Thomas B. Blank - Chandler AZ George Acosta - Phoenix AZ Mutua Mattu - Gilbert AZ Stephen L. Monfre - Gilbert AZ
Assignee:
Instrumentation Metrics, Inc. - Chandler AZ
International Classification:
A61B 500
US Classification:
600344, 600310, 600322, 385137
Abstract:
A fiber optic probe placement guide minimizes sampling errors during optical sampling of a tissue measurement site by allowing repeatable placement of the fiber optic probe at a targeted tissue measurement site. A mount, contoured to conform to the shape of the tissue measurement site, typically the arm of a human subject, contains an aperture for receiving a fiber optic probe. A temperature probe on the contact surface of the guide allows for monitoring of surface temperature within the vicinity of the tissue measurement site. Crosshair slots in the mount align with corresponding crosshairs at the tissue measurement site. The fiber optic probe placement guide is affixed to the tissue measurement site by means of adhesive tape or fastenable straps. Guideposts on the external surface of the mount are received by corresponding receptacles on a subject interface bearing the fiber optic probe to facilitate alignment of the fiber optic probe with the aperture.
Intra-Serum And Intra-Gel For Modeling Human Skin Tissue
Kevin H. Hazen - Gilbert AZ James Matthew Welch - Tempe AZ Stephen F. Malin - Phoenix AZ Timothy L. Ruchti - Gilbert AZ Alexander D. Lorenz - Phoenix AZ Tamara L. Troy - Chandler AZ Suresh Thennadil - Tempe AZ Thomas B. Blank - Chandler AZ
Assignee:
Instrumentation Metrics, Inc. - Chandler AZ
International Classification:
G01N 3100
US Classification:
436 8, 436 71, 436164, 436166, 738664, 2524081
Abstract:
The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na , K and Cl. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analytes concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, m and m. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body. In particular, knowledge may be gained on net analyte signal, photon depth of penetration, photon radial diffusion, photon interaction between tissue layers, photon density (all as a function of frequency) and on instrument parameter specifications such as resolution and required dynamic range (A/D bits required).
Multi-Tier Method Of Classifying Sample Spectra For Non-Invasive Blood Analyte Prediction
Stephen L. Monfre - Gilbert AZ Thomas B. Blank - Chandler AZ Timothy L. Ruchti - Gilbert AZ Suresh Thennadil - Tempe AZ
Assignee:
Sensys Medical, Inc. - Chandler AZ
International Classification:
A61B 500
US Classification:
600322, 128920
Abstract:
A method of multi-tier classification and calibration in noninvasive blood analyte prediction minimizes prediction error by limiting co-varying spectral interferents. Tissue samples are categorized based on subject demographic and instrumental skin measurements, including in vivo near-IR spectral measurements. A multi-tier intelligent pattern classification sequence organizes spectral data into clusters having a high degree of internal consistency in tissue properties. In each tier, categories are successively refined using subject demographics, spectral measurement information and other device measurements suitable for developing tissue classifications. The multi-tier classification approach to calibration utilizes multivariate statistical arguments and multi-tiered classification using spectral features. Variables used in the multi-tiered classification can be skin surface hydration, skin surface temperature, tissue volume hydration, and an assessment of relative optical thickness of the dermis by the near-IR fat band. All tissue parameters are evaluated using the NIR spectrum signal along key wavelength segments.
Multi-Tier Method Of Developing Localized Calibration Models For Non-Invasive Blood Analyte Prediction
Thomas B. Blank - Chandler AZ Stephen L. Monfre - Gilbert AZ Timothy L. Ruchti - Gilbert AZ Suresh Thennadil - Tempe AZ
Assignee:
Sensys Medical, Inc. - Chandler AZ
International Classification:
A61B 500
US Classification:
600322, 128920
Abstract:
A method of multi-tier classification and calibration in noninvasive blood analyte prediction minimizes prediction error by limiting co-varying spectral interferents. Tissue samples are categorized based on subject demographic and instrumental skin measurements, including in vivo near-IR spectral measurements. A multi-tier intelligent pattern classification sequence organizes spectral data into clusters having a high degree of internal consistency in tissue properties. In each tier, categories are successively refined using subject demographics, spectral measurement information and other device measurements suitable for developing tissue classifications. The multi-tier classification approach to calibration utilizes multivariate statistical arguments and multi-tiered classification using spectral features. Variables used in the multi-tiered classification can be skin surface hydration, skin surface temperature, tissue volume hydration, and an assessment of relative optical thickness of the dermis by the near-IR fat band. All tissue parameters are evaluated using the NIR spectrum signal along key wavelength segments.
