Source: http://patents.com/us-9615780.html
Timestamp: 2019-01-24 00:30:43
Document Index: 302010605

Matched Legal Cases: ['art\n7779332', 'Application No. 08745805', 'Application No. 08745807', 'Application No. 08745803', 'Application No. 08745809', 'Application No. 08754499', 'Application No. 08871628', 'Application No. 2', 'application No. 60']

US Patent # 9,615,780. Method and apparatus for providing data processing and control in medical communication system - Patents.com
United States Patent 9,615,780
Hayter April 11, 2017
Hayter; Gary (Oakland, CA)
Hayter; Gary
Family ID: 1000002513237
12/102,847
US 20080256048 A1 Oct 16, 2008
60911872 Apr 14, 2007
Current CPC Class: A61B 5/14532 (20130101); A61B 5/002 (20130101); A61B 5/1495 (20130101); A61B 5/14865 (20130101); A61B 5/6867 (20130101); A61B 5/74 (20130101); A61B 5/742 (20130101); A61B 5/7405 (20130101); A61B 5/746 (20130101); A61B 2560/0252 (20130101); A61B 2560/0271 (20130101); C12Q 1/54 (20130101)
Current International Class: A61B 5/05 (20060101); A61B 5/145 (20060101); C12Q 1/54 (20060101); A61B 5/1486 (20060101); A61B 5/00 (20060101); A61B 5/1495 (20060101)
5532686 July 1996 Urbas et al.
5804047 September 1998 Karube et al.
5891049 April 1999 Cyrus et al.
5951485 September 1999 Cyrus et al.
6091987 July 2000 Thompson
6144871 November 2000 Saito et al.
6291200 September 2001 LeJeune et al.
6400974 June 2002 Lesho
6574510 June 2003 Von Arx et al.
6635167 October 2003 Batman et al.
6735183 May 2004 O'Toole et al.
6950708 September 2005 Bowman IV et al.
7009511 March 2006 Mazar et al.
7058453 June 2006 Nelson et al.
7203549 April 2007 Schommer et al.
7228182 June 2007 Healy et al.
7237712 July 2007 DeRocco et al.
7384397 June 2008 Zhang et al.
7387010 June 2008 Sunshine et al.
7419573 September 2008 Gundel
7492254 February 2009 Bandy et al.
7565197 July 2009 Haubrich et al.
7574266 August 2009 Dudding et al.
7604178 October 2009 Stewart
7779332 August 2010 Karr et al.
7782192 August 2010 Jeckelmann et al.
7791467 September 2010 Mazar et al.
7860574 December 2010 Von Arx et al.
7882611 February 2011 Shah et al.
7912674 March 2011 Killoren Clark et al.
7916013 March 2011 Stevenson
7955258 June 2011 Goscha et al.
8090445 January 2012 Ginggen
8093991 January 2012 Stevenson et al.
8094009 January 2012 Allen et al.
8098159 January 2012 Batra et al.
8098160 January 2012 Howarth et al.
8098161 January 2012 Lavedas
8098201 January 2012 Choi et al.
8098208 January 2012 Ficker et al.
8102021 January 2012 Degani
8102154 January 2012 Bishop et al.
8102263 January 2012 Yeo et al.
8103241 January 2012 Young et al.
8103325 January 2012 Swedlow et al.
8111042 February 2012 Bennett
8115488 February 2012 McDowell
8120493 February 2012 Burr
8124452 February 2012 Sheats
8130093 March 2012 Mazar et al.
8131351 March 2012 Kalgren et al.
8131365 March 2012 Zhang et al.
8131565 March 2012 Dicks et al.
8132037 March 2012 Fehr et al.
8135352 March 2012 Langsweirdt et al.
8136735 March 2012 Arai et al.
8138925 March 2012 Downie et al.
8140160 March 2012 Pless et al.
8140168 March 2012 Olson et al.
8140299 March 2012 Siess
8150321 April 2012 Winter et al.
8150516 April 2012 Levine et al.
8179266 May 2012 Hermle
2006/0287691 December 2006 Drew
2007/0078818 April 2007 Zvitz et al.
2007/0244383 October 2007 Talbot et al.
2008/0018433 January 2008 Pitt-Pladdy
2008/0021666 January 2008 Goode et al.
2008/0030369 February 2008 Mann et al.
2008/0064943 March 2008 Talbot et al.
2008/0071328 March 2008 Haubrich et al.
2008/0119705 May 2008 Patel et al.
2008/0167572 July 2008 Stivoric et al.
2008/0235469 September 2008 Drew
2008/0255438 October 2008 Saidara et al.
2009/0189738 July 2009 Hermle
2009/0289796 November 2009 Blumberg
2009/0296742 December 2009 Sicurello et al.
2011/0152637 June 2011 Kateraas et al.
