Uncaging stent

• US 10,271,976 B2
• Filed: 07/18/2018
• Issued: 04/30/2019
• Est. Priority Date: 05/16/2016
• Status: Active Grant

• Current Assignee: Elixir Medical Corporation
• Original Assignee: Elixir Medical Corporation
• Inventors: Sirhan, Motasim, Yan, John, Bhat, Vinayak, Paraschac, Joseph, Cryer, Brett, Serna, Benjamyn
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US16/039,194
• Publication Number:
  US 20180318113A1
• Time in Patent Office: 286 Days
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0071 : breakable or frangible

Abstract

A stent (scaffold) or other luminal prosthesis comprising circumferential structural elements which provides high strength after deployment and allows for scaffold to uncage, and/or allow for scaffold or luminal expansion thereafter. The circumferential scaffold may be formed from degradable material, or may be formed from non-degradable material and will be modified to expand and/or uncage after deployment.

Claims

1. An endoluminal prosthesis comprising:

a scaffold comprising a plurality of axially adjacent circumferential rings, said scaffold being configured to expand from a crimped configuration to an expanded configuration;

wherein at least one first element from a first ring is joined to a second element from an adjacent second ring, wherein an end of a third element from the first ring is detachably attached to said second ring, wherein the first element from the said first ring and second element from the said second ring are configured to remain attached after the third element detaches, and wherein each said detachment of the third element provides a separation of the third element from said second ring and provides a discontinuity in the circumferential path of the first circumferential ring, and wherein said third element is configured to detach after expansion of said scaffold in a physiologic environment.

2. An endoluminal prosthesis as in claim 1, wherein said first and second elements are joined through an axial link.

3. An endoluminal prosthesis as in claim 2, wherein the third detachably attached element is attached to said axial link.

4. An endoluminal prosthesis as in claim 2, wherein the axial link is configured to remain intact after the third element detaches.

5. An endoluminal prosthesis as in claim 1, wherein the detachable attachment of the third element comprises a separation region configured to form at least one discontinuity when said third element detaches after expansion in a physiologic environment.

6. An endoluminal prosthesis as in claim 5, wherein the separation region comprises a biodegradable polymer and/or adhesive which degrades in the physiologic environment.

7. An endoluminal prosthesis as in claim 5, wherein the separation region comprises a female portion having spaced-apart elements and a male portion configured to fit in between the spaced-apart elements of the female portion.

8. An endoluminal prosthesis as in claim 7, wherein either the male portion or the female is at the end of the detachable third element.

9. An endoluminal prosthesis as in claim 5, wherein the separation region comprises a socket portion and a ball portion configured to fit in the socket portion.

10. An endoluminal prosthesis as in claim 5, wherein the separation region is configured to provide a surface area and/or feature sufficient to provide adhesion or friction to prevent premature separation upon expansion of said scaffold.

11. An endoluminal prosthesis as in claim 1, wherein at least some of the elements comprise struts.

12. An endoluminal prosthesis as in claim 1, wherein at least some of the elements comprise crowns joining struts.

13. An endoluminal prosthesis as in claim 1, wherein at least some rings each have a number of third elements ranging from 1 to 4.

14. An endoluminal prosthesis as in claim 1, wherein the first element is adjacent to the third element on the same ring.

15. An endoluminal prosthesis as in claim 1, wherein the scaffold further comprises at least one drug.

16. An endoluminal prosthesis as in claim 1, wherein said scaffold is formed from a non-degradable material.

17. An endoluminal prosthesis as in claim 16, wherein said non-degradable material comprises a metal or metal alloy material.

18. An endoluminal prosthesis as in claim 1, wherein the detachable third element is attached through key and lock portions, which are aligned in a circumferential axis.

20. An endoluminal prosthesis as in claim 1 or claim 19, wherein said circumferential rings are formed from a bent wire to form a helical scaffold.

25. An endoluminal prosthesis as in claim 17 or 15, wherein said metal or metal alloys comprises stainless steel, Cobalt alloy, cobalt chrome, platinum, platinum iridium, platinum chromium, platinum rhodium, or nickel titanium.

