Bodily fluid sample collection and transport

• US 10,371,606 B2
• Filed: 10/11/2016
• Issued: 08/06/2019
• Est. Priority Date: 07/21/2015
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: The Theraos IP Company LLC
• Inventors: Holmes, Elizabeth A., Lui, Clarissa, Chen, Michael, Young, Daniel
• Primary Examiner(s): White, Dennis
• Application Number:
  US15/290,248
• Publication Number:
  US 20170122846A1
• Time in Patent Office: 1,029 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: 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
• CPC Class Codes: 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 caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: 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,
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: 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, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: B01L 2200/185 : Long distance transport, e.g. mailing
• CPC Class Codes: B01L 2300/022 : Transponder chips
• CPC Class Codes: B01L 2300/044 : pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2300/0832 : cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 2300/1822 : using Peltier elements
• CPC Class Codes: B01L 2400/0409 : centrifugal forces
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5025 : for parallel transport of multiple samples
• CPC Class Codes: B01L 3/527 : for a plurality of reagents
• CPC Class Codes: B01L 3/545 : for laboratory containers
• CPC Class Codes: G01N 1/38 : Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 1/4077 : by other techniques involving separation of suspended solids
• CPC Class Codes: G01N 2001/005 : Packages for mailing or similar transport of samples
• CPC Class Codes: G01N 2001/4083 : sedimentation
• CPC Class Codes: G01N 2035/00326 : Analysers with modular structure
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The device of claim 6, wherein the mixing element comprises a protrusion on a surface of the channel.

8. The device of claim 6, wherein the mixing element comprises a staggered herringbone structure on a surface of the channel.

9. 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.

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.

11. 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.

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.

13. 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.

14. 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.

15. 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.

16. The device of claim 15, wherein the mixing element comprises a protrusion on a surface of the channel.

17. The device of claim 15, wherein the mixing element comprises a staggered herringbone structure on a surface of the channel.

18. 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.