Integrated-testing system

• US 8,956,308 B2
• Filed: 09/22/2009
• Issued: 02/17/2015
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Charlton, Steven C.
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/564,513
• Publication Number:
  US 20100081967A1
• Time in Patent Office: 1,974 Days
• Field of Search: 600/573, 600/576, 600/578, 600/583, 606/181, 606/182
• US Class Current: 600/583
• 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 information related to an analyte in a fluid sample, the integrated-testing system comprising:

a meter including a meter housing, a display, and a processor;

a lancing device for obtaining the fluid sample, the 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

a storage case holding the meter and the lancing device, wherein the storage case includes a rigid portion and a flexible material covering at least a front of the rigid portion, the meter and the lancing device being movable within the storage case by manipulation of the flexible material,

wherein the meter and the lancing device are maintained in the storage case and;

(1) the lancing-device housing is moved relative to the storage case, via manipulation of the flexible material, until 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 in the storage case while the fluid sample is obtained, and (2) the lancet is operated to move relative to the lancing-device housing from the retracted position to the lancing position while the lancing-device housing remains fixed relative to the storage case.

2. The system of claim 1, wherein the rigid portion includes a rigid polymeric material.

3. The system of claim 1, wherein the storage case includes attaching features to maintain the relative positions of the meter and lancing device, the attaching features include pins, guides, clips, or elastomeric attachments, or any combination thereof.

4. The system of claim 1, wherein the flexible material includes a flexible fabric material.

5. The system of claim 1, wherein the meter includes a test sensor opening, the test sensor opening being accessible when the meter resides in the storage case.

6. The system of claim 5, wherein the test sensor opening of the meter aligns with openings in the rigid portion and the flexible material of the storage case for receiving a test sensor.

7. The system of claim 1, wherein the lancing device includes a cocking lever, the cocking lever assisting in keeping the second portion of the lancing device stationary in the storage case while the first portion of the lancing device is moved to the position external to the storage case.

8. The system of claim 7, wherein the first portion of the lancing device is retracted to a position inside of the storage case after a fluid sample is taken.

9. The system of claim 1, wherein the lancing device includes a pressure-sensitive device to initiate lancing of the user'"'"'s finger.

10. The system of claim 1, further including a storage area inside the storage case.

11. The system of claim 10, wherein the storage area in the storage case holds therein a plurality of test sensors.

12. The system of claim 1, wherein the flexible material at least partially surrounds the rigid portion of the storage case.

13. A method for determining information relating to an analyte in a fluid sample, the method comprising:

providing a storage case, a meter, and a lancing device, the storage case holding the meter and the lancing device, wherein the storage case includes a rigid portion and a flexible material covering at least a front of the rigid portion, the meter and the lancing device being movable within the storage case by manipulation of the flexible material, the 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 extending from the lancing-device housing when the lancet is in the lancing position;

manipulating the flexible material to move the lancing-device housing relative to the storage case until a first portion of the lancing device is advanced to a position external to the storage case while maintaining a second portion of the lancing device in the storage case;

operating the lancet to move relative to the lancing-device housing from the retracted position to the lancing position while the lancing-device housing remains fixed relative to the storage case;

lancing to obtain the fluid sample while the first portion of the lancing device remains external to the storage case and the second portion of the lancing device remains within an interior of the storage case;

applying the fluid sample to a test sensor; and

determining information relating to the analyte in the fluid sample when the meter is located in the storage case and the test sensor is located in a test sensor opening of the meter.

14. The method of claim 13, further comprising after the lancing, retracting the first portion of the lancing device to a position inside of the storage case.

15. The method of claim 13, wherein the applying of the fluid sample to the test sensor occurs after positioning the test sensor in the test-sensor opening of the meter.

16. The method of claim 13 wherein the lancing device includes a button to initiate the lancing to obtain the fluid sample.

17. The method of claim 13, wherein the flexible material includes a flexible fabric material.

18. The method of claim 13, wherein the lancing device includes a cocking lever, the cocking lever assisting in keeping the second portion of the lancing device stationary in the storage case while the first portion of the lancing device is moved to the position external to the storage case.

19. The method of claim 13, wherein the first portion of the lancing device is retracted to a position inside of the storage case after a fluid sample is taken.

20. The method of claim 13, wherein the lancing device includes a pressure-sensitive device to initiate lancing of the user'"'"'s finger.

21. An analyte testing system for determining a concentration of an analyte in a fluid sample received by a test strip, the analyte testing system comprising:

a meter with a meter housing, a display attached to 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;

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; and

a storage case removably storing therein the meter and the lancing device, the storage case including a rigid polymeric portion and a flexible fabric 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 by manipulation of the flexible fabric portion,

wherein the lancing-device housing is configured to be moved relative to the storage case, via manipulation of the flexible fabric portion, whereby (i) a first portion of the lancing-device housing is advanced to project out of the storage case while a second portion of the lancing-device housing remains inside the storage case such that the lancet, when in the lancing position, projects out of the storage case, and (ii) the first portion of the lancing-device housing is moved back inside the storage case.