Abstract:
A biological sample containment system and method are provided that include a container for storing the biological sample and an indicator affixed to the container for displaying at least one measured characteristics of the container or sample, wherein measurement of the characteristic is commenced by activation of the indicator. In yet another embodiment of the invention, a biological sample containment system and method are provided that include a container for collecting a biological sample and a label affixed to the container, wherein information relating to the biological sample or container is situated on the label and at least a portion of said information is situated on a face of the label that is affixed to the container.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 12/278,642 entitled “Biological Specimen Collection and Storage Devices”, filed Jul. 8, 2010, which is a national stage application filed under 35 U.S.C. §371 of International Patent Application No. PCT/US2007/003437 entitled “Improved Specimen Collection and Storage Devices and Methods Relating Thereto”, filed Feb. 8, 2007, which claims priority to U.S. Provisional Application No. 60/771,923 filed Feb. 8, 2006, the entire disclosures of each of which are herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to systems and methods for providing information relating to vessels for collecting biological fluid samples from a patient. 
       BACKGROUND 
       [0003]    Biological sample collection containers, such as blood collection containers, are well-known in the medical arts. Biological sample collection containers are used to store a sample obtained by a healthcare professional from a patient until the sample is ready to be tested or used for other purposes. 
         [0004]    When collecting biological samples in collection containers, it is often important that the container and/or sample are not exposed to a temperature that exceeds a certain threshold. In addition, it is sometimes important that the container is used within a certain timeframe upon manufacture, shipment, or some other event. In addition, it may be important to know the amount of time that has transpired after collection of the sample into the container. 
         [0005]    In addition, identifying other characteristics of the sample and/or container may be useful to the healthcare practitioner. For example, identifying the integrity of the sample, whether the sample has been subjected to appropriate procedures (i.e., mixing) or whether the appropriate amount of sample has been collected may be significant. 
         [0006]    Currently, biological sample containers typically include a reservoir portion and a closure portion and contains some type of identifying information on the container. Such information, however, is often quite limited (such as limited to container type, patient identifiers and container identifiers) and does not effectively address the issues described above in connection with container and/or sample integrity. 
       SUMMARY OF THE INVENTION 
       [0007]    Improved biological specimen containers facilitate the handling of such samples to, for instance, improve sample and container rejection criteria, increase the number and percentage of high quality samples, improve data collection and generation, monitor potential container and sample problems, and improve container and sample quality control procedures. 
         [0008]    Accordingly, in one embodiment of the invention, a biological sample containment system and method are provided that include a container for storing the biological sample and an indicator affixed to the container for displaying at least one measured characteristics of the container or sample, wherein measurement of the characteristic is commenced by activation of the indicator. The biological sample containment system and method may further include a cover associated with the indicator, wherein measurement of the characteristic is commenced upon manipulation and/or removal of at least a portion of the cover and/or upon exposure to air or light. The characteristic that is measured may relate to the temperature to which the container is exposed, the age of the container, the amount of mixing to which the biological sample has been subjected, the time that has transpired since the biological sample has been introduced or stored by the container, the amount of time that has transpired since a user or machine performed a task related to the container, or the like. 
         [0009]    In another embodiment of the invention, a biological sample containment system and method are provided that include a container for storing the biological sample and a colored scale affixed to the container, wherein the colored scale facilitates identification of at least one characteristic of the biological sample, such as the level of hemolysis associated with the biological sample. 
         [0010]    In yet another embodiment of the invention, a biological sample containment system and method are provided that include a container for collecting a biological sample and a label affixed to the container, wherein information relating to the biological sample or container is situated on the label and at least a portion of said information is situated on a face of the label that is affixed to the container. In one instance, the information may relate to whether the container is filled with the biological sample at a desired level. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1A  illustrates a biological sample collection container; 
           [0012]      FIG. 1B  illustrates a biological sample collection container having a characteristic labeling system, in accordance with an embodiment of the invention; 
           [0013]      FIG. 1C  illustrates a characteristic label, in accordance with an embodiment of the invention, for use in connection with a biological sample container such as the container illustrated in  FIG. 1A ; 
           [0014]      FIG. 2  illustrates a characteristic label, in accordance with another embodiment of the invention, for use in connection with a biological sample container such as the container illustrated in  FIG. 1A ; 
           [0015]      FIG. 3A  illustrates a biological sample collection container bearing sample and container characteristic indicators, in accordance with an embodiment of the invention; and 
           [0016]      FIG. 3B  illustrates a biological sample collection container bearing a fill range indicator, in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]      FIG. 1A  illustrates a biological sample collection container  10 . Container  10  includes sample collection tube  20  (such as chemistry sample tube, coagulation sample tube and hematology sample tube, etc.) and closure  16 . In the illustrated embodiment, tube  20  is generally cylindrical and may be made of one or more of the following representative materials: polypropylene, polyethylene terapthalate (PET), glass, or combinations thereof. In addition, closure  16  may be made of a resealable elastomeric polymer and additionally may comprise a polymer cap integral to the resealable elastomeric polymer. In other instances, container  10  may comprise a vessel of different shape (i.e., other than cylindrical) and, in some instances, may not be a tube. For example, container  10  may comprise a collection cup, bag, or the like. 
