Test media cassette for bodily fluid testing device

• US 8,257,277 B2
• Filed: 08/02/2010
• Issued: 09/04/2012
• 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:
  US12/848,282
• Publication Number:
  US 20100317935A1
• Time in Patent Office: 764 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
• 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 tape configured to protect protecting the test tape prior to use; and

a cover reel configured to peel the cover tape from the test tape.

2. 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.

3. The cassette of claim 2, further comprising:

the supply reel having a supply gear; and

the cover reel having a cover gear intermeshed with the supply gear to synchronize rotation of the cover reel with the supply reel.

4. The cassette of claim 3, further comprising:

a peel tab disposed along the cover tape to facilitate peeling of the cover tape from the test tape; and

guides disposed between the supply reel and the take-up reel for guiding the test media tape between the supply reel and the take-up reel.

5. A device for analyzing a body fluid, comprising:

a test media cassette including

a test media tape having chemistry adapted to analyze the body fluid,

a cover tape configured to form an airtight seal over the test media tape to preserve the chemistry of the test media tape,

a supply reel comprising an uncontaminated section of the test media tape,

a take-up reel comprising a contaminated section of the test media tape, and

a cover reel configured to peel the cover tape from the test media tape for exposing the test media tape to the body fluid.

6. The device of claim 5, further comprising:

the supply reel having a supply gear; and

the cover reel having a cover gear intermeshed with the supply gear to synchronize rotation of the cover reel with the supply reel.

7. The device of claim 6, further comprising:

a peel tab disposed along the cover tape to facilitate peeling of the cover tape from the test media tape; and

guides disposed between the supply reel and the take-up reel for guiding the test media tape between the supply reel and the take-up reel.

8. The device of claim 7, further comprising:

a sensor positioned between the supply reel and the take-up reel to sense at least one property of the body fluid on the test media tape.

9. The device of claim 5, further comprising:

a peel tab disposed along the cover tape to facilitate peeling of the cover tape from the test media tape; and

guides disposed between the supply reel and the take-up reel for guiding the test media tape between the supply reel and the take-up reel.

10. A method, comprising:

providing a test media cassette that includes a test media tape having test chemistry, a cover tape forming an airtight seal over the test media tape to preserve the test chemistry of the test media tape, a supply reel around which an uncontaminated section of the test media tape is wound, a take-up reel around which a contaminated section of the test media tape is wound, and a cover reel around which the cover tape is wound;

indexing the test media tape with the take-up reel;

exposing the test chemistry by peeling the cover tape from the test media tape with the cover reel; and

analyzing body fluid with the exposed test chemistry of the test media tape.

11. The method of claim 10, further comprising:

wherein the supply reel has a supply gear;

wherein the cover reel has a cover gear intermeshed with the supply gear; and

synchronizing rotation of the cover reel with the supply reel through the intermeshed supply gear and cover gear.

12. A device, comprising:

a test tape having a plurality of test sections to test a plurality of body fluid samples, each test section having a test pad positioned between a seal membrane and a vacuum passageway;

a piercing device having a distal tip adapted to pierce tissue and a proximal tip adapted to pierce the seal membrane, the piercing device having a cavity extending from the distal tip to the proximal tip to transport the body fluid samples to the test pad; and

a vacuum assembly configured to form a vacuum in the vacuum passageway for drawing the body fluid sample onto the test pad.

13. The device of claim 12, further comprising:

a holder configured to hold the piercing device, the holder including a spring disposed around the piercing device, and

a biasing member constructed to bias the piercing device away from the test tape, and

wherein the biasing member is collapsible when pressed against skin for piercing the membrane of the test tape with the proximal tip of the piercing device.

14. The device of claim 13, wherein the holder includes a stop ridge configured to engage the piercing device to prevent over penetration of the proximal tip of the piercing device.

15. The device of claim 12, further comprising

a supply reel comprising an uncontaminated section of the test tape;

a take-up reel comprising a contaminated section of the test tape; and

a sensor positioned along the test tape between the supply reel and the take up reel for analyzing the body fluid samples.

16. A method, comprising

providing a sampling device that includes a test tape, a piercing device, a sensor, and a vacuum assembly, wherein the test tape has a plurality of test sections, wherein each test section has a test pad positioned between a seal membrane and a vacuum passageway, wherein the piercing device has a distal tip, a proximal tip, and a cavity extending from the distal tip to the proximal tip;

piercing tissue with the distal tip of the piercing device by pressing the sampling device against the tissue;

piercing the seal membrane with the proximal tip of the piercing device during said piercing the tissue;

drawing body fluid onto the test pad via the cavity in the piercing device by applying a vacuum to the vacuum passageway with the vacuum assembly; and

analyzing the body fluid on test pad with the sensor.

17. The method of claim 16, further comprising:

wherein the sampling device includes a holder that holds the piercing device; and

wherein said piercing the tissue and said piercing the seal membrane include collapsing the holder as the sampling device is pressed against the tissue.