MXPA98006919A - Container unit for recolecc - Google Patents

Abstract

The present invention is a collection container unit consisting of a container with a false bottom having a rounded open end and wherein the external dimensions of the container are substantially the same as those of a normal-sized blood collection tube , but with a reduced internal volume

Description

UNIT 'OF RECIPIENT FOR COLLECTION BACKGROUND OF THE INVENTION 1. FIELD OF THE INVENTION This invention relates to a container unit for the collection of samples and, more specifically, to a collection container for collecting samples of biological fluids where a small amount of fluid can be collected and maintained in the container while maintaining a sufficient container size to be easily accommodated and / or compatible with standard clinical equipment and instruments. 2. Description of the Related Art Blood samples and other samples of biological fluid are routinely taken and analyzed in hospitals and clinical situations for various medical purposes. The collection, handling, and testing of these samples usually require the use of various medical testing instruments. Because blood and fluid samples are usually collected in a normal-sized collection tube, the medical instruments used to perform the sample tests are designed to accommodate these normal size collection tubes.

Conventional blood collection tubes which are used in most clinical situations are elongated cylindrical vessels having one end closed by a semi-spherical or rounded portion and an opposite open end. The open end can be sealed by a resilient cap or plug. The tube defines an interior for the collection that collects and maintains the blood sample. The most common size of these blood collection tubes is designed to contain approximately 10 ml of blood fluid samples or other biological fluid. An example of these tubes for blood collection is the VACUTAINER® blood collection tube marketed by Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ (trademark of Becton, Dickinson and Company). A phlebotomist or other medical technician usually obtains a sample of the patient's blood in the tube by well-known techniques. The tube is then properly marked and transferred from the collection site to a laboratory or to another place where the contents of the tube are analyzed. During the collection and analysis the tube can be supported by various medical instruments. The plasma or serum obtained from it is processed and analyzed manually, semiautomatically or automatically. In some cases, the sample must first be dosed from the collection tube to a tube or cuvette for sample testing. Sometimes it is only necessary to obtain a small amount of blood samples or other biological fluids. These situations may include pediatric or geriatric patients and other cases where large blood samples are not required. Small amounts of blood can not be easily collected in normal collection tubes as described above because the level of the sample in these containers would not be adequate for recovery before analysis. These small amounts of fluids also have a tendency to evaporate significantly when stored in larger containers, thus concentrating the chemical and enzymatic substituents in these. This can give rise to erroneous analytical results and may possibly affect the diagnosis and treatment given to the patient. Therefore, it is desirable to employ small volume containers that substantially avoid evaporation during storage and dosing of small fluid samples in the laboratory. Although various fluid containers are available for this purpose, their small size and overall shape make it difficult for the phlebotomist or other medical technician to handle and manipulate the tubes. In addition, these small dimension tubes are generally incompatible with most test handling and instrumentation. For example, its use in conventional storage racks or supports designed to load on automatic chemical analyzers is substantially impossible due to its small dimensions. Certain automated chemical analyzers may use standard sample containers, standardized as a means of introducing a patient sample into the analyzer. However, these are generally not equipped to handle sample containers designed to contain small amounts of fluid. In addition, since labels placed on most blood collection tubes are read by optical instrumentation such as bar code readers, conventional bar code labels may be too large to be supported on small volume tubes. Various sample containers, such as those incorporating a "false base", have been proposed to reduce the capacity of the volume together with the standard external dimensions. However, these various sample containers are not compatible with standard clinical equipment and instrumentation due to their design. In particular, these sample containers have false bottoms with a generally flat bottom end and a circular hole. In clinical use it is desirable for these containers to collect samples that have round bottom configurations that closely simulate a tube configuration for normal-sized blood collection rather than flat bottoms. The rounded background configurations facilitates compatibility with clinical equipment and instrumentation. Therefore, there is a need to provide a container unit for the collection of samples to collect blood samples and other samples of biological fluid of relatively small volumes where the unit can be accommodated and / or compatible with the equipment and / or standard clinical instrumentation and where the integrity of the sample and specimens is maintained during storage and transport.

SUMMARY OF THE INVENTION The present invention is a collection unit comprising a container. The container preferably contains an open upper portion, a lower base portion and a side wall extending from the open upper portion to the base portion lower. The lower base portion contains a closed base end or real base and an annular skirt extending from the closed base end to a rounded end end. The annular skirt provides a false bottom effect for the unit and the rounded end end provides a means 5 to allow the container to be compatible with the equipment and normal clinical instrumentation. The actual end may be of the same material or H different than the container and may be integrated with the container or may be a discontinuous member. In addition, the The actual end may be arcuate in shape to provide an internal volume for the collection of the samples with at least a real partially rounded base portion, or it may be conical in shape. Otherwise, the annular skirt may extend from the closed base end to a second fully rounded closed base end or may contain a cap or stopper, preferably, the outer dimensions of the container are approximately the same as a container unit for collection of blood for extraction full or standard size. A normal size blood collection vessel unit has an external diameter of about 13 to about 16 millimeters, a length of about 75 to about 100 millimeters and an internal volume of about 6 to about 10 milliliters.

