JP2021099372A - Systems, devices, and methods for bodily fluid sample collection, transport, and handling - Google Patents

Abstract

To provide bodily fluid sample collection systems, devices, and methods.SOLUTION: A sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. In one embodiment described herein, a device is provided for collecting a bodily fluid sample. In embodiments, the bodily fluid may be blood. In embodiments where blood is collected, this embodiment may be useful for accurately collecting small volumes of bodily fluid sample that are often associated with non-venous blood draws.SELECTED DRAWING: None

Description

(Background of invention)
Blood samples for use in clinical examinations are often obtained by means of venipuncture, which typically involves inserting a hypodermic needle into the subject's vein. Blood drawn by a hypodermic needle is either drawn directly into the barrel or into one or more sealed vials for subsequent processing. If venipuncture can be difficult, or if it is not feasible, such as in a newborn, non-venous puncture, such as puncture of the heel or puncture of another alternative site, is a blood sample sampling for examination. Can be used for. After the blood sample has been collected, the sample taken is typically packaged and transported to a processing center for analysis.

Unfortunately, conventional body fluid sample collection and testing techniques have drawbacks. For example, with the exception of the most basic tests, currently available blood tests typically require a significantly higher volume of blood to be drawn from the subject. Because of the high volume of blood, withdrawal of blood from an alternative sample site of a subject that is less painful and / or less invasive does not produce the volume of blood required for conventional testing methodologies. Not preferred. In some cases, patient anxiety associated with venipuncture can reduce patient compliance with patient testing protocols. In addition, transporting small volumes of sample fluid while maintaining integrity can be problematic.

(Gist of the invention)
At least some of the disadvantages associated with prior art are overcome by at least some or all of the embodiments described in this disclosure. Although embodiments herein are typically described in the context of obtaining blood samples, but not limited to, embodiments herein are not limited to blood samples and are for analysis. It should be understood that it can also be adapted to obtain other fluid or body samples.

In one embodiment described herein, a device for collecting body fluid samples is provided. In embodiments, the body fluid may be blood. In embodiments where blood is collected, this embodiment may be useful for accurately collecting small volume fluid samples often associated with non-venous blood sampling. In one non-limiting example, the sample volume is about 1 mL or less. Optionally, the sample volume is about 900 μL or less. Optionally, the sample volume is about 800 μL or less. Optionally, the sample volume is about 700 μL or less. Optionally, the sample volume is about 600 μL or less. Optionally, the sample volume is about 500 μL or less. Optionally, the sample volume is about 400 μL or less. Optionally, the sample volume is about 300 μL or less. Optionally, the sample volume is about 200 μL or less. Optionally, the sample volume is about 100 μL or less. Optionally, the sample volume is about 90 μL or less. Optionally, the sample volume is about 80 μL or less. Optionally, the sample volume is about 70 μL or less. Optionally, the sample volume is about 60 μL or less. Optionally, the sample volume is about 50 μL or less.

In one non-limiting example, the device can then be used to directly divide the fluid sample, placed in each sample container, into two or more different portions. In one non-limiting example, the instrument is a first portion having at least two sample collection channels configured to draw a fluid sample into a sample collection channel via a first type of driving force. One of the sample collection channels has an internal coating designed to mix with the fluid sample, and another one of the sample collection channels is chemically separate from the internal coating. Has an internal coating. The sample collection device includes a second portion containing a plurality of sample containers for receiving body fluid samples collected in the sample collection channel, and the sample container is operated for fluid communication with the collection channel. The container is capable of engaging and when fluid communication is established, the container transfers a second motive force, which is different from the first motive force, from the channel into the sample container for most of the fluid sample. Provide for. The sample container may be arranged so that mixing between the fluid sample and the container does not occur. This device is used to collect blood or other body fluids. Intravenous blood collection is relatively rapid, but may require a longer time period to obtain the desired amount of sample to be used for non-venous blood collection, and the channel. Early introduction of a substance, such as an anticoagulant, that can be coated can prevent premature coagulation of the channel during collection.

In another embodiment described herein, a device for collecting body fluid samples is provided. The instrument includes a first portion that includes a plurality of sample collection channels, at least two of the channels simultaneously providing fluid samples to each of the at least two sample collection channels via a first type of driving force. It is configured to be pulled out. The device may also include a second portion containing a plurality of sample containers for receiving body fluid samples collected in the sample collection channel, wherein the sample container is a fluid with which the sample container is in contact with the sample collection channel. It can have a first state that is not in the connection, and can also have a second state that is engageable because the sample vessel is operably in fluid communication with the collection channel, establishing fluid communication. Immediately, the sample vessel provides a second motive force that is different from the first motive force for moving the fluid sample from the channel into the sample vessel. In embodiments, the driving forces for the movement of body fluids are capillary action, decompression (eg, a vacuum or partial vacuum that draws the fluid into a site with decompression), pressurization (eg, forcing a fluid from the section with pressurization). Can include substances that evacuate fluid by capillary action, or are derived from other means.

In a further embodiment described herein, at least two samples configured to simultaneously draw a fluid sample into each of at least two sample collection channels via a first type of driving force. By using a sample collection device having a collection channel, a method is provided in which a minimum amount of sample is calibrated and placed in at least two channels. After confirming that the desired amount of sample fluid is in the collection channel, fluid communication is established between the sample collection channel and the sample container, and the fluid sample is moved from the channel into the container. The container provides a second driving force that is different from the first driving force for collecting the sample. In some alternative embodiments, devices that use only a single channel for collecting body fluids, or devices that have multiple channels but do not collect them at the same time are not excluded. Optionally, sample fluid collection is carried out without the use of substances that are capillarically absorbed.

In one embodiment, there is a separate time between sample collection and introduction of the sample into the sample pretreatment equipment. In one non-limiting example, the process is a discontinuous process. The sample collection occurs at one processing station and then the sample is transported to a second station. This second station may be in the building with the sample. Optionally, the second station will allow the sample to be carried on foot, by driving, by flight, by conveyor, or by transport to reach a second location. It may be in another location that needs to be placed on the equipment or placed on the shipping container. In this way, there are separate breaks in the process to allow the time associated with sample transport.

In another embodiment of the specification, a separation gel that separates cells, or other solid or semi-solid parts, from the whole blood cell-free fraction of the sample is the sample. Can be contained in a container. Such gels or other separating materials may be included in the sample container before, during, or after the sample is introduced into the sample container. The separating material comprises the composition of cells and solution so that the sample constituents can be separated by allowing the material to flow to a position between the solution and the non-solution sample layer during separation such as centrifugation. It can have a specific weight between the elements. Following centrifugation, the separating material ceases to flow and remains a soft barrier between the layers. In some embodiments, the separating material can be further processed to cure to a more rigid barrier. In one non-limiting example, the separating material is a UV curable material, such as, but not limited to, a shake-denaturing gel of a sorbitol-based gelling agent in a diacrylate oligomer. The sample container may have a complete container or optionally cure a UV curable material that has been exposed to UV light for 10 to 30 seconds, etc., to cure the material. Have in that part. Such curing may involve cross-linking of the material in a UV curable material. Optionally, the UV curable material can be used in conjunction with conventional separation gel materials such that only one side (solution side or solid side) can come into contact with the UV curable material. Optionally, the UV curable material can be used with a third material so that the UV curable material is between the two separating materials and does not come into direct contact with the solution and non-solution portion of the sample.

Samples of body fluids can be collected by the devices disclosed and described herein. Methods for collecting body fluids using these devices are disclosed and described herein. Samples of body fluids, such as those collected by the devices and / or methods disclosed and described herein, can be transported from the sample collection site to one or more other sites.

At least one embodiment described herein provides a method of physically transporting a small volume of body fluid in the form of a liquid from one location to another. As an unrestricted example, the sample is collected in liquid form at the collection site, transported in liquid form, and arrives at the analysis site in liquid form. In many embodiments, the form of the liquid during transport prevents the porous matrix, capillarity-absorbing material, reticulated material, or sample from being extracted at the destination site as well. Not retained by the substance. In one embodiment, the small volume of the sample in each sample container ranges from about 1 ml to about 500 microliters. Optionally, the small volume ranges from about 500 microliters to about 250 microliters. Optionally, the small volume is from about 250 microliters to about 100 microliters. Optionally, the small volume is in the range of about 100 microliters to about 50 microliters. Optionally, the small volume is in the range of about 80 microliters to about 40 microliters. Optionally, the small volume ranges from about 40 microliters to about 1 microliter. Optionally, the small volume is in the range of about 1 microliter to about 0.3 microliter. Optionally, the small volume is in the range of about 0.3 microliters or less.

The shipping container disclosed and described herein may include components configured to receive and hold the sample container. In embodiments, the components configured to receive and hold the sample container may be configured to receive and hold multiple sample containers. In embodiments, such components may include, for example, a flat sheet such as a dish. In embodiments, such components (eg, flat sheets) may include openings with an inner surface configured to receive the sample container (eg, slots, apertures or receptacles). In an embodiment, the shipping container may include a plurality of openings (eg, slots, apertures or receptacles), each containing a component having an inner surface configured to receive a sample container. In embodiments, such an inner surface can be at least partially complementary to the outer surface of the sample container, or a portion thereof.

In another embodiment described herein, the shipping vessel can provide a high density sample vessel per unit area in a fixed fashion during transport, but at the destination location. Can be removed. In one non-limiting example, the sample containers are arranged in an array with at least 6 sample containers per square inch when the array is viewed from top to bottom. Optionally, when looking at the array from top to bottom, there are at least eight sample containers per square inch. Optionally, use a large bag with at least 10 sample containers per square inch when the array is viewed from top to bottom, in which the sample containers are free to move in an unconstrained manner. In some embodiments, the shipping vessels place a particular sample container, such as from the same subject, into an adjacent sample container so that they can be visually identified as being from a common subject. On the other hand, they may be held close to each other with respect to the horizontal or other spacing. Optionally, the shipping container has an opening for receiving a carrier that holds one or more sample containers together, and those containers have common features, such as, but not limited to, from the same subject. Have.

In embodiments, the sample container is adapted to help maintain the sample in liquid form. In an embodiment, the sample is processed in a sample container prior to arrival in a manner adapted to keep the sample in liquid form. For example, the sample container can contain an anticoagulant, or the sample can be treated with an anticoagulant before or during transporting or placing the sample in the sample container. In embodiments, the anticoagulant may be selected from the group consisting of heparin (eg, lithium heparin or sodium heparin), ethylenediaminetetraacetic acid, 4-hydroxycoumarin, vitamin K antagonist (VKA) or other additives. it can. In addition to the high density per unit area, some embodiments of the shipping vessel also include highly diverse samples, such as samples from multiple different subjects. As a non-limiting example, the shipping container is packed until all available openings in the shipping container are filled, such as four samples from one subject and two samples from another subject. be able to.

Each of the samples can have a separate destination for individually selected analysis, and in at least one embodiment, it will not be grouped into the shipping vessel based on the tests performed. I want to be understood. As a non-limiting example, not all of the shipping container samples are collected for the same inspection. Traditional inspection systems can only be grouped together for the transport of those samples that have destinations for exactly the same inspection. In at least one of the embodiments herein, there is a variety of samples, each of which can be allocated for one's own set of tests. In such an embodiment, the grouping within the shipping container is not limited to samples targeting the same inspection. This further simplifies sample processing because sample transport does not need to be further isolated based on the tests performed. Some embodiments of the shipping container include samples from at least 3 or more different patients. Some embodiments of the shipping container include samples from at least 5 or more different patients. Some embodiments of the shipping container include samples from at least 10 or more different patients. Some embodiments of the shipping container include samples from at least 20 different patients.

As a non-limiting example, one embodiment described herein may optionally use a tray with a slot for holding the sample container and / or sample container holder. In one embodiment, the tray can be doubled as a holding device while waiting for more samples or being stored in a cooling chamber while waiting for transport. In some embodiments, the tray can be removed from the shipping container, so in one embodiment, the tray can itself be cleaned and sterilized. In some embodiments, the tray in the shipping container may be held in a manner parallel to the cover of the shipping container. Optionally, the tray may be held in the shipping container at a constant angle with respect to the shipping container. Optionally, the tray is non-removably secured to the shipping container. Optionally, the tray is formed integrally with the transport container itself. Optionally, multiple trays of the same or different sizes or configurations may be placed within the shipping vessel.

Yet another embodiment described herein ships a small volume sample container with an integrated temperature control unit and / or a shipping container with a substance that provides active and / or passive cooling. A method for is provided. In one embodiment, the thermal control material can be an embedded phase change material (PCM) that, but is not limited to, maintains the temperature prior to or at a desired temperature. As a non-limiting example, the phase change material can counter temperature changes near the critical temperature at which the material undergoes a phase change. When the PCM is embedded, the container and passive cooling elements can be the same. Optionally, the transport container may use an active cooling system. Optionally, the shipping vessel active cooling system can be used to maintain and / or extend the cooling time associated with the passive cooling components. In embodiments, the shipping container can contain a substance with a high heat capacity (ie, higher compared to a substance such as a plastic or polymeric substance), and at least a portion of the shipping container for an extended period of time. During that time, it may contain the mass of such a high heat capacity material that is effective for maintaining at or near the desired temperature.

Optionally, the method comprises a single step of moving multiple sample containers from different subjects from a controlled temperature storage area to a shipping container. As a non-limiting example, this single step may simultaneously move 24 or more sample containers from a storage location to a fixed position within the shipping container. Optionally, this single step may simultaneously move 36 or more sample containers from the storage location to a fixed position within the shipping container. Optionally, this single step may simultaneously move more than 48 sample containers from the storage location to a fixed position within the shipping container. In such an embodiment, the tray is initially, but not limited to, a controlled thermal, such as a refrigerator, in which samples from various subjects are collected over time until a desired number is reached. Can be in the environment. In one such embodiment, the tray that holds the sample container in the transport container can be the same as the tray that holds the sample container in the storage area. Optionally, the tray can be the same as a holding holder that holds the sample before loading it into the shipping container. Since the same tray holding the sample container is used in the transport container, the risk of the sample being lost during transport, the risk of being left in an uncontrolled thermal environment, and the like are reduced. All of the samples are in the controlled thermal because substantially all of the sample vessels in the tray are accumulated in a controlled thermal storage area and then moved in a single step. Experience substantially the same thermal exposure while being transported from a storage area into the shipping container. Since the sample vessels are subject to substantially the same thermal exposure, less variation between samples is caused by the thermal exposure time.

Optionally, the method comprises using individually addressable sample container configurations. Optionally, groups of sample containers, such as in a common carrier, can be addressed within a given group. Optionally, even sample containers in a common carrier can be individually addressed. Although not a requirement for all embodiments herein, it can be particularly useful when loading and / or removing the sample sample container and / or sample holder from the tray.

In some embodiments, yet another container (outerbox) may be used on the outside of the shipping container to provide additional physical protection and / or thermal control capability. One or more of the shipping containers can be placed in an outer box, and the combination can be shipped from one location to the desired location. As a non-limiting example, it can be in the form of a corrugated plastic outer box, which is configured to at least partially wrap or enclose the shipping container. In an embodiment, the outer box provides thermal insulation to the shipping container enclosed therein. In some embodiments, closed cell extruded Styrofoam outer boxes may be used. Some embodiments of the outer box may be formed from heat-formed panels. In some embodiments of the outer box, grips, handles, pads, wheels, latches, supports, and / or retention, operation, safety, protection, transport, or otherwise position and orientation control, and / Alternatively, it may have useful features by accessing the contents of the outer box. Some outer box embodiments may have their own active and / or passive thermal control units. In embodiments, the outer box provides cooling and thermal insulation for one or more shipping containers enclosed therein. One or more embodiments of the outer box may be configured to house one or more shipping containers. Optionally, the container may also provide additional thermal control to the shipping container by providing the shipping container therein with a thermally controlled environment in the range of desired temperatures. Optionally, this temperature range is between about 1-10 ° C, optionally between 2-8 ° C, or between 2-6 ° C.

Yet another embodiment described herein provides a method for thermally characterizing the shipping vessel after a series of cooling cycles. As a non-limiting example, after a certain number of cycles, the shipping container can be thermally characterized to ensure that the container remains within the desired range.

Some container and / or tray embodiments may include a thermal change indicator. In one non-limiting example, the indicator is integrated into a visible surface above the shipping container, tray, and / or outer box. In one non-limiting example, thermochromic inks are used as indicators of temperature change, especially when thermal changes result in temperatures outside the desired range. In one embodiment, the indicator may be configured to change the color of the entire box and / or tray. The individual changes can be reversible or irreversible. Optionally, the indicator is placed only at a selected location on the shipping container and / or tray, not the entire container or tray.

One embodiment described herein comprises collecting a fluid sample on the subject's body surface, the collected sample being stored in one or more sample containers; at least two or more samples. Includes providing a shipping container for storing the container in a first orientation; and arranging for shipping the sample container in the shipping container from a first location to a second location. Each of the sample containers is not contained in the substance sucked up by the capillary tube or the matrix substance, and most of the body fluid sample is retained for further treatment while maintaining a form that can be removed from the sample container in a liquid state. A method is provided in which the volume of each sample in the sample container does not exceed about 2 ml and arrives at a second location. In embodiments, the amount of sample in each of the sample containers does not exceed about 1 ml, or about 500 μL, or about 250 μL, or about 100 μL, or no more than about 50 μL.

Another embodiment described herein provides a method for shipping multiple sample containers, said method: to contain at least five or more containers, each containing a capillary blood sample. Each of the sample containers comprises providing a container constructed in; and arranging to ship the sample container in the transport container from a first place to a second place, each of the sample containers being a capillary tube. Arrives at a second location, retaining most of the body fluid sample, while retaining a liquid form that can be removed from the sample container for further processing without being included in the material sucked up or matrix material. And a method is provided in which the amount of each sample in the sample container does not exceed about 2 ml. In embodiments, the amount of sample in each of the sample containers does not exceed about 1 ml, or about 500 μL, or about 250 μL, or about 100 μL, or no more than about 50 μL.

In another embodiment described herein, a method for shipping a plurality of sample containers for containing a biological sample is provided, the method: containing at least 5 or more of the sample containers. Containing that the amount of each sample in the sample container does not exceed about 2 ml; and shipping the sample container from one location to a second location. Each of the sample containers was not contained in the material sucked up by the capillary and retained most of its biological sample for further treatment while retaining a liquid form that could be removed from the sample container. And arrive at the second place. In embodiments, the amount of sample in each of the sample containers does not exceed about 1 ml, or about 500 μL, or about 250 μL, or about 100 μL, or no more than about 50 μL.

Another embodiment described herein provides a method for shipping a plurality of sample containers containing capillary blood, said method: for containing at least 5 or more sample containers. A temperature profile that comprises providing a container with a thermally controlled internal region, wherein the container keeps the internal region between 1-10 ° C and does not freeze the blood sample during transport. According to, at least one cooling surface of the container is directed to the sample container and is configured to contain the sample container in a controlled shape for controlled transmission of thermal cooling. Having a container with a thermally controlled internal region; and including shipping the container from a first place to a second place, the sample container is said to be the sample container for further processing. It arrives at a second location, retaining most of the capillary blood sample, which is liquid and not contained in the substance sucked up by the capillary, which can be removed from.

In another embodiment described herein, a method for shipping multiple blood sample containers is provided, said method configured to house more than 10 sample containers in an array. Each of the containers, including shipping containers with a thermally controlled interior, holds most of the blood sample in a free-flowing, capillary-sucked form that is not contained, and each. There is no more than about 1 mL of blood in the container, and each of the containers has at least a partially vacuum pressure interior; the sample container is the sample container at a controlled distance from the cooling surface and Retained in an array shape for alignment, there is at least one preferred thermal path from the surface to the sample.

In another embodiment described herein, a method for shipping a plurality of 1 ml or less sample containers is provided, wherein the sample is anticoagulated before the sample is transferred into the sample container. Mixing with blood; associating each of the sample containers with the subject and the required sample test panel; and a thermally controlled container containing the 1 ml or less sample container in an array-shaped arrangement. Each of the containers, including shipping, holds most of its sample in a form that is not contained in the free-flowing, capillary-sucked material, and the containers are at least two in each container, respectively. At least the first sample contains the first anticoagulant and the second sample contains the second anticoagulant in the matrix so that there is a container associated with the subject. ..

In another embodiment described herein, a) a high thermal fusion material configured to have the plurality of sample vessels in a controlled and uniform thermal profile and thermal communication with the sample vessel. Having, placed in a temperature controlled shipping container, the material does not cause freezing of the sample fluid in the sample container; b) the shipping container of the thermal profile is at least at the top of the shipping container. And placing in a cavity for the product defined by the bottom wall; c) placing the active cooling device in thermal communication with the cavity, whereby the cooling device is placed. When activated, the sorption cooling device is adapted to cool the cavity and comprises an absorbent arranged to dissipate the heat generated in the absorbent outside the cavity of the product. D) Activating the cooling equipment to initiate cooling of the cavity; e) Transporting the shipping container from one location to a second location; and f) the product from the cavity. Methods are provided that include retrieval.

Another embodiment described herein provides a method of shipping a plurality of 1 ml or less sample containers, wherein the method is: the plurality of 1 ml or less samples are stored in an array, thermally controlled. Each of the above-mentioned containers holds most of the sample in a form that is free-flowing and is not contained in the substance sucked up by the capillaries, and the container is contained in each container. At least two containers associated with each subject were placed in the matrix so that at least the first sample contained the first anticoagulant and the second sample was the second. Contains anticoagulants.

It should be understood that any embodiment of the specification may be adapted to have one or more of the following characteristics: In one non-limiting example, the body fluid sample is blood. Optionally, the fluid sample is capillary blood. Optionally, collecting the fluid sample comprises making at least one puncture in the subject to collect the fluid, not the puncture vein puncture. Optionally, collecting involves using at least one microneedle to make at least one puncture on the subject. Optionally, collecting involves using at least one lancet to make at least one puncture on the subject.

Optionally, the puncture is formed by a fingertip puncture. Optionally, the puncture is formed by puncturing the skin on the subject's forearm. It is optionally formed by piercing the skin on the limbs of the punctured subject. Optionally, the puncture is formed by puncturing the ear of at least one subject. Optionally, the surface is the subject's skin. Optionally, alternative sites other than the other finger can be targeted to obtain at least one biological sample from the subject. Optionally, a solid, non-core penetrating member can be used to release the biological sample from the subject. Optionally, other embodiments cause, but not limited to, hollow needles or other hollow penetrating members to release a liquid biological sample, and, but not limited to, a non-liquid sample such as tissue. Can be provided for both to obtain in the hollow member. Some embodiments may have at least one hollow penetrating member and at least one non-hollow penetrating member. In some embodiments, a blade can be used to form the wound. While puncture-type movements can be used, cutting-type movements can also be used. Any of these penetrating members can be configured for use on one or more of the target sites.

Optionally, the shipping container initially has an interior below atmospheric pressure. Optionally, the pressure below atmospheric pressure is at least a partial vacuum. Optionally, the interior of the transport container is at least below atmospheric pressure, at least below ambient pressure. Optionally, a pressure below the atmospheric pressure is selected to provide sufficient force to pull the desired volume of the sample into the sample vessel. Optionally, the shipping container accommodates at least five or more sample containers. Optionally, the shipping vessel ships fluid samples from a plurality of different subjects. Optionally, it is determined which test is performed on the body fluid sample therein. Optionally, the shipping container is placed in another container during shipping. Optionally, the method further comprises pretreating the sample in the sample container prior to shipping to a second location. Optionally, at least a portion of the sample can be collected and dried, such as, but not limited to, on a paper sample collector or the like. On the collector for the sample, there may be multiple "spots" for collection and then transportation on such a paper sample collection member. The dried sample can be shipped with a container with a liquid sample. Both can be encoded by at least one identifier associated with both collectors with the same identifier or the same subject.

Optionally, the transport container has an array density of sample containers of at least about 4 containers per square inch. Optionally, the cooling surface in the shipping container provides a temperature profile within the desired range for the sample container in the container. Optionally, the sample container can be individually addressed. Optionally, the method further comprises using a cooled tray to hold the sample container in the cooling chamber prior to loading the sample container into the container, and the same tray is the same. Used to hold the sample container in the container, the sample is placed in the container with a cooled tray. Optionally, the sample container is arranged such that at least two containers are in a container with sample body fluids from the same subject, and in the matrix, at least the first sample is the first anticoagulant. And the second sample contains a second anticoagulant. Optionally, said fluid sample comprises capillary blood for use in FDA-approved or FDA-certified test equipment and manipulation or laboratory-certified CLIA-certified testing. Optionally, the fluid sample comprises blood for use in FDA-approved or FDA-certified testing equipment and operations or laboratory-certified CLIA-certified testing. Optionally, a housing is provided that provides a controlled thermal profile and a high thermal fusion material that provides at least one cooling surface facing the vessel. Optionally, the hot fusion material is embedded in the material used to form the container. Optionally, a controlled thermal profile, a fusion of high heat, contains about 30% to 50% of the material used to form the vessel. Optionally, a controlled thermal profile, a fusion of high heat, contains about 10% to 30% of the material used to form the vessel. Optionally, the method further comprises a housing of a metallic material having a rest temperature below room temperature.

Optionally, the method further comprises scanning the information storage unit on each sample at the receiving site and automatically placing the container in the cartridge. Optionally, the method is to hold the sample container in an array shape when the same tray is in the refrigeration equipment before transport and in the transport vessel during transport. Further includes the use in. Optionally, the method further comprises using a tray to hold the sample container, which contains a highly thermally conductive substance. Optionally, the tray further includes a plurality of slots having a shape having a shape for holding the sample container holder in a preferred orientation. Optionally, the tray is configured to engage directly with the sample container holder. Optionally, the tray locking mechanism is used to hold the tray in the container, and the tray locking mechanism releases the tray only when a magnetic force is applied. Optionally, the method comprises maintaining the temperature range between 2 ° C and 8 ° C during transport. Optionally, the method further comprises a temperature control material that exceeds the freezing temperature but maintains below about 10 ° C. during transport. Optionally, the method comprises using a temperature threshold detector to display when the sample container reaches outside the threshold level. Optionally, the method further comprises scanning the container in the tray to determine if a processing step on the sample has not been performed; a processor to perform or re-perform the step. Is used. Optionally, the method further comprises loading the sample container into the tray in a single step, and then filling the tray into the transport container in a single step.

Optionally, the shipping vessel has a controlled thermal profile, a first surface configured to define a thermal conduction path to the hot fusion material in the shipping vessel. Optionally, the first surface is configured for direct contact with another surface cooled by a sorption cooling device. Optionally, the method comprises scanning the bar code of the sample container in the tray at the same time. Optionally, the method comprises scanning a row of barcodes in a sample container in the tray. Optionally, the method comprises scanning the barcode below the row of sample containers. Optionally, the method comprises shipping a plurality of said sample containers in reversed orientation. Optionally, said method comprises shipping a plurality of said sample containers in which blood cells and plasma are separated by a barrier substance. Optionally, the method comprises unlocking and opening the shipping container, in which at least one hinge holds the two pieces together. Optionally, the tray comprises a magnetic contact point for removing at least one of the trays from the container. Optionally, a computer-controlled end effector is used to load and / or remove the sample container from said shipping container, and a reader is attached to one or more sample containers before, during, or after removal. Obtain information from at least one information storage unit. It should be understood that the transport container is often used for transport, but when the transport container is not used for hot water, it is also used as a storage container for the tray and / or sample container. Therefore, the use of the container is not limited to transport and other suitable uses for any embodiment are not excluded.

In yet another embodiment of the specification, a heat controlled shipping vessel is provided for use in shipping a plurality of sample vessels, said shipping vessel: at least both defining a cavity, top, bottom, and so on. And including a container with side walls, at least one of the top, bottom and side walls contains phase change material; sized to fit within the cavity and configured to hold multiple sample containers. Containing a frame comprising a side wall configured to define a defined opening and contact the side wall of the sample container, the container comprises a first anticoagulant, each patient in at least a matrix. It is arranged to have a first sample with and a second sample with a second anticoagulant.

In another embodiment described herein, a heat controlled shipping container is provided for use in shipping a plurality of sample containers, said shipping container: a) accommodating a product therein. Includes a bottom wall and a bottom container portion that includes at least the first side wall that defines the cavity adapted for; b) said container that includes the top and bottom surfaces and defines the cavity of the product. Includes a top container portion adapted to bond with the bottom portion, the top container portion forms a top wall for the container; at least one of the top, bottom and sidewalls contains a phase change material.

In another embodiment described herein, a heat controlled shipping container is provided for use in shipping a plurality of sample containers, said shipping container: a) accommodating the product therein. Includes the bottom wall and bottom container portion that includes at least the first side wall that defines the cavity adapted for; b) said container that includes the top and bottom surfaces and defines the cavity of the product. Including a top container portion adapted to bond with the bottom portion, the top container portion forms a top wall for the container; c) space is provided to position the sample container in a predetermined orientation. Includes a holder for defining multiple sample containers to hold; at least one of the top, bottom and sidewalls contains a phase change material.

In another embodiment described herein, a shipping container for shipping a sample container is provided, wherein the container is: a generally rectangular floor; a general protruding from the longitudinal edge of the floor. Sides parallel to; generally parallel ends protruding from the edge of the edge of the floor and bridging both sides; matable over the sides and ends, and with them and the floor Covers that generally form a closed space; include a sample container holder that is detachably connected to the floor inside the container and is configured to define a space for holding the container. Optionally, the space-holding container is configured to hold a degassed blood collection tube with an internal volume of about 2 ml or less. In at least one embodiment, the container holding the space has, but is not limited to, an internal volume of about 1 ml or less, or about 500 μL or less, or about 250 μL or less, or about 100 μL or less, or about 50 μL or less. It is configured to hold a container such as a vaporized collection tube.

In another embodiment described herein, a heat controlled shipping container is provided for use in shipping a plurality of sample containers, said shipping container: a plurality of sample containers, at least one fixed. Includes means for holding in the oriented orientation; and means for thermally controlling the temperature of the sample container within a desired range of about 0 ° C to 10 ° C; holding the plurality of sample containers. The means for this is removable from the shipping container. Optionally, the space-retaining container is configured to hold a degassed blood collection tube with an internal volume of about 2 ml or less. In an embodiment, the space-holding container holds a degassed collection tube having an internal volume of about 1 ml or less, or about 500 μL or less, or about 250 μL or less, or about 100 μL or less, or about 50 μL or less. Is configured for.

It should be understood that some embodiments may include a kit comprising the shipping containers listed in any of the above. Optionally, the kit includes a shipping container and instructions for its use.

One embodiment described herein describes a method for providing a whole blood sample and / or a portion thereof from a sender to a recipient. In the method, the recipient is (a) a whole blood sample and / or a isolate thereof in a fluid state in a volume of about 200 microliters (μL) or less, and (b) at least a whole blood sample and / or a isolate thereof. Includes a sample container containing one or more channels containing one or more reagents for storing whole blood samples and / or one or more specimens thereof for analysis until arriving at. The precise placement of the sample container in the package, including transporting the package, results in delivery of the container to the recipient. As a non-limiting example, the transportation of the sample container may be carried out using a courier service, a delivery person, or other shipping service.

One embodiment described herein describes a method for preparing a whole blood sample for delivery to a sample processing station. The method comprises depositing a sample container with a whole blood sample in a fluid state and a volume of about 200 μL or less at a whole blood sample processing site to process the whole blood sample. The sample container can be prepared by: (a) drawing a whole blood sample from a subject with the support of a capillary channel, and (b) placing the whole blood sample in the sample container. Whole blood samples are stored in fluid state with capillary channels and / or one or more reagents contained within said sample vessel.

It should be understood that any embodiment of the specification may be adapted to have one or more of the following characteristics: As a non-limiting example, the sample can be in a semi-solid or gel state in some embodiments. This can occur after the sample has been placed in the sample container. Optionally, the delivery service is a postal delivery service. Optionally, the blood sample is taken from the subject at the point of care location. Optionally, the location of the point of care is the subject's home. Optionally, the point of care location is the location of the healthcare provider.

In another embodiment described herein, the method of processing a whole blood sample comprises receiving a sample container having a whole blood sample of about 200 μL or less at a processing station from a home delivery service, said sample container. At the processing station, the whole blood sample in fluid state is received; and at the processing station, at least one pre-analytical and / or analytical test is performed on the whole blood sample in fluid state.

It should be understood that any embodiment of the specification may be adapted to have one or more of the following characteristics: As a non-limiting example, the test has one or more steps. Optionally, the sample container is housed in a housing having one or more environmental control zones. Optionally, the housing is adapted to control the humidity of each of the environmental control zones. Optionally, the enclosure is adapted to control the pressure of each of the environmental control zones.

Yet another embodiment described herein provides a computer-executed method for queuing blood samples for processing at a processing site. The method is: (a) identifying the geolocation of a transport vessel with a blood or other body fluid sample with the help of a geolocation system with a computer processor; (b) with the help of a computer processor, said transport vessel. Estimating the delivery time to the processing site; and (c), based on the estimated delivery time, including providing a notification for the preparation work for processing the sample at the processing site.

Yet another embodiment described herein describes a method for preparing a whole blood sample for delivery to a sample processing station. The method comprises depositing a sample container with a whole blood sample in a fluid state in a delivery service to deliver the sample container to the sample processing site for processing the whole blood sample. Is prepared by (a) collecting the whole blood sample from a subject using an instrument and (b) placing the whole blood sample in the sample container.

Optionally, depositing can include picking up and / or unloading the sample container. Optionally, processing may include pre-analytical, analytical and post-analytical processing of the sample. Optionally, delivery services may include subject delivery services or third party delivery services. Optionally, the whole blood sample is stored in a fluid state, along with one or more reagents contained in the capillary channel or the sample container.

Yet another embodiment described herein provides a method for processing a whole blood sample at a processing station. The method comprises receiving a sample container with a whole blood sample from a delivery service at a processing station, wherein the sample is (a) drawing the whole blood sample from a subject using a collection device and (b). ) Prepared by placing the whole blood sample in the sample container. The method also includes performing at least one pre-analytical or analytical test on the whole blood sample at a processing station.

It should be understood that any embodiment of the specification may be adapted to have one or more of the following characteristics: As a non-limiting example, with the help of a computer processor, we provide the estimated delivery time to completion time. Optionally, the method comprises queuing the sample container for processing, depending on the estimated delivery time of the sample container to the processing site. Optionally, the geolocation information of the sample container is identified with the assistance of a communication network.

One embodiment described herein describes a method performed by a computer that provides an estimated time for completion of processing of a blood sample. The method comprises receiving information about the transport container for processing being transported to a processing station by a delivery service, wherein the transport container has a blood sample taken from a subject. The method also includes calculating the position of the blood sample in the processing queue at a processing station with the assistance of a computer processor, the expectation of which is (i) blood or other body fluid from another subject. Information about the position of the sample in the processing queue, and (ii) another sample container with blood samples from other subjects in relation to the sample container with blood samples taken from said subject. Based on information about the geographic location of. The method comprises predicting the time to process the blood sample at the processing station from delivery of the sample container to the processing station by the delivery service; and to the prediction and the processing station of the sample container. Based on the estimated delivery time, the subject or the healthcare provider associated with the subject is provided with an estimated time to process a blood sample from the subject, said estimated time. Is measured from the time the sample container is deposited in the delivery service. Optionally, the sample is transported to multiple processing stations. As used herein. It should be understood that the process should be interpreted broadly and may include pre-analytical, analytical, and / or post-analytical steps.

Yet another embodiment described herein provides a method performed by a computer to provide an estimated time to complete processing of a blood sample from a subject. The method comprises receiving information about the transportation of a shipping container for sample processing to a processing station by a delivery service, the shipping container having a blood sample taken from a subject. The method also includes calculating the position of the blood sample in the processing queue at a processing station with the assistance of a computer processor, the expectation of which is (i) blood or other body fluid from another subject. Information about the position of the sample in the processing queue, and (ii) another sample container with blood samples from other subjects in relation to the sample container with blood samples taken from said subject. Based on information about the geographic location of. The method comprises predicting the time to process the blood sample at the processing station from delivery of the sample container to the processing station by the delivery service; and to the prediction and the processing station of the sample container. Upon delivery to the processing station, based on the estimated delivery time, the processing station allocates one or more resources for processing the blood sample.

It should be understood that any embodiment of the specification may be adapted to have one or more of the following characteristics: As a non-limiting example, the shipping container has an information storage unit that allows the identification of the shipping container by the delivery service and / or the processing location. Optionally, the information storage unit is labeled with a radio frequency identification (RFID) tag. Optionally, the information storage unit is a barcode. Optionally, the information storage unit is a microchip. Optionally, the shipping vessel may include the temperature of the body fluid sample (eg, blood sample), the pressure of the sample vessel, the pH of the sample, the turbidity of the sample, the viscosity of the sample, or other properties of the sample. Includes one or more sensors for collecting one or more of. Optionally, the treatment site processes the collected body fluid samples in an on-demand format. Optionally, the shipping container includes a geolocation device to provide a location for the sample container. Optionally, the anticoagulant is selected from the group consisting of heparin, ethylenediaminetetraacetic acid, anticoagulants, or other additives. Optionally, the container retains space therein, the transport container is configured to hold a degassed blood collection tube, up to about 30% vacuum, or up to about 40% vacuum. Or degassed, having a partial vacuum of up to about 50% vacuum, or up to about 60% vacuum, or up to about 70% vacuum, or up to about 80% vacuum, or up to about 90% vacuum. It is configured to hold a sample collection tube.

In embodiments that include a first container and a second container as described herein, in certain embodiments, the internal volumes of the first container and the second container are 1000, 750, 500, respectively. 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 micro Liter or less. In embodiments that include a first container and a second container as described herein, in certain embodiments, both the internal volume of the first container and the internal volume of the second container are 1000,750. , 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3 , Or no more than 2 microliters. In embodiments that include one or more containers as described herein, in certain embodiments, the internal volume of each of the one or more containers is 1000, 750, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 microliters or less. In embodiments that include one or more containers as described herein, in certain embodiments, any internal volume of each of the one or more containers is 1000, 750, 500, 400, 300, 250, 200. , 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

In the embodiments described herein comprising a first container and a second container, each comprising a portion of a small volume bodily fluid sample, in certain embodiments, the first container is also second. Containers of 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, Does not include a portion of a small volume bodily fluid sample having a volume greater than 4, 3, or 2 microliters.

In embodiments that include a container containing a small volume of body fluid sample as described herein, in certain embodiments, the volume of the small volume of body fluid sample in the container is 500, 400, 300, 250, 200. , 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

In embodiments that include one or more containers containing body fluid samples as described herein, in certain embodiments, at least one of the one or more containers containing body fluid samples is of the internal volume of the container. Includes body fluid samples satisfying at least 99, 98, 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10, or 5%. In embodiments that include one or more containers containing body fluid samples as described herein, in certain embodiments, all of the one or more containers are at least 99,98, of the internal volume of the container. Includes body fluid samples that satisfy 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10, or 5%.

In the embodiments described herein, including a sample collection site and a sample receiving site, in the embodiment, the sample collecting site and the sample receiving site are in the same room, building, campus, or collection of buildings. possible. In embodiments, including the sample collection and sample receiving sites described herein, in embodiments, the sample collection and sample receiving sites can be in different rooms, buildings, campuses, or collections of buildings. In embodiments, the sample collection and sample receiving sites are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, It can be 50 kilometers, 100 kilometers, or 500 kilometers away. In embodiments, the sample collection and sample receiving sites are 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100. It can be kilometers, 500 kilometers, or less than 1000 kilometers away. In embodiments, the sample collection and sample receiving sites are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50km, 100km, or 500km, and 5m, 10m, 50m, 100m, 500m, 1km, 5km, 10km, 15km, 20km, 30km, 50km, 100km, It can be 500 kilometers, or less than 1000 kilometers away. In embodiments, the first location described herein may be a sample collection site, and the second location described herein may be a sample receiving site.

In the embodiments described herein, comprising a container comprising at least a portion of a small volume bodily fluid sample being transported from a sample collection site to a sample receiving site, in the embodiment, the bodily fluid sample is in said container. It can be maintained in liquid form during transport. In embodiments described herein, each comprising two or more containers transported from a sample collection site to a sample receiving site, each containing at least a portion of a small volume of body fluid sample, in the embodiment said. The body fluid sample in each of the containers can be maintained in liquid form during the transport of the container.

In embodiments described herein that include one or more containers that are transported from a sample collection site to a sample receiving site, in embodiments, the one or more containers are transported within the transport container. obtain. In the embodiments described herein, including one or more containers transported in a shipping container, in the embodiment, the one or more containers are arranged in an array in the shipping container. And the array is at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, per square inch when viewed from top to bottom. It may contain 30, 35, 40, 50, or 100 containers.

In embodiments that include the transport of one or more containers within the transport containers described herein, in embodiments, the transport containers are at least 1, 2, 3, 4, 5, 6, 7, 8, ... It may include fluid samples from 9, 10, 15, 20, 25, 30, 35, 40, 50, or 100 different subjects.

In embodiments described herein that include a container containing at least a portion of a body fluid sample, in embodiments, the container may comprise an anticoagulant. In embodiments that include two or more containers containing a portion of a body fluid sample from a subject, in embodiments, at least one or all of the containers may contain an anticoagulant. In embodiments, each contains a portion of a body fluid sample from a subject, and in two or more containers each containing an anticoagulant, the container comprises the same anticoagulant or different anticoagulants. obtain. The anticoagulant in the container can be, for example, heparin or EDTA.

In the method described herein, comprising transporting a body fluid sample in one or more containers from a sample collection site to a sample receiving site, in an embodiment, the body fluid sample is brought to the sample receiving site, said body fluid. 48 hours, 36 hours, 24 hours, 16 hours, 12 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hours, 2 hours, 60 minutes, 45 minutes after the sample was received from the subject. , 30 minutes, 20 minutes, 15 minutes, 10 minutes, or less than 5 minutes.

In embodiments described herein, the method comprising transporting at least one container from a sample collection site to a sample receiving site, said method further comprises centrifuging the container prior to transport. .. In an embodiment of the method described herein comprising transporting a plurality of containers from a sample collection site to a sample receiving site, the method comprises centrifuging the plurality of containers prior to transport. Is further included.

In an embodiment of the method described herein of transporting at least a first container from a sample collection site to a sample receiving site, at the sample receiving site and before removing the sample from the first container. The first container is inserted into a sample processing device that includes an automated fluid handling device. In the methods described herein, the method comprising transporting at least the first and second containers from the sample collection site to the sample receiving site, in embodiments, at the sample receiving site and at the first sample. The first and second containers are inserted into a sample processing device, including an automated fluid handling device, prior to removal from the container and the second container. In an embodiment, when a container containing a sample is inserted into a sample processing device that includes an automated fluid handling device, the sample can be removed from the container by the automated fluid handling device. In the embodiment, before inserting the container containing the sample into the sample processing device including the automated fluid handling device, is inserted into the cartridge, and the cartridge is then inserted into the sample processing device. The cartridge can contain at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 50, or a container containing any number of samples, such as 100 containers. The cartridge may further contain one or more reagents for performing one or more clinical tests on the sample. In embodiments, the cartridge may include all reagents required for all tests to be performed on the sample in the cartridge.

In embodiments, a portion of a portion of the bodily fluid sample in the container may be in any amount. For example, in embodiments, a portion of the body fluid sample in the first container may be a portion of the original sample in the first container or a portion of the diluted sample in the first container. In another example, in the embodiment, a portion of the body fluid sample in the second container may be a portion of the original sample in the second container or a portion of the diluted sample in the second container. ..

In embodiments, provided herein comprising transporting one or more containers, each containing at least a portion of a body fluid sample, from a sample collection site to a sample receiving site, in embodiments, any number of clinical tests. One or more steps may be performed by a portion of at least a portion of the body fluid sample in the container. For example, in the embodiment, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, One or more steps of 300, 400, 500, or 1000 or more different clinical tests can be performed by a portion of at least a portion of a body fluid sample. Each different laboratory test can use a separate portion of the body fluid sample, or in embodiments, two or more different laboratory tests can be performed by a particular portion of the body fluid sample. The different laboratory tests can be the same type, different types, or a mixture of the same and different types. The one or more containers may be, for example, a first container or a first container and a second container.

In embodiments, where fluid samples from subjects transported according to the systems or methods provided herein are used for more than one clinical test, each of the clinical tests is 50, per test. Less than 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, 0.05, or 0.01 equal amount , Undiluted body fluid samples (eg, undiluted whole blood, saliva, or urine) can be used.

In an embodiment provided herein, comprising obtaining a plurality of containers collectively containing a small volume of body fluid sample from a subject at a sample collection site, the plurality of obtained from the subject in the embodiment. The total volume of small volume body fluid samples in all of the containers is 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, Do not exceed 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

Transporting a container containing at least a portion of a body fluid sample from a sample collection site to a sample receiving site provided herein, at the sample receiving site, removing the original sample from the container, and then In embodiments that include producing a diluted sample from the original sample, in embodiments, the dilution is done step by step or sequentially. In embodiments, the diluted samples are 1000, 900, 800, 700, 600, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25. , 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or may have a total volume of less than 2 microliters. In embodiments, the diluted sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400 relative to the original sample. , 500, 1000, 5,000, 10,000, 50,000, or 100,000-fold diluted.

Transporting at least a first container and a second container, each of which comprises a portion of a small volume of body fluid sample obtained from a subject, provided herein from a sample collection site to a sample receiving site. In the embodiment including, in the sample receiving site, the original sample of the first container can be removed from the first container, and the original sample of the second container is the second. Can be removed from the container. From the original sample from the first container, a diluted sample of the first container can be produced. From the original sample from the second container, a diluted sample of the second container can be produced. The diluted sample in the first container and the diluted sample in the second container may have the same or different volumes and dilutions. In an embodiment, a plurality of different diluted samples may be made from one or both of the original sample in the first container and the original sample in the second container. The different diluted samples can be used for one or more different clinical tests, which can be of different types. In an embodiment, the diluted sample in the first container is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 20 as compared to the original sample in the first container. Can be diluted 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000, or 100,000 times, and 1000, 900, 800, 700, 600, 500. , 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or Samples having a total volume of less than 2 microliters and diluted in a second vessel are at least 2, 3, 4, 5, 6, 7, 8, compared to the original sample in the second vessel. Can be diluted 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000, or 100,000-fold, and 1000, 900. , 800, 700, 600, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6 It has a total volume of less than 5, 4, 3, or 2 microliters.

In embodiments provided herein, a container is obtained at a sample collection site, wherein the container contains a small volume of body fluid sample obtained from a subject, in embodiments, small in the container. The volume of the body fluid sample is 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, It can be less than 6, 5, 4, 3, or 2 microliters.

A container is obtained at a sample collection site provided herein, the container contains a small volume of body fluid sample obtained from a subject, and the container is transported from the sample collection site to a sample receiving site. In the embodiment including the above, in the embodiment, the small volume body fluid sample is 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, and so on. It can be divided into any number of parts, such as 70, 80, 90, 100, 200, 300, 400, 500, or 1000 different parts. The portions can be diluted to the same or varying amounts and, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, It can be used for 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, or 1000 or more different clinical tests.

In embodiments provided herein, comprising obtaining at least a container containing at least a portion of a small volume of body fluid sample from a subject at a sample collection site, in embodiments, the acquisition step is of small volume. It may involve collecting fluid samples from the subject (eg, fingertip puncture, or intravenous blood draw).

In embodiments provided herein that include performing at least a portion of a clinical test in a validation unit, in embodiments, the validation unit can be moved by a fluid handling device or the like. In embodiments that include two or more test units, in embodiments, the test units may be independently movable.

In embodiments provided herein, comprising transporting one or more containers containing body fluid samples, in some embodiments, the container is a container characteristic described herein, or. It may have any of the other containers suitable for storing body fluids. In some embodiments, the container is a body fluid sample, either by any of the instruments, or by the methods provided herein, or by other suitable techniques for filling a container with a small internal volume. Can be filled with. For example, in certain embodiments, the container to be transported according to the system or method provided herein can be filled with a syringe or pipette tip.

Optionally, at least one embodiment of the sample collection device herein can separate a single blood sample into different vessels for different pre-analytical treatments, which means via a fluid pathway in the device. , And / or can be achieved via different injection ports on the instrument.

In at least another embodiment described herein, a method of use with a body fluid sample from a subject, including the following, is provided: multiple sample containers from position 1 to position 2. Each of the sample containers contains a sample of about 500 μL or less, and each of the sample containers has an internal volume of about 600 μL or less, and the transportation of the plurality of sample containers is carried out to the transport container. Achieved by using a first frame sized to fit, the first frame each engages with at least one of the sample containers and holds the sample container in the desired orientation. Includes multiple openings dimensioned and shaped for use; obtaining data from each of the sample containers; providing multiple processing frames at said second location; data from said sample container. Is used to determine which of the processing frames receives which of the sample containers; and based on the data and sorting information provided by the sample container, the sample container is moved from the transport frame to the processing frame. To move; and to handle the processing frame to process the sample container processing frame at the same time.

Optionally, acquiring the data involves scanning multiple sample container IDs at the same time. Optionally, scanning occurs when the container is in the transport frame. Optionally, scanning involves scanning the lower surface of the shipping container. Optionally, determining which processing frame receives which of the sample containers involves referencing the data to at least one database on the server. Optionally, determining involves adapting the container ID to the subject ID. Optionally, determining involves matching the container ID with the pretreatment procedure. Optionally, at least some of the sample containers contain a sample with a first anticoagulant, and at least some of the other sample containers have a second, different anticoagulant.

In one embodiment, a method of use with a body fluid sample from a subject, the method comprising: transporting a plurality of sample containers from a first position to a second position, said. Each of the sample vessels is about 500 μL or less, but contains more than about 30 μL of body fluid sample, and each of the sample containers has an internal volume of about 600 μL or less, and the body fluid sample to form the first treated sample. To a first accelerated settling force of at least about 1400 g; transporting the first treated sample from the first position to the second position; and the first treated sample. In the second place, subject to a second accelerated settling force that exceeds about 10 g but not more than about 500 g.

