Probe assembly for mapping and ablating pulmonary vein tissue and method of using same

Abstract

The present invention relates to a probe assembly for mapping and ablating pulmonary vein tissue and method of using the same. The probe assembly includes an expandable and collapsible basket assembly having multiple splines. One or more of the splines carry one or more electrodes adapted to sense electrical activity in the pulmonary vein tissue. The basket assembly defines an interior, and a microporous expandable and collapsible body is disposed in the interior of the basket assembly and defines an interior adapted to receive a medium containing ions. An internal electrode is disposed within the interior of the body and is adapted to transmit electrical energy to the medium containing ions. The body includes at least one microporous region having a plurality of micropores therein sized to passions contained in the medium without substantial medium perfusion therethrough, enabling ionic transport of electrical energy from the internal electrode, through ion-containing medium to an exterior of the body to ablate pulmonary vein tissue. In other aspects of the invention, the microporous body may be replaced by a non-porous expandable and collapsible body that receives a fluid medium for expanding the nonporous body to exclude blood from the electrodes on the splines, or the probe assembly may not include any expandable and collapsible body in the basket assembly interior (one or more electrodes on splines sense electrical activity in the pulmonary vein tissue and ablate the pulmonary vein tissue).

We claim:  
     
         1 . A probe assembly for mapping and ablating pulmonary vein tissue, comprising an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue, said basket assembly defining an interior; and 
 an expandable and collapsible body disposed in the interior of said basket assembly and defining an interior adapted to receive a fluid medium for expanding said expandable and collapsible body.    
     
     
         2 . The assembly of  claim 1 , wherein said expandable and collapsible body is a microporous expandable and collapsible body defining an interior adapted to receive a medium containing ions, an internal electrode disposed within said interior of said body and adapted to transmit electrical energy to said medium containing ions, said body including at least one microporous region having a plurality of micropores therein sized to pass ions contained in the medium without substantial medium perfusion therethrough, to thereby enable ionic transport of electrical energy from the internal electrode, through the ion-containing medium to an exterior of the body to ablate pulmonary vein tissue.  
     
     
         3 . The assembly of  claim 2 , wherein the body is made of a poly(vinylidene fluoride) and poly(vinylpyrrolidone) combination.  
     
     
         4 . The assembly of  claim 2 , wherein said body includes at least one customized microporous region with a predetermined geometry to more efficiently produce a desired lesion characteristics.  
     
     
         5 . The assembly of  claim 2 , wherein said body is adapted to extend between and beyond the circumferential region defined by said basket assembly when said basket assembly and said body are in an expanded state.  
     
     
         6 . The assembly of  claim 2 , wherein said body when expanded is sized to create a circumferential lesion in the pulmonary vein or around the ostium.  
     
     
         7 . The assembly of  claim 2 , wherein said body when expanded is smaller in size than the vein orifice so as to allow blood flow thereby, and said body is adapted to sectionally ablate the pulmonary vein or vein ostium.  
     
     
         8 . The assembly of  claim 2 , wherein said microporous body is integrated with said basket assembly.  
     
     
         9 . The assembly of  claim 2 , wherein said microporous body is removable from said basket assembly.  
     
     
         10 . The assembly  2 , wherein said microporous body and basket assembly are separately steerable.  
     
     
         11 . The assembly of  claim 2 , wherein said one or more electrodes are adapted to also ablate pulmonary vein tissue.  
     
     
         12 . The assembly of  claim 11 , wherein said microporous body when expanded is adapted to exclude blood from said electrodes.  
     
     
         13 . The assembly of  claim 2 , wherein said microporous body is adapted to be maintained in an expanded condition at a substantially constant pressure by a continuous flow of said medium therethrough, providing a cooling effect in said microporous body and pulmonary vein tissue.  
     
     
         14 . The assembly of  claim 13 , further including an inlet lumen adapted to continuously deliver said medium to said microporous body and an outlet lumen adapted to continuously withdraw said medium from said microporous body.  
     
     
         15 . The assembly of  claim 1 , wherein said body is a non-porous expandable and collapsible body.  
     
     
         16 . The assembly of  claim 15 , wherein said one or more electrodes are adapted to also ablate pulmonary vein tissue.  
     
     
         17 . The assembly of  claim 16 , wherein said microporous body when expanded is adapted to exclude blood from said electrodes.  
     
     
         18 . The assembly of  claim 15 , wherein said non-porous expandable and collapsible body is adapted to be maintained in an expanded condition at a substantially constant pressure by a continuous flow of said medium therethrough, providing a cooling effect in said microporous body and pulmonary vein tissue.  
     
