Reinforced and drug-eluting balloon catheters and methods for making same

• US 7,491,188 B2
• Filed: 10/12/2004
• Issued: 02/17/2009
• Est. Priority Date: 10/12/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Schewe, Scott, Weber, Jan, Holman, Thomas J.
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/963,272
• Publication Number:
  US 20060079836A1
• Time in Patent Office: 1,589 Days
• Field of Search: 604/103.01, 604/103.02, 604/96.01, 604/99.04, 604/101.02, 604/101.03, 60410305-10309, 604/103, 604104-107
• US Class Current: 604/103.01
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• 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 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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

Abstract

The present invention generally relates to the field of intravascular medical devices, and more specifically to the field of balloon catheters and other similar diagnostic or therapeutic catheters within the body for treatment and diagnosis of diseases. In particular, the present invention relates to reinforced balloon catheters and drug-eluting balloon catheters and corresponding methods for producing same.

Claims

1. A therapeutic medical article comprising:

an inflatable balloon having an inner surface that defines an inner volume;

an elongate member having an outer surface, the elongate member being disposed within the inner volume of the inflatable balloon such that a lumen is established between the inner surface of the balloon and the outer surface of the elongate member when the balloon is in a non-collapsed state; and

a plurality of flexible hollow members disposed in said lumen, each hollow member comprising an exterior surface and an interior cavity containing a therapeutic agent that serves as a reservoir for the therapeutic agent, wherein a portion of the exterior surface is attached to the inner surface of the balloon, and each hollow member having an associated channel that extends (a) from the outer surface of the balloon to the interior cavity of the hollow member or (b) from the outer surface of the balloon to a puncturing member, disposed between inner surface of the balloon and the exterior surface of the hollow member, which punctures the hollow member upon inflation of the balloon, such that, in either case, the therapeutic agent contained in the interior cavity of the hollow member is forced to exit the device through the channel when the balloon is inflated to working pressure.

2. The therapeutic medical article of claim 1, wherein the channel extends from the outer surface to the balloon to the interior cavity of the hollow member

3. The therapeutic medical article of claim 1, wherein the channel extends from the outer surface to the balloon to said puncturing member.

4. The therapeutic medical article of claim 1, wherein the hollow member is a flexible sac.

5. The therapeutic medical article of claim 1, wherein the hollow member comprises (a) a head portion comprising the exterior surface and the interior cavity and a (b) tail portion which is attached to the outer surface of the elongate member.

6. The therapeutic medical article of claim 1, wherein the therapeutic agent is in the form of a solution, particle dispersion, or gel.

7. The therapeutic medical article of claim 1, wherein the hollow member is a hollow fiber.

8. The therapeutic medical article of claim 1, wherein the channel is provided with a pressure sensitive valve.

9. The therapeutic medical article of claim 1, wherein the channel is blocked with a removable plug.

10. The therapeutic medical article of claim 9, wherein the plug comprises a hydrophilic material selected from the group consisting of biodegradable polymers, polysaccharides and hydrogels.

11. A therapeutic medical article comprising:

an inflatable balloon having an inner surface that defines an inner volume;

an elongate member having an outer surface, the elongate member being disposed within the inner volume of the inflatable balloon such that a lumen is established between the inner surface of the balloon and the outer surface of the elongate member when the balloon is in a non-collapsed state; and

a plurality of flexible hollow members disposed in said lumen, each hollow member comprising an exterior surface and an interior cavity containing a therapeutic agent that serves as a source for the therapeutic agent, wherein a portion of the exterior surface is attached to the inner surface of the balloon, and each hollow member having an associated channel that extends a) from the outer surface of the balloon to the interior cavity of the hollow member or (b) from the outer surface of the balloon to a puncturing member, disposed between inner surface of the balloon and the exterior surface of the hollow member, which punctures the hollow member upon inflation of the balloon, such that, in either case. the therapeutic agent contained in the interior cavity of the hollow member is forced to exit the device through the channel when the balloon is inflated to working pressure, and wherein the hollow members comprise (a) a head portion comprising the exterior surface and the interior cavity and a (b) tail portion which comprises a strand material of solid cross section and which is attached to the outer surface of the elongate member.

12. The therapeutic article of claim 11 wherein said head portion comprises a hollow sac.