Powered sampling device

Abstract

Provided herein are powered sampling systems, devices, and methods for surface sampling. A portable handheld sampling device can include an actuator operably coupled to a sampling head that supports a sampling medium. One or more sensors indicate when the sampling device applies an appropriate force or pressure and duration of sampling. The actuator can provide motion, such as rotational motion, of the sampling medium. The sampling device can provide guidance to a user to facilitate standardized sampling according to a sampling protocol. The sampling device and system can include a communication device to facilitate automatic sampling logs and periodic updates of the sampling protocol. Systems for creating and managing sampling plans and test results are also provided herein.

Description

[0001] Cross-references to related applications

[0002] This application is a non-provisional application and claims priority to U.S. Provisional Application No. 62 / 838,635, filed April 25, 2020, the entire contents of which are incorporated herein by reference.

[0003] This application relates generally to the following applications: PCT application No. US2018 / 045699, filed August 8, 2018, and U.S. Provisional Application No. 62 / 711,167, filed July 27, 2018, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0004] This invention relates to systems, apparatus, and methods for sampling, particularly surface sampling. Background Technology

[0005] Sampling is performed on the surface of many analytes, including toxins, biological products, microbial flora, and other residues. Most of this sampling is done manually by wiping or applying various swabs, fabric samples, and other absorbent materials (such as sponges, cotton balls, or various paper products) to the surface to be sampled.

[0006] Surface sampling can be performed to detect the presence / absence of an analyte or for quantitative analysis. In either case, sensitivity and accuracy are highly dependent on the skill and expertise of the person performing the sampling. Many potential factors can alter the results, including but not limited to: the sampling area, the amount of overlap within the area, the pressure applied, and the extent to which the sampling device is used across the entire surface. Manual sampling also tends to be inconsistent between individuals collecting samples and between different sampling times. Consistency of a specific sampling protocol is always a problem.

[0007] Furthermore, surface sampling and most other sampling processes typically require metadata collection. At a minimum, knowledge of what was sampled, its location, and the time is needed for the results to be meaningful. Other aspects, such as who sampled, the batch number of the sampled population and the sampling device, and the specific sampling protocol, may also be important. The scope and type of metadata vary depending on the application.

[0008] Therefore, improved and more consistent sampling methods are needed, especially when samples are collected by multiple individuals. Improvements are also needed in sample data collection and logging. Furthermore, improved management and coordination of sampling, as well as better logging and verification of sampling locations, are also required. Summary of the Invention

[0009] In one aspect, the present invention relates to sampling systems, apparatus, and methods that facilitate surface sampling and improve the standardization of sampling. Such systems may include sampling devices with powered actuators, together with a sampling head, to standardize sampling conditions. These conditions may include, but are not limited to, any of the following: sampling pressure and area, sampling duration, and rotation of the sampling medium during sampling. In some embodiments, the apparatus communicates wirelessly with an Internet-enabled device (e.g., via radio waves, Bluetooth, infrared) to enable automated sample logging.

[0010] On the other hand, the sampling device acquires one or more attributes associated with sampling or a specific sample, and records or transmits said one or more attributes to the management system. The one or more attributes may include any of the following: sampling personnel, sampling device ID, location, sample type, size or ID, sampling duration, and time. In some embodiments, the sampling device may scan a location code and store the sample ID. For example, each location may have a QR code. When the code is scanned with the sampling device, sample information is stored by the sampling device and can be associated with the sample collected at that location. This streamlines the operator's recording of metadata. In some embodiments, this information is displayed on a screen display on the sampling device along with the time of sample collection. After sampling, the location code and sampling time are stored in the sampling device, which can be downloaded to a computer via a flash drive or wirelessly transmitted to a computer in the management unit. It should be understood that the screen display can be implemented in a portable handheld device, such as a smartphone, communicatively connected (e.g., wired connection, wireless communication) to the sampling device.

[0011] In some embodiments, the sampling system comprises two main parts: a powered sampling tool (e.g., an actuator, a driver) and a sampling head (e.g., a sampler). The sampling tool is at least partially powered and driven by electricity (e.g., a battery, a rechargeable battery, a hardwired power cord). Typically, the driven actuator includes a connector for attaching the sampling head. In some embodiments, the sampling device is configured to provide rotational movement of the sampling head (e.g., clockwise or counterclockwise) and may further include speed control. In some embodiments, the sampling device is operatively coupled to a processor control module, which includes a memory card capable of storing sampling information (e.g., sampling protocols) that can be periodically downloaded and updated via various means. In some embodiments, the sampling device has a control panel and a display to provide feedback to guide the user in surface sampling. Typically, the sampling head includes a cap, a rod attached to and extending distally from the cap, a sampling medium attached to or near the distal end of the rod, and a sample container (e.g., a tube, vial, or wide-mouth bottle). In some embodiments, the cap has a recess for receiving a component of the actuator (e.g., a rotatable shaft). In some embodiments, the cap has one or more openings for injecting material, such as additives, diluents, reagents, liquids, water, media, etc., into the tube when the cap is attached to a sample container. Such openings may be protected by a sliding or rotatable component (e.g., an upper cover) before and after material is added to the tube. In some embodiments, the inside of the cap has a rod attachment that can be connected to a sampling medium.

[0012] Sampling media can be various materials, such as cellulose, polystyrene, fabric, etc. Sampling components can be pads and can be wetted or otherwise treated for collection purposes. In some embodiments, the sampling media can be rotated in a circular motion on the sampling surface by an actuator of the sampling device to collect residues, microorganisms, or foreign matter. Sampling media can be used to sample various types of surfaces, such as environmental surfaces, manufacturing machinery, product surfaces, animal carcass surfaces, and conveyor belt surfaces. Typically, after sampling, the sampling media is placed in a tube to avoid contamination. The collected sample material can be processed and / or tested directly in the sample container (e.g., tube), or transferred for further processing or analysis. Tubes can be used as centrifuge tubes, filtration devices, or direct reaction tubes. The sampler can be used as an enrichment culture container. The entire sampler can be inserted into an instrument and analyzed automatically. It should be understood that while surface sampling is described herein, the management of sampling protocols and sampling plans, sample collection, and sample testing results can also be applied to various other types of sampling.

