Advanced endovascular graft

• US 7,147,660 B2
• Filed: 12/20/2002
• Issued: 12/12/2006
• Est. Priority Date: 12/20/2001
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Boston Scientific Scimed Incorporated
• Inventors: Zacharias, Isaac J., Marthaler, John M., Chobotov, Michael V., Whirley, Robert G., Glynn, Brian A., Stephens, W. Patrick, Kari, Stuart E.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US10/327,711
• Publication Number:
  US 20030125797A1
• Time in Patent Office: 1,453 Days
• Field of Search: 623/1.13, 623/1.14, 623/1.25, 623/23.67, 623/1.35, 623/1.36
• US Class Current: 623/1.14
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Claims

1. An endovascular graft comprising:

a graft body section having a proximal end and a distal end;

a proximal connector member affixed to the proximal end of the graft body section, the proximal connector member comprising one or more proximal, cantilevered connector member connector elements;

a proximal stent comprising one or more proximal, cantilevered stent connector elements affixed to the one or more proximal connector member connector elements to space the proximal stent proximal to the proximal end of the graft body; and

one or more coupling members, wherein;

the one or more proximal connector member connector elements comprise a proximal end and a distal end and shoulder portions at the proximal and distal ends;

the one or more proximal stent connector elements comprise a proximal end and a distal end and shoulder portions at the proximal and distal ends; and

the one or more coupling members couple the one or more proximal connector member connector elements to the one or more proximal stent connector elements.

2. The endovascular graft of claim 1 wherein the proximal connector member is embedded within the graft body section.

3. The endovascular graft of claim 1 wherein the coupling member is a wire coil.

4. The endovascular device of claim 1 wherein the proximal connector member comprises a serpentine ring comprising apices.

5. The endovascular device of claim 1 wherein the proximal stent comprises a serpentine ring comprising apices.

6. The endovascular device of claim 1 wherein:

the proximal connector member comprises a serpentine ring comprising apices, wherein the number of proximal connector member apices is n; and

the proximal stent comprises a serpentine ring comprising apices, wherein the number of proximal stent apices is n.

8. The endovascular graft of claim 1 further comprising a distal connector member affixed to the distal end of the graft body section and a distal stent affixed to the distal connector member.

9. The endovascular graft of claim 1 wherein the proximal stent further comprises one or more integrally formed barbs.

10. The endovascular graft of claim 8 wherein the distal stent further comprises one or more integrally formed barbs.

11. The endovascular graft of claim 10 wherein the one or more integrally formed barbs are oriented proximally.

12. The endovascular graft of claim 9 wherein the one or more barbs are oriented distally.

13. The endovascular graft of claim 10 wherein the proximal stent further comprises one or more barbs and wherein the one or more proximal stent barbs are oriented distally and wherein the one or more distal stent barbs are oriented proximally.

14. The endovascular graft of claim 13 wherein the one or more proximal stent barbs or the one or more distal stent barbs have a length from about 2 mm to about 4 mm.

15. The endovascular graft of claim 1 wherein an inflatable cuff is disposed at the proximal end of the graft body section.

16. The endovascular graft of claim 15 wherein an inflatable cuff is disposed at the distal end of the graft body section.

17. The endovascular graft of claim 1 wherein the graft body section comprises an inflatable channel.

18. The endovascular graft of claim 17 wherein the inflatable channel is disposed in a helical configuration along the graft body section.

19. The endovascular graft of claim 18 wherein the inflatable channel comprises a plurality of circumferential rings and a spine that is in fluid communication with the plurality of circumferential rings.

20. The endovascular graft of claim 15 wherein the graft body section comprises an inflatable channel.

21. The endovascular graft of claim 15 wherein at least one of the inflatable cuff and the inflatable channel contains an inflation medium.

22. The endovascular graft of claim 21 wherein the inflation medium is a curable biocompatible material having a cure time from about three to about twenty minutes and a post-cure elastic modulus from about 50 to about 400 psi.

7. An endovascular graft comprising:

a graft body section having a proximal end and a distal end;

a proximal connector member affixed to the proximal end of the graft body section, the proximal connector member comprising one or more proximal connector member connector elements;

a proximal stent comprising one or more proximal stent connector elements coupled to the one or more proximal connector member connector elements;

the proximal connector member comprises a serpentine ring comprising apices, wherein the number of proximal connector member apices is n; and

the proximal stent comprises a first region and a second region, the first and second regions each comprising a serpentine ring having apices, and wherein the number of proximal stent first region apices is n and the number of proximal stent second region apices is n/2.

23. An endovascular graft comprising:

a graft body section having a proximal end and a distal end;

a proximal connector member affixed to the proximal end of the graft body section, the proximal connector member comprising one or more cantilevered connector elements;

a proximal stent comprising one or more distally oriented barbs and comprising one or more proximal, cantilevered stent connector elements affixed coupled to the one or more proximal connector member connector elements,

a distal connector member affixed to the distal end of the graft body section, the distal connector member comprising one or more connector elements,

a distal stent comprising one or more proximally oriented barbs and comprising one or more distal stent connector elements coupled to the one or more distal connector member connector elements,

one or more coupling members, wherein;

the one or more proximal connector member connector elements and the one or more distal connector member connector elements each comprises a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

the one or more proximal stent connector elements and the one or more distal stent connector elements each comprises a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

the one or more coupling members couple the one or more proximal connector member connector elements to the one or more proximal stent connector elements; and

the one or more coupling members couple the one or more distal connector member connector elements to the one or more distal stent connector elements; and

an inflatable cuff disposed at each of the proximal and distal ends of the graft body section, wherein the graft body section comprises an inflatable channel in fluid communication with the proximal and distal cuffs.

