Lancet, lancet assembly and lancet-sensor combination

• US 20060020228A1
• Filed: 07/26/2004
• Published: 01/26/2006
• Est. Priority Date: 07/26/2004
• Status: Active Grant

• Current Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Fowler, James, Daggett, Robert, O'Connell, Garland
• Granted Patent: US 7,727,166 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 lancet assembly has a lancet body with a needle end, a sinuous portion end, and a slot, a lancet tip connected to the needle end, a sinuous portion connected to the sinuous portion end, an anchor structure connected to the sinuous portion. The lancet assembly may also include a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with the elongated chamber opposite the needle end, and a lancet enclosure slot in communication with the elongated chamber and spaced from the needle end. The anchor end is configured to receive and hold the anchor structure in a substantially static position. The elongated chamber is sized to receive in sliding engagement the lancet tip, the lancet body where the lancet body slot is in communication with the lancet enclosure slot and the sinuous portion and to permit slidable movement of the lancet tip through the open end between a retracted position and an extended position.

Claims

1. An integrated lancet and test strip comprising:

a lancet assembly comprising;

a lancet body having a lancet tip end, a sinuous portion end, and a slot;

a lancet tip connected to said lancet tip end;

a sinuous portion connected to said sinuous portion end; and

an anchor portion connected to said sinuous portion; and

a lancet enclosure having an elongated chamber with a needle end, an anchor structure in communication with said elongated chamber opposite said needle end, and a lancet enclosure slot in a bottom of said lancet enclosure and spaced from said needle end, said lancet enclosure slot being in communication with said elongated chamber and communicating with said lancet body slot wherein said elongated chamber is sized to receive in sliding engagement said lancet tip, said lancet body and said sinuous portion and wherein said anchor structure is sized to receive said anchor portion; and

a test strip bonded to said lancet assembly.

2. The device of claim 1 further comprising a lancet gun device having a lancet receiver for receiving said integrated lancet and test strip, a lancet driver configured for engaging said lancet body slot through said lancet enclosure slot and moving said lancet tip between a resting position and an extended position, and an activating member engageable with said lancet driver to activate said lancet gun device between a loaded position and a released position.

3. The device of claim 1 wherein said sinuous portion is stretchable.

4. A lancet assembly comprising:

a lancet body having a needle tip end, a sinuous portion end, and a slot;

a lancet tip connected to said lancet tip end;

a sinuous portion connected to said sinuous portion end;

an anchor portion connected to said sinuous portion; and

a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with said elongated chamber opposite said needle end, and a lancet enclosure slot in a bottom of said lancet enclosure and spaced from said needle end, said lancet enclosure slot being in communication with said elongated chamber and communicating with said lancet body slot, said anchor portion being sized to receive and hold said anchor portion in a substantially static position and wherein said elongated chamber is sized to receive in sliding engagement said lancet tip, said lancet body and said sinuous portion and to permit slidable movement of said lancet tip through said needle end between a resting position and an extended position.

5. The lancet assembly of claim 4 wherein said sinuous portion is stretchable.

6. The lancet assembly of claim 4 further comprising a cover over said elongated chamber.

7. The lancet assembly of claim 4 further comprising a lancet gun device having a lancet receiver for receiving said lancet assembly, a lancet driver configured for engaging said lancet body slot through said lancet enclosure slot and moving said lancet tip between a resting position and an extended position, and an activating member engageable with said lancet driver to activate said lancet gun device between a loaded position and a released position.

8. A lancet assembly comprising:

a lancet body having a needle end, a sinuous portion end, and a slot;

a lancet tip connected to said needle end;

a sinuous portion connected to said sinuous portion end; and

an anchor structure connected to said sinuous portion.

9. The lancet assembly of claim 8 further comprising a lancet gun device having a lancet receiver for receiving said lancet assembly, a lancet driver configured for engaging said lancet body slot and moving said lancet tip between a resting position and an extended position, and an activating member engageable with said lancet driver to activate said lancet gun device between a loaded position and a released position.

10. The lancet assembly of claim 8 further comprising a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with said elongated chamber opposite said needle end, and a lancet enclosure slot in a bottom of said lancet enclosure and spaced from said needle end, said lancet enclosure slot being in communication with said elongated chamber and communicating with said lancet body slot, said anchor end being configured to receive and hold said anchor structure in a substantially static position and wherein said elongated chamber is sized to receive in sliding engagement said lancet tip, said lancet body and said sinuous portion and to permit slidable movement of said lancet tip through said needle end between a resting position and an extended position.

11. The lancet assembly of claim 10 further comprising a test strip bonded to said lancet assembly.

12. The lancet assembly of claim 11 further comprising a lancet gun device having a lancet receiver for receiving said lancet assembly, a lancet driver configured for engaging said lancet body slot and moving said lancet tip between a resting position and an extended position, and an activating member engageable with said lancet driver to activate said lancet gun device between a loaded position and a released position.

13. The lancet assembly of claim 10 further comprising a lancet gun device having a lancet receiver for receiving said lancet assembly, a lancet driver configured for engaging said lancet body slot and moving said lancet tip between a resting position and an extended position, and an activating member engageable with said lancet driver to activate said lancet gun device between a loaded position and a released position.

14. A method of using a lancet assembly comprising:

holding in a substantially stationary position an anchor structure of a lancet assembly having a lancet body with a lancet slot, a lancet tip connected to one end of said lancet body, a sinuous portion connected to a second end of said lancet body, an anchor structure attached to an opposite end of said sinuous portion and a lancet driver engaged within said lancet slot;

moving said lancet tip from a starting position to an extended position by moving said lancet driver in said lancet slot; and

retracting said lancet tip from said extended position by reversing the direction of said lancet driver in said lancet slot.

15. The method of claim 14 further comprising slidably engaging said lancet driver into said lancet slot from a slot disengaged position to a slot engaged position.

16. The method of claim 15 further comprising disengaging said lancet driver from said lancet slot.

17. A method of lancing a specimen comprising:

engaging a lancet driver into a lancet slot of a lancet assembly, said lancet assembly having a major portion of a lancet body slidably engaged within a lancet enclosure having a needle end wherein a lancet tip is movable from a retracted position within said lancet enclosure to an extended position outside said lancet enclosure through said needle end, said major portion of said lancet body having a sinuous portion connected to an anchor structure wherein said anchor structure is retained in a substantially fixed position within said lancet enclosure;

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

retracting said lancet driver from said predetermined distance allowing said lancet tip to move from said extended position to said retracted position.

18. The method of claim 17 further comprising slidably engaging said lancet driver into said lancet slot from a disengaged position to an engaged position.

19. The method of claim 18 further comprising disengaging said lancet driver from said lancet slot after retracting said lancet driver from said predefined distance.