Specimen collection container assembly

Abstract

A specimen collection container includes inner and outer tubes. The inner tube includes a bottom end, a top end, and a sidewall extending therebetween defining an interior. The sidewall includes an inner surface and an outer surface having at least one annular protrusion extending therefrom. The inner tube includes at least one funnel portion adjacent the top end for directing a specimen into the inner tube interior, and an annular ring disposed about a portion of the outer surface of the sidewall adjacent the top end. The outer tube includes a bottom end, a top end, and a sidewall extending therebetween, the sidewall having an outer surface and an inner surface defining an annular recess adapted to receive a portion of the annular protrusion therein. The inner tube is disposed within the outer tube and a portion of the top end of the outer tube abuts the annular ring.

Claims

1. A specimen collection container comprising: an inner tube having a closed bottom end, a top end, and a sidewall extending therebetween defining an inner tube interior, said sidewall having an inner surface including at least one angled directing surface extending toward the closed bottom end, the inner tube comprising at least one funnel portion adjacent the top end, said funnel portion including at least one introducing surface having a curvature configured for directing a specimen down the funnel and into the inner tube interior, said angled surface and said at least one introducing surface together forming a combined gradually angled surface; and an outer tube comprising a bottom end, a top end including an upper end, and a sidewall extending therebetween, wherein the inner tube is disposed at least partially within the outer tube such that the at least one funnel portion sits above the upper end of the outer tube, wherein the inner tube and the outer tube are press-fit together within the same forming process or are in-molded, wherein the inner tube and outer tube are molded and assembled in the same press, wherein a portion of the sidewall of the inner tube including at least a portion of the angled surface comprises an exterior stabilizer extending along the sidewall of the inner tube in a longitudinal direction, the exterior stabilizer being configured to contact a portion of an inner surface of the sidewall of the outer tube, the angled surface of the inner tube being angled relative to the exterior stabilizing surface and wherein the sidewall of the inner tube is tapered from the at least one angled surface to the closed bottom end to increase a column height of the specimen disposed within the interior of the inner tube.

2. The specimen collection container of claim 1, wherein the sidewall of the inner tube is configured to cooperate with the sidewall of the outer tube to secure the inner tube within the outer tube.

3. The specimen collection container of claim 1, wherein the sidewall of the inner tube includes an annular ring extending outwardly therefrom and the at least one funnel portion is located adjacent to and above the annular ring and wherein a portion of the upper end of the outer tube abuts the annular ring.

4. The specimen collection container of claim 1, wherein the top end of the inner tube comprises a second funnel portion, such that the second funnel portion is substantially opposite the at least one funnel portion.

5. The specimen collection container of claim 1, wherein at least one of the sidewall of the inner tube and the sidewall of the outer tube includes at least one fill-line for allowing a clinician to determine the volume of specimen within the inner tube.

6. The specimen collection container of claim 1, wherein the inner tube completely seals the top end of the outer tube.

7. The specimen collection container of claim 1, further comprising a specimen collection cap sealing at least one of the top end of the inner tube and the top end of the outer tube.

8. The specimen collection container of claim 1, wherein an overall length of the container is a length that is compatible with standard industry specifications for automated clinical processes.

9. The specimen collection container of claim 8, wherein the overall length of the container is between 75 mm and 100 mm.

10. The specimen collection container of claim 1, wherein an outer surface of the exterior stabilizer includes an inwardly tapered portion extending away from and out of contact with the inner surface of the sidewall of the outer tube.

11. The specimen collection container of claim 1, wherein the at least one angled directing surface extends toward the closed bottom end and is configured for directing an instrument toward the closed bottom end.

