WO2022243869A1 - Échantillonnage de fluide biologique et surveillance pour un suivi approfondi et un test du stress - Google Patents

Échantillonnage de fluide biologique et surveillance pour un suivi approfondi et un test du stress Download PDF

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Publication number
WO2022243869A1
WO2022243869A1 PCT/IB2022/054578 IB2022054578W WO2022243869A1 WO 2022243869 A1 WO2022243869 A1 WO 2022243869A1 IB 2022054578 W IB2022054578 W IB 2022054578W WO 2022243869 A1 WO2022243869 A1 WO 2022243869A1
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WIPO (PCT)
Prior art keywords
analytic
reservoirs
biofluid
collecting region
substrate
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PCT/IB2022/054578
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English (en)
Inventor
Alexandru Paunescu
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Johnson & Johnson Consumer Inc.
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Application filed by Johnson & Johnson Consumer Inc. filed Critical Johnson & Johnson Consumer Inc.
Publication of WO2022243869A1 publication Critical patent/WO2022243869A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/14517—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat

Definitions

  • the present invention relates generally to diagnosis and/or treatment of health conditions, and more particularly relates to methods and apparatuses for collection of biofluids sampling and monitoring for performing enhanced health diagnostics, and may include methods of treatment for conditions.
  • a biological marker also known as a biomarker
  • a biomarker is a defined characteristic that is measured as an indicator of biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.
  • Molecular biology based on genomic, transcriptomic, proteomic or metabolomic biomarkers can assist in developing precise diagnostics, notably in precision medicine. Precision medicine often requires the identification and clinical validation of a large number of biomarkers to predict disease course, to monitor disease evolution, and to monitor and predict patient response to prescribed therapies.
  • a panel of biomarkers is generally known to improve predictive performance over individual biomarkers.
  • single point-in-time analytical panels of biomarkers and biometrics are the standard of care for diagnosing health conditions. Nevertheless, in the case of holistic and systematic healthcare and for individualized therapy and precision medicine, tracking and monitoring, and replacing a single point-in-time test with various types of stress testing is often required.
  • the present invention is directed to wearable apparatuses and methods associated with such apparatuses for non-invasively sampling and monitoring one or more biomarkers for beneficially assessing human health, well-being and performance.
  • Aspects of the invention described and contemplated herein provide solutions, including, for example, a flexible patch adapted to be secured to the human body by a relatively rigid interface affording mechanical support, analytic sites activation/deactivation and analysis of biomarkers collected, logistics to enable wireless communication with an intelligent device (or devices) configured to perform further analysis and/or provide graphical user interface (GUI) functionality.
  • GUI graphical user interface
  • the collecting region is configured to contain the biofluid.
  • Each of the valves is disposed in-line between the central collecting region and a corresponding one of the analytic reservoirs.
  • facilitating includes performing the action, making the action easier, helping to carry the action out, and/or causing the action to be performed.
  • instructions executing on one processor might facilitate an action carried out by instructions executing on another processor, by sending appropriate data or commands to cause or aid the action to be performed.
  • an actor facilitates an action by other than performing the action, the action is nevertheless performed by some entity or combination of entities.
  • Methods described herein, or elements thereof, may be implemented in the form of a computer program product including a computer readable storage medium with computer usable program code for performing the method steps indicated. Furthermore, one or more steps described herein may be implemented in the form of a system (or apparatus) including a memory, and at least one processor that is coupled to the memory and operative to perform exemplary method steps.
  • one or more embodiments of the invention or elements thereof can be implemented in the form of means for carrying out one or more of the method steps described herein; the means can include any of: (i) hardware module(s), (ii) software module(s) stored in a computer readable storage medium (or multiple such media) and implemented on a hardware processor, or (iii) a combination of (i) and (ii); any of (i)-(iii) may be configured to implement the specific techniques set forth herein.
