Delivery system for placement of prosthesis at luminal os

• US 20060079952A1
• Filed: 10/13/2004
• Published: 04/13/2006
• Est. Priority Date: 10/13/2004
• Status: Active Grant

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Anvil Medical, Inc.
• Inventors: Kaplan, Aaron V., Vargas, Jaime
• Granted Patent: US 7,717,953 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An embodiment of the invention provides a prosthesis delivery system comprising a delivery catheter having an expandable member and a prosthesis carried over the expandable member. The prosthesis includes a radially expandable scaffold section and at least two anchors extending axially from an end thereof, and means for capturing at least the anchors to prevent the anchors from divaricating from the expandable member as the catheter is advanced through a patient'"'"'s vasculature.

Claims

1. A method for delivering a luminal prosthesis, said method comprising:

providing a delivery catheter which carries the prosthesis, wherein the prosthesis comprises a radially expansible scaffold section and at least two anchors extending axially from an end thereof;

advancing the delivery catheter to position the prosthesis at a target location in a body lumen, wherein at least the anchors are radially constrained to prevent divarication from the delivery catheter;

releasing the radial constraint; and

expanding the scaffold within the lumen.

2. A method as in claim 1, wherein releasing and expanding occur simultaneously or releasing occurs during expanding.

3. A method as in claim 2, wherein the radial constraint comprises folds of a balloon covering the anchors, wherein the constraint is released as the balloon is inflated.

4. A method as in claim 2, wherein the radial constraint comprises a cuff which extends over the anchors.

5. A method as in claim 2, wherein the constraint comprises a tether which ties the anchors together, wherein the tether is broken by expansion of the scaffold.

6. A method as in claim 1, wherein the radial constraint is released prior to expanding the scaffold.

7. A method as in claim 6, wherein the radial constraint comprises a cuff which extends over the anchors, wherein the cuff is withdrawn from the anchors prior to expansion of the scaffold.

8. A method as in claim 7, wherein prior to withdrawal, the cuff extends over at least a portion of the scaffold.

9. A method as in claim 6, wherein the radial constraint comprises a tether which ties the anchors together, wherein the tether is withdrawn prior to expansion.

10. A method as in claim 1, wherein expanding the scaffold deforms the anchors to circumscribe at least a portion of the main-body lumen.

11. A method as in claim 1, wherein the prosthesis is deployed across an os opening from a main body lumen to a branch body lumen, the method further comprising:

positioning the prosthesis so that the scaffold lies within the branch body and the at least two anchors extend into the main body lumen; and

circumferentially deforming the anchors to circumscribe at least a portion of the main vessel wall and open a passage through the anchors.

12. A method as in claim 10, wherein at least three circumferential anchors extend into the main body lumen.

13. A method as in claim 10, wherein positioning the prosthesis comprises aligning a visible marker on at least one of the prosthesis and a delivery balloon with the os.

14. A method as in claim 10, wherein the lumens are blood vessels.

15. A method as in claim 10, wherein the scaffold is expanded with a balloon expanded within the scaffold.

16. A method as in claim 15, wherein the anchors are deformed by expanding a balloon positioned transversely through the anchors.

17. A method as in claim 16, wherein the scaffold and anchors are expanded and deformed by the same balloon.

18. A method as in claim 16, wherein the scaffold and anchors are expanded and deformed by different balloons.

19. A method as in claim 11, further comprising deploying a second prosthesis within the passage through the anchors.

20. A method as in claim 19, wherein the second prosthesis is deployed by a balloon catheter exchanged over a guidewire pre-positioned for deformation of the anchors.

21. A method as in claim 19, wherein the anchors are deformed by deployment of the second prosthesis.

22. A method as in claim 19, wherein the deployed second stent supports the anchors over their lengths from the os over the main body lumen wall.

23. A prosthesis delivery system comprising:

a delivery catheter having an expandable member;

a prosthesis carried over the expandable member, said prosthesis having a radially expandable scaffold section and at least two anchors extending axially from an end thereof; and

means for capturing at least the anchors to prevent the anchors from divaricating from the expandable member as the catheter is advanced through a patient'"'"'s vasculature.

24. A prosthesis delivery system as in claim 23, wherein the capturing means comprises a portion of the expandable member which is folded over the anchors.

25. A prosthesis delivery system as in claim 24, wherein the folds are formed through axial gaps between adjacent anchors.

26. A prosthesis delivery system as in claim 23, wherein the capturing means comprises a cuff.

27. A prosthesis delivery system as in claim 26, wherein the cuff is configured to release the anchors as the expandable member is expanded.

28. A prosthesis delivery system as in claim 26, wherein the cuff is configured to be withdrawn prior to deployment of the expandable member.

29. A prosthesis delivery system as in claim 26, wherein the cuff is configured to shorten axially as it is expanded by the expandable member.

30. A prosthesis delivery system as in claim 26, wherein at least a portion of an interior surface of the cuff comprises a fluoropolymer.

31. A prosthesis delivery system as in claim 26, wherein a distal portion of the cuff has a different durometer than a proximal portion.

32. A prosthesis delivery system as in claim 26, wherein the cuff is folded over the anchors.

33. A prosthesis delivery system as in claim 28, wherein the cuff extends over at least a portion of the scaffold prior to being released.

34. A prosthesis delivery system as in claim 23, wherein the capturing means comprises a tether which circumscribes the proximal portion of the prosthesis.

35. A prosthesis delivery system as in claim 34, wherein the tether is configured to be detached from the anchors prior to expansion of the expandable member.

36. A prosthesis delivery system as in claim 35, wherein the tether is configured to break upon expansion of the expandable member.

37. A prosthesis delivery system as in claim 23, wherein the prosthesis comprises at least three circumferential anchors extending axially from the end of the scaffold.

38. A prosthesis delivery system as in claim 23, wherein the anchors have an axial length which is at least 1.5 times the width of the scaffold prior to radial expansion.

39. A prosthesis delivery system as in claim 23, wherein the anchors have an axial length of at least 2 mm.

40. A prosthesis delivery system as in claim 23, wherein the scaffold comprises a plurality of axially adjacent cells.

41. A prosthesis delivery system as in claim 23, wherein the circumferential anchors are all congruent.

42. A prosthesis delivery system as in claim 23, wherein the circumferential anchors will radially expand when the scaffold is radially expanded.

43. A prosthesis delivery system as in claim 23, wherein the circumferential anchors are adapted to both bend and rotate relative to a control axis of the prosthesis.

44. A prosthesis delivery system as in claim 23, further comprising a radiopaque marker at or near a transition location between the scaffold and the circumferential anchors.

45. A prosthesis delivery system as in claim 23, wherein the system is configured to be mounted on a balloon having a radiopaque marker aligned with a transition location between the scaffold and the circumferential anchors.