SBIR Phase II: Optimized Medication Administration Device for Palliative Care

SBIR 第二阶段：用于姑息治疗的优化药物管理设备

• 批准号: 1431026
• 负责人: Igal Ladabaum
• 金额: $ 69.69万
• 依托单位: Hospi Corporation
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-11-15 至 2018-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1431026&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Optimized; Medication

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a clinically effective and discreet way to administer palliative medications cost effectively when the oral route is compromised. Almost all patients lose the ability to swallow as they near death. Approximately 10%-20% of hospice patients have severe symptoms after the oral route is no longer functional. Unfortunately most of these patients either die uncomfortably, or are admitted to the hospital for symptom control. These outcomes are tragic for the patient, and cost the healthcare system hundreds of millions annually. There are approximately 1.7M patients in hospice in the US per year. Close to 30% of Medicare dollars are spent in the last year of life. An approach enabling low acuity care that provides effective symptom control in the patient?s home can reduce Medicare hospice benefit costs by over $500 million annually. More importantly, it would enable patients to remain in their homes, with dignity, during the last precious days of life. Successful execution of this project would also result in a viable medical device business that would create dozens of new jobs supported by multi-million dollar revenues. The proposed project is directed toward developing an optimized version of a rectal medication administration device that can be placed by a layperson and is comfortable for the patient. The rectum is highly vascularized for rapid and effective absorption. The distal 1/3 of the rectum partially bypasses the hepatic portal vein allowing medication to enter the central venous system without a first pass effect through the liver. The rectal route does not have the complication risks or the cost of percutaneous medication administration. A pharmacokinetic study will be performed to compare the systemic absorption of palliative medication administered via micro-enema to the absorption via suppository. Suppositories are an undesirable way to administer ongoing medications rectally due to the discomfort and embarrassment of repeated insertions, as well as the wait time and cost associated with procuring medications in suppository form. Upon successful completion of Phase II work, prototypes of optimized devices will be complete and validated for ease of use in a usability study with layperson volunteers. The aim of the proposed project is to make the rectal route of medication administration practical, and thus set the stage to introduce its benefits to a broad segment of the patient population.

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是提供一种临床有效和谨慎的方式，在口服途径受到影响时，以经济有效的方式给予姑息性药物。 几乎所有的病人在濒临死亡时都会失去吞咽能力。大约10%-20%的临终关怀患者在口服途径不再起作用后出现严重症状。不幸的是，这些患者中的大多数要么不舒服地死去，要么被送进医院进行症状控制。 这些结果对患者来说是悲惨的，每年花费医疗保健系统数亿美元。美国每年约有170万病人在临终关怀中心。近30%的医疗保险资金用于生命的最后一年。一种方法，使低敏度护理，提供有效的症状控制的病人？的家每年可以减少超过5亿美元的医疗临终关怀福利费用。 更重要的是，它将使病人在生命最后宝贵的日子里有尊严地留在家中。 该项目的成功执行还将导致一个可行的医疗器械业务，这将创造数十个新的就业机会，并获得数百万美元的收入。 所提出的项目是针对开发一种优化版本的直肠给药装置，可以由外行放置，并为患者感到舒适。 直肠血管发达，便于快速有效地吸收。直肠的远端1/3部分绕过肝门静脉，允许药物进入中心静脉系统，而没有通过肝脏的首过效应。直肠途径没有并发症风险或经皮给药的成本。 将进行药代动力学研究，以比较通过微型灌肠剂给药的姑息药物的全身吸收与通过栓剂给药的吸收。由于反复插入的不适和尴尬，以及与获得栓剂形式的药物相关的等待时间和成本，栓剂是直肠施用持续药物的不期望的方式。 在成功完成第二阶段工作后，将完成优化器械的原型，并在非专业志愿者的可用性研究中验证其易用性。拟议项目的目的是使直肠给药途径切实可行，从而为向广大患者群体介绍其益处奠定基础。