Coated medical device

• US 8,974,522 B2
• Filed: 03/25/2011
• Issued: 03/10/2015
• Est. Priority Date: 10/31/2000
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Bates, Brian L., Ragheb, Anthony O., Stewart, Joseph M. IV, Bourdeau, William J., Choules, Brian D., Purdy, James D., Fearnot, Neal E.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/072,332
• Publication Number:
  US 20110264197A1
• Time in Patent Office: 1,446 Days
• Field of Search: 623 142- 143
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0025 differing in roughness
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0081 Prosthesis for animals
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• 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 2300/606 Coatings
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 : Materials at least partially X-ray or laser opaque
• 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 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/1031 : Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Claims

1. A coated medical device, comprising:

a vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of a vessel when the stent is implanted in the vessel, wherein said first surface has a first surface roughness;

a coating adhered directly to said first surface of said base material, the coating have a first coating side adhered directly to said first surface and a second coating side opposite said first coating side and positioned to contact the wall of the vessel when in the stent is implanted in the vessel, with said second coating side having a second surface roughness that is greater than said first surface roughness, and said coating comprising paclitaxel; and

said coating being the only coating on the vascular stent.

2. The coated medical device of claim 1, wherein said first surface has a mean surface roughness of about 10 μ

in and a surface roughness range between about 1 μ

in to about 100 μ

in.

3. The coated medical device of claim 1, wherein said coating comprises a mixture including paclitaxel in combination with an antiplatelet agent.

4. The coated medical device of claim 1, wherein said coating comprises a mixture including paclitaxel in combination with a vasodilation inducing agent.

5. The coated medical device of claim 1, wherein said coating comprises a mixture including paclitaxel in combination with a phosphodiesterase inhibiting agent.

6. The coated medical device of claim 1, wherein said coating consists essentially of paclitaxel.

7. The coated medical device of claim 1, wherein said coating consists of paclitaxel.

8. The coated medical device of claim 1, wherein said coating includes a coating material or layering material in combination with the paclitaxel.

9. The coated medical device of claim 1, wherein said first surface has been roughened by abrading or etching.

10. A coated medical device, comprising:

a vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of a vessel when the stent is implanted in the vessel, wherein said first surface has been roughened by abrading or etching to form a roughened surface, with said first surface having a first surface roughness;

a coating adhered to said first surface of said base material, said coating having a first coating side adhered directly to said first surface and a second coating side opposite said first coating side and positioned to contact the wall of the vessel when in the stent is implanted in the vessel, with the second coating side having a second surface roughness that is greater than said first surface roughness, said coating comprising a mixture of bioactive agents, and the mixture comprising paclitaxel in combination with an antiplatelet agent, a vasodilation inducing agent, or a phosphodiesterase inhibiting agent; and

said vascular stent being free from any layer atop said coating, free from any containment layer containing said mixture of bioactive agents, and free from any time release layer containing said mixture of bioactive agents.

11. The coated medical device of claim 10, wherein said first surface has a mean surface roughness of about 10 μ

in and a surface roughness range between about 1 μ

in to about 100 μ

in.

12. A coated medical device, comprising:

a vascular stent for implantation in a vessel, the vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of the vessel when the vascular stent is implanted, wherein said first surface has a first surface roughness, and a second surface facing oppositely to said first surface;

a coating adhered to the first surface of the base material, said coating having a first coating side adhered directly to said first surface and a second coating side opposite the first coating side and positioned to contact the wall of the vessel when the stent is implanted in the vessel, with the second coating side having a surface roughness greater than said first surface roughness, and said coating comprising paclitaxel;

said vascular stent being free from any layer atop said coating; and

wherein said first surface has a mean surface roughness of about 10 μ

in and a surface roughness range between about 1 μ

in to about 100 μ

in.

13. The coated medical device of claim 12, wherein the vascular stent is comprised of metal, wherein said first surface is a metal surface, and wherein said first coating side is adhered directly to the metal surface.

14. The coated medical device of claim 12, wherein said coating includes a coating material or layering material in combination with the paclitaxel.

15. The coated medical device of claim 12, wherein said first surface has been roughened by abrading or etching.

16. A coated medical device, comprising:

a vascular stent for implantation in a vessel, the vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of the vessel when the vascular stent is implanted, wherein said first surface has a first surface roughness, and a second surface facing oppositely to said first surface;

a coating adhered to the first surface of the base material, said coating having a first coating side adhered directly to said first surface and a second coating side opposite the first coating side and positioned to contact the wall of the vessel when the stent is implanted in the vessel, with the second coating side having a surface roughness greater than said first surface roughness, and said coating consisting essentially of paclitaxel; and

said vascular stent being free from any layer atop said coating.

17. A coated medical device, comprising:

a vascular stent for implantation in a vessel, the vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of the vessel when the vascular stent is implanted, wherein said first surface has a first surface roughness, and a second surface facing oppositely to said first surface;

a coating adhered to the first surface of the base material, said coating having a first coating side adhered directly to said first surface and a second coating side opposite the first coating side and positioned to contact the wall of the vessel when the stent is implanted in the vessel, with the second coating side having a surface roughness greater than said first surface roughness, and said coating consisting of paclitaxel; and

said vascular stent being free from any layer atop said coating.

18. A coated medical device, comprising:

a vascular stent for implantation in a vessel, the vascular stent comprised of a non-porous base material, said base material having a first surface that faces outwardly toward a wall of the vessel when the vascular stent is implanted, wherein said first surface has a first surface roughness, and a second surface facing oppositely to said first surface;

a coating adhered to the first surface of the base material, said coating having a first coating side adhered directly to said first surface and a second coating side opposite the first coating side and positioned to contact the wall of the vessel when the stent is implanted in the vessel, with the second coating side having a surface roughness greater than said first surface roughness, and said coating comprising paclitaxel;

said vascular stent being free from any layer atop said coating; and

wherein said vascular stent is free from any containment layer containing the paclitaxel, and free from any time-release layer containing the paclitaxel.