Surgical Innovations' Accelerator program awards seed funding for viable medical device ideas from Department of Surgery innovators through a bi-annual RFP process. We are excited to announce the first two rounds of projects supported through our Accelerator program, described below.
The next call for proposals will be announced in the Summer of 2016 and we encourage you to consider applying. If you have an idea that you would like to run by our team, please complete our project consultation form.
Fall 2015 Accelerator Projects
Roboimplant: A Non-Invasively Expandable Implanted Rod for Orthopedic Surgery
Principal Investigator: Michael R. Harrison, M.D.
The science of bone healing is limited by our present inability to measure biological and physical parameters affecting bone growth in real time. The treatment of bone injuries and musculoskeletal disorders stands to be advanced by the integration of sensing technology into orthopedic devices. The Roboimplant is a magnetically activated expandable intramedullary rod that can be non-invasively controlled and measure and influence bone healing in real time. Coupled with an external remote controller, the system will create a full feedback loop for the treating physician, providing real time data on bone quality and growth and enabling non-invasive adjustments to the treatment course based on data from the implant. This new device has the potential to improve the treatment of all patients affected by orthopedic trauma or skeletal deformity and would decrease the risk of infection by virtue of its placement inside the bone, as opposed to current practice which relies on external fixators or multiple surgeries to adjust the rod.
Sentinel Bandage: Monitoring Wounds with Non-Invasive Impedance Mapping
Principal Investigator: David M. Young, M.D.
Every year over 1.8 million new patients develop problematic wounds that require prolonged treatment at specialized wound care clinics in the United States. Monitoring the health of the wound remains the most common challenge for both the clinician and patient. A bandage to track whether a wound is improving or deteriorating allows clinicians to guide treatment accordingly and also offers a greater sense of safety to patients. Using impedance spectroscopy, the Sentinel Bandage maps the various stages of wound healing and monitors the health of skin and superficial soft tissue, offering improved diagnostics for a large number of patients by facilitating the treatment of their wounds. The initial two clinical applications include measuring wounds as they heal and detecting pressure ulcers (bedsores). Once fully developed the platform technology has potential for use in multiple markets.
Esophageal Manometry for Airway Protection (EMAP): Decreasing the Risk of Aspiration and Respiratory Compromise
Principal Investigator: Stanley J. Rogers, M.D.
During the early emergence from anesthesia, a patient’s aspiration risk is high as the airway protection is diminished. Post anesthesia respiratory problems are more common in patients over 50 years of age and those undergoing certain types of procedures, including upper abdominal surgery, gastrointestinal endoscopy, neurosurgery and head and neck procedures. The EMAP technology is a convenient addition to current quantitative monitoring of recovery from neuromuscular blockade which promises to reduce critical respiratory events and subsequent anesthesia malpractice claims. This safety device has the ability to detect potential problems and minimize risk and will take the guesswork out of the timing of extubation.
Redesigning the ‘Hub Cap’ to Decrease Central Line Associated Blood Stream Infections (CLABSI)
Central line-associated bloodstream infections (CLABSI), estimated to be the eighth-leading cause of death in the United States, are a preventable occurrence associated with significant morbidity, and mortality, and costs to hospitals. Current methods to minimize CLABSIs include improved hand hygiene and maintaining sterile conditions when placing the line, as well as measures to improve hygiene after the line is already in place. There are four routes via which central lines become infected, one of which is the "hub" – a connector placed at the end of the catheter lumen outside the body to facilitate connections with IV tubing, syringes etc. Since the internal lumen essentially remains in continuity with the outside environment, this design is prone to infection. This project seeks to redesign the hub to protect the internal lumen and expose it for connection only under sterile conditions.
Spring 2015 Accelerator Projects
The Lamprey: A Novel Surgical Soft Tissue Manipulation/Retraction Device
Principal Investigator: Insoo Suh, M.D.
