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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | UP-0645097 (2009-12-22) |
등록번호 | US-7792562 (2010-09-27) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
|
인용정보 | 피인용 횟수 : 238 인용 특허 : 458 |
Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices, that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices com
Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices, that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices comprise a unique microarchitectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.
What is claimed is: 1. A device for measuring a glucose concentration in a host, the device comprising: a sensor operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located o
What is claimed is: 1. A device for measuring a glucose concentration in a host, the device comprising: a sensor operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located over at least a portion of the sensor, the membrane comprising a layer configured to control a flux of oxygen and glucose; wherein the device is capable of exhibiting, at a glucose concentration of 400 mg/dL, no more than a 10% drop in sensor output over a range of pO2 from 150 mm Hg down to 30 mm Hg, and wherein the device is configured to use an in vitro calibration factor for initial calibration. 2. The device of claim 1, wherein the sensor comprises a first electrode formed at least in part from a platinum wire. 3. The device of claim 2, wherein the sensor further comprises a second electrode formed at least in part from a silver wire. 4. The device of claim 3, wherein the membrane is located over the first electrode and the second electrode. 5. The device of claim 1, wherein the membrane comprises a layer comprising an enzyme. 6. The device of claim 1, wherein the membrane comprises an electrolyte layer. 7. The device of claim 1, wherein the membrane comprises a water-swellable film. 8. The device of claim 1, wherein the membrane comprises polyvinylpyrrolidone. 9. The device of claim 1, wherein the membrane comprises a urethane polymer or a polyurethane. 10. The device of claim 9, wherein the urethane polymer or polyurethane comprises a polycarbonate-polyurethane backbone. 11. The device of claim 1, wherein the membrane comprises a block copolymer. 12. The device of claim 1, wherein the membrane comprises a block copolyurethaneurea. 13. The device of claim 1, wherein the layer configured to control a flux of oxygen and glucose is monolithic and homogeneous. 14. The device of claim 1, wherein the layer configured to control a flux of oxygen and glucose is monolithic and heterogeneous. 15. The device of claim 1, wherein at least 95%of glucose concentration values measured by the device are within 25% of corresponding values determined by analysis of blood over the period of time. 16. The device of claim 1, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 500 mg/dL. 17. The device of claim 1, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 15microns to about 40 microns. 18. The device of claim 1, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 25microns to about 35 microns. 19. The device of claim 1, wherein the membrane has a thickness of from about 40 microns to about 60 microns. 20. The device of claim 1, wherein the period of time is at least about 3 days. 21. The device of claim 1, wherein the period of time is at least about 5 days. 22. The device of claim 1, wherein the period of time is at least about 7 days. 23. The device of claim 1, wherein an offset current defined by a current at 0 mg/dL is configured to remain stable over the period of time. 24. The device of claim 1, wherein the device is capable of obtaining a calibration stability that is maintained within 10% for one week. 25. The device of claim 1, wherein the device is configured for single-point recalibration. 26. The device of claim 1, wherein the device is configured to be implanted in the host. 27. The device of claim 1, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to at least 400 mg/dL. 28. A device for measuring a glucose concentration in a host, the device comprising: an electrode surface operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located over at least a portion of the electrode surface, the membrane comprising a layer configured to control a flux of oxygen and glucose; wherein the device is capable of exhibiting, at a glucose concentration of 400 mg/dL, no more than a 10% drop in sensor output over a range of pO2 from 150 mm Hg down to 30 mm Hg; and wherein the device is configured to be implanted in the host. 29. The device of claim 28, wherein the device comprises a first electrode formed at least in part from a platinum wire. 30. The device of claim 29, wherein the device further comprises a second electrode formed at least in part from a silver wire. 31. The device of claim 30, wherein the membrane is located over the first electrode and the second electrode. 32. The device of claim 28, wherein the membrane comprises a layer comprising an enzyme. 33. The device of claim 28, wherein the membrane comprises an electrolyte layer. 34. The device of claim 28, wherein the membrane comprises a water-swellable film. 35. The device of claim 28, wherein the membrane comprises polyvinylpyrrolidone. 36. The device of claim 28, wherein the membrane comprises a urethane polymer or a polyurethane. 37. The device of claim 36, wherein the urethane polymer or polyurethane comprises a polycarbonate-polyurethane backbone. 38. The device of claim 28, wherein the membrane comprises a block copolymer. 39. The device of claim 28, wherein the membrane comprises a block copolyurethaneurea. 40. The device of claim 28, wherein the layer configured to control a flux of oxygen and glucose is monolithic and homogeneous. 