Uncaging stent

Patent metadata

Field	Value
Publication number	US-9943426-B2
Application number	US-201715605601-A
Country	US
Kind code	B2
Filing date	May 25, 2017
Priority date	Jul 15, 2015
Publication date	Apr 17, 2018
Grant date	Apr 17, 2018

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.

First claim

What is claimed is:

1. An endoluminal prosthesis comprising:
a scaffold comprising structural elements comprising a plurality of circumferential rings patterned from a non-degradable material, said scaffold being configured to expand from a crimped configuration to an expanded configuration;
wherein at least some of the circumferential rings comprise a plurality of struts joined by crowns;
wherein at least some of the circumferential rings have at least one separation region located in a strut comprising a break or a gap in said strut separating said strut,;
wherein said at least one separation region comprises a lock and key connection comprising a female portion comprising two spaced apart arms and a male portion adapted to fit between the arms of the female portion; and
wherein said at least one separation regions comprises a biodegradable polymer and/or adhesive providing a continuous circumferential path around the scaffold before expansion but said separation region is configured to form at least one discontinuity in said circumferential ring after expansion in a physiologic environment; and
at least portions of two of the circumferential rings remain axially joined after all discontinuities are formed.

2. An endoluminal prosthesis as in claim 1 , wherein portions of all circumferential rings remain axially joined after all discontinuities are formed.

3. An endoluminal prosthesis as in claim 1 , wherein the scaffold separates into two, three, or four segments along the length of the scaffold after all discontinuities are formed, each segment comprising a plurality of partial circumferential rings, wherein each partial ring remains axially connected to an adjacent partial ring.

4. An endoluminal prosthesis as in claim 3 , wherein the separation lines have axial or spiral geometries.

5. An endoluminal prosthesis as in claim 1 , wherein the circumferential rings form a helical scaffold.

6. An endoluminal prosthesis as in claim 1 , wherein each of the at least some circumferential rings has from one to five struts having a separation region.

7. An endoluminal prosthesis as in claim 1 , wherein the at least one separation region is immobilized during expansion but configured to separate after expansion in the physiologic environment.

8. An endoluminal prosthesis as in claim 7 , wherein the connections allow separation at said connection in circumferential, radial, and/or axial directions.

9. An endoluminal prosthesis as in claim 1 , wherein said non-degradable material comprises a metal or a metal alloy material.

10. An endoluminal prosthesis as in claim 9 , wherein the non degradable metal or metal alloy comprises stainless steel, cobalt alloy, cobalt chrome, platinum, platinum iridium, platinum chromium, platinum rhodium, or nickel titanium.

11. An endoluminal prosthesis as in claim 1 , wherein the circumferential rings are inclined at an angle relative to a longitudinal axis of the scaffold in the crimped configuration.

12. An endoluminal prosthesis as in claim 1 , wherein the scaffold is patterned from a tube, flat substrate, or a bent wire.

13. An endoluminal prosthesis as in claim 1 , wherein the scaffold further comprises at least one drug comprising an m-TOR inhibitor comprising sirolimus, novolimus, biolimus, everolimus, ridaforolimus, temsirolimus, or zotarolimus.

14. An endoluminal prosthesis as in claim 1 , wherein the scaffold further comprises a polymer coating, wherein the polymer coating comprises polylactide, poly-L-lactic acid, poly-DL-lactide, polylactide-co-glycolide, poly(lactic-co-glycolide), 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).

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

16. An endoluminal prosthesis as in claim 1 , wherein the separation regions comprise a pre-formed break or gap in the circumferential ring and is joined by, covered by, or embedded in the biodegradable polymer and/or adhesive which degrades in the physiologic environment.

17. An endoluminal prosthesis as in claim 1 , wherein the biodegradable polymer and/or adhesive comprises 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.

18. An endoluminal prosthesis as in claim 1 , wherein the polymer and/or adhesive provides a coating of at least one of the abluminal and luminal surfaces, wherein the polymer and/or adhesive coating is configured to immobilize the separation region and adjacent structural elements when the prosthesis is being expanded from a crimped configuration to an expanded configuration in a physiologic environment.

19. An endoluminal prosthesis as in claim 18 , wherein coated adjacent structural elements comprise one or more of struts, crowns, and/or circumferential rings.

20. An endoluminal prosthesis as in claim 18 , wherein said coating comprises a thickness of from 5 μm to 50 μm.

21. An endoluminal prosthesis as in claim 1 , wherein upon expansion the separation region allows some movement before separation of the separation region.

22. An endoluminal prosthesis as in claim 1 , wherein the gap before expansion in the separation region ranges from 3 μm to 100 μm.

23. An endoluminal prosthesis as in claim 1 , wherein said lock and key junctions are configured with the length of the male portion and corresponding female portion providing a surface area sufficient to provide adhesion or friction to prevent premature separation upon expansion of said scaffold.

24. An endoluminal prosthesis as in claim 1 , 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 and low recoil from said expanded configuration.

25. An endoluminal prosthesis as in claim 1 , wherein two portions of circumferential rings which remain joined by said axial link each have a separation region in a strut adjacent to said axial link.

26. An endoluminal prosthesis as in claim 1 , wherein said lock and key connection is configured such that the male portion remains contained within the corresponding female portion during expansion of said scaffold.

27. An endoluminal prosthesis, comprising:
a scaffold comprising structural elements and having a plurality of circumferential rings patterned from a non-degradable material, said scaffold being configured to expand from a crimped configuration to an initial expanded configuration;
wherein at least some of the circumferential rings comprise struts and crowns and have at least one separation region located in a strut, said at least one separation region is configured to form at least one discontinuity in said strut of said circumferential rings after expansion in a physiologic environment and at least portions of two of the circumferential rings remain axially joined after all discontinuities are for

Assignees

• Elixir Medical Corp

Inventors

• Sirhan Motasim
• Yan John
• Bhat Vinayak
• Paraschac Joseph
• Cryer Brett
• Serna Benjamyn S

Classifications

• A61F2002/91566

  connected trough to trough · CPC title

• A61F2/2442

  Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve · CPC title

• A61F2230/001

  Figure-8-shaped, e.g. hourglass-shaped · CPC title

• A61F2220/0033

  made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title