Systems, Devices, Media, and Methods for Measuring Analytes in Biological Fluids

• US 20150037228A1
• Filed: 07/31/2014
• Published: 02/05/2015
• Est. Priority Date: 07/31/2013
• Status: Abandoned Application

• Current Assignee: Sentec Pte Ltd
• Original Assignee: Sentec Pte Ltd
• Inventors: AZARNIA, Roobik, RAY, Robert Allen
• Application Number:
  US14/447,869
• Publication Number:
  US 20150037228A1
• Time in Patent Office: Days
• US Class Current: 422/554
• 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 test medium for a biological fluid analyte measurement device, the test medium comprising:

a support medium;

a plurality of test pads disposed along the support medium, each test pad comprising a thin layer of a fluid transporting material having a length that is continuous between a first end and a second end of the test pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the test pad, the layer of the fluid transporting material of each of the plurality of test pads comprising at least one of;

a fluid sampling region configured for receiving a small volume of a biological fluid sample; and

at least one analyte measurement region fluidically coupled to the fluid sampling region, the at least one analyte measurement region having a length,

wherein the fluid sampling region or the at least one analyte measurement region carries at least one reagent capable of reacting with an analyte that is expected to be present within the fluid sample; and

a plurality of hermetic isolation pads disposed along the support medium such that each of the plurality of hermetic isolation pads is located between a pair of test pads, each of the plurality of hermetic isolation pads comprising a fluid impermeable material, each of the plurality of hermetic isolation pads having a length between a first end and a second end of the hermetic isolation pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the hermetic isolation pad, wherein the cross sectional area of each of the plurality of hermetic isolation pads is greater than or equal to the cross sectional area of each of the plurality of test pads.

2. The test medium of claim 1, wherein the at least one analyte comprises blood glucose or blood cholesterol.

3. The test medium of claim 1, wherein the fluid transporting material of each of the plurality of test pads is configured for transporting a distinct fluid sample substantially throughout the entire thickness of the fluid transporting material in the fluid sampling region of the test pad.

4. The test medium of claim 1, wherein the fluid transporting material of each of the plurality of test pads is configured for transporting a distinct fluid sample substantially throughout the entire length of the analyte measurement region of the test pad.

5. The test medium of claim 1, wherein the fluid transporting material of each of the plurality of test pads is configured for transporting a distinct fluid sample substantially throughout the entire test pad.

6. The test medium of claim 1, wherein the fluid sampling region of each of the plurality of test pads has a length that spans a predetermined fraction of the test pad length away from the first end of the test pad.

7. The test medium of claim 1, wherein the fluid sampling region of each of the plurality of test pads has a length that spans a predetermined fraction of the test pad length in a segment of the test pad between the first end of the test pad and the second end of the test pad.

8. The test medium of claim 1, wherein each of the plurality of hermetic isolation pads comprises a cleanse-sealing pad including a material configured for wiping, absorbing, or wicking portions of a distinct fluid sample away from a surface or structure when wiped across the surface or structure, and wherein each cleanse-sealing pad is disposed adjacent to a test pad.

9. The test medium of claim 1, further comprising a plurality of cleanse pads distinct from the plurality of hermetic isolation pads, each of the plurality of cleanse pads including a material configured for wiping, absorbing, or wicking portions of a distinct fluid sample away from a surface or structure when wiped across the surface or structure, wherein each cleanse pad is disposed adjacent to a test pad and adjacent to a hermetic isolation pad.

10. The test medium of claim 1, wherein the plurality of test pads comprises a first set of test pads and a second set of test pads distinct from the first set of test pads, each test pad within the first set of test pads carrying a first reagent capable of reacting with a first analyte that is expected to be present within the fluid sample, and each test pad within the second set of test pads carrying a second reagent capable of reacting with a second analyte that is expected to be present within the fluid sample and which is different than the first analyte.

11. The test medium of claim 10, wherein the number of test pads within the first set of test pads significantly exceeds the number of test pads within the second set of test pads.

12. The test medium of claim 1, wherein each test pad within the plurality of test pads carries a first reagent capable of reacting with a first analyte and a second reagent capable of reacting with a second analyte different than the first analyte.

