Selective stent crimping

• US 8,769,796 B2
• Filed: 03/24/2011
• Issued: 07/08/2014
• Est. Priority Date: 09/25/2008
• Status: Active Grant

• Current Assignee: Advanced Bifurcation Systems, Inc.
• Original Assignee: Advanced Bifurcation Systems, Inc.
• Inventors: Bourang, Henry, Khorsandi, Mehran
• Primary Examiner(s): CIGNA, JACOB JAMES
• Application Number:
  US13/071,239
• Publication Number:
  US 20110307046A1
• Time in Patent Office: 1,202 Days
• Field of Search: 295/05, 295/08, 295/16, 295/21, 623/1.11, 724/02
• US Class Current: 29/508
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus

Abstract

Methods for crimping a stent on an expandable member of a delivery catheter, and devices and methods for treating a bifurcation are disclosed. A method for crimping includes positioning a stent having a first portion and a second portion over the expandable member, and non-uniformly crimping the stent to the expandable member. The method can include routing an elongate shaft under the second portion of the stent and through the side hole so as to be routed external to the first portion. The stent second portion can be crimped so that the elongate shaft can be slidably disposed relative to the stent second portion prior to deployment of the stent.

Claims

1. A method of crimping a stent on an expandable member of a delivery catheter, the method comprising:

positioning a stent over an expandable member, the stent having a distal-most first end and a proximal-most second end, wherein a first portion and a second portion respectively extend between the distal-most first end and proximal-most second end, the stent comprising a sidewall having a side hole therethrough;

routing an elongate shaft under the second portion of the stent and through the side hole so as to be routed external to the first portion; and

non-uniformly crimping the stent to the expandable member, wherein the expandable member comprises a delivery balloon extending between and beyond both the distal-most first end and the proximal-most second end, wherein the stent is non-uniformly crimped such that only a segment of the second portion is embedded in the delivery balloon and the second portion is partially crimped to the expandable member such that the second portion remains uncrimped to the expandable member over a sector of the expandable member; and

wherein crimping the stent second portion comprises;

positioning a spacer between a sector of the elongate shaft and a sector of the stent second portion;

crimping the sector of the stent second portion into contact with the spacer; and

removing the spacer, wherein the elongate shaft is slidably disposed relative to the stent second portion prior to deployment of the stent.

2. The method of claim 1, wherein the first portion is disposed distal to the side hole and the second portion is disposed proximal to the side hole.

3. The method of claim 1, wherein the first portion is crimped using a constricting orifice.

4. The method of claim 1, further comprising:

applying a vacuum pressure to the expandable member; and

checking for leaks while the vacuum pressure is applied to the expandable member.

5. The method of claim 1, further comprising:

at least partially inflating the expandable member; and

checking for leaks while the expandable member is at least partially inflated.

6. The method of claim 1, further comprising partially crimping the second portion to the expandable member to allow slidable movement of an elongate shaft under the second portion.

7. The method of claim 1, wherein the first portion and the second portion are crimped while still permitting an elongate shaft to slidably pass through the side hole.

8. The method of claim 1, wherein the stent second portion is crimped using a constricting orifice.

9. The method of claim 1, wherein:

the stent second portion comprises a side wall having a plurality of apertures therethrough; and

the expandable member at least partially protrudes into one or more of the apertures.

10. The method of claim 1, wherein the spacer comprises a protective sheath.

11. The method of claim 1, further comprising partially inflating the expandable member before or during the crimping of the stent second portion.

12. The method of claim 1, wherein a sector of the second portion is not crimped to a sector of the expandable member.

13. The method of claim 1, wherein the entirety of the first portion of the stent is embedded in the delivery balloon.

14. The method of claim 1, further comprising heating at least one of the expandable member or the stent second portion before or during the crimping of the stent second portion.

15. The method of claim 14, wherein the at least one of the expandable member or the stent second portion are heated to a temperature ranging from about 50 degrees Celsius to about 65 degrees Celsius.

16. The method of claim 1, wherein crimping the stent second portion comprises crimping a sector of the stent second portion into contact with the elongate shaft.

17. The method of claim 16, wherein the elongate shaft is slidably disposed relative to the stent second portion after deployment of the stent.

18. The method of claim 1, further comprising coating the stent with a therapeutic agent.

19. The method of claim 18, wherein the therapeutic agent inhibits restenosis.

20. The method of claim 1, wherein the first portion is uniformly crimped to the expandable member and the second portion is non-uniformly crimped to the expandable member.

21. The method of claim 20, wherein the first portion of the stent is uniformly crimped circumferentially and longitudinally therealong.

22. The method of claim 20, wherein the second portion of the stent is non-uniformly crimped circumferentially therealong.

23. The method of claim 1, wherein:

the stent comprises a sidewall having a plurality of apertures therethrough; and

the expandable member at least partially protrudes into one or more of the apertures.

24. The method of claim 23, further comprising partially inflating the expandable member before or during the crimping.

25. The method of claim 24, wherein the expandable member is inflated during the crimping to a pressure ranging from about 50 psi to about 100 psi.

26. The method of claim 23, further comprising heating at least one of the expandable member or the stent before or during the crimping.

27. The method of claim 26, wherein the at least one expandable member or stent are heated to a temperature ranging from about 50 degrees Celsius to about 65 degrees Celsius.