Controlled neuromodulation systems and methods of use

Abstract

The present disclosure relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient. Before, during and/or after therapeutic energy delivery, a system can monitor parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at the treatment site. Feedback provided to an operator is based on the monitored values and relates to a relative position of the treatment device at the treatment site, as well as assessment of the likelihood that a completed treatment was technically successful.

I/We claim: 
     
         1 . A system, comprising:
 an elongated shaft including a distal portion and being configured to locate the distal portion within or at least proximate to a lumen of a human;   a treatment assembly coupled to the elongated shaft and including:
 a neuromodulation element configured to deliver a therapeutic energy, and 
 one or more transducers configured to emit diagnostic energy toward tissue of the lumen and detect a return energy associated with the diagnostic energy; 
 an indicator configured to notify a user of a position of the treatment assembly; and 
   a controller operably coupled to the one or more transducers and being configured to:
 determine whether the treatment assembly is within a relative distance of a wall of the lumen, and 
 cause the indicator to notify the user to reposition the treatment assembly or to begin energy delivery based on the relative distance. 
   
     
     
         2 . The system of  claim 1 , wherein the one or more transducers include an emitter that emits the diagnostic energy and a detector that detects the return energy associated with the diagnostic energy. 
     
     
         3 . The system of  claim 2 , wherein the controller is configured to:
 determine a detection time that is based on a difference in time between when the diagnostic energy is emitted and the return energy is detected; and   compare the detection time to a baseline detection time.   
     
     
         4 . The system of  claim 3 , wherein the controller is configured to determine whether the treatment assembly is within the relative distance of the wall of the lumen based on the comparison. 
     
     
         5 . The system of  claim 3 , wherein to cause the indicator to notify the user to reposition the treatment assembly or to begin energy delivery based on the relative distance the controller is configured to:
 cause the indicator to notify the user that there is sufficient contact with the wall of the lumen and to begin energy delivery when the detection time is within a pre-determined range; and   cause the indicator to notify the user there is insufficient contact with the wall of the lumen and to reposition the treatment assembly when the detection time is not within the pre-determine range.   
     
     
         6 . The system of  claim 1 , wherein the emitted diagnostic energy is ultrasound energy. 
     
     
         7 . The system of  claim 1 , wherein the controller is configured to determine whether the treatment assembly is within the relative distance of the wall of the lumen based on one or more parameters of the detected return energy. 
     
     
         8 . The system of  claim 7 , wherein the one or more parameters of the detected return energy includes a detection time or a signal amplitude of the detected return energy. 
     
     
         9 . A system, comprising:
 an elongated shaft including a distal portion and being configured to locate the distal portion within or at least proximate to a lumen of a human;   a treatment assembly coupled to the elongated shaft and including:
 a neuromodulation element configured to deliver a therapeutic energy, 
 an emitter configured to emit diagnostic energy toward tissue of the lumen, and 
 a detector configured to detect a return energy associated with the diagnostic energy; 
   an indicator that is configured to notify a user of a position of the treatment assembly; and   a controller operably coupled to the emitter and the detector and being configured to:
 determine a wall proximity of a portion of the treatment assembly to a wall of the lumen, and 
 cause the indicator to notify a user to reposition the treatment assembly or to begin energy delivery based on the wall proximity. 
   
     
     
         10 . The system of  claim 9 , wherein the controller is configured to determine the wall proximity of the portion of the treatment assembly to the wall of the lumen based on one or more parameters of the detected return energy that includes at least one of a detection time or an amplitude. 
     
     
         11 . The system of  claim 9 , wherein the controller is configured to:
 determine a detection time that is based on a difference in time between when the diagnostic energy is emitted and when the return energy is detected; and   compare the detection time to a baseline detection time.   
     
     
         12 . The system of  claim 11 , wherein the controller is configured to determine the wall proximity of the portion of the treatment assembly to the wall of the lumen based on the comparison. 
     
     
         13 . The system of  claim 9 , wherein the emitted diagnostic energy is ultrasound energy. 
     
     
         14 . The system of  claim 9 , wherein the neuromodulation element includes an array having a plurality of ablation electrodes and the indicator includes a user interface. 
     
     
         15 . A system, comprising:
 an elongated shaft including a distal portion and being configured to locate the distal portion within or at least proximate to tissue of a vessel of a human;   a treatment assembly carried by the distal portion of the elongated shaft and including:
 a neuromodulation element configured to modulate nerves associated with sympathetic neural function, 
 an emitter configured to produce a first diagnostic emission toward the tissue and a second diagnostic emission toward the tissue, and 
 a detector configured to detect a parameter of return energy of the emitted energy; 
   an indicator; and   a controller operably connected to the emitter, the detector and the indicator and being configured to:
 detect a first parameter of the return energy associated with the first diagnostic emission, 
 detect a second parameter of the return energy associated with the second diagnostic emission, 
 determine a status of the modulation of the nerves associated with sympathetic neural function based on the first parameter and the second parameter, and 
 cause the indicator to indicate a status of the modulation of the nerves. 
   
     
     
         16 . The system of  claim 15 , wherein the first parameter of the return energy includes at least one of a first detection time of return energy, a first amplitude, or a first frequency and the second parameter includes at least one of a second detection time of return energy, a second amplitude, or a second frequency. 
     
     
         17 . The system of  claim 16 , wherein the controller is configured to:
 determine a tissue characteristic based on a difference between the first parameter of the returned energy and the second parameter of the returned energy.   
     
     
         18 . The system of  claim 17 , wherein the tissue characteristic is at least one of a depth of a lesion, a temperature of the tissue or a degree of tissue damage. 
     
     
         19 . The system of  claim 17 , wherein the first energy emission and the second energy emission includes an emission of ultrasound energy or electromagnetic energy. 
     
     
         20 . The system of claim of  claim 15 , wherein the controller is configured to use the first parameter of the return energy to determine a relative position of at least a portion of the treatment assembly including an absolute radial distance between the portion of the treatment assembly and the vessel.