Integrated testing device

• US 10,525,463 B2
• Filed: 03/29/2016
• Issued: 01/07/2020
• Est. Priority Date: 03/19/2010
• Status: Active Grant

• Current Assignee: Atomo Diagnostics Pty Limited
• Original Assignee: Atomo Diagnostics Pty Limited
• Inventors: Kelly, John Michael, Siu, Eric, Norcott, Alison Ruth, Dunn, Christopher David, Johnson, Ian Frederick, Hueso, Ernesto Monis, Sokolov, Richard
• Primary Examiner(s): Merkling, Sally A
• Application Number:
  US15/083,839
• Publication Number:
  US 20170001192A1
• Time in Patent Office: 1,379 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150358 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 5/150503 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 5/150549 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 5/150717 manually removed
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/15192 : comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/0605 : Metering of fluids
• CPC Class Codes: B01L 2200/16 : Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/14 : Means for pressure control
• CPC Class Codes: B01L 2400/0475 : specific mechanical means and fluid pressure
• 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 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis

Abstract

An integrated testing device and method are disclosed. The device includes an integral reservoir for a test fluid, and an actuator, so that the test fluid can be dispensed to facilitate the test.

Claims

1. A disposable composite diagnostic system comprising:

a support member having at least one housing surface separating an exterior visible from outside the support member and an interior within the support member;

a membrane penetration element;

a test material positioned within the interior of the support member;

a capillary tube extending from an opening outside the support member through the housing surface to an outlet within the interior for discharge onto the test material;

such that operatively the capillary tube is adapted to take up a bodily fluid after it is released by application of the membrane penetration element and conduct the bodily fluid into contact with the test material;

an internal reservoir located within the interior of the support member and adapted to contain a physiologically acceptable solution; and

a solution delivery actuator, the arrangement being such that, actuation of the solution delivery actuator causes the physiologically acceptable solution to be released from the reservoir so that it is brought into contact with the test material after the bodily fluid has contacted the test material.

2. A composite diagnostic system according to claim 1, wherein the solution delivery actuator is adapted to be manually operated.

3. A composite diagnostic system according to claim 1, wherein the solution delivery actuator is operated automatically during use of the system.

4. A composite diagnostic system according to claim 1, wherein the physiologically acceptable solution is a buffer.

5. A composite diagnostic system according to claim 1, wherein the system is adapted to release a controlled amount of fluid by one of displacement, pressure, differential, or capillary forces.

6. A composite diagnostic system according to claim 1, wherein the test material is removable from the support member.

7. A composite diagnostic system as defined in claim 1, wherein the membrane penetration element comprises a lancet.

8. A composite diagnostic system as defined in claim 1, wherein the membrane penetration element comprises a lancing system comprising a lancet tip, the lancet being moveable between a rest position in which the lancet tip is situated within the support member and an actuated position in which the lancet tip extends beyond the exterior of the support member.

9. A composite diagnostic system according to claim 1, wherein the reservoir comprises a sachet containing the physiologically acceptable solution.

10. A composite diagnostic system according to claim 1, further comprising an interface element adapted to allow the system to interface with diagnostic equipment.

11. A composite diagnostic system as defined in claim 10, wherein the interface element is removable and can then engage with diagnostic equipment.