Self-contained test unit for testing body fluids

• US 7,846,110 B2
• Filed: 08/01/2007
• Issued: 12/07/2010
• Est. Priority Date: 08/03/2006
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Advanced Medical Products GmbH
• Inventors: Hafellner, Reinhard, Kloepfer, Thomas, Kloepfer, Hans G.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/832,475
• Publication Number:
  US 20080033319A1
• Time in Patent Office: 1,224 Days
• Field of Search: 600/573, 600583-584, 606/181, 606/182, 606/184, 606/185
• US Class Current: 600/584
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150526 Curved or bent needles
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A self contained disposable test unit for testing body fluid comprises a body member and a support member. The support member is moveable with respect to the body member between a first position and a second position. The support member includes a body part receiving surface for receiving a patient'"'"'s body part. A lancet is carried by the body member and includes a lancet tip capable of piercing the skin of a patient to produce fluid flow. A test member is capable of interacting with body fluid to aid in the determination of information about body fluid components. A capillary member is capable of directing fluid flow to the test member. A pressure cup is capable of exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary, and a calibration member is provided for containing information for facilitating calibration of the test unit.

Claims

1. A self contained disposable testing unit for testing body fluid comprising:

a body member,

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet movable with respect to the support member, the lancet including a first end portion pivotably coupled to the body member for pivotal movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

a pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary; and

a calibration member capable of containing information for facilitating calibration of the testing unit.

2. The testing unit of claim 1 wherein the lancet is pivotably moveable between

(1) a storage position wherein the lancet tip is disposed below the body part receiving surface of the support member,

(2) a piercing position wherein the lancet tip is disposed above the body part receiving surface of the support member, and

(3) a retracted position wherein the lancet tip is disposed below the body part receiving surface of the support member,

wherein the lancet is moved into the retracted position through an engagement of the support member with the lancet as the support member moves between the first and the second position.

3. The testing unit of claim 2 wherein the lancet moves generally perpendicularly to a patient'"'"'s skin when the lancet pierces a patient'"'"'s skin as the lancet moves between the storage position and the piercing position, and wherein the lancet assumes the piercing position when the support member is positioned between the first position and the second position.

4. The testing unit of claim 2 wherein the body member includes a lancet movement resisting surface for providing resistance to movement of the lancet into the retracted position.

5. The testing unit of claim 2 wherein the lancet includes a first end pivotably coupled to the body member to permit the lancet tip to move in an arcuate path between the piercing position and the retracted position.

6. The testing unit of claim 2 wherein the body member and the support member share a common axis and wherein the support and body members are rotatable relative to each other about the common axis for permitting the user to vary a distance into which the lancet can penetrate the skin when in the piercing position.

7. The testing unit of claim 6 wherein the support member includes at least a first and a second surface that are axially offset and selectively engagable with the lancet for moving the lancet to the retracted position, the first and second surfaces being circumferentially offset so that rotational movement of the support member causes a different one of the at least first and second surfaces to engage the lancet.

8. The testing unit of claim 2 wherein the support member includes at least a first and a second surface that are selectively engagable with the lancet for moving the lancet to the retracted position, wherein the first and second selectively engagable surfaces are axially offset, such that when the first surface engages the lancet, a depth to which the tip will penetrate a patient'"'"'s skin is different than a depth to which the tip will penetrate a patient'"'"'s skin when the second surface engages the lancet.

9. The testing unit of claim 2 further comprising a retraction spring for moving the lancet from the piercing position to the retracted position.

10. The testing unit of claim 2 wherein the lancet is pivotably movable between the piercing position and the retracted position.

11. The testing unit of claim 1 wherein at least one of the capillary member and test member include a reaction capillary compartment and an excess blood capillary compartment, and wherein blood components are separated by the test unit by a capillary force differential between the reaction capillary compartment and the excess blood capillary compartment.

12. The testing unit of claim 11 wherein the capillary force differential is caused by height difference between the reaction blood capillary compartment and the excess blood capillary compartment.

13. The testing unit of claim 12 wherein said height differential is generated by a bending of the reagent containing test member wherein bending is activated by at least one of a user pressing against the support member or bending is activated by a user releasing pressure against the support member.

14. The testing unit of claim 1 wherein the support member includes the capillary member, and the testing member comprises a reagent containing test member disposed downstream of the capillary member.

15. The testing unit of claim 1 further comprising a lancet position adjustor for permitting a user to vary a distance into which the lancet can penetrate a patient'"'"'s skin when in the piercing position and a cap member hingedly coupled to the support member and moveable between a closed position where the cap member overlays and covers the support member, and an open position wherein the support member is uncovered and capable of receiving a body part.

16. The testing unit of claim 1 where the lancet includes a radially extending portion that extends radially between the first and second end portions so that the first and second end portions extend in a parallel, non-collinear relation.

17. The testing unit of claim 1 wherein the support member includes a capillary portion for separating body fluid components from whole body fluid in fluid communication with the body part receiving surface, and a reagent containing test member disposed downstream of the capillary portion.

18. The testing unit of claim 1 wherein the lancet can move into a piercing position wherein the lancet tip is disposed above the body part receiving surface further comprising a lancet position adjustor for permitting a user to vary a distance above the body part receiving surface that the lancet can extend.

19. The testing unit of claim 1 wherein the test member is capable of being read by a digital camera, and includes a mounting member for mounting the test member to a digital camera.

20. The testing unit of claim 1 wherein the calibration member is capable of being read by a digital camera.

21. The testing unit of claim 1 further comprising a cleansing member integrated into the testing unit.

22. The testing device of claim 1 wherein the first end portion extends generally chordally and the second end portion extends generally axially, whereby pivotal movement of the first end portion relative to the body member causes the tip of the second end portion to move in an arc generally perpendicular to the body receiving surface.

