IRVINE, CA, United States
IRVINE, CA, United States
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Method and apparatus for obtaining qualitative and quantitative analysis of the optical properties or structures of tissue or turbid medium at one or more wavelengths via 1) detection at a single spatial location on the surface of a turbid medium (such as tissue) under two or more structured light conditions or 2) detection at two or more spatial locations on the surface under a single structured light condition.


Method and apparatus for obtaining qualitative and quantitative analysis of the optical properties or structures of tissue or turbid medium at one or more wavelengths via 1) detection at a single spatial location on the surface of a turbid medium (such as tissue) under two or more structured light conditions or 2) detection at two or more spatial locations on the surface under a single structured light condition.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 158.22K | Year: 2012

DESCRIPTION (provided by applicant): Diabetes mellitus affected 285 million adults worldwide in 2010 and is expected to increase in prevalence to 439 million people by the year 2030. Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as 15 to 25% of subjects with type 1 and 2 during their lifetime. In fact, roughly 85% of all lower extremity amputations in patients with diabetes mellitus are preceded by a foot ulcer. Untreated diabetic foot ulceration and subsequent amputation has a profound impact on the quality of life of the diabetic patient. Finally, in 2007, the treatment of diabetes and its complications in the United States generated at least 116 billion in direct costs; at least 33% of these costs were linked to thetreatment of foot ulcers. Tissue perfusion, oximetry, and hydration have been shown to predict ulcer healing and formation. These quantities provide insight into the metabolism, microstructure and health of the skin. One promising technology for measuringlocal tissue perfusion, oxygenation, hydration, and microstructure 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 quantitativedetermination of the optical properties and in-vivo concentrations of chromophores over a wide field-of-view. More importantly, MI can also be used to measure the tissue's reduced scattering coefficient and thus gain insight into microstructural changes in the tissue during ulcer formation and healing due to collage scarring, callus formation, necrosis, or inflammation. The central aim of the proposed research is to prove Modulated Imaging (MI) as a means to predict/monitor complications of the diabetic foot. We propose to develop two-layer computational techniques that will enhance the accuracy and precision of data obtained from foot skin having strong melanin pigmentation or thick callus. Once this MI system, algorithm, and software have been validated on tissue simulating phantoms, we will collect data from subjects exhibiting diabetic foot ulceration. A predictive model for ulcer formation and healing will be developed using this data. Results from this pilot study will be used to carefully design a Phase II study to establish the predictive power of MI-based models to predict ulcer formation and healing. PUBLIC HEALTH RELEVANCE: Foot ulceration continues to be a major co-morbidity of diabetes and afflicts as many as 15 to 25% of subjects with type 1 and type 2 during their lifetime. We propose to use novel imaging technology (Modulated Imaging) to facilitate prediction of ulcer formation or non-healing. Our technology has the potential to significantly reduce the human and financial cost of diabetic foot ulceration.


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 Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.23M | Year: 2013

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 further the development of a device that exploits a new imaging technique known as Modulated Imaging MI and to benchmark the sensitivity of this device to provide objective parameters that can be used to determine status of in vivo tissue enabling quantitative insight into disease progression and therapeutic response We believe the value of this technology will be particularly strong in its application toward acute an chronic wound assessment Modulated Imaging employs patterned illumination to non invasively obtain subsurface images of biological tissues Recently developed under the Laser and Medical Microbeam Program LAMMP an NIH NIBIB P Biomedical Technology Resource Center 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 MI can be used to quantitatively determine the in vivo concentrations of chromophores that are relevant to tissue health namely oxy and deoxy hemoglobin and water Modulated Imaging 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 over a wide field x cm and appropriate for deployment at clinical sites It will possess sufficient spatio temporal resolution to study both fast i e andlt s timescale and localized i e andlt mm events at depths of several millimeters in thick tissues with application areas such as chronic wound healing pressure sore staging burn assessment and reconstructive surgery To achieve this we will design and deploy to clinical collaborators a final MI system platform enabling turn key clinical research The proposed research will include the following steps Design and fabricate a clinic ready Modulated Imaging hardware platform with increased field of view spectral multiplexing improved stability and enhanced ease of use Develop clinic friendly software with automated analysis and refined algorithms Develop and perform internal and external validation and verification processes and procedures and Conduct in vivo evaluations to establish benchmarks of performance and sensitivity for quantitative hemoglobin and water parameter recovery Upon successful completion of the Phase II research outlined herein we intend to rigorously pursue Phase III clinical studies k device clearance and ultimate commercialization of our final OxImagerandquot product PUBLIC HEALTH RELEVANCE We propose to develop a clinic ready hardware and software 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 earlier detection and more accurate diagnosis of skin diseases doctors and nurses may intervene and perform more timely procedures to avoid permanent tissue damage and costly therapies and eliminate unnecessary additional time in the hospital Applications include reducing unnecessary wound care procedures such as treatment of bed sores amputations in diabetic and trauma patients and skin grafting in burn patients


