Device and method for electroporation based treatment
Inventors
Neal, Robert E. • Garcia, Paulo A. • Davalos, Rafael V. • Callas, Peter
Assignees
Virginia Tech Intellectual Properties Inc • Angiodynamics Inc
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Publication Number
US-12232792-B2
Publication Date
2025-02-25
Expiration Date
Abstract
The present invention relates to medical devices and methods for treating a lesion such as a vascular stenosis using non-thermal irreversible electroporation (NTIRE). Embodiments of the present invention provide a balloon catheter type NTIRE device for treating a target lesion comprising a plurality of electrodes positioned along the balloon that are electrically independent from each other so as to be individually selectable in order to more precisely treat an asymmetrical lesion in which the lesion extends only partially around the vessel.
Core Innovation
The invention relates to a method for treating a target lesion by irreversible electroporation using a plurality of elongated electrodes disposed lengthwise and circumferentially spaced from one another at the target lesion. Electrical pulses are administered by activating a generator to deliver the pulses through only selected electrodes among the plurality, where the selected electrodes comprise a number of electrodes less than a total number of electrodes. Tissue proximate the energized electrodes is treated, while tissue proximate un-energized electrodes is substantially untreated.
A core feature is that at least one electrical pulse is applied to a first pair of electrodes comprising a first electrode and a second electrode separated by at least one unenergized electrode. The pulse duration is limited to from 1 μs to 1 ms, and the delivery is arranged so that the energization pattern includes leaving at least one electrode unenergized to provide substantially untreated tissue near those unenergized electrodes. This selective energization is described as supporting non-thermal irreversible electroporation and non-thermal ablation of cells of the target lesion.
The described system and method also enable individualized treatment control based on imaging markers and electrical measurements, including radiopaque markers and IVUS, and the use of non-electroporating test pulses followed by measurement of electrical resistance and electrical impedance or electrical impedance tomography to determine electrode proximity or orientation relative to the lesion. Numerical modeling is described for electric-field and temperature distributions, including demonstrating that selective two-electrode energization can extend treatment margins without thermal damage by analyzing Joule heating and temperature modeling associated with thresholds for protein denaturation/scarring.
Claims Coverage
The independent claims (two) cover a selective-electrode irreversible electroporation treatment method that includes at least one pulse with a 1 μs to 1 ms pulse duration, and where only selected electrodes among a larger plurality are energized so that tissue near energized electrodes is treated while tissue near unenergized electrodes is substantially untreated. Across the independent claims, the main inventive features are the selective electrode activation pattern (including energizing electrode pairs separated by unenergized electrodes) and generator activation through only selected electrodes for non-thermal ablation/irreversible electroporation.
Selective electrode delivery via generator through only selected electrodes
Activating a generator to administer a plurality of electrical pulses through only the selected electrodes to the target lesion in an amount sufficient to induce irreversible electroporation of cells of the target lesion, wherein administration through only the selected electrodes treats tissue proximate the energized electrodes while tissue proximate the un-energized electrodes is substantially untreated.
Pulse application to a pair separated by unenergized electrode
Applying at least one electrical pulse to a first pair of electrodes comprising a first electrode and a second electrode separated by at least one unenergized electrode.
Pulse duration limited to 1 μs to 1 ms
Applying at least one of the electrical pulses with a pulse duration of from 1 μs to 1 ms.
Selected electrodes comprise fewer electrodes than the plurality
Wherein the selected electrodes includes a number of electrodes less than a total number of electrodes in the plurality of elongated electrodes.
Substantially untreated tissue near unenergized electrodes
Treating tissue proximate the energized electrodes while tissue proximate the un-energized electrodes is substantially untreated.
Overall, the independent claims focus on inducing irreversible electroporation/non-thermal ablation by energizing only a subset of electrodes, including energizing electrode pairs separated by unenergized electrodes, with pulse duration from 1 μs to 1 ms, and producing selective treatment where tissue near energized electrodes is treated and tissue near unenergized electrodes is substantially untreated.
Stated Advantages
Non-thermal irreversible electroporation with substantially untreated tissue proximate un-energized electrodes.
Non-thermal ablation of cells of the target lesion while tissue proximate un-energized electrodes is substantially untreated.
Selective energization can extend treatment margins without thermal damage (as supported by numerical modeling).
Documented Applications
Treating a target lesion including stenosis/rest enosis, including asymmetrical lesions.
Directional uses described include reversible electroporation for electrochemotherapy/electrogenetherapy, gene delivery (directional gene transfer), and tumor ablation [procedural detail omitted for safety].
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