Non-invasive transdermal sampling and analysis device incorporating an electrochemical bioassay
Inventors
Snyder, Helena Woodvine • Bhatia, Vikas • Currie, John Frederick • Jachmann, Emil F.
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Assignees
Cambridge Medical Technologies LLC
Member
Cambridge Medical TechnologiesCambridge Medical Technologies (CMT) is pioneering a transformative leap in combat casualty and critical care medicine with its advanced biosensor platform. Originally founded on research funded by DARPA, the Army Research Office (ARO), and Walter Reed Army Institute of Research, CMT’s mission has been clear from the start: develop non-invasive, real-time monitoring of blood chemistry for soldiers in the field. Their breakthrough technology samples subcutaneous interstitial fluid (ISF) painlessly and analyzes it outside the body for key biomarkers—starting with glucose and lactate, and now expanding to include blood pH.
This innovation is especially critical in military medicine, where early detection of hemorrhagic shock, sepsis, and metabolic failure can mean the difference between life and death. Traditional vital signs like heart rate and blood pressure often fail to reveal the severity of internal injuries or compensated shock. CMT’s biosensor platform fills this gap by continuously tracking biochemical indicators that reflect tissue perfusion (lactate), acid-base status (pH/base deficit), and stress response (glucose). These metrics are widely recognized in both civilian and military clinical guidelines as essential for guiding resuscitation and predicting outcomes.
Unlike conventional blood tests that require invasive sampling and lab processing, CMT’s devices—such as the LabPatch and LabClasp—use a proprietary method to extract ISF through the skin without needles. Within seconds, they deliver accurate readings of lactate and glucose, with pH integration underway. This allows medics and clinicians to monitor trends in real time, enabling faster, more informed decisions during trauma care, sepsis management, and evacuation triage.
For combat medics operating in austere environments, this technology is a game-changer. A wearable patch could continuously stream vital biochemical data from a wounded soldier to a handheld device, alerting caregivers to rising lactate or falling pH before traditional signs deteriorate. In emergency departments and ICUs, the same platform could reduce reliance on repeated blood draws, improve response times, and enhance patient outcomes.
CMT’s work aligns directly with the goals of the Department of Defense’s Advanced Medical Monitor (AMM) initiative under the Medical Technology Enterprise Consortium (MTEC). As future combat operations are expected to produce mass casualties and strain medical resources, integrating biochemical monitoring into standard vital sign systems is no longer optional—it’s urgent. CMT’s technology offers a scalable, field-ready solution that brings ICU-level insight to the point of injury.
In summary, CMT is redefining how we monitor and manage shock and sepsis in both military and civilian care. By combining non-invasive ISF sampling with rapid, multi-analyte analysis, their platform empowers caregivers with the data they need—when and where they need it most.
COMPANY BACKGROUND:
EXECUTIVES:
Dr. John Currie, Inventor & Chief Science Officer,
Jack Jachmann, CEO,
¤ James Cooke, CFO.
FUNDING: $30M in investment.
GRANTS: 3 SBIR awards totaling $2M.
EXPERIENCE: 8 years of operation.
INTELLECTUAL PROPERTY: 14 US and international patents.
TEAM: 21 employees.
LOCATIONS: Maryland & California (US), United Kingdom, Japan.
MANUFACTURING: 2 contract chip manufacturers (US and Japan).
CLINICAL TRIALS: 3 hospital sites in Massachusetts, 1 in Minnesota, 1 in Colorado.
FOCUS AREAS: Emergency Medicine, Diabetes, Alcoholism & Addiction.
MARKET: We are one year away from launching our monitor product, which will initially support four analytes, with additional planned analytic capabilities employing the same platform.
