Scimed Life Systems, Inc.

Andrew G Richardson

Henry John Pepin

Michael S Ferrandino

Peter Trexler Keith

Scott P Thome

William F Kratoska

Sew-Wah Tay

The present invention comprises a method and device for providing an expandable introducer sheath. The method of employing the inventive device comprises inserting an elongate flexible tubular sheath into a vessel (with a proximal end of the sheath extending proximally outward through the skin), to slidably receive intravascular devices. When a larger size introducer sheath is desired, the sheath is manipulated while still in the vessel to expand its inner diameter to a larger size. In one embodiment, the sheath is made of a shape-memory polymer and is manipulated by inserting a heated mandrel (with an outer diameter larger than the inner diameter of the sheath) within the sheath to cause the sheath to expand to an inner diameter at least approximately equal to an outer diameter of the mandrel. The shape-memory polymer material ensures that the sheath will retain its expanded inner diameter. Alternatively, the sheath is formed from a telescoping multi-tubular arrangement of progressively larger tubes. In any case, insertion of the inventive sheath into the skin requires only a single small puncture which is then only expanded as needed while the sheath remains in place.

Expandable introducer sheath

Process for forming a dimensionally variable tubular member for use in catheterization procedures. The process includes a mechanism for extruding a tubular member. A variable speed puller pulls the tubular member through or from the extrusion means at a selectively variable speed. A variable air or gas pressure supply supplies pressurized air or gas to the extrusion mechanism at a selectively variable rate. The dimensionally varying tubular member may be cut to desired lengths for use as catheter shafts or catheter soft tips. The process may include forming a tubular member having a dimensionally varying first layer and a dimensionally varying second layer, wherein a portion of the first layer at a distal end of the tubular member is removed.

Process to form dimensionally variable tubular members for use in

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Chanhassen, MN, United States of America

Andrew G Richardson