A novel medical device for reducing chemotherapy-induced peripheral neuropathy in the hands

我们发明了一种新的颠覆性技术，可以减轻化疗常见的剂量限制和/或使人衰弱的副作用。我们希望优化这项技术，将其嵌入到可穿戴产品中，并将其放在癌症患者手中。化疗诱导的周围神经病变（CIPN）是一种由化疗药物引起的神经损伤，通常始于手和脚，导致疼痛、功能丧失和可见损伤。根据化疗的不同，30-90% （Beijers et al. 2012, Maihöfner et al. 2021）的患者会出现CIPN及其副作用。鉴于英国癌症幸存者的数量将从今天的300万增加到2030年的大约400万（麦克米伦癌症支持，2022年），CIPN的影响将继续增长。目前还没有有效的治疗方法来预防或减少CIPN，并且随着化疗的进展，症状会加重。这意味着患者经常被迫停止治疗，降低了癌症被治愈的可能性。此外，即使化疗成功，仍有四分之一的癌症幸存者因化疗副作用而遭受残疾，其中CIPN占主导地位（Macmillian cancer Support, 2022）。化疗病人的需要没有得到充分满足。目前的解决方法包括冷却皮肤和/或压缩手脚。它们在某种程度上是有效的，但它们的工作原理需要更好地理解。然而，最关键的是，这些方法不是很容易被接受：它们可能很重，有限制性，而且通常不舒服。它们的低温和压力会造成疼痛和伤害，有时甚至会冻伤。此外，这些技术管理起来很麻烦，这意味着癌症护理人员很难使用和支持它们。这些挑战极大地限制了这些解决方案的采用。对于数以百万计可以从预防CIPN中受益的人来说，许多人不会这样做——因为这些解决方案带来了太多的不适，而且无法持续。我们的解决方案可以做得更好。提出的解决方案（潜在应用和益处）我们已经发现了一种在化疗期间使用靶向电刺激减少外周血流量的方法。减少血流量将减少可被指尖和脚趾的神经末梢吸收的有毒化疗药物的量，从而保护周围神经。我们计划创建“Stim-mitts”（工作产品名称）；一种医疗设备，可以改变已经或即将接受化疗的癌症患者和幸存者的经历和结果。独特的是，stim手套工作时安静，经济实惠，而且不限制手部活动，这意味着接受化疗数小时或数天的患者不会无助地束缚在基本上是手臂的束缚上。该产品每年将使全球额外1000万患者受益，其使用的影响将在化疗期间和他们的余生中感受到。

We have invented a new and disruptive technology that can mitigate a common dose-limiting and/or debilitating side-effect of chemotherapy. We want to optimise this technology, embed it into a wearable product, and put it in/on the hands of cancer patients. Context & NeedChemotherapy-induced peripheral neuropathy (CIPN) is a form of nerve damage caused by chemotherapy drugs - it often starts in the hands and feet and causes pain, loss of function and visible damage. Depending on the type of chemotherapy, 30-90% (Beijers et al. 2012, Maihöfner et al. 2021) of patients will suffer from CIPN and its side effects. Given that the number of UK cancer survivors is set to increase from 3 million today to roughly 4 million by 2030 (Macmillian Cancer Support, 2022), the impact of CIPN will continue to grow.There are currently no effective treatments to prevent or reduce CIPN, and symptoms get worse as chemotherapy treatment progresses. This means that patients are often forced to stop their treatment, reducing the likelihood of their cancer being cured. Moreover, even if chemotherapy is successful, one in four cancer survivors suffer disabilities resulting from the side effects of chemotherapy, among which CIPN is dominant (Macmillian Cancer Support, 2022).The needs of chemotherapy patients are not being adequately met.Current solutions involve cooling of the skin, and/or compression of the hands and feet. They're effective to some extent, but their working principles need to be better understood. Crucially however, these approaches are not well-tolerated: they can be heavy, restrictive and generally uncomfortable. Their cold temperatures and pressure can cause pain and damage themselves, sometimes even frostbite. Furthermore, these technologies can be cumbersome to manage, meaning they are difficult for cancer care staff to use and support. These challenges significantly limit the uptake of these solutions. For the millions of people who could benefit from the prevention of CIPN, many won't—because these solutions create too much discomfort and can't be sustained. Our solution can do better. Proposed Solution (Potential Application & Benefits)We have discovered a way to reduce peripheral blood-flow during chemotherapy using targeted electrical stimulation. Reducing blood-flow will lower the amount of toxic chemotherapy drugs available for absorption by the nerve-endings in the fingertips and toes, therefore, protecting the peripheral nerves.We plan to create the 'Stim-mitts' (working product name); a medical device that can transform the experience and outcomes of cancer patients and survivors, who have undergone or will undergo chemotherapy. Uniquely, the Stim-mitts work quietly, affordably and without restricting hand movements—meaning that patients undergoing chemotherapy for hours or days are not bound helplessly to what are essentially arm restraints. This product stands to benefit an additional 10 million patients per year worldwide, and the impact of its use would be felt during chemotherapy and for the rest of their lives.