Thomas M Blank

US Patent:

6415167, Jul 2, 2002

Filed:

May 2, 2000

Appl. No.:

09/563782

Inventors:

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.

US Patent:

6442408, Aug 27, 2002

Filed:

Sep 25, 2000

Appl. No.:

09/669781

Inventors:

Brian J. Wenzel - Cave Creek AZ
Stephen L. Monfre - Gilbert AZ
Timothy L. Ruchti - Gilbert AZ
Ken Meissner - Gilbert AZ
Frank Grochocki - Chandler AZ
Thomas Blank - Chandler AZ
Jessica Rennert - Scottsdale AZ

Assignee:

Instrumentation Metrics, Inc. - Chandler AZ

International Classification:

A61B 500

US Classification:

600310, 600473, 2503391, 2503418

Abstract:

An apparatus and method for non-invasively quantifying the hydration of the stratum corneum 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 NIR absorption 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, a calibration model developed from an exemplary set of measurements is applied to predict the SC hydration for the sample. The method of SC 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. The stratum corneum hydration measurement is therefore suitable for further spectral analysis and the quantification of biological and chemical compounds, such as blood analytes.

US Patent:

6475800, Nov 5, 2002

Filed:

Feb 10, 2000

Appl. No.:

09/502877

Inventors:

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).

US Patent:

6487429, Nov 26, 2002

Filed:

Jan 18, 2001

Appl. No.:

09/766872

Inventors:

Linda Hockersmith - Scottsdale 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:

600316

Abstract:

A method of calibrating a non-invasive blood glucose measurement instrument to a diabetic test subject employs targeted glycemic profiles in anti-correlated pairs. During calibration, reference blood glucose determinations are made using conventional invasive sampling methods. Concurrently, noninvasive spectral measurements are made using the noninvasive glucose monitor. Through controlled oral ingestion by the subject of calculated amounts of carbohydrate, the subjects blood glucose level is manipulated to mimic the patterns of the targeted profiles. During a first visit, a first profile of a pair is induced; during a second visit the inverse of the first profile is induced. The targeted profiles produce reference blood glucose values in which correlation to sampling factors is reduced or eliminated, thus the resulting calibration is correlated to glucose, and not to other analytes, sampling factors or environmental factors. A formula is provided for calculating the required amount of carbohydrate to ingest to induce a targeted glycemic profile in a test subject.

US Patent:

6512936, Jan 28, 2003

Filed:

Sep 18, 2000

Appl. No.:

09/665201

Inventors:

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.

US Patent:

6512937, Jan 28, 2003

Filed:

Apr 3, 2001

Appl. No.:

09/825687

Inventors:

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.

US Patent:

6640117, Oct 28, 2003

Filed:

Sep 17, 2001

Appl. No.:

09/955531

Inventors:

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.

US Patent:

6668181, Dec 23, 2003

Filed:

May 31, 2002

Appl. No.:

10/161197

Inventors:

Brian J. Wenzel - Cave Creek AZ
Stephen L. Monfre - Gilbert AZ
Timothy L. Ruchti - Gilbert AZ
Ken Meissner - Gilbert AZ
Frank Grochocki - Chandler AZ
Thomas Blank - Chandler AZ
Jessica Rennert - Scottsdale AZ

Assignee:

Sensys Medical, Inc. - Chandler AZ

International Classification:

A61B 500

US Classification:

600310, 600473, 2503391, 2503418

Abstract:

An apparatus and method for non-invasively quantifying the hydration of the stratum corneum 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 NIR absorption 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, a calibration model developed from an exemplary set of measurements is applied to predict the SC hydration for the sample. The method of SC 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. The stratum corneum hydration measurement is therefore suitable for further spectral analysis and the quantification of biological and chemical compounds, such as blood analytes.