Devices, systems, and methods for pulsed electric field treatment of the duodenum
Inventors
D'Agostino, Robert Anthony • Batchelder, John Samuel • Logan, John Bernard • Peterson, Alex Alden • Brenzel, Michael Patrick • Fanger, Corey Addison • Ballard, John Robert • Hindrichs, Paul • Heidner, Matthew
Assignees
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Publication Number
US-12186011-B2
Publication Date
2025-01-07
Expiration Date
Abstract
Described here are devices, systems, and methods for applying pulsed or modulated electric fields to tissue. In some variations, a device may comprise a first elongate body comprising a lumen, a second elongate body at least partially positioned within the lumen, and an expandable member rolled about the second elongate body. The expandable member may comprise an inner end coupled to the second elongate body, an outer end coupled to the first elongate body, and an electrode array.
Core Innovation
The invention is a device for treating tissue of a patient that includes a first elongate body comprising a lumen and a second elongate body at least partially positioned within the lumen. An expandable member is rolled about the second elongate body and comprises an electrode array, with an inner end coupled to the second elongate body and an outer end coupled to the first elongate body. The expandable member is transitioned between rolled and unrolled configurations using gears coupled to the second elongate body or directly engaging the expandable member.
The disclosure further provides a system in which an electrode array is configured to deliver a pulsed or modulated electric field waveform to tissue. The system generates a therapeutic electric field at a first tissue depth of about 1 mm while generating a non-therapeutic electric field at a second tissue depth of at least about 1.5 mm. In this configuration, the electrode array is used to target predetermined cell types while not treating muscularis tissue.
The invention also incorporates signal generation and treatment control aspects that support depth selectivity and temperature-based pulse inhibition. The signal generator is configured to deliver waveforms to perform electroporation, and delivery can be inhibited based on tissue temperature. The expandable-member configuration is controlled via gears to support visualization through an expandable-member lumen and localized treatment using optional fiducial or thermal markers.
Claims Coverage
The independent claims identified across the items are three, and the main inventive features are a gear-driven expandable electrode array on dual elongate bodies with a lumen, an electroporation system delivering pulsed or modulated electric-field waveforms with therapeutic versus non-therapeutic tissue-depth effects, and a gear-rolled expandable member defining an electrode-array configuration.
Gear-driven expandable member electrode array on dual elongate bodies with lumen
A device for treating tissue of a patient including a first elongate body comprising a lumen, a second elongate body positioned within the lumen, an expandable member rolled about the second elongate body with an inner end coupled to the second elongate body and an outer end coupled to the first elongate body, and an electrode array, with gears coupled to the second elongate body to transition the expandable member between rolled and unrolled configurations.
Depth-selective electroporation using a pulsed or modulated electric-field waveform
A system for electroporating tissue to treat a condition of a patient including an elongate body, a gear coupled to the elongate body, an expandable member coupled to the gear and the elongate body and configured to transition between a compressed configuration and an expanded configuration having a diameter greater than about 25 mm, the expandable member further comprising an electrode array comprising a plurality of electrodes, and a signal generator coupled to the electrode array and configured to deliver a pulsed or modulated electric field waveform to generate a therapeutic electric field at a first tissue depth of about 1 mm and a non-therapeutic electric field at a second tissue depth of at least about 1.5 mm.
Gear-rolled expandable member with electrode array
A device for treating tissue of a patient including a first elongate body comprising a lumen, a second elongate body at least partially positioned within the lumen, an expandable member rolled about the second elongate body and comprising an inner end coupled to the second elongate body, an outer end coupled to the first elongate body, and an electrode array, and a gear coupled to the second elongate body and directly engaging the expandable member such that rotation rolls and unrolls the expandable member about the second elongate body.
Across the independent claims, the inventive concept is a gear-driven expandable electrode array carried on a dual-elongate architecture with a lumen, used with a signal generator to deliver pulsed or modulated electric field waveforms for electroporation with therapeutic versus non-therapeutic tissue depths.
Stated Advantages
Targets predetermined cell types while not treating muscularis tissue.
Generates a therapeutic electric field at about 1 mm tissue depth and a non-therapeutic electric field at at least about 1.5 mm tissue depth.
Inhibits delivery of pulse waveform based on tissue temperature.
Enables transition of the expandable member between rolled and unrolled configurations and compressed and expanded configurations with a diameter greater than about 25 mm.
Documented Applications
Electroporating tissue to treat a condition of a patient using a pulsed or modulated electric field waveform delivered by an electrode array.
Treating tissue of a patient using a gear-driven device with an expandable member comprising an electrode array.
Treating diabetes by electroporating or treating duodenal tissue via mucosal resurfacing with suction/dilation for consistent contact and reported healing cascade/necroinflammatory response reduction.
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