Endovascular stent-graft with fatigue-resistant lateral tube

• US 10,485,684 B2
• Filed: 12/16/2015
• Issued: 11/26/2019
• Est. Priority Date: 12/18/2014
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Marmur, Yaniv, Nae, Nir Shalom, Shalev, Alon
• Primary Examiner(s): McEvoy, Thomas M
• Application Number:
  US15/105,106
• Publication Number:
  US 20170273809A1
• Time in Patent Office: 1,441 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2002/061 provided with means for allowing access to secondary lumens

Abstract

A stent-graft (20) comprises strut members (30) and a graft member (32), which is fixed to the strut members (30). The strut members (30) and the graft member (32) are arranged so as to define, when the stent-graft (20) is in a radially-expanded state: a main tube (40), which is shaped so as to define a main lumen (42); and a lateral tube (50), which (a) has (i) a distal end (52) and (ii) a proximal end (54) that is joined to a lateral wall (56) of the main tube (40) at a junction (60), (b) is shaped so as to define a lateral lumen (62) that is in fluid communication with the main lumen (42), and (c) defines a central longitudinal axis (64). The strut members (30) that define the lateral tube (50) are shaped so as to define two to four non-contiguous arcuate members (70), which (a) are centered around the central longitudinal axis (64), and (b) collectively subtend at least 150 degrees around the central longitudinal axis (64).

Claims

1. Apparatus comprising an endovascular stent-graft, which is configured to transition from a radially-compressed delivery state to a radially-expanded state, and which comprises:

a plurality of structural strut members; and

a graft member, which comprises one or more substantially blood-impervious flexible sheets, and which is fixed to the structural strut members,

wherein the structural strut members and the graft member are arranged so as to define, when the stent-graft is in the radially-expanded state;

a main tube, which is shaped so as to define a main lumen, and

a lateral tube, which (a) has (i) a distal end and (ii) a proximal end that is joined to a lateral wall of the main tube at a junction, (b) is shaped so as to define a lateral lumen that is in fluid communication with the main lumen, and (c) defines a central longitudinal axis, and

wherein, when the stent-graft is in the radially-expanded state, the structural strut members that define the lateral tube are shaped so as to define two to four non-contiguous arcuate members, which (a) are centered around the central longitudinal axis, (b) define respective arcs of a common circle, (c) collectively subtend at least 150 degrees around the central longitudinal axis, and (d) have respective pairs of arcuate-member ends, wherein all of the arcuate-member ends of all of the arcuate members are disposed at a same axial position along the lateral tube, wherein the same axial position is distal to the junction along the lateral tube.

2. The apparatus according to claim 1, wherein the arcuate members collectively subtend at least 180 degrees around the central longitudinal axis, when the stent-graft is in the radially-expanded state.

3. The apparatus according to claim 2, wherein the arcuate members collectively subtend at least 210 degrees around the central longitudinal axis, when the stent-graft is in the radially-expanded state.

4. The apparatus according to claim 1, wherein at least one of the arcuate members alone subtends at least 60 degrees around the central longitudinal axis, when the stent-graft is in the radially-expanded state.

5. The apparatus according to claim 1, wherein when the main tube is in a radially-expanded state thereof and the lateral tube is in a compressed delivery state thereof, the arcuate members define a portion of a generally tubular outer surface of the main tube.

6. The apparatus according to claim 1, wherein the apparatus further comprises a branching stent-graft, which is configured to form a blood-tight seal with the lateral tube, when the stent-graft is in the radially-expanded state and the branching stent-graft is in a radially-expanded state.

7. The apparatus according to claim 1, wherein a ratio of (a) an average circumference of the main tube and (b) an average circumference of the lateral tube is between 1:

1 and 5;

1, when the stent-graft is in the radially-expanded state.

8. The apparatus according to claim 1, wherein a length of the lateral tube is between 10% and 30% of an average circumference of the lateral tube, when the stent-graft is in the radially-expanded state.

9. The apparatus according to claim 1, wherein a circumference of the lateral tube at the proximal end of the lateral tube is between 5% and 30% greater than a circumference of the lateral tube at the distal end of the lateral tube, when the stent-graft is in the radially-expanded state.

