SE445884B - Anordning for implantation av en rorformig protes - Google Patents

Anordning for implantation av en rorformig protes

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Publication number
SE445884B
SE445884B SE8202739A SE8202739A SE445884B SE 445884 B SE445884 B SE 445884B SE 8202739 A SE8202739 A SE 8202739A SE 8202739 A SE8202739 A SE 8202739A SE 445884 B SE445884 B SE 445884B
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SE
Sweden
Prior art keywords
wires
tubular body
diameter
tubular
threads
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SE8202739A
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English (en)
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SE8202739L (sv
Inventor
H I Wallsten
Original Assignee
Medinvent Sa
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=20346693&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SE445884(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to SE8202739A priority Critical patent/SE445884B/sv
Application filed by Medinvent Sa filed Critical Medinvent Sa
Priority to BR8307541A priority patent/BR8307541A/pt
Priority to PCT/SE1983/000131 priority patent/WO1983003752A1/en
Priority to GB08411519A priority patent/GB2135585B/en
Priority to NL8320142A priority patent/NL192600C/nl
Priority to AU15186/83A priority patent/AU1518683A/en
Priority to JP58501556A priority patent/JPS59500652A/ja
Priority to DE19833342798 priority patent/DE3342798T1/de
Priority to CH6701/83A priority patent/CH662051A5/de
Priority to BE0/210667A priority patent/BE896616A/fr
Priority to CA000427014A priority patent/CA1239755A/en
Priority to IT20864/83A priority patent/IT1169405B/it
Priority to FR838307145A priority patent/FR2525896B1/fr
Publication of SE8202739L publication Critical patent/SE8202739L/sv
Priority to US06571549 priority patent/US4655771B1/en
Priority to DK605483A priority patent/DK159368B3/da
Publication of SE445884B publication Critical patent/SE445884B/sv
Priority to US07330975 priority patent/US4954126B1/en
Priority to NL9700006A priority patent/NL192972C/nl

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0105Open ended, i.e. legs gathered only at one side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/011Instruments for their placement or removal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • DTEXTILES; PAPER
    • D04BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04CBRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06Braid or lace serving particular purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/016Filters implantable into blood vessels made from wire-like elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/005Rosette-shaped, e.g. star-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Textile Engineering (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)

Description

IH 15 ZS 30 35 8202739-2 2 ning, vilken efter införande i exempelvis ett blodkärl kan bringas att expandera. Den expanderbara delen av denna anord- ning baserar sig på användning av metallegeringar med s.k. "min- nesfunktion", dvs. ett material, som vid uppvärmning kan över- gå till en tidigare form som det bibringats. Materialets upp- värmning sker vid denna kända teknik genom elektrisk upphett- ning med anordningen införd på det aktuella stället. Denna kända teknik uppvisar emellertid den väsentliga olägenheten att elektrisk motståndsupphettning måste ske i anslutning till omgivande känslig vävnad eller kroppsvätska, som vid upphett- ningen kan ta skada. Visserligen anges i patentskriften (jfr. raderna 42-48), att vid anordningens införande i ett blodkärl patientens blod tjänar som kylmedium. Emellertid utgör även blod ett värmekänsligt material, vilket vid upphettning kan koa- gulera på ett icke önskvärt sätt.
SAMMANFATTNING AV UPPFINNINGEN Föreliggande uppfinning har till ändamål att åstadkomma en expanderbar resp. kontraherbar anordning, vid vilken de med den kända tekniken behäftade nackdelarna undvikes.
Föreliggande uppfinning baserar sig på utnyttjning av en anordning innefattande en flexibel rörformig kropp, vilken är sammansatt av ett flertal enskilda styva men flexibla trådar, av vilka var och en sträcker sig i skruvlinjespiral med kroppens centrumlinje som gemensam axel. Härvid har ett antal trådar samma skruvriktning men är fasförskjutna, dvs. axiellt förskjut- na i förhâllande till varandra. Nämnda antal trådar med samma skruvriktning möter korsande ett antal trådar, vilka även de är axiellt förskjutna i förhållande till varandra men förlöper med motsatt skruvriktning. Anordningen enligt uppfinningen in- nefattar därjämte organ, vilka är anordnade att förlänga eller förkorta kroppen under minskning resp. ökning av dess diameter.
Sistnämndu organ är så anordnade, att de efter implantatio- nen kan lösgöras från kroppen och avlägsnas från implantations- stället, varjämte kroppens radiellt expanderade läge i huvudsak motsvarar obelastat tillstånd hos i kroppen ingående trådar.
