Structured drug-eluting balloon catheter

• US 10,786,657 B2
• Filed: 05/06/2010
• Issued: 09/29/2020
• Est. Priority Date: 06/04/2009
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Adden, Nina, Surber, Bettina
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US12/774,894
• Publication Number:
  US 20100312182A1
• Time in Patent Office: 3,799 Days
• Field of Search: 60410301-10302, 60410306, 60410308, 623 111, 427 21, 424424
• 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. A balloon catheter featuring at least on portions of an outward-turned surface of a dilatable area thereof hair-like extensions, with an average diameter D, an average length L, and an average center- to-center distance P of the hair-like extensions to each other being selected such that a defined amount of a given drug on the balloon surface covered with hair-like extensions is secured through capillary forces to surfaces of the hair like extensions, and wherein P is at least twice as large as D.

2. The balloon catheter according to claim 1, characterized in that the hair-like extensions are essentially cylindrical, and wherein L is between about 0.1 and 0.9 μ

m.

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

m.

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

m.

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

m.

6. The balloon catheter according to claim 1, characterized in that a ratio of D to L is between about 0.5 to about 2.

7. The balloon catheter according to claim 1, characterized in that -a ratio of P to D is between about 2 to about 50.

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

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

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

12. A method for manufacturing a balloon catheter of claim 1, characterized in that at least a portion of the outward-turned surface 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.

14. The 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.

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

m, and wherein each of the hair-like extensions has a flat top end that is distal from the outward-turned surface.

16. The 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.

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

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

19. The 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.

20. The balloon catheter according to claim 1, wherein the hair-like extensions consist of materials or material compositions that provide a stability and stiffness such that the hair-like extensions stick out upright from the balloon surface.

13. 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 1.5 to about 50, each of the extensions having a substantially flat top end that is distal from the outward turned surface;

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

, a defined amount of a given cytostatic agent drug secured to at least a portion of surfaces of the extensions through capillary forces, wherein the defined amount is set by selection of values of D, L, and P.