[0013] This type of sampling device can be further understood by referring to the following figures and detailed description. Attached Figure Description

[0014] Figure 1 An exemplary sampling device according to some embodiments is shown, which includes a sampling medium disposed in a sample container.

[0015] Figures 2A to 2B This illustrates the situation where the sampling medium is extracted from the sampling container. Figure 1 A view of an exemplary sampling device.

[0016] Figures 3A to 3B It shows Figure 1 The implementation scheme includes a sampling head with a sampling medium and a sample container.

[0017] Figures 4A to 4B It shows Figure 1 The actuator part of the sampling device in the implementation scheme.

[0018] Figures 5A to 7 A cap assembly for a sampling head according to some embodiments is shown, the cap assembly being connected to a sample container to contain the sampling medium before and after sampling.

[0019] Figure 8 to Figure 18B An alternative design for the actuator portion of a sampling device according to some embodiments is shown.

[0020] Figures 19A to 19B A sampling kit with a sampling head and a sample container is shown according to some embodiments.

[0021] Figures 20 to 21 Sampling methods according to some implementation schemes are shown.

[0022] Figure 22 An exemplary sampling device with an attached sampling kit is shown according to some embodiments.

[0023] Figure 23 An exemplary sampling system is shown, according to some embodiments, utilizing an exemplary sampling device that communicates with various computing devices.

[0024] Figure 24 An exemplary sampling system framework and related functions according to some implementation schemes are shown.

[0025] Figure 25 An exemplary sampling system workflow according to some implementation schemes is shown.

[0026] Figures 26A to 26C An exemplary sampling kit according to some embodiments is shown, the sampling kit including a sample container and a sampling head having attached sampling components.

[0027] Figures 27A to 27C Another exemplary sample rod for fixing a sampling component is shown according to some embodiments.

[0028] Figures 28A to 28D An exemplary sampling head with sampling components is shown before and after sampling according to some implementation schemes.

[0029] Figure 29 An exemplary power sampling device with a foldable actuator is shown according to some embodiments.

[0030] Figures 30A to 30D The following are illustrated according to some implementation schemes. Figure 29 Several views of an exemplary dynamic sampling device.

[0031] Figure 31 An exemplary power sampling device with a foldable actuator is shown according to some embodiments.

[0032] Figures 32A to 32E The following are illustrated according to some implementation schemes. Figure 31 Several views of an exemplary dynamic sampling device.

[0033] Figure 33 An exemplary operational view of a graphical user interface design for a powered sampling device, illustrating a sampling workflow according to some embodiments, is shown.

[0034] Figure 34 A sampling results control panel of a graphical user interface of an exemplary sampling management system according to some implementations is shown.

[0035] Figures 35A to 35B Another exemplary power sampling device according to some implementation schemes is shown.

[0036] Figures 36A to 36H The setup screen of a graphical user interface for a sampling system for facilitating sampling management, according to some implementation schemes, is shown. Detailed Implementation

[0037] This invention relates to sampling systems, sampling devices, and sampling methods. In one aspect, the invention relates to a portable powered sampling device that facilitates surface sampling and improves sampling consistency, thereby allowing for the standardization of surface sampling. The sampling device may include any of the features described herein or any combination thereof. Given the many ways in which these features can be combined, various aspects will be described separately before presenting exemplary embodiments. Typically, sampling requires determining the features to be included in a particular sampling device.

[0038] I. Standardized Sampling Protocol

[0039] In some implementations, the sampling system is configured to provide user feedback that guides or instructs the operator on where, how, and when to sample. These aspects may include a system sampling protocol. This system protocol may be stored on a processing module housed within the sampling device, or stored within a base station or data system. In some implementations, the data system may be connected to a cloud-based or Internet-based system and communicate via the communication module of the sampling device.

[0040] In one aspect, a sampling system includes placing the sampling medium of the sampling device into contact with the surface to be sampled and applying pressure or force to ensure adequate contact for surface sampling. Sampling protocols may include applying a specific pressure or force. In some embodiments, feedback and guidance include monitoring the pressure or force applied during sampling. Too little or too much force will result in results that are not comparable to or consistent with other samples. Different forces applied by different operators during sampling pose a challenge to providing consistent and reliable sampling results. Therefore, sampling criteria can be used to improve consistency and repeatability.

[0041] Sampling force or pressure is one aspect of standardization. Other aspects include sampling time and duration. Preferably, the sampling duration should be controlled. Typically, the overall sampling plan should require samples to be collected according to a set schedule.

[0042] II. Sampling device

[0043] In some implementations, the sampling device is configured to include features that allow for sampling standardization, which may include any one or all of the following:

[0044] • For standardized, controlled circular sampling areas;

[0045] • Automatic timed sampling interval; and

[0046] • Pressure sensors used during the sampling process;

[0047] A. Sampling medium / material

[0048] In one aspect, sampling devices include sampling media or materials suitable for a particular sampling operation. For example, materials approved for food contact should be used to sample food surfaces or food contact surfaces to avoid the possibility of unwanted contaminants. Most limitations of this type are known to those skilled in the art of food safety sampling, as some media are currently used for sampling surfaces. However, it has been noted that some materials have desirable properties and can be considered for specific applications; such materials may include, but are not limited to: cellulose foam or sponge, urethane foam or sponge, absorbent paper or pads, low-pile fiber blankets, and nonwoven fabrics, such as those made from polyolefin polymers. In some applications, sampling materials may include more abrasive and adhesive surfaces, which are suitable when it is necessary to remove portions of the surface rather than simply seeking to adhere material to it. All of the above-mentioned sampling materials retain residues of the material that came into contact with the sampling media.

[0049] In some implementations, the sampling material is a layered or laminated structure. When the sampling surface lacks the mechanical strength required for sampling, it can be reinforced or supported by one or more backing structures. In some cases, the sampling material will be bonded to or attached to a supporting material. This bonding can be mechanical, such as clips or fasteners, or more chemical, such as adhesives or other lamination processes. The sampling medium can even be attached to a container, as described below, to reduce material costs and potentially better meet certain sampling requirements.

[0050] For many applications, it is desirable for the sampling medium to retain its distinctive color if any part is lost during sampling. This is not the intended outcome, but such events do occur.

