Bistable spring construction for a stent and other medical apparatus

• US 7,828,836 B2
• Filed: 10/11/2002
• Issued: 11/09/2010
• Est. Priority Date: 01/24/1997
• Status: Expired due to Term

• Current Assignee: CeloNova Stent, Inc.
• Original Assignee: Nexeon MedSystems, Inc.
• Inventors: Besselink, Petrus Antonius
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/270,771
• Publication Number:
  US 20030074052A1
• Time in Patent Office: 2,951 Days
• Field of Search: 623/1.15, 623/1.2, 623/1.18, 623/1.19, 623/1.16, 606191-198, 606/155, 606/156
• US Class Current: 623/1.15
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2002/047 Urethrae
• 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 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: F16K 31/003 operated without a stable intermediate position, e.g. with snap action F16K31/56 takes precedence

Abstract

The present invention is directed to bistable cells and their use in devices, particularly medical devices such as stents, clamps and valves. An expandable stent formed of a plurality of bistable cells is described. The stent has two or more stable configurations, including a first stable configuration with a first diameter and a second stable configuration with a second, larger diameter. A valve comprising a bistable cell for use in eliminating incontinence is also disclosed.

Claims

1. A stent having a plurality of stable configurations, the stent comprising a plurality of interconnected cells, each cell having a cell structure that comprises a first section having first and second ends that are coupled to a second section, the second section being thinner and more flexible than the first section, the second section being configured to transition between and be stable in only a fully collapsed configuration and a fully expanded configuration so that each cell is capable of assuming either one of only two stable configurations.

2. The stent of claim 1, wherein a first subset of the plurality of interconnected cells comprise second sections exhibiting a first rigidity and a second subset of the plurality of interconnected cells comprise second sections exhibiting a second rigidity, wherein the first rigidity differs from the second rigidity.

3. The stent of claim 2, wherein a first stable configuration of a cell structure is an unexpanded configuration and a second stable configuration of a cell structure is a fully expanded configuration.

4. The stent of claim 2, wherein the first and second subsets of the plurality of interconnected cells are designed and arranged to provide a range of stent diameters in step-wise fashion.

5. The stent of claim 1, wherein the plurality of interconnected cells are constructed and arranged so that the cells may be switched between the two stable configurations by applying a uniform radially directed force to an interior or an exterior surface of the stent.

6. The stent of claim 5, wherein, when the cells are switched between the two stable configurations, at least one of the cells passes through a transition point between the two stable configurations that allows the force to be decreased.

7. The stent of claim 5, wherein, when the cells are switched between the two stable configurations, at least one of the cells passes through a transition point between the two stable configurations that allows the force to be decreased to zero.

8. The stent of claim 1, wherein the first and second sections have a generally wave-like shape, and the cell is capable of assuming only a first stable state and a second stable state.

9. The stent of claim 8, wherein the first section is generally in phase with the second section in the first stable state, and the first section is generally out of phase with the second section in the second stable state.

10. The stent of claim 8, wherein the cell is capable of isothermally expanding from the first stable state to the second stable state.

11. The stent of claim 1, wherein each cell has a first stable state and a second stable state, and at least a portion of the second section of at least one cell changes from a generally concave shape to a generally convex shape or from a generally convex shape to a generally concave shape when the cell changes from the first stable state to the second stable state.

12. The stent of claim 1, wherein at least one of the first and second sections comprises an arcuate shape.

13. The stent of claim 1, wherein the second section of at least one cell comprises a plurality of generally rigid interconnected members.

14. The stent of claim 1, wherein the second section of at least one cell comprises one or more hinges.

15. The stent of claim 1, wherein the second section of at least one cell comprises three generally linear portions, the three generally linear portions cumulatively forming either a generally concave shape or a generally convex shape.

16. The stent of claim 1, wherein at least some of the cells are interconnected with one or more flexibility joints.

17. A tubular stent having a surface comprising a plurality of cells, each cell having a first stable shape and a second stable shape, the second stable shape encompassing a larger area than the first stable shape, each cell comprising first and second interconnected sections, the second section more flexible than the first section, wherein each cell is capable of assuming at least one of the first and second stable shapes, and all shapes between the first and the second stable shapes are unstable.

18. The stent of claim 17, wherein a first subset of the plurality of cells exhibit a first rigidity and a second subset of the plurality of cells exhibit a second rigidity, wherein the first rigidity differs from the second rigidity.

