Balloon expandable crush-recoverable stent device

• US 8,512,394 B2
• Filed: 07/26/2010
• Issued: 08/20/2013
• Est. Priority Date: 07/21/2004
• Status: Expired due to Fees

• Current Assignee: REVA Medical Inc.
• Original Assignee: REVA Medical Inc.
• Inventors: Schmid, Eric V., Morris, Andrew, Nguyen, John, Eisele, Robert F., Howard, Steven C., Padilla, Orlando M., Simpson, Philip J.
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US12/843,838
• Publication Number:
  US 20100292773A1
• Time in Patent Office: 1,121 Days
• Field of Search: 623 115- 118
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

An intraluminal, balloon expandable stent for implantation in a body lumen is disclosed. The present invention provides a lumen support stent with an unobstructed through-lumen for use in a blood vessel. A constraining mechanism is provided for securely maintaining the stent in the collapsed condition during delivery. The stent is preferably formed with a series of interconnected slide and lock mechanisms for permitting movement from a collapsed condition to an expanded condition and inhibiting radial recoil from the expanded condition. The stent may be formed from a shape memory alloy for providing crush-recovery after deployment.

Claims

1. A balloon-expandable crush-recoverable stent, comprising:

a tubular member having a longitudinal axis and a circumferential axis, the tubular member comprising first and second expandable modules linked by at least one flexible member, the at least one flexible member configured to allow the first expandable module to expand to a first expanded diameter and the second expandable module to expand to a second expanded diameter, wherein the first and second expandable modules can be independently actuated and wherein the first and second expanded diameters are independently selectable;

wherein the first expandable module includes a first plurality of substantially non-deforming radial elements slidably-connected to allow the first expandable module to expand from a collapsed diameter to the first expanded diameter in response to an expansive force, a first locking mechanism for maintaining the first expandable module in the expanded diameter after deployment at a treatment site, and a first constraining mechanism for maintaining the first expandable module in the collapsed diameter until released during deployment at a treatment site;

wherein the second expandable module includes a second plurality of substantially non-deforming radial elements slidably-connected to allow the second expandable module to expand from a collapsed diameter to the second expanded diameter in response to an expansive force, a second locking mechanism for maintaining the second expandable module in the expanded diameter after deployment at a treatment site, and a second constraining mechanism for maintaining the second expandable module in the collapsed diameter until released during deployment at a treatment site; and

wherein neither the first constraining mechanism nor the second constraining mechanism pass through a closed passage extending circumferentially between a first opening and a second opening, the first and second openings being substantially perpendicular to the circumferential axis.

2. The stent of claim 1, wherein the first and second modules are substantially identical.

3. The stent of claim 1, wherein at least one of the substantially non-deforming radial elements is fabricated from a shape-memory material for providing crush-recoverability.

4. The stent of claim 1, wherein the first and second constraining mechanisms are configured to be released by radial expansion of an inflatable balloon during deployment at a treatment site.

5. The stent of claim 1, wherein diameter of the deployed stent varies along the longitudinal axis.

6. The stent of claim 1, wherein the first and second locking mechanisms each comprise an engagement member configured to engage one or more teeth disposed on the respective ones of the first and second pluralities of substantially non-deforming radial elements for allowing slidable movement in substantially only one direction.

7. The stent of claim 6, wherein the teeth are deflectable for allowing the engagement members to pass over the teeth during expansion of the respective first and second expandable modules.

8. The stent of claim 1, wherein the first and second expandable modules are configured such that the first and second constraining mechanisms each further comprise a hook disposed along at least one of the radial elements, the hook being configured to be releasably held within a loop-shaped member on an adjacent radial element during delivery to the treatment site.

9. The stent of claim 1, further comprising a retractable sheath sized for enclosing the tubular member during delivery to a treatment site.

10. The stent of claim 1, wherein the radial elements are substantially identical to one another.

11. A balloon-expandable crush-recoverable stent, comprising:

a tubular member comprising;

at least one flexible linkage element connecting at least two expandable modules along a longitudinal axis of the tubular member, wherein each expandable module comprises first and second inner rails and first and second outer rails and a circumferential centerline, each of the first and second inner rails and the first and second outer rails extending from an end portion of the module to a circumferentially opposite end portion of the module, the first outer rail being positioned outwardly of the first inner rail relative to the circumferential centerline, the second outer rail being positioned outwardly of the second inner rail relative to the circumferential centerline, and wherein each module is configured to radially expand independently of the other module thereby allowing the tubular member to be expanded to various diameters along the longitudinal axis of the tubular member;

a locking mechanism provided along the tubular member for maintaining the tubular member in the expanded diameter after deployment at a treatment site; and

a constraining mechanism located on at least one of the outer rails for maintaining the tubular member in the collapsed diameter until released by radial expansion of an inflatable balloon during deployment at a treatment site.

12. The stent of claim 11, wherein the locking mechanism comprises a plurality of teeth along a first end portion and an engagement member along a second end portion and wherein the engagement member is configured for slidable engagement with the teeth.

13. The stent of claim 11, wherein the constraining mechanism comprises a hold-down tab along a first end portion and a recess along a second end portion, wherein the recess is configured for capturing the hold-down tab.

14. The stent of claim 11, wherein the tubular member is configured to deliver a therapeutic agent to a vessel wall at a treatment site.

15. The stent of claim 11, wherein the tubular member is formed from one or more substantially flat sheets fabricated from a shape-memory material, the one or more flat sheets being configured to be rolled into a cylindrical configuration to form the tubular member.

16. The stent of claim 11, wherein the inner and outer sets of rails are substantially parallel to a circumferential centerline of the module.

17. The stent of claim 11, wherein the first and second inner rails are not connected to each other or the outer rails throughout the length of the rails.

18. The stent of claim 11, wherein the constraining mechanism is configured to flex outwards relative to the circumferential centerline.

19. The stent of claim 18, wherein the constraining mechanism comprises a tab and a plurality of circumferentially spaced recesses, the tab being configured to engage at least one of the recesses during radial expansion of the tubular member.

20. The stent of claim 19, wherein the constraining mechanism is configured to flex outwards during engagement of the tab and the at least one of the recesses.