Methods and apparatus for analyzing an analysis fluid

• US 7,931,864 B2
• Filed: 12/31/2009
• Issued: 04/26/2011
• Est. Priority Date: 08/11/2004
• Status: Expired due to Fees

• Current Assignee: Hans G. Kloepfer
• Original Assignee: Hans G. Kloepfer
• Inventors: Hafellner, Reinhard, Kloepfer, Thomas P., Heim, Jason, Kloepfer, Hans G.
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Mui; Christine T
• Application Number:
  US12/655,589
• Publication Number:
  US 20100183477A1
• Time in Patent Office: 481 Days
• Field of Search: 422/68.1, 422/50, 422/58, 422/55, 435/14, 435/4, 600/367
• US Class Current: 422/68.1
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A meter and test wand system is capable of cooperatively processing an analysis fluid and communicating results to a user. The system includes a meter case including a case front, a case front, a case front, a case bottom, a first case side member, and a second case side member. The first and second case side members connect the case front to case front. The first case side member has a longitudinal dimension between said case front and said case bottom and a latitudinal dimension between said case front and said case front. The first case side member includes a first case ridge; A test wand is capable of receiving an analysis fluid, and includes a cartridge including a cartridge ridge. The cartridge ridge is sized and shaped to matingly engage with said first case ridge to connect said test wand to said meter case.

Claims

1. A body fluid testing system comprising a test wand and a meter, the meter having a test wand opening including a side wall to process an analysis fluid, said test wand comprising:

a test strip having a proximal end and a distal end, said test strip containing a reagent and comprising a first layer having a first arm and a second, spaced layer defining a channel therebetween;

said test strip being capable of receiving the analysis fluid at the distal end; and

a test strip holder having a proximal end and a distal end;

said test strip holder comprising a base and a slot, such that when said test strip is inserted in said test strip holder, said arm of said first layer extends through said slot of said test strip holder;

said test strip holder being sized and shaped to be inserted in the test wand opening, the test wand opening and test strip being configured to engage each other to create a capillary gradient in the test strip for causing the fluid to flow in a proximal direction.

2. The body fluid testing system of claim 1 wherein the distal end has a surface to volume ratio, as said test wand is inserted into the test wand opening, the side wall of the test wand opening engages said first arm of said first layer, pulling said first arm and said first layer of said test strip in the proximal direction, to reduce the surface to volume ratio of the distal end, thereby increasing a capillary gradient, and thereby causing said analysis fluid to flow in the proximal direction to expose a portion of said reagent on said first layer that has reacted with the analysis fluid.

3. The body fluid testing system of claim 2, wherein said test strip holder further comprises a test strip retainer and a living hinge mechanism, said test strip retainer being connected to said base by said living hinge mechanism.

4. The body fluid testing system of claim 2, wherein said second layer comprises a second arm and a foot, said foot being located at the distal end of said test strip and said second arm being positioned to align with said first arm when said second layer is placed in the desired position above said first layer;

and said test strip holder further comprises upstanding side walls along each side of said base between said proximal end and said distal end, the distal end of said side walls having a ramped surface;

wherein, as said test wand is inserted into the test wand opening, the side wall of the test wand opening engages said first and second arms of said test strip, pulling said first and second arms and said first and second layers in the proximal direction, causing said foot of said second layer to engage said ramped surface of said side walls separating said second layer from said first layer, causing the analysis fluid to flow in the proximal direction to expose a portion of said reagent that has reacted with the analysis fluid.

5. The body fluid testing system of claim 4, wherein said test strip holder further comprises an optical path aperture, wherein, after said test wand is inserted in the test wand opening, the portion of said reagent that is above said optical path aperture has reacted with the analysis fluid.

6. The body fluid testing system of claim 2, wherein said second layer contains said reagent;

wherein, as said test wand is inserted into the test wand opening, the side wall of the test wand opening engages said arm of said first layer of said test strip, pulling said first arm and said first layer in the proximal direction, causing the analysis fluid to flow in the proximal direction to expose a portion of said reagent that has reacted with the analysis fluid.

7. The body fluid testing system of claim 6, wherein said test strip holder further comprises an optical path aperture, wherein, after said test wand is inserted in the test wand opening, the portion of said reagent above said optical path aperture has reacted with the analysis fluid.

8. The body fluid testing system of claim 1 wherein the test wand opening engages the test strip to separate the first and the second layers to thereby cause the surface to volume ratio of the distal end to decrease relative to the proximal end.

9. The body fluid testing system of claim 1 wherein said second layer further comprises a second arm and a foot, wherein the first and second layers are separable, and wherein the separation of the first and second layers facilitates removal of the analysis fluid from the reagent.

10. The body fluid testing system of claim 1 wherein the distal end includes a surface to volume ratio, and wherein the test wand opening of the meter is configured for moving the distal end of the test want in a proximal direction to reduce the surface to volume ratio of the distal end, thereby increasing a capillary gradient for causing the analysis fluid to move in a proximal direction.

11. The body fluid testing system of claim 1 wherein as the test wand is inserted into the test wand opening of the meter, the side wall of the test wand opening engages the first arm of the first layer, pulling the first arm and the first layer of the test strip in a proximal direction, thereby causing the analysis fluid to flow in the proximal direction to expose a portion of the reagent on the first layer that has reacted with the analysis fluid.

12. A test wand for use with a meter having a test wand opening including a side wall to process an analysis fluid, said test wand comprising:

a test strip having a proximal end and a distal end, said test strip containing a reagent and comprising a first layer having a first arm and a second layer spaced from the first and defining a channel therebetween;

said test strip being capable of receiving the analysis fluid at the distal end; and

a test strip holder having a proximal end and a distal end;

said test strip holder comprising a base and a slot, such that when said test strip is inserted in said test strip holder, said arm of said first layer extends through said slot of said test strip holder;

said test strip holder being sized and shaped to be inserted in the test wand opening, wherein, as said test wand is inserted into the test wand opening, the side wall of the test wand opening engages said first arm of said first layer, pulling said first arm and said first layer of said test strip in the proximal direction, causing said analysis fluid to flow in the proximal direction to expose a portion of said reagent on said first layer that has reacted with the analysis fluid, wherein said test strip holder further comprises a sample application pad and a wiper, said sample application pad being located on the distal side of said wiper;

wherein, as said test wand is inserted into the test wand opening, the side wall of the test wand opening engages said first arm of said first layer, pulling said first arm and said first layer in the proximal direction, causing first layer to pass over said wiper of said test strip holder, wiping said analysis fluid from said first layer to expose a portion of said reagent that has reacted with the analysis fluid.

13. The test wand of claim 12, wherein said test strip holder further comprises an optical path aperture, wherein, after said test wand is inserted in the test wand opening, the portion of said reagent above said optical path aperture has reacted with the analysis fluid.

14. The test wand of claim 12, wherein said test strip holder further comprises a protrusion, wherein, when said test strip is inserted in said test strip holder, said protrusion exerts a force on said test strip causing said test strip to push against said wiper.