         [0018]    Referring to  FIGS. 1A and 1B , collection system  10  further includes a characteristic labeling system, which in accordance with an embodiment of the invention, comprises characteristic label  90 A and label cover  80 . In accordance with an embodiment of the invention, characteristic label  90 A is configured to track the amount of time that has transpired upon removal (i.e., peeling) and/or piercing (with, for example, a non-patient blood collection needle) of label cover  80 . 
         [0019]    Label cover  80 , in accordance with an embodiment of the invention, is designed to cover and protect characteristic label  90 A. In one instance, label cover  80  has a flap for easy gripping to facilitate removal. In addition, label cover  80  has an adhesive applied to the portion facing characteristic  90 A either on its entire face or a portion of such face (such as a perimeter). 
         [0020]    Characteristic label  90 A may, in accordance with an embodiment of the invention, use visually changing paper (“VCP”) technology that is triggered by a triggering event, such as when label cover  80  is removed or pierced. The triggering event causes the VCP technology to transition from an inactivated state to an activated state. The visually changing paper technology utilized on characteristic label  90 A may also be triggered by triggering event such as a surface modification, when for instance a label cover is applied to all or a portion of characteristic label  90 A, or alternately when all or a portion of the characteristic label  90 A has been subjected to a localized chemical environment change that commences or triggers a visual response to such change in localized chemical environment. An example of a localized chemical environment change may include the addition of a chemical or solution to portions of characteristic label  90 A. In one instance, such removal or piercing of label cover  80  exposes characteristic label  90 A to air which initiates a visually viewable or interpretable response correlating to time monitoring or tracking. In another instance, such adherence of a label cover  80  to characteristic label  90 A may initiate a visually viewable or interpretable response correlating to time monitoring or tracking. Specifically, an activator matrix integral to the label cover  80  comprising, for example, an organic acid may migrate to an indicator matrix integral to characteristic label  90   a  comprising, for example, an acid-base dye indicator. Alternatively, exposing characteristic label  90 A to light (by removal or piercing of cover  80 ) may initiate time monitoring. Further, removal of label cover  80  may begin a chemical reaction visible to a user directly or through the use of an optical detection mechanism. 
         [0021]    Referring to  FIG. 1C , in accordance with an embodiment of the invention, characteristic label  90 A is configured to identify one or multiple interpretable time periods measured from the time at which a triggering event has been deliberately commenced. For instance, the following time periods and their respective time period indicators may be determined to have transpired from the triggering event such as exposure of such label upon removal of label cover  80 : a half-hour ( 92   a ), 2 hours ( 92   b ), 3 hours ( 92   c ), 6 hours ( 92   d ), 12 hours ( 92   e ), 24 hours ( 92   f ), 48 hours ( 92   g ), 96 hours ( 92   h ). Label  90 A may be configured to identify other time intervals further including, for example, days. 
         [0022]    In accordance with an embodiment of the invention, characteristic label  90 A is exposed at time relevant to the drawing of a sample into tube  20 . By subsequently viewing characteristic label  90 A, the approximate time between drawing of the sample and a subsequent event and monitoring event (such as refrigeration, testing, etc.) may be determined or ascertained. In one instance, label  90 A is configured such that as the number of hours transpires (from a triggering event such as time of exposure), the color of the label in the region of such time periods changes. In another instance, label  90 A comprises a plurality of different time period indicators that respond to a shared triggering event in a manner such that different time period indicators visually correlate with their respective time intervals. Thus, the approximate time that transpires may be observed. For instance, a plurality of time period indicators (i.e.,  92   a,    92   b,    92   c,    92   d,    92   e,    92   f,    92   g,  and  92   h ) correlate to the time transpired, preferably in a visually indicative manner. 
         [0023]    By tracking the time periods described above, sample collection time, centrifugation-ready time, and sample integrity time may be measured or monitored. For instance, knowledge of clot time in a serum chemistry tube may be determined when, for example, the thirty minute mark is reached by label  90 A, indicating that sufficient time has transpired for the sample to clot long enough prior to centrifugation which is desired or required in certain testing protocols. For a plasma chemistry tube, knowledge of time that the sample has been sitting in a container prior to centrifugation may facilitate ensuring that the sample is centrifuged within the allowable period for a specific diagnostic assay, such as a period of two hours from the drawing of the sample which is desired or required in certain protocols. In addition, with such a label, assessing whether a rack (or some other grouping or collection) of tubes meets certain time constraints is facilitated and the need to handle each individual tube may be obviated. 
