CN104968269A

CN104968269A - Systems, devices, and methods for bodily fluid sample collection and transport

Info

Publication number: CN104968269A
Application number: CN201380072120.6A
Authority: CN
Inventors: E·A·霍姆斯; C·卢; M·陈; D·杨
Original assignee: Theranos Inc
Current assignee: Serranos Intellectual Property LLC
Priority date: 2012-12-05
Filing date: 2013-12-05
Publication date: 2015-10-07
Anticipated expiration: 2033-12-05
Also published as: JP2016505302A; AU2018220026A1; MX2015007134A; JP2019205911A; CN109730697A; BR112015012944A2; KR20150092265A; CN104968269B; CA2891513A1; IL239062A0; HK1215848A1; JP2021178210A; WO2014088606A2; AU2013356680A1; WO2014088606A8; SG11201504233RA; WO2014088606A3

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.

Description

Systems, devices and methods for bodily fluid sample collection, transport and handling

Background

Blood samples for laboratory testing are typically obtained by means of venipuncture, which typically involves the insertion of a hypodermic needle into a vein of a subject. Blood drawn by the hypodermic needle may be drawn directly into the syringe or into one or more sealed vials for subsequent processing. When venipuncture may be difficult or impractical, such as on a newborn infant, a non-venipuncture such as a heel puncture or other alternate site puncture may be used to draw a blood sample for testing. After the blood sample is collected, the extracted sample is typically packaged and transferred to a processing center for analysis.

Unfortunately, conventional sample collection and detection techniques for bodily fluid samples have drawbacks. For example, in addition to the most basic tests, currently available blood tests typically require the withdrawal of a substantial volume of blood from a subject. Due to the large volume of blood, drawing blood from an alternate sampling site on the subject (which may be less painful and/or less invasive) is often disadvantageous because it does not yield the volume of blood required for conventional detection methods. In some cases, patient apprehension associated with venipuncture may reduce patient compliance with the detection protocol. Furthermore, it can be problematic to transport small volumes of sample fluid while still maintaining sample integrity.

Disclosure of Invention

At least some or all of the embodiments described in this disclosure overcome at least some of the disadvantages associated with the prior art. While embodiments herein are generally described in the context of obtaining a fluid sample (such as, but not limited to, a blood sample), it should be understood that embodiments herein are not limited to a blood sample, and may also be adapted to collect one or more other fluids or one or more body samples for analysis.

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

In one non-limiting example, the device may be used to directly separate the bodily fluid sample into two or more distinct portions, which are then deposited into their respective sample vessels. In one non-limiting example, the device includes a first portion having at least two sample collection channels configured to draw a fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an internal coating designed to mix with a fluid sample and another of the sample collection channels has another internal coating that is chemically different from the internal coating. The sample collection device includes a second portion including a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels being operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the sample vessels. The sample vessels may be arranged such that no mixing of the fluid sample between the vessels occurs. The device may be used to collect blood or other bodily fluids. Collecting blood from a vein may be relatively fast; however, non-venous blood draws can take a long period of time to obtain a desired volume of sample, and early introduction of materials, such as anticoagulants, that can coat the channels can prevent premature clogging of the channels during collection.

In another embodiment described herein, a device for collecting a bodily fluid sample is provided. The device comprises a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force. The device may further comprise a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, wherein the sample vessels have a first condition in which the sample vessels are not in fluid communication with the sample collection channel and a second condition in which the sample vessels may be operably engaged to be in fluid communication with the collection channel, whereupon when fluid communication is established, the sample vessels provide a second motive force different from the first motive force to move the bodily fluid sample from the channel into the sample vessels. In embodiments, the motive force to move the bodily fluid may include a motive force derived from capillary action, reduced pressure (e.g., a vacuum or partial vacuum that draws fluid into a location having reduced pressure), increased pressure (e.g., to force fluid out of a location having increased pressure), wicking material, or other means.

In a further embodiment described herein, a method is provided that includes metering a minimum amount of sample into at least two channels by using a sample collection device having at least two of the sample collection channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force. After a desired amount of sample fluid has been confirmed to be in the collection channel, fluid communication is established between the sample collection channel and the sample vessel, whereupon the vessel provides a second motive force different from the first motive force to collect the sample to move the bodily fluid sample from the channel into the vessel. In some alternative embodiments, devices that use only a single channel to collect the bodily fluid or devices that have multiple channels but do not simultaneously collect bodily fluid are not excluded. Optionally, the collection of the sample fluid is performed without the use of a wicking material.

In one embodiment, there is a discrete amount of time between sample collection and introduction of the sample into the sample pre-treatment device. In one non-limiting example, the process is a non-continuous process. The sample collection occurs at one processing station and then the sample is brought to a second station. The second station may be in a sample building. Alternatively, the second station may be located at another location, where the sample needs to be walked, driven, air-transported, placed in a transport device, or placed in a transport container to reach the second location. In this way, there are discrete pauses in the process to allow time associated with sample transport.

In another embodiment herein, one or more separation gels may also be included in the sample vessel such that the gel will separate the cell-free portion of the whole blood from the cellular or other solid or semi-solid portion of the sample. Such a gel or other similar separation material may be contained in the sample vessel before, during or after introduction of the sample into the sample vessel. The separation material may have a density between that of the cells and the solution components, such that the material separates the sample components by flowing to a location between the solution sample layer and the non-solution sample layer during separation (such as by centrifugation). After centrifugation, the separation material stops flowing and remains as a soft barrier between the layers. In some embodiments, the separation material may be further treated to harden it into a more rigid barrier. In one non-limiting example, the separation material may be a UV curable material such as, but not limited to, a thixotropic gel of sorbitol-based gelling agent in diacrylate oligomers. The sample vessel may expose the entire vessel, or alternatively the portion with the UV curable material, to UV light for a period of time such as, but not limited to, 10 to 30 seconds to harden the material. Such hardening may involve cross-linking of materials in the UV curable material. Alternatively, the UV curable material may be used in combination with a conventional separation gel material such that only one side (solution side or solid side) is in contact with the UV curable material. Optionally, the UV curable material may be used with a third material such that the UV curable material is located between two separate materials and is not in direct contact with the solution and non-solution portions of the sample.

A bodily fluid sample can be collected by the devices disclosed and described herein. Methods of using these devices to collect bodily fluids are disclosed and described herein. A bodily fluid sample, such as a sample that has been 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.

In at least one embodiment described herein, a method for physically transporting a small volume of bodily fluid in liquid form from one location to another is provided. By way of non-limiting example, the sample is collected at the collection site in liquid form, transported in liquid form, and arrived at the analysis site in liquid form. In many embodiments, the liquid form during transport does not remain in the porous matrix, wicking material, fabric (webbing), or similar material that would prevent extraction of the sample in the liquid form at the target site. In one embodiment, the small volume of sample in each sample vessel is in the range of about 1ml to about 500 microliters. Optionally, the small volume is in the range of about 500 microliters to about 250 microliters. Optionally, the small volume is in the range of 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 is in the range of 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.

As disclosed and described herein, a transport container may include components configured to receive and retain a sample vessel. In embodiments, an assembly configured to receive and retain a sample vessel may be configured to receive and retain a plurality of sample vessels. In an embodiment, such a component may comprise a flat plate, such as a tray. In embodiments, such an assembly (e.g., a plate) may include an opening (e.g., a slot, well, or receptacle) having an inner surface configured to accept a sample vessel. In an embodiment, a transport container may include an assembly including a plurality of openings (e.g., slots, wells, or receptacles) each having an inner surface configured to accept a sample vessel. In embodiments, such an inner surface may be at least partially substantially complementary to the outer surface of the sample vessel or a portion thereof.

In another embodiment described herein, the shipping container may provide a high density per unit area of sample vessels that are held in a fixed manner during shipping but are removable at the target location. In one non-limiting example, the sample vessels are positioned in an array, wherein there are at least six sample vessels per square inch when the array is viewed from top to bottom. Optionally, there are at least eight sample vessels per square inch when the array is viewed from top to bottom. Optionally, there are at least ten sample vessels per square inch when the array is viewed from top to bottom. Any conventional technique for shipping multiple samples typically uses a bale, with the sample vessels in the bale in a loose, unconstrained form. In some embodiments, the transport container may accommodate certain sample vessels, such as those from the same subject, in closer proximity relative to a horizontal or other spaced-apart adjacent sample vessel so that they may be visually identified as being from a common subject. Optionally, the transport container has an opening to receive a carrier that holds one or more sample vessels together, where those vessels have in common, such as but not limited to from the same subject.

In embodiments, the sample vessel is adapted to assist in holding the sample in liquid form. In an embodiment, the sample is treated before it reaches the sample vessel in a manner suitable for holding the sample in liquid form. For example, the sample vessel may include an anti-clotting agent, or the sample may be treated with an anti-clotting agent prior to or during transport to the sample vessel. In embodiments, the anti-clotting agent may be selected from heparin (e.g., lithium or sodium heparin), ethylenediaminetetraacetic acid, 4-hydroxycoumarin, Vitamin K Antagonist (VKA) anticoagulant, or other additive. In addition to high density per unit area, some embodiments of the shipping container also contain high density samples, including those from a plurality of different subjects. By way of non-limiting example, the transport container may have four samples from one subject, two samples from another subject, etc., until most or all of the available openings in the transport container are filled.

It should be understood that each sample may be sent to a selected assay individually and, at least in one embodiment, not grouped in the transport container based on the assay to be performed. By way of non-limiting example, not all samples in a transport container are collected for the same assay. Conventional test systems may group together samples that are destined for the exact same test for shipping only. In at least one embodiment herein, there is a plurality of samples, each sample designated to receive its own set of tests. In such embodiments, the grouping in the transport container is not limited to only those samples that are targeted for the same assay. This may further simplify sample handling since there is no need to further separate sample transport based on the tests to be performed. Some embodiments of the transport container comprise samples from at least three or more different patients. Some embodiments of the transport container comprise samples from at least five or more different patients. Some embodiments of the transport container comprise samples from at least ten or more different patients. Some embodiments of the transport container comprise samples from at least twenty or more different patients.

By way of non-limiting example, one embodiment described herein may optionally use one or more trays having slots for receiving the sample vessels and/or sample vessel holders. In one embodiment, the tray may double as a containment device during storage in a cooling chamber while awaiting more samples or transport, and in one embodiment, the tray itself may also be cleaned and sterilized, as in some embodiments, the tray may be removed from the transport container. In some embodiments, the tray in the shipping container may be held parallel to the cover of the shipping container. Optionally, the tray may be held inside the shipping container at an angle to the cover of the shipping container. Optionally, the tray is non-removably secured to the shipping container. Optionally, the tray is integrally formed with the shipping container itself. Alternatively, a plurality of trays having the same or different sizes or configurations may be placed inside the shipping container.

In yet another embodiment described herein, a method is provided for transporting small volume sample vessels using a transport container having an integrated thermal control unit and/or materials that provide active and/or passive cooling. In one embodiment, the thermal control material may be, but is not limited to, an embedded Phase Change Material (PCM) that maintains a temperature at a previous or desired temperature. By way of non-limiting example, the phase change material may resist temperature changes around a critical temperature at which the material undergoes a phase change. If the PCM is embedded, the vessel and passive cooling element may be one and the same. Alternatively, the transport container may use an active cooling system. Optionally, the transport container may use an active cooling system to maintain and/or extend the cooling time associated with the passive cooling assembly. In embodiments, the transport container may comprise a material having a high heat capacity (i.e., a high heat capacity compared to a material such as plastic or polymeric material), and may comprise a large amount of such a high heat capacity material that is effective to maintain at least a portion of the transport container at or near a desired temperature for an extended period of time.

Optionally, the method comprises a single step for transferring a plurality of sample vessels from different subjects from the temperature controlled storage area into the transport container. By way of non-limiting example, the single step may simultaneously transfer twenty-four or more sample vessels from a storage location to a fixed location in the transport container. Alternatively, the single step may simultaneously transfer thirty-six or more sample vessels from a storage location to a fixed location in the transport container. Alternatively, the single step may simultaneously transfer forty-eight or more sample vessels from a storage location to a fixed location in the transport container. In such embodiments, the tray may initially be in a heat-controlled environment, such as, but not limited to, a freezer, wherein samples from individual subjects are collected over time until a desired number is reached. In one such embodiment, the tray in the transport container that holds the one or more sample vessels is the same tray that holds the sample vessels in the storage area. Alternatively, the tray may be identical to a storage holder for containing a sample prior to loading the sample into the transport container. Since the same tray that holds the sample vessels will be used in the transport container, the risk of losing samples during this transfer, missing samples in an unregulated thermal environment, etc. is reduced. Because substantially all of the sample vessels in the tray are accumulated in the heat control storage area and then transferred in a single step, the samples all undergo substantially the same thermal exposure while being transferred from the heat control storage area into the transport container. Because the sample vessels experienced substantially the same exposure, sample-to-sample variability was reduced due to different exposure times.

Optionally, the method comprises using an individually addressable sample vessel configuration. Optionally, groups of sample vessels, such as those in a common carrier, may be addressed in predefined groups. Alternatively, even the sample vessels in the common carrier may be individually addressable. Although this is not a requirement for all embodiments herein, it is particularly useful when loading and/or unloading samples, sample vessels and/or sample holders from the tray.

Some embodiments may use a further container ("outer box") external to the transport container to provide further physical and/or thermal control capabilities. One or more of the shipping containers may be placed within the outer box and the combination may be transported from one location to a destination location. By way of non-limiting example, this may be in the form of a corrugated plastic outer box, wherein the outer box is configured to at least partially encase or surround a shipping container. In an embodiment, the outer box provides thermal insulation for the transport container enclosed therein. Some embodiments may use a closed cell extruded polystyrene foam outer box. Some embodiments of the outer carton may be formed from thermoformed sheets. In some embodiments, the outer box can have grips, handles, pads, wheels, latches, tie rods, and/or other features for holding, manipulating, securing, protecting, transporting, or otherwise controlling the position, orientation, and/or access of the contents of the outer box. Some embodiments of the outer box may have their own active and/or passive thermal control units. In embodiments, the outer box provides cooling and thermal insulation for the one or more transport containers enclosed therein. One or more embodiments of the outer carton may be configured to receive one or more shipping containers. Optionally, the vessel may also provide additional thermal control to the transport vessels by providing a thermally conditioned environment between desired temperature ranges to one or more of the transport vessels. Optionally, the temperature range is between about 1 ℃ to 10 ℃, optionally between 2 ℃ to 8 ℃ or between 2 ℃ to 6 ℃.

In yet another embodiment described herein, a method for thermally characterizing a transport container after a number of cooling cycles is provided. By way of non-limiting example, after a certain number of cycles, the transport container may be thermally characterized to ensure that the container continues to perform operations within a desired range.

Some embodiments of the container and/or tray may include a thermal change indicator. In one non-limiting example, the indicator is integrated on the visible surface of the shipping container, tray, and/or on the outer carton. In one non-limiting example, thermochromic inks can be used as indicators of thermal changes, particularly if the thermal changes result in temperatures outside a desired range. In one embodiment, the indicator may be configured to color change the entire bin and/or tray. The change may be reversible or irreversible. Optionally, the indicator is positioned on only selected portions of the shipping container and/or tray, not the entire container or tray.

In one embodiment described herein, a method is provided that includes collecting a bodily fluid sample at a surface of a subject, wherein the collected sample is stored in one or more sample vessels; providing a transport container to house at least two or more sample vessels in a first orientation; and arranging for the sample vessels to be transported in the transport container from a first location to a second location, wherein each sample vessel reaches the second location and contains a majority of its bodily fluid sample in a non-wicking, non-matrix form that can be removed from the sample vessel in liquid form, and wherein the amount of sample in each sample vessel does not exceed about 2 ml. In embodiments, the amount of sample in each sample vessel is no more than about 1ml, or no more than about 500 μ L, or no more than about 250 μ L, or no more than about 100 μ L, or no more than about 50 μ L or less.

In another embodiment described herein, there is provided a method for shipping a plurality of sample vessels, the method comprising: providing a container configured to receive at least five or more sample vessels each containing capillary blood; and arranging for the sample vessels to be transported in the transport container from a first location to a second location, wherein each sample vessel reaches the second location and contains a majority of its capillary blood in liquid, non-wicked form that can be removed from the sample vessel for further processing, and wherein the amount of capillary blood in each sample vessel does not exceed about 2 ml. In embodiments, the amount of capillary blood in each sample vessel is no more than about 1ml, or no more than about 500 μ L, or no more than about 250 μ L, or no more than about 100 μ L, or no more than about 50 μ L or less.

In another embodiment described herein, there is provided a method for shipping a plurality of sample vessels for containing a biological sample, the method comprising: providing a container configured to hold at least five or more of the sample vessels, wherein the amount of sample in each sample vessel is no more than about 2 ml; and transporting the containers and sample vessels from the first location to a second location, wherein each sample vessel arrives at the second location and contains a majority of its biological sample in liquid, non-wicked form, which can be removed from the sample vessel for further processing. In embodiments, the amount of sample in each sample vessel is no more than about 1ml, or no more than about 500 μ L, or no more than about 250 μ L, or no more than about 100 μ L, or no more than about 50 μ L or less.

In another embodiment described herein, there is provided a method for transporting a plurality of sample vessels containing capillary blood, the method comprising: providing a container having a thermally regulated interior region configured for receiving at least five or more sample vessels in a controlled configuration such that at least one cooling surface of the container faces the sample vessels and transmits a controlled release of thermal cooling according to a temperature profile that maintains the interior region at about 1 to 10 ℃ during transport without freezing the blood sample; and transporting the containers from the first location to the second location, wherein each sample vessel reaches and contains a majority of its liquid, non-wicked form of capillary blood that may be removed from the sample vessel for further processing.

In another embodiment described herein, a method is provided for shipping a plurality of blood sample vessels, the method comprising shipping a container having a thermally controlled interior configured to receive 10 or more sample vessels in an array configuration, wherein each vessel holds a majority of its free-flowing, non-wicked form of blood sample, and wherein about 1ml or less of blood is present in each vessel, and each vessel has an interior with an at least partially vacuum atmosphere; wherein sample vessels are held in an array configuration to position the sample vessels at a controlled distance and orientation from a cooling surface, wherein there is at least one preferential thermal pathway from the surface to the sample vessels.

In another embodiment described herein, there is provided a method for shipping a plurality of sample vessels of less than 1ml, the method comprising mixing a sample with an anticoagulant prior to transferring the sample to each sample vessel; associating each sample vessel with a subject and a set of required sample tests; and transporting a thermal control container housing the plurality of lower than 1ml sample vessels in an array configuration, wherein each vessel contains a majority of its free-flowing, non-wicked form of the sample, wherein the vessels are arranged such that there are at least two vessels in each container associated with each subject, wherein at least a first sample comprises a first anticoagulant and a second sample comprises a second anticoagulant in a matrix.

In another embodiment described herein, there is provided a method comprising: a) placing the plurality of sample vessels in a temperature-controlled transport container comprising a controlled uniform heat distribution, high heat fusion material configured to be in thermal communication with the sample vessels, wherein the material does not cause freezing of a sample fluid in the sample vessels; b) placing the heat distribution transport container in a product cavity defined by at least a top wall and a bottom wall of the transport container; c) placing an active cooling device in thermal communication with the cavity, whereby the cooling device is adapted to cool the cavity when activated, the sorption cooling device comprising an absorber positioned such that heat generated in the absorber is dissipated outside the product cavity; d) activating the cooling device to begin cooling of the cavity; e) transporting the transport container from a first location to a second location; and f) removing the product from the chamber.

In another embodiment described herein, there is provided a method of shipping a plurality of sample vessels of less than 1ml, the method comprising: transporting a thermal control container housing the plurality of lower than 1ml sample vessels in an array configuration, wherein each vessel contains a majority of its free-flowing, non-wicked form of the sample, and wherein the vessels are arranged such that there are at least two vessels in each container associated with each subject, wherein at least a first sample comprises a first anticoagulant and a second sample comprises a second anticoagulant in a matrix.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. In one non-limiting example, the bodily fluid sample is blood. Optionally, the bodily fluid sample is capillary blood. Optionally, collecting the bodily fluid sample comprises performing at least one puncture on the subject to release bodily fluid, wherein the puncture is not a venipuncture. Optionally, collecting comprises using at least one microneedle to make at least one puncture in the subject. Optionally, collecting comprises making at least one puncture of the subject using at least one lancet. Optionally, the puncture is formed by a finger puncture. Optionally, the puncture is formed by pricking skin on the forearm of the subject. Optionally, the puncture is formed by pricking skin on the limb of the subject. Optionally, the surface is the skin of the subject. Optionally, the transport container has an interior, the interior initially being at a sub-atmospheric pressure. Optionally, the sub-atmospheric pressure is at least a partial vacuum. Optionally, the interior of the transport container is at a sub-atmospheric pressure, the sub-atmospheric pressure being at least at a pressure below ambient pressure. Optionally, the sub-atmospheric pressure is selected to provide sufficient force to draw a desired volume of sample into the sample vessel. Optionally, the transport container comprises at least five or more sample vessels. Optionally, the transport container carries bodily fluid samples from a plurality of different subjects. Optionally, the information associated with each sample vessel determines which tests are to be performed on the bodily fluid sample therein. Optionally, the transport container is placed within another container during shipping. Optionally, the method further comprises pre-treating the sample in the sample vessel prior to transport to the second location.

Optionally, the shipping container has a sample vessel array density of at least about 4 vessels per square inch. Optionally, a cooling surface in the transport container provides a temperature profile within a desired range for a sample vessel in the vessels. Optionally, the sample vessels are individually addressable. Optionally, the method further comprises using a cooling tray to contain sample vessels in a cooling chamber prior to loading the vessels into the container and using the same tray to contain sample vessels in the vessels, wherein the samples are placed in the container with the cooling tray. Optionally, the sample vessels are arranged such that there are at least two vessels in each container having a bodily fluid sample from the same subject, wherein at least a first sample comprises a first anticoagulant and a second sample comprises a second anticoagulant in a matrix. Optionally, the fluid sample comprises capillary blood for testing by FDA-approved or FDA-certified assay devices and procedures, or testing by CLIA-certified laboratories. Optionally, the fluid sample comprises blood for testing by FDA-approved or FDA-certified assay devices and procedures, or testing by CLIA-certified laboratories. Optionally, the enclosure of the fused material providing controlled heat distribution and high heat provides at least one cooling surface facing the vessel. Optionally, a high heat fusion material is embedded in the material used to form the vessel. Optionally, the controlled heat distribution, high heat fusion material comprises about 30% to 50%. Optionally, the controlled heat distribution, high heat fusion material comprises about 10% to 30%. Optionally, the method further comprises an outer shell of a metallic material having a resting temperature (resting temperature) below ambient temperature.

Optionally, the method further comprises scanning the information storage unit on each sample at the receiving site and automatically placing the vessel in a cartridge, optionally, the method further comprises containing a sample vessel in the array configuration using the same tray while the sample vessel is in the refrigeration device prior to transport and in the transport container during transport. Optionally, the method further comprises using a tray for containing sample vessels comprising a highly thermally conductive material. Optionally, the tray comprises a plurality of slots having a shape to hold the sample vessel holders in a preferred orientation. Optionally, the tray is configured to directly engage a sample vessel holder. Optionally, a tray locking mechanism is used to retain the tray within the vessel, wherein the tray locking mechanism releases the tray only upon application of a magnetic force. Optionally, the method comprises maintaining the temperature in the range of 2 ℃ to 8 ℃ during transportation. Optionally, the method further comprises a temperature control material that remains above freezing during transport but is about 10 ℃ or less. Optionally, the method comprises using a temperature threshold detection detector to indicate whether the sample vessel reaches a temperature outside a threshold level. Optionally, the method further comprises: scanning vessels in the tray prior to shipment to determine whether a processing step has been performed on the sample; the steps are performed or re-performed using a processor. Optionally, the method further comprises a single step of loading the one or more sample vessels into the tray and a single step of loading the tray into the transport container.

Optionally, the transport container has a first surface configured to define a thermally conductive pathway to a controlled heat distribution, high heat fusion material in the transport container. Optionally, the first surface is configured to be in direct contact with another surface cooled by an adsorption cooling device. Optionally, the method comprises simultaneously bar code scanning sample vessels in the tray. Optionally, the method comprises simultaneously scanning the bottom surfaces of the sample vessels in the tray for bar codes. Optionally, the method comprises bar code scanning the array of sample vessels. Optionally, the method comprises bar code scanning the bottom surface of the array of sample vessels. Optionally, the method comprises reverse transporting the plurality of sample vessels. Optionally, the method comprises transporting a plurality of sample vessels, wherein blood cells and plasma are separated by a barrier material in the sample vessels. Optionally, the method comprises opening the transport container by unlocking and opening the container, wherein at least one hinge holds the two parts together. Optionally, the tray has at least one magnetic contact point for removing the tray from the vessel. Optionally, a computer controlled end effector is used to load and/or unload sample vessels from the transport container, wherein before, during or after unloading, the reader obtains information from at least one information storage unit attached to one or more sample vessels. It will be appreciated that although the shipping container is typically used for shipping, it may also be used as a storage container for the trays and/or sample vessels when the shipping container is not being used for shipping. Thus, the use of the container is not limited to transportation and does not exclude other suitable uses for any of the embodiments.

In yet another embodiment herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: a container having at least a top wall, a bottom wall, and side walls that collectively define a cavity, wherein at least one of the top wall, bottom wall, and side walls contains a phase change material; a frame sized to fit within the cavity and defining an opening configured to receive a plurality of sample vessels and having sidewalls configured to contact the sidewalls of the sample vessels, wherein the vessels are arranged such that each patient has at least a first sample comprising a first anticoagulant and a second sample having a second anticoagulant in a matrix.

In another embodiment described herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: a) a bottom container portion comprising a bottom wall and at least a first sidewall defining a cavity adapted to contain a product therein; b) a top container portion comprising a top surface and a ground surface and adapted to join the bottom container portion to define a product cavity, the top container portion forming a top wall for the vessel; wherein at least one of the top wall, bottom wall and side walls comprises a phase change material.

In another embodiment described herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: a) a bottom container portion comprising a bottom wall and at least a first sidewall defining a cavity adapted to contain a product therein; b) a top container portion comprising a top surface and a bottom surface and adapted to combine with the bottom container portion to define a product cavity, the top container portion forming a top wall of the vessel; c) a holder for defining a plurality of sample vessel receiving spaces to position the sample vessels in a predetermined orientation; wherein at least one of the top wall, bottom wall and side walls comprises a phase change material.

In another embodiment described herein, there is provided a transport container for shipping sample vessels, the container comprising: a generally rectangular base plate; generally parallel sides projecting from the longitudinal edges of the base plate; generally parallel ends projecting from the end edges of the base panel and bridging the sides; a cover fittable over the sides and ends and forming a generally enclosed space with the sides and ends and with the floor; a sample vessel holder removably coupled to a floor in the container interior and configured to define a vessel receiving space. Optionally, the vessel receiving space is configured to receive an evacuated blood collection tube having an internal volume of about 2ml or less. In at least one embodiment, the vessel receiving space is configured to receive a vessel, such as, but not limited to, a vacuum collection tube having an internal volume of about 1ml, or less than about 500 μ L, or less than about 250 μ L, or less than about 100 μ L, or less than about 50 μ L or less.

In another embodiment described herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: means for holding a plurality of sample vessels in at least one fixed orientation; means for thermally controlling the temperature of said sample vessel to be within a desired range of about 0 ℃ to 10 ℃; wherein the means for containing the plurality of sample vessels is removable from the transport container. Optionally, the vessel receiving space is configured to receive an evacuated blood collection tube having an internal volume of about 2ml or less. In embodiments, the vessel receiving space is configured to receive a vacuum collection tube having an internal volume of about 1ml, or less than about 500 μ L, or less than about 250 μ L, or less than about 100 μ L, or less than about 50 μ L or less.

It will be appreciated that some embodiments may include a kit comprising a shipping container as set forth in any of the above embodiments. Optionally, the kit comprises a shipping container and instructions for its use.

In one embodiment described herein, a method for providing a whole blood sample and/or a portion thereof from a sender to a recipient is described. The method comprises transporting a package comprising a sample vessel until, at least when a whole blood sample and/or a portion thereof reaches the recipient, the sample vessel comprises one or more channels containing (a) a whole blood sample and/or a portion thereof having a flow regime of less than or equal to about 200 microliters (ul) in volume and (b) one or more reagents for preserving one or more analytes in the whole blood sample and/or the portion thereof for analysis, and wherein the depositing results in delivery of the sample vessel to the recipient. By way of non-limiting example, transporting the sample vessel may occur through the use of a package delivery service, courier, or other shipping service.

In one embodiment described herein, a method for preparing a whole blood sample for delivery to a sample processing station is described that includes storing a whole blood sample having a flow regime and a sample vessel having a volume of less than or equal to about 200ul with a delivery service for delivering the sample vessel to a sample processing location for processing the whole blood sample. The sample vessel may be prepared by (a) drawing the whole blood sample from a subject via a capillary channel and (b) placing the whole blood sample in the sample vessel, wherein the whole blood sample is preserved in a fluid state with one or more reagents contained in the capillary channel and/or the sample vessel.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the sample in some embodiments may be in a semi-solid state or a gel state. This may occur after the sample is in the sample vessel. Optionally, the delivery service is a postal delivery service. Optionally, the blood sample is collected from a subject at a point of care location. Optionally, the point of care location is the subject's home. Optionally, the point of care location is a location of a healthcare provider.

In another embodiment described herein, a method for processing a whole blood sample includes receiving a sample vessel from a package delivery service at a processing station, the sample vessel having less than or equal to about 200ul of a whole blood sample, wherein the sample vessel receives the whole blood sample at the processing station and has a fluid state; and performing at least one pre-analytical and/or analytical assay on the fluidized whole blood sample at the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the assay has one or more steps. Optionally, the sample vessel is contained in a housing having one or more environmental control zones. Optionally, the enclosure is adapted to control the humidity of each environmental control zone. Optionally, the housing is adapted to control the pressure of each environmental control zone.

In yet another embodiment described herein, a computer-implemented method for queuing blood samples for processing at a processing location is provided. The method comprises (a) identifying a geographic location of a transport container having a blood or other bodily fluid sample by means of a geolocation system having a computer processor; (b) estimating, with the aid of a computer processor, a delivery time of the transport container to the processing location; and (c) providing a notification for preparation work based on the estimated delivery time for processing the sample at the processing location.

In yet another embodiment described herein, a method for preparing a whole blood sample for delivery to a sample processing station is described, the method comprising employing a delivery service to deposit a sample vessel having a fluent whole blood sample, the delivery service for delivering the sample vessel to a sample processing location for processing the whole blood sample, wherein the sample vessel is prepared by (a) using a device to draw the whole blood sample from a subject and (b) placing the whole blood sample in the sample vessel.

Optionally, the depositing may comprise picking up and/or putting down of the sample vessel. Alternatively, the processing may include pre-analysis processing, and post-analysis processing of the sample. Optionally, the delivery service may comprise a delivery service of the subject or a third party delivery service. Optionally, the whole blood sample is stored in a fluid state with one or more reagents contained in the capillary channel or the sample vessel.

In yet another embodiment described herein, a method for processing a whole blood sample at a processing station is provided. The method includes receiving a sample vessel having a whole blood sample from a delivery service at the processing station, wherein the sample vessel is prepared by (a) drawing the whole blood sample from a subject using a collection device and (b) placing the whole blood sample in the sample vessel. The method further comprises performing at least one pre-analytical or analytical assay on the whole blood sample at the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the time for completing the process is provided by the estimated delivery time by means of a computer processor. Optionally, the method comprises queuing the sample vessel for processing after the processing location estimates the delivery time of the sample vessel. Optionally, the geographical location of the sample vessel is identified by means of a communication network.

In one embodiment described herein, a computer-implemented method for providing an estimated completion time for processing a blood sample is described. The method includes receiving information about a transport container having a blood sample taken from a subject transported to a processing station (for sample processing) by a delivery service. The method further comprises calculating, with the aid of a computer processor, a location of the blood sample in a processing queue at the processing station, wherein the prediction is based on (i) information about a location of blood or other bodily fluid samples from other subjects in the processing queue, and (ii) information about a geographic location of other sample vessels (having blood samples from other subjects) associated with the sample vessel (having a blood sample removed from the subject). The method comprises predicting a time for processing the blood sample at the processing station after delivering the sample vessel to the processing station by the delivery service; and providing the subject or a healthcare provider associated with the subject with an estimated time for processing a blood sample from the subject based on the prediction and the estimated time to deliver the sample vessel to the processing station, the estimated time measured from a point in time at which the sample vessel was deposited with the delivery service. Optionally, the sample is transported to a plurality of processing stations. It should be understood that processing as used herein is to be broadly construed and may include one or more pre-analysis, and/or post-analysis steps.

In yet another embodiment described herein, a computer-implemented method for providing an estimated time to completion for processing a blood sample from a subject is described. The method includes receiving information about a transport container having at least one blood or bodily fluid sample removed from the subject that is transported by a delivery service to a processing station (for sample processing). The method further comprises calculating, with the aid of a computer processor, a position of the blood sample in a processing queue at the processing station, wherein the prediction is based on (i) information about a position of a blood sample from another subject in the processing queue, and (ii) information about a geographic location of another sample vessel (having a blood sample from another subject) associated with the transport container (having a blood sample removed from the subject). The method includes predicting a time for processing the blood sample at the processing station after delivering the transport container to the processing station by the delivery service; and allocating, at the processing station, one or more resources for processing the blood sample after delivery to the processing station based on the prediction and the estimated time to deliver the transport container to the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the transport container has an information storage unit that allows the transport container to be identified by the delivery service and/or the processing location. Optionally, the information storage unit is a Radio Frequency Identification (RFID) tag. Optionally, the information storage unit is a barcode. Optionally, the information storage unit is a microchip. Optionally, the transport container includes one or more sensors for collecting one or more of a temperature of the bodily fluid sample (e.g., a blood sample), a pressure of the sample vessel, a pH of the sample, a turbidity of the sample, a viscosity of the sample, or other characteristics of the sample. Optionally, the processing location processes the collected bodily fluid sample on demand. Optionally, the transport container comprises a geolocation device for providing a location of the sample vessel. Optionally, the anti-clotting agent is selected from heparin, ethylenediaminetetraacetic acid, anticoagulants, or other additives. Optionally, the transport container (wherein the container receiving space is configured to receive a evacuated blood collection tube) is configured to receive an evacuated sample collection tube having a partial vacuum of at most about 30% vacuum, or at most about 40% vacuum, or at most about 50% vacuum, or at most about 60% vacuum, or at most about 70% vacuum, or at most about 80% vacuum, or at most about 90% vacuum.

In embodiments described herein that relate to a first vessel and a second vessel, in certain embodiments, the internal volumes of the first vessel and the second vessel are each 1000 microliters, 750 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, 2 microliters or less. In embodiments described herein that relate to a first vessel and a second vessel, in certain embodiments, the first vessel and the second vessel each have an internal volume of no more than 1000 microliters, 750 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters. In embodiments described herein involving one or more vessels, in certain embodiments, each of the one or more vessels has an internal volume of 1000 microliters, 750 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, 2 microliters or less. In embodiments described herein involving one or more vessels, in certain embodiments, the internal volume of the one or more vessels is no more than 1000 microliters, 750 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters.

In embodiments described herein involving a first vessel and a second vessel, each vessel contains a portion of a small volume bodily fluid sample, in certain embodiments, neither the first vessel nor the second vessel contains a portion of the small volume bodily fluid sample having a volume of greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters.

In embodiments described herein that relate to a vessel containing a small volume bodily fluid sample, in certain embodiments, the small volume bodily fluid sample in the vessel has a volume no greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters.

In embodiments described herein that relate to one or more vessels comprising a bodily fluid sample, in certain embodiments, at least one of the one or more vessels comprises a bodily fluid sample that fills at least 99%, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10%, or 5% of the interior volume of the vessel. In embodiments described herein that relate to one or more vessels comprising a bodily fluid sample, in certain embodiments, all vessels of the one or more vessels comprise a bodily fluid sample that fills at least 99%, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10%, or 5% of the internal volume of the vessel.

In embodiments described herein involving a sample collection site and a sample receiving site, in embodiments, the sample collection site and the sample receiving site may be in the same room, building, campus or building complex. In embodiments described herein involving a sample collection site and a sample receiving site, in embodiments, the sample collection site and the sample receiving site may be in different rooms, buildings, parks, or groups of buildings. In embodiments, the sample collection site and the sample receiving site may be separated by 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. In embodiments, the sample collection site and the sample receiving site may be separated by no more than 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 1000 kilometers. In embodiments, the sample collection site and the sample receiving site may be separated by 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 no more than 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 1000 kilometers. 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 embodiments described herein involving a vessel containing at least a portion of a small volume of bodily fluid sample transported from a sample collection site to a sample receiving site, in embodiments, the bodily fluid sample may remain in liquid form during transport of the vessel. In embodiments described herein involving two or more vessels, each vessel contains at least a portion of a small volume of bodily fluid sample transported from a sample collection site to a sample receiving site, in embodiments, the bodily fluid sample in each vessel may remain in liquid form during transport of the vessel.

In embodiments described herein involving one or more vessels transported from a sample collection site to a sample receiving site, in embodiments, the one or more vessels may be transported in a transport container. In embodiments described herein that relate to one or more vessels transported in a transport container, in embodiments, the one or more vessels may be positioned in the transport container in an array, and the array may comprise at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, or 100 vessels per square inch when viewed from top to bottom.

In embodiments described herein that involve transporting one or more vessels in a transport container, in embodiments, the transport container can comprise bodily fluid samples from at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, or 100 different subjects.

In embodiments described herein involving a vessel comprising at least a portion of a bodily fluid sample, in embodiments, the vessel may comprise an anticoagulant. In embodiments involving two or more vessels each comprising a portion of a bodily fluid sample from a subject, in embodiments, at least one or all of the vessels may comprise an anticoagulant. In embodiments, when two or more vessels each comprising a portion of a bodily fluid sample from a subject further each comprise an anticoagulant, the vessels may comprise the same anticoagulant or different anticoagulants. The anticoagulant in the vessel may be, for example, heparin or EDTA.

In the methods described herein that involve transporting a bodily fluid sample in one or more vessels from a sample collection site to a sample receiving site, in embodiments, the bodily fluid sample may arrive at the sample receiving site no more than 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, 30 minutes, 20 minutes, 15 minutes, 10 minutes, or 5 minutes after obtaining the bodily fluid sample from the subject.

In the methods described herein that involve transporting at least one vessel from a sample collection site to a sample receiving site, in embodiments, the method may further comprise centrifuging the vessel prior to transporting it. In the methods described herein that involve transporting a plurality of vessels from a sample collection site to a sample receiving site, in embodiments, the method may further comprise centrifuging the plurality of vessels prior to transporting them.

In the methods described herein involving transporting at least a first vessel from a sample collection site to a sample receiving site, in embodiments, the first vessel is inserted into a sample processing device comprising an automated fluid processing device at the sample receiving site and prior to removing a sample from the first vessel. In the methods described herein involving transporting at least a first vessel and a second vessel from a sample collection site to a sample receiving site, in embodiments, the first vessel and second vessel are inserted into a sample processing device comprising an automated fluid processing device at the sample receiving site and prior to removing a sample from the first vessel. In an embodiment, when a vessel containing a sample is inserted into a sample processing device comprising an automated fluid processing device, the sample may be removed from the vessel by the automated fluid processing device. In an embodiment, prior to inserting a vessel containing a sample into a sample processing device comprising an automated fluid processing device, the vessel is inserted into a cartridge and then the cartridge is inserted into the sample processing device. The cartridge may contain any number of vessels containing the sample, such as at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 50, or 100 vessels. The cartridge may also contain one or more reagents for performing one or more laboratory tests on the sample. In embodiments, a cartridge may contain all of the reagents necessary to perform all of the assays to be performed with one or more samples in the cartridge.

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

In embodiments provided herein involving the transport of one or more vessels, each vessel containing at least a portion of a bodily fluid sample from a sample collection site to a sample receiving site, in embodiments, one or more steps of any number of laboratory tests may be performed on a portion of the at least a portion of the bodily fluid sample in the vessel. For example, in embodiments, one or more steps of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, or 1000 or more different laboratory tests may be performed on a portion of the at least a portion of the bodily fluid sample. Various different laboratory tests may use a single portion of the bodily fluid sample, or in embodiments, more than one different laboratory test may be performed with a particular portion of the bodily fluid sample. The different laboratory tests may be of the same type, of different types, or a mixture of the same type and different types. The one or more vessels may be, for example, a first vessel, or a first vessel and a second vessel.

In embodiments, when a bodily fluid sample from a subject transported according to a system or method provided herein is used for more than one laboratory test, each laboratory test may use no more than 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, 0.05, or 0.01 equivalents of pure bodily fluid sample (e.g., undiluted whole blood, saliva, or urine) per test.

In embodiments provided herein that relate to obtaining a plurality of vessels at a sample collection site, the plurality of vessels collectively comprising a small volume bodily fluid sample from a subject, in embodiments, the total volume of the small volume bodily fluid sample obtained from the subject between all of the plurality of vessels can be no greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters.

In embodiments provided herein that involve transporting a vessel containing at least a portion of a bodily fluid sample from a sample collection site to a sample receiving site, an original sample is removed from the vessel at the sample receiving site, and then a diluted sample is generated from the original sample, which in embodiments may be generated stepwise or continuously. In embodiments, the diluted sample can have a total volume of no more than 1000 microliters, 900 microliters, 800 microliters, 700 microliters, 600 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters. In embodiments, the diluted sample may be diluted at least 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, 10-fold, 15-fold, 20-fold, 50-fold, 100-fold, 200-fold, 300-fold, 400-fold, 500-fold, 1000-fold, 5,000-fold, 10,000-fold, 50,000-fold, or 100,000-fold relative to the original sample.

In embodiments provided herein that involve transporting at least a first vessel and a second vessel from a sample collection site to a sample receiving site, the first vessel and second vessel each comprising a portion of a small volume bodily fluid sample obtained from the subject, in embodiments, at the sample receiving site a first vessel original sample can be removed from the first vessel and a second vessel original sample can be removed from the second vessel. A first vessel dilution sample may be generated from the first vessel raw sample. A second vessel dilution sample may be generated from the second vessel original sample. The first vessel diluted sample and the second vessel diluted sample may have the same or different volumes and dilutions. In embodiments, a plurality of different diluted samples may be generated from one or both of the first vessel raw sample or second vessel raw sample. The different diluted samples may be used for one or more different laboratory tests, which may be of different types. In embodiments, a first vessel dilution sample may be a vessel diluted at least 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, 10-fold, 15-fold, 20-fold, 50-fold, 100-fold, 200-fold, 300-fold, 400-fold, 500-fold, 1000-fold, 5,000-fold, 10,000-fold, 50,000-fold, or 100,000-fold relative to the first vessel original sample and having no more than 1000 microliters, 900 microliters, 800 microliters, 700 microliters, 600 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 vessels, 3 microliters, or 2 microliters, while a second dilution sample may be a vessel diluted at least 2-fold relative to the second vessel original sample 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000 or 100,000 times in total and having a total volume of no more than 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 2 microliters.

In embodiments provided herein that relate to obtaining a vessel at a sample collection site, the vessel containing a small volume bodily fluid sample obtained from a subject, in embodiments, the volume of the small volume bodily fluid sample in the vessel can be no greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, or 2 microliters.

In embodiments provided herein that involve obtaining a vessel at a sample collection site and transporting the vessel from the sample collection site to a sample receiving site, the vessel contains a small volume of bodily fluid sample obtained from a subject, which in embodiments can be divided into any number of portions, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, or 1000 different portions. The moieties may be diluted to the same or different amounts and may be used for, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, or 1000 or more different laboratory tests.

In embodiments provided herein that involve obtaining at a sample collection site at least one vessel comprising at least a portion of a small volume of bodily fluid sample from a subject, in embodiments, the obtaining step can comprise collecting the small volume of bodily fluid sample from the subject (e.g., from a finger prick or a venous draw).

In embodiments provided herein that relate to performing at least a portion of a laboratory test in an assay unit, in embodiments, the assay unit may be movable, such as by a fluid handling device. In embodiments comprising two or more assay units, in embodiments, the assay units may be independently movable.

In embodiments provided herein that relate to the transportation of one or more vessels containing bodily fluid samples, in some embodiments, the vessels may have any of the characteristics of the vessels described herein or other vessels suitable for storing bodily fluids. In some embodiments, the vessel may be loaded with a bodily fluid sample by any of the devices or methods provided herein, or by other suitable techniques for loading vessels having small internal volumes. For example, in certain embodiments, a vessel to be transported according to the systems or methods provided herein may be loaded with a sample by a syringe or pipette tip.

Optionally, at least one embodiment of the sample collection devices herein can separate a single blood sample into different vessels for different pre-analytical processes. This may be achieved by a fluid pathway in the device and/or by a different inlet port on the device.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

Is incorporated by reference

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

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

Fig. 2A-2C illustrate perspective views of a sample collection device without a cap according to one embodiment as described herein.

Fig. 3A-3B illustrate side and cross-sectional views of a sample collection device according to one embodiment as described herein.

Fig. 4A-4B illustrate side and cross-sectional views of a sample collection device according to one embodiment as described herein.

Fig. 5A-5B illustrate perspective views of a sample collection device according to another embodiment as described herein.

Fig. 6A-6B illustrate side views of a sample collection device according to one embodiment as described herein.

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

Fig. 9A-9C illustrate side cross-sectional views of a sample collection device at various stages of use according to one embodiment as described herein.

Fig. 10A-10B illustrate perspective views of a sample collection device according to one embodiment as described herein.

Fig. 11A-11Z show views of various examples of sample collection devices according to embodiments as described herein.

Fig. 12 shows a schematic view of a tip portion of a sleeve and associated balance of forces associated with one embodiment as described herein.

Fig. 13A-13D show views of respective collection devices having upwardly facing collection positions according to embodiments as described herein.

Fig. 14-15 show various views of a collection device having a single collection location according to one embodiment as described herein.

16-17 illustrate perspective and end views of a sample collection device using vessels having identifiers according to one embodiment as described herein.

Fig. 18A-18G show various views of a sample vessel according to embodiments as described herein.

Fig. 19A-19C illustrate views of various embodiments of the front end of a sample collection device.

Fig. 20-21 illustrate various embodiments of sample collection devices with integrated tissue penetrating members.

Fig. 22 illustrates a perspective view of a collection device for use with a blood vessel or other tissue penetrator and a sample collector, according to embodiments described herein.

Fig. 23-28 show various views of a collection device for use with various sample collectors, according to embodiments described herein.

Fig. 29A-29C show schematic diagrams of various embodiments as described herein.

Fig. 30-31 show schematic diagrams of methods according to embodiments described herein.

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

Fig. 33-37 illustrate yet another embodiment of a collection device as described herein.

Fig. 38A-39 illustrate various views of a thermally controlled transport container conveyance device, according to at least one embodiment described herein.

Fig. 40A-40C show schematic diagrams of various embodiments described herein.

Fig. 41 illustrates a perspective view of a portion of a transport container having a plurality of sample vessels therein, according to at least one embodiment described herein.

Fig. 42 is an exploded perspective view of a portion of a shipping container having a plurality of sample vessels 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 view of a sample collection and transport process according to yet another embodiment described herein.

Fig. 46 illustrates a sample collection device according to one embodiment described herein.