2143172 Jul 2005 CA
2396613 Mar 2008 CA
2413148 Aug 2010 CA
0724859 Aug 1996 EP
0678308 May 2000 EP
1292218 Mar 2003 EP
1077634 Jul 2003 EP
1666091 Jun 2006 EP
1703697 Sep 2006 EP
1704893 Sep 2006 EP
1897487 Nov 2009 EP
1897492 Nov 2009 EP
2113864 Nov 2009 EP
1897488 Dec 2009 EP
1681992 Apr 2010 EP
1448489 Aug 2010 EP
1971396 Aug 2010 EP
2201969 Mar 2011 EP
2153382 Feb 2012 EP
2409951 Jul 2005 GB
WO-97/33513 Sep 1997 WO
WO-2005/045744 May 2005 WO
WO-2005/119238 Dec 2005 WO
WO-2006/032653 Mar 2006 WO
WO-2006/124099 Nov 2006 WO
WO-2007/101223 Sep 2007 WO
WO-2007/126444 Nov 2007 WO
WO-2007/053832 Dec 2007 WO
WO-2008/021913 Feb 2008 WO
WO-2008/042760 Apr 2008 WO
WO-2008/128210 Oct 2008 WO
WO-2008/130896 Oct 2008 WO
WO-2008/130897 Oct 2008 WO
WO-2008/130898 Oct 2008 WO
WO-2008/143943 Nov 2008 WO
WO-2009/018058 Feb 2009 WO
WO-2009/086216 Jul 2009 WO
WO-2009/096992 Aug 2009 WO
WO-2009/097594 Aug 2009 WO
WO-2011/022418 Feb 2011 WO
WO-2010/077329 Jul 2012 WO
Aussedat et al. A user-friendly method for calibrating a subcutaneous glucose sensor-based hypoclycaemic alarm Biosensors and Bioelectronics vol. 12, pp. 1061-1071 (1997). cited by examiner .
Garg et al. Improvement in Glycemic Excursions with a Transcutaneous, Real-Time Continuous Glucose Sensor Diabetes Care, vol. 29, pp. 44-50 (Jan. 2006). cited by examiner .
Boyne et al. Timing of Changes in Interstitial and Venous Blood Clucose Measured Wigh a Continuous Subcutaneous Glucose Sensor Diabetes vol. 52, pp. 2790-2794 (2003). cited by examiner .
Armour, J. C., et al., "Application of Chronic Intravascular Blood Glucose Sensor in Dogs",Diabetes, vol. 39, 1990, pp. 1519-1526. cited by applicant .
Blank, T. B., et al., "Clinical Results From a Non-Invasive Blood Glucose Monitor", Optical Diagnostics and Sensing of Biological Fluids and Glucose and Cholesterol Monitoring II, Proceeding of SPIE, vol. 4324, 2002, pp. 1-10. cited by applicant .
Csoregi, E., et al., "Design and Optimization of Selective Subcutaneously Implantable Glucose Electrode Based `Wired` Glucose Oxidase", Analytical Chemistry, vol. 67, No. 7, 1995, pp. 1240-1244. cited by applicant .
El-Khatib, F. H, et al., "Adaptive Closed-Loop Control Provides Blood-Glucose Regulation Using Subcutaneous Insulin and Glucagon Infusion in Diabetic Swine", Journal of Diabetes Science and Technolgy, vol. 1, No. 2, 2007, pp. 181-192. cited by applicant .
Feldman, B., et al., "A Continuous Glucose Sensor Based on Wired Enzyme.TM.--Results from a 3-Day Trial in Patients with Type 1 Diabetes", Diabetes Technology & Therapeutics, vol. 5, No. 5, 2003, pp. 769-779. cited by applicant .
Feldman, B., et al., "Correlation of Glucose Concentrations in Interstitial Fluid and Venous Blood During Periods of Rapid Glucose Change", Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor Pamphet, 2004. cited by applicant .
Roe, J. N., et al., "Bloodless Glucose Measurements", Critical Review in Therapeutic Drug Carrier Systems, vol. 15, Issue 3, 1998, pp. 19-241. cited by applicant .
Shichiri, M., et al., "Telemetry Glucose Monitoring Device With Needle-Type Glucose Sensor: A Useful Tool for Blood Glucose Monitoring in Diabetic Individuals", Diabetes Care, 3, vol. 9, No. 3, 1986, pp. 298-301. cited by applicant .
PCT Application No. PCT/US2008/006247, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Nov. 26, 2009. cited by applicant .
PCT Application No. PCT/US2008/006247, International Search Report and Written Opinion of the International Searching Authority mailed Sep. 5, 2008. cited by applicant .
PCT Application No. PCT/US2008/060277, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Oct. 29, 2009. cited by applicant .
PCT Application No. PCT/US2008/060277, International Search Report and Written Opinion of the International Searching Authority mailed Sep. 22, 2008. cited by applicant .
PCT Application No. PCT/US2008/060279, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Oct. 29, 2009. cited by applicant .
PCT Application No. PCT/US2008/060279, International Search Report and Written Opinion of the International Searching Authority mailed Jul. 14, 2008. cited by applicant .
PCT Application No. PCT/US2008/060281, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Oct. 29, 2009. cited by applicant .
PCT Application No. PCT/US2008/060282, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Oct. 29, 2009. cited by applicant .
PCT Application No. PCT/US2008/060282, International Search Report and Written Opinion of the International Searching Authority mailed Jun. 18, 2009. cited by applicant .
PCT Application No. PCT/US2008/060284, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority mailed Oct. 29, 2009. cited by applicant .
PCT Application No. PCT/US2008/060284, International Search Report and Written Opinion of the International Searching Authority mailed Sep. 23, 2008. cited by applicant .
PCT Application No. PCT/US2008/070923, International Preliminary Report on Patentability and Written Opinion of the International Searching Authority, mailed Feb. 11, 2010. cited by applicant .
PCT Application No. PCT/US2008/070923, International Search Report and Written Opinion of the International Searching Authority mailed Oct. 1, 2008. cited by applicant .
U.S. Appl. No. 11/831,866, Office Action mailed Jun. 25, 2009. cited by applicant .
U.S. Appl. No. 11/831,866, Supplemental Office Action mailed Dec. 9, 2009. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Aug. 5, 2010. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Dec. 14, 2009. cited by applicant .