  • FIG. 1 conceptually illustrates a distribution of eccrine glands on the human body along with the relative density of such glands
  • FIGS. 2A and 2B are diagrams conceptually depicting exemplary sweat monitoring patches for providing a single biomarker solution and a multiple biomarker solution, respectively;
  • FIG. 3 conceptually depicts placement of a biosensor on the underside of a watch or other wrist-mounted wearable device
  • FIGS. 4A - 4C conceptually depict an exemplary biosensor device that includes a mechanical switching arrangement for controlling the flow of biofluids in connecting channels of the biosensor;
  • FIG. 5 is a block diagram conceptually depicting at least a portion of an exemplary biosensor device.
  • the apparatuses described herein may include a flexible patch adapted to be secured to the human body by a rigid interface affording mechanical support, analytic sites activation/deactivation, analysis, and logistics to enable wireless communication with an external device (or devices) configured to perform further analysis and/or provide graphical user interface (GUI) functionality.
  • GUI graphical user interface
  • biofluids that may be useful in enabling non- invasive biomarker sampling and analysis
  • sweat is particularly useful in that it has an ability to support convenient monitoring with portable/wearable solutions.
  • biofluids including, for example, urine, tears, saliva and breath condensate, may support monitoring, the description herein will focus on sweat as the biofluid, although other biofluids are contemplated.
  • eccrine glands are of interest due primarily to their ability to collect sweat from the dermis space containing a broad range of biomarkers, including ions (e.g., sodium ions (Na + ), chlorine ions (Cl ), potassium ions (K + ), and ammonia ions (NHC), small molecules (e.g., ethanol, lactate, glucose, cortisol, urea, etc.), and even peptides and cytokines (e.g., neuropeptides, interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor (TNF)-alpha, etc.).
  • ions e.g., sodium ions (Na + ), chlorine ions (Cl ), potassium ions (K + ), and ammonia ions (NHC)
  • small molecules e.g., ethanol, lactate, glucose, cortisol, urea, etc.
  • peptides and cytokines e.g.
  • One of the most important characteristics of the eccrine gland is that it is capable of delivering sweat under a remarkably high hydrostatic pressure (e.g., up to about 72 kN/m 2 ), which makes sampling sweat easier than sampling other biofluids, where active negative pressure is often required.
  • a remarkably high hydrostatic pressure e.g., up to about 72 kN/m 2
  • FIG. 1 conceptually illustrates a distribution of eccrine glands on the human body.
  • the parenthetical numbers or number ranges represent approximate density of the eccrine glands, which can be helpful for comparison purposes to illustrate the variability of the density of the eccrine glands across parts of the body.
  • the highest density of eccrine glands is generally found on the palms and soles, and therefore the palm and/or sole of the body may be desired for sweat collection, however other bodily locations are possible.
  • the methods and devices described herein advantageously overcome one or more of the above-noted problems by providing a novel sweat monitoring apparatus and method which enables monitoring of one or more biomarkers or molecules of interest along a controlled and prescribed span of time with certain sampling frequency and algorithms adapted to the physiology and pathology under test. Clear differentiation between the sampling periods is provided with no or limited crosstalk between sampling “pulses.”
  • the methods and devices described herein further beneficially sample sweat from various places on the body, adapting the method to the specific characteristics. Such sweat sampling is conducted in a natural manner which avoids modifications of the sweat composition that may otherwise be triggered by chemical and electrical perspiration boosting methods.
  • FIGS. 2 A and 2B are diagrams conceptually depicting exemplary biofluid (e.g., sweat) monitoring biosensors, 200 and 250, for providing a single biomarker solution and a multiple biomarker solution, respectively, according to embodiments of the invention.
  • exemplary biofluid e.g., sweat
  • components of the biosensor 200 or 250 are supported on a substrate 201 or 251, respectively, which in one or more embodiments is implemented in the form of a flexible patch adapted to be secured to the skin with an adhesive layer disposed on an underside of the patch.
  • the biosensor patch 201, 251 may be secured to the skin using mechanical means, such as, but not limited to, flexible bands or straps (e.g., rubber, plastic, cloth, leather, etc., with or without Velcro ® or other removable attachment mechanism), patches, etc., to avoid interfering with the physiology of perspiration.