12. A specimen collection container comprising: an inner tube having a closed bottom end, a top end, and a sidewall extending therebetween defining an inner tube interior, said sidewall having an inner surface including at least one angled directing surface extending toward the closed bottom end, the inner tube comprising at least one funnel portion adjacent the top end, said funnel portion including at least one introducing surface having a curvature configured for directing a specimen down the funnel and into the inner tube interior, said angled surface and said at least one introducing surface together forming a combined gradually angled surface; and an outer tube comprising a bottom end, a top end including an upper end, and a sidewall extending therebetween, wherein the inner tube is disposed at least partially within the outer tube such that the at least one funnel portion sits above the upper end of the outer tube, wherein the inner tube and the outer tube are press-fit together, wherein a portion of the sidewall of the inner tube including at least a portion of the angled surface comprises an exterior stabilizer extending along the sidewall of the inner tube in a longitudinal direction, the exterior stabilizer being configured to contact a portion of an inner surface of the sidewall of the outer tube, the angled surface of the inner tube being angled relative to the exterior stabilizing surface and wherein the sidewall of the inner tube is tapered from the at least one angled surface to the closed bottom end to increase a column height of the specimen disposed within the interior of the inner tube, wherein the bottom end of the outer tube comprises at least one vent for venting air from the space defined between the inner tube and the outer tube.

13. A specimen collection container comprising: an inner tube having a closed bottom end, a top end, and a sidewall extending therebetween defining an inner tube interior, said sidewall having an inner surface including at least one angled directing surface extending toward the closed bottom end, the inner tube comprising at least one funnel portion adjacent the top end, said funnel portion including at least one introducing surface having a curvature configured for directing a specimen down the funnel and into the inner tube interior, said angled surface and said at least one introducing surface together forming a combined gradually angled surface, said top end of said inner tube having a receiving portion diameter D1 and an annular ring having an outer diameter D2 that is greater than D1, said at least one funnel portion being located adjacent to and extending above the annular ring; and an outer tube comprising a bottom end, a top end, and a sidewall extending therebetween defining an outer tube interior having an inner diameter D3 which is greater than D1 and less than D2 and wherein the inner tube is disposed at least partially within the outer tube, wherein the inner tube and the outer tube are press-fit together within the same forming process or are in-molded, wherein the inner tube and outer tube are molded and assembled in the same press, wherein a portion of the sidewall of the inner tube including at least a portion of the angled surface comprises an exterior stabilizer extending along the sidewall of the inner tube in a longitudinal direction, the exterior stabilizer being configured to contact a portion of an inner surface of the sidewall of the outer tube, the angled surface of the inner tube being angled relative to the exterior stabilizing surface, and wherein the sidewall of the inner tube is tapered from the at least one angled surface to the closed bottom end to increase a column height of the specimen disposed within the interior of the inner tube.

14. The specimen collection container of claim 13, wherein the inner tube has an overall length L2, the outer tube has an overall length L3 which is greater than L2, and wherein assembly of the inner tube within the outer tube results in the specimen collection container having an overall length L5 which is greater than L3.

15. The specimen collection container of claim 13, wherein an outer surface of the exterior stabilizer includes an inwardly tapered portion extending away from and out of contact with the inner surface of the sidewall of the outer tube.

16. The specimen collection container of claim 13, wherein the at least one angled directing surface extends toward the closed bottom end and is configured for directing an instrument toward the closed bottom end.

17. A specimen collection container comprising: an inner tube having a closed bottom end, a top end, and a sidewall extending therebetween defining an inner tube interior, said sidewall having an inner surface including at least one angled directing surface extending toward the closed bottom end, the inner tube comprising at least one funnel portion adjacent the top end, said funnel portion including at least one introducing surface having a curvature configured for directing a specimen down the funnel and into the inner tube interior; and an outer tube comprising a bottom end, a top end including an upper end, and a sidewall extending therebetween, wherein the inner tube is disposed at least partially within the outer tube such that the at least one funnel portion sits above the upper end of the outer tube, wherein the bottom end of the outer tube comprises at least one vent for venting air from the space defined between the inner tube and the outer tube.

18. The specimen collection container of claim 17, wherein said angled surface and said at least one introducing surface together form a combined gradually angled surface.

19. The specimen collection container of claim 18, wherein a portion of the sidewall of the inner tube including at least a portion of the angled surface comprises an exterior stabilizer extending along the sidewall of the inner tube in a longitudinal direction, the exterior stabilizer being configured to contact a portion of an inner surface of the sidewall of the outer tube, the angled surface of the inner tube being angled relative to the exterior stabilizing surface and wherein the sidewall of the inner tube is tapered from the at least one angled surface to the closed bottom end to increase a column height of the specimen disposed within the interior of the inner tube.