Any of the embodiments herein may be configured for one or more of the following features: In one embodiment, the first treated sample comprises a first anticoagulant. Optionally, the first treated sample comprises a heparin-based anticoagulant. Optionally, the first treated sample comprises a plasma moiety separated from the formed blood component moiety by a separation gel. Optionally, the second treated sample does not drive the passage of the electrolyte separation gel from the formed blood component portion to the plasma portion. Optionally, the second treated sample does not facilitate the passage of the liquid separation gel from the formed blood component portion to the plasma portion. .. Optionally, the first accelerated sedimentation force is provided via centrifugation. Optionally, the second accelerated sedimentation force is provided via centrifugation. Optionally, multiple samples are transported from the first position to the second position, each of the samples undergoing a first accelerated settling on an independent basis, and the plurality of samples being the first. Receive the second accelerated subsidence as a group at the same time. Optionally, multiple samples in the sample container are transported from the first position to the second position and undergo the first accelerated sedimentation on an independent substrate, and the multiple samples are the second. Accelerated subsidence is simultaneously received as a group in a single tray. Optionally, multiple samples are transported from the first position to the second position, each of the samples undergoing a first accelerated sedimentation on an independent basis, and the plurality of samples are second. Accelerated sedimentation of the group is simultaneously received in at least one centrifuge tray.

Optionally, the dead volume around the sample in each of the containers containing the sample is about 60 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 50 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 40 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 30 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 20 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 10 μL or less. Optionally, at least some of the sample containers contain a sample with a first anticoagulant, and at least some of the sample containers contain a second, different anticoagulant.

Any of the embodiments herein may be configured for one or more of the following features: One embodiment comprises collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 500 microliters per vessel, but at least about 10 microliters per vessel. Exceed. Optionally, including collecting whole blood, said blood is collected in multiple vessels, less than 400 microliters per vessel, but at least about 10 microliters per vessel. Optionally, including collecting whole blood, said blood is collected in multiple vessels, less than 300 microliters per vessel, but at least about 10 microliters per vessel. Optionally, including collecting whole blood, said blood is collected in multiple vessels, less than 200 microliters per vessel, but at least about 10 microliters per vessel. Optionally, including collecting whole blood, said blood is collected in multiple vessels, less than 100 microliters per vessel, but at least about 10 microliters per vessel. Optionally, said method comprises transporting a fluid sample in a liquid from a first position to a second position. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, wherein the sample is at least 1500 g at the first location, and said second. In the place of, less than 400 g but more than 10 g, including centrifugation. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, such as, but not limited to, centrifuging the sample at the first location. Includes applying a first accelerated settling force of at least 1400 g, and applying a settling force of less than 400 g but greater than 10 g at the second location. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, such as, but not limited to, centrifuging the sample at the first location. Includes applying a first accelerated settling force of at least 1400 g, and applying a settling force of less than 500 g but greater than 10 g at the second location. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, such as, but not limited to, centrifuging the sample at the first location. The sample is from about 50 to about 200 microliters, comprising centrifuging at least 1500 g and centrifuging at the second location, less than 400 g but greater than 10 g. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, such as, but not limited to, centrifuging the sample at the first location. The sample is from about 50 to about 300 microliters, comprising centrifuging at least 1500 g and centrifuging at the second location, less than 400 g but greater than 10 g. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, such as, but not limited to, centrifuging the sample at the first location. The sample is from about 20 to about 180 microliters, comprising centrifuging at least 1500 g and centrifuging at the second location, less than 400 g but greater than 10 g. Optionally, the method comprises transporting a fluid sample in a liquid from a first position to a second position, the sample being centrifuged at at least 1500 g at the first location, and. In the second location, including centrifugation of less than 400 g but more than 10 g, the sample is from about 20 to about 200 microliters, 5 to 30 microliters when the sample is filled. It is in a vessel with a dead volume. Optionally, equipment including shipping containers is provided. Optionally, the method comprises centrifuging the sample at at least 1400 g at the first location and centrifuging at less than 500 g at the second location. Optionally, a system is provided that includes a processor programmed to determine at least the desired sample dilution for the sample and at least the desired number of equal parts.

Optionally, a method is provided that includes at least one technical feature from any of the disclosed embodiments.

Optionally, a method is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

Optionally, equipment is provided that includes at least one technical feature from any of the disclosed embodiments.

Optionally, equipment is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

Optionally, a system is provided that includes at least one technical feature from any of the disclosed embodiments.

Optionally, a system is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

This gist is provided to introduce a selection in a simplified form of the concept further described in the detailed description of the invention below. This gist is not intended to identify the main features or essential characteristics of the claimed subject matter and is not intended to be used to limit the scope of the claimed subject matter.
The present invention provides, for example,:
(Item 1)
Methods to use with body fluid samples from subjects, including:
Transporting a plurality of sample containers from a first position to a second position, wherein each of the sample containers contains a body fluid sample of about 500 μL or less but more than about 30 μL, and each of the sample containers contains a body fluid sample. The internal volume is about 600 μL or less,
The body fluid sample is subjected to a first accelerated sedimentation force of at least about 1400 g or more to form the first treated sample;
Transporting the first processed sample from the first position to the second position; and the first processed sample in the second location in excess of about 10 g but not in excess of about 500 g. Apply to accelerated settling force.
(Item 2)
The method of item 1, wherein the first treated sample comprises a first anticoagulant.
(Item 3)
The method of item 1, wherein the first treated sample comprises a heparin-based anticoagulant.
(Item 4)
The method of item 1, wherein the first treated sample comprises a plasma moiety separated by a separation gel from the formed blood component moiety.
(Item 5)
The method of item 1, wherein the second treated sample does not promote the passage of the electrolyte separation gel from the formed blood component portion to the plasma portion.
(Item 6)
The method of item 1, wherein the second treated sample does not facilitate the passage of the liquid separation gel from the formed blood component portion to the plasma portion.
(Item 7)
The method of item 1, wherein the first accelerated sedimentation force is provided via centrifugation.
(Item 8)
The method of item 1, wherein the second accelerated sedimentation force is provided via centrifugation.
(Item 9)
Multiple samples are transported from the first position to the second position, each of the samples undergoes a first accelerated sedimentation on an independent basis, and the plurality of samples are second accelerated. Item 1. The method of item 1 in which the sedimentation is simultaneously received as a group.
(Item 10)
Multiple samples in a sample container are transported from the first position to the second position and undergo a first accelerated settling on an independent substrate, and the multiple samples undergo a second accelerated settling, the second accelerated settling. Item 1 method to receive at the same time in a single tray as a group.
(Item 11)
Multiple samples, each contained within one of a plurality of sample containers, are transported from the first position to the second position, and each of the samples undergoes a first accelerated sedimentation on an independent basis. And the method of item 1, wherein the plurality of samples simultaneously undergo a second accelerated sedimentation in at least one centrifuge tray as a group.
(Item 12)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 60 μL or less.
(Item 13)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 50 μL or less.
(Item 14)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 40 μL or less.
(Item 15)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 30 μL or less.
(Item 16)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 20 μL or less.
(Item 17)
Item 11. The method of item 11, wherein the dead volume around the sample in each of the containers containing the sample is about 10 μL or less.
(Item 18)
Item 11. The method of item 11, further comprising obtaining data from the sample container by scanning the plurality of sample container IDs at the same time.
(Item 19)
Item 18. The method of item 18, wherein the scanning occurs while the container is in the transport frame.
(Item 20)
Item 18. The method of item 18, wherein the scanning comprises scanning the lower surface of the shipping container.
(Item 21)
The method of item 1, wherein at least some of the sample containers contain a sample having a first anticoagulant, and at least some of the sample containers contain a second, different anticoagulant.
(Item 22)
A method comprising collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 500 microliters per vessel, but at least about 10 microliters per vessel.
(Item 23)
A method comprising collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 400 microliters per vessel, but at least about 10 microliters per vessel.
(Item 24)
A method comprising collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 300 microliters per vessel, but at least about 10 microliters per vessel.
(Item 25)
A method comprising collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 200 microliters per vessel, but at least about 10 microliters per vessel.
(Item 26)
A method comprising collecting capillary blood from a subject, wherein the blood is collected in multiple vessels, less than 100 microliters per vessel, but at least about 10 microliters per vessel.
(Item 27)
A method comprising transporting a fluid sample in a liquid from a first position to a second position.
(Item 28)
Including transporting a fluid sample in a liquid from a first position to a second position, the sample is at least 1500 g at the first location and less than 400 g at the second location. A method comprising centrifuging, which weighs more than 10 g.
(Item 29)
Including transporting a fluid sample in a liquid from a first position to a second position, the sample is at least 1400 g at the first location and less than 500 g at the second location. A method comprising centrifuging, which weighs more than 10 g.
(Item 30)
It comprises transporting a fluid sample in a liquid from a first position to a second position, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. A method in which the sample is from about 50 to about 200 microliters, comprising centrifuging in excess of 10 g.
(Item 31)
It comprises transporting a fluid sample in a liquid from a first position to a second position, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. A method in which the sample is from about 50 to about 300 microliters, comprising centrifuging in excess of 10 g.
(Item 32)
It comprises transporting a fluid sample in a liquid from a first position to a second position, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. A method in which the sample is from about 20 to about 180 microliters, comprising centrifuging in excess of 10 g.
(Item 33)
It comprises transporting a fluid sample in a liquid from a first position to a second position, wherein the sample is at least 1500 g in the first place and less than 400 g in the second place. A method in which the sample is about 20 to about 180 microliters and has a dead volume of 5 to 30 microliters when the sample is filled, comprising centrifuging to greater than 10 g.
(Item 34)
Equipment including shipping containers.
(Item 35)
Containing the transport of a fluid sample in a liquid from a first position to a second position, the sample is at least 1400 g at the first location and less than 500 g at the second location. Methods involving centrifugation.
(Item 36)
Equipment including shipping containers.
(Item 37)
Equipment including sample collection equipment.
(Item 38)
A system comprising a processor programmed to determine at least the desired sample dilution for a sample and at least the desired number of equal parts.
(Item 39)
A method comprising at least one technical feature from any of the above items.
(Item 40)
A method that includes any two technical features from any of the above items.
(Item 41)
A device that includes at least one technical feature from any of the above items.
(Item 42)
A device that includes any two technical features from any of the above items.
(Item 43)
A system that includes at least one technical feature from any of the above items.
(Item 44)
A system that includes any two technical features from any of the above items.

(Built-in by reference)
All publications, patents and patent applications referred to herein are indicated by reference as if each of the individual publications, patents and patent applications were incorporated by reference. To the same extent as incorporated herein by reference.

1A-1B show perspective views of a sample collection device according to one embodiment described herein.

2A-2C show perspective views of a capless sample collection device according to one embodiment described herein.

3A-3B show side views and cross-sectional views of the sample collection device according to one embodiment described herein.

4A-4B show side views and cross-sectional views of the sample collection device according to one embodiment described herein.

5A-5B show perspective views of the sample collection device according to one embodiment described herein.

6A-6B show side views of the sample collection device according to one embodiment described herein.

7A-8B show side views and cross-sectional views of a sample collection device according to one embodiment described herein. 7A-8B show side views and cross-sectional views of a sample collection device according to one embodiment described herein.

9A-9C show side sectional views of various stages of use of the sample collection device according to one embodiment described herein.

10A-10B show a perspective view of a sample collection device according to one embodiment described herein.

11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection equipment according to one embodiment described herein.

FIG. 12 shows a schematic view of the tip portion of the sleeve and the tip portion of the sleeve associated with one embodiment described herein and the balance of forces associated therewith.

13-13D show diagrams of various collection devices with upward collection locations according to the embodiments described herein. 13-13D show diagrams of various collection devices with upward collection locations according to the embodiments described herein.

14-15 show various diagrams of collection equipment having a single collection location according to one embodiment described herein. 14-15 show various diagrams of collection equipment having a single collection location according to one embodiment described herein.

16-17 show perspective views and end-views of a sample collection device having a container with an identifier according to one embodiment described herein. 16-17 show perspective views and end-views of a sample collection device having a container with an identifier according to one embodiment described herein.

18A-18G show various diagrams of sample containers according to the embodiments described herein. 18A-18G show various diagrams of sample containers according to the embodiments described herein. 18A-18G show various diagrams of sample containers according to the embodiments described herein.

19A-19C show diagrams of various embodiments of the front end face of the sample collection device.

Figures 20-21 show various embodiments of a sample collection device with an integrated tissue penetration member. Figures 20-21 show various embodiments of a sample collection device with an integrated tissue penetration member.

FIG. 22 shows a perspective view of a collection device for use with various blood vessel or other tissue penetrators and sample collectors according to the embodiments described herein.

FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein. FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein. FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein. FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein. FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein. FIGS. 23-28 show various diagrams of sample collection equipment for use with various sample collectors according to the embodiments described herein.

29A-29C show schematics of the various embodiments described herein.

30-31 are schematic views of the method according to the embodiments described herein. 30-31 are schematic views of the method according to the embodiments described herein.

FIG. 32 shows a schematic diagram of an embodiment of the system described herein.

33-37 show yet another embodiment of the collection device described herein. 33-37 show yet another embodiment of the collection device described herein. 33-37 show yet another embodiment of the collection device described herein. 33-37 show yet another embodiment of the collection device described herein. 33-37 show yet another embodiment of the collection device described herein.

38A-39 show various diagrams of thermally controlled transport container transport equipment according to at least one embodiment described herein. 38A-39 show various diagrams of thermally controlled transport container transport equipment according to at least one embodiment described herein.

40A-40C show schematic views of the various embodiments described herein. 40A-40C show schematic views of the various embodiments described herein.

FIG. 41 shows a perspective view of a portion of a shipping container having a plurality of sample containers therein, according to at least one embodiment described herein.

FIG. 42 shows an exploded perspective view of a portion of a shipping container having a plurality of sample containers therein, according to at least one embodiment described herein.

FIG. 43 shows a perspective view of a shipping container according to yet another embodiment described herein.

FIG. 44 shows a schematic diagram of a sample collection and transport process according to one embodiment described herein.

FIG. 45 shows a schematic diagram of the process of sample collection and transport according to another embodiment described herein.

FIG. 46 shows a sample collection device according to one embodiment described herein.

FIG. 47 shows a schematic diagram of a system for removing a sample container from a shipping container according to one embodiment described herein.

FIG. 48 is a graph showing the stability of a sample in a sample in a container provided herein.

FIGS. 49-51 show a non-limiting example of testing by at least one embodiment described herein. FIGS. 49-51 show a non-limiting example of testing by at least one embodiment described herein. FIGS. 49-51 show a non-limiting example of testing by at least one embodiment described herein.

52-55 show various diagrams of equipment and systems according to embodiments of this specification. 52-55 show various diagrams of equipment and systems according to embodiments of this specification. 52-55 show various diagrams of equipment and systems according to embodiments of this specification. 52-55 show various diagrams of equipment and systems according to embodiments of this specification. 52-55 show various diagrams of equipment and systems according to embodiments of this specification. 52-55 show various diagrams of equipment and systems according to embodiments of this specification.

Figures 56-59 show various diagrams of sample transport equipment according to at least some embodiments herein. Figures 56-59 show various diagrams of sample transport equipment according to at least some embodiments herein. Figures 56-59 show various diagrams of sample transport equipment according to at least some embodiments herein. Figures 56-59 show various diagrams of sample transport equipment according to at least some embodiments herein.

(Detailed description of the invention)
It should be understood that the general description above and the detailed description below are merely exemplary and descriptive and do not limit the invention as claimed. As used herein and in the appended claims, the singular forms "a (one),""an(one)," and "the (above)" are used unless expressly indicated in the context. Note that it has multiple meanings. Thus, for example, a reference to "a material" can include a mixture of substances, an "a compound" can include a plurality of compounds, and the like. The references referred to herein are incorporated herein by reference in their entirety, to the extent that they are consistent with the teachings expressly set forth herein.

References are made herein and in the claims that follow, but they are defined as having the following meanings:

"Optional" or "optionally" occurs even if this description occurs because this description can include cases where and without subsequent situations occur. It means that it does not have to be. For example, if the instrument optionally contains properties for a sample collection unit, this means that this sample collection unit may or may not be present, and therefore this description is given by the instrument. It includes both a structure with a sample collection unit and a structure without a sample collection unit.

As used herein, the term "substantial" means more than a "minimal" or "small" amount; and "substantial" means "minimum." , Or "slightly" more. Thus, for example, the phrase "substantially difference" as used herein statistically allows one of ordinary skill in the art to measure the difference between two numbers in the context of the characteristic measured by that value. It means that there is a sufficiently high degree of difference between the two numbers that can be considered significant. Thus, the difference between two values that are sufficiently different from each other, as a function of the reference or comparator values, is typically greater than about 10%, and greater than about 20%, greater than about 30%, about 40%. Can be greater than, or about 50% greater.

As used herein, a "sample" can be, but is not limited to, a blood sample, or a portion of a blood sample, of any suitable size or volume, and preferably of a small size. Or it is a volume. In some embodiments of the tests and methods disclosed herein, measurements can be made with a small volume of blood sample or a portion of the blood sample that does not exceed a small volume, with a small volume of less than about 5 mL. Includes; or contains less than about 3 mL; or contains less than about 2 mL; or contains less than about 1 mL; or contains less than about 500 μL; or contains less than about 250 μL; or contains less than about 100 μL; or contains less than about 75 μL Or contains less than about 50 μL; or contains less than about 35 μL; or contains less than about 25 μL; or contains less than about 20 μL; or contains less than about 15 μL; or contains less than about 10 μL; or contains less than about 8 μL; Or contains less than about 6 μL; or contains less than about 5 μL; or contains less than about 4 μL; or contains less than 3 μL; or contains less than about 2 μL; or contains less than about 1 μL; or contains less than about 0.8 μL; Or contains about 0.5 μL; or contains about 0.3 μL; or an contains about 0.2 μL; or contains about 0.1 μL; or contains about 0.05 μL; or contains about 0.01 μL.

As used herein, the term "point of service location" refers to a subject providing services (eg, testing, monitoring, treatment, diagnosis, guidance, sample collection, ID verification, medical services, non-medical services, etc.). Can include and without limitation the location of access, and without limitation, subject's home, subject's place of work, location of health care provider (eg, doctor), hospital, emergency room, operating room, clinic, health Care specialist offices, clinical laboratories, retail stores [eg pharmacies (eg retail pharmacies, clinical pharmacies, hospital pharmacies), drug stores, supermarkets, grocery stores, etc.], transport vehicles (eg private cars, boats, etc.) , Trucks, buses, aircraft, bikes, ambulances, mobile units, fire trucks / trucks, life ambulances, judicial vehicles, police vehicles, or vehicles that are set to move the subject from one point to another), move Medical care units, mobile units, schools, day care centers, baggage inspection areas, battlefields, health support living homes, government offices, office buildings, tents, fluid sampling facilities (eg blood collection centers), locations where subjects can access The location of the entrance to or near the entrance, the location on or near the device that the subject may want access to, the location that the subject may want access to or near (for example, if the subject wants to access the computer). The location of the computer), the location where the sample processing equipment receives the sample, or any other point of service location described elsewhere herein.

As used herein, "body fluid" (body fluid) refers to any fluid obtained or can be obtained from a subject. Body fluid refers, for example, to blood, urine, saliva, tears, sweat, body secretions, body excretion, or any fluid that originates from or is obtained from a subject. Among other things, body fluids are, without limitation, blood, serum, plasma, bone marrow, saliva, urine, gastric fluid, spinal fluid, tears, feces, mucus, sweat, ear stains, fat, glandular secretions, cerebrospinal fluid, semen, vaginal fluid. Includes interstitial fluid, ophthalmic fluid, placental fluid, amniotic fluid, umbilical fluid, lymph, cavity fluid, sputum, pus, fetal stool, breast milk and / or other secretions or excretions derived from tumor tissue. ..

The "body fluid sample collector" or any other collection mechanism used herein can be disposable. For example, fluid collectors can be used once and discarded. The fluid collector has one or more disposable components. Alternatively, the fluid collector may be reusable. The fluid collector can be reused any number of times. In some cases, the fluid collector may contain both reusable and disposable components.

As used herein, the "sample collection unit" and / or any part of the instrument is capable of receiving a single type of sample, or multiple types of sample. For example, the sample collection unit is capable of receiving two different types of body fluids (eg, blood, tears). In another example, the sample collection unit is capable of receiving two different types of biological samples (eg, urine sample, fecal sample). Multiple types of samples may or may not be fluid, solid, and / or semi-solid. For example, the sample collection unit is capable of receiving one or more, two or more, or three or more of body fluids, secretions and / or tissue samples.

As used herein, the term "non-wicked, non-matrixed form" as used herein refers to whether a liquid or suspension changes form of the liquid or suspension. , Or webbing, meshes, fiber pads, absorbent substances, absorbent structures, fiber permeation networks, etc. that capture the components in the sample, the integrity of the sample in liquid form has been altered, and said sample. However, it means that it cannot be absorbed or drawn in to the extent that it cannot be extracted in liquid form while maintaining the integrity of the sample for sample analysis.

As used herein, the term "sample handling system" is used to assist in imaging, detecting, positioning, repositioning, holding, sucking, and depositing samples. Refers to a configured device or system. In one embodiment, a robot capable of pipetting is a sample handling system. In another embodiment, a pipette is a sample handling system that may or may not have (other) robotic capabilities. Samples processed by the sample handling system may or may not contain fluid. Sampling handling systems may have the ability to transport body fluids, secretions, or tissues. The sampling handling system may transport one or more substances that do not need to be samples in the instrument. For example, the sample handling system can transport powders that can react with one or more samples. In some cases, the sample handling system is a fluid handling system. The fluid handling system may include pumps and various types of valves or pipettes which may include, but are not limited to, positive displacement pipettes, air replacement pipettes and suction pipettes. The sample handling system can transport samples or other substances with the help of robots described elsewhere herein.

As used herein, the term "healthcare provider" refers to a physician or other healthcare professional who provides a subject with medical treatment and / or medical advice. A health care professional may include a person or entity associated with the health care system. Examples of healthcare professionals are physicians (including practitioners and specialists), surgeons, dentists, audiologists, medical language auditors, physician assistants, nurses, midwives, pharmacists, nutritionists, therapists, psychologists, Chiropractors, clinic staff, physiotherapists, blood collectors, occupational therapists, ophthalmologists, emergency medical technicians, emergency medical personnel, medical examination technicians, medical prosthetic technicians, X-ray technicians, social workers, and a wide variety May include other human resources trained to provide certain types of health care services. Healthcare professionals may or may not be qualified to write a prescription. Healthcare professionals may work or belong to hospitals, health care locations and other service delivery points, or may be academically trained at the same time, or may be in research and management. Certain health care professionals can provide care and treatment services for patients in private or public residences, community centers, meetinghouses or mobile units. Community health care workers may work outside of formal health care facilities. Healthcare service managers, medical records and health information engineers, and other support personnel may also be health care professionals or be attached to health care providers. Healthcare professionals can be individuals or institutions that provide prophylactic, therapeutic, enlightening, or rehabilitation health care services to individuals, families, or communities.

In some embodiments, the "healthcare provider" may already be familiar with or communicate with the subject. The subject may be a patient of the health care professional. In some cases, the health care professional may prescribe the subject for clinical examination. The health care professional may instruct or suggest undergoing a clinical examination performed at a point of service location or clinical laboratory. In one example, the health care professional may be the subject's family physician. The health care specialist may be selected or connected to the subject by any type of physician (general practitioner, referred practitioner or attending physician of the patient, optionally via telemedicine services, and / or specialist). ) May be. The health care professional can be a medical care specialist.

As used herein, the term "rack" refers to a frame or enclosure for mounting multiple modules. The rack is configured to allow the module to be fastened or engaged with the rack. In some cases, various dimensions of the rack are standardized. In one embodiment, the spacing between the modules is at least about 0.5 inch, or 1 inch, or 2 inch, or 3 inch, or 4 inch, or 5 inch, or 6 inch, or 7 inch, or 8 inch. , Or 9 inches, or 10 inches, or 11 inches, or a multiple of 12 inches.

As used in the context of biological samples, the term "cell" is not limited to, but is limited to, substances bound to small capsules (such as liposomes), cells, viral particles, and small particles such as beads, nanoparticles, or microspheres. Includes samples of generally similar size to individual cells containing. Properties include, but are not limited to: size; shape; temporal and dynamic changes such as cell motility or proliferation; granular; whether the cell membrane is complete; internal cell contents, Not limited, but not limited to, protein contents, protein modifications, nucleic acid contents, nucleic acid modifications, organella contents, nuclear structures, nuclear contents, internal cell structures, internal capsule contents, ion concentrations, and steroids or drugs. Presence of small molecules; and cell surface (both cell membrane and wall) markers containing proteins, lipids, carbohydrates, and their modifications.

As used herein, "sample" refers to the whole or any part of the original sample, unless the context explicitly indicates otherwise.

The present invention provides systems and methods for multipurpose analysis of samples or health parameters. The sample is collected and one or more sample preparation steps, assay steps, and / or detection steps can occur on the instrument. The various aspects of the invention described herein can be applied to any of the particular applications, systems, and devices described herein. The present invention may be applied as a stand-alone system or method, or as part of an integrated system such as a system that includes point-of-service healthcare. In some embodiments, the system may include externally oriented imaging techniques such as ultrasound or MRI, or external peripherals for integrated imaging and other health examinations or services. Can be integrated into. It should be understood that different aspects of the invention are recognized and practiced individually, collectively or in combination with each other.

An embodiment 100 of a sample collecting device will be described with reference to FIGS. 1A to 1B. In this non-limiting example, the sample collection device 100 may include a collection device body 120, a support 130, and a base 140. In some cases, cap 110 may be provided at will. In one embodiment, the cap can be used to cover the bloody tip after collection, to protect the opening, to keep it clean. Optionally or optionally, the cap can also be used to limit the flow rate while moving the sample fluid to the sample vessel by controlling the amount of perforations provided in the capillaries. Some embodiments may include a ventilation path (permanently open or operably closed) in the cap, while others do not. Optionally, the collection device body 120 has, but is not limited to, a first portion of said device having one or more collection paths, such as collection channels 122a, 122b, having the ability to accept sample B. Can include 100. FIG. 1A shows that sample B merely partially fills channels 122a, 122b, although partial filling is not excluded in some alternative embodiments, but in most embodiments the channels are It should be understood that when the filling process is complete, it will be completely filled with sample B. In this embodiment, the base 140 is one or more filling measuring instruments 142a, such as, but not limited to, an optical measuring instrument that can indicate whether a sample has reached one or more containers housed in the base. , 142b. This display can be by means of visible display, but it should be understood that sound, vibration, or other display methods may be used in place of or in combination with said display methods. The instrument can be on at least one container. There can be variations and alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

Although not shown for ease of illustration, the support 130 may also include one or more filling measuring instruments that indicate whether the desired filling level has been reached in the channels 122a and 122b. It can be used in place of or in combination with the filling measuring instruments 142a, 142b. Of course, the filling measuring instrument of the one or more paths can be arranged in other parts, and is not limited to being present on the support 130. This indication of the filling level in one or more of the channels 122a and 122b is by means of visible indication, but sound, vibration, etc., or other indication methods, in place of or in combination with the indication method. Please understand that it can be used. The instrument can be on at least one of the collection paths. Optionally, the instrument can be on all collection paths.

In this embodiment, the support 130 can be used to bond to the body 120, and the base 140 is used to form an integrated device. Although the device body 120, the support 130, and the base 140 are described as separate parts, one or more of those parts are integrally formed and herein for simplification of manufacturing. Now, please understand that such integration is not excluded.

In some embodiments herein, the cap 110 may optionally be provided. In one non-limiting embodiment, the cap may be fitted onto a portion of the collector body 120. The cap 110 may be removable from the collecting device body 120. In some cases, the cap 110 can be completely separated from the collection device body 120, or is, but is not limited to, hinged or otherwise coupled to the collection device. The part connected to the main body can be held. The cap 110 can cover a portion of the collector body 120 that includes an exposed end of one or more channels therein. The cap 110 prevents objects such as air, fluids, or microparticles from entering the channel within the device body when the cap is in place. Optionally, the cap 110 can be attached to the collection body 120 using any technique well known in the art or developed at a later date. For example, the cap is snap-fitted, twisted-fitted, friction-fitted, slammed, has a magnetic portion, tied, utilizes an elastic portion, and / or removably collects. Can be coupled to the device body. The cap may form a liquidtight seal with the body of the collection device. The cap can be formed from an opaque, transparent or translucent material.

In one embodiment, the collection device body 120 of the sample collection device may include at least one, but not limited to, a portion of the collection path, such as channels 122a, 122b, within it. It should be understood that non-channel collection channels are not excluded. The collector body may be coupled to a support 130, which may include one or more channel portions therein. The collecting device body may be permanently fixed to the support or removable with respect to the support. In some cases, the collector body and the support may be formed as a single integrated piece. Alternatively, the collector body and support can be formed as separate pieces. During the operation of the device, the collecting device and the support do not move relative to each other.

Optionally, the collector body 120 may be formed entirely or partially of an optically permeable material. For example, the collector body can be formed from a transparent or translucent material. Optionally, only selected parts of the body may be transparent or translucent to visualize the fluid collection channel. Optionally, the body contains an opaque material, but openings and / or windows may be formed in the body to indicate the filling level within it. The collecting device body allows the user to see the channels 122a, 122b in and / or passing through the device body. The channel may be formed of a transparent or translucent material that allows the user to see if sample B has moved through the channel. The channels can have substantially the same length. In some cases, the support 130 may be formed of an opaque material, a transparent material, or a translucent material. The support may or may not have the same optical properties as the collector body. The support may be formed from a substance different from the collection device body or from the same substance as the collection device body.

The collecting device body 120 may have any shape or size. In some embodiments, the collector body has a circular, oval, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. obtain. The shape of the cross section may remain the same or vary along the length of the collector body. In some cases, the collection device body is about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.8 cm ² , 0. It can have a cross-sectional area of 5 cm ² , 0.3 cm ² , or 0.1 cm ^{2 or less.} The cross-sectional area may remain the same or vary along the length of the collector body 120. The collecting device body may have a length of about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm or less. The collecting device body 120 can have a length larger or smaller than the cap, support, or base, or can have a length equal to the cap, support, or base. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

In one embodiment, the collection path, such as, but not limited to, channels 122a, 122b, may have the shape of the selected cross section. Some embodiments of the channel may have the same cross-sectional shape along the overall length of the channel. Optionally, the shape of the cross section may remain the same or change along the length. For example, some embodiments may have one shape at one position and may have different shapes at one or more different positions along the channel. Some embodiments may have one channel with one cross-sectional shape and at least one other channel with different cross-sectional shapes. As a non-limiting example, some may have oval, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The shape of the cross section can be the same or variable with respect to the body, support, and base. In some embodiments, the shape may be selected to maximize the volume of liquid that can be retained in the channel at a particular channel width and / or height. Some have one of the channels 122a, 122b having one cross-sectional shape, while another channel has a different cross-sectional shape. In one embodiment, the shape of the cross section of the channel can help maximize the demand within it, but optionally can also optimize the capillary tensile force on the blood. This allows for maximum filling rate. It should be understood that in some embodiments, the shape of the cross section of the channel directly affects the capillary force. As a non-limiting example, a constant volume of sample can be housed in a shallow but wide channel, or a rounded channel, both containing the same volume, but one filling rate relative to the other. , The possibility of air uptake is low, or it may be desirable in terms of factors related to the performance of the channel.

The channel can have any shape or size, but some embodiments are configured to be capable of exhibiting capillary action while the channel is in contact with the sample fluid. In some cases, the channels are approximately 10 mm ² , 7 mm ² , 5 mm ² , 4 mm ² , 3 mm ² , 2.5 mm ² , 2 mm ² , 1.5 mm ² , 1 mm ² , 0.8 mm ² , 0.5 mm ^2. , 0.3 mm ^2, or 0.1 mm ² may have the following cross-sectional area. The size of the cross section can remain the same or vary along the length. Some embodiments can be adjusted along a particular length for greater force and then for less force at different lengths. Along the length, the shape of the cross section can remain the same or change. Some channels are straight in shape. Some embodiments may have only curved or other shaped path shapes, or in combination with straight sections. Some may have different orientations within the device body 120. For example, if the device is held substantially horizontal, one or more channels will not tilt downwards, tilt upwards, or tilt at all while removing fluid from the first collection point on the instrument. be able to.

The channels 122a, 122b may be supported by the device body 120 and / or the support 130. In some cases, the overall length of the channel may be included in the combination of the instrument body and the support. In some cases, a portion of the channel can be within the instrument body, and a portion of the channel can be within the support. The position of the channel may be fixed by the device body and / or the support. In some embodiments, the channel can be defined as a lumen within a hollow needle. In some embodiments, the channel is defined simply for three sides and at least one side is open. Optionally, a cover layer separated from the body may define the sides, which are otherwise open. Some embodiments may define different aspects of said channel with different substances. All of these materials may be provided by the body, or they may be provided by a different piece of the collection device. In some embodiments, all of the channels may be coplanar. Optionally, some may have shapes that incorporate at least a portion of the channel in different planes and / or orientations. Optionally, some channels can presupposely be in different planes and / or orientations.

In some cases, multiple channels may be provided. In some embodiments, one channel branches into two or more channels. Optionally, some channels branch into a larger number of channels. Some channels may include, but are not limited to, control mechanisms such as valves for directing flow to said channel. At least a portion of the channel can be substantially parallel to each other. Alternatively, none of the channels need to be parallel to each other. In some cases, at least a portion of the channel is not parallel to each other. Optionally, the channel can be slightly curved. Optionally, the channel may have one cross-sectional area at one position and a smaller cross-sectional area at different positions along the channel. Optionally, the channel may have one cross-sectional area at one position and a larger cross-sectional area at different positions along the channel. For some embodiments of the Y-shaped design, the channels are arranged to properly define the sample for each vial so that the sample is not pulled or cross-contaminated from other channels. It may be desirable to have vents that have been made. As a non-limiting example, one embodiment with vents is shown in FIG. 11I.

The base 140 may be provided within the sample collection device. The base may be attached to the support 130. In some cases, a portion of the base may be insertable into the support and / or a portion of the support may be insertable into the base. The base may have the ability to move relative to the support. In some cases, the sample collection device may have a vertical axis extending along the length of the sample collection device. The base and / or support may move with each other in the direction of the vertical axis. The base and / or support may travel a limited distance to each other. Alternatively, the base may be secured to the support. The base may be provided at an end opposite to the end of the sample collection device, including the cap 110 of the sample collection device. Optionally, some embodiments may include an integrated base / container portion so that there is no longer a separate container assembled within the piece of said base. There can be variations and alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

The base 140 may contain one or more containers therein. The vessel can be in fluid communication with the channel and / or can be brought into a fluid communication state with the channel. The termination of the channel can be in the vessel or can be brought into the vessel. The base may include one or more optical instruments 142a, 142b that may provide a visible indication of the arrival of a sample in one or more containers housed within said base. In some embodiments, the optical measuring instrument can be an optical window that allows the user to see the interior of the base. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening that has no substance in it. The optical window may allow direct visibility of the container within the base. The container within the base may be formed from a transparent and / or translucent material that allows the user to see if the sample has reached the container at the base. For example, if blood reaches a container via the channel, the container may visually display the blood in it. In other embodiments, the optical instrument may include other properties that indicate that the container has been filled. For example, one or more sensors that can determine if a sufficient amount of sample has been filled in the container may be provided in the base or container. The one or more sensors may signal an optical instrument on the base of whether the sample was provided to the container and / or a certain amount of the sample was provided to the container. For example, the optical measuring instrument may provide a display, but not limited to, an LCD display, an optical display (eg, an LED display), a plasma screen display, etc., which may provide an indication that the container is fully filled. May include. In an alternative embodiment, an optical instrument is not required, but is not limited to, an alternative instrument, such as a voice instrument or a temperature controlled instrument, is filled when the container is filled. Can be provided to display the optics.

2A-2C provide a diagram of the sample collection device 200 without the cap 110. The sample collection device 200 may include a body 220, a support 230, and a base 240. The body can be attached to the support. In this embodiment, the base 240 may be attached to the support at an end opposite to the end that is attached to the body. The body may support and / or include at least one, two, or more channels 222a, 222b. The channel has the ability to receive samples 224a, 224b from the sample receiving end 226 of the instrument.

The body 220 may have a hollow portion 225 therein. Alternatively, the body can be formed from non-hollow pieces. The channels 222a and 222b can be integrally formed in the main body. For example, they can be passages through non-hollow parts of the body. The passage can be drilled through or formed using lithographic techniques. Alternatively, the channel may have a separate structure that can be supported by the body. For example, the channel can be formed from one or more tubes that can be supported by the body. In some cases, the channel can be held in place by a non-hollow portion of the body and can pass through one or more hollow portions of the body. Optionally, the body 220 may be formed from two interconnected pieces that define the channels 222a and 222b therein.

The channels 222a and 222b may include one or more features or properties referred to elsewhere herein. At least a portion of the channel can be parallel to each other. Alternatively, the channels can be at a constant angle to each other. In some embodiments, the channel may have a first end, which can be the sample receiving end 226 of the sample collecting device. The first end of the channel can be an open end capable of receiving the sample. In some embodiments, each end of the channel may be provided to the sample receiving end of the sample collection device. One, two, or more channels may have a first end at the sample receiving end of the sample collection device. Separate channels can be used to minimize the risk of cross-contamination of blood between one channel and another. Optionally, the channel can have an upside-down Y shape, starting from a common channel and bifurcating into two or more separate channels. This Y-shape can be useful in situations where contamination is not an issue. Optionally, an alternative method for the Y-shape is a straight channel and has said sample collection vessel that moves sequentially to engage the same needle from the straight channel.

In some cases, multiple channels may be provided. The ends of the channel at the sample receiving end may be close to each other. The ends of the channel at the sample receiving end may be adjacent to each other. The ends of the channel at the sample receiving end may be in contact with each other or from edge to edge or center to center of about 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, Distances of 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, or 20 mm. The channels may branch off from each other from the sample receiving end. For example, the other ends of the channel facing the end of the channel at the sample receiving end can be farther apart from each other. They can be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, or 30 mm apart from each other edge-to-edge or center-to-center.

In some embodiments, the body 220 may have an elongated shape. The body may have one or more tapered portions 228 at or near the sample receiving end 226. The sides of the body are focused at the sample receiving end. The tapered portion and / or the sample receiving end can be curved. Alternatively, an edge may be provided. A surface of a tapered portion at any angle with respect to the vertical axis of the device may be provided. For example, the tapered portion can be about 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degrees with respect to the vertical axis.

The sample receiving end 226 of the device can be in contact with the sample. The sample may be provided directly by the subject. The sample receiving edge may come into contact with the subject, or with a sample that is in contact with or being released from the subject. For example, the sample receiving edge may come into contact with a blood drop on the subject's finger. Blood can enter the channel. The blood can be transported through the channels by capillarity, pressure difference, gravity, or any other driving force. The blood can travel from the sample receiving end to the sample delivering end through the channel. The sample delivery end can have fluid communication or provide fluid communication with one or more containers housed within the base of the device. The sample can pass from the channel to the container. The sample can be driven into the vessel by pressure differences, capillarity, gravity, friction, and / or any other driving force. Optionally, the sample can also be blood introduced by a pipette, syringe or the like. FIG. 2B shows that sample B only partially fills the channels 222a and 222b, but in most embodiments, the channels are completely filled with sample B when the filling process is complete. I want to be understood.

3A-3B show examples of sample collection equipment before the channels 322a and 322b are brought into fluid communication with one or more containers 346a, 346b housed within the base 340 of the equipment. The sample collection device may include a cap 310, a body 320, a support 330, and a base 340. The body and / or support may support and / or include at least a portion of one, two, or more channels. The base may support and / or include one, two, or more containers.

In one embodiment, the body 320 and / or the support 330 may support one or more channels 322a, 322b in the sample collection device. In one embodiment, two channels are provided, but the description of a two-channel embodiment is not limited to any number of channels, such as 1, 3, 4, 5, 6, or more channels. Applicable to channels. Each of the channels may have a first end 323a, 323b, which may be provided at the sample receiving end 326 of the instrument. The first end of each channel can be open. The channel can be opened to the outside air. If the first end of the channel comes into contact with a fluid such as blood, the fluid can be withdrawn into the channel. Blood is drawn by capillarity or any other technique described elsewhere herein. The blood can travel along the length of the channel to the respective second ends 325a, 325b of the channel. The channels can be fluidly separated from each other. For example, the fluid can enter the first channel 322a via the first end 323a, pass the length of the channel, and exit the first channel at 325a. Similarly, the fluid can enter the second channel 322b via the first end 323b, pass the length of the channel, and exit the second channel at the second end 325b. The first and second channels can be fluidly separated because the fluid from the first channel does not pass through the second channel and vice versa. In some embodiments, the fluid can travel to the second end of the channel without first exiting.

The channels 322a and 322b may have a branched shape. For example, between the first ends 323a and 323b of the channel may be closer to each other than between the second ends 325a and 325b of the channel. More space may be provided between the second ends of the channel than between the first ends of the channel. The first ends of the channels may or may not touch each other. The first ends of the channels may be adjacent to each other.

The base 340 can be attached to the instrument support 330 for the sample collection. The base 340 may or may not be in direct contact with the support. During use of the device, the base may move relative to the support. In some embodiments, the base may slide longitudinally with respect to the support. In some cases, the base may slide in the longitudinal direction without rotating with respect to the support. In some cases, the base may slide coaxially without rotating with the support. In some cases, the base may rotate while moving relative to the support. A portion of the base may fit into a portion of the support and vice versa. For example, a portion of the base can be inserted into a portion of the support and / or a portion of the support can be inserted into the base. One or more stopping features may be provided in the base and / or its frame to provide a controlled degree of movement between the base and the support. This stop feature may include shelves, protrusions or grooves.

The base 340 may have the ability to support one or more containers 346a, 346b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container may be completely enclosed when the base engages the support 330. The base may have one or more notches, protrusions, grooves, or shaped features to accommodate the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position with respect to the base.

As many containers as the number of channels can be provided. For example, N channels can be provided, followed by N containers, where N is a positive integer (eg, 1, 2, 3, 4, 5, 6, 7, 8). , Or more). Each channel corresponds to its own container. In one embodiment, the sample collection device may have a first container and a second container at the same time as the first channel and the second channel, respectively. The first channel 322a can be configured to be in communication with or bring into communication with the first container 346a, and the second channel 322b is in communication with the second container 346b. Can be configured to be in a state or brought into a state of communication.

In some embodiments, each container may have a body 349a, 349b and a cap 348a, 348b. In some cases, the container body may be made of a transparent or translucent material. The container body allows the sample provided in the container body to be visible when viewed from the outside of the container. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end can be the top end of the container at the end of the container closer to one or more channels. The closed end can be the bottom end of the container, located at the end of the container farther by one or more channels. Embodiments of the various containers may be described in more detail elsewhere herein.

The base 340 may have one or more optical measuring instruments such as optical windows 342a, 342b. The optical window may be placed on the container 346a, 346b. In some cases, the optical window may be located in the container body. A single window may provide a view to a single container or multiple containers. In one embodiment, the same number of optical windows as the container may be provided. Each optical window can correspond to a different container. Both the optical window and the container can be formed of an optically permeable material that allows the user to see from the outside of the sample collection device whether the sample has reached the container.

In some embodiments, there may be optical windows of the channels 322a and 322b in which the user can observe whether the desired filling level has been reached in the channel. In some embodiments where the body 320 is completely transparent or translucent, there may be a marker or instrument pointing along the channel to note when the desired filling level has been reached.

The container can be sized to accommodate a small amount of fluid sample. In some embodiments, the container is 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 μL, 800 μL, 700 μL, 600 μL, 500 μL, 400 μL, 300 μL, 250 μL, 200 μL, 150 μL, 100 μL, 80 μL, 50 μL. , 30 μL, 25 μL, 20 μL, 10 μL, 7 μL, 5 μL, 3 μL, 2 μL, 1 μL, 750 nL, 500 nL, 250 nL, 200 nL, 150 nL, 100 nL, 50 nL, 10 nL, 5 nL, or 1 nL. The container may be configured to contain a few drops of blood, a drop of blood, or a portion of blood of a drop or so.

The container may include caps 348a, 348b. The lid may be configured to cover and fit over the open end of the container. The cap may block the open end of the container. The cap may fluidly seal the container. The cap may form a liquidtight seal with the container body. For example, the cap can be gas and / or liquid impermeable. Alternatively, the cap may allow certain gases and / or liquids to pass through. In some cases, the cap is gas permeable while liquid opaque. The cap may be opaque to the sample. For example, the cap can be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit into a portion of the container body. The cap may form a fastener with the container body. The cap may include a hem or shelf that can project over a portion of the container body. The hem or shelf may prevent the cap from slipping into the container body. In some cases, a portion of the cap may lie on the top and / or side of the container body. Any description of the container herein may be applicable in combination with the sample collection device. Optionally, some embodiments may include additional parts, such as cap holders, within the container assembly. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and the container. In one embodiment, the cap holder engages an accessory, edge, notch, or other accessory location on the outside of the container to hold the cap in place. Optionally, some embodiments may combine the functions of the cap and said cap holder in one component.

One or more engaging assemblies may be provided. The engaging assembly may include exerting components such as a channel holder 350 and / or a spring 352 or elastic material. In one embodiment, the holder 350 can continue to secure the adapter channel 354 to the support. As described elsewhere herein, the adapter channel 354 can be formed integrally with the collection channel, or it can be a stand-alone piece, a portion of the collection channel, or a container. It can be a separate element that can be a part. In one embodiment, the holder 350 can prevent the adapter channel 354 from sliding relative to the support. The holder 350 may optionally provide a support on which a force-bearing component, such as a spring, rests.

In one embodiment, the engaging assembly comprises a spring 352, each capable of exerting a force, so that the base 340 can be in an extended state when the spring is in its natural state. obtain. Space may be provided between the containers 346a, 346b and the engaging assembly when the base is in an extended state. In some cases, the second end of the channel may or may not touch the cap of the container when the base 340 is in the extended state. The second end of the channel, 325a, 325b, may be in a position that is not in fluid communication with the interior of the vessel.

The sample collection device may include any number of engaging assemblies. For example, as many engaging assemblies as the number of channels may be provided. Each channel may have an engaging assembly. For example, if a first channel and a second channel are provided, a first engaging assembly can be provided for the first channel, and for the second channel. A second engaging assembly may be provided. The same number of engaging assemblies and containers may be provided.

In one embodiment, the engaging assembly may house an adapter channel 354, such as, but not limited to, an elongated member having angled, tapered or pointed ends 327a and 327b. It should be appreciated that in some embodiments, the ends 327a and 327b are part of a needle formed separately from the channels 322a and 322b, and can then be combined with the channels 322a and 322b. The needle can be formed from the same or different material as the body that defines the channels 322a and 322b. For example, a metal can be used to form the needle, and a polymer or plastic material can be used to form the body that defines the channels 322a and 322b. Optionally, some embodiments may form the ends 327a and 327b on a member integrally formed with the channels 322a and 322b. In some cases, the second end of the channel may be configured to penetrate substances such as caps 348a, 348b of the container. In some embodiments, a portion of the adapter channel 354 can be inserted into the collection channel, or a portion of the collection channel can be inserted into the adapter channel, or both. It can be configured to align in the same plane. Optionally, some embodiments may form the adapter channel 354 integrally with the collection channel 322. FIG. 3B (and 4B) shows sample B filling the channels 122a, 122b only partially, but in most embodiments, when the filling process is complete, the channels will be populated by sample B. Please understand that it is completely filled. There can be variations and alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

4A-4B show an example of a sample collection device 40 having channels 422a and 422b in fluid communication with containers 446a and 446b in the device. The sample collection device may include a cap 410, a body 420, a support 430, and a base 440. The body and / or support may support and / or include at least a portion of one, two, or more channels. The base may support and / or include one, two, or more containers.

In one embodiment, the body 420 and / or support 430 may support one or more channels 422a, 422b in the sample collection device. For example, a first channel and a second channel may be provided. Each of the channels may have a first end 423a, 423b that may be provided to the sample receiving end 426 of the instrument. The first end of each channel can be open. The channel can be opened to the outside air. If the first end of the channel comes into contact with a fluid such as blood, the fluid can be withdrawn into the channel. Blood is drawn by capillarity or any other technique described elsewhere herein. The blood can travel along the length of the channel to the respective second ends 425a, 425b of the channel. In some embodiments, the fluid can reach the second end of the channel by capillary action, or any other technique described elsewhere herein. In other embodiments, the fluid does not need to reach the second end of the channel. The channels can be fluidly separated from each other.

In some embodiments, if the channel is not in fluid communication with the interior of the container 446a, 446b, the fluid can pass through to the second end of the channel without leaving. For example, the fluid can be withdrawn by capillary action that can cause the fluid to flow into or near the end of the channel without leaving the channel.

The base 440 can be attached to the instrument support 430 for the sample collection. During use of the device, the base may move relative to the support. In some embodiments, the base may slide longitudinally with respect to the support. In one embodiment, the base is compressed when (i) the channel is in fluid communication with the interior of the container and (ii) a is in fluid communication with the interior of the container. Can have a part. The sample collection device can be provided in the initially stretched state, as shown in FIG. After the sample has been collected and flowed through the length of the channel, the user pushes in the base as shown in FIG. 4 to provide the sample collecting device with its compressed state. .. Once the base has been pushed in, the base can either remain in the closet naturally or rebound to its stretched state once the pressing force is removed. In some cases, the base can be pulled out in an extended state or fully pulled out to provide access to the container within it.

The base 440 may have the ability to support one or more containers 446a, 446b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 430. The base may have one or more notches, protrusions, grooves, or shaped features to accommodate the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position with respect to the base.

As many containers as the number of channels can be provided. Each channel corresponds to its own container. In one embodiment, the sample collection device may have a first container and a second container at the same time as the first channel and the second channel, respectively. The first channel 422a can be configured to be in communication with or bring into communication with the first container 446a, and the second channel 422b is in communication with the second container 446b. Can be configured to be in a state or brought into a state of communication. The first channel may not initially be in fluid communication with the first vessel, and the second channel may not be initially in fluid communication with the second vessel. When the base is pushed against the support, the first and second channels can be brought into fluid communication with the interior of the first and second vessels, respectively. The first and second channels can be brought into fluid communication at the same time as the first and second vessels. Alternatively, they do not have to be brought into fluid communication at the same time. The timing of the fluid communication may depend on the height of the vessel and / or the length of the channel. The timing of the fluid communication may depend on the relative distance between the second end of the channel and the vessel.

In some embodiments, each container may have a body 449a, 449b and a cap 448a, 448b. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end can be the top end of the container at the end of the container closer to one or more channels. The closed end can be the bottom end of the container, located at the end of the container farther by one or more channels. Embodiments of the various containers may be described in more detail elsewhere herein.

