Lancet Sensor Assembly and Meter

• US 20060241517A1
• Filed: 06/28/2006
• Published: 10/26/2006
• Est. Priority Date: 07/26/2004
• Status: Active Grant

• Current Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Robbins, Avi M., Stout, Jeffrey T., Fowler, James, Daggett, Robert, O'Connell, Garland, Sidwell, James S., Ruf, Chris
• Granted Patent: US 7,727,167 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150465 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 5/15113 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 5/1519 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

Abstract

A blood glucose measuring system includes a lancet assembly and a meter for use with the lancet assembly. The lancet assembly has a lancet member with a lance, a lancet body having a drive wing extending outwardly from a side, and a sinuous portion, and an elongated carrier having a lancet member recess to contain the lancet member. The elongated carrier has an open end, a closed end, a side elongated opening for receiving the drive wing therethrough, and an anchoring member operatively connected to the end of the sinuous portion. The meter includes a measuring circuit, a lancet trigger, and a lancet driver where the lancet driver includes a driver piston engageable with the lancet trigger and a charging member that operatively engages with the driver piston to move the driver piston into an armed position and to stop the driver piston when released from the armed position.

Claims

1. A lancet system comprising:

a lancet assembly comprising;

an elongated carrier having a lancet member recess, an open end, a closed end, and a first elongated side opening; and

a lancet member having a lancet body, a lance extending from a first lancet body end, a sinuous portion extending from a second lancet body end to a sinuous distal end, and a first drive wing extending outwardly from a first side of said lancet body, said lancet being disposed within said lancet member recess wherein said first drive wing extends through said first elongated side opening, said lancet body and said drive wing being slidingly engagable between a retracted position and an extended position wherein said distal end of said sinuous portion is anchored by said carrier adjacent said closed end.

2. The lancet system of claim 1 wherein said elongated carrier has a first wing guard adjacent said first elongated side opening.

3. The lancet system of claim 1 wherein said elongated carrier further includes an assembly retaining mechanism along a side peripheral edge of said lancet member recess.

4. The lancet system of claim 3 wherein said assembly retaining mechanism is a plurality of tabs.

5. The lancet system of claim 4 wherein said plurality of tabs are bendable.

6. The lancet system of claim 4 wherein said plurality of tabs are deformable.

7. The lancet system of claim 1 wherein said elongated carrier has an elongated rib on an outside bottom surface.

8. The lancet system of claim 2 wherein said first wing guard includes a first slot to accommodate a lancet driver.

9. The lancet system of claim 1 wherein said elongated carrier further includes a second elongated side opening on a side opposite to said first side.

10. The lancet system of claim 9 wherein said lancet body further includes a second drive wing extending outwardly from a second side of said lancet body and being disposed through said second elongated side opening.

11. The lancet system of claim 10 wherein said elongated carrier further includes a second wing guard adjacent said second elongated side opening.

12. The lancet system of claim 3 further comprising a sensor strip disposed on said peripheral edge of said elongated carrier and retained in said elongated carrier by said assembly retaining mechanism.

13. The lancet system of claim 12 wherein said sensor strip is sterilizable.

14. The lancet system of claim 1 wherein said elongated carrier has a first side notch adjacent said closed end.

15. The lancet system of claim 12 further comprising a portable meter, said meter comprising:

a housing;

an electronic measuring circuit disposed within said housing, said electronic measuring circuit having a test strip connector;

a display electrically connected to said electronic measuring circuit;

a lancet assembly port for receiving said lancet assembly;

a lancet driver; and

a lancet trigger having a holding member structured to hold said driver piston when said driver piston is in said armed position, said lancet assembly port configured to electrically connect said portable meter to said sensor strip and to position said drive wing of said lancet member for cooperation with said lancet driver.

16. The system of claim 15 wherein said portable meter further includes a lancing depth control having a charging member surface that cooperates with said lancet driver to control the lancing depth of said lance.

17. The system of claim 16 wherein said lancing dept control has a detent surface with a plurality of detent spaces configured to engage a detent wherein each of said plurality of detent spaces corresponds to a pre-determined lancing depth.

18. The system of claim 17 wherein said detent surface has a plurality of detent tabs that extend axially outwardly from said detent surface, said plurality of detent tabs forming said plurality of detent spaces.

19. The system of claim 16 wherein said lancing depth control has a depth gauge side containing said charging member surface wherein said charging member surface is a gradually recessing radial surface.

20. The system of claim 15 wherein said portable meter further includes a lancet assembly receiver platform connected to said lancet assembly port.

