Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L9/00—Supporting devices; Holding devices
  • B01L9/06—Test-tube stands; Test-tube holders
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
  • B01L3/5025—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures for parallel transport of multiple samples
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/54—Labware with identification means
  • B01L3/545—Labware with identification means for laboratory containers
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/18—Transport of container or devices
  • B01L2200/185—Long distance transport, e.g. mailing
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/02—Identification, exchange or storage of information
  • B01L2300/021—Identification, e.g. bar codes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/02—Identification, exchange or storage of information
  • B01L2300/021—Identification, e.g. bar codes
  • B01L2300/022—Transponder chips
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
  • B01L2300/041—Connecting closures to device or container
  • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
  • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/04—Moving fluids with specific forces or mechanical means
  • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
  • B01L2400/0409—Moving fluids with specific forces or mechanical means specific forces centrifugal forces

Definitions

• motive force to move a bodily fluid may include motive force derived from capillary action, from reduced pressure (e.g., vacuum or partial vacuum drawing fluid into a location having reduced pressure), from increased pressure (e.g., to force a fluid away from a location having increased pressure), from wicking material, or from other means.
• reduced pressure e.g., vacuum or partial vacuum drawing fluid into a location having reduced pressure
• increased pressure e.g., to force a fluid away from a location having increased pressure
• wicking material e.g., from wicking material, or from other means.
• the separator material may be a UV-curable material such as but not limited to thixotropic gel of sorbitol-based gelator in a diacrylate oligomer.
• the sample vessel may have the entire vessel or optionally, on that portion with the UV-curable material exposed to UV light for a period of time such as but not limited to 10 to 30 seconds to harden the material. Such hardening may involve cross-linking of material in the UV-curable material.
• the UV curable material may be used in conjunction with traditional separator gel material such that only one side (the solution side or the solid side) is in contact with the UV cured material.
• the UV cured material may be used with a third material such that the UV cured material is between two separator materials and is not in direct contact with the solution and non-solution portions of the sample.
• a transport container may include a component comprising a plurality of openings (e.g., slots, apertures or receptacles) each having an internal surface configured to accept a sample vessel.
• openings e.g., slots, apertures or receptacles
• such an internal surface may be, at least in part, substantially complementary to the outer surface, or a portion thereof, of a sample vessel.
• the amount of sample in each of the sample vessels does not exceed about 1 ml, or does not exceed about 500 ⁇ ⁇ , or does not exceed about 250 ⁇ ⁇ , or does not exceed about 100 ⁇ ⁇ , or does not exceed about 50 ⁇ ⁇ , or less.
• the vessel holding spaces are configured to hold air-evacuated collection tubes having an interior volume of about 1 ml, or less than about 500 ⁇ ⁇ , or less than about 250 ⁇ ⁇ , or less than about 100 ⁇ ⁇ , or less than about 50 ⁇ ⁇ , or less.
• Figures 2A-2C show perspective views of a sample collection device without a cap according to one embodiment as described herein.
• Figure 12 shows a schematic of a tip portion of a sleeve and associated balance of forces associated with one embodiment as described herein.
• cells encompasses samples that are generally of similar sizes to individual cells, including but not limited to vesicles (such as liposomes), cells, virions, and substances bound to small particles such as beads, nanoparticles, or microspheres. Characteristics include, but are not limited to, size; shape;
• temporal and dynamic changes such as cell movement or multiplication; granularity; whether the cell membrane is intact; internal cell contents, including but not limited to, protein content, protein modifications, nucleic acid content, nucleic acid modifications, organelle content, nucleus structure, nucleus content, internal cell structure, contents of internal vesicles , ion concentrations, and presence of other small molecules such as steroids or drugs; and cell surface (both cellular membrane and cell wall) markers including proteins, lipids, carbohydrates, and modifications thereof.
• the cross-sectional shape of the channel can directly affect the capillary forces.
• a volume of sample can be contained in a shallow but wide channel, or a rounded channel, both containing the same volume, but one might be desirable over the other for filling speed, less possibility of air entrapment, or factors related the performance of the channel.
• the channels 122a, 122b may be supported by the device body 120 and/or the support 130. In some instances, the entire length of the channels may be encompassed within the combination of the device body and the support. In some instances, a portion of the channels may be within the device body and a portion of the channels may be within the support. The position of the channels may be affixed by the device body and/or the support. In some embodiments, the channels may be defined as lumens inside a hollow needle. In some embodiments, the channels are only defined on three sides, with at least one side that is open. Optionally, a cover layer separate from the body may define the side that would otherwise be open. Some embodiments may define different sides of the channel with different materials. These materials can all be provided by the body or they may be provided by different pieces of the collection device. Some embodiments may have the channels all in the same plane.
• the engagement assembly may include a channel holder 350 and/or a force-exerting component, such as a spring 352 or elastic.
• the holder 350 may keep the adapter channel 354 affixed to the support.
• the adaptor channel 354 may be formed integrally with the collection channel or may be a discrete element that may be a stand-alone piece, part of the collection channel, or part of the vessel.
• the holder 350 may prevent the adapter channel 354 from sliding relative to the support.
• the holder 350 may optionally provide a support upon which a force- exerting component, such as a spring, may rest.
• the cap may be formed from a self-healing material, so that when a penetrating member is removed, the opening formed by the penetrating member closes up.
• the second end of the channel may be a penetrating member that may pass through the cap and into the interior of the vessel.
• the penetrating member may be hollow needles that allow sample to pass through, and not just needles for piercing.
• the piercing tip can be a non-coring design such as but not limited to a tapered cannula that pierces without coring the cap material.
• the fluid may travel along the length of the channels to the respective second ends of the channels.
• the channels may be fluidically segregated from one another. For example, a fluid may enter a first channel 722a via a first end 723 a, pass through the length of the channel, and exit the first channel at the second end. Similarly, fluid may enter a second channel 722b via a first end 723 b, pass through the length of the channel, and exit the second channel at the second end.
