Integrated lancet and analyte testing apparatus

• US 9,060,726 B2
• Filed: 09/18/2012
• Issued: 06/23/2015
• Est. Priority Date: 10/03/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Rush, Benjamin M., Feldman, Benjamin J.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/622,238
• Publication Number:
  US 20130066179A1
• Time in Patent Office: 1,008 Days
• Field of Search: 204/403.01, 600/583, 600/584, 606/181, 606/182, 606/183, 606/185
• US Class Current: 1/1
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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

Abstract

Integrated lancing and analyte measurement systems are provided which minimize the number of actions required to operate the systems, accomplished in part by combining two or more user steps into one.

Claims

1. A method of using an integrated analyte measurement system, the method comprising:

pulling a lever in an arming direction to advance a test strip in a test strip advancing direction, the test strip advancing through a first aperture in an exterior housing of the analyte measurement system and to also arm a lancet positioned within the exterior housing, the lancet for firing through a second aperture in the exterior housing, wherein the housing comprises a first end and a second end opposite the first end, wherein the second aperture is spaced apart from the first aperture on the exterior housing, and wherein the first aperture is in the first end of the housing and the lever is at the second end of the housing; and

pressing a button within the housing to fire the lancet in a lancing direction which is parallel to the arming direction and the test strip advancing direction, the lancet firing through the second aperture on the exterior housing into the skin.

2. The method of claim 1, further comprising contacting an exposed end of the test strip with body fluid extracted from the skin and measuring an analyte level within the body fluid using electronics within the housing.

3. The method of claim 1, further comprising moving a switch within the housing to rearm the lancet without advancing a test strip.

4. The method of claim 1, further comprising containing a plurality of test strips within the housing in a hermetically sealable condition, wherein pulling the lever momentarily unseals the test strips.

5. The method of claim 1, further comprising selectively adjusting a height of a skin-contacting structure extending on the housing at the first aperture.

6. The method of claim 1, wherein the method further comprises, prior to pushing the button, pushing the lever in a direction which is opposite the arming direction.

7. The method of claim 1, wherein a portion of the exterior housing lies between the first and second apertures.

8. The method of claim 1, wherein the exterior housing comprises an internal surface and an external surface and the first and second apertures open from the internal surface to the external surface.

9. The method of claim 1, wherein the test strip is advanced through the first aperture in a first direction, and wherein the lancet is fired through the second aperture in the first direction.

10. The method of claim 1, wherein the test strip protrudes out of the exterior housing when then lancet is fired through the second aperture.

11. The method of claim 1, wherein pulling of the lever to advance a test strip through the first aperture comprises pulling the lever in a first direction along a single axis of motion and thereby advancing the test strip in a second direction which is opposite the first direction.

12. The method of claim 1, wherein the analyte measurement system comprises a pusher within the exterior housing and where pulling the lever to advance the test strip through the first aperture comprises advancing the pusher in an arcuate manner within the exterior housing.

13. The method of claim 1, wherein pressing the button to fire the lancet through the second aperture causes the lancet to fire into the skin at a skin site location;

and wherein the method further comprises, after pressing the button to fire the lancet through the second aperture, re-positioning the analyte measurement system to contact the test strip with the skin site location.

14. The method of claim 1, wherein the exterior housing comprises an adjustable expression cap for retaining the lancet therein, and wherein the method further comprises, prior to pressing a button within the housing to fire the lancet through the second aperture, retaining the lancet within the expression cap.

15. The method of claim 1, wherein pulling the lever comprises pulling an end of the lever in the arming direction, wherein the arming direction is linear and is away from the exterior housing.

16. The method of claim 1, wherein the arming direction is opposite the test strip advancing direction.

17. The method of claim 1, wherein pulling the lever in the arming direction comprises pulling the lever along a single axis of motion which is defined by the first end and the second end of the housing and which is parallel to the lancing direction and the test strip advancing direction.