SBIR Phase I: Rectal Medical Administration Device with Non-Clogging Ports

该小型企业创新研究（SBIR）第一阶段项目旨在开发一种创新，提供持续的，微创的，谨慎的药物输送到直肠的远端1/3。该项目是针对开发一个优化的设计和原型的直肠给药装置（RMAD）。 几乎所有的病人在濒临死亡时都会失去吞咽能力。大约10%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。 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。直肠医疗管理是一个很好的，但未充分利用的方式，由于缺乏一个简单的，谨慎的，舒适的交付选择。直肠给药装置将解决直肠给药的所有这些问题。该项目更广泛的影响/商业潜力超出了临终关怀和姑息治疗的范围。例如，可以想到的是，该装置可以在各种紧急情况下用于水合和药物输送，癫痫控制是一个示例。每一辆救护车、军医或特种部队士兵都可能携带一个用于药物输送或水合作用。 它可能用于保留灌肠的管理，以减轻便秘患者，用于严重肠道感染的抗生素管理，以及许多其他应用。患有严重恶心和呕吐的化疗癌症患者可以在家中使用该设备进行抗恶心药物输送。 很明显，临终关怀和姑息治疗领域的进步非常重要。 2009年，美国有160万病人在临终关怀中心，每年增长11%。近30%的医疗保险资金用于生命的最后一年。RMAD有可能每年减少超过5亿美元的医院成本。 由Hospi公司开发的直肠给药装置将在美国和全世界的临终关怀竞技场以及更远的地方具有深远的人道主义和经济利益。

This Small Business Innovation Research (SBIR) Phase I project is aimed at the development of an innovation which provides for ongoing, minimally invasive, discreet delivery of medications to the distal 1/3 of the rectum. The project is directed toward developing an optimized design and prototype of a rectal medication administration device (RMAD). Almost all patients lose the ability to swallow as they near death. Approximately 10% 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. 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. Rectal medical administration is an excellent, yet underutilized modality due to lack of an easy, discreet, and comfortable delivery option. The rectal medication administration device will solve all of these current problems with rectal medication delivery.The broader impact/commercial potential of this project goes beyond the scope of hospice and palliative care. For example, it is conceivable that the device could be used in various emergency situations for hydration and medication delivery, seizure control being one example. It is possible that every ambulance, military medic, or special-forces soldier could carry one for medication delivery or hydration. It would likely be used for the administration of retention enemas to relieve constipated patients, for administration of antibiotics for severe bowel infections, and numerous other applications. Cancer patients undergoing chemotherapy with severe nausea and vomiting could use the device for anti-nausea medication delivery at home. It is clear that advances in the field of hospice and palliative care are very important. In 2009 there were 1.6M patients in hospice in the US, growing at 11% per year. Close to 30% of Medicare dollars are spent in the last year of life. The RMAD has the potential to reduce hospital costs by over $500 million annually. The development of the rectal medication administration device by Hospi Corporation will have profound humanitarian and financial benefits both within the US and worldwide within the hospice arena and well beyond.