• the first and second channels may be fluidically segregated so that fluid from the first channel does not pass into the second channel and vice versa. In some embodiments, the fluid may pass to the second ends of the channels without exiting initially.
• a support 730 may have one or more optical indicators, such as optical windows 732a, 732b.
• the optical windows may be positioned over the channels 722a, 722b. In some instances, the optical windows may be positioned over portions of the channels.
• a single window may provide a view to a single channel portion or to multiple channel portions. In one example, the same number of optical windows may be provided as channels. Each optical window may correspond to a respective channel. Both the optical window and channels may be formed of an optically transmissive material that may permit a user to view whether a sample has reached and/or passed through the underlying portion of the channel from outside the sample collection device. Such determination may be useful in determining when to compress the sample collection device.
• multiple but not all channels may be simultaneously contacted to the same sample which is then simultaneously drawn into the respective channels.
• the fluid may be drawn in via capillary action, or any other of the techniques described elsewhere herein.
• the fluid may travel along the length of the channels to the respective second ends of the channels.
• the fluid may reach the second ends of the channels via capillary action or other techniques described herein.
• the fluid need not reach the second ends of the channels.
• the channels may be fluidically segregated from one another.
• the first and second channels may be brought into fluid communication with the first and second vessels simultaneously. Alternatively, they need not be brought into fluid communication simultaneously.
• the timing of the fluid communication may depend on the height of the vessel and/or the length of the channel.
• the timing of the fluid communication may depend on the relative distances between the second end of the channel and the vessel.
• the engagement assembly may include a channel holder and/or a force-exerting component, such as a spring or elastic.
• the holder may keep the channel affixed to the body.
• the holder may prevent the channel from sliding relative to the body.
• the holder may optionally provide a support upon which a force- exerting component, such as a spring, may rest.
• Some time may elapse after a sample has been introduced to a channel for traveling along the length of the channel.
• a user may introduce a sample to the sample collection device and may wait for the sample to travel the length of the channel.
• One or more optical indicator along the length of the channel may be provided, which may indicate whether the sample has reached the end of the channel.
• the user may wait a predetermined amount of time before pushing in the body.
• the body may be pushed in after the user has determined the sample has traveled a sufficient length of the channel and/or a sufficient amount of time has passed since the sample was introduced.
• the body may have a flat surface which may be easy for the user to push.
• a user may separate the base 940 from the support 930 to bring the device into a separated state to remove the vessels therein.
• the base may be separated from the support or vice versa. Separating the base from the support may expose the vessels 946a, 946b that are supported by the base.
• the vessels may be press-fit or otherwise held within the base.
• the vessels 946a, 946b may be removable from the base. By way of non-limiting example, removing the vessels 946a, 946b allows them to be placed with other vessels in a climate controlled transport container for transport to a receiving site such as but not limited to an analysis site.
• FIG. 1 IE an enlarged cross-sectional view of the device 1100 is shown.
• This embodiment shows that the support 1130 has a lip portion 1136 sized to extend over the adapter channels 1150 and 1152 in an amount sufficient to prevent a user from inserting a finger into the gap 1154 and piercing the finger on one of the needle.
• the present embodiment has at least two channels in the sample collection device 1100. This allows for each of the channels 1128 and 1126 to each introduce a different material into the sample.
• each of the channels 1128 and 1126 can introduce heparin into the blood while another channel introduces ethylenediaminetetraacetic acid (EDTA).
• EDTA ethylenediaminetetraacetic acid
• a channel of volume from 20 to 30 ⁇ can be coated by Heparin in the range from 250 units/mL Heparin.
• the material may be solution coated onto the target surface for less than 1 hour and then dried overnight.
• Figure 11 J also shows that in the one or more embodiments herein, there may be angled side wall features 1167 that conically or otherwise narrow the cross-sectional area of the channel in a manner that funnels sample to minimize the amount of sample that may be retained in the channel and not collected.
• Figure 11 J also shows that there may be locating feature(s) 1169 to facilitate joining of parts together in a define location and orientation during
• FIG. HQ shows that in some embodiments, the vessel holder 1140 can be shaped asymmetrically (in the cross-sectional plane) or otherwise shaped to enable only one orientation that the holder 1140 can be received in the device 1160. This can be particularly desirable when it is desired to direct sample from a certain channel into a selected vessel. If the holder 1140 can be inserted in various orientations, the sample from one channel may end up in the wrong vessel.
• other features such as alignment features, slots, visual cues, texture cues, and/or the like may be used to encourage a preferred orientation of sample vessels in the device.
• FIG. 11R yet another embodiment of a sample collection device will now be described.
• This sample collection device 1210 comprises features similar to that shown in Figure 11G, except that it further includes a tissue penetrating member 1212 that is mounted to the sample collection device 1210.
• An actuation mechanism 1214 such as but not limited to a spring actuator can be used to launch the tissue penetrating member.
• Figure 11R shows the actuation mechanism 1214 in a resting state and that it can be a spring that can be compressed to launch a tissue penetrating member 1212 towards target tissue.
• the tissue penetrating member 1212 can be housed inside a housing 1216 (shown in phantom).
• FIG. 11U yet another embodiment of a sample collection device will now be described.
• This embodiment is similar to that of Figure 1 IT except that, instead of single tissue penetrating member such as a lancet, the embodiment of Figure 1 IT uses a plurality of tissue penetrating members 1242.
• these tissue penetrating members are microneedles 1242 that are of reduced diameter as compared to traditional lancets.
• a plurality of microneedles 1242 can be simultaneously actuated for device 1240 and create multiple wound sites on the tissue.
• the spacing of the microneedles 1242 can result in more capillary loops being pierced and more channels being available for blood to reach the tissue surface.
• the sample collection device 1100 may be mounted angled to a dedicated wound creation device 1250 that has a tissue penetrating member 1252 configured to extend outward from the device 1250.
• the sample collection device 1100 which may optionally be configured to have a shaped front end 1236 (with or without an opening to accommodate the tissue penetrating member 1252), can be removably mounted to the wound creation device 1250.
• the sample collection device 1100 may be flat mounted to the device 1250.
• some embodiments may introduce teeth- or finger-like structures within the capillary in order increase surface are in the cross-section of the capillary.
