Systems, devices, and methods for bodily fluid sample collection

• US 9,636,062 B2
• Filed: 03/15/2014
• Issued: 05/02/2017
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A., Chen, Michael, Ko, Pey-Jiun, Burd, Tammy, Lath, Adrit, McHale, Patricia
• Primary Examiner(s): Eiseman, Adam J
• Assistant Examiner(s): Fernandez, Patrick
• Application Number:
  US14/214,774
• Publication Number:
  US 20140323913A1
• Time in Patent Office: 1,144 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150343 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 5/150824 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 5/15109 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 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2400/0406 : capillary 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 3/563 : Joints or fittings in general F16L; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors

Abstract

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

Claims

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

a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to draw the fluid sample into each of the at least two sample collection channels via a first type of motive force, wherein the first portion defines a blunt, non-tissue penetrating distal end configured for collecting sample from an outer surface of the subject;

a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, whereupon when the sample containers are operably engaged from a first condition to a second condition, the containers provide a second motive force different from the first motive force to move bodily fluid sample along at least one fluid pathway from the first portion into the containers of the second portion;

wherein the sample collection channels each have a longitudinal dimension greater than a sample container longitudinal dimension of each of the sample containers, such that each of the sample collection channels holds at least a predetermined amount sample for that channel and substantially all of said predetermined amount is transferred via the second motive force into an associated one of the sample containers;

a body portion coupling the first portion with the second portion,

a base coupled to the body portion, wherein the base comprises an optical indicator that provides a visual indication of whether the sample has reached the sample container in the base; and

a slide interface between the base holding the sample containers and the body portion.

2. The device of claim 1 wherein an interior of each of the collection channels is coated with at least one anticoagulant.

3. The device of claim 2 wherein an interior of a first of the collection channels is coated with a first anticoagulant different from a second anticoagulant coating an interior of a second of the collection channels.

4. The device of claim 3, wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

5. The device of claim 4, wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate.

6. The device of claim 4, wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin.

7. The device of claim 1 wherein the number of sample containers is the same as the number of collection channels.

8. The device of claim 1, wherein the base has a window that allows a user to see the container in the base portion.

9. The device of claim 1, wherein the second opening of the collection channel or the adaptor channel is capped by a sleeve, wherein said sleeve does not prevent movement of bodily fluid via capillary action from the first opening towards the second opening.

10. The device of claim 1, wherein each collection channel can hold a volume no greater than about 200 uL.

11. The device of claim 1, wherein each collection channel can hold a volume no greater than about 100 uL.

12. The device of claim 2, wherein an opening of the first of the collection channels is adjacent to an opening of said second of the collection channels, and the openings are configured to draw blood simultaneously from the fluid sample.

13. The device of claim 12, wherein the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm.

14. The device of claim 1, wherein each sample container has an interior volume no greater than two times larger than the interior volume of the collection channel with which it is engagable.

15. The device of claim 1, wherein establishment of fluidic communication between the collection channel and the sample container results in transfer of at least 90% of the bodily fluid sample in the collection channels into the sample containers.

16. The device of claim 1, wherein the sample container provides a motive force different from capillary action to move fluid sample into the sample container when the sample container is in fluid communication with the collection channel.

17. The device of claim 1 further comprising a fluid flow mechanism that provides a motive force different from capillary action to move fluid sample from the collection channel into the sample container when the sample container is in fluid communication with the collection channel.