Fig. 47 shows a schematic view of a system for unloading sample vessels from transport containers according to one embodiment described herein.

Fig. 48 is a graph illustrating the stability of an analyte in a sample in a vessel provided herein.

Fig. 49-51 illustrate one non-limiting example of detection according to at least one embodiment described herein.

Fig. 52-55 illustrate various views of devices and systems according to embodiments herein.

Fig. 56-59 illustrate various views of a sample transport device according to at least some embodiments herein.

Detailed Description

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. It may be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" can include mixtures of materials, reference to "a compound" can include compounds, and the like. The references cited herein are hereby incorporated by reference in their entirety, except to the extent that they conflict with the teachings set forth explicitly in this specification.

In this specification and in the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings:

"optional" or "optionally" means that the subsequently described event may or may not occur, such that the description includes instances where the event occurs and instances where it does not. For example, if the device optionally contains features for a sample collection well, this means that the sample collection well may or may not be present, and thus, the description includes both structures in which the device is provided with the sample collection well and structures in which the sample collection well is not present.

The term "substantially" as used herein means more than a minimum or insignificant amount; and "substantially" means more than minimally or not significantly. Thus, for example, the phrase "substantially different," as used herein, refers to a sufficiently high degree of difference between two numerical values that one of ordinary skill in the art would consider the difference between the two values to be statistically significant within the context of the property measured by the values. Thus, the difference between two values substantially different from each other as a function of the reference or comparison value is typically greater than about 10%, and may be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, preferably greater than about 50%.

As used herein, a "sample" may be, but is not limited to, a blood sample or a portion of a blood sample, and may be any suitable size or volume, and is preferably a small size or volume. In some embodiments of the assays and methods disclosed herein, measurements can be made using small volumes of blood samples or no more than a small volume fraction of a blood sample, where a small volume includes no more than about 5 mL; or comprises no more than about 3 mL; or comprises no more than about 2 mL; or comprises no more than about 1 mL; or comprises no more than about 500 μ L; or comprises no more than about 250 μ L; or comprises no more than about 100 μ L; or comprises no more than about 75 μ L; or comprises no more than about 50 μ L; or comprises no more than about 35 μ L; or comprises no more than about 25 μ L; or comprises no more than about 20 μ L; or comprises no more than about 15 μ L; or comprises no more than about 10 μ L; or comprises no more than about 8 μ L; or comprises no more than about 6 μ L; or comprises no more than about 5 μ L; or comprises no more than about 4 μ L; or comprises no more than about 3 μ L; or comprises no more than about 2 μ L; or comprises no more than about 1 μ L; or comprises no more than about 0.8 μ L; or comprises no more than about 0.5 μ L; or comprises no more than about 0.3 μ L; or comprises no more than about 0.2 μ L; or comprises no more than about 0.1 μ L; or comprises no more than about 0.05 μ L; or comprises no more than about 0.01 μ L.

The term "point-of-service location" as used herein may include a location in which a subject may receive services (e.g., detection, monitoring, treatment, diagnosis, guidance, sample collection, ID verification, medical services, non-medical services, etc.) and may include, but is not limited to, the residence of the subject, the workplace of the subject, the location of a healthcare provider (e.g., a doctor), a hospital, an emergency room, an operating room, a clinic, the office of a healthcare professional, a laboratory, a retailer [ e.g., a pharmacy (e.g., a retail pharmacy, a clinical pharmacy, a hospital pharmacy), a pharmacy, a supermarket, a grocery store, etc. ], vehicles (e.g., cars, boats, trucks, buses, airplanes, motorcycles, ambulances, mobile units, fire trucks/fire trucks, emergency vehicles, law enforcement vehicles, police cars, or other vehicles configured to transport a subject from one point to another, etc.), A roving healthcare unit, a mobile unit, a school, a daycare center, a security check site, a battle site, a medical assisted living dwelling, a government agency, an office building, a tent, a bodily fluid sample collection site (e.g., a blood collection center), a site at or near the entrance to the site that the subject may wish to enter, a site at or near the device that the subject may wish to visit (e.g., the location of a computer-if the subject wishes to visit the computer), the location at which the sample is received by the sample processing device, or any other point of service location described elsewhere herein.

As used herein, a "bodily fluid" can be any fluid obtained or obtainable from a subject. The bodily fluid may be, for example, blood, urine, saliva, tears, sweat, bodily secretions, bodily excretions, or any other fluid derived or obtained from the subject. In particular, bodily fluids include, but are not limited to, blood, serum, plasma, bone marrow, saliva, urine, gastric fluid, spinal fluid, tears, stool, mucus, sweat, cerumen, oil, glandular secretions, cerebrospinal fluid, semen, vaginal fluid, tissue fluid derived from tumor tissue, ocular fluid, fetal fluid, amniotic fluid, cord blood, lymph, luminal fluid, sputum, pus, meconium, breast milk, and/or other secretions or excretions.

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

As used herein, a "sample collection unit" and/or any other portion of a device may be capable of receiving a single type of sample or multiple types of samples. For example, the sample collection unit may be capable of receiving two different types of bodily fluids (e.g., blood, tears). In another example, the sample collection unit may be capable of receiving two different types of biological samples (e.g., urine samples, stool samples). Various types of samples may or may not be fluid, solid, and/or semi-solid. For example, the sample collection unit may be capable of receiving one or more, two or more, or three or more of the bodily fluid, exudate and/or tissue samples.

As used herein, "non-wicking, non-matrix form" means that the liquid or suspension is not absorbed or pulled into by the fabric, mesh, fibrous mat, absorbent material, absorbent structure, osmotic network of fibers, etc., which alters the form of the liquid or suspension or traps components of the sample therein to such an extent that the integrity of the sample in liquid form is altered and the sample cannot be extracted in liquid form for sample analysis while still maintaining the integrity of the sample.

The term "sample processing system" as used herein refers to a device or system configured to facilitate imaging, detection, positioning, repositioning, retention, uptake, and storage of a sample. In one example, the robot with pipetting capability is a sample processing system. In another example, a pipette, which may or may not have (other) robotic capabilities, is a sample processing system. The sample processed by the sample processing system may or may not include a fluid. The sample processing system may be capable of transporting bodily fluids, secretions, or tissues. The sample processing system may be capable of transporting one or more substances within the device that are not necessarily samples. For example, the sample processing system may be capable of transporting a powder that is reactive with one or more samples. In some cases, the sample processing system is a fluid processing system. The fluid handling system may include various types of pumps and valves or pipettes, which may include, but are not limited to, positive displacement pipettes, vented pipettes, and suction pipettes. The sample processing system may transport samples or other substances by means of robots as described elsewhere herein.

The term "healthcare provider" as used herein refers to a doctor or other healthcare professional who provides medical treatment and/or medical advice to a subject. The healthcare professional can include a person or entity associated with the healthcare system. Examples of healthcare professionals can include doctors (including general and specialist doctors), surgeons, dentists, audiologists, speech pathologists, physician assistants, nurses, midwives, pharmacists/pharmacists, dieticians, therapists, psychologists, massagers, clinical physicians, physical therapists, phlebotomists, occupational therapists, optometrists, emergency medical technicians, paramedics, medical laboratory technicians, medical prosthesis technicians, radiology technicians, social workers, and numerous other human resources trained to provide some type of healthcare service. The healthcare professional may or may not prescribe a qualification. Healthcare professionals may be working at or affiliated with hospitals, healthcare sites, and other service providers, or may also work with academic training, research, and management organizations. Some healthcare professionals may provide care and treatment services to patients in private or public places, community centers, or gathering places or mobile units. Community healthcare workers may work outside of the official healthcare facility. Healthcare service managers, healthcare record and health information technicians, and other support personnel may also be healthcare professionals or affiliated with healthcare providers. A healthcare professional may be an individual or an organization that provides preventive, therapeutic, promotional, or rehabilitative healthcare services to an individual, a family, or a community.

In some embodiments, the healthcare professional may already be familiar with the subject or have communicated with the subject. The subject may be a patient of a healthcare professional. In some cases, the healthcare professional may have requested that the subject follow the medical advice for clinical testing. A healthcare professional may have instructed or advised the subject to undergo clinical testing at a service shop location or by a laboratory. In one example, the healthcare professional can be a primary care physician of the subject. The healthcare professional may be any type of physician of the subject (including a general practitioner, a referral practitioners, or alternatively the patient's own physician and/or specialist selected and contacted by the telemedicine service). The healthcare professional can be a healthcare professional.

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

The term "cell" as used in the context of biological samples encompasses samples that are substantially similar in size to a single cell, including but not limited to vesicles (such as liposomes), cells, virosomes, and substances associated with small particles such as beads, nanoparticles, or microspheres. Characteristics include, but are not limited to, size; a shape; temporal and dynamic changes such as cell movement or proliferation; particle size; whether the cell membrane is intact; internal cellular contents including, but not limited to, protein contents, protein modifications, nucleic acid contents, nucleic acid modifications, organelle contents, nuclear structures, nuclear contents, internal cellular structures, contents of internal vesicles, ion concentrations, and the presence of other small molecules such as steroids or drugs; and cell surface (cell membrane and cell wall) markers including proteins, lipids, carbohydrates and modifications thereof.

As used herein, "sample" refers to the entire original sample or any portion thereof, unless the context clearly dictates otherwise.

The present invention provides systems and methods for multipurpose analysis of samples or health parameters. The sample may be collected and one or more sample preparation steps, assay steps, and/or detection steps may be performed on the device. The various aspects of the invention described herein may be applicable to any of the specific applications, systems, and devices set forth below. The invention may be applied as a stand-alone system or method, or as part of an integrated system, such as in a system involving point-of-service healthcare. In some embodiments, the system may include externally directed imaging technology (such as ultrasound or MRI), or be integrated with peripherals for integrated imaging and other health detection or services. It is to be understood that different aspects of the present invention may be understood and practiced individually, collectively, or in combination with each other.

Referring to fig. 1A-1B, one embodiment of a sample collection device 100 will now be described. In this non-limiting example, the sample collection device 100 can include a collection device body 120, a stand 130, and a base 140. In some cases, a cap 110 may optionally be provided. In one embodiment, the cap may be used to protect the opening, keep it clean, and to shield the tip of the covered blood after collection. Alternatively or additionally, the cap may also be used to limit the flow rate by controlling the amount of displacement provided to the capillary during transfer of the sample fluid into the sample vessel. Some embodiments may include a vent passage in the cap (either permanently open or may be operatively closed), while other embodiments do not. Optionally, the collection device body 120 may include a first portion of the device 100 having one or more collection pathways (such as, but not limited to, collection channels 122a, 122B) therein, which may be capable of receiving the sample B. Fig. 1A shows sample B only partially filling the channels 122a, 122B, it being understood that in most embodiments, the channels will be completely filled by sample B when the filling process is complete, although partial filling is not excluded in some alternative embodiments. In this embodiment, the base 140 may have one or more fill indicators 142a, 142b, such as, but not limited to, optical indicators, which may provide an indication of whether the sample has reached one or more vessels housed in the base. It should be understood that although the indication may be by way of visual indication, other indication methods such as audio, vibration or other indication methods may be used instead of or in combination with the indication method. The indicator may be located on at least one of the vessels. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Although not shown for ease of illustration, the bracket 130 may also include one or more such fill indicators: the fill indicator shows whether the desired fill level has been reached in the channels 122a and 122 b. This may be in place of or in addition to fill indicators 142a, 142 b. Of course, the one or more pathway filling indicators may be located on different components and are not limited to being on the support 130. It should be understood that although such indication of fill level in one or more of the channels 122a and 122b may be by way of visual indication, other indication methods, such as audio, vibration, or other indication methods, may be used instead of or in combination with the indication method. The indicator may be located on at least one of the collection pathways. Optionally, indicators are located on all of the collection paths.

In this embodiment, the bracket 130 may be used to couple the body 120 and the base 140 to form an integrated device. It should be understood that although the device body 120, the stand 130, and the base 140 are illustrated as separate components, one or more of these components may be integrally formed to simplify manufacturing, and such integration is not precluded herein.

In some embodiments herein, a cap 110 may optionally be provided. In one non-limiting example, the cap can fit over a portion of the collection device body 120. The cap 110 may be detachable from the collection device body 120. In some cases, the cap 110 may be completely detachable from the collection device body 120, or may remain partially connected to the collection device body, such as but not limited to being hinged or otherwise attached to the collection device. The cap 110 can cover a portion of the collection device body 120 that contains the exposed ends of the one or more channels therein. When the cap is in place, the cap 110 may prevent materials such as air, fluids, or particulates from entering the channels within the body of the device. Alternatively, cap 110 may be attached to collection body 120 using any technique known or hereafter developed in the art. For example, the cap may be snap-fit, screw-on, friction-fit, clipped-on, have a magnetic portion, tied to, utilize a resilient portion, and/or may be removably connected to the collection device body. The cap may form a fluid-tight seal with the collection device body. The cap may be formed of an opaque, transparent or translucent material.

In one embodiment, the collection device body 120 of the sample collection device may contain at least a portion of one or more collection pathways therein, such as, but not limited to, channels 122a, 122 b. It should be understood that collection passages that are not channels are not excluded. The collection device body may be connected to a holder 130 that may contain a portion of one or more channels therein. The collection device body may be permanently fixed to the stand or may be removable with respect to the stand. In some cases, the collection device body and the bracket may be formed from a single, unitary piece. Alternatively, the collecting device body and the holder may be formed of separate pieces. During operation of the device, the collecting device and the holder do not move relative to each other.

Alternatively, the collection device body 120 may be formed entirely or partially of a light transmissive material. For example, the collection device body may be formed of a transparent or translucent material. Optionally, only selected portions of the body are transparent or translucent to visualize the one or more fluid collection channels. Optionally, the body comprises an opaque material, but openings and/or windows may be formed in the body to show the fill level therein. The collection device body may enable a user to view the channels 122a, 122b within and/or through the device body. The channel may be formed of a transparent or translucent material that may allow a user to see if sample B has passed through the channel. The channels may have substantially the same length. In some cases, the bracket 130 may be formed of an opaque material, a transparent material, or a translucent material. The holder may or may not have the same optical properties as the collection device body. The holder may be formed of a different material from the collecting device body, or formed of the same material as the collecting device body.

The collection device body 120 can have any shape or size. In some examples, the collection device body can have a circular, oval, triangular, quadrilateral (e.g., square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may remain the same or may vary along the length of the collection device body. In some cases, the collection device body can have less than or equal to about 10cm²、7cm²、5cm²、4cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.8cm²、0.5cm²、0.3cm²Or 0.1cm²Cross-sectional area of (a). The cross-sectional area may vary or may remain the same along the length of the collection device body 120. The collection device body can have a length of less than or equal to about 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.5cm, or 0.1 cm. The collection device body 120 may have a length that is greater or less than the cap, holder, or base, or equal to the cap, holder, or base. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the collection passages, such as but not limited to channels 122a, 122b, may also have a selected cross-sectional shape. Some embodiments of the channel may have the same cross-sectional shape along the entire length of the channel. Alternatively, the cross-sectional shape may remain the same or may vary along the length. For example, some embodiments may have one shape at one location along the length of the channel and a different shape at one or more different locations. Some embodiments may have one channel with one cross-sectional shape and at least one other channel with a different cross-sectional shape. By way of non-limiting example, some embodiments may have a circular, elliptical, triangular, quadrilateral (e.g., square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may be the same or may vary for the body, support and base. Some embodiments may select the shape to maximize the volume of liquid that can be contained in the channel for a particular channel width and/or height. Some embodiments may have one of the channels 122a, 122b with one cross-sectional shape and the other channel with a different cross-sectional shape. In one embodiment, the cross-sectional shape of the channel may help to maximize the volume therein, but optionally it may also optimize the capillary pull on the blood. This will allow for a maximized fill rate. It should be understood that in some embodiments, the cross-sectional shape of the channel may directly affect the capillary force. By way of non-limiting example, a volume of sample may be contained in a shallow, wide channel or a circular channel, both of which contain the same volume, but one channel may be more desirable than the other for fill velocity, lower likelihood of air entrapment, or factors related to channel performance.

While the channel can have any shape or size, some embodiments are configured such that the channel exhibits capillary action when in contact with the sample fluid. In some cases, the channel can have a width of less than or equal to about 10mm²、7mm²、5mm²、4mm²、3mm²、2.5mm²、2mm²、1.5mm²、1mm²、0.8mm²、0.5mm²、0.3mm²Or 0.1mm²Cross-sectional area of (a). The cross-sectional size may remain the same or may vary along the length. Some embodiments may beA larger force along one length and then a smaller force over another length. The cross-sectional shape may remain the same or may vary along the length. Some of the channels are straight in configuration. Some embodiments may have a curved or other shaped path shape, alone or in combination with straight portions. Some embodiments may have different orientations within the device body 120. For example, one or more channels may be tilted downward, upward, or not tilted as they carry fluid away from an initial collection point on the device while the device remains substantially horizontal.

The channels 122a, 122b may be supported by the device body 120 and/or the stand 130. In some cases, the entire length of the channel may be contained within the combination of the device body and the stent. In some cases, a portion of the channel can be located within the device body, and a portion of the channel can be located within the cradle. The position of the channel may be fixed by the device body and/or the holder. In some embodiments, the channel may be defined as a lumen within the hollow needle. In some embodiments, the channels are defined on only three sides, with at least one side being open. Optionally, a cover layer separate from the body may define a side that would otherwise be open. Some embodiments may define different sides of the channel with different materials. These materials may be provided entirely by the body, or they may be provided by different parts of the collecting device. Some embodiments may have channels that all lie in the same plane. Optionally, some embodiments may have a shape that brings at least a portion of the channel to a different plane and/or orientation. Alternatively, some channels may be entirely in different planes and/or orientations.

In some cases, multiple channels may be provided. In some embodiments, one channel is split into two or more channels. Optionally, some channels are divided into an even larger number of channels. Some channels may include control mechanisms such as, but not limited to, valves for directing flow in one or more channels. At least a portion of the channels may be substantially parallel to each other. Alternatively, no portion of the channels need be parallel to each other. In some cases, at least a portion of the channels are not parallel to each other. Alternatively, the channel may be slightly curved. Alternatively, the channel may have one cross-sectional area at one location and a smaller cross-sectional area at a different location along the channel. Alternatively, the channel may have one cross-sectional area at one location and a larger cross-sectional area at a different location along the channel. For some embodiments of the Y-shaped design, it may be desirable that the channel will have a vent hole placed appropriately to define a sample for each vial so that there is no sample pulled from other channels or cross-contamination. By way of non-limiting example, one embodiment having vent holes is shown in fig. 11I.

A base 140 may be provided within the sample collection device. The base may be connected to a bracket 130. In some cases, a portion of the base may be insertable within the cradle, and/or a portion of the cradle may be insertable within the base. The base may be movable relative to the support. In some cases, a sample collection device can have a longitudinal axis that extends along the length of the sample collection device. The base and/or the support are movable relative to each other in the direction of said longitudinal axis. The base and/or the support may be capable of moving a limited distance relative to each other. Alternatively, the base may be fixed relative to the support. The base may be provided at an end of the sample collection device opposite the end of the sample collection device that includes the cap 110. Optionally, some embodiments may include an integrated base/vessel component, such that there is no longer a separate vessel assembled into the base part. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The base 140 may receive one or more vessels therein. The vessel may be in fluid communication with the channel and/or may be brought into fluid communication with the channel. One end of the channel may be located within the vessel or may be brought into the vessel. The base may have one or more optical indicators 142a, 142b that may provide a visual indication of whether the sample has reached one or more vessels housed in the base. In some embodiments, the optical indicator may be an optical window that may enable a user to view within the base. The optical window may be formed of a transparent and/or translucent material. Alternatively, the optical window may be an opening without any material therein. The optical window may enable a user to directly view the vessel within the base. The vessels within the base may be formed of a transparent and/or translucent material, which may enable a user to see if a sample has reached the vessels of the base. For example, if blood is transported along a channel to a vessel, the vessel may visually indicate the presence of blood therein. In other embodiments, the optical indicator may include other features that may indicate that the vessel has been filled. For example, one or more sensors may be provided within the base or vessel that can determine whether a sufficient amount of sample has been provided within the vessel. The one or more sensors may provide a signal to an optical indicator on the base that may indicate whether a sample has been provided to the vessel and/or the amount of sample that has been provided to the vessel. For example, the optical sensor may include a display, such as, but not limited to, an LCD display, a light display (e.g., an LED display), a plasma screen display, which may provide an indication that the vessel has been sufficiently filled. In alternative embodiments, an optical indicator need not be provided, but an alternative indicator may be provided, such as, but not limited to, an audio indicator or temperature controlled indicator that may be used to indicate when the vessel has been filled.

Fig. 2A-2C provide views of the sample collection device 200 without the cap 110. The sample collection device 200 can include a body 220, a holder 230, and a base 240. The body may be connected to the bracket. In the present embodiment, the base 240 may be connected to the bracket at an end opposite to an end connected to the body. The body may support and/or contain at least a portion of one, two, or more channels 222a, 222 b. The channels may be capable of receiving samples 224a, 224b from a sample receiving end 226 of the device.

The body 220 may have a hollow portion 225 therein. Alternatively, the body may be formed from a solid piece. The channels 222a, 222b may be integrally formed into the body. For example, they may be passages through a solid portion of the body. The vias may be drilled through or formed using photolithographic techniques. Alternatively, the channel may be a separate structure that may be supported by the body. For example, the channel may be formed by one or more tubes that may be supported by the body. In some cases, the channels may be held in place at certain solid portions of the body and may pass through one or more hollow portions of the body. Alternatively, the body 220 may be formed of two pieces joined together to define channels 222a and 222b therein.

Channels 222a, 222b may include one or more features or characteristics mentioned elsewhere herein. At least a portion of the channels may be substantially parallel to each other. Alternatively, the channels may be angled with respect to each other. In some embodiments, the channel can have a first end that can be located at the sample receiving end 226 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, the end of each channel may be provided at the sample receiving end of the sample receiving device. One, two, or more channels may have a first end located at the sample receiving end of the sample collection device. Separate channels may be used to minimize the risk of cross-contamination of blood between one channel and another. Alternatively, the channel may have an inverted Y-shaped configuration, wherein the channel starts at a common channel and splits into two or more separate channels. Such a Y-shaped configuration may be useful in situations where contamination is not an issue. Alternatively, an alternative approach to a Y-shaped configuration would be a straight channel, and the sample collection vessels moved to sequentially 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 in close proximity to each other. The ends of the channel at the sample receiving end may be adjacent to each other. The ends of the channels at the sample receiving end may contact each other, or may be within about 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, 15mm, or 20mm of each other edge to edge or center to center. The channels may diverge from one another from the sample receiving end. For example, the other ends of the channels opposite the ends of the channels at the sample receiving end may be further away from each other. They may be spaced from each other edge-to-edge or center-to-center by greater than or equal to about 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, 15mm, 20mm, 25mm, or 30 mm.

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. Each side of the body may be gathered at the sample receiving end. The tapered portion and/or the sample receiving end may be curved. Alternatively, an edge may be provided. The surface of the tapered portion may be provided at any angle relative to the longitudinal axis of the device. For example, the tapered portion may be about 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degrees relative to the longitudinal axis.

The sample receiving end 226 of the device can contact the sample. The sample may be provided directly from the subject. The sample receiving end may contact the subject or be contacting the subject or be exuding sample from the subject. For example, the sample receiving end may contact a drop of blood on the subject's finger. The blood may enter the channel. The blood may be transported through the channel via capillary action, pressure differential, gravity, or any other motive force. The blood may pass from the sample receiving end through the channel to the sample delivery end. The sample delivery end may be in fluid communication with one or more vessels housed within the base of the device or may be brought into fluid communication with said vessels. The sample may be transferred from the channel to the vessel. The sample may be driven into the vessel via a pressure differential, capillary action, gravity, friction, and/or any other motive force. Alternatively, the sample may also be blood introduced with a pipette, syringe, or the like. It should be understood that while fig. 2B shows sample B only partially filling channels 222a, 222B, in most embodiments, the channels will be completely filled by sample B when the filling process is complete.

Fig. 3A-3B illustrate an example of the sample collection device 300 prior to bringing the channels 322a, 322B into fluid communication with one or more vessels 346a, 346B housed within the base 340 of the device. The sample collection device may include a cap 310, a body 320, a holder 330, and a base 340. The body and/or the support may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 320 and/or the holder 330 may support one or more channels 322a, 322b in the sample collection device. In one example, two channels are provided, but the description with respect to the two-channel embodiment may also apply to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels. Each channel may have a first end 323a, 323b, which may be provided at the sample receiving end 326 of the device. The first end of each channel may be open. The channels may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid may be drawn into the channel. Blood may be drawn via capillary action or any other technique described elsewhere herein. The blood may travel along the length of the channel to the respective second ends 325a, 325b of the channel. The channels may be fluidly isolated from each other. For example, fluid may enter first passage 322a via first end 323a, traverse the length of the passage, and exit the first passage at second end 325 a. Similarly, fluid may enter second channel 322b via first end 323b, traverse the length of the channel, and exit the second channel at second end 325 b. The first and second channels may be fluidly isolated such that fluid from the first channel does not pass into the second channel, and vice versa. In some embodiments, the fluid may pass to the second end of the channel without first exiting.

The channels 322a, 322b may have a diverging configuration. For example, the first ends 323a, 323b of the channels may be closer to each other than the second ends 325a, 325b of the channels. More space may be provided between the second ends of the channels than between the first ends of the channels. The first ends of the channels may or may not contact each other. The first ends of the channels may be adjacent to each other.

The base 340 may be connected to the support 330 of the sample collection device. The base 340 may or may not directly contact the support. The base may be movable relative to the support during use of the device. In some embodiments, the base is longitudinally slidable relative to the support. In some cases, the base may slide longitudinally relative to the bracket without rotating. In some cases, the base may slide coaxially with the support without rotating. In some cases, the base may rotate while moving relative to the support. A portion of the base may fit within a portion of the support, or vice versa. For example, a portion of the base may be insertable into a portion of the cradle, and/or a portion of the cradle may be insertable into the base. One or more stop features may be provided in the base and/or frame to provide a controlled degree of movement between the base and the support. The spacing features may include shelves, projections or grooves.

The base 340 may be capable of supporting one or more vessels 346a, 346 b. The base may have an outer shell that may at least partially enclose one or more vessels. In some cases, the vessel may be completely enclosed when the base is engaged with the rack 330. The base may have one or more depressions, protrusions, grooves, or shaped features to accept the vessel. The base may be formed to have a shape complementary to the shape of the vessel. The vessel may be held in an upright position relative to the base.

The same number of vessels as the number of channels may be provided. For example, if N channels are provided, N vessels may be provided, where N is a positive integer (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a respective vessel. In one example, a sample collection device may have first and second channels, and respective first and second vessels. The first channel 322a may be in fluid communication with the first vessel 346a or may be configured to be brought into fluid communication with the first vessel 346a, and the second channel 322b may be in fluid communication with the second vessel 346b or may be configured to be brought into fluid communication with the second vessel 346 b.

In some embodiments, each vessel may have a body 349a, 349b and a cap 348a, 348 b. In some cases, the vessel body may be formed of a transparent or translucent material. The vessel body may allow a sample provided within the vessel body to be visible when viewed from outside the vessel. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may comprise an open end and a closed end. The open end may be a top end of the vessel, which may be located at an end of the vessel closer to the one or more channels. The closed end may be a bottom end of the vessel, which may be located at an end of the vessel further from the one or more channels. Various embodiments of the vessel may be described in more detail elsewhere herein.

The base 340 may have one or more optical indicators, such as optical windows 342a, 342 b. An optical window may be positioned over the vessels 346a, 346 b. In some cases, the optical window may be positioned over the vessel body. A single window may provide viewing of a single vessel or of multiple vessels. In one example, the same number of optical windows as the vessels may be provided. Each optical window may correspond to a respective vessel. Both the optical window and the vessel may be formed of a light transmissive material that may allow a user to observe from outside the sample collection device whether a sample has reached the vessel.

In some embodiments, there may be optical windows for channels 322a and 322b so that a user can observe when a desired fill level has been reached in the channels. In some embodiments where the body 320 is completely transparent or translucent, there may be markers or indicator markings along the channel to mark when the desired fill level is reached.

The vessel may be sized to contain a small fluid sample. In some embodiments, the vessel can be configured to hold no more than about 5mL, 4mL, 3mL, 2mL, 1.5mL, 1mL, 900uL, 800uL, 700uL, 600uL, 500uL, 400uL, 300uL, 250uL, 200uL, 150uL, 100uL, 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL, or 1 nL. The vessel may be configured to hold no more than a few drops of blood, a drop of blood, or a portion of no more than a drop of blood.

The vessel may include caps 348a, 348 b. The plug may be configured to fit over the open end of the vessel. The cap may block the open end of the vessel. The cap may fluidly seal the vessel. The cap may form a fluid-tight seal with the vessel body. For example, the cap may be gas and/or liquid impermeable. Alternatively, the cap may allow certain gases and/or liquids to pass through. In some cases, the cap may be breathable and liquid impermeable. The cap may be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit into a portion of the vessel body. The cap may form a stopper with the vessel body. The cap may include a flange or shelf that may be shrouded over a portion of the vessel body. The flange or shelf prevents the cap from sliding into the vessel body. In some cases, a portion of the cap may overlie the top and/or sides of the vessel body. Any description herein of vessels may be applicable in combination with a sample collection device. Optionally, some embodiments may include additional components in the vessel assembly, such as a cap holder. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and the vessel. In one embodiment, the cap retainer engages an attachment, flange, recess, or other attachment location on the exterior of the vessel to hold the cap in place. Alternatively, some embodiments may combine the functionality of both the cap and the cap holder into one assembly.

One or more engagement assemblies may be provided. The engagement assembly may include a channel retainer 350 and/or a force application component, such as a spring 352 or rubber band. In one embodiment, the retainer 350 may hold the adapter channel 354 fixed to the bracket. As will be described elsewhere herein, the adapter channel 354 may be integrally formed with the collection channel, or may be a separate element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 350 may prevent the adapter channel 354 from sliding relative to the bracket. The retainer 350 may optionally provide a cradle on which a force applying component, such as a spring, may reside.

In one example, the engagement assemblies may each include a spring 352, and the spring 352 may apply a force such that when the spring is in its natural state, the base 340 is in an extended state. When the base is in its extended state, a space may be provided between the vessels 346a, 346b and the engagement assembly. In some cases, the second end of the channel may or may not contact the cap of the vessel when the base 340 is in its extended state. The second ends of the channels 325a, 325b may be in a position where they are not in fluid communication with the interior of the vessel.

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

In one embodiment, the engagement assembly may receive an adapter channel 354, such as but not limited to an elongated member having angled, tapered, or sharpened ends 327a and 327 b. It should be understood that in some embodiments, the ends 327a and 327b are part of a needle that is formed separately from the channels 322a and 322b and is in turn coupled to the channels 322a and 322 b. The needle may be formed of the same or different material from the body defining the channels 322a and 322 b. For example, some embodiments may use metal to form the needles, while using a polymer or plastic material for the bodies defining the channels 322a and 322 b. Alternatively, some embodiments may form ends 327a and 327b on a component that is integrally formed with channels 322a and 322 b. In some cases, the second end of the channel may be configured to penetrate a material, such as a cap 348a, 348b of a vessel. In some embodiments, a portion of the adapter channel 354 may be insertable within the collection channel, or a portion of the collection channel may be insertable within the adapter channel, or both may be configured for flush alignment. Alternatively, some embodiments may have the adaptor channel 354 integrally formed with the collection channel 322 a. It should be understood that fig. 3B (and fig. 4B) shows sample B only partially filling channels 122a, 122B, but in most embodiments, the channels will be completely filled by sample B when the filling process is complete. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Fig. 4A-4B illustrate an example of a sample collection device 400 having channels 422a, 422B, the channels 422a, 422B being in fluid communication with the interior of vessels 446a, 446B within the device. The sample collection device may include a cap 410, a body 420, a holder 430, and a base 440. The body and/or the support may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 420 and/or the support 430 may support one or more channels 422a, 422b in the sample collection apparatus. For example, a first channel and a second channel may be provided. Each channel may have a first end 423a, 423b, which first end 423a, 423b may be provided at the sample receiving end 426 of the device. The first end of each channel may be open. The channels may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid may be drawn into the channel. The fluid may be drawn in via capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second ends 425a, 425b of the channel. In some embodiments, the fluid may reach the second end of the channel via capillary action or other techniques described herein. In other embodiments, the fluid need not reach the second end of the channel. The channels may be fluidly isolated from each other.

In some embodiments, when the channel is not in fluid communication with the interior of the vessels 446a, 446b, the fluid may pass to the second end of the channel without exiting. For example, fluid may be drawn into the channel via capillary action, which may cause the fluid to flow toward or near the end of the channel without causing the fluid to exit the channel.

The base 440 may be connected to the support 430 of the sample collection device. The base may be movable relative to the support during use of the device. In some embodiments, the base is longitudinally slidable relative to the support. In one example, the base may have (i) an extended position in which the channel is not in fluid communication with the interior of the vessel, and (ii) a compressed position in which the channel is in fluid communication with the interior of the vessel. The sample collection device may be initially provided in an extended state, as shown in fig. 3. After the sample has been collected and flows through the length of the channel, the user can push into the base to provide the sample collection device in its compressed state, as shown in fig. 4. Once the base has been pushed in, the base may naturally remain pushed in, or may spring back to an extended state once the pushing force is removed. In some cases, the base may be pulled out to an extended state, or may be pulled out completely to provide access to the vessels therein.

The base 440 may be capable of supporting one or more vessels 446a, 446 b. The base may have an outer shell that may at least partially enclose the one or more vessels. In some cases, the vessel may be completely enclosed when the base is engaged with the rack 430. The base may have one or more depressions, protrusions, grooves, or shaped features to accept the vessel. The base may be formed to have a shape complementary to the shape of the vessel. The vessel may be held in an upright position relative to the base.

The same number of vessels as the number of channels may be provided. Each channel may correspond to a respective vessel. In one example, a sample collection device may have first and second channels, and respective first and second vessels. The first channel 422a may be in fluid communication with or may be configured to be brought into fluid communication with a first vessel 446a, and the second channel 422b may be in fluid communication with or may be configured to be brought into fluid communication with a second vessel 446 b. The first channel may not initially be in fluid communication with the first vessel, and the second channel may not initially be in fluid communication with the second vessel. The first and second channels may be brought into fluid communication with the interior of the first and second vessels, respectively, when the base is pushed in relative to the rack. The first and second channels may be brought into fluid communication with the first and second vessels simultaneously. Alternatively, they need not be brought into fluid communication simultaneously. 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 vessel may have a body 449a, 449b and a cap 448a, 448 b. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may comprise an open end and a closed end. The open end may be a top end of the vessel, which may be located at an end of the vessel closer to the one or more channels. The closed end may be a bottom end of the vessel, which may be located at an end of the vessel further from the one or more channels.

The base 440 may have one or more optical indicators, such as optical windows 442a, 442 b. Optical windows may be positioned over the vessels 446a, 446 b. In some cases, the optical window may be positioned over the vessel body. Both the optical window and the vessel may be formed of a light transmissive material that may allow a user to observe from outside the sample collection device whether a sample has reached the vessel. In some embodiments, the vessel may contain a marker on the vessel itself to indicate the fill level requirement.

The vessel may comprise caps 448a, 448 b. The cap may be configured to fit over the open end of the vessel. The cap may block the open end of the vessel. The cap may fluidly seal the vessel. The cap may form a fluid-tight seal with the vessel body. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit into a portion of the vessel body. The cap may include a flange or shelf that may be shrouded over a portion of the vessel body. In some embodiments, the cap may have a hollow or dimple. The hollow or dimple can help guide the second end of the channel to the center of the cap. In some cases, the second ends of the channels 425a, 425b may be located above the cap of the vessel when the sample collection device is in the extended state. The second end of the channel may or may not contact the vessel cap. In some cases, the second end of the channel may be placed within a hollow or recess of the cap. In some cases, the second end of the channel may partially penetrate the cap without reaching the interior of the vessel. Optionally, some embodiments of the cap may include a roll clamp to maintain the vacuum.

The second end of the channel may have angled, tapered or pointed ends 427a and 427 b. It should be understood that in some embodiments, the ends 427a and 427b are part of needles that are formed separately from the channels 422a and 422b and then coupled to the channels 422a and 422 b. The needle may be formed of the same or different material from the body defining the channels 422a and 422 b. For example, some embodiments may use metal to form the needles, while using a polymer or plastic material for the body defining the channels 422a and 422 b. Alternatively, some embodiments may form ends 427a and 427b on a component that is integrally formed with channels 422a and 422 b. In some cases, the second end of the channel may be configured to penetrate a material, such as the cap 448a, 448b of the vessel. The cap may be formed of a material that prevents the sample from passing therethrough in the absence of a penetrating member. The cap may be formed from a single solid piece. Alternatively, the cap may include a slit, opening, hole, thin portion, or any other feature that may accept a penetrating member. The slit or other opening may be capable of retaining a sample therein when the penetrating member is not in the slit or opening, or when the penetrating member is removed from the slit or opening. In some cases, the cap may be formed of a self-healing material such that when the penetrating member is removed, the opening formed by the penetrating member closes. The second end of the channel may be a penetrating member that may pass through the cap and into the interior of the bowl. In some embodiments, it will be appreciated that the penetration member may be a hollow needle that allows the sample to pass through, rather than just a needle for puncturing. In some embodiments, the piercing tip may be a non-coring design, such as but not limited to a tapered cannula that pierces without coring the cap material.

One or more engagement assemblies may be provided. The engagement assembly may include a channel retainer 450 and/or a force application component, such as a spring 452 or rubber band. In one embodiment, the retainer 450 may hold the adapter channel 454 fixed to the bracket. As will be described elsewhere herein, the adaptor channel 454 may be integrally formed with the collection channel, or may be a separate element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 450 may prevent the adaptor channel 454 from sliding relative to the bracket. The retainer 450 may optionally provide a cradle on which a force applying assembly, such as a spring, may reside.

In one example, the engagement assembly can include a spring 452 that can exert a force such that when the spring is in its natural state, the base is in its extended state. When the base is in its extended state, space may be provided between the vessels 446a, 446b and the engagement assemblies. The second ends of the channels 425a, 425b may be in a position where they are not in fluid communication with the interior of the vessel.

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

When pressed into the base, the spring 452 may be compressed. The second ends 425a, 425b of the channels may penetrate the cap of the vessel. The second end of the channel may access the interior of the vessel. In some cases, a force may be provided to drive fluid from the channel into the vessel. For example, a pressure differential may be generated between the first and second ends of the channel. A positive pressure may be provided at the first ends 423a, 423b of the channels and/or a negative pressure may be provided at the second ends of the channels. The positive pressure may be positive relative to the pressure at the second end of the channel and/or the ambient air. The negative pressure may be negative with respect to the pressure at the first end of the channel and/or the ambient air. In one example, the vessel may have a vacuum therein. When the second end of the channel penetrates the vessel, the negative pressure within the vessel may pull the sample into the vessel. In alternative embodiments, the sample may be driven into the vessel by capillary force, gravity, or any other motive force. In an embodiment, the vessel does not have a vacuum therein. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In some cases, different types of motive forces may be used at different stages of sample collection. Thus, one type of motive force may be used to draw a sample into the channel, and then a different type of motive force may be used to move the sample from the channel into the vessel. For example, capillary forces may draw a sample into the channel, while pressure differentials may drive the sample from the channel into the vessel. Any combination of power may be used to draw the sample into the channel and into the vessel. In some embodiments, the one or more motive forces for aspirating the sample into the channel are different from the one or more motive forces for aspirating the sample into the vessel. In some alternative embodiments, the one or more powers may be the same for each stage. In some embodiments, the one or more motive forces are applied sequentially or over a defined period of time. By way of non-limiting example, one or more motive forces to draw sample into the vessel are not applied until at least one channel has reached a minimum fill level. Optionally, the one or more motive forces to draw the sample into the vessel are not applied until at least two channels have each reached a minimum fill level for that channel. Optionally, one or more motive forces to draw sample into the vessel are not applied until all channels have each reached a minimum fill level for that channel. In some embodiments, one or more power is applied simultaneously.

Some embodiments may use a pressurized gas source coupled to the sample collection device and configured to push collected bodily fluids from one or more channels into their respective vessels. Alternatively, some embodiments may use a vacuum source not associated with the vessel to pull the sample fluid toward the vessel.

Furthermore, some embodiments of the channel may be configured such that there is sufficient capillary force within the channel such that, once filled, the force is greater than gravity such that the sample does not escape from the channel based solely on gravity. Additional motive force is used to break the capillary hold of one or more channels. Optionally, as described elsewhere herein, a device such as, but not limited to, a sleeve may contain bodily fluids to prevent them from exiting the channel at the end closest to the vessel, thereby minimizing any loss until transfer to the vessel begins.

Alternatively, other materials such as, but not limited to, lyosphere (lyosphere), sponge or other power provider, etc., may be used to provide the motive force for aspirating the sample into the vessel. When multiple forces are used, this may be a primary, secondary or tertiary motive force to draw the sample into the vessel. Optionally, some embodiments may include a push-type power provider, such as, but not limited to, a plunger, to move the sample in a desired manner.

After the sample has been introduced into the channel, some time may elapse for the sample to travel along the length of the channel. A user may introduce a sample into the sample collection apparatus and may wait for the sample to travel along the length of the channel. One or more optical indicators may be provided that may indicate whether the sample has reached a desired fill level, such as but not limited to reaching the end of the channel. In other embodiments, the user may wait a predetermined amount of time before pushing into the base. The base may be pushed in after the user has determined that the sample has traveled a sufficient length of the channel and/or a sufficient amount of time has elapsed since the sample was introduced. After pushing in the base, the channel may be brought into fluid communication with the vessel, and the sample may flow from the channel into the vessel. An optical indicator may be provided so that the user can know when the vessel is filled.

Once the vessel has been filled, it may be transferred to a desired location using the systems and methods described elsewhere herein. In some cases, the entire sample collection device may be transferred. A cap may be placed over the sample collection device for transfer. In other embodiments, the base portion and/or the stand portion may be removable from the rest of the device. In one example, the base may be removed from the sample collection device and the vessel may be transferred along with the base. Alternatively, the base may be removed from the sample collection device to provide access to the vessel, and the vessel may be removed from the device and transported. Removal of the base may involve some disassembly of the sample collection device in order to remove the base. This may involve the use of sufficient force to overcome a stop or stop built into the device to prevent accidental disengagement. Optionally, some other positive action may be taken by the user prior to removal of the base, such as, but not limited to, disengaging a latch or other locking mechanism. Optionally, some embodiments may allow removal of the vessel without removal of the base, but allow access to the vessel by way of an opening, access port, or openable cover on the base.

In some embodiments, one or more of the channels and/or vessels may include features described elsewhere herein, such as separation members, coatings, anticoagulants, beads, or any other features. In one example, the sample introduced to the sample collection device can be whole blood. Two channels and corresponding vessels may be provided. In this non-limiting example, each channel has a coating, such as, but not limited to, an anticoagulant coating in the channel. Such anticoagulant coatings may perform one or more of the following functions. First, anticoagulants can prevent whole blood from clotting within the channel during the sample collection process. Depending on the amount of whole blood to be collected, clotting may prematurely block the channel before a sufficient amount of blood has been brought into the channel. Another function is to introduce an anticoagulant into the whole blood sample. By having anticoagulant in the channel, the process may begin earlier in the collection process than some embodiments that may have anticoagulant only in vessels 446a or 446 b. Such early introduction of anticoagulant may also be advantageous in cases where the whole blood sample is to be directed along a pathway that may have portions that are not coated with anticoagulant, such as, but not limited to, the interior surface of a needle connected to channel 422a or 422 b. Alternatively, some embodiments may include surfactants that may be used to modify the contact angle (wettability) of a surface.

In some embodiments, the interior surfaces of the channel and/or other surfaces along the fluid pathway, such as but not limited to the sample inlet to the interior of the sample collection vessel, may be coated with a surfactant and/or anticoagulant solution. The surfactant provides a wettable surface for the hydrophobic layer of the fluidic device and facilitates filling of the metering channel with a liquid sample, such as blood. The anticoagulant solution helps prevent coagulation of a sample, such as blood, when provided to the fluidic device. Exemplary surfactants that may be used include, but are not limited to, Tween @,Sodium deoxycholate, Triton,Pluronic and/or other non-hemolytic detergents that provide the appropriate wetting characteristics of the surfactant. EDTA and heparin are non-limiting anticoagulants that may be used. In one non-limiting example, the solution in an embodiment comprises 2% Tween, 25mg/mL EDTA in 50% methanol/50% H2O, which is then air dried. The methanol/water mixture provides a means to solubilize EDTA and Tween and also dries quickly from the surface of the plastic. The solution may be applied to the channel or other surface along the fluid flow path by any technique that will ensure a uniform film is coated on the surface (e.g., pipetting, spraying, printing, or wicking).

It should also be understood that for any of the embodiments herein, the coating in the channel may extend along the entire path of the channel. Alternatively, the coating may cover most, but not all, of the channel. Optionally, some embodiments may not cover channels in the area closest to the access opening to minimize the risk of cross-contamination, wherein coating material from one channel migrates into nearby channels by means of all channels being in simultaneous contact with the target sample fluid and thus having a communicating fluid pathway.

Although embodiments herein have been shown with two separate channels located in a sample collection device, it should be understood that some embodiments may use more than two separate channels. Alternatively, some embodiments may use less than two completely separate channels. Some embodiments may use only one separate channel. Alternatively, some embodiments may use an inverted Y-shaped channel that initially starts as one channel and then splits into two or more channels. Any of these concepts may be adapted for use with the other embodiments described herein.

Collecting device with self-supporting collecting channel

Fig. 5A-5B provide another example of a sample collection device 500 provided according to embodiments described herein. The sample collection device can include a collection device body 520, a holder 530, and a base 540. In some cases, a cap may optionally be provided. The collection device body may comprise one or more collection channels 522a, 522b defined by a collection tube that may be capable of receiving a sample. The base may have one or more optical indicators 542a, 542b that may provide a visual indication of whether the sample has reached one or more vessels housed in the base. The rack may have one or more optical indicators 532a, 532b that may provide a visual indication of whether the sample has reached or passed through a portion of the channel.

The collection device body 520 of the sample collection device can include at least a portion of one or more tubes having channels 522a, 522b therein. Optionally, the device collection body 520 may also define channels coupled to the channels 522a, 522b defined by the tubes. In some embodiments, a portion of the channel may extend beyond the collection device body. The channel may extend beyond one or both ends of the collection device body.

The collection device body 520 may be connected to a bracket 530. The stent may contain a portion of one or more channels therein. The collection device body may be permanently fixed to the stand or may be removable with respect to the stand. In some cases, the collection device body and the bracket may be formed from a single, unitary piece. Alternatively, the collection device body and the holder may be formed of separate pieces.

During 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 may be insertable within the stent 530, and/or a portion of the stent may be insertable within the body. The body may be movable relative to the support. In some cases, a sample collection device can have a longitudinal axis that extends along the length of the sample collection device. The body and/or the support are movable relative to each other in the direction of said longitudinal axis. The body and/or the support may be capable of moving a limited distance relative to each other. The body and/or the support may move coaxially without rotational movement. Alternatively, a rotational movement may be provided.