Det är föredraget att anordna de varandra korsande trådar- na så, att de bildar någon form av flätad konfiguration, som kan varieras alltefter önskemål och exempelvis efterlikna någon (fl 10 30 s 8202739-2 inom vävtekniken känd vävnadstyp, exempelvis enligt principen Syftet härmed är att bibrínga den rörformiga Om antalet trådar i den flexibla tvâ-skaftvävnad. kroppen erforderlig stadga. rörformiga kroppen betecknas med n är det föredraget att n vari- erar från ca 10 till ca 50. Trädarna i den rörformiga kroppen är företrädesvis symmetriskt anordnade, dvs. antalet trådar i varje skruvriktning är n. Det bör observeras att i detta samman- ') (4 hang aVsëeflde aIlïl-filßtgïTådflf i den rörfonniga kroppen avses hela tiden trådar avsedda att upprätthålla bärande funktion i kroppen. An- talet trådar n utväljes alltefter kroppens diameter, trådens dia- Helt all- mänt gäller att ju större kroppens diameter är vid ett givet meter, materialet i tråden eller övriga förhållanden. trådmaterial desto fler trådar bör användas för uppnående av er~ forderlig stadga hos kroppen. Nedan anges tre exempel pä utföríngsformer, varav dimensionsförhållanden och antalet trådar framgår. de.
Dessa exempel får dock icke betraktas såsom inskränkan- a) Diameter hos den rörformiga kroppen 10 mm, tråd i den- samma monofilament i dakron, diameter 0,2 mm, antal trådar n = 24, dvs. 12 trådar i varje skruvriktning. b) Diameter hos den rörformiga kroppen 20 mm, tråd i den- samma monofilament í teflon, diameter 0,5 mm, antal trådar n = 12, dvs. 6 trådar i varje skruvriktníng. c) Diameter hos den rörformiga kroppen 15 mm, tråd i den- samma av rostfritt stål, diameter 0,1 mm, antal trådar n = 40, dvs. 20 trådar i varje skruvriktning.
Den flexibla rörformiga kroppen, som ingår i anordningen enligt föreliggande uppfinning, har visat sig vara mycket lämp- pad att användas som protes för insättning i blodkärl eller andra liknande organ i kroppen. Den rörformiga kroppen införes härvid på plats i organismen i kontraherat tillstånd, dvs. med reducerad diameter. När anordningen enligt uppfinningen in- förts på plats bríngas den rörformiga kroppen att expandera och kan i expanderat skick kvarstanna genom självfíxering, om kroppens expanderade diameter väljes något större än blodkär- lets diameter. Härigenom erhålles ett visst permanent anligg- ningstryck mot kärlväggens inre så att på så sätt g0d fíXGTiHQ tillförsäkras. lU 15 20 30 8202739-2 4 Vid tillämpning av tekniken enligt föreliggande uppfinning för kirurgiska ingrepp i människokroppen är den rörformiga kroppens diameter i kontraherat eller hopdraget tillstånd lämp- Diametern i expanderat tillstånd Det utgör endast en fackmannamässíg ligen ej större än 8 - 10 mm. kan ligga mellan lZ - 30 mm. åtgärd att välja trådparametrarna på lämpligt sätt med avseende på tråddiameter, antal, material etc. När det gäller trådformen kan naturligtvis tvärsnittet variera alltifrån cirkelrunt tvär- snitt till ovalt, fyrkantigt, dvs. kvadratiskt eller rektangu- lärt etc.
Trådarnas fria ändar i den rörformíga kroppen kan modifie- ras eller skyddas på ett flertal sätt. Det alternativ, vid vil- ket inga fria ändar över huvud taget förekommer är alternativet att utföra den rörformiga kroppen i sin helhet av en enda sam- manhängande tråd. Det alternativ som närmast liknar detta är det fall att man sammanfogar de friliggande ändarna i en kropp som tillkommit genom avklippning av en lång sträng med U-formiga an- slutningsdelar som sammanfogas med trådarnas ändar parvis på lämpligt sätt, exempelvis värmesvetsning, limning e.dyl. Härvid kan parvis sammanfogas trådar med samma skruvriktning eller trå- dar med motsatt skruvriktning.
Ett alternativ till dessa utföringsformer är att man före materialsträngens avklippning genom elektrisk motstândsupphett- ning eller liknande sammansvetsar korsningspunkterna i en ring runt materialetyarefter avklippning sker intill och strax utanför sammansvetsningsstället. De ändar som sedan sticker ut utanför svetsområdet kan sedan vikas inåt mot kroppens inre under lätt plastisk deformation, exempelvis genom kontrollerad upphettning.
Ytterligare ett alternativ består i att trådarnas fria ändar om- böjes till bildning av öglor.
