt lateralt fremspring 31 tilstrækkeligt til modulus 120 grader placering og forankring af det cylindriske trådnet 20. Som anført ovenfor, i et generelt tilfælde, kan der kun være en enkelt føler 30, 31, der samarbejder med en række hulrum eller lommer dækkende hele omkredsen af det rørformede element, eller endog optager en enkelt lomme eller hulrum 50 kun en sektor af omkredsen og et antal følere 30, 31 hele vejen rundt om anordningen 10, således at én af dem samarbejder med hulrummet.
Det vil blive bemærket, i det foreliggende eksempel, at en modulus 120 graders placering kan tolereres, idet de to kransarterier (52) naturligt i det væsentlige har denne vinkel. Hvis det ikke var tilfældet, ville det være nødvendigt lateralt at 9 DK 2008 00058 U3 udvide to åbninger eller indsnit 22 tilvejebragt i kappen 21, således at de var placeret modsat kransarterierne (52) (figur 4 og position markeret på figur 3.), eller igen at føle ved hjælp af følerne 31 selve kransarterierne (52), der ligeledes udgør hulrum i aorta 51, og ikke længere at føle de native ventilklapper 50.
Dette tilfælde svarer til varianten, der er beskrevet nedenfor.
Når placeringen således er foretaget, består efterfølgende trin, som vist i figur 3, i at udfolde det cylindriske trådnet 20, der indvendigt bærer ventilklapperne 2, ved tilbagetrækning af det indvendige tilbageholdelseshylster 41, for at konsolidere forankring og skift af ventilklapperne 2 til deres funktionsform. For tegningens, især fremspringet 31's tydelighed, vises trådnettet 20 med en relativt lille diameter, mens det reelt svarer til aorta 5 l's, med et lille supplement for at sikre det ønskede laterale tryk. Der vises ligeledes to fremspring 31, selv om de reelt er adskilt med 120 grader, idet planet fra figur 3 alene i realiteten skærer ét. Af denne årsag er der kun tegnet en enkelt kransarterie (52).
De tre fremspringende sløjfer 31 tilvejebringer i sig selv en grundlæggende forankring i bunden af lommerne, som de native ventilklapper 50 udgør, og sikrer protesen l's placeringsstabilitet. Efter nogle uger begynder fibrøst væv at dække protesen 1 i samarbejde med de laterale fremspring 31 for yderligere forbedring af dens fastgørelse.
Det vil imidlertid blive bemærket, at det i følerelementerne 3l's udfoldede form ikke er nødvendigt, at deres frie ender skal presses hårdt mod væggen i aorta 51. Det er tilstrækkeligt, at deres radiale ekstension er tilstrækkelig til, at de under passage hager sig fast i ventilklapperne 50. Af den årsag, når følerelementerne 31 udfoldes på opstrømssiden af den endelige position, sker den senere aksiale translation af anordningen 10, op til denne position, uden "hård" gnidning undertryk, af delen af sløjferne 31 på aortavæggen 51. Sidstnævnte løber således ikke en risiko for beskadigelse på grund afskrabning eller gennemboring, idet sløjferne 31 er følere, der følger aortavæggen 51, for at detektere ventilklapperne 50. Som anført ovenfor, kan fødder eller tunger med afrundede ender ligeledes være egnede.
10 DK 2008 00058 U3 Følersløjferne 31 har følgelig ikke hertil hovedfunktion at forankre anordningen 10 på en meget fast måde i aorta 51, da de ikke har til formål at udøve et meget stort radialt forankringstryk. Som anført ovenfor, er der kun tale om en elementær forankring. Det er derefter den radiale udfoldelse af trådnettet 20, der ved formhukommelse skaber et definitivt radialt forankringstryk, som tvinger trådnettet 20 under tryk mod aortavæggen 51 og som følge heraf blokerer enhver relativ bevægelse, såsom tilbagetrækning af anordningen 10, der kunne skyldes blodstrømningen, i en retning modsat indsætningen af anordningen 10. Følerelementerne 31 er derefter funktionelt overflødige. De bidrager imidlertid til fastholdelse af positionen ved ventilklapperne 2's klemmen. Da trådnettet 20 giver en relativ stor kontaktflade med aorta 51, er enhver risiko for ødelæggelse af sidstnævnte udelukket.
