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US6175752B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Analyte monitoring device and methods of use

Assignee: Abbott Diabetes Care Inc
•
Filing: 1998-04-30
•
Granted: 2001-01-16
•
Expires: 2018-04-30
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Abstract

Abstract An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Inventors

  • 👤 James Say
  • 👤 Michael F. Tomasco
  • 👤 Adam Heller
  • 👤 Yoram Gal
  • 👤 Behrad Aria
  • 👤 Ephraim Heller
  • 👤 Phillip John Plante
  • 👤 Mark S. Vreeke
  • 👤 Keith A. Friedman
  • 👤 Fredric C. Colman

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-29 08:38
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/14532; A61B5/01; A61B5/14503; A61B5/14507; A61B5/1451; A61B5/14546; A61B5/1468; A61B5/1486; A61B5/14865; A61B5/1495; A61B5/48; A61B5/4836; A61B5/4839; A61B5/72; A61B5/7271; A61B5/7278; A61B5/7282; A61B5/74; A61B5/7405; A61B5/742; A61B5/743; A61B5/7445; A61B5/7455; A61M; A61M5/00; A61M5/14; A61M5/168; A61M5/172; A61M5/1723; C; C12; C12Q; C12Q1/00; C12Q1/54; G; G16; G16H; G16H10/00; G16H10/40; G16H20/00; G16H20/10; G16H20/17; H; H10; H10W; H10W70/00; H10W70/40; H10W70/421; H10W70/424; H10W74/00; H10W74/10; H10W74/111; A61B2560/00; A61B2560/02; A61B2560/0242; A61B2560/0247; A61B2560/0252; A61B5/0002; A61B5/0015; A61B5/002; A61B5/1473; Y; Y10; Y10S; Y10S128/00; Y10S128/903; Y10T; Y10T29/00; Y10T29/49; Y10T29/49002; Y10T29/49117; Y10T29/49124

Claims Analysis

Total Claims: 99
Claim 1
Independent Claim 80 words
A sensor control unit comprising: a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads; a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.
Claim 2
Dependent Claim 80 words
A sensor control unit comprising: a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads; a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.
Claim 3
Dependent Claim 19 words
The sensor control unit of claim 1 , further comprising adhesive for adhering the sensor control unit to skin.
Claim 4
Dependent Claim 19 words
The sensor control unit of claim 1 , further comprising a mounting unit adapted for coupling with the housing.
Claim 5
Dependent Claim 25 words
The sensor control unit of claim 3 , wherein the mounting unit is configured for placement between the housing and the skin of the patient.
Claim 6
Dependent Claim 32 words
The sensor control unit of claim 3 , wherein adhesive is disposed on a surface of the mounting unit for adhering the mounting unit and housing to the skin of the patient.
Claim 7
Dependent Claim 35 words
The sensor control unit of claim 3 , further comprising a support structure disposed on the mounting unit for aligning the contact pads of the sensor with the conductive contacts of the sensor control unit.
Claim 8
Dependent Claim 27 words
The sensor control unit of claim 3 , further comprising an opening in the mounting unit configured for guiding insertion of the electrochemical sensor into the patient.
Claim 9
Dependent Claim 17 words
The sensor control unit of claim 1 , wherein the housing comprises a base and a cover.
Claim 10
Dependent Claim 23 words
The sensor control unit of claim 8 , wherein the base and cover are configured to form a water resistant seal when coupled.
Claim 11
Dependent Claim 14 words
The sensor control unit of claim 1 , wherein the housing is water resistant.
Claim 12
Dependent Claim 21 words
The sensor control unit of claim 1 , wherein the conductive contacts are disposed on an interior surface of the housing.
Claim 13
Dependent Claim 20 words
The sensor control unit of claim 11 , wherein the housing comprises a port adapted for penetration by the sensor.
Claim 14
Dependent Claim 23 words
The sensor control unit of claim 1 , wherein the plurality of conductive contacts are disposed on an exterior surface of the housing.
Claim 15
Dependent Claim 21 words
The sensor control unit of claim 1 , wherein a volume of the housing is about 10 cm 3 or less.
