Past Projects

1/17/12 Dr. Susan Shore, Associate Professor of Otolaryngology, in her research lab.

 
The following are a list of all projects funded in the past funding cycles. Some are still ongoing as start-ups or university projects. The average award for the following projects is $113,300.

Funded Projects


2015 - 2016 Funded Projects:

  • Patients with advanced heart failure have limited options due to a limited donor heart supply. The most promising alternative to transplantation has been implantable left ventricular assist devices (LVAD). However, one of the major limitations with the current generation of LVAD is the need for a percutaneous lead that traverses the skin to connect the internal pump with the external power source.

    Francis Pagani MD, Roberto Merlin Ph.D. and their colleagues John Whitaker Ph.D., Anthony Grbic Ph.D., Jon Ameel, and Steve Young have teamed up to develop a method of wireless charging powerful enough to charge an implanted LVAD device, eliminating the need to leave wires running through a patient’s skin indefinitely.

    While wireless charging technology is not brand new, LVADs present a particular challenge because of high power requirements, potential for heating which is not tolerated by the body, and electromagnetic interference. Conventional coupled loops required for electric energy transfer cannot meet these challenges because the body poses restraints on size of loops, the working distance and the amount of shielding possible. The Xondas team have developed a near field plate technology that allows the control of magnetic fields with greater precision, and are therefore able to reduce heating and electromagnetic interference.

    In addition to significantly improving the quality of life for patients with LVAD devices, this technology is likely to significantly increase adoption of this therapy and benefit a larger number of patients with advanced heart failure. This year of Coulter funding is dedicated to working out the parameters necessary to transfer the Xondas technology form lab to a commercially viable system that can demonstrate the necessary performance criteria for use in people. LVADs are a particularly challenging use case for wireless transmission of energy, however once established the technology can readily be applied to the wireless charging of other implantable devices.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/3679_method-and-apparatus-for-sub-wavelength-near-field-focusing-of-electromagnetic-waves or email Thomas Marten (tmarten@umich.edu) for more information.

  • Every day in the US, 507 people lose a limb; while, 1000 children per year are born with limb defects. The use of prosthetic devices may determine whether persons with amputations return to work. Advanced prosthetic limbs now provide motorized joints with fine controls and sensorization similar to normal limbs (e.g. iLimb). However, the reliability of methods to control these limbs suffers from lack of suitable transduction of natural signals. Residual peripheral nerves continue to naturally conduct native control and sensation signals through their pathways that are anatomically understood. Current methods for controlling prostheses include capturing muscle signals with skin surface electrodes or capturing nerve signals with nerve cuff electrodes or nerve implanted wire electrodes. These three methods have problems because signals lack clarity, reliability, and amplitude. These interfacing methods are not intuitively based on the anatomical nerve functions.  Thus users are trained over 6 to 9 months to continually anticipate how activation of one body area will make the prosthetic device move.

     
     

    Cindy Chestek, Ph.D., collaborating with Paul Cederna, MD, and Melanie Urbanchek, Ph.D., with their colleagues developed the Regenerative Peripheral Nerve Interface (RPNI) as a method of recording signals that are two orders of magnitude larger than signals recorded from nerve fascicles. This is done by grafting small pieces of autologous muscle tissue to the ends of residual nerves. The muscle becomes reinnervated and then acts as an amplifier for the nerve signals. The amplified signals are then detected by a small implantable device then precisely records the signals sent through only the connected nerve fascicle. Receivers that translate the recorded signals and interface with a prosthetic device are housed within the prosthetic socket.  Thus, this technology has promise to allow patients to control existing prosthetic devices without continuous and mentally demanding training.

     

    The RPNI team is participating in the Coulter program for the third year. In the first two years of the project, they obtained compelling safety and efficacy data from 2 nonhuman primates who successfully used RPNI signals to control the fingers of a prosthetic hand.  During this year, the first in human experiment will be conducted.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/4889_a-living-biosynthetic-peripheral-nerve-interface or email Thomas Marten (tmarten@umich.edu) for more information.

