Uncaging stent

• US 10,076,431 B2
• Filed: 03/14/2018
• Issued: 09/18/2018
• 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:
  US15/921,508
• Publication Number:
  US 20180200091A1
• Time in Patent Office: 188 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 structural elements comprising a plurality of circumferential rings patterned from a first material comprising 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 comprising a break or a gap in said rings;

wherein said at least one separation region comprises a lock and key having a geometry configured to hold the separation region together during expansion, said lock containing said key at least in part, said lock and key both being located within the same circumferential ring, said lock and key being configured to be held together during expansion and move apart only after expansion in a physiologic environment.

2. An endoluminal prosthesis as in claim 1, wherein the separation region is located in a strut, crown, and/or circumferential connector.

3. An endoluminal prosthesis as in claim 1, wherein said lock and key 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.

5. An endoluminal prosthesis as in claim 1, wherein said separation region further comprises a second material comprising a degradable and/or non-degradable material comprising a polymer and/or adhesive providing a continuous circumferential path around the scaffold.

6. An endoluminal prosthesis as in claim 5, wherein said second material comprises a degradable polymeric polymer and/or adhesive.

7. An endoluminal prosthesis as in claim 1, wherein the circumferential rings are formed from bent wire forming a helical scaffold.

8. An endoluminal prosthesis as in claim 1 or claim 4, wherein a plurality of circumferential rings of said scaffold have at least one separation region each comprising a lock and key located within said rings.

9. An endoluminal prosthesis as in claim 1 or claim 4, wherein the separation region is located between two adjacent crowns or between two adjacent struts in said circumferential ring.

10. An endoluminal prosthesis as in claim 1 or claim 4, wherein said lock and key comprises a ball and socket, disc and cap, tongue in slot, interlocking combs, interlocking teeth, interlocking hooks, grooves or V'"'"'s or U'"'"'s with suitable opposing shapes, or wavy or undulating interlocking surfaces.

12. An endoluminal prosthesis as in claim 1 or claim 4, wherein said first material comprises a non-degradable metal or metal alloy.

13. An endoluminal prosthesis as in claim 12, 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.

15. An endoluminal prosthesis as in claim 1 or claim 4, wherein the scaffold further comprises at least one drug.

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

17. An endoluminal prosthesis as in claim 1 or claim 4, 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).

18. An endoluminal prosthesis as in claim 1 or claim 4, where said scaffold has a pattern comprising a serpentine, zigzag, or helical design.

22. An endoluminal prosthesis as in claim 1 or claim 4, 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.

28. An endoluminal prosthesis as in claim 1 or claim 10, wherein portions of said lock and key remain overlapped upon expansion in a physiologic environment.

4. An endoluminal prosthesis comprising:

a scaffold comprising structural elements comprising a plurality of circumferential rings patterned from a first material comprising 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 comprising a break or a gap in said rings;

wherein said at least one separation region comprises a lock and key, wherein said lock contains said key at least in part, and a second material configured to hold the lock and key together during expansion and providing a continuous circumferential path around the scaffold, said lock and key both being located within the same circumferential ring, wherein said separation region being configured to separate forming at least one discontinuity in said circumferential ring after expansion in a physiologic environment.

11. An endoluminal prosthesis ad in claim 4, wherein said at least one separation region is located in a strut, crown, and/or circumferential connector.

14. An endoluminal prosthesis as in claim 4, wherein the circumferential rings are formed from bent wire forming a helical scaffold.

19. An endoluminal prosthesis as in claim 4, wherein the separation region is joined by, covered by, or embedded in said second material.

20. An endoluminal prosthesis as in claim 4, wherein said second material comprises a biodegradable polymer and/or adhesive which degrades in the physiologic environment.

21. An endoluminal prosthesis as in claim 20, 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.

23. An endoluminal prosthesis as in claim 4, wherein said second material comprises a non-degradable material.

24. An endoluminal prosthesis as in claim 23, wherein said non-degradable material allows further expansion of the scaffold after recoil following an initial expansion.

25. An endoluminal prosthesis as in claim 23, wherein said non-degradable material comprises an elastic material wherein said elastic material remains intact after expansion of the scaffold in physiologic environment.

26. An endoluminal prosthesis as in claim 4, wherein said second material permits said key and lock to move in a radial, circumferential, and/or longitudinal direction after expansion in physiologic environment.

27. An endoluminal prosthesis as in claim 4, wherein said separation region is immobilized during expansion but configured to separate after expansion in the physiologic environment.

29. The endoluminal prosthesis as in claim 4, wherein at least some circumferential rings are axially joined and wherein portions of said circumferential rings remain axially joined after all discontinuities are formed.

30. An endoluminal prosthesis as in claim 4, wherein said lock and key 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.