Continuous multi-analyte sensor system

Abstract

The various disclosed embodiments relate to analyte sensor configurations. This disclosure may include planar analyte sensors or coaxial analyte sensors. A planar analyte sensor may include one or more insulating and conductive layers stacked on top of each other, as well as a substrate. A coaxial analyte sensor may include one or more wire electrodes co-extruded with the substrate. The continuous analyte monitoring systems discussed herein can be configured to monitor one or more analytes to provide predictive and real-time health data and benefits.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application Serial No. 63 / 321538, filed March 18, 2022, entitled “CONTINUOUS ANALYTE SENSOR SYSTEMS”, and U.S. Application Serial No. 63 / 403,568, filed September 2, 2022, entitled “CONTINUOUS MULTI-ANALYTE SENSOR DEVICES AND METHODS”, and U.S. Application Serial No. 63 / 403,582, filed September 2, 2022, entitled “DEVICES AND METHODS FORMEASURING AN ELECTROPHYSIOLOGICAL SIGNAL AND / OR A CONCENTRATION OF A TARGET ANALYTE IN A BIOLOGICAL FLUID IN VIVO”, and U.S. Application Serial No. 63 / 403,582, filed March 16, 2023, entitled “CONTINUOUS MULTI-ANALYTE SENSOR”. Priority is claimed by U.S. application serial number 63 / 490,589 for “SYSTEMS”, all of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates generally to medical devices, such as analyte sensors, and more specifically, but not in a limiting way, to architectures and manufacturing techniques for analyte sensors. Background Technology

[0004] Various systems can be used to monitor the levels of one or more analytes in one or more subjects. These levels can be monitored and analyzed to determine various aspects of the subject's current health, as well as to predict future health status, including the development and monitoring of conditions such as metabolic status. Therefore, there is a need for improved analyte monitoring systems that can safely, reliably, and effectively provide accurate monitoring of analyte levels in subjects.

[0005] This background is provided to provide a brief context for the following summary and detailed description of the invention. This background is not intended to help define the scope of the claimed subject matter, nor is it intended to limit the claimed subject matter to specific implementations that address any or all of the shortcomings or problems presented above. Summary of the Invention

[0006] This disclosure provides various architectures of analyte sensors, as well as methods for manufacturing and using analyte sensors, such as continuous glucose sensors useful for people with diabetes. For example, analyte sensors can be used to monitor blood glucose levels in people with diabetes. As discussed herein, such analyte sensor architectures can include planar and coaxial structures.

[0007] In the example, the analyte sensor may include a substrate extending between a proximal and a distal portion, a first electrode, a second electrode, and an insulating layer between the first and second electrodes. The substrate may be planar. The first electrode may be a working electrode. The first and second electrodes may each be substantially parallel to the substrate, and both may be planar. The insulating layer may be planar. The first electrode may extend further toward the distal portion of the substrate than the second electrode.

[0008] In the example, the analyte sensor may include a substrate extending between a proximal and a distal portion, a first electrode extending along the substrate between the proximal and distal portions, a second electrode extending along the substrate between the proximal and distal portions, and an insulating portion electrically isolating the first and second electrodes. The substrate may include a cylindrical member having a central axis surrounded by a plurality of concentric circles of increasing radius. The concentric circles are visible through a cross-section of the substrate. The first electrode may be a working electrode. The first and second electrodes may each be aligned with one of the plurality of concentric circles, and the first electrode may extend further toward the distal portion of the substrate than the second electrode.

[0009] In the example, a method of manufacturing an analyte sensor may include aligning one or more insulating layers and one or more conductive layers in an alternating manner, laminating one or more insulating layers and one or more conductive layers together, and exposing at least two electrodes by selectively removing multiple portions of one or more insulating layers.

[0010] In the example, a method of manufacturing an analyte sensor may include co-extruding a substrate and at least two electrode wires into a cylindrical shape to produce an analyte sensor, wherein each of the at least two electrodes is aligned with different concentric circles within the cylindrical shape, unifying the resulting analyte sensor into a plurality of individual analyte sensors, and selectively removing predetermined portions of substrate material on each of the individual analyte sensors to expose sensing areas of the at least two electrodes.

[0011] In the example, the continuous analyte sensor may include: a substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; a first working electrode on the substrate; a second working electrode on the substrate; a reference electrode on the substrate, wherein the first working electrode, the second working electrode, and the reference electrode are all planar electrodes, wherein at least two of the first working electrode, the second working electrode, or the reference electrode are on the first side of the substrate, and any remaining planar electrodes are on the second side of the substrate, wherein at least two of the first working electrode, the second working electrode, and the reference electrode are coplanar with each other; and an interconnect extending through the substrate between the first and second sides, the interconnect being electrically connected to one of the reference electrode, the first working electrode, or the second working electrode.

[0012] In the example, the sensor may include: a substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; a first sensor system on the substrate, the first sensor system being a continuous analyte sensor configured to collect a first type of measurement, wherein the first sensor system includes: a working electrode; a reference electrode on the substrate, wherein both the working electrode and the reference electrode are planar electrodes; and at least one analyte sensing membrane extending over the at least one working electrode; and a second sensor system on the substrate, wherein the second sensor system is configured to collect a second type of measurement different from the first type of measurement.

[0013] In the example, the continuous analyte sensor may include: a planar substrate having a distal portion and a proximal portion connected by a bonding portion, wherein the distal portion and the proximal portion are connected by the bonding portion at an angle between 70 degrees and 110 degrees; a first electrode on the distal portion of the substrate and a first connection pad on the proximal portion, the first electrode and the first connection pad being electrically coupled by a first trace wired through the bonding portion; a second electrode on the distal portion of the substrate and a second connection pad on the proximal portion, the second electrode and the second connection pad being electrically coupled by a second trace wired through the bonding portion; and at least one analyte sensing membrane extending over one or more of the first electrode and the second electrode.

[0014] In the example, a method of fabricating a planar analyte sensor may include stacking a first insulating material, a first conductive material, and a second conductive material on a first side of a substrate; exposing a portion of the first conductive material by selectively removing multiple portions of the first insulating material to form a first electrode; exposing a portion of the second conductive material by selectively removing multiple portions of the first insulating material to form a second electrode; stacking a second insulating material and a third conductive material on a second side of the substrate opposite to the first side; exposing a portion of the third conductive material by selectively removing multiple portions of the third insulating material to form a third electrode; and depositing an analyte sensing film onto either the first electrode, the second electrode, or the third electrode.

[0015] In the example, a method for fabricating multiple analyte sensors may include: producing multiple sensor substrates from a substrate material sheet, wherein each of the multiple sensor substrates is aligned on the substrate material sheet; forming a working electrode and a reference electrode on each of the multiple sensor substrates; and applying an analyte-sensitive film to each of the working electrodes on each of the multiple sensor substrates.

[0016] In the example, a method of manufacturing an analyte sensor may include: aligning a plurality of insulating layers and a plurality of conductive layers in an alternating manner; laminating the plurality of insulating layers and the plurality of conductive layers together; and exposing at least two electrodes by selectively removing a plurality of portions of the plurality of insulating layers.

[0017] In the example, the analyte sensor may include: a sensor substrate; a first electrode mechanically coupled to the sensor substrate; a first electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; a second electrode mechanically coupled to the sensor substrate; a second electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; and an analog front-end (AFE) circuit mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace.

[0018] In the example, the analyte sensor system may include: an analyte sensor comprising: a sensor substrate; a first electrode mechanically coupled to the sensor substrate; a first electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; a second electrode mechanically coupled to the sensor substrate; a second electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; an analog front-end (AFE) circuit mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace; sensor electronics; and a connector electrically coupling the analog front-end circuit to the sensor electronics. Attached Figure Description

[0019] In accompanying drawings that are not necessarily drawn to scale, similar numbers may describe similar parts in different views. Similar numbers with different letter suffixes may represent different instances of similar parts. The accompanying drawings illustrate, by way of example rather than limitation, the various embodiments discussed herein in a general manner.

[0020] Figure 1 This is a diagram illustrating an example of an environment including an analyte sensor system.

[0021] Figure 2 It shows including Figure 1 A diagram illustrating an example of a medical device system using an analytical sensor system.

[0022] Figure 3A This is a diagram of an example analytical material sensor.

[0023] Figure 3B It is along the line where BB passes through. Figure 3A A cross-sectional view of the sensor.

[0024] Figure 3C It is along the CC line that passes through. Figure 3A A cross-sectional view of the sensor.

[0025] Figure 3D It is along the line DD passes through Figure 3A A cross-sectional view of the sensor.

[0026] Figures 4A to 4G A single-sided coplanar analyzer sensor assembly is shown according to an example.

[0027] Figures 5A to 5K A single-sided stacked analyzer sensor assembly is shown according to an example.

[0028] Figures 6A to 6E A biplane, coplanar, unconnected analyte sensor is shown as an example.

[0029] Figures 7A to 7I An analyte sensor with biplane coplanar connection is shown according to an example.

[0030] Figures 8A to 8F An analyte sensor with biplane coplanar connection is shown according to an example.

[0031] Figure 9 A method for manufacturing a coplanar analyzer sensor assembly is shown according to an example.

[0032] Figures 10A to 10B A method for manufacturing a multilayer coplanar analyzer sensor assembly is shown according to an example.

[0033] Figures 11A to 11C A method for manufacturing a coplanar analyzer sensor assembly is shown according to an example.

[0034] Figure 12 A method for manufacturing a coplanar analyzer sensor assembly is shown according to an example.

[0035] Figure 13 A method for manufacturing a coplanar analyzer sensor assembly is shown according to an example.

[0036] Figures 14A to 14D A method for scraping a coplanar analyzer sensor assembly according to an example is shown.

[0037] Figures 15A to 15D A coaxial analyzer sensor assembly with radial wires in an insulating polymer is shown according to an example.

[0038] Figures 16A to 16D A coaxial analyzer sensor assembly with radial wires in an insulating polymer is shown according to an example.

[0039] Figures 17A to 17D A coaxial analyzer sensor assembly with radial wires in an insulating polymer is shown according to an example.

[0040] Figure 18 A coaxial analyzer sensor assembly comprising wires embedded in a photoresist insulating polymer is shown according to an example.

[0041] Figures 19A to 19B A coaxial analyte sensor assembly including a polymer core is shown according to an example.

[0042] Figures 20A to 20B A coaxial analyzer sensor assembly including a conductor core is shown according to an example.

[0043] Figures 21A to 21B A double-sided stacked planar analyzer sensor is shown according to an example.

[0044] Figures 22A to 22B A biplane coplanar analyzer sensor is shown according to an example.

[0045] Figures 23A to 23D A biplane coplanar analyzer sensor is shown according to an example.

[0046] Figures 24A to 24B A biplane coplanar analyzer sensor is shown according to an example.

[0047] Figures 25A to 25E A biplane coplanar analyzer sensor is shown according to an example.

[0048] Figures 26A to 26C A biplane coplanar analyzer sensor is shown according to an example.

[0049] Figures 27A to 27D A biplane coplanar analyzer sensor is shown according to an example.

[0050] Figures 28A to 28C A biplane coplanar analyzer sensor is shown according to an example.

[0051] Figures 29 to 32 The sensor end design based on the example is shown.

[0052] Figure 33 The sensor end design based on the example is shown.

[0053] Figure 34 The sensor end design based on the example is shown.

[0054] Figures 35A to 35B An L-shaped sensor is shown according to an example.

[0055] Figure 36 An L-shaped sensor is shown according to an example.

[0056] Figures 37A to 37D A cubic sensor is shown as an example.

[0057] Figure 38 A cubic sensor is shown on a circuit board according to an example.

[0058] Figures 39A to 39D A method for manufacturing a cubic sensor according to an example is described.

[0059] Figure 40 A flowchart illustrating a method for fabricating a planar analyzer sensor membrane, based on an example, is provided.

[0060] Figure 41 This is a diagram illustrating an example of an analyte sensor system, which includes an analyte sensor electrically coupled to sensor electronics via a connector.

[0061] Figure 42 It is shown Figure 41 A diagram showing an example layout of an analog front-end circuit.

[0062] Figure 43 This is a diagram showing an example arrangement of an analyzer sensor including analog front-end circuitry.

[0063] Figure 44 It is shown Figure 43 Another example of the arrangement of the analyte sensor is shown in the diagram.

[0064] Figure 45 This is a diagram showing another example arrangement of an analyzer sensor including analog front-end circuitry.

[0065] Figure 46 This shows a housing molded onto a sensor substrate. Figure 45 A diagram illustrating an example of an analytical analyte sensor.

[0066] Figure 47 This is a diagram showing another example of an analyte sensor.

[0067] Figure 48 This is a diagram illustrating an example of an analyte sensor system, which includes an analyte sensor electrically coupled to sensor electronics via a non-contact connector.

[0068] Figure 49 This is a diagram showing an arrangement of an analyte sensor system, which includes a sensor substrate on which coils are positioned.

[0069] Figure 50 This is a diagram illustrating another arrangement of an analyte sensor system, which includes sensor electronics via a non-contact connector. Detailed Implementation

[0070] Among other things, this disclosure describes analyte sensors, including planar and cylindrical architectures and fabrication methods for more accurate and reproducible analyte monitoring results. Designs may include multiple sensing surfaces to allow sensing of more than one analyte on a single sensor. In some cases, multiple coatings may be used to ensure proper functioning of the analyte sensor. The analyte sensor can withstand high-speed and high-throughput processes and allows for efficient and flexible electronic device fabrication methods.

[0071] The example analyte sensors described herein can be placed in contact with the host's bodily fluids to measure the concentration of analytes such as glucose in the bodily fluids. In other examples, instead of glucose, or in addition to glucose, two or more analytes as discussed herein can be monitored. In some examples, the analyte sensor is inserted subcutaneously under the host's skin and thereby placed in contact with the interstitial fluid beneath the skin to measure the concentration of the analyte in the interstitial fluid.

[0072] When an analyte sensor is exposed to one or more analytes, a signal is generated and measured. In some examples, the signal is generated via an electrochemical reaction between the analyte sensor and the analyte. This electrochemical reaction causes the analyte sensor to generate a raw sensor signal indicating the concentration of the analyte. In some examples, the analyte sensor may include a working electrode (WE) and a reference electrode (RE). In other examples, the analyte sensor may also include a counter electrode (CE). In the presence of one or more analytes, the electrochemical reaction can cause a current to flow between the working electrode and the counter electrode, where the raw sensor signal may be based on the current. If present, the reference electrode can provide a stable reference potential and conduct a very small current. In some cases, in addition to such measurements obtained via ammeter analysis, measurements may also be taken using a potentiometer.

[0073] In the example two-electrode configuration, the counter electrode can be omitted. In this case, the electrochemical reaction between the analyte sensor and the analyte results in the formation of a current between the working electrode and the reference electrode. Therefore, the reference electrode can conduct current and provide a stable reference potential, just like the counter electrode in a three-electrode configuration. The reference electrode in a two-electrode configuration is sometimes referred to as the counter-reference electrode. In this document, the term reference electrode can be used to refer to the reference electrode in a three-electrode configuration, the counter-reference electrode in a two-electrode configuration, or a similar electrode in other configurations, depending on the example electrode configuration.

[0074] In use, the sensor electronics can apply a bias potential between the working electrode and a reference (e.g., a counter-reference) electrode. In a two-electrode configuration, the applied bias can facilitate an electrochemical reaction between the analyte and the analyte sensor, thereby generating a current between the working electrode and the reference (e.g., a counter-reference) electrode. This current can constitute all or part of the original sensor signal. The bias potential can be positive or negative and can switch between positive and negative values, or between values, depending on one or more analytes being monitored.

[0075] Many analyte sensors are currently manufactured to detect a single analyte, thus potentially requiring multiple sensors or even multiple systems to simultaneously detect and monitor multiple analytes. In some examples, the sensor architecture is associated with the type or number of analytes that can be monitored. Therefore, in some examples as discussed herein, sensor architectures may be configured to detect and monitor two or more analytes simultaneously, overlapping, or in a switching manner. Thus, improved functionality and expanded use of continuous monitoring sensors that detect multiple analytes on a single sensor can be useful. Similarly, in some examples, it may be desirable to have sensor architectures that can be produced quickly and cost-effectively, for example, to meet the needs of healthcare communities, including underserved areas.

[0076] This paper discusses two different categories of analyte sensor architectures: planar and coaxial configurations. Each of these architectures potentially offers several advantages compared to previous wire-based architectures.

[0077] For example, planar analyte sensors can be scaled up for production while still offering flexible geometries. In particular, planar configurations are suitable for high-speed, high-throughput processes, such as wafer-to-wafer or roll-to-roll manufacturing methods. Such flexible electronics manufacturing methods can include photolithography, electroplating, or high-resolution printing methods, such as inkjet printing or screen printing. Planar architectures can also further allow for the sensing of multiple analytes.

[0078] Coaxial analyte sensors can incorporate multiple sensing surfaces, allowing for the efficient sensing of more than one analyte on a single sensor. The production of coaxial or cylindrical sensors can also be easily scalable, as production can be accomplished through extrusion and coating processes such as discrete dispensing, spraying, or dip coating. These methods can be cost- and time-efficient, enabling the rapid production of safe, reliable, and effective continuous analyte and continuous multianalyte monitoring devices. Continuous analyte monitoring systems employing the sensor architecture discussed herein can increase sensor wear time, shorten break-in time, improve accuracy, reduce drift, and increase patient comfort, potentially increasing adherence to pharmacotherapy or other health or nutrition programs, including corrective or preventative measures.

[0079] definition

[0080] As used herein, the terms and phrases “analyte measurement device,” “biosensor,” “sensor,” “sensing area,” and “sensing mechanism” are broad terms and phrases and are intended to give to those skilled in the art their common and conventional meanings (and not limited to their specific or custom meanings), and refer to (but are not limited to) the field of analyte monitoring devices responsible for the detection of a particular analyte or combination of analytes or the transduction of signals associated with a particular analyte or combination of analytes. In one example, such a device is capable of providing specific quantitative, semi-quantitative, qualitative, and semi-qualitative analytical information using biometric elements combined with transduction (detection) elements.

[0081] As used herein, the term "about" allows for a degree of variability in a value or range, for example, within 10%, 5%, or 1% of the limits of said value or range, and includes the exact value or range. As used herein, the term "substantially" means most or the majority, such as at least about 50%, 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, 99.99%, or at least about 99.999% or more, or 100%. As used herein, the term "substantially free of" may mean having no or trace amounts of material such that the amount of material present does not affect the material properties of the composition comprising the material, such that the material comprises about 0 wt% to about 5 wt% of the composition, or about 0 wt% to about 1 wt%, or about 5 wt% or less, or less than or equal to about 4.5 wt%, 4 wt%, 3.5 wt%, 3 wt%, 2.5 wt%, 2 wt%, 1.5 wt%, 1 wt%, 0.9 wt%, 0.8 wt%, 0.7 wt%, 0.6 wt%, 0.5 wt%, 0.4 wt%, 0.3 wt%, 0.2 wt%, 0.1 wt%, 0.01 wt%, or about 0.001 wt% or less, or about 0 wt%.

[0082] As used herein, the terms “adhesion” and “attachment” are broad terms and will be given to those skilled in the art their common and conventional meanings (and not limited to their particular or customary meanings), and refer to, but not limited to, holding, bonding or sticking together, for example, by means of adhesive, bonding, gripping, interpenetration or fusion.

[0083] As used herein, the term "analyte" is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its specific or customary meaning), and refers to, but not limited to, a substance or chemical component in a biological fluid (e.g., blood, interstitial fluid, sweat, cerebrospinal fluid, lymph, or urine) that can be analyzed. Analytes can include naturally occurring substances, man-made substances, metabolites, and / or reaction products. In some examples, the analyte used for measurement by a sensing area, sensing device, and sensing method is glucose. However, other analytes have also been envisioned, including but not limited to: prothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine / uric acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinitol enantiomers; arginase; benzoyl stigmine (cocaine); biotinylate; biopterin; C-reactive protein; carnitine; carnosine; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β-hydroxycholic acid. Cortisol; Creatine anhydride, creatine kinase; Creatine kinase MM isoenzymes; Cyclosporine A; d-Penicillamine; Deethylchloroquine; Dehydroepiandrosterone sulfate; DNA (acetyltransferase polymorphism, alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne malnutrition / Becker's muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA PKU, Plasmodium vivax, 21-deoxycortisol); debutylhalopantide; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acid / acylglycine; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3); fumarate acetylacetase; galactose / gal-1-phosphate; galactose-1-phosphate uridine dihydrogenase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione peroxidase; glycerol, glycocholic acid; glycosyl Hemoglobin; halogenated pantothenate; hemoglobin variants; hexosamine A; human erythrocyte carbonic anhydrase I; 17-α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; β-hydroxybutyrate; ketones; lactate; lead; lipoproteins ((a), B / A-1, β); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin; phytanoic acid / norphytanoic acid; potassium (or other blood electrolytes); progesterone; prolactin; prolysin; purine nucleoside phosphorylase; quinine; reverse triiodothyronine (rT3); selenium; serum pancreatic lipase; sisomicin; sodium; somatostatin C;Specific antibodies (adenovirus, antinuclear antibody, anti-ζ antibody, arbovirus, Orystigma virus, dengue virus, Gynecomastia mesenae, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalis, Helicobacter pylori, hepatitis B virus, herpes simplex virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, Leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, myoglobin, Onchocerca salina, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory...) Analytes include: Dyscythema syncytialis virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma krusei / Trekkirche, vesicular stomatitis virus, Wuch. bancroftian nematodes, and yellow fever virus; specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; leukocytes; and zinc protoporphyrin. In some examples, naturally occurring salts, sugars, proteins, fats, vitamins, and hormones in blood or interstitial fluid may also constitute analytes. Analytes can be naturally present in biological fluids, such as metabolites, hormones, antigens, and antibodies. Alternatively, the analyte may be introduced into the body, such as contrast agents for imaging, radioactive isotopes, chemical reagents, synthetic blood based on fluorocarbons, or drugs or drug compositions, including but not limited to insulin; ethanol; cannabis (cannabinol, tetrahydrocannabinol, hemp); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (cracked cocaine); stimulants (amphetamine, methamphetamine, methylphenidate, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); Sedatives (barbiturates, methimazole, tranquilizers such as diazepam, nitrazepam, metronidazole, tranxene, methylphenidate, tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, piodine, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, percocet, percodan, tussionex, fentanyl, darvon, talwin, lomotil); specialty drugs (fentanyl, meperidine, amphetamine, methamphetamine and analogues of phencyclidine, e.g., ecstasy); anabolic steroids;And nicotine. Metabolites of drugs and drug compositions are also expected analytes. Analytes produced in the body, such as neurochemicals and other chemicals, such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), serotonin (5HT), and 5-hydroxyindoleacetic acid (FHIAA), as well as histamine, can also be analyzed.

[0084] As used herein, the term “bioactive agent” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but not limited to) any substance that has an effect on or elicits a response in living tissue.

[0085] The phrases “biointerface membrane” and “biointerface layer” and “biointerface / drug release membrane” and “biointerface / drug release layer”, which are used interchangeably herein, are broad terms and will be given to those skilled in the art their common and conventional meanings (and not limited to specific or custom meanings), and refer to (but are not limited to) a permeable membrane or layer used as an interface between host tissue and an implantable device.

[0086] As used herein, the phrase “barrier cell layer” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but is not limited to) part of a foreign body reaction that forms a monolayer of cells (e.g., macrophages and foreign body giant cells) that substantially block the transport of molecules and other substances to an implantable device.

[0087] As used herein, the term “biostable” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to, but not limited to, materials that are relatively resistant to degradation by processes encountered in vivo.

[0088] As used herein, the terms “bioabsorbable” or “bioresorbable” are broad terms and will be given to those skilled in the art their common and conventional meaning (and not limited to their particular or custom meaning), and refer to (but not limited to) materials that can be absorbed or lost in a biological system.

[0089] As used herein, the phrase “cellular process” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but is not limited to) cellular pseudopodia.

[0090] As used herein, the phrase “cell attachment” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its specific or custom meaning), and refers to (but is not limited to) the adhesion of cells and / or cellular processes to a material at the molecular level, and / or the attachment of cells and / or cellular processes to the surface of a microporous material or a macroporous material. An example of a material used in the prior art to promote cell attachment to its porous surface is BIOPORE, sold by Millipore (Bedford, Mass.). TM Cell culture support, and as described in U.S. Patent No. 5,741,330 to Brauker et al.

[0091] As used herein, the term “continuous” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but not limited to) an uninterrupted or continuous portion, domain, coating or layer.

[0092] As used herein, the term “cocontinuous” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but is not limited to) a solid portion or cavity in which a three-dimensional continuous curve can be plotted between the two sides of the membrane.

[0093] As used herein, the term “coaxial” should be interpreted broadly to include a sensor architecture having elements aligned around a core along a shared axis, the core being configured to have circular, elliptical, triangular, polygonal, or other cross-sections, such elements including electrodes, insulating layers, or other elements that can be circumferentially positioned around the core, such as core electrodes or core polymer wires.

[0094] Further examples of continuous analyte sensors can be found, for example, in the following U.S. patents: 8,828,201, Simpson et al.; 9,131,885, Simpson et al.; 9,237,864, Simpson et al.; and 9,763,608, Simpson et al., each of which is incorporated herein by reference in its entirety.

[0095] As used herein, the phrase “continuous analyte sensing” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its specific or custom meaning), and refers to (but not limited to) the period of time during which monitoring of analyte concentration is performed continuously, persistently, and / or intermittently (but regularly), for example from about every 5 seconds or less to about 10 minutes or more, preferably from about 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 35 seconds, 40 seconds, 45 seconds, 50 seconds, 55 seconds, or 60 seconds to about 1.25 minutes, 1.50 minutes, 1.75 minutes, 2.00 minutes, or 2.25 minutes. 2.50 minutes, 2.75 minutes, 3.00 minutes, 3.25 minutes, 3.50 minutes, 3.75 minutes, 4.00 minutes, 4.25 minutes, 4.50 minutes, 4.75 minutes, 5.00 minutes, 5.25 minutes, 5.50 minutes, 5.75 minutes, 6.00 minutes, 6.25 minutes, 6.50 minutes, 6.75 minutes, 7.00 minutes, 7.25 minutes, 7.50 minutes, 7.75 minutes, 8.00 minutes, 8.25 minutes, 8.50 minutes, 8.75 minutes, 9.00 minutes, 9.25 minutes, 9.50 minutes, or 9.75 minutes.

