SYSTEMS, DEVICES, MEDIA, AND METHODS FOR MEASURING ANALYTES IN BIOLOGICAL FLUIDS

• US 20160363603A1
• Filed: 07/01/2016
• Published: 12/15/2016
• Est. Priority Date: 07/31/2013
• Status: Abandoned Application

• Current Assignee: Sentec Pte Ltd
• Original Assignee: Robert Allen Ray, Roobik Azarnia
• Inventors: AZARNIA, Roobik, RAY, Robert Allen
• Application Number:
  US15/201,296
• Publication Number:
  US 20160363603A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

A replaceable cartridge for a biological analyte measurement device includes housing configured for removable engagement therefrom, and a support medium disposed within the housing. The support medium carries test pads made of a thin layer of fluid transporting material, and hermetic isolation pads made of a fluid impermeable material. The housing provides a port through which test pads are exposable to an external environment; and a set of sealing elements that define a cross sectional area within a channel internal to the housing, through which the support medium, test pads, and hermetic isolation pads are displaceable. Engagement of a hermetic isolation with the set of sealing elements results in the formation of a hermetic seal within the housing. Hermetic isolation pads can be formed as portions of cleanse pads that can be wiped across surfaces corresponding to a set of sensors, or as sealing pads separate from cleanse pads.

Claims

1. A cartridge for a biological analyte measurement device, the cartridge comprising:

a continuous elongate test tape having a length, a thickness, an outer surface, an inner surface, wherein the test tape carries a reagent along portions of its length reactive to a particular biological analyte;

a set of sensors configured for detecting a presence or a level of the particular biological analyte;

a housing carrying each of the test tape and the set of sensors, the housing removably engageable with the biological analyte measurement device such that the test tape and the set of sensors carried by the housing are replaceable with respect to the biological analyte measurement device, the housing comprising;

a source compartment within which an unused portion of the test tape resides;

a destination compartment within which a used portion of the test tape resides;

an aperture disposed between the source compartment and the destination compartment, which is exposable to an environment external to the housing, and at which the set of electrodes resides;

a set of drive mechanisms engageable or engaged with the test tape, by which portions of the test tape are advanced in a forward motion direction from the source compartment, across the aperture, and into the destination compartment; and

a set of engagement structures that facilitate engagement of the cartridge with and disengagement of the cartridge from the biological analyte measurement device,

wherein at the aperture the inner surface of the test tape folds around and is retained against or adjacent to the set of sensors and the outer surface of the test tape is exposable to a fluid sample at a current fluid sampling region of the test tape disposed at the aperture, and

wherein the fluid sample received at the current fluid sampling region need only be transported through the thickness of the test tape for detection of the particular biological analyte by the set of sensors.

2. The cartridge of claim 1, wherein the set of sensors comprises an electrochemical sensor, an electrochemiluminescence (ECL) sensor, an optical sensor, or a combination thereof.

3. The cartridge of claim 1, wherein the cartridge, including the test tape and the set of sensors carried thereby, is replaceable or disposable.

4. The cartridge of claim 1, wherein the housing further comprises:

a plurality of internal surfaces providing a primary channel having a primary cross sectional area through which the test is displaced; and

at least one set of sealing elements that occupies a portion of the primary cross sectional area along a portion of the primary channel to define a secondary channel through which the test tape is displaceable, the secondary channel having a secondary cross sectional area smaller than the primary cross sectional area, wherein the at least one set of sealing elements is engageable with the test tape when the test tape is displaced through the secondary channel,

wherein engagement of the test tape with the set of sealing elements enables the formation of a hermetic seal within the housing that isolates portions of the primary channel from the environment external to the housing.

5. The replaceable cartridge of claim 4, wherein the at least one set of sealing elements includes a first set of sealing elements disposed proximate to the aperture and/or the set of sensors.

6. The replaceable cartridge of claim 4, wherein the at least one set of sealing elements comprises a first set of sealing elements disposed at a first predetermined location relative to the primary channel, and a second set of sealing elements disposed at a second predetermined location relative to the primary channel, wherein the first set of sealing elements resides closer to the aperture than the second set of sealing elements.

7. The cartridge of claim 1, wherein the housing carries at least one type of desiccant material therein.

8. The cartridge of claim 7, wherein the housing carries a desiccant material spray-applied onto internally exposed source compartment walls.

9. The cartridge of claim 7, wherein the housing carries a desiccant material in packet form secured to a source compartment recess, cavity, or slot.

10. The cartridge of claim 1, further comprising a source spool disposed in the source compartment, around which the test tape is wound and from which the test tape is fed in association with displacement of the tape structure in the forward motion direction.

11. The cartridge of claim 1, further comprising a destination spool disposed in the destination compartment around which the test tape is wound in association with displacement of the test tape in the forward motion direction.

12. The cartridge of claim 1, wherein the test tape further comprises a plurality of cleanse zones disposed along the length of the test tape.