Implantable Medical Device with Particulate Coating

• US 20080033522A1
• Filed: 07/24/2007
• Published: 02/07/2008
• Est. Priority Date: 08/03/2006
• Status: Abandoned Application

• Current Assignee: MED Institute, Inc. (Cook Group Incorporated)
• Original Assignee: MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Ragheb, Anthony O., Grewe, David D., Voorhees, William D.
• Application Number:
  US11/782,037
• Publication Number:
  US 20080033522A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61L 31/082 Inorganic materials

Abstract

Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with a vessel-engaging region on at least a portion of the medical device. The vessel-engaging region may be a particulate coating configured and adapted to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft material, to the frame. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Claims

1. A method of securing a medical device within a body vessel, the method comprising:

(a) inserting a wire guide into a body vessel and advancing the wire guide to a point of treatment;

(b) inserting a medical device delivery system into the body vessel along the wire guide, the medical device delivery system including a delivery catheter and a radially-expandable medical device releasably contacting a distal portion of the delivery catheter, the medical device being in a radially compressed configuration and having a vessel-engaging surface consisting of a plurality of inorganic particles adhered to a surface of the medical device to form the vessel-engaging surface with an average surface roughness of between about 10 nm and 100 micrometers and having a hardness of about 30-80 HRD on the “

D”

scale measured by the ASTM D2240 type D standard;

(c) advancing the distal portion of the delivery catheter with the medical device within the body vessel to the point of treatment within the body vessel;

(d) radially expanding the medical device at the point of treatment to directly contact the vessel-engaging surface with an inner wall of the body vessel;

(e) engaging the vessel-engaging surface with inner wall of the body vessel by embedding at least a portion of the vessel-engaging surface within the inner wall of the body vessel to secure the medical device within the body vessel;

(f) releasing the delivery catheter from the medical device; and

(g) removing the delivery catheter and the wire guide from the body vessel while retaining the medical device at the point of treatment within the body vessel.

2. The method of claim 1 where the inorganic particles are adhered to the surface of the medical device without a carrier polymer.

3. The method of claim 1, where the vessel-engaging surface is formed by adhering the inorganic particles to the surface of the medical device by sputter deposition or ion beam implantation.

4. The method of claim 1, where the vessel-engaging surface is formed by adhering the inorganic particles to the surface with a cyanoacrylate polymer adhesive.

5. A method of securing a medical device having a vessel-engaging surface within a body vessel, the method comprising:

(a) inserting a radially-expandable medical device into a body vessel in a radially compressed configuration, the medical device including a vessel-engaging surface having a plurality of inorganic particles adhered to the medical device with an average surface roughness of between about 10 nm and 100 micrometers and having a hardness of between about 30-100 HRD on the “

D”

scale measured by the ASTM D2240 type D standard;

(b) advancing the medical device within the body vessel to a point of treatment within the body vessel;

(c) radially expanding the medical device to directly contact the vessel-engaging surface with an inner wall of the body vessel; and

(d) engaging the vessel-engaging surface with inner wall of the body vessel by embedding at least a portion of the vessel-engaging surface within the inner wall of the body vessel to secure the medical device within the body vessel.

6. The method of claim 5, where the vessel-engaging surface is formed by a plurality of inorganic particles and is free of a carrier.

7. The method of claim 5, where the medical device is a stent or stent graft having a substantially tubular shape when radially expanded from the radially compressed configuration.

8. The method of claim 7, where the medical device includes a first vessel-engaging region on the exterior surface of the tubular shape.

9. The method of claim 5, where the vessel-engaging region includes an average of about 7.75 to about 12.4 particles per square centimeter.

10. The method of claim 5, where the inorganic particles comprise a material selected from the group consisting of:

silicon carbide, alumina zirconia, talc, mica, silica, a glass, hydroxyapatite, silicone dioxide, iron oxide, emery, calcium phosphates, calcium carbonates, calcium sulfate, aluminum oxide, stainless steel, cobalt chromium, nickel titanium and tantalum.

11. The method of claim 5, where the inorganic particles further comprise a biodegradable material.

12. The method of claim 5, where the inorganic particles have an acicular shape and a portion that is hooked or barbed.

13. The method of claim 5, where the vessel-engaging region further includes a material selected from the group consisting of:

hyaluronic acid, poly(lactide), poly(lactide-co-glycolide), poly(glycolide), poly(hydroxybutyrate), poly(orthoesters), polyesters and poly(hydroxyvaleric acid).

14. The method of claim 5, where the medical device comprises a radially expandable frame moveable from a radially compressed configuration to a radially expanded configuration.

15. The method of claim 5, where the medical device is configured as a vascular stent comprising a proximal hoop member and a first vessel-engaging region on the proximal hoop member, the proximal hoop member joined to a distal hoop member with a second vessel-engaging region on the distal hoop member.

16. The method of claim 5, where the medical device is configured as a stent graft comprising a support frame attached to a tubular graft material having an exterior surface and an interior surface, the vessel-engaging region being disposed on the exterior surface of the graft material.

17. A medical device comprising a radially expandable frame adapted for implantation in a body vessel, the frame defining a substantially tubular lumen and having an exterior surface, wherein at least a portion of the exterior surface comprises a vessel-engaging surface formed by a plurality of particles attached to the exterior surface to form the vessel-engaging surface with an average roughness of about 10 nm and 100 μ

m having a hardness of between about 30-100 HRD on the “

D”

scale measured by the ASTM D2240 type D standard, and the plurality of particles consisting of one or more materials selected from the group consisting of;

metals, inorganic oxides and cellulose-containing biomaterials.

18. The medical device of claim 17, wherein the vessel-engaging surface has a maximum roughness of less than about 25 micrometers and a concentration of inorganic particles of at least 10,000 per square centimeter of the vessel-engaging surface.

19. The medical device of claim 18, wherein the particles consist of aluminum oxide.

20. The medical device of claim 17, where

(a) the medical device is configured as a tubular metallic vascular stent or stent graft with the vessel-engaging surface formed on a portion of the exterior surface of the medical device;

(b) the vessel-engaging surface consists of a polymer carrier in contact with the particles and the exterior surface of the medical device, the vessel-engaging surface having an average roughness of between about 1 and 100 micrometers and a concentration of particles of 7.75 to 15.5 particles per square centimeter of the vessel-engaging surface; and

(c) the particles consist of a cellulose-containing biopolymer having a hardness of about 30-100 HRD on the “

D”

scale measured by the ASTM D2240 type D standard.