Test media cassette for bodily fluid testing device

• US 7,785,272 B2
• Filed: 11/18/2005
• Issued: 08/31/2010
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/283,079
• Publication Number:
  US 20060079811A1
• Time in Patent Office: 1,747 Days
• Field of Search: 600/583, 600/584, 600/586, 600/556, 600/573, 205/778, 205/793, 204/222, 204/400, 204/403.08, 204/403.1, 204/409, 204/412, 204/415, 257/414, 435/817, 436/806, 436/170, 436/44, 222/144, 222/166, 141/100, 141/284, 414/421, 422/66
• 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 bodily fluid sampling device for analyzing a bodily fluid, comprising:

a test media cassette including

a test media tape adapted to collect the bodily fluid,

a supply portion storing an uncontaminated section of the test media tape that is uncontaminated with the bodily fluid, the supply portion including a supply reel, wherein the uncontaminated section of the test media tape is wound on the supply reel,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid, the storage portion including a take-up reel, wherein the contaminated section of the test media tape is wound on the take-up reel, and

an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to the bodily fluid;

a sensor positioned between the supply portion and the storage portion to sense at least one property of the bodily fluid collected on the test media tape at the exposure portion of the cassette;

a piercing device adapted to pierce skin;

an advancement mechanism to advance the test media tape in response to piercing of the skin by the piercing device; and

characterized in that the take-up reel has a geared portion that engages a biased cassette pawl that permits the take-up reel to rotate in only one direction so that test media can only be fed into the storage portion and not removed.

2. The bodily fluid sampling device of claim 1, further comprising:

wherein the test media tape includes a cover tape to preserve the test media tape; and

a cover reel attached to the cover tape, the cover reel being adapted to peel the cover tape from the test media tape before exposure to the bodily fluid.

3. The bodily fluid sampling device of claim 1, further comprising:

the test media tape defining a throughway to allow passage of the piercing device through the test media tape during piercing.

4. The bodily fluid sampling device of claim 1, further comprising an indicator adapted to indicate the number of available tests remaining in the cassette.

5. The bodily fluid sampling device of claim 1, wherein the sensor includes:

a light source/detector positioned remotely from the cassette;

a light transmission means coupled to the light source/detector, the transmission means being adapted to transmit light from the light source/detector onto the test media tape; and

a light detection means coupled to the light source/detector, the detection means being adapted to receive reflected light from the test media tape and transmit the reflected light to the light source/detector for analysis.

6. The body fluid sampling device of claim 5, wherein the advancement mechanism is mechanical and manually operated.

7. The bodily fluid sampling device of claim 1, further comprising:

a housing having a piercing portion configured to contact the skin; and

the advancement mechanism including a rack member attached to the piercing portion of the housing, wherein the biased cassette pawl prevents the geared portion from rotating when the piercing portion of the housing is pressed against the skin, the rack member being configured to rotate the geared portion as the piercing portion of the housing is released from the skin.

8. The bodily fluid sampling device of claim 7, further comprising:

wherein the test media tape includes a cover tape to preserve the test media tape; and

a cover reel attached to the cover tape, the cover reel being adapted to peel the cover tape from the test media tape before exposure to the bodily fluid.

9. The bodily fluid sampling device of claim 7, further comprising:

the test media tape defining a throughway to allow passage of the piercing device through the test media tape during piercing.

10. The bodily fluid sampling device of claim 7, further comprising an indicator adapted to indicate the number of available tests remaining in the cassette.

11. The bodily fluid sampling device of claim 7, wherein the sensor includes:

a light source/detector positioned remotely from the cassette;

a light transmission means coupled to the light source/detector, the transmission means being adapted to transmit light from the light source/detector onto the test media tape; and

a light detection means coupled to the light source/detector, the detection means being adapted to receive reflected light from the test media tape and transmit the reflected light to the light source/detector for analysis.

12. The body fluid sampling device of claim 11, wherein the advancement mechanism is mechanical and manually operated.