Thin lance and test sensor having same

• US 6,561,989 B2
• Filed: 06/11/2001
• Issued: 05/13/2003
• Est. Priority Date: 07/10/2000
• Status: Expired due to Term

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Whitson, Robert C.
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): Fastovsky, Leonid M
• Application Number:
  US09/877,420
• Publication Number:
  US 20020004196A1
• Time in Patent Office: 701 Days
• Field of Search: 600/573, 600/583, 422/63, 606/182, 606/181
• US Class Current: 600/573
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150435 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 5/15113 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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 lance is provided for puncturing skin and producing a sample of blood. The lance comprises a spring having a first end and a second end disposed between a needle and a base wherein the first end of spring is coupled to the base and the second end of the spring is coupled to the needle.

Claims

1. A test sensor for use in the determination of the concentration of a chemical in blood, the test sensor comprising:

a front and a rear panel;

a substantially flat test chamber disposed between the front and rear panels having an inlet, the test chamber being adapted to collect a sample of blood through the inlet; and

a substantially flat lance coupled to one of the front and rear panels, the lance being adapted to puncture skin.

2. The test sensor of claim 1 wherein the lance includes:

a spring having a first end and a second end, the first end coupled to the test sensor; and

a needle coupled to the second end of the spring.

3. The test sensor of claim 1 wherein the lance includes:

a base;

a thin spring having a first end and a second end, the first end coupled to the base;

a thin, generally U-shaped body having an interior edge and an exterior edge, the second end of the thin spring coupled to the interior edge; and

a thin needle coupled to the exterior edge.

4. The test sensor of claim 1 wherein the test chamber includes a reagent, the reagent being adapted to produce an electrochemical reaction, the test sensor further comprising a pair of electrodes coupled to the test chamber.

5. The test sensor of claim 3 in combination with a sensor adapted to measure the concentration of a chemical in the blood.

6. The test sensor of claim 1 wherein the lance has a thickness of about 0.006 inch.

7. A lance comprising:

a substantially flat base;

a substantially flat spring having a first end and a second end, the first end of the spring being attached to the base;

a substantially flat, generally U-shaped body having an interior edge and an exterior edge, the interior edge of the U-shaped body coupled to the second end of the spring, the generally U-shaped body having two sides for receiving an external force providing movement to the U-shaped member; and

a substantially flat needle attached to the exterior edge of the U-shaped body;

wherein, the base, the spring, the U-shaped body, and the needle are made out of a single piece of a material.

8. The lance of claim 7 wherein the single piece of material is a metal.

9. The lance of claim 7 wherein the base, the spring, the U-shaped body, and the needle are approximately 0.006 inch thick.

10. The lance of claim 7 further comprising a substantially flat test sensor for use in the determination of the concentration of a chemical in blood, the base of the lance being attached to the substantially flat test sensor such that an inlet of the test sensor is disposed proximate the substantially flat needle.

11. A blood glucose monitoring system comprising:

a substantially flat test sensor having an inlet for receiving a blood sample;

a substantially flat lance having a substantially flat base, a substantially flat spring, and a substantially flat, generally U-shaped body, the spring having first and second end, the first end being attached the base, the U-shaped body having an interior edge attached to the second end of the spring and an exterior edge, the lace having a substantially flat needle outwardly extending from the exterior edge of the U-shaped body for puncturing a user'"'"'s skin; and

a forcing member providing movement to the needle of the lance in a first direction by contacting the U-shaped body, the spring retracting the flat lance in a second direction.

12. The system of claim 11 wherein the substantially flat, generally U-shaped body comprises two side portions for receiving a force from the force providing member.

13. The system of claim 11 wherein the substantially flat lance and the substantially flat test sensor are disposed in a disposable cap.

14. The system of claim 11 wherein the test sensor includes a reagent adapted to produce an electrochemical reaction indicative the concentration of glucose in the receive blood sample, the test sensor further comprising a pair of electrodes.

15. The system of claim 11 in combination with a device for measuring the concentration of the glucose in the blood.

16. The system of claim 11 wherein the substantially flat base, the substantially flat spring, the substantially flat, generally U-shaped body, and the a substantially flat needle are formed from a single piece of material.

17. The system of claim 16 wherein the material is metal.

18. The system of claim 11 wherein the substantially flat base, the substantially flat spring, the substantially flat, generally U-shaped body, and the a substantially flat needle are approximately 0.006 inch thick.