최소 단어 이상 선택하여야 합니다.
최대 10 단어까지만 선택 가능합니다.
다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
NTIS 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
DataON 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Edison 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0825692 (2010-06-29) |
등록번호 | US-9326714 (2016-05-03) |
발명자 / 주소 |
|
출원인 / 주소 |
|
대리인 / 주소 |
|
인용정보 | 피인용 횟수 : 1 인용 특허 : 1645 |
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
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.
1. An analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor compri
1. An analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; anda readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; andan adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin. 2. The analyte sensor unit of claim 1, wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin. 3. The analyte sensor unit of claim 1, wherein the electrochemical sensor has a length of about 0.3 to about 5 cm and comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing. 4. The analyte sensor unit of claim 3, wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing. 5. The analyte sensor unit of claim 3, wherein the distal end of the electrochemical sensor has a length of up to about 6 mm. 6. The analyte sensor unit of claim 3, wherein the electrochemical sensor has a length of up to about 2 cm. 7. The analyte sensor unit of claim 1, wherein the housing comprises a data storage unit to store analyte data obtained by the electrochemical sensor. 8. The analyte sensor unit of claim 1, wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode. 9. The analyte sensor unit of claim 8, wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor. 10. The analyte sensor unit of claim 9, wherein automatically detecting use further comprises activating the analyte sensor unit. 11. The analyte sensor unit of claim 1, wherein the RF communication unit receives data from a second RF communication unit of a display unit. 12. The analyte sensor unit of claim 11, wherein data received by the RF communication unit comprises an activation signal. 13. The analyte sensor unit of claim 12, wherein the electrical contacts are disposed on an interior surface of the housing. 14. The analyte sensor unit of claim 1, further comprising a processor to determine the rate of change of the glucose. 15. The analyte sensor unit of claim 1, further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor. 16. The analyte sensor unit of claim 15, wherein the processing circuit adjusts the data for temperature using a signal from a temperature probe of the sensor. 17. The analyte sensor unit of claim 1, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer. 18. The analyte sensor unit of claim 17, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more carbon-carbon, carbon-nitrogen, or metal-carbon covalent bonds to the polymer. 19. The analyte sensor unit of claim 18, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents. 20. The analyte sensor unit of claim 19, wherein the crosslinking agent is one or more of substituted or unsubstituted epoxides, aldehydes, imidoesters, N-hydroxysuccinimide esters, carbodiimides, cyanuric chloride, tetrachlorobenzoquinone, benzoquinone and tetracyanoquinodimethane. 21. The analyte sensor unit of claim 17, wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator. 22. The analyte sensor unit of claim 21, wherein the one or more ligands comprises a substituted or unsubstituted heterocyclic nitrogen-containing moiety. 23. The analyte sensor unit of claim 17, wherein one or more ligands of the mediator are crosslinkers of the polymer. 24. The analyte sensor unit of claim 17, wherein one or more ligands of the mediator are substituents of the polymer backbone. 25. The analyte sensor unit of claim 17, wherein the analyte-responsive enzyme is crosslinked with the polymer by at least one covalent bond to one or more side chains of the enzyme. 26. The analyte sensor unit of claim 25, wherein the one or more side chains of the analyte-responsive enzyme is selected from the group consisting of substituted or unsubstituted amines, alcohols, thiols, phenols, imidazoles, indols, and carboxylic acids. 27. The analyte sensor unit of claim 25, wherein the one or more side chains of the analyte-responsive enzyme are crosslinkers of the polymer. 28. The analyte sensor unit of claim 25, wherein the one or more side chains of the analyte-responsive enzyme are substituents of the polymer backbone. 29. The analyte sensor unit of claim 1, wherein the polymer forms a coordination complex with the mediator. 30. The analyte sensor unit of claim 29, wherein one or more nitrogen-containing moieties of the polymer forms a coordination complex with a metal of the mediator. 31. The analyte sensor unit of claim 1, wherein the mediator is crosslinked with the polymer by one or more ionic bonds to the mediator. 32. The analyte sensor unit of claim 31, wherein the polymer comprises at least one positively charged moiety and the mediator comprises at least one negatively charged moiety. 33. The analyte sensor unit of claim 31, wherein the polymer comprises at least one negatively charged moiety and the mediator comprises at least one positively charged moiety. 34. The analyte sensor unit of claim 1, wherein the polymer is chemically bonded to the surface of the working electrode. 35. The analyte sensor unit of claim 1, wherein the sensing layer membrane is formed in situ on the working electrode. 36. The analyte sensor unit of claim 35, wherein the sensing layer membrane is formed in situ on the working electrode by crosslinking the polymer on the working electrode. 37. The analyte sensor unit of claim 1, wherein the working electrode further comprises a mass transport limiting membrane disposed over the sensing layer membrane. 38. The analyte sensor unit of claim 1, wherein the analyte-responsive enzyme is a glucose-responsive enzyme. 