International Search Report and Written Opinion of the International Searching Authority for PCT Application No. PCT/US2008/060281 filed Apr. 14, 2008 to Abbott Diabetes Care, Inc., mailed Sep. 23, 2008. cited by applicant .
U.S. Appl. No. 11/831,881, Office Action mailed Jun. 21, 2011. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed May 25, 2011. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed Oct. 14, 2011. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Jan. 25, 2011. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Oct. 27, 2011. cited by applicant .
U.S. Appl. No. 12/102,844, Office Action mailed Aug. 17, 2011. cited by applicant .
U.S. Appl. No. 12/102,855, Office Action mailed Aug. 24, 2011. cited by applicant .
U.S. Appl. No. 12/102,856, Office Action mailed Aug. 17, 2011. cited by applicant .
U.S. Appl. No. 12/152,623, Notice of Allowance Mailed Nov. 3, 2011. cited by applicant .
U.S. Appl. No. 12/152,623, Office Action mailed May 26, 2011. cited by applicant .
U.S. Appl. No. 12/152,636, Office Action mailed Dec. 27, 2010. cited by applicant .
U.S. Appl. No. 12/152,636, Office Action mailed Sep. 20, 2011. cited by applicant .
U.S. Appl. No. 12/152,648, Office Action mailed Aug. 12, 2011. cited by applicant .
U.S. Appl. No. 12/152,649, Office Action mailed Aug. 5, 2011. cited by applicant .
U.S. Appl. No. 12/152,650, Office Action mailed Aug. 11, 2011. cited by applicant .
U.S. Appl. No. 12/152,652, Office Action mailed Jun. 23, 2011. cited by applicant .
U.S. Appl. No. 12/152,652, Office Action mailed Nov. 1, 2011. cited by applicant .
U.S. Appl. No. 12/152,657, Office Action mailed Aug. 11, 2011. cited by applicant .
U.S. Appl. No. 12/152,662, Office Action mailed Aug. 19, 2011. cited by applicant .
U.S. Appl. No. 12/152,670, Notice of Allowance mailed Jun. 20, 2011. cited by applicant .
U.S. Appl. No. 12/152,670, Office Action mailed Jan. 7, 2011. cited by applicant .
U.S. Appl. No. 12/152,673 Office Action mailed Aug. 26, 2011. cited by applicant .
European Patent Application No. 08745805.5, Extended European Search Report mailed May 23, 2012. cited by applicant .
U.S. Appl. No. 11/831,881, Office Action mailed Nov. 17, 2011. cited by applicant .
U.S. Appl. No. 11/831,895, Advisory Action mailed Jan. 18, 2012. cited by applicant .
U.S. Appl. No. 11/831,895, Advisory Action mailed Jan. 25, 2012. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed May 25, 2012. cited by applicant .
U.S. Appl. No. 12/102,844, Notice of Allowance mailed Jan. 10, 2012. cited by applicant .
U.S. Appl. No. 12/102,855, Office Action mailed Jan. 10, 2012. cited by applicant .
U.S. Appl. No. 12/102,856, Office Action mailed Jan. 10, 2012. cited by applicant .
U.S. Appl. No. 12/152,636, Advisory Action mailed Jan. 19, 2012. cited by applicant .
U.S. Appl. No. 12/152,636, Advisory Action mailed Jan. 6, 2012. cited by applicant .
U.S. Appl. No. 12/152,636, Notice of Allowance mailed Jun. 19, 2012. cited by applicant .
U.S. Appl. No. 12/152,648, Office Action mailed Jan. 27, 2012. cited by applicant .
U.S. Appl. No. 12/152,649, Office Action mailed Jan. 27, 2012. cited by applicant .
U.S. Appl. No. 12/152,650, Office Action mailed Jan. 26, 2012. cited by applicant .
U.S. Appl. No. 12/152,652, Advisory Action mailed Jan. 13, 2012. cited by applicant .
U.S. Appl. No. 12/152,652, Notice of Allowance mailed May 3, 2012. cited by applicant .
U.S. Appl. No. 12/152,657, Office Action mailed Jan. 26, 2012. cited by applicant .
U.S. Appl. No. 12/152,662, Office Action mailed Jan. 11, 2012. cited by applicant .
U.S. Appl. No. 12/152,673, Office Action mailed Jan. 5, 2012. cited by applicant .
European Patent Application No. 08745807.1, Extended European Search Report mailed Oct. 8, 2012. cited by applicant .
European Patent Application No. 08745803.0, Extended European Search Report mailed Sep. 27, 2012. cited by applicant .
European Patent Application No. 08745809.7, Extended European Search Report mailed Jul. 2, 2012. cited by applicant .
European Patent Application No. 08754499.5, Extended European Search Report mailed Sep. 20, 2012. cited by applicant .
European Patent Application No. 08871628.7 Extended European Search Report mailed Nov. 2, 2012. cited by applicant .
U.S. Appl. No. 11/831,881, Office Action mailed Oct. 1, 2012. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed Jul. 20, 2012. cited by applicant .
U.S. Appl. No. 12/152,648, Office Action mailed Aug. 29, 2012. cited by applicant .
U.S. Appl. No. 12/152,649, Office Action mailed Nov. 5, 2012. cited by applicant .
U.S. Appl. No. 12/152,650, Office Action mailed Jul. 25, 2012. cited by applicant .
U.S. Appl. No. 12/152,673, Office Action mailed Jul. 11, 2012. cited by applicant .
