MEDICAL DEVICES HAVING MULTIPLE LAYERS

• US 20100280452A1
• Filed: 07/13/2010
• Published: 11/04/2010
• Est. Priority Date: 05/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weber, Jan, Chen, John Jianhua
• Granted Patent: US 8,293,262 B2
• Time in Patent Office: Days
• US Class Current: 604/103.01
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/624 Nanocapsules
• 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: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

Described herein are medical devices which are configured for implantation or insertion into a subject, preferably a mammalian subject. The medical devices contain one or more multilayer regions, which contain: (a) one or more (typically a plurality of) charged nanoparticle layers and (b) one or more (typically a plurality of) charged polyelectroyte layers. Such multilayers have a number of desirable attributes, including high strength, non-compliance, and flexibility. Also described herein are methods of making such devices.

Claims

1. An expandable medical balloon, the expandable medical balloon comprising:

(a) a polymer layer, the polymer layer defines a balloon wall comprising an inner surface and an outer surface, the inner surface defining a lumen;

(b) a multilayer region comprising;

(i) a charged nanoparticle layer; and

(ii) a plurality of charged polyelectroyte layers comprising charged polyelectrolyte species; and

(c) a therapeutic agent disposed on or within the multilayer region.

2. The expandable medical balloon of claim 1 wherein said charged nanoparticle layer comprises at least one member selected from the group consisting of carbon nanotubes, carbon nanofibers, fullerenes, ceramic nanotubes, ceramic nanofibers, phyllosilicates, monomeric silicates and dendrimers.

3. The expandable medical balloon of claim 1 wherein a surface charge is provided on the polymer layer by exposing the polymer layer to a charged amphiphilic substance.

4. The expandable medical balloon of claim 3 wherein the amphiphilic substance comprises at least one of poly(styrene sulfonate) or polyethylene imine.

5. The expandable medical balloon of claim 4 wherein the amphiphilic substance is polyethylene imine.

6. The expandable medical balloon of claim 1 wherein a surface charge is provided on the polymer layer by exposing the polymer layer to a cationic or anionic substance.

7. The expandable medical balloon of claim 1 wherein the plurality of charged polyelectrolyte layers comprises polyethylene imine or polyacrylic acid.

8. The expandable medical balloon of claim 1 wherein said polymer layer comprises poly(ether-block-amide) or polyurethane.

9. The expandable medical balloon of claim 8 wherein said polymer layer comprises poly(ether-block-amide).

10. The expandable medical balloon of claim 8 wherein said polymer layer comprises polyurethane.

11. The expandable medical balloon of claim 8 wherein said multilayer region comprises alternating layers of carbon nanotubes, polyacrylic acid and polyethylene imine.

12. The expandable medical balloon of claim 11 wherein the multilayer region comprises a first layer of polyethylene imine, the polyethylene imine is deposited on the poly(ether-block-amide).

13. The expandable medical balloon of claim 12 wherein the multilayer region comprises a second layer of polyacrylic acid, the polyacrylic acid is deposited on the first layer of polyethylene imine.

14. The expandable medical balloon of claim 1 wherein said polymer layer is provided with functional groups having a negative charge.

15. The expandable medical balloon of claim 14 wherein said functional groups comprise a member selected from the group consisting of a carboxylic, phosphonic, phosphoric, sulfuric and sulfonic.

16. The expandable medical balloon of claim 1 wherein said therapeutic agent is selected from antithrombotic agents, anti-proliferative agents, anti-inflammatory agents, anti-migratory agents, agents affecting extracellular matrix production and organization, antineoplastic agents, anti-mitotic agents, anesthetic agents, anti-coagulants, vascular cell growth promoters, vascular cell growth inhibitors, cholesterol-lowering agents, vasodilating agents, and agents that interfere with endogenous vasoactive mechanisms.

17. The expandable medical balloon of claim 16 wherein the therapeutic agent is provided with a charge.

18. The expandable medical balloon of claim 17 wherein the therapeutic agent comprises functional groups at least one of which is a member selected from the group consisting of carboxylic, phosphonic, phosphoric, sulfuric and sulfonic.

19. The expandable medical balloon of claim 17 wherein the therapeutic agent comprises functional groups at least one of which is a member selected from the group consisting of amine and imine.

20. The expandable medical balloon of claim 1u wherein the therapeutic agent is charged and comprises at least one member selected from the group consisting of polynucleotides and polypeptides.