Transdermal sampling and analysis device

Inventors

Currie, John F.Marcanio, Joseph A.Vidalis, Joseph J.

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Assignees

Cambridge Medical Technologies LLC

Member
Cambridge Medical Technologies
Cambridge Medical Technologies

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-9451913-B2

Patent

Publication Date

2016-09-27

Expiration Date


Abstract

Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir and transport the biological samples to a sensing chamber. The sensing chamber may contain at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.

Core Innovation

Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device, collect the biological samples in a reservoir and transport the biological samples to a sensing chamber containing at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.

The various embodiment methods and apparatus allow for a safe and non-invasive transdermal extraction of biological samples using a disruptor unit to generate a localized heat that alters the permeability of the stratum corneum without damaging the stratum corneum so that interstitial fluid may flow and be collected for analysis. The various embodiment methods and apparatus implement channel and reservoir configurations which assist in the delivery of the collected samples to biologically reactive elements for sensing of certain properties of the collected samples.

Claims Coverage

Independent claims identified: 1, 15, and 22. The following extracts the main inventive features recited in those independent claims.

Disruptor configured to generate a localized heat

At least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering the permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat causes capillary-like channels between disrupted cells in the stratum corneum.

Substantially circular reservoir configured to collect biological sample

A reservoir configured to collect and contain a biological sample that is obtained through the capillary-like channels, wherein the reservoir is substantially circular.

Sensing chamber intersecting reservoir with tapered smooth surface and channel array

A sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a tapered smooth surface, and wherein the sensing chamber comprises a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10:1.

Biological sensing element with at least two sensing electrodes

A biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate, wherein the biological sensing element is configured to determine the levels of an analyte in the biological sample, wherein the sensing chamber is configured to contain the biological sample around the at least two sensing electrodes.

Circular sensing chamber surrounding reservoir periphery

A circular sensing chamber surrounding a periphery of the reservoir, the sensing chamber comprising a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 3:1, and a biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate configured to determine levels of an analyte in the biological sample.

Sensing chamber intersecting reservoir at a sharp cornered surface

A sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a sharp cornered surface, and wherein the sensing chamber comprises a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10:1, together with a biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate.

The independent claims center on three core device concepts: a disruptor that generates localized heat to create capillary-like channels in the stratum corneum; a substantially circular collection reservoir coupled to a sensing chamber; and sensing chambers with defined channel-support arrays (including tapered or circular configurations and specified channel aspect ratios) that contain biologically coated electrodes for analyte determination.

Stated Advantages

Provides safe and non-invasive transdermal extraction of biological samples.

Obtains and analyzes transdermally extracted biological samples with minimal injury or sensation to the subject.

Enables the entire process—disrupting skin cells, collecting biological samples, reacting with a biologically reactive element, and sensing—in a singular device, reducing contamination risk and time.

Permits accurate real-time analysis of very small amounts of biological samples, requiring a smaller biological sample volume.

Reduces risks associated with invasive sampling, such as pain, infection, and hemorrhage (as compared to conventional invasive tissue extraction techniques).

Documented Applications

Monitoring for viability and functionality of organs and tissues prepared and stored for surgical implantations.

Monitoring entire chemical panels for individuals, patients, or populations at risk.

Monitoring for critical care, shock, trauma and resuscitation.

Monitoring for chronic critical diseases.

Monitoring for early detection of diseases.

Monitoring for response to therapeutic treatments.

Use in gene therapy.

Analyzing biological samples already collected from food, water, air, whole blood, urine, saliva, chemical reactions or cultures.

Monitoring glucose levels for diabetics (glucose sensing described throughout the document).

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