Cartridge with lancets and testing device using the cartridge

• US 8,971,982 B2
• Filed: 03/08/2005
• Issued: 03/03/2015
• Est. Priority Date: 01/18/2005
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US11/073,736
• Publication Number:
  US 20060157362A1
• Time in Patent Office: 3,647 Days
• Field of Search: 600/583, 600/584, 600/347, 600/365, 606/181, 606/182
• US Class Current: 600/347
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence

Abstract

Cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device adjacent or against a user'"'"'s skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user'"'"'s skin, and rotating the cartridge to another position. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Claims

1. A combination of a cartridge and a testing device, the combination comprising:

a cartridge comprising;

a plurality of lancet needles movably mounted to a disk-shaped body;

a plurality of test strips arranged on the disk-shaped body; and

a mechanism allowing the cartridge to be mounted to the testing device,

wherein, when installed in the testing device, the cartridge is sized and configured to extend outside of a body of the testing device such that an outer peripheral portion of the cartridge and portions of electrical contacts of the test strips exposable to a user'"'"'s blood drop are visible and accessible while the testing device is resting on a horizontal surface, such that the portions of the electrical contacts exposed to a user'"'"'s blood drop extend into a testing area and are visible and accessible to a user from a position above the testing device,

wherein each of the plurality of lancet needles is generally radially oriented and moves along a generally linear path, and

wherein each of the plurality of test strips is generally radially oriented.

2. The combination of claim 1, wherein the mechanism allowing the cartridge to be mounted to the testing device comprises an opening.

3. The combination of claim 1, wherein each of the plurality of lancet needles moves along a generally linear path without rotating.

4. The combination of claim 1, further comprising a plurality of springs, each spring having one end coupled to one of the plurality of lancet needles.

5. The combination of claim 1, wherein the cartridge comprises a generally circular shape.

6. The combination of claim 1, wherein the cartridge comprises a generally circular shape having an outer diameter of no greater than about 2 inches.

7. The combination of claim 1, wherein the cartridge comprises a generally circular shape having a thickness of no greater than about 0.25 inches.

8. The combination of claim 1, further comprising a ring-shaped member, wherein each of the plurality of lancet needles is movably mounted to the ring-shaped member.

9. The cartridge of claim 1, wherein the plurality of test strips are non-movably mounted to an upper surface of the disk-shaped body.

10. The cartridge of claim 1, wherein the disk-shaped body comprises a thickness of less than about 0.10 inches.

11. A method of puncturing a surface of skin using the combination of claim 1, the method comprising:

installing the cartridge on the testing device;

placing a finger of a user on a portion of the outer peripheral portion of the cartridge;

triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user'"'"'s skin; and

rotating the cartridge to another position.

12. A combination comprising:

a cartridge comprising a planar disk-shaped body, a plurality of radially oriented lancet needles mounted to a member that is fixed to an upper surface of the disk-shaped body, a plurality of test strips arranged on the upper surface of the disk-shaped body, and a plurality of springs;

each spring being structured and arranged to at least one of;

move one of the plurality of lancet needles towards an extended position; and

move one of the plurality of lancet needles towards a retracted position;

a testing device,

wherein the cartridge is structured and arranged to be removably mountable to the testing device, and

wherein, when installed in the testing device, the cartridge is sized and configured to extend outside of a body of the test device such that an outer peripheral portion of the cartridge and portions of electrical contacts of the test strips exposable to a user'"'"'s blood drop are visible and accessible while the testing device is resting on a horizontal surface, such that the portions of the electrical contacts exposed to a user'"'"'s blood drop extend into a testing area and are visible and accessible to a user from a position above the testing device.

13. The combination of claim 12, wherein the planar disk-shaped body comprises a center opening and a plurality of radially oriented guide slots, wherein the plurality of radially oriented lancet needles are movable along a generally linear path without substantially rotating, and wherein the center opening allows the cartridge to be removably mounted to the test device.

14. A method of puncturing a surface of skin using the combination of claim 12, the method comprising:

installing the cartridge on the testing device;

placing a finger of a user on a portion of the outer peripheral portion of the cartridge;

triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user'"'"'s skin; and

rotating the cartridge to another position.

15. A testing device comprising:

a housing; and

a cartridge comprising;

a plurality of lancet needles radially oriented and movably mounted to one side of a disk-shaped body;

the body having test strips integrally formed therein; and

a plurality of springs,

wherein the cartridge is movably mounted within the housing, and

wherein, when installed in the housing, the cartridge is sized and configured to extend outside of a body of the housing such that an outer peripheral portion of the cartridge and portions of electrical contacts of the test strips exposable to a user'"'"'s blood drop are visible and accessible while the housing is resting on a horizontal surface, such that the portions of the electrical contacts exposed to a user'"'"'s blood drop extend into a testing area and are visible and accessible to a user from a position above the housing.

16. The testing device of claim 15, wherein the cartridge is generally disk-shaped and comprises a center opening which is rotatably mounted about a hub arranged within the housing.

17. The testing device of claim 15, wherein the plurality of lancet needles are movably mounted to a member that is fixed to the disk-shaped body.

18. The testing device of claim 15, wherein the cartridge is removably mounted to the housing.

19. The testing device of claim 15, wherein the housing comprises a door which can be opened to remove the cartridge.

20. A glucose meter comprising:

a housing;

a cartridge comprising a plurality of lancet needles radially oriented and movably mounted to one side of a disk-shaped body having test strips integrally formed therein and slots;

a plurality of radially movable projecting portions extending through the slots in the disk-shaped body so as to extend to an opposite side of the disk-shaped body, each projecting portion being movable with one of the lancet needles;

the cartridge being movably and removably mounted within the housing;

a mechanism which retains the cartridge in at least one rotational position; and

a device which allows a user to rotate the cartridge between a plurality of positions,

wherein, when installed in the housing, the cartridge is sized and configured to extend outside of a body of the housing such that an outer peripheral portion of the cartridge and portions of electrical contacts of the test strips exposable to a user'"'"'s blood drop are visible and accessible while the housing is resting on a horizontal surface, such that the portions of the electrical contacts exposed to a user'"'"'s blood drop extend into a testing area and are visible and accessible to a user from a position above the housing.

21. The glucose meter of claim 20, wherein the housing comprises a door which can be opened to remove the cartridge.

22. The glucose meter of claim 20, wherein the mechanism which retains the cartridge in at least one rotational position comprises a deflecting member.

23. The glucose meter of claim 20, wherein the device which allows a user to rotate the cartridge between a plurality of positions comprises a motor.

24. The glucose meter of claim 20, further comprising an alignment mechanism allowing the cartridge to be initially mounted within the housing in only a single position.

25. The glucose meter of claim 20, further comprising one of a notch and a groove which ensures that the cartridge is mounted to the housing in a predetermined position.

26. The glucose meter of claim 20, further comprising a locking mechanism preventing rotation of the cartridge once the cartridge has rotated in the housing to a locking position.

27. A method of puncturing a surface of skin using the glucose meter of claim 20, the method comprising:

installing the cartridge on the housing;

placing a finger of a user on a portion of the outer peripheral portion of the cartridge;

triggering the glucose meter so that one of the plurality of lancet needles is caused to penetrate the user'"'"'s skin; and

rotating the cartridge to another position.