Stent with anchors to prevent vulnerable plaque rupture during deployment

• US 7,258,697 B1
• Filed: 12/22/2003
• Issued: 08/21/2007
• Est. Priority Date: 12/22/2003
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Cox, Daniel L., Feezor, Christopher
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Kotini; Pavitra
• Application Number:
  US10/744,115
• Time in Patent Office: 1,338 Days
• Field of Search: 623/1.12, 623 114- 116, 623/1.32, 623/1.28, 623/1.1, 623/1.11
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A stent for implantation in a body lumen for protecting from rupture a fibrous cap in order to treat vulnerable plaque. One embodiment of the stent achieves staged expansion through stronger and weaker circumferential regions, and includes optional anchors positioned at the circumferential transition between the stronger and weaker regions. During the first stage expansion, the weaker region expands moving the anchors laterally apart. The anchors straddle the fibrous cap and embed into the vessel wall. The second stage expansion of the stent exerts gentler stresses by the weaker region against the fibrous cap while the stronger region exerts greater stresses on the remainder of the vessel wall to open the vessel.

Claims

1. An intravascular stent, comprising:

a plurality of rings having struts and aligned along a common longitudinal axis to define a tube having a circumference;

a link substantially parallel to the longitudinal axis and interconnecting adjacent rings;

a first region spanning an arc along the circumference and axially along the length of the stent;

a second region, excluding the first region, spanning the circumference and axially along the length of the stent, wherein the struts in the first region are structurally weaker than the struts in the second region; and

at least one radially outwardly extending anchor disposed on the link along the circumference such that every anchor is at a transition between the first region and the second region.

2. The stent of claim 1, wherein the at least one anchor extends lengthwise substantially along a length of the link and includes a wedge-shaped cross-section.

3. The stent of claim 1, wherein the stent further comprises a plurality of anchors that are aligned lengthwise parallel to the longitudinal axis of the stent and a gap is located lengthwise between adjacent anchors.

4. The stent of claim 1, wherein the at least one anchor is coated with a therapeutic agent.

5. The stent of claim 1, wherein the link includes an undulating portion along a length thereof.

6. The stent of claim 1, wherein the stent further comprises at least two radially outwardly extending anchors each disposed along the circumference at a respective transition between the first region and the second region, and wherein when the stent is inflated, the anchors are embedded in opposite shoulders of a lipid pool in a patient'"'"'s vessel.

7. The stent of claim 1, wherein the struts in the first region include undulations with peaks and valleys, and reinforcing members with peaks and valleys that subtend the peaks of the struts.

8. The stent of claim 1, wherein the rings include a first material, and the anchors include a second material that is more flexible than the first material.

9. The stent of claim 8, wherein the second material includes a superelastic nickel-titanium alloy.

10. The stent of claim 1, the stent includes a nickel-titanium alloy that is self-contracting through a phase change in the alloy.

11. The stent of claim 1, wherein the at least one anchor includes a cutting edge.

12. The stent of claim 1, wherein the stent when expanded includes an asymmetrical circular cross-sectional shape wherein the first region is less arcuate than the second region.

13. The stent of claim 1, wherein at least a portion of the stent includes a coating of a drug or therapeutic agent.

14. A balloon expandable intravascular stent for use in a body lumen, comprising:

a plurality of rings, each ring having struts, aligned along a common longitudinal axis of the stent and defining a stent circumference;

a first region spanning a first angular distance along the stent circumference;

a second region spanning a second angular distance along the stent circumference excluding the first angular distance, the struts in the first region being relatively smaller than the struts in the second region;

a first transition at a first interface between the first region and the second region,

the first transition extending the length of the stent along a line which is substantially parallel to the longitudinal axis of the stent;

a second transition at a second interface between the first region and the second region, the second transition extending the length of the stent along a line which is substantially parallel to the longitudinal axis of the stent;

a first series of links interconnecting each pair of adjacent rings, the links of the first series positioned substantially along the first transition and aligned linearly;

a second series of links interconnecting each pair of adjacent rings, the links of the second series positioned substantially along the second transition and aligned linearly;

at least one anchor positioned such that every anchor is on an outer surface of the first series of links and aligned with the links of the first series; and

at least one anchor positioned such that every anchor is on an outer surface of the second series of links and aligned with the links of the second series.

15. The stent of claim 14, further comprising a plurality of links interconnecting adjacent rings and not disposed at the first and second transitions.

16. The stent of claim 14, wherein at least one of the links of the first series includes an undulating portion, and at least one of the links of the second series includes an undulating portion.

17. A method of providing a stent, comprising:

aligning a plurality of rings along a common longitudinal axis of the stent and defining a stent circumference, wherein each ring includes struts;

defining a first region spanning a first angular distance along the circumference of the stent;

defining a second region spanning a second angular distance along the circumference of the stent excluding the first angular distance, wherein the struts of the first region are relatively weaker than the struts of the second region;

defining a first transition between the first region and the second region, the first transition extending the length of the stent along a line substantially parallel to the longitudinal axis of the stent;

defining a second transition between the first region and the second region, the second transition extending the length of the stent along a line substantially parallel to the longitudinal axis of the stent;

interconnecting a pair of adjacent rings with a first link, the first link being positioned substantially along the first transition;

interconnecting a pair of adjacent rings with a second link, the second link being positioned substantially along the second transition;

providing at least one anchor on an outer surface of at least one of the first and second links;

positioning the stent in a target area including the vulnerable plaque;

aligning the first region of the stent to substantially overly the vulnerable plaque;

expanding the first region until substantially fully deployed and the at least one anchor is embedded into the vessel wall proximate to and on opposite sides of the vulnerable plaque; and

expanding the second region of the stent until the second region of the stent is fully deployed.

18. The method of claim 17, wherein the stent includes a superelastic nickel-titanium alloy wherein the stent is shape set to have a smaller diameter in the austenitic phase and is expanded to a larger diameter in the martensitic phase.

19. The method of claim 17, wherein during expansion of the first region, the anchors are spread apart by greater than about 180 degrees.

20. An intravascular stent for use in a body lumen, comprising:

a plurality of rings, each ring having struts and being aligned along a common longitudinal axis of the stent and defining a stent circumference;

a first region spanning a first angular distance along the circumference of the stent;

a second region spanning a second angular distance along the circumference of the stent excluding the first angular distance, the struts of the first region being relatively weaker than the struts of the second region;

a first transition between the first region of the circumference of the stent and the second region of the circumference of the stent, the first transition extending the length of the stent along a line substantially parallel to the longitudinal axis of the stent;

a second transition between the first region of the circumference of the stent and the second region of the circumference of the stent, the second transition extending the length of the stent along a line which is substantially parallel to the longitudinal axis of the stent;

a first link interconnecting each pair of adjacent rings along the length of the stent,

the first link positioned substantially along the first transition;

a second link interconnecting each pair of adjacent rings along the length of the stent, the second link positioned substantially along the second transition;

at least one anchor positioned on an outer surface of the first link; and

at least one anchor positioned on an outer surface of the second link.