10. The apparatus according to claim 1, wherein an angle between the central longitudinal axis of the lateral tube and a central longitudinal axis of the main tube is greater than 80 degrees, when the stent-graft is in the radially-expanded state.

11. The apparatus according to claim 1, wherein the main tube has proximal and distal ends, and wherein a circumference of the proximal end of the main tube is 3 to 10 cm, when the stent-graft is in the radially-expanded state.

12. The apparatus according to claim 11, wherein a circumference of the distal end of the main tube is 6 to 12 cm, when the stent-graft is in the radially-expanded state.

13. The apparatus according to claim 1, wherein the one or more flexible sheets comprise a material selected from the group consisting of:

polyethylene terephthalate and expanded polytetrafluoroethylene (PTFE).

14. The apparatus according to claim 1, wherein the arcuate members are arranged so as to provide respective circumferential gaps between circumferentially-adjacent ones of the arcuate members, when the stent-graft is in the radially-expanded state.

15. The apparatus according to claim 14, wherein the arcuate members collectively subtend no more than 350 degrees around the central longitudinal axis, when the stent-graft is in the radially-expanded state.

16. The apparatus according to claim 14, wherein each of the circumferential gaps measures at least 10 degrees, when the stent-graft is in the radially-expanded state.

17. The apparatus according to claim 14, wherein respective areas of the lateral tube, which (a) circumferentially correspond with the gaps and (b) extend from the axial position of the arcuate members along at least 50% of a distance between the axial position of the arcuate members and the junction, are free from the structural strut members, when the stent-graft is in the radially-expanded state.

18. The apparatus according to claim 1, wherein the structural strut members that define the lateral tube are shaped so as to define respective linking members for the arcuate members, which linking members link the arcuate members to the junction.

19. The apparatus according to claim 18, wherein, when the stent-graft is in the radially-expanded state, the lateral tube is free from the structural strut members, except for the arcuate members and the linking members, in an area that (a) extends entirely around the central longitudinal axis and (b) extends from the distal end of the lateral tube along at least 50% of a distance between the distal end of the lateral tube and the junction.

20. The apparatus according to claim 19, wherein, when the stent-graft is in the radially-expanded state, the lateral tube is free from the structural strut members, except for the arcuate members, the linking members, and any of the structural strut members that surround the proximal end of the lateral tube at the junction.

21. The apparatus according to claim 18, wherein an average length of the linking members equals at least 80% of a length of the lateral tube, when the stent-graft is in the radially-expanded state.

22. The apparatus according to claim 18, wherein, when the stent-graft is in the radially-expanded state, respective linking-member points on the linking members and respective juncture points between the linking members and the arcuate members define respective lines, wherein the respective lines form respective angles with the respective arcuate members, wherein the respective angles have an average of 30 to 90 degrees, and wherein the respective linking-member points on the linking members are at 30% of a distance between an axial position of the arcuate members and the junction.

23. The apparatus according to claim 22, wherein an average length of the linking members equals at least 80% of a length of the lateral tube, when the stent-graft is in the radially-expanded state.

24. The apparatus according to claim 22, wherein the average of the respective angles is 85 to 90 degrees.

25. The apparatus according to claim 18, wherein the linking members form respective angles with the respective arcuate members, and wherein the respective angles have an average of 30 to 90 degrees, when the stent-graft is in the radially-expanded state.

26. The apparatus according to claim 25, wherein the average of the respective angels is 85 to 90 degrees.

27. The apparatus according to claim 18, wherein each of the linking members is connected to its respective arcuate member at a juncture point at a location along the arcuate member that is within a number of degrees of a circumferential center of the arcuate member around the central circumferential axis, which number of degrees is equal to 40% of a total number of degrees of the arcuate member.

28. The apparatus according to claim 27, wherein the location along the arcuate member is at the circumferential center of the arcuate member.

29. The apparatus according to claim 18, wherein, when the stent-graft is in the radially-expanded state, one or more of the structural strut members (a) completely surround the proximal end of the lateral tube at the junction and (b) are connected to the linking members.

