CN109730697A

CN109730697A - For collecting the device of humoral sample

Info

Publication number: CN109730697A
Application number: CN201910039799.8A
Authority: CN
Inventors: E·A·霍姆斯; C·卢; M·陈; D·杨
Original assignee: Serranos Intellectual Property LLC
Current assignee: Serranos Intellectual Property LLC
Priority date: 2012-12-05
Filing date: 2013-12-05
Publication date: 2019-05-10
Also published as: WO2014088606A2; BR112015012944A2; JP2016505302A; MX2015007134A; WO2014088606A8; CA2891513A1; AU2018220026A1; JP2019205911A; SG11201504233RA; CN104968269A; HK1215848A1; KR20150092265A; JP2021178210A; CN104968269B; AU2013356680A1; WO2014088606A3; IL239062A0

Abstract

The present invention relates to the devices for collecting humoral sample.Described device includes: at least two sample collection paths, is configured for for the humoral sample being sucked into described device from the single end for the described device being in contact with the subject, so that fluid sample to be separated into the sample of two separation；Second part, it includes multiple sample vessel for receiving the humoral sample being collected in the sample collection path, the sample vessel can be operatively engaged to be in fluid communication with the sample collection path, then when establishing fluid communication, the vessel provide power so that the major part of described two isolated samples to be moved in the vessel from the access.

Description

For collecting the device of humoral sample

The application is that international filing date is on December 5th, 2013, international application no PCT/US2013/000268, enters National Phase in China application No. is 201380072120.6, it is entitled that " what it is for body fluid sample collection, transport and processing is The divisional application of the application for a patent for invention of system, device and method ".

Background technique

Blood sample for laboratory testing is usually obtained by way of venipuncture, and venipuncture is usual It is related to for hypodermic needle being inserted into the vein of subject.Note can be taken directly by the blood that hypodermic needle is extracted It in emitter, or is drawn into one or more sealed vials, for subsequent processing.When venipuncture be likely difficult to carry out or When unrealistic, such as with newborn, the non-veins such as heel punctures or other alternate sites puncture can be used and wear It pierces to extract blood sample for detection.After being collected into blood sample, usually by the sample packaging being drawn into and it is transferred to Processing center is for analysis.

Regrettably, there are disadvantages with detection technique for the conventional sample collection of humoral sample.For example, in addition to most basic Other than detection, it is currently available that blood testing is usually required that from the considerable volume of blood of subject's withdraw.Due to blood Large volume, it is past to extract blood (can pain less and/or invasive less) from the substitution sampling sites with subject Toward being unfavorable, this is because its not blood volume needed for output common detection methods.In some cases, it is worn with vein Piercing associated patient's worry may be decreased patient compliance to detection scheme.In addition, transporting small samples fluid It may be problematic for still keeping sample integrity simultaneously.

Summary of the invention

At least some or whole embodiments described in present disclosure overcome at least some with prior art phase The shortcomings that association.Although usually describing the reality of this paper under the background for obtaining fluid sample (such as, but not limited to blood sample) Mode is applied, but it is to be understood that, embodiments described herein is not limited to blood sample, and can be adapted to acquire one kind Or various other fluids or one or more body samples are for analysis.

In an embodiment described herein, provide a kind of for collecting the device of humoral sample.Implementing In mode, the body fluid can be blood.In the embodiment for collecting blood, the embodiment is logical for accurately collecting It may be useful for being often associated with the humoral sample of the small size of non-vein blood drawing.In a non-limiting example, described Sample volume is about 1mL or less.Optionally, the sample volume is about 900 uL or less.Optionally, the sample volume About 800uL or less.Optionally, the sample volume is about 700uL or less.Optionally, the sample volume is about 600 uL or less.Optionally, the sample volume is about 500uL or less.Optionally, the sample volume is about 400uL Or it is less.Optionally, the sample volume is about 300 uL or less.Optionally, the sample volume is about 200uL or more It is few.Optionally, the sample volume is about 100uL or less.Optionally, the sample volume is about 90 uL or less.It can Selection of land, the sample volume are about 80uL or less.Optionally, the sample volume is about 70uL or less.Optionally, institute It is about 60uL or less for stating sample volume.Optionally, the sample volume is about 50uL or less.

In a non-limiting example, which can be used for the humoral sample being directly divided into two or more A different piece then stores the part into its corresponding sample vessel.In a non-limiting example, described Device includes first part, and the first part has at least two sample collection channels, and the sample collection channels are matched It sets for fluid sample to be drawn into the sample collection channels via the first type power, wherein the sample collection channels One of have designed for the coated inside that is mixed with fluid sample, and another tool in the sample collection channels There is another coated inside for being chemically different from the coated inside.The sample collection device includes second part, described Second part includes multiple sample vessel for receiving the humoral sample being collected in the sample collection channels, The sample vessel can be operatively engaged to be in fluid communication with the collection channel, then when establishing fluid communication, The vessel, which provide, is different from the second power of first power with by the most of from the channel of the humoral sample It is moved in the sample vessel.The sample vessel can be arranged so that the fluid sample will not occur in the device Mixing between ware.The device can be used for collecting blood or other body fluid.It may be relatively fast from venous collection blood；So And non-vein blood drawing may spend long period of time obtain the sample of intended volume, and anti-coagulants etc. can The early stage of the material of coating channel introduces the too early blocking that can prevent the channel during collection.

In another embodiment described herein, provide a kind of for collecting the device of humoral sample.The device Including first part, the first part includes multiple sample collection channels, wherein at least two in the channel are configured For fluid sample to be drawn into each of described at least two sample collection channels simultaneously via the first type power. Described device may also include second part, and the second part includes being collected in the sample collection channels for receiving The humoral sample multiple sample vessel, wherein the sample device ware has the first situation and the second situation, described the Sample vessel described in one situation are not in fluid communication with the sample collection channels, and the sample described in second situation Vessel can be operatively engaged to be in fluid communication with the collection channel, then when establishing fluid communication, the sample Vessel provide the second power for being different from first power so that humoral sample is moved to the sample vessel from the channel In.In embodiments, the power to mobile body fluid may include from capillarity, reduction pressure (for example, true Empty or partial vacuum is drawn fluid into the position with reduceds pressure), the pressure that increases is with forcing (for example, flowed Body leaves the position with the pressure increased), the power of wick material or other devices.

In further embodiment described herein, provide a method, including by using sample collection Minimal amount of sample is metered at least two channels by device, and the sample collection device has in sample collection channels At least two, the sample collection channels are configured for simultaneously being drawn into fluid sample via the first type power described In each of at least two sample collection channels.The collection channel is in the sample fluid for having been acknowledged desired amount In after, establish and be in fluid communication between the sample collection channels and the sample vessel, then the vessel provide different In the second power of first power to collect sample, humoral sample is moved to the vessel from the channel In.In some alternate embodiments, however not excluded that collect the device of the body fluid using only single channel or have multiple Channel but the device for not being collected simultaneously body fluid.Optionally, the receipts of sample fluid are executed in the case where not using wick material Collection.

In one embodiment, it is deposited between the introducing in sample collection and the sample into sample pretreatment apparatus In the time of discrete magnitude.In a non-limiting example, which is non-continuous process.The sample collection occurs one A treating stations and then the sample is taken to second station.The second station can be in sample construction.Optionally, described Two stations can be located at another place, wherein the sample needs by walking, drives, air transportion, convey, be placed in transport device Or it is placed in shipping container to reach second place.In this way, there is discrete interval, in processes to permit Perhaps the time associated with sample transport.

It can also include one or more separating gels in the sample vessel in another embodiment of this paper, So that the gel will make the cell-free fraction of whole blood and the cellular portions of sample or other solid or semisolid parts Mutually separate.Such gel or other similar separation material can be before introducing sample into the sample vessel, the phases Between or be comprised in the sample vessel later.The separation material can have between the density of cell and solution component it Between density, so as to make the material by during the separation (such as passing through centrifuge separation) flow direction between solution example layer with Position between non-solution example layer, and separate the sample component.After centrifuging, the separation material stops stream It moves and retains as the soft barrier between the layer.In some embodiments, the separation material can be further processed so that It hardens into harder barrier.In a non-limiting example, the separation material can be UV curable material, all The thixotropic gel of gelling agent based on sorbierite such as, but not limited to, in diacrylate ester oligomer.The sample vessel can make whole A vessel optionally make the part with UV curable material be exposed to UV light up to such as, but not limited to the one of 10 to 30 seconds The section time is to harden the material.It is such to harden the crosslinking that can be related to material in UV curable material.Optionally, the UV Curable materials can be used in combination with traditional separating gel material, so that only side (solution side or solid side) and the UV Curing materials are in contact.Optionally, the UV curing materials can be used together with third material, so that the UV solidifies material Material position directly contacts between two kinds of separation materials, and not with the solution of the sample and non-solvent portions.

Humoral sample can be collected by device disclosed and described herein.It is disclosed herein and describes and use these dresses Set the method to collect body fluid.Humoral sample, such as via described device and/or method institute disclosed and described herein The sample of collection can be transported from sample collection place to other one or more places.

In at least one embodiment described herein, provide for by the body fluid of the small size of liquid form From a position physical transportation to the method for another location.For lifting non-limiting example, the sample is being received in liquid form Collect place to collect, transport in liquid form, and reaches analysis place in liquid form.In many embodiments, it transports The liquid form of period and be not kept at porous matrix, wick material, fabric (webbing) or will prevent target place with Liquid form extracts in the similar material of sample.In one embodiment, the sample of the small size in each sample vessel exists In the range of about 1ml to about 500 microlitres.Optionally, small size is in the range of about 500 microlitres to about 250 microlitres.It is optional Ground, small size is in the range of about 250 microlitres to about 100 microlitres.Optionally, small size is at about 100 microlitres to about 50 microlitres In range.Optionally, small size is in the range of about 80 microlitres to about 40 microlitres.Optionally, small size at about 40 microlitres extremely In the range of about 1 microlitre.Optionally, small size is in the range of about 1 microlitre to about 0.3 microlitre.Optionally, small size is about In 0.3 microlitre or less of range.

As disclosed herein with description, shipping container may include the group for being configured for receiving and retaining sample vessel Part.In embodiments, be configured for receiving and retain sample vessel component can be configured for receiving and retaining it is multiple Sample vessel.In embodiments, such component may include plate, such as pallet.In embodiments, such component (for example, plate) may include the opening (for example, slot, hole or receiver) with the inner surface for being configured for receiving sample vessel. In embodiments, shipping container may include the component comprising multiple openings (for example, slot, hole or receiver), the multiple Opening respectively has the inner surface for being configured for receiving sample vessel.In embodiments, such inner surface can be at least It is partly substantially complementary with the outer surface of sample vessel or part of it.

In another embodiment described herein, it is highdensity that the shipping container can provide per unit area Sample vessel, the sample vessel keep in a position-stable manner during transportation but can be removed in target position.It is non-limiting at one In example, the sample vessel position in the form of an array, wherein existing per square inch when observing the array from top to bottom At least six sample vessel.Optionally, when observing the array from top to bottom, there are at least eight samples per square inch Vessel.Optionally, when observing the array from top to bottom, there are at least ten sample vessel per square inch.It transports multiple Any traditional technology of sample is usually using big packet, wherein the sample vessel in big packet are in loose, unconfined form. In some embodiments, the shipping container can accommodate certain sample vessel, such as those samples from same subject Vessel, it is closely close for horizontal or adjacent other intervals sample vessel, so that they can be It is visually identified as from common subject.Optionally, the shipping container has the opening to received vector, institute It states carrier one or more sample vessel keep together, wherein those containers have something in common, and such as, but not limited to come From same subject.

In embodiments, the sample vessel are adapted to assist in keeps the sample in liquid form.In embodiment In, the sample be suitable for keeping in liquid form the sample mode reach sample vessel before, which is carried out Processing.For example, sample vessel may include that anticoagulant or sample can transport to sample vessel or transport sample device Before or during in ware, handled with anticoagulant.In embodiments, anticoagulant can be selected from heparin (for example, liver Plain lithium or heparin sodium), ethylenediamine tetra-acetic acid, 4 hydroxy coumarin, vitamin K antagon (VKA) anti-coagulants, anti-coagulants or its His additive.Other than the high density of per unit area, some embodiments of the shipping container also include high density Sample, the sample including those from multiple and different subjects.For lifting non-limiting example, the shipping container can have There are four samples from a subject, two samples from another subject etc., until in the shipping container It can largely or entirely be filled with opening.

It should be appreciated that each sample can be individually sent to selected analysis, and at least in one embodiment, base It is not grouped in the shipping container in the detection to be executed.For lifting non-limiting example, not shipping container In all sample be collected for same detection.Those can be sent to by traditional detection system merely for the purpose of transport The sample of identical detection is grouped together.In at least one embodiment of this paper, there are various samples, every kind of samples Product are designated to receive the one group of detection of its own.In such an embodiment, the grouping in the shipping container not only limits In the sample that those are directed to same detection.Sample fortune is further separately carried out due to being not needed upon pending detection It is defeated, therefore this can further simplify sample treatment.Some embodiments of the shipping container include to come from least three Or more different patients sample.Some embodiments of the shipping container include to come from least five or more no With the sample of patient.Some embodiments of the shipping container include the sample from least ten or more different patients Product.Some embodiments of the shipping container include the sample from least 20 or more different patients.

For lifting non-limiting example, an embodiment described herein can be optionally using one or more Pallet, the pallet have the slot for accommodating the sample vessel and/or sample vessel holder.In an embodiment In, the pallet while waiting more Multi-example or transport, can also as the storing apparatus being stored in during cooling chamber, In one embodiment, described pallet itself can also be cleaned and be sterilized, because in some embodiments, the support Disk can be removed from the shipping container.In some embodiments, the pallet in the shipping container can be by flat Mode of the row in the covering of the shipping container is kept.Optionally, the pallet can be with the institute of the shipping container Covering is stated angularly to be maintained inside the shipping container.Optionally, the pallet is fixed on the transport non-removablely Container.Optionally, the pallet and the shipping container itself are integrally formed.Optionally, there is identical or different size or match The multiple pallets set can be placed in the inside of the shipping container.

In another embodiment described herein, provide for transporting small samples using shipping container The method of vessel, the shipping container, which has, provides actively and/or passively cooling integrated thermal control unit and/or material. In one embodiment, it is embedded phase change material (PCM), the material that the heat management material, which may be, but not limited to, Material keeps the temperature at previous or desired temperature.For lifting non-limiting example, the phase-change material can fight and surround The temperature change of critical-temperature, at the critical-temperature, the material can undergo phase transformation.If being embedded in the PCM, institute State vessel and passive cooling element can be it is same.Optionally, Active Cooling System can be used in the shipping container.It can Active Cooling System can be used to keep and/or extend associated with passive cooling component cold in selection of land, the shipping container But the time.In embodiments, shipping container may include with high heat capacity (that is, compared to such as plastics or polymerization material The materials such as material, with high heat capacity) material, and may include a large amount of such high heat capacity material, which is prolonging At least part of the shipping container is effectively kept in the long period at or approximately at desired temperature.

Optionally, the method includes for will multiple sample vessel from different subjects from temperature control memory block turn Move on to the single step in shipping container.For lifting non-limiting example, which can simultaneously by 24 or more Multiple sample vessel are transferred to the fixation position in the shipping container from storage location.Optionally, which can be with 36 or more sample vessel are transferred to the fixation position in the shipping container from storage location simultaneously.It is optional 48 or more sample vessel can be transferred to the shipping container from storage location simultaneously by ground, the single step In fixation position.In such an embodiment, the pallet initially can be in control thermal environment, and the control thermal environment is all Such as, but not limited to, refrigerating box, wherein the sample from each subject is collected over time, until reaching desired number Mesh.In such embodiment, the pallet of one or more of sample vessel is accommodated in the shipping container It is the same pallet that the sample vessel are accommodated in the memory block.Optionally, the pallet can be with storage holder Identical, the storage holder before loading sample to the shipping container for accommodating the sample.Because described in accommodating The same pallet of sample vessel will use in the shipping container, so losing sample during the transfer, in non-regulated The risk that sample etc. is omitted in thermal environment reduces.Since in single step, essentially all of sample vessel in the pallet Accumulation in the hot memory block of the control and is then transferred, so the sample controls hot memory block and be transferred to institute from described Substantially the same heat exposure is undergone while stating in shipping container.Because sample vessel experienced substantially the same sudden and violent Dew, so the changeability between sample and sample is reduced due to different exposure durations.

Optionally, the method includes using separately addressable sample vessel to configure.Optionally, point of sample vessel Group can address such as those of in common carrier in predefined grouping.Sample optionally or even in common carrier Vessel, which can be, individually to be addressed.Although this is not requirement to all embodiments herein, this is from the pallet It is particularly useful when loading and/or unloading sample, sample vessel and/or sample retainer.

Some embodiments can be used the another container (" outer container (outerbox) ") outside the shipping container with Further physical protection and/or thermal control ability are provided.One or more of described shipping container can be placed on described Within outer container, and the combination can be transported to destination locations from a position.For lifting non-limiting example, this can be with It is the form of corrugation plastic outer container, wherein the outer container is configured at least partly encase or surround shipping container.Implementing In mode, outer container provides thermal insulation for the shipping container wherein surrounded.Closed pore extruded polystyrene can be used in some embodiments Vinyl foam outer container.Some embodiments of the outer container can be formed by thermoforming plate.In some embodiments, outer container Can have handle, handle, liner, wheel, latch, pull rod and/or for keeping, manipulating, fasten, protect, transport or with other Mode controls other features of the position of the content of the outer container, orientation and/or entrance.Some embodiment party of the outer container Formula can have the actively and/or passively thermal control units of its own.In embodiments, outer container is wherein surrounded one Or multiple shipping containers provide cooling and thermal insulation.One or more embodiments of the outer container can be configured for accommodating One or more shipping containers.Optionally, which can also be provided by one or more shipping containers thereto in the phase Thermal conditioning environment between the temperature range of prestige provides additional thermal control to the shipping container.Optionally, the temperature Range is between about 1 DEG C to 10 DEG C, optionally between 2 DEG C to 8 DEG C or between 2 DEG C to 6 DEG C.

In another embodiment described herein, provide a kind of for the thermal characterization after several cooling cycles The method of shipping container.For lifting non-limiting example, after the circulation of certain amount, it can be held with being transported described in thermal characterization Device is to ensure that container continuation executes operation in expected range.

Some embodiments of the container and/or pallet may include thermal change indicator.Non-limiting show at one In example, the indicator is integrated on the visible surface of the shipping container, pallet, and/or is integrated in the outer container On.In a non-limiting example, thermochromatic inks may be used as the indicator of thermal change, especially if the heat Variation causes temperature except expected range.In one embodiment, the indicator can be configured for making entire case and/ Or pallet discoloration.The variation can be reversible or irreversible.Optionally, the indicator is only positioned at the transport and holds In the selected part of device and/or pallet, rather than on whole container or pallet.

It in an embodiment described herein, provides a method, this method is included in subject interface's receipts Collect humoral sample, wherein collected sample is stored in one or more sample vessel；Shipping container is provided, first Receiving at least two or more sample vessel in orientation；And it is arranged so that the sample vessel hold in the transport Be transported to the second position from first position in device, wherein each sample vessel reach the second position and accommodate its is non-wicking, The major part of the humoral sample of non-matrix form, the humoral sample can be pipetted from the sample vessel in liquid form, and And wherein in each sample vessel sample amount no more than about 2ml.In embodiments, sample in each sample vessel Measure 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 it is less.

In another embodiment described herein, a kind of method for transporting multiple sample vessel, institute are provided The method of stating includes: offer container, which is configured for receiving at least five or more and respectively contains capillary blood Sample vessel；And it is arranged so that the sample vessel are transported to second from first position in the shipping container Position, wherein each sample vessel reach the second position and accommodate the capillary blood of its liquid, non-wicking form Most of, which can pipette for further processing from the sample vessel, and wherein each sample device The amount of capillary blood in ware no more than about 2ml.In embodiments, the capillary blood in each sample vessel Amount 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, provide a kind of multiple to contain biological sample for transporting Sample vessel method, which comprises provide container, which is configured for accommodating in the sample device ware At least five or more, wherein the amount no more than about 2ml of the sample in each sample vessel；And by the container and sample Product vessel are transported to the second position from first position, wherein each sample vessel reach the second position and accommodate its liquid, non-core The major part of the biological sample of suction form, the biological sample can pipette for further processing from the sample vessel.? In embodiment, the amount no more than about 1ml of the sample in each sample vessel, 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, provide a kind of multiple comprising capillary blood for transporting Sample vessel method, which comprises provide have thermal conditioning interior zone container, be configured for accommodating At least five or more sample vessel are in controlled configuration, so that at least one cooling surface of the container is towards institute It states sample vessel and transmits the cooling control release of heat according to temperature curve, the temperature curve is kept during transportation The interior zone is at about 1 to 10 DEG C without freezing the blood sample；And the container is transported to from first position Two positions, wherein each sample vessel reach and accommodate its liquid, non-wicking form capillary blood in major part, The capillary blood can pipette for further processing from the sample vessel.

In another embodiment described herein, provide a kind of for transporting the side of multiple blood sample vessel Method is configured for 10 or more that receiving is in array configuration the method includes transporting the container having inside thermal control A sample vessel, wherein each vessel accommodate the major part in the blood sample of its free-flowing, non-wicking form, and Wherein there is about 1ml or less blood in each vessel, and each vessel have with the interior of at least partly vacuum atmosphere Portion；Wherein sample vessel are kept with array configuration so that the sample vessel are located in away from cooling surface controlled distance and orientation Place, wherein there are at least one from the surface to the preferential heat passage of the sample vessel.

In another embodiment described herein, provide a kind of for transporting multiple sample vessel lower than 1ml Method, the method includes mixing sample with anti-coagulants before sample to be transferred to each sample vessel；By each sample Product vessel are associated with the sample detection of subject and one group of requirement；And thermal control container is transported, thermal control container receiving In the multiple sample vessel lower than 1ml of array configuration, wherein each vessel accommodate its free-flowing, non-wicking shape Major part in the sample of formula, wherein vessel be arranged such that in each container there are at least two vessel with it is each tested Person is associated, and wherein at least the first sample includes the first anti-coagulants and the second sample includes the second anti-coagulants in matrix.

It in another embodiment described herein, provides a method, which comprises a) will be described more A sample vessel are placed in temperature control shipping container, and the temperature control shipping container includes being configured to and the sample The controlled uniform heat distribution of product vessel thermal communication, high fever integrating materials (fusion material), wherein the material is not Lead to freezing for the sample fluid in the sample vessel；B) the heat distribution shipping container is placed on by shipping container At least in product chamber defined by roof and bottom wall；C) by active cooling device be placed as with the chamber thermal communication, it is thus described Cooling device is suitable for the cooling chamber in activation, and the absorption cooling device includes absorber, which is oriented So that the heat generated in the absorber is dissipated in outside the product chamber；D) activate the cooling device described to start The cooling of chamber；E) shipping container is transported from first position to the second position；And the production f) is removed from the chamber Object.

In another embodiment described herein, a kind of side for transporting multiple sample vessel lower than 1ml is provided Method, which comprises transport thermal control container, thermal control container receiving is in the multiple sample lower than 1ml of array configuration Vessel, wherein each vessel accommodate the major part in the sample of its free-flowing, non-wicking form, and wherein vessel quilt It is associated with each subject to be arranged so that in each container that there are at least two vessel, wherein at least the first sample includes First anti-coagulants and the second sample includes the second anti-coagulants in matrix.

It should be appreciated that any embodiment of this paper may be adapted to one or more of following characteristics.At one In non-limiting example, the humoral sample is blood.Optionally, the humoral sample is capillary blood.Optionally, Collecting the humoral sample includes being punctured at least once to discharge body fluid to the subject, wherein the puncture is not Venipuncture.Optionally, collection includes being punctured at least once using at least one micropin to the subject.It is optional Ground, collection include being punctured at least once using at least one lancet to the subject.Optionally, pass through finger It stabs to form the puncture.Optionally, the puncture is formed by stabbing the skin on subject's forearm.It is optional Ground forms the puncture by stabbing the skin on subject's limbs.Optionally, the surface is the subject Skin.Optionally, the shipping container has inside, and the inside is initially at sub-atmospheric pressures.Optionally, described sub- big Air pressure is at least partial vacuum.Optionally, at sub-atmospheric pressures, the sub-atmospheric pressure is at least low for the inside of the shipping container Under the pressure of environmental stress.Optionally, the sub-atmospheric pressure is selected to provide enough power for the sample of intended volume and inhale Enter into the sample vessel.Optionally, the shipping container includes at least five or more sample vessel.Optionally, The shipping container transports the humoral sample from multiple and different subjects.Optionally, letter associated with each sample vessel Which detection breath determination will carry out to humoral sample therein.Optionally, the shipping container is placed in separately during transport In one container.Optionally, the method also includes before being transported to the second position to the sample in the sample vessel It is pre-processed.

Optionally, the shipping container has the sample vessel array density of at least about 4 vessel per square inch.It can Selection of land, the cooling surface in the shipping container provide in the expected range for the sample vessel in the vessel Temperature curve.Optionally, the sample vessel are separately addressable.Optionally, the method also includes by the device Ware accommodates the sample vessel in cooling chamber using cooling pallet before loading into the container, and is come using same pallet The sample vessel in the vessel are accommodated, wherein the sample is placed in a reservoir with the cooling pallet.Optionally, Arrange sample vessel so that in each container exist at least two have the humoral sample from same subject vessel, Wherein at least the first sample includes the first anti-coagulants and the second sample includes the second anti-coagulants in matrix.Optionally, described Fluid sample includes capillary blood, with for being permitted by FDA or FDA certification measurement device and program carry out Detection, or the detection carried out by CLIA accredited laboratory.Optionally, the fluid sample includes blood, for leading to The detection that FDA license or FDA certification measurement device and program carry out is crossed, or carried out by CLIA accredited laboratory Detection.Optionally, the shell for providing the integrating materials of controlled heat distribution and high fever provides at least one towards the vessel Cooling surface.Optionally, the integrating materials of high fever are embedded in the material for being used to form the vessel.Optionally, controlled heat point Cloth, high fever integrating materials account for about 30% to 50%.Optionally, controlled heat distribution, high fever integrating materials account for about 10% to 30%.Optionally, the method also includes the shell of metal material, which has the static temperature lower than environment temperature (resting temperature)。

Optionally, the method also includes scan the information memory cell on each sample locating for the received field and Automatically the vessel are placed in a casket, optionally, the method also includes scanning each sample locating for the received field On information memory cell and automatically the vessel are placed in a casket, optionally, the method also includes working as sample When product vessel are in refrigerating plant before transportation and are in the shipping container during transportation, same support is used The sample vessel are contained in the array configuration by disk.Optionally, the method also includes using pallet for accommodating packet Sample vessel containing highly heat-conductive material.Optionally, the pallet includes multiple slots, and the slot has to protect sample vessel Holder is maintained at the shape of preferred direction.Optionally, the pallet is configured for direct joined sample vessel holder.It can Selection of land, tray locking mechanism is for being maintained at the pallet in the vessel, wherein the tray locking mechanism is only applying The pallet is discharged when magnetic force.Optionally, the method includes maintaining the temperature at 2 DEG C to 8 DEG C of range during transportation.It can Selection of land, the method also includes temperature-control materials, which is maintained at chill point or more during transportation, and is about 10 DEG C Or it is lower.Optionally, the method includes using temperature threshold to detect detector, to indicate whether the sample vessel reach Temperature except threshold level.Optionally, the method also includes: scan the vessel in the pallet, before shipment with true It is fixed whether processing step have been performed to the sample；It is executed or is re-execute the steps using processor.Optionally, described Method further includes the single step loaded one or more of sample vessel into the pallet and fills the pallet The single step being loaded onto the shipping container.

Optionally, the shipping container has a first surface, the first surface be configured for limiting thermal conducting path to The integrating materials of controlled heat distribution, high fever in the shipping container.Optionally, the first surface be configured to by inhaling The cooling another surface of attached cooling device directly contacts.Optionally, the method includes simultaneously to the sample in the pallet Vessel carry out bar code scanning.Optionally, the method includes carrying out item to the bottom surface of the sample vessel in the pallet simultaneously Shape code scanning.Optionally, the method includes carrying out bar code scanning to sample vessel ranks.Optionally, the method includes Bar code scanning is carried out to the bottom surface of sample vessel ranks.Optionally, the method includes reversely transporting multiple sample vessel. Optionally, the method includes transporting multiple sample vessel, wherein haemocyte and blood plasma are by the barrier material in the sample vessel Material separates.Optionally, the method includes the container, wherein at least one are opened by unlocking and opening shipping container Articulation piece keeps together two components.Optionally, the pallet has at least one magnetic contact point, is used for the support Disk is removed from the vessel.Optionally, computer control end effector be used for from the shipping container load and/or Unload sample vessel, wherein before, during or after unloading, reader from be attached to one or more sample vessel to Information is obtained in a few information memory cell.It will be appreciated that though the shipping container is commonly used in transport, but work as the fortune When defeated container is not used in transport, it is also used as the storage container of the pallet and/or sample vessel.Therefore, the appearance The purposes of device is not limited to transport, and is not excluded for other suitable purposes for any embodiment.

In the another embodiment of this paper, provide it is a kind of for transporting the thermal control shipping container of multiple sample vessel, The shipping container includes: the container at least with the common roof for limiting chamber, bottom wall and side wall, wherein the roof, bottom wall It include phase-change material at least one of side wall；Frame, the frame be sized to be matched with it is described intracavitary, and should Frame limits the opening for being configured for accommodating multiple sample vessel and has the side wall being configured to the sample vessel The side wall being in contact, wherein arrangement vessel are so that each patient at least has the first sample and tool comprising the first anti-coagulants There is the second sample of the second anti-coagulants in matrix.

In another embodiment described herein, a kind of thermal control fortune for transporting multiple sample vessel is provided Defeated container, the shipping container include: a) bottom container part comprising the bottom wall and at least the first side wall of chamber are limited, it is described Chamber is suitable for wherein including product；B) top container part comprising top surface and ground and be suitable in conjunction with the bottom hold To limit product chamber, the top container part forms the roof for being directed to the vessel for device part；The wherein roof, bottom wall It include phase-change material at least one of side wall.

In another embodiment described herein, a kind of thermal control fortune for transporting multiple sample vessel is provided Defeated container, the shipping container include: a) bottom container part comprising the bottom wall and at least the first side wall of chamber are limited, it is described Chamber is suitable for wherein including product；B) top container part comprising top and bottom and be suitable for and the bottom container Part is combined to limit product chamber, and the top container part forms the roof of the vessel；C) retainer is used to limit The sample vessel to be located on predetermined direction by multiple sample vessel accommodation spaces；The wherein roof, bottom wall and side wall At least one of include phase-change material.

In another embodiment described herein, provide a kind of for transporting the shipping container of sample vessel, institute Stating container includes: generally rectangular bottom plate；Usually from the parallel side that the longitudinal edge of the bottom plate protrudes；Usually For the parallel end that the side is protruded and bridged from the end margin of the bottom plate；Covering can be matched with the side Usually closed space is formed on face and end and with the side and end and with the bottom plate；Sample vessel are kept Device, the bottom plate being removably coupled in the container inside and be configured for limit vessel accommodation space.It is optional Ground, the vessel accommodation space are configured for accommodating vacuum blood collecting tube, and the blood collection tube is with about 2ml or more Small internal capacity.In at least one embodiment, the vessel accommodation space is configured for accommodating vessel, the vessel Such as, but not limited to vacuum collecting pipe, the collecting pipe with about 1ml or less than about 500 μ L or less than about 250 μ L or are less than About 100 μ L are less than about 50 μ L or smaller internal capacity.

In another embodiment described herein, a kind of thermal control fortune for transporting multiple sample vessel is provided Defeated container, the shipping container include: for making multiple sample vessel be maintained at the device at least one fixed-direction；With The temperature of sample vessel described in thermal control makes its device within about 0 DEG C of expected range to 10 DEG C；Wherein for holding The device of the multiple sample vessel received can be removed from the shipping container.Optionally, the vessel accommodation space It is configured for accommodating vacuum blood collecting tube, the blood collection tube has about 2ml or smaller internal capacity.Implementing In mode, the vessel accommodation space is configured for accommodating vacuum collecting pipe, which has about 1ml or be less than about 500 μ L are less than about 250 μ L or are less than about 100 μ L or are less than about 50 μ L or smaller internal capacity.

It should be appreciated that some embodiments may include kit, which includes such as institute in any of above embodiment The shipping container of elaboration.Optionally, the kit includes shipping container and the explanation that uses about it.

In an embodiment described herein, describe it is a kind of for by whole blood sample and/or its part from hair The method that the person of sending is supplied to recipient.The method includes transporting the packaging including sample vessel, until at least working as whole blood sample And/or when the arrival recipient of its part, the sample vessel include one or more channels, which includes that (a) has There are the whole blood sample and/or its part and (b) one or more use of the fluidised form of less than or equal to about 200 microlitres (ul) volumes It is described in the reagent for saving one or more analytes in the whole blood sample and/or its part for analyzing, and wherein Storage causes the sample vessel to be delivered to the recipient.For lifting non-limiting example, transporting the sample device ware can To be occurred by using package delivery service, express delivery or other pick-up services.

In an embodiment described herein, describe a kind of for preparing whole blood sample for being delivered to sample The method of product treating stations, the method includes storing the whole blood sample with fluidised form using delivery service and be less than or wait In the sample vessel of about 200ul volume, the delivery service for the sample vessel are delivered to be used to handle it is described complete The sample treatment position of blood sample.The sample vessel can extract institute from subject by means of capillary channel by (a) It states whole blood sample and (b) whole blood sample is placed in the sample vessel and is prepared, wherein the whole blood sample It is protected with being included in together with one of the capillary channel and/or the sample vessel or plurality of reagents with fluidised form It deposits.

It should be appreciated that any embodiment of this paper may be adapted to one or more of following characteristics.Lift non-limit For property example processed, the sample in some embodiments can be semisolid or gel state.This can occur at the sample After in the sample vessel.Optionally, the delivery service is postal delivery services.Optionally, the blood sample It is collected from the subject at point-of care position.Optionally, the point-of care position is the family of the subject.Optionally, institute State the position that point-of care position is health care provider.

In another embodiment described herein, the method for handling whole blood sample is included in treating stations from packet It wraps up in delivery service and receives sample vessel, the sample vessel have the whole blood sample less than or equal to about 200ul, wherein described Sample vessel are received in the treating stations and the whole blood sample with fluidised form；And in the treating stations to the complete of the fluidised form Blood sample carries out at least one preanalysis measurement and/or analysis measurement.

It should be appreciated that any embodiment of this paper may be adapted to one or more of following characteristics.Lift non-limit For property example processed, the measurement has one or more steps.Optionally, the sample vessel be included in one or In the shell in multiple environmental Kuznets Curves areas.Optionally, the shell is suitable for controlling the humidity in each environmental Kuznets Curves area.Optionally, The shell is suitable for controlling the pressure in each environmental Kuznets Curves area.

In another embodiment described herein, provide it is a kind of for blood sample be lined up for The computer implemented method that processing position is handled.The method includes (a) by means of the geography with computer processor Positioning system identifies the geographical location of the shipping container with blood or other humoral samples；(b) by means of computer disposal Device come estimate the shipping container to it is described processing position Delivery time；And it (c) is mentioned based on estimated Delivery time For being directed to the notice of preparation, for handling the sample in the processing position.

In another embodiment described herein, describe a kind of for preparing whole blood sample for being delivered to sample The method of product treating stations, the method includes the sample vessel of the whole blood sample with fluidised form, institute are stored using delivery service It states delivery service to be used to for the sample vessel to be delivered to the sample treatment position for being used to handle the whole blood sample, wherein institute It states sample vessel and the whole blood sample is extracted from subject by (a) use device and (b) is placed on the whole blood sample It is prepared in the sample vessel.

Optionally, storage may include picking up and/or putting down for sample vessel.Optionally, processing may include pre- point of sample Analysis processing, analysis processing and post analysis processing.Optionally, delivery service may include that the delivery service of subject or third party pass Take business.Optionally, the whole blood sample be included in one of the capillary channel or the sample vessel or more Kind reagent is saved together with fluidised form.

In another embodiment described herein, provide a kind of in the side for the treatment of stations processing whole blood sample Method.The method includes receiving the sample vessel with whole blood sample from delivery service in the treating stations, wherein the sample Vessel extract the whole blood sample from subject using collection device by (a) and the whole blood sample (b) are placed on institute It states in sample vessel and is prepared.It is at least one the method also includes being carried out in the treating stations to the whole blood sample Preanalysis measurement or analysis measurement.

It should be appreciated that any embodiment of this paper may be adapted to one or more of following characteristics.Lift non-limit For property example processed, by means of computer processor provided by estimated Delivery time for complete the processing when Between.Optionally, after the method includes being the Delivery time of sample vessel described in the processing location estimation, to the sample Product vessel be lined up for processing.Optionally, the geographical location of the sample vessel is identified by means of communication network.

In an embodiment described herein, describe a kind of for providing for handling estimating for blood sample Count the computer implemented method of deadline.The method includes receiving to be transported to treating stations about by delivery service The information of the shipping container of (being used for sample treatment), the shipping container have the blood sample taken out from subject.Institute The method of stating further includes calculating position of the blood sample in processing queue in the treating stations by means of computer processor Set, wherein it is described prediction based on (i) about from the blood of other subjects or other humoral samples in the processing queue Position information, and (ii) about with the sample vessel (have pipetted from the subject blood sample) phase The information in the geographical location of other sample vessel (with the blood sample from other subjects) closed.The method includes Prediction is after being delivered to the treating stations by delivery service for the sample vessel, in the treating stations processing blood The time of liquid sample；And based on it is described prediction and it is estimated by the sample vessel be delivered to the treating stations when Between, it provides for the subject or health care provider relevant to the subject for handling from the subject Blood sample the estimation time, it is described estimation the time from stored with the delivery service sample vessel time point survey Amount.Optionally, the sample is transported to multiple treating stations.It should be appreciated that processing as used herein should be solved broadly It releases and may include one or more preanalysis, analysis and/or post analysis step.

In another embodiment described herein, describe a kind of for providing for handling from subject's The computer implemented method of the estimated time to completion of blood sample.The method includes receive about by delivery service by Transport the information of the shipping container to treating stations (be used for sample treatment), the shipping container have at least one from it is described by The blood or humoral sample pipetted in examination person.The method also includes being calculated in the treating stations by means of computer processor Position of the blood sample in processing queue, wherein the prediction is based on (i) about the blood sample from other subjects The information of position of the product in the processing queue, and (ii) (have from the subject about with the shipping container In the blood sample that pipettes) relevant other sample vessel (with the blood sample from other subjects) geographical location Information.The method includes predicting after the shipping container is delivered to the treating stations by delivery service, it is used for The treating stations handle the time of the blood sample；And the shipping container is delivered with estimated based on the prediction To the time of the treating stations, one or more resources are distributed in the treating stations, for being delivered to by the blood sample The treating stations post-process the blood sample.

It should be appreciated that any embodiment of this paper may be adapted to one or more of following characteristics.Lift non-limit For property example processed, the shipping container has information memory cell, which allows by the delivery service And/or the processing position identifies the shipping container.Optionally, the information memory cell is radio frequency identification (RFID) Label.Optionally, the information memory cell is bar code.Optionally, the information memory cell is microchip.Optionally, The shipping container includes one or more temperature for collecting the humoral sample (for example, blood sample), the sample The pressure of product vessel, the pH of the sample, the turbidity of the sample, the viscosity of the sample or the sample other are special The sensor of one or more of property.Optionally, the processing position handles collected humoral sample according to demand.It can Selection of land, the shipping container include the geographic locating device for being used to provide the described the position of sample vessel.Optionally, described anti- Coagulator is selected from heparin, ethylenediamine tetra-acetic acid, anti-coagulants or other additives.Optionally, the shipping container is (wherein described Container accommodation space is configured for accommodating vacuum blood collecting tube) it is configured for accommodating evacuated sample collection pipe, the sample Product collecting pipe has most about 30% vacuum or most about 40% vacuum or most about 50% vacuum or most about 60% very Empty or most about 70% vacuum or the most about partial vacuum of 80% vacuum or most about 90% vacuum.

It is described herein, be related in the embodiment of the first vessel and the second vessel, in some embodiments, The internal capacity of first vessel and the second vessel be respectively 1000 microlitres, 750 microlitres, 500 microlitres, 400 microlitres, it is 300 micro- Rise, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, it is 40 micro- It rises, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 microlitres, 5 microlitres, 4 microlitres, 3 Microlitre, 2 microlitres or less.It is described herein, be related in the embodiment of the first vessel and the second vessel, in certain realities Apply in mode, the internal capacity of first vessel and the second vessel be no more than 1000 microlitres, 750 microlitres, 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, it is 60 micro- Rise, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, it is 6 micro- It rises, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres.It is described herein, be related in the embodiment of one or more vessel, In certain embodiments, the internal capacity of each of one or more of vessel is 1000 microlitres, 750 microlitres, 500 Microlitre, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 Microlitre, 5 microlitres, 4 microlitres, 3 microlitres, 2 microlitres or less.It is described herein, be related to the embodiment party of one or more vessel In formula, in some embodiments, the internal capacity of one or more of vessel be no more than 1000 microlitres, 750 microlitres, 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, it is 70 micro- Rise, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, it is 7 micro- It rises, 6 microlitres, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres.

It is described herein, be related in the embodiment of the first vessel and the second vessel, each vessel include small size A part in humoral sample, in some embodiments, first vessel and the second vessel do not include to have and be greater than 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, it is 70 micro- Rise, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, it is 7 micro- It rises, 6 microlitres, 5 microlitres, 4 microlitres, a part of the small size humoral sample of the volumes of 3 microlitres or 2 microlitres.

It is described herein, be related to comprising small size humoral sample vessel embodiment in, in certain embodiment party In formula, the volume of the small size humoral sample in the vessel no more than 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 Microlitre, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 microlitres, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres.

Described herein, it is related in the embodiment of one or more vessel comprising humoral sample, in certain realities Apply in mode, at least one of one or more of vessel include fill the vessel internal capacity at least 99%, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10% or 5% humoral sample.Described herein, it is related in the embodiment of one or more vessel comprising humoral sample, In certain embodiments, all vessel in one or more of vessel include the internal capacity for filling the vessel At least 99%, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10% or 5% humoral sample.

It is described herein, be related in the embodiment in sample collection place and sample reception place, in embodiment In, the sample collection place and sample reception place can be in identical room, building, garden or buildings.? It is described herein, be related in the embodiment in sample collection place and sample reception place, in embodiments, the sample Product collection location and sample reception place can be in different rooms, building, garden or buildings.In embodiment In, sample collection place and sample reception place can be separated by least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1,000 Rice, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms or 500 kms.In embodiments, sample Product collection location and sample reception place can be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 km, 5,000 Rice, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms, 500 kms or 1000 kms.In embodiment In, sample collection place and sample reception place can be separated by least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1,000 Rice, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms or 500 kms, and it is no more than 5 meters, 10 Rice, 50 meters, 100 meters, 500 meters, 1 km, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms, 500 kms or 1000 kms.In embodiments, first position described herein can be sample collection place, and herein The described second position can be sample reception place.

In embodiment that is described herein, being related to vessel, the vessel include from sample collection place transport to At least part in the small size humoral sample in sample reception place, in embodiments, the humoral sample is in the device Liquid form can be remained during the transport of ware.In embodiment party described herein, being related to two or more vessel In formula, each vessel include at least one transported from sample collection place into the small size humoral sample in sample reception place Part, in embodiments, the humoral sample in each vessel can remain liquid during the transport of the vessel Form.

It is described herein, be related to being transported from sample collection place to one or more vessel in sample reception place Embodiment in, in embodiments, one or more of vessel can transport in a transport container.It is retouched in this paper It is stating, be related in the embodiment of the one or more vessel transported in a transport container, it is in embodiments, one Or multiple vessel can be located in the form of an array in the shipping container, and when observing from top to bottom, the array is every Square inch may include at least one, 2,3,4,5,6,7,8,9,10,15,20,25, 30,35,40,50 or 100 vessel.

It is described herein, be related in the embodiment for transporting one or more vessel in a transport container, implementing In mode, the shipping container may include from least one, 2,3,4,5,6,7,8,9,10,15 A, 20,25,30,35,40, the humoral sample of the different subjects of 50 or 100.

It is described herein, be related to comprising humoral sample at least part of vessel embodiment in, implementing In mode, the vessel may include anti-coagulants.The humoral sample from subject is respectively contained being related to two or more In the embodiment of the vessel of a part, in embodiments, at least one or all vessel may include anti-coagulants.Implementing In mode, when the vessel of a part that two or more respectively contain the humoral sample from subject also each include anti- When solidifying agent, the vessel may include identical anti-coagulants or different anti-coagulants.Anti-coagulants in vessel can be such as heparin Or EDTA.

It is described herein, be related to by the humoral sample in one or more vessel from sample collection place transport to In the method in sample reception place, in embodiments, the humoral sample can obtain the body fluid from the subject Be no more than after sample 48 hours, 36 hours, 24 hours, 16 hours, 12 hours, 8 hours, 7 hours, 6 hours, 5 hours, it is 4 small When, reach the sample within 3 hours, 2 hours, 60 minutes, 45 minutes, 30 minutes, 20 minutes, 15 minutes, 10 minutes or 5 minutes Reception site.

It is described herein, be related to from sample collection place transporting at least one vessel to sample reception place In method, in embodiments, the method is centrifuged it before may additionally include the transport vessel.In this paper institute Description, be related to from sample collection place transporting multiple vessel into the method in sample reception place, in embodiments, The method is centrifuged it before may additionally include the multiple vessel of transport.

It is described herein, be related to from sample collection place transporting at least the first vessel to sample reception place In method, in embodiments, in the sample reception place and before pipetting sample in first vessel, incite somebody to action First vessel are inserted into the sample processing device comprising automation fluid treating device.It is described herein, be related to At least the first vessel and the second vessel are transported from sample collection place into the method in sample reception place, in embodiment In, in the sample reception place and before pipetting sample in first vessel, by first vessel and second Vessel are inserted into the sample processing device comprising automation fluid treating device.In embodiments, with sample when wrapping Vessel be inserted into including automate fluid treating device sample processing device in when, sample can be by the automation fluid at Reason device is pipetted from the vessel.In embodiments, will wrap vessel with sample be inserted into including automation fluid at Before managing in the sample processing device of device, the vessel are inserted into a casket, and the cylinder casket is then inserted into institute It states in sample processing device.Cylinder casket can accommodate any number of, packet vessel with sample, such as at least one, 2,3,4 A, 5,6,7,8,9,10,15,20,25,50 or 100 vessel.Cylinder casket also may include being used for One or more reagents of one or more laboratory testings are executed to the sample.In embodiments, cylinder casket may include holding It is about to all reagents necessary to all detections executed with one or more samples in the cylinder casket.

In embodiments, a part of the part of the humoral sample in vessel can be any amount.For example, implementing In mode, a part of the part of the humoral sample in the first vessel can be a part or of the first vessel primary sample A part of one vessel dilute sample.In another example, in embodiments, the part of the humoral sample in the second vessel A part can be a part of the second vessel primary sample or a part of the second vessel dilute sample.

It is provided herein, be related in the embodiment for transporting one or more vessel, each vessel include from sample receive Collect place to sample reception place at least partly humoral sample, in embodiments, can to described in the vessel extremely A part in small part humoral sample executes one or more steps in any number of laboratory testing.For example, In embodiment, can in at least partly humoral sample a part execute 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 kind or more different laboratory One or more steps in detection.Individual a part of the humoral sample can be used in a variety of different laboratory testings, Or in embodiments, more than one different laboratory testing can be executed with the specific part of the humoral sample.Institute Stating different laboratory testings can be same type, different types of or same type and different types of mixed It closes.One or more of vessel can be, for example, the first vessel or the first vessel and second phase ware.

In embodiments, when the humoral sample from subject transported according to system provided herein or method When for more than one laboratory testing, every kind of laboratory testing can be used it is each detection be no more than 50,40,30,25,20, 15, the pure humoral sample of 10,9,8,7,6,5,4,3,2,1,0.5,0.1,0.05 or 0.01 equivalent is (for example, undiluted complete Blood, saliva or urine).

It is provided herein, be related in the embodiment that sample collection place obtains multiple vessel, the multiple vessel The small size humoral sample from subject is jointly comprised, in embodiments, between whole vessel of the multiple vessel , the total volume of the small size humoral sample obtained from the subject can no more than 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 microlitres, 5 microlitres, it is 4 micro- It rises, 3 microlitres or 2 microlitres.

It is provided herein, be related to transport from sample collection place to sample comprising the vessel of at least partly humoral sample In the embodiment of product reception site, primary sample is pipetted from the vessel in the sample reception place, and then from this Primary sample generates dilute sample, and in embodiments, the dilution can step by step or be continuously generated.In embodiment party In formula, the dilute sample can have no more than 1000 microlitres, 900 microlitres, 800 microlitres, 700 microlitres, 600 microlitres, it is 500 micro- It rises, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 Microlitre, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, it is 6 micro- It rises, 5 microlitres, 4 microlitres, the total volumes of 3 microlitres or 2 microlitres.In embodiments, the dilute sample can be relative to the original Beginning sample dilute at least 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 15 times, 20 times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times or 100,000 times.

It is provided herein, be related to from sample collection place transporting at least the first vessel and the second vessel to sample and connect End embodiment in, first vessel and the second vessel respectively contain the small size body obtained from the subject A part of liquid sample, in embodiments, in the sample reception place, the first vessel primary sample can be from described It is pipetted in one vessel and the second vessel primary sample can be pipetted from second vessel.First vessel dilute sample can be with It is generated from the first vessel primary sample.Second vessel dilute sample can be generated from the second vessel primary sample.Institute State the volume and dilution that the first vessel dilute sample and the second vessel dilute sample can be having the same or different.Implementing In mode, multiple and different dilute samples can be from one of the first vessel primary sample or the second vessel primary sample Or all the two generates.The different dilute sample can be used for one or more different laboratory testings, the laboratory Detection can be different type.In embodiments, the first vessel dilute sample can be relative to the first vessel primary sample Dilute at least 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 15 times, 20 times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times or 100,000 times, and have and be no more than 1000 microlitres, 900 microlitres, 800 microlitres, 700 microlitres, 600 microlitres, 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 Microlitre, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 microlitres, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres Total volume, and the second vessel dilute sample can dilute at least 2 times, 3 times, 4 relative to the second vessel primary sample Times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 15 times, 20 times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times or 100,000 times, and have no more than 1000 microlitres, 900 microlitres, 800 microlitres, 700 microlitres, 600 microlitres, 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 Microlitre, 90 microlitres, 80 microlitres, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, 8 microlitres, 7 microlitres, 6 microlitres, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres of total volume.

It is provided herein, be related to sample collection place obtain vessel embodiment in, the vessel include from by The small size humoral sample that examination person obtains, in embodiments, the volume of the small size humoral sample in the vessel can With no more than 500 microlitres, 400 microlitres, 300 microlitres, 250 microlitres, 200 microlitres, 150 microlitres, 100 microlitres, 90 microlitres, it is 80 micro- Rise, 70 microlitres, 60 microlitres, 50 microlitres, 40 microlitres, 30 microlitres, 25 microlitres, 20 microlitres, 15 microlitres, 10 microlitres, 9 microlitres, it is 8 micro- It rises, 7 microlitres, 6 microlitres, 5 microlitres, 4 microlitres, 3 microlitres or 2 microlitres.

