巴西专利BR112013013251B1 sample collection container

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专利摘要:
SAMPLE COLLECTION CONTAINER SET Sample collection container that includes inner and outer tubes. The inner tube includes a bottom end, a top end, and a side wall extending between them defining an interior. The side wall includes an inner surface and an outer surface having at least one annular prominence extending from them. The inner tube includes at least a funnel portion adjacent the top end for directing a sample into the inner tube, and an annular ring arranged around a portion of the outer surface of the side wall adjacent the top end. The outer tube includes a bottom end, a top end, and a side wall extending between them, with the side wall having an inner surface and an outer surface defining an annular indent adapted for admitting a portion of the annular prominence to the same. The inner tube is disposed within the outer tube and with a portion of the top end of the outer tube confining the annular ring.
公开号:BR112013013251B1
申请号:R112013013251-5
申请日:2011-11-15
公开日:2020-11-24
发明作者:Benjamin R. Bartfeld；Robert G. Ellis；Robert S.Golabek Jr；Nancy Dubrowny；Girish Parmar；Paul Holmes；Michael Delk；Alex Blekher
申请人:Becton, Dickinson And Company；
IPC主号:

专利说明:

[0001] [001] This application claims priority regarding US Provisional Patent Application No. 61/419587, filed on December 3, 2010, entitled "Specimen Collection Container Assembly", the entire content of which is incorporated in this report as a reference. Fundamentals of the invention Field of the Invention
[0002] [002] The present invention is aimed at a sample collection container set and, more particularly, a sample collection container set showing improved sterility and being suitable for use in automated clinical processes. Description of the Related Technique
[0003] [003] Containers for the collection of medical capillary vessels have historically been used for the collection of samples, such as blood fluids and other types of bodily fluids, intended for diagnostic testing performance purposes. Most of these capillary collection containers include a spoon or funnel for directing a sample into the collection container. In most cases, sample collection containers in capillary vessels are not sterilized. In order to improve the quality of the sample, there is a desire to have the capillary collection devices sterilized. In addition, there is still a desire to provide a capillary collection device where the spoon or funnel is kept in a sterile condition before being used. Once the sample is deposited inside the sample collection container, it is often desirable to keep the sample in a pristine condition before carrying out the intended diagnostic test procedure.
[0004] [004] In addition, clinical laboratory processes that make use of sample collection containers are becoming increasingly automated. For this purpose, many containers for collecting samples of conventional capillary vessels are not compatible with the processes of automated front ends in reference to the preparation of an appropriate sample for analysis, with sample collection containers sorted by type and / or content, containers for sample collection by superficially watching or incorporating specific additives to the content relevant to the container for sample collection, centrifugation, analysis of the sample quality with visual basis, analysis of the serum level, de-capping, division, automated labeling of secondary tubes. In addition, many containers for sampling conventional capillary vessels are not compatible with automated analytical procedures and are not sized to accommodate automated diagnostics and / or the analysis of probes or other types of sample extraction equipment. It is also noted that many sample collection containers of conventional capillary vessels are not compatible with certain state-of-the-art automated processes employed after the analysis of a sample has occurred, such as resealing, storage, and restoration. Summary of the invention
[0005] [005] Consequently, there is a need for a capillary vessel sample collection container to have improved sealing mechanisms aimed at maintaining the sterility of the interior of the sample collection container and / or the interior and exterior of the spoon or of the funnel. It is also desirable to maintain the purity of the sample deposited inside the sample collection container before performing a test procedure.
[0006] [006] In addition, there is an additional need for a sample collection container that is compatible with automated clinical laboratory processes, including front end automation, automated analyzers, and / or safety end automation.
[0007] [007] In accordance with an embodiment of the present invention, a sample collection container includes an inner tube having a closed bottom end, a top end, and a side wall extending between them defining an interior for the inner tube. The side wall includes an inner surface and an outer surface having at least one annular prominence extending therefrom. The inner tube further includes at least a tapered portion adjacent the end and top for directing a sample into the inner tube, and an annular ring disposed around a part of the outer surface of the side wall adjacent the top end. The sample collection vessel further includes an outer tube including a bottom end, a tip end, and a side wall extending between them. The side wall includes an outer surface and an inner surface defining an annular indentation adapted to admit at least a part of the annular prominence therein. The inner tube is positioned at least partially inside the outer tube and a portion of the top end of the outer tube abutting the annular ring.
[0008] [008] In certain configurations, the inner tube and the outer tube are co-formed. The open top end of the inner tube can include a second funnel, so that this second funnel is substantially opposite the funnel. Optionally, at least one of the side walls of the inner tube and the side wall of the outer tube includes at least one fill line. In other types of configurations, the closed bottom end of the outer tube includes at least one vent for air ventilation from the space defined between the inner surface of the outer tube and the outer surface of the inner tube. The outer surface of the inner tube can include at least one stabilizer extending from it to contact a part of the inner surface of the outer tube. In certain configurations, the inner tube can completely seal the top end of the outer tube.
