Multi-electrode apposition judgment using pressure elements

Abstract

Apparatus and methods for determining positioning of a energy delivery element include deploying a energy delivery element at a treatment site proximal to a vessel wall; using a multi-region pressure sensing apparatus to sense pressures applied in a plurality of directions about the energy delivery element; and determining an orientation of the energy delivery element based on the pressures measured in the plurality of directions about the energy delivery element.

1 - 20 . (canceled) 
     
     
         21 . A method comprising:
 determining, at a first time, one or more patient metrics using an apparatus comprising:
 a therapeutic assembly configured for intravascular delivery to a treatment site; 
 a neuromodulation element disposed on the therapeutic assembly and configured to deliver neuromodulation therapy at the treatment site; and 
 a pressure sensor comprising a plurality of pressure sensitive regions, the pressure sensor being configured to generate a signal indicative of at least one of the one or more patient metrics; 
   after the neuromodulation therapy is delivered to the treatment site via the neuromodulation element, determining, at a second time that is after the first time, the one or more patient metrics;   comparing the one or more patient metrics determined at the first time to the one or more patient metrics determined at the second time; and   determining, based on the comparison, an efficacy of the neuromodulation therapy.   
     
     
         22 . The method of  claim 21 , further comprising:
 determining, based on the comparison, a level of a change of the one or more patient metrics; and   delivering, based on the level of the change being less than a change threshold level, the neuromodulation therapy.   
     
     
         23 . The method of  claim 22 , further comprising, prior to delivering the neuromodulation therapy based on the level of the change being less than a change threshold level, adjusting a parameter of the neuromodulation therapy. 
     
     
         24 . The method of  claim 22 , wherein the one or more patient metrics comprises systolic blood pressure, and wherein determining the level of the change of the one or more patient metrics comprises determining a reduction in systolic blood pressure. 
     
     
         25 . The method of  claim 22 , wherein determining the one or more patient metrics at the second time comprises determining the one or more patient metrics after a time at which the neuromodulation therapy delivery was initiated, the method further comprising:
 outputting, based on the level of the change being less than a change threshold level, a first alert; and   outputting, based on the level of the change being greater than or equal to a change threshold level, a second alert.   
     
     
         26 . The method of  claim 21 , wherein the neuromodulation therapy is delivered during a neuromodulation procedure, the method further comprising:
 determining, based on the comparison, a level of a change of the one or more patient metrics; and   concluding the neuromodulation procedure based on the level of the change being greater than or equal to a change threshold level.   
     
     
         27 . The method of  claim 26 , further comprising recording, based on the level of the change being greater than or equal to a change threshold level, the one or more patient metrics measured at the second time. 
     
     
         28 . The method of  claim 21 , wherein the one or more patient metrics comprises at least one of a blood pressure, a norepinephrine level, a tissue temperature, an impedance, or a blood flow. 
     
     
         29 . The method of  claim 21 , wherein determining the one or more patient metrics comprises monitoring blood flow, wherein the blood flow is determined based on pressure measurements from the plurality of pressure sensitive regions separated from one another by one or more known distances and positioned along an axial length of a blood vessel. 
     
     
         30 . The method of  claim 21 , further comprising delivering the neuromodulation therapy at the treatment site, wherein delivering the neuromodulation therapy comprises delivering at least one of radiofrequency energy, mechanical energy, acoustic energy, electrical energy, thermal energy, cryotherapy, or a chemical at the treatment site to ablate tissue. 
     
     
         31 . The method of  claim 21 , further comprising:
 delivering, based on the one or more patient metrics measured at the first time being greater than a predetermined threshold level, the neuromodulation therapy via the neuromodulation element; and   recording, based on the one or more patient metrics measured at the second time being less than or equal to the predetermined patient metric threshold level, the one or more patient metrics measured subsequent to delivering the neuromodulation therapy.   
     
