Dynamic integrated lancing test strip with sterility cover

• US 9,034,250 B2
• Filed: 09/16/2010
• Issued: 05/19/2015
• Est. Priority Date: 03/02/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US12/883,545
• Publication Number:
  US 20110000168A1
• Time in Patent Office: 1,706 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 600/181, 606/181
• US Class Current: 422/22
• 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. A method, comprising:

creating a lancet packet by enclosing a plurality of lancets in a sterility sheet to form a sterile enclosure, wherein said creating the lancet packet includes

providing a belt having a length extending in a direction, the belt including a plurality of the lancets, and

sandwiching the belt between the sterility sheet by folding the sterility sheet around the belt, wherein said sandwiching includes positioning the sterility sheet with a fold that extends in the direction of the length of the belt, wherein the fold is located between two flaps of the sterility sheet;

sterilizing one of the lancets; and

assembling an integrated lancing test strip by attaching the lancet packet to a test strip after said sterilizing the lancet, wherein the two flaps of the sterility sheet are sealed on opposing sides of the belt.

2. The method of claim 1, wherein said sterilizing occurs after said creating the lancet packet.

3. The method of claim 1, wherein said sterilizing occurs before said creating the lancet packet.

4. The method of claim 1, further comprising cutting the integrated lancing test strip from the belt.

5. The method of claim 1, 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.

6. The method of claim 1, wherein said creating the lancet packet includes:

locating the lancet inside a guide slot of a guide member, wherein the guide slot has a guide slot opening,

folding the sterility sheet to form the two flaps with the crease in between, and

enclosing the guide slot of the guide member by sandwiching the guide member between the flaps.

7. The method of claim 1, further comprising:

creating a capillary opening in the test strip in which body fluid is drawn; and

positioning a notch in the test strip proximal the lancet packet to direct flow of the body fluid away from the lancet.

8. The method of claim 1, wherein:

both the lancet packet and the test strip are generally flat; and

said assembling the integrated lancing test strip includes sandwiching the lancet packet and the test strip together to create a compact configuration.

9. The method of claim 1, further comprising treating the sterility sheet so that at least a part of the sterility sheet is hydrophobic.

10. The method of claim 1, further comprising:

creating a guide member with a guide slot that has one or more end stops to retain the lancet in the lancet packet; and

sealing the guide member in the lancet packet with the lancet disposed inside the guide slot.

11. The method of claim 1, further comprising:

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

wherein said assembling the integrated lancing test strip includes locating the test strip at a position where the lancet extends proximal the capillary channel opening.

12. The method of claim 11,

wherein the packet has an end edge where the lancet pierces the packet;

and

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

13. The method of claim 1, wherein the test strip is an electrochemical test strip.

14. The method of claim 1, further comprising:

treating the sterility sheet so that at least a part of the sterility sheet is hydrophobic;

wherein said sterilizing occurs after said creating the lancet packet;

wherein said creating the lancet packet includes

locating the lancet inside a guide slot of a guide member, wherein the guide slot has a guide slot opening and one or more end stops to retain the lancet in the lancet packet,

locating the test strip at a position where the lancet extends proximal a capillary channel opening of the test strip,

wherein said sandwiching the belt between the sterility sheet by folding the sterility sheet around the belt includes forming two flaps with a crease in between,

enclosing the guide slot of the guide member by sandwiching the guide member between the flaps, and

cutting the integrated lancing test strip from the belt;

creating a capillary opening in the test strip in which body fluid is drawn;

positioning a notch in the test strip proximal the lancet packet to direct flow of the body fluid away from the lancet;

wherein both the lancet packet and the test strip are generally flat;

wherein the packet has an end edge where the lancet pierces the packet;

positioning the end edge of the packet is recessed away from the capillary channel opening to promote flow of the body fluid to the capillary channel opening; and

wherein the test strip is an electrochemical test strip.

15. The method of claim 1,

wherein the sterility sheet is a continuous band;

further comprising rolling the continuous band of the sterility sheet off a reel before said sandwiching; and

rolling the belt of lancets off a reel before said sandwiching.

16. The method of claim 1,

wherein said assembling the integrated lancing test strip includes manufacturing in a continuous process to form a contiguous strip having multiple integrated lancing test strips;

and further comprising

rolling the strip of integrated lancing test strips around a reel in a cassette.

17. The method of claim 1, wherein said sterilizing includes sterilizing the lancet packet with radiation after said creating the lancet packet.

18. A method, comprising:

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

sterilizing the lancet;

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

wherein both the lancet packet and the test strip are generally flat;

wherein said assembling the integrated lancing test strip includes sandwiching the lancet packet and the test strip together to create a compact configuration; and

wherein said assembling includes folding the sterility sheet in a continuous manner in which the sterility sheet forms two flaps with a crease in between and sealing the flaps on opposing sides of the lancet.

19. The method of claim 18, wherein said creating the lancet packet includes:

locating the lancet inside a guide slot of a guide member, wherein the guide slot has a guide slot opening,

folding the sterility sheet to form two flaps with a crease in between, and

enclosing the guide slot of the guide member by sandwiching the guide member between the flaps.

20. The method of claim 18, 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.

21. The method of claim 18, further comprising:

creating a capillary opening in the test strip in which body fluid is drawn; and

positioning a notch in the test strip proximal the lancet packet to direct flow of the body fluid away from the lancet.

22. The method of claim 18, further comprising treating the sterility sheet so that at least a part of the sterility sheet is hydrophobic.

23. The method of claim 18, further comprising:

creating a guide member with a guide slot that has one or more end stops to retain the lancet in the lancet packet; and

sealing the guide member in the lancet packet with the lancet disposed inside the guide slot.

24. The method of claim 18, further comprising:

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

wherein said assembling the integrated lancing test strip includes locating the test strip at a position where the lancet extends proximal the capillary channel opening.

25. The method of claim 24,

wherein the packet has an end edge where the lancet pierces the packet;

and further comprising

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

26. The method of claim 18, wherein said sterilizing includes sterilizing the lancet packet with radiation after said creating the lancet packet.

27. A method, comprising:

creating a lancet packet by enclosing a lancet in a sterility sheet to form a sterile enclosure, wherein said creating the lancet packet includes;

locating the lancet inside a guide slot of a guide member, wherein the guide slot has a guide slot opening,

folding the sterility sheet to form two flaps with a crease in between, and

enclosing the guide slot of the guide member by sandwiching the guide member between the flaps, wherein said enclosing includes sealing the two flaps against opposing sides of the guide member and sealing the guide slot opening with the crease;

sterilizing the lancet; and

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

28. The method of claim 27, 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.

29. The method of claim 28, further comprising:

creating a capillary opening in the test strip in which body fluid is drawn; and

positioning a notch in the test strip proximal the lancet packet to direct flow of the body fluid away from the lancet.

30. The method of claim 27, further comprising treating the sterility sheet so that at least a part of the sterility sheet is hydrophobic.

31. The method of claim 27, further comprising:

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

wherein said assembling the integrated lancing test strip includes locating the test strip at a position where the lancet extends proximal the capillary channel opening.

32. The method of claim 31,

wherein the packet has an end edge where the lancet pierces the packet;

and further comprising

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