SBIR Phase II: Optimized Medication Administration Device for Palliative Care

这个小型企业创新研究(SBIR)第二阶段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，在口服途径受损时以成本效益的方式管理姑息药物。几乎所有的患者在濒临死亡时都会丧失吞咽能力。大约10%-20%的临终关怀患者在口服途径不再起作用后会出现严重的症状。不幸的是，这些患者中的大多数要么痛苦地死去，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，并每年花费医疗保健系统数亿美元。在美国，每年大约有170万名患者在临终关怀中心。近30%的医疗保险资金是在生命的最后一年花费的。一种实现低视力护理的方法，为患者提供有效的症状控制？S之家可以每年减少5亿多美元的医疗保险临终关怀福利成本。更重要的是，它将使患者能够在生命的最后宝贵日子里，有尊严地留在家里。这个项目的成功实施还将带来一个可行的医疗设备业务，这将创造数十个新的就业机会，并得到数百万美元收入的支持。拟议的项目旨在开发一种优化版本的直肠给药装置，该装置可以由外行人放置，患者感到舒适。直肠血管丰富，吸收迅速有效。直肠远端1/3部分绕过肝门静脉，使得药物可以进入中心静脉系统，而不会第一次通过肝脏。直肠途径不存在经皮给药的并发症风险或费用。将进行药代动力学研究，比较通过微量灌肠和栓剂给药的姑息性药物的全身吸收。由于重复插入的不适和尴尬，以及与以栓剂形式获得药物相关的等待时间和成本，栓剂是一种不受欢迎的直接给药方式。在成功完成第二阶段工作后，优化设备的原型将完成，并在与非专业志愿者进行的可用性研究中进行易用性验证。拟议项目的目的是使直肠给药途径切实可行，从而为向更广泛的患者群体介绍其益处奠定基础。

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.