Consolidated body fluid testing device and method

• US 6,840,912 B2
• Filed: 12/06/2002
• Issued: 01/11/2005
• Est. Priority Date: 12/07/2001
• Status: Expired due to Fees

• Current Assignee: Hans Kloepfer
• Original Assignee: Micronix, Inc.
• Inventors: Roach, Charles W., Kloepfer, Hans G., Thomeczek, Charles, Hafellner, Reinhard
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US10/313,331
• Publication Number:
  US 20030109777A1
• Time in Patent Office: 767 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 605/181, 605/182
• 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.

Claims

1. A body fluid testing device comprising:

a body member, including a first end, a second end, and a hand engaging surface disposed between the first and second ends,

a tissue penetrator carried by the body member, the tissue penetrator being axially movable between a retracted and an extended position, and including a biasing member for biasing the tissue penetrator into the extended position,

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 tissue penetrator for inducing an enhanced flow of fluid from a penetrated tissue site,

a cleansing member carried by the body member for cleansing a body tissue site to be penetrated by the tissue penetrator,

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,

wherein the cleansing member includes an aperture, and the tissue penetrator is disposed adjacent the first end of the body member and is extendable through the aperture in the cleansing member as the tissue penetrator moves from its retracted position to its axially extended position.

2. The testing device of claim 1 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.

3. The testing device of claim 1 wherein the tissue penetrator includes a depth adjuster for permitting a user to adjust the axial distance traveled by the tissue penetrator between its retracted and extended positions.

4. The testing device of claim 1 wherein the body fluid to be tested comprises mammalian blood.

5. A body fluid testing device comprising:

a body member,

a tissue penetrator carried by the body member,

a cleansing member carried by the body member for cleansing a tissue site to be penetrated by the tissue penetrator,

a test strip holder carried by the body member,

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,

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, 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, the cap member being movable between a closed position wherein the cleansing member and tissue penetrator are covered by the cap member, and an opened position where the cleansing member and tissue penetrator are exposed.

6. A body fluid testing device comprising:

a body member, including a first end, a second end, and a hand engaging surface disposed between the first and second ends,

a tissue penetrator carried by the body member, the tissue penetrator being axially movable between a retracted and an extended position, and including a biasing member for biasing the tissue penetrator into the extended position,

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 tissue penetrator for inducing an enhanced flow of fluid from a penetrated tissue site the pressure inducing member comprising a cap member disposed adjacent the first end of the body member, the cap member being hingedly coupled to the body member,

a cleansing member carried by the body member for cleansing a body tissue site to be penetrated by the tissue penetrator,

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,

wherein the cap member is movable between a closed position wherein the cleansing member is covered by the cap member, and an opened position.

7. The testing device of claim 6 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.

8. A body fluid testing device comprising:

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

a tissue penetrator carried by the body member,

a cleansing member carried by the body member for cleansing a tissue site to be penetrated by the tissue penetrator,

a cleansing member receiver disposed at the first end of the body member for receiving the cleansing 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, wherein the cleansing member is generally toroidal and defines an axially extending aperture through which the tissue penetrator can pass.

9. The testing device of claim 8 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, and a retracted 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 tissue when the cleansing member is cleansing tissue.

11. The testing device of claim 10 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.

12. The testing device of claim 10 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 an open position for exposing the cleansing member.

13. The testing device of claim 12 wherein the cap member includes a living hinge for hingedly coupling the cap member to the first end of the body member.

14. A body fluid testing device comprising:

a body member,

a tissue penetrator carried by the body member, the tissue penetrator including a penetrating tip being axially movable between a retracted and an extended position, and including 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,

a cleansing member carried by the body member and having an axially outer cleansing surface for cleansing a body tissue site to be penetrated by the tissue penetrator, the axially outer cleansing surface of the cleansing member being disposed axially outwardly of the penetrating tip 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,

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,

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