20. The specimen collection container of claim 17, wherein the inner tube and the outer tube are press-fit together.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a frontwardly directed perspective view of a specimen collection container assembly in accordance with an embodiment of the present invention.

(2) FIG. 2 is a perspective view of the cap of the specimen collection container assembly shown in FIG. 1 in accordance with an embodiment of the present invention.

(3) FIG. 3 is a cross-sectional view of the cap shown in FIG. 2 taken along line 3-3 in accordance with an embodiment of the present invention.

(4) FIG. 4 is a front view of the inner tube having a funnel of the specimen collection container shown in FIG. 1 in accordance with an embodiment of the present invention.

(5) FIG. 5 is a front view of an alternative inner tube having dual funnels of the specimen collection container shown in FIG. 1 in accordance with an embodiment of the present invention.

(6) FIG. 6 is a front view of the outer tube of the specimen collection container shown in FIG. 1 in accordance with an embodiment of the present invention.

(7) FIG. 7 is a front view of an alternative outer tube having an annular protrusion of the specimen collection container shown in FIG. 1 in accordance with an embodiment of the present invention.

(8) FIG. 8 is a cross-sectional side view of the specimen collection container assembly shown in FIG. 1 taken along line 8-8 in accordance with an embodiment of the present invention.

(9) FIG. 9 is a close-up cross-sectional view of the cap shown in FIG. 8 taken along segment 9 in accordance with an embodiment of the present invention.

(10) FIG. 10 is a frontwardly directed perspective view of an alternative embodiment of a specimen collection container assembly in accordance with an embodiment of the present invention.

(11) FIG. 11 is a perspective view of the cap of the specimen collection container assembly shown in FIG. 10 in accordance with an embodiment of the present invention.

(12) FIG. 12 is a cross-sectional view of the cap shown in FIG. 11 taken along line 12-12 in accordance with an embodiment of the present invention.

(13) FIG. 13 is a cross-sectional side view of the specimen collection container assembly shown in FIG. 10 taken along line 13-13 in accordance with an embodiment of the present invention.

(14) FIG. 14 is a close-up cross-sectional view of the cap shown in FIG. 13 taken along segment 14 in accordance with an embodiment of the present invention.

(15) FIG. 15 is a frontwardly directed perspective view of an alternative embodiment of a specimen collection container assembly in accordance with an embodiment of the present invention.

(16) FIG. 16 is a cross-sectional side view of the specimen collection container assembly shown in FIG. 15 taken along line 16-16 in accordance with an embodiment of the present invention.

(17) FIG. 17 is a close-up cross-sectional view of the cap shown in FIG. 16 taken along segment 17 in accordance with an embodiment of the present invention.

(18) FIG. 18 is a frontwardly directed perspective view of an alternative embodiment of a specimen collection container assembly in accordance with an embodiment of the present invention.

(19) FIG. 19 is a perspective view of the cap of the specimen collection container assembly shown in FIG. 18 in accordance with an embodiment of the present invention.

(20) FIG. 20 is a cross-sectional view of the cap shown in FIG. 19 taken along line 20-20 in accordance with an embodiment of the present invention.

(21) FIG. 21 is a cross-sectional side view of the specimen collection container assembly shown in FIG. 18 taken along line 21-21 in accordance with an embodiment of the present invention.

(22) FIG. 22 is a close-up cross-sectional view of the cap shown in FIG. 21 taken along segment 22 in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

(23) As shown in FIG. 1, a specimen collection container assembly 30, such as a biological fluid collection container, includes an inner tube 32, an outer tube 34, and a specimen cap 86. The inner tube 32, as shown in FIGS. 4-5, is used for the collection and containment of a specimen, such as capillary blood or other bodily fluid, for subsequent testing procedures and diagnostic analysis. The outer tube 34, as shown in FIGS. 6-7, acts primarily as a carrier for the inner tube 32, providing additional protection for the contents of the inner tube 32 as well as providing external dimensions that are compatible with standard automated clinical laboratory processes, such as Clinical Laboratory Automation. The specimen cap 86, as shown in FIGS. 2-3, provides a means for a user to access the inner tube 32 to obtain the specimen deposited therein, and also provides a leak proof seal with the inner tube 32 upon replacement of the specimen cap 86, as will be discussed herein.

