Consolidated body fluid testing device and method

• US 7,901,364 B2
• Filed: 01/05/2005
• Issued: 03/08/2011
• Est. Priority Date: 12/07/2001
• Status: Expired due to Fees

• Current Assignee: Hans G. Kloepfer
• Original Assignee: Micronix, Inc.
• Inventors: Roach, Charles W., Kloepfer, Hans G., Thomeczek, Charles, Hafellner, Reinhard
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/030,441
• Publication Number:
  US 20050177072A1
• Time in Patent Office: 2,253 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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. The body member, tissue penetrator, test strip holder and test strip are designed for a single use and for disposal as a unit without disassembly.

Claims

1. A single use, disposable body fluid testing device for use with a testing meter, the device comprising:

a disposable body member, the body member being a separate component from the testing meter,

an axially moveable tissue penetrator carried by the body member, the tissue penetrator including a depth adjustor for enabling a user to adjust the extent of axial movement of the tissue penetrator

a test strip holder carried by the body member, and

a test strip carried on the disposable body member 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,

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, wherein the test strip, while being carried on the disposable body member, is lifted relative to the test strip holder by the meter when the test strip is engaged with a testing meter, and

wherein the body member and each of the tissue penetrator, test strip holder and test strip carried on the body member are designed for a single use and for disposal as a unit without disassembly from each other or from other components.

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, and wherein at least one of the test strip receiver and test strip retainer are 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 the lifting movement to the test strip, and the testing meter comprises at least one of a photometric and electro-sensimetric detector.

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 tissue site.

4. The testing device of claim 3 wherein the test strip holder includes a pair of complimentary ramping surfaces formed on the holder for facilitating engagement of the test strip component with the testing meter for permitting the testing meter to lift the test strip as it is inserted into the meter.

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 the tissue penetrator includes an actuator for retaining the tissue penetrator in the retracted position, and upon activation by a user, for releasing the tissue penetrator to permit the tissue penetrator 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 penetrator wherein the cleansing member is disposed adjacent to the first end of the body member, and includes a cleanser containing pad for cleaning the tissue area to be penetrated by the tissue penetrator.

9. 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 a user, to move into the extended position.

10. The testing device of claim 9, 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.

11. The testing device of claim 1 further comprising a single use disposable cleansing member carried by the body member and disposed adjacent to the tissue penetrator for cleansing a tissue site immediately prior to the site being penetrated by the tissue penetrator, the cleansing member being coupled to the body member for disposal with the body member as a unit.

12. 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.

13. 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.

19. The testing device of claim 4 wherein the depth gauge includes a pointer that is reconcilable with a gauging surface to provide an indication to the user of the relative depth to which the tissue penetrator will penetrate.

20. The testing device of claim 19 wherein the depth adjuster includes a camming surface for facilitating axial movement, and wherein the gauge include a gauging wheel rotatable by a user to vary the depth to which the tissue penetrator will extend.

14. A single use, disposable body fluid testing device comprising:

a disposable body member having a first end and a second end,

an axially moveable tissue penetrator carried by the body member adjacent to the first end of the body member, the tissue penetrator including a depth adjuster for enabling a user to adjust the extent of axial movement of the tissue penetrator,

a test strip holder carried by the body member adjacent to the second end of the body member,

a test strip carried on the disposable body member by the test strip holder adjacent to the second end of the body member, 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, and

a single use disposable cleansing member carried by the body member, the cleansing member being coupled to the body member for disposal with the body member as a unit and

wherein the test strip holder includes a pair of complimentary ramping surfaces formed on the holder, the ramping surfaces being engageable with a testing meter so that while the test strip is carried by the test strip holder, the testing meter lifts the test strip relative to the test strip holder as the testing meter is inserted into the meter for better fitting of the test strip by the testing meter.

15. The testing device of claim 14 further comprising a pressure inducing member carried by the body member adjacent to the first end of 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 tissue site, further comprising a depth gauge coupled to the depth adjuster, the depth gauge including a pointer, that is reconcilable with a gauging surface to provide an indication of relative depth to which the tissue penetrator will penetrate.

16. A single use, disposable body fluid testing device comprising:

a body member having a first end and a second end;

an axially moveable tissue penetrator carried by the body member adjacent to the first end of the body member, the tissue penetrator including a depth adjustor for enabling a user to adjust the extent of axial movement of the tissue penetrator,

a test strip holder carried by the body member,

a test strip carried by the test strip holder adjacent to the second end of the body member, 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, wherein the test strip holder includes a window adjacent to the test strip 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,

wherein the test strip holder includes a test strip receiver for receiving the test strip, the test strip, while being carried by the test strip holder, is lifted by the testing meter relative to the test strip holder when the test strip is engaged with a testing meter.

21. The testing device of claim 16 further comprising a test strip retainer for retaining the test strip on the test strip receiver, and wherein at least one of the test strip receiver and test strip retainer are positioned in a spaced relation from the test strip for facilitating engagement of the test strip with a testing meter, so that the testing meter engages the test strip to lift the test strip during the time that the test strip enters the testing meter.

17. A body fluid testing device for use with a testing meter, the device comprising:

a single use disposable body member, the body member not being formed as a part of or coupled to the meter, the body member having a first end and a second end,

an axially moveable tissue penetrator carried by the body member, the tissue penetrator including a depth adjustor for enabling a user to adjust the extent of axial movement of the tissue penetrator,

a test strip holder carried on the body member,

a test strip carried on the disposable body member 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, and

a cleansing member carried by the body member, wherein the test strip holder includes a test strip receiver for receiving the test strip, a test strip retainer for retaining the test strip on the test strip receiver, and a hinge for hingedly coupling the test strip receiver to the test strip retainer, and wherein at least one of the test strip receiver and test strip retainer are positioned in a spaced relation from the test strip for facilitating engagement of the test strip with a testing meter, wherein the test strip, while being carried on the disposable body member, is lifted relative to the test strip holder when the test strip is engaged with a testing meter.

18. The testing device of claim 17 further comprising a pressure inducing member carried by the body member adjacent to the first end of 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 tissue site.