Currently Funded Projects

5/22/15 Orthotics and Prosthetics Center.

 

The following projects funded in the current project cycle which runs from July 1st, 2016 to June 30th, 2017.
  • CryoAnesthesia for Intravitreal Injections
    Cagri Besirli, MD, PhD, and Kevin Pipe, PhD

    Product Description: A handheld device that employs precision cooling to achieve rapid ocular anesthesia prior to intravitreal injections.

    Project Overview: 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 has resulted in a dramatic increase in the number of injections performed, with an estimated 8 million injections given in the US in 2014. Prior to injection, anesthesia is administered by either a subconjunctival injection or topical application of a lidocaine-based anesthetic. These methods result in patient discomfort, a higher occurrence of ocular surface bleeding, and delays of 7-10 minutes for complete anesthesia to set in.

    In light of this need, Cagri Besirli MD, PhD, Kevin Pipe, PhD, Stephen Smith, MD, and GunHo Kim, PhD, developed the cryoanesthesia device. This device provides ocular surface anesthesia in 30 seconds or less, significantly improving the patient treatment experience. In addition, this device makes it possible for retina specialists to significantly increase the number of patients they can treat in a day, improving patients’ access to sight-preserving care.

    This project first received Coulter funding last year for the FY16 cycle. During their first year of Coulter funding, the team developed their first prototype and conducted device safety testing. The team received IRB approval for a first-in-human (FIH) study, which they initiated at the Kellogg Eye Center. This ongoing study is designed to evaluate different temperatures and times for focal ocular surface cooling. With this second year of Coulter funding, the team will use FIH study data and professional market research feedback to further refine the prototype. In addition, they are partnering with a regulatory consultant to prepare for a Pre-Submission meeting with the FDA. One of the goals of the FDA meeting is to obtain guidance for a pivotal second clinical study designed to test the efficacy of cryoanesthesia versus current methods of ocular anesthesia. The clinical efficacy study will be conducted at the Kellogg Eye Center using the newly refined prototype design.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/6401_applicator-for-cryo-anesthesia-and-analgesia

    Email Thomas Marten (tmarten@umich.edu) for more information.

  • "Slit-Stent" Lacrimal Drainage Device for the Treatment of Epiphora Due to Insufficient Drainage

    Alon Kahana, MD, PhD, Albert Shih, PhD, and Jeffrey Plott, MSE & PhD Candidate

    Product Description: An ophthalmic lacrimal stent constructed to facilitate drainage of tears through the stent after placement, which will provide immediate symptomatic relief of epiphora (excessive tearing).

    Project Overview: Epiphora, or excessive tearing, is a common symptom of many ophthalmic conditions in which the tear drainage system through the nose (i.e. nasolacrimal system) is occluded. Most of these conditions are not life threatening, but epihpora can cause blurred vision, inflammation, skin irritation, dacryocystitis (lacrimal sac infection), and even orbital cellulitis if a bacterial infection progresses deeper into the eye socket. Oculoplastic surgeons treat epiphora by dilating the lacrimal duct or surgically creating a new tear drainage system, and placing a lacrimal stent to allow healing. Currently available stents take up space in the newly created tear drainage system, which prevents full tear drainage until the stent is removed 3-6 months later.

    Oculoplastic Surgeon Alon Kahana, MD, PhD, teamed up with Mechanical Engineers Albert Shih, PhD and Jeffrey Plott, a PhD candidate, to develop the “Slit-Stent”, a lacrimal stent constructed to facilitate drainage of tears through the lumen of the stent after placement. The goal is to provide patients immediate symptomatic relief. With Coulter funding, the team will pursue an FDA Investigational Device Exemption (IDE) and conduct a clinical study to demonstrate that “Slit-Stent” provides improved symptomatic relief from epiphora while maintaining mechanical integrity and having no significant difference in infection risk compared to standard stents.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/6724_lacrimal-stent-with-opening

    Email Thomas Marten (tmarten@umich.edu) for more information.

