Sample container with physical fill-line indicator

[0001] The present invention relates to a biological sample container, and more particularly to a biological fluid collection container having at least one filling level line.

Description of the Related Art [0002] Biological sample containers have been used for a long time for sampling such as blood and other body fluids, for example for diagnostic tests. In many cases, a predetermined sample volume is required to perform a specific test, and such containers are often used to facilitate the collection of an accurate, test-specific sample volume, for example using a fluid collection container such as a blood collection tube . In certain sample containers of this type, a pre-measured amount of an additive, such as a preservative or anticoagulant, is added to the container for preservation or otherwise sample preparation. Therefore, it is important that the amount of fluid sample taken into the container corresponds to the volume of additive inside the container and / or the desired test volume.

[0003] Traditional methods for measuring sample volume have included placing an adhesive label on the outer surface of the sample container, in an exact location. This allows medical personnel to measure the volume of the sample by aligning the amount of liquid inside the container with the mark on the label, or the top or bottom of the label. However, this method may have significant disadvantages. Complex devices are needed to properly align the label on the outside of the sample container. Errors in label placement may be the source of inaccurate filling volumes and, consequently, inaccurate relevant test results, especially when it is necessary to properly maintain the relative proportions of the sample to the additives. Sample containers with poorly aligned labels are usually rejected as defective products and contribute to increased costs. In addition, labels affixed to the outside of the sample container may be damaged as a result of routine procedures, and may easily be blurred by additional patient or specimen marking.

[0004] US 2003/0059347 discloses a collection container with a line indicating the level of filling on its outer surface.

SUMMARY OF THE INVENTION [0005] Accordingly, there is a need for an improved sample container, allowing medical personnel to visually obtain the exact sample volume and / or total expected sample volume together with the reagent present in the container.

[0006] In accordance with an aspect of the present invention, the sampling container assembly includes a first opening, a first closed bottom, and a first side wall extending circumferentially between the first opening and the first closed bottom. This first cylindrical member can receive a sample of biological material. The container assembly further includes a second cylindrical container comprising a second opening, a second closed bottom, and a second side wall extending circumferentially between the second opening and the second closed bottom. The first cylindrical member is arranged inside the second cylindrical member. A line indicating the fill level is located on the second side wall. This fill level indicator line consists of an upper line and a lower line placed at a predetermined distance from each other. Hereinafter, the first cylindrical member is also referred to as the inner cylindrical member and the second cylindrical member is also referred to as the outer cylindrical member.

[0007] According to another aspect of the present invention, the biological sampling container assembly consists of a first cylindrical member comprising a first opening, a first closed bottom, and a first side wall extending circumferentially between the first opening and the first closed bottom. This first cylindrical member can receive a sample of biological material. The container assembly further includes a second cylindrical member comprising a second opening, a second closed bottom, and a second side wall extending circumferentially between the second opening and the second closed bottom. This second sidewall has an inner and outer surface and a line indicating the fill level integral with the inner surface of the second sidewall. The fill level indicator line consists of an upper line and a lower line placed at a predetermined distance from each other, and the first cylindrical member is located inside the second cylindrical member.

[0008] According to the present invention, the sampling container assembly includes a cylindrical member comprising an opening, a closed bottom, and a side wall extending circumferentially between the opening and the closed bottom. The cylindrical member may receive a sample of the preparation. The line indicating the fill level is placed on the inner surface of the side wall. The fill level indicator line consists of an upper line and a lower line placed at a predetermined distance from each other.

[0009] In accordance with yet another aspect of the present invention, a method of making a sampling container comprises forming a first cylindrical member comprising a first opening, a first closed bottom, and a first side wall extending circumferentially between the first opening and the first closed bottom. The first cylindrical member has a predetermined volume for receiving a sample of the preparation. The method further includes forming a second cylindrical member comprising a second opening, a second closed bottom, and a second side wall extending circumferentially between the second opening and the second closed bottom, providing a line indicating the level of filling on the second side wall, wherein the filling level indicator line consists of an upper line and a lower line placed at a predetermined distance from each other and placing the first cylindrical member inside the second cylindrical member.

