Stent and stent graft prosthesis

• US 9,993,329 B2
• Filed: 06/01/2012
• Issued: 06/12/2018
• Est. Priority Date: 06/03/2011
• Status: Active Grant

• Current Assignee: Vascutek Limited (Terumo Corporation)
• Original Assignee: Vascutek Limited (Terumo Corporation)
• Inventors: McDonald, Gary Peter, Nelis, Vincent
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US14/123,667
• Publication Number:
  US 20140121761A1
• Time in Patent Office: 2,202 Days
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A stent graft prosthesis includes spaced stent elements for location on a tubular graft. First and second stent elements are located in first and second locations on the graft. The second stent element includes a saddle shaped stent. The first stent element includes a ring shaped stent. Optionally a third stent element is also present. The tubular graft includes a graft sleeve. The prosthesis can be used for treatment of vascular disorders such as aortic aneurysm.

Claims

1. An implantable prosthesis comprising:

i) a compliant and substantially fluid impervious tubular sleeve having a proximal end and a distal end with a conduit therethrough;

ii) a first stent element comprising at least one stent formed from multiple windings of wire fabricated from shape memory material, attached to said sleeve at a first location thereon;

iii) a second stent element attached to said sleeve comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally; and

iv) a third stent element attached to said sleeve configured to extend through an outwardly dilated portion of a vessel to treat the dilated portion when the prosthesis is positioned within the vessel comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally and wherein the spacing of each stent of the third stent element is such that the peak of one stent is transversely aligned with the valley of each immediately neighboring stent of the third stent element,

wherein each peak of each separate stent of the second stent element is longitudinally aligned with a peak of each separate stent of the third stent element,

wherein the axial displacement between the peaks and valleys of each separate stent of the third stent element is larger than the axial displacement between the peaks and valleys of each separate stent of the second stent element,

wherein the ring stents of each of the first stent element, the second stent element and the third stent element are not directly coupled to each other, and

wherein at least one stent of at least one of the first stent element, the second stent element or the third stent element is positioned externally of the tubular graft.

2. The prosthesis as claimed in claim 1, wherein at least one stent of at least one of the first stent element, the second stent element or the third stent element is positioned internally of the tubular graft.

3. The prosthesis as claimed in claim 1, wherein the axial displacement between the peaks and valleys of each separate stent of the third stent element is greater than or equal to the spacing from that stent of the third stent element to each immediately neighboring stent.

4. A method of treating an aneurysm of the aortic arch, said method comprising inserting a prosthesis as claimed in claim 1 such that the first stent element sealingly engages with the inner luminal wall of the aorta, the second stent element provides the flexibility able to accommodate the angulation associated with the descending thoracic arch, and the third stent element provides axial and torsional stiffness required to ensure the integrity of the graft within the aneurysm sac and/or within the longer straighter section of the descending aorta.

5. An implantable prosthesis comprising:

i) a compliant and substantially fluid impervious tubular sleeve having a proximal end and a distal end with a conduit therethrough;

ii) a first stent element comprising at least one stent formed from multiple windings of wire fabricated from shape memory material, attached to said sleeve at a first location thereon;

iii) a second stent element attached to said sleeve comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally; and

iv) a third stent element attached to said sleeve comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally,

wherein each peak of each separate stent of the second stent element is longitudinally aligned with a peak of each separate stent of the third stent element,

wherein the axial displacement between the peaks and valleys of each separate stent of the third stent element is larger than the axial displacement between the peaks and valleys of each separate stent of the second stent element,

wherein the ring stents of each of the first stent element, the second stent element and the third stent element are not directly coupled to each other,

wherein the saddle height of a stent of the third stent element is greater than or equal to the spacing from that stent of the third stent element to each immediately neighboring stent.

6. The prosthesis as claimed in claim 5, wherein the saddle height of a stent of the third stent element is from 10-25 mm.

7. The prosthesis as claimed in claim 5, wherein the saddle height of a stent of the third stent element is from 13-22 mm.

8. The prosthesis as claimed in claim 5, wherein the saddle height of each stent of the third stent element increases successively from one stent of the third stent element to the next with distance away from the second stent element.

9. The prosthesis as claimed in claim 5, wherein a distance D between two neighboring stents of the third stent element is from 0.5 cm to 5 cm.

10. The prosthesis as claimed in claim 5, wherein the third stent element comprises at least four independent ring stents each having an oversize of 20 to 30%.

11. The prosthesis as claimed in claim 10, wherein said third stent element comprises 5 to 10 independent ring stents each having an oversize of 20 to 30%.

12. The prosthesis as claimed in claim 10, wherein each independent stent of the third stent element has a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, and wherein each independent stent of the third stent element is attached to the graft so that the peaks and valleys are longitudinally aligned with the peaks and valleys of the other independent stents of the third stent element.

13. The prosthesis as claimed in claim 5, wherein the spacing of each stent of the third stent element is such that the peak of one stent is transversely aligned with the valley of each immediately neighboring stent of the third stent element.

