Expandable device having bistable spring construction

• US 7,758,628 B2
• Filed: 02/18/2004
• Issued: 07/20/2010
• Est. Priority Date: 01/24/1997
• Status: Expired due to Term

• Current Assignee: CeloNova Stent, Inc.
• Original Assignee: Nexeon MedSystems, Inc.
• Inventors: Besselink, Petrus A.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/782,266
• Publication Number:
  US 20040193247A1
• Time in Patent Office: 2,344 Days
• Field of Search: 623 111- 154, 606/194, 606/200, 606/191, 606/198
• 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 method of applying a radial force against a surface of a passageway with an expandable device, comprising:

providing an expandable device with a plurality of cells comprising a generally longitudinal wave-like first member and a generally longitudinal wave-like second member, at least one cell capable of being expanded between a stable contracted state in which the first and second members are generally in phase and at least one stable expanded state in which the first and second members are generally out of phase;

radially expanding the expandable device to expand the plurality of cells to a transition point defining a geometry of the plurality of cells at which no additional force is necessary to further expand the plurality of cells; and

permitting the plurality of cells to continue to expand beyond the transition point to the at least one expanded state without the application of additional force so that the expandable device expands against a surface of the passageway;

wherein;

one of the first and second members substantially retains its shape when the cell transitions from the contracted to the at least one expanded shape.

2. The method as recited in claim 1, wherein the step of radially expanding comprises expanding the plurality of cells without substantial axial shortening of the expandable device.

3. The method as recited in claim 1, wherein the expandable device comprises a tubular member.

4. The method as recited in claim 1, wherein the expandable device comprises a liner.

5. The method as recited in claim 1, wherein the expandable device comprises thick struts coupled to thin struts.

6. The method as recited in claim 1, further comprising inserting a portion of the expandable device into a body of a patient.

7. The method as recited in claim 1, wherein at least one cell is capable of being expanded between a stable contracted state and a stable expanded state without any stable configurations between the stable contracted state and the stable expanded state.

8. The method as recited in claim 1, wherein one of the first and second members is generally flexible and the other of the first and second members is generally rigid.

9. The method as recited in claim 1, wherein the expandable device is a stent.

19. The method as recited in claim 1, wherein the first arcuate member is generally flexible and the second arcuate member is generally rigid.

10. A method of stabilizing an unsupported section of a passageway, comprising:

providing an expandable device having one or more cells, each of the cells comprising first and second arcuate members;

placing the device at a position in the passageway while in a first stable state;

applying a radially outward force to the expandable device to expand the one or more cells to a transition point defining a geometry of the one or more cells at which no additional force is necessary to further expand the one or more cells; and

permitting the one or more cells to continue to expand beyond the transition point without the application of additional force;

wherein at least a portion of the first arcuate member changes from a generally concave shape to a generally convex shape when the one or more cells expand beyond the transition point.

11. The method as recited in claim 10, further comprising attaching a wrapping to the outer surface of the device.

12. The method as recited in claim 11, wherein attaching comprises attaching an expandable material.

13. The method as recited in claim 10, further comprising applying a deformable material to the outer surface of the device.

14. The method as recited in claim 13, wherein applying comprises applying an elastomeric material.

15. The method as recited in claim 10, further comprising expanding the device to a first stable size and a second stable size.

16. The method as recited in claim 10, further comprising inserting a portion of the expandable device into a body of a patient.

17. The method as recited in claim 10, wherein the device has a generally tubular shape.

18. The method as recited in claim 10, wherein the device is a single unit cell device.

20. The method as recited in claim 10, wherein the expandable device is a stent.

21. A method of isolating a portion of a passageway, comprising:

inserting within the passageway an expandable multistable device formed by one or more of cells that permit the expandable device to be selectively actuated between a contracted state and at least one expanded state, each of the cells comprising first and second wave-like portions;

expanding the one or more cells from a stable collapsed configuration in which the first and second wave-like portions are in phase to a transition point defining a geometry of the one or more cells at which no additional force is necessary to further expand the one or more cells;

permitting the one or more cells to continue to expand beyond the transition point to a stable expanded configuration without the application of additional force, in which the first and second wave-like portions are out of phase, wherein there are no stable configurations between the stable collapsed configuration and the stable expanded configuration; and

isolating a portion of the passageway with the expandable device.

22. The method as recited in claim 21, wherein the first and second wave-like portions each comprise a wave shape in the contracted state.

23. The method as recited in claim 21, wherein the step of expanding occurs without substantial axial shortening of the expandable multistable device.

24. The method as recited in claim 21, wherein the first wave-like portion is more flexible than the second wave-like portion.

25. The method as recited in claim 21, wherein the passageway is in a body of a patient.

26. The method as recited in claim 21, wherein the expandable multistable device is a stent.

27. A method of expanding an expandable device in a passage way, comprising:

providing an expandable device having at least one cell, the at least one cell comprising first and second members, at least a portion of the second member(s) being more pliable than the first member(s);

positioning the expandable device in a passage way;

applying a radially outward force to the expandable device to expand the at least one cell to a transition point of the at least one cell defining a geometry of the at least one cell beyond which no additional force is needed to further expand the least one cell, at least a portion of the at least one cell moving between a generally concave state and a generally convex state at the transition point; and

permitting the at least one cell to continue to expand beyond the transition point without the application of additional force.

28. The method as recited in claim 27, wherein the first member comprises a thin strut and the second arcuate member is a thick strut.

29. The method as recited in claim 27, wherein each of the second members comprise a wave shape in the first stable position.

30. The method as recited in claim 27, wherein the step of expanding comprises expanding the expandable device radially outward.

31. The method as recited in claim 27, wherein the expandable device is a medical device.

32. The method as recited in claim 27, further comprising inserting a portion of the expandable device into a body of a patient.

33. The method as recited in claim 27, wherein each cell is capable of assuming a stable collapsed configuration and a stable expanded configuration without any stable configurations between the stable collapsed configuration and the stable expanded configuration.

34. The method as recited in claim 27, wherein at least one of the first and second members comprises an arcuate shape.

35. The method as recited in claim 34, wherein at least one second member comprises a plurality of generally rigid interconnected members.

36. The method as recited in claim 27, wherein at least one second member comprises one or more hinges.

37. The method as recited in claim 27, wherein at least one second member comprises three generally linear portions, the three generally linear portions cumulatively forming either a generally concave shape or a generally convex shape.

38. The method as recited in claim 27, wherein at least one second member comprises a plurality of generally rigid interconnected members.

39. The method as recited in claim 27, wherein each cell is capable of isothermally expanding to a stable expanded configuration in which the first and second arcuate members are out of phase.

40. The method as recited in claim 27, wherein the expandable device is a stent.