Intravascular implants and methods of using the same

• US 9,744,026 B2
• Filed: 10/03/2016
• Issued: 08/29/2017
• Est. Priority Date: 02/12/2003
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Thomas J. Fogarty
• Inventors: Fogarty, Thomas J., Drews, Michael J., Holmgren, Neil D., Modesitt, D. Bruce
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US15/284,381
• Publication Number:
  US 20170020654A1
• Time in Patent Office: 330 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2250/0069 Sealing means

Abstract

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff.

Claims

1. A device for treating an aneurysm having a longitudinal axis, the device comprising:

a vascular graft comprising a tubular channel having a first end and a second end, wherein the tubular channel is bifurcated at a bifurcated portion at the second end;

an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to a circumference of the vascular graft, wherein the expandable anchor comprises a first anchor portion having a first transverse diameter and a second anchor portion having a second transverse diameter, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse diameter is greater than the first transverse diameter, and wherein the second anchor portion is a terminal end of the expandable anchor; and

a seal on the vascular graft, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and comprises a seal volume fillable by a fluid,

wherein the seal comprises a first seal portion and a second seal portion,

wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,

wherein the first seal portion has a first portion radius measured from the longitudinal axis of the device to a furthest point on an exterior surface of the first seal portion,

wherein the second seal portion has a second portion radius measured from the longitudinal axis of the device to the furthest point on an exterior surface of the second seal portion,

wherein the first length of material has a first length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the first length of material,

wherein the second length of material has a second length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the second length of material,

wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and

wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

2. The device of claim 1, wherein the first seal portion and the second seal portion are in fluid communication.

3. The device of claim 1, wherein the vascular graft is connected to the expandable anchor by connectors and wherein at least two of the connectors are joined in an x-shaped pattern.

4. The device of claim 1, wherein the seal comprises at least one of polytetrafluoroethylene (PTFE), polyester, polyurethane, nylon, and silicone.

5. The device of claim 1, wherein the seal is configured to assist in holding the vascular graft in place within a blood vessel of a patient.

6. The device of claim 1, wherein the fluid is a biocompatible fluid.

7. The device of claim 1, wherein the vascular graft is configured to be placed across an abdominal aortic aneurysm.

8. The device of claim 1, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the circumference of the vascular graft.

9. The device of claim 1, wherein the seal has a gap in a circumference of the seal.

10. The device of claim 1, wherein the seal forms a c-ring.

11. The device of claim 1, wherein the terminal end of the second anchor portion is configured to contact tissue.

12. The device of claim 1, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.

13. A device for treating an aneurysm having a longitudinal axis, the device comprising:

a vascular graft comprising a tubular channel having a first end and a second end;

an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to the longitudinal axis, wherein the expandable anchor comprises a first anchor portion having a first transverse diameter and a second anchor portion having a second transverse diameter, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse diameter is greater than the first transverse diameter, and wherein the second anchor portion is a terminal end of the expandable anchor; and

a seal on the vascular graft, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and comprises a seal volume fillable by a fluid,

wherein the seal comprises a first seal portion and a second seal portion,

wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,

wherein the first seal portion has a first portion radius measured from the longitudinal axis of the device to a furthest point on an exterior surface of the first seal portion,

wherein the second seal portion has a second portion radius measured from the longitudinal axis of the device to the furthest point on an exterior surface of the second seal portion,

wherein the first length of material has a first length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the first length of material,

wherein the second length of material has a second length of material radius measured from the longitudinal axis of the device to the furthest point along an exterior surface of the second length of material,

wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and

wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

14. The device of claim 13, wherein the seal comprises at least one of polytetrafluoroethylene (PTFE), polyester, polyurethane, nylon, and silicone.

15. The device of claim 13, wherein the seal is configured to assist in holding the vascular graft in place within a blood vessel of a patient.

16. The device of claim 13, wherein the fluid is a biocompatible fluid.

17. The device of claim 13, wherein the vascular graft is configured to be placed across an abdominal aortic aneurysm.

18. The device of claim 13, further comprising at least two connectors connecting the expandable anchor to the vascular graft, wherein the two connectors are joined in an x-shaped pattern.

19. The device of claim 13, further comprising a seal cover covering the seal.

20. The device of claim 13, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the longitudinal axis.

21. The device of claim 13, wherein the seal has a gap in a circumference of the seal.

22. The device of claim 13, wherein the seal forms a c-ring.

23. The device of claim 13, wherein the terminal end of the second anchor portion is configured to contact tissue.

24. The device of claim 13, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.

25. A method of treating an aneurysm, the method comprising:

positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel of a patient, wherein the tubular channel is bifurcated at a bifurcated portion at the second end;

securing the vascular graft in place with an expandable anchor attached to the first end of the tubular channel, wherein the expandable anchor comprises anchor arms, wherein each of the anchor arms extends at least partially in a longitudinal direction, wherein each of the anchor arms extends radially outward relative to the longitudinal axis, and wherein a leaf portion partially covers at least two of the longitudinal anchor arms;

expanding the expandable anchor, wherein the expandable anchor comprises a first anchor portion having a first transverse width and a second anchor portion having a second transverse width, wherein the first and second anchor portions are defined by the anchor arms, wherein the second anchor portion is more distal to the vascular graft than the first anchor portion, wherein the second transverse width is greater than the first transverse width when the expandable anchor is expanded, and wherein the second anchor portion is a terminal end of the expandable anchor; and

filling a seal on the vascular graft with a fluid, wherein the seal extends radially outward beyond an exterior surface of the vascular graft and the fluid fills a seal volume,

wherein the seal comprises a first seal portion and a second seal portion,

wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,

wherein the first seal portion has a first portion radius measured from the longitudinal axis to a furthest point on an exterior surface of the first seal portion,

wherein the second seal portion has a second portion radius measured from the longitudinal axis to the furthest point on an exterior surface of the second seal portion,

wherein the first length of material has a first length of material radius measured from the longitudinal axis to the furthest point along an exterior surface of the first length of material,

wherein the second length of material has a second length of material radius measured from the longitudinal axis to the furthest point along an exterior surface of the second length of material,

wherein the first portion radius is greater than the first length of material radius and the second length of material radius, and

wherein the second portion radius is greater than the first length of material radius and the second length of material radius.

26. The method of claim 25, further comprising positioning the vascular graft across an abdominal aortic aneurysm.

27. The method of claim 25, wherein the vascular graft is connected to the expandable anchor by connectors and wherein at least two of the connectors are joined in an x-shaped pattern.

28. The device of claim 25, wherein only a portion of each of the anchor arms extends longitudinally, and wherein only a portion of each of the anchor arms extends radially outward relative to the longitudinal axis.

29. The device of claim 25, wherein the seal has a gap in a circumference of the seal.

30. The device of claim 25, wherein the seal forms a c-ring.

31. The device of claim 25, wherein the terminal end of the second anchor portion is configured to contact tissue.

32. The device of claim 25, wherein the expandable anchor is configured to allow fluid to flow through the vascular graft when the expandable anchor is in an expanded configuration.