胃食管反流病(GERD)是具有患病率在西方世界达到高达10%或20%的相当常见的疾病。最具体的症状,其指向GERD的诊断是胃灼热的感情和酸性胃内容物返流进入食道。然而,患者一定数目的不标准治疗无反应,在这些情况下,有必要采取其他治疗方法,如腹腔镜胃底或食管下括约肌的电刺激。我们的工作的目的是设计和制造的小型,无电池的刺激,以提供下食道括约肌,这可能是深注入到远端食道的粘膜下层的电刺激。的主要目的是提供一种无电池的系统相对于传统电池神经刺激器,以减少装置的尺寸和重量。一个无线供电的植入装置的电子样机开发。我们使用动物模型实验。该器件通过固有肌层的电刺激设计用于治疗GERD。它是由食管下括约肌用内窥镜植入到粘膜下的口袋里。植入这种方法优于目前使用的,因为手术非常低侵袭性的食管刺激。 Bipolar neurostimulation via two gold-plated leads is provided. The device does not have any source of energy; it is powered wirelessly which reduces the risk of potential battery leakage and reduces the overall dimensions.
虽然下食道括约肌的电刺激治疗是针对谁是病人对药物的抗性也,该疗法是安全和有效的短期和长期研究在人类[治疗一个比较新的概念
3.,
4,
6,
8],没有出现过负面影响这种形式的治疗,它已被证明,而在同一时间消除了对PPI的药物的需求,并减少食管酸暴露于GERD症状同时提供显著和持续的缓解。犬模型首次用于研究治疗胃食管反流病的LES的电刺激的影响[
9,
10]。Reports have stated that electric stimulation (20 Hz, pulse width of 3 ms) with 2 pairs of electrodes causing a contraction and increase of the pressure of the sphincter complex was effective in preventing gastroesophageal reflux. The effects of electrostimulation of the LES in patients with GERD using both high (20 Hz, pulse width of 200
μs)和低(6周期每分钟,脉冲宽度375 ms)频率也被检查。高频和低频电刺激均可增加吞咽时的LES压,但不影响吞咽时的LES放松或残余压[
2]。它已经显示,高频刺激是优选的,因为它需要较少的能量,并且因此延长了电池的寿命。只有两个GIT刺激目前在使用中,Enterra II [
11]和内生[
12,它使用肌内导管刺激胃肌肉组织。这两种手术都需要在全身麻醉的情况下进行植入,并且需要附着一个巨大而笨重的装置。因此,在胃粘膜下植入无线通讯设备将是病人舒适度的一大进步。我们也评估了经鼻内窥镜植入导线对LES的神经刺激效果,并取得了成功,结果LES压力显著增加,而无吞咽困难[
4]。研究已经证明,它可以植入微型神经刺激到黏膜下层[
13,
14]。该研究提供了用于与电力管理(特别是无电池无线电力设备的选项)的进一步改进,符合规则和条例的医疗植入物和无线通信和双极neuroelectrostimulation的可能性范围。
在这个频率范围内的近场无线电力传输可以仅由具有高导电性的材料通过在它们(金属)或具有高磁导率(例如,MU-金属或坡莫合金)材料制造涡流显著影响。为了支持这一说法,进行了实验(图
2)。We have secured a wireless receiver coil with a parallel resonant capacitor and wireless transmitter 11 cm apart each other. The first measurement was done with no object placed between the coils. A 1 kOhm resistor was placed across the receiving coil resonant circuit to simulate an electric load. The voltage across the resistor with energy transfer active was measured, and received power was calculated using Ohm’s law. After that, the experiment was repeated but in between transmitting and receiving coil, an 8 cm thick porcine tissue was placed. The average power (averaged over 10 seconds) received with and without animal tissue in between was 0.560 mW and 0.588 mW, respectively. This is in accordance with the theory that the effect of tissue on this type of wireless power transfer is minimal (4.7% decrease). One of the possible explanations of the decrease is detuning of the transmitting LC circuit. This may be compensated for during development, and the effect of the tissue presence will be further minimized (at the same distance and angular position of the coils, the power transferred will be smaller without the presence of the tissue).
使用相同的内窥镜黏膜下层隧穿方法通常用于POEM,首先由Inoue等人描述。[
15,该装置被植入粘膜下层。此过程如图所示
4。A combination of methylene blue and saline solution is first injected about 5 cm above the LES into the submucosal layer with a therapy needle catheter (25G). An electrosurgical knife is used to make an opening into the submucosa. This submucosal pocket is then dilated and disrupted, thus creating a 5 cm long tunnel large enough for the implantation of the device. Using a grasper, the device is moved into the area of the pocket and released. Grasping forceps then move the device into the submucosal tunnel. The opening made by the initial incision is then closed with haemostatic clips.
在装置周围制造生物相容外壳的新方法适合于短期实验。当进行较长时间的实验时(例如。,weeks), there is a possibility that moisture could leak into the implant via the interface between the PCB and outside of the implant where the stimulation electrodes are located. In that case, a layer of conformal coating of the PCB before coating the PCB with biocompatible 3D printing resin could add sufficient protection. In the case of a not biocompatible material, there is a significant risk of implant rejection. Also, the implant could be prone to migration, requiring additional solution for fixation.