US2016161404A1PendingUtilityA1

System Using Laser-Scatter Measurement Instrument For Organism Identification And Related Network

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Assignee: BACTERIOSCAN LTDPriority: Dec 5, 2014Filed: Dec 4, 2015Published: Jun 9, 2016
Est. expiryDec 5, 2034(~8.4 yrs left)· nominal 20-yr term from priority
G01N 2201/0612G01N 21/49G06F 19/28C12Q 1/04G16B 50/00G16B 50/30B01L 2300/0681B01L 3/50255G01N 2021/4707B01L 2300/022B01L 2300/045B01L 2200/0684B01L 2300/043G01N 21/51G01N 2021/513B01L 2300/044B01L 2300/0672B01L 2400/0683
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Claims

Abstract

An optical measurement instrument is an integrated instrument that includes an optical cavity with a light source, a sample cuvette, and an optical sensor. The instrument can be used for taking measurements of organism concentration in one or more samples. Preferably, the instrument holds multiple, individually-loaded, independent fluid samples and determines bacteria concentration via a forward-scattering signal. The instrument can incorporate onboard incubation to promote bacterial growth in the samples such that, once a certain bacterial concentration is achieved, the higher concentration sample can be used with a mass spectrometer to identify the type of bacteria. The instrument and mass spectrometer can be a part of a network for medical diagnostic testing data where data is stored in a manner that is inherently untainted by patient identifiable information.

Claims

exact text as granted — not AI-modified
1 . A method of identifying bacteria in a fluid sample, comprising:
 placing the fluid sample in a cuvette having a first window for receiving an input beam and a second window for transmitting a forward-scatter signal indicative of the bacteria in the fluid sample;   incubating the fluid sample in the cuvette within an optical-measuring instrument that provides the input beam;   passing the input beam through the fluid sample while the cuvette is in the optical-measuring instrument;   analyzing the forward-scatter signal from the fluid sample;   in response to the forward-scatter signal indicating the presence of bacteria in the fluid sample, continuing to incubate the fluid sample within the optical-measuring instrument to increase the concentration of the bacteria within the fluid sample;   removing, from the cuvette, the fluid sample having the increased concentration of bacteria; and   placing at least a portion of the bacteria removed from the cuvette in a mass-spectrometry microbial identification device to identify the type of bacteria.   
     
     
         2 . The method of  claim 1 , further including centrifuging the fluid sample after the removing, the centrifuging creating a high-concentration sample of the bacteria for the mass-spectrometry microbial identification device. 
     
     
         3 . The method of  claim 1 , wherein the passing and the analyzing include repeatedly transmitting the input beam through the fluid sample and measuring a series of forward-scatter signals for the fluid samples. 
     
     
         4 . The method of  claim 1 , further including transmitting bacteria-concentration results from the optical-measuring instrument to a database lacking patient identification information. 
     
     
         5 . The method of  claim 4 , further including transmitting bacteria-identification results to the database lacking patient identification information. 
     
     
         6 . A method of identifying bacteria in a fluid sample, comprising:
 placing the fluid sample in a cuvette having a first window for receiving an input beam and a second window for transmitting a forward-scatter signal indicative of the presence of the bacteria in the fluid sample;   in response to a first forward-scatter signal indicating the presence of bacteria, incubating the fluid sample in the cuvette to increase the bacteria concentration;   in response to a second forward-scatter signal indicating a predetermined concentration of bacteria, removing, from the cuvette, the fluid sample having the increased concentration of bacteria; and   placing at least a portion of the bacteria removed from the cuvette in a mass-spectrometry microbial identification device to identify the type of bacteria.   
     
     
         7 . The method of  claim 6 , further including centrifuging the fluid same after the removing, the centrifuging creating high-concentration sample of the bacteria for placement in the mass-spectrometry device. 
     
     
         8 . The method of  claim 6 , wherein the first and second forward-scatter signals are a part of a series of forward-scatter signals that occur during the incubating. 
     
     
         9 . The method of  claim 6 , further including transmitting bacteria-concentration results from the optical-measuring instrument to a database lacking patient identification information. 
     
     
         10 . The method of  claim 9 , further including transmitting bacteria-identification results to the database lacking patient identification information. 
     
     
         11 . A method of identifying bacteria in a fluid sample, comprising:
 placing the fluid sample in a cuvette having a first window for receiving an input beam and a second window for transmitting a forward-scatter signal indicative of the presence or absence of the bacteria in the fluid sample;   incubating the fluid sample in the cuvette within an optical-measuring instrument that provides the input beam;   passing the input beam through the fluid sample while the cuvette is in the optical-measuring instrument;   analyzing the forward-scatter signal from the fluid sample;   in response to the forward-scatter signal indicating the presence of bacteria in the fluid sample, continuing to incubate the fluid sample within the optical-measuring instrument to increase the concentration of the bacteria within the fluid sample and at least partially identify the type of bacteria within the fluid sample.   
     
     
         12 . The method of  claim 11 , further including centrifuging the fluid sample after the continued incubation and placing some of the bacteria from the centrifuging in a mass-spectrometry device to at least partially identify the bacteria. 
     
     
         13 . The method of  claim 11 , wherein the at least partial identification of the type of bacteria includes identifying the species of bacteria. 
     
