Catheter assembly with guard

• US 8,961,457 B2
• Filed: 09/29/2011
• Issued: 02/24/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Chappa, Ralph A.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/248,462
• Publication Number:
  US 20120083733A1
• Time in Patent Office: 1,244 Days
• Field of Search: 424/423, 60410302-10309, 604/96.01, 623/1.11
• 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 and an interior surface, wherein a lumen is disposed between the interior surface and a guide passage, 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, wherein the guard includes an interior surface bonded to the outer surface of the expandable and collapsible structure and an exterior surface opposite the interior surface;

wherein the guard defines a plurality of orifices that extend through the interior and exterior surfaces 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 the guard is thermally bonded to the outer surface of the expandable and collapsible structure.

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

4. 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.

5. The catheter assembly of claim 4, wherein the second material is less flexible than the first material.

6. The catheter assembly of claim 4, wherein the second material is different from the first material.

7. The catheter assembly of claim 1, wherein the orifices are generally chevron shaped.

8. The catheter assembly of claim 1, wherein the orifices are channels that extend circumferentially around the expandable and collapsible structure.

9. 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.

10. The catheter assembly of claim 9, wherein the fold line has a reduced thickness.

11. 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.

12. The catheter assembly of claim 11, wherein the protective coating includes a plurality of fatty acids.

13. The catheter assembly of claim 12, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

14. A catheter assembly comprising:

an expandable and collapsible structure having an outer surface and an interior surface, wherein a lumen is disposed between the interior surface and a guide passage, 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.

15. The catheter assembly of claim 14, wherein an interior surface of the guard is bonded to the outer surface of the expandable and collapsible structure.

16. The catheter assembly of claim 14, wherein the guard is thermally bonded to the outer surface of the expandable and collapsible structure.

17. The catheter assembly of claim 14, wherein the guard is bonded to the outer surface of the expandable and collapsible structure by an adhesive.

18. The catheter assembly of claim 14, wherein the second material is different from the first material.

19. The catheter assembly of claim 14, wherein the second material is thicker than the first material.

20. The catheter assembly of claim 14, 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.

21. The catheter assembly of claim 20, wherein the orifices are generally chevron shaped.

22. The catheter assembly of claim 20, wherein the orifices are channels that extend circumferentially around the expandable and collapsible structure.

23. The catheter assembly of claim 14, wherein the guard includes a fold line that extends between a first axial end of the guard and an oppositely disposed second axial end.

24. The catheter assembly of claim 23, wherein the fold line has a reduced thickness.

25. The catheter assembly of claim 14, 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.

26. The catheter assembly of claim 25, wherein the protective coating includes a plurality of fatty acids.

27. The catheter assembly of claim 26, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

28. A catheter assembly comprising:

an expandable and collapsible structure having an outer surface and an interior surface, wherein a lumen is disposed between the interior surface and a guide passage, 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.

29. 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 an expandable and collapsible structure and a guard,

wherein the expandable and collapsible structure has an outer surface, an interior surface., and a lumen disposed between the interior surface and a guide passage, and wherein the guard includes an interior surface bonded to the outer surface of the expandable and collapsible structure and an exterior surface opposite the interior surface;

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

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

30. The method of claim 29, wherein the coating is applied to the reservoirs through a pipette.

31. The method of claim 29, wherein the measured amount is in the range of about 5 μ

L, to about 10 μ

L.

32. The method of claim 29, 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.

33. The catheter assembly of claim 32, wherein the protective coating includes a plurality of fatty acids.

34. The catheter assembly of claim 33, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

35. 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 expandable and collapsible structure has an outer surface, an interior surface, and a lumen disposed between the interior surface and a guide passage, and 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.

36. The method of claim 35, 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.

37. The method of claim 36, wherein the protective coating includes a plurality of fatty acids.

38. The method of claim 37, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.