  • the illustrative single biomarker sweat monitoring biosensor 200 includes a central collecting region 202, which preferably functions as a sweat-collecting reservoir.
  • the biosensor 200 further comprises a plurality of analytic reservoirs, 204, 206, 208, 210, 212, 214, 216 and 218.
  • the analytic reservoirs 204 through 218 are configured to perform single biomarker analysis.
  • a plurality of connecting channels 220 included on the biosensor 200 are adapted for conveying a biofluid — sweat, in this scenario — from the central collecting region 202 to the plurality of analytic reservoirs, 204, 206, 208, 210, 212, 214, 216 and 218.
  • the central collecting region 202 is disposed in intimate contact with the skin and is configured having a minimal volume so that the sweat goes preferentially to the analytic reservoirs, 204 through 218.
  • each of the connecting channels 220 preferably includes an in-line valve, VI, V2, V3, V4, V5, V6, V7 and V8, respectively, adapted to be independently activated so that the valves open and close at certain controlled moments in time, consistent with the pursued physiology or pathology.
  • VI, V2, V3, V4, V5, V6, V7 and V8, respectively adapted to be independently activated so that the valves open and close at certain controlled moments in time, consistent with the pursued physiology or pathology.
  • the biosensor 200 may include any number of reservoirs, channels and valves.
  • Activation of the valves VI through V8 can be achieved using various contemplated mechanisms, including, but not limited to, mechanical means (either passive, with channels having different conductivities, or active mechanisms to “pinch/release” the channels) actuated manually through rotating or through depressing an indexing mechanism, electrostatic-actuated valves, and/or phase-changing polymers or gels triggered by a control signal (e.g., an electrical or optical signal) from interface circuitry either self-sufficiently or relying on the biofluid to clear the path.
  • a control signal e.g., an electrical or optical signal
  • the valves comprise microvalves that are fabricated using standard microfluidics techniques, which may involve some form of lithography.
  • An active microvalve is configured to control the flow of a microfluid with a driving device, and a passive microvalve is configured to control the flow of the microfluid typically using back pressure of the microfluid.
  • microvalves can be configured as normally open or normally closed types.
  • the microvalve preferably includes a membrane to control the opening and closing of the connecting channel (e.g., microchannel) to which it is coupled.
  • Various activation mechanisms for the valves may be used, including, but not limited to, electricity-based (e.g., electrostatic actuation, electrochemical actuation, and piezoelectric actuation), magnetism-based (e.g., magnetic actuation and electromagnetic actuation), gas-based (e.g., pneumatic actuation, thermopneumatic actuation), material/biological property-based (e.g., light actuation, pH-sensitive actuation, glucose-sensitive actuation, metal phase transition actuation, including shape memory alloys (SMAs), and biology actuation), and surface acoustic wave (SAW)-based actuation.
  • electricity-based e.g., electrostatic actuation, electrochemical actuation, and piezoelectric actuation
  • magnetism-based e.g., magnetic actuation and electromagnetic actuation
  • gas-based e.g., pneumatic actuation, thermopneumatic actuation
  • material/biological property-based
  • valves VI through V8 comprise microelectromechanical systems (MEMS) microvalves which are easily fabricated and integrated with the microfluidics system on a semiconductor substrate using standard semiconductor processing technology.
  • MEMS microvalves may be actuated in any manner, such as electrostatically or electromechanically actuated.
  • the illustrative multiple biomarker sweat monitoring biosensor 250 includes a central collecting region 252, which preferably functions as a sweat collecting reservoir in a manner consistent with the central collecting region 202 shown in FIG. 2A.
  • the biosensor 250 further comprises a plurality of analytic reservoirs, 254, 256, 258, 260, 262, 264, 266 and 268.
  • each of the analytic reservoirs 254 through 268 may comprise a first analysis site 270, a second analysis site 272, a third analysis site 274, and a fourth analysis site 276.
  • the analytic methods performed in the multiple analysis sites 270 through 276 do not exhibit cross-talk with one another, so that a reaction occurring in a given analysis site does not affect a reaction occurring in another analysis site in the same analytic reservoir. It is to be appreciated that although four analysis sites are shown for each of the analytic reservoirs 254 through 268, embodiments of the invention are not limited to any specific number of analysis sites.
