Fluid component analysis system and method for glucose monitoring and control
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-005/00
A61M-031/00
A61M-005/172
A61B-005/155
A61B-005/145
A61B-005/1455
G06F-019/00
A61M-005/168
A61M-005/14
A61M-005/142
출원번호
US-0857949
(2013-04-05)
등록번호
US-9302045
(2016-04-05)
발명자
/ 주소
Rule, Peter
출원인 / 주소
OptiScan Biomedical Corporation
대리인 / 주소
Knobbe, Martens, Olson & Bear, LLP
인용정보
피인용 횟수 :
0인용 특허 :
166
초록▼
Disclosed are methods and apparatuses for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment dose (e.g. insulin, dextrose, etc.) and provide glycemic control. The dose of
Disclosed are methods and apparatuses for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment dose (e.g. insulin, dextrose, etc.) and provide glycemic control. The dose of the treatment drug may be based on the patient's calculated sensitivity to treatment dosing, for example. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte. Delivery of the treatment drug can be cut off if the determined analyte concentration indicates that continued delivery would be harmful to the patient.
대표청구항▼
1. A patient treatment and analysis system, comprising: a body fluid analyzer configured to: measure a concentration of an analyte in a bodily fluid; andaccess an analyte history database and store the measured concentration of the analyte in the analyte history database; anda treatment dosing syste
1. A patient treatment and analysis system, comprising: a body fluid analyzer configured to: measure a concentration of an analyte in a bodily fluid; andaccess an analyte history database and store the measured concentration of the analyte in the analyte history database; anda treatment dosing system in communication with the body fluid analyzer, the treatment dosing system comprising: a source of a treatment substance; anda treatment dosing algorithm stored in a computer memory;wherein the treatment dosing system is configured to: use the treatment dosing algorithm to calculate an estimated treatment sensitivity for the patient by accessing the analyte history database and a dosage history database and comparing portions of the analyte history database to portions of the dosage history database;use the treatment dosing algorithm to calculate a recommended treatment dosage for the patient based at least in part on the estimated treatment sensitivity;administer a dose of the treatment substance to the patient; andaccess a dosage history database and store a record of the administered dose therein;wherein the treatment dosing algorithm is configured to calculate a predicted accuracy of the estimated treatment sensitivity, and wherein the treatment dosing algorithm is configured to calculate the recommended treatment dosage based at least in part on the predicted accuracy of the estimated treatment sensitivity. 2. The patient treatment and analysis system of claim 1, further comprising a communication interface configured to communicate with an external infusion pump, wherein the communication interface is configured to receive infusion information from the external infusion pump and the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the infusion information received from the external infusion pump. 3. The patient treatment and analysis system of claim 1, wherein the analyte is glucose and the treatment substance is insulin. 4. The patient treatment and analysis system of claim 3, wherein the treatment substance is IV insulin. 5. The patient treatment and analysis system of claim 1, wherein the system is configured to perform a measurement cycle more frequency than once per hour. 6. The patient treatment and analysis system of claim 5, wherein the patient treatment and analysis system is configured to perform the measurement cycle at least once every thirty minutes. 7. The patient treatment and analysis system of claim 6, wherein the patient treatment and analysis system is configured to perform the measurement cycle at least once every fifteen minutes. 8. The patient treatment and analysis system of claim 1, further comprising a fluid network that is configured to draw a sample of bodily fluid through a catheter connected to the patient and transport at least a portion of the sample of bodily fluid to the body fluid analyzer, wherein the fluid network is further configured to deliver the treatment dose to the patient using the same catheter used to draw samples of bodily fluid. 9. The patient treatment and analysis system of claim 1, wherein the dose of the treatment fluid administered to the patient is the recommended treatment dosage calculated by the treatment dosing system. 10. The patient treatment and analysis system of claim 1, further comprising a user interface configured to display the recommended treatment dosage to a user and to receive input from the user, and wherein the dose of the treatment fluid administered to the patient is determined at least in part by the input received from the user via the user interface. 11. The patient treatment and analysis system of claim 1, wherein the source of the treatment substance is a non-dedicated reservoir. 