Title of Invention

"SYSTEM OF CONTAINERS FOR COLLECTING A BODILY FLUID SAMPLE"

Abstract

A plurality of container assemblies are provided. Each container assembly has substantially identical external dimensions. However, the internal volumes of certain container assemblies differ from the internal volumes of other container assemblies. The container assemblies are configured in accordance with the required volume of material to be collected or maintained in the respective container assemblies and to enable uniform head spaces despite the different volumes of materials in the respective container assemblies. Each container assembly may have an inner container and an outer container. The inner and outer containers may be assembled together or formed integrally by molding.

Full Text

1. Field of the Invention The invention relates to a system of containers for collecting a bodily fluid sample. 2. Description of the Related Art Tubes are used to collect specimens or samples of bodily fluid. The typical tube includes a cylindrical sidewall with a spherically generated closed bottom and an open top. A closure is mounted to the open top to permit sealing of the tube. The closure typically comprises an elastomeric stopper that is urged into the open top of the tube. The closure also may include a rigid plastic member that retains the elastomeric stopper. The plastic member can be used to manipulate the stopper for placing the closure in the open top of the tube or for removing the closure from the tube. The elastomeric stopper may be formed from a pierceabie and resealable material. Some closures also include a layer of foil across the top of the closure for enhanced performance of the closure as a gas or moisture barrier. Tubes typically are formed from either glass or plastic. Glass tubes perform well as gas and moisture barriers, but are more fragile than plastic tubes. Hence, glass tubes may require special handling. Plastic tubes are substantially unbreakable. However, certain plastics may be permeable to gases or moisture. A sample of fluid collected in a tube typically is sent to a laboratory for analysis. Characteristics of the collected sample may change if the sample is exposed to ambient gases or if vapors produced by the sample are permitted to permeate through the walls of the tube and into the ambient surroundings. Characteristics of the collected sample also may vary after exposure to gas trapped between the surface of the collected fluid sample and the stopper. The volume between the top of the collected sample and the stopper is referred to herein as the head space. Most laboratory analysis of collected fluid samples are performed with automated or semi-automated equipment. The equipment typically is geared to accommodate tubes of specified outside dimensions. Tubes that are too small may require separate handling, and hence tubes with non-standard outside dimensions may require slower less efficient and more costly analysis of the specimens collected therein. Accordingly, most health care facilities collect specimens in standard sized tubes. However, some tests can be performed with relatively small volumes of a fluid sample. A collection of a small volume sample in a relatively large tube necessarily creates a large head space with a large volume of air above the collected sample. Accordingly, there is a greater probability that characteristics of a small collected sample will vary prior to testing due to interaction or reaction with the relatively large volume of air in the head space. It is desirable to provide a tube with standard outside dimensions. It is also desirable to collect only the smallest volume of a sample that is required for a particular laboratory analysis. Furthermore, it is desirable to provide a smaller and substantially uniform head space. SUMMARY OF THE INVENTION The subject invention is directed to sample collection containers. The sample collection containers have selected outside dimensions to conform with instruments and equipment employed in a laboratory. The sample containers, however, have wall dimensions selected to achieve a small and uniform head space between the top of the collected sample and the bottom of the closure. The container may be a tube with a substantially cylindrical outer surface. The bottom of the tube may be closed and may have a substantially spherically generated outer surface. The top of the tube is open. The walls of the container may be of different thicknesses at various locations between the closed bottom of the container and the open top. For example, walls of the container adjacent the open top may have a thickness selected in accordance with strength requirements of the container and/or in accordance with standard dimensions for the closure. The walls of the container spaced from the open top, however, may have a thickness greater than the thickness of the container at the open top. The greater thickness of the container walls at locations spaced from the open top function to