Medical device having radio-opacification and barrier layers

• US 20020138136A1
• Filed: 03/23/2001
• Published: 09/26/2002
• Est. Priority Date: 03/23/2001
• Status: Abandoned Application

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Chandresekaran, Verivada Chandru, Kveen, Graig
• Application Number:
  US09/815,892
• Publication Number:
  US 20020138136A1
• Time in Patent Office: Days
• US Class Current: 623/1.34
• CPC Class Codes: A61L 31/121 having an inorganic matrix
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

A medical device such as a coronary stent is provided that can be visualized in-vivo while further aiding in the prevention of restenosis. The medical device comprises a core having a first layer disposed thereon. The first layer is made from a material that is radio-opaque so that the medical device may be visualized in-vivo. An outer layer is disposed onto and surrounds at least a portion of the first layer to provide a barrier layer between the radio-opaque inner layer and blood and/or tissue disposed within the patient'"'"'s vessel. The outer surface of the outer layer may include a textured surface of micro-pores, grooves, cross-hatched lines to receive a therapeutic agent. Drugs and treatments which utilize anti-thombogenic agents, and anti-proliferation agents may be readily deployed from the textured outer surface of the outer layer of the medical device.

Claims

1. A laminate structure for making a medical device comprising:

an core having an outer surface;

a first radio-opaque layer disposed on at least a portion of the outer surface of the core, the first radio-opaque layer having an outer surface; and

a second layer disposed on at least a portion of the outer surface of the first radio-opaque layer;

wherein the second layer isolates the first radio-opaque layer from blood within a patient'"'"'s vessel.

2. The laminate structure of claim 1, wherein the second layer covers a portion of the first radio-opaque layer and a portion of the core.

3. The laminate structure of claim 1, wherein the first radio-opaque layer surrounds the core.

4. The laminate structure of claim 3, wherein the second layer surrounds the first radio-opaque layer.

5. The laminate structure of claim 1, wherein the outer surface of the second layer is capable of receiving a drug compound.

6. The laminate structure of claim 1, wherein the second layer is made from an oxide of a metal selected from the group consisting of Ti, Cr, Ta, and Al.

7. The laminate structure of claim 1, wherein the second layer is made from a nitride of a metal selected from the group consisting essentially of Ti, Cr, Ta, and Al.

8. The laminate structure of claim 1, wherein the second layer is made from a carbide of a metal selected from the group consisting essentially of Ti, Cr, Ta, and V.

9. In a medical device implantable within a patient'"'"'s vessel, the medical device including a core having an outer surface, the outer surface having a layered structure thereon, the layered structure comprising:

a radio-opaque inner layer disposed onto the outer surface of the core, and

an outer bio-compatible layer surrounding the radio-opaque inner layer;

wherein the outer layer isolates the radio-opaque inner layer from blood or tissue within the patient'"'"'s vessel.

10. A medical device comprising:

a core having an outer surface;

a radio-opaque inner layer disposed onto at least a portion of the outer surface of the core, and

a bio-compatible outer layer, the outer layer covering at least a portion of the radio-opaque inner layer to reduce contact between the radio-opaque material and blood within a patient'"'"'s vessel.

11. The medical device of claim 10, wherein the radio-opaque inner layer surrounds the core.

12. The medical device of claim 11, wherein the outer layer surrounds the radio-opaque inner layer to inhibit the radio-opaque layer from coming into contact with blood and tissue from with a patient'"'"'s vessel.

13. The medical device of claim 10, wherein the medical device is a coronary stent.

14. The medical device of claim 10, wherein the outer layer is made from an oxide of a metal selected from the group consisting of Ti, Cr, Ta, and Al.

15. The medical device of claim 10, wherein the outer layer is made from a nitride of a metal selected from the group consisting essentially of Ti, Cr, Ta, and Al.

16. The medical device of claim 10, wherein the outer layer is made from a carbide of a metal selected from the group consisting essentially of Ti, Cr, Ta, and V.

19. The device of claim 18, wherein the visibility increasing means comprises a radio-opaque layer disposed on at least a portion of the outer surface of the core.

20. The device of claim 19, wherein the means for establishing a barrier on the outer surface of the device comprises an outer layer disposed on at least a portion of the outer surface of the radio-opaque layer to form a barrier layer between the radio-opaque layer and the patient'"'"'s blood.

21. The device of claim 20, wherein the outer layer is made from an oxide of a metal selected from the group consisting of Ti, Cr, Ta, and Al.

22. The device of claim 20, wherein the outer layer is made from a nitride of a metal selected from the group consisting essentially of Ti, Cr, Ta, and Al.

23. The device of claim 20, wherein the outer layer is made from a carbide of a metal selected from the group consisting essentially of Ti, Cr, Ta, and V.

17. A method of treating an occluded vessel with a stent, comprising the acts of:

routing a delivery catheter having the stent mounted or restrained thereon to a position proximal to the diseased section of the vessel wherein the stent is of the type that includes;

a core having an outer surface, a radio-opaque inner layer disposed onto at least a portion of the outer surface of the core, and a bio-compatible outer layer, the outer layer covering at least a portion of the radio-opaque inner layer to reduce contact between the radio-opaque material and blood or tissue within the diseased vessel;

deploying the stent from the delivery catheter;

expanding the stent into abutment against the interior lining of the diseased vessel so as to provide a support mechanism to prevent closure of the vessel.

18. A device used in-vivo comprising:

a core;

means for increasing the visibility of the core to in-vivo viewing methods; and

means for establishing a barrier on the outer surface of the device so that the visibility increasing means is isolated from a patient'"'"'s blood.