This Small Business Innovation Research (SBIR) Phase I project proposes to develop a mobile, easy-to-use, patient oriented, advanced Home Hemodialysis (HD) system that minimizes the use of water and medical wastes, and importantly, minimizes loss of nutrients. End-stage renal disease (ESRD) is a devastating and disabling disease requiring chronic dialysis treatment, which severely limits the mobility and quality of life (QOL) of ESRD patients and their caregivers due to the time and effort required to receive treatment. At dialysis centers, standard hemodialysis treatment, which utilizes massive amounts of highly purified water, results in a significant loss of nutrients. The objectives of this Phase I project are to design and test key units of an HD machine (HDM), to test the efficacy and safety of the system in vitro and to design a light weight (~22 kg) prototype home HD system equipped with high precision components for in vivo studies. Using minimum dialysate (<6L), the developed home HD system will achieve adequate toxin clearance with minimal ion and serum albumin loss, greatly improving the QOL of ESRD patients and their families by allowing for effective and comfortable treatment at home, work, or school or during travel.
The broader impact/commercial potential of this project includes reducing the economic burden of end-stage renal disease (ESRD) on patients and Federal healthcare programs. As the number of ESRD patients approaches 3 million globally, it is becoming critical to decrease the cost and resource burden of the chronic dialysis treatment of these patients by drastically decreasing facility costs, use of water and energy in treatment, and to increase patients' quality of life by facilitating greater flexibility in length and place of treatment. The proposed semi-portable hemodialysis machine offers many advantages over currently available dialysis systems. The advantages are based on both the highly efficient dialysis regeneration capability and the light-weight, precisely configured and controlled machine. The savings in raw water costs alone from use of this HD system would be significant. The savings could be even greater in other parts of the world where water costs are significantly higher (i.e. Germany, Great Britain, etc.) and where access to clean water is becoming increasingly difficult (i.e. China, India, Mexico, etc.). The system will enhance the scientific and technical knowledge in the fields of dialysis and sorbent technologies.
Project Outcomes/Findings This Small Business Innovation Research Phase I project focused on the development of an advanced, mobile, easy-to-use, patient-oriented Home Hemodialysis (HD) system which minimizes the use of water (less than 6 liters), medical waste, and importantly, loss of nutrients from patients. End-stage renal disease (ESRD) is a devastating disability. Many ESRD patients and their families are severely limited in their mobility and freedom of life due to the time and effort involved in having life-sustaining hemodialysis treatments at hospitals and dialysis centers; severe depression is commonly observed among both patients and family members. Home hemodialysis options can vastly improve these outcomes. Our ultimate goal is to develop a next generation, lightweight hemodialysis machine (~22 kg) equipped with high precision components and an innovative dialysate regeneration system. The objective of this Phase I program was to design a highly efficient, compact hemodialysis machine with minimal weight and superior safety features, identify or construct the key components required and establish the best configuration of the key components for optimal performance. Through this Phase I study, we demonstrated the feasibility of our goals by achieving the overall key measurements of success in this program and concluded that our synthesized system will lead us to the successful construction of a new type of lightweight, compact HD machine equipped with top-rated safety devices that is suitable for treatment of ESRD patients at home, work and school. Intellectual Merit. The advantages of our hemodialysis system are based on both the highly efficient and selective dialysate regeneration system, composed of a specifically functionalized sorbent, and the compact and highly efficient dialysis machine that allows for a well-configured and accurately controlled dialysis treatment. The system will significantly enhance the scientific and technical knowledge in the fields of dialysis and sorbent technologies. This system will also minimize use of drugs and nutrient infusion, the cost of which can exceed that of all other dialysis products used during treatment. Therefore, this product will provide a next generation dialysis treatment with decreased cost as well as great enhancement in the quality of life (QOL) for patients. The Broader Impact/Commercial Potential of the Proposed Activity. The proposed mobile (semi-portable) hemodialysis machine equipped with Chemica’s dialysate regeneration system offers many advantages over currently available dialysis systems. As the number of chronic dialysis patients approaches 3 million globally, it is becoming critical to decrease the cost and resource burden of treating these patients by drastically decreasing facility costs, use of water and energy in treatment, and to increase patients’ QOL by facilitating greater flexibility in the length and place of treatment (home, school, work). This system also allows for the personalized dialysis treatment of patients through selective adsorption of toxins. Again, given the flexibility in dialysis treatment, the QOL of dialysis patients and their families will be greatly enhanced. Further, this technology will reduce the overall cost of dialysis treatment by minimizing the use of water, a critical resource that is becoming increasingly expensive every year, and decreasing the need for administration of nutrients and drugs, as well as minimizing the various direct and indirect hospital costs, all resulting in a reduced economic burden on dialysis patients and government-funded healthcare programs worldwide. .