Handling of soft tissue with instruments during surgery requires caution, as excessive forces can lead to tissue damage in the form of lacerations or crush injuries. Existing instruments apply mechanical force to tissue through a pair of metallic jaws or arms, most of which have rigid or sharp components. This issue is exacerbated in laparoscopic and minimally invasive surgical techniques, where the limited access and the restricted range of motion available to surgeons increase the difficulty in retracting tissue with minimal injury. The consequences of traumatic tissue damage can be particularly morbid when handling tumors (cancer seeding), and intestine (perforation, abdominal infection). The Lamprey Retractor is a novel surgical device with an innovative design for tissue contact and handling that provides effective tissue manipulating ability without the traumatic effects of standard surgical instruments. The Lamprey Retractor will allow surgical operations to be performed more easily and efficiently, through smaller incisions, and in a shorter amount of time as compared with current devices.
High-efficiency External Ambulatory Lung (HEAL)
Principal Investigator: Benjamin Padilla, M.D.
Extracorporeal membrane oxygenation therapy (ECMO) has improved clinical outcomes and survival rates for both adult and pediatric patients with respiratory compromise. However, current ECMO systems have several fundamental limitations: they are large and bulky, they greatly restrict patient movement, and the membranes used for gas exchange are inefficient and with high doses of anticoagulation required to overcome the high likelihood of blood clots. The High-efficiency External Ambulatory Lung (HEAL) seeks to address these issues via a novel approach in gas exchange membrane fabrication: specifically, a micron-thin film of PDMS supported by a specialized silicon microporous membrane to create an efficient and robust gas exchange membrane. The geometry of this approach minimizes stagnant blood flow zones and reduces the risk of clots, thus obviating the need for high doses of anticoagulation and risk of bleeding. This technology also enables the system to be miniaturized into a portable, wearable device, enabling greater patient movement and improved recovery times. By offering a wearable, low resistance, low volume oxygenator that does minimizes anticoagulation requirements, the HEAL has the potential to revolutionize the market for extracorporeal membrane oxygenators.
Contactless Bioimpedance Sensing for Transplant Rejection Detection and Monitoring
Every transplanted tissue and solid organ bears the risk of rejection, which can result in loss of the transplanted organ, resumption of the illness, and death. Currently, the status of transplanted organs is monitored by periodic biopsies and tracking various inflammation and rejection markers via blood tests. The ability to continuously monitor transplanted organs would enable detection of early stages of rejection, allowing for a more rapid response and the potential to maintain organ function without subsequent surgery. Our group is developing a contactless, implantable sensor that can continuously monitor transplanted tissue status. By monitoring the electrical signature of transplanted tissue, this device can identify the early signs of tissue rejection and alert clinicians, enabling rapid preventative intervention.
Getting Fit for Surgery: The b-Redy App
Principal Investigator: Emily Finlayson, M.D., M.S.
Older patients are at greater risk for complications after surgery, including delirium, loss of functional independence, and death. Recent studies suggest that older patients who receive health coaching before surgery have better postsurgical outcomes, including fewer complications, shorter hospital length of stay, and faster functional recovery. The “b-Redy App” acts as a personal health coach for older patients by actively engaging users in their efforts to get ready for surgery. The application streamlines assessment of patients’ mental and physical status and generates individualized optimization programs that coach patients through activities in preparation for surgery. By preparing patients and improving fitness before surgery, the “b-Redy App”” has the potential to help elders prepare for surgery, accelerate recovery, reduce complications, and improve outcomes in older patients after surgical procedures. See also: UCSF Center for Surgery in Older Adults (CSOA).
Endoscopic Magnetic Retractors
Principal Investigator: Matthew Y.C. Lin, M.D.
Surgical endoscopy utilizes natural orifices to access the organ of interest and enables complex procedures to be performed without an incision. Such procedures decrease postoperative pain and minimize the risk of injuring surrounding organs. While this approach offers the benefit of being minimally invasive, the size and placement of the endoscope restricts operative range of motion and limits the types of instruments available to surgeons. Currently, all endoscopic tools utilize the channels of the endoscope itself to gain access and manipulate tissue. The channels prohibit the basic operative principal of “triangulation.” To address these limitations, our team is developing an endoscopic grasping device that is deployed onto the tissue of interest via standard endoscopic techniques, but can retract independent of the movement of the endoscopic itself, creating a significantly greater range of motion. This technology has the potential to advance surgical endoscopy and enable more complex procedures to be done endoscopically.
MCAD - Magnetic Cardiac Assist Device
Principal Investigator: Neil Cambronero, M.D.
