WO2001032099B1 - Stretchable anti-buckling coiled-sheet stent - Google Patents

Stretchable anti-buckling coiled-sheet stent

Info

Publication number
WO2001032099B1
WO2001032099B1 PCT/US2000/028944 US0028944W WO0132099B1 WO 2001032099 B1 WO2001032099 B1 WO 2001032099B1 US 0028944 W US0028944 W US 0028944W WO 0132099 B1 WO0132099 B1 WO 0132099B1
Authority
WO
WIPO (PCT)
Prior art keywords
stretchable
sheet
cells
stent
coiled
Prior art date
Application number
PCT/US2000/028944
Other languages
French (fr)
Other versions
WO2001032099A3 (en
WO2001032099A2 (en
Inventor
Farhad Khosravi
Himanshu N Patel
Original Assignee
Endotex Interventional Sys Inc
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 Endotex Interventional Sys Inc filed Critical Endotex Interventional Sys Inc
Priority to AT00973677T priority Critical patent/ATE299361T1/en
Priority to JP2001534311A priority patent/JP2003512887A/en
Priority to DE60021274T priority patent/DE60021274T2/en
Priority to EP00973677A priority patent/EP1225844B1/en
Priority to CA002387069A priority patent/CA2387069A1/en
Publication of WO2001032099A2 publication Critical patent/WO2001032099A2/en
Publication of WO2001032099A3 publication Critical patent/WO2001032099A3/en
Publication of WO2001032099B1 publication Critical patent/WO2001032099B1/en

Links

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
    • A61F2/92Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • 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
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2230/0054V-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
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

Abstract

A stretchable coiled-sheet stent includes a coiled-up sheet having overlapping inner and outer longitudinal sections that is expandable between contracted and enlarged conditions, and a plurality of stretchable elements formed in the coiled-up sheet which are expandable between unstretched and stretched conditions. The coiled-up sheet is preferably formed from a temperature-based shape memory material, such as Nitinol, and at least one of the unstretched and stretched shapes is programmed into the shape memory. For example, the stretchable elements may be initially formed in the stretched shape, and the sheet heat treated to program the stretched shape into the shape memory. After cooling, the stretchable elements may be constrained in the unstretched shape for delivery. Alternatively, the stretchable elements may be formed in the unstretched shape and plastically deformed to their stretched shape, and the sheet may be heat treated to program the stretched shape into the shape memory. Upon cooling, the stretchable elements may return to their unstretched shape. The coiled-sheet stent is delivered in its contracted condition with the stretchable elements in the unstretched shape. The stent is introduced into a blood vessel and advanced to a target location, exposing the stent to the body temperature and activating the shape memory to bias the stretchable elements towards the stretched shape. The stent is deployed, at least partially expanding towards the enlarged condition due to the bias of the stretchable elements towards the stretched shape.