12. The patient treatment and analysis system of claim 1, wherein the treatment dosing algorithm is configured to apply a first dosing protocol if the predicted accuracy is above a predetermined level and apply a second dosing protocol if the predicted accuracy is below the predetermined level, wherein the second dosing protocol is more conservative than the first dosing protocol. 13. The patient treatment and analysis system of claim 1, wherein the treatment dosing algorithm comprises a sliding scale dosing protocol having a varying level of aggressiveness that is based at least in part on the predicted accuracy, such that the aggressiveness of the sliding scale dosing protocol increases as the predicted accuracy increases. 14. A patient monitoring and dosing system, comprising: a body fluid analyzer configured to measure a concentration of an analyte in a sample of bodily fluid from a patient; anda treatment dosing system in communication with the body fluid analyzer, said treatment dosing system comprising a treatment dosing algorithm stored in a computer memory, the treatment dosing algorithm being configured to automatically calculate: an estimated treatment sensitivity for the patient based at least in part on the measured concentration of the analyte; anda recommended treatment dosage for the patient, wherein the automatic calculation of the recommended treatment dosage is based at least in part on the estimated treatment sensitivity;wherein the treatment dosing algorithm is configured to calculate a predicted accuracy of the estimated treatment sensitivity, and wherein the treatment dosing algorithm is configured to calculate the recommended treatment dosage based at least in part on the predicted accuracy of the estimated treatment sensitivity. 15. The patient monitoring and dosing system of claim 14, wherein the treatment dosing system further comprises a source of treatment fluid, the treatment dosing system being configured to automatically deliver the recommended treatment dosage to the patient. 16. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a basal infusion, the treatment dosing system being configured to adjust a basal infusion rate to deliver the recommended treatment dosage to the patient, and wherein the basal infusion is halted at least five minutes before the next measurement is taken. 17. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a bolus injection delivered at least five minutes before the next measurement is taken. 18. The patient monitoring and dosing system of claim 15, wherein the body fluid analyzer is configured to periodically measure samples of bodily fluid, and the treatment dosing system is configured to deliver the recommended treatment dosage to the patient at least in part as a bolus injection delivered about midway between sample measurements. 19. The patient monitoring and dosing system of claim 14, further comprising a database in communication with the body fluid analyzer, the database being configured to store a history of measured concentrations of the analyte, wherein the treatment dosing algorithm is configured to access the database and calculate the estimated treatment sensitivity based at least in part on the history of measured concentrations of the analyte. 20. The patient monitoring and dosing system of claim 19, wherein the database is configured to store a history of treatment doses delivered to the patient, and wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the history of treatment doses. 21. The patient monitoring and dosing system of claim 20, wherein the history of treatment doses comprises a plurality of active dose amounts delivered to the patient at different times, and the treatment dosing algorithm is configured to calculate an amount remaining for each of the plurality of active dose amounts based at least in part on a treatment fluid half-life, and the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on the amount remaining for each of the plurality of active dose amounts. 22. The patient monitoring and dosing system of claim 20, wherein the treatment dosing system further comprises a source of treatment fluid, the treatment dosing system being configured to automatically deliver the recommended treatment dosage to the patient, the treatment dosing system being configured to access the database and update the history of treatment doses. 23. The patient monitoring and dosing system of claim 20, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on a comparison of at least a portion of the history of measured concentrations of the analyte to at least a portion of the history of treatment doses. 24. The patient monitoring and dosing system of claim 23, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity using a weighted average, the weighted average giving greater weight to more recent entries in the history of measured concentrations of the analyte and the history of treatment doses. 25. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every hour, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every hour. 26. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every thirty minutes, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every thirty minutes. 