A new pneumatic lymphatic drainage device enhancing lymphatic flow in lower limbs with lymphedema: a single-center, single-arm, prospective, open-label, non-randomized, exploratory study.

Lymphedema is the swelling of tissues caused by lymphatic stasis. Intermittent pneumatic compression (IPC), a treatment device for lymphedema, improves lymphatic flow using multiple donut-shaped air chambers with graduated compression from the distal. However, the lymphatic pathway has complicated three-dimensional networks; thus, a simple donut-shaped air chamber cannot adapt to the anatomy. A new pneumatic lymphatic drainage (PLD) device consisting of multiple round air chambers located according to the lymphatic pathways was collaboratively developed with a company. The device's air chambers simulate a therapist's manual lymphatic drainage (MLD) movements; however, the efficacy of this novel PLD is unknown. This feasibility study evaluated the lymphatic flow change by lymphoscintigraphy under PLD in 18 lower limbs with lymphedema and showed that the PLD enhanced lymphatic flow, especially in limbs with mild lymphedema. Previous reports have shown that in patients with lymphedema, improving lymphatic flow requires IPC with a high pressure (~100 mmHg). Although the PLD in this study only utilized mild pressure (50 mmHg) for 10 min, the tracer injected into the distal leg moved stably to the inguinal region. MLD promotes flexible lymphatic flow in response to anatomical variations; however, technical heterogeneity, labor costs, and other problems exist. PLD that can imitate MLD would solve these problems derived from human power.