Claim 16
Dependent Claim 20 words
The sensor control unit of claim 1 , wherein a height of the housing is about 0.7 cm or less.
Claim 17
Dependent Claim 20 words
The sensor control unit of claim 1 , wherein a weight of the housing is about 90 grams or less.
Claim 18
Dependent Claim 16 words
The sensor control unit of claim 1 , further comprising a battery disposed in the housing.
Claim 19
Dependent Claim 21 words
The sensor control unit of claim 17 , wherein the battery is sealed within the housing of the sensor control unit.
Claim 20
Dependent Claim 16 words
The sensor control unit of claim 17 , wherein the battery is removable from the housing.
Claim 21
Dependent Claim 25 words
The sensor control unit of claim 1 , further comprising an alarm to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.
Claim 22
Dependent Claim 16 words
The sensor control unit of claim 20 , further comprising a switch for deactivating the alarm.
Claim 23
Dependent Claim 17 words
The sensor control unit of claim 20 , wherein the alarm produces an audible signal when activated.
Claim 24
Dependent Claim 22 words
The sensor control unit of claim 22 , wherein a loudness of the alarm increases over time when the alarm is activated.
Claim 25
Dependent Claim 16 words
The sensor control unit of claim 20 , wherein the alarm produces a vibration when activated.
Claim 26
Dependent Claim 26 words
The sensor control unit of claim 20 , wherein the alarm is configured to indicate at least two of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.
Claim 27
Dependent Claim 16 words
The sensor control unit of claim 1 , further comprising a receiver disposed in the housing.
Claim 28
Dependent Claim 42 words
The sensor control unit of claim 1 , further comprising a processing circuit disposed in the housing and coupled to the conductive contacts, the processing circuit is configured for determining a level of an analyte from a signal generated by the sensor.
Claim 29
Dependent Claim 33 words
The sensor control unit of claim 27 , wherein the processing circuit is configured for determining the level of the analyte in blood from a sensor that is subcutaneously implanted in the patient.
Claim 30
Dependent Claim 30 words
The sensor control unit of claim 27 , wherein the processing circuit is configured for adjusting the data for temperature using a signal from a temperature probe of the sensor.
Claim 31
Dependent Claim 22 words
The sensor control unit of claim 1 , wherein the plurality of conductive contacts of the sensor control unit comprise conductive carbon.
Claim 32
Dependent Claim 26 words
The sensor control unit of claim 1 , further comprising a data storage unit disposed in the housing for keeping data for a period of time.
Claim 33
Dependent Claim 103 words
A sensor assembly, comprising: a sensor having a substrate, at least one recessed channel formed in a surface of the substrate, conductive material disposed in the at least one recessed channel to form at least one working electrode and an individual contact pad for each of the at least one working electrodes; and a sensor control unit for placement on a skin of an animal, the sensor control unit including a housing having a port through which the sensor penetrates the housing, and a plurality of conductive contacts disposed in the housing and configured for coupling with the contact pads of the sensor.
Claim 34
Dependent Claim 103 words
A sensor assembly, comprising: a sensor having a substrate, at least one recessed channel formed in a surface of the substrate, conductive material disposed in the at least one recessed channel to form at least one working electrode and an individual contact pad for each of the at least one working electrodes; and a sensor control unit for placement on a skin of an animal, the sensor control unit including a housing having a port through which the sensor penetrates the housing, and a plurality of conductive contacts disposed in the housing and configured for coupling with the contact pads of the sensor.
Claim 35
Dependent Claim 112 words
A sensor assembly, comprising: a sensor comprising a flexible substrate with at least one working electrode, at least one counter electrode, and at least one contact pad coupled to each of the working and counter electrodes, the sensor being adapted for implantation of a portion of the sensor comprising the working and counter electrodes through skin; and a sensor control unit comprising a housing adapted for placement on skin; a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the sensor; and an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.
Claim 36
Dependent Claim 112 words
A sensor assembly, comprising: a sensor comprising a flexible substrate with at least one working electrode, at least one counter electrode, and at least one contact pad coupled to each of the working and counter electrodes, the sensor being adapted for implantation of a portion of the sensor comprising the working and counter electrodes through skin; and a sensor control unit comprising a housing adapted for placement on skin; a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the sensor; and an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.
