Expandable, intraluminal stents

• US 5,702,419 A
• Filed: 09/21/1994
• Issued: 12/30/1997
• Est. Priority Date: 09/21/1994
• Status: Expired due to Fees

• Current Assignee: Wake Forest University Health Sciences
• Original Assignee: Wake Forest University
• Inventors: Ferrario, Carlos M., Berry, Joel L., Newman, Virginia S., Dean, Richard H.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/309,359
• Time in Patent Office: 1,196 Days
• Field of Search: 606/190, 606/191, 606/194, 606/195, 606/198, 606/108, 623/1, 623/11, 623/12
• US Class Current: 623/1.13
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

An expandable, intraluminal stent is provided which can be inserted into a body passage, and is capable of supporting an intact vascular graft. The stent is a thin-walled, generally tubular member having a plurality of rigid support tabs spaced uniformly around the perimeter of the two ends of the stent. A plurality of spacer bars span longitudinally between the rigid support tabs at one end of the stent and corresponding rigid support tabs at the other end. The spacer bars serve as struts to prevent longitudinal expansion or contraction of the stent so that the length of the stent is maintained. Plastically deformable connecting links interconnect adjacent rigid support tabs around each end of the stent to enable the stent to be expanded to an enlarged diameter. The stent can be expanded with a delivery system which applies a radially, outwardly extending force from the exterior of the stent. Alternatively, the stent can be expanded using an angioplasty balloon.

Claims

1. An expandable, generally tubular, intraluminal stent comprising:

a) a plurality of rigid end supports disposed in a first ring at a first end of the tubular stent and in a second ring at a second end of the stent;

b) a plurality of rigid struts for connecting the end supports in the first ring with the end supports in the second ring to inhibit relative longitudinal displacement between end supports at opposite ends of the stent; and

c) a plurality of deformable connecting links linking adjacent end supports in the first ring and adjacent end supports in the second ring so that the stent may be radially expanded from a first smaller diameter to a second larger diameter.

2. The stent in accordance with claim 1 wherein said struts include rigid spacer bars having a first end connected with a rigid end support at the first end of the stent and a second end connected with a rigid end support at the second end of the stent.

3. The stent in accordance with claim 1 wherein the rigid end supports in the first ring are disposed so that each end support in the first ring is positioned diametrically opposed to another one of the end supports in the first ring and the rigid end supports in the second ring are disposed so that each end supports in the second ring is positioned diametrically opposed to another one of the end supports in the second ring.

4. The stent in accordance with claim 1 wherein all of the rigid end supports in the first ring are linked together by said deformable connecting links and all of the rigid end supports in the second ring are linked together by said deformable connecting links.

5. The stent in accordance with claim 1 wherein all of the rigid end supports in the first ring are connected with corresponding end supports in the second ring by the rigid struts.

6. The stent in accordance with claim 5 wherein all of the rigid end supports in the first ring are linked together by said deformable connecting links and all of the rigid end supports in the second ring are linked together by said deformable connecting links.

7. The stent in accordance with claim 1 comprising external expansion couplings mounted to an exterior surface of the struts to enable the stent to be radially expanded from an exterior surface of the stent.

8. The stent in accordance with claim 7 wherein the stent includes a central lumen and a vein segment lining the central lumen of the stent.

9. The stent in accordance with claim 8 wherein the vein segment is longer than the stent and ends of the vein segment are everted over the exterior surface of the stent.

10. The stent in accordance with claim 8 wherein the vein segment includes a synthetic graft material.

11. The stent in accordance with claim 8 wherein the vein segment includes an autologous vein.

12. The stent in accordance with claim 7 wherein the external expansion couplings include coupling tubes mounted to the exterior of the struts with the coupling tubes extending in a longitudinal direction of the stent.

13. The stent in accordance with claim 12 wherein the coupling tubes are fixed to the struts.

14. The stent in accordance with claim 1 wherein the end supports include thin, generally arcuate support tabs.

15. The stent in accordance with claim 14 wherein the arcuate support tabs have a radius of curvature that equals a radius of curvature of the stent when in the first diameter.

