Test media cassette for bodily fluid testing device

• US 6,988,996 B2
• Filed: 06/07/2002
• Issued: 01/24/2006
• 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, Steven N., Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Szmal, Brian
• Application Number:
  US10/164,828
• Publication Number:
  US 20020188224A1
• Time in Patent Office: 1,327 Days
• Field of Search: 600/584, 600/583, 600/586, 600/556, 600/573, 600/575, 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, 436/165, 222/144, 222/166, 144/100, 144/284, 414/421, 422/66, 422/67, 422/56, 422/102, 422/104, 422/58, 422/62, 422/944, 356/440, 205/778, 205/793
• 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,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid,

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; and

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

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

the supply portion includes a supply reel, wherein the uncontaminated section of the test media tape is wound on the supply reel; and

the storage portion includes a storage reel, wherein the contaminated section of the test media tape is wound on the storage reel.

3. The bodily fluid sampling device of claim 2, 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.

4. The bodily fluid sampling device of claim 1, wherein the test media tape includes:

a test pad containing chemicals for testing the bodily fluid; and

a blister pack positioned proximal to the test pad, the blister pack having a raised surface adapted to draw the bodily fluid to the test pad through capillary action.

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

a vacuum assembly to generate a vacuum;

a piercing device adapted to pierce skin and draw the bodily fluid;

wherein the test media tape includes separate test sections, each test section including a vacuum passageway defined in the test media and a seal membrane, the seal membrane being adapted to be pierced and seal around the piercing device when the bodily fluid is collected, each test section further including a test pad positioned between the vacuum passageway and the seal membrane, the test pad being adapted to collect the bodily fluid; and

wherein the vacuum assembly being adapted to form a vacuum in the vacuum cavity to draw the bodily fluid up the piercing device and onto the test pad during testing.

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

a piercing device mounted on a first pivotal arm to pierce skin; and

wherein the cassette is coupled to a second pivotal arm to pivot the cassette into position to collect the bodily fluid after the piercing device pierces the skin.

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

a piercing device to pierce skin; and

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

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

the storage portion includes a storage reel and the contaminated section of the test media tape is wound on the storage reel; and

the advancement mechanism includes

a movable cover surrounding the piercing device, the movable cover being adapted to move and expose the piercing device during sampling, and

a rack member coupled between the movable cover and the storage reel to rotate the storage real upon movement of the movable cover.

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

10. 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.

11. A test cassette for collecting a bodily fluid sample, comprising:

a test media tape having a contaminated section that is contaminated with past samples of the bodily fluid and an uncontaminated section;

a cover including a supply portion in which the uncontaminated section of the test media tape is enclosed, the cover further including a storage portion in which the contaminated section of the test media tape is enclosed, the cover defining an exposure opening along the test media tape at which the test media tape is exposed to the bodily fluid;

a supply reel disposed in the supply portion of the cover around which the uncontaminated section of the test media tape is wrapped;

a storage reel disposed in the storage portion of the cover around which the contaminated section of the test media tape is wrapped; and

wherein the test media tape has a cover tape sealing the uncontaminated section of the test media tape.

12. The cassette of claim 11, wherein the cover defines a separate test opening at which the bodily fluid is tested.

13. The cassette of claim 12, wherein the test opening is positioned on an opposite side of the cover from the exposure opening, and the test opening is aligned with the exposure opening.

14. The cassette of claim 11, further comprising a cover reel attached to the cover tape, the cover reel being adapted to peel the cover tape from the test media tape.

15. The cassette of claim 11, wherein:

the test media tape includes a plurality of test sections;

each of the test sections includes a blister pack covering a test pad;

the blister pack being adapted to draw the bodily fluid up to the test pad; and

the test media tape defining a piercing device throughway between adjacent pairs of the test sections.

16. The cassette of claim 11, wherein:

the test media tape defines a vacuum passageway;

the test media tape includes a seal membrane adapted to seal around a piercing device; and

the test media tape includes a test pad positioned between the vacuum passageway and the seal membrane for collecting the bodily fluid.

17. 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,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid, 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;

wherein the supply portion includes a supply reel, wherein the uncontaminated section of the test media tape is wound on the supply reel;

wherein the storage portion includes a storage reel, wherein the contaminated section of the test media tape is wound on the storage reel; and

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.

