Techniques for irreversible electroporation using a single-pole tine-style internal device communicating with an external surface electrode
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Publication Number
US-12303182-B2
Publication Date
2025-05-20
Expiration Date
Abstract
Techniques for High-Frequency Irreversible Electroporation (HFIRE) using a single-pole tine-style internal device communicating with an external surface electrode are described. In an embodiment, a system for ablating tissue cells in a treatment region of a patient's body by irreversible electroporation without thermally damaging the tissue cells is described. The system includes at least one single-pole electrode probe for insertion into the treatment region, the single-pole electrode probe including one or more tines. The system further includes at least one external surface electrode for placement outside the patient's body and configured to complete a circuit with the single-pole electrode probe. The system also includes a control device for controlling HFIRE pulses to the single-pole tine-style electrode and the skin-surface electrode for the delivery of electric energy to the treatment region. Other embodiments are described and claimed.
Core Innovation
The invention relates to methods and systems for ablating cells in a treatment site of a patient using high-frequency irreversible electroporation (HFIRE). A monopolar electrode is advanced through a shaft positioned within the treatment site such that the monopolar electrode does not extend distally of a distal end of the shaft, and the distal end is conductive. A surface electrode is placed on a surface of the patient and a generator is activated to apply electrical pulses between the conductive distal end of the shaft and the surface electrode to induce non-thermal ablation of the treatment site.
The invention uses bi-phasic electrical pulses and pulse parameters configured to mitigate muscle contractions without the administration of a paralytic. The pulses include a voltage of between about 2,500 V and about 10,000 V and are configured to create a first ablation zone and a first electrical pull zone such that a size of the first ablation zone is increased in the first electrical pull zone.
In additional configurations, the pulses are applied according to parameters comprising a bi-phasic waveform, a pulse width of between about 100 nanoseconds and about 10 microseconds, burst widths of between about 500 nanoseconds and about 1 millisecond, and a time delay between bursts of between about 1 millisecond and about 5 seconds. The invention further includes configurations that create a first spherical ablation zone and a first electrical pull zone in which the size of the first spherical ablation zone is increased in the first electrical pull zone. Additional pulse delivery to create a second electrical pull zone is also described as further increasing the size of an initial ablation zone.
Claims Coverage
The document includes three independent claims. Across these independent claims, the inventive features center on monopolar HFIRE non-thermal ablation using a conductive distal shaft tip and a surface electrode, with pulse parameters and geometry configured to mitigate muscle contractions without a paralytic and to enlarge ablation via electrical pull zones, including a first spherical ablation zone.
Monopolar electrode advanced within a shaft with a conductive distal end
A monopolar electrode is advanced through a shaft positioned within the treatment site such that the monopolar electrode does not extend distally of a distal end of the shaft, wherein the distal end of the shaft is conductive.
Surface electrode and HFIRE non-thermal ablation
Placing a surface electrode on a surface of the patient and activating a generator to apply a first set of electrical pulses between the conductive distal end of the shaft and the surface electrode in an amount sufficient to induce non-thermal ablation of the treatment site by high-frequency irreversible electroporation (HFIRE).
Bi-phasic pulse parameters to mitigate muscle contractions without a paralytic
Activating the generator to apply a first set of electrical pulses including bi-phasic pulses having a delay between adjacent pulses and wherein the first set of electrical pulses have a voltage of between about 2,500 V and about 10,000 V, thereby enabling treatment while mitigating muscle contractions without the administration of a paralytic to the treatment site.
Electrical pull zone increases ablation zone size
Creating a first ablation zone and a first electrical pull zone such that a size of the first ablation zone is increased in the first electrical pull zone.
Conductive sharp distal tip with insulation sleeve portion
The distal end of the shaft includes a sharp distal tip and the shaft includes an insulation sleeve portion that is positioned proximally of the sharp distal tip, wherein the sharp distal tip comprises about 1 cm of exposure from the insulation sleeve portion.
Pulse waveform and timing/voltage constraints
Applying the first set of pulses according to parameters that mitigate muscle contractions and obviate a need to deliver a paralytic, wherein the parameters comprise: a bi-phasic waveform, a pulse width of between about 100 nanoseconds and about 10 microseconds, a delay between adjacent pulses, a voltage of between about 2,500 V and about 10,000 V, burst widths of between about 500 nanoseconds and about 1 millisecond, and a time delay between bursts of between about 1 millisecond and about 5 seconds.
Spherical ablation zone enlargement by electrical pull zone
Creating a first spherical ablation zone and a first electrical pull zone such that a size of the first spherical ablation zone is increased in the first electrical pull zone.
Across the independent claims, the inventive core is monopolar HFIRE non-thermal ablation using a shaft with a conductive sharp distal tip, a surface electrode, and a first set of bi-phasic electrical pulses with specified voltage and time-structure constraints. The ablation is configured to include electrical pull zones that increase the size of the ablation zone, including a first spherical ablation zone, while mitigating muscle contractions without administering a paralytic.
Stated Advantages
Enables treatment while mitigating muscle contractions without the administration of a paralytic to the treatment site.
Increases the size of the first ablation zone in the first electrical pull zone.
Increases the size of the first spherical ablation zone in the first electrical pull zone.
Documented Applications
A method for ablating cells in a treatment site of a patient.
Creating a first ablation zone and a first electrical pull zone to increase ablation size in the treatment site of a patient.
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