Methods and apparatus for inducing controlled renal neuromodulation
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Abstract
Methods and apparatus are provided for inducing, monitoring and controlling renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. In some embodiments, tissue impedance, conductance or conductivity may be monitored to determine the effects of pulsed electric field therapy, e.g., to determine an extent of electroporation and its degree of irreversibility. Pulsed electric field electroporation of tissue causes a decrease in tissue impedance and an increase in tissue conductivity. If induced electroporation is reversible, upon cessation of the pulsed electric field, tissue impedance and conductivity should approximate baseline levels; however, if electroporation is irreversible, impedance and conductivity changes should persist. Thus, monitoring of impedance or conductivity may be utilized to determine the onset of electroporation and to determine the type or extent of electroporation. Furthermore, monitoring data may be used in one or more manual or automatic feedback loops to control the electroporation.
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Citations
85 Claims
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1-52. -52. (canceled)
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53. An apparatus for generating a pulsed electric field waveform for inducing controlled renal neuromodulation, comprising:
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a pulse generator; and
a controller including a medium containing instructions that cause the pulse generator to generate a first electric pulse at a first energy insufficient to induce irreversible electroporation and/or electrofusion, and a second electric pulse at a second energy sufficient to induce irreversible electroporation and/or electrofusion in a neural fiber that contributes to renal function of a patient. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68)
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69. A method for inducing controlled renal neuromodulation, the method comprising:
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positioning at least one electrode proximate to a neural fiber that contributes to renal function of a patient, the neural fiber having a threshold beyond which electroporation is irreversible and/or electrofusion occurs; and
delivering a pulsed electric field via the electrode to modulate the neural fiber, wherein the pulsed electric field comprises a first electric pulse with a first energy below the threshold, and a second electric pulse with a second energy above the threshold. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80)
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81. An apparatus for generating a pulsed electric field waveform for inducing controlled renal neuromodulation, comprising:
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a pulse generator; and
a controller including a medium containing instructions that cause the pulse generator to generate a pulsed electric field waveform having waveform parameters configured to induce irreversible electroporation and/or electrofusion in a neural fiber that contributes to renal function of a patient when the waveform is delivered within vasculature of the patient, wherein at least one of the waveform parameters is determined based on a diameter of the vasculature in which the pulsed electric field waveform is delivered. - View Dependent Claims (82, 83, 84)
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85. An apparatus for generating a pulsed electric field for controlling neuromodulation in a neural fiber that contributes to renal function, the neural fiber having a threshold beyond which electroporation is irreversible and/or electrofusion occurs, comprising:
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a pulsed field generator; and
a control system operatively coupled to the pulsed field generator, the control system including a medium containing instructions that cause the pulsed field generator to generate a first pulse at an energy below the threshold and a second pulse at an energy above the threshold.
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Specification