30. The apparatus according to claim 1, wherein one or more of the structural strut members completely surround the proximal end of the lateral tube at the junction, when the stent-graft is in the radially-expanded state.

31. The apparatus according to claim 30,

wherein the structural strut members that define the main tube are shaped so as a plurality of circumferential stent springs, each of which is shaped so as to define a plurality of stent cells, and

wherein one of the stent cells of one of the circumferential stent springs is defined by the one or more of the structural strut members that completely surround the proximal end of the lateral tube at the junction, when the stent-graft is in the radially-expanded state.

32. The apparatus according to claim 31, wherein the stent cells of the one of the circumferential stent springs are diamond-shaped, when the stent-graft is in the radially-expanded state.

33. The apparatus according to claim 32, wherein the diamond-shaped stent cells have respective, different dimensions, when the stent-graft is in the radially-expanded state.

34. The apparatus according to claim 33, wherein a largest one of the diamond-shaped stent cells is at least 100% greater in surface area than a smallest one of the diamond-shaped stent cells, which largest one of the diamond-shaped stent cells is the one of the stent cells that is defined by the one or more of the structural strut members that completely surround the proximal end of the lateral tube at the junction, when the stent-graft is in the radially-expanded state.

35. The apparatus according to claim 34,

wherein the lateral tube is a first lateral tube, the distal and proximal ends are first distal and proximal ends, the junction is a first junction, the lateral lumen is a first lateral lumen, the central longitudinal axis is a first central longitudinal axis, and the arcuate members are first arcuate members,

wherein the structural strut members and the graft member are arranged so as to define, when the stent-graft is in the radially-expanded state, a second lateral tube, which (a) has (i) a second distal end and (ii) a second proximal end that is joined to the lateral wall of the main tube at a second junction, (b) is shaped so as to define a second lateral lumen that is in fluid communication with the main lumen, and (c) defines a second central longitudinal axis,

wherein, when the stent-graft is in the radially-expanded state, the structural strut members that define the second lateral tube are shaped so as to define two to four non-contiguous second arcuate members, which (a) are centered around the second central longitudinal axis, and (b) collectively subtend at least 150 degrees around the second central longitudinal axis, and

wherein the smallest one of the diamond-shaped stent cells completely surrounds the second proximal end of the second lateral tube at the second junction, when the stent-graft is in the radially-expanded state.

37. The apparatus according to claim 1, wherein the arcuate members are disposed with 3 mm of a distal end of a portion of the graft member that defines the lateral tube, when the stent-graft is in the radially-expanded state.

38. The apparatus according to claim 1, wherein an angle between the central longitudinal axis of the lateral tube and a central longitudinal axis of the main tube is between 60 and 80 degrees, when the stent-graft is in the radially-expanded state.

39. The apparatus according to claim 1, wherein an angle between the central longitudinal axis of the lateral tube and a central longitudinal axis of the main tube is between 30 and 60 degrees, when the stent-graft is in the radially-expanded state.

36. A method for treating a subject, comprising:

transvascularly introducing an endovascular stent-graft into a blood vessel of the subject while the stent-graft is in a radially-compressed delivery state, which stent-graft comprises (a) a plurality of structural strut members, and (b) a graft member, which comprises one or more substantially blood-impervious flexible sheets, and which is fixed to the structural strut members; and

transitioning the stent-graft to a radially-expanded state, in which;

the structural strut members and the graft member are arranged so as to define (x) a main tube, which is shaped so as to define a main lumen, and (y) a lateral tube, which (a) has (i) a distal end and (ii) a proximal end that is joined to a lateral wall of the main tube at a junction, (b) is shaped so as to define a lateral lumen that is in fluid communication with the main lumen, and (c) defines a central longitudinal axis, and

the structural strut members that define the lateral tube are shaped so as to define two to four non-contiguous arcuate members, which (a) are centered around the central longitudinal axis, (b) define respective arcs of a common circle, (c) collectively subtend at least 150 degrees around the central longitudinal axis, and (d) have respective pairs of arcuate-member ends, wherein all of the arcuate-member ends of all of the arcuate members are disposed at a same axial position along the lateral tube, wherein the same axial position is distal to the junction along the lateral tube.