CA2027674A1 - Pre-sealed and self-sealing container for the collection and preservation of fluid biological evidence - Google Patents
Pre-sealed and self-sealing container for the collection and preservation of fluid biological evidenceInfo
- Publication number
- CA2027674A1 CA2027674A1 CA 2027674 CA2027674A CA2027674A1 CA 2027674 A1 CA2027674 A1 CA 2027674A1 CA 2027674 CA2027674 CA 2027674 CA 2027674 A CA2027674 A CA 2027674A CA 2027674 A1 CA2027674 A1 CA 2027674A1
- Authority
- CA
- Canada
- Prior art keywords
- vial
- lid
- container assembly
- disk
- rim
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 238000007789 sealing Methods 0.000 title claims abstract description 61
- 239000012530 fluid Substances 0.000 title claims abstract description 23
- 238000004321 preservation Methods 0.000 title abstract description 3
- 239000000853 adhesive Substances 0.000 claims abstract description 32
- 230000001070 adhesive effect Effects 0.000 claims abstract description 32
- 230000002093 peripheral effect Effects 0.000 claims description 19
- 239000013060 biological fluid Substances 0.000 claims description 7
- 239000004973 liquid crystal related substance Substances 0.000 claims description 6
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 claims description 6
- 235000013024 sodium fluoride Nutrition 0.000 claims description 3
- 239000011775 sodium fluoride Substances 0.000 claims description 3
- 230000000007 visual effect Effects 0.000 claims 3
- 238000011179 visual inspection Methods 0.000 claims 3
- 238000011109 contamination Methods 0.000 claims 2
- 238000012360 testing method Methods 0.000 description 21
- 239000000523 sample Substances 0.000 description 13
- 238000000034 method Methods 0.000 description 11
- 239000006260 foam Substances 0.000 description 6
- 238000012863 analytical testing Methods 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 238000003255 drug test Methods 0.000 description 4
- 239000012472 biological sample Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 210000002700 urine Anatomy 0.000 description 3
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000000356 contaminant Substances 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 238000012956 testing procedure Methods 0.000 description 2
- 239000004793 Polystyrene Substances 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 239000013043 chemical agent Substances 0.000 description 1
- 238000013098 chemical test method Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Landscapes
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Richard E. Jensen, Donald H. Nichols, and D. Gary Hemphill PRE-SEALED AND SELF-SEALING CONTAINER FOR THE COLLECTION
AND PRESERVATION OF FLUID BIOLOGICAL EVIDENCE
ABSTRACT OF THE DISCLOSURE
An pre-sealed and self-sealing collection container for collecting and preserving fluid biological evidence comprising a specimen vial and lid, the lid having an adhesive coated disk inserted therein with the lid initially being inverted on the rim of the specimen vial. The specimen vial, lid, and an adhesive backed sealing tape are initially enclosed in a tamper evident wrapper.
AND PRESERVATION OF FLUID BIOLOGICAL EVIDENCE
ABSTRACT OF THE DISCLOSURE
An pre-sealed and self-sealing collection container for collecting and preserving fluid biological evidence comprising a specimen vial and lid, the lid having an adhesive coated disk inserted therein with the lid initially being inverted on the rim of the specimen vial. The specimen vial, lid, and an adhesive backed sealing tape are initially enclosed in a tamper evident wrapper.
Description
2~2767~
PRE-SEALED AND SELF-SEALING CONTAINER FO~ THE COLLECTION
AND PRESERVATION OF FLU D BIOLOGICAL EVIDENCE
BACKGROUND OF THE INVENTION
This invention relates generally to a container for collecting, transporting, and preserving specimens of biological fluid for use as evidence, and particularly for collecting urine specimens and supplying those specimens to a remote laboratory facility for analytical testing.
As described in the above referenced co-pending application, the results of the most careful analytical drug or chemical testing may be affected by contaminants in the sampling or testing containers, including prescription and non-prescription medications or reactive chemical compounds, and the testing procedures themselves may often be attacked on a chain of custody theory in much the same manner as criminal evidence.
,, .
2~2~67~
There is a vested interest on the part of employers and law enforcement agencies who perform routine drug testing to ensure the accuracy and reliability of those tests, and to similarly guarantee that the testing equipment will not be tampered with or questioned. The public, particularly individuals who submit to drug testing as a prerequisite to employment and who are not drug users or abusers, similarly have an interest in accurate testing and in ensuring that the testing methods prevent intentional tampering or minimize human error wherever possible.
While the currently employed methods vary depending upon the testing authority and the equipment provided, there are several common drawbacks to each method which have been identified.
Primarily, while the samples may sometimes be sealed in specimen containers once they have been obtained from the individual being tested, it cannot be verified that the containers being used for the testing were not tampered with, or were free of contaminants, prior to the testing. Similarly, the chaln of custody prior to testing cannot be verified.
, $
2~2~7~
The testing equipment usually provides an ineffective seal for the specimen container, and only one seal when such is provided. The seal may frequently be neglected or omitted by the person supervising the testing. The person being tested often does not have an opportunity to inspect the testing equipment, an important factor to consider for purposes of belaying the apprehensions of the person being testing, or as a means of additional verification of the testing procedures. While a supervising person may be instructed in the proper testing and control procedures, there is always a chance of human error or the possibility that the supervisors will not understand the legal significance lS of the various steps of the process, and so the steps should be made as uniform, repeatable, and as automatic as possible.
Tamper evident seals for plastic containers, such as those u~ed in food packaging, are well known, a representative example being given by United States Patent No. 4,087,018. Additional devices for securing a fluid container and evidencing tampering are known, such as those sealing closures disclosed in United States Patent Nos. 1,996,682 and 4,262,814 and the .
2~27~7~
related art. Another sealed container disposed within a second sealed package is disclosed in United States Patent No. 985,850.
Each of these patents, while being representative of a broad field of art and disclosing a method of identifying or evidencing whether a aontainer has been tampered with, each prove to have one or more defects making them unsuitable for application to the process of collecting a fluid biological sample for use as lo evidence.
Those containers in which an item or product is sealed so as to evidence tampering already contain the item to be protected. There is no provision for the container to exist in a tamper evidencing state prior to the product being placed therein, or for resealing the tamper evidencing closure once the item has been placed in the container. Similarly, there is no apparatus which automatically creates a new tamper evident seal when the container is closed once the original seal is broken, nor that enhances or facilitates verifying the chain of custody of the container.
United States Patent No. 4,362,698 discloses a -permanently sealed laboratory vessel used in blood - 2027~7~
....
testing, however the manner of providing the closure to this vessel is unsuitable for use in the collection of biological samples in the field, or for preserving those samples during transportation to the testing facility.
BRIEF SUMMARY OF THE INVENTION
It is therefore one object of this invention to design a collection container for fluid biological samples which may be used to transport those samples to a remote laboratory facility for analytical testing, and which eliminates many of the defects in the chain of custody associated with existing procedures, particularly the control of the sample container prior to the actual aollection process.
It is another object of this invention to design the above apparatus such that it is highly tamper resistant along the entire chain of supply to the colle¢tion site, and transport to the testing ~0 facility.
It is a further object of this invention to design the above apparatus such that it promotes uniformity in testing, and encourages those supervising the drug testing to take the reasonable and necessary ~027~7~
precautions to ensure the accuracy and reliability of such tests.
It is a still another object of this invention to design the above apparatus such that it includes uniform, repeated, and automatic procedures for preserving the collection sample in a tamper resistant container.
Briefly described, the collection container of this invention comprises a specimen vial and lid, the lid having an adhesive coated disk inserted therein with the lid initially being inverted on the rim of the specimen vial. The specimen vial, lid, and an adhesive backed sealing tape are initially enclosed within a tamper evident plastic wrapper.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of the container assembly of this invention, with the lid inverted on the vial and enclosed in the tamper-evidencing wrapper;
Fig. 2 is a perspective view of the unwrapped container assembly of Figure 1 with the lid removed from its inverted position;
2 ~ 7 ll l~i(3 3 is ~ rspective view of the fill~d container of the apparatus of Fiy l with the protective seals intact; and Fig. 4 is a perspective view of the container of the apparatus of Fig. 1 with the sealing tape broken and the sample being removed from the vial by a pipette.
DESCRIPTION OF THE PREFERRED EMBODIME~rS
The construction of the collection container of this invention, and its use in cooperation with a unique apparatus and method for collecting and presQrving fluid biological evidence, is discussed in detail in U.S. Patent Application Serial No. 07/089,586, filed 26 August 1987. That description is incorporated herein by reference.
The pre-sealed and self-sealing collection container of this invention is shown in Figs. 1-4 and referenced generally therein by the numeral lO.
Referring to Fig. 1, it may be seen that the collection container lO comprises a vial 12 and corresponding lid 14, a sealing tape 16, and a outer tamper evidencing wrapper 18.
2~ 7~74 The inner container or specimen vial 12 is manufactured from a uniform mixture of polystyrene and K-resin, having a generally cylindrical shape and a capacity of approximately 90-100 cc. The specimen vial 12 should be substantially transparent or translucent, or should have a clear window portion extending the height of the specimen vial 12, such that the level or quantity of any fluid content can be readily and visibly observed.
Referring to Figures 1 and 2, the top portion of the specimen vial 12 has a threaded region 20 adjacent the top rim 22 which are sized and aligned to sealing engage threads 24 along the inside of the skirt portion 26 of the lid 14. The lower edge 28 of the skirt 26 of the lid 14 is designed to sealingly contact a sealing collar 30 projecting from the body surface 32 of the specimen container 12 below the threaded region 20 as shown in Figure 3.
An adhesive backed specimen identification label 34 is attached to the outer body surface 32 of the specimen vial 12, the specimen identifying label 34 having the appropriate printed information identifying the source of the specimen vial 12, and suitable space available for identifying the individual or entity 2~27~7~
supplying the fluid evidence contained therein. The specimen vial 12 may also have a plurality of indicators 36 which specify the volume of the specimen, including the minimum and maximum specimen quantity which is necessary for testing. In the case of a transparent or translucent specimen vial 12, the indicators 36 may comprise printed lines on the specimen label 34 positioned and aligned to correspond to the appropriate volume levels associated with the particular dimensions of the container. In the case of human urine specimens, the upper and lower limit indicators 36 should designate approximately 65 cc.
and 25 cc. respectively.
The lid 14 for the specimen vial 12 has a knurled or serrated peripheral edge 38 which aids in securing the lid 14 onto the threaded portion 20 of the vial 12 to form an engaging and fluid-tight seal.
A styrene foam sealing disk 40 is inserted into the bottom side of the lid 14 for the specimen vial 12, the disk 40 having an adhesive coated surface 42, and a non-adhesive coated, opposite surface 44 having generally linear printed lines or text 46 extending across it.
2~2~67~
Initially, the specimen vial 12, lid 14, and foam sealing disk 40 are sealed together within the tamper evidenciny wrapper 18. The tamper evidencing wrapper 18 is formed from a generally brittle, tamper resistent clear plastic thermal shrink-wrap material.
The lid 14 is initially inverted on the vial 12, with the foam sealing disk 40 inserted within the skirt portion 26 and on the bottom side of the lid 14 such that the lower edge 28 of the lid 14 and adhesive surface 42 of the sealing disk 40 are facing upwards, away from the specimen vial 12, and with the top side of the lid 14 resting on and contacting the top rim 22 of the vial 12.
The sealing tape 16 has an adhesive backing and is affixed to a non-adhering backing strip 48 from which it may be removed by peeling the length of the tape 16 the length of the strip 68. The sealing tape 16 has a length sufficient to extend diagonally across the lid 14 of the specimen vial 12 and downwardly on both sides of the specimen vial 12 across the sealing collar 30, and a substantial distance downward along the outer surface 32 of the specimen vial 12. The sealing tape 16 and backing strip 48 are initially folded in half lengthwise, and placed against the 2a~7~
outside surface 32 of the vial and wrapped in the tamper evidencing wrapper 18.
The sealing tape 16 is preferably constructed from a 32# paper with an adhesive coating which will not permit the tape 16 to be removed without visibly tearing or delaminating, and should have a printed safety pattern 50. The sealing tape 16 should extend along the opposing sides of the vial 12 such that the sealing tape 16 cannot be removed without evidencing that removal.
In operation, a person initially obtaining a specimen of biological fluid to be used as evidence will break the tamper-evidencing wrapper 18 on, and unwrap, the container assembly 10. The person removes the lid 14, seal 16, and specimen vial 12 from the protective tamper-resistant wrapper. The biological fluid specimen is then placed directly into the specimen vial 12 up to a level between the indicators 36 showing a sufficient but not excessive quantity of Z0 fluid. The lid 14 is then turned right-side-up and engaged on the rim 22 of the specimen vial 12, and rotated corresponding to the direction of the threads 20, 24 in order to bring the adhesive surface 42 of the foam disk 40 into contact with the rim 22 so as to ~02'7~7~
sealingly engage therewith around the periphery of the rim 22. The lid 14 should therefore be securely fastened to the specimen vial 12 such that the lower edge 28 of the skirt 26 closely confronts or engages the collar 30.
The sealing tape 16 is then peeled from the backing strip 48 and applied to the lid 14 and side surfaces 32 of the specimen vial 12. The sealing tape 16 is firmly pressed into sealing contact with the lid 14 and vial 12 along the entire length of the sealing tape 16, as shown in Fig. 3.
Any necessary information concerning the individual supplying or the person collecting the fluid sample is then recorded on the specimen label 34, and the container assembly 10 may then be packaged as necessary and delivered to the appropriate laboratory or analytical testing facility.
Referring to Fig. 4, it may be seen that a technician or other laboratory personnel who will perform the necessary testing or analysis on the fluid evidence breaks the sealing tape 16 on the sealed specimen vial 12 and lid 14, and completely unscrews the lid 14 from the specimen vial 12. The technician then determines that the foam sealing disk 40 is - 202 7~7~
intact has not been tampered with or disturbed, and removes all or a portion of the foam sealing disk 40 from the rim 22 of the specimen vial 12 by peeling it therefrom, or else punctures the disk 40 with an appropriate instrument. The technician then removes aliquots of the fluid sample using a pipette 52 or other suitable instrument. The technician may then perform the necessary analysis on the aliquots of fluid removed from the specimen vial 12.
In a varying embodiment of the apparatus for collecting and preserving fluid biological evidence 10 described above, a tablet 54 or 1000 mg. portion of granular sodium fluoride, or other suitable chemical agent which will not interfere with the analytical testing, may initially be placed within the specimen vial 12 and which will function to preserve the fluid sample until such time that the specimen vial 12 is unsealed and opened for removal of the contents.
In the preferred embodiment, a liquid crystal temperature indicating strip 56 is attached to the exterior surface 32 of the vial 12 near the bottom edge 58 thereof.
The temperature indicating strip 56 may be of any type known to the art and suitable for such purposes, 2Q2'~7~
however an off-set liquid crystal thermal monitor having a liquid crystal initial activation temperature approximately 4 below the desired event temperature, with a range of event temperatures from 88F-102F, has proven effective. A representative example of such a thermal monitor includes those manufactured by Hallcrest, Liquid Crystal Division, of Glenview, Illinois, and referenced generally by Lot J-03.
When a sample of biological fluid such as urine is placed into the vial 12, it will generally be at normal body temperature. The sample contacting the vial 12 will transmit that heat rapidly through the side wall 32 of the vial 12, and heat the temperature indicating strip 56. If, as an example, the sample were 98F, a small triangular liquid crystal temperature event indicator or display 60 under one of the line of corresponding event indicating numerals 62 (~98N in the example and drawing Figures) on the temperature indicating strip 56 would turn a light color, such as green, blue, or gold, which would be readily visible or Nglowing" against the darker background of the temperature indicating strip 56 (inverse in drawing Figures.) It may also occur that adjacent numerals, such as Ng6" and N100," will also .
, ., 20~67~
turn lighter color, but the numeral 62 corresponding to the closest event or actual temperature will generally be a distinct color and a higher intensity.
From this indication, a person taking the sample can readily determine whether the sample is within a predetermined acceptable temperature range to suggest that the sample was authentic. All of the triangular event temperature indicators 60 will return to approximately the same color as the background when the sample cools to a few degrees below the lowest numeral 62 on the temperature indicating strip 56.
While the preferred embodiments of the particular inven,tion have been described above in relation to the referenced drawing figures, it is understood that the apparatus and method of using the apparatus described above may be modified and changed without departing from the spirit and scope of the appended claims.
PRE-SEALED AND SELF-SEALING CONTAINER FO~ THE COLLECTION
AND PRESERVATION OF FLU D BIOLOGICAL EVIDENCE
BACKGROUND OF THE INVENTION
This invention relates generally to a container for collecting, transporting, and preserving specimens of biological fluid for use as evidence, and particularly for collecting urine specimens and supplying those specimens to a remote laboratory facility for analytical testing.
As described in the above referenced co-pending application, the results of the most careful analytical drug or chemical testing may be affected by contaminants in the sampling or testing containers, including prescription and non-prescription medications or reactive chemical compounds, and the testing procedures themselves may often be attacked on a chain of custody theory in much the same manner as criminal evidence.
,, .
2~2~67~
There is a vested interest on the part of employers and law enforcement agencies who perform routine drug testing to ensure the accuracy and reliability of those tests, and to similarly guarantee that the testing equipment will not be tampered with or questioned. The public, particularly individuals who submit to drug testing as a prerequisite to employment and who are not drug users or abusers, similarly have an interest in accurate testing and in ensuring that the testing methods prevent intentional tampering or minimize human error wherever possible.
While the currently employed methods vary depending upon the testing authority and the equipment provided, there are several common drawbacks to each method which have been identified.
Primarily, while the samples may sometimes be sealed in specimen containers once they have been obtained from the individual being tested, it cannot be verified that the containers being used for the testing were not tampered with, or were free of contaminants, prior to the testing. Similarly, the chaln of custody prior to testing cannot be verified.
, $
2~2~7~
The testing equipment usually provides an ineffective seal for the specimen container, and only one seal when such is provided. The seal may frequently be neglected or omitted by the person supervising the testing. The person being tested often does not have an opportunity to inspect the testing equipment, an important factor to consider for purposes of belaying the apprehensions of the person being testing, or as a means of additional verification of the testing procedures. While a supervising person may be instructed in the proper testing and control procedures, there is always a chance of human error or the possibility that the supervisors will not understand the legal significance lS of the various steps of the process, and so the steps should be made as uniform, repeatable, and as automatic as possible.
Tamper evident seals for plastic containers, such as those u~ed in food packaging, are well known, a representative example being given by United States Patent No. 4,087,018. Additional devices for securing a fluid container and evidencing tampering are known, such as those sealing closures disclosed in United States Patent Nos. 1,996,682 and 4,262,814 and the .
2~27~7~
related art. Another sealed container disposed within a second sealed package is disclosed in United States Patent No. 985,850.
Each of these patents, while being representative of a broad field of art and disclosing a method of identifying or evidencing whether a aontainer has been tampered with, each prove to have one or more defects making them unsuitable for application to the process of collecting a fluid biological sample for use as lo evidence.
Those containers in which an item or product is sealed so as to evidence tampering already contain the item to be protected. There is no provision for the container to exist in a tamper evidencing state prior to the product being placed therein, or for resealing the tamper evidencing closure once the item has been placed in the container. Similarly, there is no apparatus which automatically creates a new tamper evident seal when the container is closed once the original seal is broken, nor that enhances or facilitates verifying the chain of custody of the container.
United States Patent No. 4,362,698 discloses a -permanently sealed laboratory vessel used in blood - 2027~7~
....
testing, however the manner of providing the closure to this vessel is unsuitable for use in the collection of biological samples in the field, or for preserving those samples during transportation to the testing facility.
BRIEF SUMMARY OF THE INVENTION
It is therefore one object of this invention to design a collection container for fluid biological samples which may be used to transport those samples to a remote laboratory facility for analytical testing, and which eliminates many of the defects in the chain of custody associated with existing procedures, particularly the control of the sample container prior to the actual aollection process.
It is another object of this invention to design the above apparatus such that it is highly tamper resistant along the entire chain of supply to the colle¢tion site, and transport to the testing ~0 facility.
It is a further object of this invention to design the above apparatus such that it promotes uniformity in testing, and encourages those supervising the drug testing to take the reasonable and necessary ~027~7~
precautions to ensure the accuracy and reliability of such tests.
It is a still another object of this invention to design the above apparatus such that it includes uniform, repeated, and automatic procedures for preserving the collection sample in a tamper resistant container.
Briefly described, the collection container of this invention comprises a specimen vial and lid, the lid having an adhesive coated disk inserted therein with the lid initially being inverted on the rim of the specimen vial. The specimen vial, lid, and an adhesive backed sealing tape are initially enclosed within a tamper evident plastic wrapper.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of the container assembly of this invention, with the lid inverted on the vial and enclosed in the tamper-evidencing wrapper;
Fig. 2 is a perspective view of the unwrapped container assembly of Figure 1 with the lid removed from its inverted position;
2 ~ 7 ll l~i(3 3 is ~ rspective view of the fill~d container of the apparatus of Fiy l with the protective seals intact; and Fig. 4 is a perspective view of the container of the apparatus of Fig. 1 with the sealing tape broken and the sample being removed from the vial by a pipette.
DESCRIPTION OF THE PREFERRED EMBODIME~rS
The construction of the collection container of this invention, and its use in cooperation with a unique apparatus and method for collecting and presQrving fluid biological evidence, is discussed in detail in U.S. Patent Application Serial No. 07/089,586, filed 26 August 1987. That description is incorporated herein by reference.
The pre-sealed and self-sealing collection container of this invention is shown in Figs. 1-4 and referenced generally therein by the numeral lO.
Referring to Fig. 1, it may be seen that the collection container lO comprises a vial 12 and corresponding lid 14, a sealing tape 16, and a outer tamper evidencing wrapper 18.
2~ 7~74 The inner container or specimen vial 12 is manufactured from a uniform mixture of polystyrene and K-resin, having a generally cylindrical shape and a capacity of approximately 90-100 cc. The specimen vial 12 should be substantially transparent or translucent, or should have a clear window portion extending the height of the specimen vial 12, such that the level or quantity of any fluid content can be readily and visibly observed.
