Lancet drive system depth control method and test strip location methods

• US 9,167,992 B2
• Filed: 11/03/2010
• Issued: 10/27/2015
• Est. Priority Date: 11/03/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N., Keil, Michael, Raney, Charles C.
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/938,858
• Publication Number:
  US 20120109176A1
• Time in Patent Office: 1,819 Days
• Field of Search: 600/583, 606/181, 606/182
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• 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 5/15126 Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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

Adjustment mechanisms are used in conjunction with integrated lancet test strips to adjust the position of the drive system, engagement system, or the drive coupling in a fixed stroke lancing system to thereby adjust the penetration depth of the lancet. In a variable drive stroke lancing system, the lancet penetration depth is adjusted by changing the stroke length of a drive system. The stroke length of a drive system is adjusted by rotating a cam or sliding a cam in a cam type drive system. In either the fixed or the variable drive stroke lancing system, the test strip and/or guidance foil of the integrated lancet test strip is immobilized while the lancet is actuated.

Claims

1. An apparatus, comprising:

an integrated lancing test strip including a lancet for forming an incision in tissue and a test strip configured to analyze a body fluid sample;

a driver system configured to move the lancet to form an incision, the driver system having a fixed stroke length to move the lancet, the driver system including;

a driver configured to fire the lancet, the driver having an extension mechanism;

a drive actuator;

a cam engagement member configured to connect the drive actuator with the driver, the cam engagement member defines a first opening sized to receive the extension mechanism, wherein the drive actuator is configured to move the cam engagement member; and

an engagement mechanism configures to hold the test strip stationary while the lancet is moved to form the incision in tissue, the engagement mechanism configured to receive the driver and the cam engagement member, the engagement mechanism defines a second opening sized to receive the extension mechanism, wherein the first opening and the second opening are arranged to limit a distance the driver moves when the driver fires the lancet;

and

an adjustment mechanism configured to move the driver system to adjust a starting position of the driver system, to adjust a distance the extension mechanism travels in the first and the second openings, and to adjust the depth of penetration of the lancet in tissue.

2. The apparatus of claim 1, wherein the adjustment mechanism is positioned on the engagement mechanism and the adjustment mechanism is configured to adjust a starting position of the cam engagement member.

3. The apparatus of claim 1, wherein the adjustment mechanism is positioned on the drive actuator and the adjustment mechanism is configured to adjust a starting position of a firing mechanism.

4. The apparatus of claim 1, wherein the adjustment mechanism is positioned on a drive shaft and the adjustment mechanism is configured to adjust a starting position of the cam engagement member.

5. An apparatus, comprising:

an integrated lancing test strip including a lancet configured to form an incision in tissue and a test strip configured to analyze a body fluid sample;

an integrated lancet test strip holder to hold the test strip stationary while the lancet forms the incision;

a driver system configured to move the lancet to form an incision, the driver system having a variable stroke length to move the lancet, the driver system including;

a driver configured to move the lancet;

a drive wheel that is rotatable to adjust the stroke length of the driver;

a cam that is movable to adjust an eccentricity of the drive wheel and a stroke length of the lancet; and

a platform configured to receive and retain the integrated lancet test strip holder.

6. The apparatus of claim 5, wherein the drive wheel includes a plurality of holes and the cam includes a peg sized to fit into one of the plurality of holes as the cam is rotated about the drive wheel.

7. The apparatus of claim 5, wherein the cam is configured to slide in a lateral direction relative to the direction of lancing to adjust the eccentricity of the drive wheel.

8. The apparatus of claim 7, further comprising a yoke configured to engage and move the lancet, wherein a lateral adjustment of the cam does not change a starting position of the yoke.

9. The apparatus of claim 5, wherein the cam is configured to rotate to adjust an eccentricity of the drive wheel.

10. The apparatus of claim 5, wherein the integrated lancet test strip holder defines an opening sized to receive a portion of the driver that moves the lancet to form the incision.

11. The apparatus of claim 5, wherein the test strip includes a first feature and the integrated lancet test strip holder includes a second feature sized to matingly engage the first feature on the test strip.

12. A method, comprising:

providing an integrated lancing test strip including a lancet for forming an incision in tissue and a test strip configured to analyze a body fluid sample;

providing an integrated lancet test strip holder to hold the test strip stationary while the lancet forms the incision;

providing a driver system configured to receive a driver and the integrated lancing test strip holder, wherein the driver is configured to move the lancet;

modifying a stroke length of the driver by moving a cam prior to actuation of the lancet, wherein the modified stroke length adjusts a penetration depth of the lancet in tissue, wherein the cam moves closer to a centerline of the driver to reduce the penetration depth of the lancet and the cam moves further away from the centerline of the driver to increase the penetration depth of the lancet; and

holding the test strip stationary in the integrated lancet test strip holder.

13. The method of claim 12, wherein the moving the cam includes sliding the cam perpendicular to a direction of lancing.

14. The method of claim 12, further comprising:

a drive wheel defines a plurality of openings; and

the moving the cam includes rotating the cam wherein a peg on the cam engages one of the plurality of openings on the drive wheel.

15. The method of claim 12, further comprising:

the lancet defines an engagement notch sized to receive the driver; and

the modifying the stroke length of the driver includes maintaining alignment of the driver with the engagement notch.

16. The method of claim 12, wherein the modifying the stroke length of the driver maintains a starting position of the driver at a constant position.