Balloon catheter having metal balloon and method of making same

• US 9,463,305 B2
• Filed: 08/16/2012
• Issued: 10/11/2016
• Est. Priority Date: 11/19/1999
• Status: Expired due to Fees

• 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): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/587,821
• Publication Number:
  US 20120310158A1
• Time in Patent Office: 1,517 Days
• Field of Search: 604/12, 604/101.01, 604/107, 606/194, 606/190, 606/192
• US Class Current: 1/1
• 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:

at least two metal balloons positioned generally concentrically relative to each other and at least one annular lumen defined between the at least two metal balloons, wherein each of the at least two metal balloons consists of metal, and an innermost one of the at least two metal balloons has a solid wall thickness and is coupled at its proximal and distal ends to a catheter body member, and an outermost one of the at least two metal balloons has a plurality of openings passing through a wall thickness and in fluid flow communication with the at least one annular lumen.

2. The catheter of claim 1, further comprising at least one pharmacologically active agent disposed within the annular lumen and elutable through the plurality of openings.

3. The catheter of claim 2, further comprising an inflation lumen and an inflation port, the inflation port being in fluid flow communication with the the inflation lumen.

4. The catheter of claim 3, further comprising an introductory lumen in fluid flow communication with the annular lumen such that the at least one pharmacologically active agent may be introduced into the annular lumen through the introductory lumen.

5. The catheter of claim 2, wherein the plurality of openings are dimensioned to permit elution of the at least one pharmacologically active agent only upon application of a positive pressure to the innermost balloon.

6. The catheter of claim 2, wherein the metal is radiopaque.

7. The catheter of claim 2, wherein the 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.

8. The catheter of claim 2, wherein the wall thickness of each of the at least two metal balloons is between about 3 μ

m and 10 μ

m.

9. The catheter of claim 2, wherein both the at least two metal balloons deflate under the influence of at least one of a shape memory, superelastic or elastic property of the metal.

10. The catheter of claim 2, wherein the catheter body member is fabricated of a material selected from the group consisting of polymers and metals.