Integrated analytical test element

• US 8,157,750 B2
• Filed: 01/15/2010
• Issued: 04/17/2012
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Raney, Charles C., Roe, Steven N.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/687,920
• Publication Number:
  US 20100113978A1
• Time in Patent Office: 823 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 606181-183
• US Class Current: 600/584
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• 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 5/15123 comprising magnets or solenoids
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.

Claims

1. A method, comprising:

providing a lancet integrated test strip that includes a lancet attached to a test strip, wherein a cutting end of the lancet extends proximal a sampling end of the test strip that includes a sample chamber opening;

forming an incision in tissue with the lancet integrated test strip;

wherein said forming the incision includes bending the test strip by pressing the sampling end of the test strip against the tissue to extend the cutting end of the lancet past the sampling end of the test strip and into the tissue;

wherein the test strip includes a connector end located opposite the sample chamber opening, the lancet is attached to the test strip at the connector end;

wherein before said bending the test strip contacts the entire length of the lancet;

wherein during said bending a portion of the test strip between the sampling end and the connector end arches out of contact with the lancet; and

sampling fluid from the incision by drawing fluid into the sample chamber opening of the test strip.

2. The method of claim 1, further comprising:

analyzing the fluid from the incision with the test strip.

3. The method of claim 1, further comprising:

removing the lancet from the incision.

4. The method of claim 3, wherein said removing the lancet from the incision occurs before said sampling the fluid.

5. The method of claim 1, further comprising:

unbending the test strip prior to said sampling the fluid by moving the lancet away from the tissue.

6. The method of claim 1, wherein:

the cutting end of the lancet includes a u-shaped channel; and

said forming the incision includes cutting a u-shaped flap in the tissue with the cutting end of the lancet.

7. The method of claim 1, further comprising:

wherein the lancet integrated test strip is coupled to a holder;

wherein the holder has one or more stop surfaces; and

bracing the test strip with the stop surfaces when the test strip is bent.

8. The method of claim 1, further comprising:

wherein the test strip include a sample chamber, electrodes in the sample chamber, contact pads, and traces connecting the electrodes to the contact pads; and

wherein said bending the test strip includes bending at least the traces.

9. The method of claim 1, further comprising:

wherein the lancet is sandwiched between a protective pull type cover and the test strip; and

pulling the pull type protective cover from the test strip prior to said forming the incision.

10. The method of claim 1, further comprising:

wherein a protective band is wrapped around the test strip and the lancet; and

removing the protective band from the test strip and the lancet prior to said forming the incision.

11. The method of claim 1, further comprising:

wherein test strip includes a base substrate, a spacer layer, and a cover layer that together define a sample chamber that has the sample chamber opening; and

wherein the base substrate, spacer layer, and the cover layer all bend during said forming the incision.

12. The method of claim 1, further comprising:

wherein the lancet has a test strip attachment portion wherein the lancet is attached to the test strip; and

wherein the lancet is unattached to the test strip from the test strip attachment portion to the cutting to allow bending of the test strip between the test strip attachment portion to the sample chamber opening during said forming the incision.

13. A method, comprising:

providing a lancet integrated test strip that includes a lancet attached to a test strip, wherein a cutting end of the lancet extends proximal a sampling end of the test strip that includes a sample chamber opening;

forming an incision in tissue with the lancet integrated test strip;

wherein said forming the incision includes bending the test strip by pressing the sampling end of the test strip against the tissue to extend the cutting end of the lancet past the sampling end of the test strip and into the tissue;

sampling fluid from the incision by drawing fluid into the sample chamber opening of the test strip;

wherein the test strip includes a connector end located opposite the sampling end;

inserting the lancet integrated test strip into a deflection cavity of a holder, wherein the holder has first and second stop surfaces that define the deflection cavity, wherein the first and second stop surfaces are obliquely angled in an opposite manner, wherein during said inserting the sampling end of the test strip is positioned at the first stop surface and the connector end of the test strip is positioned at the second stop surface;

wherein said bending the test strip includes bending the test strip in the deflection cavity over the length of the test strip from the sampling end to the connector end; and

limiting the degree to which the length of the test strip bends by bracing the test strip against the first and second stop surfaces in the deflection cavity.

14. The method of claim of claim 13, further comprising:

wherein the test strip includes electrode traces that are configured to bend as the test strip bends; and

wherein the first and second stop surfaces are configured to prevent excessive bending of the electrode traces.

15. The method of claim 13, further comprising:

wherein the test strip includes contact pads at the connector end, electrodes in the sample chamber, and electrode traces operatively coupling the electrodes to the contact pads;

wherein the test strip includes electrode traces that are configured to bend as the test strip bends;

wherein the first and second stop surfaces are configured to prevent excessive bending of the electrode traces;

wherein the lancet includes a test strip attachment portion attached to the test strip at the connector end directly underneath the contact pad;

coupling to the contact pads of the test strip to a meter; and

stiffening the contact pads with the test strip attachment portion so that the contact pads remain coupled with the meter during said bending of the test strip.

16. A method, comprising:

providing a lancet integrated test strip that includes a lancet attached to a test strip, wherein a cutting end of the lancet extends proximal a sampling end of the test strip that includes a sample chamber opening;

forming an incision in tissue with the lancet integrated test strip;

wherein said forming the incision includes bending the test strip by pressing the sampling end of the test strip against the tissue to extend the cutting end of the lancet past the sampling end of the test strip and into the tissue;

wherein the sample chamber opening moves relative to the lancet from a first position where the sample chamber opening extends past the cutting end of the lancet to a second position where the sample chamber opening is retracted relative to the cutting end of the lancet as the test strip bends during said forming the incision; and

sampling fluid from the incision by drawing fluid into the sample chamber opening of the test strip.

17. The method of claim 16, further comprising:

wherein the test strip includes a connector end located opposite the sample chamber opening, the lancet is attached to the test strip at the connector end;

wherein at the first position the test strip contacts along the entire length of the lancet; and

wherein at the second position a portion of the test strip between the sampling end and the connector end arches out of contact with the lancet.

18. A method, comprising:

providing a lancet integrated test strip that includes a lancet attached to a test strip, wherein a cutting end of the lancet extends proximal a sampling end of the test strip that includes a sample chamber opening;

forming an incision in tissue with the lancet integrated test strip;

wherein said forming the incision includes bending the test strip by pressing the sampling end of the test strip against the tissue to extend the cutting end of the lancet past the sampling end of the test strip and into the tissue;

wherein the cutting end of the lancet moves relative to the test strip from a first position where the sample chamber opening extends past the cutting end of the lancet to a second position where the cutting end of the lancet extends past the sample chamber opening as the test strip bends during said forming the incision; and

sampling fluid from the incision by drawing fluid into the sample chamber opening of the test strip.