Apparatus and method for delivering intraluminal therapy

Abstract

A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent. The outer balloon may include protrusions that contact the vessel wall to disrupt the plaque, bumpers to reduce washout during infusion of therapeutic agents; the intermediate balloon may include a texture, ribs or protrusions on its outer surface to prevent adhesion to the outer balloon during dilation of the vessel; and the catheter may include a guide wire lumen sized to accept an energy delivery device to delivery energy that enhances uptake of the therapeutic agent or prolongs therapeutic effectiveness of the is agent.

What is claimed is: 
     
         1 . An apparatus for infusing a therapeutic agent into a luminal wall, the apparatus comprising:
 an elongated catheter shaft having a proximal end and a distal region, and an infusion lumen extending from the proximal end to the distal region;   a first balloon affixed to the distal region of the elongated catheter shaft; and   a second balloon affixed to the distal region to envelop the first balloon so as to define a space between the first balloon and the second balloon, the second balloon having an exterior surface with a multiplicity of through-wall apertures and extensions extending beyond the exterior surface having the multiplicity of through-wall apertures,   wherein the second balloon is adapted to expand such that the extensions contact the luminal wall to create a pocket between the exterior surface of the second balloon and the luminal wall, and   wherein the infusion lumen is configured to permit delivery of the therapeutic agent into the space, through the multiplicity of through-wall apertures, into the pocket, and to the luminal wall.   
     
     
         2 . The apparatus of  claim 1 , wherein the extensions are adapted to reduce clogging of the multiplicity of through-wall apertures when the extensions are urged into contact with the luminal wall. 
     
     
         3 . The apparatus of  claim 1 , wherein the extensions are adapted to reduce the amount of therapeutic agent washed into systemic circulation during therapeutic agent delivery. 
     
     
         4 . The apparatus of  claim 1 , wherein the extensions comprise a proximal bumper extending around a circumference of a proximal side of the second balloon and a distal bumper extending around a circumference of a distal side of the second balloon. 
     
     
         5 . The apparatus of  claim 1 , wherein the extensions comprise a multiplicity of protrusions interposed between the multiplicity of through-wall apertures. 
     
     
         6 . The apparatus of  claim 5 , wherein the multiplicity of through-wall apertures are offset from the multiplicity of protrusions so as to reduce clogging of the apertures when the protrusions are urged into contact with the luminal wall. 
     
     
         7 . The apparatus of  claim 5 , wherein at least some of the protrusions of the multiplicity of protrusions have a cylindrical, rectangular, conical, or pyramidal shape. 
     
     
         8 . The apparatus of  claim 5 , wherein at least some of the protrusions of the multiplicity of protrusions are configured to form a spiral around a circumference of the second balloon. 
     
     
         9 . The apparatus of  claim 1 , wherein at least some of the apertures of the multiplicity of apertures have a circular, rectangular, elliptical, or triangular shape. 
     
     
         10 . The apparatus of  claim 1 , wherein expansion of the second balloon is adapted to dilate a lumen having the luminal wall and to disrupt plaque. 
     
     
         11 . The apparatus of  claim 1 , further comprising a multiplicity of protrusions disposed an exterior surface of the first balloon to prevent adhesion of the first balloon to the second balloon during dilatation of the luminal wall. 
     
     
         12 . The apparatus of  claim 1 , wherein the first balloon has a multiplicity of through-wall apertures offset from the multiplicity of through-wall apertures of the second balloon. 
     
     
         13 . The apparatus of  claim 1 , wherein the elongated catheter shaft further comprises a lumen sized to accept an energy delivery device, the energy delivery device configured to deposit energy into the therapeutic agent and the luminal wall. 
     
     
         14 . The apparatus of  claim 1 , further comprising a third balloon, wherein the first balloon is configured to envelop the third impermeable balloon. 
     
     
         15 . The apparatus of  claim 1 , further comprising an inflation lumen extending from the proximal end to the distal region of the elongated catheter shaft. 
     
     
         16 . The apparatus of  claim 1 , wherein the therapeutic agent comprises one or more regenerative agents, anti-inflammatory agents, anti-allergenic agents, anti-bacterial agents, anti-viral agents, anticholinergic agents, antihistamines, antithrombotic agents, anti-scarring agents, antiproliferative agents, antihypertensive agents, anti-restenosis agents, healing promoting agents, vitamins, proteins, genes, growth factors, cells, stem cells, vectors, RNA, DNA, or any combination thereof. 
     
     
         17 . The apparatus of  claim 1 , wherein the luminal wall is of a blood vessel and the therapeutic agent is injected into an intima layer, an adventitia layer, or a medial layer, or any combination thereof, of the blood vessel. 
     
     
         18 . The apparatus of  claim 1 , wherein the therapeutic agent comprises an anti-proliferative drug configured to reduce occurrence of restenosis or a regenerative therapy agent configured to promote angiogenesis, or both. 
     
     
         19 . A method for infusing a therapeutic agent into a luminal wall, the method comprising:
 advancing a distal region of an elongated catheter shaft into a body lumen, the distal region having first and second balloons affixed thereto such that the second balloon envelops the first balloon so as to define a space between the first balloon and the second balloon, the second balloon having an exterior surface with a multiplicity of through-wall apertures and extensions extending beyond the exterior surface having the multiplicity of through-wall apertures;   expanding the outer balloon such that the extensions contact the luminal wall of the body lumen to create a pocket between the exterior surface of the second balloon and the luminal wall; and   delivering the therapeutic agent into the space, through the multiplicity of through-wall apertures, into the pocket, and to the luminal wall.   
     
     
         20 . The method of  claim 19 , wherein expanding the outer balloon comprises expanding the outer balloon such that the extensions contact the luminal wall of the body lumen to create the pocket to reduce clogging of the multiplicity of through-wall apertures when the extensions are urged into contact with the luminal wall and to reduce the amount of therapeutic agent washed into systemic circulation during therapeutic agent delivery.