Edwards Lifesciences Corporation

St Jude Medical, Atrial Fibrillation Division, Inc

Vascular Medcure, Inc.

Duy Nguyen

Kim D Nguyen

Thanh Van Nguyen

Guy P Vanney

Sheldon J Nelson

Elizabeth Nee

Erik E Bulman

Rajan Hansji

Systems and methods can remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism, deep vein thrombosis, cerebrovascular embolism, and other vascular occlusions. The capture system can include a tubular body comprising a first end, a second end, and an axial length therebetween, the first end having an opening and a capture guide. The capture system can include one or more tensioners coupled to the capture guide. The tubular body has a first configuration in which the first end and the capture guide are expanded while the second end and a majority of the tubular body remains compressed. The tubular body is transformable to a second configuration by application of tension by the tensioners. The catheter can remove a large volume of clot.

Axial lengthening thrombus capture system, tensioning system and expandable funnel catheter

Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Expandable sheath for introducing an endovascular delivery device into a body

Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member through which the cardiovascular device and its delivery system pass. In an embodiment, the annular inner member can be formed by coextruding a first and second material. The first material includes a fold, and the second material radially spaces the different parts of the fold from each other during fabrication and provides support for maintaining the tubular structure. The second material is removed once the coextrusion process is complete.

Methods of making an expandable sheath

Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with an intermediate layer including an expandable mesh tube, an outer polymeric layer extending over at least a portion of the intermediate layer, and an inner polymeric layer extending within the intermediate layer. The intermediate layer and the inner polymeric layer are configured to establish an enlarged lumen to allow passage of the prosthetic heart valve.

The invention provides a deflectable catheter capable of forming many variable radius spiral forms from a single, flexible, distal end section. In one aspect, the catheter employs a variable radius control wire to extend or deform a pre-formed loop structure into a three dimensional spiral-like form or geometry. The ability of a single catheter to create a multitude of shapes and sizes allows users to access to a number of anatomical areas without changing the catheter during a procedure or treatment. In another aspect, the invention encompasses methods of producing deflectable variable radius catheters, where two or more regions of the catheter having common control wires are fused or formed onto one another.

Deflectable variable radius catheters

An introducer sheath has a radially unexpanded and a radially expanded configuration, where the sheath locally expands from the unexpanded configuration to the expanded configuration when a device is advanced through a lumen thereof, and locally contracts back to the unexpanded configuration after the device advances past that location. Embodiments of the introducer sheath include an outer tubular layer comprising a longitudinal cut therethrough, and an inner tubular layer comprising at least one pleat extending through the longitudinal cut to an outside surface of the outer tubular layer. Embodiments of the inner tubular layer are adhered to an inner surface of the outer tubular layer, with the pleat not adhered to an outer surface of the outer tubular layer.

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Corona, CA, United States of America

Duy Nguyen