Candelari Mara, Cappello Ida Anna, Pannone Luigi, Monaco Cinzia, Bori Edoardo, Talevi Giacomo, Ramak Robbert, La Meir Mark, Gharaviri Ali, Chierchia Gian Battista, de Asmundis Carlo, Innocenti Bernardo
Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, European Reference Networks Guard-Heart, 1090 Brussels, Belgium.
BEAMS Department (Bio Electro and Mechanical Systems), Université Libre de Bruxelles, 1050 Brussels, Belgium.
J Clin Med. 2023 Jan 29;12(3):1036. doi: 10.3390/jcm12031036.
The lack of thermally and mechanically performant biomaterials represents the major limit for 3D-printed surgical guides, aimed at facilitating complex surgery and ablations. Cryosurgery is a treatment for cardiac arrhythmias. It consists of obtaining cryolesions, by freezing the target tissue, resulting in selective and irreversible damage. MED625FLX and TPU95A are two biocompatible materials for surgical guides; however, there are no data on their response to cryoenergy delivery. The study purpose is to evaluate the biomaterials' thermal properties, examining the temperature changes on the porcine muscle samples (PMS) when the biomaterials are in place during the cryoablation. Two biomaterials were selected, MED625FLX and TPU95A, with two thicknesses (1.0 and 2.5 mm). To analyze the biomaterials' behavior, the PMS temperatures were measured during cryoablation, firstly without biomaterials (control) and after with the biomaterials in place. To verify the biomaterials' suitability, the temperatures under the biomaterial samples should not exceed a limit of -30.0 °C. Furthermore, the biomaterials' geometry after cryoablation was evaluated using the grid paper test. TPU95A (1.0 and 2.5 mm) successfully passed all tests, making this material suitable for cryoablation treatment. MED625FLX of 1.0 mm did not retain its shape, losing its function according to the grid paper test. Further, MED625FLX of 2.5 mm is also suitable for use with a cryoenergy source. TPU95A (1.0 and 2.5 mm) and MED625FLX of 2.5 mm could be used in the design of surgical guides for cryoablation treatment, because of their mechanical, geometrical, and thermal properties. The positive results from the thermal tests on these materials and their thickness prompt further clinical investigation.
缺乏具有良好热性能和机械性能的生物材料是3D打印手术导板的主要限制因素,而3D打印手术导板旨在辅助复杂手术和消融治疗。冷冻消融术是一种治疗心律失常的方法。它通过冷冻目标组织形成冷冻损伤,从而造成选择性和不可逆的损害。MED625FLX和TPU95A是两种用于手术导板的生物相容性材料;然而,尚无关于它们对冷冻能量传递反应的数据。本研究的目的是评估生物材料的热性能,研究在冷冻消融过程中生物材料就位时猪肌肉样本(PMS)的温度变化。选择了两种生物材料MED625FLX和TPU95A,以及两种厚度(1.0和2.5毫米)。为了分析生物材料的性能,在冷冻消融过程中测量PMS的温度,首先是没有生物材料时(对照),然后是生物材料就位后。为了验证生物材料的适用性,生物材料样本下方的温度不应超过-30.0°C的限值。此外,使用方格纸测试评估冷冻消融后生物材料的几何形状。TPU95A(1.0和2.5毫米)成功通过了所有测试,表明这种材料适用于冷冻消融治疗。根据方格纸测试,1.0毫米厚的MED625FLX无法保持其形状,失去了功能。此外,2.5毫米厚的MED625FLX也适用于冷冻能量源。TPU95A(1.0和2.5毫米)以及2.5毫米厚的MED625FLX因其机械、几何和热性能,可用于设计冷冻消融治疗的手术导板。这些材料及其厚度的热测试阳性结果促使进一步开展临床研究。