Helically shaped electrophysiology catheter

Abstract

An electrophysiology (EP) device suitable for ablating tissue within a patient's body lumen. The EP device of the invention generally comprises an elongated shaft having a distal shaft section with a helical shape and at least one electrode on an exterior portion thereof. One aspect of the invention comprises a method of performing a medical procedure, such as treating a patient for atrial arrhythmia, by forming a lesion using an EP device embodying features of the invention.

1 . An electrophysiology device for ablating tissue in a patient's body, comprising: 
 a) an elongated shaft having a proximal end, a distal end, and a distal shaft section with a helically shaped proximal portion which has one or more turns and which has a longitudinal axis; and a straight distal portion which extends distally from the helically shaped proximal portion of the distal shaft section and which has a longitudinal axis parallel to and off-set from the longitudinal axis of the helically shaped proximal portion    b) at least one ablation electrode on the helically shaped proximal portion of the distal shaft section.    
   
   
       2 . The device of  claim 1  wherein the turns of the helically shaped proximal portion of the distal shaft section have a diameter substantially equal to or greater than a diameter of an ostium of a body lumen.  
   
   
       3 . The device of  claim 1  wherein the helically shaped proximal portion of the distal shaft section has at least one and one quarter turns having substantially equal diameters.  
   
   
       4 . The device of  claim 1  wherein the distal shaft section has a core member which extends through at least a part of the helically shaped proximal portion and at least part of the straight portion.  
   
   
       5 . The device of  claim 4  wherein the core member in the distal section has a helical shape.  
   
   
       6 . The device of  claim 4  wherein the core member is formed at least in part of a NiTi alloy.  
   
   
       7 . The device of  claim 4  wherein the shaft has a lumen extending therein configured to slidably receive the core member.  
   
   
       8 . The device of  claim 1  including a plurality of sensing and pacing electrodes on the distal shaft section.  
   
   
       9 . (Cancelled)  
   
   
       10 . (Cancelled)  
   
   
       11 . The device of  claim 1  wherein the straight distal portion has a flexible coiled tip extending from the distal end thereof.  
   
   
       12 .- 15 . (Cancelled)  
   
   
       16 . The device of  claim 1  wherein the straight distal portion has at least two sensing electrodes.  
   
   
       17 . The device of  claim 1  wherein the straight distal portion has at least two sensing.  
   
   
       18 . (Cancelled)  
   
   
       19 . The device of  claim 1  wherein the straight distal portion has a length of about 2 to about 8 cm.  
   
   
       20 . The device of  claim 1  wherein the helical proximal portion has a length of about 0.5 to about 1 cm.  
   
   
       21 . The device of  claim 1  wherein the helical proximal portion has a circumference of about 5 to about 40 mm.  
   
   
       22 . (Cancelled)  
   
   
       23 . A method of performing a medical procedure, comprising: 
 a) providing an electrophysiology device, comprising 
 an elongated shaft having a proximal end, a distal end, and a distal shaft section having a helically shaped proximal portion having one or more turns and a straight distal portion; and  
 at least one ablation electrode on the helically shaped proximal portion; and  
   b) positioning at least part of the helically shaped proximal portion in contact with a wall defining an ostium of a patient's body lumen; and    c) delivering high frequency energy to the at least one ablation electrode to form a lesion,    
   
   
       24 . The method of  claim 23  including after (b), moving the turns of the helically shaped proximal portion closer together by distally forcing the catheter against the wall defining the ostium.  
   
   
       25 . The method of  claim 23  wherein the ostium is a junction of a pulmonary vein with a left atrium, and (c) comprises forming a plurality of discontinuous lesions around the ostium.  
   
   
       26 . The method of  claim 23  wherein the ostium is a junction of a pulmonary vein with a left atrium, and the device has at least one sensing electrode on the distal portion, and wherein the pulmonary vein is mapped by sensing electrical activity with the sensing electrode.  
   
   
       27 . The method of  claim 23  wherein delivering high frequency energy to the at least one ablation electrode forms a lesion extending at least in part around the ostium of the body lumen.  
   
   
       28 . The method of  claim 27  wherein the helically shaped proximal portion of the distal shaft section of the device Is placed In a junction between a pulmonary vein and an atrium of a patient to form a lesion to treat the patient for atrial arrhythmia.  
   
   
       29 . The method of  claim 28  wherein the device has a plurality of electrodes on the helically shaped proximal portion of the distal shaft section, and wherein a plurality of discontinuous lesions are formed at the junction between the pulmonary vein and an atrium to treat the patient for atrial arrhythmia.  
   