[0051] B. Sampling Head

[0052] On the other hand, the sampling device includes a sampling head that contacts and supports the sampling medium. The configuration of the sampling material and the means of connecting it to the sampling head (which connects the sampling material to an actuator for sampling) can be adapted to a variety of surfaces and materials. In many applications, this attachment carrier and the sampling material can be considered as the sampling head. For most applications, if microorganisms are the sampling target, the sampling head will need to be sterile and suitable for collecting microorganisms. In other cases, it will be particularly clean to allow sampling of particulate, toxin, or trace materials. The size and shape of the sampling medium are generally limited by the container size, as described below. Typically, the sampling head will be removed from the container via the attachment actuator without contacting the sampling medium. It is often convenient to include the container closure as part of the sampling head to facilitate these operations.

[0053] In the embodiments described herein, the sampling medium is shown as a circular disk. The disk shape of the sampling medium is particularly useful, enabling its use with actuators that provide rotational motion. However, it should be understood that the sampling medium can have any suitable size and shape (e.g., square, rectangular, elliptical, etc.) which can vary depending on the application and type of sampling. The sampling head can include other shapes and still allow the invention to be performed in substantially the same or similar manner. For ease of use, it is desirable to attach the sampling medium to the sampling head for easy loading and unloading from containers, thus preventing contamination when the sample carrier needs to be stored during preparation for sampling or after sampling and before transport and analysis. In one aspect, providing multiple sampling media of a fixed size and shape (e.g., circular pads of a fixed diameter) allows for consistency among multiple samples, thereby improving the standardization of sampling. It should be understood that different types of sampling and testing can utilize sampling media of different sizes, shapes, or types.

[0054] In some embodiments, the sampling head includes a container closure and a shaft for attaching the sampling medium. The sampling head will typically include means for attaching the sampling head to an actuator. In some embodiments, the actuator includes a connector socket that engages with the shaft of the sampling head. In other embodiments, the actuator includes a shaft that engages with the sampling head. The actuator can include any suitable type of connector, with connections including, but not limited to, square or hexagonal sockets into which appropriate pins from the actuator can be inserted. It is understood that various other shapes are also feasible; for example, a simple slot can be used. In some embodiments, a locking mechanism is used to enhance the security of the mating.

[0055] In some embodiments, the sampling device includes a connector that connects the sampling head to the actuator. Typically, the connector includes a shaft or a socket that engages with the shaft of the sampling head. The connector can be any type of connection suitable for applying force from the actuator to the sampling head. In some embodiments, the connection also applies rotational force. Such connections can include, but are not limited to, any type of connection currently used for attaching other moving parts of sockets, drives, and tools to various manual and power actuators. In some embodiments, the shaft supporting the sampling medium can be molded as part of the enclosure or can be molded separately. The shaft length only needs to be sufficient to allow for the desired sampling. In some embodiments, the sampling medium can even be attached directly to the enclosure, avoiding parts of the sampling head and thus reducing costs. However, if vents are included in the enclosure for adding enrichment media, removing the shaft may complicate in-situ enrichment. The process of switching sampling heads needs to be aseptic to avoid cross-contamination of samples during microbial or other biological sampling.

[0056] A typical configuration attaches the sampling medium to an axis that is part of the sampling head, which is rotated to collect the sample. The medium can be attached at any point, but center attachment typically provides more passes over the sampling area with each rotation. Center attachment makes it easier for the sampling medium to slide into and out of the container, as will be discussed below. However, other configurations are consistent with the present invention and can allow for a better simulation of the current sampling pattern. This is especially true for actuators that oscillate back and forth rather than rotate. It should be understood that the actuator can be configured to provide oscillations of various kinds, such as back-and-forth rotational motion, linear back-and-forth motion in one or more directions, or any combination of motions. In some embodiments, the sampling device can select between different types of sampling motions, including but not limited to any of the sampling motions described herein.

[0057] In some implementations, the sampling head is at least partially made of metal, so that if the sampling head is lost in the product flow during food processing operations, it can be detected by a metal detector for rejection.

[0058] C. Sample container

[0059] On the other hand, the sampling device may include a sample container. A sample container is typically required to protect the hygiene and cleanliness of the sampling medium before use, and to protect the transported sample medium after sampling is complete. While it is preferable from a cost point of view to use the same container for both functions, two containers can also perform these functions. As mentioned earlier, the closure may be part of the sampling head. This again reduces the amount of material required and thus reduces cost. The closure can be attached to the body of the container in various ways to create a tight seal sufficient to maintain the hygiene and cleanliness of the sampling medium. Such a seal may be waterproof if required. Examples of these types of connections include threaded connections, typically with snaps, twist locks, or locking lugs that engage with the ridge friction due to the plasticity of the material. Other strategies may be considered, but these may increase costs due to the increased number of parts.

[0060] The size of the container affects the usability of the sampling system because its dimensions must be suitable for containing the sampling medium. When the sampling head is attached to the container before use, the container defines the required storage volume for each sample. After use, the container still occupies the same volume, but it also defines the amount of enrichment or extraction medium necessary to analyze the sample when the target is not analyzed in situ on the sampling medium. Some analytes are stained in situ, thus requiring neither extraction nor enrichment. Typical volumes are expected to be 50 ml to 150 ml, but special needs may allow for systems as small as a few ml and as large as 1500 ml; however, it should be understood that any suitable size can be used. Often, there is an economic incentive to minimize container size, but specific sampling requirements ultimately drive the container size.

[0061] The shape, rigidity, and materials used to manufacture containers are driven by both cost and function. Using containers that are already commercially available also has advantages. Various cylindrical containers with suitable features for attaching closures can be envisioned. Containers with conical bottoms and designed to allow centrifugation to precipitate analytes, particularly bacteria and other cells, offer particular advantages for some applications. If the container can be supported like some type of sleeve, the container itself does not need to support the full pressure of centrifugation. Many suitable materials exist, including polyolefins, polycarbonates, nylon, PET, PEEK, and other more unique materials that will have specific desired properties (e.g., cell non-adhesion or solvent resistance). Glass can be considered, but it is heavier and more brittle than plastic. In extreme cases, for some sampling applications, flexible containers, such as bags with simple rolled-line closures or plastic zippers, may be appropriately used.

