Methods of sampling body fluid

• US 6,624,882 B2
• Filed: 08/30/2002
• Issued: 09/23/2003
• Est. Priority Date: 09/08/1995
• Status: Expired due to Term

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Sopp, John P., Erskine, Timothy J., Latterell, Scott T., Brinda, Paul D.
• Primary Examiner(s): STAFIRA, MICHAEL PATRICK
• Application Number:
  US10/233,046
• Publication Number:
  US 20020196425A1
• Time in Patent Office: 389 Days
• Field of Search: 356/39, 356/249, 600/578, 600/579, 600/584, 128/760, 128/763, 128/770, 128/771
• US Class Current: 356/39
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/150358 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/15117 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A sampling apparatus for sampling body fluid includes a sampler having an external geometry selected to mate with an internal geometry of a testing apparatus such that the sampler may be inserted within the testing apparatus in a predetermined alignment-and with a sampling location positioned accurately within a light path for detecting an amount of a desired constituent within fluid collected by the sampler.

Claims

1. A method for collecting a body fluid from a patient for testing for constituents, the method comprising:

providing a sampler attached to a testing apparatus, wherein the sampler comprises a medium and a needle in fluid communication with the medium, the testing apparatus comprises electronics for testing fluid deposited on the medium, and wherein the sampler is movable relative to the testing apparatus between a sample position in which the needle is positioned for insertion into skin and a storage position in which the needle is unable to be inserted into skin;

inserting the needle into the skin on a patient;

passing interstitial fluid from the patient'"'"'s skin to the medium; and

testing the fluid for constituents using the electronics.

2. The method of claim 1 wherein the electronics include a light source and a light detector and wherein the testing the fluid for constituents comprises:

passing a light from the light source to the medium.

3. The method of claim 1 wherein the providing a sampler comprises providing the sampler in the storage position, the method further comprising:

moving the sampler from the storage position to the sample position prior to inserting the needle into the skin.

4. The method of claim 3 further comprising:

moving the sampler from the sample position to the storage position after testing the fluid.

5. The method of claim 1 further comprising:

attaching the sampler to the testing apparatus.

6. The method of claim 5, wherein the testing apparatus defines a cavity and a sample location and wherein the attaching the sampler comprises:

inserting the sampler into the cavity of the testing apparatus;

positioning the medium at a predetermined position relative to the sample location; and

securing the sampler to the test apparatus.

7. The method of claims 3 or 4 wherein the moving steps comprise pivotal movement of the sampler.

8. The method of claims 3 or 4 wherein the moving steps comprise axial movement of the sampler.

9. The method of claim 8 wherein the axial movement of the sampler comprises the use of at last one spring mechanism.

10. A method for collecting a body fluid from a patient for testing for constituents, the method comprising:

providing a sampler comprising a needle in fluid communication with a medium, wherein the sampler is pivotally attached to a housing;

attaching the housing to a testing apparatus for testing fluid deposited on the medium, wherein the sampler is pivotally movable with respect to the testing apparatus between a sample position in which the needle is positioned for insertion into skin and a storage position in which the sampler is substantially enclosed within the housing;

inserting the needle into the skin on a patient;

passing interstitial fluid from the patient'"'"'s skin to the medium; and

testing the fluid for constituents.

11. The method of claim 10 further comprising:

moving the sampler from the storage position to the sample position prior to inserting the needle; and

moving the sampler from the sample position to the storage position after testing the fluid.

12. The method of claim 11 wherein the testing apparatus comprises a light source and a light detector and wherein the moving the sampler from the storage position to the sample position comprises:

positioning the membrane between the light source and the detector.

13. The method of claim 12 wherein the testing the fluid for constituents comprises:

passing a light from the light source to the medium.

14. The method of claim 11 wherein the moving steps comprise pivotal movement of the sampler.

15. The method of claim 11 wherein the moving steps comprise axial movement of the sampler.

16. The method of claim 15 wherein the axial movement of the sampler comprises the use of at least one spring mechanism.

17. The method of claim 13 further comprising:

automatically pivoting the sampler from the storage position to the sample position while attaching the sampler to the testing apparatus.

18. The method of claim 13 further comprising:

automatically pivoting the sampler from the sample position to the storage position while detaching the sampler from the testing apparatus.