Sensor dispensing instrument having an activation mechanism and methods of using the same

• US 7,279,130 B2
• Filed: 07/26/2002
• Issued: 10/09/2007
• Est. Priority Date: 08/13/2001
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brown, Michael K.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): HYUN, PAUL SANG HWA
• Application Number:
  US10/205,574
• Publication Number:
  US 20030031599A1
• Time in Patent Office: 1,901 Days
• Field of Search: 422/61, 422/64
• US Class Current: 422/64
• 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: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A sensor dispensing instrument adapted to handle a sensor pack containing a plurality of sensors and to perform a test using one of the sensors. The sensor dispensing instrument includes an outer housing and a mechanical mechanism contained therein for rotating the sensor pack and ejecting one of the sensors from the sensor pack and through a sensor slot on the housing. The sensor dispensing instrument also includes a puller handle for operating the mechanical mechanism. The puller handle is adapted to be grasped between the thumb and finger of a user'"'"'s hand, and is moveable between a testing position adjacent to the rear end of the outer housing and an extended position spaced outwardly from the rear end of the outer housing.

Claims

1. A sensor dispensing instrument adapted to handle a sensor pack containing a plurality of sensors, each of said plurality of sensors being disposed in a sensor cavity on said sensor pack and enclosed by a protective covering, said sensor dispensing instrument further adapted to perform a test using one of said plurality of sensors, said sensor dispensing instrument comprising:

an outer housing having a front end and a rear end, said outer housing further comprising a sensor slot through which one of said sensors is disposed to conduct the test, said sensor slot being disposed at the front end of the outer housing;

a mechanical mechanism generally disposed within the outer housing, said mechanical mechanism including an indexing disk for supporting and rotating said sensor pack, an indexing disk drive arm for rotating said indexing disk, and a knife blade assembly for puncturing said covering and ejecting one of said sensors from said sensor cavity and through said sensor slot; and

a puller handle for moving said indexing disk drive arm and said knife blade assembly, said puller handle being adapted to be grasped between a thumb and a finger of a user hand, said puller handle being adapted to move between a testing position adjacent to the rear end of the outer housing and an extended position spaced outwardly from the rear end of the outer housing in a direction away from the outer housing.

2. The sensor dispensing instrument according to claim 1, wherein said puller handle is moved from the testing position to the extended position to rotate said indexing disk, and is moved from the extended position to the testing position to puncture the covering and eject one of said sensors from said sensor cavity and through said sensor slot.

3. The sensor dispensing instrument according to claim 1, wherein the mechanical mechanism further comprises a moveable disk drive pusher, said indexing disk drive arm and said knife blade assembly being mounted on said disk drive pusher, and said puller handle being affixed to a rear end of said disk drive pusher.

4. The sensor dispensing instrument according to claim 3, wherein the puller handle comprises an upper puller handle and a lower puller handle, said upper puller handle and said lower puller handle being connected together by snap-press fittings that pass through holes formed in the rear end of the disk drive pusher.

5. The sensor dispensing instrument according to claim 3, wherein the puller handle comprises a concave upper surface and a concave lower surface to facilitate gripping by the thumb and finger of the user hand.

6. The sensor dispensing instrument according to claim 3, wherein the puller handle comprises a textured upper surface and a textured lower surface to facilitate gripping by the thumb and finger of the user hand.

7. The sensor dispensing instrument according to claim 1, further comprising an electronics assembly for performing the test and displaying test results, said electronics assembly comprising a printed circuit board, electrical components mounted on the printed circuit board for conducting electronic functions in response to electrical signals, at least one button mounted on the printed circuit board for supplying electrical signals to the electrical components, and a liquid crystal display mounted on the printed circuit board for displaying said test results.

8. The sensor dispensing instrument according to claim 7, wherein the electronics assembly further comprises a communication interface mounted on the printed circuit board for connecting the sensor dispensing instrument to a separate electronic device.

9. The sensor dispensing instrument according to claim 7, wherein the electronics assembly further comprises battery terminals mounted on the printed circuit board for connecting to a battery, said battery for supplying electrical power to said electrical components.

10. The sensor dispensing instrument according to claim 7, wherein said electronics assembly is electrically connected to a sensor actuator disposed adjacent to said sensor slot, said sensor actuator being adapted to connect to contacts on a sensor disposed in said sensor slot and transmit electrical signals between said sensor and said printed circuit board.

11. The sensor dispensing instrument according to claim 1, wherein the puller handle is moveable to a stand-by position, said stand-by position being located between the testing position and the extended position, wherein the puller handle is moved to the stand-by position to release the sensor from the sensor slot.

