THERAPEUTIC DRIVING LAYER FOR A MEDICAL DEVICE

• US 20080215137A1
• Filed: 08/08/2007
• Published: 09/04/2008
• Est. Priority Date: 04/30/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: EPSTEIN, Samuel J., NAIMARK, Wendy, PANOS, Anastasia, OSTROVSKY-DAY, Irina
• Application Number:
  US11/835,787
• Publication Number:
  US 20080215137A1
• Time in Patent Office: Days
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention regards the delivery of therapeutic at a target site. Systems that employ the present invention may employ a medical device sized to be inserted into a target site, a driving layer covering at least a portion of an accessible surface of the medical device, and a therapeutic interfaced with at least a portion of the driving layer. In this system, the driving layer may have a material characteristic that serves to release the therapeutic from the medical device when the medical device is at the target site. Other systems that employ the invention may also have properties that include having a driving layer with a higher solubility than the therapeutic at the target site, a medical device that is hydrophobic while the therapeutic is hydrophilic, and a coating covering at least a portion of the therapeutic.

Claims

1. A medical device comprising:

a second coating layer disposed over a surface of the medical device, wherein the second coating layer comprises a therapeutic agent; and

a first coating layer disposed between the surface of the medical device and the second coating layer, wherein the first coating layer comprises a material that enhances the delivery of the therapeutic agent to body tissue.

2. The medical device of claim 1, wherein the first coating layer is a driving layer having a driving material that promotes the release of the therapeutic agent from the second coating layer, and wherein the driving material has a higher aqueous solubility than the therapeutic agent.

3. The medical device of claim 1, wherein the first coating layer is a driving layer having a driving material that promotes the release of the therapeutic agent from the second coating layer, and wherein the driving material is biodegradable in body fluid or tissue.

4. The medical device of claim 2, wherein the surface of the medical device is hydrophobic and the therapeutic agent is hydrophilic.

5. The medical device of claim 2, further comprising a third coating layer disposed over at least a portion of the second coating layer.

6. The medical device of claim 2, wherein the driving layer also serves to retain the second coating layer on the medical device.

7. The medical device of claim 2, wherein the driving layer is a protein and the therapeutic agent is DNA.

8. The medical device of claim 2, wherein the medical device is a stent.

9. The medical device of claim 2, wherein the therapeutic agent is DNA and wherein the driving material is a transfection agent.

10. The medical device of claim 2, wherein the driving material is selected from the group consisting of:

an ionic salt, an ionic surfactant, a non-ionic surfactant, a lipid, a polysaccharide, Dextran, a foaming agent, and a block co-polymer.

11. The medical device of claim 1, wherein the medical device is a bone implant.

12. The medical device of claim 2, wherein the driving layer effects the complete release of the therapeutic agent from the second coating layer when the medical device is at the target site.

13. A method for delivering a therapeutic agent to a body tissue, comprising:

providing a medical device comprising;

(a) a second coating layer disposed over a surface of the medical device, wherein the second coating layer comprises a therapeutic agent; and

(b) a first coating layer disposed between the surface of the medical device and the second coating layer, wherein the first coating layer comprises a material that enhances the delivery of the therapeutic agent to body tissue; and

delivering the medical device to the body tissue.

14. The method of claim 13, wherein the first coating layer is a driving layer having a driving material that promotes the release of the therapeutic agent from the second coating layer, and wherein the driving material has a higher aqueous solubility than the therapeutic agent.

15. The method of claim 14, further comprising implanting the medical device in the body tissue.

16. The method of claim 14, wherein the driving material promotes the release of the therapeutic agent from the second coating layer, and wherein the driving material is biodegradable in body fluid or tissue.

17. The method of claim 14, wherein the surface of the medical device is hydrophobic and the therapeutic agent is hydrophilic.

18. The method of claim 14, further comprising a third coating layer disposed over at least a portion of the second coating layer.

19. The method of claim 14, wherein the therapeutic agent is DNA and wherein the driving material is a transfection agent.

20. The method of claim 14, wherein the driving material is selected from the group consisting of:

an ionic salt, an ionic surfactant, a non-ionic surfactant, a lipid, a polysaccharide, Dextran, a foaming agent, and a block co-polymer.