The collection device body 520 may be formed of a light transmissive material. For example, the collection device body may be formed of a transparent or translucent material. Alternatively, the body may be formed of an opaque material. The support 530 may be formed of an optically opaque, translucent, or transparent material. The holder may or may not have the same optical properties as the collection device body. The holder may be formed of a different material from the collecting device body, or formed of the same material as the collecting device body. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The collection device body, holder, and/or base can have any shape or size. In some examples, the collection device body, the stand, and/or the base can have a circular, oval, triangular, quadrilateral (e.g., square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may remain the same or may vary along the length. The cross-sectional shape may be the same or may vary for the body, support and/or base. In some cases, the collection device body, holder, and/or base can have less than or equal to about 10cm²、7cm²、5cm²、4cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.8cm²、0.5cm²、0.3cm²Or 0.1cm²Cross-sectional area of (a). The cross-sectional area may vary or may remain the same along the length. The cross-sectional size may be the same or may vary for the collection body, holder and base. The collection device body, support, and/or base can have a length of less than or equal to about 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.5cm, or 0.1 cm. The collection device body may have a greater or lesser length than the holder or base, or a length equal to the holder or base.

The channels 522a, 522b may be supported by the device body 520 and/or the bracket 530. In some cases, the entire length of the tube or channel therein may be contained within the device body and stent combination. Alternatively, the channel may extend beyond the device body and/or the stent, as seen in fig. 5. In some cases, the channel may extend beyond one end of the device body/stent combination, or beyond both ends. In some cases, a portion of the channel can be within the device body, and a portion of the channel can be within the cradle. The position of the channel may be fixed by the device body and/or the holder. In some cases, the channel may be fixed to the device body and/or not move relative to the device body. The channel may be movable relative to the support. In some cases, multiple channels may be provided. At least a portion of the channels may be substantially parallel to each other. The channels may be parallel to each other and/or a longitudinal axis extending along the length of the sample collection device. Alternatively, no portion of the channels need be parallel to each other. In some cases, at least a portion of the channels are not parallel to each other. The channel may be slightly curved. Alternatively, they may be straight, but aligned closer to each other as they approach the sample collection point. It should be understood that the tubes defining the channels 522a and 522b may be made of an optically transparent material, transmissive material, or other material sufficient to provide a detectable change in the sample that has reached a desired fill level in at least one of the channels. Alternatively, the detectable change may be used to detect when both channels have at least reached a desired fill level.

A base 540 may be provided within the sample collection device. The base may be connected to a support 530. In some cases, a portion of the base 540 may be insertable within the stent 530, and/or a portion of the stent may be insertable within the base. The base may be fixed relative to the support or may be movable relative to the support. The base may be provided at an end of the bracket opposite to an end of the bracket connected to the body. The base may be formed as a separate piece from the support. The base may be detachable from the support. Alternatively, the base may be fixed to the bracket and/or formed as a unitary piece with the bracket.

The base 540 may receive one or more vessels therein. The vessel may be in fluid communication with the channel and/or may be brought into fluid communication with the channel. One end of the channel may be within the vessel or may be brought into the vessel. The base may have one or more optical indicators 542a, 542b that may provide a visual indication of whether the sample has reached one or more vessels housed in the base. In some implementations, the optical indicator can be an optical window that can enable a user to view into the base. The optical window may be formed of a transparent and/or translucent material. Alternatively, the optical window may be an opening without any material therein. The optical window may enable a user to directly view the vessel within the base. The vessels within the base may be formed of a transparent and/or translucent material, which may enable a user to see if a sample has reached the vessels of the base. For example, if blood is transported along a channel to a vessel, the vessel may show the blood therein. In other embodiments, the optical indicator may include other features that may indicate that the vessel has been filled. For example, one or more sensors may be provided within the base or vessel that can determine whether a sufficient amount of sample has been provided within the vessel. The sensor may provide a signal to an optical indicator on the base that may indicate whether a sample has been provided to the vessel and/or the amount of sample that has been provided to the vessel. For example, the optical sensor may include a display, such as an LCD display, a light display (e.g., an LED display), a plasma screen display, which may provide an indication that the vessel has been sufficiently filled. In alternative embodiments, an optical indicator need not be provided, but alternative indicators may be provided, such as, but not limited to, an audio indicator, temperature-controlled indicator, or other device that may indicate when a vessel has been filled by a detectable signal (such as a signal detectable by a user).

The rack 530 may have one or more optical indicators 532a, 532b that may provide a visual indication of whether a sample has reached or passed through a portion of the channel housed by the rack. In some embodiments, the optical indicator may be an optical window that may enable a user to look into the cradle. The optical window may be formed of a transparent and/or translucent material. Alternatively, the optical window may be an opening without any material therein. The optical window may enable a user to directly view a portion of the channel within the holder. The channel may be formed of a transparent and/or translucent material, which may enable a user to see if a sample has reached the portion of the channel below the optical window. In other embodiments, the optical indicator may include other features that may indicate that the sample has passed through a portion of the channel, such as the sensors described elsewhere herein.

Referring now to fig. 6A-6B, additional views of a sample collection device 500 are provided according to one embodiment described herein.

In some embodiments, a portion of the tube containing the channels 522a, 522b can extend beyond the collection device body 520. The portion of the channel that extends out can include a portion of the channel that is configured to receive a sample from a subject. In one example, the channel may have a first end 523a, 523b, which may be the sample receiving end of the channel.

The channel may optionally be defined by a rigid material. Alternatively, the channel may be defined by a flexible material, or may have a flexible component. The channel may or may not be designed to bend or curve. The channels may or may not be substantially parallel to each other. In some cases, the first ends of the channels may be spaced apart when in a relaxed state. The first ends of the channels may be maintained at the distance during operation of the device. Alternatively, the first ends of the channels may be brought closer together. For example, the first ends of the channels may be squeezed together. Each open end of the channel can receive a sample individually. The samples may be received sequentially. The samples may be from the same subject. Alternatively, the channels may be capable of receiving the same sample simultaneously.

The channels 522a, 522b may include one or more features or characteristics mentioned elsewhere herein. At least a portion of the channels may be substantially parallel to each other. Alternatively, the channels may be angled with respect to each other. In some embodiments, the channel can have a first end that can be located at the sample receiving end 526 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, the end of each channel may be provided at a sample receiving end of a sample receiving device. One, two, or more channels may have a first end located at the sample receiving end of the sample collection device.

In some embodiments, the device body 520 may be movable relative to the support 530. A portion of the device body may be insertable within the holder, or vice versa. In one example, the device body may have a flange 527 and an interior portion 529. The flange may have a larger cross-sectional area than the inner portion. The inner portion may be capable of being inserted into the stent. The flange may act as a stop to prevent the entire body from being inserted into the bracket. The flange may be located on a shoulder of the bracket.

Fig. 7A-7B illustrate partial cross-sectional views of examples of sample collection devices 700 provided according to embodiments described herein. The sample collection device is in an extended state prior to bringing the channels 722a, 722b into fluid communication with one or more vessels 746a, 746b housed within the base 740 of the device. The sample collection device may include a body 720, a holder 730, and a base 740. The body and/or the support may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the body 720 and/or the holder 730 may support one or more channels 722a, 722b in the sample collection device. In one example, two channels are provided, but the description with respect to the two-channel embodiment may also apply to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels. Each channel can have a first end 723a, 723b, which can be the sample receiving end of the device. The first end of each channel may be open. The channels may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid may be drawn into the channel. The fluid may be drawn in via capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second end of the channel. The channels may be fluidly isolated from each other. For example, fluid may enter the first channel 722a via the first end 723a, traverse the length of the channel, and exit the first channel at the second end. Similarly, fluid may enter the second channel 722b via the first end 723b, traverse the length of the channel, and exit the second channel at the second end. The first and second channels may be fluidly isolated such that fluid from the first channel does not pass into the second channel, and vice versa. In some embodiments, the fluid may pass to the second end of the channel without first exiting.

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

The holder 730 may have one or more optical indicators, such as optical windows 732a, 732 b. Optical windows may be positioned over channels 722a, 722 b. In some cases, the optical window may be positioned over a portion of the channel. A single window may provide viewing of a single channel portion or of multiple channel portions. In one example, the same number of optical windows as channels may be provided. Each optical window may correspond to a respective channel. Both the optical window and the channel can be formed of a light transmissive material that can allow a user to observe from outside the sample collection device whether the sample has reached and/or passed through the underlying channel portion. Such a determination may be used to determine when to compress the sample collection device.

The base 740 may be connected to the holder 730 of the sample collection device. The base may or may not be in direct contact with the support. The base may be fixed relative to the support during use of the device. In some cases, the base may be removable from the stand. A portion of the base may be insertable into the holder and/or vice versa. In some embodiments, the base is slidable out of the bracket in a longitudinal direction relative to the bracket. In some cases, the base may slide coaxially with the support without rotating. In some cases, the base may rotate while moving relative to the support.

The base 740 may be capable of supporting one or more vessels 746a, 746 b. The base may have an outer shell that may at least partially enclose the one or more vessels. In some cases, the vessel may be completely enclosed when the base is engaged with the stand 730. The height of the base may extend beyond the height of the vessel. Alternatively, the height of the base may extend to the same extent as or less than the height of the vessel. The base may have one or more depressions, protrusions, grooves, or shaped features to accept the vessel. The base may be formed to have a shape complementary to the shape of the vessel. For example, the base may have one or more tubular recesses into which the tubular vessel may fit snugly. The vessel may be friction fit into the base. The vessel may be held in an upright position relative to the base. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The same number of vessels as the number of channels may be provided. For example, if N channels are provided, N vessels may be provided, where N is a positive integer (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a respective vessel. In one example, a sample collection device may have first and second channels, and respective first and second vessels. The first channel 722a may be in fluid communication with or may be configured to be brought into fluid communication with a first vessel 746a, and the second channel 722b may be in fluid communication with or may be configured to be brought into fluid communication with a second vessel 746 b.

In some embodiments, each vessel may have a body 749a, 749b and a cap 748a, 748 b. The vessel may have any feature or characteristic as described elsewhere herein.

The base 740 may have one or more optical indicators, such as optical windows 742a, 742 b. The optical window may be positioned above the vessels 746a, 746 b. In some cases, the optical window may be positioned over the vessel body. A single window may provide viewing of a single vessel or of multiple vessels. In one example, the same number of optical windows as the vessels may be provided. Each optical window may correspond to a respective vessel. Both the optical window and the vessel may be formed of light transmissive materials that may allow a user to observe from outside the sample collection device whether a sample has reached the vessel. Such visual assessment may be used to determine when a sample reaches the vessel, and when the base may be removed from the sample collection device.

One or more engagement assemblies may be provided. The engagement assembly may include a channel retainer 750 and/or a force application component, such as a spring 752 or a rubber band. In one embodiment, retainer 750 may hold adapter passage 754 in place fixed to the bracket. As will be described elsewhere herein, the adapter channel 754 may be integrally formed with the collection channel or may be a separate element that may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 750 may prevent the adapter channel 754 from sliding relative to the bracket. The retainer 750 may optionally provide a stand upon which a force applying component, such as a spring, may reside.

In one example, the engagement assembly can include a spring 752 that can exert a force such that when the spring is in its natural state, the body 720 is in an extended state. When the body is in its extended state, a space may be provided between the vessels 746a, 746b and the engagement assemblies. The inner portion 729 of the main body may be exposed and/or uncovered by the bracket 730 when the main body is in its extended state. In some cases, the second ends of the channels 722a, 722b may or may not contact the cap of the vessel when the body is in its extended state. The second ends of the channels may be in a position where they are not in fluid communication with the interior of the vessel. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Fig. 8A-8B provide examples of sample collection devices 800 having channels 822a, 822B in fluid communication with the interior of vessels 846a, 846B within the device. The sample collection device may include a body 820, a holder 830, and a base 840. The body and/or the support may support and/or contain at least a portion of one, two or more channels. The channel may extend beyond an end of the body. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 820 and/or the holder 830 can support one or more channels 822a, 822b in the sample collection apparatus. For example, a first channel and a second channel may be provided. Each channel may have a first end 823a, 823b that may be provided at a sample receiving end of the device that may extend beyond the body. The first end of each channel may be open. The channels may be open to ambient air. The channel may be rigid or may be flexible. In some embodiments, the channels may have a length that allows them to bend to contact each other. When the first end of the channel contacts a fluid, such as blood, the fluid may be drawn into the channel. Each channel end may individually contact a fluid, which may be drawn into the respective channel. This may involve angling the sample collection device such that only one opening in the access channel is in contact with the sample fluid at any one time. Alternatively, all channels may be simultaneously contacted with the same sample, which is simultaneously aspirated into the respective channels. Alternatively, multiple but not all channels may simultaneously contact the same sample, which is then simultaneously aspirated into the respective channels. The fluid may be drawn in via capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second end of the channel. In some embodiments, the fluid may reach the second end of the channel via capillary action or other techniques described herein. In other embodiments, the fluid need not reach the second end of the channel. The channels may be fluidly isolated from each other.

In some embodiments, when the channel is not in fluid communication with the interior of the vessels 846a, 846b, fluid may pass to the second end of the channel without exiting. For example, fluid may be drawn into the channel via capillary action, which may cause the fluid to flow toward or near the end of the channel without causing the fluid to exit the channel.

The body 820 may be movable relative to the stand 830 during use of the device. In some embodiments, the body is slidable in a longitudinal direction relative to the stent. In one example, the body may have (i) an extended position in which the channel is not in fluid communication with the interior of the vessel, and (ii) a compressed position in which the channel is in fluid communication with the interior of the vessel. The sample collection device may be initially provided in an extended state, as shown in fig. 7. After the sample has been collected and flows through the length of the channel, the user may push into the body to provide the sample collection device in its compressed state, as shown in fig. 8. In some cases, an interior portion of the body is exposed when the body is in the extended state. When the body is in a compressed state, an interior portion of the body may be covered by the stent. The flange of the body may contact the bracket. The body may naturally remain pushed in once it has been pushed in, or may spring back to an extended state once the pushing force is removed. In some cases, the body may be pulled out to an extended state, or may be pulled out completely to provide access to the vessel therein. Optionally, in some assemblies, removal of the body will not provide access to the vessel.

The base 840 may be attached to the stand 830 of the sample collection device. The base 840 may be capable of supporting one or more vessels 846a, 846 b. The base may have an outer shell that may at least partially enclose the one or more vessels. In some cases, the vessel may be completely enclosed when the base is engaged with the rack 830. The base may have one or more depressions, protrusions, grooves, or shaped features to accept the vessel. The base may be formed to have a shape complementary to the shape of the vessel. The vessel may be held in an upright position relative to the base.

The same number of vessels as the number of channels may be provided. Each channel may correspond to a respective vessel. In one example, a sample collection device may have first and second channels, and respective first and second vessels. The first channel 822a may be in fluid communication with or may be configured to be brought into fluid communication with a first vessel 846a, and the second channel 822b may be in fluid communication with or may be configured to be brought into fluid communication with a second vessel 846 b. The first channel may not initially be in fluid communication with the first vessel, and the second channel may not initially be in fluid communication with the second vessel. The first and second channels may be brought into fluid communication with the interior of the first and second vessels, respectively, when the body is pushed in relative to the cradle. The first and second channels may be brought into fluid communication with the first and second vessels simultaneously. Alternatively, they need not be brought into fluid communication simultaneously. 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 vessel can have a body 849a, 849b and a cap 848a, 848 b. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may comprise an open end and a closed end. The open end may be a top end of the vessel, which may be at an end of the vessel closer to the one or more channels. The closed end may be a bottom end of the vessel, which may be at an end of the vessel further from the one or more channels. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The bracket 830 may have one or more optical indicators, such as optical windows 832a, 832 b. Optical windows may be positioned over portions of the channels 822a, 822 b. The optical window may provide an indication of whether the sample has reached and/or passed through the portion of the channel shown by the optical window. This can be used to assess whether the sample has flowed sufficiently for the user to push the body into the sample collection apparatus. In some cases, it may be desirable for the sample to reach or near the second end of the channel before causing the channel to come into fluid communication with the vessel. In some cases, the sample may need to reach a particular portion of the channel before pushing into the body to bring the channel into fluid communication with the vessel. A particular portion of the channel may be located below the optical window.

The base 840 may have one or more optical indicators, such as optical windows 842a, 842 b. Optical windows may be positioned over the vessels 846a, 846 b. In some cases, the optical window may be positioned over the vessel body. The optical window may provide an indication of whether the sample has entered the vessel. The optical window may show how much sample has filled the vessel. This can be used to assess whether a sufficient amount of sample has entered the vessel. In some cases, it may be desirable to have a specific amount of sample enter the vessel before removing the vessel from fluid communication with the channel. A predetermined volume of sample in the vessel may be desired before removing the base of the device to bring the vessel out of fluid communication with the channel.

The vessel and/or the interface with the channel may have any characteristic or feature, such as those described elsewhere herein. In some cases, the second end of the channel may penetrate the cap of the vessel, thereby bringing the channel into fluid communication with the vessel. In some cases, the channel may be withdrawn from the vessel, and the cap of the vessel may form a fluid-tight seal, allowing a fluid-tight environment within the vessel when the channel is brought out of fluid communication with the vessel.

One or more engagement assemblies may be provided. The engagement assembly may include a channel retainer and/or a force application component, such as a spring or rubber band. The retainer may hold the channel fixed to the body. The retainer prevents the channel from sliding relative to the body. The retainer may optionally provide a cradle on which a force applying assembly, such as a spring, may reside.

In one example, the engagement assembly may include a spring that may exert a force such that the body is in its extended state when the spring is in its natural state. A space may be provided between the vessels 846a, 846b and the bottom portion of the sample body 820 when the body is in its extended state. The second ends of the channels may be in a position where they are not in fluid communication with the interior of the vessel.

When pressed into the body, the spring 852 may be compressed (see also fig. 9A-9C). The second end of the channel may penetrate the cap of the vessel. The second end of the channel may access the interior of the vessel. In some cases, a force may be provided to drive fluid from the channel into the vessel. For example, a pressure differential may be generated between the first and second ends of the channel. A positive pressure may be provided at the first ends 823a, 823b of the channels and/or a negative pressure may be provided at the second ends of the channels. The positive pressure may be positive relative to the pressure at the second end of the channel and/or the ambient air. The negative pressure may be negative with respect to the pressure at the first end of the channel and/or the ambient air. In one example, vessels 846a and 846b may each have a vacuum therein. When the second end of the channel penetrates the vessel, the negative pressure within the vessel may draw the sample into the vessel. In alternative embodiments, the sample may be driven into the vessel by capillary force, gravity, or any other motive force. Alternatively, there may be a single or multiple combinations of forces to fill the vessel with fluid.

In some cases, different types of motive forces may be used to draw sample into the channel and from the channel into the vessel. For example, capillary forces may draw a sample into the channel, while pressure differentials may drive the sample from the channel into the vessel. Any combination of motive forces may be used to draw sample into the channels and into the vessels.

After the sample has been introduced into the channel, some time may elapse for the sample to travel along the length of the channel. A user may introduce a sample into the sample collection apparatus and may wait for the sample to travel along the length of the channel. One or more optical indicators may be provided along the length of the channel that may indicate whether the sample has reached the end of the channel. In other embodiments, the user may wait a predetermined amount of time before pushing in the body. The body may be pushed in after the user has determined that the sample has traveled a sufficient length of the channel and/or that a sufficient amount of time has elapsed since the sample was introduced. The body may have a flat surface that may be easily pushed by a user. In some cases, the planar surface may have a cross-sectional area that may be sufficient for a user's finger to press down on the body. After pushing the body, the channel may be brought into fluid communication with the vessel, and the sample may flow from the channel into the vessel. An optical indicator may be provided so that the user can know when the vessel is filled.

Once the vessel has been filled, it may be transferred to a desired location using the systems and methods described elsewhere herein. As previously described, the entire sample collection device may be transferred. In other embodiments, the base portion may be removable from the remainder of the device. In one example, the base may be removed from the sample collection device and the vessel may be transferred along with the base. Alternatively, the base may be removed from the sample collection device to provide access to the vessel, and the vessel may be removed from the device and transported.

With reference to fig. 9A-9B, an example of a sample collection device 900 and method of use will now be described. In one non-limiting example, the device can have a body 920, a stand 930, and a base 940. The main body 920, the stand 930, and the base 940 may be movable with respect to each other. In some cases, various components of the device may be movable during different stages of use. Examples of phases of use may include when the device is in an extended state, a compressed state, and a detached state.

Fig. 9A shows an example of device 900 in an extended state. The main body 920 may be extendable relative to the stand. Channels 922a, 922b configured to carry samples may be secured to the body. The first end of the channel may extend out from the body and/or the remainder of the sample collection device. The second end of the channel may be located within or contained by a portion of the sample collection device. The channels may be fluidly isolated from a corresponding vessel housed by the base 940. The stand 930 may be positioned between the body and the base. The stent may at least partially comprise a portion of the channel. In some cases, the stent may comprise a second end of the channel.

When in the extended state, the device may have an extended length. The length of the device may be from the bottom of the base to the first end of the channel. Alternatively, the length of the device may 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 extended state when a sample is introduced to the device. For example, the sample may be contacted by at least a first end of the channel. The sample may be drawn into the channel via capillary action or any other technique or motive force described herein. The forces may act alone or in combination to draw the sample into the device. The device 900 may remain in an extended state while the sample is traversing the channel. The sample may fill the entire length of the channel, a portion of the channel length, or at least a minimal portion to meet the desired sample collection volume.

Fig. 9B shows an example of the apparatus 900 in a compressed state. The main body 920 may be compressed relative to the stent. The channels 922a, 922b may be fixed to the body. The channels may be in fluid communication with their respective vessels. When the device is brought to a compressed state, the first channel may be brought into fluid communication with the interior of the first vessel and the second channel may be brought into fluid communication with the interior of the second vessel.

By way of non-limiting example, a user may push the main body 920 toward the support 930 (or vice versa) to bring the device into a compressed state. Relative movement between the components may involve movement of the two parts. Alternatively, moving may involve moving only one of them. In this example, the main body 920 may be pushed all the way to the stand 930 so that no interior portion of the main body is exposed and/or the flange of the main body contacts the stand. Any stop mechanism that can be engaged when the device is fully compressed can be used. Alternatively, the body may be pushed only partially. For example, a portion of the interior portion of the body may be exposed. The bracket may be positioned between the body and the base. The stent may at least partially comprise a portion of the channel. In some cases, the second end of the channel may extend beyond the scaffold of the device.

When in the compressed state, it is understood that the device 900 may have a compressed length. The length of the device 900 may be from the bottom of the base to the first end of the channel. Alternatively, the length of the device may 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 can be at least about 0.1cm, 0.5cm, 1.0cm, 1.5cm, 2.0cm, 2.5cm, 3.0cm, 3.5cm, 4.0cm, or 5.0cm less than the extended length of the device. The compressed length of the device may be less than or equal to about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97%, or 99% of the extended length of the device.

One or more engagement assemblies may be provided with the device 900. The engagement assembly may include a channel retainer 950 and/or a force application component, such as a spring 952 or rubber band. Retainer 950 may hold adapter channel 954 fixed to the cradle. As will be described elsewhere herein, the adapter channel 954 may be integrally formed with the collection channel, or may be a separate element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 950 may prevent the adapter channel 954 from sliding relative to the cradle. The retainer 950 may optionally provide a cradle on which a force applying component, such as a spring, may reside. When the device is in a compressed state, a force applying component, such as a spring, may be in a compressed state. The spring may exert a force on the body of the device when the device is in a compressed state.

The device may be in a compressed state when the sample is transferred from the channel to the respective vessel. In some examples, the transfer may occur via a pressure differential between the channel and the vessel interior as they are brought into fluid communication. For example, the second end of the channel may be brought into fluid communication with the interior of the vessel. The vessel may have a vacuum and/or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample may be drawn into the vessel. The device may remain in a compressed state while the sample is being transferred to the vessel. The sample may fill the entire vessel or a portion of the vessel. All of the sample from the channel (and/or more than 90%, 95%, 97%, 98%, 99%, 99.5%, or 99.9% of the sample) can be transferred to the vessel. Alternatively, only a portion of the sample from the channel may be transferred to the vessel.

Referring to fig. 9C, an example of the apparatus 900 in the detached state will now be described. The base 940 may be detached from the rest of the device 900. The main body 920 may be extended or compressed with respect to the support 930. In one example, the extended state may be a natural state such that when the user no longer applies a force to the body, the body may extend back to the extended state. The channels 922a, 922b may be fixed to the body.

When the device 900 is in the detached state, the base 940 may be detached from the stand 930 of the device. The channels 922a, 922b may be removed from fluid communication with their respective vessels 946a, 946 b. When the device 900 is brought to the disengaged state, the first channel may be brought out of fluid communication with the interior of the first vessel and the second channel may be brought out of fluid communication with the interior of the second vessel. This may occur sequentially or simultaneously. When the channel is removed from the vessel, the vessel may assume a sealed state to prevent unwanted material from entering the vessel. In some embodiments, the vessel may be fluid-tight after removal of the channel. Optionally, the vessel may be gas-tight after removal of the channel.

The user may detach the base 940 from the stand 930 to bring the device to a detached state to remove the vessel therein. In some embodiments, the base may be detached from the support, or vice versa. Separating the base from the stand may expose the vessels 946a, 946b supported by the base. The vessel may be press fit or otherwise retained within the base. The vessels 946a, 946b may be removable from the base. By way of non-limiting example, removing the vessels 946a, 946b allows them to be placed in a climate controlled shipping container with other vessels for shipment to a receiving site, such as, but not limited to, an analysis site. Optionally, the vessels 946a, 946b may be removed to allow for pre-processing, such as, but not limited to, centrifugation, before being transferred for processing at a receiving site, such as, but not limited to, an analysis site. Alternatively, the vessels 946a, 946b can remain with the base.

Fig. 10A-10B provide additional views of the sample collection device 1000 in a detached state. When in the detached state, the base 1040 can be detached (partially or completely detached) from the bracket 1030 and/or the body 1020 of the device. This allows removal of vessels 1046a and 1046b through the end of base 1040 that was not previously exposed when device 1000 was not in the detached state.

When the device is in the disengaged state, the one or more channels 1022a, 1022b can be fluidly isolated from the one or more vessels 1046a, 1046b housed by the base 1040. The vessels may be fluidly isolated from their environment. The vessels may contain therein a sample that has been transported through the collection channel, reaches a minimum fill level, and then is substantially completely deposited into the respective vessel. The base 1040 may include one or more optical indicators 1046a, 1046 b. The optical indicator may show a portion of the vessel therein so as not to move the device 1000 to the disengaged state until a minimum fill level has been reached in the vessel. By way of non-limiting example, the vessel may have a light transmissive material that allows a user to view the sample within the vessel from outside the base.

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

Collecting device with a plurality of collecting channels

With reference to fig. 11A-11F, further embodiments as described herein will now be described. This embodiment provides a bodily fluid sample collection device 1100 for collecting a fluid sample that may be pooled or otherwise formed on a surface, such as but not limited to the skin or other target area of a subject. Although the present embodiment shows a device body in which at least two collection channels of different volumes are defined, it should be understood that devices with a smaller or larger number of collection channels are not excluded. Embodiments using the same collection volume for one or more channels are not excluded. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Fig. 11A illustrates a perspective view of one embodiment of a bodily fluid sample collection device 1100 having a distal end 1102, the distal end 1102 being configured to engage a fluid sample on a surface. In this embodiment, the distal end 1102 may have a configuration designed to better engage a droplet or pool of bodily fluid or sample formed on the surface. In addition to the desired shape, some embodiments may also have a surface treatment at the distal end 1102, such as, but not limited to, a chemical treatment, texture, surface feature, or coating to promote fluid flow toward one or more openings 1104 and 1106 on the distal end 1102 leading to channels in the device 1100.

As seen in fig. 11A, the present embodiment of the sample collection device 1100 may have two openings 1104 and 1106 for receiving 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 a side or other surface leading away 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 may have a circular, elliptical, triangular, quadrilateral (e.g., square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may remain the same or may vary along the length of the collection device body. In some cases, the opening can have a width of less than or equal to about 2mm²、1.5mm²、1mm²、0.8mm²、0.5mm²、0.3mm²Or 0.1mm²Cross-sectional area of (a). Some embodiments may have openings of the same shape. Other embodiments may use different shapes for one or more openings.

The sample filling portion 1120 may be the body of the sample collection device 1100, which may be formed of a transparent and/or translucent material that may enable a user to see if a sample has entered one or more sample collection channels in the sample filling portion 1120 (see fig. 11B). In some embodiments, the entire sample fill portion 1120 is transparent or translucent. Alternatively, some embodiments may only have all areas on the channel or only selected portions of the channel or sample filling portion 1120 be transparent or translucent to allow a user to visualize the filling of the sample into the sample collection device 1100. Optionally, the sample filling section is made of an opaque material, but has an opening or window to allow visualization of the filling level therein. The apparatus 1100 may further include one or more visualization windows 1112 and 1114 to allow a user to see when a desired fill level has been reached. The visualization window may be formed of a transparent and/or translucent material. Alternatively, the visualization window may be an opening without any material therein. Additional visualization windows may also be used to determine that all of the fluid in the collection channels has been emptied into the vessels 1146a and 1146B (see fig. 11B).

Fig. 11A also shows that some embodiments of the stand 1130 may have optical windows 1132 and 1134 positioned to show the fill levels in the vessels 1146a and 1146b, showing whether the vessels in the base 1140 have been moved into position to receive the sample fluid. Alternatively, windows 1132 and 1134 may be cutouts that act as rails for snap features of the base to define the starting and ending positions during activation. It should be understood that the base may be configured to hold one or more sample vessels. By way of example and not limitation, the entire base 1140 may be removed from the sample collection device before or after sample filling. The base 1140 may serve as a holder to retain sample vessels therein during transport, and in such embodiments, the base 1140 will be loaded into a shipping tray or other holder for transport along with the sample vessels. Alternatively, some embodiments may remove the sample vessels from the base 1140 and then transport the vessels without holding them with the base 1140.

FIG. 11B shows a cross-sectional view along section line B-B of the embodiment shown in FIG. 11C. FIG. 11B shows channels 1126 and 1128 in portion 1120. The sample filling portion 1120 may be formed of two or more pieces joined together to define the portion 1120. Some embodiments may define the channel in one piece and then have another piece that cooperates with the first piece to define the opposing wall or top wall surface of the channel. This allows one part to have a channel molded or otherwise formed in the body in terms of manufacturing, and the opposing part will cooperate to act as a cover for the channel or may also include portions of the channel. The channels 1126 and 1128 may be formed only in the portion 1120, or may also extend into a stand 1130, the stand 1130 having features to connect with a vessel held in the base or carrier 1140. Some embodiments may have portion 1120 and portion 1130 integrally formed together. The stand 1130 may also be configured to hold an adapter channel 1150, which adapter channel 1150 will fluidly connect the channels 1126 and 1128 with their respective vessels 1146a and 1146 b.

Although the embodiments herein are described as using two channels and two vessels, it should be understood that other numbers of channels and vessels are not excluded. Some embodiments may have more channels than vessels, where some channels would be coupled to the same vessel. Some embodiments may have more vessels than channels, in which case multiple vessels may be operably coupled to the same channel.

As seen in fig. 11B, the channels 1126 and 1128 may be of different sizes. This allows different fluid volumes to be collected in each channel before they are transferred simultaneously into the vessels 1146a and 1146 b. Optionally, some embodiments may have channels 1126 and 1128 sized to contain the same volume of fluid. In some embodiments, the fluid passageways of the channels 1126 and 1128 are shaped and/or angled such that the openings near the distal end 1102 are closer to each other than the proximal end, which may be further spaced apart to align them for entry into the vessels 1146a and 1146 b. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire 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. The needles each have a channel to allow fluid to pass therethrough from the collection channels 1126 and 1128 to the tip of the needle. As seen in fig. 11B, vessels 1146a and 1146B in base 1140 can slide relative to stand 1130, as indicated by arrow 1156. Relative movement between support 1130 and base 1140 can reduce gap 1154. Narrowing the gap 1154 brings the adapter channel 1150 into the cap 1148a of the vessel 1146a until there is fluid communication between the interior of the vessel 1146a and the collection channel 1126. At this point, the motive force in form will in turn move the fluid in the channel 1126 into the vessel 1146 a.

By way of example and not limitation, any combination of motive forces may be used to draw a sample into a vessel. Some embodiments may use a pulling force from the vacuum in vessel 1146a to draw the sample into the vessel. Some embodiments may use a thrust from an external pressure to move the fluid into the vessel. Some embodiments may use both forces simultaneously. Some embodiments may rely on capillary and/or gravitational forces. In some embodiments, the one or more motive forces for aspirating the sample into the channel are different from the one or more motive forces for aspirating the sample into the vessel. In some alternative embodiments, the one or more powers may be the same for each stage. In some embodiments, the one or more motive forces are applied sequentially or for a defined period of time. By way of non-limiting example, one or more motive forces to draw sample into the vessel are not applied until at least one channel has reached a minimum fill level. Optionally, the one or more motive forces to draw the sample into the vessel are not applied until at least two channels have each reached a minimum fill level for that channel. Optionally, one or more motive forces to draw sample into the vessel are not applied until all channels have each reached a minimum fill level for that channel. In some embodiments, one or more power is applied simultaneously. These enumerated features may be applicable to any of the embodiments herein.

Referring now to FIG. 11E, an enlarged cross-sectional view of the device 1100 is shown. This embodiment shows that stand 1130 has a flange portion 1136, which flange portion 1136 is sized to extend a sufficient amount over adapter channels 1150 and 1152 to prevent a user from inserting a finger into gap 1154 and piercing a finger on one of the needles.

Further, as shown in fig. 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 a different material into the sample. By way of non-limiting example, if the sample is whole blood, one channel may introduce heparin into the blood while the other channel introduces ethylenediaminetetraacetic acid (EDTA). These anticoagulants not only prevent premature blockage of the channels during filling, but also introduce anticoagulant into the whole blood in preparation for transport in vessels 1146a and 1146 b. Optionally, one or more of the channels may be plasma coated in addition to or instead of anticoagulant. The plasma coating may reduce the flow resistance of the bodily fluid sample in the channel. Such coatings may be applied in a pattern such as, but not limited to, a stripe, a ring, or other pattern along with any other coating or coatings to be used in the channel.

Optionally, there is a sufficient amount of anticoagulant in the respective channels such that after only a single pass of the fluid through the channels, the sample fluid will contain a desired level of anticoagulant in the sample fluid. In conventional blood vials, the blood sample does not contain anticoagulant until it enters the vial, and once in the vial, the technician typically repeatedly tilts, shakes, and/or agitates the vial to enable mixing of the anticoagulant in the vial. In this embodiment, the sample fluid will contain anticoagulant prior to entering the sample vessel, and it will do so without having 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 54uL, coated with 200mg/mL EDTA; the channel of heparin has a volume of about 22uL, coated with 250 units/mL heparin. In another embodiment, the EDTA channel has a volume of 70uL, coated with 300mg/mL EDTA; the channel of heparin has a volume of about 30uL and is coated with 250 units/mL heparin. By way of non-limiting example, channels having a volume of from 50uL to 70uL may be coated with EDTA, which ranges from about 200mg/mL to 300mg/mL of EDTA. Alternatively, channels with volumes from 70uL to 100uL may be coated with EDTA, ranging from about 300mg/mL to 450mg/mL of EDTA. Alternatively, channels with volumes from 20uL to 30uL may be coated with heparin, ranging from 250 units/mL heparin. For example, the material may be a solution that is coated on the target surface for less than 1 hour and then dried overnight. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

With reference to fig. 11G, a further embodiment will now be described. The embodiment of fig. 11G shows that at the distal end 1202 of the sample collection device 1200, the sample collection device 1200 merges two or more channels into a single channel, rather than having one opening 1204 for each channel. The embodiment of fig. 11G shows that there is a common channel portion before the common channel is split into a plurality of separate channels. As will be described below in fig. 11I, optionally, there may be a backflow preventer, such as, but not limited to, a vent hole positioned along a separate channel, to reduce the likelihood of sample being aspirated from one channel to another during filling and/or withdrawal of sample from the channel into one or more vessels.

As seen in fig. 11H, the use of such a common flow path may create a reduced number of openings on the exterior of the sample collection device 1200, which may be aligned with the openings 1204 to engage the bodily fluid sample. It may also increase the capillary force used to draw the bodily fluid sample into the sample collection device 1200 by having more capillaries pulling on the same channel that the bodily fluid sample enters the collection device.

Referring to FIG. 11I, a cross-sectional view of selected components of the sample collection device will now be described. Fig. 11I shows that the sample collection device may have two channels 1182 and 1184 with a common portion 1186 leading to an inlet opening on the device. In some embodiments, the common portion 1186 is a continuation of one of the channels 1182 or 1184 in terms of size, shape, and/or orientation. Optionally, the common portion 1186 is not the same size, shape, and/or orientation as any of the channels 1182, 1184, or any other channel that may be in fluid communication with the common portion 1186. Fig. 11I shows that in one non-limiting example, a spoiler may be present at the interface 1188 between the channels 1182 and 1184. The interface 1188 may be configured to ensure flow into both channels so that they will both reach full fill. In one embodiment, the interface 1188 has a larger dimension than the channel 1182 leading away from the interface 1188. Although other dimensions are not excluded, the larger size of the interface 1188 may ensure that sufficient flow will enter the passageway 1182, the passageway 1182 having a smaller diameter and reduced volume relative to the passageway 1184 in this embodiment. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Fig. 11I also shows that vent holes 1190 and 1192 may be present, which may be used to prevent cross flow between channels, particularly when the sample is being transferred into the sample vessel. In one embodiment, the vent holes 1190 and 1192 are open at all times. In another embodiment, the vent holes 1190 and 1192 may be open only at selected times, such as, but not limited to, after the channels 1182 and 1184 are filled or substantially filled. Some embodiments may use a dissolvable material to plug the vent holes 1190 and 1192 until they come into contact with the sample fluid. Optionally, some embodiments may cover one or more of the discharge holes 1190 and 1192 with a slidable cover so that they are only open at times selected by the user. In one embodiment, the cover is joined to the sample vessel such that movement to move into the sample vessel in fluid communication with the channels will also open the one or more vent holes 1190 and 1192 to reduce the risk of cross flow between the channels. Optionally, other anti-cross-flow mechanisms, such as, but not limited to, valves, gates, or plugs may also be used to prevent fluid transfer between channels 1190 and 1192.

Fig. 11I also shows that there may be a leak prevention device 1194 positioned over the adapters 1150 and 1152. In this embodiment, the leak prevention devices 1194 are frits that are slidably movable from a first position in which they prevent the sample from leaking out of the adapters 1150 and 1152 to a second position in which they allow the adapters to deliver fluid into the sample vessels. In one non-limiting example, the leak prevention device 1194 will slide as it is engaged by the sample vessel or housing that houses the sample vessel. Movement of the sample vessel or housing in this non-limiting example shows that movement of these elements will also result in movement of the leak prevention device 1194.

Referring to fig. 11J, yet another embodiment of a sample collection device 1160 will now be described. This embodiment of the sample collection device 1160 shows that the device 1160 has a sample entry location 1204, the sample entry location 1204 leading to a plurality of channels 1162 and 1164 in the device 1160. Although fig. 11J illustrates that the channels 1162 and 1164 may have different shapes and/or sizes, some embodiments may be configured to have the same volume and/or shape. It should also be understood that the sample entry location 1204 may be on a surface of the device 1160 or, alternatively, it may be a portion of a tip, nozzle, shaft end, or other protrusion extending from the body of the device 1160. The protrusion may be in the same plane as and aligned parallel to the body of the device, or alternatively it may be angled such that the axis of the protrusion intersects the plane of the device 1160.

Fig. 11J further illustrates that for some embodiments, sample flow features 1166 and 1168 may be present to draw in or otherwise preferentially direct the sample in a desired direction. In some embodiments, features 1166 and 1168 are rails that operate to reduce channel dimensions (such as, but not limited to, width or height) in at least one axis and thereby increase capillary action through those reduced-dimension regions. In one non-limiting example, these flow features 1166 and 1168 can assist fluid flow through the channel region near the anti-cross flow features 1170 as the sample enters the channel. In one embodiment, the flow features 1166 and 1168 are sized to preferentially improve flow in the inward direction when flow is drawn primarily by capillary action. In one case, the outward flow is not based on capillary forces, but rather on vacuum pull forces (such as pull forces from adjacent channels), and the flow features 1166 and 1168 of this embodiment are not configured to provide assistance in those vacuum, non-capillary flow conditions. Thus, some, but not all, embodiments of the flow features 1166 and 1168 are configured to assist in at least one type of flow condition, but not some other flow condition or conditions. Alternatively, some embodiments may use other techniques (such as, but not limited to, shaping features, one or more hydrophobic materials, one or more hydrophilic materials, or other techniques) alone or in combination with the guide rails to push/pull the sample in the desired direction.

Fig. 11J also shows that in one or more embodiments herein, there is an angled sidewall feature 1167 that conically or otherwise narrows the cross-sectional area of the channel in a manner that funnels the sample to minimize the amount of sample that can remain in the channel without being collected. Fig. 11J also illustrates that one or more locating features 1169 can be present to help couple the components together in a defined position and orientation during manufacturing.

Fig. 11K shows a side view of this embodiment of a sample collection device 1160. The side view of the device 1160 shows that there is an embodiment: wherein one or more cross-flow prevention features 1170 (such as, but not limited to, vent holes) are present to minimize undesired cross-flow of sample between the channels 1162 and 1164, particularly when a desired fill level has been reached in the respective channels. The cross-flow prevention features 1170 and 1172 prevent cross-flow due to the vent holes creating a break in the fluid pathway. The cross-flow problem itself most often occurs when the vessels in the holder 1140 are engaged and provide additional motive force to pull the sample from the channels into the vessels. Such a "pulling" effect may inadvertently draw 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 will pull from the vent hole rather than the fluid in the adjacent channel, minimizing undesired mixing of the sample.

Fig. 11K also shows that in some embodiments herein, there are common portions 1130 and 1140 that may be adapted for use with different sample fill portions 1120. Some embodiments may use different capillary fill sections 1120. Some embodiments may use such a filling part: the filling portion uses different types of capture techniques, such as, but not limited to, samples collected from venous blood draws, arterial blood draws, or other samples drawn from an internal location or target site of the subject.

Referring now to fig. 11L, one embodiment of sample flow features 1166 and 1168 is shown. This cross-sectional view of the sample collection portion with channels 1162 and 1164 and sample flow features 1166 and 1168 near common inlet passage 1165 shows that in one embodiment, the features are desirable near where the sample enters the channels. Fig. 11L also shows that for channels of different volumes, it may be desirable to position the inlet 1165 closer to the channel 1164 having a larger volume, as seen by the asymmetric location of the inlet 1165. It can also be seen that in some embodiments, one or more positions of the sample flow features 1166 and 1168 can also be selected to control the fill rate, fill volume, etc. in the sample collection device 1160. It should be understood that one or more of the described features may be adapted for use with other embodiments herein.

Referring now to FIG. 11M, there is shown channels 1162 and 1164 having sample anti-cross-flow features. In one embodiment, the sample anti-cross flow feature is vent holes 1170 and 1172 located on at least one surface of channels 1162 and 1164. In one non-limiting example, these sample anti-cross flow features are located near any of the sample flow features 1166 and 1168 in the device. In one embodiment, these anti-cross flow features are configured to prevent flow between channels. These anti-cross flow features may be located near the maximum fill position of each channel so that when the channel is at or near its maximum sample capacity, the anti-cross flow features 1170 and 1172 are positioned to prevent overfilled sample from causing sample that has been processed in one channel to enter the other channel and undesirably mix samples from both channels together.

Fig. 11N shows a perspective view of a sample collection device 1160 with sample fill indicators 1112 and 1114. In one embodiment, these indicators 1112 and 1114 are openings or transparent portions of the device 1160 that allow viewing of at least a portion of one or more of the channels 1162 or 1164. When the sample is visible in at least one of the indicators 1112 and 1114, it provides a prompt to the user to then take another action, such as, but not limited to, engaging a sample vessel in the holder 1140. In some embodiments, there is only one sample fill indicator that is a surrogate for adequate filling of samples in two or more channels. In some embodiments, action is taken to engage the sample vessel only when indicated by indicators 1112 and 1114. In some embodiments, action is taken to engage the sample vessel only when indicated by only one of the indicators.

Referring now to FIGS. 11O, 11P, and 11Q, cross-sections at various locations along one embodiment of the device 1160 in FIG. 11J are shown. Fig. 11O shows a cross section showing sample flow features 1166 and 1168. Anti-cross flow features 1170 and 1172 are also shown. Engagement features 1174 may also be provided to enable the parts to fit together to form the device 160.

Fig. 11P illustrates positioning of adapter channels 1150 and 1152 to extend into or at least be in fluid communication with sample channels 1162 and 1164. Optionally, some embodiments may have a multi-lumen adapter channel 1150 or 1152. Alternatively, some embodiments may have multiple adapter channels per sample channel, where such additional channels may be parallel to each other, angled to each other, wrapped around each other, or otherwise oriented relative to each other.

Fig. 11Q illustrates that in some embodiments, the vessel retainer 1140 may be asymmetrically shaped (in cross-section) or otherwise shaped such that the retainer 1140 can only be received in one orientation in the device 1160. This may be particularly desirable when it is desired to direct a sample from a certain channel into a selected channel. If the holder 1140 can be inserted in various orientations, the sample from one channel may end up in the wrong vessel. Optionally, other features, such as alignment features, grooves, visual cues, texture cues, etc., may be used to facilitate preferred orientation of the sample vessel in the device.

Integrated tissue penetrating member

Referring to fig. 11R, yet another embodiment of a sample collection device will now be described. The sample collection device 1210 includes features similar to those shown in fig. 11G, except that it further includes a tissue penetrating member 1212 mounted to the sample collection device 1210. An actuation mechanism 1214, such as, but not limited to, a spring actuator, may be used to launch the tissue penetrating member. Fig. 11R illustrates the actuation mechanism 1214 in a ready-to-use state, and illustrates that it can be a spring that can be compressed to launch the tissue penetrating member 1212 toward the target tissue. The tissue penetrating member 1212 may be housed within a housing 1216 (shown in phantom). In one embodiment, the housing 1216 includes a portion that can be peeled, pierced, released, or otherwise opened to allow the tissue penetrating member 1212 to exit the housing but also maintain its sterility prior to use of the tissue penetrating member 1212. In some embodiments, the portion may be a foil, cap, polymer layer, or the like. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the tissue penetrating member 1212 path may be controlled to simultaneously follow both the "normal" (i.e., forward direction of the tissue penetrating member) and "orthogonal" (i.e., perpendicular to the primary motion vector) trajectory. Some embodiments may not have a hard stop or a hard stop at the deepest point of penetration (i.e., the return point), which is the primary cause of spontaneous pain. Some embodiments may use a pad, cam path, or other non-hard stop mechanism to prevent pain associated with a shock wave that suddenly stops. Such a shock wave is detrimental even if the tissue penetrating member successfully avoids impacting nerves near the wound site, because the shock wave can activate such nerves even if direct contact is avoided. Optionally, some embodiments may have a tissue penetrating member that follows a non-jittery path to prevent rough wound channels (residual pain). This may be accomplished in some embodiments by tighter tolerances in any guide pathway used with the tissue penetrating member or a pin associated with the tissue penetrating member. This may be a non-jittered path when penetrating tissue. Alternatively, this may be a non-jittered path of the tissue penetrating member outside of the tissue and when it is inside of the tissue. This may reduce the overall motion "wobble" of the tissue penetrating member that may lead to residual pain, permanent trauma, and scarring.

