Analyte test device

• US 7,299,081 B2
• Filed: 06/15/2004
• Issued: 11/20/2007
• Est. Priority Date: 06/15/2004
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Laboratories
• Inventors: Nicolaisen, Andrea, Mace, Chad Harold, Dehart, Damon H.
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Mallari; Patricia C.
• Application Number:
  US10/868,575
• Publication Number:
  US 20050277850A1
• Time in Patent Office: 1,253 Days
• Field of Search: 204/403.02
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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

Abstract

An analyte test device is constructed as an integrated, single-use, disposable cartridge which can be releasably installed into a compatible analyte test monitor. In use, the device can be used in conjunction with the monitor to lance the skin of a patient to create a blood sample and, in turn, calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base and a cover which are affixed together to create a test cartridge which has a substantially flat and low profile design. A lancet carrier is disposed between the base and the cover and includes a anchor fixedly mounted on the base and a lancet support member which is slidably mounted on the base, the anchor and the lancet support member being connected by a spring. A lancet is removably mounted on the lancet support member is disposed directly beneath an analyte test strip which secured to the underside of the cover. In another embodiment, the device includes a cylindrical housing with an open top end and an open bottom end. A spring biased lancet is slidably mounted within the cylindrical housing. An analyte test strip is fixedly mounted within the cylindrical housing and is disposed at an acute angle relative to the lancet.

Claims

1. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte meter, said unitary, disposable cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end, and a read end,

(b) a cover secured to the base, whereby a substantially enclosed volume is formed, the cover including a top surface, a bottom surface, a front end and a rear end,

(c) a lancet carrier disposed between the base and the cover in the substantially enclosed volume, the lancet carrier comprising a spring, the spring having a first end and a second end, the first end of the spring being fixedly coupled to the base, the second end of the spring capable of displacement relative to the first end,

(d) a lancet removably mounted on the lancet carrier, and

(e) an analyte test strip disposed between the base and the cover in the substantially enclosed volume, the analyte test strip having a first end, a second end and a plurality of electrodes, wherein the cover includes a window through which the plurality of electrodes is externally accessible, and

(f) a skin receiving surface formed into the front end of said base in the form of an arcuate notch that extends inward from the front end of the base.

3. The unitary, disposable test cartridge as claimed in claim 1 wherein the lancet comprises:

(a) a tab adapted to be releasably retained on the lancet support member, and

(b) a sharpened needle formed onto the tab.

2. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte meter, said unitary, disposable cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end, and a read end,

(b) a cover secured to the base, whereby a substantially enclosed volume is formed, the cover including a top surface, a bottom surface, a front end and a rear end,

(c) a lancet carrier disposed between the base and the cover in the substantially enclosed volume, the lancet carrier comprising a spring, the spring having a first end and a second end, the first end of the spring being fixedly coupled to the base, the second end of the spring capable of displacement relative to the first end,

(d) a lancet removably mounted on the lancet carrier, and

(e) an analyte test strip disposed between the base and the cover in the substantially enclosed volume, the analyte test strip having a first end, a second end and a plurality of electrodes, wherein the cover includes a window through which the plurality of electrodes is externally accessible, and

(f) wherein an anchor is formed onto the first end of the spring, and

(g) wherein the anchor is fixedly secured to the base, and

(h) wherein a lancet support member is formed onto the second end of the spring, the lancet support member being slidably mounted on the base and capable of linear displacement relative to the anchor.

4. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte meter, said unitary, disposable cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end, and a read end,

(b) a cover secured to the base, whereby a substantially enclosed volume is formed, the cover including a top surface, a bottom surface, a front end and a rear end,

(c) a lancet carrier disposed between the base and the cover in the substantially enclosed volume, the lancet carrier comprising a spring, the spring having a first end and a second end, the first end of the spring being fixedly coupled to the base, the second end of the spring capable of displacement relative to the first end,

(d) a lancet removably mounted on the lancet carrier, and

(e) an analyte test strip disposed between the base and the cover in the substantially enclosed volume, the analyte test strip having a first end, a second end and a plurality of electrodes, wherein the cover includes a window through which the plurality of electrodes is externally accessible, and

(f) wherein said analyte test strip is adapted to be retained against the cover, and

(g) wherein the cover is shaped to define an opening along its front end through which a portion of the first end of the analyte test strip is externally visible.

5. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte test meter, said unitary disposable test cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end and a rear end,

(b) a lancet removably mounted on the base,

(c) an analyte test strip mounted on the base over the lancet, the analyte test strip comprising a first end, a second end and a plurality of electrodes, and

(d) a housing, the housing including a top surface, a bottom surface, a front end, a rear end and a pair of sidewalls that together define a substantially enclosed interior cavity, the interior cavity being sized and shaped to receive the base, the lancet and the analyte test strip, wherein a window is formed into the top surface of the housing through which window the plurality of electrodes is externally accessible.

6. The unitary, disposable test cartridge as claimed in claim 5 wherein the cartridge has a substantially flat, low profile design.

7. The unitary, disposable test cartridge as claimed in claim 6 wherein the top and bottom surfaces of the housing are flat.

8. The unitary, disposable test cartridge as claimed in claim 5 wherein an opening is formed into the front end of the housing, the opening being in communication with the interior cavity.

9. The unitary, disposable test cartridge as claimed in claim 8 wherein a skin receiving surface is formed into the front end of the base immediately surrounding the opening.

10. The unitary, disposable test cartridge as claimed in claim 5 wherein a shallow recess is formed into the top surface of the base, the shallow recess being sized and shaped to receive the lancet.

11. The unitary, disposable test cartridge as claimed in claim 5 wherein a spring is integrally formed into the base, the spring including a first end and a second end.

12. The unitary, disposable test cartridge as claimed in claim 11 wherein the first end of the spring is fixed in place and wherein the second end of the spring is capable of displacement relative to the first end of the spring.

13. The unitary, disposable test cartridge as claimed in claim 12 wherein the lancet is mounted on the second end of the spring.

14. The unitary, disposable test cartridge as claimed in claim 13 wherein the lancet is substantially flat and includes a sharpened needle.

15. An analyte test device which is adapted to be removably coupled to a compatible analyte test meter, said analyte test device comprising:

(a) a housing shaped to define an interior cavity,

(b) a lancet slidably mounted within the interior cavity of said housing, said lancet comprising a sharpened tip, the sharpened tip being adapted to selectively penetrate outside of the interior cavity of said housing, and

(c) an analyte test strip disposed within the interior cavity of said housing at an acute angle relative to said lancet, said analyte test strip comprising a first end, a second end and a plurality of electrodes, and

(d) wherein said housing includes a generally cylindrical sidewall which defines the interior cavity, the sidewall comprising an inner surface, an outer surface, an open bottom end and an open top end, and

(e) wherein said analyte test strip is fixedly mounted onto the inner surface of the sidewall, the first end of said analyte test strip being spaced in from the open bottom end of said housing, and

(f) wherein a needle support is integrally formed onto the inner surface of said housing, the needle support being shaped to define a longitudinal bore which is sized and shaped to receive at least a portion of said lancet, and

(g) further comprising a spring for resiliently urging said the tip of said lancet away from the open bottom end of said housing, said spring including a first end and a second end, and

(h) further comprising a cap, said cap being fixedly mounted on said lancet, and

(i) wherein the spring is mounted axially over the lancet with the first end of the spring disposed against the needle support in the housing and the second end of the spring disposed against the cap.