Container, apparatus, process and system for tracking and managing items with cyclic chain of regulations

Abstract

The methods disclosed herein may provide a closed loop physical supply chain using precision containers. An example container includes an outer shell and an inner chamber fitted in the outer shell. The interior chamber includes a first compartment for removably containing a product and a second compartment having an environmental control mechanism. A closure layer securable to or integrated with the interior chamber includes a controller and a communication interface for communicating with a device external to the precision container. A plurality of sensors monitoring the first compartment send signals to the controller of the closed layer. A locking mechanism, when engaged, secures the housing to the interior chamber and, when disengaged, unlocks the housing from the interior chamber, thereby enabling access to the first compartment and the product in the first compartment. The container may track its condition and position and need to be verified prior to disengagement of the locking mechanism.

Description

[0001] Citation of Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 294,758, filed on December 29, 2021, the entire contents of which are incorporated herein by reference. Background Art

[0003] Cell and gene therapy (CGT) is a new area of ​​medicine. It is a scientific method defined as the extraction of cells, proteins or genetic material from a patient or donor, modification of them, and then reinjection of the modified material back into the patient. CAR-T therapy holds great promise as an immunotherapy that uses the patient's T cells to fight cancer, providing patients with personalized treatment in addition to traditional chemotherapy, surgery and radiation. The patient's T cells, which are the cells responsible for the immune system's response, are isolated from the patient's blood through plasmapheresis and modified in the laboratory by the addition of synthetic receptors (called chimeric antigen receptors, or CARs). The combined CAR-T cells are then expanded to hundreds of millions and ultimately returned to the patient, where they multiply further as they recognize and kill cancer cells in the patient's body.

[0004] For example, plasmapheresis separates and extracts white blood cells from a patient's blood in a 2- to 3-hour process. The white blood cells are then sent to a laboratory for testing and clinical review as required by the CAR-T. Patient specimens (i.e., bags of white blood cells) should be properly managed according to the guidelines for each treatment, and most require cryopreservation. Preparation, validation, packaging, ordering, shipping and receiving, scheduling, and testing are managed by hospital administrators and clinical staff. The manufacturing process (i.e., adding CAR and culturing cells) is managed by pharmaceutical companies, specific companies based on the requirements of the treatment.

[0005] Clinicians are burdened with managing a myriad of processes that start with drawing blood from a patient and continue through transfusion back into the patient. Processes span pharmaceutical companies, blood banks, laboratories, and medical centers, each with their own requirements and processes. Coordination of the continuum of care requires nearly every organizational level and functional role in the hospital environment. Current management practices involve transcribing collected paper data into spreadsheets, emails, and disparate software solutions.

[0006] By 2025, the FDA anticipates “10 to 20 cell and gene therapy products will be approved annually” (FDA Active Product Development Guidance (January 2019)). CAR-T cycle times (extraction to infusion) can take weeks to months, depending on market conditions, leaving patients and clinical stakeholders uncertain about treatment status. As production increases and new therapies come to market, the risk of poor quality, fraud, and rising costs may follow. These personalized treatments are expensive, with many CAR-T therapies costing anywhere from $300,000 to $500,000 per round of treatment. Insurance claims are heavily scrutinized, and reimbursement is often disputed, increasing financial risk to hospital cash flows. Many of the issues stem from a lack of transparency. Tracking status and planning for downstream dependencies requires detailed coordination between hospital administration and clinical operations. Summary of the invention

[0007] The first aspect relates to a precision container. In various embodiments, the precision container may include an outer shell and an inner chamber assembled in the outer shell, the inner chamber including a plurality of compartments. The plurality of compartments may include a first compartment for removably accommodating a product. The plurality of compartments may include a second compartment, the second compartment including one or more environmental control mechanisms. The precision container may include a closed layer. The closed layer may include a controller and one or more communication interfaces, the one or more communication interfaces being used to communicate with one or more devices outside the precision container. The precision container may include a plurality of sensors for monitoring the first compartment. The plurality of sensors may be coupled to the controller of the closed layer. The precision container may include a locking mechanism. The locking mechanism may be engaged to secure the outer shell to the inner chamber. The locking mechanism may be disengaged to unlock the outer shell from the inner chamber, thereby enabling access to the first compartment. The locking mechanism may be engaged or disengaged according to instructions from the controller.

[0008] In various embodiments, the one or more environmental control mechanisms of the second compartment may include a cooling mechanism. In various embodiments, the cooling mechanism may include a cooling mechanism that adjusts the refrigeration according to a signal from the controller. In various embodiments, the cooling mechanism may include a cold bag. In various embodiments, the enclosed layer may be fixed to the inner chamber. In various embodiments, the enclosed layer may include one or more openings for allowing wiring from multiple sensors to enter the enclosed layer. In various embodiments, the precision container may also include an output device. In various embodiments, the controller generates an audiovisual indicator for indicating a fault of the precision container when a measurement value at or above a threshold is detected. In various embodiments, the audiovisual indicator may be an audible alarm and / or a visible light. In various embodiments, the fault may indicate that the temperature is too high, the humidity level is too high or too low, the force experienced is too high (indicating, for example, a severe collision or fall) and / or the location of the container is unauthorized.

[0009] In various embodiments, the second compartment may be sealed so that access to the second compartment is restricted when the locking mechanism is disengaged. In various embodiments, the plurality of sensors may include a biometric sensor for authenticating the user before the locking mechanism is disengaged. In various embodiments, the enclosed layer may include a memory device. In various embodiments, the controller may record data each time an attempt is made to approach the precision container. In various embodiments, the plurality of sensors may include an accelerometer for detecting the force to which the precision container is subjected. In various embodiments, the plurality of sensors may include a humidity sensor. In various embodiments, the plurality of sensors may include a temperature sensor. In various embodiments, the precision container may include a positioning device. In various embodiments, the positioning device may periodically detect the position of the precision container. In various embodiments, the positioning device may transmit the position to the system via one or more communication interfaces. In various embodiments, the positioning device may be or may include a global positioning system (GPS) device. In various embodiments, the precision device may include an accelerometer. In various embodiments, each time a force exceeding a threshold is detected using an accelerometer, the controller may use the positioning device to detect the position of the precision container.

[0010] Another aspect relates to a method of using a precision container. In various embodiments, the precision container includes: an outer shell and an inner chamber assembled in the outer shell, the inner chamber including a plurality of compartments, the plurality of compartments including a first compartment and a second compartment, the second compartment including one or more environmental control mechanisms; a closed layer, which includes a controller and one or more communication interfaces, the one or more communication interfaces are used to communicate with one or more devices outside the precision container; a plurality of sensors for monitoring the first compartment, the plurality of sensors coupled to the controller of the closed layer; and a locking mechanism that engages to secure the outer shell to the inner chamber and disengages to release the outer shell from the inner chamber. The method may include placing a product into the first compartment at a first location. The method may include assembling the outer shell over the inner chamber. The method may include engaging the locking mechanism to secure the outer shell to the inner chamber. The method may include providing a precision container for shipment to a second location.