     
         19 . The assembly of  claim 18 , further including an inlet lumen adapted to continuously deliver said medium to said microporous body and an outlet lumen adapted to continuously withdraw said medium from said microporous body.  
     
     
         20 . The assembly of  claim 1 , wherein said expandable and collapsible body includes an interior adapted to receive a cryogenic medium to thereby enable cryogenic ablation of pulmonary vein tissue via said cryogenic medium and said body.  
     
     
         21 . The assembly of  claim 1 , wherein said probe assembly includes a drug delivery mechanism adapted to deliver one or more drugs to pulmonary vein tissue or adjacent tissue.  
     
     
         22 . A probe assembly for mapping and ablating pulmonary vein tissue, comprising an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes, at least one of said one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue and ablate said pulmonary vein tissue.  
     
     
         23 . The probe assembly of  claim 22 , wherein each of said one or more electrodes at least partially surround a temperature sensor.  
     
     
         24 . A probe assembly for mapping and ablating pulmonary vein tissue, comprising an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes, at least one of said one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue, and said probe assembly further including an ablating element adapted to ablate said pulmonary vein tissue.  
     
     
         25 . The assembly of  claim 24 , wherein said ablating element is an electrode adapted to ablate pulmonary vein tissue by the transmission of RF energy through the pulmonary vein tissue.  
     
     
         26 . The assembly of  claim 24 , wherein the probe assembly includes a body having an interior adapted to receive a cryogenic medium to thereby enable cryogenic ablation of pulmonary vein tissue via said cryogenic medium and said body.  
     
     
         27 . The assembly of  claim 24 , wherein said probe assembly includes a laser adapted to deliver laser light to ablate pulmonary vein tissue.  
     
     
         28 . The assembly of  claim 24 , wherein said probe assembly includes an ultrasound transmitter adapted to deliver ultrasonic energy to ablate pulmonary vein tissue.  
     
     
         29 . The assembly of  claim 24 , wherein said probe assembly includes a drug delivery mechanism adapted to deliver one or more drugs to pulmonary vein tissue or adjacent tissue.  
     
     
         30 . A method of mapping and ablating pulmonary vein tissue, comprising: 
 providing an integrated probe assembly in a target region of a pulmonary vein, the integrated probe assembly including: 
 an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue and transmit electrical energy to ablate the pulmonary vein tissue;  
 expanding said basket assembly of said probe assembly so that one or more of said electrodes contact said pulmonary vein tissue;  
 mapping electrical activity in said pulmonary vein tissue with said one or more electrodes; and  
 without removing the basket assembly and one or more electrodes, ablating one or more targeted regions of pulmonary vein tissue determined by said mapping step by transmitting electrical energy to the electrodes, ablating the pulmonary vein tissue.  
   
     
     
         31 . The method of  claim 30 , further comprising rotating the probe assembly one or more times and ablating the pulmonary vein tissue so that a contiguous lesion lesion is created in the pulmonary vein tissue.  
     
     
         32 . The method of  claim 30 , wherein the basket assembly includes an interior, a microporous expandable and collapsible body located in said interior, said microporous expandable and collapsible body defining an interior adapted to receive a medium containing ions, an internal electrode disposed within said interior of said body and adapted to transmit electrical energy to said medium containing ions, said body including at least one microporous region having a plurality of micropores therein sized to pass ions contained in the medium without substantial medium perfusion therethrough, to thereby enable ionic transport of electrical energy from the internal electrode, through the ion-containing medium to an exterior of the body to ablate pulmonary vein tissue, the method further including expanding the microporous porous expandable and collapsible body and excluding blood from said electrodes, and ablating one or more targeted regions of pulmonary vein tissue by ionic transport of electrical energy from the internal electrode, through the ionic-containing medium, and into the pulmonary vein tissue.  
     
     
         33 . The method of  claim 30 , wherein the basket assembly includes an interior, a non-porous expandable and collapsible body located in said interior, the method further including expanding the non-porous expandable and collapsible body and excluding blood from said electrodes.  
     