[0009] [009] In other configurations, the sample and collection container may include a sample collection cap sealing at least the top end of the inner tube and the top end of the outer tube. The sample collection cap may include a top surface, an annular shoulder dependent on it, and an annular inner wall dependent on the top surface containing the annular shoulder circumferentially arranged around the inner annular wall. A tube inlet part can be defined between the annular shoulder and the inner annular wall, and at least a part of the funnel can be admitted inside the tube inlet part.
[0010] [010] In still other configurations, the annular shoulder may include an inner surface showing a first prominence extending from it to the inside of the tube inlet part, and a second prominence extending from it to the inside of the part tube admission, with the first prominence showing laterally in relation to the second prominence. In addition, a prominence can be arranged on the outer surface of at least either the inner or outer tube, with the prominence being positioned between the first prominence and the second prominence of the annular boss when the sample collection cap seals at least the end top of the inner tube and the top end of the outer tube. The inner surface of the annular shoulder may also include a third prominence arranged around a bottom end of the sample collection cap extending inside the tube inlet part to contact at least a part of the side wall or the tube internal or external.
[0011] [011] The sample collection cap may also include an elastomeric plug, at least partially, encased by the internal annular wall. The elastomeric plug can be self-sealing. The elastomeric plug may include a concave intake surface adjacent to the top surface of the sample collection cap for directing an instrument to the apex of the concave intake surface. Optionally, the elastomeric plug may include an inverted intake surface adjacent to the top end of the sample collection cap. The sample collection cap may further include a plurality of ribs extending along part of an external surface of the annular shoulder.
[0012] [012] In one configuration, the sample collection cap includes an upper surface and an annular shoulder dependent on it incorporating an inner surface, with at least part of the inner surface of the annular boss and the outer surface of the inner tube interacting to forming a fence. The seal may include a winding path to the fluid.
[0013] [013] In another type of configuration, the sample collection cap includes a top surface and an annular shoulder dependent on it incorporating an inner surface where at least part of the inner surface of the annular boss and the outer surface of the outer tube interact to form a fence. The seal may include a winding path to the fluid. Brief description of the drawings
[0014] [014] FIG. 1 consists of a perspective view directed in front of a sample collection container assembly in accordance with an embodiment of the present invention.
[0015] [015] FIG. 2 consists of a perspective view of the lid of the sample collection container assembly shown in FIG. 1 according to an embodiment of the present invention.
[0016] [016] FIG. 3 consists of a cross-sectional view of the cover shown in FIG. 2 taken along line 3-3 according to an embodiment of the present invention.
[0017] [017] FIG. 4 consists of a front view of the inner tube showing a funnel for the sample collection container shown in FIG. 1 according to an embodiment of the present invention.
[0018] [018] FIG. 5 consists of a front view of an alternate inner tube showing double funnels of the sample collection container shown in FIG. 1 according to an embodiment of the present invention.
[0019] [019] FIG.6 consists of a front view of the outer tube of the sample collection container shown in FIG. 1 according to an embodiment of the present invention.
[0020] [020] FIG. 7 consists of a front view of an alternative external tube showing an annular prominence of the sample collection container shown in FIG.1 in accordance with an embodiment of the present invention.
[0021] [021] FIG. 8 consists of a side view of the cross section of the sample collection container assembly shown in FIG. 1 taken along line 8-8 according to an embodiment of the present invention.
[0022] [022] FIG. 9 consists of an enlarged cross-sectional view of the cover shown in FIG. 8 taken along segment 9 according to an embodiment of the present invention.
[0023] [023] FIG. 10 consists of a perspective view directed in the frontal direction of an alternative embodiment of a sample collection container set according to an embodiment of the present invention.
[0024] [024] FIG. 11 consists of a perspective view of the lid of the sample collection container assembly shown in FIG. 10 according to an embodiment of the present invention.
[0025] [025] FIG. 12 consists of a cross-sectional view of the cover shown in FIG. 11 taken along line 12-12 according to an embodiment of the present invention.
[0026] [026] FIG. 13 consists of a side view of the cross section of the sample collection container set shown in FIG. 10 taken along line 13-13 in accordance with an embodiment of the present invention.
[0027] [027] FIG. 14 consists of an enlarged cross-sectional view of the cover shown in FIG. 13 taken along segment 14 according to an embodiment of the present invention.
[0028] [028] FIG. 15 consists of a perspective view directed towards the front of an alternative embodiment of a sample collection container set in accordance with an embodiment of the present invention.