[0062] In some cases, it is advantageous for the container to be transparent and have graduations indicating the filling volume. In other cases, the container can be manufactured to allow direct testing of the sample and reading of the results. In this case, one or more reagents can be added to the sample to allow incubation and / or a reaction to occur, and the results can be read directly. The material of the container does not interfere with this functionality. Having an opening in the closure can be advantageous, which can be used to add liquids to aid the analytical process, close during incubation or reaction time, and allow the mixture to be drawn out through the opening without removing the cap, thereby preventing contamination. The ability to open and close this opening enhances this utility. In some embodiments, the container may have a label or label area to facilitate recording of sampling and sample location. Such a label may be a barcode system, a QR code, or detectable using RFID.

[0063] D. Actuator

[0064] On the other hand, the sampling device includes an actuator. In some embodiments, the actuator is configured to provide guidance for the sampling process. In some embodiments, the actuator is configured to provide powered motion to move the sampling head and thus the sampling medium across the surface. Guidance will indicate how and where the sampling medium is moved. Inertial and / or position sensors (such as those used in mobile phones) can monitor displacement and velocity. Pressure transducers can monitor the force applied during the sampling process. In some embodiments, sensors are coupled to indicators (e.g., audio or video) that indicate to the user when a minimum pressure is met or when a rotational force is applied or completed. In some embodiments, the actuator is configured to provide rotational motion after sensing the minimum pressure required to reach sampling. These aspects guide the user to sample in a manner consistent with the sampling protocol. The duration of sampling is another feature that facilitates standardization. A timer can monitor how long the sampling pressure is applied and indicate to the user when the minimum duration has elapsed. Indicators (e.g., LEDs, screen displays) can be used to transmit and correct actions to the operator. In some implementations, the sampling device records and / or transmits any of the aforementioned sensor / timer measurements for association with the sample (e.g., a sample log). Measurement results can be recorded using an identifier associated with a specific sample. These characteristics can be downloaded each time the sampling device is used, or multiple sampling logs can be downloaded periodically by the sampling device. In some implementations, the sampling device automatically records / transmits sampling data to the sampling system to further simplify and streamline sampling. This approach ensures that repeatable sampling meets the required sampling protocol and that the sampling log is accurate.

[0065] The actuator will typically have a power source, usually a battery, which will drive a motor to provide the motive force for sampling. Simple rotational motion provided by a motor is most common. However, various other oscillations can be used to better simulate manual sampling techniques. The use of rechargeable batteries for this type of device is well-known. The sampling device can be charged directly with a wire connected to a docking station, or using a short-range charging system designed for smaller devices. For outdoor operation, charging using a solar array may be advantageous.

[0066] Although considered more cumbersome, the sampling can be powered by mechanical energy from a spring. Alternatively, the operator can squeeze a trigger or lever to provide mechanical energy for the sampling. This method is preferred for sampling operations where there is a risk of electrical ignition.

[0067] To enhance functionality, the actuator can be equipped with a light source to illuminate the sampling target. The actuator should contain enough metal to be rejected by metal detectors in many operations.

[0068] E. Additional features / functions

[0069] Many features exist that, when placed in multiple components such as the actuators of a sampling device, base station, and data system, can be used in combination or individually to produce the same functionality. Given that some of these functions involve only data, it may be advantageous to use a computer, mobile phone, or tablet computer employing data processing and communication features configured for use with the sampling system and / or sampling device described herein. However, these same features can be incorporated into new devices utilizing such the same technology. Therefore, the arrangement of these functions described below is exemplary, and many other arrangements are possible.

[0070] • Automatic generation and recording of metadata such as sample location, date, time, operator, and sample type, and communication with local databases or the cloud.

[0071] The system may include a data logger that provides feedback to the operator during sampling via printouts or via a video display or monitor.

[0072] • Barcode generation and scanning to track physical samples and facilitate analysis (avoiding potential errors by operators or analysts in transcription data).

[0073] • Voice recording conversion that converts speech to text allows for the capture of descriptive details without the need for a more traditional keyboard for data input.

[0074] Various modules can be connected via physical connections, such as when the actuator is connected to a base station, or via wireless connections, such as Wi-Fi, cellular (e.g., 4G LTE), or Bluetooth.

[0075] Metal detection.

[0076] • Confirming and reporting sampling locations is important for visualizing the obtained information. High-resolution GPS or augmented positioning systems can be linked to mapping software, thereby increasing the system's utility.

[0077] III. Examples

[0078] The following embodiments describe detailed examples of sampling devices and methods, workflows and management based on the inventive concepts described herein.

[0079] Figure 1An exemplary sampling device 30 is shown. The sampling device 30 includes a body having a proximal handle 32 and an actuator 34, with a shaft 36 extending from the actuator 34 and engaging with a sampling head portion carrying the sampling medium 10, which facilitates rotation of the sampling head portion during sampling. An indicator 38 (e.g., an LED) on the sampling device body can indicate to the user when sufficient pressure is applied and / or after a sufficient duration, or can indicate various other sampling conditions. The sampling head portion includes a cap 21, from which a rod extends distally to the sampling medium 10. The cap 21 seals the top of a sample container 20 such that the sampling medium 10 is contained within the sample container 20 before and after sampling. Typically, the shaft and rod are substantially rigid to allow the user to forcefully press the sampler against the surface to be sampled.

[0080] like Figures 2A to 2B As seen, when the sampling head portion is withdrawn from the sample container 20, the rod 14 extends to the sample medium support 12, the underside of which is attached to the sampling medium 10. The sample container 20 and the rod 14 are sized such that the sampling medium 10 is suspended within the sample container to maintain the integrity of the sampling surface before and after sampling. The cap may include a filling opening 25 to allow additives to be added to the sample container after sampling, as previously described.

[0081] like Figures 3A to 3B As seen, the cover portion includes a main cover 21 attached to the rod 14, which engages sealingly with an external thread (e.g., via an internal thread) along the top of the sample container 20. The cover portion may also include an upper cover 24 having a filling opening 25 to allow access through another opening 23 in the cover 22. The central opening 22 allows the actuator to pass through the rod to facilitate rotation of the sampling member during sampling. In this embodiment, the sample container 20 is partially cylindrical but has a tapered distal portion, which allows for additional space between the sampling member 10 and the bottom of the sample container.