reduce the volume of the space in the container. Thus, a small volume of a fluid sample can be collected without significantly increasing the head space and achieving a desirably low sample to head space volume ratio. The collection container may be formed from a plastic material by a molding process, such as co-injection, two-shot molding or other known process to provide an integral or unitary matrix of plastic between inner and outer surfaces of the container. Alternatively, the collection container may comprise a plurality of nested containers. The nested containers may comprise an outer container of substantially uniform wall thickness and an inner container with a variable wall thickness. The inner container can be slidably inserted into the outer container so that the two containers function as a single container assembly. The variable thickness of the inner container may comprise a thin wall portion adjacent the open top of the inner container and a thick wall portion adjacent the bottom of the inner container. The thickness of the thick wall section of the inner container is selected to achieve a small head space that can be uniform for a range of collected specimens of a particular type and a particular volume. The thin wall section of the inner container may be dimensioned for engagement by at least part of the closure. The outer surface of the inner container and/or the inner surface of the outer container may be formed with surface configurations to facilitate nesting of the two containers. The surface configurations can include a roughening along at least a portion of the outer surface of the inner container or the inner surface of the outer container. The roughening defines an array of peaks and valleys, and air that would otherwise be trapped between the containers can escape through the valleys as the containers are being assembled. Hence, an air lock is not likely to be created as the inner and outer containers are assembled. Furthermore, compressed air will not exist in the minute spaces defined between the inner and outer containers, and accordingly migration of air through the inner wall of the inner container is substantially reduced or eliminated. The invention also is directed to a system of containers. All of the containers in the system have uniform outside shapes and dimensions. However, the wall thicknesses of the containers vary among groups of containers within the system. As a result, the volume of fluid that can be collected by the containers in the system varies among at least certain of the containers. The volume is inversely related to the thickness of the walls of the containers All of the containers within the system, however, provide a substantially uniform head space. DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of a tubular container in accordance with the subject invention. FIG. 2 is a perspective view of the container shown in FIG. 1. FIG. 3 is a top plan view of the container show in FIGS. 1 and 2. FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 3. FIG. 5 is a longitudinal cross-sectional view of a second embodiment of a container assembly in accordance with the subject invention. FIG. 6 is an exploded perspective view of the container of FIG. 5. FIG. 7 is a longitudinal cross-sectional view of a third embodiment of a container assembly in accordance with the subject invention. FIG. 8 is a longitudinal cross-sectional view of a fourth embodiment of a container assembly in accordance with the subject invention. FIG. 9 is a longitudinal cross-sectional view of a fifth embodiment of a container assembly in accordance with the subject invention. FIG. 10 is a longitudinal cross-sectional view of a sixth embodiment of a container assembly in accordance with the invention. DETAILED DESCRIPTION A container in accordance with the subject invention is identified generally by the numeral 10 in FIGS. 1-4. Container 10 includes a generally tubular sidewall 12, a closed bottom 14 and an open top 16. Tubular sidewall 12 includes a cylindrically generated outer surface 18 defining a diameter "a" as shown in FIG. 1. Closed bottom 14 of container 10 has a substantially spherically generated outer surface 20 characterized by a concave dimple 22 centrally disposed on the closed bottom. Tubular sidewall 12 of container 10 is further characterized by an inner surface 24 of substantially stepped cylindrical configuration. In particular, inner surface 24 includes a cross-sectionally small section 26 adjacent bottom end 14 of contamer 10 and a cross-sectionally large section 28 adjacent open top 16. Cross-sectionally small section 26 has an inside diameter "b" as shown in FIG. 4, while cross-sectionally large section 28 has an inside diameter "c". Inside diameter "c" at cross-sectionally large section 28 is dimensioned to achieve tight engagement with a closure (not shown in FIGS. 1-4). Container 10 is molded unitarily from a plastic material by a molding process. The stepped inside surface 24 of container 10 enables a