Methods of treatment using treatment applicator with protected electrodes
Inventors
Moss, Kevin L. • Foster, Christopher J. • Hinman, Cameron D. • Danitz, David J. • Uecker, Darrin R.
Assignees
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Publication Number
US-12128231-B2
Publication Date
2024-10-29
Expiration Date
Abstract
Described herein are methods of treating a tissue using a treatment tip apparatus (e.g., devices, systems, etc.) including one, or more preferably a plurality, of electrodes that are protected by an electrode partition, such as an electrode housing (which may be retractable) until pressed against the tissue for deployment of the electrodes and delivery of a therapeutic treatment. In particular, these methods may include the use of a plurality of treatment electrodes (e.g., needle electrodes) and in some examples may include for the delivery of nanosecond pulsed electric fields.
Core Innovation
The invention relates to retractable treatment-tip devices and methods for treating a subject using energy delivered from a plurality of treatment electrodes, including needle electrodes, where the electrodes are electrically protected and isolated by an electrode housing having a soft, electrically insulating distal end face. In an un-deployed configuration, distal ends of the plurality of treatment electrodes are housed within the electrode housing and do not extend beyond the soft, electrically insulating distal end of the electrode housing.
During use, the electrode housing is driven or pushed adjacent to the subject’s tissue, converting the applicator to a deployed configuration. In the deployed configuration, the electrically insulated distal end of the electrode housing retracts proximally relative to the plurality of treatment electrodes while the plurality of treatment electrodes extend beyond the soft, electrically insulating distal end and into the subject’s tissue.
The method further holds the soft, electrically insulating distal end against the subject’s tissue when energy is applied from the plurality of treatment electrodes. This electrically isolates the plurality of treatment electrodes and prevents or reduces arcing when energy is applied to the subject’s tissue, including when applying nanosecond electrical pulses.
The claims and description emphasize mechanical deployment using bias and a threshold force to hold or extend the electrode housing in the un-deployed configuration, and then to drive or push it relative to the plurality of needle electrodes. The soft electrically insulating distal end is characterized by material properties, including a durometer of 60 or less on the Shore A hardness scale, and the approach is described as compatible with nsPEF/sub-microsecond pulsed electric field treatment without insulating gel while using a pulse generator/controller system.
Claims Coverage
The partial content provides three independent claims. Across these independent claims, the core inventive theme is a retractable electrode housing having a soft electrically insulating distal end that is held against tissue to electrically isolate multiple needle electrodes and prevent or reduce arcing during energy delivery. The inventive features include deploying and retracting the insulating distal end relative to the electrodes and applying energy, including nanosecond electrical pulses, from the electrode tips while maintaining insulating isolation at the tissue interface.
Deployable electrode housing with soft insulating distal end held against tissue to prevent arcing
Placing an electrode housing of a treatment applicator adjacent to the subject's tissue in an un-deployed configuration in which distal ends of a plurality of treatment electrodes are housed within the electrode housing and do not extend beyond a soft, electrically insulating distal end of the electrode housing; driving the electrode housing against the subject's tissue to convert the treatment applicator to a deployed configuration in which the electrically insulated distal end retracts proximally relative to the plurality of treatment electrodes and the plurality of treatment electrodes extend beyond the soft, electrically insulating distal end and into the subject's tissue; and holding the soft, electrically insulating distal end against the subject's tissue to prevent arcing between the plurality of treatment electrodes when energy is applied from the plurality of treatment electrodes.
Bias-retracted electrode housing with needle electrodes and insulated distal end for arcing reduction during energy application
Positioning an electrode housing of a treatment tip against the subject's tissue in an un-deployed configuration in which the electrode housing extends over a plurality of needle electrodes and includes a soft, electrically insulating distal end; deploying the treatment tip by driving the electrically insulated distal end of the electrode housing against the subject's tissue so that the electrode housing is retracted into a treatment tip housing against a bias while the plurality of needle electrodes are inserted into the subject's tissue; applying energy to the subject's tissue from the plurality of needle electrodes while the soft, electrically insulating distal end is applied against the subject's tissue to electrically isolate the plurality of needle electrodes and prevent or reduce arcing.
Shore A durometer-limited soft insulating distal end with nanosecond pulses during pushing deployment
Positioning an electrode housing adjacent to the subject's tissue extending from a distal end of a treatment tip housing, where a bias applies a bias force to hold the electrode housing extended over a plurality of needle electrodes within the electrode housing and where the electrode housing includes a soft, electrically insulating distal end having a durometer of 60 or less on the Shore A hardness scale; pushing the treatment tip against the subject's tissue with a force greater than the bias force to drive the electrode housing proximally relative to the plurality of needle electrodes while penetrating the subject's tissue with the plurality of needle electrodes; and applying nanosecond electrical pulses to the subject's tissue from the plurality of needle electrodes while holding the soft, electrically insulating distal end against the subject's tissue to electrically isolate the plurality of needle electrodes and prevent or reduce arcing.
Across the independent claims, the coverage focuses on methods that use an electrode housing with a soft electrically insulating distal end that remains in contact with tissue during energy delivery. Deployment retracts the electrode housing relative to the electrodes while maintaining insulating isolation at the tissue interface, including under biased and threshold-force deployment mechanics and, in one independent claim, with nanosecond electrical pulses and a Shore A durometer of 60 or less.
Stated Advantages
Prevents arcing between the plurality of treatment electrodes when energy is applied.
Prevents or reduces arcing by electrically isolating the plurality of needle electrodes using the soft, electrically insulating distal end held against the subject’s tissue.
Electrically isolates the plurality of needle electrodes during energy application.
Documented Applications
Treating a subject using high-voltage nanosecond pulsed electric field (nsPEF) or sub-microsecond pulsed electric field therapy, including tumor/apoptosis-related treatment.
Treating cancer, including skin cancer.
Dermatologic and cosmetic treatments, including cosmetic treatments such as tattoo removal and wrinkle reduction.
Treatment applicator operation emphasized as arcing-reduced operation without insulating gel and compatibility with pulse generator systems.
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