[0011] In various embodiments, engaging the locking mechanism includes using an application executed on a user device that communicates with the precision container. In various embodiments, the product is a sample. In various embodiments, the method may include collecting the sample from a subject. In various embodiments, the product is a first product. In various embodiments, the precision container is a first precision container. In various embodiments, the method includes removing a second product from the first precision container or the second precision container. In various embodiments, the method includes administering the second product to the subject. In various embodiments, the second product includes a modification or derivative of the first product placed into a first compartment of the first precision container.

[0012] The foregoing general description and the following description of the drawings and detailed description are exemplary and illustrative, and are intended to provide further explanation of the invention claimed. Other objects, advantages and novel features will be apparent to those skilled in the art from the following brief description of the drawings and detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The drawings are not intended to be drawn to scale. Like reference numbers and names in the various drawings represent like elements. For clarity, not every component may be labeled in every drawing. In the drawings:

[0014] Figure 1 is a block diagram illustrating the general architecture of a computer system that may be employed to implement elements of the systems and methods described and illustrated herein, according to various potential implementations.

[0015] Figure 2A is a diagram illustrating a process according to various potential embodiments in which a product is obtained from a source (used interchangeably with an "origin" or starting point), shipped to a location (e.g., a transit or intermediate location between the source and a destination) for modification or other processing, and shipped back to a destination that is the same source to receive it.

[0016] Figure 2B is a diagram illustrating a potential chain of custody involving a source, a destination, and one or more transit locations according to various potential implementations.

[0017] Figure 3 is a diagram showing an exemplary container (and various sensors) in which products and modified products can be transported along a Figure 2A or Figure 2B The chain is transported and monitored.

[0018] Figure 4 Depicted are housings for precision containers according to various potential embodiments.

[0019] Figure 5A An interior chamber of a precision container is depicted from a first perspective according to various potential embodiments.

[0020] Figure 5B The interior chamber of a precision container according to various potential embodiments is depicted from a second perspective.

[0021] Figure 6 Possible dimensions for exemplary housings according to various potential implementations are depicted.

[0022] Figure 7Possible dimensions for exemplary interior chambers are depicted according to various potential embodiments.

[0023] Fig. 8A Depicted are elevation views of exemplary interior chambers and exemplary interior chamber containment layers according to various potential embodiments.

[0024] Figure 8B Depicts the potential implementations Fig. 8A A top view of an exemplary interior chamber and features of the interior of the containment layer. DETAILED DESCRIPTION

[0025] Various embodiments of the present disclosure relate to containers, devices, processes and systems for tracking and managing items, products and / or packages, which may but need not have a circular chain of custody (e.g., a package with the same origin or source as the destination of the package). Certain products or items may be both inputs and outputs of circular exchange of custody between various organizations and individuals. Each step may require the exchange of information and / or actual actions to manage "custody changes", "identity chains" and / or "form changes". Various embodiments provide a closed-loop physical supply chain with a mirrored digital supply chain. Although the present disclosure provides specific examples related to pharmaceuticals in the illustrative embodiments of the technology, the technology is not limited to such use cases and may be equally applicable in other situations where any item, product or package needs to be handled and transported more safely and controllably, particularly in situations where the item, product or package has a transit point ("stop") for moving from a starting point to a destination point.

[0026] The various concepts introduced above and discussed in greater detail below can be implemented in any of numerous ways, as the concepts described are not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.

[0027] Figure 1 The general architecture of an illustrative computer device / computer system 100 is shown, one or more of which may be employed to implement each of the computer systems discussed herein according to some embodiments, as well as client devices 135A and 135B. Computer device / computer system 100 may be used to provide information via network 130 for display. Figure 1 The computer device / computer system 100 includes one or more processors 120, which are communicatively coupled to one or more memories 125, one or more communication interfaces 105, one or more output devices 110 (e.g., one or more display units, speakers, light sources, tactile feedback devices, etc.) and one or more input devices 115 (e.g., microphones, touch screens and / or sensors).

[0028] exist Figure 1 In the computer device / computer system 100, one or more memories 125 may include any computer-readable storage medium and may store computer instructions (such as processor-executable instructions for implementing the various functions described herein for the corresponding system and any data related to the various functions generated thereby or received via a communication interface or input device (if present)). The memory 125 may include one or more databases. Figure 1 The processor 120 shown in FIG. 1 may be used to execute instructions stored in one or more memories 125 , and in doing so, may also read from or write to the memories various information processed and / or generated according to the execution of the instructions.

[0029] Figure 1 The processor 120 of the computer device or computer system 100 shown in the figure may also be communicatively coupled to the communication interface 105 or control the communication interface to send or receive various information (data, control signals, executable code or other instructions, etc.) according to the execution of instructions. For example, the communication interface 105 may be coupled to a wired or wireless network, a bus or other communication tool, and thus may allow the computer device or computer system 100 to send information to or receive information from other devices (e.g., other computer systems). The communication interface 105 may employ one or more communication protocols, such as "Wi-Fi", "Bluetooth", "Radio Frequency Identification (RFID)", Near Field Communication (NFC), cellular communication (e.g., 3G, 4G and / or 5G), etc. Although in Figure 1 Although not explicitly shown in the system of FIG. 1 , one or more communication interfaces 105 facilitate the flow of information between components of the computer device or computer system 100. In some embodiments, the communication interface 105 can be configured (e.g., via various hardware components or software components) to provide a website as an access portal to at least some aspects of the computer device or computer system 100. Examples of the communication interface 105 may include a user interface (e.g., a web page) through which a user can communicate with the computer device or computer system 100.

[0030] For example, you can provide Figure 1The output device 110 of the computer device or computer system 100 shown in the figure is used to allow viewing or otherwise perceiving various information in conjunction with the execution of instructions. Exemplary output devices include display screens (e.g., touch screen displays), speakers, light sources, tactile devices, and the like. For example, an input device 115 may be provided to allow a user to make manual adjustments, make selections, input data, or interact with the processor in any of a variety of ways during the execution of instructions. Exemplary input devices include cameras, light sensors, touch interfaces (e.g., touch screen displays), microphones, computer mice, keyboards, motion sensors, biometric sensors (e.g., fingerprint readers, facial detection devices, etc.), and the like. Additional information related to a general computer system architecture that can be used for the various systems discussed herein is further provided herein.