[0010] In accordance with another aspect of the present invention, a method of making a sampling container comprises forming a cylindrical member comprising a first end, a second end, and a side wall extending circumferentially between the first end and the second end. The cylindrical member has a predetermined volume for receiving a sample of the preparation. The other end may be the closed bottom of the tube or it may be the open end so that a tube is formed at both ends. In this embodiment, both of these openings may be closed by separate closures. The method further includes providing a line indicating the fill level on the inner surface of the side wall. This filling level line consists of the top line and bottom line at a predetermined distance from each other.

[0011] According to a further aspect of the present invention, the filling level indicator line consists of an upper and lower line extending at least partially around the second sidewall and positioned at a predetermined distance from each other, the upper line defining the maximum expected volume fill, and the bottom line defines the minimum expected fill volume, and the distance between the top and bottom lines defines the interval, which holds the expected filling volume of the collection container.

[0012] The fill level indicating line may include a visual marking applied to the second side wall of the second cylindrical member. Alternatively, the fill level indicating line may be formed integrally from the molded material from which the cylindrical members are made, forming a textured surface on the second side wall of the second cylindrical member. This textured surface is capable of scattering light and / or forming an opaque surface on the container and can be produced on one of the tubes (tubes) during the injection molding process.

[0013] Further details and advantages of the invention will become apparent from the following description of preferred embodiments, taken into account with the accompanying drawings, in which like reference numerals indicate like elements.

BRIEF DESCRIPTION OF THE DRAWINGS [0014]

Fig. 1 is a perspective view of a container comprising a filling level line in the form of a single wide belt not forming part of the invention;

Fig. 2 is a perspective view of a container containing a pair of lines indicating the fill level in accordance with one aspect of the invention;

Fig. 3 is a perspective view of a container not forming part of the invention comprising a single fill level indicator line showing the minimum expected fill volume;

Fig. 4 is a cross-sectional view of the filling line in the form of the wide belt of Fig. 1 formed on the inner surface of a second tube in accordance with an embodiment not forming part of the invention;

Fig. 5 is a cross-sectional view of a pair of lines indicating the fill level of Fig. 2 formed on the inner surface of a second tube according to the first embodiments of the invention;

Fig. 6 is a cross-sectional view of the thin line indicating the fill level of Fig. 3 formed on the inner surface of a second tube in accordance with an embodiment not forming part of the invention;

Fig. 7 is a cross-sectional view of the line indicating the fill level in the form of the wide belt of Fig. 1 formed on the inner surface of the first tube in accordance with an embodiment not forming part of the invention;

Fig. 8 is a cross-sectional view of a pair of lines indicating the fill level of Fig. 2 formed on the inner surface of the first tube in accordance with an embodiment forming part of the invention;

Fig. 9 is a cross-sectional view of the thin line indicating the fill level of Fig. 3 formed on the inner surface of the first tube in accordance with an embodiment not forming part of the invention;

Fig. 10 is a cross-sectional view of the line indicating the fill level in the form of the wide belt of Fig. 1 formed on the outer surface of the first tube in accordance with an embodiment not forming part of the invention;

Fig. 11 is a cross-sectional view of a pair of lines indicating the fill level of Fig. 2 formed on the outer surface of the first tube in accordance with an embodiment not forming part of the invention;

Fig. 12 is a cross-sectional view of the thin line indicating the fill level of Fig. 3 formed on the outer surface of the first tube in accordance with an embodiment not forming part of the invention;

Fig. 13 is a cross-sectional view of the line indicating the fill level in the form of the wide belt of Fig. 1 formed on the inner surface of a single tube in accordance with an embodiment not forming part of the invention;

Fig. 14 is a cross-sectional view of a pair of lines indicating the fill level of Fig. 2 formed on the inner surface of a single tube according to the invention;

Fig. 15 is a cross-sectional view of the thin line indicating the fill level of Fig. 3 formed on the inner surface of a single tube in accordance with an embodiment not forming part of the invention; and

Fig. 16 is a perspective view of an open tube from both ends in accordance with another embodiment not forming part of the invention.