The base 440 may have one or more optical measuring instruments such as optical windows 442a, 442b. The optical window may be placed on the container 446a, 446b. In some cases, the optical window may be located in the container body. Both the optical window and the container can be formed of an optically permeable material that allows the user to see if the sample reached the container from outside the sample collection device. In some embodiments, the container may incorporate markings on the container itself to indicate filling level requirements.

The container may include caps 448a, 448b. The cap may be configured to cover and fit over the open end of the container. The cap may block the open end of the container. The cap may fluidly seal the container. For example, the cap can be gas and / or liquid impermeable. In some cases, a portion of the cap may fit into a portion of the container body. The cap may include a hem or shelf that can project over a portion of the container body. In some embodiments, the cap may be hollow or depressed. The hollow or recess can help guide the second end of the channel to the center of the cap. In some cases, the second end of channels 425a, 425b can lie on the cap of the container when the sample collection device is in the extended state. The second end of the channel may or may not touch the cap of the container. In some cases, the second end of the channel may rest in a hollow or depressed cap. In some cases, the second end of the channel can partially penetrate the cap without reaching the inside of the container. Optionally, some embodiments of the cap may include crimp pieces to hold the vacuum.

The second end of the channel can have angled, tapered or pointed ends 427a and 427b. In some embodiments, the ends 427a and 427b are part of a needle formed separately from the channels 422a and 422b, and can then be coupled to the channels 422a and 422b. The needle can be formed from the same or different material as the body that defines the channels 422a and 422b. Optionally, some embodiments may form the ends 427a and 427b on a member integrally formed with the channels 422a and 422b. In some cases, the second end of the channel may be configured to penetrate a substance such as caps 448a, 448b of the container. The cap can be formed from a substance that can prevent the sample from passing through in the absence of the penetrating member. The cap can be formed from a single non-hollow piece. Alternatively, the cap may have a notch, an opening, a hole, a thin portion, or any other feature capable of accepting a through member. The notch or other opening can have the ability to hold the sample in the through member if it is not in the notch or opening, or if the through member is removed from the notch or opening. In some cases, the cap may be formed from a self-healing material so that when the penetrating member is removed, the opening formed by the penetrating member can be closed. The second end of the channel can be a penetrating member that passes through the cap and reaches the interior of the container. In some embodiments, it is clear that the penetrating member can be a hollow needle that allows the passage of the sample, and is not just a needle for penetrating. In some embodiments, the penetrating insert may be a non-coring design that does not remove the core from the cap material, such as, but is not limited to, a tapered cannula.

One or more engaging assemblies may be provided. The engaging assembly may include exerting components such as a channel holder 450 and / or a spring 452 or elastic material. In one embodiment, the holder 450 can continue to secure the adapter channel 454 to the support. As described elsewhere herein, the adapter channel 454 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or a container. It can be a separate element that can be a part. In one embodiment, the holder 450 may prevent the adapter channel 454 from sliding relative to the support. The holder 450 may optionally provide a support on which a force-bearing component, such as a spring, rests.

In one embodiment, the engaging assembly comprises a spring 452, each capable of exerting a force, so that the base 340 can be in an extended state when the spring is in its natural state. obtain. Space may be provided between the containers 446a, 446b and the engaging assembly when the base is in an extended state. In some cases, when the base 440 is in an extended state, the second ends 425a, 425b of the channel may be in a position that is not in fluid communication with the interior of the container.

The sample collection device may include any number of engaging assemblies. For example, as many engaging assemblies as the number of channels may be provided. Each channel may have an engaging assembly. For example, if a first channel and a second channel are provided, a first engaging assembly can be provided for the first channel, and for the second channel. A second engaging assembly may be provided. The same number of engaging assemblies and containers may be provided. In one embodiment, the same number of engaging assemblies and containers may be provided.

When the base is press-fitted, the spring 452 can be compressed. The second ends 425a and 425b of the channel may penetrate the cap of the container. The second end of the channel can enter the interior of the container. In some cases, a force may be provided to drive the fluid from the channel into the container. For example, a pressure difference can be created between the first and second ends of the channel. Positive pressure can be provided to the first end of the channel 423a, 423b and / or negative pressure can be provided to the second end of the channel. The positive pressure can be positive with respect to the second end of the channel and / or the outside air. The negative pressure can be negative with respect to the first end of the channel and / or the outside air. In one embodiment, the container may have a vacuum therein. When the second end of the channel penetrates the container, the negative pressure in the container draws the sample into the container. In an alternative embodiment, the sample can enter the container, driven by capillary force, gravity, or any other driving force. There can be variations and alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

In some cases, different types of motives may be used at different stages of sample collection. Thus, one type of motive force can be used to pull the sample into the channel, and then a different type of motive force can be used to move the sample from the channel into the container. For example, a capillary force can pull the sample into the channel, and a pressure difference can drive the sample out of the channel into the vessel. Any combination of driving forces can be used to withdraw the sample into the channel and the container. In some embodiments, the driving force for pulling a sample into the channel is different from the driving force used to pull a different sample into the container. In some alternative embodiments, the driving force is the same for each stage. In some embodiments, the driving force is applied sequentially or at defined time intervals. As a non-limiting example, no driving force for drawing a sample into said vessel is added until at least one channel reaches the minimum filling level. Optionally, no driving force for drawing the sample into the vessel is added until at least each of the two channels reaches the minimum filling level. Optionally, no driving force for drawing the sample into the vessel is applied until each of the channels of all channels reaches the minimum filling level. In some embodiments, the driving forces are applied simultaneously.

Some embodiments may use a pressurized gas source that is coupled to the sample collection device and is configured to push the collected body fluids out of one or more channels into their respective containers. Optionally, a vacuum source not associated with the vessel can be used to draw the sample fluid towards the vessel.

In some additional embodiments of the channel, once the channel is filled, there can be sufficient capillary force within it, because this force is greater than gravity, the sample , It may be configured so that it cannot escape from the channel solely on the basis of gravity. Additional motive force is used to break capillarity retention of the channel. Optionally, as described elsewhere herein, devices such as sleeves, but not limited to, can contain body fluids exiting the channel at the end closest to the container, thus. The loss to transfer to the container can be minimized.

Optionally, other substances, such as, but not limited to, lyosphere, sponge, or other motive force provider can be used to provide the motive force for pulling the sample into the container. When multiple forces are used, this is the primary, secondary, or tertiary driving force for pulling the sample into the container. Optionally, some embodiments may include, but are not limited to, a press-type motive force provider, such as a plunger, in order to move the sample in the desired manner.

Some time elapses as the sample travels along the length of the channel since it was introduced into the channel. The user can introduce the sample into the sample collection device and wait for the sample to move the length of the channel. One or more optical instruments may be provided that indicate, but not limited to, whether the sample has reached a desired filling level, such as at the end of the channel. In another embodiment, the user may wait a predetermined amount of time before pushing the base. The user determines that the sample has traveled a sufficient length of the channel and / or the base is pushed in after a sufficient amount of time has passed since the sample was introduced. After the base has been pushed in, the channel is brought into fluid communication with the vessel, and samples can flow from the channel into the vessel. An optical measuring instrument may be provided to allow the user to know when the container was filled.

As soon as the containers are filled, they can be transported to the desired location using the systems and methods described elsewhere herein. In some cases the entire sample collection device can be transported. For transport, the cap may be placed in the sample collection device. In other embodiments, the base portion and / or support portion may be removed from the rest of the device. In one embodiment, the base can be removed from the sample collection device, and the container can be transported with the base. Alternatively, the base can be removed from the sample collection device to provide access to the container, and the container is removed and delivered from the device. Removal of the base involves some disassembly of the sample collection device to separate the base. This means that to prevent accidental disengagement, a detent, but not limited to, a positive act such as disengaging a latch or other locking mechanism may be performed by the user before disengaging the base. Can be carried out by. Optionally, some embodiments may allow removal of the container without removal of the base, but by means such as an opening on the base, an access port or a cover that can be opened. Allows access to the container.

In some embodiments, the channel and / or container is one of the features described elsewhere herein, such as a separator, coating, anticoagulant, beads, or any other feature. Can include one or more. In one embodiment, the sample introduced into the sample collection device can be whole blood. Two channels and their respective containers may be provided. In this non-limiting example, each of the channels has a coating, such as, but not limited to, an anticoagulant that covers the channels. Such anticoagulant coatings can perform one or more of the following functions: First, the anticoagulant prevents whole blood from coagulating inside the channel during the sample collection process. Depending on the amount of whole blood to be collected, blood clots can prematurely occlude the channel before a sufficient amount of blood is brought into the channel. Another function is to introduce anticoagulants into whole blood samples. By having the anticoagulant in the channel, the process starts earlier in the collection process as compared to some embodiments where the anticoagulant is only in the container 446a or 446b. it can. This early introduction of the anticoagulant may cause the whole blood sample to have, but is not limited to, an portion of the needle that is bound to the channel 422a or 422b that is not covered by the anticoagulant. It can also be beneficial when guided along the path. Optionally, some embodiments may include a surfactant that can be used to modify the contact angle (wetting property) of the surface.

In some embodiments, the inner surface of the channel and / or other surfaces along the fluid path, such as, but not limited to, the sample inlet into the sample collection vessel, are surfactants and / or. Alternatively, it may be coated with an anticoagulant solution. The surfactant provides a wet surface to the hydrophobic layer of the fluid device and facilitates filling of the metering channel with a liquid sample, eg, blood. The anticoagulant solution helps prevent coagulation when the sample, eg, blood, is provided to the fluid device. Exemplary surfactants that can be used are, without limitation, Tween, TWEEN (R) 20, Thesit (R), sodium deoxycholate, Triton, Triton (R) X-100, Pluronic and / or interfaces. Other non-hemolytic detergents that provide the proper wettability properties of the activator are included. EDTA and heparin are non-limiting anticoagulants that can be used. In one non-limiting example, the solution of the embodiment contains 2% Tween, 25 mg / mLEDTA in 50% methanol / 50% water, which solution is then air dried. The methanol / water mixture provides a means of dissolving EDTA and Tween, and also dries quickly on the surface of the plastic. This solution ensures a uniform thin film, such as, for example, pipetting, spraying, printing, or wicking, on the surface coated on the channel or other surface along the fluid flow path. Can be applied using the technique of.

It should be understood that any of the embodiments herein with a coating in the channel can extend along the entire pathway of the channel. Optionally, the coating covers most, but not all, of the channels. Optionally, in some embodiments, the coating material from one channel is in contact with the target sample fluid at the same time, and thus has a connecting fluid path, via all channels to a nearby channel. To minimize the risk of transfer, cross-contamination, the channel is not covered in the region closest to the inlet opening.

Although embodiments herein are shown to have two separate channels within the sample collection device, some embodiments may use more than two separate channels. I want to be understood. Optionally, some embodiments may use less than two completely separate channels. Some embodiments may use only one separate channel. Optionally, some embodiments may use an inverted Y-shaped channel that initially starts as one channel and then branches into two or more channels. Any of these concepts may be adapted for use with other embodiments described herein.

Collection equipment with self-supporting collection channels

5A-5B provide another embodiment of the sample collection device 500 provided by the embodiments described herein. The sample collection device may include a collection device body 520, a support 530, and a base 540. In some cases, caps may be provided at will. The collection device body may include one or more collection channels 522a, 522b capable of receiving samples, defined by a collection tube. The base may include one or more optical instruments 542a, 542b that may provide a visible indication of the arrival of a sample in one or more containers housed within said base. The support may have one or more optical instruments 532a, 532b that can provide a visible indication of whether the sample has arrived or has passed a portion of said channel.

The collection device body 520 of the sample collection device includes at least a portion of one or more tubes having channels 522a and 522b therein. Optionally, the instrument collection body 520 may also define channels that connect with channels 522a and 522b defined by the tubes. In some embodiments, a portion of the channel may extend beyond the collector body. The channel may extend beyond one or two ends of the collection device body.

The collecting device body 520 may be coupled to a support 530. The collecting device body may include one or more channel portions therein. The collecting device body may be permanently fixed to the support or removable with respect to the support. In some cases, the collector body and the support may be formed as a single integrated piece. Alternatively, the collector body and support can be formed as separate pieces.

During the operation of the device, the collection device body 520 and the support 530 may move relative to each other. In some cases, a portion of the body 520 can be inserted into the support 530 and / or a portion of the support can be inserted into the body. The body may have the ability to move relative to the support. In some cases, the sample collection device may have a vertical axis extending along the length of the sample collection device. The body and / or support may move with each other in the direction of the vertical axis. The body and / or support may travel a limited distance to each other. The body and / or support can move coaxially without rotational action. Alternatively, a rotary motion may be provided.

The collector body 520 may be made of an optically permeable material. For example, the collector body can be formed from a transparent or translucent material. Alternatively, it can be formed from the body opaque material. The support 530 may be formed from an optically opaque, translucent, or transparent material. The support may or may not have the same optical properties as the collector body. The support may be formed from a substance different from the collection device body or from the same substance as the collection device body. There can be variations and alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

The collection device body, support, and / or base may have any shape or size. In some embodiments, the collector body support and / or base is circular, oval, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or optional. It may have other cross-sectional shapes. The shape of the cross section may remain the same or change along the length. In some cases, the collection device body, support, and / or base may be approximately 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ^2. , 0.8 cm ² , 0.5 cm ² , 0.3 cm ² , or 0.1 cm ² or less. The cross-sectional area may remain the same or vary along the length. The shape of the cross section can be the same or variable for the body, support, and base. In some cases, the collection device body, support, and / or base may be approximately 10 cm2, 7 cm2, 5 cm2, 4 cm2, 3 cm2, 2.5 cm2, 2 cm2, 1.5 cm2, 1 cm2, 0.8 cm2, 0.5 cm2, It can have a cross-sectional area of 0.3 cm2 or 0.1 cm2 or less. The cross-sectional area can vary with length or can remain the same. The size of the cross section can be the same or variable for the body, support, and base. The collecting device body, support, and / or base is about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm or less. Can have a length of. The collector body may have a length greater than or shorter than the support or base, or may have a length equal to the support or base.

The channels 522a, 522b can be supported by the device body 520 and / or the support 530. In some cases, the length of the tube or the entire channel within it may be included within the combination of the instrument body and the support. Alternatively, as seen in FIG. 5, the channel can extend beyond the device body and / or support. In some cases, the channel may extend beyond one end, or both ends, of the device body / support combination. In some cases, a portion of the channel can be within the instrument body and a portion of the channel can be within the support. The position of the channel may be fixed by the device body and / or the support. In some cases, the channel can be anchored to the device body and / or does not move relative to the device body. The channel can move relative to the support. In some cases, multiple channels may be provided. At least a portion of the channel is substantially parallel to each other. The channels can be parallel to each other and / or parallel to a vertical axis extending along the length of the sample collection device. Alternatively, no part of the channel need to be parallel to each other. In some cases, at least a portion of the channel is not parallel to each other. The channel can be slightly curved. Optionally, they can be very struggling, but are aligned closer as they approach the sample collection point. Sufficient for the tubes defining the channels 522a and 522b to provide a detectable change in the clear, permeable, or at least one other channel that the sample has reached the desired filling level. Please understand that it can be formed from matter. Optionally, the detectable change can be used to detect when both channels reach at least the desired filling level.

A base 540 may be provided within the sample collection device. The base may be attached to the support 530. In some cases, a portion of the base 540 can be inserted into the support 530 and / or a portion of the support can be inserted into the base. The base can be fixed to or movable with respect to the support. The base may be provided at the end of the support opposite to the end of the support coupled to the body. The base can be formed as a separate piece from the support. The base is separable from the support. Alternatively, the base can be anchored to the support and / or formed as a piece integrated with the support.

The base 540 may contain one or more containers therein. The vessel can be in fluid communication with the channel and / or can be brought into a fluid communication state with the channel. The end of the channel can be in the container or can be brought into the container. The base may include one or more optical instruments 542a, 542b that may provide a visible indication of the arrival of a sample in one or more containers housed within said base. In some embodiments, the optical measuring instrument can be an optical window that allows the user to see the interior of the base. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening that has no substance in it. The optical window may allow direct visibility of the container within the base. The container within the base may be formed from a transparent and / or translucent material that allows the user to see if the sample has reached the container at the base. For example, if blood reaches a container via the channel, the container may indicate blood in it. In other embodiments, the optical instrument may include other properties that indicate that the container has been filled. For example, one or more sensors that can determine if a sufficient amount of sample has been filled in the container may be provided in the base or container. The one or more sensors may signal an optical instrument on the base of whether the sample was provided to the container and / or a certain amount of the sample was provided to the container. For example, the optical measuring instrument may provide a display, but not limited to, an LCD display, an optical display (eg, an LED display), a plasma screen display, etc., which may provide an indication that the container is fully filled. May include. In an alternative embodiment, an optical measuring instrument need not be provided, but is not limited, when the container, such as a voice measuring instrument or a temperature controlled measuring instrument, or other device, is filled. , Alternative devices may be provided that can be displayed by detectable signals, such as those detected by the user.

The support has one or more optical instruments 532a, 532b that can provide a visible indication of whether the sample has arrived or has passed through a portion of the channel housed within said support. obtain. In some embodiments, the optical measuring instrument can be an optical window that allows the user to see inside the support. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening that has no substance in it. The optical window may allow direct visibility of the channels within the support. The channel can be formed from a transparent and / or translucent material that allows the user to see if the sample has reached a portion of the channel under the optical window. In other embodiments, the optical instrument may include other features, such as sensors described elsewhere herein, that may indicate whether the sample has passed through a portion of the channel.

With reference to FIGS. 6A-6B, additional diagrams of the sample collection device 500 according to the embodiments described herein are provided.

In some embodiments, the portion of the tube containing channels 522a and 522b may extend beyond the collector body 520. The portion of the extending channel includes a portion of the channel configured to receive a sample from a subject. In one embodiment, the channel may have a first end 523a, 523b, which can be the sample receiving end of the channel.

The channel can optionally be defined by a rigid material. Alternatively, the channel may be defined by a flexible material or may have flexible components. The channel may or may not be designed to be curved or bent. The channels may or may not be substantially parallel to each other. In some cases, the first end of the channel can be separated by some distance in the relaxed state. During the operation of the device, the first ends of the channel may remain separated from each other by the distance. Alternatively, the first ends of the channels can be brought closer to each other. For example, the first ends of the channel can be pressed against each other. Each open end of the channel may receive a sample separately. The samples can be received sequentially. The sample can be from the same subject. Alternatively, the channel may have the ability to receive the same sample at the same time.

The channels 522a and 522b may include one or more features or properties referred to elsewhere herein. At least a portion of the channel can be parallel to each other. Alternatively, the channels can be at a constant angle to each other. In some embodiments, the channel may have a first end, which may be the sample receiving end 526 of the sample collecting device. The first end of the channel can be an open end capable of receiving the sample. In some embodiments, each end of the channel may be provided to the sample receiving end of the sample collection device. One, two, or more channels may have a first end at the sample receiving end of the sample collection device.

In some embodiments, the device body 520 is movable relative to the support 530. A portion of the device body can be inserted into the support and vice versa. In one embodiment, the device body may include a rim 527 and an internal portion 529. The edge may have a larger cross-sectional area than the inner portion. The internal portion may have the ability to be inserted into the support. The edge can act as a stopper to prevent the support from being inserted into the entire body. The edge may rest on the shoulder of the support.

7A-7B show partial cutouts of an embodiment of the sample collection device 700 provided by the embodiments described herein. The sample collection device is in an stretched state prior to bringing the channels 722a, 722b into fluid communication with one or more containers 746a, 746b housed within the base 740 of the device. The sample collection device may include a body 720, a support 730, and a base 740. The body and / or support may support and / or include at least a portion of one, two or more channels. The base may support and / or include one, two or more containers. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

In one embodiment, the body 720 and / or support 730 may support one or more channels 722a, 722b of the sample collection device. In one embodiment, two channels are provided, but the description of a two-channel embodiment is not limited to any number of channels, such as 1, 3, 4, 5, 6, or more channels. Applicable to channels. The first end of each channel can be open. The channel can be opened to the outside air. If the first end of the channel comes into contact with a fluid such as blood, the fluid can be withdrawn into the channel. Blood is drawn by capillarity or any other technique described elsewhere herein. The fluid can travel along the length of the channel to the second end of each of the channels. The channels can be fluidly separated from each other. For example, the fluid can enter the first channel 722a via the first end 723a, pass the length of the channel, and exit the first channel at the second end. Similarly, the fluid can enter the second channel 722b via the first end 723b, pass the length of the channel, and exit the second channel at the second end. The first and second channels can be fluidly separated because the fluid from the first channel does not pass through the second channel and vice versa. In some embodiments, the fluid can travel to the second end of the channel without first exiting.

The channels 722a, 722b may have a parallel configuration. For example, the distance between the first ends 723a and 723b of the channel can be approximately the same as between the second ends of the channel. The first ends of the channels may or may not touch each other.

The support 730 may have one or more optical measuring instruments such as optical windows 732a, 732b. The optical window may be placed on the channels 722a, 722b. In some cases, the optical window may be placed over a portion of the channel. A single window can provide a view to a single channel or multiple channels. In one embodiment, the same number of optical windows as the container may be provided. Each optical window can correspond to its own channel. Both the optical window and the channel allow the user to see from outside the sample collection device whether the sample has reached the container and / or has passed through the lower portion of the channel. It can be made of an optically permeable material. Such a determination is useful in determining when to compress the sample collection device.

The base 740 can be attached to the instrument support 730 for the sample collection. The base may or may not be in direct contact with the support. During use of the device, the base may be secured to the support. In some cases, the base may move relative to the support. A portion of the base can be inserted into a portion of the support and / or vice versa. In some embodiments, the base can slide out of the support in the longitudinal direction with respect to the support. In some cases, the base may slide coaxially with the support without rotation. In some cases, the base may rotate without moving relative to the support.

The base 740 may have the ability to support one or more containers 746a, 746b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 730. The height of the base can extend beyond the height of the container. Alternatively, the height of the base can be extended to about or less than the height of the container. The base may have one or more notches, protrusions, grooves, or shaped features to accommodate the container. The base may be formed to have a shape that is complementary to the shape of the container. For example, the base may have one or more tube-shaped notches into which the tube-shaped container may fit snugly. The container may be frictionally fitted into the base. The container may be maintained in an upright position with respect to the base. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

As many containers as the number of channels can be provided. For example, N channels can be provided, followed by N containers, where N is a positive integer (eg, 1, 2, 3, 4, 5, 6, 7, 8). , Or more). Each channel corresponds to its own container. In one embodiment, the sample collection device may have a first container and a second container at the same time as the first channel and the second channel, respectively. The first channel 722a can be configured to communicate with or bring into communication with the first container 746a, and the second channel 722b communicates with the second container 746b. Can be configured to be in a state or brought into a state of communication.

In some embodiments, each container may have a body 749a, 749b and caps 748a, 748b. The container may have any of the features or properties described elsewhere herein.

The base 740 may have one or more optical measuring instruments such as optical windows 742a, 742b. The optical window may be placed on the containers 746a, 746b. In some cases, the optical window may be located in the container body. A single window may provide a view to a single container or multiple containers. In one embodiment, the same number of optical windows as the container may be provided. Each optical window can correspond to a different container. Both the optical window and the container can be formed of an optically permeable material that allows the user to see from outside the sample collection device whether the sample has reached the container. Such a visible assessment can be useful in determining when the sample reaches the container and when the base is removed from the sample collection device.

One or more engaging assemblies may be provided. The engaging assembly may include components exerting forces such as a channel holder 750 and / or a spring 752 or stretchable material. In one embodiment, the holder 750 can continue to secure the adapter channel 754 to the support. As described elsewhere herein, the adapter channel 454 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or a container. It can be a separate element that can be a part. In one embodiment, the holder 750 can prevent the adapter channel 754 from sliding relative to the support. The holder 750 may optionally provide a support on which a force-bearing component, such as a spring, rests.

In one embodiment, the engaging assembly comprises a spring 752, each capable of exerting a force, so that the body 720 can be in an extended state when the spring is in its natural state. obtain. Space may be provided between the containers 746a, 746b and the engaging assembly when the body is in the extended state. When the body 440 is in the stretched state, the internal portion 729 of the body can be exposed and / or not covered by the support 730. In some cases, the second ends 722a, 722b of the channel may or may not touch the cap of the container when the body is in its extended state. The second end of the channel can be in the proper position when not in fluid communication with the interior of the vessel. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

The sample collection device may include any number of engaging assemblies. For example, as many engaging assemblies as the number of channels may be provided. Each channel may have an engaging assembly. For example, if a first channel and a second channel are provided, a first engaging assembly can be provided for the first channel, and for the second channel. A second engaging assembly may be provided. The same number of engaging assemblies and containers may be provided.

8A-8B provide an example of a sample collection device 800 having channels 822a, 822b in fluid communication with the interior of containers 846a, 846b in the device. The sample collection device may include a body 820, a support 830, and a base 840. The body and / or support may support and / or include at least a portion of one, two, or more channels. The channel may extend beyond the edge of the body. The base may support and / or include one, two or more containers.

In one embodiment, the body 820 and / or support 830 may support one or more channels 822a, 822b in the sample collection device. For example, a first channel and a second channel may be provided. Each of the channels may have first ends 823a, 823b that can be provided to the sample receiving end 426 of the instrument, which can extend beyond the body. The first end of each channel can be open. The channel can be opened to the outside air. The channel can be rigid or flexible. In some embodiments, the channels may have a length that allows them to bend and begin contacting each other. If the first end of the channel comes into contact with a fluid such as blood, the fluid can be withdrawn into the channel. Each channel end may be separately contacted with the fluid drawn into each channel. This includes bending the sample collection device at a certain angle so that only one opening into the channel at any given time can come into contact with the sample fluid. Alternatively, all channels can be contacted with the same sample at the same time, and this sample is withdrawn into each channel at the same time. Alternatively, multiple, if not all, channels can be brought into contact with the same sample at the same time, and this sample is extracted into each channel at the same time. The fluid can be removed by capillary action or any other technique described elsewhere herein. The fluid can travel along the length of the channel to the second end of each of the channels. In some embodiments, the fluid can reach the second end of the channel by capillary action or any other technique described elsewhere herein. In other embodiments, the fluid does not need to reach the second end of the channel. The channels can be fluidly separated from each other.

In some embodiments, if the channel is not in fluid communication with the interior of the containers 846a, 846b, the fluid can pass through to the second end of the channel without exiting. For example, the fluid can be drawn into the channel by capillary action and can cause the fluid to flow to or near the channel without causing the fluid to exit the channel.

During use of the device, the body 820 may move relative to the support 830. In some embodiments, the base may slide longitudinally with respect to the support. In one embodiment, the base is compressed (i) a portion that extends when the channel is not in fluid communication with the interior of the container, and (ii) is compressed when it is in fluid communication with the interior of the container. Can have a portion. The sample collection device can be provided in the initially stretched state, as shown in FIG. After the sample has been collected and flowed through the length of the channel, the user pushes in the base as shown in FIG. 8 to provide the sample collecting device with its compressed state. be able to.
In some cases, when the main body is in the extended state, the internal portion of the main body is exposed. When the body is in a compressed state, the internal portion of the body may be covered by the support. The edge of the body may come into contact with the support. Once the base has been pushed in, the base can either remain in the closet naturally or rebound to its stretched state once the pressing force is removed. In some cases, the body can be pulled out in an extended state or fully pulled out to provide access to the container within it. Optionally, in some assemblies, the removal of the body does not provide access to the container.

The base 840 may be attached to the instrument support 830 for the sample collection. The base 840 may have the ability to support one or more containers 846a, 846b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 830. The base may have one or more notches, protrusions, grooves, or shaped features to accommodate the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position with respect to the base.

As many containers as the number of channels can be provided. Each channel corresponds to its own container. In one embodiment, the sample collection device may have a first container and a second container at the same time as the first channel and the second channel, respectively. The first channel 822a can be configured to be in communication with or bring into communication with the first container 846a, and the second channel 822b is in communication with the second container 846b. Can be configured to be in a state or brought into a state of communication. The first channel may not initially be in fluid communication with the first vessel, and the second channel may not be initially in fluid communication with the second vessel. When the body is pushed against the support, the first and second channels can be brought into fluid communication with the interior of the first and second vessels, respectively. When the body is pushed against the support, the first and second channels can be brought into fluid communication with the first and second vessels, respectively. The first and second channels can be brought into fluid communication simultaneously with the first and second vessels, respectively. Alternatively, they do not have to be brought into fluid communication at the same time. The timing of the fluid communication may depend on the height of the vessel and / or the length of the channel. The timing of the fluid communication may depend on the relative distance between the second end of the channel and the vessel.

In some embodiments, each container may have a body 849a, 849b and caps 848a, 848b. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end can be the top end of the container at the end of the container closer to one or more channels. The closed end can be the bottom end of the container, located at the end of the container farther by one or more channels. The closed end can be the bottom end of the container, which can be at an end farther from one or more channels of the container. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

The support 830 may have one or more optical measuring instruments such as optical windows 832a, 832b. The optical window may be placed on the channels 822a, 822b. The optical window may be placed over a portion of the channel. The optical window may provide an indication of whether or not the sample has entered the container. The optical window may indicate how much sample entered the container and / or passed through a portion of the channel indicated by the optical window. This can be useful for the user to assess whether sufficient samples have flowed to push the body into the sample collection device. In some cases, it may be desirable for the sample to reach or near the second end of the channel in the rain that brings the channel to the fluid connection with the vessel. In some cases, it may be desirable for the sample to reach a particular portion of the channel before pushing the body in order to provide the channel with fluid connectivity with the container. A particular portion of the channel may be under the optical window.

The base 840 may have one or more optical measuring instruments such as optical windows 842a, 842b. The optical window may be placed on the containers 846a, 846b. In some cases, the optical window may be located in the container body. The optical window may provide an indication of whether the sample has entered the container. The optical window may indicate how many samples filled the container. This can be useful for assessing whether a sufficient amount of sample has filled the container. In some cases, it may be desirable for a particular amount of sample to enter the vessel before removing the vessel from fluid communication with the channel. It is desirable to have a predetermined volume of sample in the container before removing the base of the device and thereby starting to remove the container from fluid communication with the channel.

The container and / or the channel may have properties or characteristics such as those described elsewhere herein. In some cases, the second end of the channel penetrates the cap of the container, thereby providing the channel for fluid communication with the container. In some cases, the channel can be withdrawn from the container, and the cap of the container can form a liquidtight seal, whereby the channel is out of fluid communication with the container. Allows a liquid-tight environment within the container when done.

One or more engaging assemblies may be provided. This engaging assembly may include a channel holder and / or a force exerting component such as a spring or stretchable material. The holder can continue to secure the channel to the support. The holder may prevent the channel from sliding relative to the support. The holder may optionally provide a support on which a force-bearing component, such as a spring, rests.

In one embodiment, the engaging assembly may include a spring capable of exerting a force because the body can be in an extended state when the spring is in its natural state. Space may be provided between the containers 846a, 846b and the bottom of the sample body 820 when the body is in the stretched state. The second end of the channel can be in place if it is not in fluid communication with the interior of the container.

When the body is press-fitted, the spring 852 can be compressed (see also FIGS. 9A-9C). The second end of the channel can penetrate the cap of the container. The second end of the channel can enter the interior of the container. In some cases, a force may be provided to drive the fluid from the channel into the container. For example, a pressure difference can be created between the first and second ends of the channel. Positive pressure can be provided to the first ends of the channel, 823a, 823b, and / or negative pressure can be provided to the second end of the channel. The positive pressure can be positive with respect to the second end of the channel and / or the outside air. The negative pressure can be negative with respect to the first end of the channel and / or the outside air. In one embodiment, the containers 846a and 846b may have a vacuum therein. When the second end of the channel penetrates the container, the negative pressure in the container draws the sample into the container. In an alternative embodiment, the sample can enter the container, driven by capillary force, gravity, or any other driving force. Optionally, there may be a single or multiple force combination to fill the container with fluid.

In some cases, different types of motives may be used to pull the sample into the channel and to move the sample from the channel into the container. For example, a capillary force can pull the sample into the channel, and a pressure difference can drive the sample out of the channel into the vessel. Any combination of driving forces can be used to withdraw the sample into the channel and the container.

Some time has passed since the sample was introduced into the channel to move along the length of the channel. The user can introduce the sample into the sample collection device and wait for the sample to move the length of the channel. One or more optical instruments may be provided along the length of the channel to indicate if the sample has reached the desired filling level, such as at the end of the channel. In another embodiment, the user can wait a predetermined time before pushing the main body. The user determines that the sample has traveled a sufficient length of the channel and / or the body is pushed in after a sufficient amount of time has elapsed since the sample was introduced. The body has a flat surface to facilitate the user's push. In some cases, the flat surface has a cross-sectional area that may be sufficient for the user's finger to push down on the body. After the body is pushed in, the channel is brought into fluid communication with the container, and samples can flow from the channel into the container. An optical measuring instrument may be provided to allow the user to know when the container was filled.

As soon as the containers are filled, they can be transported to the desired location using the systems and methods described elsewhere herein. As previously mentioned, the entire sample collection device can be transported. In one embodiment, the base portion may be removed from the rest of the device. In one embodiment, the base can be removed from the sample collection device, and the container can be transported with the base. Alternatively, to provide access to the container, the base can be removed from the sample collection device and the container can be removed from the device and delivered.

Examples and of the sample collection device 900 will be described with reference to FIGS. 9A-9C. In one non-limiting example, the device may have a body 920, a support 930, and a base 940. The body 920, support 930, and base 940 can move relative to each other. In some cases, the various components of the device may be mobile between different stages of use. Examples of stages of use include when the device is in the stretched state, in the compressed state, and in the separated state.

FIG. 9A shows an example of the device 900 in the extended state. The main body 920 can extend with respect to the support. Channels 922a, 922b configured to transport the sample may be anchored to the body. The first end of the channel may extend out from the body and / or the rest of the sample collection device. The second end of the channel can be and / or be included in a portion of the sample collection device. The channel can be fluidly separated from each container housed by the base 940. The support 930 may be placed between the body and the base. The support may include, at least in part, a portion of the channel. In some cases, the support may include a second end of the channel.

When in the stretched state, the device may have an stretched length. The length of the device can be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body.

As seen in FIG. 9A, the device 900 may be in an elongated state when the sample is introduced into the device. For example, samples can be contacted by at least the first end of the channel. The sample may be drawn into the channel by capillary action or any other technique or driving force described herein. To pull the sample into the device, the force can act alone or in combination, and the device 900 can remain in an elongated state while the sample traverses the channel. The sample can fill the entire length of the channel, a portion of the length of the channel, or at least a minimum portion to meet the desired sample acquisition volume.

FIG. 9B shows an example of the device 900 in a compressed state. The body 920 may be compressed with respect to the support. The channels 922a and 922b can be fixed to the main body. The channel can be in fluid communication with each container. When the device is brought into a compressed state, the first channel can be brought into the fluid communication with the inside of the first vessel, and the second channel can be brought into the fluid communication with the inside of the second vessel. Can be brought.

As a non-limiting example, the user can push the body 920 against the support 930 (or vice versa) to bring the device into a compressed state. Relative movements between parts may include movements of only one of them. Optionally, the movement may include the movement of only one of them. In this embodiment, the body 920 is last relative to the support 930 so that the internal portion of the body is not exposed and / or the edges of the body can contact the support. Can be pushed up to. Any stopping mechanism that can be engaged when the device is fully compressed can be used. Alternatively, it can only be pressed partially on the body. For example, a portion of the internal portion of the body can be exposed. The support may be placed between the body and the base. The support may include, at least in part, a portion of the channel. In some cases, the second end of the channel may extend beyond the support of the device.

It should be understood that the device 900 may have a compressed length when in a compressed state. The length of the device 900 can be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body. The compressed length of the device may be less than the extended length of the device. In some embodiments, the compressed length of the device is at least about 0.1 cm, 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2 than the extended length of the device. It may be less than .5 cm, 3.0 cm, 3.5 cm, 4.0 cm, or 5.0 cm. The compressed length of the device is about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97% or 99% of the stretched length of the device. It may be there.

The device 900 may be provided with one or more engaging assemblies. The engaging assembly may include components exerting forces such as a channel holder 950 and / or a spring 952 or elastic material. The holder 950 can continue to secure the adapter channel 954 to the support. As described elsewhere herein, the adapter channel 954 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or a container. It can be a separate element that can be a part. In one embodiment, the holder 950 can prevent the adapter channel 954 from sliding relative to the support. The holder 950 may optionally provide a support on which a force-bearing component, such as a spring, rests. When the device is in a compressed state, the exerting component, such as the spring, can be in a compressed state. When the device is in a compressed state, the spring can exert a force on the body of the device.

The instrument may be in a compressed state as the sample is moved from the channel to each container. In some embodiments, the movement is caused by a pressure difference between the channel and the interior of the vessel when they are brought into fluid communication. For example, a second end of the channel can be provided in fluid communication with the interior of the container. The container may have vacuum and / or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be sucked into the vessel. The device may remain in a compressed state while the sample is transferred to the container. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

An example of the device 900 in a separated state is described with reference to FIG. 9C. The base 940 can be separated from the rest of the device 900. The body 920 may be stretched or compressed with respect to the support 930. In one embodiment, the stretched state can be in a natural state such that the body can stretch and return to the stretched state unless a force is exerted on the body by the user. The channels 922a, 922b can be fixed to the body.

The base 940 can be separated from the support 930 of the device when the device 900 is in a separated state. The channels 922a, 922b can be removed from fluid communication with the containers 946a, 946b, respectively. When the device 900 is brought into a separated state, the first channel can be brought into the fluid communication with the inside of the first vessel, and the second channel with the inside of the second vessel. Can be brought to fluid communication. This can happen sequentially or simultaneously. When the channel is removed from the container, the container can be kept sealed to prevent unwanted substances from entering the container. In some embodiments, the container can become liquidtight after removing the channel. Optionally, the container can become airtight after the channel has been removed.

The user may separate the base 940 from the support 930 to bring the base 940 into a separated state in the device to remove the container therein. In embodiments, the base can be separated from the support and vice versa. Separating the base from the support can expose the containers 946a, 946b supported by the base. The container is held in the base by press fitting or other means. The containers 946a, 946b can be removed from the base. As a non-limiting example, removing the containers 946a, 946b allows it to be placed in another container whose temperature and humidity have been adjusted for transport to the analytical facility. Optionally, the containers 946a, 946b may be removed to allow pretreatment, such as centrifugation, before being sent for processing in the analytical facility. Alternatively, the containers 946a, 946b may stay with the base.

10A-10B provide an additional diagram of the sample collection device 1000 in a separated state. When in the separated state, the base 1040 can be separated (partially or completely) from the support 1030 and / or the body 1020 of the device. This allows removal of the containers 1046a and 1046b through the end of the base 1040, which is not exposed to the outside when the device 1000 is not in a separated state.

When the device is in a separated state, the one or more channels 1022a, 1022b are fluidly separated from the one or more containers 1046a, 1046b housed in the base 1040. The containers can be fluidly sealed from their environment. The containers can be moved through the collection channel into it to reach minimal filling levels, and then each container can contain a substantially completely deposited sample. The base 1040 may include one or more optical measuring instruments 1046a, 1046b. The optical measuring instrument shows a part of the container in the container so as not to move the device 1000 into a separated state until the minimum filling level is reached. As a non-limiting example, the container may have an optically permeable material that allows the user to view the sample in the container from outside the base.

In some embodiments, the base 1040 may include at least a portion of the container. It may have a hollow interior of the base and a wall surrounding the hollow interior. The base may have one or more shaped features that support the container. The container may be provided within the hollow interior. The wall can surround the container. The base may have an open top through which the container is exposed. The container may or may not be removed through this open top.

Collection equipment with multiple collection channels

Further embodiments described herein are described with reference to FIGS. 11A-11F. This embodiment provides a body fluid sample collection device 1100 used for collecting fluid samples, which can be pooled or otherwise formed on body surfaces such as, but not limited to, subject skin or other target areas. To do. It should be understood that this embodiment shows a device body defining at least two collection channels with different volumes therein, but does not exclude equipment with fewer or more collection channels. .. Embodiments in which the same collection volume is used for one or more of the channels are also not excluded. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

FIG. 11A shows a perspective view of an embodiment of a body fluid sample collection device 1100 having a distal end 1102 configured to engage a fluid sample on the surface. In this embodiment, the distal end 1102 may have a shape for better engagement with a pool of drops or fluid on the surface or a formed sample. In some embodiments, in addition to the desired shape, to facilitate fluid flow towards one or more openings 1104 and 1106 on the distal end 1102 that guide the channel into the device 1100. Surface treatments such as, but not limited to, chemical treatments, texturing, surface features, or coatings may also be present at the distal end 1102.

As seen in FIG. 11A, this embodiment of the sample collection device 1100 has two openings 1104 and for receiving the sample fluid. It should be understood that some embodiments may have more than two openings at the distal end. Some embodiments may have only one opening at the distal end. Optionally, some embodiments may have additional openings along the sides or other surfaces protruding from the distal end 1102 of the device 1100. The openings 1104 and 1106 may have any cross-sectional shape. In some non-limiting examples, the opening has the shape of a circle, oval, triangle, quadrangle (eg, square, rectangle, trapezoid), pentagon, hexagon, octagon, or any other cross section. obtain. The shape of the cross section can remain the same or vary along the length of the collector body. In some cases, the opening is about ^{2mm 2, 1.5mm 2, 1mm 2} , 0.8mm 2, 0.5mm 2, may have a 0.3 mm ² or 0.1 mm ² or less of the cross-sectional area, .. Some embodiments have said openings of the same shape. Others may use different shapes for one or more openings.

The sample filling portion 1120, which can be the body of the sample collecting device 1100, allows the user to see if a sample has entered a sample collecting channel (see FIG. 11B) within the sample filling portion 1120. Can be formed of transparent and / or translucent material. In some embodiments, the entire sample filling portion 1120 is transparent or translucent. Alternatively, some embodiments select only the entire area above the channel or the channel or sample filling portion 1120 to allow the user to visualize the filling of the sample into the sample collecting device 1100. Only the area marked can be transparent or translucent. Optionally, the sample filling portion is formed of an opaque material, but has openings or windows for visualization of the filling level therein. The device 1100 may further include one or more visualization windows 1112 and 1114 that allow the user to see if the desired filling level has been reached. This visualization window can be made of transparent and / or translucent material. Alternatively, this visualization window can be an opening that has no substance in it. An additional visualization window can also be used to determine if all the fluid in the collection channel has been emptied and entered the containers 1146a and 1146b (see FIG. 11B).

FIG. 11A shows the filling levels in the containers 1146a and 1146b to show if some embodiments of the support 1130 have moved the container in the base 1140 to a position to receive the sample fluid. It is also shown that it may have optical windows 1132 and 1134 arranged for. Optionally, the windows 1132 and 1134 can be cutouts that act as guides to the snap features of the base for determining "start" and "end" during activation. It should be understood that the base may be configured to hold one or more sample containers. By way of example, but not by limitation, the entire base 1140 may be removed from the sample collection device before or after sample filling. The base 1140 can be used as a holder to hold the sample container therein during transport, and in such embodiments, the base 1140 and the sample container are for shipping trays or transport. Can be loaded into the holder of. Alternatively, in some embodiments, the sample container can be removed from the base 1140 and then the container can be transported without the base 1140 holding it.

FIG. 11B shows a cross-sectional view taken along the cutting line BB of the embodiment shown in FIG. 11C. FIG. 11B shows the channels 1126 and 1128 within the portion 1120. The sample-filled portion 1120 may be formed from two or more pieces to be bonded in order to define the portion 1120. The channel can be defined within one piece, and may then have another piece that matches the first piece for defining the opposite wall or top wall of the channel. it can. With respect to manufacturing, one piece is allowed to have a channel formed or otherwise formed in the body, and the opposite piece acts as a cover for the channel. It can also be combined or include a portion of said channel. The channels 1126 and 1128 may be formed only within the portion 1120 or may extend into a support 1130 that has the characteristic of binding to the container held in the base or carrier 1140. In some embodiments, the parts 1120 and 1130 may be integrally formed together. Supports 1130 may also be configured to hold fluidly connected to said channels 1126 and 1128 with containers 1146a and 1146b, respectively.

Although these embodiments herein are described by using two channels and two containers, it should be understood that no other number of channels and containers are excluded. Some embodiments may have more channels than containers, with several channels linked to the same container. Some embodiments may have more vessels than channels, with multiple vessels operably linked to the same channel.

As seen in FIG. 11B, the channels 1126 and 1128 can be of different sizes. This allows different fluid volumes to be collected in each channel before being transferred to the containers 1146a and 1146b. Optionally, some embodiments may have channels 1126 and 1128 formed to accommodate the same volume of fluid. In some embodiments, the openings in the vicinity of the distal end 1102 are closer to each other than those at the proximal end, which may be arranged further apart for entry into the containers 1146a and 1146b. The fluid paths of the channels 1126 and 1128 are shaped and / or angled so that they can. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

FIG. 11B also shows that some embodiments may use needles for adapter channels 1150 and 1152 in the body 1130 that communicate with the channels 1126 and 1128. Each of the needles has a channel that allows fluid to pass through it from the collection channels 1126 and 1128 to the end of the needle. As seen in FIG. 11B, the containers 1146a and 1146b in the base 1140 may slide relative to the support 1130, as indicated by arrow 1156. Relative movement between the support 1130 and the base 1140 can close the interval 1160. Closing the interval 1160 brings the adapter channel 1150 into the cap 1148a of the container 1146a until fluid communication is formed within the container 1146a and between the collection channels 1126. At that point, the driving force in the embodiment moves the fluid in the channel 1126 into the container 1146a.

Any combination of driving forces, as an example and not a limitation, can be used to draw the sample into the container. In some embodiments, vacuum pulling in the container 1146a may be used to pull the sample into the container. A pushing force from an external pressure can be used to move the fluid into the container. Some embodiments may use both. It may depend on capillaries and / or gravity. In some embodiments, the motive force used to pull the sample into the channel is different from the motive force used to pull the sample into the container. In some alternative embodiments, the driving force is the same at each stage. In some embodiments, the driving force is applied sequentially or at a defined time. As a non-limiting example, the driving force for drawing the sample into the container is not applied until at least one channel reaches the minimum filling level. Optionally, no driving force is applied to pull the sample into the container until the two channels each reach a minimum filling level. Optionally, the driving force for pulling the sample into the vessel is not applied until all channels have reached their respective minimum filling levels. In some embodiments, the driving force is applied simultaneously. This enumerated feature may apply to any embodiment herein.

An enlarged cross-sectional view of the device 1100 is shown with reference to FIG. 11E. This embodiment is sufficient to prevent the support 1130 from crossing over the adapter channels 1150 and 1152 and preventing the user from inserting the finger within the interval 1160 and penetrating the finger with one of the needles. It is shown to have an edge portion 1136 shaped to stretch in a large amount.

Additionally, as shown in FIGS. 11B and 11E, the present embodiment has at least two channels in the sample collection device 1100. This allows each of the channels 1128 and 1126 to introduce different substances into the sample, respectively. As a non-limiting example, if the sample is whole blood, one channel can introduce heparin into the blood, while another channel introduces ethylenediaminetetraacetic acid (EDTA). These anticoagulants not only prevent premature coagulation while the channel is filled, but also introduce the anticoagulant into the whole blood in preparation for transport to the containers 1146a and 1146b. Optionally, the channel may also be plasma coated in place of or in combination with the anticoagulant. This plasma coating can reduce the flow resistance of the fluid sample as it enters the channel. Such a coating, along with any other coating used in said channel, may be coated with a pattern such as, but not limited to, strips, rings, or other patterns.

Optionally, a sufficient amount of anticoagulant is provided so that the sample fluid can contain the desired level of anticoagulant after it has passed through the channel only once. Is in the channel of. In conventional blood vials, the blood sample is free of anticoagulant until it is in the vial, and once in the vial, a technician to allow mixing of the anticoagulant in the vial. Typically, the vial is repeated, tilted, shaken, and / or agitated. In this embodiment, the sample fluid has an anticoagulant before entering the sample container, and does so without the need to repeatedly tilt or agitate the sample collection device. In embodiments herein, a single pass provides sufficient time and sufficient concentration of additives such as anticoagulants into the sample fluid. In one embodiment, the EDTA channel has a volume of 54 μL coated with 200 mg / mL EDTA; the heparin channel has a volume of about 22 μL coated with 250 units / mL heparin. In another embodiment, the EDTA channel has a volume of 70 μL coated with 300 mg / mL EDTA; the heparin channel has a volume of about 30 μL coated with 250 units / mL heparin. As a non-limiting example, a channel with a volume of 50-70 μL can be covered with EDTA in the range of about 200-300 mg / mL EDTA. Optionally, channels with a volume of 70-100 μL can be covered with EDTA in the range of about 300-450 mg / mLEDTA. Optionally, channels with a volume of 20-30 μL can be covered with heparin in the range of 250 units / mL heparin. As an example, the material can be solution coated on the surface of the target in less than an hour and then dried overnight. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

Further embodiments will be described with reference to FIG. 11G. In the embodiment of FIG. 11G, instead of having one opening 1204 for each of the channels at the distal end 1202 of the sample collection device 1200, the sample collection device 1200 has two or more of the channels. Merge into a single channel. The embodiment of FIG. 11G shows that there is a common channel portion before this common channel branches into a plurality of separate channels. Optionally, reduce sample withdrawal from one channel to another and / or sample withdrawal from said channel into said sample vessel during filling, as discussed in FIG. 11I below. Therefore, there may be backflow prevention, such as, but not limited to, vents along separate channels.

As seen in FIG. 11H, the use of this common flow path can result in a reduced number of external openings of the sample collection device 1200 that align the openings 1204 to engage with body fluid samples. .. This also increases the capillary force for extracting the fluid sample to the sample collection device 1200 by having more capillaries that attract the same channel where the fluid sample enters the collection device.

