Coatings with tunable solubility profile for drug-coated balloon

• US 8,480,620 B2
• Filed: 12/11/2009
• Issued: 07/09/2013
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Stankus, John, Trollsas, Mikael, Hossainy, Syed
• Primary Examiner(s): Krass, Frederick
• Assistant Examiner(s): Milligan, Adam C
• Application Number:
  US12/636,124
• Publication Number:
  US 20110144582A1
• Time in Patent Office: 1,306 Days
• Field of Search: 604/103.02
• US Class Current: 604/103.02
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• 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

Abstract

A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Claims

1. A balloon for delivery of a drug, the balloon comprising

a body having an outer surface;

and

a coating disposed on at least a length of the outer surface, the coating including zotarolimus and at least one excipient, wherein the zotarolimus to excipient weight ratio is from about 20;

1 to about 1;

20, wherein the at least one excipient includes polyvinylpyrrolidone, and further wherein the at least one excipient increases the solubility of the zotarolimus to between 4 μ

g/ml to 1437 μ

g/ml.

2. The balloon of claim 1, wherein the zotarolimus to excipient weight ratio is from about 2:

1 to about 1;

2.

3. The balloon of claim 1, wherein the coating further includes a plasticizer.

4. The balloon of claim 3, wherein the excipient to plasticizer weight ratio is from about 20:

1 to about 1;

20.

5. The balloon of claim 4, wherein the excipient to plasticizer weight ratio is from about 10:

1 to about 1;

1.

6. The balloon of claim 3, wherein the plasticizer is glycerol.

7. The balloon of claim 1, wherein the at least one excipient includes a blend of polyvinylpyrrolidone having two different average molecular weights.

8. The balloon of claim 1, wherein the at least one excipient is blended with a contrast agent.

9. The balloon of claim 1, wherein the at least one excipient includes a polymer having a molecular weight of less than about 35 kDalton.

10. The balloon of claim 1, further comprising a second excipient, wherein the second excipient is a polymer having a molecular weight greater than about 100 kDalton.