Devices, systems, and methods for sample collection

• US 10,638,963 B2
• Filed: 08/17/2018
• Issued: 05/05/2020
• Est. Priority Date: 01/10/2017
• Status: Active Grant

• Current Assignee: Drawbridge Health, Inc. (Thorne HealthTech, Inc.)
• Original Assignee: Drawbridge Health, Inc. (Thorne HealthTech, Inc.)
• Inventors: Beyerlein, Dagmar, Drexel, Masao, Jordan, Brett L., Jackson, Alicia, Juneau, Kara
• Primary Examiner(s): Dougherty, Sean P
• Application Number:
  US16/104,846
• Publication Number:
  US 20190000365A1
• Time in Patent Office: 627 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting 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 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/18 Transport of container or devices
• CPC Class Codes: B01L 2300/021 : Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/041 : Connecting closures to device or container
• CPC Class Codes: B01L 2300/06 : Auxiliary integrated devices, integrated components
• CPC Class Codes: B01L 2300/0609 : Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0825 : Test strips
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 3/0296 : from piercable tubing, e.g. in extracorporeal blood sampling
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/508 : rigid containers not provided for above
• CPC Class Codes: G01N 33/487 : of liquid biological material
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G01N 35/00732 : Identification of carriers, materials or components in automatic analysers

Abstract

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

Claims

1. A device for collecting and storing blood from a subject, the device comprising:

a housing comprising a recess having an opening;

a vacuum chamber in the housing, the vacuum chamber having an initial state of a vacuum and configured such that activation of the vacuum causes fluidic communication to be established between the vacuum chamber and the recess to draw skin of the subject into the recess, and the recess serves as a suction cavity for drawing the skin, wherein a volume of the skin enclosed by the recess under vacuum ranges from about 0.4 cm³ to about 4.0 cm³, and a surface area of the skin in contact with the recess ranges from about 3.2 cm² to about 7.2 cm², the recess comprising a size or shape configured to enable an increased volume of the blood to be collected under increased capillary pressure differential, the increased volume of the blood being dependent on a volume and/or surface area of the skin that is drawn into the recess;

one or more piercing elements that are extendable through the opening to penetrate the skin of the subject to enable collection of the blood while the skin is drawn into the recess;

a cartridge chamber configured to receive a cartridge that is configured to hold one or more matrices for collecting and storing the blood; and

the cartridge releasably coupled via a cartridge port to an output port in the cartridge chamber.

2. The device of claim 1, wherein the initial state of the vacuum in the vacuum chamber comprises a pressure ranging from about −

4 psig to about −

15 psig.

3. The device of claim 1, wherein the device is configured to draw and collect the blood from the subject at an average flowrate of at least 30 μ

L/min after penetration by the one or more piercing elements.

4. The device of claim 1, wherein the device is configured to draw and collect the blood at an average flowrate of at least 150 μ

L/min, and to maintain the average flowrate until at least 150-300 μ

L of the blood has been collected.

5. The device of claim 1, wherein upon activation of the vacuum from the vacuum chamber, (1) a pressure of the vacuum and (2) the recess comprising the size or shape are configured to permit the skin to substantially conform to the recess, such that a surface of the recess is substantially in contact with the skin drawn into the recess.

6. The device of claim 1, wherein a surface area of the recess is at least ten times greater than an area of the opening.

7. The device of claim 6, wherein the surface area of the recess ranges from about 75 mm² to about 2900 mm², and the area of the opening ranges from about 1.5 mm² to about 30 mm².

8. The device of claim 1, wherein an area of the skin directly under the opening is at least 1.5 times smaller than a total area of the skin drawn into the recess.

9. The device of claim 8, wherein the area of the skin directly under the opening is at least 5 times smaller than the total area of the skin drawn into the recess.

10. The device of claim 1, wherein the recess comprises a concave cavity comprising a volume ranging from about 1.0 cm³ to about 5.0 cm³.

11. The device of claim 1, wherein the recess is in the shape of a spherical cap comprising a base diameter ranging from about 10 mm to about 60 mm and a height ranging from about 3 mm to about 30 mm.

12. The device of claim 11, wherein the opening is at an apex of the spherical cap.

13. The device of claim 1, wherein the recess comprises one or more fillets configured to improve vacuum suction to the skin and reduce vacuum leak.

14. The device of claim 13, wherein the one or more fillets extend continuously along a periphery of the recess.

15. The device of claim 13, wherein the one or more fillets are in contact with the skin when the skin is drawn into the recess.

16. The device of claim 1, wherein the skin is drawn into the recess by the vacuum and completely fills the recess in less than 1 second.

17. The device of claim 1, wherein the device is supported and held in place on the skin of the subject with aid of an adhesive and the vacuum.

