Integrated testing device

• US 9,295,987 B2
• Filed: 03/15/2013
• Issued: 03/29/2016
• 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 ANNE
• Application Number:
  US13/838,145
• Publication Number:
  US 20130323123A1
• Time in Patent Office: 1,110 Days
• Field of Search: 600/573
• US Class Current: 1/1
• 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 support housing defining an interior surrounded at least partially by the housing and defining an exterior on an opposite side of the housing from the interior;

a bodily fluid collection element positioned so as to be visible from outside the support housing and movably mounted to the support housing for movement between a collection position in which the collection element is separated from the interior of the housing and a delivery position in which the collection element extends to the interior and defines a bodily fluid path that extends through the housing from the exterior to the interior, whereby the collection and deposit of bodily fluid at the bodily fluid collection element can be visually observed;

a test component positioned within the interior in fluid communication with the bodily fluid path to receive a bodily fluid from the bodily fluid collection element in the delivery position;

an internal reservoir containing a test fluid and positioned within the interior to supply the test fluid to the test component;

a fluid delivery actuator moveable between a rest position and an actuation position to effect the release of the test fluid from the internal reservoir for delivery to the test component; and

an interlock moveable between a lock position blocking movement of the fluid delivery actuator to the actuation position and a release position allowing movement of the fluid delivery actuator to the actuation position, the fluid collection element moving the interlock from the lock position to the actuation position as the fluid collection element moves to the delivery position.

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

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

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

5. An integrated testing device according to claim 1, wherein the internal reservoir is a separately formed sachet.

6. An integrated testing device according to claim 5, wherein the sachet is formed and constructed so that when pressure is operatively applied by the actuator, test fluid is emitted from a specific site on the sachet.

7. An integrated testing device according to claim 6, wherein the actuator comprises a button located on the housing of the device.

8. An integrated testing device according to claim 4, wherein each internal reservoir is a separately formed sachet.

9. An integrated testing device according to claim 1, wherein the actuator is operatively adapted to be manually operated.

10. A composite diagnostic system according to claim 1, wherein the bodily fluid collection element includes a fluid collection tube for collecting and holding a predetermined amount of bodily fluid in the collection position and delivering the predetermined amount of bodily fluid to the test material in the delivery position.

11. A composite diagnostic system according to claim 10, wherein the fluid collection tube includes a capillary.

12. A composite diagnostic system according to claim 10, wherein the fluid collection tube is pivotally mounted to the support housing by an arm to swing between the collection position in which the tube is suspended away from the support housing to the delivery position in which the tube extends through an opening in the housing to contact the test component.

13. A composite diagnostic system according to claim 1, further comprising an integrated membrane penetrating element moveable between a retracted position within the support housing and an extended position in which the membrane penetrating element extends to the exterior of the support housing;

and a second interlock moveable between a collector lock position blocking movement of the bodily fluid collection element to the delivery position and a collector release position allowing movement of the bodily fluid collection element to the delivery position, the membrane penetrating element moving the second interlock from the collector lock position to the collector release position as the membrane penetrating element moves to the extended position.