FORMULATIONS FOR DRUG-COATED MEDICAL DEVICES

• US 20140257181A1
• Filed: 10/11/2012
• Published: 09/11/2014
• Est. Priority Date: 10/14/2011
• Status: Active Grant

• Current Assignee: Trireme Medical Incorporated
• Original Assignee: Innora GmbH
• Inventors: Speck, Ulrich
• Granted Patent: US 9,415,140 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• 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 29/08 Materials for coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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 25/104 used for angioplasty

Abstract

The invention relates to an angioplasty catheter having a balloon and a constraining element carrying at least on a portion of its surface a taxane or taxane preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one antioxidant in relation to 100% by weight of the taxane, wherein a preferred lipophilic antioxidant is propyl gallate. Scoring or cutting balloons as medical devices are excluded.

Claims

1. An angioplasty balloon catheter characterized by a catheter shaft having an inflatable balloon at its distal end and a constraining structure constraining the expansion of the inflatable balloon, said constraining structure having a non-expanded configuration prior to inflation and an expanded configuration which is smaller than an unconstrained size of the balloon so that the structure restrains the balloon inflation along a plurality of crossing channel lines, carrying at least on a portion of its surface a taxane or a polymer-free taxane preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one antioxidant in relation to 100% by weight of the taxane, wherein the at least one lipophilic antioxidant is selected of propyl gallate, nordihydroguaiarectic acid, or resveratrol, wherein scoring or cutting balloons as medical devices are excluded.

2. The medical device as in claim 1, wherein the constraining structure comprises a plurality of circumferentially spaced-apart axial struts and a multiplicity of axially spaced-apart radially expandable rings attached to the axial struts, wherein the axially struts cross the radially expandable rings.

3. The medical device according to claim 2, wherein the angioplasty balloon catheter has a catheter shaft having an inflatable balloon at its distal end and a constraining structure combined with the inflatable balloon, said constraining structure having an expanded configuration which is smaller than an unconstrained size of the balloon so that the structure restrains the balloon inflation along a plurality of crossing channel lines.

4. The medical device as in claims 1-3, wherein the individual struts are each elastic in tension so that they will elongate as the balloon is inflated.

5. The medical device according to any one of claims 1-4, wherein the lipophilic antioxidant is propyl gallate.

6. The medical device according to any one of claims 1-5, wherein the taxane is selected of paclitaxel, protaxel or docetaxel and is preferably paclitaxel.

7. The medical device according to any one of claims 1-6, wherein the at least one lipophilic antioxidant is contained at a ratio of 5-100% by weight, preferably at a ratio of 10-100% by weight, more preferred at a ratio of 20-100% by weight, and even more preferred at a ratio of 50-100% by weight in relation to 100% by weight of the taxane.

8. The medical device according to any one of claims 1-7, wherein the antioxidant load is up to 10 μ

g/mm² of coated device surface.

9. The medical device according to any one of claims 1-8, which has been sequentially coated polymer-free with the taxane and at least one lipophilic antioxidant in a way that the taxane and the antioxidant are not homogeneously mixed.