Methods of manufacture to optimize performance of transdermal sampling and analysis device
Inventors
Vidalis, Joseph J. • Marcanio, Joseph A. • Currie, John Frederick • Snyder, Helena Woodvine • Bhatia, Vikas
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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-12201422-B2
Publication Date
2025-01-21
Expiration Date
Abstract
Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.
Core Innovation
Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. The methods include forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode, and include forming at least one of the electrodes on each of the base and the lid and forming a recessed second spacer layer over the channel support structures to separate the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.
The invention addresses shortcomings of conventional sampling and sensing by producing a transdermal sampling and analysis device with increased accuracy of the glucose sensing through a manufacture process that results in a more uniform layer of analyte sensing reagent and by implementing channel and reservoir configurations that prevent the analyte sensing reagent from blocking the flow through channels of a collected sample to be analyzed. The methods and apparatus enable non-invasive transdermal collection and in situ analysis to reduce contamination risk and reduce required sample volumes and process steps.
Claims Coverage
The patent includes two independent claims (claims 1 and 5). The main inventive features relate to (1) base and lid structures with electrodes and channel support structures, (2) forming a lid conductive material layer patterned to form at least a second electrode, (3) attaching the lid via adhesive on channel support surfaces to form channels in a reservoir, and (4) a reservoir geometry comprising a circular collection portion with a surrounding sensing chamber.
forming a base structure with at least a first electrode and a plurality of channel support structures
forming a base structure with at least a first electrode and a plurality of channel support structures
forming a lid structure by depositing and patterning a lid conductive material layer to form at least a second electrode
depositing a conductive material layer on a lid substrate to create a lid conductive material layer; and patterning the lid conductive material layer to form at least a second electrode
attaching the lid to the base using adhesive on surfaces of the channel support structures to form channels
attaching the lid structure to the base structure using an adhesive material on surfaces of the plurality of channel support structures, wherein attaching the lid structure to the base structure forms a plurality of channels in a reservoir between the plurality of channel support structures
reservoir geometry with circular collection portion and surrounding sensing chamber
the reservoir comprises a circular collection portion configured to collect a biological sample obtained through permeable skin barrier cells, and a sensing chamber portion configured to receive the biological sample from the circular collection portion, wherein the sensing chamber portion surrounds a periphery of the circular collection portion, and wherein the at least first electrode and the at least second electrode are located proximate to the sensing chamber portion
forming a lid having a plurality of channel support structures on the lid
forming a lid structure configured to be positioned above the at least first electrode, wherein the lid structure has a plurality of channel support structures; and attaching the lid structure to the base structure using an adhesive material on surfaces of the plurality of channel support structures
The independent claims principally cover methods of assembling a transdermal sampling and analysis device by forming electrode-bearing base and lid structures, creating channel support structures that define channels upon adhesive attachment of the lid to the base, and providing a reservoir formed as a circular collection portion with a surrounding sensing chamber with electrodes proximate to the sensing chamber.
Stated Advantages
Increased accuracy of the glucose sensing resulting from a manufacture process that results in a more uniform layer of analyte sensing reagent.
Channel and reservoir configurations that prevent the analyte sensing reagent from blocking flow through channels of a collected sample to be analyzed.
Making the spacer/channel support structures physically independent and separable from the sensing electrode to improve device performance.
Separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.
Enables safe and non-invasive transdermal sampling with minimal injury or sensation and a single-step collection and analysis to minimize contamination and reduce required sample volume and time.
Documented Applications
Non-invasive, one-step home monitoring glucose biosensor for in situ measurement of glucose concentration from interstitial fluid collected from capillary-like channels of the skin.
Analyzing analytes such as glucose and lactate using enzymatic biologically reactive elements and electrochemical detection.
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; and gene therapy.
Analyzing biological samples that have already been collected from food, water, air, whole blood, urine, saliva, chemical reactions or cultures.
Delivering substances transdermally into capillary-like channels of the skin by loading substances on the device for transdermal delivery.
Use with an applicator device and system for applying the transdermal sampling and analysis device to the skin and for processing and transmitting sensed data.
Interested in licensing this patent?