Cardiovascular disease is the leading cause of death in the United States. While up to 45,000 individuals could benefit from a heart transplant, the donor pool is only around 2,000 per year, necessitating other solutions such as Ventricular Assist Devices (VADs), or heart pumps. Since most heart pumps are in direct contact with patients’ circulating blood, infection and blood clots are ever present risks. While blood thinners can counteract the clotting risk, chronic anticoagulation in turn increases the likelihood of bleeding complications. The Magnetic Cardiac Assist Device (MCAD) takes a different approach by circumventing the blood device interface altogether and directly assisting the mechanical pumping of the heart through the innovative application of magnetic force. The MCAD avoids the need for anticoagulation therapy and does not require incisions into the heart or blood vessels in order to be placed in a patient. This device offers the potential to slow or reverse declining cardiac function and could delay or even obviate the necessity for a heart transplant in thousands of cardiac patients.
Other Active Projects
The Kidney Project: BioArtificial kidney for end stage renal disease
Principal Investigator: Shuvo Roy, Ph.D.
End stage renal disease (ESRD) is the last stage of chronic kidney disease (CKD), in which a patient experiences near complete to total kidney failure. Without functioning kidneys or proper treatment for CKD, patients reaching ESRD will die. Currently, over 650,000 Americans live with ESRD, with over 100,000 on the waiting list for available donor kidneys. Dialysis acts as a short-term treatment for patients waiting for kidney transplantation, but with a shortage of donor organs, the list of patients needing timely and costly dialysis treatments continues to grow. In addition to this clinical issue, those who live with ESRD are only 1% of the U.S. Medicare population, but account for 7% of the Medicare budget. The Kidney Project is a national research effort based at UCSF utilizing the talents of a multidisciplinary team of scientists, engineers, and clinicians to tackle ESRD by developing a surgically implanted, free-standing bioartificial kidney. Containing a hemofilter and cell bioreactor, the device acts as a natural kidney by mimicking its metabolic, endocrine, and immunological functions. Powered by blood pressure, the device eliminates the necessity for external tubes or immunosuppressant drugs. The successful development of this device has the potential to extend the lives of patients across the country and ultimately the world.
SmartDerm: Real-time monitoring & management for pressure ulcer prevention
Principal Investigator: Hanmin Lee, M.D.
Pressure ulcers, or bedsores, are a serious medical condition that occurs in 2.5 million patients annually, resulting in 60,000 deaths and a $13 billion burden to the U.S healthcare system. These sores form from pressure accumulation on bony prominences (e.g. sacrum, heels) in immobile patients leading to tissue injury, and can take months to years to heal. To address this issue, SmartDerm proposes a comprehensive pressure ulcer prevention system consisting of intelligent sensor patches that continuously collect data across multiple modalities such as pressure and oxygenation, from which machine learning algorithms predict the likelihood of ulcer formation. This information is analyzed and presented to nurses to streamline their workflow and enable data-driven intervention efforts. Eventually, this data will be used to actuate a localized, wearable automated repositioning device that continuously prevents ischemia by redistributing pressure from high risk areas, thus creating a "bundle solution" that can run in the background at hospitals, actively preventing ulcers.
Myoseal: A Novel Product for Hernia Prevention
Prinicpal Investigator: Hobart W. Harris, M.D., M.P.H.
Five million open abdominal operations are performed each year in the U.S. While most patients recover without incident, between 10% and 25% subsequently develop an incisional hernia. Beyond the cosmetic deformity, incisional hernias can lead to intestinal obstruction, bowel ischemia, enterocutaneous fistulas and significant limitations on a patient’s physical activity, overall health and well-being, and gainful employment. Consequently, there are over 400,000 incisional hernia repairs each year, making it one of the most common procedures performed by general surgeons and adding over $15 billion in annual U.S. health care costs. MYOSEAL is a disruptive technology with the potential to shift the clinical focus of surgeons, payers, and the medical device industry from incisional hernia repair to incisional hernia prevention, ultimately certifying a new standard of care for abdominal surgery. Compelling preclinical data have demonstrated that MYOSEAL, a proprietary combination of silver microparticles plus a fibrin tissue sealant, prevents incisional hernias through enhanced wound healing. Once available, it is expected that surgeons will readily adopt the prophylactic application of MYOSEAL following every open abdominal operation since the product is safe, quick and easy to use, and handles like currently available tissue sealants.