U.S. Appl. No. 13/356,598, Office Action mailed Aug. 30, 2012. cited by applicant .
Li, Y., et al., "In Vivo Release From a Drug Delivery MEMS Device", Journal of Controlled Release, vol. 100, 2004, 99.211-219. cited by applicant .
U.S. Appl. No. 11/831,881, Advisory Action mailed Aug. 23, 2013. cited by applicant .
U.S. Appl. No. 11/831,895, Advisory Action mailed Aug. 5, 2013. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed May 16, 2013. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed Oct. 1, 2013. cited by applicant .
U.S. Appl. No. 12/102,839, Advisory Action mailed May 1, 2013. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Aug. 1, 2013. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Dec. 14, 2012. cited by applicant .
U.S. Appl. No. 12/102,839, Office Action mailed Dec. 5, 2013. cited by applicant .
U.S. Appl. No. 12/102,855, Office Action mailed Jun. 11, 2014. cited by applicant .
U.S. Appl. No. 12/102,856, Office Action mailed May 7, 2014. cited by applicant .
U.S. Appl. No. 12/152,648, Notice of Allowance mailed Aug. 2, 2013. cited by applicant .
U.S. Appl. No. 12/152,648, Office Action mailed Mar. 13, 2013. cited by applicant .
U.S. Appl. No. 12/152,649, Notice of Allowance mailed Jul. 1, 2013. cited by applicant .
U.S. Appl. No. 12/152,650, Notice of Allowance mailed Jan. 22, 2013. cited by applicant .
U.S. Appl. No. 12/152,662, Office Action mailed Jun. 12, 2014. cited by applicant .
U.S. Appl. No. 12/152,673, Advisory Action mailed Apr. 9, 2013. cited by applicant .
U.S. Appl. No. 12/152,673, Office Action mailed Jan. 30, 2013. cited by applicant .
U.S. Appl. No. 13/356,598, Notice of Allowance mailed Jul. 11, 2013. cited by applicant .
U.S. Appl. No. 13/356,598, Office Action mailed May 2, 2013. cited by applicant .
U.S. Appl. No. 13/567,038, Notice of Allowance Nov. 22, 2013. cited by applicant .
U.S. Appl. No. 13/567,038, Office Action mailed Jun. 6, 2013. cited by applicant .
U.S. Appl. No. 13/567,038, Office Action mailed Oct. 10, 2013. cited by applicant .
U.S. Appl. No. 13/599,847, Notice of Allowance mailed Aug. 21, 2013. cited by applicant .
U.S. Appl. No. 13/599,847, Office Action mailed Jan. 29, 2013. cited by applicant .
Arnold, M. A., et al., "Selectivity Assessment of Noninvasive Glucose Measurements Based on Analysis of Mulivariate Calibration Vectors", Journal of Diabetes Science and Technology, vol. 1, No. 4, 2007, pp. 454-462. cited by applicant .
Canadian Patent Application No. 2,683,930, Examiner's Report mailed Jul. 22, 2014. cited by applicant .
U.S. Appl. No. 11/831,881, Notice of Allowance mailed Jun. 20, 2014. cited by applicant .
U.S. Appl. No. 11/831,881, Office Action mailed Mar. 13, 2014. cited by applicant .
U.S. Appl. No. 11/831,881, Office Action mailed May 23, 2013. cited by applicant .
U.S. Appl. No. 11/831,895, Office Action mailed Jul. 17, 2014. cited by applicant .
U.S. Appl. No. 12/102,855, Office Action mailed Oct. 24, 2014. cited by applicant .
U.S. Appl. No. 12/102,856, Office Action mailed Nov. 25, 2014. cited by applicant .
U.S. Appl. No. 12/152,657, Office Action mailed Sep. 18, 2014. cited by applicant .
U.S. Appl. No. 12/152,662, Advisory Action mailed Sep. 3, 2014. cited by applicant .
U.S. Appl. No. 14/106,000, Office Action mailed Aug. 26, 2014. cited by applicant .
U.S. Appl. No. 14/106,000, Office Action mailed Jun. 17, 2014. cited by applicant .
U.S. Appl. No. 14/106,000, Office Action mailed Nov. 26, 2014. cited by applicant.
The present application claims priority under .sctn.35 U.S.C. 119(e) to U.S. provisional application No. 60/911,872 filed Apr. 14, 2007, entitled "Method and Apparatus for Providing Data Processing and Control in Medical Communication System", and assigned to the Assignee of the present application, Abbott Diabetes Care Inc. of Alameda, Calif., the disclosure of which is incorporated herein by reference for all purposes.
1. A method, comprising: generating with an analyte sensor a plurality of signals, wherein the plurality of signals have a signal characteristic independent of a measured analyte level of a user; determining, using an analyte monitoring device electrically coupled to the analyte sensor and in signal communication with the analyte sensor, whether the signal characteristic of the plurality of generated signals deviates from a predetermined signal characteristic corresponding to signal characteristics of a predetermined operational state of the analyte monitoring device, wherein the predetermined operational state corresponds to an individual one of a plurality of operational states of the analyte monitoring device, wherein each of the plurality of operational states have a corresponding signal characteristic, wherein the plurality of operational states includes an analyte sensor removal state and an analyte sensor insertion state; setting a present operational state of the analyte monitoring device based on the signal characteristic of the plurality of generated signals, wherein if the signal characteristic of the plurality of generated signals deviate from the predetermined signal characteristic corresponding to the predetermined operational state the present operational state will differ from the predetermined operational state; presenting an output data associated with an operational state of the analyte monitoring device and based at least in part on an analysis of one or more of the plurality of generated signals relative to a prior generated signal; and determining a new operational state of the analyte monitoring device based upon user input in response to the output data.
