Ten-thousandths scale metal reinforced stent delivery guide sheath or restraint

• US 20060276886A1
• Filed: 06/07/2005
• Published: 12/07/2006
• Est. Priority Date: 06/07/2005
• Status: Abandoned Application

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: CardioMind, Inc. (Biosensors International Group, Ltd.)
• Inventors: Kavanagh, Joseph Thomas, George, William R.
• Application Number:
  US11/147,999
• Publication Number:
  US 20060276886A1
• Time in Patent Office: Days
• US Class Current: 623/1.440
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61L 29/126 having a macromolecular matrix

Abstract

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.

Claims

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.

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.

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.