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IRVINE, CA, United States

Cuccia D.J.,Modulated Imaging, Inc.
Proceedings of SPIE - The International Society for Optical Engineering | Year: 2012

We present an overview of Spatial Frequency Domain Imaging (SFDI), a non-contact near infrared (NIR) imaging approach that enables rapid, quantitative determination of the optical properties and in vivo concentrations of chromophores over a wide field-of-view. SFDI is capable of rapidly rendering quantitative two-dimensional maps of oxy and deoxy hemoglobin, total hemoglobin (related to blood volume), tissue oxygen saturation, water content, and scattering coefficient (related to tissue structure). © 2012 SPIE.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 1.31M | Year: 2011

DESCRIPTION (provided by applicant): The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries and veins to the blood vessels at the recipient site. These procedures enable reconstructive surgery after trauma, as well as after surgical resection of cancer. Flap transfer surgery is subject to failure via a number of modes including vascular insufficiency caused by mechanical obstruction of the artery or vein, injury caused to the transferred tissues due to the lack of blood flow during the flap transfer, or due to ischemia-reperfusion injury. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap viability. Several studies have demonstrated that frequent monitoring and early detection of compromise results in earlier intervention which reduces the number of devastating complications that lead to tissue loss. Early in the era of microsurgery, flap monitoring was performed with only clinical observation of skin color, capillary refill, and dermal bleeding. However, issues related to staffing and subjective variations in clinical assessment of a flap's perfusion have led to the search for objective methods of flap monitoring. One promising technology for measuring local tissue oxygenation in-vivo is diffuse optical spectroscopy (DOS). DOS is a quantitative near-infrared (NIR) spectroscopy technique that can determine absolute concentrations of chromophores such as oxy and deoxy hemoglobin, fat and water. Modulated Imaging (MI) is a NIR imaging method invented at BLI that is based on the principles of DOS and employs patterned illumination to interrogate biological tissues. This non-contact approach enables rapid quantitative determination of the optical properties and in-vivo concentrations of chromophores over a wide field-of-view. The central aim of the proposed research is to further the development of Modulated Imaging and to assess the viability of this as a means to determine status of tissue reconstruction flaps. In Phase I, we carried out an in-vivo MI study using a dorsal pedicle flap rodent model. The dorsal pedicle flap is easily implemented to establish controlled ischemia and re-perfusion of the wounds. This allowed us to employ MI to deduce spatially resolved maps of tissue hemoglobin, oxygenation and hydration over the course of several days. In Phase II we propose to develop and validate an MI instrument for clinical use. Investigations will first evaluate the performance of MI in a controlled model of partial vascular congestion using adult Yorkshire pigs. This will be followed by a study in which MI and a potentially competing FDA cleared device will be employed in a clinical situation in order to assess local flap status. In parallelwith the Phase II research outlined herein, we will aggressively pursue commercialization of a medical device based on MI. PUBLIC HEALTH RELEVANCE: The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries and veins to the blood vessels at the recipient site. The medical utility of this process is to allow for reconstructive surgery after trauma, as well as after surgical resection of cancer. This type of reconstructive surgery is subject to failure caused by to mechanical obstruction of the artery or vein; injury caused to the transferred tissues due to the lack of blood flow when a free tissue flap is performed, (the tissue is disconnected prior to re-attaching the blood vessels); or due to a type of injury call ischemia- reperfusion injury, which is a type of injury that results after blood flow has been returned to the transferred tissue. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap to survive. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. In this proposal we will develop and validate an instrument that has the potential to identify flap failure earlier than is currently achievable. A successful effort has the potential to enable development of a new medical device thatwill have the capability to guide reconstructive surgery and post-surgical recovery, both reducing post-surgery complication rate and reducing uncertainty in flap healing. This may shorten the duration of hospital stay and associated heath care costs in addition to improving surgical outcomes.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1.00M | Year: 2012

Accurate assessment of burn size, depth and the compromise of normal tissue physiology, as well as the tracking of wound response, is essential for successful treatment of burns and one of the major problems that face clinicians and surgeons. The primary method of burn wound assessment is subjective clinical evaluation which is neither accurate nor consistent between care givers. For this proposed effort, Modulated Imaging Inc. will evaluate our clinically deployable advanced camera system to perform burn depth analysis. This non-contact, wide field-of-view approach will ultimately provide quantitative determination of the optical absorption and scattering properties of burned skin as a function of depth and provide quantitative, color-coded maps of tissue physiology including tissue blood volume, oxy-/deoxyhemoglobin, water concentration, and tissue matrix. These data products should provide the clinician with a real-time, accurate assessment of burn depth and tissue viability. Under this proposed Phase II effort, MI will develop and validate indices of burn severity via preclinical testing and a clinical pilot study.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 148.98K | Year: 2011