  • "Dynamic Arterial Morphology Analysis for Prediction of Intradialytic Hypotension"
    Kevin Ward, MD, Kenn Oldham, PhD, Kayvan Najarian, PhD, Michael Heung, MD, Sardar, Ansari PhD

    Product Description: A small, wearable, noninvasive monitor that predicts the onset of intradialytic hypotension during hemodialysis and provides a warning to dialysis clinic staff, allowing them to implement countermeasures to prevent the hypotensive episode.

    Project Overview: Nearly 400,000 patients in the US suffer from end-stage renal disease or chronic kidney disease. These patients account for the 43.5 million hemodialysis sessions per year. Intradialytic hypotension (IDH), a significant drop in blood pressure, occurs in 20-30% of all hemodialysis sessions. This sometimes leads to session abandonment and fluid volume overload as patients are not able to be adequately dialyzed. It is the most severe complication of dialysis and leads to significant morbidity and mortality.

    Patients undergoing hemodialysis are currently monitored by intermittent blood pressure measurements, patient-reported symptoms, hematocrit levels, and oxygen saturation levels. Patients who have had IDH in previous hemodialysis sessions may be pre-emptively treated with vasopressors to prevent IDH onset. These standard-of-care practices can only detect IDH once it has begun or try to prevent IDH from occurring, but they cannot predict IDH occurrence and allow nephrologists or dialysis nurses to implement preventative measures, such as decreasing the ultrafiltration rate, in time to prevent hypotension.

    Emergency Medicine Physician Kevin Ward, MD, Mechanical Engineer Kenn Oldham, PhD, and Computational Medicine and Bioinformatics colleagues Associate Professor Kayvan Najarian, PhD, Nephrologist Michael Heung, MD, and Postdoctoral Research Fellow Sardar Ansari, PhD, have developed a small, wearable, noninvasive monitor that predicts the onset of IDH during hemodialysis and provides a warning to dialysis clinic staff, allowing them to implement countermeasures to prevent the hypotensive episode and continue the dialysis session. With Coulter funding, the team will build prototype devices to obtain clinical data on patients undergoing dialysis in the U-M Acute Dialysis Unit to refine and optimize the prediction algorithm. The goal of the study is to demonstrate the ability to predict IDH within a minimum of 2 minutes of onset with 80% sensitivity and specificity.

    Email Thomas Marten (tmarten@umich.edu) for more information.

  • Miniaturized Hemoretractometer (mHRM) Blood Coagulation Diagnostic
    Kevin Ward, MD, and Jianping Fu, PhD

    Product Description: A small, inexpensive, easy-to-use and maintain, near point-of-care whole blood thromboelastography device (mHRM) that provides equivalent results to commercially available thromboelastography devices in less time.

    Project Overview: Every year in the US, there are 14.6 million blood transfusions and 350,000 major cardiovascular surgeries that require the acute use of blood products (pro-coagulation) or anticoagulants to maintain hemostasis and prevent the development of coagulopathy in patients.

    Blood coagulation is a critical hemostatic process that must be properly regulated to maintain the delicate balance between bleeding and clotting. The most widely used coagulation monitoring tests, prothrombin time (PT) and activated partial thromboplastin time (aPTT), only provide information on clotting time associated with the plasma protein compartment of the coagulation system and not on other critical measures including platelet function, clot strength, and fibrinolysis. Coagulation diagnostics using whole blood thromboelastography are rapidly gaining clinical acceptance and provide information on all critical measures. However, commercially available systems are significantly limited by their size, cost, inter-assay variability, and significant user intervention. This renders them suboptimal for point-of-care (POC) or near-POC applications.

    Emergency Medicine Physician Kevin Ward, MD and Mechanical Engineer Jianping Fu, PhD, have developed a small, inexpensive, easy-to-use and maintain, near point-of-care whole blood thromboelastography device (mHRM) that provides equivalent results to commercially available thromboelastography devices in less time. With Coulter funding, the team will improve the mHRM manufacturing method, conduct clinical testing to verify mHRM reliability, and demonstrate equivalency of the mHRM to commercially available thromboelastography devices.  The technology will allow wider scaling of important coagulation measures that may reduce blood product use and improve survival in patients requiring coagulation management.

    Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/6536_a-microscale-whole-blood-coagulation-assay-platform

    Email Thomas Marten (tmarten@umich.edu) for more information.