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Circumferential Targeted Renal Sympathetic Nerve Denervation with Preservation of the Renal Arterial Wall Using Intra-Luminal Ultrasound

机译:环行靶向肾交感神经去神经并使用腰椎内超声保存肾动脉壁

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An intra-luminal ultrasound catheter system (ReCor Medical's Paradise System) has been developed to provide circumferential denervation of the renal sympathetic nerves, while preserving the renal arterial intimal and medial layers, in order to treat hypertension. The Paradise System features a cylindrical non-focused ultrasound transducer centered within a balloon that circulates cooling fluid and that outputs a uniform circumferential energy pattern designed to ablate tissues located 1 -6 mm from the arterial wall and protect tissues within 1 mm. RF power and cooling flow rate are controlled by the Paradise Generator which can energize transducers in the 8.5-9.5 MHz frequency range. Computer simulations and tissue-mimicking phantom models were used to develop the proper power, cooling flow rate and sonication duration settings to provide consistent tissue ablation for renal arteries ranging from 5-8 mm in diameter. The modulation of these three parameters allows for control over the near-field (border of lesion closest to arterial wall) and far-field (border of lesion farthest from arterial wall, consisting of the adventitial and peri-adventitial spaces) depths of the tissue lesion formed by the absorption of ultrasonic energy and conduction of heat. Porcine studies have confirmed the safety (protected intimal and medial layers) and effectiveness (ablation of 1-6 mm region) of the system and provided near-field and far-field depth data to correlate with bench and computer simulation models. The safety and effectiveness of the Paradise System, developed through computer model, bench and in vivo studies, has been demonstrated in human clinical studies.
机译:已开发出腔内超声导管系统(ReCor Medical的Paradise系统),以提供肾交感神经的周围神经支配,同时保留肾动脉内膜和内侧层,以治疗高血压。 Paradise System具有一个圆柱形非聚焦超声换能器,该超声换能器位于使冷却液循环的气球中心,并输出均匀的圆周能模式,以消融距动脉壁1 -6 mm的组织并保护1 mm以内的组织。射频功率和冷却​​流量由天堂发生器控制,该发生器可以在8.5-9.5 MHz频率范围内为换能器供电。使用计算机模拟和模仿组织的模型模型开发适当的功率,冷却流速和超声处理持续时间设置,以为直径5至8毫米的肾动脉提供一致的组织消融。这三个参数的调制允许控制组织的近场深度(最靠近动脉壁的病变边界)和远场(距动脉壁最远的病变边界,由外膜和外膜周围间隙组成)深度病变是由超声波能量的吸收和热量的传导所形成的。猪的研究已经证实了该系统的安全性(保护内膜和中间层)和有效性(消融1-6毫米区域),并提供了近场和远场深度数据,以与工作台和计算机仿真模型相关联。通过计算机模型,实验台和体内研究开发的天堂系统的安全性和有效性已在人体临床研究中得到证明。

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