[0031] The client devices 135A and 135B may be or include any combination of user computing devices (e.g., smartphones, tablet computers, laptop computers, desktop computers, Internet of Things (IoT) devices, or other smart devices), smart bags, smart containers, global positioning system (GPS) devices, handheld scanners, location detectors, etc. For example, the containers disclosed herein may be considered client devices. The client device 135A includes: input / output (I / O) devices 140A, such as a microphone, camera, touch screen; a communication interface 145A that enables communication over various networks (e.g., the Internet) and using various communication protocols (e.g., "Wi-Fi," "Bluetooth," "cellular," etc.); sensors 150A, such as a position and orientation sensor (e.g., a GPS device that detects GPS signals that identify latitude and longitude coordinates associated with the location of the client device, an accelerometer, a gyroscope, etc.), an environmental sensor (used interchangeably with "environmental sensor") that can measure or detect environmental conditions inside or outside the client device 135A (such as temperature, humidity, pressure, etc.), a biometric sensor (e.g., a fingerprint scanner, a retinal scanner, etc.), a chemical sensor that detects, for example, certain molecules; and / or a vibration sensor (e.g., a 155A); firmware and applications (such as client software applications) 155A, providing various functions (e.g., hardware control, user interface, etc.) with respect to other components of the client device 135A; environmental controls 160A, such as mechanisms for maintaining conditions of the device, such as temperature controls (e.g., heating and / or cooling mechanisms), humidity controls, physical stability controls (e.g., shock absorption), sterilization controls (e.g., emitting ultraviolet or other wavelengths of light to inhibit or otherwise control microbial growth in different parts of a container or for other purposes), etc.; and security controls 165A, such as locking and unlocking mechanisms that can be enabled or disabled via one or more of the other components of the client device 135 (e.g., I / O devices 140A, communication interface 145A, biometric sensor 150A, and / or client application 155A). In some embodiments, a security mechanism can be triggered based on a failure of an environmental control. Although not shown, client device 135B may be equipped identically or similarly to client device 135, may include a subset of the components of client device 135A, or may include one or more of the same or similar components as client device 135A and / or one or more of the different components than client device 135A.

[0032] In various embodiments, client device 135A (e.g., a precision container as discussed herein) includes controller 170A that is capable of directly or indirectly sending data to and / or receiving data from other components of client device 135A. For example, in various embodiments, controller 170A may receive data (such as input) from or via I / O device 140A, status information or other data from or via communication interface 145A, measurements or readings from or via sensor 150A, and acquisition attempts from or via security control 165A. In various embodiments, controller 170A may send data (e.g., commands or other instructions for actions to be taken) to I / O device 140A (e.g., messages or information to be conveyed to a user), to communication interface 145A (e.g., signals to be transmitted to other systems or devices), to sensor 150A (e.g., commands to start, change, or stop detecting various parameters, such as to start reading biometric data), to environmental control 160A (e.g., to engage, change, or disengage various components to change various parameters of internal or external conditions based on various inputs, such as data from sensor 150A), and / or to security control 165A (e.g., to engage or disengage a locking mechanism based on various inputs, such as data from sensor 150A).

[0033] The controller 170A may include one or more processors. In various embodiments, the controller 170A may include one or more memory devices (e.g., volatile or non-volatile memory devices) that store computer instructions, such as processor executable instructions for implementing the various functions described herein for the corresponding device 135A and any data related to the various functions generated thereby or received via the communication interface 145A or the input device 140A (if present). The processor of the controller 170A may execute the instructions stored in the memory device, and in doing so, may also read from the memory device or write to the memory device various information processed and / or generated according to the execution of the instructions. In various embodiments, the controller 170A may be or may include a microcontroller board.

[0034] Client device 135A may include a memory device 175A (such as a solid state drive (SSD) for (long-term) storage of data related to client device 135 (such as data about the state, status, and location of device 135A over time and proximity to the device). Although Figure 1135A. The device 135A may include one or more batteries for powering the various components. The one or more batteries may include separate batteries for the various components, one central battery for powering the various components, and / or one or more backup batteries in the event of a failure of the first battery. The batteries may be charged via a charging port of the client device 135A.

[0035] The exemplary computer device or computer system 100 includes, for example, one or more computer devices or computer systems of a logistics service provider, a shipping service provider, an electronic medical record (EMR) provider, a hospital or other healthcare service provider, a pharmaceutical company, etc. The exemplary client devices 135A and / or 135B may be user computing devices used by, for example, an entity (e.g., a healthcare provider) involved in initially obtaining a product (e.g., a biological sample); persons involved in transporting or otherwise handling the product in a chain of custody; individuals involved in handling the transported product; other users associated with a logistics service provider, a shipping service provider, an EMR provider, a healthcare service provider, etc.; and / or precision containers (see, e.g., Figure 3 In various embodiments, the computer device or computer system 100 and the one or more client devices 135A, 135B may be systems and devices of one entity or multiple entities.

[0036] Figure 2A 200 is a diagram illustrating a non-limiting example of a cyclic process 200 according to various potential embodiments. An article, sample, or product (collectively referred to as a "product" for convenience) may be collected from a source (e.g., collected from an individual or other "place") or otherwise obtained (205) as a first product. The first product may be transported (210) to a staging location (e.g., a pharmaceutical company, a manufacturing facility, etc.) for modification or other processing (215) or for deriving a second product based on the first product. According to various illustrative potential embodiments, the first product (or a second product derived from the first product) may be transported (220) back again for receipt (modified first product or newly derived second product) by the same source (e.g., the same individual or other place). Once the modified or derived product arrives at the place at the source, it may be provided to the place (e.g., injected into an individual) with or without further modification. Data (e.g., documentation, sensor readings, location records and actions taken, quality inspection information, etc.) is generated and / or modified at each step.

[0037] refer to Figure 2B, it should be noted that the source and destination do not have to be the same, and the routes taken can be very different. For example, a first individual may deposit or otherwise provide a product at a first location 255 (e.g., a first clinic or other collection location), which can be used as a starting point or source. A product that is in a first state when first obtained at a first location 255 (e.g., a starting point) can be optionally modified to be in a second state while still at the first location 255. The product (in a first state or a second state) can be fixed or otherwise positioned (e.g., by a first individual who can be a patient or by a second individual who can be a healthcare provider or other professional) in a precision container and the container is sealed. The container containing the product can be transported to a second location 260 (e.g., a first transfer location). At the second location 260, the product can be modified to a third state. Optionally, the container may also be transported to a third location 265 (e.g., a second staging location), where the container may be further modified to a fourth state, to a fourth location 270 (e.g., a third staging location), where the container may be further modified to a fifth state, and so on. The product (e.g., in the fifth state) may be transported from the final staging location (e.g., the fourth location 270, which may serve as the third staging location) to a fifth location 275 (e.g., a final destination for the product). The fifth location 275 may be the same as the first location 255, or may be different from the first location 255. For example, the final destination may be a second clinic, the home of the first individual, and the like, where the product may be removed from the container (by the first individual who provided the product, by the second individual, or by another individual (such as another healthcare provider)) for use or disposal.

[0038] The distances between locations may vary. For example, two locations may be in the same place (such as, for example, a transit location being "on the premises" relative to a previous location), or a subsequent location may be in another part of a city, in another city, in another state, in another country, or on another continent relative to a previous location. Data (e.g., documents, sensor readings, records of locations and actions taken, quality inspection information, etc.) is generated and / or modified at each location. The data may be stored in a memory of the container (e.g., a solid-state drive) and / or transmitted to an external device and / or system local to the container or remote from the container. In some embodiments, the data may be stored on a distributed ledger to enhance security and / or transparency.