Den flexibla rörformiga kroppen kan bringas att expandera på ett flertal sätt. Det har befunnits att det av många skäl är att föredra, om kroppen besitter den egenskapen, att den av sig själv i obelastat tillstånd intar expanderat läge. Kroppens utseende i obelastat tillstånd kan vara betingat av de i krop- pen ingående trädarnas egen styvhet. Kroppens expanderade till- stånd kan även vara betingat av elastiska trådar eller band, vilka är anordnade i anslutning till kroppens mantelyta och 20 30 35 8202739-2 U1 Genom sin elasticitet strä- dra sträcker sig axíellt längs denna. var dessa trådar eller band efter att axiellt ihop krop- pen dvs. bringa den att inta expanderat tillstånd.
Ett alternativt sätt att bíbringa kroppen egenskaper, genom vilka den strävar efter att inta radiellt expanderat läge, är att fixera trådarna till varandra i korsningspunkterna och på lämpligt sätt, exempelvis genom någon form av svetsning, límning e.dyl.
De i den flexibla rörformiga kroppen ingående trådarna kan vara utförda av medicinskt fördragbart material, exempelvis plast eller metall, och de bör uppvisa viss spänst eller styvhet före- nad med lämplig elasticítet. Trådarna kan vara uppbyggda som monofilament eller utgöras av ett sammansatt material, exempel- vis av teflon, dakron eller annan lämplig plast. De kan även utgöras av någon lämplig medicinskt fördragbar metall, exempel- vis stål.
Såsom tidigare antytts är den rörformiga kroppen ingående i anordningen enligt föreliggande uppfinning lämpad för använd- ning som s.k. graft. Härvid kan kroppen som sådan fungera som graft nämligen om den utföres av trådar av sådan karaktär att de själva ger kroppen önskad täthet för att fungera som graft.
Al- ternativet till att trådarna som sådana ger önskad täthet åt Härvid kan trådarna utgöras av vävt material, garn e.dyl. kroppen är att påföra den någon form av ytskikt, exempelvis av plast, folie eller annat lämpligt material. Genom pâförande av ett sådant ytskikt genom exempelvis sprayning kan samtidigt åstadkommas låsning av korsníngspunkterna, såsom antytts ovan, så att kroppen härigenom strävar efter att inta expanderat läge.
Utanpâ kroppen kan före fixeríngen även anordnas ett fri- stående separat hölje. tande strumpa av porös väv, vilken kan ínplanteras på avsedd Detta kan utgöras av en kroppen omslu- plats tillsammans med kroppen. Strumpan kan härvid antingen genom töjbarhet i väven eller genom överlappande vikning eller på annat sätt vara anpassningsbar till kroppen i samband med dennas expansion. Man kan även tänka sig användning av någon form av trikåväv eller krepad vara. Vid användning av ett sådant fristående separat hölje är det föredraget att höljet är axiellt fixerat relativt kroppen så att den vid applice- ringen i ett stort kärl eller dylikt hamnar på rätt plats í LU 15 rv Lfi 30 82ß2739°2 6 förhållande till kroppen.
Såsom tidigare nämnts åstadkommes den rörformiga kroppens expansion resp. kontraktion genom organ, vilka är anordnade att förlänga eller förkorta kroppen. Sådana organ kan vara utformade på en mångfald olika sätt så länge som deras konstruk- tion tillåter förflyttning av kroppens ändar axiellt i förhål- lande till varandra för minskning resp. ökning av kroppens dia- meter. Anordningen bör sålunda innefatta griporgan, varmed kroppens ändar kan gripas och förflyttas axiellt relativt varand- ra, vilka griporgan bör vara anordnade för att kunna lösgöras efter kroppens applicering på avsedd plats så att anordningen i övrigt kan avlägsnas från platsen ifråga.
Helt allmänt kan sägas att anordningen enligt föreliggande uppfinning lämpligen innehåller en cylíndrisk rörformig lång- sträckt bärarkropp, vilken är anordnad inne i den rörformíga kroppen. Denna bärarkropp är vid ändarna försedd med gripor- gan för den rörformiga kroppens ändar, vilka griporgan kan för- flyttas axiellt relativt varandra och vilka kan lösgöras från den rörformiga kroppens ändar efter dennas applicering. Grip- organen kan vara manövrerbara via någon form av koaxíalkabel, vilken vid den yttre änden är försedd med manöverorgan för griporganens axiella förskjutning resp. deras lösgöring från den rörformiga kroppen.
I övrigt framgår anordningens kännetecken av bilagda pa- tentkrav.