  • In the US 20,000 patients suffer from short bowel syndrome. The decreased bowel length, results in insufficient nutrient absorption necessitating IV or parenteral nutrition (PN) as a mainstay of treatment. For many patients, PN is the only long term solution for this condition, and severely hampers both quality of life and life span. Patients experience intense hunger, have limited activity due to lengthy infusions, suffer potentially fatal infections and sepsis, liver failure, and blood clots. Interventions include surgical procedures to lengthen the bowel, bowel transplant, and administration of growth hormone. These therapies are costly invasive, and result in inconsistent bowel length/absorption increases.

     

    Pediatric surgeon Daniel Teitelbaum MD, mechanical engineering research scientist Jonathan Luntz Ph.D., and their colleagues have developed a non invasive and simple device placed in the bowel that uses mechanical stimulus to encourage tissue growth and lengthening of the bowel. Studies in animals with this device have been encouraging and show a lengthening of the bowel by greater than 50% over 2 weeks. If the same results can be achieved in humans, a substantial number of patients could be weaned off PN. As such, the MEND device may prove to be more effective than the surgical options and with far fewer complications. The device is likely to become a first intervention for a subset of patients and could be used with or without growth hormone treatment.

     

    During the year of participation in the Coulter program, the MEND team will build on their previous successful animal studies. They will generate prototypes incorporating critical refinements for safety, and validate the new design in animal models. Furthermore, safety innovations to the device such as the dilating fenestrated mesh attachment and the atraumatic tip could find utility in other gastrointestinal and catheter devices.

    Links to technology at UM Tech Transfer: Atraumatic tip, MEND 1, MEND 2 or email Thomas Marten (tmarten@umich.edu) for more information.

  • The ability to deliver medication directly into the eye via intravitreal injection therapy (IVT) has transformed the treatment landscape of a number of previously blinding diseases, including macular degeneration and diabetic retinopathy. The success of these therapies in preventing blindness has resulted in a dramatic increase in the number of intravitreal injections performed, with an estimated 4.1 million injections given in the United States alone in 2013. The injections are typically preceded by anesthesia predominantly administered via either a subconjunctival injection or cotton swabs soaked in anesthetic and held on the eye for several minutes. These anesthetic procedures are unnerving and uncomfortable for patients, pose constraints on the number of patients treated due to time to anesthetic onset, and increase the occurrence of ocular surface bleeding which can occur with any injection into the highly vascularized ocular tissue.

    In light of this need, Cagri Besirli MD, Ph.D., Kevin Pipe Ph.D., and Stephen Smith MD and their colleagues have designed a device to deliver ultra-rapid ocular anesthesia and vasoconstriction through the use of flash cooling of the surface of the eye at the injection site. The hand-held battery-operated device has the potential to provide anesthesia in less time and decrease patient discomfort. Shorter visits and increased turnover will ensure ready adoption by ophthalmologists and improve patient access to specialist care.

     

    The Coulter project will involve prototype refinement and first in human testing. Coulter is also assisting the team in navigating the regulatory frameworks and business formation steps required for the device's successful commercialization.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/6401_applicator-for-cryo-anesthesia-and-analgesia or email Thomas Marten (tmarten@umich.edu) for more information.

  • There are over 5 million intensive care unit admissions per year in the U.S. Approximately 4 million of these patients will experience some degree of immune dysfunction, the most severe of which is ‘cytokine release syndrome’ (CRS). Severe CRS results in rapid hemodynamic instability, and ultimately multisystem organ failure. There are specific therapeutics to down-regulate each of the cytokines, but due to the limited ability to rapidly measure serum cytokines, they are typically administered without knowledge of individual cytokine levels. This approach has lead to variable impact on clinical outcomes. Therefore, clinicians need near real-time serum cytokine values to institute and monitor personalized anti-cytokine therapies.

    The MicroKine team have developed a proprietary label-free and antibody-based microfluidic plasmon resonance sensor platform that enables, rapid (<30 min), sensitive quantification (dynamic range 10 – 10,000 pg/mL) of multiple (> 6 analytes) serum cytokines in small blood volumes (< 5 μL). Side-by-side comparison to the well-established enzyme-linked immunosorbent assay (ELISA), has shown the current MicroKine lab-grade prototype to be more sensitive, have a greater dynamic range by roughly two orders of magnitude, require smaller sample, and most importantly to provide results on the order of minutes rather than hours. By providing rapid information to physicians about individual immune response mediator levels (e.g. TNF-1 , IL-11 and IL-6, the targets of etanercept, anakinra and tocilizumab) MicroKine may help make existing treatments for CRS more targeted and effective, enhance clinical trial designs and allow for stratification of subjects.

