Axially nested slide and lock expandable device

• US 20070032857A1
• Filed: 08/02/2005
• Published: 02/08/2007
• Est. Priority Date: 08/02/2005
• Status: Active Grant

• Current Assignee: REVA Medical Inc.
• Original Assignee: REVA Medical Inc.
• Inventors: Nguyen, John, Padilla, Orlando, Morris, Andrew, Moore, Daniel, Schmid, Eric, Jackson, Thomas
• Granted Patent: US 7,914,574 B2
• Time in Patent Office: Days
• US Class Current: 623/1.160
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

The invention relates generally to expandable medical implants for maintaining support of a body lumen and, in particular, to an axially nested, diametrically expandable, slide and lock vascular device for enlarging an occluded portion of a vessel. The axially nested vascular device desirably achieves both competitive crossing profiles while maintaining other key features, such as, for example, radial strength and luminal patency. The collapsed profile can also be made very thin without compromising radial strength. Thus, the vascular device can advantageously be deployed in small and difficult to reach areas or vessels. The axial nesting substantially eliminates radial overlap between mating structural elements thereby desirably allowing for a low, uniform profile.

Claims

1. A slide-and-lock stent, comprising:

a tubular member that is expandable from a collapsed state to an expanded state;

the tubular member comprising at least one slide-and-lock section;

the slide-and-lock section comprising separate first and second axially nested, slidably coupled structural elements, at least one of which comprises a deflectable structure configured to deflect during expansion from the collapsed state to the expanded state, thereby resisting recoil, and wherein no portion of either structural elements weaves through paired slots in the other structural element.

2. The slide-and-lock stent of claim 1, wherein the deflectable structure is configured to deflect axially.

3. The slide-and-lock stent of claim 1, wherein the deflectable structure is configured to deflect radially.

4. The slide-and-lock stent of claim 1, wherein the first structural element comprises a rib with an axially extending tooth.

5. The slide-and-lock stent of claim 2, wherein the second structural element comprises a rib with a plurality of axially extending teeth which engage the axially extending tooth of the rib of the first structural element during expansion so that at least one of the ribs is deflected.

6. The slide-and-lock stent of claim 5, wherein the rib of the first structural element comprises a plurality of teeth which engage the teeth of the rib of the second structural element during expansion so that at least one of the ribs is axially deflected.

7. The slide-and-lock stent of claim 5, wherein the second structural element comprises a rib with a plurality of axially extending teeth which engage the axially extending tooth of the rib of the first structural element during expansion so that at least one of the ribs is radially deflected.

8. The slide-and-lock stent of claim 5, wherein the teeth of the rib of the second structural element are arranged in a staggered pattern.

9. The slide-and-lock stent of claim 1, wherein the stent further comprises at least one more slide-and-lock section.

10. The slide-and-lock stent of claim 9, wherein the slide-and-lock sections are substantially identical to one another.

11. The slide-and-lock stent of claim 9, wherein the slide-and-lock sections are different from one another.

12. The slide-and-lock stent of claim 9, wherein the stent further comprises at least one flexible linkage section connecting adjacent slide-and-lock sections to facilitate the elastic deflection.

13. The slide-and-lock stent of claim 1, wherein the stent comprises a biocompatible material.

14. The slide-and-lock stent of claim 13, wherein the stent comprises a bioresorbable polymer.

15. The slide-and-lock stent of claim 1, wherein the stent comprises a therapeutic agent.

16. The slide-and-lock stent of claim 15, wherein the therapeutic agent comprises a pharmaceutical agent.

17. The slide-and-lock stent of claim 15, wherein the therapeutic agent comprises a biological agent.

18. The slide-and-lock stent of claim 1, wherein the stent comprises a radiopaque material.

19. The slide-and-lock stent of claim 1, wherein the recoil is less than about 5%.

20. The slide-and-lock stent of claim 1, wherein a lock-out mechanism controls the maximum stent expansion.

66. The slide-and-lock stent of claims 1, 21 or 42, wherein the stent further comprises a polymeric sheath.

67. A system for treating a site within a vessel, comprising a catheter having a deployment means, and any stent of claims 1, 21 or 42, wherein said catheter is adapted to deliver the stent to said site and said deployment means is adapted to deploy the stent.

