Abstract: Several embodiments of the present invention are generally directed to medical visualization systems that comprise combinations of disposable and reusable components, such as catheters, functional handles, hubs, optical devices, etc. Other embodiments of the present invention are generally directed to features and aspects of an in-vivo visualization system that comprises an endoscope having a working channel through which a catheter having viewing capabilities is routed. the catheter may obtain viewing capabilities by being constructed as a vision catheter or by having a fiberscope or other viewing device selectively routed through one of its channels. The catheter is preferably of the steerable type so that the distal end of the catheter may be steered from its proximal end as it is advanced with the body. A suitable use for the in-vivo visualization system includes but is not limited to diagnosis and/or treatment of the duodenum, and particularly the biliary tree.

Abstract: The present invention provides methods, devices, and systems for in vivo treatment of cell proliferative disorders. Included is a method of treating tissue with electrical energy, the method comprising: delivering electrical energy to tissue using one or more electroporation devices comprising one or more electrodes; and cooling the tissue, surrounding tissue, one or more of the electrodes, or one or more of the electroporation devices to minimize heating. In embodiments, the invention can be used to treat solid tumors, such as brain tumors, and in some embodiments, exemplary methods rely on non-thermal irreversible electroporation (IRE) to cause cell death in treated tumors.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: Provided herein are devices, systems, and methods for monitoring lesion or treated area in a tissue during focal ablation or cell membrane disruption therapy.

Abstract: The present invention provides methods, devices, and systems for in vivo treatment of cell proliferative disorders. Included is a method of treating tissue with electrical energy, the method comprising: delivering electrical energy to tissue using one or more electroporation devices comprising one or more electrodes; and cooling the tissue, surrounding tissue, one or more of the electrodes, or one or more of the electroporation devices to minimize heating. In embodiments, the invention can be used to treat solid tumors, such as brain tumors, and in some embodiments, exemplary methods rely on non-thermal irreversible electroporation (IRE) to cause cell death in treated tumors.

Abstract: The present invention relates to the field of medical treatment of diseases and disorders, as well as the field of biomedical engineering. Embodiments of the invention relate to the delivery of Irreversible Electroporation (IRE) through the vasculature of organs to treat tumors embedded deep within the tissue or organ, or to decellularize organs to produce a scaffold from existing animal tissue with the existing vasculature intact. In particular, methods of administering non-thermal irreversible electroporation (IRE) in vivo are provided for the treatment of tumors located in vascularized tissues and organs. Embodiments of the invention further provide scaffolds and tissues from natural sources created using IRE ex vivo to remove cellular debris, maximize recellularization potential, and minimize foreign body immune response. The engineered tissues can be used in methods of treating subjects, such as those in need of tissue replacement or augmentation.

Abstract: Chronic Kidney Disease (CKD) is characterized by the progressive loss of renal function which eventually leads to End Stage Renal Disease (ESRD). CKD affects roughly 30 million Americans, costs billions of dollars in healthcare spending annually, and leaves thousands of patients reliant on burdensome dialysis treatments while waiting for a transplant. Fortunately, CKD may be controllable if diagnosed early in the disease progression. RAMETRIX™ is a novel public health screening technology for early diagnosis and detection of CKD. This technology uses Raman spectroscopy and chemometrics to analyze the molecular composition of urine and other biological fluids. RAMETRIX™ is a fast, non-invasive, accurate, and inexpensive diagnostic tool that can revolutionize the way healthcare providers detect and treat CKD. The RAMETRIX™ AutoScanner is a system enabling more efficient sample processing in large-scale settings such as hospitals and medical laboratories.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: Provided herein are devices, systems, and methods for monitoring lesion or treated area in a tissue during focal ablation or cell membrane disruption therapy.

