Symbiotic Intrabody Networks for Bioelectronic Therapeutics

转型研究愿景我们的目标是创建一个无线联网治疗植入物的平台，这些植入物通过从人体自身的能量供应（葡萄糖）中获取能量来供电。能量收集的使用将允许更小的植入物，更容易的手术实施，因此使用更广泛。多个植入物相互可靠通信的能力将允许新型的个性化医疗。特别地，它将允许根据来自全身的感测信息来调整治疗干预。临床应用空间在世界各地，社会正在迅速老龄化，因此一个关键的挑战是确保尽可能多的人健康的最佳寿命。药物治疗一直在改进，但很难最佳地调节或调整身体的功能，以正常的日常周期。因此，近年来人们对生物电子解决方案的兴趣激增。例如，SetPoint Medical刚刚获得FDA批准（2020年秋季）用于治疗关节炎的迷走神经植入物。在英国，Galvani希望通过已经在进行的试验取得类似的成功。生物电子学有许多操作模式-包括心脏，大脑和身体的起搏器，感觉恢复（聋人和盲人），以及短期治疗应用，如支持阿片类药物戒断。因此，市场非常大，预计在未来几十年内将迅速增长。首先，我们将针对心律失常。为什么选择我们的团队？我们汇集了英国领先的生物电子专家团队，他们在微电子，超声波通信，微型燃料电池，人工智能和医疗设备设计方面具有丰富的知识，以推动该项目的发展。此外，团队中有三人在医疗技术行业有直接经验，我们分别参与了多个大型临床翻译项目。我们坚信，我们可以在这个高风险，高回报的项目中取得成功，因为我们已经为每个组件创建了工作预配置。为什么是现在？生物电子植入物的尺寸一直在稳步缩小。Medtronic Micro心脏起搏器现在的直径相当于一支标记笔。然而，由于植入式电池需要铠装，因此进一步的封装是困难的。在装甲板的最小尺寸下，尺寸的进一步减小将使电池容量可以忽略不计。此外，现有的植入物作为独立的实体，只能在其附近进行感知。因此，例如，难以完全同步心脏的左心室和右心室刺激。根据身体其他部位的临床体征对内脏器官（例如肝脏或胰腺）进行类似的同步刺激，如果不是不可能的话，目前也是非常具有挑战性的。基础创新：我们的建议基于我们在各自实验室中一直在开发的两种突破性能力，并且现在才成为可能：1.葡萄糖能量采集：我们现在能够从身体间质液中的葡萄糖中采集足够的能量来驱动心脏起搏器。收割机的核心是一个燃料电池，它使用金属纳米结构催化剂，其结构可扩展到体内长期运行。2.可靠的超声体内通信：我们开发了一种具有内置纠错功能的原型超声通信方案，该方案首次允许分散植入物之间进行可靠的通信。当优化用于体内网络时，我们的系统将允许分散的传感和智能，这是目前不可能的。

TRANSFORMATIVE RESEARCH VISIONWe aim to create a platform of wirelessly networked therapeutic implants which are powered by harvesting energy from the body's own energy supply: glucose. The use of energy harvesting will allow for much smaller implants with much easier surgical implementation, and thus much wider use. The ability of multiple implants to reliably communicate with each other will allow for new types of personalised medical therapies. In particular, it will allow for tuning of the therapeutic interventions according to sensed information from across the body. CLINICAL APPLICATION SPACEAcross the world, societies are rapidly ageing, so a key challenge is to ensure healthy optimal lifespans for as many as possible. Drug therapies have been improving, but it can be difficult to optimally modulate or tune the body's function to the normal daily cycle. So, in recent years there has been a surge of interest in bioelectronic solutions. For example, SetPoint Medical just received FDA approval (Autumn 2020) for a vagal nerve implant to treat arthritis. Here in the UK, Galvani is hoping to achieve similar success with trials already underway.Bioelectronics has many modes of operation - including pacemakers for heart, brain and body, sensory restoration (for the deaf and blind), and short-term healing applications such as supporting opioid withdrawal. The market is therefore very large, and expected to grow rapidly in the coming decades. In the first instance, we will target Cardiac Arrhythmias.WHY OUR TEAM? We have brought together a leading UK team of bioelectronic experts with knowledge in microelectronics, ultrasonic communication, micro-fuel cells, artificial intelligence, and medical device design to push this project forward. Furthermore, three of the team have direct experience in the medical technology industry, and we have separately been involved in multiple large clinical translation projects. We strongly believe we can achieve success in this high-risk, high-reward project as we have already created working pre-requisites for each of the components. WHY NOW?Bioelectronic implants have steadily been reducing in size. The Medtronic Micro cardiac pacemaker now has the diameter of a marker pen. However, further miniaturisation is difficult because implantable batteries need to be armoured. Further decreases in size will make battery capacity negligible given the minimum dimensions of the armour plate. Furthermore, existing implants act as independent entities and can only sense in their immediate vicinity. As such it is difficult, for example, to fully synchronise the left and right ventricle stimulation of the heart. Similarly synchronous stimulus of an internal organ, e.g. the liver or pancreas, according to clinical signs elsewhere in the body is currently very challenging, if not impossible.UNDERPINNING INNOVATIONS: our proposal is based on two breakthrough capabilities that we have been developing in respective labs, and are only now becoming possible:1. GLUCOSE ENERGY HARVESTING: We are now able to harvest sufficient energy to drive a cardiac pacemaker from glucose in the body's interstitial fluid. At the core of the harvester is a fuel cell that uses metallic-nanostructured catalysts with an architecture scalable to long term operation inside the body. 2. RELIABLE ULTRASONIC INTRABODY COMMUNICATIONS: We have developed a prototype ultrasound communication scheme with in-built error correction, which can, for the first time, allow for reliable communication between disperse implants. When optimised for use in intrabody networks, our system will allow for dispersed sensing and intelligence not currently possible.