Disposable fluid sample collection device

• US 8,158,062 B2
• Filed: 11/05/2004
• Issued: 04/17/2012
• Est. Priority Date: 11/05/2003
• Status: Active Grant

• Current Assignee: Ben Lane, Brian Bean, Brian Lipford, Brian P. Murphy, Chris Dykes, Eva Dixon, Mike Abbott, Samuel Reed
• Original Assignee: Ben Lane, Brian Bean, Brian Lipford, Brian P. Murphy, Chris Dykes, Eva Dixon, Mike Abbott, Samuel Reed
• Inventors: Dykes, Chris, Lane, Ben, Murphy, Brian, Dixon, Eva, Bean, Brian, Lipford, Brian, Reed, Samuel, Abbott, Mike
• Primary Examiner(s): Bullock, In Suk
• Assistant Examiner(s): Pregler, Sharon
• Application Number:
  US10/578,453
• Publication Number:
  US 20080025872A1
• Time in Patent Office: 2,720 Days
• Field of Search: 422/50, 422/400, 422/401, 422/402, 422/403, 422/412, 422/60, 422/61, 422/62, 422/63, 422/64, 422/65, 422/66, 422/67, 422/502, 422/55, 422/4, 422/430, 422/68.1, 204/403, 204/409, 324/438, 324/439
• US Class Current: 422/68.1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043

Abstract

A fluid sampling device (100) that operates by a combination of capillary action to collect a small fluid sample, and by pressure differential when inserted into an analyzer (200) to expose the fluid sample for testing by the analyzer (200). The device is especially suited for use as a disposable blood sampling unit designed to interface with a blood analyzer, albeit the concept of the invention may be employed for sampling and testing virtually any fluids.

Claims

1. A fluid sample collection device for collecting 0.05 mL or less of blood, and for insertion and testing of said blood in an ultrasonic analyzer, comprising:

a thin elongate body having a finger-grip at one end, and another functional insertion end, said insertion end including,

a collecting region including an entrance aperture through which fluid enters a capillary tube within said collecting region by capillary action;

a testing region in fluid communication with said collecting region for containing at least a portion of said fluid during testing inside said ultrasonic analyzer, said testing region further comprising an open-ended cylindrical channel perpendicular to said capillary tube and passing through said thin elongate body from one external surface to another external surface, thereby defining a circular aperture into said thin elongate body adapted for sealed engagement by an external sensor in said ultrasonic analyzer, said open-ended cylindrical channel containing said portion of said fluid such that said fluid portion comes in direct contact with said external sensor while still sealed inside the testing region, and

a pumping region in fluid communication with said testing region for introducing a pressure-differential and thereby inducting said portion of said fluid from said collecting region into said open-ended channel of said testing region wherein said portion is placed in direct contact at each open end of said channel with a sensing surface of said ultrasonic analyzer.

2. The fluid sample collection device according to claim 1, wherein said pumping region comprises a bulb for introducing said pressure-differential.

3. The fluid sample collection device according to claim 1, wherein said pumping region comprises an orifice for coupling a pump in said ultrasonic analyzer to said testing region for introducing said pressure-differential.

4. The fluid sample collection device according to claim 2, wherein said bulb is operated by insertion of said collection device into said ultrasonic analyzer and squeezing thereof during insertion.

5. The fluid sample collection device according to claim 2, wherein said bulb is operated by squeezing via an actuator in said ultrasonic analyzer.

6. A disposable blood sample collection device for insertion and testing of a blood sample in a portable ultrasonic analyzer, comprising:

an elongate body including,

a collecting region including an entrance aperture through which said blood sample is drawn by capillary action into a capillary tube within said collecting region,

a testing region in fluid communication with said collecting region for containing at least a portion of said blood sample, said testing region further comprising an open-ended cylindrical channel perpendicular to said capillary tube passing through said elongate body from one external surface to another external surface, thereby defining a circular aperture in said thin elongate body adapted to be sealed off between external sensor walls of said portable ultrasonic analyzer when inserted therein such that said portion of said blood sample within said open-ended cylindrical channel is sealed within said open-ended channel and directly exposed to the external sensor walls of said ultrasonic analyzer, and

an orifice in fluid communication with said testing region for coupling a pump inside said ultrasonic analyzer to induct said portion of said blood sample from said collecting region into the open ended channel of said testing region.

7. A disposable blood sample collection device for insertion and testing of a blood sample in a portable ultrasonic analyzer, comprising:

an elongate body including,

a collecting region including an entrance aperture through which a sample of blood is drawn by capillary action into a capillary tube within said collection region,

a testing region in fluid communication with said collecting region for exposing at least a portion of said blood sample to a sensor during testing inside said ultrasonic analyzer, said testing region further comprising an open-ended cylindrical channel perpendicular to said capillary tube and passing through said thin elongate body from one external surface thereof to another, thereby defining a circular aperture in said thin elongate body adapted to be sealed off by an external sensor of said portable ultrasonic analyzer when inserted therein such that the portion of said blood sample is sealed within the cylindrical channel and is directly exposed to said external sensor, and

a bulb in fluid communication with said testing region and manipulated by said analyzer to induct said portion of said blood sample from said collecting region into said open-ended channel of said testing region for testing wherein said blood is placed in direct contact at each open end of the channel with a sensing surface of said ultrasonic analyzer instrument.

8. The disposable blood sample collection device according to claim 7, wherein said bulb is manipulated by said ultrasonic analyzer as a result of insertion therein.

9. The disposable blood sample collection device according to claim 7, wherein said bulb is manipulated by an actuator inside said ultrasonic analyzer.

10. The disposable blood sample collection device according to claim 9, wherein said actuator comprises a solenoid.

11. A disposable blood sample collection device for insertion into an ultrasonic analyzer, comprising:

a thin elongate body adapted for insertion into said ultrasonic analyzer;

a capillary tube integrally-molded in said body and extending inwardly from a distal end;

an open-sided testing region in fluid communication with said capillary tube, said testing region comprising an open-ended cylindrical channel passing through said thin elongate body perpendicular to said capillary tube from one external surface of said body to another, thereby defining a circular aperture in said thin elongate body adapted to be sealed off by an external sensor of said portable ultrasonic analyzer when inserted therein such that at least a portion of a blood sample is sealed within the cylindrical channel and therein directly exposed to said external sensor; and

an actuator region in fluid communication with said testing region for introducing a pressure-differential and thereby inducting said portion of said blood sample from said capillary tube into said open-ended channel of said testing region wherein said portion is placed in direct contact with said sensing walls within said ultrasonic analyzer.

12. The disposable blood sample collection device according to claim 11, wherein said capillary tube is pre-loaded with anticoagulant.

13. The disposable blood sample collection device according to claim 11, wherein said thin elongate body comprises at least one edge which communicates with said ultrasonic analyzer to correctly position said disposable blood sample collection device with respect to said analyzer.