29. An endoluminal prosthesis as in claim 15 or 28, wherein the drug comprises an m-Tor inhibitor comprising sirolimus, novolimus, biolimus, everolimus, ridaforolimus, temsirolimus, or zotarolimus.

30. An endoluminal prosthesis as in claim 1 or claim 19, wherein the scaffold further comprises a coating.

31. An endoluminal prosthesis as in claim 30, wherein said coating comprises polylactide, poly-L-lactic acid, poly-DL-lactide, polylactide-co-glycolide, poly(lactic-co-glycolide0, poly(n-butylmethacrylate), ethylene vinyl acetate, poly(ethylene-co-vinyl acetate), polyvinyl pyrrolidone, parylene, PVDF-HFP poly(vinylidene fluoride hexafluoropropylene), polystyrene, poly(L-lactide-co-epsilon-caprolactone, or poly(styrene-b-isobutylene-b-styrene).

35. An endoluminal prosthesis as in claim 1 or claim 19, wherein said scaffold has a pattern comprising a serpentine, zigzag, or helical, open cell or closed cell design.

36. An endoluminal prosthesis as in claim 1 or claim 19, wherein said detachable element is joined by, covered by or embedded in a material.

37. An endoluminal prosthesis as in claim 36, wherein said material comprises a biodegradable polymer and/or adhesive which degrades in a physiologic environment.

38. An endoluminal prosthesis as in claim 37, wherein said biodegradable polymer and/or adhesive comprising polylactide, poly-L-lactide, poly-DL-lactide, polylactide-co-glycolide, poly(L-lactic-co-glycolide), poly(ethylene-co-vinyl acetate), poly(L-lactide-co-epsilon-caprolactone), poly(DL-lactide-co-glycolide), poly(lactide-co-caprolactone), poly(D-lactide), polyglycolide, polycaprolactone, polyhydroxyalkanoate, polyvinyl alcohol, polyvinyl acetate, or cyanoacrylate.

39. An endoluminal prosthesis as in claim 1 or claim 19, wherein said prosthesis following expansion from a crimped configuration to an expanded configuration in a physiologic environment has sufficient strength to support a body lumen with low recoil from said expanded configuration.

40. An endoluminal prosthesis as in claim 1 or 19, wherein said prosthesis further comprises radiopaque markers.

41. An endoluminal prosthesis as in claim 1 or 19, wherein said prosthesis has a helical backbone design.

19. An endoluminal prosthesis comprising:

a scaffold comprising a plurality of axially adjacent circumferential rings, said scaffold being configured to expand from a crimped configuration to an expanded configuration;

wherein at least some axially adjacent first and second circumferential rings comprise elements joining said adjacent rings and forming a junction, wherein an end of one element of said first circumferential ring is detachably attached at said junction and other elements of said junction are configured to remain joined after the one element detaches, wherein said detachable element is configured to detach after expansion of the scaffold in a physiologic environment and, wherein each said one element detachment provides a separation of said one element from said second adjacent ring and provides a discontinuity in a circumferential path of the first circumferential ring.

21. An endoluminal prosthesis as in claim 19, wherein said adjacent rings are joined through an axial link.

22. An endoluminal prosthesis as in claim 21, wherein the one detachable element is attached to said axial link.

23. An endoluminal prosthesis as in claim 19, wherein each circumferential ring comprises two elements forming said junction, with said one element detachably connected to said junction.

24. An endoluminal prosthesis as in claim 19, wherein said scaffold is formed from a non-degradable material comprising a metal or metal alloy.

26. An endoluminal prosthesis as in claim 19, wherein said detachable element attaches through a male and female connection.

27. An endoluminal prosthesis as in claim 7 or 26, wherein said male and female connection comprises a cap and pin, cap and disc, or a ball and socket.

28. An endoluminal prosthesis as in claim 19, wherein the scaffold further comprises at least one drug.

32. An endoluminal prosthesis as in claim 19, wherein at least some of the elements comprise struts.

33. An endoluminal prosthesis as in claim 19, wherein at least some of the elements comprise crowns joining struts.

34. An endoluminal prosthesis as in claim 19, wherein the detachable attachment of said one element comprises a biodegradable polymer and/or adhesive which degrades in the physiologic environment.