Medical dilation element
Medical dilatation balloons comprise a polymer that has the attribute of memory, and/or is crosslinked to impart memory. Such balloons exhibit a reduced tendency to overinflate at high inflation pressures. Furthermore, such balloons when shrunk radially by the application of heat while restraining axial shrinkage, exhibit customizable linear or non-linear compliance curves and lower crosslinking profile relative to the same balloon when unshrunk. Also disclosed is an expansive element within a tube whose outer diameter is equal to the outer diameter of the tube from which it was made. In addition, disclosed are (a) processes for preparing crosslinkable polymers, (b) joining crosslinked balloons to catheter systems, (c) forming shrunk balloon elements, and (d) forming an expansive element within a tube whose outer diameter is equal to the outer diameter of the tube from which it was made.
1. A medical dilation element comprising a co-extruded tubular balloon portion, with wall portions, end portions, and cone portions, said wall portions formed of a first crosslinked thermoplastic polymeric composition forming a first polymer layer and a second non-crosslinked thermoplastic polymeric composition forming a second polymer layer, wherein said first polymer layer prior to exposure to crosslinking energy comprises a thermoplastic polymer and a functional crosslinking agent and said second polymer layer comprises said thermoplastic polymer without any functional crosslinking agent and wherein said thermoplastic polymer is a polyamide/polyether block copolymer.
2. A medical device comprising a catheter assembly with thermoplastic outer shaft portions and thermoplastic inner shaft portions wherein said shaft portions have inner and outer surfaces, and wherein at least a portion of the second polymer layer of said medical dilation element of claim 1 is fused by heat welding to a surface of at least one of said thermoplastic polymer catheter shafts.
3. A method for manufacturing the medical dilation element of claim 1 by co-extruding a tubular portion comprising said first polymer layer and said second polymer layer, exposing said tubular portion to crosslinking energy, and expanding said tubular portion into said tubular balloon portion suitable for heat welding to a non-crosslinked thermoplastic polymer catheter shaft.