[0082] Figures 4A to 4B It shows Figure 1 The actuator portion of the sampling device 30 in this embodiment. The proximal handle 32 allows the stabilizing portion of the sampling device 30 to be held by the user during sampling, and the user can apply pressure to the surface to be sampled through this stabilizing portion. The actuator portion 34 includes a rotatable connector 34a that engages with a shaft 36, which in turn engages with a correspondingly shaped connector socket 22 in the top of the cover 21 (see also...). Figures 5A to 5B ).

[0083] Figures 5A to 7An embodiment of the sampling head portion is shown, wherein the main cover 21 includes a filling opening 23 shaped like a curved groove and an upper cover 24 including a circular filling hole 25. The upper cover includes a large central opening 24a to allow the actuator shaft 36 to engage with a corresponding square connector socket 22 in the cover 21. The upper cover 24 includes an outer lip 24b that sealably engages with the top outer edge of the main cover 21, such that the cover assembly can be sealed by rotating the upper cover 24.

[0084] Figure 8 to Figure 18B An alternative design of a sampling device body 30 with an actuator and a handle portion is shown according to some embodiments. Each includes a proximal handle portion 32 and a distal actuator portion having an actuator connector for attaching an actuator shaft 36 (see [link]). Figure 9B (e.g., the hexagonal connector 32a). As mentioned above, it can be understood that such a design can use any suitable connector type or actuation means suitable for moving the sampling head portion.

[0085] Figures 19A to 19B Examples show those with Figures 3A to 3B The optional sampling head design has the same or similar features as the implementation scheme, but the sample container 20 is a standard cylinder with a flat bottom.

[0086] In a specific implementation, the sampling medium comprises two comb-shaped, cross-linked cellulose sponges moistened with phosphate buffer, attached to a sampling head fitted into a standard 50 ml conical centrifuge tube sample container. The closure may be a liquid-sealed slider on a shroud. The actuator may be a simple right-angle rotating tool with an inherent timer (e.g., a 20-second timer) that ensures standardized sampling time. Other aspects of sampling can be handled in a conventional manner. It should be understood that this is merely an example, and any of these aspects may be designed according to a specific application or sampling protocol.

[0087] Figures 20 to 21 Sampling methods according to some embodiments are illustrated. It should be understood that such methods may omit certain steps or include various other steps, such as any of those described herein, and still follow the inventive principles described herein.

[0088] Figures 22 to 23An example of a sampling device 30 is shown, which has additional features and functions to further improve sampling and standardization. The sampling device includes a display 31 communicatively coupled to a processing module configured to transmit one or more attributes of the sampling to the user and / or sampling administrator. In some embodiments, the one or more attributes presented on the display include, but are not limited to: date, time, operator / sampler, sample collection location, and sample type. Figure 22 As shown, the display 31 is integrated into the sampling device 30 itself. In some embodiments, the display 31 only displays sampling attributes associated with the sample, while sampling information can be input via an external device communicatively connected to the sampling device. The external computing device can be a user's smartphone, tablet, or other computer. In other embodiments, the display 31 can be a user interface that allows the user to directly input sample information. The sampling information can later be uploaded to another computer or server.

[0089] Figure 23 A sampling system is illustrated, wherein a sampling device 30 is communicatively coupled to additional computing devices 40, 50. A display may be located on one or more separate computing devices wirelessly coupled to the sampling device, such as display 51 on a desktop computer 50 or display 41 on a smartphone 40. The sampling device can be used in conjunction with a system such as a user's portable computing device or smartphone 40, and a laptop or desktop computer 50. In some embodiments, the method allows for additional functionality, such as communication with a sampling management unit, as further described below.

[0090] Figure 24 An exemplary sampling system framework and related functions according to some implementation schemes are illustrated. The framework comprises three main parts: a sampling unit 210, a management unit 220, and a testing unit 230. Each of these units can receive input and feedback to each of the other units. Typically, the sampling unit 210 feeds back sampling data to the management aspect by uploading sampling data, while the management aspect 220 feeds back to the sampling aspect 210 by assigning sampling tasks. Samples are sent from the management unit 220 to the testing unit 230. The management aspect 220 facilitates the testing function 230 by submitting test requests and test samples to the testing unit 230 and outputting sampling information associated with the samples to the testing unit 230 (laboratory). The testing unit then feeds back the test results to the management unit 220 for processing.

[0091] Sampling unit 210 includes sampling hardware, which includes a powered sampling device and a sampling head, such as any of those described herein. In some embodiments, the sampler includes an imager (e.g., a barcode scanner, RFID detector, etc.). The sampling head includes sampling components for acquiring a sample and a sample container (e.g., a vial, a wide-mouth bottle) for preserving the sample after sampling. Other features / functions of the unit may include: associating other sampling information with the sample (e.g., operator, date, and time), sampling point identification functionality (e.g., GPS, location detector), and barcode recognition.

[0092] Management unit 220 handles the management aspects of sampling, which may include the coordination and assignment of sampling, as well as the transmission and correlation of sampling information before, during, and after sampling. Hardware associated with the management unit may include any of the following: portable computing devices (e.g., smartphones, tablets), laptops or desktop computers, servers, or any combination thereof. Other features and functions associated with management unit 220 may include any of the following: sampling area and point setup (e.g., mapping), sampling planning, planning tracking and verification, data transmission and analysis, sampling and test reporting, sampling traceability, and sampling result alerts.

[0093] Test unit 230 may include various analytical hardware, such as barcode readers, automated liquid filling machines, test / analysis machines, and various computers (e.g., smartphones, tablets, laptops, desktop computers). Other features and functions may include any of the following: barcode recognition, sample matching, and automatic uploading of test results.

[0094] It should be understood that the features described above in the framework are exemplary, and one or more features may be excluded or additional features may be included. Furthermore, it is understood that input / output and feedback between units can be automatic, performed by the user using prompts or any combination thereof.

