Apparatus and methods for restoring tissue

Abstract

An apparatus and methods tissue restoration are provided. The apparatus may include a catheter shaft extending from a proximal end to a distal tip and a translucent first distal balloon positioned on a translucent distal segment of the catheter shaft inside of and concentric with a second distal balloon proximal to the distal tip in fluid communication with a drug source via a first lumen, the first distal balloon may include first and second outer surfaces, and longitudinal and circumferential channels. A first light fiber and a second light fiber each positioned in the catheter shaft and extending through the translucent distal segment. The drug source provides at least one drug to the first distal balloon via the first lumen.

1 - 20 . (canceled) 
     
     
         21 . An apparatus comprising:
 a catheter shaft extending from a proximal end to a distal tip;   a first distal balloon positioned on a translucent distal segment of the catheter shaft proximal to the distal tip and positioned inside of and concentric with a second distal balloon, the first distal balloon in fluid communication with a drug source via a first lumen, the first distal balloon comprising:
 a translucent material; 
 a plurality of circumferential channels recessed from the outermost radial surfaces of the first distal balloon; and 
   at least one light fiber positioned in the catheter shaft and extending through the translucent distal segment.   
     
     
         22 . The apparatus of  claim 21 , wherein the second distal balloon comprises a plurality of slitted apertures radially aligned with a plurality of outermost radial surfaces of the first distal balloon, the slitted apertures selectively communicate a drug from the first distal balloon to a treatment area of a subject. 
     
     
         23 . The apparatus of  claim 22 , wherein the slitted apertures are positioned away from the circumferential channels of the first distal balloon. 
     
     
         24 . The apparatus of  claim 22 , wherein the slitted apertures of the second distal balloon remain in contact with the outermost radial surfaces of the first distal balloon, sealing the slitted apertures closed during inflation and deflation of the first distal balloon. 
     
     
         25 . The apparatus of  claim 22 , wherein during inflation of the second distal balloon, the drug fills between an inside surface of the second distal balloon and an outside surface of the first distal balloon, gradually filling the circumferential channels. 
     
     
         26 . The apparatus of  claim 25 , wherein a pressure of the drug between the inside surface of the second distal balloon and the outside surface of the first distal balloon increases and inflates the second distal balloon, the increased pressure forces edges of the slitted apertures to open apart thereby reducing the pressure. 
     
     
         27 . The apparatus of  claim 22 , wherein inflation of the second distal balloon moves the slitted apertures away from the outermost radial surfaces of the first distal balloon allowing the slitted apertures to open and permit fluid flow to the treatment area. 
     
     
         28 . The apparatus of  claim 21  wherein the distal segment, the first distal balloon, and the second distal balloon are at least partially transparent. 
     
     
         29 . The apparatus of  claim 21  wherein the at least one light fiber provides light activation through the distal segment, the first distal balloon, and the second distal balloon. 
     
     
         30 . The apparatus of  claim 21  wherein the circumferential channels are non-deformable and are configured to assist to provide uniform drug delivery through the second distal balloon. 
     
     
         31 . The apparatus of  claim 21  wherein the second distal balloon comprises material that is conformable to the morphology of the vessel wall. 
     
     
         32 . A method of tissue restoration in a blood vessel of a subject comprising:
 providing a catheter into the blood vessel, the catheter comprising:
 a catheter shaft extending from a proximal end to a distal tip; 
 a first distal balloon positioned on a translucent distal segment of the catheter shaft proximal to the distal tip and positioned inside of and concentric with a second distal balloon, the first distal balloon in fluid communication with a drug source via a first lumen, the first distal balloon comprising: 
 a translucent material; 
 a plurality of circumferential channels recessed from the outermost radial surfaces of the first distal balloon; 
 the second distal balloon comprises a plurality of slitted apertures radially aligned with a plurality of outermost radial surfaces of the first distal balloon, the slitted apertures selectively communicate a drug from the first distal balloon to a treatment area of a subject; and 
 at least one light fiber positioned in the catheter shaft and extending through the translucent distal segment; 
   supplying the drug from the drug source to the first distal balloon;   delivering the drug to the treatment area through the slitted apertures; and   activating the at least one light fiber thereby providing light transmission through the distal segment, the first distal balloon, and the second distal balloon to activate the drug in the treatment area.   
     
     
         33 . The method of  claim 32  further comprising:
 gradually filling the drug into a volume of the circumferential channels between an inside surface of the second distal balloon and an outside surface of the first distal balloon; 
 expanding the second distal balloon, thereby moving the slitted apertures away from the outermost radial surfaces of the first distal balloon. 
 
     
     
         34 . The method of  claim 32 , wherein the slitted apertures are positioned away from the circumferential channels of the first distal balloon. 
     
     
         35 . The method of  claim 32 , further comprising contracting the second distal balloon as the drug is delivered through the slitted apertures. 
     
     
         36 . The method of  claim 35 , wherein contracting the second distal balloon moves the second distal balloon into contact with the outermost radial surfaces of the first distal balloon and closes the slitted apertures, causing drug delivery to stop. 
     
     
         37 . The method of  claim 33 , wherein a pressure of the drug between the inside surface of the second distal balloon and the outside surface of the first distal balloon increases and inflates the second distal balloon, the increased pressure forces edges of the slitted apertures to open apart thereby reducing the pressure. 
     
     
         38 . The method of  claim 32 , wherein the at least one light fiber provide light activation through the distal segment, the first distal balloon, and the second distal balloon. 
     
     
         39 . The method of  claim 32 , wherein the slitted apertures are positioned away from the circumferential channels of the first distal balloon. 
     
     
         40 . An apparatus comprising:
 a catheter shaft extending from a proximal end to a distal tip;   a first distal balloon positioned on a translucent distal segment of the catheter shaft proximal to the distal tip and positioned inside of and concentric with a second distal balloon, the first distal balloon in fluid communication with a drug source via a first lumen, the first distal balloon comprising:
 a translucent material; 
 a plurality of circumferential channels recessed from the outermost radial surfaces of the first distal balloon; 
   at least one light fiber each positioned in the catheter shaft and extending through the translucent distal segment; and   wherein the drug source is configured to provide at least one drug to the first distal balloon via the first lumen and during inflation of the second distal balloon, a fluid fills between an inside surface of the second distal balloon and an outside surface of the first distal balloon, and gradually fills the circumferential channels.