   
       30 . (Cancelled)  
   
   
       31 . The method of  claim 28  wherein the device has a plurality of electrodes on the helically shaped proximal portion of the distal shaft section, and including after (c), moving the turns of the helically shaped proximal portion closer together and delivering high frequency energy to at least one electrode on the helically shaped proximal portion to form a second lesion continuous with the first lesion.  
   
   
       32 . The method of  claim 28  wherein the helically shaped proximal portion has a plurality of ablation electrodes, and the straight distal portion has at least one sensing electrode, and wherein the pulmonary vein is mapped by the at least one sensing electrode sensing electrical activity.  
   
   
       33 . The device of  claim 1  wherein the straight distal portion has at least two pacing electrodes.  
   
   
       34 . The device of  claim 1 , wherein the helically shaped proximal portion has a longitudinal axis coincident with the longitudinal axis of the elongated shaft.  
   
   
       35 . The device of  claim 1 , wherein the straight distal portion of the distal shaft section has a core member which is at least in part tapered over a length thereof.  
   
   
       36 . The device of  claim 1 , wherein the straight distal portion anchors the distal shaft section.  
   
   
       37 . The device of  claim 1  wherein the core member is at least in part formed of a material selected from the group consisting of high spring-back metals, superelastic metals and shape-memory metals.  
   
   
       38 . The device of  claim 37  wherein the superelastic material is a NiTi alloy.  
   
   
       39 . An electrophysiology device for detecting electrical activity within a patients heart chamber, comprising: 
 a. an elongated shaft having a proximal end, a distal end, and a distal shaft section which is at least in part helically shaped with at least one turn and which has at least one electrode for detecting electrical activity on the helically shaped portion of the distal shaft section and which has a longitudinal axis; and    b. a straight distal portion which extends distally from the helically shaped proximal portion of the distal shaft section and which has a longitudinal axis parallel to and off-set from the longitudinal axis of the helically shaped proximal portion.    
   
   
       40 . The electrophysiology device of  claim 39  wherein the at least one electrode is about 2 to about 8 mm in length.  
   
   
       41 . An electrophysiology device for a procedure within a patient's heart chamber, comprising an elongated shaft which has a helically shaped distal shaft portion having a plurality of spaced apart electrodes and being configured to engage an ostia within the patients heart chamber.  
   
   
       42 . The electrophysiology device of  claim 40  wherein the spacing between at least two adjacent electrodes is not more than about 3 mm.  
   
   
       43 . The electrophysiology device of  claim 40  wherein the spacing between at least two adjacent electrodes is not less than about 1 mm.  
   
   
       44 . The electrophysiology device of  claim 40  wherein the distal shaft section has at least one temperature sensor.  
   
   
       45 . The electrophysiology device of  claim 44  wherein the at least one temperature sensor is disposed between two adjacent electrodes.  
   
   
       46 . The electrophysiology device of  claim 40  wherein the helically shaped distal shaft portion has at least four electrodes.  
   
   
       47 . The electrophysiology device of  claim 40  wherein the helically shaped distal shaft portion has up to about 12 electrodes.  
   
   
       48 . The electrophysiology device of  claim 40  wherein a plurality of the electrodes are ablation electrodes.  
   
   
       49 . The electrophysiology device of  claim 40  wherein a plurality of the electrodes are sensing electrodes.  
   
   
       50 . The electrophysiology device of  claim 40  wherein the elongated shaft has a straight distal shaft portion extending distally from the helically shaped distal shaft portion.  
   
   
       51 . The electrophysiology device of  claim 50  wherein the straight distal portion has a longitudinal axis parallel to and off-set from a longitudinal axis of the helically shaped distal shaft portion.  
   
   
       52 . The electrophysiology device of  claim 40  wherein the helically shaped distal shaft portion has a core member.  
   
   
       53 . The electrophysiology device of  claim 52  wherein the core member Is formed of a material selected from the group consisting of high spring-back metals, superelastIc metals and shape-memory metals.  
   
   
       54 . The electrophyslology device of  claim 53  wherein the superelastic material is a NiTi alloy.  
   
   
       55 . The electrophysiology device of  claim 41  wherein at least one of the spaced apart electrodes is about 2 to about 8 mm in length.  
   
   
       56 . An electrophysiology device for a procedure within a patient's heart chamber, comprising an elongated shaft which has an expandable distal shaft portion having a plurality of spaced apart electrodes and being configured to engage an ostia within the patients heart chamber.