Balloon catheter for treating stenosis of body passages and for preventing threatening restenosis

• US 9,192,697 B2
• Filed: 02/09/2011
• Issued: 11/24/2015
• Est. Priority Date: 07/03/2007
• Status: Active Grant

• Current Assignee: Hemoteq AG (Freudenberg & Company KG)
• Original Assignee: Hemoteq AG (Freudenberg & Company KG)
• Inventors: Hoffmann, Erika, Horres, Roland, Faust, Volker, Schreiber, Helmut, Von Holst, Armin, Hoffmann, Michael
• Primary Examiner(s): Ziska, Suzanne
• Assistant Examiner(s): WHEELER, THURMAN MICHAEL
• Application Number:
  US13/023,594
• Publication Number:
  US 20110160698A1
• Time in Patent Office: 1,749 Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/80 characterised by a special chemical form
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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

Abstract

The present invention is directed to a method for coating catheter balloons with a defined amount of a pharmacologically active agent, wherein the coating method uses a coating device having a volume measuring device for releasing a measurable amount of a coating solution by means of a dispensing device specifically onto the surface of the catheter balloon.

Claims

1. A catheter balloon coated with a coating, the coating consisting of:

paclitaxel and at least one citrate ester.

2. A catheter balloon according to claim 1, wherein the citrate ester is tributyl citrate, triethyl citrate, acetyl tributyl citrate, acetyl triethyl citrate, or a mixture thereof.

3. A method of treating a patient to lessen occurrence of restenosis at a vascular site, comprising advancing a catheter having a balloon having a coating consisting of an antiproliferative active agent and a member of the group consisting of triethyl citrate, triethyl citrate acetylate, tributyl citrate, and tributyl citrate acetylate to a treatment site of a vessel wall and inflating the balloon to contact the vessel wall and transfer at least some of the antiproliferative active agent to the vessel wall, wherein the antiproliferative active agent is paclitaxel.

4. A method as in claim 3 wherein the member is tributyl citrate acetylate.

5. A method of treating a patient to lessen occurrence of restenosis at a vascular site, comprising advancing a catheter having a balloon having a coating consisting of an antiproliferative active agent and a citrate ester to a treatment site of a vessel wall and inflating the balloon to contact the vessel wall and transfer at least some of the antiproliferative active agent to the vessel wall, wherein the antiproliferative active agent is paclitaxel.