EXEMPEL Uppfinníngen kommer i det följande att beskrivas genom upp- finningen icke inskränkande men exemplifierande utföringsformer i anslutning till bilagda ritning. På denna illustreras dessa utföringsformer och: fig. la och fíg. lb visar schematiskt en sidovy resp. en ändvy av den flexibla rörformiga kroppen enligt uppfinningen; fig. Za och fig. Zb visar samma rörformiga kropp som i fig. 1 men i kontraherat tillstånd; -v fig. J och fíg. 4 visar en enskild i kroppen ingående tråd med kroppen i kontraherat resp. expanderat tillstånd; fig. 5 visar schematiskt en sammanställning av en utförings- form av anordningen enligt föreliggande uppfinning; 10 15 35 1 8202739-2 fig. 6 visar i förstoring en del av anordningen i fig. 5; fig. 7 visar en alternativ utföríngsform av den rörformiga kroppen; fig. 8 visar den rörformiga kroppen utformad som en kombi- nerad graft och filter; fig. 9 visar den rörformiga kroppen använd i anslutning till anevrism; och fig. 10 visar exempel på alternativa griporgan för den rörformiga kroppens ändar.
I fig. la och lb visas ett exempel på en cylindrisk rör- formig kropp generellt betecknad 1. Som framgår av fig. la bildas kroppens l mantelyta av ett antal enskilda trådar 2,3 etc. resp. 2a,3a etc. Av dessa trådar sträcker sig trådarna 2,5 etc. i skruvlinjespiral fasförskjutna i förhållande till varand- ra med kroppens l centrumlinje 7 som gemensam axel. De övriga trådarna Za, Sa etc. sträcker sig i skruvlínjespiral åt motsatt håll, varigenom de i de båda riktningarna förlöpande trådarna korsar varandra på sätt som framgår av fig. la.
Diametern för en på detta sätt uppbyggd rörformig kropp kan förändras om kroppens ändar förskjutes axiellt i förhållan- de varandra i centrumlinjens 7 riktning. I fíg. Za äskädliggöres hur den rörformiga kroppen l enligt fig. a bibringats minskad diameter genom att ändarna 8,9 fjärmats från varandra i pilar- nas riktning. Av fíg. lb framgår den rörformiga kroppens dia- meter i expanderat tillstånd, medan fíg. Zb visar kroppens 1 diameter i kontraherat tillstånd efter det att ändarna 8,9 fjär- mats från varandra.
Pig. 3 och 4 visar en detalj hämtad ur fig. l och 2, när- mare bestämt en enstaka tråd av den rörformiga kroppen 1 och hur dess kruvlinjesträckning förändras i anslutning till för- ändringen av den rörformiga kroppens 1 längd.
I fig. 3 visas den enskilda tråden 10 motsvarande tråden 10 i fig. Za. Skruvlinjens diameter är dl och trâddelens längd ll . I fig. 4 visas samma tråd 10 sedan den rörformiga kroppen bringats att expandera till det läge som visas i fig. la. Skruv- linjens diameter har nu ökat och betecknas dz medan längden minskat och betecknas 1) . I stort sett råder det sambandet, att man för att åstadkomma fördubblad diameter måste minska längden till ungefär hälften. (Obsï att i fíg_ 3 Qçh 4 är de 10 15 30 SS 8202739-2 inbördes proportionerna för trådavsnittet överdrivna i syfte att tydligare visa effekten av längdförändringen).
Den rörformiga kroppen 1 kan bringas att expandera på en mångfald sätt. Såsom tidigare nämnts är det att föredra om kroppen inherent uppvisar den egenskapen, att den av sig själv i avlastat skick intar expanderat läge. I föreliggande fram- ställning avses med uttrycket “expanderat läge" hela tiden radi- ell expansion, dvs. ett läge med den större diametern hos krop- pen l. Den självexpanderande egenskapen kan åstadkommas genom att kroppen förses med trådar eller band, vilka sträcker sig parallellt och axiellt i anslutning till kroppens l mantelyta.
Ett exempel på en sådan utföringsform visas i fig. 7, där den rörformiga kroppen l är försedd med axiella trådar eller band ll.
Dessa trådar eller band ll är lämpligen utförda av elastiskt material och är i obelastat tillstånd med den rörformiga kroppen l i expanderat tillstånd fixerade till trådarna i kroppen på lämpligt sätt. Om nu den rörformiga kroppen l förlänges axiellt genom att de båda ändarna avlägsnas från varandra kommer de elastiska trådarna eller banden ll att tänjas ut. När sedan dragkraften på kroppen 1 avlägsnas kommer de elastiska trådarna eller banden ll att dra ihop kroppen l i axiell led, vilket leder till en motsvarande ökning av kroppens diameter.
Den rörformiga kroppen l kan bibringas samma strävan att inta expanderat läge genom att såsom tidigare nämnts trådarna 2,3 etc.; 2a,3a etc. fixeras i sina korsningspunkter 5,6 (fig. 1).
