Lancing device

• US 7,438,694 B2
• Filed: 03/07/2006
• Issued: 10/21/2008
• Est. Priority Date: 03/07/2006
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Flaherty, Joseph, Boozer, Brad, Golnik, Timothy
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/276,598
• Publication Number:
  US 20070213637A1
• Time in Patent Office: 959 Days
• Field of Search: 600/584, 600/583, 600/573, 606/181, 606/182, 606/183
• 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 5/150358 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 5/15113 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 5/1519 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: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A lancing device is used with a lancet for lancing body tissue to result in a wound for bleeding. An improved lancing device has a priming knob having a slanted priming notch rotatably connected to the lancing device about an axis of rotation generally parallel to a central axis of the lancing device and a strike path of a lancet carrier. Rotation, translation, or both rotation and translation of the priming knob allows a user to prime the lancing device.

Claims

1. A lancing device, for use with a lancet for lancing body tissue to result in a wound for bleeding, the lancing device comprising:

(1) a generally annular housing having a central axis and an internal channel extending along the central_axis terminating at a priming end of the housing and at an opposed lancing end of the housing;

(2) a priming knob rotatably and translationally connected about the housing to permit rotation about an axis of rotation generally parallel to the central axis of the housing and translation in a direction parallel to the axis of rotation, wherein the priming knob comprises a slanted priming notch for priming interaction with a priming protrusion of a lancet carrier,

(3) a lancet carrier translationally mounted within the internal channel of the housing for carrying a lancet along a strike path that is generally parallel with the central axis, the strike path of the lancet carrier starting from a primed position toward the priming end of the housing wherein the lancet is shielded by the housing and ending at a lanced position wherein a tissue penetrating portion of the lancet extends outwardly from the lancing end of the housing, the lancet carrier comprising a priming protrusion for priming interaction with the slanted priming notch of the priming knob; and

(4) a lancet carrier driver disposed within the internal channel of the housing, the lancet carrier driver being operatively engaged with the lancet carrier when driving the lancet carrier along the strike path from the primed position to the lanced position;

wherein when the slanted priming notch is in priming interaction with the priming protrusion of the lancet carrier;

(i) rotation of the priming knob is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position;

(ii) movement of the priming knob along an axis generally parallel to the central axis of the housing is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position and (iii) a combination of both rotation of the priming knob and movement of the priming knob along an axis generally parallel to the central axis of the housing, prunes the lancet driver and places the lancet carrier into the primed position.

2. The device of claim 1, wherein the priming knob is rotatably connected to the housing at the priming end of the housing.

3. The device of claim 1, wherein the slanted priming notch is symmetrical such that when the priming notch is in priming interaction with the priming protrusion of the lancet carrier, clockwise rotation, counterclockwise rotation, or both clockwise and counterclockwise rotation of the priming knob primes the lancet driver and places the lancet carrier into the primed position.

4. The device of claim 1, wherein the slanted priming notch comprises a series of priming teeth and the priming protrusion comprises a priming tooth, and wherein when the slanted priming notch is in priming interaction with the priming protrusion of the lancet carrier and the priming knob is rotated, the priming tooth of the priming protrusion interacts with the priming teeth of the priming notch to provide a graduated ascent of the priming protrusion along the priming notch.

5. The device of claim 1, wherein:

the housing has a test strip opening sized to receive a test strip and a display opening sized to receive a meter display,

the device further comprising;

an analyte meter disposed within the generally annular housing, the analyte meter comprising;

a test strip interface for receiving a test strip;

a processor programmed to perform a diagnostic test on a sample applied to a test strip received in the test strip interface to determine a concentration of an analyte within the sample; and

the meter display for displaying the result of the analyte measurement to the user.

6. The device of claim 5, wherein the processor is programmed to determine the amount of glucose in a sample.

7. A method for priming a lancing device, wherein the method comprises the steps of, by a user:

(1) inserting a lancet into a lancet carrier of a lancing device comprising the improvement of;

a priming knob, comprising a slanted priming notch, rotatably connected to the lancing device about an axis of rotation generally parallel to a central axis of the device, wherein (i) rotation of the priming knob is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position;

(ii) movement of the priming knob along an axis generally parallel to the central axis of the device is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position and (iii) a combination of both rotation of the priming knob and movement of the priming knob along the axis generally parallel to the central axis of the device, primes a lancet driver and places the lancet carrier into a primed position,

(2) priming the lancing device by;

rotating the priming knob of the lancing device;

moving the priming knob along an axis generally parallel to the central axis of the housing;

or both rotating the priming knob of the lancing device and moving the priming knob along an axis generally parallel to the central axis of the housing,

(3) placing the lancing end of the device next to the user'"'"'s body tissue, and

(4) lancing the user'"'"'s body tissue.

8. The method of claim 7, wherein the slanted priming notch is symmetrical such that when a user performs the step of (ii) priming the lancing device, clockwise rotation, counterclockwise rotation, or both clockwise and counterclockwise rotation primes the lancet driver and places the lancet carrier into the primed position.

9. The method of claim 7, wherein the slanted priming notch comprises a series of priming teeth and the priming protrusion comprises a priming tooth, and wherein when the slanted priming notch is in priming interaction with the priming protrusion and the priming knob is rotated, the priming tooth of the priming protrusion interacts with the priming teeth of the priming notch to provide a graduated ascent of the priming protrusion along the priming notch.

10. In a lancing device, for use with a lancet carried by a lancet carrier, for lancing body tissue to result in a wound for bleeding, the improvement comprising:

a priming knob, comprising a slanted priming notch, rotatably connected to the lancing device about an axis of rotation generally parallel to a central axis of the device, wherein (i) rotation of the priming knob is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position;

(ii) movement of the priming knob along an axis generally parallel to the central axis of the device is by itself sufficient to prime the lancet driver and places the lancet carrier into a primed position; and

(iii) a combination of both rotation of the priming knob and movement of the priming knob along the axis generally parallel to the central axis of the device, primes a lancet driver and places the lancet carrier into the primed position, thereby priming the device.

11. The device of claim 10, wherein the slanted priming notch comprises a series of priming teeth and the priming protrusion comprises a priming tooth, and wherein when the slanted priming notch is in priming interaction with the priming protrusion of the lancet carrier and the priming knob is rotated, the priming tooth of the priming protrusion interacts with the priming teeth of the priming notch to provide a graduated ascent of the priming protrusion along the priming notch.