68. The system of claim 67, wherein said catheter is selected from the group consisting of over-the-wire catheters, coaxial rapid-exchange catheters, and multi-exchange delivery catheters.

69. A method for re-treatment of a body lumen, comprising the steps of:

deploying to a region of said body lumen any stent of claims 1, 21 or 42, wherein said stent is made from a bioresorbable polymer, and resides at said region for a period of time; and

administering to said region, after the period of time, a second treatment.

21. A slide-and-lock stent, comprising:

a tubular member that is expandable from a collapsed diameter to an expanded diameter;

the tubular member comprising a first circumferential slide-and-lock section and a second circumferential slide-and-lock section, said slide-and-lock sections being longitudinally arranged and linked;

each of the slide-and-lock sections comprising a first axial element and a second axial element wherein the first and second axial elements are axially offset and connected by an interlocking mechanism;

wherein the first axial element comprises a first rib with at least one axially outwardly extending tooth and the second axial element comprises a second rib with at least one axially inwardly extending tooth; and

wherein the outwardly and inwardly extending teeth engaging one another during expansion and are configured to permit one-way sliding between the first and second axial elements such that at least one of the first and second ribs is axially deflected during expansion from the collapsed diameter to the expanded diameter.

22. The slide-and-lock stent of claim 21, wherein the tubular member comprises a lumen and the interlocking mechanism between the axial elements substantially eliminates radial overlap and allows for a substantially clear lumen such that substantially no structure protrudes into the lumen.

23. The slide-and-lock stent of claim 21, wherein said slide-and-lock sections are connected by a linkage section that comprises at least one flexible element.

24. The slide-and-lock stent of claim 21, wherein the at least one tooth of the first and/or second ribs has a tapered engaging surface and a flat end surface to facilitate one-way sliding.

25. The slide-and-lock stent of claim 21, wherein the stent further comprises a capture mechanism configured to control stent profile during expansion.

26. The slide-and-lock stent of claim 25, wherein the capture mechanism comprises a capture strap.

27. The slide-and-lock stent of claim 25, wherein the capture mechanism inhibits the first and/or second ribs from jumping out of a predetermined track during stent expansion.

28. The slide-and-lock stent of claim 21, wherein the stent further comprises a capture mechanism configured to control stent profile when the stent is in the collapsed diameter.

29. The slide-and-lock stent of claim 28, wherein the capture mechanism comprises a capture strap.

30. The slide-and-lock stent of claim 21, wherein at least one of the first or second ribs comprises a groove that engages the at least one tooth from the other rib, wherein such engagement substantially prevents the ribs from substantially deviating from a predetermined path.

31. The slide-and-lock stent of claim 21, wherein the maximum stent expansion is controlled by a lock-out mechanism.

32. The slide-and-lock stent of claim 31, wherein the lock-out mechanism comprises a tongue and groove arrangement.

33. The slide-and-lock stent of claim 21, wherein the corresponding axial elements of each slide-and-lock section are radially offset.

34. The slide-and-lock stent of claim 21, wherein each of the second ribs comprises a plurality of engaging teeth.

35. The slide-and-lock stent of claim 34, wherein each of the first ribs comprises a plurality of engaging teeth.

36. The slide-and-lock stent of claim 21, wherein each of the second axial elements comprises two ribs with engaging teeth.

37. The slide-and-lock stent of claim 36, wherein each of the first axial elements comprises two ribs with engaging teeth.

38. The slide-and-lock stent of claim 21, wherein each of the second ribs comprises a plurality of spaced deflectable fingers that each comprise a plurality of teeth that engage the corresponding first rib during expansion.

39. The slide-and-lock stent of claim 38, wherein each of the second axial elements comprises an additional rib that comprises a plurality of spaced deflectable fingers that each comprise a plurality of teeth that engage the corresponding first rib during expansion.

40. The slide-and-lock stent of claim 39, wherein the teeth each of the second axial elements are arranged in an alternating repetitive pattern.

