Abstract: The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyte is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.

Abstract: A heatsink having tapered geometry that improves passive cooling efficiency is discussed. A tapered geometry between heatsink heat dissipation elements, as a function of distance along a z-axis opposing gravity, decreases resistance to rarification of passively flowing cooling gas upon heating. Thus, the tapered heatsink elements result in higher velocity of gas flow and increased cooling efficiency of the heatsink. Optionally, the heatsink is made from a thermally conductive polymer allowing the heatsink to be created in complex shapes using injection molding.

Abstract: The invention provides a targeting system used to direct a measuring system to a targeted sample site or volume. The targeting system increases analyte estimation performance by increasing precision and accuracy of sampling and/or by targeting an analyte rich tissue volume.

Abstract: The invention relates to noninvasive analyte property determination. More particularly, the invention relates to a method and apparatus for performing conditional additional acquisition of noninvasive spectra to improve analyzer performance. Conditional additional data acquisition is used to confirm, update, and/or supplement spectral data.

Abstract: This invention provides a method and apparatus that corrects for tissue related interference calibration and/or measurement of biological parameters noninvasively. The invention concerns such terms as outlier identification, filtering, spectral correction, and baseline subtraction steps that, when used together, provides for noninvasive measurement of biological parameters, such as glucose concentration.

Abstract: The invention comprises transformation of a section of a data block independently of the transformation of separate or overlapping data blocks to determine a property related to the original matrix, where each of the separate or overlapping data blocks are derived from an original data matrix. The transformation enhances parameters of a first data block over a given region of an axis of the data matrix, such as signal-to-noise, without affecting analysis of a second data block derived from the data matrix. This allows for enhancement of analysis of an analyte property, such as concentration, represented within the original data matrix. A separate decomposition and factor selection for each selected data matrix is performed with subsequent score matrix concatenization. The combined score matrix is used to generate a model that is subsequently used to estimate a property, such as concentration represented in the original data matrix.

Abstract: An optical sampling interface system is disclosed that minimizes and compensates for errors that result from sampling variations and measurement site state fluctuations. Embodiments of the invention use a guide that does at least one of, induce the formation of a tissue meniscus, minimize interference due to surface irregularities, control variation in the volume of tissue sampled, use a two-part guide system, use a guide that controls rotation of a sample probe and allows z-axis movement of the probe, use a separate base module and sample module in conjunction with a guide, and use a guide that controls rotation. Optional components include an occlusive element and a coupling fluid.

Abstract: The invention comprises method and apparatus for fluid delivery between a sample probe and a sample. The fluid delivery system includes: a fluid reservoir, a delivery channel, a manifold or plenum, a channel or moat, a groove, and/or a dendritic pathway to deliver a thin and distributed layer of a fluid to a sample probe head and/or to a sample site. The fluid delivery system reduces sampling errors due to mechanical tissue distortion, specular reflectance, probe placement, and/or mechanically induced sample site stress/strain associated with optical sampling of the sample.

Abstract: The invention relates to a heatsink. More particularly, the invention relates to a heatsink having tapered geometry that improves passive cooling efficiency. A tapered geometry between heatsink heat dissipation elements, as a function of distance along a z-axis opposing gravity, decreases resistance to rarification of passively flowing cooling gas upon heating. Thus, the tapered heatsink elements result in higher velocity of gas flow and increased cooling efficiency of the heatsink. Optionally, the heatsink is made from a thermally conductive polymer allowing the heatsink to be created in complex shapes using injection molding.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

Abstract: A method and apparatus are provided for noninvasive sampling. More particularly, the method and apparatus relate to control of motion of an optical sample probe interface relative to a tissue sample site. A dynamic probe interface, is used to collect spectra of a targeted sample, control positioning of the sample probe relative to the tissue sample in terms of at least one of x-, y-, and z-axes, and/or control of sample tissue displacement to minimize spectral variations resulting from the sampling process and increase analyte property estimation precision and accuracy.

Abstract: A method and apparatus for noninvasive glucose measurement measures glucose indirectly from the natural response of tissue to variations in analyte concentration. The indirect measurement method utilizes factors affected by or correlated with the concentration of glucose, such as refractive index, electrolyte distribution or tissue scattering. Measurement reliability is greatly improved by stabilizing optical properties of the tissue at the measurement site, thus blood perfusion rates at the sample site are regulated. Perfusion is monitored and stabilized by spectroscopically measuring a control parameter, such as skin temperature, that directly affects perfusion. The control parameter is maintained in a range about a set point, thus stabilizing perfusion. Skin temperature is controlled using a variety of means, including the use of active heating and cooling elements, passive devices, such as thermal wraps, and through the use of a heated coupling medium having favorable heat transfer properties.

Abstract: A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

Abstract: The invention relates generally to the extraction and/or presentation of glucose concentrations estimated as a function of time into a format that facilitates conveyance of the underlying information. More particularly, glucose concentration histories are presented in terms of risk of behavior, in a video format, and/or in an audio format. The reduction of data into video format, selected by time period, cluster, or glucose concentration response, into an animated or video presentation allows diagnosis and treatment information to be more readily determined and used. Alternatively, glucose concentrations are output through a voice synthesizer or an earcon. These information presentations are useful for both the medical professional and the end user. The information presentation is preferably used with a noninvasive, implantable, semi-continuous, and/or continuous analyte analyzer, such as a glucose concentration analyzer.

Abstract: The invention comprises a method and apparatus for enhancing the analysis of noninvasive spectra, resulting in improved analytical performance. More particularly, the invention comprises a method and apparatus for processing noninvasive spectra with an analyte filter that preferably rejects variation likely to be detrimental to the measurement system, while passing signal that probabilistically is unique to the target analyte. Subsequently, the analyte filtered data are used to estimate an analyte property, such as a glucose concentration, in the presence of noise, interferences, state changes, and/or across analyzers.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

Abstract: A method and apparatus for easing the use of an optically based noninvasive analyzer is presented. More particularly, a simplified algorithm is used that removes the daily requirement of collecting and using a noninvasive spectrum to update a calibration model. In another embodiment, a guide is used to substantially reduce variation in sample probe placement in relation to a skin tissue sampling site, resulting in the ability to maintain calibration performance with the use of a reference analyte concentration, with or without the use of a reference spectrum collected nearby in time.

Abstract: A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

Abstract: The invention relates to a noninvasive analyzer and a method of using information determined at least in part from in-vitro spectra of tissue phantoms or analyte solutions to aid in the development of a noninvasive glucose concentration analyzer and/or in the analysis of noninvasive spectra resulting in glucose concentration estimations in the body. The preferred apparatus is a spectrometer that includes a base module and a sample module that is semi-continuously in contact with a human subject and that collects spectral measurements which are used to determine a biological parameter in the sampled tissue, such as glucose concentration. Collection of in-vitro samples is, optionally, performed on a separate instrument from the production model allowing the measurement technology to be developed on a research grade instrument and used or transferred to a target product platform or production analyzer for noninvasive glucose concentration estimation.

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.