CATHETER ASSEMBLY

• US 20120004605A1
• Filed: 06/30/2011
• Published: 01/05/2012
• Est. Priority Date: 06/30/2010
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Chappa, Ralph A.
• Granted Patent: US 10,596,355 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

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 coating is disposed on the outer surface of the expandable and collapsible structure. The coating includes a bioactive agent. A sleeve is disposed over the coating. The sleeve is adapted to expand between a compressed state and an enlarged state and to return to the compressed state. The sleeve defines a plurality of openings in the compressed state. An outer diameter of the coating is less than an outer diameter of the sleeve when the expandable and collapsible structure is in the contracted state and greater than the outer diameter of the sleeve when the expandable and collapsible structure is in 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 coating disposed on the outer surface of the expandable and collapsible structure, the coating including a bioactive agent; and

a sleeve disposed over the coating, the sleeve being adapted to expand between a compressed state and an enlarged state and to return to the compressed state, the sleeve defining a plurality of openings in the compressed state;

wherein an outer diameter of the coating is less than an outer diameter of the sleeve when the expandable and collapsible structure is in the contracted state and greater than the outer diameter of the sleeve when the expandable and collapsible structure is in the dilated state.

2. The catheter assembly of claim 1, wherein the sleeve includes:

a first axial end and an oppositely disposed second axial end;

an exterior surface that extends between the first and second axial ends;

an interior surface that extends between the first and second axial ends, the interior surface defining a bore in which the expandable and collapsible structure is disposed;

a plurality of rails extending between the first and second axial ends, the plurality of rails defining the plurality of openings, wherein the openings extend through the interior and exterior surfaces.

3. The catheter assembly of claim 2, wherein the rails extend longitudinally between the first and second axial ends.

4. The catheter assembly of claim 3, wherein the sleeve includes a plurality of ribs that extends between adjacent rails.

5. The catheter assembly of claim 4, wherein the ribs are disposed at oblique angles relative to the rails.

6. The catheter assembly of claim 1, wherein a material of the sleeve includes a nickel-titanium alloy.

7. The catheter assembly of claim 1, wherein the coating softens or melts at a temperature between room temperature and body temperature.

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

9. The catheter assembly of claim 8, wherein the protective coating includes a plurality of fatty acids.

10. The catheter assembly of claim 9, wherein the plurality of fatty acids is solid at room temperature and soft or liquid at a body temperature of a subject.

11. The catheter assembly of claim 1, further comprising a second expandable and collapsible structure disposed adjacent to a proximal end of the expandable and collapsible structure.

12. 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;

an agent coating disposed on the outer surface of the expandable and collapsible structure, the agent coating including a bioactive agent;

a protective coating disposed on the first coating, the second coating including a mixture of fatty acids; and

a sleeve disposed over the protective coating, the sleeve being adapted to expand between a compressed state and an enlarged state, the sleeve including a plurality of rails that extend longitudinally between a first axial end and an oppositely disposed second axial end, the plurality of rails defining a plurality of openings, the protective coating being accessible through the openings in the compressed state, wherein a size of each of the openings increases in the enlarged state.

13. The catheter assembly of claim 12, wherein a material of the sleeve includes a nickel-titanium alloy.

14. The catheter assembly of claim 12, wherein the sleeve includes a plurality of ribs that extends between adjacent rails.

15. The catheter assembly of claim 14, wherein the ribs are disposed at oblique angles relative to the rails.

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

17. The catheter assembly of claim 16, wherein the mixture of fatty acids comprises oleic acid, dodecanoic acid, or salt thereof.

18. The catheter assembly of claim 12, wherein the bioactive agent comprises an antiproliferative agent, an antiinflamatory agent, or an antiplatelet agent.

19. The catheter assembly of claim 12, further comprising a release coating disposed between the outer surface of the expandable and collapsible structure and the agent coating, the release coating being adapted to promote the release of the agent coating.

20. The catheter assembly of claim 12, further comprising a second expandable and collapsible structure disposed adjacent to a proximal end of the expandable and collapsible structure.

21. 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 coating disposed on the outer surface of the expandable and collapsible structure, the coating including a bioactive agent;

a sleeve disposed over the coating, the sleeve being adapted to expand between a compressed state and an enlarged state, the sleeve including;

a body having an interior surface and an exterior surface;

the interior surface defining a bore in which the expandable and collapsible structure is disposed;

the body defining a plurality of openings that extend through the interior and exterior surfaces, wherein the plurality of openings define an area at the exterior surface in the compressed state that is about 40% to about 95% of a total surface area of the exterior surface in the compressed state.

22. The catheter assembly of claim 21, wherein a material of the sleeve includes a nickel-titanium alloy.

23. The catheter assembly of claim 22, wherein the body of the sleeve includes a plurality of rails that extends between a first end of the body and an oppositely disposed second end of the body.

24. The catheter assembly of claim 23, wherein body includes a plurality of ribs that extends between adjacent rails.

25. The catheter assembly of claim 21, wherein the coating includes an agent coating having the bioactive agent and a lipid coating disposed on the agent coating.

26. A sleeve for a catheter assembly comprising:

a body having a first axial end, an oppositely disposed second axial end, an exterior surface and an oppositely disposed interior surface, the body defining a bore that extends through the first and second axial ends and a plurality of openings that pass through exterior and interior surfaces, the body being adapted to expand from a compressed state to an enlarged state in response to a force acting on the interior surface and to return to the compressed state from the enlarged state when the force is removed, wherein the plurality of openings define an area at the exterior surface in the compressed state that is about 40% to about 95% of a total surface area of the exterior surface in the compressed state.

27. The sleeve of claim 26, wherein the body includes a plurality of rails disposed between the first and second axial ends.

28. The sleeve of claim 27, wherein each of the plurality of rails forms an annular ring.

29. The sleeve of claim 28, wherein each of the plurality of rails includes an undulation.

30. The sleeve of claim 29, wherein the body includes a plurality of ribs that is engaged to adjacent rails.

31. The sleeve of claim 30, wherein each of the ribs includes an undulation.

32. The sleeve of claim 26, wherein the body includes a plurality of rails that extends between the first and second axial ends.

33. The sleeve of claim 32, wherein each of the plurality of rails includes an undulation.

34. The sleeve of claim 33, wherein the undulation is generally sinusoidal in shape.

35. The sleeve of claim 32, wherein each of the plurality of rails is generally parallel to an adjacent rail in the compressed state.

36. The sleeve of claim 32, wherein each of the plurality of rails is generally helically disposed about a central longitudinal axis of the body in the compressed state.

37. The sleeve of claim 32, wherein body includes a plurality of ribs that extends between adjacent rails.

38. The sleeve of claim 37, wherein each of the plurality of ribs includes an undulation.

39. The sleeve of claim 26, wherein a material of the body includes a nickel-titanium alloy.

40. 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 having a distal end and an oppositely disposed proximal end;

a sleeve disposed about the outer surface of the expandable and collapsible structure, the sleeve including a body having a first axial end, an oppositely disposed second axial end, an exterior surface and an oppositely disposed interior surface, the body defining a bore in which at least a portion of the expandable and collapsible structure is disposed, the bore extending through the first and second axial ends, the body defining a plurality of openings that pass through exterior and interior surfaces, the body being adapted to expand from a compressed state to an enlarged state when the expandable and collapsible structure is in the dilated state and to return to the compressed state from the enlarged state when the expandable and collapsible structure is in the contracted state, wherein the plurality of openings define an area at the exterior surface in the compressed state that is about 40% to about 95% of a total surface area of the exterior surface in the compressed state.