41. The device of claim 28, wherein the layer configured to control a flux of oxygen and glucose is monolithic and heterogeneous. 42. The device of claim 28, wherein at least 95% of glucose concentration values measured by the device are within 25% of corresponding values determined by analysis of blood over the period of time. 43. The device of claim 28, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 500 mg/dL. 44. The device of claim 28, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 15microns to about 40 microns. 45. The device of claim 28, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 25microns to about 35 microns. 46. The device of claim 28, wherein the membrane has a thickness of from about 40 microns to about 60 microns. 47. The device of claim 28, wherein the period of time is at least about 3 days. 48. The device of claim 28, wherein the period of time is at least about 5 days. 49. The device of claim 28, wherein the period of time is at least about 7 days. 50. The device of claim 28, wherein an offset current defined by a current at 0 mg/dL is configured to remain stable over the period of time. 51. The device of claim 28, wherein the device is capable of obtaining a calibration stability that is maintained within 10% for one week. 52. The device of claim 28, wherein the device is configured for single-point recalibration. 53. A device for measuring a glucose concentration in a host, the device comprising: a sensor operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located over at least a portion of the sensor, the membrane comprising a layer configured to control a flux of oxygen and glucose; wherein the device is capable of exhibiting, at a glucose concentration of 400 mg/dL, no more than a 10% drop in sensor output over a range of pO2 from 150 mm Hg down to 30 mm Hg; and wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to at least 400 mg/dL. 54. The device of claim 53, wherein the device comprises a first electrode formed at least in part from a platinum wire. 55. The device of claim 54, wherein the device further comprises a second electrode formed at least in part from a silver wire. 56. The device of claim 55, wherein the membrane is located over the first electrode and the second electrode. 57. The device of claim 53, wherein the membrane comprises a layer comprising an enzyme. 58. The device of claim 53, wherein the membrane comprises an electrolyte layer. 59. The device of claim 53, wherein the membrane comprises a water-swellable film. 60. The device of claim 53, wherein the membrane comprises polyvinylpyrrolidone. 61. The device of claim 53, wherein the membrane comprises a urethane polymer or a polyurethane. 62. The device of claim 61, wherein the urethane polymer or polyurethane comprises a polycarbonate-polyurethane backbone. 63. The device of claim 53, wherein the membrane comprises a block copolymer. 64. The device of claim 53, wherein the membrane comprises a block copolyurethaneurea. 65. The device of claim 53, wherein the layer configured to control a flux of oxygen and glucose is monolithic and homogeneous. 66. The device of claim 53, wherein the layer configured to control a flux of oxygen and glucose is monolithic and heterogeneous. 67. The device of claim 53, wherein at least 95%of glucose concentration values measured by the device are within 25% of corresponding values determined by analysis of blood over the period of time. 68. The device of claim 53, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 500 mg/dL. 69. The device of claim 53, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 15microns to about 40 microns. 70. The device of claim 53, wherein the membrane has a thickness of from about 25 microns to about 35 microns. 71. The device of claim 53, wherein the membrane has a thickness of from about 40 microns to about 60 microns. 72. The device of claim 53, wherein the period of time is at least about 3 days. 73. The device of claim 53, wherein the period of time is at least about 5 days. 74. The device of claim 53, wherein the period of time is at least about 7 days. 75. The device of claim 53, wherein an offset current defined by a current at 0 mg/dL is configured to remain stable over the period of time. 76. The device of claim 53, wherein the device is capable of obtaining a calibration stability that is maintained within 10% for one week. 77. The device of claim 53, wherein the device is configured for single-point recalibration. 78. The device of claim 53, wherein the device is configured to be implanted in the host. 79. The device of claim 53, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to at least 400 mg/dL. 80. A device for measuring a glucose concentration in a host, the device comprising: a sensor operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located over at least a portion of the sensor, the membrane comprising a layer configured to control a flux of oxygen and glucose; wherein the device is capable of exhibiting, at a glucose concentration of 400 mg/dL, no more than a 10% drop in sensor output over a range of pO2 from 150 mm Hg down to 30 mm Hg; and wherein the device is capable of attaining a 90% time response to a 100 mg/dL glucose concentration step in less than 5minutes. 81. The device of claim 80, wherein the device comprises a first electrode formed at least in part from a platinum wire. 82. The device of claim 81, wherein the device further comprises a second electrode formed at least in part from a silver wire. 83. The device of claim 82, wherein the membrane is located over the first electrode and the second electrode. 84. The device of claim 80, wherein the membrane comprises a layer comprising an enzyme. 