     
         14 . The method of  claim 11 , wherein the at least partial identification of the type of bacteria is based on a chemoeffector in the cuvette that affects the growth of the bacteria. 
     
     
         15 . The method of  claim 11 , wherein the at least partial identification of the type of bacteria is based on a behavior of the bacteria in response to a certain incubation temperature. 
     
     
         16 . The method of  claim 11 , wherein the at least partial identification bacteria is based on a slope of a bacterial-growth curve at a certain incubation temperature. 
     
     
         17 . The method of  claim 11 , further including, reporting to an operator, when the analyzing indicates the presence of the bacteria above a predetermined bacteria concentration. 
     
     
         18 . The method of  claim 17 , wherein the reporting is in the form of a visual indicator on a display and/or an audio indicator. 
     
     
         19 . The method of  claim 11 , wherein the optical-measuring instrument includes a moveable optical bench having a light source providing the input beam and a sensor for receiving the forward-scatter signal, the movement of the moveable optical bench permitting multiple fluid samples in optical chambers of multiple cuvettes to be individually measured. 
     
     
         20 . A network for collecting and using biological data related to bacteria within fluid samples, comprising:
 a plurality of instruments that are at remote locations, each of the plurality of instruments for testing a forward-scatter signal that is used to determine the presence of a bacteria in a fluid sample from a patient;   a first database for storing a set of raw test data for each fluid sample from the plurality of instruments, each set of raw test data being stored in a manner that is indexed to a test sample ID, the first database lacking any private patient information;   a second database for storing an event record that associates the test sample ID and a patient ID;   a report-generator software module that accesses information from the first database and the second database to develop a test report for each patient; and   a data-mining software module that accesses information from only the first database to determine or predict trends from the raw test data.   
     
     
         21 . The network of  claim 20 , wherein the plurality of instruments determine a bacterial concentration in the fluid samples. 
     
     
         22 . The network of  claim 21 , wherein the plurality of instruments assist with determining a type of bacteria in the fluid samples. 
     
     
         23 . The network of  claim 20 , wherein the raw test data is in the form of bacterial concentration over a period of time. 
     
     
         24 . The network of  claim 20 , wherein each fluid sample is placed in a plurality of cuvettes. 
     
     
         25 . The network of  claim 24 , wherein the plurality of cuvettes includes different chemoeffectors intended to effect bacterial concentration. 
     
     
         26 . The network of  claim 24 , wherein the plurality of cuvettes include coded information that is a part of the test sample ID. 
     
     
         27 . The network of  claim 20 , wherein the data-mining software module accesses the information by queries related to a slope of a curve defining bacterial concentration as a function of time. 
     
     
         28 . The network of  claim 20 , wherein the report-generator software module analyzes the raw test data from the first database to determine a patient's condition. 
     
     
         29 . The network of  claim 20 , further including a third database that is accessible by the report-generator software module, the third database including private patient information that is associated with the patient ID. 
     
     
         30 . The network of  claim 20 , wherein the data-mining software module provides at least one of the group consisting of: (i) a direct comparison of multiple antibiotics against a certain infection, (ii) a direct comparison of the same antibiotic at different concentrations against a certain infection, (iii) a direct comparison of a new drug against known drugs, (iv) an indication of or a detection of an emergence of one or more incidents of resistant infection in any healthcare site or geographic region, (v) an indication of or a detection of a certain type of bacteria has become or may be becoming resistant to a certain antibiotic, (vi) an indication of or a detection of a certain type of bacteria in a certain geographical region has become or may be becoming resistant to a certain antibiotic, (vii) an indication of or a detection of a certain type of bacteria in a certain hospital or care unit has become or may be becoming resistant to a certain antibiotic, (viii) an indication of or a detection of the susceptibility or resistance of an infection pathogen to an antimicrobial agent, molecule, or combination or sequence of exposure of antimicrobial agent or molecule with or without the active involvement of the proximate healthcare providers or clinical microbiologist. 
     
     
         31 . A network for collecting and using biological data related to bacteria within fluid samples, comprising:
 a plurality of instruments that are at remote locations, each of the plurality of instruments for testing a forward-scatter signal that is used to determine the presence of a bacteria in a fluid sample from a patient;   a first database for storing a set of raw test data for each fluid sample from the plurality of instruments, each set of raw test data being stored in a manner that lacks private patient information; and   a data-mining software module that accesses information from only the first database to determine or predict trends from the raw test data related to at least one of the group consisting of: (i) a direct comparison of multiple antibiotics against a certain infection, (ii) a direct comparison of the same antibiotic at different concentrations against a certain infection, (iii) a direct comparison of a new drug against known drugs, (iv) an indication of or a detection of an emergence of one or more incidents of resistant infection in any healthcare site or geographic region, (v) an indication of or a detection of a certain type of bacteria has become or may be becoming resistant to a certain antibiotic, (vi) an indication of or a detection of a certain type of bacteria in a certain geographical region has become or may be becoming resistant to a certain antibiotic, (vii) an indication of or a detection of a certain type of bacteria in a certain hospital or care unit has become or may be becoming resistant to a certain antibiotic, (viii) an indication of or a detection of the susceptibility or resistance of an infection pathogen to an antimicrobial agent, molecule, or combination or sequence of exposure of antimicrobial agent or molecule with or without the active involvement of the proximate healthcare providers or clinical microbiologist.

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