16. The stent in accordance with claim 15 wherein each ring includes six support tabs.

17. The stent in accordance with claim 1 wherein the deformable connecting links link adjacent end supports in each respective ring and the rigid struts connect end supports at the first end of the stent to corresponding end supports at the second end of the stent so that open areas are formed in the tubular stent between a pair of adjacent end supports and a respective connecting link at the first end of the stent and a pair of adjacent end supports and a respective connecting link at the second end of the stent and between a pair of adjacent struts connecting the pair of end supports at the first end of the stent to the corresponding pair of end supports at the second end of the stent.

18. The stent in accordance with claim 1 wherein the deformable connecting links link adjacent end supports in each respective ring and the rigid struts connect end supports at the first end of the stent to corresponding end supports at the second end of the stent so that open areas are formed in the tubular stent between the ring of end supports and connecting links at the first end of the stent and the end supports and connecting links at the second end of the stent and between adjacent rigid struts connecting the ring of end supports at the first end of the stent with the ring of end supports at the second end of the stent.

19. The stent in accordance with claim 18 wherein each of the open areas extends generally from the first end of the stent to the second end of the stent when in the second enlarged diameter.

20. The stent in accordance with claim 18 wherein the open areas extend at least over half the longitudinal length of the stent.

21. The stent in accordance with claim 1 wherein the tubular stent has a surface area and the surface area of the tubular stent is at least 70% open.

22. The stent in accordance with claim 21 wherein the surface area of the stent is at least 80% open.

23. The stent in accordance with claim 1 wherein said struts include external expansion couplings having a first end connected with a rigid end support at the first end of the stent and a second end connected with a rigid end support at the second end of the stent.

24. The stent in accordance with claim 23 wherein the external expansion couplings include coupling tubes.

25. The stent in accordance with claim 1 comprising external expansion couplings mounted to an exterior surface of the rigid end supports to enable the stent to be radially expanded from an exterior surface of the stent.

26. The stent in accordance with claim 25 wherein the stent includes a central lumen and a vein segment lining the central lumen of the stent.

27. The stent in accordance with claim 26 wherein the vein segment is longer than the stent and ends of the vein segment are everted over the exterior surface of the stent.

28. The stent in accordance with claim 25 wherein the external expansion couplings include coupling tubes mounted to the exterior of the rigid end supports with the coupling tubes extending in a longitudinal direction of the stent.

29. An expandable stent comprising:

a) a generally thin-walled, tubular structure having a central lumen, the tubular structure having a first smaller diameter to enable delivery of the tubular structure into a selected body passageway having a lumen and a second enlarged diameter for retaining the tubular structure in the lumen of the body passageway upon application of an outward radial force on the tubular structure; and

b) external expansion couplings mounted on an exterior surface of the tubular structure for enabling the outward radial force to be applied externally of the tubular structure via the external expansion couplings, the external expansion couplings being arranged such that a first external expansion coupling is generally diametrically opposed to a second external expansion coupling.

30. The stent in accordance with claim 29 wherein the external expansion couplings include coupling tubes mounted at the exterior of the stent with the coupling tubes extending generally in a longitudinal direction of the tubular stent.

31. An expandable, intraluminal, vascular graft comprising:

a) a stent having a generally thin-walled, tubular structure with a central lumen, the tubular structure having a first smaller diameter to enable delivery of the tubular structure into a selected body passageway having a lumen and a second enlarged diameter upon application of an outward radial force on the tubular structure for retaining the tubular structure in the lumen of the body passageway, and external expansion couplings mounted on an exterior surface of the tubular structure for enabling the outward radial force to be applied externally of the tubular structure via the external expansion couplings, the external expansion couplings being arranged such that a first external expansion coupling is generally diametrically opposed to a second external expansion coupling; and

b) an endothelial layer lining the central lumen of the stent.

32. An expandable, intraluminal vascular graft comprising:

a) a stent having a generally thin-walled, tubular structure with a central lumen, the tubular structure having a first smaller diameter to enable delivery of the tubular structure into a selected body passageway having a lumen and a second enlarged diameter upon application of an outward radial force on the tubular structure for retaining the tubular structure in the lumen of the body passageway, and external expansion couplings mounted on an exterior surface of the tubular structure for enabling the outward radial force to be applied externally of the tubular structure via the external expansion couplings; and

b) an endothelial layer lining the central lumen of the stent, wherein the endothelial layer includes a vein segment.

