Patent Description:
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.

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.

Additionally, identifying other characteristics and/or information 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, e.g., mixing, or whether the appropriate amount of sample has been collected may be significant.

In <CIT> a dual-sided two-ply direct thermal image element is provided. In one embodiment of <CIT>, the dual-sided two-ply direct thermal image element comprises a first substrate having a first side and a second side, and a second substrate having a first side and a second side, wherein both the first substrate and the second substrate include a thermally sensitive coating on at least a first side thereof, and wherein the second side of the first substrate is releasably attached to the second side of the second substrate.

<CIT> describes 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 another embodiment of the <CIT>, 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. In yet another embodiment of the <CIT>, 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.

<CIT> describes a piggyback label construction includes a first label having a stock ply with a bottom face having pressure sensitive adhesive, and an imagable top face. In <CIT>, a second label comprises a stock ply having a bottom face with pressure sensitive adhesive, a top face with a continuous image-producing coating, and a continuous adhesive release coating over the image-producing coating. The image-producing coating in <CIT> preferably is a thermosensitive coating having a first heat activation temperature of about <NUM> DEG -<NUM> DEG F. (preferably about <NUM> DEG -<NUM> DEG F). In <CIT>, the first label stock ply has a weight of about <NUM> lbs. per <NUM> sheet <NUM>"x17" ream, or less (preferably about <NUM>-<NUM> lbs. In <CIT>, the first label stock imagable top face preferably is a second thermosensitive coating having a higher heat activation temperature than the first heat activation temperature. The image-producing coating of <CIT> may comprise a self-contained coating. The first label of <CIT> may be offset from the second label to provide an exposed portion of the second label image-producing portion which is separated from the rest of the construction by a perforation line, and having pre-printed non-variable indicia.

Further background art for the present invention is described in <CIT> and <CIT>.

The present disclosure provides a biological sample containment system and a label for a container that includes a first layer having a first readable information portion and a second layer removably attached to the first layer, the second layer having a second readable information portion. The first layer and the second layer of the label are both formed of a thermosensitive material. The first readable information portion is identical to the second readable information portion. The label of the present disclosure allows a portion of the label having readable information to be removed and adhered to a patient record, for example, while a portion of the label having identical readable information remains on the container.

The label for a container includes a first layer having a first readable information portion and formed of a thermosensitive material; and a second layer removably attached to the first layer, the second layer having a second readable information portion and formed of a thermosensitive material.

The first readable information portion is identical to the second readable information portion. In another configuration, at least a part of the first readable information portion is a first barcode and at least a part of the second readable information portion is a second barcode, the second barcode identical to the first barcode. The label includes a securement portion on a surface of the first layer. The securement portion comprises an adhesive on a rear surface of the first layer. In another configuration, at least a part of the first readable information portion and at least a part of the second readable information portion comprise electronically readable information. The label includes a release layer disposed between the first layer and the second layer. In one configuration, the label includes a fill line indicator. In another configuration, a portion of the first layer includes the fill line indicator. In yet another configuration, a portion of the second layer includes the fill line indicator. In one configuration, the first layer and the second layer are formed of the same thermosensitive material.

The biological sample containment system includes a container for collecting a biological sample and a label for the container including a first layer having a first readable information portion and formed of a thermosensitive material and a second layer removably attached to the first layer, the second layer having a second readable information portion and formed of a thermosensitive material. The label for the container of the biological sample containment system corresponds to a label as defined above.

The first readable information portion is identical to the second readable information portion. In another configuration, at least a part of the first readable information portion is a first barcode and at least a part of the second readable information portion is a second barcode, the second barcode identical to the first barcode. In yet another configuration, the biological sample containment system includes a securement portion on a surface of the first layer. In one configuration, the securement portion comprises an adhesive on a rear surface of the first layer. In another configuration, at least a part of the first readable information portion and at least a part of the second readable information portion comprise electronically readable information. In yet another configuration, the biological sample containment system includes a release layer disposed between the first layer and the second layer. In one configuration, the label further comprises a fill line indicator. In another configuration, a portion of the first layer includes the fill line indicator. In yet another configuration, a portion of the second layer includes the fill line indicator. In one configuration, the first layer and the second layer are formed of the same thermosensitive material. In yet another configuration, the container is a biological specimen collection container. In one configuration, the container is a blood collection tube.

