Apparatus for closure of a lumen and methods of using the same

• US 8,979,892 B2
• Filed: 07/08/2010
• Issued: 03/17/2015
• Est. Priority Date: 07/09/2009
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/383,128
• Publication Number:
  US 20120172929A1
• Time in Patent Office: 1,713 Days
• Field of Search: 606/213, 623/1.16, 623/1.11, 623/1.1, 623/1.15, 623/1.18, 623/1.23, 623/1.44, 623/1.49
• US Class Current: 606/213
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A generally tubular endovascular prosthesis (100) is configured to transition between a radially-compressed state and a radially-expanded state. The prosthesis (100) includes a first generally cylindrical structural portion (101), which has first and second ends (102, 103), and a second generally cylindrical structural portion (104), which has first and second ends (105, 106). The first end (102) of the first structural portion (101) and the first end (105) of the second structural portion (104) meet each other at a juncture (107). The prosthesis (100) is configured to transition from (a) an initial folded state, in which the second structural portion (104) is folded into the first structural portion (101) at the juncture (107), to (b) an unfolded state, in which the second structural portion (104) is no longer positioned within the first structural portion (101), and the second end (103) of the first structural portion (101) and the second end (106) of the second structural portion (104) are positioned at opposite ends of the prosthesis (100). Other embodiments are also described.

Claims

1. Apparatus comprising a generally tubular endovascular prosthesis, which comprises structural stent elements, and which is configured to transition between a radially-compressed state and a radially-expanded state, the prosthesis comprising:

a first structural portion, (a) which comprises a plurality of the structural stent elements, (b) which has first and second ends, and (c) which is generally cylindrical when the prosthesis assumes the radially-expanded state; and

a second structural portion, (a) which comprises a plurality of the structural stent elements, (b) which has first and second ends, and (c) which is generally cylindrical when the prosthesis assumes the radially-expanded state,

wherein the first end of the first structural portion and the first end of the second structural portion meet each other at a juncture, and

wherein the prosthesis is configured to transition from (a) an initial folded state, in which the second structural portion is folded into the first structural portion at the juncture, such that the second end of the second structural portion axially extends in a direction from the juncture toward the second end of the first structural portion, to (b) an unfolded state, in which the second structural portion is no longer positioned within the first structural portion, and the second end of the first structural portion and the second end of the second structural portion are positioned at opposite ends of the prosthesis.

2. The apparatus according to claim 1, wherein the prosthesis further comprises a blood-impervious fluid flow guide, which at least partially covers the second structural portion.

3. The apparatus according to claim 2, wherein the fluid flow guide is biodegradable.

4. The apparatus according to claim 1, wherein the second structural portion is shaped so as to define an elongated opening that extends axially along at least a portion of the second structural portion, when the prosthesis assumes the radially-expanded state.

5. The apparatus according to claim 4, wherein an arc of the second structural portion circumscribed by the elongated opening is less at a first end of the elongated opening than at a second end of the elongated opening, which second end of the elongated opening is closer to the second end of the second structural portion than the first end of the elongated opening is to the second end of the second structural portion.

6. The apparatus according to claim 5, wherein the arc monotonically increases from the first end of the elongated opening to the second end of the elongated opening.

7. The apparatus according to claim 1, wherein the first end of the first structural portion is shaped so as to define a plurality of first loops, wherein the first end of the second structural portion is shaped so as to define a plurality of second loops, and wherein the first loops are interconnected with the second loops so as to define the juncture.

8. The apparatus according to claim 1, wherein the second structural portion is flared radially outward at the second end thereof, when the prosthesis assumes the radially-expanded and unfolded states.

9. The apparatus according to claim 1, further comprising a first elongated member, which is initially in contact with the first structural portion, wherein the first elongated member and the prosthesis are arranged such that axial motion of the first elongated member with respect to the prosthesis results in radial expansion of the first structural portion.

10. The apparatus according to claim 9, wherein the first elongated member comprises a first generally tubular sheath, which is initially externally positioned surrounding at least a portion of the first structural portion, such that the first sheath initially holds the prosthesis in the radially-compressed state, and wherein the first sheath is slidable with respect to the first structural portion.

11. The apparatus according to claim 9, further comprising a second elongated member, which is initially in contact with the second structural portion, wherein the second elongated member and the prosthesis are arranged such that axial motion of the second elongated member with respect to the prosthesis transitions the prosthesis to the unfolded state.

12. The apparatus according to claim 11, wherein the second elongated member and the prosthesis are arranged such that the axial motion of the second elongated member with respect to the prosthesis transitions the prosthesis to the unfolded state and results in radial expansion of the second structural portion.

13. The apparatus according to claim 11, wherein the second elongated member is initially positioned between the second structural portion and a central longitudinal axis of the prosthesis, and wherein the second elongated member and the second structural portion are configured such that the second elongated member is frictionally adherent to the second structural portion.