• some embodiments may include fins oriented toward and/or against the fluid flow within the capillary in order increase surface are in the cross-section of the capillary.
• sample fluid may be applied or dropped into the collection location 1322 as indicated by droplet D.
• some may directly apply or directly contact the collection location 1322 to apply the sample fluid.
• the embodiments herein are shown to use only a single collection location 1322, it should be understood that other embodiments where multiple channels couple to a common sample collection point are envisioned.
• one embodiment of a collection device may have two collection locations 1322, each with its own set of channels leading away from its respective collection location.
• Some embodiments may combine common collection point channels shown in Figures 13A-B with channels that are separate such as shown in Figures 11 A-l IF. Other combinations of common collection location structure with other structures with separate channels are not excluded.
• Figures 16 and 17 show examples of identifiers provided for use with a sample collection device 1300 in accordance with an embodiment described herein.
• a sample collection device may include a base 1340 which may support and/or contain one or more vessels 1346a, 1346b. Sample may be provided to the sample collection device. The sample may be provided to the sample collection device via an inlet 1322. The sample may travel to one or more vessels 1346a, 1346b within the device.
• the sample fluid may be extracted from the patient using a sample collection device such as but not limited to that described in U.S. Patent Application Ser. No. 61/697,797 filed September 6, 2012 and U.S. Patent Application Ser. No. 61/798,873 filed March 15, 2013, both of which are fully incorporated herein by reference for all purposes.
• some embodiments may collect the blood sample through collection of capillary blood from the subject. This may occur by way of a wound, a penetration site, or other access site to capillary blood from the subject.
• blood could also be collected by venipuncture or other puncture of a blood vessel to obtain blood sample for loading into the sample vessel(s).
• a subject's finger may be punctured to yield a bodily fluid.
• the bodily fluid may be collected using a capillary tube, pipette, swab, drop, or any other mechanism known in the art.
• the capillary tube or pipette may be separate from the device and/or a cartridge of the device that may be inserted within or attached to a device, or may be a part of a device and/or cartridge.
• a subject can simply provide a bodily fluid to the device and/or cartridge, as for example, with a saliva sample.
• a bodily fluid may be drawn from a subject and provided to a device in a variety of ways, including but not limited to, fingerstick, lancing, injection, and/or pipetting.
• the bodily fluid may be collected using venous or non-venous methods.
• the bodily fluid may be provided using a bodily fluid collector.
• a bodily fluid collector may include a lancet, capillary, tube, pipette, syringe, venous draw, or any other collector described elsewhere herein.
• a lancet punctures the skin and withdraws a sample using, for example, gravity, capillary action, aspiration, or vacuum force.
• the lancet may be part of the device, part of the cartridge of the device, part of a system, or a standalone component. Where needed, the lancet may be activated by a variety of mechanical, electrical, electromechanical, or any other known activation mechanism or any combination of such methods.
• a subject's finger or other portion of the subject's body
• the bodily fluid may be collected using a capillary tube, pipette, or any other mechanism known in the art.
• the sample vessel body may have a tubular shape.
• the sample vessel body may have a cylindrical portion.
• the sample vessel may have a circular cross-sectional shape.
• the sample vessel may have any other cross-sectional shape which may include elliptical, triangular, quadrilateral (e.g., square, rectangular, trapezoidal, parallelogram), pentagonal, hexagonal, heptagonal, octagonal, or any other shape.
• the cross-sectional shape of the sample vessel may or may not have a convex and/or concave shape.
• the cross-sectional shape of the sample vessel may remain the same along the length of the sample vessel, or may vary.
• the sample vessel may have a prismatic shape along the length of the body.
• the prism may have a cross-sectional shape as those described herein.
• the greatest dimension of the sample vessel may be no greater than 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0.1 cm, 700 um, 500 m, 300 um, 100 um, 70 um, 50 um, 30 um, 10 um, 7 um, 5 um, 30 um, or 1 um.
• the cap may be configured to engage with the sample vessel body in any manner.
• the cap may be press-fit with the sample vessel body.
• a friction fit and/or interference fit may permit the cap to stay on the body.
• a locking mechanism may be provided, such as a sliding mechanism, clamp, fastener, or other technique.
• the cap and/or the sample vessel body may be threaded to permit a screw-type engagement.
• adhesives, welding, soldering, or brazing may be utilized to connect the cap to the sample vessel body.
• the cap may be removably attached to the sample vessel body.
• the cap may be permanently affixed to the sample vessel body.
• sample vessels may contain a blood clotting activator (e.g. thrombin, silica particles, glass particles), an antiglycolytic agent (e.g. sodium floride), or a gel to facilitate the separation of blood cells from plasma.
• sample vessels may contain sodium polyanethol sulfonate (SPS), acid citrate dextrose additives, perchloric acid, or sodium citrate.
• SPS sodium polyanethol sulfonate
• acid citrate dextrose additives e.g. sodium floride
• sample vessels may contain sodium polyanethol sulfonate (SPS), acid citrate dextrose additives, perchloric acid, or sodium citrate.
• the coating may be a wet or dry coating. Some embodiments may have at least one dry coating and at least one wet coating. In some instances one or more reagents may be coated and dried on the interior surface of the sample vessel. The coating may alternatively be provided in a moist environment or may be a gel. Some embodiments may include a separator gel in the sample vessel to keep select portions of the sample away from other portions of the sample. Some embodiments may include serum separator gel or plasma separator gel such as but not limited to polyester-based separator gels available from Becton Dickinson.
• one or more solid substrates may be provided within the sample vessel.
• one or more beads or particles may be provided within the sample vessel.
• the beads and/or particles may be coated with reagents or any other substance described herein.
• the beads and/or particles may be capable of dissolving in the presence of the sample.
• the beads and/or particles may be formed from one or more reagents or may be useful for treating the sample.
• a reagent may be provided in a gaseous form within the sample vessel.
• the sample vessel may be sealed.
• the sample vessel may remain sealed before the sample is introduced into the sample vessel, after the sample has been introduced to the sample vessel, and/or while the sample is being introduced into the sample vessel.
• the sample vessels may have smooth surfaces and/or round bottoms. This is helpful to minimize the stress on the blood sample, especially during centrifugation. Of course, in alternative embodiments, other shapes of the bottom of the sample vessel are not excluded.
• a bodily fluid sample in a sealed sample vessel may retain analytes in the bodily fluid sample, such that sample stored in the sealed sample vessel retains an analyte composition similar to or the same as that of bodily fluid sample freshly extracted from a subject's body or of a freshly prepared bodily fluid sample (e.g. plasma freshly prepared from whole blood).