12. A sensor dispensing instrument adapted to perform a test by using a fluid testing sensor, said fluid testing sensor being supplied by a disposable sensor pack inserted into said sensor dispensing instrument, said sensor pack having a plurality of sensor cavities covered by a protective covering, said fluid testing sensor being enclosed in one of said sensor cavities prior to the performance of said test, said sensor dispensing instrument comprising:

an outer housing having a front end and a rear end, said outer housing further comprising an upper case and a lower case, said upper case and said lower case being pivotally connected together near the rear end of the outer housing in a clam-like fashion to permit the outer housing to be opened to permit the insertion of the sensor pack;

a latch disposed near the front end of the outer housing and adapted to connect the upper case to the lower case so as to close said outer housing after the insertion of said sensor pack;

a sensor slot disposed at the front end of the outer housing, said sensor slot being adapted to receive said fluid testing sensor, said fluid testing sensor projecting outwardly through said sensor slot during the performance of said test;

an indexing disk for supporting and rotating said sensor pack, said indexing disk being rotatably mounted within said outer housing and comprising a plurality of curvilinearly extending grooves and a plurality of radially extending grooves, each radially extending groove being disposed between an adjacent pair of curvilinearly extending grooves;

a disk drive pusher generally disposed within said outer housing for rotating the indexing disk and ejecting the fluid testing sensor from said sensor pack, said disk drive pusher being laterally moveable and comprising an indexing disk drive arm for rotating said indexing disk, said indexing disk drive arm having a cam button that is adapted to engage one of the curvilinearly extending grooves and the radially extending grooves, said disk drive pusher further comprising a knife blade assembly for ejecting the fluid testing sensor from the sensor pack, said knife blade assembly having a knife blade adapted to puncture said protective covering and engage the fluid testing sensor so as to eject said fluid testing sensor from said sensor cavity and through said sensor slot;

a puller handle generally disposed at the rear end of the outer housing for moving said disk drive pusher, said puller handle being affixed to a rear end of the disk drive pusher, said puller handle being adapted to move between a testing position adjacent to the rear end of the outer housing and an extended position spaced outwardly from the rear end of the outer housing in a direction away from the outer housing, said puller handle being adapted to move from the testing position to the extended position to rotate said indexing disk, and wherein said puller handle is moved from the extended position to the testing position to puncture the covering and eject said fluid testing sensor from said sensor cavity and through said sensor slot;

an electronics assembly for performing the test and displaying test results, said electronics assembly comprising a printed circuit board, electrical components mounted on the printed circuit board for conducting electronic functions in response to electrical signals, a plurality of buttons mounted on the printed circuit board for supplying electrical signals to the electrical components, a liquid crystal display mounted on the printed circuit board for displaying said test results; and

a sensor actuator disposed within said outer housing adjacent to said sensor slot for connecting the fluid testing sensor to the electronics assembly, said sensor actuator having metal contacts adapted to connect to contacts on the fluid testing sensor when said fluid sensor testing sensor is disposed in said sensor slot so as to transmit electrical signals between said fluid testing sensor and the printed circuit board of said electronics assembly.

13. The sensor dispensing instrument according to claim 12, wherein the metal contacts of said sensor actuator are connected to the contacts on said fluid testing sensor when said puller handle is in the testing position.

14. The sensor dispensing instrument according to claim 13, wherein the puller handle is moveable to a stand-by position, said stand-by position being located between the testing position and the extended position, the metal contacts of said sensor actuator being disconnected from the contacts on said fluid testing sensor when said puller handle is moved from the testing position to the stand-by position.

15. The sensor dispensing instrument according to claim 12, wherein the puller handle comprises an upper puller handle and a lower puller handle, said upper puller handle and said lower puller handle being connected together by snap-press fittings that pass through holes in the rear end of the disk drive pusher.

16. The sensor dispensing instrument according to claim 12, wherein the puller handle comprises a concave upper surface and a concave lower surface to facilitate gripping by a thumb and a finger of a user hand.

17. The sensor dispensing instrument according to claim 12, wherein the puller handle comprises a textured upper surface and a textured lower surface to facilitate gripping by a thumb and a finger of a user hand.

