Devices and methods for body fluid collection

Abstract

Provided herein are systems for measuring a health or physiological parameter of a subject comprising a primary or first reservoir, a secondary or second reservoir, and an injection patch. Further provided herein are methods for measuring a health or physiological parameter of a subject with the system herein, the method comprising securing the injection patch to the subject, transforming the injection patch into an activated configuration, and transforming the injection patch into a drug delivery configuration.

Description

DEVICES AND METHODS FOR BODY FLUID COLLECTIONCROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 664,865, filed June 27, 2024, which is entirely incorporated herein by reference.BACKGROUND

[0002] Vials are one of the preferred reservoirs or container closure systems used by the pharmaceutical industry due to their extensive clinical history and record of long-term stability with a wide variety of drugs. Pharmaceutical drugs including biologies are typically provided in standard containers such as vials. Additionally, the industry has made a significant investment in capital equipment for aseptic vial filling. However, vials require the transfer of the contained drug from the vial to an injection device (e.g., injector, autoinjector, infuser, etc.) for delivery to a patient. New container closure systems such as prefilled syringes and cartridges have been introduced that allow direct transfer of the drug from the syringe or cartridge to the patient. Injection devices such as auto-injectors and pens have been developed to utilize these newer forms of container closure. Because of uncertainty about long-term drug stability, and the extensive manufacturing resources already in place, devices that incorporate standard container closure systems such as vials, prefilled syringes or cartridges are greatly preferred by the pharmaceutical industry over devices that require a custom form of drug containment.

[0003] However, vials, prefilled syringes, and cartridges are not necessarily the optimum containers for a drug delivery device. This is especially true in the case of delivery devices that deliver relatively high volumes of drugs (e.g., 2-50 cc) or drugs with high viscosity (e.g., over 15 cP and up to about 100 cP). Vials, prefilled syringes, and cartridges are almost exclusively cylinders made of glass, which imposes design constraints on forces and geometries. Typical syringes and auto-injectors are limited on the viscosities of drug that can be delivered as well as by the forces that can be applied to the glass container closure systems. New injection devices have been developed including pumps for the delivery of therapeutics such as insulin that use custom container closures, but these systems are very expensive, cannot generate high forces or pressures, and typically are not reusable and / or refillable.

[0004] On-body injection devices have been the subject of continuing development in efforts to develop injection devices and methods that offer benefits such as greater comfort and less pain while providing effective subcutaneous injection.SUMMARY

[0005] Provided herein are systems and methods for measuring a health or physiological parameter of a subject. During an injection (or infusion or delivery) of a medicament (drug or drug product), a body fluid sample (e.g., blood, interstitial fluid, or sweat) may be drawn to detect an analyte. The analyte may be indicative of a response of the subject to the medicament. The body fluid sample collection may be performed with a device that is independent from the injection device. The systems and methods disclosed herein provide integrated solution such that no separate collection device is needed. The body fluid sample collection may be integrated with an injection device. Further, the injection device may comprise one or more sensors configured to measure one or more characteristics of the body fluid sample. The one or more sensors may provide real-time output indicative of a response of the subject to the injection of the medicament. Alternatively, the injection device may comprise a reservoir to store the collected body fluid sample and the body fluid sample may be processed and analyzed offsite, e.g., at a remote facility.

[0006] In an aspect, the present disclosure provides a system for measuring a health or physiological parameter of a subject, comprising: (a) a primary reservoir (or first reservoir, used interchangeably in the present disclosure) configured to store a fluid sample of the subject; (b) a secondary reservoir (or second reservoir, used interchangeably in the present disclosure) configured to store a drug product; and (c) an injection patch configured to be secured to the subject, the injection patch comprising an injector comprising a primary needle (or first needle, used interchangeably in the present disclosure), wherein: (i) in a storage configuration of the injection patch, a proximal tip of the primary needle is within the injection patch, (ii) in an activated configuration of the injection patch, the fluid sample is drawn from the subject into the primary reservoir; and (iii) in a drug delivery configuration of the injection patch, the drug product is injected into the subject.

[0007] In some embodiments, the primary reservoir, the secondary reservoir, or both, are removably coupled to the injector, the injection patch, or both. In some embodiments, the primary reservoir, the secondary reservoir, or both, decouple from the injector, the injection patch, or both once the drug product is injected into the subject through the primary needle. In some embodiments, the primary reservoir, the secondary reservoir, or both, decouple from the injector, the injection patch, or both by a threaded coupling, a sliding coupling, a snapping coupling, a locking coupling, or any combination thereof. In some embodiments, the primary reservoir, the secondary reservoir, or both, decouple from the injector, the injection patch, or both once being unlocked from the injection patch, the injector, or both. In some embodiments,the primary reservoir, the secondary reservoir, or both and the injection patch, the injector, or both comprise a locking mechanism. In some embodiments, the primary reservoir, the secondary reservoir, or both, are rigidly coupled to the injector, the injection patch, or both. In some embodiments, the primary reservoir, the secondary reservoir, or both, comprises a wicking material, a lateral flow strip, a sample slide, a vacutainer, or any combination thereof. In some embodiments, the injection patch comprises a housing, wherein the primary reservoir, the secondary reservoir, or both, are removably coupled to the housing. In some embodiments, the housing of the injection patch is configured to be secured to the subject. In some embodiments, the housing of the injection patch encloses at least a portion of the primary reservoir, at least a portion of the secondary reservoir, the injector, or any combination thereof. In some embodiments, the system further comprises a plurality of the primary reservoirs, wherein each of the plurality of the primary reservoirs is configured to store a portion of the fluid sample of the subject. In some embodiments, at least a portion of the plurality of the primary reservoirs are formed in a primary reservoir device. In some embodiments, the primary reservoir device is rotatably and removably coupled to the injection patch. In some embodiments, the system further comprises a bearing, a shaft, a ratchet, or any combination thereof coupling the primary reservoir device to the injection patch. In some embodiments, the injection patch is configured to be secured to the primary reservoir, wherein the primary reservoir is configured to be secured to the subject.

[0008] In some embodiments, in the activated configuration of the injection patch, at least a portion of the primary needle extends into or through the secondary reservoir. In some embodiments, in the activated configuration of the injection patch, a proximal tip of the primary needle extends into the tissue of the subject to collect the fluid sample. In some embodiments, the system further comprises a sensor measuring a property of the fluid sample, a presence of the fluid sample, or both. In some embodiments, the system further comprises a non-transitory computer-readable storage media encoded with a computer program including instructions executable by a processor to analyze the measured property to determine the health or physiological parameter. In some embodiments, the system further comprises a communication device transmitting the measured property. In some embodiments, the system further comprises a communication device transmitting the health or physiological parameter. In some embodiments, the system further comprises a valve fluidically coupled to the primary needle, the primary reservoir, the secondary reservoir, or any combination thereof. In some embodiments, the secondary reservoir comprises a secondary needle (or second needle, used interchangeably in the present disclosure), wherein in the drug delivery configuration of the injection patch, thedrug product is injected into the subject through the secondary needle.

[0009] In another aspect, the present disclosure provides a method for measuring a health or physiological parameter of a subject, the method comprising: (a) providing a system disclosed herein; (b) securing the injection patch to the subject; (c) transforming the injection patch into the activated configuration; and (d) transforming the injection patch into the drug delivery configuration.

[0010] In some embodiments, step (d) is performed before step (c). In some embodiments, step (d) is performed after step (c). In some embodiments, the method further comprises (e) unlocking the primary reservoir, the secondary reservoir, or both from the injection patch. In some embodiments, the method further comprises (f) removing the primary reservoir, the secondary reservoir, or both from the injection patch.

