Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/117—Identification of persons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
  • A61B5/0507—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  using microwaves or terahertz waves
• • 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
  • A61B5/145—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
  • A61B5/14546—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 analytes not otherwise provided for, e.g. ions, cytochromes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6825—Hand
  • A61B5/6826—Finger
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6838—Clamps or clips
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
  • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Definitions

• Systems and methods for non-invasively scanning and analyzing one ' or more characteristics of a sample utilizing electromagnetic radiation utilize an electromagnetic radiation source connected to a transmitter and an analyzer connected to a receiver.
• a sample to be analyzed is placed between the transmitter and receiver in a variety of different manners and a frequency sweep of electromagnetic radiation is transmitted through the sample to create a series of spectral data sets that are used to create one or more composite spectrograms, which are then analyzed to determine one or more characteristics of the sample.
• a magnetic field can alternatively be applied around the transmitter, receiver and sample to enhance some characteristic analysis applications. Samples include inert and living items, and the characteristics include a wide variety of different applications.
• Electromagnetic radiation has been used in a wide array of noninvasive diagnostic applications. X-rays have been used for many years to create a two dimensional image of the inside of an object. Computed axial tomography scanners are able to generate three dimensional images from a series of two dimensional x-ray images. Magnetic resonance imaging (also known as nuclear magnetic resonance spectroscopy), such as disclosed in Harms et al., US 5,415,163 A and Rapoport et al., US 4,875,486 A, operate by first applying a magnetic field to a subject so as to align, in a uniform manner, the nuclei of atoms within a portion of the subject to be tested.
• Magnetic resonance imaging also known as nuclear magnetic resonance spectroscopy
• RF radio frequency
• the magnetic field is then removed or altered, causing the nuclei forced to a resonant frequency to become unstable and return to their original lower energy state. This later process is called spin relaxation.
• the faint energy released from the spin relaxation is then collected as a representation of the nuclei within the sample.
• the spin relaxation energy released by the sample is used to generate an image that is representative of the sample.
• the RF signal itself is not utilized for detection or imaging purposes - it is only used to excite the nuclei to a higher energy state and is removed before the spin relaxation energy is detected. Further, the magnetic field(s) are only used to align and then release the nuclei in the sample, and are removed or altered before spin relaxation can occur.
• 4,765,179 used periodic electromagnetic waves between 1 MHz and 1 GHz, that were coupled to a subject's finger, to generate a waveform that provided meaningful analysis of glucose levels in the subject based on the presence of other compounds in the subject's blood at specific frequencies (i.e., 17.75 MHz for sodium chloride and potassium chloride, 11.5 MHz for ethyl alcohol, etc.).
• a probe is applied to the subject's skin, through which electric pulses from a pulse generator are fed and partially reflected back to a measuring device, where a time resolved measurement is made.
• the glucose level is determined from matching the measured voltage to a calibration table.
• the detected signal is then sent to an analyzer that employs pattern recognition techniques to compare the detected signal at a specific frequency (with respect to glucose, the '048 patent specified 2.48 GHz), to previously detected signals at the same frequency to make a determination regarding the characteristic of the sample being tested. For example, if the sample was a finger of a patient that had previously been tested when the patient was known to have different glucose levels (verified through a more traditional form of glucose testing) to create three or more previously detected signal patterns, the presently detected signal would be compared to each of these previously detected signal patterns to determine which pattern it most closely resembled in order to approximate the patient's present blood glucose level.
• a specific frequency with respect to glucose, the '048 patent specified 2.48 GHz
• a number of noninvasive detection technologies have been developed to address these needs, such as fingerprint scans, iris and retina scans, and voice recognition. These technologies operate on the principal that individuals possess unique and unchanging physical characteristics that can be measured and compared with stored data.
• the basic requirements for acceptable biometric technology are that it must allow for practical widespread use, be accurate and reliable, be difficult or impossible to circumvent, be quick, easy and convenient, present no or little privacy violation concerns, be low cost to produce, and be consumer friendly.
• Current biometric identification and authentication technologies do not meet all of these basic requirements.
• Iris and retina scanning technologies can be highly accurate, but the equipment used in scanning is expensive and requires substantial space. Further, humans are highly uncomfortable with the idea of having their eyes scanned with a laser or infrared light or having their picture taken and stored by a machine (and then used by who knows who). Also, iris and retina scanners have been spoofed with a number of techniques that have required the technologies to be modified in various ways, making the technology more expensive, less convenient, and less consumer friendly.
• Electronic or optical fingerprint scanning systems are inexpensive, but are not very accurate, are easily damaged, and can be easily spoofed. Variations in skin, ethnic races with very light fingerprint patterns, people with unusually dry skin, elderly people, people with rough hands, water webbing, abrasions and cuts have all been known to create difficulties for fingerprint systems. Furthermore, many people consider fingerprinting to be an invasion of their privacy because of the heavy use of fingerprinting for law enforcement purposes. Additionally, many fingerprint scanning devices have been easily spoofed with objects as common as gummy candy.
• Voice recognition systems tend to be the least accurate of the other biometric identification and authentication technologies. Voices can be readily recorded or mimicked, and allergies, colds and other respiratory issues can readily produce false negatives. Hand geometry and face recognition systems suffer from similar issues. They also tend to require a large amount of space and face recognition systems can be expensive. As with fingerprints, changes in a subject's skin, such as a suntan, a burn or a skin condition, or other changes to a subject's physical appearance can present problems for the system.
• Figure 1 is a block diagram illustrating the transmission, reception and analysis systems of an embodiment
• Figure 2 is a partially cut-away, perspective view with hidden lines of the sample scanning apparatus of an embodiment
• Figure 3 is a cross-sectional view of either a transmission node or a receiver node of an embodiment
• Figure 4A is a partially exploded, perspective view of an embodiment including one pair of nodes and two pairs of magnets;
• Figure 4B is a partially exploded, perspective view of an embodiment including two pairs of nodes and two pairs of magnets;
• Figure 4C is a perspective view of an embodiment of a scanning apparatus
• Figure 4D is a perspective view of the rear of the scanning apparatus of
• Figure 4E is a perspective view of an embodiment of a flow through sensor
• Figure 4F is a perspective view of an embodiment of the temperature control unit of the flow through sensor of Figure 4E;
• Figure 4G is a more detailed perspective view of an embodiment of a scanning apparatus for use in the flow through sensor of Figure 4E;
• Figure 4H is a more detailed perspective view of the flow through sensor of Figure 4E;
• Figure 5 is an illustration of a composite spectrogram display for glucose scanning in accordance with an embodiment
• Figure 6 is a block diagram illustrating a remote detection and analysis configuration in accordance with an embodiment
• Figure 7 is an illustration of a real-time composite spectrogram for biometric identification in accordance with an embodiment
• Figure 8 is an illustration of a stored spectrogram for comparison to the real-time spectrogram of Figure 7, and further illustrating the areas of difference and the regions of relevance between the two spectrograms;
• Figure 9 is an illustration of a filtering analysis in accordance with an embodiment
• FIG. 10 is an illustration of a personal identity determinator (PID) in accordance with an embodiment
• Figure 11 is a block diagram illustrating the master biometric identification algorithm and its sub-element algorithms
• Figure 12 is a flow chart representing an operating method for fine- tuning pattern recognition algorithms
• Figure 13 shows a flow chart representing a method for fine tuning pattern recognition algorithms for instances when a prior subject uses a new sensor
• Figure 14 is a representation of a ratio matrix of clusters for use in a quantification embodiment
• Figure 15 is a representation of a preliminary registration table for use in the quantification embodiment of Figure 14;
• Figure 16 is a flow chart representing the enrollment process of the
• Figure 17 is a representation of a table used for an embodiment of the
• Figure 18 is a flow chart representing the identification process of the
• Figure 19 is a representation of an embodiment of a biometric identification application.
• An embodiment is related to noninvasive systems and methods for scanning and analyzing one or more characteristics of a sample, including living and inert objects, utilizing electromagnetic radiation.
• an embodiment utilizes a large spectrum of electromagnetic radiation that is transmitted through a sample to a receiver that creates a series of spectral data sets that are then developed into a composite spectrogram by an analyzer and processed to determine the one or more characteristics of the sample.
• a magnetic field can alternatively be applied around the transmitter, receiver and sample to enhance some characteristic analysis applications and to make other characteristic analysis applications possible.
• the sample is usually a finger or some other part of the body that can be inserted into or placed on a scanning apparatus for scanning purposes. Solids, liquids and gasses can all be measured using the same basic scanning apparatus and different types of delivery and control systems.
• a characteristic can be the sample's possession of some substance, feature, level, percentage, sui generis identity, etc.
• a characteristic could also be a class, species, genre or category. In other words, a characteristic could be almost anything.
• the characteristics that can be tested or scanned for in humans and many other living samples include naturally occurring components of the blood, such as blood glucose levels, hemoglobin, cholesterol levels, proteins, red and white blood cell counts, lipids, C-reactive proteins, calcifications and hormone levels, as well as introduced components, such as steroids, pathogens, viruses, bacteria, yeasts and heavy metals, as well as many other biological markers, agents and substances, including biometric identifying markers and controlled substances such as illegal drugs, alcohol and poisons (all identified as "biometric markers” herein).
• meat and produce can be tested for characteristics indicating bacterial and other forms of contamination.
• food products can be tested to regulate mixtures or the quantity of ingredients present, as well as to detect the presence of foreign elements such as metal, blood, nuts, milk and other allergens.
• unknown substances can be tested to determine their identity, such as illegal drugs, prescription drugs, explosives, poisons and bacterial agents (e.g., anthrax, nerve agents, etc.).
• environmental substances can be scanned and identified in a wide variety of other applications, including biohazard and hazardous material situations, analysis of drinking water for pollutants, contaminants, minerals, and bacteria, and the analysis of air, water and ground (e.g., dirt, minerals, etc.) samples for similar substances.
• materials can be tested to regulate or control the mixtures of substances, such as plastic, synthetics and petroleum, and the exhaust or byproducts of manufacturing operations can be analyzed to alert an operator of various different conditions, such as a malfunction.
• Liquids can be identified for many different purposes, such as in airport security, stadium security or other security operations, or even authenticity, i.e., scanning a bottle of corked wine or sealed liquor to determine its identity, its condition or possibly even its age.
• substances and combinations of substances such as certain liquids, can be tested to confirm whether they are what they are claimed to be. For example, when an airport traveler claims a clear liquid to be water, the liquid can be tested to determine whether it is water, and if it is not, the liquid and/or the traveler could be held for further investigation.
• the authenticity of many other objects such as money, bonds, antiques, documents, etc., can also be verified.
• Figure 1 is a block diagram illustrating the transmission, reception and analysis systems of an embodiment.
• the CPU 10, I/O 12 and memory 14 can be configured as standalone components when utilized in some applications or incorporated into a larger computer system 16 for use in other applications.
• some scanning applications may require an embodiment to be contained within a small, handheld, battery- powered unit that performs a limited application and only requires minimal processing, memory and data handling capabilities (See Figure 6 for an example of such a device), while other applications may enable computer 16, incorporating the CPU 10, I/O 12 and memory 14, to be located away from the sample, thereby making many more applications possible.
• Either the CPU 10 or the computer 16 is further connected to a transmitter 18 and a receiver 20, either directly as shown in Figure 1 or through the I/O 12.
• the transmitter 18 is preferably capable of generating electromagnetic radiation across a broad spectrum. While many applications only require a frequency sweep between about 1 MHz to about 20 GHz, additional information about a sample and its characteristics can be achieved utilizing frequency sweeps in ranges from as low as about 9 kHz, or lower, and as high as about 810 THz, or higher.
• the type and arrangement of the nodes would also be impacted by the object being scanned.
• a more solid or opaque object might block the transmitted infrared signal from being detected by the receiver node.
• the transmission node it might be necessary to have the transmission node also operate as the receiver node, or to place the transmission node and the receiver node on the same side of the object, such that a deflected signal could be detected.
