Almost all patients lose the ability to swallow at some point as they near death. During this time, symptom management can become more difficult, as symptoms such as pain, dyspnea, nausea, and agitation tend to worsen. 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 their loved ones, and cost the healthcare system hundreds of millions annually. Improved technology for the management of symptoms and end of life care are both integral parts of the NINR mission. Hospi Corporation is developing a device that will effectively manage symptoms in this patient population and allow for peaceful, dignified death at home. Rectal medical administration is an excellent, yet underutilized modality due to lack of easy, discrete, and comfortable delivery options. The rectal mucosa is highly vascularized tissue evolved for rapid and effective absorption, and 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. This Phase I SBIR project is directed toward developing an optimized design and prototype of a rectal medication administration device (RMAD). Upon successful execution of Phase I work, biocompatible prototypes for subsequent use in humans will be complete. A Phase II proposal is planned to validate the effective rectal absorption of palliative medications in healthy volunteers using the prototypes built and tested in Phase I. The Phase I program will produce an RMAD with a safe retention balloon made of demonstrated biocompatible materials and processes, and will incorporate human factors design philosophy to ensure patient comfort, ease of insertion by a trained hospice nurse and simple subsequent medication administration by caregivers. Advancements in the field of hospice and palliative care are very important. In 2010 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. By developing an easy to use, effective, and comfortable liquid delivery device capable of dispersing and retaining physician prescribed medication in the rectum, Hospi Corporation will provide profound humanitarian and financial benefits.

Public Health Relevance

Because significant suffering and healthcare expenses are incurred near the end of life, innovation in the field of hospice and palliative care that assists o manage symptoms and decrease health care costs is very important. Approximately 10% of hospice patients can no longer swallow medications due to mental or physical decline yet have severe symptoms such as pain, nausea, respiratory distress, or agitation, and many die uncomfortably or are admitted to the hospital. The rectal medication administration device proposed in this research can control symptoms in these patients, allowing them to die peaceful deaths in their own homes, while saving $500M in hospital admissions annually.

National Institute of Health (NIH)
National Institute of Nursing Research (NINR)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-SBIB-Q (11))
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Cotton, Paul
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Hospi Corporation
United States
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