[0011] In some embodiments, the method further comprises measuring a property of the fluid sample. In some embodiments, the method further comprises analyzing the measured property to determine the health or physiological parameter. In some embodiments, the method further comprises transmitting the measured property, the health or physiological parameter, or both.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0013] FIG. 1A shows a front cross-sectional view of an exemplary first system for measuring a health or physiological parameter of a subject, wherein the first injection patch is in a storage configuration, according to one or more embodiments herein;

[0014] FIG. IB shows a front cross-sectional view of an exemplary first system for measuring a health or physiological parameter of a subject, wherein the first injection patch is in an activated configuration, according to one or more embodiments herein;

[0015] FIG. 1C shows a front cross-sectional view of an exemplary first system for measuring a health or physiological parameter of a subject, wherein the first injection patch is in a drug delivery configuration, according to one or more embodiments herein;

[0016] FIG. ID shows a front cross-sectional view of an exemplary first system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir is removed, according to one or more embodiments herein;

[0017] FIG. 2A shows a front cross-sectional view of an exemplary second system formeasuring a health or physiological parameter of a subject, wherein the second injection patch is in a drug delivery configuration, according to one or more embodiments herein;

[0018] FIG. 2B shows a front cross-sectional view of an exemplary second system for measuring a health or physiological parameter of a subject, wherein the second injection patch is in an activated configuration, according to one or more embodiments herein;

[0019] FIG. 2C shows a front cross-sectional view of an exemplary second system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir is being removed from the injection patch, according to one or more embodiments herein;

[0020] FIG. 2D shows a front cross-sectional view of an exemplary second system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir is removed, according to one or more embodiments herein;

[0021] FIG. 3A shows a front cross-sectional view of an exemplary third system for measuring a health or physiological parameter of a subject, wherein the third injection patch is in a storage configuration, according to one or more embodiments herein;

[0022] FIG. 3B shows a front cross-sectional view of an exemplary third system for measuring a health or physiological parameter of a subject, wherein the third injection patch is in a drug delivery configuration, according to one or more embodiments herein;

[0023] FIG. 3C shows a front cross-sectional view of an exemplary third system for measuring a health or physiological parameter of a subject, after the third injection patch is in the drug delivery configuration, according to one or more embodiments herein;

[0024] FIG. 3D shows a front cross-sectional view of an exemplary third system for measuring a health or physiological parameter of a subject, wherein the third injection patch is in an activated configuration, according to one or more embodiments herein;

[0025] FIG. 3E shows a front cross-sectional view of an exemplary system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir decouples from the fourth injector by a sliding feature, according to one or more embodiments herein;

[0026] FIG. 3F shows a front cross-sectional view of an exemplary system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir, the secondary or second reservoir, and the injector decouple from the case, according to one or more embodiments herein;

[0027] FIG. 4A shows a front cross-sectional view of an exemplary fourth system for measuring a health or physiological parameter of a subject, wherein the fourth patch is in a storage configuration, according to one or more embodiments herein;

[0028] FIG. 4B shows a front cross-sectional view of an exemplary fourth system for measuringa health or physiological parameter of a subject, wherein the fourth patch is in the drug delivery configuration, according to one or more embodiments herein;

[0029] FIG. 4C shows a front cross-sectional view of an exemplary fourth system for measuring a health or physiological parameter of a subject, wherein the fourth patch is in an activated configuration, according to one or more embodiments herein;

[0030] FIG. 4D shows a front cross-sectional view of an exemplary fourth system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir is removed from the injection patch, according to one or more embodiments herein;

[0031] FIG. 4E shows a top view of an exemplary primary or first reservoir, according to one or more embodiments herein;

[0032] FIG. 5A shows a front cross-sectional view of an exemplary fifth system for measuring a health or physiological parameter of a subject comprising a primary or first reservoir device with its primary or first reservoir filled with a fluid sample, according to one or more embodiments herein;

[0033] FIG. 5B shows a top cross-sectional view of an exemplary primary or first reservoir device with its primary or first reservoir filled with a fluid sample, according to one or more embodiments herein;

[0034] FIG. 5C shows a front cross-sectional view of an exemplary fifth system for measuring a health or physiological parameter of a subject, wherein the primary or first reservoir device is removed, according to one or more embodiments herein;

[0035] FIG. 5D shows a top cross-sectional view of the exemplary primary or first reservoir device with four reservoirs filled with a fluid sample, according to one or more embodiments herein;

[0036] FIG. 6 shows a front cross-sectional view of an exemplary system for measuring a health or physiological parameter of a subject comprising a non-transitory computer-readable storage media, an analysis chip, and a communication device, according to one or more embodiments herein;

[0037] FIG. 7 shows a diagram of an exemplary method for measuring a health or physiological parameter of a subject, according to one or more embodiments herein; and

[0038] FIG. 8 shows a non-limiting example of a computing device; in this case, a device with one or more processors, memory, storage, and a network interface.DETAILED DESCRIPTION

[0039] Recognized herein is a need for new and / or improved apparatuses, systems, and methods for injection of medicaments (e.g., drugs or drug products) from a reservoir, e.g., source vial orvials, to and into a subject. Further, recognized herein is a need for apparatuses, systems, and methods for monitoring a health or physiologic parameter prior to, during, and / or following an injection of a medicament into a subject. Such an apparatus or system may be useful, for example, in clinical trials, such as for regulatory approval, and patient monitoring.

[0040] The present disclosure provides apparatuses, systems, and methods that may be used for medical fluid transfer and injection, and methods for administering a substance (e.g., medicament or drug or drug product, as used interchangeably herein) to a subject and monitoring the subject for one or more physical parameters or attributes before, during, and / or after the administration of the substance. The present disclosure provides devices, methods, and systems for delivering a substance (e.g., a medicament) to a subject and monitoring the subject prior to, concurrently with, and / or subsequent to delivering the substance. A device of the disclosure may comprise an injection patch comprising an injector that delivers the medicament. Alternatively, or in addition to, the device may comprise a sensing patch that is configured to monitor the subject and / or communicate with the injector or injection patch. In some embodiments, the subject is monitored by collecting a fluid sample from the subject with the injection patch and performing one or more measurements on the fluid sample. In some embodiments, the fluid sample comprises blood, interstitial fluid, sweat, and / or other bodily fluids. In some embodiments, the fluid sample is collected in a reservoir. The fluid sample may be measured with one or more measurement elements or sensors on-board the injection patch or with one or more external measurement elements or sensors, such as in the case of a removable fluid sample reservoir or separable sensing patch and injection patch. In some examples, the injection patch and sensing patch are separate devices (e.g., separable from each other). As an alternative, the injection patch and sensing patch may be part of single device (e.g., not separable from each other). In some examples, the fluid sample reservoir is part of the single device (e.g., not separable from the injection patch and sensing patch) or may be a separate device (e.g., separable from one or both of the injection patch or sensing patch).Systems for Measuring a Health or Physiological Parameter of a Subject

[0041] Provided herein is a system for measuring a health or physiological parameter of a subject. In some embodiments, the system may comprise a primary reservoir (or “first reservoir”, used interchangeably in the present disclosure). In some embodiments, the system may comprise a secondary reservoir (or “second reservoir”, used interchangeably in the present disclosure). In some embodiments, the system may comprise an injection patch.

[0042] In some embodiments, the primary or first reservoir is configured to store a fluid sample of the subject. In some embodiments, the primary or first reservoir is configured to store thefluid sample in an airtight cavity. In some embodiments, the primary or first reservoir comprises a seal, a detector of the fluid sample, or both. In some embodiments, the primary or first reservoir is configured to store at least about 0.001 mL, at least about 0.002 mL, at least about 0.004 mL, at least about 0.006 mL, at least about 0.008 mL, at least about 0.01 mL, at least about 0.02 mL, at least about 0.04 mL, at least about 0.06 mL, at least about 0.08 mL, at least about 0.1 mL, at least about 0.2 mL, at least about 0.3 mL, at least about 0.4 mL, at least about 0.5 mL, at least about 0.6 mL, at least about 0.7 mL, at least about 0.8 mL, at least about 0.9 mL, at least about 1 mL, or more including increments therein of the fluid sample.

[0043] In some embodiments, the secondary or second reservoir is configured to store a drug product. In some embodiments, the secondary or second reservoir is configured to store the drug product in an airtight cavity. In some embodiments, the secondary or second reservoir comprises a seal, a detector of the drug product, or both. In some embodiments, the secondary or second reservoir is configured to store at least about 0.01 mL, at least about 0.02 mL, at least about 0.04 mL, at least about 0.06 mL, at least about 0.08 mL, at least about 0.1 mL, at least about 0.2 mL, at least about 0.3 mL, at least about 0.4 mL, at least about 0.5 mL, at least about 0.6 mL, at least about 0.7 mL, at least about 0.8 mL, at least about 0.9 mL, at least about 1 mL, at least about 2 mL, at least about 3 mL, at least about 4 mL, at least about 5 mL, at least about 10 mL, at least about 15 mL, at least about 20 mL, or more including increments therein of the drug product.