• a lower harmonic of the visible light signal could be utilized in place of the visible light signal.
• one or more transmission nodes 22 are connected to the transmitter 18 and used to transmit the electromagnetic radiation and one or more receiver nodes 24 are connected to the receiver to receive the electromagnetic radiation once it has been transmitted through or reflected by the sample, or reflected by the node itself.
• One embodiment of the invention provides antenna components that can be utilized for both the transmission node and receiver node, but at higher frequency levels, non-antenna transmit/receive components may be required.
• FIG. 2 provides a partially cut-away perspective view, with hidden lines, of a sample scanning apparatus 30 in conformity with an embodiment.
• the sample module and scanning module or apparatus illustrated in Figure 2 is designed for scanning applications where the sample to be tested, such as a finger of a human, or similarly shaped object such as a test tube or sample container, is placed inside the scanning apparatus 30.
• the base or bed 32 of the scanning apparatus is shaped in such a way that a finger or object placed within the scanning apparatus 30 will be held in a consistent position. Additional guides or stops can be arranged inside and outside the scanning apparatus to ensure constancy of placement of the sample.
• the back wall 34 of the scanning apparatus 30 acts as a stop for the finger or object placed inside.
• the bed 32 is comprised of a left arm 36 and a right arm 38 with an angled or rounded central guide wall 40 formed there between.
• the rounded shape of the guide wall 40 helps to further ensure consistent placement of an inserted finger or similarly rounded object.
• the bed 32 is formed from a material that has a low dielectric constant
• D k (as close to 1 as possible), such as a cross-linked polystyrene, like REXOLITE 1422 (a trademark of C-Lec Plastics Inc.). In such materials the change in D k is negligible with temperature fluctuations.
• REXOUTE is presently used, other materials could also be utilized and even some materials with higher dielectric constants or other properties not present in REXOLITE could enhance some applications.
• REXOUTE 1422 is a thermoset, rigid and translucent plastic with a dielectric constant of 2.53 (up to 500 GHZ) and an extremely low dissipation factor. The performance characteristics of the REXOUTE 1422 bed 32 enables the transmission node 22 and the receiver node 24 to be placed or embedded directly in the bed 32.
• the nodes 22 and 24 are spaced apart so as to enable a finger or object to be placed between the two nodes, such that any signal transmitted from the transmission node 22 would go through the finger or object to reach the receiver node 24.
• Highly shielded transmission lead 23 connects the transmission node 22 to the transmitter 18 and highly shielded receiver lead 25 connects the receiver node 24 to the receiver 20.
• the shape and arrangement of the nodes 22 and 24 are application specific. As illustrated in Figure 2, the arrangement of the nodes 22 and 24 and the other components of the scanning apparatus 30 are utilized for biometric testing, glucose level testing and similar types of applications. This same arrangement can be utilized to identify an unknown fluid contained within a test tube or sample container, but a different configuration of the sensor, as illustrated below, may be desirable for such applications.
• the transmission lead 23 and the receiver lead 25 presently utilize 50 ohm cables to carry power to the nodes.
• the reactive impedance from the nodes to the ground plane of the scanning apparatus 30 (not shown) through the base 32 has been minimized to about 50 ohms at 12 GHz.
• This impedance is determined by the capacitance of area and spacing of the nodes to the ground plane and the dielectric constant of the REXOLITE base 32. Since reactive impedance varies as I/frequency, at higher frequencies, very little power could be transmitted through such leads. Hence, at higher frequencies, very different equipment will be required to make the scanner operate effectively.
• the shape, orientation and material composition of the nodes can also improve the performance characteristics of the scanning apparatus 30.
• An embodiment of shape and material composition of either of the nodes 22 and 24 is further illustrated in Figure 3, which is a partially broken, cross-sectional view of either a transmission node or a receiver node.
• the node is comprised of a metal base 300, such as solid brass with gold plating, although other non-reactive or low reactive metals or alloys could be utilized for the plating.
• the antenna 302 for the node is inserted into the base 300 through an opening 304 formed in the base 300.
• the top 308 of the antenna 302 is prick punched and affixed with a silver epoxy, although many other manners of securing and connecting the antenna 302 could be utilized.
• a REXOLITE 1422 screw or post 310 is inserted into a second opening 312 formed in the base 300, which screw or post 310 is in turn affixed or secured to the base 32.
• nodes 22 and 24 are arranged and oriented within the bed 32 so as to enable the majority of most human index fingers to rest within the bed while making contact with both nodes 22 and 24.
• an object to be analyzed could be shaped or placed within a container, such as a specially shaped container formed from a material such as REXOLITE 1422 that would enable the object to rest within the bed 32 in contact (perhaps through the container) with both nodes 22 and 24.
• contact between the finger or object to be analyzed and both nodes 22 and 24 is not necessary to enable detection of an adequate signal at the receiver node 24, but in other applications such contact can make a significant signal quality difference.
• Figure 2 illustrates an embodiment with a single transmission node 22 and a single receiver node 24, which enable the creation of spectral data sets for analysis by the CPU 10, additional nodes can be utilized to create additional spectral data sets for additional analysis.
• additional nodes can be utilized to create additional spectral data sets for additional analysis.
• the nodes 22 and 24 can also be arranged in arrays of two or more nodes to create further spectral data sets for analysis.
• the terms "spectral data set” or “spectral data sets” refer to any spectra collected at a particular frequency or sample point, even if there is only a single spectrum at any such frequency or sample point.
• composite spectrogram refers to any collection of spectral data sets into a data file, regardless of whether that data file is then used to generate an image of the combined spectral data sets within the data file or is processed in its raw form by one or more algorithms to generate an output based on the combination of spectral data sets.
• the bed 32 (including the nodes 22 and 24) is enclosed within a closed-top housing 42 that provides structural stability for the scanning apparatus 30, provides a clear opening for insertion of the finger or object to be tested, and that provides electrical shielding.
• the housing 42 could also be open-top, either partially open around the area in which a finger or object to be tested would be placed, or completely open on the top.
• the housing 42 could be differently shaped as well, as further described below.
• a housing 42 composed of a shielding material and providing somewhat less than 360 degree coverage, as illustrated in Figure 2, would allow for simple insertion of the finger or object, would reduce electrical noise, and would reduce environmental interactions with any magnetic field generated within the housing, as further described below.
• the housing 42 would also include a base portion (not shown in Figure 2) below the bed 32, magnets 44 and 46, and blocks 48, 50 and 52, to complete the housing enclosure.
• the housing 42 could be formed of REXOUTE 1422 or other materials, such as aluminum or copper. Alternatively, if the housing is to be used to also provide magnetic shielding, the housing 42 could be made somewhat larger to provide a sufficient gap or spacing from the magnets 44 and 46; at least 0.3 inches, and be fabricated from soft iron, mu-metal (a nickel-iron alloy (from about 65% to 85% nickel, from about 5% to 25% iron, plus copper and molybdenum) that has a very high magnetic permeability) or other similar metal of sufficient thickness to prevent saturation of the metal. The housing 42 could also be fabricated to include RF shielding, such as an attunement shield that tunes in or out certain frequencies to deaden or enhance information in the composite spectrograms.
• RF shielding such as an attunement shield that tunes in or out certain frequencies to deaden or enhance information in the composite spectrograms.
• the scanning apparatus 30, as illustrated in Figure 2 also includes magnets 44 and 46 positioned on the outside of arms 36 and 38 that form a magnetic field around the nodes 22 and 24 and the object to be tested.
• the magnetic field created by the magnets 44 and 46 is completely irrelevant and the magnets should not be utilized.
• the magnetic field enhances the analysis of the composite spectrograms, but is not required.
• the magnetic field appears to be required to generate more usable spectral data sets.
• high-gauss permanent bar magnets made of a Neodymium compound (Nd 2 Fe I4 B), cylindrically shaped of dimensions of about 1.25 inches long by about 5/8 inches in diameter of 50 MGOe (Mega Gauss Oersted) are used, although other magnets of different compositions, shapes, and strengths and even nonpermanent magnets (created using electromagnetism) could be utilized.
• the shape, position, strength and number of magnets 44 and 46 utilized is important with respect to configuring the position of the magnetic field relative to the transmission node 22 and receiver node 24 and the sample to be tested, and the intensity of that magnetic field.
• Figure 2 illustrates an embodiment with magnets 44 and 46 positioned on the outsides of arms 36 and 38 and held in place on the sides of the magnets 44 and 46 by REXOLITE 1422 blocks, such as block 48 and blocks 50 and 52 illustrated with hidden lines.
• a block corresponding to block 48 would be positioned next to magnet 46, but is not visible in Figure 2 due to the presence of the housing 42.
• Figure 4A is a partially exploded, perspective view of an alternative embodiment of the scanning apparatus illustrated in Figure 2.
• the scanning apparatus 400 of Figure 4A is comprised of one set of nodes and two sets of magnets.
• a base 402 supports a finger guide 404, made of REXOUTE 1422 or a similar material, and a riser plate 406.
• the bed 408 also supports a stop 418, which operates in conjunction with the shape of the finger guide 404, the trough 410 of the bed 408, and the first node set 412 to position a finger, sample or object in the correct position and orientation within the scanning apparatus 400.
• a housing 420 fits over the top of the base 402 to complete the enclosure and to provide a magnetic field through the nodes and sample in addition to RF and/or magnetic shielding, when needed. Housing 420 also forms an opening 422 through which a finger, sample or object could be inserted.
• the housing 420 also supports two sets of magnets that are affixed to the opposite inner sides of the housing. Only magnet 424, of a first set of magnets, is illustrated in Figure 4A, affixed to the left inside wall 426 of the housing 420, with the south pole 428 of magnet 424 facing the inside of the scanning apparatus 400. Another magnet, with its north pole facing inward would be positioned on the right inside wall of the housing 420 opposite magnet 424.
• a second set of magnets would be similarly affixed to the inside walls of the rear of housing 420, facing in opposite directions and with their poles reversed in comparison to the first set, i.e., the magnet on the same side of the housing 420 as magnet 424 would have its north pole facing the inside of the scanning apparatus 400.
• Figure 4B is almost identical to Figure 4A, but includes a second node set comprised of a second transmission node 430 and a second receiver node 432.
• the base 402 is about 2.20 inches wide, about 3.20 inches deep, and about 0.10 inches thick.
• the housing 420 is about 1.67 inches tall at the front. All of the remaining parts of the scanning apparatus 400 are scaled accordingly.
• the scanning apparatus 30 of Figure 2 is similarly sized. Of course, other sizes and configurations are possible and might be preferred for different scanning operations. Accordingly, an embodiment anticipates many other possible sizes and configurations and is not limited by the sizes and configurations illustrated herein.
• Figure 4C illustrates another alternative embodiment of the scanning apparatus illustrated in Figure 2.
• the scanning apparatus 440 of Figure 4C has at least an upper portion that is cylindrically shaped.
• the base of the scanning apparatus may have a rectangular base, allowing the scanning apparatus to stand and be stable on a flat surface.
• the scanning apparatus consists of a cylindrical housing 441 to provide enclosure and to provide a magnetic field around the nodes and the sample in addition to RF and/or magnetic shielding, when needed. Housing 441 also forms a finger opening 442 in the front and a second opening (not shown) in the rear of the apparatus.
• the housing 441 and the base (not shown) of the scanning apparatus 440 are held firmly in place by a first face plate 443 and a second face plate 452 on the opposite end (shown in Figure 4D).
• the first face plate 443 and the second face plate 452 can be attached to the housing 441 and the base with one or more screws, by welding, or other suitable methods well known in the art.
• the first face plate 443 can be part of the magnetic shield contained in the housing 441.
• the first face plate 443 and the second face plate 452 may have rectangular bottoms, further allowing the scanning apparatus 440 to stand firmly.
• a finger guide 444 is attached to the first face plate 443.