[0029] [029] FIG. 16 consists of a side view of the cross section of the sample collection container assembly shown in FIG. 15 taken along line 16-16 in accordance with an embodiment of the present invention.
[0030] [030] FIG. 17 consists of an enlarged cross-sectional view of the cover shown in FIG. 16 taken along segment 17 according to an embodiment of the present invention.
[0031] [031] FIG. 18 consists of a perspective view directed in front of an alternative embodiment of a sample collection container set in accordance with an embodiment of the present invention.
[0032] [032] FIG. 19 consists of a perspective view of the lid of the sample collection container assembly shown in FIG. 18 in accordance with an embodiment of the present invention.
[0033] [033] FIG. 20 consists of a cross-sectional view of the cover shown in FIG. 19 taken along line 20-20 in accordance with an embodiment of the present invention.
[0034] [034] FIG. 21 consists of a side view of the cross section of the sample collection container assembly shown in FIG. 18 taken along line 21-21 according to an embodiment of the present invention.
[0035] [035] FIG. 22 consists of an enlarged cross-sectional view of the cover shown in FIG. 21 taken along segment 22 according to an embodiment of the present invention. Detailed Description
[0036] [036] As shown in FIG. 1, a sample collection container set 30, such as a biological fluid collection container, includes an inner tube 32, an outer tube 34, and a sample cap 86. The inner tube 32, as shown in FIGS. 4-5, it is used to collect and contain a sample, such as capillary blood or some other type of body fluid, for later diagnostic testing and analysis procedures. The outer tube 34, as shown in FIGS. 6-7, acts primarily as a conductor 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 procedures, such as Clinical Laboratory Automation. The sample cap 86, shown according to FIGS 2-3, provides a mechanism for a user to access the inner tube 32 by obtaining the sample deposited there, and also provides a rupture-proof seal close to the inner tube. 32 by replacing the sample cap 86, as discussed below in this report.
[0037] [037] Referring specifically to FIGS. 4-5, the inner tube 32 includes an open top end 38, a closed bottom end 40, and a side wall 42 extending between them defining an inner inner tube 44 adapted for the admission of a sample therein. Referring to FIG. 4, the open top end 38 may include at least one funnel 46 or a spoon part for facilitating and directing a sample into the interior 44 of the inner tube 32. The funnel 46 may include at least one introduction surface 48 having a curvature for driving a sample into funnel 46 and going inside 44 of inner tube 32. When in use, funnel 46 can be positioned adjacent to a sample and used to "collect" the sample into inner tube 32. In certain circumstances, funnel 46 can be positioned adjacent to the patient's fingertip and funnel 46 can be used to collect blood from the capillary into the inner tube 32.
[0038] [038] With reference to FIG. 5, in other configurations, the open top end 38 of the inner tube 32 can include double hoppers 46A, 46B. The double funnels 46A, 46B can be protruding, so that the curvature of the introduction surface 48A of the first funnel 46A is compared with the corresponding curvature of the introduction surface 48B of the second funnel 46B, thereby forming a surface for the admission of the finger 50 When in use, a patient's fingertip can be placed in contact with the finger inlet surface 50 to direct blood from the capillary to the interior 44 of the inner tube 32.
[0039] [039] The inner tube 32 can also include an annular ring 52 disposed around part of the side wall 42. In certain configurations, the annular ring 52 is disposed adjacent to the open top end 38 and extends outwards from of the outer surface 54 of the sidewall 42. The inner tube 32 may further include an annular prominence 68 extending outwardly from the outer surface 54 of the sidewall 42. In another embodiment, the annular prominence 68 may extend inwardly into the inner tube 32. In certain configurations, the annular prominence 68 can be positioned below the annular ring 52.
[0040] [040] The open top end 38 of the inner tube 32 can be adapted to provide with an opening wide enough to allow for standard diagnosis and entry of sampling probes, needles, and / or similar extraction or deposition devices when entering at the open top end 38 and having access to the interior 44, for the purpose of depositing the sample or taking a sample on site. In one type of embodiment, the interior 44 of the inner tube 32 can include at least one surface with angular direction 58 directing a probe or other type of standard instrumental device towards the closed bottom end 40 of the inner tube 32. In certain configurations, it is desirable that both the introduction surface 48 of the funnel 46 and the surface with angular direction 58 are well-defined and graduated surfaces 48 to promote the flow of the sample into the interior 44 of the inner tube 32.
[0041] [041] In one type of embodiment, the dimensions of the inner tube 32 are balanced so that the open top end has an opening containing a sufficiently wide W, as shown in FIG. 4, allowing a standard probe to pass through, and still having an inner tube diameter D sufficient to provide a greater column extension for the sample disposed inside the inner tube 32.
[0042] [042] During the sampling procedure, an increase in the height of the sample column inside the inner tube 32 provides a greater volume of the sample that can be recovered or extracted by the analysis probe (not shown).
