Sensor controlled analysis and therapeutic delivery system
First Claim
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1. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
- means for conveying a sample withdrawing electrical current to the skin of a biological subject to obtain desired sample size from the biological subject;
means for terminating said electrical current applied to the biological subject when desired withdrawal sample size has been withdrawn;
means for analyzing said withdrawal sample; and
means for automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample.
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Abstract
A method and apparatus for non-invasively withdrawing and accurately evaluating analytes quickly, painlessly and reliably from a biological subject automatically and controlling subsequent administration of therapeutic agents in response to such analyte sample analysis. Improvements are provided in electro-osmotic sample withdrawal, dosimetry and iontophoretic delivery subsystems, biosensors electrode construction and arrangement, intervenors, mediators, bolus delivery, and related subsystems.
51 Citations
37 Claims
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1. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
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means for conveying a sample withdrawing electrical current to the skin of a biological subject to obtain desired sample size from the biological subject;
means for terminating said electrical current applied to the biological subject when desired withdrawal sample size has been withdrawn;
means for analyzing said withdrawal sample; and
means for automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 21, 23)
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9. An electronic process for controlling electro-osmotic withdrawal of fluid samples by electrical current applied over time to a biological subject, comprising the steps of:
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selecting a total sample size to be withdrawn, in the form of an electrical current-time product, from the biological subject;
automatically varying the time period over which said electrical current is applied by accumulating the electrical current-time product until termination at the selected withdrawal sample volume;
analyzing said withdrawal sample; and
automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
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means for applying a predetermined electrical current to a biological subject over time;
sample volume determining means for establishing the magnitude of the desired total sample volume to be withdrawn from the biological subject, in terms of electrical current-time product;
means for sensing the magnitude of said electrical current and for converting said magnitude to an electrical signal;
means for measuring and accumulating the electrical output of said oscillator over time as an indication of the actual electrical current-time product;
means for comparing said actual electrical current-time product with said desired total sample volume to be withdrawn;
means for terminating said electrical current when said electrical current-time product equals said desired total sample volume to be withdrawn as established by said determining means; and
means for analyzing said withdrawal sample; and
means for automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (20, 22)
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24. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
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means for conveying a sample withdrawing electrical current to the skin of a biological subject;
means for determining the magnitude of said electrical current;
means for controlling the time period over which said electrical current is supplied to the biological subject;
control means for automatically determining the sample size to be extracted from the biological subject;
means for electrically measuring the actual sample quantity withdrawn from the biological subject as a function of said electrical current and time;
means for terminating said electrical current applied to the biological subject when said electrical current-time product equals the desired total withdrawal sample size as established by said control means;
means for analyzing said withdrawal sample; and
means for automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (25, 31, 32)
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26. An electronic process for controlling electro-osmotic withdrawal of fluid samples by electrical current applied over time to a biological subject, comprising the steps of:
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selecting a total sample size to be withdrawn, in the form of an electrical current-time product, from the biological subject;
determining the magnitude of said electrical current;
measuring said electrical current applied to the biological subject and automatically varying the time period over which said electrical current is applied by accumulating the electrical current-time product until termination at the selected withdrawal sample volume;
analyzing said withdrawal sample; and
automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (27)
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28. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
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means for applying a predetermined electrical current to a biological subject over time;
sample volume determining means for establishing the magnitude of the desired total sample volume to be withdrawn from the biological subject, in terms of electrical current-time product;
means for sensing the magnitude of said electrical current and for converting said magnitude to an electrical signal;
oscillator means responsive to said electrical signal for varying the frequency of oscillation as a function of said magnitude of said electrical current;
means for measuring and accumulating the electrical output of said oscillator over time as an indication of the actual electrical current-time product;
means for comparing said actual electrical current-time product with said desired total sample volume to be withdrawn;
means for terminating said electrical current when said electrical current-time product equals said desired total sample volume to be withdrawn as established by said determining means; and
means for analyzing said withdrawal sample; and
means for automatically delivering a therapeutic agent to said biological subject in response to analysis of said sample. - View Dependent Claims (29, 30)
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33. A method of sample withdrawal, assay and consequent therapeutic treatment, comprising the steps of:
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electro-osmotically withdrawing a fluid sample from a subject;
measuring the contents of said fluid sample; and
automatically delivering therapeutic treatment to the subject in response to the results of said measuring step. - View Dependent Claims (34)
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35. A system for sample withdrawal, assay and consequent therapeutic treatment, comprising:
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an electro-osmotic fluid sample withdrawal unit;
a biosensor for measuring the contents of said fluid sample; and
an administration unit for delivering therapeutic treatment automatically in response the measurement of said fluid sample by said biosensor.
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36. In an electronic control system for electro-osmotic withdrawal of fluid samples from a biological subject, the combination comprising:
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means for conveying a sample withdrawing electrical current to the skin of a biological subject to obtain a desired sample size from the biological subject;
means for terminating said electrical current applied to the biological subject when the desired withdrawal sample size has been withdrawn;
means for analyzing said withdrawal sample; and
means for subsequently reversing said electrical current and repeating the sample withdrawal and analysis cycle.
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37. A method for electro-osmotic withdrawal of fluid samples from a biological subject, comprising the steps of:
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conveying a sample withdrawing electrical current to the skin of a biological subject to obtain a desired sample size from the biological subject;
terminating said electrical current applied to the biological subject when the desired withdrawal sample size has been withdrawn;
analyzing said withdrawal sample; and
subsequently reversing said electrical current and repeating the sample withdrawal and analysis cycle.
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Specification