WO2002055120B1 - Encapsulated radiopaque markers - Google Patents

Encapsulated radiopaque markers

Info

Publication number
WO2002055120B1
WO2002055120B1 PCT/US2002/000784 US0200784W WO02055120B1 WO 2002055120 B1 WO2002055120 B1 WO 2002055120B1 US 0200784 W US0200784 W US 0200784W WO 02055120 B1 WO02055120 B1 WO 02055120B1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
radiopaque
graft structure
layer
endoluminal graft
Prior art date
Application number
PCT/US2002/000784
Other languages
French (fr)
Other versions
WO2002055120A2 (en
WO2002055120A8 (en
WO2002055120A3 (en
Inventor
Edwin Tarun
Roberta L Druyor-Sanchez
Original Assignee
Impra Inc A Subsidiary Of C R
Edwin Tarun
Roberta L Druyor-Sanchez
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Impra Inc A Subsidiary Of C R, Edwin Tarun, Roberta L Druyor-Sanchez filed Critical Impra Inc A Subsidiary Of C R
Priority to AU2002243511A priority Critical patent/AU2002243511A1/en
Publication of WO2002055120A2 publication Critical patent/WO2002055120A2/en
Publication of WO2002055120A8 publication Critical patent/WO2002055120A8/en
Publication of WO2002055120A3 publication Critical patent/WO2002055120A3/en
Publication of WO2002055120B1 publication Critical patent/WO2002055120B1/en

Links

Classifications

    • 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
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • 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
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Abstract

A radiopaque marker that is incorporated into an implantable biocompatible device for precise imaging as the device is delivered and deployed within a body vessel. The radiopaque marker can take on a variety of forms which can be excised from a thin foil made of radiopaque metal or from an ePTFE sheet that has been coated on one or both surfaces with a radiopaque metal. The radiopaque markers, in forms such as rings, strips, disks, rectangles or spheres are encapsulated or contained within the implantable device to prevent the radiopaque metal from dissolving or escaping into the blood stream. Strategic placement of the radiopaque markers at each end of the implantable device enables the physician to fluoroscopically view its exact location prior to deployment and in subsequent follow-up examinations.

Claims

AMENDED CLAIMS[received by the International Bureau on 5 December 2002 (05.12.02); original claims 1 -17 replaced by new claims 1 -25 (4 pages)]We Claim:
1. An endoluminal graft structure with enhanced fluoroscopic visualization, comprising a first expanded polytetrafluoroethylene tube having an inner and an outer surface and a second expanded polytetrafluoroethylene tube having an inner and an outer surface, said second tube being positioned over said first tube, wherein at least a portion of said inner surface of said second tube is in contact with said outer surface of said first tube, and wherein at least one of said inner surface of said second tube and said outer surface of said first tube comprises a layer of radiopaque material on at least a portion thereof, said layer being of sufficient thickness or density to be viewed fluoroscopically when said graft structure is implanted within a patient, said layer being completely contained between said first tube and said second tube.
2. The endoluminal graft structure according to Claim 1, wherein said layer of radiopaque material is selected from the group consisting of gold, platinum, iridium, palladium, rhodium, titanium, tungsten and barium sulfate.
3. The endoluminal graft structure according to Claim 1, wherein said layer of radiopaque material comprises a liquid or paste.
4. The endoluminal graft structure according to Claim 3, wherein said liquid or paste comprises barium sulfate.
5. The endoluminal graft structure according to Claim 1, wherein said layer of radiopaque material has a thickness of greater than 0.004 in.
6. The endoluminal graft structure according to Claim 1, wherein each of said outer surface of said first tube and said inner surface of said second tube comprises a layer of radiopaque material on at least a portion thereof.
7. The endoluminal graft structure according to Claim 1, further comprising a support structure positioned between said first and second tubes.
8. A method for making an endoluminal graft structure with enhanced fluoroscopic visualization, said graft structure comprising first and second expanded polytetrafluoroethylene tubes, each of said tubes having an inner and an outer surface, wherein said second tube has a diameter greater than said first tube, comprising the steps of: depositing a layer of radiopaque material on at least one of said outer surface of said first tube and said inner surface of said second tube on at least a portion thereof, wherein said layer is of sufficient thickness or density to be viewed fluoroscopically when said endoluminal graft structure is implanted within a patient; positioning said second tube over said first tube; and adhering said first tube to said second tube along at least a portion thereof, wherein said layer of radiopaque material is completely captured therebetween.
9. The method according to claim 8, further comprising the step of positioning a support structure between said first and second tubes.
10. The method according to claim 8, wherein said depositing step further comprises depositing a layer of radiopaque material on each of said outer surface of said first tube and said inner surface of said second tube.
11. The method according to claim 8, wherein said depositing step comprises using a process selected from the group consisting of electron beam evaporation, sputtering and metal plating.
18
12. An endoluminal graft structure with enhanced fluoroscopic visualization, comprising a first expanded polytetrafluoroethylene tube and a second expanded polytetrafluoroethylene tube, said second tube being positioned over said first tube, and at least one radiopaque member comprising a shaped expanded polytetrafluoroethylene article having a layer of radiopaque material deposited thereon positioned between said first and second tubes.
13. The endoluminal graft structure according to Claim 12, wherein said layer of radiopaque material is selected from the group consisting of gold, platinum, iridium, palladium, rhodium, titanium, tungsten and barium sulfate.
14. The endoluminal graft structure according to Claim 12, wherein said layer of radiopaque material has a thickness of greater than 0.004 in.
15. The endoluminal graft structure according to Claim 12, wherein said radiopaque member has a form selected from the group consisting of a ring, a strip, a disk and a sphere.
16. The endoluminal graft structure according to Claim 12, further comprising a support structure positioned between said first and second tubes.
17. The endoluminal graft structure according to Claim 16, wherein said support structure has a length longer than said first and second tubes.
18. The endoluminal graft structure according to Claim 17, wherein said first tube and said second tube have a substantially similar length and opposing terminal ends, and wherein said radiopaque member is positioned at one of said opposing terminal ends.
19. The endoluminal graft structure according to Claim 18, further comprising a plurality of radiopaque members comprising shaped expanded polytetrafluoroethylene articles having a layer of radiopaque material
19 deposited thereon, wherein said radiopaque members are positioned at both of said opposing terminal ends of said first and second tubes.
20. The endoluminal graft structure according to Claim 16, wherein said first expanded polytetrafluoroethylene tube is unsintered and wherein said at least one radiopaque member comprises a plurality of radiopaque strips of expanded polytetrafluoroethylene positioned circumferentially around said first expanded polytetrafluoroethylene tube.
21. The endoluminal graft structure according to Claim 12, wherein said layer of radiopaque material comprises a liquid or paste.
22. The endoluminal graft structure according to Claim 21, wherein said liquid or paste comprises barium sulfate.
23. The endoluminal graft structure according to Claim 12, wherein said first expanded polytetrafluoroethylene tube is unsintered and further comprising a plurality of strips of expanded polytetrafluoroethylene positioned circumferentially around said first expanded polytetrafluoroethylene tube.
24. A radiopaque locating marker, comprising a shaped article made of non-porous material in the form of a sphere, wherein said sphere contains within it a radiopaque liquid or paste.
25. The radiopaque locating marker according to claim 24, wherein said radiopaque liquid or paste comprises barium sulfate.
20
PCT/US2002/000784 2001-01-12 2002-01-10 Encapsulated radiopaque markers WO2002055120A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002243511A AU2002243511A1 (en) 2001-01-12 2002-01-10 Encapsulated radiopaque markers

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/760,254 US20020095205A1 (en) 2001-01-12 2001-01-12 Encapsulated radiopaque markers
US09/760,254 2001-01-12

Publications (4)

Publication Number Publication Date
WO2002055120A2 WO2002055120A2 (en) 2002-07-18
WO2002055120A8 WO2002055120A8 (en) 2002-09-26
WO2002055120A3 WO2002055120A3 (en) 2002-12-12
WO2002055120B1 true WO2002055120B1 (en) 2003-03-06

Family

ID=25058541

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/000784 WO2002055120A2 (en) 2001-01-12 2002-01-10 Encapsulated radiopaque markers

Country Status (3)

Country Link
US (1) US20020095205A1 (en)
AU (1) AU2002243511A1 (en)
WO (1) WO2002055120A2 (en)

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Also Published As

Publication number Publication date
US20020095205A1 (en) 2002-07-18
WO2002055120A2 (en) 2002-07-18
WO2002055120A8 (en) 2002-09-26
WO2002055120A3 (en) 2002-12-12
AU2002243511A1 (en) 2002-07-24

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