In accordance with another example, a method of providing information on a container includes providing a label comprising a first layer formed of a thermosensitive material and a second layer removably attached to the first layer and formed of a thermosensitive material; providing a container; adhering the label to the container; and imparting a first readable information portion in the first layer and a second readable information portion in the second layer.

In one configuration, the method includes simultaneously imparting the first readable information portion in the first layer and the second readable information portion in the second layer. In another configuration, at least a part of the first readable information portion is identical to at least a part of the second readable information portion. In yet another configuration, at least a part of the first readable information portion is a first barcode and at least a part of the second readable information portion is a second barcode, the second barcode identical to the first barcode. In one configuration, the method includes forming a securement portion on a surface of the first layer. In another configuration, the method includes forming the securement portion on a rear surface of the first layer. In yet another configuration, the securement portion comprises an adhesive. In one configuration, at least a part of the first readable information portion and at least a part of the second readable information portion comprise electronically readable information. In another configuration, the method includes forming a fill line indicator on the label. In yet another configuration, the method includes forming the fill line indicator on a portion of the first layer. In one configuration, the method includes forming the fill line indicator on a portion of the second layer. In another configuration, the first layer and the second layer are formed of the same thermosensitive material.

Corresponding reference characters indicate corresponding parts throughout the several views.

However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention.

<FIG> illustrate an exemplary embodiment of the present disclosure. Referring to <FIG>, a biological sample containment system <NUM> of the present disclosure includes a biological specimen collection container <NUM> for collecting a biological sample and a labeling system or label <NUM> for the container <NUM>. In one embodiment, the label <NUM> includes a first layer <NUM> having a first readable information portion <NUM> and a second layer <NUM> removably attached to the first layer <NUM>, the second layer <NUM> having a second readable information portion <NUM>. The first layer <NUM> and the second layer <NUM> of the label <NUM> are both formed of a thermosensitive material. The first layer <NUM> and the second layer <NUM> are formed of a thermo-sensitive material. The first readable information portion <NUM> is identical to the second readable information portion <NUM>. The label <NUM> of the present disclosure allows a portion of the label <NUM> having readable information to be removed and adhered, such as by an adhesive on the label <NUM>, to a patient record, for example, while a portion of the label <NUM> having identical readable information remains on the container <NUM>.

Referring to <FIG>-<NUM>, a biological specimen collection container <NUM> for collecting a biological sample of the present disclosure is illustrated. In one embodiment, the container <NUM> comprises a specimen collection tube <NUM> and a closure <NUM>. The specimen collection tube <NUM> may comprise any sample collection tubes or containers. For example, the specimen collection tube <NUM> may comprise a blood collection tube, a chemistry sample tube, a coagulation sample tube, a hematology sample tube, or other sample tube. In one embodiment, the tube <NUM> 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 other embodiments, the biological specimen collection container <NUM> may comprise a vessel of a different shape, i.e., other than a cylindrical shape, and, in some instances, may not be a tube. For example, the biological specimen collection container <NUM> may comprise a collection cup, bag, or other container. In one embodiment, the closure <NUM> may be made of a resealable elastomeric polymer and additionally may comprise a polymer cap integral to the resealable elastomeric polymer.

The biological specimen collection container <NUM> may include an open top end <NUM>, a closed bottom end <NUM>, and a sidewall <NUM> extending therebetween, defining a container interior <NUM> adapted to receive a biological specimen, such as blood, therein. The closure <NUM> may cover the open top end <NUM> of the specimen collection container <NUM>. In some embodiments, the specimen collection container <NUM> may be a single walled container formed of glass and/or a polymeric composition. In other embodiments, the specimen collection container <NUM> may include a tube-in-tube configuration in which a second specimen collection container is disposed within the container interior <NUM>.

