Methods and apparatus for analyzing an analysis fluid

• US 20060034728A1
• Filed: 08/11/2004
• Published: 02/16/2006
• Est. Priority Date: 08/11/2004
• Status: Active Grant

• Current Assignee: Hans Kloepfer
• Original Assignee: Hans Kloepfer
• Inventors: Kloepfer, Hans G., Hafellner, Reinhard, Kloepfer, Thomas P., Heim, Jason
• Granted Patent: US 7,695,676 B2
• Time in Patent Office: Days
• US Class Current: 422/68.100
• 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 back, a case top, 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 back. The first case side member has a longitudinal dimension between said case top and said case bottom and a latitudinal dimension between said case front and said case back. 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 meter and test wand system, the system being capable of cooperatively processing an analysis fluid and communicating results to a user, comprising:

a meter case comprising a case front, a case back, a case top, a case bottom, a first case side member, and a second case side member;

said first and second case side members connecting said case front to case back;

said first case side member having a longitudinal dimension between said case top and said case bottom and a latitudinal dimension between said case front and said case back;

said first case side member including a first case ridge;

a test wand capable of receiving an analysis fluid, said test wand comprising a cartridge including a cartridge ridge;

said cartridge ridge being sized and shaped to matingly engage with said first case ridge to connect said test wand to said meter case.

2. The meter and test wand system of claim 1, wherein said first case ridge extends longitudinally along said first case side member such that multiple test wands can be connected to said meter case by connecting said cartridge ridge of each test wand to said first case ridge.

3. The meter and test wand system of claim 1, wherein said first case side member includes a first case ridge and a second case ridge such that multiple test wands can be connected to said meter case by connecting said cartridge ridge of each test wand to at least one of said first case ridge and said second case ridge.

4. The meter and test wand system of claim 3, wherein said first case side member includes a first case ridge, a second case ridge, a third case ridge and a fourth case ridge, each of said case ridges extending longitudinally along said first case side member, said first case ridge being closest to said case front, said second case ridge being second closest to said case front, said fourth case ridge being closest to said case back, and said third case ridge being second closest to said case back;

and said cartridge includes a first cartridge ridge and a second cartridge ridge, said first and second cartridge ridges being sized and shaped to matingly engage with one of said first and second case ridges, said second and third case ridges, and said third and fourth case ridges.

5. The meter and test wand system of claim 4, wherein two test wands can be connected latitudinally next to each other by connecting said first and second cartridge ridges of one test wand to said first and second case ridges, and connecting said first and second cartridge ridges of the other test wand to said third and fourth case ridges.

6. The meter and test wand system of claim 1, wherein said second case side member has a longitudinal dimension between said case top and said case bottom and a latitudinal dimension between said case front and said case back, and said second case side member includes a first case ridge, said cartridge ridge being sized and shaped to matingly engage with said first case ridge to connect said test wand to said meter case.

7. 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;

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 of the meter;

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.

8. The test wand of claim 7, 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.

9. The test wand of claim 7, wherein said test strip further comprises a second layer comprising 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.

10. The test wand of claim 9, 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.

11. The test wand of claim 7, wherein said test strip further comprises a second layer containing 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.

12. The test wand of claim 11, 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.

13. The test wand of claim 7, 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.

14. The test wand of claim 13, 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.

16. The test wand of claim 13, 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.

17. A method of processing an analysis fluid using a test strip contained in a test strip holder, the test strip having a proximal end and a distal end, the test strip containing a reagent and comprising a first layer having a first arm;

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

the test strip holder comprising a base and a slot;

the method comprising the steps of;

placing the analysis fluid on the distal end of a test strip;

extending the first arm of the first layer through the slot of the test strip holder;

allowing the reagent to react with the analysis fluid;

inserting the test wand holder into a test wand opening having side walls;

engaging the first arm against the side walls of the test wand opening;

pulling the first arm and the first layer of the test strip in the proximal direction,

causing the analysis fluid to flow in the proximal direction; and

exposing a portion of the reagent on the first layer that has reacted with the analysis fluid.

18. The method of claim 17, wherein the test strip further comprises a second layer comprising a second arm and a foot, the foot being located at the distal end of the test strip and the second arm being positioned to align with the first arm when the second layer is placed in the desired position above the first layer;

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

extending the second arm of the second layer through the slot of the test strip holder;

engaging the second arm against the side walls of the test wand opening;

pulling the second arm and the second layer of the test strip in the proximal direction,

causing said foot of said second layer to engage said ramped surface of said side walls; and

separating said second layer from said first layer.

19. The method of claim 17, wherein the test strip further comprises a second layer containing said reagent;

further comprising the steps of;

pulling the first layer in the proximal direction off the distal end of the second layer, and

exposing a portion of the reagent on the distal end of the second layer that has reacted with the analysis fluid.

20. The method of claim 17, wherein the test strip holder further comprises a sample application pad and a wiper, the sample application pad being located on the distal side of the wiper;

further comprising the steps of;

causing the first layer to pass over the wiper of the test strip holder, and

wiping the analysis fluid from the first layer.