small volume of fluid to be collected without altering outside dimensions of container 10. Thus, outside diameter "a" enables container 10 to be used with standardized laboratory equipment. However, the stepped cylindrical inner surface 24 enables a small volume of fluid to be collected in container 10 without an undesirably large head space. Container 10 may have a sidewall 12 and a bottom wall 14 with thicknesses dimensioned to achieve a volume ranging from about 1 mL to about 4 mL. Fluid samples of these volumes are acceptable for many testing procedures and enable a head space in the range of 5-16 mm (i.e.. 0.8-1.5 mL) to be achieved. Tubes of similar construction but with different wall thicknesses and different inside diameters for inner surface 24 can be used to achieve different fluid volumes without significantly affecting the head space. Container 10 can be used with a closure, such as an eiastomeric stopper inserted into open top 16. The stopper may function to maintain a vacuum in container 10 so that container 10 can be used for drawing a sample of blood. The embodiment of the invention depicted in FIGS. 1-4 shows tube 10 formed from plastic material by a co-injection process or other molding process familiar to those in the art. For example, an outer portion of tube 10 may be molded from a first plastic and an inner portion may be molded from a second plastic. The co-injection or other molding process achieves an integral or unitary matrix of plastic between inner and outer surfaces 24 and 18. The plastics selected for the inner and outer portions of tube 10 are selected in accordance with specific requirements, such as compatibility with the stored material, liquid impermeability, gas impermeability and such. FIGS. 5-8 show an alternate embodiment where tube assemblies comprise inner and outer tubes. In particular, FIGS. 5 and 6 show a tube assembly 40 with an outer container 42 and an inner container 44. Outer container 42 includes a substantially cylindrical tubular sidewall 46, a closed bottom 48 and an open top 50. Tubular sidewall 46 includes a cylindrically generated outer surface 52 and a cylindrically generated inner surface 54. Outer surface 52 and inner surface 54 of outer tube 42 are of substantially uniform cross-section along the entire length of tubular sidewall 46. Thus, tubular sidewall 46 is of substantially uniform thickness along its length. Inner tube 44 includes a tubular sidewall 56, a closed bottom 58 and an open top 60. Tubular sidewall 56 has an outer surface 62 and an opposed inner surface 64. A roughened region that defines an array of peaks„and valleys extends along at least a portion of the outer surface 62, as shown most clearly in FIG. 6. The diameter defined by the peaks on outer surface 62 of tubular sidewall 56 substantially equals the inside diameter of inner surface 54 on sidewall 46 of outer tube 42. The valleys between the peaks on the roughened outer surface 62 define an outside diameter that is less than the inside diameter of inner surface 54 of sidewall 46 on outer tube 42. The valleys on roughened outer surface 62 define circuitous or tortuous paths that permit an escape of air A as inner tube 44 is being inserted into outer tube 42. Thus, assembly of tubes 42 and 44 is easier and there is no build-up of high pressure air between inner and outer tubes 42 and 44. Inner surface 64 of inner tube 44 has a substantially cylindrical portion 66 extending up from closed bottom 58 and an outwardly tapered portion 68 adjacent open top 60. Cylindrical portion 66 of inner surface 64 defines an inside diameter "d". Inside diameter "d" is selected to achieve a preferred volume for tube assembly 40. In the illustrated example of FIG. 5, tube assembly 40 accommodates 3.5 ml. Tube assembly 40 is employed with a closure 70 to seal inner tube 44 and outer tube 42 adjacent the respective open tops 60 and 50, and in some embodiments to maintain a low pressure. Thus, a selected volume of blood can be collected in tube assembly 40 by placing the evacuated interior of tube assembly 40 in communication with a blood vessel. This communication can be achieved with a conventional needle holder, a blood collection set or other known means. In the illustrated example, closure enables the 3.5 mL fluid sample to be collected, while retaining a head space of approximately 5-16 mm (i.e., 0.8-1.5 mL). FIG. 7 illustrates a tube assembly 80 that is similar to tube assembly 40. In particular, tube assembly 80 includes an outer tube 42 identical to outer tube 42 described above with respect to FIG. 5. Tube assembly 80 farther includes an inner tube 84 that is similar to inner tube 44 of tube assembly 40. In particular, inner tube 84 has a tubular sidewall 86, a closed bottom 88 and an open top 90. Tubular sidewall 86 has an outer surface 92 that may be substantially identical to the outer surface 62 of inner tube 40. Inner tube 84 further includes an inner surface 94 with a cylindrically generated section 96 adjacent closed bottom 84 and