[0039] The change of the state of sample or other contents may be caused by the addition, reduction or removal of materials in the container and / or the change of materials (e.g., materials are converted from one state to another state). In some embodiments, the modification of the product may not need to remove the product from the container. The state change modification of the product may include adding various materials (e.g., certain reactants or other reagents) through the opening in the container or to the chamber of the container. The modification may include applying electric and / or magnetic fields, emitting light of a specific wavelength, processing with a radiation source, storing under specific environmental conditions (e.g., specific temperature and / or humidity level), etc. It should be noted that the "modification" of the product used herein may refer to the change of state (e.g., the addition, reduction or conversion of compositions, reagents, components, etc.) and / or the generation of a second product derived from the original product (e.g., based on the content creation of the original product).

[0040] Figure 3 An exemplary system 300 is depicted showing interfaces between one or more exemplary containers 310 (e.g., client device 135A), one or more exemplary user devices 320 (e.g., client device 135B), and other devices or systems (e.g., computer device / system 100) that may be accessed via any of various communication networks 330. Precision containers 310 may be used to transport products from a source to a staging location where the products may be processed or otherwise modified and the modified products transported from the staging location to a source or another location. In various embodiments, container 310 may include a combination of devices or components disclosed herein. For example, the container 310 may include various sensors, such as: sensors that detect impacts to the container 310 to, for example, detect a drop or collision (e.g., using one or more accelerometers), sensors that measure temperature and temperature changes inside and / or outside the container or its contents (e.g., a product or modified product), sensors that detect humidity or moisture inside or outside the container or its contents, GPS or other location sensors, sensors for measuring the integrity of the container or its components (e.g., identifying potential breakage or other damage to the container or its contents by detecting sounds such as plastic or glass breaking, and / or piezoelectric sensors for detecting dents or other shape changes of the container that will produce detectable forces), sensors for detecting when the container (and / or its contents) is opened and closed and for how long, etc. Other exemplary sensors include orientation sensors (e.g., gyroscopes), atmospheric pressure sensors, proximity sensors for detecting objects in its surroundings, cameras and / or microphones for recording images, video, and ambient sounds around the container or its contents, proximity sensors for audio and / or visual input and / or output (e.g., speakers, light sources, touch screen or other displays, keyboards, etc.) to allow interaction with a user contacting the container 310, and the like. Figure 3 The components shown in are non-limiting exemplary components that may be incorporated into various embodiments of the precision container 310 , but any combination of the components disclosed herein may be incorporated into other potential embodiments of the container 310 .

[0041] The container 310 can communicate with one or more devices 320. Non-limiting examples of potential devices 320 include mobile or non-mobile devices such as smartphones, tablet computers, laptop computers, desktop computers, workstations, sensors, communication routers, mainframes, or other systems or devices. The devices 320 with which the container 310 can communicate can also include one or more other precision containers 310.

[0042] Device 320 may communicate directly, wirelessly, or by wire, and will be within the maximum range of the wireless or wired communication protocol being implemented. Communication between the container 310 and the device 320 can use one or more wireless or wired communication protocols, such as Wi-Fi, "Bluetooth" (e.g., "Bluetooth LE" for low-power devices), "Zigbee" (e.g., a specification based on IEEE802.15.4), LoRa (e.g., "long range" communication), "NBIoT" (Narrowband Internet of Things), Thread (e.g., an IPv6-based mesh network technology for IoT products), Near Field Communication (NFC), I2C (Inter-Integrated Circuit Bus), SPI (Serial Peripheral Interface Bus, Ethernet and / or other local area networks (LANs), RS-232 (Recommended Standard 232), RS-485, UART (Universal Asynchronous Receiver / Transmitter), USB (Universal Serial Bus, such as USB 1.1 using USB-A and / or USB-B connectors, USB 2.0 using USB-A, USB-B USB Micro A, USB Micro B, USB Mini A, USB Mini B and / or USB-C connectors, and / or USB 3.2 using USB-A, USB-B, USB Micro B and / or USB-C connectors).

[0043] The container 310 may also communicate with other devices and systems via other networks 330 (shown as a "cloud"), such as non-local devices and systems of other entities accessed via an Internet-based network. Communication with such other devices may be via a cellular network (e.g., 3G, 4G, 5G) or via other communication mechanisms (e.g., Wi-Fi). The other entities may be affiliated networks (e.g., the same entity with a shared security protocol) or non-affiliated networks (e.g., different entities with different security protocols). In a non-limiting example, the container 310 may communicate via the network 330 with devices or systems of any entity associated with any terminal location (e.g., source or destination) or any transit location (e.g., clinic, pharmacy, etc.).

[0044] Communications can be used for authentication (e.g., enabling or disabling a locking mechanism), verification (e.g., confirming that a particular action with respect to a container is permitted, confirming that a location is permitted, etc.), tracking (e.g., maintaining a record of the location of the container, environmental conditions surrounding the container, internal conditions or contents of the container, etc., and temporal data indicating when and for how long the container was in certain locations or environmental conditions or certain contents in the container), recording (e.g., what actions were taken with respect to the container at various locations, when they were taken, and by whom), and / or updating (e.g., changes to actions to be taken, information to be provided to or collected from an entity or individual interacting with the container, minimum and / or maximum internal and / or external environmental conditions that trigger an alarm condition, and / or firmware updates, etc.).

[0045] Figure 4 , Figure 5A and Figure 5B Components of an exemplary precision container (e.g., container 310) are depicted. Container 310 may include any of the components discussed with respect to client device 135A. In various embodiments, the container may be a "precision medicine container" (PMV), which is an IoT-enabled container that physically stores and controls proximity to a product (e.g., a patient specimen), asynchronously collects and outputs information about the specimen, and records interactions with the product. Here, IoT-enabled indicates that in various embodiments, the container is equipped with sensors (e.g., sensor 150A), processing capabilities (e.g., controller 170A), and the ability to connect and exchange data (e.g., via communication interface 145A) with other devices and systems over the Internet or via other communication protocols (e.g., RFID, NFC, and / or "Bluetooth").

[0046] The exemplary container physically includes an outer shell 400, an interior chamber 500 having one or more compartments 530 (such as drawers 510 and 520), and a locking mechanism 530 that secures these physical components together as a unit. The outer shell 400 can be five-sided (e.g., having a compartment structure without one of the six side walls (such as without a bottom or without a side wall)), so that the outer shell can slide over the interior chamber 500 (for securing the outer shell 400 with the interior chamber 500), and slide away from the interior chamber 500 (for removal or separation from the interior chamber 500).

