Integrated Test System for Monitoring Bodily Fluids

• US 20090326355A1
• Filed: 08/11/2006
• Published: 12/31/2009
• Est. Priority Date: 08/12/2005
• Status: Abandoned Application

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Schlagheck, Julian, Reynolds, Jeffery S., Brenneman, Allen J., Kuriger, Rex J.
• Application Number:
  US11/990,197
• Publication Number:
  US 20090326355A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An integrated diagnostic instrument (10) for analyzing a fluid sample includes a housing (12), a sensor pack (122), a disk drive mechanism (200) and a lancing mechanism (16). The lancing mechanism includes a lance holder (110) adapted to removably engage a base of a lance (86), a plunger (66) coupled to the lance holder, a shaft (70) running through a central portion of the plunger, a spring at least partially surrounding the shaft, and a slider (90) located on a rail on the exterior of the housing.

Claims

1. An integrated diagnostic instrument for analyzing a fluid sample, comprising:

a housing having an exterior and a sensor opening formed therein;

a sensor pack having a plurality of sensor cavities, each of the plurality of sensor cavities being adapted to house a test sensor therein, the test sensor being adapted to assist in the determination of an analyte concentration in the fluid sample;

a disk drive mechanism disposed in the housing and moveable between a standby position, an extended position, and a testing position, the disk drive mechanism removing a test sensor from the sensor pack and partially ejecting the test sensor through the sensor opening of the housing as the disk drive mechanism is moved between positions; and

a lancing mechanism having

(i) a lance holder adapted to removably engages a base of a lance,

(ii) a plunger coupled to the lance holder, the plunger having a central portion,

(iii) a shaft running through the central portion of the plunger, the plunger being adapted to move along the shaft, the shaft having an end portion that is adapted to secure the shaft to the integrated diagnostic instrument,

(iv) a spring at least partially surrounding the shaft, the spring being located between the plunger and the end portion of the shaft, and

(v) a slider located on a rail on the exterior of the housing, the slider being adapted to move along the rail in a first direction to compress the spring and wherein the decompressing of the spring causes the plunger and lance holder to rapidly move in a second direction opposite the first direction.

2. The integrated diagnostic instrument of claim 1, the lancing mechanism further having a firing button located on a slider dock, the firing button being adapted to allow the spring to rapidly decompress when the firing button is depressed.

3. The integrated diagnostic instrument of claim 1, the lancing mechanism further having an endcap that covers the plunger, the endcap being adapted to regulate the distance the spring can cause the plunger and lance holder to move in the second direction.

4. The integrated diagnostic instrument of claim 3, wherein the endcap is removably attached to the housing.

5. The integrated diagnostic instrument of claim 1, wherein the disk drive mechanism removes the test sensor from the sensor pack and partially ejects the test sensor through the sensor opening as the disk drive mechanism is moved from the extended position to the testing position.

6. The integrated diagnostic instrument of claim 1, wherein the sensor pack is substantially circular.

7. The integrated diagnostic instrument of claim 1, wherein the test sensors are stored within the sensor cavities in the sensor pack by enclosing the sensor cavities with foil.

8. The integrated diagnostic instrument of claim 1, the test sensor being adapted to electrochemically assist in the determination of an analyte concentration in the fluid sample.

9. The integrated diagnostic instrument of claim 1, wherein the lancing mechanism is offset from the sensor opening by at least 20 degrees.

10. A method for collecting and analyzing a concentration of an analyte in a fluid sample, comprising the acts of:

mounting a sensor pack on an indexing disk within a housing of an integrated diagnostic instrument, the sensor pack having a plurality of sensor cavities each being adapted to house a test sensor therein, the test sensor being adapted to assist in the determination of an analyte concentration in the fluid sample;

actuating a disk drive mechanism to remove a test sensor from the sensor pack and partially eject the test sensor through a sensor opening of the housing;

lancing the skin of a test subject with a lancing mechanism to obtain a fluid sample, the lancing mechanism at least partially contained within the housing of the integrated diagnostic instrument, the integrated diagnostic instrument being in a first position when lancing;

moving the integrated diagnostic instrument from the first position to a second position;

applying the obtained fluid sample from the test subject to the partially ejected test sensor, the integrated diagnostic instrument being in the second position when applying the obtained fluid sample; and

determining the analyte concentration of the fluid sample.

11. The method of claim 10, wherein the lancing of the skin includes

moving a slider in a first direction, the movement of the slider causing a plunger to move in the first direction and compress a spring, and

depressing a firing button causing the spring to decompress and move the plunger in a second direction, opposite the first direction.

12. The method of claim 10, wherein the fluid sample is a whole blood sample.

13. The method of claim 10, wherein the analyte is glucose in a whole blood sample.

14. The method of claim 10, wherein the sensor pack is mounted on the indexing disk by pivoting a lower case relative to an upper case to access the indexing disk, the lower case and the upper case form the housing.

15. The method of claim 10, wherein a substantially circular sensor pack is mounted on the indexing disk.

16. The method of claim 10, wherein the determination of the analyte concentration in the fluid sample is performed through an electrochemical analysis of the fluid sample.

17. The method of claim 10, wherein the integrated diagnostic instrument is moved at least 20 degrees from the first position to the second position.

18. The method of claim 10, wherein the integrated diagnostic instrument is moved at least 45 degrees from the first position to the second position.