SBIR Phase II: Optimized Medication Administration Device for Palliative Care

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是提供一种临床有效和谨慎的方法，在口服途径受到损害时，以经济有效的方式给药缓和药物。几乎所有病人在濒死时都失去了吞咽的能力。大约10%-20%的安宁疗护病人在口服途径不再有效后出现严重症状。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剧性的，并且每年花费医疗保健系统数亿美元。在美国，每年大约有170万病人接受临终关怀。将近30%的医疗保险资金花在生命的最后一年。一种能够有效控制患者症状的低敏锐度护理方法？他的家每年可以减少医疗保险临终关怀福利费用超过5亿美元。更重要的是，它将使病人能够在生命的最后宝贵日子里有尊严地呆在家里。这个项目的成功执行也将导致一个可行的医疗设备业务，将创造几十个新的就业机会，由数百万美元的收入支持。拟议的项目旨在开发一种优化版本的直肠给药装置，可以由外行人放置，并且对患者来说很舒服。直肠血管密布，吸收迅速有效。直肠远端1/3部分绕过肝门静脉，允许药物进入中心静脉系统，而无需通过肝脏的首次通过效应。直肠途径没有并发症风险或经皮给药的费用。将进行药代动力学研究，以比较通过微灌肠和栓剂给予的缓和药物的全身吸收。栓剂是一种不可取的方式来给药正在进行的直肠由于不适和尴尬的反复插入，以及等待时间和成本与获取栓剂形式的药物。在成功完成第二阶段的工作后，优化设备的原型将完成，并在外行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，从而为将其益处介绍给广大患者群体奠定基础。

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.