Use of nanocrystals for drug delivery from a balloon

Patent metadata

Field	Value
Publication number	US-11278648-B2
Application number	US-201916533263-A
Country	US
Kind code	B2
Filing date	Aug 6, 2019
Priority date	Jul 10, 2009
Publication date	Mar 22, 2022
Grant date	Mar 22, 2022

Abstract

A drug delivery balloon (10) has a drug thereon in the form of crystalline particles (12), the drug having a predetermined size distribution. Optionally marker particles (14, 16) are also provided. A texturized coating (18), a cap layer (20) and/or other methods may be used to increase particle loading capacity of the balloon.

First claim

What is claimed is:

1. A drug delivery balloon adapted for delivery of a drug to a site in a body passageway, the balloon comprising:
a balloon wall with an outer surface and the balloon having a drug disposed on the outer surface,
wherein the drug is provided on the balloon as crystalline particles of the drug in a size distribution in the range of from 0.01 mm to 2 mm,
wherein the crystalline drug particles comprise paclitaxel, and
wherein the crystalline drug particles are present in mixture with a water soluble excipient material.

2. The balloon of claim 1 , wherein the water soluble excipient material comprises a water soluble polymer.

3. The balloon of claim 1 , wherein the water soluble excipient material comprises one or more of a sugar, a polysaccharide, a contrast agent, a citrate ester, and a pharmaceutically acceptable salt.

4. The balloon of claim 1 , wherein the water soluble excipient material includes a citrate ester.

5. The balloon of claim 4 , wherein the citrate ester includes acetyl tri-butyl citrate.

6. The balloon of claim 1 , wherein the balloon includes a textured surface.

7. The balloon of claim 1 , wherein the balloon includes 50 to 1000 micrograms of paclitaxel.

8. The balloon of claim 1 , further comprising marker particles admixed with the crystalline drug particles.

9. A drug delivery balloon catheter, comprising:
a catheter shaft;
a balloon coupled to the catheter shaft, the balloon having a balloon wall with an outer surface;
a drug coating disposed along the outer surface;
wherein the drug coating comprises crystalline paclitaxel particles and a water soluble excipient material; and
wherein the crystalline paclitaxel particles have a size distribution in the range of from 0.01 mm to 2 mm.

10. The balloon catheter of claim 9 , wherein the water soluble excipient material comprises a water soluble polymer.

11. The balloon catheter of claim 9 , wherein the water soluble excipient material comprises one or more of a sugar, a polysaccharide, a contrast agent, a citrate ester, and a pharmaceutically acceptable salt.

12. The balloon catheter of claim 9 , wherein the water soluble excipient material includes a citrate ester.

13. The balloon catheter of claim 12 , wherein the citrate ester includes acetyl tri-butyl citrate.

14. The balloon catheter of claim 9 , wherein the outer surface is textured.

15. The balloon catheter of claim 9 , wherein the drug coating includes 50 to 1000 micrograms of crystalline paclitaxel particles.

16. The balloon catheter of claim 9 , wherein the drug coating includes marker particles admixed with the crystalline paclitaxel particles.

17. A drug delivery balloon, comprising:
a balloon wall having an outer surface;
a drug coating disposed along the outer surface;
wherein the drug coating comprises crystalline paclitaxel particles and a water soluble excipient material; and
wherein the crystalline paclitaxel particles have a size distribution in the range of from 0.01 mm to 2 mm.

18. The balloon catheter of claim 17 , wherein the water soluble excipient material includes a citrate ester.

19. The balloon catheter of claim 18 , wherein the citrate ester includes acetyl tri-butyl citrate.

20. The balloon catheter of claim 17 , wherein the outer surface is textured.

Assignees

• Boston Scient Scimed Inc

Inventors

• Flanagan Aiden
• Weber Jan
• Clarke John

Classifications

• A61L2300/63

  Crystals · CPC title

• A61L2300/624

  Nanocapsules · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61L2300/416

  Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus · CPC title

• A61L29/16 Primary

  Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} · CPC title