Consolidated body fluid testing device and method

• US 20030109777A1
• Filed: 12/06/2002
• Published: 06/12/2003
• Est. Priority Date: 12/07/2001
• Status: Active Grant

• Current Assignee: Hans Kloepfer
• Original Assignee: Micronix, Inc.
• Inventors: Roach, Charles W., Kloepfer, Hans G., Thomeczek, Charles, Hafellner, Reinhard
• Granted Patent: US 6,840,912 B2
• Time in Patent Office: Days
• US Class Current: 600/367
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150824 by visual feedback
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid.

Claims

1. A body fluid testing device comprising:

a body member

a tissue penetrator carried by the body member

a test strip holder carried by the body member, and

a test strip carried by the test strip holder, the test strip being capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid.

2. The testing device of claim 1, further comprising a cleansing member carried by the body member for cleansing a tissue area to be penetrated by the tissue penetrator.

3. The testing device of claim 1 further comprising a pressure inducing member carried by the body member, the pressure inducing member being capable of inducing pressure on a tissue site penetrated by the penetrating member for inducing an enhanced flow of fluid from the penetrated body tissue site.

4. The testing device of claim 3 wherein the body member includes a hand engaging portion having a gripping surface.

5. The testing device of claim 3 wherein the body member includes a first end, a second end, and a hand engaging surface disposed between the first and second ends.

6. The testing device of claim 5 wherein the tissue penetrator is axially movable between a retracted and an extended position, and includes a biasing member for biasing the tissue penetrator into the extended position.

7. The testing device of claim 6 wherein tissue penetrator includes an actuator for retaining the tissue penetrator in the retracted position, and upon activation by the user, for releasing the tissue penetrator to permit it to move into the extended position.

8. The testing device of claim 6, further comprising a cleansing member carried by the body member for cleansing a body tissue area to be penetrated by the tissue penetrator.

9. The testing device of claim 8 wherein the cleansing member includes an aperture, and the penetrator is disposed adjacent the first end of the body portion and is extendable through the aperture in the cleansing member as it moves from its retracted position to its axially extended position.

10. The testing device of claim 9 wherein the tissue penetrator includes a penetrating tip, the penetrating tip being disposed axially inwardly of an axially outer surface of the cleansing member when the tissue penetrator is in the retracted position to prevent engagement of the penetrating tip with body tissue when the cleansing member is cleansing the tissue.

11. The testing device of claim 9 wherein the tissue penetrator includes a depth adjuster for permitting the user to adjust the axial distance traveled by the tissue penetrator between its retracted and extended positions.

12. The testing device of claim 8 wherein the cleansing member is disposed adjacent to the first end of the body member, and includes a cleaner containing pad for cleaning the tissue area to be penetrated by the tissue penetrator.

13. The testing device of claim 8 wherein the pressure inducing member comprises a cap member disposed adjacent the first end of the body member, the cap member being hingedly coupled to the body member.

14. The testing device of claim 13 wherein the cap member is movable between a closed position wherein the cleansing member is covered by the cap member, and an opened position.

15. The testing device of claim 14 wherein the cap member includes a cap portion disposed generally co-axially with the body member when the cap member is in the closed position, the cap portion including a tissue engaging rim defining an axially inwardly extending cavity.

16. The testing device of claim 9 wherein the body fluid to be tested comprises mammalian blood.

17. The testing device of claim 2 wherein the body member includes a first end and a second end, the first end includes a cleansing member receiver for receiving the cleansing member.

18. The testing device of claim 17 wherein the cleansing member is generally toroidal and defines an axially extending aperture through which the tissue penetrator can pass.

19. The testing device of claim 18 wherein the tissue penetrator is disposed adjacent to the first end of the body member, and is axially movable between an extended position wherein a portion of the tissue penetrator extends through the axially extending aperture of the cleansing member receiver, and a retracted position.

20. The testing device of claim 19 where the tissue penetrator includes a penetrating tip, the penetrating tip being disposed axially inwardly of an axially outer surface of the cleansing member when the tissue penetrator is in the retracted position to prevent engagement of the penetrating tip with tissue when the cleansing member is cleansing tissue.

21. The testing device of claim 20 wherein the test strip holder is disposed adjacent to the second end of the body member, and wherein the test strip holder includes a test strip receiver for receiving the test strip, and a test strip retainer for retaining the test strip on the test strip receiver.

22. The testing device of claim 20 further comprising a cap member hingedly coupled to the first end of the body member, the cap member being movable between a closed position for enclosing the cleansing member and open position for exposing the cleansing member.

23. The testing device of claim 22 wherein the cap member includes a living hinge for hingedly coupling the cap member to the first end of the body member.

24. The testing device of claim 1 wherein the tissue penetrator is axially movable between a retracted and an extended position, and includes a biasing member for biasing the tissue penetrator into the extended position, the tissue penetrator further including an actuator for retaining the tissue penetrator in the retracted position, and releasing the tissue penetrator upon activation by the user, to move into the extended position.

25. The testing device of claim 24, further comprising a cleansing member carried by the body member and having an axially outer cleansing surface for cleansing a body tissue area to be penetrated by the tissue penetrator, wherein the tissue penetrator includes a penetrating tip, the penetrating tip being disposed axially inwardly of the axially outer cleansing surface of the cleansing member when the tissue penetrator is in the retracted position to prevent engagement of the penetrating tip with body tissue when the cleansing surface is engaging the tissue.

28. The testing device of claim 1 wherein the test strip holder includes a test strip receiver for receiving the test strip, and a test strip retainer for retaining the test strip on the test strip receiver.

29. The testing device of claim 28 wherein the test strip holder includes a hinge for hingedly coupling the test strip receiver to the test strip retainer.

30. The testing device of claim 28 wherein at least one of the test strip receiver and test strip retainer arc positioned in a spaced relation from the test strip for facilitating engagement of the test strip with a testing meter, to permit the testing meter to impart a lifting movement to the test strip.

31. The testing device of claim 1 wherein the test strip holder includes a window for permitting the user to view the test strip to determine whether sufficient body fluid has been applied to the test strip to give a precise and accurate result.

32. The testing device of claim 1 wherein the test strip includes a reaction area and a reagent capable of producing a color upon reaction with the body fluid, whereby the color provides an indication of the test results.

27. The testing device of claim 26 wherein the cleansing member includes an aperture, and the penetrator is disposed adjacent the first end of the body portion and is extendable through the aperture in the cleansing member as it moves from its retracted position to its axially extended position, and the tissue penetrator includes a depth adjuster for permitting the user to adjust the axial distance traveled by the tissue penetrator between its retracted and extended positions.