Continuous strip of fluid sampling and testing devices and methods of making, packaging and using the same

• US 20030211619A1
• Filed: 05/09/2002
• Published: 11/13/2003
• Est. Priority Date: 05/09/2002
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: McAllister, Devin, Olson, Lorin
• Application Number:
  US10/142,409
• Publication Number:
  US 20030211619A1
• Time in Patent Office: Days
• US Class Current: 436/44
• 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 5/150213 Venting means
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: Y10T 436/110833 : Utilizing a moving indicator strip or tape

Abstract

The present invention provides continuous strips of testers in an individually-sealed water-impermeable packaging which maintains the testers in a sterile condition until used. The subject testers include a test strip sensor integrated with a microneedle for accessing and collecting a sample of physiological fluid and for measuring a chemical characteristic, such as target analyte concentration, of the sampled fluid. The present invention further provides cassettes of the subject strips for removable engagement with a meter for individually dispensing the testers and for facilitating the analysis of the sampled fluid. Also provided by the present invention are systems which include the subject strips and cassettes and such a meter. Methods of using the strips and cassettes are also provided, along with kits for practicing the subject methods.

Claims

1. A packaging for containing testers for accessing, collecting and analyzing a sample of fluid, comprising:

a first strip portion having a length dimension and a width dimension and comprising a plurality of serially aligned recesses, each said recess comprising an opening for receiving a tester therein and configured for containing said tester therein;

a second strip portion having length and width dimensions similar to said length and said width dimensions of said first strip portion, wherein said second strip portion is aligned with said first strip portion wherein said second strip portion covers said opening of each said recess; and

means for retaining a tester with a corresponding recess.

2. The packaging of claim 1 wherein said first strip portion comprises a plastic material.

3. The packaging of claim 2 wherein said plastic material is a high-density polyethylene.

4. The packaging of claim 3 further comprises an external surface formed of aluminum foil-plastic laminate integrally bonded to said high-density polyethylene.

5. The packaging of claim 1 wherein said first strip portion is bendable between adjacent recesses about an axis along the width of said first strip portion.

6. The packaging of claim 1 said first strip portion further comprises a planar perimeter about said opening of each said recess, wherein said second said strip portion contacts said planar perimeter.

7. The packaging of claim 1 further comprising a plurality of serially aligned holes along the length of said packaging and through said first strip portion and said second strip portion.

8. A method of packaging testers for accessing, collecting and analyzing a sample of fluid, comprising the steps of:

providing a plurality of testers to be packaged;

providing the packaging of claim 1;

associating each of said plurality of testers at the opening of a recess of said first strip portion;

attaching said plurality of testers to said first strip portion; and

sealing said second strip portion to said first strip portion wherein said testers are sealed within said associated recess.

9. The method of claim 8 wherein said plurality of testers are singulated from each other and said step of associating comprises placing each of said plurality of testers within a recess through said opening.

10. The method of claim 9 wherein said step of attaching comprises attaching a proximal end of a tester within the recess.

11. The method of claim 10 wherein said step of attaching a proximal end comprises sonically welding said proximal end to said recess.

12. The method of claim 10 wherein said step of attaching a proximal end comprises using an adhesive material.

13. The method of claim 8 wherein said plurality of testers are interconnected to each other in an end-to-end arrangement and said step of associating comprises aligning said interconnected plurality of testers over said first strip portion wherein each of said plurality of testers is aligned with the opening of a recess.

14. The method of claim 8 further comprising the step of placing a desiccant material with each said recess prior to the step of sealing.

15. The method of claim 8 further comprising the step of forming at least one plurality of serially aligned holes along the length of said sealed packaging.

16. The method of claim 8 further comprising the step of loading said plurality of packaged testers into a cassette.

17. A strip of testers for accessing, collecting and analyzing a sample of fluid, comprising:

a recess portion comprising a plurality of serially aligned recesses;

a tester permanently associated with each said recess; and

a cover portion aligned with and sealed to said first strip, wherein each said tester is hermetically sealed within said associated recess.

18. The strip of claim 17 further comprising at least one plurality of serially aligned holes along the length of said strip.

19. The strip of claim 17 further comprising a desiccant material within each recess.

25. A method of dispensing testers from a strip of testers for accessing and collecting fluid from a target skin surface, comprising the steps of:

(a) providing the strip of claim 17;

(b) separating said recess portion from said cover portion, wherein only a single tester is exposed from an associated recess;

(c) operatively orienting said tester with respect to said target skin surface;

(d) using said tester; and

(d) repositioning said used tester within said associated recess.

