Dynamic integrated lancing test strip with sterility cover

• US 9,445,756 B2
• Filed: 09/22/2010
• Issued: 09/20/2016
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US12/887,612
• Publication Number:
  US 20110009775A1
• Time in Patent Office: 2,190 Days
• Field of Search: 600/583, 600/584, 600/576, 422/22, 422/40, 606/181, 606/183
• US Class Current: 1/1
• 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 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150312 Sterilisation of piercing elements, piercing devices or sampling devices piercing element stocking means, e.g. cartridges, A61B5/15176
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• 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 5/15194 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

An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Claims

1. An apparatus, comprising:

a test strip adapted to analyze body fluid; and

a packet coupled to the test strip, wherein the packet includes

an incision forming member to form an incision in tissue,

a guide member with a guide slot in which the incision forming member is slidably disposed, wherein the guide slot defines a guide slot opening through which the incision forming member extends during lancing, the guide member having opposing sides and an end edge located between the opposing sides, wherein the guide slot opens at the opposing sides of the guide member, wherein the guide slot opening opens at the end edge of the guide member, and

a sterility sheet having a top layer and a bottom layer, the top layer being sealed over a top surface of the guide member, and the bottom layer being sealed over a bottom surface of the guide member to enclose the incision forming member in the guide slot, wherein the top layer and the bottom layer of the sterility sheet cover the guide slot at the opposing sides and the guide slot opening, wherein at least one of the top layer or the bottom layer of the sterility sheet seals the guide slot opening and the guide slot of the guide member to maintain sterility of the incision forming member, wherein one of the top layer or the bottom layer of the sterility sheet is positioned between the incision forming member and the test strip.

2. The apparatus of claim 1, wherein the incision forming member defines an engagement opening for engaging the incision forming member during lancing.

3. The apparatus of claim 2, further comprising:

a meter including

a cam arm with a blade that pierces one of the top layer or the bottom layer of the sterility sheet to engage the engagement opening of the incision forming member, and

a firing mechanism coupled to the cam arm for firing the incision forming member.

4. The apparatus of claim 3, wherein the meter includes an adjustment mechanism to adjust position of the test strip relative to the tissue during sampling for minimizing flow constriction of the body fluid from the incision.

5. The apparatus of claim 3, wherein the test strip defines a relief opening that is aligned with the engagement opening for allowing the blade to extend completely through the engagement opening in the incision forming member.

6. The apparatus of claim 2, wherein the test strip defines a relief opening that is aligned with the engagement opening.

7. The apparatus of claim 1, wherein the test strip defines a capillary opening in which the body fluid is drawn and a notch positioned proximal the packet to direct flow of the body fluid away from the incision forming member.

8. The apparatus of claim 1, wherein:

the incision forming member includes a lancet; and

both the packet and test strip are flat to permit compact packaging.

9. The apparatus of claim 1, wherein the sterility sheet is hydrophobic for wiping the body fluid from the incision forming member during retraction.

10. The apparatus of claim 1, wherein the opposing sides of the guide member are flat.

11. The apparatus of claim 1, wherein the guide member has end stops inwardly extending at the guide slot opening of the guide slot.

12. The apparatus of claim 1, wherein the guide member has a body portion with one or more stop edges that are wider than the guide slot opening.

13. The apparatus of claim 12, wherein the incision forming member has a neck portion smaller than the guide slot opening extending from the body portion, wherein the neck portion is configured to be received between the one or more stop edges such that the one or more stop edges can limit rotation of the incision forming member during lancing, wherein the incision forming member has a tip extending from the neck portion configured to cut tissue.

14. The apparatus of claim 1, wherein the test strip is attached to the sterility sheet, wherein the sterility sheet is sandwiched between the test strip and the packet.

15. The apparatus of claim 1, wherein the test strip has a flat rectangular shape.

16. The apparatus of claim 1, wherein the incision forming member and the guide member are connected together via breakable tabs.

17. An apparatus, comprising:

a test strip configured to analyze body fluid;

a lancet packet attached to the test strip;

a lancet sealed inside the lancet packet to maintain sterility of the lancet, wherein the lancet packet includes a sheet having a first layer and a second layer sealed around the lancet, the first layer of the sheet is positioned between the test strip and the lancet, the lancet having an engagement opening;

a firing mechanism configured to fire the lancet, the firing mechanism having a blade piercing the lancet packet, the blade engaging the engagement opening of the lancet;

wherein the test strip defines a relief opening that is aligned with the engagement opening; and

wherein at least part of the blade of the firing mechanism extends into the relief opening of the test strip.

18. The apparatus of claim 17, further comprising:

a guide member with a guide slot in which the lancet is slidably disposed.

19. The apparatus of claim 18, wherein the guide slot has one or more end stops to retain the lancet in the lancet packet.

20. The apparatus of claim 17, wherein:

the test strip has a capillary channel opening where the body fluid enters the test strip; and

the lancet packet is located on the test strip at a position where the lancet extends proximal the capillary channel opening.

21. The apparatus of claim 17, wherein:

the test strip has a capillary channel opening;

the lancet packet has an end edge where the lancet pierces the lancet packet during lancing; and

the end edge of the lancet packet is recessed away from the capillary channel opening to promote flow of the body fluid to the capillary channel opening.

22. The apparatus of claim 17, wherein the test strip has a notch positioned proximal the lancet packet to direct flow of the body fluid away from the lancet packet.

23. The apparatus of claim 17, wherein the test strip is an electrochemical test strip.

24. The apparatus of claim 17, wherein at least a portion of the lancet packet is hydrophobic.

25. An apparatus, comprising:

a test strip adapted to analyze body fluid; and

a packet coupled to the test strip, wherein the packet includes

an incision forming member to form an incision in tissue,

a guide member with a guide slot in which the incision forming member is slidably disposed, the guide member having opposing sides and an end edge located between the opposing sides, wherein the guide slot opens at opposing sides of the guide member, wherein the guide slot defines a guide slot opening at the end edge of the guide member through which the incision forming member extends during lancing, and

a single sterility sheet having two flaps, the two flaps being sealed and wrapped around the guide member and the incision forming member to cover the incision forming member and the guide slot, wherein the two flaps of the single sterility sheet seal and cover the guide slot opening and the guide slot of the guide member to maintain sterility of the incision forming member, wherein one of the two flaps is positioned between the guide member and the test strip.