[0044] In some embodiments, a drug product can comprise an aqueous based drug. In some embodiments, the drug product can comprise a drug for subcutaneous injection. In some embodiments, the drug product may be used for treating diseases in a range of therapeutics areas including but not limited to cardiovascular, musculoskeletal, gastrointestinal, dermatology, immunology, ophthalmology, hematology, neuroscience, oncology, endocrinology / metabolic and respiratory. In some embodiments, the drug product may be used to treat discomfort or pain of the subject. In some embodiments, the drug product may comprise an analgesic, non-steroidal inflammatory drug (NS AID), or other pain-reducing, pain-alleviating, or other pain management substance. In some embodiments, the drug product can comprise a drug for treating diabetes. In some embodiments, the drug product can comprise insulin. In some embodiments, the drug product can comprise an incretin. In some embodiments, the drug product can comprise glucagon-like peptide-1 (GLP-1) agonists, e.g., dulaglutide (Trulicity), bydureon bcise, exenatide (Byetta), Semaglutide (Ozempic), Liraglutide (Victoza, Saxenda), and Lixisenatide (Adlyxin). In some embodiments, the drug product can comprise a drug to reduce blood clotting. In some embodiments, the drug product can comprise heparin. In some embodiments, the drug product can comprise a low molecular weight heparin, e.g., enoxaparin. In some embodiments,the drug product can comprise a human growth hormone, e.g., somatropin. In some embodiments, the drug product can comprise a fertility drug, e.g., ganirelix, menotropins, and human chorionic gonadotropin. In some embodiments, the drug product can comprise a drug to treat allergic reactions, e.g., epinephrine. In some embodiments, the drug product can comprise a drug for immunotherapies. In some embodiments, the drug product can comprise interferons or monoclonal antibodies, e.g., adalimumab, omalizumab, mepolizumab, and reslizumab.

[0045] In some embodiments, the injection patch is configured to be secured to the subject. In some embodiments, the injection patch is configured to be secured to the subject by an adhesive, a strap, a clamp, suction, or any combination thereof. In some embodiments, the injection patch is configured to be removably secured to the subject. In some embodiments, the injection patch is configured to be resecured to the subject.

[0046] In some embodiments, the injection patch comprises an injector. In some embodiments, the injector comprises a primary needle (or “first needle”, used interchangeably in the present disclosure). In some embodiments, the injector is configured to translate the primary or first needle towards the subject such that the primary or first needle pierces the skin of the subject. In some embodiments, the injector comprises a spring, a band, a gear, a motor, a pump, a reservoir for compressed air, a pulley, a sprocket, or any combination thereof. In some embodiments, the injector is configured to translate the primary or first needle in a direction from about 45 degrees to about 90 degrees relative to the skin surface of the subject when the injection patch is secured to the subject. In some embodiments, the injector is configured to translate the primary or first needle in a direction substantially perpendicular to the skin surface of the subject when the injector is secured to the subject.

[0047] In some embodiments, in a storage configuration of the injection patch, a proximal tip of the primary or first needle is within the injection patch. In some embodiments, in the storage configuration of the injection patch, the primary or first needle is outside the secondary or second reservoir. In some embodiments, in an activated configuration of the injection patch, the fluid sample is drawn from the subject into the primary or first reservoir. In some embodiments, in an activated configuration of the injection patch, the fluid sample is drawn from the subject through the primary or first needle and into the primary or first reservoir. In some embodiments, in an activated configuration of the injection patch, the injector draws the fluid sample. In some embodiments, in the activated configuration of the injection patch, at least a portion of the primary or first needle extends into or through the secondary or second reservoir. In some embodiments, in the activated configuration of the injection patch, a proximal tip of the primary or first needle extends into the tissue of the subject to collect the fluid sample. In someembodiments, in a drug delivery configuration of the injection patch, the drug product is injected into the subject.

[0048] In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, are removably coupled to the injector, the injection patch, or both. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, decouple from the injector, the injection patch, or both by a threaded coupling, a sliding coupling, a snapping coupling, a locking coupling, or any combination thereof. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, couple to the injector, the injection patch, or both by a threaded feature, a sliding feature, a magnet, a spring, a flexure, or any combination thereof. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, decouple from the injector, the injection patch, or both once the drug product is injected into the subject through the primary or first needle. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, decouple from the injector, the injection patch, or both only once the drug product is injected into the subject through the primary or first needle. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, decouple from the injector, the injection patch, or both once being unlocked from the injection patch, the injector, or both. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both and the injection patch, the injector, or both comprise a locking mechanism. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, are rigidly coupled to the injector, the injection patch, or both. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, comprises a wicking material, a lateral flow strip, a sample slide, a vacutainer, or any combination thereof.

[0049] In some embodiments, the injection patch comprises a housing. In some embodiments, the primary or first reservoir, the secondary or second reservoir, or both, are removably coupled to the housing. In some embodiments, the housing of the injection patch is configured to be secured to the subject. In some embodiments, the housing of the injection patch encloses at least a portion of the primary or first reservoir, the secondary or second reservoir, the injector, or any combination thereof. In some embodiments, the housing of the injection patch is waterproof.

[0050] In some embodiments, the system comprises a plurality of the primary or first reservoirs. In some embodiments, each of the plurality of the primary or first reservoirs is configured to store a portion of the fluid sample of the subject. In some embodiments, the plurality of the primary or first reservoirs comprises 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more of the primary or first reservoirs. In some embodiments, at least a portion of the plurality of the primary or firstreservoirs is formed in a primary or first reservoir device. In some embodiments, the primary or first reservoir device is rotatably and removably coupled to the injection patch. In some embodiments, the system further comprises a bearing, a shaft, a ratchet, or any combination thereof coupling the primary or first reservoir device to the injection patch. In some embodiments, the injection patch is configured to be secured to the primary or first reservoir, and the primary or first reservoir is configured to be secured to the subject. In some embodiments, the secondary or second reservoir comprises a secondary or second needle, wherein the drug delivery configuration of the injection patch, the drug product is injected into the subject through the secondary or second needle.

[0051] In some embodiments, the system further comprises a valve fluidically coupled to the primary or first needle, the secondary or second needle, the primary or first reservoir, the secondary or second reservoir, or any combination thereof. In some embodiments, the valve fluidically couples the primary or first reservoir, the secondary or second reservoir, or both to the primary or first needle. In some embodiments, the valve fluidically decouples the primary or first reservoir, the secondary or second reservoir, or both from the primary or first needle. In some embodiments, the valve fluidically couples the primary or first reservoir, the secondary or second reservoir, or both to the secondary or second needle. In some embodiments, the valve fluidically decouples the primary or first reservoir, the secondary or second reservoir, or both from the secondary or second needle. In some embodiments, the valve fluidically encloses the primary or first reservoir, the secondary or second reservoir, or both.

[0052] In some embodiments, the system is labeled with a marker unique to the subject, the drug product, or both. In some embodiments, the system is labeled by an RFID chip, a barcode, a Bluetooth device, or any combination thereof.

[0053] In some embodiments, as shown in FIG. 6, the system 600 further comprises a sensing patch comprising one or more sensors 630 configured to measure a property of the fluid sample, a presence of the fluid sample, or both. In some embodiments, the one or more sensors 630 comprise a thermal sensor, a mass sensor, an electrochemical sensor, an optical sensor, or any combination thereof. In some embodiments, the thermal sensor comprises a thermistor, a pyroelectric sensor, a micro bio-sensor, or any combination thereof. In some embodiments, the electrochemical sensor comprises a potentiometry sensor, an amperometry sensor, a conductivity sensor, a flow rate sensor, or any combination thereof. In some embodiments, the property of the fluid sample comprises a density, a viscosity, a salinity, a pH, an acidity, a concentration of an element or compound, a concentration of a chemical or compound, or any combination thereof. In some embodiments, the property of the fluid sample comprises aconcentration and / or presence of an analyte. In some embodiments, the property of the fluid sample comprises a concentration and / or presence of a protein, a peptide, an antibody, or a combination thereof. In some embodiments, the analyte may comprise a complement protein. In some embodiments, the analyte may comprise a compound in response to an injection of the medicament. In some embodiments, the analyte may comprise a compound in immune response to an injection of the medicament. In some embodiments, the analyte may comprise a mannose binding lectin. In some embodiments, the analyte may comprise antibodies (e.g., IgM, IgG) or fragment thereof. In some embodiments, the analyte may comprise cytokines (e.g., IL-1, IL-6, IL- 10, TNF- a) or fragment thereof. In some embodiments, the analyte may comprise acute phase proteins (e.g., C-reactive protein, haptoglobin, fibrinogen) or fragment thereof. In some embodiments, the analyte may comprise C3, C3a, C3b, C4, C4a, C4b, C5, C5a, or C5b protein or component or fragment thereof. In some embodiments, the system 600 further comprises one or more controllers to activate the one or more sensors. In some embodiments, a first sensor may be activated to measure a first health or physiological parameter. In some embodiments, a second sensor may be activated to measure a second health or physiological parameter. In some embodiments, the first sensor and the second sensor may be activated at the same time. In some embodiments, the first sensor may be activated prior to the second sensor. In some embodiments, the second sensor may not be activated if the first sensor has provided sufficient information of the subject that the second health or physiological parameter is not needed. In some embodiments, the second sensor may be activated only if the first sensor does not provide sufficient information of the subject that the second health or physiological parameter is needed.

