INTEGRATED TESTING DEVICE

• US 20130323123A1
• Filed: 03/15/2013
• Published: 12/05/2013
• 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
• Granted Patent: US 9,295,987 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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. An integrated testing device comprising:

a test component;

a reservoir adapted to contain a test fluid; and

a fluid delivery actuator, wherein operation of the fluid delivery actuator causes the test fluid to be released from the reservoir so as to contact the test component.

2. An integrated testing device according to claim 1, wherein the device further includes a receptacle for receiving a bodily fluid, so that the bodily fluid contacts or can be caused to contact the test component.

3. An integrated testing device according to claim 2, wherein the actuator is adapted to be manually operated.

4. An integrated testing device according to claim 1, wherein an interlock prevents the release of the test fluid until a specific stage in the test process.

5. An integrated testing device according to claim 4, wherein an interlock prevents the release of the test fluid until the bodily fluid has contacted the test component.

6. An integrated testing device according to claim 1, wherein the test component is removable from the diagnostic system.

7. An integrated testing device according to claim 1, wherein the actuator is adapted to enable the release a controlled amount of test fluid.

8. An integrated testing device according to claim 1, wherein the device comprises a plurality of reservoirs adapted to contain test fluids.

9. An integrated testing device according to claim 1, wherein the or each reservoir is a separately formed sachet.

10. An integrated testing device according to claim 9, wherein the sachet is formed so that when pressure is applied by the actuator, test fluid is emitted from a specific site on the sachet.

11. Am integrated testing device according to claim 10, wherein the actuator comprises a button located on the housing of the device.

12. An integrated testing device, comprising a support structure, a reservoir adapted to contain a test fluid, and a fluid delivery actuator, the device being adapted to receive a test component in said support structure, so that operatively, once a test component is received, the fluid delivery actuator can selectively causes the test fluid to be released from the reservoir so as to contact the test component.

13. An integrated testing device according to claim 12, wherein the reservoir is a separately formed sachet, and contains a test fluid appropriate from the test component.

14. An integrated testing device according to claim 14, wherein the sachet is formed so that when pressure is applied by the fluid delivery actuator, the test fluid is emitted from a specific site on the sachet.

15. A method for conducting a test on a sample of a bodily fluid, comprising the steps of providing a testing device including a reservoir containing a test fluid, and further including a test component, wherein a sample of the bodily fluid is placed on the test component, and a quantity of test fluid is discharged from said reservoir onto the test component, the discharge being either before or after the sample is placed on the test component, so that the test component can thereby conduct the test.