• an information storage unit may provide unique identification, or may provide a high likelihood of providing unique identification.
• the information storage unit may have a visible component.
• the information storage unit may be optically detectable.
• the information storage unit may be discernible using visible light.
• the information storage unit may be a barcode (e.g., 1-D, 2-D, or 3-D), quick response (QR) code, image, shape, word, number, alphanumeric string, color, or any combination thereof, or any type of visual information storage unit.
• the information storage units may be provided with sample vessels housed by the holder. Separating the holder from the rest of the sample collection device may cause the sample vessels to be separated from the rest of the sample collection device.
• the sample vessels may remain within the holder or may be removed from the holder.
• the information storage units may remain with the sample vessels even if they are removed from the holder. Alternatively, the information storage units may remain with the holder even if sample vessels are removed.
• both the holder and sample vessels may have information storage units so that the sample vessels and holders may be individually tracked and/or matched even when separated.
• this embodiment shows the openings 1910 and 1912 configured to be coaxial, relative to one another. This coaxial configuration of openings 1910 and 1912 allows for greater overlap between the two openings.
• the flexible tubing 2106 allows the needle portion 2104 to be located away from but still operably fluidly coupled to the sample collection device 2100. This allows for greater flexibility in terms of positioning of the needle 2104 to acquire sample fluid without having to also move the sample collection device 2100.
• some embodiments may directly couple the tissue penetrating member to the device 2100 without the use of flexible tubing.
• Figure 30 shows a bodily fluid sample B on a skin surface S of the subject.
• the bodily fluid sample B can be collected by one of a variety of devices.
• collection device 1530 may be but is not limited to those described in U.S. Patent Application Ser. No. 61/697,797 filed September 6, 2012, which is fully incorporated herein by reference for all purposes.
• the bodily fluid sample B is collected by one or more capillary channels and then directed into sample vessels 1540.
• this storage can be temporary during collection, longer term such as for transport from collection site to refrigeration, from collection site to receiving site, other location to location transport, or other purpose.
• One embodiment can be configured to have caps that go on both ends of the device so that sample is contained therein without need for transferring to vessels 1146a and 1146b.
• the largest dimension of the transport container may be no greater than about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.7 cm, 0.5 cm, 0.3 cm, or 1 mm.
• the top cover and the housing may or may not form an airtight seal.
• the top cover and/or housing may be formed from a material with a desired thermal
• Inner could be formed with a different technique as it is may not be critical for the interior to be cosmetically appealing.
• cast molding or other lower temperature molding process could also be used in place of or in combination with injection molding of the PCM integrated transport container material.
• Embedded PCM could also be in the trays. Some embodiments could be a tray that is much more thermally conductive to achieve even, uniform cooling profile.
• the PCM material is contained in a chamber inside the chassis of the transport container, wherein the wall of the chamber may be thinner than wall thickness of other areas of the shipping box chassis.
• Figure 39 shows a plurality of views of the transport container 3200.
• the sample vessel holders in the trays 3230a or 3230b may have open bottoms such that any information storage unit, such as but limited to a barcode or other information storage unit, can be read from underneath or other orientation that does not require that sample vessels be removed from the transport container 3200.
• any information storage unit such as but limited to a barcode or other information storage unit
• only certain portions of the transport container 3200 such as but not limited to a layer, a tray, or the like is removed to obtain the desired information.
• bar codes or other information storage units can be accessed through one or more openings in the tray. That allows for bar code scanning of very small transport container.
• the shapes of the holders may also be designed to follow the contours of the sample vessels 3134 therein to increase surface area contact and improve thermal control of the sample vessels.
• thermal control of the sample vessels may occur through thermal transfer with tray and/or the PCM, but not in direct contact with the PCM.
• some sample vessels 3134 could also be in direct contact with the vessel and/or the PCM.
• the openings for the sample vessels and/or the holders may be in linear rows, in a honeycomb pattern, or be in another pattern.
• Figure 40B shows a plurality of sample vessels 3134 such as those associated with the sample collection device.
• the sample vessels 3134 can all be from sample associated with one subject in which case an information storage unit associated with tray 3230a can be used to provide information about this group of samples.
• individual sample vessels may still each have an information storage unit that is the same as that of the tray 3230a or they may each be unique.
• Some embodiments may insert sample vessels from multiple subjects into the same tray 3230a.
• some may only partially fill each tray. Some may fill each opening in the tray, but not every sample vessel will have sample therein (i.e. some may be empty sample vessels inserted to provide uniform thermal profile).
• Figure 41 shows the sample vessels 3306 are held in an array configuration, other predetermined configurations are not excluded. Some may place the sample vessels into hinged, swinging, or other retaining mechanism in the tray that may allow for motion in one or two degrees of freedom. Some embodiments may place the sample vessels into a device that has first configuration during loading and then assumes a second configuration to retain the sample vessels during transport. Some embodiments may place the sample vessels into a material that has first material property during loading and then assumes a second property such as but not limited to hardening to retain the sample vessels during transport.
• this embodiment of transport container 3300 may have some retaining mechanism 3320 such as but not limited to clips, magnetic areas, or the like to hold the tray 3306.
• the retaining mechanism 3320 may be configured to hold the tray 3304 in a manner releasable when desired.
• the retaining mechanism 3320 may be configured to hold the tray 3304 in an un-releasable manner.
• the retaining mechanism 3320 is shown as magnetic and/or metallic members in tray 3304 that are attracted to metal and/or magnetic members in the transport container 3300.
• the tray 3304 may be configured to be removed from the transport container 3300.
• sample vessels containing a sample may also contain an anticoagulant.
• the anticoagulant may be dissolved in the sample or otherwise present in the vessel (e.g. dried on one or more interior surfaces of the vessel or in solid form at the bottom of the vessel).
• a sample vessel containing a sample may have a "total anticoagulant content", wherein the total anticoagulant content is the total amount of anticoagulant present in the interior volume of the vessel, and includes anticoagulant dissolved in the sample (if any), as well as anticoagulant in the vessel which is not dissolved in the sample (if any).
