CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No.

61/778,910 filed March 13, 2013, which is incorporated herein by reference in its entirety.

TECHNOLOGY FIELD

[0002] The present invention relates generally to handling and controlling specimens in sample tubes and vials, and more particularly to a septum, or barrier, for protecting a specimen in a sample tube or vial.

BACKGROUND

[0003] Barrier devices, or septa, may be used to protect the contents contained in sample tubes in in vitro diagnostics (IVD) environments. The septa help mitigate evaporation, while also acting as a barrier to reduce contamination. To access the contents contained in the sample tubes by, for example, a probe or other tool, the septa need to either be removed or otherwise manipulated to provide access to the contents. Removing the septa is not typically a desirable option: the removal (and later replacement) of the septa includes an additional step to be completed by a human or a complex machine, which also adds extra time and expenses to be incurred; physically removing the septa may result in accidental spills of the contents of the sample tubes; and the septa have to be safely and conveniently displaced while the probes or other tools are accessing the contents.

[0004] Some septa are passive devices that allow for a probe or other tool to pass through a portion of the septa to gain access to the contents contained in the sample tubes. This may be accomplished by an opening in the septa that is pushed apart by the probe or other tool. A problem with this type of passive device is cross-contamination. A probe, when being removed from the sample tube, rubs against the opening and leaves residual contents on the septa; then the next probe will pass through the same opening and be in contact with the residual contents from the first probe. This is repeated, and multiplied, for each probe that needs access to a particular sample tube.

[0005] This document describes exemplary septa that can be utilized in IVD environments to provide a barrier to sample tubes when not in use and to provide access to contents contained in the sample tubes without causing residual materials to be transferred between the septa and a probe or tool accessing the sample tube contents.

SUMMARY

[0006] Embodiments of the present invention provide a septum for providing a barrier for a specimen in a sample tube to mitigate evaporation and contamination.

[0007] According to an embodiment, an exemplary septum includes a cover configured to removably attach to a sample tube, the cover comprising a top wall for covering a top portion of the sample tube and a side wall for engaging side portions of the sample tube. At least one bi-metallic strip is movably fitted within a portion of the top wall of the cover, with each bi-metallic strip having a secured end portion and a moveable end portion. The at least one bi-metallic strip is configured to stay flush with the top wall of the cover in a reduced temperature environment, and bend at the moveable end portion away from the top wall of the cover to create an opening in the top wall of the cover in a raised temperature environment.

[0008] In one embodiment, the septum has two or more bi-metallic strips oriented so as to extend lengthwise from respective secured end portions at respective outer edge portions of the top wall of the cover and join in an area of the top wall of the cover where the moveable end portions meet one another. In an embodiment, the moveable end portions are in close proximity with each other. In another embodiment, the moveable end portions touch one another. In yet another embodiment, one or more of the moveable end portions overlap one or more of the other moveable end portions.

[0009] In one embodiment, the geometry of the moveable end portions of the two or more bi-metallic strips are a function of the number and position of the two or more bimetallic strips to provide for the two or more bi-metallic strips to meet and form a seemingly continuous moveable closure in the top wall of the cover.

[0010] In one embodiment, the septum has two bi-metallic strips oriented so as to extend lengthwise from opposing respective secured end portions at respective outer edge portions of the top wall of the cover and join in a middle area of the top wall of the cover where the moveable end portions meet one another.

[0011] In an embodiment, the portion of the top wall of the cover in which the at least one bi-metallic strip is movably fitted overlays outer edges of the at least one bi-metallic strip.

[0012] In an embodiment, the at least one bi-metallic strip is comprised of two metals that expand at different rates when heated, the two metals being joined together lengthwise. In an embodiment, the two metals are steel and brass, or steel and copper.

[0013] In an embodiment, the reduced temperature environment comprises a refrigerated environment. In another embodiment, the reduced temperature environment comprises room temperature.

[0014] In an embodiment, the raised temperature environment comprises a room temperature environment. In another embodiment, the raised temperature environment comprises a heated environment.