[0054] In some embodiments, the first needle may be the same second needle. In some embodiments, the needle for injection may be configured to draw the body fluid sample. In some embodiments, the first needle may be a separate needle from the second needle. In some embodiments, the body fluid sample may be drawn through a lumen of a needle into the reservoir (e.g., storage device). In some embodiments, the body fluid sample may be brought superficially to the skin surface and be collected. In some embodiments, the body fluid sample may be brough superficially to the skin surface through a needle stick. In some embodiments, the one or more sensors may measure superficially the property of the body fluid sample. In some embodiments, the injection patch may comprise microfluidics for flowing the body fluid sample. In some embodiments, the first needle may continuously draw the body fluid sample. In some embodiments, the first needle may draw the body fluid sample at discrete time points. In some embodiments, the first needle may draw the body fluid sample at discrete time periods. In some embodiments, the first needle may be retained in the body when the first needle is drawingthe body fluid sample. In some embodiments, the first needle may be retracted from the body when the first needle is not drawing the body fluid sample. In some embodiments, the first needle may be retained in the body when the first needle is not drawing the body fluid sample.

[0055] In some embodiments, the system 600 further comprises a non-transitory computer- readable storage media encoded with a computer program including instructions executable by a processor 620 to analyze the measured property to determine the health or physiological parameter. In some embodiments, the health or physiological parameter comprises a disease, an infection, a presence of a bacteria, a presence of a virus, a blood sugar level, a blood alcohol content, or any combination thereof.

[0056] In some embodiments, the system 600 further comprises a communication device 610 configured to transmit the measured property. In some embodiments, the communication device 610 is further configured to transmit the analysis of the measured property. In some embodiments, the communication device 610 comprises a Bluetooth communication device, a cellular communication device, a Wi-Fi communication device, a satellite communication device, or any combination thereof.

[0057] In some embodiments, the injection patch is configured to be secured to the subject for an elongated period of time. In some embodiments, when an injection is complete, the injection patch is configured to be removed from the subject. In some embodiments, the first needle and the second needle are configured to be removed from the subject upon completion of the injection. In some embodiments, the system is configured to collect the fluid sample at various time intervals during the injection of the drug product. In some embodiments, one or more sensors of the injection patch or one or more external sensors or detectors may analyze the fluid sample and determine if additional injection is needed. In some embodiments, when multiple fluid samples are collected, after each collection, the first needle is retracted from the subject and re-inserted for subsequent sample collection. In some embodiments, when multiple fluid samples are collected, after each collection, the first needle may not be retracted from the subject.Methods for Measuring a Health or Physiological Parameter of a Subject

[0058] Provided herein is a method for measuring a health or physiological parameter of a subject. In some embodiments, the method comprises (a) providing the system for measuring a health or physiological parameter of a subject herein and (b) securing the injection patch to the subject. In some embodiments, the method comprises (c) transforming the injection patch into the activated configuration. In some embodiments, the method comprises (d) transforming the injection patch into the drug delivery configuration.

[0059] In some embodiments, step (d) is performed before step (c). In some embodiments, step (d) is performed after step (c). In some embodiments, the method further comprises unlocking the primary or first reservoir, the secondary or second reservoir, or both from the injection patch. In some embodiments, the method further comprises unlocking the primary or first reservoir, the secondary or second reservoir, or both from the injection patch by a key. In some embodiments, the method further comprises removing the primary or first reservoir, the secondary or second reservoir, or both from the injection patch.

[0060] In some embodiments, the method further comprises drawing a fluid sample from the subject, when the injection patch is transformed into the activated configuration. In some embodiments, the method further comprises measuring a property of the fluid sample. In some embodiments, the method further comprises analyzing the measured property to determine the health or physiological parameter. In some embodiments, the method further comprises transmitting the measured property, the health or physiological parameter, or both.

[0061] In some embodiments, the method further comprises injecting or delivering a drug product to the subject, when the injection patch is transformed into the drug delivery configuration.

[0062] Referring to FIG. 7, in some embodiments, the method further comprises shipping (operation 710) the fluid sample in the first system 100, the second system 200, the third system 300, the fourth system 400, the fifth system 500, the primary reservoir 110, the primary reservoir 210, the sample unit 390, the sample slide 310A, the primary reservoir 410, and / or the primary reservoir device 510 to a remote laboratory 720. In some embodiments, the method further comprises analyzing the fluid sample (operation 730). The method may further comprise enclosing the fluid sample in the first system 100, the second system 200, the third system 300, the fourth system 400, the fifth system 500, the primary reservoir 110, the primary reservoir 210, the sample unit 390, the sample slide 310A, the primary reservoir 410, or the primary reservoir device 510 in a container that is sterile, waterproof, air-tight, or any combination thereof. The method may further comprise labeling the first system 100, the second system 200, the third system 300, the fourth system 400, the fifth system 500, the primary reservoir 110, the primary reservoir 210, the sample unit 390, the sample slide 310A, the primary reservoir 410, or the primary reservoir device 510.Computing Systems

[0063] Referring to FIG. 8, a block diagram is shown depicting an exemplary machine that includes a computer system 800 (e.g., a processing or computing system) within which a set of instructions can execute for causing a device to perform or execute any one or more of theaspects and / or methodologies for static code scheduling of the present disclosure. The components in FIG. 8 are examples only and do not limit the scope of use or functionality of any hardware, software, embedded logic component, or a combination of two or more such components implementing particular embodiments.

[0064] Computer system 800 may include one or more processors 801, a memory 803, and a storage 808 that communicate with each other, and with other components, via a bus 840. The bus 840 may also link a display 832, one or more input devices 833 (which may, for example, include a keypad, a keyboard, a mouse, a stylus, etc.), one or more output devices 834, one or more storage devices 835, and various tangible storage media 836. All of these elements may interface directly or via one or more interfaces or adaptors to the bus 840. For instance, the various tangible storage media 836 can interface with the bus 840 via storage medium interface 826. Computer system 800 may have any suitable physical form, including but not limited to one or more integrated circuits (ICs), printed circuit boards (PCBs), mobile handheld devices (such as mobile telephones or PDAs), laptop or notebook computers, distributed computer systems, computing grids, or servers.

[0065] Computer system 800 includes one or more processor(s) 801 (e.g., central processing units (CPUs) or general purpose graphics processing units (GPGPUs)) that carry out functions. Processor(s) 801 optionally contains a cache memory unit 802 for temporary local storage of instructions, data, or computer addresses. Processor(s) 801 are configured to assist in execution of computer readable instructions. Computer system 800 may provide functionality for the components depicted in FIG. 8 as a result of the processor(s) 801 executing non-transitory, processor-executable instructions embodied in one or more tangible computer-readable storage media, such as memory 803, storage 808, storage devices 835, and / or storage medium 836. The computer-readable media may store software that implements particular embodiments, and processor(s) 801 may execute the software. Memory 803 may read the software from one or more other computer-readable media (such as mass storage device(s) 835, 836) or from one or more other sources through a suitable interface, such as network interface 820. The software may cause processor(s) 801 to carry out one or more processes or one or more steps of one or more processes described or illustrated herein. Carrying out such processes or steps may include defining data structures stored in memory 803 and modifying the data structures as directed by the software.

[0066] The memory 803 may include various components (e.g., machine readable media) including, but not limited to, a random access memory component (e.g., RAM 804) (e.g., static RAM (SRAM), dynamic RAM (DRAM), ferroelectric random access memory (FRAM), phase-change random access memory (PRAM), etc.), a read-only memory component (e.g., ROM 805), and any combinations thereof. ROM 805 may act to communicate data and instructions unidirectionally to processor(s) 801, and RAM 804 may act to communicate data and instructions bidirectionally with processor(s) 801. ROM 805 and RAM 804 may include any suitable tangible computer-readable media described below. In one example, a basic input / output system 806 (BIOS), including basic routines that help to transfer information between elements within computer system 800, such as during start-up, may be stored in the memory 803.

