Integrated lancing test strip with retractable lancet

• US 8,328,737 B2
• Filed: 09/08/2011
• Issued: 12/11/2012
• Est. Priority Date: 04/12/2005
• Status: Active Grant

• 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:
  US13/228,163
• Publication Number:
  US 20120004521A1
• Time in Patent Office: 460 Days
• Field of Search: 600/573, 600/583, 600/584, 606/181, 606/182
• 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. An apparatus, comprising:

an integrated lancing test strip device including

a lancet configured to form an incision in tissue,

a test strip coupled to the lancet for analyzing body fluid from the incision, and

a retention mechanism that holds the lancet in a static position relative to the test strip where at least a portion of the lancet extends from a distal end of the test strip in an extended state before formation of the incision, wherein the retention mechanism is configured to release the lancet from the extended state for retracting the lancet relative to the distal end of the test strip in order to reduce interference by the lancet during collection of the body fluid with the test strip, wherein the lancet is configured to retract in a translational fashion relative to the distal end of the test strip.

2. The apparatus of claim 1, further comprising a protective cover covering the is portion of the lancet extending from the test strip, wherein the retention mechanism holds the lancet during removal of the protective cover.

3. The apparatus of claim 2, wherein the protective cover includes a plastic cap configured to be pulled off the lancet prior to use.

4. The apparatus of claim 1, wherein the retention mechanism includes one or more breakable tabs coupled between the lancet and the test strip, wherein the breakable tabs are configured to break when a predefined force is applied to permit retraction of the lancet.

5. The apparatus of claim 4, wherein the breakable tabs are made of a fracturable plastic.

6. The apparatus of claim 1, wherein the retention mechanism includes one or more detents that engage the lancet, wherein the detents are configured to release the lancet when a predefined force is applied to permit retraction of the lancet.

7. The apparatus of claim 1, wherein the retention mechanism includes adhesive adhering the lancet to the test strip, the adhesive being configured to release the lancet when a predefined force is applied to permit retraction of the lancet.

8. The apparatus of claim 1, wherein the lancet defines one or more engagement openings for transmitting force during retraction.

9. The apparatus of claim 1, wherein the retention mechanism is configured to hold the lancet in a retracted position after formation of the incision to reduce risk of injury during disposal of the integrated lancing test strip device.

10. The apparatus of claim 1, further comprising:

an actuation mechanism coupled to the integrated lancing test strip, wherein the actuation mechanism includes a deflection mechanism configured to swipe the test strip over the body fluid from the incision.

11. The apparatus of claim 10, wherein the actuation mechanism includes a retraction mechanism configured to apply force to release the lancet from the retention mechanism and retract the lancet.

12. The apparatus of claim 1, further comprising:

wherein the lancet is disposed inside a lancet channel configured to guide the lancet during lancing; and

a cover sheet covering the lancet channel to retain the lancet in the lancet channel.

13. The apparatus of claim 12, further comprising:

a spacer defining the lancet channel, the spacer being attached to the test strip; and

wherein the cover sheet covers the spacer.

14. The apparatus of claim 12, further comprising:

wherein the test strip defines the lancet channel; and

wherein the cover sheet covers the test strip at the lancet channel.

15. The apparatus of claim 1, further comprising:

a protective cover covering the portion of the lancet extending from the test strip, wherein the retention mechanism holds the lancet during removal of the protective cover;

wherein the protective cover includes a plastic cap configured to be pulled off the lancet prior to use;

wherein the retention mechanism includes one or more breakable tabs coupled between the lancet and the test strip, wherein the breakable tabs are configured to break when a predefined force is applied to permit retraction of the lancet;

wherein the breakable tabs are made of a fracturable plastic;

wherein the lancet defines one or more engagement openings for transmitting force during retraction;

an actuation mechanism coupled to the integrated lancing test strip, wherein the actuation mechanism includes a deflection mechanism configured to swipe the test strip over the body fluid from the incision;

wherein the actuation mechanism includes a retraction mechanism configured to apply force to release the lancet from the retention mechanism and retract the lancet;

wherein the lancet is disposed inside a lancet channel configured to guide the lancet during lancing; and

a cover sheet covering the lancet channel to retain the lancet in the lancet channel.

16. The apparatus of claim 1, further comprising:

an actuation mechanism coupled to the integrated lancing test strip, the actuation mechanism being configured to fire the integrated lancing test strip to form the incision in the tissue,

wherein the retention mechanism holds the lancet in the extended state to cause the lancet and the test strip to move in unison towards the tissue as the actuation mechanism fires the integrated lancing test strip; and

wherein the actuation mechanism is configured to release the retention mechanism to retract the lancet relative to the test strip after forming the incision.

17. The apparatus of claim 16, further comprising:

the retention mechanism including one or more breakable tabs coupled between the lancet and the test strip;

the breakable tabs being configured to break when a predefined force is applied to permit retraction of the lancet; and

the actuation mechanism being configured to apply the predefined force to break the breakable tabs.

18. The apparatus of claim 16, further comprising:

the retention mechanism including one or more detents that engage the lancet;

the detents being configured to release the lancet when a predefined force is applied to permit retraction of the lancet; and

the actuation mechanism being configured to apply the predefined force to release the lancet from the detents.