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

Some embodiments may also include a ballistic prevention mechanism to prevent accidental re-lancing that may be associated with an uncontrolled tissue penetrating member that rebounds into tissue after an initial wound is created. Some embodiments herein may have a "docking" or locking mechanism that will engage the tissue penetrating member or its attachment to prevent re-entry of the tissue penetrating member once it is retracted or retracted any other desired distance from the tissue.

The jerk at which the lancet stops at the maximum depth in the skin before it begins its outward movement and returns to its starting position is an inherent problem in this design. The greatest amount of force is applied to the skin when the lancet is at the deepest point of its penetration. The drive mechanism simply bounces off the end of the device as if the ball bounced off the floor. A lancet that comes to a sudden stop at the end of its inward movement transmits a shock wave into the skin, causing many pain receptors in the vicinity of the lancet to fire even though they are not directly struck. This greatly amplifies spontaneous pain.

As previously described, some embodiments may use mechanical cam actuation instead of a simple spring-actuated tissue penetrating member. Devices having a cam-actuated design may minimize "hard stops" of the tissue penetrating member. The cam mechanism is typically spring driven and generally provides better guided actuation. The trajectory of the tissue penetrating member is tightly controlled via a pin riding in a cam to pass through the guide path of the tissue penetrating member holder. The cam mechanism allows for a predetermined speed profile with a softer return and a well-defined speed control of the tissue penetrating member outward trajectory. The mechanism also effectively avoids the rebound of the lancet into the skin when the mechanism reaches the end of its movement. Furthermore, when launched in air, the mechanical oscillation (or wobble) of the lancet path in both directions is reduced. Some embodiments herein may also minimize any mechanical oscillation of the drive mechanism (e.g., due to uneven or rough cam grooves) to prevent such drive mechanism oscillation from being directly transferred into tissue due to its "forced motion profile".

Alternatively, some embodiments may use electronic actuation through an electronically controlled drive mechanism. This technique uses a miniaturized electronic motor (e.g., voice coil, solenoid) coupled to a very accurate position sensor to move the tissue penetrating member into and out of the skin with precisely controlled motion and speed. After rapid entry, the device decelerates the tissue penetrating member to an accurate, preset depth for smooth, jitter-free, and relatively slow return. This allows for rapid wound closure and avoids long term trauma. With this device, the force required to penetrate the lancet into the skin is controlled as the tissue penetrating member is advanced. The benefit of tight control of the tissue penetrating member actuation "profile" is reproducible painless blood sampling that yields an adequate and consistent blood sample for testing.

With respect to puncture site creation for blood sample extraction, it may be desirable to select a suitable puncture site on a finger (ring finger or middle finger) on the patient's non-dominant hand. The puncture site may be located on the side of the finger tip. In one non-limiting example, it may be desirable to hold the warm hand strap against the selected finger of the patient for 15 seconds. Optionally, some embodiments may warm one or more fingers of the patient for from 10 to 60 seconds. Other embodiments may warm the fingers for longer periods of time. Such warmth will increase blood flow to the target site. To prepare the target site, it may be desirable to wipe the side tip of the selected finger or the surface of the subject with an alcohol wipe or similar cleansing agent to ensure that the selected puncture site is wiped. In some embodiments, it is desirable to wait until the skin is completely dry. Typically, no gauze or air blows on the fingertips are used to accelerate drying.

After the puncture has been made, the finger is held down, below the patient's waist, to allow blood flow. Gently massage the finger from the base to the tip until a drop of blood is formed. The blood collection device is carefully filled by touching the tip of the device to the bead of blood on the finger. Ensuring that the device is completely filled. Once the blood collection device was filled, the bleeding area of the finger was pressed onto a gauze pad on a table. The blood sample is transferred to a collection vessel. Place a bandage over the finger. The vessel with the sample is placed into a shipping box within a refrigerator. All supplies were discarded into biohazard sharps vessels. All supplies are for single use only.

If not enough blood is obtained from the first puncture, the blood collection device is carefully placed on a table surface, ensuring that the device remains level. A bandage is placed over the punctured finger. The appropriate puncture site is selected on a different finger on 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. The warm hand strap is held against the selected finger of the patient for 60 seconds. Optionally, some embodiments may warm one or more fingers of the patient for from 30 to 90 seconds. This will increase the blood flow to the finger. These techniques for blood collection using a sample collection device, such as any of the sample collection devices herein, can support adequate sample collection of capillary blood for laboratory testing under Clinical Laboratory Improvement Amendments (CLIA) -certified facilities and/or standards.

Referring to fig. 11S, yet another embodiment of a sample collection device 1220 will now be described. In this embodiment, the tissue penetrating member 1222 may be mounted at an angle relative to the sample collection device 1220. This angled configuration allows the tissue penetrating member to create a wound in a position aligned with one or more of the sample acquisition openings 1103 and 1105. While a standard spring-fired actuator is shown as the drive mechanism 1224 for the tissue penetrating member 1222, it should be understood that a cam and/or electric drive system may also be used in place of or in conjunction with the spring-fired actuator. When the drive mechanism 1224 is a spring, the spring can be compressed to move the tissue penetrating member 1222 to a firing position and released to penetrate the target tissue. Fig. 11S shows the tissue penetrating member 1222 in a ready position. Although the figures show a spring for the drive mechanism 1224, it should be understood that other drive mechanisms suitable for launching a tissue penetrating member to create a healable wound on a subject are not excluded. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

A housing 1226 may be formed around tissue penetrating member 1222 similar to that described for housing 1216. Although fig. 11S shows two tissue penetrating members 1222 mounted on the sample collection device, it should be understood that devices having more or fewer tissue penetrating members are not excluded. For example, some embodiments may have only one tissue penetrating member 1222 mounted to the sample collection device 1220. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Referring to fig. 11T, another embodiment of a sample collection device 1230 will now be described. This embodiment shows the tissue penetrating member 1232 contained within the sample collection device 1230 and, as seen in fig. 11T, is actually coaxially aligned with the central axis of the sample collection device. This positions the tissue penetrating member 1232 for extending outwardly from the sample collection device 1230 at a location proximate to where the openings 1103 and 1105 are positioned on the sample collection device 1230. Of course, devices having more or fewer openings are not excluded and the embodiment of fig. 11T is exemplary and non-limiting. Fig. 11T shows that in one embodiment of the sample collection device, the firing button 1234 can be mounted on the sample collection device 1230. Alternatively, some embodiments may have a shaped leading end 1236, the leading end 1236 functioning as an actuation button, wherein the tissue penetrating member will be actuated when tissue is pressed onto the leading end 1236 to a particular depth and/or a particular pressure.

Once fired, the tissue penetrating member 1232 is moved as indicated by arrow 1233. In some embodiments, the tissue penetrating member 1232 is completely contained within the sample collection device 1230 prior to actuation. Some embodiments may have visual indicators 1235 on the device 1230 to help guide the user as to where the tissue penetrating member 1232 will exit the device and where a wound will generally form.

In this non-limiting example, the entire device 1230 may be in a sterile pouch or package that is opened only prior to use of the device 1230. In this manner, sterile conditions may be maintained for the tissue penetrating member and collection device prior to use. Such an external sterile bag or package may also be suitable for use with any of the other embodiments herein. Fig. 11L also shows a shaped front end 1236 (shown in phantom) that may be integrally formed or may be separately attached to the sample collection device 1230. Such a shaped front end 1236 can provide suction to draw sample fluid into the sample collection device 1230. Optionally, the shaped front end 1236 can be used to stretch and/or force target tissue into the shaped front end to apply pressure to increase the amount of sample fluid from the wound formed by the sample penetrating member 1232. It should be understood that any of the embodiments herein may be adapted to have a shaped front end 1236. Optionally, the shaped front end may have one or more selected hydrophobic regions to direct sample fluid toward one or more collection regions on the front end. Optionally, the shaped front end may have one or more selected hydrophilic regions to direct sample fluid towards one or more collection regions on the front end.

With reference to fig. 11U, yet another embodiment of a sample collection device will now be described. This embodiment is similar to the embodiment of fig. 11T, except that the embodiment of fig. 11T uses multiple tissue penetrating members 1242 instead of a single tissue penetrating member such as a lancet. In one embodiment, these tissue penetrating members are microneedles 1242 having a reduced diameter compared to conventional lancets. Multiple microneedles 1242 can be actuated simultaneously for device 1240 and create multiple wound sites on the tissue. The spacing of the microneedles 1242 may result in more capillary loops being pierced and more channels available for blood to reach the tissue surface. This also allows for a more "square" penetration profile than a lancet with a sharp tip and a tapered profile. This may enable the microneedles 1242 to engage more capillary loops over a larger area without penetrating too deep into deeper tissue layers that are more densely populated with nerve endings.

With reference to fig. 11V and 11W, a further embodiment of a sample collection device will now be described. In the embodiment shown in these figures, the sample collection device 1100 may be mounted at an angle to a dedicated wound creation device 1250, the dedicated wound creation device 1250 having a tissue penetrating member 1252 configured to extend outwardly from the device 1250. The sample collection device 1100 may optionally be configured with a shaped front end 1236 (with or without an opening to accommodate the tissue penetrating member 1252) that may be removably mounted to the wound-creating device 1250. Alternatively, the sample collection device 1100 may be mounted flat to the device 1250. Optionally, there may be a shaped cut-out on the device 1250 for press-fitting to retain the sample collection device 1100. It should be understood that other techniques for removably mounting the sample collection device 1100 are not excluded. Such decoupling of the collection device from the wound creation device allows for the use of a more complex, possibly non-disposable, wound creation device 1250 that can create a more controlled, pain-reducing wound creation experience.

Fig. 11W illustrates that the sample collection device 1100 can be aligned substantially horizontally to remain neutral with respect to the effects of gravity on sample collection. Other mounting arrangements of the device 1100 to the wound creation apparatus 1250 are not excluded.

With reference to fig. 11X-11Z, further embodiments of various sample collection devices will now be described. Fig. 11X illustrates a sample collection apparatus 1240 where a shaped front end 1236 can be used with the apparatus 1240. The shaped front end 1236 is similar to the shaped front ends described above. A vacuum source 1270 may be used to assist in drawing the bodily fluid sample into device 1240. The vacuum source 1270 may be coupled to the body of the apparatus 1240 and/or to the shaping front 1236. It should be understood that any of the embodiments described in this disclosure may be adapted for use with a sample collection aid, such as, but not limited to, a vacuum source 1270.

Fig. 11Y illustrates yet another embodiment of a sample collection device. This embodiment uses a pipette system having a tip 1280 for collecting sample fluid. The tip may include a coaxially mounted tissue penetrating member 1282. Optionally, a side-mounted or angled tissue penetrating member 1284 is shown to create a wound at the target site. A pipette system having a tip 1280 may apply a vacuum to pull sample fluid from a subject. Optionally, a shaped leading end 1236 may be used with the tip 1280 to assist with skin stretching or tissue remodeling at the target site.

Fig. 11Z illustrates that some embodiments can use the diaphragm 1291-coupled actuation mechanism to create a vacuum for aspirating a blood sample. Such coupling allows the septum to create a vacuum on the return stroke of the tissue penetrating member 1292 from the target site. In one embodiment, the tissue penetrating member 1292 is a microneedle. Actuation of the tissue penetrating member launches the tissue penetrating member 1292 as indicated by arrow 1294 and creates a vacuum on the return path due to movement of the septum coupled with movement of the tissue penetrating member 1292. One or more vessels 1296 can be coupled to contain fluid collected by the device 1290. Some embodiments may have only one vessel 1296. Some embodiments may have a set of vessels 1296. Some embodiments may have multiple sets of vessels 1296. Some embodiments may be mounted externally on the device 1290. Some embodiments may be internally mounted in the device 1290. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Vertical outflow limiter

Fig. 11E also more clearly shows that there is a sleeve 1156 around adapters 1150 and 1152. Although shown only in fig. 11A-11F, it should be understood that a sleeve with or without vent holes may be configured for use with any of the embodiments contemplated herein. As seen in the embodiment of fig. 11E, the channel may be defined by a needle. These sleeves 1156 prevent premature flow of the fluid sample from the adapter channels 1150 and 1152 before the vessels 1146a and 1146b engage the needles. Preventing premature flow reduces the amount of fluid loss associated with the transfer of fluid from the channel to the vessel due to the small volume of sample fluid collected. In one embodiment, sleeve 1156 may minimize fluid loss by providing a sleeve that is liquid-tight but not air-tight. If the sleeve is air impermeable it may prevent the capillary action of the channel from functioning properly. Optionally, some embodiments may locate the vent hole near the base of the needle, distal to the tip, so that the sleeve may contain the sample at a location distal to the vent hole.

Fig. 11F shows that in an exemplary embodiment, sleeve 1156 is configured to have an opening 1158 therethrough. This provides an improved embodiment over conventional sleeves which are typically loose fit over the needle. Due to the loose fit, in conventional sleeves, there is a sleeve space in the tip and in the sidewall space between the needle and the sleeve, within which the fluid sample may accumulate. While a sleeve of this design may help prevent a greater loss of fluid by limiting the loss to a defined amount compared to a needle without a sleeve that may continue to lose fluid, fluid that accumulates in the sleeve area along the tip and sidewall is still lost and not collected by the vessel 1146a or 1146 b. The sleeve 1156 may also include a narrowed region 1176 to facilitate engagement of the sleeve to a device providing fluid communication with the channels 1126 and 1128, such as, but not limited to, a needle, probe, tube, channel, or other adapter channel 1150.

In the embodiment of fig. 11F, opening 1158 is sized based on a calculation sufficient to withstand the fluid pressure associated with the flow from the capillary action of the channel in sample fill portion 1120. This force allows the opening 1158 to vent air from the channel where it is located and also prevents fluid from exiting the sleeve until the vessels 1146a and 1146b are pushed to engage the adapter channels 1150 and 1152. Due to the venting effect created by opening 1158, the sleeve sidewall and other areas can be made to engage the needle much more tightly than in conventional sleeves. This reduces the clearance space between the needle and the sleeve and therefore minimizes the amount of fluid that may be lost compared to a sleeve without a discharge hole that has a much larger clearance space due to the loose nature of the fit. In addition, opening 1158 may also be sized so that once fluid reaches the opening, the opening provides sufficient resistance so that outflow from the channel or needle is also stopped so that fluid loss in any gap between the sleeve and needle tip is minimized thereat.

The calculation for setting the opening size is shown in fig. 12. It is desirable to balance the forces so that there is sufficient leakage resistance associated with the hydrophobic material defining the vent hole to contain the outflow of sample fluid outside the cartridge. In fig. 12, the sidewall of the sleeve 1156 may be in direct contact with the needle, or in some embodiments, there may be a gap along the sidewall of the sleeve. In one embodiment, sleeve 1156 comprises a hydrophobic material, such as, but not limited to, a thermoplastic elastomer (TPE), butyl rubber, silicone, or other hydrophobic material. In one embodiment, the thickness of the sleeve will also determine the length of the side wall of the opening or vent 1158 in the sleeve 1156.

The openings 1158 may be located at one or more locations along the sleeve 1156. Some embodiments may have openings as shown in fig. 12. Alternatively, some embodiments may have openings 1158 located on the sidewall of the sleeve. Other locations are not excluded. Optionally, the sleeve 1156 may have a plurality of openings therethrough, but configured such that fluid does not exit the sleeve and resistance from the openings is sufficient to prevent additional outflow from the channel until the vessel 1146a or 1146b is engaged with and in fluid communication with the channel.

With respect to how the device 1100 is used to collect a sample, in one technique, the sample collection device 1100 is held in engagement with the target bodily fluid and held in place until a desired fill level is reached. During this time, the device 1100 may be held horizontally to minimize the gravitational force that would need to be overcome if the device 1100 were held more vertically. After the fill level is reached, the device 1100 may be disengaged from the target fluid and then the vessels 1146a and 1146b engaged to draw the collected fluid into the vessels. Alternatively, the device 1100 may be left in contact with the target fluid and the vessel engaged in fluid contact with the channel so that the fill will draw in fluid in the channel and possibly also any additional sample fluid remaining at the target site. This may ensure that sufficient bodily fluid is drawn into the vessel.

After the vessels 1146a and 1146b are filled, the containers may be prepared for shipment. Alternatively, they may be sent for pre-treatment prior to shipment. Some embodiments of vessels 1146a and 1146b include a material in the vessel of a density such that, after a pretreatment such as centrifugation, the material, due to its selected density, will separate a portion of the centrifuged sample from another portion of the centrifuged sample in the same vessel.

The container 1146a or 1146b may have a vacuum and/or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample may be drawn into the vessel. Alternatively, the vessel may take the form of a test tube-like device having the properties of those sold under the "Vacutainer" trademark by Becton-Dickinson Company of East Rutherford, N.J.. When the sample is being transferred into the vessel, the device may remain in a compressed state with the base 1140 closing the gap 1154. The sample may fill the entire vessel or a portion of the vessel. All of the sample from the channel (and/or more than 90%, 95%, 97%, 98%, 99%, 99.5%, or 99.9% of the sample) can be transferred to the vessel. Alternatively, only a portion of the sample from the channel may be transferred to the vessel.

In one embodiment as described herein, the two-stage filling of the sample fluid into the sample collection device 1100 allows for: i) metered collection of sample fluid to ensure that a sufficient amount is obtained in the collection channel treated to prevent premature coagulation, and then ii) an efficient way of transferring a high percentage of sample fluid into the vessel. Such low loss filling of the vessel from the pre-fill channel to meter a minimum amount of sample fluid into the vessel 1146 provides various advantages, particularly when dealing with collecting small volumes of sample fluid. Prefilling the channels to a desired level ensures that there is a sufficient volume in the vessel to perform the desired detection of the sample fluid.

As described herein, the entire device, including sample filling portion 1120, stand 1130, and base 1140, is completely transparent or translucent to allow visualization of the components therein. Optionally, only one of sample fill portion 1120, stand 1130, and base 1140 is completely transparent or translucent. Optionally, only selected portions of the sample filling portion 1120, the support 1130, or the base 1140 are transparent or translucent. The user may then more accurately determine when to perform various procedures based on the progress of the sample fluid filling and the engagement of the sample vessel to the channel in the sample filling portion 1120. Air bubbles in the collection channel may be visible during filling, and if they are seen, the user may adjust the position of the sample collection device 1100 to better engage the target sample fluid, thereby minimizing air draw into the channel. It will also allow the user to know when to disengage or disengage a feature such as the base or vessel holder 1140 when filling is complete.

It should be understood that other methods may be used to prevent sample flow out of the adapter channels 1150 and 1152 if the device is held at a non-horizontal angle (such as, but not limited to, vertically downward). In one embodiment, the frit 1194 may be used with a needle having a central bore that serves as the adapter channels 1150 and 1152. The frit may be located within the body of the sample collection device or on the collection container. In some embodiments, the frit comprises a material such as, but not limited to, PTFE. Alternatively, some embodiments may use tape/adhesive on the needles that function as adapter channels 1150 and 1152. In one embodiment, tape and/or adhesive may be used to cover the needle opening to prevent premature discharge of the sample. Optionally, some embodiments may have such adapter channels 1150 and 1152: it has a hydrophobic surface to prevent controlled outflow from the adapter channel opening to the sample vessel. In some embodiments, adapter channels 1150 and 1152 are needles having hydrophobic material only on the inner surface near the outlet. Optionally, the hydrophobic material is located only on the outer surface of the needle near the outlet. Optionally, the hydrophobic material is located on the inner and outer surfaces of the needle. Alternatively, another method of preventing downward flow is to increase the surface area of the capillary by changing the cross-section. By way of non-limiting example, some embodiments may incorporate teeth or fingers within the capillary in order to increase the surface area in the cross-section of the capillary. Optionally, some embodiments may include fins within the capillary tube towards and/or away from the fluid flow in order to increase the surface area in the cross-section of the capillary tube. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

One sample collector location leading to multiple channels

With reference to fig. 13A-13B, yet another embodiment as described herein will now be described. Fig. 13A shows a top view of sample fill portion 1320 with a single collection location 1322, such as, but not limited to, a collection well where two channels 1324 and 1326 meet to draw fluid away from the single sample collection location 1322. Alternatively, some embodiments may use a Y-shaped split channel configuration, where only a single channel leads away from collection location 1322 and then splits into channels 1324 and 1326 after having been a single common channel leading away from collection location 1322. A member providing fluid communication to channels 1324 and 1326, such as, but not limited to, a needle, probe, tube, channel, hollow elongated member, or other structure, may be coupled to one end of sample filling portion 1320.

Fig. 13B shows a side cross-sectional view in which collection location 1322 is shown and is in fluid communication with passage 1326, which in turn is in fluid communication with adaptor passage 1352, such as, but not limited to, a fluid communication member. In some embodiments, the fluid communication member may have sufficient rigidity and a sufficiently penetrating tip to pierce a septum, cap, or other structure of a vessel. Some embodiments may have a non-coring configuration of the adapter channels 1352, 1150, etc. so as to leave no holes in the septum, cap, or other structure of the vessel that would not seal.

As seen in fig. 13B, the sample fluid may be applied to or dripped into the collection location 1322, as indicated by droplet D. Alternatively, some embodiments may apply the sample fluid directly or in direct contact with the collection site 1322. Although embodiments herein are shown using only a single collection location 1322, it should be understood that other embodiments are also envisioned in which multiple channels are coupled to a common sample collection point. By way of non-limiting example, one embodiment of a collection device may have two collection locations 1322, each having its own set of passages leading away from its respective collection location. Some embodiments may combine the common collection point channel shown in fig. 13A-13B with a separate channel such as shown in fig. 11A-11F. Other combinations of common collection location structures with other structures having separate channels are not excluded.

Fig. 13B also illustrates that the present embodiments can include one or more tissue penetrating members 1327 configured to extend outwardly from collection location 1322. In one embodiment, this enables the user to place the target tissue simultaneously over the collection site 1322 and the wound creation site for fluid sample collection. Optionally, trigger 1323 may be positioned to fire the tissue penetrating member. Optionally, a trigger is built into the tissue interface of the device to support firing of the device when contacting the target tissue and/or when sufficient pressure or contact is in place. This overlap of the two positions allows a simplified protocol to be followed by the user for successful sample collection. The one or more tissue penetrating members 1327 may be actuated by one or more actuation techniques, such as, but not limited to, spring actuation, spring/cam actuation, electronic actuation, or a single or multiple combinations thereof. It should be understood that other ancillary methods such as, but not limited to, a vacuum source, a tissue tensioning device, a tissue engagement nozzle, and the like may also be used alone or in combination with any of the foregoing methods to improve sample collection.

With reference to fig. 13C, a further embodiment of a sample collection device will now be described. This embodiment shows a cartridge 1400 having a sample collection device 1402 integrated therein. There is a collection location 1322 and one or more sample openings 1325 and 1329, where sample collection may then be accessed at location 1322, such as but not limited to processing by a pipette tip (not shown). The sample from droplet D will travel along pathway 1326, as indicated by the arrows, towards openings 1325 and 1329, where any sample located in the openings and in pathways 1324 and/or 1326 leading to their respective openings 1325 and 1329 is drawn into pipette P. As indicated by the arrow near the pipette P, the pipette P is movable on at least one axis to support the transport of sample fluid to one or more desired locations. In this embodiment, the cartridge 1400 may have a plurality of containment vessels 1410 for reagents, wash fluids, mixing zones, incubation zones, and the like. Optionally, some embodiments of the cartridge 1400 may not include any containment vessels, or alternatively, only one or two types of containment vessels. Optionally, in some embodiments, the receiving vessel may be a pipette tip. Optionally, in some embodiments, the containment vessel is a pipette tip that: which is treated to include one or more reagents on the tip surface (typically, but not exclusively, the inner tip surface). Alternatively, some embodiments of cartridge 1400 may include only sample collection device 1402 and no tissue penetrating member, or vice versa.

Referring now to fig. 13D, a side cross-sectional view of the embodiment of fig. 13C is shown. Optionally, a sample penetrating member 1327 may be included for use in creating a wound for sample fluid to be collected at location 1322.

FIG. 14 shows that the sample filling portion 1320 can be coupled to the brackets 1330 and 1340 to form a sample collection device 1300. A visualization window 1312 may be present to see if the sample fluid has reached the desired fill level. A force applying component such as a spring 1356 or a rubber band may be included. The channel retainer may hold the channel fixed to the bracket. In one embodiment, the retainer may prevent the channel from sliding relative to the bracket. It may be coupled to the channel using press-fit, mechanical fastening, adhesive, or other attachment techniques. The retainer may optionally provide a cradle on which a force applying assembly, such as a spring, may reside.

In one example, the engagement assembly can include a spring 1356 that can exert a force such that the base 1340 is in an extended state when the spring is in its natural state. When the base is in its extended state, space may be provided between the vessels 1346a, 1346b and the engagement assembly. In some cases, the second end of the channel may or may not contact the cap of the vessel when the base 1340 is in its extended state. The second ends of the fluid communication members 1352 may be in a position where they are not in fluid communication with the interior of the vessel.

Bringing bracket 1330 and base 1340 together will bring channels 1324 and 1326 into fluid communication with vessels 1346a and 1346b when member 1352 penetrates the cap on the vessels, and thereby draw sample fluid into vessels 1346a and 1346 b.

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

As seen in fig. 15, in one embodiment as described herein, the two-stage filling of sample fluid into the sample collection device 1300 allows for: i) metered collection of sample fluid to ensure that a sufficient amount is obtained in the collection channel treated to prevent premature coagulation, and then ii) an efficient way of transferring a high percentage of sample fluid into the vessel. Such low-loss filling of the vessel from the pre-fill channel to meter a minimum amount of sample fluid into the vessel 1346 provides various advantages, particularly when dealing with collecting small volumes of sample fluid. Prefilling the channels to a desired level ensures that there is a sufficient volume in the vessel to perform the desired detection of the sample fluid.

With reference to fig. 16 and 17, a further embodiment will now be described. Fig. 16 shows a blood collection device 1300 having a secondary collection area 1324 around a collection location 1322. Secondary collection area 1324 may be used to direct any spilled, or misdirected fluid sample toward collection location 1322.

Fig. 17 further illustrates that vessels 1346a and 1346b can each have an identifier associated with vessels 1346a and 1346 b. FIG. 17 illustrates that in one non-limiting example, the identifiers 1600 and 1602 may be at least one of: a barcode (e.g., 1-D, 2-D, or 3-D), a Quick Response (QR) code, an image, a shape, a word, a number, an alphanumeric string, a color, or any combination thereof, or any type of visual identifier. Other embodiments may use markers that are not in the visible spectrum. Other embodiments may use RFID tags, RF tags, IR luminescent tags, or other markers that do not rely on identification by a signal transmitted through the visible spectrum.

The identifiers 1600 and 1602 may be used to identify a sample and/or a sample type in a sample collection apparatus. One or more identifiers may be present per vessel. Some embodiments may also use an identifier on the vessel holder. The identifier may identify the sample collection device, one or more individual vessels 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 vessel may be transported. In one example, the sample collection device, portions of the sample collection device, may be transported via a delivery service or any other service described elsewhere herein. The sample can be delivered to perform one or more assays on the sample.

The identity of the sample and/or the identity of the individual providing the sample may be tracked. Information associated with one or more individuals providing the sample (e.g., name, contact information, social security number, date of birth, insurance information, billing information, medical history) as well as other information of the sample provider may be included. In some cases, the type of sample (e.g., whole blood, plasma, urine, etc.) may be tracked. The type of reagent (e.g., anticoagulant, marker, etc.) that the sample will encounter can also be tracked. Additional information about the sample collection may be considered, such as the date and/or time of collection, the environment in which the sample was collected, the type of test to be performed on the sample, insurance information, medical record information, or any other type of information.

The identifier may assist in tracking such information. The identifier may be associated with such information. Such information may be stored external to the sample collection device, internal to the sample collection device, or any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, a computer, a database, or any other device with memory. In some cases, the information may be stored on a cloud computing infrastructure. One or more resources storing information may be distributed across the cloud. In some cases, a point-to-point infrastructure may be provided. The information may be stored in the identifier itself, or may be associated elsewhere with the identifier, or any combination thereof.

The identifier may provide a unique identification or may provide a high likelihood of providing a unique identification. In some cases, the identifier may have a visual component. The identifier may be optically detectable. In some cases, the identifier may be identifiable using visible light. In some examples, the identifier may be a barcode (e.g., 1-D, 2-D, or 3-D), a Quick Response (QR) code, an image, a shape, a word, a number, an alphanumeric string, a color, or any combination thereof, or any type of visual identifier.

In other embodiments, the identifier may be optically detectable via any other kind of radiation. For example, the identifier may be detectable via infrared, ultraviolet, or any other type of wavelength of the electromagnetic spectrum. The marker may utilize luminescence, such as fluorescence, chemiluminescence, bioluminescence or any other type of light emission. In some cases, the identifier may be a radio transmitter and/or receiver. The identifier may be a Radio Frequency Identification (RFID) tag. The identifier may be any type of wireless transmitter and/or receiver. The identifier may transmit one or more electrical signals. In some cases, a GPS or other location-related signal may be used with the identifier.

The identifier may comprise an audio component or an acoustic component. The identifier may emit a sound that may be recognizable to uniquely identify the identified component.

The identifier may be detectable via an optical detection means. For example, a barcode scanner may be capable of reading the identifier. In another example, a camera (e.g., a camera for still images or video images) or other image capture device may be capable of capturing an image of the identifier and analyzing the image to determine the identifier.

Fig. 16 and 17 illustrate examples of identifiers provided for use with a sample collection device 1300 according to embodiments described herein. In one example, the sample collection apparatus can include a base 1340 that can support and/or contain one or more vessels 1346a, 1346 b. The sample may be provided to a sample collection device. The sample may be provided to the sample collection device via inlet 1322. The sample may travel to one or more vessels 1346a, 1346b within the device.

One or more identifiers 1600, 1602 may be provided on the sample collection device. In some embodiments, the identifier can be positioned on the base 1340 of the sample collection device. The identifier may be positioned on a bottom surface of the base, a side surface of the base, or any other portion of the base. In one example, the base may have a flat bottom surface. The marker may be located on a flat bottom surface of the base. One or more recesses may be provided in the base. A marker may be located within the recess. The recess may be located on a bottom surface or a side surface of the base. In some embodiments, the base may include one or more protrusions. A marker may be located on the projection. In some cases, an identifier may be provided on an outer surface of the base. The identifier may alternatively be positioned on an inner surface of the base. The identifier may be detected from outside the sample collection device.

In some embodiments, the identifier may be provided on the vessels 1346a, 1346 b. The identifier may be located on an outer surface of the vessel or on an inner surface of the vessel. The identifier may be detectable from outside the vessel. In some embodiments, an identifier may be provided on the bottom surface of the vessel.

In one example, the base may include a light transmissive portion. The light transmitting portion may be located on the bottom of the base or on a side of the base. For example, a transparent or translucent window may be provided. In another example, the light transmissive portion may be a hole without a window. The light transmitting portion may allow portions within the base to be visible. The identifier may be provided on the outer surface of the base on the light transmissive portion, on the inner surface of the base but visible through the light transmissive portion, or on the outer or inner surface of the vessel but visible through the light transmissive portion. In some cases, the marker may be provided on an inner surface of the vessel, but the vessel may be light transmissive so that the marker may be viewed through the vessel and/or the light transmissive portion.

The identifier may be a QR code or other optical identifier that is optically visible from outside the sample collection device. The QR code may be visible through an optical window or aperture in the bottom of the base of the sample collection device. The QR code may be provided on the sample collection device base or on a portion of the vessel visible through the base. An image capture device, such as a camera or scanner, may be provided external to the sample collection device and may be capable of reading the QR code.

A single or multiple QR codes or other identifiers may be provided on the sample collection device. In some cases, each vessel may have at least one identifier, such as a QR code associated therewith. In one example, at least one window may be provided in the base for each vessel, and each window may allow a user to view a QR code or other identifier. For example, two vessels 1346a, 1346b may be housed within the base 1340, wherein each vessel has an associated identifier 1600, 1602 that is externally recognizable from the sample collection device.

The base 1340 may be separable from the stand 1330 or other portions of the sample collection device. The one or more identifiers may be separable from the remainder of the sample collection device along with the base.

In some embodiments, the identifier may be provided with a vessel received by the base. Separating the base from the remainder of the sample collection device may cause the vessel to be separated from the remainder of the sample collection device. The vessel may remain within the base or may be removable from the base. The identifier may remain with the vessel even if the vessel is removed from the base. Alternatively, the identifier may remain with the base even if the vessel is removed. In some cases, the base and the vessel may each have an identifier such that the vessel and the base may be individually tracked and/or matched even when separated.

In some cases, any number of vessels may be provided within the sample collection device. The sample vessel may be capable of receiving a sample from a subject. Each sample vessel may have a unique identifier. The unique identifier can be associated with any information relating to the sample, subject, device, or component of the device.

In some cases, each identifier for each vessel may be unique. In other embodiments, the identifier on the vessel need not be unique, but may be unique to the device, to the subject, or to the sample type.

The sample collection device can receive a sample from a subject. The subject may directly contact the sample collection device or provide the sample to the device. The sample may travel through the device to one or more vessels within the device. In some cases, the sample may be processed before it reaches the vessel. One or more coatings or substances may be provided within the sample collection unit and/or channels that may deliver the sample to the vessel. Alternatively, no treatment is provided to the sample before it reaches the vessel. In some embodiments, the sample may or may not be processed within the vessel. In some cases, the sample may be provided with a plurality of different types of processing before or while the sample reaches the vessel. The treatments may be provided in a pre-selected order. For example, a first process is desired first, and may be provided upstream of a second process. In some cases, the sample is not processed at any point.

In some embodiments, the sample may be a blood sample. The first vessel may receive whole blood and the second vessel may receive plasma. An anticoagulant may be provided along the fluid path and/or in the vessel.

Once the vessel has been provided with the sample and sealed, the vessel may be shipped to a separate location for sample analysis. The separate location may be a laboratory. The separate location may be a remote facility relative to the sample collection site. The entire sample collection device may be sent to a separate location. One or more identifiers may be provided on the sample collection device and may be used to identify the sample collection device and/or vessels therein. Alternatively, the base 1340 may be removed from the sample collection device and may be sent to a separate location with the vessels therein. One or more identifiers may be provided on the base and may be used to identify the base and/or vessels therein. In some cases, the vessel may be removed from the base and may be sent to a separate location. One or more identifiers may be provided on each vessel and may be used to identify the vessel.

The identifier may be read by any suitable technique. By way of example and not limitation, in some cases, the markers are read using an optical detector, such as an image capture device or a barcode scanner. In one example, an image capture device may capture an image of a QR code. Information about the vessel can be tracked. For example, when a vessel arrives at a location, the identifier may be scanned and a record of the arrival of the vessel may be kept. The progress and/or location of the vessel may be actively and/or passively updated. In some cases, it may be desirable to intentionally scan the identifier in order to determine the location of the vessel. In other examples, the identifier may actively emit a signal that may be picked up by a signal reader. For example, the signal reader may track the location of the identifier as it passes through a building.

In some cases, reading the identifier may allow a user to obtain additional information associated with the identifier. For example, a user may use some means to capture an image of the identifier. The device or another device may display information about the sample, the subject, the device, the components of the device, or any other information described elsewhere herein. Information about the tests to be performed and/or the test results may be included. The user may perform subsequent tests or actions on the sample based on the information associated with the identifier. For example, a user may guide the vessel to an appropriate location for detection. In some cases, the vessels can be guided to the appropriate location and/or the contents of the vessels can be subjected to appropriate sample processing (e.g., sample preparation, assay, detection, analysis) in an automated manner without human intervention.

Information regarding the sample processing can be collected and correlated to the identifier. For example, if the vessel has an identifier and sample processing has been performed on the contents of the vessel, one or more signals generated in response to the sample processing may be stored and/or associated with the identifier. Such updating can be done in an automated manner without human intervention. Alternatively, the user may initiate the storage of the information, or may manually enter the information. Thus, medical records about a subject can be aggregated in an automated fashion. The identifier can be used to index and/or access information about the subject.

Sample vessel

Fig. 18A-18B illustrate non-limiting examples of sample vessels 1800 according to embodiments described herein, the sample vessels 1800 being usable with a sample collection device. In some cases, the sample vessel may be supported by a sample collection device. Alternatively, the sample vessel may be contained or surrounded by a portion of the sample collection device. In one example, the sample collection device may have a first configuration in which the sample vessel is fully enclosed. A second configuration may be provided in which the sample collection device may be open and may expose at least a portion of the sample vessel. In some examples, the sample vessel may be supported by and/or at least partially enclosed by a holder of the sample collection device. The holder may be separable from the remainder of the sample collection device, thereby providing access to the sample vessels therein.

In the case of bodily fluid sample collection, sample fluid may be withdrawn from a patient using a sample collection device such as, but not limited to, those described in U.S. patent application serial No. 61/697,797 filed on 6/9/2012 and U.S. patent application serial No. 61/798,873 filed on 15/3/2013, all of which are hereby incorporated by reference in their entirety for all purposes. In a non-limiting example of a blood sample, some embodiments may collect a blood sample by collecting capillary blood from a subject. This may occur by way of a wound, penetration site, or other access site to the capillary blood from the subject. Optionally, blood may also be collected by venipuncture or other vascular puncture to obtain a blood sample for loading into one or more sample vessels. For example, blood may be collected by a device configured for small volume blood collection by venipuncture. Such a device may for example comprise a hollow needle in fluid connection or capable of being in fluid connection with a vessel having a smaller internal volume. The vessel with a smaller internal volume may have an internal volume equal to or not more than 5ml, 4ml, 3ml, 2ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 100 l, 90 l, 80 l, 70 l, 60 l, 50 l, 40 l, 30 l, 20 l, 10 l or 5 l, for example. Other types of devices and techniques for collecting body fluids are not excluded.

Bodily fluids may be drawn from a subject and provided to a device in a variety of ways, including but not limited to: finger stick, incision, injection, aspiration, wipe, pipette, phlebotomy, venipuncture, and/or any other technique described elsewhere herein. In some embodiments, a sample may be collected from the breath of a subject. A body fluid collector may be used to provide body fluid. The bodily fluid collector may include a lancet, capillary tube, pipette, syringe, needle, microneedle, pump, or any other collector described elsewhere herein. In some embodiments, the sample may be a tissue sample that may be provided from a subject. The sample may be removed from the subject or may have been discarded by the subject.

In one embodiment, the lancet penetrates the skin of the subject and extracts the sample, for example, using gravity, capillary action, suction, pressure differential, or vacuum force. The lancet or any other body fluid collector may be part of the device, part of the cartridge of the device, part of the system, or a separate component. The lancet or any other body fluid collector may be activated by a variety of mechanical, electrical, electromechanical, or any other known activation mechanisms or any combination of such methods, as desired.

In one example, a finger of a subject (or other part of the subject's body) may be pierced to obtain a body fluid. The body fluid may be collected using a capillary tube, pipette, swab, drop, or any other mechanism known in the art. The capillary or pipette may be separate from or part of the device and/or a cartridge of the device that is insertable into or attachable to the device. In another embodiment where an activation mechanism is not required, the subject may simply provide a body fluid to the device and/or cartridge, e.g., with a saliva sample.

Bodily fluids may be drawn from a subject and provided to a device in a variety of ways, including but not limited to: finger prick, incision, injection and/or pipetting. Body fluids may be collected using intravenous or non-intravenous methods. A body fluid collector may be used to provide the body fluid. The body fluid collector may comprise a lancet, capillary tube, pipette, syringe, phlebotomist, or any other collector described elsewhere herein. In one embodiment, the lancet penetrates the skin and the sample is withdrawn, for example, using gravity, capillary action, suction, or vacuum force. The lancet may be part of the device, part of a cartridge of the device, part of the system, or a separate component. The lancet may be activated by a variety of mechanical, electrical, electromechanical, or any other known activation mechanisms or any combination of such methods, as desired. In one example, a finger of a subject (or other part of the subject's body) may be pierced to obtain a body fluid. Examples of other parts of the subject's body may include, but are not limited to: the subject's hand, wrist, arm, torso, leg, foot, or neck. The body fluid may be collected using a capillary tube, pipette, or any other mechanism known in the art. The capillary or pipette may be separate from or part of the device and/or cartridge. In another embodiment where an activation mechanism is not required, the subject may simply provide a body fluid to the device and/or cartridge, for example, with a saliva sample. The collected bodily fluid may be placed within the device. The body fluid collector may be attached to the device, removably attached to the device, or may be provided separately from the device.

A sample obtained from a subject may be stored in a sample vessel 1800. In one embodiment described herein, the sample vessel 1800 includes a body 1810 and a cap 1820. In some cases, at least portions of the sample vessel body may be formed of a transparent or translucent material. The sample vessel body may allow a sample provided within the sample vessel body to be visible when viewed from outside the sample vessel. The sample vessel body may be light transmissive. The sample vessel body may be formed of a material that may allow electromagnetic radiation to pass through. In some cases, the sample vessel body may be formed of a material that may allow electromagnetic radiation of selected wavelengths to pass through, but not allow electromagnetic radiation of other, non-selected wavelengths to pass through. In some cases, a portion of the body or the entire body may be formed of a material that is opaque along a selected wavelength of electromagnetic radiation (such as a wavelength of visible light). Optionally, portions of the sample vessel body may be shaped to provide a certain optical path length. Optionally, portions of the sample vessel body may be shaped to provide flat surfaces (outer and/or inner) or other structures to allow analysis of the sample while it is in the sample vessel.

In one embodiment, open and closed ends may be provided on the sample vessel body 1810. The open end may be a top end 1812 of the sample vessel 1800, which may be at one end that may be configured for engagement with a cap. The closed end may be a bottom end 1814 of the sample vessel, which may be at an end of the sample vessel opposite the cap. In an alternative embodiment, the bottom end may also be an open end that may be closed using a bottom plate. In some embodiments, the cross-sectional area and/or shape of the top and bottom ends may be substantially the same. Alternatively, the cross-sectional area of the top end may be greater than the cross-sectional area of the bottom end, or vice versa. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the sample vessel body may have an inner surface and an outer surface. The surface of the sample vessel body may be smooth, rough, textured, faceted, shiny, dull, contain grooves, contain ridges, or have any other feature. The surface of the sample vessel body may be treated to provide the desired optical properties. The inner and outer surfaces may have the same properties or may be different. For example, the outer surface may be smooth while the inner surface is rough.

Alternatively, the sample vessel body may have a tubular shape. In some cases, the sample vessel body may have a cylindrical portion. In some cases, the sample vessel may have a circular cross-sectional shape. Alternatively, the sample vessel may have any other cross-sectional shape, which may include an ellipse, a triangle, a quadrilateral (e.g., square, rectangle, trapezoid, parallelogram), a pentagon, a hexagon, a heptagon, an octagon, or any other shape. The cross-sectional shape of the sample vessel may or may not have a convex and/or concave shape. The cross-sectional shape of the sample vessel may remain the same along the length of the sample vessel, or may vary. The sample vessel may have a prismatic shape along the length of the body. The prisms may have a cross-sectional shape as described herein.

Alternatively, the bottom 1814 of the sample vessel may be flat, tapered, rounded, or any combination thereof. In some cases, the sample vessel may have a hemispherical bottom. In other embodiments, the sample vessel may have a rounded bottom with a flat portion. The sample vessel may or may not be able to stand on its own flat surface.

In one embodiment, the sample vessel 1800 may be sized to contain a small fluid sample. In some embodiments, the sample vessel can be configured to contain no more than about 5mL, 4mL, 3mL, 2mL, 1.5mL, 1mL, 900uL, 800uL, 700uL, 600uL, 500uL, 400uL, 300uL, 250uL, 200uL, 150uL, 100uL, 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL, 1nL, 500pL, 300pL, 100pL, 50pL, 10pL, 5nL, 1nL, 500pL, 300pL, 100pL, 50pL, 10pL, 5pL, or 1 pL. By way of non-limiting example, the sample vessel may have an information storage unit thereon, such as discussed with respect to fig. 1F and 1G. In one non-limiting example, the sample vessel 100 can contain a small volume of sample fluid in liquid form without the use of wicking materials, screens, solid matrices, or the like to contain the sample fluid during transport. This allows the sample fluid to be removed from the sample vessel substantially in liquid form without loss of sample or sample integrity due to absorption of the liquid by the wicking or other material.

Alternatively, the sample vessel 1800 may be configured to contain no more than a few drops of blood, a drop of blood, or a portion of no more than a drop of blood. For example, the sample vessel may have an internal volume no greater than the amount of fluid sample it is configured to contain. Having a small volume sample vessel may advantageously allow storage and/or transport of a large number of sample vessels within a small volume. This may reduce resources used to store and/or transport the sample vessels. For example, less storage space may be required. Further, less cost and/or fuel may be used to transport the sample vessels. A greater number of sample vessels can be transported for the same amount of effort.

In some embodiments, the sample vessel 1800 may have a small length. For example, the sample vessel can be no greater than 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm, 1.1cm, 1cm, 0.9cm, 0.8cm, 0.7cm, 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 30um, or 1um in length. In some cases, the largest dimension (e.g., length, width, or diameter) of the sample vessel can be no greater than 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm, 1.1cm, 1cm, 0.9cm, 0.8cm, 0.7cm, 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 30um, or 1 um.

The sample vessel 1800 may have any cross-sectional area. The cross-sectional area may be no greater than about 16cm²、8cm²、7cm²、6cm²、5cm²、4cm²、3.5cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.9cm²、0.8cm²、0.7cm²、0.6cm²、0.5cm²、0.4cm²、0.3cm²、0.2cm²、0.1cm²、0.07cm²、0.05cm²、0.03cm²、0.02cm²、0.01cm²、0.5cm²、0.3cm²Or 0.1cm². The cross-sectional area may remain the same or may vary along the length of the sample vessel.

The sample vessel 1800 may have any thickness. The thickness may remain the same along the length of the sample vessel or may vary. In some cases, the thickness may be selected and/or may be varied to provide desired optical properties. In some cases, the thickness may be no greater than 5mm, 3mm, 2mm, 1mm, 700um, 500um, 300um, 200um, 150um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 3um, 1um, 700nm, 500nm, 300nm, or 100 nm.

In one embodiment, the sample vessel 1800 may have a shape that facilitates supporting centrifugation of small volumes of blood samples. This allows to directly bring the collected sample in the sample vessel to the centrifuge without having to further transfer the sample fluid to a further sample vessel used in the centrifuge device.

Optionally, the sample vessel may comprise a cap 1820. The cap 1820 may be configured to fit over the open end of the sample vessel. The cap may block the open end of the sample vessel. The cap may fluidly seal the sample vessel. The cap may form a fluid-tight seal with the sample vessel body. For example, the cap may be gas and/or liquid impermeable. Alternatively, the cap may allow certain gases and/or liquids to pass through. In some cases, the cap may be breathable and liquid impermeable. The cap may be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma.

Alternatively, the cap may be configured to engage with the sample vessel body in any manner. For example, the cap may be press fit with the sample vessel body. The friction fit and/or interference fit may allow the cap to rest on the body. In other examples, a locking mechanism may be provided, such as a sliding mechanism, a clamp, a fastener, or other techniques. In some cases, the cap and/or the sample vessel body may be threaded to allow for screw-type engagement. In other examples, adhesives, welding, soldering, brazing may be utilized to connect the cap to the sample vessel body. The cap may be removably attached to the sample vessel body. Alternatively, the cap may be permanently fixed to the sample vessel body.