26. The method of claim 25 further comprising repeating steps (b) through (e) with a second tester.

27. The method of claim 25 wherein said step (c) comprises the step of separating said recessed strip portion from said tester no less than about 45°

.

28. The method of claim 26 wherein said step of operatively orienting said second tester occurs concurrently with said step repositioning of said used tester.

35. A method of dispensing testers for accessing and collecting fluid from a target skin surface, comprising the steps of:

(a) providing said strip of claim 17;

(b) providing said cassette of claim 20;

(c) operatively loading said strip within said at least one track;

(d) indexing said strip towards said tester dispensing space;

(e) separating said recessed portion of said strip from said cover portion of said strip;

(f) dispensing a first tester through said tester dispensing space;

(f) using said first tester; and

(g) repositioning said first tester within said associated recess.

36. The method of claim 35 further comprising repeating steps (d) through (g) for a second tester.

37. The method of claim 36 wherein said step of dispensing said second tester occurs concurrently with said step of repositioning of said first tester.

38. The method of claim 35 wherein said step of dispensing comprises orienting said tester substantially normal to said target skin surface.

20. A cassette for operatively containing and dispensing testers for accessing, collecting and analyzing a sample of fluid, said cassette comprising:

a housing;

at least one track defined within said housing for storing and guiding a strip of testers when loaded within said cassette;

a pair of drive rollers for indexing said strip of testers; and

a tester dispensing space defined between said pair of drive rollers wherein only a single tester is dispensable through said tester dispensing port at a time.

21. The cassette of claim 20 further comprising a drive gear mechanism positioned on the outside of said housing and operatively connected to at least one of said drive rollers, wherein said drive gear rotates said at least one roller upon activation of said drive gear.

22. The cassette of claim 20 further comprising an area within said housing for storing dispensed testers.

23. The cassette of claim 20 wherein said testers are packaged between a first strip portion and a second strip portion and wherein said at least one track comprises a first track for storing and guiding said strip of testers prior to said testers being dispensed, a second track for storing and guiding said first strip portion and said testers after said testers are dispensed, and a third track for storing and guiding said second strip portion after said testers are dispensed.

24. A system for accessing and collecting a sample of physiological fluid and for measuring the concentration of a target analyte within said fluid, said system comprising:

a cassette according to claim 20;

and

a meter comprising;

(i) a housing having a receptacle for receive said cassette therein and having a distal face having a slot aligned with said tester dispensing space; and

(ii) means for activating said drive gear mechanism of said cassette.

43. A kit for accessing, collecting and analyzing a sample of fluid, comprising:

at least one strip of claim 29;

at least one cassette of claim 20 for dispensing the testers of said strip.

44. The kit of claim 43 further comprising a meter for use with said cassette.

45. The kit of claim 44 further comprising instructions for using said cassette with said meter.

29. A strip of testers for accessing, collecting and analyzing a sample of physiological fluid, comprising:

a frame structure having a length;

a plurality of testers flexibly attached to said frame structure wherein said testers are serially aligned along said length.

30. The strip of claim 29 wherein said testers are formed of a plurality of layers of material and said frame structure is formed from one of said plurality of layers.

31. The strip of claim 29 wherein said frame structure is flexible.

32. The strip of claim 29 wherein said strip is sealed within a packaging material.

33. The strip of claim 32 wherein said packaging material is flexible.

34. The strip of claim 29 wherein said strip defines a plane and said testers are flexible relative to said frame structure.

39. A method of dispensing testers for accessing and collecting fluid from a target skin surface, comprising the steps of:

(a) providing said strip of claim 29;

(b) positioning a tester relative to said frame structure wherein said tester is positioned substantially normal to said target skin surface; and

(c) using said tester to access and collect a sample of said fluid.

40. The method of claim 39 further comprising the step of (d) repositioning said used tester relative to said frame structure.

41. The method of claim 40 further comprising repeating steps (b), (c) and (d) for a second tester wherein said step of repositioning said used tester and said step of positioning said second tester occur simultaneously.

42. A kit for accessing, accessing, collecting and analyzing a sample of fluid, comprising a plurality of the strip of claim 33.