Integrated hinged cartridge housings for sample analysis

• US 9,415,389 B2
• Filed: 06/09/2014
• Issued: 08/16/2016
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Doyle, Kevin John, Wilkins, Paul, Withers, Mick, Cooper, Adrian, Noell, John Oakey
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US14/299,259
• Publication Number:
  US 20140301915A1
• Time in Patent Office: 799 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/50 Containers for the purpose of retaining a material to be analysed, e.g. test tubes devices for taking samples of blood A61B5/15
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: Y10T 156/1051 by folding
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material

Abstract

The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing comprising a first substantially rigid zone, a second substantially flexible zone, a hinge region, and at least one sensor recess containing a sensor. The housing is foldable about said hinge region to form a cartridge having a conduit over at least a portion of said sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.

Claims

1. A method of making a test cartridge for measuring an analyte or property of a liquid sample, the method comprising the steps of:

(a) molding a housing comprising a first substantially rigid zone and a second substantially flexible zone, wherein said housing has a top portion and a bottom portion separated by a hinge region wherein the top portion forms a top portion of a conduit and the bottom portion forms a bottom portion of said conduit, and said substantially rigid zone has at least one sensor recess;

(b) inserting a sensor into the at least one sensor recess;

(c) folding said housing at said hinge region; and

(d) sealing said housing in a closed position, wherein said sealing forms the cartridge, and the cartridge comprises said conduit over at least a portion of said sensor.

2. The method of claim 1, wherein the molding comprises injection molding.

3. The method of claim 1, wherein the method further comprises the step of molding a desiccant plastic material into the housing.

4. The method of claim 1, wherein the substantially rigid zone is formed in a first injection molding step and the substantially flexible zone is formed in a second injection molding step.

5. The method of claim 1, wherein the substantially rigid zone or the substantially flexible zone is molded as a single contiguous zone.

6. The method of claim 1, wherein the substantially flexible zone is molded as a plurality of non-contiguous flexible zones.

7. The method of claim 1, wherein said substantially rigid zone is molded from PETG.

8. The method of claim 1, wherein the substantially rigid zone is molded from a material selected from the group consisting of ABS, polycarbonate, polystyrene, Topaz, acrylic polymers, PMMA and combinations thereof.

9. The method of claim 1, wherein the substantially flexible zone is molded from a thermoplastic elastomer.

10. The method of claim 1, wherein the substantially flexible zone is molded from an injection moldable thermoplastic elastomer having modulus of elasticity at 100% strain as determined by ASTM D638 of from 0.1 to 6 MPa.

11. The method of claim 1, wherein said housing comprises one or more mating elements on either or both sides of said hinge region, and wherein folding engages the one or more mating elements in a secure manner to form said conduit.

12. The method of claim 11, wherein opposing mating elements may be mated by hot-staking, cold-staking or by a snap closure.

13. The method of claim 11, wherein the one or more mating elements are secured with glue to form said conduit.

14. The method of claim 1, wherein said housing comprises one or more welding regions on either or both sides of said hinge region, and wherein folding engages the one or more welding regions so that they are configured such that they may be welded together in a secure manner to form said conduit.

15. The method of claim 14, wherein said welding is selected from the group consisting of ultrasonic welding, laser welding and thermal welding.

16. The method of claim 1, further comprising inserting a pouch containing a fluid into the housing, before step (c).

17. The method of claim 1, wherein the at least one sensor recess comprises a plurality of recesses each of which contains at least one sensor.

18. The method of claim 1, further comprising securing the sensor to the at least one sensor recess by a liquid-tight seal formed by an adhesive tape.

19. The method of claim 1, further comprising securing the sensor to the at least one sensor recess by a liquid tight-seal formed by at least one of glue, a perimeter of formable resin or a dielectric grease.

20. A sample analysis cartridge, comprising:

(a) a housing having a sample entry orifice for receiving a fluid sample wherein said housing has a top portion and a bottom portion separated by a hinge region;

(b) a holding chamber disposed between the sample entry orifice and a capillary stop for forming a metered sample therebetween, wherein the capillary stop is formed of opposing housing portions and a substantially flexible portion disposed therebetween to seal said opposing housing portions in a liquid-tight manner; and

(c) a conduit disposed between the capillary stop and a sensor and being configured to deliver the metered sample from the capillary stop to the sensor.

21. The cartridge of claim 20, wherein the holding chamber has a ramped region in which the lateral cross-sectional area decreases in a distal direction from the sample entry orifice to the capillary stop.

22. The cartridge of claim 21, wherein the ramped region extends over at least 50 percent of the length of the holding chamber.

23. The cartridge of claim 22, wherein the ramped region comprises a ramp element on at least one of the top surface or the bottom surface of the holding chamber.

24. The cartridge of claim 23, wherein side walls of the holding chamber narrow at the capillary stop.

25. The cartridge of claim 20, wherein the housing comprises a top housing portion defining a top portion of the holding chamber, a bottom housing portion defining a bottom portion of the holding chamber, and wherein the top portion and the bottom portion are sealed together with one or more mating elements to form the holding chamber.

26. The cartridge of claim 25, wherein at least one of the top portion or the bottom portion include a sealing ridge for sealing opposing portions of the holding chamber.

27. The cartridge of claim 20, further comprising an air bladder in contact with said conduit and being configured to move the fluid sample past the capillary stop.