Claims

34AMENDED CLAIMS[received by the International Bureau on 26 June 2001 (26.06.01); original claims 1-50 replaced by amended claims 1-38 (7 pages)]
1. A stretchable stent, comprising: a coiled-up sheet having overlapping inner and outer longitudinal sections extending generally parallel to a longitudinal axis thereof, and defining a periphery, the coiled-up sheet being biased to unwind from a contracted condition towards one or more enlarged conditions; and a plurality of stretchable cells formed in the coiled- up sheet, the stretchable cells being biased to expand about he periphery from an unstretched condition to facilitate placement m a delivery device in the contracted condition towards a stretched condition to facilitate expansion of the coiled-up sheet to the one or more enlarged conditions upon deployment from the delivery device.
2 . The stretchable stent of claim 1, further comprising a plurality of locking elements extending from the inner longitudinal section for engaging openings m the outer longitudinal section to selectively secure the coiled- up sheet in the one or more enlarged conditions.
3. The stretchable stent of claim 1 or 2 , wherein the stretchable cells are configured to at least partially invert upon themselves m the contracted condition, thereby allowing the stretchable cells to expand to the one or more enlarged conditions with no longitudinal foreshortening.
4. The stretchable stent of claim 1, 2, or 3 , wherein the stretchable ceils are biased to assume the stret.ch.ed condition, thereoy at least partially biasing the coiled-up sheet to radially expand from the contracted condition towards the one or more enlarged conditions .
5. The stretchable stent of any of claims 1-4, wherein the coiled-up sheet comprises a material having a temperature-based shape memory, whereby the stretchable cells are plastically compressible towards the unstretched condition when exposed to a first temperature and biased towards the stretched condition when exposed to a second temperature .
6. The stretchable stent of claim 5, wherein the second temperature is at or above body temperature.
7. The stretchable stent of claim 5, wherein the first temperature is at or below about 25 degrees Celsius.
8. The stretchable stent of claim 5 , wherein the coiled-up sheet comprises Nitinol.
9. The stretchable stent of claim 8, wherein the Nitmol is in its martensitic phase at the first temperature and in its austenitic phase at the second temperature.
10. The stretchable stent of any preceding claim, wherein the coiled-up sheet further comprises a nondeformable region.
11. The stretchable stent of claim 11, wherein the nondeformable region comprises a rigid lattice-like structure . 36
12. The stretchable stent of any of claims 1-9, wherein the entire coiled-up sheet has stretchable cells formed therein.
13. The stretchable stent of any preceding claim, wherein the stretchable cells define a longitudinal stretchable region extending between first and second ends of the coiled-up sheet.
14. The stretchable stent of any preceding claim, wherein the stretchable cells define a stretchable crowning end on one end of the coiled-up sheet .
15. The stretchable stent of claim i or 2 , wherein the stretchable cells having a shape memory biased to expand about the periphery from an unstretched condition towards a stretched condition when exposed to a predetermined temperature .
16. The stretchable stent of claim 15, wherein the stretchable cells are biased to assume the stretched condition when exposed to a temperature at or above body temperature .
17. The stretchable stent of claim 15 or 16, wherein the coiled-up sheet comprises Nitinol.
18. The stretchable stent of claim 17, wherein the stretchable cells comprise austenite at or above body teπraerature . 37
19. The stretchable stent of claim 17 or 18, wherein the stretchable cells comprise martensite at or below about 25 degrees Celsius.
20. The stretchable stent of any preceding claim, wherein the stretchable cells comprise a multi-cellular structure of diamond-shaped cells capable of assuming unstretched and stretched conditions.
21. The stretchable stent of claim 20, wherein the diamond-shaped cells comprise peripheral apices extending generally along the peripheral dimension, the peripheral apices having peripherally extending nipples for reducing longitudinal foreshortening when the diamond-shaped cells are directed from the unstretched condition to the stretched condition.
22. The stretchable stent of claim 20, wherein the diamond-shaped cells are partially invertable to assume the unstretched condition.
23. The stretchable stent of any of claims 1-19, wherein the stretchable cells define a ulti-cellular structure comprising a plurality of zigzag elements extending about the periphery of the coiled-up sheet, and a plurality of longitudinal elements intersecting the zigzag elements .
24. The stretchable stent of any of claims 1-19, wherein each stretchable cell comprises a pair of peripherally expandable wing-like elements extending generally parallel to the longitudinal axis. 38
25. The stretchable stent of claim 24, wherein the stretchable cells define a multi -cellular structure with peripherally adjacent stretchable cells being connected at a point intermediate the pair of wing-like elements.
26. A method for making a coiled-sheet stent, the method comprising the steps of: providing a substantially flat sheet defining a length and a width; forming a plurality of stretchable cells in the sheet, the stretchable cells being expandable along the width of the sheet between an unstretched condition and a stretched condition; and rolling the flat sheet about the width into a coiled-up sheet having overlapping inner and outer longitudinal sections .
27. The method of claim 26, wherein the sheet comprises a shape memory material, and wherein the stretched shape is programmed into the shape memory material during the step of forming the stretchable cells.
28. The method of claim 27, wherein the step of forming the stretchable cells comprises the steps of: forming the stretchable cells in the sheet in the stretched shape; and heat treating the sheet to program the stretched shape into the shape memory material . 39
29- The method of claim 28, comprising the additional step of constraining the stretchable cells in the unstretched shape after the heat treating step.
30. The method of any of claims 27-29, wherein the shape memory material comprises Nitinol, and wherein the Nitinol comprises austenite during the heat treating step.
31. The method of claim 30, wherein the sheet is heated to a temperature of at least about body temperature, the temperature being sufficiently high such that the Nitinol substantially completes austenitic transforma ion.
32. The method of claim 30, comprising the additional step of cooling the sheet after the heat treating step, the Nitinol comprising martensite after the cooling step.
33. The method of claim 31 or 32, wherein the sheet is cooled to a temperature of about 25 degrees Celsius or less, the temperature being sufficiently low such that the Nitinol substantially completes martensitic transformation.
34. The method of claim 32 or 33, comprising the additional step of plastically deforming the stretchable cells to their unstretched shape after the cooling step.
35. The method of claim 27, wherein the step of forming the stretchable cells comprises the steps of: forming the stretchable cells in the 3heet in their unstretched shape; plastically deforming the stretchable cells to their stretched shape; and 40
heat treating the sheet to program the stretched shape into the shape memory material .
36. The method of claim 35, comprising the additional step of cooling the sheet after the heat treating step, thereby causing the stretchable cells to return to their unstretched shape.
37. The method of any of claims 26-36, wherein the stretchable cells are formed in the sheet by chemical etching, laser cutting or punching.
38. The method of any of claims 26-37, comprising the additional step of forming a plurality of locking elements along an edge of the sheet extending along the length thereof .
PCT/US2000/028944 1999-10-25 2000-10-18 Stretchable anti-buckling coiled-sheet stent WO2001032099A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AT00973677T ATE299361T1 (en) 1999-10-25 2000-10-18 STRETCHY, NON-KINKING, WRAPPED STENT
JP2001534311A JP2003512887A (en) 1999-10-25 2000-10-18 Stretchable buckling resistant coil sheet stent
DE60021274T DE60021274T2 (en) 1999-10-25 2000-10-18 DEANBAR, NOT KNITTING, WRAPPED STENT
EP00973677A EP1225844B1 (en) 1999-10-25 2000-10-18 Stretchable anti-buckling coiled-sheet stent
CA002387069A CA2387069A1 (en) 1999-10-25 2000-10-18 Stretchable anti-buckling coiled-sheet stent

