Method and implantable system for blood-glucose concentration monitoring
First Claim
1. A method comprising:
- monitoring blood-glucose concentration in blood of a subject using a system implanted in a subject wherein the system has stored relationships therein between blood-glucose concentration and at least a first physiological metric, and wherein the system implanted in the subject performs the steps of(a) obtaining a measure of the first physiological metric using one or more sensors of the system implanted in the subject; and
(b) calculating the blood-glucose concentration using the stored relationships and the measure of the first physiological metric without using a measure obtained from an enzymatic sensor;
wherein the first physiological metric is a blood oxygen metric.
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Abstract
In an implantable medical device for monitoring blood-glucose concentration in the blood, metabolic oxygen consumption is derived by measuring physiological metrics related to mixed venous oxygen concentration. Blood-glucose concentration is determined using correlations of blood-glucose concentration with measures of metabolic oxygen consumption including oxymetric, temperature, and electrocardiographic data. Additional physiological sensor measurements may be used to enhance the accuracy of the analysis of blood-glucose concentration. By using a combination of oxymetric and other physiological metrics, blood-glucose concentration can be reliably calculated over a wide range. The device compares the blood-glucose concentration with upper and lower acceptable bounds and generates appropriate warning signals if the concentration falls outside the bounds. The device may also control a therapeutic device to maintain blood-glucose concentration within an acceptable range. A calibration technique determines patient-specific parameters for use in the calculation of blood-glucose concentration.
62 Citations
37 Claims
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1. A method comprising:
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monitoring blood-glucose concentration in blood of a subject using a system implanted in a subject wherein the system has stored relationships therein between blood-glucose concentration and at least a first physiological metric, and wherein the system implanted in the subject performs the steps of (a) obtaining a measure of the first physiological metric using one or more sensors of the system implanted in the subject; and (b) calculating the blood-glucose concentration using the stored relationships and the measure of the first physiological metric without using a measure obtained from an enzymatic sensor; wherein the first physiological metric is a blood oxygen metric. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. An implantable system for monitoring blood-glucose concentration in a subject wherein the system comprises:
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a memory which has stored therein relationships between blood-glucose concentration and at least a first physiological metric; a first sensor which obtains a measure of the first physiological metric; and a controller which calculates the blood-glucose concentration using the stored relationships and the measure of the first physiological metric; wherein the system is adapted to be implanted in a subject, the first sensor is an implantable oxymeter, and the first physiological metric is a blood oxygen metric; and wherein the system does not include an enzymatic sensor. - View Dependent Claims (18, 19, 20, 21)
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22. A method performed by an external device in conjunction with an implantable medical device implanted within a subject, the method comprising:
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obtaining, using the external device, a blood-glucose concentration of the subject at each of a plurality of times, to thereby obtain a plurality of different blood-glucose concentrations; obtaining, using the implantable medical device, measures of one or more physiological metrics at each of the plurality of times; transmitting, from the implantable medical device to the external device, data indicative of the measures of said one or more physiological metrics obtained at the plurality of times; determining, using the external device, from the data indicative of the measures of said one or more physiological metrics at the plurality of times, parameters which enable the implantable medical device to derive blood-glucose concentrations for the subject from subsequently-obtained measures of said one or more physiological metrics; transmitting the parameters to the implanted device; and determining, using the implantable medical device implanted within a subject, the blood-glucose concentration of the subject, using the parameters and the subsequently-obtained measures of said one or more physiological metrics; wherein said one or more physiological metrics include at least one blood oxygen metric. - View Dependent Claims (23, 24, 25, 26, 27)
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28. A method comprising:
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monitoring blood-glucose concentration in blood of a subject using a system implanted in the subject, wherein the system has stored relationships therein between blood-glucose concentration and a first physiological metric, a second physiological metric, and a third physiological metric, and wherein the system implanted in the subject performs the steps of; (a) obtaining, using one or more sensors and/or electrodes of the system implanted within the subject, a measure of the first physiological metric which is a physiological metric selected from the group consisting of a metric of venous oxygen saturation and a metric of hematocrit, a measure of the second physiological metric which is a physiological metric, other than the first physiological metric, selected from the group consisting of a metric of hematocrit, a metric of core temperature, a metric of peripheral temperature, a metric of blood pressure, a metric of blood flow, and a metric of heart rate, and a measure of the third physiological metric which is a metric, other than the first and second physiological metrics, selected from the group consisting of a metric of hematocrit, a metric of blood pressure, a metric of blood flow, and a metric of heart rate; and (b) calculating the blood-glucose concentration using the stored relationships, the first physiological metric, the second physiological metric, and the third physiological metric. - View Dependent Claims (29, 30, 31, 32, 33, 34)
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35. An implantable system for monitoring blood-glucose concentration in a subject wherein the implantable system comprises:
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a memory which has stored therein relationships between blood-glucose concentration and a first physiological metric, a second physiological metric, and a third physiological metric; one or more implantable sensors and/or electrodes which obtain, a measure of the first physiological metric, wherein the first physiological metric is a blood oxygen metric, a measure of the second physiological metric, wherein the second physiological metric is a metric, other than the first physiological metric, selected from the group consisting of a metric of venous oxygen saturation, a metric of hematocrit, a metric of arterial oxygen saturation, a metric of peripheral temperature, a metric of core temperature, a metric of blood pressure, a metric of blood flow, and a metric of heart-rate, and a measure of the third physiological metric, wherein the third physiological metric is a metric, other than the first and second physiological metrics, selected from the group consisting of a metric of venous oxygen saturation, a metric of hematocrit, a metric of arterial oxygen saturation, a metric of peripheral temperature, a metric of core temperature, a metric of blood pressure, a metric of blood flow, and a metric of heart-rate; and a controller which calculates the blood-glucose concentration using the stored relationships, the measure of the first physiological metric, the measure of the second physiological metric, and the measure of the third physiological metric. - View Dependent Claims (36, 37)
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Specification