Helical hybrid stent

• US 8,382,821 B2
• Filed: 04/22/2009
• Issued: 02/26/2013
• Est. Priority Date: 12/03/1998
• Status: Active Grant

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/428,347
• Publication Number:
  US 20090234433A1
• Time in Patent Office: 1,406 Days
• Field of Search: 623/1.15, 623/1.22
• US Class Current: 623/1.22
• 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. The nestling of the undulation of adjacent helical coils contributes to maintaining the tubular shape of the helically coiled stent. In addition, the nestling of helical coils may prevent the polymer layer from sagging at any point between cycles of the helical coils.

Claims

1. A stent comprising a helical main stent component, said component comprising:

a) a first side band having an undulating pattern, said first side band having a first length;

b) a second side band formed of an undulating pattern, said second side band having a first length;

c) a first end band having an undulating pattern, said first end band connected to said first side band and extending at an angle to said first side band, said first end band having a second length shorter than said first length,

d) a second end band formed of an undulating pattern, said second end band connected to said second side band and extending at an angle to said second side band, said second end band having said second length;

e) a third end band formed of an undulating pattern, said third end band arranged generally in the same direction as said first end band and periodically joined to said first end, band, said third end band having a third length shorter than said second length;

e) a fourth end band formed of an undulating pattern, said fourth end band arranged generally in the same direction as said second end band and periodically joined to said second end band, said fourth end band having said third length;

g) first cross-struts arranged generally between said first and second side bands,

h) second cross-struts arranged generally between said first end band and said first side band, and between said second end band and said second side band.

2. The stent according to claim 1 further comprising a polymer material.

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

4. The stent according to claim 2 wherein the polymer material is a porous material.

5. The stent according to claim 2, wherein the polymer material secures the entire length of the coiled main stent component.

6. The stent according to claim 2, wherein the polymer material secures the helical main stent component at an end.

7. The stent according to claim 2 wherein the polymer material is a durable material.

8. The stent according to claim 7 wherein the durable material is polyurethane.

9. The stent according to claim 1 wherein at least one side band is fixed to a helically adjacent coiled side band.

10. The stent of claim 1, wherein the main stent component comprises a metal.

11. The stent according to claim 10, where the main stent component is an etched tubular structure.

12. The stent according to claim 10, wherein the main stent component is a helical structure cut from a flat sheet.

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

14. The stent according to claim 13, wherein said amorphous metal alloy comprises an element selected from the group consisting of silicon, boron, and phosphorous.

15. The stent according to claim 13, wherein said amorphous metal alloy is an iron-based alloy containing Fe, Cr, B, and P.

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

17. The stent according to claim 13 wherein the amorphous metal alloy comprises a Fe—

Cr—

B—

P alloy.

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

19. The stent according to claim 18 wherein at least one second cross strut has a loop.

20. The stent according to claim 1, wherein the first side band is tapered at an end.

21. The stent according to claim 1 wherein said first side band is nestled in a helically adjacent second side band.

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