• the finger guide 444 can be made of a material with a low dielectric constant, such as REXOLITE 1422.
• a base or bed 445 of the scanning apparatus is shaped in such a way that a finger or object placed within the scanning apparatus will be held in a consistent position. Additional guides or stops can be arranged inside and outside the scanning apparatus to ensure constancy of placement of the sample.
• the scanning apparatus 440 of Figure 4C employs dipole antennas.
• the center conductor of the semi-rigid coaxial RF connector 448 is connected (via soldering or similar means) to the back half of the dipole electrode 446, while the metal shield of the coaxial RF connector 448 is connected to the front half of dipole electrode 446.
• the center conductor of coaxial RF connector 449 is connected to the front half of the dipole electrode 447 and the metal shield of the coaxial RF connector 449 is connected to the rear half of the dipole electrode 447.
• the coaxial RF connectors 448 and 449 are then routed within the scanning apparatus 440 to the rear of the unit.
• a first set of magnets 450 are placed below and along the length of the base 445.
• a second set of magnets (not shown) are placed on the inside of the top of the housing 441, directly opposite the first set of magnets 450.
• the first set of magnets 450 consists of three magnets, with the north pole of the magnets facing up.
• the second set of magnets is aligned with the corresponding first set of magnets 450, with the south pole of the second set of magnets facing down.
• the first set of magnets 450 can also have the south pole of the magnets facing up, with the second set of magnets having the north pole of the magnets facing down.
• a different number of magnets can be used to obtain various behavior performances of the scanning apparatus 440.
• the first set of magnets would cover the entire base 445.
• the first set of magnets would cover only a fraction of the base 445.
• the shape of the magnets can also be varied.
• the magnets used can be round shaped, oval shaped, or pellet shaped.
• the first dipole antenna 446 and the second dipole antenna 447 are in direct contact with the sample placed within the scanning apparatus 440.
• the dipole antennas 446 and 447 may be shielded in some manner from the sample placed within the scanning apparatus 440, to prevent the dipole antennas from coming in direct contact with the finger or object.
• the dipole antennas 446 and 447 may be placed further up on the side walls of the scanning apparatus 440, , instead of being placed in closer proximity to the bed 445 or next to the bed 445.
• the dipole antennas 446 and 447 may also be shielded with a material with a low dielectric constant, such as REXOLITE 1422.
• Figure 4D shows the back of the scanning apparatus 440.
• the second opening 451 allows for a tube to be passed through the scanning apparatus 440 when in use with the flow through sensor, further discussed herein.
• the scanning apparatus 440 without the second opening 451 can be used if testing samples without the need for the flow through sensor.
• a second face plate 452 is attached to the scanning device.
• One or more screws 453 can be used to anchor the base 445 and to keep the base 445 from moving.
• the screws 453 can be made of plastic or from a material with a low dielectric constant.
• a finger stop 454 allows for a finger or object to be inserted through the first opening 442 up to the point where the finger comes in contact with finger stop 454 on the inside of the scanning apparatus 440.
• the finger stop 454 is substantially T-shaped; however, any other shape that serves as a stopper indicator can be used to provide consistent positioning within the scanning apparatus 440.
• the finger stop 454 can be a removable piece, allowing for use of the scanning apparatus 440 with the flow through sensor described below.
• the finger stop 454, while described as a stop guide for fingers, also serves the same purpose with other objects. For example, if a liquid sample was being tested, the liquid sample could be placed in a test tube, with the finger stop 454 used for informing users how far to insert the test tube into the scanning apparatus 440. In an embodiment, the finger stop 454 could move along a horizontal axis, allowing for the finger stop 454 to be moved further inside of the scanning apparatus 440. This would allow for the finger stop 454 to be adjusted based on the size of the sample being inserted into the scanning apparatus 440.
• the finger stop 440 can be circular shaped and completely shield the second opening 451.
• This finger stop 454 could also be a removable piece.
• the finger stop 454 can also have a rectangular shape, or any other shape which completely shields the second opening 451.
• a set of RF connections 455 connect the dipole antennas with the transmitter 18 and receiver 20.
• the dipole antennas can transmit and receive data.
• a first RF connection 456 can connect the first dipole antenna 446 with the transmitter 18 and a second RF connection 457 can connect the second dipole antenna 447 with the receiver 20.
• a commercially available network analyzer could be used to perform the functions of the transmitter 18 and receiver 20.
• Two sets of semi-rigid coaxial cables (not shown) within the sensor apparatus 440 connect the first dipole antenna 446 and the second dipole antenna 447 with the RF connections 457, respectively.
• Figures 4E to 4H illustrate an embodiment of the flow through sensor
• the flow through sensor 460 consists of a mixing tank 461, including a screw cap 462.
• the test fluid that is being analyzed or identified is added to the mixing tank 461 by removing the screw cap 462 and pouring the liquid into the mixing tank 461.
• the test fluid added to the mixing tank 461 then circulates via a tube 463 (shown in Figure 4E, but identified in Figure 4H) into a pump 464 (shown in Figure 4H).
• the pump 464 pumps the test fluid out through the tube 465 into the temperature control unit 466.
• the temperature control unit 466 may be opened with a lid 467.
• the temperature control unit 466 can cool or heat the flowing test fluid to a set target temperature specified by a computer controlled controller 468.
• the controller 468 interfaces with a computer via a wired or a wireless connection to allow the temperature control unit 466 to be managed via program control.
• the test fluid circulates out of the temperature control unit 466 through tube 469 into a Pyrex tube (shown, but not separately identified in Figure 4E and 4G) with the Pyrex tube carrying the test fluid through the scanning apparatus 470.
• a Pyrex tube shown, but not separately identified in Figure 4E and 4G
• Any other material alternative to Pyrex which does not interfere with the signals being sent from the transmitter nodes to the receiver nodes can also be utilized, such as REXOLITE 1422 or some similar substance.
• One or more clamps 471 and 472 can be used to secure the Pyrex tube to the tube 469 carrying the incoming test fluid and the tube 473 carrying the outgoing test fluid. Additional clamps (some shown, but not separately identified in Figures 4E and 4G, and some not visible behind the scanning apparatus 470) serve to secure the Pyrex tube relative to the scanning apparatus 470.
• the test fluid passes through the scanning apparatus 470 and circulates through the tube 473 back into the mixing tank 461.
• Measured solute additions can also be added to the liquid in the mixing tank 461 by removing the screw cap 462 in order to calibrate the flow through sensor over a range of solute concentrations. Stirring and dissolving of the solute in the liquid occurs naturally due to the pumping and flowing action and complete dissolution of the solute additions can easily be detected over time by comparison of successive scans taken a few minutes apart. Complete dissolution becomes evident when successive scans become essentially identical.
• the scanning apparatus 470 connects to the transmitter 18 and receiver 20 through the connections 474.
• the test fluid in the mixing tank 461 may be flushed via a tube 475.
• the length of the Pyrex tube depends on the corresponding size of the scanning apparatus 470. It is important for the Pyrex tube to traverse the entire length of the scanning apparatus 470.
• the width of the Pyrex tube can be varied depending on the test fluid used or based on alternative settings and the size of the openings in the scanning apparatus for receiving the Pyrex tube. For example, using a smaller Pyrex tube and smaller tubing for the flow through sensor 460 requires the use of less test fluid. For example, if the test fluid was a blood sample, smaller overall tubing and a small Pyrex tube would probably be necessary in order to minimize the amount of test fluid needed to be added to the flow through sensor 460.
• split clamps serve to immobilize the Pyrex tube within the scanning apparatus 470 and to allow for certain constant conditions within the scanning apparatus 470 associated with movement of the Pyrex tube while the sample is being scanned.
• Other variations including temperature, humidity, and pressure differences are removed through use of the temperature control unit 466 and the closed loop system, which enable constant conditions.
• Positioning and repositioning errors and applied pressure (such as pressure applied to the Pyrex tube during a scan) errors are nonexistent.
• the flow through sensor 460 removes these variables, only allowing for the variation of the test fluid and desired temperature variations.
• a dielectric can be placed between the Pyrex tube and the dipole antennas within the scanning apparatus 470.
• Stainless steel tubing 476 contained within the temperature control unit 466 circulates the fluid allowing for accurate temperature control of the fluid.
• the tube 465 connects to one end 477 of the stainless steel tubing 476 and a second end 478 of the stainless steel tubing 476 connects to the outgoing tube 469. This allows for the test fluid to have a constant and precise temperature as it flows through the scanning apparatus 470, thus removing errors due to fluctuations in temperature.
• the data collected from the flow through sensor 460 is highly accurate and stable, with low standard deviations in the generated data, due to the controlled environment and the temperature control. In an embodiment, the flow through sensor 460 can be used, with or without the temperature control unit 466, for quality control in industrial settings.
• fluids or chemicals produced in an industrial setting can be bled off from other equipment, pipes, tubing, etc., to check for quality or in order to identity foreign matter or chemicals by running fluids or chemicals through the flow through sensor 460.
• the flow through sensor 460 can be scaled accordingly in order to accommodate for a higher throughput.
• the speed of the flowing fluid running through the flow through sensor can also be varied by adjusting the pump or pumps 464 and the size of the tubing.
• the flow through sensor 460 can also be used for testing blood samples, urine samples, and other bodily fluids.
• the size of the tubing used in the flow through sensor 460, as well as the Pyrex or other tube inserted into the scanning apparatus 470 can be adjusted to accommodate for smaller quantities of fluid, such as blood samples.
• the data collected from blood samples flowing through the scanning apparatus 470 can be analyzed by one or more algorithms that detect various chemicals or substances in the blood samples, as further discussed herein.
• the flow through sensor 460 can detect properties of samples by analyzing the spectra data sets produced by the scanning apparatus. This is in contrast to bodily fluid tests which detect certain properties or chemicals in bodily fluids by applying foreign chemicals or catalysts and looking for a color change, or some other quantifiable change.
• the flow through sensor 460 can detect properties of the bodily fluids without applying any foreign chemicals or catalysts to the sample.
• scanning apparatuses 30 and 440 are particularly well suited for glucose and blood scanning applications in situ, a smaller-sized device might be more desirable for biometric identification.
• a direct sample scanning application (where the sample is appropriate to place directly into the scanning apparatus), or where the sample can be placed inside a container that can then be placed inside the scanning apparatus, it is preferable to place the finger, sample or container in direct contact with the transmission node and the receiver node.
• Such direct contact helps to improve or enhance the quality of the signal received by the receiver node after passing through the sample, such as through reduction in the amount of other signals (noise) that can be picked up by the receiver node at the same time and the amount of power loss (reduction in amplitude) in the received signal.
• a series of electromagnetic radiation signals covering a range or sweep of frequencies is transmitted from the transmission node(s) to the sample and to the receiver node(s).
• the amplitude of these signals can be the same or varied as different applications may require.
• This series of signals may be comprised of short signal bursts at each of a large number of distinct frequencies ("sample points") with small or large intervals between each frequency selected.
• sample points a large number of distinct frequencies
• spectral data is only needed at those specific frequencies to analyze appropriate characteristics of the sample.
• a frequency sweep between about 100 MHz and about 3 GHz is generally used, but frequency sweeps from about 10 MHz to about 2.7 GHz and about 0.3 MHz to about 20.1 GHz have also been used successfully.
• a sweep of about 0.3 MHz to about 20.1 GHz is used due to economics and physical configurations.
• higher frequencies can be used, where utilizing higher frequencies requires a different physical configuration of the scanning apparatuses and requires significantly more computational power to process the resulting spectral data sets and composite spectrograms.
• the transmitter 18 could be a commercially available signal generator, such as the Agilent Technologies' Agilent E8257D PSG Analog Signal Generator, which is capable (when properly accessorized) of synthesizing signals with high output power (at least 20 milliwatts, based on a constant peak to peak RF voltage of one volt and impedance of 50 ohm) and low phase noise in ranges between about 250 kHz and about 325 GHz.