[0096] As used herein, the term “co-planar” or “coplanar” can refer to two or more electrodes or other components on a substrate, wherein the two or more electrodes or other components are substantially located in the same plane.

[0097] As used herein, the term “coupled” can refer to two or more system elements or components being configured to be attached in at least one of the following ways: electrically, mechanically, thermally, operatively, chemically, or otherwise.

[0098] As used herein, the term “removably coupled” can refer to two or more system elements or components that are configured or are configured to be attached electronically, mechanically, thermally, operatively, chemically or otherwise and can be separated without damaging any of the coupled elements or components.

[0099] As used herein, the term “permanently coupled” can refer to two or more system elements or components that are configured or have been electrically, mechanically, thermally, operatively, chemically or otherwise attached, but cannot be decoupled without damaging at least one of the coupled elements or components.

[0100] As used herein, the term “defined edge” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or custom meaning), and refers to (but is not limited to) a distinct, crack-like edge or boundary between layers, domains, coatings, or portions. A “defined edge” is the opposite of a gradual transition between layers, domains, coatings, or portions.

[0101] As used herein, the term “discontinuous” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or customary meaning), and refers to (but not limited to) a disjointed, interrupted or separate portion, layer, coating or domain.

[0102] As used herein, the term “far” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its special or customary meaning), and refers to (but not limited to) a region that is relatively far from a reference point (such as a starting point or attachment point).

[0103] As used herein, the term “domain” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to a specific or custom-designed meaning), and refers to, but is not limited to, a region of a membrane system, which may be a layer, a homogeneous or non-homogeneous gradient (e.g., an anisotropic region of the membrane), or a portion of the membrane. Domains discussed herein may be formed as a monolayer, two or more layers, bilayer pairs, or combinations thereof. As used herein, the term “drift” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to a specific or custom-designed meaning), and refers to (but is not limited to) a gradual increase or decrease over time of a signal independent of changes in the concentration of the analyte in the host system. For example, host postprandial glucose concentration. While not wishing to be bound by theory, drift is believed to be a result of, for example, a localized reduction in glucose transport to the sensor due to cell invasion that surrounds the sensor and forms FBCs. It is also believed that, for example, insufficient interstitial fluid around the sensor can lead to reduced oxygen and / or glucose transport to the sensor. An increase in local interstitial fluid can slow or reduce drift and thus improve sensor performance. Drift can also be a result of sensor electronics or algorithmic models used to compensate for noise or other anomalies that may occur alongside electrical signals in the picoampere range.

[0104] As used interchangeably herein, the terms "drug-release membrane" and "drug-release layer" are broad terms and are intended to be understood by one of ordinary skill in the art for their common and conventional meaning (and not limited to specific or custom meanings), and refer to (but not limited to) a permeable or semi-permeable membrane that is permeable to one or more bioactive agents. In one example, "drug-release membrane" and "drug-release layer" may consist of two or more domains and typically have a thickness of several micrometers or greater. In one example, drug-release layer and / or drug-release membrane is substantially the same as biointerface layer and / or biointerface membrane. Examples of drug-releasing layers and drug-releasing membranes can be found in pending U.S. Patent Publication No. 2022-0296867, filed March 17, 2022, entitled “DRUG RELEASING MEMBRANE FOR ANALYTE SENSOR,” the entire contents of which are incorporated herein by reference; and in pending U.S. Application No. 17 / 945585, filed March 17, 2022, entitled “DRUG RELEASING MEMBRANE FOR ANALYTE SENSOR,” the entire contents of which are incorporated herein by reference.

[0105] As used herein, the term "electrochemical reaction surface" is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its specific or custom meaning), and refers to (but is not limited to) the surface of an electrode where an electrochemical reaction occurs. In the working electrode, redox substances are generated by an enzymatic reaction of an analyte, and a measurable electron flow can be produced to determine the concentration of the analyte. In some examples of working electrodes, oxidizable substances produced by the reaction of the detected analyte can generate a measurable electron flow. For example, in the detection of glucose, glucose oxidase produces hydrogen peroxide (H₂O₂) as a byproduct. H₂O₂ reacts with the surface of the working electrode to produce two protons (2H⁺), two electrons (2e⁻), and an oxygen molecule (O₂), thereby generating the detected electron flow. In the counter electrode, a reducible substance (e.g., O₂) is reduced on the electrode surface to balance the current generated by the working electrode.

[0106] As used herein, the term “host” is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its particular or customary meaning), and refers to (but is not limited to) a mammal, preferably a human.

[0107] As used herein, the terms “interfering substance” and “interfering agent” are broad terms and will be given to those skilled in the art their common and conventional meanings (and not limited to their specific or custom meanings), and refer to (but not limited to) effects and / or substances that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte measurement. In one example of an electrochemical sensor, an interfering substance is a compound having an oxidation potential that overlaps with that of the analyte to be measured.

[0108] The term “in vivo” refers, without limitation, to the portion of a device (e.g., a sensor) that is suitable for insertion into and / or present within the living body of a host.

[0109] The term "extracorporeal" refers to a portion of a device (e.g., a sensor) that is suitable to be retained in and / or present outside the living host.

[0110] As used herein, the phrase “membrane system” is a broad term and will be given its common and conventional meaning (and not limited to a specific or custom meaning) to those skilled in the art, and refers to, but not limited to, a permeable or semi-permeable membrane consisting of two or more domains and typically of a thickness of several micrometers or greater, which is permeable to oxygen and optionally permeable to, for example, glucose or another analyte. In one example, the membrane system comprises immobilized glucose oxidase, which enables a reaction between glucose and oxygen, thereby allowing the measurement of glucose concentration. As used herein, the term “noise” is a broad term and is used in its common meaning, including but not limited to signals detected by a sensor or sensor electronics that are independent of analyte concentration and may cause degraded sensor performance. One type of noise has been observed during the first few hours after sensor insertion (e.g., from about 2 hours to about 24 hours). After the first 24 hours, the noise may disappear or decrease, but in some hosts, the noise may persist for about three to four days. In some cases, predictive modeling, artificial intelligence, and / or algorithmic means can be used to reduce noise. In other cases, noise can be reduced by addressing immune response factors associated with the presence of the implanted sensor, for example, using a drug delivery layer having at least one bioactive agent. For example, noise can be determined for one or more exemplary biosensors as disclosed in this invention, and then compared qualitatively or quantitatively. For instance, obtaining a raw signal time series with fixed sampling intervals (in pA) can be achieved by, for example, by applying a third-order low-pass digital Chebyshev Type II filter to obtain a smoothed version of the raw signal time series. Other smoothing algorithms can be used. At each sampling interval, an absolute difference in pA can be calculated to provide a smoothed time series. This smoothed time series can be converted to mg / dL (“noise” units) using a glucose sensitivity time series in pA / mg / dL, where the glucose sensitivity time series is derived using a mathematical model between the raw signal and a reference blood glucose measurement (e.g., obtained from a blood glucose meter). Optionally, the time series can be aggregated as needed, for example, by hour or day. Comparison of corresponding time series between different exemplary biosensors having the drug release layer and one or more bioactive agents disclosed in this invention provides a qualitative or quantitative determination of noise improvement.

[0111] As used herein, the terms “operably connected,” “operably coupled,” and “operably linked” are broad terms and will be given to those skilled in the art their common and conventional meanings (and not limited to their specific or custom meanings), and refer to, but not limited to, one or more components linked to another in a manner that facilitates signal transmission between the components. For example, one or more electrodes may be used to detect an analyte in a sample and convert that information into a signal; that signal can then be transmitted to a circuit. In this example, the electrodes are “operably linked” to an electronic circuit.

[0112] The terms “optional” or “optionally” mean that the event or situation described below may or may not occur, and the description includes instances where the event or situation occurs and instances where the event or situation does not occur.

[0113] As used herein, the term "planar" is broadly interpreted to describe a sensor architecture having a substrate including a first side and a second side, and a plurality of elements disposed on one or more sides of the substrate, which may or may not be electrically coupled or otherwise coupled, wherein the elements may include conductive or insulating layers or elements configured to operate as circuits. For example, a planar electrode has a generally flat or horizontal surface.

[0114] As used herein, the term "proximate" is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to its specific or custom meaning), and refers to (but is not limited to) the spatial relationship between various elements compared to a particular reference point. For example, some examples of devices include membrane systems with a biointerface layer and an enzyme layer. If the sensor is considered the reference point and the enzyme layer is positioned closer to the sensor than the biointerface layer, then the enzyme layer is closer to the sensor than the biointerface layer.

[0115] As used herein, the phrase "processor module" and the term "microprocessor" are broad terms and will be given to those skilled in the art their common and conventional meanings (and not limited to specific or custom meanings), and refer to (but are not limited to) a computer system, state machine, processor, etc., designed to perform arithmetic or logical operations using logic circuitry that responds to and processes the basic instructions that drive the computer. As used herein, the term "semi-continuous" is a broad term and will be given to those skilled in the art its common and conventional meanings (and not limited to specific or custom meanings), and refers to (but is not limited to) a portion, coating, domain, or layer comprising one or more continuous and discontinuous portions, coatings, domains, or layers. For example, a coating positioned around, but not about, the sensing area is "semi-continuous."

[0116] As used herein, the term "sensing membrane" is a broad term and will be given to those skilled in the art its common and conventional meaning (and not limited to a particular or custom meaning), and refers to (but is not limited to) a permeable or semi-permeable membrane that may comprise one or more domains in a membrane system and is composed of a material having a thickness of several micrometers or greater, and is permeable to reactants and / or co-reactants used to determine the analyte of interest. For example, a sensing membrane may contain immobilized glucose oxidase, which catalyzes an electrochemical reaction with glucose and oxygen to allow for the measurement of glucose concentration.

[0117] Analyte sensor system

[0118] Figure 1 This is a diagram illustrating an example of an environment 100 including an analyte sensor system 102 configured to continuously monitor two or more analytes. The analyte sensor system 102 may be coupled to a host 101, which may be a human patient. In some cases, the host may suffer from a transient or permanent diabetes condition or other health conditions that make analyte monitoring useful. The analyte sensor system 102 may include an analyte sensor 104 configured to detect one or more analytes. In some examples, the analyte sensor 104 may include a glucose sensor configured to measure glucose concentration in the host 101. The analyte sensor 104 may contact the analyte on the host 101 in any suitable manner. In some cases, the analyte sensor 104 may be completely implanted under the skin of the host 101. In some examples, the analyte sensor 104 may be worn on the body of the host 101. Moreover, in some examples, the analyte sensor 104 may be a percutaneous device (e.g., a device including a sensor such as the analyte sensor 104 located at least partially under or within the skin of the host).

[0119] In the example, the glucose detected can be D-glucose. However, any stereoisomer or mixture of stereoisomers of glucose, whether in open-chain, cyclic, or mixed forms, can be detected. Figure 1 In some examples, the analyte sensor system 102 may also include sensor electronics 106. In some examples, sensor electronics 106 and analyte sensor 104 may be housed in a single integrated package. In other examples, analyte sensor 104 and sensor electronics 106 may be configured as separate components or modules. For example, the analyte sensor system 102 may include a disposable (e.g., single-use) sensor mounting unit that may include analyte sensor 104, components (e.g., adhesive pads) for attaching analyte sensor 104 to a host, and / or be configured to receive components including... Figure 2The mounting structure of some or all of the sensor electronics units in the sensor electronics 106 shown is illustrated. The sensor electronics units are reusable.

[0120] The analyte sensor 104 can use various methods, including invasive, minimally invasive, or non-invasive sensing techniques (e.g., optically excited fluorescence, microneedles, transdermal glucose monitoring), to provide a raw sensor signal indicating the concentration of the analyte in the host 101. This raw sensor signal can be converted into calibrated and / or filtered analyte concentration data, which is used to provide a useful value (e.g., an estimated blood glucose level) of the analyte concentration to users such as the host or caregivers (e.g., parents, relatives, guardians, teachers, doctors, nurses, or any other individual interested in the health of the host 101).

[0121] In some examples, the analyte sensor 104 may include a continuous glucose sensor. The continuous glucose sensor may be or include a subcutaneous, transdermal (e.g., transdermal), or intravascular device. In some cases, such a sensor or device may cyclically (e.g., periodically or intermittently) analyze sensor data. The glucose sensor can use any glucose measurement method, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoresis, radiometric, immunochemical, and other methods.

[0122] Environment 100 may also include a second medical device 108. The second medical device 108 may be or include a drug delivery device, such as an insulin pump or insulin pen. In some examples, medical device 108 may include one or more sensors, such as another analyte sensor, heart rate sensor, respiration sensor, motion sensor (e.g., accelerometer), posture sensor (e.g., 3-axis accelerometer), acoustic sensor (e.g., to capture ambient sound or sound within the body), oxygen sensor, temperature sensor, or other sensors. Medical device 108 may be wearable, such as on a watch, glasses, contact lens, patch, wristband, ankle strap, or other wearable item, or may be integrated into a handheld device (e.g., smartphone). In some examples, medical device 108 may include a multi-sensor patch that may, for example, detect one or more of the following: analyte levels (e.g., glucose, lactate, insulin, or other substances), heart rate, respiration (e.g., using impedance), activity (e.g., using an accelerometer), posture (e.g., using an accelerometer), skin conductance response, and tissue fluid levels (e.g., using impedance or pressure).

[0123] In some examples, the analyte sensor system 102 and the second medical device 108 communicate with each other. Communication between the analyte sensor system 102 and the medical device 108 can occur via any suitable wired connection and / or via wireless communication signal 110. For example, the analyte sensor system 102 may be configured to communicate using radio frequency (e.g., Bluetooth, Medical Implantable Communication System (MICS), Wi-Fi, Near Field Communication (NFC), Radio Frequency Identification (RFID), Zigbee, Z-wave, or other communication protocols), optical (e.g., infrared), acoustic (e.g., ultrasound), or cellular protocols (e.g., Code Division Multiple Access (CDMA) or Global System for Mobile Communications (GSM)) or via a wired connection (e.g., serial, parallel, etc.).

[0124] In some examples, environment 100 may also include a wearable sensor 130. Wearable sensor 130 may include sensor circuitry (e.g., sensor circuitry configured to detect glucose concentration or other analyte concentration) and communication circuitry, which may be, for example, NFC circuitry. In some examples, information from wearable sensor 130 can be retrieved from wearable sensor 130 using a user device 132, such as a smartphone, configured to communicate with wearable sensor 130 via the wearable sensor's communication circuitry, for example, when the user device 132 is placed near wearable sensor 130. For example, swiping user device 132 on wearable sensor 130 may retrieve sensor data from wearable sensor 130 using NFC or other suitable wireless communication. The use of NFC communication can reduce the power consumption of wearable sensor 130, which can reduce the size of the power source (e.g., battery or capacitor) in wearable sensor 130 or extend the power supply's lifespan. In some examples, wearable sensor 130 may be worn on the upper arm as shown. In some examples, wearable sensor 130 may be additionally or alternatively located on the patient's upper torso (e.g., on the heart or lungs), which may help, for example, detect heart rate, breathing, or posture. Wearable sensor 136 may also be located on the lower extremities (e.g., on the legs).

[0125] In some examples, a sensor array or network may be associated with a patient. For example, one or more of the analyte sensor system 102, medical device 108, wearable device 120 (such as a watch), and additional wearable sensor 130 may communicate with each other via wired or wireless communication (e.g., Bluetooth, MICS, NFC, or any other option described above). The additional wearable sensor 130 may be any of the examples described above with respect to medical device 108. The analyte sensor system 102, medical device 108, and additional wearable sensor 130 on host 101 are provided for illustration and description and are not necessarily drawn to scale.

[0126] Environment 100 may also include one or more computing devices, such as a handheld smart device (e.g., a smart device) 112, a tablet computer 114, a smart pen 116 (e.g., an insulin delivery pen with processing and communication capabilities), a computer 118, a wearable device 120 (such as a watch), or a peripheral medical device 122 (which may be proprietary devices, such as proprietary user devices available from DexCom). Any of these computing devices may communicate with the analyte sensor system 102 via wireless communication signal 110 and may also communicate with a server system (e.g., a remote data center) or a remote terminal 128 via network 124 to facilitate communication with remote users (not shown), such as technical support staff or clinicians.

[0127] Wearable device 120 may include activity sensors, heart rate monitors (e.g., light-based or electrode-based sensors), breathing sensors (e.g., sound-based or electrode-based sensors), location sensors (e.g., GPS), or other sensors.

[0128] In some examples, environment 100 may include server system 126. Server system 126 may include one or more computing devices, such as one or more server computing devices. In some examples, server system 126 is used to collect analyte data from analyte sensor system 102 and / or analyte or other data from multiple other devices, analyze the collected data, generate or apply a general or individualized model of glucose levels, and transmit such analysis, models, or information based thereon back to one or more devices in environment 100. In some examples, server system 126 collects inter-host and / or intra-host adaptation data to generate one or more adaptation features, as described herein.

[0129] Environment 100 may also include a wireless access point (WAP) 138 for communicatively coupling to one or more of the analyte sensor system 102, network 124, server system 126, medical device 108, or any of the aforementioned peripheral devices. For example, WAP 138 may provide Wi-Fi and / or cellular connectivity within environment 100. Other communication protocols such as NFC or Bluetooth may also be used between devices in environment 100.

[0130] Figure 2 It shows including Figure 1 A diagram illustrating an example of an analytical material sensor system 102 in a medical device system 200. Figure 2 In the example, the analyte sensor system 102 may include sensor electronics 106 and sensor mounting unit 290. Figure 2In the example shown, sensor mounting unit 290 may include analyte sensor 104 and battery 292. In some examples, sensor mounting unit 290 may be replaceable, and sensor electronics 106 may include debounce circuitry (e.g., gates with hysteresis or delay) to avoid cyclic execution of power-on or power-off processes, such as when the battery is repeatedly connected and disconnected, or to avoid processing of noise signals associated with battery removal or replacement. Sensor electronics 106 may be configured to continuously monitor two or more analytes. Two or more analytes may be monitored continuously or in an alternating or other mode to, for example, predict and prevent adverse health events such as hypoglycemia, hyperglycemia, or early organ failure.

[0131] Sensor electronics 106 may include electronic components configured to process sensor information, such as raw sensor signals, and generate corresponding analyte concentration values. Sensor electronics 106 may, for example, include electronic circuitry associated with measuring, processing, storing, or transmitting continuous analyte sensor data, including anticipated algorithms associated with the processing and calibration of the raw sensor signals. Sensor electronics 106 may include hardware, firmware, and / or software capable of measuring analyte levels via a glucose sensor. The electronic components may be attached to a printed circuit board (PCB) and may take various forms. For example, the electronic components may take the form of integrated circuits (ICs), such as application-specific integrated circuits (ASICs), microcontrollers, and / or processors.

[0132] exist Figure 2 In the example, sensor electronics 106 may include measurement circuitry 202 (e.g., a voltage regulator) coupled to analyte sensor 104 and configured to cyclically acquire analyte sensor readings using analyte sensor 104. For example, measurement circuitry 202 may continuously or cyclically measure a raw sensor signal indicating the current at analyte sensor 104 between the working electrode and a reverse or reference (e.g., anti-reference) electrode. Sensor electronics 106 may include gate circuitry 294 for gating the connection between measurement circuitry 202 and analyte sensor 104. For example, analyte sensor 104 may accumulate charge during an accumulation period. After the accumulation period, gate circuitry 294 is deactivated, allowing measurement circuitry 202 to measure the accumulated charge. Gating analyte sensor 104 can improve the performance of analyte sensor system 102 by producing a greater signal-to-noise ratio or interference ratio (e.g., because charge accumulates from the analyte reaction, but interfering sources such as acetaminophen present near a glucose sensor do not accumulate or accumulate less charge from the analyte reaction).

[0133] The sensor electronics 106 may also include a processor 204. The processor 204 is configured to retrieve instructions 206 from memory 208 and execute instructions 206 to control various operations within the analyte sensor system 102. For example, the processor 204 may be programmed to control the application of a bias potential to the analyte sensor 104 via a regulator at measurement circuitry 202, interpret the raw sensor signal from the analyte sensor 104, and / or compensate for environmental factors. The processor 204 may also store information in or retrieve information from data storage memory 210. In various examples, data storage memory 210 may be integrated with memory 208 or may be a separate memory circuit, such as a non-volatile memory circuit (e.g., flash RAM).

[0134] Sensor electronics 106 may also include a sensor 212 that can be coupled to processor 204. Sensor 212 may be a temperature sensor, accelerometer, or other suitable sensor. Sensor electronics 106 may also include a power source such as a capacitor or battery 214, which may be integrated into sensor electronics 106, or may be removable, or part of a separate electronics unit. Battery 214 (or other power storage components, such as capacitors) may optionally be recharged via a wired or wireless (e.g., inductive or ultrasonic) recharging system 216. Recharging system 216 may harvest energy from an external or onboard source, or from body temperature (e.g., thermoelectric effect). In various examples, recharging circuitry may include triboelectric charging circuitry, piezoelectric charging circuitry, RF charging circuitry, photoelectric charging circuitry, ultrasonic charging circuitry, thermal charging circuitry, thermal harvesting circuitry, or circuitry that harvests energy from communication circuitry. In some examples, recharging circuitry may use power supplied by a replaceable battery (e.g., a battery provided by the base components) to recharge a rechargeable battery.

[0135] Sensor electronics 106 may also include one or more supercapacitors in the sensor electronics unit (as shown) or sensor mounting unit 290. For example, the supercapacitor may allow energy to be drawn from battery 214 in a highly consistent manner to extend the life of battery 214. After the supercapacitor has delivered energy to the communication circuitry or processor 204, battery 214 may recharge the supercapacitor, making it ready to deliver energy during subsequent high-load cycles. In some examples, the supercapacitor may be configured in parallel with battery 214. Instead of battery 214, the device may be configured to preferentially draw energy from the supercapacitor. In some examples, the supercapacitor may be configured to receive energy from a rechargeable battery for short-term storage and transfer energy to a rechargeable battery for long-term storage.

[0136] The supercapacitor can extend the operating life of battery 214 by reducing strain on battery 214 during high-load cycles. In some examples, the supercapacitor removes at least 10% of the strain from the battery during a high-load event. In some examples, the supercapacitor removes at least 20% of the strain from the battery during a high-load event. In some examples, the supercapacitor removes at least 30% of the strain from the battery during a high-load event. In some examples, the supercapacitor removes at least 50% of the strain from the battery during a high-load event.

[0137] The sensor electronics 106 may also include wireless communication circuitry 218, which may include, for example, a wireless transceiver operatively coupled to an antenna. Wireless communication circuitry 218 may be operatively coupled to processor 204 and may be configured to communicate wirelessly with one or more peripheral devices or other medical devices such as insulin pumps or smart insulin pens.

[0138] exist Figure 2 In one example, the medical device system 200 may also include an optional peripheral device 250. The peripheral device 250 can be any suitable user computing device, such as, for example, a wearable device (e.g., an activity monitor), such as wearable device 120. In other examples, the peripheral device 250 may be… Figure 1 The handheld smart device shown is (e.g., a smartphone or other device such as a proprietary handheld device available from Dexcom), tablet 114, smart pen 116, or dedicated computer 118. In some cases, the medical device system 200 may be incorporated into the Internet of Things, such as by including wearable smart technology. Such wearable smart technology may include, for example, watches, belts, necklaces, earrings, bracelets, headphones, earplugs, or other wearable items.

[0139] Peripheral device 250 may include UI 252, memory circuitry 254, processor 256, wireless communication circuitry 258, sensor 260, or any combination thereof. Peripheral device 250 may not necessarily include... Figure 2 All components shown. Peripheral device 250 may also include a power source, such as a battery.

[0140] For example, UI 252 can be provided using any suitable one or more input / output devices of peripheral device 250, such as a touchscreen interface, a microphone (e.g., for receiving voice commands) or speaker, vibration circuitry, or any combination thereof. UI 252 can receive information (e.g., instructions, glucose values) from a host or another user. UI 252 can also deliver information to a host or other user, for example, by displaying UI elements at UI 252. For example, UI elements may indicate glucose or other analyte concentration values, glucose or other analyte trends, glucose or other analyte alarms, etc. Trends may be indicated by UI elements such as arrows, graphs, charts, etc.

[0141] Processor 256 may be configured to present information to a user or receive input from a user via UI 252. Processor 256 may also be configured to store and retrieve information in memory circuitry 254, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information. Wireless communication circuitry 258 may include a transceiver and an antenna configured to communicate via a wireless protocol such as any wireless protocol described herein. Sensor 260 may include, for example, an accelerometer, a temperature sensor, a position sensor, a biosensor or glucose sensor, a blood pressure sensor, a heart rate sensor, a respiration sensor, or another physiological sensor.

[0142] Peripheral device 250 may be configured to receive and display sensor information that can be transmitted by sensor electronics 106 (e.g., in a customized data packet transmitted to a display device based on its respective preferences). Sensor information (e.g., blood glucose concentration level) or alarms or notifications (e.g., “high glucose level,” “low glucose level,” or “rate of decline alarm”) may be transmitted via UI 252 (e.g., via visual display, sound, or vibration). In some examples, peripheral device 250 may be configured to display or otherwise transmit sensor information while it is being transmitted from sensor electronics 106 (e.g., in a data packet transmitted to a corresponding display device). For example, peripheral device 250 may transmit processed data (e.g., an estimated analyte concentration level that can be determined by processing raw sensor data) such that a device receiving the data does not need to further process the data to determine available information (e.g., the estimated analyte concentration level). In other examples, peripheral device 250 may process or interpret the received information (e.g., to issue an alarm based on glucose values ​​or glucose trends). In various examples, peripheral device 250 may receive information directly from sensor electronics 106 or via a network (e.g., via a cellular or Wi-Fi network, which receives information from sensor electronics 106 or from a device communicatively coupled to sensor electronics 106).

