一种可植入式多模态生命体征监测设备的改良设计与验证

Refined design and experimental validation of an implantable multimodal vital signs monitoring device

  • 摘要: 背景 现有大动物生命体征监测多需在束缚或麻醉条件下进行,难以实现清醒状态下的连续实时监测,且外接设备易发生脱落、移位或损坏。目的 改良设计一种适用于小型猪模型的可植入式多参数生命体征监测设备,并验证其监测效果。方法 改良设计一种集成单导联心电、体温监测、蓝牙无线传输及充电模块的可植入式生命体征监测设备及配套软件。将设备植入成年雄性巴马小型猪左侧胸前区皮下,采用自身配对对照设计,比较在全麻与镇静状态下植入式设备与常规监护仪测得的心率和体温差异,并观察清醒状态下的监测表现。术后7 天取植入区周围组织行HE染色,以评估局部组织反应和短期组织相容性。结果 监测设备可在全麻、镇静及清醒状态下监测心电、心率和体温,并实现移动终端实时显示。全麻和镇静状态下,植入式设备与常规监护仪测得心率差异均无统计学意义(均P>0.05),而植入式设备测得体温均高于监护仪鼻腔温度(均P<0.001)。术后动物一般状态良好,植入区未见明显感染,病理示局部轻度炎症细胞浸润。结论 可植入式生命体征监测设备可用于小型猪不同状态下心电、心率和体温的监测,心率测量结果与常规监护仪较为一致,并具有较好的短期植入耐受性。

     

    Abstract: Background Current vital-sign monitoring in large animals usually requires restraint or anesthesia. This makes continuous real-time monitoring in awake animals difficult. In addition, external devices are prone to detachment, displacement, or damage.Objective To modify and develop an implantable multiparameter vital-sign monitoring device for miniature pigs and to evaluate its monitoring performance. Methods We developed an implantable vital-sign monitoring device and supporting software. The device integrated single-lead electrocardiogram (ECG), temperature monitoring, Bluetooth data transmission, and a charging module. The device was implanted into the subcutaneous tissue of the left precordial region in adult male Bama miniature pigs. Using a self-controlled paired design, heart rate and body temperature measured by the implantable device were compared with those measured by a conventional monitor under general anesthesia and sedation. Its monitoring performance in the awake state was also observed. On postoperative day 7, tissue around the implantation site was collected for hematoxylin-eosin (HE) staining to evaluate local tissue response and short-term histocompatibility.Results The device was able to monitor ECG, heart rate, and body temperature under general anesthesia, sedation, and awake conditions, and the data could be displayed in real time on a mobile terminal. Under both general anesthesia and sedation, heart rate measured by the implantable device showed no significant difference from that measured by the conventional monitor (P>0.05). However, the temperature measured by the implantable device was higher than the nasal temperature measured by the conventional monitor (P<0.001). After surgery, the animals remained in good general condition. No obvious infection was found at the implantation site. Histological examination showed mild local inflammatory cell infiltration.Conclusion The implantable vital-sign monitoring device can be used to monitor ECG, heart rate, and body temperature in miniature pigs under different conditions. Its heart-rate measurements were generally consistent with those of the conventional monitor, and it showed good short-term implantation tolerance.

     

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