Integrated lancet and bodily fluid sensor

• US 7,192,405 B2
• Filed: 09/30/2002
• Issued: 03/20/2007
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Karl, Frederick, Chelak, Todd M., West, Robert E., DeNuzzio, John D., Allen, William, Stewart, Bill, Palmer, Phyllis, Keith, Steven, Monahan, Lawrence A., Griswold, Lee
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/259,798
• Publication Number:
  US 20040064068A1
• Time in Patent Office: 1,632 Days
• Field of Search: 600/584, 600/583, 600/573, 600/578, 436/169, 422/56, 422/58, 422/100, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• 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 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/1519 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: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

Claims

1. A bodily fluid sample acquisition and testing device comprising:

a lancet adapted to be engaged by a lancing device;

a bodily fluid chemistry sensing strip comprising a sensing area; and

a primary support member adapted to fixedly engage said sensing strip, and to slidably engage said lancet, said primary support member further comprising a slot adapted to allow contact between said lancet and said lancing device, said lancing device being adapted to slide said lancet in the direction of said slot between an unexposed position and an exposed position.

2. The bodily fluid sample acquisition and testing device of claim 1, wherein said sensing area is in electrical contact with two electrodes.

3. The bodily fluid sample acquisition and testing device of claim 1, wherein said sensing area is adjacent to said exposed position of said lancet.

4. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip comprises a wick.

5. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one microliter.

6. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one half microliter.

7. A bodily fluid sample acquisition and testing device comprising:

a lancet adapted to be engaged by a lancing device; and

a primary support member adapted to fixedly engage a bodily fluid chemistry sensing strip, and to slidably engage said lancet, said primary support member further comprising a slot adapted to allow contact between said lancet and said lancing device, said lancing device adapted to slide said lancet between an unexposed position and an exposed position.

8. A bodily fluid sample acquisition and testing device comprising:

a primary support member having a bodily fluid chemistry sensing strip attached thereto, said sensing strip comprising a sensing area in proximity to a sensing end of said primary support member;

a cantilever member comprising a first end hinged to said support member;

a lancing member comprising a lancet support member and a lancet having a pointed end attached to said lancet support member, said lancet support member being hinged to a second end of said cantilever member;

said primary support member, cantilever member, and lancing member adapted to adopt a first orientation being substantially coplanar, and to adopt a second orientation with said lancing member defining an angle with said primary support member such that said pointed end of said lancet is adjacent to said sensing area of said sensing strip.

9. The bodily fluid sample acquisition and testing device of claim 8, wherein said sensing area is in electrical communication with two electrodes.

10. The bodily fluid sample acquisition and testing device of claim 8, wherein said primary support member has a substantially flat orientation.

11. The bodily fluid sample acquisition and testing device of claim 8, wherein said lancet is slidably attached to said lancet support member such that said lancet is adapted to be inserted into and withdrawn from a patient'"'"'s skin.

12. The bodily fluid sample acquisition and testing device of claim 8, wherein said angle is a right angle.

13. The bodily fluid sample acquisition and testing device of claim 8, wherein said angle is an acute angle.

14. The bodily fluid sample acquisition and testing device of claim 8, wherein said primary support member has a first surface defining a plane, and wherein said device further comprises a lancer adapted to engage said lancet in said second orientation, and to drive said lancet past said plane into a patient'"'"'s skin.

15. A bodily fluid sample acquisition and testing device comprising:

a primary support member adapted to engage a bodily fluid chemistry sensing strip, said sensing strip comprising a sensing area in proximity to a sensing end of said primary support member;

a cantilever member comprising a first end hinged to said support member;

a lancing member comprising a lancet support member and a lancet having a pointed end attached to said lancet support member, said lancet support member being hinged to a second end of said cantilever member;

said primary support member, cantilever member, and lancing member adapted to adopt a first orientation being substantially coplanar, and to adopt a second orientation with said lancing member defining an angle with said primary support member such that said pointed end of said lancet is adjacent to said sensing area of said sensing strip.

16. The bodily fluid sample acquisition and testing device of claim 15, wherein said sensing area is in electrical communication with two electrodes.

17. A bodily fluid sample acquisition and testing device comprising:

a primary support member enclosing a lancet and a bodily fluid chemistry sensing strip, said primary support member having a first port adapted to allow a point of said lancet to extend out of said primary support member and a second port adjacent to said first port in fluid communication with a sensing end of said sensing strip; and

a primary support member holding mechanism adapted to drive said lancet point out of said first port, retract said lancet, and move said primary support member to align said second port with a wound created by said lancet.