[0143] exist Figure 2 In the example, medical device system 200 may include optional medical device 270. For example, medical device 270 may be used in addition to or in place of peripheral device 250. Medical device 270 may be or include any suitable type of medical or other computing device, including, for example... Figure 1 The illustrated medical device 108, peripheral medical device 122, wearable device 120, wearable sensor 130, or wearable sensor 136. Medical device 270 may include UI 272, memory circuitry 274, processor 276, wireless communication circuitry 278, sensor 280, therapeutic circuitry 282, or any combination thereof.

[0144] Similar to UI 252, UI 272 can be provided using any suitable one or more input / output devices of medical device 270, such as a touchscreen interface, microphone or speaker, vibration circuitry, or any combination thereof. UI 272 can receive information (e.g., glucose values, alarm preferences, calibration codes) from the host or another user. UI 272 can also deliver information to the host or other users, for example, by displaying UI elements at UI 252. For example, UI elements may indicate glucose or other analyte concentration values, glucose or other analyte trends, glucose or other analyte alarms, etc. Trends may be indicated by UI elements such as arrows, graphs, charts, etc.

[0145] Processor 276 may be configured to present information to a user or receive input from a user via UI 272. Processor 276 may also be configured to store and retrieve information in memory circuitry 274, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information. Wireless communication circuitry 278 may include a transceiver and antenna configured to communicate via a wireless protocol (such as any wireless protocol described herein).

[0146] Sensor 280 may include, for example, an accelerometer, temperature sensor, position sensor, biosensor or blood glucose sensor, blood pressure sensor, heart rate sensor, respiration sensor, or other physiological sensor. Medical device 270 may include two or more sensors (or memory or other components), even if... Figure 2 Only one sensor 280 is shown in the example. In various examples, the medical device 270 may be a smart handheld glucose sensor (e.g., a blood glucose meter), a drug pump (e.g., an insulin pump) or other physiological sensor devices, therapeutic devices, or combinations thereof.

[0147] In an example where medical device 270 may include an insulin pump, the pump and analyte sensor system 102 may be in bidirectional communication (e.g., so the pump can request a change in the analyte delivery protocol, such as requesting data points or requesting data on a more frequent schedule), or the pump and analyte sensor system 102 may communicate using unidirectional communication (e.g., the pump can receive analyte concentration level information from the analyte sensor system). In unidirectional communication, glucose values ​​may be incorporated into an advertising message that can be encrypted using a previously shared key. In bidirectional communication, the pump may request the analyte sensor system 102 to share or obtain and share values ​​in response to a request from the pump, and any or all of these communications may be encrypted using one or more previously shared keys. For one or more reasons, the insulin pump may use unidirectional communication with the pump to receive and track analyte (e.g., glucose) values ​​sent from the analyte sensor system 102. For example, the insulin pump may pause or activate insulin administration based on glucose values ​​below or above a threshold.

[0148] In some examples, the medical device system 200 may include two or more peripheral devices and / or medical devices, each receiving information directly or indirectly from the analyte sensor system 102. Because different display devices offer many different user interfaces, the content of the data packets (e.g., the amount, format, and / or type of data to be displayed, alarms, etc.) can be customized for each specific device (e.g., programmed differently by the manufacturer and / or by the end user). For example, now refer to... Figure 1 For example, multiple different peripheral devices can directly communicate wirelessly with sensor electronics 106 (e.g., on-skin sensor electronics 106 physically connected to continuous analyte sensor 104) during a sensor session to enable multiple different types and / or levels of display and / or functions associated with displayable sensor information, or to save battery power in analyte sensor system 102. One or more designated devices can communicate with analyte sensor system 102 and relay (i.e., share) information to other devices directly or via server system (e.g., network-connected data center) 126.

[0149] Analyte sensor membrane

[0150] Figure 3A This is a side view of an example analyte sensor 334 that can be implanted in a host. The mounting unit 314 can be adhered to the host's skin using an adhesive pad 308. The adhesive pad 308 may be formed of a stretchable material and can be removably attached to the skin using an adhesive. An electronics unit 318 may be mechanically coupled to the mounting unit 314. In some examples, the electronics unit 318 and the mounting unit 314 are positioned similarly to... Figure 1 and Figure 2 The sensor electronics 106 and sensor mounting unit 290 are arranged in the manner shown. In some cases, the analyte sensor 334 does not include a separate mounting unit. In some cases, the analyte sensor 334 may be an integrated package. The analyte sensor 334 may be a coaxial sensor configuration. In other examples, the analyte sensor 334 may be a planar configuration.

[0151] Figure 3B When the sensor is configured in a coaxial configuration, it passes through line BB. Figure 3A A cross-sectional view of the sensor. Figure 3B The exposed electroactive surface of at least one working electrode 338 surrounded by a sensing membrane is shown. Generally, the sensing membrane of this disclosure comprises multiple domains or multiple layers, such as interference domain 344, enzyme domain 346, and resistance domain 348, and may include additional domains, such as electrode domains, cell-impermeable domains (not shown), oxygen domains (not shown), drug release membranes 370, and / or biointerface membranes (not shown), as described in more detail below and / or in co-pending U.S. patent applications cited herein. However, it should be understood that sensing membranes for other sensors may be modified within the scope of this disclosure, for example, by including fewer domains or additional domains.

[0152] Figure 3C The image shown is a cross-sectional view of the sensor in planar form. Figure 3C The exposed electroactive surface of at least the working electrode 380 surrounded by a sensing membrane is shown. Similar to... Figure 3B The circular sensor shown can also be a planar sensor, which may include a sensing membrane having multiple layers or domains. For example, a planar sensor may include an interference domain 382, ​​an enzyme domain 384, and a resistance domain 386, as well as other variations of the domains, such as the drug release membrane 388 discussed above.

[0153] In some examples, one or more domains of the sensing membrane are formed of materials such as silicone; polytetrafluoroethylene; polyethylene-co-tetrafluoroethylene; polyolefins; polyesters; polycarbonates; bio-stabilized polytetrafluoroethylene; homopolymers, copolymers, and terpolymers of polyurethanes; polypropylene (PP); polyvinyl chloride (PVC); polyvinylidene fluoride (PVDF); polybutylene terephthalate (PBT); polymethyl methacrylate (PMMA); polyether ether ketone (PEEK); polyurethanes; cellulose polymers; poly(ethylene oxide), poly(propylene oxide), and copolymers and blends thereof; polysulfones and their block copolymers, including, for example, diblock copolymers, triblock copolymers, alternating copolymers, random copolymers, and graft copolymers. Co-pending U.S. Patent Application Serial No. 10 / 838,912 (the entire contents of which are incorporated herein by reference) describes biointerfaces and sensing membrane configurations and materials that can be applied to the sensors disclosed in this invention.

[0154] Sensing membranes can be deposited on the electroactive surfaces of electrode materials using known thin-film or thick-film techniques (e.g., spraying, electrodeposition, impregnation, etc.). It should be noted that the sensing membrane surrounding the working electrode does not necessarily have the same structure as the sensing membrane surrounding the reference electrode, etc. For example, the enzyme domain deposited on the working electrode does not necessarily need to be deposited on the reference electrode and / or the counter electrode. According to examples, sensor cores (including electrodes) and / or membrane systems can be formed in various ways, and examples of methods for forming the sensors, membrane systems, and sensor systems discussed herein can be found in currently pending U.S. Patent Application No. 16 / 452,364 (Boock et al.), the entire contents of which are incorporated herein by reference.

[0155] In the illustrated example, the sensor is an enzyme-based electrochemical sensor, where the working electrode 338 measures products (including, but not limited to, hydrogen peroxide) generated by the enzymatic catalytic reaction of glucose. In some cases, non-enzyme-based sensors, such as oxygen sensors, may be used. The detected products generate a measurable electron flow (e.g., using glucose oxidase to detect the production of hydrogen peroxide as a byproduct of glucose, where H2O2 reacts with the surface of the working electrode to produce two protons (2H+), two electrons (2e-), and one oxygen molecule (O2), which generates the detected electron flow), as described in more detail above and as understood by those skilled in the art. Preferably, one or more voltage regulators are used to monitor the electrochemical reaction at the electroactive surface of the working electrode. A potentiostat applies a constant potential to the working electrode and its associated reference electrode to determine the current generated at the working electrode. The current generated at the working electrode 338 (and flowing through the circuit to the counter electrode) is substantially proportional to the amount of H2O2 diffused to the working electrode. For example, the output signal is typically a raw data stream used to provide a recipient or physician with an available value of the measured analyte concentration in the recipient.

[0156] Some alternative analyte sensors that may benefit from the systems and methods of this disclosure include, for example, U.S. Patent No. 5,711,861 to Ward et al., U.S. Patent No. 6,642,015 to Vachon et al., U.S. Patent No. 6,654,625 to Say et al., U.S. Patent No. 6,565,509 to Say et al., U.S. Patent No. 6,514,718 to Heller, U.S. Patent No. 6,465,066 to Essenpreis et al., and U.S. Patent No. 6,214 to Offenbacher et al. U.S. Patent Nos. 5,310,469 to Cunningham et al., 5,683,562 to Shaffer et al., 6,579,690 to Bonnecaze et al., 6,484,046 to Say et al., 6,512,939 to Colvin et al., 6,424,847 to Mastrototaro et al., and 6,424,847 to Mastrototaro et al. are all cited herein by reference in their entirety. However, not all applicable analyte sensors are included; it should be understood that the disclosed examples are applicable to a variety of analyte sensor configurations.

[0157] Figure 3C It is along the CC line that passes through. Figure 3A A cross-sectional view of the sensor shows the unexposed electroactive surface of at least one working electrode 338 surrounded by a sensing membrane comprising multiple domains or multiple layers, such as an interference domain 344, an enzyme domain 346, and a resistance domain 348, and may include additional domains / membranes, such as electrode domains, cell-impermeable domains (not shown), oxygen domains (not shown), drug release membranes 370, and / or biointerface membranes 368 (not shown), as described in more detail below. Figure 3C As shown, the drug release membrane 370 is positioned adjacent to the surface of the working electrode 338 and does not cover multiple domains or layers of the working electrode 338 or the sensing membrane 332, such as the interference domain 344, enzyme domain 346, and resistance domain 348. In one example, the drug release membrane 370 is positioned at the distal end 337 of the analyte sensor 334. In another example, the drug release membrane 370 spans the electroactive portion of the working electrode 338 and does not cover the sensing membrane 332 associated with the working electrode 338.

[0158] Figures 3A to 3C A cross-section of the circular or coaxial sensor in the embodiments is depicted. Similar membranes can be applied to exemplary planar analyte sensors, such as those referenced below. Figures 4A to 8F Those discussed. An exemplary planar analyzer sensor may include a sensing membrane that is compatible with reference to... Figures 3A to 3C The membranes discussed are the same or similar components.

[0159] Planar analyzer sensor

[0160] Figures 4A to 8F A schematic diagram of a planar analyte sensor is depicted. Each of the planar analyte sensors discussed herein can be configured to measure the concentration of one or more analytes. Planar analyte sensors can be readily fabricated and produce reproducible results. Planar analyte sensors can be configured to monitor (including continuously monitor) at least one analyte, and in some examples, to monitor two or more analytes. Planar analyte sensors can be configured in different ways and can be described based on the geometry of their electrode layout. Sensor types can include single-sided or double-sided layouts. In a single-sided layout, the electrodes can be conductive traces and can be in a coplanar, stacked, or staggered arrangement. In a double-sided layout, the electrodes can be in a coplanar arrangement (aligned along a shared plane in a single layer along each substrate side), a stacked arrangement (aligned along a shared plane perpendicular to the substrate side), or a staggered arrangement (offset along one or more planes or axes), and a connector pad arrangement on one side of the sensor, or a connector pad arrangement on both sides of the sensor.

[0161] Figures 4A to 4G A single-sided coplanar analyzer sensor assembly 400 according to an example is shown. The sensor assembly may have a first end 412 and a second end 414. The sensor assembly 400 may include a substrate 410, a conductive trace 421, a connector pad 422, a working electrode 424, a counter electrode 426, an insulator 430, and a reference electrode 440. In the sensor assembly 400, a single-sided planar configuration is used. In the sensor assembly 400, a three-electrode sensor is shown, which has a working electrode (WE) 424, a counter electrode (CE) 426, and a reference electrode (RE) 440. In the sensor assembly 400, the electrodes are coplanar. In one or more embodiments, the underlying configuration of the uniplanar analyte sensor assembly 400 or other sensor assembly as discussed herein allows one or more of the reference electrode (e.g., 440) or counter electrode (e.g., 426) to be moved from the sensor assembly 400 or other sensor assembly as discussed herein to an external location (e.g., as part of a wearable 120 or other wearable device as discussed herein), rather than being deployed subcutaneously. This has the advantage of freeing up space in the host (e.g., in a wound pocket where the sensor assembly 400 is inserted) where the uniplanar analyte sensor assembly 400 or other sensor assembly is deployed for attaching a working electrode and / or for detecting additional analytes.

[0162] Furthermore, by configuring wearable 120 or other wearable devices discussed herein to include a reference electrode (440) and a counter electrode (426), such that these electrodes are deployed externally, the amount of material inserted into the body is limited. This can reduce the host's foreign body response, such as the host's immune system response. In one or more configurations, for example, the reference electrode (440) may comprise silver chloride (AgCl) or be otherwise formed from silver chloride (AgCl). However, some hosts may have a sensitivity to silver chloride. Therefore, configuring wearable 120 or other wearable devices discussed herein to include a reference electrode (440) rather than incorporating the reference electrode (440) as part of the in vivo portion of the sensor assembly discussed herein can reduce the immune response in such hosts, such as reducing eye and / or skin irritation.

[0163] Figures 4A to 4D A top-down schematic diagram of the manufactured sensor assembly 400 is shown. Figures 4E to 4G A schematic cross-sectional view of the sensor assembly 400 at different points along the length of the sensor assembly 400 is depicted.

[0164] The sensor assembly 400 may extend between a first end 412 and a second end 414, and is substantially planar along its length, as measured from the first end 412 to the second end 414. The first end 412 may be, for example, a connection end, such as for allowing the sensor assembly 400 to be electrically connected to a reader, a computer, or other components for interpreting signals detected by the sensor assembly 400. The first end 412 may accommodate one or more connection pads 422.

[0165] The second end 414 may be, for example, a sensing end for connection to or implantation in a patient, such as for detecting glucose or other analytes. The second end 414 may accommodate electrodes 424, 426, and 440. The second end 414 may be an implantable portion of the sensor assembly 400. The first end 412 of the sensor, having a connector pad 422, may be the proximal end of the sensor assembly 400. The second end 414 of the sensor, having an implantable portion containing sensing electrodes, may be the distal end of the sensor assembly 400.

[0166] like Figure 4AAs shown, substrate 410 may extend between a first end 412 and a second end 414. Substrate 410 may be a relatively planar material; for example, substrate 410 may be a thin, flexible layer for accommodating other components. In some cases, substrate 410 may be a polymer film, such as liquid crystal polymer (LCP), polyimide (PI), polyethylene terephthalate (PET), combinations thereof, or similar polymer films. Substrate 410 may have a thickness of about 25 μm to about 450 μm, such as about 75 μm to 100 μm. In some examples, substrates with a thickness of about 40 μm to about 80 μm may be used.

[0167] Conductive trace 421, connector pad 422, working electrode 424, and counter electrode 426 may be made of a conductive layer 420 constructed on a substrate. Connector pad 422 may be located on or at a first end 412 of the assembly 400 and allow electrical connection of the sensor assembly 400. Working electrode 424 and counter electrode 426 may be sensing electrodes exposed at a second end 414 of the assembly 400 for implantation and sensing of analytes in a patient environment. Conductive trace 421 can connect electrodes 424, 426 to connector pad 422.

[0168] like Figure 4B As shown, conductive layer 420 can be constructed on substrate 410, wherein conductive trace 421, connector pad 422, working electrode 424, and counter electrode 426 are in a single plane or layer. For example, conductive layer 420 can be made of sputtered metal, such as titanium / gold / platinum or platinum / gold / platinum sputtered metal layers. In this case, the associated sensing surface, such as at working electrode 424, can have exposed platinum for electrical connection and sensing. Reference electrode 440 can be deposited on the base metal pad and can be connected via additional conductive traces.

[0169] In some examples, the conductive layer 420 is formed of a single conductor, such as gold or platinum. In other examples, the conductive layer 420 may be formed of more than one material, such as a thin palladium layer covered with gold and platinum. The composition, geometry, and exposed conductor surfaces can depend on the manufacturing method, desired mechanical properties, and sensing chemistry requirements. For example, the base conductive material may be formed of a less expensive material, such as silver, which is covered with platinum in key locations for use as an active sensing surface. In some cases, gold may be plated as the base conductor, which may be covered with platinum to provide both mechanical robustness and an active sensing surface for sensing hydrogen peroxide.

[0170] The conductive layer 420, including the working electrode 424, the counter electrode 426, the connector pad 422, and the conductive trace 421, can be formed by a variety of techniques, such as electroplating, sputtering, or printing. To form a patterned structure of the conductive layer, standard photolithography, laser ablation, or printing (e.g., inkjet printing or screen printing) can be used.

[0171] Although some electrode names are shown in the supporting documentation, it should be understood that size, shape, and electrode identification can vary depending on the specific use case, such as the specific analyte to be identified. The general size and shape of the sensor is 3mm to 4mm wide at the proximal end (connector end) and 300μm to 500μm wide in the narrow, implantable distal end. The overall length of the sensor depends on the requirements of the wearable / insertion but is typically between 15mm and 25mm.

[0172] like Figure 4C As shown, insulator 430 can be stacked on top of conductive layer 420 as needed. The insulating material may be referred to as a "solder mask," "dielectric," or "insulator." These materials can be used to prevent conductive traces from being exposed to the sample matrix and environment, and to improve the accuracy and reliability of measurements by defining the area of ​​the sensing electrode. Opening 431 can be fabricated for later deposition of reference electrode 440.

[0173] Here, the insulator 430 may be made of an electrically insulating material deposited on top of the conductive layer to protect the conductive trace 421 and define openings for the connector pad 422 and electrodes 424, 426, as well as an opening 431 for the reference electrode 440. The insulator 430 may be, for example, a solder mask thin layer.

[0174] like Figure 4D As shown, reference electrode 440 material can be deposited on a designated reference electrode opening in insulator 430. The reference electrode 440 material can be, for example, a silver / silver chloride formulation. It can be deposited on a designated sensing electrode pad. This reference electrode material can be deposited using printing techniques (such as screen printing) or by discrete dispensing (such as a jet valve dispenser).

[0175] Figures 4E to 4G Cross-sections of component 400 at different points along the body of the component are depicted. Figure 4E It is shown along the central part of component 400 Figure 4D The cross-section of line EE. At this part of component 400, conductive trace 421 can be seen between insulator 430 and substrate 410. Figure 4F It is shown that along the second end 414 of component 400 Figure 4D The cross-section of the line FF. At this part of component 400, the reference electrode 440 can be seen on top of the conductive trace 421. Figure 4GA cross-section of the component along line GG near the second end 414 is depicted. The working electrode 424 can be seen here. The component 400 is arranged in a single-sided coplanar configuration for electrodes 424, 426, and 440.

[0176] Figures 5A to 5K A single-sided stacked analyte sensor assembly 500 according to an example is shown. While sensor assembly 500 is similar to assembly 400, the stacking configuration in assembly 500 includes multiple insulating layers and electrode layers on top of a substrate. Sensor assembly 500 may include components similar to those of assembly 400 discussed above, unless otherwise stated.

[0177] Figures 5A to 5G A schematic top-down diagram depicting the various layers of component 500. Figures 5H to 5K A schematic cross-sectional view of the complete sensor assembly 500 is depicted.

[0178] Sensor assembly 500 may have a first end 512 and a second end 514. Sensor assembly 500 may include a substrate 510, conductive layers 516, 517, 518, conductive traces 520, 521, 522, connector pads 523, 524, 525, a working electrode 526, a counter electrode 527, insulating layers 530, 532, 534, and a reference electrode 540. A single-sided stacked configuration is used in sensor assembly 500. A three-electrode sensor is shown in sensor assembly 500, having a working electrode (WE) 526, a counter electrode (CE) 527, and a reference electrode (RE) 540. In sensor assembly 500, the electrodes are stacked or staggered and geometrically offset from each other along the z-axis.

[0179] In sensor assembly 500, instead of the coplanar arrangement discussed above, multiple conductive layers 516, 517, 518 and insulating layers 530, 532, 534 are stacked. The conductive layers 516, 517, 518 may be staggered to provide designated exposure for electrodes 526, 527, 540 and connector pads 523, 524, 525.

[0180] like Figure 5B As shown, a first conductive layer 516 can be deposited on a substrate 510 to form a first conductive trace 520, a first sensing electrode 526, and a first connector pad 524. Figure 5CAs shown, a first insulating layer 530 may be deposited on top of the first conductive trace 520, thereby exposing the first sensing electrode 526 and the first connector pad 524. In an example, the first conductive layer 516 on the polymer substrate 510 may be printed with conductive ink. In some examples, the first conductive layer 516, or other conductive layers as discussed herein, carbon conductive inks, may be suitable for biosensor applications. In other examples, other inks containing noble metals may be used to form one or more conductive layers discussed herein, including... Figures 5A to 5K The layers discussed in the text.

[0181] exist Figure 5D In this configuration, a second conductive layer 517 may be deposited on the first insulating layer 530 for use with the second conductive trace 521, the second sensing electrode 527, and the second connector pad 525. The second conductive layer 517 may be printed with the same or different conductive ink used for the first conductive layer 516 (e.g., platinum ink suitable for biosensor applications). A second insulating layer 532 may be deposited over the second conductive layer 517, leaving openings 591, 593 for the second sensing electrode 527 and the second connector pad 525.

[0182] In some cases, this process can be repeated to form additional sensing electrodes and corresponding conductive and insulating material layers. In component 500, in... Figure 5F and Figure 5G A third conductive layer 518 and a third insulating layer 534 are added. In this example, the third conductive layer 518 can be made of silver / silver chloride ink and deposited on top of the second insulating layer 532 to form the reference electrode 540. However, additional layers can be added as needed.

[0183] Figure 5H , Figure 5I and Figure 5J Cross-sectional views of component 500 at different points along its length are depicted. Figure 5H In the image, a cross-sectional view can be seen closer to the first end 512 and the second end 514, between the conductive traces 520, 521, 522 and the scattered insulating layers 530, 532, 534. Further along the length of component 500, in... Figure 5I A cross-sectional view of component 500 with electrodes 526 and 527 can be seen in the image. Figure 5J The cross-sectional view in the middle is further directed toward the second end 514.

[0184] Figure 5K A side view of the second end 514 of component 500 is depicted. Figure 5K The view above shows the sensing end of component 500 and helps to illustrate the stepped cross-section of this stacked arrangement. Similar to the view above, Figure 5KThe view depicts a substrate 510 in which electrodes 526, 527, 540 are stacked and have insulating layers 530, 531, 532 distributed therebetween, such that electrodes 526, 527, 540 are exposed at various lengths away from the second end 514.

[0185] Figures 6A to 6E A bifacial, coplanar, unconnected analyte sensor assembly 600 according to an example is shown. While sensor assembly 600 is similar to assembly 400, the bifacial type in sensor assembly 600 includes both sides on a substrate. Sensor assembly 600 may include components similar to those of assembly 400 discussed above, unless otherwise stated.

[0186] Figures 6A to 6B A schematic top-down view of opposite sides of the sensor assembly 600 is depicted. Figures 6C to 6E A schematic cross-sectional view of the complete sensor assembly 600 is depicted.

[0187] In addition to the first end 612 and the second end 614, the sensor assembly 600 may have a first side 602 and a second side 604 opposite to the first side. The sensor assembly 600 may include a substrate 610, conductive traces 620, 621, connector pads 622, 623, working electrodes 624, 625, a counter electrode 626, insulating layers 630, 632, and a reference electrode 640. A double-planar configuration is used in the sensor assembly 600. A multi-electrode sensor is shown in the sensor assembly 600, having two working electrodes (WE) 624, 625, a counter electrode (CE) 626, and a reference electrode (RE) 640. In the sensor assembly 600, the electrodes are coplanar. The sensor assembly 600 is an unconnected variant.

[0188] In the sensor assembly 600, structures can be formed on both sides 602, 604 of the substrate 610. For example, connector pads 622, 623 can be formed on opposite sides 602, 604, respectively. This allows connection to sensing electronics from both sides of the sensor assembly 600. Similarly, conductive traces 620, 621 can be formed on both sides 602, 604 of the sensor assembly 600. On each individual side 602, 604, the conductive traces 620, 621 can be coplanar with each other.

[0189] Insulating layers 630, 632 (such as solder masks or other insulating materials) may be deposited over the conductive layers including conductive traces 620, 621. Openings may be formed in the insulating layers 630, 632 to form working electrodes 624, 625 and counter electrode 626. An opening may be provided for the reference electrode 640. A reference electrode material (such as silver / silver chloride) may be deposited on a designated sensing surface of the reference electrode 640. The insulating material may include epoxy resin, polyimide, polyurethane, polyethylene, or other materials or combinations thereof.

[0190] like Figures 6A to 6E As shown, the bifacial sensor assembly 600 may include a first working electrode 624, a second working electrode 625, a counter electrode 626, and a reference electrode 640. In some cases, such a bifacial sensor may contain more or fewer electrodes. For example, a bifacial sensor may include a single working electrode and a reference electrode.

[0191] Figures 6C to 6E A cross-section of the sensor assembly 600 is depicted. Figure 6C The diagram shows a cross-section along line CC, with substrate 610 situated between two insulating layers 630 and 632. Substrate 610 may be, for example, about 50 micrometers thick. Conductive traces 620 and 621 are visible. On the first side 602, three conductive traces 620 extend along the length of sensor assembly 600, each connecting to connector pad 622. Conductive trace 621 on the second side 604 can connect to connector pad 623.

[0192] exist Figure 6D In the middle, the cross-section is taken along line DD. The reference electrode 640 can be seen at this point. Figure 6E In the middle, the cross section is taken along line EE, and two working electrodes 624 and 625 can be seen on the opposite sides 602 and 604 of the sensor assembly 600.

[0193] Figures 7A to 7E An analyte sensor assembly 700 with bifacial coplanar connection is shown according to an example. While sensor assembly 700 is similar to assembly 400, the bifacial configuration in assembly 700 includes both sides on the substrate. Sensor assembly 700 may include components similar to those of assembly 400 discussed above, unless otherwise stated.