It is provided herein, be related to obtaining vessel and by the vessel from the sample collection place in sample collection place Transport is into the embodiment in sample reception place, and the vessel include the small size humoral sample obtained from subject, in reality It applies in mode, the small size humoral sample may be logically divided into any number of part, such as 2,3,4,5,6,7 A, 8,9,10,15,20,25,30,40,50,60,70,80,90,100,200 A, 300,400,500 or 1000 different parts.The part can be diluted into same or different amount, And can 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 kind or more different laboratory testing.

It is provided herein, be related to obtaining in sample collection place comprising in the small size humoral sample from subject At least one at least part of vessel embodiment in, in embodiments, the acquisition step may include from described Subject's (for example, from fingerstick or vein haemospasia) collects the small size humoral sample.

It is provided herein, be related in determination unit execute laboratory testing at least part of embodiment in, In embodiments, the determination unit can be moveable, such as mobile by fluid treating device.It is including two Or more in the embodiment of determination unit, in embodiments, the determination unit can be can be movable independently.

In the embodiment of transport that is provided herein, being related to one or more vessel comprising humoral sample, one In a little embodiments, the vessel can have any of vessel described herein or other vessel suitable for storing body fluid Characteristic.In some embodiments, the vessel can be by any device or method provided herein, or by for filling Carrier has other suitable technologies of the vessel of small internal capacity to load humoral sample.For example, in certain embodiments In, the vessel to be transported according to system provided herein or method can load sample by syringe or pipette tip.

Optionally, at least one embodiment of the sample collection device of this paper can separate single blood sample to not In same vessel, for different preanalysis processing.This can be by fluid passage in described device and/or logical The different ingress ports crossed in described device are realized.

The content of present invention is provided to introduce the concept picked out in simplified form, the concept is in embodiment party in detail below It is further described in formula.The content of present invention is not intended to determine the key feature or main feature of claimed theme, also not It is intended for limiting the range of claimed theme.

It quotes and is incorporated to

All publications, patents and patent applications mentioned in this specification are incorporated by reference into this, degree Like specifically and individually pointing out to be incorporated by reference into each individual publication, patent or patent application.

Detailed description of the invention

Figure 1A-Figure 1B shows the perspective view of the sample collection device according to an embodiment as described herein.

Fig. 2A-Fig. 2 C shows according to an embodiment as described herein, not cap sample collection device Perspective view.

Fig. 3 A- Fig. 3 B shows the side view of the sample collection device according to an embodiment as described herein And cross-sectional view.

Fig. 4 A- Fig. 4 B shows the side view of the sample collection device according to an embodiment as described herein And cross-sectional view.

Fig. 5 A- Fig. 5 B shows the perspective view of the sample collection device according to another embodiment as described herein.

Fig. 6 A- Fig. 6 B shows the side view of the sample collection device according to an embodiment as described herein.

Fig. 7 A- Fig. 8 B shows the side view of the sample collection device according to an embodiment as described herein And cross-sectional view.

Fig. 9 A- Fig. 9 C shows sample according to an embodiment as described herein, in each service stage The sectional view of product collection device.

Figure 10 A- Figure 10 B shows the perspective of the sample collection device according to an embodiment as described herein Figure.

Figure 11 A- Figure 11 Z shows each example of the sample collection device according to embodiment as described herein View.

Figure 12 is shown and an embodiment as described herein is associated, tip portion of sleeve and related The schematic diagram of the balance of the power of connection.

Figure 13 A- Figure 13 D shows according to embodiment as described herein, with collection position upwardly The view of each collection device.

Figure 14-Figure 15 shows receipts according to an embodiment as described herein, with single collection position Each view of acquisition means.

Figure 16-Figure 17 shows according to an embodiment as described herein, use the vessel with marker Sample collection device perspective view and end-view.

Figure 18 A- Figure 18 G shows each view of the sample vessel according to embodiment as described herein.

Figure 19 A- Figure 19 C shows the view of each embodiment of the front end of sample collection device.

Figure 20-Figure 21 shows each embodiment of the sample collection device with Integrated Tissue penetrating component.

Figure 22 show it is according to embodiments described herein, be used for and blood vessel or other tissue penetrators And the perspective view of collection device that sample divider is used together.

Figure 23-Figure 28 show it is according to embodiments described herein, for making together with various sample dividers Each view of collection device.

Figure 29 A- Figure 29 C shows the schematic diagram of each embodiment as described herein.

Figure 30-Figure 31 shows the schematic diagram of the method according to embodiments described herein.

Figure 32 shows the schematic diagram of an embodiment of system as described herein.

Figure 33 to Figure 37 shows the another embodiment of collection device described herein.

Figure 38 A- Figure 39 is shown to be transported according to the thermal control shipping container of at least one embodiment described herein Each view of device.

Figure 40 A- Figure 40 C shows the schematic diagram of various embodiments described.

Figure 41 show it is according at least one embodiment described herein, wherein have multiple sample vessel Shipping container a part perspective view.

Figure 42 is according at least one embodiment described herein, wherein with the fortune of multiple sample vessel The decomposition perspective view of one part of defeated container.

Figure 43 shows the perspective view of the shipping container according to another embodiment described herein.

Figure 44 shows the sample collection according to an embodiment described herein and transports the schematic diagram of process.

Figure 45 shows the sample collection according to another embodiment described herein and transports the schematic diagram of process.

Figure 46 shows the sample collection device according to an embodiment described herein.

Figure 47 show it is according to an embodiment described herein, for from shipping container unload sample vessel A system schematic diagram.

Figure 48 is curve graph, and it illustrates the stability of the analyte in the sample in vessel provided in this article.

Figure 49 to Figure 51 shows non-limiting according to one of the detection of at least one embodiment described herein Example.

Figure 52 to Figure 55 shows each view of the device and system according to embodiments herein.

Figure 56 to Figure 59 shows each view according to the sample transport device of at least some embodiments herein.

Specific embodiment

It should be appreciated that above be broadly described and the following detailed description be all only exemplary with it is explanatory, and And the claimed invention is not construed as limiting.It is noted that as made in this specification and the appended claims With, singular "one", "an" and "the" etc. include plural reference, unless the context clearly determines otherwise.Cause This for example mentions the mixture that " a kind of material " may include multiple material, it may include a variety of for mentioning " a kind of compound " Compound etc..References cited herein is incorporated by and quoting hereby in this, unless they reach and this explanation The conflicting degree of the introduction being expressly recited in book.

In the present specification and in subsequent claims, it will mention several terms, these terms should be determined Justice is to have following meanings:

" optional " or " optionally " mean that the event then described may occur or may not occur, so that this is retouched It states and includes the case where that the event does not occur there is a situation where the event and.For example, if device optionally includes to receive for sample Collect the feature in hole, it means that the specimen collection well there may be or may be not present, and therefore, which wraps simultaneously Wherein device is included to have the structure of the specimen collection well and the structure of the specimen collection well is wherein not present.

Term as used herein " substantially " means more than the smallest or inapparent amount；And " essentially " Mean more than minimally or indistinctively.Therefore, for example, phrase used herein is " substantially different " indicates two Sufficiently high difference degree between a numerical value, so that those skilled in the art would consider that the difference between the two values exists There is statistical significance in the background of the characteristic as measured by described value.Therefore, as a reference value or the function of fiducial value, two A difference being substantially different between mutual value is generally greater than about 10%, and can be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, preferably greater than about 50%.

" sample " used herein can be but not limited to a part of blood sample or blood sample, can be and appoint What suitably sized or volume, and preferably small size or volume.In some implementations of measurement and method disclosed herein In mode, small size blood sample can be used or measure no more than the small volume fraction of blood sample, wherein Small size includes no more than about 5mL；Or including no more than about 3mL；Or including no more than about 2mL；Or including being no more than About 1mL；Or including no more than about 500 μ L；Or including no more than about 250 μ L；Or including no more than about 100 μ L；Or Person includes no more than about 75 μ L；Or including no more than about 50 μ L；Or including no more than about 35 μ L；Or including being no more than About 25 μ L；Or including no more than about 20 μ L；Or including no more than about 15 μ L；Or including no more than about 10 μ L；Or packet Include no more than about 8 μ L；Or including no more than about 6 μ L；Or including no more than about 5 μ L；Or including no more than about 4 μ L； Or including no more than about 3 μ L；Or including no more than about 2 μ L；Or including no more than about 1 μ L；Or including no more than about 0.8μL；Or including no more than about 0.5 μ L；Or including no more than about 0.3 μ L；Or including no more than about 0.2 μ L；Or Person includes no more than about 0.1 μ L；Or including no more than about 0.05 μ L；Or including no more than about 0.01 μ L.

Term as used herein " service point position " may include that subject can receive service (for example, inspection wherein Survey, monitoring, treatment, diagnosis, guidance, sample collection, ID verifying, medical services, non-medical service etc.) position, and can be with Including but not limited to the residence of subject, the workplace of subject, health care provider (for example, doctor) position, Hospital, emergency ward, operating room, clinic, the office of health care professionals, laboratory, retailer's [such as pharmacy (example Such as, retail pharmacy, clinical pharmacy, hospital pharmacy), pharmacy, supermarket, grocery store etc.], the vehicles (for example, car, vessel, Truck, bus, aircraft, motorcycle, ambulance, mobile unit, fire fighting truck/fire engine, emergency vehicles, enforcement vehicle, police Vehicle is configured for for subject being transported to other carriers etc. of another point from a point), mobile medical treatment health care unit, Mobile unit, school, day-care center, safety check place, operation place, medical treatment auxiliary life residence, government bodies, office building, Tent, humoral sample collecting location (for example, blood collection center), subject may want to the place entered inlet or Place, subject near it may want to access device at or near it place (for example, the position of computer --- If subject desires access to computer), sample processing device receive the position of sample, or other are described everywhere herein Any other service point position.

" body fluid " used herein can be any fluid that is obtaining from subject or can obtaining from subject. Body fluid for example can be blood, urine, saliva, tear, sweat, the body secretes obtained derived from subject's or from subject Object, body excretions or any other fluid.Specifically, body fluid includes but is not limited to blood, serum, blood plasma, marrow, saliva Liquid, urine, gastric juice, spinal fluid, tear, excrement, mucus, sweat, earwax, oil, glandular secretion object, cerebrospinal fluid, sperm, vaginal secretion, source In the tissue fluid of tumor tissues, ocular fluids, tire liquid, amniotic fluid, Cord blood, lymph, chamber liquid, sputum, purulence, meconium, breast milk And/or other secretion or excreta.

" body fluid sample collection device " used herein or any other collecting mechanism can be disposably.For example, body Collection can be used primary and abandon.Humoral collector can have one or more disposable assemblies.Alternatively, body fluid Collector can be reusable.Arbitrary number of times may be reused in humoral collector.In some cases, body fluid is received Storage had not only included reusable component but also had included disposable assembly.

Any other part of " sample collection unit " and/or device used herein can receive unitary class The sample of type or a plurality of types of samples.For example, sample collection unit can receive two distinct types of body fluid (example Such as, blood, tear).In another example, sample collection unit can receive two distinct types of biological sample (for example, urine sample, fecal specimens).A plurality of types of samples may or may not be that fluid, solid and/or half are solid Body.For example, sample collection unit can receive one of body fluid, secretion and/or tissue sample or it is a variety of, two kinds Or more or it is three or more.

" non-wicking, non-matrix form " used herein mean liquid or suspension not by fabric, mesh, fiber mat, Absorbing material, absorbing structure, percolating network of fiber etc. are absorbed or are pulled in wherein, and the fabric, fiber mat, absorbs material at mesh Material, absorbing structure, fiber percolating network change the form of liquid or suspension or catch the component of sample and sink into wherein to reach So far forth, so that the integrality of the sample of liquid form is changed and can not be the case where still keeping sample integrity Under extract sample in liquid form for sample analysis.

Term as used herein " sample processing system " refer to be configured for help sample imaging, detection, positioning, It relocates, retain, the device or system of intake and storage.In one example, the robot with liquid relief ability is sample Processing system.In another example, can have or can not have the pipettor of (other) robot capability is sample Processing system.It may or may not include fluid by the sample that sample processing system is handled.Sample processing system can be with Body fluid, secretion or tissue can be transported.Sample processing system can be able to need not be one kind of sample in conveyer Or many kinds of substance.For example, can transport can be with the powder of one or more example reactions for sample processing system.Some In the case of, sample processing system is fluid handling system.Fluid handling system may include various types of pumps and valve or shifting Liquid device, the pipettor can include but is not limited to positive displacement pipettor, exhaust pipettor and assimilating type pipettor.Sample Processing system can transport sample or other substances by means of other robots described everywhere herein.

Term as used herein " health care provider " is directed to subject's offer therapeutic treatment and/or medicine is built The doctor of view or other health care professionals.Health care professionals may include associated with medical health system Personnel or entity.The example of health care professionals may include doctor (including general practitioner and specialist), outer Section doctor, dentist, audiologist, speech pathologist, physician extenders, nurse, midwife, pharmacist/pharmacists, nutrition Teacher, therapist, shrink, masseur, clinical medical official, Physical Therapist, blood drawing teacher, occupational therapist, optist, emergency medical services Technician, paramedical personnel, medical laboratory technician, medical prosthetic technician, radiographer, social worker and trained offer Other numerous human resources of some type of Health Care Services.Health care professionals may have qualification or may No qualification is prescribed.Health care professionals may operate in or be under the jurisdiction of hospital, health care place and other services Point is provided, or academic training, research and management organization can also be worked in.Some health care professionals can be in private Nursing and treatment service are provided in people or public place, community center or gathering place or mobile unit for patient.Community is protected Strong worker can be in the local work other than formal medical health institution.Health Care Services manager, medical records with Health and fitness information technical staff and other support staff are also possible to health care professionals or are under the jurisdiction of health care offer Person.Health care professionals, which can be, provides preventative, therapeutic, publicity property or rehabilitation doctor for personal, family or community Treat individual or the mechanism of health care service.

In some embodiments, health care professionals may already be familiar with subject or with subject into Went communication.Subject may be the patient of health care professionals.In some cases, health care professionals can Subject can have been required to follow the doctor's advice and carried out clinical detection.Health care professionals may have indicated that or suggest subject It is subjected to the clinical detection carried out at service shop position or by laboratory.In one example, health care professionals can be with It is the primary care doctor of subject.Health care professionals can be any kind of doctor (including the general practice of subject Doctor, the medical practitioner that changes the place of examination (referred practitioners), or alternately through Telemedicine selection and The doctor and/or specialist of the patient of connection oneself).Health care professionals can be medical treatment and nursing professional people Member.

Term as used herein " rack " refers to the frame or shell for installing multiple modules.Rack is configured to use In allowing for module to be fastened to the rack or be engaged with the rack.In some cases, each size of rack is standardization 's.In one example, the separation criteria between module turns at least about 0.5 inch or 1 inch or 2 inches or 3 English Very little 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 English Very little multiple.

Used term " cell " includes size sample generally similar with individual cells under biological sample background Product, including but not limited to vesica (liposome), cell, virion and small with globule, nano particle or microballoon etc. The substance that particle combines.Characteristic includes but is not limited to size；Shape；Cell is mobile or time changes such as proliferation and dynamic State variation；Granularity；Whether cell membrane is complete；Internal cell inclusion, including but not limited to protein content, protein are repaired Decorations, nucleic acid content, nucleic acid modification, organelle content, nuclear structure, core content, internal eucaryotic cell structure, internal compartment The presence of other small molecules of content, ion concentration and such as steroids or drug etc；And cell surface is (thin After birth and cell wall) marker, including protein, lipid, carbohydrate and its modification.

" sample " used herein refers to entire primary sample or its any part, unless the context otherwise specifically It is bright.

The present invention provides the system and method for the multipurpose analysis for sample or health parameters.Sample can be collected, And one or more sample preparation steps, determination step and/or detecting step can be carried out on device.It is described herein Various aspects of the invention are applicable to any specific application, system and device set forth below.The present invention can be used as independence System or method apply, or applies as a part of integrated system, such as applied to being related to service point health care System among.In some embodiments, system may include the imaging technique (such as ultrasonic wave or MRI) of exterior orientation, Or it is integrated with for integrated form imaging and other health detections or the peripheral equipment of service.It should be appreciated that the present invention Different aspect can understand and practice individually, jointly or in conjunction with each other.

With reference to Figure 1A-Figure 1B, an embodiment of sample collection device 100 will now be described.In the non-limiting example In, sample collection device 100 may include collection device main body 120, bracket 130 and pedestal 140.In some cases, optionally Cap 110 can be provided.In one embodiment, the cap can be used for protecting opening, keep its cleaning, and be used for The tip of masking tape blood after collection.Optionally or alternatively, the cap can also be used in sample fluid into sample vessel During transfer, by controlling the discharge amount for being provided to capillary come limited flow rate.Some embodiments may include the discharge in cap Hole access (permanent to open wide or operationally close), and other embodiments then do not include the discharge orifice access.It can Selection of land, collection device main body 120 may include that there are one or more accesses of collecting (such as, but not limited to collect logical wherein Road 122a, 122b) device 100 first part, which can receive sample B.Figure 1A shows sample B Only partially it is filled with channel 122a, 122b, it should be appreciated that although being not excluded for part in some alternate embodiments Filling, but in most cases, when the filling process is finished, the channel will be filled up completely by sample B.At this In embodiment, pedestal 140 can have one or more pad indicator 142a, 142b, and such as, but not limited to optics indicates Device, the indicator can provide the instruction that the one or more vessel being contained in pedestal whether are had arrived to sample.It answers Work as understanding, although the instruction can be by way of visually indicating, other indicating means such as audio, vibration also can be used Dynamic or other indicating means, to substitute the indicating means or in combination.The indicator can be located in the vessel On at least one.For embodiments described herein, there may be variations and substitution, and should not be by any single reality The mode of applying is construed to comprising entire invention.

Although bracket 130 may also comprise the such filling instruction of one or more for ease of explanation without showing Device: the pad indicator shows whether have reached desired fill level in channel 122a and 122b.This can substitute or It is additional to pad indicator 142a, 142b.Certainly, one or more of access pad indicators can be positioned at different On component, and it is not limited on bracket 130.It will be appreciated that though in one or more channels in channel 122a and 122b Such fill level instruction can be by way of visually indicating, but also can be used other indicating means such as audio, Vibration or other indicating means, to substitute the indicating means or in combination.The indicator can be located at described collect and lead to On at least one of road.Optionally, indicator is located on all collection accesses.

In the present embodiment, bracket 130 can be used for being coupled main body 120 and pedestal 140 to form integrated form device.It answers Work as understanding, although apparatus main body 120, bracket 130 and pedestal 140 are described as isolated component, one in these components Or multiple may be integrally formed manufactures so as to simplified, and is not excluded for herein such integrated.

In some embodiments of this paper, cap 110 can be optionally provided.In a non-limiting example, described Cap can cooperate in a part of collection device main body 120.Cap 110 can be can be from the disassembly of collection device main body 120. In some cases, cap 110 can be and can be kept completely separate from collection device main body 120, or can retain a part even It is connected to collection device main body, it is such as, but not limited to hinged or be otherwise linked to collection device.Cap 110 can be covered on A part of the collection device main body 120 of exposed ends wherein comprising one or more channels.When cap is in place, cap 110 can be with Prevent the materials such as air, fluid or particle from entering the channel in apparatus main body.Optionally, ability can be used in cap 110 Any known or technology researched and developed from now in domain and be attached to and collect main body 120.For example, the cap can be clasped, be screwed on In, frictional fit, clamping in, have magnetic part, be to, can connect using elastic part and/or removedly To collection device main body.Cap can form fluid-tight sealing with collection device main body.Cap can be by opaque, transparent or semi-transparent Bright material is formed.

In one embodiment, the collection device main body 120 of sample collection device may include such as, but not limited to channel One or more at least part for collecting access such as 122a, 122b are in wherein.It should be understood that, however not excluded that it is not the receipts in channel Collect access.Collection device main body can connect to may include a part in one or more channels in bracket 130 therein.It receives Acquisition means main body can be permanently affixed to bracket, or can be relative to the bracket can be removed.In some cases, it collects Apparatus main body and bracket can be formed by single single piece.Alternatively, collection device main body and bracket can be formed by separation member.It is filling During the operation set, collection device and bracket are not moved relative to each other.

Optionally, collection device main body 120 can be formed entirely or partly by light transmitting material.For example, collection device master Body can be formed by transparent or semitransparent material.Optionally, only the selected part of main body be it is transparent or semitransparent so that one The visualization of a or multiple fluid collections channel.Optionally, main body includes opaque material, but opening can be formed in main body And/or window shows fill level therein.Collection device main body can enable a user to observe in the apparatus main body And/or channel 122a, 122b across the apparatus main body.The channel can be formed by transparent or semitransparent material, be allowed User checks whether sample B has already passed through the channel.The channel can have basically the same length.In some cases Under, bracket 130 can be formed by opaque material, transparent material or trnaslucent materials.Bracket can have or can not have Optical characteristics identical with collection device main body.Bracket can be formed by the material different from collection device main body, or by with The identical material of collection device main body is formed.

Collection device main body 120 can have any shape or size.In some instances, collection device main body can have Circle, ellipse, triangle, quadrangle (for example, square, rectangle, trapezoidal), pentagon, hexagon, octagon or any Other cross-sectional shapes.Along the length of collection device main body, the cross-sectional shape can keep identical or can become Change.In some cases, collection device main 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.Along collection device master The length of body 120, cross-sectional area can change or can keep identical.Collection device main body can have less than or equal to about The length of 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.5cm or 0.1cm. Collection device main body 120 can have than cap, bracket or the greater or lesser length of pedestal, or equal with cap, bracket or pedestal Length.For embodiments described herein, there may be variations and substitution, and should not be by any single implementation Mode is construed to comprising entire invention.

In one embodiment, such as, but not limited to channel 122a, 122b etc., which collects access, can also have selected cross Cross sectional shape.Some embodiments in channel can cross-sectional shape having the same along the overall length in the channel.Optionally, edge The length, cross-sectional shape can keep identical or can change.For example, some embodiments can be along channel Length a position at have a kind of shape, and at one or more different locations have different shapes.Some realities The mode of applying can have at least one other logical of the channel and varying cross-section shape for possessing a cross-sectional shape Road.For lifting non-limiting example, some embodiments can have circle, ellipse, triangle, quadrangle (for example, just It is rectangular, rectangle, trapezoidal), pentagon, hexagon, octagon or any other cross-sectional shape.For main body, bracket and base Seat, cross-sectional shape can be identical or can change.Some embodiments can choose shape so that for specific Channel width and/or height, the liquid volume that can be contained in channel maximize.Some embodiments can make channel 122a, One of 122b has a kind of cross-sectional shape, and another channel is made to have different cross-sectional shapes.In an embodiment In, the cross-sectional shape in channel can help to maximize volume therein, but optionally, it can also optimize to blood Capillary pulling power.This will allow maximized fill rate.It should be appreciated that in some embodiments, the cross section shape in channel Shape can directly affect capillary force.For lifting non-limiting example, the sample of certain volume can be included in shallow and wide lead to In road or circular channel, both contain identical volume, but lower possibility for filling speed, air entrapment or For factor relevant to channel performance, a kind of channel may be more more preferable than another channel.

Although channel can have any shape or a size, some embodiments be configured so that channel with sample Capillarity is shown when fluid is in contact.In some cases, channel can have 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.Edge Length, cross section size can keep identical or can change.Some embodiments can be in order to along a certain length Biggish power and the then lesser power in another length and customize.Along length, cross-sectional shape can keep phase Together or it can change.Some channels are straight in configuration.Some embodiments can individually or with straight part There is curved or other shapes path shape with being combined.Some embodiments can have difference in apparatus main body 120 Orientation.For example, one or more channels are at it from the initial collection point band on device when device keeps substantial horizontal It when walking fluid, can tilt down, tilt or do not tilt upwards.

Channel 122a, 122b can be supported by apparatus main body 120 and/or bracket 130.In some cases, channel is complete Length can be comprised within the combination of apparatus main body and bracket.In some cases, a part in channel can be located at apparatus main body Within, and a part in channel can be located within bracket.The position in channel can be fixed by apparatus main body and/or bracket. In some embodiments, channel can be defined as the inner cavity in hollow needle.In some embodiments, only in the three side upper limits Routing, at least side are unlimited.Optionally, otherwise the coating separated with main body, which can limit, will be unlimited one Side.Some embodiments can limit the not ipsilateral of channel with different materials.These materials can be provided all by main body, Or they can be provided by the different parts of collection device.Some embodiments can have all in same plane Channel.Optionally, some embodiments can have the shape that at least part in channel is brought to Different Plane and/or orientation Shape.Optionally, some channels can be completely in Different Plane and/or orientation.

In some cases, multiple channels can be provided.In some embodiments, a channel is divided into two or more Multiple channels.Optionally, some channels are divided into even larger number of channels.Some channels may include control mechanism, such as but It is not limited to use in the valve for guiding the flowing in one or more channels.At least part in channel can be substantially parallel to each other. Alternatively, any part in channel all do not need it is parallel to each other.In some cases, at least part in channel is not parallel to each other. Optionally, channel can slight curvature.Optionally, channel can have a cross-sectional area at a position, and along this There is smaller cross-sectional area at the different location in channel.Optionally, channel can be transversal with one at a position Area, and there is bigger cross-sectional area at the different location along the channel.For Y shape design some embodiments, It may be desirable to channel will have it is appropriate place to limit the discharge orifice of sample for each bottle, thus there is no from The sample or cross contamination that other channels pull out.For lifting non-limiting example, one with discharge orifice is shown in Figure 11 I A embodiment.

Pedestal 140 can be provided in sample collection device.The pedestal can be connected to bracket 130.In some cases, A part of pedestal, which can be, to be inserted into bracket and/or a part of bracket can be and be inserted into pedestal 's.Pedestal can be moved relative to bracket.In some cases, sample collection device can have along the sample collection The longitudinal axis that the length of device extends.Pedestal and/or bracket can move on the direction of the longitudinal axis relative to each other.Pedestal and/ Or bracket can be moved relative to each other limited distance.Alternatively, pedestal can be fixed relative to bracket.Pedestal can provide At one end opposite with including one end of sample collection device of cap 110, sample collection device.Optionally, Yi Xieshi The mode of applying may include integrated form pedestal/vessel part, to no longer there is the isolated vessel being assembled in base part. For embodiments described herein, there may be variations and substitution, and should not explain any single embodiment For comprising entirely inventing.

Pedestal 140 can accommodate one or more vessel wherein.The vessel can with passage, and/or It can be taken to and passage.The one end in channel can be located in vessel, or can be taken in vessel.Pedestal can have One or more optical indicator 142a, 142b, the optical indicator can be provided and be received to whether sample has arrived at The one or more vessel being dissolved in pedestal visually indicate.In some embodiments, optical indicator, which can be, may make User can view the optical window in pedestal.The optical window can be formed by transparent and/or trnaslucent materials.Alternatively, light Learning window can be in the wherein not no opening of any material.Optical window can enable a user to directly observe in pedestal Vessel.Vessel in pedestal can be formed by transparent and/or trnaslucent materials, can enable a user to check that sample is The no vessel for having arrived at pedestal.For example, vessel can be indicated visually if blood is transported to vessel along channel Blood is in presence wherein.In other embodiments, optical indicator may include its that can indicate that vessel have been filled His feature.For example, can provide one or more sensors in pedestal or vessel, the sensor be may determine whether Through providing the sample of sufficient amount in vessel.One or more of sensors can optical indicator on pedestal provide Signal, the signal may indicate whether the sample size for providing sample to vessel and/or providing to vessel.For example, Optical sensor may include display, such as, but not limited to LCD display, optical display unit (for example, light-emitting diode display), plasma Panel type display can provide the instruction being fully filled to vessel.In the alternative, without providing optics Indicator, but can provide the indicator of substitution such as, but not limited to can serve to indicate that vessel in when being filled Audio indicator or temperature control indicator.

Fig. 2A-Fig. 2 C provides the view of the sample collection device 200 of no cap 110.Sample collection device 200 can wrap Include main body 220, bracket 230 and pedestal 240.Main body can be connected to bracket.In the present embodiment, pedestal 240 can with connection Bracket is connected at one end opposite to one end of main body.Main body is sustainable and/or includes one, two or more channel At least part of 222a, 222b.Channel can receive sample 224a, 224b from the sample reception end 226 of device.

Main body 220 can have hollow parts 225 wherein.Alternatively, main body can be formed by solid member.Channel 222a, 222b It may be integrally formed into main body.For example, they can be the access of the solid section across main body.The access can be drilled through Or it is formed using photoetching technique.Alternatively, can be can be by the isolated structure of body supports in channel.For example, channel can By that can be formed by one or more pipes of body supports.In some cases, channel can be in certain solid sections of main body Place is held in place, and may pass through one or more hollow parts of main body.Optionally, main body 220 can be by being bound up Two parts are formed, to limit channel 222a and 222b therein.

Channel 222a, 222b may include other one or more features or characteristic for mentioning everywhere herein.Channel is at least A part can be substantially parallel to each other.Alternatively, channel can be at an angle relative to each other.In some embodiments, channel can have There is first end, which can be located at the sample reception end 226 of sample collection device.The first end in channel can be can Receive the open end of sample.In some embodiments, it can be provided at the sample reception end of sample receiving device each logical The end in road.One, two or more channel can have the first end at the sample reception end of sample collection device.It can With use separation channel so that the blood cross contamination between a channel and another channel risk minimization.It is optional Ground, channel can have the configuration of falling Y shape, and wherein channel originates in public passage and is divided into the channel of two or more separation. In the case where pollution is not a problem, such Y shape configuration can be useful.Optionally, the alternative approach of Y shape configuration will It can be straight channel, and keep sample collection vessel mobile to engage the same needle from straight channel in order.

In some cases, multiple channels can be provided.The end in the channel at sample reception end can closely be leaned on each other Closely.It the end in the channel at sample reception end can be adjacent to each other.The end in the channel at sample reception end can be in contact with each other, or Person may be at one another edge to edge or center to center about 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, In 8mm, 9mm, 10mm, 12mm, 15mm or 20mm.It channel can be diverging from one another from sample reception end.For example, with sample reception end That locates channel holds the opposite channel other end can further away from each other.They can be arrived with one another edge to edge or center Center be separated by greater than or equal to about 3mm, 4mm, 5 mm, 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, 15mm, 20mm, 25mm or 30mm。

In some embodiments, main body 220 can have elongated shape.Main body is at sample reception end 226 or near it There can be one or more conical sections 228.Each side of main body can be gathered in sample reception end.Conical section and/or sample connect Receiving end can be curved.Alternatively, edge can be provided.Taper can be provided at any angle relative to the longitudinal axis of device Partial surface.For example, conical section can be relative to the longitudinal axis at about 5 degree, 10 degree, 15 degree, 30 degree, 45 degree, 60 degree or 75 degree.

The sample reception end 226 of device can contact sample.Sample can be provided directly from subject.Sample reception end can connect Touching subject or the sample for contacting subject or being oozed out from subject.For example, sample reception end is accessible One on subject's finger bleeds liquid.The blood can enter channel.Via capillarity, pressure difference, gravity or it can appoint What his power and the blood is transported by channel.The blood can pass through channel from sample reception end and arrive at sample delivering End.Sample delivery end can be in fluid communication or can be taken to and institute with one or more vessel in the pedestal for being housed in device State vessel fluid communication.Sample can be transferred to vessel from channel.Can via pressure difference, capillarity, gravity, frictional force and/ Or any other power and drive sample to enter in vessel.Optionally, sample can also be is introduced with pipettor, syringe etc. Blood.Although should be appreciated that

Fig. 2 B shows sample B only partially filling channel 222a, 222b, but in most cases, when filling out Filling channel when process is completed will be filled up completely by sample B.

Fig. 3 A- Fig. 3 B show channel 322a, 322b are brought to be housed in device pedestal 340 in one or The example of sample collection device 300 before multiple vessel 346a, 346b fluid communication.Sample collection device may include cap 310, main body 320, bracket 330 and pedestal 340.Main body and/or bracket can support and/or include one, two or more At least part in channel.Pedestal is sustainable and/or includes one, two or more vessel.

In one embodiment, main body 320 and/or bracket 330 can support one or more of sample collection device Channel 322a, 322b.In one example, two channels are provided, but the description as described in two channel embodiments is also applicable In any number of channel, including but not limited to 1,3,4,5,6 or more channel.Each channel can have First end 323a, 323b, the first end may be provided at the sample reception end 326 of device.The first end in each channel can be with It is unlimited.Channel can be opened wide to surrounding air.It, can be by the fluid when fluids such as the first end in contact blood in channel It is sucked into channel.It can via capillarity or herein other any other described technology and draw bloods everywhere.Institute Corresponding second end 325a, 325b in channel can be marched to along the length in channel by stating blood.Channel can be fluidly isolated from one another.Example Such as, fluid can enter first passage 322a, the length across channel via first end 323a, and leave at second end 325a The first passage.Similarly, fluid can enter second channel 322b via first end 323b, the length across channel, and The second channel is left at two end 325b.The first passage and second channel can fluid isolation so that coming from first passage Fluid be not delivered in second channel, and vice versa.In some embodiments, fluid can be transferred to the of channel Two ends are without being first away from.

Channel 322a, 322b can have diverging to configure.For example, compared with second end 325a, 325b in channel, the of channel One end 323a, 323b can be closer each other.It is more compared with that can be provided between the second end in channel between the first end in channel Space.The first end in channel can be in contact with each other or can not contact each other.The first end in channel can be adjacent to each other.

Pedestal 340 can be connected to the bracket 330 of sample collection device.Pedestal 340 can be contacted directly or can not be straight Contact bracket.During the use of device, pedestal can be can be relative to bracket movement.In some embodiments, base Seat can slide in the longitudinal direction relative to bracket.In some cases, pedestal can be slided in the longitudinal direction relative to bracket without revolving Turn.In some cases, pedestal can be coaxially slided with bracket without rotating.In some cases, pedestal can relative to Bracket rotates while mobile.A part of pedestal can be matched in a part of bracket, or vice versa.For example, pedestal A part can be and be inserted into a part of bracket and/or a part of bracket can be and be inserted into In pedestal.One or more limit features can be provided in pedestal and/or frame, with provide between pedestal and bracket by The mobile degree of control.Limit features may include shelf, protrusion or groove.

Pedestal 340 can support one or more vessel 346a, 346b.Pedestal can have can be at least partly Surround the shell of one or more vessel.In some cases, when pedestal is engaged with bracket 330, vessel can be wrapped completely It encloses.Pedestal can have one or more recess, protrusion, groove or moulding feature to receive vessel.Pedestal may be formed to have The shape complementary with the shape of vessel.Vessel can be maintained in the stand up position relative to pedestal.

Vessel with the same number of number in channel can be provided.For example, provided that N number of channel, then can mention For N number of vessel, wherein N is positive integer (for example, 1,2,3,4,5,6,7,8 or more).Each channel can correspond to corresponding device Ware.In one example, sample collection device can have first passage and second channel and corresponding first vessel and Two vessel.First passage 322a can be in fluid communication with the first vessel 346a or can be configured for being taken to and the first vessel 346a is in fluid communication, and second channel 322b can be in fluid communication with the second vessel 346b or can be configured for being taken to It is in fluid communication with the second vessel 346b.

In some embodiments, each vessel can have main body 349a, 349b and cap 348a, 348b.In some cases Under, vessel body can be formed by transparent or semitransparent material.Vessel body allows the sample being provided in vessel body to exist It is visible when from except vessel.Vessel body can have the shape of tubulose.In some cases, vessel body can have There is cylindrical part.The bottom of vessel can be flat, taper, it is mellow and full or any combination thereof.Vessel may include opening End and closed end.Open end can be the top of vessel, can be located at one end closer to one or more channels of vessel. Closed end can be the bottom end of vessel, can be located at one end further from one or more channels of vessel.Can herein its Each embodiment of vessel is more fully described in he everywhere.

Pedestal 340 can have one or more optical indicators, such as optical window 342a, 342b.Optical window can be determined On vessel 346a, 346b.In some cases, optical window can be positioned on vessel body.Single window can be with Observation to single vessel or to multiple vessel is provided.In one example, it is possible to provide with the equal number of optical window of vessel Mouthful.Each optical window can correspond to corresponding vessel.Optical window and vessel can all be formed by light transmitting material, the material Allow whether user has arrived at vessel from the external observation sample of sample collection device.

In some embodiments, there may be the optical windows of channel 322a and 322b, so that user can observe When desired fill level is reached in the channel.In some embodiments that main body 320 is fully transparent or semitransparent In, marker or indicator mark may be present along channel and when reach desired fill level to mark.

The size of vessel can be arranged for accommodating small fluid sample.In some embodiments, vessel can be configured to use In hold no more than about 5ml, 4ml, 3ml, 2ml, 1.5 mL, 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 1nL.Vessel can be configured for Hold no more than several liquid of bleeding, a part for bleeding liquid or liquid of bleeding no more than one.

Vessel may include cap 348a, 348b.Plug can be configured for being matched on the open end of vessel.Cap can hinder Fill in the open end of vessel.Cap can Fluid Sealing vessel.Cap can form fluid-tight sealing with vessel body.For example, cap can be with It is airtight body and/or impenetrable liquid.Alternatively, cap allows certain gases and/or liquid to pass through.In some cases Under, cap can be ventilative and impenetrable liquid.Cap can be sample impermeable.For example, cap is for whole blood, serum Or blood plasma can be it is impermeable.In some cases, a part of cap can be engaged in a part of vessel body.Cap Plug can be formed with vessel body.Cap may include the flange or shelf that can be shrouded on a part of vessel body.It is convex Edge or shelf can prevent cap from sliding into vessel body.In some cases, a part of cap can overlay on the top of vessel body And/or on side.Herein any description of vessel may be applicable to be combined with sample collection device.Optionally, some Embodiment may include the additional component in vessel assembly, such as cap retainer.In one embodiment, cap retainer Purposes be the tight seal maintained between cap and vessel.In one embodiment, cap retainer bond attachments part, flange, Recess or other attachment locations on vessel outside, to retain the cap in appropriate location.Optionally, some embodiments The function of cap and cap retainer can be combined in a component simultaneously.

One or more engagement assemblies can be provided.The engagement assembly may include channel retainer 350 and/or apply Power component, such as spring 352 or rubber belt.In one embodiment, retainer 350 can make adaptor channel 354 keep solid Determine to bracket.If other will be described everywhere herein, adaptor channel 354 can be integrally formed with collection channel, or can be with It is discrete component, can be a part of separate piece, a part of collection channel or vessel.In one embodiment, Retainer 350 can prevent adaptor channel 354 relative to bracket slide.Retainer 350, which can optionally provide, can allow such as bullet The force component such as spring occupy bracket thereon.

In one example, engagement assembly can respectively include spring 352, which can be with applied force so that working as When spring is in its nature, pedestal 340 is in extended state.It, can be in vessel when pedestal is in its extended state 346a, 346b provide space with engaging between assembly.In some cases, when pedestal 340 is in its extended state, lead to The second end in road can contact or can not contact the cap of vessel.The second end of channel 325a, 325b can be at they and device On the position that the inside of ware is not in fluid communication.

Sample collection device can have any number of engagement assembly.For example, can provide identical as the number in channel Number engagement assembly.Each channel can have an engagement assembly.For example, provided that first passage and second Channel can provide the first engagement assembly then for the first passage, and the second engagement assembling can be provided for the second channel Part.Equal number of engagement assembly and vessel can be provided.

In one embodiment, engagement assembly can accommodate adaptor channel 354, such as, but not limited to have angulation The slender member of degree, taper or sharp end 327a and 327b.It should be appreciated that in some embodiments, the end 327a and 327b is a part that the needle of channel 322a and 322b are formed separately and be then coupled to channel 322a and 322b. The needle can be by forming with from the identical or different material of the main body for limiting channel 322a and 322b.For example, some embodiment party Metal can be used to form needle in formula, and then uses polymer or plastics material for the main body for limiting channel 322a and 322b Material.Optionally, some embodiments can form end 327a and 327b on the component being integrally formed with channel 322a and 322b. In some cases, the second end in channel can be configured for penetrable material, cap 348a, 348b of such as vessel.In some realities It applies in mode, a part of adaptor channel 354, which can be, to be inserted into collection channel or one of collection channel It point can be and to be inserted into adaptor channel or the two can be configured to concordantly be aligned.Optionally, some implementations Mode can be such that adaptor channel 354 is integrally formed with collection channel 322a.It should be appreciated that Fig. 3 B (and Fig. 4 B) shows sample Product B only partially filling channel 122a, 122b, but in most cases, channel will when the filling process is finished It is filled up completely by sample B.For embodiments described herein, there may be variations and substitution, and should not will be any Single embodiment is construed to comprising entire invention.

Fig. 4 A- Fig. 4 B shows the example of the sample collection device 400 with channel 422a, 422b, the channel The internal fluid communication of vessel 446a, 446b in 422a, 422b and device.Sample collection device may include cap 410, main body 420, bracket 430 and pedestal 440.Main body and/or bracket can support and/or comprising one, two or more channels At least partially.Pedestal can support and/or comprising one, two or more vessel.

In one embodiment, main body 420 and/or bracket 430 can support one or more in sample collection device A channel 422a, 422b.For example, first passage and second channel can be provided.Each channel can have first end 423a, 423b, first end 423a, 423b may be provided at the sample reception end 426 of device.The first end in each channel can be It is open.Channel can be opened wide to surrounding air.It, can be by the fluid when fluids such as the first end in contact blood in channel It is sucked into channel.Can via capillarity or herein other everywhere any other described technology and suck fluid.Institute Corresponding second end 425a, 425b in channel can be marched to along the length in channel by stating fluid.In some embodiments, fluid The second end in channel can be reached via capillarity or other technologies described herein.In other embodiments, fluid Without reaching the second end in channel.Channel can be fluidly isolated from one another.

In some embodiments, when internal fluid communication when channel not with vessel 446a, 446b, fluid can be transmitted To channel second end and without departing from.For example, fluid can be sucked into channel via capillarity, this can cause fluid It flows to or flows the end in nearly channel without causing fluid leaving channel.

Pedestal 440 can be connected to the bracket 430 of sample collection device.During the use of device, pedestal be can be relatively It is moveable in bracket.In some embodiments, pedestal can slide in the longitudinal direction relative to bracket.In one example, base Seat can have (i) extended position, wherein channel not with the internal fluid communication of vessel, and (ii) compression position, at it The internal fluid communication in middle channel and vessel.The sample collection device under extended state can be initially provided, in Fig. 3 It is shown.After sample has been collected and flows through the length in channel, user can be pushed into pedestal to provide and be in its compression Sample collection device under state, as shown in Figure 4.Once pedestal has been pushed into, then pedestal can keep being pushed into naturally, or Person once removes thrust, then resiliently to extended state.In some cases, pedestal can be pulled out to extended state, Huo Zheke It is pulled out completely to provide the entrance to vessel therein.

Pedestal 440 can support one or more vessel 446a, 446b.Pedestal can have can be at least partly Surround the shell of one or more of vessel.In some cases, when pedestal is engaged with bracket 430, vessel can be complete It is complete to surround.Pedestal can have one or more recess, protrusion, groove or moulding feature to receive vessel.Pedestal is formed as With the shape complementary with the shape of vessel.Vessel can be maintained in the stand up position relative to pedestal.

Vessel with the same number of number in channel can be provided.Each channel can correspond to corresponding vessel.One In a example, sample collection device can have first passage and second channel and corresponding first vessel and the second vessel. First passage 422a can be in fluid communication with the first vessel 446a or can be configured for being taken to and the first vessel fluid Connection, and second channel 422b can be in fluid communication with the second vessel 446b or can be configured for being taken to this second Vessel are in fluid communication.First passage just begin not with the first vessel be in fluid communication, and second channel just begin not with the second device Ware is in fluid communication.When being pushed into pedestal relative to bracket, first passage and second channel can be taken to respectively with the first vessel With the internal fluid communication of the second vessel.First passage and second channel can be taken to and the first vessel and the second vessel simultaneously It is in fluid communication.Alternatively, they are not necessarily to extremely be in fluid communication by band simultaneously.The timing of fluid communication may depend on vessel height and/ Or the length in channel.The timing of fluid communication may depend on the relative distance between the second end in channel and vessel.

In some embodiments, each vessel can have main body 449a, 449b and cap 448a, 448b.Vessel body can Shape with tubulose.In some cases, vessel body can have cylindrical part.The bottom of vessel can be flat, Taper, mellow and full or any combination thereof.Vessel may include open end and closed end.Open end can be the top of vessel, Its one end closer to one or more channels that can be located at vessel.Closed end can be the bottom end of vessel, can be located at vessel One end further from one or more channels.

Pedestal 440 can have one or more optical indicators, such as optical window 442a, 442b.Optical window can be determined On vessel 446a, 446b.In some cases, optical window can be positioned on vessel body.Optical window and device Ware can all be formed by light transmitting material, the material allow user from the external observation sample of sample collection device whether Reach vessel.In some embodiments, vessel may include the marker with vessel sheet to indicate that fill level is wanted It asks.

Vessel may include cap 448a, 448b.Cap can be configured for being matched on the open end of vessel.Cap can block The open end of vessel.Cap can Fluid Sealing vessel.Cap can form fluid-tight sealing with vessel body.For example, cap is for complete Blood, serum or blood plasma can be impermeable.In some cases, a part of cap can be engaged to one of vessel body In point.Cap may include the flange or shelf that can be shrouded on a part of vessel body.In some embodiments, cap There can be hollow or pit.Hollow or pit can help to guide the second end in channel to the center of cap.In some cases, When sample collection device is in extended state, the second end of channel 425a, 425b can be located above the cap of vessel.Channel Second end can contact or can not contact vessel cap.In some cases, the second end in channel can be placed in the hollow of cap Or in pit.In some cases, the second end in channel partly can penetrate cap and be not up to the inside of vessel.Optionally, Some embodiments of cap may include entrainment part to keep vacuum.

The second end in channel can have angled, taper or sharp end 427a and 427b.It should be appreciated that one In a little embodiments, the end 427a and 427b is to be formed separately with channel 422a and 422b and be then coupled to channel 422a With a part of the needle of 422b.The needle can by with the material identical or different from the main body for limiting channel 422a and 422b It is formed.For example, metal can be used to form needle in some embodiments, and the main body for limiting channel 422a and 422b is then Use polymer or plastic material.Optionally, some embodiments can be in the component being integrally formed with channel 422a and 422b Upper formation end 427a and 427b.In some cases, the second end in channel can be configured for penetrable material, such as vessel Cap 448a, 448b.Cap can be formed by the material that can prevent sample from passing through in no penetrating component.Cap can be by single reality Heart part is formed.Alternatively, cap may include any other spy of slit, opening, hole, thin part or acceptable penetrating component Sign.When penetrating component is not in slit or opening, or when penetrating component by from slit or opening remove when, slit or its He is open and can remain in sample wherein.In some cases, cap can be formed by self- recoverage material, so as to when removal When penetrating component, closed by the opening that penetrating component is formed.The second end in channel, which can be, may pass through cap and enters inside vessel Among penetrating component.In some embodiments, it should be apparent that, penetrating component can be the sky for allowing sample to pass through Heart needle, and it is not only used for the needle punctured.In some embodiments, puncture tip can be not coring design, such as but It is not limited to the taper punctured without to cap material coring.

One or more engagement assemblies can be provided.The engagement assembly may include channel retainer 450 and/or Exert a force component, such as spring 452 or rubber belt.In one embodiment, retainer 450 can be such that adaptor channel 454 keeps It is fixed to bracket.If other will be described everywhere herein, adaptor channel 454 can be integrally formed with collection channel, Huo Zheke To be discrete component, a part of separate piece, a part of collection channel or vessel can be.In an embodiment In, retainer 450 can prevent adaptor channel 454 relative to bracket slide.Retainer 450 can optionally provide can allow it is all Such as spring force component occupy bracket thereon.

In one example, engagement assembly may include spring 452, which can be with applied force so that at spring When its nature, pedestal is in its extended state.When pedestal is in its extended state, can vessel 446a, 446b with Space is provided between engagement assembly.The second end of channel 425a, 425b can be at the inside of they and vessel, and fluid does not connect On logical position.

Sample collection device can have any number of engagement assembly.For example, can provide identical as the number in channel Number engagement assembly.Each channel can have an engagement assembly.For example, provided that first passage and second Channel can then provide the first engagement assembly for the first passage, and can provide the second engagement for the second channel Assembly.In one embodiment, equal number of engagement assembly and vessel can be provided.

It, can be with compressed spring 452 when being pressed into pedestal.Second end 425a, 425b in channel can penetrate the cap of vessel. The second end in channel can enter the inside of vessel.In some cases, power can be provided to drive fluid to enter device from channel In ware.For example, pressure difference can be generated between the first end and second end in channel.At first end 423a, 423b in channel It can provide positive pressure and/or can provide negative pressure at the second end in channel.Positive pressure can relative at the second end in channel and/ Or the pressure of surrounding air is positive.Negative pressure can be relative at the first end in channel and/or the pressure of surrounding air is negative.One In a example, vessel can have vacuum wherein.When second end when channel penetrates vessel, the negative pressure in vessel can be by sample It pulls in vessel.In the alternative, sample can enter vessel by capillary force, gravity or any other power drive. In embodiments, vessel do not have vacuum wherein.For embodiments described herein, there may be change and replace Generation, and any single embodiment should not be construed to comprising entire invention.

In some cases, different types of power can be used in the different phase of sample collection.Therefore, can make It is sucked the sample into a type of power into channel, and different types of power then can be used by sample It is moved in vessel from channel.For example, capillary force can be sucked the sample into channel, and pressure difference can be by sample from channels drive Into vessel.Any combination of power can be used suck the sample into channel and vessel in.In some embodiments In, one or more power for sucking sample into channel are different from one kind or more for sucking sample into vessel Kind power.In some alternate embodiments, one or more power can be each stage identical.In some realities It applies in mode, applies one or more power in order or in a limited time period.For lifting non-limiting example, do not apply To suck one or more power of sample into vessel, until at least one channel has reached minimum fill level.It is optional Ground, do not apply into vessel suck sample one or more power, until at least two channels respectively reached for The minimum fill level in the channel.Optionally, do not apply one or more power to suck sample into vessel, until All channels have respectively reached the minimum fill level for the channel.In some embodiments, while applying one kind Or a variety of power.

Pressurized gas source can be used in some embodiments, and the pressurized gas source is coupled to sample collection device and is matched It sets for the body fluid being collected into be pushed into its corresponding vessel from one or more channels.Optionally, some embodiments can To use vacuum source not associated with vessel that sample fluid is pulled to vessel.

In addition, some embodiments in channel may be configured such that there are enough capillary forces in channel, thus once It is filled, which is greater than gravity so that sample will not be based only upon gravity and escape from channel.Broken using additional power The holding of the capillarity in one or more channels.Optionally, such as this paper, other are described everywhere, such as, but not limited to sleeve Equal devices can receiving body fluids to prevent it leaving channel at one end near vessel, to make any minimization of loss, until Start the transfer to vessel.

It is alternatively possible to which ball (lyosphere), sponge or other power are such as, but not limited to lyophilized using other materials Object etc. is provided, to provide the power for sucking sample into vessel.When using multiple power, this be can be to inhale into vessel Enter the primary, secondary or three-level power of sample.Optionally, some embodiments may include pushing-type power supplier, such as but It is not limited to plunger, to carry out mobile example in the desired manner.