2. The method of claim 1, wherein the predetermined signal characteristic further includes one or more of a signal level transition from below a first predetermined level to above the first predetermined level, a signal level transition from above a second predetermined level to below the second predetermined level, a transition from below a predetermined signal rate of change threshold to above the predetermined signal rate of change threshold, or a transition from above the predetermined signal rate of change threshold to below the predetermined signal rate of change threshold.
3. The method of claim 2, wherein the first predetermined level and the second predetermined level each includes one of approximately 9 ADC counts or approximately 18 ADC counts.
4. The method of claim 1, wherein the predetermined signal characteristic includes a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time.
5. The method of claim 4, wherein the predetermined period of time includes one of approximately 10 seconds, 30 seconds, less than 30 seconds, or greater than 30 seconds.
6. The method of claim 1, wherein the output data includes a user notification alert.
7. The method of claim 1, wherein the output data includes an indicator to start one or more processing timers associated with a respective one or more data processing routines.
8. The method of claim 7, wherein the one or more processing timers includes a respective one of a calibration timer, or a sensor expiration timer.
9. The method of claim 1, wherein the user input data includes a user confirmation of a transition to the new operational state.
10. The method of claim 1, including transitioning from the present operational state to the new operational state.
11. The method of claim 10, wherein the transitioning from the present operational state to the new operational state is based on the received user input data, or based on the generated output data.
12. The method of claim 1, wherein presenting the output data includes one or more of visually presenting the output data, audibly presenting the output data, vibratorily presenting the output data, or one or more combinations thereof.
13. The method of claim 1, wherein the analyte level includes glucose level of a user.
14. The method of claim 1, wherein the new operational state includes one of an analyte sensor removal state, an analyte sensor insertion state, an analyte sensor dislocation state, an analyte sensor insertion with an associated transient signal state, or an analyte sensor insertion with an associated stabilized signal state.
15. A data processing device, comprising: a storage unit; a user interface unit; and a data processor operatively coupled to the user interface unit and the storage unit, the data processor configured to: receive a plurality of signals generated by an analyte sensor, wherein the plurality of signals have a signal characteristic independent of a measured analyte level of a user, the analyte sensor in signal communication with the data processor; determine whether the signal characteristic of the plurality of generated signals deviates from a predetermined signal characteristic corresponding to signal characteristics of a predetermined operational state of the analyte monitoring device, wherein the predetermined operational state of the analyte monitoring device corresponds to an individual one of a plurality of operational states of the analyte monitoring device, wherein each of the plurality of operational states have a corresponding signal characteristic, wherein the plurality of operational states includes an analyte sensor removal state and an analyte sensor insertion state; set a present operational state of the analyte monitoring device based on the signal characteristic of the plurality of generated signals, wherein if the signal characteristic of the plurality of generated signals deviate from the predetermined signal characteristic corresponding to the predetermined operational state the present operational state will differ from the predetermined operational state; present in the user interface unit an output data associated with an operational state of the analyte monitoring device and based at least in part on an analysis of one or more of the plurality of generated signals relative to a prior generated signal; and determine a new operational state associated with an analyte monitoring device based upon user input in response to the output data.
16. The device of claim 15, wherein the user interface unit includes one or more of a user input unit, a visual display unit, an audible output unit, a vibratory output unit, or a touch sensitive user input unit.
17. The device of claim 16, including a communication unit operatively coupled to the data processor and configured to communicate one or more of the received signal, the prior signal, and the output data.
18. The device of claim 17, wherein the communication unit includes one of an RF transmitter, an RF receiver, an infrared data communication device, or a short-range data communication device.
19. The device of claim 16, including a storage unit operatively coupled to the data processor to store one or more of the received signal associated with the analyte level, the predetermined signal characteristic, the prior signal, the output data, and the new operational state associated with the analyte monitoring device.
20. The method of claim 1, including transitioning from the present operational state to the new operational state associated with the analyte monitoring device, and executing one or more routines associated with the new operational state.
21. The device of claim 15, wherein the data processor is further configured to transition from the present operational state to the new operational state associated with the analyte monitoring device, and execute one or more routines associated with the new operational state.
22. The method of claim 4, wherein the predetermined time period is 90 seconds or less.
23. The method of claim 1, wherein the predetermined signal characteristic comprises a predetermined analog to digital conversion (ADC) count, wherein the predetermined ADC count includes 9 ADC counts over a predetermined time period.
24. The device of claim 15, wherein the predetermined signal characteristic includes a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time, wherein the predetermined time period is 90 seconds or less.
25. The device of claim 15, wherein the predetermined signal characteristic comprises a predetermined analog to digital conversion (ADC) count, wherein the predetermined ADC count includes 9 ADC counts over a predetermined time period.
26. The method of claim 1, wherein the plurality of operational states further includes a new analyte sensor insertion state.
27. The device of claim 15, wherein the plurality of operational states further includes a new analyte sensor insertion state.
In one embodiment, method and apparatus for receiving a signal associated with an analyte level of a user, determining whether the received signal deviates from a predetermined signal characteristic, determining an operational state associated with an analyte monitoring device, comparing a prior signal associated with the analyte level of the user to the received signal, presenting an output data associated with the operational state of the analyte monitoring device based, at least in part, on one or more of the received signal or the prior signal, and receiving a user input data based on the presented output data, is disclosed.