27. The patient monitoring and dosing system of claim 19, wherein the body fluid analyzer is configured to measure a new concentration of the analyte and update the history of measured concentrations of the analyte at least once every fifteen minutes, and the treatment dosing algorithm is configured to calculate a new estimated treatment sensitivity and a new recommended treatment dosage at least once every fifteen minutes. 28. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to apply a first dosing protocol if the predicted accuracy is above a predetermined level and apply a second dosing protocol if the predicted accuracy is below the predetermined level, wherein the second dosing protocol is more conservative than the first dosing protocol. 29. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm comprises a sliding scale dosing protocol having a varying level of aggressiveness that is based at least in part on the predicted accuracy, such that the aggressiveness of the sliding scale dosing protocol increases as the predicted accuracy increases. 30. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to calculate an expected analyte concentration range based at least in part on the estimated treatment sensitivity, and the treatment dosing algorithm is configured to trigger an alert if the measured analyte concentration falls outside the expected analyte concentration range. 31. The patient monitoring and dosing system of claim 14, wherein the treatment dosing algorithm is configured to calculate the estimated treatment sensitivity based at least in part on additional patient data, the additional patient data including patient feeding information, patient medication information, or patient exercise information. 32. The patient monitoring and dosing system of claim 14, wherein the body fluid analyzer is configured for glucose control solution calibration no more than once per day. 33. The patient monitoring and dosing system of claim 14, wherein the body fluid analyzer is configured for glucose control solution calibration no more than once each week. 34. The patient monitoring and dosing system of claim 14, further comprising a fluid network connected to the patient and the body fluid analyzer, the fluid network configured to draw a sample of bodily fluid through a catheter connected to the patient and transport at least a portion of the sample of bodily fluid to the body fluid analyzer for measurement. 35. The patient monitoring and dosing system of claim 34, further comprising a source of treatment fluid, and wherein the treatment and dosing system is configured to automatically deliver the recommended treatment dosage to the patient through the same catheter used to draw the sample of bodily fluid. 36. The patient monitoring and dosing system of claim 14, wherein the analyte is glucose and the estimated treatment sensitivity is estimated insulin sensitivity and the recommended treatment dosage is a recommended dose of insulin. 37. The patient monitoring and dosing system of claim 14, wherein the treatment dosing system further comprises a display configured to display the recommended treatment dosage to a user.
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이 특허에 인용된 특허 (166)
Hayes, Andrew C.; Mastrototaro, John J.; Moberg, Sheldon B.; Mueller, Jr., John C.; Clark, H. Bud; Tolle, Mike Charles Vallet; Williams, Gary L.; Wu, Bihong; Steil, Garry M., Algorithm sensor augmented bolus estimator for semi-closed loop infusion system.
Lebel, Ronald J.; Shahmirian, Varaz; Villegas, Daniel H.; Choy, David Y.; Weiss, Philip T.; Meadows, Paul M., Ambulatory medical apparatus with hand held communication device.
Robinson,Mark Ries; Fleming,Cliona; Jones,Howland; Rohrscheib,Mark, Apparatus and method for non-invasive spectroscopic measurement of analytes in tissue using a matched reference analyte.
Davis, III,Herbert T.; Rowe,Robert K.; Vanslyke,Stephen J., Apparatus and method for spectroscopic analysis of tissue to detect diabetes in an individual.
Brimhall Owen D. (West Valley City UT) Peterson Stephen C. (Salt Lake City UT) Baker Charles D. (Sandy UT) Riddle Merwyn D. (Salt Lake City UT), Apparatus and method for using ultrasound to determine hematocrit.
Varalli, Maurizio Claudio; Poscia, Alessandro, Apparatus for measurement and control of the content of glucose, lactate or other metabolites in biological fluids.
Van Den Berghe,Greta; Berckmans,Daniel; Aerts,Jean Marie; De Moor,Bart; Pluymers,Bert; De Smet,Frank, Automatic infusion system based on an adaptive patient model.
Barone David (Sharon MA) Herrig Russell (Sharon MA) Kaleskas Edward (Jefferson MA) Porreca Ronald (Needham MA) Stenfors Alan L. (Scituate MA) Vandor Robert (Walpole MA) Medberry Joseph M. (Seekonk MA, Blood processing method and apparatus with disposable cassette.
Braig, James R.; Rule, Peter; Sterling, Bernhard B.; Smith, Heidi M.; Cortella, Julian M.; Gable, Jennifer H., Calibrator configured for use with noninvasive analyte-concentration monitor and employing traditional measurements.
Simons Tad Decatur ; Greenstein Michael ; Freeman Dominique ; Leonard Leslie Anne ; King David A. ; Lum Paul, Cassette of lancet cartridges for sampling blood.
Steil, Garry M.; Rebrin, Kerstin; Goode, Jr., Paul V.; Mastrototaro, John J.; Purvis, Richard E.; Van Antwerp, William P.; Shin, John J.; Talbot, Cary D., Closed loop system for controlling insulin infusion.
