Helical hybrid stent

• US 10,363,152 B2
• Filed: 09/14/2016
• Issued: 07/30/2019
• Est. Priority Date: 06/27/2003
• Status: Expired due to Fees

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/265,216
• Publication Number:
  US 20170056217A1
• Time in Patent Office: 1,049 Days
• 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-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 helical main stent component having a tubular structure extending from a first end to a second end, the 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 side band and the second side band has an undulating pattern and forms a plurality of helical windings;

a polymer material interconnecting the plurality of the helical windings, wherein the polymer material extends in gaps between the plurality of helical windings; and

a drug included with at least one of the group consisting of the helical main stent component and the polymer material.

2. The stent of claim 1, wherein the first and second ends of the stent form a right cylinder.

3. The stent of claim 1, wherein the stent is balloon expandable.

4. The stent of claim 1, wherein the stent is self-expanding.

5. The stent of claim 1, further comprising a plurality of first cross struts connecting the first side band to the second side band.

6. The stent of claim 5, wherein the plurality of first cross struts have a first width and the first and second side bands have a second width.

7. The stent of claim 6, wherein the first width is equal to the second width.

8. The stent of claim 6, wherein the first width is larger than the second width.

9. The stent of claim 6, wherein the first width is smaller than the second width.

10. The stent of claim 5, wherein each of the first and second side bands forms a plurality of peaks and troughs.

11. The stent of claim 10, wherein said first cross-struts connect the first and second side bands at regular intervals.

12. The stent of claim 5, wherein a length of the first cross struts at a first end of the first side band shortens to taper the first end of the first side band toward the second side band, and wherein a length of the first cross struts at a first end of the second side band shortens to taper the first end of the second side band toward the first side band.

13. The stent of claim 1, wherein a first end of the first side band is tapered toward the second side band to form a plurality of differently sized cells and a first end of the second side band is tapered toward the first side band to form a plurality of differently sized cells.

14. The stent of claim 13, wherein the first and second side bands are connected directly to one another at the first and second ends.

15. The stent of claim 13, further comprising a first end band at the first end and a second end band at the second end.

16. The stent of claim 15, wherein each of said first and second end bands comprises an undulating pattern.

17. The stent of claim 15, wherein each of said first and second end bands extends at an angle to said first and second side bands.

18. The stent of claim 15, wherein said first and second end bands form a plurality of cells.

19. The stent of claim 15, further comprising a second cross strut connecting said first end band to said first side band and connecting said second end band to said second side band.

20. The stent of claim 19, wherein said second cross strut includes a loop.

21. The stent of claim 13, wherein undulations of the undulating pattern of the first and second side bands decrease at the first ends of the first and second side bands.

22. The stent of claim 1, wherein said first and second side bands form a plurality of cells.

23. The stent of claim 22 or 18, wherein said plurality of cells are one of triangular, square and hexagonal.

24. The stent of claim 1, wherein adjacent helical windings of the helical main stent component are not connected to one another by the helical main stent component.

25. The stent of claim 1, wherein the drug is selected from the group consisting of sirolimus, everolimus and analogs thereof.

26. The stent of claim 1, wherein the drug is embedded in said polymer material.

27. The stent of claim 26, wherein the drug is within interstices of said polymer material.

28. The stent of claim 1, wherein said stent is one of balloon expandable and self-expanding.

29. The stent of claim 1, wherein the polymer material is a mesh.

30. The stent of claim 1, wherein said helical main stent component is formed of one of the group consisting of:

stainless steel, cobalt chromium and Nitinol.

31. A stent comprising:

a helical main stent component having a tubular structure extending from a first end to a second end, the 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 side band and the second side band has an undulating pattern and forms a plurality of helical windings;

a polymer material interconnecting the plurality of the helical windings;

a drug included with at least one of the group consisting of the helical main stent component and the polymer material; and

a plurality of first cross struts connecting the first side band to the second side band, wherein a length of the plurality of first cross struts shortens toward the first and second ends.

32. A stent comprising:

a helical main stent component having a tubular structure extending from a first end to a second end, the 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 side band and the second side band has an undulating pattern and forms a plurality of helical windings;

a polymer material interconnecting at least the plurality of helical windings;

a drug included with at least one of the group consisting of the helical main stent component and the polymer material; and

a first end band at a first end of the first side band and a second end band at a second end of the second side band,

wherein the first end band comprises a hook.

33. A stent comprising:

a helical main stent component having a tubular structure extending from a first end to a second end, the 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 side band and the second side band has an undulating pattern and forms a plurality of helical windings;

a polymer material interconnecting the plurality of the helical windings; and

a drug included with at least one of the group consisting of the helical main stent component and the polymer material,

wherein each of the first and second side bands forms a plurality of peaks and troughs, and wherein troughs of the first side band are out of phase with troughs of the second side band, and wherein the peaks of the first side band are out of phase with peaks of the second side band.

34. A method of delivering a stent to a target vessel, comprising steps of:

introducing into a vessel said stent comprising a helical main stent component extending from a first end to a second end, the 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 side band and the second side band has an undulating pattern and forms a plurality of helical windings, a polymer material interconnecting at least a plurality of the main stent component helical windings wherein the polymer material extends in gaps between the plurality of helical windings, and a drug; and

delivering said stent to said target vessel.

35. The method of claim 34, further comprising a step of expanding said stent in the target vessel via an inflatable balloon.

36. The method of claim 34, further comprising a step of releasing said stent, wherein said stent is self-expanding.