[0043] [043] At least one stabilizer 56 can be provided close to the outer surface 54 of the side wall 42. The stabilizer 56, as shown in FIGS. 4-5 can take any suitable shape so that an outer surface 59 contacts at least part of the outer tube 34, as shown in FIGS. 6-7. With reference to FIGS. 6-7, the outer tube 34 has an open top end 60, a closed bottom end 62, and a side wall 64 extending between them and forming an inner tube 66. The side wall 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 in a portion of the sidewall 64, such as within the inner surface 72 of a portion of the sidewall 64 adjacent to the open top end 60 The recess 70 is adapted to admit at least a part of the annular prominence 68 of the inner tube 32 therein during installation.
[0044] [044] With reference to FIG. 7, the outer surface 74 may further include an annular ring 76 extending outwardly from the outer surface 74 of the side wall 64 adjacent to the open top end 60. In certain configurations, the annular ring 76 is positioned below the recess 70 along side wall 64.
[0045] [045] Referring again to FIGS. 6-7, the outer tube 34 is dimensioned for the admission of the inner tube, as shown in FIGS. 4-5, at least partially therein, as shown in FIGS. 8-9. In one type of embodiment, the outer tube 34 has sufficient internal dimensions to accommodate the inner tube 32 therein. During installation, the inner tube 32 can be at least partially positioned inside the outer tube 34 so that an upper end 78 of the outer tube 34 confines the annular ring 52 of the inner tube 32 allowing an intake part of the inner tube having a length L, shown in FIG. 4, an inlet part of the inner tube 32 having a diameter D1, dimensioned to be admitted inside the inner part of the outer tube 66, becoming smaller than the inner diameter D3 of the outer tube 34, as shown in FIG. 6. The annular ring 52 of the inner tube 32 is dimensioned to restrict any additional part of the inner tube 32 from passing inside the outer tube 34 and having a diameter D2, as shown in FIG. 4, which is greater than the inner diameter D3 of the outer tube 34. According to the description above, during installation, the recess 70 of the outer tube 34 is adapted to admit at least part of the annular prominence 68 of the tube internal 32 therein, as shown in FIGS. 8-9.
[0046] [046] Although the inner tube 32 and the outer tube 34 can assume any suitable dimensions, the inner tube can assume an overall length L2 of around 48 mm, as shown in FIG. 5, and can assume an inner diameter of tube D of around 7 mm, as shown in FIG. 4. The outer tube 34 can assume any suitable dimensions that are compatible with industry standard specifications in relation to automated clinical procedures, such as incorporating an overall L3 length of around 69 mm, as shown in FIG. 6, and an external diameter D4 of around 13 mm. The outer tube 34 can also be sized to accommodate standard size labels applied to the outer surface 74 and can be sized to improve manipulation by the clinician. This can be particularly advantageous when collecting small volumes of groups of samples. A clinician can manipulate the outer tube 34, which is significantly easier to be safe, while proceeding to collect a small volume of sample inside the inner tube 32 positioned inside the outer tube 34. When the inner tube 32 and the outer tube 34 are installed, the overall length L5 can assume an industry standard length of 75 mm, as shown in FIG. 8, or an industry standard length of 100 mm.
[0047] [047] In one embodiment, the inner tube 32 and the outer tube 34 can be molded inline, where both the inner tube 32 and the outer tube 34 come to be molded in the same press and installed, as opposed to being molded separately and subsequently installed. Alternatively, the inner tube 32 and the outer tube 34 can be adjusted by pressure within the same forming process. Through the joint formation of both the inner tube 32 and the outer tube 34, the tolerances of the relative engagement occurring between the inner tube 32 and the outer tube 34 can be improved due to the relative shrinkage rate becoming identical for both tubes. In certain types of configurations, the inner tube 32 and the outer tube 34 can be formed from the same material, such as polypropylene and / or Polyethylene. In other configurations, the inner tube 32 and the outer tube 34 can be formed of two differentiated polymeric materials. In certain modalities, it can be observed that a set with an inner tube 32 and an outer tube 34 incorporating thin walls allows the optical transparency of the sample when viewed by the automated visualization system, taking into account the quality of detection and the sample. In addition, greater optical transparency can assist in better medical practice during sample collection.
[0048] [048] During the installation and / or formation of the inner tube 32 and the outer tube 34, air may be trapped between the inner surface 72 of the outer tube 34 and the outer surface 54 of the side wall 42 of the inner tube 32. Consequently, the bottom end 62 of the outer tube 34 can include a vent 80, as shown in FIG. 7, to allow the air captured between the inner surface of the outer tube 34 and the outer surface 54 of the side wall 42 of the inner tube 32 to escape between them. In certain configurations, the vent 80 can also assist in the molding process of the inner tube 32 by locking the central pin of the mold during the molding process preventing a relative deviation between the outer tube 34 and the formation of the inner tube 32.