In some cases, a portion of the cap may fit into a portion of the sample vessel body. The cap may form a stopper with the sample vessel body. In some cases, a portion of the sample vessel body may fit into a portion of the cap. The plug may comprise a flange or shelf that may be shrouded over a portion of the sample vessel body. The flange or shelf may prevent the cap from sliding into the sample vessel body. In some cases, a portion of the cap may overlie the top and/or sides of the sample vessel body. Optionally, some embodiments may include additional components in the vessel assembly, such as a cap holder. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and the sample vessel. In one embodiment, the cap holder engages an attachment, flange, recess, or other attachment location on the exterior of the sample vessel to hold the cap in place. Alternatively, some embodiments may combine the functionality of both the cap and the cap holder into one assembly.

In some embodiments, the sample vessel body may be formed of a rigid material. For example, the sample vessel body may be formed from a polymer such as polypropylene, polystyrene, or acrylic. In alternative embodiments, the sample vessel body may be semi-rigid or flexible. The sample vessel body may be formed from a single unitary piece. Alternatively, multiple parts may be used. The multiple pieces may be formed of the same material or of different materials.

Alternatively, the sample vessel cap may be formed of an elastomeric material or any other material described elsewhere herein. In some cases, the cap may be formed of rubber, polymer, or any other material that may be flexible and/or compressible. Alternatively, the cap may be semi-rigid or rigid. The sample vessel cap may be formed of a high friction material. The sample vessel cap may be friction fit to engage with the sample vessel body. When the sample vessel cap is engaged with the sample vessel body, a fluid-tight seal may be formed. The interior of the sample vessel body may be fluidly isolated from the ambient air. In some cases, at least one of the cap and/or the portion of the sample vessel body contacting the cap can be formed of a high friction and/or compressible material.

In some embodiments, cap 1820 may be a self-sealing, airtight closure penetrable by a needle and/or cannula in a sealing engagement in the open end of the sample vessel, so as to maintain a vacuum and/or a closed atmosphere within the sample vessel. In some embodiments, the interior of the sample vessel is only at a partial vacuum, not a full vacuum. Excessive vacuum may damage the formed blood components in the sample fluid. By way of non-limiting example, the partial vacuum ranges from about 50% to 60% of full vacuum. Optionally, the partial vacuum is no more than about 60% of full vacuum. Optionally, the partial vacuum is no more than about 50% of a full vacuum. Optionally, the partial vacuum is no more than about 40% of a full vacuum. By way of non-limiting example, the partial vacuum ranges from about 10% to about 90% of full vacuum, or between about 20% to about 70% or between about 30% to 60% of full vacuum. By way of non-limiting example, the partial vacuum ranges from about 10% to about 60% of full vacuum, or between about 20% to about 50% or between about 30% to 50% of full vacuum. In this way, a reduced amount of force is applied to the bodily fluid sample to minimize problems with sample integrity. Optionally, the atmosphere is at ambient pressure after sample transfer. Optionally, after sample transfer, the atmosphere is under some partial vacuum. Optionally, only one sample vessel of the plurality of sample vessels is under a partial vacuum while the other sample vessels are under a higher vacuum or under a full vacuum.

In some embodiments, cap 1820 may be a closure device with one end inside the sample vessel and the other end outside the sample vessel, where the inner end has a surface in continuous sealing contact with the sample vessel, the inner end having an annular sleeve extending from the surface towards the closed end, the annular sleeve having a first notch extending through a wall of the annular sleeve and juxtaposed with the sample vessel. In one embodiment, the closure has a recessed ring formed around a first notch of the interior end, and the serrated ring engages a protuberance of the tubular sample vessel.

Alternatively, the sample vessel cap may be formed from a single unitary piece. Alternatively, multiple parts may be used. The multiple pieces may be formed of the same material or of different materials. The cap material may be the same or different from the sample vessel body material. In one example, the sample vessel body may be formed of a light transmissive material and the cap is formed of an opaque material.

Optionally, the cap 1820 may be removably engaged with the body. A portion of the cap may be insertable into the body. The cap may include a flange, which may be located at the top of the body. The flange is not inserted into the body. In this non-limiting example, the flange may prevent the cap from being inserted entirely into the body. The flange may form a continuous flange around the cap. In some cases, a portion of the flange may overlap or overlie a portion of the body. A portion of the body may be insertable into a portion of the cap.

Alternatively, the portion of the cap that may be insertable into the body may have a rounded bottom. Alternatively, the portion may be flat, tapered, curved, wavy, or have any other shape. The cap may be shaped to be easily inserted into the body.

In some cases, a dimple may be provided at the top of the cap. The recess may follow the portion of the cap inserted into the body. In some cases, a hollow or dimple may be provided in the cap. The well may be capable of receiving a portion of a channel that may be used to deliver a sample to the sample vessel. The dimples may assist in directing the channels to a desired portion of the cap. In one example, the channel may be positioned within the well prior to bringing the channel and the interior of the sample vessel into fluid communication.

Alternatively, the channel and the cap may be pressed together such that the channel penetrates the cap and into the interior of the sample vessel, thereby bringing the channel into fluid communication with the interior of the sample vessel. In some cases, the cap may have a slit through which the passage passes. Alternatively, the channel may puncture through uninterrupted cap material. The channel may be withdrawn from the sample vessel, thereby bringing the channel out of fluid communication with the sample vessel. The cap may be capable of resealing when the passage is removed. For this example, the cap may be formed of a self-healing material. In some cases, the cap may have a slit that may close when the channel is removed, forming a fluid-tight seal.

In some embodiments, the body may include one or more flanges or other surface features. Examples of surface features may include flanges, bumps, protrusions, grooves, ridges, threads, holes, facets, or any other surface feature. The flange and/or other surface features may circumscribe the body. The flange and/or other surface features may be located at or near the top of the body. The flange and/or other surface features may be located at the top half, top third, top quarter, top fifth, top sixth, top eighth, or top tenth of the body. The surface features may be used for support of the sample vessel within the sample collection device. The surface features may be used to remove a sample vessel from the sample collection device and/or position a sample vessel within the sample collection device. The flange and/or other surface features may or may not engage the cap.

Alternatively, the cap may be of any size relative to the sample vessel body. In some cases, the cap and/or the body may have similar cross-sectional areas. 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 a smaller length than the body. For example, the cap may have a length that may be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3%, or 1% of the length of the body.

Referring now to fig. 18C-18E, further embodiments of the sample vessel 1800 may include a cap holder 1830, the cap holder 1830 fitting over the cap to secure the cap in place. By way of non-limiting example, the cap holder 1830 may also include an opening in the cap holder 1830 that allows a member, such as an adapter, to slide through and penetrate the cap 1820. Fig. 18C shows the components in an exploded view.

Fig. 18D shows a cross-sectional view illustrating an embodiment in which the sample vessel body 1810 has a cap 1820 covered by a cap holder 1830. As seen in fig. 18D, the cap holder 1830 has a locking feature 1832 for securing the cap holder 1830 to the sample vessel body 1810 and/or the cap 1820. In one embodiment, the locking feature 1832 comprises an internal ridge that will engage one or more of the ridges 1812 and 1814 on the sample vessel body 1810. Fig. 18E shows a side view of the cap holder 1830 coupled to the sample vessel body 1810.

In some cases, the surface (inner and/or outer) of the sample vessel may be coated or treated with a material. For example, the interior surfaces of the sample vessel may be coated with fixatives, antibodies, optical coatings, anticoagulants, sample additives, and/or preservatives. These may be the same or different from any of the material coatings in the channels. In one non-limiting example, the coating may be, but is not limited to: polytetrafluoroethylene, parylene, polysorbate surfactants (e.g., polysorbate 20), or other materials as a treatment to the surface to reduce surface tension.

In embodiments, the sample vessel may comprise a blood coagulation activator (e.g., thrombin, silica particles, glass particles), an anti-glycolytic agent (e.g., sodium fluoride), or a gel to facilitate separation of blood cells from plasma. In an example, the sample vessel may comprise Sodium Polyanthranilate (SPS), an acid citrate glucose additive, perchloric acid, or sodium citrate. Some embodiments may include at least one material from each of the above groupings. Alternatively, it is also understood that other additives or materials are not excluded, in particular if the additives do not interfere with each other in terms of function.

Optionally, a coating is applied on all inner surfaces of the sample vessel. Alternatively, some embodiments may apply the coating in a pattern that covers only selected areas in the sample vessel. Some embodiments may cover only the upper interior region of the sample vessel. Alternatively, some embodiments may cover only the lower interior region of the sample vessel. Alternatively, some embodiments may cover strips, lines, or other geometric patterns of the interior region of the sample vessel. Optionally, some embodiments may also coat the surface of the cap, plug, or coat a cover used with the sample vessel. Some embodiments may coat the surface of the sample vessel from which the sample enters to provide a smooth transition of the sample away from the entry area and toward a destination point (such as, but not limited to, a bottom portion of the vessel).

Alternatively, the coating may be a wet coating or a dry coating. Some embodiments may have at least one dry coating and at least one wet coating. In some cases, one or more reagents may be coated and dried on the inner surface of the sample vessel. The coating may alternatively be provided in a moist environment or may be a gel. Some embodiments may include a separation gel in the sample vessel to keep selected portions of the sample away from other portions of the sample. Some embodiments may include serum separation gels and plasma separation gels, such as, but not limited to, polyester-based separation gels commercially available from Becton Dickinson.

Optionally, one or more solid matrices may be provided within the sample vessel. For example, one or more beads or particles may be provided within the sample vessel. The beads and/or particles may be coated with reagents or any other substance described herein. The beads and/or particles may be capable of dissolving in the presence of the sample. The beads and/or particles may be formed from one or more reagents, or may aid in processing the sample. The reagent can be provided in gaseous form within the sample vessel. The sample vessel may be sealed. The sample vessel may remain sealed prior to introducing the sample into the sample vessel, after the sample has been introduced into the sample vessel, and/or while the sample is introduced into the sample vessel. In one embodiment, the sample vessel may have a smooth surface and/or a rounded bottom. This helps to minimize stress on the blood sample, especially during centrifugation. Of course, in alternative embodiments, other shapes of the bottom of the sample vessel are not excluded.

In embodiments, the bodily fluid sample in the sealed sample vessel may retain dissolved gas in the bodily fluid sample such that the sample stored in the sealed sample vessel retains a dissolved gas composition similar to or the same as a bodily fluid sample freshly drawn from the body of the subject or a sample freshly prepared from a different sample (e.g., freshly prepared plasma from whole blood). In embodiments, the bodily fluid sample in the sealed sample vessel may retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the dissolved gas over a time 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. Typically, in such embodiments, the time period begins when the sample is placed into the sample vessel or when the sample vessel is sealed. To facilitate retention of dissolved gases in a bodily fluid sample, the sample may be stored in a sealed sample vessel at a selected temperature, e.g., 20 ℃, 15 ℃, 10 ℃, 4 ℃, or the like, or at a freezing temperature below 0 ℃. Other temperatures for sample storage are not excluded.

Similarly, in embodiments, the bodily fluid sample in the sealed sample vessel may retain an analyte in the bodily fluid sample, such that the sample stored in the sealed sample vessel retains an analyte composition similar to or the same as a freshly drawn bodily fluid sample or a freshly prepared bodily fluid sample from the body of the subject (e.g., freshly prepared plasma from whole blood). In embodiments, the bodily fluid sample in the sealed sample vessel may retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the analyte over 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, or 48 hours. Typically, in such embodiments, the time period begins when the sample is deposited into the sample vessel or when the sample vessel is sealed. To facilitate retention of one or more analytes in a bodily fluid sample, the sample may be stored in a sealed sample vessel at a selected temperature, e.g., 20 ℃, 15 ℃, 10 ℃, 4 ℃, etc., or at a freezing temperature below 0 ℃. Other temperatures for sample storage are not excluded. Optionally, the sample vessel may be centrifuged after introducing the sample into the vessel. For example, the sample vessel may be centrifuged within 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 7 days, or 10 days of sample introduction into the vessel. For example, in the case of a whole blood sample, centrifuging the sample vessel containing the sample may facilitate separation of blood cells from plasma to obtain plasma and precipitated cells. In some cases, centrifuging the sample improves the stability of one or more analytes in blood or plasma.

Fig. 18F further illustrates that the sample vessels may each have at least one information storage unit associated with the sample vessel. Optionally, some embodiments may have one information storage unit to communicate information about multiple sample vessels, particularly if (but not limited to) the sample vessels all contain samples from the same subject. Such an information storage unit may be located on a carrier holding a plurality of sample vessels, rather than on the sample vessels themselves.

Fig. 18F shows a bottom view of the bottom surface of one of the sample vessels, in one non-limiting example, the information storage unit 1860 may be at least one of: a barcode (e.g., 1-D, 2-D, or 3-D), a Quick Response (QR) code, an image, a shape, a word, a number, an alphanumeric string, a color, or any combination thereof, or any type of visual information storage unit. Other embodiments may use information storage units that are not in the visible spectrum. Other embodiments may use RFID tags, RF information storage units, IR luminescent tags, or other markers that do not rely on authentication by signals transmitted through the visible spectrum. Of course, the information storage unit 1860 may also be positioned on the top surface of the sample vessel. Fig. 18G shows that optionally, an information storage unit 1860 may also be included on the side surface of the sample vessel. This may be in addition to or in place of one or more information storage units 1860 positioned top or bottom.

In one non-limiting example, the information storage unit 1860 can be used to identify samples and/or sample types in a sample collection device. Optionally, there may be one or more information storage units per sample vessel. Some embodiments may also use an information storage unit on the sample vessel holder. The sample storage unit may identify the sample collection device, one or more individual sample vessels 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 sample vessel may be transported. In one example, the sample collection device or portions of the sample collection device may be transported via a delivery service or any other service described elsewhere herein. The sample vessel may be delivered such that one or more assays may be performed on the sample.

Alternatively, the identity of the sample and/or the identity of the individual providing the sample may be tracked. By way of non-limiting example, information associated with one or more individuals providing the sample (e.g., name, contact information, social security number, date of birth, insurance information, billing information, medical history) and other information of the sample provider may be included. In some cases, the type of sample (e.g., whole blood, plasma, urine, etc.) may be tracked. Optionally, the type of reagent (e.g., anticoagulant, marker, etc.) that the sample will encounter may also be tracked. Additional information regarding sample collection may be considered, such as date and/or time of collection, environment in which the sample was collected, type of test to be performed on the sample, one or more settings for the test, a test protocol, insurance information, medical record information, or any other type of information.

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

Alternatively, the information storage unit may provide a unique identification, or may provide a high probability of providing a unique identification. In some cases, the information storage unit may have a visual component. The information storage unit may be optically detectable. In some cases, the information storage unit may be identifiable using visible light. In some examples, the information storage unit may be a barcode (e.g., 1-D, 2-D, or 3-D), a Quick Response (QR) code, an image, a shape, a word, a number, an alphanumeric string, a color, or any combination thereof, or any type of visual information storage unit.

In other embodiments, the information storage unit may be optically detectable via any other kind of radiation. For example, the information storage unit may be detectable via infrared, ultraviolet, or any other type of wavelength of the electromagnetic spectrum. The information storage unit may utilize luminescence, such as fluorescence, chemiluminescence, bioluminescence, or any other type of light emission. In some cases, the information storage unit may be a radio transmitter and/or receiver. The information storage unit may be a Radio Frequency Identification (RFID) tag. The information storage unit may be any type of wireless transmitter and/or receiver. The information storage unit may transmit one or more electrical signals. In some cases, a GPS or other location-related signal may be used with the information storage unit.

Optionally, the information storage unit may be and/or comprise an audio component or an acoustic component. The information storage unit may emit a sound that may be recognizable to uniquely identify the identified component.

Alternatively, the information storage unit may be detectable via optical detection means. For example, a barcode scanner may be capable of reading the information storage unit. In another example, a camera (e.g., a camera for still images or video images) or other image capture device may be capable of capturing an image of the information storage unit and analyzing the image to determine the identity.

Alternatively, the information storage unit may be located on the holder of one or more sample vessels. One or more recesses may be provided in the holder. An information storage unit may be located within the recess. The recess may be located on a bottom surface or a side surface of the holder. In some embodiments, the retainer may include one or more protrusions. The information storage unit may be located on the protrusion. In some cases, the information storage unit may be provided on an outer surface of the holder. The information storage unit may alternatively be positioned on the inner surface of the holder. The information storage unit may be detectable from outside the sample collection device.

In some embodiments, the information storage unit may be located on an outer surface of the sample vessel or on an inner surface of the sample vessel. The information storage unit may be detectable from outside the sample vessel. In some embodiments, the information storage unit may be provided on a bottom surface of the sample vessel.

In one non-limiting example, the retainer can include a light transmissive portion. The light transmitting portion may be located on a bottom of the holder or a side of the holder. For example, a transparent or translucent window may be provided. In another example, the light transmissive portion may be a hole without a window. The light transmitting portion may allow a portion within the holder to be visible. The information storage unit may be provided on an outer surface of the holder on the light transmitting portion, on an inner surface of the holder but visible through the light transmitting portion, or on an outer or inner surface of the sample vessel but visible through the light transmitting portion. In some cases, the information storage unit may be provided on an inner surface of the sample vessel, but the sample vessel may be light transmissive so that the information storage unit may be viewed through the sample vessel and/or the light transmissive portion.

Alternatively, the information storage unit may be a QR code, a barcode, or other optical information storage unit that may be optically visible, such as but not limited to, from outside the sample collection device. The QR code may be visible through an optical window, hole, etc. in 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 vessel that is visible through the holder. An image capture device, such as a camera or scanner, may be provided outside of the sample vessel or transport container and may be capable of reading 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 vessel may have at least one information storage unit, such as a QR code associated therewith. In one example, at least one window may be provided in the holder for each sample vessel, and each window may allow a user to view a QR code or other information storage unit. For example, two sample vessels may be housed within a holder, each of the sample vessels having an associated information storage unit that is identifiable from outside the holder.

In some embodiments, the information storage unit may be provided with a sample vessel received by the holder. Separating the holder from the remainder of the sample collection device may cause the sample vessel to be separated from the remainder of the sample collection device. The sample vessel may remain within the holder or may be removable from the holder. The information storage unit may remain with the sample vessel even if the sample vessel is removed from the holder. Alternatively, the information storage unit may remain with the holder even if the sample vessel is removed. In some cases, the holder and the sample vessel may each have an information storage unit, such that the sample vessel and the holder may be individually tracked and/or matched even when separated.

In some cases, any number of sample vessels may be provided within the sample collection device. Some embodiments may connect all of these sample vessels to the sample collection device all at once. Alternatively, the sample vessels can be coupled in a sequential manner or other non-simultaneous manner. The sample vessel may be capable of receiving a sample received from a subject. Each sample vessel may optionally have a unique information storage unit. The unique information storage unit may be associated with any information relating to the sample, subject, device, or component of the device.

In some cases, each information storage unit of each sample vessel may be unique, or contain unique information. In other embodiments, the information storage unit on the sample vessel need not be unique. Optionally, some embodiments may have information that is unique to the device, to the subject, and/or to the sample type. In some embodiments, the information on the information storage unit may be used to associate several sample vessels with the same subject or the same information.

In some embodiments, the information storage unit is attached to or otherwise associated with (physically or through non-physical association such as a database pointer or link) the sample vessel or group of sample vessels at the time the appointment is collected. If associated by group, the association may be based on all being from the same user or other factors as set forth herein. Alternatively, some embodiments may already have an information storage unit on the sample vessel or group of sample vessels. In one non-limiting example, the information storage unit provides identifier information that is then associated with the subject at or near the time of sample collection. In this example, the information on the information storage unit remains unchanged but is then linked to the subject. In another embodiment, the information on the information storage unit is changed to include information about the subject. Alternatively, some embodiments may both, with some information being changed and some information being unchanged (but may then be associated with the subject or other information about the collection event, such as the time and date).

With reference to fig. 19A-19C, various embodiments of the front end of the sample collection device will now be described. Fig. 19A shows a top view of the front end of a sample collection device with openings 1103 and 1105 for their respective channels. In this embodiment, the openings 1103 and 1105 are placed in close proximity to each other with a separation wall 1910 between the openings 1103 and 1105. In one non-limiting example, the thickness of the separation wall 1910 is set to a minimum thickness that can be reliably formed by 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 a side-by-side configuration, the openings 1103 and 1105 may be in an up-down configuration, a diagonal configuration, or other configuration in which two openings are in close proximity to each other.

Referring now to fig. 19B, this embodiment shows openings 1910 and 1912 configured to be coaxial with respect to each other. Such coaxial configuration of openings 1910 and 1912 allows for greater overlap between the two openings.

Referring now to fig. 19C, this embodiment is similar to the embodiment of fig. 19B, except that these openings 1920 and 1922 are circular, rather than square openings. It should be understood that any of a variety of shapes may be used, including but not limited to circular, elliptical, triangular, quadrilateral (e.g., square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. Of course, it should be understood that different shapes may be used for each opening, and that the collecting device need not have the same cross-sectional shape for all openings. Some embodiments may have one cross-sectional shape for the opening, but a different cross-sectional shape for the channel downstream of the opening.

Single-channel sample collection device

Referring now to fig. 20A-20B, although embodiments herein are generally described as sample collection devices having two separate channels, it should be understood that some embodiments may use a single access channel 2010. The single access channel 2010 may or may not be coated. Suitable coatings include, but are not limited to, anticoagulants, plasmas, or other materials.

Fig. 20A illustrates that in this embodiment of sample collection device 2000, tissue penetrating members 2112 may be mounted coaxially within a single access passage 2010. This allows a wound to be formed at the target tissue in a manner that will align with the single access passage 2010. The tissue penetrating member 2012 can be activated by one of a variety of techniques such as, but not limited to, being actuated upon depression of a trigger, being actuated upon contact of the device's leading end with the target tissue, or being actuated by pressure once the device is pressed against the target tissue with sufficient pressure. After actuation, the tissue penetrating member 2012 may remain in the single access passage 2010. Alternatively, the tissue penetrating member 2012 may be retracted from the single access passage 2010.

The sample fluid entering the sample collection device 2000 may be split from a single entry path 2010 into two or more separate paths 2014 and 2016. This enables the sample fluid to be separated into at least two portions from the sample collected at a single point of contact. The two portions may optionally be retained in two separate retention cells 2018 and 2020. These chambers may each have one or more adapter channels 2022 and 2024 to transfer the sample fluid to vessels such as, but not limited to, vessels 1146a and 1146 b. It should be understood that the holding chambers 2018 and 2020 and/or the vessels 1146a and 1146b may contain anticoagulants therein to prepare the sample fluid for processing.

Referring now to fig. 20B, this embodiment illustrates a single access pathway 2010 having a tissue penetrating member 2012 therein, the tissue penetrating member 2012 being configured to remain wholly or partially within the single access pathway 2010 after actuation. It should be understood that this embodiment may use a solid penetrating member or a hollow penetrating member having a lumen therein.

Referring to fig. 21, yet another embodiment of a sample collection device 2030 will now be described. This embodiment shows a single access pathway 2032 having a reduced length of tissue penetrating member 2012, with the tissue penetrating member 2012 configured to extend outwardly from pathway 2032. After actuation, tissue penetrating member 2012 may be located in pathway 2032 or, alternatively, retracted out of pathway 2032. Sample fluid entering the sample collection device 2030 may be split from a single entry pathway 2032 into two or more separate pathways 2034 and 2036. This enables the sample fluid to be separated into at least two portions from the sample collected at a single point of contact. This embodiment shows passageways 2034 and 2036 remaining in a capillary channel configuration and not expanding to become chambers, such as the embodiment of fig. 20A-20B. It should be understood that any of the embodiments herein may include one or more fill indicators for the collection pathway and/or vessels on the device so that the user may know when a sufficient fill level has been reached.

It should be appreciated that due to the small sample volume collected with vessels such as, but not limited to, vessels 1146a and 1146b, "pull" from the reduced pressure (such as, but not limited to, vacuum pressure) in the vessels is minimally transferred or not transferred into the subject in a manner that may collapse or deleteriously remodel the blood vessel or other lumen from which the sample fluid is collected. For example, pediatric and geriatric patients often have small and/or fragile veins that may collapse when using conventional large volume vacuum containers due to the higher vacuum forces associated with drawing larger sample volumes into those conventional vessels. In at least one embodiment of the device, it will not have such problems because it will not apply a vacuum (suction) force to the vein. In one embodiment, the amount of vacuum force draws no more than 120uL of sample fluid into the vessel 1146 a. Optionally, the amount of vacuum force draws no more than 100uL into the vessel 1146 a. Optionally, the amount of vacuum force draws no more than 80uL into the vessel 1146 a. Optionally, the amount of vacuum force draws no more than 60uL into the vessel 1146 a. Optionally, the amount of vacuum force draws no more than 40uL into the vessel 1146 a. Optionally, the amount of vacuum force draws no more than 20uL into the vessel 1146 a. In one embodiment, this type of aspiration is performed without the use of a syringe and is based primarily on the pulling force from the vessel and any force from the fluid exiting the subject. Alternatively, a shaped pathway through the device to draw up sample that has reached the interior of the device may assist in reducing force transmission from the vessels 1146a and 1146b to the blood vessel or other body cavity of the subject. Some embodiments may use about three-quarters of a vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent vessel collapse in the subject. Some embodiments may use about a half vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent vessel collapse in the subject. Some embodiments may use about a quarter vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent vessel collapse in the subject. The vacuum herein is a complete vacuum relative to atmospheric pressure.

It will be appreciated that in one embodiment, the cross-sectional area of the chamber in the device is greater than the cross-sectional diameter of the needle and/or flexible tubing used to draw bodily fluids from the subject. This further assists in reducing the force transmission to the subject. The vacuum pull from the vessel most directly draws the liquid sample in the device and not directly the sample in the needle that is closer to the subject. The longer access is buffered by the larger volume chamber in the collection device, which inhibits pull on the blood vessels in the subject. Furthermore, the initial peak pull force in the small volume vessel is greatly reduced relative to the larger volume vessel, which is also under vacuum. The duration of the "pull" will also be longer to allow a greater amount of sample to enter the vessel. In the smaller volume, a significant portion of the sample to be collected is already in the device, and there is less sample drawn from the subject that is not already in the device before sample pull is initiated.

Referring to fig. 22, yet another embodiment of a sample collection device will now be described. This embodiment shows a collection device 2100 having a connector 2102, such as, but not limited to, a Luer connector (Luer connector), which allows connection to a variety of sample collection devices, such as tissue penetrating members, needles, and the like. Some luer connectors may use a press fit to engage other connectors, while some embodiments of the connector 2102 may include threads to facilitate engagement. Fig. 22 shows that in this current embodiment, the butterfly needle 2104 is coupled to a fluid connection passage 2106, such as, but not limited to, a flexible tube leading to a connector 2108, to connect the sample collection feature to the sample collection device 2100. The flexible conduit 2106 allows the needle portion 2104 to be positioned away from the sample collection device 2100 but still be operatively fluidly coupled to the sample collection device 2100. This allows for greater flexibility in the positioning of the needle 2104 to collect sample fluid without having to also move the sample collection device 2100. Alternatively, some embodiments may directly couple the tissue penetrating member to the device 2100 without the use of a flexible conduit.

At least some or all embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, that shows when a sample is present within the collection device and thus indicates that engaging one or more sample vessels is acceptable. Optionally, embodiments without a fill indicator are not excluded. Some embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample. In most embodiments, one or more filled sample vessels can be disconnected from the sample collection device after a desired fill level is reached. Optionally, one or more additional sample vessels may be coupled to the sample collection device to collect additional amounts of bodily fluid sample. Optionally, the internal conditions of the sample vessel are such that the vessel has a reduced pressure, thereby being configured for aspirating only a predetermined amount of sample fluid.

Fig. 23 shows an exploded view of one embodiment of a sample collection device 2100. In this non-limiting example, portion 1130 may be configured to hold both vessel holder 1140 and the portion with sampling device holder 2160. The apparatus 2100 may include a leak-proof means 2162, which leak-proof means 2162 may engage the open ends of the dispenser channels 2022 and 2024 to minimize sample loss through the open ends until the vessels in the holder 1140 are engaged to draw sample into any one or more of the vessels therein. In the current embodiment, the leak prevention means 2162 covers at least two adapter channels 2022 and 2024 and is configured to be removable. The present embodiment of the leak prevention means 2162 is sized such that it can be moved to expose the openings on the adapter channels 2022 and 2024 while still allowing the adapter channels 2022 and 2024 to engage one or more vessels in the holder 1140.

Referring now to fig. 24 and 25, one embodiment of a sampling device holder 2160 is shown in greater detail. Fig. 24 illustrates the sampling device holder 2160 as an assembled unit. Fig. 25 illustrates an exploded view of a sampling device holder 2160 having a first portion 2164 and a second portion 2166. Adapter passages 2022 and 2024 are also shown as being removable from second portion 2166. While the present embodiment of the sampling device holder 2160 is shown as two separate portions, it should be understood that some alternative embodiments may configure the sample device holder 2160 as a single, integral unit. Optionally, some embodiments may be configured to have more than two portions that are assembled together to form the retainer 2160. Optionally, some embodiments may create separate portions along the longitudinal axis 2165 or other axis of the retainer 2160, rather than along the transverse axis of the retainer 2160, as illustrated by the cut lines in fig. 25.

Referring now to fig. 26-28, various cross-sectional views of embodiments of a sample device holder 2160 and a device 2100 are shown. Fig. 26 shows a cross-sectional view of portion 2164 and portion 2166. While not being bound by any particular theory, the use of separate portions 2164 and 2166 may be selected to simplify manufacturing, particularly for forming the various internal passages and chambers in the retainer 2160. For example, at least one wall 2167 of the chamber may be formed in the first portion 2164, while a complementary wall 2168 of the chamber may be formed in the second portion 2166. FIG. 27 shows a top end view of portion 2166 from which wall 2168 can be seen.

Referring to fig. 28, a cross-sectional view of the assembly device 2100 will now be described. This figure 28 shows that a sample entering the device through connector 2102 will enter common chamber 2170 before passing to adapter channels 2022 and 2024. From the adapter channels 2022 and 2024, movement of the retainer 1140 in the direction indicated by arrow 2172 will operatively fluidically couple the vessels 1146a and 1146b to the adapter channels 2022 and 2024, thereby moving the sample from the channels into the vessels. In this embodiment, there is sufficient space 2174 to allow movement of the vessels 1146a and 1146b to cause the adapter channels 2022 and 2024 to penetrate the caps of the vessels 1146a and 1146b so that the adapter channels 2022 and 2024 are in fluid communication with the interiors of the vessels 1146a and 1146 b. Although only two sets of vessels and adapter channels are shown in the figures, it should be understood that other configurations having more or fewer sets of vessels and adapter channels may also be configured for use with devices such as that shown in fig. 28.

Modular sample collection device

Referring now to fig. 29A-29C, while embodiments herein generally describe the sample collection device as having an adapter channel for connecting the sample collection channel with the vessel, it should be understood that embodiments without such a configuration are not excluded.

By way of non-limiting example in fig. 29A, some embodiments may not have a separate, discrete adapter channel, as previously set forth herein. Here, the collection passage 2422 may be directly connected to the vessel 2446 by way of relative movement between one or both of these elements as indicated by arrow 2449.

By way of non-limiting example in fig. 29B, the one or more adapter passages 2454 can be discrete elements that are not initially in direct fluid communication with either the collection passage 2422 or the vessel 2446. Here, the collection channel 2422 can be connected to the vessel 2446 by way of relative motion (sequentially or simultaneously) between one or more of the collection channel, the one or more adapter channels 2454, or the vessel 2446 to create a fluid pathway from the collection channel through the one or more adapter channels into the vessel.

By way of non-limiting example in fig. 29C, one or more adapter passages 2454 can be the elements that initially make contact with the vessel 2446. The adapter passage 2454 may not be in direct communication with the interior of the vessel. Here, the collection channel 2400 may be connected to the vessel by way of relative movement (sequentially or simultaneously) between one or more of those elements to create a fluid pathway from the collection channel through the one or more adapter channels into the vessel. Some embodiments may have a septum, sleeve with vent holes or cover 2455 on the end of the collection channel that will be engaged by the adapter channel. Engagement of the various elements may also move the adapter passage 2454 into the interior of the vessel 2446, as initially the adapter passage 2454 may not be in fluid communication with the interior. Some embodiments herein may have more than one adapter channel, and some embodiments may use adapter channels with sharp ends at both ends of the channel. Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

It should be understood that any of the embodiments herein may be modified to include the features set forth in the description for fig. 29A-29C.

Sample processing

Referring to FIG. 30, one embodiment of a bodily fluid sample collection and transport system will now be described. Fig. 30 shows a body fluid sample B on the skin surface S of a subject. In the non-limiting example of fig. 30, bodily fluid sample B may be collected by one of a variety of devices. By way of non-limiting example, the collection device 1530 may be, but is not limited to, those described in U.S. patent application serial No. 61/697,797 filed on 9/6/2012, which is incorporated herein by reference in its entirety for all purposes. In this embodiment, bodily fluid sample B is collected by one or more capillary channels and then directed into sample vessel 1540. By way of non-limiting example, at least one of the sample vessels 1540 may have an interior that is initially under a partial vacuum for drawing the bodily fluid sample into the sample vessel 1540. Some embodiments may simultaneously draw a sample from the sample collection device into the sample vessel 1540 from the same or different collection lanes in the sample collection device. Alternatively, some embodiments may draw the sample into the sample vessel simultaneously.

In this embodiment, after the bodily fluid sample is within the sample vessel 1540, the sample vessel 1540 in its holder 1542 (or, alternatively, removed from its holder 1542) is loaded into the transport container 1500. In this embodiment, there may be one or more slots sized for sample vessel holders 1542, or slots for sample vessels in transport container 1500. By way of non-limiting example, the wells may receive sample vessels in an array configuration and be oriented in a vertical or some other predetermined orientation. It should be understood that some embodiments of the sample vessels 1540 are configured such that they hold different amounts of sample in each vessel. By way of non-limiting example, this may be controlled based on the amount of vacuum force in each sample vessel, the amount of sample collected in one or more sample collection channels of the collection device, and/or other factors. Optionally, different pretreatments may also be present in the sample vessel, such as, but not limited to, different anticoagulants, and the like.

As seen in fig. 30, the sample vessel 1540 is collecting a sample at a first location (such as, but not limited to, a sample collection site). By way of non-limiting example, the bodily fluid sample is then transported in the transport container 1500 to a second location, such as, but not limited to, a receiving site, such as, but not limited to, an analysis site. The method of transportation may be by courier, postal express, or other transportation techniques. In many embodiments, transport may be achieved by having a further vessel in which the transport container is housed. In one embodiment, the sample collection site may 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.

Although the present embodiment of fig. 30 shows the collection of a bodily fluid sample from the surface of a subject, other alternative embodiments may use collection techniques for collecting samples from other areas of a subject, such as by venipuncture, to fill one or more sample vessels 1540. Such other collection techniques are not excluded for use as an alternative to or in conjunction with surface collection. The surface collection may be on an external surface of the subject. Alternatively, some embodiments may be collected from surfaces accessible within the body of the subject. The presence of body fluid sample B on these surfaces may occur naturally or may occur through wound creation or other techniques that make the body fluid surface accessible.

Referring now to fig. 31, described herein is yet another embodiment in which a sample of bodily fluid may be collected from within a subject as opposed to collecting the sample pooled on the surface of the subject. This embodiment of fig. 31 shows a collection device 1550 having a hypodermic needle 1552, the hypodermic needle 1552 being configured for collecting a bodily fluid sample, such as, but not limited to, venous blood. In one embodiment, the bodily fluid sample may fill a chamber 1554 in the device 1550, at which time one or more sample vessels 1540 may be engaged to draw the sample into the respective one or more vessels. Alternatively, some embodiments may not have a chamber 1554, but rather have very little empty space in addition to one or more channels, one or more passageways, or one or more tubes for directing samples from the needle 1552 to one or more sample vessels 1540. For a bodily fluid sample such as blood, the pressure from within the blood vessel is such that the blood sample can fill chamber 1554 without much, if any, assistance from the collection device. Such embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape as the channels in the collection device are filled with sample. Alternatively, some embodiments may have a direct needle attachment to the collection device 1550 (rather than a tubing connection to the needle), similar to that shown in fig. 44, where the needle is rigidly or substantially rigidly connected to the collection device. Some embodiments may have a removable connection, a releasable connection, a Luer connection, a threaded connection, or other needle connection techniques that may be developed in the future.

At least some or all embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, that shows when a sample is present within the collection device and thus indicates that engaging one or more sample vessels 1540 is acceptable. Optionally, embodiments without a fill indicator are not excluded. After the desired fill level is reached, one or more filled sample vessels 1540 may be disconnected from the sample collection device. Optionally, one or more additional sample vessels 1540 may be coupled to the sample collection device 1550 (or 1530) to collect additional amounts of bodily fluid sample.

Service point system

Referring now to FIG. 32, it should be understood that the processes described herein may be performed using automated techniques. The automated process may be used in an integrated, automated system. In some embodiments, this may be a single instrument having multiple functional components therein and surrounded by a common housing. Treatment techniques and methods for sedimentation measures can be preset. Alternatively, it may be based on a scheme or program that can be dynamically changed in the manner described in U.S. patent application Ser. Nos. 13/355,458 and 13/244,947, each of which is incorporated herein by reference in its entirety for all purposes.

In one non-limiting example as shown in fig. 32, the integrated instrument 2500 may be equipped with a programmable processor 2502, which may be used to control the components of the instrument. For example, in one embodiment, the processor 2502 may control a single or multiple pipette system 2504 that is movable in the X-Y and Z directions as indicated by arrows 2506 and 2508. The same processor or a different processor may also control other components 2512, 2514, or 2516 in the instrument. In one embodiment, the type of component 2512, 2514, or 2516 comprises a centrifuge.

As seen in fig. 32, control by processor 2502 may allow pipette system 2504 to collect a blood sample from cartridge 2510 and move the sample to one of components 2512, 2514, or 2516. Such movement may involve dispensing a sample into a removable vessel in the cartridge 2510 and then transporting the removable vessel to one of the components 2512, 2514, or 2516. Alternatively, the blood sample is dispensed directly into a vessel that has been mounted on one of the components 2512, 2514, or 2516. In one non-limiting example, one of these components 2512, 2514, or 2516 may be a centrifuge with an imaging configuration to allow illumination and visualization of the sample in the vessel. Other components 2512, 2514, or 2516 perform other analysis, measurement, or detection functions.

All of the foregoing may be integrated within a single housing 2520 and configured for countertop or small footprint floor mounting. In one example, a small footprint floor mounted system may occupy about 4m²Or a smaller floor area. In one example, a small footprint floor mounted system may occupy about 3m²Or a smaller floor area. In one example, a small footprint floor mounted system may occupy about 2m²Or a smaller floor area. In one example, a small footprint floor mounted system may occupy about 1m²Or a smaller floor area. In some embodiments, the instrument footprint may be less than or equal to about 4m²、3m²、2.5m²、2m²、1.5m²、1m²、0.75m²、0.5m²、0.3m²、0.2m²、0.1m²、0.08m²、0.05m²、0.03m²、100cm²、80cm²、70cm²、60cm²、50cm²、40cm²、30cm²、20cm²、15cm²Or 10cm². Some suitable systems in a point-of-service environment are described in U.S. patent application Ser. Nos. 13/355,458 and 13/244,947, which are all hereby incorporated by reference in their entirety for all purposes. The present embodiments may be configured for use with any of the modules or systems described in these patent applications.

With reference to fig. 33-37, a further embodiment of a sample collection device will now be described. As seen in fig. 33 and 34, at least one embodiment shows a sample collection region 2600 with a capillary channel region and, in turn, a lower flow resistance region 2610, the lower flow resistance region 2610 increasing the cross-sectional area of the channel to provide a lower flow resistance and increased flow rate. In at least one embodiment, the lower flow resistance region 2610 is still a capillary channel, but is a capillary channel with a lower flow resistance. Alternatively, other embodiments may increase in size, wherein the sample flows therein, but not under capillary action. The increased size of the channel may also be used to store samples therein. By way of non-limiting example, such storage may be temporary during collection, may be longer term, such as for transport from the collection site to refrigeration, from the collection site to the receiving site, other location to location transport, or other purposes. One embodiment may be configured with caps mounted on both ends of the device so that the sample is contained therein without transfer to vessels 1146a and 1146 b.

This may also reduce the amount of adhesive material used to bond the articles together, as the bond between regions 2600 and 2610 may be located across centerline 2620. It should be understood that embodiments may have channels 2612 and 2614 as such: the channels have the same cross-sectional size and/or are configured to contain the same or substantially the same volume within the channels. Alternatively, channels 2612 and 2614 may be configured to accommodate different volumes. The same may be true for that channel as it continues into region 2610. Alternatively, some embodiments may have different sizes when in region 2610 and the same size in region 2600, or vice versa. Other size configurations are not excluded. Although the channels are shown here as straight lines, it should be understood that for any of the embodiments disclosed herein, some embodiments may have one or more curved or otherwise non-straight portions of the channels.

The other components are similar to those previously described herein with respect to the vessels 1146a and 1146b, adapter channels, frit, retainer 130, and the like. Wicking of both channels at the junction (fill time less than 6 seconds) is improved (removal of step) and blood easily enters the channels and passes through the junction area without tilting. The components may be made of PMMA, PET, PETG, etc. In this embodiment, this may provide 7.5 times faster filling of capillary channels relative to one cross-sectional size, as the increase in channel size in region 2610 will allow for easier flow into that region.

The flow resistance in region 2610 gets a fourth power reduction based on the change in channel size, as seen in the following equation:

it will be appreciated that some embodiments may be configured so that the sample may be manipulated into the storage vessel once there is a desired sample volume in one or more channels. By way of non-limiting example, such movement of the sample may be by a pulling force, a pushing force, or both. In one embodiment, the pulling force may be provided by a vessel having a vacuum therein, a vessel having a plunger or other movable surface that moves to increase the volume and draw the sample therein, or an active vacuum force. In one embodiment, the pushing force may be pressure from air or other gas provided from behind a bolus (bolus) or other fluid grouping. In embodiments, compressed gas may be applied, pressure from a cap that slides over the collection device with a seal around the device, a syringe coupled to one end and applying pneumatic pressure or other force to urge the gas forward. The force provided may be different than the motive force used to collect the sample in one or more channels. Alternatively, some embodiments may use different power in each channel. Alternatively, some embodiments may use different motive forces in the region 2600 relative to the zone 2610.

While the present teachings have been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, with respect to any of the above embodiments, it is understood that the fluid sample can be whole blood, diluted blood, interstitial fluid, a sample collected directly from a patient, a sample located on a surface, a sample after some pre-processing, and the like. One skilled in the art will appreciate that alternative embodiments may have more than one vessel, which may be operably coupled to the needle or opening of the channel in sequence to draw fluid into the vessel. Optionally, some embodiments may have vessels configured for operably coupling to the channels simultaneously. Some embodiments may integrate a lancing device or other wound creation device with a sample collection device to bring a target sample fluid to a tissue surface and then collect the sample fluid, all using a single device. By way of non-limiting example, a spring-actuated, mechanically-actuated, and/or electromechanically-actuated tissue penetrating member may be mounted to have a penetrating tip exiting from near one end of the sample collection device near the sample collection channel opening, such that the created wound site will also be along the same end of the device as the collection opening. Alternatively, the integrated device may have a collection opening on one surface of the device, and a tissue-penetrating element along the other surface. In any of the embodiments disclosed herein, the first opening of the collection channel can have a blunt shape configured to not readily pierce a person's skin.

In addition, the use of a heating patch on a finger or other target tissue may increase blood flow to the target area and thereby increase the rate at which sufficient blood or other bodily fluid may be drawn from the subject. Heating is used to raise the target tissue to about 40C to 50C. Optionally, the heat raises the target tissue to a temperature range of about 44 to 47C.

Furthermore, one skilled in the art will recognize that any of the embodiments as described herein may be applicable to the collection of sample fluid from a human, animal, or other subject. Some embodiments as described herein may also be suitable for collection of non-biological fluid samples. Some embodiments may use a vessel that is not removable from the carrier. Some embodiments may direct the fluid sample after being metered into the sample collection portion by a second motive force to a cartridge, which is then placed in an analyte or other analytical device. Alternatively, it should be understood that while many embodiments show the vessel located in the carrier, embodiments are not excluded in which the vessel is bare or not mounted in the carrier. Some embodiments may have a vessel separate from the device and brought into fluid communication only if the channel has reached a minimum fill level. For example, the vessels may be held in different locations and only accessed by a technician when a sufficient amount of blood or sample fluid is in the sample collection apparatus. At this point, the vessels may be brought into fluid communication with one or more of the channels of the sample collection device, either simultaneously or sequentially.

Further, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a size range of about 1nm to about 200nm should be interpreted to include not only the explicitly recited limits of about 1nm and about 200nm, but also to include individual sizes such as 2nm, 3nm, 4nm, and sub-ranges such as 10nm to 50nm, 20nm to 100nm, and so forth.

Transport container

Referring now to fig. 38A-38B, there is shown an exploded perspective view of one non-limiting example of a transport container 3200 provided according to one embodiment described herein. It should be understood that the transport container 3200 may be configured with one or more features of any other transport container described elsewhere herein. By way of non-limiting example, the transport container 3200 may facilitate the transport of one or more sample vessels therein. In some embodiments, the transport vessel 3200 provides a thermally controlled interior region to minimize undesirable thermal decomposition of the sample during transport of the sample to another location (such as, but not limited to, an analytical facility). It should be understood that the shipping container may be placed within one or more other vessels during shipping.

In one embodiment, the sample vessel may be provided from a sample collection device for collecting a bodily fluid sample. By way of non-limiting example, the sample vessel may contain the sample in liquid form therein. In most embodiments, liquid form also includes embodiments that are suspensions.

By way of non-limiting example, the transport container 3200 may have any size. In some cases, transport container 3200 may have less than or equal to about 1m³、0.5m³、0.1m³、0.05m³、0.01m³、1000cm³、500cm³、300cm³、200cm³、150cm³、100cm³、70cm³、50cm³、30cm³、20cm³、15cm³、10cm³、7cm³、5cm³、3cm³、2cm³、1.5cm³、1cm³、700mm³、500mm³、300mm³、100mm³、50mm³、30mm³、10mm³、5mm³Or 1mm³Total volume of (c). The transport container may have a footprint and/or maximum cross-sectional area of less than or equal to about 1m²、0.5m²、0.1m²、0.05m²、100cm²、70cm²、50cm²、30cm²、20cm²、15cm²、10cm²、7cm²、5cm²、3cm²、2cm²、1.5cm²、1cm²、70mm²、50mm²、30mm²、10mm²、5mm²Or 1mm². In some cases, the shipping container can have a dimension (e.g., height, width, length, diagonal, or perimeter) of less than or equal to about 1m, 75cm, 50cm, 30cm, 25cm, 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.7cm, 0.5cm, 0.3cm, or 1 mm. In some cases, the largest dimension of the shipping container may be no greater than about 1m, 75cm, 50cm, 30cm, 25cm, 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.7cm, 0.5cm, 0.3cm, or 1 mm.

Alternatively, the shipping container may be lightweight. In some embodiments, the weight of the shipping container, with or without a sample vessel therein, can be less than or equal to about 10kg, 5kg, 4kg, 3kg, 2kg, 1.5kg, 1kg, 0.7kg, 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 1 mg.

As seen in fig. 38A and 38B, one embodiment of a shipping container may have a top cover 3210, a housing 3220 for a thermal regulating device, one or more insert trays 3230a, 3230B for the shipping container, and a bottom plate 3240.