23. A self contained disposable testing unit for testing body fluid comprising:

a body member

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and a the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

the lancet being pivotably moveable between

(1) a storage position wherein the tip is disposed below the body part receiving surface of the support member,

(2) a piercing position wherein the tip is disposed above the body part receiving surface of the support member, and

(3) a retracted position wherein the tip is disposed below the body part receiving surface of the support member,

wherein the lancet is moved into the retracted position through an engagement of the support member with the lancet as the support member moves between the first and the second position

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

a pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary;

a calibration member capable of containing information for facilitating calibration of the testing unit; and

a lancet position adjustor for permitting a user to vary a distance into which the lancet can penetrate a patient'"'"'s skin when in the piercing position, and wherein the lancet strikes a skin surface generally perpendicularly to the skin surface.

24. The testing unit of claim 23 wherein when the lancet is in the storage position, the lancet is carried by the body portion in a fixed position, and the support member includes at least a first and a second surface that are selectively engagable with the lancet for moving the lancet to the retracted position.

25. The testing unit of claim 24 wherein the first and second selectively engageable surfaces are axially offset, such that when the first surface engages the lancet, a depth to which the tip will penetrate a patient'"'"'s skin is different than a depth to which the tip will penetrate a patient'"'"'s skin when the second surface engages the lancet.

26. The testing unit of claim 24 wherein the lancet includes a radially extending portion extending between the first end portion and the second end portion, and the second end portion extends parallel with but not collinear with the first end portion.

27. The testing unit of claim 26 wherein the first end portion of the lancet is pivotably coupled to the body member, to permit the lancet to pivotally move in an arc between the piercing position and the retracted position.

28. The testing unit of claim 27 wherein the body member includes a lancet movement resisting surface for providing resistance to movement of the lancet into the retracted position without preventing the movement of the lancet into the retracted position.

29. The testing device of claim 26 wherein the radially extending portion extends generally perpendicularly to the first end portion, and the second end portion extends generally perpendicularly to the each of the first end portion and radially extending portion.

30. The testing unit of claim 26 wherein the radially extending portion extends generally perpendicularly to each of the first end portion and the second end portion, and the second end portion extends generally perpendicularly to each of the first end portion and radially extending portion.

31. A testing system for testing body fluid comprising a digital camera containing device having a case, and a self contained disposable testing unit for testing body fluid, the self-contained testing unit comprising:

a body member,

a support member moveable with respect to the body member between a first position and

a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet carried by the body member and including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member, and

a calibration member capable of containing information for facilitating calibration of the testing unit further comprising a coupler for coupling the testing unit to the case of the digital camera containing device capable of reading a test result on the reagent containing test member.

32. The testing unit of claim 31 wherein the body member includes a base that includes the coupler and an aperture for permitting a direct line of sight between the camera and the reagent containing test member, and wherein the coupler comprises at least one of a bayonet mount type coupler and a screw mount type coupler.

33. The testing device of claim 31 wherein the lancet includes a first end portion coupled to the body member, and a second end portion includes a piercing tip disposed generally perpendicularly to the first end portion.

34. The testing device of claim 31 wherein the lancet is pivotably coupled to the body member for pivoting movement with respect to the body member, wherein the support member is movable with respect to the lancet and engagable with the lancet to cause pivotal movement of the lancet.

35. A self contained disposable testing unit for testing body fluid comprising:

a body member

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary; and

a calibration member capable of containing information for facilitating calibration of the testing unit

wherein the support member is movable with respect to the lancet and engagable with the lancet to cause pivotal movement of the lancet tip in an arcuate path.

36. A self contained disposable testing unit for testing body fluid comprising:

a body member,

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

a pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary; and

a calibration member capable of containing information for facilitating calibration of the testing unit

further comprising a skin distance member disposed interiorly of the pressure cup for maintaining a patient'"'"'s body part at an appropriate position wherein a patient'"'"'s body part will not engage an inlet to the capillary member.

37. A self contained disposable testing unit for testing body fluid comprising:

a body member,

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

a pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary; and

a calibration member capable of containing information for facilitating calibration of the testing unit

wherein the support member is movable with respect to the lancet and engagable with the lancet to cause pivotal movement of the lancet toward the retracted position.

38. A self contained disposable testing unit for testing body fluid comprising:

a body member

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip; and

wherein the lancet includes a radially extending portion extending between the first and the second end portions, wherein the support member is movable with respect to the lancet and engagable with the lancet to cause pivotal movement of the lancet

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member,

a pressure cup for exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary; and

a calibration member capable of containing information for facilitating calibration of the testing unit.

39. A self contained disposable testing unit for testing body fluid comprising:

a body member

a support member moveable with respect to the body member between a first position and a second position, the support member including a body part receiving surface for receiving a patient'"'"'s body part,

a lancet movable with respect to the support member, the lancet including a first end portion pivotably coupled to the body member for pivoting movement with respect to the body member, and a second end portion having a second end and a base end, the base end being disposed closer to the first end portion than the second end and the second end including a lancet tip capable of piercing a patient'"'"'s skin to produce fluid flow, wherein during pivotal movement of the lancet, the base end and lancet tip of the second end portion move in an arcuate path and extend along a tangent of an arc scribed by the pivotal movement, wherein the base end follows the lancet tip;

a test member capable of interacting with body fluid to aid in determining information about body fluid components;

a capillary member capable of directing fluid flow to the test member.

40. The testing unit of claim 39 wherein the lancet includes a radially extending portion extending between the first end portion and the second end portion, and the second end portion extends parallel with but not collinear with the first end portion.

41. The testing device of claim 40 wherein the radially extending portion extends generally perpendicularly to the first end portion, and the second end portion extends generally perpendicularly to the each of the first end portion and radially extending portion.