(24) Referring specifically to FIGS. 4-5, the inner tube 32 includes an open top end 38, a closed bottom end 40, and a sidewall 42 extending therebetween defining an inner tube interior 44 adapted to receive a specimen therein. Referring to FIG. 4, the open top end 38 may include at least one funnel 46 or scoop portion for facilitating and directing a specimen into the interior 44 of the inner tube 32. The funnel 46 includes at least one introducing surface 48 having a curvature for guiding a specimen down the funnel 46 and into the interior 44 of the inner tube 32. In use, the funnel 46 may be placed adjacent a specimen and used to scoop the specimen into the inner tube 32. In certain instances the funnel 46 may be placed adjacent a patient's fingertip, and the funnel 46 may be used to scoop capillary blood into the inner tube 32.

(25) Referring to FIG. 5, in other configurations, the open top end 38 of the inner tube 32 may include dual funnels 46A, 46B. The dual funnels 46A, 46B may be offset, such that the curvature of the introducing surface 48A of the first funnel 46A faces the corresponding curvature of the introducing surface 48B of the second funnel 46B, thereby forming a finger receiving surface 50. In use, a patient's finger tip may be placed in contact with the finger receiving surface 50 for directing capillary blood into the interior 44 of the inner tube 32.

(26) The inner tube 32 may also include an annular ring 52 disposed about a portion of the sidewall 42. In certain configurations, the annular ring 52 is disposed adjacent the open top end 38 and extends outwardly from an exterior surface 54 of the sidewall 42. The inner tube 32 may further include an annular protrusion 68 extending outwardly from the exterior surface 54 of the sidewall 42. In another embodiment, the annular protrusion 68 may extend inwardly into an interior of the inner tube 32. In certain configurations, the annular protrusion 68 may be positioned below the annular ring 52.

(27) The open top end 38 of the inner tube 32 may be adapted to provide a sufficiently wide opening to allow standard diagnostic and sampling probes, needles, and/or similar extraction or deposition devices to enter the open top end 38 and access the interior 44 for the purpose of depositing a specimen therein or withdrawing a specimen therefrom. In one embodiment, the interior 44 of the inner tube 32 may include at least one angled directing surface 58 for directing a standard instrument probe or other device toward the closed bottom end 40 of the inner tube 32. In certain configurations it is desirable for both the introducing surface 48 of the funnel 46 and the angled directing surface 58 to be smooth and gradual surfaces to promote the flow of specimen into the interior 44 of the inner tube 32.

(28) In one embodiment, the dimensions of the inner tube 32 are balanced such that the open top end has an opening having a sufficient width W, as shown in FIG. 4, to allow a standard instrument probe to pass therethrough, and also to have an inner tube diameter D sufficient to provide the greatest column height of a specimen disposed within the interior 44 of the inner tube 32.

(29) During a sampling procedure, an increased specimen column height within the inner tube 32, provides for a greater volume of specimen that may be retrieved or extracted by an analyzer probe (not shown).

(30) At least one stabilizer 56 may be provided on the exterior surface 54 of the sidewall 42. The stabilizer 56, as shown in FIGS. 4-5, may have any suitable shape such that an outer surface 59 contacts at least a portion of the outer tube 34, as shown in FIGS. 6-7. Referring to FIGS. 6-7, the outer tube 34 has an open top end 60, a closed bottom end 62, and a sidewall 64 extending therebetween and forming an outer tube interior 66. The sidewall 64 of the outer tube 34 includes an inner surface 72 and an outer surface 74 and may include at least one recess 70 extending into a portion of the sidewall 64, such as into the inner surface 72 of a portion of the sidewall 64 adjacent the open top end 60. The recess 70 is adapted to receive at least a portion of the annular protrusion 68 of the inner tube 32 therein during assembly.

(31) Referring to FIG. 7, the outer surface 74 may also include an annular ring 76 extending outwardly from the outer surface 74 of the sidewall 64 adjacent the open top end 60. In certain configurations, the annular ring 76 is positioned below the recess 70 along the sidewall 64.

