This Small Business Innovation Research (SBIR) Phase II project has as its main objective the development of a mobile physiological optical imaging hardware and software system to empower clinicians with the ability to deploy, capture, assess and distribute standards compliant image data characterizing deep wounds and cardiovascular conditions. The mobile system will allow clinicians to rapidly identify the presence of hidden wound conditions or problematic blood flow patterns thus allowing care facilities to provide more cost effective and informed care to their patients, while minimizing financial losses associated with wound related hospital acquired conditions. The intellectual merit of this project lies in its scientific pursuit to define, develop, and distribute a comprehensive systems platform that will significantly accelerate the deployment of suitable physiological optical imaging solutions into the market. The research includes linking illumination patterns to physiological conditions while implementing mapping transfer functions by way of digital signal processing. The research objectives include system definition, integration, algorithmic optimization, and clinical validations.
The broader impact/commercial potential of this project is to provide substantially affordable noninvasive imaging tools that may be used to assist in treatments that are more accessible to persons in remote areas or those having economic disadvantages. The portable device increases the ability of qualified clinicians to access patient wound care imaging diagnostics remotely, improving quality of care and accessibility to society. Broader commercial benefits include reductions in hospital visits and stays due to more thorough wound assessments and greater accessibility. The mobile system will enable care decisions that are more closely coupled with the state of the underlying tissue and related hemodynamics. It will also allow clinicians and patients to more effectively monitor the benefits of care decisions. The development of the novel and cost-effective optical system to facilitate the imaging of clinically and physiologically meaningful information will fill a void in the medical imaging industry for a point of care solution capable of providing quantitative visualization of physiological processes critical to wound care. The development of the mobile imaging technology will enhance scientific and technological understanding in the areas of optical-tissue image mapping, optoelectronic illumination systems, image processing, clinical applicability and real-time imaging scenarios.
Annually, millions of American suffer from and are treated for skin wounds. One particular area, chronic wounds, consisting of pressure ulcers, diabetic ulcers and venous insufficiency are of growing concern. The prevalence of pressure ulcers in acute care hospitals is between 10 and 40 percent and their associated costs approach $11 billion.[1] Since these wounds are preventable, there is a strong compassionate and financial incentive for hospitals in finding ways to improve the staging of pressure ulcer severity. Yet surprisingly, the US is lacking effective diagnostics for chronic wounds causing wound care therapies to be poorly targeted to specific patients. Spectral MD, with the generous support of the NSF SBIR program, is charged with filling this gap in medical care. Sufficient blood flow to a wound is the most critical factor in tracking progression or regression. Non-invasive and portable devices to measure blood flowing just below the skin's surface could aid in tracking wounds and bridge the gap in the current standard of care. These devices would assist doctors in predicting the severity of an ulcer, possibly even before they are noticeable on the skin surface. Optical, non-contact and 2-D measurement of the arterial blood's pulse waveform in the skin has been achieved, but never commercialized for the health care system to utilize prior to Spectral MD. Spectral MD developed its DeepView imaging system based on a technology platform developed in collaboration with the University of Texas Southwestern Medical Centre at Dallas (Dallas, Texas). The technology enables blood flow visualization through illumination of the skin tissue with non-coherent using infra-red (IR) light. [2] Without the device ever touching the patient, light is introduced to the tissue where the photons pass through the skin, and interact with the blood. This interaction is known to result in a small portion of reflected light with its intensity modulated by the pulsing arterial circulation (Fig. 1). Spectral MD’s imaging system processes this reflected light and produces images on an external monitor (Fig. 2). Relative differences in the reflected light from one area to the next indicate physiologic processes such as inflammation, tissue breakdown, or healthy granular bed. Unlike other diagnostic devices, DeepView does not require transporting the patient to an imaging center, injecting dyes, or using harmful radiation such as X-rays. Commercialization of this technology would require expertise in optical systems for delivering and collecting light from the tissue as well as signal processing expertise to generate clinically useful images from the reflected light. Solving these issues was the focus of the Phase I and Phase II NSF SBIR Grant awarded to Spectral MD. During the execution of the NSF SBIR Phase I award Spectral MD developed the prototype DeepView pulse-wave imaging device and demonstrated that variations in skin tissue blood-flow could be detected to produce images without contacting the skin's surface. The following Phase II award helped fund our clinical feasibility study where we collected approximately 1,500 unique patient images of chronic wounds and burns with the prototype DeepView device. Drawing from this large database our engineers developed signal processing algorithms to improve image accuracy and clinical usability (Fig. 3). The NSF’s funding helped us create new relationships with academic institutions and centers to bolster our internal image processing analysis. These institutions included: the Gordon-CenSSIS center, Northeastern University, The University of Texas El Paso, and The University of Puerto Rico Mayaguez. We disseminated our findings in publications and at research conferences where we could target our medical users (Fig. 4). This work culminated in the commercialization of the generation one device following an FDA regulatory submission to successfully clear the DeepView device for sale in the US.[3] The commercial device is suitable for blood flow studies in a variety of applications including wound healing, plastic surgery, and dermatology to name a few. Spectral MD has since transitioned from the NSF SBIR to a contract from an entity within the Dept. of Health and Human Services to develop a product based on the same technology to aid burn patients.[4] This contract will fund the development of the imaging technology for both burn and chronic wound applications and will relieve a major bottleneck in burn care. The NSF SBIR grant provided critical funding for Spectral MD to complete its concept research and transition to a product development company. References: Young DL, Shen JJ, Estocado N, Landers MR. Financial impact of improved pressure ulcer staging in the acute hospital with use of a new tool, the NE1 Wound Assessment Tool. Adv Skin Wound Care. 2012 Apr;25(4):158-66. Technical Insights: Inside R&D: Innovative Point of Care Deep-Tissue Imaging Device. Frost and Sullivan Profile. Published Oct. 2013. DeepView Medical Imaging Device FDA 510(k) Clearance Letter [K124049]. BARDA funds development of device to aid burn patients in disasters. September 19, 2013. www.phe.gov/Preparedness/mcm/Pages/deepview-20130919.aspx