Referring to <FIG>, the biological sample containment system <NUM> of the present disclosure includes a labeling system or label <NUM> for the container <NUM>. In one embodiment, the label <NUM> includes a first layer <NUM> having a first readable information portion <NUM> and a second layer <NUM> removably attached to the first layer <NUM>, the second layer <NUM> having a second readable information portion <NUM>. The first readable information portion <NUM> is identical to the second readable information portion <NUM>. The label <NUM> of the present disclosure allows a portion of the label <NUM> having readable information to be removed and adhered to a patient record, for example, while a portion of the label <NUM> having identical readable information remains on the container <NUM>. The label <NUM> includes an additional identifying information portion <NUM> that has a front surface <NUM> and a rear surface <NUM>. The first layer <NUM> includes a rear surface <NUM> and a front surface <NUM>. The second layer <NUM> includes a rear surface <NUM> and a front surface <NUM>. In one embodiment, the second layer <NUM> includes a flap <NUM> for easy gripping to facilitate removal of the second layer <NUM> from the first layer <NUM>.

Referring to <FIG>, the label <NUM> that can be applied to a container <NUM> includes multiple layers. For example, the label <NUM> includes a first layer <NUM>, a second layer <NUM>, a release layer <NUM>, a securement portion <NUM>, and a label backing <NUM>.

The release layer <NUM> is disposed between the first layer <NUM> and the second layer <NUM>. In this manner, the second layer <NUM> is removably attached to the first layer <NUM> such that the second layer <NUM> can be pulled off the first layer <NUM> and adhered to an item such as a patient record. The release layer <NUM> comprises a weaker adhesive that allows the second layer <NUM> to be removably attached to the first layer <NUM>.

The label <NUM> includes a securement portion <NUM> on a surface of the first layer <NUM>. For example, the securement portion <NUM> may be located on a rear surface <NUM> of the first layer <NUM>. The securement portion <NUM> comprises a stronger adhesive layer or adhesive <NUM> that allows the label <NUM> to be securely attached to a container <NUM>. The label <NUM> also includes a label backing <NUM> disposed behind the securement portion <NUM> to cover and protect the securement portion <NUM> until it is desired to adhere the label <NUM> to a container <NUM>. Before applying the label <NUM>, the label backing <NUM> is removed and the securement portion <NUM> is adhered to a container <NUM>.

The first layer <NUM> and the second layer <NUM> of the label <NUM> are both formed of a thermosensitive material. The thermosensitive material may comprise any suitable material which allows for an image or indicia to be formed thereon or therein in response to an applied increase of temperature, such as, for example, a barcode burned therein. The first layer <NUM> and the second layer <NUM> are formed of the same thermosensitive material.

The label <NUM> includes a first layer <NUM> having a first readable information portion <NUM> and a second layer <NUM> removably attached to the first layer <NUM>, the second layer <NUM> having a second readable information portion <NUM>. In one embodiment, at least a part of the first readable information portion <NUM> is identical to at least a part of the second readable information portion <NUM>. The label <NUM> of the present disclosure allows a portion of the label <NUM> having readable information to be removed and adhered to a patient record, for example, while a portion of the label <NUM> having identical readable information remains on the container <NUM>.

The first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include any information identifying characteristics of the sample and/or container that may be useful to the healthcare practitioner. For example, the information may identify the integrity of the sample, whether the sample has been subjected to appropriate procedures, or whether the appropriate amount of sample has been collected.

Furthermore, the information may relate to maximum temperatures that the container and/or sample may be exposed to, the timeframe that the container and/or sample may be used upon manufacture, shipment, or some other event, or the amount of time that has transpired after collection of the sample into the container.

For example, the first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include fill range indicators, low fill indicators, high fill indicators, hemolysis indicators, time indicators, temperature indicators, or other information identifying characteristics of the sample and/or container that may be useful to the healthcare practitioner.

In one embodiment, at least a part of the first readable information portion <NUM> is a first barcode <NUM> and at least a part of the second readable information portion <NUM> is a second barcode <NUM>. In one embodiment, the second barcode <NUM> may be identical to the first barcode <NUM>. In one embodiment, at least a part of the first readable information portion <NUM> and at least a part of the second readable information portion <NUM> comprise electronically readable information.

