Pulsed electric field waveform manipulation and use
Devices, systems and methods are provided for delivering pulsed electric field (PEF) energy to tissue through one or more energy delivery bodies, each having one or more electrodes. The PEF energy is generated from a waveform having a variety of features. Waveform delays, such as inter-pulse delays, inter-cycle delays, inter-phase delays, inter-packet delays, inter-bundle delays, may be utilized within a treatment to obtain a desired outcome. In particular, these delays may be specifically manipulated to obtain particular desired outcomes. For example, one, some or all of these delays may be manipulated to control various aspects of PEF therapy so as to mitigate any associated risks, such as gas formation, electrical discharge, cavity formation, muscle contraction, and temperature rise, to name a few. In some embodiments, the delays distribute the period over which PEF energy is delivered, resulting in marked changes and optimization to the treatment delivery outcomes.
1 . A system for treating tissue of a patient comprising:
at least one electrode positionable near the tissue; and
a generator in electrical communication with the at least one electrode, wherein the generator includes at least one energy delivery algorithm that provides pulsed electric field energy to the electrode so that the pulsed electric field energy provides a treatment to the tissue,
wherein the pulsed electric field energy is generated from a waveform comprising at least one packet of pulses having one or more delay periods so that each packet has a duty cycle of less than or equal to 2.5 percent, which manipulates or reduces or avoids one or more secondary effects,
wherein the pulsed electric field energy causes cell death by non-thermal effects.
2 . The system of claim 1 , wherein the one or more secondary effects comprises cavity formation in the tissue.
3 . The system of claim 1 , wherein the pulses are biphasic pulses and wherein the at least one of the one or more delay periods is a cycle delay or phase delay of approximately 1,000 microseconds to 10,000 microseconds.
4 . The system of claim 1 , wherein the one or more secondary effects comprises an electrical discharge event.
5 . The system of claim 4 , wherein the electrical discharge event comprises electrical arcing from at least one of the at least one electrode.
6 . The system of claim 4 , wherein the pulses are biphasic pulses and wherein the at least one of the one or more delay periods is a cycle delay or phase delay of approximately 250 microseconds.
7 . The system of claim 4 , wherein the electrical discharge event comprises generation of a pressure wave against the tissue.
8 . The system of claim 7 , wherein the pressure wave is sufficient to generate a cavity within the tissue.
9 . The system of claim 8 , wherein each of the one or more packets of pulses has an on-time in a range of 0.5 to 20 microseconds.
10 . The system of claim 1 , wherein the one or more secondary effects comprises bubble formation.
11 . The system of claim 10 , wherein bubble formation comprises formation of bubbles greater than or equal to 0.1 mm in diameter.
12 . The system of claim 1 , wherein at least one of the one or more delay periods is in a range of 250 microseconds to 1000 microseconds.
13 . The system of claim 1 , wherein the one or more packets of pulses comprises 100 packets.
14 . The system of claim 1 , wherein each of the one or more packets has a cycle count of up to 60 cycles.
15 . The system of claim 1 , wherein the one or more secondary effects comprises a contraction of a muscle.
16 . The system of claim 15 , wherein the at least one electrode is configured to create a lesion having a width and wherein reducing or avoiding contraction of the muscle causes the at least one electrode to maintain a position that does not move more than 25% of the width.
17 . The system of claim 1 , wherein the pulses comprise biphasic pulses and the delay period comprises an inter-phase delay between a positive phase and a negative phase of a biphasic pulse.
18 . The system of claim 1 , wherein the waveform comprises one or more bundles separated by an inter-bundle delay, wherein each bundle comprises two or more packets.
19 . The system of claim 1 , further comprising a remote dispersive electrode positionable so that the pulsed electric field energy is delivered in a monopolar manner.
20 . A system for treating tissue of a patient comprising:
an energy delivery device having at least one energy delivery body having a form of a probe, wherein the probe is configured to penetrate the tissue; and
a generator in electrical communication with the at least one energy delivery body, wherein the generator includes at least one energy delivery algorithm that provides pulsed electric field energy to the energy delivery body so that the pulsed electric field energy provides a treatment to the tissue, wherein the pulsed electric field energy is generated from a waveform comprising a plurality of packets of pulses to provide the treatment and comprising one or more delay periods positioned within the waveform so that each packet has a duty cycle of less than or equal to 2.5 percent so as to reduce or avoid cavity formation around the probe in the tissue,
wherein the pulsed electric field energy causes cell death by non-thermal effects.
21 . The system of claim 20 , wherein at least one of the one or more delay periods is greater than 100 microseconds.
22 . The system of claim 20 , wherein the pulses are biphasic pulses and wherein the at least one of the one or more delay periods is a cycle delay or phase delay.
23 . A system for treating tissue of a patient comprising:
at least one electrode positionable near the tissue; and
a generator in electrical communication with the at least one electrode, wherein the generator includes at least one energy delivery algorithm that provides pulsed electric field energy to the electrode so that the pulsed electric field energy provides a treatment to the tissue,
wherein the pulsed electric field energy is generated from a waveform comprising at least one packet of pulses which causes a temperature rise spike within the tissue,
wherein each packet of pulses includes one or more delay periods so that each packet has a duty cycle of less than or equal to 2.5 percent, which affect an amplitude of the temperature rise spike in an amount sufficient to reduce or avoid an electrical discharge event,
wherein the pulsed electric field energy causes cell death by non-thermal effects.
24 . The system of claim 23 , wherein each of the one or more delay periods is 200 microseconds to 20,000 microseconds.
25 . The system of claim 23 , wherein each of the one or more delay periods is 1,000 microseconds to 10,000 microseconds.