A cross-sectional view of selected components of the sample collection device is described with reference to FIG. 11I. FIG. 11I shows that the sample collection device may have two channels 1182 and 1184 with a common portion 1186 leading towards an inhalation opening on the device. In some embodiments, this common portion 1186 can be a continuation of the size, shape, and / or orientation of one of the channels 1182 or 1184. Optionally, this common portion 1186 may be in fluid communication with said channels 1182, 1184, or this common portion 1186, of the same size, shape, and / or orientation as any other channel. I don't have either. FIG. 11I shows that in one non-limiting example, there may be a step at the junction 1188 between the channels 1182 and 1184. This junction 1188 may be configured to ensure flow into said channel so that both of the two channels are fully filled. In one embodiment, the junction 1188 has a larger size than the channel 1182 exiting the junction 1188. Other sizes are not excluded, but the larger size, this junction 1188 has sufficient flow, but in this embodiment the channel has a smaller diameter and a reduced volume as compared to the channel 1184. It can be guaranteed to enter 1182. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

FIG. 11I may also have vents 1190 and 1192 which can be used to prevent cross-flow between channels, especially when the sample is being moved into the sample vessel. Shown. In one embodiment, the vents 1190 and 1192 may be open at all times. In another embodiment, the vents 1190 and 1192 can be opened only when selected, such as, but not limited to, after the channels 1182 and 1184 have been or are substantially filled. In some embodiments, soluble materials may be used that block the vents 1190 and 1192 until they come into contact with the sample fluid. Optionally, some embodiments may use a slidable cover on one or more of the vents 1190 and 1192 that opens only when selected by the user. In one embodiment, the movement of the sample vessel moving to enter fluid communication with the channel can also open one or more vents 1190 and 1192 to reduce the risk of crossflow between channels. As such, this cover is connected to the sample container. Optionally, other cross-flow prevention mechanisms such as valves, gates, or plugs can also be used to prevent fluid from moving between channels 1190 and 1192.

FIG. 11I also shows that there may be a leak prevention device 1194 located between the adapters 1150 and 1152. In this embodiment, the leakage prevention device 1194 is a frit, which ensures that the adapter delivers the fluid into the sample container from a first position that prevents the sample from leaking from the adapters 1150 and 1152. It can be slidably moved to an acceptable second position. In one non-limiting embodiment, the leak prevention device 1194 slides when engaged by the sample container or a housing that holds the sample container. In this non-limiting example, the movement of the sample container or its housing indicates that the movement of those elements also causes the movement of the leak prevention device 1194.

Then, with reference to FIG. 11J, still another embodiment of the sample collection device 1160 will be described. This embodiment of the sample collection device 1160 indicates that the device 1160 has a sample inlet location 1204 leading to a plurality of channels 1162 and 1164 in the device 1160. FIG. 11J shows that channels 1162 and 1164 can have different shapes and / or sizes, but some embodiments may be configured to have the same volume and / or shape. The location of the sample inlet 1204 can be on the surface of the equipment 1160, or optionally, it can be on a tip, nozzle, stub, or other protrusion extending from the body of the equipment 1160. I want to be understood. The protrusions can be coplanar and parallel to the device, or optionally, it can be aligned at an angle because the axis of the protrusion intersects the plane of the device 1160. ..

FIG. 11J further shows that in some embodiments, there may be sample flow features 1166 and 1168 that pull the sample in the desired direction or otherwise preferentially direct it. In some embodiments, the features 1166 and 1168 are guides that act to reduce the dimension of the channel by at least one axis, such as, but not limited to, width or height, and thus the reduced dimension. Increases capillary action through the area of. In one non-limiting example, these flow features 1166 and 1168 can assist the flow of fluid through the channel region located near the anti-cross current feature 1170 while the sample enters the channel. In one embodiment, the flow features 1166 and 1168 are sized to preferentially improve inward flow when the flow is primarily pulled out by capillary action. In one scenario, the outward flow is based on vacuum pulling force (from adjacent channels, etc.) rather than capillary force, and in this embodiment, these flow features 1166 and 1168 are of non-capillary flow. , Such a vacuum is not configured to provide assistance. Thus, some, but not all, of the flow features 1166 and 1168 are configured to assist in at least one type of flow condition, but not in any other specific flow condition. Optionally, some embodiments may include other techniques alone or, but not limited to, said guides such as shaped features, hydrophobic materials, or other techniques of pushing / pulling a sample to a desired location. Can be used in combination with.

FIG. 11J is a cone in which the samples are funnel-shaped in order to minimize the amount of samples that can be retained in the channel and are not collected in one or more of the embodiments described herein. It is also shown that there may be an angled side wall feature 1167 (not shown) that narrows the cross-sectional area of the channel, either in shape or otherwise. FIG. 11J also shows that during manufacturing, there may be a positioning feature 1169 (not shown) to facilitate the bonding of parts together in a defined location and orientation.

FIG. 11K shows a side view of the sample collection device 1160 of this embodiment. A side view of the instrument 1160 is, but not limited to, an outlet for minimizing undesired cross-flow of samples between channels 1162 and 1164, especially once the desired filling level has been reached for each channel. It is shown that there is an embodiment of one or more anti-cross current features 1170, such as. The anti-cross current features 1170 and 1172 can prevent cross flow by disrupting the fluid path produced by the outlet. The cross-flow problem most commonly arises when the vessel 1140 in the holder is engaged and provides additional driving force to pull the sample out of the channel into the vessel. This "pulling" effect can, for some reason, pull the sample from one channel to an adjacent channel. To minimize cross-flow, the forces associated with pulling the sample from the channel into the vessel pull from the outlet rather than from the fluid in the adjacent channel, thus minimizing unwanted sample mixing. ..

FIG. 11K also shows that in some embodiments herein, there may be intersections 1130 and 1140 that may be adapted for use with different sample filling portions 1120. Different Capillary Filling Fills can be used that use different types of capture techniques, such as samples from the subject's venous, arterial, or internal locations or target sites.

An embodiment of the sample flow features 1166 and 1168 is shown with reference to FIG. 11L. This cross-sectional view of a sample collection portion having channels 1162 and 1164 and the sample flow features 1166 and 1168 near the common inlet path 1165 is such features desirable in embodiments close to where the sample enters the channel. Show that. It may also be desirable to position the inlet 1165 closer to the channel 1164 with the larger volume, as shown in FIG. 11L at the asymmetric location of the inlet 1165 for channels of different volumes. Shown. It also shows that in some embodiments, the locations of the sample flow features 1166 and 1168 can be selected to control the filling rate, filling volume, etc. into the sample collecting device 1160. It should be understood that one or more of the described features may be adapted for use in other embodiments herein.

With reference to FIG. 11M, channels 1162 and 1164 with sample anti-cross current characteristics are shown. In one embodiment, the anti-cross current feature of the sample is outlets 1170 and 1172 located on at least one surface of channels 1162 and 1164. In one unrestricted example, in the instrument, these sample anti-cross current features are located near any sample flow features 1166 and 1168. In one embodiment, these anti-cross current features are configured to prevent flow between channels. These anti-cross current features are such that the anti-cross current features 1170 and 1172 are overloaded when the channels that can be located near the location of the maximum filling of each channel are at or near its maximum sample capacity. Filled samples are arranged to prevent samples being processed in one channel from entering another channel and causing undesired mixing of samples in two channels. To.

FIG. 11N shows a perspective view of the sample collection device with sample filling indicators 1112 and 1114. In one embodiment, these indicators 1112 and 1114 are either openings or transparent portions of said equipment 1160 that allow observation of at least one portion of channel 1162 or 1164. When the sample is visible on at least one indicator 1112 and 1114, it then signals the user to take another action, such as engaging, but not limited to, the sample container in the holder 1140. I will provide a. In some embodiments, there is only one sample filling indicator that replaces the indication of sufficient filling of the sample in more than one channel. In some embodiments, the activity of engaging the sample container is performed only when indicated by the indicators 1112 and 1114. In some embodiments, the activity of engaging the sample container is performed only when indicated by only one of the indicators.

With reference to FIGS. 11O, 11P, and 11Q, cross sections at various locations along one embodiment of said equipment 1160 in FIG. 11J are shown. FIG. 11W shows a cross section showing the sample flow features 1166 and 1168. The anti-cross current features 1170 and 1172 are also shown. Engagement features 1174 are also provided to allow the pieces to be joined together to form the device 1160.

FIG. 11P shows that adapter channels 1150 and 1152 are positioned because they extend into or at least have fluid communication with the sample channels 1162 and 1164. Optionally, some embodiments may have multiple lumen adapter channels 1150 or 1152. Optionally, some embodiments may have multiple adapter channels per sample channel, and such additional channels may be parallel, angled, or entangled with each other ( Wrapped), or otherwise oriented relatively.

FIG. 11Q shows that, in some embodiments, the container holder 1140 can be shaped non-contrastly (on a cross-sectional plane), or else, in the device 1160, the holder 1140 Shaped to allow acceptance in only one orientation. This is especially desirable when it is desired to direct the sample from a particular channel to the selected container. If the holder 1140 can be inserted in various orientations, the sample from one channel can result in incorrect container entry. Optionally, other features Suchas alignment features, slots, visual cues, texture cues, and / or similar ones can be used to facilitate the orientation of the sample container in a suitable manner for the instrument.

Integrated tissue penetration member

Further embodiments of the sample collection device will be described with reference to FIG. 11R. The sample collection device 1210 includes features similar to those shown in FIG. 11G, except that it further includes a tissue penetrating member attached to the sample collection device 1210. An actuating mechanism 1214, such as, but not limited to, a spring actuating device, may be used to launch the tissue penetrating member. FIG. 11Z shows the dormant actuation mechanism 1214, which is a spring that can be compressed to fire the tissue penetrating member 1212 towards the target tissue. The tissue penetrating member 1212 may be housed in a housing 1216 (shown by a dotted line). In one embodiment, the housing 1216 can be stripped, penetrating, not only to allow the tissue penetrating member 1212 to exit the housing, but also to maintain the sterility of the tissue penetrating member 1212 prior to its use. Includes parts that can be opened, opened, or otherwise opened. In some embodiments, the portion is a foil, cap, polymer layer, and the like. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

In one embodiment, the path of the tissue penetrating member 1212 is both in a "normal" (ie, forward direction of the tissue penetrating member) and "perpendicular" (ie, perpendicular to the principal motion vector) trajectory. Along, it can be controlled. Some embodiments do not have a hard stop (hard s apex) or abrupt stop (bang s apex) at the deepest point of penetration (ie, return point), which is the main cause of spontaneous pain. May be good. Some embodiments may use cushions, cam paths, or other non-hard stop mechanisms to prevent pain associated with the shock wave of a sudden stop. Such a shock wave can activate such a nerve even if direct contact is avoided, even if the tissue penetrating member successfully avoids hitting a nerve near the injured site. Harmful because of. Optionally, in some embodiments, the tissue penetrating member can follow a non-exciting pathway (non-jitter path) to prevent rough wound channels (residual pain). In some embodiments, this can be achieved with tighter accuracy in the induction path used with the tissue penetrating member, or in the pins associated with said tissue penetrating member. This can be a non-exciting pathway when penetrating tissue. Optionally, the tissue penetrating member can be a non-exciting pathway both when it is outside the tissue and when it is inside the tissue. It can reduce the "wobble" of the tissue-penetrating member, which can cause residual pain, long-lasting scarring, and scarring.

Some embodiments may have controlled outward velocities to prevent slow and delayed wound sutures and subsequent bleeding. As a non-limiting example, the controlled outward velocity of the tissue penetrating member can be controlled by a mechanical mechanism such as, but not limited to, a cam or higher friction material.

Some embodiments may also include anti-rebound mechanisms to prevent unintended repenetration associated with uncontrolled tissue penetrating members that recoil into the tissue after the initial wound is formed. .. Some embodiments herein are the tissue-penetrating member or ancillary thereof to prevent re-entry into the tissue as soon as the tissue-penetrating member is retracted or retracted by a desired distance. It may have a "parking" or lockout mechanism that engages with an object.

The suddenness of the lancet stopping in the skin at its maximum depth, before it begins its outward movement, and returning to its starting point is a problem inherent in this design. When the lancet is at the deepest penetration point, the maximum amount of force is applied to the skin. This drive mechanism simply bounces the edge of the device so that the ball bounces off the floor. The lancet suddenly stops at the end of its inward movement, sending a shock wave into the skin, causing many pain receptors near the lancet to become agitated, even if not struck directly. .. This greatly amplifies spontaneous pain.

As mentioned, instead of a tissue penetrating member actuated by a simple spring, some embodiments may use mechanical cam actuation. Equipment with a cam-actuated design can minimize the "hard stop" of the tissue penetration member. The cam mechanism is usually driven by a spring and generally provides a better guided operation. The trajectory of the tissue-penetrating member is tightly controlled by a guided path of the tissue-penetrating member holder via a pin resting on the cam. The cam mechanism allows for a given velocity profile with a gentle return for the outward trajectory of the tissue penetrating member and clear velocity control. When the mechanism reaches the end point of the movement, the mechanism can also effectively prevent the lancet from bouncing into the skin. In addition, the mechanical vibration (or fluctuation / wobble) of the lancet's path in both directions is reduced when launched into the air. Some embodiments herein also have any mechanical wobbling of the driving mechanism (eg, for example, in order to prevent such wobbling of the driving mechanism from being transmitted to the tissue by its "forced motion profile". (Due to non-uniform or coarse cam slots) can also be minimized.

Optionally, some embodiments may use electronic operation by an electronically controlled drive mechanism. This technique uses a miniaturized electronic motor (eg, voice coil, solenoid) coupled with a highly accurate position sensor to skin the tissue penetrating member with precisely controlled motion and speed. Move in or out of the skin. Following rapid invasion, without irritation, and relatively slowly, in order to return smoothly, the device decelerates the tissue penetrating member to a precise predetermined depth. This makes it possible to avoid early wound sutures and long-term wounds. The device controls the force required to penetrate the lancet through the skin while the tissue penetrating member is advancing. The advantage of tightly controlling the working "profile" of the tissue penetrating member is a reproducible, painless puncture that produces sufficient and consistent blood samples for examination.

With respect to the generation of a puncture site for drawing a blood sample, it is desirable to choose a suitable puncture site above one of the patient's fingers (ring finger or middle finger) of the non-dominant hand. The puncture site can be on the side of the fingertip. In one unrestricted embodiment, it is desirable to apply a hand warming strip to the patient's selected fingers for 15 seconds. Optionally, the patient's fingers can be warmed for 10-60 seconds. In other cases it can be warmed longer. Warming increases blood flow to the target site. To prepare the target site, it is desirable to ensure that the selected puncture site is wiped by wiping the tip of the side of the selected finger, or the surface of the patient, with alcohol or a similar cleaning agent. In some embodiments, it is desirable to wait until the skin is completely dry. Typically, do not wipe with gauze or keep air on your fingertips to speed up drying.

After the puncture hole is formed, hold the hand down below the patient's waist to allow blood to flow. Gently massage your finger from the base of your fingertip until a drop of blood is formed. Carefully fill the blood collection device by touching the tip of the device with a drop of blood on the finger. Make sure that the equipment is completely filled. As soon as the blood collection device is filled, press the bleeding area of your finger against the gauze pad on the table. The blood sample is moved into the collection vessel. Place the bandage on your finger. Place the container with the sample in the shipping box in the refrigerator. Discard all supplies in medical needle containers for biologically hazardous substances. All supplies are disposable.

If sufficient blood is not obtained by the first puncture, carefully place the blood collecting device on the surface of the table to ensure that the device is level. Place the bandage on the punctured finger. Select the appropriate puncture site for different fingers of the same hand of the patient. If the ring finger is punctured first, a new puncture site is selected on the middle finger and vice versa. A piece of warming hand is applied to the patient's selected finger for 60 seconds. The patient's fingers can be optionally warmed for 30-90 seconds. This increases blood flow to the fingers. These techniques for blood collection using a sample collection device, such as those herein, are clinical in institutions and / or standards certified by the Clinical Laboratory Improvement Amendment (CLIA). Allows sufficient sampling of capillary blood for use in testing.

Further another embodiment of the sample collection device 1220 is described with reference to FIG. 11S. In this embodiment, the tissue penetrating member 1222 can be attached at an angle to the sample collecting device 1220. This angled configuration allows the tissue penetration member to generate a wound where it aligns with the sample acquisition openings 1103 and 1105. An actuating device 1224 launched by a standard spring is shown as a drive mechanism for the tissue penetration member 1222, but a cam and / or electrical drive system is also used in place of or in combination with the spring launcher. It should also be understood that it can be used. If the drive mechanism 1224 is a spring, the spring can be compressed to move the tissue penetrating member 1222 to the starting position and then released to penetrate into the target tissue. FIG. 11S shows the tissue penetrating member 1222 in the resting position. This figure shows a spring for the drive mechanism 1224, but does not exclude other drive mechanisms suitable for use in firing tissue penetration members to create a healable wound in the subject. Please understand that. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

A housing 1226 similar to that described for the housing 1216 may be formed around the tissue penetrating member 1222. FIG. 11S shows two tissue-penetrating members 1222 attached to the sample collection device, but it should be understood that equipment with more or less tissue-penetrating members is not excluded. For example, some embodiments may have only one tissue penetrating member 1222 attached to the sample collection device 1220. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

Another embodiment of the sample collection device 1230 will be described with reference to FIG. 11T. In this embodiment, the tissue penetrating member 1232 is housed in the sample collection device 1230, and as seen in FIG. 11T, it is actually aligned coaxially with the central axis of the sample collection device. .. At this position, the tissue penetrating member 1232 extends outward from the sample collection device 1230 at a location close to where the openings 1103 and 1105 are located on the sample collection device 1230. Of course, devices with more or less openings are not excluded, and embodiments of FIG. 11T are exemplary and non-limiting. FIG. 11T shows that in one embodiment of the sample collection device, the launch button 1234 can be attached to the sample collection device 1230. Optionally, some embodiments may have a shaped tip 1236 that acts as an actuating button, and when the tissue is squeezed against the tip 1236 at a particular depth and / or a particular pressure, said The tissue penetration member is activated.

Upon firing, the tissue penetrating member 1232 moves as indicated by arrow 1233. In some embodiments, the tissue penetration member 1232 is fully contained within the sample collection device 1230 prior to operation. Some embodiments are visible measurements on the device 1230 to help the user guide where the tissue penetrating member 1232 exits the device and roughly where the wound is formed. It may have a vessel 1235.

In this non-limiting embodiment, the entire device 1230 is contained in a bag or packaging that can only be opened before the device 1230 is used. In this way, the tissue penetrating member and the collecting device are maintained aseptic before use. This external sterile bag or packaging applies to any of the other embodiments herein. FIG. 11T also shows a shaped tip 1236 (shown by a dotted line) that can be formed integrally or separately attached to the sample collection device 1230. This shaped tip 1236 may provide suction that pulls the sample fluid into the sample collection device 1230. Optionally, the shaped tip 1236 target tissue is stretched and / or shaped to apply pressure to increase the production of sample fluid from the wound formed by the tissue penetrating member 1232. Can be used to force inside. It should be understood that any embodiment herein can be adapted to have a shaped tip 1236. Optionally, the shaped tip may have a selected hydrophobic region to direct the sample fluid to one or more collection areas on the tip. Optionally, the shaped tip may have a selected hydrophilic region to direct the sample fluid to one or more collection areas on the tip.

Yet another embodiment of the sample collection device will be described with reference to FIG. 11U. This embodiment is similar to that of FIG. 11T, except that instead of a single tissue penetrating member such as a lancet, the embodiment of FIG. 11U uses a plurality of tissue penetrating members 1242. In one embodiment, these tissue penetrating members are microneedle 1242 with a reduced diameter as compared to conventional lancets. Multiple microneedle 1242 can be activated simultaneously for device 1240 and generate multiple wound sites on the tissue. The spacing of the microneedle 1242 can result in more capillary loops being punctured, and more channels are available for blood to reach the tissue surface. This allows for a more "square" penetration profile compared to lancets with pointed tips and tapered profiles. This allows the microneedle 1242 to engage more capillary loops on a larger area without going too deep into the deeper panniculus, where more nerve terminals are present. be able to.

Further embodiments of the sample collection device will be described with reference to FIGS. 11V and 11W. In the embodiments shown in these figures, the sample collection device 1100 is angled and attached to a dedicated wound making device 1250 having a tissue penetrating member 1252 configured to extend forward from the wound making device 1250. Can be. The sample collection device 1100, optionally configured to have a shaped tip 1236 (with or without an opening to receive the tissue penetration member 1252), is a wound creation device 1250. Can be detachably attached to. Optionally, the sample collection device 1100 can be mounted flat on the device 1250. Optionally, there may be a shaped notch on the device 1250 to hold the sample collection device 1100 by press fitting. It should be understood that other techniques for detachably attaching the sample collection device 1100 are not excluded. The separation of the collection device and the wound creation device allows the use of the wound creation device 1250, which can generate a wound creation experience with more sophisticated, reusable, controlled and alleviated pain.

FIG. 11W shows that the sample collection device 1100 can be below horizontal in order to be neutral with respect to the gravitational effect on the sample collection. Other attachment configurations of the device 1100 to the wound making device 1250 are not excluded.

Further embodiments of various sample collection devices are described with reference to FIGS. 11X-11Z. FIG. 11X shows a sample collection device in which a shaped tip 1236 can be used with said device 1240. This shaped tip 1236 is similar to that previously described. A vacuum source 1270 can be used to extract body fluid samples into the instrument 1240. The vacuum source 1270 may be coupled to the body of the equipment 1240 and / or the shaped tip 1236. It should be understood that any embodiment described in this disclosure may be adapted for use with, but not limited to, sample acquisition assistive devices such as vacuum source 1270.

FIG. 11Y shows yet another embodiment of the sample collection device. A pipette system with a tip 1280 for collecting the sample fluid of this embodiment is used. The tip may include a coaxially mounted tissue penetration member 1282. Optionally, side-mounted or angled tissue-penetrating member 1284 for creating a wound at the target site is shown. The pipette system with the tip 1280 applies vacuum to draw the sample fluid from the subject. Optionally, the shaped tip 1236 can be used with the tip 1280 to assist in skin stretching or tissue remodeling at the target site.

FIG. 11Z shows that some embodiments may use a diaphragm 1291 coupled to an actuating mechanism to create a vacuum for drawing a blood sample. This connection allows the diaphragm to create a vacuum in one round trip return of the tissue penetration member 1292 from the target site. In one embodiment, the tissue penetrating member 1292 is a microneedle. The actuation of the tissue penetrating member, indicated by arrow 1294, originates the tissue penetrating member 1292 and, on the return path, creates a vacuum due to the motion of the diaphragm linked to the motion of the tissue penetrating member 1292. One or more containers 1296 may be linked to hold the fluid collected by the instrument 1290. Some embodiments have only one container 1296. Some embodiments may have a set of containers 1296. Some embodiments may have multiple sets of containers 1296. Some embodiments may be mounted on the outside of the device 1290. Some embodiments may be mounted on the inside of the device 1290. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.
Limiting vertical outflow

FIG. 11E also more clearly shows that there is a sleeve 1156 around the adapters 1150 and 1152. Although shown only in FIGS. 11A-11F, it is understood that sleeves with or without vents can be configured for use with any of the embodiments discussed herein. I want to. As seen in the embodiment of FIG. 11E, the channel is defined by a needle. These sleeves 1156 prevent premature outflow of fluid samples from the adapter channels 1150 and 1152 before the containers 1146a and 1146b engage the needle. Due to the low volume of sample fluid required, prevention of premature outflow reduces the loss of fluid volume associated with the movement of fluid from said channel to said vessel. In one embodiment, the sleeve 1156 can minimize fluid loss by providing a sleeve that is liquid but not airtight. If the sleeve is airtight, it can prevent the capillary action of the channel from working properly. Optionally, in some embodiments, the vent may be placed near the base away from the tip of the needle so that the sleeve can accommodate the sample in a location away from the vent.

FIG. 11F shows that in an exemplary embodiment, the sleeve 1156 is configured to have a sleeve 1158 penetrating the sleeve. This provides an improved embodiment over conventional sleeves that are typically loosely fitted over the needle. Due to the loose fit, in conventional sleeves, the sleeve space is in the tip and in the side wall space between the needle and the sleeve, in which fluid samples can accumulate. Sleeves of this design can prevent greater loss of fluid by limiting the loss to a defined amount compared to sleeveless needles that can continuously lose fluid, but along the tip and sidewalls. The fluid that accumulates in the sleeve area is still lost and is not collected by the container 1146a or 1146b. The sleeve 1156 provides, but is not limited to, a needle, probe, tube, channel, or needle, probe, tube, channel, or to facilitate engagement of the sleeve with the device, which provides fluid communication with the channels 1126 and 1128. It may include a narrowed area 1176, such as another adapter channel 1150. It should be understood that some embodiments of the equipment shown in FIG. 11 may not have a sleeve 1156, but instead use a frit 1194 or the like. Optionally, some embodiments may have no flow limiting item.

In the embodiment of FIG. 11F, the sleeve 1158 is sized based on a calculation that sufficiently withstands the flow pressure associated with the flow from the capillary action of the channel in the sample filling portion 1120. This force not only allows the sleeve 1158 to be there to vent air from the channel, but also the containers 1146a and 1146b are pressed against and engaged with the adapter channels 1150 and 1152. Prevents fluid from exiting the sleeve until Due to the ventilation effect produced by the sleeve 1158, the sidewall and other areas of the sleeve can be engaged with the needle much more tightly than in a conventional sleeve. The space between the needle and the sleeve can be reduced, thus minimizing the amount of fluid lost due to the looseness of the fit compared to a sleeve without vents with much larger spacing. In addition, the sleeve 1158 has sufficient resistance as soon as the fluid reaches the opening so that there is minimal fluid loss at any distance between the sleeve and the tip of the needle. Can be sized so that outflow from the channel or needle is also stopped.

The calculation for sizing the opening is as shown in FIG. The hope is to balance the forces so that there is sufficient leakage protection associated with the hydrophobic material that defines the vents to prevent the outflow of sample fluid outside the sleeve. is there. In FIG. 12, the side wall of the sleeve 1156 can be in direct contact with the needle, or in some embodiments, may be spaced along the side wall with the sleeve. In one embodiment, the sleeve 1156 includes, but is not limited to, a hydrophobic substance such as a thermoplastic elastomer (TPE), butyl rubber, silicone, or other hydrophobic substance. In one embodiment, the thickness of the sleeve also determines the length of the vent 1180 in the side wall of the opening or in the sleeve 1156.

The sleeve 1158 may be placed in one or more locations along the sleeve 1156. Some may have as shown in FIG. Alternatively, some embodiments may have the sleeve 1158 on the side wall of the sleeve. Other locations are not excluded. Optionally, the sleeve 1156 may have multiple openings through the sleeve, but keep the fluid out of the sleeve, and the container 1146a or 1146b is engaged, and the channel and fluid. The resistance from the opening is configured to be sufficient to prevent additional outflow from the channel until communication is achieved.

With respect to how the device 1100 is used to collect samples, in one technique the sample collection device 1100 is held to engage with the target body fluid and the desired filling level is achieved. It is kept in place until it is reached. During this time, the device 1100 can be held horizontally to minimize gravity, and if the device 1100 is held more vertically, it needs to overcome gravity. After reaching the filling level, the device 1100 can be disengaged with the fluid of interest and then can also be disengaged with the containers 1146a and 1146b engaged to draw the fluid into the container. Optionally, the device 1100 contacts the target fluid so that the filling also draws out the fluid in the channel and possibly some additional sample fluid remaining at the target site, and the vessel It can engage with the channel and remain fluid communication. This ensures that sufficient fluid is withdrawn into the container.

After filling the containers 1146a and 1146b, they are prepared for shipping. Optionally, they are sent to pre-processing prior to shipping. In some embodiments of the containers 1146a and 1146b, after a pretreatment such as centrifugation, due to the density selected, another of the samples in which the material was centrifuged in the same container. The container contains a dense substance that becomes a portion separated from the portion.

The container 1146a or 1146b may have vacuum and / or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be sucked into the vessel. Optionally, the container may take the form of a test tube-like device that falls into the category of being marketed under the "Vacutainer" trademark from the Becton-Dickinson Company in East Rutherford, NJ. While the sample is moved to the container, the instrument may remain in a compressed state with the base 1140 closed at intervals of 1160. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

In one embodiment described herein, the two-step filling of the sample collection device 1100 with the sample fluid is i) a sufficient amount of the collection channel processed to prevent premature blood clots. It enables a weighed collection of the sample fluid to ensure that it is in, and then ii) an efficient mode of transferring a high percentage of the sample fluid into the container. The low loss filling of the vessel from this prefilling channel for measuring the minimum fluid volume of the sample into the vessel 1146 provides multiple advantages, especially when dealing with the collection of small volumes of sample fluid. Prefilling the channel to the desired level ensures that there is sufficient volume in the container to carry out the desired test of the sample fluid.

In another embodiment described herein, the entire device, including said sample filling portion 1120, support 1130, and base 1140, is either completely transparent or completely transparent to allow visualization of the components within it. It is translucent. Optionally, only one of the sample filling portion 1120, the support 1130, and the base 1140 is completely transparent or translucent. Optionally, only selected portions of the sample filling portion 1120, support 1130, or base 1140 are transparent or translucent. As a result, the user can more accurately determine when the various procedures should be performed based on the progress of the sample fluid filling and the engagement of the sample container with the channel in the sample filling portion 1120. Bubbles in the collection channel are visible during filling, and if bubbles are seen, the user can position the sample collection device 1100 at the target sample to minimize air drawn into the channel. Adjustable for better engagement with fluid. This allows the user to know when to separate or disengage a piece such as the base or container holder 1140 when filling is complete.

Other methods prevent outward sample flow from the adapter channels 1150 and 1152 when the device is held at a non-horizontal angle, such as, but not limited to, a downwardly vertical mode. Please understand that it can be used for. In one embodiment, the frit 1194 can be used with a needle with a central hole, which can be used as the adapter channels 1150 and 1152. The frit can be in the body of the sample collection device or on the collection container. In some embodiments, the frit comprises, but is not limited to, a substance such as PTFE. Optionally, some embodiments may use tape / adhesive on needles acting as the adapter channels 1150 and 1152. In one embodiment, the tape / adhesive can be used to cover the opening of the needle to prevent premature release of the sample. Optionally, some embodiments may have adapter channels 1150 and 1152 with a hydrophobic surface to prevent controlled outflow from the adapter channel opening leading to the sample container. In some embodiments, the adapter channels 1150 and 1152 are needles having a hydrophobic substance only on the inner surface near the outlet. Optionally, the hydrophobic material is only on the outer surface of the needle near the outlet. Optionally, the hydrophobic material is on the inner and outer surfaces of the needle. Optionally, another way to prevent downward flow is to increase the surface area by varying the cross-sectional area of the capillaries. As a non-limiting example, some embodiments may introduce a tooth or finger-like structure inside the capillary to increase the cross-sectional area of the capillary. Optionally, some embodiments may include fins inside the capillary that are oriented towards and / or opposite to the flow of fluid in order to increase the cross-sectional area of the capillary. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

Position of one sample collector for multiple channels

Still another embodiment described herein is described with reference to FIGS. 13A-13B. FIG. 13A shows a sample filling portion 1320 having a single collection point 1322, such as a collection well, where two channels 1324 and 1326 meet to drain fluid from the single collection point 1322, without limitation. The figure looking down from above is shown. Optionally, some embodiments branch into channels 1324 and 1326 after only a single channel is a single common channel exiting the collection site 1322 and then exiting the collection site 1322. A Y-branch channel configuration can be used. Members that provide fluid communication with the channels 1324 and 1326 include, but are not limited to, needles, probes, tubes, channels, hollow elongated members, or other structures at one end of the sample filling portion 1320. Can be connected.

FIG. 13B is a side cross-sectional view showing, but not limited to, an adapter channel 1352, such as a fluid communication member, followed by a fluid communication channel 1326 and a collection location 1322 in fluid communication. In some embodiments, the fluid communication member has sufficient rigidity and is sufficient to allow the tip to penetrate the septum, cap, or other structure of the container. Some may have the adapter channels 1352, 1150 and the like in a non-hollow structure to leave unsealed holes in the container's septum, cap, or other structure.

As seen in FIG. 13B, as shown by Drop D, the sample fluid is either applied or dropped into the collection site 1322. Optionally, some may be applied directly to or in direct contact with the collection site 1322 to apply the sample fluid. Although the embodiments herein show the use of only a single collection point 1322, it should be understood that other embodiments in which multiple channels are linked to a common sample collection point are envisioned. As a non-limiting example, one embodiment of a collection device may have two collection points 1322, each with its own channel exiting its respective collection point. In some embodiments, the common collection point channel shown in FIGS. 13A-13B can be combined with a separate channel as shown in FIGS. 11A-11F. Other combinations of common collection site structures with other structures with separate channels are not excluded.

FIG. 13B also shows that this embodiment may include one or more tissue penetrating members 1327 configured to extend outward from said collection site 1322. In one embodiment, this allows the user to simultaneously place the target tissue and wound creation site for fluid sample acquisition on the collection site 1322. Optionally, a pull iron 1323 may be placed to fire the tissue penetrating member. Optionally, this trigger is in the joint with the tissue of the device to allow firing of the device when the target tissue is in contact and / or sufficient pressure or contact is in place. Incorporated in. The overlap of these two locations allows for a simplified protocol that users should follow for successful sample collection. The tissue penetrating member 1327 can be actuated by one or more actuation techniques, such as, but not limited to, spring actuation, spring / cam actuation, electronic actuation, or the single or combination of the above. For improved sampling, other assistive methods, such as, but not limited to, vacuum sources, tissue expansion devices, tissue expansion precursors, etc., may be used alone or in combination with any of the aforementioned. I want to be understood.

Further embodiments of the sample collection device are described with reference to FIG. 13C. This embodiment shows a cartridge 1400 in which a sample collection device 1402 is integrated. There is a collection site 1322, as well as one or more sample openings 1325 and one or more sample openings 1325 in which samples collected at location 1322, such as, but not limited to, pipette tip handling (not shown), can then be accessed. There are 1329. The sample from the drop D travels along the path 1326 towards the openings 1325 and 1329 and towards the openings 1325 and 1329, respectively, as indicated by the arrows. And some of the pathways 1324 and / or 1326 are withdrawn into pipette P. As indicated by the arrow beside the pipette P, the pipette P can move within at least one axis to allow the sample fluid to be transported to the desired location. In this embodiment, the cartridge 1400 may have a plurality of holding containers 1410 for reagents, cleaning solutions, mixing regions, incubation regions, and the like. Optionally, the cartridge 1400 some embodiments do not include a retaining vessel at all, or optionally have only one or two types of retaining vessels. Optionally, in some embodiments, the holding vessel may be a pipette tip. Optionally, in some embodiments, the holding vessel can be a pipette tip that has been treated to contain reagents on the tip surface (typically the inner surface of the tip, but other surfaces. Is not excluded). Optionally, some embodiments of the cartridge 1400 include only the sample collection device 1402 without the tissue penetrating member, and vice versa.

A side sectional view of the embodiment of FIG. 13C is shown with reference to FIG. 13D. Optionally, at location 1322, tissue penetration member 1327 may be included for use in creating a wound for the sample fluid to be collected.

FIG. 14 shows that the sample filling portion 1320 can be combined with the supports 1330 and 1340 to form the sample collecting device 1300. There may be a visualization window 1312 to see if the sample fluid has reached the desired filling level. It may include components that exert force, such as springs 1356 or stretchable materials. The channel holder can keep the channel fixed to the support. In one embodiment, the holder may prevent the channel from sliding relative to the support. It may use press fit, mechanical fasteners, adhesives, or other attachment techniques to connect to the channel. The holder may optionally provide a support on which a force-bearing component, such as a spring, can rest.

In one embodiment, the engaging assembly may include a spring 1356 capable of exerting a force so that the base 1340 can be in an extended state when in its natural state. Space may be provided between the containers 1346a, 1346b and the engaging assembly when the base is in an extended state. In some cases, the second end of the channel may or may not touch the cap of the container when the base 1340 is in the extended state. The second ends 325a and 325b of the fluid communication member 1352 may be in proper positions if they are not in fluid communication with the inside of the container.

When the member 1352 penetrates the cap into the container and thus withdraws the sample fluid into the containers 1346a and 1346b, joining the support 1330 and the base 1340 can be done with the channels 1324 and 1326. Provides fluid communication with the container 1346a and 1346b.

The container 1346a or 1346b may have vacuum and / or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be sucked into the vessel. The device can remain compressed with the positioned base 1340 so that the container can be in fluid communication with the channels 1326 and 1328 while the sample is moved to the container. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

As seen in FIG. 15, in one embodiment described herein, the two-step filling of the sample collecting device 1300 with the sample fluid i) a sufficient amount prevents premature blood clots. Weighed collection of the sample fluid to ensure that it is in the processed collection channel, and then ii) an efficient mode of transferring a high percentage of the sample fluid into the container. to enable. The low loss filling of the vessel from this prefilling channel for measuring the minimum fluid volume of the sample into said vessel 1346 provides multiple advantages, especially when dealing with the collection of small volumes of sample fluid. Prefilling the channel to the desired level ensures that there is sufficient volume in the container to carry out the desired test of the sample fluid.

Further embodiments will be described with reference to FIGS. 16 and 17. FIG. 16 shows a blood collection device 1300 having a secondary collection area 1324 around the collection site 1322. The secondary collection area 1324 can be used to direct any overflow, spilled, or misdirected fluid sample to the collection site 1322.

FIG. 17 further shows that the containers 1346a and 1346b may have identifiers associated with the containers 1346a and 1346b, respectively. FIG. 17 shows, in one non-limiting example, the identifiers 1600 and 1602 barcodes (eg, 1-D, 2-D, or 3-D), quick response (QR) code, image, shape. , Language, number, alphanumeric string, color, or any combination thereof, or at least one of any type of visible identifier. Others may use identifiers that are not visible spectra. And can use RFID tags, RF identifiers, IR emission tags, or other markers that are independent of identification by signals sent over the visible spectrum.

Identifiers 1600 and 1602 can be used to identify the sample and / or sample type in the sample collection instrument. There may be one or more identifiers per container. Some may also use the identifier on the container holder. The identifier may identify the sample collection device, one or more individual containers within the device, or a component of the device. In some cases, the sample collection device, a portion of the sample collection device, and / or the container may be transported. In one embodiment, the sample collection device, a portion of the sample collection device, may be transported via a delivery service, or any other service described elsewhere herein. The sample may be delivered to perform one or more tests on the sample.

The identification of the sample and / or the identification of the individual who provided the sample can be tracked. It may include information that accompanies the individual (eg, name, contact information, social security number, birthday, insurance information, billing information, medical history), as well as other information about who provided the sample. In some cases, the type of sample (eg, whole blood, plasma, urine, etc.) can be tracked. The type of reagent that the sample should encounter (eg, anticoagulant, label, etc.) can be tracked. Additional information about the sample collection, the date and / or time of collection, the circumstances under which the sample was collected, the type of test to be performed on the sample, insurance information, medical record information, or any other information. Type information can be considered.

Identifiers help track such information. The identifier is associated with such information. Such information may be stored offboard the sample collection device, onboard the sample collection device, or in any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device with storage. In some cases, the information may be stored on the cloud computing infrastructure. One or more resources for storing the information may be distributed on the cloud. In some cases, a peer-to-peer infrastructure may be provided. The information may be stored in the identifier itself, or elsewhere may be associated with the identifier, or any combination thereof.

The identifier may provide a unique identification, or a high probability of providing a unique identification. In some cases, the identifier may include visible components. The identifier is optically detectable. In some cases, the identifier may be identifiable using visible light. The identifiers 1600 and 1602 barcodes (eg, 1-D, 2-D, or 3-D), quick response (QR) codes, images, shapes, languages, numbers, alphanumeric strings, colors, or It can be any combination of them, or at least one of any type of visible identifier.

In other embodiments, the identifier may be optically detectable by any other type of radiation. For example, the identifier can be detected via infrared, ultraviolet, or any other type of electromagnetic spectrum wavelength. The identifier may utilize luminescence such as fluorescence, chemiluminescence, bioluminescence, or any other type of optical luminescence. In some cases, the identifier can be a radio transmitter and / or receiver. The identifier can be a radio frequency identification (RFID) tag. The identifier may be any type of radio transmitter and / or receiver. The identifier may transmit one or more electrical signals. In some cases, GPS or other location signals may be utilized by the identifier.

The identifier may include a voice component, or an acoustic component. The identifier may generate an identifiable sound to uniquely identify the identified component.

The identifier can be detected via an optical detection device. For example, a barcode scanner may have the ability to read the identifier. In another example, a camera (eg, a still or video image) or other image capture device may have the ability to capture the image of the identifier and analyze the image to determine the identification.

16 and 17 show examples of identifiers provided for use with the sample collection device 1300 according to the embodiments described herein. In one embodiment, the sample collection device may have a base 1340 that supports and / or contains one or more containers 1346a, 1346b. Samples may be provided to the sample collection device. The sample may be provided to the sample collection device via an inlet 1322. The sample can move to one or more containers 1346a, 1346b in the instrument.

One or more identifiers 1600, 1602 may be provided on the sample collection device. In some embodiments, the identifier is located at the base 1340 of the sample collection device. The identifier can be located on the bottom surface of the base, the side surface of the base, or any other part of the base. In one embodiment, the base may have a flat bottom surface. The identifier can be on the flat bottom surface of the base. One or more notches may be provided in the base. The identifier may be placed inside the notch. The notch may be on the bottom or side of the base. In some embodiments, the base may include one or more protrusions. The identifier can be on the protrusion. In some cases, the identifier may be provided on the outer surface of the base. The identifier may instead be located on the inner surface of the base. The identifier can be detected from outside the sample collection device.

In some embodiments, the identifier may be provided on the containers 1346a, 1346. The identifier can be on the outer surface of the container or on the inner surface of the container. The identifier can be detected from the outside of the container. In some embodiments, the identifier may be provided on the bottom surface of the container.

In one embodiment, the base may include an optically transparent portion. The optically transmissive portion may be on the bottom or side of the base. For example, transparent or translucent windows may be provided. In another example, the optically transmissive portion is a hole that does not require a window. The optically transparent portion allows a portion of the inside of the base to be visualized. The identifier can be provided on an optically transparent portion of the outer surface of the base, an inner surface of the base, but can be visualized through the optically transparent portion, or outside the container. Alternatively, it may be provided on the inner surface, but can be visualized through the optically transparent portion. In some cases, the identifier may be provided on the inner surface of the container, but the container is optically such that the identifier can be seen through the container and / or an optically transparent portion. It can be transparent.

The identifier may be a QR code® or other optical identifier that can be optically visualized from outside the sample collection device. The QR code can be visualized through an optical window or a hole in the bottom of the base of the sample collection device. The QR code may be provided at the base of the sample collection device or a portion of the container visible through the base. An image capture device such as a camera or scanner can be provided externally to the sample collection device and may have the ability to read the QR code.

A single or multiple QR codes, or other identifiers, may be provided on the sample collection device. In some cases, each container may have at least one, associated identifier, such as a QR code. In one embodiment, at least one window per container can be provided within the base, and each window allows the user to see the QR code or other identifier. For example, two containers 1346a, 1346b can be housed within the base 1340, each of which has an associated identifier 1600, 1602 identifiable from the outside of the sample collection device.

The base 1340 may be separated from the support 1330 or other part of the sample collection device. The identifier may be separated from the rest of the sample collection device along the base.

In some embodiments, the identifier may be provided in a container housed in the base. Separating the base from the rest of the sample collection device can cause the container to be separated from the rest of the sample collection device. The container can remain in or be removed from the base. Even if the container is removed from the base, the identifier can remain with the container. Alternatively, when the container is removed, the identifier can remain within the base. In some cases, both the base and the container may have an identifier so that the container and the base can be tracked separately and / or adapted even if separated.

In some cases, any number of containers may be provided within the sample collection device. The sample container may be capable of accepting samples from the subject. Each sample container may have a unique identifier. The unique identifier can be associated with any information about the sample, subject, device, or component of the device.

In some cases, each identifier for each container can be unique. In other embodiments, the identifier on the container does not have to be unique, but can be unique with respect to the device, the subject, or the type of sample.

The sample collection device can receive samples from the subject. The subject may come into direct contact with the sample collection device or may provide a sample to the device. The sample may travel through the device to one or more containers within the device. In some cases, the sample can be processed before reaching the container. One or more coatings or substances may be provided within a sample collection unit and / or channel capable of transporting the sample to the container. Alternatively, the sample is not provided for treatment before reaching the container. In some embodiments, the sample may or may not be processed in the container. In some cases, the sample may be provided with a plurality of different types of treatment before or when the sample reaches the container. The processes may be provided in a preselected order. For example, the first desired process may be provided upstream of the second process. In some cases, the sample is not processed at any point.

In some embodiments, the said may be a blood sample. The first container can receive whole blood, and the second container can receive blood plasma. Anticoagulants may be provided along the fluid pathway and / or in the container.

Once the sample has been provided to the container and the container has been sealed, the container can be sent to another location for sample analysis. The alternative location can be a clinical laboratory. The separate location may be a facility remote to the sample collection site. The entire sample collection device can be sent to the separate location. One or more identifiers can be provided on the sample collection device, and it can be useful for identifying the sample collection device and / or the container therein. Alternatively, the base 1340 can be removed from the sample collection device and shipped with the container therein to the separate location. One or more identifiers can be provided on the base, which can be useful for identifying the base and / or the container therein. In some cases, the container can be removed from the base and shipped to the separate location. One or more identifiers can be provided on each container, which can be useful for identifying said container.

The identifier can be read by any suitable technique. As a non-limiting example, in some cases the identifier can be read using an image capture device or an optical detector such as a barcode scanner. In one embodiment, the image capture device may capture the image of the QR code. Information related to the container can be tracked. For example, when a container arrives at a location, the identifier can be scanned, and a record of the arrival of the container can be maintained. The position of the progress and / or the container can be actively and / or passively updated. In some cases, the identifier may need to be deliberately scanned to determine the location of the container. In another example, the identifier actively emits a signal that can be picked up by a signal reader. For example, as the identifier moves through the building, the signal reader can track the location to the identifier.

In some cases, reading the identifier allows the user to access additional information associated with the identifier. For example, the user may capture an image of the identifier using a device. The device or another device may display information about the sample, subject, device, components of the device, or any other information described elsewhere herein. It may contain information about the tests to be performed and / or the test results. The user may perform subsequent tests or activities on the sample based on the information associated with the identifier. For example, the user can direct the container to a suitable location for inspection. In some cases, the container can be directed to the appropriate location and / or the contents in the container, appropriately performed in an automated manner without the need for human intervention. Sample processing (eg, sample pretreatment, assay, detection, analysis) can be provided.

Information about sample processing is collected and associated with the identifier. For example, if a container has an identifier and sample processing is performed on the contents of said container, one or more signals generated in response to said sample processing can be stored and / or It can be associated with the identifier. Such updates can be done in an automated manner without the need for human intervention. Alternatively, the user can start saving the information or enter the information manually. Therefore, medical records about the subject can be aggregated in an automated fashion. The identifier may be useful for indexing and / or accessing information about the subject.

Sample container

18A-18B show a non-limiting example of a sample container 1800 that can be used with a sample collection device according to the embodiments described herein. In some cases, the container may be supported by the sample collection device. The container can be included or enclosed by a portion of the sample collection device. In one embodiment, the sample collection device may have a first configuration in which the container is completely closed. A second configuration may be provided in which the sample collection device is opened and at least a portion of the container is exposed. In some embodiments, the container can be supported by the base of the sample collection device and / or at least partially enclosed. The base can be separated from the rest of the sample collection device, thereby providing access to the container therein.

In the case of body fluid collection, the sample fluid, both of which are incorporated herein by reference in their entirety, is filed September 6, 2012, US Provisional Patent Application No. 61 / 697,797. Blood can be collected from the patient using the sample collection device described in No. and the US Provisional Patent Application No. 61 / 798,873, which was filed on March 15, 2013. As a non-limiting example of a blood sample, some embodiments may collect the blood sample through the collection of capillary blood from the subject. This can be done by means of a wound, a penetrating site, or another access site to capillary blood from said subject. Optionally, blood can also be collected by venous puncture or puncture of other blood vessels to obtain a blood sample for filling in the sample container. For example, the blood can be collected by a device configured to collect a small volume of blood by venipuncture. Such equipment includes, for example, a container with a small internal volume requirement and a hollow needle that is fluidly coupled or has the ability to be fluidly coupled. The container having a small internal volume requirement is, for example, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 100 μL, 90 μL, 80 μL, 70 μL, 60 μL, 50 μL, 40 μL, 30 μL, 20 μL, It has a volume of 10 μL or 5 μL or less. Other types and techniques of equipment for collecting body fluids are not excluded.

Various methods, including, but not limited to, fingertip puncture, puncture, injection, pumping, wiping, pipetting, venous blood sampling, venous puncture, and / or other techniques described elsewhere herein. Removes body fluid from the subject and provides it to the device. In some embodiments, the sample can also be collected from the exhaled breath of the subject. The body fluid can be provided using a body fluid collector. Fluid collectors include lancets, capillaries, tubes, pipettes, syringes, needles, microneedle, pumps, or any other collector described elsewhere herein. In some embodiments, the sample may be a tissue sample provided by the subject. The sample can be removed from the subject or discarded by the subject.

In one embodiment, the subject's skin is punctured by a lancet and the sample is withdrawn using, for example, gravity, capillary action, suction, pressure difference or vacuum. The lancet, or any other fluid collector, may be a portion of the device, a cartridge of the device, a part of the system, or a stand-alone component. If required, the lancet or any other fluid collector may be mechanically, electrically, electromechanically, or by any other well-known activation mechanism or any combination of such methods. Can be activated.

In one example, a subject's finger (another part of the subject's body) may be punctured to produce fluid. The body fluid can be collected using capillaries, pipettes, wipes, drops, or any other mechanism well known in the art. The capillary or pipette may be separate from or part of the device and / or cartridge of the device that is inserted into the device and / or attached to the device. In another embodiment that does not require an active mechanism, the subject can simply donate body fluids to the device and / or cartridge, as in the case of saliva samples, for example.

Body fluids are removed from the subject and provided to the device by a variety of methods, including, but not limited to, fingertip puncture, puncture, infusion, pumping, wiping, and / or pipetting. The body fluid can be collected by an intravenous or non-venous method. The body fluid can be collected using a body fluid collector. Fluid collectors include lancets, capillaries, tubes, pipettes, venous blood draws, or any other collector described elsewhere herein. In one embodiment, the skin is punctured by a lancet and the sample is withdrawn using, for example, gravity, capillary action, suction, or vacuum. The lancet can be a portion of the device, a cartridge of the device, a part of the system, or a stand-alone component. If required, the lancet or any other fluid collector may be mechanically, electrically, electromechanically, or by any other well-known activation mechanism or any combination of such methods. Can be activated. In one example, a subject's finger (another part of the subject's body) may be punctured to produce fluid. Examples of other parts of the subject's body include, but are not limited to, the subject's hands, wrists, arms, torso, legs, feet, ears, or neck. The body fluid can be collected using capillaries, pipettes, or any other mechanism well known in the art. The capillary or pipette may be separate from the device and / or cartridge, or may be a component of the device and / or cartridge or container. In another embodiment where no active mechanism is required, the subject may simply provide body fluids to the device and / or cartridge, as occurs with saliva samples. The collected fluid can be placed in the instrument. The bodily fluid collector may be attached to the device, detachably attached to the device, or provided separately from the device.