[0049] [049] In an embodiment of the present invention, at least the inner tube 32 and the outer tube 34 include at least one fill line 82, shown in FIGS. 4-5, allowing a clinician to determine the volume of samples present inside the inner tube 32. In another embodiment, at least the inner tube 32 and the outer tube 34 include an additive for blocking light or colors 84, as shown in FIG. 8. The additive can allow enough light to pass through the side wall 42 of the inner tube 32 allowing a clinician to view the contents of the interior 44 of the inner tube 32, and can also prevent the passage of light through the wall side 42 of the inner tube 32 that could compromise or alter in any way the content in the inner tube 32. This application is particularly useful in the case of samples collected for light sensitive analyzers, such as Bilirubin, since the light degrades the quality of the sample required for such a test procedure. In one embodiment, the additive can be sprayed, coated, or in-molded with at least inner tube 32 and outer tube 34. In another embodiment, the additive is designed to block only the passage of certain wavelengths light through the side wall 42 of the inner tube 32.
[0050] [050] With reference to FIGS. 2-3, a sample 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 tube is installed inner 32 and outer tube 34, the open top end 60 of outer tube 34 is sealed by the open top end 38 of inner tube 32, specifically by annular ring 52 of inner tube 32. Consequently, in this configuration, the collection cap sample 86 can seal not only the open top end 38 of the inner tube 31 but also effectively seal the open top end 60 of the outer tube 34. The sample collection cap 86 includes a top surface 88 and an annular shoulder 90 dependent on it. The sample collection cap 86 may further include an annular inner wall 92 dependent on the top surface 88, with the annular shoulder 90 circumferentially positioned around the annular inner wall 92 and spaced from it by a tube inlet part 94.
[0051] [051] In one embodiment, an elastomeric plug or puncture septum 96 can be arranged at least partially within the annular inner wall 92 and extending between them forming a sealing body within the sample collection cap 86 In one embodiment, the puncture septum 96 is formed from a thermoplastic elastomer (TPE). Puncture septum 96 can be pierced by an injection probe or straw, as conventionally known, and can be self-sealing. The puncturing septum 96 can be formed through a protruding flow channel 98, described in accordance with US Patent Application No. 2009/0308184, the full description of which is incorporated in this report for reference. The puncturing septum 96 may include a concave intake surface 100 adjacent to the top surface 88 for directing an instrument, such as an injection probe or straw, to the apex 102 of the concave intake surface 100. This gives conditions to a clinician more easily determines the proper alignment of the insertion straw or probe for puncturing the puncture septum 96. An opening 104 within the top surface 88 of the sample collection cap 86 can be further sized to accommodate the probes and insertion straws within the clinical standard, both for hematological and chemical analysis. The puncturing septum 96 further includes a sample targeting surface 106 for tapering a sample close to an apex 108 of the sample collection cap 86 when the sample collection container assembly 30, shown in FIG. 1, is inverted for sample removal, in accordance with the description provided in US Patent Application No. 2009/0308184.
[0052] [052] Referring again to FIG. 3, the annular inner wall 92 may have an inner surface 110 contacting the puncturing septum 96. A portion of the inner wall 110 of the annular inner wall 92 may include a septum restraint part 112 for preventing unexpected advance of the puncturing septum. 96 through the sample collection cap 86 when applying pressure near the puncture septum 96 through a probe or an insertion straw. The septum restraint portion 112 partially extends into the puncturing septum 96 to create a physical constraint between them.
[0053] [053] The annular shoulder 90 of the sample collection cap 86 has an inner surface 114 showing a first prominence 116 extending from the inner surface 114 into the tube inlet part 94, and a second prominence 118 extending to from the inner surface 114 into the tube inlet part 94. The first prominence 116 is spaced from the second prominence 118, laterally protruding from it along a part of the inner surface 114 of the annular shoulder 90. The first prominence 116 and the second prominence 118 may extend in an annular direction towards the tube inlet part 94.
[0054] [054] As shown in FIGS. 8-9, when the sample collection cap 86 and the inner tube 32 and the outer tube 34 are combined, the annular shoulder 90 is positioned on the outer surface 54 of the side wall 42 of the inner tube 32 and the outer surface 74 from the side wall 64 of the outer tube 34. The punching septum 96 contacts and forms a barrier seal 122 with an inner portion 44 of the inner tube 32, thereby sealing the inner 44 of the outer atmosphere. The funnel 46, and the open top end 38 portions of the inner tube 32 and the open top end 60 portions of the outer tube 34 are admitted within the tube inlet part 94. The first prominence 116 and the second prominence 118 constitute a first recess 120 between them for accommodating the annular ring 52 of the inner tube 32 therein, thereby forming a first seal 124 between the sample collection cap 86 and the inner tube 32.
