# US 10,371,606 B2 · Bodily fluid sample collection and transport > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,371,606 B2 - Document ID: US10371606B2 - Status: Granted - Kind: B2 - Application number: 15/290,248 - Filed: 2016-10-11 - Published: 2017-05-04 - Granted: 2019-08-06 - Earliest claimed: 2015-07-21 - Assignees: Theraos IP Company, LLC - Applicants: Theranos IP Company, LLC - Inventors: Elizabeth A. Holmes; Clarissa Lui; Michael Chen; Daniel Young - Web page: https://patentgrep.com/patent/US10371606B2 ## CPC - B01L 3/502: {with fluid transport, e.g. in multi-compartment structures} - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/15003: {for venous or arterial blood} - A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes} - A61B 5/150251: {Collection chamber divided into at least two compartments, e.g. for division of samples (injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755)} - A61B 5/150343: {Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045)} - A61B 5/150732: {Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube} - A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing} - A61B 5/150992: {Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves} - A61B 5/151: {Devices} specially adapted for taking samples of capillary blood, e.g. by lancets {, needles or blades} - A61B 5/15109: {Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin} - A61B 5/15111: {Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user} - A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button} - A61B 5/15186: {Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use} - A61B 5/154: {Devices} using pre-evacuated means - B01L 3/5025: {for parallel transport of multiple samples} - B01L 3/527: {for a plurality of reagents} - B01L 3/545: {for laboratory containers} - G01N 1/38: Diluting, dispersing or mixing samples - G01N 1/4077: {by other techniques involving separation of suspended solids} - G01N 33/491: {by separating the blood components (G01N15/05 takes precedence)} - A61B 5/150305: {Packages specially adapted for piercing devices or blood sampling devices} - A61B 5/150351: {Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel} - A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin} - A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61B 5/150572: {Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes} - A61B 5/150793: {Electrical or magnetic identification means} - A61B 5/150824: {by visual feedback} - A61B 5/150954: {Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor} - A61B 5/150984: {Microneedles or microblades} - A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap} - B01L 2200/185: Long distance transport, e.g. mailing - B01L 2300/022: Transponder chips - B01L 2300/044: pierceable, e.g. films, membranes - B01L 2300/0672: Integrated piercing tool - B01L 2300/0832: cylindrical, tube shaped - B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting - B01L 2300/0877: Flow chambers - B01L 2300/18: Means for temperature control - B01L 2300/1822: using Peltier elements - B01L 2400/0409: centrifugal forces - G01N 2001/005: {Packages for mailing or similar transport of samples} - G01N 2001/4083: {sedimentation} - G01N 2035/00326: {Analysers with modular structure} - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device. ## Claims ### Claim 1 A device comprising: a channel comprising an anticoagulant coating; and a vessel configured to be in fluid communication with the channel, wherein the device is configured to: receive, in the channel, a bodily fluid sample provided by a subject; mix, in the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and collect, in the vessel, the mixed bodily fluid sample, wherein the anticoagulant coating comprises EDTA, and wherein the mixed bodily fluid sample comprises a bulk concentration of EDTA no less than about 2.5 milligrams per milliliter and no greater than about 10 milligrams per milliliter; wherein a concentration of the anticoagulant coating varies along a length of the channel according to a gradient. ### Claim 2 (depends on 1) The device of claim 1, wherein the bulk concentration of EDTA is no less than about 3 milligrams per milliliter and no greater than about 4 milligrams per milliliter. ### Claim 3 (depends on 1) The device of claim 1, wherein the device is further configured to mix the bodily fluid sample with the anticoagulant without generating a local concentration of EDTA greater than about 20 milligrams per milliliter. ### Claim 4 (depends on 1) The device of claim 1, wherein the device is further configured to mix the bodily fluid sample with the anticoagulant with a shear rate no greater than about 1,000 reciprocal seconds. ### Claim 5 (depends on 1) The device of claim 1, wherein the channel comprises a hydraulic diameter no less than about 0.5 millimeters and no greater than about 10 millimeters. ### Claim 6 (depends on 1) The device of claim 1, wherein the channel comprises a mixing element, and wherein the device is further configured to mix, in the channel, the bodily fluid sample with the anticoagulant coating based on an advection. ### Claim 7 (depends on 6) The device of claim 6, wherein the mixing element comprises a protrusion on a surface of the channel. ### Claim 8 (depends on 6) The device of claim 6, wherein the mixing element comprises a staggered herringbone structure on a surface of the channel. ### Claim 9 (depends on 1) The device of claim 1, wherein a magnitude of the gradient of the anticoagulant concentration decreases as the distance from an open end of the channel increases. ### Claim 10 A device comprising: a channel comprising an anticoagulant coating; and a vessel configured to be in fluid communication with the channel, wherein the device is configured to: receive, in the channel, a bodily fluid sample provided by a subject; mix, In the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and collect, in the vessel, the mixed bodily fluid sample, wherein the anticoagulant coating comprises EDTA, and wherein the mixed bodily fluid sample comprises a bulk concentration of EDTA no less than about 2.5 milligrams per milliliter and no greater than about 10 milligrams per milliliter, wherein a thickness of the anticoagulant coating varies along a length of the channel according to a gradient. ### Claim 11 (depends on 10) The device of claim 10, wherein a magnitude of the gradient of the anticoagulant thickness decreases as the distance from an open end of the channel increases. ### Claim 12 A device comprising: a channel comprising an anticoagulant coating; and a vessel configured to be in fluid communication with the channel, wherein the device is configured to: receive, in the channel, a bodily fluid sample provided by a subject; mix, in the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and collect, in the vessel, the mixed bodily fluid sample wherein the anticoagulant coating comprises heparin, and wherein the mixed bodily fluid sample comprises a bulk concentration of heparin no less than about 20 units per milliliter and no greater than about 150 units per milliliter wherein a thickness of the anticoagulant coating varies along a length of the channel according to a gradient. ### Claim 13 (depends on 12) The device of claim 12, wherein the device is further configured to mix the bodily fluid sample with the anticoagulant with a shear rate no greater than about 1,000 reciprocal seconds. ### Claim 14 (depends on 12) The device of claim 12, wherein the channel comprises a hydraulic diameter no less than about 0.5 millimeters and no greater than about 10 millimeters. ### Claim 15 (depends on 12) The device of claim 12, wherein the channel comprises a mixing element, and wherein the device is further configured to mix, in the channel, the bodily fluid sample with the anticoagulant coating based on an advection. ### Claim 16 (depends on 15) The device of claim 15, wherein the mixing element comprises a protrusion on a surface of the channel. ### Claim 17 (depends on 15) The device of claim 15, wherein the mixing element comprises a staggered herringbone structure on a surface of the channel. ### Claim 18 (depends on 12) The device of claim 12, wherein a magnitude of the gradient of the anticoagulant thickness decreases as the distance from an open end of the channel increases.