WO2006093816B1 - Noninvasive targeting system method and apparatus - Google Patents

Noninvasive targeting system method and apparatus

Info

Publication number
WO2006093816B1
WO2006093816B1 PCT/US2006/006496 US2006006496W WO2006093816B1 WO 2006093816 B1 WO2006093816 B1 WO 2006093816B1 US 2006006496 W US2006006496 W US 2006006496W WO 2006093816 B1 WO2006093816 B1 WO 2006093816B1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
signal
measuring system
sample
targeting
Prior art date
Application number
PCT/US2006/006496
Other languages
French (fr)
Other versions
WO2006093816A3 (en
WO2006093816A2 (en
Inventor
Stephen L Monfre
Thomas B Blank
Kevin H Hazen
Alan Abul-Haj
Timothy L Ruchti
James Ryan Henderson
Tim Stippick
Roxanne Abul-Haj
Original Assignee
Sensys Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/117,104 external-priority patent/US7519406B2/en
Application filed by Sensys Medical Inc filed Critical Sensys Medical Inc
Priority to JP2007557171A priority Critical patent/JP2008531133A/en
Priority to EP06721018A priority patent/EP1850736A4/en
Publication of WO2006093816A2 publication Critical patent/WO2006093816A2/en
Publication of WO2006093816A3 publication Critical patent/WO2006093816A3/en
Publication of WO2006093816B1 publication Critical patent/WO2006093816B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A61B2562/0242—Special features of optical sensors or probes classified in A61B5/00 for varying or adjusting the optical path length in the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/14—Coupling media or elements to improve sensor contact with skin or tissue
    • A61B2562/146—Coupling media or elements to improve sensor contact with skin or tissue for optical coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems

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.