Samples obtained from the subject can be stored in sample container 1800. In one embodiment described herein, the sample container 1800 includes a body 1810 and a cap 1820. In some cases, at least a portion of the sample container body may be formed from a transparent or translucent material. The sample container body allows the sample provided within the sample container body to be visible when viewed from the outside of the sample container. The sample container body may be optically transparent. The sample container body can be formed from a substance that allows electromagnetic radiation to pass through. In some cases, the sample container body may be formed of a substance that allows electromagnetic radiation of selected wavelengths to pass, while not allowing other electromagnetic radiation of selected wavelengths to pass through. In some cases, part or all of the body may be formed of a material that is opaque between selected wavelengths of electromagnetic radiation, such as the wavelength of visible light. Optionally, some parts of the sample container body are shaped to provide a particular optical path length. Optionally, some parts of the sample container body provide a flat surface (external and / or internal) or other structure to allow analysis of the sample while in the sample container. Shaped for.

In one embodiment, an open end and a closed end may be provided on the sample container body 1810. The open end, which may be at the end configured to engage the cap, can be the top end 1812 of the sample container 1800. The closed end can be the bottom end 1814 of the sample container, which can be at the end of the container opposite the cap. In an alternative embodiment, the bottom edge can also be an open edge that can be closed with the floor. In some embodiments, the cross-sectional area and / or the shape of the top edge and the bottom edge can be substantially the same. Alternatively, the cross-sectional area of the top edge can be greater than the cross-sectional area of the bottom edge, and vice versa. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

In one embodiment, the sample container body may have an inner surface and an outer surface. The surface of the sample container body may be smooth, rough, textured, faceted, shiny, dull, grooved, girder-containing, or may contain any other features. The surface of the sample container body can be treated to provide the desired optical properties. The inner and outer surfaces can have the same properties or can be different. For example, the outer surface can be smooth, while the inner surface can be rough.

Optionally, the sample container body may have a tubular shape. In some cases, the sample container body may have a cylindrical portion. Alternatively, the sample container may include an oval, a triangle, a quadrangle (eg, a square, a rectangle, a trapezoid, a parallelogram), a pentagon, a hexagon, a heptagon, an octagon, or any other shape. It may have other cross-sectional shapes. The cross-sectional shape of the sample container may or may not have a convex and / or concave shape. The shape of the cross section of the sample container can be the same or variable along the length of the sample container. The sample container may have a prismatic shape along the length of the main body. The prism may have a cross-sectional shape similar to that described herein.

Optionally, the bottom 1814 of the sample container can be flat, tapered, rounded, or any combination thereof. In some cases, the sample container may have a hemispherical bottom. In other embodiments, the sample container may have a rounded bottom with a flat portion. The sample container may or may not stand on a flat surface by itself.

In one embodiment, the sample container 1800 can be sized to contain a small amount of fluid sample. In some embodiments, the sample container is approximately 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 μL, 800 μL, 700 μL, 600 μL, 500 μL, 400 μL, 300 μL, 250 μL, 200 μL, 150 μL, 100 μL, 80 μL. , 50 μL, 30 μL, 25 μL, 20 μL, 10 μL, 7 μL, 5 μL, 3 μL, 2 μL, 1 μL, 750 nL, 500 nL, 250 nL, 200 nL, 150 nL, 100 nL, 50 nL, 10 nL, 5 nL, 1 nL, 500 pL, 300 pL, 100 pL, 50 pL, 10 pl. It may be configured to accommodate as much as 5, 5 pL, or 1 pL. As an unrestricted example, the sample container may have an information storage unit on it, as discussed in FIGS. 1F and 1G. In one non-limiting example, in order to hold the sample fluid in a liquid state during movement, the sample container 100 absorbs a small volume of the sample fluid by capillary action, such as a substance, mesh, solid matrix, etc. Can be retained without using. This means that the sample fluid does not lose the sample or its integrity due to the liquid being absorbed from the sample container in a liquid state by a substance or other substance that is substantially absorbed by the capillary action. , Allows it to be removed.

Optionally, the sample container 1800 can be configured to contain only a few drops of blood, a drop of blood, or less than a drop of blood. For example, the sample container may have a smaller internal volume than the amount of fluid sample it is configured to contain. Having a small container can advantageously tolerate the storage and / or transport of a large number of sample containers in a small volume. This can reduce resources for storing and / or transporting the sample container. For example, less storage space is needed. In addition, less cost and / or fuel may be used to transport the sample container. More sample containers can be transported with the same workload.

In some embodiments, the sample container 1800 may have a short length. For example, the lengths of the sample container are 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, and so on. 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0.1 cm, 700 μm, 500 m, 300 μm, 100 μm, 70 μm, 50 μm, 30 μm, It can be on the order of 10 μm, 7 μm, 5 μm, 30 μm, or 1 μm. In some cases, the maximum dimensions of the sample container (eg, length, width, or diameter) are 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1. 7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0. It can be on the order of 1 cm, 700 μm, 500 m, 300 μm, 100 μm, 70 μm, 50 μm, 30 μm, 10 μm, 7 μm, 5 μm, 30 μm, or 1 μm.

The sample container 1800 may have a cross-sectional area. The cross-sectional area is about 8 cm ² , 7 cm ² , 6 cm ² , 5 cm ² , 4 cm ² , 3.5 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.9 cm ² , ^{0.8cm 2, 0.7cm 2, 0.6cm 2} , 0.5cm 2, 0.4cm 2, 0.3cm 2, 0.2cm 2, 0.1cm 2, 0.07cm 2, 0.05cm 2, It can be on the order of 0.03 ^{cm 2} , 0.02 cm ² , 0.01 cm ² , 0.5 cm ² , 0.3 cm ² , or 0.1 cm ² . The cross-sectional area can be the same or vary along the length of the container.

The sample container 1800 can have any thickness. The thickness can be the same or vary along the length of the sample container. In some cases, the thickness can be selected and / or varied to provide the desired optical properties. In some cases, the thicknesses are 5 mm, 3 mm, 2 mm, 1 mm, 700 μm, 500 μm, 300 μm, 200 μm, 150 μm, 100 μm, 70 μm, 50 μm, 30 μm, 10 μm, 7 μm, 5 μm, 3 μm, 1 μm, 700 nm, 500 nm. It can be on the order of 300 nm or 100 nm.

In one embodiment, the sample container 1800 may have a shape that contributes to allow centrifugation of a small volume of blood sample. This allows the collected sample in the sample vessel to be transported directly towards the centrifuge without the need to further move the sample fluid to another sample vessel used for the centrifuge. To.

Optionally, the sample container may include a cap 1820. The cap may be configured to cover and fit over the open end of the sample container. The cap may block the open end of the sample container. The cap may fluidly seal the sample container. The cap may form a liquidtight seal with the sample container body. For example, the cap can be gas and / or liquid impermeable. Alternatively, the cap may allow certain gases and / or liquids to pass through. In some cases, the cap is gas permeable while liquid opaque. The cap may be opaque to the sample. For example, the cap can be impermeable to whole blood, serum or plasma.

The cap may be configured to engage the container body in any manner. For example, the cap can be press-fitted into the container body. Friction fitting or tightening allows the cap to stay in the body. In other examples, locking mechanisms such as sliding mechanisms, clamps, fasteners, or other techniques may be provided. In some cases, the cap and / or the sample container body can be threaded to allow threaded engagement. In another example, glue, welding, soldering, or brazing can be used to connect the cap to the sample container body. The cap can be detachably attached to the sample container body. Alternatively, the cap may be permanently secured to the sample container body.

In some cases, a portion of the cap may fit into a portion of the sample container body. The cap may form a stopper with the sample container body. In some cases, a portion of the sample container body may fit into the portion of the cap. The plug may include a rim or shelf that can project over a portion of the sample container body. The rim or shelf can prevent the cap from slipping into the sample container body. In some cases, a portion of the cap may lie on the top and / or side of the sample container body. Optionally, some embodiments may include additional parts, such as cap holders, within the container assembly. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and the sample container. In one embodiment, the cap holder engages with an accessory, edge, notch, or other accessory location on the outside of the sample container to hold the cap in place. .. Optionally, some embodiments may combine the functions of the cap and said cap holder in one component.

In some embodiments, it may be formed of the sample container body rigid material. For example, the sample container body may be made of a polymer such as polypropylene, polystyrene, or acrylic. In an alternative embodiment, the sample container body can be semi-rigid or flexible. The sample container body can be formed from a single integrated piece. Alternatively, multiple pieces may be used. The plurality of pieces may be formed from the same substance or different substances.

Optionally, the sample container cap can be formed from an elastomeric material, or any other material described elsewhere herein. In some cases, the cap may be made of rubber, polymer, or any other material that may be flexible and / or compressible. Alternatively, the cap can be semi-rigid or rigid. The sample container cap may be formed from a friction material. The sample container cap may form a liquidtight seal when engaged with the sample container body. The inner body of the sample container can be fluidly separated from the outside air. In some cases, at least one cap and / or a portion of the sample container body in contact with the cap can be formed by high friction and / or compressible material.

In one embodiment, the cap 1820 is in an automatically sealed, open end of the sample vessel that is piercable by a needle and / or cannula to maintain a vacuum and / or closed atmosphere in the sample vessel. It can be an airtight closure during the sealing engagement of the. In some embodiments, the interior of the sample vessel is simply a partial vacuum rather than a complete vacuum. Excessive vacuum can damage blood components formed in the sample fluid. As a non-limiting example, the partial vacuum is in the range of about 50-60% of the complete vacuum. Optionally, the partial vacuum does not exceed about 60% of the complete vacuum. Optionally, the partial vacuum does not exceed about 50% of the complete vacuum. Optionally, the partial vacuum does not exceed about 40% of the complete vacuum. As a non-limiting example, the partial vacuum is about 10% to about 90% of a complete vacuum, or about 20% to about 70%, or about 30% to about 60% of a complete vacuum. As a non-limiting example, the partial vacuum is about 10% to about 60% o of a complete vacuum, or about 20% to about 50%, or about 30% to about 50% of a complete vacuum. .. Thus, a reduced amount of force is exerted on the fluid sample to minimize sample integrity issues. Optionally, after transporting the sample, the atmosphere is atmospheric pressure. Optionally, after transporting the sample, the atmosphere is some partial vacuum. Optionally, only one of the multiple sample vessels is in partial vacuum, while the others are in higher vacuum levels or full vacuum.

In some embodiments, the cap 1820 can be a closure device having one end inside the sample container and another end outside the sample container, the inner end being the sample container. Has a surface in continuous sealing contact with, inside the end has an annular sleeve extending from the surface towards the closed end, the annular sleeve penetrating the wall of the annular sleeve. It has a first notch that is stretched and parallel to the sample container. In one embodiment, the closure has a recessed ring formed around the first notch inside the edge, and the recessed ring engages the hump of a tubular sample container. It fits.

Optionally, the sample container cap can be formed from a single integrated piece. Alternatively, multiple pieces may be used. The plurality of pieces may be formed from the same substance or different substances. The substance of the cap can be the same as or different from the substance of the sample container body. In one embodiment, the sample container body can be made of an optically permeable material, while the cap is made of an opaque material.

Optionally, the cap 1820 can be detachably engaged with the body. A part of the cap can be inserted into the main body. The cap may include a rim that may rest on the top of the body. This edge is not inserted into the body. In this non-limiting embodiment, the rim can prevent the cap to be prevented from being completely inserted into the body. The edge may form a continuous flange around the cap. In some cases, a portion of the edge can overlap or lie on a portion of the body. A portion of the body may be insertable into a portion of the cap.

Optionally, a portion of the cap that can be inserted into the body may have a rounded bottom. Alternatively, the bottom of the container may have a flat, tapered, curved, curved, or arbitrary shape. The container may include an open end and a closed end. The cap may be formed because it can be easily inserted into the body.

In some cases, a depression may be provided at the top of the cap. The depression may accompany a portion of the cap that is inserted into the body. In some cases, a hollow or recess may be provided within the cap. The depression may have the ability to accept a portion of a channel that can be used to deliver the sample to the container. The depression may help guide the channel to the desired portion of the cap. In one embodiment, the channel can be positioned within the depression before providing fluid communication inside the channel and the sample vessel.

The channel and cap can be pressed together so that the channel penetrates the cap and enters the interior of the vessel, thereby providing fluid communication inside the channel and the sample vessel. In some cases, the cap may have a notch through which the channel passes. Alternatively, the channel can penetrate unobstructed cap material. The channel can be withdrawn from the sample vessel, thereby removing the channel and sample vessel from fluid communication. The cap may have the ability to reseal when the channel is removed. As an example, the cap can be formed from a self-healing substance. In some cases, the cap can have a notch that closes when the channel is removed, thereby forming a liquidtight seal.

In some embodiments, the body may have one or more flanges or other surface features. Examples of surface features may include flanges, ridges, protrusions, grooves, ridges, threads, holes, facets, or any other surface feature. The flange and / or other surface features can surround the body. The flange and / or surface features may be placed on or near the top of the body. The flange and / or other surface features are half from the top, one-third from the top, one-quarter from the top, one-fifth from the top, one-sixth from the top, eight-quarter from the top of the body. Can be placed in one or tenth from the top. The surface features may be useful for the support of the sample container inside the sample collection device. The surface features may be useful for removing the sample container from the sample collection device and / or for placing the sample container within the sample collection device. The flange and / or other surface features may or may not engage with the cap.

Optionally, the cap may have any dimension with respect to the sample container body. In some cases, the cap and / or body may have a similar cross-sectional area. The cap may have the same or substantially similar cross-sectional area and / or shape as the top of the body. In some cases, the cap may have less length than the body. For example, the cap is less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3% or less than 1% of the length of the body. Can have.

With reference to FIGS. 18C-18E, a further embodiment of the sample container 1800 may include a cap holder 1830 that fits onto the cap in order to hold the cap in place. As a non-limiting embodiment, the cap holder 1830 also includes an opening in the cap holder 1830 that allows a member, such as an adapter, to slide through and penetrate the cap 1820. obtain. FIG. 18C shows the portion in the enlarged view.

FIG. 18D shows a cross-sectional view showing an embodiment in which the sample container body 1810 has a cap 1820 covered with a cap holder 1830. As seen in FIG. 18D, the cap holder 1830 has a locking feature 1832 to securely secure the cap holder 1830 to the sample container body 1810 and / or the cap 1820. In one embodiment, the locking feature 1832 comprises an internal ridge that engages one or more ridges 1812 and 1814 on the sample container body 1810. FIG. 18E shows a side view of the cap holder 1830 connected to the container body 1810.

In some cases, the surface (inside and / or outside) of the sample container can be coated and / or treated with a substance. For example, the inner surface of the sample container may be coated with a fixative, antibody, optical coating, anticoagulant, sample additive and / or preservative. These may be the same as or different from any material that coats the inside of the channel. In one non-limiting example, the coating is, but is not limited to, polytetrafluoroethylene, poly-xylene, a polysorbate surfactant (eg, polysorbate 20) or another that treats the surface to reduce surface tension. Can be a substance.

In an embodiment, the sample vessel is a blood coagulation activator (eg, thrombin, silica particles, glass particles), an anti-glycation agent (eg, sodium fluoride), or a gel that promotes the separation of blood cells from plasma. May include. In an example, the sample vessel may contain polyanetol sodium sulphate (SPS), acidic citrate dextrose additive, perchloric acid, or sodium citrate. Some embodiments may include at least one substance in each of the above categories. It should also be understood that, optionally, other additives or substances, especially those that do not interfere with each other in terms of functionality, are not excluded.

Optionally, the coating is applied over the entire inner surface of the sample container. Optionally, some embodiments may apply the coating as a pattern covering the fruit of a selected area of the sample container. Some embodiments may cover the upper internal region of the sample container. Optionally, some may only cover the lower internal area of the sample container. Optionally, some may cover the internal area of the sample container with debris, lanes, or other geometric patterns. Optionally, some embodiments may also cover the surface of the cap, plug, or cover used with the sample container. Some embodiments have a surface on which the sample should be coated, which enters the sample container to provide smooth transport for the sample to move away from the entrance area and towards the site of interest.

Optionally, the coating may be a liquid or dry coating. Some embodiments may have at least one dry coating and at least one liquid coating. In some cases, one or more reagents can be coated on the inner surface of the sample container and dried. The coating may be provided in an alternative moist environment or may be a gel. In some embodiments, a separation gel may be included in the sample container to separate the selected portion of the sample from the other portion of the sample. Some embodiments may include, but are not limited to, serum separation gels or plasma separation gels, such as polyester-based separation gels available from Becton Dickinson.

Optionally, one or more solid substrates may be provided within the sample container. For example, one or more beads or particles may be provided in the sample container. The beads and / or particles may be coated with a reagent or any other substance described herein. The beads and / or particles may have the ability to dissolve in the presence of the sample. The beads and / or particles can be formed by one or more reagents or can be useful for processing the sample. The reagents may be provided in the sample container in the form of a gas. The sample container can be sealed. The sample container is provided before the sample is introduced into the sample container, after the sample is introduced into the sample container, and / or while the sample is introduced into the sample container. It may remain sealed. In one embodiment, the sample container may have a smooth surface and / or a round bottom. This helps minimize stress on the blood sample, especially during centrifugation. Of course, in the alternative embodiment, the bottom of the other shape of the sample container is not excluded.

In an embodiment, the body fluid sample in the sealed sample container can retain the gas dissolved in the body fluid sample, so that the sample stored in the sealed sample container is the body fluid freshly drawn from the subject's body. A sample, or a sample freshly prepared from a different sample (eg, plasma freshly prepared from whole blood), can retain a similar or identical dissolved gas composition. In embodiments, fluid samples in sealed sample containers are at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20%. Dissolved gas for 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours, or 72 hours Can be held over. In such embodiments, the period typically begins at the time the sample is deposited in the sample container or the time the sample container is sealed. To facilitate the storage of the gas dissolved in the body fluid sample, the sample is placed in a sealed sample container at a selected temperature, such as, for example, 20 ° C, 15 ° C, 10 ° C, 4 ° C, or 0. Can be stored at freezing temperatures below ° C. Other temperatures for sample storage are not excluded.

Similarly, in the embodiment, the body fluid sample in the sealed sample container can hold the sample in the body fluid sample, so that the sample stored in the sealed sample container is freshly drawn from the subject's body. A similar or identical sample composition can be retained in a body fluid sample or a sample freshly prepared from a different sample (eg, plasma freshly prepared from whole blood). In embodiments, fluid samples in sealed sample containers are at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20%. Specimens are retained for a period of 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours, or 72 hours. obtain. In such embodiments, the period typically begins at the time the sample is deposited in the sample container or the time the sample container is sealed. To facilitate the storage of the gas dissolved in the body fluid sample, the sample is placed in a sealed sample container at a selected temperature, such as, for example, 20 ° C, 15 ° C, 10 ° C, 4 ° C, or 0. Can be stored at freezing temperatures below ° C. Other temperatures for sample storage are not excluded. Optionally, the sample container can be centrifuged after the sample has been introduced into the container. For example, the sample container is 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 after the sample is introduced into the container. Centrifuges for hours, 2 hours, 4 hours, 8 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 7 days, or 10 days. Centrifugation of the sample container containing the sample facilitates the separation of blood cells from plasma, for example, in the case of whole blood samples, producing plasma and pelletized cells. In some cases, centrifuging the sample increases the stability of one or more samples in blood or plasma.

FIG. 18F further shows that each of the sample containers can have at least one information storage unit associated with the sample container. Optionally, some embodiments are one information storage that carries information about multiple sample containers, especially if all of the sample containers contain samples from the same subject (but not exclusively). Can have a unit. Such an information storage unit may be on a carrier that holds a plurality of sample containers instead of being on the sample container itself.

FIG. 18F shows a bottom-to-top view of one side of the sample container in one non-limiting example, wherein the information storage unit 1860 is: a bar code (eg, 1-D, 2- D, or 3-D), quick response (QR) codes, images, shapes, words, numbers, alphanumeric strings, colors, or any combination thereof, or at least any type of visible information storage unit. There may be one. Others may use information storage units that are not in the visible spectrum. Others may use RFID tags, RF information storage units, IR emission tags, or other markers that are independent of identification by signals sent over the visible spectrum. Of course, the information storage unit 1860 can also be positioned at the top of the sample container. FIG. 18G optionally shows that the information storage unit can also be included on the side surface of the sample container. This can be an addition or alternative to the information storage unit 1860 located on the top or bottom.

In one non-limiting example, an information storage unit 1860 can be used to identify a sample and / or sample type in a sample collection device. Optionally, there may be one or more information storage units per sample container. The information storage unit can also be used on the sample container holder. The information storage unit may identify the sample collection device, one or more individual sample containers within the device, or components of the device. In some cases, the sample collection device, a portion of the sample collection device, and / or the sample container may be transported. In one embodiment, the sample collection device or a portion of the sample collection device may be transported by a delivery service, or any other service described elsewhere herein. The sample container may be delivered so that one or more tests can be performed on the sample.

Optionally, the identification of the sample and / or the identification of the individual who provided the sample can be traced. Non-restrictive examples include personalized information (eg, name, contact information, social security number, birthday, insurance information, billing information, medical history) and other information about who provided the sample. Can be included. In some cases, the type of sample (eg, whole blood, plasma, urine, etc.) can be tracked. Optionally, the type of reagent that the sample will encounter (eg, anticoagulant, label, etc.) can also be tracked. The date and / or time of collection, the status in which the sample was collected, the type of test to be performed on the sample, the settings for the test, the test protocol, insurance information, medical records, or any other type of information. Additional information about the sample collection, such as, is considered.

In at least one or more embodiments described herein, the information storage unit may assist in tracking such information. The information storage unit can be associated with such information. Such information may be stored outside the sample collection device, mounted on the sample collection device, or in any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device with memory. In some cases, the information may be stored on a cloud computing infrastructure. One or more resources for storing the information are distributed wirelessly, etc. to a remote computer processor via the Internet from a remote server on the cloud. In some cases, a peer-to-peer infrastructure may be provided. The information can be stored in the information storage unit itself, associated with an information storage unit elsewhere, or stored in any combination thereof.

Optionally, the information storage unit can provide a unique identification or a high probability of providing a unique identification. In some cases, the information storage unit may have visible components. The information storage unit may be optically detectable. In some cases, the information storage unit may be identifiable using visible light. In some embodiments, the information storage unit is a barcode (eg, 1-D, 2-D, or 3-D), quick response (QR) code, image, shape, words, numbers, alphanumeric characters. It can be a string, a color, or any combination thereof, or any type of visible information storage unit.

In other embodiments, the information storage unit is optically detectable by any other type of radiation. For example, the information storage unit can be detected by any other type of infrared, ultraviolet, or wavelength of the electron spectrum. The information storage unit may use light emission such as fluorescence, chemiluminescence, bioluminescence, or any other type of optical radiation. In some cases, the information storage unit can be a radio transmitter and / or receiver. The information storage unit can be a radio frequency identification (RFID) tag. The information storage unit can be any type of wireless transmitter and / or receiver. The information storage unit may transmit one or more electrical signals. In some cases, GPS or other location signals may be utilized by the information storage unit.

Optionally, the information storage unit may be audio component or acoustic component and / or include them. The information storage unit may generate a recognizable sound to uniquely identify the identified component.

Optionally, the information storage unit may be detectable via an optical detection device. For example, a barcode scanner may have the ability to read the information storage unit. In another embodiment, the ability of a camera (eg, for a still or video image) or other image capture device to capture an image of said information storage unit and analyze that image to determine identification. Can have.

Optionally, the information storage unit may be on the holder of the sample container. In the holder, one or more identifications may be provided. The information storage unit may be placed in the notch. The notch can be on the bottom surface or side surface of the holder. In some embodiments, the holder may include one or more protrusions. The information storage unit may be placed on the protrusion. In some cases, the information storage unit may be provided on the outer surface of the holder. The information storage unit may be provided on the inner surface of the holder as an alternative. The information storage unit can be detected from outside the sample collection device.

In some embodiments, the information storage unit may be on the outer surface of the sample container or on the inner surface of the sample container. The information storage unit can be detected from the outside of the sample container. In some embodiments, the information storage unit may be provided on the bottom surface of the sample container.

In one non-limiting example, the holder may include an optically transparent portion. The optically transparent portion may be on the bottom of the holder or on the side surface of the holder. For example, transparent or translucent windows may be provided. In another embodiment, the optically transmissive portion may be a hole that does not require a window. The optically transmissive portion allows the inner portion of the holder to be visible. The information storage unit is on an optically transparent portion of the outer surface of the holder, on an internal surface of the holder but visible through the optically transparent portion, or on the sample. It may be provided on the outer or inner surface of the container, but on a portion that is visible through an optically transparent portion. In some cases, the information storage unit may be provided on the inner surface of the sample container, but because the sample container is optically permeable, the information storage unit may be the sample container and /. Alternatively, it is visible through an optically transparent portion.

Optionally, the information storage unit is a QR code, barcode, or other optically visible optical information storage unit, such as, but not limited to, visible from the outside of the sample collection device. obtain. The QR code is visible through an optical window, hole, etc. at the bottom of the holder of the sample collection device. The QR code may be provided on the sample collection device holder or on a portion of the sample container visible through the holder. An image capture device such as a camera or scanner can be provided outside the sample container or shipping container and may have the ability to read the QR code.

In some embodiments, a single or multiple QR codes or other information storage units may be provided on the sample collection device. In some cases, each sample container may have at least one information storage unit, such as a QR code associated with it. In one embodiment, for each sample container, at least one window can be provided in the holder, and each window allows the user to see the QR code or other information storage unit. For example, two sample containers can be housed in a holder, each of which has an accompanying information storage unit recognizable from the outside of the holder.

In some embodiments, the information storage unit may be provided in a sample container housed by the holder. Separating the holder from the rest of the sample collection device causes the sample container to be separated from the rest of the sample collection device. The sample container may remain in the holder or may be removed from the holder. The information storage unit may remain with the sample container even if the holder is removed. Alternatively, the information storage unit may remain with the holder even if the sample container is removed. In some cases, both the holder and the sample container can have an information storage unit, so that the sample container and holder can be tracked individually and / or matched when separated. Can be done.

In some cases, any number of sample containers may be provided within the sample collection device. In some embodiments, all of these sample containers can be instantly connected to the sample collection device. Optionally, the sample vessels may be connected sequentially or in other non-simultaneous fashions. The sample container may be capable of receiving a sample received from a subject. Each sample container may optionally have a unique information storage unit. The unique information storage unit can be associated with any information about the sample, subject, device, or component of the device.

In some cases, each information storage unit for each sample container may be unique or may contain unique information. In other embodiments, the information storage unit on the sample container need not be unique. Optionally, some embodiments may have unique information about the device, the subject, and / or the type of sample. In some embodiments, the information on the information storage unit can be used to associate several sample containers with the same subject or the same information.

In some embodiments, in a collection reservation, the information storage unit is attached to or otherwise associated with the sample container or group of sample containers (physical or non-physical, such as a database pointer or concatenation). Accompanying). Where concomitant by a group, the accompaniment may be based on the same user or all from other factors described herein. Optionally, some embodiments may have an information storage unit already on top of the sample container or group of sample containers. In one non-limiting example, the information storage unit then provides identifier information associated with the subject at or near the time of sample collection. In this embodiment, the information on the information storage unit remains the same, but is then linked to the subject. In another embodiment, the information on the information storage unit is modified to include information about the subject. Optionally, some embodiments may have both, some information may be modified and some may not be modified (but then related to other information about the subject or collection event such as date and time) Can be attached).

With reference to FIGS. 19A-19C, various advanced embodiments of the sample collection device will be described. FIG. 19A shows the tip of the sample collection device with openings 1103 and 1105 for each channel. In this embodiment, the openings 1103 and 1105 are arranged very close to each other with a partition wall 1910 between the openings 1103 and 1105. In one non-limiting example, the thickness of the partition wall 1910 is set to the minimum thickness that can be reliably formed throughout the manufacturing process used to form the sample collection device. In one embodiment, the wall thickness should be about 1-10 mm. In some embodiments, instead of being aligned, the openings 1103 and 1105 can be in a top-bottom configuration, diagonal configuration, or other configuration in which the two openings are very close to each other.

With reference to FIG. 19B, this embodiment shows the openings 1910 and 1912 configured coaxially with each other. The coaxial configuration of the openings 1910 and 1912 allows for greater overlap between the two openings.

With reference to FIG. 19C, this embodiment is similar to that of FIG. 19B, except that these openings 1920 and 1922 are circular instead of the squarely shaped openings. Any variety of different shapes, including, but not limited to, circles, ellipses, triangles, rectangles (eg, squares, rectangles, trapezoids), pentagons, hexagons, octagons, or any other cross-sectional shape, Please understand that it can be used. Of course, it should be understood that different shapes can be used for each opening, and that the collector does not have to have the same cross-sectional shape for all openings. Some embodiments may have one cross-sectional shape with respect to the opening, but may have a different cross-sectional shape with respect to channels downstream of the opening.

Single channel sample collector

With reference to FIGS. 20A-20B, said embodiments herein are typically described as sample collection devices with two separate channels, while some embodiments have a single inlet channel. It should be understood that 2010 can be used. This single entrance channel 2010 may or may not be covered. Suitable coatings include, but are not limited to, anticoagulants, plasma, or other substances.

FIG. 20A shows that in the embodiment of the sample collection device 2000, the tissue penetration member 2112 can be coaxially mounted within the single entrance path 2010. This allows the wound to be formed in the target tissue in a manner aligned with the single entrance pathway 2010. The tissue-penetrating member 2012 is, but is not limited to, actuated by pulling a pulling iron, actuating by contact between the tip of the device and the target tissue, or when the device is pressed against the target tissue with sufficient pressure. It can be activated by one of a variety of techniques, such as by pressure. After activation, the tissue penetration member 2012 may remain in the single entrance path 2010. Optionally, the tissue penetrating member 2012 can retreat out of the single entrance path 2010.

The sample fluid entering the sample collection device 2000 may branch from the single inlet path 2010 into two or more separate paths 2014 and 2016. This allows the sample fluid to be split into at least two portions from a sample collected from a single point of contact. The two portions are optionally held in two separate holding chambers 2018 and 2020. Each of these chambers may have one or more adapter channels 2022 and 2024, such as, but not limited to, containers 1146a and 1146b for moving the sample fluid to the container. It should be understood that the holding chambers 2018 and 2020 and / or the containers 1146a and 1146b contain an anticoagulant therein in order to prepare the sample fluid for processing.

With reference to FIG. 20B, in this embodiment, the tissue penetrating member 2012 in the single entrance path 2010 remains in whole or in part in the single entrance path 2010 after activation. It is shown that it is composed of. It should be understood that embodiments may use penetrating members that are not hollow or have a lumen therein.

Yet another embodiment of the sample collection device 2030 will be described with reference to FIG. This embodiment shows a single entrance path 2032 of reduced length with a tissue penetration member 2012 configured to extend outward from the path 2032. After activation, the tissue penetrating member 2012 can be in the path 2032 or, optionally, retracted out of the path 2032. The sample fluid entering the sample collection device 2030 may branch from the single inlet path 2032 into two or more separate paths 2034 and 2036. This allows the sample fluid to be split into at least two portions from a sample collected from a single point of contact. This embodiment shows that the pathways 2034 and 2036 remain in the capillary channel configuration and do not expand into a chamber as in the embodiments of FIGS. 20A-20B. The embodiments herein are one or more filling measuring instruments for the collection path and / or the container on the device so that the user can know when a sufficient filling level is reached. Please understand that it can include.

Due to the small sample volume collected by containers such as containers 1146a and 1146b, but not limited, "pulling" from reduced pressure, such as vacuum pressure in said container, is caused by the sample fluid. It should be understood that in a manner that is being collected, crushing a blood vessel or other lumen, or detrimentally altering its morphology, it is minimally transferred into the subject's body or not. For example, pediatric and geriatric patients typically due to the higher vacuum forces associated with drawing a larger sample volume into a conventional vessel when a conventional large volume vacuum vessel is used. It has small and / or weak veins that can collapse. At least one embodiment of the device does not have this problem because it does not exert a vacuum (suction) force on the veins. In one embodiment, the amount of the vacuum force is about 120 μL of the sample fluid drawn into the container 1146a. Optionally, the amount of the vacuum force is about 100 μL of the sample fluid drawn into the container 1146a. Optionally, the amount of the vacuum force is about 80 μL of the sample fluid drawn into the container 1146a. Optionally, the amount of the vacuum force is about 60 μL of sample fluid drawn into the container 1146a. Optionally, the amount of the vacuum force is about 40 μL of the sample fluid drawn into the container 1146a. Optionally, the amount of the vacuum force is about 20 μL of the sample fluid drawn into the container 1146a. In one embodiment, this type of withdrawal can be performed without the use of a syringe, and is primarily based on a pulling force from the container and some force from the fluid exiting the subject. Optionally, a shaped pathway through the device for withdrawing a sample that has reached the interior of the device reduces the force transferred from the containers 1146a and 1146b to the subject's blood vessels or other body lumens. Can help to get it done. Some embodiments are about three-quarters or less in the small volume vessels listed above to prevent the blood vessels in the subject from collapsing, which minimizes and prevents hemolysis of the sample. Vacuum can be used. Some embodiments use less than about half a vacuum in the small volume vessels listed above to prevent the blood vessels in the subject from collapsing, minimizing and preventing hemolysis of the sample. obtain. Some embodiments minimize and prevent hemolysis of the sample, in order to prevent the blood vessels in the subject from collapsing, in about a quarter or less of the small volume containers listed above. Vacuum can be used. The vacuum in the present specification is a perfect vacuum with respect to atmospheric pressure.

It should be understood that in one embodiment, the cross-sectional area of the chamber in the device is larger than the diameter of the cross-section of the flexible tubing used to draw fluid from the needle and / or subject. This further assists in reducing the transfer of force to the subject. The evacuation from the container draws the liquid sample in the device most quickly, rather than directly pulling the sample in the needle closer to the subject. The longer path buffered by the larger volume chamber in the collection device weakens the subject's vascular pull. In addition, the initial peak force pull is significantly less in small volume vessels than in larger volume vessels, also under vacuum. The duration of the "pull" is also longer to allow a larger amount of sample to be placed in the container. At a smaller volume, a significant portion of the sample to be collected is already in the instrument, and a portion that is withdrawn from a subject that was not already in the instrument before initiating the drawing of the sample is it. Less than.

A sample collection device and yet another embodiment will be described with reference to FIG. This embodiment shows a collection device 2100 having a connector 2102, such as, but not limited to, a luer connector that allows coupling with various sample acquisition devices such as tissue penetration members, needles, and the like. While some luer connectors can use press fit to engage with other connectors, some embodiments of the connector 2102 may include threads to facilitate engagement. FIG. 22 shows, in this current embodiment, a fluid connection such as a flexible tube in which the winged needle 2104 leads, but is not limited to, to the connector 2108 to connect the sample acquisition feature to the sample collection device 2100. It is shown that it is connected to the route 2106. The flexible tubing 2106 allows the needle portion 2104 to be disposed away from the sample collection device 2100 but still operably and fluidly coupled to the sample collection device 2100. This allows greater flexibility with respect to positioning the needle 2104 without also moving the sample collector 2100 to obtain the sample fluid. Optionally, some embodiments may directly couple the tissue penetrating member to the device 2100 without the use of flexible tubing.

At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, which is shown when the sample is inside the collection device, and therefore it. Indicates that it is acceptable to engage with the sample container. Optionally, embodiments without a filling indicator are not excluded. Some embodiments optionally provide one or more vents, such as ports, to allow air to escape when the channels in the collection device are filled with samples. Can have. In most embodiments, the filled sample container is separated from the sample collection device after reaching the desired filling level. Optionally, an additional sample container may be engaged with the sample collection device to collect an additional amount of fluid sample. Optionally, the internal state of the sample vessel is one with reduced pressure, the vessel being configured to draw only a predetermined amount of sample fluid.

FIG. 23 shows an exploded view of one embodiment of the sample collecting device 2100. In this non-limiting embodiment, the portion 1130 may be configured to hold a portion having a container holder 1140 and a sampling device holder 2160. The device 2100 uses the adapter channels 2022 and 2024 to minimize sample loss through the open end before the container in the holder 1140 is engaged to pull out a sample in any container therein. It may include a leak prevention device 2162 that can engage with the open end. In the current embodiment, the anti-leakage device 2162 is configured to cover and move at least two adapter channels 2022 and 2024. The present embodiment of the anti-leakage device 2162 can be moved to allow the adapter channels 2022 and 2024 to engage the container in the holder 1140 while not covering the openings on the adapter channels 2022 and 2020. As such, it is dimensioned.

With reference to FIGS. 24 and 25, one embodiment of the sampling instrument holder 2160 is shown in more detail. FIG. 24 shows a sampling device holder 2160 as an assembled unit. FIG. 25 shows an exploded view of the sampling equipment holder 2160 with the first portion 2164 and the second portion 2166. The adapter channels 2022 and 2024 are also shown as removable from the second portion 2166. Although this embodiment of the sampling instrument holder 2160 is shown as two separate parts, it is understood that some alternative embodiments may configure the sample instrument holder 2160 as a single unified unit. I want to be. Optionally, some embodiments can be calibrated to have three or more portions that are assembled together to form the holder 2160. Optionally, some embodiments may form a separated portion along the vertical axis 2165 or other axis of the holder 2160 instead of along the horizontal axis of the holder 2160, which is shown in FIG. Shown as a separation of.

With reference to FIGS. 26-28, various cross-sectional views of the sample device holder 2160 and embodiments of the device 2100 are shown. FIG. 26 shows cross-sectional views of parts 2164 and 2166. Without being bound by any particular theory, the use of separated portions 2164 and 2166 may be selected, among other things, to simplify the manufacture of various internal channels and chambers in the holder 2160. For example, at least one wall 2167 of the chamber can be formed in the first portion 2164, while a complementary wall 2168 of the chamber can be formed in the second portion 2166. FIG. 27 shows an end view of portion 2166 viewed from top to bottom, where the wall 2168 can be seen from the end view.

A cross-sectional view of the assembled device 2100 will be described with reference to FIG. 28. FIG. 28 shows that samples entering the instrument through connector 2102 enter common chamber 2170 before being guided to the adapter channels 2022 and 2024. From the adapter channels 2022 and 2024, the movement of the holder 1140 in the direction indicated by the arrow 2172 operably fluidly connects the containers 1146a and 1146b to the adapter channels 2022 and 2024 and attaches the sample to the adapter channels 2022 and 2024. Move from channel into container. In this embodiment, the adapter channels 2022 and 1146b have sufficient space to allow movement for the containers 1146a and 1146b to penetrate the adapter channels 2022 and 2024 through the caps of the containers 1146a and 1146b. The 2024 can communicate fluidly with the inside of the containers 1146a and 1146b. Only two sets of containers and adapter channels are shown in this figure, but other configurations with more or fewer sets of containers and adapter channels are with equipment as shown in FIG. 28. It should be understood that it can be configured for use.

Modular sample collection device

With reference to FIGS. 29A-29C, embodiments herein typically describe a sample collection device having an adapter channel for connecting the sample collection channel to the container. It should be understood that embodiments that do not have such a configuration are not excluded.

As a non-limiting example of FIG. 29A, as previously suggested, some embodiments herein may not have separate adapter channels. As used herein, the collection channel 2422 may be directly connected to the container 2446 by means of relative operation between one or both of those elements, indicated by the arrow 2449.

As a non-limiting example of FIG. 29B, one or more adapter channels 2454 may initially be separate elements that are not in direct fluid communication with either the collection channel 2422 or the container 2446. .. In the present specification, the collection channel 2422 is referred to as the collection channel, the adapter channel 2454, in order to generate a fluid path from the collection channel through the one or more adapter channels into the container. , Or by means of relative operation between one or more of the containers 2446 (sequentially or simultaneously).

As a non-limiting example of FIG. 29C, one or more adapter channels 2454 may be the elements that initially communicate with the container 2446. The adapter channel 2454 may not be in direct communication with the interior of the container. In the present specification, in order to generate a fluid path from the collection channel through the one or more adapter channels into the container, the collection channel 2400 refers to one or more of those elements. It may be connected to the container by means of relative movement (sequentially or simultaneously). Some embodiments may have a septum, a sleeve, a sleeve with vents, or a cover 2455 above the end of the collection channel that is engaged with the adapter channel. Initially, the adapter channel 2454 may not be in fluid communication with the interior, but engagement of the various elements may also move the adapter channel 2454 to the interior 2446 of the container. Some embodiments in the specification can have one or more adapter channels, and some embodiments may use adapter channels with pointed ends at both ends of the channel. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed as embracing the complete invention.

It should be understood that any of the embodiments herein may be modified to include the features listed in the description of FIGS. 29A-29C.
Sample processing

In the present embodiment, after the body fluid sample has entered the inside of the sample container 1540, the sample container 1540 in (or optionally removed from) the holder 1542 is the transport container 1500. Is filled inside. In this embodiment, there can be one or more slots sized for the sample container holder 1542, or slots for the sample container in the transport container 1500. As a non-limiting example, they may hold the sample container in an array configuration and oriented vertically or in some other predetermined orientation. It should be understood that some embodiments of the sample container 1540 are configured to hold different amounts of samples in their respective containers. As a non-limiting example, this is based on the amount of vacuum force in each of the sample containers, the amount of samples collected in the sample collection channel of the collection device, and / or other factors. Is controlled. Optionally, different pretreatments, such as, but not limited to, different anticoagulants can also be present in the sample container.

As seen in FIG. 30, the sample container 1540 collects samples at a primary location, such as, but not limited to, a sample collection site. As a non-limiting example, the body fluid sample is then transported in said transport container 1500 to a second location, such as, but not limited to, a receiving site, such as an analytical site. The method of transport may be a courier, mail, or other shipping technique. In many embodiments, the transport can be performed by having yet another container in which the transport container is held. In one embodiment, the sample collection site can be a point of care. Optionally, the sample collection site is a point of service. Optionally, the sample collection site is remote from the sample analysis site.

This embodiment of FIG. 30 shows the collection of body fluid samples from the surface of the subject, while other alternative embodiments are such as by venipuncture to fill the sample container 1540. Collection techniques can be used to collect samples from other areas. Such other collection techniques are not excluded for use in place of or in conjunction with surface collection. Surface collection can be performed on the outer surface of the subject. Optionally, some embodiments may be collected from an accessible surface within said subject. The presence of fluid sample B on these surfaces occurs either spontaneously or through the formation of wounds, or by other techniques for making the fluid surface accessible.

Reference is made to still another embodiment described herein in which body fluid samples can be collected from within the subject, whereas samples pooled on the subject's surface are collected. .. This embodiment of FIG. 31 shows a collection device 1550 with a hypodermic needle 1552 configured to collect body fluid samples, such as, but not limited to, venous blood. In one embodiment, the body fluid sample fills chamber 1554 in the device 1550 when the sample container 1540 can be engaged to pull the sample into each container. Optionally, some embodiments do not have a chamber 1554, but instead have very small empty spaces, paths other than channels, used to direct the sample from the needle 1552 to the sample container 1540. , Or have a tube. For body fluid samples such as blood, the pressure from inside the blood vessel is such that the blood sample can fill the chamber 1554 with some assistance from the collection device without much assistance. It is a thing. Such embodiments may optionally have one or more vents, such as, but not limited to, allowing air to escape when the channels in the collection device are filled with samples. .. Optionally, in some embodiments, instead of a tubing connection to the needle, the needle is firmly or substantially firmly connected to the collecting device, as shown in FIG. 44, directly said. It may have a needle connected to a collecting device 1550. Some embodiments may have removable connections, openable connections, luer connections, threaded connections, or other needle connection techniques developed in the future.

At least some or all of the embodiments indicate, but are not limited to, that the sample is present in the collection device and thus it is acceptable to engage the sample container 1540. It may have a filling indicator such as a viewing window or opening. Optionally, embodiments without a filling indicator are not excluded. The filled sample container 1540 can be removed from the sample collection device after reaching the desired filling level. Optionally, an additional sample container 1540 may be connected to the sample collection device 1550 (or 1530) to collect an additional amount of fluid sample.
Point of Service System With reference to FIG. 32, it should be understood that the processes described herein can be performed using automated techniques. The automated process can be used in an integrated, automated system. In some embodiments, it can be a single instrument having multiple functional components within it, and surrounded by a common enclosure. Treatment techniques and methods for the settling means can be preset. Optionally, it is in the form described in U.S. Patent Application Nos. 13 / 355,458 and 13 / 244,947, both of which, by reference, are incorporated herein by reference in their entirety. It can be based on a protocol or operating procedure that can be changed dynamically as desired.
Point of service system

With reference to FIG. 32, it should be understood that the processes described herein can be performed using automated techniques. The automated process can be used in an integrated, automated system. In some embodiments, this can be in a single device that includes multiple functional components within it and is enclosed by a common enclosure. The treatment technique and method of the settling means can be preset. Optionally, both are in the form described in U.S. Patent Applications 13/355, 458 and 13/244, 947, both of which are incorporated herein by reference in their entirety for all purposes. It can be based on a protocol or procedure that can change dynamically.

In one non-limiting embodiment shown in FIG. 32, an integrated device 2500 may be provided that has a programmable processor 2502 that can be used to control multiple components of the device. For example, in one embodiment, the processor 2502 may control a single or multiple pipette system 2504 that can move in the XY and Z directions, as indicated by arrows 2506 and 2508. The same or different processor may control the other components 2512, 2514, or 2516 in the device. In one embodiment, one of the components 2512, 2514, or 2516 comprises a centrifuge.

As seen in FIG. 32, control by processor 2502 is such that the pipette system 2504 takes a blood sample from the cartridge 2510 and moves the sample to one of the components 2512, 2514, or 2516. Allows you to. Such movement is to dispense the sample into a removable container within the cartridge 2510 and then transport the removable container to one of the components s2512, 2514, or 2516. Including. Optionally, the blood sample is dispensed directly into a container already attached to one of the components 2512, 2514, or 2516. In one non-limiting example, one of these components s2512, 2514, or 2516 is a centrifuge with an imaging configuration that allows both illumination and visualization of the sample in said container. It can be a machine. Other components 2512, 2514, or 2516 perform other analytical, assay, or detection functions.

All of the above can be integrated within a single enclosure 2520 and can be configured for mounting on a tabletop or in a small floor area installation area. In one embodiment, a system mounted on a floor with a small footprint occupies a floor area of ^{about 4 m 2 or less.} In one embodiment, a system mounted on a floor with a small footprint occupies a floor area of ^{about 3 m 2 or less.} In one embodiment, a system mounted on a floor with a small footprint occupies a floor area of ^{about 2 m 2 or less.} In one embodiment, a system mounted on a floor with a small footprint occupies a floor area of ^{about 1 m 2 or less.} In some embodiments, the footprint of the device is approximately 4m ² , 3m ² , 2.5m ² , 2m ² , 1.5m ² , 1m ² , 0.75m ² , 0.5m ² , 0.3m. ² , 0.2m ² , 0.1m ² , 0.08m ² , 0.05m ² , 0.03m ² , 100cm ² , 80cm ² , 70cm ² , 60cm ² , 50cm ² , 40cm ² , 30cm ² , 20cm ² , 15 cm ² , or 10 cm ² . It can be: Some suitable systems, appropriate in the Point of Service setting, are incorporated herein by reference in their entirety, U.S. Patent Application Nos. 13/355, 458 and 13/244, 947. The present embodiment may be configured for use with any of the modules or systems described in those patent applications.

Further embodiments of the sample collection device will be described with reference to FIGS. 33-37. As seen in FIGS. 33 and 34, at least one embodiment increases the cross-sectional area of the channel and then increases the flow velocity in order to provide a capillary channel region and then lower flow resistance. A sample collection area 2600 with a low flow resistance area 2610 is shown. In at least one embodiment, this lower flow resistance region 2610 is still a capillary channel, but has a lower flow resistance. Optionally, other embodiments may increase the size of the place where the sample flows through it, but it is not under capillary action. The increased channel size can also be used to store samples in it. As a non-limiting example, this preservation may be primary during collection, from collection site to refrigeration, from collection site to receiving site, from other location to location, or for other purposes. , Can be for a longer period of time. One embodiment can be configured to have caps on both ends of the instrument so that the sample is contained therein without having to move to containers 1146a and 1146b.

Since the joints between regions 2600 and 2610 can be arranged so as to intersect the median plane 2620, this can also reduce the amount of binding material for binding the elements together. It should be understood that this embodiment may have channels 2612 and 2614 configured to accommodate the same or substantially the same volume in the same cross-sectional size and / or said channel. Optionally, the channels 2612 and 2614 may be configured to hold different volumes. The same is true when the channel continues to enter region 2610. Optionally, some embodiments are the same in region 2600, while when in region 2610 they can have different sizes and vice versa. Configurations of other sizes are not excluded. Although the channel is shown here in a straight line, some embodiments of any of the embodiments disclosed herein have a curved or other non-linear portion of the channel. Understand what you get.

Other parts are similar to those already described herein with respect to the containers 1146a and 1146b, adapter channels, fritz, holder 130 and the like. Capillary suction of both channels at the contacts (both filling times <6 seconds) was improved (step removed) and blood easily entered the channels and passed without the need to tilt the contact area. .. The portion may be formed of PMMA, PET, PETG or the like. In this embodiment, this provides 7.5 times faster filling than a single cross-sectional size capillary channel in order to allow an increase in channel size in region 2610 to allow easier flow into this region. obtain.

As can be seen in the equation below, the flow resistance decreases in region 2610 based on the fourth power of the change in channel size:

It should be appreciated that as soon as the desired amount of sample enters the channel, some embodiments may be configured such that the sample is manipulated to be moved into a storage container. As a non-limiting example, the movement of this sample can be via tensile, pushing, or both. In one embodiment, the tensile force has a container with a vacuum in it, a suction tool, or another movable surface in which the sample can be pulled out by increasing the volume, or active. It can be provided by a container having a target vacuum force. In one embodiment, the pushing force can be pressure from air or other gas, or other fluid population, supplied from behind the bolus. In embodiments, compressed gas, pressure from a cap with a seal around the device passing through the collection device, a syringe connected to one end and applying gas pressure, or the like, to push the gas forward. The power of is demonstrated. The force provided can be different from the driving force for collecting the sample in the channel. Optionally, some embodiments may use different driving forces per channel. Optionally, different driving forces may be used in region 2600 for zone 2610.

