Systems, devices, and methods for ablation using surgical clamps

Abstract

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the device including a first jaw including a plurality of first electrodes and a second jaw including a plurality of second electrodes. The first jaw and the second jaw may be substantially rigid, elongate, and collectively define a longitudinal axis. The first jaw and the second jaw may be configured to engage tissue therebetween during use.

1 . An apparatus, comprising:
 a first jaw including a first plurality of electrodes;   a second jaw including a second plurality of electrodes, the first jaw and the second jaw being substantially rigid, elongate, and collectively defining a longitudinal axis, the first jaw and the second jaw further configured to engage tissue therebetween during use,   each electrode of the first plurality of electrodes having, within a cross-section of the apparatus that is orthogonal to the longitudinal axis, a width that is less than a length of that electrode, the first plurality of electrodes spaced apart laterally with respect to the longitudinal axis,   each electrode of the second plurality of electrodes, within the cross-section, having a width that is less than a length of that electrode, the second plurality of electrodes spaced apart laterally with respect to the longitudinal axis; and   a processor operatively coupled to the first plurality of electrodes and the second plurality of electrodes, the processor configured to configure a first electrode of the first plurality of electrodes as an anode and a second electrode of the second plurality of electrodes as a cathode, the first electrode disposed diagonally across from the second electrode within the cross-section and spaced apart laterally with respect to the longitudinal axis from the second electrode,   the processor configured to deliver the pulse waveform to the first and second electrodes such that the first and second electrodes deliver ablative energy to the tissue to generate irreversible electroporation in the tissue that forms a contiguous ablation zone extending diagonally from the first electrode to the second electrode.   
     
     
         2 . The apparatus of  claim 1 , wherein the longitudinal axis has one or more of a straight portion and curved portion. 
     
     
         3 - 4 . (canceled) 
     
     
         5 . The apparatus of  claim 1 , wherein at least two electrodes of the first plurality of electrodes are spaced apart by a first measure and the first jaw and the second jaw are spaced apart by a second measure, when the tissue is engaged between the first jaw and the second jaw during use, wherein a ratio of the second measure to the first measure is between about 0.1:1 and about 12:1. 
     
     
         6 . The apparatus of  claim 1 , wherein a distance between a midpoint of at least two electrodes of the first plurality of electrodes in the cross-section orthogonal to the longitudinal axis is between about 1 mm and about 10 mm. 
     
     
         7 . The apparatus of  claim 1 , wherein any two adjacent electrodes of the first plurality of electrodes are spaced apart by a first measure of between about 0.5 mm and about 10 mm and any two adjacent electrodes of the second plurality of electrodes are spaced apart by a second measure of between about 0.5 mm and about 10 mm. 
     
     
         8 . The apparatus of  claim 1 , wherein any two adjacent electrodes of the first plurality of electrodes are spaced apart by a first measure and any two adjacent electrodes of the second plurality of electrodes are spaced apart by a second measure, wherein a ratio of the first measure to the second measure is between about 0.05:1 and about 20:1. 
     
     
         9 . The apparatus of  claim 1 , wherein any two adjacent electrodes of the first plurality of electrodes are spaced apart by a first measure and any two adjacent electrodes of the second plurality of electrodes are spaced apart by a second measure, wherein a ratio of the width of any electrode of the first plurality of electrodes to the width of any electrode of the second plurality of electrodes to the first measure is between about 0.01:1 and about 10:1. 
     
     
         10 . The apparatus of  claim 1 , wherein each electrode of the first plurality of electrodes and the second plurality of electrodes has a length of between about 10 mm and about 120 mm. 
     
     
         11 - 19 . (canceled) 
     
     
         20 . The apparatus of  claim 1 , further comprising:
 a pulse generator comprising a controller, the controller comprising the processor and a memory, the pulse generator configured to
 generate the pulse waveform, the pulse waveform having an amplitude of at least about 200 Volts. 
   
     
     
         21 . The apparatus of  claim 1 , wherein the pulse generator is further configured to:
 configure a second set of electrodes including electrodes of the first plurality of electrodes and the second plurality of electrodes for receiving electrical activity of the tissue; and   receive signal data corresponding to the electrical activity of the tissue using the second set of electrodes; and   generate electrocardiography data using the signal data.   
     
     
         22 - 26 . (canceled) 
     
     
         27 . An apparatus, comprising:
 a first jaw including a first electrode and a second electrode;   a second jaw including a third electrode and a fourth electrode, the first jaw and the second jaw being substantially rigid, elongate, and collectively defining a longitudinal axis, the first jaw and the second jaw further configured to engage tissue therebetween during use, wherein, within a cross-section of the apparatus that is orthogonal to the longitudinal axis, the first electrode is disposed diagonally across from the fourth electrode is spaced apart laterally from the fourth electrode; and   a processor operably coupled to the first jaw and the second jaw, the processor configured to, during use:
 configure the first electrode as an anode and the fourth electrode as a cathode; and 
 deliver a pulse waveform to the first electrode and the fourth electrode such that the first electrode and the fourth electrode generate a pulsed electric field that delivers ablative energy to the tissue to generate irreversible electroporation in the tissue that forms a contiguous ablation zone with greater width closer to a surface of the tissue adjacent to the first and second electrodes than at a central portion of the tissue. 
   
