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.
The efforts of this SBIR grant have been directed toward the development of a rectal medication administration device (RMAD) with clogging resistant ports. The rectal route of medication administration is a physiologically favorable alternative when the oral route is compromised, but is underutilized due to practical limitations. The rectal route is particularly relevant near the end of life, when all patients lose the ability to swallow, but over 20% have symptoms requiring continued management. An optimized rectal access device that enables easy, comfortable, and discreet administration of rectal medication can have a significant impact on patients, caregivers, and payers. Medicare (i.e. CMS) can save over $1B per year if high acuity hospice days can be transformed into routine care days. The efforts have been successful in that all major technical objectives proposed have been met. The RMAD has been designed, fabricated, and tested to demonstrate non-clogging properties. The device was also designed and mechanically characterized to ensure that it could not generate unsafe forces in the rectum. The scope of the project was expanded with a Phase 1b extension to develop a pill crusher that facilitates the preparation of suspensions from medications in pill or tablet form. Existing pill crushers can generate large particles that can challenge the clogging resistant properties of the RMAD. These existing pill crushers also do nothing to facilitate the workflow of suspension preparation and administration. Therefore, an accessory to the RMAD that optimizes suspension preparation was designed and successfully tested.