[0194] Figures 7A to 7B A schematic top-down view of the opposite sides of component 700 is depicted. Figures 7C to 7E A schematic cross-sectional view of the complete sensor assembly 700 is depicted. In some cases, the sensor assembly 700 may include chamfered ends, rounded ends, flat ends, or other suitable shapes.

[0195] In addition to the first end 712 and the second end 714, the sensor assembly 700 may have a first side 702 and a second side 704 opposite to the first side. The sensor assembly 700 may include a substrate 710, conductive traces 720, 721, a connector pad 722, working electrodes 724, 725, a counter electrode 726, insulating layers 730, 732, and a reference electrode 740. A double-planar configuration is used in the sensor assembly 700. A multi-electrode sensor is shown in the sensor assembly 700, having two working electrodes (WE) 724, 725, a counter electrode (CE) 726, and a reference electrode (RE) 740. In the sensor assembly 700, the electrodes are coplanar. The assembly 700 is a variant with coplanar connections.

[0196] In the sensor assembly 700, a substrate 710 is located between two sides 702 and 704, each of which can accommodate a plurality of coplanar components. For example, a coplanar conductive trace 720 may be on the first side 702, and a second conductive trace 721 may be on the second side 704. Each side 702 and 704 may be covered by insulating layers 730 and 732. The insulating layers 730 and 732 may define electrodes 724, 725, and 726, as well as an area for a reference electrode 740.

[0197] Component 700 may also include a through-hole providing electrical connectivity between the two sides 702, 704 of the sensor component 700. Including the through-hole allows connection to sensing electronics via connector pad 722 on one side 702 of the sensor, and allows for routing traces to new locations, thus enabling the use of flexible geometries. The through-hole may be formed from a variety of conductive materials discussed herein, including carbon, graphitic carbon, Pt, or combinations including Pt and C, Au and C. In some examples, the conductive material forming the through-hole between the sides 702, 704 of the component or other components, as discussed herein, may or may not include conductive nanoparticles.

[0198] like Figures 7A to 7E As shown, component 700 may include four connector pads 722 on a first side 702, electrically coupled to electrodes 725, 740 on a second side 704 via through-holes and traces. In some cases, WE, RE, and CE may be located on the side of sensor assembly 700 opposite to the connector pads 722. In some cases, as shown in component 700, a first working electrode 724 and a counter electrode 726 may be located on the first side 702 of the sensor, while a second working electrode 725 and a reference electrode 740 may be located on the other side 704 of the sensor. Through-holes can be used to establish electrical contact between traces and pads on both sides 702, 704 of the sensor assembly 700, since the connector pads 722 for connecting to sensing electronics are located on only one side.

[0199] Although sensor assembly 800 is similar to assembly 700, the double-sided type in assembly 800 includes both sides on the substrate. Sensor assembly 800 may include components similar to those of assembly 500 discussed above, unless otherwise stated.

[0200] In addition to the first end 812 and the second end 814, the sensor assembly 800 may have a first side 802 and a second side 804 opposite to the first side. The sensor assembly 800 may include a substrate 810, conductive traces 820, 821, a connector pad 822, working electrodes 824, 825, a counter electrode 826, insulating layers 830, 832, and a reference electrode 840. A double-sided stacked configuration is used in the sensor assembly 800. A multi-electrode sensor is shown in the sensor assembly 800, having two working electrodes (WE) 824, 825, a counter electrode (CE) 826, and a reference electrode (RE) 840. In the sensor assembly 800, the electrodes are staggered.

[0201] The sensor assembly 800 is similar to the assembly 400 described above, but has two sides. Figures 8A to 8F A double-sided connected analyte sensor assembly 800 is shown according to an example. Figures 8A to 8C The various layers of the first side 802 are depicted, and Figures 8D to 8F The various layers of the second side 804 are depicted.

[0202] Figure 8A The substrate 810 on the first side 802 is depicted. Figure 8B The image depicts the deposition of a conductive layer on a substrate to form a connector pad 822, a conductive trace 820, a first working electrode 824, and a counter electrode 826. Figure 8C The deposition of insulating layer 830 on the first side 802 is depicted.

[0203] Figure 8D The substrate 810 on the second side 804 is depicted. Figure 8E The deposition of a conductive layer on a substrate to form a conductive trace 821 and a second working electrode 825 is depicted. Figure 8E The construction of the second insulating layer 832 and the reference electrode 840 is depicted.

[0204] Figures 9 to 1 4 illustrates various examples of methods for manufacturing planar sensor assemblies (such as sensor assemblies 500 to 800 discussed above).

[0205] Figure 9A schematic diagram of a system 900 for manufacturing a coplanar analyte sensor assembly, according to an example, is shown. System 900 may use various components, including lamination reels 910, 912, 914, and 916, a lamination tool 920, a laser scraping station 930, an electroplating bath 940, and a rotary gravure plate 950. In other examples, the electrodes discussed herein may be formed via a micro-division operation (not shown) following laser scraping at station 930. In this example, the micro-division operation may be followed by laser splitting as discussed herein.

[0206] exist Figure 9 In the example, the component can move from left to right. Production can be continuous and scalable.

[0207] First, reels 910, 912, 914, and 916 are fed into system 900. The first reel 910 may include a substrate, such as the thin polymer substrate discussed above. The second reel 912 may, for example, include a first conductive layer, a first insulating layer, and an adhesive. The third reel 914 may include a second conductive layer, a second insulating layer, and an adhesive. The fourth reel 916 may include a third conductive layer, a third insulating layer, and an adhesive.

[0208] Reels 910, 912, 914, and 916 can be aligned, for example, to alternate conductive and insulating layers. Reels 910, 912, 914, and 916 can be fed into system 900 and into laminating tool 920, whereby these layers can be laminated together to produce a planar sheet, wherein multiple layers are fed through a production line. In some examples, thin metal foil can be used to form the conductive layer formed via a lamination operation. The thickness of the thin metal foil discussed herein can vary depending on the application and the equipment used to perform the lamination operation. The thin metal foil may include nickel, titanium, gold, platinum, or alloys or combinations thereof. In other examples, the conductive layer formed via a lamination operation as discussed herein may include a conductive material deposited on a thin polymer layer. According to examples, the conductive material may include carbon nanotubes or nanoparticles, polyaniline, or poly(3,4-ethylenedioxythiophene)polystyrene sulfonate (PEDOT:PSS).

[0209] In other examples, in addition to or in place of the second conductive layer, the second insulating layer, and the adhesive, the third reel 914 includes another substrate, which may or may not have the same composition and thickness as the substrate of the first reel 910.

[0210] The planar sheet can continue along the production line to laser scraping station 930, where one or more lasers can be used to open the contact pads and electrodes in the sensor. Additionally, the planar sheet can be cut and diced (e.g., a dicing operation) to produce individual sensor assemblies.

[0211] Optionally, individualized sensor assemblies can be passed through an electroplating bath 940 to allow electrode metallization. In some cases, individualized sensor assemblies can be passed through a rotary gravure 950 to allow reference electrode deposition. In some cases, discrete dispensing methods or slot die coating can be used instead of or in addition to the methods described above.

[0212] Figures 10A to 10B A method for manufacturing a multilayer coplanar analyzer sensor assembly is shown according to an example. Figure 10A As shown, multiple individual sensor components 1000, such as those described above, are referenced. Figure 9 The method discussed involves producing the sheet 1001 together on the production line. The sheet 1001 can move along the production line, and the individual sensor assemblies 1000 can be separated, for example, by scraping or other cutting methods.

[0213] Figures 11A to 11C A method for manufacturing a coplanar analyzer sensor assembly 1100 according to an example is shown. Figure 11A As shown, on substrate 1110, electrodes 1124, 1126, and 1140 can be alternately stacked with insulating layers 1130, 1132, and 1133. These layers can be laminated together, for example.

[0214] like Figure 11B As shown, multiple sensor assemblies can be mounted on a feed planar sheet 1101 that moves along the assembly line. Here, individual sensor assembly electrodes can be opened and electrodeposited as needed (1105). Individual components can be separated, for example, by laser scraping.

[0215] like Figure 11C As shown, the completed individual component 1100 may include a first electrode 1124, a second electrode 1126, and a third electrode 1140, which are stacked on top of each other and separated by insulating layers 1130, 1132, and 1134. Component 1100 may be accommodated by a substrate 1110.

[0216] Figure 12 A method 1200 for manufacturing a coplanar analyte sensor assembly according to an example is shown. At operation 1210, a substrate 1206, a first adhesive layer 1204, and a first electrode 1202 are laminated together. Next, at 1220, the electrode may be exposed, for example, by laser scraping. At operation 1230, a second insulating layer is applied together with the top layer and laminated onto the first electrode 1202. The assembly may be further scraped at operation 1240 to expose electrode 1226.

[0217] Figure 13A method 1300 for manufacturing a coplanar analyte sensor assembly according to an example is shown. In method 1300, an electrode 1302 may be stacked and laminated with an adhesive layer 1304 and a substrate layer 1306 (operation 1350). Unlike method 1200, operation 1350 may be completed in one step with more layers. Then, at step 1360, the electrode may be exposed, such as by scraping or removal of other specific materials.

[0218] Figures 14A to 14D A method for manufacturing a scraped coplanar analyzer sensor assembly is shown according to an example. Figure 14A The planar sheet 1401 shown can be produced by any of the methods discussed above. The planar sheet 1401 can accommodate multiple sensor assemblies 1400. These can be separated into individual assemblies 1400, such as by scraping or other separation methods.

[0219] like Figures 14B to 14D As shown, the individual sensor assembly 1400 may each include a first end 1412 and a second end 1414. At the first end 1412, various connector pads 1422 may be opened, for example by scraping, to allow electrical connection. Similarly, at the second end, electrodes 1424, 1426, and 1440 may be opened, for example by scraping, to allow sensing.

[0220] Coaxial analyte sensor

[0221] Figures 15A to 20B Exemplary coaxial sensor assemblies are depicted. For each of these examples, the sensor substrate may be cylindrical and may be fabricated, at least partially, by one or more extrusion operations. Multiple coatings may be used in conjunction with these sensors in the sensing region to allow for proper functioning of the sensor itself. In some cases, selective sensing chemicals may be used to coat the sensing region. These chemicals may include, for example, enzymes, mediators, or layers, such as those preventing interference from highly charged small molecules. Such layers may also limit the flux of analytes to the sensor. As discussed in more detail below, these layers may be applied using a variety of methods, such as discrete dispensing, spraying, dip coating, or other methods. Various electrode configurations may be discussed herein.

[0222] In some cases, each coaxial sensor assembly discussed below may have a diameter of approximately 100 micrometers (μm) to approximately 300 micrometers. In some cases, a narrower diameter may be used. In some cases, a wider diameter may be used. The sensor assemblies may have different lengths depending on the desired implantation / insertion depth and the specific sensor connection. Coaxial sensor assemblies may, for example, include a two-electrode configuration or a three-electrode configuration. The sensor substrate may be segmented into individual sensors prior to the application of a coating. In examples, the coaxial sensor assembly may include a substrate comprising a cylindrical member having a central axis surrounded by a plurality of concentric circles of increasing radius, visible through a cross-section of the substrate. In some cases, the electrodes may include cylindrical shells extending along the concentric circles. In some cases, the electrodes may include conductive material extending along one of a plurality of concentric circles offset from each other by a non-zero angle. In some cases, the electrodes may be nested within each other.

[0223] Figures 15A to 15D A coaxial analyte sensor assembly 1500 according to an example is shown. The sensor assembly 1500 may include a substrate 1510, a first electrode 1520, a second electrode 1530, a third electrode 1540, and a fourth electrode 1550. In one example, the electrodes (1520, 1530, 1540, 1550) may be configured as a counter electrode 1520, a reference electrode 1530, a first working electrode 1540, and a second working electrode 1550. In another example, the electrodes (1520, 1530, 1540, 1550) may be configured as a reference electrode 1520, a counter electrode 1530, a first working electrode 1540, and a second working electrode 1550.

[0224] The sensor assembly 1500 may extend from a first end 1502 to a second end. The first end 1502 may be a sensing end, such as for implantation in a patient to sense an analyte therein. The second end may be used for electrical connection.

[0225] The substrate 1510 may be an insulating polymer, such as polyurethane or another suitable insulating matrix. The substrate 1510 may extend from a first end 1502 to a second end and accommodate multiple wires, each wire corresponding to one of the electrodes. Each of the counter electrode 1520, the reference electrode 1530, the first working electrode 1540, and the second working electrode 1550 may be embedded within the insulating polymer substrate 1510.

[0226] Electrodes 1520, 1530, 1540, and 1550 may be made of round wires of a suitable conductive material for electrochemical sensing (e.g., platinum, gold, silver, silver, or chloride-coated silver). The wires may extend laterally along the polymer substrate 1510. Electrodes 1520, 1530, 1540, and 1550 may each have sensing regions 1521, 1531, 1541, and 1551 for electrical connection and sensing when assembly 1500 is connected to a patient to sense an analyte. In assembly 1500, electrodes 1520, 1530, 1540, and 1550 may be modified or changed to function as working electrodes, counter electrodes, and reference electrodes as required for a specific application.

[0227] exist Figures 15A to 15D In the example, various wires can be patterned around a central axis A in the polymer substrate 1510. In some cases, the patterns can be aligned around concentric circles, specific axes, spiral patterns, or other patterns as needed. The wires of electrodes 1520, 1530, 1540, and 1550 can be patterned coaxially in such a way that orientation-agnostic connections are allowed when electrodes 1520, 1530, 1540, and 1550 are exposed. Figure 15B As shown, various types of electrodes can be aligned with concentric circles B, C, D, and E respectively, thus forming a pseudo-helix when observed in cross-section.

[0228] The sensor assembly 1500 can be fabricated by co-extruding a suitable conductive material with an insulating polymer of a substrate. To form the electrodes 1520, 1530, 1540, 1550 and sensing regions 1521, 1531, 1541, 1551, the insulating material (and conductive material) can be removed in selective areas to expose specific electrodes and show the sensing regions 1521, 1531, 1541, 1551. The exposed sensing regions 1521, 1531, 1541, 1551 can be... Figure 15C and Figure 15D As seen in the diagram. For example, material can be removed by laser ablation to expose the sensing areas of electrodes 1520, 1530, 1540, and 1550. In assembly 1500, a stepped structure can be used to expose the sensing areas of electrodes 1520, 1530, 1540, and 1550. In some cases, the sensing ends can take additional shapes, such as conical shapes. In some cases, the arrangement of electrodes 1520, 1530, 1540, and 1550 can be varied, resulting in different electrode positions.

[0229] Figures 16A to 16DA coaxial analyte sensor assembly 1600 having radial wires in an insulating polymer is illustrated according to an example. The sensor assembly 1600 may include a polymer substrate 1610, a first electrode 1620, a second electrode 1630, a third electrode 1640, and a fourth electrode 1650. In one example, the electrodes (1620, 1630, 1640, 1650) may be configured as a counter electrode 1620, a reference electrode 1630, a first working electrode 1640, and a second working electrode 1650. In another example, the electrodes (1620, 1630, 1640, 1650) may be configured as a reference electrode 1620, a counter electrode 1630, a first working electrode 1640, and a second working electrode 1650. The sensor assembly 1600 may extend from a first end 1602 to a second end. The first end 1602 may be a sensing end, such as for implantation in a patient to sense analytes therein. The second end may be used for electrical connection. The components of component 1600 may be similar to those in component 1500 discussed above, unless otherwise stated.

[0230] In component 1600, reference electrode 1630 may extend along central axis A. Reference electrode 1630 may serve as the central portion of component 1600. Reference electrode 1630 may include a single lead extruded as the core of the component. Working electrodes 1640, 1650 and counter electrode 1620 may still include multiple leads patterned around core reference electrode 1630. Electrodes 1620, 1630, 1640, and 1650 may each have sensing regions 1621, 1631, 1641, and 1651 for electrical connection and sensing when component 1600 is connected to a patient to sense an analyte.

[0231] Here, the core reference electrode 1630 can be co-extruded with the working electrodes 1640, 1650 and the counter electrode 1620 on an insulating polymer substrate 1610. The core reference electrode 1630 can be, for example, a silver wire coated with silver chloride. The working electrodes 1640, 1650 and the counter electrode 1620 can be made of, for example, platinum or other conductive materials. In some examples, one or more materials used to form the conductive layer discussed herein can include one or more types of conductive nanoparticles. The working electrodes 1640, 1650 and the counter electrode 1620 can be arranged in an arc shape (such as along concentric circles B, C and D) around the core reference electrode 1630. This can be, for example, in... Figure 16A and Figure 16B It can be seen in the cross-section.

[0232] Similar to component 1500, sensing regions 1621, 1631, 1641, and 1651 can be exposed by removing the insulating substrate 1610 in the selected region. For example, the material can be removed by laser ablation. Sensing regions 1621, 1631, 1641, and 1651 can be... Figure 16C and Figure 16D As seen in component 1600, sensing regions 1621, 1631, 1641, and 1651 can be formed into a stepped structure. In some cases, other patterning can be used, and / or the positions of various electrodes can be varied.

[0233] Figures 17A to 17D A coaxial analyte sensor assembly 1700 with radially conductive electrodes in an insulating polymer substrate 1710 is illustrated according to an example. The sensor assembly 1700 may include a polymer substrate 1710, a first electrode 1720, a second electrode 1730, a third electrode 1740, and a fourth electrode 1750. In one example of the coaxial analyte sensor assembly 1700, the electrodes (1720, 1730, 1740, 1750) may be configured as a reference electrode 1720, a counter electrode 1730, a first working electrode 1740, and a second working electrode 1750. In another example, the electrodes (1720, 1730, 1740, 1750) may be configured as a counter electrode 1720, a reference electrode 1730, a first working electrode 1740, and a second working electrode 1750. Electrodes 1720, 1730, 1740, and 1750 may each have sensing regions 1721, 1731, 1741, and 1751 for electrical connection and sensing when component 1700 is connected to a patient to sense an analyte. Sensor component 1700 may extend from a first end 1702 to a second end. The first end 1702 may be a sensing end, such as for implantation in a patient to sense an analyte therein. The second end may be used for electrical connection. Components of component 1500 may be similar to those discussed above, unless otherwise stated.

[0234] In component 1700, the counter electrode 1720 may be formed differently from the extrusion of the other electrodes 1730, 1740, and 1750. The core reference electrode 1720 and the working electrodes 1740 and 1750 can be fabricated by extrusion, as discussed above with reference to components 1500 and 1600. However, the counter electrode 1720 can be formed by coating the insulating polymer substrate 1710 with a conductive agent, for example, over the co-extruded electrodes 1730, 1740, 1750 and the substrate 1710. The coating can be performed by, for example, die-casting, spraying, padding, deposition, or other methods.

[0235] To form sensing regions 1731, 1741, and 1751, selective portions of the insulating polymer substrate 1710 can be removed, for example, by laser ablation. This can be done in a stepped manner or in other shapes (such as conical). The arrangement of the electrodes can also be varied.

[0236] Figure 18A coaxial analyte sensor assembly 1800, comprising wires embedded in a photoresist insulating polymer, is shown according to an example. Assembly 1800 may include a photoresist insulating polymer substrate 1810 having a photoresist portion 1812 and wire electrodes 1820. Figure 18 The diagram illustrates a method for manufacturing a separate sensor assembly 1801 through operations including extrusion 1830, UV exposure 1840, resist development 1850, and slicing 1860. During production, UV light 1870 and a slicing tool 1880 can be used. In this concept, a wire electrode 1820 suitable for electrochemical sensing can be co-extruded with a positive photoresist to form an insulating layer.

[0237] from Figure 18 Starting from the left side, at operation 1830, a photoresist insulating polymer substrate 1810 can be co-extruded with a wire electrode 1820. The photoresist insulating polymer substrate 1810 may include one or more photoresist portions 1812. After extrusion, UV light 1870 can be used to expose the photoresist portions 1812 and remove predetermined portions of the material surrounding the wire electrode 1820. In this case, the extruded photoresist material with the wire electrode 1820 can be exposed to UV light at specific locations to define a sensing electrode region 1822 and a contact region 1824.

[0238] The exposed electrode area 1822 can then be developed and cured, for example, by hard baking, to cure the resist (operation 1850). The individual components 1821 can then be sliced ​​using a mechanical slicing tool 1880 to produce individual sensors.

[0239] Figures 19A to 19B A coaxial analyte sensor assembly 1900, including a polymer core, is illustrated according to an example. The sensor assembly 1900 may include a polymer core 1910, conductive layers 1920 and 1930, an insulating dielectric layer 1940, and a conductive layer 1950. Conductive layers 1920 and 1930 may each have sensing regions 1921 and 1931 for electrical connection and sensing as electrodes, respectively. The sensor assembly 1900 may extend from a first end 1902 to a second end 1904. The first end 1902 may be a sensing end, such as for implantation in a patient to sense analytes therein. The second end 1904 may be used for electrical connection.

[0240] In component 1900, the polymer core 1910 may be, for example, a flexible polymer core, such as an LCP polymer, extending along the central axis of component 1900. Here, the flexible polymer core 1910 may be coated within a plurality of conductive layers 1920, 1930 separated by an insulating dielectric layer 1940. Component 1900 may be externally coated with a conductive layer 1950 (such as a silver / silver chloride coating) to form a reference electrode. The polymer core 1910 allows for flexibility and overall conformability of the analyte sensor component 1900.

[0241] For example, the flexible polymer core 1910 may be coated with a conductive ink suitable for electrochemical sensing, such as screen-printed platinum ink. The conductor-coated polymer core 1901 may then be coated with an insulating dielectric layer 1940, such as polyurethane. A second conductive layer 1930 may be coated on top of the insulating dielectric layer 1940, followed by another insulating dielectric layer 1940. This process can be repeated to construct alternating layers of conductors and insulating dielectrics, ending with a final conductive layer 1950.

[0242] Conductive layers 1920 and 1930 can form electrodes and can be used to form desired electrode contacts through selective ablation of the material (e.g., by laser). Conductive layers 1920 and 1930 can be metals or other conductive materials suitable for electrochemical sensing, such as graphite carbon. Conductive layers 1920 and 1930 can have the same or different compositions for each layer, such as all Pt, Pt and C, Au and C, or combinations thereof. Conductive layer 1950 can be formed of Ag / AgCl. In an example, the component 1900 stack can have a core 1910 with a diameter of approximately 50 μm, a conductive layer with a thickness of approximately 5 μm, an insulating layer with a thickness of approximately 25 μm, and a reference electrode with a thickness of approximately 25 μm, thereby forming a sensor with a diameter of approximately 280 μm. In some examples, the core 1910 is formed of one or more polymers.

[0243] Figures 20A to 20B A coaxial analyte sensor assembly 2000, including a conductor core, is shown according to an example. The assembly 2000 may include a core 2010, which may be formed of a polymer or other material, a first conductive layer 2020, a second conductive layer 2030, an insulating layer 2040, and a reference electrode layer 2050. The assembly may extend between a first end 2002 and a second end 2004.

[0244] In component 2000, core 2010 may extend along the length of the component, and conductor core 2010 may be coated in insulating dielectric layer 2011, such as polyurethane or other insulating material. Core 2010 may be made of electrochemical sensing material. A first conductive layer 2020 may be coated on top of insulating dielectric layer 2011, followed by another insulating dielectric layer 2011. Such coatings may be alternated as needed to construct alternating layers of insulating and conductive materials. The final electrode may be the outermost conductive layer 2050.

[0245] Similar to component 1900 described above, the sensing electrode and electrode contacts can be formed by selective ablation, such as... Figure 20B As shown. The lead wire core 2010 and conductive layers 2020, 2030 can be metals or other conductive materials suitable for electrochemical sensing, such as graphite carbon. The lead wire core and conductive layers can have the same or different compositions for each layer, such as all Pt, Pt and C, Au and C, or combinations thereof. The reference electrode can be formed of Ag / AgCl. In the example, the diameter of the core 2010 can be about 50 μm, the insulating layer 2040 can be about 25 μm thick, and the conductive layer can be about 5 μm thick. In the exemplary analyte sensor assemblies 1900 and 2000, flexible combinations of materials can be used when coating the core components.

[0246] Figures 21A to 21B A double-sided stacked planar analyzer sensor according to an example is shown. Component 2100 may include a substrate 2110, a first electrode 2120, an insulating layer 2130, a second electrode 2140, and a third electrode 2150. Similar to component 500 discussed above, component 2100 may be stacked such that the sensing end of component 2100 has a stepped cross-section.

[0247] In sensor assembly 2100, a three-electrode sensor is shown, having a working electrode (WE) 2120, a counter electrode (CE) 2131, and a reference electrode (RE) 2140. In sensor assembly 2100, the electrodes are stacked or staggered and geometrically offset from each other along the z-axis. In sensor assembly 2100, instead of the coplanar arrangement discussed above, multiple conductive and insulating layers are stacked. The conductive layers may be staggered for designated exposure of electrodes 2120, 2131, and 2140. In assembly 2100, the working electrode 2120 may be stacked on both sides of assembly 2100, such as to allow for two working electrodes.

[0248] Coplanar biplane analyte sensor

[0249] This article references Figures 22A to 28CSeveral examples of biplane planar sensors with multiple electrodes positioned coplanarly relative to each other are discussed. These examples are often also connected via a planar substrate through one or more interconnects. The distal portion of a sensor with various electrodes is shown here.

[0250] For example, a continuous analyte sensor may include a substrate having a first side and an opposing second side. One or more electrodes may be located on either side of the substrate. The electrodes may include, for example, working electrodes, reference electrodes, or counter electrodes of various quantities and configurations. In the case where two or more electrodes are located on a single side of the substrate, these electrodes are substantially coplanar with each other. Each electrode typically has one or more electrical traces extending from the electrode. The electrical traces may extend to electrical connection pads or points. In some cases, these traces may travel along various interconnects from the first side of the substrate to the second side of the substrate.

