Coated stent with geometry determinated functionality and method of making the same

• US 8,206,436 B2
• Filed: 11/11/2009
• Issued: 06/26/2012
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Mangiardi, Eric K., Reynolds, Jason M., Borg, Ulf R.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US12/616,455
• Publication Number:
  US 20100173066A1
• Time in Patent Office: 958 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.2, 623/1.44, 623/1.46, 427/2.24, 427/2.25, 427/2.27, 606191-198
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/08 Materials for coatings

Abstract

The present invention, in an exemplary embodiment, provides a stent, which combines many of the excellent characteristics of both silicone and metal stents while eliminating the undesirable ones. In particular, a principal objective in accordance with the present invention is to provide a family of stents where the relative hardness/softness of regions of the stent can differ from other regions of the stent to provide additional patient comfort and resistance to compression forces. Exemplary embodiments provide a stent that is coated in a manner that limits the amount of coating surface area that is in direct contact with the target lumen. In particular, a covered stent is provided that is coated internally such that the outer scaffolding surface of the stent is raised from the outer surface of the coating. To this end, cilia function is only partially limited and mucociliary clearance is not significantly affected. Moreover, the coating itself has anti-adherent properties such that bacteria, fungi or other microbials cannot colonize the cover in particular and the stent generally.

Claims

1. A method of coating a medical appliance comprising the steps of:

providing a medical appliance comprising a scaffolding of struts defining a substantially cylindrical member having a distal end and a proximal end and a lumen extending longitudinally therebetween, the scaffolding having an interior and an exterior surface along its longitudinal extension; and

applying a polymer to the medical appliance such that the exterior surface of the scaffolding is raised with respect to the polymer extending substantially over an area between the struts of the scaffolding.

2. The method of claim 1, further comprising annealing the polymer to the stent by applying heat to the polymer.

3. The method of claim 1, wherein applying comprises applying a polymer to the exterior surface of the scaffolding.

4. The method of claim 1, wherein applying comprises applying a polymer to the interior surface of the scaffolding.

5. The method of claim 1, wherein providing comprises providing a medical appliance further comprising an additional distal end wherein the medical appliance forms a substantially Y-shape.

6. The method of claim 1, further comprising spraying the medical appliance with a polymer prior to applying the polymer to the medical appliance.

7. The method of claim 1, further comprising providing a mold having an internal and an external diameter and inserting the medical appliance into the internal diameter of the mold.

8. The method of claim 7, further comprising applying a polymer to the interior surface of the medical appliance.

9. The method of claim 8, further comprising:

inserting a balloon within the internal diameter of the mold; and

expanding and heating the balloon to anneal the polymer to the medical appliance.

10. The method of claim 1, wherein the polymer is substantially hydrophobic.

11. The method of claim 10, wherein the polymer is hydroscopic.

12. The method of claim 1, wherein the polymer is substantially hydrophilic.

13. The method of claim 12, wherein the polymer is substantially hydroscopic.

14. The method of claim 1, wherein applying comprises applying the polymer to the medical appliance from the interior surface of the scaffolding outward.

15. The method of claim 1, wherein applying comprises applying the polymer to the medical appliance from the exterior surface of the scaffolding inward.

16. The method of claim 15, wherein applying comprises applying the polymer to the medical appliance such that the struts on the exterior surface of the scaffolding are raised with respect to the polymer applied between the struts of the medical appliance.

17. The method of claim 16, wherein applying comprises applying the polymer such that the polymer applied to the struts of the scaffolding is raised between 1 Å

to 10⁶ Å

with respect to the polymer applied between the struts of the scaffolding.

18. The method of claim 16, wherein applying comprises applying the polymer such that the relative extent to which the polymer applied to the exterior surface of the scaffolding is raised with respect to the polymer applied between the struts facilitates cilia function at the cite of implantation.