Spinery (RF) Needles are composed by a handle with electrode cooled needle and are offered in bipolar configurations. The available variants consist of cooled needles capable of providing irrigation of tissue through needle tip during ablation procedure. The needle is hollow and its inner space is divided into 3 concentric lumens: • the inner central lumen is used to distally deliver the irrigation solution to the tip of the RF needle; a hole on the needle tip allows the irrigation solution to reach tissues (the irrigation solution could be also delivered proximally through the insulation and irrigation cannula); • the intermediate lumen is used to deliver a cooling fluid through the proximal SpineryTM RF Ablation System by Axon Spine Medical Systems thermocouple; • the outer external lumen returns the cooling fluid from the proximal thermocouple towards the cooling tubing circuit connected to the handle of the RF needle device; the cooling fluid is not intended to come in contact with patient tissue because it flows in a closed circuit. The needles also contain two thermocouples, a distal thermocouple inside the ablation area and proximal thermocouple at the edge of ablation area that permit real-time monitoring of temperatures at the center of the ablation zone and at the edge of ablation area ensuring that no healthy tissue around tumor is damaged.
A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a bipolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes distal electrodes in a bipolar arrangement and may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.