[0015] In another embodiment of the present invention, a septum for providing a barrier for a specimen in a sample tube includes a cover that is configured to removably attach to the sample tube, the cover comprising a top wall for covering a top portion of the sample tube and a side wall for engaging side portions of the sample tube. The septum further includes at least one strip movably fitted within a portion of the top wall of the cover, wherein the at least one strip comprises a secured end portion and a moveable end portion, the at least one strip configured to move between a closed position, in which the at least one strip is flush with the top wall of the cover, and an open position, in which the at least one strip bends at the moveable end portion away from the top wall of the cover to create an opening in the top wall of the cover. The bending of the at least one strip from the closed position to the open position forms an opening that is contact- free from a probe configured to access the specimen in the sample tube.

[0016] According to an embodiment, the at least one strip comprises at least one bimetallic strip, which is in the closed position in a reduced temperature environment and moves to the open position upon application of heat.

[0017] In another embodiment, the at least one strip comprises at least one single strip, wherein the at least one single strip moves from the closed position to the open position upon application of an electrical charge.

[0018] Other embodiments of the present invention are directed to a system for use in an in vitro diagnostics (IVD) environment including a sample tube configured to contain therein a specimen, a septum to engage and cover the sample tube, and a probe configured to access the specimen by passing through an opening created in the septum. The septum includes a cover configured to removably attach to the sample tube, the cover comprising a top wall for covering a top portion of the sample tube and a side wall for engaging side portions of the sample tube; and at least one strip movably fitted within a portion of the top wall of the cover, the at least one strip having a secured end portion and a moveable end portion, where the at least one strip is configured to move between a closed position, in which the at least one strip is flush with the top wall of the cover, and an open position, in which the at least one strip bends at the moveable end portion away from the top wall of the cover to create an opening in the top wall of the cover. The bending of the at least one strip forms an opening that is contact-free from the probe accessing the specimen in the sample tube.

[0019] In an embodiment, the system further includes a refrigeration unit configured to store the sample tube with the septum attached thereto in a reduced temperature environment. In this embodiment, the at least one strip is at least one bi-metallic strip, the at least one bi-metallic strip being in the closed position in a reduced temperature environment and moving to the open position in a raised temperature environment. In other embodiments, the system may include a heating unit configured to raise the temperature of the septum to a raised temperature environment.

[0020] In another embodiment, the system includes a source to provide an electrical charge to the at least one strip. In this embodiment, the at least one strip is at least one single strip, the at least one single strip moving from the closed position to the open position upon application of the electrical charge. In other embodiments, the septum includes two or more single strips that respond to the electrical charge.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The foregoing and other aspects of the present invention are best understood from the following detailed description when read in connection with the accompanying drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments that are presently preferred, it being understood, however, that the invention is not limited to the specific instrumentalities disclosed. Included in the drawings are the following Figures:

[0022] FIG. 1 A is a top view of an exemplary septum, according to an embodiment;

[0023] FIG. IB is a top view of an exemplary septum, according to an additional embodiment; [0024] FIG. 1C is a perspective view of an exemplary septum, according to an embodiment;

[0025] FIG. ID is a top view of an exemplary septum, according to another embodiment;

[0026] FIG. IE is a top view of an exemplary septum, according to yet another embodiment;

[0027] FIG. 2 A is a cross-sectional view of an exemplary septum in a reduced temperature environment, according to an embodiment;

[0028] FIG. 2B is a cross-sectional view of an exemplary septum in a raised temperature environment, according to an embodiment;

[0029] FIG. 2C is a cross-sectional view of an exemplary septum in a reduced temperature environment, according to another embodiment;

[0030] FIG. 3A is a cross-sectional view of an additional exemplary septum in a reduced temperature environment, according to an embodiment;

[0031] FIG. 3B is a cross-sectional view of an additional exemplary septum in a raised temperature environment, according to an embodiment;

0032] FIG. 4 shows an exemplary septum being utilized with a probe in a sample tube, according to an embodiment; and