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/427,260 US8092514B1 (en) 1998-11-16 1999-10-25 Stretchable anti-buckling coiled-sheet stent
US09/427,260 1999-10-25

Publications (3)

Publication Number Publication Date
WO2001032099A2 WO2001032099A2 (en) 2001-05-10
WO2001032099A3 WO2001032099A3 (en) 2001-09-27
WO2001032099B1 true WO2001032099B1 (en) 2001-11-29

Family

ID=23694136

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/028944 WO2001032099A2 (en) 1999-10-25 2000-10-18 Stretchable anti-buckling coiled-sheet stent

Country Status (8)

Country Link
US (1) US8092514B1 (en)
EP (2) EP1225844B1 (en)
JP (1) JP2003512887A (en)
AT (2) ATE299361T1 (en)
CA (1) CA2387069A1 (en)
DE (2) DE60045748D1 (en)
ES (1) ES2243316T3 (en)
WO (1) WO2001032099A2 (en)

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US8092514B1 (en) 2012-01-10
ATE299361T1 (en) 2005-07-15
EP1559382A3 (en) 2006-04-26
EP1559382A2 (en) 2005-08-03
WO2001032099A3 (en) 2001-09-27
JP2003512887A (en) 2003-04-08
DE60021274T2 (en) 2006-05-18
DE60045748D1 (en) 2011-04-28
DE60021274D1 (en) 2005-08-18
ATE501686T1 (en) 2011-04-15
ES2243316T3 (en) 2005-12-01
CA2387069A1 (en) 2001-05-10
WO2001032099A2 (en) 2001-05-10
EP1225844B1 (en) 2005-07-13
EP1225844A2 (en) 2002-07-31
EP1559382B1 (en) 2011-03-16

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