Composite stent with regioselective material

• US 8,961,584 B2
• Filed: 12/18/2006
• Issued: 02/24/2015
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hossainy, Syed F. A., Padilla, Orlando, Mirzaee, Daryush, Tang, Fuh-Wei
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US11/641,381
• Publication Number:
  US 20070118212A1
• Time in Patent Office: 2,990 Days
• Field of Search: 623/1.15, 623/1.21, 623/1.12, 623/1.13, 623/1.14, 623/1.11, 623/1.2, 623/1.39, 623/1.44
• US Class Current: 623/1.15
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

A composite stent and a method for making the same are provided.

Claims

1. A stent consisting of a structural frame and two or more regioselective bands formed in situ on regions of the structural frame, each band being an unperforated hollow cylinder encircling the structural frame,

the regioselective bands being formed by drip-coating a material onto the regions of the structural frame as the stent rotates,

wherein the material is a substance selected from the group consisting of phosphoryl choline, ethylene vinyl alcohol (EVAL), polyanhydrides, polyesters, polyphosphazenes, polyhydroxybutyrate, polyhydroxyvalerate, polyurethanes, poly (butyl methacrylate), hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, block copolymers of polybutylene terephthalate and polyethylene glycol terephthalate, poly alpha-hydroxy acids, and combinations thereof, and optionally a therapeutic agent.

2. The stent of claim 1, wherein the therapeutic agent is present.

3. The stent of claim 1, wherein a substance from which the structural frame is made has a modulus of elasticity greater than a modulus of elasticity of the material forming the regioselective bands.

4. The stent of claim 1, wherein the substance of the material of the regioselective bands is selected from the group consisting of polyhydroxybutyrate, polyhydroxyvalerate, hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) PVP, PCL-co-PEG, PLA-co-PEG, poly alpha-hydroxy acids, polyanhydrides, and combinations thereof.

5. The stent of claim 1, wherein the substance of the material of the regioselective bands is selected from the group consisting of Ethylene vinyl alcohol (EVAL), polyphosphazenes, poly (butyl methacrylate), and combinations thereof.

6. The stent of claim 1, wherein at least one of the two or more bands is about 0.5 mm to about 3 mm in width.

7. A stent consisting of a structural frame and two or more regioselective bands formed in situ on regions of the structural frame, the regioselective bands being formed by dip-coating a material onto the regions of the structural frame, wherein each band is an unperforated hollow cylinder encircling the structural frame;

wherein the material is a substance selected from the group consisting of phosphoryl choline, ethylene vinyl alcohol (EVAL), polyanhydrides, polyesters, polyphosphazenes, polyhdroxbutyrate polyhydroxyvalerate, polyurethanes, poly (butyl) methacrylate), hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, block copolymers of polybutylene terephthalate and polyethylene glycol terephthalate, poly alpha-hydroxy acids, and combinations thereof, and optionally a therapeutic agent.

8. The stent of claim 7, wherein the therapeutic agent is present.

9. The stent of claim 7, wherein a substance from which the structural frame is made has a modulus of elasticity greater than a modulus of elasticity of the material forming the regioselective bands.

10. A composite stent consisting of:

an expandable structural frame made from a first material; and

two or more annular bands disposed on the expandable structural frame, the bands made from a second material, and each band being an unperforated hollow cylinder encircling the structural frame and in contact with a discrete region of the abluminal surface of the structural frame;

wherein the second material is a substance selected from the group consisting of phosphoryl choline, ethylene vinyl alcohol (EVAL), polyanhydrides, polyesters, polyphosphazenes, polyhydroxybutyrate, polyhydroxyvalerate, polyurethanes, poly (butyl methacrylate), hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, block copolymers of polybutylene terephthalate and polyethylene glycol terephthalate, poly alpha-hydroxy acids, and combinations thereof, and optionally a therapeutic agent.

11. The stent of claim 10, wherein a modulus of elasticity of the first material is higher than a modulus of elasticity of the second material.

12. The stent of claim 10, wherein at least one of the discrete regions of the ablumincal surface of the structural frame onto which the bands are disposed is substantially adjacent to an end of the frame.

13. The stent of claim 10, wherein at least one of the two or more annular bands is formed by drip-coating the second material onto the structural frame as the frame rotates.

14. The stent of claim 10, wherein the therapeutic agent is present.

15. The stent of claim 10, wherein at least one of the two or more annular bands is formed by dip-coating the second material onto the structural frame.

16. The stent of claim 10, wherein the substance of the second material of the annular bands is selected from the group consisting of polyhydroxybutyrate, polyhydroxyvalerate, hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, poly alpha-hydroxy acids, polyanhydrides, and combinations thereof.

17. The stent of claim 10, wherein the substance of the second material of the annular bands is selected from the group consisting of Ethylene vinyl alcohol (EVAL), polyphosphazenes, poly (butyl methacrylate), and combinations thereof.

18. The stent of claim 10, wherein at least one of the two or more bands is about 0.5 mm to about 3 mm in width.

19. A composite stent consisting of:

an expandable structural frame made from a first material having a first modulus of elasticity; and

two or more annular bands disposed on regions of the expandable structural frame, the bands made from a second material having a second modulus of elasticity, the second modulus of elasticity being lower than the first modulus of elasticity;

wherein each band is an unperforated hollow cylinder encircling the structural frame and in contact with a discrete region of the abluminal surface of the structural frame, the discrete region being one of the regions of the expandable structural frame;

wherein the second material is a therapeutic agent, and a substance selected from the group consisting of phosphoryl choline, ethylene vinyl alcohol (EVAL), polyanhydrides, polyesters, polyphosphazenes, polvhydroxybutyrate, polyhydroxyvalerate, polyurethanes, poly (butyl methacrylate), hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, block copolymers of polybutylene terephthalate and polyethylene glycol terephthalate, poly alpha-hydroxy acids, and combinations thereof.

20. The stent of claim 19, wherein the substance of the second material of the annular bands is selected from the group consisting of polyhydroxybutyrate, polyhydroxyvalerate, hyaluronic acid, water soluble chondroitin sulfate, poly (ethylene glycol) (PEG), poly (vinyl pyrrolidine) (PVP), PCL-co-PEG, PLA-co-PEG, poly alpha-hydroxy acids, polyanhydrides, and combinations thereof.

21. The stent of claim 19, wherein the substance of the second material of the annular bands is selected from the group consisting of Ethylene vinyl alcohol (EVAL), polyphosphazenes, poly (butyl methacrylate), and combinations thereof.

22. The stent of claim 19, wherein at least one of the two or more annular bands is about 0.5 mm to about 3 mm in width.