Test strip with integrated lancet

• US 8,636,672 B2
• Filed: 02/28/2007
• Issued: 01/28/2014
• Est. Priority Date: 02/28/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Neel, Gary, Caban, Allan Javier
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US11/711,621
• Publication Number:
  US 20080208078A1
• Time in Patent Office: 2,526 Days
• Field of Search: 600/583, 600/584
• 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 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• 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 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present disclosure provides methods and systems to collect blood from a patient using a lancet integrated with a test strip. The present disclosure provides integrated test strips having an integrated lancet, as well as meters for actuating the lancet integrated within a test strip. The analyte test strip comprises a first test strip substrate material and a second test strip substrate material. At least one test strip substrate material comprises an elongate cavity. The test strip further comprises a reaction test site for testing analyte concentrations in blood. The test strip further comprises at least one opening communicating with the at least one cavity.

Claims

1. An analyte test strip comprising:

a first test strip substrate having a bottom surface;

a second test strip substrate having a top surface;

a reaction test site located on at least one of the first substrate and the second substrate;

an elongate cavity extending between the bottom surface of the first substrate and the top surface of the second substrate and traversing the reaction test site;

a lancet having a pointed end and an opposite end configured to engage an actuation mechanism of an analyte meter, the lancet disposed in the elongate cavity;

the first and second test strip substrates mated to each other, sealing the cavity therebetween, wherein a proximal end of one of the first and the second substrates extends beyond a proximal end of the other of the first and the second substrates and is configured to engage an interface of the analyte meter to form an electrical connection between the test strip and the meter, and wherein the cavity extends to the proximal end of the other of the first and the second substrates;

an opening of the cavity disposed at one end of the test strip and positioned proximate to the reaction test site; and

a seal configured to seal the opening,

wherein the pointed end of the lancet is movable in and out of the opening and traversing the seal.

2. The test strip of claim 1, wherein the lancet comprises at least one of a biocompatible plastic and a biocompatible metal.

3. The test strip of claim 1, wherein the reaction test site comprises one or more enzymes selected to facilitate a reaction with glucose.

4. The test strip of claim 3, wherein the one or more enzymes comprise at least one of glucose oxidase and glucose dehydrogenase.

5. The test strip of claim 1, wherein the seal covering the opening is comprised of a thin film.

6. The test strip of claim 5, wherein the thin film is comprised of a polymer.

7. The test strip of claim 5, wherein the thin film is comprised of a latex.

8. The test strip of claim 5, wherein the thin film is comprised of a polyethylene.

12. The test strip of claim 1, wherein the pointed end of the lancet is configured to protrude a predetermined distance from the opening.

9. An analyte meter for monitoring a characteristic of a sample of blood, comprising:

a test strip interface for engaging a first end of a test strip, the test strip including;

a first test strip substrate having a bottom surface;

a second test strip substrate having a top surface;

a reaction test site located on at least one of the first substrate and the second substrate;

an elongate cavity extending between the bottom surface of the first substrate and the top surface of the second substrate and traversing the reaction test site;

a lancet having a pointed distal end opposite a proximal end, the proximal end configured to engage an actuation mechanism of an analyte meter, the lancet disposed in the elongate cavity;

the first and second test strip substrates mated to each other,

sealing the cavity therebetween, wherein a proximal end of one of the first and the second substrates extends beyond a proximal end of the other of the first and the second substrates at the first end of the test strip;

an opening of the cavity disposed at one end of the test strip;

a seal configured to seat the opening; and

the opening positioned proximate to the reaction site, wherein the distal end of the lancet is movable in and out of the opening and traversing the seal;

an actuation mechanism configured to engage the proximal end of the lancet and to advance the distal end of the lancet through the opening of the test strip;

a test strip interface configured to engage the proximal end of one of the first and the second substrates aired that extends beyond the other of the first and the second substrates to form an electrical connection between the test strip and the analyte meter, and

wherein the cavity extends to the proximal end of the other of the first and the second substrates; and

a meter for measuring the concentration of an analyte in a sample of blood.

10. The analyte meter of claim 9, wherein the actuation mechanism comprises a spring.

11. The analyte meter of claim 9, wherein the actuation mechanism comprises a motor.