Magnap: Magnetic Treatment for Obstructive Sleep Apnea
Principal Investigator: Michael R. Harrison, M.D.
An estimated 1 in 15 people, or approximately 18-20 million adults in the United States, has at least moderate obstructive sleep apnea (OSA), a potentially serious sleep disorder characterized by repeated upper airway obstruction during sleep. Resulting in possible significant adverse effects on health and daily function, OSA is closely associated with daytime sleepiness, decreased quality of life, motor vehicle accidents, and serious cardiovascular illness, ranging from hypertension to myocardial infarction, cerebrovascular accident, and death. MagNap is a magnet-activated treatment for OSA designed to be less invasive than reconstructive surgery, more tolerable than continuous positive airway pressure (CPAP), and more effective than non-invasive therapies for OSA. The MagNap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium that is implanted on the hyoid bone in the neck via a simple surgical procedure. Following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open.
Magnamosis: Magnetic compression anastomosis device
Principal Investigator: Michael R. Harrison, M.D.
Magnamosis is a novel surgical device and method for creating an anastomosis, or connection between two tubular structures in the body, such as loops of intestine. The device consists of two donut-shaped magnets that, when introduced into adjacent sections of bowel, create a compressive force to cause necrosis in the tissue between the magnets. As the tissue between the magnets dies, the tissue around the magnets fuses to create a patent lumen between the two pieces of bowel. 2 million anastomosis procedures are performed annually worldwide, most commonly for anatomic reconstruction of disrupted intestine (due to cancer, trauma, bariatric surgery, inflammatory disease, congenital malformation, etc.). Designed to be safer, less invasive, easier to perform, and less expensive, Magnamosis offers many advantages over conventional sutures or surgical staplers and may be the enabling technology for new minimally invasive surgical procedures.
Amnioseal: Preventing premature birth in fetal intervention
Principal Investigator: Michael R. Harrison, M.D.
The burgeoning field of invasive prenatal diagnosis (amniocentesis, chorionic villus sampling) and fetal therapy (fetoscopy, fetal surgery) is limited by high rates of preterm premature rupture of membranes (PPROM) leading to preterm labor and delivery. Extensive attempts to develop biologics (fibrin glue, platelets) and devices (collagen plugs) to seal the disrupted amniotic membrane after puncture have failed. The Amnioseal project is advancing the concept of pre-sealing the amniotic membrane prior to puncture by depositing a novel bio-inspired polymer adhesive in the space between the myometrium and the amniotic membrane. Using a novel guided delivery device, the glue is deposited and the device advanced through the Amnioseal patch and adherent membrane into the amniotic space for diagnosis or therapy. When the instrument is withdrawn, the Amnioseal patch self-seals the membrane defect, preventing membrane dissection away from the uterine wall and subsequent preterm labor.
Magnetic Mini-Mover: Procedure for Pectus Excavatum
Principal Investigator: Michael R. Harrison, M.D.
Pectus excavatum is one of the most common major congenital anomalies, characterized by a deep depression of the sternum. For more than 50 years, pectus excavatum has been corrected by major surgical reconstruction through the use of either the Nuss or Ravitch procedures. Both of these procedures require major operations and hospitalization for pain management. The Magnetic Mini-Mover Procedure (3MP) is a novel minimally invasive method of correcting pectus excavatum developed in an effort to make the pectus excavatum operation better for patients and their families. With this method the deformed costal cartilages are gradually reformed by a controlled gradual outward "pull" on the depressed breastbone. This is achieved with an outpatient surgical procedure and without the need for painful implanted chest wall struts. Two magnets, one implanted inside the chest and attached to the sternum and the second one outside the chest wall and attached to an external brace, are used together to create a magnetic force field which applies a controlled sustained pull.
Otto: Digital rehabilitation device for stroke survivors
Principal Investigator: Pierre R. Theodore, M.D.
Otto designs digital rehabilitation devices that empower stroke survivors to achieve independent use of their fine motor skills.Our technology combines hardware and software elements in the form of a portable, take-home device and is meant to satisfy both the therapeutic needs of patients and the compliance and monitoring needs of clinicians. Our device's design pairs breakthrough, evidence-based principles of hand therapy with interactive and customizable software that can be incorporated into patients' daily rehabilitation routines in the comfort of their homes.