Ten-thousandths scale metal reinforced stent delivery guide sheath or restraint
A high-strength thin-walled tubular material having a lubricious polymer inner layer is disclosed. The tubing may be used in constructing delivery systems for radially expanding prostheses for use in the treatment of atherosclerosis in stenting procedures or a variety of other procedures.
1 . A tube comprising:
an inner polymeric layer, and
an outer metallic layer,
wherein the tube has an outer diameter less than about 0.018 inches and a wall thickness of between about 0.0004 and about 0.002 inches, and
wherein the metallic layer has a thickness between about 0.0002 and about 0.0015 inches.
2 . The tube of claim 1 , further comprising a medial metallic layer between the outer metallic layer and the inner polymeric layer.
3 . The tube of claim 2 , wherein the medial metallic layer comprises a metal selected from aluminum, copper, silver, gold, platinum and palladium.
4 . The tube of claim 3 , wherein the outer metallic layer comprises a metal selected from Nickel, Nickel Sulfamate, High Phosphate Nickel, NiTi, NiCo and CoCr electroplated upon the inner metallic layer.
5 . The tube of claim 1 , wherein the outer metallic layer comprises a metal selected from stainless steel, Nickel and NiTi vacuum deposited upon the inner polymeric layer.
6 . The tube of claim 1 , wherein the outer diameter of the tube is about 0.017 inches or less.
7 . The tube of claim 6 , wherein the outer diameter is about 0.016 inches or less.
8 . The tube of claim 7 , wherein the outer diameter is about 0.015 inches or less.
9 . The tube of claim 8 , wherein the outer diameter is about 0.014 inches or less.
10 . The tube of claim 1 , wherein the polymeric layer has a thickness between about 0.0002 and about 0.001 inches.
11 . The tube of claim 1 , wherein the wall thickness is about 0.0015 inches or less.
12 . The tube of claim 1 , wherein the outer metallic. layer includes a plurality of coatings.
13 . The tube of claim 12 , wherein the coatings comprise different materials.
14 . The tube of claim 13 , without an inner metallic layer.
15 . The tube of claim 1 , consisting of the inner polymeric layer, and the outer metallic layer.
16 . A tube made by a process comprising:
providing a polymeric tube having outer diameter less than about 0.018 inches and a wall thickness of between about 0.00025 and about 0.0015 inches; and
depositing a structural metallic layer having a thickness between about 0.0002 and about 0.001 inches over the polymeric tube.
17 . The tube of claim 16 , wherein the polymeric tube is provided by drawing tubing to size.
18 . The tube of claim 16 , wherein the polymeric tube is provided by depositing polymer upon a mandrel, and the process further comprises removing the mandrel after the depositing.
19 . The tube of claim 18 , wherein the mandrel is removed by etching it from within the polymeric tube.
20 . The tube of claim 16 , wherein the structural metallic layer is deposited directly upon the polymeric tube.
21 . The tube of claim 16 , wherein the process further comprises depositing a highly conductive metallic layer directly upon the polymeric tube and the structural metallic layer is deposited upon the conductive layer by electroplating.
22 . A tube made by a process comprising:
providing a metallic tube having outer diameter less than about 0.018 inches;
providing a polymeric tube within the metallic tube;
forming openings in a wall of the tube;
interlocking the tubes.
23 . The tube of claim 22 , wherein the interlocking is accomplished by expanding at least some portion of the polymeric tube.
24 . The tube of claim 22 , wherein the interlocking is accomplished by collapsing the at least some portion of the metallic tube.
25 . The tube of claim 22 , wherein the interlocking is by bonding to the polymeric tube through at least some of the openings.
26 . A tube made by a process comprising:
winding a ribbon around a mandrel to an outer diameter of less than about 0.018 inches;
welding the ribbon to form a metallic tube.
27 . The tube of claim 26 , wherein a polymer tube is provided within the metallic tube.
28 . The tube of claim 27 , wherein the polymer tube is provided over the mandrel prior to the winding.
29 . The tube of claim 27 , wherein the polymer tube set within the metallic tube after the welding.
30 . A stent delivery system comprising:
an elongate shaft adapted to maintain an axial position of the stent, and a tube according claim 1 , 22 or 26 to hold a stent in a radially compressed configuration until withdrawn from the stent.
31 . The stent delivery system of claim 30 , further comprising a stent held within the tube.
32 . The stent delivery system of claim 31 , wherein the stent is a self-expanding stent.
33 . The stent delivery system of claim 32 , wherein the stent comprises superelastic NiTi alloy.