[0067] Fixed storage 808 is connected bidirectionally to processor(s) 801, optionally through storage control unit 807. Fixed storage 808 provides additional data storage capacity and may also include any suitable tangible computer-readable media described herein. Storage 808 may be used to store operating system 809, executable(s) 810, data 811, applications 812 (application programs), and the like. Storage 808 can also include an optical disk drive, a solid-state memory device (e.g., flash-based systems), or a combination of any of the above. Information in storage 808 may, in appropriate cases, be incorporated as virtual memory in memory 803.

[0068] In one example, storage device(s) 835 may be removably interfaced with computer system 800 (e.g., via an external port connector (not shown)) via a storage device interface 825. Particularly, storage device(s) 835 and an associated machine-readable medium may provide non-volatile and / or volatile storage of machine-readable instructions, data structures, program modules, and / or other data for the computer system 800. In one example, software may reside, completely or partially, within a machine-readable medium on storage device(s) 835. In another example, software may reside, completely or partially, within processor(s) 801.

[0069] Bus 840 connects a wide variety of subsystems. Herein, reference to a bus may encompass one or more digital signal lines serving a common function, where appropriate. Bus 840 may be any of several types of bus structures including, but not limited to, a memory bus, a memory controller, a peripheral bus, a local bus, and any combinations thereof, using any of a variety of bus architectures. As an example and not by way of limitation, such architectures include an Industry Standard Architecture (ISA) bus, an Enhanced ISA (EISA) bus, a Micro Channel Architecture (MCA) bus, a Video Electronics Standards Association local bus (VLB), a Peripheral Component Interconnect (PCI) bus, a PCI-Express (PCI-X) bus, an Accelerated Graphics Port (AGP) bus, HyperTransport (HTX) bus, serial advanced technology attachment (SATA) bus, and any combinations thereof.

[0070] Computer system 800 may also include an input device 833. In one example, a user of computer system 800 may enter commands and / or other information into computer system 800via input device(s) 833. Examples of an input device(s) 833 include, but are not limited to, an alpha-numeric input device (e.g., a keyboard), a pointing device (e.g., a mouse or touchpad), a touchpad, a touch screen, a multi-touch screen, a joystick, a stylus, a gamepad, an audio input device (e.g., a microphone, a voice response system, etc.), an optical scanner, a video or still image capture device (e.g., a camera), and any combinations thereof. In some embodiments, the input device is a Kinect, Leap Motion, or the like. Input device(s) 833 may be interfaced to bus 840 via any of a variety of input interfaces 823 (e.g., input interface 823) including, but not limited to, serial, parallel, game port, USB, FIREWIRE, THUNDERBOLT, or any combination of the above.

[0071] In particular embodiments, when computer system 800 is connected to network 830, computer system 800 may communicate with other devices, specifically mobile devices and enterprise systems, distributed computing systems, cloud storage systems, cloud computing systems, and the like, connected to network 830. Communications to and from computer system 800 may be sent through network interface 820. For example, network interface 820 may receive incoming communications (such as requests or responses from other devices) in the form of one or more packets (such as Internet Protocol (IP) packets) from network 830, and computer system 800 may store the incoming communications in memory 803 for processing. Computer system 800 may similarly store outgoing communications (such as requests or responses to other devices) in the form of one or more packets in memory 803 and communicated to network 830 from network interface 820. Processor(s) 801 may access these communication packets stored in memory 803 for processing.

[0072] Examples of the network interface 820 include, but are not limited to, a network interface card, a modem, and any combination thereof. Examples of a network 830 or network segment 830 include, but are not limited to, a distributed computing system, a cloud computing system, a wide area network (WAN) (e.g., the Internet, an enterprise network), a local area network (LAN) (e.g., a network associated with an office, a building, a campus or other relatively small geographic space), a telephone network, a direct connection between two computing devices, a peer-to-peer network, and any combinations thereof. A network, such as network 830, may employ a wired and / or a wireless mode of communication. In general, any network topology may be used.

[0073] Information and data can be displayed through a display 832. Examples of a display 832 include, but are not limited to, a cathode ray tube (CRT), a liquid crystal display (LCD), a thin film transistor liquid crystal display (TFT-LCD), an organic liquid crystal display (OLED) such as a passive-matrix OLED (PMOLED) or active-matrix OLED (AMOLED) display, a plasmadisplay, and any combinations thereof. The display 832 can interface to the processor(s) 801, memory 803, and fixed storage 808, as well as other devices, such as input device(s) 833, via the bus 840. The display 832 is linked to the bus 840 via a video interface 822, and transport of data between the display 832 and the bus 840 can be controlled via the graphics control 821. In some embodiments, the display is a video projector. In some embodiments, the display is a headmounted display (HMD) such as a VR headset. In further embodiments, suitable VR headsets include, by way of non-limiting examples, HTC Vive, Oculus Rift, Samsung Gear VR, Microsoft HoloLens, Razer OSVR, FOVE VR, Zeiss VR One, Avegant Glyph, Freefly VR headset, and the like. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0074] In addition to a display 832, computer system 800 may include one or more other peripheral output devices 834 including, but not limited to, an audio speaker, a printer, a storage device, and any combinations thereof. Such peripheral output devices may be connected to the bus 840 via an output interface 824. Examples of an output interface 824 include, but are not limited to, a serial port, a parallel connection, a USB port, a FIREWIRE port, a THUNDERBOLT port, and any combinations thereof.

[0075] In addition or as an alternative, computer system 800 may provide functionality as a result of logic hardwired or otherwise embodied in a circuit, which may operate in place of or together with software to execute one or more processes or one or more steps of one or more processes described or illustrated herein. Reference to software in this disclosure may encompass logic, and reference to logic may encompass software. Moreover, reference to a computer-readable medium may encompass a circuit (such as an IC) storing software for execution, a circuit embodying logic for execution, or both, where appropriate. The present disclosure encompasses any suitable combination of hardware, software, or both.

[0076] Those of skill in the art will appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality.

[0077] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discretegate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0078] The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by one or more processor(s), or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal.Non-transitory computer readable storage medium

[0079] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer readable storage media encoded with a program including instructions executable by the operating system of an optionally networked computing device. In further embodiments, a computer readable storage medium is a tangible component of a computing device. In still further embodiments, a computer readable storage medium is optionally removable from a computing device. In some embodiments, a computer readable storage medium includes, by way of non-limiting examples, CD-ROMs, DVDs, flash memory devices, solid state memory, magnetic disk drives, magnetic tape drives, optical disk drives, distributed computing systems including cloud computing systems and services, and the like. In some cases, the program and instructions are permanently, substantially permanently, semipermanently, or non-transitorily encoded on the media.Computer program

[0080] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program, or use of the same. A computer program includes a sequence of instructions, executable by one or more processor(s) of the computing device’sCPU, written to perform a specified task. Computer readable instructions may be implemented as program modules, such as functions, objects, Application Programming Interfaces (APIs), computing data structures, and the like, that perform particular tasks or implement particular abstract data types. In light of the disclosure provided herein, those of skill in the art will recognize that a computer program may be written in various versions of various languages.

[0081] The functionality of the computer readable instructions may be combined or distributed as desired in various environments. In some embodiments, a computer program comprises one sequence of instructions. In some embodiments, a computer program comprises a plurality of sequences of instructions. In some embodiments, a computer program is provided from one location. In other embodiments, a computer program is provided from a plurality of locations. In various embodiments, a computer program includes one or more software modules. In various embodiments, a computer program includes, in part or in whole, one or more web applications, one or more mobile applications, one or more standalone applications, one or more web browser plug-ins, extensions, add-ins, or add-ons, or combinations thereof.Terms and Definitions

[0082] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0083] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0084] As used herein, the term “about” in some cases refers to an amount that is approximately the stated amount.

[0085] As used herein, the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1%, including increments therein.

[0086] As used herein, the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.

[0087] As used herein, the phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.

[0088] The term “subject,” as used herein, generally refers to a user of a device, system, or method of the present disclosure, or an individual on which a device, system, or method of the present disclosure is being used. The subject may be a patient (e.g., a patient that is being treatedor monitored by a physician or healthcare provider). As an alternative, the subject may not be a patient. The subject may have or be suspected of having a disease or disorder. As an alternative, the subject may be asymptomatic with respect to a disease or disorder. The subject may be a vertebrate, a mammal (e.g., human or animal), a non-human primate, etc. The subject may be an animal, such as a rodent (e.g., rat or mouse), a canine (e.g., dog), a feline (e.g., cat), a bovine, or other animal.