[0251] For example, Figures 22A to 22B A biplanar analyte sensor 2200 is shown. The biplanar analyte sensor 2200 may have a first side 2200A and a second side 2200B opposite to the first side 2200A. The biplanar analyte sensor 2200 may include a substrate 2205 having a proximal portion 2202 and a distal portion 2204. Located on the first side 2200A on the substrate 2205 may be a first reference electrode 2210 having an associated reference electrode trace 2212 and a first working electrode 2220 having an associated working electrode trace 2222. Located on the second side 2200B on the substrate 2205 are a counter electrode 2230 with associated counter electrode trace 2232, a second working electrode 2240 with associated working electrode trace 2242 and interconnect 2244, a second reference electrode 2250 with associated reference electrode trace 2252, and a third working electrode 2260 with associated working electrode trace 2262 and interconnect 2264.

[0252] Figure 22A A first side 2200A of a biplanar analyte sensor 2200 is depicted. Here, a first working electrode 2220 and a first reference electrode 2210 are positioned coplanarly relative to each other on a substrate 2205. The first working electrode 2220 is distal to the first reference electrode 2210. In some examples, the placement of the first reference electrode 2210 and the first working electrode 2220 can be switched so that the first reference electrode 2210 is further away.

[0253] Figure 22BThe second side 2200B of the biplanar analyte sensor 2200 is depicted. Here, the counter electrode 2230, the second working electrode 2240, the second reference electrode 2250, and the third working electrode 2260 are located coplanarly on the substrate 2205. The third working electrode 2260 may be located on the distal side of the other electrodes.

[0254] As discussed above, in the presence of one or more analytes, the electrochemical reaction can cause a current to flow between the working electrode and any counter electrode, where the original sensor signal can be based on the current. If present, a reference electrode can provide a stable reference potential and conduct a very small current. Any signal from the electrodes can be transmitted via traces and interconnects in the bifacial coplanar analyte sensor 2300.

[0255] The electrodes can be coplanar with each other, as opposed to stacking. By positioning the electrodes on the same plane, the overall thickness of the sensor is reduced compared to a stacked electrode design. A thinner sensor improves user comfort during deployment and wear. Another advantage is that the coplanar electrode architecture facilitates easier film deposition. The electrodes can be aligned longitudinally along the substrate 2205. Various electrical traces 2212, 2222, 2232, 2242, 2252, and 2262, associated with each point in the corresponding electrode, provide electrical connections to the electrode. For example, working electrode traces 2262 and 2242 can extend along the length of the substrate 2205 toward the proximal portion 2202 from their associated working electrodes (2260 and 2240, respectively) located on the more distant side, allowing them to electrically couple working electrodes 2260 and 2240 to connector pads or points. To avoid these traces intersecting with other electrodes on that side of the substrate, the traces can extend from the second side 2200B across the substrate to the first side 2200A as needed.

[0256] For example, starting at the third working electrode 2260, an associated working electrode trace 2262 may extend proximally from the third working electrode 2260 to the interconnect 2264. At the interconnect 2264, the associated working electrode trace 2262 may extend proximally from the second side 2200B through the substrate to the first side 2200A. This allows the associated working electrode trace 2262 to continue proximally along the length of the substrate toward the connector or connection pad without extending through other electrodes on the second side 2200B, such as the second reference electrode 2250, the second working electrode 2240, or the counter electrode 2230.

[0257] Similarly, starting at the second working electrode 2240, an associated working electrode trace 2242 may extend from the second working electrode 2240 to the interconnect 2244, passing through the first side 2200A of the substrate 2205. This allows the trace to extend proximally from the second working electrode 2240 without interfering with the counter electrode 2230.

[0258] Using such interconnects to route traces through and along both sides of the planar substrate 2205 saves space on the biplane coplanar analyte sensor 2200 itself and allows for thinner edges around the electrodes on it.

[0259] Figures 23A to 23D A biplane analyte sensor 2300 according to an example is shown. The biplane analyte sensor 2300 may have a first side 2300A and a second side 2300B opposite to each other. The biplane analyte sensor 2300 may include a substrate 2305 having a proximal portion 2302 and a distal portion 2304.

[0260] Figure 23A A top-down view of the first side 2300A is depicted. Figure 23B A top-down view of the second side 2300B is depicted. Figure 23C A side view of a biplane coplanar analyzer sensor 2300 is depicted, showing that the electrodes thereon are coplanar with each other. Figure 23D A view of a biplane coplanar analyzer sensor 2300 without a substrate 2305 is depicted to show various electrodes, traces, and interconnects.

[0261] Located on the first side 2300A of the substrate 2305 are a first reference electrode 2310, a second reference electrode 2320 having associated reference electrode traces 2322 and interconnects 2324, and a counter electrode 2330 having associated counter electrode traces 2332. The first reference electrode 2310, the second reference electrode 2320, and the counter electrode 2330 may be positioned coplanarly with respect to each other.

[0262] The first reference electrode 2310 and the second reference electrode 2320 may have similar or different dimensions. The counter electrode 2330 may be regular or irregular in shape. In the example, the counter electrode 2330 may be located distal to the reference electrodes 2320 and 2310.

[0263] Located on the second side 2300B of the substrate 2305, there may be a first working electrode 2340 with associated working electrode traces 2342, a second working electrode 2350 with associated working electrode traces 2352 and interconnects 2354, 2356, and a third working electrode 2360 with associated working electrode traces 2362 and interconnects 2364, 2366. Here, all three working electrodes 2340, 2350, and 2360 may be on the same side of the substrate 2305 and all coplanar with respect to each other. The working electrodes 2340, 2350, and 2360 may have approximately the same size and be equidistant from each other.

[0264] The trace 2352 associated with the second working electrode 2350 may extend proximally along the second side 2300B of the substrate 2305 to the first interconnect 2354, where an electrical connection can pass through the substrate 2305 to the first side 2300A, wherein the associated working electrode trace 2352 may continue to extend proximally along the substrate 2305. At the second interconnect 2356, the electrical connection may return through the substrate 2305 to the second side 2300B, wherein the associated working electrode trace 2352 may continue to extend proximally to allow the second working electrode 2350 to be electrically connected to the connection pad. This helps to prevent the associated working electrode trace 2352 from intersecting with other traces and electrodes on the substrate 2305.

[0265] Similarly, the working electrode trace 2362 associated with the third working electrode 2360 may extend through the first interconnect 2364 to the first side 2300A, and then return through the interconnect 2366 to the second side 2300B.

[0266] Figures 24A to 24B A biplane analyte sensor 2400 according to an example is shown. The biplane analyte sensor 2400 may have a first side 2400A and a second side 2400B opposite to each other. The biplane analyte sensor 2400 may include a substrate 2405 having a proximal portion 2402 and a distal portion 2404.

[0267] Figure 24A A top-down view of the substrate 2405 on the first side 2400A is depicted. Figure 24B A top-down view of the substrate 2405 on the second side 2400B is depicted.

[0268] On the substrate 2405, located on the first side 2400A, there may be a first reference electrode 2410 with associated reference electrode trace 2412, a second reference electrode 2420 with associated reference electrode trace 2422 and interconnect 2424, and a counter electrode 2430 with associated counter electrode trace 2432. The counter electrode 2410, the first reference electrode 2420, and the second reference electrode 2430 may be coplanar with each other. The first reference electrode 2420 and the second reference electrode 2430 may have the same or different dimensions. The counter electrode 2430 may be irregularly shaped and may be the furthest from the reference electrodes 2410 and 2420.

[0269] Located on the second side 2400B on the substrate 2405, there may be a first working electrode 2440 with associated working electrode trace 2442, a second working electrode 2450 with associated working electrode trace 2452 and interconnects 2454, 2456, and a third working electrode 2460 with associated working electrode trace 2462 and interconnects 2464.

[0270] Similar to the previous example, traces associated with various electrodes can be routed between the two sides of the substrate using interconnects. This helps prevent traces from crossing other coplanar electrodes on either side of the substrate.

[0271] Figures 25A to 25E A biplane coplanar analyte sensor 2500 according to an example is shown. The biplane coplanar analyte sensor 2500 may have a first side 2500A and a second side 2500B opposite to each other. The biplane coplanar analyte sensor 2500 may include a substrate 2505 having a proximal portion 2502 and a distal portion 2504.

[0272] Figure 25A A top-down view of the first side 2500A of substrate 2505 is depicted, while Figure 25B A top-down view of the second side 2505B of substrate 2500 is depicted. Figure 25C A view of a biplane coplanar analyzer sensor 2500 without a substrate 2505 is depicted to show the various electrodes, traces, and interconnects. Figure 25D A side view of a biplane coplanar analyte sensor 2500, including a substrate 2505, is depicted.

[0273] Located on the first side 2500A of the substrate 2505 are a counter electrode 2510, a first reference electrode 2520 having associated reference electrode traces 2522 and interconnects 2524, and a second reference electrode 2530 having associated reference electrode traces 2532.

[0274] The counter electrode 2510, the first reference electrode 2520, and the second reference electrode 2530 may be coplanar. The first reference electrode 2520 and the second reference electrode 2530 may have the same or different dimensions. The counter electrode 2510 may be relatively rectangular, or may have tapered edges or an alternative shape as needed. Figure 25E The design of a biplane coplanar analyzer sensor 2500 with counter electrodes 2510 having different shapes is described.

[0275] Located on the second side 2500B on the substrate 2505, there may be a first working electrode 2540 with associated working electrode traces 2542, a second working electrode 2550 with associated working electrode traces 2552 and interconnects 2554, 2556, and a third working electrode 2560 with associated working electrode traces 2562 and interconnects 2564.

[0276] Similar to the previous example, traces associated with various electrodes can be routed between the two sides of the substrate using interconnects. This helps prevent traces from crossing other coplanar electrodes on either side of the substrate.

[0277] Figures 26A to 26C A biplane coplanar analyte sensor according to an example is shown. The biplane coplanar analyte sensor 2600 may have a first side 2600A and a second side 2600B opposite to each other. The biplane coplanar analyte sensor 2600 may include a substrate 2605 having a proximal portion 2602 and a distal portion 2604.

[0278] Figure 26A A top-down view of the biplane coplanar analyzer sensor 2600 on the first side 2600A is depicted, while Figure 26B A top-down view of the biplane coplanar analyzer sensor 2600 on the second side 2600B is depicted. Figure 26C A side view of the biplane coplanar analyzer sensor 2600 is depicted.

[0279] Located on the first side 2600A of the substrate 2605, there may be a counter electrode 2610 with associated counter electrode trace 2612, a first reference electrode 2620 with associated reference electrode trace 2622 and interconnect 2624, and a second reference electrode 2630 with associated reference electrode trace 2632 and interconnect 2634.

[0280] The counter electrode 2610, the first reference electrode 2620, and the second reference electrode 2630 may be coplanar. The first reference electrode 2620 and the second reference electrode 2630 may have the same or different dimensions.

[0281] Located on the second side 2500B of the substrate 2605, there may be a first working electrode 2640 with associated working electrode traces 2642 and interconnects 2644, a second working electrode 2650 with associated working electrode traces 2652 and interconnects 2654 and 2656, and a third working electrode 2660 with associated working electrode traces 2662 and interconnects 2664. In the bifacial coplanar analyte sensor 2600, the working electrodes 2640, 2650, and 2660 may have equal but decreasing spacing.

[0282] Similar to the previous example, traces associated with various electrodes can be routed between the two sides of the substrate using interconnects. This helps prevent traces from crossing other coplanar electrodes on either side of the substrate.

[0283] Figures 27A to 27D A biplane coplanar analyte sensor 2700 according to an example is shown. The biplane coplanar analyte sensor 2700 may have a first side 2700A and a second side 2700B opposite to each other. The biplane coplanar analyte sensor 2700 may include a substrate 2705 having a proximal portion 2702 and a distal portion 2704.

[0284] Figure 27A A top-down view depicting a biplane coplanar analyzer sensor 2700 on the first side 2700A of substrate 2705 is shown. Figure 27C A top-down view depicting a biplane coplanar analyzer sensor 2700 on the second side 2700B of substrate 2705 is shown. Figure 27B A side view of the biplane coplanar analyzer sensor 2700 is depicted. Figure 27D A view of a biplane coplanar analyte sensor 2700 with a substrate 2705 is shown to show the various electrodes, traces, and interconnects.

[0285] On the substrate 2705, located on the first side 2700A, there may be a first reference electrode 2710 with associated reference electrode trace 2712 and a second reference electrode 2720 with associated reference electrode trace 2722. The first reference electrode 2710 and the second reference electrode 2720 may be coplanar with each other. The first reference electrode 2710 and the second reference electrode 2720 may have similar or different dimensions.

[0286] Located on the second side 2700B on the substrate 2705, there may be a counter electrode 2730 with associated counter electrode trace 2732, a first working electrode 2740 with associated working electrode trace 2742, a second working electrode 2750 with associated working electrode trace 2752 and interconnect 2754, and a third working electrode 2760 with associated working electrode trace 2762 and interconnect 2764.

[0287] Similar to the previous example, traces associated with various electrodes can be routed between the two sides of the substrate using interconnects. This helps prevent traces from crossing other coplanar electrodes on either side of the substrate.

[0288] In the bifacial analyte sensor 2700, having a counter electrode 2730 and working electrodes 2740, 2750, 2760 on the second side 2700B of the substrate 2705 allows for more space to increase the area of ​​one or more of the reference electrodes 2710, 2720.

[0289] Figures 28A to 28C A biplane coplanar analyte sensor 2800 according to an example is shown. The biplane coplanar analyte sensor 2800 may have a first side 2800A and a second side 2800B opposite to each other. The biplane coplanar analyte sensor 2800 may include a substrate 2805 having a proximal portion 2802 and a distal portion 2804.

[0290] Figure 28AA top-down view depicts a biplane coplanar analyzer sensor 2800 on the first side 2800A of substrate 2805. Figure 28C A top-down view depicting a biplane coplanar analyzer sensor 2800 on the second side 2800B of substrate 2805 is shown. Figure 28B A side view of the biplane coplanar analyzer sensor 2700 is depicted.

[0291] On the substrate 2805, located on the first side 2800A, there may be a first reference electrode 2810 with associated reference electrode trace 2812, a second reference electrode 2820 with associated reference electrode trace 2822 and interconnect 2824, and a counter electrode 2830 with associated counter electrode trace 2832. Here, the counter electrode 2830 may be located on the distal side of both the first reference electrode 2810 and the second reference electrode 2820.

[0292] Located on the second side 2800B on the substrate 2805, there may be a first working electrode 2840 with associated working electrode trace 2842, a second working electrode 2850 with associated working electrode trace 2852 and interconnects 2854, 2856, and a third working electrode 2860 with associated working electrode trace 2862 and interconnects 2864.

[0293] Similar to the previous example, traces associated with various electrodes can be routed between the two sides of the substrate using interconnects. This helps prevent traces from crossing other coplanar electrodes on either side of the substrate.

[0294] refer to Figures 22A to 28C The various configurations of planar sensor electrode layouts depicted and discussed all include coplanar biplane configurations with interconnects extending through the substrate. These layouts allow for the efficient positioning of various working electrodes, counter electrodes, and reference electrodes, as well as their associated traces, while maintaining a small overall space.

[0295] Sensor end configuration

[0296] The distal portion of an analyte sensor (such as the planar analyte sensor described herein) is typically used during the insertion of such a percutaneous sensor. In many cases, an inflammatory response can occur after such insertion. Reference Figures 29 to 34 Examples of sensor tip designs for reducing post-insertion inflammatory responses are shown and discussed. For instance, many of these designs allow for a reduction in the amount of tissue damage during insertion.

[0297] Figure 29A sensor 2900 with a distal portion 2906 is shown according to an example. The sensor 2900 may have a substrate 2905 extending between a distal portion 2902 and a proximal portion 2904. The sensor 2900 may include a distal portion 2906 having a perforation 2908. The perforation 2908 may allow the distal portion 2906 to be more flexible or resilient during insertion, such as to reduce tissue damage and inflammatory response.

[0298] Figure 30 A sensor 3000 with an end portion 3006 is shown according to an example. The sensor 3000 may have a substrate 3005 extending between a distal portion 3002 and a proximal portion 3004. The sensor 3000 may include the end portion 3006 made of a soft material. The end portion 3006 may be made of a material softer than the material used to manufacture the rest of the sensor 3000. For example, the end portion 3006 may be made of a hydrogel or an elastomer (such as silicone). In the example, the end portion 3006 may be made of a material whose hardness measurement is less than the hardness measurement of the substrate 3005 material.

[0299] Figure 31 A sensor 3100 with an end portion 3106 is shown according to an example. The sensor 3100 may have a substrate 3105 extending between a distal portion 3102 and a proximal portion 3104. The sensor 3100 may include an end portion 3106 having a cap fixed to the distal portion 3102 of the substrate 3105. The end portion 3106 may be, for example, rounded and at least partially cover the distal end of the substrate 3105. For example, the cap may be made of a hydrogel or an elastomer (such as silicone). In the example, the end portion 3106 may be a cap formed by immersing the distal portion 3102 in such a material.

[0300] Figure 32 A sensor 3200 with a distal portion 3206 is shown according to an example. The sensor 3200 may have a substrate 3205 extending between a distal portion 3202 and a proximal portion 3204. The sensor 3200 may include a flexible distal portion 3206, such as to provide damping against puncture forces during insertion. The distal portion 3206 may be flexible by means of the material it is made of or by means of its shape, such as by means of a tapered or recessed portion of the distal portion 3206 that allows for greater flexibility relative to the remainder of the substrate 3205.

[0301] Figure 33A sensor 3300 with an end portion 3306 is shown according to an example. The sensor 3300 may have a substrate 3305 extending between a distal portion 3302 and a proximal portion 3304. The sensor 3300 may include the end portion 3306, which is shown in an enlarged view. In this example, the end portion 3306 may be an integral part of the substrate 3305. The end portion 3306 may be perforated 3308, such as in a circular, elliptical, or square pattern. The perforations may be arranged at a regular density along the end portion 3306 to give it greater flexibility.

[0302] Figure 34 A sensor 3400 with an end portion 3406 is shown according to an example. The sensor 3400 may have a substrate 3405 extending between a distal portion 3402 and a proximal portion 3404. The sensor 3400 may include the end portion 3406. In this example, the end portion 3406 may be an integral part of the substrate 3405. The end portion 3406 may include a rounded portion 3407 and two notches 3408. The two notches 3408 allow the rounded portion 3407 to move back and forth during insertion and allow flexibility.

[0303] Current-type and potential-type combined sensor

[0304] In some cases, a planar sensor may include more than one sensor type. In other words, multiple types of sensors can be integrated into the same planar substrate. For example, the planar substrate may house a first sensor system and a second sensor system, both integrated onto the planar substrate. In some cases, the first sensor system and the second sensor system may be located on the same side of the planar substrate. In some cases, the first sensor system and the second sensor system may be located on opposite sides of the planar substrate. In some cases, one or both of the first sensor system and the second sensor system may extend across the substrate and have components on both sides of the substrate.

[0305] One of the first or second sensor systems can be, for example, a continuous analyzer sensor, such as the one mentioned above. Figures 22A to 28C The aforementioned. Such sensor systems may, for example, include a working electrode, a reference electrode, and at least one analyte sensing membrane.

[0306] The first sensor system can be a sensor system configured to perform a first type of measurement. The second sensor system can be a sensor system configured to perform a second type of measurement, different from the first type of measurement.

[0307] For example, one sensor system in a sensor system could be a current-type sensor, such as those discussed above. Current-type sensors induce oxidation or reduction of an electroactive substance by using a potential applied between a reference electrode and a working electrode. Using a current-type sensor, the resulting current can be measured. Such a current-type sensor can estimate interstitial glucose levels by measuring the current generated by the reaction of glucose with oxygen or with a fixed redox mediator. An example of a current-type sensor can be found in U.S. Application Serial No. 63 / 403,568, filed September 2, 2022, entitled “CONTINUOUS MULTI-ANALYTE SENSOR DEVICES AND METHODS,” the entire contents of which are incorporated herein by reference.

[0308] In the examples, other sensors can be different types of electrochemical sensors, such as potentiometric sensors or conductivity sensors. For example, another sensor system could be a potentiometric sensor. In such a sensor system, the electrode or membrane potential can then be measured. For example, the sensor measurement can be obtained based on the potential difference between two electrodes. By comparison, using a conductivity sensor, conductivity can be measured at a range of frequencies. An example of a potentiometric sensor can be found in U.S. Application Serial No. 63 / 403,582, filed September 2, 2022, entitled “DEVICES AND METHODS FOR MEASURING ANELECTROPHYSIOLOGICAL SIGNAL AND / OR A CONCENTRATION OF A TARGET ANALYTE IN ABIOLOGICAL FLUID IN VIVO,” the entire contents of which are incorporated herein by reference.

[0309] In an exemplary potentiometric sensor system, the sensor system may include a first electrode disposed on a substrate; an ion carrier disposed on the substrate and configured to selectively transport target ions to or within the first electrode; and a second electrode disposed on the substrate. In this case, the potentiometric sensor system may also include sensor electronics. Such sensor electronics may be configured to generate a first signal corresponding to a current response at least partially based on a reaction at the working electrode corresponding to the concentration of a first analyte; and to generate a second signal corresponding to an electromotive force at least partially based on the potential difference generated between the first and second electrodes in response to the ion carrier transporting target ions corresponding to the concentration of a second analyte to the first electrode.

[0310] In some cases, the second sensor system can be a non-electrochemical sensor. For example, different types of sensors, such as accelerometers or blood oxygen level sensors, can be integrated together on a substrate. In some cases, in addition to measuring different types of substances, the first and second sensor systems can also be designed for different analytes.

[0311] In some cases, a third sensor system can be integrated into a planar substrate. In this case, the third sensor system can be a sensor of a different type from the first or second sensor system, or it can be a sensor of the same type as the first or second sensor system.

[0312] Sensor with L-shaped structure

[0313] Figures 35A to 36 An exemplary sensor architecture with an overall L-shape is depicted, wherein the substrate itself contains a bend or angle connecting the distal and proximal portions. The L-shaped architecture can be beneficial for insertion and detectability. In this way, the L-shaped architecture reduces or eliminates any bias forces caused by bending an otherwise straight sensor.

[0314] Figures 35A to 35B An L-shaped sensor 3500 is shown as an example. Figure 35A The L-shaped sensor 3500 in the first configuration 3500A is depicted, while Figure 35B The L-shaped sensor 3500 in the second configuration 3500B is depicted.

[0315] The L-shaped sensor 3500 may include a planar substrate having a distal portion 3510 and a proximal portion 3520. The distal portion 3510 and the proximal portion 3520 may be joined together by a joining portion 3515. The joining portion 3515 may connect the distal portion 3510 and the proximal portion 3520 at a generally perpendicular angle. The distal portion 3510 and the proximal portion 3520 may be of approximately the same length or have different lengths.

[0316] The distal portion 3510 may include an electrode 3512. Various amounts of functional electrodes (such as a working electrode, a reference electrode, and a counter electrode) may be present on the distal portion 3510. (See above reference.) Figures 22A to 28C An exemplary electrode layout is shown and discussed. One or more analyte sensing films may be extended over electrode 3512 as needed.

[0317] The proximal portion 3520 may include a connection area that accommodates a connection pad 3532. The connection pad 3532 may be electrically connected to the electrode 3512 via traces extending through the engagement portion 3515. The traces routed through the engagement portion 3515 can do this without requiring bending of the flexible printed circuit. The proximal portion 3520 may have a wider width than the distal portion 3510.

[0318] The proximal portion 3520 in the first configuration 3500A is shown in a folded configuration. The proximal portion 3520 in the second configuration 3500B is shown in an unfolded configuration. Folding along the dashed line of the second configuration 3500B allows the host connection pad 3532 to be parallel to the transmitter printed circuit board assembly. In some cases, the folded portion 3530 may contain one or more interconnects.

[0319] Figure 36 An L-shaped sensor 3600 according to an example is shown. The L-shaped sensor 3600 may include a distal portion 3610 and a proximal portion 3620 connected by a joining portion 3615.

[0320] The distal portion 3610 may include a first electrode 3612 and a second electrode 3614, which may be, for example, a working electrode, a reference electrode, a counter electrode, or a combination thereof. Additional electrodes may be located on opposite sides of the substrate. Electrodes 3612 and 3614 may be electrically connected via a trace 3618 extending through the junction portion 3615.

[0321] The proximal portion 3620 may include a connection pad 3625 electrically coupled to electrodes 3612, 3614 (and any electrodes on the opposite side of the substrate) via traces 3618. In some cases, the L-shaped sensor 3600 may include a reinforcement 3630 on the proximal portion 3620. The reinforcement 3630 may provide mechanical and structural support to the L-shaped sensor 3600. Additionally, one or more functional components may be supported on the proximal portion 3620, such as by the reinforcement 3630.

[0322] Sensor with cubic structure

[0323] Figures 37A to 39D An exemplary sensor architecture that is essentially cubic is depicted. Such a sensor architecture is suitable for multi-analyte sensing and electrode miniaturization. Additionally, current analysis sensors may be limited by the space required for the reference electrode. In the case of a cubic sensor, additional space exists on various cubic surfaces for such a reference electrode.

[0324] Figures 37A to 37DA geometry for multianalyte sensing is depicted, where the reference electrode and counter electrode are located on sides with a cubic shape factor. This is possible due to the small surface area available to each electrode in the planar geometry and the fact that the dimensions of the reference and counter electrodes can be small and constrained. In this concept, all or some sides of the cube can be coated with reference ink, and the two larger surfaces can be coated with electrode ink, with an enzyme layer applied on top of them. This approach maximizes the reaction surface. Here, the electrodes can be placed adjacent to each other on one plane (front), two planes (front and back), or 3-5 planes (front, back, and sides, in a cubic design). The sensor can be a PCB-based material with traces and electrodes.

[0325] Figures 37A to 37D A cubic sensor 3700 is shown as an example. Figure 37A and Figure 37B A front view of the cubic sensor 3700 is depicted. Figure 37C and Figure 37D A rear view of a cubic sensor 3700 is depicted. The cubic sensor 3700 may include a substrate 3705, a first working electrode 3710, a second working electrode 3720, a reference electrode 3730, a third working electrode 3740, and a fourth working electrode 3750.

[0326] The substrate 3705 can essentially be a cube with six sides. Each of the working electrodes 3710, 3720, 3740, and 3750 can be located on one of the main sides of the substrate 3705. In contrast, the reference electrode 3730 can be located on one of the smaller sides of the cubic substrate 3705. Figure 38 This cubic sensor 3800 is shown operably connected to circuit board 3850 according to an example.