24. The endovascular graft of claim 23 wherein the at least one of the inflatable channel, the distal inflatable cuff, and the proximal inflatable cuff contains an inflation medium.

25. The endovascular graft of claim 23 wherein the graft body section comprises ePTFE.

26. The endovascular graft of claim 23 wherein the one or more proximal stent barbs or the one or more distal stent barbs are integrally formed with their respective stents and have a length from about 1 mm to about 5 mm.

27. An endovascular graft comprising:

a main body portion with a distal end and a proximal end with a connector member disposed on the proximal end, the connector member comprising one or more cantilevered connector elements;

a proximal stent comprising one or more distally oriented barbs and comprising one or more proximal, cantilevered stent connector elements, wherein the one or more proximal stent connector elements are coupled to the one or more connector member connector elements;

a first bifurcated portion and a second bifurcated portion forming a continuous lumen with the main body portion, said lumen configured to confine a flow of fluid therethrough;

a distal connector member disposed on distal ends of each of the first and second bifurcated portions, the distal connector members each comprising one or more connector elements,

one or more distal stents comprising one or more proximally oriented barbs and comprising one or more distal stent connector elements, wherein the one or more distal stent connector elements are coupled to the one or more distal connector member connector elements on one or both of the first and second bifurcated portions;

one or more coupling members, wherein;

the one or more proximal connector member connector elements and the one or more distal connector member connector elements each comprises a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

the one or more proximal stent connector elements and the one or more distal stent connector elements each comprises a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

the one or more coupling members couple the one or more proximal connector member connector elements to the one or more proximal stent connector elements; and

the one or more coupling members couple the one or more distal connector member connector elements to the one or more distal stent connector elements;

at least one inflatable channel extending from one or both of the first and second bifurcated portions to the main body portion;

at least one inflatable cuff disposed at a proximal end of the main body portion; and

an inflatable cuff disposed at a distal end of one or both of the first and second bifurcated portions, wherein

each of the at least one inflatable channel, at least one proximal inflatable cuff, and distal inflatable cuffs are in fluid communication with each other.

28. The endovascular graft of claim 27 wherein the wherein at least one of the inflatable channel, the first bifurcated portion distal inflatable cuff, the second bifurcated portion distal inflatable cuff and the proximal inflatable cuff contains an inflation medium.

29. The endovascular graft of claim 27 wherein the main body portion and the first and second bifurcated portions comprises ePTFE.

30. The endovascular graft of claim 27 wherein the one or more proximal stent barbs or the one or more distal stent barbs are integrally formed in their respective stents and have a length from about 1 mm to about 5 mm.

31. An endovascular graft comprising:

a graft body section having a proximal end and a distal end;

a proximal connector member affixed to the proximal end of the graft body section, the proximal connector member comprising one or more proximal connector member connector elements, the one or more proximal connector member connector elements comprising a proximal end and a distal end and shoulder portions at the proximal and distal ends;

a proximal stent comprising one or more proximal stent connector elements, the one or more proximal stent connector elements comprising a proximal end and a distal end and shoulder portions at the proximal and distal ends, and

one or more coupling members coupling the one or more proximal connector member connector elements to the one or more proximal stent connector elements to space the proximal stent proximal to the proximal end of the graft body.

32. The endovascular graft of claim 31 wherein the coupling member is a wire coil.

33. An endovascular graft comprising:

a graft body section having a proximal end and a distal end;

a proximal connector member affixed to the proximal end of the graft body section, the proximal connector member comprising one or more connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

a proximal stent comprising one or more distally oriented barbs and comprising one or more proximal stent connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

one or more coupling members coupling the one or more proximal connector member connector elements to the one or more proximal stent connector elements;

a distal connector member affixed to the distal end of the graft body section, the distal connector member comprising one or more connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

a distal stent comprising one or more proximally oriented barbs and comprising one or more distal stent connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

one or more coupling members coupling the one or more distal connector member connector elements to the one or more distal stent connector elements; and

an inflatable cuff disposed at each of the proximal and distal ends of the graft body section, wherein the graft body section comprises an inflatable channel in fluid communication with the proximal and distal cuffs.

34. An endovascular graft comprising:

a main body portion with a distal end and a proximal end with a connector member disposed on the proximal end, the connector member comprising one or more connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

a proximal stent comprising one or more distally oriented barbs and comprising one or more proximal stent connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

one or more coupling members coupling the one or more proximal connector member connector elements to the one or more proximal stent connector elements;

a first bifurcated portion and a second bifurcated portion forming a continuous lumen with the main body portion, said lumen configured to confine a flow of fluid therethrough;

a distal connector member disposed on distal ends of each of the first and second bifurcated portions, the distal connector members each comprising one or more connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

one or more distal stents comprising one or more proximally oriented barbs and comprising one or more distal stent connector elements comprising a proximal end and a distal end and wherein opposing shoulder portions are disposed at each of the proximal and distal ends;

one or more coupling members coupling the one or more distal connector member connector elements to the one or more distal stent connector elements on one or both of the first and second bifurcated portions;

at least one inflatable channel extending from one or both of the first and second bifurcated portions to the main body portion;

at least one inflatable cuff disposed at a proximal end of the main body portion; and

an inflatable cuff disposed at a distal end of one or both of the first and second bifurcated portions,

wherein each of the at least one inflatable channel, at least one proximal inflatable cuff, and distal inflatable cuffs are in fluid communication with each other.