Flexible test strip lancet device

• US 7,479,119 B2
• Filed: 04/04/2007
• Issued: 01/20/2009
• Est. Priority Date: 12/30/2002
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/696,260
• Publication Number:
  US 20070191739A1
• Time in Patent Office: 657 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 606/181, 606/182
• US Class Current: 600/584
• 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

Abstract

A bodily fluid sampling device includes a flexible test strip, a lancet, and a deflection mechanism. The test strip is biased to be positioned over the incision site formed by the lancet. The deflection mechanism positions the test strip away from the incision site during lancing so as to allow the lancet to have clear access to the incision site. Due to the flexible nature of the test strip, after lancing the incision, the test strip returns to the original position so as to collect fluid from the incision.

Claims

1. A method of sampling a body fluid, comprising:

deflecting a fluid collection means away from an incision site and away from a lancet of a body fluid sampling device with a deflection mechanism;

forming an incision in skin at the incision site with the lancet of the body fluid sampling device that includes the fluid collection means while the fluid collection means is resiliently biased away from the incision by said deflecting;

releasing the fluid collection means that was biased away from the incision site in order to resiliently move the fluid collection means over the incision site to collect the body fluid from the incision;

wherein the deflection mechanism includes a cam arm that is coupled to the lancet to move in unison with the lancet; and

wherein said deflecting includes pressing the cam arm against the fluid collection means to bend the fluid collection means.

2. The method of claim 1, wherein said releasing includes retracting the lancet to disengage the cam arm from the fluid collection means.

3. The method of claim 2, further comprising:

wherein the fluid collection means includes a test strip; and

analyzing the body fluid with the test strip.

4. The method of claim 1, farther comprising:

wherein the fluid collection means includes a test strip; and

analyzing the body fluid with the test strip.

5. A method, comprising:

moving a test strip away from an incision site by bending a resilient member;

forming an incision at the incision site after said moving;

returning the test strip that was moved away back to the incision site by allowing the resilient member to spring back;

collecting body fluid from the incision with the test strip;

the resilient member including the test strip; and

said moving including bending the test strip.

6. The method of claim 5, further comprising:

said forming the incision including piercing the skin with a lancet; and

said bending the test strip including bending the test strip with a cam arm that moves in unison with the lancet.

7. A method, comprising:

providing a sampling device with a fluid collection means at least in part located at an incision site;

moving the fluid collection means out of the way of an incision forming means of the sampling device;

forming an incision at the incision site with the incision forming means when the fluid collection means is out of the way;

returning the fluid collection means that was moved out of the way back to the incision site after said forming the incision;

collecting the fluid with the fluid collection means;

the fluid collection means including a test strip; and

said moving including bending the test strip.

8. The method of claim 7, further comprising:

the sampling device including a deflection arm coupled to the fluid collection means;

the incision forming means including a lancet;

said forming the incision including firing the lancet upon actuation of a trigger mechanism; and

said moving including bending the deflection arm with the trigger mechanism.