For example, in one embodiment, included on a portion of the label <NUM> is a barcode or some other machine readable data that is unique to each container or optionally unique to a subset of containers. Such information may also be used for storage of additional data associated with a 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, e.g., electronically, and associated with the container's unique identifier.

The first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include a radio frequency identification (RFID) tag which provides information associated with a container. An RFID tag allows for unique identification of the container. 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.

The first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include information relating to monitoring the maximum temperature to which the label <NUM> and the container <NUM> are exposed. In another embodiment, the label <NUM> may include information relating to measuring the temperature once the label <NUM> and the container <NUM> are exposed to light and/or air.

The first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include information relating to a time and temperature shelf life indicator that allows a user to 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.

Referring to <FIG>, the first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include information relating to a mix indicator <NUM> that ensures that the appropriate number of mixes and amount of mixing time is performed. Adequate mixing improves sample integrity, quality, and reliability. In one embodiment, an accelerometer may be integrated with the container <NUM> 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.

Referring to <FIG>, the first readable information portion <NUM> and/or the second readable information portion <NUM> of the label <NUM> may include information relating to a hemolysis indicator, possibly in the form of a chart or scale. 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 a 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 <NUM>, +<NUM>, +<NUM>, and +<NUM> scale; a <NUM>, <NUM>+, <NUM>+, and <NUM>+ scale; a <NUM>, <NUM>, <NUM>, and <NUM> scale; a <NUM>, +, ++, 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.

Referring to <FIG>, <FIG>, the label <NUM> includes an additional identifying information portion <NUM> that has a front surface <NUM> and a rear surface <NUM>. The first layer <NUM> includes a rear surface <NUM> and a front surface <NUM>. The second layer <NUM> includes a rear surface <NUM> and a front surface <NUM>. Referring to <FIG>, in one embodiment, the rear surface <NUM> of the additional identifying information portion <NUM> and/or the rear surface <NUM> of the first layer <NUM> includes a first information area <NUM>, a second information area <NUM>, a third information area <NUM>, a fourth information area <NUM>, and a fifth information area <NUM>. The information areas may include any of the identifying information described above. In other embodiments, the rear surface <NUM> of the additional identifying information portion <NUM> and/or the rear surface <NUM> of the first layer <NUM> may include any orientation and/or number of information areas configured to provide any of the identifying information described above.

In one embodiment, the rear surface <NUM> of the additional identifying information portion <NUM> and/or the rear surface <NUM> of the first layer <NUM> may include information pertaining to at least one of a manufacture catalog number, identifiable bar code, shelf life, lot identification number, container specific identifier, information specific to a sample intended to be placed or already placed into the container, and/or information specific to a patient in a hospital.

<FIG> illustrate another exemplary embodiment. The embodiment illustrated in <FIG> includes similar components to the embodiment illustrated in <FIG>, <FIG>, and the similar components are denoted by a reference number followed by the letter A. For the sake of brevity, these similar components and the similar steps of using a biological sample containment system 10A (<FIG>) will not all be discussed in conjunction with the embodiment illustrated in <FIG>.

Referring to <FIG>, the biological sample containment system 10A includes a label 20A for a container 12A that includes a fill line indicator <NUM>. In one embodiment, the fill line indicator <NUM> 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 one embodiment, the fill line indicator <NUM> includes a low fill indicator situated at the bottom boundary of the fill line indicator <NUM> and a high fill indicator situated at the upper boundary of the fill line indicator <NUM>. In other embodiments, one of either a low fill indicator or high fill indicator may be utilized. The low fill indicator and the high fill indicator set the lower and upper limits for drawing a sample from a sample source, e.g., a patient'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, the word "fill" or some other word indicative of the indicator'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 containers, the desired fill range may correlate to the quantity of reagents or additives deployed into the container prior to use or at the point of manufacture to ensure proper sample to additive ration. The fill line indicators may be disposed on a portion of the label <NUM> 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 the container <NUM>.

In one embodiment, a portion of the first layer 22A includes the fill line indicator <NUM>. For example, referring to <FIG>, the first layer 22A includes a notch <NUM> that can be used as the fill line indicator <NUM>.

In one embodiment, a portion of the second layer 26A includes the fill line indicator <NUM>. For example, referring to <FIG>, the second layer 26A includes a band <NUM> that can be used as the fill line indicator <NUM>.

<FIG> illustrates another exemplary embodiment. The embodiment illustrated in <FIG> also includes similar components to the embodiment illustrated in <FIG>, <FIG>, and the similar components are denoted by a reference number followed by the letter B. For the sake of brevity, these similar components and the similar steps of using a biological sample containment system 10B (<FIG>) will not all be discussed in conjunction with the embodiment illustrated in <FIG>.

Referring to <FIG>, the biological sample containment system 10B includes grooves <NUM> disposed in a label 20B or a container 12B and a reading needle <NUM>. In such an embodiment, information may be obtained using the reading needle <NUM> which can be disposed within the grooves <NUM> while the container 12B is rotated as shown in <FIG>.

Referring to <FIG>, as described above, the label <NUM> of the present disclosure allows a second layer <NUM> of the label <NUM> having readable information <NUM> to be removed and adhered to a patient record <NUM>, for example, while a first layer <NUM> of the label <NUM> having identical readable information <NUM> remains on the container <NUM>.

<FIG> illustrates other exemplary embodiments. The embodiment illustrated in <FIG> includes similar components to the embodiment illustrated in <FIG>, <FIG>, and the similar components are denoted by a reference number followed by the letters C and D. For the sake of brevity, these similar components and the similar steps of using a biological sample containment system 10C (<FIG>) and a biological sample containment system 10D (<FIG>) will not all be discussed in conjunction with the embodiment illustrated in <FIG>.

Referring to <FIG>, the biological sample containment system 10C includes a label 20C for a container 12C that includes a tear away portion <NUM>. In such an embodiment, the tear away portion <NUM> may be removed so that a fill line indicator or clear portion <NUM> is exposed.

Referring to <FIG>, the biological sample containment system 10D includes a label 20D for a container 12D that includes an invisible bar code label <NUM> on a rear surface 48D of the label 20D. In such an embodiment, a camera recognition system may be used with the invisible bar code label <NUM> to read and utilize information.

Referring to <FIG>, a method of providing information on a container will now be described. The method includes providing a label <NUM> having a first layer <NUM> formed of a thermosensitive material and a second layer <NUM> removably attached to the first layer <NUM> and formed of a thermosensitive material; providing a container <NUM>; adhering the label <NUM> to the container <NUM>; and imparting a first readable information portion <NUM> in the first layer <NUM> and a second readable information portion <NUM> in the second layer <NUM>. The method includes simultaneously imparting the first readable information portion <NUM> in the first layer <NUM> and the second readable information portion <NUM> in the second layer <NUM>.

Claim 1:
A label (<NUM>) for a container, the label comprising:
a first layer (<NUM>) having a first readable information portion (<NUM>);
an adhesive layer (<NUM>) located on a back surface of the first layer and a release layer (<NUM>) located on a front surface of the first layer, said front surface being an opposite surface from the back surface, said adhesive layer capable of securely adhering the label to a container; and
a second layer (<NUM>) having a back surface superimposed on and removably secured to a portion of the release layer (<NUM>) and a portion of the first layer, wherein the release layer comprises an adhesive capable of removably securing the second layer (<NUM>) to the first layer (<NUM>), the second layer having a second readable information portion (<NUM>),
said label (<NUM>) characterized in that
the first layer (<NUM>) is formed of a thermosensitive material capable of having first readable information burned therein, and the second layer (<NUM>) is formed of a thermosensitive material capable of having second readable information burned therein, wherein the first layer and the second layer are formed from the same material, wherein the first and second readable information is simultaneously burned into the first and second layers, wherein said second readable information is identical to the first readable information burned therein, and wherein the release layer (<NUM>) enables the second layer (<NUM>) to be removed from the first layer (<NUM>).