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Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is intended to guide trained urologists in the planning and positioning of insertion tools during the performance of trans-perineal prostate biopsies and interventional procedures under trans-rectal biplane ultrasound guidance. The procedures include clinical diagnosis and treatment of prostate conditions: biopsy, single or multi-needle ablation, and particle implantation.

The device provides real-time 2D ultrasound scanning of the prostate to construct a 3D model and fuses it with the MRI 3D model, which can assist the surgeon in planning the puncture path avoiding the urethra and pubic bones. The device also provides a 3D simulation showing the current and planned puncture path of insertion tools such as biopsy needle and therapeutic needle, taking into account patient movement.

Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-2) is a clinical device that integrates computer technology, medical imaging technology, navigation technology and robot technology. It can be used to guide surgeons in the planning and positioning of insertion tools (e.g., biopsy needles, therapeutic needles, etc.) during trans-perineal prostate diagnostic and interventional procedures with the guidance of MRI and ultrasound (MRI-TRUS) fusion.

The device allows the importation of multi-parameter MRI images to construct 3D models of the prostate, tumor, urethra, and pubis. It can also construct 3D models based on real-time images from commercial ultrasound system, and provide the fusion between ultrasound and MRI 3D models as the guidance and visualization references for prostate biopsy and interventional procedures. The insertion of biopsy needles or therapeutic needles is performed manually by the surgeon. Other software functions include patient data management, multi-planar reconstruction and segmentation, image measurement, surgical planning, and report generation.

AmaKris SR1-A-2 is composed of two modules: Navigation robotic arm and Intelligent Surgical Console.

The device is used in conjunction with a commercial urological ultrasound device supplied by the hospital. The third-party ultrasound system is composed of a beamformer and a bi-plane transducer (probe) with a linear array and a convex array. The beamformer is connected to AmaKris SR1-A-2's IPC by a USB cable and is powered by a 12V power supply cable. AmaKris SR1-A-2 receives the image signal through the driver software provided by the ultrasound manufacturer and displays it on the screen.

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