[0327] Each of the working electrodes 3710, 3720, 3740, and 3750 may include a membrane thereon. Different types of enzyme layers may be used on each working electrode as needed, such as for detecting multiple types of analytes. In some cases, a string of cubic sensors connected to each other may be used.

[0328] Figures 39A to 39D A method for fabricating a cubic sensor according to an example is described. During fabrication, after such an enzyme layer is applied to the working electrode, the cubic sensor 3700 can then be coated with different resistive layers, for example, by deposition or impregnation. An exemplary process of impregnating two enzyme layers followed by impregnation of a resistive layer is shown here. This process can utilize the application of a masking sheet in the first step (…). Figure 39A First, the upper working electrode is coated, and then the impregnation length parameter is controlled to impregnate the second enzyme layer and the resistor layer. Figure 39B ).

[0329] In some cases, more layers of both can be added by changing the impregnation parameters midway through the process. Figure 39C In some cases, alternative methods can be used to produce the enzyme layer and resistive layer for the working electrode. For example, they can be sprayed. To facilitate the addition of the enzyme layer and resistive layer, the sensor can employ interconnected shape factors, as depicted in the figure below.

[0330] Reference inks can be applied to the sides of a substrate using various methods to create reference electrodes. For example, a large surface can be covered with a polymer masking layer while the entire sensor is sprayed or deposited with reference ink, and then the masking layer can be removed to add a film and resistive layer for the working electrodes. Reference electrodes can also be sprayed to exhaust on the sides and ends of a cube.

[0331] To apply electrical connections to wearables and transmitters, pins can be connected to each extended electrode. After all the polymer films are applied, the sensor is then cut into individual sensors using laser cutting or a similar method. Figure 39D ).

[0332] Multianalyte sensors and methods for manufacturing membranes

[0333] The sensors discussed in this article may include membranes fabricated in various ways, such as those discussed above. In some cases, the membrane may target glucose as an analyte. In others, the membrane may target more than one analyte, such as glucose, and additional analytes, such as lactate. When using multi-analyte membranes, the membrane may contain more than one type of enzyme layer to aid in the detection of various analytes. In some cases, such membranes may be extended over more than one working electrode. In still others, different membranes with different enzyme layers may be produced on different working electrodes, allowing individual working electrodes to target specific analytes.

[0334] Figure 40 A flowchart illustrating a method for fabricating a planar analyte sensor membrane, based on an example, is provided. As discussed above, various methods can be used to produce the sensor substrate and electrodes. Similarly, various methods can be used to produce membranes for current (or other electrochemical) sensing of analytes such as glucose or lactate.

[0335] For example, the membrane can be deposited onto the electrode or formed simultaneously with the electrode. In some cases, spray valve dispensing can be used to produce such a membrane. In some cases, slit-type die coating can be used to produce such a membrane. In some cases, impregnation can be used to produce such a membrane. In some cases, discrete dispensing can be used to produce such a membrane. In some cases, an enzyme layer (EZL) is deposited as a layer. In some cases, the membrane may include more than one EZL, such as containing one or more analyte-sensitive enzymes. In some cases, such a layer can detect multiple analytes, such as glucose, lactate, or other analytes. Such EZLs can typically be stacked on top of an intermediate layer (IL) deposited on the electrode region. After the IL and the first EZL, an additional EZL layer can be deposited. Finally, a resistive layer (RL) can be deposited.

[0336] Figure 40 Method 4000 depicts a slit-die film production method for such films. Here, films are produced simultaneously on a large number of sensor substrates, moving from left to right in the figure. First, at step 4010, aligned sensor substrates are received. Here, a first common IL is deposited by slit-die coating. This common IL is common to all coated electrodes.

[0337] Next, at step 4020, an EZL layer is produced on top of the common IL. Here, in Figure 40 In the illustration, a glucose-sensitive EZL is applied to the central electrode, while different EZLs (e.g., for different analytes) are deposited on the upper and lower electrodes. Subsequently, in step 4030, a resistive layer is deposited on top of the EZL layers. Similarly, the intermediate electrode is coated with a glucose-sensitive RL, while the top and bottom electrodes are coated with RLs for different analytes. In this manner, multiple planar sensors are fabricated simultaneously, with electrodes targeting multiple analytes.

[0338] Digital Sensors

[0339] In the various examples described herein, an analyte sensor (such as any of the analyte sensors described herein) is electrically coupled to sensor electronics (such as sensor electronics 106). As described herein, an electrochemical reaction at the electrodes of the analyte sensor causes the analyte sensor to generate an analog signal indicating the concentration of the analyte at the respective electrode. As described herein, the analog signal may be a current in the picoampere range. In some arrangements, the analog signal is provided from the analyte sensor to the sensor electronics via a connector (such as a connector comprising one or more copper or other metal contacts).

[0340] However, transmitting analog signals via connectors can present certain challenges. For example, the analyte sensor and sensor electronics may be located on or near the host's skin. In this environment, moisture and other contaminants may be present. Moisture, contaminants, and other environmental factors at the host site can interfere with the analog signals transmitted through the connector. Furthermore, in some analyte sensors, the analog signals generated by the analyte sensor can have relatively low amplitudes. This can make the analog signals generated by the analyte circuitry susceptible to noise, interference, and other signal degradation that may occur at the connector between the analyte sensor and sensor electronics.

[0341] These issues can increase the cost and / or complexity of analyte sensor systems. For example, it may be desirable to make connectors as robust as possible, including, for instance, sealing the connector or even the sensor assembly. For example, the connector may be positioned within a housing with sufficient structural strength to prevent deformation and may include gaskets or other suitable sealing mechanisms to prevent moisture from reaching the connector's electrical contacts. In some examples, the connector may include contacts mechanically coupled to a spring that tends to maintain electrical coupling between the contacts. However, even these mitigations cannot completely eliminate signal degradation at the connector. Noise generated by transmitting analog signals via the connector can still degrade the performance of the analyte sensor system and / or cause premature failure.

[0342] The various examples described herein address these and other challenges by utilizing an analyte sensor comprising a substrate having analog front-end circuitry mechanically and electrically coupled to the substrate. The substrate may include one or more electrodes electrically coupled to the analyte sensor and also electrically coupled to one or more traces of the analog front-end circuitry. In some examples, the mechanical coupling of the analog front-end circuitry to the substrate shields the connections between the analog front-end circuitry and the one or more traces, thereby protecting those connections from moisture, contaminants, and other environmental conditions.

[0343] Analog front-end circuitry may include various sub-circuits for conditioning analog signals received from the analyte sensor. In some examples, analog front-end circuitry may include an analog-to-digital converter (ADC) to convert analog signals into digital signals. The digital signals may be provided to the sensor electronics via connectors, such as connectors comprising one or more copper or other metal contacts. Because the connectors are after the analog front-end circuitry in the signal chain, the signals transmitted across the connectors can be digital (generated by the ADC at the analog front-end circuitry). This arrangement mitigates noise problems associated with the connectors because digital signals may be less susceptible to noise and other signal degradation than analog signals.

[0344] In some examples, such as during manufacturing, calibration checks are applied to analyte sensors. Calibration checks can be applied at least partially to detect any manufacturing defects in the analyte sensor. If a manufacturing defect in the analyte sensor is detected that renders the sensor unusable, the defective sensor can be discarded. In various examples, mechanically coupling analog front-end circuitry to the substrate of the analyte sensor can reduce the risk of the sensor being discarded during calibration checks. For example, some calibration check failures can be attributed to degradation of the analog sensor signal between the analyte sensor itself and one or more test probes. In arrangements where the analog front-end circuitry is mechanically and electrically coupled to the substrate of the analyte sensor (such as those described herein), calibration checks can be performed using one or more digital signals generated by the analog front-end circuitry. Because digital signals may be less susceptible to degradation in the presence of moisture and / or other environmental factors, this can reduce the number of calibration check failures due to signal degradation, thereby reducing the total number of analyte sensors discarded during manufacturing.

[0345] Figure 41 This diagram illustrates an example of an analyte sensor system 4100, which includes an analyte sensor 4104 electrically coupled to sensor electronics 4106 via a connector 4130. The analyte sensor 4104 may include analog front-end circuitry 4126. Therefore, the raw sensor signal transmitted to sensor electronics 4106 via connector 4130 can be a digital signal rather than an analog signal. As described herein, this can reduce signal degradation across connector 4130 due to moisture and / or other environmental conditions. In some examples, connector 4130 includes one or more sensor-side contacts electrically coupled to the analog front-end circuitry 4126 and one or more electronics-side contacts electrically coupled to sensor electronics 4106. The one or more sensor-side contacts and the one or more electronics-side contacts may be in physical contact with each other to electrically couple the analog front-end circuitry 4126 to sensor electronics 4106.

[0346] As described herein, the analyte sensor 4104 may include electrodes 4121, 4122, 4124 that generate one or more electrical signals. Electrodes 4121, 4122, 4124 may be arranged in any suitable manner. In some examples, the analyte sensor 4104 may be configured according to a three-electrode arrangement including a working electrode, a counter electrode, and a reference electrode. In other examples, the analyte sensor 4104 may be arranged according to a two-electrode configuration including a working electrode and a reference / counter electrode. Furthermore, it should be understood that in some examples, the analyte sensor 4104 may include more than one working electrode. As described herein, different working electrodes may be configured to generate electrical signals indicating different analyte concentrations.

[0347] The analyte sensor 4104 may include a sensor substrate 4120. The sensor substrate 4120 may be a planar substrate, such as those described herein. Any suitable material may be used for the planar substrate. In some examples, the planar substrate may be constructed of glass-reinforced epoxy resin that meets suitable standards, such as, for example, FR4 standard issued by the National Electrical Manufacturers Association (NEMA). In some examples, all or part of the sensor substrate 4120 may be a flexible substrate, such as, for example, a substrate 410 similar to those described herein. In some examples, electrodes 4121, 4122, 4124 may be bonded to the sensor substrate 4120, such as those described herein. The sensor substrate 4120 may also include conductive traces 4132 deposited thereon. The conductive traces 4132 may electrically couple the various electrodes 4121, 4122, 4124 to analog front-end circuitry 4126.

[0348] The analog front-end circuit 4126 may include various signal conditioning circuits, such as, for example, gate circuit 4194 similar to gate circuit 294, measurement circuit 4102 similar to measurement circuit 202, etc. For example, measurement circuit 4102 may be and / or include a voltage regulator, similar to measurement circuit 202 described herein. The analog front-end circuit 4126 may also include an analog-to-digital converter 4128. The analog-to-digital converter 4128 can receive analog signals and convert them into digital signals. The digital signals generated by the analog-to-digital converter 4128 can be provided to sensor electronics 4106 via connector 4130.

[0349] Sensor electronics 4106 may include various components, such as those similar to Figure 2 The sensor electronics 106 described herein may include components such as processor 4105 (similar to processor 204), memory 4108 (similar to memory 208), instructions 4107 (similar to instructions 206), data storage device 4110 (similar to data storage device 210), one or more sensors 4112 (similar to sensor 212), battery 4114 (similar to battery 214), and wireless communication circuit 4118 (similar to wireless communication circuit 218), etc. It should be understood that in some examples, sensor electronics 4106 may include... Figure 41 Various other components not shown and / or which may be omitted. Figure 41 Some of the components shown are illustrated. In some examples, sensor electronics 4106 can communicate with one or more peripheral devices (such as peripheral device 250) and / or one or more medical devices (such as medical device 270).

[0350] The analog front-end circuit 4126 can be arranged and packaged in any suitable manner. In some examples, the analog front-end circuit 4126 may include an analog front-end chip comprising a substrate having various components positioned thereon. For example, the substrate may be or comprise a silicon wafer, on which some or all of the components of the analog front-end circuit 4126 are fabricated. The silicon wafer can be packaged in any suitable housing. Moreover, in some examples, the analog front-end circuit 4126 may include an FR4 or similar substrate on which the various components of the analog front-end circuit 4126 are connected. In some examples, the analog front-end circuit 4126 may be or comprise a commercially available analog front-end circuit chip.

[0351] Various inputs and outputs of the analog front-end circuit 4126 may include conductive contacts arranged as pins, pads, etc. The analog front-end circuit 4126 may be mechanically and electrically coupled to the sensor substrate 4120 in any suitable manner. For example, the analog front-end circuit 4126 may be surface-mounted to the sensor substrate 4120. Surface mounting may include making electrical connections between the contacts of the analog front-end circuit 4126 and corresponding contacts formed on the sensor substrate 4120. Any suitable technique (including, for example, aluminum wedge bonding, wire bonding, underfill, and / or similar techniques) may be used to make the electrical connections. In some examples, techniques used to create electrical connections may also mechanically couple the analog front-end circuit 4126 to the sensor substrate 4120. Furthermore, in some examples, the analog front-end circuit 4126 may be mechanically coupled to the sensor substrate 4120 using mechanisms other than or replacing the mechanical coupling provided by the electrical connections. For example, an adhesive such as a non-conductive epoxy resin may be used to mechanically couple the analog front-end circuit 4126 to the sensor substrate 4120.

[0352] Figure 42 This is a diagram showing an example arrangement of the analog front-end circuit 4126. Figure 42 In the example, analog front-end circuitry 4126 includes analog front-end chip 4202 and additional components 4208. Analog front-end chip 4202 includes various inputs and outputs. For example, the inputs and outputs of analog front-end chip 4202 may be implemented as pins, surface mount pads, and / or any other suitable connector arrangement. Exemplary inputs to analog front-end chip 4202 include input voltage (VDD), regulator input (REG), and ground (GND).

[0353] exist Figure 42In the examples, the analog front-end chip 4202 includes various inputs and outputs for interfacing with sensor electronics 4106. In some examples, the inputs and outputs for interfacing with sensor electronics 4106 are digital inputs and outputs. These may include, for example, a clock input (CLK), an interrupt line (INTB1), and various data inputs / outputs (e.g., D1, D2, ..., DN). The clock input may receive a clock signal generated by sensor electronics 4106 (e.g., a clock signal generated by and / or used by processor 4105). The interrupt line may be used by the analog front-end chip 4202 to trigger one or more interrupts at one or more processors (such as processor 4105) of sensor electronics 4106. The data inputs / outputs may be arranged to provide data to and / or receive data from sensor electronics 4106. In some examples, the data inputs / outputs may be arranged for bidirectional data transfer and may include, for example, MOSI inputs / outputs and MISO inputs / outputs. In some examples, data transferred from analog front-end chip 4202 to sensor electronics 4106 can be provided at MISO input / output, and data transferred from sensor electronics 4106 to analog front-end chip 4202 can be transferred via MOSI input / output.

[0354] The input and output terminals of the analog front-end chip 4202, used for communication with sensor electronics 4106, can be electrically coupled to connector 4130 and can be transmitted to and / or from sensor electronics 4106 via connector 4130. As described herein, the raw sensor signal provided to sensor electronics 4106 by analog front-end circuitry 4126 via connector 4130 can be a digital signal, thereby mitigating signal fragmentation at connector 4130.

[0355] Figure 42 The diagram also shows the input and output terminals of the analog front-end chip 4202 for interfacing with electrodes 4121, 4122, and 4124. The input and output terminals for interfacing with electrodes 4121, 4122, and 4124 can be analog input and output terminals. That is, for example, the signals transmitted at the input and output terminals for interfacing with electrodes 4121, 4122, and 4124 can be analog signals. Figure 42In the examples, these include a reference electrode input / output terminal (RE), a counter electrode input / output terminal (CE), a first working electrode input / output terminal (WE1), and a second working electrode input / output terminal (WE2). It should be understood that the inputs and outputs of the analog front-end circuitry 4126, used for interfacing with electrodes 4121, 4122, and 4124, can vary, for example, depending on the electrodes included in the analyte sensor 4104. Furthermore, in various examples, the analog front-end chip 4202 can receive inputs from various electrodes via the described inputs / outputs. For example, as described herein, the current provided by one or more working electrodes can indicate the analyte concentration at the analyte sensor 4104. Additionally, in some examples, the analog front-end circuitry 4126 can provide a bias signal to one or more of the electrodes.

[0356] Figure 42 Analog front-end components 4208 external to analog front-end chip 4202 are also shown. These include, for example, a capacitor C1 electrically coupled between ground and the regulator pin of analog front-end chip 4202. Additionally, capacitors C2 and C3 are electrically coupled between the input voltage VDD and the input voltage pin VDD of analog front-end chip 4202, as shown. Capacitors C1, C2, and C3 can provide power regulation on the voltage and ground lines of analog front-end chip 4202. It will be understood that various different configurations of power regulation capacitors and / or other components external to analog front-end chips (such as analog front-end chip 4202) can be present in various examples. In some examples, the power regulation capacitors can be fabricated on sensor substrate 4120 using printing or any other suitable technique. The connections between the various capacitors and the corresponding input / output terminals of analog front-end chip 4202 and the input voltage VDD can be provided by traces fabricated on sensor substrate 4120, as described herein.

[0357] Figure 43 This is a diagram illustrating an example arrangement of an analyzer sensor system 4300, including analog front-end circuitry 4326. Figure 43 In the example, the analyte sensor system 4300 includes an electrode subassembly 4306 arranged coaxially. For example, the electrodes of the electrode subassembly 4306 can be any suitable arrangement, such as, for example, the arrangement described herein, including relative to... Figure 3B , Figure 3C , Figures 15A to 15D , Figures 16A to 16D , Figures 17A to 17D , Figure 18 , Figure 19A , Figure 19B , Figure 20A and Figure 20BThe electrodes of electrode subassembly 4306 can be electrically coupled to sensor substrate 4320 and connectors 4302 and 4304. Connectors 4302 and 4304 can be any suitable connectors, including, for example, stamped metal type connectors. (Trace) Figure 43 (Not shown in the text) The electrodes of the electrode subassembly 4306 can be electrically coupled to the analog front-end circuit 4326, as described herein.

[0358] Figure 44 This is a diagram showing another example arrangement of the analyte sensor system 4300. Figure 44 Examples include connector portion 4308. In this example, connector portion 4308 may represent part of a zero insertion force (ZIF) connector. Connector portion 4308 may be coupled to a connector (such as connector 4130) to couple analog front-end circuitry 4326 to sensor electronics 4106. For example, sensor substrate 4320 may include traces electrically coupled to an input / output terminal of analog front-end circuitry 4326 that will interface with sensor electronics 4106.

[0359] Figure 45 This is a diagram illustrating another example arrangement of the analyzer sensor system 4500, including analog front-end circuitry 4526. Figure 45 In the example, the analyte sensor system 4500 includes an electrode subassembly 4506 having electrodes fabricated on a sensor substrate 4520. For example, the electrodes of the electrode subassembly 4506 can be arranged in any suitable manner, including, for example, as described herein with respect to... Figures 4A to 4G , Figures 5A to 5K , Figures 6A to 6E , Figures 7A to 7I , Figures 8A to 8F , Figure 9 , Figures 10A to 10B , Figures 11A to 11C , Figure 12 , Figure 13 , Figures 14A to 14D , Figure 21A , Figure 21B , Figures 22A to 22B , Figures 23A to 23D , Figures 24A to 24B , Figures 25A to 25E , Figures 26A to 26C , Figures 27A to 27D , Figures 28A to 28C , Figures 29 to 34 , Figures 35A to 35B , Figure 36 , Figures 37A to 37D and Figures 38 to 40 The methods described. Trajectory ( Figure 45 (Not shown in the text) The electrodes of the electrode subassembly 4506 can be electrically coupled to the analog front-end circuit 4526, as described herein.

[0360] exist Figure 45 In this example, the analog front-end circuitry 4526 is located within the housing 4510. The housing 4510 is mechanically coupled to the analog front-end circuitry 4526 and / or the sensor substrate 4520. Any suitable mechanical coupling can be used. In some examples, the housing 4510 snaps into the sensor substrate 4520. Furthermore, in some examples, the housing 4510 is bonded to the sensor substrate 4520 using an adhesive such as a suitable epoxy resin. Additionally, in some examples, the housing 4510 may be molded onto the sensor substrate. Figure 46 This is a diagram illustrating an example of an analyte sensor system 4500 including a housing 4510' molded onto a sensor substrate 4520. In various examples, as described herein, the housings 4510, 4510' can shield the analog connections between various electrodes and the analog front-end circuitry 4426 from moisture and other environmental conditions that may degrade the signal.

[0361] Figure 47 This is a diagram illustrating another example of the analyte sensor system 4500. Figure 47 In the example, analog front-end circuitry 4526 is shown removed from sensor substrate 4520. Sensor substrate 4520 includes connector portion 4508 for interfacing with connector 4130 to sensor electronics 4106, as described herein. Sensor substrate 4520 also includes pads 4512. Pads 4512 are arranged to interface with input / output terminals of analog front-end circuitry 4526. For example, analog front-end circuitry 4526 may be electrically coupled to a corresponding electrode of an electrode sub-command, and the focus will be shifted to a non-operating component 4506 via pads 4512. Additionally, for example, some pads may be electrically coupled to traces extending from the corresponding electrodes. In some examples, analog front-end circuitry 4526 may also be electrically coupled to connector portion 4508 via pads 4512. For example, sensor substrate 4520 may include one or more traces connecting one or more of pads 4512 to corresponding pads of connector portion 4508.

[0362] In an arrangement including analog front-end circuitry coupled to a sensor substrate, as described herein, the sensor substrate including the analog front-end circuitry can be electrically coupled to the sensor electronics in any suitable manner. For example, a connector (e.g., connector 4130) between the analyte sensor and the sensor electronics can be implemented using a connector portion electrically coupled to the analyte sensor and a connector portion electrically coupled to the sensor electronics. For example, Figure 44 and Figure 47 An arrangement in which a ZIF connector is used to electrically couple an analyte sensor (e.g., a sensor substrate) to sensor electronics is illustrated. Connector portions 4308 and 4508 of the analyte sensor can be configured to be electrically and mechanically coupled to corresponding connector portions at the sensor electronics.

[0363] In such as relative to Figure 2 The aforementioned arrangement, in which the analog front-end circuitry is part of the sensor electronics 106, and similar to... Figure 41 In the arrangement shown where the analog front-end circuitry 4126 is positioned on the analyte sensor 4104, transmitting signals from the analyte sensors 104, 4104 to the sensor electronics 106, 4106 can be challenging. For example, the connection between the analyte sensors 104, 4104 and the sensor electronics 106, 4106 may be sensitive to leakage, moisture, and other factors affecting noise. When the connection between the sensor electronics 106, 4106 and the analyte sensors 104, 4104 involves physical contact, it may be desirable for such connection (e.g., connector 4130) to be hermetically sealed. Contact-based hermetically sealed connectors can be bulky and costly to manufacture. This challenge can be addressed by placing the analog front-end circuitry 4126 at the analyte sensor 104, as described herein, because this allows digital signals, rather than analog signals, to pass through connector 4130. However, in some examples, the performance of the analyte sensor system can be further improved by utilizing contactless connections. For example, the analyte sensor 4104 can be operatively coupled (e.g., electrically coupled) to the sensor electronics 4106 using a contactless connection (e.g., wireless connection).

[0364] Figure 48 This is a diagram illustrating an example of an analyte sensor system 4800, which includes an analyte sensor 4104 electrically coupled to sensor electronics 4106 via a non-contact connector 4802. Figure 48 In the example, the analyzer sensor 4104 and sensor electronics 4106 are similar to Figure 41 Arranged as shown. For example, as... Figure 41 and Figure 48 As shown, the analog front-end circuit 4126 is located on the sensor substrate 4120.

[0365] The contactless connector 4802 can be any suitable type of contactless connector. For example, the contactless connector 4802 may include a sensor-side element 4804 and an electronics-side element 4806. The sensor-side element 4804 may be electrically coupled to the sensor 4104, for example, via analog front-end circuitry 4126. The electronics-side element 4806 may be electrically coupled to the sensor electronics 4106. The sensor-side element 4804 and the electronics-side element 4806 may be positioned substantially close to each other to facilitate wireless communication between the sensor-side element 4804 and the electronics-side element 4806. In some examples, the sensor-side element 4804 and the electronics-side element 4806 may be closely adjacent to each other and may include one or more coils, antennas, or other similar elements that may be positioned within the sensor system 4800 to allow the sensor-side element 4804 and the electronics-side element 4806 to be inductively coupled to each other without physical contact. Other antenna designs are contemplated to enable communication between the sensor system 4800 and the sensor-side element 4804.

[0366] Positioning the sensor-side element 4804 and the electronics-side element 4806 substantially close to each other may include bringing the sensor-side element 4804 and the electronics-side element 4806 close to each other and aligning the two elements 4804, 4806. For example, the sensor-side element 4804 and the electronics-side element 4806 may be positioned such that the elements 4804, 4806 substantially overlap each other and are placed close enough to each other that power and / or data signals can be wirelessly transmitted from one element 4804, 4806 and received by the other element 4804, 4806 to establish a wireless connection. After the sensor-side element 4804 and the transmitter-side element 4806 are aligned, power and / or data can be transmitted across the contactless connector 4802.

[0367] The contactless connector 4802 facilitates the transfer of data signals (e.g., unidirectional or bidirectional) and power between the analog front-end circuitry 4126 and the sensor electronics 4106. Data signals may include processed or unprocessed data. In this example, the digital output of the analog front-end circuitry 4126 may be generated, for example, by an analog-to-digital converter 4128. Data signals may also include, for example, clock signals, interrupt signals, etc. Power may be transferred, for example, from a battery 4114 via the contactless connector 4802. In some examples, the power requirements of the analyte sensor 4104 may be relatively small. In some cases, the distance between the sensor-side element 4804 and the electronics-side element 4806 of the contactless connector 4802 may be small, such as less than 10 mm, more preferably less than 5 mm, and even more preferably less than 1 mm. Power may be provided continuously or, in some cases, based on demand. It is conceivable that, in some examples, the contactless connector 4802 may be configured to operate for short-range communication, such as radio frequency identification (RFID) communication or near-field communication. In such examples, a suitable operating frequency can be selected for this type of operation (e.g., 13.56MHz, 433MHz, 860MHz-960MHz). Figure 48 In the example, analog front-end circuitry 4126 is located at analyte sensor 4104, and the signal across contactless connector 4802 is digital. It should be understood that in various examples, contactless connectors such as contactless connector 4802 can be used in arrangements where components of analog front-end circuitry 4126 are located at sensor electronics 4106 and the signal across contactless connector 4802 (entirely or partially) is analog, similar to... Figure 2 The arrangement shown.

