David Benaron, Ilian Parachikov, Wai-Fung Cheong, Shai Friedland, Boris Rubinsky, David Otten, Frank Liu, Carl Levinson, Aileen Murphy, Yair Talmi, James Weersing, Joshua Duckworth, Uwe Hörchner, Eben Kermit
We develop a clinical visible-light spectroscopy (VLS) tissue oximeter. Unlike currently approved near-infrared spectroscopy (NIRS) or pulse oximetry (SpO2%), VLS relies on locally absorbed, shallow-penetrating visible light (475 to 625 nm) for the monitoring of microvascular hemoglobin oxygen saturation (StO2%), allowing incorporation into therapeutic catheters and probes. A range of probes is developed, including noncontact wands, invasive catheters, and penetrating needles with injection ports. Data are collected from: 1. probes, standards, and reference solutions to optimize each component; 2. ex vivo hemoglobin solutions analyzed for StO2% and pO2 during deoxygenation; and 3. human subject skin and mucosal tissue surfaces. Results show that differential VLS allows extraction of features and minimization of scattering effects, in vitro VLS oximetry reproduces the expected sigmoid hemoglobin binding curve, and in vivo VLS spectroscopy of human tissue allows for real-time monitoring (e.g., gastrointestinal mucosal saturation 69±4%, n=804; gastrointestinal tumor saturation 45±23%, n=14; and p<0.0001), with reproducible values and small standard deviations (SDs) in normal tissues. FDA approved VLS systems began shipping earlier this year. We conclude that VLS is suitable for the real-time collection of spectroscopic and oximetric data from human tissues, and that a VLS oximeter has application to the monitoring of localized subsurface hemoglobin oxygen saturation in the microvascular tissue spaces of human subjects.
David Benaron, Ilian Parachikov, Wai-Fung Cheong, Shai Friedland, Joshua Duckworth, David Otten, Boris Rubinsky, Uwe Horchner, Eben Kermit, Frank Liu, Carl Levinson, Aileen Murphy, John Price, Yair Talmi, James Weersing
We report the development of a general, quantitative, and localized visible light clinical tissue oximeter, sensitive to both hypoxemia and ischemia. Monitor design and operation were optimized over four instrument generations. A range of clinical probes were developed, including non-contact wands, invasive catheters, and penetrating needles with injection ports. Real-time data were collected (a) from probes, standards, and reference solutions to optimize each component, (b) from ex vivo hemoglobin solutions co-analyzed for StO2% and pO2 during deoxygenation, and (c) from normoxic human subject skin and mucosal tissue surfaces. Results show that (a) differential spectroscopy allows extraction of features with minimization of the effects of scattering, (b) in vitro oximetry produces a hemoglobin saturation binding curve of expected sigmoid shape and values, and (c) that monitoring human tissues allows real-time tissue spectroscopic features to be monitored. Unlike with near-infrared (NIRS) or pulse oximetry (SpO2%) methods, we found non-pulsatile, diffusion-based tissue oximetry (StO2%) to work most reliably for non-contact reflectance monitoring and for invasive catheter- or needle-based monitoring, using blue to orange light (475-600 nm). Measured values were insensitive to motion artifact. Down time was non-existent. We conclude that the T-Stat oximeter design is suitable for the collection of spectroscopic data from human subjects, and that the oximeter may have application in the monitoring of regional hemoglobin oxygen saturation in the capillary tissue spaces of human subjects.
The effectiveness of cryosurgery in treating tumors is highly dependent on knowledge of freezing extent, and therefore relies heavily on real-time imaging techniques for monitoring. Electrical impedance tomography (EIT), which utilizes tissue impedance variation to construct an image, is very well-suited to cryosurgery since frozen tissue impedance is much higher than that of unfrozen tissue. In this study, we develop numerical models to evaluate the theoretical ability of EIT to image cryosurgery. We begin in the simplified 2D arena, and then extend this line of study to the more appropriate 3D realm. Our simulated finite element phantoms and pixel-based Newton-Raphson reconstruction algorithms were able to produce easily identifiable images of frozen regions within tissue. We hope that these findings will serve as a stepping stone in developing EIT as a promising supplement to existing cryosurgical monitoring techniques.
David Benaron, Boris Rubinski, Susan Hintz, Joshua Duckworth, Aileen Murphy, John Price, Frank Liu, David Otten, David Stevenson, Wai-Fung Cheong, Eben Kermit
Each tissue has a unique spectral signature (e.g. liver looks distinct from bowel due to differences in both absorbance and in the way the tissue scatters light). Therefore, we suspect that automated discrimination among tissue types (e.g. blood, nerve, artery, vein, muscle) or tissue state (frozen, unfrozen, viable, dead) is feasible. In this study, we investigated our ability to detect hidden structures (such as blood vessels) or events (such as tissue ablation via freezing) using optical systems. For blood vessel localization, a key step in vascular access, we resolved the component concentration of hemoglobin measured within the tissue, and found that blood vessel depth and direction could be determined. For freezing detection, we found that changes in effective absorbance during freezing allowed the freezing process to be monitored spectroscopically. Such optical techniques may usher in use of light-assisted medical diagnosis, leading to automated and portable diagnostic devices which enable real-time diagnostics and monitoring during medical interventions, such as cryoablation or vascular access.
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