Packaging sheath for drug coated stent

• US 20070061001A1
• Filed: 09/13/2005
• Published: 03/15/2007
• Est. Priority Date: 09/13/2005
• Status: Abandoned Application

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Durcan, Jonathan, McNiven, Andrew
• Application Number:
  US11/225,746
• Publication Number:
  US 20070061001A1
• Time in Patent Office: Days
• US Class Current: 623/1.120
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A sheath for temporarily protecting the drug coating on the surface of a stent after being mounted on a delivery catheter until just before use. The sheath is configured so as to enable its inner diameter to be temporarily increased to facilitate unrestricted fitment about and removal from the stent. Its inner diameter in its relaxed state is selected to be slightly less that the outer diameter of the mounted stent so as to positively grasp the stent and prevent dislodgement.

Claims

1. A sheath for temporarily protecting a mounted stent, comprising:

a generally cylindrical structure having an inner dimension adjustable between a first inner diameter and a second inner diameter, wherein said first inner dimension is slightly less than the outer diameter of said mounted stent and said second dimension is substantially greater than the outer diameter of said mounted stent and wherein said structure is biased toward said first inner diameter.

The sheath of claim 1, wherein said cylindrical structure is longitudinally split along one side and longitudinally hinged along a diametrically opposite side so as to define two opposed sections wherein said opposed sides define said first diameter when in a closed position and said second diameter when in an open position.

5. The sheath of claim 1, wherein said cylindrical structure has helical cut formed there through that extends from its proximal end to its distal end.

8. The sheath of claim 1, wherein said structure has an inner diameter that is substantially constant along its length.

9. The sheath of claim 1, wherein said structure has an inner diameter that varies along its length.

2. The sheath of claim 2, wherein each of said opposed sections has a tab extending radially therefrom adjacent said longitudinally hinged side.

4. The sheath of claim 2, wherein said opposed sections have interlocking teeth defined along said split side.

3. The sheath of claim 3, wherein a compression spring is disposed between said tabs so as to force said opposed sections against one another.

6. The sheath of claim 6, wherein said helical cut defines a pitch angle of about 15°

to 45°

.

7. The sheath of claim 7, wherein said helical split defines a pitch angle of about 30°

.

10. A protected stent assembly, comprising:

a catheter having an expandable balloon;

a drug coated stent crimped onto said balloon;

a protective sheath disposed about said stent, wherein said sheath is manipulatable between a configuration in which its inner diameter is slightly less than said stent'"'"'s outer diameter and a configuration in which its inner diameter is substantially greater than said stent'"'"'s outer diameter.

12. The protected stent assembly of claim 11, wherein said sheath comprises a longitudinally hinged cylindrical structure that is biased into said configuration in which its inner diameter is slightly less than said stent'"'"'s outer diameter.

13. The protected stent assembly of claim 12, wherein said structure is biased by a spring.

14. The protected stent assembly of claim 11, wherein said sheath comprises a cylindrical structure having a helical cut formed there through that extends from its proximal end to its distal end.

15. The protected stent assembly of claim 14, wherein said sheath is constructed of material with an inherent elasticity and said inherent elasticity is relied upon to bias said sheath into said configuration in which its inner diameter is slightly less than said stent'"'"'s outer diameter.

16. A sheath for temporarily protecting a mounted stent, said mounted stent having an outer diameter, comprising a cylindrical structure defined by two longitudinally hinged cylinder halves each having an opposing edge wherein said cylinder halves define an inner diameter that is slightly less than said stent'"'"'s outer diameter when said opposing edges engage one another and an inner diameter that is substantially greater than said stent'"'"'s outer diameter when said opposing edges are forced apart.

17. The sheath of claim 16, wherein said opposing edges are biased toward one another.

18. The sheath of claim 16, wherein each of said opposing edges has teeth formed therein that interlock when said opposing edges engage one another.

19. A sheath for temporarily protecting a mounted stent, said mounted stent having an outer diameter, comprising a cylindrical structure having a helical cut formed there through that extends from a proximal end to a distal end, wherein said cylindrical structure has an inner diameter that is slightly less than said stent'"'"'s outer diameter when said structure is in its relaxed state and an inner diameter that is substantially greater than said stent'"'"'s outer diameter when said ends are twisted relative to one another.

20. The sheath of claim 19, wherein said helical cut forms an angle of between about 15°

and about 45°

relative to said cylindrical structure'"'"'s longitudinal axis.