Integrated lancing test strip with retractable lancet

• US 8,025,628 B2
• Filed: 02/22/2010
• Issued: 09/27/2011
• Est. Priority Date: 04/12/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wong, Daniel, Chan, Frank
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/709,543
• Publication Number:
  US 20100145230A1
• Time in Patent Office: 582 Days
• Field of Search: 600/573, 600575-584, 606180-185
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150213 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 5/150412 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• 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 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• 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

An integrated lancing test strip device includes a lancet configured to form an incision in tissue and a test strip coupled to the lancet for analyzing body fluid. A retention mechanism acts as a detent to hold the lancet in a static position relative to the test strip before forming the incision. The retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip to reduce smearing of body fluid by the lancet during collection of the fluid with the test strip. In one form, the retention mechanism includes breakable tabs that are broken to release the lancet, and the lancet is retracted via translational movement. The retention mechanism in another form includes one or more dimples that release the lancet when the lancet is retracted via rotational motion. In a further form, the entire integrated device is rotated to collect fluid.

Claims

1. A method, comprising:

holding a lancet in a fixed position relative to a test strip of an integrated lancing test strip device where at least a portion of the lancet extends from a distal end of the test strip in an extended state, wherein a retention mechanism holds the lancet in the extended state;

forming an incision in tissue with the portion of the lancet extending from the test strip in the extended state, wherein during said forming the incision the lancet and the test strip move in unison towards the tissue due to the retention mechanism holding the lancet in the extended state;

releasing the lancet from the fixed position by releasing the retention mechanism;

retracting the lancet relative to the test strip after said forming the incision, wherein said retracting includes translationally moving of the lancet relative to the test strip; and

collecting body fluid from the incision with the test strip after said retracting the lancet.

2. The method of claim 1, further comprising:

wherein said holding the lancet in the fixed position facilitates accurate penetration depth of the lancet into the tissue;

wherein the test strip includes a capillary channel with a capillary channel opening;

maintaining spacing between the capillary channel opening of the test strip and the tissue during said retracting the lancet relative to the test strip; and

wherein said collecting the body fluid includes drawing the body fluid into the capillary channel via the capillary channel opening while the spacing between the capillary channel opening of the test strip is maintained.

3. The method of claim 1, wherein said releasing the lancet occurs after said forming the incision.

4. The method of claim 1, further comprising:

wherein said collecting includes swiping the test strip over the body fluid from the incision with a deflection mechanism.

5. The method of claim 4, further comprising:

wherein said swiping the test strip over the body fluid includes bending the test strip; and

wherein said retracting includes retracting the lancet into the test strip to make said bending of the test strip easier.

6. The method of claim 1, further comprising:

removing a protective cover from the lancet before said forming the incision.

7. The method of claim 6, further comprising:

wherein the protective cover includes a cap; and

wherein said removing the protective cover includes pulling the cap off the lancet.

8. The method of claim 1, further comprising:

wherein said holding the lancet in the fixed position facilitates accurate penetration depth of the lancet into the tissue;

wherein the test strip includes a capillary channel with a capillary channel opening;

maintaining spacing between the capillary channel opening of the test strip and the tissue during said retracting the lancet relative to the test strip;

wherein said collecting the body fluid includes drawing the body fluid into the capillary channel via the capillary channel opening while the spacing between the capillary channel opening of the test strip is maintained;

wherein said releasing the lancet occurs after said forming the incision;

removing a protective cover from the lancet before said forming the incision;

wherein the protective cover includes a cap; and

wherein said removing the protective cover includes pulling the cap off the lancet.

9. The method of claim 1, wherein said retracting the lancet includes holding the test strip stationary while the lancet moves away from the tissue.

10. The method of claim 1, further comprising:

retaining the lancet inside the integrated lancing test strip device with the retention mechanism after said retracting the lancet.

11. The method of claim 1, further comprising:

retaining the lancet inside the integrated lancing test strip device without a spring with the retention mechanism after said retracting the lancet.

12. The method of claim 1, further comprising:

connecting the integrated lancing test strip device to a lancing mechanism via a connector;

engaging the lancet to a retraction arm;

wherein said forming the incision includes firing the connector along with the retraction arm in unison with the lancing mechanism; and

wherein said retracting the lancet includes retracting the lancet away from the tissue with the retraction arm while the connector holds the test strip stationary.

13. The method of claim 1, further comprising:

wherein the retention mechanism includes one or more breakable tabs; and

wherein said releasing the lancet from the fixed position includes breaking the one or more breakable tabs.

14. The method of claim 1, further comprising:

wherein the retention mechanism includes one or more detents; and

wherein said releasing the lancet from the fixed position includes disengaging the detents from the lancet.

15. A method, comprising:

holding a lancet in an extended state relative to a test strip of an integrated lancing test strip device with a retention mechanism, wherein at the extended state at least a portion of the lancet extends from a distal end of the test strip, wherein the retention mechanism holds the lancet in the extended state;

forming an incision in tissue with the lancet in the extended state by moving the integrated lancing test strip device in a linear direction into the tissue;

retracting the lancet to a retracted state after said forming the incision by moving the lancet relative to the test strip in a linear direction, wherein the retention mechanism releases the lancet to allow the lancet to move in the linear direction during said retracting;

securing the lancet in the retracted state with the retention mechanism where the lancet is moved inside the distal end of the integrated lancing test strip device as a result of said retracting; and

collecting body fluid from the incision with the test strip after said retracting the lancet.