13. The test medium of claim 1, wherein the support medium comprises an elongate tape structure.

14. The test medium of claim 13, wherein the tape structure comprises:

a continuous length of the fluid transporting material between at least a first test pad and a last test pad of the plurality of test pads; and

a plurality of separation elements, each of the plurality of separation elements positioned between a pair of test pads, and each of the plurality of separation elements comprising a portion of the fluid transporting material that has been rendered fluid nontransporting or hydrophobic.

15. The test medium of claim 13, wherein the tape structure comprises a support layer having a continuous length between at least a first test pad and a last test pad of the plurality of test pads, and wherein each of the plurality of test pads and each of the plurality of hermetic isolation pads is disposed on the support medium.

16. The test medium of claim 15, wherein the support layer includes a first side and a second side along its length, and wherein the first side of the support layer carries an adhesive film to which at least a portion of each of the plurality of test pads is adhered.

17. The test medium of claim 15, wherein the elongate tape structure carries (a) a plurality of cleanse pads and/or cleanse-sealing pads disposed directly adjacent one another along a terminal end section of the elongate tape structure, or (b) an extended length cleanse pad or cleanse-sealing pad disposed at the terminal end section of the elongate tape structure.

18. The test medium of claim 1, wherein the fluid sampling region of each of the plurality of test pads is not adhered to the support medium, and wherein the analyte measurement region of each of the plurality of test pads is adhered to the support medium.

19. The test medium of claim 1, wherein the support medium comprises a structure having a circular profile or cross section.

20. The test medium of claim 1, wherein the support medium includes a plurality of indexing holes, each of the plurality of indexing holes configured for receiving an indexing pin.

21. A test medium for a biological fluid analyte measurement device, the test medium comprising:

a support medium;

a plurality of test pads disposed along the support medium, each test pad comprising a thin layer of a fluid transporting material having a length that is continuous between a first end and a second end of the test pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the test pad, the layer of the fluid transporting material of each of the plurality of test pads comprising at least one of;

a fluid sampling region configured for receiving a small volume of a biological fluid sample; and

at least one analyte measurement region fluidically coupled to the fluid sampling region, the at least one analyte measurement region having a length,

wherein the fluid sampling region or the at least one analyte measurement region is pre-loaded with at least one reagent capable of reacting with an analyte that is expected to be present within the fluid sample; and

a plurality of cleanse pads disposed along the support medium such that each of the plurality of cleanse pads is located between a pair of test pads, each of the plurality of cleanse pads having a length between a first end and a second end of the cleanse pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the cleanse pad, wherein the cross sectional area of each of the plurality of cleanse pads is greater than or equal to the cross sectional area of each of the plurality of test pads., wherein each of the plurality of cleanse pads is not pre-loaded with the at least one reagent, and wherein each of the plurality of cleanse pads comprises a material capable of wiping, absorbing, or wicking portions of the distinct fluid sample away from a surface corresponding to a set of sensors when wiped across the surface corresponding to the set of sensors in association with displacement of the support medium in a forward motion direction,

wherein the support medium comprises (a) a structure to which portions of test pads and cleanse pads are adhered, or (b) a structure made from the fluid transporting material and which has been rendered fluid nontransporting or hydrophobic at predetermined locations.

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

a support medium displaceable in a forward motion direction by way of a set of mechanical drive elements;

a plurality of test pads disposed along the support medium, each of the plurality of test pads positionable relative to a set of sensors, each of the plurality of test pads comprising a thin layer of a fluid transporting material having a length that is continuous between a first end and a second end of the test pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the test pad, the layer of the fluid transporting material of each of the plurality of test pads comprising at least one of;

a fluid sampling region configured for receiving a small volume of a biological fluid sample; and

at least one analyte measurement region corresponding to the fluid sampling region and carrying at least one reagent capable of reacting with an analyte that is expected to be present within the fluid sample, the at least one analyte measurement region having a length,

wherein the fluid sampling region or the at least one analyte measurement region carries at least one reagent capable of reacting with an analyte that is expected to be present within the fluid sample; and

a plurality of hermetic isolation pads disposed along the support medium such that each of the plurality of hermetic isolation pads is located between a pair of test pads, each of the plurality of hermetic isolation pads comprising a fluid impermeable material, each of the plurality of hermetic isolation pads having a length between a first end and a second end of the hermetic isolation pad, a width, a thickness, and a cross sectional area defined by the width and the thickness of the hermetic isolation pad, wherein the cross sectional area of each of the plurality of hermetic isolation pads is greater than or equal to the cross sectional area of each of the plurality of test pads; and

a housing in which the support medium resides and which is configured for removable engagement with the analyte measurement device, the housing comprising;

a plurality of internal surfaces providing a primary channel having a primary cross sectional area through which the support medium, each of the plurality of test pads, and each of the plurality of hermetic isolation pads are displaceable;