41. The slide-and-lock stent of claim 39, wherein the deflectable fingers of each second axial element are arranged in a staggered pattern.

42. A slide-and-lock stent, comprising:

a tubular member that is expandable from a first diameter to a second diameter;

the tubular member comprising a first circumferential section and a second circumferential section with said circumferential sections being longitudinally arranged;

a flexible linkage section connecting said circumferential sections;

each of the circumferential sections comprising a first slide-and-lock element and a second slide-and-lock element with the corresponding slide-and-lock elements of each circumferential section being radially connected by a slidable articulating mechanism;

each of the first slide-and-lock elements comprising at least one tooth and each of the second slide-and-lock elements comprising at least one radially extending tooth; and

during expansion, the teeth of the first slide-and-lock elements engaging corresponding radially extending teeth of the second slide and lock sections, said teeth being configured to permit one-way sliding between the corresponding first and second slide-and-lock elements such that at least a portion of the corresponding first and second slide-and-lock elements is radially deflected during expansion from the first diameter to the second diameter.

43. The slide-and-lock stent of claim 42, wherein the first slide-and-lock-elements and the corresponding second slide-and-lock elements are axially nested to substantially eliminate radial overlap between mating slide-and-lock elements thereby allowing for a substantially uniform thickness profile when the stent is expanded to the second diameter.

44. The slide-and-lock stent of claim 42, wherein the tubular member comprises a lumen and the interlocking between the corresponding slide-and-lock elements substantially eliminates radial overlap and allows for a substantially clear through-lumen such that substantially no structure protrudes into the lumen when the stent is expanded to the second diameter.

45. The slide-and-lock stent of claim 42, wherein the radially extending teeth comprise radially outwardly extending teeth.

46. The slide-and-lock stent of claim 42, wherein at least one of the second slide-and-lock elements comprise a plurality of radially extending teeth

47. The slide-and-lock stent of claim 42, wherein at least one of the second slide-and-lock elements comprises two spaced ribs and each rib comprises a plurality of radially extending teeth.

48. The slide-and-lock stent of claim 42, wherein at least one of the first slide-and-lock elements comprises a rib that comprises a pair of axially extending teeth that engage the corresponding plurality of radially extending teeth on corresponding ribs of the corresponding second slide-and-lock element during expansion to the second diameter.

49. The slide-and-lock stent of claim 42, wherein at least one of the first slide-and-lock elements includes a plurality of radially extending teeth that engage a corresponding plurality of radially extending teeth of at least one of the second slide-and-lock elements during expansion to the second diameter.

50. The slide-and-lock stent of claim 42, wherein the linkage section comprises at least one spring element.

51. The slide-and-lock stent of claim 42, wherein the stent further comprises a hard stop to control maximum stent expansion.

52. The slide-and-lock stent of claim 42, wherein the stent further comprises a raised shielding and alignment strap to provide additional strength and facilitate a curved structure.

53. The slide-and-lock stent of claim 42, wherein the stent comprises a metal or alloy.

54. The slide-and-lock stent of claim 42, wherein the stent comprises at least two materials.

55. The slide-and-lock stent of claim 54, wherein the stent comprises a metal and a polymer.

56. The slide-and-lock stent of claim 42, wherein the stent comprises a polymeric material.

57. The slide-and-lock stent of claim 56, wherein the stent comprises a bio-resorbable material.

58. The slide-and-lock stent of claim 57, wherein the stent comprises a bio-erodible material.

59. The slide-and-lock stent of claim 57, wherein the stent comprises a bio-degradable material.

60. The slide-and-lock stent of claim 56, wherein the stent comprises a bio-stable material.

61. The slide-and-lock stent of claim 60, wherein the stent comprises a non-degrading material.

62. The slide-and-lock stent of claim 60 wherein the stent comprises a non-erodible material.

63. The slide-and-lock stent of claim 42, wherein the stent is fabricated by a lamination process.

64. The slide-and-lock stent of claim 62 wherein the stent is fabricated by a laser cutting process.

65. The slide-and-lock stent of claim 42, wherein the stent further comprises a coating to alter a physical characteristic of the stent.