Formhukommelsesmaterialet gør det muligt præcist at bestemme det radiale tryk, der udøves på aorta 51, idet den således øgede diameter af sidstnævnte derefter er perfekt defineret, hvilket eliminerer samtlige risici for excessiv radial belastning.
Det vil blive bemærket, at implantationsanordningen ifølge opfindelsen først kan implanteres alene, uden implantat eller nyttelast, idet sidstnævnte implanteres senere derpå ifølge det samme princip. I sådan et tilfælde omfatter anordningen ifølge opfindelsen midler til modtagelse af den anden, kommende, støtte, til implantatet, hvilke midler er indrettet til at sikre placering og forankring, bide aksialt ved stop og radialt med korrigerende midler til vinkelfejl, såsom en finger eller et hulrum, der er beregnet til at samarbejde med et element af komplementær form i den anden støtte.
I varianten, der vises i figur 7, har implantationsanordningen referencen 110 og omfatter funktionselementer svarende til anordning 10's med de samme referencer med hundrede foran 1, der imidlertid ikke alle vises af hensyn til tydeligheden. Det cylindriske bærende element 120 er fast forbundet med et følerelement 131, der stikker frem lateralt, og som har den samme konstruktionstype som bæreelementet 120. Følerelementet 131 fremstår netop i form af en cylinder, der er sammenfoldet radialt i hvilepositionen. Nar 11 DK 2008 00058 U3 anordningen 110 skubbes af kateteret 160, i retning af bunden i figur 7, fra en position på opstrømssiden af den viste, sættes den i indgreb i kransarterien 52, når dens frie ende således frigøres fra kontakt med den indvendige væg af aorta 51.
5 Anordningen 110 udgør således en form for gaffel, der blokeres ved stop i gaffeldelingen mellem aorta 51 og kransarterien 52. Når stoppositionen er nået, udfoldes de to cylindriske elementer 120, 131 ved hjælp af de to respektive balloner og danner en form for en to-finger-handske.
Under placeringsfasen har føleren 131 således en radialt sammenfoldet form, 10 som følge heraf med en reduceret diameter, der ikke risikerer at blokere kransarterien 52. Derefter udfoldes føleren 131 ved oppustning af ballonen forbundet med fjernstyring og udgør en foring, eller en indvendig "kappe", der presses mod den indvendige væg af kransarterien 52 ifølge princippet, der er forklaret ovenfor for den bærende cylinder 20.
15 Det vil blive bemærket, da elementerne 120 og 131 hver optager en særlig forgrening 51, 52, at de kan betragtes som funktionelt ækvivalente med eventuelt de to hovedfunktioner. Hvert af dem kan reelt være bærer af en nyttelast (2) og kan ligeledes betragtes som værende en føler, idet aorta 51 kan betragtes (funktionelt som led i den foreliggende opfindelse) som værende et 20 hulrum eller en forgrening i forhold til kransarterien 52. Følerne omfatter således et cylindrisk element 131, der er indrettet til skifte fra en sammenfoldet form til en radialt udfoldet form med støtte mod en væg af hulrummet, her kransarterien 52, under påvirkning af fjernstyrede kontrolmidler (ballon og kateter 160).
25 For at undgå risici ved føleren 131's skift til koblingsposition til kransarterien 52, der skyldes en vinkelmæssig forskydning, som måtte kræve flere forsøg, kan der tages højde for at lade en styretråd passere ind i kransarterien 52 og delen opstrøms for aorta 51, hvilken anordning 110 stikkes ind over føleren 131, der vinkel mæssigt vender i retning af kransarterien 52. En anden styretråd kan 30 samtidigt styre cylinderen 120 ind i aorta 51.
Claims (9)
1. Anordning til implantation af et implantat (2) på en bestemt position i et rørformet element (51) med en væg omfattende et hulrum (50, 52), hvilken anordning (10) er indrettet til at samarbejde med midler til fremføring (60) af anordningen i det rørformede element (51), hvilken anordning er kendetegnet ved, at den omfatter følere (30, 31, 131), der er deformerbare og indrettet til, under kontrol af fjernstyrede kontrolmidler (42), at skifte fra en sammenfoldet form til en funktionel udfoldet form, for at detektere hulrummet (50, 52) og at placere sig selv der med reference til dettes position.
