Tfx Medical Incorporation

William E Hunt, Jr

Peter Dwight Spohn

George J Purtell

Methods are disclosed for producing multi-layer peelable sheaths having formed tips, for use as medical introducer devices, e.g., sheaths for inserting a catheter or the like into a patient. The methods include the steps of preparing a first composition blend for forming an inner layer of the multi-layer sheath, preparing a second composition blend for forming an outermost layer of the multi-layer sheath, combining the first and the second composition blends into a multi-layer pre-form, processing the multi-layer pre-form for producing tubing, and forming a tip at one end of the tubing using a thermal process, thereby producing the multi-layer sheath having the inner layer, the outermost layer, and the formed tip. The methods of the present invention include adding a detectable material to the blend used for making the inner layer for facilitating external visualization of the multi-layer sheath, thereby achieving a sheath with a formed tip having no visible discoloration. The methods also incorporate a reduced sintering process for achieving an optimally cured, peelable sheath having excellent tear properties.

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Jaffrey, NH, United States of America

William E Hunt, Jr