Ett ytterligare sätt att åstadkomma denna effekt är att invän- digt eller utvändigt anordna ett rörformígt elastiskt organ, t.ex. av en tunn elast, vilket är fastsatt åtminstone i den rörformiga kroppens båda ändar.
I fig. 5 visas en anordning generellt betecknad 18 för att möjliggöra införande av den rörformiga kroppen 20 i kontraherat och förlängt tillstånd på önskad plats i exempelvis ett blod- kärl. Den rörformiga kroppen 20 omsluter apparatens 18 främre rörformiga del 19 och är vid sina båda ändar fastsatt vid fast- hållningsorgan Zl och 22. Apparatens främre rörformiga del 19 är via ett flexibelt rörformigt organ 23 anslutet till en manö- verdel 24. Medelst manöverorgan 25,26 och Z7 i manöverdelen 24 kan fasthållningsorganen 21 och 22 manövreras på önskat sätt.
I fig. S visas schematiskt hur apparaten 18 med den kon- 10 15 30 9 8202739-2 traherade rörformiga kroppen Z0 införs på plats i exempelvis ett blodkärl, vilket i figuren streckuts och betecknats 28.
Manöverdelen 24 är förbunden med fasthållníngsorganet 22 på ett sådant sätt, att när manöverorganet 26 föres framåt till det punktstreckade läget 29 fasthâllningsorganet 22 förskjutes på motsvarande sätt till det punktstreckade läget 30. Härigenom har den rörformíga kroppens 20 ände förskjutíts från läget 22 till läget 30, medan i detta fall kroppens andra ände förblivit i läget"Zl. Samtidigt har kroppens 20 diameter ökat och när änden intagit läget 30 är kroppen 20 fullt expanderad, dvs. den har bríngats i kontakt med den inre kärlväggen och intar det punktstreckade läget 31. Eftersom den rörformiga kroppens 20 båda ändar fortfarande fasthålles av organen 21,22 intar krop- pen 20 i expanderat tillstånd en ballongliknande form.
Manöverorganet 27 står likaså i förbindelse med fasthåll~ ningsorganet 22 medelst en i det rörformiga organet 23 löpande del, t.ex. en vajer. På detta sätt kan genom axiell förskjut- ning av manöverorganet 27 fasthållningsorganet 22 i sitt läge Pâ samma sätt fasthållnings- 30 manövreras för att frigöra kroppens 20 ände. kan manöverorganet 25, som står i förbindelse med rörformiga 21. elastiska kroppens 20 ändar underkastas därvid omedelbart organet 21, genom axiell förskjutning frigöra den kroppens 20 främre ände från fasthâllníngsorganet Den expansion och protesen intar sin expanderade cylíndriska form i blodkärlets inre.
I fig. 6 visas mera i detalj och i förstoring konstruk- tionen av anordningens 18 främre rörformiga del 19. Den rör- formíga kroppen 20 med sina båda ändar 32 och 33 omsluter ett tunnväggigt böjligt rör 34, vilket löper invändigt i och kon- centriskt i förhållande till ett yttre flexibelt rör 35, vilka rör båda tillsammans bildar det rörformiga organet 23 i fig. 5.
I den främre delen av det inre röret 34 är ett ringformat or- gan 36 anordnat, i vilket änden 32 av röret 20 är införd. På motsvarande sätt är rörets 20 ände 33 införd i ett ringformat organ 37, vilket är förskjutbart anordnat i axiell led i för- hållande till det rör 34, som omslutes av ringen 37. 34 främre del är invändigt ett fasthâllningsorgan eller hake Haken 38, vilken lämpligen är utförd av fjäder- I rörets 38 anordnad. stål, har en främre under ungefär rät vinkel avböjd spetsig 10 15 30 35 8202759-2 10 Denna del 39 sträcker sig radiellt utåt genom ett hål Den kan bringas att röra sig i radiell rikt- del 39. i rörväggen 34. ning genom inverkan av en ring 40, som är axiellt förskjutbar och anordnad inuti röret 34. Ringen 30 är ansluten till en vajer 41, genom vars förskjutning axiellt haken 38 kan bringas att röra sig i radiell riktning. I fig. 6 visas haken 38 i ett sådant läge, att dess spetsiga del 39 perforerat änden 32 av kroppen 20 och på detta sätt fasthåller änden.
På motsvarande sätt är en annan hake 42 anordnad att med sin spetsiga del 43 utifrån fasthålla änden 33 av den rörformi- ga kroppen 20. Denna hake 42, som är utvändigt fastsatt på röret 35, kan bríngas att röra sig i radiell riktning medelst en ring 44, som är anordnad omkring röret 35 och fastsatt vid en kabel 45, som sträcker sig mellan rören 34 och 35. Kaplarna 44 och 45 är anslutna till manöverorganen 25 resp. 27 i fig. 5.