DETAILED DESCRIPTION OF THE INVENTION [0015] For the purposes of the remainder of the description, spatial or directional terms will refer to the invention in accordance with the orientation in the drawings. However, it should be understood that the invention may accept a variety of alternative variants unless expressly stated otherwise. It should also be understood that the specific components illustrated in the accompanying drawings and described in the following description are simply embodiments of the invention. Therefore, the specific dimensions and other physical properties associated with the embodiments disclosed herein should not be considered as limiting.

[0016] We now refer to Figures 1-3 showing a perspective view of a collection container, generally designated 10, such as a container for collecting biological fluid samples. The container 10 comprises a cylindrical member having an opening 12, a closed bottom 14, and a side wall 16 extending circumferentially between the opening 12 and the closed bottom 14, which form a tube. The container 10 has a predetermined internal volume that allows sample preparation. The filling level indicator line, generally indicated as 18, is located on the side wall 16. This filling level indicator line 18 consists of an upper line 34 and a lower line 36 located at a predetermined distance 38 from each other. Although the container 10 has been described in certain embodiments herein as a biological fluid collection container, such as a blood collection tube, and in particular a vacuum blood collection tube, it is believed that the embodiments of the invention may relate to any container for a biological sample.

[0017] The container 10 of figures 1-3 has an inner surface 20 and an outer surface 22. Blood, urine and / or other body fluids may be taken into the container assembly 10 for further testing procedures. The container 10 may include, for example, a glass or polymer composition such as polypropylene, nylon, polystyrene, cycloolefin copolymer, polyethylene terephthalate and / or polyethylene. The container may have any suitable length L and any suitable width W (or diameter) as intended. In one embodiment, the container 10 is a collection tube with an expected capacity of from about 1 to about 7 milliliters (ml), such as about 2.7 ml. In another embodiment, the container may have an expected capacity of about 1.8 ml.

[0018] The container 10 comprises a filling level line 18 formed integrally with the sidewall 16 that corresponds to the desired or expected sample filling capacity. In some embodiments, the desired sample fill capacity may include only the sample. In other embodiments, the desired characteristic capacity may include sample and additive. The expected fill volume can be defined as the volume of the biological fluid itself, such as blood entering the container, or the volume of the biological fluid plus an additive, such as a reagent. In other cases, the expected fill volume may include a volume of biological fluid plus a separator (gel or mechanical) and / or a volume of biological fluid plus a separator and additive.

[0019] The filling level indicator line 18 may indicate the desired minimum expected filling volume and may correspond to the meniscus of the liquid sample contained in the container assembly 10. The filling level indicator line 18 may be arranged continuously on the circumference of the container sidewall 10 or alternatively a filling level indicator line 18 may extend at least partially circumferentially around a portion of sidewall 16.

[0020] In the embodiments disclosed herein, the fill level indicator line 18 is an indication of the expected fill volume for the container

10 when the container 10 is placed vertically, in this case the position with the closure at the top. In this way, the volume indicator in the form of a filling line 18 serves as confirmation that the amount of sample inside the container 10 is the desired or expected filling volume of the container 10. Such a filling level indicator line 18 is particularly useful for sampling containers, e.g. to determine whether the amount of sample contained within the container corresponds to a predetermined collection volume for a particular collection container. In other embodiments, the volume indicator in the form of a fill line 18 is an indication of the desired or expected fill volume for the container when the container is placed in a non-vertical position. For example, blood collection containers typically have a vacuum or vacuum inside them. To clog the containers 10 and maintain the vacuum therein, a pierceable closure 24 is used. In use, the blood-collecting needle gains access to the patient's blood vessel and is in fluid communication with the interior of the blood-collecting container 10. Vacuum inside the container 10 draws a blood sample from the blood vessel, through the needle, into the collection container. Finally, the pressure inside the collection container 10 equalizes the blood pressure and at this point no further sample is drawn into the collection container. Accordingly, there may be a vacuum inside the collection container 10 to allow sufficient vacuum within the collection container

10, which will ensure that a predetermined volume of blood is drawn into the container as a result of the vacuum.

