Medical Devices

The following Medical Devices are currently available for licensing from OTAM:

• Biomechanically Validated Pressure Ulcer Simulator
• Wireless Systems for Detection, Processing, and Activation of Neural Events Using Onboard Computer Control
• Computer Aided Spinal Rod Bender
• Novel Minimally Invasive Measurement of Interstitial Compartment Pressure
• Vacuum-Assisted Continuous Joint Movement Device
• Implantable Cannula Connector System

Biomechanically Validated Pressure Ulcer Simulator 

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INVENTORS: Dr. Teresa Conner-Kerr, Dr. Phil Sanger, Dr. Jessica Sparks

It is estimated that pressure ulcers place a $1.2 billion annual burden on the U.S. healthcare system, partially because of the complexity of identifying, treating, and managing these wounds. A patient simulator that provides real-time information will reduce the occurrence of preventable medical error costs through hands-on training that will produce more confident and skilled healthcare workers.   

Researchers at WCU, Wake Forest, and WSSU have developed a human patient simulator specifically for education in pressure ulcer management and prevention. This simulator will mimic the bioinformatics of a geriatric patient and deliver real-time information that will educate practitioners of the different biomechanical triggers that cause ulcer formation while teaching users to distinguish surface pressure from localized deep tissue stress.  The working prototype is also supplemented by a computer interface and training manual, making it easily adoptable into any situation. In addition to its educational features, the pressure ulcer simulator is capable of assessing the efficacy of preventative and therapeutic devices.

Commercial Applications

• Simulator will reflect biomechanical stress and strain conditions within soft tissue for a variety of body positions 
• Provides real-time feedback on tissue pressure conditions in multiple tissue layers at high-risk anatomical sites
• Educates practitioners to distinguish surface pressure from localized deep tissue stress
• Simulation-based training will promote clinical skills and communication between healthcare staff and patients
• Therapeutic device assessment capabilities will empower clinical facilities by eliminating secondary costs arising from hospital-derived pressure ulcers which are considered a “non-event” for Medicare billing purposes

Licensing Contact Information

Stephen J. Susalka, Ph.D.
Assistant Director
Email: ssusalka@wakehealth.edu
Phone: (336) 716-3729

Wireless Systems for Detection, Processing, and Activation of Neural Events Using Onboard Computer Control

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INVENTORS: Drs. Sam A.  Deadwyler and Robert E. Hampson

Overview

Knowledge of brain function and the neurodevice market ($5.5 billion) are both growing rapidly, as is the need for better and more convenient methods of observing and interacting with the brain.  Unfortunately, the systems currently employed to record and stimulate neural activity directly via  implanted electrodes remain inconvenient and impede collection of meaningful biological data.  

Invention

Researchers at the Wake Forest School of Medicine have developed a compact system that analyzes, compresses, and then transmits cognitively relevant neural action potential data wirelessly from subject to computer via the most current Bluetooth technology.  The system can transmit action potential waveform  and time-stamp data from identified neurons in awake, behaving subjects while engaged in cognitive tasks.  In addition, it can be employed to wirelessly program stimulation of the same neural tissue via the electrodes that record signals.  The system can be used for basic research, for small mammals such as mice, or as part of a system to monitor, diagnose and even  treat brain disorders in humans. 

Unique Properties

• Scientifically validated prototype:  Tested in laboratory settings (J. Neurosci. Methods)
• Record individual neuron firing data, for longer times and distances (30 meters).
• Configurable self-contained stimulation and recording methodology
• Study the neural basis of natural behaviors not possible via other wireless systems.
• Develop better, more convenient brain-machine interfaces for neuromodulation (a $1.38 billion market) and neuroprosthetics (a $540 million market).
• Simplify surgical procedures for  neural recordings  (Neurosurgical Market: $2.5 Billion)

Additional Information 

•  Issued U.S. Patent 7,460,904    
•  “A wireless recording system that utilizes Bluetooth technology to transmit neural activity in freely moving animals” J Neurosci Methods. 2009 Sep 15;182(2):195-204  

Licensing Contact

Stephen J. Susalka, Ph.D.
Assistant Director
Email: ssusalka@wakehealth.edu
Phone: (336) 716-3729