After sample has been introduced in channel, it may pass through some times, so that sample is along the length row in channel Into.User can introduce the sample into sample collection device, and the sample can be waited to advance along the length in channel.It can To provide one or more optical indicators, it can refer to whether sample product have reached desired fill level, such as but not It is limited to reach the end in channel.In other embodiments, before being pushed into pedestal, user can wait the time of predetermined amount. User have determined sample advanced up to the sufficient length in channel and/or pass by from introducing sample enough After the time of amount, pedestal can be pushed into.After being pushed into pedestal, channel can be taken to be in fluid communication with vessel, and sample Product can flow into vessel from channel.Optical indicator can be provided, so that user is known that when vessel are filled.

Once vessel are filled, then can be used herein other everywhere described system and method by its turn Move to desired place.In some cases, entire sample collection device can be shifted.Cap can be placed on sample collection For shifting on device.In other embodiments, can be can be from its remaining part of device for base part and/or holder part Divide removal.In one example, can by pedestal from sample collection device remove, and vessel can together with pedestal by Transfer.Alternatively, pedestal can be removed from sample collection device to provide the entrance to vessel, and can be removed from device With transmission vessel.The removal of pedestal can be related to some dismantlings of sample collection device to unload bottom base.This may involve the use of Enough power come overcome be built in it is in device, for preventing the retainer undesirably fallen off or locating part.Optionally, it is unloading Some other initiatives can be carried out by user before pedestal, such as, but not limited to disengagement latch or other locking mechanisms.It can Selection of land, some embodiments, which can permit, removes vessel without removing pedestal, but allows through the opening on pedestal, upstream end Mouth or the mode that can open wide covering enter vessel.

In some embodiments, one or more of the channel and/or vessel may include other each places this paper The feature of description, such as separating member, coating, anti-coagulants, bead or any other feature.In one example, it is introduced into sample The sample of product collection device can be whole blood.Two channels and corresponding vessel can be provided.In the non-limiting example, Each channel has coating, the anti-coagulants coating such as, but not limited in channel.Such anti-coagulants coating can play one or Multiple following functions.Firstly, anti-coagulants can prevent whole blood from condensing in channel during sample collection process.Depending on being wanted The botal blood volume of collection, condensation may before the blood of sufficient amount is brought into channel prematurely blocking channel.Another function It can be that anti-coagulants is introduced into whole blood sample.By having anti-coagulants in the channel, relative to may only in vessel 446a or There are some embodiments of anti-coagulants, which can start earlier during collection in 446b.Will be along can Access with the part (being such as, but not limited to connected to the inner surface of the needle of channel 422a or 422b) for being not coated with anti-coagulants And in the case where guiding whole blood sample, the introducing of such early stage of anti-coagulants is also possible to advantageous.Optionally, some implementations Mode may include the surfactant that can be used for changing the contact angle (wettable) on surface.

In some embodiments, the inner surface in channel and/or the other surfaces along fluid passage, it is such as but unlimited In leading to the sample inlet inside sample collection vessel, surfactant and/or anti-coagulants solution can be coated with.Surface is living Property agent provides wettable surface for the hydrophobic layer of fluid means, and promotes measurement channel by fluid samples such as such as blood Filling.Anti-coagulants solution helps prevent the condensation when providing to fluid means of the sample such as blood.What be can be used is exemplary Surfactant include but is not limited to Tween,20、NaTDC, Triton,Other non-hemolytic decontaminations of the appropriate wetting characteristics of X-100, Pluronic and/or offer surfactant Agent.EDTA and heparin are the non-limiting anti-coagulants that can be used.In a non-limiting example, solution in embodiment Include 2%Tween, 25mg/mL EDTA in 50% methanol/50%H2O, is then air cured.Methanol/water mixture mentions Method for dissolving EDTA and Tween, and also dried rapidly from the surface of plastics.It can be by will ensure that on the surface Any technology (for example, liquid relief, injection, printing or wicking) for coating uniform film, to apply a solution to channel or along stream The other surfaces of body flow passage.

It is also understood that the coating in channel can be along the entire path in channel for any embodiment of this paper Extend.Optionally, coating can cover the most of but not all of channel.Optionally, some embodiments are near entrance Channel can not be covered in the region of opening so that cross contamination risk minimization, wherein by make all channels all with Target sample fluid contacts and thereby has simultaneously the mode of the fluid passage of connection, and the coating material from a channel moves In channel near moving to.

Although embodiments described herein is shown as the channel with two separation being located in sample collection device, It is to be understood that the channel of more than two separation can be used in some embodiments.Optionally, some embodiments can make With less than two channels being kept completely separate.The channel of a separation can be used only in some embodiments.Optionally, Yi Xieshi The channel of falling Y shape can be used in the mode of applying, and is somebody's turn to do the channel of falling Y shape and a channel is initially used as to start, and be then divided into two or more A channel.Any concept in these concepts may be adapted to be used together with other embodiments described herein.

Collection device with self-supporting collection channel

Fig. 5 A- Fig. 5 B provides the another of the sample collection device 500 provided according to embodiments described herein Example.The sample collection device may include collection device main body 520, bracket 530 and pedestal 540.In some cases, optionally Cap can be provided.Collection device main body may include being received as that can receive one or more defined by the collecting pipe of sample Collect channel 522a, 522b.Pedestal can have one or more optical indicator 542a, 542b, and the optical indicator can mention For whether reaching visually indicating for the one or more vessel being contained in pedestal to sample.Bracket can have one or more Optical indicator 532a, 532b, the optical indicator can provide a part that channel whether is reached to or through to sample Visually indicate.

The collection device main body 520 of sample collection device can be wherein comprising one or more with channel 522a, 522b At least part of a pipe.Optionally, device collection main body 520, which can also limit, is coupled to the channel as defined by the pipe The channel of 522a, 522b.In some embodiments, a part in the channel is extensible exceeds collection device main body.It is logical The extensible one or both ends beyond collection device main body in road.

Collection device main body 520 can be connected to bracket 530.Bracket can be in one wherein comprising one or more channels Point.Collection device main body can be permanently attached to the bracket, or can be relative to the bracket can be removed.In some cases Under, collection device main body and bracket can be formed by single single piece.Alternatively, collection device main body and bracket can by separate zero Part is formed.

During the operation of the device, collection device main body 520 and bracket 530 can be moved relative to each other.In some cases Under, a part of main body 520, which can be, to be inserted into bracket 530 and/or a part of bracket can be to insert It is intracorporal to enter master.The main body can be moved relative to bracket.In some cases, sample collection device can have edge The sample collection device length extend the longitudinal axis.Main body and/or bracket can be relative to each other on the directions of the longitudinal axis It is mobile.Main body and/or bracket can be moved relative to each other limited distance.Main body and/or bracket can move without spin In the case where coaxially move.Alternatively, rotary motion can be provided.

Collection device main body 520 can be formed by light transmitting material.For example, collection device main body can be by transparent or semitransparent Material is formed.Alternatively, main body can be formed by opaque material.Bracket 530 can be by optically opaque, translucent or transparent material It is formed.Bracket can have or can not have optical characteristics identical with collection device main body.Bracket can by with receipts The different material of acquisition means main body is formed, or is formed by material identical with collection device main body.For described herein There may be variations and substitution for embodiment, and should not be construed to any single embodiment comprising entire invention.

Collection device main body, bracket and/or pedestal can have any shape or size.In some instances, collection device Main body, bracket and/or pedestal can have circle, ellipse, triangle, quadrangle (for example, square, rectangle, trapezoidal), five Side shape, hexagon, octagon or any other cross-sectional shape.Along length, cross-sectional shape can keep it is identical or It can change.For main body, bracket and/or pedestal, cross-sectional shape can be identical or can change.In some cases, Collection device main body, bracket and/or pedestal can have less than or equal to about 10cm²、7cm²、5cm²、4cm²、3cm²、2.5 cm²、 2cm²、1.5cm²、1cm²、0.8cm²、0.5cm²、0.3cm²Or 0.1cm²Cross-sectional area.Along length, cross-sectional area can become Change or can keep identical.Can be identical or can change for collecting main body, bracket and pedestal, cross section size. Collection device main body, bracket and/or pedestal can have less than or equal to about 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, The length of 6cm, 5cm, 4cm, 3cm, 2 cm, 1cm, 0.5cm or 0.1cm.Collection device main body can have than bracket or pedestal more Big or smaller length, or the length equal with bracket or pedestal.

Channel 522a, 522b can be supported by apparatus main body 520 and/or bracket 530.In some cases, pipe or in which The overall length in channel can be comprised within the combination of apparatus main body and bracket.Alternatively, channel is extensible to exceed apparatus main body And/or bracket, as seen in Figure 5.In some cases, channel is extensible beyond apparatus main body/holder combination one end, or Person extends beyond both end.In some cases, a part in channel can be within apparatus main body, and the one of channel Part can be within bracket.The position in channel can be fixed by apparatus main body and/or bracket.In some cases, channel can It is fixed to apparatus main body and/or not relative to apparatus main body movement.Channel can be moveable relative to bracket.? Under some cases, multiple channels can be provided.At least part in channel can be substantially parallel to each other.Channel can be parallel to that The longitudinal axis of this and/or the length extension along sample collection device.Alternatively, any part in channel be all not necessarily to it is parallel to each other. In some cases, at least part in channel is not parallel to each other.It channel can slight curvature.Optionally, they can be straight , but be aligned to be closer to each other when they are close to sample collection point.It should be appreciated that limiting channel 522a and 522b Pipe can by optically transparent material, transmission material or other be enough to provide sample and have reached expectation at least one channel Made by the material of the detectable change of fill level.Optionally, the detectable change can be used for detecting whole two and lead to When road is at least up to desired fill level.

It can provide pedestal 540 in sample collection device.The pedestal can be connected to bracket 530.In some cases, base A part of seat 540, which can be, to be inserted into bracket 530 and/or a part of bracket can be and be inserted into base In seat.Pedestal can be fixed relative to bracket, or can be moveable relative to bracket.Pedestal may be provided in and connect One end of the bracket opposite to one end of the bracket of main body.Pedestal is formed as the part separated with bracket.Pedestal can be can It is separated from bracket.Alternatively, pedestal can be fixed to bracket and/or be formed as single piece with bracket.

Pedestal 540 can accommodate one or more vessel wherein.The vessel can with passage, and/or It can be taken to and passage.The one end in channel can be in vessel, or can be taken in vessel.Pedestal can have One or more optical indicator 542a, 542b, the optical indicator can provide be contained in pedestal to whether sample reaches In one or more vessel visually indicate.In some embodiments, optical indicator, which can be, aloows user Check the optical window into pedestal.The optical window can be formed by transparent and/or trnaslucent materials.Alternatively, optical window can To be in the wherein not no opening of any material.Optical window can enable a user to directly observe the vessel in pedestal. Vessel in pedestal can be formed by transparent and/or trnaslucent materials, can enable a user to check whether sample has arrived Up to the vessel of the pedestal.For example, vessel can show blood therein if blood is transported to vessel along channel.? In other embodiments, optical indicator may include other features that can be indicated vessel and be filled.For example, can be in base One or more sensors are provided in seat or vessel, the sensor may determine whether to provide in vessel enough The sample of amount.The sensor can optical indicator on pedestal signal is provided, which may indicate whether to device The sample size that ware provides sample and/or provides to vessel.For example, optical sensor may include display, such as LCD display, optical display unit (for example, LED display), plasma screen displays, can provide abundant to vessel The instruction of filling.In the alternative, without providing optical indicator, but the indicator of substitution can be provided, such as But being not limited to can be by detectable signal (signal that can be such as detected by user) instruction vessel in when being filled Audio indicator, temperature control indicator or other devices.

Bracket 530 can have one or more optical indicator 532a, 532b, and the optical indicator can provide to sample Whether product reach to or through visually indicating for a part in the channel accommodated by bracket.In some embodiments, optics refers to Showing that device can be aloows user to see the optical window into bracket.Optical window can be by transparent and/or translucent material Material is formed.Alternatively, optical window can be in the wherein not no opening of any material.Optical window can enable a user to Directly observe a part in the channel in bracket.Channel can be formed by transparent and/or trnaslucent materials, can make user It can check whether sample has arrived at the part in the channel below optical window.In other embodiments, optics indicates Device may include other features that can be had already passed through a part in channel to sample and be indicated, such as other each places this paper The sensor of description.

Referring now to Fig. 6 A- Fig. 6 B, the attached of sample collection device 500 is provided according to an embodiment described herein Add view.

In some embodiments, a part of the pipe comprising channel 522a, 522b is extensible to exceed collection device main body 520.The part in the channel extended may include the part for being configured for receiving the channel of the sample from subject.One In a example, channel can have first end 523a, 523b, which can be the sample reception end in channel.

Channel can optionally be limited by rigid material.Alternatively, channel can be limited by flexible material, Huo Zheke With flexible unit.Channel can be designed to or can be not designed for bending or be bent.It channel can be basic It is upper parallel to each other, or can not be substantially parallel to each other.In some cases, the first end in channel is being in relaxed state When can be separated by a distance.The first end in channel can keep being separated by the distance during device operates.Alternatively, the of channel One end can be taken to mutually closer to.For example, the first end in channel can be crowded together.Each open end in channel can be single Solely receive sample.Sample can be received in order.Sample can come from same subject.Alternatively, channel can be same When receive same sample.

Channel 522a, 522b may include other one or more features or characteristic for mentioning everywhere herein.Channel is at least A part can be substantially parallel to each other.Alternatively, channel can be at an angle relative to each other.In some embodiments, channel can have There is first end, which can be located at the sample reception end 526 of sample collection device.The first end in channel can be can Receive the open end of sample.In some embodiments, each channel can be provided at the sample reception end of sample receiving device The end.One, two or more channel can have the first end at the sample reception end of sample collection device.

In some embodiments, apparatus main body 520 can be moveable relative to bracket 530.The one of apparatus main body Part, which can be, to be inserted into bracket, or vice versa.In one example, apparatus main body can have 527 He of flange Interior section 529.Flange can have the cross-sectional area bigger than interior section.Interior section can be inserted into bracket In.Flange may act as to prevent entire main body to be inserted into the locating part in bracket.Flange can be located on the shoulder of bracket.

Fig. 7 A- Fig. 7 B shows the example of the sample collection device 700 provided according to embodiments described herein Partial sectional view.Channel 722a, 722b are brought to be housed in device pedestal 740 in one or more vessel Before 746a, 746b are in fluid communication, sample collection device is in extended state.Sample collection device may include main body 720, branch Frame 730 and pedestal 740.Main body and/or bracket are sustainable and/or at least one comprising one, two or more channel Point.Pedestal is sustainable and/or includes one, two or more vessel.For embodiments described herein there may be Variation and substitution, and any single embodiment should not be construed to comprising entire invention.

In one embodiment, main body 720 and/or bracket 730 can support one or more of sample collection device Channel 722a, 722b.In one example, two channels are provided, but the description as described in two channel embodiments is also applicable to Any number of channel, including but not limited to 1,3,4,5,6 or more channel.Each channel can have One end 723a, 723b, the first end can be the sample reception end of device.The first end in each channel can be unlimited.It is logical Road can be opened wide to surrounding air.When fluids such as the first end in contact blood in channel, which can be sucked into channel In.Can via capillarity or herein other any other described technology sucks fluid everywhere.The fluid can edge The length in channel march to the corresponding second end in channel.Channel can be fluidly isolated from one another.For example, fluid can be via first end 723a enters first passage 722a, the length across channel, and the first passage is left at second end.Similarly, fluid Second channel 722b, the length across channel can be entered via first end 723b, and leave the second channel at second end. The first passage and second channel can fluid isolation, so that the fluid from first passage is not transmitted into second channel, and Vice versa.In some embodiments, fluid can be transferred to the second end in channel without being first away from.

Channel 722a, 722b can have configured in parallel.For example, first end 723a, 723b in channel can at a distance of and channel Second end approximately the same distance.The first end in channel can be in contact with each other or can not be in contact with each other.

Bracket 730 can have one or more optical indicators, such as optical window 732a, 732b.Optical window can be determined On channel 722a, 722b.In some cases, optical window can be positioned on the part in channel.Single window can Observation to single channel part or to multiple channel parts is provided.In one example, number identical as channel can be provided Purpose optical window.Each optical window can correspond to corresponding channel.Optical window and channel all can be by light transmitting material shapes At whether permissible user has arrived at from the external observation sample of sample collection device and/or across following channel part Point.Such determination be determined for when compression sample collection device.

Pedestal 740 can be connected to the bracket 730 of sample collection device.The pedestal can be contacted directly or can not be straight Contact bracket.During the use of device, pedestal can be fixed relative to bracket.In some cases, can be can be from for pedestal What bracket removed.A part of pedestal, which can be, to be inserted into bracket, and/or vice versa.In some implementations In mode, pedestal can be skidded off on the longitudinal direction relative to bracket from bracket.In some cases, pedestal can coaxially be slided with bracket It moves without rotating.In some cases, pedestal can rotate while mobile relative to bracket.

Pedestal 740 can support one or more vessel 746a, 746b.Pedestal can have can be at least partly Surround the shell of one or more of vessel.In some cases, when pedestal is engaged with bracket 730, vessel can be complete It is complete to surround.The extensible height beyond vessel of the height of pedestal.Alternatively, the height of pedestal may extend to the height phase with vessel Same degree or the height less than vessel.Pedestal can have one or more recess, protrusion, groove or moulding feature to receive Vessel.Pedestal may be formed to have the shape complementary with the shape of vessel.For example, pedestal can have one or more tubuloses recessed It falls into, tubulose vessel can be closely engaged to wherein.Vessel can frictional fit into pedestal.Vessel can be maintained at relative to In the stand up position of pedestal.For embodiments described herein, there may be variations and substitution, and should not will be any Single embodiment is construed to comprising entire invention.

Vessel with the same number of number in channel can be provided.For example, provided that N number of channel, then can provide N number of vessel, wherein N is positive integer (for example, 1,2,3,4,5,6,7,8 or more).Each channel can correspond to corresponding device Ware.In one example, sample collection device can have first passage and second channel and corresponding first vessel and Two vessel.First passage 722a can be in fluid communication with the first vessel 746a or can be configured for being taken to and first device Ware be in fluid communication, and second channel 722b can with the second vessel 746b be in fluid communication or can be configured for being taken to Second vessel are in fluid communication.

In some embodiments, each vessel can have main body 749a, 749b and cap 748a, 748b.Vessel can have As herein other everywhere described in any feature or characteristic.

Pedestal 740 can have one or more optical indicators, such as optical window 742a, 742b.Optical window can be determined On vessel 746a, 746b.In some cases, optical window can be positioned on vessel body.Single window can mention For the observation to single vessel or to multiple vessel.In one example, it can provide and the equal number of optical window of vessel Mouthful.Each optical window can correspond to corresponding vessel.Optical window and vessel can all be formed by light transmitting material, can be permitted Whether family allowable has arrived at vessel from the external observation sample of sample collection device.Such visual assessment can be used for determining When sample reaches vessel, and when can remove pedestal from sample collection device.

One or more engagement assemblies can be provided.The engagement assembly may include channel retainer 750 and/or Exert a force component, such as spring 752 or rubber belt.In one embodiment, retainer 750 can be such that adaptor channel 754 keeps Fixed to bracket.If other will be described everywhere herein, adaptor channel 754 can be integrally formed with collection channel, Huo Zheke To be discrete component, a part of separate piece, a part of collection channel or vessel can be.In an embodiment In, retainer 750 can prevent adaptor channel 754 relative to bracket slide.Retainer 750 can optionally provide can allow it is all Such as spring force component occupy bracket thereon.

In one example, engagement assembly may include spring 752, the spring can applied force so that when spring is in When its nature, main body 720 is in extended state.When main body is in its extended state, can vessel 746a, 746b with Space is provided between engagement assembly.When main body is in its extended state, the interior section 729 of main body can be by bracket 730 It exposes and/or discloses.In some cases, when main body is in its extended state, the second end of channel 722a, 722b can To contact or can not contact the cap of vessel.The second end in channel can be at the position not being in fluid communication inside they and vessel It sets.For embodiments described herein, there may be variations and substitution, and should not be by any single embodiment party Formula is construed to comprising entire invention.

Sample collection device can have any number of engagement assembly.For example, can provide identical as the number in channel Number engagement assembly.Each channel can have engagement assembly.For example, provided that first passage and second channel, First engagement assembly can be then provided for the first passage, and the second engagement assembling can be provided for the second channel Part.Equal number of engagement assembly and vessel can be provided.

Fig. 8 A- Fig. 8 B provides the example of the sample collection device 800 with channel 822a, 822b, the channel and dress The internal fluid communication of vessel 846a, 846b in setting.Sample collection device may include main body 820, bracket 830 and pedestal 840.Main body and/or bracket be sustainable and/or at least part comprising one, two or more channel.Channel can prolong Stretch one end beyond main body.Pedestal is sustainable and/or includes one, two or more vessel.

In one embodiment, main body 820 and/or bracket 830 can support one or more of sample collection device Channel 822a, 822b.For example, first passage and second channel can be provided.Each channel can have first end 823a, 823b, The first end can be provided at the sample reception end of the extensible device beyond main body.The first end in each channel can be It is open.Channel can be opened wide to surrounding air.Channel can be rigid or can be flexible.In some embodiments In, channel can have allow its bending with length contacting one another.When the first end in contact blood etc. in channel When fluid, which can be sucked into channel.Each tunnel ends can individually contact fluid, which can be sucked into phase In the channel answered.This can be related to the angle for adjusting sample collection device, so that only entering in channel in any time One opening is in contact with sample fluid.Alternatively, all channels can contact same sample simultaneously, the sample be sucked simultaneously to In corresponding channel.Alternatively, multiple but not all channel can contact same sample simultaneously, which is then sucked simultaneously Into corresponding channel.Can via capillarity or herein other any other described technology sucks fluid everywhere. The fluid can march to the corresponding second end in channel along the length in channel.In some embodiments, fluid can be via Capillarity or other technologies described herein and the second end for reaching channel.In other embodiments, fluid is without arriving Up to the second end in channel.Channel can be fluidly isolated from one another.

In some embodiments, when internal fluid communication when channel not with vessel 846a, 846b, fluid can be transmitted To channel second end and without departing from.For example, fluid can be sucked into channel via capillarity, this can cause fluid It flows to or flows the end in nearly channel without causing fluid leaving channel.

During the use of device, main body 820 can be moveable relative to bracket 830.In some embodiments In, main body can be in the vertical upward sliding relative to bracket.In one example, main body can have (i) extended position, wherein Channel is not with the internal fluid communication of vessel, and (ii) compression position, the internal fluid communication in wherein channel and vessel. The sample collection device in extended state can be initially provided, as shown in Figure 7.It has been collected and has flowed through in sample After the length in channel, user can be pushed into main body to provide the sample collection device for being in its compressive state, such as institute in Fig. 8 Show.In some cases, when main body is in extended state, the interior section of main body is exposed.When main body is in compression shape When state, the interior section of main body can be covered by bracket.The flange of main body can contact bracket.Once main body has been pushed into, then lead Body can keep being pushed into naturally, or once remove thrust, then resiliently to extended state.In some cases, main body can It is pulled out to extended state, or can be pulled out completely to provide the entrance to vessel therein.Optionally, in some assemblings In part, the removal of main body will not provide the entrance to vessel.

Pedestal 840 can be connected to the bracket 830 of sample collection device.Pedestal 840 can support one or more devices Ware 846a, 846b.Pedestal can have can be at least partially around the shell of one or more of vessel.In some cases Under, when pedestal is engaged with bracket 830, vessel can be entirely surrounded by.Pedestal can have one or more recess, protrusion, Groove or moulding feature are to receive vessel.Pedestal may be formed to have the shape complementary with the shape of vessel.It can keep vessel In the stand up position relative to pedestal.

Vessel with the same number of number in channel can be provided.Each channel can correspond to corresponding vessel.One In a example, sample collection device can have first passage and second channel and corresponding first vessel and the second vessel. First passage 822a can be in fluid communication with the first vessel 846a or can be configured for being taken to and the first vessel fluid Connection, and second channel 822b can be in fluid communication with the second vessel 846b or can be configured for being taken to this second Vessel are in fluid communication.First passage just begin not with the first vessel be in fluid communication, and second channel just begin not with the second device Ware is in fluid communication.When being pushed into main body relative to bracket, first passage and second channel can be taken to respectively with the first vessel With the internal fluid communication of the second vessel.First passage and second channel can by band simultaneously to the first vessel and the second vessel It is in fluid communication.Alternatively, they are not necessarily to extremely be in fluid communication by band simultaneously.The timing of fluid communication may depend on vessel height and/ Or the length in channel.The timing of fluid communication may depend on the relative distance between the second end in channel and vessel.

In some embodiments, each vessel can have main body 849a, 849b and cap 848a, 848b.Vessel body can Shape with tubulose.In some cases, vessel body can have cylindrical part.The bottom of vessel can be flat, Taper, mellow and full or any combination thereof.Vessel may include open end and closed end.Open end can be the top of vessel, Its one end closer to one or more channels that can be at vessel.Closed end can be the bottom end of vessel, can be at vessel One end further from one or more channels.For embodiments described herein, there may be variations and substitution, and Any single embodiment should not be construed to comprising entire invention.

Bracket 830 can have one or more optical indicators, such as optical window 832a, 832b.Optical window can be determined On the part of channel 822a, 822b.Optical window can provide whether have arrived at and/or passed through by the light to sample Learn the instruction of the part in channel shown by window.This can be used for assessing whether sample has sufficiently flowed so that user will lead Body is pushed into sample collection device.In some cases, it can be possible to it is expected that sample is causing channel and vessel to enter fluid communication It is reached near the second end in channel or the second end in channel before.In some cases, sample may need push-in main body with Channel is brought to the specific part that arrival channel before is in fluid communication with vessel.The specific part in the channel can be located at optics Under window.

Pedestal 840 can have one or more optical indicators, such as optical window 842a, 842b.Optical window can be determined On vessel 846a, 846b.In some cases, optical window can be positioned on vessel body.Optical window can mention For whether coming into the instruction of vessel to sample.How many sample optical window can show and have been filled with vessel.This can For assessing whether that the sample of existing sufficient amount enters vessel.In some cases, vessel are being connected from the fluid in channel Before logical removal, it may be desirable to which the sample of specific quantity enters the vessel.In the pedestal for removing device to which vessel are taken away and be led to Before the fluid communication in road, it may be desirable to the sample of the predetermined volume in vessel.

Vessel and/or can have any characteristic or feature with the interface in channel, such as other are described special everywhere herein Property or feature.In some cases, the second end in channel can penetrate the cap of vessel, connect to bringing in channel to vessel fluid It is logical.In some cases, channel can be withdrawn from from vessel, and the cap of vessel can form fluid-tight sealing, thus when logical When road is brought away from the fluid communication with vessel, allow fluid-tight environment in vessel.

One or more engagement assemblies can be provided.The engagement assembly may include channel retainer and/or force Component, such as spring or rubber belt.Retainer can make channel remain fixed to main body.Retainer can prevent channel relative to master Body sliding.Retainer can optionally provide the bracket that the force component such as spring can be allowed to occupy thereon.

In one example, engagement assembly may include spring, the spring can applied force so that when spring be in its oneself When right state, main body is in its extended state.It, can be in vessel 846a, 846b and sample master when main body is in its extended state Space is provided between the bottom part of body 820.The second end in channel can be at the position not being in fluid communication inside they and vessel It sets.

It, can be with compressed spring 852 (see also Fig. 9 A- Fig. 9 C) when being pressed into main body.The second end in channel can penetrate vessel Cap.The second end in channel can enter the inside of vessel.In some cases, it is possible to provide power with by fluid from channels drive to device In ware.For example, pressure difference can be generated between the first end and second end in channel.At first end 823a, 823b in channel It can provide positive pressure and/or can provide negative pressure at the second end in channel.Positive pressure can relative at the second end in channel and/ Or the pressure of surrounding air is positive.Negative pressure can be relative at the first end in channel and/or the pressure of surrounding air is negative.One In a example, vessel 846a and 846b can respectively have vacuum wherein.When second end when channel penetrates vessel, in vessel Negative pressure can will be in sample inspiration vessel.In the alternative, sample can be by capillary force, gravity or any other power It drives and enters vessel.It is alternatively possible to which there are the single or multiple combinations of power to fill vessel with fluid.

In some cases, different types of power can be used and suck sample into vessel into channel and from channel Product.For example, capillary force can be sucked the sample into channel, and pressure difference can by sample from channels drive into vessel.It can be used Any combination of power sucks sample into channel and into vessel.

After sample has been introduced in channel, it may pass through some times, so that sample is along the length row in channel Into.User can introduce the sample into sample collection device, and the sample can be waited to advance along the length in channel.It can To provide one or more optical indicators of the length along channel, the end whether sample product have arrived at channel can refer to End.In other embodiments, before being pushed into main body, user can wait the time of predetermined amount.Sample is had determined in user Product advanced up to channel sufficient length and/or pass by sufficient amount from introducing sample time after, can be with It is pushed into main body.Main body can have flat surfaces, which can be easy to user's promotion.In some cases, the flat table Face can have the cross-sectional area that can be enough that the finger of user is allowed to press down in main body.After being pushed into main body, channel can It is taken to and is in fluid communication with vessel, and sample can flow into vessel from channel.Optical indicator can be provided, so that handy Family is known that when vessel are filled.

Once vessel are filled, then can be used herein other everywhere described system and method by its turn Move to desired place.As it was noted above, entire sample collection device can be shifted.In other embodiments, base part Can be can be from the removal of the rest part of device.In one example, pedestal can be removed from sample collection device, and Vessel can be transferred together with pedestal.Alternatively, pedestal can be removed from sample collection device with provide to vessel into Enter, and can remove and transmit vessel from device.

With reference to Fig. 9 A- Fig. 9 B, the example of sample collection device 900 and application method will now be described.It is non-limiting at one In example, which can have main body 920, bracket 930 and pedestal 940.Main body 920, bracket 930 and pedestal 940 can be phase For moveable each other.In some cases, the various components of device can be moves during different service stages 's.The example of service stage may include when device is in extended state, compressive state and discrete state.

Fig. 9 A shows the example that device 900 is in extended state.Main body 920 can be relative to stent.It is configured to use Main body can be fixed in channel 922a, the 922b for transporting sample.The first end in channel can be from main body and/or sample collection device Rest part extend out.The second end in channel can be located in a part of sample collection device or by it.It is logical It road can be to the corresponding vessel fluid isolation that is accommodated by pedestal 940.Bracket 930 can be positioned between main body and pedestal.Bracket can be extremely It partially include a part in channel.In some cases, bracket may include the second end in channel.

When being in extended state, device can have the length of stretching, extension.The length of device can be from the bottom of pedestal to The first end in channel.Alternatively, the length of device can top from the bottom of pedestal to main body measure.

As seen in Fig. 9 A, when sample is introduced to device, device 900 can be at extended state.For example, sample can be by At least first end in channel is contacted.Can come via capillarity or any other technology described herein or power to Sample is sucked in channel.Power can independent role or compound action to suck sample into device.When sample is just in passage lanes When, device 900 can keep being in extended state.Sample can be with the overall length of filling channel, a part of passage length or at least most Fraction, to meet desired sample acquisition volume.

Fig. 9 B shows the example that device 900 is in compressive state.Main body 920 can be compressed relative to bracket.Channel 922a, 922b can be fixed to main body.It channel can vessel fluid communication corresponding with them.When device is taken to compressive state, First passage can be taken to the internal fluid communication with the first vessel, and second channel can be taken to in the second vessel Portion is in fluid communication.

For lifting non-limiting example, user can push main body 920 (or vice versa) to incite somebody to action towards bracket 930 Device band is to compressive state.Relative motion between component can be related to the movement of the two parts.Optionally, movement can be related to Only move one among them.In this example, main body 920 can be shifted onto bracket 930 always, so that main body is appointed What interior section does not expose and/or the Hp contacts bracket of main body.Can be used can connect when device is fully compressed Any stop mechanism closed.Alternatively, main body can be pushed only partially.For example, one of the interior section of main body can be exposed Point.Bracket can be positioned between main body and pedestal.Bracket can at least partly include a part in channel.In some cases Under, the extensible bracket beyond device of the second end in channel.

When in its compressed state, it should be understood that device 900 can have reduction length.The length of device 900 can be From the bottom of pedestal to the first end in channel.Alternatively, the length of device can top from the bottom of pedestal to main body survey Amount.The reduction length of device is smaller than the spread length of device.In some embodiments, the reduction length of device can compare The spread length of device small at least about 0.1cm, 0.5cm, 1.0cm, 1.5cm, 2.0cm, 2.5cm, 3.0cm, 3.5cm, 4.0cm Or 5.0cm.The reduction length of device can be less than or equal to device spread length about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97% or 99%.

One or more engagement assemblies can be provided with device 900.The engagement assembly may include channel retainer 950 and/or force component, such as spring 952 or rubber belt.Retainer 950 can make adaptor channel 954 remain fixed to branch Frame.If other will be described everywhere herein, adaptor channel 954 can be integrally formed with collection channel, or can be discrete Element can be a part of separate piece, a part of collection channel or vessel.In one embodiment, retainer 950 can prevent adaptor channel 954 relative to bracket slide.Retainer 950, which can optionally provide, can allow spring etc. to be applied Power component occupy bracket thereon.When device is when in a compressed state, the force component such as spring can be at compressive state. When device is when in a compressed state, spring can main body applied force to device.

When sample is shifted from channel to corresponding vessel, device can be at compressive state.It in some instances, can be with It is shifted via the pressure difference between channel and vessel inside when they are taken to fluid communication.For example, the second of channel End can be taken to the internal fluid communication with vessel.Vessel can have vacuum and/or negative pressure wherein.When channel be taken to When vacuum utensil is in fluid communication, sample can be sucked into vessel.When sample is being transferred to vessel, device can keep locating In compressive state.A part of entire vessel or vessel can be filled in sample.Whole samples (and/or sample from channel 90%, vessel can 95%, 97%, 98%, 99%, 99.5% or 99.9% or more) be transferred to.Alternatively, can only in the future Vessel are transferred to from a part of the sample in channel.

With reference to Fig. 9 C, the example of the device 900 in discrete state will now be described.Pedestal 940 can from device 900 its It is remaining to be partially separated.Main body 920 can be stretched or compressed relative to bracket 930.In one example, extended state can be nature State, so as to when user no longer to main body applied force when, main body is extensible to return to extended state.Channel 922a, 922b can consolidate Determine to main body.

When device 900 is in discrete state, pedestal 940 can be separated from the bracket 930 of device.Can by channel 922a, 922b is removed from the fluid communication of vessel 946a, 946b corresponding with them.It, can when device 900 is taken to discrete state First passage is taken away into the fluid communication with the inside of the first vessel, and second channel can be taken away in the second vessel The fluid communication in portion.This can occur in order or simultaneously.When channel is removed from vessel, seal shape can be presented in vessel State is to prevent undesirable material from entering the vessel.In some embodiments, vessel can be not after the removal in channel Leakage current body.Optionally, vessel can be air tight body after the removal in channel.

User can separate pedestal 940 with by device band to discrete state, to remove vessel therein from bracket 930. In some embodiments, pedestal can be separated from bracket, or vice versa.It can be exposed from bracket separation pedestal By vessel 946a, 946b of base supports.Vessel can be pressed in or otherwise be held in pedestal.Vessel 946a, 946b can be can be from pedestal removal.For lifting non-limiting example, removing vessel 946a, 946b allows itself and other devices Ware is placed on together in the shipping container of climate controlling, for transporting to reception site, such as, but not limited to analysis place. It is alternatively possible to remove vessel 946a, 946b to allow be forwarded in the reception for such as, but not limited to analyzing place Place is pre-processed before being handled, and is such as, but not limited to centrifugated.Alternatively, vessel 946a, 946b can keep with Pedestal is together.

Figure 10 A- Figure 10 B provides the additional views of the sample collection device 1000 in discrete state.When in separation When state, pedestal 1040 can be separated from the bracket 1030 and/or main body 1020 of device and (partially or even wholly be separated).This permits Perhaps vessel are removed by being previously not exposed to one end of outer pedestal 1040 when device 1000 is not at discrete state 1046a and 1046b.

When device is in discrete state, one or more channel 1022a, 1022b can with accommodated by pedestal 1040 one A or multiple vessel 1046a, 1046b fluid isolations.Vessel can completely cut off with their environment liquid.Vessel can include wherein Sample, which is transported by collection channel, reaches minimum fill level, and is then substantially completely stored to corresponding Vessel in.Pedestal 1040 may include one or more optical indicator 1046a, 1046b.The optical indicator can be shown A part of vessel therein, so that device 1000 is not moved to discrete state, until having reached minimum filling water in vessel It is flat.For lifting non-limiting example, vessel can have a light transmitting material, allow user except pedestal from vessel Sample.

In some embodiments, pedestal 1040 may include at least part of vessel.Pedestal can have hollow inside And surround the wall of the hollow interior.Pedestal can have one or more moulding features of sustainable vessel.Vessel can provide Within hollow interior.Wall can surround vessel.Pedestal can have open top, can expose vessel by the top. Vessel can by or can not be removed by the open top.

Collection device with multiple collection channels

With reference to Figure 11 A- Figure 11 F, further embodiment as described herein will now be described.The embodiment provides Body fluid sample collection device 1100 can come together in or to be otherwise formed into surface (such as, but not limited to tested for collecting The skin of person or other target areas) on fluid sample.Although this embodiment illustrates limit not co-content wherein At least two collection channels apparatus main body, it is to be understood that, however not excluded that the collection channel with less or more number Device.Also it is not excluded for using one or more channels the embodiment of identical trapped volume.For reality described herein Applying mode, there may be variations and substitution, and should not be construed to any single embodiment comprising entire invention.

Figure 11 A illustrates the perspective view of an embodiment of the body fluid sample collection device 1100 with distal end 1102, The distal end 1102 is configured for the fluid sample on engagement surface.In the present embodiment, distal end 1102, which can have, is set The configuration of a droplet or a beach body fluid or sample that meter is formed on surface for preferably engagement.In addition to desired shape it Outside, some embodiments can also have surface treatment at distal end 1102, and such as, but not limited to chemical treatment, texture, surface is special Sign or coating, to promote fluid towards one or more openings 1104 on distal end 1102, leading to the channel in device 1100 With 1106 flowings.

As seen in Figure 11 A, the present embodiment of sample collection device 1100 can have there are two opening 1104 and 1106, For receiving sample fluid.It should be appreciated that some embodiments can be open in far-end with more than two.Some embodiment party Formula can only have an opening in far-end.Optionally, some embodiments can be along the distal end for leading to separate device 1100 The side of 1102 places or other surfaces have additional opening.Opening 1104 and 1106 can have any cross-sectional shape.One In a little non-limiting examples, opening can have circle, ellipse, triangle, quadrangle (for example, square, rectangle, trapezoidal), Pentagon, hexagon, octagon or any other cross-sectional shape.Along the length of collection device main body, cross-sectional shape can To keep identical or can change.In some cases, opening can have less than or equal to about 2mm²、1.5mm²、1mm²、 0.8mm²、 0.5mm²、0.3mm²Or 0.1mm²Cross-sectional area.Some embodiments can have the opening of same shape.Other Embodiment can use different shapes for one or more openings.

Sample fill part 1120 can be the main body of sample collection device 1100, can be by transparent and/or translucent Material is formed, the material aloow one that user checks whether sample come into sample fill part 1120 or Multiple sample collection channels (referring to Figure 11 B).In some embodiments, entire sample fill part 1120 is transparent or half Transparent.Alternatively, some embodiments can only make all areas on channel or only channel or sample fill part 1120 Selected part be it is transparent or semitransparent, to allow filling of the visible sample of user into sample collection device 1100.It is optional Ground, sample fill part are made of opaque material, but have opening or window with allow to fill level therein can Depending on changing.Device 1100 can further comprise one or more visualization windows 1112 and 1114, to allow user to see when to reach Desired fill level is arrived.Visualization window can be formed by transparent and/or trnaslucent materials.Alternatively, visualization window can To be in the wherein not no opening of any material.The institute in collection channel can also be determined using additional visualization window There is fluid to be cleared in vessel 1146a and 1146b (referring to Figure 11 B).

Some embodiments that bracket 1130 is also shown in Figure 11 A can have optical window 1132 and 1134, the optical window It is positioned to show the fill level in vessel 1146a and 1146b, to whether to show vessel in pedestal 1140 It is moved on the position to receive sample fluid.Optionally, window 1132 and 1134 can be notch, serves as and is used for The guide rail of the snap features of pedestal, to limit initial position and end position during activation.It should be understood that pedestal It can be configured for keeping one or more sample vessel.For by way of example, and not limitation, entire pedestal 1140 can It is removed before or after sample filling from sample collection device.Pedestal 1140 can be used as retainer during transportation by sample Product vessel remain in wherein, and in such an embodiment, and pedestal 1140 will be loaded to together with sample vessel Transport pallet or in other retainers of transport.Alternatively, some embodiments can remove sample vessel from pedestal 1140, And vessel are then transported without keeping them with pedestal 1140.

Figure 11 B shows the cross-sectional view of the section line B-B along embodiment shown in Figure 11 C.Figure 11 B shows portion Divide the channel 1126 and 1128 in 1120.Sample fill part 1120 can be by being bound up with two of characterizing portion 1120 Or more part formed.Channel can be limited in a part and then have another part by some embodiments, should Another part is matched with the first part to limit the opposite wall in channel or top wall surface.For manufacture, this allows one zero Part the has a molding or channel that is otherwise formed into main body, and opposite part will cooperate it is described to serve as The covering in channel can also be including the part in the channel.Channel 1126 and 1128 can only be formed in part 1120 In, or be also extend in bracket 1130, the bracket 1130 have to be maintained in pedestal or carrier 1140 The feature that vessel are connected.Some embodiments can be such that part 1120 and part 1130 is formed integrally together.Bracket 1130 also can be configured for keep adaptor channel 1150, the adaptor channel 1150 will make channel 1126 and 1128 with Their corresponding vessel 1146a and 1146b are fluidly connected.

Although these embodiments of this paper are described as using two channels and two vessel, it is to be understood that, it does not arrange Channel and vessel except other numbers.Some embodiments can have channels more more than vessel, and some of channels will coupling It is bonded to same vessel.Some embodiments can have vessel more more than channel, and multiple vessel can in this case It is operatively coupled to same channel.

As seen in Figure 11 B, channel 1126 and 1128 can be different size.This allows to exist different fluid volumes It is collected in each channel before being transferred simultaneously into vessel 1146a and 1146b.Optionally, some embodiments can be with With the channel 1126 and 1128 for being sized to the fluid comprising same volume.In some embodiments, to channel 1126 and 1128 fluid passage moulding and/or keep it angled, so that the aperture efficiency proximal end near distal end 1102 is mutually more Add close, opening can be spaced farther apart from align them that for entering in vessel 1146a and 1146b.For this paper institute There may be variations and substitution for the embodiment of description, and should not be construed to any single embodiment comprising entire Invention.

Some embodiments, which are also shown, in Figure 11 B can be used main body 1130 of the needle for communicating with channel 1126 and 1128 In adaptor channel 1150 and 1152.The needle has channel respectively to allow fluid to wear from collection channel 1126 and 1128 Cross the end for wherein arriving at needle.As seen in Figure 11 B, vessel 1146a and 1146b in pedestal 1140 can be relative to brackets 1130 slidings, as indicated by arrow 1156.Relative motion between bracket 1130 and pedestal 1140 can reduce gap 1154.Contracting Small―gap suture 1154 by the cap 1148a of 1150 band of adaptor channel to vessel 1146a, until in vessel 1146a inside with Exist between collection channel 1126 and is in fluid communication.At this point, formal power will be then mobile by the fluid in channel 1126 Into vessel 1146a.

For by way of example, and not limitation, any combination of power can be used to suck sample into vessel. The pulling force of the vacuum in vessel 1146a can be used to suck sample into vessel in some embodiments.Some embodiment party Formula can be used the thrust from external pressure and fluid be moved in vessel.Some embodiments can use this simultaneously Two kinds of power.Some embodiments can be dependent on capillary force and/or gravity.In some embodiments, for being sucked into channel One or more power of sample are different from one or more power for sucking sample into vessel.In some alternative realities It applies in mode, one or more power can be each stage identical.In some embodiments, in order Or one or more power are applied with the period of restriction.For lifting non-limiting example, do not apply into vessel The one or more power for sucking sample, until at least one channel has reached minimum fill level.Optionally, do not apply use To suck one or more power of sample into vessel, until the minimum that at least two channels have respectively reached the channel is filled out Water-filling is flat.Optionally, one or more power to suck sample into vessel are not applied, until all channels are respective Reach the minimum fill level in the channel.In some embodiments, while applying one or more power.Enumerate these Feature can be adapted for any embodiment of this paper.

1E referring now to figure 1 shows the enlarged cross-sectional view of device 1100 in figure.The embodiment show brackets 1130 With flange portion 1136, which is sized to extend in adaptor channel 1150 and 1152 enough Amount, to prevent user from inserting a finger into gap 1154 and puncture finger on one of described needle.

In addition, present embodiment has at least two in sample collection device 1100 as shown in Figure 11 B and Figure 11 E Channel.This allows each of channel 1128 and 1126 to introduce different materials into sample.Lift non-limiting example and Speech, if sample is whole blood, a channel can introduce heparin into blood and another channel introduces ethylenediamine tetra-acetic acid (EDTA).These anti-coagulants not only prevent the too early blocking in channel during filling, but also into whole blood introduce anti-coagulants with Just it prepares to be transported in vessel 1146a and 1146b.Optionally, replacing other than anti-coagulants or as anti-coagulants Generation, one or more channels can also carry out plasma coating.Plasma coating can reduce humoral sample in the channel Flow resistance.Such coating can be applied by pattern, the pattern such as, but not limited to strip, ring-type or together with will be in the channel Other patterns of any other the one or more coating used.

Optionally, there are the anti-coagulants of sufficient amount in respective channel so that fluid only single pass through channel it Afterwards, sample fluid will include the anti-coagulants of aspiration level in sample fluid.In traditional blood bottle, blood sample Without anti-coagulants until it enters bottle, and once in the bottle, technical staff can generally tilt repeatedly, shake and/ Or agitation bottle, so that the anti-coagulants in bottle can mix.In the present embodiment, sample fluid will enter sample It include anti-coagulants before vessel, and it will be so without tilting repeatedly or stirring sample collection device.In the reality of this paper It applies in mode, once-through provides time enough and enters the foot of the additives such as the anti-coagulants in sample fluid Enough concentration.In one embodiment, the volume that the channel EDTA has is 54uL, the EDTA coated with 200mg/mL；Heparin The volume that has of channel be about 22uL, be coated with 250 units/mL heparin.In another embodiment, the channel EDTA has Some volumes are 70uL, the EDTA coated with 300mg/mL；The volume that the channel of heparin has is about 30uL, and is coated with 250 units/mL heparin.For lifting non-limiting example, channel of the volume from 50uL to 70uL can be coated with EDTA, model It encloses for the EDTA from about 200mg/mL to 300mg/mL.Optionally, channel of the volume from 70uL to 100uL can be coated with EDTA, In the range of the EDTA from about 300 mg/mL to 450mg/mL.Optionally, channel of the volume from 20uL to 30uL can be coated with Heparin, in the range of from 250 units/mL heparin.For example, material can be coating on the target surface up to small less than 1 When and the solution that is then dried overnight.For embodiments described herein, there may be variations and substitution, and do not answer It is construed to when by any single embodiment comprising entire invention.

With reference to Figure 11 G, further embodiment will now be described.The embodiment of Figure 11 G is shown in sample collection device At 1200 distal end 1202, two or more channels are merged into single channel by sample collection device 1200, rather than are directed to Each channel has an opening 1204.The embodiment of Figure 11 G, which is shown, is divided into multiple isolated channels in public passage Before, there are public passage parts.It is as follows to be described in Figure 11 I, it is alternatively possible to there are backflow preventer, such as But be not limited to the discharge orifice along isolated channel location, with reduce sample from channel filling out into one or more vessel A possibility that sucking sample to another channel from a channel during filling and/or extracting.

As seen in Figure 11 H, the use of such public channel can produce the upper number outside sample collection device 1200 The opening of reduction, this can make its alignment opening 1204 to engage humoral sample.It can also enter receipts in humoral sample by having The more multiple capillary pulled on the same channel of acquisition means, to increase for sucking body fluid sample into sample collection device 1200 The capillary force of product.

With reference to Figure 11 I, the cross-sectional view of the selected component of sample collection device will now be described.Figure 11 I shows sample collection Device can have there are two channel 1182 and 1184, and there is common portion 1186 to lead to the entrance opening on device in the channel.? In some embodiments, common portion 1186 is one of channel 1182 or 1184 in terms of size, shape and/or orientation Continue.Optionally, common portion 1186 and channel 1182,1184 or can be in fluid communication with common portion 1186 it is any its Size, shape and/or the orientation in any one of his channel are different from.Figure 11 I is shown in a non-limiting example In, may exist spoiler at the interface 1188 between channel 1182 and 1184.The interface 1188 can be configured for ensuring Flowing into all two channels, is filled up completely so that they will all reach.In one embodiment, interface 1188 have the size bigger than leading to the channel 1182 far from 1188 place of interface.Although being not excluded for other sizes, more Large-sized interface 1188 can ensure that sufficient flow will enter channel 1182, and the channel 1182 is in the present embodiment There is lesser diameter and reduced volume relative to channel 1184.For embodiments described herein, there may be changes Change and substitute, and any single embodiment should not be construed to comprising entire invention.

Figure 11 I is also shown there may be discharge orifice 1190 and 1192, and the discharge orifice can be used for preventing between channel Cross flow one, especially when sample to sample vessel transfer move when.In one embodiment, 1190 He of discharge orifice 1192 is always open.In another embodiment, discharge orifice 1190 and 1192 can be opened wide only in seclected time, described selected Time is such as, but not limited to after channel 1182 and 1184 is filled or is substantially filled with.Some embodiments can make Discharge orifice 1190 and 1192 is clogged with soluble material, until they are in contact with sample fluid.Optionally, some implementations Mode can be used slidably covering and cover one or more of discharge orifice 1190 and 1192, so that they only exist It is opened wide the selected time by user.In one embodiment, covering is linked to sample vessel, so as to move into Movement with the sample vessel of the fluid communication in channel will also open wide one or more discharge orifices 1190 and 1192, to reduce The risk of cross flow one between channel.Optionally, such as, but not limited to other anti-friendships such as valve, gate or plug can also be used Distributary motivation structure prevents the fluid between channel 1190 and 1192 from shifting.

Figure 11 I, which is also shown, may exist the anti-leak device 1194 being positioned on adapter 1150 and 1152.At this In embodiment, anti-leak device 1194 is frit, can slideably from wherein they prevent sample from adapter The first position let out in 1150 and 1152, which is moved to, delivers stream into sample vessel in wherein their permission adapters The second position of body.In a non-limiting example, anti-leak device 1194 is at it by sample vessel or receiving sample vessel Shell it is engaged when will slide.The movement of sample vessel or shell in the non-limiting example shows these elements Movement will also will lead to the movement of anti-leak device 1194.

With reference to Figure 11 J, the another embodiment of sample collection device 1160 will now be described.Sample collection device 1160 This embodiment illustrates the devices 1160 to have sample in-position 1204, which leads to device Multiple channels 1162 and 1164 in 1160.Although Figure 11 J show channel 1162 and 1164 can have different shape and/ Or size, but some embodiments can be configured to volume having the same and/or shape.It is also understood that sample enters position Setting 1204 can be on the surface of device 1160, and perhaps optionally it can be tip, nozzle, shaft end or from device The a part for other protrusions that 1160 main body extends.The protrusion can be in the main body of device in same plane and with Body parallel alignment, or optionally, can be at an angle of, so that the axis of the protrusion intersects with the plane with device 1160.