14. The prosthesis as claimed in claim 13, wherein the third stent element is configured to be positioned at an outwardly dilated portion of a vessel when the prosthesis is implanted within the vessel to treat the dilated portion.

15. The prosthesis as claimed in claim 5, comprising a fourth stent element which comprises an independent circular ring stent, wherein said fourth stent element further comprises an independent saddle shaped ring stent located adjacent the independent circular ring stent and at a distance ranging from touching the independent circular ring stent to about 2 mm.

16. The prosthesis as claimed in claim 5, wherein the first stent element comprises at least one independent ring stent having an inner circumference substantially identical to the outer circumference of the sleeve, wherein the second stent element comprises at least two independent saddle shaped stents each having a saddle height, wherein the saddle height is at least 5 mm, and wherein the third stent element comprises at least two independent saddle shaped stents each having a saddle height, wherein the saddle height is at least 10 mm, and

wherein the independent stents of the first, second and third stent elements are not directly coupled to each other.

17. A method of treating an aneurysm of the aortic arch, said method comprising inserting a prosthesis as claimed in claim 5 such that the first stent element sealingly engages with the inner luminal wall of the aorta, the second stent element provides the flexibility able to accommodate the angulation associated with the descending thoracic arch, and the third stent element provides axial and torsional stiffness required to ensure the integrity of the graft within the aneurysm sac and/or within the longer straighter section of the descending aorta.

18. An implantable prosthesis comprising:

i) a compliant and substantially fluid impervious tubular sleeve having a proximal end and a distal end with a conduit therethrough;

ii) a first stent element comprising at least one stent formed from multiple windings of wire fabricated from shape memory material, attached to said sleeve at a first location thereon;

iii) a second stent element attached to said sleeve comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally;

iv) a third stent element attached to said sleeve comprising at least two separate stents, each formed from multiple windings of wire fabricated from shape memory material, each separate stent having a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, the valleys being axially displaced relative to the peaks, wherein the peaks of each separate stent are aligned longitudinally; and

(v) a fourth stent element which comprises an independent saddle shaped ring stent located adjacent a terminal independent circular ring stent and at a distance ranging from touching the independent circular ring stent to about 2 mm,

wherein each peak of each separate stent of the second stent element is longitudinally aligned with a peak of each separate stent of the third stent element,

wherein the axial displacement between the peaks and valleys of each separate stent of the third stent element is larger than the axial displacement between the peaks and valleys of each separate stent of the second stent element,

wherein the ring stents of each of the first stent element, the second stent element and the third stent element are not directly coupled to each other,

wherein the saddle height of a stent of the third stent element is greater than or equal to the spacing from that stent of the third stent element to each immediately neighboring stent.

19. The prosthesis as claimed in claim 18, wherein the saddle height of a stent of the third stent element is from 10-25 mm.

20. The prosthesis as claimed in claim 18, wherein the saddle height of a stent of the third stent element is from 13-22 mm.

21. The prosthesis as claimed in claim 18, wherein the saddle height of each stent of the third stent element increases successively from one stent of the third stent element to the next with distance away from the second stent element.

22. The prosthesis as claimed in claim 18, wherein the spacing of each stent of the third stent element is such that the peak of one stent is transversely aligned with the valley of each immediately neighboring of the third stent element.

23. The prosthesis as claimed in claim 22, wherein the first and second stent elements are configured to sealingly engage with an inner luminal wall of a vessel, the second stent element is configured to extend within an angulating portion of the vessel, and the third stent is configured to extend within a portion of the vessel wherein the inner luminal wall is outwardly dilated, when then the prosthesis is positioned within the vessel to treat the dilated portion.

24. The prosthesis as claimed in claim 18, wherein the third stent element comprises at least four independent ring stents each having an oversize of 20 to 30%.

25. The prosthesis as claimed in claim 24, wherein said third stent element comprises 5 to 10 independent ring stents each having an oversize of 20 to 30%.

26. The prosthesis as claimed in claim 24, wherein each independent stent of the third stent element has a saddle shape configuration with two diametrically opposed peaks and two diametrically opposed valleys, and wherein each independent stent of the third stent element is attached to the graft so that the peaks and valleys are longitudinally aligned with the peaks and valleys of the other independent stents of the third stent element.

27. The prosthesis as claimed in claim 18, wherein the first stent element comprises at least one independent ring stent having an inner circumference substantially identical to the outer circumference of the sleeve, wherein the second stent element comprises at least two independent saddle shaped stents each having a saddle height, wherein the saddle height is at least 5 mm, and wherein the third stent element comprises at least two independent saddle shaped stents each having a saddle height, wherein the saddle height is at least 10 mm, and

wherein the independent stents of the first, second and third stent elements are not directly coupled to each other.

28. A method of treating an aneurysm of the aortic arch, said method comprising inserting a prosthesis as claimed in claim 18 such that the first stent element sealingly engages with the inner luminal wall of the aorta, the second stent element provides the flexibility able to accommodate the angulation associated with the descending thoracic arch, and the third stent element provides axial and torsional stiffness required to ensure the integrity of the graft within the aneurysm sac and/or within the longer straighter section of the descending aorta.