Systems, devices, and methods for bodily fluid sample collection

• US 9,427,184 B2
• Filed: 06/30/2014
• Issued: 08/30/2016
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A., Chen, Michael, Ko, Pey-Jiun, Burd, Tammy, Lath, Adrit, McHale, Patricia
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): Leedy, Megan
• Application Number:
  US14/320,471
• Publication Number:
  US 20140316300A1
• Time in Patent Office: 792 Days
• Field of Search: 600/573, 600/575, 600/576, 604/410, 604/416
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150053 for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
• CPC Class Codes: A61B 5/150076 by heating
• 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 5/150213 Venting means
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15111 : 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 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15144 : comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61L 2300/42 : Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 33/0011 : Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate

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, the device comprising:

a first portion comprising at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing 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 containers for receiving the bodily fluid sample collected in the sample collection channels, the sample containers operably engagable to be in fluid communication with the collection channels, whereupon when fluid communication is established, the containers 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 containers.

2. The device of claim 1, wherein the first portion is formed from an optically transmissive material.

3. The device of claim 1, wherein the second portion contains an optical indicator that provides a visual indication of whether the sample has reached the sample container in the second portion.

4. The device of claim 1, wherein containers are arranged such that mixing of the fluid sample between the containers does not occur.

5. The device of claim 1 wherein the first type of motive force comprises capillary force.

6. The device of claim 1 further comprising at least one vent to allow for flow in said sample collection channels.

7. The device of claim 1, wherein the interior coating comprises ethylenediaminetetraacetic acid (EDTA) and the another interior coating is different from EDTA.

8. The device of claim 1, wherein the interior coating comprises citrate and the another interior coating is different from citrate.

9. The device of claim 1, wherein the interior coating comprises heparin and the another interior coating is different from heparin.

10. The device of claim 1 wherein the second motive force comprises vacuum force.

11. The device of claim 1 wherein the bodily fluid sample is capillary blood.

12. The device of claim 1 wherein the sample containers are integrated together by way of a common holder.

13. The device of claim 1 wherein the sample containers are integrally formed with one another.

14. The device of claim 1, wherein the bodily fluid sample comprises a capillary blood sample.

15. The device of claim 1 further comprising at least one adapter channel operably engagable to create fluid communication between one of the collection channels and one of the sample containers.

16. The device of claim 15, wherein said at least one adapter channel has an adapter channel cross-sectional area smaller than a sample collection channel cross-sectional area.

17. The device of claim 15, wherein the device is further configured to enable fluid flow through the adapter channel that mixes the bodily fluid sample with anticoagulant prior to the sample entering one of the sample containers and without repeatedly tilting or agitating the device.

18. The device of claim 15, wherein the adapter channel has a non-coring penetrating end.

19. The device of claim 1, wherein the at least two sample collection channels comprise molded channels formed in the first portion.

20. The device of claim 1 wherein at least one of the channels further comprises a hydrophobic coating.

21. The device of claim 1 wherein said channels are configured to receive the bodily fluid sample from an interface on the first portion, wherein the interface comprises a shaped front end configured to engage target tissue on the subject.

22. The device of claim 1 further comprising a lancet having an actuator to extend at least one portion of the lancet beyond a distal end of the first portion of the device.

23. The device of claim 22, wherein the actuator comprises a spring.

24. The device of claim 22, wherein the actuator comprises a spring-driven cam mechanism.

25. The device of claim 1, wherein at least one of the sample containers comprises a transparent material.

26. The device of claim 1, wherein at least one of the sample containers comprises a translucent material.

27. The device of claim 1, wherein at least one of the sample collection channels has a polygonal cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels.

28. The device of claim 1, wherein at least one of the sample collection channels has an elliptical cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels.

29. The device of claim 1, wherein at least one of the sample collection channels has a circular cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels.

30. The device of claim 1, wherein each of the sample containers further comprises a cap.

31. The device of claim 30, wherein at least a portion of the cap fits into a portion of one of the sample containers.

32. The device of claim 1, wherein the sample containers are discrete containers, each individually separable from the first portion.

33. The device of claim 1, wherein at least one of the sample containers has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of one of the sample containers.

34. The device of claim 33, wherein the movable plunger portion has a contact area comprising a material having a hardness greater than other material along a perimeter of the plunger.

35. The device of claim 1, wherein the device is further configured mix the bodily fluid sample with the interior coating prior to the sample entering one of the sample containers and doing so without having to repeatedly tilt or agitate the device.

36. A device for collecting a fluid sample from a subject, comprising:

(a) a body comprising a first collection channel and a second collection channel, the first collection channel comprising a first opening and a second opening, and being configured to capture sample formed on a surface of the subject by drawing 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 container, the sample container being engageable 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 container;

wherein the interior of the first collection channel is coated with a first anticoagulant different from a second anticoagulant of the second collection channel.

37. The device of claim 36, wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

38. The device of claim 36, wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate.

39. The device of claim 36, wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin.

40. The device of claim 39, wherein the base is a window that allows a user to see the container in the base.

41. The device of claim 36, wherein the body is formed from an optically transmissive material.

42. The device of claim 36, wherein the base contains an optical indicator that provides a visual indication of whether the sample has reached the sample container in the base.

43. The device of claim 36, wherein the at least two sample collection channels comprise molded channels formed in the body.

44. The device of claim 36, wherein the body comprises a first portion and a second portion which mate to define said at least two sample collection channels.

45. The device of claim 36 wherein at least one of the channels further comprises a hydrophobic coating.

46. The device of claim 36, wherein the sample container has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of the sample container.

47. The device of claim 46, wherein the movable plunger portion has a contact area comprising a material having a hardness greater than other material along a perimeter of the plunger.

48. The device of claim 36, wherein the device is further configured mix the bodily fluid sample with the first anticoagulant prior to the sample entering the sample container and doing so without having to repeatedly tilt or agitate the device.

49. The device of claim 36, wherein the device is further configured to enable fluid flow through the adaptor channel that mixes the bodily fluid sample with one of anticoagulants prior to the sample entering the sample container and without repeatedly tilting or agitating the device.