Innovative Device to Improve Safety of Preparing and Administering Chemotherapy

描述(申请人提供)：用于癌症化疗的药物往往具有高度的细胞毒性和遗传毒性，具有良好的致癌、致突变和致畸作用。长期职业性接触这些剧毒药物会给经常准备和实施化疗的医护人员带来严重的健康风险，如癌症、不孕不育、流产、出生缺陷、自然流产和先天性畸形。在配制药物并给患者服用的过程中，任何几个步骤都可能发生液体、微粒或蒸汽形式的泄漏，几项研究表明，工作场所污染的可能性很大。封闭式系统传输设备(CSTD)最初是为了降低这些风险而开发的，但目前市场上可用的设备存在许多缺点，包括泄漏、针头卡住、效率低下、使用困难和反复应激损伤。这项第一阶段SBIR提案的目标是测试一种新的、创新的一次性CSTD设计的可行性，该设计具有提供卓越的药物遏制能力的潜力。可行性将通过追求两个具体目标来确定。在目标1中，这一独特的概念将通过与快速原型的制造和测试相关的一系列设计迭代来提炼，最终生产出一个概念验证的工作原型，该原型可以在目标2中进行严格的测试以确定其性能特征。工作原型的性能将在真实的过程模拟条件下进行验证，以确定它是否能够在药物配制过程中遇到的最具挑战性和压力的条件下，在操作过程中遏制泄漏并保持无菌。密封性将通过敏感的目测和分析方法进行测量，无菌将使用美国药典关于介质填充的标准来确定。第一阶段设计和开发研究的成功完成将为这种新型的一次性CSTD奠定基础，成为一项颠覆性技术的基石，该技术将在第二阶段得到进一步开发。随着人口老龄化和癌症患者数量的增加，对化疗药物复合的需求预计将增加，特别是为护理点使用的定制疗法的准备。这项提案中描述的独特方法将通过降低职业暴露的风险和提高患者用药的准确性，同时提高效率和降低成本，使医护人员和患者都受益。我们预计，我们的创新CSTD将带来前所未有的安全性和效率改进，从战略上定位强生，以利用快速增长的5亿美元市场，同时降低与合成和管理危险化疗药物相关的风险。 公共卫生相关性：数百万医护人员在药物准备和给药过程中面临接触危险药物的风险，例如用于治疗癌症患者的化疗药物。封闭式系统转移装置(CSTD)最初是为了保护工人免受接触剧毒药物的危害而开发的，但目前的装置有几个缺点。该提案描述了一种新型一次性CSTD的创新设计和方法，该设计和方法将通过限制这些危险药物的释放到工作环境中来实现对医护人员和癌症患者的更好保护。

DESCRIPTION (provided by applicant): Drugs used for cancer chemotherapy tend to be highly cytotoxic and genotoxic, with well-documented carcinogenic, mutagenic, and teratogenic effects. Long-term, occupational exposure to these highly toxic drugs presents serious health risks to the healthcare personnel who routinely prepare and administer chemotherapy, such as cancers, infertility, miscarriages, birth defects, spontaneous abortions, and congenital malformations. Leakage in the form of liquid, particulate, or vapor can occur during any of several steps in the process of compounding the drug and administering it to the patient, and several studies suggest the potential for workplace contamination is widespread. Closed system transfer devices (CSTDs) were originally developed to mitigate these risks, but the devices that are currently available in the marketplace suffer from a number of shortcomings, including leakage, needle sticks, inefficiencies, difficulty of use, and repetitive stress injuries. The objective of this Phase I SBIR proposal is to test the feasibility of a new, innovative disposable CSTD design that has the potential to provide superior drug containment capabilities. Feasibility will be determined by pursuing two specific aims. In Aim 1, this unique concept will be refined through a series of design iterations linked to fabrication and testing of rapid prototypes, culminating in production of a proof-of concept, working prototype that can be rigorously tested to establish its performance characteristics in Aim 2. Performance of the working prototype will be validated under real-life, process simulation conditions to determine whether it can contain leakage and maintain sterility during operation under the most challenging and stressful conditions encountered during drug compounding. Containment will be measured by sensitive visual and analytical methods, and sterility will be determined using United States Pharmacopeia standards for media fill. Successful completion of the phase I design and development studies will establish the groundwork for this novel, disposable CSTD as the cornerstone of a disruptive technology that will undergo further development in Phase II. As the population ages and the number of cancer patients grows, the demand for chemotherapy drug compounding is expected to increase, especially the preparation of tailored therapies for point-of-care use. The unique approach described in this proposal will benefit healthcare staff and patients alike by reducing the risks of occupational exposure and improving the accuracy of patient medications, while simultaneously increasing efficiencies and reducing costs. We anticipate our innovative CSTD will introduce unprecedented safety and efficiency improvements, strategically positioning J&J to capitalize on a rapidly growing $500 million market while reducing the risks associated with compounding and administering hazardous chemotherapy drugs. PUBLIC HEALTH RELEVANCE: Millions of healthcare workers are at risk of exposure to hazardous drugs, such as chemotherapeutics used to treat cancer patients, during drug preparation and administration. Closed system transfer devices (CSTDs) were originally developed with the goal of protecting workers from the hazards of exposure to highly toxic drugs, but current devices have several shortcomings. This proposal describes an innovative design and approach for a new type of disposable CSTD that will provide better protection for healthcare workers and cancer patients alike, achieved by limiting the release of these hazardous drugs into the work environment.