Uncaging stent

• US 10,383,750 B1
• Filed: 03/18/2019
• Issued: 08/20/2019
• 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:
  US16/356,933
• Publication Number:
  US 20190231564A1
• Time in Patent Office: 155 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 helical scaffold having a multiplicity of adjacent helical turns comprising a plurality of struts joined by crowns, wherein at least some helical turns are axially connected to adjacent helical turns, said scaffold being expandable from a crimped configuration to a deployed configuration;

wherein at least some helical turns include at least one separation region configured to be held together during expansion and to separate after expansion of the scaffold to the deployed configuration in a physiologic environment.

2. An endoluminal prosthesis as in claim 1, wherein at least one separation region is formed in each turn of the helical scaffold.

3. An endoluminal prosthesis as in claim 1, wherein at least some of the separation regions are formed in crowns.

4. An endoluminal prosthesis as in claim 1, wherein at least some of the separation regions are formed in struts.

5. An endoluminal prosthesis as in claim 1, wherein all helical turns are axially connected to adjacent helical turns, and wherein said turns remain axially connected after expansion of the scaffold in a physiologic environment.

6. An endoluminal prosthesis as in claim 1, wherein all of the adjacent helical turns are axially connected and wherein at least some of said turns remain axially connected after expansion of the scaffold in a physiologic environment.

7. An endoluminal prosthesis as in claim 1, wherein at least some helical turns are axially connected to adjacent helical turns, and wherein said turns remain axially connected after expansion of the scaffold in a physiologic environment.

8. An endoluminal prosthesis as in claim 7, wherein the scaffold separates along separation lines which extend from a first end of the scaffold to a second end of the scaffold into two or more axially connected segments after expansion of the scaffold in a physiologic environment and separation of said separation regions.

9. An endoluminal prosthesis as in claim 1, wherein at least some of the adjacent helical turns are axially connected, wherein at least one axial connection comprises a separation region, said separation region being configured to separate after expansion of the scaffold in a physiologic environment.

10. An endoluminal prosthesis as in claim 9, wherein the separation regions are disposed between crowns on adjacent turns in the helical scaffold, between struts on adjacent turns in the helical scaffold, or between a crown on one turn and a strut on an adjacent turn in the helical scaffold.

11. An endoluminal prosthesis as in claim 9, wherein at least some of the separation regions between adjacent helical turns of the helical scaffold comprise a lock and key.

12. An endoluminal prosthesis as in claim 9, wherein at least some axial connections between adjacent helical turns remain intact after all separation regions have separated after expansion of the scaffold in a physiologic environment.

13. An endoluminal prosthesis as in claim 1, wherein the adjacent crowns on adjacent helical turns in the helical scaffold are out-of-phase so that the convex surfaces of at least some of the adjacent crowns are axially opposed and in contact or separated by a gap.

14. An endoluminal prosthesis as in claim 1, wherein the adjacent crowns on adjacent helical turns in the helical scaffold are in-phase so that a convex surface of one crown is connected to a concave side of an adjacent crown by an axial strut.

15. An endoluminal prosthesis as in claim 1, wherein the adjacent turns in the helical scaffold are axially connected, wherein said axial connections are formed by a link, by fusing together portions of said adjacent turns, by soldering together portions of said adjacent turns, or by adhesively connecting portions of said adjacent turns.

16. An endoluminal prosthesis as in claim 1, wherein the plurality of struts joined by crowns are formed in a serpentine or zig-zag pattern.

17. An endoluminal prosthesis as in claim 1, wherein at least some of the adjacent turns are axially connected in two or more locations, wherein at least one axial connection remains connected after expansion of the scaffold in a physiologic environment.

18. An endoluminal prosthesis as in claim 1, wherein the helical scaffold is formed from a tube, a bent wire, or a rolled sheet.

19. An endoluminal prosthesis as in claim 1, wherein at least some of the adjacent turns are axially connected, wherein each said axial connection comprises a separation region, said separation regions being configured to separate after expansion of the scaffold in a physiologic environment.

20. An endoluminal prosthesis as in claim 1, wherein at least some of the separation regions in the helical scaffold comprise a lock and key.

21. An endoluminal prosthesis as in claim 20, wherein the 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 or shapes.

22. An endoluminal prosthesis as in claim 1, wherein at least some of the separation regions in the helical scaffold comprise a male and female connection.

23. An endoluminal prosthesis as in claim 1, wherein said helical turns are configured to form a continuous circumferential path around said scaffold and wherein the said separation regions form one or more discontinuities in said helical turns after expansion of the scaffold in a physiologic environment, providing a discontinuous circumferential path in said at least some helical turns.

24. An endoluminal prosthesis as in claim 1, wherein the separation region comprises a coating, a sleeve, a solder, and/or adhesive which degrades after expansion of the scaffold in the physiologic environment.

25. An endoluminal prosthesis as in claim 1, wherein at least some of said separation regions comprise an elastic material disposed in, over, and/or adjacent to said separation region and wherein the elastic material remains intact after expansion in a physiologic environment.

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

27. An endoluminal prosthesis as in claim 1, wherein the helical 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).

28. An endoluminal prosthesis as in claim 1, wherein said scaffold is configured to expand from a crimped configuration to an initial expanded configuration and following an inward recoil from said initial configuration, further expand to a second expanded configuration.

29. An endoluminal prosthesis as in claim 1, wherein all crowns of at least some helical turns are free from separation regions.

30. An endoluminal prosthesis as in claim 1, wherein each helical turn has from one to five struts having a separation region.