18. The bodily fluid sample acquisition and testing device of claim 17, further comprising:

a first spring adapted to drive said lancet into the skin of a patient;

a pushbutton adapted to release said lancet; and

a second spring adapted to realign said primary support member after said lancet is withdrawn from said patient.

19. The bodily fluid sample acquisition and testing device of claim 17, further comprising a wick in fluid communication with said sensing strip.

20. The bodily fluid sample acquisition and testing device of claim 17, wherein said primary support member holding mechanism is further adapted to move said primary support member after a fluid droplet has formed at said wound, said fluid droplet having attained a minimum volume of 0.25 μ

l.

21. A bodily fluid sample acquisition and testing device comprising:

a primary support member enclosing a lancet and adapted to engage a bodily fluid chemistry sensing strip, said primary support member having a first port adapted to allow a point of said lancet to extend out of said primary support member and a second port adjacent to said first port in fluid communication with a sensing end of said sensing strip; and

a primary support member holding mechanism adapted to drive said lancet point out of said first port, retract said lancet, and move said primary support member to align said second port with a wound created by said lancet.

22. A method of obtaining and testing a bodily fluid sample comprising the steps of:

inserting a testing cartridge into a testing device, said testing cartridge comprising at least one sensing strip adjacent to a lancet;

driving said lancet into the skin of a patient to cause a wound in a direction substantially aligned with a length of said sensing strip;

retracting said lancet from said patient; and

moving said cartridge after said wound is created so that said sensing strip is aligned with said wound.

23. The method of claim 22, further comprising the steps of:

drawing bodily fluid from said wound into said sensing strip;

applying a voltage across said sensing strip; and

measuring a current through said sensing strip.

24. The method of claim 23, wherein said bodily fluid comprises less than one microliter.

25. The method of claim 23, wherein said bodily fluid comprises less than one-half microliter.

26. The method of claim 22, further comprising the steps of:

drawing bodily fluid from said wound into said sensing strip;

applying a current through said sensing strip; and

measuring a voltage across said sensing strip.

27. A bodily fluid sample acquisition and testing device comprising:

a lancet; and

a primary support member comprising a first slot adapted to engage a bodily fluid chemistry sensing strip, said strip comprising a sensing area;

said primary support member further comprising a second slot, said second slot being substantially parallel to said first slot, said second slot adapted to allow contact between said lancet and a lancet driver adapted to engage said lancet to provide slidable translation of said lancet between an unexposed position and an exposed position;

wherein said bodily fluid chemistry sensing strip is adjacent to said exposed position of said lancet.

28. The bodily fluid sample acquisition and testing device of claim 27, wherein said sensing area is in electrical contact with at least two electrodes.

29. The device of claim 27, wherein said primary support member has a substantially flat orientation.

30. A bodily fluid sample acquisition and testing device comprising:

a lancet; and

a primary support member comprising a first slot adapted to engage a bodily fluid chemistry sensing strip, said sensing strip comprising a sensing area;

said primary support member further comprising a second slot, said second slot being substantially parallel to said first slot, said second slot adapted to allow contact between said lancet and a lancet driver adapted to engage said lancet to provide slidable translation of said lancet between an unexposed position and an exposed position;

wherein said bodily fluid chemistry sensing strip is adjacent to a wound produced by said lancet in said exposed position.

31. The device of claim 30, wherein said sensing area is in electrical contact with at least two electrodes.

32. The device of claim 30, wherein said primary support member has a substantially flat orientation.

33. A method of obtaining a bodily fluid sample for testing, comprising the steps of:

inserting at least one bodily fluid chemistry sensing strip into a primary support member having a first slot adapted to receive said bodily fluid chemistry sensing strip;

said strip comprising a sensing area;

said primary support member further comprising a second slot adapted to receive at least one lancet and to allow contact between said lancet and a lancet driver;

said lancet adapted to be engaged by said lancet driver;

placing said primary support member against skin; and

activating said lancet driver to traverse said lancet into said skin to provide a bodily fluid sample.

34. The method of claim 33, wherein said sensing area is in electrical contact with at least two electrodes.

35. The method of claim 33 further comprising the step of positioning said bodily fluid chemistry sensing strip adjacent said bodily fluid sample to cause said sample to flow to said sensing area.