[0055] [055] Referring again to FIG. 3, the sample collection cap 86 may further include a third prominence 126 extending from the inner surface 114 of the annular shoulder 90 into the tube inlet part 94. The third prominence 126 may extend in an annular direction towards the tube inlet part 94 and can be provided adjacent the bottom end 128 of the annular shoulder 90. Referring again to FIG. 9, when the sample collection cap 86, the inner tube 32, and the outer tube 34 are combined, the third prominence 126 can engage a part of the outer surface 74 of the side wall 64 of the outer tube 34 forming a second seal 130.
[0056] [056] The barrier seal 122 formed between the puncture septum 96 and the interior 44 of the inner tube 32 preserves the interior 44 in a sterile condition before receiving a sample therein. The barrier seal 122 also maintains the condition of the sample present inside the inner tube 32 after resealing or sealing the puncturing septum 96. The first seal 124 and the second seal 130 form a winding path between the external atmosphere and the barrier seal 122 further accentuating the generic sealing system of the sample collection container assembly 30, shown in FIG. 1. In addition, the first seal 124 and the second seal 130 preserve funnel 46 in a sterile condition before use.
[0057] [057] Optionally, as shown in FIGS. 1-2, the annular shoulder 90 of the sample collection cap 86 can include a plurality of ribs 132 extending along part of an outer surface 134 of the annular shoulder 90. These ribs 132 can be used to assist in identifying the targeted contents of the inner tube 32, additives and / or the amounts of additives present inside the inner tube 32, and / or in the intended testing procedures to be performed along with the contents in the inner tubes 32.
[0058] [058] With reference to FIGS. 10-14, an alternative sample collection cap 86A is provided. The sample collection cap 86A is adapted for use with the inner tube 32 and / or the external tube 34 according to the description given in this report, being substantially similar to the sample collection cap 86, presenting several alternatives. Specifically, a sealing strip 138 is positioned in an annular direction around an internal surface 114A of an annular shoulder 90A extending into a pipe inlet part 94A. The sealing strip 138 forms an airtight seal 136 with a portion of the outer surface 74 of the outer tube 34. In one embodiment, the sealing strip 138 is deformable against an annular ring 76 extending from the outer surface 74 of the tube external 34, as shown in FIG. 7, constituting the hermetic seal 136. In certain embodiments, the annular shoulder 90A of the sample collection cap 86A may include a reinforcement component 140 adjacent to the sealing strip 138 to provide additional stiffness relating to the sample collection cap 86A during the engagement with the inner tube 32 and / or the outer tube 34.
[0059] [059] The presence of the sealing strip 138 next to a bottom end 128A of the annular shoulder 90A allows a reduction in the amount of material present in a puncturing septum 96A forming a barrier seal 122A with an inner part 44 of the tube internal 32, thereby sealing the interior 44 from the presence of 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 prominence 116A extending from the inner surface 114A of the annular shoulder 90A at the tube inlet part 94A and the annular ring 52 of the inner tube 32 The seal 142 and the hermetic seal 136 form a winding path between the external atmosphere and the barrier seal 122A further accentuating the generic sealing system of the sample collection container set 30, shown in FIG. 1.
[0060] [060] In a type of embodiment, the sealing strip engagement 138 and the annular ring 76 extending from the outer surface 74 of the outer tube 34 produce an audible and / or tactile indication of whether the sample collection cap 86A and the outer tube 34 with the inner tube 32 disposed therein are engaged in a sealed manner. In one type of configuration, the annular ring 76 may include a resistance prominence and the sealing strip 138 may include a corresponding resistance indentation to accommodate the resistance prominence therein.
[0061] [061] As shown in FIGS. 11-12, the annular shoulder 90A of the sample collection cap 86A may include a plurality of alternative ribs 132A extending along part of an outer surface 134A of the annular shoulder 90A. These ribs 132A can be used to assist in identifying the desired content of the inner tube 32, additives and / or the amounts of additives present within the inner tube 32, and / or in the intended testing procedures to be performed along with the content present in the inner tube 32.
[0062] [062] As shown in FIGS. 15-17, the 86A sample collection cap is also suitable for use with the inner tube 32 featuring double funnels 46A, 46B. With reference specifically to FIG. 17, double hoppers 46A, 46B are each admitted within the tube inlet part 94A, as described in this report.
[0063] [063] With reference to FIGS. 18-22, an alternative sample collection cap 86B is presented. The sample collection cap 86B is adapted for use with the inner tube 32 and / or the outer tube 34 as described in this report, being substantially similar to the sample collection cap 86, incorporating several alternatives. Specifically, according to an embodiment of the present invention, the sample collection cap 86B includes a top surface 88B having an annular shoulder 90B dependent on it and at least partially surrounding the puncturing septum 96B. In this configuration, the punching septum 96B includes a base part 144 and an outer part 146 circumferentially arranged around the base part 144 and defining a tube inlet part 148 between them.
