SAMPLING ASSEMBLY

• US 20140236044A1
• Filed: 02/14/2014
• Published: 08/21/2014
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Atomo Diagnostics Pty Limited
• Original Assignee: Atomo Diagnostics Pty Limited
• Inventors: KELLY, John, SOKOLOV, Richard, JOHNSON, Ian Fredrick, HUESO, Ernesto Monis, SIU, Eric, SHIUE, Melody, LAW, Kamman, BEHRISCH, Johannes
• Granted Patent: US 10,881,342 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150419 comprising means for capillary action
• 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 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An assembly for sampling bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and retain the fluid for delivery to a test element.

Claims

1. An assembly for sampling bodily fluid, the assembly including a collector having a first position in which it is configured to receive a bodily fluid and retain a sample of the bodily fluid in the collector for delivery, the collector being movable relative to said assembly into a second position to deliver the sample to a test element.

2. An assembly according to claim 1, wherein the collector is adapted to retain a specific sample volume.

3. An assembly according to claim 2, wherein the collector will only accept the specific sample volume in said first position, and is adapted to deliver the specific sample volume to said test element in said second position.

4. An assembly according to claim 1, wherein the collector is adapted, in said second position, to deliver said sample to a specific point on said test element.

5. An assembly according to claim 4, wherein said test element includes a first location for deposit of said sample, and a second location at which a test result is indicated, said collector being adapted in said second position to deliver said sample to said first location.

6. An assembly according to claim 1, wherein the collector is configured to draw up the sample from a released bodily fluid by capillary action.

7. An assembly according to claim 1, wherein the collector includes a vent opening.

8. An assembly according to claim 1, wherein the collector includes a generally tubular body with as opening at either end, and a longitudinal slot extending between the openings and through the tubular body.

9. An assembly according to claim 1, wherein the collector is generally tubular and extends between an collection opening and a release opening, and is tapered toward the collection opening.

10. An assembly according to claim 7, wherein the internal surface of the collector is raked toward the opening.

11. An assembly according to claim 1, wherein the collector is operatively adapted to move from said first position to said second position by one or more of pivoting, sliding, rotating or translating.

12. An assembly according to claim 1, wherein the assembly further includes a penetration device for operatively penetrating a bodily membrane to release the bodily fluid, and wherein the collector is inhibited from moving into the second position until after the penetration device has been actuated.

13. An assembly according to claim 1, wherein the collector comprises at least, one collection opening for uptake of the released fluid, the assembly further comprising a cover configured to cover the collection opening.

14. An assembly according to claim 13, wherein the cover blocks the collection opening in the second position.

15. An assembly according to claim 1, wherein the rate of movement of the collector between the first position and the second position is controlled.

16. An assembly according to claim 7, wherein the vent opening is independent from the collect ion opening.

17. An assembly according to claim 1, further including a retainer adapted to retain the collector.

18. An assembly according to claim 17, wherein the retainer is selected from the group comprising a clip engaged with the assembly, a pivotable engagement, and a cavity.

21. An assembly according to claim 7, wherein the vent opening comprises a slot extending longitudinally at least part of the length of the collector.

19. A method for testing a sample of bodily fluid, including the steps of:

Providing a testing assembling, including at least a collector, and a test element;

Causing a bodily fluid to be released;

With said collector in a first position, receiving a sample of said bodily fluid into said collector;

Moving said collector to a second position, so that said collector is positioned to transfer the sample to said test element.

20. A method according to claim 19, wherein the collector retains only a specific sample volume, and transfer the specific sample volume to said test element.