Formulations for drug-coated medical devices

• US 9,415,140 B2
• Filed: 10/11/2012
• Issued: 08/16/2016
• Est. Priority Date: 10/14/2011
• Status: Active Grant

• Current Assignee: Trireme Medical Incorporated
• Original Assignee: Innora GmbH
• Inventors: Speck, Ulrich
• Primary Examiner(s): Parad, Dennis J
• Assistant Examiner(s): BECKHARDT, LYNDSEY MARIE
• Application Number:
  US14/350,483
• Publication Number:
  US 20140257181A1
• Time in Patent Office: 1,405 Days
• Field of Search: None
• US Class Current: 1/1
• 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 said balloon'"'"'s surface:

a) paclitaxel or a polymer-free paclitaxel preparation; and

b) 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 paclitaxel, 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 angioplasty balloon catheter 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 axial struts cross the radially expandable rings.

3. The angioplasty balloon catheter as in claim 2, wherein the individual struts are each elastic in tension so that they will elongate as the balloon is inflated.

4. The angioplasty balloon catheter according to claim 1, wherein the lipophilic antioxidant is propyl gallate.

5. The angioplasty balloon catheter according to claims 1 or 4, wherein the at least one lipophilic antioxidant is contained at a ratio of 5-100% by weight of the at least one lipophilic antioxidant in relation to 100% by weight of the paclitaxel.

6. The angioplasty balloon catheter according to claim 1 or 4, wherein the antioxidant load is up to 10 μ

g/mm² of coated device surface.

7. The angioplasty balloon catheter according to claim 1, which has been sequentially coated polymer-free with the paclitaxel and at least one lipophilic antioxidant in a way that the paclitaxel and the antioxidant are not homogeneously mixed.

8. The angioplasty balloon catheter according to claim 5, wherein the at least one lipophilic antioxidant is contained at a ratio of 10-100% by weight in relation to 100% by weight of the paclitaxel.

9. The angioplasty balloon catheter according to claim 5, wherein the at least one lipophilic antioxidant is contained at a ratio of 20-100% by weight in relation to 100% by weight of the paclitaxel.

10. The angioplasty balloon catheter according to claim 5, wherein the at least one lipophilic antioxidant is contained at a ratio of 50-100% by weight in relation to 100% by weight of the paclitaxel.