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: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.02M | Year: 2016

ABSTRACT Diabetes mellitus affected million adults worldwide in and is expected to increase in prevalence to million people by the year Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as of subjects with type and diabetes during their lifetime Lower limb amputations due to poor DFU management are a global burden that is associated with a year mortality rate and cumulatively costs the system approximately $ per patient Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to quantitatively track foot health and assess treatment outcomes The broad goal of this research is to develop Modulated Imaging a new clinically viable tool which provides quantitative insight into disease stage progression and therapeutic response into a clinically viable tool for screening and managing diabetic foot ulcers MI is a non contact imaging technology that determines the in vivo concentrations of subsurface chromophores relevant to tissue health i e hemoglobin oxygenation edema and scattering The goal of this proposal is to develop a user friendly dedicated MI platform system for studying the value of MI derived biometrics like hemoglobin oxygenation and scattering in the diabetic foot In this Phase II program we will build a DFU MI device and perform three pilot studies to assess the capability of our technology to impact diabetic foot care First we will characterize vascular reactivity in control and feet considered at risk for ulcer to determine normative MI biometrics Second we will study our ability to predict new wound formation in feet that are considered in remission but with a andgt chance of re ulceration Finally we will study lower limb perfusion changes after vascular intervention for and existing wound to assess efficacy prior to wound closure Our Phase II research will determine the insertion point of MI technology into DFU clinical care and provide insight to future Phase III clinical study hypotheses and designs in order to build a medical imaging device with indications specific to wound prediction and healing NARRATIVE Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to monitor progression The goal of this research is to develop Modulated Imaging a new optical technology which provides quantitative insight into disease status and therapeutic response into a clinically viable tool for screening and managing diabetic foot ulcers


Patent
Modulated Imaging, Inc. | Date: 2014-11-11

An apparatus for turbid sample measurement comprising a plurality of light sources for illuminating a turbid sample target area with non-spatial structured light, a projection system for illuminating the turbid sample target area with spatial structured light, a sensor for collecting light from the turbid sample target area, and a processor to analyze the data captured by the sensor to yield scattering and absorption coefficients of the turbid sample. A method comprises illuminating the sample with spatial structured light, collecting light reflected from the sample at a number of wavelengths, illuminating the sample with non-spatial structured light, collecting light reflected from the sample at a number of wavelengths, and combining the measurements of the collected light to obtain the optical properties of the sample and/or the concentration of absorbing or fluorescent molecules. The wavelengths of the spatial and non-spatial light sources are preferably different.


Patent
Modulated Imaging, Inc. | Date: 2013-11-07

An apparatus for turbid sample measurement comprising a plurality of light sources for illuminating a turbid sample target area with non-spatial structured light, a projection system for illuminating the turbid sample target area with spatial structured light, a sensor for collecting light from the turbid sample target area, and a processor to analyze the data captured by the sensor to yield scattering and absorption coefficients of the turbid sample. A method comprises illuminating the sample with spatial structured light, collecting light reflected from the sample at a number of wavelengths, illuminating the sample with non-spatial structured light, collecting light reflected from the sample at a number of wavelengths, and combining the measurements of the collected light to obtain the optical properties of the sample and/or the concentration of absorbing or fluorescent molecules. The wavelengths of the spatial and non-spatial light sources are preferably different.

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