• a sample vessel containing a sample may contain no more than 1 ml sample and have a total anticoagulant content of no more than 15 USP units heparin, may contain no more than 750 ⁇ sample and have a total anticoagulant content of no more than 11 USP units heparin, may contain no more than 500 ⁇ sample and have a total anticoagulant content of no more than 7.5 USP units heparin, may contain no more than 400 ⁇ sample and have a total anticoagulant content of no more than 6 USP units heparin, may contain no more than 300 ⁇ sample and have a total anticoagulant content of no more than 4.5 USP units heparin, may contain no more than 200 ⁇ sample and have a total anticoagulant content of no more than 3 USP units heparin, may contain no more than 150 ⁇ sample and have a total anticoagulant content of no more than 2.3 USP units heparin, may contain no more than 100 ⁇ sample and have a total anticoagulant content of no
• a total volume of bodily fluid sample may be obtained from a subject.
• the total volume of bodily fluid sample may be transferred into a single sample vessel, or into two or more sample vessels.
• a total volume of 500 microliters of bodily fluid sample may be obtained from a subject, and it may be transferred into a single sample vessel, wherein the single sample vessel has a maximum interior volume of 600 microliters.
• a total volume of 500 microliters of bodily fluid sample may be obtained from a subject, and it may be transferred into a two sample vessels, wherein each sample vessel has a maximum interior volume of 300 microliters.
• the first location and the second location may be within the same room, building, campus, or collection of buildings.
• a first location and second location may be separated by at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers.
• a first location and second location may be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, 500 kilometers, or 1000 kilometers.
• FIG. 44 shows the collection of bodily fluid sample from a surface of the subject
• other alternative embodiments may use collection techniques for collecting sample from other areas of the subject, such as by venipuncture, to fill the sample vessel(s) 3540.
• Such other collection techniques are not excluded for use as alternative to or in conjunction with surface collection.
• Surface collection may be on exterior surfaces of the subject.
• some embodiments may collect from accessible surfaces on the interior of the subject. Presence of bodily fluid sample B on these surfaces may be naturally occurring or may occur through wound creation or other techniques to make the bodily fluid surface accessible.
• some embodiments may not have a chamber 3554 but instead have very little void space other than channel(s), pathway(s), or tube(s) used to direct sample from the needle 3552 to the sample vessel(s) 3540.
• the pressure from within the blood vessel is such that the blood sample can fill the chamber 554 without much if any assistance from the collection device.
• Such embodiments may optionally include one or more vents, such as but not limited to a port, to allow air escape as the channels in the collection device are filled with sample.
• the sample portions in some or each of the sample vessels may contain a different anticoagulant or other additive.
• no more than a total volume of 300 microliters of bodily fluid sample from a subject may be used for performing two or more of the tests, wherein at least one portion of the no more than 300 microliter sample is mixed with first anti-coagulant and a second portion of the no more than 300 microliter sample is mixed with a second anti-coagulant different from the first.
• each portion of the no more than 300 microliter sample is in its own sample vessel.
• a bay may be configured to accept a subset of the types of modules the system 700 is configured to use.
• a bay may be configured to accept a module capable of running an agglutination assay but not a cytometry assay.
• the module may be "specialized" for agglutination.
• Agglutination may be measured in a variety of ways. Measuring the time-dependent change in turbidity of the sample is one method. One can achieve this by illuminating the sample with light and measuring the reflected light at 90 degrees with an optical sensor, such as a photodiode or camera. Over time, the measured light would increase as more light is scattered by the sample.
• the first, second, third, fourth, fifth, and sixth modules 701-706 include a positive displacement pipette and suction-type pipette and various assays, such as a nucleic acid assay and
• the first, second, third, and/or fourth modules 701-706 may be replaced by one or more other modules that can occupy the location of the module being replaced.
• the other modules may optionally provide different functionality such as but not limited to a replacing one of the modules 701-706 with one or more cytometry modules 707, communications modules, storage modules, sample preparation modules, slide preparation modules, tissue preparation modules, or the like.
• the communication bus may be a wireless bus.
• the commuplexions bus may be a Firewire (IEEE 1394), USB (1.0, 2.0, 3.0, or others), Thunderbolt, or other protocols (current or developed in the future).
• the system 700 includes a Serial Peripheral Interface (SPI), which is an interface between one or more microprocessors and peripheral elements or I/O components (e.g., modules 701-706) of the system 700.
• SPI Serial Peripheral Interface
• the SPI can be used to attach 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7 or more, or 8 or more, or 9 or more, or 10 or more or 50 or more or 100 or more SPI compatible I/O components to a microprocessor or a plurality of microprocessors.
• the system 700 includes RS-485 or other standards.
• an SPI is provided having an SPI bridge having a parallel and/or series topology.
• Such a bridge allows selection of one of many SPI components on an SPI I/O bus without the proliferation of chip selects. This is accomplished by the application of appropriate control signals, described below, to allow daisy chaining the device or chip selects for the devices on the SPI bus. It does however retain parallel data paths so that there is no Daisy Chaining of data to be transferred between SPI components and a microprocessor.
• SPI CS/ (which may be referred to as SS/) is routed to one of 4 possible bridged devices, per the true state of either CS4, CS3, CS2 or CSl.
• Jumper bits ADO, AD 1 are compared to ADO, ADl of the control register allow up to four SPI-Bridges on a module.
• One embodiment shows a device having a plurality of modules mounted on a SPI link of a communications bus of the device, in accordance with an embodiment of the invention.
• Three modules are illustrated, namely Module 1, Module 2 and Module 3.
• Each module includes one or more SPI bridges for bringing various components of a module in electrical connection with the SPI link, including a master controller (including one or more CPU's) in electrical communication with the SPI link.
• Module 1 includes a plurality of SPI slaves in electrical communication with each of SPI Bridge 00, SPI Bridge 01, SPI Bridge 10 and SPI Bridge 11.
• each module includes a Receive Data controller, Transmit Data controller and Module ID jumpers.
• Devices and methods provided herein, by enabling parallel processing, may advantageously decrease the energy or carbon footprint of point of service systems.
• systems such as the system 700 of FIG. 55C, has a footprint that is at most 10%, or 15%, or 20%, or 25%, or 30%, or 35%, or 40%, or 45%, or 50%, or 55%, or 60%, or 65%, or 70%, or 75%, or 80%, or 85%, or 90%, or 95%, or 99% that of other point of service systems.
• a method for processing a sample with the aid of a point of service system comprises accepting testing criteria or parameters and determining a test order or schedule based on the criteria.