18. The device of claim 1, wherein the device is configured to collect the blood at a rate that is dependent on (a) the size or shape of the recess and/or (b) vacuum pressure.

19. The device of claim 1, wherein the device is capable of collecting 175 μ

L to 300 μ

L of blood from the subject in less than 3 minutes.

20. The device of claim 1, wherein the device is configured for use on an upper portion of an arm of the subject in a position or orientation that enhances the collection of the blood with aid of gravity.

21. The device of claim 1, wherein the vacuum chamber is not in fluidic communication with the recess prior to the activation of the vacuum.

22. The device of claim 1, wherein the vacuum is activated by breaking a barrier provided on a wall of the vacuum chamber, and wherein the fluidic communication between the vacuum chamber and the recess is established when the barrier is broken.

23. The device of claim 1, wherein the vacuum chamber comprises a septum through which air is drawn out of the vacuum chamber to provide the initial state of vacuum.

24. The device of claim 23, wherein the septum comprises an airtight flexible material.

25. The device of claim 1, wherein the housing comprises the cartridge chamber.

26. The device of claim 1, wherein the cartridge is releasably coupled to the cartridge chamber via a quick release mechanism.

27. The device of claim 1, wherein a seal seals the cartridge when the cartridge is received in the cartridge chamber.

28. The device of claim 1, wherein the cartridge comprises the one or more matrices for collecting and storing the blood.

29. The device of claim 1, wherein the cartridge comprises two or more matrices for collecting and storing the blood.

30. The device of claim 1, wherein the cartridge has two matrices for collecting and storing the blood.

31. The device of claim 29, wherein the two or more matrices are disposed in a configuration that permits the blood to wick between and along the two or more matrices.

32. The device of claim 29, wherein the two or more matrices are disposed substantially parallel to each other.

33. The device of claim 29, wherein the two or more matrices are separated by a gap.

34. The device of claim 33, wherein the gap is about 0.5 mm.

35. The device of claim 29, wherein each of the two or more matrices is capable of collecting at least 60 μ

L of blood.

36. The device of claim 29, wherein the cartridge comprises a spacer disposed between a portion of each of the two or more matrices.

37. The device of claim 29, wherein the two or more matrices are separated by two or more spacers.

38. The device of claim 37, wherein the two or more spacers are placed between the two or more matrices to form a channel through which blood can flow via capillary action and wicking.

39. The device of claim 28, wherein the cartridge comprises one or more absorbent pads configured to be in fluidic communication with the one or more matrices, wherein the one or more absorbent pads are configured to hold excess blood.

40. The device of claim 29, wherein each of the two or more matrices is configured to hold and maintain about 75 μ

L of blood.

41. The device of claim 29, wherein the cartridge comprises one or more absorbent pads configured to be in fluidic communication with the two or more matrices, wherein the one or more absorbent pads are configured to hold at least 100 μ

L of excess blood.

42. The device of claim 1, wherein the cartridge comprises a cartridge tab configured to be used by a subject or a user to insert the cartridge in the cartridge chamber or remove the cartridge from the cartridge chamber.

43. The device of claim 1, wherein the one or more matrices comprise paper.

44. The device of claim 43, wherein the paper comprises cellulose.

45. The device of claim 1, further comprising a window configured to enable a subject or user to monitor a progress of blood collection as the blood flows into and is collected in the cartridge.

46. The device of claim 45, wherein the housing comprises the cartridge chamber configured to receive the cartridge, wherein the window is parallel to a longitudinal axis of the cartridge chamber.

47. A device for collecting and storing blood from a subject, the device comprising:

a housing comprising a recess having an opening;

a vacuum chamber in the housing, the vacuum chamber having an initial state of a vacuum and configured such that activation of the vacuum causes fluidic communication to be established between the vacuum chamber and the recess to draw skin of the subject into the recess, and the recess serves as a suction cavity for drawing the skin, wherein a volume of the skin enclosed by the recess under vacuum ranges from about 0.4 cm³ to about 4.0 cm³, and a surface area of the skin in contact with the recess ranges from about 3.2 cm² to about 7.2 cm², the recess comprising a size or shape configured to enable an increased volume of the blood to be collected under increased capillary pressure differential, the increased volume of the blood being dependent on a volume and/or surface area of the skin that is drawn into the recess;

one or more piercing elements that are extendable through the opening to penetrate the skin of the subject to enable collection of the blood while the skin is drawn into the recess;

a cartridge chamber in the housing configured to receive a cartridge;

a cartridge comprising a cartridge port releasably coupled to the cartridge chamber, two paper matrices disposed substantially parallel to each other for collecting and storing the blood and separated by one or more spacers to form a channel through which the blood can flow via capillary action and wicking, one or more absorbent pads configured to be in fluidic communication with the one or more matrices and configured to hold excess blood, and a cartridge tab configured to be used by a subject or a user to insert the cartridge in the cartridge chamber or remove the cartridge from the cartridge chamber;

a seal that seals the cartridge when the cartridge is in the cartridge chamber; and

a window configured to enable a subject or user to monitor a progress of blood collection as the blood flows into and is collected in the cartridge, wherein the window is parallel to a longitudinal axis of the cartridge chamber.