39. The analyte sensor unit of claim 1, wherein the analyte-responsive enzyme is glucose dehydrogenase (GDH) or glucose oxidase (GOx). 40. The analyte sensor unit of claim 1, wherein the analyte-responsive enzyme further comprises an enzyme cofactor. 41. The analyte sensor unit of claim 10, wherein the enzyme cofactor is flavin adenine dinucleotide. 42. The analyte sensor unit of claim 1, wherein the mediator comprises ruthenium or osmium. 43. An analyte monitoring system for determining the concentration of an analyte comprising: an analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; anda readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; andan adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; anda display unit comprising a housing, wherein the housing comprises: a second RF communication unit for communicating with the first wireless communication unit; anda display to display the concentration of an analyte. 44. The analyte monitoring system of claim 43, wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin. 45. The analyte monitoring system of claim 43, wherein the electrochemical sensor has a length of about 0.3 to about 5 cm and that a proximal end of the electrochemical sensor is in contact with electrical contacts within the housing and a distal of the electrochemical sensor extends through an opening at the bottom of the housing. 46. The analyte monitoring system of claim 45, wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing. 47. The analyte monitoring system of claim 45, wherein the distal end of the electrochemical sensor has a length of up to about 6 mm. 48. The analyte monitoring system of claim 45, wherein the electrochemical sensor has a length of up to about 2 cm. 49. The analyte monitoring system of claim 43, wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode. 50. The analyte monitoring system of claim 49, wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor. 51. The analyte monitoring system of claim 50, wherein automatically detecting use further comprises activating the analyte sensor unit. 52. The analyte monitoring system of claim 43, wherein the first RF communication unit receives data from a second RF communication unit of a display unit. 53. The analyte monitoring system of claim 52, wherein data received by the RF communication unit comprises an activation signal. 54. The analyte monitoring system of claim 45, wherein the electrical contacts are disposed on an interior surface of the housing. 55. The analyte monitoring system of claim 43, further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor. 56. The analyte monitoring system of claim 43, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer. 57. The analyte monitoring system of claim 56, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents. 58. The analyte monitoring system of claim 56, wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator. 59. An analyte monitoring system for determining the concentration of an analyte comprising: an analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; anda readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; andan adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin; anda display unit comprising a housing, wherein the housing comprises: a second RF communication unit to communicate with the first wireless communication unit;a display for displaying the concentration of an analyte; anda test port to receive an in-vitro analyte sensor. 60. The analyte monitoring system of claim 59, wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin. 61. The analyte monitoring system of claim 59, wherein the electrochemical sensor has a length of about 0.3 to about 5 cm and that a proximal end of the electrochemical sensor is in contact with electrical contacts within the housing and a distal end of the electrochemical sensor extends through an opening at the bottom of the housing. 62. The analyte monitoring system of claim 61, wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing. 63. The analyte monitoring system of claim 61, wherein the distal end of the electrochemical sensor has a length of up to about 6 mm. 64. The analyte monitoring system of claim 61, wherein the electrochemical sensor has a length of up to about 2 cm. 65. The analyte monitoring system of claim 59, wherein the analyte sensor unit is automatically detects use following insertion by transitioning from a sleep mode to an active mode. 66. The analyte monitoring system of claim 65, wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor. 67. The analyte monitoring system of claim 66, wherein automatically detecting use further comprises activating the analyte sensor unit. 68. The analyte monitoring system of claim 59, wherein the first RF communication unit to receives data from a second RF communication unit of a display unit. 69. The analyte monitoring system of claim 68, wherein data received by the first RF communication unit comprises an activation signal. 70. The analyte monitoring system of claim 61, wherein the electrical contacts are disposed on an interior surface of the housing. 71. The analyte monitoring system of claim 59, further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor. 72. The analyte monitoring system of claim 59, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer. 73. The analyte monitoring system of claim 72, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents. 74. The analyte monitoring system of claim 72, wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator. 75. A method for attaching an analyte sensor unit to the skin of a patient, the method comprising: contacting an insertion device coupled with an analyte sensor unit to the skin of a patient; the analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; anda readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; andan adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin;applying manual pressure to the insertion device coupled with the analyte sensor unit to attach the analyte sensor unit to the skin using the adhesive;inserting at least a portion of the electrochemical sensor to a depth of about 2.0 to about 7 mm beneath the surface of the skin; anddecoupling the insertion device from the sensor control unit. 76. The method of claim 75, wherein the inserter is U-shaped or V-shaped. 