När den fastspända och axiellt utdragna rörformíga kroppen 20 skall frigöras från anordningen i övrigt efter kroppens ra- diella expansion sker detta genom att de spetsiga delarna 39,43 av hakarna 38 resp. 42 frigöres från den rörformiga kroppens 20 ändar genom att manöverorganen 25 och 27 via kablarna 41 och 45 bringar ringarna 40 och 44 att pressa ut hakarna 38 och 42. Krop- pens 20 ändar 32 och 33 frigöres sedan genom axiell förskjutning av apparatens rörformiga del 19. Såsom framgår av fig. 6 är apparatens främre ände skyddad av en hätta eller kåpa 46, som är fastsatt vid ringen 36.
Såsom tidigare nämnts kan den expanderbara rörformiga krop- pen användas vid ett flertal tillämpningar inom kirurgin. Den kan exempelvis i utföringsformen enligt fig. l utnyttjas för att vidga kärlväggar. I fig. 8 visas en modifierad utförings- form av den flexibla rörformiga kroppen. Vid denna utförings- form består kroppen av en cirkulärcylíndrisk del S3, som vid den ena änden övergår i en avsmalnande del eller gavel S4, vil- ken även den är uppbyggd av trådar. Denna anordning har be- funnits lämplig för användning som sil eller filter för att förhindra tromboser. Den i fig. 8 visade anordningen kan appliceras på önskat ställe inne i ett blodkärl, exempelvis Vena Cava Inferior i syfte att förhindra lungemboli. Tidigare kända filterorgan avsedda för placering inne i blodkärl i syfte att fånga upp tromboser är behäftade med den nackdelen, att de 10 15 ZU 35 U 8202739-2 permanent fixeras i blodkärlet genom spetsar eller hakar e.dyl., varigenom lägeskorrigering eller uttagning av filtret icke är möjligt. Exempel på en sådan anordningen beskrivas i U.S.-pa- tentet 3 540 413. kan appliceras på plats i Vena Cava med stor precision och den Anordningen enligt föreliggande uppfinning medför icke någon risk för skador på omgivande kärlväggar, vilket är fallet med de kända anordningar som idag inom kirurgin användes för samma ändamål.
I fig. 9 visas en som protes användbar rörformig kropp av- sedd att ingå i anordningen enligt föreliggande uppfinning. I detta fall har kroppen 55 en betydligt tätare vägg än den i fig. 1 och 2 visade utföringsformen. Denna tätade vägg kan åstadkommas genom att ett elastiskt garn inväves mellan de bärande trådarna 2,3 etc; 2a,3a etc. i fig. 1. På detta sätt kan en vägg med kontrollerad porositet åstadkommas. Denna rör- formiga kropp med mer eller mindre porös vägg utgör sålunda en form av expanderbar graft och har mångsidig användning.
Vid den i fig. 9 visade tillämpningen är kroppen 55 inplan- terad i en aorta 56, i vilken föreligger en aneurism 57 i form av en utbuktning av kärlväggen. Genom att den expanderbara kroppen eller graften S5 kan införas på avstånd från det ska- dade stället i aorta och därefter placeras mitt för aneurismen överbryggas densamma och behöver icke avlägsnas operativt. I fig. 9 antydes även det förhållandet, att aorta är ett koniskt blodkärl. Tekniken blir därför i detta fall att protesen i form av en graft införes med ett instrument exempelvis i en- lighet med fig. 5. eller kroppen S5.
När den kommit på plats expanderas graften På grund av aortas konicitet blir opera- tionstekniken följande.
Graftens 55 främre ände 31 enligt fig. 5 föres något läng- re ín i aorta än den plats där den skall befinna sig efter av- slutad operation. Detta läge S9 betecknas i fig. 9 med punkt- streckad linje. Den axiellt uttänjda graftens 55 andra ände 22 enligt fig. 5 föres före den radiella expansionen fram till slutläget, som motsvarar läget 60 i fig. 9. Eftersom denna del av aorta har något mindre diameter än diametern före aneu- rismen sett uppströms i förhållande till denna kan protesen ej expandera mer än som motsvarar diametern vid anden 00. Detta avhjälpes emellertid genom att man med den främre delen av in- V1 10 IS ZU hå 'J1 SU 8202739-2 1: strumentet därefter förflyttar graftens 55 andra ände från läget 59 till läget 58, så att denna ände av graften kan expandera tillräckligt för att bringas till anliggníng mot denna del av kärlväggen.