    The MicroKine team consists of pediatric intensive care physician Timothy Cornell MD and engineering professor Katsuo Kurabayashi PhD and their colleagues. Over the course of this year participating in the Coulter program, they are developing a mass producible MicroKine device, validating it using clinical samples, and exploring the path to market. Once established for intensive care - an inexpensive disposable device such as the MicroKine chip could also find utility in less time-intensive applications such as monitoring cytokine levels in rheumatoid arthritis and inflammatory bowel disease.

    Click here or email Tom Marten for more information.

  • Approximately 5.8 million reconstructive procedures were performed by board certified plastic surgeons in 2014. Free tissue transfers from one part of a patient’s body to another provide a means for reconstructive surgeons to repair and replace body parts, restoring appearance and in many cases function and feeling. The most common reasons for patients to undergo tissue transfers is after tumor extirpation (i.e. breast cancer reconstruction), trauma, burn injury, or to restore absent function associated with congenital anomalies. In free tissue transfers, veins and arteries are surgically reattached in a procedure called microanastomosis. This procedure helps to restore blood circulation, and consequently, oxygen supply to the transferred tissue.

    There are two common methods of performing a microvascular anastomosis: (1) using a commercially available microvascular anastomotic coupler and (2) microsutures. Taking advantage of the flexibility of veins, the coupler provides a fast and secure microanastomosis. A key step in successfully using this coupling device is everting the vessel wall over a set of stainless steel pins. However, since arteries have a stiffer and more muscular wall than veins, it is much more difficult for the surgeon to evert the arterial wall over the pins of the coupler. This difficulty compromises the potential outcome with reduced anastomotic patency rates. As a result, arterial microanastomosis is currently performed by manual suturing. Because most vessels are 1-3mm in diameter, suturing is a laborious process that requires extensive training and takes approximately 23.5 minutes per vessel.

    Plastic surgeons Drs. Paul Cederna and Adeyiza Momoh, in collaboration with Mechanical Engineers Dr. Albert Shih and Jeffrey Plott, have developed a microsurgical tool that everts arterial walls over the coupler pins when used in conjunction with the microvascular anastomotic coupler. This device reduces arterial microanastomosis procedure time to 5 minutes, while minimizing required operator skill, concentration, and fatigue during long, complex operative procedures.

    The Coulter project will involve prototype refinement and in vivo pre-clinical studies of the device to validate coupling efficiency and anastomosis time.

    Click here or email Tom Marten for more information.


2014 - 2015 Funded Projects:

  • Second year of funding – 2014 funding: $102,798; funding to date: $222,588

    Every day in the US, 507 people lose a limb; while, 1000 children per year are born with limb defects. The use of prosthetic devices may determine whether persons with amputations return to work. Advanced prosthetic limbs now provide motorized joints with fine controls and sensorization similar to normal limbs (e.g. iLimb). However, the reliability of methods to control these limbs suffers from lack of suitable transduction of natural signals. Residual peripheral nerves continue to naturally conduct native control and sensation signals through their pathways that are anatomically understood. Current methods for controlling prostheses include capturing muscle signals with skin surface electrodes or capturing nerve signals with nerve cuff electrodes or nerve implanted wire electrodes. These three methods have problems because signals lack clarity, reliability, and amplitude. These interfacing methods are not intuitively based on the anatomical nerve functions.  Thus users are trained over 6 to 9 months to continually anticipate how activation of one body area will make the prosthetic device move.

     

    Cindy Chestek, Ph.D., collaborating with Paul Cederna, MD, and Melanie Urbanchek, Ph.D., with their colleagues developed the Regenerative Peripheral Nerve Interface (RPNI) as a method of recording signals that are two orders of magnitude larger than signals recorded from nerve fascicles. This is done by grafting small pieces of autologous muscle tissue to the ends of residual nerves. The muscle becomes reinnervated and then acts as an amplifier for the nerve signals. The amplified signals are then detected by a small implantable device then precisely records the signals sent through only the connected nerve fascicle. Receivers that translate the recorded signals and interface with a prosthetic device are housed within the prosthetic socket.  Thus, this technology has promise to allow patients to control existing prosthetic devices without continuous and mentally demanding training.

