Instruments and methods for performing non-invasive measurements of analyte concentrations and for monitoring, analyzing and regulating tissue status, such as tissue glucose levels.

Non-invasive tissue glucose level monitoring

Methods and systems for providing data communication in medical systems are disclosed including a data communication unit to transmit one or more signals related to the monitored analyte level received from the analyte sensor to a remote device.

Analyte monitoring system and methods

Embodiments of the present disclosure include a handheld multi-parameter patient monitor capable of determining multiple physiological parameters from the output of a light sensitive detector capable of detecting light attenuated by body tissue. For example, in an embodiment, the monitor is capable of advantageously and accurately displaying one or more of pulse rate, plethysmograph data, perfusion quality, signal confidence, and values of blood constituents in body tissue, including for example, arterial carbon monoxide saturation (“HbCO”), methemoglobin saturation (“HbMet”), total hemoglobin (“Hbt”), arterial oxygen saturation (“SpO2”), fractional arterial oxygen saturation (“SpaO2”), or the like. In an embodiment, the monitor displays a line associated with a patient wellness level.

Noninvasive multi-parameter patient monitor

A positioner, such as an elastic sock, is fitted with an optical probe, preferably designed for pulse oximetry. The sock preferably substantially forms to the shape of a wearer's foot or hand. In addition, the sock preferably comprises at least one positioning portion. According to one embodiment, the positioning portion is configured to receive at least a wearer's great toe, thumb, or finger, such that the sock maintains substantially opposing alignment of an emitter and a detector. Alternatively, the positioner may comprise a toecap, a glove, or a mitten. The positioner may also advantageously be fitted with a timer circuit, preferably providing an alarm at predetermined intervals.

Elastic sock for positioning an optical probe

The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

Method of calibrating an analyte-measurement device, and associated methods, devices and systems

Disclosed is a method and apparatus for measuring an analyte in a tissue of a subject. The method comprises contacting the tissue with electromagnetic radiation having a first excitation wavelength, wherein the first excitation wavelength is substantially equal to an absorption wavelength of a temperature probe within the tissue. The temperature probe and the analyte are sufficiently proximate to one another that energy deposited into one by absorption of radiation is transferred to the other. The Raman spectra emitted by the tissue are collected and analyzed to determine a concentration of analyte present in the tissue. The analysis can comprise measuring the Raman spectra associated with the temperature probe. In addition, the method can include simultaneously contacting the tissue with electromagnetic radiation having the first excitation wavelength and with electromagnetic radiation having a second excitation wavelength, wherein the second excitation wavelength is substantially equal to an absorption wavelength of the analyte. The analysis comprises comparing the spectra emitted in response to the first excitation wavelength in the presence and in the absence of the second excitation wavelength. In another embodiment, the analysis comprises measuring the anti-Stokes component of the Raman spectra associated with the analyte. The method provides a non-invasive measurement of blood glucose, using hemoglobin as the temperature probe.

Method for non-invasive measurement of an analyte

Disclosed is a tissue modulation device (100) for use during spectroscopy of tissue of a subject. In one embodiment, the device comprises an inner sheath (220), an outer sheath (210) and a window (140) disposed through the inner (220) and outer (210) sheaths, wherein the inner (220) and outer sheaths comprise a sufficiently flexible material that the device can be secured to a region of tissue to be spectroscopically probed, wherein the inner (220) and outer (210) sheaths are joined to one another so that at least one temperature regulating element (110) can be disposed between the inner (220) and outer sheaths (210), and wherein the window (140) is sufficiently transparent that electromagnetic radiation can be delivered to and collected from an underlying tissue through the inner (220) and outer (210) sheaths. The invention additionally provides a method of modulating temperature of tissue in a subject to be spectroscopically probed. In a preferred embodiment, the method comprises applying a tissue modulation device of the invention to the tissue, passing current through the temperature regulating element (110) so as to elevate or lower the temperature of the tissue, and passing electromagnetic radiation through the window (140) of the device. Preferably, spectroscopic probing is performed when the temperature of the tissue has been elevated or lowered and when the temperature of the tissue is not elevated or lowered. The method can further comprise collecting Raman spectra emitted by the tissue. The invention also provides a method for determining phase transition, and a method for determining lipid content and identity and protein content in a tissue of a subject.

M. Charles Peterson

Papers

Method for non-invasive measurement of an analyte

Apparatus and method for thermal tissue modulation