Den i fig. 6 mera i detalj visade anordningen för att an- bringa den cylindriska kroppen invändigt i exempelvis blodkärl kan givetvis utföras på annat sätt än vad som beskrivits i form av exempel. Det väsentliga är emellertid att apparaten är försedd med fasthållningsorgan för den rörformiga kroppens båda ändar, vilka organ kan lösgöras från kroppen sedan den bringats att expandera på önskat ställe. Härvid åstadkommes expansion- en genom axiell förskjutning av kroppens båda ändar mot varand- ra genom att fasthållningsorganen bringas att röra sig axi- ellt i riktning mot varandra.
I fig. 10 visas ett exempel på en annan utföringsform av fasthållningsorgan för den rörformiga kroppen. Dessa organ be- står av ett antal klämbackar 50, vilka är ledbart lagrade kring axlar 51, så att dessa med i och för sig kända och på ritningen ej visade organ kan bríngas inta öppnat läge, vilket visas med det streckade läget S2. Det har visat sig att inga speciella fasthållníngsorgan motsvarande hakarna 38 och 42 i fig. 6 er- fordras. Den rörformiga kroppen fasthålles i utdraget läge med liten diameter av klämbackarna 50, som pressar kroppens ändar till anliggning mot röret 34 i fig. 6. När expansion ägt rum och kroppens ändar skall frigöras från fasthâllningsorganen räcker det i detta fall med att öppna klämorganen 50, så att de intar läget 52 för att kroppens ändar skall glida ur fast- hållningen och inta cylindriskt läge i expanderat tillstånd.

Claims (12)

13 8202739-2 PATENTKRAV
1. Anordning for implantation av en rörformrg proteo in- nefattande en flexibel sgalvexpanderande, som protes verkande rorformig kropp (1) samt organ (3B,42) for att minska eller dka kroppens (1) diameter under förlängning resp. förkortning av kroppen (1), varvid den rorformiga kroppen (1) ar sammansatt av ett flertal enskilda styva man flexibla trådar (2,3 etc; 2a,3a etc.), av vilka var och en etracker i akruvlinjeepiral med krop- pens centrumlinge (7) eom gemensam axel, varvid ett antal trådar (2,3 etc.) med samma ekruvriktning men axiellt forekgutna 1 for- hallande till varandra koraande motor ett antal trådar (2a,3a etc.) likaaa axiellt forekgutna 1 förhållande till varandra men med motsatt akruvriktning , k ä n n a t e c k n a d darav, att namnda organ <38,42) ar anordnade så att de efter implantationen kan loagoras fran kroppen och avlaganaa fràn implantationeetallet, samt att kroppens (1) radiellt expanderade laga i huvudsak motsvarar obelastat tillstànd hos i kroppen ingående trådar (2,3 etc; 2a,3a etc.). '
2. Anordning enligt krav 1, k ä n n a t e c k n a d darav, att de varandra koraande trådarna (2,3 etc.; 2a,3a etc.) ar så anordnade 1 förhållande till varandra att de bildar ett slags flatad konfiguration, varigenom kroppen <1) får battre otadga.
3. 'Anordning enligt krav 1 eller 2, I á n n e t Ä c k - n a d darav, att antalet trådar (2,3 etc.; 2a,3a etc.) i kroppen (1) ar n, dar n varierar från ca 10-50.
4. Anordning enligt krav 3, k 5 n n a t e c k n a d darav, att antalet trådar i varje akruvriktning ar å
5. Anordning enligt något av krav 1-4, I: à' n n a t e c k- n e d därav, att kroppen (1) är anordnad att inta radiellt expan- derat läge genom elastiska organ, exempelvis band (11) eller en kroppen omgivande olaatiak strumpa, vilka stracker sig axiellt lange kroppens mantelyta och ntravar efter att axiellt trycka ihop kroppen.
6. Anordning enligt något av krav 1-4, k ä n n o t o c k- n n d därav, att kroppen etravar efter att inta radiellt expan- 822739-2 14 derat lage genom att tradarna ar fixerade till varandra 1 kors- ningepunkterna.
7. Anordning enligt nagot av föregående krav, k ä n n e- t e c k n a d darav, att nämnda organ (38,42) ar anordnade att gripa kroppens (20) ändar och genom axiell förflyttning av deeea aetadkomma minskning reep. ökning av kroppens (20) diameter.
8. Anordning enligt krav 7, k ä n n a t e c k n a d av manöverorgan (26), vilka via en axialkabelliknande anordning (23) är kopplade till ett av griporganen (42) för dettae axiella för- flyttning relativt det andra griporganet (38).
9. Anordning enligt krav 7 eller 8. k ä n n e t e c k - n a d av organ(é8,4ê; 25,27), medelst vilka griporganen (38,42) kan löegöras från kroppens (20) ändar (32,33).
10. Anordning enligt nagot av föregående krav, k ä n n e- t e c k n a d av en strumpa eller ett hblje av porös väv som om- sluter kroppen (1) i ihuvudeak hela dess längd.
