Dynamic integrated lancing test strip with sterility cover

• US 20060200045A1
• Filed: 03/02/2005
• Published: 09/07/2006
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Granted Patent: US 7,815,579 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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, and

a sterility sheet covering the packet to maintain sterility of the incision forming member and prevent cross-contamination between the test strip and the incision forming member, wherein the sterility sheet allows the incision forming member to be sterilized separately from 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 the sterility sheet to engage the engagement opening of the lancet, 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, further comprising:

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; and

wherein the sterility sheet is folded to form two flaps with a crease in between that encloses the guide slot opening and the guide member is sandwiched between the flaps to enclose the guide slot.

8. 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.

9. The apparatus of claim 1, wherein:

the incision forming member includes a lancet; and

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

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

11. The apparatus of claim 1, further comprising:

means for analyzing the body fluid, wherein the means for analyzing the body fluid includes the test strip;

means for forming the incision, wherein the means for forming the incision includes the incision forming member; and

means for maintaining sterility of the incision forming member, wherein the means for maintaining sterility of the incision forming member includes the sterility sheet.

12. A method, comprising:

creating a lancet packet by enclosing a lancet in a sterility sheet to form a sterile enclosure;

sterilizing the lancet; and

assembling an integrated lancing test strip by attaching the lancet packet to a test strip after said sterilizing the lancet.

13. The method of claim 12, wherein said sterilizing occurs after said creating the lancet packet.

14. The method of claim 12, wherein said sterilizing occurs before said creating the lancet packet.

15. The method of claim 12, wherein:

said creating the lancet packet includes

providing a belt that includes a plurality of the lancets, and

sandwiching the belt between the sterility sheet by the folding the sterility sheet around the belt.

16. The method of claim 15, further comprising cutting the integrated lancing test strip from the belt.

17. The method of claim 12, further comprising:

creating an engagement opening in the lancet;

creating a relief notch in the test strip; and

wherein said assembling the integrated lancing test strip includes aligning the engagement opening of the lancet with the relief notch of the test strip.

18. A meter, comprising:

a holder configured to hold a test strip; and

an adjustment mechanism cooperating with the holder to position the test strip relative to a tissue with an incision for reducing pressure applied against the tissue in order to minimize flow constriction of body fluid from the incision as the body fluid is collected with the test strip.

19. The meter of claim 18, further comprising:

the test strip;

a lancet coupled to the test strip to form an integrated lancing test strip;

a firing mechanism coupled to the holder for firing the lancet towards the tissue and for retracting the lancet from the incision.

20. The meter of claim 19, wherein the adjustment mechanism includes:

a connector coupled to one end of the test strip distal from the tissue, wherein the connector is slidably disposed relative to the holder; and

a stop member that is moveable relative to the connector to adjust distance between the stop member and the connector, wherein the stop member is positioned to limit travel of the connector during retraction of the lancet.

21. The meter of claim 19, further comprising:

the integrated lancing test strip including a sterility sheet that encloses the lancet to maintain sterility of the lancet;

the lancet defining an engagement opening;

a connector coupled to one end of the test strip;

a cam arm pivotally coupled to the holder, wherein the cam arm includes a cam portion and a blade configured to pierce the sterility sheet; and

the connector being slidable relative to the holder to contact the cam portion and to rotate the pivot arm in order for the blade of the cam arm to pierce the sterility sheet and engage with the engagement opening in the lancet during loading of the integrated lancing test strip.

22. The meter of claim 18, further comprising a connector connecting the firing mechanism to the holder in a side-by-side orientation for compactly packaging the firing mechanism and the holder.

23. The meter of claim 18, further comprising:

a housing in which the holder is disposed;

a cap coupled to the housing; and

a expression member threadedly coupled to the cap to allow the expression member to move relative to the cap in a telescoping manner, wherein the expression member defines a sample opening through which the test strip samples the body fluid.

24. The meter of claim 18, further comprising:

means for holding the test strip; and

means for positioning the test strip relative to the tissue.