Integrated-testing system

• US 9,877,677 B2
• Filed: 01/14/2015
• Issued: 01/30/2018
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Charlton, Steven C.
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US14/596,390
• Publication Number:
  US 20150126838A1
• Time in Patent Office: 1,112 Days
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15113 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 5/15126 Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

An integrated-testing system includes a meter, a lancing device and a storage case. The meter includes a housing, a display and a processor. The storage case holds the meter and the lancing device in a relatively fixed position to each other. The meter and the lancing device are maintained in the storage case in the relatively fixed position until a fluid sample is desired, at which time a first portion of the lancing device is advanced to a position external to the storage case to obtain the fluid sample and a second portion of the lancing device remains relatively fixed in the storage case while the fluid sample is obtained.

Claims

1. An integrated testing system for determining analyte information, the integrated testing system comprising:

a meter including a meter housing, a display device, and a processor operable to determine information related to an analyte in a fluid sample;

a lancing device including a lancing-device housing and a lancet, the lancet being movably mounted inside the lancing-device housing to transition between a retracted position and a lancing position, the lancet being disposed in the lancing-device housing when the lancet is in the retracted position, and the lancet protruding at least partially from the lancing-device housing when the lancet is in the lancing position;

a storage case storing therein the meter and the lancing device, the storage case including a rigid base portion and a plurality of pins attached to the base portion, the lancing-device housing being movably mounted to the storage case via the plurality of pins, wherein the lancing device slides on the pins between an internal position, whereat the lancing-device housing is stowed inside the storage case, and an external position, whereat a first portion of the lancing-device housing protrudes from the storage case, such that a fluid sample can be lanced when the lancet is moved to the lancing position, and a second portion of the lancing-device housing remains in the storage case; and

a trigger coupled to at least one of the plurality of pins, the trigger configured to engage a surface of the lancet prior to the lancet moving to the lancing position.

2. The integrated testing system of claim 1, wherein the lancing-device housing includes a plurality of slots slidably receiving therein the plurality of pins of the storage case.

3. The integrated testing system of claim 2, wherein the lancing device slides rectilinearly from the internal position to the external position.

4. The integrated testing system of claim 1, wherein the storage case further comprises a pivot rigidly attached to the base portion, and the lancing device further comprises an operational grip rotatably attached to the pivot, wherein rotating the operational grip causes the lancing device to slide on the pins between the internal and external positions.

5. The integrated testing system of claim 4, wherein the lancing device further comprises a cam rotatably attached to the lancing-device housing, and wherein the operational grip is rotatably attached to the cam.

6. The integrated testing system of claim 1, further comprising a body-retraction spring biasing the lancing device towards the internal position.

7. The integrated testing system of claim 1, wherein the storage case further includes a rigid cover portion covering at least a front of the rigid base portion to enclose the meter and the lancing device inside the storage case.

8. The integrated testing system of claim 1, wherein the storage case further includes a flexible material covering at least a front of the rigid base portion to enclose the meter and the lancing device inside the storage case.

9. The integrated testing system of claim 1, wherein the meter is rigidly mounted entirely inside the storage case.

10. The integrated testing system of claim 9, wherein the meter housing includes a test-sensor opening through which a test sensor is received, the test-sensor opening being accessible through the storage case.

11. The integrated testing system of claim 9, wherein the storage case includes one or more attaching features maintaining the meter inside the storage case, the attaching features including pins, guides, clips, or elastomeric attachments, or any combination thereof.

12. The integrated testing system of claim 1, wherein the lancing device further includes a cocking lever, the cocking lever being configured to maintain the second portion of the lancing-device housing stationary in the storage case when the first portion of the lancing-device housing protrudes from the storage case.

13. The integrated testing system of claim 1, the storage case further including a storage area configured to store a plurality of test sensors.

14. The integrated testing system of claim 1, wherein the trigger is configured to rotate about the at least one of the plurality of pins.

15. A method for assembling an integrated testing system for determining analyte information, the method comprising:

providing a meter including a meter housing, a display device attached to the meter housing, and a processor attached to the meter housing, the processor being operable to determine information related to an analyte in a fluid sample;

providing a lancing device including a lancing-device housing and a lancet, the lancet being movably mounted inside the lancing-device housing to transition between a retracted position and a lancing position, the lancet being disposed in the lancing-device housing when the lancet is in the retracted position, and the lancet protruding at least partially from the lancing-device housing when the lancet is in the lancing position; and

providing a storage case including a rigid base portion and a plurality of pins rigidly attached to the base portion;

mounting the meter to the storage case;

mounting the lancing device to the storage case via the plurality of pins, wherein the lancing device is configured to slide on the pins between an internal position, whereat the lancing-device housing is stowed inside the storage case, and an external position, whereat a first portion of the lancing-device housing protrudes from the storage case, such that a fluid sample can be lanced when the lancet is moved to the lancing position, and a second portion of the lancing-device housing remains in the storage case; and

coupling a trigger to at least one of the plurality of pins, the trigger configured to engage a surface of the lancet prior to the lancet moving to the lancing position.

16. The method of claim 15, wherein the lancing-device housing includes a plurality of slots slidably receiving therein the plurality of pins when the lancing device is mounted to the storage case.

17. The method of claim 15, wherein the storage case further comprises a pivot rigidly attached to the base portion, and the lancing device further comprises an operational grip, the method further comprising rotatably attaching the operational grip to the pivot such that rotating the operational grip causes the lancing device to slide on the pins between the internal and external positions.

18. The method of claim 17, wherein the lancing device further comprises a cam rotatably attached to the lancing-device housing, and wherein the operational grip is rotatably attached to the cam.

19. The method of claim 15, further comprising attaching a body-retraction spring to the storage case, the body-retraction spring biasing the lancing device towards the internal position.

20. The method of claim 15, further comprising storing a plurality of test sensors in a storage area of the storage case.

21. A glucose testing system for determining a glucose concentration in a fluid sample received by a test strip, the glucose testing system comprising:

a meter with a meter housing, an electronic display device mounted on the meter housing, a processor stowed within the meter housing, and a test sensor opening defined in the meter housing and configured to receive therethrough the test trip with the fluid sample, the processor being operable to determine information related to an analyte in a fluid sample;

a lancing device with a lancing-device housing and a lancet movably mounted inside the lancing-device housing to transition between a retracted position, whereat the lancet is disposed entirely inside the lancing-device housing, and a lancing position, whereat the lancet protrudes at least partially from the lancing-device housing, the lancing-device housing including a plurality of elongated slots;

a storage case storing therein the meter and the lancing device, the storage case including a rigid polymeric portion and a cover portion covering at least a front of the rigid polymeric portion, both the meter and the lancing device being movable within and removable from the storage case, the storage case including a plurality of pins rigidly attached to the base portion, the elongated slots of the lancing-device housing receiving therein the plurality of pins to thereby movably mount the lancing device in the storage case, wherein the lancing device slides on the pins between an internal position, whereat the lancing-device housing is stowed inside the storage case, and an external position, whereat a first portion of the lancing-device housing protrudes from the storage case, such that a fluid sample can be lanced when the lancet is moved to the lancing position, and a second portion of the lancing-device housing remains in the storage case; and

a trigger coupled to at least one of the plurality of pins, the trigger configured to engage a surface of the lancet prior to the lancet moving to the lancing position.

22. The glucose testing system of claim 21, wherein the trigger is configured to rotate about the at least one of the plurality of pins and to engage the surface of the lancet when the lancing device is at an external position.