Abstract: A system and method for monitoring the health of dialysis patients with Raman spectroscopy measurements of one or more target analytes is described. The methods include irradiating one or more fluids of interest with light to produce one or more spectrum and detecting the spectrum with a detector. The fluids of interest are preferably those related to dialysis, including hemodialysis and peritoneal dialysis. In a preferred embodiment, the fluids are irradiated with monochromatic light, and one or more Raman spectra are detected as a result of the irradiation. The fluids may be irradiated within the dialysis tubing itself, or removed from the dialysis tubing and irradiated in a separate chamber. The Raman spectra of one or more target analytes of a dialysis patient may be followed over time or compared to one or more reference spectra, thereby providing information on the health of dialysis patients.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: A system and method for monitoring the health of dialysis patients with Raman spectroscopy measurements of one or more target analytes is described. The methods include irradiating one or more fluids of interest with light to produce one or more spectrum and detecting the spectrum with a detector. The fluids of interest are preferably those related to dialysis, including hemodialysis and peritoneal dialysis. In a preferred embodiment, the fluids are irradiated with monochromatic light, and one or more Raman spectra are detected as a result of the irradiation. The fluids may be irradiated within the dialysis tubing itself, or removed from the dialysis tubing and irradiated in a separate chamber. The Raman spectra of one or more target analytes of a dialysis patient may be followed over time or compared to one or more reference spectra, thereby providing information on the health of dialysis patients.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: The present invention comprises methods of detecting and classifying COVID-19 disease using Raman spectra obtained from subject urine samples. Raman spectra from subject urine samples are analyzed using models prepared from reference Raman samples obtained from urine samples of individuals with and without COVID-19. The spectral fingerprints of urine from subjects with and without COVID-19 allow for identification of disease-associated changes in urine molecular composition.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: The present invention is a system to continuously monitor, in real-time, the small molecules being dialyzed during hemodialysis treatment using Raman spectroscopy and press control algorithms. By monitoring the treatment, the amount of water needed per dialysis treatment is drastically reduced by optimizing analyte saturation and removal of wastes. This will significantly conserve water and reduce the cost of dialysis treatments, possibly reducing the amount of time necessary for dialysis treatment, improving quality of life for patients during and after treatment, and reducing the costs of building new treatment centers as well as operating costs.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: The present invention is a system to continuously monitor, in real-time, the small molecules being dialyzed during hemodialysis treatment using Raman spectroscopy and press control algorithms. By monitoring the treatment, the amount of water needed per dialysis treatment is drastically reduced by optimizing analyte saturation and removal of wastes. This will significantly conserve water and reduce the cost of dialysis treatments, possibly reducing the amount of time necessary for dialysis treatment, improving quality of life for patients during and after treatment, and reducing the costs of building new treatment centers as well as operating costs.

Abstract: Chronic Kidney Disease (CKD) is characterized by the progressive loss of renal function which eventually leads to End Stage Renal Disease (ESRD). CKD affects roughly 30 million Americans, costs billions of dollars in healthcare spending annually, and leaves thousands of patients reliant on burdensome dialysis treatments while waiting for a transplant. Fortunately, CKD may be controllable if diagnosed early in the disease progression. RAMETRIX™ is a novel public health screening technology for early diagnosis and detection of CKD. This technology uses Raman spectroscopy and chemometrics to analyze the molecular composition of urine and other biological fluids. RAMETRIX™ is a fast, non-invasive, accurate, and inexpensive diagnostic tool that can revolutionize the way healthcare providers detect and treat CKD. The RAMETRIX™ AutoScanner is a system enabling more efficient sample processing in large-scale settings such as hospitals and medical laboratories.

Abstract: Baseline correction in Raman spectroscopy is a procedure that eliminates/reduces the background signals generated by residual Rayleigh scattering or fluorescence. Provided is a novel baseline correction procedure called the Iterative Smoothing-splines with Root Error Adjustment (ISREA) that has three distinct advantages. First, ISREA uses smoothing splines, which are more flexible than polynomials and capable of capturing complicated trends over the whole spectral domain, to estimate the baseline. Second, ISREA mimics the asymmetric square root loss and removes the need of a threshold. Finally, ISREA avoids the direct optimization of a non-convex loss function by iteratively updating prediction errors and refitting baselines. Through extensive numerical experiments on a wide variety of spectra including simulated spectra, mineral spectra, and dialysate spectra, the present inventors show that ISREA is simple, fast, and can yield consistent and accurate baselines that preserve all the meaningful Raman peaks.