an outwardly tapered section 98 adjacent open top 90. Cylindrically generated section 96 of inner surface 94 defines an inside diameter "e" that is less than inside diameter "d" of cylindrical portion 66 on inner surface 64 of inner tube 44. As a result, lube assembly 70 can accommodate a volume of about 3.0 mL while achieving a head space of 5-16 mm (i.e., 0.8-1.5 mL) substantially equal to the head space achieved with tube assembly 40. FIG. 8 shows a tube assembly 100 with an outer tube 42 substantially identical to outer tube 42 of tube assemblies 40 and 80. Tube assembly 100 also includes an inner tube 104 that has a tubular sidewall 106, a closed bottom 108 and an open top 110. Tubular sidewall 106 has an outer surface 112 that may be substantially identical to outer surface 62 of sidewall 56 on inner tube 44. Tubular sidewall 106 further has an inner surface 114 with a cylindrically generated section 116 adjacent closed bottom 108 and an outwardly flared section 118 adjacent open top 110. Cylindrically generated section 116 of inner surface 114 defines an inside diameter "f' that is less than inside diameter "e" of inner tube 84. As a result, tube assembly 100 can accommodate a fluid sample of only about 2.0 ml, while achieving a head space of 5-16 mm (i.e., 8-1.5 mL) substantially equal to the head spaces of the tube assemblies 40 and 80. The system of tubes depicted in FIGS. 5-8 enables collection of a fluid sample of appropriate size for a particular laboratory test to be performed, but without affecting the head space. The reduced volume and substantially uniform head space can be achieved by providing an effectively thicker bottom wall as shown in FIG. 9 instead of or in addition to the variable thickness of the sidewalls. In particular, FIG. 9 shows a tube assembly 120 with an outer tube 42 substantially identical to the outer tube 42 shown in FIGS. 5-8. Additionally, tube assembly 120 includes a closure 70 that may be substantially identical to the closures shown in FIGS. 5-8. Tube assembly 120 further includes an inner tube 124 with a projection 126 at the closed bottom end thereof. As a result, a raised bottom wall 128 is spaced considerably above closed bottom 48 of outer tube 42. Accordingly, inner tube 124 defines a smaller volume than inner tube 44 in the embodiment of FIGS. 5 and 6 without an increase in wall thickness. Furthermore, the projection 126 enables the closed bottom of inner tube 124 to be raised without a significant increase in thickness of inner tube 124. In this latter regard, a significantly increased thickness at the bottom of inner tube 124 could complicate molding. The container of the subject invention may include closures that extend greater distances into the container for reducing the head space and achieving a substantially uniform head space for different volumes of fluid. In particular, FIG. 10 shows a container assembly 130 with an outer tube 42 substantially identical to the outer tube of the embodiments shown in FIGS. 5-9. Assembly 130 further includes an inner tube 134 that is very similar to inner tube 44 in the embodiment of FIGS. 5 and 6. However, inner tube 134 is shorter than inner tube 44. Tube assembly 130 further includes a closure 170 that is similar to closure 70 on the embodiments of FIGS. 5-9. However, closure 170 includes an internal section 172 with a length "h" that exceeds the corresponding length of closure 70 shown in the embodiments of FIGS. 5-9. The greater length "h" compensates for the shorter length of inner tube 134 and effectively reduces both the volume of tube assembly 134 and the head space. The different length closures 170 can be used with or instead of the different effective thicknesses for the bottom wall (FIG. 9) and/or the different thicknesses for the sidewalls (FIGS. 5-8). We claim: 1. A system of containers (40; 80; 100; 120) comprising at least a first container assembly (40; 80; 100) and a second container assembly (80; 100; 120), each of said container assemblies in said system having an outer container (42) and an inner container (44; 84; 104; 124) nested within said outer container (42), each said container assembly comprising a closure (70), such that closures (70) of said first and second container assemblies are identical, characterized in that said outer container (42) of each of said container assemblies have identical external dimensions, said inner container (44; 84; 104) of said first container assembly (40; 80; 100) being configured to define a first volume for said first container assembly, said inner container (84; 104; 124) of said second container assembly (80; 100; 120) being configured to define a second volume for said second container assembly (80; 100; 120), such that said second volume is less than said first volume, whereby said first and second container assemblies (40; 80; 100) (80; 100; 120) enable collection of different volumes of a fluid with identical head spaces in the respective container assembly. 