Computer Aided Spinal Rod Bender

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Scoliosis is a commonly diagnosed pediatric pathology. The current clinical paradigm for designing and shaping the surgical corrective instrumentation is poorly resolved and highly personnel intensive. Corrective surgery typically involves the fixation of segments of the vertebral column through the attachment of curved titanium rods to the spine through an arrangement of hooks and pedicle screws. The shaping of these rods is done during surgery with the patient's spine exposed in a trial and error procedure by using hand tools for bending and cutting the rods. As this part of surgery may take up to several hours, this process is both tiring to the surgeon and involves increased risks to the patient. Significant treatment benefits and cost savings will be realized with a computer-aided system for on-the-fly design and automated manufacture of corrective instrumentation for scoliosis surgery. This invention describes a combination of manufacturing hardware and a computer-aided-design system to impose the desired curvature on an actual rod for immediate surgical use. The proposed system will significantly impact the time and physical effort required of the surgeon during surgery in designing and shaping the spinal implant. The reduced time required for the surgical procedure reduces the exposure of the patient to infection. The increased accuracy of the produced output as compared to the manually shaped implants is expected to improve the likelihood of a desirable outcome of a spinal fixation surgery.

Commercial Applications

Patients undergoing surgical spinal implementation for scoliosis deformity

Status

Patent Pending

Licensing Contact

Camilla P. Hansen, Ph.D.
Licensing Analyst
Email: chansen@wakehealth.edu
Phone: (336) 716-3729

Novel Minimally Invasive Measurement of Interstitial Compartment Pressure

Video: Nano-torr, Minimally Invasive Diagnostic Pressure Measurement
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INVENTORS: Dr. David Carroll and colleagues

Overview

Acute Compartment Syndrome (ACS) can lead to devastating disabilities, amputation, or even death, if not diagnosed and treated immediately. ACS occurs when increased interstitial pressure within a closed muscle compartment, often the result of a fracture or other trauma, compromises blood flow to muscles and nerves within that compartment and results in ischemia and significant tissue and nerve damage. Rapid diagnosis is critical as it has been demonstrated that within eight hours of ischemia of the compartment, the damage to the muscles is often irreversible. Current methods of diagnosing ACS are extremely invasive and rely on the insertion of a large bore needle (16- 18- gauge needle) into the compartment to measure interstitial pressure. Clearly, the need exists for a more sensitive, minimally invasive pressure sensor to diagnose ACS.

Invention

Researchers at Wake Forest University and Wake Forest School of Medicine have developed a novel pressure sensor that can measure real time interstitial compartment pressure while avoiding the inherent invasiveness of catheter techniques. This sensor has been shown to easily measure pressures as low as 10mm Hg, and studies are ongoing to demonstrate a detection of pressure as low as 2mm Hg. This minimally invasive novel technology has the potential to replace the current fluid-filled manometric systems or solid-state transducers that are currently used to measure interstitial compartment pressure.

Licensing Contact

Stephen J. Susalka, Ph.D.
Assistant Director
Email: ssusalka@wakehealth.edu
Phone: (336) 716-3729

Vacuum-Assisted Continuous Joint Movement Device

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Implantable Cannula Connector Systems

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INVENTOR: David Klorig, Department of Neurobiology and Anatomy 

Researchers at Wake Forest School of Medicine have developed a novel connector for optogenetics applications to connect implantable optical fibers. A unique design allows the connectors to be quickly connected and disconnected while maintaining a secure connection during use. The connectors also allow for freedom of rotation and are ideal for chronic implantation. Optional features provide a barrier to fluid flow and infection while allowing the passage of light into the brain. In addition to optical applications, the connectors have a number of  advantages over the screw-type connectors used in drug-delivery cannula systems.

Optogenetics is an emerging field combining optical and genetic techniques to probe neural circuits within intact animals, at the high speed (millisecond-timescale) needed to understand brain information processing. Existing screw type connectors can be difficult to connect and do not allow for freedom of rotation. The open cannulas currently in use also allow fluid to flow out of the brain and are prone to bacterial contamination. Our novel connector solves these problems and is so easy to use that it often alleviates the need to anesthetize the animal, enabling high-throughput behavioral, physiological, and/or pharmacological testing.

Important Features

•   Small size and weight 
•   Quick and easy to connect 
•   Allows precise placement of optical fibers 
•   Can be used to secure a fluid delivery system 
•   Have been extensively tested in awake behaving rats 

Licensing Contact

Stephen J. Susalka, Ph.D.
Assistant Director
Email: ssusalka@wakehealth.edu
Phone: (336) 716-3729