[0033] FIG. 5 is a system diagram illustrating an example in vitro diagnostics (IVD) environment where a sample tube containing an exemplary septa is being aspirated, according to an embodiment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0034] Embodiments of the present invention relate to providing a barrier for a sample tube to protect the contents of the sample tube from, for example, evaporation and contamination, while at the same time providing non-contact access to the contents. [0035] Embodiments of the present invention are particularly well suited for, but in no way limited to, an in vitro diagnostics (IVD) environment in which specimens contained in sample tubes need to be carefully handled to reduce or eliminate evaporation and contamination, while at the same time need to be easily accessed for various testing. The exemplary septa described herein achieve the desired objectives by incorporating one or more strips in a cover for a sample tube, where in conditions in which the specimen is being stored and not accessed, the one or more strips remain closed; and in conditions in which the specimen is needed to be accessible, the one or more strips move to provide access therein.

[0036] FIGs. 1A through IE depict an exemplary septum 100, with a top view provided in FIGs. 1A, IB, ID, and IE; and a perspective view provided in FIG. 1C. The septum 100 is comprised of a cover 110 with a top wall 112 and a side wall 114. The cover 110 is configured to removably attach to a sample tube, with the top wall 112 covering a top portion of the sample tube and the side wall 114 engaging side portions of the sample tube (see FIG. 4). The cover 110 may be, according to an embodiment, a cap, such as a screw top cap or a friction fit cap or the like, that covers and protects the contents (e.g., a specimen) contained within a sample tube. The cover 110 may be a rubber or plastic material. The septum 100 includes at least one bi-metallic strip 120 that is moveably fitted within a portion of the top wall 112 of the cover 110.

[0037] The exemplary septum 100 shown in FIGS. 1A and IB includes one bimetallic strip 120, although the septum 100 is not so limited and may include two bi-metallic strips 120a and 120b (see FIGs. 1C and ID) , three bi-metallic strips 120c, 120d, and 120e (see FIG. IE), or more bi-metallic strips. Each bi-metallic strip 120 has a secured end portion 122 and a moveable end portion 124. The secured end portion 122 may be securably attached at or near an outer edge of the top wall 112 of the cover 110, while the moveable end portion 124 is not secured to any portion of the top wall 112 of the cover 110, allowing the moveable end portion 124 to move to create an opening in the top wall 112 as further described below. The secure end portion 122 may be molded within the top wall 112 or otherwise secured therein.

[0038] According to the embodiment in which the septum 100 includes one bimetallic strip 120, as shown in FIGs. 1A and IB, the one bi-metallic strip 120 may extend across a central or near central portion of the top wall 112. In the embodiment illustrated in FIG. 1 A, the bi-metallic strip 120 extends across the length of the top wall 112 of the cover 110; while in the embodiment illustrated in FIG. IB, the bi-metallic strip 120 extends across a portion of the length of the top wall 112 of the cover 110. As described in further detail below, the bi-metallic strip 120 bends to create an opening in the top wall 112 of the cover. In some embodiments, it is desirable for the opening to be near a central portion of the top wall 112. The embodiment in which the bi-metallic strip 120 extends across a portion of the length of the top wall 112 may be preferable as the bi-metallic strip 120 does not need to bend as great a distance to create an opening in a central portion of the top wall 112.

[0039] The exemplary septum 100 shown in FIGS. 1C and ID includes two bimetallic strips 120a and 120b, with secured end portions 122a, 122b and moveable end portions 124a, 124b. In this embodiment, the two bi-metallic strips 120a, 120b are oriented so as to extend lengthwise from the secured end portions 122a, 122b at opposing respective outer edge portions of the top wall 112 and join at or near a middle area of the top wall 112 of the cover 110 where the two moveable end portions 124a, 124b meet. In a preferred embodiment, as shown in FIGS. 1C and ID, the two strips 120a, 120b are fitted within a central area of the top wall 112 of the cover and the two strips 120a, 120b are oriented 180 degrees from one another; however, the septum 100 is not so limited to this configuration. For example, according to an embodiment, one of the two strips 120a, 120b may be of a longer length than the other of the two strips 120a, 120b, so that the two moveable end portions 124a, 124b do not meet in the middle of the top wall 112. Moreover, the strips 120a, 120b need not extend across a middle portion of the top wall 112 but may instead extend across other portions of the top wall 112. Additionally, the strips 120a, 120b need not extend from opposing edges of the top wall 112 to form a straight continuous strip but may instead meet at angles with respect to one another.