In one embodiment, top cover 3210 has a substantially flat shape, although other shapes are not excluded. The top cover 3210 may cover a thermal conditioning device, such as, but not limited to, a heater or cooler contained in the shipping container. The top cover may or may not have the same footprint as the housing 3220 for the thermal regulating device. A cooler, heater, or other thermal regulating device 3220 may be provided within the transport container 3200. Alternatively, the device 3220 may be an active unit or a passive unit. The thermal regulating device may maintain the sample vessels within the transport container 3200 at a desired temperature or below a predetermined threshold temperature. Alternatively, the thermal conditioning device may be any temperature control unit known in the art. Alternatively, the thermal conditioning device may be capable of heating and/or cooling. Alternatively, the thermal conditioning device may be a thermoelectric cooler. Alternatively, the thermal conditioning device may be enclosed between the top cover and the housing for the cooler.

Optionally, the top cover and the housing may or may not form a hermetic seal. The top cover and/or the housing may be formed of a material having a desired thermal conductivity. For example, housing 3220 may have a selectable thermal conductivity. In one embodiment, the enclosure may include embedded Phase Change Material (PCM) within the case material so that the temperature is substantially uniform throughout. PCM possesses a very good temperature profile. It is desirable not to cause overcooling of the sample, such as associated with ice, which may create a negative drop as low as-5 ℃. The PCM may be configured to control the temperature range above freezing. By way of non-limiting example, the thermal conductivity may be in a range of between about 100-250W/m/K (watts/meter/kelvin). Optionally, each sample vessel will be in contact with the PCM. Some embodiments may have one PCM for each layer. The PCM material may be flow molded into the shipping container material. Optionally, there may be a chamber of PCM material. Alternatively, the gaps in the tray may be filled with PCM. PCM may provide a passive thermal control technique.

Alternatively, the PCM may be incorporated into the injection molding material. In such embodiments, the entire vessel may be the cooling medium. This may also prevent PCM from leaking from the chamber in the transport container. The shipping container size can also be reduced when the PCM is directly integrated into the shipping container material. The energy density is greater due to the increased storage capacity per unit mass. Mixing plastic with PCM material can be configured to be both strong and cool. By way of non-limiting example, 30% of the material may be PCM while the remainder is plastic that provides rigidity. By way of non-limiting example, between 20% and 40% of the material may be PCM, with the remainder being another material, such as, but not limited to, plastic that provides mechanical rigidity. Some embodiments may use a blow molded exterior filled with PCM or other material. The interior may be formed with different techniques because it may not be critical that the interior be attractive in appearance. Alternatively, cast molding or other lower temperature molding processes may also be used in place of or in combination with injection molding of the PCM-integrated shipping container material. The embedded PCM may also be in a tray. Some embodiments may be trays with much greater thermal conductivity to achieve a uniform, consistent cooling profile. Optionally, the PCM material is contained in a chamber within the chassis of the transport container, wherein the walls of the chamber may be thinner than the wall thickness of other areas of the transport box chassis.

In one embodiment, the transport container 3200 may also configure each of the trays 3230a and 3230b such that any information storage units on the sample vessels can be easily read without having to remove the sample vessels from the trays 3230a and 3230 b. In one example, the holder has an opening in the bottom that allows the information storage unit on the bottom to be visible while the sample vessels are still in trays 3230a and 3230 b.

Fig. 39 shows multiple views of a transport vessel 3200. Some of the figures show that the sample vessel holders in tray 3230a or 3230b may have an open bottom so that any information storage unit, such as, but not limited to, a bar code or other information storage unit, may be read from below or other orientations that do not require removal of sample vessels from transport container 3200. Optionally, only certain portions of the transport container 3200 (such as, but not limited to, layers, pallets, etc.) are removed to obtain the desired information. Alternatively, a bar code or other information storage unit may be accessed through one or more openings in the tray. This allows for barcode scanning of very small shipping containers. Alternatively, the rows of sample vessels may be scanned individually, or the entire tray may be scanned all at once. Optionally, all sample vessel holders may be visible to the user. Optionally, the computer vision system may also scan to see if steps such as centrifugation are complete. This may be at either end of the transport process. The computer vision system may visualize the sample vessel and determine whether the sample therein is in a form that confirms completion of the desired step. If it detects an error, the system may notify the user or system of the problem and/or re-execute the missing and/or erroneously performed step. Alternatively, the holder may have a closed bottom, and the information may be on the side or other surface of the transport container 3200.

In some embodiments, the shape of the holder may also be designed to follow the contours of the sample vessels 3134 located therein, thereby increasing the contact surface area and improving thermal control of the sample vessels. Alternatively, thermal control of the sample vessel may occur by heat transfer with the tray and/or the PCM, but not in direct contact with the PCM. Optionally, some sample vessels 3134 may also be in direct contact with the vessels and/or PCM. The openings of the sample vessels and/or holders may be in a straight line, in a honeycomb pattern, or in another pattern.

Referring now to fig. 40A and 40B, a fully assembled shipping container 3200 is shown. Fig. 40B shows a plurality of sample vessels 3134, such as those associated with a sample collection device. Sample vessels 3134 may all be from samples associated with one subject, in which case information about the set of samples may be provided using the information storage unit associated with tray 3230 a. Alternatively, the individual sample vessels may each still have the same information storage unit as that of tray 3230a, or they may each be unique. Some embodiments may insert sample vessels from multiple subjects into the same tray 3230 a. Alternatively, some embodiments may only partially fill each tray. Some embodiments may fill every opening in the tray, but not every sample vessel will have a sample therein (i.e., some sample vessels may be empty sample vessels that are inserted to provide uniform thermal distribution). These stackable trays 3230a can have a closure that uses elements such as, but not limited to, magnets, mechanical latches, or other coupling mechanisms to couple the trays together. In some embodiments, a magnet may be used to engage a tray containing sample vessels to support ease of opening during automation of loading and unloading. Optionally, the user may not remove the tray from the shipping container. Alternatively, the user may not remove the tray from the shipping container without using tools to release the tray. Some embodiments have a key mechanism (magnetic or other technology). In this way, the patient service center can put in the sample but not take it out. Optionally, some embodiments may have a shaped opening selected such that an individual cannot place the sample vessel and/or its holder in the wrong way, in order to prevent user error.

In one embodiment, loading and/or unloading may occur in a temperature regulated room or chamber to maintain the sample in a desired temperature range. In one embodiment, it is desirable to have a temperature range between about 1 ℃ to 10 ℃. Alternatively, it is desirable to have a temperature range between about 2 ℃ to 8 ℃. Alternatively, it is desirable to have a temperature range between about 4 ℃ to 5 ℃. Alternatively, the material of trays 230a and 230b may be used to provide a temperature controlled atmosphere for the sample vessels. Some embodiments use convection to control the heat distribution within the transport container 200.

Fig. 40B also shows that in this particular embodiment, there may be a groove 3232 for an O-ring or other seal that may provide a tight connection between the layers of the shipping container. The system may also include a closure mechanism 3234, such as, but not limited to, a magnetic closure, to hold the stackable insert tray in a desired position. It should be understood that some embodiments may have a through hole 3236 for routing one or more sensors in order to detect conditions experienced by the stackable insert tray during transport.

Fig. 40C illustrates various perspective views of the embodiment of fig. 40A and 40B when various components, such as stackable trays and lids, are coupled together to form a shipping container 3200. As seen in fig. 40C, the shipping container may include multiple layers of sample vessels or a tray with sample vessels. Alternatively, some embodiments may have only a single layer of sample vessels. Some embodiments may use active cooling or thermal control in one or more layers of the transport vessel 3200. By way of non-limiting example, one embodiment may have a thermoelectric cooler in the top layer. Alternatively, some embodiments may use a combination of active and passive thermal control. By way of 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 a desired temperature. An active thermal control unit may be included to maintain the PCM in a desired temperature range. Alternatively, some embodiments may use only thermal mass such as, but not limited to, PCM to maintain the temperature in a desired range.

Transport container with removable tray

Referring to fig. 41, yet another embodiment of a shipping container will now be described. Fig. 41 shows a transport container 3300 having a thermal control interior 3302, the thermal control interior 3302 housing a tray 3304 that can house a plurality of sample vessels 3306 in an array configuration, where each of the vessels 3306 house a majority of its sample in a free-flowing, non-wicking form, and where there is about 1ml or less of sample fluid in each vessel. Optionally, about 2ml or less of sample fluid is present in each vessel. Optionally, about 3ml or less of sample fluid is present in each vessel. In one non-limiting example, the vessels are arranged such that there are at least two vessels in each transport container having sample fluid from the same subject, wherein at least a first sample comprises a first anticoagulant and a second sample comprises a second anticoagulant in a matrix.

Although fig. 41 shows sample vessels held in an array configuration, other predetermined configurations are not excluded. Some embodiments may place the sample vessels in a hinged, swinging, or other holding mechanism in the tray that may allow movement in one or two degrees of freedom. Some embodiments may place sample vessels into such devices: the device has a first configuration during loading and then assumes a second configuration during transport to hold the sample vessels. Some embodiments may place sample vessels into such materials: the material has a first material property during loading and then assumes a second configuration (such as, but not limited to, hardening) during transport to hold the sample vessel.

In some embodiments, the sample vessels are in the holders 3310 and the tray 3304 defines openings and/or cavities sized to fit the holders 3310, but not the sample vessels. By way of non-limiting example, the holders 3310 may be used to physically hold the associated vessels 3306 together when they are in the tray 3304. Some embodiments have a retainer 3310 that directly contacts the tray 3304 in order to protect the ware from direct contact with the tray 3304. In one non-limiting example, the tray can hold at least 100 vessels, or alternatively, at least 50 holders each having two vessels.

Still referring to fig. 41, this embodiment of the shipping container 3300 may have some sort of retaining mechanism 3320, such as, but not limited to, clips, magnetic regions, etc., to retain the tray 3306. The retaining mechanism 3320 may be configured to retain the tray 3304 in a manner that may be released when desired. Optionally, the retaining mechanism 3320 may be configured to non-releasably retain the tray 3304. In the embodiment shown in fig. 41, the retaining mechanism 3320 is shown as a magnetic and/or metallic member in the tray 3304 that is attracted to a metallic and/or magnetic member in the transport container 3300. When the transport container 3300 reaches the processing facility, the tray 3304 may be configured to be removed from the transport container 3300. This can occur through the use of one or more techniques including, but not limited to, the use of strong magnets to engage magnetic and/or metallic components in the tray 3304. Some embodiments may use clamps, hooks, or other mechanical mechanisms to remove the tray 3304 from the transport container 3300. Some embodiments may use a combination of techniques to remove the tray 3304. It should also be understood that some embodiments may choose to remove the vessel 3306 and/or the holder 3310 while the tray 3304 remains in the transport container 3300. Some techniques may perform two or more of the foregoing techniques.

It should also be understood that the shipping container 3300 itself may be a cooling device, including a thermally controlled material such as, but not limited to, ice, PCM, and the like. Other embodiments may integrate the thermal control material directly into the material used to form the transport container 3300. As seen in fig. 41, some embodiments of the transport container 3300 may have a substantially empty space 3324 in which one or more thermal control materials are received or integrated.

Still referring to fig. 41, the transport container 3300 may also include an opening 3330 for attachment of a hinge or other connection means for connection of a cover or other layer to the transport container 3300. For ease of illustration, the cover and/or connections to the cover or other layers are not shown in fig. 41. Although some embodiments may use only a single layer, it should be understood that multi-layer embodiments are not excluded.

Referring to fig. 42, an exploded perspective view of yet another embodiment of a shipping container 3400 will now be described. The embodiment of fig. 42 is designed to hold trays 3402 in a shipping container interior 3404. An exploded perspective view shows a plurality of vessels 3406 in holders 3410 in a tray 3402. Tray 3402 may be configured such that some or all portions of retention mechanism 3420 are similar to retention mechanism 3320 in tray 3402. It should also be understood that the tray 3402 may have one or more cutouts, protrusions, or features to allow the tray 3402 to be inserted into the interior in a limited number of predetermined orientations. Some embodiments may be configured to support only one orientation of the tray in the vessel. Some embodiments may be configured to support only two possible orientations of the tray in the vessel.

Figure 42 illustrates that in one embodiment, the transport container 3400 may be formed from two separate pieces 3430 and 3432. Alternatively, some embodiments may be formed of three or more pieces. Alternatively, some embodiments may be a single piece. The parts 3430 and 3432 may have openings filled by plugs 3434 and 3436. The interior 3438 of the transport container 3400 may hold a thermally controlled material, such as, but not limited to, ice, phase change material, and the like. Other embodiments may integrate the thermal control material directly into the material used to form the transport vessel 3400.

In one instance, the interior 3433 of the part 3432 may be filled with a thermally controlled material such as, but not limited to, PCM. Alternatively, one embodiment may use an active thermal control material, such as, but not limited to, a thermoelectric cooler, to cool the interior.

Referring to fig. 43, yet another embodiment of a shipping container 3500 will now be described. Fig. 43 illustrates that the transport container 3500 can include a cover panel 3502 for covering features and/or sample vessels located therein. In some embodiments, the cover plate 3502 may include a thermally insulating material. Optionally, the cover plate 3502 may include a thermal control unit to assist in maintaining the interior of the transport container 3500 within a desired temperature range. Optionally, some embodiments may configure the cover plate 3502 as a thermally conductive material that may help maintain the interior of the transport container 3500 within a desired temperature range through heat transfer from an external thermal control source. By way of non-limiting example, the thermal control source may be a cooling source, a heating source, a thermoelectric heat exchanger, or other thermal control device. It should also be understood that similar thermal control sources, such as, but not limited to, PCM or active cooling devices, may also be included in the vacant space 3514 beneath the layer 3516.

It should be understood that the feature 3512 for holding the holders 3310, 3410 or other vessel-specific shaped holder may be located in a separate piece from the shipping container, or it may be integrally formed within the shipping container. Alternatively, feature 3512 may be part of a tray (such as trays 3302 and 3402 shown in fig. 41 and 42). Such trays may be fixed or removable from the shipping container 3500. A retaining mechanism 3520 may also be incorporated into the tray to allow it to remain in place during shipping.

Sample collection and transport

In embodiments, provided herein are systems and methods for the collection or transport of small volumes of bodily fluid samples.

In embodiments, a sample vessel containing a small volume of bodily fluid sample may be transported. The sample and sample vessel may have any of the respective characteristics described elsewhere herein. In embodiments, the sample vessel may contain less than or equal to 5ml, 3ml, 4ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10l or 5 l of body fluid sample. In embodiments, the sample vessel may have an internal volume of less than or equal to 5ml, 3ml, 4ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10l or 5 l. In embodiments, the sample vessel may have an internal volume of less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10l, or 5 l, and may comprise a body fluid sample filling at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99%, or 100% of the internal volume of the vessel. In embodiments, the sample vessel may be sealed, for example, with a cap, cover plate, or membrane. Any of the vessel internal dimensions or sample dimensions described herein may be applied to the internal dimensions of the sealed sample vessel, or the dimensions of the sample therein, respectively. In embodiments, the sealed sample vessel may have an internal volume of less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10l or 5 l and may comprise a body fluid sample filling at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99% or 100% of the internal volume of the vessel such that less than or equal to 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10l, 5 l, 4 l, 3 l, in the internal volume of the sealed vessel is present, 2 l or 1 l of air. Thus, for example, a sealed sample vessel may have an internal volume of less than or equal to 300 l, and it may contain a bodily fluid sample that fills at least 90% of the internal volume of the vessel, such that there is less than or equal to 30ul of air in the internal volume of the sealed vessel. In another example, the sealed sample vessel may have an internal volume of less than or equal to 500 l, and it may contain a bodily fluid sample that fills at least 80% of the internal volume of the vessel, such that there is less than or equal to 100ul of air in the internal volume of the sealed vessel. In another example, the sealed sample vessel may have an internal volume of less than or equal to 150l, and the others may contain a bodily fluid sample that fills at least 98% of the internal volume of the vessel, such that there is less than or equal to 3 l of air in the internal volume of the sealed vessel.

In embodiments, the sample vessel containing the sample may further comprise an anticoagulant. The anticoagulant can be dissolved in the sample or otherwise present in the vessel (e.g., dried on one or more interior surfaces of the vessel, or in solid form at the bottom of the vessel). A sample vessel containing a sample may have a "total anticoagulant content," where the total anticoagulant content is the total amount of anticoagulant present in the internal volume of the vessel and includes anticoagulant dissolved in the sample (if any), and anticoagulant not dissolved in the sample in the vessel (if any). In embodiments, a sample vessel containing a sample may contain no more than 1ml of sample and have a total anticoagulant content of no more than 3mg EDTA, may contain no more than 750 l of sample and have a total anticoagulant content of no more than 2.3mg EDTA, may contain no more than 500 l of sample and have a total anticoagulant content of no more than 1.5mg EDTA, may contain no more than 400 l of sample and have a total anticoagulant content of no more than 1.2mg EDTA, may contain no more than 300 l of sample and have a total anticoagulant content of no more than 0.9mg EDTA, may contain no more than 200 l of sample and have a total anticoagulant content of no more than 0.6mg EDTA, may contain no more than 150 l of sample and have a total anticoagulant content of no more than 0.45mg EDTA, may contain no more than 100 l of sample and have a total anticoagulant content of no more than 0.3mg EDTA, may contain no more than 75 l of sample and have a total anticoagulant content of no more than 0.23mg EDTA, may contain no more than 50 l of sample and have a total anticoagulant content of no more than 0.15mg EDTA, may contain no more than 40 l of sample and have a total anticoagulant content of no more than 0.12mg EDTA, may contain no more than 30 l of sample and have a total anticoagulant content of no more than 0.09mg EDTA, may contain no more than 20l of sample and have a total anticoagulant content of no more than 0.06mg EDTA, may contain no more than 10 l of sample and have a total anticoagulant content of no more than 0.03mg EDTA, or may contain no more than 5 l of sample and have a total anticoagulant content of no more than 0.015mg EDTA. In embodiments, a sample vessel containing a sample may contain no more than 1ml of sample and have a total anticoagulant content of no more than 2mg EDTA, may contain no more than 750 l of sample and have a total anticoagulant content of no more than 1.5mg EDTA, may contain no more than 500 l of sample and have a total anticoagulant content of no more than 1mg EDTA, may contain no more than 400 l of sample and have a total anticoagulant content of no more than 0.8mg EDTA, may contain no more than 300 l of sample and have a total anticoagulant content of no more than 0.6mg EDTA, may contain no more than 200 l of sample and have a total anticoagulant content of no more than 0.4mg EDTA, may contain no more than 150 l of sample and have a total anticoagulant content of no more than 0.3mg EDTA, may contain no more than 100 l of sample and have a total anticoagulant content of no more than 0.2mg EDTA, may contain no more than 75 l of sample and have a total anticoagulant content of no more than 0.15mg EDTA, may contain no more than 50 l of sample and have a total anticoagulant content of no more than 0.1mg EDTA, may contain no more than 40 l of sample and have a total anticoagulant content of no more than 0.08mg EDTA, may contain no more than 30 l of sample and have a total anticoagulant content of no more than 0.06mg EDTA, may contain no more than 20l of sample and have a total anticoagulant content of no more than 0.04mg EDTA, may contain no more than 10 l of sample and have a total anticoagulant content of no more than 0.02mg EDTA, or may contain no more than 5 l of sample and have a total anticoagulant content of no more than 0.01mg EDTA. In embodiments, a sample vessel containing a sample can contain no more than 1ml of sample and have a total anticoagulant content of no more than 30 United States Pharmacopeia (USP) units heparin, can contain no more than 750 l of sample and have a total anticoagulant content of no more than 23USP units heparin, can contain no more than 500 l of sample and have a total anticoagulant content of no more than 15USP units heparin, can contain no more than 400 l of sample and have a total anticoagulant content of no more than 12USP units heparin, can contain no more than 300 l of sample and have a total anticoagulant content of no more than 9USP units heparin, can contain no more than 200 l of sample and have a total anticoagulant content of no more than 6USP units heparin, can contain no more than 150 l of sample and have a total anticoagulant content of no more than 4.5USP units heparin, can contain no more than 100 l of sample and have a total anticoagulant content of no more than 3USP units heparin, no more than 75 l of sample may be contained and have a total anticoagulant content of no more than 2.3USP units heparin, no more than 50 l of sample may be contained and have a total anticoagulant content of no more than 1.5USP units heparin, no more than 40 l of sample may be contained and have a total anticoagulant content of no more than 1.2USP units heparin, no more than 30 l of sample may be contained and have a total anticoagulant content of no more than 0.9USP units heparin, no more than 20l of sample may be contained and have a total anticoagulant content of no more than 0.6USP units heparin, no more than 10 l of sample may be contained and have a total anticoagulant content of no more than 0.3USP units heparin, or no more than 5 l of sample may be contained and have a total anticoagulant content of no more than 0.15USP units heparin. In embodiments, a sample vessel containing a sample can contain no more than 1ml of sample and have a total anticoagulant content of no more than 15USP units heparin, can contain no more than 750 l of sample and have a total anticoagulant content of no more than 11USP units heparin, can contain no more than 500 l of sample and have a total anticoagulant content of no more than 7.5USP units heparin, can contain no more than 400 l of sample and have a total anticoagulant content of no more than 6USP units heparin, can contain no more than 300 l of sample and have a total anticoagulant content of no more than 4.5USP units heparin, can contain no more than 200 l of sample and have a total anticoagulant content of no more than 3USP units heparin, can contain no more than 150 l of sample and have a total anticoagulant content of no more than 2.3USP units heparin, can contain no more than 100 l of sample and have a total anticoagulant content of no more than 1.5USP units heparin, no more than 75 l of sample may be contained and have a total anticoagulant content of no more than 1.2USP units heparin, no more than 50 l of sample may be contained and have a total anticoagulant content of no more than 0.75USP units heparin, no more than 40 l of sample may be contained and have a total anticoagulant content of no more than 0.6USP units heparin, no more than 30 l of sample may be contained and have a total anticoagulant content of no more than 0.45USP units heparin, no more than 20l of sample may be contained and have a total anticoagulant content of no more than 0.3USP units heparin, no more than 10 l of sample may be contained and have a total anticoagulant content of no more than 0.15USP units heparin, or no more than 5 l of sample may be contained and have a total anticoagulant content of no more than 0.08USP units heparin.

In embodiments, two or more sample vessels comprising a sample from a single subject may be obtained or transported. When obtaining or transporting two or more sample vessels containing samples from a single subject, the two or more vessels may be stored or transported in vessels containing or not containing samples from other subjects. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels comprising samples from a single subject may be obtained or transported. In embodiments, no more than 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels comprising samples from a single subject may be obtained or shipped. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, or 9 sample vessels and no more than 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels comprising a sample from a single subject may be obtained or shipped. In embodiments involving two or more sample vessels containing samples from the same subject, the samples in each sample vessel may be obtained from the subject at the same or different times. In some embodiments involving two or more sample vessels containing samples from the same subject, the samples in each sample vessel may be from the same location or source site on the subject. For example, two sample vessels comprising whole blood from the same subject may be obtained, wherein both sample vessels comprise whole blood from the same fingerstick site. In other embodiments involving two or more sample vessels containing samples from the same subject, the samples in each sample vessel are from different locations/source sites on the subject. For example, two sample vessels comprising whole blood from the same subject may be obtained, wherein one sample vessel comprises whole blood from a first finger-prick site (e.g., on a first finger/toe) and a second sample vessel comprises whole blood from a second finger-prick site (e.g., on a second finger/toe). In embodiments involving two or more sample vessels containing samples from a single subject, the two or more sample vessels may contain different types of anticoagulants or other blood additives. For example, a first sample vessel may comprise whole blood with EDTA and a second sample vessel may comprise whole blood with heparin, wherein the samples are from the same subject. In another example, the first and second sample vessels may comprise whole blood with EDTA and the third sample vessel may comprise whole blood with heparin, wherein the samples are from the same subject. In another example, a first sample vessel may comprise whole blood with EDTA, a second sample vessel may comprise whole blood with heparin, and a third sample vessel may comprise whole blood with sodium citrate, wherein the samples are from the same subject. In embodiments involving two or more sample vessels containing samples from a single subject, the two or more sample vessels may contain different types of samples from the subject. For example, a first sample vessel may comprise whole blood and a second sample vessel may comprise plasma from the same subject. In another example, the first sample vessel may comprise whole blood and the second sample vessel may comprise urine from the same subject. In another example, the first and second sample vessels may comprise whole blood, while the third sample vessel may comprise saliva from the same subject.

In the systems and methods provided herein, a total volume of bodily fluid sample can be obtained from a subject. The total volume of bodily fluid sample may be transferred to a single sample vessel, or to two or more sample vessels. For example, a bodily fluid sample having a total volume of 500 microliters can be obtained from a subject and transferred into a single sample vessel, wherein the single sample vessel has a maximum internal volume of 600 microliters. In another example, a bodily fluid sample having a total volume of 500 microliters may be obtained from a subject and transferred into two sample vessels, wherein each sample vessel has a maximum internal volume of 300 microliters. In another example, a bodily fluid sample having a total volume of 500 microliters may be obtained from a subject and transferred into two sample vessels, wherein one sample vessel has a maximum internal volume of 400 microliters and one sample vessel has a maximum internal volume of 100 microliters. In the systems and methods provided herein, a total volume of bodily fluid sample of less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150 l, 100 l, 75 l, 50 l, 40 l, 30 l, 20 l, 10 l, 5 l, or 1 l can be obtained from a subject. The total volume of bodily fluid sample from the subject can be divided among 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more sample vessels, as described elsewhere herein. When a total volume of bodily fluid sample from a subject is dispensed between two or more sample vessels, portions of the total volume of bodily fluid sample in some or all of the different sample vessels may comprise different anticoagulants or other additives. For example, a bodily fluid sample having a total volume of 500 microliters may be obtained from a subject and transferred into two sample vessels, wherein one sample vessel contains a 250 microliter bodily fluid sample mixed with EDTA and one sample vessel contains a 250 microliter bodily fluid sample mixed with heparin. Generally, as used herein, total volume of a bodily fluid sample means a single type of bodily fluid sample-e.g., whole blood or urine or saliva, etc.

In embodiments, the sample vessel containing the whole blood may be centrifuged prior to its storage or transport, such that the whole blood is separated into plasma and pelleted cells prior to transport of the sample vessel. In other embodiments, the sample vessel containing the whole blood is not centrifuged prior to its storage or transport.

In some embodiments of the systems and methods provided herein, the bodily fluid sample can be dried after its collection and before its transport. In embodiments, the dried sample may be later reconstituted into a liquid form, such as upon analysis or processing of the sample.

In embodiments of the systems and methods provided herein, a sample vessel may be transported from a first location to a second location. The first location may be a location at which a sample is collected from a subject, and the second location may be a location at which one or more steps are performed in order to process or analyze the sample. The sample and sample vessel may have any of the respective characteristics described elsewhere herein. For example, the sample may be in a liquid, non-matrix, non-wicking form. The sample vessels may be transported in transport containers as described herein or in other structures. For example, in some alternative embodiments, the sample vessels may be shipped in bags, pouches, envelopes, boxes, capsules, or other structures. In embodiments, the first location and the second location may be within the same room, building, campus or building complex. In embodiments, the first location and the second location may be separated by 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. In embodiments, the first location and the second location may be separated by no more than 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 1000 kilometers. In embodiments, the first location and the second location may be separated by 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 no more than 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 1000 kilometers. In embodiments where the first location is a location at which a sample is obtained from a subject, the sample vessel may be transported from the first location to the second location within 48 hours, 36 hours, 24 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 of collecting a sample from the subject.

As used herein, a "sample receiving site" is a place where a transported sample can be received, and where one or more steps can be performed on the sample. For example, a sample arriving at a sample receiving site may be processed, analyzed, or disposed of at the sample receiving site, e.g., as part of a detection or assay of the sample. The sample may be transported, for example, in any vessel or device described herein. In embodiments, a sample receiving site may comprise one or more sample processing devices that may be used to process or analyze a sample. The sample processing device can be, for example, as described in U.S. patent application serial No. 13/244,947, filed on 26/9/2011, or as described in any other document incorporated by reference elsewhere herein. The sample may pass through any number of locations during transport of the sample from the sample collection site to the sample receiving site. In embodiments, the first location may be a sample collection site and the second location may be a sample receiving site.

Referring to FIG. 44, one embodiment of bodily fluid sample collection and transport will now be described. Fig. 44 shows a body fluid sample B located on the skin surface S of a subject. In the non-limiting example of FIG. 44, bodily fluid sample B can be collected by one of a variety of devices. By way of non-limiting example, the collection device 3530 can be, but is not limited to, those described in U.S. patent application serial No. 61/697,797 filed on 9/6/2012, which is hereby incorporated by reference in its entirety for all purposes. In this embodiment, bodily fluid sample B is collected by one or more capillary channels and then directed into sample vessel 3540. By way of non-limiting example, at least one of the sample vessels 3540 may have an interior that is initially under a partial vacuum for drawing the bodily fluid sample into the sample vessel 3540. Some embodiments can simultaneously draw a sample from a sample collection device into a sample vessel 3540 from the same or different collection channels in the sample collection device. Alternatively, some embodiments may draw the sample into the sample vessel simultaneously.

In this embodiment, after a bodily fluid sample is within sample vessel 3540, which is located in its holder 3542 (or, alternatively, removed from its holder 3542), is loaded into transport container 3500. In this embodiment, there may be one or more slots sized for sample vessel holders 3542, or slots for sample vessels in transport container 3500. By way of non-limiting example, the wells may receive sample vessels in an array configuration and be oriented in a vertical or some other predetermined orientation. It should be understood that some embodiments of sample vessels 3540 are configured such that they contain different amounts of sample in each vessel. By way of non-limiting example, this may be controlled based on the amount of vacuum force in each sample vessel, the amount of sample collected in one or more sample collection channels of the collection device, and/or other factors. Optionally, different pretreatments may also be present in the sample vessel, such as, but not limited to, different anticoagulants, and the like.

As seen in fig. 44, sample vessel 3540 is collecting a sample at a first location (such as, but not limited to, a sample collection site). By way of non-limiting example, the bodily fluid sample is then transported in transport container 3500 to a second location, such as, but not limited to, a receiving location, such as, but not limited to, an analysis location. The method of transportation may be by courier, postal express, or other transportation techniques. In many embodiments, shipping may be accomplished by having a further container in which the shipping container is housed. In one embodiment, the sample collection site may 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.

Although the present embodiment of fig. 44 shows collection of a bodily fluid sample from the surface of a subject, other alternative embodiments may use collection techniques for collecting samples from other areas of a subject, such as by venipuncture, to fill one or more sample vessels 3540. Such other collection techniques are not excluded for use as an alternative to or in conjunction with surface collection. The surface collection may be on an external surface of the subject. Alternatively, some embodiments may be collected from surfaces accessible within the body of the subject. The presence of body fluid sample B on these surfaces may occur naturally or may occur through wound creation or other techniques that make the body fluid surface accessible.

Referring now to fig. 45, described herein is yet another embodiment in which a sample of bodily fluid may be collected from within a subject as opposed to collecting a sample that is pooled on the surface of the subject. This embodiment of fig. 45 shows a collection device 3550 having a hypodermic needle 3552, the hypodermic needle 3552 being configured for collecting a bodily fluid sample, such as but not limited to venous blood. In one embodiment, a bodily fluid sample can fill chamber 3554 in device 3550, at which time one or more sample vessels 3540 can be engaged to draw the sample into the respective one or more vessels. Alternatively, some embodiments may not have chamber 3554, but rather have very little empty space other than one or more channels, one or more passageways, or one or more tubes for directing sample from needle 3552 to one or more sample vessels 3540. For a bodily fluid sample such as blood, the pressure from within the blood vessel is such that the blood sample can fill chamber 554 without much, if any, assistance from the collection device. Such embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape as the channels in the collection device are filled with sample.

At least some or all embodiments can have a fill indicator, such as, but not limited to, a viewing window or opening, that shows when a sample is present within the collection device and thus indicates that it is acceptable to engage one or more sample vessels 3540. Optionally, embodiments without a fill indicator are not excluded. After the desired fill level is reached, one or more filled sample vessels 3540 may be disconnected from the sample collection device. Optionally, one or more additional sample vessels 3540 can be coupled to the sample collection apparatus 3550 (or 530) to collect additional amounts of bodily fluid sample.

Fig. 46 illustrates a further embodiment of a sample collection device 3570. This embodiment described herein has a tissue penetrating portion 3572 such as, but not limited to, a hypodermic needle having a gripping portion 3574. Grip portion 3574 may facilitate positioning of tissue penetrating portion 3572 to more accurately enter the patient to a desired depth and position. In this embodiment, one or more sample collection vessels 3540 are located in carrier 3576 that is not in direct physical contact with tissue penetrating portion 3572. A fluid connection pathway 3578, such as but not limited to a flexible tube, may be used to connect tissue penetrating portion 3572 with one or more sample collection vessels 3540. Some embodiments have one or more such sample vessels 3540: the sample vessel 3540 is configured to be slidable to be in fluid communication with the tissue penetrating portion 3572 only under the control of a user. At least some or all embodiments can have a fill indicator, such as, but not limited to, a viewing window or opening, that shows when a sample is present within the collection device and thus indicates that it is acceptable to engage one or more sample vessels 3540. Optionally, embodiments without a fill indicator are not excluded. Some embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample. In most embodiments, one or more filled sample vessels 3540 can be disconnected from the sample collection device after a desired fill level is reached. Optionally, one or more additional sample vessels 3540 can be coupled to the sample collection device 3570 to collect additional amounts of bodily fluid sample.

Sample processing

Referring now to fig. 47, there is shown a system view of a shipping container 3500 having its contents unloaded by unloading assembly 3600 after reaching a destination location. In one embodiment, after the cover plate 3502 is positioned in the open position, the sample vessels positioned therein can be removed from the vessels 3500. By way of non-limiting example, the removal may be performed by removing the entire tray of sample vessels, removing a plurality of holders of sample vessels from the tray, and/or by individually removing the sample vessels. Some embodiments may use a robotic control structure 3602 that may move vertically as indicated by arrow 3604 and/or horizontally along a traversing bridge stage 3608 as indicated by arrow 3606 to remove sample vessels from the transport container 3500. A programmable processor 3610 may be used to control the position of the structure 3602 for manipulating the sample vessels. In one embodiment, the structure 3602 includes a magnet for engaging a retention mechanism to remove a tray from the structure 3602. Other embodiments using robotic arms and/or other types of programmable manipulators are not precluded and may be configured for use herein.

In embodiments, a sample may be removed from a sample vessel containing a sample when the sample vessel reaches a location for processing or analysis of the sample. The sample vessel may be processed (e.g., shaken, spun, mixed, or centrifuged) prior to removing the sample from the sample vessel. The sample may be removed from the sample vessel by any suitable mechanism, such as pipetting (e.g., by a fluid handling system or pipette), pouring, or mechanical force (e.g., by reducing the size of the interior region of the sample vessel to express the sample from the vessel). In embodiments, when a sample is removed from a sample vessel, little or no sample remains in the vessel (e.g., as a mechanical/transfer loss). For example, less than or equal to 50 l, 40 l, 30 l, 20 l, 15 l, 10 l, 5 l, 4 l, 3 l, 2 l, 1 l, or 0 l of sample may remain in the sample vessel after the sample is removed from the vessel.

By way of non-limiting example, samples in the sample vessel may then be processed using a system such as that described in U.S. patent application serial No. 13/244,947 filed on 26/9/2011, which is hereby incorporated by reference in its entirety for all purposes. The analytical system may be configured in compliance with CLIA as described in U.S. patent application serial No. 13/244,946, filed 9/26/2011, which is incorporated herein by reference in its entirety for all purposes. In embodiments, a sample transported according to the systems and methods provided herein may be divided into two or more smaller portions upon reaching a location for processing or analysis, and various assays may be performed on the sample. For example, in embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 assays can be performed on a sample transported according to the systems and methods provided herein. The assays may include different types of assays (e.g., for assaying proteins, nucleic acids, or cells) and use one or more detection methods (e.g., cell counting, luminescence, or spectrophotometer-based methods). In embodiments, two or more sample vessels comprising samples from a single subject may be transported, wherein the two or more sample vessels comprise at least two different anticoagulants mixed with the samples (e.g., one sample vessel comprises an EDTA-sample and one sample vessel comprises a heparin-sample). Samples from EDTA-sample vessels can then be used for one or more assays that are heparin sensitive or EDTA insensitive. Similarly, samples from a heparin-sample vessel may then be used for one or more assays that are EDTA sensitive or heparin insensitive. In embodiments, a sample transported according to the systems and methods provided herein can be split into two or more portions upon arrival at a destination and analyzed on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more different sample analyzers.

Referring now to fig. 49-51, it should be understood that at least any two of the tests on the list (fig. 49-51) can be performed using a sample from a subject prepared or shipped according to a system or method provided herein. For example, at least two tests on the list can be performed using a bodily fluid sample from the subject, wherein the total volume of the bodily fluid sample used to perform the tests does not exceed 300 microliters and the total volume of the bodily fluid sample from the subject is transported in liquid form in a sample vessel having an internal volume of 400 microliters or less. In another example, at least two tests on the list can be performed using a bodily fluid sample from the subject, wherein a total volume of the bodily fluid sample for performing the tests does not exceed 300 microliters, and the bodily fluid sample from the total volume of the subject is transported in liquid form in first sample vessels and second sample vessels, each vessel having an internal volume of 200 microliters or less, the first sample vessels containing the bodily fluid sample mixed with the first anticoagulant and the second sample vessels containing the bodily fluid sample mixed with the second anticoagulant. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 50, or 60 tests on the list (fig. 49-51) can be performed using a bodily fluid sample from the subject having a total volume of no greater than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750 l, 500 l, 400 l, 300 l, 200 l, 150 l, 100 l, 75 l, 50l, 40 l, 30 l, 20 l, 10 l, 5 l, or 1 l. The total volume of bodily fluid sample may be stored in a single sample vessel or transported from the collection site to the analysis or processing location, or it may be distributed among 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25 or more sample vessels. When the total volume of bodily fluid sample from a single subject is divided into two or more sample vessels, the sample portions in some or each sample vessel may comprise different anticoagulants or other additives. In an example, a total volume of no more than 300 microliters of a bodily fluid sample from a subject can be used to perform two or more assays, wherein at least one portion of the no more than 300 microliters of the sample is mixed with a first anticoagulant, and a second portion of the no more than 300 microliters of the sample is mixed with a second anticoagulant that is different from the first anticoagulant. Optionally, each portion of the sample of no more than 300 microliters is in its own sample vessel. Alternatively, two or more assays may be performed in which no more than 300 microliters of sample are all transported in a single vessel and contain a single anticoagulant. Optionally, at least any three tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. Optionally, at least any five tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. Optionally, at least any seven tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. Optionally, at least any ten tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. Optionally, at least any fifteen tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. Optionally, at least any twenty tests on the list can be performed using a total volume of no more than 300 microliters of blood from the subject for all tests. For any of the above, in at least some embodiments, at least one portion has a first anticoagulant and a second portion has a second anticoagulant that is different from the first anticoagulant.

Referring now to FIG. 52, yet another embodiment of a device for bodily fluid sample collection is shown. Fig. 52 shows a bodily fluid sample B of the subject being collected by collection device 3710. As seen in fig. 52, the collection device 3710 can include a collection portion 3712, such as, but not limited to, a capillary tube or other collection structure. The collection portion 3712 draws fluid therein, eventually directing the fluid toward the lumen 3714 of the device 3710. After the desired amount has been collected by the collection portion 3712, the entire device 3710 may be oriented as shown in fig. 52 so that gravity may then draw the sample into the cavity 3714. After all of the sample B has been moved into the cavity 3714, the collection portion 3712 can be removed from the device 3710. In one embodiment, the cap and collection portion 3712 are removed and replaced with a closed cap 3718. In one non-limiting example, the cap 3718 may be a cap without any openings thereon. Optionally, some embodiments may have a septum or other closeable opening in the cap, where the collection portion 3712 may be removed without having to replace the cap with a new cap of a different configuration.

Modular sample collection device

Referring now to fig. 53A-53C, while embodiments herein generally describe the sample collection device as having an adapter portion 3750 for connecting the sample collection portion 3740 with the sample storage vessel 3760, it should be understood that embodiments without such a configuration are not excluded.

By way of non-limiting example in fig. 53A, the one or more adapter portions 3750 can be discrete elements that are not initially in direct fluid communication with either the collection portion 3740 or the sample storage vessel 3760. Here, the collection portion 3740 can be connected to the vessel 3760 by way of relative motion (sequentially or simultaneously) between the collection portion, the adapter portion 3750, or one or more of the vessels 3760 to create a fluid pathway from the collection channel through the one or more adapter channels into the vessel.

By way of non-limiting example in fig. 53B, some embodiments may lack a separate, stand-alone adapter portion 3750, as previously set forth herein. Here, the collection portion 3740 may be directly connected to the vessel 3760 by way of relative movement between one or both of these elements as indicated by arrow 3770. As seen in fig. 53B, there may be a fluid flow feature 3780 having relative motion between one or both of these elements as indicated by arrow 3782. In one non-limiting example, the fluid flow feature 3780 can be a cap that engages an end of the collection portion 3740 to facilitate fluid flow into the vessel 3760. Optionally, the fluid flow feature 3780 may be a cap having a front surface shaped to engage the collection portion 3740. Optionally, the fluid flow feature 3780 may be a plunger, rod, and/or other device to facilitate flow toward the sample storage vessel 3760. Optionally, the fluid flow feature 3780 is not fully engaged until the sample collection portion 3740 is ready to engage the vessel 3760. Optionally, some embodiments may be configured such that the flow from the collection portion 3740 to the sample storage vessel 3760 does not use the fluid flow feature 3780, but is instead based on a different motive force, such as, but not limited to, gravity, vacuum suction, or a blowing force provided at an appropriate end of the collection portion 3740.

By way of non-limiting example in fig. 53C, one or more embodiments may use the collection portion 3740 as a storage vessel. Once the desired fill level is reached, some embodiments may simply cover both ends with caps 3790 and 3792. As seen in the diagram in fig. 53C, the caps 3790 and 3792 can retain fluid therein even when the portion 3740 is in a vertical orientation.

Variations and substitutions may be made to the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention. For example, there may be two or more capillaries in the collection portion 3740. Alternatively, they may each be formed as a separate tube or channel. Alternatively, some embodiments may have a common initial portion but separate outlet ports, such as but not limited to a Y-shaped configuration. It should be understood that any of the embodiments herein may be modified to incorporate the features set forth in the description with respect to fig. 53A-53C.

Referring now to fig. 54, after the sample vessel 3800 reaches the desired processing destination, the sample in the vessel 3800 may be appropriately prepared. In one embodiment, vessel 3800 is similar to vessel 3710. As seen in fig. 54, the sample may be processed to aliquot an aliquot into a processing device, such as but not limited to an inlet on a cartridge 3802 and another inlet on another cartridge 3804. In one embodiment, both cartridges 3802 are microfluidic disks that process samples for blood chemistry tests such as, but not limited to: comprehensive Metabolic Panel (ALB, ALP, ALT, AST, BUN, Ca, Cl-, CRE, GLU, K +, Na +, TBIL, tCO2, TP); basal Metabolic Panel (Basic Metabolic Panel) (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO 2); lipid Panel (cholesterol) (CHOL, HDL, CHOL/HDL, LDL, TRIG, VLDL, nhvlc); lipid Panel Plus (tCHOL, HDL, CHOL/HDL ratio, LDL, TRIG, VLDL, GLU, ALT, AST, nHDLc); liver group upgrade (Liver Panel Plus) (ALB, ALP, ALT, AST, AMY, TBIL, TP, GGT); electrolyte (Electrolyte Panel) (Cl-, K +, Na +, tCO 2); general Chemistry (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, GGT, GLU, TBIL, TP, UA); general Chemistry 6(General Chemistry 6) (ALT, AST, CRE, eGFR, GLU, BUN, GGT); renal Function Panel (Renal Function Panel) (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2 PHOS); metlyte (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU); renal Function (Kidney Function) (BUN, CRE, eGFR); liver function group (liver function Panel) (ALB, ALP, ALT, AST, DBIL, TBIL, TP); basal Metabolic Panel (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2, Mg, LDH); MetLyte Plus CRP (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU, CRP); BioChemistry Panel Plus (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, CRP, GGT, GLU, TP, UA); MetLac (ALB, BUN, Ca, Cl-, CRE, GLU, K +, LAC, Mg, Na +, Phos, tCO 2). It should be understood that other fluid processing techniques that may be developed in the future may also be suitable for use in at least one embodiment herein. In some embodiments, tubing may be used to transport the fluid to a destination such as, but not limited to, a fluid receiving port on the cartridge to deliver the sample to one or more universal chemical microfluidic/centrifugal cartridges 3802 (and/or 3804). At least one or more other cartridges, such as but not limited to an open fluid mobile cartridge as described in the applications incorporated by reference herein, may also be used to improve the types of detection available. Although at least two destination cartridges are shown, it should be understood that embodiments having more than two cartridges are not excluded (as shown by the additional cartridges shown in phantom). Fluid transport may be by pipettor, by fluid tubing, microfluidics, or by other fluid handling techniques that may be developed in the future.

Referring now to fig. 55A, it should be understood that some embodiments may use a sample processing system having one or more pipettors to extract a sample from a vessel 3800 in a tube-less manner. Although one or more pipettes are described in this embodiment, it should be understood that other fluid handling techniques that may be developed in the future may also be suitable for use in at least one embodiment herein. Fig. 55A illustrates an automated system that can be used to aliquot samples. It should also be understood that in some embodiments, there may be sample dilution before, during, or after the aliquot in order to increase the liquid volume of the sample. This may be beneficial for various purposes. Fig. 55A also shows that in some embodiments, a sample can be delivered to one or more universal chemical microfluidic/centrifugation cartridges 3802 (and/or 3804). At least one or more other cartridges, such as but not limited to an open fluid mobile cartridge as described in the applications incorporated by reference herein, may also be used to improve the types of detection available. Although at least two destination cartridges are shown, it should be understood that embodiments having more than two cartridges are not excluded (as shown by the additional cartridges shown in phantom). Fluid transport may be by pipettor, by fluid tubing, microfluidics, or by other fluid handling techniques that may be developed in the future. Some embodiments may use the same technique to move the sample to a cartridge or one or more other destinations, or alternatively some embodiments may use a combination of one or more techniques to move the sample. By way of example and not limitation, detection may involve augmenting the types of assays that may be performed using the cartridge 3806 other than general chemical detection using other detection techniques, such as, but not limited to, ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemistry, and/or other detection techniques. Alternatively, it should be understood that more than one cartridge 3802 and/or individual unit cartridges 3806 may be used herein along with a system for aliquoting from the vessel 3800.

Referring now to fig. 55B, a further embodiment is shown in which a vessel 3800 is shown with a sample fluid therein. In one example, the sample fluid therein may be "pure" or undiluted. Optionally, some embodiments may be configured such that the sample may be pre-treated at the collection site and/or the receiving site to dilute the sample and/or provide some chemical material into the sample. As seen in fig. 55B, the fluid handling system may aliquot samples from vessel 3800 to one or more other vessels 3810, 3812, and/or 3814 using pipettor 3602. By way of non-limiting example, the vessels 3810, 3812, or 3814 may be the same vessel as the vessel 3800. Alternatively, they may be different types of vessels. Based on the barcode or other information about the sample, the processor is programmed to determine at least one desired sample dilution and at least one desired number of aliquots for the sample. In this non-limiting example, the aliquots are each transported to one sample processing unit 3820, 3822, and 3824. The processing units may all be of the same type of processing unit, each of which may be of a different type from the others, or some of the processing units may be the same and some of the processing units may be different. In at least one non-limiting example, the sample processing unit can be a single sample processor or a batch processor that can process multiple samples simultaneously.

