Stents and methods for preparing stents from wires having hydrogel coating layers thereon

• US 7,442,205 B2
• Filed: 07/13/2005
• Issued: 10/28/2008
• Est. Priority Date: 11/27/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Larik, Vincent, Verhoeven, Michel, Cahalan, Linda Lee, Cahalan, Patrick
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/181,495
• Publication Number:
  US 20050251250A1
• Time in Patent Office: 1,203 Days
• Field of Search: 623 111- 148, 424/423
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Radially expandable stents having hydrogel coating layers thereon, and methods of preparing such stents are disclosed. The methods include coating a wire with a solution that includes a solvent and a water soluble polymer in the solvent, evaporating the solvent to provide a polymeric coating on the wire, and crosslinking the polymeric coating to provide a hydrogel coating layer on the wire. The coated wire can be fabricated into stents, which preferably have substantially uniform coatings with low surface roughness. Preferably the coatings have hydrophilic properties and provide a biocompatible surface. The coatings may also provide for the delivery of biologically active agents into the body.

Claims

1. A radially expandable stent comprising a wire having a hydrogel coating layer thereon, wherein the stent is preparable by a method comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent and a water soluble polymer in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire; and

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent.

2. The stent of claim 1 wherein the solution is applied to the wire by a continuous coating method.

3. The stent of claim 2 wherein the continuous coating method comprises passing the wire through the solution at a substantially constant speed.

4. A method for making a radially expandable intravascular stent comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent and a water soluble polymer in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire; and

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent.

5. The method of claim 4 wherein the solution is applied to the wire by a continuous coating method.

6. The method of claim 5 wherein the continuous coating method comprises passing the wire through the solution at a substantially constant speed.

7. The method of claim 4 wherein the hydrogel coating layer has an average dry coating thickness of about 0.01 micrometer to about 25 micrometers.

8. The method of claim 4 wherein the thickness of the hydrogel coating layer has a relative standard deviation of no greater than about 10 percent.

9. A method for delivery of a biologically active agent to the interior of a body lumen comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent, a water soluble polymer in the solvent, and a biologically active agent dispersed in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire;

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent;

introducing the stent body transluminally into a selected portion of the body lumen; and

radially expanding the stent body into contact with the body lumen.

10. A method for delivery of a biologically active agent to the interior of a body lumen comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent and a water soluble polymer in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire;

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent;

applying a biologically active agent to the hydrogel coating layer;

introducing the stent body transluminally into a selected portion of the body lumen; and

radially expanding the stent body into contact with the body lumen.

11. A method of modifying cellular response in a body lumen to a disease, injury, or foreign body, comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent, a water soluble polymer in the solvent, and a biologically active agent dispersed in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire;

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent;

introducing the stent body transluminally into a selected portion of the body lumen;

radially expanding the stent body into contact with the body lumen; and

controllably releasing the biologically active agent into the body lumen.

12. A method of modifying cellular response in a body lumen to a disease, injury, or foreign body, comprising:

providing a metal wire;

applying to the wire a solution that includes a solvent and a water soluble polymer in the solvent;

evaporating the solvent to provide a polymeric coating on the wire;

crosslinking the polymeric coating to provide a hydrogel coating layer on the wire;

fabricating the coated wire into a cylindrical, radially expandable stent body, wherein the hydrogel coating layer is swollen with an aqueous fluid prior to fabricating the coated wire into a stent;

applying a biologically active agent to the hydrogel coating layer;

introducing the stent body transluminally into a selected portion of the body lumen;

radially expanding the stent body into contact with the body lumen; and

controllably releasing the biologically active agent into the body lumen.