(32) Referring again to FIGS. 6-7, the outer tube 34 is dimensioned to receive the inner tube, as shown in FIGS. 4-5 at least partially therein, as shown in FIGS. 8-9. In one embodiment, the outer tube 34 has sufficient inner dimensions to accommodate the inner tube 32 therein. During assembly, the inner tube 32 may be at least partially positioned within the outer tube 34 such that an upper end 78 of the outer tube 34 abuts the annular ring 52 of the inner tube 32 allowing for a receiving portion of the inner tube having a length L, shown in FIG. 4, to be received within the outer tube interior 66, as shown in FIG. 8. Referring specifically to FIG. 4, the receiving portion of the inner tube 32 has a diameter D.sub.1 that is dimensioned for receipt within the outer tube interior 66 and is smaller than the inner diameter D.sub.3 of the outer tube 34, as shown in FIG. 6. The annular ring 52 of the inner tube 32 is dimensioned to restrain any further portion of the inner tube 32 from passing within the outer tube 34 and has a diameter D.sub.2, shown in FIG. 4, that is greater than the inner diameter D.sub.3 of the outer tube 34. As described above, during assembly the recess 70 of the outer tube 34 is adapted to receive at least a portion of the annular protrusion 68 of the inner tube 32 therein, as shown in FIGS. 8-9.

(33) Although the inner tube 32 and the outer tube 34 may have any suitable dimensions, the inner tube may have an overall length L.sub.2 of about 48 mm, as shown in FIG. 5, and have an inner tube diameter D of about 7 mm, as shown in FIG. 4. The outer tube 34 may have any suitable dimensions that are compatible with standard industry specifications for automated clinical processes, such as having an overall length L.sub.3 of about 69 mm, as shown in FIG. 6, and an outer diameter D.sub.4 of about 13 mm. The outer tube 34 may also be dimensioned to accommodate standard size labels applied to the outer surface 74 and may be dimensioned to improve manipulation by a clinician. This can be particularly advantageous when collecting small volume samples of specimen. A clinician can manipulate the outer tube 34, which is significantly easier to hold, while collecting a small volume specimen within the inner tube 32 disposed within the outer tube 34. When the inner tube 32 and the outer tube 34 are assembled, the overall length L.sub.5 may be the industry standard length of 75 mm, as shown in FIG. 8, or an industry standard length of 100 mm.

(34) In one embodiment, the inner tube 32 and the outer tube 34 may be in-molded in which both the inner tube 32 and the outer tube 34 are molded in the same press and assembled, as opposed to being separately molded and subsequently assembled. Alternatively, the inner tube 32 and the outer tube 34 may be press-fit within the same forming process. By forming both the inner tube 32 and the outer tube 34 together, the tolerances of the relative engagement between the inner tube 32 and the outer tube 34 may be improved because the relative rate of shrink is the same for both tubes. In certain configurations, the inner tube 32 and the outer tube 34 may be formed of the same material, such as polypropylene and/or polyethylene. In other configurations, the inner tube 32 and the outer tube 34 may be formed of two different polymeric materials. In certain embodiments it is noted that an assembly having an inner tube 32 and an outer tube 34 having thin walls allows for optical clarity of the sample when viewed by an automated vision system, assisting in sample and quality detection. In addition, increased optical clarity may assist a medical practitioner during collection of a specimen.

(35) During assembly and/or formation of the inner tube 32 and the outer tube 34, air may become trapped between the inner surface 72 of the outer tube 34 and the exterior surface 54 of the sidewall 42 of the inner tube 32. Accordingly, the bottom end 62 of the outer tube 34 may include a vent 80, as shown in FIG. 7, for allowing air trapped between the inner surface of the outer tube 34 and the exterior surface 54 of the sidewall 42 of the inner tube 32 to escape therethrough. In certain configurations, the vent 80 may also assist in the molding process of the inner tube 32 by locking the core pin of the mold during the molding process to prevent relative shifting between the outer tube 34 and the formation of the inner tube 32.