48. The device of claim 47, wherein the initial state of the vacuum in the vacuum chamber comprises a pressure ranging from about −

4 psig to about −

15 psig.

49. The device of claim 47, wherein the device is configured to draw and collect the blood from the subject at an average flowrate of at least 30 μ

L/min after penetration by the one or more piercing elements.

50. The device of claim 47, wherein the device is configured to draw and collect the blood at an average flowrate of at least 150 μ

L/min, and to maintain the average flowrate until at least 150-300 μ

L of the blood has been collected.

51. The device of claim 47, wherein upon activation of the vacuum from the vacuum chamber, (1) a pressure of the vacuum and (2) the recess comprising the size or shape are configured to permit the skin to substantially conform to the recess, such that a surface of the recess is substantially in contact with the skin drawn into the recess.

52. The device of claim 47, wherein a surface area of the recess is at least ten times greater than an area of the opening.

53. The device of claim 52, wherein the surface area of the recess ranges from about 75 mm² to about 2900 mm², and the area of the opening ranges from about 1.5 mm² to about 30 mm².

54. The device of claim 47, wherein an area of the skin directly under the opening is at least 1.5 times smaller than a total area of the skin drawn into the recess.

55. The device of claim 54, wherein the area of the skin directly under the opening is at least 5 times smaller than the total area of the skin drawn into the recess.

56. The device of claim 47, wherein the recess comprises a concave cavity comprising a volume ranging from about 1.0 cm³ to about 5.0 cm³.

57. The device of claim 47, wherein the recess is in the shape of a spherical cap comprising a base diameter ranging from about 10 mm to about 60 mm and a height ranging from about 3 mm to about 30 mm.

58. The device of claim 57, wherein the opening is at an apex of the spherical cap.

59. The device of claim 47, wherein the recess comprises one or more fillets configured to improve vacuum suction to the skin and reduce vacuum leak.

60. The device of claim 59, wherein the one or more fillets extend continuously along a periphery of the recess.

61. The device of claim 59, wherein the one or more fillets are in contact with the skin when the skin is drawn into the recess.

62. The device of claim 47, wherein the skin is drawn into the recess by the vacuum and completely fills the recess in less than 1 second.

63. The device of claim 47, wherein the device is supported and held in place on the skin of the subject with aid of an adhesive and the vacuum.

64. The device of claim 47, wherein the device is configured to collect the blood at a rate that is dependent on (a) the size or shape of the recess and/or (b) vacuum pressure.

65. The device of claim 47, wherein the device is capable of collecting 175 μ

L to 300 μ

L of blood from the subject in less than 3 minutes.

66. The device of claim 47, wherein the device is configured for use on an upper portion of an arm of the subject in a position or orientation that enhances the collection of the blood with aid of gravity.

67. The device of claim 47, wherein the vacuum chamber is not in fluidic communication with the recess prior to the activation of the vacuum.

68. The device of claim 47, wherein the vacuum is activated by breaking a barrier provided on a wall of the vacuum chamber, and wherein the fluidic communication between the vacuum chamber and the recess is established when the barrier is broken.

69. The device of claim 47, wherein the vacuum chamber comprises a septum through which air is drawn out of the vacuum chamber to provide the initial state of vacuum.

70. The device of claim 69, wherein the septum comprises an airtight flexible material.

71. The device of claim 47, wherein the cartridge is releasably coupled to the cartridge chamber via a quick release mechanism.

72. The device of claim 47, wherein a seal seals the cartridge when the cartridge is received in the cartridge chamber.

73. The device of claim 47, wherein the two paper matrices are separated by a gap using the one or more spacers.

74. The device of claim 73, wherein the gap is about 0.5 mm.

75. The device of claim 47, wherein each of the two paper matrices is capable of collecting at least 60 μ

L of blood.

76. The device of claim 47, wherein each of the two paper matrices is configured to hold and maintain about 75 μ

L of blood.

77. The device of claim 47, wherein the one or more absorbent pads are configured to hold at least 100 μ

L of the excess blood.

78. The device of claim 47, wherein the two paper matrices comprise cellulose.