[0021] Furthermore, the sample containers 10 may contain specific reagents associated with the desired test to be carried out on the sample. One example of the reagent is citrate. The amount of reagent may be adjusted in particular to the specific expected sample filling volume for this container. If the amount of sample withdrawn into container 10 does not match the specified expected fill volume for the specimen sample and reagent, the reagent may not react properly with the sample, which may potentially lead to inaccurate test results. The fill level indicator line 18 provides a mechanism to help ensure that the correct volume of sample for reaction with the reagent is drawn into the container 10. For example, long-term storage of vacuum collection containers may reduce the vacuum therein, thereby limiting the volume drawn into the container 10. Furthermore, during the initial blood collection, air may enter the needle which passes into the first collection container used. Such air may reduce the total filling volume for container 10, in such a way that insufficient blood is drawn into the container relative to the reagent contained therein. By providing a filling level indicator line 18, the user can confirm immediately after blood collection that the correct amount of sample expected for that container 10 has actually been collected inside the container 10. In addition, by providing a line indicating the fill level 18 integral with the container itself, the expected fill volume is effectively set and is built directly into the container: without the possibility of a misalignment of the separate label identifying the intended or expected fill volume.

In yet another case, the filling level indicator line 18 can serve as confirmation for the laboratory technician whether the volume contained in the container 10 is the expected filling volume, in particular for a particular type of container. This indication can also be useful to confirm whether a sample has already been removed from the container 10 for analysis.

[0023] In one embodiment, the filling level line 18 indicates a part of the side wall 16 that has a different profile, surface, texture, etc. and is therefore adapted to diffuse the lights passing through the side wall 15 in a different way than for the rest of the side wall 16 defining the container 10.

[0024] The filling level indicator line 18 can be made by various techniques. For example, the line indicating the fill level 18 may include an edge protruding above the side wall 16 of the assembly, extending circumferentially around the container 10.

This edge may extend from the surface of the side wall 16. In another embodiment, the edge may be recessed into the side wall 16 to form a groove. The height of such an edge and / or the depth of such a groove may be of any desired size, as long as the dimensions of the protuberance and / or groove are a unique identifier for the human eye (or some other indicator), which makes it possible to distinguish the edge and / or groove from the side wall 16, representing the same line indicating the fill level. In another embodiment, the fill level indicator line 18 may include a colored band that differs from the color of the side wall 16. In such an embodiment, sidewall 16 may be a generally transparent material, with a separate colored dusted strip, patterned, or otherwise applied to the inner or outer surface of sidewall 16 to form a fill level indicator line 18.

[0025] Preferably, a filling level line 18 can be created in the injection molding process used to manufacture the container 10. In this type of process, the mold core member cooperates with the mold cavity and the plastic is injected into the cavity between the core and cavity to form a cylindrical member. The line indicating the fill level 18 is formed by providing a rough or textured surface at least partially extending around the perimeter of the core member. Therefore, during the molding process, this rough surface gives the characteristics of the inner surface of the sidewall 16 of the container 10. Providing the rough or textured surface of the core member, unlike the cavity member of the injection molding device, provides the advantage that it is easier to push the tube out of the core. If a textured or rough surface was provided in the cavity, as if the line indicating the fill level 18 had been applied to the outer surface of sidewall 16, there would be a risk that the tube would get stuck in the cavity. As stated above, it is easier to push the tube out of the core than to remove the tube from inside the cavity.

[0026] In yet another embodiment, the filling level line 18 may include a side wall area 16 that has been modified by surface treatment to give it a distinctive appearance and / or texture compared to the rest of the side wall 16. In such an embodiment, the area forming the fill level indicating line 18 may have translucent or opaque properties, and the remaining side wall 16 will have a high gloss transparent appearance. For example, sidewall area 16 defining a fill level indicator line 22 may be modified by EDM, etching or other similar process giving a textured appearance compared to the rest of sidewall 16. In one embodiment, a portion of sidewall 16 intended to define a level indicating line Filling 18 is rough to define the layout of the peaks and valleys. For example, the rough side wall portion can be produced in an erosion process to create an erosion finish. The finished part is then visually compared to a visual pattern, such as the visual surface pattern from Charmilles Technologies Company (Charmilles Technology Company, Lincolnshire, IL, USA). Using this standard practice, the rough surface defines a finish, for example, in the range 1.6 to 12.5 microns and more preferably, a finish in the range 4.5 to 12.5 microns. In addition, the rough surface can be visually compared to a pattern with a specific Charmilles finish number, such as between 24 and 42, and more preferably between 30 and 42. Such a surface provides a fill level indicator line 18 with a finish that is distinct from the rest of the side wall 16, such as a polished surface. Accordingly, the surface defining the fill level indicator line 18 diffuses the light differently than the rest of the side wall 16. In this way, when the liquid sample is contained in the container 10, a clear visual indication is observed when the sample is filled to the level line indicating the fill level 18, due to differences in the light diffused by the side wall 16. It is believed that certain types of finish of the filling level indicator line 18 may allow for a magnifying effect for the sample when the fluid level meniscus is near the filling level indicator line 18, which provides a visible indication of this level being reached.

