Method and apparatus for treating vulnerable plaque

Abstract

An apparatus and method to treat vulnerable plaque. In one embodiment, the apparatus has an elongated catheter body adapted for insertion in a body lumen, with a drug delivery device attached near a distal portion of the elongated body. The drug delivery device is configured to deliver a biologically active agent to stabilize a vulnerable plaque.

1 . An apparatus, comprising: 
 an elongated catheter body adapted for insertion in a body lumen; and    a drug delivery device coupled near a distal portion of said elongated body, said drug delivery device configured to deliver a biologically active agent to stabilize a vulnerable plaque.    
   
   
       2 . The apparatus of  claim 1 , wherein said drug delivery device comprises: 
 a balloon disposed at a distal end of said drug delivery device; and    at least one needle housed within said drug delivery device, wherein said at least one needle is moveable from a retracted position to an extended position, and wherein an angle of needle penetration relative to said elongated catheter body corresponds to an inflation of said balloon.    
   
   
       3 . The apparatus of  claim 2 , further comprising a sensor near said distal portion of said catheter, wherein said sensor determines a penetration depth of said at least one needle.  
   
   
       4 . The apparatus of  claim 1 , wherein said biologically active agent comprises lipid lowering agents.  
   
   
       5 . The apparatus of  claim 1 , wherein said biologically active agent comprises antioxidants.  
   
   
       6 . The apparatus of  claim 1 , wherein said biologically active agent comprises anti-inflammatory agents.  
   
   
       7 . The apparatus of  claim 1 , wherein said biologically active agent comprises extracellular matrix synthesis promoters.  
   
   
       8 . The apparatus of  claim 1 , wherein said drug delivery device delivers up to 600 μg of said biologically active agent.  
   
   
       9 . A method for stabilizing a vulnerable plaque in a lumen wall, comprising: 
 detecting said vulnerable plaque;    advancing a needle catheter near said vulnerable plaque; and    delivering a vulnerable plaque stabilizing agent with said needle catheter near said vulnerable plaque.    
   
   
       10 . The method of  claim 9 , further comprising determining a penetration depth of said needle catheter.  
   
   
       11 . (canceled)  
   
   
       12 . The method of  claim 9 , wherein delivering said vulnerable plaque stabilizing drug comprises targeting an intimal layer near said vulnerable plaque.  
   
   
       13 . The method of  claim 9 , wherein delivering said vulnerable plaque stabilizing drug comprises targeting an adventitial layer near said vulnerable plaque.  
   
   
       14 . The method of  claim 9 , wherein delivering said vulnerable plaque stabilizing drug comprises targeting a media layer near said vulnerable plaque.  
   
   
       15 . The method of  claim 9 , wherein delivering said vulnerable plaque stabilizing drug comprises targeting said lipid core of said vulnerable plaque region.  
   
   
       16 . The method of  claim 15 , wherein targeting said lipid core comprises delivering a cross-linking agent.  
   
   
       17 . A method of  claim 15 , wherein targeting said lipid core comprises delivering a matrix-ase inhibitor.  
   
   
       18 . The method of  claim 13 , wherein targeting said adventitial layer comprises delivering a collagen synthesis promoter.  
   
   
       19 . The method of  claim 13 , wherein targeting said adventitial layer comprises gene therapy.  
   
   
       20 . The method of  claim 13 , wherein targeting said adventitial layer comprises inserting said needle into said body lumen wall at a point proximal to said vulnerable plaque region, and extending said needle to said adventitial layer.  
   
   
       21 . The method of  claim 14 , wherein targeting said media layer comprises inserting said needle into said body lumen wall at a point proximal to said vulnerable plaque region, and extending said needle to said media layer.  
   
   
       22 . (canceled)  
   
   
       23 . The method of  claim 15 , wherein targeting said lipid core comprises inserting said needle into said body lumen wall at a point proximal to said lipid core, and extending said needle to said lipid core.  
   
   
       24 . The method of  claim 9 , wherein said vulnerable plaque stabilizing agent strengthens said fibrous cap.  
   
   
       25 . The method of  claim 9 , wherein said vulnerable plaque stabilizing agent reduces a size of a lipid core of said vulnerable plaque.  
   
   
       26 . The method of  claim 9 , wherein said vulnerable plaque stabilizing agent thickens said fibrous cap.  
   
   
       27 . A method for treating a vulnerable plaque, comprising: 
 advancing a medical device within a body lumen; and    delivering a biologically active agent from said medical device, wherein said biologically active agent induces a therapeutic angiogensesis growth away from said vulnerable plaque to maintain a blood perfusion in the event of an occlusive thrombosis from a rupturing of said vulnerable plaque.    
   
   
       28 . The method of  claim 27 , wherein delivering comprises releasing said biologically active agent upstream from said vulnerable plaque.  
   
   
       29 . A method of  claim 28 , further comprising providing a drug delivery catheter to release said biologically active agent.  
   
   
       30 . The method  claim 27 , wherein delivering comprises releasing said biologically active agent through a bloodstream near said vulnerable plaque.  
   
   
       31 . The method  claim 27 , wherein delivering comprises releasing said biologically active agent towards a lumen wall near said vulnerable plaque.  
   
   
       32 . The method  claim 27 , wherein delivering comprises sustained-releasing said biologically active agent.  
   
   
       33 . The method of  claim 32 , wherein sustained-releasing said biologically active agent comprises releasing said biologically active agent over a period up to about 6 months.  
   
   
       34 . The method of  claim 29 , wherein said drug delivery catheter comprises dip coating a drug eluting stent with said biologically active agent.  
   
   
       35 . The method of  claim 29 , wherein said drug delivery catheter comprises spin coating a drug eluting stent with said biologically active agent.  
   
   
       36 . The method of  claim 31 , wherein releasing said biologically active agent towards said lumen wall comprises adhering a plurality of micro-particles to said lumen wall.  
   
   
       37 . The method of  claim 27 , wherein said biologically active agent is selected from a group consisting of vascular endothelial growth factor (VEGF), fibroblast growth factors, monocyte chemoatractant protein 1 (MCP-1), transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta, DEL-1, insulin like growth factors (IGF), placental growth factor (PLGF), hepatocyte growth factor (HGF), prostaglandin E1 (PG-E1), prostaglandin E2 (PG-E2), tumor necrosis factor alpha (TBF-alpha), granulocyte stimulating growth factor (G-CSF), granulocyte macrophage colony-stimulating growth factor (GM-CSF), angiogenin, follistatin, proliferin, pro-angiogenic peptides, and pro-angiogenic small molecules.  
   
   
       38 . The method of  claim 27 , wherein delivering said biologically active agent induces a therapeutic angiogenesis growth to a myocardium.  
   
   
       39 . The method of  claim 27 , wherein delivering said biologically active agent comprises delivering up to 600 μg of said biologically active agent.  
   
   
       40 . An apparatus for stabilizing a vulnerable plaque in a lumen wall, comprising: 
 means for detecting said vulnerable plaque;    means for advancing a needle catheter near said vulnerable plaque; and    means for delivering a vulnerable plaque stabilizing agent with said needle catheter near said vulnerable plaque, wherein said vulnerable plaque stabilizing agent increases a thickness of a fibrous cap.    
   
   
       41 . An apparatus for treating a vulnerable plaque, comprising: 
 means for advancing a medical device within a body lumen; and    means for delivering a biologically active agent from said medical device, wherein said biologically active agent induces a therapeutic angiogenesis growth away from said vulnerable plaque to maintain a blood perfusion in the event of an occlusive thrombosis from a rupturing of said vulnerable plaque.