Apparatus having variable strut length and methods of use

• US 9,101,503 B2
• Filed: 03/06/2008
• Issued: 08/11/2015
• Est. Priority Date: 03/06/2008
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: JW Medical Systems Ltd
• Inventors: Lowe, David, Bonsignore, Craig, Snow, David W., Robinson, Timothy, Wiesman, Joshua P., Henderson, Dawn, Maier, Nathan
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/043,513
• Publication Number:
  US 20090228088A1
• Time in Patent Office: 2,714 Days
• Field of Search: 623 115- 122
• US Class Current: 1/1
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• 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

Abstract

A tubular prosthesis has a plurality of tubular rings that are radially expandable from a contracted configuration to an expanded configuration. Each ring comprises a plurality of axially oriented struts that are interconnected so as to form a circumferential series of at least one high peak and at least one low peak. The high and low peaks have apices that are oriented in the same axial direction. The apices of the high and low peaks are also oriented in the same direction and the apices of the high peaks are axially offset from the apices of the low peaks. A bridge member couples a pair of adjacent tubular rings together. The bridge member has a first end connected to a first low peak in a first tubular ring and a second end connected to either a high or low peak in an adjacent tubular ring.

Claims

1. A tubular prosthesis comprising:

a plurality of tubular rings radially expandable from a contracted configuration to an expanded configuration, each ring comprising a plurality of axially oriented struts interconnected so as to form a plurality of high peaks and a plurality of low peaks, the plurality of high peaks and the plurality of low peaks being circumferentially arranged to form an alternating series of at least one high peak and at least one low peak, the high and low peaks having apices oriented in the same axial direction, the apices of the high peaks being axially offset from the apices of the low peaks, the apices of the high peaks being axially aligned with one another, the apices of low peaks being axially aligned with one another; and

at least one non-linear bridge member coupling each pair of adjacent tubular rings together, the at least one non-linear bridge member having a first end connected to a first low peak in a first tubular ring of a respective pair of adjacent tubular rings and a second end connected to a second low peak in a second tubular ring of the respective pair of adjacent tubular rings, and a non-linear intermediate portion extending between the first and second ends, wherein the non-linear intermediate portion includes a transverse portion extending in a direction perpendicular to a longitudinal axis of the tubular prosthesis when the prosthesis is in the contracted configuration,

wherein the apices of the high and low peaks in the first tubular ring are circumferentially offset from the apices of the high and low peaks in the second tubular ring such that the first low peak in the first tubular ring is circumferentially offset from the second low peak in the second tubular ring, and

wherein each and every bridge member of the prosthesis extends circumferentially between adjacent unconnected high peaks of the first and second adjacent tubular rings of the respective pair of adjacent tubular rings connected by the respective bridge member and extends a length greater than a circumferential distance between the respective adjacent unconnected high peaks of the respective pair of adjacent tubular rings such that the respective bridge member inhibits contact between and overlapping of the adjacent unconnected high peaks of the respective adjacent tubular rings during flexure of the tubular prosthesis in the contracted configuration,

wherein the non-linear bridge member includes a portion, between the first end and the second end, having a reduced thickness by curving inward on only one side to facilitate flexibility between the first and second tubular rings coupled with the non-linear bridge member.

2. The tubular prosthesis of claim 1, wherein each high peak comprises a long strut having a first length and each low peak comprises a short strut having a second length shorter than the first length.

3. The tubular prosthesis of claim 1, wherein the plurality of axially oriented struts comprise long struts and short struts, the short struts shorter than the long struts and wherein the plurality of axially oriented struts are arranged circumferentially such that each short strut is disposed between one long strut and one short strut.

4. The tubular prosthesis of claim 1, wherein the low and the high peaks are arranged circumferentially such that each high peak is disposed between one low peak and one high peak.

5. The tubular prosthesis of claim 1, wherein the apices of the high and low peaks of the first tubular ring point toward the apices of the high and low peaks of the second tubular ring.

6. The tubular prosthesis of claim 1, wherein the first low peak is circumferentially offset from the high peak in the second tubular ring.

7. The tubular prosthesis of claim 1, wherein each low peak comprises two short struts.

8. The tubular prosthesis of claim 1, wherein each high peak comprises one long strut and one short strut, the short strut shorter than the long strut.

9. The tubular prosthesis of claim 1, wherein each high peak comprises one long strut and one short strut, the long strut having a first width and the short strut having a second width less than the first.

10. The tubular prosthesis of claim 1, wherein the bridge member is sigmoidal shaped.

11. The tubular prosthesis of claim 1, wherein the bridge member has a z-shape.

12. The tubular prosthesis of claim 1, wherein the bridge member comprises a surface defining one or more apertures therein.

13. The tubular prosthesis of claim 12, wherein the apertures extend entirely through the bridge member.

14. The tubular prosthesis of claim 12, wherein the apertures have an axis parallel to an outer surface of the prosthesis.

15. The tubular prosthesis of claim 12, wherein at least one of the apertures form an elongate slot.

16. The tubular prosthesis of claim 1, wherein the bridge member has a thickness in a radial direction, the thickness varying across the bridge member.

17. The tubular prosthesis of claim 1, wherein the bridge member, from the first end to the second end, defines a step shape and further includes a strain relief region, the strain relief region comprising an area with a reduced width where the bridge member transitions from being parallel to the longitudinal axis to being perpendicular to the longitudinal axis.

18. The tubular prosthesis of claim 1, wherein the bridge member has a first radial thickness and the plurality of axially oriented struts have a second radial thickness different than the first thickness.

19. The tubular prosthesis of claim 18, wherein the first radial thickness is less than the second radial thickness.

20. The tubular prosthesis of claim 1, wherein the bridge member comprises a resilient elastomer.

21. The tubular prosthesis of claim 1, wherein adjacent struts of each of the tubular rings of the plurality are connected by a connector, and the bridge member is slidably engaged with the connector.

22. The tubular prosthesis of claim 1, wherein the bridge member comprises a first axially oriented portion such that the transverse portion extends transverse to the first axially oriented portion and is coupled thereto.

23. The tubular prosthesis of claim 22, wherein the bridge member further comprises a second axially oriented portion, the transverse portion disposed between the first and second axially oriented portions.

24. The tubular prosthesis of claim 1, wherein the bridge member has an axial length between the first and second ends longer than the axial distance between high peaks on adjacent tubular rings.

25. The tubular prosthesis of claim 1, wherein the bridge member has an axial length between the first and second ends longer than the axial distance between a high peak and a low peak on adjacent tubular rings.

26. The tubular prosthesis of claim 1, wherein the first tubular ring is disposed between the second tubular ring and a third tubular ring, the first tubular ring being connected to the third tubular ring by a second bridge member.

27. The tubular prosthesis of claim 26, wherein the bridge member has a first orientation and the second bridge member has a second orientation, wherein the second orientation is a mirror image of the first orientation.

28. The tubular prosthesis of claim 26, wherein the bridge member has a first slope and the second bridge member has a second slope, the second slope being opposite the first slope.

29. The tubular prosthesis of claim 1, wherein the first end of the bridge member connects to the first low peak at the apex thereof.

30. The tubular prosthesis of claim 1, wherein the second end of the bridge member connects to the apex of the low peak in the adjacent tubular ring.

31. The tubular prosthesis of claim 1, further comprising a therapeutic agent carried by the prosthesis and adapted to being released therefrom at a controlled rate.

32. The tubular prosthesis of claim 1, wherein the plurality of tubular rings are self-expanding.

33. The tubular prosthesis of claim 1, wherein the tubular prosthesis has a length in the range from about 2 mm to about 200 mm.

34. The tubular prosthesis of claim 1, wherein each of the plurality of tubular rings has the same axial length.

35. The tubular prosthesis of claim 1, further comprising a third tubular ring adjacent the first tubular ring and unconnected thereto.

36. The tubular prosthesis of claim 35, further comprising a fourth tubular ring unconnected to but deployable with the first or third tubular ring.

37. The tubular prosthesis of claim 1, wherein the entire transverse portion is oriented perpendicular to the longitudinal axis of the tubular prosthesis, the transverse portion being disposed between a first peak on the first tubular ring and a second peak on the second tubular ring thereby preventing the first peak from overlapping with the second peak when the tubular prosthesis is in compression.

38. The tubular prosthesis of claim 1, wherein the bridge member comprises an axial portion and a circumferential portion transverse thereto.

39. The tubular prosthesis of claim 1, wherein the bridge member has a width equivalent to a width of the axial struts.

40. The tubular prosthesis of claim 1, wherein the bridge member comprises a first axially oriented region which includes the first end, and a second axially oriented region which includes the second end.

41. The tubular prosthesis of claim 1, wherein the plurality of struts are parallel when in the contracted configuration.

42. The tubular prosthesis of claim 1, wherein the bridge member comprises two axially oriented sections coupled together with a transverse section forming a step shape.

43. A tubular prosthesis comprising:

a plurality of tubular rings radially expandable from a contracted configuration to an expanded configuration, each ring comprising a plurality of axially oriented struts interconnected so as to form a plurality of high peaks and a plurality of low peaks, the plurality of high peaks and the plurality of low peaks being circumferentially arranged to form an alternating series of high peaks and low peaks, the high and low peaks having apices oriented in the same axial direction, the apices of the high peaks being axially offset from the apices of the low peaks, the apices of the high peaks being substantially axially aligned with one another, the apices of the low peaks being substantially axially aligned with one another,

wherein each strut of the plurality has a width and is connected to a circumferentially adjacent strut of the plurality of struts at a common longitudinal end by a U-shaped connector,

wherein each pair of adjacent tubular rings of the plurality of tubular rings are circumferentially offset from one another such that a high peak on a first tubular ring of a respective pair of adjacent tubular rings is disposed circumferentially between two high peaks on a second tubular ring of the respective pair of adjacent tubular rings along a longitudinal axis of the prosthesis; and

a plurality of bridge members coupling each pair of adjacent tubular rings together, each and every bridge member having a first end connected to a low peak of the first tubular ring and a second end connected to a low peak of the adjacent tubular ring,

wherein the first end of the bridge member is circumferentially offset from the second end of the bridge member,

wherein each bridge member has a non-linear intermediate portion extending between the first and second ends, wherein the non-linear intermediate portion includes a transverse portion extending in a direction perpendicular to the longitudinal axis of the tubular prosthesis when the prosthesis is in the contracted configuration,

wherein each and every bridge member of the prosthesis extends circumferentially between adjacent unconnected high peaks of first and second adjacent tubular rings of the respective adjacent pair of tubular rings connected by the respective bridge member and extends a length greater than a circumferential distance between the respective adjacent unconnected high peaks of the respective pair of adjacent tubular rings such that the respective bridge member inhibits contact between and overlapping of the unconnected adjacent high peaks of the respective adjacent tubular rings during flexure of the tubular prosthesis in the contracted configuration,

wherein the non-linear bridge member includes a portion, between the first end and the second end, having a reduced thickness by curving inward on only one side to facilitate flexibility between the first and second tubular rings coupled with the non-linear bridge member.

44. The tubular prosthesis of claim 43, wherein each high and low peak is separated from an adjacent high or low peak by a valley, and wherein the circumferential width of each valley in the contracted configuration is less than the circumferential width of each peak in the contracted configuration.

45. The tubular prosthesis of claim 43, wherein the high and low peaks circumferentially alternate with one another in the first tubular ring.

46. The tubular prosthesis of claim 43, wherein the apices of the high and low peaks in the first tubular ring are circumferentially offset from the apices of the high and low peaks in the adjacent tubular ring.

47. The tubular prosthesis of claim 43, wherein each high peak comprises a long strut having a first length and each low peak comprises a short strut having a second length shorter than the first length.

48. The tubular prosthesis of claim 43, wherein the plurality of axially oriented struts comprise long struts and short struts, the short struts shorter than the long struts and wherein the plurality of axially oriented struts are arranged circumferentially such that each short strut is disposed between one long strut and one short strut.

49. The tubular prosthesis of claim 48, wherein the long struts have a first width and the short struts have a second width less than the first width.

50. The tubular prosthesis of claim 43, wherein the low and the high peaks are arranged circumferentially such that each high peak is disposed between two low peaks.

51. The tubular prosthesis of claim 43, wherein the apices of the high and low peaks of the first tubular ring point toward the apices of the high and low peaks of the adjacent tubular ring.

52. The tubular prosthesis of claim 43, wherein each high and low peak is separated from an adjacent high or low peak by a valley, and wherein the high peaks on the first tubular ring are nested between valleys on the adjacent tubular ring.

53. The tubular prosthesis of claim 43, wherein the apices of the low peaks in the first tubular ring are circumferentially aligned with the apices of the high peaks in the adjacent tubular ring.

54. The tubular prosthesis of claim 43, wherein the first tubular ring is disposed between the adjacent tubular ring and a third tubular ring, the first tubular ring being connected to the third tubular ring with a second bridge member.

55. The tubular prosthesis of claim 54, wherein the bridge member has a first orientation and the second bridge member has a second orientation, wherein the second orientation is a mirror image of the first orientation.

56. The tubular prosthesis of claim 43, wherein the first end of the bridge member connects to a portion of a first peak offset from the apex thereof in the first tubular ring.

57. The tubular prosthesis of claim 43, wherein the second end of the bridge member connects to a portion of a peak offset from the apex thereof in the adjacent tubular ring.

58. The tubular prosthesis of claim 43, further comprising a therapeutic agent carried by the prosthesis and adapted to being released therefrom at a controlled rate.

59. The tubular prosthesis of claim 43, wherein the plurality of tubular rings are self-expanding.

60. The tubular prosthesis of claim 43, wherein the tubular prosthesis has a length in the range from about 2 mm to about 200 mm.

61. The tubular prosthesis of claim 43, wherein each of the plurality of tubular rings has the same axial length.

62. The tubular prosthesis of claim 43, further comprising a third tubular ring adjacent the first tubular ring and unconnected thereto.

63. The tubular prosthesis of claim 62, further comprising a fourth tubular ring unconnected to but deployable with the first or third tubular ring.

64. The tubular prosthesis of claim 43, wherein each of the high peaks has the same shape and dimension as an adjacent high peak on each ring.