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

• US 9,320,626 B2
• Filed: 06/18/2007
• Issued: 04/26/2016
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Bailey, Steven R., Boyle, Christopher T.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US11/764,744
• Publication Number:
  US 20080027388A1
• Time in Patent Office: 3,235 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.18, 623/1.2, 623/1.34, 623/1.39, 623/1.44, 600/3, 600/434, 600/585, 600/528, 606191-198
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• 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: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/0013 Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/09 Guide wires

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.

Claims

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 having a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance, 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 a radiopaque metal is used to form at least one of the layers.

3. The guidewire of claim 1, wherein the plurality of layers are concentric.

8. The guidewire of claim 1, wherein the thin-film includes a discontinuous column structure across the entire thickness of the thin-film.

9. The guidewire of claim 1, wherein the plurality of layers include a limit of the grain or defect size.

4. 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 having a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance, 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.

5. The assembly of claim 4, wherein the guidewire body is generally tubular.

6. The assembly of claim 4, wherein the first and second biocompatible metals are similar.

7. The assembly of claim 4, 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.

10. The assembly of claim 4, 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.

11. The assembly of claim 4, 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.

12. 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 having a plurality of microperforations that impart at least one of longitudinal compliance and radial compliance, the one thin-film having a plurality of layers.

13. The guidewire of claim 12, wherein a radiopaque metal is used to form at least one of the layers.

14. The guidewire of claim 12, wherein the plurality of layers are concentric.

15. The guidewire of claim 12, wherein the plurality of layers include a limit of the grain or defect size.

16. The guidewire of claim 12, 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.