• the receiver 20 could be a commercially available spectrum analyzer, such as the Agilent Technologies' Agilent ESA E4407B Spectrum Analyzer, which is capable (when properly accessorized) of receiving and analyzing signals in ranges between about 9 kHz and about 325 GHz.
• a singular network analyzer could be utilized to both generate and receive the necessary signals. More specialized equipment may be required to transmit and receive signals at lower or higher frequencies. Likewise, specific electronic circuitry capable of performing the same types of functions, in place of the signal generator and spectrum analyzer, could be developed for use in an embodiment. [0092] Spectrum generators, analyzers and similar electronic circuitry are commonly used to generate signals and to examine the resulting waveforms. Many such devices allow the user to select the number of sampling points at which signals will be transmitted within a particular frequency range, thereby determining the selected frequencies as well as the intervals between those frequencies.
• sampling points could be selected (based on the capabilities of the equipment noted above and the compute time required to process that many sample points), although a different number of points could readily be utilized with the same or different equipment and greater computational power.
• circuitry as noted above, it would be possible to specify the exact frequencies for each sampling point, which might give a user even further flexibility in terms of scanning a sample at the frequencies most likely to generate the most useful information.
• the presence of the sample, and in particular the composition of the sample at the particular moments during scanning, modifies the amplitude of at least some of the signals transmitted through or reflected by the sample from the transmission node(s) to the receiver node(s).
• the amplitudes of the signals are modified at different frequencies. In many cases, the amplitude is reduced, but in some cases, the amplitude is actually increased. It is possible that amplitude modification might result when electron spins are excited by the electromagnetic radiation, as well as the presence of a magnetic field, when utilized.
• electron spin resonance is only believed to occur when a molecule has an unpaired electron, such as a free radical in an organic molecule or a transition metal ion in inorganic complexes, and since most stable molecules have a closed-shell configuration without a suitable unpaired electron, electron spin resonance or similarly electron paramagnetic resonance cannot be the only basis for amplitude modification. Additional amplitude modification could therefore result from proton spins of radiated atomic nuclei, or other phenomena.
• rotational spectroscopy is believed to only really be practical when molecules are in the gas phase where the rotational motion is quantized. In solids or liquids, the rotational motion is usually quenched due to collisions. Dielectric/dipole oscillation or rotation (dielectric spectroscopy or impedance spectroscopy) would also appear to be occurring to some degree, possibly coupled with one or more of the other phenomena noted above.
• the amplitude modifications have particular meaning with respect to certain characteristics of each sample that can be determined from careful analysis of the resulting spectral data sets (as described below). This point is particularly important with respect to distinguishing an embodiment from numerous prior art techniques in which a composite signal is employed, but usually only at one or two frequencies are examined, to determine the presence of an analyte. These prior techniques do not look at a composite spectrogram, which represents an amassed congeries of data collected at many different frequencies, in order to perceive subtle quantitative relationships within that composite spectrogram or between compared composite spectrograms.
• frequency sweeps could be further varied.
• a first signal could be transmitted from a first transmission node and only detected by a directly, physically corresponding first receiver node, and then a second signal could be transmitted from a second transmission node and only detected by a second receiver node that directly, physically corresponds to the second transmission node, etc.
• all transmission nodes are also capable of receiving, it is also possible to transmit from one node and receive on all of the nodes, including the transmission node.
• the first signal could be transmitted from the first transmission node, but only detected by the second receiver node, while the second signal is transmitted from the second transmission node, but only detected by the first receiver node, etc.
• Additional arrangements of nodes and magnets (if used), including arrays of nodes, could create countless additional variations, including the transmission from a first transmission node and near simultaneous detection by multiple different receiver nodes.
• the position and orientation of the sample could also be varied from test to test or within a single test.
• a sample could be placed in the scanning apparatus in a first position, then scanning would be performed, then the sample would be rotated by some number of degrees (45°, 60°, 90°, 180°, etc.), and scanning would be performed again. This would result in multiple composite spectrograms that could be used to improve performance or the reliability of identity scanning, etc.
• the position of the sample in the scanning apparatus could be further changed by varying the extent of insertion into the scanning apparatus for each test.
• a finger could be inserted at a first position, where maybe just the finger tip is in contact with a first set of nodes, and then inserted further to a second position, where the first knuckle is in contact with the first set of nodes, etc.
• position and orientation variations, as well as scanning variations could be used to increase the distinctive information that is collected regarding the subject. Additional samples, such as a second finger, could also be used to enhance scanning.
• Figure 5 illustrates a composite spectrogram signal that is used for glucose level testing in accordance with an embodiment.
• a change in the magnitude of an RF signal transmitted through a finger occurs at about 2.48 GHz and that this change in magnitude correlates to the concentration of glucose or blood sugar in the finger.
• the '048 patent relied upon basic pattern matching at the specified frequency with previous tests to make a determination about a current test and a subject's current glucose level.
• an embodiment utilizes realtime pattern recognition analysis to make determinations about the glucose levels of the subject represented by the composite signal.
• the pattern recognition analysis is based on additional information found at other frequencies in the composite signal (other than about 2.48 GHz), together with additional data about the subject to be tested.
• the scanning apparatus of an embodiment enables certain characteristic patterns to be detected that are common to subjects with high, normal and low glucose levels. Additional patterns also indicate when a subject is exerting excessive pressure on their finger or when their finger is not properly placed within the scanning apparatus. Still further patterns indicate when a subject has moved their finger during scanning or when a subject's finger is not oriented in the optimal position.
• the size of a subject's finger can result in significant variations in the composite signal, which variations can be diminished by accounting for the greater blood volume that exists in large fingers and the lesser blood volume that exists in small fingers, such as through measurement of the finger to be tested at a common point.
• the analysis of the composite spectrogram signal of an embodiment, performed by software or specialized hardware within the computer 16, takes advantage of real-time software pattern recognition analysis in order to perform accurate analysis of a just-in-time captured composite spectrogram signal.
• This method of analysis of the composite signal enables more complex determinations to be made about the information represented by the composite signal. More importantly, this method of analysis enables rapid determinations about a subject's glucose level.
• a scanning device incorporating this technology could be placed in homes, businesses and common areas of stores, much like current blood pressure testing devices, and enable anyone utilizing the device to obtain an accurate measure of their current glucose level.
• an athlete's performance could be optimized through use of such a device by carefully monitoring blood sugar levels to make sure the athlete had the optimum amount of fuel for energy in their body at a needed time.
• a user By coupling the blood scanning features of an embodiment to a computer equipped with additional weight management software, a user could track their weight gain or loss over a period of time, but without being relegated to making rough guesses about calories consumed, through food and drink, and utilized, through normal body functions and exercises performed. Performance management software could play a similar cooperative role.
• an embodiment could be coupled with a calorie counting type of diet, so as to prevent the user from straying from reality (i.e., "that donut was only 50 calories” or "I only had a half portion”).
• Certain safety features could also be incorporated if a user was consuming too few calories over a period of time or exercising too much, such as by disabling the scanning device and/or sending a message to a central office so as to enable a person to check on the user.
• the composite signal illustrated in Figure 5 which is generated from a large set of spectral data sets, is representative of the type of signal generated during a glucose level test.
• the graph of the composite spectrogram signal 500 in Figure 5 represents frequency, in Hertz (Hz), along the horizontal axis and differential amplitude, in decibels (dB) along the vertical axis.
• the power or magnitude of the resulting composite signal is represented in decibels.
• the term "differential amplitude” is used to refer to the normalized amplitude signals that are generated by performing a scan first without a sample, performing a scan with the sample to be tested, and then subtracting the amplitude versus frequency results of the first scan from the results of the second scan. As illustrated in Figures 5, 7 and 8, the zero differential point is shown by the "0" at the approximate midpoint of the vertical axis in each graph.
• a measure of the blood volume of the subject's finger which are used to determine the subject's glucose level from the composite signal 500.
• a rough determination of the blood volume of the subject's finger i.e., the size of the finger, at the point of measurement because smaller than normal and larger than normal fingers can skew the results if the resulting blood volume (less for small fingers and more for large fingers) is not taken into consideration.
• the cross-sectional area of the finger at the approximate point of contact with the nodes is determined.
• This determination can be made in any of a wide variety of fashions, such as measuring the subject's finger with a piece of measuring tape, matching the subject's finger to a model of known size, or even including an automated finger measuring device inside the scanning apparatus that applies a small cuff or similar band around the finger to determine its size prior to scanning. The effect of this measurement on the glucose level determination will be discussed more fully below.
• the dashed baseline 502 in Figure 5 represents a decibel level, at the approximate 2.5 GHz frequency, that highly correlates to normal glucose levels. While the baseline 502 cannot be reliably used as the sole basis for measuring glucose levels, in the absence of comparative pattern matching as disclosed in the '048 patent, it can be used in conjunction with four other components of the composite signal 500 to reliably determine glucose levels. When referring to each of these components below, a reference to a component being “high” or “low” is in comparison to a median point for that component, and a reference to a component being “positive” or moving "upward” or “negative”.or moving "downward” is relative to the scale position of "0" on the decibel vertical scale.
• Figure 5 including the peaks, valleys and other signal components, is affected by the shape and strength of the magnetic field, the transmitting and receiving nodes, and numerous other factors, as previously discussed.
• the exemplary composite signals illustrated in Figures 5, 7 and 8 were created using a scanning device similar to that illustrated in Figure 2. Changes in this device or the use of a differently configured device, such as illustrated in Figures 4A-4H, might cause the peaks, valleys and other signal components to shift up or down in frequency or cause other changes that would have to be accounted for in analyzing the resulting composite signal.
• the first pattern component is the lowest point 504 (or decibel level) of composite signal 500. This lowest point typically occurs, but does not always occur, at approximate 2.5 GHz.
• the glucose level of the subject is most likely normal.
• the glucose level of the subject is most likely high.
• the glucose level of the subject is most likely low.
• the further away the lowest point 504 is from the baseline, in the negative direction, the lower that glucose level is likely to be.
• the terms “most likely” and “likely” are utilized because as previously stated, the baseline 502 alone, or comparison of the lowest point 504 to the baseline 502, only provides a rough estimate of a subject's glucose level, but it cannot alone be reliably utilized to determine a subject's glucose level, which is where the other components come in to play.
• Sampling points 506A, 506B and 506C which are sampled at a low frequency (approx. 100 MHz), represent the sample variation pattern component. This component is important because a subject inserting their finger into the scanning apparatus may exert more or less pressure on their finger, or move their finger around, which can cause the composite signal 500 to fluctuate as well, thereby causing the other components to change in some way.
• sampling the composite signal 500 at each of the specified sampling points 506A, 506B and 506C it is possible to remove many of the variations caused by finger movement or variation. For example, if the slopes of the lines formed between the three sampling points 506 are high, then the magnitude of the lowest point 504 is adjusted upward toward 0 dB. If the slopes of the lines formed between the three sampling point 506A, 506 B and 506C are low, then the magnitude of the lowest point 504 is adjusted downward.
• the next pattern component is the trough 508 in the composite signal 500 formed by the lowest point 504.
• the trough component 508 can simply be a measure of the width of the trough at a point just above 0 dB, or the entire area of the trough can be calculated.
• width if the magnitude of the trough component 508 is high (or wider than the median), then the magnitude of lowest point 504 is adjusted downward.
• the magnitude of the trough component 508 is low (or narrower than the median)
• the magnitude of the lowest point 504 is adjusted upward toward 0 dB.
• Area is utilized in the same way, with a larger area being used to adjust the lowest point 504 downward, and a smaller area being used to adjust the lowest point 504 upward toward 0 dB.
• the last fine-tuning pattern component is a high frequency signal at a specified point 510 at the end of the trough 508.
• the fine-tuning component is used for just that, to fine-tune the accuracy of detecting the blood glucose level for about 80% of subjects.