33. The graft in accordance with claim 32 wherein the vein segment is longer than the stent and ends of the vein segment are everted over ends of the stent.

34. The graft in accordance with claim 32 wherein the vein segment includes an autologous vein.

68. The graft in accordance with claim 32 wherein the vein segment includes a synthetic graft material.

35. An expandable intraluminal stent comprising a generally thin-walled tubular structure having first and second ends and a central lumen, the tubular structure having a thin-walled lattice frame with openings in the frame, each of the openings extending longitudinally at least half the length of the tubular structure, the tubular structure being deformable from a first smaller diameter into a second enlarged diameter.

36. The stent in accordance with claim 35 wherein the tubular structure includes rigid components and deformable components interconnecting the rigid components, the deformable components deforming to enable the tubular structure to expand from the first smaller diameter into the second larger diameter.

37. The stent in accordance with claim 36 wherein the rigid components include a plurality of rigid end supports disposed in a ring at each end of the tubular stent, the end supports in each ring being generally uniformly spaced apart around each respective ring.

38. The stent in accordance with claim 37 wherein the deformable components include deformable connecting links linking adjacent end supports in each respective ring so that the stent may be radially expanded from the first smaller diameter to the second enlarged diameter.

39. An expandable intraluminal stent comprising a generally thin-walled tubular structure having first and second ends and a central lumen, the tubular structure having a thin-walled lattice frame with openings in the frame, each of the openings extending longitudinally at least half the length of the tubular structure, the tubular structure being deformable from a first smaller diameter into a second enlarged diameter, wherein the lattice frame is configured so that at least some of the openings extend generally from the lattice frame at the first end all the way to the lattice frame at the second end of the stent.

40. The stent in accordance with claim 39 wherein the lattice frame is configured so that all of the openings extend generally from the lattice frame at the first end all the way to the lattice frame at the second end of the stent.

41. An expandable intraluminal stent comprising a generally thin-walled tubular structure having first and second ends and a central lumen, the tubular structure having a thin-walled lattice frame with openings in the frame, each of the openings extending longitudinally at least half the length of the tubular structure, the tubular structure being deformable from a first smaller diameter into a second enlarged diameter, the tubular structure including rigid components and deformable components interconnecting the rigid components, the deformable components deforming to enable the tubular structure to expand from the first smaller diameter into the second larger diameter, the rigid components including a plurality of rigid end supports disposed in a ring at each end of the tubular stent, the end supports in each ring being generally uniformly spaced apart around each respective ring, wherein the rigid components include a plurality of rigid struts for connecting the ring of end supports at one end of the stent with the ring of end supports at the other end of the stent to inhibit relative longitudinal displacement between the rings of end supports at opposite ends of the stent.

42. The stent in accordance with claim 41 wherein each strut extends generally from a respective one of the end supports at one end of the stent to a corresponding end support at the other end of the stent.

43. An expandable, generally tubular, intraluminal stent comprising:

a) a plurality of rigid end supports disposed in a ring at each end of the tubular stent, the end supports in each ring being generally uniformly spaced apart around each respective ring;

b) a plurality of rigid struts for connecting the ring of end supports at one end of the stent with the ring of end supports at the other end of the stent, each strut extending generally from a respective one of the end supports at one end of the stent to a corresponding end support at the other end of the stent to inhibit relative longitudinal displacement between corresponding end supports at opposite ends of the stent; and

c) a plurality of deformable connecting links linking adjacent end supports in each respective ring so that the stent may be radially expanded from a first smaller diameter enabling delivery of the stent into a selected body passageway having a lumen into a second enlarged diameter for positioning the stent in the lumen of the body passageway.

44. The stent in accordance with claim 43 wherein said struts include rigid spacer bars having a first end connected with a rigid end support at one end of the stent and a second end connected with a rigid end support at the other end of the stent.