77. The method of claim 75, wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin. 78. The method of claim 75, wherein the electrochemical sensor has a length of about 0.3 to about 5 cm so that a proximal end is in contact with electrical contacts within the housing and at least a portion of a distal end of the electrochemical sensor extends through an opening at the bottom of the housing. 79. The method of claim 78, wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing. 80. The method of claim 78, wherein the distal end of the electrochemical sensor has a length of up to about 6 mm. 81. The method of claim 78, wherein the electrochemical sensor has a length of up to about 2 cm. 82. The method of claim 75, wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode. 83. The method of claim 81, wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor. 84. The method of claim 83, wherein automatically detecting use further comprises activating the analyte sensor unit. 85. The method of claim 75, wherein the RF communication unit receives data from a second RF communication unit of a display unit. 86. The method of claim 85, wherein data received by the RF communication unit comprises an activation signal. 87. The method of claim 78, wherein the electrical contacts are disposed on an interior surface of the housing. 88. The method of claim 75, further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor. 89. The method of claim 75, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer. 90. The method of claim 89, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents. 91. The method of claim 89, wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator. 92. A method for monitoring the concentration of an analyte, the method comprising: contacting an insertion device coupled with an analyte sensor unit to the skin of a patient; the analyte sensor unit comprising: a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises: an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; anda readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; andan adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin;applying manual pressure to the insertion device coupled with the analyte sensor unit to attach the analyte sensor unit to the skin using the adhesive;inserting at least a portion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin;decoupling the insertion device from the sensor control unit;collecting data from the electrochemical sensor corresponding to the analyte;communicating the data to a display unit comprising a second RF communication unit and a display unit; anddisplaying a concentration of the analyte on the display unit. 93. The method of claim 92, wherein the inserter is U-shaped or V-shaped. 94. The method of claim 92, wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin. 95. The method of claim 92, wherein the electrochemical sensor has a length of about 0.3 to about 5 cm so that a proximal end is in contact with electrical contacts within the housing and at least a portion of a distal end of the electrochemical sensor extends through an opening at the bottom of the housing. 96. The method of claim 95, wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing. 97. The method of claim 95, wherein the distal end of the electrochemical sensor has a length of up to about 6 mm. 98. The method of claim 95, wherein the electrochemical sensor has a length of up to about 2 cm. 99. The method of claim 95, wherein the analyte sensor unit is automatically detects use following insertion by transitioning from a sleep mode to an active mode. 100. The method of claim 99, wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor. 101. The method of claim 100, wherein automatically detecting use further comprises activating the analyte sensor unit. 102. The method of claim 92, wherein the RF communication unit receives data from a second RF communication unit of a display unit. 103. The method of claim 102, wherein data received by the RF communication unit comprises an activation signal. 104. The method of claim 95, wherein the electrical contacts are disposed on an interior surface of the housing. 105. The method of claim 92, further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor. 106. The method of claim 92, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer. 107. The method of claim 106, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents. 108. The method of claim 106, wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator. 109. The analyte sensor unit of claim 1, wherein the substrate has a uniform thickness. 110. The analyte sensor unit of claim 1, wherein the substrate comprises a proximal end and distal end and wherein the width of the proximal end is different from the width of the distal end. 111. The analyte sensor unit of claim 110, wherein the width of the proximal end is greater than the width of the distal end. 112. The analyte sensor unit according to claim 1, wherein the working electrode comprises an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode. 113. The analyte monitoring system according to claim 43, wherein the working electrode comprises an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode. 114. The analyte monitoring system according to claim 59, wherein the working electrode comprises an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode. 115. The method according to claim 75, wherein the working electrode comprises an analyte-responsive enzyme and a mediator and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode.
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