Helical hybrid stent

• US 9,456,910 B2
• Filed: 05/09/2012
• Issued: 10/04/2016
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/467,800
• Publication Number:
  US 20120283817A1
• Time in Patent Office: 1,609 Days
• Field of Search: 623/1.22, 623/1.39, 623/1.42, 623/1.45, 623/1.46, 623/1.13, 623/1.16
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• 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 2/91 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 27/18 : Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: Y10T 29/49764 : with testing or indicating

Abstract

An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other to maintain the tubular shape of the helically coiled stent and prevent the polymer layer from sagging at any point between cycles of the coils.

Claims

1. A stent comprising:

a) a helical main stent component having a first side band and a second side band, wherein the first and second side bands are coextensive and wherein each of the first and second side bands has an undulating pattern having peaks and troughs and forms a plurality of helical windings, wherein the first and second side bands are connected by a cross strut, wherein each trough of the first side band is connected to each of the trough of the second side band; and

b) a polymer material interconnecting at least a plurality of the main stent component helical windings.

2. The stent according to claim 1 wherein the polymer material is a fiber mesh.

3. The stent according to claim 1 wherein the polymer material is a porous material.

4. The stent according to claim 1 wherein the polymer material is a durable material.

5. The stent according to claim 4 wherein the durable material is polyurethane.

6. The stent according to claim 1 wherein said side band is secured to a helically adjacent winding of said side band.

7. The stent according to claim 1, wherein the main stent component comprises a metal.

8. The stent according to claim 7, where the main stent component is formed from a tubular structure.

9. The stent according to claim 7, wherein the main stent component is cut from a flat sheet of metal.

10. The stent according to claim 7, wherein the main stent component comprises an amorphous metal alloy.

11. The stent according to claim 10, wherein said amorphous metal alloy comprises an element selected from the group consisting of silicon, boron, and phosphorous.

12. The stent according to claim 10, wherein said amorphous metal alloy is an iron-based alloy containing Fe, Cr, B, and P.

13. The stent according to claim 10 wherein the amorphous metal alloy contains silicon.

14. The stent according to claim 10 wherein the amorphous metal alloy comprises a Fe—

Cr—

B—

P alloy.

15. The stent according to claim 1 wherein at least one cross strut has a loop.

16. The stent according to claim 1, wherein the first side band tapers to narrow and connect to the second side band.

17. The stent according to claim 16 wherein said first side band is nestled in said helically adjacent second side band without direct connection between said first and second side bands.

18. The stent according to claim 1, wherein the polymer material secures the entire length of the helical main stent component.

19. The stent according to claim 1, wherein the polymer material secures the helical main stent component at an end.

20. The stent according to claim 1 further comprising a drug coating.

21. The stent according to claim 1, said helical main stent component further comprising:

an end band having an undulating pattern, said end band connected to said first side band and extending at an angle to said first side band.

22. The stent according to claim 1, wherein the polymer material has fenestrations.

23. The stent according to claim 1, wherein the polymer material is ePTFE.

24. The stent according to claim 1, wherein the polymer material provides longitudinal flexibility to the stent.

25. The stent according to claim 1, wherein the polymer material provides structural support for the stent.

26. The stent according to claim 1, wherein the polymer material interconnects adjacent windings of the main stent component in the longitudinal direction.

27. The stent according to claim 1, wherein the polymer material encases the main stent component therein.

28. The stent according to claim 1, wherein the polymer material is embedded within interstices of the main stent component.

29. The stent according to claim 1, wherein peaks of the first side band are aligned with troughs of the second side band.

30. A method of making the stent of claim 1 comprising the steps of:

a) helically winding the main stent component along a longitudinal axis to form a helically coiled structure; and

b) applying a polymer material.

31. The method of claim 30, wherein the main stent component further comprises a first end band having a first edge and a second edge, and a second side band having a first edge and a second edge, said method further comprising the steps of

c) bringing the first edge of the first end band with the second edge of the first end band into close proximity to form a cylinder;

and

d) bringing the first edge of the second end band with the second edge of the second end band into close proximity to form a cylinder.

32. The method of claim 30, further comprising the step of applying said polymer material to the main stent component by electrospinning.