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US6579690B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Blood analyte monitoring through subcutaneous measurement

Assignee: Abbott Diabetes Care Inc
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Filing: 1998-10-04
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Granted: 2003-06-17
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Expires: 2018-10-04
📄 Original PDF 🌐 Google Patents

Abstract

Abstract One embodiment of the invention is a method for obtaining an estimate of an analyte concentration in a first fluid. First, measurements of an analyte concentration in a second fluid are obtained using a sensing device. An analyte concentration estimate in the first fluid is determined from these measurements by minimizing the relation: f[b]=x2[b]+lambdΨ[b], where b is a vector representing analyte concentration in the first body fluid, X2[b] is a function representing a fit between the estimates and the measurements, lambd is a weighting function, and Ψ[b] is a function indicating smoothness of the analyte concentration estimates in the first fluid. Another embodiment includes a sensing device for obtaining the measurements of an analyte concentration in the first fluid and a processor configured and arranged to determine the analyte concentration in the first body fluid according to this method. This method and device can be used, for example, to determine blood glucose concentration from measurements of the glucose concentration in subcutaneous tissue. These measurements may be made using in vitro or in vivo samples. In some instances, a subcutaneously implanted sensing device, such as electrochemical sensor, is used to make the measurements.

Inventors

  • 👤 Roger T. Bonnecaze
  • 👤 Angela C. Freeland

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 12:24
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/48; A61B5/4836; A61B5/4839; A61B5/0002; A61B5/0031; A61B5/145; A61B5/14507; A61B5/1451; A61B5/14514; A61B5/14532; A61B5/74; A61B5/746; A61B5/1468; A61B5/1486; A61B5/72; A61B5/7203; Y; Y10; Y10S; Y10S435/00; Y10S435/817

Claims Analysis

Total Claims: 17
Claim 1
Independent Claim 170 words
A process for determining glucose concentration in blood, comprising: determining, from a sample of subcutaneous fluid, a subcutaneous glucose concentration, and from the subcutaneous glucose concentration, a glucose concentration in blood by calculation (i) based on a model accounting for mass transfer of the glucose from blood to a subcutaneous region and uptake of the glucose by subcutaneous tissue, and (ii) utilizing a regularization technique in the calculation, wherein the blood glucose concentration is determined from the subcutaneous glucose concentration using the relationship:  S  t = k m  A  ( B - S ) - Vk r ′  S K m + S ′ where V is the volume of the sensor, S is the subcutaneous glucose concentration, B is the blood glucose concentration, A is the surface area of the region surrounding the sensor, k m is a mass transfer coefficient, K m is a Michaelis-Menten constant, and k r ′ is the reaction rate constant for uptake of glucose by the subcutaneous tissue.
Claim 2
Dependent Claim 170 words
A process for determining glucose concentration in blood, comprising: determining, from a sample of subcutaneous fluid, a subcutaneous glucose concentration, and from the subcutaneous glucose concentration, a glucose concentration in blood by calculation (i) based on a model accounting for mass transfer of the glucose from blood to a subcutaneous region and uptake of the glucose by subcutaneous tissue, and (ii) utilizing a regularization technique in the calculation, wherein the blood glucose concentration is determined from the subcutaneous glucose concentration using the relationship:  S  t = k m  A  ( B - S ) - Vk r ′  S K m + S ′ where V is the volume of the sensor, S is the subcutaneous glucose concentration, B is the blood glucose concentration, A is the surface area of the region surrounding the sensor, k m is a mass transfer coefficient, K m is a Michaelis-Menten constant, and k r ′ is the reaction rate constant for uptake of glucose by the subcutaneous tissue.
Claim 3
Dependent Claim 30 words
The process of claim 1 , further comprising determining the concentration of the glucose in the subcutaneous fluid using a sensing device comprising an electrochemical sensor having a working electrode.
Claim 4
Dependent Claim 23 words
The process of claim 2 , further comprising subcutaneously implanting the working electrode to generate a signal related to the subcutaneous glucose concentration.
Claim 5
Dependent Claim 29 words
The process of claim 2 , comprising determining the concentration of the glucose in the subcutaneous fluid using the sensing device and a processor coupled to the sensing device.
Claim 6
Dependent Claim 24 words
The process of claim 4 , wherein the processor comprises a display coupled to the processor for displaying the glucose concentration in the blood.
Claim 7
Dependent Claim 45 words
The process of claim 5 , further comprising a transmitter coupled to the electrochemical sensor and a receiver coupled to the processor, wherein the processor and receiver are disposed in a housing adapted for remote reception of signals from the electrochemical sensor via the transmitter.
Claim 8
Dependent Claim 23 words
The process of claim 4 , further comprising an alarm coupled to the processor for alerting a user based on the glucose concentration.
Claim 9
Dependent Claim 23 words
The process of claim 4 , wherein the processor is disposed in a housing adapted for placement on the skin of an animal.
Claim 10
Dependent Claim 103 words
A process for determining analyte concentration in a first body fluid, comprising: obtaining measurements of an analyte concentration in a second body fluid, different from the first body fluid; and determining an analyte concentration estimate in the first fluid from the measurements by minimizing the relation: f[b]=x 2 [b]+λΨ[b], wherein b is a vector representing analyte concentration in the first body fluid, x 2 [b] is a function represented a fit between (a) a model of analyte transfer from the first body fluid to the second body fluid and (b) the measurements, λ is a weighting function, and Ψ[b] is a regularization function.
Claim 11
Dependent Claim 103 words
A process for determining analyte concentration in a first body fluid, comprising: obtaining measurements of an analyte concentration in a second body fluid, different from the first body fluid; and determining an analyte concentration estimate in the first fluid from the measurements by minimizing the relation: f[b]=x 2 [b]+λΨ[b], wherein b is a vector representing analyte concentration in the first body fluid, x 2 [b] is a function represented a fit between (a) a model of analyte transfer from the first body fluid to the second body fluid and (b) the measurements, λ is a weighting function, and Ψ[b] is a regularization function.
Claim 12
Dependent Claim 11 words
The process of claim 9 , wherein the analyte is glucose.
Claim 13
Dependent Claim 21 words
The process of claim 10 , wherein the first body fluid is blood and the second body fluid is subcutaneous fluid.
Claim 14
Dependent Claim 40 words
The process of claim 11 , wherein obtaining measurements of an analyte concentration comprises subcutaneously implanting a working electrode of a glucose sensor into an animal; and determining a subcutaneous glucose concentration from a signal generated at the working electrode.
Claim 15
Dependent Claim 104 words
The process of claim 10 , wherein the model is based on the relationship: V   S  t = k m  A  ( B - S ) -  Vk r ′  S K m + S ′ where V is the volume of the sensor, S is the subcutaneous glucose concentration, B is the blood glucose concentration, A is the surface area of the region surrounding the sensor, k m is a mass transfer coefficient, K m is a Michaelis-Menten constant, and k r ′ is the reaction rate constant for uptake of glucose by the subcutaneous tissue.
Claim 16
Dependent Claim 14 words
The process of claim 9 , wherein Ψ[b] is selected to provide first-order regularization.
Claim 17
Dependent Claim 14 words
The process of claim 9 , wherein Ψ[b] is selected to provides second-order regularization.

References Cited (Backward Citations)

US4953552A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2006-06-16 2006-12-16 2007-06-17 $2000.00 Window Closed / Lapsed
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