Specimen sample collection device and test system

• US 7,927,548 B2
• Filed: 07/14/2007
• Issued: 04/19/2011
• Est. Priority Date: 01/27/2005
• Status: Expired due to Fees

• Current Assignee: Bamburgh Marrsh LLC (MDM Group, Inc.)
• Original Assignee: Bamburgh Marrsh LLC (MDM Group, Inc.)
• Inventors: Smith, Paul, Herrig, Richard, Giddings, Jason, Seritella, Keith, Slowey, Paul D., Ennis, John, Wickstead, James
• Primary Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US11/827,898
• Publication Number:
  US 20080118397A1
• Time in Patent Office: 1,375 Days
• Field of Search: 422/100, 422/101, 422/102, 600/573, 435/287.7
• US Class Current: 422/422
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising

Abstract

A specimen sample collection device includes a handle having a sufficiency indicator and an absorbent pad partially contained within said handle. A specimen sample collection device and test system includes a handle having a sufficiency indicator, an absorbent pad partially contained within said handle, a pad compression tube insertable over said absorbent pad within said handle and around an end of said handle, and a collection tube having one or more sample chambers, attachable to said pad compression tube, and wherein said compression tube defines one or more chambers, and wherein when said collection tube is attached to said pad compression tube, the chambers are in fluid communication with said pad compression tube. A specimen sample collection device including a sufficiency indicator made up of a light pipe indicator window. A specimen sample collection device including an absorbent pad split and divided into two lengths connected at a base. A specimen sample collection device including a bar code identification. A specimen sample collection device and test system including a lock and key securing mechanism. A specimen sample collection device including a handle one or more analyte test strips A specimen sample collection device and test system including a reader.

Claims

1. A specimen sample collection device and test system, comprising:

a handle having opposing first and second ends, including a sufficiency indicator, and first and second uni-directional locking teeth disposed on opposing sides of said handle;

an absorbent pad partially contained within said handle and extending out from said handle first end;

a pad compression tube insertable over said absorbent pad and around said first end of said handle, said pad compression tube including one or more outlets and a plurality of locking holes on opposing sides of said pad compression tube for lockingly engaging said locking teeth, said locking holes spaced apart lengthwise on said compression tube to lock said pad compression tube over said handle first end in progressively tighter compression positions; and

,

a collection tube sealingly connectable to a pad compression tube outlet, said collection tube including one or more sample chambers, wherein when said collection tube is sealingly connected to a pad compression tube outlet at least one of said corresponding one or more sample chambers is in fluid communication with said pad compression tube and said absorbent pad.

2. The apparatus of claim 1, wherein said indicator is a light pipe, said light pipe including a first end surface with a marking and a second surface in physical contact with said absorbent pad creating a refractive boundary, said second surface oriented at an angle of incidence to said first surface such that when the absorbent pad absorbs a sufficient liquid sample the refractive properties of said boundary alter the observability of the mark;

and,

wherein said apparatus includes a spring compressor within said handle, said spring compressor shaped to conform to the profile of said second surface of said light pipe such that the compression spring forces said absorbent pad into contact with said second surface of said light pipe.

3. The apparatus of claim 1, wherein said indicator comprises a window, a sponge and a loaded spring set into said sponge, wherein said sponge is in fluid communication with the absorbent pad, such that when the sponge is softened by absorption of liquid the spring partially or completely disengages from the sponge and snaps into view of said window, providing visual and audible indication that sample volume is adequate.

4. The apparatus of claim 1, wherein said indicator comprises a clear window and a material which expands when wetted, said material in fluid communication with said absorbent pad, wherein the expandable material will expand to obscure the window when sample volume is adequate.