Orkin Fredric I. (Deerfield IL) Liber Theodore (Highland Park IL) Smith Charles R. (Libertyville IL) Knowlton Kimball J. (Lindenhurst IL) Huntley Albin (Concord CA), Closed multi-fluid delivery system and method.
Orkin Fredric I. (Deerfield IL) Liber Theodore (Highland Park IL) Smith Charles R. (Libertyville IL) Knowlton Kimball J. (Lindenhurst IL) Huntley Albin (Martinez CA), Closed multi-fluid delivery system and method.
Hull,Edward L.; Ediger,Marwood Neal; Brown,Christopher D.; Maynard,John D.; Johnson,Robert D., Determination of a measure of a glycation end-product or disease state using tissue fluorescence.
Douglas Joel S. ; Radwanski Ryszard ; Duchon Brent G. ; Priest John H. ; Hasker David A. ; Gleisner John M., Device for determination of an analyte in a body fluid.
Bombardieri Guiseppe (Via della Mendola ; 47 Roma ITX), Device for the automatic insulin or glucose infusion in diabetic subjects, based on the continuous monitoring of the pat.
Henning Timothy P. ; Shain Eric B. ; Khalil Gamal ; Elstrom Tuan A., Device for the detection of analyte and administration of a therapeutic substance.
Conn, Thomas E.; Ford, Russell; Potts, Russell O.; Soni, Pravin L.; Tamada, Janet A.; Tierney, Michael J., Devices and methods for frequent measurement of an analyte present in a biological system.
Wong Sie Ting ; Hiltibran Robert G. ; Huang Tung-Ming ; Calfin Brenda B. ; Pope Mark R. ; Schapira Thomas G. ; Shain Eric B. ; Young Douglas F., Diagnostic assay for a sample of biological fluid.
Close, Benjamin W.; Hall, III, Thomas A., Disposable needle assembly having sensors formed therein permitting the simultaneous drawing and administering of fluids and method of forming the same.
Braig, James R.; Keenan, Richard; Rule, Peter; Rivas, Gil; Seetharaman, Mahesh, Fluid component analysis system and method for glucose monitoring and control.
Braig, James R.; Keenan, Richard; Rule, Peter; Rivas, Gil; Seetharaman, Mahesh, Fluid component analysis systems and methods for glucose monitoring and control.
Cusack Robert F. (Edison NJ) Mintz Michael D. (Edison NJ), Fluid sample collection and delivery system and methods particularly adapted for body fluid sampling.
Cusack Robert F. (Edison NJ) Mintz Michael D. (Edison NJ), Fluid sample collection and delivery system and methods particularly adapted for body fluid sampling.
Ford, Russell; Lesho, Matthew J.; Potts, Russell O.; Tierney, Michael J.; Wei, Charles W., Formulation and manipulation of databases of analyte and associated values.
Braig, James R.; Hewett, Gary E.; Munrow, Michael A.; Cortella, Julian M.; Azizi, Kamrava; Goldberger, Daniel S., Glucose monitoring instrument having network connectivity.
Simons Tad Decatur ; Greenstein Michael ; Freeman Dominique ; Leonard Leslie Anne ; King David A. ; Lum Paul, Integrated system and method for sampling blood and analysis.
Erickson Brian J. ; Hilgers Michael E. ; Hendrickson Tracy A. ; Shapland J. Edward ; Solomon Frank A. ; Knudson Mark B., Interstitial fluid collection and constituent measurement.
Simonsen, Jan Henning; Poulsen, Jens Ulrik; Rokkjaer, Kent Halfdan; Christensen, Lars Hofmann; Aasmul, S.o slashed.ren; Iav, Steffen, Medical system and a method of controlling the system for use by a patient for medical self treatment.
Fodgaard Henrik,DKX ; Singer Rolf,DKX ; Fabricius Paul Erik,DKX, Method and an apparatus for determining the content of a constituent of blood of an individual.
Sterling,Bernhard B.; Hall,W. Dale; Witte,Kenneth G.; Wechsler,Mark; Zheng,Peng; Keenan,Richard, Method and apparatus for determining an analyte concentration in a sample having interferents.
Braig, James R.; Kramer, Charles E.; Sterling, Bernhard B.; Goldberger, Daniel S.; Zheng, Peng; Shulenberger, Arthur M.; Trembino, Rick; King, Richard A.; Barnes, Casper W., Method and apparatus for determining analyte concentration using phase and magnitude detection of a radiation transfer function.