Fig. 55C shows a further embodiment in which the sample is collected at the collection site and then transported to the second site while the sample remains in liquid form. Fig. 55C shows multiple vessels with samples that can be collected from a single wound on a subject. This allows the subject to provide multiple samples that can be processed by different types of chemicals in each vessel. Fig. 55C illustrates that a courier may ship a transport container that may contain a sample from only one subject or multiple samples from multiple subjects to a receiving site. Although a human courier is shown, it should be understood that robotic transport, drones, or other transport techniques, systems, or devices that may be developed in the future are not excluded (including, but not limited to, transport of one or more "virtual" versions of a sample). In this non-limiting example, the receiving site can load one or more vessels 1504 from the transport container into a cartridge having independently movable reagent units and/or assay units. The cartridge may then be loaded into one or more process modules 701-707. These units may be the same module. Optionally, at least one of the modules is different from the other modules. Similar to fig. 55B, some embodiments may include a processor 3830, which may coordinate dilution and/or aliquoting (based on vessel ID or other associated information) of a sample from a vessel 1504 prior to loading the vessel 1504 containing the sample and/or pre-diluted sample, or one or more other vessels, into a cartridge. In at least one embodiment herein, each module can receive at least one cartridge and at least one sample vessel. Alternatively, more than one sample vessel may be placed in each cartridge. Alternatively, the sample vessels may contain different types of samples, such that the cartridge may have more than one type of sample loaded therein. Optionally, some embodiments may have a module with at least one receiving area for a cartridge and at least one receiving area for a sample.

Alternatively, some embodiments may have only one location for receiving a cartridge, which in turn also contains at least one sample. In this way, the risk of the user having to load individual items into the module is reduced. Once loaded, at least one embodiment herein is configured such that once the sample is inserted into the module, there is no further user manipulation of the sample. This non-limiting example may be used to minimize errors associated with artifacts once the sample is being processed in the module.

It should also be understood that some embodiments may use centrifugal or other forces to process multiple samples simultaneously to reduce the samples to a sediment level within the sample vessel. In one non-limiting example, this may be accomplished by way of a tray centrifuge (such as, but not limited to, a 384 well plate centrifuge).

FIG. 55C shows a system 700 having a plurality of modules 701-706 and a cytometry station 707, according to an embodiment of the invention. The plurality of modules includes 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 cytometry station 707 is operably coupled to each of the plurality of modules 701-706 through a sample processing system 708. As described herein, the sample processing system 708 may include a pipette, such as a positive displacement, vented, or aspirated pipette.

As described above and in other embodiments of the invention, the cell counting station 707 includes a cell counter for performing cell counting on a sample. The cytometry station 707 can perform cell counting on a sample while one or more of the modules 701-706 perform other preparation and/or assay protocols on another sample. In some cases, the cytometry station 707 performs cell counting on the sample after the sample has undergone sample preparation within one or more of the modules 701-706.

The system 700 includes a support structure 709 having a plurality of stands (or mounting tables). The plurality of stations are used to interface modules 701 and 706 to support structure 709. As shown, the support structure 709 is a frame.

Each module is secured to a rack 709 by means of attachment members. In one embodiment, the attachment member is a hook secured to the module or the stand. In such a case, the hook is configured to slide into a receptacle of the module or station. In another embodiment, the attachment member includes a fastener, such as a screw fastener. In another embodiment, the attachment member is formed of a magnetic material. In such a case, the module and the stage may include magnetic materials of opposite polarity to provide an attractive force to secure the module to the stage. In another embodiment, the attachment member comprises one or more rails or tracks in the table. In such a case, the module includes one or more structures for mating with one or more rails or tracks to secure the module to the rack 709. Alternatively, the power may be provided by a rail.

Examples of structures that may allow the module to mate with the rack may include one or more pins. In some cases, the modules receive power directly from the rack. In some cases, the module may be a power source that internally powers the device, such as a lithium ion battery or a fuel cell powered battery. In an example, the module is configured to mate with the rack by way of rails, while the power of the module comes directly from the rails. In another example, the module mates with the rack by means of attachment members (rails, pins, hooks, fasteners), but provides power to the module wirelessly, such as inductively (i.e., inductively coupled). In some embodiments, the module that mates with the rack does not necessarily require a pin. For example, inductive electrical communication may be provided between the module and the rack or other support. In some cases, wireless communication may be used, such as by way of ZigBee communication or other communication protocols or protocols that may be developed in the future.

Each module is removable from the rack 709. In some cases, a module may be replaced with the same, similar, or different module. In one embodiment, the module is removed from the rack by sliding the module out of the rack 709. In another embodiment, the module is removed from the rack 709 by twisting or turning the module so that the attachment members of the module disengage from the rack 709. Removal of the module from the rack 709 may terminate any electrical connectivity between the module and the rack 709.

In one embodiment, the module is attached to the rack by sliding the module into the dock. In another embodiment, the module is attached to the rack by twisting or turning the module so that the attachment members of the module engage the rack 709. Attaching the module to the rack 709 may establish electrical connections between the module and the rack. The electrical connections may be used to provide power to or from the module to the rack or to the device, and/or to provide a communication bus between the module and one or more other modules or controllers of system 700.

Each station of the rack may or may not be occupied. As shown, all of the bays of rack 709 are occupied by modules. However, in some cases, one or more bays of rack 709 are unoccupied by a module. In an example, the first module 701 has been removed from the rack. In such a case, the system 700 may operate without the module being removed.

In some cases, the station may be configured to receive a subset of the types of modules that the system 700 is configured to use. For example, the station may be configured to receive a module capable of running an agglutination assay instead of a cell count assay. In such a case, the module may be "dedicated" to agglutination. Agglutination can be measured in a variety of ways. Measuring the time-dependent change in turbidity of a sample is one method. This can be done by illuminating 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 will increase as more light is scattered by the sample. Measuring the time-dependent change in transmittance is another example. In the latter case, this may be achieved by illuminating the sample in the vessel and measuring the light passing through the sample with an optical sensor (such as a photodiode or camera). Over time, the measured light may decrease or increase as the sample agglutinates (e.g., depending on whether the agglutinated material remains in suspension or precipitates out of suspension). In other cases, the station may be configured to receive all types of modules that the system 700 is configured to use, ranging from the inspection station to the supporting electrical system.

Each module may be configured to function (or execute) independently of the other modules. In an example, the first module 701 is configured to execute independently of the second module 702, the third module 703, the fourth module 704, the fifth module 705, and the sixth module 706. In other cases, a module is configured to execute with one or more other modules. In such a case, the module may support parallel processing of one or more samples. In an example, the second module 702 performs an assay on the same or a different sample while the first module 701 prepares the sample. This may support minimizing and eliminating downtime between modules.

The support structure (or rack) 709 may have a server type configuration. In some cases, the dimensions of the racks are standardized. In an example, the spacing between modules 701 and 706 is normalized to a multiple of at least about 0.5 inches, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches, or 8 inches, or 9 inches, or 10 inches, or 11 inches, or 12 inches.

The rack 709 may support the weight of one or more of the modules 701 and 706. Further, the rack 709 has a center of gravity selected such that the module 701 (top) is mounted on the rack 709 without creating a moment arm that may cause the rack 709 to rotate or tip over. In some cases, the center of gravity of the rack 709 is arranged between the vertical midpoint of the rack and the bottom of the rack, with the vertical center being 50% from the bottom of the rack 709 to the top of the rack. In one embodiment, the center of gravity of the rack 709 is disposed at least about 0.1%, or 1%, or 10%, or 20%, or 30%, or 40%, or 50%, or 60%, or 70%, or 80%, or 90%, or 100% of the rack height measured from the bottom of the rack 709 as measured along a longitudinal axis away from the bottom of the rack 709.

The rack may have a plurality of bays (or mounting stations) configured to receive one or more modules. In the example, the rack 709 has six mounting stations for allowing each of the modules 701 and 706 to be mounted to the rack. In some cases, the stations are located on the same side of the rack. In other cases, the stations are located on alternating sides of the rack.

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

In some embodiments, system 700 includes a controller (not shown) for facilitating processing of the sample via one or more of modules 701 and 706. In one embodiment, the controller facilitates parallel processing of the samples in modules 701-706. In an example, the controller directs the sample handling system 708 to provide samples in the first module 701 and the second module 702 in order to run different assays on the samples simultaneously. In another example, the controller directs the sample processing system 708 to provide the sample within one of the modules 701-706, and also to provide the sample (e.g., a portion of the limited volume of the sample) to the cytometry station 707, such that the cell count of the sample and one or more other sample preparation protocols and/or assays are performed in parallel. In this manner, the system minimizes, if not eliminates, downtime between modules 701-706 and the cytometry station 707.

Each individual module of the plurality of modules may include a sample processing system for providing and removing samples to and from the respective processing and assay modules of the individual module. Further, each module may include various sample processing and/or assay modules, in addition to other components for facilitating processing and/or assaying of a sample via the module. The sample processing system of each module may be separate from the sample processing system 708 of the system 700. That is, sample handling system 708 transfers samples to and from modules 701-706, while the sample handling system of each module transfers samples to and from the various sample processing and/or assay modules included within each module.

In the example of fig. 55C, the sixth module 706 includes a sample processing system 710, the sample processing system 710 including a suction pipette 711 and a positive displacement pipette 712. The sixth module 706 includes a centrifuge 713, a spectrophotometer 714, a nucleic acid assay (such as a Polymerase Chain Reaction (PCR) assay) station 715, and a PMT 716. An example of spectrophotometer 714 is shown in fig. 55C (see below). The sixth module 706 further comprises a cartridge 717, the cartridge 717 for holding a plurality of tips for facilitating sample transfer to and from each processing or assay module of the sixth module.

In one embodiment, the suction pipette 711 includes 1 or more, or 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7 or more, or 8 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 the example, the suction pipette 711 is an 8-tip pipette with eight tips. Suction pipette 711 may be as described in other embodiments of the present invention.

In some embodiments, positive displacement pipette 712 has a coefficient of variation of less than or equal to about 20%, 15%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.3%, or 0.1% or less. The coefficient of variation is determined in terms of σ/μ, where "σ" is the standard deviation and "μ" is the average over the entire sample measurement.

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 the example, the first, second, third, fourth, fifth, and sixth modules 701 and 706 include positive displacement pipettes and pipette pipettes as well as various assays, such as nucleic acid assays and spectrophotometers. In another example, at least one of modules 701-706 may have a different assay and/or sample preparation station than the other modules. In an example, the first module 701 includes an agglutination assay but does not include a nucleic acid amplification assay, while the second module 702 includes a nucleic acid assay but does not include an agglutination assay. The module may not include any assays.

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

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

In one embodiment, the modules are stacked vertically, i.e., one module on top of another module. In the example illustrated in fig. 55C, the racks 709 are oriented such that the modules 701 and 706 are disposed vertically with respect to each other. However, in other cases, the modules are disposed horizontally with respect to each other. In such a case, the racks 709 may be oriented such that the modules 701-706 may be seated horizontally alongside one another.

In yet another embodiment of system 730, the system is shown with a plurality of modules 701 through 704. This embodiment shows a horizontal configuration, where modules 701-704 are mounted to a support structure 732, on which support structure 732 transport device 734 may be moved along the X-axis, Y-axis, and/or optionally along the Z-axis to move elements such as, but not limited to, sample vessels, tips, tubes, etc. within and/or between modules. By way of non-limiting example, if modules 701-704 are oriented along a plane that is orthogonal, substantially orthogonal, or nearly orthogonal to the gravitational acceleration vector, they are oriented horizontally with respect to each other.

It should be understood that, as with the embodiment of fig. 55C, modules 701-704 may all be identical to one another. In another embodiment, at least some of the modules are different from each other. In an example, the first, second, third and/or fourth modules 701 and 704 may be replaced by one or more other modules that may occupy the location of the replaced module. Other modules may optionally provide different functionality, such as, but not limited to, replacing one of modules 701 and 704 with one or more of a cytometry module 707, a communications module, a storage module, a sample preparation module, a slide preparation module, a tissue preparation module, and the like. For example, one of modules 701-704 may be replaced with one or more modules providing different hardware configurations, such as, but not limited to, providing a thermally controlled storage chamber for incubation, storage between assays, and/or storage after assays. Optionally, modules replacing one or more of modules 701 and 704 may provide non-assay related functionality such as, but not limited to, additional telecommunications equipment, additional imaging or user interface equipment for system 730, or additional power sources such as, but not limited to, batteries, fuel cells, and the like. Optionally, modules replacing one or more of modules 701-704 may provide storage for additional disposables and/or reagents or fluids. It should be understood that while some embodiments show only four modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this horizontal mounting configuration. It should also be understood that the configuration may also operate where not every station or slot is occupied by a module, particularly in any scenario where one or more types of modules draw more power than others. In such a configuration, the power that would have been directed to the vacant sites may be used by modules that may draw more power than other modules.

It should be understood that, as with the embodiment of fig. 55C, modules 701-706 may all be identical to one another. In another embodiment, at least some of the modules are different from each other. In an example, the first, second, third and/or fourth modules 701 and 706 may be replaced by one or more other modules that may occupy the location of the replaced module. Other modules may optionally provide different functionality, such as, but not limited to, replacing one of modules 701-706 with one or more of a cytometry module 707, a communications module, a storage module, a sample preparation module, a slide preparation module, a tissue preparation module, and the like.

It should be understood that while some embodiments show only six modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this horizontal and vertical mounting arrangement. It should also be understood that the configuration may also operate where not every station or slot is occupied by a module, particularly in any scenario where one or more types of modules draw more power than others. In such a configuration, the power that would have been directed to the vacant sites may be used by modules that may draw more power than other modules.

Some embodiments may provide a system with a plurality of modules 701, 702, 703, 704, 706, and 707. Such embodiments may have additional modules that may contain one or more modules that provide different hardware configurations, such as, but not limited to, providing a thermal control storage chamber for incubation, storage between assays, or storage after assays. Optionally, a module replacing one or more of modules 701 and 704 may provide non-assay related functionality such as, but not limited to, additional telecommunications equipment, additional imaging or user interface equipment for the system, or additional power sources such as, but not limited to, batteries, fuel cells, and the like. Optionally, modules replacing one or more of modules 701-707 may provide storage for additional disposables and/or reagents or fluids.

It should be understood that although fig. 55C shows seven modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this mounting configuration. It should also be understood that the configuration may also operate where not every station or slot is occupied by a module, particularly in any scenario where one or more types of modules draw more power than others. In such a configuration, the power that would have been directed to the vacant sites may be used by modules that may draw more power than other modules.

In some implementations, the modules 701-706 communicate with each other and/or with controllers of the system 700 via a communication bus ("bus") that may include electronic circuitry and components for facilitating communication between the modules and/or controllers. The communication bus includes subsystems that transfer data between the modules and/or controllers of the system 700. The bus may place the components of system 700 into communication with a Central Processing Unit (CPU), memory (e.g., internal memory, system cache), and storage location (e.g., hard disk) of system 700.

The communication bus may comprise parallel wires with multiple connections, or any physical arrangement that provides a logical function as a parallel electrical bus. The communication bus may include parallel connections and bit-serial connections and may be wired in a multi-drop (i.e., electrically parallel) or daisy-chain topology or connected through a switching hub. In one embodiment, the communication bus may be a first generation bus, a second generation bus, or a third generation bus. The communication bus allows communication between each module and other modules and/or controllers. In some cases, the communication bus supports communication between multiple systems, such as between multiple systems similar or identical to system 700.

The system 700 may include one or more serial buses, parallel buses, or self-healing buses. The bus may include a master scheduler that controls data traffic, such as traffic to and from modules (e.g., modules 701 and 706), controllers, and/or other systems. The bus may include an external bus that connects external devices and systems to a main system board (e.g., a motherboard); and an internal bus connecting internal components of the system to the system board. The internal bus connects the internal components to one or more Central Processing Units (CPUs) and internal memory.

In some embodiments, the communication bus may be a wireless bus. The communication bus may be Firewire (IEEE 1394), USB (1.0, 2.0, 3.0 or other), Thunderbolt or other protocol (existing or future developed).

In some embodiments, system 700 includes one or more buses selected from the group consisting of: media bus, computer AutoMeasure and control (CAMAC) bus, Industry Standard Architecture (ISA) bus, USB bus, Firewire, Thunderbolt, Extended ISA (EISA) bus, low-pin-count bus, MBus, microchannel bus, multibus, NuBus or IEEE 1196, OPTi local bus, Peripheral Component Interconnect (PCI) bus, parallel Advanced Technology Attachment (ATA) bus, Q-bus, S-100 bus (or IEEE 696), SBus (or IEEE 1496), SS-50 bus, STE bus, STD bus (for STD-80[ 8-bit ] and STD32[ 16-/32-bit ]), monobus, VESA local bus, VME bus, PC/104Plus bus, PC/104Express bus, PCI-104 bus, PCIe-104 bus, 1-wire bus, HyperTransport bus, inter-Integrated Circuit (I2C) bus, PCI-bus, PCI Express (or PCIe) bus, Serial ATA (SATA) bus, serial peripheral interface bus, UNI/O bus, SMBus, 2-wire or 3-wire interface, self-healing flexible interface bus, and variations and/or combinations thereof.

In some cases, system 700 includes a Serial Peripheral Interface (SPI), which is the interface between one or more microprocessors and peripheral or I/O components (e.g., modules 701 and 706) of system 700. The SPI may be used to attach 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7 or more, or 8 or more, or 9 or more, or 10 or more, or 50 or more, or 100 or more SPI-compatible I/O components to a microprocessor or microprocessors. In other cases, system 700 includes RS-485 or other standards.

In one embodiment, an SPI is provided having an SPI bridge with a parallel and/or series topology. Such bridging allows selection of one of many SPI components of an SPI I/O bus without proliferation of chip selection. This is accomplished by applying appropriate control signals as described below to allow daisy chaining of devices or chip selection for devices on the SPI bus. However, it does not maintain a parallel data path, so there is no daisy-chain data to be transferred between the SPI component and the microprocessor.

In some embodiments, an SPI bridging component is provided between a microprocessor and multiple SPI I/O components connected in a parallel and/or serial (or series) topology. The SPI bridge component supports parallel SPI using MISO and MOSI lines, as well as serial (daisy-chain) local chip select connections (CSL /) to other slave devices. In one embodiment, the SPI bridge component provided herein addresses any issues associated with multi-chip selection for multiple slave devices. In another embodiment, the SPI bridge component provided herein supports 4, 8, 16, 32, 64 or more individual chip selections for 4 SPI-enabled devices (CS 1/-CS 4 /). In another embodiment, the SPI bridge component provided herein supports 4-fold concatenation with an external address line arrangement (ADR 0-ADR 1). In some cases, the SPI bridge component provided herein provides the ability to control up to 8, 16, 32, 64, or more general output bits for control or data. The SPI bridge component provided herein, in some cases, supports control of up to 8, 16, 32, 64 or more generic output bits for control or data and can be used for device identification of the master station and/or diagnostic communication to the master station.

One embodiment may use an SPI bridging scheme with a master bridge and a parallel-to-serial SPI slave bridge according to embodiments of the present invention. The SPI bus is enhanced by adding local chip select (CSL /), module select (MOD _ SEL), and select data input (DIN _ SEL) to the SPI bridge, allowing for the addition of various system features including essential and non-essential system features, such as cascading of multiple slave devices, virtual daisy-chaining of device chip selects to keep module-to-module signal counts at an acceptable level, support for module identification and diagnostics, and communication with non-SPI components on the module while maintaining compatibility with embedded SPI-compatible slave components. Fig. 41B shows an example of SPI bridging 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 station (also referred to herein as an "SPI master" or "master bridge") in a parallel-serial configuration. Each slave bridge MOSI pin is connected to the master bridge MOSI pin, and the slave bridge MOSI pins are connected to each other. Similarly, the MISO pin of each slave bridge is connected to the MISO pin of the master bridge, and the MISO pins of the slave bridges are connected to each other.

Each slave bridge may be a module (e.g., one of the modules 701 and 706 of fig. 55C) or a component in a module. In an example, the first slave bridge is the first module 701, the second slave bridge is the second module 702, and so on. In another example, the first slave bridge is a component of the module.

At least one non-limiting example may use a module assembly diagram having interconnected module pins and various components of a master bridge and a slave bridge according to embodiments of the present invention. According to an embodiment of the present invention, the slave bridge may be connected to the master bridge. The MISO pin of each slave bridge is in electrical communication with the MOSI pin of the master bridge. The MOSI pin of each slave bridge is in electrical communication with the MISO pin of the master bridge. The DIN _ SEL pin of the first slave bridge (left) is in electrical communication with the MOSI pin of the first slave bridge. The DOUT _ SEL pin of the first slave bridge is in electrical communication with the DIN _ SEL pin of the second slave bridge (right). The additional slave bridges may be connected as second slaves by bringing the DIN _ SEL pin of each additional slave bridge into electrical communication with the DOUT _ SEL pin of the preceding slave bridge. In such a case, the slave bridges are connected in a parallel-series configuration.

In some embodiments, when the module select line (MOD _ SEL) is asserted, the CLK pulse directed to the connected SPI bridge captures the state shifted to the DIN _ SEL bit in the bridge. The number of DIN _ SEL bits corresponds to the number of modules connected together on the parallel-to-serial SPI link. In one example, if two modules are connected in a parallel-series configuration (e.g., RS486), then the number of DIN _ SELs is equal to 2.

In one embodiment, the SPI that latches a "1" during the module selection sequence bridges into a "selected module" that is configured to receive an 8-bit control word during a subsequent component selection sequence. Each SPI bridge can access up to 4 cascaded SPI slaves. Further, each SPI bridge may have an 8-bit GP receive port and an 8-bit GP transmit port. The "component select" sequence writes an 8-bit word into the "selected module" SPI bridge control register to support subsequent transactions with a particular SPI device or to read and write data via the SPI bridge GPIO port.

In one embodiment, component selection is performed by asserting a local chip select line (CSL /) and then clocking the first byte of the MOSI transferred data word into a control register. In some cases, the format of the control register is CS4CS3CS2CS1AD1AD0R/W N. In another embodiment, the second byte is transmit or receive data. When CSL/is deasserted, the loop is complete.

In an SPI transaction, following a component selection sequence, a subsequent SPI slave data transaction is started. The SPI CS/(which may be referred to as SS /) is routed to one of 4 possible bridging devices according to the true state of CS4, CS3, CS2, or CS 1. The jumper bits AD0, AD1 are compared to the control registers AD0, AD1, allowing up to 4 SPI bridges on the module.

One embodiment shows a device according to an embodiment of the invention having a plurality of modules mounted on an SPI link of a communication bus of the device. The figure shows 3 modules, module 1, module 2 and module 3. Each module includes one or more SPI bridges for bringing the various components of the module into electrical connection with an SPI link, including a master controller (including one or more CPUs) in electrical communication with the SPI link. Module 1 includes a plurality of SPI slaves in electrical communication 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, modules 701-706 are configured to communicate with each other and/or with one or more controllers of system 700 via a wireless communication bus (or interface). In one example, modules 701 and 706 communicate with each other via a wireless communication interface. In another example, one or more of the modules 701-706 communicate with a controller of the system 700 via a wireless communication bus. In some cases, communication between the modules 701 and 706 and/or one or more controllers of the system is only over a wireless communication bus. This may advantageously eliminate the need for a wired interface in the station for receiving modules 701-706. In other cases, system 700 includes a wired interface that works in conjunction with a wireless interface of system 700.

Although system 700 is shown with a single rack, a system (such as system 700) may have multiple racks. In some embodiments, a system has at most 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 10000 racks. In one embodiment, the system has a plurality of racks disposed in a side-by-side configuration.

In some embodiments, a user provides a sample to a system having one or more modules, such as 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 comprises one or more lancets, needles, microneedles, phlebotomists, scalpels, cups, swabs, detergents, buckets, baskets, kits, permeable matrices, or any other sample collection mechanism or method described elsewhere herein. Next, the system directs the sample from the sample collection module to one or more processing modules (e.g., modules 701-706) for sample preparation, assay, and/or detection. In one embodiment, the sample is directed from the collection module to the one or more processing modules by means of a sample processing system, such as a pipette. Next, the sample is processed in the one or more modules. In some cases, a sample is assayed in one or more modules and then subsequently subjected to one or more detection routines.

In some implementations, after processing in one or more modules, the system transmits the results to a user or system (e.g., a server) in communication with the system. Other systems or users may then take the results to assist in treating or diagnosing the subject.

In one embodiment, the system is configured for bidirectional communication with other systems, such as similar or identical systems (e.g., racks, such as the rack described in the context of fig. 55C) or other computer systems, including servers.

The apparatus and methods provided herein may advantageously reduce the energy or carbon footprint of a point of service system by supporting parallel processing. In some cases, a system, such as system 700 of fig. 55C, has a footprint that is at most 10%, or 15%, or 20%, or 25%, or 30%, or 35%, or 40%, or 45%, or 50%, or 55%, or 60%, or 65%, or 70%, or 75%, or 80%, or 85%, or 90%, or 95%, or 99% of other point of service systems.

In some embodiments, methods for detecting an analyte are provided. In one embodiment, the processing routine includes detecting the presence or absence of an analyte. The processing routine is facilitated by the systems and devices provided herein. In some cases, the analyte is associated with a biological process, a physiological process, an environmental condition, a sample condition, a disorder, or a stage of a disorder, such as one or more of an autoimmune disease, obesity, hypertension, diabetes, a neuronal and/or muscle degenerative disease, a cardiac disease, and an endocrine disease.

In some cases, the device processes one sample at a time. However, the systems provided herein are configured for multiplexed sample processing. In one embodiment, the device processes multiple samples at once or at overlapping times. In one example, a user provides a sample to a device having a plurality of modules, such as the system 700 of fig. 55C. The device then processes the sample by means of one or more modules of the device. In another example, a user provides a plurality of samples to a device having a plurality of modules. The device then processes the sample simultaneously with the plurality of modules by processing a first sample in a first module while processing a second sample in a second module.

The system can process the same type of sample or different types of samples. In one embodiment, the system processes one or more portions of the same sample simultaneously. This may be useful if various assay and/or detection protocols for the same sample are desired. In another embodiment, the system processes different types of samples simultaneously. In one example, the system processes blood and urine samples simultaneously in different modules of the system, or in a single module having processing stations for processing blood and urine samples.

In some embodiments, a method for processing a sample with a point of service system (such as system 700 of fig. 55C) comprises: the detection criteria or parameters are admitted and a detection order or scheduling is determined based on the criteria. The detection criteria are received from a user, system or server in communication with the service point system. The criteria may be selected based on desired or predetermined effects, such as: minimal time, cost, component usage, steps, and/or energy. The point-of-service system processes the samples in a detection order or schedule. In some cases, a feedback loop (coupled with the sensor) enables the point of service system to monitor the progress of the sample processing and maintain or change the detection sequence or schedule. In one example, if the system detects that the process takes longer than a predetermined amount of time set forth in the schedule, the system speeds up the process or adjusts any parallel processes, such as sample processing in another module of the system. The feedback loop allows real-time or pseudo real-time (e.g., buffered) monitoring. In some cases, a feedback loop may provide for allowing reflection detection, which may result in initiation of subsequent detection, assays, preparation steps, and/or other processes after another detection and/or assay or sensing of one or more parameters is initiated or completed. Such subsequent detection, assay, preparation steps and/or other processes may be initiated automatically without any human intervention. Optionally, the reflection detection is performed in response to the determination. That is, by way of non-limiting example, if reflectance detection is predetermined, the cartridge is pre-loaded with reagents for assay a and assay B. Assay a is a preliminary assay and assay B is a reflectance assay. If the result of assay A meets the predetermined criteria for initiating the detection of a reflection, then assay B is run in the apparatus with the same sample. The plant solution is planned to take into account the possibility of running reflection detection. Some or all of the protocol steps of assay B may be performed before the results of assay a are complete. For example, sample preparation can be accomplished prior to lifting the device. It is also possible to run reflectance measurements with a second sample from the patient. In some embodiments, the devices and systems provided herein can comprise components such that a plurality of different assays and assay types can be reflectively detected with the same device. In some embodiments, multiple assays of clinical significance can be performed in a single device provided herein as part of a reflectance detection scheme, where two or more separate devices are required to perform the same assay with known systems and methods. Thus, the systems and devices provided herein may, for example, allow for reflectance detection that is faster and requires less sample than known systems and methods. Furthermore, in some embodiments, it is not necessary to know in advance which kind of reflection detection will be performed for reflection detection with the apparatus provided herein.

In some embodiments, the service point system may adhere to a predetermined detection order or schedule based on initial parameters and/or desired effects. In other embodiments, the scheduling and/or detection order may be modified in real-time. The scheduling schedule and/or detection order may be modified based on one or more detected conditions, one or more additional processes to be run, one or more processes that are no longer to be run, one or more processes to be modified, one or more resource/component utilization modifications, one or more detected error or alarm conditions, unavailability of one or more resources and/or components, one or more subsequent inputs or samples provided by a user, external data, or any other reason.

In some examples, one or more additional samples may be provided to the device after one or more initial samples are provided to the device. The additional samples may be from the same subject or different subjects. The additional sample may be the same type of sample as the initial sample or a different type of sample (e.g., blood, tissue). Additional samples may be provided before, after, and/or simultaneously with processing one or more initial samples on the device. Additional samples may be provided with the same and/or different detection or desired criteria relative to each other and/or the initial sample. The additional sample may be processed sequentially and/or in parallel with the initial sample. The additional sample may use one or more of the same components as the initial sample, or may use different components. Additional samples may or may not be needed in view of one or more detected conditions of the initial sample.

In some embodiments, the system receives the sample by means of a sample collection module, such as a lancet, scalpel, or fluid collection vessel. The system then loads or takes the solution to execute one or more of the processing routines from the plurality of potential processing routines. In one example, the system is loaded with a centrifugation protocol and a cell counting protocol. In some embodiments, the protocol can be loaded from an external device to the sample processing device. Alternatively, the protocol may already be on the sample processing device. The schema may be generated based on one or more desired criteria and/or processing routines. In one example, generating the schema can include generating a list of one or more subtasks for each input procedure. In some embodiments, each subtask is to be performed by a single component of one or more devices. Generating the schema may also include generating an order for the list, timing, and/or allocating one or more resources.

In one embodiment, the protocol provides details or instructions specific to the sample or components in the sample. For example, a centrifugation protocol may include a rotation rate and processing time suitable for a predetermined sample density that supports density-dependent separation of the sample from other materials that may be present with the desired components of the sample.

The recipe is contained in the system, such as in a recipe repository of the system, or retrieved from another system (such as a database) in communication with the system. In one embodiment, the system is in one-way communication with a database server that provides solutions to the system upon request by the system for one or more processing solutions. In another embodiment, the system is in two-way communication with the database server, which enables the system to upload the user-specific processing routine to the database server for future use by the user or other users who may use the user-specific processing routine.

Referring now to fig. 56A and 56B, transport container 4000 may be configured for containing therein a plurality of bodily fluid samples from a plurality of subjects (such as patients). In some embodiments, there are multiple vessels of samples from each subject. Optionally, at least two of the samples from the same subject have different chemical pretreatments, such as, but not limited to, different anticoagulants in each vessel. Alternatively, some embodiments may use a vessel having two or more separate chambers, wherein each chamber is configured to contain a portion of the fluid sample separate from the fluid sample in another chamber. Some embodiments may comprise a sample from a subject in a single chamber vessel and/or a multi-chamber vessel.

As seen in fig. 56A and 56B, various views of one embodiment of a transport container 4000 are shown, where a cover plate 4010 has at least one deck portion 4012 sized to fit into a recess 4020 on the bottom of the transport container 4000, as seen in fig. 57A, so that the vessels 4000 may be stackable. The shipping container 4000 may have any of the features described herein with respect to other embodiments of the shipping container described herein.

Fig. 57B illustrates that there may be a tray 4030 in shipping container 4000, which tray 4030 is fixed and/or removable from shipping container 4000. In one embodiment, tray 4030 is held in place by a fixture, such as but not limited to a magnetic or metal portion 4032 that aligns with a metal or magnetic portion in the chassis of transport container 4000 to form a magnetic connection. In some embodiments, the aspect ratio of the length to the width is in the range of about 128:86 to 127: 85. Optionally, the aspect ratio of the length to the width is in a range of about 130:90 to 120: 80. Optionally, the length of the tray is in the range of about 130mm to 120mm and the width is in the range of about 90mm to 80 mm. In some embodiments, the height or thickness of the tray is in the range of about 14 to 20 mm. The aspect ratio and/or size is configured to accommodate a tray sized to fit a slot, pocket, or other holder on a plate centrifuge. In this manner, the entire tray 4030 can be centrifuged to prepare multiple samples located therein.

As seen in fig. 57A and 57B, tray 4030 has a plurality of slots 4034, wherein slots 4034 are sized to receive at least one sample storage vessel. At least one portion 4040 of the slot 4034 has a first shape and at least a second portion 4042 has a second shape different from the first shape, wherein the shapes are dimensioned in such a way that the sample vessel can only be inserted into the slot 4034 in a desired orientation. As seen in fig. 58B, one end is semi-circular and the other end is asymmetrically shaped. Tray 4030 may also be molded with a cutout 4036 or other shape so that tray 4030 can only be inserted into shipping container 4000 in one orientation. It should also be understood that the tray 4030 may be held in a tray such that a user cannot use his fingers to remove the tray from the vessel 4000 without the use of a tool or other tray extraction device. This minimizes the risk of tampering by the user. Tray 4030 may be configured to be retained in shipping container 4000 even when shipping container 4000 is inverted and may resist the pull of earth gravity.

Fig. 59A and 59B show still another embodiment in which a plurality of slots 4100 are present in the tray 4102. The trays have different aspect ratios (closer to square) and have a plurality of shaped slots in the trays to accommodate the sample vessels.

In at least some embodiments, the healthcare provider (or staff thereof, as appropriate) may be the sample collector, the test result recipient, and/or both. For example, in one embodiment, a healthcare professional, such as but not limited to a dentist, can collect a sample as part of or independent of a dental procedure. Alternatively, some embodiments may collect a sample from blood and/or saliva drawn from a dental procedure of a subject. The collected samples may be processed in a dental office and/or transported to a receiving location where a plurality of samples are received for processing.

In embodiments, a bodily fluid sample used in a system, device, or method provided herein can be diluted. In embodiments, the bodily fluid sample may be diluted before it is transported from the first location to the second location. In embodiments, the bodily fluid sample may be diluted after it is transported from the first location to the second location. In embodiments, the bodily fluid sample may be diluted both before and after it is transported from the first location to the second location. In embodiments, the bodily fluid sample may be diluted after it is transported from the first location to the second location and before it is used at the second location for performing one or more steps of a laboratory test. The original bodily fluid sample may, for example, be diluted at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000, or 100,000-fold. As used herein, "n-fold" dilution means the proportion of the original sample that is diluted-e.g., the 5-fold diluted original sample contains the original sample at a concentration of 1/5 of its original concentration after dilution (i.e., the diluted sample contains the sample at a concentration of 1/5 of the concentration of the sample in the original sample); similarly, the original sample diluted 500 times contained the original sample at a concentration of 1/500 that was the original concentration after dilution. Thus, for example, if the original sample contains 5mg of protein per microliter and is diluted 2-fold, the diluted sample contains 2.5mg of protein per microliter. The bodily fluid sample may be divided into any number of portions, and each portion may be diluted to a different dilution, so that the original bodily fluid sample may be processed to obtain a plurality of diluted samples, each sample having a different dilution. Thus, for example, the original body fluid sample may be divided into 5 portions, with one portion diluted 8-fold, another portion diluted 12-fold, another portion diluted 3-fold, another portion diluted 400-fold, and another portion diluted 2,000-fold. Dilution of the sample may be performed continuously or in a single step. For single step dilution, a selected amount of sample may be mixed with a selected amount of diluent in order to achieve the desired dilution of the sample. For serial dilution, two or more separate serial dilutions of the sample may be performed in order to achieve the desired sample dilution. For example, a first dilution of the sample may be performed, and a portion of the first dilution may be used as input material for a second dilution to yield the sample at a selected degree of dilution.

For the dilutions described herein, "raw sample" and the like refer to the sample used at the beginning of a given dilution process. Thus, while the "raw sample" may be a sample obtained directly from a subject (e.g., whole blood), it may also include any other sample used as a starting material for a given dilution process (e.g., a sample that has been processed or that has been previously diluted in a separate dilution process).

In some embodiments, serial dilution of the sample may be performed as described below. A selected amount (e.g., volume) of the original sample can be mixed with a selected amount of diluent to obtain a first diluted sample. The first diluted sample (and any subsequent diluted samples) will have: i) a sample dilution factor (e.g., the fold by which the original sample was diluted in the first diluted sample) and ii) an initial amount (e.g., the total amount of the first diluted sample present after combining the selected amount of the original sample with the selected amount of diluent). For example, 10 microliters of the original sample can be mixed with 40 microliters of diluent to obtain a first diluted sample having a 5-fold sample dilution factor (compared to the original sample) and an initial amount of 50 microliters. Next, a selected amount of the first diluted sample may be mixed with a selected amount of diluent to obtain a second diluted sample. For example, 5 microliters of a first diluted sample can be mixed with 95 microliters of diluent to yield a second diluted sample having a 100-fold dilution factor (compared to the original sample) and an initial amount of 100 microliters. For each of the dilution steps described above, the original sample, one or more diluted samples, and diluent may be stored or mixed in a fluidly isolated vessel. Serial dilution may be continued as necessary for several steps in the manner previously described to achieve a selected sample dilution level/dilution factor. For example, in an embodiment, the sample may be diluted as described in U.S. patent application serial No. 13/769,820 filed on 2013, 2, 18, or any other document incorporated by reference elsewhere herein.

As used herein, a reagent that is or can be used as a "diluent" is a reagent that, for example, helps to increase the volume of a sample or a portion of a sample, or that helps in the preparation of a liquid formulation (such as a formulation reconstituted after lyophilization), or that is used to add to a sample, solution, or material for any other reason. In embodiments, the diluent may be buffered (e.g., so as to have a pH near pH 7 or near pH 7.4 or other desired pH) and may be pharmaceutically acceptable (safe and non-toxic for human administration). The diluent does not typically react or bind with the analyte in the sample. Water may be a diluent, and an aqueous saline solution, a buffer solution, a surfactant-containing solution, or any other solution may also be a diluent. Exemplary diluents include sterile water, bacteriostatic water for injection (BWFI), pH buffered solutions (e.g., phosphate buffered saline), sterile saline solution, ringer's solution, or dextrose solution. In embodiments, the diluent may comprise an aqueous solution of a salt or a buffer.

In embodiments, a bodily fluid sample or portion thereof collected, processed, or transported from a subject, e.g., according to a system or method provided herein, can be divided into 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 distinct portions. For the description provided herein of dividing a sample into portions, "raw sample" and the like refer to the sample used at the beginning of a given sample dispensing process. Thus, while the "raw sample" may be, for example, a sample obtained directly from a subject (e.g., whole blood), it may also include any other sample used as a starting material for a given sample dispensing process (e.g., a sample that has been processed or that has previously been dispensed in a separate sample dispensing process). In embodiments, the "raw sample" may be subjected to sample dispensing and dilution steps; in such cases, reference to "raw sample" refers to the starting material used for the combined sample dilution/sample dispensing process. When the sample is divided into different portions, the different portions may comprise different amounts of the original sample. For example, if an original sample having a volume of 100 microliters is divided into 5 portions, one portion may contain 50 microliters of the original sample, another portion may contain 25 microliters of the original sample, another portion may contain 15 microliters of the original sample, another portion may contain 8 microliters of the original sample, and the last portion may contain 2 microliters of the original sample. Likewise, when the sample is both diluted and separated into different portions, the different portions may have different dilutions relative to the original sample. For example, if the original sample is divided into three portions, one portion may be diluted 5-fold relative to the original sample, another portion may be diluted 20-fold relative to the original sample, and a third portion may be diluted 200-fold relative to the original sample.

Thus, in an example, a bodily fluid sample may be collected from a subject at a first location (e.g., a sample collection site). A bodily fluid sample initially collected from a subject may be considered an "original sample". Such a "raw sample" may be, for example, a small amount (e.g., less than 400, 300, 200, or 100 microliters) of whole blood from a subject. Shortly after or concurrently with collecting the "raw sample" from the subject, the "raw sample" may be separated into at least a first portion and a second portion, after which the first portion is transferred into a first vessel and the second portion is transferred into a second vessel. In embodiments, the first vessel may comprise a first anticoagulant (e.g., EDTA) and the second portion may comprise a second anticoagulant (e.g., heparin). The first and second vessels may be transported from a first location to a second location according to the systems or methods provided herein. In embodiments, at the second location, the sample or portion thereof in one or both of the vessels may be subjected to further processing or analysis steps. For example, the sample or a portion thereof in one or both of the vessels may be divided into additional portions, diluted, and/or used to perform one or more assays.

In another example, a bodily fluid sample may be transported in a vessel from a first location to a second location according to the systems and methods provided herein. The bodily fluid sample in the vessel may be the entire sample collected from the subject, or a portion thereof. At the second location, at least some of the bodily fluid sample in the vessel may be removed from the vessel and used in a sample dispensing and/or dilution process. A sample removed from a vessel and used in a sample dispensing and/or dilution process may be considered an "original sample". The raw sample may be, for example, whole blood, plasma, serum, saliva or urine, and may constitute all or a portion of the sample transported in the vessel. The original sample may be divided into any number of portions; each portion may have a different dilution with respect to the original sample. For example, the original sample removed from the shipping vessel can have a volume of less than or equal to 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, or 1 microliters. The original sample removed from the transport vessel may then be divided into 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 different portions. In embodiments, the different portions may have different dilutions relative to the original sample. For example, the different portions may have different dilutions of at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, or 5,000 relative to the original sample, provided that the number of portions having different dilutions does not exceed the total number of portions prepared from the original sample. The different portions may have any type of dilution relative to the original sample, including, for example, no dilution, at least 2-fold dilution, at least 3-fold dilution, at least 5-fold dilution, at least 10-fold dilution, at least 20-fold dilution, at least 50-fold dilution, at least 100-fold 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 portions of the original sample may be used for laboratory testing. In embodiments, a portion of the original sample may be used for a laboratory test. A portion of the original sample used for laboratory testing may be a diluted sample.

In embodiments, the raw sample may be a whole blood sample obtained from the subject. The original sample may be obtained from a subject's digit. The original sample can have a volume of no more than 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 1 microliters. The original sample may be divided into a plurality of portions. The separation of the sample into multiple portions may occur before, after, or a combination of before and after the transport of the sample from the first location to the second location in accordance with the systems or methods provided herein. In embodiments, the raw sample may be divided into 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 different portions, and the different portions are used to perform 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 different laboratory tests. Different portions of the original sample may have diluted original samples. In embodiments, no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05, or 0.01 microliters of the original sample is used per laboratory test.

In embodiments, the raw sample may be plasma or serum obtained from a whole blood sample obtained from the subject. Whole blood may be obtained from the subject's digit. The whole blood from which the plasma or serum is obtained may have a volume of no more than 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 1 microliter. The plasma or serum raw sample may have a volume of no more than 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliter. The original sample may be divided into a plurality of portions. The separation of the sample into multiple portions may occur before, after, or a combination of before and after the transport of the sample from the first location to the second location in accordance with the systems or methods provided herein. In embodiments, the raw sample may be divided into 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 different portions, and the different portions are used to perform 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 different laboratory tests. Different portions of the original sample may have diluted original samples.

In embodiments, the laboratory test is performed using an equivalent weight (equivalent) of the original sample of no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05, or 0.01 microliters. For example, if the original sample is whole blood and the original sample is divided into portions and at least one portion contains a diluted sample containing the original sample that has been diluted 100 times and a laboratory test is performed using 5 microliters of the diluted sample, the test is performed using an equivalent of 0.05 microliters of the original sample (e.g., whole blood) (5 microliters x1/100 dilution). In another example, the raw sample may be whole blood. The whole blood may be processed to obtain plasma [ e.g., by separating the liquid components of the blood from the solid components (e.g., cells) of the blood ]. A volume of plasma may be obtained from a volume of whole blood-for example, the volume of plasma that may be obtained from a volume of whole blood may be at least or about 30%, 40%, 50%, 60%, or 70% of the volume of whole blood, for example. Thus, for example, if the volume of plasma from whole blood is 50%, 1ml of plasma can be obtained from 2ml of whole blood. Plasma from whole blood may be further diluted and one or more laboratory tests may be performed using one or more diluted portions of plasma. In another example, the raw sample may be whole blood. Whole blood may be processed to obtain plasma, where the volume of plasma from whole blood is 60% of whole blood (e.g., 60 microliters of plasma obtained from 100 microliters of whole blood). Plasma can be diluted 10-fold. Laboratory tests can be performed using 2 microliters of diluted plasma. Thus, for the laboratory test, the test was performed using an equivalent of about 0.33 microliters of the original sample (whole blood) (2 microliters x1/10 dilution x 100/60 whole blood/plasma conversion). In another example, the original sample may be plasma, and the original sample may be divided into a plurality of portions, and at least one portion contains a diluted sample containing the original sample that has been diluted 50-fold, and a laboratory test is performed using 4 microliters of the diluted sample, the test being performed using an equivalent of 0.08 microliters of the original sample (e.g., plasma) (4 microliters x1/50 dilution).

In embodiments, the raw sample may be divided into 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 different portions, and the different portions may be used to perform 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 different laboratory tests. In some embodiments, at least as many sample portions as there are laboratory tests performed on a portion of a sample are prepared (e.g., to perform 10 laboratory tests with an original sample, the original sample can be divided into at least 10 portions, at least 1 portion for each test). In certain other embodiments, more than one laboratory test may be performed with a single sample. For example, in embodiments, an optical property of a sample (e.g., a cell count in a blood sample) may be measured, and the same sample may then be used to determine an analyte in the blood. Thus, in some embodiments, more laboratory tests may be performed on a raw sample than the number of fractions prepared from the same raw sample (e.g., 10 laboratory tests may be performed from a raw sample that is only divided into 8 fractions).

When the original sample is divided into a plurality of portions and the plurality of portions are used to perform two or more laboratory tests, the laboratory tests may be the same type of laboratory test or they may be different types of laboratory tests. For example, if the original sample is divided into 10 portions, and the 10 portions are each used for laboratory testing, the laboratory testing performed with each of the portions may be an immunoassay. In another example, if the original sample is divided into 5 portions, and the 5 portions are each used for laboratory testing, the laboratory testing performed with each of the portions may be nucleic acid amplification based testing.

In other cases, when the original sample is divided into multiple portions and the multiple portions are used to perform two or more laboratory tests, at least two of the laboratory tests may be different types of laboratory tests. For example, if the original sample is divided into 5 portions, and the 5 portions are each used for laboratory testing, then 2 of the portions may be used for immunoassays (e.g., ELISA) and 3 of the portions may be used for nucleic acid amplification based testing.