  • a plurality of connecting channels 278 included on the biosensor 250 are adapted for conveying a biofluid — sweat, in this scenario — from the central collecting region 252 to the plurality of analytic reservoirs, 254, 256, 258, 260, 262, 264, 266 and 268.
  • the central collecting region 252 is placed in intimate contact with the skin and is configured having a minimal volume so that the sweat goes preferentially to the analytic reservoirs, 254 through 268.
  • each of the connecting channels 278 preferably includes an in-line valve, VI, V2, V3, V4, V5, V6, V7 and V8, respectively, adapted to be independently activated so that the valves open and close at controlled moments in time, consistent with the pursued physiology or pathology.
  • VI in-line valve
  • V2, V3, V4, V5, V6, V7 and V8, respectively adapted to be independently activated so that the valves open and close at controlled moments in time, consistent with the pursued physiology or pathology.
  • activation of the valves VI through V8 in the biosensor 250 can be achieved using various contemplated mechanisms, including, but not limited to, mechanical means (passive, with channels having different conductivities, or active mechanisms to “pinch/release” the channels), which may be actuated manually through rotating or through depressing an indexing mechanism, electrostatic-actuated valves, and/or phase changing polymers or gels triggered by a control signal (e.g., an electrical or optical signal) from interface circuitry, either self-sufficiently or relying on the biofluid to clear the path.
  • a control signal e.g., an electrical or optical signal
  • valves used in the illustrative biosensors 200 and 250 shown in FIGS. 2A and 2B, respectively, according to one or more embodiments of the invention, can be formed, at least in part, using standard MEMS fabrication techniques.
  • MEMS fabrication may utilize, among other processes, photolithographic patterning, etching, deposition, etc., and conventional semiconductor fabrication tooling. These techniques and tooling will be familiar to those having ordinary skill in the relevant arts.
  • many of the processing steps and tooling used to fabricate MEMS structures and other semiconductor devices are also described in a number of readily available publications, including, for example: P.H.
  • the analytic reservoirs are preferably configured to perform biomarker analysis using any of a plurality of known biomarker assessment techniques, including, but not limited to, colorimetric analysis, spectrometric analysis, magnetic analysis, voltametric analysis, and amperometric analysis, in accordance with one or more embodiments.
  • the analysis sites are functionalized to react only with a targeted analyte or biomolecule and to ignore other analytes even though they are in the same sample fluid.
  • the analysis sites are functionalized with antibodies that, by design, are performing the selection.
  • a biosensor utilizes either functionalized or non-functionalized platforms based on, but not limited to, paper (e.g., surface, lateral or vertical flow), magnetic beads, nanostructured materials (e.g., ZnO), silicon chips with analytic capabilities (e.g., complementary metal-oxide-semiconductor (CMOS), microfluidics, MEMS, optics, etc.), two-dimensional materials (e.g., graphene, transition metal dichalcogenides, etc.) and surface plasmon polariton solutions.
  • paper e.g., surface, lateral or vertical flow
  • magnetic beads e.g., ZnO
  • nanostructured materials e.g., ZnO
  • silicon chips with analytic capabilities e.g., complementary metal-oxide-semiconductor (CMOS), microfluidics, MEMS, optics, etc.
  • CMOS complementary metal-oxide-semiconductor
  • MEMS microfluidics
  • optics
  • the biofluid monitoring solution/device can be placed on any part of the body but, depending on the convenience of the placement, high-flow areas are preferred for monitoring systemic conditions, according to some embodiments.
  • the biofluid monitoring system should be placed in the specific area of the body that is intimately associated with the physiology and pathology of the condition being monitored, with appropriate securing/interfacing means.
  • FIG. 3 conceptually depicts the placement of an illustrative biosensor 300 on the underside surface 302 of a watch 304, or other wrist-mounted wearable product (e.g., smartwatch, tracker, bracelet, etc.), according to one or more embodiments of the invention.