[0047] The housing 400 can be insulated to reduce the amount of heat transferred into or out of the container 310. In some embodiments, the housing 400 can also be insulated to reduce electromagnetic radiation that penetrates into the container 310, such as light that can affect the contents of the container (e.g., if the container 310 contains light-sensitive components) and / or add heat and thereby increase the temperature inside the container 310. The 5-sided housing can be assembled over the interior of the drawer and locked in place to form an insulated container. The housing 400 can include a cutout 420 that is sized and shaped (e.g., circular) to receive or otherwise accommodate a protrusion of the locking mechanism 530. The protrusion extends through the cutout 420 and restricts the removal of the inner cavity from the housing when the locking mechanism is engaged, and does not restrict the removal of the inner cavity from the housing when the locking mechanism is disengaged.

[0048] The housing 400 may also include one or more interfaces 430 (e.g., I / O devices 140A and / or sensors 150A) for interacting with a user. The interfaces 430 may include, for example, any combination of one or more of the following: a display and / or visual indicator (e.g., an LCD screen, a touch screen display, and / or an LED light); an audio source (e.g., a speaker, an alarm, and / or other sounds for providing verbal or other feedback to the user); a keypad (e.g., with alphanumeric characters for entering a security code, etc.); a biometric scanner (e.g., a fingerprint reader or a facial scanner); and / or an input device (e.g., a microphone, a camera, or other optical reader for detecting the surrounding environment and / or for recording audiovisual images and / or video, etc.). The walls of the housing 400 may be made of high-density polyethylene and filled with insulating polyurethane foam to maintain temperature.

[0049] In various embodiments, the inner chamber 500 is a chamber having a plurality of parallel, horizontal drawers that are stacked one above the other and slide in and out to access the contents. The drawers can vary in size, number, and material to fit within the inner chamber and accommodate, for example, patient specimens, labels and packaging materials, cooling mechanisms (e.g., cold packs, refrigerants, dry ice, etc.), environmental requirements (e.g., vacuum insulation panels for insulating cryopreserved specimens), etc.

[0050] The interior chamber 500 may include a plurality of drawers 530, such as a drawer 510 for containing products (e.g., patient samples) and a drawer 520 for containing various components to interact with or otherwise affect the contents of the drawer 510. In various embodiments, the drawer 510 may include, for example, various components to regulate, monitor, and / or protect the contents of the drawer 510. For example, the drawer 510 may include any combination of one or more of the following: a shock absorbing mechanism (e.g., a clamp that secures a sample bottle with a spring that cushions the forces experienced by the sample bottle); a heat sink; and / or a sensor for detecting the condition of the drawer 510 (e.g., a sensor for temperature, humidity, the amount of light entering the drawer 510, etc.). The drawer 510 may include a slit 550 (or any other opening) to facilitate, for example, heat exchange between the drawer 510 and the drawer 520 and / or otherwise allow better access to the drawer 510 from the drawer 520.

[0051] In various embodiments, drawer 520 can contain components that can condition, monitor, and / or protect the contents of drawer 510. For example, drawer 520 can include any combination of one or more of the following: cooling components (e.g., cold packs, heat sinks, refrigeration mechanisms, and / or one or more fans) for reducing the temperature of the contents of drawer 510; heat sources (e.g., heat lamps, wires connected to a battery for generating heat, etc.) for increasing the temperature of the contents of drawer 510; light sources (e.g., emitting light of a specific wavelength that can provide an antibacterial or other effect in drawer 510); electromagnets (e.g., magnets that can be enabled to apply a magnetic field to the contents of drawer 510 when electrical energy is applied in different modes to, for example, attract, repel, or otherwise manipulate magnetic beads or other magnetic elements in a liquid to mix samples or other components of drawer 510); and / or humidifiers and / or dehumidifiers for varying the humidity of the contents of control drawer 510. Each drawer 530 can include a handle 560 to facilitate pulling the corresponding drawer out of the interior chamber 500. The handle 560 may be, for example, a projection or cutout that can be grasped more easily to pull the drawer open. In various embodiments, an integrated handle 585 located on the bottom of the inner chamber ensures that the housing is securely assembled with the inner chamber and can be picked up without uncoupling when unlocked.

[0052] Referring also to FIG. 9B , in various embodiments, the enclosed layer 570 may include a top portion of the inner chamber, thereby providing space for a controller (e.g., a microcontroller board), a "Bluetooth" module (and / or other communication interface), a solid state drive (SSD) (and / or other storage device), one or more batteries, and one or more sensor circuit connections to the sensor of the container. The electrical components may be enclosed in, for example, the top one inch of the inner chamber 500 (or other dimensions suitable for fitting the components). The enclosed layer 570 may be sealed by, for example, a 0.25-inch panel. The panel may be sealed or otherwise fixed, for example, at the center of two corners and opposite sides using one or more fastening mechanisms 580 (such as adhesives, 0.5-inch screws or other fasteners). The perimeter of the enclosed layer 570 may include a slit 590 (e.g., a drilled slit or other opening), which is located, for example, at the midpoint of the rear two corners and the left and right widths to accommodate sensor wiring extending from other places in the container (e.g., from one or more drawers 530) to the enclosed layer 570. In some embodiments, the enclosed layer 570 may be placed at another portion of the inner chamber 500. In other embodiments, the enclosure 575 may be combined with the housing 400 instead. In such embodiments, the controller in the enclosure 570 will communicate wirelessly or through wiring extending from the housing 400 to the interior chamber 500. In some embodiments, the enclosure 575 of the housing 400 may have one or more of the same components as the enclosure 570 in addition to the enclosure 570 of the interior chamber 500 to provide redundancy, for example, in the event of a failure of one of the components, or may have one or more different components, which are deemed appropriate based on considerations such as reducing potential sources of failure, undesirable heating from components in the enclosure 570 / 575, etc.

[0053] In various embodiments, the locking mechanism 530 may be operated by a servo motor. The servo motor may enable remote locking and unlocking by, for example, integrating a software application. The servo motor may communicate with a software application on a user's smartphone via a Bluetooth beacon (or other wireless communication), which may be embedded in the interior and connected to a microcontroller board. The user's smartphone (e.g., Figure 1 The client device 135B and / or Figure 4 The device 320 of the embodiment facilitates two-way communication between the container and the cloud computing environment (e.g., one or more computer devices / systems 100 accessed via the network 130) in which authentication is performed. Access is granted or denied based on the authorization and authentication requirements performed by the software application, thereby sending communication back through the user's smartphone to lock or unlock the container.

[0054] As an exemplary workflow regarding the locking mechanism 530, a user may log into an application on the device 320 and authenticate via the cloud. The "cloud" as used herein with respect to various embodiments refers to one or more computing devices / systems 100 with which the container 310 (or other client device 135A) and / or the user device 320 (or other client device 135B) communicate via a network 330. The user device 320 may connect to the container 310 via Bluetooth or any other communication protocol discussed herein.

