Methods, apparatuses, and systems for the treatment of pulmonary 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 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 wall of a lung passageway of a patient comprising:
a catheter comprising at least one electrode disposed near its distal end, wherein the at least one electrode is configured to be positioned within a lumen of the lung passageway so that the at least one electrode is able to transmit energy toward the 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 to the at least one electrode causing the energy to be transmitted to a targeted cell depth not extending beyond a basement membrane of the wall from the at least one electrode for a treatment duration so as to provide a treatment of a condition of the lung passageway, wherein the electric signal comprises distinct energy packets wherein each energy packet comprises a series of biphasic pulses.
2. A system as in claim 1 , wherein the energy is below a threshold for thermal ablation of the wall of the lung passageway throughout the duration of treatment.
3. A system as in claim 1 , wherein each distinct packet has a cycle count of up to 60 biphasic pulses.
4. A system as in claim 1 , wherein each distinct energy packet has a duration of up to 100 microseconds.
5. A system as in claim 4 , wherein the electric signal comprises five distinct energy packets and wherein each energy packet has a duration of 100 microseconds.
6. A system as in claim 1 , wherein the treatment comprises selectively removing or killing cells of the wall of the lung passageway associated with the condition.
7. A system as in claim 1 , wherein the treatment comprises selectively modifying cells of the wall of the lung passageway associated with the condition.
8. A system as in claim 1 , wherein the treatment selectively targets endothelial cells, pseudostratified columnar epithelial cells, goblet cells, and/or basal cells.
9. A system as in claim 1 , wherein the at least one energy delivery algorithm is configured to provide an electric signal to the at least one electrode causing the energy to be transmitted from the at least one electrode toward and not beyond an epithelial layer.
10. A system as in claim 1 , further comprising a return electrode wherein the system is configured to provide the electric signal of the energy to the patient in a monopolar fashion with the use of the return electrode.
11. A system as in claim 10 , wherein each pulse of the series of biphasic pulses is between approximately 1000-2500 volts.
12. A system as in claim 1 , wherein the at least one electrode comprises at least one bipolar electrode pair and wherein the generator is in electrical communication with the at least one bipolar electrode pair so as to provide the electric signal to the at least one bipolar electrode pair causing the energy to be transmitted to the wall of the lung passageway in a bipolar fashion.
13. A system as in claim 12 , wherein each pulse of the series of biphasic pulses is between approximately 100-1900 volts.
14. A system as in claim 1 , wherein at least one of the at least one electrode comprises a plurality of wires forming an expandable basket configured to expand within the lung passageway.
15. A system as in claim 1 , wherein at least one of the at least one electrode comprises an energy delivery body having a plurality of separate active areas which are each insulated from each other.
16. A system as in claim 1 , wherein the at least one of the at least one electrode comprises an energy delivery body having an active area isolated from a remainder of the energy delivery body.
17. A system as in claim 1 , wherein the generator comprises a processor in communication with at least one sensor, wherein the processor modifies at least one of the at least one energy delivery algorithm based on data from the at least one sensor.
18. A system as in claim 2 , wherein the threshold for thermal ablation is 65 degrees Celsius.
19. A system as in claim 1 , wherein the at least one energy delivery algorithm is configured to provide an electric signal to the at least one electrode causing the energy to be transmitted from the at least one electrode to a mucus layer.
20. A system as in claim 1 , wherein the treatment comprises selectively removing or killing one or more pathogens.
21. A system as in claim 1 , wherein each distinct energy packet has a frequency of 500-800 kHz.
22. A system as in claim 17 , wherein the at least one sensor comprises a temperature sensor and wherein the generator modifies at least one of the at least one energy delivery algorithm based on temperature data from the temperature sensor so as to maintain temperature at or below 65 degrees Celsius.