5. The apparatus of claim 1, wherein said indicator comprises an electrical circuit, said electrical circuit comprising:

a pair of leads composed of galvanically dissimilar conductors connected across said absorbent pad, at a location along the absorbent pad selected to indicate sufficient liquid sample has been absorbed, and

a liquid crystal display connected in series between said pair of leads;

such that, when liquid saturates the absorbent pad up to said location, a galvanic couple is created between said pair of leads, allowing electric current to flow through said liquid crystal display and change the liquid crystal display state, thereby providing visual indication of sample adequacy.

6. The apparatus of claim 1, wherein said indicator comprises a window and a paper with a colored dot located on the inward surface of said paper, wherein said paper becomes translucent when saturated with liquid, and further wherein said paper is located in close proximity to said absorbent pad at a location along the length of said absorbent pad, such that when the absorbent pad becomes saturated with liquid at least to said location the absorbent pad expands to contact the paper, thereby transferring liquid to the paper allowing the paper to become saturated and thereby making the dot visible through said window.

7. The apparatus of claim 1, wherein the indicator is a window coated on the inside with a hydrochromic material such that when absorbent pad swells with sample it absorbs, the wet, swollen pad touches the inside of the window, reacting with the coating and causing a color change or graphic symbol to appear.

8. The apparatus of claim 1, wherein said absorbent pad is rounded in that portion protruding from said handle.

9. The apparatus of claim 1, wherein said absorbent pad is split, divided into two parts and connected at a base of said absorbent pad.

10. The apparatus of claim 9, wherein said pad compression tube defines two chambers into which a corresponding part of said split absorbent pad can be inserted and each of said pad compression tube chambers has includes an outlet.

11. The apparatus of claim 1, wherein said handle is further provided with a bar code number uniquely identifying said handle.

12. The apparatus of claim 1, further comprising:

said handle further includes a test strip viewing window disposed therein;

an analyte test strip contained within said handle in view of said viewing window; and

a membrane contained within said handle, wherein said said absorbent pad is in fluid communication with said test strip through said membrane.

13. The apparatus of claim 12, further comprising two or more analyte test strips contained within said handle in view of said viewing window and two or more corresponding membranes contained within said handle, wherein said absorbent pad is in fluid communication with each of said test strips through said corresponding membranes.

14. The apparatus of claim 12, further comprising two or more analyte test strips contained within said handle in view of said viewing window and a single membrane contained within said handle, wherein said absorbent pad is in fluid communication with each of said test strips through said membrane.

15. The apparatus of claim 1, wherein the absorbent pad is folded over upon itself.

16. A specimen sample collection device and test system, comprising:

a handle having opposing first and second ends, said handle further including a sufficiency indicator, a viewing window for viewing results from a test strip, wherein said sufficiency indicator and test strip are located along opposing sides of said handle;

an analyte test strip contained within said handle;

a first absorbent pad partially contained within said handle and extending out from said first end, said first absorbent pad in fluid communication with said sufficiency indicator but not in fluid communication with said test strip, wherein said first absorbent pad is sized to collect a predetermined volume of liquid specimen;

a second absorbent pad partially contained within said handle and extending out from said first end, wherein said second absorbent pad is in fluid communication with said test strip but not in fluid communication with said sufficiency indicator and wherein said second absorbent pad is parallel to said first absorbent pad;

a pad compression tube insertable over said first and second absorbent pads and around said first end of said handle, said pad compression tube including one or more outlets; and

,

a collection tube having one or more sample chambers, wherein each of said one or more collection tube chambers is sealingly connectable to one of said one or more pad compression tube outlets in fluid communication with said pad compression tube and said first and second absorbent pads.

17. The apparatus of claim 16 further comprising an impermeable membrane separating said first and second absorbent pads.

18. The apparatus of claim 16 or 17, wherein said handle includes a pair of uni-directional locking teeth on opposing sides of said handle and wherein said pad compression tube includes a plurality of locking holes on opposing sides of said pad compression tube for lockingly engaging said locking teeth, said locking holes spaced apart lengthwise on said compression tube to lock said pad compression tube over said handle in progressively tighter compression positions.