Body fluid sampler

• US 6,614,522 B1
• Filed: 11/27/2000
• Issued: 09/02/2003
• 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:
  US09/723,339
• Time in Patent Office: 1,009 Days
• Field of Search: 356/39, 356/244-246, 600/578, 600/579, 600/584, 128/78, 128/763, 128/770, 128/771
• US Class Current: 356/244
• 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
• 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 5/150022 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 5/150412 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• 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 fluid sampler for collecting fluid from a patient for testing for constituents, the fluid sampler adapted for attachment to a body fluid testing apparatus, the fluid sampler comprising:

a member having a sample portion and a handle portion, the sample portion being positionable relative to the handle portion in a storage position and a sample position;

a medium carried on the sample portion of the sampler; and

a needle comprising a first end projecting from the sampler and a second end in fluid communication with and substantially perpendicular to the medium.

2. The fluid sampler of claim 1 wherein:

the handle portion is formed from a sampler housing defining a cavity; and

the sample portion is pivotally connected to the sampler housing.

3. The fluid sampler of claim 2 wherein the needle is positioned within the cavity of the sampler housing when the sample portion is in the storage position.

4. The fluid sampler of claim 2 further comprising:

a first cam follower coupled to the sample portion and responsive to a cam, the first cam follower being positioned to move the sample portion from the storage position to the sample position as the first cam coupler is displaced by the cam; and

a second cam follower coupled to the sample portion and responsive to the cam, the second cam follower positioned to move the sample portion from the sample position to the storage position as the second cam coupler is displaced by the cam.

5. The fluid sampler of claim 1 wherein the sampler is an elongated member having one end forming the sample portion and an oppositely disposed end forming the handle portion.

6. The fluid sampler of claim 1 wherein the medium is a membrane, the membrane being absorbent to fluid.

7. A fluid sampler for collecting a body fluid from a patient for subsequent testing for constituents, the fluid sampler-comprising:

a member having a handle and a sample end, the sample end being positionable relative to the handle portion in a storage position and a sample position;

a collection apparatus carried on the sampler, and including;

A a needle for penetration of a skin layer of the patient and drawing body fluid from the layer into the sampler;

B a medium carried on the sampler and in fluid flow communication with the needle for the fluid to flow from the needle on to the medium; and

a housing defining a sample location, the sampler being movable into a predetermined position within the housing so that the medium is positioned in a predetermined position relative to the sample location.

8. The fluid sampler of claim 7 wherein:

the handle defines a cavity; and

the sample end is pivotally connected to the sampler housing.

9. The fluid sampler of claim 8 wherein the needle is positioned within the cavity of the handle when the sample end is in the storage position.

10. The fluid sampler of claim 8 further comprising:

a first cam follower coupled to the sample end and positioned to move the sample portion from the storage position to the sample position as the first cam coupler is displaced by the cam; and

a second cam follower coupled to the sample end and positioned to move the sample portion from the sample position to the storage position as the second cam coupler is displaced by the cam.

11. The fluid sampler of claim 7 wherein the sampler is an elongated member having one end forming the sample end and an oppositely disposed end forming the handle.

12. The fluid sampler of claim 7 wherein the medium is a membrane, the membrane being absorbent to fluid.

13. A fluid sampler for a body fluid testing apparatus, the apparatus including a housing having a sample location, electronics having a terminal in electrical communication with the test area, and an opening of predetermined geometry defining an access to the sample location, the fluid sampler comprising:

a member having a handle portion and a sample portion;

the sample portion having a mating geometry with the predetermined geometry for the sample portion to be inserted into the opening in a predetermined alignment with the sample location and

a collection apparatus carried on the sampler portion and including;

A a needle sized to protrude beyond the housing when the sampler is in the predetermined alignment with the needle protruding a distance selected for the needle to penetrate into a fluid laden skin layer when the housing is urged against the skin layer by the operator, and

B a medium carried on the sample portion and in fluid flow communication with the needle for body fluid to flow from the needle onto the medium.

14. The fluid sampler of claim 13 wherein the opening in the housing for the fluid testing apparatus extends along a side of the housing and onto a distal end of the housing, further wherein:

the mating geometry including a needle receiving portion of the body sized to project into the opening with the needle extending through the distal end of the housing.

15. The fluid sampler of claim 13 wherein the housing for the fluid testing apparatus includes a first latch member, further wherein:

the sampler includes a second latch member disposed to releasably engage and latch with the first latch member when the sample portion of the sampler is in the predetermined alignment with the sampling location.

16. The fluid sampler of claim 13 wherein:

the handle portion defines a cavity; and

the sample portion is connected to the handle portion and movable relative thereto between a sample position with the needle disposed exterior of the cavity and a storage position with the needle disposed within the cavity.

18. The fluid sampler of claim 16 wherein the housing of the fluid testing apparatus includes a cam positioned to engage the sampler as the sampler is inserted into the opening, the sampler further comprising:

a first cam follower coupled to the sample end and positioned to engage the cam with the first cam follower urging the sample end to move from the storage position to the sample position as the first cam follower is displaced by the cam.

19. The fluid sampler of claim 18 wherein the sample portion is pivotally secured to the handle portion for pivoting movement of the sample portion relative to the handle portion between the sample position and the storage position.

20. The fluid sampler of claim 18 further comprising:

a second cam follower coupled to the sample portion and positioned to engage the cam as the sampler is removed from the opening with the second cam follower positioned to at least partially urge the sample portion from the sample position to the storage position as the second cam follower is displaced by the cam.

21. The fluid sampler of claim 20 further comprising:

a spring positioned to be deflected in response to partial movement of the sample portion from the sample position with deflected spring urging the sample portion to the storage position and restraining the sample portion in the storage position.

22. The fluid sampler of claim 18 further comprising:

means for restraining the sample portion in the storage position until the cam follower is displaced by the cam.

23. The fluid sampler of claim 16 wherein the medium is positioned on the sample portion for the medium to be disposed within the cavity when the sample portion is in the storage position and to be disposed exterior of the cavity when the sample portion is in the sample position.

17. The fluid sampler 14 wherein the sample portion is pivotally secured to the handle portion for pivoting movement of the sample portion relative to the handle portion between the sample position and the storage position.