Balloon expandable bioabsorbable stent with a single stress concentration region interconnecting adjacent struts

• US 7,972,373 B2
• Filed: 12/19/2007
• Issued: 07/05/2011
• Est. Priority Date: 12/19/2007
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Advanced Technologies and Regenerative Medicine, LLC
• Inventors: Zhang, Qiang, Contiliano, Joseph H.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Sharma; Yashita
• Application Number:
  US11/959,634
• Publication Number:
  US 20090163989A1
• Time in Patent Office: 1,294 Days
• Field of Search: 623 115- 117, 623/1.2, 623/1.34
• US Class Current: 623/1.15
• 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 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An expandable, implantable medical device, such as an intraluminal stent fabricated from polymeric materials, includes a plurality of elongated struts in consecutive series and alternating stress concentration junctions interconnecting ends of adjacent struts. When the stent is in an expanded condition, the adjacent struts form expanded substantial V-shapes and stresses are concentrated within the junctions. The junctions define pivot points for the respective attached, adjacent struts. Each of the pivot points is located substantially on a line bisecting the V-shapes formed by the struts, when the stent is expanded.

Claims

1. A method of using an implantable medical device in a surgical procedure, said medical device comprising first and second cylindrical hoops arranged to define a single longitudinal axis and radially expandable about said axis from an unexpanded state to an expanded state, said first and second hoops joined one to the other by a plurality of flexible connectors, at least one of said hoops including a plurality of pairs of elongated struts that are substantially longitudinally oriented relative to said axis in said unexpanded state, each of said pairs of struts comprising adjacent first and second struts arranged substantially alongside each other, so as to define an acute angle between said first and second struts in their unexpanded state, said first and second struts having respective end portions adjacent each other and joined to each other by a junction, said first strut having an inner edge and an outer edge opposite said inner edge of said first strut, said second strut having an inner edge and an outer edge opposite said inner edge of said second strut, said inner edge of said first strut being opposed to said inner edge of said second strut, said junction having an inner edge and an outer edge opposite said inner edge of said junction, said inner edge of said junction being continuous with said inner edge of said first strut and said inner edge of said second strut, at least a portion of said inner edge of said junction being convex relative to an imaginary point located between said inner edge of said first strut and said inner edge of said second strut, said at least a portion of said inner edge of said junction intersecting an imaginary line bisecting the acute angle, said junction including a hinge region, and said hinge region being less rigid than said first and second struts, wherein at least one of said flexible connectors is joined directly to one of said first struts, said method comprising the steps of:

implanting said medical device into a body passageway with said first and second hoops in said unexpanded state; and

expanding said at least one of said hoops to said expanded state, such that said first and second struts move uniformly and symmetrically away from the imaginary line bisecting the acute angle in response to the radial expansion of said at least one of said hoops and flex said junction such that stresses generated in said junction during said expanding step are concentrated at said hinge region.

2. The method of claim 1, wherein said hinge region is more ductile than said first and second struts.

3. The method of claim 1, wherein, when said at least one of said hoops is in said expanded state, said stresses are concentrated within said hinge region.

4. The method of claim 3, wherein said concentrated stresses in said hinge region exceed the yield point of said hinge region.

5. The method of claim 4, wherein said concentrated stresses in said hinge region are below the ultimate stress levels of said hinge region.

6. The method of claim 1, wherein said hinge region comprises a polymer having a predetermined molecular orientation.

7. The method of claim 1, wherein said at least one of said hoops is formed from polymeric materials.

8. The method of claim 1, wherein said junction has cross-sections outside of said hinge region and said hinge region has cross-sections that are smaller than said cross-sections of said junction.

9. The method of claim 1, wherein said at least one of said flexible connectors is joined to said one of said first struts such that said hinge region is entirely offset to one side of said at least one flexible connector.

10. The device of claim 1, wherein at least a portion of said outer edge of said junction is convex toward the imaginary point.

11. The device of claim 1, wherein said outer edge of said first strut is continuous with said flexible connector.

12. The device of claim 1, wherein said outer edge of said second strut is continuous with said outer edge of said junction.