[0027] The thickness or length of the line indicating the fill level 18 measured along the side wall 16 defining the length of the container 10 may take any desired value, provided that in one embodiment such length represents the appropriate volume range for a particular test when the fluid meniscus of the sample contained in container 10 is aligned with it.

[0028] Fig. 1 shows a fill level indicator line 18, where the fill level indicator line 18 consists of a single wide belt or the line 26 extends at least partially around the perimeter of the side wall part 16. The single belt 26 has a first predetermined width 28 defined by the upper limit 30 and the lower limit 32. The upper limit 30 defines the maximum expected fill volume. The lower limit 32 determines the minimum expected fill volume. A second predetermined width 28 defines the volume range for the expected filling volume of the collection container 10.

[0029] Fig. 2 shows a fill level indicator line 18 in accordance with an aspect of the invention, wherein the fill level indicator line 18 consists of an upper line 34 and a lower line 36 extending at least partially around the periphery around part of the side wall 16. The upper line 34 and bottom line 36 are positioned at a predetermined distance 38 from each other. The top line 34 specifies the maximum expected fill volume. Bottom line 36 defines the minimum expected fill volume. The predetermined distance 38 between upper 34 and lower line 36 defines the volume range of the expected filling volume of the collection container 10.

[0030] Fig. 3 shows a fill level indicator line 18, where the fill level indicator line 18 consists of a single thin line 40 extending at least partially around the circumference of the side wall 16. This single line 40 has a second predetermined width 42 corresponding to the minimum volume of the expected filling volume of the collection container.

[0031] As mentioned above, certain reagents may be included in the container 10. The line indicating the fill level 18 may therefore be associated with a specific volume of sample contained within the container for proper reaction with such a reagent. Accordingly, in embodiments of the invention, the container 10 may contain an additive, such as sodium citrate, tripotassium ethylenediaminetetraacetate (K3 EDTA), lithium heparin, etc., which can be added to the container 10 in liquid form, spray dried or in some other form.

[0032] As shown in Figs. 4-12, the container assembly 10 may include a dual tube-to-tube configuration. This type of configuration includes a first cylindrical member 44 including a first opening 46, a first closed bottom 48 and a first side wall 49 extending circumferentially between the first opening 46 and the first closed bottom 48. The first cylindrical member 44 may receive a sample of the formulation. The container further includes a second cylindrical member 52 comprising a second opening 54, a second closed bottom 56 and a second side wall 57 extending circumferentially between the second opening 54 and the second closed bottom 56. The first cylindrical member 44 is located within the second cylindrical member 52. A line an indication of the filling level 18 is placed on the second side wall. The fill level indicator line 18 consists of an upper line 34 and a lower line 36 placed at a predetermined distance 38 from each other. The first cylindrical member 44 or, in this case, the inner tube 42, has an axis length less than the length of the second cylindrical member 52 or the outer tube. As a result, a closure 24 may be provided on the upper portion of the container assembly to provide a sealing connection with parts of both the first and second cylindrical members - 44, 52. The outer surface 51 of the first cylindrical member 44 and the inner surface 58 of the second cylindrical member 52 can be dimensioned so that they are substantially nested therein and can be constructed to prevent foreign substances (such as a biological sample) from entering the space that can between the inner surface 58 of the second cylindrical member 52 and the outer surface 51 of the first cylindrical member 44. This "tube-in-tube" configuration is described in detail in U.S. Patent No. 6,910,597 (Spark).