11. Anordning enligt nagot av föregaende krav, k ä n n o- t e c k n a d därav, att kroppen (53) vid àtminetone den ena an- den (54) ar utförd med avtagande diameter, så att den i applicerat tillstànd kan fungera som filter.
12. Anordning enligt nagot av krav 1-4, k ä n u e t a c k- n a d därav, att kroppen <1) strävar efter att inta radiellt expanderat lage genom ett i anslutning till kroppens mantelyta pà och/eller mellan trådarna anordnat material, exempelvis applicerat genom pàsprutning av en in eitu hardande plaetmasea. ~
SE8202739A 1982-04-30 1982-04-30 Anordning for implantation av en rorformig protes SE445884B (sv)

Priority Applications (17)

Application Number Priority Date Filing Date Title
SE8202739A SE445884B (sv) 1982-04-30 1982-04-30 Anordning for implantation av en rorformig protes
BR8307541A BR8307541A (pt) 1982-04-30 1983-04-11 Protese que compreende um corpo tubular expansivel ou contratil
PCT/SE1983/000131 WO1983003752A1 (en) 1982-04-30 1983-04-11 A prosthesis comprising an expansible or contractile tubular body
GB08411519A GB2135585B (en) 1982-04-30 1983-04-11 A prosthesis comprising an expansible or contractile tubular body
NL8320142A NL192600C (nl) 1982-04-30 1983-04-11 Prothese voor transluminale implantatie, omvattende een flexibel buisvormig orgaan.
AU15186/83A AU1518683A (en) 1982-04-30 1983-04-11 A prosthesis comprising an expansible or contractile tubular body
JP58501556A JPS59500652A (ja) 1982-04-30 1983-04-11 伸縮可能な管状本体を備えた人工器官
DE19833342798 DE3342798T1 (de) 1982-04-30 1983-04-11 Prothese mit einem dehnbaren oder zusammenziehbaren rohrförmigen Körper
CH6701/83A CH662051A5 (de) 1982-04-30 1983-04-11 Netzschlauchartige, flexible, transluminal implantierbare prothese.
BE0/210667A BE896616A (fr) 1982-04-30 1983-04-29 Prothese comprenant un corps tubulaire dilatable ou contractable et son precede d'implantation.
FR838307145A FR2525896B1 (fr) 1982-04-30 1983-04-29 Prothese comprenant un corps tubulaire dilatable ou contractable et son procede d'implantation
CA000427014A CA1239755A (en) 1982-04-30 1983-04-29 Prosthesis comprising an expansible or contractile tubular body
IT20864/83A IT1169405B (it) 1982-04-30 1983-04-29 Protesi comprendente un corpo tubolare espansibile e contraibile
US06571549 US4655771B1 (en) 1982-04-30 1983-12-07 Prosthesis comprising an expansible or contractile tubular body
DK605483A DK159368B3 (da) 1982-04-30 1983-12-29 Transluminalt implanterbar protese med et flexibelt, slangeformet proteselegeme
US07330975 US4954126B1 (en) 1982-04-30 1989-03-28 Prosthesis comprising an expansible or contractile tubular body
NL9700006A NL192972C (nl) 1982-04-30 1997-06-02 Prothese voor transluminale implantatie, omvattende een flexibel buisvormig orgaan.

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CH (1) CH662051A5 (sv)
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NL192600B (nl) 1997-07-01
DE3342798T1 (de) 1985-01-10
JPS59500652A (ja) 1984-04-19
IT1169405B (it) 1987-05-27
BE896616A (fr) 1983-08-16
SE8202739L (sv) 1983-10-31
CA1239755A (en) 1988-08-02
NL8320142A (nl) 1984-08-01
CH662051A5 (de) 1987-09-15
NL192600C (nl) 1997-11-04
DE3342798C2 (sv) 1992-10-08
IT8320864A1 (it) 1984-10-29
DK605483A (da) 1983-12-29
FR2525896B1 (fr) 1990-11-30
US4655771B1 (en) 1996-09-10
AU1518683A (en) 1983-11-21
US4954126A (en) 1990-09-04
DK159368B3 (da) 2002-02-04
DK159368B (da) 1990-10-08
DK605483D0 (da) 1983-12-29
WO1983003752A1 (en) 1983-11-10
JPH0447575B2 (sv) 1992-08-04
DK159368C (da) 1991-04-22
GB8411519D0 (en) 1984-06-13
GB2135585A (en) 1984-09-05
US4954126B1 (en) 1996-05-28
US4655771A (en) 1987-04-07
IT8320864A0 (it) 1983-04-29
GB2135585B (en) 1986-03-05
FR2525896A1 (fr) 1983-11-04

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