Figure 11 J further illustrate for some embodiments, there may be sample flow feature 1166 and 1168 with Desired side is sucked up or otherwise vector preferably sample.In some embodiments, feature 1166 and 1168 is to lead Rail operates the channel size (such as, but not limited to width or height) to be reduced at least on an axis, and thereby increases logical Cross the capillarity in the region of those sizes reduction.In a non-limiting example, the process in sample introduction passage In, these flow characteristics 1166 and 1168 can pass through the channel region being located near anti-cross flow one feature 1170 with secondary fluid stream Domain.In one embodiment, the size of flow characteristics 1166 and 1168 is set, mainly to be inhaled by capillarity when flowing When taking, preferentially improve the interior flowing on direction.In one case, export-oriented flowing is not based on capillary force, but is based on Vacuum pull (such as from the pulling force of adjacency channel), and these flow characteristics 1166 and 1168 of present embodiment not by It is configured to provide auxiliary under in those vacuum, non-capillary flox condition.Therefore, flow characteristics 1166 and 1168 is some And not all embodiments is configured for the flox condition at least one type but is not other certain one or more streams It is assisted under the conditions of dynamic.Optionally, some embodiments can be used in conjunction with other technologies individually or with guide rail (such as, but not limited to moulding feature, one or more hydrophobic materials, one or more water wetted materials or other technologies) tomorrow To desired orientation push/pull sample.

Figure 11 J is also shown in one or more embodiments of this paper, there are angled sidewall features 1167, This feature 1167 makes in cone ground or otherwise the cross-sectional area in channel narrow in a manner of collecting sample, so that The sample size in channel without being collected can be remained in minimize.Figure 11 J, which is also shown, may be present one or more positioning spies Sign 1169, on the position and orientation to help for component to be linked in restriction during manufacture together.

Figure 11 K shows the side view of the present embodiment of sample collection device 1160.The side view of device 1160 illustrates There are such embodiments: wherein there are one or more anti-cross flow one features 1170 and (such as, but not limited to discharges Hole), minimize the unexpected sample cross flowing between channel 1162 and 1164, especially when in respective channel In have reached it is particularly true when desired fill level.Due to the interruption that discharge orifice creates in fluid passage, prevent Cross flow one feature 1170 and 1172 can prevent cross flow one.Cross flow one problem itself, which appears most often in, works as retainer When vessel in 1140 are engaged and provide additional power to pull in vessel sample from channel.Such " pulling " effect Sample unintentionally should may be sucked into adjacency channel from a channel.In order to minimize cross flow one, with by sample from logical Road pull in into vessel associated power will fluid from discharge orifice rather than in adjacency channel pull, to make unexpected Sample mix minimize.

Figure 11 K is also shown in some embodiments of this paper, and existing may be adapted to different sample fill parts 1120 common portions 1130 and 1140 being used together.Different capillary fill parts 1120 can be used in some embodiments.One Such fill part can be used in a little embodiments: the fill part uses different types of capturing technology, such as but not Be limited to from vein haemospasia, artery evacuation blood collection to sample, or from the interior location or target site of subject extract its His sample.

1L referring now to figure 1 shows an embodiment of sample flow feature 1166 and 1168 in figure.With channel 1162 and 1164 and common inlet access 1165 near sample flow feature 1166 and 1168 sample collection part should Viewgraph of cross-section is shown in one embodiment, and the feature is nearby desired in place of sample introduction passage.Figure 11L also shows the channel for not co-content, it may be desirable to be positioned closer to entrance 1165 logical with large volume Road 1164, as seen in the asymmetric position of entrance 1165.In some embodiments it can also be seen that it is also an option that sample flow One or more positions of dynamic feature 1166 and 1168 are to control fill rate, the packing volume in sample collection device 1160 Deng.It should be appreciated that one or more features in described feature may be adapted to be used together with the other embodiments of this paper.

1M referring now to figure 1 shows the channel 1162 and 1164 with the anti-cross flow one feature of sample in figure.At one In embodiment, the anti-cross flow one of sample is characterized in the discharge orifice at least one surface in channel 1162 and 1164 1170 and 1172.In a non-limiting example, the anti-cross flow one feature of these samples is located at any sample in device Near flow characteristics 1166 and 1168.In one embodiment, these anti-cross flow one features are configured for preventing channel Between flowing.These anti-cross flow one features can be located near the maximum filling position in each channel, so that when described logical When road is at or approximately at its maximum sample capacity, anti-cross flow one feature 1170 and 1172 is positioned sample to prevent overfill Product lead to that processed sample enters and another channel and undesirably makes the sample from two channels in a channel It mixes.

Figure 11 N shows the perspective view of the sample collection device 1160 with sample pad indicator 1112 and 1114.? In one embodiment, these indicators 1112 and 1114 are the transparent parts of opening either device 1160, allow to observe At least part in one or more channels 1162 or 1164.When sample is at least one of indicator 1112 and 1114 It can be seen that when, prompt is provided a user then to take another action, such as, but not limited to sample in splice holder 1140 Vessel.In some embodiments, there is only a sample pad indicator, which is in two or more channels In sample the substituted index being sufficient filling with.In some embodiments, only when being indicated by indicator 1112 and 1114, Joined sample vessel can just be taken action to.In some embodiments, it is only indicated when by the only one in the indicator When, it can just take action to joined sample vessel.

1O, Figure 11 P and Figure 11 Q referring now to figure 1 show an embodiment party of the device 1160 in along Figure 11 J in figure Cross section on each position of formula.Figure 11 O shows the cross section of display sample flow feature 1166 and 1168.It is also shown Anti- cross flow one feature 1170 and 1172.Engagement features 1174 can also be provided part is combined together, To form device 160.

Figure 11 P show adaptor channel 1150 and 1152 is positioned to extend in sample channel 1162 and 1164 or Person is at least in fluid communication with it.Optionally, some embodiments can have more inner cavity adaptor channels 1150 or 1152.It is optional Ground, some embodiments can have multiple adaptor channels with each sample channel, wherein such additional channel can be with that This in parallel, at an angle to each other, each other wrap up or otherwise orient relative to each other.

Figure 11 Q is shown in some embodiments, and vessel holder 1140 can be at asymmetrically shape (in cross section In) or otherwise moulding, so that being only capable of in device 1160 with a directional reception retainer 1140.Work as expectation When sample is guided from some channel into selected channel, this may be to be especially desired to.If can be inserted with various orientations Enter retainer 1140, then the sample from a channel may be eventually located in the vessel of mistake.It is alternatively possible to use it His feature, alignment characteristics, slot, visual cues, texture clue etc., to promote the preferred orientation of sample vessel in a device.

Integrated Tissue penetrating component

With reference to Figure 11 R, the another embodiment of sample collection device will now be described.The sample collection device 1210 includes Similar to feature shown in Figure 11 G, difference is that it further includes installing to the tissue penetration component of sample collection device 1210 1212.Such as, but not limited to actuating mechanisms such as spring actua 1214 can be used and emit the tissue penetration component.Figure 11 R The actuating mechanism 1214 in stand-by state is shown, and it is shown can be and can be compressed to emit towards destination organization The spring of tissue penetration component 1212.Tissue penetration component 1212 can be housed within shell 1216 and (be shown in phantom).One In a embodiment, shell 1216 includes a part that can be stripped, pierce through, discharge or otherwise open, to allow Tissue penetration component 1212 leaves shell but also keeps its aseptic before the use of tissue penetration component 1212.Some In embodiment, which can be foil, cap, polymeric layer etc..For embodiments described herein, there may be changes Change and substitute, and any single embodiment should not be construed to comprising entire invention.

In one embodiment, 1212 path of tissue penetration component is controlled to " normal " along track simultaneously (that is, forward direction of tissue penetration component) and " orthogonal " (that is, perpendicular to main motion vector).Some embodiments are penetrating Deepest point (that is, reentry point) at can not have and hard stop or stop suddenly, the hard stop or stop being spontaneous suddenly The main reason of pain.Cushion, cam passages or other non-hard stop mechanisms can be used to prevent and dash forward in some embodiments The associated pain of the shock wave so stopped.Even if such shock wave successfully avoids collision injury in tissue penetration component It is in the case where nerve near mouth position and harmful, this is because shock wave can still swash even if avoiding direct contact Such nerve living.Optionally, some embodiments can have the tissue penetration component for following non-shake path, thick to prevent Rough wound channel (residual pain).This in some embodiments can by with tissue penetration component or and tissue penetration Tightened up tolerance is realized in any path of navigation that the associated pin of component is used together.When penetrating tissue, this can be with It is non-shake path.Optionally, this can be tissue penetration component and trembles in non-except tissue and when it is within tissue Dynamic path.This, which can be reduced, can lead to the mass motion of the tissue penetration component of residual pain, lasting wound and cicatrization and " shakes It shakes ".

Some embodiments can have controlled export-oriented speed with prevent slowly and delay wound closure and it is postoperative go out Blood.For lifting non-limiting example, the controlled export-oriented speed of tissue penetration component by such as, but not limited to cam or higher can rub The mechanical mechanisms such as material are wiped to control.

Some embodiments may also include bounce-proof mechanism to prevent that group may be recoiled to after initial wound generates The uncontrolled associated accident of tissue penetration component in knitting lancing again.Some embodiments of this paper can have and will connect It is combined " berth (the parking) " mechanism or locking mechanism for knitting penetrating component or its attachment, to prevent tissue penetration component In its reentering when contracting from tissue out or retracting any other desired distance.

Lancet stops at depth capacity in skin before it starts its motion outward and is back to its initial position Abruptness only is intrinsic problem in this design.When at the deepest point that lancet is in that it is penetrated, skin is applied maximum The power of amount.Driving mechanism simply rebounds from the end of device, just as ball rebounds from floor.At the end of its introversive movement The lancet to stop suddenly at point transmits shock wave into skin, so as to cause many algesiroreceptors near lancet Excitation, even if they are not impacted directly.This is substantially exaggerated spontaneous pain.

As previously mentioned, mechanical cam actuating can be used to replace simple spring-actuated formula tissue in some embodiments Penetrating component.Device with cam-actuated design can be such that " hard stop " of tissue penetration component minimizes.Cam mechanism is usual It is spring driven, and generally provides preferably guidance actuating.The track of tissue penetration component is via taking in cam Pin and be tightly controlled into the path of navigation by tissue penetration member retainer.Cam mechanism allows to have softer return Predetermined speed curve and clear speed control to tissue penetration component extroversion track.The mechanism also efficiently avoids When the mechanism reaches rebound of the lancet into skin when it moves terminating point.In addition, when emitting in air, lancet Mechanical oscillation (or shake/swing) of the path in whole both directions is reduced.Some embodiments of this paper may be used also Minimize any mechanical swing (for example, due to caused by uneven or coarse cam path) of driving mechanism, to prevent this The driving mechanism swing of sample is directly delivered in tissue due to its " diriven motion curve ".

Optionally, some embodiments can be used electronically actuated by electronically controlled driving mechanism.The technology uses The miniaturized electronic motor (for example, voice coil, solenoid) being coupled with very accurate position sensor, thus with accurately by Tissue penetration component is movable into and out skin by the movement of control and speed.After rapidly entering, device makes tissue penetration structure Part is decelerated to accurate, preset depth, so as to smoothly, non-jitter and relatively slowly return.This allows quick Wound closure simultaneously avoids long-term wound.Lancet is penetrated into skin when tissue penetration component advances using the device Required power is controlled.The strict control of tissue penetration member actuation " curve " has an advantage that reproducible painless adopt Blood, output is enough and consistent blood sample is for detecting.

For the site of puncture creation extracted for blood sample, it may be desirable to the hand in the non-dominant hand of patient Refer to and selects suitable site of puncture on (nameless or middle finger).Site of puncture can be located at the side of finger fingertip.In a non-limit In property example processed, it may be desirable to keep the selected finger that warm hand band abuts patient 15 seconds.Optionally, some embodiments can One or more fingers of warm patient are reached from 10 to 60 second.Other embodiments can warm finger up to longer time.It is such It is warm to will increase the blood flow for leading to target site.In order to prepare target site, it may be desirable to use alcohol wipe object or similar Detergent wipe the side tip or the surface of subject of selected finger, so that it is guaranteed that having wiped selected puncture portion Position.In some embodiments, it is expected that waiting until skin is completely dried.In general, not having to gauze or accelerating in finger tip air blowing It is dry.

It after having formed puncture, keeps finger downward, is lower than patient's waist, to allow blood flow.From finger root Finger is gently massaged to finger tip, until forming drop of blood.It is carefully filled and the blood pearl that tip by making device is touched on finger Blood collection device.Ensure that device is filled up completely.Once being filled with blood collection device, the hemorrhagic areas of finger is pressed On pad of cotion on desk.Blood sample is transferred in collection vessel.Bandage is placed on finger.It will be with sample Vessel are placed into the transport case in refrigerator.All supply are abandoned into biohazard sharp instrument vessel.All supply are only For disposable.

If not puncturing from first time and obtaining enough blood, blood collection device is carefully placed at desk table On face, it is ensured that device keeps horizontal.Bandage is placed on the finger being punctured.On different fingers on patient's the same hand Select suitable site of puncture.If having punctured the third finger first, new site of puncture is selected on middle finger, and on the contrary ?.The selected finger for making warm hand band abut patient is kept for 60 seconds.Optionally, some embodiments can be one of warm patient Or multiple fingers are reached from 30 to 90 second.This leads to the blood flow of finger by will increase.Use any sample collection of such as this paper The sample collection device of device etc can support the sufficient sample of capillary blood to carry out these technologies of blood collection Product are collected, in facility and/or the inspection of substandard laboratory for improving amendment (CLIA) certification through clinical labororatory It surveys.

With reference to Figure 11 S, the another embodiment of sample collection device 1220 will now be described.It in the present embodiment, can be with Tissue penetration component 1222 is angularly installed relative to sample collection device 1220.This angled configuration allows tissue Penetrating component creates wound on the position being aligned with one or more samples acquisition opening 1103 and 1105.Although standard Spring emission-type actuator is shown as the driving mechanism 1224 for tissue penetration component 1222, it is to be understood that, it can be with It substitutes spring transmitter or in combination uses cam and/or power drive system.It, can when driving mechanism 1224 is spring To compress the spring so that tissue penetration component 1222 is moved to transmitting position, and release spring is to be pierced into destination organization In.Figure 11 S shows the tissue penetration component 1222 on spare space.Although attached drawing is shown for driving mechanism 1224 spring, it is to be understood that, however not excluded that it can be cured suitable for transmitting tissue penetration component with being created with subject Close other driving mechanisms of wound.For embodiments described herein, there may be variations and substitution, and should not incite somebody to action Any single embodiment is construed to comprising entire invention.

Similar to for like that, shell 1226 can be formed in around tissue penetration component 1222 described in shell 1216. Although Figure 11 S shows two tissue penetration components 1222 being mounted on sample collection device, it is to be understood that, however not excluded that Device with more or less a tissue penetration components.For example, some embodiments can have installation to sample collection to fill Set 1220 only one tissue penetration component 1222.For embodiments described herein, there may be variations and substitution, and And any single embodiment should not be construed to comprising entire invention.

With reference to Figure 11 T, another embodiment of sample collection device 1230 will now be described.This embodiment illustrates groups It knits penetrating component 1232 to be contained in sample collection device 1230, and as seen in Figure 11 T, actually be received with sample The central axis of acquisition means is aligned.This is positioned to tissue penetration component 1232 for existing close to opening 1103 and 1105 Extend outwardly on the position of positioning place from sample collection device 1230 on sample collection device 1230.Of course it is not excluded having The device of more or less openings, and the embodiment of Figure 11 T is exemplary and non-limiting.Figure 11 T is shown In one embodiment of sample collection device, firing button 1234 is mountable on sample collection device 1230.Optionally, Some embodiments can have the front end 1236 of moulding, which plays the function of actuating button, wherein when that will organize to press When to front end 1236 up to certain depth and/or specified pressure, tissue penetration component will be activated.

Once transmitting, tissue penetration component 1232 are moved as indicated by arrow 1233.In some embodiments, Tissue penetration component 1232 is completely contained in front of actuation in sample collection device 1230.Some embodiments can have Visual detector 1235 on device 1230, will be from where separating device about tissue penetration component 1232 with help And substantially where will form wound user is given and instruct.

In this non-limiting example, whole device 1230 can be at only just opening before use device 1230 sterile In bag or packaging.In this way it is possible to keep aseptic condition before the use for tissue penetration component and collection device.This The external sterile bag or packaging of sample could be applicable to any other embodiment herein.Figure 11 L also shows the front end of moulding 1236 (being shown in phantom) may be integrally formed or can be separately attached to sample collection device 1230.Before such moulding End 1236 can provide suction with the pipette samples fluid into sample collection device 1230.Optionally, moulding front end 1236 can be used Increase next free sample penetration structure in stretching destination organization and/or being forced among moulding front end to apply pressure Part 1232 is formed by the sample flow scale of construction of wound.It should be appreciated that any embodiment of this paper may be adapted to before moulding End 1236.Optionally, moulding front end can have one or more selected hydrophobic regions, with towards one or more on front end A collecting zone guides sample fluid.Optionally, moulding front end can have one or more selected hydrophilic regions, with direction One or more collecting zones on front end guide sample fluid.

With reference to Figure 11 U, the another embodiment of sample collection device will now be described.Present embodiment is similar to Figure 11 T's Embodiment, difference be Figure 11 T embodiment is using multiple tissue penetration components 1242 rather than single organization penetrates structure Part such as lancet.In one embodiment, these tissue penetration components are that have to reduce compared to traditional lancet The micropin 1242 of diameter.Multiple micropins 1242 can be activated simultaneously for device 1240, and organizationally create multiple wound portions Position.The spacing of micropin 1242 can lead to more capillary loops and be pierced and have more channels to can be used for that blood is allowed to arrive Up to tissue surface.This also allows to penetrate profile compared to the lancet with sharp tip and tapered profiles more " side ".This Micropin 1242 can be enable to engage more capillary loops over a greater surface area without neural last to more densely packed assembling It is penetrated in the Geng Shen organized layer of the tip too deep.

With reference to Figure 11 V and Figure 11 W, the further embodiment of sample collection device will now be described.Institute in the drawings In the embodiment shown, sample collection device 1100 can be mounted to be at an angle of with application-specific wounds creation device 1250, this is specially Have with wound creation device 1250 and is configured for from the outwardly extending tissue penetration component 1252 of device 1250.Sample is received Acquisition means 1100 can be optionally configured to moulding front end 1236 (with and without to accommodate tissue penetration component 1252 opening), wound can be removably mountable to and create device 1250.Optionally, sample collection device 1100 can be with It is flat to install to device 1250.Optionally, may exist the notch of moulding on device 1250, keep sample for press-fit Collection device 1100.It should be understood that, however not excluded that for removedly installing the other technologies of sample collection device 1100.It collects Such decoupling that device and wound create device allows to create device using more complicated, may be non-disposable wound 1250, which can create wound that is more controlled, reducing pain and create experience.

Figure 11 W shows sample collection device 1100 and can substantially horizontally be aligned, about the gravity to sample collection Effect keeps neutral.It is not excluded for other installation configurations that device 1100 creates device 1250 to wound.

With reference to Figure 11 X to Figure 11 Z, the further embodiment of various sample collection devices will now be described.Figure 11 X is shown Sample collection device 1240, wherein moulding front end 1236 can be used with device 1240.The moulding front end 1236 is similar to above The moulding front end.Vacuum source 1270 can be used to assist sucking humoral sample into device 1240.Vacuum source 1270 The main body of device 1240 can be linked to and/or be linked to moulding front end 1236.It should be appreciated that being retouched in present disclosure Any embodiment stated may be adapted to be used together with the equal samples acquisition auxiliary device of such as, but not limited to vacuum source 1270.

Figure 11 Y shows the another embodiment of sample collection device.Present embodiment, which uses, to be had for collecting sample The pipetter system at the tip 1280 of fluid.The tip may include coaxial mounted tissue penetration component 1282.Optionally, Side dress or angled tissue penetration component 1284 is shown to create wound in target site.With tip 1280 Pipetter system applied vacuum from subject to pull sample fluid.Optionally, moulding front end 1236 can be with tip 1280 are used together, to assist skin stretch or tissue remodeling in target site.

Figure 11 Z show some embodiments can be used diaphragm 1291 connection actuating mechanism be used for create vacuum Draw blood sample.Such connection allows diaphragm to create vacuum in backhaul of the tissue penetration component 1292 from target site. In one embodiment, tissue penetration component 1292 is micropin.The actuating of tissue penetration component is as indicated by arrow 1294 Emit tissue penetration component 1292 like that, and on the return path due to being connected with the movement of tissue penetration component 1292 Diaphragm movement and create vacuum.One or more vessel 1296 can be coupled to accommodate as collected by device 1290 Fluid.Some embodiments can have only one vessel 1296.Some embodiments can have one group of vessel 1296.Some realities The mode of applying can have multiple groups vessel 1296.Some embodiments external can be installed on device 1290.Some embodiments can be interior Portion is installed in device 1290.For embodiments described herein, there may be variations and substitution, and should not incite somebody to action Any single embodiment is construed to comprising entire invention.

Vertical current goes out limiter

Figure 11 E also clearly shows that there are sleeves 1156 around adapter 1150 and 1152.Although only scheming Shown in 11A- Figure 11 F, it is to be understood that, the sleeve with or without discharge orifice can be configured for it is contemplated herein Any embodiment be used together.As seen in the embodiment of Figure 11 E, channel can be limited by needle.These sleeves 1156 prevent fluid sample from flowing out too early before vessel 1146a and 1146b engage needle from adaptor channel 1150 and 1152. Due to the small size of sample fluid collected, preventing from flowing too early reduces and transfer of the fluid from channel to vessel Associated fluid loss amount.In one embodiment, sleeve 1156 can be by providing impenetrable liquid but non-air proof Sleeve minimize fluid loss.If sleeve is air proof, the capillarity in channel may be hindered normal It plays a role.Optionally, discharge orifice can be positioned near the pedestal of needle, far from tip by some embodiments, so that sleeve It can include sample at the position far from discharge orifice.

Figure 11 F is shown in the exemplary embodiment, and sleeve 1156 is configured to the opening through the sleeve 1158.This provides the improved embodiment of the conventional sleeve compared to usual loose fit on needle.Due to loose fit, In conventional sleeve, there are sleeve volumes in the sidewall spaces in tip and between needle and sleeve, and fluid sample can Accumulation is in the inner.Although with may continuous loss fluid without sleeved needle compared with, the sleeve designed in this way can pass through by Loss is limited to limited amount to help prevent the greater loss of fluid, but accumulated in tip and the sleeve section of side wall Fluid is still lost, and not as collected by vessel 1146a or 1146b.Sleeve 1156 may also include narrowed areas 1176 To promote engagement of the sleeve to providing with the device of the fluid communication in channel 1126 and 1128, such as, but not limited to needle, probe, Pipe, channel or other adaptor channels 1150.

In the embodiment of Figure 11 F, based on calculate be arranged opening 1158 size, it is described calculating be enough to bear with The associated fluid pressure of the mobile phase of the capillarity in channel in sample fill part 1120.The power allows opening 1158 Air is discharged from channel at place, and also prevents fluid from leaving sleeve, until vessel 1146a and 1146b pushed with Engage adaptor channel 1150 and 1152.Due to the discharge effect that opening 1158 creates, sleeve lateral wall and other areas can be made Domain ratio closely much engages needle in conventional sleeve.This reduce the clearance spaces between needle and sleeve, and therefore with by In cooperation laxity and with much bigger clearance space do not have discharge hole sleeve compare, allow to lose Fluid Volume minimize.It is also possible to provide opening 1158 is sized such that be then open offer once fluid reaches opening Enough resistances are so that also stopped the outflow from channel or needle, so that any between sleeve and needle tip here Fluid loss in gap is minimum.

Calculating for openings of sizes to be arranged is as shown in Figure 12.Be contemplated to be each power of balance so that in the presence of with restriction The anti-leak power of the associated abundance of the hydrophobic material of discharge orifice, so as to the outflow comprising sample fluid except sleeve.Scheming In 12, the side wall of sleeve 1156 can directly be contacted with needle, or in some embodiments, can be deposited along the side wall of sleeve In gap.In one embodiment, sleeve 1156 include hydrophobic material, such as, but not limited to thermoplastic elastomer (TPE) (TPE), Butyl rubber, siloxanes or other hydrophobic materials.In one embodiment, the thickness of sleeve will also determine sleeve 1156 In opening or discharge orifice 1158 side wall length.

Opening 1158 can be located at the one or more positions along sleeve 1156.Some embodiments can be as in Figure 12 It is shown that there is opening like that.Alternatively, some embodiments can have the opening 1158 on the side wall of sleeve.It is not excluded for it His position.Optionally, sleeve 1156 can have multiple openings, and multiple opening runs through the sleeve, but is configured so that stream Body does not leave from sleeve and the resistance from opening is enough prevents additional outflow from channel, until vessel 1146a or 1146b and channel engagement and fluid communication.

For collecting sample, in a kind of technology, protect sample collection device 1100 on how to use device 1100 It holds engaged target body fluid and is held in place, until reaching desired fill level.During this period, it can horizontally protect Device 1100 is held so as to will may require that the gravity overcome is minimized in the case where being more held vertically throughout device 1100.Reaching After fill level, device 1100 can be disengaged from target fluid, and then engagement vessel 1146a and 1146b with to device The fluid being collected into is sucked in ware.It is alternatively possible to which retaining device 1100 is in contact with target fluid, and vessel are engaged It is contacted at channel fluid, so that filling will suck fluid in the channel and may be also sucked into and remain in target site Any additional sample fluid at place.This may insure to suck enough body fluid into vessel.

After being filled with vessel 1146a and 1146b, container can be prepared for shipping.It is alternatively possible to transporting They are sent to before and is pre-processed.Some embodiments of vessel 1146a and 1146b include one of vessel density Material so that in centrifuge separation etc. after pretreatments, the material will be made due to its selected density through from A part of the sample of heart separation is mutually separated with another part of the sample being centrifuged in same vessel.

Container 1146a or 1146b can have vacuum and/or negative pressure wherein.When channel is taken to and vacuum utensil fluid When connection, sample can be sucked into vessel.Optionally, vessel can take the form of examination tube, have by New Jersey The Becton-Dickinson Company of East Rutherford is with those of " Vacutainer " brand sales device Property.When sample is just transferred in vessel, device can be held in compression with and 1140 closing gap 1154 of pedestal. Sample can fill a part of entire vessel or vessel.From channel whole samples (and/or sample 90%, 95%, 97%, vessel can 98%, 99%, 99.5% or 99.9% or more) be transferred to.Alternatively, can be only by the sample from channel A part of product is transferred to vessel.

In an embodiment as described herein, two stages of the sample fluid into sample collection device 1100 Filling allow: i) metrics collection of sample fluid with ensure through handling with prevent premature set collection channel in obtain foot Enough amounts, and then ii) shifted into vessel high percentage sample fluid effective means.To into vessel 1146 It measures this of the sample fluid of minimum and a variety of advantages is provided to the low loss filling of vessel from pre-filled channel, especially It is particularly true when the sample fluid of small size is collected in reply.Channel pre-fill is charged to desired level to ensure in vessel There are enough volumes to carry out desired detection to sample fluid.

As described herein, the whole device including sample fill part 1120, bracket 1130 and pedestal 1140 is It is fully transparent or translucent, to allow the visualization to component therein.Optionally, sample fill part 1120, bracket 1130 and pedestal 1140 in only one be fully transparent or translucent.Optionally, only sample fill part 1120, bracket 1130 or the selected part of pedestal 1140 be transparent or semitransparent.User can then based on sample fluid filling progress and The engagement in channel of the sample vessel into sample fill part 1120 and more accurately determine when to execute each program.? Bubble during filling in collection channel may be visible, and if seeing bubble, and the adjustable sample of user is received The position of acquisition means 1100 is with preferably engaged target sample fluid, so that the air being sucked into channel be made to minimize.It is also It will allow the user to know that and when free or disengaging the parts such as pedestal or vessel holder 1140 when filling is complete.

It should be appreciated that other methods can be used to be held in non-horizontal angle (such as, but not limited to hang down in device Histogram formula is downward) in the case where prevent the sample flow outside from adaptor channel 1150 and 1152.In an embodiment In, frit 1194 can be used together with needle with a central hole, and the needle is used as adaptor channel 1150 and 1152.Frit can In main body to be located at sample collection device or on collection vessel.In some embodiments, frit includes such as, but not limited to The materials such as PTFE.Optionally, the needle in the function of playing adaptor channel 1150 and 1152 can be used in some embodiments On adhesive tape/adhesive.In one embodiment, adhesive tape and/or adhesive can be used to cover needle opening to prevent sample The too early discharge of product.Optionally, some embodiments can have such adaptor channel 1150 and 1152: it is with hydrophobic Surface is to prevent the controlled outflow being open from the adaptor channel for leading to sample vessel.In some embodiments, adapter Channel 1150 and 1152 is only on the inner surface of near exit with the needle of hydrophobic material.Optionally, hydrophobic material is only located at On the outer surface of the needle of near exit.Optionally, hydrophobic material is located in the inner surface and the outer surface of needle.Optionally, prevent to The another method of lower flowing is to increase the surface area of capillary by changing cross section.It is some for lifting non-limiting example Embodiment can introduce dentation or finger in capillary, the surface area in cross section to increase capillary.It is optional Ground, some embodiments may include the fin in capillary towards and/or backwards to fluid flowing, to increase the cross of capillary Surface area in section.For embodiments described herein, there may be variations and substitution, and should not be by any list A embodiment is construed to comprising entire invention.

Lead to a sample divider position in multiple channels

With reference to Figure 13 A- Figure 13 B, another embodiment as described herein will now be described.Figure 13 A, which is shown, has list One collects the top view of the sample fill part 1320 of position 1322, and the single collection position is such as, but not limited to two It meets so that fluid is collected the collection hole that position 1322 is sucked away from place from the simple sample in channel 1324 and 1326.Optionally, Y shape can be used to separate channel configuration for some embodiments, wherein only single channel lead to far from collecting in place of position 1322 and Then it is divided into channel 1324 and 1326 after having become the single public passage for leading to separate 1322 place of collection position.It mentions Feed to the component of the fluid communication in channel 1324 and 1326, such as, but not limited to needle, probe, pipe, channel, hollow elongate member Or other structures etc., it is coupled to one end of sample fill part 1320.

Figure 13 B shows sectional view, and collection position 1322 and itself is shown and channel 1326 is in fluid communication, And channel 1326 transfers to be in fluid communication with such as, but not limited to adaptor channels such as fluid communication component 1352.In some implementations In mode, fluid communication component can have enough rigidity and the tip sufficiently penetrated with puncture diaphragm, cap or vessel its His structure.Some embodiments can have the not coring structure such as adaptor channel 1352,1150, so as not to the diaphragm of vessel, The hole that will not be sealed is left in cap or other structures.

As seen in Figure 13 B, as indicated by drop D, sample fluid, which can be applied to or instill, to be collected in position 1322. Optionally, some embodiments, which can directly apply or directly contact, collects position 1322 to apply sample fluid.Although this paper's Embodiment is shown as that single collection position 1322 is used only, it should be understood that is also contemplated to plurality of channel and is coupled to The other embodiments of public sample collection point.For lifting non-limiting example, an embodiment of collection device can have Two collection positions 1322, each one group of channel with their own are led to far from place of its corresponding collection position.Some implementations Mode can separate in public bleeding point channel shown in Figure 13 A- Figure 13 B with shown in such as Figure 11 A- Figure 11 F logical Road combines.Public collection positional structure is not excluded for combine with other of the other structures with isolated channel.

It may include being configured for from collection position 1322 outwardly extending one that Figure 13 B, which also shows present embodiment, Or multiple tissue penetration components 1327.In one embodiment, this allows users to destination organization while being placed on receipts Collect position 1322 and wound is created on position for fluid sample collection.It is alternatively possible to which location trigger 1323 is to emit Tissue penetration component.Optionally, trigger is built in the tissue interface of device, in contact target tissue and/or The transmitting of device is supported in sufficient pressure or contact in place.This overlapping of the two positions allow that user is allowed to follow with Just the reduction procedure of successful acquisition sample.One or more tissue penetration components 1327 can be by one or more actuation technology institutes Actuating, the technology is such as, but not limited to spring-actuated, spring/cam-actuated, electronically actuated or above-mentioned every single or more A combination.It should be appreciated that such as, but not limited to other householder methods such as vacuum source, tissue stretching device, tissue junction nozzles are also It can be applied in combination individually or with any preceding method to improve sample acquisition.

With reference to Figure 13 C, the further embodiment of sample collection device will now be described.This embodiment illustrates cylinder caskets 1400, there is the sample collection device 1402 being fully integrated therein.It is opened in the presence of collection position 1322 and one or more samples Mouth 1325 and 1329 such as, but not limited to passes through pipettor point wherein sample collection can be accessed then at position 1322 Hold (not shown) processing.Sample from drop D will as indicated by the arrows, along access 1326 towards opening 1325 Hes 1329 advance, wherein being located in opening and leading to appointing in the access 1324 and/or 1326 of its corresponding opening 1325 and 1329 What sample is sucked into pipettor P.As indicated by the arrow near pipettor P, pipettor P is removable at least one axis It moves to support sample fluid to the transport of one or more desired locations.In the present embodiment, cylinder casket 1400 can have multiple For the receiving vessel 1410 of reagent, rinse fluid art, Mixed Zone, incubation region etc..Optionally, some realities of cylinder casket 1400 The mode of applying can not include any receiving vessel, or optionally, only include that a kind of or two classes accommodate vessel.Optionally, one In a little embodiments, accommodating vessel can be pipettor tip.Optionally, in some embodiments, accommodating vessel is in this way Pipettor tip: its handled on tip end surface (usually tip inner surface, but be not excluded for other surfaces) include one Kind or plurality of reagents.Optionally, some embodiments of cylinder casket 1400 can only include sample collection device 1402 without including group Penetrating component is knitted, or vice versa.

3D referring now to figure 1 shows the sectional view of the embodiment of Figure 13 C in figure.It is alternatively possible to include sample Penetrating component 1327 is for the wound use for creating the sample fluid for collect at position 1322.

Figure 14 shows sample fill part 1320 and can be linked with bracket 1330 and 1340 to form sample collection device 1300.There may be visualization windows 1312, to check whether sample fluid has reached desired fill level.It can be with Including the component that exerts a force, such as spring 1356 or rubber belt.Channel retainer can make channel remain fixed to bracket.In a reality It applies in mode, retainer can prevent channel relative to bracket slide.It can be used press-fit, mechanical fasteners, adhesive or its His attachment technology is to be coupled to channel.Retainer, which can optionally provide, can allow the force component such as spring to occupy thereon Bracket.

In one example, engagement assembly may include spring 1356, the spring can applied force so that when spring is in When its nature, pedestal 1340 is in extended state.It, can be in vessel 1346a, 1346b when pedestal is in its extended state Space is provided between assembly with engaging.In some cases, when pedestal 1340 is in its extended state, the second of channel End can contact or can not contact the cap of vessel.The second end of fluid communication component 1352 can be in they and vessel On the position that portion is not in fluid communication.

Bracket 1330 and pedestal 1340 are put together will be when component 1352 penetrates the cap on vessel by channel 1324 It is in fluid communication with 1326 bands to vessel 1346a and 1346b, and thereby sucks sample fluid into vessel 1346a and 1346b.

Vessel 1346a or 1346b can have vacuum and/or negative pressure wherein.When channel is taken to and vacuum utensil fluid When connection, sample can be sucked into vessel.Device is positively retained at compressive state, and pedestal 1340 is positioned such that work as sample When product fluid is being transferred to vessel, vessel and channel 1326 and 1328 are in fluid communication.Sample can be filled entire vessel or A part of vessel.From channel whole samples (and/or sample 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% or more) vessel can be transferred to.Alternatively, the only a part of the sample from channel can be transferred to vessel.

As seen in Figure 15, in an embodiment as described herein, sample fluid is to sample collection device Two stages in 1300, which fill, to be allowed: i) metrics collection of sample fluid is to ensure in the receipts for preventing premature set through handling Collection channel in obtain enough amounts, and then ii) shifted into vessel high percentage sample fluid effective means.With The low loss filling of vessel is provided from pre-filled channel with measuring this of sample fluid of minimum into vessel 1346 A variety of advantages, it is especially particularly true when the sample fluid of small size is collected in reply.Channel pre-fill is charged to desired level Ensure that there are enough volumes in vessel to carry out desired detection to sample fluid.

With reference to Figure 16 and Figure 17, further embodiment will now be described.Figure 16 shows blood collection device 1300, It is being collected around position 1322 with secondary collecting zone 1324.Secondary collecting zone 1324 can be used for it is by any spilling, Fluid sample spill or misguidance is guided towards position 1322 is collected.

Figure 17 further illustrates vessel 1346a and 1346b can be respectively with associated with vessel 1346a and 1346b Marker.Figure 17 shows in a non-limiting example, marker 1600 and 1602 can be at least one in the following terms : bar code (for example, 1-D, 2-D or 3-D), quick response (QR) code, image, shape, word, number, alpha-numeric string, Color or any combination thereof or any kind of visual cues object.Other embodiments can be used not in the visible spectrum Marker.Other embodiments can be used RFID label tag, RF marker, IR Luminous label, or independent of passing through Other markers of the mark of the signal sent through visible spectrum.

Marker 1600 and 1602 can be used for sample and/or sample type in identical samples collection device.Each device One or more markers may be present in ware.Some embodiments can also use marker on vessel holder.Marker can be with The component of the single vessel of one or more or device in identical samples collection device, device.In some cases, may be used To transport a part and/or vessel of sample collection device, sample collection device.In one example, it can be taken via delivering The part of sample collection device, sample collection device is transported in business or herein other any other described services everywhere.It can To deliver sample to execute one or more detections to sample.

Sample identity can be tracked and/or the identity of the individual of sample is provided.May include with provide one of sample or Multiple associated information of individual are (for example, name, contact details, Social Security Number, date of birth, insurance information, bill letter Breath, medical history) and sample supplier other information.In some cases, can track sample type (for example, whole blood, Blood plasma, urine etc.).The type (for example, anti-coagulants, marker etc.) for the reagent that sample will encounter can also be tracked.It is contemplated that About the additional information of sample collection, such as collection date and/or when time, sample collection locating environment, will to sample into Capable detection type, insurance information, medical record information or any other type information.

Marker can aid in the such information of tracking.Marker can be associated with such information.Such information can It is stored in except sample collection device, within sample collection device or any combination thereof.In some cases, the information can Be stored on one or more external device (ED)s, all for example servers of the external device (ED), computer, database or have storage Any other device of device.In some cases, the information can be stored in cloud computing infrastructure.Store up stored one A or multiple resources can be distributed on cloud.In some cases, point-to-point basis facility can be provided.The information can store Among marker itself, or can or any combination thereof associated with marker elsewhere.

Marker can provide unique identification, or a possibility that can provide high offer unique identification.In some cases Under, marker can have visible component.It is detectable that marker can be optics.In some cases, marker can be Visible light can be used to recognize.In some instances, marker can be bar code (for example, 1-D, 2-D or 3-D), fast Speed response (QR) code, image, shape, word, number, alpha-numeric string, color or any combination thereof are any kind of Visual cues object.

In other embodiments, marker, which can be, to carry out optical detection via the radiation of any other type.Example Such as, marker can be and can detect via the electromagnetism spectrum wavelength of infrared ray, ultraviolet light or any other type.Marker It can use luminous, such as light emitting of fluorescence, chemiluminescence, bioluminescence or any other type.In some cases, Marker can be transmitting set and/or receiver.Marker can be radio frequency identification (RFID) label.Marker can To be any kind of wireless transmitter and/or receiver.Marker can send one or more electric signals.In some feelings Under condition, GPS or other positions coherent signal can be used together with marker.

Marker may include audio component or acoustic assembly.Marker can make a sound, which can be distinguishable Know, to uniquely identify identified component.

Marker can be and can detect via optical detection apparatus.For example, barcode scanner can be read Marker.In another example, camera (for example, for static image or camera of video image) or other picture catchings dress The image of marker can be captured and analyze the image to determine mark by setting.

Figure 16 and Figure 17 shows according to embodiments described herein, be provided for and sample collection device The example of 1300 markers being used together.In one example, sample collection device may include pedestal 1340, the pedestal 1340 can support and/or include one or more vessel 1346a, 1346b.Sample can be provided to sample collection device.It can To provide sample to sample collection device via entrance 1322.Sample may continue to one or more vessel in device 1346a、1346b。

One or more markers 1600,1602 can be provided on sample collection device.In some embodiments, Marker can be positioned on the pedestal 1340 of sample collection device.Marker can be positioned at the side of the bottom surface of pedestal, pedestal In any other part of surface or pedestal.In one example, pedestal can have flat bottom surface.Marker can position In in the flat bottom surface of the pedestal.One or more recess can be provided in pedestal.Marker can be located at the recess It is interior.Recess can be located on bottom surface or the side surface of the pedestal.In some embodiments, pedestal may include one or more A protrusion.Marker can be located in the protrusion.In some cases, marker can be provided on the outer surface of pedestal.Mark Knowing object can be alternatively located on the inner surface of pedestal.It can be from sample collection device external detection marker.

In some embodiments, marker may be provided on vessel 1346a, 1346b.Marker can be located at vessel On outer surface or on the inner surface of vessel.Marker can be can be from vessel external detection.In some embodiments, Marker can be provided in the bottom surface of vessel.

In one example, pedestal may include light transmissive portion.The light transmissive portion can be located at pedestal bottom or On the side of pedestal.For example, transparent or semitransparent window can be provided.In another example, light transmissive portion, which can be, is not necessarily to The hole of window.Light transmissive portion allows partially visible in pedestal.Marker can be provided in light transmissive portion On the outer surface of pedestal, it is provided on the inner surface of pedestal but can be by light transmissive portion as it can be seen that being provided in vessel But it can be visible by light transmissive portion on outer surface or inner surface.In some cases, it can above be mentioned in the inner surface of vessel For marker, but vessel can be it is light transmissive, so as to observe marker by vessel and/or light transmissive portion.

Marker can be QR code or can be from other visible optical indicia of external optical of sample collection device Object.QR code can be visible by the optical window or hole of the bottom of the pedestal in sample collection device.QR code can provide In in a part on sample collection device pedestal or by the visible vessel of pedestal.The images such as camera or scanner Capture device can be provided in outside sample collection device, and can read QR code.

Single or multiple QR codes or other identifier object may be provided on sample collection device.In some cases, Mei Geqi Ware can have at least one marker, QR code such as associated there.It in one example, can be each in pedestal Vessel provide at least one window, and each window allows user to observe QR code or other identifier object.For example, two devices Ware 1346a, 1346b can be accommodated in pedestal 1340, wherein each vessel have and can recognize outside the sample collection device Associated marker 1600,1602.

Pedestal 1340 can be and can mutually separate with the other parts of bracket 1330 or sample collection device.One or more A marker can be separated together with pedestal from the rest part of sample collection device.

In some embodiments, marker can be provided with the vessel accommodated by pedestal.Pedestal and sample are received The rest part of acquisition means, which mutually separates, may cause to vessel and mutually separates with the rest part of sample collection device.Vessel can retain It can remove in pedestal or from pedestal.Even if removing vessel from pedestal, marker can be still retained in together with vessel.Or Person, even if vessel are removed, marker can be still retained in together with pedestal.In some cases, pedestal and vessel can have Marker, so that vessel and pedestal even still can individually be tracked and/or be matched in separation.

In some cases, any number of vessel can be provided in sample collection device.Sample vessel can Receive the sample from subject.Each sample vessel can have unique identification object.Unique identification object can be related to sample, by Any information of the component of examination person, device or device is associated.

In some cases, each marker of each vessel can be uniquely.In other embodiments, vessel On marker need not to be uniquely, but for device, can be uniquely for subject or for sample type.

Sample collection device can receive the sample from subject.Subject can directly contact sample collection device Or sample is provided to the device.Sample can march to one or more vessel in device by device.In some cases Under, it can be handled before sample reaches vessel.It can be can be by the sample collection unit of sample delivery to vessel And/or one or more coatings or substance are provided in channel.Alternatively, not to sample offer processing before sample reaches vessel. In some embodiments, it can handle in vessel or can not handle sample.In some cases, it is reached in sample Prior to or just when vessel, the processing of multiple and different types can be provided sample.It can be by pre-selected sequence offer processing.Example Such as, the first processing of expectation first, and it can be provided that in the upstream of second processing.In some cases, not at any point Manage sample.

In some embodiments, sample can be blood sample.First vessel can receive whole blood, and the second vessel It can receive blood plasma.Anti-coagulants can be provided along fluid path and/or in vessel.

Once providing sample to vessel and vessel being sealed, then vessel can be sent to individual place For sample analysis.The independent place can be laboratory.Independent place can be relative to the long-range of sample collection place Facility.Entire sample collection device can be sent to independent place.One or more markers may be provided in sample collection dress It sets, and can be used for identifying sample collection device and/or in vessel wherein.Alternatively, pedestal 1340 can be from sample collection Device removes, and can be sent to independent place with vessel therein.One or more markers may be provided on pedestal, and And it can be used for identifying pedestal and/or in vessel wherein.In some cases, vessel can be removed and can be sent from pedestal Toward independent place.One or more markers may be provided on each vessel, and can be used for identifying vessel.

Marker can be read by any suitable technology.For by way of example, and not limitation, in some feelings Under condition, marker is read using fluorescence detectors such as image capture device or barcode scanners.In an example In, image capture device can capture the image of QR code.The information about vessel can be tracked.For example, when vessel reach certain When one place, marker can be scanned, and the record of vessel arrival can be retained.It can actively and/or passively renovator The progress of ware and/or position.In some cases, it can be possible to need intentionally to scan position of the marker to determine vessel.? In other examples, marker can actively emit the signal that can be picked up by signal reader.For example, when marker is by building When object, signal reader can track the position of marker.

In some cases, reading marker can permit user's acquisition additional information associated with marker.Example Such as, certain device can be used to capture the image of marker in user.The device or another device can show about sample, Subject, device, device component information or other any other described information everywhere herein.It may include closing In the information of the detection and/or testing result to be carried out.User can be based on information associated with marker, to sample Execute subsequent detection or action.It is used to detect for example, user can guide vessel to appropriate location.In some cases, energy Vessel are guided to appropriate location in a manner of enough automations by without manual intervention and/or the content of vessel is carried out suitably Sample treatment (for example, sample preparation, measurement, detection, analysis).

Information About Sample Treatment can be collected and be associated to marker.For example, if vessel have marker, And sample treatment is performed to the content of vessel, then can store one generated in response to sample treatment or Multiple signals and/or it is associated with marker.Such update can be with the automation side without manual intervention Formula carries out.Alternatively, user can be with the storage of start information, or information can be manually entered.It therefore, can be with automation side Formula polymerize the medical records about subject.Marker can be used for indexing and/or accessing the information about subject.

Sample vessel

Figure 18 A- Figure 18 B is shown to be shown according to the non-limiting of sample vessel 1800 of embodiments described herein Example, the sample vessel 1800 can be used together with sample collection device.In some cases, sample vessel can be by sample collection Device is supported.Optionally, sample vessel by a part of sample collection device can include or surround.In an example In, sample collection device can have the first configuration, and wherein sample vessel are completely enclosed.The second configuration can be provided, wherein sample Product collection device can be unlimited, and can expose at least part of sample vessel.In some instances, sample Vessel can be supported by the retainer of sample collection device and/or at least partly by its closing.Retainer can be can be with What the rest part of sample collection device mutually separated, to provide the entrance to sample vessel therein.

In the case where body fluid sample collection, can be used such as, but not limited on September 6th, 2012 U.S. submitted it is special Sharp patent application serial numbers 61/697,797 and in the U.S. Patent Application Serial Number 61/798,873 that on March 15th, 2013 submits Described sample collection device extracts sample fluid from patient, and above-mentioned document is incorporated by by reference in this use In all purposes.In the non-limiting example of blood sample, some embodiments can be by collecting the hair from subject Thin blood vessel blood collects blood sample.This can by lead to the wound of the capillary blood from subject, piercing site or its The mode of his entry site and occur.Optionally, also blood can be collected by venipuncture or other vascular punctures, to obtain The blood sample in one or more sample vessel must be used to be loaded into.For example, can be by being configured to venipuncture The device of the blood collection of small size is carried out to collect blood.Such device for example may include and have smaller internal appearance Long-pending vessel fluidly connect or can be fluidly connected hollow needle.The vessel with smaller internal capacity can have Such as be equal to or be no more than 5ml, 4ml, 3ml, 2ml, 1ml, 750l, 500l, 400l, 300l, 200l, 100l, 90l, 80l, The internal capacity of 70l, 60l, 50l, 40l, 30l, 20l, 10l or 5l.It is not excluded for the other kinds of device for collecting body fluid And technology.

Draw body fluid and device can be provided it to from subject in several ways, the mode includes but not It is limited to: fingerstick, incision, injection, suction, wiping, liquid relief, vein haemospasia, venipuncture and/or other each places this paper Any other technology of description.In some embodiments, sample can be collected from the breathing of subject.Humor collecting can be used Device provides body fluid.Humoral collector may include lancet, capillary, pipe, pipettor, syringe, needle, micropin, pump or this paper Other any other described collectors everywhere.In some embodiments, sample can be the group that can be provided from subject Tissue samples.Sample, which can be removed or be can be from subject, have been abandoned by subject.

In one embodiment, the skin of lancet pierces subject and for example using gravity, capillarity, absorption, Pressure difference or vacuum power extract sample.Lancet or any other humoral collector can be the cylinder casket of a part of device, device A part, a part of system or stand-alone assembly.It when needed, can be by a variety of mechanical, electrical, electromechanical or appoint Any combination of what other known enabling mechanism or such method enables lancet or any other humoral collector.

In one example, the finger (or other positions of subject's body) of subject can be punctured to obtain body fluid.Body Capillary, pipettor, swab, drops or any other mechanism known in the art can be used to collect for liquid.Capillary or liquid relief Device can mutually be separated with the cylinder casket of device and/or device, or can be a part of device and/or cylinder casket, the cylinder casket It can be plugged into device or be attached to device.In another embodiment for not needing enabling mechanism, subject can simply to Device and/or cylinder casket provide body fluid, for example, providing body fluid with saliva sample.

From subject's draw body fluid and device can be provided it in several ways, the mode includes but unlimited In: fingerstick, incision, injection and/or liquid relief.Intravenous methods or non-vein method can be used to collect body fluid.Body fluid can be used Collector provides body fluid.Humoral collector may include lancet, capillary, pipe, pipettor, syringe, vein haemospasia device or Other any other described collectors everywhere herein.In one embodiment, lancet pierces skin and for example using Gravity, capillarity, absorption or vacuum power extract sample.Lancet can be a part of device, one of cylinder casket of device Point, a part of system or stand-alone assembly.When needed, can by it is a variety of it is mechanical, electrical, it is electromechanical or any other Any combination of known enabling mechanism or such method enables lancet.In one example, the hand of subject can be punctured Refer to (or other positions of subject's body) to obtain body fluid.The example at other positions of subject's body may include but unlimited In: hand, wrist, arm, trunk, leg, foot or the neck of subject.Capillary, pipettor or known in the art can be used in body fluid Any other mechanism collect.Capillary or pipettor can mutually be separated with device and/or cylinder casket, or can be device And/or a part of cylinder casket.In another embodiment for not needing enabling mechanism, subject can simply to device and/or Cylinder casket provides body fluid, for example, can be provided with saliva sample.The body fluid of collection can be placed in device.Humoral collector can It is attached to device, device is removably attachable to or can be provided separately with device.