         [0024]    In accordance with another embodiment of the invention, label  90 A may be triggered at a time subsequent to drawing a sample into container  20 . For example, label cover  80  may be lifted immediately before centrifugation or after centrifugation, so that the time of centrifugation or post-centrifugation processes may be measured. Alternatively, label  90 A may be triggered at a time subsequent to drawing a sample into container  20  by the application of a label cover  80  to all or a portion of the surface of label  90 A. 
         [0025]    In accordance with another embodiment of the invention, collection system  10  further includes a characteristic labeling system, which in accordance with an embodiment of the invention, comprises characteristic label  90   a  and label cover  80 . In accordance with an embodiment of the invention, characteristic label  90   a  is configured to track the amount of time that has transpired upon direct or indirect adherence (i.e., peeling) of characteristic label  90   a  to a portion of one or both of sample collection tube  20  or closure  16 . Sample collection tube  20  or closure  16  may have a surface capable of transmitting an activator matrix to a portion of characteristic label  90   a,  wherein characteristic label  90   a  comprises an indicator matrix responsive to the activator matrix. 
         [0026]    Characteristic label  90   a  may therefore, in accordance with an embodiment of the invention, use visually changing paper (“VCP”) technology that is triggered by a triggering event, such as when the characteristic label  90 A is adhered to one or both of sample collection tube  20  or closure  16 . The triggering event causes the VCP technology to transition from an inactivated state to an activated state. 
         [0027]    In  FIG. 2 , characteristic label  90   b  is illustrated. Similar to label  90   a,  characteristic label  90   a  identifies time that transpires upon exposure of such label. Characteristic  90   a,  however, also includes temperature read-out  95 . In one embodiment, such read-out is effectuated by polymerization of monomers and may utilize, at least in part, the Arrhenius relationship. While read-out  95  is illustrated as a number, such read-out may be displayed in the form of a color which corresponds to a temperature range, limit, or combinations thereof. 
         [0028]    In one embodiment, label  90   a  monitors the maximum temperature to which the label  90 B (and therefore the container to which label  90   b  is affixed) is exposed—regardless of whether the label is exposed to light or temperature. In another embodiment, label  90   b  is configured to measure temperature once the label is exposed to light and/or air. 
         [0029]    As shown in  FIGS. 3   a  and  3   b  with respect to collection tube  60   a  and  60   b,  one or more of the following features may be included: time and temperature shelf life indicator  30 , fill range  40  and hemolysis indicator  50 . 
         [0030]    Time and temperature shelf life indicator  30  may be situated on tube  60   a  and may be effectuated by polymerization of monomers utilizing, at least in part, the Arrhenius relationship. With such indicator  30 , a user may easily observe whether a container has “expired” prior to drawing a sample, testing the sample, or some other point in the sample collection and testing process resulting in fewer redraws or unnecessary or inaccurate testing. 
         [0031]    In addition, in accordance with an embodiment of the invention, mix indicator (not shown) may be provided on tube  20  to ensure that the appropriate number of mixes and amount of mixing time is performed. Adequate mixing improves sample integrity, quality, and reliability. In an embodiment of the invention, an accelerometer may be integrated with the tube  20  such that motion representative of mixing may be identified, recorded, and outputted. The output may be in a form that is visually apparent to the user or optionally may be discreet such that the output may be interrogated by a device remote from the tube (i.e., a reading from a hand-held scanner). 
         [0032]    In accordance with another embodiment of the invention, a label is applied to a portion of tube  20 , wherein the backside  22   a  of label  22  or the surface affixed or is fixable to the outside wall surface of tube  20  includes fill range indicator  40 . Such indicator  40  may comprise some form of pre-printed marking or shape specific marking, such as a black solid indicator portion or a cut, cutout, or visible perforation portion. The color, shading, pattern, and shape of such portions may vary as long as each is recognizable by the user. In an embodiment of the invention, indicator  40  comprises a low fill indicator  40   a,  situated at the bottom boundary of indicator  40  and a high fill indicator  40   b,  situated at the upper boundary of indicator  40 . In other embodiments, one of either a low fill indicator  40   a  or high fill indicator  40   b  may be utilized. The low fill indicator  40   a  and the high fill indicator  40   b  set the lower and upper limits for drawing a sample from a sample source (i.e. Patient&#39;s venous blood), such that sufficient sample amounts are collected to effectuate certain tests and to effectuate adequate reagent to sample mixing ratios and proper centrifugation considerations or conditions. In another embodiment of the invention, the word “fill” or some other word indicative of the indicator&#39;s purpose may be displayed in the indicator area. High fill, low fill, and generic fill indicators may comprise boundaries of each limit, or optionally may include a filled or empty space area correlating to a desired fill range. For certain tubes, the desired fill range may correlate to the quantity of reagents or additives deployed into the tube prior to use or at the point of manufacture to ensure proper sample to additive ration. In embodiments disclosed in the present application, the fill indicators ( 40   a  and/or  40   b ) are preferably disposed on that portion of label  22  such that a user may interpret the level or quantity of sample collected from the patient into the container, by looking through a portion of the generally clear sidewall of tube  20 . 
