Anti-arrhythmia devices and methods of use

Abstract

An apparatus and method of use are disclosed for treating, preventing and terminating arrhythmias. In particular, the apparatus is implantable within or on various tissues and structures and is used to prevent or block conduction of aberrant impulses. A variety of methods of the present invention may be used to attack arrhythmias by short-circuiting impulses, inducing fibrosis, ablating tissue or inducing inflammation. In addition, the device and methods may also be used to treat aneurysms. The device may also be used to treat hypertension, and to function as a blood pressure regulator.

What is claimed is:  
     
         1 . A method of treating cardiac arrhythmias comprising: 
 delivering a treatment device to a target site;    manipulating said device to conform a shape of said device to a shape of said target site;    modifying a tissue makeup at the target site;    allowing said modification of tissue makeup to proceed so as to induce a response that results in electrically decoupling said tissue; and    leaving said treatment device implanted at said target site.    
     
     
         2 . A method as set forth in  claim 1 , wherein delivering a treatment device to a target site includes delivering said device to a body cavity.  
     
     
         3 . A method as set forth in  claim 2 , wherein delivering a treatment device to a target site includes delivering said device to a pulmonary vein.  
     
     
         4 . A method as set forth in  claim 3 , wherein delivering a treatment device to a target site includes delivering a stent to said pulmonary vein.  
     
     
         5 . A method as set forth in  claim 2 , wherein delivering a treatment device to a target site includes delivering said device to an ostium of a pulmonary vein.  
     
     
         6 . A method as set forth in  claim 5 , wherein delivering a treatment device to a target site includes delivering a stent to said ostium of said pulmonary vein.  
     
     
         7 . A method as set forth in  claim 6 , wherein manipulating said device further conforms said target site to said shape of said device, bringing said ostium into a lumen of said device.  
     
     
         8 . A method as set forth in  claim 2 , wherein delivering a treatment device to a target site includes delivering said device to a left atrium.  
     
     
         9 . A method as set forth in  claim 8 , wherein delivering a treatment device to a target site includes delivering a stent to said left atrium.  
     
     
         10 . A method as set forth in  claim 1 , wherein modifying the tissue makeup is performed by stretching said tissue.  
     
     
         11 . A method as set forth in  claim 10 , wherein stretching said tissue does not produce tissue laceration.  
     
     
         12 . A method as set forth in  claim 10 , wherein stretching said tissue induces tissue laceration.  
     
     
         13 . A method as set forth in  claim 10 , wherein stretching said tissue induces organ ischemia.  
     
     
         14 . A method as set forth in  claim 10  wherein stretching said tissue induces fibrosis.  
     
     
         15 . A method as set forth in  claim 1 , wherein modifying the tissue makeup includes mechanically impairing at least a portion of said tissue.  
     
     
         16 . A method as set forth in  claim 15 , wherein mechanically impairing said tissue includes penetrating said tissue with pointed structures fixed on said treatment device.  
     
     
         17 . A method as set forth in  claim 1 , wherein modifying the tissue makeup includes mechanically changing at least a portion of said tissue.  
     
     
         18 . A method as set forth in  claim 17 , wherein mechanically changing at least a portion of said tissue includes distorting a geometry of an ostium such that atrial cells at an ostial site are repositioned within a lumen of said device.  
     
     
         19 . A method as set forth in  claim 1 , wherein disrupting the tissue make-up includes introducing a bioactive agent to said target site.  
     
     
         20 . A method as set forth in  claim 19 , wherein said bioactive agent comprises a metallic coating.  
     
     
         21 . A method as set forth in  claim 1 , wherein more than one treatment device is delivered to more than one target site.  
     
     
         22 . A method as set forth in  claim 21 , wherein said target site is selected from the group consisting of right pulmonary venous ostium, left pulmonary venous ostium, right pulmonary arterial ostium, left pulmonary arterial ostium, right pulmonary vein, left pulmonary vein, right pulmonary artery, left pulmonary artery, coronary sinus, atrial tissue and any combination thereof.  
     
     
         23 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing inflammation.  
     
     
         24 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing fibrosis.  
     
     
         25 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing elastance caused by elastin synthesis.  
     
     
         26 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing calcification of said tissue.  
     
     
         27 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing cell proliferation.  
     
     
         28 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing collagen formation.  
     
     
         29 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes inducing extra-cellular changes.  
     
     
         30 . A method as set forth in  claim 1 , wherein modifying said tissue makeup at the target site includes introducing a therapeutic drug.  
     
     
         31 . A device for modifying conduction, electrical connection and propagation properties in a tissue comprising: 
 a structural platform made of a biocompatible material;    said platform conformable to a shape of a target tissue site;    said platform having a treatment component sized and shaped to induce a fibrotic response in said target tissue; and,    said treatment component being configured to cause sufficient fibrotic response so as to substantially eliminate said cardiac arrhythmias.    
     
     
         32 . A device according to  claim 31 , wherein said platform presses against said target tissue to leave at most a minimal gap.  
     
     
         33 . A device according to  claim 31 , wherein said structural platform is an implantable pulmonary vein support structure.  
     
     
         34 . A device according to  claim 33 , wherein said treatment component includes pointed structures fixed on an external surface of said pulmonary vein support structure.  
     
