Source: http://www.google.com/patents/US20090192724?dq=6462713
Timestamp: 2015-09-01 20:47:43
Document Index: 617017906

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

Patent US20090192724 - Transcutaneous analyte sensor - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host....http://www.google.com/patents/US20090192724?utm_source=gb-gplus-sharePatent US20090192724 - Transcutaneous analyte sensorAdvanced Patent SearchPublication numberUS20090192724 A1Publication typeApplicationApplication numberUS 12/364,786Publication dateJul 30, 2009Priority dateAug 1, 2003Also published asUS7774145, US8000901, US8311749, US8321149, US8915849, US20060222566, US20100305869, US20110231107, US20110257895Publication number12364786, 364786, US 2009/0192724 A1, US 2009/192724 A1, US 20090192724 A1, US 20090192724A1, US 2009192724 A1, US 2009192724A1, US-A1-20090192724, US-A1-2009192724, US2009/0192724A1, US2009/192724A1, US20090192724 A1, US20090192724A1, US2009192724 A1, US2009192724A1InventorsJames H. Brauker, Apurv Ullas Kamath, Paul GoodeOriginal AssigneeDexcom, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (7), Referenced by (121), Classifications (27), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetTranscutaneous analyte sensor
US 20090192724 A1Abstract
a substantially continuous glucose sensor that produces a data stream indicative of a glucose concentration in a host, the data stream comprising a plurality of time spaced sensor data points; an integrated receiver that receives the data stream from the substantially continuous glucose sensor, wherein the integrated receiver comprises:
an in vitro single point glucose monitor configured to receive a biological sample from the host and to measure the concentration of glucose in the sample;
instructions configured to cause the processor to calibrate the data stream received from the continuous glucose sensor;
instructions configured to cause the processor to determine a rate of change of the calibrated data stream from the substantially continuous analyte sensor; and
instructions configured to cause the processor to not re-calibrate and/or update calibration of the data stream using a glucose concentration measured by the single point glucose monitor when the rate of change of the calibrated data stream is determined to be aberrant, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−2 mg/dL/min.
2. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−3 mg/dL/min.
3. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−4 mg/dL/min.
4. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−5 mg/dL/min.
5. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−6 mg/dL/min.
6. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−10% over 5 minutes and/or +/−2 mg/dL/min.
7. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−15% over 5 minutes and/or +/−3 mg/dL/min.
8. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−20% over 5 minutes and/or +/−4 mg/dL/min.
9. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−25% over 5 minutes and/or +/−5 mg/dL/min.
10. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−30% over 5 minutes and/or +/−6 mg/dL/min.
11. The device of claim 1, wherein the integrated receiver comprises a user interface, wherein the user interface is configured to request a biological sample for measurement via the single point glucose monitor only when the rate of change of the calibrated data stream is not determined to be aberrant.
12. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor to receive user information from an external source and process the user information received from the external source.
13. The device of claim 12, wherein the user information comprises information selected from the group consisting of mealtime information, exercise information, insulin administration, therapy recommendations and reference analyte values.
14. The device of claim 1, wherein the computer readable memory further comprises instructions configured to detect at least one condition selected from the group consisting of present hypoglycemia, predicted hypoglycemia, present hypergylcemia and predicted hypoglycemia, wherein the instructions are configured to trigger an alarm or alert in response to the detection.
15. The device of claim 1, wherein the integrated receiver comprises a user interface configured to display continuous glucose sensor data and single point glucose monitor data.
16. The device of claim 1, wherein the computer readable memory further comprises instructions configured to process and send data to an external device.
17. The device of claim 16, wherein the instructions configured to process and send data to an external device are configured to process and send at least one of an alert, a warning, and a message to a telecommunication device.
18. The device of claim 16, wherein the instructions configured to process and send data to an external device are configured to process and send a therapy recommendation to an insulin delivery device.
19. The device of claim 18, wherein the therapy recommendation comprise at least one of an amount insulin and a time for insulin delivery.
20. The device of claim 16, wherein the external device comprises at least one device selected from the group consisting of a pacemaker, an infusion device, and a telemetry device.
21. The device of claim 1, wherein the computer readable memory further comprises instructions configured to receive and process a therapy recommendation from an external source.
22. The device of claim 1, wherein the computer readable memory further comprises instructions configured to receive and process software updates from an external source.
23. The device of claim 1, wherein the dimensions of the integrated receiver comprise a length of less than about 15 cm, a width of less than about 10 cm, and a thickness of less than about 3.5 cm.