         [0033]    In accordance with another embodiment of the invention, label  22  comprises on a backside  22   a  information pertaining to at least one of a manufacture catalog number, identifiable bar code, shelf life, lot identification number, or container specific identifier of tube  20 , wherein the backside is adhered to the sidewall of tube  20 . In accordance with another embodiment of the invention, the label  22  further comprises on its other side (opposite of  22   a ) information specific to a sample intended to be placed or already placed into the container of which the label  22  is adhered to and/or information specific to a patient in a hospital. 
         [0034]    In accordance with another embodiment of the invention, label  22  comprises on a first side, a fill indication correlating to the proper draw fill volume for a first tube, wherein the backside  22   a  of label  22  or the surface affixed or ad fixable to the outside wall surface of tube  20  includes fill range indicator  40 . Such indicator  40  may comprise some form of pre-printed marking or shape specific marking, such as a black solid indicator portion or a cut, cutout, or visible perforation portion. The color, shading, pattern, and shape of such portions may vary, as long as each are recognizable by the user. In an embodiment of the invention, indicator  40  comprises a low fill indicator  40   a  situated at the bottom boundary of indicator  40  and a high fill indicator  40   b  situated at the upper boundary of indicator  40 . 
         [0035]    In accordance with another embodiment of the invention, label  22  includes hemolysis color indicator  50 , possibly in the form of a chart or scale. The indicator  50  may be displayed on the tube facing side, the side opposite the tube facing side, or optionally both. Additionally, the hemolysis color indicator  50  may be printed directly onto a tube  20  rather than on a label applicable to a tube  20 . One method for measuring levels of hemolysis, i.e., the breaking of the cell membranes of red blood cells, is visually identifying the color of all or a portion of a blood sample. For example, in many instances, the shade of the serum that resides above the hematocrit for a blood sample is indicative of general qualitative hemolysis levels, such as zero, trace (or slight), moderate, and gross (or severe). Such indication may be displayed by including a color scale on blood containment device having different hemolysis level terminologies associated with and printed on the hemolysis scale. Some examples of scales/terminologies that can be included to convey for measuring levels of hemolysis are: a 0, +1, +2, and +3 scale; a 0, 1+, 2+, and 3+ scale; 0, 1, 2, and 3 scale; a 0, +, ++, and +++ scale; or a zero, trace, +, ++, and +++ scale. The color scale for indicating hemolysis ranges from a light yellow to a dark reddish orange. A Pantome color scheme may be chosen to represent variances between the low and high color indicators. Other indications of hemolysis levels may be provided. 
         [0036]    Included on the label  22  or directly printed onto a tube  20 , in accordance with an embodiment of the invention, is a barcode or some other machine readable data that is unique to each container, either unique to all container, or optionally unique to a subset of all containers produced. Such information may also be used for storage of additional data associated with container, such as container manufacturer information, container type, intended draw size information, and the like. In addition, patient-specific, test-specific, or other application-specific information may be stored (i.e., electronically) and associated with the container&#39;s unique identifier. In accordance with another embodiment of the invention, the machine readable information may be provided on a container&#39;s permanent label, container&#39;s removable label, the container itself, or some combination thereof. Such design may allow for less information to be provided by users of the tube and/or fewer labels to be manually affixed by users. 
         [0037]    Another manner for providing information associated with a biological sample container is to affix, embed or otherwise associate a radio frequency identification (RFID) tag with such container. Such a feature also allows for unique identification of the container, in accordance with an embodiment of the invention. Such RFID tags may be passive in nature with an electronic device having some type of reading/scanning mechanism to receive identification information off the tag. In another embodiment, the tag is active in nature in which an electronic device is used to receive a signal generated by or from the tag. In accordance with an embodiment of the invention, the tags may be writeable, readable, or both. With such a system, the need for more conventional type labeling having machine readable or human readable information may be complemented or obviated. 
         [0038]    While the present invention is satisfied by embodiments in many different forms, there is shown in the figures and described herein in detail, various embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other embodiments will be apparent to, and readily made by those skilled in the art, without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents.