INTEGRATED ANALYTICAL TEST ELEMENT

• US 20070191738A1
• Filed: 03/27/2007
• Published: 08/16/2007
• 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: Roe, Steven, Raney, Charles
• Granted Patent: US 7,708,703 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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. An apparatus, comprising:

an integrated lancing test device comprising

an incision forming member configured to form an incision in tissue, and

a test element attached to the incision forming member for testing fluid from the incision, wherein the test element is bendable to expose the incision forming member during formation of the incision; and

a lancing mechanism comprising a holder to which the integrated device is coupled, the holder comprising one or more stops to prevent excessive bending of the test strip during lancing.

2. The apparatus of claim 1, wherein:

the holder defines a slot in which the integrated device is received;

the holder defines a deflection cavity in which the test element bends;

the stops comprise opposing surfaces that are obliquely angled in an opposite manner for supporting the test element when bent.

3. The apparatus of claim 1, wherein:

the incision forming member comprises means for forming the incision in tissue;

the test element comprises means for testing the fluid; and

the holder comprises means for preventing excessive bending of the test strip.

4. The apparatus of claim 1, wherein:

the incision forming member has a cutting end;

the test element has a sampling end where fluid is collected; and

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 end extends past the sampling end of the test element to form the incision in the tissue.

5. An apparatus, comprising:

an incision forming member having a cutting end configured to form an incision in tissue;

a test element attached to the incision forming member to test fluid from the incision;

the test element having a sampling end with a sample opening through which the fluid is collected;

the test element being 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; and

a holder comprising one or more stops to prevent excessive bending of the test element during lancing.

6. The apparatus of claim 5, wherein:

the holder defines a slot in which the test element is received;

the holder defines a deflection cavity in which the test element bends;

the stops comprise opposing surfaces that are obliquely angled in an opposite manner for supporting the test element when bent.

7. The apparatus of claim 5, further comprising:

a lancing mechanism coupled to the holder for firing the incision forming member.

8. The apparatus of claim 5, further comprising:

means for preventing excessive bending of the test element during bending, wherein the means for preventing excessive bending comprises the holder.

9. An apparatus, comprising:

an incision forming member having a cutting end configured to form an incision in tissue;

a test element attached to the incision forming member to test fluid from the incision;

the test element having a sampling end with a sample opening through which the fluid is collected;

the test element being 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; and

a lancing mechanism configured to fire the incision forming member.

10. The apparatus of claim 9, further comprising

means for preventing excessive bending of the test element during bending.

11. The integrated device of claim 9, wherein the means for preventing excessive bending comprises a holder with one or more stops.

12. The apparatus of claim 9, further comprising:

a holder comprising one or more stops to prevent excessive bending of the test element during lancing.

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; and

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

14. The method of claim 13, further comprising:

analyzing the fluid from the incision with the test strip.

15. The method of claim 13, further comprising:

removing the lancet from the incision.

16. The method of claim 15, wherein said removing the lancet from the incision occurs before said sampling the fluid.

17. The method of claim 13, further comprising:

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

18. The method of claim 13, 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.

19. The method of claim 13, 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.