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Revive Adrenaline Auto-injector: Industrial Research

Revive Adrenaline Auto-injector: Industrial Research
Revive 肾上腺素自动注射器:工业研究
批准号:
10028104
负责人:
金额:
$74.41万
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2022
资助国家:
英国
项目状态:
已结题
起止时间:
2022 至 --

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中文摘要
翻译
肾上腺素自动注射器(AAI)是给那些容易患严重过敏症的人开的,严重过敏症会使他们面临过敏反应的风险--一种危及生命的过敏反应。尽管医疗建议随身携带注射器的人在任何时候,我们的用户研究表明:1。人们不携带他们几乎一样多,他们应该2。由于肾上腺素是已知的唯一可预防过敏性反应导致死亡的药物,因此未接受肾上腺素治疗过敏性反应是死亡的最大常见因素3。妇女是一个关键的关注领域,因为目前的针头长度不能保证肌内分娩在这一患者群体复兴是一个新的AAI概念,作为毕业项目在皇家艺术学院(RCA)开发。在2020年1月Innovate UK Smart Grant中成功实现Revive自动注射器的技术可行性后,我们可以在实验室规模开展实验评估活动,评估概念验证和安全性,并在该拟议项目中探索潜在的生产机制。本项目提案旨在确认初步符合AAI的监管要求,并将特别关注供应链(实验室规模模型中容器密封完整性的无菌灌装和加塞概念验证)。我们还将进行一项用户研究,以量化我们的设备与现有产品相比的相对增长。设计以患者为中心,其信用卡大小使其易于携带,其形式使其谨慎地适合患者的生活。这些联合收割机以前所未有的方式结合起来,以抵消已确定的过大而实际上无法连续承载的问题。与目前市场上的大多数产品不同,Revive采用了英国复苏理事会推荐的更长针头指南,以减少过敏管理系统中的性别差异。Revive通过重新检查注射器应如何设计用于AAI来实现这一点。专有的针头注射系统概念已获得InnovationRCA的支持,并正在英国申请专利(知识产权局已将申请转为授予)。该公司目前正在InnovationRCA孵化,Medcity的试点社区计划和NHS创新服务Beta计划的一部分。它得到了《标准晚报》和《蓝图》杂志的宣传,也得到了全球格拉德展、英国发明展和胚胎风险投资公司的支持。
英文摘要
An adrenaline auto-injector (AAI) is prescribed to people who are susceptible to severe allergies that put them at risk of anaphylaxis -- a life threatening allergic reaction. Despite medical advice to carry the injector on person at all times, our user studies show:1. People do not carry them nearly as much as they should2. Not receiving adrenaline for an anaphylactic reaction is the biggest common factor in fatalities as adrenaline is the only drug known to prevent death due to anaphylaxis3. Women are a key area of concern as current needle lengths do not guarantee intramuscular delivery in this patient populationRevive is a new AAI concept developed as a graduation project at the _Royal College of Art (RCA)_. After successful technical feasibility of the Revive auto-injector in the Innovate UK Smart Grant January 2020 we can undertake activities for experimental evaluation at laboratory scale, evaluate proof of concept and safety, and explore potential production mechanisms in this proposed project. This project proposal is to validate the preliminary adherence to the regulatory requirements of an AAI and particular attention will be paid towards the supply chain (proof of concept aseptic filling and stoppering for container closure integrity in a lab-scale model). We will also conduct a user study to quantify comparative increase of our device being carried vs. existing products.Designed with the patient at its centre, its credit card size makes it easy to carry and its form makes it discreetly fit within a patient's life. These combine like never before to counteract the identified problems of being too large to practically carry continuously. Revive, unlike most current offerings in the market, incorporates the UK Resuscitation Council's recommended guidelines for a longer needle to reduce the gender disparity in allergy management systems. Revive achieves this through a fresh examination of how a syringe should be designed for an AAI. The proprietary needle injection system concept has been awarded InnovationRCA's support and is patent pending in the UK (Intellectual property office has moved application towards grant).The company is currently incubated at InnovationRCA, Medcity's Pilot Community Program and part of NHS Innovation Service Beta program. It has received publicity from _The Evening Standard_ & _Blueprint magazine_ and also won support from the Global Grad Show, British Invention Show and Embryo Ventures.
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