[0040] In an embodiment in which the septum 100 includes three bi-metallic strips

120c, 120d, and 120e (see FIG. IE), the strips 120c, 120d, and 120e may be equally spaced apart (e.g., 120c is 120 degrees from each of the other two strips 120d and 120e) to meet in a central area of the top wall 112 of the cover 110. The strips 120c, 120d, and 120e may, in other embodiments, be spaced apart from one another by other amounts. Moreover, the strips 120c, 120d, and 120e may be of various lengths, with one strip of strips 120c, 120d, and 120e longer than the other two, for example. The three bi-metallic strips 120c, 120d, and 120e have respective secured end portions 122c, 122d, and 122e and moveable end portions 124c, 124d, and 124e.

[0041] In other embodiments, the septum 100 may include four or more bi-metallic strips.

[0042] The geometry of the moveable end portions 124 of the bi-metallic strips 120 may be a function of the number and position of the bi-metallic strips 120 to provide for the bi-metallic strips 120 to meet together and form a seemingly continuous moveable closure in the top wall 112 of the cover 110. For example, if the septum 100 includes three bi-metallic strips 120c, 120d, and 120e (as shown in FIG. IE), the moveable end portions 124c, 124d, and 124e may be triangular; if the septum includes one bi-metallic strip 120 (as shown in FIGs. 1A and IB), the moveable end portions 124 may be rectangular.

[0043] Rather than the moveable end portions 124a and 124b meeting end to end or in close proximity to one another, according to an additional embodiment, one moveable end portion 124a of the bi-metallic strips 120a may overlap the moveable end portion 124b of the bi-metallic strip 120b (see FIG. 2C). This configuration is not limited to the two bi-metallic strip 120a, 120b embodiment, but may also be implemented with three or more bi-metallic strips.

[0044] According to an additional embodiment, the portion of the top wall 112 of the cover 110 in which the bi-metallic strips 120 are movably fitted may overlay outer edges of the bi-metallic strips 120. As such, the bi-metallic strips 120 may be sunken in with respect to the top wall 112 of the cover 110 (see, for example, FIGs. 2A, 2B, and 2C). In other embodiments, the bi-metallic strips 120 may form a continuous portion of the top wall 1 12 of the cover (see, for example, FIG. 1C).

[0045] Now turning to operation of the septum 100, the at least one bi-metallic strip

120 is configured to stay flush with the top wall 112 of the cover 110 in a reduced- temperature environment and bend at the moveable end portion 124 away from the top wall 112 of the cover 110 to create an opening in the top wall 112 of the cover 110 upon application of heat or in a raised-temperature environment. This movement is achieved by each of the bi-metallic strips 120 being comprised of two metals, joined together lengthwise, that expand at different rates when heated. The different expansion rates cause the bimetallic strip 120 to bend in one direction when heated and in an opposite direction when cooled. According to an embodiment, in a reduced temperature environment, the at least one bi-metallic strip 120 maintains a flat position, causing the at least one bi-metallic strip 120 to stay flush and form a seal with the top wall 112. In a raised temperature environment, the at least one bi-metallic strip 120 bends away from the top wall 112 of the cover 110, creating an opening in the top wall 112. In one embodiment, the at least one bi-metallic strip 120 bends downward away from the top wall 112, while in another embodiment, the at least one bimetallic strip 120 bends upward away from the top wall 112. The reduced temperature environment may be a refrigerated environment, according to an embodiment. In another embodiment, the reduced temperature environment may be a room temperature environment. The raised temperature environment may be at or near room temperature, according to one embodiment. In another embodiment, the raised temperature environment may be a heated environment. The raised temperature environment may be approximately 20-30°C above the reduced temperature environment, according to an embodiment.