[0368] Figure 49 This is a diagram illustrating one arrangement of an analyte sensor system 5000, which includes a sensor substrate 5020 on which a coil 5004 is positioned. In some examples, the coil 5004 includes traces positioned on the sensor substrate 5020 in the shape of a coil or other suitable shape for inductive coupling to electronic device-side elements. Figure 50 In the example, the analog front-end circuitry 5026 is also positioned on the sensor substrate 5020, as described herein. Figure 49 In this configuration, the analog sensor 5006 is located on the sensor substrate 5020. In this example, the analyte sensor 5006 is separated from the remainder of the sensor substrate 5020 via a notch 5008. The analyte sensor 5006 can be configured to bend downwards the remainder of the sensor substrate 5020 to facilitate insertion into a host body, as described herein.

[0369] Figure 50This is a diagram illustrating another arrangement of the analyte sensor system 5000, including sensor electronics 5010. As shown, sensor electronics 5010 includes an electronics-side coil 5022, which is positioned to be inductively coupled to sensor-side coil 5004. Figure 50 In the example, sensor electronics 5010 includes a battery 5024 and other components 5012, which may include any of the sensor electronics components described herein. Analog front-end circuitry 5026 is also shown. Furthermore, Figure 50 An analyte sensor 5006 is shown bent distally relative to the remainder of a sensor substrate 5020 inserted into a host tissue 5030.

[0370] In various examples, Figures 48 to 50 The non-contact connector arrangement shown eliminates the need for a seal between the sensor electronics and the analyte sensor, thereby improving noise performance, reducing size, and potentially lowering cost. In some examples, non-contact connector arrangements (such as...) Figures 48 to 50 The arrangement shown can be implemented in conjunction with a reusable transmitter. In a reusable transmitter arrangement, all or part of the sensor electronics are located within a housing or enclosure, such as... Figure 3A The electronic component unit 318 is shown. The transmitter housing or enclosure can be reused with multiple examples of the analyte sensor. For example, when a sensor session with an analyte sensor expires, the transmitter housing or enclosure (including the sensor electronics) can be removed from the analyte sensor and subsequently mechanically and electrically coupled to a new analyte sensor for a new sensor session. In some examples, the old sensor is disposable.

[0371] In some examples, the analyte sensor 104 and sensor electronics 4106 can be configured to begin operation upon the formation of the contactless connector 4802. For example, when the sensor-side element 4804 and the electronics-side element 4806 are positioned to form the contactless connector 4802, the sensor electronics 4106 can begin transmitting power to the analyte sensor 104. Similarly, after the contactless connector 4802 is formed, the analyte sensor 4104 can begin sending sensor signals to the sensor electronics 4106. In some examples, the formation of the contactless connector 4802 occurs when a reusable transmitter housing is mechanically coupled to the analyte sensor 104, thus positioning the sensor-side element 4804 and the electronics-side element 4806 to form the contactless connector 4802.

[0372] In some examples, in arrangements with reusable transmitters and disposable analyte sensors (e.g., relative to...) Figures 48 to 50The use of non-contact connectors can lead to simpler and cheaper designs for both components. For example, instead of separate electrical and mechanical coupling mechanisms, this arrangement can use a mechanical coupling arrangement that also aligns the sensor-side element 4804 and the electronics-side element 4806.

[0373] In some examples, sensor electronics may be fabricated on a sensor electronics substrate. The sensor electronics substrate may include a side-load connector portion. The side-load connector portion may receive an analyte sensor connector portion, such as, for example, one of connector portions 4308 and 4508 described herein.

[0374] In some examples, the connector portion at the analyte sensor may include multiple pins, and the connector portion at the sensor electronics may include multiple receptacles. The analyte sensor may be positioned such that the pins are mechanically received within the receptacles to create electrical and mechanical coupling between the analyte sensor and the sensor electronics. In some arrangements, the pins may include sharp ends. The receptacles may include a conductive elastomer. By pressing the sharp ends of the pins into the conductive elastomer, the connector portion from the analyte sensor can be coupled to the connector portion from the sensor electronics.

[0375] In some examples, the connector portion of the analyte sensor and / or the connector portion of the sensor electronics includes a flexible cable. The flexible cable may be made of wire and / or may be printed onto a flexible substrate. When the two connector portions are engaged, the flexible cable facilitates the positioning of the analyte sensor relative to the sensor electronics.

[0376] In some examples, the connector portion of the analyte sensor may include one or more conductive tabs. The connector portion of the sensor electronics may have corresponding conductive tabs. The corresponding conductive tabs may be arranged to be mechanically resilient. The analyte sensor and / or sensor electronics may additionally include a snap-fit ​​mechanism. When the conductive tab of the analyte sensor contacts the conductive tab of the sensor electronics, the corresponding tab provides resistance until the snap-fit ​​mechanism engages to hold the analyte sensor and sensor electronics in a mechanically coupled position. Electrical coupling between the analyte sensor and sensor electronics can be provided through the contact between the conductive tabs.

[0377] In some examples, the connector portion of the analyte sensor and / or the connector portion of the sensor electronics include gaskets or other similar sealing mechanisms. When the two connector portions come into contact, the gaskets or other similar sealing mechanisms can engage to protect the connection from moisture and / or other environmental factors.

[0378] In some examples, the connector portion of the analyte sensor and / or the connector portion of the sensor electronics may include a conductive adhesive film. When the two connector portions are brought into mechanical contact with each other, the conductive adhesive film can mechanically and electrically couple the connector portions.

[0379] Various notes and examples

[0380] Example 1 is a continuous analyte sensor, comprising: a substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; a first working electrode on the substrate; a second working electrode on the substrate; a reference electrode on the substrate, wherein the first working electrode, the second working electrode, and the reference electrode are all planar electrodes, wherein at least two of the first working electrode, the second working electrode, or the reference electrode are on the first side of the substrate, and any remaining planar electrodes are on the second side of the substrate, wherein at least two of the first working electrode, the second working electrode, and the reference electrode are coplanar with each other; and an interconnect extending through the substrate between the first side and the second side, the interconnect being electrically connected to one of the reference electrode, the first working electrode, or the second working electrode.

[0381] In Embodiment 2, the subject matter of Embodiment 1 optionally includes the first working electrode and the second working electrode being on the first side of the substrate, and the reference electrode being on the second side of the substrate.

[0382] In Embodiment 3, the subject matter of Embodiment 2 optionally includes the first working electrode and the second working electrode being coplanar with each other.

[0383] In Embodiment 4, the subject matter of any one or more of Embodiments 1 to 3 optionally includes the first working electrode and the reference electrode on the first side of the substrate, and the second reference electrode on the second side of the substrate.

[0384] In Example 5, the subject matter of Example 4 optionally includes the first working electrode and the reference electrode being coplanar with each other.

[0385] In Example 6, the subject matter of any one or more of Examples 1 to 5 optionally includes the first working electrode being spaced distally from the second working electrode on the substrate.

[0386] In Example 7, the subject matter of any one or more of Examples 1 to 6 optionally includes the first working electrode and the second working electrode each having substantially equal surface areas.

[0387] In Example 8, the subject matter of any one or more of Examples 1 to 7 optionally includes the reference electrode having a smaller surface area compared to the surface area of ​​either the first working electrode or the second working electrode.

[0388] In Example 9, the subject matter of any one or more of Examples 1 to 8 optionally includes a second reference electrode.

[0389] In Example 10, the subject matter of Example 9 optionally includes the first working electrode and the second working electrode on the first side of the substrate, and the first reference electrode and the second reference electrode on the second side of the substrate.

[0390] In Example 11, the subject matter of any one or more of Examples 1 to 10 optionally includes the first reference electrode having a smaller surface area compared to the surface area of ​​the second reference electrode.

[0391] In Example 12, the subject matter of any one or more of Examples 1 to 11 optionally includes a third working electrode, wherein the third working electrode is coplanar with at least one of the first working electrode, the second working electrode, or the reference electrode.

[0392] In Example 13, the subject matter of Example 12 optionally includes the first working electrode, the second working electrode, and the third working electrode being located on the first side of the substrate.

[0393] In Example 14, the subject matter of Example 13 optionally includes wherein the first working electrode and the second working electrode are spaced apart by a first distance on the substrate, and the second working electrode and the third working electrode are spaced apart by a second distance on the substrate.

[0394] In Example 15, the subject matter of Example 14 optionally includes the fact that the first distance and the second distance are substantially equal.

[0395] In Example 16, the subject matter of any one or more of Examples 12 to 15 optionally includes the first working electrode and the second working electrode on the first side of the substrate, and the third working electrode on the second side of the substrate.

[0396] In Example 17, the subject matter of any one or more of Examples 12 to 16 optionally includes the first working electrode, the second working electrode and the third working electrode each having substantially equal surface areas.

[0397] In Example 18, the subject matter of any one or more of Examples 1 to 17 optionally includes a first pair of electrodes, wherein the first pair of electrodes is a planar electrode.

[0398] In Example 19, the subject matter of Example 18 optionally includes the fact that the first pair of electrodes is coplanar with at least one of the first working electrode, the second working electrode, or the reference electrode.

[0399] In Example 20, the subject matter of any one or more of Examples 18 to 19 optionally includes the first working electrode and the second working electrode being on the first side of the substrate, and the reference electrode and the counter electrode being on the second side of the substrate.

[0400] In Example 21, the subject matter of Example 20 optionally includes wherein the counter electrode is spaced distally from the reference electrode on the substrate.

[0401] In Example 22, the subject matter of any one or more of Examples 18 to 21 optionally includes the fact that the counter electrode has a larger surface area than the reference electrode.

[0402] In Example 23, the subject matter of any one or more of Examples 18 to 22 optionally includes a second pair of electrodes, wherein both the first pair of electrodes and the second pair of electrodes are planar electrodes.

[0403] In Example 24, the subject matter of any one or more of Examples 1 to 23 optionally includes the alignment of the first working electrode, the second working electrode, and the reference electrode along the longitudinal direction of the substrate.

[0404] In Example 25, the subject matter of any one or more of Examples 1 to 24 optionally includes at least one analyte sensing membrane extending on one or more of the first working electrode and the second working electrode.

[0405] In Example 26, the subject matter of Example 25 optionally includes at least one analyte sensing membrane comprising an enzyme layer configured to sense glucose.

[0406] In Example 27, the subject matter of any one or more of Examples 25 to 26 optionally includes the at least one analyte sensing membrane comprising an enzyme layer configured to sense lactate.

[0407] In Example 28, the subject matter of any one or more of Examples 25 to 27 optionally includes the at least one analyte sensing membrane being configured to sense more than one analyte.

[0408] In Example 29, the subject matter of any one or more of Examples 1 to 28 optionally includes the fact that each of the first working electrode, the second working electrode and the reference electrode has a boundary on the substrate.

[0409] In Example 30, the subject matter of any one or more of Examples 1 to 29 optionally includes wherein the substrate includes an end portion extending distally from the first working electrode, the second working electrode and the reference electrode.

[0410] In Example 31, the subject matter of Example 30 optionally includes the substrate further comprising the end portion of the substrate excluding the first working electrode, the second working electrode and the reference electrode.

[0411] In Example 32, the subject matter of any one or more of Examples 30 to 31 optionally includes the end portion being perforated.

[0412] In Example 33, the subject matter of any one or more of Examples 30 to 32 optionally includes the fact that the end portion is rounded.

[0413] In Example 34, the subject matter of any one or more of Examples 30 to 33 optionally includes the end portion comprising a soft material.

[0414] In Example 35, the subject matter of any one or more of Examples 30 to 34 optionally includes the said end portion comprising a top cover fixed to the substrate at the distal end.

[0415] In Example 36, the subject matter of any one or more of Examples 30 to 35 optionally includes the fact that the end portion is flexible.

[0416] In embodiment 37, the subject matter of embodiment 36 optionally includes the end portion comprising a notch and a rounded portion, the rounded portion being spaced distally from the notch.

[0417] Example 38 is a sensor comprising: a substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; a first sensor system on the substrate, the first sensor system being a continuous analyte sensor configured to collect a first type of measurement, wherein the first sensor system includes: a working electrode; a reference electrode on the substrate, wherein both the working electrode and the reference electrode are planar electrodes; and at least one analyte sensing membrane extending over the at least one working electrode; and a second sensor system on the substrate, wherein the second sensor system is configured to collect a second type of measurement different from the first type of measurement.

[0418] In embodiment 39, the subject matter of embodiment 38 optionally includes the first sensor system comprising a current-type sensor.

[0419] In Example 40, the subject matter of Example 39 optionally includes the second sensor system comprising a potentiometric sensor.

[0420] In embodiment 41, the subject matter of embodiment 40 optionally includes the second sensor system comprising: a first electrode disposed on the substrate; an ion carrier disposed on the substrate and configured to selectively transport target ions to or within the first electrode; and a second electrode disposed on the substrate.

[0421] In Example 42, the subject matter of Example 41 optionally includes sensor electronics configured to: generate a first signal corresponding to a current response, the current response being at least partially based on a reaction at the working electrode corresponding to the concentration of a first analyte; and generate a second signal corresponding to an electromotive force, the electromotive force being at least partially based on a potential difference generated between the first electrode and the second electrode in response to the ion carrier transporting the target ion corresponding to the concentration of a second analyte to the first electrode.

[0422] In embodiment 43, the subject matter of any one or more of embodiments 41 to 42 optionally includes the first electrode of the second sensor system being on the first side of the substrate, and the second electrode of the second sensor system being on the second side of the substrate.

[0423] In embodiment 44, the subject matter of any one or more of embodiments 41 to 43 optionally includes the first sensor system being on the first side of the substrate and the second sensor system being on the second side of the substrate.

[0424] In Example 45, the subject matter of any one or more of Examples 41 to 44 optionally includes the first sensor system and the second sensor system both being located on the first side of the substrate.

[0425] In Example 46, the subject matter of any one or more of Examples 38 to 45 optionally includes a third sensor system.

[0426] In embodiment 47, the subject matter of embodiment 46 optionally includes the third sensor system being configured to collect a third type of measurement that is different from the first and second types of measurements.

[0427] In Example 48, the subject matter of any one or more of Examples 46 to 47 optionally includes the fact that the first sensor system and the third sensor system are current-type sensors.

[0428] In Example 49, the subject matter of any one or more of Examples 46 to 48 optionally includes the fact that the second sensor system and the third sensor system are potentiometric sensors.

[0429] In Example 50, the subject matter of any one or more of Examples 38 to 49 optionally includes the first sensor system comprising at least two working electrodes.

[0430] In Example 51, the subject matter of any one or more of Examples 38 to 50 may optionally include the first sensor system comprising at least three working electrodes.

[0431] In embodiment 52, the subject matter of any one or more of embodiments 38 to 51 optionally includes the first sensor system further comprising a counter electrode.

[0432] In embodiment 53, the subject matter of any one or more of embodiments 38 to 52 is optionally included, wherein the first sensor system further includes two counter electrodes.

[0433] In embodiment 54, the subject matter of any one or more of embodiments 38 to 53 optionally includes the first sensor system further comprising a second reference electrode.

[0434] In Embodiment 55, the subject matter of any one or more of Embodiments 38 to 54 optionally includes at least one interconnect extending between the first side and the second side of the substrate, the at least one interconnect being electrically connected to one of the reference electrode or the working electrode.

[0435] In Example 56, the subject matter of any one or more of Examples 38 to 55 optionally includes the fact that the working electrode and the reference electrode are coplanar with each other.

[0436] In Example 57, the subject matter of any one or more of Examples 38 to 56 optionally includes the fact that the working electrode is on the first side of the substrate and the reference electrode is on the second side of the substrate.

[0437] In Example 58, the subject matter of any one or more of Examples 38 to 57 optionally includes the working electrode and the reference electrode on the first side of the substrate.

[0438] Example 59 is a continuous analyte sensor comprising: a planar substrate having a distal portion and a proximal portion connected by a bonding portion, wherein the distal portion and the proximal portion are connected by the bonding portion at an angle between 70 degrees and 110 degrees; a first electrode on the distal portion of the substrate and a first connection pad on the proximal portion, the first electrode and the first connection pad being electrically coupled by a first trace wired through the bonding portion; a second electrode on the distal portion of the substrate and a second connection pad on the proximal portion, the second electrode and the second connection pad being electrically coupled by a second trace wired through the bonding portion; and at least one analyte sensing film extending over one or more of the first electrode and the second electrode.

[0439] In embodiment 60, the subject matter of embodiment 59 optionally includes the provision that the proximal portion has a width greater than that of the distal portion.

[0440] In Example 61, the subject matter of any one or more of Examples 59 to 60 optionally includes the provision that the proximal portion and the distal portion are substantially the same length.

[0441] In embodiment 62, the subject matter of any one or more of embodiments 59 to 61 optionally includes wherein the proximal portion includes a folded portion having a first planar portion and a second planar portion folded over the top of the first planar portion.

[0442] In embodiment 63, the subject matter of embodiment 62 optionally includes the first connecting pad and the second pad on the folded portion.

[0443] In embodiment 64, the subject matter of any one or more of embodiments 62 to 63 optionally includes the folded portion comprising an interconnect extending between each side of the folded portion, the interconnect being electrically connected to one of the first connecting pad or the second connecting pad.

[0444] In embodiment 65, the subject matter of any one or more of embodiments 59 to 64 optionally includes the fact that the proximal portion further includes a reinforcement.

[0445] In embodiment 66, the subject matter of any one or more of embodiments 59 to 65 optionally includes one or more additional electrical components on the distal portion.

[0446] In embodiment 67, the subject matter of any one or more of embodiments 59 to 66 optionally includes the fact that the first trace and the second trace are wired through the joint portion.

[0447] In Example 68, the subject matter of any one or more of Examples 59 to 67 optionally includes the fact that the first electrode and the second electrode are planar electrodes.

[0448] In Example 69, the subject matter of any one or more of Examples 59 to 68 optionally includes the fact that one of the first electrode or the second electrode is a working electrode.

[0449] In Example 70, the subject matter of any one or more of Examples 59 to 69 optionally includes the fact that one of the first electrode or the second electrode is a reference electrode.

[0450] In Example 71, the subject matter of any one or more of Examples 59 to 70 optionally includes a third electrode on the distal portion.

[0451] In Example 72, the subject matter of Example 71 optionally includes the third electrode comprising a working electrode, a reference electrode, or a counter electrode.

[0452] In embodiment 73, the subject matter of any one or more of embodiments 59 to 72 optionally includes the first electrode on a first side of the distal portion and the second electrode on a second side of the distal portion opposite to the first side.

[0453] In Example 74, the subject matter of any one or more of Examples 59 to 73 optionally includes the first electrode and the second electrode being coplanar with each other.

[0454] In Example 75, the subject matter of any one or more of Examples 59 to 74 optionally includes the at least one analyte sensing membrane comprising an enzyme layer configured to sense glucose.

[0455] In Example 76, the subject matter of any one or more of Examples 59 to 75 optionally includes the at least one analyte sensing membrane comprising an enzyme layer configured to sense lactate.

[0456] In Example 77, the subject matter of any one or more of Examples 59 to 76 optionally includes a third electrode, wherein the first electrode and the third electrode are working electrodes, and wherein the at least one analyte sensing membrane includes one or more enzyme layers configured to sense more than one analyte.

[0457] In Example 78, the subject matter of any one or more of Examples 59 to 77 optionally includes the planar substrate comprising the distal end portion of the first electrode and the second electrode.

[0458] Example 79 is a method for manufacturing a planar analyte sensor, the method comprising: stacking a first insulating material, a first conductive material, and a second conductive material on a first side of a substrate; exposing a portion of the first conductive material by selectively removing a plurality of portions of the first insulating material to form a first electrode; exposing a portion of the second conductive material by selectively removing a plurality of portions of the first insulating material to form a second electrode; stacking a second insulating material and a third conductive material on a second side of the substrate opposite to the first side; exposing a portion of the third conductive material by selectively removing a plurality of portions of the third insulating material to form a third electrode; and depositing an analyte sensing film onto either the first electrode, the second electrode, or the third electrode.

[0459] In Example 80, the subject matter of Example 79 optionally includes the deposition of the analyte sensing membrane comprising a jet valve dispensing the analyte sensing membrane.

[0460] In Example 81, the subject matter of any one or more of Examples 79 to 80 optionally includes the deposition of the analyte sensing film comprising slit molding.

[0461] In Example 82, the subject matter of any one or more of Examples 79 to 81 optionally includes the deposition of the analyte sensing film comprising screen printing.

[0462] In Example 83, the subject matter of any one or more of Examples 79 to 82 optionally includes a deposition of an analyte sensing membrane comprising a multilayer membrane having an enzyme layer containing one or more analyte-sensitive enzymes.

[0463] In Example 84, the subject matter of Example 83 optionally includes an additional enzyme layer containing one or more analyte-sensitive enzymes.

[0464] In Example 85, the subject matter of any one or more of Examples 83 to 84 optionally includes the enzyme layer being configured to detect glucose.

[0465] In Example 86, the subject matter of any one or more of Examples 83 to 85 is optionally included, wherein the intermediate layer is configured to detect lactate.

[0466] In Example 87, the subject matter of any one or more of Examples 79 to 86 optionally includes fabricating an interconnect that extends through the substrate from the first side to the second side, the interconnect being electrically connected to one of the first electrode, the second electrode, or the third electrode.

[0467] Example 88 is a method for manufacturing a plurality of analyte sensors, the method comprising: producing a plurality of sensor substrates from a substrate material sheet, wherein each of the plurality of sensor substrates is aligned on the substrate material sheet; forming a working electrode and a reference electrode on each of the plurality of sensor substrates; and applying an analyte sensitive film to each of the working electrodes on each of the plurality of sensor substrates.

[0468] In Example 89, the subject matter of Example 88 optionally includes the application of the analyte-sensitive membrane including injection valve dispensing.

[0469] In Example 90, the subject matter of any one or more of Examples 88 to 89 optionally includes the application of the analyte-sensitive membrane comprising slit-type molding.

[0470] In Example 91, the subject matter of any one or more of Examples 88 to 90 optionally includes the application of the analyte-sensitive membrane comprising screen printing.

[0471] In Example 92, the subject matter of any one or more of Examples 88 to 91 optionally includes slicing an analyte sensor from a substrate material sheet.

[0472] Example 93 is a method of manufacturing an analyte sensor, the method comprising: aligning a plurality of insulating layers and a plurality of conductive layers in an alternating manner; laminating the plurality of insulating layers and the plurality of conductive layers together; and exposing at least two electrodes by selectively removing a plurality of portions of the plurality of insulating layers.

[0473] In Example 94, the subject matter of Example 93 optionally includes electroplating the at least two electrodes.

[0474] In Example 95, the subject matter of any one or more of Examples 93 to 94 optionally includes rotary gravure printing of one of the at least two electrodes to form a reference electrode.

[0475] In Example 96, the subject matter of any one or more of Examples 93 to 95 optionally includes a laser scraping process in which at least two electrodes are exposed.

[0476] In Example 97, the subject matter of any one or more of Examples 93 to 96 optionally includes segmenting the analyte sensor from the plurality of insulating layers and the plurality of conductive layers.

[0477] In Example 98, the subject matter of any one or more of Examples 93 to 97 optionally includes the method described therein as a roll-to-roll method.

[0478] Example 99 is an analyte sensor comprising: a sensor substrate; a first electrode mechanically coupled to the sensor substrate; a first electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; a second electrode mechanically coupled to the sensor substrate; a second electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; and an analog front-end (AFE) circuit mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace.

[0479] In Example 100, the subject matter of Example 99 optionally includes the AFE circuit comprising an AFE substrate mechanically coupled to the sensor substrate.

[0480] In Embodiment 101, the subject matter of any one or more of Embodiments 99 to 100 optionally includes the AFE circuit comprising an analog-to-digital converter electrically coupled to convert an analog electrical signal generated by the first electrode and the second electrode into a digital signal.

[0481] In embodiment 102, the subject matter of embodiment 101 optionally includes an output connector to couple the analyte sensor to a sensor electronics assembly, the AFE circuit including: a first analog input terminal electrically coupled to the first electrode trace; a second analog input terminal electrically coupled to the second electrode trace; and at least one digital output terminal electrically coupled to the output connector.

[0482] In embodiment 103, the subject matter of embodiment 102 optionally includes the first analog input terminal and the second analog input terminal positioned on a first side of the AFE circuit, the first side of the AFE circuit being bonded to the sensor substrate.

[0483] In Example 104, the subject matter of any one or more of Examples 99 to 103 optionally includes the AFE circuit including a power input terminal, and the analyte sensor further including a first power regulating capacitor coupled to the sensor substrate and electrically connected to the power input terminal.

[0484] In Example 105, the subject matter of any one or more of Examples 99 to 104 optionally includes a housing mechanically coupled to the sensor substrate, with the AFE circuit located within the housing.

[0485] In Example 106, the subject matter of Example 105 optionally includes using an adhesive to bond the housing to the sensor substrate.

[0486] In Example 107, the subject matter of any one or more of Examples 105 to 106 optionally includes the housing being molded on the sensor substrate.

[0487] Example 108 is an analyte sensor system, comprising: an analyte sensor including: a sensor substrate; a first electrode mechanically coupled to the sensor substrate; a first electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; a second electrode mechanically coupled to the sensor substrate; a second electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; an analog front-end (AFE) circuit mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace; sensor electronics; and a connector electrically coupling the analog front-end circuit to the sensor electronics.

[0488] In embodiment 109, the subject matter of embodiment 108 optionally includes the connector being a zero input force (ZIF) connector.

[0489] In Example 110, the subject matter of any one or more of Examples 108 to 109 optionally includes the sensor electronics receiving at least one digital signal from the AFE across the connector.

[0490] In Example 111, the subject matter of any one or more of Examples 108 to 110 optionally includes the AFE circuit comprising an AFE substrate mechanically coupled to the sensor substrate.

[0491] In Embodiment 112, the subject matter of any one or more of Embodiments 108 to 111 optionally includes the AFE circuit comprising an analog-to-digital converter electrically coupled to convert an analog electrical signal generated by the first electrode and the second electrode into a digital signal.

