Coated medical devices and methods of making and using same

• US 9,320,592 B2
• Filed: 03/15/2013
• Issued: 04/26/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Wainwright, John, Mendelson, Todd, Haggstrom, Kurt, Molaei, Masoud, Schuman, Victoria, Sheu, Min-Shyan
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US13/844,577
• Publication Number:
  US 20140277400A1
• Time in Patent Office: 1,138 Days
• Field of Search: 623/1.53
• US Class Current: 1/1
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Coating methods and related devices are provided. Such devices can include stents. For example, the device can comprise a sidewall and a plurality of pores in the sidewall that are sized to inhibit flow of blood through the sidewall into an aneurysm to a degree sufficient to lead to thrombosis and healing of the aneurysm when the tubular member is positioned in a blood vessel and adjacent to the aneurysm. The device can also comprise an anti-thrombogenic coating distributed over at least a portion of the device such that the pores are substantially free of webs formed by the coating.

Claims

1. A medical device for treating an aneurysm, comprising:

a tubular member comprising a plurality of braided filaments, each of the filaments crossing another of the filaments at a respective crossing point, that form a sidewall and a plurality of pores in the sidewall that are sized to inhibit flow of blood through the sidewall into an aneurysm to a degree sufficient to lead to thrombosis and healing of the aneurysm when the tubular member is positioned in a blood vessel and adjacent to the aneurysm, the pores having an average pore size that is less than or equal to about 500 microns when the body is in the expanded state; and

an antithrombogenic material distributed over the tubular member wherein the pores are substantially free of webs formed by the material such that webs are present at fewer than 5% of the crossing points.

2. The medical device of claim 1, wherein the pores have an average pore size that is less than or equal to about 320 microns when the body is in the expanded state.

3. The medical device of claim 2, wherein the pores have an average pore size that is measured using an inscribed circle diameter.

4. The medical device of claim 1, wherein the distribution of the antithrombogenic material is substantially complete over the tubular member.

5. The medical device of claim 4, wherein the antithrombogenic material is generally uniform over the tubular member.

6. The medical device of claim 1, wherein the distribution of the antithrombogenic material is substantially complete over at least a circumferential section of the tubular member that is 5 mm or more in length.

7. The medical device of claim 6, wherein the antithrombogenic material comprises an antithrombogenic polymer.

8. The medical device of claim 7, wherein the antithrombogenic polymer comprises MPC.

9. The medical device of claim 1, wherein the tubular member comprises a heat-set metallic braid.

10. The medical device of claim 1, wherein the tubular member is self-expanding.

11. The medical device of claim 1, wherein the tubular member has an open proximal end, an open distal end, and forms a lumen extending from the proximal end to the distal end.

26. The medical device of claim 1, wherein the device is longitudinally stretched during a dipping process such that at a given crossing point, first and second filaments are substantially perpendicular relative to each other.

27. The medical device of claim 1, wherein the device is formed from a stent preform, and wherein the stent preform is dipped into an antithrombogenic solution while maintaining an end portion of the stent preform outside of the solution to facilitate drainage of antithrombogenic solution from the stent preform when the stent preform is removed from the antithrombogenic solution.

28. The medical device of claim 1, wherein the device is formed from a stent preform having first and second end portions, and wherein a mounting bracket is coupled to the first and second end portions of the preform and a backbone of the mounting bracket is radially offset from a longitudinal axis of the stent preform.

12. A medical device for treating an aneurysm, comprising:

a tubular body configured to be implanted in a blood vessel and comprising a plurality of braided filaments each crossing another of the filaments at a respective crossing point, the body being expandable to an expanded state for treatment of the aneurysm, the body having a first section for spanning the neck of the aneurysm and a plurality of pores located between the filaments, the pores in the first section having a first average pore size of less than about 500 microns when the body is in the expanded state;

the first section having a substantially complete distribution of antithrombogenic material over the filaments;

wherein the first section is substantially free of webs formed between the braided filaments by the antithrombogenic material such that webs are present at fewer than 5% of the crossing points.

13. The medical device of claim 12, wherein the first average pore size is less than or equal to about 320 microns.

14. The medical device of claim 12, wherein the first average pore size is measured using an inscribed circle diameter.

15. The medical device of claim 12, wherein the first average pore size is the average size of the pores in the first section without the antithrombogenic material.

16. The medical device of claim 12, wherein the first section comprises less than an entire length of the tube.

17. The medical device of claim 12, wherein the antithrombogenic material on the first section is generally uniform over the filaments.

18. The medical device of claim 12, wherein the antithrombogenic material comprises an antithrombogenic polymer.

19. The medical device of claim 18, wherein the antithrombogenic polymer comprises MPC.

20. The medical device of claim 12, wherein the tubular body comprises a heat-set metallic braid.

21. The medical device of claim 12, wherein the tubular body is self-expanding.

22. The medical device of claim 12, wherein the tubular body has an open proximal end, an open distal end, and forms a lumen extending from the proximal end to the distal end.

23. The medical device of claim 12, wherein the device is longitudinally stretched during a dipping process such that at a given crossing point, first and second filaments are substantially perpendicular relative to each other.

24. The medical device of claim 12, wherein the device is formed from a stent preform, and wherein the stent preform is dipped into an antithrombogenic solution while maintaining an end portion of the stent preform outside of the solution to facilitate drainage of antithrombogenic solution from the stent preform when the stent preform is removed from the antithrombogenic solution.

25. The medical device of claim 12, wherein the device is formed from a stent preform having first and second end portions, and wherein a mounting bracket is coupled to the first and second end portions of the preform and a backbone of the mounting bracket is radially offset from a longitudinal axis of the stent preform.