19. The stent of claim 18, wherein a first stable shape of a cell structure is an unexpanded shape and a second stable shape of a cell structure is a fully expanded shape.

20. The stent of claim 18, wherein the first and second subsets of the plurality of cells are designed and arranged to provide a range of stent diameters in step-wise fashion.

21. The stent of claim 17, wherein the plurality of cells are constructed and arranged so that the cells may be switched between the two stable shapes by applying a uniform radially directed force to an interior or an exterior surface of the stent.

22. The stent of claim 17, wherein at least some of the cells are interconnected with one or more flexibility joints.

23. An expandable device comprising:

one or more unit cells, each unit cell of the expandable device having a plurality of stable collapsed configurations and a plurality of stable expanded configurations;

wherein;

one or more of the unit cells comprises a thin strut and a thick strut, the thick strut having a thickness that is greater than a thickness of the thin strut, the thin strut configured to transition between at least a stable collapsed configuration and a stable expanded configuration; and

each unit cell is adapted to be expanded initially from a first stable collapsed state upon application of outward force to a transition point beyond which each unit cell is adapted to be further expanded to a first stable expanded configuration by a force that is less than the initial force applied to expand the unit cell from the first stable collapsed configuration to the transition point.

24. The expandable device of claim 23, wherein each cell comprises a rigid segment coupled to a flexible segment.

25. The expandable device of claim 23, wherein each cell comprises a first arcuate member having first and second ends and a second arcuate member having first and second ends, the first end of the first member being in communication with the first end of the second member, and the second end of the first member being in communication with the second end of the second member.

26. The expandable device of claim 23, wherein the one or more unit cells comprises more than one type of cell, each type of cell having a different spring constant, each spring constant causing the expandable device to assume a different diameter according to the amount of the applied uniform radially directed force.

27. The expandable device of claim 23, wherein at least one of the one or more unit cells has an equilibrium center position and an asymmetrical force-displacement characteristic around the equilibrium center position, and wherein the first stable expanded configuration of the at least one of the one or more unit cells is more stable than the first stable collapsed configuration of the at least one of the one or more unit cells.

28. The expandable device of claim 23, wherein the expandable device is selected from the group consisting of a stent, a bistable valve, an expander, a clip, a loop, and a ring.

29. The expandable device of claim 23, wherein the expandable device comprises nitinol.

30. The expandable device of claim 23, comprising two or more unit cells interconnected with one or more flexibility joints.

31. An expandable device comprising one or more unit cells, each of the one or more unit cells having a first stable state and a second stable state, wherein:

an area of each cell is larger in the second stable state than in the first stable state;

each cell is characterized by a negative spring rate such that, without requiring the device to absorb heat, a force needed to further expand each unit cell toward the second stable state decreases as the amount of displacement of the unit cell from the first stable state toward the second stable state increases beyond an equilibrium diameter; and

the cells are constructed such that the expandable device has a plurality of stable states.

32. The expandable device of claim 31, wherein at least one of the one or more unit cells has at least one of a plurality of stable collapsed configurations and a plurality of stable expanded configurations.

33. The expandable device of claim 31, wherein the expandable device has only one unit cell.

34. The expandable device of claim 31, wherein each cell comprises a first arcuate member having first and second ends and a second arcuate member having first and second ends, the first end of the first member is in communication with the first end of the second member, and the second end of the first member is in communication with the second end of the second member.

35. The expandable device of claim 31, wherein the one or more unit cells are constructed and arranged so that the expandable device may be switched between at least two stable states by applying a uniform radially directed force to the expandable device.

36. The expandable device of claim 31, comprising more than one type of cell, each type of cell having a different spring constant, each spring constant causing the expandable device to assume a different diameter according to the amount of the applied uniform radially directed force.

37. The expandable device of claim 31, wherein the first stable state is a compressed state and the second stable state is an expanded state, wherein each of the one or more unit cells has an equilibrium center position and an asymmetrical force-displacement characteristic around the equilibrium center position, and wherein the expanded state is the most stable state of each unit cell.

38. The expandable device of claim 31, wherein the expandable device is selected from the group consisting of a stent, a bistable valve, an expander, a clip, a loop, and a ring.

39. The expandable device of claim 31, comprising two or more unit cells interconnected with one or more flexibility joints.