18. A method of operating a sensor dispensing instrument comprising the acts of:

a) providing a sensor dispensing instrument adapted to handle a sensor pack containing a plurality of sensors and adapted to perform a test using said plurality of sensors, said sensor dispensing instrument comprising said plurality of sensors disposed in a sensor cavity on said sensor pack and enclosed by a protective covering, an outer housing having a sensor slot through which one of said sensors is disposed to conduct the test, said sensor dispensing instrument further comprising a mechanical mechanism having an indexing disk for supporting and rotating said sensor pack, an indexing disk drive arm for rotating said indexing disk, a knife blade assembly for puncturing said covering and ejecting one of said sensors from said sensor cavity and through said sensor slot, and a puller handle for moving said indexing disk drive arm and said knife blade assembly;

b) grasping said puller;

c) pulling said puller handle to an extended position spaced outwardly from the rear end of the outer housing in a direction away from said outer housing to cause said indexing disk drive arm to rotate said indexing disk;

d) pushing said puller handle towards said outer housing to cause said knife blade assembly to puncture the covering and eject one of said sensors from said sensor cavity and through said sensor slot; and

e) performing the test by using the sensor disposed in said sensor slot.

19. The method of operating a sensor dispensing instrument according to claim 18, wherein said covering is a foil covering.

20. A method of operating a sensor dispensing instrument comprising the acts of:

a) providing a sensor dispensing instrument adapted to handle a sensor pack containing a plurality of sensors and adapted to perform a test using said plurality of sensors, said sensor dispensing instrument comprising said plurality of sensors disposed in a sensor cavity on said sensor pack and enclosed by a protective covering, an outer housing having a sensor slot disposed at a front end of the outer housing through which one of said sensors is disposed to conduct the test, and said sensor dispensing instrument further comprising a mechanical mechanism having an indexing disk for supporting and rotating said sensor pack, a moveable disk drive pusher, an indexing disk drive arm mounted on the disk drive pusher for rotating said indexing disk, a knife blade assembly mounted on the disk drive pusher for puncturing said covering and ejecting one of said sensors from said sensor cavity and through said sensor slot, and a puller handle affixed to an end of the disk drive pusher for moving said disk drive pusher, said puller handle being moveable between a testing position adjacent to a rear end of the outer housing and an extended position spaced outwardly from the rear end of the outer housing in a direction away from the outer housing;

b) grasping said puller handle when said puller handle is in the testing position;

c) moving said puller handle from the testing position to the extended position so as to move said disk drive pusher and cause said indexing disk drive arm to rotate said indexing disk;

d) moving said puller handle from the extended position to the testing position so as to move said disk drive pusher and cause said knife blade assembly to puncture the covering and eject one of said sensors from said sensor cavity and through said sensor slot; and

e) performing the test by using the sensor disposed in said sensor slot.

21. The method of operating a sensor dispensing instrument according to claim 20, further comprising the act of removing the sensor from the sensor slot, the act of removing the sensor from the sensor slot being accomplished by moving the puller handle from the testing position to a stand-by position, said stand-by position being located between the testing position and the extended position.

22. The method of operating a sensor dispensing instrument according to claim 21, wherein the stand-by position is located near the testing position.

23. A method of operating a sensor dispensing instrument comprising the acts of:

a) providing a sensor dispensing instrument adapted to handle a sensor pack containing a plurality of sensors and adapted to perform a test using said plurality of sensors, said sensor dispensing instrument comprising said plurality of sensors disposed in a sensor cavity on said sensor pack and enclosed by a protective foil covering, an outer housing having a sensor slot disposed at a front end of the outer housing through which one of said sensors is disposed to conduct the test, and said sensor dispensing instrument further comprising a mechanical mechanism having an indexing disk for supporting and rotating said sensor pack, a moveable disk drive pusher, an indexing disk drive arm mounted on the disk drive pusher for rotating said indexing disk, a knife blade assembly mounted on the, disk drive pusher for puncturing said foil covering and ejecting one of said sensors from said sensor cavity and through said sensor slot, and a puller handle affixed to an end of the disk drive pusher for moving said disk drive pusher, said puller handle being moveable between a testing position adjacent to a rear end of the outer housing, an extended position spaced outwardly from the rear end of the outer housing in a direction away from the outer housing, and a stand-by position located between the testing position and the extended position;

b) grasping said puller handle between a finger and a thumb of a user hand when said puller handle is in the stand-by position;

c) pulling said puller handle from the stand-by position to the extended position so as to move said disk drive pusher and cause said indexing disk drive arm to rotate said indexing disk;

d) pushing said puller handle from the extended position to the testing position so as to move said disk drive pusher and cause said knife blade assembly to puncture the foil covering and eject one of said sensors from said sensor cavity and through said sensor slot;

e) performing the test by using the sensor disposed in said sensor slot; and

f) moving said puller handle from the testing position to the stand-by position so as to cause the sensor to be released from the sensor slot.

24. The method of operating a sensor dispensing instrument according to claim 23, wherein the act of pulling said puller handle from the stand-by position to the extended position also causes an electronics assembly disposed in said outer housing to turn ON, and wherein said electronics assembly is used during the act of performing the test by using the sensor disposed in said sensor slot.