WO2004096091A1 - Loading and delivery of self-expanding stents - Google Patents
Loading and delivery of self-expanding stents Download PDFInfo
- Publication number
- WO2004096091A1 WO2004096091A1 PCT/EP2004/004486 EP2004004486W WO2004096091A1 WO 2004096091 A1 WO2004096091 A1 WO 2004096091A1 EP 2004004486 W EP2004004486 W EP 2004004486W WO 2004096091 A1 WO2004096091 A1 WO 2004096091A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- stent
- sheath
- pusher
- lumen
- protrusions
- Prior art date
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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- 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
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
Definitions
- EP-A-836 447 discloses a system for delivering a self- expanding stent, in which a stopper ring on an inner catheter abuts the proximal end of the stent tube during proximal withdrawal of a sheath which surrounds the stent.
- nickel titanium shape memory alloy known under the trade mark NITINO .
- NITINO nickel titanium shape memory alloy
- Such stents are typically loaded into a delivery system at a low temperature when the crystal structure of the material is martensitic, and with a memory of a radially expanded shape, characteristic of a higher temperature austenitic crystalline structure.
- the nickel titanium material is biologically compatible and the martensite/austenite transformation occurs between room temperature and body temperature .
- the stent has to be maintained at the stenting site during proximal withdrawal of the surrounding sheath, for progressive release of the stent at the stenting site. If there is no structure within the lumen of the stent, then the entire stress imposed on the stent, to prevent it moving proximally with the proximally withdrawing surrounding sheath, has to be carried on the proximal end annulus of the compressed stent. Often this is not really a problem, especially when the stent is short and not particularly highly compressed radially inwardly, and especially when friction between the compressed stent and the surrounding sheath can be brought to a particularly low value.
- a stent tube made of metal is susceptible to fatigue failure, if only because it is subject to cyclic stress at the frequency of the heartbeat of the body in which it is installed. For this reason, regulatory authorities require stringent fatigue performance standards which impose on manufacturers of stents and delivery systems an onerous burden to avoid any unforeseen stresses on the stent tube.
- a method of loading a self-expanding stent into a delivery sheath as defined in claim 1 below.
- protrusions will achieve the desired pushing effect when the pusher is subject to axial stress.
- arranging the protrusions helically would allow the pusher to be withdrawn from the stent lumen, even while the stent is within the sheath of the delivery system, simply by "unscrewing” the shaft of the pusher until the helical protrusions emerge, by continued rotation of the pusher relative to the stent, out of the lumen of the stent.
- the stent body carries a ring of tantalum radiopaque markers 28 at its distal end and a second ring of radiopaque tantalum markers 30 at its proximal end. It will be appreciated that the presence of these markers may further militate against pushing structures that bear against the end surface of the stent to be deployed.
- the stent delivery system can be arranged as an over the wire system with a full length guidewire lumen, or a rapid exchange system with a guidewire lumen only in a distal zone of the system.
- the outer sheath 10 can be withdrawn by a full length outer catheter or a pull wire within a shaft lumen.
- delivery systems of the present Applicant see WO 03/003944 and PCT/EP2004/000248.
- the inner catheter has an abluminal surface 44 which carries on it a wire 46 arranged as a helix so as to provide a plurality of protrusions (at least when seen in section as in the drawing) on the abluminal surface 44.
- the wire is of stainless steel, fixed to the stainless steel tube 40 by deposits 50 of a bonding material which could be a weld bead or a suitable adhesive.
- the inner ePTFE layer 24 moves radially outwardly away from the protrusions 48 until, with complete withdrawal of the tip 12 proximally beyond the proximal ring of radiopaque markers 30, the stent is fully released. It will be appreciated that there is then a substantial annular gap between the lumen of the expanded stent and the envelope containing the protrusions 48, enabling the inner catheter 40 also to be withdrawn proximally from the lumen of the stent without any snagging of the inner catheter 40 on any part of the stent.
- an analogous sequence of steps may be performed, with radially inward compression of the stent body down onto the protrusions 48 of a loading tool which has a shape in section analogous to that of the inner catheter 40.
- the illustrated embodiment shows a system in which the tapered distal tip of the stent delivery system is carried on the distal end of the outer catheter.
- Those skilled in the art are well-aware that many proposed delivery systems feature a tapered tip on the inner catheter instead.