[0046] FIG. 2A provides a cross-sectional view of the exemplary septum 100 in a reduced temperature environment, according to an embodiment. In this embodiment, two bimetallic strips 120a, 120b are in a closed position with respect to the top wall 112 of the cover 110. In practice, a sample tube with the exemplary septum 100 may be refrigerated, and the closed position of the bi-metallic strips 120a, 120b reduces evaporation and contamination effects on the specimen contained within the sample tube.

[0047] FIG. 2B provides a cross-sectional view of the exemplary septum 100 in a raised temperature environment, according to an embodiment. In this embodiment, two bimetallic strips 120a, 120b are in an open position with respect to the top wall 112 of the cover 110 to form opening 130. In practice, a sample tube with the exemplary septum 100 may be in a room temperature environment, and the increase in temperature from the reduced temperature environment to the raised temperature environment naturally causes the two bimetallic strips 120a, 120b to bend, creating the opening 130 in the top wall 112 of the cover 110.

[0048] FIG. 2C provides a cross-sectional view of the exemplary septum 100 in a reduced temperature environment, according to an additional embodiment. In this embodiment, two bi-metallic strips 120a, 120b are in a closed position with respect to the top wall 112 of the cover 110, and bi-metallic strip 120a slightly overlaps bi-metallic strip 120b. [0049] According to an additional embodiment, with reference to FIGs. 3A and 3B, another exemplary septum 300 may include, fitted within a top wall 312 of a cover 310, two single strips 320a, 320b that are activated to open and close through applying electrical potential or current to the one or more single strips 320a, 320b through electrical leads 326a, 326b. In an embodiment, the two single strips 320a, 320b comprise a memory metal, and current is applied to the one or more single strips 320a, 320b, causing the one or more single strips 320a, 320b to bend and thereby create an opening 330 in the top wall 312 of the cover 310. While this embodiment requires a source and contact with the septum 300 through the electrical leads 326a, 326b, accessing the specimen is still provided in a contact-free manner (i.e., a probe does not come into contact with the septum).

[0050] FIGs. 3A and 3B depict the exemplary septum 300, with a cross-sectional view of the septum 300 closed provided in FIG. 3A and a cross-sectional view of the septum 300 opened in FIG. 3B. The septum 300 is comprised of a cover 310, including a top wall 312 and a side wall 314, configured to removably attach to a sample tube (such as sample tube 420 in FIG. 4), with the top wall 312 covering a top portion of the sample tube and the side wall 314 engaging side portions of the sample tube. The cover 310 may be, according to an embodiment, a rubber or plastic cap, such as a screw top cap or a friction fit cap or the like, that covers and protects the specimen contained within a sample tube.

[0051] The exemplary septum 300 shown in FIGS. 3A and 3B includes two single strips 320a, 320b, although the septum 300 is not so limited and may include one single strip 320 or multiple single strips 320. Each single strip 320a, 320b has a secured end portion 322a, 322b and a moveable end portion 324a, 324b. The secured end portions 322a, 322b are securably attached at or near an outer edge of the top wall 312 of the cover 310, while the moveable end portions 324a, 324b are not secured to any portion of the top wall 312 of the cover 310, allowing the moveable end portion 324a, 324b to move to create an opening in the top wall 312 as described above.

[0052] Various configurations of the one or more single strips 320 of the septum 300 may be analogous to those described above with respect to the one or more bi-metallic strips 120 of the septum 100. For example, in an embodiment including two single strips 320a, 320b, the strips 320a, 320b, may be oriented so as to extend lengthwise from the secured end portions at opposing respective outer edge portions of the top wall 312 and join at or near a middle area of the top wall 312 of the cover 310 where the two moveable end portions meet.

