Single use analyte sensor
First Claim
1. A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid, said method comprising:
- (a) providing an analyte measuring device, including;
(i) an analyte sensing element, having a sharpened distal end to facilitate introduction into said animal body and further having an indicating electrode, said indicating electrode being adapted to be activated by electric power, and to form a raw analyte measurement when so activated and in contact with said body fluid, in less than two minutes;
(ii) a reference electrode; and
(iii) an electric power, data processing and display device adapted to mate to said analyte sensing element and activate said analyte sensing element by applying electric power to it and adapted to receive said raw analyte measurement and to compute and display a refined analyte measurement, related to said raw analyte measurement;
(b) introducing said analyte sensing element into said animal body subcutaneous soft tissue, thereby placing said indicating electrode into contact with said animal body subcutaneous soft tissue and said body fluid;
(c) activating said analyte sensing element by applying electric power to it, thereby causing said analyte sensing element to form a raw analyte measurement;
(d) receiving said raw analyte measurement in said electric power, data processing and display device and computing and displaying a refined analyte measurement, related to said raw analyte measurement;
(e) removing said indicating electrode from said body soft tissue, within two minutes of said introducing; and
(f) timing steps (b), (c) and (e) so that said analyte sensing element is activated for at least part of the time it is, at least in part, dwelling in said subcutaneous soft tissue.
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Accused Products
Abstract
A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid. The method comprises, introducing a portion of an analyte-measuring device into the subcutaneous soft tissue. The analyte-measuring device includes an analyte sensing element, having a sharpened distal end to facilitate introduction into the animal body. Additionally the sensing element has an indicating electrode that is adapted to be activated by electric power and to form a raw analyte measurement, when it is activated and in contact with the body fluid, in less than two minutes. The sensing device further has a reference electrode and an electric power and display device that is adapted to mate to the analyte-sensing element. The power and display device activates the analyte-sensing element by applying electric power to it. The analyte-sensing element is introduced into the animal body and is activated by the electric power and display device, thereby causing the analyte-sensing element to form a raw analyte measurement. The power and display device forms and displays a second analyte measurement that is related to the raw analyte measurement, within two minutes of the analyte sensing element being introduced into the body.
166 Citations
25 Claims
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1. A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid, said method comprising:
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(a) providing an analyte measuring device, including;
(i) an analyte sensing element, having a sharpened distal end to facilitate introduction into said animal body and further having an indicating electrode, said indicating electrode being adapted to be activated by electric power, and to form a raw analyte measurement when so activated and in contact with said body fluid, in less than two minutes;
(ii) a reference electrode; and
(iii) an electric power, data processing and display device adapted to mate to said analyte sensing element and activate said analyte sensing element by applying electric power to it and adapted to receive said raw analyte measurement and to compute and display a refined analyte measurement, related to said raw analyte measurement;
(b) introducing said analyte sensing element into said animal body subcutaneous soft tissue, thereby placing said indicating electrode into contact with said animal body subcutaneous soft tissue and said body fluid;
(c) activating said analyte sensing element by applying electric power to it, thereby causing said analyte sensing element to form a raw analyte measurement;
(d) receiving said raw analyte measurement in said electric power, data processing and display device and computing and displaying a refined analyte measurement, related to said raw analyte measurement;
(e) removing said indicating electrode from said body soft tissue, within two minutes of said introducing; and
(f) timing steps (b), (c) and (e) so that said analyte sensing element is activated for at least part of the time it is, at least in part, dwelling in said subcutaneous soft tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. An analyte sensing assembly, comprising:
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(a) a durable portion, including a housing having at least one opening;
(b) a magazine, positioned within and connected to said durable portion and having a plurality of longitudinal storage locations;
(c) a plurality of substantially longitudinal analyte sensing elements, each analyte sensing element being stored in a storage location; and
(d) an actuator adapted to controllably move a longitudinal sensing element that is in alignment to a said opening, so that it protrudes out of said opening and, afterwards, to move said longitudinal sensing element back so that it is completely enclosed in said housing. - View Dependent Claims (16, 17, 18, 19)
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20. A method of facilitating the use of an analyte concentration measurement assembly that has at least one analyte sensing element, which is adapted to accept electric power and to be introduced, at least in part, for less than five minutes into an animal body, and which forms an analyte concentration measurement, and an electric power and display unit matingly connected to and responsive to said analyte sensing element, and adapted to supply said analyte sensing element with electric power and to display said analyte concentration measurement, said method comprising:
(a) selling replacement analyte sensing elements, each one adapted to be matingly connected to said electric power and display unit.
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21. A method of facilitating the use of an analyte concentration measurement assembly having at least one magazine loaded with analyte sensing elements that are adapted to be introduced, at least in part and for less than five minutes into an animal body, and producing a raw analyte measurement and further having a durable unit, matingly and conductively connected to and responsive to said raw analyte measurement and adapted to supply each analyte sensing element with electric power and to receive said raw analyte measurement, said method comprising:
(a) selling replacement magazines loaded with analyte sensing units.
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22. A rapid response analyte sensor assembly, comprising:
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(a) an active surface of a material that is subject to oxidation, and produces an oxidation current when exposed to oxygen, and that also produces an analyte current when exposed to said analyte, said active surface also producing a raw analyte measurement, that is related to both said oxidation current and said analyte current; and
(b) a data analysis unit electrically connected to said active surface, said unit configured to begin a timing process upon first sensing a current at said active surface and providing a refined analyte measurement by correcting said raw analyte measurement reading taken at a first time subsequent to said first sensing of said current by subtracting out a quantity representing a portion of said raw analyte measurement due to said oxidation current expected to exist at said first time.
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23. A rapid response, briefly indwelling, analyte sensor assembly, adapted to provide a reading of an analyte concentration within 20 seconds of being introduced into an animal body.
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24. A rapid response, single use analyte sensor, adapted to measure an analyte concentration in blood of a patient having skin having an outer surface, said sensor comprising:
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(a) a lancet;
(b) a blood trapping structure, adapted to trap blood on said skin outer surface;
(c) an electrochemical analyte measurement system adapted to measure an analyte concentration in blood that is trapped on said surface of said skin, by said blood trapping structure.
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25. A method of measuring the concentration of an analyte in the blood of a patient having skin having an outer surface, said method comprising:
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(a) providing a rapid response, single use analyte sensor, adapted to measure an analyte concentration, said sensor comprising;
(i) a lancet;
(ii) a blood trapping structure, adapted to trap blood on said skin outer surface;
(iii) an electrochemical analyte measurement system adapted to measure an analyte concentration in blood that is trapped on said surface of said skin, by said blood trapping structure (b) puncturing said skin with said lancet and withdrawing said lancet from said skin, thereby permitting blood to flow into said blood trapping structure;
(c) using said electrochemical analyte measurement system to measure said analyte concentration in said blood.
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Specification