• the fine-tuning component should not always be used because in the remaining 20% of cases, the use of the fine-tuning component could actually lower the accuracy of the measured blood glucose levels of those subjects.
• the magnitude of the specified point 510 is lower than the median, then the magnitude of the lowest point 504 is upward toward 0 dB.
• the magnitude of the lowest point 504 is moved downward.
• Composite spectrogram analysis utilizing different algorithms to detect quantitative relationships or to recognize patterns, similar in some ways to those techniques described above, could also be used to measure many other aspects of a subject's physical condition or composition, as well as many other characteristics of other types of samples.
• composite spectrogram analysis could be used to measure or detect the presence of cholesterol (HDL and LDL as well), red and white blood cells, proteins (including antigens for determining blood type), hormones, steroids, lipids, C-reactive proteins, bacteria, yeast, viruses, pathogens, heavy metals, calcifications, and other biological markers, agents or substances.
• a composite signal Once one or more components of a composite signal have been identified as corresponding to any substance that can be found in the blood, tissue or bone of a subject, the presence and levels of that substance can be detected and measured utilizing an embodiment, without invading the subject's body, without having to compare that subject's current results with prior results, and in near real-time due to the speed of the computer aided analysis.
• the size, construction and operation of the device may be less critical than when utilized in a remote location, such as at the scene of an accident, the side of the road, or at multiple access locations throughout a building.
• a remote location such as at the scene of an accident, the side of the road, or at multiple access locations throughout a building.
• the cost associated with installing bulky machinery at multiple different locations, or the impracticality of utilizing such machinery at a remote location, requires a different solution.
• Figure 6 illustrates a portable scanning device 600 that is capable of capturing raw data from a person or object to be tested at a remote location and wirelessly communicating that raw data to a central server 602.
• the raw data collected by device 600 could, in turn, be encoded utilizing digital rights management technology, or some similar type of encryption or data rights management technology, so as to further prevent a competitive device from being able to compatibly communicate with the central server 602.
• the server 602 would then process the raw data according to one or more proprietary analysis programs to produce a diagnostic result for the raw data and wirelessly communicate the diagnostic result back to the device 600.
• the portable device 600 could be very simple and include a few predetermined scanning operations (selected through operation of a physical or electronic button on a touch screen), such as an alcohol test, a methamphetamine test, and one or two other tests, that could be selected by a law enforcement official in the field prior to collecting and communicating the raw data.
• the portable device 600 could be combined with an Internet browser 604 so as to enable the user to operate Internet- enabled applications and to perform other functions.
• a personal query could be communicated from Internet browser 604 to central server 602 requesting the performance of one of a large number of different tests.
• the central server 602 would then communicate with the portable device 600 to request and collect the necessary raw data, which would be communicated back to the central server 602.
• the central server 602 After processing the raw data, the central server 602 would then communicate the diagnostic results, as well as other data, such as tabulated charts and histories, medical opinions, interpretations and other data, back to the browser 604 for the user.
• the portable device 600 could be configured to identify itself to the central server 602 for each test to be run or for each data package to be sent, so that the user of the portable device 600 could be charged accordingly, such as on a per test/per download basis, on account, etc. Other forms of identification and payment arrangements could also be possible depending on how much intelligence and how many user interface controls are built into the portable device 600.
• Figure 7 is a real-time spectrogram (R) 700 representing a person (P) who was scanned or tested in accordance with an embodiment.
• the vertical scale represents decibels and the horizontal scale represents frequency, only unlike Figure 5, in Figure 7 the frequency scale ranges from 10 MHz to 12 GHz.
• the composite spectrogram (signal) illustrated in Figure 7 includes a number of prominent peaks and valleys, the combined position and shape of which, after processing, may be unique to every person.
• Figure 8 is a stored spectrogram (S) 800 representing the same person
• an embodiment performs the following six comparisons to identify changes that may be of significance: ⁇ , ⁇ l, ⁇ 2, ⁇ , ⁇ l and ⁇ 2, where ⁇ represents a change in spectrograms of a single person versus herself/himself, where ⁇ represents a change in spectrograms of a single person versus a different person, where 0 represents a small change, where 1 represents an infrequent change, and where 2 represents no change.
• a horizontal relevancy line 850 has been added below the spectrogram 800.
• the relevancy line provides an indication of the relevancy of different portions of spectrogram 800 toward the positive or negative identification of a person scanned.
• the relevancy line 850 is comprised of three types of regions, forward slash regions 852, blank regions 854, and backward slash regions 856. Only three types of regions are shown in Figure 8 for purposes of simplifying the drawing, but as many regions as were necessary could be utilized.
• Forward slash regions 852 correspond to regions of lower relevance, meaning that there can be a bigger difference between the amplitude in decibels of a point (fi) at a particular frequency on R 700 within region 852 from the amplitude of a point (f 2 ) at that same frequency on S 800. For purposes of simplicity, this difference is referred to as ⁇ , which is the difference between fiand f 2 . Hence, the forward slash regions 852 would have a higher threshold level that ⁇ would have to exceed before a variation between R 700 and S 800 was considered to be meaningful. Blank regions 854 correspond to regions of high relevance and therefore have a low threshold level for ⁇ .
• Backward slash regions 856 correspond to regions of medium relevance and therefore have a threshold level for ⁇ between that of blank regions 854 and forward slash regions 852.
• a point 902 on line 900 would be expected to be below the threshold T and would therefore be assigned a low f( ⁇ ) value, in this case the arbitrarily assigned value of 0.01(x).
• a point 904 is assigned a much higher point on the line 900, i.e., further past the threshold T, it is assigned a much higher f( ⁇ ) value, in this case the arbitrarily assigned value of 3.6(x). Since the probability of R 700 belonging to the same person represented by S 800 goes down the further ⁇ is past the threshold T, the values f( ⁇ ) increase exponentially along the vertical line f( ⁇ ) so as to assign higher and higher values to higher ⁇ values.
• the f( ⁇ ) valuations for each test point on the spectrograms 700 and 800 can also be summed, with the result effectively being a filtered sum. If the filtered sum for R 700 versus S 800 exceeds a predefined number, then R 700 represents a different person than S 800, and if the filtered sum is below that predefined number, then R 700 and S 800 represent the same person.
• the predefined number itself is not significant because it depends entirely on the values assigned to f( ⁇ ), which can be arbitrary.
• the numbers for f( ⁇ ) in Figure 9 are for illustration purposes only and could be readily changed without departing from the teachings of an embodiment.
• Figure 10 is a PID graph 1000 of B, a baseline spectrogram, versus S 800, where B is the vertical axis 1002 and S is the horizontal axis 1004.
• the baseline spectrogram B could be formed in a number of different manners, such as forming B from the mean or median of all spectrograms of a large population of people.
• the points 1006 along B and S represent the sampling points on each spectrogram. While only a limited number of such points 1006 are represented in the PID graph 1000, the total number of points 1006 could be any number. For example, as noted above when discussing the number of sampling points used in a frequency range from about 100 MHz to about 12 GHz, a total of about 3,201 sampling points could be used for both B and S.
• a comparison is done between the value of a sampled point 1006 on the spectrogram B 700 and the value of the same sampled point 1006 on the spectrogram S 800. If the value of B for a first sample point is greater than the value of S for the same sample point by more than a threshold level (B»S), then the corresponding sampled point square 1008 is assigned a "0" value. If the value of B for a first sample point is greater than the value of S for the same sample point by less than a threshold level (B>S), then the corresponding sampled point square 1008 is assigned an "x" value.
• the corresponding sampled point square 1008 is assigned an "x" value. If the value of B for a first sample point is less than the value of S for the same sample point by more than a threshold level (B»S), then the corresponding sampled point square 1008 is assigned a "1" value.
• a pattern will emerge of O's, l's and x's that is unique to that PID graph 1000.
• the pattern of the B versus S PID graph 1000 can then be stored and compared to a real-time created PID graph corresponding to person P, using B versus R, to see how closely the two PID graphs match.
• These patterns could be compared using any of a number of well known pattern matching techniques. For example, the patterns can be compared row-wise or column-wise, with every exact match adding a point to a total score, with the total score determining the similarity between R and S. The closer the proximity between the patterns of O's, l's and x's on the two PID graph, the greater the likelihood that R and S correspond to the same person.
• an embodiment can be utilized to perform many different tasks or applications.
• the detection and analysis method to be used in each instance will vary according to the task. For example, scans for human blood components would typically use detection and analysis methods similar to those used to scan for blood sugar levels, but could also use one or more of the methods used for biometric identification, where a known stored signal is compared to a real-time signal. These same types of methods could be used for agricultural inspection, food processing operations, security applications, environmental testing, manufacturing operations and many other applications. Authenticity applications would also be possible, where a security marker is used to mark and subsequently identify a valuable object.
• Algorithm-J uses multiple and/or linear regression type calculations to determine, at a given frequency, or at various combinations of frequencies, an instantaneous correlation coefficient, R2 (R-Squared), between the known values of, for example blood glucose, and their corresponding "calculated function", such as the ratio of differential amplitudes at two or more different frequencies, or the sum of differential amplitudes at two or more different frequencies, and so on.
• R2 instantaneous correlation coefficient
• the procedure used to find "the best known functions" to calculate is that once you pick one to try and set-up the program to run through the raw data, the CPU 10 finds and reports the regions of value, if any. For example, calculations on data from a "Glucose Tolerance” test, returned 25,140 combinations of the frequency function being calculated that resulted in an R2 value of 0.40 or greater, with the peak R2 value being 0.92. Furthermore, 20 combinations of the frequency function being calculated resulted in an R2 value of 0.84 or greater. Using the latter top 20 frequency functions in a hypothetical ensemble to estimate (simulate) a subject's blood glucose reading, using an embodiment of a sensor driven by a program using Algorithm-J, provided an R2 value of 0.95.
• a Person A 1202 has their blood glucose analyzed by a first commercial analyzer, step 1204, and a second commercial analyzer, step 1206.
• Step 1208 computes the average of the readings from the first commercial analyzer 1204 and the second commercial analyzer 1206.
• the blood glucose of Person A 1202 is also analyzed using the scanning apparatus 1210, resulting in a spectral data scan, step 1212.
• Step 1214 uses a pattern recognition algorithm that works for Person A with the scanning apparatus 1210.
• the output of the pattern recognition algorithm is a non-invasive blood glucose reading, step 1216.
• the averaged readings of the commercial analyzers and the reading of the scanning apparatus are checked for agreement, step 1218.
• the user can be prompted to repeat the process by doing a second sweep with the scanning apparatus.
• the flowchart 1200 shows the use of two blood glucose analyzers, the blood glucose level could be checked by more than two blood glucose analyzers in order to improve the accuracy of the blood glucose measurement.
• FIG. 13 shows a flow chart 1300 of a fine tuning method for a pattern recognition algorithm, illustrating the optimization of a scanning apparatus to work with Person A.
• a counter variable Z is set to 1, step 1302, and then Person A undergoes a glucose tolerance run, step 1304.
• This consists of performing a set of N finger-stick readings with a first commercial blood glucose analyzer, step 1306, and a second commercial blood glucose analyzer, step 1308, and a corresponding set of N scans performed with the scanning apparatus, step 1310.
• the finger-stick readings and scans are done at five to ten minute intervals while Person A's blood glucose level rises from a fasting level to a high level and then back down to the fasting level.
• each first reading from the first commercial analyzer, step 1306, is averaged with the second reading from the second commercial analyzer, step 1308.
• the pattern recognition algorithm being tuned is used to identify underlying feature set elements Fl through Fk, where k is the total number of underlying feature set elements, step 1314. This results in a set of non-invasive blood glucose readings, step 1316.
• Step 1318 calculates the correlation coefficient R2 between the finger-stick readings and the non-invasive readings calculated from the pattern recognition algorithm. If it is the first time that the correlation coefficient has been computed, step 1320, then the process continues to perturb the pattern recognition algorithm in order to improve its performance, step 1322.
