Coating formulations for scoring or cutting balloon catheters

• US 10,471,184 B2
• Filed: 05/14/2019
• Issued: 11/12/2019
• Est. Priority Date: 04/19/2010
• Status: Active Grant

• Current Assignee: Spectranetics LLC (Koninklijke Philips N.V.)
• Original Assignee: Angioscore Incorporated (Koninklijke Philips N.V.)
• Inventors: Speck, Ulrich, Berg, Madeline Caroline
• Primary Examiner(s): Ahmed, Hasan S
• Application Number:
  US16/412,151
• Publication Number:
  US 20190298887A1
• Time in Patent Office: 182 Days
• 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 method of manufacturing a medical device for use in angioplasty or coronary angioplasty, comprising:

providing a balloon catheter, the balloon catheter comprising;

a shaft having a proximal portion and a distal portion;

an inflatable balloon coupled to the distal portion of the shaft;

a nonimplantable scoring structure surrounding the balloon; and

spraying a coating composition onto at least a portion of a surface of the balloon catheter, the coating composition comprising at least one drug and at least one lipophilic antioxidant, the coating composition being 3-100% by weight of the at least one drug, wherein the at least one drug is selected from the group consisting of a Limus drug, a cell proliferation inhibitor, and an inhibitor of neovascularization, wherein the at least one lipophilic antioxidant is selected from the group consisting of butylated hydroxytoluene, butylated hydroxyanisole, nordihydroguaiaretic acid, ascorbyl palmitate, and propyl gallate, wherein a combination of a Limus drug with butylated hydroxytoluene as the lipophilic antioxidant is excluded, wherein the at least one lipophilic antioxidant protects the at least one drug from premature loss.

2. The method according to claim 1, wherein the scoring structure comprises one or more wires.

3. The method according to claim 1, wherein the coating composition is sprayed onto the inflatable balloon.

4. The method according to claim 3, wherein the at least one drug comprises an oxidation-insensitive taxane selected from the group consisting of paclitaxel, protaxel and docetaxel.

5. The method according to claim 4, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

6. The method according to claim 4, wherein the oxidation-insensitive taxane is oxidation-insensitive paclitaxel.

7. The method according to claim 6, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

8. The method according to claim 3, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

9. The method according to claim 3, wherein the at least one antioxidant load is up to 10 μ

g/mm² of the surface.

10. The method according to claim 9, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid.

11. The method 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.

12. The method according to claim 11, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid and the at least drug comprises oxidation-insensitive paclitaxel.

13. The method 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.

14. The method according to claim 13, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid and the at least drug comprises oxidation-insensitive paclitaxel.

15. The method 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.

16. The method according to claim 15, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid and the at least drug comprises oxidation-insensitive paclitaxel.

17. The method according to claim 1, 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 at least one drug.

18. The method according to claim 17, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid and the at least drug comprises oxidation-insensitive paclitaxel.

19. The method according to claim 1, wherein the balloon catheter further comprises a coating composition including the therapeutically effective amount of at least one drug and an amount of at least one lipophilic antioxidant, wherein the coating composition is polymer-free.

20. The method according to claim 19, wherein the at least one lipophilic antioxidant is nordihydroguaiaretic acid and the at least drug comprises oxidation-insensitive paclitaxel.