(36) In one embodiment of the present invention, at least one of the inner tube 32 and the outer tube 34 include at least one fill-line 82, shown in FIGS. 4-5, for allowing a clinician to determine the volume of specimen within the inner tube 32. In another embodiment, at least one of the inner tube 32 and the outer tube 34 includes a colored or light blocking additive 84, as shown in FIG. 8. The additive may allow sufficient light to pass through the sidewall 42 of the inner tube 32 to allow a clinician to visualize the contents of the interior 44 of the inner tube 32, and to also prevent enough light from passing through the sidewall 42 of the inner tube 32 to compromise or otherwise alter the contents of the inner tube 32. This application is particularly useful for specimens collected for light sensitive analytes, such as Bilirubin, as light degrades the specimen quality required for this testing procedure. In one embodiment, the additive may be sprayed, coated, or in-molded with at least one of the inner tube 32 and the outer tube 34. In another embodiment, the additive is intended to block only certain wavelengths of light from passing through the sidewall 42 of the inner tube 32.

(37) Referring to FIGS. 2-3, a specimen collection cap 86 is provided for sealing the open top end 38 of the inner tube 32 and/or the open top end 60 of the outer tube 34. In one embodiment, once the inner tube 32 and the outer tube 34 are assembled, the open top end 60 of the outer tube 34 is sealed by the open top end 38 of the inner tube 32, specifically by the annular ring 52 of the inner tube 32. Accordingly, in this configuration the specimen collection cap 86 may only seal the open top end 38 of the inner tube 32 but effectively seals the open top end 60 of the outer tube 34 as well. The specimen collection cap 86 includes a top surface 88 and an annular shoulder 90 depending therefrom. The specimen collection cap 86 may also include an annular interior wall 92 depending from the top surface 88, with the annular shoulder 90 circumferentially disposed about the annular interior wall 92 and spaced therefrom by a tube receiving portion 94.

(38) In one embodiment, an elastomeric stopper or pierceable septum 96 may be disposed at least partially within the annular interior wall 92 and extending therebetween forming a sealing body within the specimen collection cap 86. In one embodiment, the pierceable septum 96 is formed from a thermoplastic elastomer (TPE). The pierceable septum 96 may be pierced by a needle cannula or probe, as is conventionally known, and may be self-sealing. The pierceable septum 96 may be formed through an offset flow channel 98, as is described in United States Patent Publication No. 2009/0308184, the entire disclosure of which is hereby incorporated by reference. The pierceable septum 96 may include a concave receiving surface 100 adjacent the top surface 88 for directing an instrument, such as a needle cannula or a probe, to the apex 102 of the concave receiving surface 100. This allows a clinician to more easily determine proper placement of the needle cannula or probe for puncturing the pierceable septum 96. An opening 104 within the top surface 88 of the specimen collection cap 86 may also be dimensioned to accommodate standard clinical probes and needle cannulae for both hematology and chemistry analysis therethrough. The pierceable septum 96 also includes a specimen directing surface 106 for funneling a specimen into an apex 108 of the specimen collection cap 86 when the specimen collection container assembly 30, shown in FIG. 1, is inverted for specimen withdrawal, as is described in United States Patent Publication No. 2009/0308184.

(39) Referring again to FIG. 3, the annular interior wall 92 may have an inner surface 110 contacting the pierceable septum 96. A portion of the inner surface 110 of the annular interior wall 92 may include a septum restraining portion 112 for preventing the inadvertent advancement of the pierceable septum 96 through the specimen collection cap 86 when pressure is applied to the pierceable septum 96 by a needle cannula or probe. The septum restraining portion 112 extends at least partially into the pierceable septum 96 for creating a physical restraint therebetween.

(40) The annular shoulder 90 of the specimen collection cap 86 has an inner surface 114 having a first protrusion 116 extending from the inner surface 114 into the tube receiving portion 94, and a second protrusion 118 extending from the inner surface 114 into the tube receiving portion 94. The first protrusion 116 is spaced apart from the second protrusion 118, such as laterally offset therefrom along a portion of the inner surface 114 of the annular shoulder 90. The first protrusion 116 and the second protrusion 118 may extend annularly into the tube receiving portion 94.

