Flexible apparatus and method for monitoring and delivery
Inventors
Assignees
Cambridge Medical Technologies LLC
Publication Number
US-8333874-B2
Publication Date
2012-12-18
Expiration Date
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Abstract
The present invention generally relates to a system and method that co-locates in a small flexible, configurable system and multi-level substrate sampling, rapid analysis, bio-sample storage and delivery functions to be performed on living tissues or matter obtained from living organisms. The types of the sampling may include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical sampling. In general, the analysis performed at the point of sampling measures the sample taken and records its value. The bio-sample storage function encapsulates a small sample of analyte and preserves it for subsequent examination or analysis, either on the organism by the system or at a remote location by an independent analysis system. Once stored, the sample can provide a record of a biological state at the precise time of sampling. The delivery at the point of sampling can include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical stimuli.
Core Innovation
The present invention generally relates to a system and method that co-locates in a small flexible, configurable system multi-level substrate sampling, rapid analysis, bio-sample storage and delivery functions to be performed on living tissues or matter obtained from living organisms. The types of the sampling may include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical sampling, and the analysis performed at the point of sampling measures the sample taken and records its value.
The bio-sample storage function encapsulates a small sample of analyte and preserves it for subsequent examination or analysis, either on the organism by the system or at a remote location by an independent analysis system. The delivery at the point of sampling can include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical stimuli and the results of the measurements may provide a quantitative snapshot at the instant of sampling that can report a possible disease state and enable intervention.
The disposable sampling part of the system may be mechanically flexible and made of multiple thin layers so as to deform to take the shape of the tissue to be monitored and adhere to it while remaining minimally intrusive. The system and all of its constituent parts is configurable as to the positioning of the sampling on the organism, the number and variety of measurement targets, the type and invasiveness of sampling, the storage and modification of samples, and the frequency, redundancy, recording and reporting of individual measurements.
Claims Coverage
This section identifies four independent inventive features claimed in the patent.
Flexible sensor with micro-heater and electrodes
A sensor comprising: a flexible substrate; a micro-heater formed on the surface of the flexible substrate, wherein the micro-heater is configured to repeatedly generate a temperature sufficient to disrupt the stratum corneum without ablating the cells to obtain the biomolecule; a first pair of electrically conductive paths coupled to the micro-heater; a pair of electrodes supported by the flexible substrate and positioned proximate to the micro-heater, the pair of electrodes comprising a reference electrode and a working electrode being electrochemically activated and configured to react with the biomolecule; and a second pair of electrically conductive paths coupled to the reference electrode and the working electrode.
Sensor with external counter electrode
A sensor comprising: a flexible substrate; a micro-heater formed on the surface of the flexible substrate, wherein the micro-heater is configured to repeatedly generate a temperature sufficient to disrupt the stratum corneum without ablating the cells to obtain the biomolecule; a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising a reference electrode and a working electrode being electrochemically activated and configured to react with the biomolecule; and an external counter electrode.
Cantilevered piezoelectric sensor with electrochemical electrodes
A sensor comprising: a flexible substrate comprising a cantilevered beam formed using a piezoelectric material, wherein the cantilevered beam is configured to measure a deformation of the sensor; and a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising a reference electrode and a working electrode being electrochemically activated and configured to react with the biomolecule.
Piezoelectric deformation sensor with external counter electrode
A sensor comprising: a flexible substrate comprising a piezoelectric material configured to measure a deformation of the sensor; a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising a reference electrode and a working electrode being electrochemically activated and configured to react with a biomolecule; and an external counter electrode.
The independent claims cover a flexible sensor architecture combining a surface micro-heater to disrupt the stratum corneum without ablating cells, electrochemically activated working and reference electrodes positioned proximate to the heater, options for external counter electrodes, and piezoelectric detection structures (including cantilevered beams) integrated on a flexible substrate.
Stated Advantages
Co-locates sampling, rapid analysis, bio-sample storage and delivery functions in a small flexible, configurable system.
Provides a quantitative snapshot at the instant of sampling and records values for possible disease-state reporting and intervention.
Minimally intrusive contact that deforms to the shape of tissue to be monitored and adheres to it.
Configurable positioning, number and variety of measurement targets, sampling types, storage and measurement frequency.
Encapsulates and preserves small analyte samples for subsequent on-device or remote analysis.
Documented Applications
Diabetes monitoring and treatment, including sensing of glucose and related analytes and release of drugs such as human insulin from stored cavities.
Resuscitative medicine, including monitoring and treatment in hemorrhagic shock, trauma, and burns.
Detection and treatment of pediatric jaundice through monitoring of bilirubin.
Monitoring of stamina, physical performance, fatigue, and alertness via glucose and lactate sensing and dissolved gas measurements.
Testing tissue viability, performing tissue biopsy analysis, and implant tissue monitoring for viability and functionality before and following surgery.
Early detection of diseases such as cancer and infectious diseases, and monitoring responses to treatment.
Detection and treatment of dental and oral conditions, including sampling of cheek, gum and crevicular fluids for bacteria, viruses, microbial film, inflammation and caries.
Monitoring obesity, diet, exercise, weight, body composition and related hormones and metabolites (e.g., leptin, ghrelin, insulin).
Monitoring cardio- and vascular functions and stroke-related markers, including cardiac biomarkers and inflammatory markers.
Drug discovery and development screening, pharmacokinetic studies, individual dosing, efficacy, safety, toxicity and clinical trials monitoring.
Detecting and treating infectious diseases including influenza, malaria, Dengue fever, HIV and tuberculosis using antibody and enzyme-based sensors and delivery cavities.
Neural interfacing for short-term or long-term interfacing such as prosthetic control and therapeutic response monitoring.
Monitoring animals, crops, water and food supplies for environmental biosecurity and contamination.
Monitoring for substance and drug use and abuse, including nicotine, cotinine, opiates, cocaine and alcohol metabolites.
Drug dosing clinics and individualized dosing management for drugs such as anti-coagulants.
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