Minimal procedure analyte test system

• US 20030212345A1
• Filed: 05/09/2002
• Published: 11/13/2003
• Est. Priority Date: 05/09/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: McAllister, Devin, Sohrab, Borzu, Olson, Lorin
• Granted Patent: US 7,303,726 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/1518 Security or safety mechanism to be deactivated for forwarding next piercing element
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/15184 Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A system employing an integrated analyte test strip including a biosensor and lancet is disclosed. The integration of lancet and the sensor elements eliminates the need to align the sensor to the biologic fluid sample after a lancet and lancing device are used in combination to pierce the skin. The system preferably includes a device comprising two body portions that slide relative to each other to both cock and fire a test strip at a target site. Meter reading and test strip disposal may be accomplished by removing the device from the target site. The device preferably employs a magazine loaded with test strips, with one strip being taken from the magazine each time the device is actuated. It preferably also includes a magazine in a cap to store spent test strips for disposal. The device may be turned on an off simply by removal and return of the cap.

Claims

1. An analyte detection system comprising:

a first body portion and a second body portion, said second body portion slidably received by said first body portion, a magazine adapted to receive a plurality of unused test strip members and a test strip interface member,

wherein said body portions are adapted so compressive movement between each advances said interface member to take a test strip from said magazine and pass at least a lance portion of said test strip past a face of said second body portion to penetrate a tissue site.

2. The system of claim 1, wherein said magazine is carried by said second body portion and said adaptation comprises a lever carried by said first body portion, said lever having a first end and a second end, wherein said first end is actuated by said second body portion to cock a spring between said second end and said interface member for firing a test strip member.

3. The system of claim 1, further comprising a button, wherein said body portions are adapted to be moveable relative to each other upon depressing said button.

4. The system of claim 1, further comprising a meter test element and a meter screen.

5. The system of claim 1, further comprising a test strip disposal mechanism including a pusher arm with a disposal interface portion, a lever arm, and an intermediate link between said arm and said disposal interface portion.

6. The system of claim 5, wherein said disposal mechanism is adapted to be actuated manually by an extension from said lever arm.

7. The system of claim 5, wherein said disposal mechanism is adapted to be actuated by an interface portion of a cap.

8. The system of claim 1, further comprising a cap.

9. The system of claim 8, wherein said cap carries a magazine adapted to receive a plurality of used test strip members.

10. The system of claim 9, further comprising a test strip disposal mechanism adapted to deposit used test strips in said magazine.

11. The system of claim 10, wherein said a test strip disposal mechanism includes a pusher arm with a disposal interface portion, a lever arm, and an intermediate link between said arm and said disposal interface portion.

12. The system of claim 11, wherein said disposal mechanism is adapted to be actuated by an interface portion of said cap.

13. The system of claim 1, further comprising a plurality of test strip members, each comprising a sensor and at least one forward-facing lance member.

14. The system of claim 13, wherein said plurality of test strip members are provided in a cartridge.

15. The system of claim 13, wherein unused test strip members are sealed behind a door.

16. A method of testing for analyte concentration in a biological sample comprising:

providing a system as described in claim 13,

placing said second body portion face against a test site,

forcing said body portions toward each other to cock and fire a test strip member,

removing said system from the test site; and

displaying results on a meter screen.

17. The method of claim 16, further comprising:

storing said test strip in a magazine after use.

18. The method of claim 17, wherein said system further comprises a cap and replacing said cap once removed results in said storing.

19. The method of claim 16, wherein said system further comprises a cap, said method further comprising:

removing said cap to turn on said system.

20. The method of claim 19, further comprising:

replacing said cap to turn off said system.

21. The method of claim 16, further comprising:

ejecting said test strip member after use.

22. The method of claim 16, wherein said test strip is ejected by manually actuating a lever arm extension.

23. The method of claim 16, wherein said plurality of test strip members are provided in a cartridge and information regarding test strips associated with said cartridge is read by said system.