45. The stent in accordance with claim 43 wherein the rigid end supports are disposed in the respective ring so that each end support is positioned diametrically opposed to another one of the end supports in the ring.

46. The stent in accordance with claim 43 wherein all of the rigid end supports in a respective ring are linked together by said deformable connecting links.

47. The stent in accordance with claim 43 wherein all of the rigid end supports in one of the rings are connected with corresponding end supports in the other ring by the rigid struts.

48. The stent in accordance with claim 43 comprising external expansion couplings mounted to an exterior surface of the struts to enable the stent to be radially expanded from the exterior of the stent.

49. The stent in accordance with claim 48 wherein the expansion couplings include coupling tubes mounted to the exterior of the struts.

50. The stent in accordance with claim 48 wherein the stent includes a central lumen and a vein segment lining the central lumen of the stent.

51. The stent in accordance with claim 50 wherein the vein segment is longer than the stent and ends of the vein segment are everted over ends of the stent.

52. The stent in accordance with claim 50 wherein the vein segment includes a synthetic graft material.

53. The stent in accordance with claim 50 wherein the vein segment includes an autologous vein.

54. The stent in accordance with claim 48 wherein the external expansion couplings include coupling tubes mounted to the exterior of the struts with the coupling tubes extending in a longitudinal direction of the stent.

55. The stent in accordance with claim 43 wherein the end supports include thin, generally arcuate support tabs.

56. The stent in accordance with claim 43 wherein the deformable connecting links link adjacent end supports in each respective ring and the rigid struts connect end supports at one end of the stent to corresponding end supports at the other end of the stent so that open areas are formed in the tubular stent between the ring of end supports and connecting links at one end of the stent and the end supports and connecting links at the other end of the stent and between adjacent rigid struts connecting the end supports at the one end of the stent with the end supports at the other end of the stent.

57. The stent in accordance with claim 56 wherein each of the open areas extends generally from one end of the stent to the other end of the stent when in the second enlarged diameter.

58. The stent in accordance with claim 56 wherein the open areas extend at least over half the longitudinal length of the stent.

59. The stent in accordance with claim 43 wherein said struts include external expansion couplings having a first end connected with a rigid end support at one end of the stent and a second end connected with a rigid end support at the other end of the stent.

60. The stent in accordance with claim 59 wherein the external expansion couplings include coupling tubes.

61. The stent in accordance with claim 43 comprising external expansion couplings mounted to an exterior surface of the rigid end supports to enable the stent to be radially expanded from the exterior of the stent.

62. The stent in accordance with claim 61 wherein the expansion couplings include coupling tubes mounted to the exterior of the rigid end supports.

63. The stent in accordance with claim 61 wherein the stent includes a central lumen and a vein segment lining the central lumen of the stent.

64. The stent in accordance with claim 63 wherein the vein segment is longer than the stent and ends of the vein segment are everted over ends of the stent.

65. The stent in accordance with claim 61 wherein the external expansion couplings include coupling tubes mounted to the exterior of the rigid end supports with the coupling tubes extending in a longitudinal direction of the stent.

66. An expandable stent comprising a generally thin-walled, tubular structure having a central lumen, the tubular structure having a first smaller diameter to enable delivery of the tubular structure into a selected body passageway having a lumen and a second enlarged diameter for retaining the tubular structure in the lumen of the body passageway, the tubular structure having rigid, non-deformable components and deformable components interconnecting the rigid components, the deformable components deforming upon radial expansion of the tubular structure to the second enlarged diameter, wherein the rigid components and the deformable components have surface areas and the surface-area of the rigid components exceeds the surface area of the deformable components.

67. An expandable stent comprising a generally thin-walled, tubular structure having a central lumen, the tubular structure having a first smaller diameter to enable delivery of the tubular structure into a selected body passageway having a lumen and a second enlarged diameter for retaining the tubular structure in the lumen of the body passageway, the tubular structure having rigid, non-deformable components and deformable components interconnecting the rigid components, the deformable components deforming upon radial expansion of the tubular structure to the second enlarged diameter, wherein the deformable components are disposed generally only at both ends of the tubular structure.