Integrated lancing test strip with retractable lancet

• US 7,695,442 B2
• Filed: 04/12/2005
• Issued: 04/13/2010
• 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:
  US11/103,871
• Publication Number:
  US 20060229532A1
• Time in Patent Office: 1,827 Days
• Field of Search: 600/573, 600575-584, 606181-185
• 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 that faces a tissue;

forming an incision in the tissue with the portion of the lancet extending from the distal end of the test strip;

releasing the lancet from the fixed position;

retracting the lancet after said forming the incision, wherein said retracting includes rotating the lancet relative to the test strip where the portion of the lancet is located inside the distal end of 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, wherein said releasing the lancet occurs after said forming the incision.

3. 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.

4. The method of claim 1, further comprising:

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

5. The method of claim 4, further comprising:

wherein the protective cover includes a plastic cap; and

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

6. An apparatus, comprising:

an integrated lancing test strip device including

a test strip for analyzing body fluid, the test strip having a capillary channel with an opening at a distal end of the test strip for drawing the body fluid via capillary action,

a lancet directly coupled to the test strip for forming an incision in tissue, wherein the lancet is pivotally coupled to the test strip, and

a pivot pin pivotally coupling the lancet to the test strip to allow the lancet rotate relative to the test strip; and

an actuation device coupled to the integrated lancing test strip device, the actuation device being configured to fire the lancet into the tissue, wherein the actuation device is configured to rotate the lancet away from the incision in order to minimize interference by the lancet as the body fluid from the incision is drawn into the capillary channel of the test strip, wherein the actuation device is configured to rotate the lancet relative to the test strip from a position where the lancet extends past the distal end of the test strip to a position where the lancet is retracted inside the distal end of the test strip.

7. The apparatus of claim 6, further comprising:

a retention mechanism holding the lancet fixed relative to the test strip.

8. The apparatus of claim 7, further comprising:

the retention mechanism including one or more retention pins.

9. The apparatus of claim 7, further comprising:

the lancet including a lancet tip configured to form the incision in the tissue; and

the retention mechanism holding the lancet at an orientation where the lancet tip extends from the test strip.

10. The apparatus of claim 9, further comprising:

a protective cover covering the lancet tip.

11. The apparatus of claim 10, wherein the protective cover includes a plastic cap configured to be pulled off the lancet tip.

12. The apparatus of claim 7, wherein the retention mechanism is configured to hold the lancet in position after the lancet is rotated.

13. The apparatus of claim 6, wherein the test strip includes an analysis portion that includes a reagent and electrodes for analyzing the body fluid.

14. An apparatus, comprising:

an integrated lancing test strip device including

a test strip including a capillary channel with an opening for drawing body fluid via capillary action and a reagent for analyzing the body fluid, the test strip having a distal end at the opening of the capillary channel,

a pivot pin coupled to the test strip,

a lancet pivotally coupled by the pivot pin to the test strip, the lancet being able to rotate relative to the test strip via the pivot pin, and

a retention mechanism holding the lancet in an extended state relative to the distal end of the test strip during lancing, the retention mechanism being configured to release the lancet during retraction to allow the lancet to rotate relative to the test strip, the retraction mechanism being configured to hold the lancet in a retracted state inside the distal end of the test strip.

15. The apparatus of claim 14, in which the retention mechanism includes a pair of retention dimples located on opposing sides of the lancet to hold the lancet in the extended state relative to the test strip during lancing.

16. The apparatus of claim 15, further comprising:

an actuation device coupled to the integrated lancing test strip device, the actuation device being configured to fire the lancet into tissue in a linear direction with the lancet in the extended state, the actuation device being configured to rotate the lancet relative to the test strip.

17. The apparatus of claim 16, further comprising:

the lancet having a pair of pin openings located on opposing sides of the pivot pin; and

the actuation device having a pair of engagement pins engageable with the pin openings to rotate the lancet relative to the test strip.

18. 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 the test strip, wherein the lancet is pivotally coupled to the test strip via a pivot pin and 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 rotating the lancet relative to the test strip about the pivot pin, wherein the retention mechanism releases the lancet to allow the lancet to rotate during said retracting;

securing the lancet in the retracted state with the retention mechanism where the lancet is rotated 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.

19. The method of claim 18, further comprising:

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

20. The method of claim 18, further comprising:

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

21. The method of claim 20, further comprising:

wherein the protective cover includes a plastic cap; and

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