[0089] The term “medicament,” as used herein, generally refers to a substance that is used for treating a health or physiological state or condition of a subject (e.g., medical treatment). The medicament may be a drug or therapeutic agent. The medicament may be a solid, liquid, gas, or combinations thereof. The medicament may be an aerosol, pill, tablet, capsule, pastille, elixir, emulsion, effervescent powder, solution, suspension, tincture, liquid, gel, dry powder, vapor, droplet, ointment, or a combination or variation thereof. A medicament may be used to treat an illness, ailment, or disease, or may be used as a health supplement (e.g., vitamins, minerals, probiotics, etc.).

[0090] Th term “lateral flow strip,” as used herein, generally refers a sample storage device comprising a preservative and / or an anti-coagulant for sample preservation during transport.EXAMPLES

[0091] The following illustrative examples are representative of embodiments of the software applications, devices, systems, and methods described herein and are not meant to be limiting in any way.First System for Measuring a Health or Physiological Parameter of a Subject

[0092] FIGS. 1A-1D show an exemplary first system 100 for measuring a health or physiological parameter of a subject. As shown, in some embodiments, the first system 100 comprises a primary reservoir (or first reservoir, used interchangeably in the present disclosure) 110, a secondary (or second reservoir, used interchangeably in the present disclosure) reservoir 130, and an injection patch 150. In some embodiments, the primary reservoir 110 is configured to store a fluid sample 120 of the subject. In some embodiments, the secondary reservoir 130 is configured to store a drug product 140. In some embodiments, the injection patch 150 comprises an injector 160 comprising a needle 112.

[0093] In a storage configuration of the injection patch 150, as shown in FIG. 1A, a proximal tip of the needle 112 may be within the injection patch 150. In some embodiments, in the storage configuration of the injection patch 150, the primary needle 112 is outside the secondary reservoir 130. The first needle 112 may be retained within a septum. With the first needle beingretained within the septum, the drug product path is kept sterile until the time of use.

[0094] In an activated configuration of the injection patch 150, as shown in FIG. IB, the fluid sample 120 may be drawn from the subject through the needle 112 and into the primary reservoir 110. The needle 112 may be pushed through the septum into the subject. In some embodiments, in an activated configuration of the injection patch 150, the injector 160 draws the fluid sample 120 from the subject. In some embodiments, in the activated configuration of the injection patch 150, the needle 112 is not in fluidic communication with the secondary reservoir 130. In some embodiments, in the activated configuration of the injection patch 150, a proximal tip of the needle 112 extends into the tissue of the subject to collect the fluid sample 120. In some embodiments, in the activated configuration of the injection patch 150, the needle 112 draws the fluid sample 120 through a lumen of the needle.

[0095] In a drug delivery configuration of the injection patch 150, as shown in FIG. 1C, the drug product 140 is injected into the subject. The needle 112 may be in fluidic communication with the second reservoir 130 through a fluid channel 131. In the drug delivery configuration, the needle may be disconnected from the first reservoir 110. The drug product 140 may be injected into the subject from the second reservoir 130 through the fluid channel 131 and the needle 112. In some embodiments, the needle 112 may comprise a side opening, and in the drug delivery configuration, the needle may be in fluidic communication with the fluid channel through the side opening of the needle. The drug product may be flown through the side opening, from the fluid channel to the needle.

[0096] The septum may provide an advantage of sealing the needle tip and the side opening of the needle before and after dispensing. Sealing the needle tip and the side opening at the end of the injection can prevent dripping of the drug product from the injector after end of dispense and / or after it is removed from the skin surface. It can also prevent contaminates from entering the needle prior to being actuated into the skin. The septum may comprise a pierceable membrane that can be made of any suitable material to allow for sealing once the needle has punctured it. The material composition of the septum, or of the pierceable membrane, may comprise silicone, or a blend of different materials including but not limited to bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybudtadiene, EPDM, PTFE, natural rubber and silicone.

[0097] As shown in FIG. ID, in this example, the primary reservoir 110 may be removably coupled to the injector 160. The primary reservoir 110 may decouple from the injector 160 once the drug product 140 may be injected into the subject through the needle 112. The primary reservoir 110 may decouple from the injector 160 by a snapping coupling. The primary reservoir110 may decouple from the injector 160 by a locked snapping coupling. The primary reservoir 110 may decouple from the injector 160 once being unlocked from the injector 160. The primary reservoir 110 and the injector 160 may comprise a locking mechanism. The secondary reservoir 130 may be rigidly coupled to the injector 160. The primary reservoir 110 may comprise a vacutainer. The injection patch 150 may comprise a housing configured to be secured to the subject. The housing of the injection patch 150 may enclose at least a portion of the primary reservoir 110, the secondary reservoir 130, and the injector 160. The system 100 may further comprise a valve fluidically coupled to the needle 112, the primary reservoir 110, and / or the secondary reservoir 130. In some embodiments, as shown, in the activated configuration, the valve fluidically connects the primary reservoir 110 and the needle, wherein in the drug delivery configuration the valve fluidically connects the second reservoir 130 to the needle. In some embodiments, the system 100 may further comprise a first pump (e.g., a vacuum pump) configured to draw the fluid sample from the subject. The first pump may be in fluid communication with the injector. In some embodiments, the system 100 may further comprise a second pump configured to dispense the drug product from the second reservoir to the fluid channel. In the activated configuration, the first pump may be activated while the second pump may be deactivated. In the drug delivery configuration, the second pump may be activated while the first pump may be deactivated. In this example system, the needle 112 is in fluidic communication with the first reservoir in the activated configuration and in fluidic communication with the second reservoir in the drug delivery configuration.

[0098] In some embodiments, the first reservoir may comprise a wicking material or a lateral flow strip.Second System for Measuring a Health or Physiological Parameter of a Subject

[0099] FIGS. 2A-2D show an exemplary second system 200 for measuring a health or physiological parameter of a subject. As shown, in some embodiments, the second system 200 comprises a primary reservoir 210, a secondary reservoir 230, and an injection patch 250. In some embodiments, the primary reservoir 210 is configured to store a fluid sample 120 of the subject. In some embodiments, the secondary reservoir 230 is configured to store a drug product 140. In some embodiments, the injection patch 250 comprises an injector 260 comprising a primary needle (or first needle, as used interchangeably in the present disclosure) 212 configured to draw a fluid sample from the subject. In some embodiments, the injection patch 250 comprises a second needle (or secondary needle, as used interchangeably in the present disclosure) 232 to dispense a drug product from the second reservoir 230 to the subject. The second needle is in fluidic communication with the second reservoir 230 through a fluid channel231. In some embodiments, the second needle 232 may comprise a side opening, and in the drug delivery configuration, the second needle may be in fluidic communication with the fluid channel through the side opening of the second needle. The drug product may be flown through the side opening, from the fluid channel to the second needle.

[0100] In a storage configuration of the injection patch 250, as shown in FIG. 2A, a proximal tip of the primary needle 212 and a proximal tip of the second needle 232 may be within the injection patch 250. The injection patch may comprise a first septum that covers the proximal tip of the first needle. The injection patch may comprise a second septum that covers the proximal tip of the second needle. In an activated configuration of the injection patch 250, as shown in FIG. 2B, the fluid sample 120 may be drawn from the subject through the primary needle 212 and into the primary reservoir 210. In some embodiments, in the activated configuration of the injection patch250, the injector 260 draws the fluid sample 120 into the primary reservoir 210. In some embodiments, in the activated configuration of the injection patch 250, a proximal tip of the primary needle 212 extends into the tissue of the subject to collect the fluid sample 120. In some embodiments, in the activated configuration of the injection patch 250, the needle 212 draws the fluid sample 120 through a lumen of the needle. In a drug delivery configuration of the injection patch 250, the drug product 140 is injected into the subject from the secondary reservoir 230. The drug product 140 may be injected into the subject by the injector 260 through the second needle 232. In the activated configuration of the injection patch 250, a proximal tip of the primary needle 212 may extend into the tissue of the subject to collect the fluid sample 120. As the sample collection and drug delivery can be performed through separate needles, the sample collection and drug delivery can be independent from each other. In some cases, the sample collection can be performed prior to, concurrently with, or subsequent to the drug delivery.

[0101] As shown in FIGS. 2C-2D, the primary reservoir 210 may be removably coupled to the injector 260. The primary reservoir 210 may decouple from the injector 260 once the fluid sample is collected through the primary needle 212. The primary reservoir 210 may decouple from the injector 260 by a threaded coupling. The primary reservoir 210 may decouple from the injector 260 by a locked threaded coupling. The primary reservoir 210 may decouple from the injector 260 once being unlocked from the injector 260. The primary reservoir 210 and the injector 260 may comprise a locking mechanism. FIG. 2D shows that the first reservoir is removed from the injector 260.

