Luminal prostheses and methods for coating thereof

Patent metadata

Field	Value
Publication number	US-9937280-B2
Application number	US-42659809-A
Country	US
Kind code	B2
Filing date	Apr 20, 2009
Priority date	Oct 20, 2006
Publication date	Apr 10, 2018
Grant date	Apr 10, 2018

Abstract

Luminal prostheses comprise scaffolds having coatings adhered to at least a portion of their outer surfaces. The surfaces are modified to enhance binding of the coatings. For example, the surfaces may be microblasted, laser treated, chemically etched, exposed to plasma, or exposed to a corona discharge, allowing a polymeric coating to adhere to the scaffold more tightly than in the absence of the surface modification. The coatings can be used to deliver therapeutic or other agents dispersed therein.

First claim

What is claimed is:

1. A luminal prostheses comprising:
a scaffold adapted to be radially deformed in a body lumen, said scaffold having an outer surface region and undergoing strain when the scaffold is deformed, wherein the surface region is modified to produce features having an average density in the range from 0.001 to 0.1 features per um 2 ;
a coating deposited over the surface region, wherein the coating interact with the modified surface region to have an adherence greater than adherence in the absence of the surface modification; and
a therapeutic agent dispersed or distributed in the coating.

2. A luminal prosthesis as in claim 1 , wherein the coating softens in a physiologic environment.

3. A luminal prosthesis as in claim 2 , wherein the coating comprises a polymer.

4. A luminal prosthesis as in claim 3 , wherein the polymer has a glass transition temperature below physiologic temperature.

5. A luminal prosthesis as in claim 3 , wherein the polymer is selected from the group consisting of poly(alkyl methacrylate) polymers, poly butyl methacrylate, poly (alkylene carbonate) polymers, polyethylene carbonate, copolymers of poly (lactide) and trimethylene carbonate, copolymers of poly (lactide) and poly (glycolide), and copolymers of poly (lactide) and polyethylene glycol.

6. A luminal prosthesis as in claim 1 , wherein the features have a size in the range from 50 nm to 50 μm.

7. A luminal prosthesis as in claim 3 , wherein the polymer is non-erodible in a luminal environment and has a molecular weight greater than 500 KDa.

8. A luminal prosthesis as in claim 7 , wherein the polymer comprises poly-n-butylmethacrylate or another poly(alkyl methacrylate).

9. A luminal prosthesis as in claim 3 , wherein the polymer is erodible in a luminal environment and has a molecular weight above 50 KDa.

10. A luminal prosthesis as in claim 9 , wherein the polymer is selected from the group consisting of poly (alkylene carbonate) polymers, polyethylene carbonate, copolymers of poly (lactide) and trimethylene carbonate, copolymers of poly (lactide) and poly (glycolide), and copolymers of poly (lactide) and polyethylene glycols.

11. A luminal prosthesis as in claim 1 , wherein the therapeutic agent has a concentration of at least 50% by weight based on the total weight of the coating and therapeutic agent.

12. A luminal prosthesis as in claim 1 , wherein the therapeutic agent is selected from the group consisting of immunomodulators, anti-cancer agents, anti-proliferative agents, anti-inflammatory agents, antithrombotic agents, antiplatelet agents, antifungal agents, antidiabetic agents, antihyperlipidemia agents, antiangiogenic agents, angiogenic agents, antihypertensive agents, and combinations thereof.

13. A luminal prosthesis as in claim 1 , wherein the scaffold is configured to have a strain of less than 50% of a peak strain in a deformed region when the scaffold undergoes radial deformation.

14. A catheter assembly comprising:
a catheter having an expandable polymeric balloon; and
a luminal prosthesis carried by the expandable balloon, wherein the luminal prosthesis comprises:
a scaffold adapted to be radially deformed in a body lumen, said scaffold having an outer surface region and undergoing strain when the scaffold is deformed, wherein the surface region is modified to produce features having an average density in the range from 0.001 to 0.1 features per um 2 ;
a coating deposited over the surface region, wherein the coating interact with the modified surface region to have an adherence greater than adherence in the absence of the surface modification; and
a therapeutic agent dispersed or distributed in the coating.

