Coating formulations for scoring or cutting balloon catheters

• US 9,173,977 B2
• Filed: 09/27/2012
• Issued: 11/03/2015
• Est. Priority Date: 04/19/2010
• Status: Active Grant

• Current Assignee: Innora Holding GmbH
• Original Assignee: Angioscore Incorporated (Koninklijke Philips N.V.)
• Inventors: Speck, Ulrich, Berg, Madeleine Caroline
• Primary Examiner(s): AHMED, HASAN SYED
• Application Number:
  US13/628,627
• Publication Number:
  US 20130023817A1
• Time in Patent Office: 1,132 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• 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 2300/606 Coatings
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/143 Stabilizers
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• 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 25/104 used for angioplasty
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present invention is related to scoring or cutting balloon catheters carrying at least on a portion of their surface at least one drug or drug preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one lipophilic antioxidant in relation to 100% by weight of the drug, wherein a combination of the at least one drug being a limus drug and the at least one lipophilic antioxidant being butylated hydroxytoluene is excluded.

Claims

1. A scoring or cutting balloon catheter carrying at least on a portion of a surface of the scoring or cutting balloon catheter a coating composition comprising at least one drug or drug preparation and at least one lipophilic antioxidant that will protect the drug from premature loss during delivery to the angioplasty site and that is 3-100% by weight of the at least one drug or drug preparation, wherein the at least one drug or drug preparation is selected from the group consisting of a Limus drug, a cell proliferation inhibitor, and an inhibitor of neovascularization, the at least one lipophilic antioxidant is selected from the group consisting of butylated hydroxytoluene, butylated hydroxyanisole, nordihydroguaiaretic acid, ascorbyl palmitate, and propyl gallate, and wherein a combination of a Limus drug with butylated hydroxytoluene as the lipophilic antioxidant is excluded.

2. The scoring or cutting balloon catheter according to claim 1 wherein the at least one lipophilic antioxidant is contained at a ratio of 5-100% by weight in relation to 100% by weight of the at least one drug or drug preparation.

3. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is more lipophilic than the antioxidant.

4. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is a Limus drug.

5. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is a cell proliferation inhibitor.

6. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is an inhibitor of neovascularization.

7. The scoring or cutting balloon catheter according to claim 1, wherein the at least one antioxidant load is up to 10 μ

g/mm² of coated catheter surface.

8. The scoring or cutting balloon catheter according to claim 1, which has been coated with the at least one drug or drug preparation and the at least one lipophilic antioxidant both together or each is separately dissolved in tetrahydrofuran or a mixture of solvents containing more than 25% (v/v) tetrahydrofuran.

9. The scoring or cutting balloon catheter according to claim 1, which has been coated with the at least one drug or drug preparation and the at least one lipophilic antioxidant both together or each is separately dissolved in acetone or a mixture of solvents containing more than 25% (v/v) acetone.

10. The scoring or cutting balloon catheter according to claim 1 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 at least one drug.

11. The scoring or cutting balloon catheter according to claim 1 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 at least one drug.

12. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is a taxane.

13. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is stable against oxidative decomposition and the at least one drug or drug preparation is selected from the group consisting of paclitaxel, protaxel, and docetaxel.

14. The scoring or cutting balloon catheter according to claim 1, wherein the at least one drug or drug preparation is stable against oxidative decomposition and the at least one drug or drug preparation is paclitaxel.

15. The scoring or cutting balloon catheter according to claim 14, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

16. The scoring or cutting balloon catheter according to claim 1, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

17. The scoring or cutting balloon catheter according to claim 1, wherein the coating composition is polymer-free.

18. The scoring or cutting balloon catheter according to claim 15, wherein the coating composition is polymer-free.

19. The scoring or cutting balloon catheter according to claim 1, wherein the at least one lipophilic antioxidant is selected from the group consisting of butylated hydroxytoluene, butylated hydroxyanisole, nordihydroguaiaretic acid, and propyl gallate.

20. The scoring or cutting balloon catheter according to claim 1, wherein the at least one lipophilic antioxidant is selected from the group consisting of nordihydroguaiaretic acid and propyl gallate.