Device for Treating Hardened Lesions and Method of Use Thereof
A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.
1 . A device comprising:
a shaft having a distal end and a proximal end;
a expandable balloon mounted at the distal end of the shaft, the shaft having a lumen extending therethrough and in fluid communication with an interior region of the balloon, and
a cutting element on an exterior surface of the balloon, wherein at least one channel extends from the interior region of the balloon through the cutting element, thereby providing fluid communication between the interior region and the exterior surface of the balloon.
2 . The device of claim 1 , comprising a plurality of cutting elements.
3 . The device 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, a superelastic nickel-titanium alloy, and inconel.
4 . The device 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, or mixtures or copolymers thereof.
5 . The device of claim 1 , further comprising a fluid comprising a bioactive within the interior region of the balloon.
6 . The device of claim 5 , wherein the bioactive is selected from the group consisting of paclitaxel, rapamycin, a rapamycin derivative, an antisense oligonucleotide, and a mTOR inhibitor.
7 . The device of claim 5 , wherein the bioactive is paclitaxel.
8 . The device of claim 1 , wherein the cutting element is partially imbedded within the balloon.
9 . The device of claim 1 , wherein the balloon comprises a material selected from the group consisting of silicone, polyethyleneterephthalate (PET), polyvinyl chloride, polypropylene, polyethylene, polyurethanes, nylons, polyesters, latex, natural rubber, synthetic rubber, elastomers and mixtures or copolymers thereof.
10 . The device of claim 1 , wherein the cutting element comprises an elongated blade.
11 . The device of claim 10 , wherein the elongated blade comprises a plurality of channels.
12 . The device of claim 1 , wherein the cutting element comprises a sharpened edge.
13 . The device of claim 1 , wherein the cutting element has a helical or serpentine form.
14 . The device of claim 1 , wherein the cutting element and the balloon each comprise a polymeric material.
15 . The device of claim 1 , further comprising a second balloon, wherein the second balloon in positioned within the expandable balloon and wherein the lumen is in fluid communication with an interior region between the expandable balloon and the second balloon.
16 . A device comprising:
a shaft having a distal end and a proximal end;
a expandable balloon mounted at the distal end of the shaft, the shaft having a lumen extending therethrough and in fluid communication with an interior region of the balloon,
a cutting element on an outside surface of the balloon, wherein at least one channel extends from the interior region of the balloon and through the cutting element, and
a fluid comprising a bioactive within the interior region of the balloon, wherein the bioactive is paclitaxel.
17 . The device of claim 16 , wherein the bioactive is paclitaxel.
18 . A method of delivering a bioactive 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;
a expandable balloon mounted at the distal end of the shaft, the shaft having a lumen extending therethrough and in fluid communication with an interior region of the balloon, and
a cutting element on an outside surface of the balloon, wherein at least one channel extends from the interior region of the balloon and through the cutting element,
introducing an inflation fluid through the lumen into the interior region of the balloon, thereby expanding the balloon to cause the cutting element to contact the vessel wall, wherein the inflation fluid comprises a bioactive, and
maintaining contact with the vessel wall for a time sufficient to deliver a therapeutically effective amount of bioactive to the vessel wall, wherein the bioactive is delivered through the at least one channel extending from the interior region of the balloon and through the cutting element.
19 . The method of claim 18 , therein the bioactive is paclitaxel.