21. The method of claim 20, wherein the test strip holder further comprises a protrusion;

further comprising the steps of;

exerting a force on the test strip that causes the test strip to push against the wiper.

22. A meter for analyzing an analysis fluid taken on a test wand, said meter comprising:

an optics module comprising a light source and a light detector, said light source generating a light beam that passes through the test wand and onto said detector;

an output converter connected to the output of said detector to convert the output of said detector for further processing;

a microprocessor connected to said optics module and said output converter, for controlling said light source and processing the output of said detector;

a display connected to said microprocessor for communicating the results of the analysis;

a button connected to said microprocessor for providing input to said microprocessor; and

a serial interface connected to said microprocessor for transmitting information to and from said microprocessor.

23. The meter of claim 22, wherein said light source is a narrow band LED.

24. A visual backup system for a meter that analyzes an analysis fluid taken on a test wand, said visual backup system comprising:

a test wand opening sized and shaped for insertion of the test wand;

a color wheel containing various shades of color covering the spectrum of colors of the reacted test wand, and a plurality of apertures spaced circumferentially around said color wheel;

wherein, when the test wand is placed in said test wand opening, one of said plurality of apertures on said color wheel can be placed over the test wand opening such that the test wand is visible through said one of said plurality of apertures.

25. The visual backup system of claim 24 wherein said color wheel is separated into a plurality of sectors, each of said sectors being a different color, one of said plurality of apertures being located in each sector.

26. The visual backup system of claim 24 wherein said color wheel is a continuum of color with a discontinuity where the start and finish of the continuum meet.

27. The visual backup system of claim 24 further comprising a light pipe comprising a light entrance aperture in the meter, a light exit aperture in said test wand opening, and a light transmission path between said light entrance aperture and said light exit aperture.

28. A method for performing a visual backup for a meter that analyzes an analysis fluid taken on a test wand using a color wheel having a plurality of apertures, and containing various shades of color covering the spectrum of colors of the reacted test wand, said method comprising the steps of:

reacting the analysis fluid with a reagent on the test wand;

inserting the test wand in a test wand opening;

placing one of the plurality of apertures on the color wheel over the test wand opening,

looking through the aperture over the test wand opening;

rotating the color wheel until the aperture surrounded by the color most closely matching the color of the reacted test wand is over the test wand opening;

selecting the portion of the color wheel with the aperture surrounded by the color most closely matching the color of the reacted test wand; and

checking the characteristics the selected portion of the color wheel.

29. The method of claim 28 further comprising the steps of:

introducing light into a light pipe entrance aperture to shine through a light pipe exit aperture in the test wand opening under the color wheel.

30. A method for analyzing an analysis fluid collected on a test wand using a handheld meter, said method comprising the steps of:

inserting the test wand in a test wand opening of the meter;

drawing the analysis fluid across a reagent film on the test wand,

exposing the reagent film to the analysis fluid;

further drawing the analysis fluid from an exposed portion of the reagent film;

emitting a light beam from a light source in the handheld meter onto the exposed portion of the reagent film to a detector in the handheld meter to obtain a detector reading; and

measuring a characteristic of the exposed portion of the reagent film using the detector reading.

31. The method of claim 30 wherein the measuring step is performed using a transmittance measurement through the exposed portion of the reagent film.

32. The method of claim 31 wherein the drawing steps are performed using a capillary force.

33. The method of claim 31 wherein the test wand comprises an upper transparent panel, a lower transparent panel and an optical path aperture, further comprising the steps of:

separating the upper transparent panel from the lower transparent panel to create a capillary force;

drawing the analysis fluid over the reagent film and from the exposed portion of the reagent film using the capillary force;

measuring a characteristic of the exposed portion of the reagent film using a transmittance measurement through the optical path aperture, the upper transparent panel, and the lower transparent panel.

34. The method of claim 33 wherein the test wand further comprises side walls having ramped shaped distal ends, and the upper transparent panel further comprises a pair of latitudinally extending feet, wherein the separating steps comprises the steps of:

engaging the latitudinally extending feet of the upper transparent panel on the ramped shaped distal ends of the side walls.

35. The method of claim 31 wherein the test wand comprises an upper panel, a lower transparent panel and an optical path aperture, further comprising the steps of:

sliding the upper panel over the lower transparent panel beyond the optical path aperture to create a capillary force;

drawing the analysis fluid over the reagent film and from the exposed portion of the reagent film using the capillary force;

measuring a characteristic of the exposed portion of the reagent film using a transmittance measurement through the optical path aperture and the lower transparent panel.

36. The method of claim 31 wherein the test wand comprises a panel, a wiper and an optical path aperture, further comprising the steps of:

sliding the panel over the wiper to form the exposed portion of the reagent film;

measuring a characteristic of the exposed portion of the reagent film using a transmittance measurement through the optical path aperture and the panel.