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 support medium, each of the plurality of test pads, and each of the plurality of hermetic isolation pads are 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 each of the plurality of hermetic isolation pads when the hermetic isolation pad is displaced through portions of the secondary channel; and

a port through which each of the plurality of test pads is exposable to an environment external to the housing,

wherein engagement of a hermetic isolation pad of the plurality of hermetic isolation pads with the at least one 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.

23. The replaceable cartridge of claim 22, wherein the at least one set of sealing elements includes a first set of sealing elements disposed proximate to the port and/or the set of sensors.

24. The replaceable cartridge of claim 22, 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 port than the second set of sealing elements.

25. The replaceable cartridge of claim 24, wherein the first set of sealing elements is configured for engaging with a first hermetic isolation element of the plurality of hermetic isolation elements, and wherein the second set of sealing elements is configured for engaging with a second hermetic isolation element of the plurality of hermetic isolation elements distinct from the first hermetic isolation element.

26. The replaceable cartridge of claim 22, further comprising a set of sensors carried by the housing, the set of sensors configured for detecting the presence or level of at least one analyte within a distinct fluid sample transported from the fluid sampling region of a test pad of the plurality of test pads into the at least one analyte measurement region of the test pad.

27. The replaceable cartridge of claim 26, wherein each of the plurality of hermetic isolation pads comprises a cleanse-sealing pad disposed adjacent to a test pad, each of the cleanse-sealing pads including a material configured for wiping, absorbing, or wicking portions of the distinct fluid sample away from a surface corresponding to the set of sensors when wiped across the surface corresponding to the set of sensors.

28. The replaceable cartridge of claim 26, further comprising a plurality of cleanse pads distinct form the plurality of hermetic isolation pads, each of the plurality of cleanse pads disposed adjacent to a test pad and adjacent to a hermetic isolation pad, each of the plurality of cleanse pads including a material configured for wiping, absorbing, or wicking portions of a distinct fluid sample away from a surface corresponding to the set of sensors when wiped across the surface corresponding to the set of sensors.

29. The replaceable cartridge of claim 26, wherein the cartridge, including the set of sensors carried thereby, is disposable.

30. The replaceable cartridge of claim 26, wherein the set of sensors includes at least one of an electrochemical sensor, an electrochemiluminescence sensor, and an optical sensor.

31. The replaceable cartridge of claim 26, wherein the set of sensors includes a first sensor and a second sensor that operates in accordance with a different sensing modality than the first sensor.

32. The replaceable cartridge of claim 22, further comprising at least one desiccant material disposed within the housing.

33. The replaceable cartridge of claim 22, wherein the support medium comprises an elongate tape structure or a structure having a circular profile or cross section.

34. The replaceable cartridge of claim 22, wherein the cartridge is configured for indexed displacement in the forward motion direction by way of the set of mechanical drive elements.

35. The replaceable cartridge of claim 34, wherein the cartridge carries passive mechanical drive elements and excludes active mechanical drive elements configured to drive the passive drive elements.

36. The replaceable cartridge of claim 34, wherein the support medium comprise an elongate tape structure, and wherein the replaceable cartridge further comprises a source compartment in which test pads of the plurality of test pads that have not been exposed to the external environment reside, and a destination compartment in which test pads of the plurality of test pads that have been exposed to the external environment reside.

37. The replaceable cartridge of claim 36, wherein successive indexed displacement of the support medium in the forward motion direction successively transfers test pads from the source compartment into the primary channel of the replaceable cartridge.

38. The replaceable cartridge of claim 36, further comprising a destination spool disposed in the destination compartment, around which the tape structure can be wound in association with displacement of the tape structure in the forward motion direction.

39. The replaceable cartridge of claim 36, further comprising a source spool disposed in the source compartment, around which the tape structure is wound and from which the tape structure can be fed into the primary channel of the replaceable cartridge in association with displacement of the tape structure in the forward direction.