(41) As shown in FIGS. 8-9, when the specimen collection cap 86 and the inner tube 32 and outer tube 34 are combined, the annular shoulder 90 is positioned over the exterior surface 54 of the sidewall 42 of the inner tube 32 and the outer surface 74 of the sidewall 64 of the outer tube 34. The pierceable septum 96 contacts and forms a barrier seal 122 with a portion of the interior 44 of the inner tube 32, thereby sealing the interior 44 from the external atmosphere. The funnel 46, and portions of the open top end 38 of the inner tube 32 and the portions of the open top end 60 of the outer tube 34 are received within the tube receiving portion 94. The first protrusion 116 and the second protrusion 118 form a first recess 120 therebetween for accommodating the annular ring 52 of the inner tube 32 therein, thereby forming a first seal 124 between the specimen collection cap 86 and the inner tube 32.

(42) Referring again to FIG. 3, the specimen collection cap 86 may also include a third protrusion 126 extending from the inner surface 114 of the annular shoulder 90 into the tube receiving portion 94. The third protrusion 126 may extend annularly into the tube receiving portion 94 and may be provided adjacent a bottom end 128 of the annular shoulder 90. Referring again to FIG. 9, when the specimen collection cap 86, inner tube 32, and outer tube 34 are combined, the third protrusion 126 may engage a portion of the outer surface 74 of the sidewall 64 of the outer tube 34 forming a second seal 130.

(43) The barrier seal 122 formed between the pierceable septum 96 and the interior 44 of the inner tube 32 maintains the interior 44 in a sterile condition prior to receipt of a specimen therein. The barrier seal 122 also maintains the condition of the specimen present within the inner tube 32 after recapping or re-sealing of the pierceable septum 96. The first seal 124 and the second seal 130 form a tortuous path between the external atmosphere and the barrier seal 122 further enhancing the overall sealing system of the specimen collection container assembly 30, shown in FIG. 1. In addition, the first seal 124 and the second seal 130 maintain the funnel 46 in a sterile condition prior to use.

(44) Optionally, as shown in FIGS. 1-2, the annular shoulder 90 of the specimen collection cap 86 may include a plurality of ribs 132 extending along a portion of an exterior surface 134 of the annular shoulder 90. These ribs 132 may be used to help identify the intended contents of the inner tube 32, additives and/or amounts of additives present within the inner tube 32, and/or the intended testing procedure to be performed on the contents of the inner tube 32.

(45) With reference to FIGS. 10-14, an alternative specimen collection cap 86A is shown. The specimen collection cap 86A is adapted for use with the inner tube 32 and/or the outer tube 34 as described herein, and is substantially similar to the specimen collection cap 86, with several alternatives. Specifically, a sealing band 138 is disposed annularly about an interior surface 114A of an annular shoulder 90A and extends into a tube receiving portion 94A. The sealing band 138 forms a hermetic seal 136 with a portion of the outer surface 74 of the outer tube 34. In one embodiment, the sealing band 138 is deformable against an annular ring 76 extending from the outer surface 74 of the outer tube 34, as shown in FIG. 7, to form the hermetic seal 136. In certain embodiments, the annular shoulder 90A of the specimen collection cap 86A may include a strengthening member 140 adjacent the sealing band 138 for providing additional rigidity to the specimen collection cap 86A during engagement with the inner tube 32 and/or the outer tube 34.

(46) The presence of the sealing band 138 at a bottom end 128A of the annular shoulder 90A allows for a reduction in the amount of material present in a pierceable septum 96A forming a barrier seal 122A with a portion of the interior 44 of the inner tube 32, thereby sealing the interior 44 from the external atmosphere. In this configuration, a seal 142 is formed by the interaction of the hermetic seal 136 and the interaction of a first protrusion 116A extending from the inner surface 114A of the annular shoulder 90A into the tube receiving portion 94A and the annular ring 52 of the inner tube 32. The seal 142 and the hermetic seal 136 form a tortuous path between the external atmosphere and the barrier seal 122A further enhancing the overall sealing system of the specimen collection container assembly 30, shown in FIG. 1.

(47) In one embodiment, the engagement of the sealing band 138 and the annular ring 76 extending from the outer surface 74 of the outer tube 34 produces an audible and/or tactile indication that the specimen collection cap 86A and the outer tube 34 with the inner tube 32 disposed therein are sealingly engaged. In one configuration, the annular ring 76 may include a resistance protrusion and the sealing band 138 may include a corresponding resistance recess for accommodating the resistance protrusion therein.