As described in further detail below, in accordance with the various embodiments of the present invention, there is provided a method and apparatus for providing data processing and control for use in a medical telemetry system. In particular, within the scope of the present invention, there is provided a method and system for providing data communication and control for use in a medical telemetry system such as, for example, a continuous glucose monitoring system.
In this embodiment, the data processing terminal 105 which may include an insulin pump, may be configured to receive the analyte signals from the transmitter unit 102, and thus, incorporate the functions of the receiver 104 including data processing for managing the patient's insulin therapy and analyte monitoring. In one embodiment, the communication link 103 may include one or more of an RF communication protocol, an infrared communication protocol, a Bluetooth.RTM. enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPAA requirements) while avoiding potential data collision and interference.
As can be seen from FIG. 2, the sensor 101 (FIG. 1) is provided four contacts, three of which are electrodes--work electrode (W) 210, guard contact (G) 211, reference electrode (R) 212, and counter electrode (C) 213, each operatively coupled to the analog interface 201 of the transmitter unit 102. In one embodiment, each of the work electrode (W) 210, guard contact (G) 211, reference electrode (R) 212, and counter electrode (C) 213 may be made using a conductive material that is either printed or etched, for example, such as carbon which may be printed, or metal foil (e.g., gold) which may be etched, or alternatively provided on a substrate material using laser or photolithography.
The transmitter unit 102 is also configured such that the power supply section 207 is capable of providing power to the transmitter for a minimum of about three months of continuous operation after having been stored for about eighteen months in a low-power (non-operating) mode. In one embodiment, this may be achieved by the transmitter processor 204 operating in low power modes in the non-operating state, for example, drawing no more than approximately 1 .mu.A of current. Indeed, in one embodiment, the final step during the manufacturing process of the transmitter unit 102 may place the transmitter unit 102 in the lower power, non-operating state (i.e., post-manufacture sleep mode). In this manner, the shelf life of the transmitter unit 102 may be significantly improved. Moreover, as shown in FIG. 2, while the power supply unit 207 is shown as coupled to the processor 204, and as such, the processor 204 is configured to provide control of the power supply unit 207, it should be noted that within the scope of the present invention, the power supply unit 207 is configured to provide the necessary power to each of the components of the transmitter unit 102 shown in FIG. 2.
Additional detailed description of the continuous analyte monitoring system, its various components including the functional descriptions of the transmitter are provided in U.S. Pat. No. 6,175,752 issued Jan. 16, 2001 entitled "Analyte Monitoring Device and Methods of Use", and in application Ser. No. 10/745,878 filed Dec. 26, 2003, now U.S. Pat. No. 7,811,231, entitled "Continuous Glucose Monitoring System and Methods of Use", each assigned to the Assignee of the present application.
In one aspect, the temperature measurement section 203 of the transmitter unit 102 may be configured to measure once per minute the on skin temperature near the analyte sensor at the end of the minute sampling cycle of the sensor signal. Within the scope of the present disclosure, different sample rates may be used which may include, for example, but are not limited to, measuring the on skin temperature for each 30 second periods, each two minute periods, and the like. Additionally, as discussed above, the transmitter unit 102 may be configured to detect sensor insertion, sensor signal settling after sensor insertion, and sensor removal, in addition to detecting for sensor--transmitter system failure modes and sensor signal data integrity. Again, this information is transmitted periodically by the transmitter unit 102 to the receiver unit 104 along with the sampled sensor signals at the predetermined time intervals.
Referring again to the Figures, as the analyte sensor measurements are affected by the temperature of the tissue around the transcutaneously positioned sensor 101, in one aspect, compensation of the temperature variations and affects on the sensor signals are provided for determining the corresponding glucose value. Moreover, the ambient temperature around the sensor 101 may affect the accuracy of the on skin temperature measurement and ultimately the glucose value determined from the sensor signals. Accordingly, in one aspect, a second temperature sensor is provided in the transmitter unit 102 away from the on skin temperature sensor (for example, physically away from the temperature measurement section 203 of the transmitter unit 102), so as to provide compensation or correction of the on skin temperature measurements due to the ambient temperature effects. In this manner, the accuracy of the estimated glucose value corresponding to the sensor signals may be attained.
Referring now to FIG. 5, in one aspect, is an ambient temperature compensation routine for determining the on-skin temperature level for use in the glucose estimation determination based on the signals received from the sensor 101. Referring to FIG. 5, for each sampled signal from the sensor 101, a corresponding measured temperature information is received (510), for example, by the processor 204 from the temperature measurement section 203 (which may include, for example, a thermistor provided in the transmitter unit 102). In addition, a second temperature measurement is obtained (520), for example, including a determination of the ambient temperature level using a second temperature sensor provided within the housing of the transmitter unit 102.
In one aspect, based on a predetermined ratio of thermal resistances between the temperature measurement section 203 and the second temperature sensor (located, for example, within the processor 204 of the transmitter unit 102), and between the temperature measurement section 203 and the skin layer on which the transmitter unit 102 is placed and coupled to the sensor 101, ambient temperature compensation may be performed (530), to determine the corresponding ambient temperature compensated on skin temperature level (540). In one embodiment, the predetermined ratio of the thermal resistances may be approximately 0.2. However, within the scope of the present invention, this thermal resistance ratio may vary according to the design of the system, for example, based on the size of the transmitter unit 102 housing, the location of the second temperature sensor within the housing of the transmitter unit 102, and the like.
Referring to FIG. 6, a routine for digital anti-aliasing filtering is shown in accordance with one embodiment. As shown, in one embodiment, at each predetermined time period such as every minute, the analog signal from the analog interface 201 corresponding to the monitored analyte level received from the sensor 101 (FIG. 1) is sampled (610). For example, at every minute, in one embodiment, the signal from the analog interface 201 is over-sampled at approximately 4 Hz. Thereafter, the first stage digital filtering on the over-sampled data is performed (620), where, for example, a 1/6 down-sampling from 246 samples to 41 samples is performed, and the resulting 41 samples is further down-sampled at the second stage digital filtering (630) such that, for example, a 1/41 down-sampling is performed from 41 samples (from the first stage digital filtering), to a single sample. Thereafter, the filter is reset (640), and the routine returns to the beginning for the next minute signal received from the analog interface 201.
That is, when the transmitter unit 102 detects low or no signal from the sensor 101, which is followed by detected signals from the sensor 101 that is above a given signal, the processor 204 may be configured to identify such transition as monitored signal levels and associate with a potential sensor insertion state. Alternatively, the transmitter unit 102 may be configured to detect the signal level above the other predetermined threshold level, which is followed by the detection of the signal level from the sensor 101 that falls below the same or another predetermined threshold level. In such a case, the processor 204 may be configured to associate or identify such transition or condition in the monitored signal levels as a potential sensor removal state.
In another aspect, the sensor insertion state or potential sensor removal state may be detected or determined by the receiver unit based on one or more signals from the transmitter unit 102 and one or more signals derived at the receiver unit 104. For example, similar to an alarm condition or a notification to the user, the receiver unit 104 may be configured to display a request or a prompt on the display or an output unit of the receiver unit 104 a text and/or other suitable notification message to inform the user to confirm the state of the sensor 101.
For example, the receiver unit 104 may be configured to display the following message: "New Sensor Inserted" or "Did you insert a new Sensor??" or a similar notification in the case where the receiver unit 104 receives one or more signals from the transmitter unit 102 associated with the detection of the signal level below the predetermined threshold level for the predefined period of time, followed by the detection of the signal level from the sensor 101 above another predetermined threshold level for another predefined period of time. Alternatively, the receiver unit may display this message when it receives the "new sensor" or "sensor inserted" operational state data from the transmitter, that has changed from the previous operational state data, stored in the receiver unit, indicating "sensor removed". Indeed, in one aspect, the receiver unit may be configured to maintain a state machine, and if it is in the "sensor removed" state, the receiver is configured to look for "new sensor" or "sensor stable" transitions to determine if it needs to change state.
Additionally, the receiver unit 104 may be configured to display the following message: "Sensor removed" or "Did you remove the sensor?" or a similar notification in the case where the receiver unit 104 received one or more signals from the transmitter unit 102 associated with the detection of the signal level from the sensor 101 that is above the other predetermined threshold level for the other predefined period of time, which is followed by the detection of the signal level from the sensor 101 that falls below the predetermined threshold level for the predefined period of time. Again, in another embodiment, the receiver unit may display this message when it receives the "sensor removed" operational state data from the transmitter, that has changed from the previous operational state data, stored in the receiver unit, indicating "new sensor" or "sensor inserted".
In this manner, in cases, for example, when there is momentary movement or temporary dislodging of the sensor 101 from the initially positioned transcutaneous state, or when one or more of the contact points between sensor 101 and the transmitter unit 102 are temporarily disconnected, but otherwise, the sensor 101 is operational and within its useful life, the routine above provides an option to the user to maintain the usage of the sensor 101, to not replace the sensor 101 prior to the expiration of its useful life. In this manner, in one aspect, false positive indications of sensor 101 failure may be identified and addressed.
For example, FIG. 7 is a flowchart illustrating an actual or potential sensor insertion or removal detection routine in accordance with one embodiment of the present invention. Referring to the Figure, the state machine is in an initial operational state, for instance, the "sensor removed" state. Next, the current analyte related signal is received and then compared to one or more predetermined signal characteristics. One predetermined signal characteristic, associated with new sensor insertion, is for the signal level to exceed 18 ADC (analog to digital conversion) counts continuously for approximately 10 seconds. Another predetermined signal characteristic, associated with signal settling (that is, the signal transient associated with sensor insertion has subsided), is for the signal level to exceed 9 ADC counts and the result of the current signal minus a previous signal from 10 seconds prior, retrieved from storage, must be less than 59 ADC counts, both continuously for a duration of 90 seconds.
Referring back to the Figure, a new operational state is determined. In one aspect this is based on the present operational state, and the results from the signal being compared with predetermined signal characteristics. For example, if the present operational state is "sensor removed", and the result of the predetermined signal characteristic comparison associated with new sensor insertion is true, then the operational state will transition to the "new sensor" state. Likewise, if the present operational state is "sensor inserted" or "new sensor", and the result of the predetermined signal characteristic comparison associated with sensor removal is true, then the operational state will transition to the "sensor removed" state. If the comparison results are false, then the operational state stays unchanged. Similarly, other state transition operations can be contemplated and implemented as required.
In this manner, in one aspect of the present invention, based on a transition state of the received analyte related signals, it may be possible to determine the state of the analyte sensor and, based on which, the user or the patient to confirm, whether the analyte sensor is in the desired or proper position, has been temporarily dislocated, or otherwise removed from the desired insertion site so as to require a new analyte sensor.
FIG. 8 is a flowchart illustrating receiver unit processing corresponding to the actual or potential sensor insertion or removal detection routine of FIG. 7 in accordance with one embodiment of the present invention. Referring now to FIG. 8, when the receiver unit 104 receives the generated output data from the transmitter unit 102 (810), it is related to a corresponding operation state such as a potential new operational state of the sensor 101 (820). Moreover, if the potential new operational state is different than the current operational state, a notification associated with the sensor operation state is generated and output to the user on the display unit or any other suitable output segment of the receiver unit 104 (830). When a user input signal is received in response to the notification associated with the sensor state operation state (840), the receiver unit 104 is configured to execute one or more routines associated with the received user input signal (850).
FIG. 9 is a flowchart illustrating data processing corresponding to the actual or potential sensor insertion or removal detection routine in accordance with another embodiment of the present invention. Referring to FIG. 9, a current analyte related signal is received from the transmitter unit and compared to a predetermined signal characteristic (910). Thereafter, a new potential operational state associated with an analyte monitoring device such as, for example, the sensor 101 (FIG. 1) is retrieved (920) from a storage unit or otherwise resident in, for example, a memory of the receiver/monitor unit. Additionally, a prior analyte related signal is also retrieved from the storage unit, and compared to the current analyte related signal received (930). An output data is generated which is associated with the operational state, and which, at least in part, is based on the one or more of the received current analyte related signal and the retrieved prior analyte related signal.
Referring again to FIG. 9, when the new potential operational state is generated, a corresponding user input command or signal is received (950) in response to the generated output data (940), which may include one or more of a confirmation, verification, or rejection of the operational state related to the analyte monitoring device.
Within the scope of the present invention, the ongoing routine or the predetermined routine being executed may include one or more of performing a finger stick blood glucose test (for example, for purposes of periodically calibrating the sensor 101), or any other processes that interface with the user interface, for example, on the receiver/monitor unit 104/106 (FIG. 1) including, but not limited to the configuration of device settings, review of historical data such as glucose data, alarms, events, entries in the data log, visual displays of data including graphs, lists, and plots, data communication management including RF communication administration, data transfer to the data processing terminal 105 (FIG. 1), or viewing one or more alarm conditions with a different priority in a preprogrammed or determined alarm or notification hierarchy structure.
An apparatus in a further embodiment may include a housing, an analyte sensor coupled to the housing and transcutaneously positioned under a skin layer of a user, a first temperature detection unit coupled to the housing configured to detect a temperature associated with the analyte sensor, and a second temperature detection unit provided in the housing and configured to detect an ambient temperature.
Alternatively, the predetermined value in still another aspect may be variable based on an error feedback signal associated with the monitored analyte level by the analyte sensor, where the error feedback signal may be associated with a difference between a blood glucose reference value and the analyte sensor signal.
The first and the second filter stages may include respective first and second down sampling filter characteristics.
The predetermined time interval in one aspect may include one of approximately 30 seconds, approximately one minute, approximately two minutes, approximately five minutes, or any other suitable time periods.
The received sampled signal in one aspect may be periodically received at a predetermined time interval, where the predetermined time interval may include one of approximately 30 seconds, approximately one minute, approximately two minutes, or approximately five minutes.
The predetermined signal characteristic may include in one aspect, a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time, where the predetermined period of time may include one of approximately 10 seconds, 30 seconds, or less than 30 seconds, or greater than 30 seconds, or any other suitable time periods.
The communication unit may include one of an RF transmitter, an RF receiver, an infrared data communication device, a Bluetooth.RTM. data communication device, or a Zigbee.RTM. data communication device.
A method in accordance with still yet a further embodiment may include receiving a signal associated with an analyte level of a user, determining whether the received signal deviates from a predetermined signal characteristic, determining an operational state associated with an analyte monitoring device, comparing a prior signal associated with the analyte level of the user to the received signal, presenting an output data associated with the operational state of the analyte monitoring device based, at least in part, on one or more of the received signal or the prior signal, and receiving a user input data based on the presented output data.
The predetermined signal characteristic in another aspect may include a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time which may include, for example, but is not limited to, approximately 10 seconds, 30 seconds, or less than 30 seconds, or greater than 30 seconds.
A data processing device in accordance with one embodiment may include a user interface unit, and a data processor operatively coupled to the user interface unit, the data processor configured to receive a signal associated with an analyte level of a user, determine whether the received signal deviates from a predetermined signal characteristic, determine an operational state associated with an analyte monitoring device, compare a prior signal associated with the analyte level of the user to the received signal, present in the user interface unit an output data associated with the operational state of the analyte monitoring device based, at least in part, on one or more of the received signal or the prior signal, and to receive a user input data from the user interface unit based on the presented output data.
In one embodiment, the device may include a communication unit operatively coupled to the data processor and configured to communicate one or more of the received signal, the prior signal, and the output data associated with the operational state of the analyte monitoring device, where the communication unit may include, for example, but is not limited to, one of an RF transmitter, an RF receiver, an infrared data communication device, a Bluetooth.RTM. data communication device, a Zigbee.RTM. data communication device, or a wired connection.
Moreover, in one aspect, the first indication may include one or more of visual, audible, or vibratory indicators.
Further, the second indication may include one or more of visual, audible, or vibratory indicators.
In one aspect, the first indication may include a temporary indicator, and further, and the second indication may include a predetermined alarm associated with a detected predefined alarm condition.
The first indication or the second indication or both, in one aspect may include one or more of visual, audible, or vibratory indicators output on the user interface.
In addition, the first indication may include a temporary indicator, and further, wherein the second indication includes a predetermined alarm associated with the detected predefined alarm condition.
Previous Patent US 9,615,779 | Next Patent US 9,615,781