Although the teachings have been described and illustrated with reference to that particular embodiment, those skilled in the art will appreciate various adaptations, variations, of procedures and protocols, without departing from the spirit and scope of the invention. You will understand that you can modify, replace, delete, or add. For example, with any of the above embodiments, the fluid sample can be whole blood, diluted blood, interstitial fluid, a sample collected directly from a patient, a surface sample, some pretreated sample, and the like. I want to be understood. Those skilled in the art will appreciate that alternative embodiments may have one or more containers that can be sequentially manipulated to connect with the needle or opening of the channel in order to draw the fluid into the container. Will do. Optionally, some embodiments may have a vessel configured to be operably coupled to said channel simultaneously. Some embodiments use a single instrument, all with a puncture device or other wound making device and sample collection device to bring the target sample fluid to the tissue surface and then collect the sample fluid. Can be integrated with. As a non-limiting example, at the edge of the sample collection device near the sample collection channel opening so that the wound site created can also be on the same side as the collection opening along the edge of the device. A tissue penetrating member, which is spring-operated, mechanically actuated, and / or electromechanically actuated, can be attached to have a penetrating tip that exits from the side. Optionally, the integrated device can have a collection opening on one surface and a tissue penetration element along another surface of the device. In any embodiment disclosed herein, the first opening of the collection channel may have any rounded shape configured to not easily puncture human skin. ..

In addition, the use of warm compresses on the finger or other target tissue increases blood flow to the target area, and thus increases the rate at which sufficient blood or other fluid is withdrawn from the subject. Let me. The heating is used to bring about 40C-50C to the target tissue. Optionally, the heat brings the target tissue to a temperature range of about 44-47C.

In addition, one of ordinary skill in the art will recognize that any embodiment described herein can be applied to the collection of sample fluids from humans, animals, or other subjects. Some embodiments described herein may also be suitable for the collection of non-biological fluid sumps. Some embodiments may use containers that are not removable from the carrier. After measurement in the sample collection portion, some direct the fluid sample to a cartridge that is then placed in the sample or other analytical instrument by the second driving force. Optionally, it should be understood that while many embodiments refer to the container in the carrier, embodiments in which the container is uncovered or not mounted in the carrier are not excluded. Some embodiments may have a container that is separate from the device and that the channel is brought to fluid communication only when the minimum filling level is reached. For example, the container can be held in different locations and is brought into communication by the technician only when there is a sufficient amount of blood or sample fluid in the sample collection device. At that time, the container can be brought into fluid communication simultaneously or sequentially with one or more of the channels of the sample collection device.

In addition, concentrations, quantities, and other numerical data are provided herein in the form of ranges. The form of such a range is used solely for convenience and shortness, and does not include only the numbers explicitly listed as the limits of the range, but all individual numbers, or ranges thereof. It should be understood that the subranges contained in are included as if each numerical value and subrange were explicitly listed. For example, the particle size range from about 1 nm to about 200 nm is not only the explicitly stated range of about 1 nm and about 200 nm, but also individual sizes such as 2 nm, 3 nm, 4 nm, and 10 nm to 50 nm. It should be interpreted to include subranges such as 20 nm to 100 nm.
Transport container

An exploded perspective view of a non-limiting example of the transport container 3200 provided according to the embodiments described herein is shown with reference to FIGS. 38A-38B. It should be understood that the shipping container 3200 may be configured to have any other one or more features described elsewhere herein. As a non-limiting example, the transport container 3200 may be useful for transporting one or more sample containers therein. In some embodiments, the transport container 3200 is thermally, but not limited to, to minimize unwanted thermal degradation of the sample during transport to another location, such as an analytical facility. Provides a controlled internal area. It should be understood that the shipping container may be placed in one or more other containers during shipping.

In one embodiment, the sample container may be provided by a sample collection device that has collected the body fluid sample. As a non-limiting example, the sample container may contain a sample in liquid form therein. In most embodiments, the liquid form may include embodiments that are suspensions.

As a non-limiting example, the shipping container 3200 may have any dimensions. In some cases, the transport container 3200 is about 1 m ³ , 0.5 m ³ , 0.1 m ³ , 0.05 ^{m 3} , 0.01 m ³ , 1000 cm ³ , 500 cm ³ , 300 cm ³ , 200 cm ³ , 150 cm ³ , 100cm ³ , 70cm ³ , 50cm ³ , 30cm ³ , 20cm ³ , 15cm ³ , 10cm ³ , 7cm ³ , 5cm ³ , 3cm ³ , 2cm ³ , 1.5cm ³ , 1cm ³ , 700mm ³ , 500mm ³ , 300mm ³ , It can have a total volume of 100 mm ³ , 50 mm ³ , 30 mm ³ , 10 mm ³ , 5 mm ³ , or 1 mm ^{3 or less.} The installation area and / or maximum cross-sectional area of the transport container is about 1 m ² , 0.5 m ² , 0.1 m ² , 0.05 ^{m 2} , 100 cm ² , 70 cm ² , 50 cm ² , 30 cm ² , 20 cm ² , 15 cm ² , It can be 10 cm ² , 7 cm ² , 5 cm ² , 3 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 70 mm ² , 50 mm ² , 30 mm ² , 10 mm ² , 5 mm ² , or 1 mm ² . In some cases, the transport container is about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.7 cm. , 0.5 cm, 0.3 cm, or 1 mm or less (eg, height, width, length, diagonal, or perimeter). In some cases, the maximum dimensions of the shipping container are about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm. , 0.7 cm, 0.5 cm, 0.3 cm, or less than 1 mm.

Optionally, the shipping container can be lightweight. In some embodiments, the transport container is about 10 kg, 5, kg, 4 kg, 3 kg, 2 kg, 1.5 kg, 1 kg, 0.7 kg, with or without the sample container having a sample therein. 0.5kg, 0.3kg, 100g, 70g, 50g, 30g, 20g, 15g, 10g, 7g, 5g, 3g, 2g, 1g, 500mg, 300mg, 200mg, 100mg, 70mg, 50mg, 30mg, 10mg, 5mg, Or it weighs less than 1 mg.

As seen in FIGS. 38A and 38B, one embodiment of the shipping container includes a top cover 3210, a housing for thermal conditioning equipment 3220, one or more insertion trays 3230a, 3230b for the shipping container, and a bottom plate. Can have 3240.

In one embodiment, the top cover 3210 has a substantially flat shape, but other shapes are not excluded. The top cover 3210 covers, but is not limited to, a thermal control device such as a heater or cooler contained in the shipping container. The top cover may or may not have the same footprint as the housing for the thermal conditioning device 3220. A cooler, heater, or other thermal conditioning device 3220 may be provided within the shipping container 3200. Optionally, the device 3220 can be an active or passive unit. The thermal control device can keep the sample container in the transport container 3200 at a desired temperature, or a temperature lower than a predetermined threshold temperature. Optionally, the thermal control device can be any temperature control unit well known in the art. Optionally, the thermal conditioning device may have the ability to heat and / or cool. Optionally, the thermal conditioning device may be a thermoelectric cooler. Optionally, the thermal conditioning device is wrapped between a top cover and a housing for the cooler.

Optionally, the top cover and the housing may or may not form an airtight seal. The top cover and / or housing is formed from a material with the desired thermal conductivity. For example, the housing 3220 may have selectable thermal conductivity. In one embodiment, the temperature may be substantially uniform everywhere, as it may include a phase change substance (PCM) embedded in the material of the housing box. PCM retains a very good temperature profile. It is desirable that the sample is not supercooled in contact with ice or the like, which causes a temperature drop of up to −5 ° C. The PCM may be configured to control the temperature range above freezing. As a non-limiting example, heat conduction can be in the range of about 100-250 W / m / K (watts / meter / Kelvin). Optionally, each sample container is brought into contact with the PCM. Some embodiments may have PCM in each layer. The PCM material can be flow molded into the shipping container material. Optionally, there may be a chamber for the PCM material. Optionally, the steps in the tray can be filled with PCM. The PCM may provide a passive thermal control technique.

Optionally, the PCM can be incorporated into an injection molded material. In such an embodiment, the entire container can be a cooling medium. This can prevent PCM from leaking from the chamber inside the shipping container. The shipping container size can also shrink when the PCM is directly integrated with the shipping container material. The energy density is higher due to the increased storage capacity per mass. Mixing PCM material and plastic can be configured to have both strength and cooling. As a non-limiting example, for robustness, 30% of the material is PCM, and the rest is plastic. As a non-limiting example, 20% -40% of the material can be PCM, while the rest can be other, but not limited to, plastics for mechanical robustness. Some embodiments may use an outer surface that is hollow molded with PCM or other material. The interior can be formed by different techniques as it is not essential for aesthetic appeal. Optionally, casting or other bass molding processes can also be used in place of or with injection molding of the PCM-integrated shipping container material. The embedded PCM may also be included in the tray. Some embodiments could be much more thermally conductive trays to achieve a more uniform and uniform cooling profile. Optionally, the PCM material is contained in a chamber inside the housing of the shipping container, and the wall of the chamber can be thinner than the wall thickness of other areas of the shipping box housing.

In one embodiment, the transport container 3200 comprises each of the trays 3230a and 3230b configured to be easily readable by any information storage unit of the sample container without removing the sample container from the trays 3230a and 3230b. Can have. In one embodiment, the holder has an opening at the bottom that allows the information storage unit at the bottom to be visible while the sample container is stationary in the trays 3230a and 3230b.

FIG. 39 shows a plurality of figures of the transport container 3200. For some, the sample container holder in the tray 3230a or 3230b may be any information storage unit, such as, but not limited to, a barcode or other information storage unit, from below or from the transport container 3200. Indicates that it has an open bottom so that it can be read from other orientations that are not removed. Optionally, only certain parts of the shipping container 3200, such as, but not limited to, layers, trays, etc., can be removed to obtain the desired information. Optionally, the barcode or other information storage unit may be accessed through one or more openings in the tray. That allows for bar code scanning of very small shipping containers. Optionally, the rows of sample containers can be scanned individually or the entire tray can be scanned at the same time. Optionally, the user can see all of the sample container holders. Optionally, a computer vision system can also scan to see if steps such as centrifugation have been completed. This can be done at any end of the shipping process. The computer vision system can visualize the sample container and determine if the sample there is in a form in which the desired step has been completed. If it detects an error, the system notifies the user or the system of the problem and / or re-performs steps that have not been and / or were improperly performed. Optionally, the holder has a closed end, and information can be on the side or other surface of the shipping container 3200.

In some embodiments, the shape of the holder may be designed to follow the contour of the sample container 3134 therein in order to increase surface area contact and improve the thermal control of the sample container. Optionally, thermal control of the sample vessel can occur through thermal transfer with the tray and / or the PCM, but not in direct contact with the PCM. Optionally, some sample vessels 3134 could also be in direct contact with the vessel and / or the PCM. The opening for the sample container and / or the holder can be in a linear row, in a honeycomb pattern, or in another pattern.

A fully assembled shipping container 3200 is shown with reference to FIGS. 40A and 40B. FIG. 40B shows a plurality of sample containers 3134, such as those attached to the sample collection device. All of the sample containers 3134 can be from samples associated with one subject, and an information storage unit associated with tray 3230 can be used to provide information about this group of samples. .. Optionally, each of the individual sample containers may still have an information storage unit that is the same as or unique to that of tray 3230a. In some embodiments, sample containers from multiple subjects may be inserted into the same tray 3230a. Optionally, some can only partially fill their respective trays. Each opening in the tray can be filled, but not all sample containers have a sample in it (ie, some are inserted to provide a uniform thermal profile. Can be an empty sample container). These stackable trays 3230a may have closure devices that use elements that connect the trays to each other, such as, but not limited to, magnets, mechanical latches, or other coupling mechanisms. In some embodiments, magnets may be used to engage the tray holding the sample container to allow easy opening during filling and removal automation. Optionally, the user cannot remove the tray from the shipping container. Optionally, the user cannot remove the tray from the shipping container without using a tool to release the tray. Some embodiments have a locking mechanism (magnetic or other technique). Thus, the patient service center can put the sample in but not take it out. Optionally, some embodiments may have selected shaped openings to prevent errors and may misplace the sample containers and / or their holders. Can not.

In one embodiment, the filling and / or removal may be performed in a temperature controlled chamber or chamber to keep the sample in the desired temperature range. In one embodiment, it is desirable to have a temperature range of about 1 ° C. to 10 ° C. Optionally, it is desirable to have a temperature range of about 2 ° C to 8 ° C. Optionally, it is desirable to have a temperature range of about 4 ° C to 5 ° C. Optionally, the materials in the trays 230a and 230b can be used to provide a thermally controlled atmosphere for the sample container. In some cases, convection may be used to control the thermal profile inside the shipping container 200.

FIG. 40B also shows that in this particular embodiment there may be an O-ring or other sealing groove 3232 that provides a tight connection between the layers of the shipping vessel. The system may also include a closing mechanism 3234, such as a magnetic closing device, to keep the stackable insertion tray in the desired position. It should be appreciated that some embodiments may have through holes 3236 for wiring sensors to detect the conditions experienced by the stackable insert trays during shipping.

40C is a different perspective view of the embodiments of FIGS. 40A and 40B when various components, such as the stackable trays and lids, are combined together to form the shipping container 3200. Is shown. As seen in FIG. 40C, the shipping container may be contained within a sample container or multiple layers of trays with sample containers. Optionally, some embodiments may have only a single layer of sample container. Some embodiments may use active cooling or thermal control within one or more layers of said transport container 3200. As a non-limiting example, one embodiment may have a thermoelectric cooler at the top layer. Optionally, some embodiments may use a combination of active and passive theoretical controls. As a non-limiting example, one embodiment may have a thermal mass, such as, but not limited to, a phase change material (PCM) that is already at the desired temperature. An active thermal control unit may be included to keep the PCM in the desired temperature range. Optionally, some embodiments may use only thermal mass, such as, but not limited to, to keep the temperature in the desired range.

Transport container with removable tray

Here, with reference to FIG. 41, still another embodiment of the shipping container will be described. FIG. 41 shows a transport container 3300 having a thermally controlled internal 3302 containing a tray 3304 capable of holding a plurality of sample containers 3306 in any configuration, each of which is a large sample of the container 3306. The portions are held in a free-flowing, non-absorbed form by capillaries, in which less than about 1 ml of sample fluid is in each container. Optionally, in each container is a sample fluid of about 2 ml or less. Optionally, in each container is a sample fluid of about 3 ml or less. In one non-limiting example, the containers are arranged such that there are at least two containers in each transport container with sample fluid from the same subject, and in the matrix at least the first sample , Contains a first anticoagulant, and a second sample contains a second anticoagulant.

FIG. 41 shows that the sample container 3306 is held in an array configuration, but other predetermined configurations are not excluded. Some may be placed in other holding mechanisms connected by the sample container hinges, swinging or allowing one or two degrees of freedom in operation. In some embodiments, the sample container can be placed in a device having the first configuration during filling. And then take a second configuration to hold the sample container during transport. Some embodiments have a second property, such as having the first material property during filling of the sample container, and then curing, but not limited to, during transportation of the sample container. Can be placed in the material.

In some embodiments, the sample container is in a holder 3310, and the tray 3304 is an opening and / or cavity sized to fit into the holder 3310 rather than the sample container. To define. As a non-limiting example, the holder 3310 can be used to physically hold the accompanying container 3306 together while in the tray 3304. Since some embodiments have the holder 3310 in direct contact with the tray 3304, the container is protected from direct contact with the tray 3304. In one non-limiting example, the tray may hold at least 100 containers, or optionally 50 holders, each with at least 2 containers.

Further referring to FIG. 41, this embodiment of the transport container 3300 may have several holding mechanisms 3320 for holding the tray 3306, such as, but not limited to, clips, magnetic regions, and the like. The holding mechanism 3320 may be configured to hold the tray 3304 in a releasable manner when desired. Optionally, the holding mechanism 3320 may be configured to hold the tray 3304 in a non-releaseable manner. In the embodiment shown in FIG. 41, the holding mechanism 3320 is shown as a magnetic and / or metal member in tray 3304 that is attracted to a metal and / or magnetic member in the transport container 3300. ing. When the transport container 3300 arrives at the processing facility, the tray 3304 may be configured to be removed from the transport container 3300. This can be done by using one or more techniques, such as, but not limited to, using strong magnets that engage magnetic and / or metal members in the tray 3304. In some embodiments, a grip, hook, or other mechanical mechanism may be used to remove the tray 3304 from the shipping container 3300. In some embodiments, a combination of techniques may be used to remove the tray 3304. Some embodiments choose to remove the container 3306 and / or the holder 3310 while the tray 3304 is in the shipping container 3300. Some techniques may perform more than one of the aforementioned techniques.

It should also be understood that the transport container 3300 itself can be a cooling device containing, but not limited to, thermal control substances such as ice, PCM. In other embodiments, the thermal control material may be integrated directly into the material forming the transport container 3300. As seen in FIG. 41, some embodiments of the transport container 3300 are substantially empty in which one or more of the thermal control substances are housed or integrated therein. Space 3324 may be provided.

Further referring to FIG. 41, the transport container 3300 is for attaching the cover to another layer of the transport container 3300, for facilitating illustration, the cover and / or connection to the cover, or other. The layers are not shown in FIG. It should be understood that some embodiments use only a single layer, but multi-layer embodiments are not excluded.

A exploded perspective view of yet another embodiment of the transport container 3400 will be described with reference to FIG. 42. The embodiment of FIG. 42 is designed to hold the tray 3402 inside the transport container internal 3404. The exploded perspective view shows a plurality of containers 3406 in holder 3410 in tray 3402. The tray 3402 may be configured to have some or all of the holding mechanisms 3420 similar to the holding mechanism 3320 in the tray 3402. It is understood that the tray 3402 may have one or more notches, protrusions, or features to allow the tray 3402 to be inserted into a limited number of predetermined orientations. I want to. Some embodiments may be configured to allow only one orientation of the tray in the container. Some embodiments may be configured to allow only two possible orientations of the tray within the container.

FIG. 42 shows that in one embodiment, the transport container 3400 can be formed from two separate pieces 3430 and 3432. Optionally, some embodiments may be formed from three or more pieces. Optionally, some embodiments can be a single piece. The pieces 3430 and 3432 may have openings filled with plugs 3434 and 3436. The interior 3438 of the transport container 3400 may retain, but is not limited to, thermal control substances such as ice and phase change substances. In another embodiment, the thermal control material may be integrated directly into the material used for the transport container 3400.

In one example, the interior 3433 of the piece 3432 may be filled with, but not limited to, a thermal control material such as PCM. Optionally, one embodiment could use an active thermal control material, such as, but not limited to, a thermoelectric cooler to cool the interior.

Still another embodiment of the transport container 3500 is described with reference to FIG. 43. FIG. 43 shows that the transport container 3500 may include a lid 3502 for covering features and / or a sample container therein. In some embodiments, the lid 3502 may contain a thermal insulating material. Optionally, the lid 3502 may include a thermal control unit that helps keep the interior of the transport container 3500 in the desired temperature range. Optionally, the lid is such that some embodiments are useful thermal conductors to keep the interior of the transport vessel 3500 within the desired temperature range via heat transfer from an external thermal control source. Can be configured. As a non-limiting example, the thermal control source can be a cooling source, a heating source, a thermoelectric heat exchanger, or other thermal control device. It should also be appreciated that similar thermal control sources, such as, but not limited to, PCM, or active cooling equipment, may be included within the empty space 3514 below the layer 3516.

The holding holders 3310, 3410, or said features 3512 of other shaped holders for the container, may be in pieces separated from the shipping container, or they may be inside the shipping container. Please understand that it can be formed as one. Optionally, the feature 3512 can be part of such trays of trays 3302 and 3402, as shown in FIGS. 41 and 42. Such trays may be fixed to the shipping container 3500 or may be removable. The holding mechanism 3520 may also be integrated into the tray to allow it to be held in the correct position during transport.

Sample collection and transportation

In embodiments, what is provided herein is a system and method for collecting or transporting a small volume of body fluid sample.

In an embodiment, a sample container containing a small volume of body fluid sample can be transported. The sample and sample container may have any of the properties described elsewhere herein. In embodiments, the sample container is 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. The following body fluid samples may be included. In the embodiment, the sample container is 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. It can have the following internal volumes: In the embodiment, the sample container is 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. It has the following internal volumes and is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99%, or 100%. It may contain a body fluid sample that can fill the internal volume of the container. In embodiments, the sample container may be sealed by, for example, a cap, lid, or membrane. Any internal or sample dimensions of the container described herein may be applied to the internal dimensions of the sealed sample container, or the dimensions of the sample therein, respectively. In the embodiment, the sealed sample container is 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl. , Or have an internal volume of 5 μl or less, which is 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, 5 μl, At least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90 so that 4 μl, 3 μl, 2 μl, or 1 μl of air is present inside the sealed container. You may have a body fluid sample that fills the internal volume of the container at%, 95%, 98%, 99%, or 100%. Thus, for example, a sealed sample container can have an internal volume of 300 μl or less, and it is at least 30 μl of the internal volume of the container such that 30 μl of air is present in the internal volume of the sealed container. It may include a body fluid sample that fills 90%. In another embodiment, the sealed sample container can have an internal volume of 500 μl or less, which is such that 100 μl of air is present in the internal volume of the sealed container. Can include body fluid samples that satisfy at least 80% of. In another embodiment, the sealed sample container can have an internal volume of 150 μl or less, which is such that 3 μl of air is present in the internal volume of the sealed container. Can include body fluid samples that satisfy at least 98% of.

In embodiments, the sample container containing the sample may also contain an anticoagulant. The anticoagulant can be dissolved in the sample or otherwise present in the container (eg, dried on one or more internal surfaces of the container, or the bottom of the container. Present in solid form). The sample container containing the sample can have a "total anticoagulant content", wherein the total anticoagulant content is the total amount of anticoagulants present in the internal volume of the container. , And the anticoagulant (if present) dissolved in the sample, as well as the anticoagulant (if present) in the container that is not dissolved in the sample. In embodiments, the sample container containing the samples has a total anticoagulant content of less than 1 ml of sample and less than 3 mg of EDTA, and a total anticoagulant content of less than 750 μl of sample and less than 2.3 mg of EDTA. Can have a total anticoagulant content of less than 500 μl of sample and less than 1.5 mg of EDTA, less than 400 μl of sample and less than 1.2 mg of total anticoagulant content of EDTA. Can have a total anticoagulant content of less than 300 μl of sample and less than 0.9 mg of EDTA, less than 200 μl of sample and less than 0.6 mg of EDTA total anticoagulant content. Can have a total anticoagulant content of less than 150 μl of sample and less than 0.4 mg of EDTA, less than 100 μl of sample and less than 0.3 mg of total anticoagulant content of EDTA. Can have a total anticoagulant content of less than 75 μl of sample and less than 0.23 mg of EDTA, less than 50 μl of sample and less than 0.15 mg of total anticoagulant content of EDTA. Can have a total anticoagulant content of less than 40 μl of sample and less than 0.12 mg of EDTA, less than 30 μl of sample and less than 0.09 mg of total anticoagulant content of EDTA. Can have less than 20 μl of sample and less than 0.06 mg of EDTA total anti-coagulant content, less than 10 μl of sample and less than 0.03 mg of EDTA total anti-coagulant content. Or can have a sample of less than 5 μl and a total anticoagulant content of less than 0.015 mg of EDTA. In embodiments, the sample container containing the samples can contain less than 1 ml of samples and have a total anticoagulant content of less than 2 mg of EDTA, containing less than 750 μl of samples and less than 1.5 mg of EDTA. Can have total anticoagulant content, can have less than 500 μl of sample and can have less than 1.0 mg of EDTA total anticoagulant content, can contain less than 400 μl of sample and 0.8 mg Can have a total anticoagulant content of less than EDTA and contains less than 300 μl of sample and can have a total anticoagulant content of less than 0.6 mg of EDTA and contains less than 200 μl of sample. And can have a total anticoagulant content of less than 0.4 mg of EDTA, can contain less than 150 μl of sample and can have a total anticoagulant content of less than 0.3 mg of EDTA, less than 100 μl. Can have a total anticoagulant content of less than 0.2 mg of EDTA, can contain less than 75 μl of sample and have a total anticoagulant content of less than 0.15 mg of EDTA. Can contain less than 50 μl of sample and have a total anticoagulant content of less than 0.1 mg of EDTA, contain less than 40 μl of sample and have a total anticoagulant content of less than 0.08 mg of EDTA. Can have less than 30 μl of sample and less than 0.06 mg of EDTA total anticoagulant content, can have less than 20 μl of sample and less than 0.04 mg of EDTA total anticoagulant. Can have a blood agent content and can contain less than 10 μl of sample and have a total anticoagulant content of less than 0.02 mg of EDTA, or can have less than 5 μl of sample and less than 0.01 mg of EDTA. Can have a total anticoagulant content of. In embodiments, the sample container containing the sample can have a total anticoagulant content of less than 1 ml of sample and less than 30 US Pharmacy (USP) units of heparin, less than 750 μl of sample and less than 23 USP units. Can have a total anticoagulant content of heparin and can have a total anticoagulant content of less than 500 μl and less than 15 USP units of heparin and can have a total anticoagulant content of less than 400 μl and less than 12 USP units of heparin. Can have total anticoagulant content and can have total anticoagulant content of less than 300 μl of sample and less than 9 USP units of heparin, can have less than 200 μl of sample and less than 6 USP units of heparin total anticoagulant Can have a blood clotting agent content and can have a total anticoagulant content of less than 150 μl of sample and less than 4.5 USP units of heparin, can have less than 100 μl of sample and less than 3 USP units of total anti-heparin Can have a blood clotting agent content and can have a total anticoagulant content of less than 750 μl of sample and less than 2.3 USP units of heparin, less than 50 μl of sample and less than 1.5 USP units of heparin. Can have total anticoagulant content, less than 40 μl samples and less than 1.2 USP units of heparin total anticoagulant content, less than 30 μl samples and less than 0.9 USP units Can have a total anticoagulant content of heparin, less than 20 μl samples and can have a total anticoagulant content of less than 0.6 USP units, less than 10 μl samples and 0.3 USP units It can have a total anticoagulant content of less than 5 μl of heparin, or it can have a sample of less than 5 μl and a total anticoagulant content of less than 0.15 USP units of heparin. In embodiments, the sample container containing the samples can contain less than 1 ml of samples and have a total anticoagulant content of 15 USP units of heparin, contain less than 750 μl of samples, and 11 USP units of heparin. It can have a total anticoagulant content and contains less than 500 μl of sample, and can have a total anticoagulant content of 7.5 USP units of heparin, contains less than 400 μl of sample, and 6 USP. Can have a total anticoagulant content of unit heparin and contain less than 300 μl of sample, and can have a total anticoagulant content of 4.5 USP units of heparin and contain less than 200 μl of sample. Contains and can have a total anticoagulant content of 3 USP units of heparin, can contain less than 150 μl of sample, and can have a total anticoagulant content of a few USP units of heparin, 100 μl. Can contain less than 75 μl of sample and have a total anticoagulant content of 1.5 USP units of heparin, and contain less than 75 μl of heparin total anticoagulant content of 1.2 USP units. Can have less than 50 μl of sample and can have a total anticoagulant content of 0.75 USP units of heparin, can contain less than 40 μl of sample, and contain 0.6 USP units of total heparin resistance It can have a blood clotting agent content and contains less than 30 μl of sample, and can have a total anti-coagulant content of 0.45 USP units of heparin, contains less than 20 μl of sample, and 0.3 USP. Can have a total anticoagulant content of unit heparin, can contain less than 10 μl of sample, and can have a total anticoagulant content of 0.15 USP units of heparin, or less than 5 μl. Samples can be included and have a total anticoagulant content of 0.08 USP units of heparin.

In embodiments, sample containers containing two or more samples from a single subject can be obtained or transported. When two or more sample containers containing samples from a single subject are obtained or transported, the two or more sample containers contain or do not contain samples from other subjects. In, it can be stored or transported. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample containers containing samples from a single subject can be obtained or transported. In embodiments, less than 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample containers containing samples from a single subject can be obtained or transported. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, or 9 sample containers and 3, 4, 5, 6, 7, 8, 9, or 10 include samples from a single subject. Less than a few sample containers can be obtained or shipped. In an embodiment comprising two or more sample containers, including samples from a single subject, the samples in each sample container can be obtained from the subject simultaneously or at different times. In some embodiments comprising two or more sample containers, including samples from the same subject, the sample in each sample container may be from the same location or source site as the subject. .. For example, two sample containers containing whole blood from the same subject can be obtained, both sample containers containing whole blood from the same fingertip puncture. In other embodiments comprising two or more sample containers, including samples from the same subject, the sample in each sample container may be from a site / source different from that of the subject. For example, two sample containers containing whole blood from the same subject can be obtained, the sample container containing whole blood from the first fingertip puncture site (eg, above the first finger), and the first. The second sample container contains whole blood from the second fingertip puncture site (eg, above the second finger). In an embodiment comprising two or more sample containers containing samples from the same subject, the two or more sample containers may contain different types of anticoagulants or other blood additives. For example, the first sample container can contain whole blood containing EDTA, and the second sample container can contain whole blood containing heparin, the plurality of samples from the same subject. is there. In another embodiment, the first and second sample containers can contain whole blood containing EDTA, and the third sample container can contain whole blood containing heparin, said plurality of samples. It can be from the same subject. In another example, the first sample container can contain whole blood containing EDTA, the second sample container can contain whole blood containing heparin, and the third sample container sodium citrate. Can include whole blood containing, said multiple samples can be from the same subject. In an embodiment comprising two or more sample containers containing samples from the same subject, the two or more sample containers may contain different types of samples from said subject. For example, the first sample container can contain whole blood, and the second sample container can contain plasma from the same subject. In another example, the first sample container can contain whole blood, and the second sample container can contain urine from the same subject. In another embodiment, the first and second sample vessels can contain whole blood, and the third sample vessel can contain saliva from the same subject.

In the systems and methods provided herein, the total volume of body fluid samples can be obtained from the subject. The total volume of the body fluid sample is transferred into a single sample container or into two or more sample containers. For example, a total volume of 500 microliters of body fluid sample can be obtained from the subject, and it can be transferred into a single sample container, the single sample container having a maximum of 600 microliters. Has an internal volume. In another embodiment, a total volume of 500 microliters of body fluid sample can be obtained from the subject, and it can be transferred into two sample containers, each sample container of 300 microliters. It has the maximum internal volume. In another embodiment, a total volume of 500 microliters of body fluid sample can be obtained from the subject, and it can be transferred into two sample containers, one sample container of 400 microliters. It has an internal volume and one sample container has a maximum internal volume of 100 microliters. In the systems and methods provided herein, 5 mL, 4 mL, 3 mL, 2 mL, 1.5 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 150 μL, 100 μL, 75 μL, 50 μL, 40 μL, 30 μL, 20 μL, A total volume of 10 μL, 5 μL or 1 μL or less of body fluid sample can be obtained from the subject. The total volume of body fluid samples from said subjects is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more sample containers, as described elsewhere herein. Can be split between. When the total volume of a body fluid sample from a subject is divided into two or more sample containers, the portion of said total volume of the body fluid sample in several different or all sample containers will have different anticoagulants. May include agents or other additives. For example, a total volume of 500 microliters of body fluid sample can be obtained from the subject, and it can be transferred into two sample containers, one sample container being 250 of the body fluid sample containing EDTA. Contains microliters, and one sample container contains 250 microliters of the body fluid sample containing heparin. Typically, as used herein, the total volume of a body fluid sample refers to a single type of body fluid sample-eg, whole blood or urine or saliva.

In an embodiment, the sample container containing whole blood is centrifuged before storage or shipping so that the whole blood is separated into plasma and pelletized cells in the sample container before shipping. Be separated. In other embodiments, the sample container containing whole blood is not centrifuged prior to storage or shipping.

In some embodiments of the systems and methods provided herein, fluid samples are dried after they have been collected and before they are shipped. In embodiments, the dried sample can be reconstituted into a liquid form at a later point in time, such as during analysis or processing of the sample.

In some embodiments of the systems and methods provided herein, the sample container may be transported from a first location to a second location. The first location can be the location where the sample is collected from the subject, and the second location can be the location where one or more steps are performed to process or analyze the sample. The sample and sample container may have any of the above-mentioned properties described elsewhere herein. For example, the sample may be in a liquid, in a non-matrixed state, in a form that is not absorbed by the capillaries. The sample container may be described herein or transported in a shipping container of other construction. For example, in some optional embodiments, the sample container may be transported in a bag, pouch, envelope, box, capsule, or other structure. In embodiments, the first and second locations can be within the same room, building, campus, or collection of buildings. In embodiments, the first and second locations are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, It can be 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers away. In embodiments, the first and second locations are 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers. , 100 kilometers, 500 kilometers, or less than 1000 kilometers apart. In embodiments, the first and second locations are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers, and 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, It can be 100 kilometers, 500 kilometers, or less than 1000 kilometers away. In an embodiment where the first location is where the sample is obtained from the subject, the sample container moves from the first location to the second location for 48 hours, 36 hours, 24 hours of collecting the sample from the subject. It can be transported within hours, 12 hours, 8 hours, 6 hours, 4 hours, 3 hours, 2 hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute, or 30 seconds.

As used herein, a "sample receiving site" is where the transported sample can be received, and one or more steps are performed on the sample. For example, a sample arriving at a sample receiving site can be processed, analyzed, or handled at the sample receiving site, eg, as part of an inspection or test of the sample. Samples can be transported, for example, in any container or device described herein. In embodiments, the sample receiving site can include one or more sample processing instruments used to process or analyze the sample. Sample processing equipment is described, for example, in U.S. Patent Application No. 13 / 244,947 or any other document, filed September 26, 2011, cited and incorporated elsewhere herein. It can be like that. During the transportation of the sample from the sample collection site to the sample receiving site, the sample may pass through any location. In embodiments, the first location may be a sample collection site and the second location may be a sample receiving site.

An embodiment of body fluid sample collection and transport is described with reference to FIG. FIG. 44 shows a body fluid sample B on the skin surface of the subject. In the non-limiting example of FIG. 44, the body fluid sample B can be collected by one of a variety of instruments. As a non-limiting example, the collection device 3530 is incorporated herein by reference in its entirety for all purposes, without limitation, US Provisional Patent Application No. 61 / filed September 6, 2012. It may be the one described in No. 697, 797. In this embodiment, the body fluid sample B is collected by one or more capillary channels and then directed into a sample container 3540. As a non-limiting example, at least one of the sample vessels 3540 may initially have an interior under partial vacuum used to draw a bodily fluid sample into the sample vessel 3540. In some embodiments, samples can be withdrawn from the sample collection device into the sample container 3540 and from the same or different collection channels in the sample collection device at the same time. Optionally, in some embodiments, the sample can be withdrawn into the sample container at the same time.

In the present embodiment, after the body fluid sample has entered the inside of the sample container 3540, the sample container 3540 (or optionally removed from the holder 3542) in those holders 3542 is said to be transported. It is filled in a container 3500. In this embodiment, there may be one or more slots sized for the sample container holder 3542, or slots for the sample container in the transport container 3500. As a non-limiting example, they may hold the sample container in a vertically oriented array configuration or in some other predetermined orientation. It should be appreciated that some embodiments of the sample container 3540 are configured to hold different amounts of samples in their respective containers. As a non-limiting example, this can be controlled based on the amount of vacuum force in the sample container, the amount of sample collected in the sample collection channel of the collection device, and / or other factors. it can. Optionally, different pretreatments, such as, but not limited to, different anticoagulants may be present in the sample container.

As seen in FIG. 44, the sample container 3540 collects samples at a primary location, such as, but not limited to, a sample collection site. As a non-limiting example, the body fluid sample is then transported in the shipping vessel at 3500 to a second location, such as, but not limited to, a receiving site, but not limited. The method of transport may be a courier, mail, or other shipping technique. In many embodiments, the transport can be performed by having yet another container in which the transport container is held. In one embodiment, the sample collection site can be a point of care. Optionally, the sample collection site is a point of service. Optionally, the sample collection site is remote from the sample analysis site.

This embodiment of FIG. 44 shows the collection of body fluid samples from the surface of the subject, while other alternative embodiments are such as by venipuncture to fill the sample container 3540. Collection techniques can be used to collect samples from other areas. Such other collection techniques are not excluded for use in place of or in conjunction with surface collection. Surface collection can be performed on the outer surface of the subject. Optionally, some embodiments may be collected from an accessible surface within said subject. The presence of fluid sample B on these surfaces occurs either spontaneously or through the formation of wounds, or by other techniques for making the fluid surface accessible.

Refer to FIG. 45 to describe yet another embodiment described herein that collects samples pooled on the subject's surface, whereas body fluid samples can be collected from within the subject. .. In FIG. 31, this embodiment shows a collection device 3550 with a hypodermic needle 3552 configured to collect body fluid samples, such as, but not limited to, venous blood. In one embodiment, the body fluid sample fills chamber 3554 in the device 3550 when the sample container 3540 can be engaged to pull the sample into each container. Optionally, some embodiments do not have a chamber 3554, but instead have a very small empty space, path other than the channel, used to direct the sample from the needle 3552 to the sample container 3540. , Or have a tube. For body fluid samples such as blood, the pressure from inside the blood vessel is such that the blood sample can fill the chamber 3554 with some assistance from the collection device without much assistance. It is a thing. Such embodiments may optionally have one or more vents, such as, but not limited to, allowing air to escape when the channels in the collection device are filled with samples. ..

At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, which is shown when the sample is inside the collection device, and therefore it. Indicates that it is acceptable to engage with the sample container. Optionally, embodiments without a filling indicator are not excluded. Some of the filled sample containers can be removed from the sample collection device after reaching the desired filling level. Optionally, an additional sample container 3540 may be engaged with the sample collection device 3550 (or 530) to collect an additional amount of fluid sample.

FIG. 46 shows a further embodiment of the sample collection device 3570. This embodiment described herein has a tissue penetrating portion 357 such as a hypodermic needle having a handling portion 3574, but not limited to. The handling portion 3574 may facilitate the more accurate entry of the tissue penetrating portion 3572 into the earlier patient at the desired addition and location. In this embodiment, the sample collection container 3540 is in a carrier 3576 that is not in direct physical contact with the tissue penetrating portion 3572. A fluid connection path 3578, such as, but not limited to, a flexible tube, can be used to connect the tissue penetration portion 357 to the sample collection container 3540. In some embodiments, under user control, the sample container 3540 can be configured to slide so that only fluid communication with the tissue penetrating portion 357 is possible. At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, which is shown when the sample is inside the collection device, and therefore it. Indicates that it is acceptable to engage with the sample container 3540. Optionally, embodiments without a filling indicator are not excluded. Some embodiments optionally provide one or more vents, such as ports, to allow air to escape when the channels in the collection device are filled with samples. Can have. In most embodiments, the filled sample container 3540 is separated from the sample collection device after reaching the desired filling level. Optionally, an additional sample container 3540 may be engaged with the sample collection device 3570 to collect an additional amount of fluid sample. Optionally, the internal state of the sample vessel is one with reduced pressure, the vessel being configured to draw only a predetermined amount of sample fluid.
Sample processing

FIG. 47 shows a system diagram of the transport container 3500 whose contents have been removed by the removal assembly 3600 after arriving at the destination. In one embodiment, after the lid 3502 is positioned in the open position, the sample container in the container 3500 can be removed from it. As a non-limiting example, the removal can occur by removing the entire tray of the sample container, removing the holder of the multi-sample container from the tray, and / or removing the sample container individually. Some embodiments are robots for removing the sample container from the transport container 3500, which can move vertically as indicated by arrow 3604 and / or horizontally along the gantry 3608 as indicated by arrow 3606. A controlled structure 3602 can be used. A programmable process 3610 may be used to control the location of the structure 3602, which is used to manipulate the sample container. In one embodiment, the structure 3602 includes a magnet for engaging the holding mechanism to remove the tray from the structure 3602. Robotic arms and / or other types of programmable operations and other embodiments using them can be configured for use herein and are not excluded.

In an embodiment, when the sample container containing the sample arrives at a site for processing or analysis of the sample, the sample can be removed from the sample container. The sample vessel can be processed (eg, shaken, rotated, mixed, or centrifuged before the sample is removed from the sample vessel). Samples are such as suction (eg, by a fluid handling system or pipette), pouring, or mechanical force (eg, forcing the sample from the container by reducing the size of the internal region of the sample container). , Can be removed from the sample container by any suitable mechanism. In an embodiment, when the sample is removed from the sample container, only a poor sample or no sample remains in the container (eg, as a mechanical / mobile loss). For example, after removing the sample from the container, 50 μl, 40 μl, 30 μl, 20 μl, 15 μl, 10 μl, 5 μl, 4 μl, 3 μl, 2 μl, 1 μl or less, or 0 μl of the sample may remain in the sample container.

As a non-limiting example, the sample in said sample container is then filed September 26, 2011, which is incorporated herein by reference in its entirety, U.S. Patent Application No. 13 /. It can be processed using a system such as that described in No. 244,947. The analytical system is incorporated herein by reference in its entirety, as described in US Patent Application No. 13 / 244,947, filed September 26, 2011, CLIA. It can be configured in a compliant manner. In embodiments, a sample transported by the system or method provided herein is divided into two or more smaller pieces upon arrival at a site for processing or analysis, and various tests on the sample. Can be carried out. For example, in embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 tests are performed by the system or method provided herein. Can be performed on the transported sample. The test may include the use of different types of tests (eg, tests for proteins, nucleic acids, or cells) and one or more detection methods (eg, based on hemocytometer, luminescence, or spectrometer). In an embodiment, two or more sample containers containing a sample from a single subject can be transported, the two or more sample containers being at least two different anticoagulants mixed with the sample. (For example, one sample container contains EDTA-sample, and one sample container contains heparin-sample). The sample from the EDTA-sample container is then used for one or more tests that are heparin sensitive or EDTA insensitive. Similarly, the sample from the heparin-sample container is then used for one or more tests of EDTA sensitivity or heparin insensitivity. In embodiments, samples transported by the systems and methods provided herein can be divided into two or more smaller portions upon arrival at the destination, and 1, 2, 3, 4 Analyzed by 5, 6, 7, 8, 9, 10 or more different sample analyzers.

With reference to FIGS. 49-51, at least any two of the tests in the list (FIGS. 49-51) are performed using samples prepared or transported from the subject by the system or method provided herein. Please understand that it can be accomplished. For example, at least two tests on the list can be performed with fluid samples from the subject, and the total volume of the fluid samples used to perform the tests is less than 300 microliters. Yes, and the total volume of body fluid samples from said subjects is transported in liquid form within a sample container having an internal volume of 400 microliters or less. In another embodiment, at least two tests on the list can be performed with body fluid samples from the subject, and the total volume of the body fluid samples used to perform the tests is 300. Less than microliters, and the total volume of the body fluid sample from said subject is transported in liquid form within a first sample container and a second sample container, each container having an internal of 200 microliters or less. The first sample container having a volume contains a body fluid sample mixed with a first anticoagulant, and the second sample container contains a body fluid sample mixed with a second anticoagulant. including. In embodiments, the list of at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 50, or 60. (Figs. 49-51) are 5 mL, 4 mL, 3 mL, 2 mL, 1.5 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 150 μL, 100 μL, 75 μL, 50 μL, 40 μL, 30 μL, 20 μL, 10 μL, It can be performed using fluid samples from subjects with a total volume of less than 5 μL or 1 μL. The total volume of the body fluid sample can be stored and transported in a single sample container from the collection site to the analysis or processing site, or it can be 2, 3, 4, 5, 6, 7, 8, 9 It can be divided into 10, 11, 12, 13, 14, 15, 20, 25, or more sample containers. When the total volume of the fluid sample from a single subject is divided into two or more sample containers, some of the sample containers, or sample portions within each, may be different anticoagulants or other. May contain additives. In one example, a total volume of less than 300 microliters of body fluid sample from a subject can be used to perform two or more of the tests, at least one portion of the less than 300 microliter sample. Is mixed with the first anticoagulant, and the second portion of the less than 300 microliter sample is mixed with a second anticoagulant different from the first. Optionally, each portion of the less than 300 microliter sample can be in its own sample container. Optionally, two or more of the tests can be performed, all of the less than 300 microliter samples are transported in a single container and contain a single anticoagulant. Optionally, at least any three tests in the list may be performed for all tests using a total volume of less than 300 microliters of blood from the subject. Optionally, at least any five tests in the list may be performed for all tests using a total volume of less than 300 microliters of blood from the subject. Optionally, at least any seven tests in the list may be performed for all tests using a total volume of less than 300 microliters of blood from the subject. Optionally, at least any 10 tests in the list can be performed for all tests using a total volume of less than 300 microliters of blood from the subject. Optionally, at least any 15 tests in the list may be performed for all tests using a total volume of less than 300 microliters of blood from the subject. Optionally, at least any 20 tests in the list may be performed for all tests using a total volume of less than 300 microliters of blood from the subject. For any of the above, in at least some embodiments, at least one portion comprises a first anticoagulant, and a second portion is different from the first. Contains a second anticoagulant.

With reference to FIG. 52, yet another embodiment for body fluid sample collection is shown. FIG. 52 shows that the body fluid sample B on the subject is being collected by the collection device 3710. As seen in FIG. 52, the collection device 3710 may include a collection portion 3712, such as, but not limited to, a capillary tube or other collection structure. The collecting portion 3712 draws the fluid therein and finally directs it to the internal cavity 3714 of the device 3710. After the collecting portion 3712 has collected the desired amount, the entire device 3710 can be oriented as shown in FIG. 52 so that gravity can then pull the sample into the cavity 3714. The collection portion 3712 may be removed from the instrument 3710 after all of the sample B has been moved into the cavity 3714. In one embodiment, the cap and the collection portion 3712 are removed and replaced with a closed cap 3718. In one non-limiting example, the cap 3718 may have no openings on it. Optionally, some may have a bulkhead or other closed opening in the cap, and the collecting portion 3712 may be removed without the need to replace the cap with a new one of a different shape.

Modular sample collection device

With reference to FIGS. 53A-53C, embodiments herein are typically described as a sample collection device having an adapter portion 3750 to connect the sample collection portion 3740 to the sample storage container 3760. However, it should be understood that embodiments that do not have such a configuration are not excluded.

As a non-limiting example in FIG. 53A, one or more adapter portions 3750 are individual elements that are not initially in direct fluid communication with either the collection portion 3740 or the sample storage container 3760. In the present specification, the collection portion 3740 is provided in the container 3760 with the collection portion, the adapter portion 3750 in order to generate a fluid path from the collection channel into the container via the one or more adapter channels. , Or by means of relative movement between one or more of the containers 3760 (sequentially or simultaneously).

As a non-limiting example in FIG. 53B, as already suggested in some embodiments herein, some embodiments do not have a separate, separate adapter portion 3750. As shown herein, the collection portion 3740 may be directly connected to the container 3760 by means of relative movement between one or both of those elements, as indicated by the arrow 3770. As seen in FIG. 53B, there can be a fluid flow feature 3780 with relative relative movement between one or both of those elements as indicated by the arrow 3782. In one non-limiting example, the fluid flow feature 3780 can be a cap that engages one end of the collection portion 3740 to facilitate fluid flow into the container 3760. Optionally, the fluid flow feature 3780 can be a cap with a front surface shaped to engage the collection portion 3740. Optionally, the fluid flow feature 3780 can be an aspirator, a rod, and / or other device that facilitates flow towards the sample storage container 3760. Optionally, the fluid flow feature 3780 does not fully engage until the sample collection portion 3740 is ready to engage the container 3760. Optionally, some embodiments may be configured such that the flow from the collection portion 3740 to the sample storage container 3760 is performed without using the fluid flow feature 3780, but instead limited. It is based on different driving forces such as vacuum, vacuum suction, or blowing force that are not removed but are supplied from the appropriate end of the collection section 3740.

As a non-limiting example of FIG. 53C, one or more embodiments may use the collection portion 3740 as a storage container. In some embodiments, caps 3790 and 3792 can simply cover both ends once the desired filling level is achieved. As seen in FIG. 53C, the caps 3790 and 3792 can retain the fluid in it even when the portion 3740 is in vertical orientation.

There may be variations and alternatives to said embodiments described herein, and no single embodiment should be construed as including the entire invention. For example, there may be more than one capillary tube within the collecting portion 3740. Optionally, they can be formed as separate tubes or channels, respectively. Optionally, some may have a common first part, but have, but are not limited to, separate exit ports such as a Y-shape. It should be understood that any embodiment herein may be modified to include the features listed in the above description for FIGS. 53A-53C.

With reference to FIG. 54, after the sample container 3800 arrives at the desired processing destination, the sample in the container 3800 can be appropriately prepared. In one embodiment, the container 3800 is similar to that of container 3710. As can be seen in FIG. 54, the sample is processed to be partially divided and placed in processing equipment such as, but not limited to, an inlet of a cartridge 3802 and another inlet of another cartridge 3804. Can be done. In one embodiment, both cartridges 3802 sample, but are not limited to, Integrated Metabolic Panel (ALB, ALP, ALT, AST, BUN, Ca, Cl-, CRE, GLU, K +). , Na +, TBIL, tCO2, TP), Basic Metabolic Panel (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2) Lipid panel (CHOL, HDL, COOL / HDL, LDL, TRIG, VLDL, nHDLc); Lipid Panel Plus (tCHOL, HDL, COOL / HDL ratio, LDL, TRIG, VLDL, GLU, ALT, AST, nHDLc); Liver Panel Plus (ALB, ALP, ALT, AST, AMY, TBIL, TP, GGT); Electrolyte panel (Cl-, K +, Na +, tCO2); General chemistry (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, GGT, GLU) , TBIL, TP, UA); General Chemistry 6 (ALT, AST, CRE, eGFR, GLU, BUN, GGT); Renal Function Panel (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2PHOS); Metlyte (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU); Renal function (BUN, CRE, eGFR; Liver function panel (ALB, ALP, ALT, AST, DBIL) , TBIL, TP); basal metabolism (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2, Mg, LDH); MetLyte Plus CRP (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU, CRP); BioChemistryPanelPlus (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, CRP, GGT, GLU, TP, UA); Microfluid discs that are processed for blood chemical tests such as Ca, Cl-, CRE, GLU, K +, LAC, Mg, Na +, Phos, tCO2). Other fluid handling technologies developed in the future are also available. It should be understood that it may be adapted for use in at least one embodiment of the specification. Some fruits. In embodiments, the sample is a general chemical microfluidic / centrifuge cartridge 3802 (and / /) using a tubing that carries the fluid to a destination, such as, but not limited to, a fluid receiving port on the cartridge. Or it can be delivered to 3804). At least one other cartridge, such as, but not limited to, an open fluid motion type cartridge as described in the application, which is incorporated herein by reference, also improves the available inspection of that type. Can be used for It should be understood that although at least two destination cartridges are shown, embodiments with three or more destinations are not excluded (as indicated by the additional cartridges shown by the dotted lines). Fluid transport may be by pipette, fluid tubing, microfluidics, or other means of fluid handling techniques that may be developed in the future.