24. The device of claim 1, wherein a volume of the integrated receiver is less than about 180 cm3.
25. The device of claim 1, wherein a weight of the integrated receiver is less than about 130 g.
26. The device of claim 1, wherein the integrated receiver comprises a cell phone.
27. A device for monitoring glucose concentration in a biological sample of a host, the device comprising:
a substantially continuous glucose sensor that produces a data stream indicative of a glucose concentration in a host, the data stream comprising a plurality of time spaced sensor data points; a receiver that receives the data stream from the substantially continuous glucose sensor, wherein the receiver comprises:
a single point glucose monitor configured to receive a biological sample from the host and to measure the concentration of glucose in the sample;
instructions configured to cause the processor to not re-calibrate and/or update calibration of the data stream when the rate of change of the calibrated data stream is determined to be aberrant, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−2 mg/dL/min.
28. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−3 mg/dL/min.
29. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−4 mg/dL/min.
30. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−5 mg/dL/min.
31. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−6 mg/dL/min.
32. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−10% over 5 minutes and/or +/−2 mg/dL/min.
33. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−15% over 5 minutes and/or +/−3 mg/dL/min.
34. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−20% over 5 minutes and/or +/−4 mg/dL/min.
35. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−25% over 5 minutes and/or +/−5 mg/dL/min.
36. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−30% over 5 minutes and/or +/−6 mg/dL/min.
37. The device of claim 27, wherein the receiver comprises a user interface, wherein the user interface is configured to request a biological sample for measurement via the single point glucose monitor only when the rate of change of the calibrated data stream is not determined to be aberrant.
38. The device of claim 27, wherein the computer readable memory further comprises instructions configured to cause the processor to receive user information from an external source and process the user information received from the external source.
39. The device of claim 38, wherein the user information comprises information selected from the group consisting of mealtime information, exercise information, insulin administration, therapy recommendations and reference analyte values.
40. The device of claim 27, wherein the computer readable memory further comprises instructions configured to detect at least one condition selected from the group consisting of present hypoglycemia, predicted hypoglycemia, present hypergylcemia and predicted hypoglycemia, wherein the instructions are configured to trigger an alarm or alert in response to the detection.
41. The device of claim 27, wherein the receiver comprises a user interface configured to display continuous glucose sensor data and single point glucose monitor data.
42. The device of claim 27, wherein the computer readable memory further comprises instructions configured to process and send data to an external device.
43. The device of claim 42, wherein the instructions configured to process and send data to an external device are configured to process and send at least one of an alert, a warning, and a message to a telecommunication device.
44. The device of claim 42, wherein the instructions configured to process and send data to an external device are configured to process and send a therapy recommendation to an insulin delivery device.
45. The device of claim 44, wherein the therapy recommendation comprise at least one of an amount insulin and a time for insulin delivery.
46. The device of claim 42, wherein the external device comprises at least one device selected from the group consisting of a pacemaker, an infusion device, and a telemetry device.
47. The device of claim 27, wherein the computer readable memory further comprises instructions configured to receive and process a therapy recommendation from an external source.
48. The device of claim 27, wherein the computer readable memory further comprises instructions configured to receive and process software updates from an external source.
49. The device of claim 27, wherein the dimensions of the receiver comprise a length of less than about 15 cm, a width of less than about 10 cm, and a thickness of less than about 3.5 cm.
50. The device of claim 27, wherein a volume of the receiver is less than about 180 cm3.
51. The device of claim 27, wherein a weight of the receiver is less than about 130 g.
52. The device of claim 27, wherein the receiver comprises a cell phone.
This application is a continuation of U.S. application Ser. No. 11/334,876 filed Jan. 18, 2006. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 10/633,367 filed Aug. 1, 2003; and is a continuation-in-part of U.S. application Ser. No. 11/007,920 filed Dec. 8, 2004, which claims priority under 35 U.S.C. � 119(e) to U.S. Provisional Application No. 60/528,382 filed Dec. 9, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and is a continuation-in-part of U.S. application Ser. No. 10/991,966 filed Nov. 17, 2004, which claims priority under 35 U.S.C. � 119(e) to U.S. Provisional Application No. 60/523,840 filed Nov. 19, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and is a continuation-in-part of U.S. application Ser. No. 11/077,715 filed Mar. 10, 2005, which claims priority under 35 U.S.C. � 119(e) to the U.S. Provisional No. 60/587,787 filed on Jul. 13, 2004, U.S. Provisional Application No. 60/587,800 filed Jul. 13, 2004, U.S. Provisional No. 60/614,683 filed Sep. 30, 2004, and U.S. Provisional Application No. 60/614,764 filed Sep. 30, 2004, each of which is incorporated by reference herein in its entirety, and each of which is hereby made a part of this specification.
The term “analyte” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotimidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenyloin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), histamine, and 5-hydroxyindoleacetic acid (FHIAA).
The terms “operably connected” and “operably linked” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to one or more components linked to one or more other components. The terms can refer to a mechanical con