• the testing criteria is accepted from a user, a system in communication with the point of service system, or a server.
• the criteria are selectable based on a desired or predetermined effect, such as minimizing time, cost, component use, steps, and/or energy.
• the point of service system processes the sample per the test order or schedule.
• a feedback loop (coupled with sensors) enables the point of service system to monitor the progress of sample processing and maintain or alter the test order or schedule.
• resource/component utilization modifications one or more detected error or alert condition, one or more unavailability of a resource and/or component, one or more subsequent input or sample provided by a user, external data, or any other reason.
• the transport container 4000 may be configured to contain therein a plurality of bodily fluid samples from a plurality of subjects such as patients. In some embodiments there are multiple vessels of sample from each subject.
• At least two of the samples from the same subject have had different chemical pre- treatment, such as but not limited to different anti-coagulant in each vessel.
• some embodiments may use a vessel that has two or more separate chambers, wherein each chamber is configured to hold a portion of the fluid sample separate from fluid sample in another chamber.
• Some embodiments may include samples from a subject in single chamber vessels and/or multi- chamber vessels.
• FIGs 56A and 56B various views of one embodiment of the transport container 4000 wherein the lid 4010 has a least a mesa portion 4012 that is sized to fit into a recess 4020 on the bottom of the transport container4000 as seen in Figure 57A so that the vessels 4000 may be stackable.
• the transport container4000 may have any of the features described herein for other embodiments of transport containers described herein.
• Figure 57B shows that there may be a tray 4030 in the transport container4000 that is fixed and/or removable from the transport container4000.
• the tray 4030 is held in place by a fixture device such as but not limited to magnetic or metal portions 4032 that align with metal or magnetic portions in the chassis of the transport container4000 to form a magnetic connection.
• a fixture device such as but not limited to magnetic or metal portions 4032 that align with metal or magnetic portions in the chassis of the transport container4000 to form a magnetic connection.
• the length-to-width aspect ratio is in the range of about to 128:86 to 127:85.
• the length-to-width aspect ratio is in the range of about to 130:90 to 120:80.
• the length of the tray is in the range of about to 130mm to 120mm and the width is in the range of about 90mm to 80mm.
• the height or thickness of the tray is in the range of about 14 to 20 mm.
• the aspect ratio and/or size is configured to hold a tray that is sized to fit a slot, recess, or other holder on a plate centrifuge. In this manner, the entire tray 4030 can be centrifuged to prepare a plurality of the samples therein.
• the process may optionally include complete or substantially complete plasma separation of the sample at a sample collection location, such as but not limited to a remote location different from the analysis site, a patient service center (PSC), or a retail site such as a pharmacy, such that the primary separation process of formed components from liquid component(s) allows for no more or minimal plasma being pushed out from a formed component such as but not limited to the red blood cells through a separator gel between layers of the formed and liquid components at a later time, such as during any second or subsequent separation step after the primary separation step.
• a sample collection location such as but not limited to a remote location different from the analysis site, a patient service center (PSC), or a retail site such as a pharmacy, such that the primary separation process of formed components from liquid component(s) allows for no more or minimal plasma being pushed out from a formed component such as but not limited to the red blood cells through a separator gel between layers of the formed and liquid components at a later time, such as during any second or subsequent separation step after the primary separation step.
• the method comprises a primary accelerated sedimentation force such as but not limited to a centrifugation step of at least about 3700g.
• the method comprises a primary accelerated sedimentation force such as but not limited to a centrifugation step of at least about 3800g.
• the method comprises a primary accelerated sedimentation force such as but not limited to a centrifugation step of at least about 3900g.
• the method comprises a primary accelerated sedimentation force such as but not limited to a centrifugation step of at least about 3950g.
• the g-force generated in the primary centrifugation step may have a force selected from a range having a minimum value of about 3000g, 3100g, 3200g, 3300g, 3400g, 3500g, 3600g, 3700g, 3800g, 3900g, or 3950g, and a maximum value of 3100g, 3200g, 3300g, 3400g, 3500g, 3600g, 3700g, 3800g, 3900g, or 3990g.
• the minimum force may be at least 1400g.
• the minimum force may be at least 1500g.
• the minimum force may be at least 1600g. In at least one embodiment, for any of the foregoing, the minimum force may be at least 1700g. In at least one embodiment, for any of the foregoing, the minimum force may be at least 1800g. In at least one embodiment, for any of the foregoing, the minimum force may be at least 1900g. In at least one embodiment, for any of the foregoing, the minimum force may be at least 2000g.
• "g" is in reference to the acceleration of gravity at sea level on Earth, which is about 9.8 m/s 2 .
• the first or primary separation step to separate the plasma from the red blood cells occurs within 5 min of sample being collected into sample container(s).
• the first or primary separation step to separate the plasma from the red blood cells occurs within 10 min of sample being collected into sample container(s).
• the first or primary separation step to separate the plasma from the red blood cells occurs within 15 min of sample being collected into sample container(s).
• the first or primary separation step to separate the plasma from the red blood cells occurs within 20 min of sample being collected into sample container(s).
• the first or primary separation step to separate the plasma from the red blood cells occurs nor more than about 5 minutes after the sample being collected into sample container(s).
• an original sample may be plasma or serum obtained from whole blood sample obtained from a subject.
• the whole blood may be obtained from a subject's digit.
• the whole blood sample from which the plasma or serum is obtained may have a volume of no greater than 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliters.
• the plasma or serum original sample may have a volume of no greater 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 microliters.
• the original sample may be divided into multiple portions.
• a bodily fluid sample or portion thereof transported according to a system or method provided herein may be used in an immunoassay.
• an "immunoassay” refers to any assay which involves probing for an analyte with an antibody which has affinity for the analyte.
• Immunoassays may include, for example, enzyme- linked immunosorbent (ELISA) assays and may include competitive and non-competitive based- assays.
• ELISA enzyme- linked immunosorbent
• antibody refers to immunoglobulin molecules and
• General chemistry assays may also be, for example, colorimetric assays, enzymatic assays, spectroscopic assays, turbidimetric assays, agglutination assays, coagulation assays, and/or other types of assays. Many general chemistry assays may be analyzed by measuring the absorbance of light at one or more selected
