GLUCOSE SENSOR CALIBRATION
First Claim
1. A process for calibrating a glucose sensor in a sterile environment, the glucose sensor comprising a sensing probe for detecting glucose, the process comprising:
- (i) providing a calibration unit comprising (a) at least a first and a second sterile calibration fluid, each calibration fluid having a different concentration of glucose, (b) a sensing zone, a sensing region of the probe of the glucose sensor being located within the sensing zone, and (c) a waste chamber for collecting used calibration fluid;
(ii) providing the first calibration fluid to the sensing zone such that the fluid is in contact with the sensing region, and determining the sensor output;
(iii) flushing the first calibration fluid to the waste chamber;
(iv) providing the second calibration fluid to the sensing zone such that the fluid is in contact with the sensing region, and determining the sensor output;
(v) using the sensor output readings to calibrate the glucose sensor;
wherein the calibration process is carried out under sterile conditions, and wherein said glucose sensor is an invasive fibre optic glucose sensor containing a fluorescent glucose indicator system, the sensor probe being adapted to detect glucose in vivo.
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Accused Products
Abstract
A process for calibrating a glucose sensor under sterile conditions includes providing separate, sterile, glucose-containing calibration fluids, each having a different glucose concentration, and in turn providing these fluids to a sensing zone containing a sensing probe of a glucose sensor. Each solution is typically, in turn, propelled into the sensing zone, thus flushing out used fluid already present in the sensing zone. The process provides rapid calibration of a glucose sensor in a sterile fashion and is therefore appropriate for point-of-use calibration.
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Citations
24 Claims
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1. A process for calibrating a glucose sensor in a sterile environment, the glucose sensor comprising a sensing probe for detecting glucose, the process comprising:
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(i) providing a calibration unit comprising (a) at least a first and a second sterile calibration fluid, each calibration fluid having a different concentration of glucose, (b) a sensing zone, a sensing region of the probe of the glucose sensor being located within the sensing zone, and (c) a waste chamber for collecting used calibration fluid; (ii) providing the first calibration fluid to the sensing zone such that the fluid is in contact with the sensing region, and determining the sensor output; (iii) flushing the first calibration fluid to the waste chamber; (iv) providing the second calibration fluid to the sensing zone such that the fluid is in contact with the sensing region, and determining the sensor output; (v) using the sensor output readings to calibrate the glucose sensor; wherein the calibration process is carried out under sterile conditions, and wherein said glucose sensor is an invasive fibre optic glucose sensor containing a fluorescent glucose indicator system, the sensor probe being adapted to detect glucose in vivo. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 24)
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12. A calibration unit for calibrating an invasive fibre optic glucose sensor, said sensor containing a fluorescent glucose indicator system and a sensor probe being adapted to detect glucose in vivo, wherein said calibration unit comprises:
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a sensing zone having at least one inlet and at least one outlet, the sensing zone being arranged to house a sensing region of a sensing probe of the glucose sensor; a first calibration chamber containing a first sterile calibration fluid, the first calibration chamber being connected to, or adapted for connection to, an inlet to the sensing zone; a second calibration chamber containing a second sterile calibration fluid having a glucose concentration different from that of the first calibration fluid, the second calibration chamber being connected to, or adapted for connection to, an inlet to the sensing zone; at least one fluid propulsion means for propelling calibration fluid from the calibration chambers to the sensing zone; a waste chamber arranged to collect used calibration fluid which is flushed out of the sensing zone; the calibration unit being arranged to carry out calibration of the sensor under sterile conditions. - View Dependent Claims (13, 14, 15)
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16. A process for the preparation of a calibration unit for calibrating a glucose sensor, comprising the steps:
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providing glucose in solid form in a first mixing chamber, and water or an aqueous solution in a second mixing chamber; (ii) sterilising the first and second mixing chambers by use of heat or irradiation; (iii) mixing the contents of the first and second chambers to provide a first, sterile glucose-containing calibration fluid; (iv) providing at least a portion of the first calibration fluid to a first calibration chamber, whilst maintaining sterility of the fluid; (v) providing at least one further sterile calibration fluid, each further fluid having a glucose concentration different from one another and from the first calibration fluid, the further calibration fluid(s) being provided in one or more further calibration chambers; (vi) connecting the first and one or more further calibration chambers to a calibration unit such that the calibration chambers are connected to, or adapted for connection to, an inlet to a sensing zone of the calibration unit; (vii) sterilising the calibration unit using a surface sterilant, said sterilising step being carried out either before or after step (vi), to provide a sterile calibration unit containing at least two sterile calibration fluids. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23)
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Specification