[0064] [064] When the sample collection cap 86B and the inner tube 32 and the outer tube 34 are installed, hopper 46 is admitted, as well as double hoppers 46A, 46B, inside the tube intake part 148. The tube inlet part 148 can be dimensioned so that a gap clearance 152 is present on each side of the funnels 46A, 46B when the inner tube 32 is engaged with the sample collection cap 86B. Spacing clearance 152 reduces contact between funnels 46A, 46B and puncturing septum 96B when installing the sample collection cap 86B and inner tube 32. This can be particularly advantageous for preventing or minimizing the extraction thrust puncture septum 96B when disengaging the sample collection cap 86B and inner tube 32.
[0065] [065] In a later embodiment, a bottom end 150 of the outer part 146 of the puncturing septum 96B may include a thinned surface 154 for guiding the open top end 38, particularly the funnels 46A, 46B in the tube inlet part 148 puncture septum 96B.
[0066] [066] Punching septum 96B can contact and form a barrier seal 122 with a part of the interior of the inner tube 32, thereby sealing the interior 44 from the presence of the external atmosphere, according to the description given in this report. Punching septum 96B may also form a seal at perimeter 156 between an outer portion 146 and annular ring 52 of inner tube 32. In certain configurations, an upper tip 160 of funnels 46A, 46B may contact an outer region 162 of the pipe inlet part 148 constituting a tertiary seal 164 between them. The tertiary seal 164 and the perimeter seal 156 form a winding path between the external atmosphere and the barrier seal 122 thereby accentuating the generic sealing system of a sample collection container set 30B, as shown in FIG. 18.
[0067] [067] In an additional embodiment, an internal surface 114B of the annular shoulder 90B may include a septum restraint part 112B for preventing unexpected advance of the puncturing septum 96B through the sample collection cap 86B when applying pressure close to the puncture septum 96B by means of a probe or an insertion straw. The septum restraint portion 112B extends at least partially to the puncturing septum 96B to create a physical constraint between them. In still a later embodiment, the puncturing septum 96B may include a restraint portion 170 to support an inner surface 172 of the top surface 88B to prevent an unexpected disengagement of the sample collection cap 86B.
[0068] [068] As shown in FIGS. 18-19, the annular shoulder 90B of the sample collection cap 86B may include a plurality of alternative ribs 132B extending over a portion of an outer surface 134B of the annular shoulder 90B. These ribs 132B can be used to aid in the identification of the desired content of the inner tube 32, additives and / or in the quantities of additives present inside the inner tube 32, and / or in the intended testing procedures to be performed with the content present in the inner tube 32.

权利要求:
Claims (22)
[0001]
Sample collection container, FEATURED by the fact comprising: an inner tube (32) having a closed bottom end (40), a top end (38), and a side wall (42) extending between them defining an inner tube interior (44), the side wall ( 42) having an inner surface and an outer surface (54) having at least one annular prominence (68) extending from it, the inner tube (32) comprising at least one funnel (46, 46A) adjacent the end top (38) for directing a sample into the inner tube (44), and an annular ring (52) arranged around a part of the outer surface (54) of the side wall (42) adjacent to the top end (38), the funnel (46, 46A) being adjacent to and above the annular ring (52); and an outer tube (34) comprising a bottom end (62), a top end (60) including an upper end (78), and a side wall (64) extending between them, the side wall (64) having an outer surface (74) and an inner surface (72) defining an annular indentation (70) adapted to admit at least a part of the annular prominence (68) therein, in which the inner tube (32) is arranged, at least at least partially inside the outer tube (34), such that the funnel (46, 46A) is above the upper end (78) and a part of the upper end (78) of the outer tube (34) adjoins the annular ring (52) .
[0002]
Sample collection container, according to claim 1, CHARACTERIZED by the fact that the inner tube (32) and the outer tube (34) are co-formed.
[0003]
Sample collection container according to claim 1, CHARACTERIZED by the fact that the open top end (38) of the inner tube (32) comprises a second funnel (46B), so that the second funnel (46B) substantially opposite the funnel (46A).
[0004]
Sample collection container according to claim 1, CHARACTERIZED by the fact that at least one of the side walls (42) of the inner tube (32) and the side wall of the outer tube (34) include at least one fill line (82).
[0005]
Sample collection container, according to claim 1, CHARACTERIZED by the fact that the bottom end (62) of the outer tube (34) comprises at least one vent (80) for ventilation of the air coming from the defined space between the surface inner (72) of the outer tube (34) and the outer surface (54) of the inner tube (32).