(48) As shown in FIGS. 11-12, the annular shoulder 90A of the specimen collection cap 86A may include a plurality of alternative ribs 132A extending along a portion of an exterior surface 134A of the annular shoulder 90A. These ribs 132A may be used to help identify the intended contents of the inner tube 32, additives and/or amounts of additives present within the inner tube 32, and/or the intended testing procedure to be performed on the contents of the inner tube 32.

(49) As shown in FIGS. 15-17, the specimen collection cap 86A is also suitable for use with inner tube 32 having dual funnels 46A, 46B. Referring specifically to FIG. 17, the dual funnels 46A, 46B are each received within the tube receiving portion 94A, as described herein.

(50) Referring to FIGS. 18-22, an alternative specimen collection cap 86B is shown. The specimen collection cap 86B is adapted for use with the inner tube 32 and/or the outer tube 34 as described herein, and is substantially similar to the specimen collection cap 86, with several alternatives. Specifically, in accordance with an embodiment of the present invention, the specimen collection cap 86B includes a top surface 88B having an annular shoulder 90B depending therefrom and at least partially surrounding the pierceable septum 96B. In this configuration, the pierceable septum 96B includes a base portion 144 and an outer portion 146 circumferentially disposed about the base portion 144 and defining a tube receiving portion 148 therebetween.

(51) When the specimen collection cap 86B and the inner tube 32 and outer tube 34 are assembled, the funnel 46, such as dual funnels 46A, 46B, is received within the tube receiving portion 148. The tube receiving portion 148 may be dimensioned such that a spacing gap 152 is present on either side of the funnels 46A, 46B when the inner tube 32 is engaged with the specimen collection cap 86B. The spacing gap 152 reduces contact between the funnels 46A, 46B and the pierceable septum 96B during assembly of the specimen collection cap 86B and the inner tube 32. This may be particularly advantageous for preventing or minimizing pull-away of the pierceable septum 96B during disengagement of the specimen collection cap 86B and the inner tube 32.

(52) In a further embodiment, a bottom end 150 of the outer portion 146 of the pierceable septum 96B may include a tapered surface 154 for guiding the open top end 38, particularly the funnels 46A, 46B into the tube receiving portion 148 of the pierceable septum 96B.

(53) The pierceable septum 96B may contact and form a barrier seal 122 with a portion of the interior 44 of the inner tube 32, thereby sealing the interior 44 from the external atmosphere, as described herein. The pierceable septum 96B may also form a perimeter seal 156 between a portion of the outer portion 146 and the annular ring 52 of the inner tube 32. In certain configurations, an upper tip 160 of the funnels 46A, 46B may contact an uppermost region 162 of the tube receiving portion 148 forming a tertiary seal 164 therebetween. The tertiary seal 164 and the perimeter seal 156 form a tortuous path between the external atmosphere and the barrier seal 122 further enhancing the overall sealing system of a specimen collection container assembly 30B, shown in FIG. 18.

(54) In a further embodiment, an inner surface 114B of the annular shoulder 90B may include a septum restraining portion 112B for preventing the inadvertent advancement of the pierceable septum 96B through the specimen collection cap 86B when pressure is applied to the pierceable septum 96B by a needle cannula or probe. The septum restraining portion 112B extends at least partially into the pierceable septum 96B for creating a physical restraint therebetween. In still a further embodiment, the pierceable septum 96B may include a restraining portion 170 for bearing against an inner surface 172 of the top surface 88B for preventing inadvertent disengagement of the specimen collection cap 86B.

(55) As shown in FIGS. 18-19, the annular shoulder 90B of the specimen collection cap 86B may include a plurality of alternative ribs 132B extending along a portion of an exterior surface 134B of the annular shoulder 90B. These ribs 132B may be used to help identify the intended contents of the inner tube 32, additives and/or amounts of additives present within the inner tube 32, and/or the intended testing procedure to be performed on the contents of the inner tube 32.

(56) While specific embodiments of the invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives to those details could be developed in light of the overall teachings of the disclosure.