A bodily fluid sample or portion thereof transported according to the systems or methods provided herein can be used for various types of laboratory testing, such as immunoassays, nucleic acid amplification assays, general chemical assays, or cytometric assays. In embodiments, a bodily fluid sample, or portion thereof, transported according to the systems or methods provided herein may be used in any type of assay or laboratory test described, for example, in U.S. patent application serial No. 13/769,820 filed on 2013, 2, 18, or any other document incorporated by reference elsewhere herein.

In some embodiments, a sample of bodily fluid or portion thereof transported according to the systems or methods provided herein can be used in an immunoassay. As used herein, "immunoassay" refers to any assay that involves detecting an analyte with an antibody having affinity for the analyte. Immunoassays may include, for example, enzyme-linked immunosorbent (ELISA) assays, and may include competitive and non-competitive based assays. The term "antibody" as used herein refers to immunoglobulin molecules and immunologically active portions of immunoglobulin molecules, i.e., molecules that comprise an antigen binding unit ("Abu" or "Abus") that specifically binds to (is "immunoreactive with") an antigen. Structurally, the simplest naturally occurring antibody (e.g., IgG) comprises 4 polypeptide chains — two heavy (H) chains and two light (L) chains, which are linked by disulfide bonds. Immunoglobulins represent a large family of molecules, which include several types of molecules, such as IgD, IgG, IgA, IgM, and IgE. The term "immunoglobulin molecule" includes, for example, hybrid or altered antibodies, and fragments thereof. Based on their molecular structure, antigen-binding units can be broadly divided into "single-chain" ("Sc") and "non-single-chain" ("Nsc") types.

Immunoglobulin molecules and fragments thereof are also encompassed by the terms "antibody" and "antigen-binding unit", which may be human, non-human (derived from vertebrate or invertebrate), chimeric or humanized. For a description of the concept of chimeric and humanized antibodies, see Clark et al, 2000 and the references cited therein (Clark, (2000) immunological. today 21: 397-402). In embodiments, an "immunoassay" as provided herein may also include an assay in which the analyte to be measured in the assay is an antibody, and the antibody is probed with a molecule having affinity for the antibody (e.g., a target molecule of the antibody).

In some embodiments, a bodily fluid sample or portion thereof transported according to the systems or methods provided herein can be used in a nucleic acid amplification assay. As used herein, "nucleic acid amplification assay" refers to an assay in which the copy number of a target nucleic acid can be increased. Nucleic acid amplification assays can include isothermal and temperature variable amplification techniques, and include, for example, techniques such as Polymerase Chain Reaction (PCR) and loop-mediated isothermal amplification (LAMP). Typically, a nucleic acid amplification assay comprises at least i) a nucleic acid polymerase, ii) a primer that can bind to a target nucleic acid sequence, and iii) free nucleotides that can be incorporated into the synthesized nucleic acid by the polymerase. Amplification of a target nucleic acid can be detected in various ways, such as measuring the fluorescence or turbidity of the reaction over a period of time.

In some embodiments, a bodily fluid sample or portion thereof transported according to the systems or methods provided herein can be used in a general chemical assay. Common chemical assays may include, for example, assays for basal Metabolic function group (Basic Metabolic Panel) [ glucose, calcium, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, Blood Urea Nitrogen (BUN) ], assays for Electrolyte (Electrolyte Panel) [ sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate) ], assays for Chem 14 group/Comprehensive Metabolic function group (Chem 14Panel/Comprehensive Metabolic Panel) [ glucose, calcium, albumin, total protein, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, Blood Urea Nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), total bilirubin ], and the like, The measurement of blood Lipid Profile/blood Lipid group (Lipid Profile/Lipid Panel) [ LDL cholesterol, HDL cholesterol, total cholesterol and triglyceride ], the measurement of Liver group/Liver Function (Liver Panel/Liver Function) [ alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), total bilirubin, albumin, total protein, gamma-glutamyltransferase (GGT), Lactate Dehydrogenase (LDH), Prothrombin Time (PT) ], alkaline phosphatase (APase), hemoglobin, VLDL cholesterol, ethanol, lipase, pH, protoporphyrin zinc, direct bilirubin, blood type (ABO, RHD), lead, phosphate, hemagglutination inhibition, magnesium, iron uptake, fecal occult blood, and the like, alone or in any combination.

In a general chemical assay provided herein, in some examples, the level of an analyte in a sample is determined by one or more assay steps involving the reaction of the analyte of interest with one or more reagents, causing a detectable change in the reaction (e.g., a change in turbidity of the reaction, the production of luminescence in the reaction, a change in color of the reaction, etc.). In some examples, the properties of the sample are determined by one or more assay steps involving reaction of the sample of interest with one or more reagents, causing a detectable change in the reaction (e.g., a change in turbidity of the reaction, production of luminescence in the reaction, a change in color of the reaction, etc.). Generally, as used herein, a "generic chemical" assay does not involve amplification of nucleic acids, imaging of cells at the microscopy stage, or determination of analyte levels in solution based on the use of labeled antibodies/conjugates to determine analyte levels in solution. In some embodiments, a common chemical assay is performed with all reagents in a single vessel-in order to perform the reaction, all necessary reagents are added to the reaction vessel, and during the course of the assay, no material is removed from the reaction or reaction vessel (e.g., no washing step; it is a "mix and read" reaction). Common chemical assays may also be, for example, colorimetric assays, enzymatic assays, spectroscopic assays, turbidimetric assays, agglutination assays, coagulation assays, and/or other types of assays. Many common chemical assays can be analyzed by measuring the absorbance of light at one or more selected wavelengths by the assay reaction (e.g., measured with a spectrophotometer). In some embodiments, common chemical assays can be analyzed by measuring the turbidity of the reaction (e.g., measured with a spectrophotometer). In some embodiments, common chemical assays can be analyzed by measuring the chemiluminescence produced in the reaction (e.g., measured with a PMT, photodiode, or other optical sensor). In some embodiments, common chemical assays may be performed by calculation based on experimental values determined for one or more other analytes in the same or related assay. In some embodiments, the fluorescence of a reaction can be measured (e.g., with a detection unit that contains or is linked to i) a light source of one or more specific wavelengths ("excitation wavelengths"); and ii) a sensor configured to detect emitted light at one or more specific wavelengths ("excitation wavelengths") to analyze common chemical assays. In some embodiments, common chemical assays can be analyzed by measuring agglutination in the reaction (e.g., by measuring the turbidity of the reaction with a spectrophotometer or by obtaining an image of the reaction with an optical sensor). In some embodiments, common chemical assays can be analyzed by imaging the reaction at one or more time points (e.g., imaging with a CCD or CMOS optical sensor) followed by image analysis. Alternatively, the analysis may involve prothrombin time, Activated Partial Thromboplastin Time (APTT), any of which may be measured by methods such as, but not limited to, nephelometry. In some embodiments, common chemical assays can be analyzed by measuring the viscosity of the reaction (e.g., with a spectrophotometer, where an increase in the viscosity of the reaction changes the optical properties of the reaction). In some embodiments, a common chemical assay may be analyzed by measuring complex formation between two non-antibody reagents (e.g., metal ions and chromophores; such reactions may be measured spectrophotometrically or by colorimetric methods using another device). In some embodiments, common chemical assays can be analyzed by non-ELISA or cell count based methods for determining cellular antigens (e.g., hemagglutination assays for blood types, which can be measured by, for example, turbidity of the reaction). In some embodiments, common chemical assays may be analyzed with the aid of electrochemical sensors (e.g., electrochemical sensors for carbon dioxide or oxygen). Additional methods may also be used to analyze common chemical assays.

In some embodiments, a spectrophotometer may be used to measure common chemical assays. In some embodiments, the common chemical assay may be measured at the end of the assay ("endpoint" assay) or at two or more times during the course of the assay ("time course" or "kinetic" assay).

In some embodiments, a bodily fluid sample or portion thereof transported according to the systems or methods provided herein can be used in a cytometric assay. Cytometry assays are commonly used to optically, electrically, or acoustically measure characteristics of individual cells. For purposes of the present disclosure, "cells" may comprise non-cellular samples that are generally similar in size to individual cells, including but not limited to vesicles (e.g., liposomes), small populations of cells, virosomes, bacteria, protozoa, crystals, entities formed by the polymerization of lipids and/or proteins, and substances bound to small particles such as beads or microspheres. Such features include, but are not limited to, size; a shape; particle size; light scattering pattern (or optical characteristic curve); whether the cell membrane is intact; concentration, morphology and spatiotemporal distribution of intracellular contents including, but not limited to, protein content, protein modifications, nucleic acid content, nucleic acid modifications, organelle content, nuclear structure, nuclear content, intracellular structure, internal vesicle content (including pH), ionic concentration and presence of other small molecules such as steroids or drugs; and cell surface (both cell membrane and cell wall) markers including proteins, lipids, carbohydrates, and modifications thereof. Cell counts can be used to determine the presence, amount, and/or modification of particular proteins, nucleic acids, lipids, carbohydrates, or other molecules by using appropriate dyes, stains, or other labeling molecules, whether in pure form, coupled to other molecules, or immobilized or bound to nanoparticles or microparticles. Cytometric analysis can be performed by, for example, flow cytometry or microscopy. Flow cytometry typically uses a flowing liquid medium that in turn carries individual cells to an optical, electrical, or acoustic detector. Microscopy typically uses optical or acoustic means to detect fixed cells, typically by recording at least one magnified image. In embodiments, a cytometric assay may involve obtaining an image of one or more cells in a sample. In embodiments, the sample may be provided on or in a microscope slide or cuvette that may allow cells in the sample to settle in a desired configuration for imaging. Images of the cells may be obtained with a camera, e.g., based on CCD or CMOS.

In some embodiments, the laboratory test type may be classified based on how the results of the test are detected. Different types of laboratory test result detection 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 serial No. 13/769,820 filed on 2013, 2/18, which is hereby incorporated in its entirety for all purposes. In short, luminescence can be detected from detection that produces a measurable light signal. Such a reaction may be, for example, a chemiluminescent reaction. To detect the result of the luminescence reaction, a light detector, such as a PMT or photodiode, may be used to detect light from the measurement unit containing the luminescence reaction. The fluorescence may be detected, for example, with an optical device that includes a light source and a light detector. The light source may emit light at one or more specific wavelengths. The assay unit containing the detection material may be positioned in the path of the light source such that the one or more specific wavelengths of light reach the contents of the assay unit (one or more "excitation wavelengths"). The assay unit may contain a molecule of interest that, at least in some cases, absorbs light at one or more specific wavelengths from the light source and subsequently releases light at a different wavelength. The light detector may be configured to detect light (one or more "emission wavelengths") released by the molecule of interest. The light source and/or the light detector may include a band pass filter after the light source or before the light detector in order to limit one or more wavelengths of light from the light source or to the light detector. The light source may be, for example, a light bulb, a laser, or an LED, and the light detector may be, for example, a PMT or photodiode. The absorbance may be detected, for example, with an optical device comprising a light source and a light detector. The light source and the light detector may be in line with each other and configured such that an assay unit containing a detection material may be located between the light source and the light detector such that some light may pass through the detection material to the light detector and some light may be absorbed. Based on the results of the detection, different amounts of light may be absorbed by the detection material. Similarly, the light transmission through the detection material can be determined. For absorption/transmission determination measurements, one or more wavelengths of light emitted by the light source may be the same as one or more wavelengths of light detected by the light detector. The light source may be, for example, a light bulb, a laser, or an LED, and the light detector may be, for example, a PMT or photodiode. The light scattering may be detected, for example, with an optical device comprising a light source and a light detector. The light source and the light detector may be angled with respect to each other and configured such that a measurement cell containing the detection material may be simultaneously in line with the light source and the light detector such that light from the light source may reach the measurement cell and be scattered by the detection material in the measurement cell to reach the light detector. Based on the results of the detection, different amounts of light may be scattered by the detection material. The light source may be, for example, a light bulb, a laser, or an LED, and the light detector may be, for example, a PMT or photodiode. The image of the detection material may be obtained, for example, by a detector including an image sensor (e.g., a CCD or CMOS sensor). Typically, the image sensor will be included in the camera. The image of the detection material may be analyzed, for example, by automated or manual image analysis, to determine the detection result. Bodily fluid samples provided herein can also be used for laboratory testing of results by non-optically based detection methods (e.g., measuring conductivity, radioactivity, or temperature).

In embodiments, to perform an assay/detection with a portion of a bodily fluid sample, the portion of the bodily fluid sample may be transferred to an assay unit for at least one step in the assay/detection. The assay unit can have various form factors, such as a pipette tip, a tube, or a microscope slide. The steps of the assay that may occur in the assay unit may include, for example, binding of an analyte in the sample to a binder (e.g., an antibody) for the analyte, amplification of a target nucleic acid in the sample in a nucleic acid amplification reaction, sample coagulation based on the addition of one or more reagents to the sample, or sample employing a configuration for optical analysis (e.g., sedimentation of cells onto the surface of a microscope slide in order to facilitate obtaining one or more images of the cells). As used herein, the terms "determining" and "detecting" are used interchangeably unless the context clearly dictates otherwise.

Examples

The following examples are provided for illustrative purposes only and are not intended to limit the present disclosure in any way.

Example 1

A whole blood sample is obtained from a subject. The whole blood sample is centrifuged in a vessel to separate the whole blood into precipitated cells and plasma supernatant. The centrifuged vessel was moved to an argon purged glove box. Aspirating and then aliquoting plasma from the centrifuged vessels into 5 separate sample vessels as provided herein, wherein the sample vessels each have an internal volume of no greater than 100 microliters, wherein no greater than 95 microliters of plasma is aliquoting into each sample vessel, and wherein each sample vessel is of the same size and receives the same volume of plasma. The vessels each had a removable butyl cap. The 5 sample vessels were associated with labels "0 hours", "1 hour", "2 hours", "8 hours" and "24 hours". An assay for bicarbonate is performed on the samples in each vessel at the respective time period associated with each sample vessel. The results of the assay are provided below in table 1.

TABLE 1

As shown in table 1, in the sample vessels provided herein, the bicarbonate in the samples was stable for at least 24 hours.

Example 2

A whole blood sample is obtained from a subject. EDTA was mixed with the whole blood sample. 80 microliters of EDTA-containing blood was aliquoted into each of the 10 sample vessels as provided herein, wherein each sample vessel had an internal volume of no greater than 100 microliters and had the same size. The sample vessels were associated with the following labels for analysis: real-time: day 1, day 2, day 3, day 4, day 5 and day 7; pre-centrifugal separation: day 1, day 2, day 4 and day 7. Each "pre-centrifuged" vessel is centrifuged to generate plasma and pelleted cells as the sample is aliquoted into the vessel. Each "real-time" vessel was centrifuged during the corresponding day to generate plasma and pelleted cells. After the sample was aliquoted into each sample vessel, it was capped. On the respective day for each vessel, plasma was removed from the vessel and assayed for Blood Urea Nitrogen (BUN). The BUN assay results are shown in the graph of fig. 48. As shown in this graph, in the sample vessels provided herein, BUN in the sample remained stable for at least 7 days, in both whole blood and plasma samples.

The publications discussed or illustrated herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited. The following applications are hereby incorporated by reference in their entirety for all purposes: U.S. provisional patent application No. 61/435,250 ("SYSTEMS AND method for same USE maximum) and U.S. patent publication No. 2009/0088336 (" MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USEs thermal "), filed on 21/1/2011. The following applications are also incorporated herein by reference in their entirety for all purposes: U.S. patent publication 2005/0100937, U.S. patent 8,380,541; U.S. patent application serial No. 61/766,113 filed on 18/2/2013; U.S. patent application serial No. 13/769,798 filed on 18/2/2013; U.S. patent application serial No. 13/769,779 filed on 18/2/2013; U.S. patent application serial No. 13/769,820 filed on 18/2/2013; U.S. patent application serial No. 13/244,947 filed on 26/9/2011; PCT/US2012/57155 filed on 9, 25/2012; U.S. application serial No. 13/244,946 filed on 26/9/2011; U.S. patent application 13/244,949 filed on 26/9/2011; and U.S. application serial No. 61/673,245, filed on 26/9/2011, the disclosures of which are all hereby incorporated by reference in their entirety.

Detailed description of the preferred embodiments

In one embodiment described herein, there is provided a device for collecting a bodily fluid sample from a subject, comprising: at least two sample collection pathways configured to draw the bodily fluid sample into the device from a single end of the device in contact with the subject, thereby separating the fluid sample into two separate samples; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway, whereupon when fluid communication is established, the vessels provide motive force to move a majority of the two separated samples from the pathway into the vessels.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion comprising at least one fluid collection site leading to at least two sample collection pathways configured for drawing a fluid sample therein via a first type of motive force; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway whereupon, when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the pathway into the vessels; wherein at least one of the sample collection pathways includes a fill indicator for indicating when a minimum fill level is reached and may engage at least one of the sample vessels to be in fluid communication with at least one of the sample collection pathways.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion comprising at least two sample collection channels configured to draw a fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an internal coating designed to mix with a fluid sample and another of the sample collection channels has another internal coating that is chemically different from the internal coating; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessels; wherein the vessels are arranged such that mixing of the fluid sample between the vessels does not occur.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, wherein the sample vessels have a first condition in which the sample vessels are not in fluid communication with the sample collection channel and a second condition in which the sample vessels are operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move the bodily fluid sample from the channel into the vessels.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action; and (b) a sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; wherein the second opening is defined by a portion of the collection channel that is configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel, and the sample vessel has an internal volume that is no greater than ten times an internal volume of the collection channel.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action; (b) a sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) an adapter channel configured to provide a fluid flow path between the collection channel and the sample vessel, having a first opening configured to contact the second opening of the collection channel and a second opening configured to penetrate the cap of the sample vessel.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening; (b) a base comprising a sample vessel for receiving the bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) a bracket, wherein the body and the base are connected to opposite ends of the bracket, and are configured to be movable relative to each other such that the sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the expanded state of the device than in the compressed state, the second opening of the collection channel being configured to penetrate the cap of the sample vessel, in the extended state of the device, the second opening of the collection channel is not in contact with the interior of the sample vessel, and in the compressed state of the device, the second opening of the collection channel extends through the cap of the vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening; (b) a base comprising a sample vessel for receiving a bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; (c) a support, and (d) an adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel, and the second opening configured to penetrate the cap of the sample vessel, wherein the body and the base are connected to opposing ends of the support and are configured to be movable relative to each other such that a sample collection device is configured to have an expanded state in which at least a portion of the base is closer to the body than in the compressed state of the device, and a compressed state in which the adapter channel is not in contact with one or both of the collection channel and the interior of the sample vessel, and in the compressed state of the device, the first opening of the adapter channel 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 vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a device for collecting a fluid sample from a subject, comprising: (a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening; (b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; wherein the second opening of the collection channel is configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a device for collecting a fluid sample from a subject, comprising: (a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening; (b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) an adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel, and the second opening configured to penetrate the cap 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. By way of non-limiting example, the body may include two collection channels. Optionally, the interior of one or more of the collection channels is coated with an anticoagulant. Optionally, the body comprises a first collection channel and a 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 of a light transmissive material. Optionally, the device comprises the same number of sample vessels as collection channels. Optionally, the device comprises the same number of adapter channels as collection channels. Optionally, the base comprises an optical indicator that provides a visual indication of whether the sample has reached the sample vessel in the base. Optionally, the base is a window that allows a user to view the vessel in the base. Optionally, the stand comprises a spring, and the spring exerts a force such that the device is in the extended state when the device is in its natural state. Optionally, the second opening of the collection channel or the adapter channel is covered by a sleeve, wherein the sleeve does not prevent movement of bodily fluid from the first opening toward the second opening via capillary action. Optionally, the sleeve contains a vent hole. Optionally, each collection channel may accommodate a volume of no more than 500 uL. Optionally, each collection channel may accommodate a volume of no more than 200 uL. Optionally, each collection channel may accommodate a volume of no more than 100 uL. Optionally, each collection channel may accommodate a volume of no more than 70 uL. Optionally, each collection channel may accommodate a volume of no more than 500 uL. Optionally, each collection channel may accommodate a volume of no more than 30 uL. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 16 mm. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 8 mm. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 4 mm. Optionally, the inner perimeter is a circle. Optionally, the device comprises a first collection channel and a second collection channel, and the opening of the first channel is adjacent to the opening of the second channel, and the openings are configured for simultaneously collecting blood from a single drop of blood. Optionally, the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm. Optionally, each sample vessel has an internal volume no greater than twenty times greater than the internal volume of the collection channel with which it is engageable. Optionally, each sample vessel has an internal volume no greater than ten times the internal volume of the collection channel with which it is engageable. Optionally, each sample vessel has an internal volume no greater than five times greater than the internal volume of the collection channel with which it is engageable. Optionally, each sample vessel has an internal volume no greater than twice the internal volume of the collection channel with which it is engageable. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 90% of the bodily 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, establishment of fluidic communication between the collection channel and the sample vessel results in transfer of at least 95% of the bodily fluid sample in the collection channel into the sample vessel. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 98% of the bodily fluid sample in the collection channel into the sample vessel. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and retention of no more than 10uL of bodily fluid sample in the collection channel. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and retention of no more than 5uL of bodily fluid sample in the collection channel. Optionally, engagement of the collection channel with the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in no more than 2uL of bodily fluid sample remaining in the collection channel.

In another embodiment described herein, there is provided a method comprising: contacting one end of a sample collection device with a bodily fluid sample to separate the sample into at least two portions by drawing the sample into at least two collection channels of the sample collection device via a first type of motive force; after a desired amount of sample fluid has been confirmed to be in at least one of the collection channels, fluid communication is established between the sample collection channel and the sample vessels, whereupon the vessels provide a second motive force different from the first motive force to move each portion of bodily fluid sample into its respective vessel.

In another embodiment described herein, there is provided a method comprising: metering a minimum amount of sample into at least two channels by using a sample collection device having at least two of the sample collection channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force; after a desired amount of sample fluid has been confirmed to be in the collection channel, fluid communication is established between the sample collection channel and the sample vessel, whereupon the vessel provides a second motive force different from the first motive force to collect the sample to move the bodily fluid sample from the channel into the vessel.

In another embodiment described herein, there is provided a method of collecting a bodily fluid sample, comprising: (a) contacting a bodily fluid sample with a device comprising a collection channel comprising a first opening and a second opening and configured to draw bodily fluid from the first opening toward the second opening via capillary action such that the bodily fluid sample fills the collection channel from the first opening through the second opening; (b) establishing a fluid flow path between the collection channel and an interior of a sample vessel having an interior volume no greater than ten times an interior volume of the collection channel and having a vacuum prior to establishment of the fluid flow path between the collection channel and the interior of the sample vessel such that establishment of the fluid flow path between the collection channel and the interior of the sample vessel generates a negative pressure at the second opening of the collection channel and transfers a fluid sample from the collection channel to the interior of the sample vessel.

In another embodiment described herein, there is provided a method of collecting a bodily fluid sample, comprising: (a) contacting a bodily fluid sample with any collection device as described herein such that the bodily fluid sample fills the collection channel from the first opening through the second opening of at least one of the one or more collection channels in the device; and (b) establishing a fluid flow path between the collection channel and an interior of the sample vessel such that establishing a fluid flow path between the collection channel and the interior of the sample vessel generates a negative pressure at the second opening of the collection channel and transfers a fluid sample from the collection channel to 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 is not placed in fluid communication with the interior of the sample vessel until bodily fluid reaches the second opening of the collection channel. Optionally, the device comprises two collection channels and the collection channels are not placed in fluid communication with the interior of the sample vessel until bodily fluid reaches the second openings of both collection channels. Optionally, the second opening of the collection channel in the device is configured to penetrate the cap of the sample vessel, and wherein a fluid flow path between the second opening of the collection channel and the sample vessel is established by providing relative movement between the second opening of the collection channel and the sample vessel such that the second opening of the collection channel penetrates the cap of the sample vessel. Optionally, the device comprises an adapter channel for each collection channel in the device, the adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel and the second opening configured to penetrate the cap of the sample vessel, and wherein a fluid flow path between the collection channel and the sample vessel is established by providing relative movement between two or more of (a) the second opening of the collection channel, (b) the adapter channel, and (c) the sample vessel such that the second opening of the adapter channel penetrates the cap of the sample vessel.

In another embodiment described herein, there is provided a method for collecting a sample of bodily fluid from a subject, comprising: (a) placing a device comprising a first channel and a second channel in fluid communication with a bodily fluid from the subject, each channel having an input opening configured for fluid communication with the bodily fluid, each channel having an output opening downstream of the input opening of each channel, and each channel configured for drawing bodily fluid from the input opening toward the output opening via capillary action; (b) fluidly communicating the first and second channels with first and second vessels, respectively, through the output opening of each of the first and second channels; and (c) directing the bodily fluid within each of the first and second channels to each of the first and second vessels by means of: (i) a negative pressure in the first vessel or the second vessel relative to ambient pressure, wherein the negative pressure is sufficient to produce flow of the bodily fluid through the first channel or the second channel into its corresponding vessel, or (ii) a positive pressure upstream of the first channel or the second channel relative to ambient pressure, wherein the positive pressure is sufficient to produce flow of the whole blood sample through the first channel or the second channel into its corresponding vessel.

In another embodiment described herein, there is provided a method of making a sample collection device, comprising: forming a portion of a sample collection device having at least two channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force; forming a sample vessel, whereupon the vessel is configured for coupling to the sample collection device to provide a second motive force different from the first motive force to collect a sample to move a bodily fluid sample from the channel into the vessel.

In another embodiment described herein, computer-executable instructions are provided for performing a method comprising: forming part of a sample collection device having at least two channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force.

In another embodiment described herein, computer-executable instructions are provided for performing a method comprising: forming a sample vessel, whereupon the vessel is configured for coupling to the sample collection device to provide a second motive force different from the first motive force to collect a sample to move a bodily fluid sample from the channel into the vessel.

In yet another embodiment described herein, a device for collecting a bodily fluid sample from a subject, the device comprising: means for drawing said bodily fluid sample into said device from a single end of said device in contact with said subject, thereby dividing the fluid sample into two separate samples; means for transferring the fluid sample into a plurality of sample vessels, wherein the vessels provide motive force to move a majority of the two separated samples from the pathway into the vessels.

While the above is a complete description of the preferred embodiments as described herein, it is possible to use various alternatives, modifications, and equivalents. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. Any feature, whether preferred or not, may be combined with any other feature, whether preferred or not. The following claims should not be construed to include means-plus-function limitations unless such limitations are expressly set forth in a given claim using the phrase "means for …". It should be understood that as used throughout the description herein and the claims that follow, the meaning of "a," "an," and "the" includes plural referents unless the context clearly dictates otherwise. Furthermore, as used throughout the description herein and the claims that follow, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. Finally, as used throughout the description herein and the claims that follow, the meaning of "and" or "includes both conjunctive and disjunctive and may be used interchangeably unless the context clearly dictates otherwise. Thus, in the context of the use of the terms "and" or, "the use of such conjunctions does not exclude the meaning of" and/or "unless the context clearly dictates otherwise. The following U.S. patent applications are incorporated herein by reference for all purposes: 61/733,886 filed 12/5/2012, 61/875,030 filed 9/7/2013, and 61/875,107 filed 9/8/2013. This document contains material which is subject to copyright protection. The copyright owner (applicant herein) has no objection to the facsimile reproduction by anyone of the patent documents and disclosure, as it appears in the U.S. patent and trademark office patent file or records, but otherwise reserves all copyright rights whatsoever. The following statement should apply: copyright 2013 selanox corporation.

Claims

1. A device for collecting a bodily fluid sample from a subject, the device comprising:

at least two sample collection pathways configured to draw the bodily fluid sample into the device from a single end of the device in contact with the subject, thereby separating the fluid sample into two separate samples;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway, whereupon when fluid communication is established, the vessels provide motive force to move a majority of the two separated samples from the pathway into the vessels.

2. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising at least one fluid collection site leading to at least two sample collection pathways configured for drawing a fluid sample therein via a first type of motive force;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway whereupon, when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the pathway into the vessels;

Wherein at least one of the sample collection pathways includes a fill indicator for indicating when a minimum fill level is reached and may engage at least one of the sample vessels to be in fluid communication with at least one of the sample collection pathways.

3. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising at least two sample collection channels configured to draw a fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an internal coating designed to mix with a fluid sample and another of the sample collection channels has another internal coating that is chemically different from the internal coating;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessels;

Wherein the vessels are arranged such that mixing of the fluid sample between the vessels does not occur.

4. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, wherein the sample vessels have a first condition in which the sample vessels are not in fluid communication with the sample collection channel and a second condition in which the sample vessels are operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move the bodily fluid sample from the channel into the vessels.

5. A sample collection device, comprising:

(a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action; and

(b) A sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

wherein the second opening is defined by a portion of the collection channel configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel, and

the sample vessel has an internal volume no greater than ten times an internal volume of the collection channel.

6. A sample collection device, comprising:

(a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action;

(b) a sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) an adapter channel configured to provide a fluid flow path between the collection channel and the sample vessel, having a first opening configured to contact the second opening of the collection channel and a second opening configured to penetrate the cap of the sample vessel.

7. A sample collection device, comprising:

(a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening;

(b) a base comprising a sample vessel for receiving the bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) a support frame is arranged on the base plate,

wherein,

the body and the base are connected to opposite ends of the stand and are configured to be movable relative to each other such that a sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the extended state of the device than in the compressed state,

the second opening of the collection channel is configured to penetrate the cap of the sample vessel,

in the extended state of the device, the second opening of the collection channel is not in contact with the interior of the sample vessel, and

in the compressed state of the device, the second opening of the collection channel extends through the cap of the vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

8. A sample collection device, comprising:

(b) a base comprising a sample vessel for receiving a bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

(c) a stent, and

(d) an adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel and the second opening configured to penetrate the cap of the sample vessel,

wherein the body and the base are connected to opposite ends of the support and are configured to be movable relative to each other such that the sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the expanded state of the device than in the compressed state, in the extended state of the device, the adapter channel is not in contact with one or both of the collection channel and the interior of the sample vessel, and in the compressed state of the device the first opening of the adapter channel 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 vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

9. A device for collecting a fluid sample from a subject, comprising:

(b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

wherein

The second opening of the collection channel is configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel.

10. A device for collecting a fluid sample from a subject, comprising:

(b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) An adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel, and the second opening configured to penetrate the cap of the sample vessel.

11. The device of any one of the preceding claims, wherein the body comprises two collection channels.

12. The device of any one of the preceding claims, wherein the interior of one or more collection channels is coated with an anticoagulant.

13. The device of claim 10, wherein the body comprises a first collection channel and a second collection channel, and an interior of the first collection channel is coated with a different anticoagulant than an interior of the second collection channel.

14. The device of claim 11, wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

15. The device of claim 11, wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate.

16. The device of claim 11, wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin.

17. The device of any preceding claim, wherein the body is formed from a light transmissive material.

18. The device of any one of the preceding claims, wherein the device comprises the same number of sample vessels as collection channels.

19. The device of any of claims 4, 6, or 8-14, wherein the device comprises the same number of adapter channels as collection channels.

20. The device of any one of the preceding claims, wherein the base comprises an optical indicator that provides a visual indication of whether a sample has reached the sample vessel in the base.

21. The apparatus of claim 16, wherein the base is a window that allows a user to view the vessel in the base.

22. The device of any of claims 5, 6, or 9-17, wherein the stand comprises a spring, and the spring exerts a force such that the device is in the extended state when the device is in its natural state.

23. The device of any one of the preceding claims, wherein the second opening of the collection channel or the adapter channel is covered by a sleeve, wherein the sleeve does not prevent movement of bodily fluid from the first opening toward the second opening via capillary action.

24. The device of claim 19, wherein the sleeve includes a vent hole.

25. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 500 uL.

26. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 200 uL.

27. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 100 uL.

28. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 16 mm.

29. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 8 mm.

30. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 4 mm.

31. The device of any one of the preceding claims, wherein the inner perimeter is a circumference.

32. The device of any one of the preceding claims, wherein the device comprises a first collection channel and a second collection channel, and the opening of the first channel is adjacent to the opening of the second channel, and the openings are configured for simultaneously collecting blood from a single drop of blood.

33. The device of claim 28, wherein the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm.

34. The device of any one of the preceding claims, wherein each sample vessel has an internal volume no greater than twenty times greater than the internal volume of the collection channel with which it is engageable.

35. The device of claim 30, wherein each sample vessel has an internal volume no greater than ten times the internal volume of the collection channel with which it is engageable.

36. The device of claim 31, wherein each sample vessel has an internal volume no greater than five times greater than the internal volume of the collection channel with which it is engageable.

37. The device of claim 32, wherein each sample vessel has an internal volume no greater than twice the internal volume of the collection channel with which it is engageable.

38. The device of any one of the preceding claims, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 90% of the bodily fluid sample in the collection channel into the sample vessel.

39. The device of claim 34, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 95% of the bodily fluid sample in the collection channel into the sample vessel.

40. The device of claim 35, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 98% of the bodily fluid sample in the collection channel into the sample vessel.

41. The device of any one of the preceding claims, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in retention of no more than 10uL of bodily fluid sample in the collection channel.

42. The device of any one of claims 37, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in retention of no more than 5uL of bodily fluid sample in the collection channel.

43. The device of any one of claims 39, wherein engagement of the collection channel with the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in no more than 2uL of bodily fluid sample remaining in the collection channel.

44. A method, comprising:

contacting one end of a sample collection device with a bodily fluid sample to separate the sample into at least two portions by drawing the sample into at least two collection channels of the sample collection device via a first type of motive force;

after a desired amount of sample fluid has been confirmed to be in at least one of the collection channels, fluid communication is established between the sample collection channel and the sample vessels, whereupon the vessels provide a second motive force different from the first motive force to move each portion of bodily fluid sample into its respective vessel.

45. A method, comprising:

metering a minimum amount of sample into at least two channels by using a sample collection device having at least two of the sample collection channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force;

after a desired amount of sample fluid has been confirmed to be in the collection channel, fluid communication is established between the sample collection channel and the sample vessel, whereupon the vessel provides a second motive force different from the first motive force to collect the sample to move the bodily fluid sample from the channel into the vessel.

46. A method of collecting a bodily fluid sample, the method comprising:

(a) contacting a bodily fluid sample with a device comprising a collection channel comprising a first opening and a second opening and configured to draw bodily fluid from the first opening toward the second opening via capillary action such that the bodily fluid sample fills the collection channel from the first opening through the second opening;

(b) establishing a fluid flow path between the collection channel and an interior of a sample vessel having an interior volume no greater than ten times an interior volume of the collection channel and having a vacuum prior to establishment of the fluid flow path between the collection channel and the interior of the sample vessel such that establishment of the fluid flow path between the collection channel and the interior of the sample vessel generates a negative pressure at the second opening of the collection channel and transfers a fluid sample from the collection channel to the interior of the sample vessel.

47. A method of collecting a bodily fluid sample, the method comprising:

(a) contacting a bodily fluid sample with the device of any of claims 1-37 such that the bodily fluid sample fills the collection channel from the first opening through the second opening of at least one of the one or more collection channels in the device; and

(b) Establishing a fluid flow path between the collection channel and an interior of the sample vessel such that establishing a fluid flow path between the collection channel and the interior of the sample vessel generates a negative pressure at the second opening of the collection channel, and transferring a fluid sample from the collection channel to the interior of the sample vessel.

48. The method of any one of claims 40-42, wherein the collection channel is not placed in fluid communication with the interior of the sample vessel until bodily fluid reaches the second opening of the collection channel.

49. The method of any one of claims 40-43, wherein the device comprises two collection channels, and the collection channels are not placed in fluid communication with the interior of the sample vessel until bodily fluid reaches the second openings of both collection channels.

50. The method of any one of claims 40-44, wherein the second opening of the collection channel in the device is configured to penetrate the cap of the sample vessel, and wherein a fluid flow path between the second opening of the collection channel and the sample vessel is established by providing relative movement between the second opening of the collection channel and the sample vessel such that the second opening of the collection channel penetrates the cap of the sample vessel.

51. The method of any one of claims 40-45, wherein the device comprises an adapter channel for each collection channel in the device, the adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel, and the second opening configured to penetrate the cap of the sample vessel, and wherein the fluid flow path between the collection channel and the sample vessel is established by providing relative movement between two or more of (a) the second opening of the collection channel, (b) the adapter channel, and (c) the sample vessel such that the second opening of the adapter channel penetrates the cap of the sample vessel.

52. A method for collecting a bodily fluid sample from a subject, the method comprising:

(a) placing a device comprising a first channel and a second channel in fluid communication with a bodily fluid from the subject, each channel having an input opening configured for fluid communication with the bodily fluid, each channel having an output opening downstream of the input opening of each channel, and each channel configured for drawing bodily fluid from the input opening toward the output opening via capillary action;

(b) Fluidly communicating the first and second channels with first and second vessels, respectively, through the output opening of each of the first and second channels; and

(c) directing the bodily fluid within each of the first and second channels to each of the first and second vessels by means of:

(i) a negative pressure in the first vessel or the second vessel relative to ambient pressure, wherein the negative pressure is sufficient to generate a flow of the bodily fluid through the first channel or the second channel into its corresponding vessel, or

(ii) A positive pressure upstream of the first channel or the second channel relative to ambient pressure, wherein the positive pressure is sufficient to generate a flow of the whole blood sample through the first channel or the second channel into its corresponding vessel.

53. A method of manufacturing a sample collection device, the method comprising:

forming a portion of a sample collection device having at least two channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force;

Forming a sample vessel, whereupon the vessel is configured for coupling to the sample collection device to provide a second motive force different from the first motive force to collect a sample to move a bodily fluid sample from the channel into the vessel.

54. Computer-executable instructions for performing a method comprising:

forming part of a sample collection device having at least two channels configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force.

55. Computer-executable instructions for performing a method comprising:

56. A device for collecting a bodily fluid sample from a subject, the device comprising:

means for drawing said bodily fluid sample into said device from a single end of said device in contact with said subject, thereby separating the fluid sample into two separate samples;

Means for transferring a fluid sample into a plurality of sample vessels, wherein the vessels provide a motive force to move a majority of the two separated samples from the pathway to the vessels.

57. A method of performing two or more laboratory tests with a small volume of a liquid sample from a subject, the method comprising:

A) obtaining at a sample collection site at least a first vessel and a second vessel, each of the first vessel and second vessel comprising a portion of a small volume bodily fluid sample from a subject, wherein a total volume of the small volume bodily fluid sample from the subject is no greater than 400 microliters;

B) transporting the first vessel and the second vessel from the sample collection site to a sample receiving site; and

C) performing one or more steps of a first laboratory test with at least a portion of the small volume bodily fluid sample transported in the first vessel and performing one or more steps of a second laboratory test with at least a portion of the small volume bodily fluid sample transported in the second vessel at the sample receiving site.

58. A method of performing two or more laboratory tests with a bodily fluid sample from a subject, the method comprising:

A) Obtaining a plurality of vessels collectively comprising a small volume bodily fluid sample from a subject at a sample collection site, wherein the plurality of vessels comprises at least a first vessel and a second vessel, wherein the first vessel and second vessel each comprise a portion of the small volume bodily fluid sample obtained from the subject, and wherein a total volume of the small volume bodily fluid sample from the subject between all vessels of the plurality of vessels is no greater than 400 microliters;

B) transporting at least the first vessel and the second vessel from the sample collection site to a sample receiving site; and

C) performing a first laboratory test at the sample receiving site with at least a portion of the small volume bodily fluid sample transported in the first vessel, and performing a second laboratory test with at least a portion of the small volume bodily fluid sample transported in the second vessel.

59. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) obtaining at a sample collection site at least a first vessel and a second vessel, each of the first vessel and second vessel comprising a portion of a small volume bodily fluid sample obtained from a subject, wherein a total volume of the small volume bodily fluid sample obtained from the subject is no greater than 400 microliters;

B) Transporting the first vessel and the second vessel from the sample collection site to a sample receiving site;

C) removing a first vessel raw sample from the first vessel at the sample receiving site, wherein the first vessel raw sample is at least a portion of the small volume bodily fluid sample transported in the first vessel;

D) generating a first vessel dilution sample from the first vessel raw sample, wherein the first vessel dilution sample: i) is diluted at least 3 times compared to the first vessel original sample, and ii) has a total volume of no more than 1000 microliters, an

E) Diluting at least a portion of a sample with the first vessel at the sample receiving site performs one or more steps of a first laboratory test, and performing one or more steps of a second laboratory test with at least a portion of the small volume bodily fluid sample transported in the second vessel.

60. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) obtaining a plurality of vessels collectively comprising a small volume bodily fluid sample from a subject at a sample collection site, wherein the plurality of vessels comprises at least a first vessel and a second vessel, wherein the first vessel and second vessel each comprise a portion of the small volume bodily fluid sample obtained from the subject, and wherein a total volume of the small volume bodily fluid sample obtained from the subject between all vessels of the plurality of vessels is no greater than 400 microliters;

B) Transporting at least the first vessel and the second vessel from the sample collection site to a sample receiving site;

C) removing a first vessel raw sample from the first vessel at the sample receiving site, wherein the first vessel raw sample is at least a portion of the small volume bodily fluid sample in the first vessel;

61. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) obtaining a vessel at a sample collection site, the vessel comprising a small volume bodily fluid sample obtained from a subject, wherein the volume of the small volume bodily fluid sample in the vessel is no greater than 400 microliters;

B) Transporting the vessel from the sample collection site to a sample receiving site; and

C) performing one or more steps of a first laboratory test with a first portion of the small volume bodily fluid sample transported in the vessel at the sample receiving site, and performing one or more steps of a second laboratory test with a second portion of the small volume bodily fluid sample transported in the first vessel.

62. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

B) transporting the vessel from the sample collection site to a sample receiving site;

C) removing an original sample from the vessel at the sample receiving site, wherein the original sample is at least a portion of the small volume bodily fluid sample in the vessel;

D) generating at least a first diluted sample and a second diluted sample from the original sample, wherein the first diluted sample: i) at least 2-fold diluted compared to the original sample, and ii) having a total volume of no more than 1000 microliters, and wherein the second diluted sample: i) is diluted at least 5 times compared to the original sample, and ii) has a total volume of no more than 1000 microliters, an

E) Performing one or more steps of a first laboratory test with at least a portion of the first diluted sample and performing one or more steps of a second laboratory test with at least a portion of the second diluted sample at the sample receiving site.

63. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) collecting a small volume bodily fluid sample from a subject into a plurality of vessels, wherein the plurality of vessels comprises at least a first vessel and a second vessel, wherein the first vessel and second vessel each receive a portion of the small volume bodily fluid sample, and wherein a total volume of the small volume bodily fluid sample collected from the subject, including all of the plurality of vessels, is no greater than 400 microliters;

64. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) obtaining one or more vessels containing a small volume bodily fluid sample from a subject at a sample collection site, wherein a total volume of the small volume bodily fluid sample from the subject between all vessels of the one or more vessels is no greater than 400 microliters;

B) transporting the one or more vessels from the sample collection site to a sample receiving site;

C) performing one or more steps of a first laboratory test with a first portion of the small volume bodily fluid sample and performing one or more steps of a second laboratory test with a second portion of the small volume bodily fluid sample at the sample receiving site.

65. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

C) transferring at least a portion of the bodily fluid sample in the first vessel to a first assay unit and transferring at least a portion of the bodily fluid sample in the second vessel to a second assay unit at the sample receiving site, wherein at least one step of a first laboratory test occurs in the first assay unit and at least one step of a second laboratory test occurs in the second assay unit.

66. A method of performing two or more laboratory tests with a small volume liquid sample from a subject, the method comprising:

A) Obtaining at a sample collection site at least a first vessel and a second vessel, each of the first vessel and second vessel comprising a portion of the small volume bodily fluid sample obtained from a subject, wherein a total volume of the small volume bodily fluid sample obtained from the subject is no greater than 400 microliters;

E) Transferring at least a portion of the first vessel diluted sample to a first assay unit and at least a portion of the bodily fluid sample in the second vessel to a second assay unit at the sample receiving site, wherein at least one step of a first laboratory test occurs in the first assay unit and at least one step of a second laboratory test occurs in the second assay unit.

67. The method of any one of the preceding claims, wherein the internal volumes of the first vessel and the second vessel are each 300 microliters or less.

68. The method of any one of the preceding claims, wherein neither the first vessel nor the second vessel comprises a portion of the small volume bodily fluid sample having a volume greater than 250 microliters.

69. The method according to any one of the preceding claims, wherein at least the first vessel contains a bodily fluid sample that fills at least 80% of the internal volume of the vessel.

70. The method of any preceding claim, wherein the sample collection site and the sample receiving site are located in different buildings.

71. The method of any one of the preceding claims, wherein at least the portion of the small volume bodily fluid sample in the first vessel is maintained in liquid form during transport of the first vessel from the sample collection site to the sample receiving site.

72. The method of any of the preceding claims, wherein the first and second vessels are transported from the sample collection site to the sample receiving site in a transport container, wherein the first and second vessels are positioned in an array in the transport container, and wherein the array comprises at least four sample vessels per square inch when viewed from top to bottom.

73. The method of any one of the preceding claims, wherein the transport container comprises bodily fluid samples from at least 3 different subjects.

74. The method of any one of the preceding claims, wherein at least the first vessel comprises an anticoagulant.

75. The method of any one of the preceding claims, wherein the first vessel and the second vessel each comprise an anticoagulant.

76. The method of any one of the preceding claims, wherein the first vessel and the second vessel each comprise an anticoagulant, and wherein the anticoagulant in the first vessel is different than the anticoagulant in the second vessel.

77. The method of any one of the preceding claims, wherein the bodily fluid sample reaches the sample receiving site no more than 24 hours after the bodily fluid sample is obtained from the subject.

78. The method of any one of the preceding claims, wherein the bodily fluid sample is whole blood.

79. The method of any one of the preceding claims, wherein the bodily fluid sample is plasma or serum.

80. The method of any one of the preceding claims, wherein at least the first vessel comprises a separation gel, wherein the gel facilitates separation of whole blood into plasma or serum and a cell layer, the gel settling in the vessel into a layer between the plasma or serum layer and the cell layer.

81. The method of any one of the preceding claims, further comprising centrifuging at least a first vessel containing at least a portion of the small volume bodily fluid sample prior to transporting the first vessel from the sample collection site to the sample receiving site.

82. The method according to any one of the preceding claims, wherein said small volume bodily fluid sample is obtained from a finger/toe of a subject, which finger/toe has been punctured to release a bodily fluid sample from the subject.

83. The method of any one of the preceding claims, further comprising inserting the first vessel into a sample processing device comprising an automated fluid processing device at the sample receiving site and prior to removing a sample from the first vessel.

84. The method according to any one of the preceding claims, wherein the first vessel raw sample is plasma, serum, whole blood, urine, saliva or a nasopharyngeal swab or aspirate.

85. A method comprising collecting capillary blood from a subject, the blood being collected in a plurality of vessels, wherein each vessel does not exceed 150 microliters.

86. A method comprising transporting a fluid sample in liquid form from a first location to a second location.

87. An apparatus includes a shipping container.

88. A device comprising a sample collection device.

89. A system comprising a processor programmed to determine at least a desired sample dilution and at least a desired number of aliquots of a sample.

90. A method comprising at least one technical feature from any one of the preceding claims.

91. A method comprising at least any two technical features from any of the preceding claims.

92. A device comprising at least one technical feature from any of the preceding claims.

93. A device comprising at least any two technical features from any of the preceding claims.

94. A system comprising at least one technical feature from any one of the preceding claims.

95. A system comprising at least any two technical features from any of the preceding claims.