It can be stored in sample vessel 1800 from the sample that subject obtains.In an embodiment described herein In, sample vessel 1800 include main body 1810 and cap 1820.In some cases, at least multiple portions of sample vessel body It can be formed by transparent or semitransparent material.Sample vessel body allow the sample being provided in sample vessel body from It is visible when being observed except sample vessel.Sample vessel body can be light transmissive.Sample vessel body can be by allowing electricity The material that magnetic radiation passes through is formed.In some cases, sample vessel body can be by the electromagnetic radiation of permissible selected wavelength It is formed across the material without allowing the electromagnetic radiation of other non-selected wavelengths to pass through.In some cases, one of main body Divide or entire main body can be formed by selected wavelength (wavelength of such as visible light) opaque material along electromagnetic radiation. It is alternatively possible to which some parts of moulding sample vessel body are to provide certain optical path length.It is alternatively possible to moulding sample The some parts of product vessel body are allowed with providing flat surfaces (outer surface and/or inner surface) or other structures in sample It is analyzed it while in sample vessel.

In one embodiment, open end and closed end can be provided in sample vessel body 1810.It open end can To be the top 1812 of sample vessel 1800, the one end that can be configured for engaging with cap may be at.Closed end can be with It is the bottom end 1814 of sample vessel, can be at one end of the sample vessel opposite with cap.In the alternative, bottom end It is also possible to the open end that bottom plate can be used to close.In some embodiments, the cross-sectional area and/or shape on top and bottom end Shape can be substantially the same.Alternatively, the cross-sectional area on top can be greater than the cross-sectional area of bottom end, or vice versa.For There may be variations and substitution for embodiments described herein, and should not be construed to wrap by any single embodiment Containing entire invention.

In one embodiment, sample vessel body can have the inner surface and the outer surface.The surface of sample vessel body Can be it is smooth, coarse, textured, having facet, glittering, dark, comprising groove, comprising convex ridge or tool There is any other feature.The surface of sample vessel body be can handle to provide desired optical property.Inner surface and appearance It face can property having the same or can be different.For example, outer surface can be smooth and inner surface is coarse.

Optionally, sample vessel body can have the shape of tubulose.In some cases, sample vessel body can have Cylindrical part.In some cases, sample vessel can have circular cross-sectional shape.Appoint alternatively, sample vessel can have What his cross-sectional shape, the shape may include ellipse, triangle, quadrangle (for example, square, rectangle, ladder Shape, parallelogram), pentagon, hexagon, heptagon, octagon or any other shape.The cross section shape of sample vessel Shape can have or can not have convex and/or spill.The cross-sectional shape of sample vessel can be along sample vessel Length keeps identical, or can change.Sample vessel can have prism shape along the length of main body.Prism can have as Cross-sectional shape described herein.

Optionally, the bottom 1814 of sample vessel can be flat, taper, it is mellow and full or any combination thereof.One In a little situations, sample vessel can have domed bottom.In other embodiments, sample vessel can have with flat part The mellow and full bottom divided.Sample vessel can or can can not be erected on the flat surfaces of its own.

In one embodiment, sample vessel 1800 may be sized to comprising small fluid sample.In some implementations In mode, sample vessel can be configured for comprising no more than about 5ml, 4ml, 3ml, 2ml, 1.5mL, 1mL, 900uL, 800uL、700 uL、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, 5pL or 1pL.For lifting non-limiting example, sample Product vessel can have information memory cell on it, such as be discussed for Figure 18 F and Figure 18 G.It is non-limiting at one In example, sample vessel 100 can accommodate the sample fluid of the small size of liquid form, without the use of wick material, sieve, solid Matrix etc. to accommodate sample fluid during transportation.This allows substantially to remove sample flow from sample vessel in liquid form Body, without the loss due to liquid sample or sample integrity caused by wick material or other materials absorption.

Optionally, sample vessel 1800 can be configured for comprising bleeding liquid no more than several liquid of bleeding, one, or not It bleeds more than one a part of liquid.For example, sample vessel, which can have, is configured for the fluid sample amount for including no more than it Internal capacity.With small volume sample vessel can advantageously allow for storage in small size to a large amount of sample vessel and/or Transport.This can reduce the resource for storing and/or transporting sample vessel.For example, it may be desirable to less memory space.This Outside, less cost and/or fuel can be used to transport sample vessel.For same amount of effort, can transport most Purpose sample vessel.

In some embodiments, sample vessel 1800 can have small length.For example, sample vessel length can be little In 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm, 1.1cm, 1cm, 0.9 cm、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 some cases, sample vessel full-size (for example, Length, width or diameter) can no more 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.

Sample vessel 1800 can have any cross-sectional area.Cross-sectional area can be not greater than about 16cm²、8cm²、7cm²、 6cm²、5cm²、4cm²、3.5cm²、3cm²、2.5 cm²、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.Along the length of sample vessel, cross-sectional area can keep identical or can change.

Sample vessel 1800 can have any thickness.Thickness can keep identical or can along the length of sample vessel With variation.In some cases, thickness can be chosen so as to and/or person can change in order to provide desired optical property.One In a little situations, thickness can no more than 5mm, 3mm, 2mm, 1mm, 700um, 500um, 300um, 200um, 150um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 3um, 1um, 700nm, 500nm, 300nm or 100nm.

In one embodiment, sample vessel 1800 can have the centrifugation point for being conducive to support small size blood sample From shape.This permission directly brings the collected sample in sample vessel to centrifuge, without further by sample fluid It is transferred to another sample vessel used in centrifuge apparatus.

Optionally, sample vessel may include cap 1820.Cap 1820 can be configured for the open end for being matched with sample vessel On.Cap can block the open end of sample vessel.Cap can be with Fluid Sealing sample vessel.Cap can be with sample vessel body shape At fluid-tight sealing.For example, cap can be airtight body and/or impenetrable liquid.Alternatively, cap allows certain gases And/or liquid passes through.In some cases, cap can be ventilative and impenetrable liquid.Cap can be sample impermeable 's.For example, cap whole blood, serum or blood plasma can be it is impermeable.

Optionally, cap can be configured for engaging with sample vessel body in any way.For example, cap can be with sample Vessel body press-fit.Frictional fit and/or interference fit allow cap to rest in main body.In other examples, Ke Yiti For locking mechanism, such as sliding equipment, fixture, fastener or other technologies.In some cases, cap and/or sample vessel Main body can be with screw thread to allow screw to engage.In other examples, adhesive, welding, soft soldering, hard solder be can use Cap is connected to sample vessel body.Cap can be removably attachable to sample vessel body.Alternatively, cap can permanently be consolidated Determine to sample vessel body.

In some cases, a part of cap can be engaged in a part of sample vessel body.Cap can be with sample vessel Main body forms plug.In some cases, a part of sample vessel body can be engaged in a part of cap.Plug can be with Including flange or shelf on a part of sample vessel body can be shrouded.Flange or shelf can prevent cap from sliding into sample In vessel body.In some cases, a part of cap can overlay on the top and/or side of sample vessel body.It is optional Ground, some embodiments may include the additional component in vessel assembly, such as cap retainer.In one embodiment, cap The purposes of retainer is the tight seal maintained between cap and sample vessel.In one embodiment, cap retainer engages Attachment, flange, recess or other attachment locations on sample vessel outside, to retain the cap in appropriate location.It is optional The function of cap and cap retainer can be combined in a component by ground, some embodiments simultaneously.

In some embodiments, sample vessel body can be formed by rigid material.For example, sample vessel body can be by The polymer such as polypropylene, polystyrene or acrylic compounds are formed.In the alternative, sample vessel body can be with It is semirigid or flexible.Sample vessel body can be formed by single single piece.Alternatively, multiple parts can be used.Institute Stating multiple parts can form by identical material or by different materials.

Optionally, sample vessel cap can by elastomeric material or herein other described any other materials everywhere It is formed.In some cases, cap by rubber, polymer or can be flexible and/or compressible any other materials It is formed.Alternatively, cap can be it is semirigid or rigid.Sample vessel cap can be formed by high friction material.Sample vessel cap Can frictional fit to be engaged with sample vessel body.It, can when sample vessel cap is engaged with sample vessel body Form fluid-tight sealing.It the inside of sample vessel body can be with surrounding air fluid isolation.In some cases, cap And/or at least one of part of sample vessel body for contacting the cap can be formed by height friction and/or compressible material.

In some embodiments, cap 1820 can be needle in the sealing engagement in the open end of sample vessel and/or The transparent self-sealed air tight closure of casing, to keep the vacuum and/or closed atmosphere in sample vessel.Some In embodiment, the inside of sample vessel only exists in partial vacuum rather than perfect vacuum.Excessive vacuum may be damaged The blood constitutent of formation in sample fluid.For lifting non-limiting example, the range of partial vacuum is the pact of perfect vacuum 50% to 60%.Optionally, partial vacuum is no more than about the 60% of perfect vacuum.Optionally, partial vacuum is no more than completely true Empty about 50%.Optionally, partial vacuum is no more than about the 40% of perfect vacuum.For lifting non-limiting example, part is true Empty range is about the 10% to about 90% of perfect vacuum, either between about 20% to about the 70% of perfect vacuum or about Between 30% to 60%.For lifting non-limiting example, the range of partial vacuum is about the 10% to about 60% of perfect vacuum, Either between about 20% to about the 50% of perfect vacuum or between about 30% to 50%.In this way, to body fluid sample Product apply the power of reduction amount so that minimizing about the problem of sample integrity.Optionally, described after sample transfer Atmosphere is under environmental stress.Optionally, after sample transfer, the atmosphere is under a certain partial vacuum.Optionally, Only one sample vessel in multiple sample vessel are under partial vacuum, and other sample vessel be in more condition of high vacuum degree or In perfect vacuum.

In some embodiments, cap 1820 can be one end inside sample vessel and the other end is outside sample vessel The closing device in portion, wherein inside end has the surface contacted with sample vessel lasting seals, which has from surface court To closed end extend annulus, the annulus have across the annulus wall extend and with sample vessel juxtaposition The first notch.In one embodiment, which has the recess ring that the first notch around inside end is formed, and The protuberance of saw-tooth ring engagement tubulose sample device ware.

Optionally, sample vessel cap can be formed by single single piece.Alternatively, multiple parts can be used.The multiple zero Part can be formed by identical material or by different materials.Cap material can be identical or different with sample vessel material of main part.At one In example, sample vessel body can be formed by light transmitting material, and cap is formed by opaque material.

Optionally, cap 1820 can be engaged removedly with main body.A part of cap, which can be, to be inserted into main body 's.Cap may include flange, which can be located at the top of main body.Flange is not inserted into main body.In the non-limiting example In, flange can prevent cap to be entirely inserted into main body.Flange can form continuous flange around cap.In some cases, flange A part can be overlapped in or overlay in a part of main body.A part of main body, which can be, to be inserted into a part of cap 's.

It is alternatively possible to be that the part of the cap being inserted into main body can have mellow and full bottom.Alternatively, institute State part can be flat, taper, it is curved, wavy, or have any other shape.The shape of cap can be set It is set to and is easily inserted into main body.

In some cases, pit can be provided at the top of cap.The pit can follow the portion for the cap being inserted into main body Point.In some cases, hollow or pit can be provided in cap.Pit can receive to can be used for delivering to sample vessel The a part in the channel of sample.Pit, which can aid in, guides in channel to the expectations section of cap.In one example, will lead to The inside of road and sample vessel is brought can be by channel location in pit to before being in fluid communication.

It is alternatively possible to channel and cap are forced together, so that channel penetrates cap and enters the inside of sample device ware, To bring the inside in channel and sample vessel to fluid communication.In some cases, cap can have slit, and channel passes through should Slit.Alternatively, the demolished continual cap material in channel.Channel can be withdrawn from from sample vessel, thus by channel and sample device Ware takes away fluid communication.Cap can be resealed when channel is removed.For the example, cap can be by self- recoverage material It is formed.In some cases, cap can have slit, the slit can the closing when channel is removed, to be formed fluid-tight Sealing.

In some embodiments, main body may include one or more flanges or other surfaces feature.Surface characteristics is shown Example may include flange, bulge, protrusion, groove, convex ridge, screw thread, hole, facet or any other surface characteristics.Flange and/ Or other surfaces feature can circumscribed main body.Flange and/or other surfaces feature can be located on or near the top of main body.Flange And/or other surfaces feature can be located at main body top half at, at the one third of top, at a quarter of top, top At portion 1/5th, at top 1/6th, at top 1/8th or at top 1/10th.Surface characteristics can be used for sample Support of the product vessel in sample collection device.Surface characteristics can be used for from sample collection device remove sample vessel and/or Sample device ware is positioned in sample collection device.Flange and/or other surfaces feature can engage with cap or can not be therewith Engagement.

Optionally, cap can have any size relative to sample vessel body.In some cases, cap and/or main body There can be similar cross-sectional area.Cap can have identical with the top of main body or substantially similar cross-sectional area and/or shape Shape.In some cases, cap can have the length smaller than main body.For example, cap can have be smaller than principal length 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3% or 1% length.

8C to Figure 18 E referring now to figure 1, the further embodiment of sample vessel 1800 may include cap retainer 1830, should The cooperation of cap retainer 1830 is on cap cap to be secured in position.For lifting non-limiting example, cap retainer 1830 may also include Opening in cap retainer 1830, the opening allow the member slides such as adapter to pass through and penetrate cap 1820. Figure 18 C shows the component with exploded view.

Figure 18 D shows sectional view, which illustrates an embodiment, and wherein sample vessel body 1810 has The cap 1820 covered by cap retainer 1830.As seen in Figure 18 D, there is cap retainer 1830 lock-in feature 1832 to be used for Cap retainer 1830 is fastened to sample vessel body 1810 and/or cap 1820.In one embodiment, lock-in feature 1832 include inner ridge, the inner ridge will in the convex ridge 1812 and 1814 in joined sample vessel body 1810 one It is a or multiple.Figure 18 E shows the side view for being coupled to the cap retainer 1830 of sample vessel body 1810.

In some cases, the surface (inner surface and/or outer surface) of sample vessel can be coated or handled with material. For example, can be with fixative, antibody, optical coating, anti-coagulants, sample additive and/or preservative come coated sample vessel Inner surface.These can be identical or different with any material coating in channel.In a non-limiting example, coating can be with It is but not limited to: polytetrafluoroethylene (PTFE), polyxylene, polysorbate surfactant (such as polysorbate 20) or other materials, As the processing to surface to reduce surface tension.

In embodiments, sample vessel may include blood clotting activator (for example, fibrin ferment, silica dioxide granule, Glass particle), anti-sugar solution agent (for example, sodium fluoride) or gel to be to promote the separation of haemocyte and blood plasma.In this example, sample Vessel may include poly- trans-anethole sodium sulfonate (SPS), acid citrate dextrose additive, perchloric acid or sodium citrate.It is some Embodiment may include the material of at least one each grouping in the above grouping.Optionally, it is also understood that do not arrange It is especially particularly true in the case where additive is not interfere with each other functionally except other additives or material.

Optionally, coating is applied on all inner surfaces of sample vessel.Optionally, some embodiments can be by Cover the pattern of the selection area in sample vessel only to apply coating.Some embodiments can only cover sample vessel Upper interior zone.Optionally, some embodiments can only cover interior zone under sample vessel.Optionally, some implementations Mode can cover the item, line or other geometrical patterns of the interior zone of sample vessel.Optionally, some embodiments can also apply The surface of overcap, plug, or the covering that coating is used together with sample vessel.Some embodiments can be with coated sample From there into the surface of sample vessel, to provide to the separate entrance region of sample and towards destination (such as, but not limited to The bottom part of vessel) smooth transfer.

Optionally, coating can be wet coating or dry coating.Some embodiments can have at least one dry coating and extremely A few wet coating.In some cases, one or more reagents can be coated and be dried on the inner surface of sample vessel.It applies Layer can alternatively be provided in moist environment or can be gel.Some embodiments may include in sample vessel Separating gel, to keep the selected part of sample far from the other parts of the sample.Some embodiments may include serum point From gel and blood plasma separating gel, separation can such as, but not limited to buy from Becton Dickinson, based on polyester is solidifying Glue.

It is alternatively possible to provide one or more solid matrixs in sample vessel.For example, can be in sample vessel One or more beads or particle are provided.Bead and/or particle can be coated with reagent or any other object described herein Matter.Bead and/or particle can dissolve in the presence of sample.Bead and/or particle can be by one or more examinations Dosage form at, or can help to processing sample.Reagent can be provided in a gaseous form in sample vessel.Sample vessel can be with It is sealing.Before introducing the sample into sample vessel, after having introduced the sample into sample vessel and/or While introducing the sample into sample vessel, sample vessel can keep sealing person.In one embodiment, sample device Ware can have smooth surface and/or rounded bottom.This helps so as to the stress of blood sample minimum, especially from The heart is particularly true during separating.Certainly, in the alternative, however not excluded that the other shapes of the bottom of sample vessel.

In embodiments, the humoral sample in sealed sample vessel can retain dissolved gas in humoral sample, so that The sample that must be stored in sealed sample vessel retains from the humoral sample that the body from subject newly extracts or from different samples The similar or identical dissolved gas composition of the freshly prepd sample of product (for example, the freshly prepd blood plasma from whole blood).In embodiment party In formula, through 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, it is 16 small When, 24 hours, periods of 48 hours or 72 hours, the humoral sample in sealed sample vessel can retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% dissolved gas.In general, in such reality It applies in mode, the period started from time that sample is placed into sample vessel or the time for sealing sample vessel.For Promote to the reservation of dissolved gas in humoral sample, it can be in the selected temperature such as such as 20 DEG C, 15 DEG C, 10 DEG C, 4 DEG C Under, or under the cryogenic temperature lower than 0 DEG C, sample is stored in the sample vessel of sealing.Other are not excluded for for sample The temperature of storage.

Similarly, in embodiments, the humoral sample in sealed sample vessel can retain the analysis in humoral sample Object, so that the sample being stored in sealed sample vessel retains the humoral sample newly extracted with the body from subject or new The similar or identical analyte composition of the humoral sample (for example, the freshly prepd blood plasma from whole blood) of preparation.In embodiment In, through 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, it is 16 small When, 24 hours or 48 hours period, the humoral sample in sealed sample vessel can retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% analyte.In general, in such an embodiment, institute Stating the period started from time that sample is stored in sample vessel or the time for sealing sample vessel.In order to promote in body To the reservation of one or more analytes in liquid sample, it can be in the selected temperature such as such as 20 DEG C, 15 DEG C, 10 DEG C, 4 DEG C Under, or under the cryogenic temperature lower than 0 DEG C, sample is stored in the sample vessel of sealing.Other are not excluded for for sample The temperature of storage.Optionally, sample vessel can be centrifuged later in introducing the sample into vessel.For example, can be Sample is introduced into 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 in vessel To sample in minute, 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 Product vessel are centrifuged.For example, carrying out centrifugation to packet sample vessel with sample can promote blood in the case where whole blood sample The separation of cell and blood plasma, to obtain the cell of blood plasma and precipitating.In some cases, centrifugation is carried out to sample and improves blood The stability of one of liquid or blood plasma or multiple analytes.

Figure 18 F, which further illustrates sample vessel, respectively to have at least one information for being associated with the sample vessel to deposit Storage unit.Optionally, some embodiments can make an information memory cell transmit the information about multiple sample vessel, special It is not in the case where (but being not limited only to) sample vessel all include from the sample of same subject.Such information is deposited Storage unit can be located on the carrier for keeping multiple sample vessel, rather than be located on sample vessel itself.

Figure 18 F shows the bottom view of the bottom surface of one of described sample vessel, in a non-limiting example, letter Ceasing storage unit 1860 can be at least one of the following: bar code (for example, 1-D, 2-D or 3-D), quick response (QR) code, image, shape, word, number, alpha-numeric string, color or any combination thereof or any kind of vision letter Cease storage unit.Information memory cell not in the visible spectrum can be used in other embodiments.Other embodiments can be with Using RFID label tag, RF information memory cell, IR Luminous label, or independent of the signal by being sent through visible spectrum Identification other markers.Certainly, information memory cell 1860 can also be positioned on the top end surface of sample vessel.Figure 18G is shown optionally, and information memory cell 1860 can be also comprised on the side surface of sample vessel.This can be additional to Or the one or more information memory cells 1860 positioned instead of top or bottom.

In a non-limiting example, information memory cell 1860 can be used for the sample in identical samples collection device Product and/or sample type.Optionally, one or more information memory cells may be present in each sample vessel.Some embodiments Can also on sample vessel holder use information storage unit.Sample storage unit can identical samples collection device, device The component of interior one or more single sample vessel or device.In some cases, can transport sample collection device, A part and/or sample vessel of sample collection device.It in one example, can be via delivery service or other are each herein Locate any other described service to transport the part of sample collection device or sample collection device.Sample device can be delivered Ware executes one or more detections in order to sample.

It is alternatively possible to track sample identity and/or provide the identity of the individual of sample.For lifting non-limiting example, It may include information associated with the one or more individual of sample is provided (for example, name, contact details, social insurance Number, date of birth, insurance information, bill information, medical history) and sample supplier other information.In some cases, may be used To track the type (for example, whole blood, blood plasma, urine etc.) of sample.Optionally, the reagent that sample will encounter can also be tracked Type (for example, anti-coagulants, marker etc.).It is contemplated that additional information about sample collection, such as the collection date and/or Locating environment when time, sample collection, will to the detection type that sample carries out, for one or more settings, the inspection of detection Survey scheme, insurance information, medical record information or any other type information.

In at least one or more embodiment described herein, information memory cell can the such letter of assistance tracking Breath.Information memory cell can be associated with such information.Such information can be stored in except sample collection device, sample Within collection device or any combination thereof.In some cases, the information can be stored on one or more external device (ED)s, The all for example servers of the external device (ED), computer, database or any other device with memory.In some cases Under, the information can be stored in cloud computing infrastructure.Storing up stored one or more resources can be distributed on cloud, is logical Internet is crossed from remote server and remote computer processor wireless connection etc..In some cases, it can provide a little To infrastructure.The information can be stored among information memory cell itself, or can be stored elsewhere with information single Member is associated or any combination thereof.

Optionally, information memory cell can provide unique identification, or can provide the possibility of high offer unique identification Property.In some cases, information memory cell can have visible component.It is detectable that information memory cell can be optics. In some cases, information memory cell, which can be, can be used visible light to recognize.In some instances, information storage is single Member can be bar code (for example, 1-D, 2-D or 3-D), quick response (QR) code, image, shape, word, number, alphabetical number Word string, color or any combination thereof or any kind of visual information storage unit.

In other embodiments, information memory cell can be can carry out optics inspection via the radiation of any other type It surveys.For example, information memory cell, which can be, to be come via the electromagnetism spectrum wavelength of infrared ray, ultraviolet light or any other type Detection.Information memory cell can use it is luminous, such as fluorescence, chemiluminescence, bioluminescence or any other type Light emitting.In some cases, information memory cell can be transmitting set and/or receiver.Information memory cell can To be radio frequency identification (RFID) label.Information memory cell can be any kind of wireless transmitter and/or receiver.Letter Breath storage unit can send one or more electric signals.In some cases, GPS or other positions coherent signal can be with letters Breath storage unit is used together.

Optionally, information memory cell can be and/or including audio component or acoustic assembly.Information storage is single Member can make a sound, the sound can be it is cognizable, to uniquely identify identified component.

Optionally, information memory cell can be and can detect via optical detection apparatus.For example, bar code scanning Instrument can read information memory cell.In another example, camera is (for example, the phase for static image or video image Machine) or other image capture devices can be capable of the image of captured information storage unit and analyze the image with determine mark Know.

Optionally, information memory cell can be located on the retainer of one or more sample vessel.It can be in retainer The one or more recess of middle offer.Information memory cell can be located in the recess.Recess can be located at retainer bottom surface or On side surface.In some embodiments, retainer may include one or more protrusions.It is convex that information memory cell can be located at this On rising.In some cases, information memory cell can be provided on the outer surface of retainer.Information memory cell can be with It is alternatively located on the inner surface of retainer.It can be from sample collection device external detection information memory cell.

In some embodiments, information memory cell can be located on the outer surface of sample vessel or sample vessel On inner surface.Information memory cell can be can be from sample vessel external detection.In some embodiments, can will believe Breath storage unit is provided in the bottom surface of sample vessel.

In a non-limiting example, retainer may include light transmissive portion.The light transmissive portion, which can be located at, protects On the bottom of holder or the side of retainer.For example, transparent or semitransparent window can be provided.In another example, light transmission Part can be the hole without window.Light transmissive portion allows partially visible in retainer.Information memory cell can To be provided on the outer surface of retainer in light transmissive portion, it is provided on the inner surface of retainer but light transmission can be passed through Part and as it can be seen that being provided on the outer surface or inner surface of sample vessel but can be visible by light transmissive portion.One In a little situations, information memory cell can be provided on the inner surface of sample vessel, but sample vessel can be it is light transmissive, So as to by sample vessel and/or light transmissive portion come observed information storage unit.

Optionally, information memory cell can be QR code, bar code or other optical information storage units, it is described other Optical information storage unit can be that optics is visible, such as, but not limited to can be from the external optical of sample collection device. It is visible that QR code can be the optical window of the bottom by the retainer in sample collection device, hole etc..QR code can mention For in a part on sample collection device retainer or by the visible sample vessel of retainer.Such as camera or sweep Retouching the image capture devices such as instrument can be provided in outside sample vessel or shipping container, and can read QR code.

In some embodiments, single or multiple QR codes or other information storage unit may be provided in sample collection dress It sets.In some cases, each sample vessel can have at least one information memory cell, QR such as associated there Code.It in one example, can be that each sample vessel are provided to a few window, and each window can in retainer User is allowed to observe QR code or other information storage unit.For example, two sample vessel can be accommodated in retainer, it is described Each of sample vessel have the associated information memory cell that can be recognized outside retainer.

In some embodiments, information memory cell can be provided with the sample vessel accommodated by retainer.It will Retainer mutually separates the rest part that may cause to sample vessel and sample collection device with the rest part of sample collection device Mutually separate.Sample vessel can be retained in retainer or can remove from retainer.Even if removing sample device from retainer Ware, information memory cell can be still retained in together with sample vessel.Alternatively, even if sample vessel are removed, information memory cell It can be still retained in together with retainer.In some cases, retainer and sample vessel can have information memory cell, with So that sample vessel and retainer even still can individually be tracked and/or be matched in separation.

In some cases, any number of sample vessel can be provided in sample collection device.Some embodiments All these sample vessel all once can be connected to sample collection device.It optionally, can in a sequential manner or other are non- Simultaneous system couples sample vessel.Sample vessel can be received from the received sample of subject.Each sample vessel Can optionally have unique information storage unit.Unique information storage unit can be related to sample, subject, device or dress Any information for the component set is associated.

In some cases, each information memory cell of each sample vessel can be uniquely, or comprising unique Information.In other embodiments, the information memory cell on sample vessel needs not to be unique.Optionally, some embodiment party Formula can have for device, for subject and/or be unique information for sample type.In some embodiments, Information on information memory cell can be used for several sample vessel are associated with same subject or same information.

In some embodiments, information memory cell is about periodically attached to or is otherwise associated with (object in collection Reason ground passes through the non-physical association such as database pointer or link) sample vessel or groups of sample vessel.If pressing group Association, then association can be based on all from other factors in same user or as set forth herein.Optionally, some implementations Mode can have information memory cell on sample vessel or groups of sample vessel.In a non-limiting example In, information memory cell provides marker information, and the marker information is then in the sample collection time or when closing on sample time It is associated with subject.In this example, the information on information memory cell remains unchanged but then links to subject.? In another embodiment, the information on information memory cell is changed into including the information about subject.Optionally, some Embodiment can both have concurrently, some of information be changed and some Information invariabilities (but can then with subject or such as Time of Day etc. is associated about the other information of Collection Events).

With reference to Figure 19 A to Figure 19 C, each embodiment of the front end of sample collection device will now be described.Figure 19 A is shown The top view of the front end of sample collection device, it is corresponding logical which there is opening 1103 and 1105 to be directed to it Road.In the present embodiment, opening 1103 and 1105 is positioned to come in close proximity to each other, is had between opening 1103 and 1105 There is partition wall 1910.In a non-limiting example, be arranged to can be by being used to form sample for the thickness of partition wall 1910 The manufacturing process of collection device and the minimum thickness being reliably formed.In one embodiment, wall thickness should be about 1-10 mm.In some embodiments, opening 1103 and 1105 may be at configuring up and down, diagonal configuration or two of them are opened The other configurations that mouth comes in close proximity to each other, to replace being arranged side-by-side.

9B referring now to figure 1, this embodiment illustrates be configured as opening 1910 and 1912 coaxial relative to each other. Such arranged coaxial of opening 1910 and 1912 allows the bigger overlapping between two openings.

9C referring now to figure 1, present embodiment are similar to the embodiment of Figure 19 B, and difference is these 1920 Hes of opening 1922 be circular, rather than square aperture.It should be appreciated that any various shape can be used, including but not limited to round, Ellipse, triangle, quadrangle (for example, square, rectangle, trapezoidal), pentagon, hexagon, octagon or any other Cross-sectional shape.Of course it is to be understood that different shape can be used for each opening, and collection device is for all The identical cross-sectional shape of the need not have that is open.Some embodiments can have a kind of cross-sectional shape for opening, but right There is different cross-sectional shapes in the channel of open downstream.

Single channel sample collection device

Referring now to Figure 20 A- Figure 20 B, although embodiments described herein is described generally as tool, there are two isolated channels Sample collection device, it is to be understood that, some embodiments can be used single into channel 2010.This is single into channel 2010 can be with coating or can be without coating.Suitable coating include but is not limited to anti-coagulants, plasma or Other materials.

Figure 20 A is shown in the present embodiment of sample collection device 2000, can be in single entering path 2010 Axially mounted on tissue penetration component 2112.This permission is formed in a manner of it will be aligned with single entering path 2010 to be located at Wound at destination organization.Tissue penetration component 2012 can be activated by one of multiple technologies, and the technology is such as but unlimited It will be filled in actuating, the actuating when device front end and destination organization contact when pressing trigger, or once with enough pressure It sets by the target tissue then by pressure actuated.After actuation, tissue penetration component 2012 is positively retained at single into logical In road 2010.Optionally, tissue penetration component 2012 can be retracted from single entering path 2010.

Sample fluid into sample collection device 2000 can be divided into two or more points from single entering path 2010 From access 2014 and 2016.This enables sample of the sample fluid from being collected in single contact point to be divided at least two A part.Two parts can be optionally held in the holding room 2018 and 2020 of two separation.It these rooms can be respective With one or more adaptor channels 2022 and 2024, by sample fluid be transferred to such as, but not limited to vessel 1146a and The vessel such as 1146b.It should be appreciated that holding room 2018 and 2020 and/or vessel 1146a and 1146b can include wherein Anti-coagulants is to prepare sample fluid for handling.

Referring now to Figure 20 B, this embodiment illustrates wherein with the single entering path of tissue penetration component 2012 2010, after actuation, the tissue penetration component 2012 is configured to wholly or partially be retained in single entering path In 2010.It should be appreciated that present embodiment can be used solid penetrating component or it is hollow, wherein being worn with inner cavity Saturating component.

With reference to Figure 21, the another embodiment of sample collection device 2030 will now be described.This embodiment illustrates have The single entering path 2032 that the length of tissue penetration component 2012 reduces, the tissue penetration component 2012 are configured for Extend outwardly from access 2032.After actuation, tissue penetration component 2012 can be located in access 2032 or optional Ground is withdrawn to not be located in access 2032.Sample fluid into sample collection device 2030 can be from single entering path 2032 are divided into the access 2034 and 2036 of two or more separation.This enables sample fluid from being collected in single connect Sample at contact is divided at least two parts.This embodiment illustrates accesses 2034 and 2036 to be maintained at capillary channel In configuration, and do not expand to become room, such as embodiment of Figure 20 A- Figure 20 B.It should be appreciated that any implementation of this paper Mode may each comprise for the one or more pad indicators for collecting access and/or the vessel on device, so that user It can know when to have reached enough fill levels.

It should be appreciated that due to the small sample volume being collected into such as, but not limited to vessel such as vessel 1146a and 1146b, " pulling " of reduced pressure (such as, but not limited to vacuum pressure) in vessel is by minimally may make Therefrom collect the blood vessel of sample fluid or other chamber collapses or the mode deleteriously remolded be transmitted in subject's body or It is not delivered in subject's body.For example, child patient and gerontal patient usually have small and/or fragile vein, work as use When traditional big volume vacuum tank, due to suck larger sample volume into those traditional vessel associated compared with Gao Zhen Empty power, the vein may collapse.In at least one embodiment of device, since it will not apply vacuum to vein (suction) power, therefore it will not have a problem that.In one embodiment, the amount of vacuum power is into vessel 1146a Draw the sample fluid for being no more than 120uL.Optionally, the amount of vacuum power is drawn into vessel 1146a is no more than 100uL.It can Selection of land, the amount of vacuum power is drawn into vessel 1146a is no more than 80uL.Optionally, the amount of vacuum power is inhaled into vessel 1146a It takes and is no more than 60uL.Optionally, the amount of vacuum power is drawn into vessel 1146a is no more than 40uL.Optionally, the amount of vacuum power It is drawn into vessel 1146a and is no more than 20uL.In one embodiment, such to draw without using syringe In the case of carry out, and be based primarily upon the pulling force from vessel and any power from the fluid for leaving subject.Optionally, Through device with draw have arrived at the sample inside device moulding access can aid in reduction from vessel 1146a and 1146b is transmitted to the power of the blood vessel of subject or other body cavitys.Some embodiments can be in small volume vessel listed above It is middle to use about 3/4ths vacuum or smaller, so that the haemolysis of sample minimizes and prevents the intracorporal blood vessel of subject from collapsing It falls into.Some embodiments can use about half vacuum or smaller in small volume vessel listed above, so that The haemolysis of sample minimizes and prevents the intracorporal blood vessel of subject from collapsing.Some embodiments can be listed above small Using about a quarter vacuum or smaller in volume vessel, so that the haemolysis of sample is minimized and is prevented in subject's body Blood vessel collapse.The vacuum of this paper is the perfect vacuum relative to atmospheric pressure.

It should be appreciated that in one embodiment, the cross-sectional area of the room in device is greater than for inhaling from subject Take the needle of body fluid and/or the cross-sectional diameter of flexible duct.This further aids in reduction and transmits to the power of subject.It comes from The vacuum pull of vessel is most directly to the fluid sample in device without directly to the sample in the needle closer to subject Product are drawn.Longer access is buffered by the large volume room in collection device, and which inhibits to subject's body vessel Pulling force.In addition, the initial spike pulling force in small volume vessel is substantially relative to large volume vessel also under vacuum Reduce.The duration of " drawing " also can be longer, so that a greater amount of samples is able to enter vessel.In smaller volume, institute A big chunk of the sample to be collected in a device, and there are it is less since drawn with subject and Sample is not yet in the sample in device before pulling.

With reference to Figure 22, the another embodiment of sample collection device will now be described.This embodiment illustrates have connection The collection device 2100 of device 2102, the connector is all for example but to be not limited to luer connector (Luer connector), is allowed It is connected to the various samples acquisition device such as tissue penetration component, needle.Press-fit can be used to connect in some luer connectors Other connectors are closed, and some embodiments of connector 2102 may include screw thread to promote to engage.Figure 22 is shown at this In current embodiment, butterfly needle 2104, which is coupled to, such as, but not limited to leads to the flexible pipe etc. of connector 2108 and fluidly connects Sample acquisition characteristics are connected to sample collection device 2100 by access 2106.Flexible duct 2106 allows needle part 2104 fixed Position is at separate sample collection device 2100 but still is operationally fluidly coupled to the sample collection device 2100.This allows in needle There is greater flexibility in terms of 2104 positioning, to acquire sample in the case where mobile example collection device 2100 need not be gone back Fluid.Optionally, some embodiments directly can couple dress for tissue penetration component in the case where not using flexible duct Set 2100.

At least some or all embodiments can have pad indicator, such as, but not limited to watch window or opening, Show when sample is present in collection device and thereby indicates that the one or more sample vessel of engagement are acceptable.It can Selection of land, however not excluded that the embodiment without pad indicator.Some embodiments can optionally include one or more Discharge orifice, such as, but not limited to port allow air to escape when being filled with sample to the channel in collection device.? In most cases, after reaching desired fill level, can by the sample vessel that be filled of one or more from Sample collection device disconnects.It is alternatively possible to one or more additional sample vessel are bonded to sample collection device, with Collect the humoral sample of additional quantity.Optionally, the interior condition of sample vessel be so that vessel have reduced pressure, thus It is configured for only sucking the sample fluid of predetermined amount.

Figure 23 shows the exploded view of an embodiment of sample collection device 2100.In the non-limiting example, Part 1130 can be configured for keeping vessel holder 1140 and the part with sampling apparatus retainer 2160.Device 2100 may include anti-leak device 2162, the open end of the engageable adaptor channel 2022 and 2024 of anti-leak device 2162 So that the sample loss by open end minimizes, until the vessel in retainer 1140 are engaged to any one thereto Pipette samples in a or multiple vessel.In the present embodiment, it is logical to cover at least two adapters for anti-leak device 2162 Road 2022 and 2024, and be configured to moveable.The present embodiment of anti-leak device 2162 is configured and dimensioned to Movement is made it possible to expose the opening in adaptor channel 2022 and 2024, while still allowing 2022 He of adaptor channel One or more vessel in 2024 splice holders 1140.

Referring now to Figure 24 and Figure 25, an embodiment of sampling apparatus retainer 2160 is illustrated in greater detail in figure. Sampling apparatus retainer 2160 is shown as assembling unit by Figure 24.Figure 25 is shown with first part 2164 and second part The exploded view of 2166 sampling apparatus retainer 2160.Adaptor channel 2022 and 2024 is also depicted as can be from second part 2166 remove.Although the present embodiment of sampling apparatus retainer 2160 is shown as two individual parts, but it should reason Sampling device retainer 2160 can be configured to single integrated unit by solution, some alternate embodiments.Optionally, Yi Xieshi The mode of applying can be configured to more than two part, and the part is fitted together to form retainer 2160.Optionally, one A little embodiments can along the longitudinal axis 2165 or other axis of retainer 2160 rather than created along the horizontal axis of retainer 2160 Individual part is built, this is as shown by the cut-off rule in Figure 25.

Referring now to Figure 26 to Figure 28, the embodiment of sampling device retainer 2160 and device 2100 is shown in figure Each cross-sectional view.Figure 26 shows the cross-sectional view of part 2164 and part 2166.Although inventionwithout being bound to any specific theory, But it can choose using individual part 2164 and 2166 to simplify manufacture, be especially used to form each in retainer 2160 A inner passage and room.For example, at least one wall 2167 of room can be formed in first part 2164, and the complementary wall of room 2168 can be formed in second part 2166.Figure 27 shows the vertical view end-view of part 2166, wherein can be with from the end-view See wall 2168.

With reference to Figure 28, the cross-sectional view of assembling device 2100 will now be described.The Figure 28 is shown to be entered by connector 2102 The sample of device will advance into common chamber 2170 lead to adaptor channel 2022 and 2024.From adaptor channel 2022 With 2024, movement of the retainer 1140 on the direction as indicated by arrow 2172 will be operationally by vessel 1146a It is fluidly coupled to adaptor channel 2022 and 2024 with 1146b, so that sample be moved into vessel from channel.In this embodiment party In formula, there is sufficient space 2174 to allow the movement of vessel 1146a and 1146b, so that adaptor channel 2022 and 2024 The cap of vessel 1146a and 1146b is penetrated, so that the inside stream of adaptor channel 2022 and 2024 and vessel 1146a and 1146b Body connection.Although illustrating only two vessel and adaptor channel group in attached drawing, it is to be understood that, there are more or less groups Vessel and the other configurations of adaptor channel also can be configured for being used together with device shown in such as Figure 28.

Modularization sample collection device

Referring now to Figure 29 A- Figure 29 C, it is used for although sample collection device usually is described as having by embodiments described herein The adaptor channel that sample collection channels are connected with vessel, it is to be understood that, however not excluded that without the implementation of such configuration Mode.

For lifting the non-limiting example in Figure 29 A, as previously proposed herein, some embodiments can be without dividing Vertical, separation adaptor channel.Here, collection channel 2422 can by as indicated by arrow 2449 in these elements One or both between relative motion mode and be connected directly to vessel 2446.

For lifting the non-limiting example in Figure 29 B, one or more adaptor channels 2454 can be discrete component, Its initially not with any one in direct fluid communication in collection channel 2422 or vessel 2446.Here, collection channel 2422 can lead to Cross the relative motion between collection channel, one or more one or more of adaptor channels 2454 or vessel 2446 Mode (in order or simultaneously) be connected to vessel 2446, with creation from collection channel pass through one or more of adaptations Device channel leads to the fluid passage in vessel.

For lifting the non-limiting example in Figure 29 C, one or more adaptor channels 2454 be can be initially and vessel 2446 elements being in contact.Adaptor channel 2454 can not be directly connected to the inside of vessel.Here, collection channel 2400 Vessel can be connected to (in order or simultaneously) by way of the relative motion between one or more of those elements, Pass through the fluid passage that one or more of adaptor channels are led in vessel to create from collection channel.Some embodiment party Formula can be on the one end for the collection channel that will be engaged by adaptor channel with diaphragm, sleeve, with the set of discharge orifice Cylinder or covering 2455.The engagement of each element can also move into adaptor channel 2454 in the inside of vessel 2446, because Initial adaptor channel 2454 may not be with the internal fluid communication.Some embodiments of this paper can have more than one Adaptor channel, and some embodiments may be used at the adaptor channel of the both ends with sharp end in channel.For this Embodiment described in text there may be variation and substitution, and any single embodiment should not be construed to include Entire invention.

It should be appreciated that any embodiment of this paper can be modified to include being explained in the description for Figure 29 A- Figure 29 C The feature stated.

Sample treatment

With reference to Figure 30, an embodiment of body fluid sample collection and transportation system will now be described.Figure 30 show by Humoral sample B on the skin surface S of examination person.In the non-limiting example of Figure 30, humoral sample B can be by a variety of devices One kind collect.For lifting non-limiting example, collection device 1530 can be but not limited to mention on September 6th, 2012 The U.S. Patent Application Serial Number 61/697 of friendship, collection device those of described in 797, the document pass through reference full text It is incorporated into this for all purposes.In the present embodiment, humoral sample B collected by one or more capillary channels and after And it is directed in sample vessel 1540.For lifting non-limiting example, at least one sample device in sample vessel 1540 Ware can have the inside being initially under partial vacuum, for humoral sample to be sucked into sample vessel 1540.Some implementations Sample can be sucked by mode simultaneously from the identical or different collection channel in sample collection device from sample collection device In sample vessel 1540.Optionally, some embodiments can suck the sample into simultaneously into sample vessel.

In the present embodiment, after humoral sample is in sample vessel 1540, in its retainer 1542 (or Person optionally, from its retainer 1542 remove) sample vessel 1540 be loaded in shipping container 1500.In the embodiment party In formula, there may be the one or more slots being dimensioned to for sample vessel holder 1542, or hold for transport The slot of sample vessel in device 1500.Lift non-limiting example for, the slot can by array configuration accommodate sample vessel and It is oriented vertical or some other scheduled orientations.It should be appreciated that some embodiments of sample vessel 1540 are configured to So that they accommodate different amounts of sample in each vessel.For lifting non-limiting example, this can be based on each sample The sample size collected in the amount of vacuum power in vessel, one or more sample collection channels of collection device and/or its His factor and controlled.Optionally, there may also be different pretreatments in sample vessel, such as, but not limited to different Anti-coagulants etc..

As seen in Figure 30, sample vessel 1540 are received just at first position (such as, but not limited to sample collection place) Collect sample.For lifting non-limiting example, humoral sample is then transported to the second position in shipping container 1500, this second Position such as, but not limited to reception site, such as, but not limited to analysis place.Transportation resources can be through express delivery, postal speed It passs or other transportation technologies.In many embodiments, can by have the another vessel that are accommodated therein shipping container come Realize transport.In one embodiment, sample collection place can be point-of care.Optionally, sample collection place is service Point.Optionally, sample collection place is far from sample analysis place.

Although Figure 30 this embodiment illustrates the collection from the surface of subject to humoral sample, other are alternative The collection technique for collecting sample from other regions of subject can be used in embodiment, such as by venipuncture, to fill out Fill one or more sample vessel 1540.Be not excluded for other such collection techniques be used for as the alternative of surface collection or with Surface collection is used in combination.Surface collection can be on the outer surface of subject.Optionally, some embodiments can be from tested In person's body can and surface be collected.The presence of humoral sample B on these surfaces with Lock-in or can pass through Wound create or make body fluid surface can and other technologies and occur.

Referring now to Figure 31, another embodiment there is described herein, wherein coming together on the surface of subject compared to collecting Sample, humoral sample can be collected out of subject body.Figure 31 the embodiment show with hypodermic needle 1552 Collection device 1550, which is configured for collecting humoral sample, such as, but not limited to venous blood.? In one embodiment, humoral sample can be with the room 1554 in filling device 1550, at this point it is possible to engage one or more samples Product vessel 1540 are to suck the sample into corresponding one or more vessel.Optionally, some embodiments can not have room 1554, but in addition to for guiding the one or more to one or more sample vessel 1540 to lead to from needle 1552 in sample There is very small spare space except road, one or more accesses or one or more pipes.For humoral sample such as blood Liquid, be from endovascular pressure so that blood sample can with filled chamber 1554 without from collection device it is very much (if If having) auxiliary.Such embodiment can optionally include one or more discharge orifices, such as, but not limited to port, Air is allowed to escape when being filled to the channel in collection device by sample.Optionally, some embodiments can have to receipts The direct needle attachment (rather than connect to the pipeline of needle) of acquisition means 1550 is similar to shown in Figure 44, and wherein needle is rigidly Or substantially rigidly it is connected to collection device.Some embodiments can have removable connection, it is releasable connection, Rule connects (Luer connection), is threadedly coupled, or other needle interconnection techniques that may be researched and developed in future.

At least some or all embodiments can have pad indicator, such as, but not limited to watch window or opening, Show when sample is present in collection device and thereby indicates that the one or more sample vessel 1540 of engagement are acceptable 's.Optionally, however not excluded that the embodiment without pad indicator.After reaching desired fill level, it can incite somebody to action The sample vessel 1540 that one or more is filled are disconnected from sample collection device.It is alternatively possible to by one or more additional Sample vessel 1540 be bonded to sample collection device 1550 (or 1530), to collect the humoral sample of additional quantity.

Service dot system

Referring now to Figure 32, it should be understood that automatic technology can be used to execute in procedures described herein.Automation Processing can be used in integrated, automation system.In some embodiments, this can be has multiple function wherein Energy component and the single instrument surrounded by public shell.The processing technique and method for settlement measurement can be preset. Optionally, can be based on can be by mode described in U.S. Patent Application Serial Number 13/355,458 and 13/244,947 And scheme or program that dynamic changes, above-mentioned document are incorporated by this for all purposes by reference.

In a non-limiting example as shown in Figure 32, integrated form instrument 2500 can be equipped with programmable processing Device 2502, the processor can be used for controlling multiple components of instrument.For example, in one embodiment, processor 2502 can To control the single or multiple pipetter systems that can be moved on the X-Y as indicated by arrow 2506 and 2508 and Z-direction 2504.Same processor or different processors can also control the other assemblies 2512,2514 or 2516 in instrument.One In a embodiment, the type of component 2512,2514 or 2516 includes centrifuge.

As seen in Figure 32, pipetter system 2504 can permit from cylinder casket 2510 by the control that processor 2502 is made Blood sample is acquired, and sample is moved to one of component 2512,2514 or 2516.Such movement can be related to cylinder Sample is distributed in detachable vessel in casket 2510, and the detachable vessel are then transported to component 2512,2514 Or one of 2516.Optionally, blood sample is directly distributed to being already installed on one of component 2512,2514 or 2516 On vessel in.In a non-limiting example, one of these components 2512,2514 or 2516, which can be, has imaging Configuration is to allow the illumination of sample and visual centrifuge in vessel.Other assemblies 2512,2514 or 2516 execute other Analysis, measurement or detection function.

All aforementioned items can be integrated in single shell 2520, and be configured for table top installation or small occupancy The installation of area ground.In one example, the surface-mounted system of small area occupied can occupy about 4m²Or smaller ground face Product.In one example, the surface-mounted system of small area occupied can occupy about 3m²Or smaller floor area.At one In example, the small surface-mounted system of area occupied can occupy about 2m²Or smaller floor area.In one example, little Zhan About 1m can be occupied with the surface-mounted system of area²Or smaller floor area.In some embodiments, instrument occupies face Product can 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、100 cm²、80cm²、70cm²、60cm²、50cm²、40cm²、30cm²、20cm²、 15cm²Or 10cm².One in service point environment is described in U.S. Patent Application Serial Number 13/355,458 and 13/244,947 A little suitable systems, above-mentioned document are all incorporated by this for all purposes by reference.Present embodiment can be matched It sets for being used together with any module or system described in these patent applications.

With reference to Figure 33 to Figure 37, the further embodiment of sample collection device will now be described.Such as institute in Figure 33 and Figure 34 See, at least one embodiment shows sample collection area 2600 with capillary channel region and then lower stream Region 2610 is hindered, which increases the cross-sectional area in channel to provide the stream of lower flow resistance and increase Speed.In at least one embodiment, which is still capillary channel, but one have it is lower The capillary channel of flow resistance.Optionally, other embodiments can increase size, and wherein sample flows wherein, but not be in hair The lower flowing of spy.The channel for increasing size can be also used for stored sample wherein.For lifting non-limiting example, this The storage of sample can be temporarily during collection, can be longer-term, such as from collection location to refrigeration, from collection Place is to the transport of reception site, and other Location-to-Locations transport or other purposes.One embodiment can be configured to With the cap on device both ends, so that sample is contained in wherein without being transferred to vessel 1146a and 1146b.

It, in this way can be with since the junction between region 2600 and 2610 can be positioned across the place of middle line 2620 Reduce by the object be bound up used in adhesives amount.It should be appreciated that embodiment can have such lead to Road 2612 and 2614: it channel cross section size having the same and/or is configured in the channel comprising phase Same or substantially the same volume.Optionally, channel 2612 and 2614 can be configured for accommodating different volumes.For It the channel may be same when it goes successively to region 2610.Optionally, some embodiments can be when in region 2610 There is different size when middle, and there is same size in region 2600, or vice versa.Other sizes are not excluded for match It sets.Although channel is shown as straight line here, it is to be understood that, for any embodiment disclosed herein, some implementations Mode can have the bending part or other non-straight parts in one or more channels.

Other component is similar to herein previously with respect to vessel 1146a and 1146b, adaptor channel, frit, retainer 130 Deng those described components.All wicking (filling time be both less than 6 second) of two channels in joint are improved (removing step) and blood readily enter channel in without inclined situation and pass through engaging zones.Component can be by PMMA, PET, PETG etc. are made.In this embodiment, this can provide logical relative to the capillary of a cross section size Fast 7.5 times of the filling in road, this is because the increase of the channel sized in region 2610 will allow to be easier into the region Flowing.

