Integrated analytical test element

• US 7,708,703 B2
• Filed: 03/27/2007
• Issued: 05/04/2010
• 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 N., Raney, Charles C.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/691,674
• Publication Number:
  US 20070191738A1
• Time in Patent Office: 1,134 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• 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 includes a connector end portion configured to connect to a meter and a sampling end portion having a sample chamber with a sample chamber opening where fluid is collected from the incision, wherein the test element is bendable between the connector end portion and the sample chamber opening to expose the incision forming member during formation of the incision;

a lancing mechanism comprising a holder to which the integrated device is coupled;

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

the holder having first and second stop surfaces that define the deflection cavity;

the integrated device being received in the deflection cavity of the holder with the sampling end portion positioned at the first stop surface and the connector end portion positioned at the second stop surface;

the test element being configured to bend in the deflection cavity over the length of the test element from the sampling end portion to the connector end portion; and

the first and second stop surfaces being obliquely angled in an opposite manner to limit the degree to which the length of the test element bends when the test element bends in the deflection cavity.

2. 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.

3. The apparatus of claim 1, wherein:

the incision forming member has a cutting end; 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.

4. The apparatus of claim 1, further comprising:

the test element further including

an electrode system including contact pads at the connector end portion, electrodes in the sample chamber, and electrode traces operatively coupling the electrodes to the contact pads, and

the electrode traces being configured to bend as the test element is bent; and

the stop surfaces being configured to prevent excessive bending of the electrode traces.

5. The apparatus of claim 1, further comprising:

a pull type protective sheet; and

the incision forming member being sandwiched between the pull type protective sheet and the test element to prevent bending of the test element prior to use.

6. The apparatus of claim 1, further comprising:

a protective band wrapped around the test element and the incision forming member to prevent the test element from bending prior to use.

7. The apparatus of claim 1, in which the incision forming member includes a ridge that forms a u-shaped channel.

8. 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 and a connector end;

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

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

the holder having first and second stop surfaces that define the deflection cavity;

the test element being received in the deflection cavity of the holder with the sampling end positioned at the first stop surface and the connector end positioned at the second stop surface;

the test element being configured to bend over the length of the test element from the sampling end to the connector end;

the first and second stop surfaces being obliquely angled in an opposite manner to limit the degree to which the length of the test element bends when the test element bends in the deflection cavity;

wherein the sampling end of the test element contacts the first stop surface when the test element is bent to the second state; and

wherein the connector end of the test element contacts the second stop surface when the test element is bent to the second state.

9. The apparatus of claim 8, further comprising:

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

10. The apparatus of claim 8, further comprising:

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

11. 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 includes a connector end portion configured to connect to a meter and a sampling end portion having a sample chamber with a sample chamber opening where fluid is collected from the incision, wherein the test element is bendable between the connector end portion and the sample chamber opening to expose the incision forming member during formation of the incision;

a lancing mechanism comprising a holder to which the integrated device is coupled;

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

the holder having first and second stop surfaces that define the deflection cavity;

the integrated device being received in the deflection cavity of the holder with the sampling end portion positioned at the first stop surface and the connector end portion positioned at the second stop surface;

the test element being configured to bend in the deflection cavity over the length of the test element from the sampling end portion to the connector end portion;

the first and second stop surfaces being obliquely angled in an opposite manner to limit the degree to which the length of the test element bends when the test element bends in the deflection cavity;

the test element further including

an electrode system including contact pads at the connector end portion, electrodes in the sample chamber, and electrode traces operatively coupling the electrodes to the contact pads, and

the electrode traces being configured to bend as the test element is bent;

the stop surfaces being configured to prevent excessive bending of the electrode traces;

a meter in which the lancing mechanism is incorporated, the meter being operatively coupled to the contact pads of the test element; and

the incision forming member including a test strip attachment portion attached to the test element at the contact end portion directly underneath the contact pads for stiffening the contact pads so that the contact pads remain coupled with the meter when the test element is bent.