Balloon catheter having metal balloon and method of making same

• US 20040181252A1
• Filed: 10/24/2003
• Published: 09/16/2004
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Palmaz, Julio C., Bailey, Steven R., Boyle, Christopher T.
• Granted Patent: US 8,460,333 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• 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 consisting essentially of at least one metal.

2. The catheter according to claim 1, wherein the at least one 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 thereof.

3. The catheter according to claim 1, wherein the inflatable balloon has a wall thickness between about 3 μ

m and 10 μ

m.

4. The 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 metal.

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

vacuum depositing a film of the at least one metal onto the 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 catheter of claim 1, further comprising a catheter body member having an inflation lumen and at least one inflation port, wherein the at least one inflation port is in fluid flow communication with an inflation lumen of the inflatable balloon.

8. The catheter of claim 1, wherein the inflatable balloon is formed of plural layers of the at least one metal.

9. The catheter of claim 1, wherein the inflatable balloon further comprises a plurality of perfusion ports passing through the inflatable balloon and facilitating fluid flow communication between outside and inside the inflatable balloon.

10. The catheter of claim 1, wherein the inflatable balloon further comprises a plurality of generally linear projections emanating from an exterior surface of the inflatable balloon and extending along a longitudinal axis thereof.

11. The catheter of claim 10, wherein adjacent pairs of generally linear projections define fold lines for the inflatable balloon.

12. The catheter of claim 10, wherein the longitudinal projections form a geometric pattern that is physically complementary to an implantable device that rests on the inflatable balloon and is delivered by the catheter.

13. The catheter of claim 1, wherein the at least one metal is comprised of a radiopaque metal.

14. The catheter of claim 1, further comprising a coating of biocompatible elastomer encapsulating the inflatable balloon.

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

16. A catheter for localized delivery of a bioactive agent comprising a drug-eluting balloon having a first balloon and a second balloon, having a plurality of pores passing therethrough, concentrically positioned over the first balloon in a spaced apart relationship defining an annular lumen therebetween, at least one pharmacologically active agent disposed within the annular lumen and elutable through the second balloon, each of the first and second balloon consisting essentially of at least one metal.

17. The catheter of claim 16, further comprising an inflation lumen and an inflation port, the inflation port being in fluid flow communication between the inflation lumen and the first balloon.

18. The catheter of claim 17, further comprising an introductory lumen in fluid flow communication with the annular lumen such that a pharmacologically active agent may be introduced into the annular lumen through the introductory lumen.

19. The catheter of claim 16, wherein the plurality of pores are dimensioned to permit elution of the at least one pharmacologically active agent only upon application of a positive pressure to the first balloon.

20. The catheter according to claim 16, wherein the at least one metal is radiopaque.

21. The catheter according to claim 16, wherein the at least one 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 thereof.

22. The catheter according to claim 16, wherein the first balloon and the second balloon have wall thicknesses between about 3 μ

m and 10 μ

m.

23. The catheter according to claim 16, wherein both the first and second balloons deflate under the influence of at least one of a shape memory, superelastic or elastic property of the at least one metal.

24. The catheter according to claim 16, further comprising a catheter body fabricated of a material selected from the group consisting of polymers and metals.

25. The catheter according to claim 16 made by the method comprising the steps of:

vacuum depositing a first film of metal onto a generally cylindrical mandrel having a geometry desired in the first balloon to form the first balloon;

depositing a sacrificial layer onto the surface of the first balloon to assume the desired geometry for the second balloon;

vacuum depositing a second film of metal onto the sacrificial layer to form the second balloon; and

removing the formed first and second balloon by eliminating the sacrificial layer and releasing the formed first and second balloon from the generally cylindrical mandrel.