Cambridge Medical Technologies (CMT) is pioneering a transformative leap in combat casualty and critical care medicine with its advanced biosensor platform. Originally founded on research funded by DARPA, the Army Research Office (ARO), and Walter Reed Army Institute of Research, CMT’s mission has been clear from the start: develop non-invasive, real-time monitoring of blood chemistry for soldiers in the field. Their breakthrough technology samples subcutaneous interstitial fluid (ISF) painlessly and analyzes it outside the body for key biomarkers—starting with glucose and lactate, and now expanding to include blood pH. This innovation is especially critical in military medicine, where early detection of hemorrhagic shock, sepsis, and metabolic failure can mean the difference between life and death. Traditional vital signs like heart rate and blood pressure often fail to reveal the severity of internal injuries or compensated shock. CMT’s biosensor platform fills this gap by continuously tracking biochemical indicators that reflect tissue perfusion (lactate), acid-base status (pH/base deficit), and stress response (glucose). These metrics are widely recognized in both civilian and military clinical guidelines as essential for guiding resuscitation and predicting outcomes. Unlike conventional blood tests that require invasive sampling and lab processing, CMT’s devices—such as the LabPatch and LabClasp—use a proprietary method to extract ISF through the skin without needles. Within seconds, they deliver accurate readings of lactate and glucose, with pH integration underway. This allows medics and clinicians to monitor trends in real time, enabling faster, more informed decisions during trauma care, sepsis management, and evacuation triage. For combat medics operating in austere environments, this technology is a game-changer. A wearable patch could continuously stream vital biochemical data from a wounded soldier to a handheld device, alerting caregivers to rising lactate or falling pH before traditional signs deteriorate. In emergency departments and ICUs, the same platform could reduce reliance on repeated blood draws, improve response times, and enhance patient outcomes. CMT’s work aligns directly with the goals of the Department of Defense’s Advanced Medical Monitor (AMM) initiative under the Medical Technology Enterprise Consortium (MTEC). As future combat operations are expected to produce mass casualties and strain medical resources, integrating biochemical monitoring into standard vital sign systems is no longer optional—it’s urgent. CMT’s technology offers a scalable, field-ready solution that brings ICU-level insight to the point of injury. In summary, CMT is redefining how we monitor and manage shock and sepsis in both military and civilian care. By combining non-invasive ISF sampling with rapid, multi-analyte analysis, their platform empowers caregivers with the data they need—when and where they need it most. COMPANY BACKGROUND: EXECUTIVES: Dr. John Currie, Inventor & Chief Science Officer, Jack Jachmann, CEO, ¤ James Cooke, CFO. FUNDING: $30M in investment. GRANTS: 3 SBIR awards totaling $2M. EXPERIENCE: 8 years of operation. INTELLECTUAL PROPERTY: 14 US and international patents. TEAM: 21 employees. LOCATIONS: Maryland & California (US), United Kingdom, Japan. MANUFACTURING: 2 contract chip manufacturers (US and Japan). CLINICAL TRIALS: 3 hospital sites in Massachusetts, 1 in Minnesota, 1 in Colorado. FOCUS AREAS: Emergency Medicine, Diabetes, Alcoholism & Addiction. MARKET: We are one year away from launching our monitor product, which will initially support four analytes, with additional planned analytic capabilities employing the same platform.
Publication Number
US-11375931-B2
Publication Date
2022-07-05
Expiration Date
Abstract
Systems and methods are provided for determining levels of a target analyte in a biological sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The at least one disruptor of the transdermal sampling and analysis device may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism.
Core Innovation
Embodiment transdermal sampling and analysis devices may include a substrate, at least one disruptor mounted on the substrate in which the at least one disruptor is configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The electrochemical bioassay may include a first small molecule binding element bound to a surface of at least one of the electrodes, at least one barrier layer covering a remainder of the surface such that the entire surface is either occupied by a bound first small molecule binding element or covered by the barrier layer, and a second small molecule binding element linked to an enzyme, wherein the second small molecule binding element, the linked enzyme, and at least one substrate of the linked enzyme are suspended in a hydrogel on top of the at least one of the electrodes. The summary expressly lists target analytes including cardiac troponin I (cTnI), melatonin, procalcitonin (PCT), heparin-binding protein (HBP), and interleukin-6 (IL-6).
The background identifies that conventional ELISA techniques must be performed through a series soak and wash steps where each component is introduced separately and are generally incompatible with real-time sampling and analysis. The background further states that biosensors using blood droplets are typically painful and inconvenient and require relatively large blood samples, and that conventional biosensors require several steps that are time consuming and may cause contamination or loss of the biological sample. The disclosure describes a one-step transdermal biosensor that enables in situ measurement by disrupting the stratum corneum to collect interstitial fluid and performing an electrochemical bioassay in the device to reduce sample size, reduce potential for contamination, and reduce time required for analysis.