     
         32 . A system comprising:
 a therapeutic assembly configured for intravascular delivery to a treatment site;   a neuromodulation element disposed on the therapeutic assembly and configured to deliver neuromodulation therapy at the treatment site;   a pressure sensor comprising a plurality of pressure sensitive regions, the pressure sensor being configured to generate a signal indicative of at least one patient metric of one or more patient metrics; and   processing circuitry configured to:
 determine, at a first time and based on the signal, the one or more patient metrics; 
 after the neuromodulation therapy is delivered to the treatment site via the neuromodulation element, determine, at a second time that is after the first time, the one or more patient metrics; 
 compare the one or more patient metrics determined at the first time to the one or more patient metrics determined at the second time; and 
 determine, based on the comparison, an efficacy of the neuromodulation procedure. 
   
     
     
         33 . The system of  claim 32 , wherein the processing circuitry is further configured to:
 determine, based on the comparison, a level of a change of the one or more patient metrics; and   cause the neuromodulation element to deliver the neuromodulation therapy based on the level of the change being less than a change threshold level.   
     
     
         34 . The system of  claim 33 , wherein the processing circuitry is further configured to, prior to causing the neuromodulation element to deliver the neuromodulation therapy based on the level of the change being less than the change threshold level, adjust a parameter of the neuromodulation therapy. 
     
     
         35 . The system of  claim 33 , wherein the one or more patient metrics comprises systolic blood pressure, and wherein the processing circuitry is configured to determine the level of the change of the one or more patient metrics by at least determining a reduction in systolic blood pressure. 
     
     
         36 . The system of  claim 33 , wherein determining the one or more patient metrics at the second time comprises periodically determining the one or more patient metrics after a time at which performing the neuromodulation procedure is initiated, wherein the processing circuitry is further configured to:
 output, based on the level of the change being less than a change threshold level, a first alert; and   output, based on the level of the change being greater than or equal to a change threshold level, a second alert.   
     
     
         37 . The system of  claim 32 , wherein the processing circuitry is further configured to:
 determine, based on the comparison, a level of a change of the one or more patient metrics; and   conclude, based on the level of the change being greater than or equal to a change threshold level, the neuromodulation procedure.   
     
     
         38 . The system of  claim 37 , further comprising a memory, wherein the processing circuitry is configured to, based on the level of the change being greater than or equal to a change threshold level, record the one or more patient metrics measured at the second time in the memory. 
     
     
         39 . The system of  claim 32 , wherein the one or more patient metrics comprises at least one of a blood pressure, a norepinephrine level, a tissue temperature, an impedance, or a blood flow. 
     
     
         40 . The system of  claim 32 , wherein the neuromodulation therapy comprises at least one of radiofrequency energy, mechanical energy, acoustic energy, electrical energy, thermal energy, cryotherapy, or a chemical. 
     
     
         41 . The system of  claim 32 , wherein the processing circuitry is further configured to:
 cause the neuromodulation element to deliver, based on the one or more patient metrics at the first time being greater than a predetermined threshold level, the neuromodulation therapy; and   record, based on the one or more patient metrics at the second time being less than or equal to the predetermined target threshold level, the one or more patient metrics subsequent to delivering the neuromodulation therapy.   
     
     
         42 . A system comprising:
 a therapeutic assembly configured for intravascular delivery to a treatment site;   an energy delivery element disposed on the therapeutic assembly and configured to deliver neuromodulation energy at the treatment site;   a pressure sensor comprising a plurality of pressure sensitive regions, the pressure sensor being configured to generate a signal indicative of at least one patient metric of one or more patient metrics; and   processing circuitry configured to:
 determine, at a first time, one or more patient metrics based on the signal, 
 after a neuromodulation procedure is performed, determine, at a second time that is after the first time, the one or more patient metrics, 
 compare the one or more patient metrics determined at the first time to the one or more patient metrics determined at the second time, 
 determine, based on the comparison, a level of a change of the one or more patient metrics, 
 determine the level of the change of the one or more patient metrics is greater than or equal to a threshold value, and 
 conclude the neuromodulation procedure based on determining the level of the change is greater than or equal to the threshold values.