15. A catheter assembly as in claim 14 , wherein the coating softens in a physiologic environment.

16. A catheter assembly as in claim 15 , wherein the coating comprises a polymer.

17. A catheter assembly as in claim 16 , wherein the polymer has a glass transition temperature below physiologic temperature.

18. A catheter assembly as in claim 16 , wherein the expandable balloon is composed of a polymer having a glass transition temperature below that of the coating polymer.

19. A catheter assembly as in claim 16 , wherein the polymer is selected from the group consisting of poly(alkyl methacrylate) polymers, poly butyl methacrylate, poly (alkylene carbonate) polymers, polyethylene carbonate, copolymers of poly (lactide) and trimethylene carbonate, copolymers of poly (lactide) and poly (glycolide), and copolymers of poly (lactide) and polyethylene glycol.

20. A catheter assembly as in claim 14 , wherein the features have a size in the range from 50 nm to 50 μm.

21. A catheter assembly as in claim 16 , wherein the polymer is non-erodible in a luminal environment and has a molecular weight greater than 500 KDa.

22. A catheter assembly as in claim 21 , wherein the polymer comprises poly-n-butylmethacrylate or another poly(alkyl methacrylate).

23. A catheter assembly as in claim 16 , wherein the polymer is erodible in a luminal environment and has a molecular weight above 50 KDa.

24. A catheter assembly as in claim 23 , wherein the polymer is selected from the group consisting of poly (alkylene carbonate) polymers, polyethylene carbonate, copolymers of poly (lactide) and trimethylene carbonate, copolymers of poly (lactide) and poly (glycolide), and copolymers of poly (lactide) and polyethylene glycols.

25. A catheter assembly as in claim 14 , wherein the therapeutic agent has a concentration of at least 50% by weight based on the total weight of the coating and therapeutic agent.

26. A catheter assembly as in claim 14 , wherein the therapeutic agent is selected from the group consisting of immunomodulators, anti-cancer agents, anti-proliferative agents, anti-inflammatory agents, antithrombotic agents, antiplatelet agents, antifungal agents, antidiabetic agents, antihyperlipidemia agents, antiangiogenic agents, angiogenic agents, antihypertensive agents, and combinations thereof.

27. A catheter assembly as in claim 14 , wherein the scaffold is configured to have a strain of less than 50% of a peak strain in a deformed region when the scaffold undergoes radial deformation.

28. A method for coating a luminal scaffold, said method comprising:
modifying at least a portion of a surface region of the scaffold to produce surface features in the region to increase adherence of a coating, wherein the surface features have a density in the range from 0.001 to 0.1 features per um 2 ; and
coating a material over the modified surface region, wherein the material includes a therapeutic agent in the coating, and wherein the material interacts with the modified surface region to have an adherence greater than adherence in the absence of the surface modification.

29. A method as in claim 28 , wherein the material softens in a physiologic environment.

30. A method as in claim 29 , wherein the material comprises a polymer.

31. A method as in claim 30 , wherein the polymer has a glass transition temperature below physiologic temperature.

32. A method as in claim 30 , wherein the polymer is selected from the group consisting of poly(alkyl methacrylate) polymers, poly butyl methacrylate, poly (alkylene carbonate) polymers, polyethylene carbonate, copolymers of poly (lactide) and trimethylene

Assignees

• Yan John
• Huang Howard
• Bhat Vinayak D
• Elixir Medical Corp

Inventors

• Yan John
• Huang Howard
• Bhat Vinayak D

Classifications

• A61L2300/606

  Coatings · CPC title

• A61L29/085

  Macromolecular materials · CPC title

• A61L27/34 Primary

  Macromolecular materials · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61F2/915

  with bands having a meander structure, adjacent bands being connected to each other · CPC title