Sampling assembly

• US 10,881,342 B2
• Filed: 02/14/2014
• Issued: 01/05/2021
• 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
• Primary Examiner(s): Towa, Rene T
• Application Number:
  US14/180,751
• Publication Number:
  US 20140236044A1
• Time in Patent Office: 2,517 Days
• 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. A single use assembly for sampling bodily fluid, the assembly comprising a membrane penetrating element for penetrating a bodily membrane to release a supply of bodily fluid;

an engagement arm; and

a collector reservoir positioned on the engagement arm, the membrane penetrating element being positioned separate from and outside of the collector reservoir and the engagement arm, the collector reservoir being configured to adopt a collection position to take up and store a sample of released bodily fluid from the supply of bodily fluid in the collector reservoir and a delivery position to deliver the stored sample from the collector reservoir to a test element, the collector reservoir having a predefined sample volume, wherein the collector reservoir is not in fluid communication with the test element in the collection position and is not in fluid communication with the supply of bodily fluid in the delivery position;

wherein the collector reservoir is configured to move between the collection position and the delivery position by movement of the engagement arm; and

wherein the assembly is configured such that movement of the collector reservoir between the collection position and the delivery position is controlled bar movement of the engagement arm.

2. The assembly according to claim 1, wherein the collector reservoir is configured to take up the sample of released bodily fluid by capillary action.

3. The assembly according to claim 1, wherein the collector reservoir comprises a tube including a ventilation aperture.

4. The assembly according to claim 3, wherein the tube includes a collection opening and a discharge opening, and the ventilation aperture is a longitudinal slot extending from the collection opening to the discharge opening.

5. The assembly according to claim 1, wherein the collector reservoir is adapted in the delivery position to deliver the sample to a specific, predefined position on the test element.

6. The assembly according claim 1, wherein the collector reservoir is operatively adapted to move from the collection position to the delivery position by one or more of pivoting, sliding, rotating and translating of the engagement arm.

7. The assembly according to claim 1 wherein the collector reservoir is inhibited from moving into the delivery position by a locking mechanism until after the membrane penetrating element has been actuated.

8. The assembly according to claim 1, further including a retainer adapted to retain the collector reservoir.

9. The assembly according to claim 8, wherein the retainer is selected from the group consisting of a clip engaged with the assembly, a pivotable engagement, and a cavity.

10. The assembly according to claim 1, wherein the assembly further includes an internal storage for a solution and an actuator adapted to release the solution from the internal storage to the test element.