85. The device of claim 80, wherein the membrane comprises an electrolyte layer. 86. The device of claim 80, wherein the membrane comprises a water-swellable film. 87. The device of claim 80, wherein the membrane comprises polyvinylpyrrolidone. 88. The device of claim 80, wherein the membrane comprises a urethane polymer or a polyurethane. 89. The device of claim 88, wherein the urethane polymer or polyurethane comprises a polycarbonate-polyurethane backbone. 90. The device of claim 80, wherein the membrane comprises a block copolymer. 91. The device of claim 80, wherein the membrane comprises a block copolyurethaneurea. 92. The device of claim 80, wherein the layer configured to control a flux of oxygen and glucose is monolithic and homogeneous. 93. The device of claim 80, wherein the layer configured to control a flux of oxygen and glucose is monolithic and heterogeneous. 94. The device of claim 80, wherein at least 95% of glucose concentration values measured by the device are within 25% of corresponding values determined by analysis of blood over the period of time. 95. The device of claim 80, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 500 mg/dL. 96. The device of claim 80, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 15microns to about 40 microns. 97. The device of claim 80, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 25microns to about 35 microns. 98. The device of claim 80, wherein the membrane has a thickness of from about 40 microns to about 60 microns. 99. The device of claim 80, wherein the period of time is at least about 3 days. 100. The device of claim 80, wherein the period of time is at least about 5 days. 101. The device of claim 80, wherein the period of time is at least about 7 days. 102. The device of claim 80, wherein an offset current defined by a current at 0 mg/dL is configured to remain stable over the period of time. 103. The device of claim 80, wherein the device is capable of obtaining a calibration stability that is maintained within 10% for one week. 104. The device of claim 80, wherein the device is configured for single-point recalibration. 105. The device of claim 80, wherein the device is configured to be implanted in the host. 106. The device of claim 80, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to at least 400 mg/dL. 107. A device for measuring a glucose concentration in a host, the device comprising: a sensor operably connected to an electronic circuit and configured to continuously measure a signal indicative of a glucose concentration in a host for a period of time; and a membrane located over at least a portion of the sensor, wherein the membrane comprises a layer configured to control a flux of oxygen and glucose, wherein the layer comprises a polyurethane or urethane polymer; wherein the device is capable of exhibiting, at a glucose concentration of 400 mg/dL, no more than a 10% drop in sensor output over a range of pO2 from 150 mm Hg down to 30 mm Hg. 108. The device of claim 107, wherein the device comprises a first electrode formed at least in part from a platinum wire. 109. The device of claim 108, wherein the device further comprises a second electrode formed at least in part from a silver wire. 110. The device of claim 109, wherein the membrane is located over the first electrode and the second electrode. 111. The device of claim 107, wherein the membrane comprises a layer comprising an enzyme. 112. The device of claim 107, wherein the membrane comprises an electrolyte layer. 113. The device of claim 107, wherein the membrane comprises a water-swellable film. 114. The device of claim 107, wherein the membrane comprises polyvinylpyrrolidone. 115. The device of claim 107, wherein the urethane polymer or polyurethane comprises a polycarbonate-polyurethane backbone. 116. The device of claim 107, wherein the membrane comprises a block copolymer. 117. The device of claim 107, wherein the membrane comprises a block copolyurethaneurea. 118. The device of claim 107, wherein the layer configured to control a flux of oxygen and glucose is monolithic and homogeneous. 119. The device of claim 107, wherein the layer configured to control a flux of oxygen and glucose is monolithic and heterogeneous. 120. The device of claim 107, wherein at least 95% of glucose concentration values measured by the device are within 25% of corresponding values determined by analysis of blood over the period of time. 121. The device of claim 107, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 500 mg/dL. 122. The device of claim 107, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 15microns to about 40 microns. 123. The device of claim 107, wherein the layer configured to control a flux of oxygen and glucose has a thickness of from about 25microns to about 35 microns. 124. The device of claim 107, wherein the membrane has a thickness of from about 40 microns to about 60 microns. 125. The device of claim 107, wherein the period of time is at least about 3 days. 126. The device of claim 107, wherein the period of time is at least about 5 days. 127. The device of claim 107, wherein the period of time is at least about 7 days. 128. The device of claim 107, wherein an offset current defined by a current at 0 mg/dL is configured to remain stable over the period of time. 129. The device of claim 107, wherein the device is capable of obtaining a calibration stability that is maintained within 10% for one week. 130. The device of claim 107, wherein the device is configured for single-point recalibration. 131. The device of claim 107, wherein the device is configured to be implanted in the host. 132. The device of claim 107, wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to at least 400 mg/dL.
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