CA2471772A1 - Non-compliant balloon with compliant top-layer to protect coated stents during expansion - Google Patents

Non-compliant balloon with compliant top-layer to protect coated stents during expansion Download PDF

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Publication number
CA2471772A1
CA2471772A1 CA002471772A CA2471772A CA2471772A1 CA 2471772 A1 CA2471772 A1 CA 2471772A1 CA 002471772 A CA002471772 A CA 002471772A CA 2471772 A CA2471772 A CA 2471772A CA 2471772 A1 CA2471772 A1 CA 2471772A1
Authority
CA
Canada
Prior art keywords
stent
compliant
sheath
expandable
deployment assembly
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
CA002471772A
Other languages
French (fr)
Other versions
CA2471772C (en
Inventor
Jan Weber
Tim O'connor
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.)
Boston Scientific Ltd Barbados
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2471772A1 publication Critical patent/CA2471772A1/en
Application granted granted Critical
Publication of CA2471772C publication Critical patent/CA2471772C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • 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
    • A61F2002/9583Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1081Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths

Abstract

In order to minimize the potential for damage to bio-compatible and/or therapeutic-containing stent coatings, there is provided a compliant elastic sheath over layer between a non-compliant stent expansion balloon and an unexpanded stent, which is secured over the balloon with a securing crimp.
This stent deployment assembly, which is mounted on a catheter, is maneuvered through a patient's body to a desired deployment site and then inflated to expand the stent to the desired diameter. During expansion, the compliant elastic material between the stent and the non-compliant balloon prevents non-compliant balloon-induced damage to the stent's coating, as well as preventing degradation of the non-compliant balloon by, for example, stent-caused punctures. The deflated non-compliant stent expansion balloon and compliant elastic sheath are then withdrawn from the patient's body, leaving the deployed stent at the desired implantation site with its coating substantially intact.

Claims (22)