[0055] In various embodiments, each time a user logs in and connects to a container via Bluetooth, USB, or other connection (wired or wireless), all data stored in the container's memory (e.g., the SSD of the PMV) is transmitted to the cloud (e.g., to a central system or device 100 that tracks and monitors containers). The container responds with a unique container ID, and the application running on the device 320 forwards the unique container ID to the cloud. The cloud (e.g., central system 100) responds with an indication of the user's actions authorized with respect to the specific container with the unique container ID.

[0056] In various embodiments, a user may request to unlock the container (e.g., by selecting an "open" icon in a graphical user interface or otherwise submitting a request to access the contents of the container via the application). The application then requests a one-time password (OTP) challenge from the container, which generates a time-based OTP ("TOTP") challenge (e.g., a challenge question that is only valid for a predetermined time, such as 1 minute, 5 minutes, 30 minutes, or 1 hour) via a software token. The application forwards the challenge to the cloud (e.g., central computing system 100), which generates an OTP based on the challenge. The cloud sends the OTP to the user application, which forwards the OTP to the container via the user's Bluetooth (or other) connection. The container then executes an unlock command to unlock the servo lock.

[0057] A baseline use case will now be discussed to illustrate aspects and features of various potential embodiments of the disclosed technology. In various embodiments, the container is a PMV that is used as a storage medium for patient samples involved in a medical procedure or process where the sample changes custody between individuals and / or organizations. The PMV ensures that the appropriate stakeholders have access to the specimen when it changes custody and monitors the condition of the specimen when it changes custody (e.g., the correct stakeholders in a known condition).

[0058] Various embodiments may employ asynchronous information: data generated by sensors, stored on the solid-state drive of the PMV, then transmitted via Bluetooth (or other communication protocol) to the user's smartphone and ultimately to a cloud environment for processing. The PMV's microcontroller board may house sensors that generate information related to piezoelectric measurements of: pressure, acceleration, temperature, strain, or force; location / GPS; humidity; proximity; rotation; gas or chemical levels; and / or the state of a locking mechanism (e.g., open / unlocked vs. closed / locked).

[0059] In various embodiments, the container can record interactions: data generated by physical interactions with the PMV facilitated by the software application. As used herein, a container can employ an authentication request (e.g., the individual is the individual referred to by the authentication request) and an authorization request (e.g., the individual is allowed to do what the individual is asked to do) to determine whether and when to lock and / or unlock a locking mechanism to open (allowing a user to access one or more portions of the container (such as one or more drawers)) or close the container (restricting access to one or more drawers).

[0060] In some embodiments, different users (e.g., specific individuals, specific entities, specific devices or systems, etc.) may be authorized to access different portions of a container, each portion being maintained differently or otherwise equipped differently (e.g., different sensors for different measurements related to the content to be stored in the portion, different components for maintaining different environmental conditions, etc.) as appropriate for the content to be placed in the portion. For example: a first user may be allowed to access a first drawer (but not a second drawer or a third drawer) with a first product (e.g., only when the first user is authenticated and only when the first user and the container are physically located at a particular location), so the first user may access the first product and replace the first product with the first modified product in the first drawer; a second user may be allowed to access a second drawer (but not a first drawer or a third drawer) with a second product (e.g., only when the second user is authenticated and only when the second user and the container are physically located at a particular location), so the second user may access the second product and replace the second product with the second modified product in the second drawer; and a third user may be allowed to access the first drawer and the second drawer (e.g., only when the third user is authenticated and only when the third user and the container are physically located at a particular location), so the third user may access the first modified product and the second modified product and generate a third product resulting from a combination of the first modified product and the second modified product. The third product may then be inserted into the first drawer, the second drawer, or a potential third drawer that is differently equipped to be suitable for storing the third product.

[0061] In various embodiments, the modified or derived product may be added to the same container from which the original product was obtained, or to another container. If the modified or derived product is added to the same container, in various embodiments, the container may be stored under various environmental conditions or kept in a "standby" mode to conserve energy. In certain embodiments, one or more batteries of the container may be rechargeable so that once the container is received, the container may, for example, be inserted or otherwise charged for use in the remainder of its chain of custody (or another segment). Recharging or other preservation operations may be required to authenticate or authorize a user to perform certain actions. In certain embodiments, an auxiliary drawer (e.g., a drawer with cold packs) may also be accessible to allow replacement of used components (e.g., replacing a used cold pack with a new one).

[0062] In various embodiments, a chain of custody can be maintained through a continuously changing digitally captured document of custody or control of patient samples. The components of the PMV can be configured to contain, for example, blood (human and / or other animals); bone marrow and stem cells; white and red blood cells (e.g., granulocytes, monocytes, lymphocytes, neutrophils, eosinophils, basophils, macrophages, erythrocytes, platelets); human cells (e.g., plasma, cytoplasm, ribosomes, and DNA); fresh, frozen, or formalin-preserved human tissue; organs and body parts (e.g., for transport for transplantation); ova / oocytes, fertilized eggs, and embryos; other body fluids (e.g., semen, saliva, urine, bile, mucus, breast milk, interstitial fluid (tissue fluid), chyme, exudate, hemoglobin, pus, and / or cerebrospinal fluid).

[0063] The subject matter and implementation of the operation described in this specification may be implemented in digital electronic circuits, or in computer software embodied in tangible media, firmware or hardware, including the structures disclosed in this specification and their structural equivalents, or a combination of one or more of them. The implementation of the subject matter described in this specification may be implemented as one or more computer programs, that is, one or more modules of computer program instructions, which are encoded on computer storage media for execution by data processing equipment or control of the operation of data processing equipment. The program instructions may be encoded on artificially generated propagation signals, such as machine-generated electrical signals, optical signals, or electromagnetic signals, which are generated to encode information for transmission to suitable receiver devices for execution by data processing equipment. The computer storage medium may be or be contained in a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. In addition, although the computer storage medium is not a propagation signal, the computer storage medium may include a source or destination of computer program instructions encoded by an artificially generated propagation signal. The computer storage medium may also be or be contained in one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).

[0064] The operations described in this specification can be implemented as operations performed by a data processing apparatus on data stored on one or more computer-readable storage devices or received from other sources.

[0065] The terms "data processing apparatus", "data processing system", "user device" or "computing device" cover all kinds of equipment, devices and machines for processing data, including, for example, a programmable processor, a computer, a system on a chip or multiple chips, or multiple or combinations of the foregoing. The apparatus may include a dedicated logic circuit system, for example, an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit). In addition to hardware, the apparatus may also include code that creates an execution environment for the computer program in question, for example, code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of the above. The apparatus and execution environment may implement a variety of different computing model infrastructures, such as network services, distributed computing, and grid computing infrastructures.

[0066] A computer program (also referred to as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program may be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language file), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store portions of one or more modules, subroutines, or codes). A computer program may be deployed to execute on one computer or on multiple computers located at one site or distributed across multiple sites and interconnected by a communication network.