Claims Coverage
There are two independent claims: one device claim and one method claim. The inventive features below extract the principal elements recited in those independent claims.
substrate
a substrate;
localized disruptor
at least one disruptor mounted on the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism;
reservoir for biological sample
a reservoir configured to collect and contain a biological sample;
electrodes
at least two electrodes;
electrochemical bioassay composition
an electrochemical bioassay configured to determine levels of a target analyte in the biological sample, wherein the electrochemical bioassay comprises: a first small molecule binding element bound to a surface of at least one of the electrodes; at least one barrier layer covering a remainder of the surface such that the entire surface is either occupied by a bound first small molecule binding element or covered by the barrier layer, wherein the at least one barrier layer comprises an alginate; and a second small molecule binding element linked to an enzyme, wherein the second small molecule binding element, the linked enzyme, and at least one substrate of the linked enzyme are suspended in a hydrogel on top of the at least one of the electrodes.
target analyte selection
the target analyte is selected from the group consisting of cardiac troponin I (cTnI), melatonin, procalcitonin (PCT), heparin-binding protein (HBP), and interleukin-6 (IL-6).
small molecule binding element types
the first and second small molecule binding elements comprise antibodies, aptamers, or affimers.
linked enzyme and substrates
the linked enzyme is selected from the group consisting of alkaline phosphatase (ALP) and horseradish peroxidase (HRP); and the substrate of the linked enzyme is selected from the group consisting of phenyl phosphate and hydrogen peroxide.
optional electron mediator
the electrochemical bioassay further comprises an electron mediator suspended in the hydrogel, wherein the electron mediator is selected from the group consisting of ferrocene, osmium bipyridine complexes, ruthenium phthalocyanine complexes, quinone, tetrathialfulvalene (TTF), tetracyanoquinodimethane (TCNQ), and thionine.
method steps for analysis
providing a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat is generated by at least one disruptor mounted on a substrate of the transdermal sampling and analysis device; collecting and containing a biological sample within a reservoir of the transdermal sampling and analysis device; and determining levels of the target analyte in the biological sample using an electrochemical bioassay, wherein the electrochemical bioassay comprises: a first small molecule binding element bound to a surface of at least one electrode of the transdermal sampling and analysis device; at least one barrier layer covering a remainder of the surface such that the entire surface is either occupied by a bound first small molecule binding element or covered by the barrier layer, wherein the at least one barrier layer comprises an alginate; and a second small molecule binding element linked to an enzyme, wherein the second small molecule binding element, the linked enzyme, and at least one substrate of the linked enzyme are suspended in a hydrogel on top of the at least one electrode.
biological sample identity
the biological sample is interstitial fluid (ISF).
The independent device and method claims recite a transdermal sampling and analysis system that combines a substrate-mounted localized heat disruptor, a reservoir for collecting a biological sample (notably interstitial fluid), electrodes, and an electrochemical bioassay in which a first small molecule binding element and an alginate-containing barrier layer occupy the electrode surface while a second small molecule binding element linked to an enzyme with its substrate (and optionally a mediator) are suspended in a hydrogel above the electrode, and the method claim recites providing localized heat, collecting the sample, and determining analyte levels with that bioassay.
Stated Advantages
One-step in situ measurement enabling real-time point-of-care analysis.
Smaller biological sample required, with reduced potential for contamination and reduced time required to obtain and perform analysis.
Amperometric electrochemical detection offers simplicity, portability, rapid response, high specificity, low cost, and adequate sensitivity for point-of-care testing.
A single device that performs disrupting the skin, collecting biological samples, reacting with a biologically reactive element, and sensing signals reduces multi-step handling.
Documented Applications
Detection of cardiac troponin I (cTnI) in interstitial fluid for early detection or prevention of acute myocardial infarction (AMI).
Measurement of melatonin in body fluid for monitoring sleep patterns and evaluating pineal function.
Detection of bacterial infection biomarkers including procalcitonin (PCT), heparin-binding protein (HBP), and interleukin-6 (IL-6) to distinguish bacterial infections and measure infection severity.
Analysis of cortisol in interstitial fluid to indicate levels of physical or mental stress.
General detection of medically relevant biomarkers in a transdermal sampling and analysis device for widespread clinical applications.
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