     
         35 . A device according to  claim 33 , wherein said structural platform is a pulmonary vein stent.  
     
     
         36 . A device according to  claim 33 , wherein said structural platform is a coronary sinus stent.  
     
     
         37 . A device according to  claim 33 , wherein said structural platform is a cardiac vein stent.  
     
     
         38 . A device according to  claim 33 , wherein said structural platform is an arterial tissue stent.  
     
     
         39 . A device according to  claim 33 , wherein said structural platform is a pulmonary artery stent.  
     
     
         40 . A device according to  claim 31 , wherein said structural platform is an implantable coronary sinus support structure.  
     
     
         41 . A device according to  claim 31 , wherein said structural platform is an implantable cardiac vein support structure.  
     
     
         42 . A device according to  claim 31 , wherein said structural platform is an implantable arterial tissue support structure.  
     
     
         43 . A device according to  claim 31 , wherein said structural platform is an implantable pulmonary artery support structure.  
     
     
         44 . A device according to  claim 31 , wherein said structural platform is conformable to substantially an internal shape of a pulmonary vein.  
     
     
         45 . A device according to  claim 31 , wherein said treatment component includes a therapeutic substance.  
     
     
         46 . A device according to  claim 45 , wherein said treatment component includes a plurality of pointed structures.  
     
     
         47 . A device for modifying tissue at a target tissue site of an organ comprising: 
 at least one deployment platform;    said deployment platform including a treatment component configured to induce a material tissue response at said target tissue site; and    said treatment component configured to induce a material tissue response sufficient to modify local physiologic properties of said organ so as to achieve a desired therapeutic goal for said organ.    
     
     
         48 . A device according to  claim 47 , wherein said organ includes a heart and associated cardiopulmonary vessels.  
     
     
         49 . A device according to  claim 48 , wherein said tissue site includes tissue associated with a pulmonary vein.  
     
     
         50 . A device according to  claim 49 , wherein said tissue includes tissue comprising a pulmonary ostium.  
     
     
         51 . A device according to  claim 48 , wherein said therapeutic goal is the electrical decoupling of said target tissue.  
     
     
         52 . A device according to  claim 47 , wherein said organ includes an abdominal aorta.  
     
     
         53 . A device according to  claim 52 , wherein said therapeutic goal comprises an increase in structural integrity of said organ at an aneurysm site.  
     
     
         54 . A device according to  claim 53 , wherein said material tissue response is a fibrotic response.  
     
     
         55 . A device according to  claim 52 , wherein said therapeutic goal is to increase elasticity of said tissue at said target tissue site.  
     
     
         56 . A device according to  claim 47 , wherein said deployment platform is a body lumen support structure.  
     
     
         57 . A device according to  claim 56 , wherein said body lumen support structure is a stent like structure.  
     
     
         58 . A device according to  claim 48 , wherein said body lumen support structure is sized and shaped for placement into a pulmonary vein.  
     
     
         59 . A device according to  claim 47 , wherein said body lumen support structure is sized and shaped for placement in an abdominal aorta.  
     
     
         60 . A device according to  claim 47 , wherein said deployment platform is sized and shaped for placement on an external surface of a body organ.  
     
     
         61 . A device according to  claim 60 , wherein said deployment platform is sized and shaped for placement on an external surface of a pulmonary vein.  
     
     
         62 . A device according to  claim 57 , wherein said treatment component includes mechanical barbs.  
     
     
         63 . A device according to  claim 57 , wherein said treatment component includes a chemical coating on said stent-like structure.  
     
     
         64 . A method of inducing a material tissue response at a target site comprising: 
 delivering a treatment device to said target site;    ensuring contact of a treatment component of said treatment device with tissue at said target site;    inducing said material tissue response at said target site as a result of ensuring contact of said treatment component with said tissue;    allowing said material tissue response to continue at said target site at least until a therapeutic goal is substantially achieved.    
     
     
         65 . A method according to  claim 64 , wherein a therapeutic goal of electrical decoupling of said tissue is achieved.  
     
     
         66 . A method according to  claim 65 , wherein an electrical decoupling resulting in the elimination of cardiac arrhythmias is achieved.  
     
     
         67 . A method according to  claim 66 , wherein delivering a treatment device to a target site includes delivery to a region that at least includes a pulmonary ostium.  
     
     
         68 . A method according to  claim 67 , wherein delivering said treatment device includes delivery to a region that further includes a pulmonary vein.  
     
     
         69 . A method according to  claim 64 , wherein inducing the material tissue response includes inducing fibrosis.  
     
     
         70 . A method according to  claim 64 , wherein inducing the material tissue response includes inducing elastance.  
     
     
         71 . A method according to  claim 64 , wherein a therapeutic goal of increasing structural integrity of said tissue is achieved.  
     
     
         72 . A method according to  claim 71 , wherein increasing structural integrity includes reinforcing tissue of an abdominal aorta in a region of an aneurysm.  
     
     
         73 . A method according to  claim 64 , wherein ensuring contact of a treatment component with said tissue includes ensuring contact of a drug with said tissue.  
     
     
         74 . A method according to  claim 64 , wherein ensuring contact of a treatment component includes urging mechanical barbs of said treatment device into said tissue.