[0033] In the "tube-in-tube" configuration, different materials can be used for each tube, for example, one tube may contain glass, and another tube may contain a polymer composition for better liquid and vapor resistance. Alternatively, both tubes can be made from a polymer composition in which one of the nested containers can be made of a material that, for example, exhibits desirable gas barrier properties, and the other of the containers can be made of a material that, for example, forms a moisture barrier. The inner container is made of a material that has the right surface for the specific clinical behavior of the material stored in the container assembly. Materials exhibiting desirable gas barrier properties include: acrylic polymers and copolymers, including acrylonitrile-butadiene-styrene (ABS), styrene-acrylonitrile (SAN); ethylene vinyl alcohol (EVA); polyesters; polyethylene terephthalate (PET); glycol modified (polyethylene terephthalate) (PETG); poly (ethylene terephthalate) - naphthalene (PETN); polyethylene naphthalate (PEN); and modified thermoplastic polymers, including polycarbonate and mixtures thereof. Materials exhibiting desirable moisture or vapor barrier properties include: polyolefins, including polyethylene, polypropylene and their copolymers, cyclic olefin copolymers, and chloro- and fluoropolymers, including poly (vinylidene chloride) (PVDC), poly (vinylidene fluoride) (PVDF ), poly (vinyl fluoride) (PVF) and chlorotrifluoroethylene (CTFE or ACLAR). In one embodiment, the inner or first cylindrical member 44 is formed of polypropylene (PP) and the outer or second cylindrical member 52 is formed of PET.

[0034] The first and second cylindrical members - 44, 52 - can be manufactured separately, such as by injection molding, as discussed in detail above, and then combined. Alternatively, the cylindrical members can be double extruded.

[0035] According to a first embodiment, as shown in Figs. 4-6, a filling level indicator line 18 may be formed on the inner surface 58 of the second or outer cylindrical member 52. Fig. 4 is a line indicating the fill level as an indicator in the form of a wide strip 26, the indicator 26 being formed integrally with the inner surface 58 of the second cylindrical member 52 having a first predetermined width 28 defining the range of the expected filling volume for this container. FIG. 5 is a line indicating the fill level as top line 34 and bottom line 36, according to an aspect of the invention, the lines being formed integrally with the inner surface 58 of the second cylindrical member to determine the volume range 38 showing the expected filling volume of the container 10. Fig. 6 is a line indicating the fill level in the form of a single thin line 40, the line 40 being located on the inner surface 58 of the second cylindrical member 52. This single thin line 40 has a second predetermined width 42 indicating the minimum expected fill line for this container. As discussed in detail above, it is preferable to place this line indicating the fill level on the inner surface of the tube during injection molding, as it is easier to process and remove the formed tube having the indicator applied. It is also advantageous to place a line indicating the fill level on the outer tube when using, for example, an outer tube made of polyethylene terephthalate, because the matting of this fill line allows for greater contrast for this type of material than for the inner tube, such as when this type of tube is made of polypropylene material.

[0036] It is further believed that such "tube-in-tube" container configurations may further include an outer rough or textured surface on the inner tube to allow air to escape from the space between the containers during assembly of the inner tube in the center of the outer tube, e.g. an enlarged textured gable portion shown and described in the above-mentioned US Patent No. 6,910,597. Such a rough or textured surface on the enlarged top of the inner tube is distinct and different from the textured surface representing a fill level indicator line, such as fill level indicator lines 26, 34, 36, 40, which also represents a rough or textured surface, but it is distant from the top of the inner tube and is directly related to the fill volume of the container and is not intended to function as part of the assembly allowing air to escape. The location of the indicator is also in relation to the desired uptake volume (blood) and amount of reagent, the amount of reagent being selected for a given uptake volume, and the location of the fill level line 18 correlating with the uptake volume and reagent amount.

