The First-in-Man “Si Se Puede” Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy

Montero-Baker, Miguel; Au-Yeung, Kit Yee; Wisniewski, Natalie A.; Gamsey, Soya; Morelli-Alvarez, Luis; Mills, Joseph L.; Campos, Marianella; Helton, Kristen

doi:10.1016/j.jvs.2014.12.060

Cited by 54 publications

(54 citation statements)

References 28 publications

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“…Specifically, we have performed studies with live subjects (animal and human models) to assess the potential for successful in vivo application of similar materials. These comparable sensing systems consist of implantable hydrogel-based bioresponsive materials with longer-wavelength benzoporphyrin phosphors (with red-light excitation, compared to the green-excited phosphors used here) along with a complementary phosphorescence detection instrument with red LED and filters that match the long wavelength emission [23,36]. These studies describe a strategy that appears effective for in vivo use and should be applicable to the AnA hydrogels described here, but they will similarly require a shift to longer-wavelength phosphors to enable deeper tissue penetration.…”

Section: Resultsmentioning

confidence: 99%

Composite Hydrogels with Engineered Microdomains for Optical Glucose Sensing at Low Oxygen Conditions

2017

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There is a growing need for advanced tools that enable frequent monitoring of biomarkers for precision medicine. In this work, we present a composite hydrogel-based system providing real-time optical bioanalyte monitoring. The responsive material, alginate-in-alginate (AnA), is comprised of an alginate hydrogel with embedded bioactive, nanofilm-coated phosphorescent microdomains; palladium tetracarboxyphenylporphyrin serves as an optical indicator, glucose oxidase as a model enzyme, and layer-by-layer deposited polyelectrolyte multilayers (PEMs) as the diffusion barrier. Glutaraldehyde crosslinking of the nanofilms resulted in a dramatic reduction in glucose diffusion (179%) while oxygen transport was not significantly affected. The responses of the AnA hydrogels to step changes of glucose at both ambient and physiological oxygen levels were evaluated, revealing controlled tuning of sensitivity and dynamic range. Stability, assessed by alternately exposing the responsive AnA hydrogels to extremely high and zero glucose concentrations, resulted in no significant difference in the response over 20 cycles. These AnA hydrogels represent an attractive approach to biosensing based on biocompatible materials that may be used as minimally-invasive, implantable devices capable of optical interrogation. The model glucose-responsive composite material studied in this work will serve as a template that can be translated for sensing additional analytes (e.g., lactate, urea, pyruvate, cholesterol) and can be used for monitoring other chronic conditions.

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Section: Resultsmentioning

confidence: 99%

Composite Hydrogels with Engineered Microdomains for Optical Glucose Sensing at Low Oxygen Conditions

2017

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“…Several hundred sensors have been optimized in mice, rats, and pigs. Over 90 sensors have been tested in humans including 50 in healthy volunteers and 40 in critical limb ischemia patients [21]. …”

Section: Methodsmentioning

confidence: 99%

Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia

Wisniewski

Nichols

Gamsey

et al. 2017

Advances in Experimental Medicine and Biology

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We describe a simple method of tracking oxygen in real-time with injectable, tissue-integrating microsensors. The sensors are small (500 μm × 500 μm × 5 mm), soft, flexible, tissue-like, biocompatible hydrogels that have been shown to overcome the foreign body response for longterm sensing. The sensors are engineered to change luminescence in the presence of oxygen or other analytes and function for months to years in the body. A single injection followed by noninvasive monitoring with a hand-held or wearable Bluetooth optical reader enables intermittent or continuous measurements. Proof of concept for applications in high altitude, exercise physiology, vascular disease, stroke, tumors, and other disease states have been shown in mouse, rat and porcine models. Over 90 sensors have been studied to date in humans. These novel tissueintegrating sensors yield real-time insights in tissue oxygen fluctuations for research and clinical applications.

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“…Wearable devices are easily ignored and are useless if not actually worn. Implantable monitors (25, 26) circumvent this problem, but even minimally invasive devices may be met with resistance. Fortunately, noninvasive high-frequency health monitoring can be achieved passively during routine daily activities, overcoming the obstacle of actively modifying human behavior (Fig.…”

Section: Passive Monitoring and The Smart Home: The Engine That Nevermentioning

confidence: 99%

Toward achieving precision health

et al. 2018

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Health care systems primarily focus on patients after they present with disease, not before. The emerging field of precision health encourages disease prevention and earlier detection by monitoring health and disease based on an individual’s risk. Active participation in health care can be encouraged with continuous health-monitoring devices, providing a higher-resolution picture of human health and disease. However, the development of monitoring technologies must prioritize the collection of actionable data and long-term user engagement.

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The First-in-Man “Si Se Puede” Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy

Cited by 54 publications

References 28 publications

Composite Hydrogels with Engineered Microdomains for Optical Glucose Sensing at Low Oxygen Conditions

Composite Hydrogels with Engineered Microdomains for Optical Glucose Sensing at Low Oxygen Conditions

Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia

Toward achieving precision health

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