• the perturbation of the pattern recognition algorithm is done by perturbing the value of relationship of underlying feature set element Fx, where x is the x th element in the list of feature elements from one through k.
• the perturbation of the underlying feature set element Fx is done relative to all the other feature set element of the pattern recognition algorithm.
• step 1324 applies the pattern recognition algorithm to the data collected from step 1310, resulting in a new a set of non-invasive blood glucose readings 1316.
• the new set of non-invasive blood glucose readings are used to calculate the correlation coefficient R2 with respect to the finger-stick readings in order to determine whether the perturbation improved the performance of the pattern recognition algorithm, step 1326.
• step 1326 the value of R2 is checked in step 1326 in order to determine whether the correlation coefficient R2 has improved due to the perturbations introduced into the pattern recognition algorithm. If R2 has improved, then the new x feature set element relationship value is saved, step 1328, and the process continues to step 1322 for further perturbations. If the value of R2 did not improve with the introduced perturbations, then step 1330 checks to see whether each element from the underlying feature set elements has been perturbed. Step 1330 performs this check by determining whether the last underlying feature set element to be perturbed is the last element of the set.
• step 1332 restores the x th feature set element relationship value to its value prior to being perturbed, and the value of x is incremented in order to perturb the next element in the set, the perturbation being done in step 1322. If each element from the underlying feature set elements has been perturbed, then step 1334 checks whether R2 has maxed out. If R2 has not maxed out, then the algorithm is perturbed once again in step 1322. At this point, in an embodiment the perturbation in step 1322 restarts with the first element, element 1. In another embodiment, the perturbation in step 1322 restarts with a random element between 1 and k.
• step 1334 if R2 has maxed out, then the counter variable Z is checked to see whether its value is equal to 3. If the value of Z is not equal to 3, then the value of Z is incremented by one in step 1338, and the algorithm is perturbed in step 1322. If the value of Z is equal to 3, then the process stops.
• the pattern recognition algorithm that was fine tuned with flow chart 1300 can be used as the starting algorithm to be perturbed and optimized to work with the new scanning apparatus.
• Other alternative methods that can be used to fine-tune the performance of the pattern recognition algorithm include hill climbers and genetic algorithms.
• the fine-tuning and determination methods both utilize spectral data sets derived from scans of fingers.
• One problem when working with an individual is repeatability of finger placement in the scanning apparatus and finger pressure on the electrodes or guide pieces in the sensor. Small errors in finger placement of the same finger from time to time introduce errors in the corresponding spectral data set. Portions of the spectral data relating to an individual can be utilized in specific comparative calculations to determine possible finger placement error.
• the scanning apparatus announces or otherwise signals to the person, that the finger placement is excellent, or if there is a larger placement error, the person can be told that the placement is not as good as last time, or un-acceptable, or to please try again.
• the non-invasive blood glucose algorithm Only when the finger placement is found to be "excellent", does the non-invasive blood glucose algorithm begin scanning spectral data to measure the person's blood glucose level. Then, by accumulating and averaging the successive excellent scans over time, and comparing each new spectral data set to the accumulated average, the individual can be trained how to place their finger so as to reduce finger placement error going forward. Reduction of finger placement error will improve the accuracy of the non-invasive blood glucose measurement.
• An embodiment is directed to a method for analyzing spectral data sets.
• the scanning apparatuses disclosed herein are capable of measuring the real and imaginary components of transmitted RF signals and the real and imaginary components of reflected RF signals.
• the real components represent the purely resistive properties of the sample (and associated scanning apparatus parts) placed within the scanning apparatuses, while the imaginary component represents the capacitive and inductive properties of the sample (and associated scanning apparatus parts).
• the computer 16 can also work with the transmitter 18 and receiver 20 to measure phase and power, which are derived from the real and imaginary components (also called the "raw components") of the reflected and transmitted signals.
• phase and power which are derived from the real and imaginary components (also called the "raw components" of the reflected and transmitted signals.
• total log magnitude power can be derived as follows from the real and imaginary components (using log to the base 10):
• the transmitted RF signal is best understood as that portion of the transmitted signal that is received by the receiver node 24 after having passed through or around the sample (referred to herein as S21 - which refers to signals received at port 2 of the receiver 20 from port 1 of the transmitter 18), while the reflected signal (referred to herein as SIl - which refers to signals received at port 1 of the transmitter 18 from port 1 of the transmitter 18) is comprised of two portions, the portion that is reflected from the sample back into the transmitter node 22 and to the receiver 20, and the portion of the transmitted signal that is never actually transmitted by the transmission node 22 because of inefficiencies in the circuitry and is reflected into the receiver 20 from the transmission node 22.
• the embodiment first requires a known sample to be registered with the computer 16 based on a variety of known conditions, so an unknown sample can subsequently be analyzed to determine its unknown conditions.
• a human subject may place a finger within the scanning apparatus to have their unknown glucose level determined by the computer 16, but this first requires the same human to have the same finger tested by the scanning apparatus when the human's glucose levels are known, and preferably at different glucose levels.
• the human referred to as a patient herein
• the patient would then be required to drink a highly sweetened liquid (such as Glucola), which causes the patient's glucose level to rise.
• a highly sweetened liquid such as Glucola
• the patient's finger would be tested with a glucose meter and scanned by the sensor, and then as the patient's glucose level began to return to a more normal level, the patient's finger would be tested with the glucose meter and scanning apparatus to develop a complete set of different glucose levels (high, low and normal). Since the variance between different glucose meters can be significant, it may be desirable to test each patient with at least two different glucose meters and average the results, as illustrated in Figure 12.
• the transmitter 18 transmits a series of RF signals starting at a base frequency and stepping up numerous times to higher frequencies until reaching a maximum frequency.
• Numerous different frequency ranges can be utilized.
• An embodiment uses a frequency range between about 0.3 MHz and about 20.1 GHz.
• the number of steps taken within the frequency range can also vary significantly.
• An embodiment uses an equal number of about 16,000 sampling points over the frequency range, but significantly smaller sets of sampling points could be used, equally spaced through the frequency range, or specific frequencies could be selected for a specific type of test.
• the total transmitted power signal received by the receiver 20 at each of the 16,000 or so sampling points is then recorded and processed.
• the initial step of the process in this sampling embodiment involves taking the total transmitted power signal recorded for the first sample point and dividing it by the total transmitted power signal recorded for each of the remaining samples points (i.e., 2/1, 3/1, 4/1, 5/1, etc.), then taking the total transmitted power signal recorded for the second sample point and dividing it by the total transmitted power signal recorded for each of the remaining samples points (i.e., 3/2, 4/2, 5/2, 6/2, etc.), and repeating this process until reaching 16,000/15,999.
• each sample point could be the numerator and the remaining sample points the denominator (i.e., 1/2, 1/3, 1/4, 1/5, etc.), or sample points could be grouped in sets of sample points, which are averaged together and then divided by the next set of averaged sample points, etc.
• the key in each case is to develop a set of ratios that can be compared to other ratios for each scan performed by the sensor.
• the first cluster is divided into the second cluster, and then the first cluster is divided into the third cluster, etc., up until the first cluster is divided into cluster 3,200.
• This process then continues with the second cluster divided into the third cluster, the second cluster divided into the fourth cluster, etc. This is repeated until cluster 3199 is divided into cluster 3,200, to develop the complete set of desired ratios.
• the number of sample points included in a cluster could be a number other than five.
• clusters offer an advantage over individual sample points because the clusters are less sensitive to frequency shifts that can be introduced by the sample, variations in scanning apparatuses and other external factors.
• FIG. 14 illustrates a ratio matrix of the clusters from a total of twelve glucose levels scanned for a patient.
• a number of different glucose levels could have been used, such as fewer glucose levels, or a first minimum number of glucose levels when a number of registered patients in the database is below a first registration count, and a second minimum number of glucose levels when the number of registered patients is greater than or equal to the first registration count.
• the minimum number of glucose levels to be used varies with respect to the number of registered patients and other factors. For instance, the minimum number of glucose levels can be set according to an accuracy level associated with the determination of an unknown sample. If a minimum of six glucose levels is used, and this yields a determination accuracy below the desired accuracy, then the number of glucose levels should be increased accordingly.
• An embodiment of a correction factor application uses different measured scan parameters to compensate for changes to analytes other than glucose that occur in response to the patient drinking the sweetened liquid, and other variables such as the patient's temperature, the patient's hematocrit levels, the patient's blood pressure level, etc, which can be measured by means other than the commercial blood glucose analyzers 1204 and 1206 shown in Figure 12.
• phase and other scan parameter correlations can be established for the variables other than glucose, and their corresponding correlation coefficients used to identify frequencies to be avoided when establishing glucose concentration.
• multiple linear regression calculations can be used to identify frequencies to be avoided in the presence of multiple variables.
• Another correction factor embodiment measures a substance of interest using, say, power or impedance, at a scan frequency sensitive to the substance and one or more measurements of power or impedance at scan frequencies not sensitive to the substance, but sensitive to additional confounding substances known to be present in the patient or the sample.
• the changes in power or impedance due to the additional substances can be subtracted from the sensitive frequency measurements of the substance of interest.
• the remaining change in power or impedance gives a measure of concentration of the substance in the patient or sample.
• the next step in the L-21 algorithm process is to take each row of ratios and the results from the glucose meter and perform a least squares analysis (such as through utilization of the LINEST function in MICROSOFT EXCEL) to determine how many rows of ratios within the ratio matrix of Figure 14 consistently correlate to glucose levels.
• a least squares analysis such as through utilization of the LINEST function in MICROSOFT EXCEL
• the term "consistently correlate" means that the R 2 value for the ratios within a row is 1 or close to 1. If the R 2 value for the ratios within the row is zero or close to zero, then the row of ratios does not correlate.
• the L-21 algorithm embodiment uses the least squares method to calculate a straight line that best fits the data.
• the accuracy of the line calculated depends on the degree of scatter in the data. The more linear the data, the more accurate the result of the least square analysis.
• a method can also be used to calculate a polynomial that best fits the data, such as a quadratic, cubic, or other higher order polynomial function. If the data cannot be "fitted" with a straight line function, then a polynomial function can be used.
• the R 2 value, slope and y-intercept are added to a preliminary registration table, as illustrated in Figure 15. Once all of the rows within the ratio matrix of Figure 14 have been evaluated and the table of Figure 15 has been completely populated, the table is sorted to determine the 21 ratios with the highest R 2 values. These 21 ratios and each corresponding R 2 value, slope and y-intercept become the user's or patient's registration table. As with other numbers noted herein, the number of 21 ratios may not ultimately yield the best result for each patient or all patients.
• the 21 ratios with the highest R 2 values seem to offer the best predictability of other numbers tried.
• An embodiment can use less than 21 ratios or more than 21 ratios.
• picking ratios with the highest R 2 values excludes certain ratios that include important information for other reasons. For example, it may turn out that knowing which ratios have R 2 values closest to zero can be important for other reasons, such as determining the presence and quantity of other substances in the sample, such as a protein or another molecule aside from glucose.
• the registration table Once the registration table has been completed for a patient, it can be used to predicatively determine the patient's glucose level when it is not also known through use of a glucose meter. Hence, a scan of the patient would be performed and analyzed in view of the registration table to determine the patient's glucose level at the time of the scan.
• the formula used to predict glucose levels is as follows:
• Pi is a predicted glucose level and R m is the measured ratio that corresponds to the slope and y-intercept. This prediction is then performed for each of the 21 ratios in the patient's registration table and the result of the 21 predictions is averaged to determine the patient's glucose level at the time of the scan.
• Call algorithm utilizes data collected from spectral data sets and executes a calculation at each sample frequency that asks: Is this a spectra for a specific person, such as "Harra”? If the answer comes back "Harra", that frequency is tagged as “True Call” for Harra, and the next frequency is tested. This procedure was repeated for each of a number of other people in a data file, and out of the 3,200 frequencies, 988 frequencies correctly identified one of the people in the data file at least half the time. Even if only 20 frequencies correctly identified a person half the time, the chance that someone would be mis-identified would be 0.5 20 , which equals 0.00000095.