Method And Apparatus For Minimizing Spectral Effects Attributable To Tissue State Variations During Nir-Based Non-Invasive Blood Analyte Determination
Marcy R. Makarewicz - Chandler AZ Mutua Mattu - Gilbert AZ Thomas B. Blank - Chandler AZ Stephen L. Monfre - Gilbert AZ Timothy L. Ruchti - Gilbert AZ
Assignee:
Sensys Medical, Inc. - Chandler AZ
International Classification:
A61B 500
US Classification:
600322, 600334, 600474
Abstract:
A method and apparatus for minimizing confounding effects in a noninvasive in-vivo spectral measurement caused by fluctuations in tissue state monitors a selected tissue state parameter spectroscopically and maintains the selected parameter within a target range, at which spectral effects attributable to the changes in the selected parameter are minimized. The invention includes both active and passive control. A preferred embodiment of the invention provides a method and apparatus for minimizing the confounding effects in near IR spectral measurements attributable to shifts in skin temperature at a tissue measurement site. Spectroscopic monitoring of skin temperature at the measurement site provides near-instantaneous temperature readings by eliminating thermal time constants. A thermistor positioned at the measurement site provides active control. The spectrometer and the temperature control device are incorporated into a single instrument for noninvasive measurement of blood glucose concentration.
Apparatus And Method For Quantification Of Tissue Hydration Using Diffuse Reflectance Spectroscopy
Stephen L. Monfre - Gilbert AZ Timothy L. Ruchti - Gilbert AZ Thomas B. Blank - Chandler AZ Brian J. Wenzel - Cave Creek AZ
Assignee:
Sensys Medical, Inc. - Chandler AR
International Classification:
A61B 500
US Classification:
600310, 600473, 2503391, 2503418
Abstract:
An apparatus and method for non-destructively estimating a tissue property, such as hydration, of a living subject utilizes in vivo spectral measurements made by irradiating skin tissue with near infrared (NIR) light. The apparatus includes a spectroscopic instrument in conjunction with a subject interface. The resulting spectra are passed to an analyzer for further processing, which includes detecting and eliminating invalid spectral measurements, and preprocessing to increase the signal-to-noise ratio. Finally, an estimation model developed from an exemplary set of measurements is applied to predict the tissue hydration for the sample. The method of tissue hydration measurement provides additional information about primary sources of systematic tissue variability, namely, the water content of the epidermal layer of skin and the penetration depth of the incident light. Tissue hydration measurement is therefore suitable for further spectral analysis and quantification of biological and chemical compounds, such as analytes.
Classification And Screening Of Test Subjects According To Optical Thickness Of Skin
Mutua Mattu - Gilbert AZ Thomas B. Blank - Chandler AZ Marcy R. Makarewicz - Chandler AZ Branden Rosenhan - Tempe AZ
Assignee:
Sensys Medical, Inc. - Chandler AZ
International Classification:
A61B 500
US Classification:
600310, 600473, 600556
Abstract:
A method for classifying live subjects according to optical thickness of the skin is based on noninvasive, near-infrared reflectance measurements on skin tissue. An indicator of skin optical thickness is derived through analysis of the water, fat, and protein marker bands in the near infrared spectrum. The skin thickness indicator may then be used to evaluate the suitability of the subject for calibration on a standardized set of optical probes. The optical probes in the standardized set are designed to cover a range of penetration depths by varying the distance distribution between illuminator and detector fibers on each probe tip.
Intra-Serum And Intra-Gel For Modeling Human Skin Tissue
Kevin H. Hazen - Gilbert AZ James Matthew Welch - Tempe AZ Stephen F. Malin - Glendale CA Timothy L. Ruchti - Gilbert AZ Alexander D. Lorenz - Phoenix AZ Tamara L. Troy - Chandler AZ Suresh Thennadil - Tempe AZ Thomas B. Blank - Chandler AZ
Assignee:
Sensys Medical, Inc. - Chandler AZ
International Classification:
G01N 3100
US Classification:
436 8, 436 71, 436164, 436166, 738664, 2524081
Abstract:
The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na , K and Cl. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analytes concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, and. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body. In particular, knowledge may be gained on net analyte signal, photon depth of penetration, photon radial diffusion, photon interaction between tissue layers, photon density (all as a function of frequency) and on instrument parameter specifications such as resolution and required dynamic range (A/D bits required).