[0053] According to another embodiment, one of the two strips 320a, 320b may be of a longer length than the other of the two strips 320a, 320b, so that the two moveable end portions do not meet in the middle of the top wall 312. In another embodiment, the strips 320a, 320b need not extend across a middle portion of the top wall 312 but may instead extend across other portions of the top wall 312. Additionally, the strips 320a, 320b need not extend from opposing edges of the top wall 312 to form a straight strip but may instead meet at other angles with respect to one another.

[0054] The geometry of the single strips 320 may be a function of the number and position of the single strips 320 to provide for the single strips 320 to meet together and form a seemingly continuous moveable closure in the top wall 312 of the cover 310. Rather than the moveable end portions meeting end to end, according to an embodiment, one or more moveable end portions of one or more single strips 320 may overlap another one or more moveable end portions (similar to the bi-metallic strip embodiment shown in FIG. 2C) . Also, according to an additional embodiment, the portion of the top wall 312 of the cover 310 in which the single strips 320 are movably fitted may overlay outer edges of the single strips 320. Or, according to another embodiment, the single strips 320 may be fitted within the top wall 312 of the cover 310 to form a continuous top portion comprised of the top wall 312 and the single strips 320.

[0055] FIG. 4 shows the exemplary septum 100 or 300 being utilized with a probe

410 in a sample tube 420, according to an embodiment. In this embodiment, the septum 100, 300 covering the sample tube 420 is in a raised temperature environment, which provides for the bi-metallic strips 120 or the single strips 320 to bend and create an opening 230, 330 in the top wall 112 or 312. The probe 410 is therefore able to access the specimen 430 contained within the sample tube 420 without contacting the septum 100, 300; thus, neither the probe 410 nor the septum 100, 300 transfer residual materials onto one another.

[0056] FIG. 5 is a system diagram illustrating an example in vitro diagnostics (IVD) environment 500 where a sample tube 420 containing an exemplary septum 100, 300 can be aspirated, according to an embodiment.

[0057] The IVD environment 500 may include a cold storage environment 510 configured to store the sample tube 420 with the septum 100, 300 attached thereto in the reduced temperature environment. The IVD environment 500 may also include a sample entry point 520 where the sample tube 420 with the septum 100, 300 is placed prior to being aspirated.

[0058] In the case in which the exemplary septum 100 with one or more bi-metallic strips 120 is being utilized, a heating unit 525 may be provided in the sample entry point 520 to raise the temperature of the sample tube 420 with the septum 100 to allow for the at least one bi-metallic strip 120 to bend away from the top wall 112 to create the opening in the top wall 112 of the cover 110. The heating unit 525 may be employed when it is desirable to quickly raise the temperature of the septum 100 to allow for the bi-metallic strips 120 to move to create the opening therein. Alternately, the sample tube 420 may be kept in the sample entry point 520 to naturally warm up to room temperature, causing the septum 100 to open as it approaches system operating temperature. Once the septum 100 is opened, the sample tube 420 is routed along a sample travel path 530 to a sample aspiration point 540 at an analyzer 550 for aspiration. Once the aspiration has been performed, the sample tube 420 is returned to the cold storage environment 510 for storage, where the septum 100 will naturally close as it is cooled.

[0059] In a scenario in which the exemplary septum 300 with one or more single strips 320 is being utilized, an electrical potential or current source may be provided at the sample aspiration position 540 to provide an electrical potential or current to the one or more single strips 320 to cause the one or more single strips 320 to bend, creating an opening in the top wall 312 of the cover 310. Once the aspiration has been performed, the electrical potential or current source is removed, causing the septum 300 to close. The sample tube 420 with the septum 300 may be returned to the cold storage environment 510, with the septum 300 in a closed position to mitigate evaporation and contamination.

[0060] Although the present invention has been described with reference to exemplary embodiments, it is not limited thereto. Those skilled in the art will appreciate that numerous changes and modifications may be made to the preferred embodiments of the invention and that such changes and modifications may be made without departing from the true spirit of the invention. It is therefore intended that the appended claims be construed to cover all such equivalent variations as fall within the true spirit and scope of the invention.