Accurate assessment of burn size, depth and the compromise of normal tissue physiology, as well as the tracking of wound response, is essential for successful treatment of burns and one of the major problems that face clinicians and surgeons. The primary method of burn wound assessment is subjective clinical evaluation which is neither accurate nor consistent between care givers. For this proposed effort, Modulated Imaging Inc. will evaluate our clinically deployable advanced camera system to perform burn depth analysis. This non-contact, wide field-of-view approach will ultimately provide quantitative determination of the optical absorption and scattering properties of burned skin as a function of depth and provide quantitative, color-coded maps of tissue physiology including tissue blood volume, oxy-/deoxyhemoglobin and water concentration. These data products should provide the clinician with a real-time, accurate assessment of burn depth and tissue viability. Under this proposed Phase I effort, MI will document the requirements of a burn analysis system for practical use, perform theoretical modeling of the optical properties of layered tissues, conduct imaging analysis on tissue-simulating optical phantoms, and perform testing on burned ex-vivo porcine skin.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 700.00K | Year: 2009

DESCRIPTION (provided by applicant): Quantitative characterization of tissue structure and function is one of the most challenging problems in Medical Imaging. Field of view, depth of interrogation, and resolution are critical features that dramatically impact image quality and information content. To this end, we propose to advance the development of a new imaging technique known as Modulated Imaging (MI) and to assess the viability of this as a clinical device that will provide objective parameters that can be used to determine status of in-vivo tissue. Modulated Imaging employs patterned illumination to non-invasively obtain subsurface images of biological tissues. This non-contact approach enables rapid quantitative determination of the optical properties of tissues over a wide field-of-view. When combined with multi-spectral imaging, the optical properties at several wavelengths can be used to quantitatively determine the in-vivo concentrations of chromophores that are relevant to flap health, namely, oxy- and deoxy-hemoglobin. Furthermore, images at various spatial frequencies can be processed to visualize subsurface features in terms of scattering and absorption. Once optimized for a particular application, MI can be executed using consumer grade electronics such as those currently employed in digital cameras and DLP projectors. Hence, it is plausible to consider the potential for Modulated Imaging to be executed as a relatively inexpensive medical device. The broad goal of this proposal is to develop a robust, user-friendly MI platform capable of quantitative imaging appropriate for deployment at clinical sites. It will possess sufficient spatio-temporal resolution to study both fast (i.e., ms timescale) and localized (i.e., hundreds of m to mm) events at depths of several millimeters in tissues. This will enable quantitative insight into disease progression and therapeutic response in areas such as wound healing, dermatology, skin cancer and reconstructive surgery. To achieve this, we propose to design and fabricate a platform instrument based on Modulated Imaging (MI), a technology that has been developed over the course of the most recent Laser and Medical Microbeam Program (LAMMP; a NIH/NCRR Biomedical Technology Resource Center) funding period. The proposed research will following a methodical development plan including the following steps: 1) Design and fabrication of a standardized Modulated Imaging platform for human subject measurements, 2) Design and development of a turnkey software interface for clinical use, 3) Validation of the MI device performance in a laboratory setting and 4) Deployment of the MI device clinically for real-world testing and evaluation. Leveraging existing IRB approved clinical protocols and ongoing LAMMP- related studies, we will perform feasibility studies for skin-related applications, including normal skin, port-wine stain, melanoma, and skin flap surgeries. Upon successful completion of the Phase I research outlined herein, we intend to pursue a Phase II proposal that will involve fabrication and deployment of multiple devices. Ultimately, our intent is to methodically develop Modulated Imaging as a commercially viable medical device. PUBLIC HEALTH RELEVANCE: We propose to develop a robust imaging platform for quantitative imaging of subsurface tissue properties for clinical imaging applications. This system will implement Modulated Imaging (MI) technology, a non-contact imaging method developed under the Laser Microbeam and Medical Program center at the Beckman Laser Institute, UC Irvine. By accurately knowing what areas of tissue are healthy during surgery or in the Intensive Care Units (ICU), doctors may intervene and perform more timely procedures to avoid permanent tissue damage. Benefits include margin identification of skin cancer lesions, reducing unnecessary wound care procedures such as amputations in diabetic and trauma patients, and skin grafting in burn patients. Economically, the Modulated Imaging device will reduce hospital costs by eliminating unnecessary additional hospital days for these patients.

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