21. The system of claim 15 wherein said lancet driver includes a driver piston and a driver charging member cooperatively connected to said driver piston to position said driver piston between an “

at rest”

position and an “

armed”

position, said lancet driver disposed within said housing and positioned for cooperative engagement between said driver piston and said drive wing of said lancet member disposed within said lancet assembly that is inserted into said lancet assembly port.

22. The system of claim 21 further comprising a piston drive spring connected to said driver piston, a driver piston return spring, and a charging contact stop surface on said driver piston.

23. The system of claim 21 wherein said charging member includes a handle and a pair of charging member rails extending from the inside of said handle, said pair of charging member rails having charging member arms extending perpendicularly from the side of each of said charging member rails towards each other, said charging member arms having a stop interface for operative engagement with said charging contact stop surface on said driver piston.

24. The system of claim 23 wherein each of said charging member arms further includes a charging member return spring and a charging member arm spring receiver for connecting to one end of said charging member return spring.

25. The system of claim 23 wherein said handle extends out of a portion of the periphery of said portable meter.

26. The system of claim 22 further comprising a lancet assembly platform having a first platform side with a lancet assembly support surface, a second platform side structured for sliding engagement with said driver piston, and a cross support at a distal end, said cross support having a central portion that provides a contact surface for said piston drive spring.

27. The system of claim 26 wherein said lancet assembly support surface includes a guide groove.

28. The system of claim 26 wherein said lancet assembly platform includes a driver slot therethrough for receiving a lancet driver surface from said second platform side and beyond said first platform side for engaging said drive wing of said lancet sensor assembly.

29. The system of claim 26 wherein said lancet trigger has a trigger body, a driver piston release positioned near the base of said trigger body, a trigger arm extending transversely from the top of said trigger body, and a user interface located on said trigger arm and spaced a pre-determined distance from the top of said trigger body at a location that is along the central axis of said lancet sensor assembly port.

30. The system of claim 21 wherein said driver piston includes a drive wing engaging surface.

31. The system of claim 21 wherein said driver charging member has a handle end that extends out a predetermined distance along a peripheral edge of said housing.

32. The system of claim 26 wherein said lancet assembly port and said lancet assembly platform are axially aligned with the longitudinal axis of said portable meter.

33. The system of claim 15 wherein said lancet trigger has a user interface positioned on a trigger arm transversely connected to a trigger body wherein said user interface is axially aligned with the longitudinal axis of said portable meter and axially aligned with said lancet assembly port.

34. A method of obtaining a test sample from a specimen using a lancet system comprising:

engaging a lancet driver against a drive wing of a lancet system, said lancet system having a major portion of a lancet member slidably engaged within a lancet carrier and a sensor strip with a sample chamber attached to said lancet carrier, said lancet system having a lance connected to a first end of a lancet body of said lancet member wherein said lance is movable from a retracted position within said lancet carrier to an extended position outside said lancet carrier, said drive wing extending outwardly and perpendicularly from said lancet body, said major portion of said lancet member having a sinuous portion with a distal end restricted from movement by said lancet carrier;

moving said drive wing with said lancet driver a predetermined distance causing said lancet tip to move from said retracted position to said extended position; and

disengaging said lancet driver from said drive wing, said lance being automatically moved from said extended position to said retracted position.

35. The method of claim 34 further comprising massaging the lanced specimen to generate a sample sufficient for disposing within a sample chamber of a sensor strip connected to said lancet carrier and moving said sensor strip to said sample for receiving a portion of said sample within said sample chamber.

36. The method of claim 34 further comprising arming said lancet driver before engaging said drive wing.

37. A method of measuring blood glucose using a lancet system comprising a portable meter and a lancet assembly, said method comprising:

charging a lancet driver to an armed positioned wherein said lancet driver is incorporated within said portable meter;

inserting a lancet assembly into a lancet assembly port on said meter until said lancet assembly engages a test strip connector within said meter and electrically contacting a sensor strip of said lancet assembly, said lancet assembly having a lancet member that includes a lancet body with a drive wing extending outwardly from a side of said lancet body, a lance connected to one end of said lancet body, and a sinuous portion connected to the other end of said lancet body wherein a major portion of said lancet member is adapted to slide said lance between an unexposed position and an exposed position;

positioning the exposed end of said lancet assembly against a user'"'"'s skin;

activating said lancet driver causing a lance in said lancet assembly to lance the user'"'"'s skin;

moving said lancet system away from the lanced site;

massaging the patient'"'"'s skin near the lanced site to express a quantity of blood;

applying a portion of the expressed quantity of blood to a sample inlet on said sensor strip of said lancet assembly; and

observing test results displayed by said portable meter.

38. The method of claim 37 further comprising adjusting a lancing depth control of said portable meter to a selectable depth setting.