An integrated implantable device for IRE-based endoluminal focal treatment and therapeutic efficacy assessment

Irreversible electroporation (IRE), which relies on high-voltage pulsed electric fields, has emerged as a promising nonthermal ablation strategy for tumor therapy. However, current endoscopy-assisted IRE systems driven by conventional pulse generators still face several limitations, including incomplete ablation, dependence on kilovolt-level voltages, and delayed evaluation of therapeutic outcomes. To address these challenges, we developed a wireless, battery-free, implantable device for IRE treatment and real-time efficacy assessment that integrates IRE treatment with impedance spectroscopy for gastric cancer therapy and real-time efficacy assessment. The device is powered intragastrically through resonant wireless power transfer, while radio-frequency communication enables data transmission. A flexible printed circuit board integrates an adjustable pulse generator with an output of 0–200 V and a pulse width of 2–125 \(\mu\) s, together with an impedance-sensing module. The system adopts spatially separated but functionally complementary concentric ablation electrodes and annular impedance-sensing electrodes. Finite-element simulations demonstrated that, compared with interdigital electrodes, the concentric electrode configuration provided superior electric-field focusing and increased the ablation depth by 49.34%. Experimental results showed that the folded device had a compact size of 11 mm \(\times\) 8 mm \(\times\) 24.5 mm and achieved wireless power delivery and data transmission through 6 cm of porcine tissue. At 200 V, the device produced an effective ablation depth of 2.04 mm in a potato tissue model, confirming the feasibility of low-voltage IRE treatment. Moreover, the relative change in impedance spectra varied monotonically with ablation voltage, enabling immediate assessment of ablation efficacy. This study introduces an innovative minimally invasive implantable strategy for gastric cancer treatment and treatment response assessment, overcoming the limitations imposed by conventional reliance on external high-voltage pulse generators while enabling immediate evaluation of therapeutic efficacy.