CA2390938A1 - Encapsulated stent preform - Google Patents

Encapsulated stent preform Download PDF

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Publication number
CA2390938A1
CA2390938A1 CA002390938A CA2390938A CA2390938A1 CA 2390938 A1 CA2390938 A1 CA 2390938A1 CA 002390938 A CA002390938 A CA 002390938A CA 2390938 A CA2390938 A CA 2390938A CA 2390938 A1 CA2390938 A1 CA 2390938A1
Authority
CA
Canada
Prior art keywords
core
outer sheath
stent preform
elongated
polymer
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002390938A
Other languages
French (fr)
Other versions
CA2390938C (en
Inventor
Swaminathan Jayaraman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vascular Concepts Holdings Ltd
Original Assignee
Swaminathan Jayaraman
Iowa-India Investments Company, Limited
Vascular Concepts Holdings Limited
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 Swaminathan Jayaraman, Iowa-India Investments Company, Limited, Vascular Concepts Holdings Limited filed Critical Swaminathan Jayaraman
Publication of CA2390938A1 publication Critical patent/CA2390938A1/en
Application granted granted Critical
Publication of CA2390938C publication Critical patent/CA2390938C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61F2/82—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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Abstract

The invention relates to a stent preform for implantation in a body lumen. The stent preform includes an elongated metal core having first and second core ends, a contact surface, and a solid cross-section, and a hollow outer sheath made of a biocompatible polymer and having first and second sheath ends, caps disposed on the sheath ends, and an interior surface.
The outer sheath surrounds and contacts the contact surface of the core to prevent the core from directly contacting the body lumen. In another embodiment, the biocompatible polymer of the outer sheath is formed of a heat-shrinkable polymer material, and the elongated core is formed of a shape-memory alloy.
In another embodiment, the outer sheath is formed from a polymer tape.

Claims (29)

THE CLAIMS

What is claimed is:
1. A stent preform (10; 40; 60; 72) for implantation in a body lumen comprising:
an elongated wireform metal core (12; 42; 62) having first and second core ends (16; 18), a contact surface (14), and a solid cross-section; and a hollow outer sheath (20; 44) made of a biocompatible polymer and having first and second sheath ends (22; 24), caps (26; 28) disposed on the sheath ends (22; 24), and an interior surface (30), wherein the outer sheath (20; 44) surrounds and contacts the contact surface (14) of the core (12; 42; 62) and the caps (26; 28) surround the core ends (16; 18) to prevent the core (12; 42; 62) from directly contacting the body lumen.
2. The stent preform (10; 40; 60; 72) of claim 1, wherein the elongated core (12;
42; 62) is expandable, and the outer sheath (20; 44) is capable of deforming to compensate for dimensional changes in the cross-section of the expanded core (12; 42;
62).
3. The stent preform (10; 40; 60; 72) of claim 2, wherein the cross-section of the core (12; 42; 62) is substantially cylindrical.
4. The stent preform (10; 40; 60; 72) of claim 1, wherein the biocompatible polymer of the outer sheath (20; 44) is formed of a heat-shrinkable polymer material.
5. The stent preform (10; 40; 60; 72) of claim 1, wherein the outer sheath (20;
44) with caps (26; 28) is formed from a polymer tape (64).
6. The stent preform (10; 40; 60; 72) of claim 2, wherein the elongated core (12;
42; 62) is formed of a shape-memory alloy.
7. The stent preform (10; 40; 60; 72) of claim 2, wherein the outer sheath (20;
44) is made of a polymer film having a thickness between about 0,1 micron and about 5 millimeters.
8. The stent preform (10; 40; 60; 72) of claim 1, wherein the sheath caps (26;
28) have a generally rounded contour to minimize stress concentration along the walls of the lumen.
9. The stent preform (10; 40; 60; 72) of claim 1, which further comprises a cover of a biological or synthetic coating (34) to minimize interference of the scent preform (10; 40;
60; 72) with normal blood function.
10. The stent preform (10; 40; 60; 72) of claim 9, wherein the coating (34) is an anticoagulant selected from the group of heparin, hirudin, coumadin, tichlopidiene, and chlopidogrel.
11. The stent preform (10; 40; 60; 72) of claim 9, wherein the coating (34) is disposed in micropores in the outer sheath (20; 44), allowing controlled release of constituents of the coating.
12. A stent preform (10; 40; 60; 72) for implantation in a body lumen comprising:
an elongated metal core (12; 42; 62) having first and second core ends (16;
18), a contact surface (14), and a solid cross-section;
a hollow outer sheath (20; 44) made of a biocompatible polymer and having first and second sheath ends (22; 24), caps (26; 28) disposed on the sheath ends (22; 24), and an interior surface (30); and at least one intermediate sleeve (32) disposed between the outer sheath (20;
44) and the core (12; 42; 62), wherein the outer sheath (20;44) surrounds the intermediate sleeve (32) and contact surface (14) of the core (12; 42: 62) to prevent the sleeve (32) and core (12; 42; 62) from directly contacting the body lumen.
13. The stent preform (10; 40; 60; 72) of claim 12, wherein the at least one intermediate sleeve (32) comprises a lubricious lining (46), the core (12; 42;
62) and the lining (46) forming a composite body that is configured and dimensioned to be slidably received by the outer sheath (20; 44).
l4. The stent preform (10; 40; 60; 72) of claim 12, wherein the at least one intermediate sleeve (32) comprises a lubricious lining (46), the outer sheath (20; 44) and the lining (46) forming a composite body that as configured and dimensioned to be slidably received by the core (12; 42; 62).
15. The stent preform (10; 40; 60; 72) of claim 12, wherein the at least one intermediate sleeve (32) comprises a lubricious lining (46).
16. A filamentary member (10; 40; 60; 72) for implantation inside a body lumen comprising:
a rigid, elongated wireform inner filament (12; 42; 62) having fast and second filament ends (16; 18); and an outer sheath (20; 44) having first and second sheath ends (22; 24), wherein the outer sheath (20; 44) is made of a biocompatible polymer, and wherein the outer sheath (20; 44) completely encapsulates and contacts the inner filament (12; 42; 62) and first and second filament ends (16; 18) to prevent the inner filament (12;
42; 62) from directly contacting a wall inside a body lumen.
17. The filamentary member (10; 40; 60; 72) of claim 16, wherein the inner filament (12; 42; 62) is made of a plurality of woven fibers.
18. The filamentary member (10; 40; 60; 72) of claim 16, wherein the inner filament (12; 42; 62) is made from carbon fiber, kevlar, or glass fiber.
19. A method of making a stent preform (10; 40; 64; 72) comprising the steps of providing an elongated wireform core (12; 42; 62) with first and second ends (16; 18);