[0492] In embodiment 113, the subject matter of embodiment 112 optionally includes an output connector to couple the analyte sensor to a sensor electronics assembly, the AFE circuit including: a first analog input terminal electrically coupled to the first electrode trace; a second analog input terminal electrically coupled to the second electrode trace; and at least one digital output terminal electrically coupled to the output connector.

[0493] In embodiment 114, the subject matter of embodiment 113 optionally includes the first analog input terminal and the second analog input terminal positioned on a first side of the AFE circuit, the first side of the AFE circuit being bonded to the sensor substrate.

[0494] In Example 115, the subject matter of any one or more of Examples 108 to 114 optionally includes the AFE circuit including a power input terminal, and the analyte sensor further including a first power regulating capacitor coupled to the sensor substrate and electrically connected to the power input terminal.

[0495] In Example 116, the subject matter of any one or more of Examples 108 to 115 optionally includes a housing mechanically coupled to the sensor substrate, with the AFE circuitry located within the housing.

[0496] In Example 117, the subject matter of Example 116 optionally includes using an adhesive to bond the housing to the sensor substrate.

[0497] In Example 118, the subject matter of any one or more of Examples 116 to 117 optionally includes the housing being molded on the sensor substrate.

[0498] In Embodiment 119, the subject matter of any one or more of Embodiments 108 to 118 optionally includes the connector comprising sensor-side contacts and electronics-side contacts, the sensor-side contacts and the electronics-side contacts being in physical contact with each other to electrically couple the analog front-end circuit to the sensor electronics.

[0499] In Example 120, the subject matter of any one or more of Examples 108 to 119 optionally includes the connector being a non-contact connector.

[0500] In embodiment 121, the subject matter of embodiment 120 optionally includes the connector comprising a sensor-side element and an electronic device-side element, the sensor-side element and the electronic device-side element being positioned to inductively couple the sensor-side element and the electronic device-side element.

[0501] In Example 122, the subject matter of any one or more of Examples 120 to 121 optionally includes the analyte sensor being configured to receive power from the sensor electronics via the non-contact connector.

[0502] Example 123 is a method for providing data from an analyte sensor to sensor electronics, the method comprising: positioning a sensor-side element of a non-contact connector and an electronics-side element of the non-contact connector to establish a wireless connection between the sensor-side element and the electronics-side element; transmitting power from the sensor electronics to the analyte sensor via the wireless connection; and transmitting data signals from the analyte sensor to the sensor electronics via the wireless connection.

[0503] In Example 124, the subject matter of Example 123 optionally includes the sensor electronics being positioned within an electronics unit housing, and the method further includes mechanically coupling the electronics unit housing to the analyte sensor, wherein the power transfer from the sensor electronics to the analyte sensor is responsive to the mechanical coupling.

[0504] In Example 125, the subject matter of any one or more of Examples 123 to 124 optionally includes the sensor electronics being positioned in an electronics unit housing, and the method further includes: mechanically coupling the electronics unit housing to the analyte sensor, wherein the transmission of the data signal from the sensor electronics to the analyte sensor is responsive to the mechanical coupling.

[0505] In Example 126, the subject matter of any one or more of Examples 123 to 125 optionally includes the data signal being a digital signal.

[0506] In Example 127, the subject matter of any one or more of Examples 123 to 126 optionally includes the data signal being an analog signal.

[0507] The above detailed description may include reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the subject matter of the invention is also contemplated to provide examples of only those elements shown or described. Furthermore, the subject matter of the invention is also contemplated to provide examples (or examples of one or more aspects thereof) of any combination or arrangement of those elements shown or described relative to a particular example (or one or more aspects thereof) or relative to other examples (or one or more aspects thereof) shown or described herein.

[0508] In the event of any inconsistency between the usage in this document and any other document incorporated herein by reference, the usage in this document shall prevail.

[0509] In this document, as is common in patent literature, the terms “a” or “an” are used to include one or more, independent of any other instances or uses of “at least one” or “one or more.” In this document, the term “or” is used to refer to a non-exclusive “or,” such that “A or B” may include “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as concise English equivalents to the corresponding terms “comprising” and “wherein.” Furthermore, in the appended claims, the terms “including” and “comprising” are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that may include elements other than those listed after such terms in the claims is still considered to fall within the scope of the claims. Additionally, in the appended claims, the terms “first,” “second,” and “third,” etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0510] The methods described herein can be implemented, at least in part, by a machine or computer. Some examples may include computer-readable or machine-readable media encoded with instructions operable to configure an electronic device to perform the methods described in the examples above. Specific implementations of such methods may include code, such as microcode, assembly language code, high-level language code, etc. Such code may include computer-readable instructions for performing various methods. This code may form part of a computer program product. Furthermore, in one example, the code may be tangibly stored, for example, during execution or at other times, on one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable disks, removable optical discs (e.g., compressed discs and digital video discs), magnetic tape cartridges, memory cards or memory sticks, random access memory (RAM), read-only memory (ROM), etc.

[0511] The above description is intended to be illustrative and not restrictive. For example, the examples (or one or more aspects thereof) described above may be used in combination with each other. Other embodiments may be used by those skilled in the art upon reviewing the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The submitted abstract should be understood as not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features may be combined to simplify this disclosure. This should not be construed as meaning that any unclaimed disclosed feature is necessary for any claim. Rather, the subject matter of the invention may lie in all features of fewer than those of a particular disclosed embodiment. Therefore, the appended claims are thus incorporated into the detailed description as examples or embodiments, wherein each claim is an independent, separate embodiment, and these embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of the equivalents granted by those claims.

Claims

1. A continuous analyte sensor, the continuous analyte sensor comprising: A substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; The first working electrode on the substrate; The second working electrode on the substrate; The reference electrode on the substrate, wherein the first working electrode, the second working electrode, and the reference electrode are all planar electrodes. The first working electrode, the second working electrode, or the reference electrode are all located on the first side of the substrate, and any remaining planar electrodes are located on the second side of the substrate. Wherein at least two of the first working electrode, the second working electrode, and the reference electrode are coplanar; and An interconnect extending through the substrate between the first side and the second side, the interconnect being electrically connected to one of the reference electrode, the first working electrode, or the second working electrode.

2. The continuous analyte sensor according to claim 1, wherein the first working electrode and the second working electrode are on the first side of the substrate, and the reference electrode is on the second side of the substrate.

3. The continuous analyte sensor according to claim 1, wherein the first working electrode and the second working electrode are coplanar.

4. The continuous analyte sensor according to any one of claims 1 to 2, wherein the first working electrode and the reference are on the first side of the substrate, and the second reference electrode is on the second side of the substrate.

5. The continuous analyte sensor according to claim 1, wherein the first working electrode and the reference electrode are coplanar.

6. The continuous analyte sensor according to any one of claims 1 to 5, wherein the first working electrode is spaced distally from the second working electrode on the substrate.

7. The continuous analyte sensor according to any one of claims 1 to 6, wherein the first working electrode and the second working electrode each have substantially equal surface areas.

8. The continuous analyte sensor according to any one of claims 1 to 7, wherein the reference electrode has a smaller surface area compared to the surface area of ​​either the first working electrode or the second working electrode.

9. The continuous analyte sensor according to any one of claims 1 to 8, further comprising a second reference electrode.

10. The continuous analyte sensor of claim 9, wherein the first working electrode and the second working electrode are on the first side of the substrate, and the first reference electrode and the second reference electrode are on the second side of the substrate.

11. The continuous analyte sensor according to any one of claims 1 to 10, wherein the first reference electrode has a smaller surface area compared to the surface area of ​​the second reference electrode.

12. The continuous analyte sensor according to any one of claims 1 to 11, further comprising a third working electrode, wherein the third working electrode is coplanar with at least one of the first working electrode, the second working electrode, or the reference electrode.

13. The continuous analyte sensor of claim 12, wherein the first working electrode, the second working electrode, and the third working electrode are on the first side of the substrate.

14. The continuous analyte sensor of claim 13, wherein the first working electrode and the second working electrode are spaced apart by a first distance on the substrate, and the second working electrode and the third working electrode are spaced apart by a second distance on the substrate.

15. The continuous analyte sensor of claim 14, wherein the first distance and the second distance are substantially equal.

16. The continuous analyte sensor of claim 12, wherein the first working electrode and the second working electrode are on the first side of the substrate, and the third working electrode is on the second side of the substrate.

17. The continuous analyte sensor of claim 12, wherein the first working electrode, the second working electrode and the third working electrode each have substantially equal surface areas.

18. The continuous analyte sensor according to any one of claims 1 to 17, further comprising a first pair of electrodes, wherein the first pair of electrodes is a planar electrode.

19. The continuous analyte sensor of claim 18, wherein the first pair of electrodes is coplanar with at least one of the first working electrode, the second working electrode, or the reference electrode.

20. The continuous analyte sensor of claim 18, wherein the first working electrode and the second working electrode are on the first side of the substrate, and wherein the reference electrode and the counter electrode are on the second side of the substrate.

21. The continuous analyte sensor of claim 20, wherein the counter electrode is spaced distally from the reference electrode on the substrate.

22. The continuous analyte sensor of claim 18, wherein the counter electrode has a larger surface area than the reference electrode.

23. The continuous analyte sensor according to claim 18 further includes a second pair of electrodes, wherein both the first pair of electrodes and the second pair of electrodes are planar electrodes.

24. The continuous analyte sensor according to any one of claims 1 to 23, wherein the first working electrode, the second working electrode and the reference electrode are aligned longitudinally along the substrate.

25. The continuous analyte sensor according to any one of claims 1 to 24, further comprising at least one analyte sensing membrane extending over one or more of the first working electrode and the second working electrode.

26. The continuous analyte sensor of claim 25, further comprising at least one analyte sensing membrane, said at least one analyte sensing membrane comprising an enzyme layer configured to sense glucose.

27. The continuous analyte sensor of claim 25, wherein the at least one analyte sensing membrane comprises an enzyme layer configured to sense lactate.

28. The continuous analyte sensor of claim 25, wherein the at least one analyte sensing membrane comprises a component configured to sense more than one analyte.

29. The continuous analyte sensor according to any one of claims 1 to 28, wherein each of the first working electrode, the second working electrode and the reference electrode has a boundary on the substrate.

30. The continuous analyte sensor according to any one of claims 1 to 29, wherein the substrate includes an end portion extending distally from the first working electrode, the second working electrode and the reference electrode.

31. The continuous analyte sensor of claim 30, wherein the substrate further comprises an end portion of the substrate excluding the first working electrode, the second working electrode and the reference electrode.

32. The continuous analyte sensor of claim 30, wherein the end portion is perforated.

33. The continuous analyte sensor of claim 30, wherein the end portion is rounded.

34. The continuous analyte sensor of claim 30, wherein the end portion comprises a soft material.

35. The continuous analyte sensor of claim 30, wherein the end portion includes a top cover fixed to the substrate at a distal end.

36. The continuous analyte sensor of claim 30, wherein the end portion is flexible.

37. The continuous analyte sensor of claim 36, wherein the end portion includes a notch and a rounded portion, the rounded portion being spaced distally from the notch.

38. A sensor, the sensor comprising: A substrate having a first side and a second side opposite to the first side, wherein the substrate is planar; A first sensor system on the substrate, the first sensor system being a continuous analyte sensor configured to collect measurements of a first type, wherein the first sensor system includes: Working electrode; The reference electrode on the substrate, wherein both the working electrode and the reference electrode are planar electrodes; and At least one analyte sensing membrane, the at least one analyte sensing membrane extending over the at least one working electrode; and The second sensor system on the substrate, wherein the second sensor system is configured to collect a second type of measurement different from the first type of measurement.

39. The sensor of claim 38, wherein the first sensor system comprises a current-type sensor.

40. The sensor of claim 39, wherein the second sensor system comprises a potentiometric sensor.

41. The sensor of claim 40, wherein the second sensor system comprises: A first electrode is disposed on the substrate; An ion carrier disposed on the substrate and configured to selectively transport target ions to or within the first electrode; as well as The second electrode is disposed on the substrate.

42. The sensor according to claim 41, further comprising: Sensor electronics, the sensor electronics being configured to: A first signal corresponding to a current response is generated, the current response being at least partially based on the reaction at the working electrode corresponding to the concentration of the first analyte; and A second signal corresponding to an electromotive force is generated, which is at least partially based on the potential difference generated between the first and second electrodes in response to the ion carrier transporting the target ion corresponding to the concentration of the second analyte to the first electrode.

43. The sensor of claim 41, wherein the first electrode of the second sensor system is on the first side of the substrate, and the second electrode of the second sensor system is on the second side of the substrate.

44. The sensor of claim 41, wherein the first sensor system is on the first side of the substrate, and the second sensor system is on the second side of the substrate.

45. The sensor of claim 41, wherein both the first sensor system and the second sensor system are located on the first side of the substrate.

46. ​​The sensor according to any one of claims 38 to 45, further comprising a third sensor system.

47. The sensor of claim 46, wherein the third sensor system is configured to collect a third type of measurement different from the first type and the second type of measurement.

48. The sensor according to claim 46, wherein the first sensor system and the third sensor system are current-type sensors.

49. The sensor according to claim 46, wherein the second sensor system and the third sensor system are potentiometric sensors.

50. The sensor according to any one of claims 38 to 49, wherein the first sensor system comprises at least two working electrodes.

51. The sensor according to any one of claims 38 to 50, wherein the first sensor system comprises at least three working electrodes.

52. The sensor according to any one of claims 38 to 51, wherein the first sensor system further comprises a counter electrode.

53. The sensor according to any one of claims 38 to 52, wherein the first sensor system further comprises two counter electrodes.

54. The sensor according to any one of claims 38 to 53, wherein the first sensor system further comprises a second reference electrode.

55. The sensor according to any one of claims 38 to 54, further comprising at least one interconnect extending between the first side of the substrate and the second side of the substrate, the at least one interconnect being electrically connected to one of the reference electrode or the working electrode.

56. The sensor according to any one of claims 38 to 55, wherein the working electrode and the reference electrode are coplanar.

57. The sensor according to any one of claims 38 to 56, wherein the working electrode is on the first side of the substrate and the reference electrode is on the second side of the substrate.

58. The sensor according to any one of claims 38 to 57, wherein the working electrode and the reference electrode are on the first side of the substrate.

59. A continuous analyte sensor, the continuous analyte sensor comprising: A planar substrate having a distal portion and a proximal portion connected by a joining portion, wherein the distal portion and the proximal portion are connected by the joining portion at an angle between 70 degrees and 110 degrees. A first electrode on the distal portion of the substrate and a first connection pad on the proximal portion are electrically coupled via a first trace wired through the junction portion. The second electrode on the distal portion of the substrate and the second connection pad on the proximal portion are electrically coupled by a second trace wired through the junction portion; as well as At least one analyte sensing membrane extends over one or more of the first electrode and the second electrode.

60. The continuous analyte sensor of claim 59, wherein the proximal portion has a width greater than that of the distal portion.

61. The continuous analyte sensor according to any one of claims 59 to 60, wherein the proximal portion and the distal portion are substantially the same length.

62. The continuous analyte sensor according to any one of claims 59 to 61, wherein the proximal portion includes a folded portion having a first planar portion and a second planar portion folded over the top of the first planar portion.

63. The continuous analyte sensor of claim 62, wherein the first connecting pad and the second pad are on the folded portion.

64. The continuous analyte sensor of claim 62, wherein the folded portion includes an interconnect extending between each side of the folded portion, the interconnect being electrically connected to one of the first connecting pad or the second connecting pad.

65. The continuous analyte sensor according to any one of claims 59 to 64, wherein the proximal portion further includes a reinforcement.

66. The continuous analyte sensor according to any one of claims 59 to 65, further comprising one or more additional electrical elements on the distal portion.

67. The continuous analyte sensor according to any one of claims 59 to 66, wherein the first trace and the second trace are wired through the junction portion.

68. The continuous analyte sensor according to any one of claims 59 to 67, wherein the first electrode and the second electrode are planar electrodes.

69. The continuous analyte sensor according to any one of claims 59 to 68, wherein one of the first electrode or the second electrode is a working electrode.

70. The continuous analyte sensor according to any one of claims 59 to 69, wherein one of the first electrode or the second electrode is a reference electrode.

71. The continuous analyte sensor according to any one of claims 59 to 70, further comprising a third electrode on the distal portion.

72. The continuous analyte sensor according to claim 71, wherein the third electrode comprises a working electrode, a reference electrode, or a counter electrode.

73. The continuous analyte sensor according to any one of claims 59 to 72, wherein the first electrode is on a first side of the distal portion, and the second electrode is on a second side of the distal portion opposite to the first side.

74. The continuous analyte sensor according to any one of claims 59 to 73, wherein the first electrode and the second electrode are coplanar with each other.

75. The continuous analyte sensor according to any one of claims 59 to 74, wherein the at least one analyte sensing membrane comprises an enzyme layer configured to sense glucose.

76. The continuous analyte sensor according to any one of claims 59 to 75, wherein the at least one analyte sensing membrane comprises an enzyme layer configured to sense lactate.

77. The continuous analyte sensor according to any one of claims 59 to 76, further comprising a third electrode, wherein the first electrode and the third electrode are working electrodes, and The at least one analyte sensing membrane includes one or more enzyme layers configured to sense more than one analyte.

78. The continuous analyte sensor according to any one of claims 59 to 77, wherein the planar substrate includes a distal end portion on the far side of the first electrode and the second electrode.

79. A method for manufacturing a planar analytical material sensor, the method comprising: A first insulating material, a first conductive material, and a second conductive material are stacked on a first side of the substrate; A first electrode is formed by selectively removing multiple portions of the first insulating material to expose a portion of the first conductive material. A second electrode is formed by selectively removing multiple portions of the first insulating material to expose a portion of the second conductive material; as well as A second insulating material and a third conductive material are stacked on the second side of the substrate opposite to the first side; A third electrode is formed by selectively removing multiple portions of the third insulating material to expose a portion of the third conductive material; as well as An analyte sensing film is deposited onto either the first electrode, the second electrode, or the third electrode.

80. The method of claim 79, wherein depositing the analyte sensing membrane includes dispensing the analyte sensing membrane using an injection valve.

81. The method according to any one of claims 79 to 80, wherein depositing the analyte sensing film comprises slit molding.

82. The method according to any one of claims 79 to 81, wherein depositing the analyte sensing film comprises screen printing.

83. The method according to any one of claims 79 to 82, wherein the deposition of the analyte sensing membrane comprises depositing a multilayer membrane having an enzyme layer comprising one or more analyte-sensitive enzymes.

84. The method of claim 83, further comprising an additional enzyme layer containing one or more analyte-sensitive enzymes.

85. The method of claim 83, wherein the enzyme layer is configured to detect glucose.

86. The method of claim 83, wherein the intermediate layer is configured to detect lactate.

87. The method of any one of claims 79 to 86, further comprising manufacturing an interconnect extending through the substrate from the first side to the second side, the interconnect being electrically connected to one of the first electrode, the second electrode, or the third electrode.

88. A method for manufacturing a plurality of analyte sensors, the method comprising: Multiple sensor substrates are produced from a substrate material sheet, wherein each of the multiple sensor substrates is aligned on the substrate material sheet; A working electrode and a reference electrode are formed on each of the plurality of sensor substrates; An analyte-sensitive membrane is applied to each of the working electrodes on each of the plurality of sensor substrates.

89. The method of claim 88, wherein applying the analyte-sensitive membrane includes dispensing via a jet valve.

90. The method according to any one of claims 88 to 89, wherein applying the analyte-sensitive membrane comprises slit-type molding.

91. The method according to any one of claims 88 to 90, wherein applying the analyte-sensitive membrane comprises screen printing.

92. The method according to any one of claims 88 to 91, further comprising slicing the analyte sensor from the substrate material sheet.

93. A method for manufacturing an analyte sensor, the method comprising: Multiple insulating layers and multiple conductive layers are aligned in an alternating manner; The plurality of insulating layers and the plurality of conductive layers are laminated together; as well as At least two electrodes are exposed by selectively removing multiple portions of the plurality of insulating layers.

94. The method of claim 93, further comprising electroplating the at least two electrodes.

95. The method according to any one of claims 93 to 94, further comprising performing rotary gravure printing on one of the at least two electrodes to form a reference electrode.

96. The method according to any one of claims 93 to 95, wherein exposing at least two electrodes comprises laser scraping.

97. The method according to any one of claims 93 to 96, further comprising separating the analyte sensor from the plurality of insulating layers and the plurality of conductive layers.

98. The method according to any one of claims 93 to 97, wherein the method is a roll-to-roll method.

99. An analyte sensor, the analyte sensor comprising: Sensor substrate; A first electrode, which is mechanically coupled to the sensor substrate; A first electrode trace, the first electrode trace being mechanically coupled to the sensor substrate and electrically coupled to the first electrode; A second electrode, which is mechanically coupled to the sensor substrate; A second electrode trace is mechanically coupled to the sensor substrate and electrically coupled to the first electrode; and An analog front-end (AFE) circuit is mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace.

100. The analyte sensor of claim 99, wherein the AFE circuit includes an AFE substrate mechanically coupled to the sensor substrate.

101. The analyte sensor according to any one of claims 99 to 100, wherein the AFE circuit includes an analog-to-digital converter electrically coupled to convert an analog electrical signal generated by the first electrode and the second electrode into a digital signal.

102. The analyte sensor of claim 101, further comprising an output connector for coupling the analyte sensor to sensor electronics, the AFE circuit comprising: A first analog input terminal, which is electrically coupled to the first electrode trace; The second analog input terminal is electrically coupled to the second electrode trace; as well as At least one digital output terminal, which is electrically coupled to an output connector.

103. The analyte sensor according to claim 102, wherein the first analog input terminal and the second analog input terminal are positioned on a first side of the AFE circuit, and the first side of the AFE circuit is bonded to the sensor substrate.

104. The analyte sensor according to any one of claims 99 to 103, wherein the AFE circuit includes a power input terminal, and the analyte sensor further includes a first power regulating capacitor coupled to the sensor substrate and electrically connected to the power input terminal.

105. The analyte sensor according to any one of claims 99 to 104, further comprising a housing mechanically coupled to the sensor substrate, the AFE circuit being positioned within the housing.

106. The analyte sensor of claim 105, wherein the housing is bonded to the sensor substrate using an adhesive.

107. The analyte sensor of claim 105, wherein the housing is molded on the sensor substrate.

108. An analyte sensor system, the analyte sensor system comprising: Analyte sensor, the analyte sensor comprising: Sensor substrate; A first electrode, which is mechanically coupled to the sensor substrate; A first electrode trace, the first electrode trace being mechanically coupled to the sensor substrate and electrically coupled to the first electrode; A second electrode, which is mechanically coupled to the sensor substrate; A second electrode trace, which is mechanically coupled to the sensor substrate and electrically coupled to the first electrode; and An analog front-end (AFE) circuit, the AFE circuit being mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace; and Sensor electronic components; and A connector that electrically couples the analog front-end circuitry to the sensor electronics.

109. The analyte sensor system of claim 108, wherein the connector is a zero-input-force (ZIF) connector.

110. The analyte sensor system according to any one of claims 108 to 109, wherein the sensor electronics receive at least one digital signal from the AFE across the connector.

111. The analyte sensor system according to any one of claims 108 to 110, wherein the AFE circuit includes an AFE substrate mechanically coupled to the sensor substrate.

112. The analyte sensor system according to any one of claims 108 to 111, wherein the AFE circuit includes an analog-to-digital converter electrically coupled to convert an analog electrical signal generated by the first electrode and the second electrode into a digital signal.

113. The analyte sensor system of claim 112, further comprising an output connector for coupling the analyte sensor to sensor electronics, the AFE circuit comprising: A first analog input terminal, which is electrically coupled to the first electrode trace; The second analog input terminal is electrically coupled to the second electrode trace; and At least one digital output terminal, which is electrically coupled to an output connector.

114. The analyte sensor system of claim 113, wherein the first analog input terminal and the second analog input terminal are positioned on a first side of the AFE circuit, and the first side of the AFE circuit is bonded to the sensor substrate.

115. The analyte sensor system according to any one of claims 108 to 114, wherein the AFE circuit includes a power input terminal, and the analyte sensor further includes a first power regulating capacitor coupled to the sensor substrate and electrically connected to the power input terminal.

116. The analyte sensor system according to any one of claims 108 to 115, further comprising a housing mechanically coupled to the sensor substrate, the AFE circuit being positioned within the housing.

117. The analyte sensor system of claim 116, wherein the housing is bonded to the sensor substrate using an adhesive.

118. The analyte sensor system of claim 116, wherein the housing is molded on the sensor substrate.

119. The analyte sensor system according to any one of claims 108 to 118, wherein the connector includes sensor-side contacts and electronics-side contacts, the sensor-side contacts and the electronics-side contacts being in physical contact with each other to electrically couple the analog front-end circuit to the sensor electronics.

120. The analyte sensor system according to any one of claims 108 to 119, wherein the connector is a non-contact connector.

121. The analyte sensor system of claim 120, wherein the connector includes a sensor-side element and an electronics-side element, the sensor-side element and the electronics-side element being positioned to inductively couple the sensor-side element and the electronics-side element.

122. The analyte sensor system of claim 120, wherein the analyte sensor is configured to receive power from the sensor electronics via the non-contact connector.

123. A method for providing data from an analyte sensor to sensor electronics, the method comprising: Position the sensor-side element of the non-contact connector and the electronic device-side element of the non-contact connector to generate a wireless connection between the sensor-side element and the electronic device-side element; Power is transmitted from the sensor electronics to the analyte sensor via the wireless connection; as well as Data signals are transmitted from the analyte sensor to the sensor electronics via the wireless connection.

124. The method according to claim 123, wherein the sensor electronics are positioned within an electronics unit housing, the method further comprising: The housing of the electronic device unit is mechanically coupled to the analyte sensor, and the power transfer from the sensor electronics to the analyte sensor is responsive to the mechanical coupling.

125. The method of claim 123, wherein the sensor electronics are positioned within an electronics unit housing, the method further comprising: The electronic device unit housing is mechanically coupled to the analyte sensor, and the transmission of the data signal from the sensor electronics to the analyte sensor is responsive to the mechanical coupling.

126. The method according to claim 123, wherein the data signal is a digital signal.

127. The method according to claim 123, wherein the data signal is an analog signal.

Images