[0095] Figure 25An exemplary sampling system workflow according to some embodiments is illustrated. Workflow 300 includes a first step of assigning a sampling task, which can be performed by the aforementioned management unit. Then, in step 2, the workflow obtains operator, date, and time setting information via a powered sampling device. In step 3, a sampling location is selected, which can be entered into the sampling device by the user or can be performed automatically by the sampling device (e.g., via GPS, image scanning, or location detection). In step 4, the sampling device scans a barcode on the sampling container (e.g., a wide-mouth bottle, a vial) to record confirmation of the sample to be collected and associates the sample ID with the sampling location and / or other sampling information (e.g., time / date, operator, sampling attributes, etc.). In step 5, the user attaches a sampling head, including the sampling component, to the powered sampling device and then begins sampling. In step 6, after sampling, the user removes the sampling head with the sampling component and returns it to the sampling container. After sampling, the sample is sent to a laboratory for testing. In some implementations, the management unit can facilitate the entry of organizational sampling information into the laboratory. In step 7, each sample is verified. In some implementations, this requires scanning the barcode label on the sample container for sample registration, thereby matching each sample with the corresponding sampling point. In step 8, sample processing and analysis are performed, which can be done by the testing unit. In step 9, the test results are uploaded and can then be submitted to the management unit, which can generate a sampling result report, generate alerts, and / or determine the need for further sampling as appropriate.

[0096] Figures 26A to 26C An exemplary sampling container with an integrated sampling member and container cap, according to some embodiments, is shown. Similar to previous sampling heads, this embodiment includes a main cap 21, with a rod 14 extending distally from the main cap 21 to the sampling member 10. Figure 26C As shown, the main cover 21 includes a central hexagonal opening 22a for the actuator to pass through and a circular filling opening 25. The upper cover 24 includes a circular filling opening seal 25a that engages sealingly around the filling opening 25 when the interface cover 24 is placed on top of the main cover 21. The upper cover 24 also includes a central opening 22 through which the actuator extends.

[0097] Figures 27A to 27C It shows Figure 26BAn exemplary sampling member rod 14 of the sampling head is shown. This rod design allows the sampling member to be easily attached to the end of the rod 14 for sampling and to be removed if necessary after sampling. This is advantageous because it allows for easy replacement or substitution of the sampling medium if a specific type of sampling medium is required for a particular application. In some embodiments, a sampling container with an attached sampling medium is provided to the user, and the sampling medium can be used for sampling and sealed within the sample container without requiring the user to replace or substitute the sampling medium. In the illustrated embodiment, the rod 14 includes a proximal base 14a that is matingly received within a central jack in the main cover 21. Figure 27C As shown, the proximal base 14a can be shaped and include a ridge feature for easy attachment to the cap. Two arms 14b1, 14b2 extend distally from the proximal base 14a. At the distal end, one arm 14b1 includes a hook 14c1 extending into a corresponding recess or hole within the opposing arm 14b2. This design allows for the removal of a central hole or slot (see [reference needed]) when the other arm 14b2 is lifted. Figure 28A A planar sampling medium (e.g., sponge, cloth, gauze) is placed on a hook. After the sampling medium is placed, another arm is released and it elastically returns to its undisplaced position to accommodate the hook in the corresponding hole, thereby securing the sampling medium in place. This method allows for easy removal of the sampling medium if needed, but sufficiently secures it to allow for the application of appropriate force and pressure during dynamic sampling. For example, as described above, the sampling medium can be pressed or rotated with appropriate force to apply torsional motion to the sampling medium.

[0098] Figures 28A to 28DExemplary sampling members according to some embodiments are shown, along with views of the sampling member mounted on the rod of the sampling head before and after sampling. In this embodiment, the sampling member is a piece of cellulose fiber to absorb liquid residues from the sampled item. Preferably, the sampling member is sized to fit within a sampling container. Typically, the sampling member is rectangular and has a length and width of 0.5 inches to 4 inches, but it can be defined as any desired size and shape. In this embodiment, the sampling member 10 is rectangular in shape, having a length of approximately 1.5 inches and a width of approximately 1 inch. A retaining hole 11 is formed along the upper center of the sampling member to allow the sampling member to be secured to the distal end of the rod 14 and to extend toward the distal end of the rod, thereby facilitating sampling. In this embodiment, the retaining hole 11 is approximately 2 mm × 6 mm. This design allows the sampling member 10 to be accommodated within a standard sampling bottle or vial with a height of approximately 3.5 inches and a diameter of 2 inches. For most sampling applications, sampling components and containers can be within 50% of the dimensions described above, as this allows for obtaining suitable samples and enabling the collection of large quantities of samples. It should be understood that various other sizes and shapes of sampling containers can be used, which may require corresponding sampling components of different sizes and shapes to be housed within them.

[0099] Figure 29 An exemplary dynamic sampling device 30' according to some embodiments is shown. This design includes features similar to those previously described. Figure 22 The design has the same or similar features (mentioned similarly), but includes an actuator design that folds upwards into the body of the sampling device, such as... Figure 30B As shown. Figure 30A As shown, this design includes a cap 15 that engages with the cover 21 of the sampling head to further improve the rotation of the sampling head during sampling. This design may also include a cover 34c' that covers the folded actuator arm. In this embodiment, multiple control buttons 33 on the proximal handle 32 are used to control the device. This design also includes a user interface 31 that uses a touchpad to display and receive user input. This embodiment also includes a reader 39 (e.g., an imager, scanner, detector) that allows the user to scan, image, or detect the barcode of the sampling location and / or the sampling head to be used during sampling.

[0100] Figure 31 Another exemplary power sampling device 30 is shown according to some embodiments. This design includes features similar to the previous one. Figure 22 The design has the same or similar features (mentioned similarly), but includes an actuator design that folds upwards into the body of the sampling device, such as... Figure 30B As shown. Figure 30AAs shown, this design also includes a cap 15 that engages with the cover 21 of the sampling head to further improve the rotation of the sampling head during sampling. In this embodiment, a plurality of control buttons 33 on the proximal handle 32 are used to control the device. This design also includes a user interface 31 that uses a touchpad to display and receive user input. This embodiment also includes a reader 39 that allows the user to scan, image, or detect the barcode of the sampling location and / or the sampling head to be used during sampling.

