GUIDEWIRES AND THIN FILM CATHETER-SHEATHS AND METHOD OF MAKING SAME
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 method of manufacturing one of a guidewire and a catheter-sheath having a body, the method comprising:
a. providing a substrate having a surface capable of accommodating metal deposition thereon and having a substrate geometry corresponding to at least a portion of the guidewire or catheter-sheath being manufactured;
b. vacuum depositing a thin-film of a biocompatible metal onto the substrate the thin-film forming the body of at least a portion of the guidewire or catheter-sheath; and
c. removing the substrate from the body formed thereon.
2 . The method of claim 1 , further comprising the step of annealing prior to or after the step of removing the substrate from the body.
3 . The method of claim 1 , wherein step (b) further comprises the step of vacuum depositing plural layers of a biocompatible metal onto the substrate.
4 . The method of claim 3 , wherein the step of vacuum depositing plural layers of a biocompatible metal onto the substrate further comprises the step of depositing the plural layers of a biocompatible metal to form a body having a wall thickness between 0.1 and 75 microns.
5 . The method of claim 4 , wherein the step of depositing the plural layers of a biocompatible metal to form a body further comprises forming a body having an outer diameter between 0.2 and 0.75 mm.
6 . The method of claim 1 , wherein the vacuum deposition technique comprises sputtering.
7 . The method of claim 1 , wherein a sacrificial layer is deposited onto the substrate prior to step (b).
8 . The method of claim 1 , wherein the substrate comprises a sacrificial material.
9 . The method of claim 8 , wherein removing the substrate comprises etching the sacrificial material.
10 . The method of claim 1 , wherein the substrate geometry is generally cylindrical.
11 . The method of claim 1 , wherein the substrate geometry has an elliptical transverse cross-section.
12 . The method of claim 1 , wherein the biocompatible metal is selected from the group 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.
13 . The method of claim 1 , wherein step (b) is conducted a plurality of times to form a plurality of successive layers of the deposited biocompatible metal.
14 . The method of claim 13 , wherein the successive layers are concentric.
15 . The method of claim 13 , wherein a radiopaque metal is used to form at least one of the layers.
16 . The method of claim 1 further comprising the steps of heat treating the deposited material at temperature between 450° to about 600° C.
17 . The method of claim 16 wherein the steps of heat treating the deposited material include of heat treating the deposited material for about 0.5 to 60 minutes.