Cas Medical Systems, Inc.

Edwards Lifesciences Corporation

Becton Dickinson and Company Limited

Paul B Benni

Bo Chen

Karen M Duffy

Matthew Dalene

Andrew Kersey

John Gamelin

Robert James Kopotic

William Kosturko

Douglas Pirc

George Brocksieper

Krystian Gieryk

Suzanne M Carroll

Karen Duffy

A method and apparatus of non-invasively determining a blood circulatory hemoglobin value for a subject using a near-infrared spectrophotometric (NIRS) sensing device is provided. The method includes: a) non-invasively sensing tissue of the subject using the NIRS sensing device at about a time T, and determining at least one NIRS tissue totalHb value; b) acquiring at least one circulatory blood sample from the subject at about the time T; c) determining at least one blood circulatory THb value; d) calibrating the NIRS sensing device using the at least one blood circulatory THb value and the at least one MRS tissue TotalHb value; and e) determining at least one blood circulatory hemoglobin value using the calibrated NIRS sensing device and the at least one NIRS tissue totalHb value.

Method and apparatus for non-invasively measuring blood circulatory hemoglobin

A method and apparatus for monitoring a subject's autoregulation function state is provided. The method includes: a) continuously sensing a tissue region of the subject with a tissue oximeter, the sensing producing first signals, and determining frequency domain tissue oxygen parameter values; b) continuously measuring a blood pressure level of the subject using a blood pressure sensing device, the measuring producing second signals, and determining frequency domain blood pressure values; c) determining a coherence value indicative of the subject's autoregulation state in each of a plurality of different frequency bands; and d) determining a peak coherence value indicative of the subject's autoregulation state based on the determined coherence value from each of the plurality of different frequency bands.

Autoregulation system and method using tissue oximetry and blood pressure

A method and apparatus of non-invasively determining a blood circulatory hemoglobin value for a subject using a near-infrared spectrophotometric (NIRS) sensing device is provided. The method includes: a) non-invasively sensing tissue of the subject using the NIRS sensing device at about a time T1, and determining at least one NIRS tissue totalHb value; b) acquiring at least one circulatory blood sample from the subject at about the time T1; c) determining at least one blood circulatory THb value; d) calibrating the NIRS sensing device using the at least one blood circulatory THb value and the at least one NIRS tissue TotalHb value; and e) determining at least one blood circulatory hemoglobin value using the calibrated NIRS sensing device and the at least one NIRS tissue totalHb value.

Method and apparatus for non-invasively measuring circulatory hemoglobin

A method and apparatus for non-invasively determining a blood oxygen saturation level within tissue of an internal organ is provided. The method includes: applying a near infrared spectrophotometric sensor on an external surface of an organ; operating the sensor to emit light from a light source directly into the tissue of the organ at a first tissue location, and to sense the emitted light at a second tissue location, which emitted light has traveled through the tissue between the first and second tissue locations, and to produce signals representative of the intensity of the sensed emitted light; using a processor to execute instructions, which instructions cause the processor to: determine an attenuation value of the emitted light for each wavelength, and determine a blood oxygen saturation level of the organ tissue using the determined attenuation values for each of the plurality of wavelengths.

Method for spectrophotometric blood oxygenation monitoring of organs in the body

An apparatus and method for non-invasively determining a blood oxygen parameter value of a subject's tissue is provided. An embodiment of the method includes the steps of: a) providing a spectrophotometric sensor that includes a processing portion and a transducer, b) detecting at least a portion of transmitted light after passage through the subject's tissue and producing initial signal data from the detected light; and c) using the processing portion to: (i) determine a value representative of an attenuation of at least one wavelength of light detected; (ii) determine whether the representative attenuation value is outside a predefined range of attenuation values; and (iii) determine the blood oxygen parameter value using a first interrogation or an alternate interrogation setting.

Method for spectrophotometric blood oxygenation monitoring

A method and apparatus for non-invasively determining a blood oxygen saturation level within an organ of a subject using direct application of a near infrared spectrophotometric sensor is provided. The method includes the steps of: a) transmitting a light signal directly into the subject's organ using the sensor; b) sensing a first intensity of the light signal and a second intensity of the light signal, after the light signal travels a predetermined distance through the organ of the subject; c) determining an attenuation of the light signal along multiple different wavelengths using the sensed first intensity and sensed second intensity; d) determining a difference in attenuation of the light signal between wavelengths; and e) determining the blood oxygen saturation level within the subject's organ using the difference in attenuation between wavelengths.

According to an aspect of the present invention, a near infrared spectroscopy (NIRS) sensor assembly, system, and method for measuring a characteristic of a biological tissue is provided. The NIRS sensor assembly includes a light source, at least one light detector, and a subject contact layer. The light source is operable to emit light at one or more predetermined wavelengths. The light detector has an active area for detecting light emitted by the light source and passed through the biological tissue. The detector is operable to produce signals representative of the detected light. The subject contact layer is disposed to cover one or both of the light detector and the light source. The subject contact layer has at least one optically transmissive portion.

Method for spectrophotometrically determining a blood oxygen parameter

According to the present invention, a method and apparatus for non-invasively determining the blood oxygen saturation level within a subject's tissue is provided. The method comprises the steps of: a) providing a spectrophotometric sensor operable to transmit light into the subject's tissue, and to sense the light; b) detecting light after passage through the subject's tissue using the sensor, and producing initial signal data from the light sensed; c) calibrating the sensor to that particular subject using the initial signal data, thereby accounting for the specific physical characteristics of the particular subject's tissue being sensed; and d) using the calibrated sensor to determine the blood oxygen parameter value within the subject's tissue.

A method and apparatus for monitoring a blood oxygen saturation level within a subject's tissue is provided. The method includes the steps of: a) sensing the subject's tissue using a near infrared spectrophotometric oximeter, and producing a value representative of the oxygen saturation level within the sensed tissue; b) comparing the determined saturation value to a predetermined threshold oxygen saturation value; and c) determining at least one of a time under threshold (TUT) value or an area under threshold (AUT) value using the determined saturation value and the threshold value.

Method and apparatus for monitoring a blood oxygen saturation level relative to a saturation threshold value

A NIRS sensor assembly includes a light source, a light detector, a first insulating layer, an EMI shielding layer, and a second insulating layer. The first insulating layer covers an exposed portion of the light detector. An optically transparent portion of the first insulating layer is aligned with an active area of the light detector. The EMI shielding layer covers the first insulating layer. An optically transparent portion of the EMI shielding layer is aligned with the active area of the light detector. The second insulating layer covers the EMI shielding layer and the first insulating layer. An optically transparent portion of the second insulating layer is aligned with the active area of the at least one light detector.

NIRS sensor assembly including EMI shielding

A method and apparatus for non-invasively determining a blood oxygen saturation level and/or the presence of fecal matter within a subject's lower GI tissue is provided. The method includes the steps of: a) providing a spectrophotometric sensor operable to transmit light into the subject's tissue, and to sense the light; b) sensing the subject's lower GI Tissue Using the Sensor, and Producing signal data from sensing the subject's tissue; c) processing the signal data, including determining the presence of one or more wavelength dependent light absorbing materials not present within blood within the subject's lower GI tract from the signal data; and d) determining the blood oxygen saturation level and/or presence of fecal matter within the subject's lower GI tissue, including accounting for the presence of the wavelength dependent light absorbing material not present within blood within the subject's lower GI tract determined using the signal data.

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Acton, MA, United States of America

Paul B Benni