[0101] Figure 33 An exemplary general workflow 300 according to some embodiments is illustrated, showing various views of a graphical user interface design for a powered sampling device. In step 1, screen view 301 shows user login on the sampling device. In step 2, screen view 302 shows a list of sample plans displayed to the user. In step 3, screen view 303 shows sampling routine details, such as the sampling point to be sampled (e.g., wall, countertop, floor, instrument, etc.). In step 4, screen view 304 shows detailed instructions for a given sampling location and prompts the user to obtain identification information for the sampling head. The user can choose to scan (e.g., barcode or RFID) or manually enter the sample container identification number. In step 5, screen view 305 shows the sample container ID and prompts the user to start sampling. The user then samples with the powered sampling device, which may include any sampling features described herein (e.g., applying pressure and / or rotation to a sampling member connected to the sampling device). In step 6, screen view 306 shows sampling in progress, and when complete, the user presses "Done". In step 7, screen view 307 prompts the user to save the sampling information associated with the recently collected sample. In step 8, screen view 308 shows the current sampling routine and indicates which samples have been collected and which have not. As shown in box 309, steps 3 through 7 are repeated for each sampling point location in the routine until completion and all sampling points are saved. As shown in screen view 310, once the routine is complete, the user can press “TaskComplete”, and the workflow returns to screen view 312, which shows the tasks completed throughout the entire sampling plan list. For each routine in the sampling plan list, the steps in boxes 302 through 312 can be repeated. While the above represents an exemplary sampling workflow, it should be understood that various other screen views may be included, or those shown may be modified as needed.

[0102] Figure 34A management control panel 500 for an exemplary sampling system with a graphical user interface according to some embodiments is shown. As shown, the control panel 500 includes different boxes representing different aspects of the overall sampling system, such as sampling plan 501, operator 502, and device 503. Each of these can be selected to view and evaluate information related to these different aspects. The control panel also includes a sampling report area 504 and a sampling point report area 505, which indicates sampling information and test result information from past sampling. In one aspect, by grouping the sampling information according to these different attributes, system administrators can view and identify trends regarding each of these attributes individually or in combination, which helps in understanding changes in sampling. In another aspect, this allows administrators to determine sampling needs or understand trends or changes in sampling locations.

[0103] Figures 35A to 35B An exemplary power sampling device 30”' according to some embodiments is shown. This design includes features similar to previous... Figure 22 and Figures 29 to 31 The design has the same or similar features (mentioned similarly). As shown, this design includes an actuator connector 34b for connection to a removable actuator rod, and a reader 39 (e.g., an imager, a scanner) as described in previous embodiments.

[0104] Figures 36A to 36H Setup screens for managing a sampling system to facilitate sampling, according to some implementation schemes, are shown. These screens can be included in a sampling setup wizard, guiding the user through the process of setting up sampling plans and routines. The screens can be viewed in a graphical user interface of a computing device (e.g., a smartphone, tablet, laptop, computer) communicatively connected to the system, typically within a management unit. Figure 36A As shown, the sequence includes box 361, where the user selects or creates a new sampling location. Figure 36B As shown, the sequence includes box 362, where the user can specify additional attributes for a given sampling location, such as status, location name, and region name. Figure 36C As shown, the settings may include box 363, where users can create, modify, or view sampling plans. For example... Figures 36D to 36F As shown, the settings can include boxes 364, 365, 366, and 367, where users can enter, modify, or view various properties of the sampling plan. Once complete, the status of multiple sampling plans can be viewed or managed (e.g., assigned, completed), such as... Figure 36HBox 368 is shown. It should be understood that the above-described boxes are exemplary and various other screens or modifications may be used as needed. These setup screens exemplify certain executable aspects that can be viewed by an administrator through the management unit. Typically, these screens are included in the application framework on the computing device of the management unit and are included in programmable instructions recorded in the memory of the computing device.

[0105] In some embodiments, the sampling device includes wireless capabilities (e.g., RFID reading and scanning, Wi-Fi, Bluetooth data communication, near-field communication). In some embodiments, the sampling device includes a scanner for QR scanning. In some embodiments, the sampling device includes RFID reading / scanning functionality, which can supplement or replace conventionally used QR scanning by employing an RFID reader to detect an RFID chip fixed at a specific sampling location. This can be used to ensure that samples are actually collected from designated sampling locations (compared to QR codes, which can be easily copied and moved). In some embodiments, the sampling device can generate barcodes that can be printed and scanned by the sampling device or by a separate component communicatively coupled thereto. This can be used to mark sampling locations and / or mark sampling containers at each sampling location.

[0106] In another aspect, the sampling device may include additional features programmed on the sampling device itself or on a separate component (e.g., a smartphone, tablet, or laptop) wirelessly connected thereto. These additional features may be implemented as software stored in the memory of the processing module. The additional software features may include, but are not limited to, any of the following: user classification (e.g., different roles: supervisor, manager, or operator); authorized user input to set sample location, date and time, username, and test type; data logger functionality and analyzer; data mapping to sample collection location (e.g., mapping); timers for setting timed sampling intervals; generation of test reports; alarms when data samples exceed user-defined thresholds; warnings; data archiving / retrieval based on test results to trace contamination points; or any combination of these features.

[0107] It should be understood that any sampling apparatus or system according to the concept described herein can be used to facilitate any of the sampling methods and approaches described in PCT application No. US2018 / 045699 (included in the appendix), filed August 8, 2018. In some embodiments, the sampling apparatus may be configured to perform one or more steps in a particular sampling protocol to improve sampling and standardization, as described herein.

[0108] While exemplary embodiments have been described in detail by way of example for clarity of understanding, those skilled in the art will recognize that various modifications, adaptations, and changes can be made. For example, although a fully portable handheld sampling device has been described herein, it should be understood that the sampling device can be incorporated into a cart-based system (e.g., hardwired to a power supply or computer cart). Therefore, the scope of the invention should be defined only by the appended claims.

[0109] In the foregoing description, the invention has been described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. Various features, embodiments, and aspects of the invention described above can be used alone or in combination. Furthermore, without departing from the broader spirit and scope of this specification, the invention can be used in any number of environments and applications other than those described herein. Therefore, the specification and drawings should be considered illustrative rather than restrictive. It should be understood that the terms “comprising,” “including,” and “having” as used herein are specifically intended to be interpreted as open-ended technical terms.

