Device for treating hardened lesions and method of use thereof

1. A method of delivering a bioactive agent to a vessel wall, the method comprising:

positioning an expandable balloon portion of a balloon catheter at a site within a vessel, wherein the balloon catheter comprises:

a shaft having a distal end and a proximal end;

an expandable inner balloon mounted at the distal end of the shaft, the shaft having an inflation lumen extending therethrough and in fluid communication with an interior region of the inner balloon,

an expandable outer balloon positioned around the inner balloon and defining an intermediate region between the inner balloon and the outer balloon, the shaft having a delivery lumen extending therethrough and in fluid communication with the intermediate region, and

at least one cutting element on an exterior surface of the inner balloon and positioned entirely within the intermediate region,

wherein the outer balloon comprises a plurality of pores providing fluid communication between the intermediate region and an exterior of the balloon catheter and wherein the at least one cutting element is not extendable through any of the plurality of pores,

expanding the inner balloon to a degree sufficient to contact the vessel wall with the outer balloon and to apply a cutting or scoring pressure to the vessel wall with the at least one cutting element, wherein the cutting or scoring pressure is applied through the wall of the outer balloon;

delivering a composition comprising the bioactive agent to the intermediate region via the delivery lumen; and

maintaining the outer balloon in contact with the vessel wall for a time sufficient to deliver a therapeutically effective amount of the bioactive agent through the plurality of pores to the vessel wall.

2. The method of claim 1 , wherein the vessel is selected from the group consisting of a vein, an artery, a biliary duct, an ureteral vessel and an alimentary canal.

3. The method of claim 2 , wherein the vessel is selected from the group selected from the group consisting of a vein and an artery.

4. The method of claim 3 , wherein the artery is selected from the group consisting of a coronary artery, a carotid artery and a peripheral artery.

5. The method of claim 4 , therein the artery is a peripheral artery.

6. The method of claim 5 , wherein the bioactive agent is paclitaxel.

7. The method of claim 1 , wherein the bioactive agent is selected from the group consisting of paclitaxel, rapamycin, a rapamycin derivative, an antisense oligonucleotide, and an mTOR inhibitor.

8. The method of claim 7 , wherein the bioactive agent is paclitaxel.

9. The method of claim 1 , wherein the vessel is the vessel of a human patient.

10. The method of claim 9 , wherein the vessel is an artery.

11. The method of claim 1 , wherein the bioactive agent is selected from the group consisting of an antiproliferative agent, an antimitotic agent, an antibiotic, a hormone, an anti-inflammatory agent, an immunosuppressive agent, an antibody, a statin, an endothelial progenitor cell and an endothelial cell.

12. The method of claim 1 , wherein the cutting element comprises a material selected from the group consisting of stainless steel, nickel, silver, platinum, palladium, gold, titanium, tantalum, iridium, tungsten, and a superelastic nickel-titanium alloy.

13. The method of claim 1 , wherein the cutting element comprises a material selected from the group consisting of carbon, carbon fiber, cellulose acetate, cellulose nitrate, silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polyanhydride, polycarbonate, polypropylene, high molecular weight polyethylene, polylactic acid, polyglycolic acid, polytetrafluoroethylene, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a biocompatible polymeric material, and mixtures and copolymers thereof.

14. The method of claim 1 , wherein at least one of the outer balloon and the inner balloon comprises a material selected from the group consisting of silicone, a biocompatible polymer, polyethyleneterepthalate, polyvinyl chloride, polypropylene, polyethylene, polyurethane, nylon, polyester, latex, natural rubber, synthetic rubber, an elastomer and mixtures and copolymers thereof.

15. The method of claim 1 , wherein the cutting element and the inner balloon comprise a biocompatible polymer.

16. The method of claim 1 , wherein the balloon catheter is a rapid exchange balloon catheter.

17. The method of claim 1 , wherein the bioactive agent is delivered to treat a stenosis or restenosis of the vessel.

18. The method of claim 1 , wherein the bioactive agent is delivered to a hardened portion of the vessel wall.

19. A method of delivering paclitaxel to a vessel wall, the method comprising:

positioning an expandable balloon portion of a balloon catheter at a site within a vessel, wherein the balloon catheter comprises:

a shaft having a distal end and a proximal end;

an expandable inner balloon mounted at the distal end of the shaft, the shaft having an inflation lumen extending therethrough and in fluid communication with an interior region of the inner balloon,

an expandable outer balloon positioned around the inner balloon and defining an intermediate region between the inner balloon and the outer balloon, the shaft having a delivery lumen extending therethrough and in fluid communication with the intermediate region, and

at least one cutting element on an exterior surface of the inner balloon and positioned entirely within the intermediate region,

wherein the outer balloon comprises a plurality of pores providing fluid communication between the intermediate region and an exterior of the balloon catheter and wherein the at least one cutting element is not extendable through any of the plurality of pores,

expanding the inner balloon to a degree sufficient to contact the vessel wall with the outer balloon and to apply a cutting or scoring pressure to the vessel wall with the at least one cutting element, wherein the cutting or scoring pressure is applied through the wall of the outer balloon;

delivering a composition comprising the paclitaxel to the intermediate region via the delivery lumen; and

maintaining the outer balloon in contact with the vessel wall for a time sufficient to deliver a therapeutically effective amount of the paclitaxel through the plurality of pores to the vessel wall,

wherein the vessel is a peripheral artery of a human patient.