[0067] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by special-purpose logic circuit systems (e.g., FPGA (field programmable gate array) or ASIC (application-specific integrated circuit)), and the device can also be implemented as a special-purpose logic circuit system.

[0068] Processors suitable for executing computer programs include, for example, both general-purpose and special-purpose microprocessors, and any one or more processors of any kind of digital computer. Typically, the processor will receive instructions and data from a read-only memory or a random access memory or both. The basic elements of a computer are a processor for performing actions according to instructions and one or more memory devices for storing instructions and data. Typically, the computer will also include one or more mass storage devices (e.g., magnetic disks, magneto-optical disks, or optical disks) for storing data or be operatively coupled to receive data from or transfer data to or both mass storage devices. However, the computer need not have such devices. In addition, for example, the computer may be embedded in another device, such as a mobile phone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a global positioning system (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), etc. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices, including, for example, semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.

[0069] To provide interaction with a user, embodiments of the subject matter described in this specification may be implemented on a computer having a display device for displaying information to the user, such as a CRT (cathode ray tube), plasma or LCD (liquid crystal display) monitor, and a keyboard and pointing device, such as a mouse or tracking ball, that the user can use to provide input to the computer. Other types of devices may also be used to provide interaction with the user. For example, the feedback provided to the user may include any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback), and input from the user may be received in any form, including acoustic, voice, or tactile input. In addition, the computer may interact with the user by sending documents to and receiving documents from a device used by the user; for example, by sending a web page to a web browser on a user's client device in response to a request received from the web browser.

[0070] The embodiments of the subject matter described in this specification may be implemented in a computing system that includes a back-end component (e.g., as a data server) or includes a middleware component (e.g., an application server), or includes a front-end component (e.g., a client computer with a graphical user interface or a web browser through which a user can interact with the embodiments of the subject matter described in this specification), or any combination of one or more such back-end components, middleware components, or front-end components. The components of the system may be interconnected by any form or media of digital data communication (e.g., a communication network). Examples of communication networks include local area networks ("LANs") and wide area networks ("WANs"), interconnected networks (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).

[0071] A computing system such as system 1900 or system 100 may include a client and a server. For example, content management system 130 may include one or more processors located in one or more data centers or server farms. Clients and servers are usually remote from each other and usually interact through a communication network. The relationship between a client and a server is generated by means of a computer program that runs on a corresponding computer and has a client-server relationship with each other. In some embodiments, a server transmits data (e.g., an HTML page) to a client device (e.g., for the purpose of displaying data to a user interacting with the client device and receiving user input from the user). Data generated at a client device (e.g., the result of a user interaction) can be received from a client device at a server.

[0072] Although this specification includes many implementation scheme details, these should not be interpreted as limiting the scope of any invention claimed, but rather as a description of the features of a particular embodiment specific to the system and method described herein. Certain features described in the context of an independent embodiment in this specification may also be implemented in combination in a single embodiment. On the contrary, the various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. In addition, although the features may be described above as working with certain combinations and even initially required, in some cases, one or more features from the claimed combination may be deleted from the combination, and the claimed combination may be directed to a variant of a sub-combination or a sub-combination.

[0073] Similarly, although operations are depicted in a particular order in the drawings, this should not be construed as requiring that such operations be performed in the particular order shown or in a sequential order, or that all illustrated operations be performed, to achieve the desired results. In some cases, the actions recited in the claims can be performed in a different order and still achieve the desired results. Furthermore, the processes described in the drawings do not necessarily require the particular order shown or sequential order to achieve the desired results.

[0074] In some cases, multitasking and parallel processing may be advantageous. In addition, the separation of various system components in the above-described embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product, or packaged into multiple software products. The components of the content management system 130 can be a single module, a logical device having one or more processing modules, one or more servers, or part of a search engine.

[0075] Now that some illustrative embodiments and implementations have been described, it will be apparent that the foregoing, which has been presented by way of example, is illustrative and not restrictive. In particular, although many of the examples presented herein relate to specific combinations of method actions or system elements, those actions and those elements may be combined in other ways to achieve the same goals. It is not intended that the actions, elements, and features discussed only in conjunction with one embodiment be excluded from similar effects in other implementations or implementations.

[0076] The embodiments of the above-described apparatus and processes are not intended to limit the above-described devices, apparatus, systems or processes in any way. Non-limiting potential embodiments relate to the application of the disclosed methods in general cell and gene therapy (CGT), involving the extraction of cells, proteins or genetic material from a patient or donor, modification thereof, and then reinjection of the modified material back into the patient, such as CAR-T therapy, an immunotherapy that uses a patient's T cells to fight cancer, providing patients with personalized treatment in addition to traditional chemotherapy, surgery and radiation therapy. However, the disclosed methods are not limited to such applications, but can be applied to other products, processes and entities.

[0077] As used herein and in the appended claims, unless otherwise specified herein or clearly contradicted by context, singular articles such as "a / an" and "the" and similar references in the context of describing elements (particularly in the context of the following claims) should be interpreted as covering both singular and plural. Unless otherwise indicated herein, the description of the range of values ​​herein is intended only to serve as a shorthand method for individually referring to each individual value within the range, and each individual value is incorporated into this specification as if individually described herein. Unless otherwise specified herein or clearly contradicted by context, all methods described herein can be performed in any suitable order. Unless otherwise stated, the use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to better illustrate the embodiment, and does not constitute a limitation on the scope of the claims. Any language in this specification should not be interpreted as indicating any non-claimed element as necessary.

[0078] As used herein, "about," "approximately," or "substantially" will be understood by one of ordinary skill in the art and will vary to some extent depending on the context in which it is used. If there is a use of a term that is not clear to one of ordinary skill in the art, then "about," "approximately," or "substantially" will mean up to plus or minus 10% of the particular term, taking into account the context in which the term is used—for example, "about 10%" will mean "9% to 11%." It should be understood that when "about," "approximately," or "substantially" precedes a term, the term should be interpreted as disclosing "about," "approximately," or "substantially" as well as the term without "about," "approximately," or "substantially" modification—for example, "about 10%" discloses "9% to 11%" as well as disclosing "10%."

[0079] As will be understood by those skilled in the art, for any and all purposes, particularly with respect to providing a written description, all ranges disclosed herein also encompass any and all possible sub-ranges and combinations of sub-ranges thereof. Any listed range can be easily considered to fully describe and enable being decomposed into at least equal two, three, four, five, ten, etc., the same range. As a non-limiting example, each range discussed herein can be easily decomposed into a lower third, a middle third, and an upper third, etc. As will be understood by those skilled in the art, all languages ​​such as "at most", "at least", "greater than", "less than", etc. contain the enumerated numbers, and refer to the subsequent decomposable ranges of the sub-ranges as described above. Finally, as will be understood by those skilled in the art, the range includes each individual member. Therefore, for example, a group having 1 to 3 items or components refers to a group having 1, 2 or 3 items or components. Similarly, a group having 1 to 5 items or components refers to a group having 1, 2, 3, 4 or 5 items or components, etc.