- the present invention is just as useful in such systems as it is in systems, as illustrated, with the tapered tip on the outer catheter.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Claims
Priority Applications (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04729838A EP1617789B1 (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
JP2006505303A JP4719853B2 (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
CA2523557A CA2523557C (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
MXPA05011600A MXPA05011600A (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents. |
AT04729838T ATE494858T1 (en) | 2003-04-28 | 2004-04-28 | LOADING AND APPLYING SELF-EXPANDABLE STENTS |
US10/552,886 US8287582B2 (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
DE602004031005T DE602004031005D1 (en) | 2003-04-28 | 2004-04-28 | LOAD AND ATTACH SELF-EXPANDABLE STENTS |
US13/648,781 US9072623B2 (en) | 2003-04-28 | 2012-10-10 | Loading and delivery of self-expanding stents |
US14/792,587 US9889005B2 (en) | 2003-04-28 | 2015-07-06 | Loading and delivery of self-expanding stents |
US15/894,428 US10806572B2 (en) | 2003-04-28 | 2018-02-12 | Loading and delivery of self-expanding stents |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0309616.1 | 2003-04-28 | ||
GBGB0309616.1A GB0309616D0 (en) | 2003-04-28 | 2003-04-28 | Loading and delivery of self-expanding stents |
Related Child Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/522,886 A-371-Of-International US20050256092A1 (en) | 2002-08-01 | 2003-08-01 | Antipsoriatic agent |
US10522886 A-371-Of-International | 2004-04-24 | ||
US10/552,886 A-371-Of-International US8287582B2 (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
US13/648,781 Division US9072623B2 (en) | 2003-04-28 | 2012-10-10 | Loading and delivery of self-expanding stents |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004096091A1 true WO2004096091A1 (en) | 2004-11-11 |
WO2004096091A8 WO2004096091A8 (en) | 2005-03-10 |
Family
ID=9957266
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2004/004486 WO2004096091A1 (en) | 2003-04-28 | 2004-04-28 | Loading and delivery of self-expanding stents |
Country Status (9)
Country | Link |
---|---|
US (4) | US8287582B2 (en) |
EP (1) | EP1617789B1 (en) |
JP (1) | JP4719853B2 (en) |
AT (1) | ATE494858T1 (en) |
CA (1) | CA2523557C (en) |
DE (1) | DE602004031005D1 (en) |
GB (1) | GB0309616D0 (en) |
MX (1) | MXPA05011600A (en) |
WO (1) | WO2004096091A1 (en) |
Cited By (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005030092A3 (en) * | 2003-09-25 | 2005-07-21 | Angiomed Ag | Lining for bodily lumen |
WO2007004076A3 (en) * | 2005-05-09 | 2007-05-18 | Angiomed Gmbh & Co | Implant delevery device |
WO2008063496A2 (en) * | 2006-11-13 | 2008-05-29 | Flexible Stenting Solutions, Llc | Delivery system catheter with rotating distal end |
US7666217B2 (en) | 2004-10-29 | 2010-02-23 | Boston Scientific Scimed, Inc. | Implantable medical endoprosthesis delivery systems and related components |
WO2010086320A1 (en) | 2009-01-29 | 2010-08-05 | Angiomed Gmbh & Co. Medizintechnik Kg | Delivery device for delivering a stent device |
EP2491894A1 (en) | 2008-12-31 | 2012-08-29 | Angiomed GmbH & Co. Medizintechnik KG | Stent delivery device with rolling stent retaining sheath |
US8287582B2 (en) | 2003-04-28 | 2012-10-16 | C. R. Bard, Inc. | Loading and delivery of self-expanding stents |
US8500785B2 (en) | 2004-07-13 | 2013-08-06 | Boston Scientific Scimed, Inc. | Catheter |
US8657867B2 (en) | 2008-12-30 | 2014-02-25 | C. R. Bard, Inc. | Stent delivery device |
US8920484B2 (en) | 2009-05-29 | 2014-12-30 | C. R. Bard, Inc. | Transluminal delivery system |
US9089449B2 (en) | 2008-10-08 | 2015-07-28 | C. R. Bard, Inc. | Method of transferring a stent device from a crimping head to an outer sheath of a stent device delivery system |
US9168164B2 (en) | 2010-12-01 | 2015-10-27 | C. R. Bard, Inc. | Device to release a self-expanding implant |
US9387101B2 (en) | 2007-10-17 | 2016-07-12 | C.R. Bard, Inc. | Delivery system for a self-expanding device for placement in a bodily lumen |
US9687369B2 (en) | 2009-12-03 | 2017-06-27 | C.R. Bard, Inc. | Stent device delivery system with an outer sheath polymeric reinforcement layer |
US9687370B2 (en) | 2008-05-09 | 2017-06-27 | C.R. Bard, Inc. | Method of loading a stent into a sheath |
US9717612B2 (en) | 2009-12-03 | 2017-08-01 | C.R. Bard, Inc. | Stent device delivery system with a varying radial profile pull member |
US9724216B2 (en) | 2009-12-03 | 2017-08-08 | C. R. Bard, Inc. | Stent device delivery system with inwardly tapering stent bed |
US9833349B2 (en) | 2008-08-21 | 2017-12-05 | C. R. Bard, Inc. | Method of loading a stent into a sheath |
US10278845B2 (en) | 2009-12-03 | 2019-05-07 | C. R. Bard, Inc. | Stent device delivery system with a heat shrink resistant support member |
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US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
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Also Published As
Publication number | Publication date |
---|---|
US9072623B2 (en) | 2015-07-07 |
JP4719853B2 (en) | 2011-07-06 |
EP1617789A1 (en) | 2006-01-25 |
EP1617789B1 (en) | 2011-01-12 |
JP2006524524A (en) | 2006-11-02 |
US20170319339A9 (en) | 2017-11-09 |
US20180235754A1 (en) | 2018-08-23 |
MXPA05011600A (en) | 2005-12-15 |
WO2004096091A8 (en) | 2005-03-10 |
US20150305866A1 (en) | 2015-10-29 |
US20130079863A1 (en) | 2013-03-28 |
US9889005B2 (en) | 2018-02-13 |
GB0309616D0 (en) | 2003-06-04 |
US8287582B2 (en) | 2012-10-16 |
ATE494858T1 (en) | 2011-01-15 |
US20070083256A1 (en) | 2007-04-12 |
DE602004031005D1 (en) | 2011-02-24 |
CA2523557C (en) | 2011-08-30 |
CA2523557A1 (en) | 2004-11-11 |
US10806572B2 (en) | 2020-10-20 |
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