completely encapsulating and surrounding the core (12; 42; 62) and ends (16;
18) with a polymer jacket (20; 44) to create a composite;
heat treating the composite to promote bonding of the core (12; 42; 62) and jacket (20;
44); and bending the composite to a desired shape.
20. The method of claim 19, wherein the elongated core (12; 42; 62) is made of metal.
21. The method of claim 20, wherein the metal is a shape-memory alloy.
22. The method of claim 21, wherein the polymer jacket (20; 44) is formed of a biocompatible polymer.
23. The method of claim 22, wherein the elongated core (12; 42; 62) is expandable, and the polymer jacket (20; 44) is capable of deforming to compensate for dimensional changes in the cross-section of the expanded core (12; 42; 62).
24. The method of claim 21, further comprising the step of heat treating the elongated core (12; 42; 62) prior to encapsulating the core (12; 42; 62) with a polymer jacket (20; 44).
25. The method of claim 21, wherein the polymer jacket (20; 44) is formed of a tape (64) of a biocompatible polymer.
26. A method of making a stent preform (10; 40; 60; 72) comprising the steps of:
providing an elongated wireform metal care (12; 42; 62) with first and second ends (16; 18);
completely encapsulating and surrounding the core (12; 42; 62) and ends (16;
18) with a polymer tape (64) to create a composite; and bending the composite to a desired shape.
27. The method of claim 26, wherein the tape (64) is a vascular fabric.
28. A method of making a stent preform (10; 40; 60; 72) for implantation inside a body lumen comprising the steps of:
providing an elongated wireform core (12; 42; 62) with first and second ends (16; 18), the core (12; 42; 62) being made of a shape-memory material;
completely encapsulating the core (12; 42; 62) and ends (16;18) with a biocompatible fabric to create a composite; and bending the composite to a desired shape.
29. A method of making a stent preform (10; 40; 60; 72) comprising the steps of:
providing an elongated core (12; 42; 62) made of a shape-memory material;
completely encapsulating the core (12; 42; 62) with a biocompatible fabric to create a composite;
bending the composite to a desired shape; and providing at least one intermediate sleeve (32) disposed between the biocompatible fabric and the core (12; 42; 62).
CA2390938A 1999-11-16 2000-11-16 Encapsulated stent preform Expired - Fee Related CA2390938C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/440,926 US6475235B1 (en) 1999-11-16 1999-11-16 Encapsulated stent preform
US09/440,926 1999-11-16
PCT/GB2000/004362 WO2001035859A1 (en) 1999-11-16 2000-11-16 Encapsulated stent preform

Publications (2)

Publication Number Publication Date
CA2390938A1 true CA2390938A1 (en) 2001-05-25
CA2390938C CA2390938C (en) 2010-11-16

Family

ID=23750765

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2390938A Expired - Fee Related CA2390938C (en) 1999-11-16 2000-11-16 Encapsulated stent preform

Country Status (10)

Country Link
US (2) US6475235B1 (en)
EP (1) EP1229862B1 (en)
JP (1) JP2003513746A (en)
AT (1) ATE353607T1 (en)
AU (1) AU780715B2 (en)
CA (1) CA2390938C (en)
DE (1) DE60033417T2 (en)
HK (1) HK1045093A1 (en)
IL (2) IL149609A0 (en)
WO (1) WO2001035859A1 (en)

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EP1229862B1 (en) 2007-02-14
CA2390938C (en) 2010-11-16
IL149609A (en) 2007-03-08
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HK1045093A1 (en) 2002-11-15
US6746478B2 (en) 2004-06-08
WO2001035859A1 (en) 2001-05-25
EP1229862A1 (en) 2002-08-14
US20030055479A1 (en) 2003-03-20
JP2003513746A (en) 2003-04-15
US6475235B1 (en) 2002-11-05
DE60033417T2 (en) 2007-11-29
DE60033417D1 (en) 2007-03-29

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