    The RPNI team is participating in the Coulter program for the third year. In the first two years of the project, they obtained compelling safety and efficacy data from 2 nonhuman primates who successfully used RPNI signals to control the fingers of a prosthetic hand.  During this year, the first in human experiment will be conducted.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/4889_a-living-biosynthetic-peripheral-nerve-interface or email Thomas Marten (tmarten@umich.edu) for more information.

  • $121,974

    There are 1.7 million people living with limb loss in the U.S., increasing by 185,000 each year. All of these amputees will develop neuromas, or large, tangled bundles of nerve and scar tissue, due to the untreated nerve division and/or trauma at the amputation site. Of patients with neuromas, close to 25% will suffer from debilitating neuroma pain. It is well documented that neuroma pain leads to prosthesis abandonment due to compression of neuromas by the prosthetic socket. Currently accepted treatments focus on relieving symptoms without addressing the biology of a regenerating peripheral nerve, resulting in some alleviation for only 3-12 months. Repeated treatments, loss of productivity, and side effects of medications create increasing healthcare expenditures and reduce quality of life.

    Plastic Surgery Faculty Paul Cederna, MD and Melanie Urbanchek, PhD, and Biomedical Engineering Faculty Cynthia Chestek, PhD, have developed a novel technology for recording neural signals as an interfacing modality between amputees and prosthetic limbs. Their strategy is to provide a new home for regenerative nerves by grafting a piece of denervated muscle to the end of the nerve. As the muscle degenerates and regenerates, it releases trophic factors that encourage neural regeneration. These regenerating muscle fibers serve as new home targets for the injured nerves and therefore prevent neuromas from forming. The team has validated this concept in 500+ rodents for up to 20 months. However, the current strategy of constructing these interfaces individually, by hand, requires substantial technical skill and procedure time, which will likely hinder clinician adoption of the technology.

    Drs. Cederna, Urbanchek, and Chestek teamed up with Plastic Surgery Faculty Dr. Nicholas Langhals, colleagues Grant Kruger, PhD and Albert Shih, PhD, and students Jeffrey Plott and Jordan Kreda, in this Coulter project to develop a prototype surgical tool that creates appropriate, uniform sizes of muscle and affixes them to the end of the nerve. Prototype development was informed by clinical feedback on the form and function of the tool, with the goal of reducing procedure time by approximately 60-70%. The surgical tool design parameters and efficacy were validated using an acute pig model. Following completion of this work, this technology was well-positioned for license to an existing entity.

  • $149,059

    CTCs are cells that have detached from a primary tumor and enter the bloodstream with the potential to establish secondary metastatic tumors all over the body. CTCs are prognostic indicators and carry with them information about genetic mutations of the primary tumor and its sensitivity to drugs. As such, CTCs also have the potential to serve as biomarkers of disease recurrence, early detection, response/resistance to therapy, and genomic analysis (“liquid biopsy”) for personalized medicine. However, the concentration of CTCs can be as low as one per billion red blood cells which is difficult to detect and in some cases require many painstaking steps.

    Dr. Sunitha Nagrath and her colleagues have developed a cell capture and imaging chip for the sensitive antibody-based isolation of cells directly from whole blood. In principle, any rare cell with corresponding antibodies can be captured from heterogeneous solutions using this chip. It allows on-chip staining and imaging, or extraction of genetic material for further analysis. Current innovations are also enabling release of live cells after capture. By providing a highly sensitive capture technique on a disposable device, the chip enables monitoring of CTC (or other rare cell) counts and further analysis of those cells from patients. The chip has been validated with the use of clinical samples from prostate-, breast- and lung cancer patients.

    During the course of Coulter funding, the team explored ways to make the chip manufacturable and automated, and explored where in the market the chip could best meet an unmet need.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/5137_graphene-oxide-based-circulating-tumor-cell-capture-device or contact Thomas Marten (tmarten@umich.edu) for more information.

  • $102,710

  • Second year of funding – 2014 funding: $140,327; funding to date $210,825


2013 - 2014 Current Funded Projects:


2012 - 2013 Funded Projects:


2011 - 2012 Funded Projects:


2010 - 2011 Funded Projects:


2009 - 2010 Funded Projects:


2008 - 2009 Funded Projects:


2007 - 2008 Funded Projects:


2006 - 2007 Funded Projects: