Method and apparatus for collecting and transporting capillary blood samples for diagnostic and research evaluation

• US 20030195435A1
• Filed: 04/12/2002
• Published: 10/16/2003
• Est. Priority Date: 04/12/2002
• Status: Abandoned Application

• Current Assignee: Arthur G. Williams
• Original Assignee: Arthur G. Williams
• Inventors: Williams, Arthur G.
• Application Number:
  US10/120,483
• Publication Number:
  US 20030195435A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/150893 by indicating if used, tampered with, unsterile or defective
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A method and collection and transport device for collecting biological samples, such as a blood sample, from a subject wherein the method and device include a body having a slide member mounted therein and movable from a first position wherein a collection well of the slide member is aligned to receive a sample from the subject to a second position wherein the sample communicates with a chemical reagent contained within a cavity of the body. The sample well and chemical reagent cavity are sealed from the exterior of the body when the slide member is in the second position. In preferred embodiments, locking means are provided to retain the slide member in the second position. In some embodiments, a lancet mechanism may be provided with the transport and collection device.

Claims

1. A method for collecting and transporting capillary blood and/or biological samples using a collection and transport device having a slide mounted therein and wherein the slide includes a sample receiving well which is movable from a first collecting position for receiving a sample to a second position in which the sample may be subjected to a chemical reagent contained within the device, the method comprising the steps of:

a. obtaining a small capillary blood or biological sample and placing the sample the collection well;

b. moving the collection well from the first position to the second position wherein the collection well is aligned such that the sample contained therein is subjected to the reagent within the device and such that the reagent and the sample are completely sealed within the device;

c. conveying the device to a testing facility;

d. at the testing facility withdrawing the sample subjected to the chemical reagent from the device so that the sample may be analyzed; and

e. thereafter analyzing the sample and reporting the results of the analysis.

2. The method of claim 1 including the additional step of applying a scanable code to the collection and transport device including identifying data with respect to the subject prior to the subject obtaining the sample and placing the sample within the collection well.

3. The method of claim 2 including the additional step of providing an approved biological mailer, placing the device with the sample and chemical reagent within the approved device prior to conveying the mailer to the testing facility.

4. The method of claim 3 including the additional step of providing a tamper indicating seal over the collection well of the device prior to supplying the device to the subject, and removing the tamper indicating seal prior to placing a blood sample within the collection well.

5. The method of claim 1 wherein the sample is capillary blood and the capillary blood and chemical reagent are mixed within the device.

6. An apparatus for collecting and transporting a biological sample such as a capillary blood sample, from a subject such that a sample may be taken in a first location, placed in a device and the device transported to a second location wherein the sample is tested and analyzed, the device including;

a body having a channel formed therein spaced from an upper surface thereof, a first opening in said upper surface communicating with a first portion of said channel, a slide member mounted within said channel and being movable with respect thereto, means for sealing said slide member in fluid tight relationship with respect to said channel, a reagent cavity formed within said body and having a chemical reagent contained therein, means for communicating said cavity with said channel, a collection well formed within said slide member for receiving a sample from a subject when the slide member is in a first position wherein said well is aligned with said first opening in said upper surface of said body, said slide member being movable to a second position wherein said collection well is aligned such that a sample contained therein may communicate with the reagent contained within said cavity, and means for sealing said cavity but allowing a probe insertion into said cavity through said body such that a sample reacted with the chemical reagent may be withdrawn therefrom.

7. The apparatus of claim 6 in which said collection well defines an opening through said slide member and wherein the dimensions defining said opening through said slide member may be varied to effectively control an amount of sample contained within the said collection well.

8. The apparatus of claim 7 in which said slide member includes an operating tab extending outwardly of said body so as to be engageable to urge said slide member from said first to said second position.

9. The apparatus of claim 8 including a second opening in said body, said tab extending through said second opening and said second opening being spaced from said first opening.

10. The apparatus of claim 8 including a lancet means mounted within said body, and means for activating said lancet so as to extend outwardly of said body and thereafter be withdrawn within said body.

11. The apparatus of claim 10 in which said lancet means includes a resilient element for normally urging said lance means within said body.

12. The apparatus of claim 11 in which said lancet means is normally covered by a protective seal extending across a surface of said body.

13. The apparatus of claim 7 in which said first opening in said body includes an inwardly tapering side wall forming a funnel which is aligned with said collection well of said slide member when said slide member is in said first position.

14. The apparatus of claim 7 including indicia means associated with said slide member for indicating said slide member is in said first position and second indicia means associated with said slide member for indicating that said slide member is in said second position.

15. The apparatus of claim 7 including locking means for locking said slide member in said second position when moved to said second position from said first position.

16. The apparatus of claim 15 in which said locking means includes elements for preventing said slide member from being moved from said second position to said first position.

17. The apparatus of claim 7 including scanable code means provided along an outer surface of said body member for providing information with respect to the subject.

18. The apparatus of claim 7 including a bio-protective mailer of a size to receive said transport and collection device therein.