Claim 37
Dependent Claim 35 words
A sensor assembly, comprising: a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode; and the sensor control unit of claim 1 .
Claim 38
Dependent Claim 23 words
The sensor assembly of claim 34 , wherein the plurality of conductive contacts, the plurality of contact pads, or both comprise conductive carbon.
Claim 39
Dependent Claim 58 words
The sensor assembly of claim 35 , wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 1 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.
Claim 40
Dependent Claim 58 words
The sensor assembly of claim 35 , wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 100 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.
Claim 41
Dependent Claim 18 words
The sensor assembly of claim 34 , further comprising a mounting unit adapted for coupling with the housing.
Claim 42
Dependent Claim 87 words
An analyte monitoring system comprising: a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin; the sensor control unit of claim 1 ; and a display unit comprising an rf receiver for receiving data from the sensor control unit, and a display coupled to the rf receiver for displaying an indication of the level of an analyte.
Claim 43
Dependent Claim 19 words
The analyte monitoring system of claim 39 , further comprising a mounting unit adapted for coupling with the housing.
Claim 44
Dependent Claim 42 words
The analyte monitoring system of claim 39 , wherein the sensor control unit further comprises an rf receiver disposed in the housing and the display unit further comprises an rf transmitter for transmitting to the rf receiver of the sensor control unit.
Claim 45
Dependent Claim 38 words
The analyte monitoring system of claim 39 , wherein the display unit further comprises an analyzer coupled to the display and the rf receiver for analyzing data from the rf receiver and providing analyzed data to the display.
Claim 46
Dependent Claim 22 words
The analyte monitoring system of claim 39 , wherein the display unit further comprises a battery coupled to the receiver and display.
Claim 47
Dependent Claim 21 words
The analyte monitoring system of claim 39 , wherein the display unit further comprises an input device coupled to the display.
Claim 48
Dependent Claim 30 words
The analyte monitoring system of claim 39 , further comprising a calibrator for providing a calibration value to at least one of the display unit and the sensor control unit.
Claim 49
Dependent Claim 30 words
The analyte monitoring system of claim 45 , wherein the calibrator is coupled to the receiver of the display unit for providing the calibration value to the sensor control unit.
Claim 50
Dependent Claim 23 words
The analyte monitoring system of claim 45 , wherein the calibrator provides a calibration value using 1 microliter or less of body fluid.
Claim 51
Dependent Claim 21 words
The analyte monitoring system of claim 45 , wherein the calibrator comprises a device configured for non-invasive optical assay of analyte.
Claim 52
Dependent Claim 14 words
The analyte monitoring system of claim 39 , wherein the display unit is portable.
Claim 53
Dependent Claim 21 words
The analyte monitoring system of claim 49 , wherein the display unit is configured for wearing on a piece of clothing.
Claim 54
Dependent Claim 47 words
The analyte monitoring system of claim 49 , further comprising a secondary display unit having a power cord for connecting to an electrical outlet, a receiver for receiving data transmitted by the transmitter, and a display coupled to the receiver for displaying the level of the analyte.
Claim 55
Dependent Claim 22 words
The analyte monitoring system of claim 51 , wherein the display unit and the secondary display unit are configured for exchanging data.
Claim 56
Dependent Claim 20 words
The analyte monitoring system of claim 39 , wherein the display unit is configured for connection to an electrical outlet.
Claim 57
Dependent Claim 40 words
The analyte monitoring system of claim 53 , wherein the display unit further comprises at least one of a lamp, a radio, a clock, an interface to a telephone system, an interface to a computer, or a battery backup system.
Claim 58
Dependent Claim 38 words
The analyte monitoring system of claim 39 , wherein the display unit further comprises an alarm configured for activation if a signal from the transmitter of the sensor control unit is not received with a predetermined time interval.
Claim 59
Dependent Claim 24 words
The analyte monitoring system of claim 39 , wherein the display unit comprises a pager receiver for receiving pages from an external paging system.
Claim 60
Dependent Claim 44 words
The analyte monitoring system of claim 56 , wherein the display unit comprises a pager transmitter for sending pages to the external paging system, wherein the pager transmitter is activated when at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia is indicated.
Claim 61
Dependent Claim 28 words
The analyte monitoring system of claim 39 , wherein the display unit is configured for coupling to an external download device to transfer data from the display unit.
Claim 62
Dependent Claim 33 words
The analyte monitoring system of claim 39 , further comprising at least one alarm disposed in the display unit and configured to indicate when a level of an analyte exceeds a threshold level.
Claim 63
Dependent Claim 26 words
The analyte monitoring system of claim 59 , wherein the alarm is configured to indicate when a level of an analyte is near a threshold level.
Claim 64
Dependent Claim 26 words
The analyte monitoring system of claim 60 , wherein the alarm is configured to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.
Claim 65
Dependent Claim 28 words
The analyte monitoring system of claim 61 , wherein the alarm is configured to indicate impending hypoglycemia and is deactivated if an impending hypoglycemia condition does not exist.
Claim 66
Dependent Claim 21 words
The analyte monitoring system of claim 61 , wherein the alarm is configured to indicate hypoglycemia and is only manually deactivatable.
Claim 67
Dependent Claim 31 words
The analyte monitoring system of claim 61 , wherein the alarm is configured to indicate hypoglycemia and the alarm, when activated, produces an audible signal that increases in loudness over time.
Claim 68
Dependent Claim 35 words
The analyte monitoring system of claim 59 , wherein the analyte monitoring system comprises at least two alarms, each alarm producing an audible signal, wherein the signals of the at least two alarms are distinguishable.
Claim 69
Dependent Claim 37 words
The analyte monitoring system of claim 39 , further comprising a processing circuit in the display unit, the processing circuit being configured to analyze patient-specific data from multiple episodes to predict a patient's response to future episodes.
Claim 70
Dependent Claim 18 words
The analyte monitoring system of claim 66 , wherein the patient-specific data comprises a response to a treatment.
Claim 71
Dependent Claim 21 words
The analyte monitoring system of claim 67 , wherein the analyte is glucose and the treatment is an administration of insulin.
Claim 72
Dependent Claim 24 words
The analyte monitoring system of claim 67 , wherein the display unit further comprises an input device for indicating when a treatment is administered.
Claim 73
Dependent Claim 26 words
The analyte monitoring system of claim 66 , wherein the processing circuit is configured to determine a drug administration protocol in response to the patient-specific data.
Claim 74
Dependent Claim 22 words
The analyte monitoring system of claim 66 , wherein the patient-specific data is a dosage dependence of a response to a drug.
Claim 75
Dependent Claim 24 words
The analyte monitoring system of claim 66 , wherein the display unit further comprises an input device for indicating when food has been injested.
Claim 76
Dependent Claim 23 words
The analyte monitoring system of claim 72 , where the input device is configured for indicating an approximate caloric content of the food.
Claim 77
Dependent Claim 21 words
The analyte monitoring system of claim 39 , further comprising a temperature measurement device to correct data obtained from the sensor.
Claim 78
Dependent Claim 21 words
The analyte monitoring system of claim 74 , wherein the temperature measurement device comprises a temperature probe disposed on the substrate.
Claim 79
Dependent Claim 30 words
The analyte monitoring system of claim 39 , wherein the analyte monitoring system further comprises a drug administration system which dispenses a drug based on the level of the analyte.
Claim 80
Dependent Claim 37 words
The analyte monitoring system of claim 76 , wherein the drug administration system comprises a receiver for receiving data from at least one of the sensor control unit or display unit to direct dispensing of the drug.
Claim 81
Dependent Claim 31 words
The analyte monitoring system of claim 76 , wherein the drug administration system comprises at least one of a needle, syringe, pump, catheter, inhaler, or transdermal patch to administer the drug.
Claim 82
Dependent Claim 13 words
The analyte monitoring system of claim 76 , wherein the drug is insulin.
Claim 83
Dependent Claim 115 words
A method for monitoring a level of an analyte using the analyte monitoring system of claim 39 , the method comprising: inserting the sensor into skin of a patient; attaching the sensor control unit to the skin of the patient; coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor; collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor; transmitting the collected data to the display unit using the rf transmitter of the sensor control unit; and displaying an indication of the level of the analyte on the display of the display unit.
Claim 84
Dependent Claim 21 words
The method of claim 80 , wherein collecting data comprises generating signals from the sensor and processing the signals into data.
Claim 85
Dependent Claim 15 words
The method of claim 80 , wherein the data comprises the signals from the sensor.
Claim 86
Dependent Claim 18 words
The method of claim 80 , further comprising activating an alarm if the data indicates an alarm condition.
Claim 87
Dependent Claim 16 words
The method of claim 80 , further comprising administering a drug in response to the data.
Claim 88
Dependent Claim 20 words
The method of claim 80 , further comprising obtaining a calibration value from a calibration device to calibrate the data.
Claim 89
Dependent Claim 16 words
The method of claim 85 , wherein the calibration device is coupled to the display unit.
Claim 90
Dependent Claim 27 words
The method of claim 86 , further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the sensor control unit.
Claim 91
Dependent Claim 188 words
An analyte monitoring system comprising: (a) a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin; (b) a sensor control unit comprising, (i) a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads; (ii) a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and (iii) an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor; and (c) a display unit comprising a receiver for receiving data from the sensor control unit, and a display coupled to the receiver for displaying an indication of the level of an analyte, wherein the transmitter of the sensor control unit and the receiver of the display unit are capable of transmitting and receiving data when separated by a distance of two meters.
Claim 92
Dependent Claim 188 words
An analyte monitoring system comprising: (a) a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin; (b) a sensor control unit comprising, (i) a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads; (ii) a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and (iii) an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor; and (c) a display unit comprising a receiver for receiving data from the sensor control unit, and a display coupled to the receiver for displaying an indication of the level of an analyte, wherein the transmitter of the sensor control unit and the receiver of the display unit are capable of transmitting and receiving data when separated by a distance of two meters.
Claim 93
Dependent Claim 81 words
A sensor control unit comprising: a housing adapted for placement on skin and adapted to receive a portion of an independent electrochemical sensor extending out of the skin and having at least one contact pad; at least one conductive contact configured for coupling to the at least one contact pad on the independent electrochemical sensor; and an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the independent electrochemical sensor.
Claim 94
Dependent Claim 81 words
A sensor control unit comprising: a housing adapted for placement on skin and adapted to receive a portion of an independent electrochemical sensor extending out of the skin and having at least one contact pad; at least one conductive contact configured for coupling to the at least one contact pad on the independent electrochemical sensor; and an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the independent electrochemical sensor.
Claim 95
Dependent Claim 127 words
A method for monitoring a level of an analyte using the analyte monitoring system of claim 39 , the method comprising: inserting the sensor into skin of a patient; attaching the sensor control unit to the skin of the patient; coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor; collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor; transmitting the collected data to the display unit using the rf transmitter of the sensor control unit; displaying an indication of the level of the analyte on the display of the display unit; and replacing the sensor with a new sensor after a period of use.
Claim 96
Dependent Claim 30 words
The analyte monitoring system of claim 74 , wherein the analyte monitoring system if configured and arranged to determine a temperature near the sensor using two electrodes of the sensor.
Claim 97
Dependent Claim 24 words
The analyte monitoring system of claim 39 , wherein the sensor further comprises an enzyme non-leachably disposed on the at least one working electrode.
Claim 98
Dependent Claim 22 words
The analyte monitoring system of claim 39 , wherein the working electrode comprises a mixture of conductive material and an analyte-responsive enzyme.
Claim 99
Dependent Claim 62 words
The analyte monitoring system of claim 39 , wherein the sensor further comprises a mass transport limiting membrane disposed over the working electrode, the mass transport limiting member maintaining a rate of permeation of the analyte through the mass transport limiting membrane with a variation of no more than 3% per ° C. at temperatures ranging from 30° C. to 40° C.

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2004-01-16 2004-07-17 2005-01-16 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2008-01-16 2008-07-17 2009-01-16 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2012-01-16 2012-07-17 2013-01-16 $7700.00 Window Closed / Lapsed

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