[0102] The secondary reservoir 230 may be rigidly coupled to the injector 260. The primary reservoir 210 may comprise a vacutainer. The injection patch 250 may comprise a housingconfigured to be secured to the subject. The housing of the injection patch 250 may enclose at least a portion of the primary reservoir 210, the secondary reservoir 230, the first needle 212, the second needle 232, and the injector 260. In some cases, the first reservoir and / or the second reservoir may not be enclosed in the housing. The system 200 for measuring a health or physiological parameter of a subject may further comprise one or more valves fluidically coupled to the primary needle 212, the secondary needle 232, the primary reservoir 210, the secondary reservoir 230, or any combination thereof. In some embodiments, as shown, in a first configuration, a valve fluidically connects the primary reservoir 210 and the primary needle, and in a second configuration an additional valve fluidically connects the secondary reservoir 230 to the second needle. In some embodiments, the system 200 may further comprise a first pump (e.g., a vacuum pump) configured to draw the fluid sample from the subject. The first pump may be in fluid communication with the first needle and first reservoir. In some embodiments, the system 200 may further comprise a second pump configured to dispense the drug product from the second reservoir to the fluid channel. In the activated configuration, the first pump may be activated while the second pump may be deactivated. In the drug delivery configuration, the second pump may be activated while the first pump may be deactivated. In some cases, the first pump and the second pump may be activated to collect the fluid sample and deliver the drug product.Third System for Measuring a Health or Physiological Parameter of a Subject

[0103] FIGS. 3A-3F show an exemplary third system 300 for measuring a health or physiological parameter of a subject. As shown, in some embodiments, the system 300 comprises a primary reservoir 310, a secondary reservoir 330, and an injection patch 350. In some embodiments, the primary reservoir 310 is configured to store a fluid sample 120 of the subject. In some embodiments, the secondary reservoir 330 is configured to store a drug product 140. In some embodiments, the injection patch 350 comprises an injector 360 comprising a primary needle 312. In some embodiments, the injection patch 350 comprises a second needle 332.

[0104] In a storage configuration of the injection patch 350, as shown in FIG. 3A, a proximal tip of the primary needle 312 and a proximal tip of the second needle 332 may be within the injection patch 350. The second needle is in fluidic communication with the second reservoir 330 through a fluid channel 331. In some embodiments, the second needle 332 may comprise a side opening, and in the drug delivery configuration, the second needle may be in fluidic communication with the fluid channel through the side opening of the second needle. The drug product may be flown through the side opening, from the fluid channel to the second needle.

[0105] In a drug delivery configuration of the injection patch 350, the drug product 140 is injected into the subject from the secondary reservoir 330. The drug product 140 may be injected into the subject by the injector 360. In an activated configuration of the injection patch 350, as shown in FIG. 3B, the first needle 312 may be inserted into the subject to draw a fluid sample. In some embodiments, in the activated configuration of the injection patch 350, the needle 312 draws the fluid sample 120 through a lumen of the needle. As shown in FIG. 3C, the first needle is retracted from the subject and the proximal tip (or a side opening) of the first needle is brought in fluid communication with the first reservoir 310. In some embodiments, the first reservoir may comprise a wicking material or a lateral flow strip such that the fluid sample can be directed to the first reservoir. In some embodiments, the first needle does not comprise a lumen. In some embodiments, the first needle is a needle stick and upon contact with the wicking material or lateral flow strip, the fluid sample may be collected by the wicking material or lateral flow strip. In some embodiments, the fluid sample may be collected by the wicking material or lateral flow strip through a lumen of the first needle. In some embodiments, the fluid sample may be directed to the first reservoir via a lateral flow. As shown in FIG 3D, the fluid sample 120 is drawn from the subject into the primary reservoir 310. In some embodiments, the wicking material or a lateral flow strip draws the fluid sample 120 from the subject. In some embodiments, the first reservoir may comprise a sample slide. In some embodiments, the sample slide may collect the fluid sample through a lumen of the first needle or the needle stick. In some embodiments, the first reservoir may be removed after a fluid sample is collected. In some embodiments, a new first reservoir may be inserted to collect one or more fluid samples.

[0106] The primary reservoir 310 and the secondary reservoir 330 may be rigidly coupled to the injector 360. The injection patch 350 may comprise a housing wherein the housing of the injection patch 350 may be configured to be secured to the subject. The housing of the injection patch350 may enclose at least a portion of the primary reservoir 310, the secondary reservoir 330, and the injector 360. In the activated configuration of the injection patch 350, a proximal tip of the primary needle 312 may extend into the tissue of the subject to collect the fluid sample 120.

[0107] As shown in FIG. 3E, the primary reservoir 310 may decouple from the injection patch 350 by a sliding coupling. The primary reservoir 310 may comprise a sample slide 310A. As shown in FIG. 3F, the primary reservoir 310 and the first needle may be removably coupled to the injection patch 350. The primary reservoir 310 and the first needle may decouple from the injection patch 350 after the fluid sample is drawn to the first reservoir through the first needle 312. The primary reservoir 310 and the first needle 312 may decouple from the injection patch350 as a sample unit 390. In some embodiments, the second reservoir may be decoupled from the injector 360.Fourth System for Measuring a Health or Physiological Parameter of a Subject

[0108] FIGS. 4A-4E show an exemplary fourth system 400 for measuring a health or physiological parameter of a subject. As shown, in some embodiments, the system 400 comprises a primary reservoir 410 and an injection patch 450. In some embodiments, the primary reservoir 410 is configured to store a fluid sample 120 of the subject. In some embodiments, the injection patch 450 comprises a second reservoir 430 configured to store a drug product 140. In some embodiments, the injection patch 450 comprises an injector 460. In some embodiments, the injection patch 450 comprises a first needle 412. In some embodiments, the injector 450 comprises a second needle 432. In some embodiments, the injection patch 450 comprises an injector 460 comprising the second needle 432. In a storage configuration of the injection patch 450, as shown in FIG. 4A, a proximal tip of the first needle 412 and a proximal tip of the second needle 432 may be within the injection patch 450. The second needle is in fluidic communication with the second reservoir 430 through a fluid channel 431. In some embodiments, the second needle 432 may comprise a side opening, and in the drug delivery configuration, the second needle may be in fluidic communication with the fluid channel through the side opening of the second needle. The drug product may be flown through the side opening, from the fluid channel to the second needle.

[0109] The secondary or second reservoir 430 may be in fluidic communication with the second needle 432, wherein in the drug delivery configuration of the injector 450, the drug product 140 may be injected into the subject through the secondary needle. As shown, the injection patch 450 is configured to be secured to the primary reservoir 410, wherein the primary reservoir 410 is configured to be secured to the subject. The first needle may be actuated by a same controller of the second needle. In some embodiments, the controller may actuate the first needle to advance into the subject to draw a fluid sample. In some embodiments, the controller may actuate the second needle to advance into the subject to deliver a drug product. In some embodiments, the controller may actuate the first needle and the second needle at the same time. In some embodiments, fluid sample collection is performed prior to the drug delivery. In some embodiments, fluid sample collection is performed subsequent to the drug delivery. In some embodiments, fluid sample collection is performed concurrently with the drug delivery.

[0110] As shown in FIG. 4B, the drug product 140 is injected into the subject from the secondary reservoir 430, and a fluid sample is drawn from the subject to the first reservoir. The drug product 140 may be injected into the subject by the injector 460. As shown in FIG. 4C, thefluid sample 120 is emitted from the first needle 412 to the first reservoir, e.g., through a side opening of the first needle. In the activated configuration of the injection patch 450, at least a portion of the primary needle 412 may extend into or through the primary reservoir 410. The first needle may have an angle relative to the second needle, from about 10 degrees to about 80 degrees.[OHl] As shown in FIG. 4D, the primary reservoir 410 may be removably coupled to the injection patch 450. The primary reservoir 410 may decouple from the injection patch 450 by a locked coupling. The primary reservoir 410 may decouple from the injection patch 450 once being unlocked from the injection patch 450. The primary reservoir 410 and the injection patch 450 may comprise a locking mechanism. The secondary reservoir 430 may be rigidly coupled to the injection patch 450. The primary reservoir 410 may comprise a wi eking material or a lateral flow strip. In some embodiments, the wicking material or a lateral flow strip draws the fluid sample 120 from the subject. FIG. 4E shows a top view of the first reservoir 410 containing the collected fluid sample 120. The hole 413 is configured to be penetrated by the first needle 412.

