DIAGNOSTIC SYSTEM

• US 20130131479A1
• Filed: 03/18/2011
• Published: 05/23/2013
• Est. Priority Date: 03/19/2010
• Status: Abandoned Application

• Current Assignee: Atomo Diagnostics Pty Limited
• Original Assignee: Atomo Diagnostics Pty Limited
• Inventors: Siu, Eric, Johnson, Ian Frederick, Sokolov, Richard, Kelly, John Michael, Norcott, Alison Ruth, Dunn, Christopher David, Hueso, Ernesto Monis
• Application Number:
  US13/635,903
• Publication Number:
  US 20130131479A1
• Time in Patent Office: Days
• US Class Current: 600/367
• 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

A composite diagnostic system comprising a support member having a membrane penetration element; a bodily fluid collection point positioned for collection of a bodily fluid released by application of the membrane penetration element to a user'"'"'s body; a test material positioned in the support member such that in use the bodily fluid is brought into contact with the test material.

Claims

1. A composite diagnostic system comprising a support member having:

a membrane penetration element;

a bodily fluid collection point positioned for collection of a bodily fluid released by application of the membrane penetration element to a user'"'"'s body;

a test material positioned in the support member such that in use the bodily fluid is brought into contact with the test material.

2. A composite diagnostic system as defined in claim 1, wherein the test material comprises a test strip positioned in the composite diagnostic system.

3. A composite diagnostic system as defined in claim 1, wherein the test material comprises a test cassette positioned in the composite diagnostic system.

4. A composite diagnostic system as defined in claim 1, wherein the test material comprises a cartridge.

5. A composite diagnostic system as defined in claim 1, wherein the test material comprises an integrated circuit positioned within the diagnostic system.

6. A composite diagnostic system as defined in claim 1, wherein the test material comprises a reagent tube.

7. A composite diagnostic system as defined in any of the preceding claims, wherein the test material is removably positioned within the diagnostic system.

8. A composite diagnostic system as defined in any of the preceding claims, wherein the piercing arrangement comprises a lancet or 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 support member.

9. A composite diagnostic system as defined in claim 8, the system further comprising a lancet activator, wherein the lancet is moveable between the rest position and the actuated position by actuation of the lancet activator.

10. A composite diagnostic system as defined in claim 8 or 9, wherein the lancet is removably connected with the support member.

11. A composite diagnostic system as defined in claim 8 or 9, wherein the lancet is incorporated into the support member.

12. A composite diagnostic system as defined in claim 9, wherein the lancet activator is connected with the support member.

13. A composite diagnostic system as defined in any of the preceding claims, wherein the system further comprises reservoir adapted to contain a physiologically acceptable solution, the reservoir being adapted such that in use the physiologically acceptable solution is brought into contact with the test material along with the bodily fluid.

14. A composite diagnostic system as defined in claim 13, wherein the reservoir is incorporated into the support member.

15. A composite diagnostic system as defined in claim 13 or 14, the support member further comprising a solution delivery actuator, actuation of the solution delivery actuator causing the physiologically acceptable solution to be delivered to the test material.

16. A composite diagnostic system as defined in any one of claims 13-16, wherein the physiologically. acceptable solution is a buffer.

17. A composite diagnostic system as defined in any of the preceding claims, the system further comprising a swab locator located in the support member and adapted for associating an alcohol swab with the system.

18. A composite diagnostic system as defined in claim 17, wherein the swab locator comprises indicia or a depression.

19. A composite diagnostic system as defined in any of the preceding claims, the system further comprising a drying pad locator positioned in the support member for associating a drying pad with the system.

20. A composite diagnostic system as defined in any of the preceding claims, the system further comprising an adhesive bandage locator in the support member, adapted for associating an adhesive bandage with the system.

21. A composite diagnostic system as defined in claim 20 wherein the adhesive bandage locator comprises a slit extending into the support.

22. A composite diagnostic system as defined in any of the preceding claims, the system further comprising indicia denoting a method of using the system.

23. A composite diagnostic system as defined in any of the preceding claims, wherein the system is sized to be hand-held.

24. A composite diagnostic system as defined in any of the preceding claims, wherein the system is adapted to be held in a single hand.

25. A composite diagnostic system as defined in any of claims 1-22, wherein a portion of the body comprising the membrane penetration element and bodily fluid collection point is detachable from a portion of the body comprising the test material.

27. A composite diagnostic system as defined in any of the preceding claims, further comprising an interface element adapted to allow the system to interface with diagnostic equipment.

28. A composite diagnostic system as defined in claim 27, wherein the interface element comprises a removable portion of the system adapted to engage with diagnostic equipment.

29. A composite diagnostic system as defined in claim 28, wherein the removable portion comprises the test material.

30. A composite diagnostic system as defined in claim 27 wherein the interface element comprises an opening adapted to allow diagnostic equipment to interface with the system.

31. A composite diagnostic system as defined in claim 30, wherein the opening is positioned such that the test material can interface with the diagnostic equipment through the opening.

26. A composite diagnostic system adapted to be handheld and comprising two or more of a membrane penetration element, a bodily fluid collection point positioned for collection of a bodily fluid released by application of the membrane penetration element to a user'"'"'s body and a test material positioned in the support member such that in use the bodily fluid is brought into contact with the test material.