With reference to FIG. 55A, it should be understood that some embodiments may use a sample handling system with a pipette or the like to extract the sample from the container 3800 in a tubeless manner. Although pipettes are described in this embodiment, it should be understood that other fluid handling techniques developed in the future may also be adapted for use in at least one of the embodiments herein. FIG. 55A shows that an automated system can be used to evenly differentiate the sample. It should be understood that in some embodiments, sample dilution may be possible to increase the liquid volume of the sample before, during, or after equal division. This is useful for a variety of purposes. FIG. 55A also shows that in some embodiments, the sample can be delivered to a general chemical microfluidic / centrifuge cartridge 3802 (and / or 3804). At least one other cartridge, such as, but not limited to, an open fluid motion type cartridge as described in the application, which is incorporated herein by reference. It can be used to improve the types of tests available. It should be understood that although at least two destination cartridges are shown, embodiments with three or more destinations are not excluded (as indicated by the additional cartridges shown by the dotted lines). Fluid transport may be by pipette, fluid tubing, microfluidics, or other means of fluid handling techniques that may be developed in the future. In some embodiments, the same technique can be used to move the sample to the cartridge or other destination, or, optionally, to move the sample. One or more combinations of techniques may be used. In addition to using the cartridge 3802 as an example, but not a limitation, the examination increases, but is not limited to, ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemical and / or possible analysis of the type described above. Includes the use of other detection techniques, such as letting, other detection techniques. Optionally, it should be understood that two or more cartridges 3802 and / or separate unit cartridges 3806 can be used herein in the system for equal differentiation from said container 3800.

A further embodiment is shown with reference to FIG. 55B, in which the container 3800 is shown as having a sample fluid. In one embodiment, the sample fluid therein can be "neat" or undiluted. Optionally, in some embodiments, the sample is pretreated at the collection site and / or the receiving site to dilute the sample and / or provide certain chemicals into the sample. Can be configured to be able to. As seen in FIG. 55B, the fluid handling system may use a pipette 3602 to equalize the sample from container 3800 to one or more other containers 3810, 3812, and / or 3814. As a non-limiting example, these containers 3810, 3812, or 3814 can be the same container as that of container 3800. Optionally, they can be different types of containers. Based on the barcode or other information about the sample, the processor is programmed to determine at least the desired sample dilution for the sample, and at least the desired number of equal parts. In this non-limiting example, the equal parts are transported to one sample processing unit 3820, 3822, and 3824, respectively. These can all be the same type of processing unit, each can be of a different type from each other, or some can be the same and some can be different. In at least one non-limiting example, the sample processing unit can be a single sample processing machine or a batch processing machine capable of handling multiple samples at the same time.

FIG. 55C shows a further embodiment in which a sample is collected at a collection site and then transported to a second site, during which the sample remains in liquid form. FIG. 55C shows that multiple containers with samples can be collected from a single wound on said subject. This allows the subject to provide multiple samples that can be treated with different types of chemicals in each of the containers. FIG. 55C shows a courier who receives multiple samples from only one subject or multiple subjects and transports them to a site in a shipping container that may contain samples. Although humans are shown, it should be understood that robotic transport, drones, or other transport techniques, systems, or equipment developed in the future are not excluded (but not limited to the "virtual" of the sample above. Including transporting the version). In this non-limiting example, the receiving site may charge one or more containers 1504 from the shipping container into a cartridge having a reagent unit and / or a assay unit that can move independently. This cartridge can be packed in one or more processing modules 701-707. These units can be the same module. Optionally, at least one of the modules is different from the others. Similar to FIG. 55B, some embodiments dilute the sample from container 1504 prior to filling the cartridge with said container 1504 or other container containing said sample and / or pre-diluted sample. And / or including a processor 3830 (based on container ID or other accompanying information) capable of coordinating equidifferentiation. In at least one embodiment of the specification, each of the modules may receive at least one cartridge and at least one sample container. Optionally, two or more sample containers can be placed in each cartridge. Optionally, the sample container may contain different types of samples, so the cartridge may have two or more types of samples packed therein. Optionally, some embodiments may have a module having at least one receiving area for the cartridge and at least one receiving area for the sample.

Optionally, some embodiments may have only one place to receive the cartridge, which in turn may include at least one sample. In this way, the user reduces the risk of having to fill separate items in the module. Once filled, at least one embodiment of the specification is configured such that once the sample is inserted into the module, no user intervention is required. This non-limiting example can be used to minimize errors associated with human factors once the sample has been processed in the module.

It should be appreciated that some embodiments may handle multiple samples simultaneously using a centrifuge or other force that results in a descent to a settling level inside the sample vessel. In one non-limiting example, this can be achieved by means of tray centrifugation, such as, but not limited to, plate centrifugation with 384 holes.

FIG. 55C shows a system 700 according to an embodiment of the invention having a plurality of modules 701-706 and a hemocytometer 707. The plurality of modules include a first module 701, a second module 702, a third module 703, a fourth module 704, a fifth module 705 and a sixth module 706.

The hemocytometer station 707 is operably connected to each of the plurality of modules 701 to 706 by means of the sample handling system 708. The sample handling system 708 may include pipettes such as positive displacement, exhaust or suction type pipettes as described herein.

The hemocytometer station 707 includes a hemocytometer as described above and in other embodiments of the invention for performing hemocytometers on a sample. The hemocytometer station 707 performs a sample blood cell count, while one or more of the modules 701-706 perform other preparation and / or another sample assay procedures. In some cases, the hemocytometer station 707 performs a sample blood cell count after the sample has undergone sample preparation in one or more of the modules 701-706.

The system 700 includes a support structure 709 having a plurality of bays (or mounting stages). The plurality of bays are for docking the modules 701 to 706 to the support structure 709. The support structure 709 is a rack, as shown.

With the help of mounting members, each module is securely mounted in the rack 709. In one embodiment, the mounting member is hooked to either the module or the bay. In such cases, the hook is configured to slide into a receptacle in either the module or the bay. In another embodiment, the mounting member includes a fastener such as a screw fastener. In another embodiment, the mounting member is made of a magnetic material. In such cases, the module and bay may contain magnetic material of opposite polarity to provide an attractive force to securely attach the module to the bay. In another embodiment, the mounting member comprises one or more tracks or rails in the bay. In such cases, the module includes one or more structures that are coupled to the one or more tracks or rails, thereby ensuring that the module is mounted in the rack 709.

An example of a structure that allows a module to be coupled to a rack includes one or more pins. In some cases, the module receives the force directly from the rack. In some cases, the module can be a power source, such as a lithium ion, or a battery powered by a fuel cell, that internally powers the device. In one embodiment, the module is configured with the help of a rail to couple with the rack and for the power for the module to come directly from the rail. In another embodiment, the module couples to the rack with the support of mounting members (rails, pins, hooks, fasteners), but the power to the module is inductive (ie, inductively coupled), etc. As such, it is supplied wirelessly. In some embodiments, the coupling of the module with the rack does not require pins. For example, individual electrical communications may be provided between the module and the rack or other support. In some cases, wireless communication may be used with the support of ZigBee communication or other communication protocols or protocols developed in the future.

Each module may be removable from the rack 709. In some cases, one module can be replaced with similar or different modules and the like. In one embodiment, the module can be removed by sliding the module out of the rack 709. In another embodiment, the module can be removed from the rack 709 by twisting or rotating the module so that the mounting members of the module disengage with the rack 709. Removing the module from the rack 709 can terminate any electrical connectivity between the module and the rack 709.

In one embodiment, the module is mounted on the rack by sliding the module into the bay. In another embodiment, the module is attached to the rack 709 by twisting or rotating the module so that the mounting members of the module engage the rack 709. Attaching the module to the rack 709 can establish an electrical connection between the module and the rack. The electrical connection provides a communication bus from the module to power the module or rack or equipment and / or between the module and one or more other modules or controls of the system 700. It can be to provide.

Each bay of the rack may or may not be occupied. As shown, all bays of the rack 709 are occupied by modules. In some cases, however, one or more of the bays of the rack 709 are not occupied by the module. In one embodiment, the first module 701 is removed from the rack. The system 700 may operate without the removed module in such cases.

In some cases, the bay may be configured to accommodate a subset of the types of modules configured for use by said system 700. For example, a bay agglutination test may be configured to accept a module that does not have the ability to perform a hemocytometer test. In such cases, the module can be "specialized" for agglomeration. Aggregation can be measured by a variety of methods. Measuring the time-dependent change in turbidity of the sample is one method. This can be achieved by irradiating the sample with light and measuring the reflected light at 90 degrees with an optical sensor such as a photodiode or camera. Over time, the measured light increases as more light is scattered by the sample. Measuring time-dependent changes in transmittance is another example. In the latter case, this is achieved by irradiating the sample in a container and measuring the light passing through the sample with an optical sensor such as a photodiode or a camera. Over time, as the sample aggregates, the measured light diminishes or increases (eg, the aggregated material remains in the suspension or settles out of the suspension. In other cases, the bay is for the system 700 to accept all types of modules from the detection station configured for use to the supporting electrical system. It is composed of.

Each of the modules may be configured to function (or perform) independently of the other modules. In one embodiment, the first module 701 is configured to perform independently of the second 702, third 703, fourth 704, fifth 705 and sixth 706 modules. obtain. In other cases, the module is configured to perform with one or more other modules. In such cases, the module may allow parallel processing of one or more samples. In one embodiment, the second module 702 tests the same or different samples while the first module 701 prepares the sample. Allows for minimization or elimination of downtime between the modules.

The support structure (or rack) 709 may have a wagon type configuration. In some cases, the various dimensions of the rack are standardized. In one embodiment, the spacing between the modules 701-706 is at least about 0.5 inch, or 1 inch, or 2 inch, or 3 inch, or 4 inch, or 5 inch, or 6 inch, or 7 inch. , Or 8 inches, or 9 inches, or 10 inches, or 11 inches, or multiples of 12 inches.

The rack 709 may indicate the weight of one or more of the modules 701-706. Additionally, the rack 709 is selected such that the module 701 (top) is attached to the rack 709 without generating a moment arm that can cause the rack 709 to rotate or tip over. Has the center of the vacuum. In some cases, the center of the rack 709 vacuum is located between the vertical midpoint of the rack and the base of the rack, which is 50% from the base of the rack 709 and the top of the rack. It is in. In one embodiment, the center of the rack 709 vacuum, measured along a vertical axis away from the base of the rack 709, is at least about 0.1 of the height of the rack measured from the base of the rack 709. %, Or 1%, or 10%, or 20%, or 30%, or 40%, or 50%, or 60%, or 70%, or 80%, or 90%, or 100%. ..

The rack may have multiple bays (or mounting stations) configured to accommodate one or more modules. In one embodiment, the rack 709 may have six mounting stations, each of which modules 701 to 706 are allowed to be mounted in the rack. In some cases, the bay is on the same side of the rack. In other cases, the bays alternate on either side of the rack.

In some embodiments, the system 700 includes electrical connectivity components for electrically connecting the modules 701 to 706 to each other. The electrical connectivity component can be a bus, such as a system bus. In some cases, the electrical connectivity component also allows the modules 701-706 to communicate with each other and / or with the control device of the system 700.

In some embodiments, the system 700 includes a control device (not shown) for facilitating sample processing with the assistance of one or more of the modules 701-706. In one embodiment, the control device facilitates parallel processing of the samples in the modules 701-706. In one embodiment, the controller provides the sample handling system 708 with the samples in the first module 701 and commands the second module 702 to simultaneously perform the sample different tests. In another embodiment, the controller provides the sample handling system 708 with a sample in the modules 701-706 and the sample (such as a finite volume portion of the sample) with the blood cell. Hemocytometer and one or more other sample preparation procedures and / or tests are performed in parallel for the sothat sample, as it also commands the calculation station 707 to provide. In such a manner, the system minimizes downtime between the modules 701-706 and the hemocytometer 707 if not eliminated.

Each individual module of the plurality of modules may include a sample handling system for providing samples to various processing and testing modules of the individual modules and removing the samples from them. In addition, each module may include various sample processing and / or testing modules in addition to other components that facilitate sample processing and / or testing with the help of said module. The sample handling system for each module may be separate from the sample handling system 708 for system 700. That is, the sample handling system 708 moves the sample to or from the modules 701 to 706, whereas the sample handling system of each module varies within each module. Sample processing and / or moving samples to or from the test modules.

In the illustrated embodiment of FIG. 55C, the sixth module 706 includes a sample handling system 710, including a suction type pipette 711 and a positive displacement pipette 712. The sixth module 706 includes a centrifuge 713, a spectrometer 714, a nucleic acid assay (such as a polymerase chain reaction (PCR) assay) station 715 and a PMT716. An example of the spectrometer 714 is shown in FIG. 55C (see below). The sixth module 706 further includes a cartridge 717 for holding a plurality of chips to facilitate the transfer of samples to or from the processing or testing module of the sixth module.

In one embodiment, the suction type pipette 711 is one or more, or two or more, or three or more, or four or more, or five or more, or six or more, or seven or more, or eight or more. Or 9 or more, or 10 or more, or 15 or more, or 20 or more, or 30 or more, or 40 or more, or 50 or more heads. In one embodiment, the suction type pipette 711 is an eight-headed pipette having eight heads. The suction type pipette 711 may be described in another embodiment of the present invention.

In some embodiments, the positive displacement pipette 712 is approximately 20%, 15%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%. It has a coefficient of variation of 1, 1%, 0.5%, 0.3%, or 0.1% or less or less. The coefficient of variation is determined according to σ / μ, where “σ” is the standard deviation and “μ” is the average over the sample measurements.

In one embodiment, all modules are identical to each other. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, fourth, fifth, and sixth modules 701-706 are positive displacement pipettes and suction type pipettes and nucleic acid assay and spectrometers. Including various tests such as. In another embodiment, at least one of the modules 701-706 may have a test and / or sample preparation station that differs from the other modules. In one example, the first module 701 includes an aggregation test but does not include a nucleic acid amplification test, and the second module 702 includes a nucleic acid test but does not include an aggregation test. The module does not have to contain any test.

In the illustrated example of FIG. 55C, the modules 701-706 include the same test and sample preparation (or manipulation) station. However, in other embodiments, each module comprises any number and combination of test and processing stations described herein.

The modules can be stacked vertically or horizontally with respect to each other. The two modules are oriented perpendicular to each other if they are oriented along a plane that is parallel, substantially parallel, or nearly parallel to the gravitational acceleration vector. The two modules are oriented horizontally with respect to the gravitational acceleration vector if they are orthogonal, substantially orthogonal, nearly orthogonal, or oriented along a plane.

In one embodiment, the modules are stacked vertically, i.e. one module is stacked on top of another module. In the illustrated example of FIG. 55C, the rack 709 is oriented such that the modules 701-706 are arranged vertically in relation to each other. However, in other cases the modules are oriented so that they are arranged horizontally in relation to each other. In such cases, the rack 709 may be oriented so that the modules 701-706 can be horizontally on the same side of each other.

Yet another embodiment of the system 730 with a plurality of modules 701-704 is shown. In this embodiment, the modules 701 to 704 are X, Y, and / or optionally for moving elements such as sample containers, chips, cuvettes, etc. within and / or between modules. It shows a horizontal configuration attached to a support structure 732 that allows the transport equipment 734 to move along the Z axis. As a non-limiting example, the modules 701-704 are horizontal to each other if they are orthogonal, substantially orthogonal, nearly orthogonal, or oriented along a plane with respect to the gravitational acceleration vector. Oriented to.

It should be understood that all of the modules 701-704 can be identical to each other, as in the embodiment of FIG. 55C. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, and / or fourth modules 701-704 can occupy the location of the module to be replaced by one or more other modules. Can be replaced. The other modules are optionally, but not limited to, one of the modules 701 to 704, one or more blood cell calculation modules 707, communication modules, storage modules, sample preparation modules, slide preparation modules, tissue preparation modules. Provides different functionality, such as replacing with. For example, one of the modules 701-704 is different, such as providing, but not limited to, a thermally controlled storage chamber for incubation, storage during and / or post-test storage. It can be replaced by one or more modules that provide the hardware configuration. Optionally, which replaces one or more of the modules 701-704, the module is an additional telecommunications device, additional imaging or user interface device for the system 730, but not limited to. , Or, but not limited to, can provide functionality unrelated to certification such as additional power sources such as batteries, fuel cells, etc. Optionally, replacing one or more of the modules 701-704, the module may provide additional disposable material and / or storage of reagents or fluids. It should be understood that while some embodiments show only four modules mounted on the support structure, other embodiments with fewer or more modules are not excluded from the horizontal mounting configuration. It should be appreciated that, in particular, in scenarios where one or more types of modules take up more power than the other modules, the configuration can be done without all the bays or slots occupied by the modules. In such a configuration, the power directed to the empty bay could otherwise be used by the module, which takes more power than others.

It should be understood that all of the modules 701-706 can be the same module as in the embodiment of FIG. 55C. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, and / or fourth modules 701-706 can occupy the location of the module to be replaced by one or more other modules. Can be replaced. The other modules are optionally, but not limited to, one of the modules 701 to 704, one or more blood cell calculation modules 707, communication modules, storage modules, sample preparation modules, slide preparation modules, tissue preparation modules. Provides different functionality, such as replacing with.

Some embodiments indicate that only six modules are mounted on the support structure, but other embodiments with fewer or more modules are not excluded from the horizontal and vertical mounting configurations. I want to be understood. It should be appreciated that, in particular, in scenarios where one or more types of modules take up more power than the other modules, the configuration can be done without all the bays or slots occupied by the modules. In such a configuration, the power directed to the empty bay could otherwise be used by the module, which takes more power than others.

Some embodiments may provide a system with multiple modules 701, 702, 703, 704, 706, and 707. Such embodiments provide, but are not limited to, a thermally controlled storage chamber for incubation, storage between tests, and / or storage after tests, etc. Can have additional modules with different hardware configurations. Optionally, which replaces one or more of the modules 701-704, the module is an additional telecommunications device, additional imaging or user interface device for the system 730, but not limited to. , Or, but not limited to, can provide functionality unrelated to certification such as additional power sources such as batteries, fuel cells, etc. Optionally, replacing one or more of the modules 701-704, the module may provide additional disposable material and / or storage of reagents or fluids.

FIG. 55C shows that only seven modules are mounted on the support structure, but it should be understood that other embodiments with fewer or more modules are not excluded from this mounting configuration. It should be appreciated that, in particular, in scenarios where one or more types of modules take up more power than the other modules, the configuration can be done without all the bays or slots occupied by the modules. In such a configuration, the power directed to the empty bay could otherwise be used by the module, which takes more power than others.

In some embodiments, the modules 701 to 706 may include electronic circuits and components for facilitating communication with each other and / or between the controller of the system 700 and the module and / or the controller. It is in a communication state by means of a communication bus (“bus”). The communication bus includes a subsystem that transfers data between the module and / or the control device of the system 700. The bus provides various components of the system 700 with communication with the central processing unit (CPU), memory (eg, internal memory, system cache) and storage location (eg, hard disk) of the system 700.

The communication bus may include multiple connections, or parallel electrical wiring with parallel electrical wiring with any physical arrangement that provides logical functionality, as a parallel electrical bus. The communication bus can include both parallel and bit series connections, and is wired in either a branch (ie, electrical parallel) or daisy chain topology, or connected by a switched bus. .. In one embodiment, the communication bus can be a first generation bus, a second generation bus or a third generation bus. The communication bus allows communication with each of the communication modules and with other modules and / or the control device. In some cases, the communication bus allows communication between a plurality of systems similar to, or the same as, the system 700.

The system 700 may include one or more series buses, parallel buses, or self-healing buses. The bus may include a master scheduler that controls data traffic, such as traffic to or from modules (eg, modules 701-706), controllers, and / or other systems. The bus may include an external bus that connects external equipment and systems to a main system board (eg, a mother board), and an internal bus that connects internal components of the system to said system board. The internal bus connects internal components to one or more central processing units (CPUs) and internal memory.

In some embodiments, the communication bus can be a wireless bus. The communication bus is Firewire (IEEE1394), USB (1.0, 2.0, 3.0, or something else), Thunderbolt, or another protocol (currently or in the future).

In some embodiments, the system 700 is a media bus, a computer-automated measurement and control (CAMAC) bus, an industry standard architecture (ISA) bus, a USB bus, a firewire, a thunderbolt, an extended ISA (EISA). Bus, Low Pin Count Bus, M Bus, Micro Channel Bus, Multi Bus, Nubus or IEEE1196, OPTi Local Bus, Peripheral Component Interconnect (PCI) Bus, Parallel Advanced Technology Attachment (ATA) Bus, Q-Bus, S-100 Bus (Or IEEE696), S Bus (or IEEE1496), SS-50 Bus, STE Bus, STD Bus (for STD-80 [8-bit] and STD32 [16- / 32-bit]), Unibus, VESA Local Bus , VME bus, PC / 104 bus, PC / 104Plus bus, PC / 104Express bus, PCI-104 bus, PCIe-104 bus, 1-wire bus, Hyper Transport ^{bus, Inter-Integrated Circuit (I 2} C) bus, PCI Express (or PCIe) bus, series ATA (SATA) bus, series peripheral interface bus, UNI / O bus, SM bus, 2-wire or 3-wire interface, self-healing elastic interface bus and variants and / Or includes one or more buses selected from the group consisting of combinations thereof.

In some cases, the system 700 is a serial peripheral interface that connects one or more microprocessors of the system 700 and peripheral components or I / O components (eg, modules 701 to 706). (SPI) is included. The SPI is two or more, or three or more, or four or more, or five or more, or six or more, or seven or more, or eight or more, or nine or more. , Or 10 or more or 50 or more or 100 or more I / O component compatible SPIs can be used to attach to a microprocessor or multiple microprocessors. In another example, the system 700 includes RS-485 or other standard.

In one embodiment, SPIs with SPI bridges having parallel and / or serial topologies are provided. Such a bridge allows the selection of one of the many SPI components on the SPII / O bus without the proliferation of chip selection. This is achieved by daisy-chaining the equipment, or applying appropriate control signals to allow chip selection for the equipment on the SPI bus, as described below. However, it maintains a parallel data path so that there is no daisy chaining of data to be moved between SPI components and microprocessors.

In some embodiments, SPI bridge components are provided between a microprocessor and multiple SPII / O components that are connected by a parallel and / or serial (or serial) topology. The SPI bridge component enables parallel SPI using (CSL /) series (daisy chain) local chip-selective connections to MISO and MOSI lines and other slaves. In one embodiment, the SPI bridge components provided herein also solve any problems associated with multiple chip selection for multiple slaves. In another embodiment, the SPI bridge components provided herein are 4, 8, 16, 32, 64 or more individual chip selections for four SPI enabled devices (CS1 / -CS4 /). To support. In another embodiment, the SPI bridge components provided herein allow four cascading of external address line settings (ADR0-ADR1). In some cases, the SPI bridge components provided herein provide the ability to control up to 8, 16, 32, 64, or more general purpose output bits for control or data. The SPI bridge components provided herein allow control of general purpose input bits up to 8, 16, 32, 64, or more, in some cases for control or data, and said master. Can be used for device identification and / or diagnostic communication to said master.

One embodiment may use an SPI bridge arrangement with a master and parallel serial SPI slave bridges according to embodiments of the present invention. Multiple slave device cascading, virtual daisy chaining of device chip selection to keep the module-to-module signal count at acceptable levels, support for module identification and diagnosis, and slaves controlled by embedded SPI. The SPI bus is used to allow the addition of various system characteristics, including essential and non-essential system characteristics, such as communication to non-SPI components on the module, while maintaining compatibility with the components. , Local chip selection to SPI bridge (CSL /), module selection (MOD_SEL), and selection data (DIN_SEL) can be increased by adding to the SPI bridge. FIG. 41B shows an example of an SPI bridge according to an embodiment of the present invention. The SPI bridge includes internal SPI control logic, control registers (8 bits as shown), and various input and output pins.

Each slave bridge is connected to a master (also referred to herein as the "SPI master" and "master bridge") in a parallel series configuration. The MOSI pins of each of the slave bridges are connected to the MOSI pins of the master bridge, and the MOSI pins of the slave bridge are connected to each other. Similarly, the MISO pins of each slave bridge are connected to the MISO pins of the master bridge, and the slave bridge MISO pins are connected to each other.

Each slave bridge can be a module (eg, one of the modules 701-706 in FIG. 7), or a component within the module. In one embodiment, the first slave bridge is the first module 701, the second slave bridge is the second module 702, and the like. In another embodiment, the first slave bridge is a component of the module.

At least one non-limiting example may use a diagram of module components with interconnected module pins and master and slave bridges according to embodiments of the present invention. The slave bridge can be connected to the master bridge according to the embodiment of the present invention. The MISO pins of each of the slave bridges are electrically connected to the MOSI pins of the master bridge. The MISO pin of each of the slave bridges may be in electrical communication with the MOSI pin of the master bridge. The DOUT_SEL pin (left) of the first slave bridge is in electrical communication with the DOUT_SEL pin of the second slave. The DOUT_SEL pin of the first slave bridge is in electrical communication with the DIN_SEL (right) of the second slave. By electrically connecting each additional slave bridge DIN_SEL pin to the DOUT_SEL pin of the previous slave bridge, the additional slave bridge can be connected as said second slave. In such a manner, the slave bridges are connected in a parallel series configuration.

In some embodiments, the clock pulse directed at the connected SPI-bridge captures the state of the DIN_SEL bits shifted into the bridge in the assertion of the module selection line (MOD_SEL). The number of DIN_SEL bits corresponds to the number of modules connected together on the parallel series SPI link. In one embodiment, if the two modules are connected in a parallel series configuration (eg RS486), the number of DIN_SEL is equal to 2.

In one embodiment, the SPI-bridge that latches "1" during the module selection sequence is a "selected module" set that receives 8-bit control words during the subsequent element selection sequence. Each SPI-bridge can access up to four chained SPI slave devices. In addition, each SPI-bridge may have an 8-bit GP receive port and an 8-bit GP transmit port. The "element selection" sequence is the "selected module" SPI-bridge control to allow subsequent transactions with a particular SPI device, or to read or write data through the SPI-bridge GPIO port. Write an 8-bit word to the register.

In one embodiment, element selection can occur by clocking the assertion of the local chip selection line (CSL /), followed by the first byte of the data word transferred to the control register by the first MOSI. In some cases, the format of the control register is CS4CS3CS2CS1AD1AD0RWN. In another embodiment, the second byte is for transmitting or receiving data. When CSL / is stopped asserting, the cycle is complete.

In the SPI transaction, the element selection sequence is followed by a subsequent SPI slave data transaction. The SPICS / (which may be referred to as SS /) is directed to one of four possible bridged devices for the true state of any of the CS4, CS3, CS2 or CS1. Jumper bits AD0, AD1 allow up to four SPI-bridges on the module compared to AD0, AD1 in the control register.

One embodiment refers to a device having a plurality of modules mounted on the SPI link of the communication bus of the device according to one embodiment described in the present invention. Three modules, namely module 1, module 2 and module 3, are illustrated. Each module is one or more for electrically connecting the various components of the module to the SPI link, including a master controller (including one of one or more CPUs) in telecommunications with the SPI link. Includes the SPI bridge. Module 1 includes a plurality of SPI slaves in telecommunications with each of SPI bridge 00, SPI bridge 01, SPI bridge 10 and SPI bridge 11. In addition, each module includes a receive data controller, a transmit data controller and a module ID jumper.

In other embodiments, the modules 701-706 are configured to communicate with each other and / or with one or more control devices of the system 700 with the assistance of a wireless communication bus (or interface). In one embodiment, the modules 701-706 communicate with each other with the assistance of a wireless communication interface. In another embodiment, one or more of the modules 701-706 communicate with the control device 700 of the system with the assistance of a wireless communication bus. In some cases, communication between modules 701-706 and / or one or more control devices of the system is performed only by means of a wireless communication bus. This can advantageously rule out the need for a radio interface during the delimiter to accept the modules 701-706. In other cases, the system 700 includes a wired interface that operates in conjunction with the wireless interface of the system 700.

The system 700 has a single rack as shown, but a system such as the system 700 may have multiple racks. In some embodiments, the system is up to 1, or 2, or 3, or 4, or 5, or 6, or 7, or 8, or 9, or 10, or 20, or 30, or 40. , Or 50, or 100, or 1000, or 10,000 racks. In one embodiment, the system has a plurality of racks arranged in adjacent configurations.

In some embodiments, a sample is provided for a system having one or more modules, such as the system 700 of FIG. 55C. The user provides the sample to a sample collection module of the system. In one embodiment, the sample collection module is a lancet, needle, microneedle, venous blood draw, surgical scalpel, cup, wipe, wash, bucket, basket, kit, permeable matrix, or other of the present specification. Includes one or more of any other sampling mechanisms or methods described in the section. The system then directs the sample from the sample collection module to one or more processing modules (eg, modules 701-706) for sample preparation, validation and / or detection. In one embodiment, the sample is directed from the collection module to the one or more processing modules with the assistance of a sample handling system such as a pipette. The sample is then processed within the one or more modules. In some cases, the sample is tested in the one or more modules and then passes through one or more detection routes.

In some embodiments, following the processing in the one or more modules, the system communicates the result to a user or system (eg, a server) that communicates with the system. Other systems or users can then access the results to assist in the treatment or diagnosis of the subject.

In one embodiment, the system is for bidirectional communication with another system, such as a similar or similar system (eg, racks described in the context of FIG. 55C), or other computer systems, including servers. It is composed.

The equipment and methods provided herein can advantageously reduce the energy or carbon dioxide emissions of a point of service system by allowing parallel processing. In some situations, systems such as System 700 in Figure 55C may be up to 10%, 15%, 20%, 25%, 30%, 35 of other point of service systems. It has%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% carbon dioxide emissions.

In some embodiments, methods are provided for detecting the specimen. In one embodiment, the processing routine comprises detecting the presence or absence of a sample. Processing routines are facilitated with the assistance of the systems and equipment provided herein. In some cases, the specimen may be a biological process, a physiological process, an environmental condition, a sample condition, one or more autoimmune diseases, obesity, hypertension, diabetes, degenerative diseases of nerves and / or muscles, heart disease, endocrine. It is associated with a disease, such as a disease, or the stage of the disease.

In some cases, one device processes one sample at a time. However, the system provided herein is configured for processing multiplexed samples. In one embodiment, one device processes multiple samples at one time or in duplicates. In one example, the user provides a sample to a device with multiple modules, such as the system 700 of FIG. 55C. The device then processes the sample with the assistance of one or more modules of the device. In another example, the user provides multiple samples to a device with multiple modules. The instrument then processes the samples simultaneously by processing the first sample of the first module while processing the second sample of the second module with the assistance of the plurality of modules.

The system may process the same or different types of samples. In one embodiment, the system processes one or more pieces of the same sample at the same time. This is useful when various assay and / or detection protocols for the same sample are required. In another embodiment, the system processes different types of samples simultaneously. In one example, the system processes blood and urine samples simultaneously, either in different modules of the system or in a single module with a processing station for processing blood and urine samples.

In some embodiments, the method of processing a sample with the assistance of a point-of-service system, such as System 700 in FIG. 55C, is to accept the criteria or parameters of the inspection, and the sequence of inspections based on the criteria. Or it involves determining a schedule. The inspection criteria are accepted from the user, the system communicating with the point of service system, or the server. The inspection criteria can be selected based on desirable or predetermined effects such as time, cost, use of components, steps and energy minimization. The point of service system processes samples in the order or schedule of inspections. In some cases, a feedback loop (combined with a sensor) allows the point of service system to monitor the progress of sample processing and the maintenance or change of inspection instructions or schedules. In one example, if the system detects that the process will take longer than the predetermined time described in the schedule, it will either speed up the system or perform parallel processing, such as sample processing in another module of the system. adjust. The feedback loop allows real-time or pseudo-real-time (eg, cached) monitoring. In some cases, the feedback loop involves another test and / or test, or subsequent test, test, preparation step and / or other process that should be started after the detection of one or more parameters is started or finished. It may provide permission for possible reflex tests. Such subsequent testing, testing, preparation steps, and / or other processes can be initiated automatically without human intervention. Optionally, the reflex test is performed in response to the test results. That is, as a non-limiting example, when a reflex test is ordered, the cartridge is prefilled with reagents for Test A and Test B. Test A is a preliminary test and Test B is the reflex test. Once the results of Test A meet certain criteria for initiating the reflex test, Test B is then performed on the same sample in the instrument. The instrument protocol is designed to constitute the possibility of performing the reflex test. Some or all protocol steps of Test B may be performed before the results of Test A are complete. For example, sample preparation can be completed in advance on the instrument. It is also possible to perform a reflex test with a second sample from the patient. In some embodiments, the instruments and systems provided herein may include components for reflection testing of a plurality of different tests and test types on the same instrument. In some embodiments, clinically significant multiplex tests can be performed as part of a reflex test protocol in the single instrument provided herein, with known systems and methods. Performing the same test requires two or more separate instruments. Thus, the systems and equipment provided herein allow, for example, reflex tests that require faster and smaller samples than known systems and methods. In addition, in some embodiments, it is not necessary to know in advance which reflex test will be performed for the device reflex test provided herein.

In some embodiments, the point of service system may adhere to a given inspection instruction, or schedule, based on initial parameters and / or desired effects. In other embodiments, the schedule and / or inspection instructions may be modified on the fly. The schedule and / or inspection instructions are one or more detected states, one or more additional processes to be driven, one or more processes to be stopped, one or more processes to be modified, one. Modification of the use of these resources / components, one or more detected error or alarm conditions, availability of one or more resources and / or components, subsequent input provided by one or more users. Or it can be modified based on samples, external data, or any other reason.

In some embodiments, one or more initial samples may be provided to the device and then one or more additional samples may be provided to the device. The additional sample can be from the same subject or different subjects. The additional sample can be the same type of sample as the original sample, or a different type of sample (eg, blood, tissue). The additional samples may be provided simultaneously and / or subsequently prior to processing one or more initial samples on the instrument. The same and / or different tests, or desired criteria, may be provided for additional samples to contrast with each other and / or the first sample. The additional sample may be processed sequentially and / or in parallel with the first sample. The additional sample may use the same or different components as one or more initial samples. The additional sample may or may not be required depending on the detection status of one or more of the first samples.

In some embodiments, the system accepts samples with the assistance of a sample collection module such as a lancet, scalpel, or liquid collection container. The system then loads or accesses the protocol to perform one or more processing routines from a plurality of possible processing routines. In one example, the system loads a centrifugation protocol and a hemocytometer protocol. In some embodiments, the protocol may be loaded from an external device of the sample processing device. As an alternative, the protocol may already be in the same sample processing equipment. The protocol may be based on one or more requirements and / or processing routines. In one embodiment, protocol creation may include creating a list of one or more subtasks for each input process. In some embodiments, individual subtasks are performed by a single component of one or more devices. Creating a protocol can also include creating a list order and timing and / or allocation of one or more resources.

In one embodiment, the protocol provides a sample or processing details or specifications specific to the components within the sample. For example, the centrifugation protocol can include a rotation speed suitable for a given sample density, and a processing time, depending on the density of the sample from other substances that may be present with the desired component of the sample. Allows separation.

Protocols are retrieved from other systems, such as databases, that are included in or are in communication with the system, such as protocol repositories within the system. In one embodiment, for one or more processing protocols of the system, there is a one-way communication state with a database server that provides the protocol to the system in response to a request from the system. In another embodiment, it allows the system to upload user-specific processing routines to a database server for future use by the user, or other users who may use the user-specific processing routines. , It is in a two-way communication state with the database server.

With reference to FIGS. 56A and 56B, the transport container 4000 is configured to contain a plurality of body fluid samples from a plurality of subjects such as a patient. In some embodiments, there are containers for multiple samples from each subject. Optionally, at least two samples from the same subject undergo different chemical pretreatments, such as, but not limited to, different anticoagulants in their respective containers. Optionally, some embodiments may use a container having two or more separate chambers, each chamber holding a portion of said fluid sample that is separate from the fluid sample in another chamber. Is configured to. Some embodiments may include a sample from a subject in a single chamber container and / or multiple chamber containers.

Various views of one embodiment of the transport container 4000 are shown, as seen in FIGS. 56A and 56B, with the lid 4010 in a recess above the bottom of the transport container 4000, as seen in FIG. 57A. The container 4000 is stackable because it has at least one mesa portion 4012 sized for fitting. The transport container 4000 may have any of the features described herein for other embodiments of the transport container described herein.

FIG. 57B shows that in the shipping container 4000, there may be a removable tray 4030 fixed to and / or from the shipping container 4000. In one embodiment, the tray 4030 is provided by a fixed device, such as a magnetic or metal portion 4032, that aligns with, but is not limited to, the metal or magnetic portion of the housing of the transport container 4000 to form a magnetic connection. , Held in the right place. In some embodiments, the length-to-width aspect ratio is in the range of about 128:86 to 127:85. Optionally, the length-to-width aspect ratio is in the range of about 130: 90 to 120: 80. Optionally, the length of the tray is in the range of about 130 mm to 120 mm, and the width is in the range of about 90 mm to 80 mm. In some embodiments, the height or thickness of the tray is in the range of about 14-20 mm. The aspect ratio and / or size is configured to hold a tray sized to fit into a slot, concave surface, or other holder on the plate centrifuge. Thus, the entire tray 4030 can be centrifuged in it to prepare multiple samples.

As seen in FIGS. 57B and 58B, the tray 4030 has a plurality of slots 4034, which are sized to hold at least one of the sample storage containers. At least one portion 4040 of the slot 4034 has a first shape, and at least the second portion 4042 has a second shape different from the first shape. It can be locked by being inserted into the slot 4034 only in the desired orientation. As can be seen in FIG. 58B, one end is semi-circular while the other end is asymmetrically shaped. Since the tray 4030 is also shaped to have a cutout 4036 or other shape, the tray 4030 can be inserted into the transport container 4000 in only one orientation. It should also be appreciated that the user cannot remove the container 4000 with a finger without a tool or other tray extraction device, as the tray 4030 can be held in the tray. This minimizes the risk of user interference. The tray 4030 is held in the transport container 4000 even if the transport container 4000 is upside down and can withstand the pull of Earth's gravity.

59A and 59B show yet another embodiment in which the plurality of slots 4100 are in the tray 4102. The tray has different aspect ratios (close to a square) and has multiple shaped slots in the tray to hold the sample container.

In at least one embodiment described herein, the treatment optionally begins with the first separation process of the component formed from the liquid component, but not limited to, from the formed component such as red blood cells. No plasma is extruded or minimally extruded through the separation gel between the formed layer and the layer of the liquid component, at a time after the separation step, such as a second or subsequent separation. Sample collection locations, such as, but not limited to, analysis sites, patient service centers (PSCs), or remote locations separate from retail sites such as pharmacies to allow only plasma to be extruded. Includes, or substantially complete, plasma separation of the sample in.

In one embodiment, the time interval between the first separation step and the subsequent separation step is at least about 1 hour. Optionally, the time interval is at least about 2 hours. Optionally, the time interval is at least about 3 hours. Optionally, the time interval is at least about 4 hours. Optionally, the time interval is at least about 5 hours. Optionally, the time interval is at least about 6 hours. Optionally, the time interval is at least about 7 hours. Optionally, the time interval is at least about 8 hours. Optionally, the time interval is at least about 9 hours. Optionally, the time interval is at least about 10 hours. Optionally, the time interval is at least about 11 hours. Optionally, the time interval is at least about 12 hours. Optionally, the time interval is at least about 13 hours. Optionally, the time interval is at least about 14 hours. Optionally, the time interval is at least about 15 hours. Optionally, the time interval is at least about 16 hours. Optionally, the time interval is at least about 17 hours. Optionally, the time interval is at least about 18 hours. Optionally, the time interval is at least about 19 hours. Optionally, the time interval is at least about 20 hours. Optionally, the time interval is at least about 21 hours. Optionally, the time interval is at least about 22 hours. Optionally, the time interval is at least about 23 hours. Optionally, the time interval is at least about 24 hours. Optionally, the time interval is at least about 28 hours. Optionally, the time interval is at least about 32 hours. Optionally, the time interval is at least about 362 hours. Optionally, the time interval is at least about 40 hours. Optionally, the time interval is at least about 44 hours. Optionally, the time interval is at least about 48 hours.

In one embodiment, the time interval is not limited to, at least, excess serum or plasma that comes into contact with red blood cells after the first separation, and such subsequent separation steps, such as excess serum or plasma. It is sufficient time to allow expression from under a separation barrier such as a gel barrier between most of the formed and liquid components in the sample.

In one embodiment, the first separation step comprises centrifuging at least about 3000 g. In one embodiment, the first separation step comprises centrifuging at least about 3100 g. In one embodiment, the first separation step comprises centrifuging at least about 3200 g. In one embodiment, the first separation step comprises centrifuging at least about 3300 g. In one embodiment, the first separation step comprises centrifuging at least about 3400 g. In one embodiment, the first separation step comprises centrifuging at least about 3500 g. In one embodiment, the first separation step comprises centrifuging at least about 3550 g. In one embodiment, the first separation step comprises centrifuging at least about 3575 g. Optionally, the method includes an initial accelerated settling force, such as, but not limited to, a centrifugation step of at least about 3700 g. The method includes, but is not limited to, the first accelerated sedimentation force, such as a centrifugation step of at least about 3800 g. The method includes, but is not limited to, the first accelerated sedimentation force, such as at least about 3900 g of centrifugation step. The method includes, but is not limited to, the first accelerated sedimentation force, such as at least about 3950 g of centrifugation step. In some embodiments, the gravitational acceleration generated in the first centrifugation step herein is less than 3100 g, 3200 g, 3300 g, 3400 g, 3500 g, 3600 g, 3700 g, 3800 g, 3900 g, or 3990 g. it can. In some embodiments, the minimum values of about 3000g, 3100g, 3200g, 3300g, 3400g, 3500g, 3600g, 3700g, 3800g, 3900g, or 3950g, and 3100g, 3200g, 3300g, 3400g, 3500g, 3600g, 3700g, 3800g. It may have an acceleration selected from a range having a maximum value of 3,900 g, or 3990 g. In at least one embodiment, the minimum acceleration can be at least 1400g for any of the above. In at least one embodiment, the minimum acceleration can be at least 1500g for any of the above. In at least one embodiment, the minimum acceleration can be at least 1600g for any of the above. In at least one embodiment, the minimum acceleration can be at least 1700 g for any of the above. In at least one embodiment, the minimum acceleration can be at least 1800g for any of the above. In at least one embodiment, the minimum acceleration can be at least 1900g for any of the above. In at least one embodiment, the minimum acceleration can be at least 2000g for any of the above. At least for the above embodiments, "g" is based on a gravitational acceleration ^{of about 9.8 m / s 2 at the Earth's sea level.}

Optionally, the sample is centrifuged for at least about 1 minute. Optionally, the sample is centrifuged for at least about 2 minutes. Optionally, the sample is centrifuged for at least about 3 minutes. Optionally, the sample is centrifuged for at least about 4 minutes. Optionally, the sample is centrifuged for at least about 5 minutes. Optionally, the sample is centrifuged for at least about 6 minutes. Optionally, the sample is centrifuged for at least about 7 minutes. Optionally, the sample is centrifuged for at least about 8 minutes. Optionally, the sample is centrifuged for at least about 9 minutes. Optionally, the sample is centrifuged for at least about 10 minutes. In some embodiments, the first centrifugation step is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes at the desired rate or rate range described in the paragraph above. Has a minimum value of 8 minutes, 9 minutes, or 10 minutes, and a maximum value of 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, or 11 minutes. It can be done for a period of time selected from the range.

Optionally, the first or first separation step for separating plasma from red blood cells occurs within 5 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 10 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 15 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 20 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs less than 5 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs less than 10 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs less than 15 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs less than 20 minutes after the sample is collected in the sample container.

Optionally, a secondary centrifugation step, such as, but not limited to, centrifuging spins, is performed to keep the post-transport sample horizontal to the receiving location. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 43% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 40% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 30% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 25% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 20% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 15% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 12.5% of the gravitational acceleration of the first centrifugation. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifugation is less than about 10% of the gravitational acceleration of the first centrifugation.

In one embodiment, this secondary or subsequent spin is less than 1400 g. In one embodiment, this secondary or subsequent spin is less than 1300 g. In one embodiment, this secondary or subsequent spin is less than 1200 g. In one embodiment, this secondary or subsequent spin is less than 1100 g. In one embodiment, this secondary or subsequent spin is less than 1000 g. In one embodiment, this secondary or subsequent spin is less than 900 g. In one embodiment, this secondary or subsequent spin is less than 800 g. In one embodiment, this secondary or subsequent spin is less than 700 g. In one embodiment, this secondary or subsequent spin is less than 600 g. In one embodiment, this secondary or subsequent spin is less than 500 g. In one embodiment, this secondary or subsequent spin is less than 400 g. In one embodiment, this secondary or subsequent spin is less than 300 g. In one embodiment, this secondary or subsequent spin is less than 200 g. In one embodiment, this secondary or subsequent spin is less than 100 g. In at least one embodiment, the minimum gravitational acceleration can be at least 10 g for any of the above. In at least one embodiment, the minimum gravitational acceleration can be at least 20 g for any of the above. In at least one embodiment, the minimum gravitational acceleration can be at least 30 g for any of the above. In at least one embodiment, the minimum gravitational acceleration can be at least 40 g for any of the above. In at least one embodiment, the minimum gravitational acceleration can be at least 50 g for any of the above. As a non-limiting example, in one embodiment, the secondary spin is about 500 g or less, but at least more than 10 g. Optionally, in one embodiment, the secondary spin is no more than about 500 g, but more than at least 20 g. Optionally, in one embodiment, the secondary spin is no more than about 500 g, but more than at least 30 g. Optionally, in one embodiment, the secondary spin is no more than about 500 g, but more than at least 40 g. Optionally, in one embodiment, the secondary spin is no more than about 500 g, but more than at least 50 g. As a non-limiting example, in one embodiment, the secondary spin is about 400 g or less, but at least more than 10 g. Optionally, in one embodiment, the secondary spin is less than or equal to about 400 g, but more than at least 20 g. Optionally, in one embodiment, the secondary spin is less than or equal to about 400 g, but more than at least 30 g. Optionally, in one embodiment, the secondary spin is less than or equal to about 400 g, but more than at least 40 g. Optionally, in one embodiment, the secondary spin is less than or equal to about 400 g, but more than at least 40 g.

As a non-limiting example, in one embodiment, the secondary spin is about 500 g or less, but sufficient to form a horizontal, substantially flat meniscus for the sample in the vessel. It exceeds the minimum. The upper bound forms something during the second centrifugation because too much gravitational acceleration can cause the fluid or substance of the internal cells to rupture or leak into the plasma of the sample, which can alter the results. It can be selected so as not to over-compress the resulting blood components. The lower bound can be selected so that a horizontal, substantially flat meniscus can be formed on the sample in the vessel. In one embodiment, when processing a volume of about 10 to about 100 microliters, this substantially flat, non-angled surface can facilitate aspiration of the sample in an accurate and reproducible manner. In one embodiment, when processing a volume of about 20 to about 150 microliters, this substantially flat, non-angled surface can facilitate aspiration of the sample in an accurate and reproducible manner. In one embodiment, when processing a volume of about 30 to about 200 microliters, this substantially flat, non-angled surface can facilitate aspiration of the sample in an accurate and reproducible manner. Non-flat or angled menisci can cause problems with partial suction. Optionally, the meniscus can be on a plane substantially perpendicular to the vertical axis of the vessel (like a horizontal plane perpendicular to the vertical axis of the vessel when the vessel maintains a vertical orientation).

Optionally, the time interval for the secondary centrifugation is about the same as for the first centrifugation. Optionally, the time interval for the secondary centrifugation is less than that for the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 50% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 40% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 30% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 20% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-50% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-40% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5 to 33% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-30% of the first centrifugation.

Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 30% of the first centrifugation, and after the sample has been transported from the first position to the second position. Occurs. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 35% of the first centrifugation, and after the sample has been transported from the first position to the second position. Occurs. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 40% of the first centrifugation, and after the sample has been transported from the first position to the second position. Occurs. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 50% of the first centrifugation, and after the sample has been transported from the first position to the second position. Occurs.

Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 50% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 40% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 30% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 20% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 500 g.

Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 50% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 40% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 30% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifugation is about 5% to about 20% of the first centrifugation, and after the sample has been transported from the first position to the second position. As a result, the secondary centrifugation does not exceed about 400 g.

Secondary spin after sample transport can be used to keep the / plasma level level and lower the plasma adhering to the cap and sidewalls of the sample container (so sample loss is Not), and move, as well as move the fibrin mass out of plasma. This ensures optimal use of the sample (without loss), accurate imaging of the sample, and sample volume calculation, as well as efficient suction of the sample from the sample container.

Optionally, in some embodiments, the non-centrifugation second step is a shaker, tapper, but not limited, to facilitate the sample on the cap to rejoin other sample portions in the container. , Inverters, other non-centrifugation mechanical methods can be used, or any single or combination of the above to move the sample into the container from the cap or side wall of the sample container. Can be used.

In an embodiment, the process provided herein is to transport a blood sample at a sample collection site, and then this blood sample from the sample collection site to an analytical site located at a location different from the sample collection site. Can include. Similarly, analytical sites may receive blood samples collected at different sample collection sites. In such embodiments, the blood sample or portion thereof can be centrifuged at the sample collection site and then again after arriving at the analysis site. In embodiments, centrifugation of the blood sample at the sample collection site can facilitate the separation of blood into i) plasma or serum and 2) formed components (eg, red blood cells). In an embodiment, a gel-like substance can be provided in a container for blood, so that during centrifugation of the blood in the container, a gel layer from the components formed in the blood collector. Separates the plasma or serum layer. In embodiments, centrifugation of the blood sample at the analytical site may facilitate the movement of the blood sample in the container towards the bottom of the container (eg, off the cap of the container or under the wall).