[0006]
Sample collection container, according to claim 1, CHARACTERIZED by the fact that the outer surface (54) of the inner tube (32) comprises at least one stabilizer (56) extending from it to contact a part of the inner surface (72) of the outer tube (34).
[0007]
Sample collection container, according to claim 1, CHARACTERIZED by the fact that the inner tube (32) completely seals the top end (60) of the outer tube (34).
[0008]
Sample collection container according to claim 1, CHARACTERIZED by the fact that it also comprises a sample collection cap (86) sealing at least one of the top ends (38) of the inner tube (32) and the end of top (60) of the outer tube (34).
[0009]
Sample collection container according to claim 8, CHARACTERIZED by the fact that the sample collection lid (86) includes a top surface (88), an annular shoulder (90) dependent on it, and an inner wall annular (92) dependent on the top surface (88) with the annular shoulder (90) circumferentially arranged around the inner annular wall (92).
[0010]
Sample collection container, according to claim 9, CHARACTERIZED by the fact that a tube intake part (94) is defined between the annular shoulder (90) and the annular inner wall (92), and in which at least a part of the funnel (46) is admitted inside the tube inlet part (94).
[0011]
Sample collection container, according to claim 10, CHARACTERIZED by the fact that the annular shoulder (90) comprises an internal surface (114) presenting a first prominence (116) extending from it to the admission part of tube (94), and a second prominence (118) extending from it to the tube inlet part (94), the first prominence (116) laterally protruding from the second prominence (118).
[0012]
Sample collection container, according to claim 11, CHARACTERIZED by the fact that it also comprises a prominence arranged on the outer surface (54, 74), at least, of the inner tube (32) and the outer tube (34), the prominence positioned between the first prominence (116) and the second prominence (118) of the annular boss (90) when the sample collection cap (86) seals at least one of the top ends (38) of the inner tube (32) and the top end (60) of the outer tube (34).
[0013]
Sample collection container, according to claim 10, CHARACTERIZED by the fact that the internal surface (114) of the annular shoulder (90) further comprises a third prominence (126) disposed around a bottom end (128) of the sample collection cap (86) extending to the tube inlet part (94) to contact a part of the side wall (42, 64), at least of the inner tube (32) and the outer tube (34).
[0014]
Sample collection container, according to claim 9, CHARACTERIZED by the fact that it also comprises an elastomeric plug (96) partially surrounded, at least, by the internal annular wall.
[0015]
Sample collection container, according to claim 14, CHARACTERIZED by the fact that the elastomeric plug (96) is self-sealing.
[0016]
Sample collection container according to claim 14, CHARACTERIZED by the fact that the elastomeric plug (96) comprises a concave intake surface (100) adjacent the top surface (88) of the sample collection cap (86) for directing an instrument to an apex (102) of the concave intake surface (100).
[0017]
Sample collection container according to claim 14, CHARACTERIZED by the fact that the elastomeric plug (96) comprises an inverted intake surface adjacent to a bottom end (128) of the sample collection cap (86).
[0018]
Sample collection container according to claim 9, CHARACTERIZED by the fact that it further comprises a plurality of ribs (132) extending along a part of an outer surface (134) of the annular shoulder (90).
[0019]
Sample collection container, according to claim 8, CHARACTERIZED by the fact that the sample collection lid (86) includes a top surface (88) and an annular shoulder (90) dependent on it with an internal surface ( 114), wherein at least a part of the inner surface (114) of the annular shoulder (90) and the outer surface (54) of the inner tube (32) interact to form a seal (124, 130).
[0020]
Sample collection container, according to claim 19, CHARACTERIZED by the fact that the seal (124, 130) comprises a winding fluid path.
[0021]
Sample collection container, according to claim 8, CHARACTERIZED by the fact that the sample collection lid (86) includes a top surface (88) and an annular shoulder (90) dependent on it with an internal surface ( 114), wherein at least a part of the inner surface (114) of the annular shoulder (90) and the outer surface (74) of the outer tube (34) interact to form a seal (124, 130).
[0022]
Sample collection container, according to claim 21, CHARACTERIZED by the fact that the seal (124, 130) comprises a winding fluid path.

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法律状态:
2018-04-03| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-06-04| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|

2020-04-07| B15K| Others concerning applications: alteration of classification|Free format text: A CLASSIFICACAO ANTERIOR ERA: B01L 3/14 Ipc: B01L 3/00 (2006.01) |

2020-04-07| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-11-24| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/11/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US41958710P| true| 2010-12-03|2010-12-03|

US61//419,587|2010-12-03|

US13/295,235|2011-11-14|

US13/295,235|US8460620B2|2010-12-03|2011-11-14|Specimen collection container assembly|

PCT/US2011/060781|WO2012074738A1|2010-12-03|2011-11-15|Specimen collection container assembly|

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