18. 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,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid,

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 vacuum assembly to generate a vacuum;

a piercing device adapted to pierce skin and draw the bodily fluid;

wherein the test media tape includes separate test sections, each test section including a vacuum passageway defined in the test media and a seal membrane, the seal membrane being adapted to be pierced and seal around the piercing device when the bodily fluid is collected, each test section further including a test pad positioned between the vacuum passageway and the seal membrane, the test pad being adapted to collect the bodily fluid; and

wherein the vacuum assembly being adapted to form a vacuum in the vacuum cavity to draw the bodily fluid up the piercing device and onto the test pad during testing.

19. 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,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid,

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 mounted on a first pivotal arm to pierce skin; and

wherein the cassette is coupled to a second pivotal arm to pivot the cassette into position to collect the bodily fluid after the piercing device pierces the skin.

20. 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,

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid,

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 to pierce skin;

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

the storage portion includes a storage reel and the contaminated section of the test media tape is wound on the storage reel; and

the advancement mechanism includes

a movable cover surrounding the piercing device, the movable cover being adapted to move and expose the piercing device during sampling, and

a rack member coupled between the movable cover and the storage reel to rotate the storage reel upon movement of the movable cover.

21. A test cassette for collecting a bodily fluid sample, comprising:

a test media tape having a contaminated section that is contaminated with past samples of the bodily fluid and an uncontaminated section;

a cover including a supply portion in which the uncontaminated section of the test media tape is enclosed, the cover further including a storage portion in which the contaminated section of the test media tape is enclosed, the cover defining an exposure opening along the test media tape at which the test media tape is exposed to the bodily fluid;

a supply reel disposed in the supply portion of the cover around which the uncontaminated section of the test media tape is wrapped;

a storage reel disposed in the storage portion of the cover around which the contaminated section of the test media tape is wrapped;

wherein the test media tape includes a plurality of test sections;

wherein each of the test sections includes a blister pack covering a test pad;

wherein the blister pack being adapted to draw the bodily fluid up to the test pad; and

wherein the test media tape defining a piercing device throughway between adjacent pairs of the test sections.

22. A test cassette for collecting a bodily fluid sample, comprising:

a test media tape having a contaminated section that is contaminated with past samples of the bodily fluid and an uncontaminated section;

a cover including a supply portion in which the uncontaminated section of the test media tape is enclosed, the cover further including a storage portion in which the contaminated section of the test media tape is enclosed, the cover defining an exposure opening along the test media tape at which the test media tape is exposed to the bodily fluid;

a supply reel disposed in the supply portion of the cover around which the uncontaminated section of the test media tape is wrapped;

a storage reel disposed in the storage portion of the cover around which the contaminated section of the test media tape is wrapped;

wherein the test media tape defines a vacuum passageway;

wherein the test media tape includes a seal membrane adapted to seal around a piercing device; and

wherein the test media tape includes a test pad positioned between the vacuum passageway and the seal membrane for collecting the bodily fluid.

23. A test cassette, comprising:

a test tape configured to analyze more than one body fluid sample;

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

means for peeling the cover tape from the test tape.

24. The test cassette of claim 23, wherein the means for peeling the cover tape includes a cover reel around which the cover tape is wound.

25. The test cassette of claim 23, further comprising:

a supply reel around which the test tape is wound prior to use; and

a take-up reel around which the test tape is wound after use.

26. A test media cassette for analyzing a bodily fluid, comprising:

a test media tape adapted to analyze the bodily fluid;

a supply portion storing an uncontaminated section of the test media tape that is uncontaminated with the bodily fluid;

a storage portion storing a contaminated section of the test media tape that is contaminated with the bodily fluid; and

wherein the test media tape includes a plurality of blister packs each having a raised surface with an opening for drawing the bodily fluid to the test media tape through capillary action.

27. The test media cassette of claim 26, further comprising a cutting device for creating the opening in the blister packs to draw the bodily fluid.

28. A bodily fluid sampling device, comprising:

a piercing device to form an incision in tissue;

a test media cassette including

a test media tape adapted to analyze body fluid from the incision,

a supply portion storing an uncontaminated section of the test media tape that is uncontaminated with the body fluid, and

a storage portion storing a contaminated section of the test media tape that is contaminated with the body fluid;

an advancement mechanism configured to advance the contaminated section of the test media tape into the storage portion in response to piercing of the skin by the piercing device.

29. The bodily fluid sampling device of claim 28, wherein the advancement mechanism includes:

a movable cover surrounding the piercing device, the movable cover being adapted to move and expose the piercing device during sampling; and

a rack member coupled between the movable cover and the storage reel to rotate the storage real upon movement of the movable cover.