  • the biosensor 300 which may be formed in a manner consistent with the exemplary biosensor devices 200 and 250 shown in FIGS. 2A and 2B, respectively, is configured to collect and monitor sweat collected on the top of the wrist, but the biosensor 300 may be adapted to collect sweat on any location(s) around the wrist.
  • the watch 304 not only provides a convenient support surface and attachment means for the biosensor 300, but can also be configured to provide interfacing functionality, through the wearable product (e.g., watch 304), including notifications and wireless access, as well as additional analytic processing capability. Communication between the biosensor 300 and the watch 304 may be made through one or more wired electrical connections (e.g., electrical contacts and receiving conductive pads, not explicitly shown) or wirelessly (e.g., radio frequency or optical transmitter/receiver included in the biosensor 300 and watch 304, etc.).
  • An important aspect of embodiments of the invention relates to the switching on/off of the analytic reservoirs (e.g., single-biomarker analytic reservoirs 204 through 218 shown in FIG.
  • the flow of biofluid from the collecting region to the individual analytic reservoirs may be selectively controlled by way of valves placed in-line in each of the connecting channels.
  • valves can be individually actuated in various contemplated ways, including mechanical, electrical, chemical/biological, etc., depending on the type of valves employed. This ability to selectively control the flow of biofluids to the plurality of analytic reservoirs advantageously enables the controlled monitoring feature according to embodiments of the invention.
  • Control of flow of biofluids from the central collecting region to one or more analytic reservoirs may be achieved through various methods.
  • One such basic mechanism for controlling the flow of biofluids from the central collecting region to the plurality of analytic reservoirs in the biosensor includes a mechanical switching arrangement.
  • FIGS. 4 A - 4C conceptually depict an exemplary biosensor device 400 that includes a mechanical switching arrangement as a mechanism for manually controlling the flow of biofluids in the connecting channels of the biosensor.
  • the valves are implemented as a “pinch-valve” which comprises a circular or ring-shaped guiding ridge 402 (in FIG. 4A) affixed to the underside of a substantially rigid disk 404 and adapted to engage with a corresponding ring-shaped guiding channel 405 (in FIGS. 4B and 4C) formed in a flexible patch portion of the biosensor device 400.
  • the disk 404 is shown in FIG. 4A detached from the biosensor device 400. Under normal operation, the disk 404 is preferably attached to the biosensor device 400 in a manner which allows the disk to be rotated in relation to the rest of the biosensor.
  • the guiding ridge 402 is received within the guiding channel 405 such that sidewalls of the guiding ridge slidably engage with sidewalls of the guiding channel.
  • the guiding ridge 402 is constructed having a pinch-relief gap 410 which breaks a continuity of the ring-shaped structure.
  • the guiding channel 405 (FIGS. 4B and 4C) is configured to define a thinner wall on top of a plurality of connecting channels 406 in the biosensor 400, so that when rotated into proper position, with the pinch-relief gap 410 of the guiding ridge 402 aligned with a selected one of the individual connecting channels 406, it releases the selected connecting channel 406 from its pinched-off state, thereby allowing the flow of biofluid to a corresponding analytic reservoir 408 via the corresponding connecting channel.
  • Reference to the guiding ridge 402 as being a “pinch-valve” is derived from its “pinching-off ’ functionality.
  • the pinch-relief gap 410 has a width that is preferably configured to be at least as wide as a given one of the connecting channels 406, so that when properly aligned, a corresponding connecting channel passes through the pinch-relief gap 410 substantially unobstructed.
  • the pinch-relief gap 410 be capable of precluding more than one of the connecting channels 406 from being released concurrently, thereby allowing the biofluid to flow to only one of the plurality of analytic reservoirs at any given time.
  • an alignment mark or indicia 414 which may be implemented in the form of a notch or other structure, formed on a top surface or edge of the disk 404 visibly indicating a location of the pinch-relief gap 410 in the guiding ridge 402, as shown in FIG. 4A, and alignment marks 416 formed on the biosensor body (e.g., substrate) indicating locations of the respective analytic reservoirs 408, as shown in FIG. 4B.