1. An expandable stent deployment assembly for stent implantation within a patient's body, comprising:
an expandable stent with a polymer coating on at least a portion of an inner surface of the stent;
a stent expansion balloon, expandable from a first configuration to a second configuration, the balloon sized to fit within the expandable stent when the balloon and the stent are unexpanded; and a compliant sheath located between the stent expansion balloon and the stent.
2. The expandable stent deployment assembly of claim 1, wherein the stent is in contact with the sheath when the stent is unexpanded.
3. The expandable stent deployment assembly of claim 2, wherein the stent is crimped over the sheath.
4. The expandable stent deployment assembly of claim 1, wherein the polymer coating comprises at least one therapeutic agent.
5. The expandable stent deployment assembly of claim 4, wherein the polymeric material comprises one of polyamide, thermoplastic polyamide, polyester, polyphenylene sulfide, and polyethylene terephthalate.
6. The expandable stent deployment assembly of claim 4, wherein the compliant sheath comprises one of Latex and silicone rubber.
7. The expandable stent deployment assembly of claim 1, wherein the compliant sheath is closed about at least one of a distal end and a proximal end of the stent expansion balloon.
8. The expandable stent deployment assembly of claim 1, wherein the compliant sheath comprises a tube, and further wherein the length of the tube is equal to or greater than the length of the stent.
9. The expandable stent deployment assembly of claim l, further comprising an adhesive located between the compliant sheath and the stent expansion balloon.
10. The expandable stent deployment assembly of claim 9, further comprising an adhesive located between a distal end of the compliant sheath and the distal end of the stent expansion balloon.
11. The expandable stent deployment assembly of claim 8, further comprising an adhesive located at at least one location between the tube and the stent expansion balloon, wherein an amount and the location of said adhesive are such that movement of the balloon relative to the sheath during stent expansion is not inhibited in a manner that permits a coating on the stent to be damaged.
12. The expandable stent deployment assembly of claim 1, further comprising a lubricant located between the compliant sheath and the stent expansion balloon.
13. The expandable stent deployment assembly of claim 1, wherein the stent is in contact with the compliant sheath over the entire length of the stent.
14. The expandable stent deployment assembly of claim 1, wherein the stent is crimped over the compliant sheath over the entire length of the stent.
15. The expandable stent deployment assembly of claim 1, wherein the stent is in contact with the compliant sheath at at least one of a distal end and a proximal end of the stent.
16. The expandable stent deployment assembly of claim l, wherein the stent is crimped over the compliant sheath at at least one of a distal end and a proximal end of the stent.
17. The expandable stent deployment assembly of claim 1, further comprising a lubricant located between the compliant sheath and the stent expansion balloon.
18. The expandable stent deployment assembly of claim l, wherein the compliant elastic material is translucent or transparent.
19. A method for using the expandable stent deployment assembly of claim l, comprising the steps of:
inserting the expandable stent assembly mounted on a catheter into a patient's body;
maneuvering the expandable stent assembly to a desired location within the patient's body;
causing the stent expansion balloon to expand until the stent has expanded to a desired size;
causing the stent expansion balloon to deflate; and removing the stent expansion balloon and sheath from the patient's body after the sheath disengages from the expanded stent.
20. A method for reducing the frictional forces placed on an expandable stent during stent deployment, comprising the steps of:
inserting a catheter having at a distal end thereof a expandable stent assembly into a patient's body, the expandable stent assembly having a non-compliant stent expansion balloon, a compliant elastic sheath over an outer circumference of the non-compliant stent expansion balloon, and the expandable stent crimped over the compliant elastic sheath; and expanding the non-compliant stent expansion balloon beneath the compliant elastic sheath in order to deploy the stent.
21. A method for manufacturing an expandable stent deployment assembly, comprising the steps of:
expanding in a radial direction a tubular sheath made of a compliant elastic material;
inserting an unexpanded stent expansion balloon mounted on a catheter into the expanded sheath stent assembly;
permitting the expanded sheath to contract and conform to the outer surface of the non-compliant stent expansion balloon;
inserting the assembled non-compliant stent expansion balloon and compliant elastic sheath into an unexpanded stent; and causing the stent to be in contact with the compliant elastic sheath.
22. The method of claim 21, wherein the step of causing the stent to be in contact with the compliant elastic sheath further comprises crimping the stent over the compliant elastic sheath.
CA2471772A 2002-01-04 2002-11-15 Non-compliant balloon with compliant top-layer to protect coated stents during expansion Expired - Fee Related CA2471772C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/035,158 US7070613B2 (en) 2002-01-04 2002-01-04 Non-compliant balloon with compliant top-layer to protect coated stents during expansion
US10/035,158 2002-01-04
PCT/US2002/036670 WO2003059206A1 (en) 2002-01-04 2002-11-15 Non-compliant balloon with compliant top-layer to protect coated stents during expansion

Publications (2)

Publication Number Publication Date
CA2471772A1 true CA2471772A1 (en) 2003-07-24
CA2471772C CA2471772C (en) 2010-09-21

Family

ID=21881007

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2471772A Expired - Fee Related CA2471772C (en) 2002-01-04 2002-11-15 Non-compliant balloon with compliant top-layer to protect coated stents during expansion

Country Status (7)

Country Link
US (2) US7070613B2 (en)
EP (1) EP1460971B1 (en)
JP (1) JP2005514159A (en)
AU (1) AU2002352717A1 (en)
CA (1) CA2471772C (en)
DE (1) DE60233593D1 (en)
WO (1) WO2003059206A1 (en)

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Also Published As

Publication number Publication date
AU2002352717A1 (en) 2003-07-30
US20060206191A1 (en) 2006-09-14
CA2471772C (en) 2010-09-21
JP2005514159A (en) 2005-05-19
DE60233593D1 (en) 2009-10-15
US7070613B2 (en) 2006-07-04
EP1460971A1 (en) 2004-09-29
US20030130716A1 (en) 2003-07-10
EP1460971B1 (en) 2009-09-02
WO2003059206A1 (en) 2003-07-24

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Effective date: 20121115

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