Test media cassette for bodily fluid testing device

• US 8,192,372 B2
• Filed: 07/21/2010
• Issued: 06/05/2012
• Est. Priority Date: 06/08/2001
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Roe, Steven N.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/840,352
• Publication Number:
  US 20100286564A1
• Time in Patent Office: 685 Days
• Field of Search: 600/583, 600/584, 205/778, 205/793, 204/400, 204/403.01, 204/403.03, 606181-183
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• 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 5/14546 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 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes 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 5/150503 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising
• CPC Class Codes: G01N 2035/00019 cassette structures
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02
• CPC Class Codes: G01N 33/48764 : Test tape taken off a spool
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Claims

1. A cassette, comprising:

a test tape having a plurality of test sections to test a plurality of body fluid samples;

a cover protecting the test tape prior to use, wherein the cover is a layer over the test tape; and

an exposure device configured to permit access to a test section of the test tape covered by the cover.

2. The cassette of claim 1, wherein the exposure device includes a cover reel configured to wind the cover therearound to peel the cover from the test tape.

3. The cassette of claim 2, further comprising:

a supply reel comprising the test tape prior to use; and

a take-up reel comprising the test tape after use.

4. The cassette of claim 1, wherein:

the cover includes a plurality of blister packs covering the test sections; and

the exposure device includes a cutting device configured to pierce the blister packs to expose the test sections.

5. The cassette of claim 1, wherein:

the cover includes a seal membrane; and

the exposure device includes a piercing device configured to pierce the seal membrane.

6. The cassette of claim 3, further comprising:

an outer cover including

an unexposed media supply portion, wherein the supply reel is located inside the unexposed media supply portion,

an exposed media storage portion, wherein the take-up reel is located inside the exposed media storage portion, and

a testing portion located between the unexposed media supply portion and the exposed media storage portion.

7. The cassette of claim 3, further comprising a peel tab configured to peel the cover from the test tape.

8. The cassette of claim 7, further comprising guides configured to guide the test tape between the supply reel and the take-up reel.

9. The cassette of claim 3, wherein:

the supply reel has a supply gear;

the cover reel has a cover gear; and

the supply gear and the cover gear are intermeshed to synchronize rotation of the supply reel and the cover reel.

10. The cassette of claim 1, further comprising:

a supply reel comprising the test tape prior to use; and

a take-up reel comprising the test tape after use.

11. The cassette of claim 10, further comprising:

an outer cover including

an unexposed media supply portion, wherein the supply reel is located inside the unexposed media supply portion,

an exposed media storage portion, wherein the take-up reel is located inside the exposed media storage portion, and

a testing portion located between the unexposed media supply portion and the exposed media storage portion.

12. The cassette of claim 4, wherein the test tape has a piercing device hole between adjacent test sections.

13. The cassette of claim 4, wherein the blister pack is a plastic film.

14. The cassette of claim 4, wherein the test sections include test media that is semitransparent or transparent to allow optical analysis of the body fluid samples.

15. The cassette of claim 5, wherein each of the test sections has a vacuum passageway and a test pad positioned between the seal membrane and the vacuum passageway.

16. A cassette, comprising:

a test tape having a plurality of test sections to test a plurality of body fluid samples;

a cover configured to protect the test tape prior to use; and

an exposure device configured to permit access to a test section of the test tape covered by the cover, wherein the exposure device includes a cover reel configured to wind the cover therearound to peel the cover from the test tape.

17. The cassette of claim 16, further comprising:

a supply reel comprising the test tape prior to use; and

a take-up reel comprising the test tape after use.

18. The cassette of claim 17, further comprising:

an outer cover including

an unexposed media supply portion, wherein the supply reel is located inside the unexposed media supply portion,

an exposed media storage portion, wherein the take-up reel is located inside the exposed media storage portion, and

a testing portion located between the unexposed media supply portion and the exposed media storage portion.

19. The cassette of claim 17, wherein:

the supply reel has a supply gear;

the cover reel has a cover gear; and

the supply gear and the cover gear are intermeshed to synchronize rotation of the supply reel and the cover reel.

20. The cassette of claim 17, further comprising guides configured to guide the test tape between the supply reel and the take-up reel.

21. The cassette of claim 16, further comprising a peel tab configured to peel the cover from the test tape.

22. A cassette, comprising:

a test tape having a plurality of test sections to test a plurality of body fluid samples;

a cover configured to protect the test tape prior to use, wherein the cover includes a plurality of blister packs for covering the test sections; and

an exposure device configured to permit access to a test section of the test tape covered by the cover, wherein the exposure device includes a cutting device configured to pierce the blister packs to expose the test sections.

23. The cassette of claim 22, further comprising:

a supply reel comprising the test tape prior to use; and

a take-up reel comprising the test tape after use.

24. The cassette of claim 23, further comprising:

an outer cover including

an unexposed media supply portion, wherein the supply reel is located inside the unexposed media supply portion,

an exposed media storage portion, wherein the take-up reel is located inside the exposed media storage portion, and

a testing portion located between the unexposed media supply portion and the exposed media storage portion.

25. The cassette of claim 22, wherein the test tape has a piercing device hole between adjacent test sections.

26. The cassette of claim 22, wherein the blister pack is a plastic film.

27. The cassette of claim 22, wherein the test sections include test media that is semitransparent or transparent to allow optical analysis of the body fluid samples.

28. A cassette, comprising:

a test tape having a plurality of test sections to test a plurality of body fluid samples;

a cover configured to protect the test tape prior to use, wherein the cover includes a seal membrane; and

an exposure device configured to permit access to a test section of the test tape covered by the cover, wherein the exposure device includes a piercing device configured to pierce the seal membrane.

29. The cassette of claim 28, wherein each of the test sections has a vacuum passageway and a test pad positioned between the seal membrane and the vacuum passageway.