Claims

AMENDED CLAIMS received by the International Bureau on 07 November 2006 (07.11.2006)
1. An apparatus for noninvasive determination of an analyte property of a skin tissue, comprising: a targeting system used to reproducibly register a tissue marker representative of a location of the skin tissue, wherein said targeting system generates a first signal; a measuring system used to reproducibly sample a volume of the skin tissue, wherein said measuring system generates a second signal optically representative of the tissue; a controller, wherein said first signal from said targeting system is used by said controller during positioning of said measuring system relative to the skin tissue; and a data processing module, wherein said module generates said analyte property using said second signal, wherein repeated use of said targeting system to reproducibly register a tissue marker representative of the skin tissue and repeated use of said measuring system to reproducibly sample results in a narrow range of sampled tissue volumes, wherein said narrow range of sample tissue volumes results in enhanced accuracy of said analyte property as state of the skin tissue changes.
2. The apparatus of Claim 1 , wherein said targeting system and said measuring system commonly use at least one optic.
3. The apparatus of Claim 1 , wherein said targeting system comprises a functional first set of optics, wherein said measuring system comprises a second set of functional optics, and wherein none of said first set of optics is in common with said second set of optics.
53
4. The apparatus of Claim 1 , wherein at least a portion of said targeting system comprises a physical location within a housing containing at least a portion of said measuring system.
5. The apparatus of Claim 1 , wherein said targeting system further comprises a first housing, wherein said measuring system further comprises a second housing, and wherein said first housing is physically separated from said second housing.
6. An apparatus for noninvasive determination of an analyte property of a sample site of a tissue, comprising: an analyzer, comprising: a targeting system, wherein said targeting system generates a first signal; a measuring system, wherein said first signal is used in dynamically positioning said measuring system relative to the sample site; wherein said measuring system generates a second signal optically representative of the tissue; wherein repeated use of said targeting system reproducibly registers a tissue marker representative of said sample site and repeated use of said measuring system to reproducibly sample results in a narrow range of sampled tissue volumes about said sample site; and a data processing module used to generate said analyte property, wherein said narrow range of sampled tissue volume leads to enhanced accuracy of said generated analyte property as a function of time as state of the tissue changes.
54
7. The apparatus of Claim 6, wherein said first signal comprises a representation of a distance between said measuring system and the tissue sample.
8. The apparatus of Claim 6, wherein said first signal represents position of said targeting system relative to a non-tissue target, wherein said non- tissue target is imbedded within, positioned on, or attached to the tissue sample.
9. The apparatus of Claim 6, wherein said first signal comprises a representation of any of: a biological feature of the tissue sample; a chemical feature of the tissue sample; a physical feature; a natural component of the tissue sample a dermis thickness; a subcutaneous feature; a capillary bed; a blood vessel; arterial anastomoses; and stress/strain of the tissue.
10. The apparatus of Claim 6, further comprising a controller used during movement of any of: said measuring system; said targeting system; an actuator; and
55 the tissue sample.
11. The apparatus of Claim 6, wherein said measuring system comprises a base module in a first housing and a sample module in a second housing, wherein said first housing and said second housing are physically separated and communicatively linked.
12. The apparatus of Claim 6, wherein said measuring system further comprises: a first optic positioned in an optical train after said source; and a second optic in said optical train between said first optic and the sample, wherein said first optic removes a least one heat generating wavelength outside of a range of wavelengths used by said data processing module, and wherein position of said second optic is proximate the tissue sample.
13. The apparatus of Claim 6, wherein said targeting system further comprises a capacitance sensor used to generate said first signal.
14. The apparatus of Claim 13, wherein said first signal indicates any of: distance between a sample probe tip of said measuring system and the sample site of the tissue; and tilt of a sample probe of said measuring system relative to the sample site of the tissue.
15. The apparatus of Claim 6, wherein said measuring system comprises a near-infrared photon source, wherein said analyte property comprises a
56 glucose concentration, and wherein said targeting system comprises use of any of: ultraviolet light; visible light; and near-infrared light.
16. A method for noninvasively determining an analyte property of a sample site of a tissue, comprising: generating a targeting signal using a targeting system, wherein said targeting system comprises a portion of said analyzer; using said targeting signal in positioning a measuring system relative to the sample site, generating a noninvasive signal using said measuring system, wherein said noninvasive signal optically represents the tissue; processing said noninvasive signal to yield said analyte property; and repeating said steps of generating a target signal, positioning a measuring systems, generating a noninvasive signal, wherein said step of repeating results in a narrow range of sampled tissue volume about said sample site, wherein said narrow range of sampled tissue volume results in enhanced accuracy of said generated analyte property as a function of time as state of the tissue changes.
17. The method of Claim 16, further comprising the step of: dynamically generating said noninvasive signal during said step of positioning said measuring system.
18. The method of Claim 16, wherein said step of generating said noninvasive signal comprises spectral data collection during and/or after said step of positioning said measuring system.
19. The method of Claim 16, wherein said step of positioning said measuring system comprises movement of at least a portion of said measuring system in space through any of: an x-axis; a y-axis; a z-axis; rotation; and tilt, wherein said x-axis is defined along the length of a body part; said y- axis is defined across the body part; said z-axis is defined as orthogonal to the plane defined by the x- and y-axes; said tilt is an off z-axis alignment of longitudinal orientation a sample probe of the measuring system, wherein longitudinal orientation extends from a tip of said sample probe tip interfacing with a sample site to the opposite end of said sample probe.
20. The method of Claim 16, wherein said targeting system comprises use of any of: an acoustic signature; a digital mirror array; a digital light processor; a pulsed laser; a laser scanner; ultraviolet light; visible light;
58 near-infrared light; mid-infrared light; a Raman signal; and a fluorescence signal.
21. The method of Claim 16, wherein said targeting system comprises use of any of: impedence; and a capacitance sensor.
22. The method of Claim 16, wherein said step of generating said noninvasive signal comprises spectral data collection during a time period comprising proximate contact of said measuring system with the sample.
23. The method of Claim 16, further comprising the step of: using either said first signal or said second signal in determination of stress/strain of the tissue.
24. The method of Claim 16, wherein said targeting signal targets a depth of the tissue.
25. The method of Claim 16, wherein said measuring system comprises use of near-infrared light, said analyte property comprises a glucose concentration, and wherein said targeting system comprises use of any of: ultraviolet light; visible light; and near-infrared light.
59
PCT/US2006/006496 2005-02-25 2006-02-24 Noninvasive targeting system method and apparatus WO2006093816A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2007557171A JP2008531133A (en) 2005-02-25 2006-02-24 Non-invasive targeting system method and apparatus
EP06721018A EP1850736A4 (en) 2005-02-25 2006-02-24 Noninvasive targeting system method and apparatus

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US65672705P 2005-02-25 2005-02-25
US60/656,727 2005-02-25
US65870805P 2005-03-03 2005-03-03
US60/658,708 2005-03-03
US65882105P 2005-03-04 2005-03-04
US60/658,821 2005-03-04
US11/117,104 US7519406B2 (en) 2004-04-28 2005-04-27 Noninvasive analyzer sample probe interface method and apparatus
US11/117,104 2005-04-27
US76148606P 2006-01-23 2006-01-23
US60/761,486 2006-01-23
US11/361,143 US7697966B2 (en) 2002-03-08 2006-02-23 Noninvasive targeting system method and apparatus
US11/361,143 2006-02-23

Publications (3)

Publication Number Publication Date
WO2006093816A2 WO2006093816A2 (en) 2006-09-08
WO2006093816A3 WO2006093816A3 (en) 2006-11-09
WO2006093816B1 true WO2006093816B1 (en) 2006-12-28

Family

ID=36941660

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/006496 WO2006093816A2 (en) 2005-02-25 2006-02-24 Noninvasive targeting system method and apparatus

Country Status (4)

Country Link
US (1) US7697966B2 (en)
EP (1) EP1850736A4 (en)
JP (1) JP2008531133A (en)
WO (1) WO2006093816A2 (en)

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US20060200017A1 (en) 2006-09-07
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