Referring to Figures 1 and 2, the top portion of the specimen vial 12 has a threaded region 20 adjacent the top rim 22 which are sized and aligned to sealing engage threads 24 along the inside of the skirt portion 26 of the lid 14. The lower edge 28 of the skirt 26 of the lid 14 is designed to sealingly contact a sealing collar 30 projecting from the body surface 32 of the specimen container 12 below the threaded region 20 as shown in Figure 3.
An adhesive backed specimen identification label 34 is attached to the outer body surface 32 of the specimen vial 12, the specimen identifying label 34 having the appropriate printed information identifying the source of the specimen vial 12, and suitable space available for identifying the individual or entity 2~27~7~
supplying the fluid evidence contained therein. The specimen vial 12 may also have a plurality of indicators 36 which specify the volume of the specimen, including the minimum and maximum specimen quantity which is necessary for testing. In the case of a transparent or translucent specimen vial 12, the indicators 36 may comprise printed lines on the specimen label 34 positioned and aligned to correspond to the appropriate volume levels associated with the particular dimensions of the container. In the case of human urine specimens, the upper and lower limit indicators 36 should designate approximately 65 cc.
and 25 cc. respectively.
The lid 14 for the specimen vial 12 has a knurled or serrated peripheral edge 38 which aids in securing the lid 14 onto the threaded portion 20 of the vial 12 to form an engaging and fluid-tight seal.
A styrene foam sealing disk 40 is inserted into the bottom side of the lid 14 for the specimen vial 12, the disk 40 having an adhesive coated surface 42, and a non-adhesive coated, opposite surface 44 having generally linear printed lines or text 46 extending across it.
2~2~67~
Initially, the specimen vial 12, lid 14, and foam sealing disk 40 are sealed together within the tamper evidenciny wrapper 18. The tamper evidencing wrapper 18 is formed from a generally brittle, tamper resistent clear plastic thermal shrink-wrap material.
The lid 14 is initially inverted on the vial 12, with the foam sealing disk 40 inserted within the skirt portion 26 and on the bottom side of the lid 14 such that the lower edge 28 of the lid 14 and adhesive surface 42 of the sealing disk 40 are facing upwards, away from the specimen vial 12, and with the top side of the lid 14 resting on and contacting the top rim 22 of the vial 12.
The sealing tape 16 has an adhesive backing and is affixed to a non-adhering backing strip 48 from which it may be removed by peeling the length of the tape 16 the length of the strip 68. The sealing tape 16 has a length sufficient to extend diagonally across the lid 14 of the specimen vial 12 and downwardly on both sides of the specimen vial 12 across the sealing collar 30, and a substantial distance downward along the outer surface 32 of the specimen vial 12. The sealing tape 16 and backing strip 48 are initially folded in half lengthwise, and placed against the 2a~7~
outside surface 32 of the vial and wrapped in the tamper evidencing wrapper 18.
The sealing tape 16 is preferably constructed from a 32# paper with an adhesive coating which will not permit the tape 16 to be removed without visibly tearing or delaminating, and should have a printed safety pattern 50. The sealing tape 16 should extend along the opposing sides of the vial 12 such that the sealing tape 16 cannot be removed without evidencing that removal.
In operation, a person initially obtaining a specimen of biological fluid to be used as evidence will break the tamper-evidencing wrapper 18 on, and unwrap, the container assembly 10. The person removes the lid 14, seal 16, and specimen vial 12 from the protective tamper-resistant wrapper. The biological fluid specimen is then placed directly into the specimen vial 12 up to a level between the indicators 36 showing a sufficient but not excessive quantity of Z0 fluid. The lid 14 is then turned right-side-up and engaged on the rim 22 of the specimen vial 12, and rotated corresponding to the direction of the threads 20, 24 in order to bring the adhesive surface 42 of the foam disk 40 into contact with the rim 22 so as to ~02'7~7~
sealingly engage therewith around the periphery of the rim 22. The lid 14 should therefore be securely fastened to the specimen vial 12 such that the lower edge 28 of the skirt 26 closely confronts or engages the collar 30.
The sealing tape 16 is then peeled from the backing strip 48 and applied to the lid 14 and side surfaces 32 of the specimen vial 12. The sealing tape 16 is firmly pressed into sealing contact with the lid 14 and vial 12 along the entire length of the sealing tape 16, as shown in Fig. 3.
Any necessary information concerning the individual supplying or the person collecting the fluid sample is then recorded on the specimen label 34, and the container assembly 10 may then be packaged as necessary and delivered to the appropriate laboratory or analytical testing facility.
Referring to Fig. 4, it may be seen that a technician or other laboratory personnel who will perform the necessary testing or analysis on the fluid evidence breaks the sealing tape 16 on the sealed specimen vial 12 and lid 14, and completely unscrews the lid 14 from the specimen vial 12. The technician then determines that the foam sealing disk 40 is - 202 7~7~
intact has not been tampered with or disturbed, and removes all or a portion of the foam sealing disk 40 from the rim 22 of the specimen vial 12 by peeling it therefrom, or else punctures the disk 40 with an appropriate instrument. The technician then removes aliquots of the fluid sample using a pipette 52 or other suitable instrument. The technician may then perform the necessary analysis on the aliquots of fluid removed from the specimen vial 12.
In a varying embodiment of the apparatus for collecting and preserving fluid biological evidence 10 described above, a tablet 54 or 1000 mg. portion of granular sodium fluoride, or other suitable chemical agent which will not interfere with the analytical testing, may initially be placed within the specimen vial 12 and which will function to preserve the fluid sample until such time that the specimen vial 12 is unsealed and opened for removal of the contents.
In the preferred embodiment, a liquid crystal temperature indicating strip 56 is attached to the exterior surface 32 of the vial 12 near the bottom edge 58 thereof.
The temperature indicating strip 56 may be of any type known to the art and suitable for such purposes, 2Q2'~7~
however an off-set liquid crystal thermal monitor having a liquid crystal initial activation temperature approximately 4 below the desired event temperature, with a range of event temperatures from 88F-102F, has proven effective. A representative example of such a thermal monitor includes those manufactured by Hallcrest, Liquid Crystal Division, of Glenview, Illinois, and referenced generally by Lot J-03.
When a sample of biological fluid such as urine is placed into the vial 12, it will generally be at normal body temperature. The sample contacting the vial 12 will transmit that heat rapidly through the side wall 32 of the vial 12, and heat the temperature indicating strip 56. If, as an example, the sample were 98F, a small triangular liquid crystal temperature event indicator or display 60 under one of the line of corresponding event indicating numerals 62 (~98N in the example and drawing Figures) on the temperature indicating strip 56 would turn a light color, such as green, blue, or gold, which would be readily visible or Nglowing" against the darker background of the temperature indicating strip 56 (inverse in drawing Figures.) It may also occur that adjacent numerals, such as Ng6" and N100," will also .
, ., 20~67~
turn lighter color, but the numeral 62 corresponding to the closest event or actual temperature will generally be a distinct color and a higher intensity.
From this indication, a person taking the sample can readily determine whether the sample is within a predetermined acceptable temperature range to suggest that the sample was authentic. All of the triangular event temperature indicators 60 will return to approximately the same color as the background when the sample cools to a few degrees below the lowest numeral 62 on the temperature indicating strip 56.
While the preferred embodiments of the particular inven,tion have been described above in relation to the referenced drawing figures, it is understood that the apparatus and method of using the apparatus described above may be modified and changed without departing from the spirit and scope of the appended claims.
Claims (36)
1. A container assembly for the collection of a sample of biological fluid for evidentiary purposes, said container assembly comprising: a vial, said vial defining an aperture and a receptacle region for containing the sample;
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a removable closure over said aperture; sealing means associated with the bottom side of said lid for producing a removable fluid tight seal covering said aperture; and a tamper-evidencing wrapper, said tamper-evidencing wrapper enclosing said vial, said lid, and said sealing means, said lid being inverted upon said vial with the bottom side disposed away from said vial such that said sealing means does not form the fluid tight seal covering said aperture.
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a removable closure over said aperture; sealing means associated with the bottom side of said lid for producing a removable fluid tight seal covering said aperture; and a tamper-evidencing wrapper, said tamper-evidencing wrapper enclosing said vial, said lid, and said sealing means, said lid being inverted upon said vial with the bottom side disposed away from said vial such that said sealing means does not form the fluid tight seal covering said aperture.
2. The container assembly of claim 1 wherein the vial has a peripheral rim adjacent to and surrounding the aperture, said lid having a peripheral skirt surrounding the bottom side of the lid, said sealing means comprising: a disk, said disk being connected to the lid and disposed on the bottom side of the lid and generally surrounded by said peripheral skirt, said disk having a peripheral edge substantially conforming to the peripheral rim of the vial, said disk further having a surface coated with an adhesive, said adhesive extending across said surface of said disk at least around a portion of said disk adjacent to said peripheral edge of said disk, whereby said adhesive forms a fluid tight seal between said disk and the rim of the vial when the tamper-evidencing wrapper is removed and the surface of the disk coated with the adhesive is pressed into contact with the rim of the vial.
3. The container assembly of claim 2 wherein the rim is generally circular and the disk is generally circular, the disk and the rim each have a diameter, said diameter of the disk being slightly greater than or substantially equal to said diameter of the rim.
4. The container assembly of claim 2 wherein the adhesive covers substantially the entire surface of the disk.
5. The container assembly of claim 2 wherein the disk remains adhered to the rim of the vial in covering relation to the aperture if the lid is mounted on the vial and then subsequently removed from the vial.
6. The container assembly of claim 1 wherein the vial has a pair of opposing sides adjacent the lid when the lid is mounted upon the vial, said container assembly further comprising: a tamper-evidencing sealing tape, said tamper-evidencing sealing tape having an adhesive backing and a length and two ends, said length being sufficient such that said tamper-evidencing sealing tape may be attached to the vial and the lid with said adhesive backing so as to extend across the lid with each of said ends of said tamper-evidencing sealing tape extending substantially downward over one of the opposing sides of the vial.
7. The container assembly of claim 6 wherein the tamper-evidencing sealing tape is initially wrapped within the tamper-evidencing wrapper.
8. The container assembly of claim 7 wherein the vial has a side wall and the tamper-evidencing sealing tape is initially disposed between the side wall and the tamper-evidencing wrapper.
9. The container assembly of claim 1 wherein the sample is to comprise a volume within a predetermined range of acceptable volumes between a minimum volume and a maximum volume to be viewed by a user, said container assembly further comprising: indicator means associated with said vial for identifying by visual comparison the volume of the sample relative to the minimum volume and the maximum volume, whereby the user may determine by visual inspection whether the volume of the sample is within the predetermined range of acceptable volumes.
10. The container assembly of claim 9 wherein the vial has substantially transparent portion, and said indicator means comprises: a label attached to the vial, said label having a marking adjacent the transparent portion corresponding to the maximum volume, said label further having a marking adjacent the transparent portion corresponding to the minimum volume.
11. The container assembly of claim 1 wherein the vial contains an aliquot of granular sodium fluoride.
12. The container assembly of claim 11 wherein the aliquot of sodium fluoride has a weight of approximately one gram.
13. The container assembly of claim 1 wherein the vial has a side wall, said container assembly further comprising:
temperature indicating means attached to the side wall of the vial for indicating an event temperature associated with the temperature of the sample.
temperature indicating means attached to the side wall of the vial for indicating an event temperature associated with the temperature of the sample.
14. The container assembly of claim 13 wherein the temperature indicating means includes a plurality of visible liquid crystal displays, each said display corresponding to a predetermined temperature within a selected range of temperatures.
15. The container assembly of claim 14 wherein the range of temperatures extends from 88°F to 102°F.
16. The container assembly of claim 13 wherein the side wall of the vial has an exterior surface and the vial has a bottom, the temperature indicating means being contained on a strip, said strip being attached to said exterior surface of the side wall of the vial proximate to said bottom thereof.
17. A container assembly for the collection of a sample of a biological fluid for evidentiary purposes, said container assembly to be used by a user, said container assembly comprising:
a vial, said vial defining an aperture and a receptacle region for containing the sample;
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a closure over said aperture;
sealing means associated with said bottom side of said lid for producing a seal covering said aperture; and a wrapper, said wrapper initially enclosing said vial, said lid, and said sealing means, at least a portion of said lid being disposed between said sealing means and said aperture of said vial such that said sealing means does not form said seal covering said aperture unless the user selectively mounts said lid on said vial, said wrapper deterring tampering with or contamination of said vial prior to said vial being removed from said wrapper by the user.
a vial, said vial defining an aperture and a receptacle region for containing the sample;
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a closure over said aperture;
sealing means associated with said bottom side of said lid for producing a seal covering said aperture; and a wrapper, said wrapper initially enclosing said vial, said lid, and said sealing means, at least a portion of said lid being disposed between said sealing means and said aperture of said vial such that said sealing means does not form said seal covering said aperture unless the user selectively mounts said lid on said vial, said wrapper deterring tampering with or contamination of said vial prior to said vial being removed from said wrapper by the user.
18. The container assembly of claim 17 wherein the vial has a peripheral rim adjacent to and surrounding the aperture, the lid having a peripheral skirt surrounding the bottom side of the lid, said sealing means comprising:
a disk, said disk being connected to the lid and disposed on the bottom side of the lid and generally surrounded by the peripheral skirt, said disk having a peripheral edge substantially conforming to the peripheral rim of the vial, said disk further having a surface coated with an adhesive, said adhesive extending across said surface of said disk at least around a portion of said disk adjacent to said peripheral edge of said disk, whereby said adhesive forms a substantially fluid tight seal between said disk and the rim of the vial when the wrapper is removed and the surface of the disk coated with the adhesive is pressed into contact with the rim of the vial.
a disk, said disk being connected to the lid and disposed on the bottom side of the lid and generally surrounded by the peripheral skirt, said disk having a peripheral edge substantially conforming to the peripheral rim of the vial, said disk further having a surface coated with an adhesive, said adhesive extending across said surface of said disk at least around a portion of said disk adjacent to said peripheral edge of said disk, whereby said adhesive forms a substantially fluid tight seal between said disk and the rim of the vial when the wrapper is removed and the surface of the disk coated with the adhesive is pressed into contact with the rim of the vial.
19. The container assembly of claim 18 wherein the rim is generally circular and the disk is generally circular, the disk and the rim each have a diameter, said diameter of the disk being slightly greater than or substantially equal to said diameter of the rim.
20. The container assembly of claim 18 wherein the adhesive covers substantially the entire surface of the disk.
21. The container assembly of claim 18 wherein the disk remains adhered to the rim of the vial in covering relation to the aperture if the lid is mounted on the vial and then subsequently removed from the vial.
22. The container assembly of claim 17 wherein the vial has a pair of opposing sides adjacent the lid when the lid is mounted upon the vial, said container assembly further comprising:
a sealing tape, said sealing tape having an adhesive backing and a length and two ends, said length being sufficient such that said sealing tape may be attached to the vial and the lid with said adhesive backing so as to extend across the lid with each of said ends of said sealing tape extending substantially downward over one of the opposing sides of the vial.
a sealing tape, said sealing tape having an adhesive backing and a length and two ends, said length being sufficient such that said sealing tape may be attached to the vial and the lid with said adhesive backing so as to extend across the lid with each of said ends of said sealing tape extending substantially downward over one of the opposing sides of the vial.
23. The container assembly of claim 22 wherein the sealing tape is initially wrapped within the wrapper.
24. The container assembly of claim 22 wherein the vial has a side wall and the sealing tape is initially disposed between said side wall and the wrapper.
25. The container assembly of claim 17 wherein the sample is to comprise a volume within a predetermined range of acceptable volumes between a minimum volume and a maximum volume, said container assembly further comprising:
indicator means associated with the vial for identifying by visual comparison the volume of the fluid sample relative to the minimum volume and the maximum volume, whereby the user may determine by visual inspection whether the volume of the sample is within the predetermined range of acceptable volumes.
indicator means associated with the vial for identifying by visual comparison the volume of the fluid sample relative to the minimum volume and the maximum volume, whereby the user may determine by visual inspection whether the volume of the sample is within the predetermined range of acceptable volumes.
26. The apparatus of claim 25 wherein the vial has a substantially transparent portion, and the indicator means comprises:
a label attached to the vial, said label having a marking adjacent the transparent portion corresponding to the maximum volume, said label further having a marking adjacent the transparent portion corresponding to the minimum volume.
a label attached to the vial, said label having a marking adjacent the transparent portion corresponding to the maximum volume, said label further having a marking adjacent the transparent portion corresponding to the minimum volume.
27. A container assembly for the collection of a sample of a biological fluid for evidentiary purposes, said container assembly to be used by a user, said container assembly comprising:
a vial, said vial defining an aperture and a receptacle region for containing the sample;
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a closure over said aperture;
sealing means associated with said bottom side of said lid for producing a seal covering said aperture; and a wrapper, said wrapper initially enclosing said vial, said lid, and said sealing means, said lid being oriented and disposed within said wrapper and relative to said vial such that said sealing means does not form said seal covering said aperture unless the user selectively mounts said lid on said vial, said wrapper deterring tampering with or contamination of said vial prior to said vial being removed from said wrapper by the user.
a vial, said vial defining an aperture and a receptacle region for containing the sample;
a lid, said lid having a top side and a bottom side and being engagingly mountable on said vial to form a closure over said aperture;
sealing means associated with said bottom side of said lid for producing a seal covering said aperture; and a wrapper, said wrapper initially enclosing said vial, said lid, and said sealing means, said lid being oriented and disposed within said wrapper and relative to said vial such that said sealing means does not form said seal covering said aperture unless the user selectively mounts said lid on said vial, said wrapper deterring tampering with or contamination of said vial prior to said vial being removed from said wrapper by the user.
28. The container assembly of claim 27 wherein the vial has a peripheral rim adjacent to and surrounding the aperture, the lid having a peripheral skirt surrounding the bottom side of the lid, said sealing means comprising:
a disk, said disk being connected to the lid and disposed on the bottom side of the lid and generally surrounded by the peripheral skirt, said disk having a peripheral edge substantially conforming to the peripheral rim of the vial, said disk further having a surface coated with an adhesive, said adhesive extending across said surface of said disk at least around a portion of said disk adjacent to said peripheral edge of said disk, whereby said adhesive forms a substantially fluid tight seal between said disk and the rim of the vial when the wrapper is removed and the surface of the disk coated with the adhesive is pressed into contact with the rim of the vial.
a disk, said disk being connected to the lid and disposed on the bottom side of the lid and generally surrounded by the peripheral skirt, said disk having a peripheral edge substantially conforming to the peripheral rim of the vial, said disk further having a surface coated with an adhesive, said adhesive extending across said surface of said disk at least around a portion of said disk adjacent to said peripheral edge of said disk, whereby said adhesive forms a substantially fluid tight seal between said disk and the rim of the vial when the wrapper is removed and the surface of the disk coated with the adhesive is pressed into contact with the rim of the vial.
29. The container assembly of claim 28 wherein the rim is generally circular and the disk is generally circular, the disk and the rim each have a diameter, said diameter of the disk being slightly greater than or substantially equal to said diameter of the rim.
30. The container assembly of claim 28 wherein the adhesive covers substantially the entire surface of the disk.
31. The container assembly of claim 28 wherein the disk remains adhered to the rim of the vial in covering relation to the aperture if the lid is mounted on the vial and then subsequently removed from the vial.
32. The container assembly of claim 27 wherein the vial has a pair of opposing sides adjacent the lid when the lid is mounted upon the vial, said container assembly further comprising:
a sealing tape, said sealing tape having an adhesive backing and a length and two ends, said length being sufficient such that said sealing tape may be attached to the vial and the lid with said adhesive backing so as to extend across the lid with each of said ends of said sealing tape extending substantially downward over one of the opposing sides of the vial.
a sealing tape, said sealing tape having an adhesive backing and a length and two ends, said length being sufficient such that said sealing tape may be attached to the vial and the lid with said adhesive backing so as to extend across the lid with each of said ends of said sealing tape extending substantially downward over one of the opposing sides of the vial.
33. The container assembly of claim 32 wherein the sealing tape is initially wrapped within the wrapper.
34. The container assembly of claim 32 wherein the vial has a side wall and the sealing tape is initially disposed between said side wall and the wrapper.
35. The container assembly of claim 27 wherein the sample is to comprise a volume within a predetermined range of acceptable volumes between a minimum volume and a maximum volume, said container assembly further comprising:
indicator means associated with the vial for identifying by visual comparison the volume of the fluid sample relative to the minimum volume and the maximum volume, whereby the user may determine by visual inspection whether the volume of the sample is within the predetermined range of acceptable volumes.
indicator means associated with the vial for identifying by visual comparison the volume of the fluid sample relative to the minimum volume and the maximum volume, whereby the user may determine by visual inspection whether the volume of the sample is within the predetermined range of acceptable volumes.
36. The apparatus of claim 35 wherein the vial has a substantially transparent portion, and the indicator means comprises:
a label attached to the vial, said label having a marking adjacent the transparent portion corresponding to the maximum volume, said label further having a marking adjacent the transparent portion corresponding to the minimum volume.
a label attached to the vial, said label having a marking adjacent the transparent portion corresponding to the maximum volume, said label further having a marking adjacent the transparent portion corresponding to the minimum volume.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2027674 CA2027674A1 (en) | 1990-10-15 | 1990-10-15 | Pre-sealed and self-sealing container for the collection and preservation of fluid biological evidence |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2027674 CA2027674A1 (en) | 1990-10-15 | 1990-10-15 | Pre-sealed and self-sealing container for the collection and preservation of fluid biological evidence |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2027674A1 true CA2027674A1 (en) | 1992-04-16 |
Family
ID=4146160
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2027674 Abandoned CA2027674A1 (en) | 1990-10-15 | 1990-10-15 | Pre-sealed and self-sealing container for the collection and preservation of fluid biological evidence |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2027674A1 (en) |
-
1990
- 1990-10-15 CA CA 2027674 patent/CA2027674A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |