Sterile cover for compressible stents used in percutaneous device delivery systems

• US 20070162102A1
• Filed: 01/11/2006
• Published: 07/12/2007
• Est. Priority Date: 01/11/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy, Lemmon, Jack
• Granted Patent: US 9,078,781 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

A stent cover for enclosing a compressible stent during a stent crimping process, the stent cover having an outer sheath with a proximal end, a distal end, an end portion at the distal end of the sheath having a first diameter, and a stent-retaining portion adjacent to the end portion and having an uncompressed diameter that is larger than the first diameter of the end portion for retaining a stent in its uncompressed condition.

Claims

1. A stent cover for enclosing a compressible stent during a stent crimping process, the stent cover comprising an outer sheath comprising:

a proximal end;

a distal end;

an end portion extending from the distal end of the sheath and having a first diameter for at least partially surrounding a tip of a catheter; and

a stent-retaining portion adjacent to the end portion and having an uncompressed diameter that is larger than the first diameter of the end portion for retaining a stent in an uncompressed condition.

2. The stent cover of claim 1, wherein the sheath further comprises a wall at its distal end and adjacent to a proximal end of the end portion, wherein the wall extends generally perpendicular to an outer cylindrical surface of the end portion.

3. The stent cover of claim 1, wherein the sheath further comprises a wall at its distal end and adjacent to a proximal end of the end portion, wherein the wall extends at an angle from the end portion toward the stent-retaining portion.

4. The stent cover of claim 1, wherein the stent-retaining portion is deformable under pressure from its uncompressed diameter to a compressed diameter that is smaller than the uncompressed diameter while retaining a stent.

5. The stent cover of claim 1, wherein the sheath further comprises an inner area that is substantially sterile.

6. The stent cover of claim 1, further comprising an end cover removably attached to the proximal end of the sheath for preventing contamination of an inner area of the sheath.

7. The stent cover of claim 6, wherein the stent cover further comprises a flange at the proximal end of the sheath, wherein the flange has an outer diameter that is larger than the uncompressed diameter of the stent-retaining portion and wherein the end cover is removably attached to the flange.

8. The stent cover of claim 1, wherein the sheath further comprises a flange at its proximal end that comprises a generally planar ring that extends circumferentially around the proximal end of the sheath.

9. The stent cover of claim 8, further comprising an end cover releasably attached to at least a portion of the generally planar ring of the flange.

10. The stent cover of claim 9, wherein the end cover is adhered to at least a portion of the flange.

11. The stent cover of claim 9, wherein the end cover further comprises an extending tab that extends beyond the planar ring of the flange in at least one location.

12. The stent cover of claim 6, further comprising a sterile solution contained within the inner area of the sheath.

13. The stent cover of claim 1, in combination with a stented valve positioned within the stent-retaining portion, wherein the stented valve comprises a valve segment secured within a stent frame.

14. The stent cover of claim 13, wherein the valve segment comprises a polymer valve.

15. The stent cover of claim 13, wherein the valve segment comprises a nitinol mesh valve.

16. The stent cover of claim 1, further comprising at least one locator feature for positioning the stent-retaining portion of the sheath relative to a crimping device.

17. The stent cover of claim 16, wherein the at least one locator feature comprises a locating portion of the sheath extending outwardly from the stent-retaining portion, wherein the locating portion of the sheath has a diameter that is larger than the uncompressed diameter of the stent-retaining portion.

18. The stent cover of claim 16, wherein the at least one locator feature comprises a locator tab extending from an outer surface of the stent-retaining portion.

19. The stent cover of claim 16, wherein the at least one locator feature comprises a locator ring extending around the circumference of an outer surface of the stent-retaining portion.

20. The stent cover of claim 16, wherein the at least one locator feature is depressible into an interior space of the stent-retaining portion for positioning a proximal end of a stent within the stent-retaining portion of the sheath.

21. The stent cover of claim 16, wherein the at least one locator feature comprises an area of the stent cover that is visually distinct from the remainder of the stent cover.

22. The stent cover of claim 16, wherein the at least one locator feature comprises an area of the stent cover that is tactilely distinct from the remainder of the stent cover.

23. The stent cover of claim 1, further comprising a locator feature for positioning a stent within the stent-retaining portion of the sheath.

24. The stent cover of claim 1, wherein the stent-retaining portion is deformable from an uncompressed diameter to a smaller diameter in response to at least one external force.

25. The stent cover of claim 1, in combination with a catheter system for percutaneously inserting a stent in an implantation site, the catheter system comprising an elongated catheter with an inflatable balloon located adjacent to its distal end, a stent positioned to at least partially surround the inflatable balloon, and a protective shield slideably mounted for movement between a position where it can cover the balloon and stent to a position where the balloon and stent can be expanded, wherein the stent cover is positioned so that the stent-retaining portion of the sheath at least partially surrounds the stent.

26. A method of preparing a compressible stent for percutaneous insertion into an implantation site using an elongated catheter including at least one expandable balloon, comprising the steps of:

providing a stent cover comprising an outer sheath having a proximal end, a distal end, an end portion extending from the distal end of the sheath and having a first diameter for at least partially surrounding a tip of a catheter, and a stent-retaining portion adjacent to the end portion and having an uncompressed diameter that is larger than the first diameter of the end portion for retaining a stent in its uncompressed condition;

inserting an uncompressed stent into the stent-retaining area of the sheath;

positioning the stent cover and stent so that the uncompressed stent is adjacent to the balloon of the catheter;

simultaneously compressing the stent and sheath with a stent-crimping tool; and

removing the stent cover.

27. The method of claim 26, further comprising the step of sliding a catheter sheath of the catheter over the compressed stent after removing the stent cover.

28. The method of claim 26, wherein the stent cover is provided with a substantially sterile inner area.

29. The method of claim 26, wherein the stent cover further comprises at least one locator feature for positioning the stent cover in a desired position relative to the stent-crimping tool.

30. The method of claim 26, wherein the stent cover further comprises at least one locator feature for positioning the stent in a desired position within the stent-retaining area of the sheath.

31. The method of claim 26, wherein the stent cover is provided with an end cover releasably attached to the proximal end of the sheath, further comprising the step of removing the end cover prior to inserting an uncompressed stent into the sheath.