Claims

1. A sampling device for surface sampling, the sampling device comprising: A sampling head configured to support and engage a sampling medium configured for surface sampling, wherein the sampling medium is attached to a distal portion of the sampling head. An actuator configured to releasably engage the sampling head and provide power to the sampling head, thereby moving the sampling medium when it is attached to the sampling head during sampling; and A sample container configured to contain the sampling medium while being attached to the sampling head. The sampling head includes a proximal connector that is sealed to the top opening of the sample container so that the sample container contains the sampling medium while being attached to the sampling head.

2. The sampling device as described in claim 1, further comprising: A handle for manually holding the sampling device during sampling, wherein the handle is a proximal portion of the housing, and the actuator is at least partially disposed within the housing.

3. The sampling device as described in claim 1, further comprising: A sensor configured to sense the force or pressure applied to a surface by the sampling head during sampling.

4. The sampling device as described in claim 3, further comprising: A pressure indicator that instructs the user when a minimum force or pressure is applied to the surface during sampling.

5. The sampling device as described in claim 1, further comprising: A timer configured to monitor the duration of application of the sampling device.

6. The sampling device as claimed in claim 1, further comprising: A time indicator configured to indicate to the user when a minimum time has elapsed during the application of the sample.

7. The sampling apparatus of claim 1, wherein the actuator includes an oscillation mechanism that causes the sampling head to oscillate back and forth so as to oscillate the sampling medium when it is coupled to the sampling head during sampling.

8. The sampling apparatus of claim 1, wherein the actuator includes a rotation mechanism that applies a rotational force to the sampling head to rotate the sampling medium when the sampling medium is coupled to the sampling head during sampling.

9. The sampling device of claim 8, wherein the rotation mechanism includes a connector between the actuator and the sampling head, wherein the connector is connected to the shaft of the actuator and / or the sampling head.

10. The sampling device of claim 1, wherein the sampling medium is an absorbent material that absorbs liquid residues on the surface upon contact.

11. The sampling device of claim 1, wherein the sampling head and the sampling medium have a generally circular cross-section, and the sample container is at least partially cylindrical.

12. The sampling device as claimed in claim 1, further comprising: A processing module configured to have programmable instructions recorded thereon, wherein the instructions include steps associated with a specific sampling protocol.

13. The sampling device as claimed in claim 12, further comprising: A sensor configured to sense pressure or force applied to a sample surface through the sampling head; The processing module is configured to perform the following steps: Sensing when the minimum force or pressure is applied, and Outputs an indication of the minimum force or pressure applied.

14. The sampling device as claimed in claim 13, further comprising: A timer configured to monitor the duration of the application of the minimum force or pressure. The processing module is further configured to perform the following steps: Receives input from the timer sensor and outputs commands, and Outputs an indication of when the minimum sampling duration has elapsed during the sampling period.

15. The sampling apparatus of claim 13 or 14, wherein the processing module is further configured to record the applied force or pressure and the elapsed duration, and to associate the recorded measurement results with a specific sample identifier.

16. The sampling device of claim 12, further comprising: A communication module configured to transmit an associated sample identifier to a sampling system communicatively connected thereto.

17. The sampling apparatus of claim 16, wherein the communication module is further configured to update the sampling protocol stored in the memory of the sampling apparatus.

18. The sampling device as claimed in claim 1, further comprising: A display configured to present one or more sampled attributes thereon, wherein the display is incorporated into the sampling device or disposed on other components wirelessly connected thereto.

19. The sampling apparatus of claim 18, wherein the display is a touch screen and is configured to receive input from a user to view, input, or modify the attributes of the sample before, during, or after sampling.

20. The sampling device of claim 1, wherein the actuator is a rod removable from the sampling device.

21. The sampling device of claim 20, wherein the actuator rod is foldable so as to fold inward against the sampling device when not in use.

22. The sampling apparatus of claim 20, wherein the actuator rod has a distal sampling head support, the distal sampling head support being shaped to engage with the proximal end of the sampling head.

23. The sampling apparatus of claim 22, wherein the distal sampling head support is generally circular, and the proximal end of the sampling head is a circular cap configured to sealably engage with the sampling container.

24. The sampling device as claimed in claim 1, further comprising: A reader configured to image or scan barcodes or QR codes, or for RFID detection, to confirm the sampling location and / or sample container.

25. The sampling device of claim 1, wherein the sampling medium is an absorbent material and comprises a nonwoven fabric made of a polyolefin polymer.

26. The sampling apparatus of claim 1, wherein the sampling apparatus and sampling medium are configured to sample a food surface or a food contact surface for food safety sampling.

27. A method for surface sampling using the sampling apparatus according to any one of claims 1 to 26, the method comprising: The sensor of the sampling device attached to the sampling medium senses the force or pressure applied to the surface by the sampling medium during sampling; Indicates when minimal force or pressure is applied; The duration is monitored using a timer on the sampling device; as well as An indication is given when the minimum duration of the sampling period has elapsed.

28. The method of claim 27, further comprising: The actuator of the sampling device actuates the movement of the sampling medium via a movable sampling head.

29. The method of claim 27, wherein the actuation motion comprises applying rotational motion to the sampling medium via one or more rotatable axes of the actuator and / or the sampling head.

30. The method of claim 27, further comprising: The processing module of the sampling device automatically records the applied force or pressure and the duration of the pressure, and associates the recorded measurement results with a specific sample identifier.

31. The method of claim 27, further comprising: The sampling device's communication module automatically transmits the recorded measurement results and associated sample identifiers to the sampling system it is communicatively connected to.

32. The method of claim 27, further comprising: One or more of the sampled properties are presented on a display, wherein the display is incorporated into the sampling device or is set on other components wirelessly connected thereto.

33. The method of claim 27, wherein the sampling medium is an absorbent material and comprises a nonwoven fabric made of a polyolefin polymer.

34. The method of claim 27, wherein the sampling device and sampling medium are configured to sample a food surface or a food contact surface for food safety sampling.

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