14. The apparatus according to claim 1, wherein the structural stent elements comprise a super-elastic alloy.

15. The apparatus according to claim 14, wherein the super-elastic alloy comprises a material selected from the group consisting of:

a braided super-elastic alloy, and a woven super-elastic alloy.

16. The apparatus according to claim 1, wherein the prosthesis does not comprise a blood-impervious fluid flow guide that at least partially covers the second structural portion.

17. A method for providing hemostasis to a puncture site in a body lumen, the method comprising:

providing a generally tubular endovascular prosthesis, which (1) includes structural stent elements, (2) is configured to transition between a radially-compressed state and a radially-expanded state, and (3) includes (i) a first structural portion, (a) which includes a plurality of the structural stent elements, (b) which has first and second ends, and (c) which is generally cylindrical when the prosthesis assumes the radially-expanded state, and (ii) a second structural portion, (a) which comprises a plurality of the structural stent elements, (b) which has first and second ends, and (c) which is generally cylindrical when the prosthesis assumes the radially-expanded state, wherein the first end of the first structural portion and the first end of the second structural portion meet each other at a juncture;

introducing the prosthesis into the lumen via the puncture site, while the prosthesis is in the radially-compressed state and an in an initial folded state, in which the second structural portion is folded into the first structural portion at the juncture, such that the second end of the second structural portion axially extends in a direction from the juncture toward the second end of the first structural portion; and

while the prosthesis is within the lumen, transitioning the prosthesis (a) from the radially-compressed state to the radially-expanded state, and (b) from the initial folded state to an unfolded state, in which unfolded state the second structural portion is no longer positioned within the first structural portion, and the second end of the first structural portion and the second end of the second structural portion are positioned at opposite ends of the prosthesis, such that a portion of the second portion extends alongside the puncture site.

18. The method according to claim 17, wherein providing the prosthesis comprises providing the prosthesis in which the first end of the first structural portion is shaped so as to define a plurality of first loops, the first end of the second structural portion is shaped so as to define a plurality of second loops, and the first loops are interconnected with the second loops so as to define the juncture.

19. The method according to claim 17, wherein transitioning the prosthesis from the radially-compressed state to a radially-expanded state comprises radially expanding the first structural portion by axially moving a first elongated member that is initially in contact with the first structural portion.

20. The method according to claim 19, wherein the first elongated member includes a first generally tubular sheath, which is initially externally positioned surrounding at least a portion of the first structural portion, such that the first sheath initially holds the prosthesis in the radially-compressed state, and wherein radially expanding the first structural portion comprises removing the first sheath from the at least a portion of the first structural portion.

21. The method according to claim 20, wherein removing comprises sliding the first sheath with respect to the first structural portion.

22. The method according to claim 19, wherein transitioning the prosthesis from the initial folded state to the unfolded state comprises axially moving a second elongated member that is initially in contact with the second structural portion.

23. The method according to claim 22, wherein transitioning the prosthesis from the radially-compressed state to the radially-expanded state comprises radially expanding the second structural portion by axially moving the second elongated member.

24. The method according to claim 22, wherein providing the prosthesis comprises providing the prosthesis such that the second elongated member is initially positioned between the second structural portion and a central longitudinal axis of the prosthesis.

25. The method according to claim 17, wherein providing the prosthesis comprises providing the prosthesis including a blood-impervious fluid flow guide, which at least partially covers the second structural portion.

26. The method according to claim 17, wherein providing the prosthesis comprises providing the prosthesis in which the second structural portion is shaped so as to define an elongated opening that extends axially along at least a portion of the second structural portion, when the prosthesis assumes the radially-expanded state.

27. The method according to claim 17, wherein providing the prosthesis comprises providing the prosthesis in which the structural stent elements comprise a super-elastic alloy.

28. The method according to claim 27, wherein providing the prosthesis comprises providing the prosthesis in which the super-elastic alloy includes a material selected from the group consisting of:

a braided super-elastic alloy, and a woven super-elastic alloy.

29. The method according to claim 17, wherein introducing the prosthesis comprises positioning the prosthesis such that the juncture is at a distance from the puncture site of between 0.5 and 3 cm.

30. The method according to claim 17, wherein the prosthesis does not include a blood-impervious fluid flow guide that at least partially covers the second structural portion, and wherein providing the prosthesis comprises providing the prosthesis that does not include a blood-impervious fluid flow guide that at least partially covers the second structural portion.

31. The method according to claim 17, wherein transitioning comprises transitioning the prosthesis to the unfolded state such that the portion of the second portion extends alongside the puncture site, and the structural stent elements of the second portion provide at least partial tissue scaffolding to enable the hemostasis at the puncture site, and to provide a surface that stimulates blood coagulation.