Stent graft with longitudinal support member

• US 8,292,943 B2
• Filed: 02/23/2004
• Issued: 10/23/2012
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Berra, Humberto A., Arbefeuille, Samuel
• Primary Examiner(s): Pellegrino, Brian E.
• Application Number:
  US10/784,462
• Publication Number:
  US 20050049674A1
• Time in Patent Office: 3,165 Days
• Field of Search: 623/1.13, 623/1.16, 623/1.23, 623/1.29, 623/1.32, 623/1.1, 623/1.15, 623/1.17, 623/1.2
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: Y10T 29/49799 Providing transitory integral holding or handling portion
• CPC Class Codes: Y10T 74/18392 Crank, pitman, and crank

Abstract

A vascular repair device includes a tubular graft body and a structural framework having at least two stents connected to the graft body. Stents of the structural framework can each be respectively connected to graft body adjacent the proximal and ends and the support member is shorter than the separation distance therebetween to form a gimbal at least at one end. A first stent is connected along an entirety thereof and a second stent is connected at distal apices thereof. Distal apices of the second stent have radii of curvature smaller than proximal apices. A curved longitudinal support member can be connected to the graft body, the support member being substantially symmetrical with respect to the centerline. The support member can be connected to the graft body independent of the structural framework. At least one of the ends of the support member can have a curved longitudinal extremity.

Claims

1. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis and a circumference;

a structural framework having at least two Z-stents connected circumferentially to said graft body;

a curved, metallic, longitudinal support member, that is on one side of a plane parallel to and bisecting said longitudinal axis of said graft body;

having substantially asymptotic ends,

connected to said graft body,

having a length,

having a centerline at said graft body parallel to said longitudinal axis, and

when viewed in an orientation where said longitudinal axis and said centerline are aligned with one another, said support member being substantially reverse-mirror symmetrical with respect to said longitudinal axis and said length; and

on a second side of the plane the graft body being free of the longitudinal support member.

2. The vascular repair device, according to claim 1, wherein said longitudinal support member is of a material selected from the group consisting of nitinol, stainless steel, Cobalt Chrome, and titanium alloys.

3. The vascular repair device according to claim 1, wherein said longitudinal support member has a partial helix shape.

4. The vascular repair device according to claim 1, wherein said longitudinal support member is connected to said graft body independent of said structural framework.

5. The vascular repair device according to claim 1, wherein said longitudinal support member is pre-formed in said curved shape.

6. The vascular repair device according to claim 1, wherein said longitudinal support member has rounded ends.

7. The vascular repair device according to claim 1, wherein said longitudinal support member has a looped end with a curved longitudinal extremity.

8. The vascular repair device according to claim 1, wherein said longitudinal support member has two looped ends each with curved longitudinal extremities.

9. The vascular repair device according to claim 1, wherein said longitudinal support member is shorter than said structural framework.

10. The vascular repair device according to claim 1, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

11. The vascular repair device according to claim 1, wherein:

said at least two stents each have apices;

said structural framework has a distal-most stent; and

said distal-most stent has at least one more apex than another of said at least two stents.

12. The vascular repair device according to claim 1, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

13. The vascular repair device according to claim 12, wherein said stents have a linear longitudinal profile.

14. The vascular repair device according to claim 12, wherein said stents have a circular cross-sectional shape.

15. The vascular repair device of claim 1, wherein a proximal portion of the curved longitudinal support member is relatively parallel to an axis of the tubular graft body at a first degree, and a distal portion of the curved longitudinal support member is relatively parallel to the axis of the tubular graft body at a second degree, the second degree being different than the first degree.

16. The vascular repair device of claim 15, wherein the proximal and distal ends of the curved longitudinal support extend asymptotically to the first and second degree, respectively.

17. The vascular repair device of claim 16, wherein the tubular graft body is about 20 cm long, and wherein the first and second degrees are separated by an angle in a range of between 80 and 110 degrees.

18. The vascular repair device of claim 16, wherein the tubular graft body is about 9 cm long, and wherein the first and second degrees are separated by an angle in a range of between 30 and 60 degrees.

19. The vascular repair device of claim 18, wherein the first and second degrees are separated by an angle of about 45 degrees.

20. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis;

a structural framework having at least two Z-stents connected circumferentially to said tubular graft body; and

a curved longitudinal support member on one side of a plane parallel to and bisecting a longitudinal axis of said graft body, the longitudinal support member being substantially reverse-mirror symmetrical with respect to said longitudinal axis and having substantially asymptotic ends, and being connected to said graft body independent of said structural framework and having two ends, at least one of said ends having a longitudinal extremity curved back upon itself, and on the other side of the plane the graft body being free of the longitudinal support member.

21. The vascular repair device according to claim 20, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

22. The vascular repair device according to claim 20, wherein:

said at least two stents each have apices;

said structural framework has a distal-most stent; and

said distal-most stent has at least one more apex than another of said at least two stents.

