CA2469744A1 - Layered stent-graft and methods of making the same - Google Patents

Layered stent-graft and methods of making the same Download PDF

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Publication number
CA2469744A1
CA2469744A1 CA002469744A CA2469744A CA2469744A1 CA 2469744 A1 CA2469744 A1 CA 2469744A1 CA 002469744 A CA002469744 A CA 002469744A CA 2469744 A CA2469744 A CA 2469744A CA 2469744 A1 CA2469744 A1 CA 2469744A1
Authority
CA
Canada
Prior art keywords
layer
porous
graft
solvent
stent
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
CA002469744A
Other languages
French (fr)
Other versions
CA2469744C (en
Inventor
Ken A. Holloway
Christofer T. Christoforou
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.)
Thoratec LLC
Original Assignee
Thoratec Corporation
Ken A. Holloway
Christofer T. Christoforou
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 Thoratec Corporation, Ken A. Holloway, Christofer T. Christoforou filed Critical Thoratec Corporation
Publication of CA2469744A1 publication Critical patent/CA2469744A1/en
Application granted granted Critical
Publication of CA2469744C publication Critical patent/CA2469744C/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
    • A61F2/02—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
    • A61F2/89—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 comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Abstract

A stent-graft (10) made of at least three concentric layers (12, 14, 16) is disclosed. The inner and outer layers (16, 12) can be porous. The middle layer (14) can be non-porous and encompasses a stent (18).

Claims (21)

1. A stent-graft comprising:
a porous first layer for making contact with tissue of a vessel wall;
a non-porous layer attached to the porous first layer;
a frame encapsulated by the non-porous layer; and a porous second layer, wherein the non-porous layer is between the porous first layer and the porous second layer.
2. The stent-graft of Claim 1, wherein the porous first layer has a void-to-volume ratio of about 40% to about 90%.
3. The stent-graft of Claim 1, wherein the porous first layer has a void-to-volume ratio of about 70% to about 80%.
4. The stent-graft of Claim 1, wherein the non-porous layer has a void-to-volume ratio of about less than 5%.
5. The stent-graft of Claim 1, wherein the non-porous layer has a void-to-volume ratio of about less than 1%.
6. The stent-graft of Claim 1, wherein the porous second layer has a void-to-volume ratio of about 40% to about 90%.
7. The stent-graft of Claim 1, wherein the porous second layer has a void-to-volume ratio of about 65% to about 80%.
8. The stent-graft of Claim 1, wherein pores of the porous first and second layers have an average pore diameter of about 1 micron to about 400 microns.
9. The stent-graft of Claim 1, wherein the frame comprises a plurality of interconnected struts separated by gaps.
10. The stent-graft of Claim 1, wherein the frame comprises a plurality of rings separated at a distance from one another.
11. The stent-graft of Claim 1, wherein the porous first or second layer comprises a plurality of sub-layers, wherein each sub-layer has a different porosity.
12. A method of manufacturing a stent-graft comprising:
(a) forming a porous first layer on a mandrel;
(b) forming a second layer on the porous first layer;
(c) positioning a frame on the second layer;
(d) increasing the thickness of the second layer to substantially or completely encapsulate the frame in the second layer; and (e) forming a porous third layer on the second layer.
13. The method of Claim 12, wherein the act of forming the porous first layer comprises applying a composition comprising a solvent, a polymer dissolved in the solvent, and water-soluble particles added thereto to the mandrel and removing the solvent and the water-soluble particles from the polymer.
14. The method of Claim 12, wherein the act of forming the third layer comprises applying a composition comprising a solvent, a polymer dissolved in the solvent, and water-soluble particles added thereto to the second layer and removing the solvent and water-soluble particles from the polymer.
15. The method of Claim 12, wherein the porous first and third layers have a void-to-volume ratio of about 40% to about 90%.
16. The method of Claim 12, wherein the second layer has a void-to-volume ration of less than about 5%.
17. The method of Claim 12, wherein the frame comprises a plurality of interconnected struts.
18. The method of Claim 12, wherein the frame comprises a plurality of rings separated at a distance form one another.
19. The method of Claim 12, wherein the second layer does not include any gaped regions about the area where the second layer is in contact with the surfaces of the frame.
20. The method of Claim 12, wherein the acts of (a) and (b) comprise:
(a) applying the first composition comprising a first polymer and a first solvent to the mandrel and removing essentially most of the first solvent from the composition to solidify the first polymer on the mandrel but allowing the surface of the first polymer to be in a semi-sold state;
(b) applying the second composition comprising a second polymer and a second solvent to the first polymer and removing the first and second solvents to form the first layer and the second layer attached to the first layer.
21. The method of Claim 12, wherein the acts of (b) through (e) comprise:
(a) applying a first composition comprising a first polymer and a first solvent to the first layer and removing essentially all of the first solvent from the composition to solidify the first polymer;
(b) positioning the frame on the second layer;
(c) reapplying the first composition to the second layer and the frame and removing the first solvent from the composition to increase the thickness of the second layer;
(d) repeating act (c) if needed until the scaffolding structure is substantially or completely encapsulated by the second layer; and (e) applying a second composition, comprising a second polymer and a second solvent to the second layer to form the third layer.
CA2469744A 2001-12-14 2002-12-06 Layered stent-graft and methods of making the same Expired - Fee Related CA2469744C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/017,693 2001-12-14
US10/017,693 US6752826B2 (en) 2001-12-14 2001-12-14 Layered stent-graft and methods of making the same
PCT/US2002/038940 WO2003051233A1 (en) 2001-12-14 2002-12-06 Layered stent-graft and methods of making the same

Publications (2)

Publication Number Publication Date
CA2469744A1 true CA2469744A1 (en) 2003-06-26
CA2469744C CA2469744C (en) 2010-04-13

Family

ID=21784051

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2469744A Expired - Fee Related CA2469744C (en) 2001-12-14 2002-12-06 Layered stent-graft and methods of making the same

Country Status (6)

Country Link
US (1) US6752826B2 (en)
EP (1) EP1460972B1 (en)
JP (1) JP4411431B2 (en)
AU (1) AU2002353068B2 (en)
CA (1) CA2469744C (en)
WO (1) WO2003051233A1 (en)

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US20030114917A1 (en) 2003-06-19
EP1460972B1 (en) 2015-06-17
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JP2005511242A (en) 2005-04-28
AU2002353068B2 (en) 2008-06-05
WO2003051233A1 (en) 2003-06-26
US6752826B2 (en) 2004-06-22
EP1460972A4 (en) 2008-05-21
JP4411431B2 (en) 2010-02-10
CA2469744C (en) 2010-04-13

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