Change of the flow resistance based on channel sized in region 2610 and obtain quadruplicate reduction, such as institute in following formula See:

It should be appreciated that once there is desired sample size in one or more channels, then can configure some embodiments with Allow to manipulate sample to move into storage vessel.For lifting non-limiting example, such movement of sample, which can be, to be passed through The mode that pulling force, thrust or both have concurrently.In one embodiment, pulling force can be by vessel, the tool wherein with vacuum Have plunger or other moved to increase volume and in the vessel of the movable surface of wherein pipette samples or active vacuum Power provides.In one embodiment, thrust can be to mention behind an agent (bolus) or the grouping of other fluids The pressure of the air of confession or other gases.In embodiments, compressed gas can be applied, surround the close of device from having The pressure of cap sealing, sliding on collection device, is coupled to one end and applies syringe or other power of air pressure to promote Gas is forward.Provided power may differ from the power for collecting the sample in one or more channels.Optionally, some Embodiment can use different power in each channel.Optionally, some embodiments can be used opposite in region 2600 In the different power in area 2610.

Although illustrate and describing this introduction by reference to its certain particular implementation, art technology Personnel will be appreciated that, can make and change to program and the various of scheme without departing from the spirit and scope of the present invention System, changes, modifications, substitution, deletion or addition.For example, for any above embodiment, it should be understood that fluid sample Can be whole blood, diluted blood, tissue fluid, directly collected from the sample of patient, the sample on surface, by some pre- places Sample etc. after reason.It will be appreciated by those skilled in the art that alternate embodiment can have more than one vessel, the device Ware can be operably coupled to the opening in needle or channel in order to draw fluid into vessel.Optionally, some implementations Mode can have the vessel for being configured for operationally while being coupled to channel.Some embodiments can will pierce cutting apparatus Or other wounds are created device and are integrated with sample collection device, and target sample fluid is brought to tissue surface and is then received Collect sample fluid, these are all carried out using single device.For lifting non-limiting example, it can install spring-actuated , mechanically actuated and/or electromechanically tissue penetration component received with having from the sample near sample collection channels opening What the adjacent one end of acquisition means left penetrates tip so that the wound location createed also will along with collect opening one The same end of the device of sample.Optionally, integrated form device can have the opening of the collection on a surface of device, with And the tissue-penetrating element along another surface.In any embodiment disclosed herein, the first opening of collection channel There can be obtuse, be configured to be not easy to puncture the skin of people.

In addition, the blood flow that can increase to target area is pasted using heating on finger or other destination organizations, and from And enough blood or the speed of other body fluid can be drawn from subject by increasing.Heating is for rising to about destination organization 40C to 50C.Optionally, destination organization is risen to about 44 to 47C temperature range by heat.

In addition, it will be recognized by those skilled in the art any embodiment as described herein may be applicable to come From the collection of the sample fluid of the mankind, animal or other subjects.Some embodiments as described herein can also be suitble to use In the collection of non-biological fluid sample.The vessel that can not be removed from carrier can be used in some embodiments.Some embodiment party Formula can by the second power by fluid sample after be measured in sample collection part guidance to cylinder casket, this tin casket after And it is placed in analyte or other analytical equipments.Alternatively, it should be understood that although many embodiments show vessel position In carrier, but being not excluded for wherein vessel is embodiment that is exposed or being not installed in carrier.Some embodiments can To have the vessel separated with device, and the vessel are only just taken in the case where channel has reached minimum fill level It is in fluid communication.For example, vessel can be maintained at different positions, and sample only is in the blood of sufficient amount or sample fluid It is just contacted by technical staff when in product collection device.At this point it is possible to simultaneously or sequentially by vessel bring to sample collection One or more passages in the channel of device.

In addition, concentration, amount and other numeric datas can be presented herein with range format.It should be appreciated that such model It encloses format to use just for the sake of convenienct and succinct, and should be interpreted flexibly to not only include clearly being stated For the numerical value of range limit, but also the single number including being contained within the scope of this or subrange, like clearly stating Each numerical value and subrange.For example, the magnitude range of about 1nm to about 200nm should be construed as not only including clearly stating The boundary of about 1nm and about 200nm, but also extremely including single size such as 2nm, 3nm, 4nm and subrange such as 10nm 50nm, 20nm are to 100nm etc..

Shipping container

Referring now to Figure 38 A- Figure 38 B, the transport provided according to an embodiment described herein is shown in figure The decomposition perspective view of one non-limiting example of container 3200.It should be appreciated that shipping container 3200 can be configured to have this The one or more features of other any other described shipping containers everywhere of text.For lifting non-limiting example, transport Container 3200 can help to transport one or more sample vessel wherein.In some embodiments, shipping container 3200 mentions Thermal control interior zone has been supplied to make not expecting transporting sample to during another location (such as, but not limited to analysis facility) Sample thermally decompose minimize.It should be appreciated that during transportation, shipping container can be placed in other one or more vessel It is interior.

In one embodiment, sample vessel can be provided from the sample collection device for collecting humoral sample.Lift non-limit For property example processed, sample vessel can include sample in liquid form wherein.In most cases, liquid form It further include the embodiment for suspension.

For lifting non-limiting example, shipping container 3200 can have any size.In some cases, shipping container 3200 can have less than or equal to about 1m³、0.5m³、0.1 m³、0.05m³、0.01m³、1000cm³、500cm³、300cm³、 200cm³、 150cm³、100cm³、70cm³、50cm³、30cm³、20cm³、15cm³、10 cm³、7cm³、5cm³、3cm³、2cm³、 1.5cm³、1cm³、700mm³、 500mm³、300mm³、100mm³、50mm³、30mm³、10mm³、5mm³Or 1mm³Total measurement (volume).Fortune The area occupied and/or the maximum cross-section area of defeated container may be less than or equal to about 1m²、0.5m²、0.1m²、0.05m²、100cm²、 70cm²、50 cm²、30cm²、20cm²、15cm²、10cm²、7cm²、5cm²、3cm²、2cm²、 1.5cm²、1cm²、70mm²、50mm²、 30mm²、10mm²、5mm²Or 1 mm².In some cases, shipping container can have 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、 The size (for example, height, width, length, diagonal line or perimeter) of 0.5cm, 0.3cm or 1mm.In some cases, it transports The full-size of container can no more than about 1m, 75 cm, 50cm, 30cm, 25cm, 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.7cm, 0.5 cm, 0.3cm or 1mm.

Optionally, shipping container can be light-duty.In some embodiments, shipping container has or not wherein Weight in the case where with sample vessel can 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、3 g、2g、1g、500mg、300mg、 200mg, 100mg, 70mg, 50mg, 30mg, 10mg, 5mg or 1mg.

As seen in Figure 38 A and Figure 38 B, an embodiment of shipping container can have top cover 3210, be used for The shell 3220 of heat regulating device, one or more insertion pallet 3230a, 3230b and bottom plate for shipping container 3240。

In one embodiment, top cover 3210 has substantially flat shape, but is not excluded for other shapes Shape.Top cover 3210 can cover heat regulating device, such as, but not limited to include heater or cooling in a transport container Device.Top cover can have or can not have occupancy face identical with the shell 3220 for heat regulating device Product.Cooler, heater or other heat regulating devices 3220 may be provided in shipping container 3200.Optionally, described device 3220 can be active cell or passive unit.Sample vessel in shipping container 3200 can be held in the phase by heat regulating device The temperature of prestige is lower than predetermined threshold.Optionally, heat regulating device can be any temperature control as known in the art Unit processed.Optionally, heat regulating device can heat and/or cool.Optionally, heat regulating device can be thermoelectric cold But device.Optionally, heat regulating device can be encapsulated in top cover and between the shell of cooler.

Optionally, top cover and shell can be formed or can not be formed gas-tight seal.Top cover and/ Or shell can be formed by the material with desired thermal conductivity.For example, shell 3220 can have selectable thermal conductivity.? In one embodiment, shell may include the phase-change material (PCM) of the insertion in the tank material, therefore temperature base everywhere It is consistent in sheet.PCM possesses extraordinary temperature curve.It is expected that not causing the supercooling of sample, such as associated with ice, this may Create the negative drop down to -5 DEG C.PCM can be configured for controlling temperature range above freezing.Lift non-limiting example For, thermal conductivity can be in the range between about 100-250W/m/K (watts/meter/Kelvin).Optionally, each sample Product vessel will be in contact with PCM.Some embodiments can have a PCM for each layer.PCM material can flow modeling and arrive In shipping container material.It is alternatively possible to which there are the rooms of PCM material.It is alternatively possible to PCM come between in filled trays Gap.PCM can provide passive thermal control technology.

Optionally, PCM can be incorporated into injecting forming material.In such an embodiment, entire vessel can be cold But medium.This can also prevent PCM from leaking from the room in shipping container.When PCM is integrated directly into shipping container material, fortune Defeated container size can also reduce.Since the storage volume of unit mass increases, energy density is bigger.By plastics with PCM material, which mixes, can be configured to not only have intensity but also can cool down.For lifting non-limiting example, the 30% of material can be with It is PCM and rest part is to provide the plastics of rigidity.For lifting non-limiting example, material 20% to 40% between can be with It is PCM, and rest part is another material, such as, but not limited to provides the plastics of mechanical stiffness.Some embodiments can make With by PCM or other materials filling, blow molding outside.Inside can be formed with different technologies, this is because interior Portion attractive in appearance may not be not crucial.Optionally, can also use cast molding or other lower temperatures at Type technique substitutes the injection moulding of the shipping container material for being integrated with PCM or in conjunction.The PCM of insertion can be with It is in pallet.Some embodiments can be the much bigger pallet of thermal conductivity, to realize uniform, consistent cooling curve.It can Selection of land, PCM material include in the room in the chassis of shipping container, wherein the wall of the room can than transport case chassis its His wall thickness in region is thinner.

In one embodiment, each of pallet 3230a and 3230b can be also configured to by shipping container 3200 So that any information memory cell on sample vessel can easily be read, without removing sample from pallet 3230a and 3230b Product vessel.In one example, retainer has opening in bottom, which allows the information memory cell on bottom in sample It is visible while product vessel are still in pallet 3230a and 3230b.

Figure 39 shows multiple views of shipping container 3200.Some views are shown in pallet 3230a or 3230b Sample vessel holder can have open bottom, in order to from following or do not require sample vessel from shipping container 3200 Other orientations removed read any information memory cell, such as, but not limited to bar code or other information storage unit. Optionally, certain parts (such as, but not limited to layer, pallet etc.) of shipping container 3200 are removed only to obtain desired information. It is alternatively possible to access bar code or other information storage unit by one or more openings in pallet.This allows pair The bar code scanning of very small shipping container.It is alternatively possible to individually scan rows of sample vessel, or can be with one It is secondary all to scan entire pallet.Optionally, user can see all samples vessel holder.Optionally, computer vision system System can also scan with check such as centrifuge separation and etc. whether complete.This can be the either end in transportational process.It is described Computer vision system can visualize sample vessel, and determine whether the sample of there is in confirmation and completes expectation step Rapid form.If it detects that the problem can be informed user or system and/or re-execute something lost by mistake, system Leakage and/or wrong the step of executing.Optionally, retainer can have closed bottom, and information can be and transport On the side of defeated container 3200 or other surfaces.

In some embodiments, the shape of retainer can also be designed to follow the sample vessel 3134 being located therein Profile, to increase contact surface area and improve thermal control to sample vessel.Optionally, the thermal control of sample vessel It can be and being transmitted with the heat of pallet and/or PCM, but do not contacted directly with PCM.Optionally, some sample vessel 3134 can also directly contact with vessel and/or PCM.The opening of sample vessel and/or retainer, which can be in line, goes, at bee Nest pattern or at another pattern.

Referring now to Figure 40 A and Figure 40 B, the shipping container 3200 assembled completely is shown in figure.Figure 40 B shows multiple Sample vessel 3134, those sample vessel such as associated with sample collection device.Sample vessel 3134 can be all from The information storage list for being associated with pallet 3230a can be used in sample associated with a subject in this case Member provides the information about this group of sample.Optionally, single sample vessel can respectively still have with pallet 3230a's The identical information memory cell of information memory cell or they can be individually unique.Some embodiments can will come from The sample vessel of multiple subjects are inserted into same pallet 3230a.Optionally, some embodiments can be filled out only partially Fill each pallet.Some embodiments can be with each opening in filled trays, but not each sample vessel will be at it In have sample (that is, some sample vessel may be sky sample vessel, being inserted into provide uniform heat distribution).These Stackable pallet 3230a can have closing device, the closing device using such as, but not limited to magnet, mechanical latches or Pallet is coupled by the elements such as other coupling mechanisms.In some embodiments, magnet can be used to engage and accommodate The pallet of sample vessel, to support in the automation process for loading and unloading convenient for opening.Optionally, user cannot be from Shipping container removes pallet.Optionally, user cannot move without using tool to discharge pallet from shipping container Except pallet.Some embodiments have press button mechanism (magnetic or other technologies).In this way, patient service center can To be put into sample but cannot be drawn off.Optionally, some embodiments can have selected moulding opening, so that a People can not place sample vessel and/or its retainer in a wrong manner, to prevent user's mistake.

In one embodiment, loading and/or unloading can be adjusted in room or room in temperature occurs, and sample is protected It holds in desired temperature range.In one embodiment, the temperature range being desired to have between about 1 DEG C to 10 DEG C.It can Selection of land, the temperature range being desired to have between about 2 DEG C to 8 DEG C.Optionally, the temperature being desired to have between about 4 DEG C to 5 DEG C Spend range.Optionally, the material of pallet 230a and 230b can be used for providing temperature controlled atmosphere for sample vessel.Some realities Apply mode and control using convection current the heat distribution in shipping container 200.

Figure 40 B is also shown in this specific embodiment, and there may be for O type ring or other sealing elements Groove 3232, the sealing element can provide the close connection between the layer of shipping container.System may also include close mechanism 3234, such as, but not limited to magnetic closing device, Stackable insertion pallet to be maintained on desired locations.It should manage Solution, some embodiments can have the through-hole 3236 for being routed for one or more sensors, insert to detect Stackable Enter the condition that pallet is undergone during transportation.

Figure 40 C show ought the various components such as Stackable pallet and cover board be bound up with formed transport hold When device 3200, each perspective view of the embodiment of Figure 40 A and Figure 40 B.As seen in Figure 40 C, shipping container may include multilayer Sample vessel or pallet with sample vessel.Optionally, some embodiments can only have single layer samples vessel.Some realities The mode of applying can use active cooling or thermal control in one or more layers of shipping container 3200.Lift non-limiting example and Speech, an embodiment can have thermoelectric (al) cooler in top layer.Optionally, Active thermal control can be used in some embodiments The combination of system and passive thermal control.For lifting non-limiting example, an embodiment can have caloic, such as, but not limited to It has been in the phase-change material (PCM) of preferred temperature.It may include active thermal control unit so that PCM is maintained at desired temperature It spends in range.Optionally, some embodiments can keep the temperature at expectation using only caloics such as such as, but not limited to PCM In range.

Shipping container with removable pallet

With reference to Figure 41, the another embodiment of shipping container will now be described.Figure 41 is shown with inside thermal control 3302 Shipping container 3300,3302 have accommodated the pallet that multiple sample vessel 3306 can be accommodated by array configuration inside the thermal control 3304, wherein each of vessel 3306 accommodate the major part of its sample in free-flowing, non-wicking form, and Wherein there is about 1ml or less sample fluid in each vessel.Optionally, there is about 2ml or less sample in each vessel Product fluid.Optionally, there is about 3ml or less sample fluid in each vessel.In a non-limiting example, by device Ware be arranged so that in each shipping container there are at least two with the sample fluid from same subject vessel, Wherein at least the first sample includes the first anti-coagulants and the second sample includes the second anti-coagulants in matrix.

Although Figure 41 shows the sample vessel kept with array configuration, it is not excluded for other predetermined configurations.Some implementations Mode sample vessel can be placed in pallet it is hinged, swing or other holding mechanisms in, the mechanism allow at one or Movement in two freedom degrees.Sample vessel can be placed into such device by some embodiments: the device is loading Period has the first configuration and the second configuration is presented during transportation then to keep sample vessel.Some embodiments can Sample vessel are placed into such material: the material has the first material properties during loading and is then transporting The second configuration (such as, but not limited to hardening) is presented to keep sample vessel in period.

In some embodiments, sample vessel are in retainer 3310, and pallet 3304 defines that size is set It is fixed at cooperation retainer 3310 rather than the opening and/or cavity of sample vessel.For lifting non-limiting example, retainer 3310 It can be used for being physically persisted in together when associated vessel 3306 are in pallet 3304.Some embodiments have The retainer 3310 of pallet 3304 is contacted, directly to protect vessel not contact directly with pallet 3304.It is non-limiting at one In example, pallet can accommodate at least 100 vessel, or optionally, and at least 50 respectively there are two the retainers of vessel for tool.

Referring still to Figure 41, the embodiment of shipping container 3300 can have certain holding mechanism 3320, such as but unlimited In clip, magnetic regions etc., to keep pallet 3306.The side that holding mechanism 3320 can be configured to can discharge when desired Formula keeps pallet 3304.Optionally, holding mechanism 3320 can be configured to keep pallet 3304 in a non-releasable manner.? In embodiment shown in Figure 41, holding mechanism 3320 is shown as magnetism and/or metal component in pallet 3304, should Component is attracted to metal and/or magnetic component in shipping container 3300.When shipping container 3300 reaches treatment facility, Pallet 3304 can be configured to remove from shipping container 3300.This can be by using including but is not limited to use kicker magnet One or more technologies such as magnetism and/or metal component in splice 3304 and occur.Folder can be used in some embodiments Pincers, hook or other mechanical mechanisms to remove pallet 3304 from shipping container 3300.A variety of skills can be used in some embodiments The combination of art removes pallet 3304.It is also understood that some embodiments may be selected to remove vessel 3306 and/or retainer 3310, and pallet 3304 is retained in shipping container 3300.Some technologies can carry out two or more skills in aforementioned techniques Art.

It is also understood that shipping container 3300 itself can be cooling device, including heat management material, it is such as but unlimited Yu Bing, PCM etc..Heat management material can be integrated directly into the material for being used to form shipping container 3300 by other embodiments. As seen in Figure 41, some embodiments of shipping container 3300 can have substantially vacant space 3324, accommodate wherein Or incorporate one or more heat management materials.

Referring still to Figure 41, shipping container 3300 may also include opening 3330, for the attached of hinge or other attachment devices It connects, connection of the attachment device for covering or other layers to shipping container 3300.For ease of explanation, in Figure 41 not Covering and/or the connection to covering or other layers are shown.Although single layer can be used only in some embodiments, but it should Understand, however not excluded that the embodiment of multilayer.

With reference to Figure 42, the decomposition perspective view of the another embodiment of shipping container 3400 will now be described.The embodiment party of Figure 42 Formula is designed to for pallet 3402 being maintained in 3404 inside shipping container.Exploded perspective is shown in pallet 3402 Multiple vessel 3406 in retainer 3410.Pallet 3402 may be configured such that some or all of portions of retaining mechanism 3420 The retaining mechanism 3320 that classification is similar in pallet 3402.It is also understood that pallet 3402 can have one or more notch, convex Rise or feature, with allow pallet 3402 with it is a limited number of it is predetermined orientation be inserted into the inside.Some embodiments can quilt It is configured to only support pallet in vessel orientation.Some embodiments can be configured for only supporting pallet in device Two possible orientations in ware.

Figure 42 is shown in one embodiment, and shipping container 3400 can be by two individual parts 3430 and 3432 It is formed.Optionally, some embodiments can be formed by three or more parts.Optionally, some embodiments can be list One part.Part 3430 and 3432 can have the opening filled by plug 3434 and 3436.The inside of shipping container 3400 3438 can keep heat management material, such as, but not limited to ice, phase-change material etc..Other embodiments can be straight by heat management material It connects in the material for being integrated into and being used to form shipping container 3400.

In one case, the inside of part 3432 can be filled with heat management materials such as such as, but not limited to PCM 3433.Optionally, Active thermal control prepared material, such as, but not limited to thermoelectric (al) cooler can be used in an embodiment, to cooling The inside.

With reference to Figure 43, the another embodiment of shipping container 3500 will now be described.Figure 43 shows shipping container 3500 can Including the cover board 3502 for covering the feature being located therein and/or sample vessel.In some embodiments, cover board 3502 It may include heat-insulating material.Optionally, cover board 3502 may include thermal control units, to assist the inside of shipping container 3500 It is maintained within the temperature range of expectation.Optionally, cover board 3502 can be configured to Heat Conduction Material by some embodiments, can be led to The heat transmitting from external thermal control source is crossed to help the inside by shipping container 3500 to be maintained within the temperature range of expectation.It lifts For non-limiting example, thermal control source can be cooling source, heating source, thermoelectric heat exchanger or other heat control devices. It is also understood that can also include similar thermal control source in the spare space 3514 under layer 3516, such as, but not limited to PCM or active cooling device.

It should be appreciated that for keep retainer 3310,3410 or other for vessel moulding retainer feature 3512 It can be located in the part separated with shipping container or it can be integrally molded in shipping container.Optionally, feature 3512 It can be a part of pallet (pallet 3302 and 3402 shown in such as Figure 41 and Figure 42).Such pallet can be solid Fixed, or can be removed from shipping container 3500.Holding mechanism 3520 can also be incorporated into pallet, to allow it It is held in place during transportation.

Sample collection and transport

In embodiments, there is provided herein the system and method for the collection of the humoral sample for small size or transport.

In embodiments, the sample vessel of the humoral sample comprising small size can be transported.Sample and sample vessel can With other described any individual features everywhere herein.In embodiments, sample vessel may include being less than or equal to 5ml、3ml、4ml、2ml、 1.5ml、1ml、750l、500l、400l、300l、200l、150l、 100l、75l、50l、40l、 The humoral sample of 30l, 20l, 10l or 5l.In embodiments, sample vessel can have less than or equal to 5ml, 3 ml, 4ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l or The internal capacity of 5l.In embodiments, sample vessel can have less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, The internal capacity of 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l or 5l, and And may include be filled with the vessel at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, the humoral sample of 98%, 99% or 100% internal capacity.In embodiments, sample vessel can be sealed, example Such as, it is sealed with cap, cover board or film.Any vessel inside dimension or sample size described herein can be respectively suitable for The inside dimension of the sample vessel of sealing, or the size in sample therein.In embodiments, the sample device of sealing Ware can have less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, The internal capacity of 100l, 75l, 50l, 40l, 30l, 20l, 10l or 5l, and it may include and is filled with the vessel at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99% or 100% inside holds Long-pending humoral sample so that sealing vessel internal capacity in exist less than or equal to 2ml, 1.5ml, 1ml, 750l, The sky of 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l, 5l, 4l, 3l, 2l or 1l Gas.Therefore, for example, the sample vessel of sealing can have the internal capacity less than or equal to 300l, and it can wrap Humoral sample containing at least 90% internal capacity for being filled with the vessel, so that existing in the internal capacity of sealing vessel Air less than or equal to 30ul.In another example, the sample vessel of sealing can have the inside less than or equal to 500l Volume, and it may include and is filled with the humoral sample of at least 80% internal capacity of the vessel, so that in sealing vessel Internal capacity in exist less than or equal to 100 ul air.In another example, the sample vessel of sealing, which can have, is less than Or the internal capacity equal to 150 l, and other may include and are filled with the body fluid of at least 98% internal capacity of the vessel Sample, so that there is the air less than or equal to 3l in the internal capacity of sealing vessel.

In embodiments, wrapping sample vessel with sample also may include anti-coagulants.Anti-coagulants can dissolve in the sample or Otherwise be present in vessel (for example, it is dry in one or more interior surfaces of vessel, or in solid form Positioned at the bottom of vessel).Wrapping sample vessel with sample can have " total anticoagulant agent content ", wherein total anticoagulant agent content The total amount for the anti-coagulants being present in the internal capacity of vessel, and including dissolve in the sample anti-coagulants (if there is Words) and vessel in undissolved anti-coagulants (if any) in the sample.In embodiments, sample with sample is wrapped Vessel may include the sample no more than 1ml and have the total anticoagulant agent content for being no more than 3mg EDTA, may include being no more than The sample of 750l and have no more than 2.3mg EDTA total anticoagulant agent content, may include no more than 500l sample and It may include being no more than the sample of 400l and having to be no more than with the total anticoagulant agent content for being no more than 1.5 mg EDTA Total anticoagulant agent content of 1.2mg EDTA may include no more than the sample of 300l and having total no more than 0.9mg EDTA Anticoagulant agent content may include the total anticoagulant agent content for being no more than the sample of 200l and having no more than 0.6mg EDTA, can Comprising the sample no more than 150l and there is the total anticoagulant agent content for being no more than 0.45mg EDTA, may include being no more than 100l Sample and have no more than 0.3mg EDTA total anticoagulant agent content, may include no more than 75l sample and have Total anticoagulant agent content no more than 0.23mg EDTA may include the sample no more than 50l and have no more than 0.15mg Total anticoagulant agent content of EDTA may include the sample no more than 40l and have the total anti-coagulants for being no more than 0.12mg EDTA Content may include the sample no more than 30l and have the total anticoagulant agent content for being no more than 0.09mg EDTA, may include not More than the sample of 20l and have no more than 0.06 mg EDTA total anticoagulant agent content, may include no more than 10l sample simultaneously And there is the total anticoagulant agent content for being no more than 0.03mg EDTA, or may include being no more than the sample of 5l and having not surpass Cross total anticoagulant agent content of 0.015mgEDTA.In embodiments, wrapping sample vessel with sample may include being no more than 1ml Sample and have no more than 2mg EDTA total anticoagulant agent content, may include no more than 750l sample and have do not surpass The total anticoagulant agent content for crossing 1.5mg EDTA may include no more than the sample of 500l and having total no more than 1mg EDTA Anticoagulant agent content may include the total anticoagulant agent content for being no more than the sample of 400l and having no more than 0.8mg EDTA, can Comprising the sample no more than 300l and there is the total anticoagulant agent content for being no more than 0.6mg EDTA, may include being no more than 200l Sample and have no more than 0.4mg EDTA total anticoagulant agent content, may include no more than 150l sample and have Total anticoagulant agent content no more than 0.3mg EDTA may include the sample no more than 100l and have no more than 0.2mg Total anticoagulant agent content of EDTA may include the sample no more than 75l and have the total anti-coagulants for being no more than 0.15mg EDTA Content may include the sample no more than 50l and have the total anticoagulant agent content for being no more than 0.1mg EDTA, may include not super Cross the sample of 40l and have no more than 0.08 mg EDTA total anticoagulant agent content, may include no more than 30l sample and It may include being no more than the sample of 20l and having to be no more than with the total anticoagulant agent content for being no more than 0.06mg EDTA Total anticoagulant agent content of 0.04mg EDTA may include no more than the sample of 10l and having total no more than 0.02mg EDTA Anticoagulant agent content, or may include the total anticoagulant agent content for being no more than the sample of 5l and having no more than 0.01mgEDTA. In embodiments, wrapping sample vessel with sample may include being no more than the sample of 1ml and having to be no more than 30 United States Pharmacopeias (USP) total anticoagulant agent content of units heparin may include the sample no more than 750l and have no more than 23USP unit liver Total anticoagulant agent content of element may include the sample no more than 500l and have the total anti-coagulants for being no more than 15USP units heparin Content may include the sample no more than 400l and have the total anticoagulant agent content for being no more than 12USP units heparin, may include No more than the sample of 300l and there is the total anticoagulant agent content for being no more than 9USP units heparin, may include being no more than 200l Sample and have no more than 6USP units heparin total anticoagulant agent content, may include no more than 150l sample and have No more than total anticoagulant agent content of 4.5USP units heparin, it may include the sample no more than 100l and have no more than 3USP Total anticoagulant agent content of units heparin may include no more than the sample of 75l and having total no more than 2.3USP units heparin Anticoagulant agent content may include the total anticoagulant agent content for being no more than the sample of 50l and having no more than 1.5USP units heparin, It may include the sample no more than 40l and there is the total anticoagulant agent content for being no more than 1.2 USP units heparins, may include being no more than The sample of 30l and have no more than 0.9USP units heparin total anticoagulant agent content, may include no more than 20 l sample simultaneously And there is the total anticoagulant agent content for being no more than 0.6USP units heparin, it may include being no more than the sample of 10l and having to be no more than Total anticoagulant agent content of 0.3USP units heparin, or may include being no more than the sample of 5l and having to be no more than 0.15 USP Total anticoagulant agent content of units heparin.In embodiments, wrapping sample vessel with sample may include the sample no more than 1ml And there is total anticoagulant agent content no more than 15USP units heparin, may include being no more than the sample of 750l and having not surpass The total anticoagulant agent content for crossing 11USP units heparin may include no more than the sample of 500l and having mono- no more than 7.5USP Total anticoagulant agent content of position heparin may include no more than the sample of 400l and having total anti-no more than 6USP units heparin Solidifying agent content may include the total anticoagulant agent content for being no more than the sample of 300l and having no more than 4.5USP units heparin, It may include the sample no more than 200l and there is the total anticoagulant agent content for being no more than 3USP units heparin, may include being no more than The sample of 150l and there is total anticoagulant agent content no more than 2.3USP units heparin, may include the sample no more than 100l And there is total anticoagulant agent content no more than 1.5USP units heparin, may include being no more than the sample of 75l and having not surpass The total anticoagulant agent content for crossing 1.2USP units heparin may include no more than the sample of 50l and having mono- no more than 0.75USP Total anticoagulant agent content of position heparin may include no more than the sample of 40l and having total anti-no more than 0.6USP units heparin Solidifying agent content may include the total anticoagulant agent content for being no more than the sample of 30l and having no more than 0.45USP units heparin, It may include the sample no more than 20l and there is the total anticoagulant agent content for being no more than 0.3USP units heparin, may include being no more than The sample of 10l and there is total anticoagulant agent content no more than 0.15USP units heparin, or may include the sample no more than 5l Product and have no more than 0.08USP units heparin total anticoagulant agent content.

In embodiments, it can get or transport two or more samples comprising the sample from single subject Vessel.When obtain or transport include the sample from single subject two or more sample vessel when, it is described two or More vessel can be stored or be transported in the vessel comprising or not comprising the sample from other subjects.In embodiment In, it can get or transport includes at least 2,3,4,5,6,7,8,9 or 10 sample vessel of the sample from single subject. In embodiments, can get or transport comprising the sample from single subject be no more than 2,3,4,5,6,7,8,9 or 10 sample vessel.In embodiments, can get or transport comprising the sample from single subject at least 2,3,4,5, 6,7,8 or 9 sample vessel and be no more than 3,4,5,6,7,8,9 or 10 sample vessel.It is being related to comprising from same In the embodiment of two or more sample vessel of the sample of subject, the sample in each sample vessel can be identical Or different time is obtained from subject.It is being related to two or more sample vessel comprising the sample from same subject Some embodiments in, the sample in each sample vessel may be from same position or source position with subject. For example, can get two sample vessel comprising the whole blood from same subject, wherein the two sample vessel all include to come Whole blood from same fingerstick position.It is being related to two or more sample devices comprising the sample from same subject Different location/source position of the sample with subject in the other embodiments of ware, in each sample vessel.Example Such as, two sample vessel comprising the whole blood from same subject be can get, one of sample vessel include to come from first The whole blood at fingerstick position (for example, on the first finger/toe), and the second sample vessel include to pierce position from second-hand's pointer The whole blood of (for example, on the second finger/toe).It is being related to two or more sample devices comprising the sample from single subject In the embodiment of ware, the two or more sample vessel may include different types of anti-coagulants or the addition of other blood Agent.For example, the first sample vessel may include having the whole blood of EDTA and the second sample vessel may include the whole blood with heparin, Wherein sample comes from same subject.In another example, the first sample vessel and the second sample vessel may include with EDTA Whole blood and third sample vessel may include the whole blood with heparin, wherein sample come from same subject.In another example In, the first sample vessel may include the whole blood with EDTA, and the second sample vessel may include the whole blood with heparin, and third Sample vessel may include the whole blood with sodium citrate, and wherein sample comes from same subject.Be related to comprising from it is single by In the embodiment of two or more sample vessel of the sample of examination person, the two or more sample vessel may include Different types of sample from subject.For example, the first sample vessel may include whole blood and the second sample vessel may include coming From the blood plasma of same subject.In another example, the first sample vessel may include whole blood and the second sample vessel may include coming From the urine of same subject.In another example, the first sample vessel and the second sample vessel may include whole blood, and third sample Product vessel may include the saliva from same subject.

In system and method provided herein, the humoral sample of total volume can be obtained from subject.The body fluid of total volume Sample can be transferred in simple sample vessel, or be transferred in two or more sample vessel.For example, can be obtained from subject It obtains total volume and is 500 microlitres of humoral sample, and can be transferred into simple sample vessel, wherein the simple sample Vessel have 600 microlitres of maximum internal volume.In another example, the body that total volume is 500 microlitres can be obtained from subject Liquid sample, and can be transferred into two sample vessel, wherein each sample vessel have 300 microlitres of maximum internal Volume.In another example, total volume can be obtained from subject and is 500 microlitres of humoral sample, and can be transferred into In two sample vessel, one of sample vessel have 400 microlitres of maximum internal volume and a sample vessel have 100 microlitres of maximum internal volume.In system and method provided herein, can be obtained from subject less than or equal to 5 ml, 4ml、3ml、2ml、1.5ml、1ml、750l、500l、400l、 300l、200l、150l、100l、75l、50l、40l、30l、 The humoral sample of the total volume of 20l, 10l, 5l or 1l.The humoral sample of total volume from subject can 1,2,3,4,5, 6, it is distributed between 7,8,9,10 or more sample vessel, such as other are described everywhere herein.When from the total of subject When the humoral sample of volume distributes between two or more sample vessel, in some or all of different sample vessel The part of humoral sample of total volume may include different anti-coagulants or other additives.For example, can be obtained from subject always Volume is 500 microlitres of humoral sample, and can be transferred into two sample vessel, and one of sample vessel include 250 microlitres of humoral samples of EDTA are mixed with, and a sample vessel include 250 microlitres of humoral samples for being mixed with heparin.In general, As used herein, the humoral sample of total volume means the humoral sample of single type --- for example, whole blood or urine or saliva Deng.

In embodiments, the sample vessel comprising whole blood can be centrifuged before its storage or transport, so that Whole blood is separated into the cell of blood plasma and precipitating before the transport of sample vessel.In other embodiments, comprising the sample of whole blood Product vessel are not centrifuged before its storage or transport.

In some embodiments of system and method provided herein, humoral sample is after its collection and at it It can be dried before transport.In embodiments, dry sample can be in liquid form in later reconstruction, such as to sample Analysis or processing when rebuild.

In the embodiment of system and method provided herein, sample vessel can be transported from first position to second Position.First position can be the position that sample is collected from subject, and the second position can be to handle or analyze this Sample and the position for executing one or more steps.Sample and sample vessel can have this paper, and other are described any everywhere Individual features.For example, sample can be liquid, non-matrix, non-wicking form.Sample vessel can be as retouched herein It is transported in the shipping container stated or in other structures.For example, in some alternative embodiments, it can be in packet, pouch, letter Sample vessel are transported in envelope, box, capsule or other structures.In embodiments, the first position and the second Setting can be in same room, building, garden or groups of building.In embodiments, first position and the second position can be separated by At least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 km, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms or 500 kms.In embodiments, first position and the second position can be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 km, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms, 500 Km or 1000 kms.In embodiments, first position and the second position can be separated by least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 km, 5 kms, 10 kms, 15 kms, 20 kms, 30 kms, 50 kms, 100 kms or 500 kms And it is no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 km, 5 kms, 10 kms, 15 kms, 20 kms, 30,000 Rice, 50 kms, 100 kms, 500 kms or 1000 kms.It is the implementation that the position of sample is obtained from subject in first position In mode, can from subject collect 48 hours of sample, 36 hours, 24 hours, 12 hours, 8 hours, 6 hours, it is 4 small When, 3 hours, 2 hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, in 1 minute or 30 seconds by sample Vessel are transported from first position to the second position.

" sample reception place " used herein is to can receive the place of the sample through transporting, and wherein can be right Sample executes one or more steps.For example, reaching the sample in sample reception place can obtain everywhere in the sample reception place Reason, analysis or disposition, for example, a part as detection or measurement to sample.It can be for example at described herein Sample is transported in what vessel or device.In embodiments, sample reception place may include one or more sample treatment dresses It sets, the sample processing device can be used for handling or analyzing sample.Sample processing device can be for example in September 26 in 2011 The U.S. Patent Application Serial Number 13/244 that day submits, described in 947, or other pass through reference everywhere such as this paper Described in any other file being incorporated to.It, should during transport of the sample from sample collection place to sample reception place Sample can pass through any number of position.In embodiments, first position can be sample collection place, and the second position It can be sample reception place.

With reference to Figure 44, an embodiment of body fluid sample collection and transport will now be described.Figure 44 is shown positioned at tested Humoral sample B on the skin surface S of person.In the non-limiting example of Figure 44, humoral sample B can be by a variety of devices One kind is collected.For lifting non-limiting example, collection device 3530 can be but not limited to submit on September 6th, 2012 U.S. Patent Application Serial Number 61/697, collection device those of described in 797, the document by reference full text simultaneously Enter this for all purposes.In the present embodiment, humoral sample B is collected by one or more capillary channels, and then It is directed in sample vessel 3540.For lifting non-limiting example, at least one sample vessel in sample vessel 3540 can With the inside being initially under partial vacuum, for humoral sample to be sucked into sample vessel 3540.Some embodiments Sample can be sucked into sample from sample collection device from the identical or different collection channel in sample collection device simultaneously In vessel 3540.Optionally, some embodiments can suck the sample into simultaneously into sample vessel.

In the present embodiment, after humoral sample is in sample vessel 3540, will be located in its retainer 3542 The sample vessel 3540 of (or optionally, removing from its retainer 3542) are loaded into shipping container 3500.In the embodiment party In formula, there may be the one or more slots being dimensioned to for sample vessel holder 3542, or hold for transport The slot of sample vessel in device 3500.Lift non-limiting example for, the slot can by array configuration accommodate sample vessel and It is oriented vertical or some other scheduled orientations.It should be appreciated that some embodiments of sample vessel 3540 are configured to So that they accommodate different amounts of sample in each vessel.For lifting non-limiting example, this can be based on each sample The sample size collected in the amount of vacuum power in vessel, one or more sample collection channels of collection device and/or its His factor and controlled.Optionally, there may also be different pretreatments in sample vessel, such as, but not limited to different Anti-coagulants etc..

As seen in Figure 44, sample vessel 3540 are received just at first position (such as, but not limited to sample collection place) Collect sample.For lifting non-limiting example, humoral sample is then transported to the second position in shipping container 3500, this second Position such as, but not limited to reception site, such as, but not limited to analysis place.Transportation resources can be through express delivery, postal speed It passs or other transportation technologies.In many embodiments, can by have the another container that is accommodated therein shipping container come Realize transport.In one embodiment, sample collection place can be point-of care.Optionally, sample collection place is service Point.Optionally, sample collection place is far from sample analysis place.

Although Figure 44 this embodiment illustrates the collection from the surface of subject to humoral sample, other are alternative The collection technique for collecting sample from other regions of subject can be used in embodiment, such as by venipuncture, to fill out Fill one or more sample vessel 3540.Be not excluded for other such collection techniques be used for as the alternative of surface collection or with Surface collection is used in combination.Surface collection can be on the outer surface of subject.Optionally, some embodiments can be from tested In person's body can and surface be collected.The presence of humoral sample B on these surfaces with Lock-in or can pass through Wound create or make body fluid surface can and other technologies and occur.

Referring now to Figure 45, another embodiment there is described herein, wherein coming together on the surface of subject compared to collecting Sample, humoral sample can be collected out of subject body.Figure 45 the embodiment show with hypodermic needle 3552 Collection device 3550, which is configured for collecting humoral sample, such as, but not limited to venous blood.? In one embodiment, humoral sample can be with the room 3554 in filling device 3550, at this point it is possible to engage one or more samples Product vessel 3540 are to suck the sample into corresponding one or more vessel.Optionally, some embodiments can not have room 3554, but in addition to for guiding the one or more to one or more sample vessel 3540 to lead to from needle 3552 in sample There is very small spare space except road, one or more accesses or one or more pipes.For humoral sample such as blood Liquid, be from endovascular pressure so that blood sample can with filled chamber 554 without from collection device it is very much (if If having) auxiliary.Such embodiment can optionally include one or more discharge orifices, such as, but not limited to port, Air is allowed to escape when being filled to the channel in collection device by sample.

At least some or all embodiments can have pad indicator, such as, but not limited to watch window or opening, Show when sample is present in collection device and thereby indicates that the one or more sample vessel 3540 of engagement are acceptable 's.Optionally, however not excluded that the embodiment without pad indicator.After reaching desired fill level, it can incite somebody to action The sample vessel 3540 that one or more is filled are disconnected from sample collection device.It is alternatively possible to by one or more additional Sample vessel 3540 be bonded to sample collection device 3550 (or 530), to collect the humoral sample of additional quantity.

Figure 46 shows the further embodiment of sample collection device 3570.The embodiment described herein has Tissue penetration part 3572 such as, but not limited to has and holds the hypodermic needle for holding part 3574.It holds and holds part 3574 and can promote The positioning of tissue penetration part 3572 reaches desired depth and position more accurately to enter patient.In the present embodiment, One or more sample collection vessel 3540 are located at not and in the carrier 3576 of 3572 direct physical contact of tissue penetration part. Fluid connection channels 3578, such as, but not limited to flexible pipe can be used for tissue penetration part 3572 and one or more samples Product collection vessel 3540 is connected.Some embodiments have sample vessel 3540 as one or more: the sample device Ware 3540 is configured to slidably, to be only just in fluid communication under control of the user with tissue penetration part 3572.At least one A little or all embodiments can have pad indicator, such as, but not limited to watch window or opening, when show sample It is present in collection device and thereby indicates that the one or more sample vessel 3540 of engagement are acceptable.Optionally, it does not arrange Except the embodiment without pad indicator.Some embodiments can optionally include one or more discharge orifices, such as But it is not limited to port, allows air to escape when being filled to the channel in collection device by sample.In most of embodiment party It, can be by the sample vessel 3540 that be filled of one or more from sample collection after reaching desired fill level in formula Device disconnects.It is alternatively possible to one or more additional sample vessel 3540 are bonded to sample collection device 3570, with Collect the humoral sample of additional quantity.

Sample treatment

Referring now to Figure 47, shows in figure and unloaded in it after reaching destination locations by unloading assembly 3600 The system view of tolerant shipping container 3500.In one embodiment, by cover board 3502 be positioned at release position it Afterwards, the sample vessel being located therein can be removed from vessel 3500.For lifting non-limiting example, the removal can pass through It removes the entire pallet of sample vessel, remove the retainer of multiple sample vessel from pallet and/or by individually removing Sample vessel and carry out.Robot control structure 3602 can be used in some embodiments, and the robot control structure 3602 can It is vertically moved as indicated by arrow 3604 and/or as indicated by arrow 3606 along cross gauntry 3608 move horizontally, to remove sample vessel from shipping container 3500.Programmable processor 3610 can be used to be used for control Manipulate the position of the structure 3602 of sample vessel.In one embodiment, structure 3602 includes magnet, and the magnet is for connecing Retaining mechanism is closed, to remove pallet from structure 3602.It is not excluded for using mechanical arm and/or other kinds of programmable manipulator Other embodiments, and the purposes of this paper can be configured to.

In embodiments, when wrapping sample vessel with sample and reaching the position for being used for processing or the analysis of the sample, Sample can be removed from sample vessel.It can be in the preceding processing for removing sample from sample vessel (for example, shaking, rotation, mixing Or centrifuge separation) sample vessel.Sample can be removed from sample vessel by any mechanism appropriate, the mechanism is all for example It draws (for example, being drawn by fluid handling system or pipettor), topple over or mechanical force is (for example, by reducing inside sample vessel The size in region to extrude sample from vessel).In embodiments, seldom or do not have when removing sample from sample vessel Sample remains in vessel (for example, as machinery/transfer indfficiency).For example, being less than or waiting after removing sample from vessel It is likely to remain in sample vessel in the sample of 50l, 40l, 30l, 20l, 15l, 10l, 5l, 4l, 3l, 2l, 1l or 0l.

It, can be then using such as on September 26th, the 2011 U.S. Patent application sequences submitted for lifting non-limiting example System described in row number 13/244,947 handles the sample in sample vessel, and the document is incorporated by by reference For all purposes in this.It can be by the U.S. Patent Application Serial Number 13/244,946 such as submitted for 26th in September in 2011 Described in the mode for meeting CLIA carry out configuration analysis system, the document is incorporated by this by reference for owning Purpose.In embodiments, the sample that is transported according to system and method provided herein is reached for handling or analyzing It can be divided into two or more smaller parts when position, and various measurements can be carried out to sample.For example, in embodiment In, can carry out at least 1 to the sample that transports according to system and method provided herein, 2,3,4,5,6,7,8,9,10,20, 30,40 or 50 kind measurement.The measurement may include different types of measurement (for example, being used to measure protein, nucleic acid or thin Born of the same parents) and use one or more detection methods (for example, cell count, the luminous or method based on spectrophotometer).In reality It applies in mode, two or more sample vessel comprising the sample from single subject can be transported, wherein described two Or more sample vessel include the anti-coagulants different from sample mixes at least two (for example, a sample vessel include EDTA- sample and sample vessel include heparin-sample).Sample from EDTA- sample vessel can be subsequently used in heparin One or more measurements sensitive or that EDTA is insensitive.Similarly, it can be subsequently used in from heparin-sample vessel sample One or more measurements that EDTA is sensitive or that heparin is insensitive.In embodiments, according to system and method provided herein And the sample transported can be divided into two or more parts when arriving at the destination, and at 1,2,3,4,5,6,7,8,9,10 Or more analyzed on different sample analysers.

Referring now to Figure 49 to Figure 51, it should be understood that can be used according to system provided herein or method and prepare or transport To carry out list, (at least any two in the detection on Figure 49 to Figure 51) detect sample defeated, from subject.Example Such as, the humoral sample from subject can be used and carry out at least two detections in list, wherein be used to be detected The total volume of humoral sample is no more than 300 microlitres, and the humoral sample of the total volume from subject is having in liquid form It is transported in the sample vessel for having 400 microlitres or smaller internal capacity.In another example, the body from subject can be used Liquid sample and carry out at least two detections in list, wherein the total volume of humoral sample for being detected is no more than 300 microlitres, and the humoral sample of the total volume from subject is in liquid form in the first sample vessel and the second sample device It is transported in ware, each vessel have 200 microlitres or smaller internal capacity, and the first sample vessel include to be mixed with the first anti-coagulants Humoral sample and the second sample vessel include to be mixed with the humoral sample of the second anti-coagulants.In embodiments, it can be used and come from The humoral sample of subject and carry out list (on Figure 49 to Figure 51) at least 2,3,4,5,6,7,8,9,10,11,12,13, 14,15,20,25,30,35,40,50 or 60 kind detection, the humoral sample have not greater than or equal to 5ml, 4ml, 3ml, 2ml、1.5ml、1ml、750l、 500l、400l、300l、200l、150l、100l、75l、50 l、40l、30l、20l、10l、5l Or the total volume of 1l.The humoral sample of total volume can be stored in simple sample vessel or be transported from collection location to analysis Or processing position or its can be in 2,3,4,5,6,7,8,9,10,11,12,13,14,15,20,25 or more sample devices It is distributed between ware.When the totality of the humoral sample from single subject is integrated in two or more sample vessel, Sample part in some or each sample vessel may include different anti-coagulants or other additives.In this example, it comes from Humoral sample of the total volume of subject no more than 300 microlitres can be used for carrying out two or more detections, wherein no more than At least one portion of 300 microlitres of sample is mixed with the first anti-coagulants, and the second part of the sample no more than 300 microlitres is mixed There is the second anti-coagulants different from the first anti-coagulants.Optionally, each of the sample no more than 300 microlitres is partially in it certainly In oneself sample vessel.Optionally, two or more detections can be carried out, wherein no more than 300 microlitres of samples all in list It is transported in one vessel and includes single anti-coagulants.It is alternatively possible to which for all detections, total volume is used to be no more than 300 microlitres of the blood from subject come carry out in the list it is at least any three kinds detection.It is alternatively possible to use For all detections, blood from subject of the total volume no more than 300 microlitres carries out in the list at least Any five kinds of detections.It is alternatively possible to using for all detections, total volume no more than 300 microlitres from subject's Blood come carry out in the list it is at least any seven kinds detection.It is alternatively possible to using for all detections, total volume The blood from subject no more than 300 microlitres detects to carry out at least any ten kinds in the list.Optionally, may be used It is carried out in the list with using blood from subject of for all detections, total volume no more than 300 microlitres At least any 15 kinds of detections.It is alternatively possible to using for all detections, total volume coming from no more than 300 microlitres The blood of subject come carry out in the list it is at least any 20 kinds detection.For any of above situation, at least some In embodiment, at least one portion with the first anti-coagulants and second part has different from the second anti-of the first anti-coagulants Solidifying agent.

Referring now to Figure 52, the another embodiment of the device for body fluid sample collection is shown in figure.Figure 52 is shown Humoral sample B collected by collection device 3710, subject.As seen in Figure 52, collection device 3710 may include receiving Collect part 3712, such as, but not limited to capillary or other collection structures.The draw fluid wherein of collection part 3712, finally The fluid is guided towards the inner cavity of device 3,710 3714.It, can be such as figure after collection part 3712 has had collected desired amount Whole device 3710 is oriented shown in 52 like that, so that gravity can then suck the sample into cavity 3714.It is inciting somebody to action After all samples B is moved into cavity 3714, collection part 3712 can be removed from device 3710.In one embodiment, it moves It removes and replaces cap and collection part 3712 with closed cap 3718.In a non-limiting example, cap 3718 can be Thereon without the cap of any opening.Optionally, some embodiments can have partition or other closed openings in cap, Wherein can need not with different configuration of new cap to replace the cap in the case where remove collection part 3712.

Modularization sample collection device

Referring now to Figure 53 A- Figure 53 C, it is used for although sample collection device usually is described as having by embodiments described herein The adapter portion 3750 that sample collection part 3740 is connected with sample bomb ware 3760, it is to be understood that, however not excluded that There is no the embodiment of such configuration.

For lifting the non-limiting example in Figure 53 A, one or more adapter portions 3750 can be discrete component, Initially not with any one in direct fluid communication in collection part 3740 or sample bomb ware 3760.Here, collection part 3740 can be by between one or more of collection part, adapter portion 3750 or one or more vessel 3760 Relative motion mode (in order or simultaneously) and be connected to vessel 3760, with create from collection channel pass through described one A or multiple adaptor channels lead to the fluid passage in the vessel.

For lifting the non-limiting example in Figure 53 B, as previously proposed herein, some embodiments can be without dividing Vertical, individual adapter portion 3750.Here, collection part 3740 can by as indicated by arrow 3770 in these yuan The mode of the relative motion between one or both element in part and be connected directly to vessel 3760.In Figure 53 B Finding may exist fluid flow characteristics 3780, have one or complete as indicated by arrow 3782 in these elements Relative motion between two, portion element.In a non-limiting example, which can be engagement and receives Collect the cap of one end of part 3740, to promote fluid to flow into vessel 3760.Optionally, fluid flow characteristics 3780 can be With the cap for being shaped the front surface to engage collection part 3740.Optionally, fluid flow characteristics 3780 can be column Plug, bar and/or other devices to promote the flowing towards sample bomb ware 3760.Optionally, until sample collection When part 3740 gets out engagement vessel 3760, fluid flow characteristics 3780 are just fully engaged.It is alternatively possible to configure Embodiment so that from collection part 3740 to the flowing of sample bomb ware 3760 do not use fluid flow characteristics 3780, But instead based on different power, such as, but not limited to gravity, vacuum suction or fitting in collection part 3740 The blowing force provided at end.

