Balloon catheter having metal balloon and method of making same

• US 8,460,333 B2
• Filed: 10/24/2003
• Issued: 06/11/2013
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Boyle, Christopher T., Bailey, Steven R., Banas, Christopher E., Palmaz, Julio C.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US10/693,572
• Publication Number:
  US 20040181252A1
• Time in Patent Office: 3,518 Days
• Field of Search: 606/190, 606/192, 606/194, 604/96.01, 604/97.01, 604/99.01, 604/101.01, 604/101.02, 60410303-10308
• US Class Current: 606/192
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2310/00395 Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1038 : Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: G03F 7/0002 : Lithographic processes using patterning methods other than those involving the exposure to radiation, e.g. by stamping
• CPC Class Codes: Y10S 977/845 : Purification or separation of fullerenes or nanotubes

Abstract

A metal balloon catheter having a main tubular body, a metal balloon proximate a distal end of the main tubular body, a central annulus extending along an entire longitudinal aspect of the catheter for accommodating a guidewire therethrough and an inflation annulus adjacent the central annulus which extends along the longitudinal axis of the main tubular body and terminates in fluid flow communication with an inflation chamber of the metal balloon. The metal balloon catheter may be either unitary integral metal catheter in which the main tubular body and the balloon are fabricated of metal, or it may consist of a polymeric main tubular body and a metal balloon.

Claims

1. A balloon catheter comprising an inflatable balloon, wherein the inflatable balloon is coaxially disposed about a catheter member such that an inflation lumen is defined intermediate the catheter member and the inflatable balloon, and wherein the inflatable balloon comprises an inner surface, an outer surface, and a wall thickness therebetween, wherein the wall thickness consists of at least one vacuum deposited metal.

2. The balloon catheter according to claim 1, wherein the at least one vacuum deposited metal is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese and molybdenum.

3. The balloon catheter according to claim 1, wherein the wall thickness of the inflatable balloon is between about 0.1 μ

m and 25 μ

m.

4. The balloon catheter according to claim 1, wherein the inflatable balloon deflates under the influence of at least one of a shape memory, superelastic or elastic property of the at least one vacuum deposited metal.

5. The balloon catheter according to claim 1, further comprising a catheter body fabricated from a material selected from the group consisting of polymers and metals.

6. The balloon catheter according to claim 1 made by the method comprising the steps of:

vacuum depositing a film of the at least one vacuum deposited metal onto a generally cylindrical mandrel having a geometry desired for the inflatable balloon to form the inflatable balloon; and

removing the generally cylindrical mandrel from the formed inflatable balloon.

7. The balloon catheter of claim 1, further comprising a catheter body member having a second inflation lumen and at least one inflation port, wherein the at least one inflation port is in fluid flow communication with the inflation lumen of the inflatable balloon.

8. The balloon catheter of claim 1, wherein the at least one vacuum deposited metal is comprised of a radiopaque metal.

9. The balloon catheter of claim 1, wherein the inflatable balloon has conductive properties for transmitting energy delivered from an external source.

10. The balloon catheter of claim 1, wherein the at least one vacuum deposited metal comprises a single layer of a single vacuum deposited metal, multiple layers of a single vacuum deposited layer, or multiple layers of multiple vacuum deposited metals.

11. The balloon catheter of claim 1, wherein the inflation lumen further comprises at least one inflation port, wherein the at least one inflation port is in fluid flow communication with the inflation lumen of the inflatable balloon.

12. The balloon catheter of claim 1, wherein the inflation lumen comprises only one inflation port in the inflation lumen, which is in fluid flow communication with the inflation lumen of the inflatable balloon.

13. The balloon catheter of claim 1, further comprising a catheter body member having a guidewire lumen.

14. A balloon catheter comprising an inflatable balloon coaxially disposed about a catheter member such that an inflation lumen is defined intermediate the catheter member and the inflatable balloon, and wherein the inflatable balloon comprises an inner surface, an outer surface, and a wall thickness therebetween, wherein the wall thickness consists of at least one shape memory metal.

15. A balloon catheter comprising:

a. A catheter body member having a central lumen and an inflation lumen;

b. A balloon diametrically extensible from the catheter body member under the influence of a fluid passing through the inflation lumen and into the balloon, wherein the balloon consists of at least one metal; and

c. A guidewire extending throughout the catheter body.

16. The balloon catheter of claim 15, wherein the guidewire extends through the inflation lumen.

17. The balloon catheter of claim 15, further comprising only one inflation port in the inflation lumen, which is in fluid flow communication with the balloon.

18. The balloon catheter of claim 15, wherein the at least one metal is comprised of a radiopaque metal.

19. The balloon catheter of claim 15, wherein the balloon has conductive properties for transmitting energy delivered from an external source.