[0112] The injection patch 450 may comprise a housing, wherein the primary reservoir 410 removably couples to the housing. The housing of the injection patch 450 may be configured to be secured to the subject. The housing of the injection patch 450 may enclose at least a portion of the secondary reservoir 430, the first needle, and the injector 460. The primary reservoir 410 may be rotatably and removably coupled to the injection patch 450. The housing of the injection patch 450 may further comprise a bearing, a shaft, a ratchet, or any combination thereof.Fifth System for Measuring a Health or Physiological Parameter of a Subject

[0113] FIGS. 5A-5D show an exemplary fifth system 500 for measuring a health or physiological parameter of a subject. Further, as shown, in some embodiments, the system 500 comprises a plurality of primary reservoirs 511, a first needle 512, a secondary reservoir 530, and an injection patch 550. In some embodiments, the injection patch 550 comprises an injector 560 comprising a second needle 532.

[0114] As shown in FIG. 5A, in an activated configuration, the fluid sample 120 is drawn from the subject into one of the primary reservoirs 511. At least a portion of the plurality of the primary reservoirs 511 may be formed in a primary reservoir device 510. As shown, the injection patch 550 is configured to removably to the primary reservoir device 510, wherein the primary reservoir device 510 is configured to be secured to the subject. The first reservoir device may comprise at least one, at least 2, at least 3, at least 4, at least 5, at least 6, at least 8, at least 10, or more first reservoirs. In this example, the primary reservoir device 510 comprises eight primary reservoirs 511. In some embodiments, each of the plurality of the primary reservoirs511 is configured to store a portion of the fluid sample 120 of the subject. The primary reservoir device 510 may decouple from the injection patch 550 by a locked coupling. The primary reservoir device 510 may decouple from injection patch 550 once unlocked from the injection patch 550. The primary reservoir device 510 and the injection patch550 may comprise a locking mechanism. One or more of the plurality of primary reservoirs 511 may comprise a wicking material or a lateral flow strip. As shown in FIGS. 5A and 5B, in an activated configuration, the fluid sample 120 is drawn from the subject into one of the primary reservoirs 511.

[0115] As shown in FIG. 5C, the primary reservoir device 510 may be removably coupled to the injection patch 550. The primary reservoir device 510 may be rotatably coupled to the injection patch 550. As shown in FIGS. 5C and 5D, once one of the plurality of primary reservoirs 511 is filled with the fluid sample 120, the primary reservoir device 510 may be rotated with respect to the injection patch 550 such that another reservoir of the plurality of primary reservoirs 511 is configured to be filled with the fluid sample 120. FIG. 5C shows a primary reservoir device 510 with five primary reservoirs filled with the fluid sample 120. The primary reservoir device 510 may rotate with respect to the injection patch 550 in a clockwise direction. The primary reservoir device 510 may rotate with respect to the injection patch 550 in a counterclockwise direction. The injection patch 550 may further comprise a bearing, a shaft, a ratchet, or any combination thereof coupling the primary reservoir device 510 to the injection patch 550, to enable the primary reservoir device 510 to rotate with respect to the injection patch 550.

[0116] In some embodiments, the secondary reservoir 530 is configured to store a drug product 140. The injection patch 550 may comprise a housing wherein the primary reservoir device 510 removably couples to the housing. The housing of the injection patch 550 may be configured to be secured to the subject. The housing of the injection patch 550 may enclose at least a portion of the secondary reservoir 530 and the injector 560. The injection patch 550 may be configured to be secured to the primary reservoir device 510, wherein the primary reservoir device 510 may be configured to be secured to the subject. In the activated configuration of the injection patch 550, at least a portion of the primary needle 512 may extend into or through the primary reservoir device 510. In the activated configuration of the injection patch 550, a proximal tip of the primary needle 512 may extend into the tissue of the subject to collect the fluid sample 120.

[0117] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that variousalternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A system for measuring a health or physiological parameter of a subject, comprising:(a) a first reservoir configured to store a fluid sample of the subject;(b) a second reservoir configured to store a drug product; and(c) an injection patch configured to be secured to the subject, the injection patch comprising an injector comprising a first needle, wherein:(i) in a storage configuration of the patch, a proximal tip of the first needle is within the injection patch,(ii) in an activated configuration of the injection patch, the fluid sample is drawn from the subject into the first reservoir; and(iii) in a drug delivery configuration of the injection patch, the drug product is injected into the subject.

2. The system of claim 1, wherein the first reservoir, the second reservoir, or both, are removably coupled to the injector, the injection patch, or both.

3. The system of claim 2, wherein the first reservoir, the second reservoir, or both, decouple from the injector, the injection patch, or both once the drug product is injected into the subject through the first needle.

4. The system of claim 2 or 3, wherein the first reservoir, the second reservoir, or both, decouple from the injector, the injection patch, or both by a threaded coupling, a sliding coupling, a snapping coupling, a locking coupling, or any combination thereof.

5. The system of any one of claims 2-4, wherein the first reservoir, the second reservoir, or both, decouple from the injector, the injection patch, or both once being unlocked from the injection patch, the injector, or both.

6. The system of claim 5, wherein the first reservoir, the second reservoir, or both and the injection patch, the injector comprise a locking mechanism.

7. The system of any one of claims 1-6, wherein the first reservoir, the second reservoir, or both, are rigidly coupled to the injector, the injection patch, or both.

8. The system of any one of claims 1-7, wherein the first reservoir, the second reservoir, or both, comprises a wicking material, a lateral flow strip, a sample slide, a vacutainer, or any combination thereof.

9. The system of any one of claims 1-8, wherein the injection patch comprises a housing, wherein the first reservoir, the second reservoir, or both, are removably coupled to the housing.

10. The system of claim 9, wherein the housing of the injection patch is configured to be secured to the subject.

11. The system of claim 9 or 10, wherein the housing of the injection patch encloses at least a portion of the first reservoir, at least a portion of the second reservoir, the injector, or any combination thereof.

12. The system of any one of claims 1-11, comprising a plurality of the first reservoirs, wherein each of the plurality of the primary reservoirs is configured to store a portion of the fluid sample of the subject.

13. The system of claim 12, wherein at least a portion of the plurality of the first reservoirs are formed in a first reservoir device.

14. The system of claim 13, wherein the first reservoir device is rotatably and removably coupled to the injection patch.

15. The system of claim 14, further comprising a bearing, a shaft, a ratchet, or any combination thereof coupling the first reservoir device to the injection patch.

16. The system of any one of claims 1-15, wherein the injection patch is configured to be secured to the first reservoir, wherein the first reservoir is configured to be secured to the subject.

17. The system of any one of claims 1-16, wherein in the activated configuration of the injection patch, at least a portion of the first needle extends into or through the second reservoir.

18. The system of any one of claims 1-17, wherein in the activated configuration of the injection patch a proximal tip of the first needle extends into the tissue of the subject to collect the fluid sample.

19. The system of any one of claims 1-18, further comprising a sensor measuring a property of the fluid sample, a presence of the fluid sample, or both.

20. The system of claim 19, further comprising a non-transitory computer-readable storage media encoded with a computer program including instructions executable by a processor to analyze the measured property to determine the health or physiological parameter.

21. The system of claim 19 or 20, further comprising a communication device transmitting the measured property.

22. The system of claim 19 or 20, further comprising a communication device transmitting the health or physiological parameter.

23. The system of any one of claims 1-22, further comprising a valve fluidically coupled to the first needle, the first reservoir, the second reservoir, or any combination thereof.

24. The system of any one of claims 1-23, wherein the second reservoir comprises a second needle, wherein in the drug delivery configuration of the injection patch, the drug product is injected into the subject through the second needle.

25. A method for measuring a health or physiological parameter of a subject, the method comprising:(a) providing the system of any one of claims 1-24;(b) securing the injection patch to the subject;(c) transforming the injection patch into the activated configuration; and(d) transforming the injection patch into the drug delivery configuration.

26. The method of claim 25, wherein step (d) is performed before step (c).

27. The method of claim 25, wherein step (d) is performed after step (c).

28. The method of any one of claims 25-27, further comprising:(e) unlocking the first reservoir, the second reservoir, or both from the injection patch.

29. The method of any one of claims 25-28, further comprising:(f) removing the first reservoir, the second reservoir, or both from the injection patch.

30. The method of any one of claims 25-29, further comprising measuring a property of the fluid sample.

31. The method of any one of claims 25-30, further comprising analyzing the measured property to determine the health or physiological parameter.

32. The method of claim 31, further comprising transmitting the measured property, the health or physiological parameter, or both.

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