Rohrscheib, Mark; Gardner, Craig; Robinson, Mark R., Method and apparatus for non-invasive blood analyte measurement with fluid compartment equilibration.
Cunningham, David D.; Henning, Timothy P.; Shain, Eric B.; Young, Douglas F.; Muetterties, Andrew J.; Schapira, Thomas G.; Chambers, Geoffrey R.; Hughes, Graham J.; Watkin, Jared L.; Prokop, Gary F.;, Method and apparatus for obtaining blood for diagnostic tests.
Dunn, Timothy C.; Jayalakshmi, Yalia; Kurnik, Ronald T.; Lesho, Matthew J.; Oliver, Jonathan James; Potts, Russell O.; Tamada, Janet A.; Waterhouse, Steven Richard; Wei, Charles W., Method and device for predicting physiological values.
Braig James R. ; Kramer Charles E. ; Sterling Bernhard B. ; Goldberger Daniel S. ; Zheng Peng ; Shulenberger Arthur M. ; Trebino Rick ; King Richard A. ; Barnes Casper W., Method for determining analyte concentration using periodic temperature modulation and phase detection.
Braig, James R.; Kramer, Charles E.; Sterling, Bernhard B.; Goldberger, Daniel S.; Zheng, Peng; Shulenberger, Arthur M.; Trebino, Rick; King, Richard A.; Barnes, Casper W., Method for determining analyte concentration using periodic temperature modulation and phase detection.
Robinson,Thomas C.; Robinson,Thomas P.; D'Elia,Richard; Sahines,Thomas; Eibe,Paul, Method of simultaneous blood collection and separation using a continuous flow centrifuge having a separation channel.
Charles W. Scarantino ; H. Troy Nagle ; Leslie C. Hall ; Jeffrey Mueller ; Chang-Soo Kim, Methods, systems, and associated implantable devices for dynamic monitoring of physiological and biological properties of tumors.
Lebel, Ronald J.; Shahmirian, Varaz; Starkweather, Timothy J.; Villegas, Daniel H.; Weiss, Philip T., Microprocessor controlled ambulatory medical apparatus with hand held communication device.
Kramer Charles E. ; Sterling Bernhard B. ; Braig James R. ; Goldberger Daniel S. ; Shulenberger Arthur M. ; Trebino Rick ; King Richard A., Non-invasive infrared absorption spectrometer for the generation and capture of thermal gradient spectra from living tissue.
Khalil, Omar S.; de Mul, Frits F. M.; Hanna, Charles F.; Stalder, Arnold F.; Yeh, Shu-jen; Wu, Xiaomao; Lowery, Michael G.; Kanger, Johannes S.; Bolt, Rene A., Non-invasive sensor having controllable temperature feature.
Sterling, Bernhard B.; Hartstein, Philip C.; Li, Ken I.; Agostino, Mark D.; Klonoff, David C.; Gaffney, Robert D.; Gable, Jennifer H.; Witte, Ken G.; Munrow, Mike A.; Goldberger, Daniel S.; Cortella,, Reagent-less whole-blood glucose meter.
Knute ; deceased Wallace L. ; Wong David K. ; Lucisano Joseph Y. ; Carlisle Thomas J. ; Del Toro Alfonso, Sensor apparatus for use in measuring a parameter of a fluid sample.
Keith,Steven; Parker,Robert S.; Harvey,Noel G.; Pettis,Ronald J.; DeNuzzio,John D.; Vonk,Glenn, System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or .
Starkweather, Timothy J.; Lebel, Ronald J.; Shah, Rajiv; Miller, Michael E., System and method for providing closed loop infusion formulation delivery.
Nayak Abinash ; Jacobson James D. ; Westberg Tom ; Brach William E ; Brown Richard I, System and methods for control of pumps employing electrical field sensing.
Pfeiler Manfred (Erlangen DEX) Mund Konrad (Uttenreuth DEX) Preidel Walter (Erlangen DEX) Sjoeholm Goesta (Ekeroe SEX), System for infusion of medicine into the body of a patient.
Machold Timothy R. (Moss Beach CA) Mar Craig E. (Fremont CA) Mueller ; Jr. Richard L. (Mountain View CA) Shanahan John P. (San Jose CA), Vascular catheters.
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