     
     
         28 . The apparatus of  claim 27 , wherein the longitudinal axis has one or more of a straight portion and a curved portion. 
     
     
         29 . The apparatus of  claim 27 , wherein the first electrode and the second electrode are spaced apart by a first measure of between about 0.5 mm and about 10 mm, and the third electrode and the fourth electrode are spaced apart by a second measure of between about 0.5 mm and about 10 mm. 
     
     
         30 . The apparatus of  claim 27 , wherein the first electrode and the second electrode are spaced apart by a first measure and the third electrode and the fourth electrode are spaced apart by a second measure, wherein a ratio of the first measure to the second measure is between about 0.05:1 and about 20:1. 
     
     
         31 . The apparatus of  claim 27 , wherein the first electrode and the second electrode are spaced apart by a first measure, wherein a ratio of a width of the first electrode to the first measure is between about 0.01:1 and about 10:1. 
     
     
         32 . The apparatus of  claim 27 , wherein the first, second, third, and fourth electrodes each have a length of between about 10 mm and about 120 mm. 
     
     
         33 . The apparatus of  claim 27 , wherein the first and second jaws are configured to transition between a first configuration for positioning the first and second jaws through or around a body cavity, organ system, or anatomical structure and a second configuration for engaging the tissue. 
     
     
         34 . The apparatus of  claim 33 , wherein the first and second jaws are spaced apart by a spacing distance in the second configuration. 
     
     
         35 . The apparatus of  claim 27 , wherein a cross-section of the first, second, third, and fourth electrodes are substantially rectangular. 
     
     
         36 . The apparatus of  claim 27 , wherein the first, second, third, and fourth electrodes include a curved portion. 
     
     
         37 - 41 . (canceled) 
     
     
         42 . The apparatus of  claim 27 , further comprising:
 a pulse generator coupled to the first, second, third, and fourth electrodes, the pulse generator configured to generate the pulse waveform, the pulse waveform having an amplitude of at least about 200 Volts.   
     
     
         43 . The apparatus of  claim 27 , wherein the processor is further configured to:
 configure a second set of electrodes including one or more of the first, second, third, and fourth electrodes for receiving electrical activity of the tissue;   receive signal data corresponding to the electrical activity of the tissue using the second set of electrodes; and   generate electrocardiography data using the signal data.   
     
     
         44 - 48 . (canceled) 
     
     
         49 . A method of ablating tissue via irreversible electroporation comprising:
 clamping the tissue between a first jaw and a second jaw of an apparatus, the first jaw including a first plurality of electrodes, the second jaw including a second plurality of electrodes, the first jaw and the second jaw being substantially rigid, elongate, and collectively defining a longitudinal axis,   each electrode of the first plurality of electrodes having a width orthogonal to the longitudinal axis that is less than a length parallel to the longitudinal axis of that electrode, the first plurality of electrodes spaced apart laterally with respect to the longitudinal axis,   each electrode of the second plurality of electrodes having a width orthogonal to the longitudinal axis that is less than a length parallel to the longitudinal axis of that electrode, the plurality of second electrodes spaced apart laterally with respect to the longitudinal axis;   configuring a first electrode of the first plurality of electrodes as an anode;   configuring a second electrode of the second plurality of electrodes as a cathode, the first and second electrodes, within a cross-section of the apparatus that is orthogonal to the longitudinal axis, being disposed diagonally across from one another and being spaced apart laterally from one another;   generating, using a pulse generator, a pulse waveform having an amplitude of at least 200 Volts;   delivering the pulse waveform to the first and second electrodes such that the first and second electrodes generate a pulsed electric field that causes irreversible electroporation in the tissue and generates an ablation zone that forms non-centrally in the tissue.   
     
     
         50 . (canceled) 
     
     
         51 . The method of  49 , wherein clamping the tissue comprises transitioning the first and second jaws between a first configuration for advancing the apparatus and a second configuration for clamping the tissue. 
     
     
         52 . The method of  claim 49 , wherein the tissue is a region of an atrial base of a pulmonary vein. 
     
     
         53 . The method of  claim 49 , wherein the pulse waveform includes:
 a first level of a hierarchy including a first set of pulses, each pulse of the first set of pulses having a pulse time duration and a first time interval separating successive pulses;   a second level of the hierarchy including a plurality of the first sets of pulses as a second set of pulses, a second time interval separating the second sets of pulses, the second time interval being at least three times the duration of the first time interval; and   a third level of the hierarchy including a plurality of the second sets of pulses as a third set of pulses, a third time interval separating the third sets of pulses, the third time interval being at least thirty times the duration of the second level time interval.   
     
     
         54 . The method of  49 , further comprising:
 receiving signal data corresponding to electrical activity of the tissue using one or more electrodes of the first plurality of electrodes and of the second plurality of electrodes; and   generating electrocardiography data using the signal data.   
     
     
         55 . The method of  49 , further comprising positioning the first and second jaws through or around a body cavity, organ system, or anatomical structure. 
     
     
         56 - 58 . (canceled)