CATHETER ASSEMBLY WITH GUARD

• US 20120083733A1
• Filed: 09/29/2011
• Published: 04/05/2012
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Chappa, Ralph A.
• Granted Patent: US 8,961,457 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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

Abstract

A catheter assembly includes an expandable and collapsible structure having an outer surface. The expandable and collapsible structure is adapted to expand between a contracted state and a dilated state. A guard is bonded to the outer surface of the expandable and collapsible structure. The guard and the expandable and collapsible structure cooperatively define a plurality of reservoirs. A coating disposed in the reservoirs. The coating includes a bioactive agent. The coating protrudes from the reservoirs when the expandable and collapsible structure is expanded to the dilated state.

Claims

1. A catheter assembly comprising:

an expandable and collapsible structure having an outer surface, the expandable and collapsible structure being adapted to expand between a contracted state and a dilated state;

a guard bonded to the outer surface of the expandable and collapsible structure, the guard and the expandable and collapsible structure cooperatively defining a plurality of reservoirs; and

a coating disposed in the reservoirs, the coating including a bioactive agent, wherein the coating protrudes from the reservoirs when the expandable and collapsible structure is expanded to the dilated state.

2. The catheter assembly of claim 1, wherein an interior surface of the guard is bonded to the outer surface of the expandable and collapsible structure.

3. The catheter assembly of claim 1, wherein the guard is thermally bonded to the outer surface of the expandable and collapsible structure.

4. The catheter assembly of claim 1, wherein the guard is bonded to the outer surface of the expandable and collapsible structure by an adhesive.

5. The catheter assembly of claim 1, wherein the expandable and collapsible structure is made of a first material and the guard is made of a second material.

6. The catheter assembly of claim 5, wherein the second material is less flexible than the first material.

7. The catheter assembly of claim 5, wherein the second material is different from the first material.

8. The catheter assembly of claim 1, wherein the guard includes:

an interior surface bonded to the outer surface of the expandable and collapsible structure;

an exterior surface opposite the interior surface;

wherein the guard defines a plurality of orifices that extend through the interior and exterior surfaces.

9. The catheter assembly of claim 8, wherein the orifices are generally chevron shaped.

10. The catheter assembly of claim 8, wherein the orifices are channels that extend circumferentially around the expandable and collapsible structure.

11. The catheter assembly of claim 1, wherein the guard includes a fold line that extends between a first axial end of the guard and an oppositely disposed second axial end.

12. The catheter assembly of claim 11, wherein the fold line has a reduced thickness.

13. The catheter assembly of claim 1, wherein the coating includes an agent coating having a bioactive agent and a protective coating having a fatty acid, the protective coating being disposed on the agent coating.

14. The catheter assembly of claim 13, wherein the protective coating includes a plurality of fatty acids.

15. The catheter assembly of claim 14, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

16. A catheter assembly comprising:

an expandable and collapsible structure having an outer surface, the expandable and collapsible structure being adapted to expand between a contracted state and a dilated state, the expandable and collapsible structure being made of a first material;

a guard bonded to the outer surface of the expandable and collapsible structure, the guard being made of a second material that is less flexible than the first material, the guard and the expandable and collapsible structure cooperatively defining a plurality of reservoirs with the outer surface of the expandable and collapsible structure forming base walls of the reservoirs and the guard forming sidewalls of the reservoirs; and

a coating disposed in the reservoirs, the coating including a bioactive agent, wherein the coating protrudes from the reservoirs when the expandable and collapsible structure is expanded to the dilated state.

17. The catheter assembly of claim 16, wherein an interior surface of the guard is bonded to the outer surface of the expandable and collapsible structure.

18. The catheter assembly of claim 16, wherein the guard is thermally bonded to the outer surface of the expandable and collapsible structure.

19. The catheter assembly of claim 16, wherein the guard is bonded to the outer surface of the expandable and collapsible structure by an adhesive.

20. The catheter assembly of claim 16, wherein the second material is different from the first material.

21. The catheter assembly of claim 16, wherein the second material is thicker than the first material.

22. The catheter assembly of claim 16, wherein the guard includes:

an interior surface bonded to the outer surface of the expandable and collapsible structure;

an exterior surface opposite the interior surface;

wherein the guard defines a plurality of orifices that extend through the interior and exterior surfaces.

23. The catheter assembly of claim 22, wherein the orifices are generally chevron shaped.

24. The catheter assembly of claim 22, wherein the orifices are channels that extend circumferentially around the expandable and collapsible structure.

25. The catheter assembly of claim 16, wherein the guard includes a fold line that extends between a first axial end of the guard and an oppositely disposed second axial end.

26. The catheter assembly of claim 25, wherein the fold line has a reduced thickness.

27. The catheter assembly of claim 16, wherein the coating includes an agent coating having a bioactive agent and a protective coating having a fatty acid, the protective coating being disposed on the agent coating.

28. The catheter assembly of claim 27, wherein the protective coating includes a plurality of fatty acids.

29. The catheter assembly of claim 28, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

30. A catheter assembly comprising:

an expandable and collapsible structure having an outer surface, the expandable and collapsible structure being adapted to expand between a contracted state and a dilated state;

a guard disposed on the outer surface of the expandable and collapsible structure, the guard including a fold line that extends between a first end of the guard and an oppositely disposed second end, the fold line having an area of reduced thickness, the guard and the expandable and collapsible structure cooperatively defining a plurality of reservoirs with the outer surface of the expandable and collapsible structure forming base walls of the reservoirs and the guard forming sidewalls of the reservoirs; and

a coating disposed in the reservoirs, the coating including a bioactive agent, wherein the coating protrudes from the reservoirs when the expandable and collapsible structure is expanded to the dilated state.

31. A method of applying a coating to a catheter assembly, the method comprising:

heating a coating so that the coating is in a flowable state;

applying a measured amount of the coating to reservoirs cooperatively defined by a expandable and collapsible structure and a guard that is bonded to an outer surface of the expandable and collapsible structure; and

cooling the coating so that the coating is in a non-flowable state.

32. The method of claim 31, wherein the coating is applied to the reservoirs through a pipette.

33. The method of claim 31, wherein the measured amount is in the range of about 5 μ

L to about 10 μ

L.

34. The method of claim 31, wherein the coating includes an agent coating having a bioactive agent and a protective coating having a fatty acid, the protective coating being disposed on the agent coating.

35. The catheter assembly of claim 34, wherein the protective coating includes a plurality of fatty acids.

36. The catheter assembly of claim 35, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

37. A method of applying a coating to a catheter assembly, the method comprising:

applying a coating to an exterior surface of a guard that is affixed to an expandable and collapsible structure of a catheter assembly, wherein the guard and the expandable and collapsible structure define a plurality of reservoirs having openings at the exterior surface of the guard;

placing the guard and expandable and collapsible structure in an inner bore of a sheath;

heating the coating so that the coating is in a flowable state; and

sliding the guard and expandable and collapsible structure out of the sheath so that coating on the exterior surface of the guard is substantially removed.

38. The method of claim 37, wherein the coating includes an agent coating having a bioactive agent and a protective coating having a fatty acid, the protective coating being disposed on the agent coating.

39. The catheter assembly of claim 38, wherein the protective coating includes a plurality of fatty acids.

40. The catheter assembly of claim 39, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.