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

这个小型企业创新研究(SBIR)第一阶段项目旨在开发一种创新，提供持续、微创、谨慎的药物输送到直肠的远端1/3。该项目旨在开发直肠给药装置(RMAD)的优化设计和原型。几乎所有的患者在濒临死亡时都会丧失吞咽能力。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。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。直肠给药是一种很好的方式，但由于缺乏简单、谨慎和舒适的分娩方式而未得到充分利用。直肠给药装置将解决目前直肠给药的所有问题。该项目的更广泛影响/商业潜力超出了临终关怀和姑息治疗的范围。例如，可以想象，该设备可以用于各种紧急情况下的水合和药物输送，癫痫控制就是一个例子。每一辆救护车、军医或特种部队士兵都有可能携带一辆这样的车，用于运送药物或补充水分。它可能被用于给药保留灌肠以缓解便秘患者，用于给药抗生素治疗严重的肠道感染，以及许多其他应用。癌症患者在接受化疗时有严重的恶心和呕吐，可以在家中使用该设备进行抗恶心药物输送。显然，临终关怀和姑息治疗领域的进展非常重要。2009年，美国有160万名临终关怀患者，以每年11%的速度增长。近30%的医疗保险资金是在生命的最后一年花费的。RMAD有可能每年减少超过5亿美元的医院成本。赫米公司开发的直肠给药设备将在美国和世界范围内的临终关怀领域和更远的地方产生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.