[0080] The words and terms used herein are for illustrative purposes and should not be considered limiting. The use of "comprising," "including," "having," "containing," "involving," "characterized by," "characterized by," and variations thereof herein is intended to encompass the items listed thereafter, their equivalents and additional items, and alternative embodiments consisting of the items specifically listed thereafter. In one embodiment, the systems and methods described herein consist of one, more than one, each combination, or all of the described elements, acts, or components.

[0081] Any reference to an embodiment or element or action of a system and method mentioned herein in the singular may also encompass an embodiment including a plurality of these elements, and any reference to any embodiment or element or action herein in the plural may also encompass an embodiment including only a single element. Reference in the singular or plural form is not intended to limit the currently disclosed system or method, its components, actions or elements to a single or multiple configurations. Reference to any action or element based on any information, action or element may include an embodiment in which the action or element is based at least in part on any information, action or element.

[0082] Any embodiment disclosed herein may be combined with any other embodiment, and references to "an embodiment," "some embodiments," "alternative embodiments," "various embodiments," "one embodiment," etc. are not necessarily mutually exclusive, and are intended to indicate that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment. Such terms as used herein do not necessarily all refer to the same embodiment. Any embodiment may be inclusively or exclusively combined with any other embodiment in any manner consistent with the aspects and embodiments disclosed herein.

[0083] References to "or" may be construed as inclusive, so that any term described using "or" may mean any of a single, more than one, and all of the described terms.

[0084] Where technical features in the drawings, detailed description or any claims are followed by reference numerals, the reference numerals have been included for the sole purpose of enhancing understanding of the drawings, detailed description and claims. Therefore, reference numerals or their absence shall not have any limiting effect on the scope of any claim element.

[0085] Without departing from its characteristics, the systems and methods described herein may be embodied in other specific forms. Although the examples provided herein relate to augmented reality experiences, the systems and methods described herein may include applications in other environments. The foregoing embodiments are illustrative rather than limiting of the described systems and methods. Therefore, the scope of the systems and methods described herein is indicated by the appended claims rather than the foregoing description, and changes within the meaning and scope equivalent to the claims are included therein.

[0086] Unless expressly indicated to the contrary, the indefinite articles "a," "an," and "an" as used herein in the specification and claims should be understood to mean "at least one" or "one or more."

[0087] References to "or" may be interpreted as inclusive, so any term described using "or" may mean any of a single, more than one, and all of the terms described. For example, reference to "at least one of 'A' and 'B'" may include only "A," only "B," and both "A" and "B." Such references used in conjunction with "including" or other open terms may include additional items.

[0088] Where technical features in the drawings, detailed description or any claims are followed by reference numerals, the reference numerals have been included to enhance understanding of the drawings, detailed description and claims. Therefore, reference numerals or their absence shall not have any limiting effect on the scope of any claim element.

[0089] The systems and methods described herein may be embodied in other specific forms without departing from their characteristics. The foregoing embodiments are illustrative rather than limiting of the described systems and methods. Therefore, the scope of the systems and methods described herein is indicated by the appended claims rather than the foregoing description, and changes within the meaning and scope equivalent to the claims are included therein.

Claims

1. A precision container, comprising: An outer shell and an inner chamber mounted in the outer shell, the inner chamber comprising a plurality of compartments, the plurality of compartments comprising: a first compartment for removably receiving a product; and a second compartment including one or more environmental control mechanisms; a sealing layer including a controller and one or more communication interfaces, wherein the one or more communication interfaces are used to communicate with one or more devices outside the precision container; a plurality of sensors for monitoring the first compartment, the plurality of sensors coupled to the controller of the enclosure; and A locking mechanism, which when engaged secures the housing to the interior chamber and, when disengaged, unlocks the housing from the interior chamber, thereby enabling access to the first compartment. 2 . The precision container according to claim 1 , wherein the one or more environmental control mechanisms of the second compartment include a cooling mechanism.

3. The precision container according to claim 2, wherein the cooling mechanism includes a refrigeration mechanism that adjusts refrigeration based on a signal from the controller.

4. The precision container of claim 2, wherein the cooling mechanism comprises a cold bag. The precision container according to claim 1 , wherein the sealing layer is fixed to the inner chamber. 6 . The precision container according to claim 1 , wherein the sealing layer comprises one or more openings for allowing wiring from the plurality of sensors to enter the sealing layer.

7. The precision container of claim 1, further comprising an output device, wherein the controller is configured to generate an audiovisual indicator indicating a malfunction of the precision container upon detecting a measurement value at or above a threshold.

8. The precision container of claim 1, wherein the second compartment is sealed such that access to the second compartment is restricted when the locking mechanism is disengaged.

9. The precision container according to claim 1, wherein the plurality of sensors includes a biometric sensor for authenticating a user before the locking mechanism is disengaged.

10. The precision container of claim 1, wherein the sealing layer further comprises a memory device, and wherein the controller records data each time an attempt is made to access the precision container.

11. The precision container according to claim 1, wherein the plurality of sensors include an accelerometer for detecting a force experienced by the precision container.

12. The precision container according to claim 1, wherein the plurality of sensors include humidity sensors.

13. The precision container according to claim 1, wherein the plurality of sensors include temperature sensors.

14. The precision container according to claim 1, further comprising a positioning device.

15. The precision container of claim 14, wherein the positioning device periodically detects the position of the precision container and transmits the position to the system via the one or more communication interfaces.

16. The precision container of claim 14, the precision device further comprising an accelerometer, wherein each time a force exceeding a threshold is detected using the accelerometer, the controller uses the positioning device to detect the position of the precision container.

17. A method of using a precision container, The precision container comprises: an outer shell and an inner chamber mounted in the outer shell, the inner chamber comprising a plurality of compartments, the plurality of compartments comprising a first compartment and a second compartment, the second compartment comprising one or more environmental control mechanisms; a sealing layer including a controller and one or more communication interfaces, wherein the one or more communication interfaces are used to communicate with one or more devices outside the precision container; a plurality of sensors for monitoring the first compartment, the plurality of sensors coupled to the controller of the enclosure; as well as a locking mechanism that engages to secure the housing to the interior chamber and disengages to unlock the housing from the interior chamber, thereby enabling access to the first compartment; and The method comprises: placing a product into the first compartment at a first location; assembling the housing over the interior chamber; and The locking mechanism is engaged to secure the housing to the interior chamber.

18. The method of claim 17, wherein engaging the locking mechanism comprises using an application executing on a user device in communication with the precision container.

19. The method of claim 17, wherein the product is a sample, the method further comprising collecting the sample from a subject.

20. The method of claim 17, wherein the product is a first product, and wherein the precision container is a first precision container, the method further comprising removing a second product from the first precision container or the second precision container and administering the second product to a subject, wherein the second product comprises a modification or derivative of the first product placed in the first compartment of the first precision container.

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