Delivery system comprising a self expanding stent
Inventors
Kaufmann, Ralf • Mueller, Hardy • Lesmeister, Rainer • Braun, Michael • Geis, John
Assignees
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Abstract
A delivery system is equipped with a self expanding stent for implantation into a blood vessel, in particular in the region of the aortic arch. The stent has a hollow cylindrical body which is radially compressed for implantation. A pull-back sheath which surrounds the stent and which radially compresses it is also provided for positioning and releasing the stent in the blood vessel. The pull-back sheath has a highly flexible front section which surrounds the stent and which maintains said stent in its compressed state, and has further a more rigid rear section which is connected to the front section and which is designed to transmit torsional and traction forces to the front section.
Core Innovation
The invention relates to a delivery system with a self expanding stent for implantation into a blood vessel in the region of the aortic arch. The system includes a pull-back sheath which surrounds the stent to radially compress it for positioning and releasing in the aortic arch region, and the pull-back sheath maintains the stent in its compressed state during delivery and is configured for releasing the stent in the blood vessel in the region of the aortic arch.
The pull-back sheath comprises a highly flexible front section connected to a more rigid rear section, where the front section maintains the stent in the compressed state and the rear section transmits torsional and traction forces to the front section. The front section and rear section are made from different materials, and the front section consists of a woven textile tube with textile structure.
The woven textile tube is configured to form kinks and folds in response to delivery in the aortic arch region, and the kinks and folds allow flexion movement during delivery of the stent in the blood vessel in the region of the aortic arch. The overall system addresses delivery and retraction behavior in curved anatomies such as the aortic arch by transmitting traction and torsional forces from the rear section to the flexible front section while the front section flexes through kinks and folds.
Additional structural aspects described include an attachment at a conical tip region, including a conical hard tip flange and a conical soft tip, with attachment of the textile tube to the tip flange using thermal shrinkage and/or bonding. A centrally routed guide wire catheter is connected to the tip flange under tensile load, and a stop tube in the rear section abuts the stent to aid advancement.
Claims Coverage
The independent claim provides the core structure of the delivery system, with multiple inventive features focused on a dual-material pull-back sheath and a woven textile front section that deliberately forms kinks and folds to enable flexion movement during delivery in the aortic arch. Dependent claims further refine the sheath-to-tip connection, the textile material and attachment mechanism, and add force-transfer and guide-wire/tip engagement structures.
Dual-material pull-back sheath transmitting torsional and traction forces
A pull-back sheath surrounding the stent for radially compressing the stent for positioning and releasing in the blood vessel in the region of the aortic arch, the pull-back sheath comprising a highly flexible front section and a more rigid rear section connected to the front section, wherein the more rigid rear section transmits torsional and traction forces to the front section, and the front and rear sections are made from different materials.
Woven textile tube front section configured to form kinks and folds
The front section consists of a woven textile tube with textile structure, the front section configured to form kinks and folds in the textile tube during delivery of the stent in the blood vessel in the region of the aortic arch, whereby the kinks and folds allow flexion movement during delivery of the stent in the blood vessel in the region of the aortic arch.
Thermally shrunk textile tube attachment to tip flange
The front section is thermally shrunk onto the tip flange.
Nonreleasable soft conical tip on hard tip flange
A conical soft tip of soft material which is nonreleasably mounted on a conical tip part and sits on a hard tip flange of hard material.
Polyester (PET) woven textile tube
The textile tube is made of polyester material (PET).
Polymer traction tube in rear section
The rear section has a traction tube made of polymer material.
Centrally extending guide wire catheter connected under tensile load
A centrally extending guide wire catheter extends through the tip portion and is connected to the tip flange under tensile load.
Rear stop tube abutting the stent to aid advancement
The rear section comprises a stop tube which abuts the stent to aid advancement while the traction tube enables withdrawal/rotation and stepwise stent release.
Across the independent claim’s core concept and the dependent refinements identified in the provided content, the inventive focus is the dual-material pull-back sheath with a woven textile front section that forms kinks and folds to permit flexion movement during delivery in the aortic arch, together with defined tip/attachment structures and force/guide-wire routing features for controlled positioning and release.
Stated Advantages
Reducing the risk of jamming during delivery/retraction in curved anatomies such as the aortic arch.
Reducing risk of imprecise placement.
Reducing risk of vessel wall damage in curved anatomies such as the aortic arch.
Documented Applications
Delivery system for implanting a self-expanding stent in the blood vessel in the region of the aortic arch.
Use in curved anatomies such as the aortic arch to support controlled positioning and releasing of a radially compressed self-expanding stent.
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