To provide a method for manufacturing a multi-layer peelable sheath having a formed tip, for use as a medical introducer device, e.g. the sheath for inserting a catheter or the like into a patient.
The manufacturing method includes 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 second composition blends into a multi-layer preform, processing the multi-layer preform 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 manufacturing method includes 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 manufacturing method also incorporates a reducing sintering process for achieving an optimally cured, peelable sheath having excellent tear properties.
PURTELL GEORGE
SPOHN PETER DWIGHT
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