• Such characteristics include but are not limited to size; shape; granularity; light scattering pattern (or optical indicatrix); whether the cell membrane is intact; concentration, morphology and spatio-temporal distribution of internal cell contents, including but not limited to protein content, protein modifications, nucleic acid content, nucleic acid modifications, organelle content, nucleus structure, nucleus content, internal cell structure, contents of internal vesicles (including pH), ion concentrations, and presence of other small molecules such as steroids or drugs; and cell surface (both cellular membrane and cell wall) markers including proteins, lipids, carbohydrates, and modifications thereof.
• cytometry may be used to determine the presence, quantity, and/or modifications of specific proteins, nucleic acids, lipids, carbohydrates, or other molecules. Cytometric analysis may, for example, be by flow cytometry or by microscopy.
• Flow cytometry typically uses a mobile liquid medium that sequentially carries individual cells to an optical, electrical or acoustic detector.
• Microscopy typically uses optical or acoustic means to detect stationary cells, generally by recording at least one magnified image.
• a cytometry assay may involve obtaining images of one or more cells in a sample.
• laboratory test types may be classified based on how the results of the test are detected.
• Different types of laboratory test result detection may include, for example, i) luminescence detection; ii) fluorescence detection; iii) absorbance detection; iv) light scattering detection; and v) imaging.
• luminescence detection may be detected from tests which yield a measurable light signal. Such reactions may be, for example, chemiluminescent reactions.
• a light detector such as a PMT or photodiode may be used to detect light from an assay unit containing a luminescent reaction. Fluorescence may be detected, for example, with an optical set up which includes a light source and a light detector.
• the light source may emit light of a particular wavelength(s).
• An assay unit containing the test material may be situated in the path of the light source, such that light of the particular wavelength(s) reaches the contents of the assay unit ("excitation wavelength(s)").
• the assay unit may contain a molecule of interest which, at least under some circumstances, absorbs light at the particular wavelength(s) from the light source, and, subsequently, releases light of a different wavelength.
• Light scattering may be detected, for example, with an optical set up which includes a light source and a light detector.
• the light source and light detector may be situated at an angle relative to each other, and configured such that an assay unit containing the test material may be situated in line with both the light source and light detector, such that light from the light source may reach the assay unit and be scattered by test material in the assay unit, to reach the light detector. Different amounts of light may be scattered by the test material, based on the outcome of the test.
• the light source may be, for example, a light bulb, a laser or an LED
• the image sensor will be included in a camera. Images of test material may be analyzed, for example, by automated or manual image analysis, in order to determine test results. Bodily fluid samples as provided herein may also be used in laboratory tests which detect results through non-optical based detection methods (e.g. measurements of conductivity, radioactivity, or temperature).
• an antibody for the analyte, a target nucleic acid in the sample being amplified in a nucleic acid amplification reaction, a sample coagulating based on the addition of one or more reagents to the sample, or a sample adopting a configuration for optical analysis (e.g. cells settling on a surface of a microscope slide in order to facilitate obtaining one or more images of the cells).
• assay and “test” may be used interchangeably, unless the context clearly dictates otherwise.
• a device for collecting a bodily fluid sample from a subject comprising: at least two sample collection pathways configured to draw the bodily fluid sample into the device from a single end of the device in contact with the subject, thereby separating the fluid sample into two separate samples; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathways, the sample vessels operably engagable to be in fluid communication with the sample collection pathways, whereupon when fluid communication is established, the vessels provide a motive force to move a majority of the two separate samples from the pathways into the vessels.
• a device for collecting a bodily fluid sample comprising: a first portion comprising at least one fluid collection location leading to at least two sample collection pathways configured to draw the fluid sample therein via a first type of motive force; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathways, the sample vessels operably engagable to be in fluid communication with the sample collection pathways, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the pathways into the vessels; wherein at least one of the sample collection pathways comprises a fill indicator to indicate when a minimum fill level has been reached and that at least one of the sample vessels can be engaged to be in fluid communication with at least one of the sample collection pathways.
• a device for collecting a bodily fluid sample comprising a first portion comprising at least two sample collection channels configured to draw the fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an interior coating designed to mix with the fluid sample and another of the sample collection channels has another interior coating chemically different from said interior coating; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channels, the sample vessels operably engagable to be in fluid communication with the collection channels, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channels into the vessels; wherein vessels are arranged such that mixing of the fluid sample between the vessels does not occur.
• a device for collecting a bodily fluid sample comprising: a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw the fluid sample into each of the at least two sample collection channels via a first type of motive force; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channels, wherein the sample vessels have a first condition where the sample vessels are not in fluid communication with the sample collection channels, and a second condition where the sample vessels are operably engagable to be in fluid communication with the collection channels, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move bodily fluid sample from the channels into the vessels.
• a sample collection device comprising: (a) a collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid sample via capillary action from the first opening towards the second opening; and (b) a sample vessel for receiving the bodily fluid sample, the vessel being engagable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; wherein the second opening is defined by a portion the collection channel configured to penetrate the cap of the sample vessel, and to provide a fluid flow path between the collection channel and the sample vessel, and the sample vessel has an interior volume no greater than ten times larger than the interior volume of the collection channel.
• a sample collection device comprising: (a) a collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid sample via capillary action from the first opening towards the second opening; (b) a sample vessel for receiving the bodily fluid sample, the vessel being engagable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) an adaptor channel configured to provide a fluid flow path between the collection channel and the sample vessel, having a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, the second opening being configured to penetrate the cap of the sample vessel.