[0037] According to a second embodiment, as shown in Figs. 7-9, a filling level line 18 may be formed on the inner surface 50 of the first or inner cylindrical member 44. Fig. 7 is a line indicating the level of filling as an indicator in the form of a wide strip 26 in accordance with the first aspect of the invention, the indicator 26 being formed integrally with the inner surface 50 of the first cylindrical member 44 having a first predetermined width 28 defining the range of the expected filling volume for this container. FIG. 8 is a line indicating the fill level in the form of an upper line 34 and a lower line 36 according to the invention, these lines being formed integrally with the inner surface 50 of the first cylindrical member 44 defining a volume range 38 showing the expected filling volume for the container 10. Fig. 9 is a line indicating the fill level in the form of a single thin line 40, in accordance with the third aspect of the invention, the line being placed integrally with the inner surface 50 of the first cylindrical member 44. The single thin line 40 has a second predetermined width 42 showing the minimum expected fill line for this container.

[0038] According to the third embodiment, as shown in Figs. 10-12, a line indicating the fill level 18 may be formed on the outer surface 51 of the first or inner cylindrical member 44. Fig. 10 is a line indicating the fill level as an indicator in the form of a wide strip 26, the indicator 26 being integrally formed with the outer surface 51 of the first cylindrical member 44 having a first predetermined width 28 defining the range of the expected filling volume for this container. FIG. 11 is a line indicating the fill level in the form of an upper line 34 and a lower line 36, these lines being integrally formed with the outer surface 51 of the first cylindrical member 44 defining a volume range 38 showing the expected filling volume of the container 10. Fig. 12 is a line indicating the fill level in the form of a single thin line 40, the line being integrally with the outer surface 50 of the first cylindrical member 44. The single thin line 40 has a second predetermined width 42 showing the minimum expected fill line for this container.

[0039] As shown in Figures 13-15, a filling level line 18 can be used with other types of containers in addition to the "tube-in-tube" configuration. For example, a fill level indicator line 18 can be used with a single cylindrical member 60. As shown in Fig. 13, a fill level indicator line 18 may be formed on the inner surface 61 of the cylindrical member 60 as an indicator in the form of a wide strip 26, the indicator 26 being formed integrally with the inner surface 61 of the cylindrical member 60 and the indicator having a first predetermined width 28 defining the range of the expected fill volume for this container. FIG. 14 is a line indicating the fill level in the form of an upper line 34 and a lower line 36, in accordance with an aspect of the invention, the lines being formed integrally with the inner surface 61 of the cylindrical member 60 defining a volume range 38 showing the expected filling volume of the container 10. Fig. 15 is a line indicating the fill level in the form of a single thin line 40, the line 40 being located on the inner surface 61 of the cylindrical member 60. The single thin line 40 has a second predetermined width 42 showing the minimum expected fill line for this container.

[0040] Although the embodiments discussed previously were for cylindrical containers with a closed end, the filling level line 18 can be used on tubes open from two sides, such as shown in Fig. 16. In this embodiment, the container assembly includes a cylindrical member comprising a first end 70, second end 72 and sidewall 74 extending circumferentially between first end 70 and second end 72. The filling level indicator line 18 consists of an upper line 34 and a lower line 36 placed at a predetermined distance 38 from each other. First end 70 and second end 72 may be closed by closures 24. Although Fig. 16 shows a fill level indicator line 26, the fill level indicator line 18 may include any of the fill level indicator line designs 26, 32, 34, 40.

[0041] Although specific embodiments of the invention have been described in detail, one of ordinary skill in the art will recognize in the light of the overall disclosure contained herein that various modifications and alternatives to the details disclosed may be developed. For example, while the filling lines have been described above in such a way that they are parallel to the circumference of the open end of the container or container assembly, the filling lines may be placed on the container or assembly at an angle so that the volume of the sample can be recognized when the container or the band are at an angle. Additionally, while the filling lines described above are positioned in such a way that they extend around the entire perimeter of the container or assembly, in some embodiments, the filling line (s) may (may) surround only a portion of the container or assembly and / or may be placed in segments (e.g. in the form of dashed lines). In addition, while in the embodiments the inclusion of a fill line on a container or set of one or more tubes is described, one or more of the described fill line elements may be used in additional types of container structures (such as sampling bags).

Becton, Dickinson and Company, USA

PROXY:

EP 2110174

Z-12047/14