2. The system of containers as claimed in Claim 1, wherein the inner container (44; 84) of the first container assembly (40; 80) has a sidewall (46; 86) with a first thickness, the inner container (84; 104) of the second container assembly (80; 100) having a sidewall (86; 106) of a second thickness, the second thickness being greater than the first thickness. 3. The system of containers as claimed in Claim 1, wherein the outer container (42) of each said container assembly (80)(120) has a closed bottom (48) and an open top (50), the inner container (84)(124) of each said container assembly having a bottom wall (88) (128) at least partly nested with the closed bottom of the outer container (42) of the respective container assembly, the bottom wall (88) of the inner container (84) of the first container assembly (80) being spaced a first distance from the open top of the outer container (42) of the first container assembly, the bottom wall (128) of the inner container (124) of the second container assembly (120) being spaced a second distance from the open top of the outer container (42) thereof, the second distance being less than the first distance. 4. The system of containers as claimed in Claim 3, wherein the bottom wall (128) of the inner container (124) of the second container assembly (120) comprises a projection (126) extending into nested engagement with the closed bottom (48) of the outer container (42) of the second container assembly (120). 5. The system of containers as claimed in claim 4 wherein said projection raises the closed bottom of the inner container (124) of the second container assembly (120) and the thickness of said closed bottom is equal to thicknesses existing at other locations on said inner container. 6. The system of containers as claimed in Claim 1, wherein the inner container (44) of the first container assembly (40) has a closed bottom (48) and an open top (50) and defining a first length therebetween, the inner container (134) of the second container assembly (130) having a closed bottom and an open top and defining a second length therebetween, the second length being less than the first length. 7. The system of containers as claimed in Claim 6, wherein the first container assembly (40) has a first closure (70) and the second container assembly (130) has a second closure (170), the first and second closures (70; 170) extending into sealing engagement with the open tops of the inner containers in the respective first and second container assemblies, such that said first and second closures extend a first and second distance into the open tops of the respective container assemblies, and said second distance is greater than said first distance, the container assembly with said second closure defining an inner volume smaller than the container with the first closure. 8. The system of containers as claimed in Claim 1, wherein the inner container of each of said container assemblies has a plurality of surface of discontinuities (62) for permitting an escape of air as the inner container (44) is nested into the outer container (42) of the respective container assembly. 9. The system of containers as claimed in Claim 1, wherein the outer container (42) of each said container assembly is a tube with a cylindrical sidewall. 10. The system of containers as claimed in Claim 9, wherein the inner container (44) of each said container assembly (40) is a tube with a cylindrical sidewall (66), inner surface regions (68) of each said inner container (44) defining an outwardly tapering open top (60) for sealing engagement with a closure (70). 11. The system of containers as claimed in claim 1, wherein said container assemblies are molded unitarily of plastic. 12. The system of containers as claimed in claim 1, wherein the outer container (42) of each said container assembly is formed from a first material and wherein the inner container (44) of each said container assembly is formed from a second material different from said first material, said first and second materials of the kind such as herein described. 13. The system of containers as claimed in any preceding claim, wherein said container assemblies is an evacuated container in communication with a source of the fluid. 14. The system of containers as claimed in any preceding claim, for collecting a required volume of bodily fluid sample.

Documents:

753-delnp-2005-abstract.pdf

753-DELNP-2005-Claims.pdf

753-delnp-2005-complete specification (as,files).pdf

753-delnp-2005-complete specification (granted).pdf

753-DELNP-2005-Correspondence-Others.pdf

753-delnp-2005-correspondence-po.pdf

753-DELNP-2005-Description (Complete).pdf

753-delnp-2005-drawings.pdf

753-DELNP-2005-Form-1.pdf

753-delnp-2005-form-13.pdf

753-delnp-2005-form-18.pdf

753-DELNP-2005-Form-2.pdf

753-delnp-2005-form-3.pdf

753-delnp-2005-form-5.pdf

753-delnp-2005-gpa.pdf

753-delnp-2005-pct-210.pdf

753-delnp-2005-pct-304.pdf

753-delnp-2005-petition-137.pdf

753-delnp-2005-petition-138.pdf

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