METHODS, APPARATUSES, AND SYSTEMS FOR THE TREATMENT OF DISEASE STATES AND DISORDERS
Apparatuses, systems and methods are provided for treating pulmonary tissues via delivery of energy, generally characterized by high voltage pulses, to target tissue using a pulmonary tissue modification system (e.g., an energy delivery catheter system). Example pulmonary tissues include, without limitation, the epithelium (the goblet cells, ciliated pseudostratified columnar epithelial cells, and basal cells), lamina propria, submucosa, submucosal glands, basement membrane, smooth muscle, cartilage, nerves, pathogens resident near or within the tissue, or a combination of any of these. The system may be used to treat a variety of pulmonary diseases or disorders such as or associated with COPD (e.g., chronic bronchitis, emphysema), asthma, interstitial pulmonary fibrosis, cystic fibrosis, bronchiectasis, primary ciliary dyskinesia (PCD), acute bronchitis and/or other pulmonary diseases or disorders.
1 . A system for treating a body passageway of a patient, the system comprising:
a catheter comprising at least one electrode disposed near its distal end, wherein the distal end of the catheter is configured to be positioned within the body passageway so that the at least one electrode is able to transmit energy to a wall of the lung passageway; and
a generator in electrical communication with the at least one electrode, wherein the generator includes at least one energy delivery algorithm configured to provide an electric signal of the energy transmittable to the wall which selectively treats particular cells at least on a surface of the wall, wherein the electric signal comprises biphasic pulses, wherein at least some of the biphasic pulses are separated by a dead time so as to reduce biphasic cancellation.
2 . A system as in claim 1 , wherein the dead time is up to 100 milliseconds.
3 . A system as in claim 1 , wherein the biphasic pulses have a switch time that is shorter than the dead time.
4 . A system as in claim 1 , wherein the biphasic pulses each have a positive phase and a negative phase which are balanced.
5 . A system as in claim 4 , wherein an area under a curve of the positive phase equals an area under a curve of the negative phase.
6 . A system as in claim 4 , wherein the biphasic pulses have identical duration and voltage.
7 . A system as in claim 1 , wherein at least two of the biphasic pulses have different voltages.
8 . A system as in claim 1 , wherein at least two of the biphasic pulses have different durations.
9 . A system as in claim 1 , wherein the particular cells comprise precancerous cells or cancerous cells.
10 . A system as in claim 9 , wherein the electric signal comprises 100 packets of biphasic pulses.
11 . A system as in claim 1 , further comprising a user interface configured to allow operator-defined inputs comprising duration of energy delivery or other timing aspects of the energy delivery pulse, power, target temperature, mode of operation, or a combination of these.
12 . A system as in claim 11 , wherein mode of operation comprises system initiation and self-test, operator input, algorithm selection, pre-treatment system status and feedback, energy delivery, post energy delivery display or feedback, treatment data review and/or download, software update, or a combination of these.
13 . A system as in claim 1 , wherein the electric signal comprises a frequency and a voltage, and wherein an effect of the frequency inversely balances an effect of the voltage so as to target the particular cells.
14 . A system as in claim 1 , wherein each of the biphasic pulses has a voltage between approximately 500-4000 V.
15 . A system as in claim 1 , wherein the electric signal has a frequency in the range of approximately 100-1000 kHz.
16 . A system as in claim 1 , wherein the at least one energy delivery algorithm comprises a selectable first energy delivery algorithm that delivers energy to the at least one electrode so as to function in a monopolar fashion with a dispersive electrode and a selectable second energy delivery algorithm that delivers energy to at least two electrodes of the at least one electrode so that the at least two electrodes function in a bipolar fashion.
17 . A system as in claim 1 , wherein the at least one energy delivery algorithm switches between delivering energy to the at least one electrode so as to function in a monopolar fashion with a dispersive electrode and delivering energy to at least two electrodes of the at least one electrode so that the at least two electrodes function in a bipolar fashion.
18 . A system as in claim 17 , wherein switching is configured to achieve a desired treatment area and/or depth of treatment.
19 . A system as in claim 1 , wherein the at least one energy delivery algorithm delivers energy to the at least one electrode in a multiplexed fashion.
20 . A system as in claim 19 , wherein the multiplexed fashion comprises cycling delivery of energy through any pair of two electrodes of the at least one electrode wherein one of each pair of the two electrodes is neutral.