For lifting the non-limiting example in Figure 53 C, 3740 conduct of collection part is can be used in one or more embodiments Storage vessel.Once having reached desired fill level, some embodiments can be covered simply with cap 3790 and 3792 entirely Portion both ends.As seen in the figure in Figure 53 C, cap 3790 and 3792 even can still be kept when part 3740 is in vertical orientation Fluid is in wherein.

For embodiments described herein, there may be variations and substitution, and should not be by any single implementation Mode is construed to comprising entire invention.For example, may exist two or more capillaries in collection part 3740.It is optional Ground, they can be each formed as discrete pipe or channel.Optionally, some embodiments can have public initial part but tool There is the outlet port of separation, such as, but not limited to Y shape configures.It should be appreciated that any embodiment of this paper can be modified to wrap Containing for the feature illustrated in the description of Figure 53 A- Figure 53 C.

Referring now to Figure 54, after sample vessel 3800 reach desired processing intent ground, the sample in vessel 3800 can Suitably prepared.In one embodiment, vessel 3800 are similar to vessel 3710.As seen in Figure 54, sample can handle Product with the whole portion that separates into processing unit, entrance such as, but not limited on cylinder casket 3802 and on another casket 3804 Another entrance.In one embodiment, two cylinder caskets 3802 are provided to the miniflow that blood chemistry detects and handles sample Body disc, blood chemistry detection is all for example but to be not limited to: comprehensive metabolic function group (Comprehensive Metabolic Panel)(ALB,ALP,ALT,AST,BUN,Ca,Cl-,CRE,GLU, K+,Na+,TBIL,tCO2,TP)；Basic metabolism function Group (Basic Metabolic Panel) (BUN, Ca, CRE, eGFR, GLU, Cl-, K+, Na+, tCO2)；Blood lipid group (Lipid Panel)(CHOL,HDL,CHOL/HDL,LDL,TRIG, VLDL,nHDLc)；Blood lipid group upgrade version (Lipid Panel Plus) (tCHOL, HDL, CHOL/HDL ratio, LDL, TRIG, VLDL, GLU, ALT, AST, nHDLc)；Liver group upgrade version (Liver Panel Plus)(ALB,ALP,ALT,AST,AMY, TBIL,TP,GGT)；Electrolyte group (Electrolyte Panel) (Cl-,K+,Na+, tCO2)；General chemistry (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 group (Renal Function Panel) (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-,K+,Na+,tCO2PHOS)； Metlyte(Cl-,K+,Na+,tCO2,BUN,CK,CRE,eGFR,GLU)；Renal function (Kidney Function)(BUN,CRE,eGFR)；Liver function group (Hepatic Function Panel) (ALB, ALP, ALT, AST,DBIL,TBIL,TP)；Basic metabolism functional group (Basic 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 group upgrade version (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,tCO2).It should be appreciated that other fluid processing techniques that may research and develop of future be also suitable for this paper at least It is used in one embodiment.In some embodiments, pipeline can be used that fluid is transported on such as, but not limited to cylinder casket Fluid receiving port the purpose of, sample is delivered to one or more general chemistry microfluids/centrifuge separation cylinder casket 3802 (and/or 3804).At least one or more other casket can also be used, such as, but not limited to as by quoting simultaneously Enter open fluid movable type cylinder casket described in the application of this paper, to improve available detection type.Although showing at least Two destination cylinder caskets, it is to be understood that, however not excluded that (such as shown in dotted line is attached for the embodiment with more than two cylinder casket Add shown in a casket).Fluid transport can by pipettor, pass through fluid line, microfluid or by future may research and develop its His fluid processing technique.

Referring now to Figure 55 A, it should be understood that the sample with one or more pipettors can be used in some embodiments Processing system is extracted sample from vessel 3800 in a manner of no pipe.Although describing one or more liquid reliefs in the embodiment Device, it is to be understood that, it is also suitable at least one implementation in this paper in other fluid processing techniques that future may research and develop It is used in mode.Figure 55 A shows the automated system that can be used for whole point of sample.It is also understood that in some embodiments In, before, during or after whole point, sample dilution may be present to increase the liquid volume of sample.This can be beneficial to various Purpose.Figure 55 A is also shown in some embodiments, sample can be delivered to one or more general chemistry microfluids/ It is centrifugated cylinder casket 3802 (and/or 3804).At least one or more other casket can also be used, such as, but not limited to such as It is incorporated by reference into open fluid movable type cylinder casket described in the application of this paper, to improve available detection type. Although showing at least two destinations cylinder casket, it is to be understood that, however not excluded that the embodiment with more than two cylinder casket is (such as Shown in additional cylinder casket shown in dotted line).Fluid transport can by pipettor, by fluid line, microfluid or by not Carry out other fluid processing techniques that may be researched and developed.Some embodiments can be used identical technology that sample is moved to a casket Perhaps one or more other purposes or optionally, the combination of one or more technologies can be used for some embodiments Mobile example.For by way of example, and not limitation, detection may involve the use of other detection techniques, such as, but not limited to A casket can be used to expand in ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemistry and/or other detection techniques 3806 analysis types carrying out, other than general chemistry detection.Alternatively, it should be understood that herein can be in company with from vessel 3800 systems for carrying out whole point are used together more than one cylinder casket 3802 and/or individually unit cylinder casket 3806.

Referring now to Figure 55 B, further embodiment is shown in figure, vessel 3800 are shown to be had in it Sample fluid.In one example, it can be in sample fluid wherein " pure " or undiluted.It is alternatively possible to match Some embodiments are set so that sample can be pre-processed in collection location and/or reception site, with dilute the sample and/ Or certain chemical material is provided into the sample.As seen in Figure 55 B, pipettor 3602 is can be used in the future in fluid handling system Other one or more vessel 3810,3812 and/or 3814 are assigned to from the sample of vessel 3800 is whole.Lift non-limiting example and Speech, these vessel 3810,3812 or 3814 can be vessel identical with vessel 3800.Optionally, they can be difference The vessel of type.Based on bar code or about the other information of sample, processor is programmed to determine be directed to sample at least one At least one desired number of a desired sample dilution and whole point of object.In the non-limiting example, by whole point of object It respectively transports to a sample treatment unit 3820,3822 and 3824.These processing units can all be the processing of same type Unit, each processing unit can be type different from each other or some processing units can identical and some processing unit It can be different.In at least one non-limiting example, sample treatment unit can be simple sample processor or can be same When handle the batch processing devices of multiple samples.

Figure 55 C shows further embodiment, wherein collecting sample in collection location and then keeping liquid in sample The second place is transported to while body form.Figure 55 C show with can from the single wound with subject collect Multiple vessel of sample.It is more that this allows subject's offer that can be handled in each vessel by different types of chemicals A sample.It can will may include sample from only one subject or from multiple samples of multiple subjects that Figure 55 C, which is shown, The shipping container of product is transported to the courier of reception site.Although showing mankind courier, it is to be understood that, however not excluded that machine Device people transport, unmanned plane or following other transportation technologies, system or the device that may be researched and developed are (including but not limited to sample One or more " virtual " version transport).In the non-limiting example, reception site can be by one or more vessel 1504 are loaded into from shipping container with can be in the cylinder casket of movable independently reagent unit and/or determination unit.It then can should Cylinder casket is loaded into one or more processing modules 701 to 707.These units can be identical module.Optionally, described At least one module in module is different from other modules.Similar to Figure 55 B, some embodiments may include processor 3830, The processor 3830 can will include the vessel 1504 or other one or more vessel of sample and/or prediluted sample Before being loaded into a casket, coordinate the sample from vessel 1504 dilution and/or whole point (based on vessel ID or other association Information).In at least one embodiment of this paper, each module can receive at least one casket and at least one sample device Ware.It is alternatively possible to place more than one sample vessel in each casket.Optionally, sample vessel may include inhomogeneity The sample of type, so that cylinder casket can have the sample for being loaded into more than one type therein.Optionally, some embodiments Can have and be directed to module of the receiving area of cylinder casket at least one for the receiving area of sample at least one.

Optionally, some embodiments can only be used for the position of receiving barrel casket with one, this tin casket then also includes At least one sample.In this way, the risk that user has to for individual object being loaded into module is reduced.One Denier loads, once configuring at least one embodiment of this paper so that sample is inserted into module, just there is no to sample The user of product manipulates.Once the non-limiting example can be used for just making to be associated in processed situation in the module in sample In the error minimization of human factor.

It is also understood that centrifugal force or other power can be used to come while handling multiple samples for some embodiments, by sample Product are reduced to precipitating level in sample vessel.In a non-limiting example, this can by pallet centrifuge (such as but Be not limited to 384 orifice plate centrifuges) mode and realize.

Figure 55 C show embodiment according to the present invention, have multiple module 701-706 and cell count station 707 System 700.The multiple module includes the first module 701, the second module 702, third module 703, the 4th module 704, the Five modules 705 and the 6th module 706.

Cell count station 707 is operably coupled to every in multiple module 701-706 by sample processing system 708 A module.As described herein, sample processing system 708 may include pipettor, and such as positive displacement, exhaust or assimilating type move Liquid device.

As above and described in other embodiments of the invention, cell count station 707 includes for holding to sample The cell counter of row cell count.Cell count station 707 can execute cell count to sample, and simultaneously in module 701-706 One or more modules to another sample execute other preparation and/or Dosimetry.In some cases, cell count station After 707 undergo sample preparation in sample one or more modules in module 701-706, cell is executed to sample It counts.

System 700 includes the support construction 709 with multiple positions (or erecting bed).The multiple position is used for mould Block 701-706 is docked to support construction 709.As shown, support construction 709 is rack.

Each module is fixed to rack 709 by means of attachment members.In one embodiment, attachment members are fastenings To module or the hook of platform position.In this case, which is configured among the socket for sliding into module or platform position. In another embodiment, attachment members include fastener, such as screw fastener.In another embodiment, it is attached structure Part is formed by magnetic material.In this case, module and platform position may include the magnetic material of opposite polarity, in order to provide Module is fixed to platform position by attraction.In another embodiment, attachment members include one or more tracks in platform position Or guide rail.In this case, module includes for tying with one or more tracks or the one or more of guide rail cooperation Structure, so that module is fixed to rack 709.Optionally, power can be provided by guide rail.

Allowing the example of module and the structure of rack cooperation may include one or more pins.In some cases, The direct slave bridge joint of module receives power.In some cases, module can be in the internal power source for device power supply, such as lithium Ion battery or using fuel cell as the battery of power.In this example, module is configured to be cooperated by means of guide rail and rack, And the power of module arises directly from guide rail.In another example, module is (guide rail, pin, hook, tight by means of attachment members Firmware) cooperate with rack, but wirelessly power --- such as inductively (that is, inductively) --- is provided to module.? In some embodiments, pin is not necessarily required to the module of rack cooperation.For example, can be in module and rack or other branch Induction telecommunication is provided between seat.In some cases, wireless communication can be used, such as by means of ZigBee communication or its His communication protocol or the agreement that can be researched and developed in future.

Each module can be removed from rack 709.In some cases, a module can be used same, similar or different Module replacement.In one embodiment, the module is removed from rack and module is skidded off rack 709.In another reality It applies in mode, by torsion or rotating module to make the attachment members of module be detached from from rack 709, and is moved from rack 709 Except the module.Any electrical connectivity between module and rack 709 can be terminated from 709 remove module of rack.

In one embodiment, module is attached to rack and making module slide-in platform position.In another embodiment In, by torsion or rotating module to make the attachment members of module engage rack 709, and module is attached to rack.By mould Block, which is attached to rack 709 and can establish between module and rack, to be electrically connected.It is described electrical connection can be used for module or from Module provides power to rack or to device, and/or in module and other one or more modules or system 700 Communication bus is provided between controller.

It each of can occupy or be not take up rack position.As shown, all positions of rack 709 are occupied by module. However, in some cases, one or more platform positions of rack 709 are not occupied by module.In this example, the first module 701 has been It is removed from rack.In this case, system 700 can be operated without removed module.

In some cases, platform position can be configured for the son that containment system 700 is configured to module type to be used Collection.For example, platform position, which can be configured for receiving, can run agglutination determination rather than the module of cell counting measuring.Such In the case of, which can be " dedicated " in agglutination.Agglutination can be measured in several ways.Measure sample turbidity when Between dependent change be a kind of method.It can be by with light irradiating sample and with optical sensor (such as photodiode or phase Machine) 90 degree of reflected light is measured to realize this method.Over time, it is scattered due to more light by sample, it is measured Light will will increase.The time dependence variation for measuring transmissivity is another example.In the latter case, this can pass through irradiation Sample in vessel simultaneously measures the light across sample with optical sensor (such as photodiode or camera) to realize.At any time Between elapse, due to sample be aggregated, measured light can decrease or increase (for example, depend on agglutination material be held in it is outstanding It is precipitated out in supernatant liquid or from suspension).In other cases, platform position can be configured for containment system 700 and be configured At all types of modules to be used, range is from measuring station to support electrical system.

Each module can be configured to mutually independently function (or execution) with other modules.In this example, the first mould Block 701 is configured to and the second module 702, third module 703, the 4th module 704, the 5th module 705 and 706 phase of the 6th module Independently execute.In other cases, module is configured to execute together with other one or more modules.In such feelings Under condition, module can support the parallel processing of one or more samples.In this example, the same of sample is prepared in the first module 701 When, the second module 702 is measured same or different sample.This can support the minimum to the intermodule downtime And elimination.

Support construction (or rack) 709 can have type of server configuration.In some cases, each size of rack It is standardized.In this example, the separation criteria between module 701-706 turns at least about 0.5 inch or 1 inch or 2 English Very little 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 English Very little or 12 inches of multiple.

Rack 709 can be with one or more module weights in supporting module 701-706.In addition, rack 709 has choosing Fixed center of gravity can lead to the rotation of rack 709 or overturning without generating so that module 701 (top) is installed in rack 709 The arm of force.In some cases, the center of gravity of rack 709 is arranged between the vertical midpoint of rack and the bottom of rack, vertically Center is from the bottom of rack 709 to the 50% of frame top.In one embodiment, such as along the bottom far from rack 709 Measured by the longitudinal axis in portion, the center of gravity of rack 709 is arranged in the bracket height measured from the bottom of rack 709 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 in place of 100%.

Rack can have multiple positions (or erecting bed), and described position is configured to receive one or more modules.Showing In example, there are six erecting beds for the tool of rack 709, for allowing each module in module 701-706 being installed to rack.One In a little situations, platform position is located on the same side of rack.In other cases, platform position is located on the alternate two sides of rack.

In some embodiments, system 700 includes electrical connectivity component, for module 701-706 to be electrically connected each other It connects.Electrical connectivity component can be bus, such as system bus.In some cases, electrical connectivity component also makes module 701-706 can communicate with one another and/or communicate with the controller of system 700.

In some embodiments, system 700 includes controller (not shown), for by one in module 701-706 A or multiple modules promote the processing of sample.In one embodiment, controller promote module 701-706 in sample and Row processing.In this example, controller commander sample processing system 708 provides sample in the first module 701 and the second module 702 Product, so that difference of the operation simultaneously to sample measures.In another example, controller commands sample processing system 708 in module Sample is provided in a module in 701-706, and also provides sample (for example, sample is limited to cell count station 707 A part of volume) so that cell count and other one or more sample preparation regulations and/or measurement to sample Concurrently carry out.In this way, system is minimum by the downtime between module 701-706 and cell count station 707 Change --- if being eliminated.

Each individual module in multiple modules may include sample processing system, for managing mould everywhere in individual module Block and measurement module provide sample and remove sample from it.In addition, in addition to for promoting the processing to sample by module And/or except the other assemblies of measurement, each module may include various sample treatments and/or measurement module.The sample of each module Product processing system can be separated with 708 phase of sample processing system of system 700.Also that is, sample processing system 708 to from module 701-706 shifts sample, and the sample processing system of each module to from including the various sample treatments in each module And/or measurement module shifts sample.

In the example of Figure 55 C, the 6th module 706 includes sample processing system 710, which includes Assimilating type pipettor 711 and positive displacement pipettor 712.6th module 706 includes centrifuge 713, spectrophotometer 714, nucleic acid Stand 715 and PMT 716 for measurement (such as, polymerase chain reaction (PCR) measures).The example of spectrophotometer 714 is in Figure 55 C It is shown in (see below).6th module 706 further includes a casket 717, this tin casket 717 is the multiple for keeping multiple tips Tip is used to promote the sample transfer to each processing or measurement module from the 6th module.

In one embodiment, assimilating type pipettor 711 includes one or more perhaps 2 or more or 3 A or more perhaps 4 or more perhaps 5 or more perhaps 6 or more or 7 or more, Perhaps 8 or more perhaps 9 or more perhaps 10 or more perhaps 15 or more or 20 Or more perhaps 30 or more perhaps 40 or more or 50 or more.In this example, it draws Formula pipettor 711 is 8 pipettors with eight heads.Assimilating type pipettor 711 can be such as other implementations of the invention As described in mode.

In some embodiments, positive displacement pipettor 712 have 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 the smaller coefficient of variation.The change Dynamic coefficient is determined according to σ/μ, wherein " σ " is standard deviation, and " μ " is the average value in entire sample measurement.

In one embodiment, all modules are mutually the same.In another embodiment, at least some modules are each other It is different.In this example, the first, second, third, fourth, the 5th and the 6th module 701-706 includes positive displacement pipettor and suction Modus ponens pipettor and various measurements, such as nucleic acid determination and spectrophotometer.In another example, in module 701-706 At least one can have the measurement and/or sample preparation station different from other modules.In this example, the first module 701 includes Agglutination determination but do not include nucleic acid amplification assay, and the second module 702 includes nucleic acid determination but does not include agglutination determination.Module It can not include any measurement.

In the example of Figure 55 C diagram, module 701-706 includes that identical measurement and sample preparation (or manipulation) are stood.So And in other embodiments, each module includes any number and combination of measurement described herein and treating stations.

Module can be stacked vertically or horizontally relative to each other.If two modules along be parallel to, it is substantially parallel In or be nearly parallel to acceleration of gravity vector plane orientation, then they are about oriented perpendicular to each other.If two moulds Block along be orthogonal to, be substantially normal to or be nearly orthogonal to acceleration of gravity vector plane orient, then they be about Horizontal orientation each other.

In one embodiment, module vertical stacking a, that is, module is in the upper surface of another module.Scheme in Figure 55 C In the example shown, rack 709 is oriented such that module 701-706 is vertically installed relative to each other.However, in other feelings Under condition, module is horizontally installed relative to each other.In this case, rack 709 can be oriented so that module 701- 706 can abreast level be located each other.

In the another embodiment of system 730, the system is shown with multiple modules 701 to 704.The embodiment party Formula shows horizontal arrangement, and wherein module 701 to 704 is installed to support construction 732, the transport device in the support construction 732 734 optionally can move along X axis, Y-axis and/or along Z axis, so that such as, but not limited to sample vessel, tip, test tube etc. Element moves in module and/or between the modules.For lifting non-limiting example, if module 701-704 is along orthogonal In, the plane that is substantially normal to or is nearly orthogonal to acceleration of gravity vector orientation, then they are about horizontal orientation each other 's.

It should be appreciated that module 701-704 can be all mutually the same module such as the embodiment of Figure 55 C.? In another embodiment, at least some modules are different from each other.In this example, first, second, third and/or the 4th module 701- 704 can be replaced by other one or more modules, other described modules can occupy the position for the module being replaced.Other Module can optionally provide different function, such as, but not limited to replace with one of module 701-704 one or more thin Born of the same parents' counting module 707, communication module, storage module, sample preparation module, slide preparation module, tissue preparation module etc..Example Such as, one of module 701-704, which can be replaced, provides one or more modules of different hardware configurations, such as, but not limited to There is provided thermal control storage room for incubating, the storage between detection and/or storage after a test.Optionally, mould is replaced The module of one or more of block 701-704 can provide the relevant function of non-measurement, such as, but not limited to be directed to system 730 Additional telecommunication apparatus, additional image or user interface facilities or secondary power source, such as, but not limited to battery, fuel electricity Pond etc..Optionally, the module of one or more of replacement module 701-704 can for additional disposable product and/or Reagent or fluid provide storage.It will be appreciated that though some embodiments, which are shown, is only mounted on support construction there are four module On, but the other embodiments for excluding that there is less or more module in configuration are not horizontally mounted from this.It is also understood that The configuration can also be run in the case where not each position or slot are by the occupied situation of module, especially a kind of wherein Or a plurality of types of modules are drawn in any scenes of more power than other modules and are run.It under such a configuration, should be by Guide the power to empty station position that can be used by the module that may draw more power than other modules.

It should be appreciated that module 701-706 can be all mutually the same module such as the embodiment of Figure 55 C.? In another embodiment, at least some modules are different from each other.In this example, first, second, third and/or the 4th module 701- 706 can be replaced by other one or more modules, other described modules can occupy the position for the module being replaced.Other Module can optionally provide different function, such as, but not limited to replace with one of module 701-706 one or more thin Born of the same parents' counting module 707, communication module, storage module, sample preparation module, slide preparation module, tissue preparation module etc..

It will be appreciated that though some embodiments are shown only, there are six modules to install on the support structure, but not from this The other embodiments with less or more module are excluded in horizontal and vertical installation configuration.It is also understood that described match Setting can also run in the case where not each position or slot are by the occupied situation of module, especially one or more wherein The module of type is drawn in any scenes of more power than other modules and is run.Under such a configuration, it should be directed to The power of empty station position can be used by the module that may draw more power than other modules.

Some embodiments can provide the system with multiple modules 701,702,703,704,706 and 707.It is such Embodiment can have may include one or more modules add-on module, one or more of modules provide different Hardware configuration, such as, but not limited to offer thermal control storage room for incubating, the storage between detection or after a test Storage.Optionally, the module of one or more of replacement module 701-704 can provide the relevant function of non-measurement, such as But be not limited to for system additional telecommunication apparatus, additional image or user interface facilities or secondary power source, such as but It is not limited to battery, fuel cell etc..Optionally, the module of one or more of replacement module 701-707 can be additional Disposable product and/or reagent or fluid provide storage.

It will be appreciated that though Figure 55 C shows seven module installations on the support structure, but not from installation configuration Exclude the other embodiments with less or more module.It is also understood that configuration can also not each position or Slot is especially drawn in the module of wherein one or more types than other modules all by running in the occupied situation of module It is run in any scene of more power.Under such a configuration, the power that should be directed to empty station position can be by may be than it The module that his module draws more power is used.

In some embodiments, module 701-706 by communication bus (" bus ") each other and/or with system 700 Controller communication, which may include the electronic circuit and group for promoting the communication between module and/or controller Part.Communication bus includes the subsystem that data are transmitted between the module and/or controller of system 700.Bus can make Each component of system 700 enters central processing unit (CPU), the memory (for example, internal storage, system cache) with system 700 With the communication of storage location (for example, hard disk).

Communication bus may include the parallel electric wire with multiple connections, or provide logic function as parallel electric total Any physical layout of line.Communication bus may include that parallel connection is connected with Bits Serial, and can with multiple spot (that is, it is electric simultaneously Connection) or daisy chain topology it is online, or by switch hub connection.In one embodiment, communication bus It can be first generation bus, second generation bus or third generation bus.Communication bus allow each module and other modules and/ Or the communication between controller.In some cases, communication bus supports communication between multiple systems, such as, with system Communication between 700 similar or identical multiple systems.

System 700 may include one or more universal serial bus, parallel bus or selfreparing bus.Bus may include master Scheduler, the master scheduler are controlled the data flows, such as go to or from module (for example, module 701-706), controller and/ Or the flow of other systems.Bus may include external bus, by external device (ED) and system be connected to main system board (for example, Mainboard)；And internal bus, the internal component of system is connected to system board.Internal component is connected to one by internal bus A or multiple central processing units (CPU) and internal storage.

In some embodiments, communication bus can be wireless bus.The communication bus can be Firewire (IEEE 1394), USB (1.0,2.0,3.0 or other), Thunderbolt or other agreements be (the existing or following research and development Agreement).

In some embodiments, one or more of the group of system 700 including being selected from comprising the following terms is total Line, these are as follows: media bus, computer automatic analysis and control (CAMAC) bus, industrial standard architectures (ISA) bus, Usb bus, Firewire, Thunderbolt, extension ISA (EISA) bus, low pin count bus, MBus, microchannel are total Line, multibus, NuBus or IEEE 1196, OPTi local bus, peripheral equipment interconnection (PCI) bus, Parallel Advanced Technology are attached Part (ATA) bus, Q- bus, S-100 bus (or IEEE 696), SBus (or IEEE 1496), SS-50 bus, STE are total Line, STD bus (be used for STD-80 [8-] and STD32 [16-/32-]), monobus, VESA local bus, VME bus, PC/104 bus, PC/104 Plus bus, PC/104 Express bus, PCI-104 bus, PCIe-104 bus, 1- line Bus, super transmission bus, mutual integrated circuit (I2C) bus, PCI Express (or PCIe) bus, serial ATA (SATA) are total Line, serial peripheral interface bus, UNI/O bus, SMBus, 2- line or 3- line interface, selfreparing elastic interface bus and its Variant and/or combination thereof.

In some cases, system 700 includes serial peripheral interface (SPI), is that the one or more of system 700 is micro- Interface between processor and peripheral assembly or I/O component (for example, module 701-706).SPI can be used for 2 or more A perhaps 3 or more perhaps 4 or more perhaps 5 or more perhaps 6 or more or 7 Or more perhaps 8 or more perhaps 9 or more perhaps 10 or more or 50 or more, or Person 100 or more SPI compatibility I/O components are attached to a microprocessor or multi-microprocessor.In other situations Under, system 700 includes RS-485 or other standards.

In one embodiment, the SPI with SPI bridge joint is provided, there is SPI bridge joint in parallel and/or series connection to open up It flutters.Such bridge joint allows total online one of many SPI components of selection SPII/O in the case where the chip that do not increase sharply selects. This is by application suitable control signal as described below to allow in the total online daisy chaining device or for device of SPI It carries out chip selection and realizes.However, it does not keep parallel data path, to not have between SPI component and microprocessor The daisy chain data of transmission in need.

In some embodiments, it is connected in microprocessor with parallel and/or serial (or series connection) topology multiple SPI is provided between SPII/O component and bridges component.The SPI bridges component and supports to use the parallel SPI of MISO and MOSI line, with And serial (daisy chain) the local chip selection connection (CSL/) towards other slave units.In one embodiment, originally The SPI bridge joint component that text provides solves the problems, such as associated any with the multi-chip selection for more slave units.Another In embodiment, SPI provided herein bridge joint component support 4 for 4 SPI enabled devices (CS1/-CS4/), 8, 16,32,64 or more one single chip selections.In another embodiment, SPI provided herein bridges component branch Hold 4 times of cascades with external address bus setting (ADR0-ADR1).In some cases, SPI bridge joint component provided herein mentions It has supplied to the energy for controlling or up to 8,16,32,64 or more general output bits of data are controlled Power.SPI provided herein bridge joint component support in some cases to for control or up to 8 of data, 16,32, The control of 64 or more general output bits, and it is logical to can be used for the device identification to main website and/or the diagnosis to main website Letter.

One embodiment can be used embodiment according to the present invention, there is main bridge joint and and SPI subordinate bridge of connecting The SPI bridge joint scheme connect.Spi bus is by adding local chip selection (CSL/), module selection (MOD_ in bridging to SPI SEL) enhanced with selection data input (DIN_SEL), so that it includes necessary system features and inessential for allowing to add Various system features including system features, the virtual chrysanthemum formula chain of cascade, the device chip selection of such as multiple slave units It connects the signal-count of module to module being maintained at acceptable level, to the support of module id and diagnosis and protect Hold non-SPI assembly communication while slave component compatible with embedded SPI keeps compatible and in module.Figure 55 C is shown The example of the SPI bridge joint of embodiment according to the present invention.SPI bridge joint includes internal SPI control logic, control deposit Device (as shown, be 8) and respectively output and input pin.

Each subordinate bridge joint is connected to main website (also known as " SPI main website " or " main bridge joint ") in simultaneously arranged in series. The MOSI pin of each subordinate bridge joint is connected to the MOSI pin of main bridge joint, and the MOSI pin of subordinate bridge joint is connected to each other. Similarly, the MISO pin of each subordinate bridge joint is connected to the MISO pin of main bridge joint, and the MISO pin of subordinate bridge joint It is connected to each other.

Each subordinate bridge joint can be the group in module (for example, one in the module 701-706 of Figure 55 C) or module Part.In this example, the first subordinate bridge joint is the first module 701, and the second subordinate bridge joint is the second module 702, and so on. In another example, the first subordinate bridge joint is the component of module.

At least one non-limiting example can be used embodiment according to the present invention, have module interconnected The modular assembly figure of pin and main bridge joint and the various components of subordinate bridge joint.Embodiment according to the present invention, subordinate bridge joint can It is connected to main bridge joint.The MISO pin of each subordinate bridge joint is electrically connected with the MOSI pin of main bridge joint.Each subordinate bridge joint MOSI pin is electrically connected with the MISO pin of main bridge joint.First subordinate bridges the DIN_SEL pin on (left side) and the first subordinate bridges MOSI pin be electrically connected.The DOUT_SEL pin of first subordinate bridge joint and the DIN_SEL pin of the second subordinate bridge joint (right side) It is electrically connected.By making the DIN_SEL pin of each additional subordinate bridge joint enter the DOUT_SEL pin bridged with previous subordinate Electric connection, can connect additional subordinate bridge joint as the second subordinate.In this case, subordinate is bridged with and is connected Configuration connection.

In some embodiments, when asserting module selection line (MOD_SEL), it is led to the SPI bridge joint of connection CLK pulse capture is displaced to the state of the position DIN_SEL in bridge joint.DIN_SEL numbers correspond to and SPI chain of connecting The number for the module that road links together.In one example, if two modules with and arranged in series (for example, RS486 it) connects, then the number of DIN_SEL is equal to 2.

In one embodiment, the SPI bridge joint that " 1 " is latched during module selects sequence becomes " chosen module ", 8 control words are received during being provided in subsequent component selection sequence.Each accessible up to 4 cascades of SPI bridge joint SPI slave unit.In addition, each SPI bridge joint can have 8 GP receiving ports and 8 GP transmission ports." component choosing Select " sequence 8 words of write-in into " chosen module " SPI bridge joint control register, to support the subsequent thing with specific SPI device Business bridges GPIO port read write data via SPI.

In one embodiment, by asserting local chip selection line (CSL/) and then by the data of MOSI transmission First byte clock of word is input in control register and carries out component selection.In some cases, the lattice of register are controlled Formula is CS4 CS3 CS2 CS1 AD1 AD0R/W N.In another embodiment, the second byte is transmission or reception data. When CSL/ is deasserted, circulation is completed.

In SPI affairs, after selecting sequence with component, start subsequent SPI subordinate data transactions.(it can by SPICS/ One of referred to as SS/) be routed to 4 possible bridge-sets according to the true state of CS4, CS3, CS2 or CS1.Wire jumper position AD0, AD1 are compared with AD0, AD1 of control register, allow up to 4 SPI bridge joints in module.

One embodiment shows the device of embodiment according to the present invention, has the communication for being mounted on device Multiple modules of the SPI chain road of bus.3 modules are shown in figure, that is, module 1, module 2 and module 3.Each module packet Include one or more SPI bridge joint, one or more SPI bridge is used to making each component of module to be electrically connected into SPI link It connects, including the master controller (including one or more CPU) being electrically connected with SPI link.Module 1 includes bridging 00, SPI with SPI Bridge joint 01, SPI bridge multiple SPI slave units that each of 10 and SPI bridge joint 11 is electrically connected.In addition, each module Including receiving recording controller, transmission recording controller and module I D jumper wire device.

In other embodiments, module 701-706 is configured to be communicated with one another by means of wireless communication bus (or interface) And/or it is communicated with one or more controllers of system 700.In one example, module 701-706 is by means of wireless communication Interface communicates with one another.In another example, one or more modules in module 701-706 by means of wireless communication bus with The controller of system 700 communicates.In some cases, between module 701-706 and/or one or more controllers of system Only bus is communicated by wireless communication.It can be advantageously excluded in this way in the platform position for receiving module 701-706 The demand of wireline interface.In other cases, system 700 includes wireline interface, which wirelessly connects with system 700 Mouth cooperates.

Although system 700 has single-rack as shown in the figure, system (such as system 700) can have multiple racks. In some embodiments, system have 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.One In a embodiment, system has the multiple racks installed among side-by-side configuration.

In some embodiments, sample is provided to the system with one or more modules, such as Figure 55 C by user System 700.The sample is provided to the sample collection module of system by user.In one embodiment, sample collection module Including one or more lancets, syringe needle, micropin, vein haemospasia device, scalpel, cup, swab, detergent, bucket, basket, work Tool packet, permeable base or other described any other sample collecting mechanisms or method everywhere herein.Next, system will Sample is from sample collection module booting to one or more processing modules (for example, module 701-706) so as to the sample system of progress Standby, measurement and/or detection.In one embodiment, by means of sample processing system, such as pipettor, by sample from acquisition Module booting is to one or more of processing modules.Next, handling sample in one or more of modules.One In a little situations, sample is measured in one or more modules, and detect routines in being then subjected to one or more.

In some embodiments, after being handled in one or more modules, result is transmitted to and is somebody's turn to do by system The user of system communication or system (for example, server).Other systems or user can then take the result to help to treat Or diagnosis subject.

In one embodiment, system configuration is used for and other systems --- such as similar or same system (example Such as, rack, the rack such as described under the background of Figure 55 C) or other computer systems including server --- into Row two-way communication.

Device and method provided herein are by supporting parallel processing that can advantageously reduce the energy of service dot system Footprint or carbon footprint.In some cases, the footprint having is other services to system --- system 700 of such as Figure 55 C --- At most the 10% of dot system 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%.

In some embodiments, the method for testing and analyzing object is provided.In one embodiment, example is handled Journey includes testing and analyzing the presence or missing of object.The handling routine is promoted by means of system provided herein and device. In some cases, analyte is associated with the rank of bioprocess, physiology course, environmental condition, sample situation, illness or illness Section, such as autoimmune disease, obesity, hypertension, diabetes, neuron and/or muscular-degenerative disease, heart disease With it is one or more among endocrine system disease.

In some cases, one sample of device single treatment.However, system configuration provided herein is used for multiple sample Product processing.In one embodiment, device is primary or with the multiple samples of the time-triggered protocol of overlapping.In one example, user Sample is provided to the device with multiple modules, the system 700 of such as Figure 55 C.The device is then by means of the one of device A or multiple modules handle sample.In another example, multiple samples are provided to the device with multiple modules by user. The device then by handling the first sample in the first module while the second sample is handled in the second module, by Multiple modules handle sample simultaneously.

System can handle the sample or different types of sample of same type.In one embodiment, system is simultaneously Handle a part or multi-section point of same sample.If it is desire to the various measurements of same sample and/or detection scheme, then this It may be useful.In another embodiment, system handles different types of sample simultaneously.In one example, system In the disparate modules of the system, or in the single module with the treating stations for handling blood and urine sample, together When be located in regulating blood condition liquid and urine sample.

In some embodiments, a kind of for handling sample by service dot system (such as system 700 of Figure 55 C) The method of product includes: to receive detection criteria or parameter, and determine detection ordering or schedule based on the criterion.Detection Criterion is received from user, system or the server with service point system communication.The criterion can based on expectations or scheduled effect Fruit selects, these effects are such as are as follows: least time, cost, component uses, step and/or energy.Service dot system is pressed Sample is handled according to detection ordering or schedule.In some cases, feedback loop (coupling with sensor) makes service point system System can monitor the progress of sample treatment and keep or change detection ordering or schedule.In one example, if being System detects that processing consumes the time longer than predetermined time amount described in schedule, then system accelerates the processing Or any parallel processing of adjustment, such as sample treatment in another module of system.Feedback loop allows in real time or pseudo- In real time (for example, caching) monitoring.In some cases, feedback loop can provide allow reflect detect, can start or it is complete After another detection and/or measurement or sensing one or more parameters, cause subsequent detection, measurement, preparation step and/or The initial of other processes.Such subsequent detection, measurement, preparation step and/or other processes can automatic initial, without any Human intervention.Optionally, reflection detection is executed in response to measurement result.For lifting non-limiting example, if subscribed Reflection detection is then pre-loaded with for cylinder casket for measuring A and measuring the reagent of B.Measuring A is Preliminary detection, and it is anti-for measuring B Penetrate detection.If the result of measurement A meets the predetermined criterion of initial reflection detection, transported in a device with same sample Row measurement B.Device for planning scheme is accounted for a possibility that reflection detection with that will run.It can be completed in the result of measurement A Preceding some or all protocol steps for executing measurement B.For example, sample preparation can be fulfiled ahead of schedule on device.It is also possible to With the second sample operation reflection detection from patient.In some embodiments, device and system provided herein may include Component with same device so that can reflect detection a variety of different measurements and type.In some embodiments In, one of a variety of detections with clinical meaning as reflection detection scheme can be executed in single device provided herein Part, wherein executing identical detection with known system and method needs two or more individual devices.Therefore, originally The system and device that text provides can for example allow than known system and method faster and the reflection of less sample needed to examine It surveys.In addition, in some embodiments, for carrying out reflection detection with device provided herein, it is not necessary to know in advance by Which kind of reflection detection can be executed.

In some embodiments, service dot system can adhere to predetermined detection based on initial parameter and/or desired effects Sequence or schedule.In other embodiments, the schedule and/or detection ordering can be modified in real time.It can be with base It no longer to be run in situation, one or more additional processes to be run, the one or more that one or more detects Process, the one or more processes to be modified, one or more resources/component utilization rate modification, one or more detect Mistake or alarm condition, one or more resources and/or the unavailability of component, customer-furnished one or more are subsequent Input or sample, external data or any other reason, and modify schedule and/or detection ordering.

In some instances, can after providing one or more initial samples to device, to device provide one or Multiple additional samples.Additional samples may be from same subject or different subjects.Additional samples can be and initial sample The sample of same type or different types of sample (for example, blood, tissue).It can be handled on device one or more first Before beginning sample, additional samples are provided later and/or at the same time.Can be provided for additional samples relative to each other and/or The identical and/or different detection of initial sample or desired criterion.Additional samples can be with initial sample successively and/or parallel Processing.One or more components identical with initial sample can be used in additional samples, or different components can be used.Mirror In the situation that the one or more of initial sample detects, it may be necessary to or may not be needed additional samples.

In some embodiments, system is by means of sample collections such as lancet, scalpel or fluid acquisition vessel Module receives sample.System then loads or takes scheme, to execute one or more from multiple potential handling routines A handling routine.In one example, system loads centrifugation protocol and cell count scheme.In some embodiments, side Case can be loaded into sample processing device from external device (ED).Alternatively, scheme may be on sample processing device.It can be with base Scheme is generated in one or more desired criterion and/or handling routine.In one example, generation scheme may include life At the list of one or more subtasks for each input process.In some embodiments, each subtask will be by The single components of one or more devices executes.Generation scheme may also include sequence, timing and/or the distribution for generating list One or more resources.

In one embodiment, scheme provides the processing details or explanation specific to component in sample or sample.Example Such as, centrifugation protocol may include be suitable for predetermined sample rate the speed of rotation and processing the time, support sample with may and sample The separation dependent on density of the desired component of product existing other materials together.

Scheme includes in systems, such as included in the scheme repository of system, or from another with the system communication Retrieval in one system (such as database).In one embodiment, system and database server carry out one-way communication, should Database server is according to system to the request of one or more processing schemes and to system provider case.In another embodiment party In formula, system and database server carry out two-way communication, this is enabled a system to the specific place of database server upload user Routine is managed, for user or the other users to user's particular procedure routine may be used to use in the future.

Referring now to Figure 56 A and Figure 56 B, shipping container 4000 be can be configured for wherein comprising from multiple subjects Multiple humoral samples of (such as patient).In some embodiments, there are multiple devices of the sample from each subject Ware.Optionally, at least two samples in sample from same subject have different chemical pretreatments, such as but not It is limited to the different anti-coagulants in each vessel.Optionally, some embodiments, which can be used, has two or more separation Room vessel, wherein each room is configured for accommodating one of fluid sample separated with the fluid sample in another room Point.Some embodiments can include the sample from subject in single chamber vessel and/or multicell vessel.

As seen in Figure 56 A and Figure 56 B, each view of an embodiment of shipping container 4000 is shown, wherein Cover board 4010 has at least one countertop segment 4012, which is dimensioned to be engaged to shipping container 4000 In dimple 4020 on bottom, as seen in Figure 57 A, so that vessel 4000 can be Stackable.Shipping container 4000 There can be any feature described in the other embodiments herein for shipping container described herein.

Figure 57 B is shown may be present pallet 4030 in shipping container 4000, the pallet 4030 be it is fixed and/or Person can remove from shipping container 4000.In one embodiment, pallet 4030 is held in place by fixed device, fixation dress Set such as, but not limited to in the chassis of shipping container 4000 metal or magnetic part be aligned to form the magnetic of magnetic connection Property or metal part 4032.In some embodiments, the range of length and the length-width ratio of width in about 128:86 to 127:85 In.Optionally, length and the length-width ratio of width are in the range of about 130:90 to 120:80.Optionally, the length of pallet is about In the range of 130mm to 120mm, and width is in the range of about 90mm to 80mm.In some embodiments, the height of pallet Degree or thickness are in about 14 to 20mm range.Length-width ratio and/or size are configured for accommodating size setting for cooperating The pallet of other retainers on slot, dimple or plate centrifuge.In this way, entire pallet 4030 can be centrifuged to make The standby multiple samples being located therein.

As seen in Figure 57 A and 57B, pallet 4030 has multiple slots 4034, and the size of bracket groove 4034 is arranged for holding Receive at least one sample bomb ware.At least one portion 4040 of slot 4034 has first shape, and at least second part 4042 have the second shape different from first shape, wherein being only capable of being inserted into slot 4034 by desired orientation with sample vessel In mode fix the shape.As seen in Figure 58 B, one end is semicircle and the other end is asymmetrically shape.Pallet 4030 also plastic formed have notch 4036 or other shapes, so that pallet 4030 is only capable of being inserted into transport by an orientation In container 4000.It is also understood that pallet 4030 can be maintained in pallet so that user is without using tool or other supports It is not available its finger in the case where disc taking-out device and removes pallet from vessel 4000.This makes the least risk that user distorts Change.Pallet 4030 can be configured to still be held in shipping container 4000 and can even if when shipping container 4000 is inverted Resist the drawing of terrestrial gravitation.

Figure 59 A and Figure 59 B show another embodiment, wherein there are multiple slots 4100 in pallet 4102.Pallet tool There is different length-width ratio (closer to square) and the slot in pallet with multiple mouldings is to accommodate sample vessel.

In at least some embodiments, medical supplier's (or being its office worker in due course) can be sample collection person, Testing result recipient and/or and for both.For example, in one embodiment, health care professionals, such as but not It is limited to dentist, can be used as a part of dental operation or collects sample independently of dental operation.Optionally, some implementations Mode can be from the blood and/or saliva collection sample of the absorption of the dental operation from subject.The sample of collection can be in tooth It handles and/or is transported in section clinic and receive multiple samples reception position for processing.

In embodiments, system provided herein, humoral sample can be diluted used in device or method.In reality It applies in mode, humoral sample can be diluted before it is transported from first position to the second position.In embodiments, body fluid Sample can be diluted after it is transported from first position to the second position.In embodiments, humoral sample can its from First position is all diluted before and after transporting to the second position.In embodiments, humoral sample can be at it from first Set transport to after the second position and its in the second place be used to execute laboratory testing one or more steps it Before be diluted.Original humoral sample can 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 times." n times " dilution used herein means original The ratio that beginning sample is diluted --- for example, diluting 5 times of primary sample after the dilution with the 1/5 of its original concentration Concentration includes primary sample (that is, diluted sample includes sample with 1/5 concentration of sample concentration in primary sample)；It is similar Ground, the primary sample for diluting 500 times includes after the dilution primary sample with 1/500 concentration of its original concentration.Cause This, for example, if primary sample include 5mg protein/microlitre, and diluted 2 times, then diluted sample includes 2.5mg protein/microlitre.Humoral sample can be divided into any number of part, and various pieces can be diluted to different dilutions Degree, so as to handle original humoral sample to obtain multiple diluted samples, each sample has different dilutions.Cause This, for example, original humoral sample can be divided into 5 parts, 8 times of one of part of dilution, another part dilute 12 times, Another part dilutes 3 times, another part dilutes 400 times and another part dilutes 2,000 times.It can be continuously or in single step The dilution of sample is executed in rapid.Single step is diluted, a selected amount of sample and a selected amount of diluent can be mixed, To realize desired sample dilution.For serial dilution, the serial dilution individual two or more times of sample can be performed, To realize desired sample dilution.For example, can execute to the first of sample the dilution, and can by this first diluted one Part is used as the second diluted input material, to obtain the sample in selected dilute strength.

For dilution described herein, " primary sample " etc. refers to used when given dilution starts Sample.Therefore, although " primary sample " can be the sample (for example, whole blood) directly obtained from subject, may also include Any other sample of starting material as given dilution is (for example, processed or previously individual The sample diluted in dilution).

In some embodiments, the serial dilution of sample can execute as described below.Can by selected amount (for example, Volume) primary sample mixed with a selected amount of diluent, to obtain the first dilute sample.First dilute sample (and it is any Subsequent dilution sample) i) sample dilution factors will be included (for example, primary sample is diluted in the first dilute sample Multiple) and ii) primary quantity (for example, existing first after a selected amount of primary sample is merged with a selected amount of diluent The total amount of dilute sample).For example, 10 microlitres of primary sample can be mixed with 40 microlitres of diluent, to be had First dilute sample of 5 times of sample dilution factors (compared to primary sample) and 50 microlitres of primary quantities.Next, can will select The first quantitative dilute sample is mixed with a selected amount of diluent, to obtain the second dilute sample.For example, can be by 5 microlitres The first dilute sample mixed with 95 microlitres of diluent, to obtain having 100 times of dilution gfactors (compared to original sample Product) and 100 microlitres of primary quantities the second dilute sample.For each step in above-mentioned dilution step, can by primary sample, One or more dilute samples and diluent storage are mixed in the vessel of fluid isolation.Serial dilution can be as needed, Continue several steps, in the manner aforesaid to reach selected sample dilution level/dilution gfactor.For example, in reality It applies in mode, the U.S. Patent Application Serial Number 13/769,820 that can such as be submitted for 18th for 2 months in 2013 or other are each herein Carry out dilute sample like that described in any other file that place is incorporated by reference into.

As used herein, as " diluent " or can be used as " diluent " reagent be for example facilitate increase sample The volume of a part of product or sample, or facilitate the preparation of liquid preparation (preparation such as rebuild after freeze-drying), or Person is used to add to the reagent of sample, solution or material for any other reason.In embodiments, diluent can be delayed Punching is (for example, to have close to pH 7 or and to can be pharmaceutically acceptable close to the pH of pH 7.4 or other expectations pH) (for the mankind administration be safe and nontoxic).Diluent usually not in sample analyte response or combination.Water can To be diluent, aqueous brine solutions, buffer solution are also possible to containing the solution of surfactant or any other solution Diluent.Exemplary thinning agents include sterile water, injection bacteriostatic water (BWFI), pH buffer solution (for example, phosphate-buffered Salt water), sterile saline solution, Ringer's solution or dextrose solution.In embodiments, diluent may include the water-soluble of salt Liquid or buffer.

In embodiments, such as according to system provided herein or method and from subject collecting, processing or fortune Defeated humoral sample or part thereof can be divided 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 piece.Sample is divided into for provided herein For the description of multiple portions, " primary sample " etc. refers to the used sample when given sample assigning process starts.Cause This may also include use although " primary sample " may, for example, be the sample (for example, whole blood) directly obtained from subject Make any other sample of the starting material of given sample assigning process (for example, processed or previous independent Sample assigning process in the sample that distributes).In embodiments, " primary sample " can be subjected to sample distribution and dilution step； In this case, " primary sample " is mentioned to refer to for combined sample dilution/sample assigning process starting material.When When sample is divided into different piece, the different piece may include different amounts of primary sample.For example, if there are 100 microlitres of bodies Long-pending primary sample is divided into 5 parts, then a part may include 50 microlitres of primary sample, and another part may include 25 micro- The primary sample risen, another part may include 15 microlitres of primary sample, and another part may include 8 microlitres of primary sample, with And last part may include 2 microlitres of primary sample.Similarly, when sample had not only been diluted but also had been divided into different piece, The different piece can have different dilutions relative to primary sample.For example, if primary sample is divided into three parts, Then a part can dilute 5 times relative to primary sample, and another part can dilute 20 times, and third relative to primary sample Part can dilute 200 times relative to primary sample.

Therefore, in this example, humoral sample can be collected from subject at first position (for example, sample collection place). Initially it can be considered as " primary sample " from the humoral sample that subject collects.Such " primary sample ", which for example can be, to be come From a small amount of (such as less than 400,300,200 or 100 microlitres) whole bloods of subject.Collected from subject " primary sample " it Afterwards soon or at the same time, " primary sample " can be divided at least first part and second part, hereafter turns first part It moves on in the first vessel and second part is transferred in the second vessel.In embodiments, the first vessel may include first Anti-coagulants (such as EDTA) and second part may include the second anti-coagulants (such as heparin).Can according to system provided herein or Method transports the first and second vessel to the second position from first position.In embodiments, described in the second place Sample or part thereof in one of vessel or whole the two can be subjected to further processing or analytical procedure.For example, described Sample or part thereof in one of vessel or whole the two can be divided into extention, be diluted and/or for execute it is a kind of or A variety of detections.

In another example, humoral sample can be according to system and method provided herein and from first position in vessel It is transported to the second position.Humoral sample in vessel can be the whole samples collected from subject or part of it. In the second place, at least some of vessel humoral sample can be removed from vessel, and be used for sample distribution and/ Or dilution.It is removed from vessel and the sample for being used for sample distribution and/or dilution can be considered as " original sample Product ".The primary sample for example can be whole blood, blood plasma, serum, saliva or urine, and may make up the sample transported in vessel Whole or part of it.The primary sample can be divided into any number of part；Various pieces can have relative to primary sample There is different dilutions.For example, from transport vessel the primary sample that removes can have 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 microlitres of volume. From transport vessel the primary sample that removes can then be divided 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 pieces.In embodiments, The different piece can have different dilutions relative to primary sample.For example, different piece can have relative to primary sample There are at least 2,3,4,5,6,7,8,9,10,15,20,25,30,35,40,50,100,200,300,400,500,1000 or 5, 000 different dilutions, condition are that there is the number of the part of different dilutions to be no more than from part prepared by primary sample Sum.The different piece can have any kind of dilution relative to primary sample, for example, including without dilution, extremely Few 2 times of dilutions, at least 3 times dilutions, at least 5 times dilutions, at least 10 times dilutions, at least 20 times dilutions, at least 50 times dilutions, extremely Few 100 times of dilutions, at least 500 times dilutions, at least 1000 times dilutions, at least 5000 times dilutions, at least 10,000 times dilutions, extremely Few 50,000 times of dilutions or at least 100,000 times dilutions.In embodiments, one or more different pieces of primary sample It can be used for laboratory testing.In embodiments, a part of primary sample can be used for a kind of laboratory testing.For reality The a part for testing the primary sample of room detection can be diluted sample.

In embodiments, primary sample can be the whole blood sample obtained from subject.Primary sample can be from subject Finger/toe obtain.Primary sample can have 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 microlitres of volume.Primary sample can be divided into multiple portions.Sample is divided into multiple portions Divide to betide and is transported the sample to before the second position, later from first position according to system provided herein or method Combination before and after or.In embodiments, primary sample can be divided 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 piece, and And the different piece for execute 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 kind of different laboratory testing.The different piece of primary sample can have dilution Primary sample.In embodiments, each laboratory testing use 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 microlitre of primary sample.

