Expandable stent with sliding and locking radial elements

• US 6,623,521 B2
• Filed: 12/14/2000
• Issued: 09/23/2003
• Est. Priority Date: 02/17/1998
• Status: Expired due to Term

• Current Assignee: REVA Medical Inc.
• Original Assignee: MD3 Incorporated
• Inventors: Zeltinger, Joan, Koenig, Donald H., Steinke, Thomas A.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/739,552
• Publication Number:
  US 20010044651A1
• Time in Patent Office: 1,013 Days
• Field of Search: 623/1.16, 623/1.15, 623/1.27, 623/1.3, 623/1.42
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

The present invention provides a lumen support stent with a clear through-lumen for use in a body lumen. The stent is formed from at least one series of sliding and locking radial elements and at least one ratcheting mechanism comprising an articulating element and a plurality of stops. The ratcheting mechanism permits one-way sliding of the radial elements from a collapsed diameter to an expanded diameter, but inhibits radial recoil from the expanded diameter.

Claims

1. An expandable intraluminal stent, comprising:

a tubular member comprising a clear through-lumen, and having proximal and distal ends and a longitudinal length defined there between, a circumference, and a diameter which is adjustable between at least a first collapsed diameter and at least a second expanded diameter, said tubular member comprising;

at least one module comprising a series of radial elements, wherein each radial element defines a portion of the circumference of the tubular member and wherein no radial element overlaps with itself in either the first collapsed diameter or the second expanded diameter;

at least one articulating mechanism which permits one-way sliding of the radial elements from the first collapsed diameter to the second expanded diameter, but inhibits radial recoil from the second expanded diameter; and

a frame element which surrounds at least one radial element in each module.

2. The expandable intraluminal stent of claim 1, wherein the tubular member comprises at least two modules, and wherein the frame elements from adjacent modules are coupled.

3. The expandable intraluminal stent of claim 2, wherein the frame elements from adjacent modules are coupled by a linkage element extending between the frame elements.

4. The expandable intraluminal stent of claim 2, wherein the frame elements from adjacent modules are coupled by interlinking of the frame elements.

5. The expandable intraluminal stent of claim 1, wherein each radial element comprises at least one elongated rib disposed between first and second portions.

6. The expandable intraluminal stent of claim 5, wherein the radial elements that comprise a module alternate between radial elements having an odd number of elongated ribs and radial elements having an even number of elongated ribs.

7. The expandable intraluminal stent of claim 5, wherein the radial elements that comprise a module alternate between radial elements having one elongated rib and radial elements have two elongated ribs.

8. The expandable intraluminal stent of claim 1, wherein the tubular member comprises at least two modules which are coupled to one another by at least one linkage element.

9. The expandable intraluminal stent of claim 8, wherein the at least one linkage element is made from a degradable material.

10. The expandable intraluminal stent of claim 1, wherein the radial recoil is less than about 5%.

11. The expandable intraluminal stent of claim 1, wherein said tubular member has a stiffness of s than about 0.1 Newtons force/millimeter deflection.

12. The expandable intraluminal stent of claim 1, wherein said tubular member provides a surface area coverage of greater than about 20%.

13. The expandable intraluminal stent of claim 1, wherein the tubular member is at least partially radiopaque.

14. The expandable intraluminal stent of claim 1, wherein said radial elements are made substantially from a material which is work hardened to between about 25% and 95%.

15. The expandable intraluminal stent of claim 1, the expandable intraluminal wherein the radial elements are made from a material selected from the group consisting of a polymer, a metal, a ceramic, and combinations thereof.

16. The expandable intraluminal stent of claim 15, wherein said material further comprise a bioactive agent.

17. The expandable intraluminal stent of claim 16, wherein the radial elements are adapted to release the bioactive agent during stent deployment when the tubular member is adjusted from the first collapsed diameter to the second expanded diameter.

18. The expandable intraluminal stent of claim 16, wherein the bioactive agent is selected from the group consisting of antiplatelet agents, antithrombin agents, antiproliferative agents and antiinflammatory agents.

19. The expandable intraluminal stent of claim 1, wherein the radial elements are made from a degradable material.

20. The expandable intraluminal stent of claim 19, wherein said degradable material is selected from the group consisting of polyarylates (L-tyrosine-derived), free acid polyarylates, polycarbonates (L-tyrosine-derived), poly(ester-amides), poly(propylene fumarate-co-ethylene glycol) copolymer, polyanhydride esters, polyanhydrides, polyorthoesters, silk-elastin polymers, calcium phosphate and magnesium alloys.

21. The expandable intraluminal stent of claim 19, wherein said degradable material further co rises a bioactive agent, which is released as the material degrades.

22. The expandable intraluminal stent of claim 21, wherein said degradable material is adapted to deliver an amount of the bioactive agent which is sufficient to inhibit restenosis at a site of stent deployment.

23. The expandable intraluminal stent of claim 21, wherein the bioactive agent is selected from the group consisting of antiplatelet agents, antithrombin agents, antiproliferative agents and inflammatory agents.

24. The expandable intraluminal stent of claim 1, comprising at least two modules, wherein the expanded diameters of the first and second modules are different.

25. The expandable intraluminal stent of claim 1, wherein each articulating mechanism comprises a slot and a tab on one radial element and at least one stop on an adjacent radial element which is slideably engaged in the slot, wherein the tab is adapted to engage the at least one stop.

26. The expandable intraluminal stent of claim 25, wherein the at least one stop comprises a hole with a chamfered edge.

27. The expandable intraluminal stent of claim 25, wherein the least one articulating mechanism further comprises an expansion resistor on the slideably engaged radial element, wherein the expansion resistor resists passing through the slot during expansion until further force is applied, such that the radial elements in the module expand in a substantially uniform manner.

28. The expandable intraluminal stent of claim 1, wherein the articulating mechanism further comprises a release, such that actuation of the release permits sliding of the radial elements of the second expanded diameter back to the first collapse diameter.

29. The expandable intraluminal stent of claim 1, further comprising a floating coupling element with an articulating mechanism.