• a sample collection device comprising: (a) a body, containing a collection channel , the collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid via capillary action from the first opening towards the second opening; (b) a base, containing a sample vessel for receiving the bodily fluid sample, the sample vessel being engagable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) a support, wherein, the body and the base are connected to opposite ends of the support, and are configured to be movable relative to each other, such that sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the extended state of the device than in the compressed state, the second opening of the collection channel is configured to penetrate the cap of the sample vessel, in the extended state of the device, the second opening of the collection channel is not in contact with
• a sample collection device comprising: (a) a body, containing a collection channel , the collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid via capillary action from the first opening towards the second opening; (b) a base, containing a sample vessel for receiving the bodily fluid sample, the sample vessel being engagable with the collection channel, having an interior with a vacuum therein and having a cap configured to receive a channel; (c) a support, and (d) an adaptor channel, having a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the cap of the sample vessel, wherein, the body and the base are connected to opposite ends of the support, and are configured to be movable relative to each other, such that sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the extended
• a device for collecting a fluid sample from a subject comprising: (a) a body containing a collection channel, the collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid via capillary action from the first opening towards the second opening; (b) a base, engagable with the body, wherein the base supports a sample vessel, the vessel being engagable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; wherein the second opening of the collection channel is configured to penetrate the cap of the sample vessel, and to provide a fluid flow path between the collection channel and the sample vessel.
• a device for collecting a fluid sample from a subject comprising: (a) a body containing a collection channel, the collection channel comprising a first opening and a second opening, and being configured to draw a bodily fluid via capillary action from the first opening towards the second opening; (b) a base, engagable with the body, wherein the base supports a sample vessel, the sample vessel being engagable with the collection channel, having an interior with a vacuum therein and having a cap configured to receive a channel; and (c) an adaptor channel, having a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the cap of the sample vessel.
• anticoagulant is different from heparin.
• one anticoagulant is heparin and the second anticoagulant is EDTA.
• one anticoagulant is heparin and the second anticoagulant is citrate.
• one anticoagulant is citrate and the second anticoagulant is EDTA.
• each collection channel can hold a volume of no greater than 500 uL.
• each collection channel can hold a volume of no greater than 200 uL.
• each collection channel can hold a volume of no greater than 100 uL.
• each collection channel can hold a volume of no greater than 70 uL.
• each collection channel can hold a volume of no greater than 500 uL.
• each collection channel can hold a volume of no greater than 30 uL.
• the internal circumferential perimeter of a cross-section of each collection channel is no greater than 16 mm.
• the internal circumferential perimeter of a cross-section of each collection channel is no greater than 8 mm.
• the internal circumferential perimeter of a cross- section of each collection channel is no greater than 4 mm.
• the internal circumferential perimeter of a cross-section of each collection channel is no greater than 16 mm.
• the internal circumferential perimeter of a cross-section of each collection channel is no greater than 8 mm.
• the device comprises a first and a second collection channel, and the opening of the first channel is adjacent to an opening of said second channel, and the openings are configured to draw blood simultaneously from a single drop of blood.
• the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm.
• each sample vessel has an interior volume no greater than twenty times larger than the interior volume of the collection channel with which it is engagable.
• each sample vessel has an interior volume no greater than ten times larger than the interior volume of the collection channel with which it is engagable.
• establishment of fluidic communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and in no more than five ⁇ _, of bodily fluid sample remaining in the collection channel.
• engagement of the collection channel with the sample vessel results in transfer of the bodily fluid sample into the sample vessel and in no more than 2 ⁇ _, of bodily fluid sample remaining in the collection channel.
• a method comprising contacting one end of a sample collection device to a bodily fluid sample to split the sample into at least two portions by drawing the sample into at least two collection channels of the sample collection device by way of a first type of motive force; establishing fluid communication between the sample collection channels and the sample vessels after a desired amount of sample fluid has been confirmed to be in at least one of the collection channels, whereupon the vessels provide a second motive force different from the first motive force to move each of the portions of bodily fluid sample into their respective vessels.
• a method of manufacturing a sample collection device comprising forming one portion of a sample collection device having at least two channels configured to simultaneously draw the fluid sample into each of the at least two sample collection channels via a first type of motive force; forming sample vessels, whereupon the vessels are configured to be coupled to the sample collection device to the provide a second motive force different from the first motive force use to collect the samples to move bodily fluid sample from the channels into the vessels.
• computer executable instructions are provided for performing a method comprising: forming one portion of a sample collection device having at least two channels configured to simultaneously draw the fluid sample into each of the at least two sample collection channels via a first type of motive force.
• computer executable instructions for performing a method comprising: forming sample vessels, whereupon the vessels are configured to be coupled to the sample collection device to provide a second motive force different from the first motive force use to collect the samples to move bodily fluid sample from the channels into the vessels.

Landscapes

• Chemical & Material Sciences (AREA)
• Health & Medical Sciences (AREA)
• Analytical Chemistry (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Physics & Mathematics (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biochemistry (AREA)
• General Physics & Mathematics (AREA)
• Immunology (AREA)
• Pathology (AREA)
• Investigating Or Analysing Biological Materials (AREA)

Applications Claiming Priority (3)

Publications (2)

Family

ID=58488662

Family Applications (1)

Country Status (2)

Families Citing this family (4)

Family Cites Families (9)

• 2016
  • 2016-10-07 EP EP16854509.3A patent/EP3359115A4/de not_active Withdrawn
  • 2016-10-07 WO PCT/US2016/056161 patent/WO2017062892A1/en active Application Filing

Also Published As

Similar Documents

Legal Events