Guidewires and thin film catheter-sheaths and method of makng same

Abstract

Guidewires and thin-film catheter-sheaths, fabricated using vacuum deposition techniques, which are monolayer or plural-layer members having ultra-thin wall thicknesses to provide very-low profile delivery assemblies for introduction and delivery of endoluminal devices.

1 . A guidewire comprising a tubular guidewire body formed only of a thin-film consisting of a plurality of layers, wherein each layer consists of a vacuum deposited biocompatible metal, where the tubular guidewire body defines a guidewire lumen and extends from a proximal end to a distal end defining an entire longitudinal length of the guidewire. 
     
     
         2 . The guidewire of  claim 1 , wherein the guidewire body further comprises a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance. 
     
     
         3 . The guidewire of  claim 1 , wherein a radiopaque metal is used to form at least one of the layers. 
     
     
         4 . The guidewire of  claim 1 , wherein the plurality of layers are concentric. 
     
     
         5 . The guidewire of  claim 1 , wherein the thin-film includes a discontinuous column structure across the entire thickness of the thin-film. 
     
     
         6 . The guidewire of  claim 1 , wherein the plurality of layers include a limit of the grain or defect size. 
     
     
         7 . An assembly for delivering a medical device via a patient's vascular system, the assembly comprising:
 a guidewire comprising a guidewire body formed only of a first thin-film comprising a plurality of layers of a first biocompatible metal, the first thin-film formed by a vacuum deposition technique, where the guidewire body defines a guidewire lumen and extends from a proximal end to a distal end defining an entire longitudinal length of the guidewire; and   a catheter-sheath having a tubular catheter-sheath body, the catheter-sheath body comprising a second thin-film of a second biocompatible metal formed by a vacuum deposition technique, the catheter-sheath body defining a catheter-sheath lumen; wherein the guidewire is positioned coaxially within the lumen of the catheter-sheath, and wherein the medical device is concentrically positioned within a distal portion of the catheter-sheath lumen and intermediate the catheter-sheath body and the guidewire body, thereby forming the assembly.   
     
     
         8 . The assembly of  claim 7 , wherein the guidewire body is generally tubular. 
     
     
         9 . The assembly of  claim 7 , wherein at least one of the guidewire body and the catheter-sheath body further comprises a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance. 
     
     
         10 . The assembly of  claim 7 , wherein the first and second biocompatible metals are similar. 
     
     
         11 . The assembly of  claim 7 , wherein the medical device is selected from the group consisting of a stent, a graft, a stent-graft, a valve, a filter, an occluder, and a patch. 
     
     
         12 . The assembly of  claim 7 , wherein the second thin-film comprises a plurality of layers and at least one of the first and second thin-films includes a discontinuous column structure across the entire thickness of the plurality of layers. 
     
     
         13 . The assembly of  claim 7 , wherein the second thin-film comprises a plurality of layers, and the plurality of layers of at least one of the first and second thin-films include a limit of the grain or defect size. 
     
     
         14 . A guidewire having a tubular guidewire body defining a guidewire lumen and extending from a proximal end to a distal end defining an entire longitudinal length of the guidewire, wherein the tubular guidewire body consists of only a thin-film of a biocompatible metal, the thin-film having a plurality of layers. 
     
     
         15 . The guidewire of  claim 14 , wherein the guidewire body further comprises a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance. 
     
     
         16 . The guidewire of  claim 14 , wherein a radiopaque metal is used to form at least one of the layers. 
     
     
         17 . The guidewire of  claim 14 , wherein the plurality of layers are concentric. 
     
     
         18 . The guidewire of  claim 14 , wherein the plurality of layers include a limit of the grain or defect size. 
     
     
         19 . The guidewire of  claim 14 , wherein the biocompatible metal is selected from the group of biocompatible materials consisting of elemental titanium, vanadium, aluminum, nickel tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, nitinol, and stainless steel. 
     
     
         20 - 34 . (canceled)