     
         34 . A method of mapping and ablating pulmonary vein tissue, comprising: 
 providing a probe assembly in a target region of a pulmonary vein, the probe assembly including: 
 an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue, said basket assembly defining an interior; and  
 a microporous expandable and collapsible body defining an interior adapted to receive a medium containing ions, an internal electrode disposed within said interior of said body and adapted to transmit electrical energy to said medium containing ions, said body including at least one microporous region having a plurality of micropores therein sized to pass ions contained in the medium without substantial medium perfusion therethrough, to thereby enable ionic transport of electrical energy from the internal electrode, through the ion-containing medium to an exterior of the body to ablate pulmonary vein tissue  
 expanding said basket assembly of said probe assembly so that one or more of said mapping electrodes contact said pulmonary vein tissue;  
 mapping electrical activity in said pulmonary vein tissue with said one or more electrodes; and  
 without removing the basket assembly and one or more electrodes, ablating one or more targeted regions of pulmonary vein tissue determined by said mapping step by ionic transport of electrical energy from the internal electrode, through the ionic-containing medium, and into the pulmonary vein tissue.  
   
     
     
         35 . The method of  claim 34 , wherein said body is adapted to extend between and beyond the circumferential region defined by said basket assembly when said basket assembly and said body are in an expanded state, and the method further including ablating said pulmonary vein tissue with a microporous portion of said body extending between and beyond the circumferential region defined by said basket assembly.  
     
     
         36 . The method of  claim 34 , further including expanding said body and ablating said tissue to create a circumferential lesion in the pulmonary vein or around the ostium.  
     
     
         37 . The method of  claim 34 , further including expanding said body to a size smaller than the vein orifice so as to allow blood flow thereby, and ablating one or more sectors of the pulmonary vein or vein ostium.  
     
     
         38 . The method of  claim 34 , wherein providing a probe assembly in a target region of a pulmonary vein includes providing an integrated microporous body and basket assembly simultaneously in a target region of a pulmonary vein.  
     
     
         39 . The method of  claim 34 , wherein providing a probe assembly in a target region of a pulmonary vein includes providing a basket assembly in a target region of a pulmonary vein, and separately introducing the microporous body in the basket assembly.  
     
     
         40 . The method of  claim 34 , further including separately steering said microporous body and basket assembly to a target region of a pulmonary vein.  
     
     
         41 . The method of  claim 34 , further including ablating said pulmonary vein tissue with said one or more electrodes.  
     
     
         42 . The method of  claim 34 , further including expanding said microporous body and excluding blood from said electrodes.  
     
     
         43 . The method of  claim 34 , further including constantly circulating said medium through said microporous body so as to maintain said microporous body in an expanded condition at a substantially constant pressure.  
     
     
         44 . The method of  claim 43 , wherein said probe assembly includes an inlet lumen for supplying the medium to the microporous body and an outlet lumen to withdraw the medium from the microporous body.  
     
     
         45 . The method of  claim 44 , further including applying a vacuum pressure to said outlet lumen.  
     
     
         46 . The method of  claim 44 , wherein said inlet lumen includes a pressure control valve adapted to release pressure in said inlet lumen when the pressure exceeds a predetermined pressure limit.  
     
     
         47 . A method of mapping and ablating pulmonary vein tissue, comprising: 
 providing an integrated probe assembly in a target region of a pulmonary vein, the integrated probe assembly including: 
 an expandable and collapsible basket assembly including multiple splines, one or more of said splines carrying one or more electrodes adapted to sense electrical activity in said pulmonary vein tissue;  
 expanding said basket assembly of said probe assembly so that one or more of said electrodes contact said pulmonary vein tissue;  
 mapping electrical activity in said pulmonary vein tissue with said one or more electrodes; and  
 without removing the basket assembly and one or more electrodes, ablating one or more targeted regions of pulmonary vein tissue determined by said mapping step with an ablating element.  
   
     
     
         48 . The method of  claim 47 , wherein said ablating element is an electrode and ablating one or more targeted regions of pulmonary vein tissue includes ablating pulmonary vein tissue by the transmission of RF energy through the pulmonary vein tissue.  
     
     
         49 . The method of  claim 47 , wherein said ablating element is an electrode body having an interior adapted to receive a cryogenic medium and ablating one or more targeted regions of pulmonary vein tissue includes cryogenically ablating pulmonary vein tissue via said cryogenic medium and said body.  
     
     
         50 . The method of  claim 47 , wherein said ablating element is a laser and ablating one or more targeted regions of pulmonary vein tissue includes delivering laser light to the pulmonary vein tissue to ablate the pulmonary vein tissue.  
     
     
         51 . The method of  claim 47 , wherein said ablating element is an ultrasound transmitter and ablating one or more targeted regions includes delivering ultrasonic energy to the pulmonary vein tissue to ablate the pulmonary vein tissue.  
     
     
         52 . The method of  claim 47 , further including the step delivering one or more drugs to pulmonary vein tissue or adjacent tissue with a drug delivery mechanism.