In embodiments, primary sample can be the blood plasma or serum obtained from the whole blood sample for being obtained from subject.Entirely Blood can be obtained from finger/toe of subject.The whole blood for therefrom obtaining blood plasma or serum can have 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 microlitres of volume.Blood plasma or blood Clear primary sample can have 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 microlitres of volume.Primary sample can be divided into multiple portions.Sample, which is divided into multiple portions, can betide basis System or method provided herein transport the sample to before the second position from first position, later or before and after Combination.In embodiments, primary sample can be divided 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 piece, and the different piece For execute 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 kind of different laboratory testing.The different piece of primary sample can have diluted primary sample.

In embodiments, use 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, equivalent (equivalent) Lai Jinhang laboratory testing of 0.2,0.1,0.05 or 0.01 microlitre of primary sample.For example, If primary sample is whole blood, and the primary sample is divided into multiple portions, and at least one portion includes diluted Sample, the diluted sample include to have diluted 100 times of primary sample, and use 5 microlitres of the diluted sample Product execute laboratory testing, then carry out the detection (5 using the equivalent of 0.05 microlitre of primary sample (for example, whole blood) Microlitre x1/100 dilution).In another example, primary sample can be whole blood.The whole blood be can handle to obtain blood plasma [for example, by the way that the liquid component of blood is mutually separated with the solid component (for example, cell) of blood].It can be from certain volume Whole blood obtain certain volume blood plasma --- for example, the volume for the blood plasma that can be obtained from the whole blood of certain volume for example may be used Be volume of whole blood at least or about 30%, 40%, 50%, 60% or 70%.Therefore, for example, if coming from whole blood Blood plasma volume be 50%, then the blood plasma of 1ml can be obtained from the whole blood of 2ml.It can further dilute from whole blood Blood plasma, and the diluted part of one or more of blood plasma can be used to execute one or more laboratory testings.Another In example, primary sample can be whole blood.Whole blood can be handled to obtain blood plasma, wherein the volume of the blood plasma from whole blood is complete 60% (for example, obtaining 60 microlitres of blood plasma from 100 microlitres of whole bloods) of blood.Blood plasma can dilute 10 times.2 microlitres dilute can be used The blood plasma released executes laboratory testing.Therefore, (complete using about 0.33 microlitre of primary sample for the laboratory testing Blood) equivalent execute the detection (2 microlitres of 100/60 whole blood of x1/10 dilution x/blood plasma conversion ratios).In another example In, primary sample can be blood plasma, and the primary sample can be divided into multiple portions, and at least one portion includes dilute The sample released, the diluted sample include to have diluted 50 times of primary sample, and use the 4 microlitres diluted sample Product execute laboratory testing, then carry out the detection (4 using the equivalent of 0.08 microlitre of primary sample (for example, blood plasma) Microlitre x1/50 dilution).

In embodiments, primary sample can be divided 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 piece, and the different piece Can be used for execute 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 kind of different laboratory testing.In some embodiments, it at least prepares and the part to sample The sample part of the laboratory testing of execution as many (for example, in order to use primary sample to execute 10 kinds of laboratory testings, can incite somebody to action The primary sample is divided at least ten part, and each detection uses at least one part).In certain other embodiments, may be used To execute more than one laboratory testing with simple sample.For example, in embodiments, the optical property of sample can be measured (for example, cell count in blood sample), and same sample can be used then to measure the analyte in blood. Therefore, in some embodiments, primary sample can be executed more than the number from part prepared by same primary sample More laboratory testings (for example, 10 kinds of laboratory testings can be executed from the primary sample for being only divided into 8 parts).

When primary sample is divided into multiple portions, and the multiple part is for executing the inspection of two or more laboratories When survey, laboratory testing can be same type laboratory testing or they can be the inspection of different types of laboratory It surveys.For example, if primary sample is divided into 10 parts, and 10 parts are then used described respectively for laboratory testing The laboratory testing that each part in part carries out can be immunoassays.In another example, if primary sample is divided into 5 parts, and 5 parts are respectively for laboratory testing, then the laboratory carried out with each part in the part Detection can be the detection based on nucleic acid amplification.

In other cases, when primary sample is divided into multiple portions, and the multiple part is for executing two kinds or more When kinds of experiments room is detected, at least two laboratory testings can be different types of laboratory testing.For example, if original Sample is divided into 5 parts, and 5 parts respectively for laboratory testing, then 2 parts in the part can be used for 3 parts in immunoassays (for example, ELISA) and the part can be used for the detection based on nucleic acid amplification.

The humoral sample or part thereof transported according to system provided herein or method can be used for various types of experiments Room detection, such as immunoassays, nucleic acid amplification assay, general chemistry measurement or cell counting measuring.In embodiments, root The humoral sample or part thereof transported according to system provided herein or method can be used for for example submitting on 2 18th, 2013 U.S. Patent Application Serial Number 13/769,820 or institute in other any other files for being incorporated by reference into everywhere herein In any kind of measurement or laboratory testing of description.

In some embodiments, the humoral sample or part thereof transported according to system provided herein or method can It is used in immunoassays." immunoassays " used herein refer to analyte have affinity antibody come Any measurement of detection analysis object.Immunoassays for example may include Enzyme-linked Immunosorbent Assay (ELISA) measurement, and may include Based on competition and non-competing measurement.Term as used herein " antibody " refers to immunoglobulin molecules and immunoglobulin The immunoactive portions of molecule, that is, the antigen-binding unit comprising molecule of the antigen binding (" immune response " occurs with antigen) The molecule of (" Abu " or plural " Abus ").In structure, simplest naturally occurring antibody (for example, IgG) includes more than 4 Two weight (H) chains of peptide chain-and two light (L) chain, interchain are connected by disulfide bond.Immunoglobulin represents a large family Molecule comprising the molecule of several types, such as IgD, IgG, IgA, IgM and IgE.Term " immunoglobulin molecules " includes, For example, hybrid antibody or the antibody and its segment of change.Based on its molecular structure, antigen-binding unit can be roughly divided into " single Chain " (" Sc ") and " non-single-stranded " (" Nsc ") type.

Immunoglobulin molecules and its segment are also contained in term " antibody " and " antigen-binding unit ", can be It is the mankind, non-human (be originated from vertebrate or invertebrate), chimeric or humanization.Chimeric is resisted with humanization The description of the concept of body, referring to Clark et al., 2000 and in bibliography (Clark, (2000) wherein quoted Immunol.Today 21:397-402).In embodiments, " immunoassays " as provided herein, which may also include, wherein wants The analyte measured in the assay is antibody, and with molecule (such as the target of the antibody to the antibody with affinity Molecule) detect the measurement of the antibody.

In some embodiments, the humoral sample or part thereof transported according to system provided herein or method can It is used in nucleic acid amplification assay." nucleic acid amplification assay " used herein refers to that the copy number of wherein target nucleic acid can increase Measurement.Nucleic acid amplification assay such as may include at the amplification technique of mild variable temperatures, and including for example, such as polymerase The technologies such as chain reaction (PCR) and ring mediated isothermal amplification (LAMP).In general, nucleic acid amplification assay includes at least i) nucleic acid polymerization Enzyme, ii) can be with the primer and iii in conjunction with target nucleic acid sequence) the free core in the nucleic acid synthesized can be incorporated by polymerase Thuja acid.The amplification of target nucleic acid, all fluorescence that reaction is for example measured in a period of time of the mode can variously be detected Or turbidity.

In some embodiments, the humoral sample or part thereof transported according to system provided herein or method can It is used in general chemistry measurement.General chemistry measurement may include, for example, to basic metabolism functional group (Basic Metabolic Panel) [glucose, calcium, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), Kreatinin, blood urea nitrogen (BUN)] measurement, to electrolyte group (Electrolyte Panel) [sodium (Na), potassium (K), chlorination Object (Cl), CO2 (carbon dioxide, bicarbonate)] measurement, to the metabolic function group (Chem of 14 groups of Chem/comprehensively 14Panel/ Comprehensive Metabolic Panel) [glucose, calcium, albumin, total protein, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), kreatinin, blood urea nitrogen (BUN), alkaline phosphatase (ALP), Alanine aminotransferase (ALT/GPT), aspartate transaminase (AST/GOT), total bilirubin] measurement, to blood lipid overview/blood The survey of rouge group (Lipid Profile/Lipid Panel) [LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides] Determine, to liver group/liver function (Liver Panel/Liver Function) [alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate transaminase (AST/GOT), total bilirubin, albumin, total protein, gamma glutamyltransferase (GGT), lactic dehydrogenase (LDH), prothrombin time (PT)], alkaline phosphatase (APase), hemoglobin, VLDL gallbladder it is solid Alcohol, ethyl alcohol, lipase, pH, protoporphyrin zinc, bilirubin direct, blood grouping (ABO, RHD), lead, phosphate, hemagglutination Inhibition, magnesium, iron, iron intake, fecal occult blood etc., independent or any combination measurement.

In general chemistry provided herein measurement, in some instances, determined by one or more determination steps Analyte level in sample, the determination step are related to reacting for interested analyte and one or more reagents, cause The variation (for example, generating luminous, variation of reaction color etc. in the variation of reaction turbidity, reaction) that can be detected in reaction. In some instances, the property of sample is determined by one or more determination steps, the determination step is related to interested Sample is reacted with one or more reagents, causes the variation that can be detected in reaction (for example, the variation of reaction turbidity, reaction It is middle to generate luminous, variation of reaction color etc.).In general, " general chemistry " used herein measurement is not related to the expansion of nucleic acid Increase, determine the analyte water in solution to the imaging of cell or based on antibody/conjugate of label is used in the microscopy stage It puts down and the determination to analyte level in solution.In some embodiments, it is executed in single vessel with all reagents general Logical chemical assay --- in order to be reacted, all necessary reagents are added to reaction vessels, and in the continuous mode phase Between, material is removed not from reaction or reaction vessels (such as without washing step；It is " mix and read " reaction).Commonly Chemical assay is also possible that for example, colorimetric estimation, enzymatic determination, spectroscopic assay, turbidimetric assay, agglutination determination, condensation measurement And/or other kinds of measurement.It can be by measuring the absorbance (example by measurement reaction to the light of one or more selected wavelength Such as with spectrophotometer measurement) it is measured to analyze many general chemistry.In some embodiments, measurement reaction can be passed through Turbidity (such as with spectrophotometer measurement) analyzes general chemistry measurement.In some embodiments, it can be reacted by measurement The chemiluminescence (such as being measured with PMT, photodiode or other optical sensors) of middle generation is surveyed to analyze general chemistry It is fixed.In some embodiments, can based in identical or related assays to other one or more analytes and determination Experiment value executes general chemistry measurement by calculating.In some embodiments, the fluorescence (example of measurement reaction can be passed through Such as, with detection unit, it includes or be connected to the light sources of i) one or more specific wavelengths (" excitation wavelength ")；And ii) Sensor is configured for detecting emitted light under one or more specific wavelengths (" excitation wavelength ")) it is general to analyze Logical chemical assay.It in some embodiments, can be by the agglutination in measurement reaction (such as by using spectrophotometer measurement The turbidity of reaction or the image by obtaining reaction with optical sensor) it is measured to analyze general chemistry.In some embodiment party Formula, can be by being imaged (such as being imaged with CCD or CMOS optical sensor) to reaction at one or more time points Image analysis is carried out, later to analyze general chemistry measurement.Optionally, analysis can be related to prothrombin time, activated partial Factor I time (APTT), any one can be measured by such as, but not limited to the methods of turbidimetry.One In a little embodiments, can by the viscosity of measurement reaction (such as with spectrophotometer, wherein the increase of reaction viscosity change it is anti- The optical property answered) it is measured to analyze general chemistry.In some embodiments, can by two kinds of non-antibody reagents of measurement it Between compound form (such as metal ion and chromophore；Spectrophotometer or the colorimetric method by using another device can be used To measure such reaction) it is measured to analyze general chemistry.It in some embodiments, can be by for measuring cellular antigens Non- ELISA or based on cell count method (such as blood group hemagglutination measure, this can for example, by reaction Turbidity measure) analyze general chemistry measurement.It in some embodiments, can be by means of electrochemical sensor (such as needle To the electrochemical sensor of carbon dioxide or oxygen) it is measured to analyze general chemistry.It also can be used addition method general to analyze Logical chemical assay.

In some embodiments, spectrophotometer can be used to measure general chemistry measurement.In some embodiments In, can last (" terminal " measurement) of measurement or at two or more times during continuous mode (" time into Journey " or " dynamics " measurement) measurement general chemistry measurement.

In some embodiments, the humoral sample or part thereof transported according to system provided herein or method can It is used in cell counting measuring.Cell counting measuring is commonly used in optics, electricity or the spy for acoustically measuring individual cells Sign.For present disclosure, " cell " may include acellular sample usually similar with individual cells size, including but It is not limited to vesica (such as liposome), cell microcommunity, virion, bacterium, protozoan, crystallization, passes through lipid and/or egg The entity and the substance in conjunction with little particle such as pearl or microballoon that the polymerization of white matter is formed.This category feature includes but is not limited to Size；Shape；Granularity；Light scattering diagram sample (or optical indicatrix)；Whether cell membrane is complete；Cell interior content it is dense Degree, form and spatial and temporal distributions, including but not limited to protein content, protein modification, nucleic acid content, nucleic acid modification, organelle Content, nuclear structure, core content, cell interior structure, internal compartment content (including pH), ion concentration and other small molecule examples Such as the presence of steroids or drug；With cell surface (both cell membrane and cell wall) marker, including protein, lipid, carbon Hydrate, and its modification.By using dyestuff appropriate, coloring agent or other mark molecules, either in a pure form, with Other molecule coupling labeleds are still fixed on or are incorporated on nano particle or micron particles, determine specific egg using cell count Presence, amount and/or the modification of white matter, nucleic acid, lipid, carbohydrate or other molecules.Cell count analysis can be for example, by Flow cytometry or microscopy carry out.Flow cytometry successively carries individual cells usually using the liquid medium of flowing To optics, electricity or sound wave detector.Microscopy detects fixed cell usually using optics or acoustic means, usually logical The image of overwriting at least width amplification.In embodiments, cell counting measuring can be related to obtain one or more in sample The image of a cell.In embodiments, the cell in sample can allowed to settle with desired configuration for imaging Microscopic slide or cuvette on or in sample is provided.It can be thin with for example being obtained based on the camera of CCD or CMOS The image of born of the same parents.

It in some embodiments, can be based on how detecting the result of detection and being carried out to laboratory testing type Classification.Different types of laboratory detection result detection can be for example including the detection that i) shines；Ii) fluorescence detection；Iii) absorbance Detection；Iv) scattering measuring；And it v) is imaged.What each of these detection methods were submitted at such as on 2 18th, 2013 It is described in U.S. Patent Application Serial Number 13/769,820, document full text is hereby incorporated into for all purposes.In short, It detection can shine from the detection for generating measurable optical signal.Such reaction for example can be chemiluminescence reaction.For Detection luminescence-producing reaction as a result, can be used the photodetectors such as PMT or photodiode to detect and carry out self-contained hair The light of the determination unit of light reaction.Can fluorescence for example be detected with including the Optical devices of light source and photodetector.Light source can Issue the light of one or more specific wavelengths.Determination unit comprising detecting material can be located in the path of light source, so that institute The light for stating one or more specific wavelengths reaches the content of determination unit (one or more " excitation wavelengths ").Determination unit It may include interested molecule, which at least absorbs in some cases under one or more specific wavelengths from light source Light, and then discharge different wave length light.Photodetector can be configured for detection and be discharged by interested molecule Light (one or more " launch wavelength ").Light source and/or photodetector can include band after light source or before photodetector Bandpass filter, to limit one or more wavelength from light source or the light for reaching photodetector.Light source for example can be lamp Bubble, laser or LED, and photodetector for example can be PMT or photodiode.It can for example be examined with including light source and light The Optical devices of device are surveyed to detect absorbance.Light source and photodetector can be each other in a straight line, and are configured so that and include The determination unit for detecting material can be between light source and photodetector, so that so that some light is may pass through detection material reaches light Detector and some light can be absorbed.It is based on detection as a result, different amounts of light can be detected material is absorbed.Similarly, It can determine the light transmission across detection material.Measurement is determined for absorption/transmission, by one or more of the light that light source issues A wavelength can be identical as the one or more wavelength of light detected by photodetector.Light source for example can be light bulb, laser Device or LED, and photodetector for example can be PMT or photodiode.It can be for example with the light including light source and photodetector It learns device and carrys out detection light scattering.Light source and photodetector can at an angle relative to each other, and be configured so that comprising inspection Measure and monitor the growth of standing timber material determination unit can simultaneously with light source and photodetector in line, to make the reachable measurement of the light from light source Detection material in unit and measured unit is scattered, to reach photodetector.It is based on detection as a result, different amounts of light Material can be detected to be scattered.Light source for example can be light bulb, laser or LED, and photodetector for example can be PMT or Photodiode.The image for detecting material can be for example by the detection including imaging sensor (for example, CCD or cmos sensor) Device obtains.In general, imaging sensor will be included in camera.Automation or manual image analysis can for example be passed through Carry out the image of analysis detection material, to determine testing result.Humoral sample provided in this article can also be used in by based on non- Optical detection method (for example, measurement conductivity, radioactivity or temperature) carrys out the laboratory testing of testing result.

It in embodiments, can be by the institute of humoral sample in order to execute measurement/detection with a part of humoral sample Part is stated to be transferred in determination unit at least one step in measuring/detecting.Determination unit can have various shape because Son, such as pipettor tip, pipe or microscopic slide.The step of measurement that can occur in determination unit, for example can wrap The analyte included in sample combines with the conjugate (for example, antibody) for the analyte, expands sample in nucleic acid amplification reaction Target nucleic acid in product, the sample condensation of the addition based on one or more reagents into sample or use are used for optical analysis Configuration sample (for example, on cell settlement to the surface of microscopic slide, to promote to obtain one of the cell Or multiple images).Term as used herein " measurement " and " detection " are used interchangeably, unless the context clearly determines otherwise.

Embodiment

Following embodiment is provided merely for purpose is illustrated, and is not intended to be limiting in any manner in the disclosure Hold.

Embodiment 1

Whole blood sample is obtained from subject.The whole blood sample is centrifuged in vessel, so that whole blood to be divided into The cell and plasma supernatant of precipitating.Vessel after centrifugation are moved to the glove box of argon gas purging.By blood plasma after centrifugation Vessel be sucked out and it is then whole assign in 5 as herein provided individual sample vessel, wherein sample vessel respectively have Internal capacity no more than 100 microlitres, wherein by being assigned in each sample vessel no more than 95 microlitres of blood plasma is whole, and its In each sample vessel there is same size and receive the blood plasma of same volume.Vessel respectively have removable butyl rubber Cap.5 sample vessel are associated with label " 0 hour ", " 1 hour ", " 2 hours ", " 8 hours " and " 24 hours ".? When being associated with the corresponding period of each sample vessel, the measurement for bicarbonate is carried out to the sample in each vessel.With Under the result of measurement is provided in table 1.

Table 1

As shown in table 1, in sample vessel provided in this article, the bicarbonate in sample is at least 24 hours It is stable.

Embodiment 2

Whole blood sample is obtained from subject.EDTA and the whole blood sample are mixed.By 80 microlitres of blood containing EDTA It is whole to assign in each of 10 sample vessel as herein provided, wherein each sample vessel are with micro- no more than 100 The internal capacity risen, and there is same size.Sample vessel are associated with following label to be used to analyze: in real time: the 1st day, 2nd day, the 3rd day, the 4th day, the 5th day and the 7th day；It is centrifugated in advance: the 1st day, the 2nd day, the 4th day and the 7th day.Each " warp The vessel of pre- centrifuge separation " by sample it is whole assign in the vessel when be centrifugated, to generate the thin of blood plasma and precipitating Born of the same parents.Each " real-time " vessel are centrifugated in corresponding day, to generate the cell of blood plasma and precipitating.By whole point of sample After into each sample vessel, covered.In the corresponding day for each vessel, blood plasma is removed simultaneously from vessel It is measured for blood urea nitrogen (BUN).BUN measurement result is shown in the chart of Figure 48.As identified in the chart, exist In sample vessel provided in this article, the BUN in sample keeps stablizing at least 7 days, all protects in whole blood and plasma sample It is fixed to keep steady.

Publication that is described herein or illustrating be intended merely to their disclosures before the filing date of the present application and It provides.Any item herein should be construed as recognizing that the present invention haves no right by formerly invention and in advance in such Publication.In addition, provided publication date may be different from practical publication date, practical publication date may need independence Confirmation.All publications being mentioned herein are incorporated by reference into this, so as to the publication phase of disclosure and description and reference Associated structure and/or method.Following applications were incorporated by this for all purposes by reference: January 21 in 2011 (" the SYSTEMS AND METHODS FOR SAMPLE USE of U.S. Provisional Patent Application No. 61/435,250 that day submits MAXIMIZATION ") and U.S. Patent Publication No. 2009/0088336 (" MODULAR POINT-OF-CARE DEVICES, SYSTEMS,AND USES THEREOF").Following applications are incorporated by also by reference in this for all purposes: the U.S. Patent disclosure 2005/0100937, United States Patent (USP) 8,380,541；In on 2 18th, 2013 U.S. Patent Application Serials submitted Number 61/766,113；In 2 months 2013 U.S. Patent Application Serial Numbers 13/769,798 submitted for 18th；At 2 months 2013 The U.S. Patent Application Serial Number 13/769,779 submitted for 18th；In on 2 18th, 2013 U.S. Patent Application Serials submitted Number 13/769,820；In the U.S. Patent Application Serial Number 13/244,947 that September in 2011 is submitted on the 26th；In in September, 2012 The PCT/US2012/57155 submitted on the 25th；In the Application U.S. Serial No 13/244,946 that September in 2011 is submitted on the 26th；? The U.S. Patent application 13/244,949 that September in 2011 is submitted on the 26th；And in the U. S. application submitted on the 26th of September in 2011 Sequence number 61/673,245, the disclosure of above-mentioned patents and patent applications are all incorporated by by reference in this hereby.

Embodiment

In an embodiment described herein, a kind of humoral sample for collecting from subject is provided Device, comprising: at least two sample collection paths, be configured for by the humoral sample from subject's phase The single end of the described device of contact is sucked into described device, so that fluid sample to be separated into the sample of two separation； Second part comprising for receiving the multiple sample devices for the humoral sample being collected in the sample collection path Ware, the sample vessel can be operatively engaged to be in fluid communication with the sample collection path, then when establishing fluid When connection, the vessel provide power so that the major part of described two isolated samples is moved to the device from the access In ware.

In another embodiment described herein, provide a kind of for collecting the device of humoral sample, comprising: First part comprising lead at least one fluid collection position of at least two sample collection paths, the sample collection is logical Road is configured for sucking fluid sample wherein via the first type power；Second part comprising be collected for receiving Multiple sample vessel of the humoral sample in the sample collection path, the sample vessel can operationally connect It closes to be in fluid communication with the sample collection path, then when establishing fluid communication, the vessel are provided different from described Second power of the first power is the major part of the humoral sample to be moved in the vessel from the access；Wherein institute Stating at least one of sample collection path includes pad indicator, which is used to indicate when reach minimum and fill out Water-filling it is flat and can engage at least one of the sample vessel with at least one of sample collection path stream Body connection.

In another embodiment described herein, provide a kind of for collecting the device of humoral sample, comprising: First part comprising at least two sample collection channels, the sample collection channels are configured for via the first type power Fluid sample is drawn into the sample collection channels, wherein one of described sample collection channels have designed for The coated inside that fluid sample mixes, and in the sample collection channels another have be chemically different from it is described in Another coated inside of portion's coating；Second part comprising for receive be collected in the sample collection channels described in Multiple sample vessel of humoral sample, the sample vessel can be operatively engaged to connect with the collection channel fluid Logical, then when establishing fluid communication, the vessel, which provide, is different from the second power of first power with by the body The major part of liquid sample is moved in the vessel from the channel；Wherein vessel are arranged so that fluid between the vessel The mixing of sample will not occur.

In another embodiment described herein, provide a kind of for collecting the device of humoral sample, comprising: First part comprising multiple sample collection channels, wherein at least two in the channel are configured for via the first type Fluid sample is drawn into each of described at least two sample collection channels by power simultaneously；Second part, packet Multiple sample vessel for receiving the humoral sample being collected in the sample collection channels are included, wherein the sample Product vessel have the first situation and the second situation, and the sample vessel described in first situation are not logical with the sample collection Road be in fluid communication, and the sample vessel described in second situation can be operatively engaged with the collection channel stream Body connection, then when establishing fluid communication, the vessel, which provide, is different from the second power of first power with by body Liquid sample is moved in the vessel from the channel.

In another embodiment described herein, a kind of sample collection device is provided, comprising: (a) collects logical Road comprising the first opening and the second opening, and be configured for via capillarity from first opening described in Second opening sucking humoral sample；And (b) for receiving the sample vessel of the humoral sample, the vessel can with it is described Collection channel engages, and with wherein with the inside of vacuum, and has and is configured for the cap of receiving channel；Wherein Second opening is limited by a part of the collection channel, and the part is configured for penetrating the sample vessel The cap, and provide the fluid flowing path between the collection channel and the sample vessel, and the sample vessel Ten times of the internal capacity with the internal capacity no more than the collection channel.

In another embodiment described herein, a kind of sample collection device is provided, comprising: (a) collects logical Road comprising the first opening and the second opening, and be configured for via capillarity from first opening described in Second opening sucking humoral sample；(b) for receiving the sample vessel of the humoral sample, the vessel can be with the collection Channel engages, and with wherein with the inside of vacuum, and has and is configured for the cap of receiving channel；And it (c) fits Orchestration channel, the fluid flowing path being configured to provide between the collection channel and the sample vessel have first Opening and the second opening, first opening are configured for contacting second opening of the collection channel, and described the Two openings are configured for penetrating the cap of the sample vessel.

In another embodiment described herein, a kind of sample collection device is provided, comprising: (a) main body, Comprising collection channel, the collection channel includes the first opening and the second opening, and be configured for via capillarity from First opening sucks body fluid towards second opening；(b) pedestal, it includes the samples for receiving the humoral sample Product vessel, the sample vessel can be engaged with the collection channel, with wherein with the inside of vacuum, and having It is configured for the cap of receiving channel；And (c) bracket, wherein the main body and the pedestal are connected to the phase of the bracket Opposite end, and be configured to be moved relative to each other so that sample collection device be configured to extended state and Compressive state, wherein at least part of the pedestal is in the extended state of described device than in the compressive state In closer to the main body, the second opening of the collection channel is configured for penetrating the cap of the sample vessel, In the extended state of described device, second opening of the collection channel is not described interior with the sample vessel Portion is in contact, and in the compressive state of described device, and second opening of the collection channel is across the device The cap of ware extends in the inside of the sample vessel, to provide the collection channel and the sample device Fluid communication between ware.

In another embodiment described herein, a kind of sample collection device is provided, comprising: (a) main body, Comprising collection channel, the collection channel includes the first opening and the second opening, and be configured for via capillarity from First opening sucks body fluid towards second opening；(b) pedestal, it includes the sample devices for receiving humoral sample Ware, the sample vessel can be engaged with the collection channel, with wherein with vacuum inside, and have matched Set the cap for receiving channel；(c) bracket, and (d) adaptor channel, with the first opening and the second opening, described One opening is configured for contacting second opening of the collection channel, and second opening is configured for wearing The cap of the saturating sample vessel, wherein the main body and the pedestal are connected to the opposite end of the bracket, and by It is configured to be moved relative to each other, so that sample collection device is configured to extended state and compressive state, wherein At least part of the pedestal in the extended state of described device than in the compressive state closer to described Main body, in the extended state of described device, the adaptor channel not with the collection channel and the sample device One of described inside of ware or whole the two are in contact, and in the compressive state of described device, the adaptation First opening in device channel is in contact with second opening of the collection channel, and the adaptor channel Second opening extends in the inside of the sample vessel across the cap of the vessel, thus described in providing Fluid communication between collection channel and the sample vessel.

In another embodiment described herein, a kind of fluid sample for collecting from subject is provided Device, comprising: (a) main body, it includes collection channel, the collection channel includes the first opening and the second opening, and by It is configured to suck body fluid from first opening towards second opening via capillarity；(b) pedestal, can be with institute It states main body to engage, wherein the base supports sample vessel, the vessel can be engaged with the collection channel, be had Wherein with the inside of vacuum, and there is the cap for being configured for receiving channel；Wherein described the second of the collection channel Opening is configured for penetrating the cap of the sample vessel, and provide the collection channel and the sample vessel it Between fluid flowing path.

In another embodiment described herein, a kind of fluid sample for collecting from subject is provided Device, comprising: (a) main body, it includes collection channel, the collection channel includes the first opening and the second opening, and by It is configured to suck body fluid from first opening towards second opening via capillarity；(b) pedestal, can be with institute It states main body to engage, wherein the base supports sample vessel, the sample vessel can be engaged with the collection channel, tool Have in the inside wherein with vacuum, and there is the cap for being configured for receiving channel；And (c) adaptor channel, tool There are the first opening and the second opening, first opening is configured for contacting second opening of the collection channel, And second opening is configured for penetrating the cap of the sample vessel.

It should be appreciated that one or more of following characteristics may be adapted to together with any embodiment described herein It uses.For lifting non-limiting example, the main body may include two collection channels.Optionally, one or more collections The internal coat in channel has anti-coagulants.Optionally, the main body includes the first collection channel and the second collection channel, and institute The internal coat for stating the first collection channel has the anti-coagulants different from the inside of second collection channel.Optionally, described One anti-coagulants is ethylenediamine tetra-acetic acid (EDTA), and second anti-coagulants is different from EDTA.Optionally, described first is anticoagulant Agent is citrate, and second anti-coagulants is different from citrate.Optionally, first anti-coagulants is heparin, and Second anti-coagulants is different from heparin.Optionally, a kind of anti-coagulants is heparin, and second anti-coagulants is EDTA.It is optional Ground, a kind of anti-coagulants are heparin, and second anti-coagulants is citrate.Optionally, a kind of anti-coagulants is citrate, And second anti-coagulants is EDTA.Optionally, the main body is formed by light transmitting material.Optionally, described device include with The same number of sample vessel of collection channel.Optionally, described device includes logical with the same number of adapter of collection channel Road.Optionally, the pedestal includes optical indicator, and it is described whether the optical indicator offer reaches the sample Sample vessel in pedestal visually indicate.Optionally, the pedestal is window, and user is allowed to check the pedestal In the vessel.Optionally, the bracket includes spring, and spring applied force is so that when described device is in it certainly When right state, described device is in the extended state.Optionally, the second of the collection channel or the adaptor channel Opening is covered by sleeve, wherein the sleeve does not prevent body fluid from being open from described first towards described the via capillarity The movement of two openings.Optionally, the sleeve includes discharge orifice.Optionally, each collection channel can be accommodated no more than 500uL Volume.Optionally, each collection channel can accommodate the volume no more than 200uL.Optionally, each collection channel can accommodate Volume no more than 100uL.Optionally, each collection channel can accommodate the volume no more than 70uL.Optionally, each collection Channel can accommodate the volume no more than 500uL.Optionally, each collection channel can accommodate the volume no more than 30uL.It is optional The inner circumferential on ground, the cross section of each collection channel is failed to grow up in 16mm.Optionally, the inner circumferential of the cross section of each collection channel It fails to grow up in 8mm.Optionally, the inner circumferential of the cross section of each collection channel is failed to grow up in 4mm.Optionally, the interior perimeter is Circumference.Optionally, described device includes the first collection channel and the second collection channel, and the opening phase of the first passage Adjacent to the opening of the second channel, and the opening is configured for simultaneously from liquid blood sampling of singly bleeding.Optionally, described The opening of first passage and the opening of the second channel have between the center to center less than or equal to about 5mm Away from.Optionally, each sample vessel have twentyfold no more than the internal capacity of its pieceable collection channel Internal capacity.Optionally, each sample vessel have ten times of the internal capacity no more than its pieceable collection channel Internal capacity.Optionally, each sample vessel have five of the internal capacity no more than its pieceable collection channel Internal capacity again.Optionally, each sample vessel have the internal capacity no more than its pieceable collection channel Twice of internal capacity.Optionally, the foundation of the fluid communication between the collection channel and the sample vessel leads to institute State at least 90% transfer into the sample vessel of the humoral sample in collection channel.

It should be appreciated that one or more of following characteristics may be adapted to together with any embodiment described herein It uses.Optionally, the foundation of the fluid communication between the collection channel and the sample vessel causes in the collection channel The humoral sample at least 95% transfer into the sample vessel.Optionally, the collection channel and the sample The foundation of fluid communication between product vessel causes at least 98% of the humoral sample in the collection channel to the sample Transfer in product vessel.Optionally, the foundation of the fluid communication between the collection channel and the sample vessel causes described Transfer of the humoral sample into the sample vessel, and cause the humoral sample for being no more than 10uL to be retained in described collect and lead to In road.Optionally, the foundation of the fluid communication between the collection channel and the sample vessel cause the humoral sample to Transfer in the sample vessel, and the humoral sample no more than 5uL is caused to be retained in the collection channel.Optionally, The engagement of the collection channel and the sample vessel leads to transfer of the humoral sample into the sample vessel, and The humoral sample no more than 2uL is caused to be retained in the collection channel.

It in another embodiment described herein, provides a method, comprising: make the one of sample collection device End in contact humoral sample, by being inhaled via the first type power at least two collection channels of the sample collection device Enter the sample, the sample is divided at least two parts；It is in described in the sample fluid for having been acknowledged desired amount After at least one of collection channel, establishes and is in fluid communication between the sample collection channels and the sample vessel, Then the vessel provide the second power for being different from first power, and each section of humoral sample is moved to it In corresponding vessel.

In another embodiment described herein, provide a method, comprising: filled by using sample collection It sets and minimal amount of sample is metered at least two channels, the sample collection device has in sample collection channels At least two, at least two sample collection channels are configured for simultaneously sucking fluid sample via the first type power To in each of at least two sample collection channels；The receipts are in the sample fluid for having been acknowledged desired amount After collecting in channel, establishes and be in fluid communication between the sample collection channels and the sample vessel, then the vessel mention For being different from that humoral sample is moved to institute from the channel to the second power for collecting first power of sample It states in vessel.

In another embodiment described herein, a kind of method for collecting humoral sample is provided, comprising: (a) makes Humoral sample is in contact with the device for including collection channel, and the collection channel includes the first opening and the second opening, and by It is configured to via capillarity from first opening towards the second opening sucking body fluid, so that the body fluid sample Product fill the collection channel across second opening from first opening；(b) in the collection channel and sample vessel Inside between establish fluid flowing path, the sample vessel have ten times of the internal capacity no more than the collection channel Internal capacity, and before the foundation of the fluid flowing path between the collection channel and the inside of the sample vessel With vacuum, so that the foundation of the fluid flowing path between the collection channel and the inside of the sample vessel is in institute Second opening for stating collection channel generates negative pressure, and fluid sample is transferred to the sample from the collection channel The inside of product vessel.

In another embodiment described herein, a kind of method for collecting humoral sample is provided, comprising: (a) makes Humoral sample is in contact with any collection device as described herein, so that the humoral sample is from one in described device First opening of at least one of a or multiple collection channels fills the collection channel across the second opening；And (b) Establish fluid flowing path between the collection channel and the inside of the sample vessel so that establish the collection channel with Fluid flowing path between the inside of the sample vessel generates negative pressure in second opening of the collection channel, And fluid sample is transferred to the inside of the sample vessel from the collection channel.

It should be appreciated that one or more of following characteristics may be adapted to together with any embodiment described herein It uses.Optionally, the internal fluid communication for not making the collection channel Yu the sample vessel, until body fluid reaches institute State second opening of collection channel.Optionally, described device includes two collection channels, and leads to described collect The internal fluid communication in road and the sample vessel is opened until body fluid reaches described the second of all two collection channels Mouthful.Optionally, second opening of the collection channel in described device is configured for penetrating the sample vessel The cap, and wherein by providing the opposite shifting between second opening of the collection channel and the sample vessel It is dynamic so that second opening of the collection channel penetrates the cap of the sample vessel, come establish it is described collect it is logical Fluid flowing path between second opening in road and the sample vessel.Optionally, described device includes being directed to described device In each collection channel adaptor channel, the adaptor channel have the first opening and the second opening, described first Opening is configured for contacting second opening of the collection channel, and second opening is configured for penetrating The cap of the sample vessel, and it is wherein described suitable by second opening of offer (a) described collection channel, (b) The relative movement between two or more items in orchestration channel and (c) the sample vessel is so that the adapter is logical Second opening in road penetrates the caps of the sample vessel, come establish the collection channel and the sample vessel it Between fluid flowing path.

In another embodiment described herein, a kind of humoral sample for collecting from subject is provided Method, comprising: (a) makes to include that the device of first passage and second channel is in fluid communication with the body fluid from the subject, Each channel has feed opening, and the feed opening is configured for being in fluid communication with the body fluid, and each channel has Outlet opening positioned at the feed opening downstream in each channel, and each channel is configured for via capillarity Body fluid is sucked from the feed opening towards the outlet opening；(b) by the first passage and the second channel The outlet opening of each, make the first passage and the second channel correspondingly with the first vessel and the second vessel It is in fluid communication；And (c) by means of the following terms, by the body in each of the first passage and second channel Liquid is guided to each of first vessel and the second vessel: (i) is in first vessel or second vessel Relative to the negative pressure of environmental stress, wherein the negative pressure is enough to generate the body fluid across the first passage or described second Flowing of the channel into its corresponding vessel, or (ii) the first passage or the second channel upstream relative to The positive pressure of environmental stress, wherein the positive pressure is enough to generate the whole blood sample across the first passage or described second logical Flowing of the road into its corresponding vessel.

In another embodiment described herein, a kind of method of perparation of specimen collection device is provided, comprising: The a part with the sample collection device at least two channels is formed, the channel is configured for via the first type power Fluid sample is drawn into each of described at least two sample collection channels simultaneously；Sample vessel are formed, then The vessel are configured for being coupled to the sample collection device, to provide different from described first to collect sample Second power of power, so that humoral sample is moved in the vessel from the channel.

In another embodiment described herein, computer executable instructions are provided, for executing a kind of side Method, which comprises form a part with the sample collection device at least two channels, the channel is configured to use It is drawn into each of described at least two sample collection channels in via the first type power while by fluid sample.

In another embodiment described herein, computer executable instructions are provided, for executing a kind of side Method, which comprises sample vessel are formed, then the vessel are configured for being coupled to the sample collection device, with The second power being different to collect first power of sample is provided, so that humoral sample is mobile from the channel To in the vessel.

It is a kind of for collecting the device of the humoral sample from subject in another embodiment described herein, Described device include: sucked into described device for the single end from the described device being in contact with the subject described in Fluid sample so that is divided into the device of the sample of two separation by humoral sample；Described in being moved to multiple sample vessel transfers The device of fluid sample, wherein the vessel provide power with by the most of from the access of described two isolated samples It is moved in the vessel.

Although being the complete description to preferred embodiment as described herein above, it is likely that being replaced using various Generation, modification and equivalent.Therefore, it not should refer to above description and determine the scope of the present invention, but should refer to appended power Sharp claim comes together to determine the scope of the present invention together with the full scope of its equivalent.No matter preferably whether any spy Sign can with no matter preferably whether any other feature be combined.The appended claims are not necessarily to be construed as including device Add the restriction of function, unless such restriction is defined using phrase " device being used for ... " in a given claim It illustrates.It should be appreciated that as used in description herein and subsequent claims full text, "one", "an" and The meaning of "the" etc. includes plural reference, unless the context clearly determines otherwise.In addition, such as description herein and then Claims full text used in, " among " meaning include " among " and " on ", unless the context otherwise clearly Regulation.Finally, the meaning of "and" and "or" is wrapped simultaneously as used in description herein and subsequent claims full text It includes combination and separation, and uses with can be interchanged, unless the context clearly determines otherwise.Therefore, term is being used In the context of "and" and "or", the use of such conjunction is not excluded for the meaning of "and/or", bright unless the context otherwise Really regulation.Following U.S. Patent application is incorporated by reference into this for all purposes: being submitted on December 5th, 2012 61/733,886, September in 2013 submit within 7th 61/875,030 and submitted within 8th in September in 2013 61/875,107.This Document includes material protected by copyright.Copyright owner (applicant of this paper) does not oppose in patent document and disclosure The copy of appearance replicates, because they come across in U.S.Patent & Trademark Office's patent document or record, but in addition to this retains any All copyrights.Following notice should be applicable in: 2013 Theranos Inc. of copyright.

Claims

1. a kind of for collecting the device of the humoral sample from subject, described device includes:

At least two sample collection paths are configured for the humoral sample described in be in contact with the subject The single end of device is sucked into described device, so that fluid sample to be separated into the sample of two separation；

Second part comprising for receiving the multiple samples for the humoral sample being collected in the sample collection path Vessel, the sample vessel can be operatively engaged with the sample collection path be in fluid communication, then when establish stream When body is connected to, the vessel provide power so that the major part of described two isolated samples is moved to the device from the access In ware.

2. a kind of for collecting the device of humoral sample, described device includes:

First part comprising lead at least one fluid collection position of at least two sample collection paths, the sample is received Collection access is configured for sucking fluid sample wherein via the first type power；

Second part comprising for receiving the multiple samples for the humoral sample being collected in the sample collection path Vessel, the sample vessel can be operatively engaged with the sample collection path be in fluid communication, then when establish stream When body is connected to, the vessel, which provide, is different from the second power of first power with by the most of from institute of the humoral sample Access is stated to be moved in the vessel；

Wherein at least one of described sample collection path includes pad indicator, which is used to indicate when reach To minimum fill level and can engage at least one of the sample vessel with in the sample collection path extremely A few fluid communication.

3. a kind of for collecting the device of humoral sample, described device includes:

First part comprising at least two sample collection channels, the sample collection channels are configured for via the first type Fluid sample is drawn into the sample collection channels by power, is designed for wherein one of described sample collection channels have The coated inside mixed with fluid sample, and in the sample collection channels another have be chemically different from it is described in Another coated inside of portion's coating；

Second part comprising for receiving the multiple samples for the humoral sample being collected in the sample collection channels Vessel, the sample vessel can be operatively engaged with the collection channel be in fluid communication, then when establish fluid connect When logical, the vessel provide the second power for being different from first power to lead to the most of of the humoral sample from described Road is moved in the vessel；

Wherein vessel are arranged so that the mixing of fluid sample will not occur between the vessel.

4. a kind of for collecting the device of humoral sample, described device includes:

First part comprising multiple sample collection channels, wherein at least two in the channel are configured for via Fluid sample is drawn into each of described at least two sample collection channels by one type power simultaneously；

Second part comprising for receiving the multiple samples for the humoral sample being collected in the sample collection channels Vessel, wherein the sample device ware have the first situation and the second situation, the sample vessel described in first situation not with The sample collection channels are in fluid communication, and the sample vessel described in second situation can be operatively engaged with institute Collection channel fluid communication is stated, then when establishing fluid communication, the vessel, which provide, is different from the of first power Two power are humoral sample to be moved in the vessel from the channel.

5. a kind of sample collection device, comprising:

(a) collection channel comprising the first opening and the second opening, and be configured for via capillarity from described first Opening sucks humoral sample towards second opening；And

(b) for receiving the sample vessel of the humoral sample, the vessel can be engaged with the collection channel, be had at it In the inside with vacuum, and have and be configured for the cap of receiving channel；

Wherein second opening is limited by a part of the collection channel, and the part is configured for penetrating the sample The cap of product vessel, and the fluid flowing path between the collection channel and the sample vessel is provided, and

The sample vessel have ten times of internal capacity of the internal capacity no more than the collection channel.

6. a kind of sample collection device, comprising:

(a) collection channel comprising the first opening and the second opening, and be configured for via capillarity from described first Opening sucks humoral sample towards second opening；

(b) for receiving the sample vessel of the humoral sample, the vessel can be engaged with the collection channel, be had at it In the inside with vacuum, and have and be configured for the cap of receiving channel；And

(c) adaptor channel, the fluid flowing path being configured to provide between the collection channel and the sample vessel, With the first opening and the second opening, first opening is configured for contacting second opening of the collection channel, Second opening is configured for penetrating the cap of the sample vessel.

7. a kind of sample collection device, comprising:

(a) main body, it includes collection channel, the collection channel includes the first opening and the second opening, and is configured for Body fluid is sucked from first opening towards second opening via capillarity；

(b) pedestal, it includes the sample vessel for receiving the humoral sample, the sample vessel can be with the collection channel It engages, with wherein with the inside of vacuum, and has and be configured for the cap of receiving channel；And

(c) bracket,

Wherein,

The main body and the pedestal are connected to the opposite end of the bracket, and are configured to be moved relative to each other, with So that sample collection device is configured to extended state and compressive state, wherein at least part of the pedestal is described In the extended state of device than in the compressive state closer to the main body,

Second opening of the collection channel is configured for penetrating the cap of the sample vessel,

In the extended state of described device, the second opening not institute with the sample vessel of the collection channel Interior thereof touching is stated, and

In the compressive state of described device, second opening of the collection channel is across described in the vessel Cap extends in the inside of the sample vessel, to provide the stream between the collection channel and the sample vessel Body connection.

8. a kind of sample collection device, comprising:

(b) pedestal, it includes the sample vessel for receiving humoral sample, the sample vessel can connect with the collection channel It closes, has wherein with the inside of vacuum, and with being configured for the cap of receiving channel；

(c) bracket, and

(d) adaptor channel, with the first opening and the second opening, first opening is configured for contacting the collection Second opening in channel, and second opening is configured for penetrating the cap of the sample vessel,

Wherein, the main body and the pedestal are connected to the opposite end of the bracket, and are configured to move relative to each other It is dynamic, so that sample collection device is configured to extended state and compressive state, wherein at least part of the pedestal Than closer to the main body, being stretched described in the described device in the compressive state in the extended state of described device In exhibition state, the adaptor channel is not with one of the inside of the collection channel and the sample vessel or all The two is in contact, and in the compressive state of described device, the adaptor channel it is described first opening with it is described Second opening of collection channel is in contact, and second opening of the adaptor channel is across the institute of the vessel Cap is stated, is extended in the inside of the sample vessel, to provide between the collection channel and the sample vessel It is in fluid communication.

9. a kind of for collecting the device of the fluid sample from subject, comprising:

(b) pedestal can be engaged with the main body, wherein the base supports sample vessel, the vessel can be with the receipts Collection channel engages, and has wherein with the inside of vacuum, and with being configured for the cap of receiving channel；

Wherein

Second opening of the collection channel is configured for penetrating the cap of the sample vessel, and described in offer Fluid flowing path between collection channel and the sample vessel.

10. a kind of for collecting the device of the fluid sample from subject, comprising:

(b) pedestal can be engaged with the main body, wherein the base supports sample vessel, the sample vessel can be with institute It states collection channel to engage, with wherein with the inside of vacuum, and has and be configured for the cap of receiving channel；And

(c) adaptor channel, with the first opening and the second opening, first opening is configured for contacting the collection Second opening in channel, and second opening is configured for penetrating the cap of the sample vessel.

11. device according to any one of the preceding claims, wherein the main body includes two collection channels.

12. the internal coat of device according to any one of the preceding claims, wherein one or more collection channels has Anti-coagulants.

13. device according to claim 10, wherein the main body includes the first collection channel and the second collection channel, and And the internal coat of first collection channel has the anti-coagulants different from the inside of second collection channel.

14. device according to claim 11, wherein first anti-coagulants is ethylenediamine tetra-acetic acid (EDTA), and it is described Second anti-coagulants is different from EDTA.

15. device according to claim 11, wherein first anti-coagulants is citrate, and second anti-coagulants Different from citrate.

16. device according to claim 11, wherein first anti-coagulants is heparin, and second anti-coagulants is different In heparin.

17. device according to any one of the preceding claims, wherein the main body is formed by light transmitting material.

18. device according to any one of the preceding claims, wherein described device includes identical as collection channel number Sample vessel.

19. the device according to any one of 4,6 or 8-14 of claim, wherein described device includes and collection channel number Identical adaptor channel.

20. device according to any one of the preceding claims, wherein the pedestal includes optical indicator, the optics Indicator provides visually indicating for the sample vessel whether reached in the pedestal for sample.

21. device according to claim 16 allows user to check in the pedestal wherein the pedestal is window The vessel.

22. the device according to any one of 5,6 or 9-17 of claim, wherein the bracket includes spring, and spring For applied force so that when described device is in its nature, described device is in the extended state.

23. device according to any one of the preceding claims, wherein the collection channel or the adaptor channel Second opening is covered by sleeve, wherein the sleeve does not prevent body fluid via capillarity from described in the first opening direction The movement of second opening.

24. device according to claim 19, wherein the sleeve includes discharge orifice.

25. device according to any one of the preceding claims, wherein each collection channel can be accommodated no more than 500uL's Volume.

26. device according to any one of the preceding claims, wherein each collection channel can be accommodated no more than 200uL's Volume.

27. device according to any one of the preceding claims, wherein each collection channel can be accommodated no more than 100uL's Volume.

28. device according to any one of the preceding claims, wherein the interior perimeter of the cross section of each collection channel is not Greater than 16mm.

29. device according to any one of the preceding claims, wherein the interior perimeter of the cross section of each collection channel is not Greater than 8mm.

30. device according to any one of the preceding claims, wherein the interior perimeter of the cross section of each collection channel is not Greater than 4mm.

31. device according to any one of the preceding claims, wherein inner circumferential length is circumference.

32. device according to any one of the preceding claims, wherein described device includes the first collection channel and second Collection channel, and the opening of the first passage is adjacent to the opening of the second channel, and the opening is configured to use In simultaneously from liquid blood sampling of singly bleeding.

33. device according to claim 28, wherein the institute of the opening of the first passage and the second channel Opening is stated with the center to center spacing less than or equal to about 5mm.

34. device according to any one of the preceding claims, wherein each sample vessel are with engageable no more than its The collection channel internal capacity twentyfold internal capacity.

35. device according to claim 30, wherein each sample vessel, which have, is not more than its pieceable described collection Ten times of internal capacity of the internal capacity in channel.

36. device according to claim 31, wherein each sample vessel, which have, is not more than its pieceable described collection Five times of internal capacity of the internal capacity in channel.

37. device according to claim 32, wherein each sample vessel, which have, is not more than its pieceable described collection Twice of internal capacity of the internal capacity in channel.

38. device according to any one of the preceding claims, wherein between the collection channel and the sample vessel The foundation of fluid communication cause at least 90% of the humoral sample in the collection channel into the sample vessel Transfer.

39. device according to claim 34, wherein the fluid communication between the collection channel and the sample vessel Foundation lead at least 95% transfer into the sample vessel of the humoral sample in the collection channel.

40. device according to claim 35, wherein the fluid communication between the collection channel and the sample vessel Foundation lead at least 98% transfer into the sample vessel of the humoral sample in the collection channel.

41. device according to any one of the preceding claims, wherein between the collection channel and the sample vessel The foundation of fluid communication lead to transfer of the humoral sample into the sample vessel, and lead to the body no more than 10uL Liquid sample is retained in the collection channel.

42. the device according to any one of claim 37, wherein between the collection channel and the sample vessel The foundation of fluid communication leads to transfer of the humoral sample into the sample vessel, and leads to the body fluid no more than 5uL Sample is retained in the collection channel.

43. the device according to any one of claim 39, wherein the engagement of the collection channel and the sample vessel Lead to transfer of the humoral sample into the sample vessel, and it is described to cause the humoral sample no more than 2uL to be retained in In collection channel.