23. The vascular repair device according to claim 20, wherein said stents have a linear longitudinal profile.

24. The vascular repair device according to claim 20, wherein said stents have a circular cross-sectional shape.

25. The vascular repair device according to claim 20, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

26. The vascular repair device according to claim 25, wherein said stents have a linear longitudinal profile.

27. The vascular repair device according to claim 25, wherein said stents have a circular cross-sectional shape.

28. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis and having a proximal end and a distal end;

a structural framework having at least two stents each respectively connected to said tubular graft body adjacent said proximal end and said distal end and defining a separation distance there between; and

a curved longitudinal support member having substantially asymptotic ends, being shorter than said separation distance and being connected to said graft body on one side of a plane parallel to and bisecting a longitudinal axis of said graft body, the longitudinal support member being substantially reverse-mirror symmetrical with respect to said longitudinal axis and between said at least two stents to form a gimbal at at least one of said proximal and distal ends of said graft body, and, on the other side of the plane the graft body being free of the longitudinal support member.

29. The vascular repair device according to claim 28, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

30. The vascular repair device according to claim 28, wherein:

said at least two stents each have apices;

said structural framework has a distal-most stent; and

said distal-most stent has at least one more apex than another of said at least two stents.

31. The vascular repair device according to claim 28, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

32. The vascular repair device according to claim 31, wherein said stents have a linear longitudinal profile.

33. The vascular repair device according to claim 31, wherein said stents have a circular cross-sectional shape.

34. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis and having a proximal end and a distal end;

a structural framework having at least first and second pairs of Z-stents each respectively connected to said graft body adjacent said proximal end and said distal end, said stents of each of said first and second pairs of stents being separated from one another at said graft body to define a respective outer stent and a respective inner stent; and

a curved longitudinal, metallic support member having substantially asymptotic ends being substantially reverse-mirror symmetrical with respect to said longitudinal axis and on one side of a plane parallel to and bisecting a longitudinal axis of said graft body and connected to said graft body and an entirety thereof extending between,

said inner stent of said first pair of stents, and

said outer stent of said second pair of stents, and, on the other side of the plane the graft body being free of the longitudinal support member.

35. The vascular repair device according to claim 34, wherein said support member is connected to said graft body and said entirety thereof extends between both of said inner stents of said pairs of stents.

36. The vascular repair device according to claim 34, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

37. The vascular repair device according to claim 34, wherein:

said stents each have apices;

one of said pairs of stents adjacent said distal end has a distal-most stent; and

said distal-most stent has at least one more apex than another of said stents.

38. The vascular repair device according to claim 34, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

39. The vascular repair device according to claim 38, wherein said stents have a linear longitudinal profile.

40. The vascular repair device according to claim 38, wherein said stents have a circular cross-sectional shape.

41. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis, a circumference, a proximal end and a distal end;

a structural framework having at least two pairs of stents each respectively connected to said graft body adjacent said proximal end and said distal end, said stents of each of said pairs of stents being separated from one another at said graft body to define a respective outer stent and a respective inner stent;

a curved longitudinal support member having substantially asymptotic ends and on one side of a plane parallel to and bisecting a longitudinal axis of said graft body, the curved longitudinal support being substantially reverse-mirror symmetrical with respect to said longitudinal axis and,

having two ends,

having a portion between said two ends curved partially around said circumference of said tubular graft body, and

being connected to said graft body between both of said inner stents of said two pairs of stents such that longitudinal contraction of the graft body is substantially prevented where the support member is connected to the graft body, and, on the other side of the plane the graft body being free of the longitudinal support member.

42. The vascular repair device according to claim 41, wherein said support member is connected to said graft body without touching said inner stents.

43. The vascular repair device according to claim 41, wherein said support member is connected to said graft body to touch at least one of said inner stents.

44. The vascular repair device according to claim 41, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

45. The vascular repair device according to claim 41, wherein:

said stents each have apices;

one of said pairs of stents adjacent said distal end has a distal-most stent; and

said distal-most stent has at least one more apex than another of said stents.

46. The vascular repair device according to claim 41, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

47. The vascular repair device according to claim 46, wherein said stents have a linear longitudinal profile.

48. The vascular repair device according to claim 46, wherein said stents have a circular cross-sectional shape.

49. A vascular repair device, comprising:

a tubular graft body having a longitudinal axis and first and second ends;

a structural framework having at least three stents, two of said stents being connected to said tubular graft body adjacent said first end, said two stents being separated from one another on said graft body to define an outer stent and an inner stent, a third of said stents being connected to said tubular graft body adjacent said second end; and

a curved longitudinal support member having substantially asymptotic ends and on one side of a plane parallel to and bisecting a longitudinal axis of said graft body, the longitudinal support member having two ends and being substantially reverse-mirror symmetrical with respect to said longitudinal axis and connected to said graft body between said inner stent and said third stent without touching said inner stent and said third stent such that longitudinal contraction of the graft body is substantially prevented where the support member is connected to the graft body, and, on the other side of the plane the graft body being free of the longitudinal support member.

50. The vascular repair device according to claim 49, wherein said graft body has a diameter at least as large as a diameter of a vessel into which said graft body is to be placed.

51. The vascular repair device according to claim 49, wherein:

said stents each have apices;

one of said stents is a distal-most stent; and

said distal-most stent has at least one more apex than another of said stents.

52. The vascular repair device according to claim 49, wherein:

said graft body has a longitudinal extent defining a longitudinal direction; and

said stents have a substantially linear profile in said longitudinal direction.

53. The vascular repair device according to claim 52, wherein said stents have a linear longitudinal profile.

54. The vascular repair device according to claim 52, wherein said stents have a circular cross-sectional shape.