STRUCTURED DRUG-ELUTING BALLOON CATHETER

• US 20100312182A1
• Filed: 05/06/2010
• Published: 12/09/2010
• Est. Priority Date: 06/04/2009
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Surber, Bettina, Adden, Nina
• Granted Patent: US 10,786,657 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• 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 25/1029 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
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The invention relates to a balloon catheter featuring—at least on portions of the outward-turned surface of the dilatable area—hair-like extensions, with the average diameter D, the average length L, and the average center-to-center distance P of the hair-like extensions to each other being selected such that a drug on the balloon surface covered with hair-like extensions can essentially be secured by means of capillary forces.

Claims

1. Balloon catheter featuring—

at least on portions of the outward-turned surface of the dilatable area—

hair-like extensions, with the average diameter D, the average length L, and the average center-to-center distance P of the hair-like extensions to each other being selected such that a drug on the balloon surface covered with hair-like extensions can essentially be secured by means of capillary forces.

2. Balloon catheter according to claim 1, characterized in that the hair-like extensions are essentially cylindrical.

3. Balloon catheter according to claim 1, characterized in that D is between about 0.1 to about 5 μ

m

4. Balloon catheter according to claim 1, characterized in that L is between about 0.1 to about 5 μ

m,

5. Balloon catheter according to claim 1, characterized in that P is between about 0.1 to about 7 μ

m,

6. Balloon catheter according to claim 1, characterized in that the D to L ratio is between about 0.5 to about 2.

7. Balloon catheter according to claim 1, characterized in that the P to D ratio is between about 1 to about 50.

8. Balloon catheter according to claim 1, characterized in that the hair-like extensions are coated with a polymer having catechol side groups.

9. Balloon catheter according to claim 8, characterized in that the coating has a thickness of less than 100 nm.

10. Balloon catheter according to claim 1, characterized in that a drug or a solution containing a drug is secured at least on portions of the surface of the hair-like extensions.

11. Balloon catheter according to claim 10, characterized in that the drug represents a cytostatic agent.

12. Method for manufacturing a balloon catheter of claim 1, characterized in that at least a portion of the surface of the one balloon catheter is brought in contact, at least in part, with a solution containing a drug or a drug mixture in the area in which the balloon catheter features hair-like extensions.

13. Balloon catheter manufactured according to a method according to claim 12.

15. A balloon catheter according to claim 1 wherein L is between about 0.15 and about 2 μ

m, and D is between about 0.2 and about 1 μ

m.

16. A balloon catheter according to claim 1 wherein P is between about 0.5 and about 3 μ

m.

17. A balloon catheter according to claim 1, wherein a ratio of D to L is between about 0.75 and 1.5, and wherein a ratio of P to D is between about 1.5 and 10.

18. A balloon catheter according to claim 8, wherein the coating thickness is between about 1 nm and about 50 nm.

19. A balloon catheter according to claim 10 wherein the drug is one of Paclitaxel or Docetaxel.

20. A method of manufacturing a drug-eluting balloon catheter of claim 12, wherein the step of bringing the surface in contact comprises one or more of dipping, steam treatment, spraying or coating.

14. A balloon catheter for use in angioplasty, in percutaneous transluminal angioplasty, or percutaneous transluminal coronary angioplasty, comprising:

a dilatable area having an outward turned surface,

a plurality of cylindrical extensions on the outward turned surface having an average diameter D between about 0.1 to 5 μ

m, an average length L between about 0.1 to about 5 μ

m, and an average center-to-center distance P between about 0.1 to about 7 μ

m, the D and L dimensions selected to result in a D to L ratio of between about 0.5 to about 2 and a P to D ratio of between about 1 to about 50;

a coating having a thickness of less than about 100 nm on the extensions and comprising a polymer having catechol side groups; and

,

a cytostatic agent drug secured to at least a portion of the extensions through capillary forces.