In one embodiment, the time interval between centrifugation of the blood sample at the sample collection site and centrifugation at the analysis site is at least about 1 hour. Optionally, the time interval is at least about 2 hours. Optionally, the time interval is at least about 3 hours. Optionally, the time interval is at least about 4 hours. Optionally, the time interval is at least about 5 hours. Optionally, the time interval is at least about 6 hours. Optionally, the time interval is at least about 7 hours. Optionally, the time interval is at least about 8 hours. Optionally, the time interval is at least about 9 hours. Optionally, the time interval is at least about 10 hours. Optionally, the time interval is at least about 11 hours. Optionally, the time interval is at least about 12 hours. Optionally, the time interval is at least about 13 hours. Optionally, the time interval is at least about 14 hours. Optionally, the time interval is at least about 15 hours. Optionally, the time interval is at least about 16 hours. Optionally, the time interval is at least about 17 hours. Optionally, the time interval is at least about 18 hours. Optionally, the time interval is at least about 19 hours. Optionally, the time interval is at least about 20 hours. Optionally, the time interval is at least about 21 hours. Optionally, the time interval is at least about 22 hours. Optionally, the time interval is at least about 23 hours. Optionally, the time interval is at least about 24 hours. Optionally, the time interval is at least about 28 hours. Optionally, the time interval is at least about 32 hours. Optionally, the time interval is at least about 36 hours. Optionally, the time interval is at least about 40 hours. Optionally, the time interval is at least about 44 hours. Optionally, the time interval is at least about 48 hours.

In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3000 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3100 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3200 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3300 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3400 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3500 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3550 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3575 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3700 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3800 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3900 g. In one embodiment, centrifugation of the blood sample at the sample collection site comprises centrifuging at least 3950 g. Optionally, the sample is centrifuged for at least about 1 minute. Optionally, the sample is centrifuged for at least about 2 minutes. Optionally, the sample is centrifuged for at least about 3 minutes. Optionally, the sample is centrifuged for at least about 4 minutes. Optionally, the sample is centrifuged for at least about 5 minutes. Optionally, the sample is centrifuged for at least about 6 minutes. Optionally, the sample is centrifuged for at least about 7 minutes. Optionally, the sample is centrifuged for at least about 8 minutes. Optionally, the sample is centrifuged for at least about 9 minutes. Optionally, the sample is centrifuged for at least about 10 minutes.

Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 43% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 40% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 30% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 25% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 20% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 15% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 12.5% of the gravitational acceleration of centrifugation at the sample collection site. Optionally, the gravitational acceleration of centrifugation at the analysis site is less than about 10% of the gravitational acceleration of centrifugation at the sample collection site.

In one embodiment, the centrifugation at the analytical site is less than 1400 g. In one embodiment, the centrifugation at the analysis site is less than 1300 g. In one embodiment, the centrifugation at the analysis site is less than 1200 g. In one embodiment, the centrifugation at the analytical site is less than 1100 g. In one embodiment, the centrifugation at the analytical site is less than 1000 g. In one embodiment, the centrifugation at the analysis site is less than 900 g. In one embodiment, the centrifugation at the analysis site is less than 800 g. In one embodiment, the centrifugation at the analysis site is less than 700 g. In one embodiment, the centrifugation at the analysis site is less than 600 g. In one embodiment, the centrifugation at the analysis site is less than 500 g. In one embodiment, the centrifugation at the analytical site is less than 400 g. In one embodiment, the centrifugation at the analysis site is less than 300 g.

Optionally, the time interval for centrifugation at the analysis site is approximately the same as for centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analytical site is shorter than that at the sampling site. Optionally, the time interval for centrifugation at the analytical site is less than 50% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analytical site is less than 40% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analytical site is less than 30% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analytical site is less than 20% of the centrifugation at the sample collection site. In at least some embodiments, the healthcare provider (or their staff, as appropriate) can be the sample collector, the recipient of the test results, and / or both. For example, in one embodiment, a health care professional, such as a dentist, collects samples, but not as limited, as part of or as a separate dental procedure. Optionally, some embodiments may have samples from blood and / or saliva aspirated from the subject's dental procedure. The collected samples are processed at the dental office and / or shipped to a receiving location where multiple samples are received for processing.

In embodiments, fluid samples used in the systems, devices, or methods provided herein can be diluted. In embodiments, the fluid sample can be diluted before it is transported from the first location to the second location. In embodiments, the fluid sample can be diluted after it has been transported from the first location to the second location. In embodiments, the fluid sample can be diluted both before and after it is transported from the first location to the second location. In an embodiment, the fluid sample is used after it has been transported from a first location to a second location and to perform one or more steps of a clinical examination at the second location. Diluted before. The original samples are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, It can be diluted 50,000 or 100,000 times. As used herein, "n-fold dilution" refers to the rate at which the original sample is diluted-for example, a 5-fold diluted original sample is 1/5 of the original concentration after dilution. Contains the original sample (ie, the diluted sample contains 1/5 of the concentration of the sample in the original sample); similarly, the original sample diluted 500-fold is after dilution. Includes the original sample at 1/500 of the original concentration. Thus, for example, if the original sample contains 5 mg / microliter of protein and it is diluted 2-fold, the diluted sample contains 2.5 mg / microliter of protein. The body fluid sample can be divided into any number of parts, and the various parts can be diluted to different degrees of dilution, and the original body fluid sample can be a multi-diluted sample. It can be processed to produce, each with a different degree of dilution. Thus, for example, the original fluid sample can be divided into 5 parts, one part diluted 8 times, another part diluted 12 times, and another part diluted 3 times. , Another portion is diluted 400-fold, and another portion is diluted 2,000-fold. The dilution of the sample can be done sequentially in a single step. For single-step dilution, a selected amount of sample can be mixed with a selected amount of diluent to achieve the desired dilution of the sample. For sequential dilution, two or more individual sequential dilutions of the sample may be performed to achieve the desired dilution of the sample. For example, the first dilution of the sample can be carried out, and a portion of the first dilution can be used as an input material for the second dilution to produce a sample of the selected dilution level.

For the dilutions described herein, "original sample" and the like refer to the sample used to initiate a predetermined dilution process. Thus, the "original sample" is a sample obtained directly from the subject (eg, whole blood), while any other sample used as a starting material for a given dilution procedure (eg, processed). , Or samples already diluted in separate dilution procedures) may also be included.

In some embodiments, sequential dilution of the sample can be performed as follows. A selected amount (eg, volume) of the original sample can be mixed with the selected amount of diluent to produce the first diluted sample. The first diluted sample (and any subsequent diluted sample) is: i) sample dilution factor (eg, the amount by which the original sample is diluted into the first diluted sample) and ii) initial amount. (For example, the total amount of the first diluted sample present after the selected amount of the original sample and the selected amount of diluent have been mixed). For example, to produce a first diluted sample with a 5-fold sample diluent (as compared to the original sample) and an initial volume of 50 microliters, a 10 microliter original sample is 40 microliters. Can be mixed with diluent. A selected amount of the first diluted sample can then be mixed with the selected amount of diluent to produce a second diluted sample. For example, to produce a second diluted sample with a 100-fold sample dilution factor (as compared to the original sample) and an initial volume of 100 microliters, the 5 microliter first diluted sample is 95. Can be mixed with microliter diluent. For each of the above dilution steps, the original sample, dilution sample, and diluent can be stored or mixed in a fluidly separated container. Sequential dilution can be continued for the required number of steps until the selected sample dilution level / dilution factor is reached in the preceding fashion. In embodiments, the sample is in, for example, U.S. Patent Application No. 13 / 769,820, filed February 18, 2013, or any other document incorporated by reference in other parts of the specification. Can be diluted as described.

As used herein, a reagent, or one that can be used as a "diluent," is, for example, a formulation that is useful for increasing the volume of a sample, a portion of a sample, or is reconstituted after lyophilization. Or useful for the preparation of a liquid formulation for adding a solution or substance to a sample for any other reason. In embodiments, the diluent can be buffered (eg, having a pH close to or close to pH 7.4, pH, or other desired pH) and can be pharmaceutically acceptable (to humans). Safe and non-toxic in administration). Diluents typically do not react or bind to the sample in the sample. Water can be a diluent, such as an aqueous saline solution, a buffered solution, a solution containing a surfactant, or any other solution. Exemplary diluents include sterile water, bacteriostatic water for injection (BWFI), pH buffered solution (eg, phosphate buffered saline), sterile saline solution, Ringer solution or dextrose solution. .. In embodiments, the diluent may include an aqueous solution of salt or buffer.

In embodiments, by the system or method provided herein, for example, a body fluid sample or portion thereof collected, processed, or transported from a subject is at least 2, 3, 4, 5, 6. , 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more divided into different parts Can be done. For division of a sample into multiple parts, the "original sample" etc. provided herein refers to the sample used to initiate a predetermined division process. Thus, an "original sample" is a sample obtained directly from a subject (eg, whole blood), while any other sample used as a starting material for a given division procedure (eg, processed). , Or samples already diluted in separate division procedures) may also be included. In embodiments, the "original sample" can be attached to both the sample dilution and dilution steps; in such situations, the reference to the "original sample" is a sample dilution / sample dilution procedure. Refers to the starting material used for the combination of. When the sample is divided into different parts, the different parts may contain different amounts of the original sample. For example, if an original sample with a volume of 100 microliters is divided into 5 parts, one part can contain the original sample of 50 microliters and the other part of the original 25 microliters. Can contain samples, another part can contain 15 microliters of the original sample, another part can contain 8 microliters of the original sample, and the last part can contain 2 microliters. The original sample can be included. Similarly, when a sample undergoes both dilution and division into different parts, the different parts can have different degrees of dilution with respect to the original sample. For example, when the original sample is divided into three parts, one part is diluted 5 times with respect to the original sample and the other part is diluted 20 times with respect to the original sample. , And the third portion can be diluted 200-fold with respect to the original sample.

Thus, in one example, fluid samples can be collected from the subject at a primary location (eg, a sample collection site). The fluid sample initially collected from the subject is considered the "original sample". The "original sample" can be, for example, a small amount of whole blood (eg, less than 400, 300, 200, or 100 microliters) from said subject. Shortly after or at the same time as collecting the "original sample" from the subject, the "original sample" can be divided into at least the first and second parts, after which, The first part is moved into the first container, and the second part is moved into the second container. In embodiments, the first container can contain a first anticoagulant (eg, EDTA), and the second container is a second anticoagulant (eg, heparin). The first and second containers may be transported from the first location to the second location by the system or method provided herein. In the embodiment, at the second location, the sample, or portion thereof, in one or both of the containers is subject to further processing or analysis steps. For example, the sample, or portion thereof, in one or both of the containers may be divided into additional portions, diluted, and / or used to perform one or more tests.

In another embodiment, the systems and methods provided herein are used to ship fluid samples in a container from a first location to a second location. The bodily fluid sample in the container can be the whole or a portion of the sample collected from the subject. At the second location, at least some of the fluid samples in the container can be removed from the container and used for sample splitting and / or dilution procedures. The sample removed from the container and used in the sample splitting and / or dilution procedure can be considered the "original sample". The original sample can be, for example, whole blood, plasma, serum, saliva, or urine, and can constitute the whole or part of the sample transported in the container. The original sample can be divided into any number of parts; the various parts may have different degrees of dilution with respect to the original sample. For example, the original sample removed from the transported container is 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, ,. It can have a volume of 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliter or less. The original sample removed from the transported container is then at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100. , 200, 300, 400, 500, 1000, 5,000, 10,000 or more can be divided into different parts. In embodiments, the different moieties may have different degrees of dilution with respect to the original sample. For example, the different moieties are at least a few, provided that the number of moieties with different degrees of dilution with respect to the original sample does not exceed the total number of moieties prepared from the original sample. 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, or 5,000 dilutions of different degrees Can have. The different moieties are, for example, undiluted, at least 2-fold diluted, at least 3-fold diluted, at least 5-fold diluted, at least 10-fold diluted, at least 20-fold diluted, at least 50-fold diluted, at least 100, relative to the original sample. It can have any type of dilution, including double dilution, at least 500-fold dilution, at least 1000-fold dilution, at least 5000-fold dilution, at least 10,000-fold dilution, at least 50,000-fold dilution, or at least 100,000-fold dilution. .. In embodiments, one or more different parts of the original sample can be used for clinical examination. In embodiments, one portion of the original sample can be used for clinical testing. One portion of the original sample used for clinical testing can be a diluted sample.

In embodiments, the original sample can be a whole blood sample collected from a subject. The original sample can be obtained from the subject's finger. The original samples are 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, It can have a volume of less than 3, 2, or 1 microliter. The original sample can be divided into multiple parts. The division of the sample into multiple parts is a combination of before, after, or before and after the sample is transported from the first location to the second location by the system or method provided herein. Can be done by. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500 of the original sample. , 1000, 5,000, 10,000 or more can be divided into different parts, and said different parts are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15 , 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 used in different clinical tests. Different parts of the original sample may have a diluted original sample. In the embodiment, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0. The original sample, less than 3, 0.2, 0.1, 0.05, or 0.01 microliter, is used for each clinical test.

In embodiments, the original sample can be plasma or serum obtained from a whole blood sample taken from a subject. The whole blood can be obtained from the subject's finger. The whole blood sample from which the plasma or serum is obtained is 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7 , 6, 5, 4, 3, 2, or can have a volume of less than 1 microliter. The original samples of plasma or serum are 300,200,150,100,90,80,70,60,50,40,30,25,20,15,10,9,8,7,6,5, It can have a volume of less than 4, 3, 2, or 1 microliter. The original sample can be divided into multiple parts. The division of the sample into multiple parts is a combination of before, after, or before and after the sample is transported from the first location to the second location by the system or method provided herein. Can be done by. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500 of the original sample. , 1000, 5,000, 10,000 or more can be divided into different parts, and said different parts are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15 , 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 used to perform different clinical tests. Different parts of the original sample may have a diluted original sample.

In the embodiment, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0. Equivalent to the original sample of less than 3, 0.2, 0.1, 0.05, or 0.01 microliters is used for clinical examination. For example, the original sample is whole blood, and the original sample is divided into multiple parts, and includes a diluted sample containing the original sample in which at least one of the parts is diluted 100-fold, and If 5 microliters of the diluted sample are used to perform a clinical test, a 0.05 microliter equivalent of the original sample (eg, whole blood) is used for the test (5 microliters). x1 / 100 dilution). In another example, the original sample can be whole blood. The whole blood can be processed to produce plasma [eg, by separating the liquid component of the blood from the solid component of blood (eg, cells)]. A specific volume of plasma can be obtained from a specific volume of whole blood. -For example, the volume of plasma obtained from the volume of whole blood can be, for example, at least or about 30%, 40%, 50%, 60%, or 70% of the total blood volume. Thus, for example, if the volume of the plasma from whole blood is 50%, 1 mL of plasma can be obtained from 2 mL of whole blood. The plasma from whole blood can be further diluted, and one or more diluted portions of the plasma can be used to perform one or more clinical tests. In another example, the original sample can be whole blood. The whole blood is processed to produce plasma, and the volume of plasma from the whole blood is 60% of the whole blood (eg, from 100 microliters of whole blood, 60 microliters of plasma is obtained. ). The plasma can be diluted 10-fold. 2 microliters of the diluted plasma can be used to perform a clinical test. Therefore, for that clinical test, an equivalent of about 0.33 microliters of the original sample (whole blood) is used to carry out the test (2 microliters x 1/10 dilution x 100/60 whole blood /). Plasma conversion). In another example, the original sample can be plasma, and the original sample is divided into multiple parts, and at least one of the parts comprises the original sample diluted 50-fold. A 0.08 microliter equivalent of the original sample (eg, plasma) is said to contain the diluted sample, and 4 microliters of the diluted sample are used to perform a clinical test. Used for testing (4 microliters x 1/50 dilution).

In embodiments, the original sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, Divided into 500, 1000, 5,000, 10,000 or more parts, with different parts at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, It can be used to perform 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different clinical tests. In some embodiments, at least as many sample parts as the number of sample parts on which the clinical test is performed are prepared (eg, said original to perform 10 clinical tests with the original sample). The sample is divided into at least 10 parts and at least 1 part is used per test). In certain other embodiments, more than one laboratory test can be performed with a single sample. For example, in embodiments, the optical properties of a sample can be measured (eg, cell counting in a blood sample), and then the same sample can be used to test the sample in blood. Thus, in some embodiments, more clinical tests can be performed with the original sample than the number of parts prepared from the same original sample (eg, 10 clinical tests are divided into 8 parts). Can be carried out from the original sample).

If the original sample is divided into multiple parts, and the multiple parts are used to perform more than one laboratory test, the laboratory test is the same type of laboratory test, or they are It can be a different type of laboratory test. For example, if the original sample is divided into 10 parts and each of the 10 parts is used for a clinical test, the clinical test performed by each of the parts can be an immunological test. In another example, if the original sample is divided into 5 parts, and each of the 5 parts is used for a clinical test, the clinical test performed by each of the parts is a test that follows nucleic acid amplification. obtain.

In other cases, if the original sample is divided into multiple parts, and if the multiple parts are used to perform more than one clinical test, then at least two of the clinical tests are of different types. Can be a clinical test. For example, if the original sample is divided into 5 parts, and each of the 5 parts is used for clinical examination, 2 of the parts can be used for an immunoassay (eg, ELISA), and said. Three of the moieties can be used for testing based on nucleic acid amplification.

Body fluid samples or parts thereof provided herein, transported by a system or method, are used for various types of clinical tests such as immunoassays, nucleic acid amplification tests, general chemistry tests, or hemocytometer tests. Can be. In embodiments, the body fluid sample or portion thereof, transported by the system or method provided herein, is, for example, filed on February 18, 2013, US Patent Application No. 13 / 769,820. , Or, as described elsewhere in this specification, in any other document incorporated by reference, may be used in any type of assay or clinical examination.

In some embodiments, fluid samples or portions thereof, transported by the systems or methods provided herein, can be used for immunological tests. As used herein, "immunological test" refers to any test, including probing a sample, with an antibody that has an affinity for the sample. Immunological tests can include, for example, enzyme-linked immunosorbent assay adsorption (ELISA) tests, and can include competitive and non-competitive based tests. As used herein, the term "antibody" refers to an immunoglobulin molecule and an immunologically active portion of the immunoglobulin molecule, i.e., an antigen-binding unit that specifically binds to an antigen ("initiates an immune response"). Refers to a molecule containing "Abu" or plural "Abus"). Structurally, the simplest native antibody (eg, IgG) comprises four polypeptide chains, two heavy (H) chains and two light (L) chains, interconnected by disulfide bonds. Immunoglobulins represent a large family of molecules, including diverse molecules such as IgD, IgG, IgA, IgM, and IgE. The term "immunoglobulin molecule" includes, for example, hybrid antibodies, or converted antibodies, and fragments thereof. Antigen binding units can be broadly divided into "single strands" ("Sc") and "non-single strands" ("Nsc") based on their molecular structure.

Further, terms such as "antibody" and "antigen binding unit" include human, non-human (from spine or invertebrate), chimeric, humanized immunoglobulin molecules and fragments thereof. For a description of chimeric and humanized antibodies, see Clark et al., 2000 and the references cited therein: (Clark, (2000) Immunol. Today 21: 397-402). Chimeric antibodies include variable regions of non-human antibodies, eg, VH and VL regions of rat or mouse origin are operably linked to constant regions of human antibodies (see US Pat. No. 4,816,567). I want to be). In embodiments, the "immunological assay" provided herein is that the sample to be measured in the assay is an antibody, and that antibody is a molecule with which the antibody has an affinity (eg, said. Also includes tests probed by antibody target molecules).

In some embodiments, body fluid samples or portions thereof, transported by the systems or methods provided herein, can be used in nucleic acid amplification tests. As used herein, "nucleic acid amplification test" refers to one in which the number of copies of the target nucleic acid can be increased. Nucleic acid amplification tests can include both isothermal and temperature variable amplification techniques, and can include techniques such as polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP). Typically, a nucleic acid amplification test comprises at least i) a nucleic acid polymerase, ii) a primer capable of binding to the target diffusion sequence, and iii) a free nucleic acid that can be integrated by the polymerase into the synthesized nucleic acid. Amplification of the target nucleic acid can be detected by various methods such as measuring the fluorescence or turbidity of the reaction over time.

In some embodiments, body fluid samples or portions thereof, transported by the systems or methods provided herein, can be used in general chemistry assay. General chemical tests include, for example, the basal metabolism test panel [glucose, calcium, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, blood nitrogen urea (BUN). )], Electrolyte test panel [sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate], Chem14 test panel / integrated metabolism panel [glucose, calcium, albumin, total protein] , Sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, blood nitrogen urea (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT / GPT), aspartate aminotransferase (AST / GOT), total bilirubin], lipid profile / lipid panel test [LDL cholesterol, HDL cholesterol, total cholesterol, and triglyceride], liver panel / liver function test [alkaline phosphatase (ALP), Alanine aminotransferase (ALT / GPT), aspartate aminotransferase (AST / GOT), total bilirubin, albumin, total protein, γ-glutamine transpeptidase (GGT), lactate dehydrogenase (LDH), prothrombin time (PT) ], Alkaline phosphatase (APase), hemoglobin, VLDL cholesterol, ethanol, lipase, pH, zinc protoporphyrin, direct bilirubin, blood type (ABO, RHD), lead, phosphate, hemagglutination inhibition, magnesium, iron, iron intake , Fecal occult blood, and others, individually or in any combination.

In some examples in the general chemistry assay provided herein, the level of the sample in the sample reacts with one or more reagents of the sample of interest to produce a detectable change (eg,). , Changes in turbidity of the reaction, generation of luminescence in the reaction, changes in color of the reaction, etc.). In some examples, the nature of the sample reacts with one or more reagents of the sample of interest to produce a detectable change (eg, a change in the turbidity of the reaction, the production of luminescence in the reaction). , Such as the color change of the reaction), determined by one or more assay steps. Typically, as used herein, the "general chemistry" assay is in solution based on nucleic acid amplification, imaging of cells on a microscopy platform, or the use of labeled antibodies / binders. Does not include determination of sample level. In some embodiments, the general chemistry assay is performed with all reagents in a single vessel-ie, all necessary reagents are added to the reaction vessel to carry out the reaction, and said. During the course of the assay, the substance is not removed from the reaction or reaction vessel (eg, there is no wash step; it is a "mixing and reading" reaction). The general chemical test can also be, for example, a colorimetric test, an enzymatic test, a spectroscopic test, a turbidity test, an aggregation test, a coagulation test, and / or other types of tests. Many general chemistry tests can be analyzed by measuring the absorbance of light at one or more selected wavelengths by the test reaction (eg, by a spectrometer). In some embodiments, the general chemical assay can be analyzed by measuring the turbidity of the reaction by the assay reaction (eg, by a spectrometer). In some embodiments, the general chemical assay can be analyzed by measuring the chemiluminescence produced by the reaction (eg, by PMT, photodiode, or other optical sensor). In some embodiments, the general chemical assay can be performed computationally based on experimental values determined for one or more other specimens in the same or related assay. In some embodiments, the general chemical assay can be analyzed by measuring the fluorescence of the reaction (eg i) a light source of a particular wavelength (“excitation wavelength”); and ii) radiated at a particular wavelength. A detection unit that includes or is connected to sensors configured to detect light (“radiation wavelength”). In some embodiments, the general chemical assay can be analyzed by measuring the agglomeration of the reaction (eg, by measuring the turbidity of the reaction with a spectrometer, or by imaging the image of the reaction with an optical sensor. By getting). In some embodiments, the general chemical assay can be analyzed by imaging the reaction (eg, by a CCD or CMOS optical sensor) at one or more time points and then performing image analysis. Optionally, the analysis can include prothrombin time, activated partial thromboplastin time (APTT), both of which can be measured by methods such as, but not limited to, turbidimetry. In some embodiments, the general chemical assay can be analyzed by measuring the viscosity of the reaction (eg, if the viscosity of the reaction changes the optical properties of the reaction, eg, by a spectrometer). In some embodiments, a general chemical assay can be analyzed by measuring the formation of a complex between two non-antibody reagents (eg, metal ion vs. chromophore; such reactions are measured spectrometers. Or by colorimetric analysis using another instrument). In some embodiments, the general chemical assay can be analyzed by ELISA or a method of assaying cellular antigens by a non-hemocytometer method (eg, hemagglutination for blood group, which can be measured by the turbidity of the reaction. Test). In some embodiments, the general chemical assay can be analyzed with the assistance of an electrochemical sensor (eg, for carbon dioxide or oxygen). Additional methods may also be used to analyze the general chemical assay.

In some embodiments, a spectrometer can be used to measure the general chemical assay. In some embodiments, the general chemistry test can be measured at the end of the test (“end point” test) or at two or more times during the course of the test (“change over time”). Or a "dynamic" test).

In some embodiments, fluid samples or portions thereof, transported by the systems or methods provided herein, can be used in hemocytometer testing. Hemocytometers are typically used to measure the properties of individual cells optically, electrically, or acoustically. For the purposes of the present disclosure, "cells" are, but are not limited to, cysts (such as liposomes), small groups of cells, viral particles, bacteria, protozoa, crystals, lipids and / or masses due to aggregation of proteins. , And samples of generally similar size to individual cells containing substances bound to small particles such as beads, nanoparticles, or microspheres. Properties include, but are not limited to: size; shape; grain size; light scattering pattern (or optical refractive ellipse); whether the cell membrane is perfect; concentration; morphology and not limited. Protein content, protein modification, nucleic acid content, nucleic acid modification, organella content, nuclear structure, nuclear content, internal cell structure, internal capsule content (including pH), ion concentration, and steroids or drugs. The presence of small molecules such as; and the spatiotemporal distribution of cell internal contents such as cell surface (both cell membrane and wall) markers containing proteins, lipids, carbohydrates, and their modifications. By using suitable dyes, stains, or other labeled molecules in pure form, conjugated to other molecules, immobilized in other molecules, or attached to nano- or micro-particles. , Blood cell counts can be used to determine the presence, amount, and / or modification of a particular protein, nucleic acid, lipid, carbohydrate, or other molecule. Colorimetric analysis can be done, for example, by flow cytometry or by microscopy. Flow cytometry typically uses a mobile liquid medium that sequentially brings individual cells to an optical, electrical or acoustic detector. Microscopy typically uses optical or acoustic means to detect immobile cells by generally recording at least one magnified image. In embodiments, the hemocytometer test may include obtaining images of one or more cells in a sample. In embodiments, the sample can be provided on or in a microscope slide or cuvette that allows the cells in the sample to settle in the desired orientation for imaging. For example, a camera based on CCD or CMOS can obtain images of cells.

In some embodiments, the types of clinical tests are categorized based on how the results of the tests are detected. Detection of different types of laboratory results may include, for example, i) luminescence detection; ii) fluorescence detection; iii) absorbance detection; iv) light scattering detection; and v) imaging. Each of these detection methods is described, for example, in U.S. Patent Application No. 13 / 769,820, filed February 18, 2013, which is incorporated herein by reference in its entirety. To. Briefly, luminescence can be detected by tests that produce measurable optical signals. Such a reaction can be, for example, a chemiluminescent reaction. To detect the result of the luminescent reaction, a photodetector such as a PMT or photodiode can be used to detect the light from the test unit containing the luminescent reaction. Fluorescence can be detected, for example, by optical settings including a light source and a photodetector. The light source may emit light of a specific wavelength. The test unit containing the test substance can be present in the optical path of the light source so that light of the particular wavelength (“excitation wavelength”) can reach the contents of the test unit. The test unit may contain a molecule of interest that, under at least some circumstances, absorbs light of a particular wavelength from said light source and then emits light of a different wavelength. The photodetector may be configured to detect light emitted from the molecule of interest (“radiation wavelength”). The light source and / or photodetector installs a bandpass filter after the light source or before the photodetector to limit the light of the wavelength from the light source from reaching the photodetector. Can include. The light source can be, for example, a light bulb, a laser or an LED, and the photodetector can be, for example, a PMT or a photodiode. Absorbance can be detected by optical settings, including, for example, a light source and a photodetector. The light source and the photodetector can be in line with each other, and the light can pass through the test substance to reach the photodetector, and some light can be absorbed. A verification unit containing the test substance may be configured to be between the light source and the photodetector. Based on the results of the test, different amounts of light can be absorbed by the test substance. Similarly, the transmission of light passing through the test substance can be determined. For the assay for determining absorbance / transmittance, the wavelength of light emitted by the light source can be the same as the wavelength of light detected by the photodetector. The light source can be, for example, a light bulb, a laser or an LED, and the photodetector can be, for example, a PMT or a photodiode. Light scattering can be detected by optical settings, including, for example, a light source and a photodetector. The light source and the light detector can be present at a constant angle to each other, and the light can pass through the test substance and reach the test unit in order to reach the light detector, and said. The test unit containing the test substance under test may be configured to be in line with both the light source and the light detector so that the light in the test unit can be scattered. Based on the results of the test, different amounts of light may be scattered by the test material. The light source can be, for example, a light bulb, a laser or an LED, and the photodetector can be, for example, a PMT or a photodiode. Images of the test substance can be obtained, for example, by a detector that includes an image sensor (eg, a CCD or CMOS sensor). Typically the image sensor can be included in the camera. Images of test substances can be analyzed, for example, by automated or manual image analysis to determine test results. The body fluid samples provided herein are based on non-optical detection methods. It can also be used in clinical tests (eg, measurement of conductivity, radioactivity, or temperature) to detect the results.

In an embodiment, the body fluid sample portion is moved into the test unit for at least one step of the test / test in order to carry out the test / test. The test unit can have various morphological factors such as pipette tips, tubes, or microscope slides. One of the assay steps that can be performed in the assay unit is, for example, binding of the sample in the sample to a binder (eg, an antibody against the sample), amplification of the target nucleic acid in the sample by a nucleic acid amplification reaction, and one to the sample. Coagulation of the sample based on the addition of the above reagents, or settling on the surface of a microscope slide to facilitate the acquisition of one or more images of said cells, eg, a sample that takes shape for optical analysis. Cells) can be included. As used herein, the terms "test" and "test" may be used interchangeably unless the context explicitly indicates something else.

Examples The following examples are provided for descriptive purposes only and are not intended to limit this disclosure in any way.

Example 1

Whole blood samples were obtained from the subjects. The whole blood sample was centrifuged in a container to separate the whole blood into pelletized cells and plasma supernatant. The centrifuged container was transferred to a glove box ventilated with argon. Plasma is aspirated from the centrifuge vessel and then divided into 5 equal parts in a separate sample vessel note provided herein, each of which has an internal volume of less than 100 microliters. Having less than 95 microliters of plasma was equally divided into each sample vessel, and each of the sample vessels was of the same size and received the same volume of plasma. Each of the containers had a removable butyl rubber cap. The five sample containers were labeled "0 hours", "1 hour", "2 hours", "8 hours", and "24 hours" during the period associated with each sample container. The sample in each container was tested for bicarbonate. The results of the test are provided in Table 1 of the tongue.

As shown in Table 1, the bicarbonate in the sample was stable for at least 24 hours in the sample container provided herein.

Example 2

Whole blood samples were obtained from the subjects. EDTA was mixed with the whole blood sample. Eighty microliters of blood containing the EDTA are equally differentiated into each of the ten sample containers provided herein, each of which has an internal volume of less than 100 microliters and the same size. had. The sample vessels were labeled as follows for analysis: real-time: 1, 2, 3, 4, 5, and 7; before centrifugation: 1, 2, 4, and 7. .. Each of the "pre-centrifugation" vessels was centrifuged at a time when the sample was equidistant in the vessel to produce plasma and pelletized cells. Each of the "real-time" vessels was centrifuged each day to produce plasma and pelletized cells. After the samples were equi-differentiated into their respective sample containers, they were capped. For each container, plasma was removed from the container on each day and tested for blood nitrogen urea (BUN). The result of the BUN test is shown in the graph in FIG. As shown in the graph, in the samples in the sample containers provided herein, BUN was stable in both whole blood and plasma samples for at least 7 days.

Publications discussed or cited herein are provided solely as disclosure prior to the filing date of this application. Nothing in this specification should be construed as an endorsement of disqualification prior to such publications for reasons of prior invention. In addition, the publication dates provided may differ from the actual publication dates that need to be confirmed individually. All publications referred to herein are incorporated herein by reference to disclose and describe in which structure and / or method the publication is cited. The following applications are incorporated herein by reference in their entirety: US Patent Provisional Application No. 61 / 435,250, filed January 21, 2011 ("SYSTEMS AND METHODS FOR SAMPLE". USE MAXIMIZATION "), and US Patent Application No. 2009/0088336 ("MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF"). The following applications are incorporated herein by reference in their entirety: US Patent Application 2005/010937, US Patent 8,380,541; filed February 18, 2013. US Provisional Patent Application No. 61 / 766,113; US Patent Application No. 13 / 769,798 filed on February 18, 2013; US Patent Application No. 13/769 filed on February 18, 2013 , 779; US Patent Application No. 13 / 769,820 filed on February 18, 2013; US Patent Application No. 13 / 244,947 filed on September 26, 2011; September 2012 PCT / US2012 / 57155 filed on 25th; US Patent Application 13 / 244,946 filed on September 26, 2011; US Patent Application 13 / filed on September 26, 2011 244,949; and US Provisional Patent Application No. 61 / 673,245, filed September 26, 2011, the disclosures of these patents or patent applications are incorporated herein by reference in their entirety. Is done. In addition, U.S. Patent Application No. 62 / 195,287 filed on July 21, 2015, U.S. Patent Application No. 62 / 011,023 filed on June 11, 2014, and July 30, 2014. U.S. Patent Application Nos. 14 / 447,099 filed, U.S. Patent Application No. 14 / 446,080 filed July 29, 2014, and U.S. Patent Application filed December 5, 2013. All of Nos. 14 / 098,177 are incorporated herein by reference in their entirety for all purposes.
Embodiment

One embodiment described herein provides a device for collecting a body fluid sample from a subject: the body fluid sample into the device from a single end of the device in contact with the subject. At least two sample collection pathways configured to withdraw, thereby separating the fluid sample into two separate samples; multiple sample containers for receiving the body fluid sample collected in the sample collection pathway. A second portion comprising, the sample container is operably engageable because it is in fluid communication with the sample collection path, and when fluid communication is established, the container is said to be said. It provides the driving force to move most of the two separate samples from the path to the container.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: configured to withdraw a fluid sample therein via a first type of driving force. A first portion containing at least one fluid collection site leading to at least two sample collection pathways; a second portion containing multiple sample containers for receiving fluid samples collected from said sample collection pathway. The container is operably engageable because it is in fluid communication with the sample collection path, and when fluid communication is established, the container traverses most of the two separate samples. A filling measuring instrument that provides a second driving force that is different from the first driving force for moving from the container to the container and that at least one of the sample collection paths indicates when the minimum filling level is reached. Containing, and at least one said sample container may engage with at least one said sample collection path because it is in fluid communication.

Another embodiment described herein provides a device for collecting a fluid sample, including: for drawing a fluid sample into a sample collection channel via a first type of driving force: A first portion comprising at least two sample collection channels configured in, one of the sample collection channels having an internal coating designed to mix with said fluid sample, and another said. The sample collection channel has a separate internal coating that is chemically different from the internal coating; it is the second portion of the sample collection channel that contains multiple sample containers for receiving fluid samples. The sample container is operably engageable because it is in fluid communication with the sample collection path, and when fluid communication is established, the container is large of the two separate samples. A second driving force that is different from the first driving force for moving the portion from the path to the container is provided, and the containers are arranged so that fluid sample mixing does not occur between the containers. ..

In another embodiment described herein, a device for collecting fluid samples is provided: a first portion comprising a plurality of sample collection channels, wherein at least two of the channels. , Each of the at least two sample collection channels is configured to simultaneously withdraw a fluid sample via a first type of driving force; multiple samples for receiving fluid samples collected in the sample collection channel. The second part, including the container, is the first state in which the sample container is not in fluid connection with the sample collection channel, and the sample container is manipulated to allow fluid communication with the collection channel. The container is different from the first driving force in order to move the fluid sample from the channel to the container when fluid communication is established, including a second state that is capable of engaging. It provides the second driving force.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: (a) includes a first opening and a second opening, and said first. A collection channel configured to pull out a body fluid sample by capillary action from the opening of the body to the second opening; and (b) a sample container for receiving the body fluid sample, wherein the container is It is engageable with the collection channel, has a vacuum interior in it, and has a cap configured to receive the channel; the second opening penetrates the cap of the sample container. And defined by a portion of the collection channel configured to provide a flow path of fluid between the collection channel and the sample container, and the sample container is 10 times the internal volume of the collection channel. Has an internal volume of less than.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: (a) includes a first opening and a second opening, and said first. A collection channel configured to pull out a body fluid sample by capillary action from the opening of the body fluid sample; (b) a sample container for receiving the body fluid sample, wherein the container is said to be said. It is engageable with the collection channel, has a vacuum interior in it, and has a cap configured to receive the channel; and (c) the fluid flow path of the collection channel and the sample vessel. An adapter channel configured to provide in between, having a first opening and a second opening, wherein the first opening contacts a second opening of the collection channel. The second opening is configured to penetrate the cap of the sample container.

In another embodiment described herein, a device for collecting a fluid sample is provided: (a) a body comprising a collection channel, wherein the collection channel is the first opening. Containing a portion and a second opening, and configured to withdraw a fluid sample from the first opening towards the second opening by capillary action; (b) to receive the fluid sample. A base containing a sample container of, which is engageable with the collection channel, has a vacuum interior therein, and has a cap configured to receive the channel; and ( c) A support, wherein the sample collecting device is configured to have an stretched state and a compressed state, and in the stretched state of the device, at least a part of the base is closer to the main body than in the compressed state. The body and the base are coupled to the opposite ends of the support and configured to be movable relative to each other so that the second opening of the collection channel is of the sample container. Configured to penetrate the cap, in the extended state of the device, the second opening of the collection channel does not contact the inside of the sample container, and in the compressed state of the device, the first of the collection channel. The second opening extends through the cap of the container and into the inside of the sample container, thereby providing fluid communication between the collection channel and the sample container.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: (a) A body comprising a collection channel, wherein the collection channel is the first opening. Containing a portion and a second opening, and configured to withdraw a body fluid sample by capillary action from the first opening to the second opening; (b) to receive the body fluid sample. A base containing the sample container of, which is engageable with the collection channel, has a vacuum interior therein, and has a cap configured to receive the channel; (c). ) A support, and (d) an adapter channel having a first opening and a second opening, wherein the first opening is to contact a second opening of the collection channel. The second opening is configured to penetrate the cap of the sample container, and the sample collecting device is configured to have an stretched state and a compressed state, and is in a compressed state in the stretched state of the device. The body and the base are coupled to the opposite ends of the support and configured to be movable relative to each other so that at least a portion of the base can be closer to the body than in. In the extended state of the device, the adapter channel is not in contact with one or both of the collection channel and the inside of the sample container, and in the compressed state of the device, the first of the adapter channels. The opening is in contact with the second opening of the collection channel, and the second opening of the adapter channel extends through the cap of the container and into the sample container. Provides fluid communication between the collection channel and the sample container.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: (a) A body that includes a collection channel, wherein the collection channel is the first opening. Containing a portion and a second opening, and configured to pull a fluid sample from the first opening towards the second opening by capillary action; (b) engage the body. A base, the base supporting a sample container, the container being engageable with the collection channel, having a vacuum interior therein, and a cap configured to receive the channel. The second opening of the collection channel is configured to penetrate the cap of the container and extend into the sample container, thereby providing fluid communication between the collection channel and the sample container. Will be done.

In another embodiment described herein, an apparatus is provided that includes the following for collecting body fluid samples: (a) A body comprising a collection channel, wherein the collection channel is the first opening. Containing a portion and a second opening, and configured to pull a fluid sample from the first opening towards the second opening by capillary action; (b) engage the body. A base, the base supporting a sample container, the container being engageable with the collection channel, having a vacuum interior therein, and having a cap configured to receive the channel. (C) An adapter channel having a first opening and a second opening, wherein the first opening is configured to contact a second opening of the collection channel, and The second opening is configured to penetrate the cap of the sample container.

It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. As a non-limiting example, the body may include two collection channels. Optionally, the interior of the collection channel is coated with an anticoagulant. Optionally, the body is coated with a first and second collection channel, and the interior of the first collection channel is coated with a different anticoagulant than the interior of the second collection channel. .. Optionally, the first anticoagulant is ethylenediaminetetraacetic acid (EDTA), and the second anticoagulant is different from EDTA. Optionally, the first anticoagulant is citrate, and the second anticoagulant is different from citrate. Optionally, the first anticoagulant is heparin, and the second anticoagulant is different from heparin. Optionally, one anticoagulant is heparin, and the second anticoagulant is EDTA. Optionally, one anticoagulant is heparin, and the second anticoagulant is citrate. Optionally, one anticoagulant is citrate, and the second anticoagulant is EDTA. Optionally, the body is formed from an optically permeable material. Optionally, the instrument includes as many sample containers as the collection channel. Optionally, the instrument includes as many adapter channels as the collection channel. Optionally, the base includes an optical measuring instrument that provides a visual indication of how the sample has reached the sample container in the base. Optionally, the base is a window through which the user can see the container within the base. Optionally, the engaging assembly exerts a force so that the support includes a spring and the device can be in an extended state when in its natural state. Optionally, the second opening of the collection channel or adapter channel is capped by a sleeve, which is mediated by capillary action from the first opening to the second opening. Does not prevent the movement of body fluids. Optionally, the sleeve includes a vent. Optionally, each collection channel can hold a volume of as much as 500 μL. Optionally, each collection channel can hold a volume of as much as 200 μL. Optionally, each collection channel can hold a volume of as much as 100 μL. Optionally, each collection channel can hold a volume of as much as 70 μL. Optionally, each collection channel can hold a volume of as much as 500 μL. Optionally, each collection channel can hold a volume of as much as 30 μL. Optionally, the length of the inner circumference of the cross section of the collection channel is about 16 mm. Optionally, the length of the inner circumference of the cross section of the collection channel is about 8 mm. Optionally, the length of the inner circumference of the cross section of the collection channel is about 4 mm. Optionally, the length of the internal circumference is the circumference. Optionally, the device comprises first and second collection channels, and the first channel opening is adjacent to the second channel opening, and the opening is simply blood. It is configured to draw blood from a single drop at the same time. Optionally, the opening of the first channel and the opening of the second channel have a center-to-center spacing of about 5 mm or less. Optionally, each sample vessel has an internal volume of less than 20 times the internal volume of the collection channel that is engageable. Optionally, each sample container has an internal volume that is less than 10 times the internal volume of the collection channel that is engageable. Optionally, each sample container has an internal volume that is less than 10 times the internal volume of the collection channel that is engageable. Optionally, each sample vessel has an internal volume that is less than five times the internal volume of the collection channel that is engageable. Optionally, establishing fluid communication between the collection channel and the sample vessel results in the transfer of at least 90% of the fluid sample in the collection channel into the sample vessel.

It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, establishing fluid communication between the collection channel and the sample vessel results in the transfer of at least 90% of the fluid sample in the collection channel into the sample vessel. Optionally, establishing fluid communication between the collection channel and the sample vessel results in the transfer of at least 98% of the fluid sample in the collection channel into the sample vessel. Optionally, establishing fluid communication between the collection channel and the sample container results in the movement of the body fluid sample in the collection channel into the sample container, and about 10 μL of the body fluid sample is transferred to the collection channel. Brings to remain in. Optionally, establishing fluid communication between the collection channel and the sample vessel results in the movement of the fluid sample in the collection channel into the sample vessel, and about 5 μL of the fluid sample is the collection channel. Brings to remain in. Optionally, establishing fluid communication between the collection channel and the sample vessel results in the movement of the fluid sample in the collection channel into the sample vessel, and about 2 μL of the fluid sample is the collection channel. Brings to remain in.

In another embodiment described herein, a method is provided: the sample is withdrawn into at least two collection channels of the sample collection device by means of the first type of driving force. By contacting one end of the sample collection device with the body fluid sample to divide the sample into at least two parts; making sure that the desired amount of sample fluid is in at least one collection channel. After that, establishing fluid communication between the sample collection channel and the sample container, wherein the container is the first driving force to move each of the body fluid sample portions into their respective containers. Provides a second driving force that is different from.

In another embodiment described herein, a method is provided: to simultaneously draw a fluid sample into at least two sample collection channels, respectively, via a first type of driving force: Using a configured sample collection instrument with at least two sample collection channels, a minimum amount of sample is dispensed into at least two said channels; the desired amount of sample fluid is at least one said collection. To establish fluid communication between the sample collection channel and the sample container after confirming that it is in the channel, because the container moves each of the body fluid sample portions into their respective containers. Provides a second driving force that is different from the first driving force used for collecting.

In another embodiment described herein, a device for collecting a body fluid sample is provided: (a) a device comprising a collection channel, wherein the collection channel is the first opening. And through the second opening from the first opening and through the second opening so that the fluid sample can fill the collection channel. Contacting the body fluid sample with a device configured to withdraw the body fluid sample by capillary action towards the second opening; (b) a fluid flow path between the collection channel and the interior of the sample container. The sample container has an internal volume of less than 10 times the internal volume of the collection channel, and the establishment of a fluid flow path between the collection channel and the inside of the sample container is described as described above. Negative pressure is generated at the second opening of the collection channel, and inside the collection channel and the sample container so that the fluid sample can be moved from the collection channel into the sample container. There is a vacuum before the fluid flow path between them is established.

In another embodiment described herein, a device is provided that includes the following for collecting body fluid samples: (a) at least one of the collection channels in the device from the first opening to the second. The fluid sample is brought into contact with any of the collection devices described herein so that the fluid sample can fill the collection channel through the opening of; and (b) the collection channel and the sample. The collection so that the establishment of the fluid flow path inside the container creates a negative pressure at the second opening of the collection channel and the fluid sample is moved from the collection channel into the sample container. Establish a fluid flow path between the channel and the interior of the sample vessel.

It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, the collection channel and the inside of the sample vessel are not brought into fluid communication until the fluid reaches the second opening of the collection channel. Optionally, the device comprises two collection channels, and the collection channel and the inside of the sample vessel are not brought into fluid communication until the fluid reaches the second opening of both collection channels. .. Optionally, a second opening of the collection channel in the instrument is configured to penetrate the cap of the sample container and fluid between the second opening of the collection channel and the sample container. The sex flow path provides relative movement between the second opening of the collection channel and the sample container such that the second opening of the collection channel penetrates the cap of the sample container. Established by. Optionally, the device has an adapter channel for each collection channel of the device, the adapter channel having a first opening and a second opening, said first opening. Is configured to contact the second opening of the collection channel, and the second opening is configured to contact the cap of the sample container, and between the collection channel and the sample container. The fluid flow path of the two or more such that the second opening of the adapter channel penetrates the cap of the sample container: (a) the second opening of the collection channel, (b) said. Established by providing an adapter channel, and (c) relative movement between said sample vessels.

In another embodiment described herein, a device for collecting a fluid sample from a subject is provided: (a) a device comprising a first channel and a second channel, said subject. Each channel has an inflow opening configured for fluid communication with the body fluid, and each channel is an inlet opening of each channel. It has an outflow opening downstream of, and each channel is configured to withdraw fluid from the inflow opening towards the outflow opening via capillary action; (b) the first channel and Bringing the first channel and the second channel into fluid communication with the first container and the second container, respectively, through the outflow opening of each of the second channels; and ( c) Directing the fluid in each of the first channel and the second channel to each of the first container and the second container with the assistance of (i) or (ii) below. : (I) Negative pressure with respect to atmospheric pressure in the first container or the negative pressure of the second container, in which the body fluid passes through the first channel or the second channel. Sufficient to flow into the corresponding container, or (ii) a positive pressure on atmospheric pressure in the first channel or the second channel, wherein the positive pressure the body fluid is the first channel. Alternatively, it is sufficient to flow through the second channel into the corresponding container.

Another embodiment described herein provides a method of manufacturing a sample collection device, including: fluid through each of at least two sample collection channels, via a first type of driving force. Forming one portion of a sample collection device with at least two channels configured to withdraw samples simultaneously; forming a sample container, moving a fluid sample from said channel into said container. The container is configured to connect with the sample collection device to provide a second motive force that is different from the first motive force used to collect the sample.

Another embodiment described herein provides instructions performed by a computer to perform a method that includes: within each of at least two sample collection channels, the first type. Forming one part of a sample collection device with at least two channels configured to simultaneously draw a fluid sample through its motive force.

In another embodiment described herein, instructions are provided that are performed by a computer to perform a method that includes: forming a sample container, from said channel into said container. The container is configured to connect with the sample collection device to provide a second motive force that is different from the first motive force used to collect the sample to move the body fluid sample to. ..

Yet another embodiment described herein provides a device for collecting a body fluid sample from a subject: the body fluid sample from a single end of the device in contact with the subject. Means for drawing into the instrument and thereby separating the fluid sample into two separate samples; means for moving the fluid sample into multiple sample containers, wherein the container is the two separate samples. Most of them provide the driving force to move from the path into the container.

The above is a complete description of the preferred embodiments of the invention, but various alternatives, modifications and equivalents can be used. Therefore, the scope of the present invention should not be determined with reference to the above description, but with reference to the appended claims and the full scope of their equivalents. Any feature, whether suitable or not, can be combined with other features, whether suitable or not. Unless the prescribed claims are explicitly stated using the phrase "means for," the attached claims are not construed to include the limitation of means plus functionality. As used throughout the description of the specification, the claims below, "a (1)", "an (1)" and "the (above)" are unless expressly indicated in the context. It should be understood that it has multiple meanings. Moreover, as used throughout the description of this specification and the claims below, the meaning of "in" is "in" unless the context explicitly indicates it. , And "on (on top of)". Finally, in addition, the meanings of "and (and)" and "or (or)" as used throughout the description of this specification and the claims below are conjunctions unless explicitly stated in the context. And can be used interchangeably, including liaison conjunctions. Therefore, unless explicitly stated in the context, when the terms "and (and)" or "or (or)" are used in the context, the usage of such a connection is "and / or (and)". / Or) ”is not excluded. The following US patent applications are incorporated herein by reference for all purposes: No. 61 / 733,886, filed December 5, 2012, No. 61, filed September 7, 2013. / 875,030, and 61 / 875,107 filed on September 8, 2013. This document contains material that is subject to copyright protection. For example, all figures shown herein are copyrighted. Copyright holders (patent applicants herein) do not object to reproductions of patent documents and disclosures, as they appear in US Patent and Trademark Office patent files or records, regardless of what they are otherwise. , All rights reserved. The following notes apply: Copyright 2013 Terranos

Claims (1)

Systems, equipment, methods, etc.

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