Research & Projects
The Biodesign Laboratory is a highly experienced medical device laboratory. Lab research spans several foci, including developing an implantable artificial kidney within The Kidney Project; medical devices designed with a child’s specifications in mind within the Pediatric Device Consortium; and several other stand-alone device projects. Lab members collaborate frequently with other scientists at UC San Francisco and engineers at UC Berkeley, as well as medical specialists including nephrologists, surgeons, and radiologists.
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The Kidney Project is a national research project, based at UCSF and directed by Shuvo Roy, creating a small, surgically implanted, free-standing bioartificial kidney to treat end stage renal disease (ESRD). The bioartificial kidney will give ESRD patients new hope beyond the short-term solution of renal dialysis and the longer-term, but impermanent, solution of a living kidney transplant for which donor organs are limited. In addition, the bioartificial kidney is expected to save significant national health care dollars.
The bioartificial kidney comprises two components: a hemofilter and a bioreactor. For the hemofilter, the lab is using MEMS technology in the production of silicon nanopore membranes (SNMs) which will perform filtration using the body’s blood pressure. The bioreactor will reabsorb a high volume of salt and water while maintaining a barrier to the reabsorption of toxins. To do this, the lab is using tissue engineering techniques to grow and maintain renal tubules that will be seeded into this portion of the device.
The Biodesign Laboratory works in close partnership with Vanderbilt University, where William Fissell, MD, oversees the medical aspects of the device. Other collaborators include scientists at Cleveland Clinic, The Ohio State University, Pennsylvania State University, University of Michigan, and Case Western Reserve University. To learn more, including the development timeline and FAQs, visit The Kidney Project.
The Pediatric Device Consortium (PDC) aids in developing devices that are created specifically for the benefit of children, rather than scaled-down versions of adult medical devices. The PDC brings innovators and entrepreneurs together with physicians, engineers, and designers to provide advice, experience, and technical support to individuals and groups who are working to create medical devices for children. Through their two full-time staff engineers as well as a wide network of device professionals, the PDC can help with patent and regulatory information, electrical and biomechanical consulting, cadaver and device testing, and legal and business insight.
The PDC is currently working on seven device projects:
- Implantable bioartificial kidney to treat acute renal failure in children
- Dynamic Compressor to treat pectus carinatum
- MAGIC Magnetic Retractor for performing complex pediatric laparoscopic procedures
- Magnamosis to treat congenital gastrointestinal anomalies
- Magnap to treat obstructive sleep apnea
- Magnetic Mini-Mover to treat pectus excavatum
- Roboimplant to treat early onset scoliosis
The PDC is funded by a grant from the U.S. Food and Drug Administration (FDA). For more information on their projects and meeting schedule, visit Pediatric Device Consortium.
Each year, 15 million babies around the world are born preterm. Over one million of these preterm infants die, making preterm birth the leading cause of newborn deaths. Current detection methods such as transvaginal ultrasound and fetal fibronectin are used to monitor high-risk pregnancies, but they cannot predict if a preterm birth will occur. The Smart Diaphragm is a wireless, intravaginal device developed by the UCSF Biodesign Laboratory that monitors fluorescence and impedance of cervical tissue during pregnancy to detect early signs of preterm birth.
Research stage: Phase I clinical study at UCSF
The Biodesign Laboratory supports research in many smaller-scale device projects. Most projects are driven by graduate students and staff engineers, showcasing the diversity and innovation within the lab. Among these projects are:
Development of bioartificial pancreas using silicon nanopore membranes (SNMs) for the treatment of Type 1 Diabetes (T1D)
More than 25 million people have been diagnosed with diabetes in the United States. Type I diabetes is an autoimmune disease in which the insulin-producing beta cells in the islet cells of the pancreas are destroyed by the body’s immune system. Current treatment methods are inadequate: insulin therapy is cumbersome; pancreas transplant requires an organ donor match and immunosuppressant drugs. Silicon nanopore membranes (SNMs) developed by the Biodesign Laboratory have shown unprecedented permselectivity with great biocompatibility and durability. The bioartificial pancreas project focuses on using SNMs as immunoisolation barriers to protect transplant islets from pro-inflammatory attack.
Research stage: Proof of concept
High-efficiency gas exchange membranes for extracorporeal membrane oxygenation (ECMO)
ECMO is a life support modality that acts as an artificial lung when a patient’s lungs are diseased or injured. Using silicon nanopore membranes (SNMs) coated with a micron-thin film of siloxane polymer, we are developing a planar gas exchange membrane to rapidly transport oxygen into the blood stream while removing carbon dioxide. This will enable the design of more compact oxygenators, allowing patients with respiratory failure to remain ambulatory while awaiting a lung transplant or convalescing from injury.
Research stage: Proof of concept
As technology and medicine continue to advance, more devices are developed to monitor patient data and allow patients to track their health more easily. The lab supports several such projects:
- HeartPulse is a home bathroom scale for monitoring heart failure at home.
Stage: Human research study
- SmartDerm is a wound dressing that can detect early formation of pressure ulcers.
Stage: Human research study
- SwigSmart is a pervasive hydration tracking system for kidney and heart failure patients, nursing moms, and health enthusiasts.