• the True-Call algorithm approach can also be used to identify something by taking a new spectra (spectral data set) and comparing it against a "Library" of known substances, such as wines, liquids, known glucose/distilled water solutions in sealed test tubes, etc.
• the True-Call algorithm consists of an enrollment phase and an identification phase.
• Figure 16 shows a flowchart 1600 describing the enrollment process of the True-Call method. Enrollment begins by inserting the item of interest, the sample, such as a finger, into a scanning apparatus, step 1602, and capturing either one or more spectra, step 1604 as further described below. If multiple spectra are captured, the multiple spectra can be averaged in order to improve the signal to noise ratio.
• spectra refers to spectral data sets of pairs of frequency and corresponding signal amplitude measurements.
• the signal amplitude can be for transmitted, reflected, total net power, or a related component normalized or not.
• the types of item to be scanned can include many different items, including wines, other liquids, objects, etc.
• Step 1604 performs a scan sweep of the item of interest to collect the spectra data.
• the data collected is stored in a database or in an alternative storage system, step 1606.
• Step 1608 checks to see whether enough scans have been collected. If additional scans are needed; then the user is prompted to insert the item of interest into the scanning apparatus again in step 1602. This number can depend on the nature of the sample, with biological samples requiring more scans due to variations in the sample with each scan (fingers inserted at different depths, fingers turned, fingers sweaty and then dry, fingers applying more pressure inside the scanning apparatus one time and less the next, etc.).
• step 1610 After enough scans have been collected, the data is inspected for gross errors, step 1610, by calculating the average, standard deviation, and sum of standard deviations of the spectral data scans. This procedure allows for the identification of erroneous or questionable spectra taken at the wrong moment, such as when the item was moving instead of being at rest. If the data is erroneous or questionable, step 1612, then the enrollment process is restarted, step 1614.
• step 1616 finds predictive frequencies for the item of interest. For every given frequency, the frequency is polled by asking whether the spectra is a specific instance of an item. For example, if the True Call algorithm is being used to identify a user X, each frequency would be polled by asking whether the spectra at the given frequency is a spectra for user X. If the response was user X, then that frequency is tagged using a number, a Boolean, a string, or some other type of identifier.
• the polling is done by taking each scanned spectra K from the multiple scanned spectra, and then identifying the average spectra value along each frequency J which most closely matches the value at frequency J of the scanned spectra K. If the average spectra value which most closely matches is the average spectra value of the current item of interest being enrolled, then the frequency J is tagged as correctly identifying the item of interest.
• the spectra for each item can be stored in a database or stored in a simple text file as raw text or organized using a markup language such as XML.
• the average of the enrollment spectra can also be stored in some fashion.
• the average value of the enrollment spectra can be updated by conducting a second enrollment and capturing a second set of enrollment spectra.
• the raw data from the first enrollment can also be combined with the raw data from the second enrollment, with the average of the first and the second enrollments combined being computed.
• the first enrollment and the second enrollment can also be combined, and the combined enrollment spectra filtered in various ways. For example, outliers can be discarded, or spectra more than one standard deviation from the mean can be discarded, etc.
• the user may also choose to manually discard spectra enrollment if the identification process performs below a desired accuracy. For example, during a biometric application, a user may have positioned the wrong finger in the scanning apparatus during enrollment, or the user may have positioned the finger consistently in the wrong orientation, • making it appear as if the enrollment spectra were correct when it was not. In this case, if the user was not identified properly after several tries, then the user could clear the existing enrollment spectra and conduct another enrollment.
• the average of multiple enrollment spectra differential amplitudes are used to identify the item.
• an item is placed in the scanning apparatus and spectra over a range of frequencies or over specific frequency values are captured. The captured frequencies of the unknown item are compared against the database.
• the frequency J is used as the search index to obtain average spectra values, obtained during enrollment, that match the frequency J. By checking whether any of the entries along each frequency match the captured spectra value associated with frequency J. If an exact match is not found for the spectra value at frequency J in the entries in the database for frequency J, then the average spectra that is closest in value to spectra value is marked as the matching spectra.
• a counter is incremented for the matching average spectra. After all frequencies in the table or database have been checked, a first candidate associated with the highest matching count is identified as the correct candidate. If a count difference between the first candidate with the highest matching count and a second candidate with the second highest matching count is X, then an estimate of probability of misidentification of the first candidate is 0.5 x . For example, if the first candidate had a matching count of 1,000, and the second candidate had a matching count of 800, then the probability of misidentification of the first candidate would be approximately o.5 (1 ' 000 800) which is equal to 6.22e-61, which is an astronomically low probability. Even if the count difference had been only 10, the probability of misidentification of the first candidate would have been approximately 0.00098. This makes the True-Call algorithm a very powerful identification tool.
• Figure 17 illustrates a table 1700 used for an embodiment of the True-
• Each column 1708 contains the average spectra differential amplitudes collected during enrollment for a user.
• Each row 1704 contains the transmitted power at various frequencies, starting at frequency Fl through frequency FN.
• the table may also be structured in other ways, or additional tables may be used to store additional information.
• the actual raw data readings may be stored in a separate table, with table 1700 only containing the average values from the separate table.
• the True-Call algorithm iterates over every row 1704 in table 1700, identifying the column entry along each frequency which most closely matches the unknown spectra value at each frequency. For example, row 1704 for frequency Fl would be searched to identify the column 1702 which most closely matches the unknown spectra value at frequency Fl.
• neighbors across frequencies are counted as well.
• Figure 18 shows a flow chart 1800 of the identification phase. Step
• Step 1802 prompts the user to insert an unknown sample into the scanning apparatus.
• Step 1804 performs a scan or sweep, and step 1806 checks whether enough sweeps have been collected. If additional sweeps are needed then the user is prompted to insert the unknown sample into the scanning apparatus in step 1802.
• the data collected is inspected for gross errors in step 1808 by computing the average, standard deviation, and sum of standard deviations of the spectra data sets. This procedure allows for the identification of erroneous or questionable spectra taken at the wrong moment, such as when the unknown sample was moving instead of being at rest. If the data is erroneous, step 1810, then the identification process is restarted, 1812. If the data is error free, then step 1814 finds spectra frequency matches in the database. This consists of taking the average of the values along each frequency of the scanned spectra and finding the closest matches along each frequency in the database, as described above.
• Step 1816 counts the number of hits or matches for each candidate in the database.
• Step 1818 identifies the candidate with the greatest hit count, and step 1820 computes the probability of the candidate having been identified incorrectly (incorrect probability). If the incorrect probability is less than an unknown candidate threshold Tl, step 1822, then the user is notified that the unknown sample could not be identified, step 1824. If the incorrect probability is greater than or equal to the unknown candidate threshold Tl, but still less than a confidence threshold T2, step 1826, then the suspected candidate identified is confirmed with a second unique identification algorithm, step 1828, further disclosed herein. If the incorrect probability is greater than or equal to the confidence threshold T2, step 1826, then the user is notified of a successful identification and the candidate ID is presented to the user, step 1830.
• a second unique frequency algorithm is used to confirm the suspected candidate selected.
• the second algorithm ranks the top few likely candidates selected, say G3, Gl, and G4, in order to confirm the candidate selected by using a set of frequency values that are more or less unique to each specific candidate's spectra.
• the unknown spectra are interpreted for each of the top few likely candidates at only those unique frequencies in the unique frequencies table corresponding to the top few likely candidates. If the unknown spectra are for one of the likely candidates, say G3, a comparison of the unknown spectra amplitudes with the amplitudes in G3's enrollment spectra at each of G3's unique frequencies will show relatively small differences. This comparison can be performed by calculating the square of the difference between the unknown spectra amplitudes and the amplitudes in G3's enrollment spectra at each unique frequency and then calculating the sum of these squared differences.
• Figure of Merit for G3 (sum of (differences at G3's unique frequencies between unknown spectra amplitudes and G3's enrollment spectra amplitudes) 2 ) X (number of frequencies scanned in spectra) /((average of absolute amplitude of G3's enrollment spectra) 2 X number of G3's unique frequencies).
• a new unknown spectra is identified as being user G3 with the True Call algorithm, but Gl and G4 are the next most likely choices.
• the second unique frequency algorithm verifies that the new unknown spectra belong to user G3 by comparing the figures of merit described above and selecting the candidate with the lowest figure of merit. If the differences between the figures of merit for user G3 and users Gl and G4 exceed a threshold value, or exceed a number of standard deviations, then the identity is confirmed.
• An embodiment consists of a biometric identification algorithm, where one or more independent algorithms separately analyze a biometric scan (a scan performed of a person using a scanning apparatus), and each makes an identification determination.
• the identification determination from each algorithm counts as a vote for a potential identity candidate, with the potential identity candidate with the most votes being the actual identity identification.
• the identification determination from the one or more independent algorithms can be combined in other ways, such as by applying different weights to the contributions by each algorithm.
• the one or more independent algorithms can also be used in combination, such as by applying them sequentially, with the output of a first algorithm feeding into the input of a second algorithm.
• the first algorithm can reduce the identity of a user or a sample to a set of candidates.
• the set of candidates can be input into the second algorithm, which further reduces the set of candidates to a second set of candidates.
• the second set of candidates can subsequently be input into a third algorithm, with the process ending when the output of one of the algorithms is a single candidate or if the set of candidates cannot be further reduced after passing through the various algorithms.
• a minimum identification threshold can be used to discard majority scores or votes if the total score or votes for a potential candidate are below the minimum identification threshold. If an algorithm received the majority weighted score of 55, but a minimum identification threshold was set at 60, then the result would be an unknown.
• the weights assigned to the result of the various algorithms can be set based on empirical observations. For example, if it is known that an algorithm A is particularly robust to noise, then a higher weight can be assigned to the result of algorithm A. Likewise, an algorithm that does not have robust performance can be used as a supplementary algorithm and assigned a lower score, providing support to more robust algorithms. Alternatively, the choice of algorithms used and the corresponding weights can be dynamically varied depending on one or more conditions.
• These conditions can include the current temperature of the sample, current ambient temperature, and the amount of pressure applied by the sample during measurement. If algorithm B is known to perform well under certain conditions, such as when the sample's temperature is above or below a certain point, or when using a certain frequency group, then it can be assigned a higher weight when those conditions are identified. Other conditions can depend on transient conditions, such as the time of day. For example, if an embodiment is being used for biometric identification of users, then the algorithms used or the choice of weights used for each algorithm can be adjusted during and after lunch times. If it is expected that users will consume food during lunch times and with this likely to raise the average glucose level of users, then this can be taken into consideration.
• a user goes through a registration process with the goal of building a unique identity profile (identity profile) for the user, the unique identity profile subsequently stored in a database or other storage system.
• identity profile identity profile
• the identification is not restricted to users, but can also be applied to liquids or other solid substances. From here on, the term "sample” will be used to refer to either a user or other material.
• the biometric identification of the sample is done on a determination process.
• a sweep consists of placing the patient's finger, or some other sample of interest, in the scanning apparatus, wherein the transmitter transmits a series of RF signals starting at a base frequency and stepping up numerous times to higher frequencies until reaching a maximum frequency, or only scans at a number of predetermined frequencies. Numerous different frequency ranges can be utilized. An embodiment uses a frequency range between about 10 MHz and about 12 GHz. The number of steps taken within the frequency range can also vary significantly. An embodiment uses an equal number of about 3,200 sampling points. The total transmitted power signal received by the receiver at each of the
• 3,200 sampling points is then recorded and processed.
• a sample of interest is scanned multiple times using an embodiment of the scanning apparatus. Each scan is referred to as a sweep.
• the user's finger can be scanned.
• a small amount of the liquid can be placed inside a test tube or some other container which can be fitted inside the scanning apparatus.
