舒感電漿活膚儀(Gentle Plasma Skin Regenerator Model 2, GPSR_M2)先前已完成六例首次人體臨床試驗，確認了初步安全性及有效性。本研究延續進行臨床試驗，並在通過衛生福利部食品藥物管理署(TFDA)，以及國立成功大學醫學院附設醫院人體研究倫理審查會(NCKU IRB)兩單位的修正案後，持續收案。最新結果顯示GPSR_M2在治療過程中無重大不良反應，顯示良好安全性；有效性方面，雖然目前僅完成至第28天的傷口追蹤，初步結果顯示在特定菌種上，例如革蘭氏陰性菌中的奇異變形桿菌，電漿治療具有抑菌潛力，後續仍需擴大樣本並延長觀察以驗證其成效。而在透過臨床施作的過程中可觀察到，慢性傷口的面積較大，且因電漿手持部需與傷口維持約5 mm距離，醫師需長時間施打，造成手部與肩部負擔較大。因此，本研究引入視覺型機械手臂，將其與GPSR_M2整合，輔助醫師進行電漿治療。本研究透過設計雙電漿系統作為機械手臂的末端執行器，與具有辨識傷口位置資訊之視覺型機械手臂結合，構成一套仿醫生操作之機械手臂電漿治療系統。本系統兼顧臨床使用需求與硬體整合技術，並具高精度控制能力。經實驗證明，水平方向與工作距離的精度可到達2 mm以內，而電漿移動速度的誤差可控制1.78 %以內，顯示此系統穩定性。電漿的安全性方面，依據為DIN SPEC 91315，電漿裝置能成功激發電漿，產生活性物種，並且溫度位於規範之40 °C以下，以及紫外光含量位於3000 μJ/cm2以下，符合安全規範。最後，為了提升未來患者對於機械手臂介入治療的接受度，本研究模擬臨床醫師實際操作路徑作為機械手臂移動軌跡。實驗結果顯示，機械手臂的移動軌跡與醫師的操作軌跡關節角度相差於10°之下，顯示此仿醫生操作之機械手臂電漿治療系統應用於臨床上的潛力。

The Gentle Plasma Skin Regenerator Model 2 (GPSR_M2) previously completed 6 first-in-human clinical cases, confirming preliminary safety and efficacy. This study continues after protocol amendments were approved by the Taiwan Food and Drug Administration (TFDA) and the Institutional Review Board of National Cheng Kung University Hospital (NCKU IRB). Recent results show no major adverse events, indicating good safety. Although wound healing data is available only up to Day 28, initial findings suggest antibacterial potential against certain strains, particularly Gram-negative bacteria such as Proteus mirabilis. Further studies with more cases and extended follow-up are needed. In clinical use, maintaining an approximately 5 mm distance between the handheld device and the wound increased physician fatigue and operation errors. To address this, a vision-guided robot arm was integrated with GPSR_M2 for plasma delivery. A dual-plasma system was designed as the robot end-effector and combined with wound localization, forming a doctor-mimicking robot plasma system. This system meets clinical needs, with horizontal and working distance accuracy within 2 mm, and movement error under 1.78%, demonstrating system stability. The device complies with DIN SPEC 91315, with plasma generation, reactive species, temperature under 40 °C, and UV exposure below 3000 μJ/cm². To improve patient acceptance, the robot followed physician-guided treatment paths, with joint angle deviation within 10°, demonstrating clinical potential.

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