SINGLE-USE LANCET SENSOR ASSEMBLY AND METER

• US 20100036407A1
• Filed: 08/07/2008
• Published: 02/11/2010
• Est. Priority Date: 08/07/2008
• Status: Active Grant

• Current Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Fowler, James, Daggett, Robert
• Granted Patent: US 8,449,480 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/15019 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15148 Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
• 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
• CPC Class Codes: A61B 90/96 : using barcodes

Abstract

A single-use lancet cartridge for inserting into a multi-use lancet driver assembly includes an elongated lancet housing with an open end, a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end, and a re-use prevention component incorporated within the lancet cartridge and oriented to cooperatively engage with a driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time. The single-use lancet cartridge is used that contains the multi-use lancet driver assembly.

Claims

1. A single-use lancet cartridge for inserting into a multi-use lancet driver assembly, the single-use lancet cartridge comprising:

an elongated lancet housing with an open end;

a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end; and

a re-use prevention component incorporated within the lancet cartridge and oriented to cooperatively engage with a driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time.

2. The single-use lancet cartridge of claim 1 wherein the re-use prevention component is a removable, elongated cocking tab with at least one driver piston engageable surface wherein the cocking tab is removed from the single-use lancet cartridge after engaging the driver piston into a cocked orientation.

3. The single-use lancet cartridge of claim 2 wherein the elongated cocking tab has a second driver piston engageable surface.

4. The single-use lancet cartridge of claim 2 wherein the cocking tab is operably connected to a needle safety cap, which is covering a needle of the lancet.

5. The single-use lancet cartridge of claim 1 wherein the re-use prevention component is a rotatable drive wing having a first drive wing portion and a second drive wing portion connected to a lancet body of the lancet with the first drive wing portion extending out through a first elongated side opening of the lancet housing to present a driver piston engageable surface for cooperative engagement with the driver piston wherein the rotatable wing rotates into the first elongated side opening of the lancet housing after the lancet is moved into a piercing orientation by the drive piston thereby preventing the rotatable wing from subsequently presenting the driver piston engageable surface to the driver piston.

6. The single use lancet cartridge of claim 5 further comprising an anti-rotation wing stop cooperatively engageable with the second drive wing portion.

7. The single-use lancet cartridge of claim 1 further comprising a test strip integrally connected to the elongated lancet housing.

8. A lancet system with safety feature, the system comprising:

a multi-use lancet driver assembly having a driver piston, the multi-use lancet driver assembly contained within a meter housing; and

a single-use lancet cartridge having a lancet housing with an open end, a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end, and a re-use prevention component incorporated within the lancet cartridge and oriented to cooperatively engage with the driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time.

9. The lancet system of claim 8 wherein the re-use prevention component is a removable, elongated cocking tab with at least one driver piston engageable surface wherein the cocking tab is removed from the single-use lancet cartridge after engaging the driver piston into a cocked orientation.

10. The lancet system of claim 9 wherein the elongated cocking tab has a second driver piston engageable surface.

11. The lancet system of claim 9 wherein the cocking tab is operably connected to a needle safety cap, which is covering a needle of the lancet.

12. The lancet system of claim 8 wherein the re-use prevention component is a rotatable drive wing having a first drive wing portion and a second drive wing portion connected to a lancet body of the lancet with the first drive wing portion extending out through a first elongated side opening of the lancet housing to present a driver piston engageable surface for cooperative engagement with the driver piston wherein the rotatable wing rotates into the first elongated side opening of the lancet housing after the lancet is moved into a piercing orientation by the drive piston thereby preventing the rotatable wing from subsequently presenting the driver piston engageable surface to the driver piston.

13. The lancet system of claim 12 further comprising an anti-rotation wing stop cooperatively engageable with the second drive wing portion.

14. The lancet system of claim 12 wherein the drive piston includes a deflectable drive wing pawl extending beyond the end of the drive piston, the deflectable drive wing pawl having a wing rotating surface engageable with the rotatable drive wing after the lancet is moved into a piercing orientation by the drive piston thereby causing the rotatable wing to rotate into the first elongated side opening.

15. The lancet system of claim 8 further comprising a lancet cartridge lock within the system enclosure, the lancet cartridge lock having an elongated and biasing member with a locking tab extending laterally from the biasing member and situated for cooperative and biasing engagement with a notch in the bottom of the lancet housing when a lancet cartridge is inserted into a lancet cartridge receiving port of the system enclosure.

16. The lancet system of claim 15 further comprising a cartridge ejector having an ejector body with a cartridge engaging member having a tab engaging surface and a lancet cartridge ejector surface situated within the meter housing, and an ejector button laterally and integrally connected to the ejector body and disposed outside of the meter housing for slidably ejecting the lancet cartridge wherein the tab engaging surface is positioned to engage the locking tab before the lancet cartridge ejector surface engages the lancet cartridge when the ejector button is slidably engaged.

17. The lancet system of claim 8 further comprising a piston arming component having an arming member body and a cocking button laterally and integrally connected to the arming member body, the cocking button being disposed outside of the meter housing for slidably moving the driver piston into a armed orientation.

18. The lancet system of claim 17 further comprising a piercing depth control having an arcuate surface with a variable radius relative to the piercing depth control axis that engages a piercing depth end of the arming member body situated within the meter housing and an outer surface a portion of which extends outside of the meter housing for setting the position of the arcuate surface relative to the piercing depth end of the arming member body.

19. The lancet system of claim 8 further comprising a scanner module housed within the system enclosure and electronically coupled to the electronic measuring module.

20. The lancet system of claim 8 wherein the lancet driver assembly further includes an actuator button cooperatively connected to the driver piston when the driver piston is in a cocked orientation.