Apparatus for a stent or other medical device having a bistable spring construction

• US 7,235,097 B2
• Filed: 07/29/2003
• Issued: 06/26/2007
• Est. Priority Date: 08/07/2002
• Status: Active Grant

• Current Assignee: CeloNova Stent, Inc.
• Original Assignee: Paragon Intellectual Properties, LLC
• Inventors: Calisse, Jorge, Besselink, Petrus A.
• Primary Examiner(s): Dawson; Glenn K.
• Assistant Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/523,959
• Publication Number:
  US 20060155360A1
• Time in Patent Office: 1,428 Days
• Field of Search: 623 111- 123, 623 149- 154
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A stent is described comprising a unit cell having a negative spring rate and a bistable function. The unit cell comprises first and second segments, the first segment being more rigid than the second segment. The second segment is coupled to the first segment, and the first segment comprises a substantially fixed sinusoidal shape. In the contracted state, the second segment is held stable in a sinusoidal shape, but when a force is applied the second segment bends out to a stable, convex-shaped deployed state. The second segments withstand the application of radial forces in the convex-shaped deployed state, and diametral recoil of the stent is minimized.

Claims

1. An expandable tubular member comprising a plurality of unit cells, each unit cell comprising a first segment having proximal and distal ends and a substantially sinusoidal shape, and a second segment having proximal and distal ends, the proximal end of the first segment being coupled to the proximal end of the second segment, the distal end of the first segment being coupled to the distal end of the second segment, the second segment being more flexible than the first segment,

wherein the unit cell has a stable contracted state in which the second segment substantially conforms to the sinusoidal shape of the first segment, and a deployed state in which the second segment has a convex shape bowed away from the first segment,

wherein around a circumference of the expandable tubular member, two second segments are disposed between every two first segments and coupled directly to one another.

2. The expandable tubular member of claim 1 wherein the second segment of each unit cell is coupled to the first segment so that the first segment inhibits deformation of the second segment in the contracted state.

3. The expandable tubular member of claim 1 wherein the second segment of each unit cell is stable only in the contracted and deployed states.

4. The expandable tubular member of claim 1 wherein the first segment of each unit cell is substantially rigid.

5. The expandable tubular member of claim 1 wherein the first segment of each unit cell comprises a larger cross sectional area than the second segment.

6. The expandable tubular member of claim 1 wherein the first and second segments of each unit cell are manufactured using different materials.

7. The expandable tubular member of claim 1 wherein the proximal and distal ends of the first and second segments of each unit cell are coupled together by hinges.

8. The expandable tubular member of claim 7 wherein the hinges of each unit cell are elastic hinges.

9. The expandable tubular member of claim 7 wherein the hinges of each unit cell are plastic hinges.

10. The expandable tubular member of claim 1 wherein the unit cells are transformed from the contracted state to the deployed state by application of a uniform radially outwardly directed force to an interior surface of the expandable tubular member.

11. The expandable tubular member of claim 1 wherein a first subset of the plurality of unit cells has a second segment with a first cross-sectional area and a second subset of the plurality of unit cells has a second segment with a second cross-sectional area.

12. The expandable tubular member of claim 1 wherein the plurality of unit cells are arranged in a longitudinally arranged series of circumferential rings.

13. The expandable tubular member of claim 1 wherein the expandable tubular member is capable of attaining different outer diameters depending on the amount and location of unit cells that are transformed to the deployed state.

14. The expandable tubular member of claim 1 wherein the unit cells are designed and arranged to provide a range of diameters for the expandable tubular member in a stepwise fashion.

15. The expandable tubular member of claim 14 wherein the expandable tubular member has an initial diameter at a first end, a final diameter at a second end, and at least one intermediate diameter between the first and second ends, the intermediate diameter differing from the initial and final diameters.

16. The expandable tubular member of claim 15 wherein the initial and final diameters are the same.

17. The expandable tubular member of claim 12 wherein within a circumferential ring, a first subset of unit cells has a different force-displacement characteristic than a second subset of the plurality of unit cells.

18. The expandable tubular member of claim 1 wherein the second segment of each unit cell is coupled to the second segment of an adjacent cell by a joint disposed near a midpoint of the second segments.

19. The expandable tubular member of claim 1 wherein the expandable tubular member is made from a polymer, a metal, a composite, a shape memory material with superelastic behavior, a shape memory material with temperature sensitive behavior, or a combination of two or more of these materials.

20. A method for deploying an expandable tubular member having two substantially stable states, the method comprising:

providing an expandable tubular member comprising a plurality of unit cells in a contracted state, wherein each unit cell comprises a first segment having proximal and distal ends and a substantially sinusoidal shape, and second segment having proximal end that is coupled to the proximal end of the first segment and distal end that is coupled to the distal end of the first segment, the second segment being more flexible than the first segment, wherein the second segment substantially conforms to the sinusoidal shape of the first segment in the contracted state, wherein around a circumference of the expandable tubular member, two second segments are disposed between every two first segments and coupled directly to one another; and

deploying at least one of the unit cells of the expandable tubular member by causing the second segment of the unit cell to deploy to a convex shape bowed away from the first segment of the unit cell.

21. The method of claim 20 wherein the expandable tubular member is provided in the contracted state by compressing the expandable tubular member onto a delivery device.

22. The method of claim 21 wherein at least one unit cell is deployed by applying a radially outward force by expanding the delivery device.

23. The method of claim 20 wherein unit cells of the expandable tubular member are deployed in a stepwise fashion.

24. The method of claim 20 wherein the number of unit cells that are deployed is proportionate to a radially outward force that is applied to the expandable tubular member.

25. The method of claim 20 wherein unit cells are selectively deployed by providing second segments having varying diameters.

26. The method of claim 20 wherein the diameter of the expandable tubular member in a deployed state is varied by varying lengths of first and second segments of a unit cell.

27. The method of claim 20 wherein the diameter of the expandable tubular member in a deployed state is varied by varying the number of unit cells that are provided in the contracted state.