• the flow through sensor can also be used for the registration process.
• An embodiment of the unique identity profile consists of recorded measurements by the scanning apparatus, and the result of various analyses conducted on the recorded measurements. A subset of the information stored for each user in the database is used to subsequently determine the identity of a user during a determination process.
• a single sweep is used to build the identity profile for the user, such identity profile subsequently being used to verify the identity of the user.
• a higher number of sweeps increases the accuracy of the system, as the numerous sweeps allow for normal variations in the user to be recorded and for noise in the data, whether due to improper sample positioning or too much pressure applied by the sample, to be filtered out.
• the number of sweeps is five or more, although fewer sweeps could be used.
• the identification of a sample is not restricted to users.
• the identification can be used to identify properties of a sample.
• a sample can consist of a fluid in a tube inserted into the scanning apparatus.
• a profile of the fluid can be built on the database and subsequently used for identifying fluids with similar properties.
• the authenticity of liquids and other objects, such as money, bonds, antiques, documents, etc. can be verified.
• a frequency cluster consists of one or more frequency values picked manually through observation of the spectra for a number of people based on two criteria: (1) the variation among the different people needs to be significantly large; and (2) the variation for the same person at difference scans needs to be relatively small.
• the frequency values picked for the clusters may be dependent on the sample and the intended application. For a biometric identification application where the sample is a finger, a total of about 16 frequency clusters are utilized that each fall within a spectrum between about 2.0 GHz and about 6.3 GHz.
• the frequency points in each cluster are contiguous frequencies that were generated by the transmitter 18.
• Clusters are utilized to achieve relative stability of measurement components. Once the clusters are selected, the average or mean values of the amplitude data within each cluster is calculated and used as a single "point".
• the calculated means or averages for a cluster from the 16 clusters for each sweep include average values of the amplitude measurements for the cluster, but can also include average slopes for the cluster, average curvature for the cluster, and the log magnitude sum for the cluster. Hence, each cluster becomes a single point consisting of a set of points and associated data.
• the fourth step calculates statistics for each cluster over all the sweeps. For example, if there were a total of five sweeps, each sweep with 16 clusters, then the' statistics would look at the first cluster from the first sweep, the first cluster from the second sweep, the first cluster from the third sweep, the first cluster for the fourth sweep, and the first cluster from the fifth sweep, etc., continuing with the other 15 clusters.
• the statistics include calculating the average and the standard deviation for the measurements, the average and the standard deviation for the slopes, and the average and the standard deviation for the curvatures.
• the fifth step sorts the cluster order based on the average sum of log magnitude over all the sweeps.
• the maximum four cluster numbers and the minimum four cluster numbers are determined based on the sorted cluster order.
• the sixth step calculates the sum of difference squared for each sweep using cluster averages.
• the sums include the sum for measurements, the sum for slopes, and the sum for curvatures.
• the seventh step calculates statistics for the sums of difference squared.
• the statistics include the average sum of difference squared for measurements, the average sum of difference squared for slopes, the average sum of difference squared for curvatures, the standard deviation of the sum of difference squared for measurements, the standard deviation for the sum of difference squared for slopes, the standard deviation of the sum of difference squared for curvatures.
• the final step sets the tolerances.
• the measurement difference squared tolerance is set to four times the standard deviation of the measurement difference squared.
• the slope difference squared tolerance is set to four times the standard deviation of the slope difference squared.
• the curvature difference squared tolerance is set to four times the standard deviation of the curvature difference squared.
• a set of fields corresponding to measurements and statistics computed for a person can be stored in a database.
• the information stored in the database for each person can include the average of difference squared for measurements, measurement of difference squared tolerance, average sum of difference squared for slopes, slope difference squared tolerance, average sum of difference squared for curvatures, curvature difference squared tolerance, the M maximum sum of log magnitude frequency clusters, and the N minimum sum of log magnitude frequency clusters.
• a set of additional reserved parameters may also be saved on the database for each user. For example, one of the additional reserved parameters can store the standard deviation of the sum of difference squared for measurements.
• An embodiment of the determination process begins by performing a scan sweep.
• Raw data is collected at the N frequency clusters, where N may be 16 or an alternative number of frequency clusters.
• average values are calculated for the clusters.
• the average values for each cluster include the average values of measurements, the average slopes, and the average curvature.
• Other statistics computed for each cluster include calculating the log magnitude sum for each cluster. Sorting the cluster order for the sum of log magnitude. The maximum four cluster numbers and the minimum four cluster numbers are determined based on the sorted cluster order.
• the first step consists of calculating the sum of difference squared against people in the database.
• the sum of difference squared can be computed for measurements, for slope, for curvature, or for some other property.
• the second step finds a set of candidates in the database that have the smallest sums of difference squared.
• the third step checks the tolerance of the sum of difference squared for each candidate in the set of candidates. Overlap among the set of candidates with the lowest sum of difference squared are determined by checking whether intervals of two or more candidates overlap, with an interval starting at a minimum overlap point and ending at a maximum overlap point. The low end of the interval for a candidate is computed by subtracting the tolerance value from the sum of difference squared. The high end of the interval for a candidate is computed by adding the tolerance value to the sum of difference squared.
• a determination is made using a determination candidate from the set of candidates with the lowest sum of difference squared.
• the measured sum of difference squared is compared against the average sum of difference squared for the determination candidate. If the sum of difference squared is within the tolerance interval, then the determination candidate is identified as the correct identity and the determination process completes. If the sum of the difference squared is outside of the tolerance interval, then the identity cannot be determined and is unknown, and the determination process completes.
• the database is checked for each candidate in the set of candidates. In an embodiment, only the candidates in the set of candidates that have any overlap are checked in the database. Alternatively, if there is overlap between two candidates in the set of candidates, but the two candidates are not the candidates with the lowest sum of difference squared among the set of candidates, then only the candidate with the minimum sum of difference squared is checked in the database.
• the step of checking in the database consists of comparing the sum of the measured sum of difference squared with the average sum for the candidates in the set of candidates. If the sample sum of difference squared is within tolerance of the average sum of difference squared for the candidates in the set of candidates, then all candidates in the set of candidates are possible identification candidates. If the sample sum of difference squared is outside of the tolerance, then the sample is unknown and a determination cannot be made.
• a candidate in the database is compared against a sample during determination by first checking the cluster numbers with the maximum sum of log magnitude. Second, checking the cluster numbers with the minimum sum of log magnitude.
• N maximum sum of log magnitude cluster numbers and M minimum sum of log magnitude cluster numbers would be identified. For example, if there are a total of 16 frequency clusters, with N equal to 4 and M equal to 4, then the four maximum sum of log magnitude cluster numbers and the four minimum sum of log magnitude are identified. In an embodiment, N is not equal to M. Sorting a sequence of numbers and identifying the maximum N elements and the minimum M elements of the sorted, or unsorted, sequence is well known in the art and need not be further described herein.
• N maximum sum of log magnitude clusters and the M minimum sum of log magnitude clusters of a possible candidate in the database are compared against the unknown sample.
• a set of points can be awarded based on a set of matching criteria.
• These matching criteria can include the N maximum sum of log magnitude cluster numbers (NLOGMAX) matching in order, matching out of order, or not matching at all, and similarly for the M minimum sum of log magnitude cluster numbers (MLOGMIN).
• NLOGMAX N maximum sum of log magnitude cluster numbers
• MLOGMIN M minimum sum of log magnitude cluster numbers
• NLOGMAX and four entries in MLOGMIN then the entries in NLOGMAX can be "15 03 08 12" and the entries in MLOGMIN can be "02 11 14 05", with "15” being the cluster number with the highest sum of log magnitude number out of all 16 frequency clusters, and where 12 is the smallest of the four maximum sum of magnitude cluster numbers.
• the cluster number "02" in MLOGMIN is the smallest sum of log magnitude number out of all 16 frequency clusters, and "05" is the highest of the four minimum sums of magnitude cluster numbers.
• the matching rules include taking into consideration the order of the elements in the NLOGMAX and MLOGMIN, then the elements in NLOGMAX and MLOGMIN can be sorted, either in increasing or decreasing order.
• the sorting order matches the sorting order used with the unknown sample, since MLOGMIN of a candidate in the database is sorted in increasing order, and the MLOGMIN of the unknown sample is sorted in decreasing order, then this would yield erroneous order matching.
• matching begins by iterating over NLOGMAX of either the unknown sample or a candidate.
• the first element from NLOGMAX in the unknown sample is searched for in NLOGMAX of the candidate. If the first element is found in both NLOGMAX of the unknown sample and of the candidate, then a certain amount of points can be awarded. If the positions are the same, in this case both being the first element of the respective NLOGMAX, then additional points can be awarded.
• the entry "15" at the top of column 1902 out of columns 1900 and 1902 is a match out of order, because the entry "15" is in the first position in column 1902, but it is in the second position in column 1904 for the candidate row 1910.
• the entry "12" in column 1902 is a match in order because it is also in the last position in column 1904 for the candidate row 1910.
• the rest of the entries are not matches.
• column 1906 entries of "14" and "05” are matches in order, whereas the rest of the entries are not matches.
• points are added to a matching score depending on the type of match. Two points can be added to the matching score if a match in order is found, one point can be added to the matching score for a match out of order, and zero points are added in case of no matches.
• the matching rules and the corresponding points received for a partial or complete match are customizable. Other matching rules can be devised. A match in order can receive points equal to half of the length of either NLOGMAX or NLOGMIN, whereas a match in order can receive points equal to a quarter or some other fraction of the length of NLOGMAX or NLOGMIN.
• the matching score is used for determination of the identity of the unknown sample.
• the total matching score is compared against a matching threshold. If the total matching score is below the matching threshold, then the unknown sample is unknown and no determination can be made.
• the matching threshold can be varied in order to increase or decrease the accuracy of the identification of the unknown sample.
• An additional biometric or other sample identification algorithm embodiment consists of a template for each user, consisting of 128 frequencies for each of the four components measured by the scanning apparatus.
• the four components are the real and imaginary components of transmitted RF signals and the real and imaginary components of reflected RF signals.
• the set of 128 frequencies defines a template.
• the test consists of comparing a measurement taken with the template. Then the matches are counted between the measurement and the template, and if a match of about 75% or higher is achieved, then it is a correct identification of the user.
• a range can also be defined. The average score for people is expected to be in the 50% range, since the template itself is defined on a composite average.
• the template for a user is generated by determining how a user's signal amplitude compared to the norm at the given frequency. If the user's value is above the norm or standard value, then the result at that given frequency is encoded as a 1. On the other hand, if the user's value is below the norm, then the result at that given frequency is encoded as a 0. This consists of the process of registering a user and the set of Is and Os for the four components define a template or code for a person.
• the scanning apparatus measurements for the first user are compared with the norm, as during the registration process.
• the determination of the first user is done by counting the number of matches of Is and Os in the determination scan with the registration scan. The count is computed as a percentage of the total possible number of matches. For example, if there are a total of four columns with 128 frequencies, for a total of 512, then the percentage out of 512 that match would give a measurement of determination.
• each column or component has a minimum requirement it must meet. For example, each of the four components must match at least 70% or at least 60%, instead of combining them all together. This would prevent one component from having a 90% match and a second component from having a 60% match, which would not yield an accurate determination.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Physics & Mathematics (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Animal Behavior & Ethology (AREA)
• Pathology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Optics & Photonics (AREA)
• Emergency Medicine (AREA)
• Investigating Or Analysing Materials By Optical Means (AREA)

Applications Claiming Priority (5)

Publications (1)

Family

ID=42198486

Family Applications (1)

Country Status (2)

Families Citing this family (5)

Family Cites Families (5)

• 2009
  • 2009-11-18 EP EP09828179A patent/EP2352419A1/de not_active Withdrawn
  • 2009-11-18 WO PCT/US2009/065015 patent/WO2010059744A1/en active Application Filing

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events