2. Anordning ifølge krav 1, hvori følerne (30, 31) er fremstillet af et materiale med formhukommelse.
3. Anordning ifølge et af kravene 1 og 2, hvori de fjernstyrede kontrolmidler er aftagelige og omfatter et tilbageholdelseshylster (42) til at bevare følerne (30, 31) i den sammenfoldede form, hvilket hylster strækker sig ud over følerne (30, 31) for at frigøre dem ved relativ tilbagetrækning af hylsteret i forhold til et trådelement (60) til fremføring af anordningen ved skub.
4. Anordning ifølge et af kravene 1 til 3, hvori følerne (30, 31) omfatter en ring, af generelt cylindrisk form med en radial retning, af sløjfer (31) fremstillet af en tråd med en begrænset stivhed i den radiale retning, hvori mindst én af sløjferne (31) er indrettet til at fremstå lateralt for således at udgøre en føler.
5. Anordning ifølge et af kravene 1 til 4, hvori følerne (30, 31) omfatter et antal følefingre (31), der er regelmæssigt fordelt vinkelmæssigt og indrettet således, at de, i den udfoldede form, strækker sig I respektive hældende retninger, i spidse vinkler på en langsgående fremføringsakse (62) fremefter fra anordningen i retning af hulrummet (50).
6. Anordning ifølge et af kravene 1 til 5, hvori følerne (30, 31) er forbundet med deformerbare modtagelsesmidler (20) til et implantat (2), der er indrettet således, at den, under virkningen af frigørelsesmidlerne (41), skifter fra en Inspicos/27/Q6/2008/ll:ll 13 DK 2008 00058 U3 sammenfoldet form til en radialt udfoldet form, med pres mod væggen af det rørformede element (51) og anvendelse af implantatet (2).
7. Anordning ifølge krav 3 og 6 sammen, hvori midlerne (20) til at modtage implantatet (2) omfatter et trådnet i en generelt cylindrisk form med en aksial 5 retning til at bære implantatet, med en begrænset stivhed i den aksiale retning, og frigørelsesmidlerne indbefatter et bevægeligt hylster (41) til at fastholde det bærende trådnet (20) i den sammenfoldede position, strækkende sig aksialt ud over trådnettet for at frigøre det ved hjælp af en relativ aksial tilbagetrækning af hylsteret (42) i forhold til et trådelement (60) til at fremføre anordningen ved 10 skub, idet hæmnings- og fastholdelseshylstrene (41, 42) er koncentriske.
8. Anordning ifølge et af kravene 6 og 7, hvori midlerne til modtagelse (20) af et implantat er dækket af en lateral forseglingskappe (21), der er beregnet til at blive presset mod væggen af det rørformede element (51) ved hjælp af disse, og kappen (21) mindst omfatter en åbning eller et indsnit (22), der indtager en 15 vinkelposition bestemt i forhold til følerne.
9. Anordning ifølge et af kravene 1 til 8, hvori følerne (131) omfatter et cylindrisk element, der er indrettet til skifte fra en sammenfoldet form til en radialt udfoldet form, med støtte mod en væg af hulrummet (52) under påvirkning af fjernstyringsmidler.
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FR0110444A FR2828263B1 (fr) | 2001-08-03 | 2001-08-03 | Dispositif d'implantation d'un implant et procede d'implantation du dispositif |
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US9949824B2 (en) | 2001-08-03 | 2018-04-24 | Jenavalve Technology, Inc. | Devices useful for implantation at a heart valve |
US11007052B2 (en) | 2001-08-03 | 2021-05-18 | Jenavalve Technology, Inc. | Devices useful for implantation at a heart valve |
US11357624B2 (en) | 2007-04-13 | 2022-06-14 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US10993805B2 (en) | 2008-02-26 | 2021-05-04 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11589981B2 (en) | 2010-05-25 | 2023-02-28 | Jenavalve Technology, Inc. | Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent |
US11185405B2 (en) | 2013-08-30 | 2021-11-30 | Jenavalve Technology, Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
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