  • a functionality of the biosensor embodiment shown in FIGS. 4A - 4C relies on the user manually rotating the disk 404 relative to a body of the biosensor device 400, thereby rotating the guiding ridge/pinch- valve 402 indexing the alignment marks 414/416 for the appropriate analytic reservoir when prompted to do so, such as by a graphic user interface (GUI) on the watch (e.g., 304 shown in FIG. 3) or any other indicator (e.g., audible prompts, lights, etc.).
  • GUI graphic user interface
  • the prompt or prompts may be based on detecting the completion of the analytic process in a prior reservoir and reaching a prescribed time period to enable actuation of the next analytic reservoir.
  • FIG. 5 is a block diagram conceptually depicting at least a portion of an exemplary biosensor device 500 utilizing MEMS valves, according to one or more embodiments of the invention.
  • the biosensor device 500 is in operative communication with a controller 502.
  • the controller 502 may include a microprocessor or other processing device and driver circuitry connected to the microprocessor (not explicitly shown) and is configured to generate a plurality of control signals, each control signal being connected to a corresponding MEMS valve 504 of the biosensor device 500. For clarity purposes, only a subset of the control signals are shown.
  • the control signals generated by the controller 502 are configured to selectively activate the MEMS valves 504 to thereby control the flow of biofluid from the central collecting region to corresponding analytic reservoirs 506 on the biosensor device 500, as will become apparent to those skilled in the art given the teachings herein.
  • the controller 502 may be integrated with the biosensor device 500 (e.g., on the same substrate), or, alternatively, the controller may reside externally to the biosensor device.
  • the construction of the biosensor device includes a sweating amplification feature which is capable of inducing sweat without altering a composition of the biofluid.
  • a sweating amplification feature may be advantageous when the biosensor device is used on places of the body where perspiration is not as abundant.
  • Sweating amplification may be achieved, for example, by providing heat, such as by heating the biosensor assembly, either using a passive mechanism (e.g., iron oxide bags) or using an active mechanism (e.g., heat or thermalized light therapies), or by isolating a larger part of the skin and funneling the additional sweat through microfluidic channels or other means, for example as a surgical glove can achieve.
  • the biosensor device may be integrated with telemetry circuitry for providing wireless communication with an external device (e.g., smartwatch).
  • an external device e.g., smartwatch.
  • identical die are typically fabricated in a repeated pattern on a surface of a semiconductor wafer.
  • Each die includes a device described herein, and may include other structures and/or circuits (e.g., detection circuitry, error correction circuitry, etc.).
  • the individual die may be cut or diced from the wafer, then packaged as an integrated circuit. Any of the exemplary circuits illustrated in the accompanying figures, or portions thereof, may be part of an integrated circuit.
  • Embodiments of the invention are referred to herein, individually and/or collectively, and may be described by using the term “embodiment”.
  • the term “embodiment” is used solely for convenience and without intending to limit the scope of this application to any single embodiment or inventive concept if more than one is, in fact, shown.
  • this disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will become apparent to those of skill in the art given the teachings herein.

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Abstract

Appareil destiné à l'échantillonnage et à la surveillance non invasifs de biomarqueurs pour évaluer la santé, le bien-être et/ou les performances d'un sujet humain comprenant un substrat, une région de collecte centrale disposée sur au moins une partie d'une surface supérieure du substrat, de multiples réservoirs analytiques disposés sur au moins une partie de la surface supérieure du substrat et espacés latéralement de la région de collecte centrale, de multiples canaux de raccordement conçus pour transporter un fluide biologique, contenant des biomarqueurs obtenu à partir du sujet humain, de la région de collecte centrale aux réservoirs analytiques respectifs, et de multiples vannes, chacune des vannes étant disposée en ligne entre la région de collecte centrale et un réservoir correspondant parmi les réservoirs analytiques.
PCT/IB2022/054578 2021-05-18 2022-05-17 Échantillonnage de fluide biologique et surveillance pour un suivi approfondi et un test du stress WO2022243869A1 (fr)

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