More preferably, the unit of the present invention can be vacuum or not vacuum. It is desirable that the unit be made of thermoplastic polymers. More preferably, the unit is made of polyethylene terephthalate, polypropylene, polyethylene, polyethylene naphthalate or copolymers thereof. An advantage of the unit of the present invention '? is that it provides a container unit for the collection of completely extracted blood that has a internal volume reduced but with external dimensions approximately equal to a unit of container for blood collection, standard size. Another advantage of the unit of the present invention is that it provides a container for the collection of 15 samples that is universally compatible with the different equipment and clinical instrumentation. In particular, the unit of the present invention does not require any external adapters and the like attached to the unit to be compatible with the different equipment and clinical instrumentation. The unit of the present invention can be easily handled by the equipment configured to handle normal size blood collection tubes having normal external dimensions. More importantly, the unit of the present invention provides a container for collecting blood that has external dimensions for extraction to the total, but with a reduced internal volume compared to the tubes for blood collection, for extraction up to the total, of normal size. The unit of the present invention therefore considers the need for a blood collection vessel unit, of small volume, of size for | B extraction up to the total, which presents the external dimensions of a tube for blood collection, of size normal. The unit of the present invention can be used to reliably collect small samples of blood or biological fluids and to maintain the integrity of the samples during storage and storage. transport compared to the use of normal size blood collection tubes. In addition, the unit of the present invention can also be housed by equipment for normal size blood collection, transportation, storage and diagnostics. Most notably, the unit of the present invention provides a round base configuration that closely simulates a normal-sized blood collection tube with a completely round base. This specific feature along with all the characteristics of the container distinguishes it from sample containers that have flat bottoms. The unit of the present invention is also compatible with the existing instrumentation, labels and barcode readers and avoids the need for new instruments and handling devices or procedures that would be necessary for tubes of different size or smaller size or tubes with a bottom flat .

DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of the false bottom sample tube of the prior art. Figure 2 is a longitudinal sectional view of the tube of Figure 1 taken along line 2-2 thereof. Figure 3 is a perspective view of the unit of the present invention. Figure 4 is a longitudinal sectional view of the unit of Figure 3 taken along line 4-4 thereof. Figure 5 is a perspective view of an alternative embodiment of the present invention. Figure 6 is a perspective view of an alternative embodiment of the present invention.

DETAILED DESCRIPTION The present invention may be incorporated in other specific forms and is not limited to any specific modality described in detail that is merely exemplary. Various other modifications will be apparent and will be readily made by those skilled in the art without departing from the spirit and scope of the invention. The scope of the invention will be measured by the appended claims and their equivalents. With reference to the drawings in which the reference characters refer to parts in all the various views thereof, Figures 1 and 2 show a sample container with false bottom 10 of the prior art having a side wall 12 with an outer surface 14 and an inner surface 16. The side wall 12 extends from the upper portion 18 to the lower wall 20. The upper portion 18 includes an open end 22 and a flange 24. The lower portion 20 consists of a closed base end 26. An annular skirt 28 extends from the lower portion 20 and the outer surface 14 to a flat base end 30 to define a false bottom 32. The inner volume 34 extends between the flange 24 and the closed base end 26 With regard to the drawings in which the same reference characters refer to equal parts in all the different views of the same, Figures 3 and 4 show the pref mode of the present invention, the unit 50. The unit 50 is a sample container with a false bottom having a side wall 62 with an external surface 64 and an internal surface 66. The side wall 66 extends from the upper portion 68 to the lower portion 70. The upper portion 68 includes an open end 72 and a flange 74. The lower portion 70 contains a closed base end or actual base 76. An annular skirt 78 extends from the lower portion 70 and the outer surface 64 up an open base end or false bottom end 80 to define an open false bottom area 82. The inner volume 84 extends between the flange 74 and the closed base end 76. The closed base end 76 may be placed at any point below the flange 74 thereby providing a variable interior volume 84. The closed base end 76 can generally be flat in its shape to provide a flat base surface for the interior volume 84. Otherwise, the closed base end 76 can be curved to provide at least a partially round bottom surface for the interior volume 84, more preferably, the closed base end is generally conical in shape to provide a tapered base surface for the inner volume 84. In addition, the closed base end 76 may be integrated with the side wall 62 or may be a discontinuous member. Preferably the closed base end 76 is integrally formed with the side wall 62. The open, rounded base end 80 includes the arch-shaped projection 86. The arch-shaped projection 86 provides the unit with a false bottom end. 80 arched with curves or at least partially rounded. The false bottom end provides better compatibility with chemical equipment and analytical or diagnostic test equipment or instruments that are designed to accommodate conventional, full-sized, round bottom blood collection tubes. The container 50 has an outer diameter A of approximately 13 millimeters, a length B of approximately 75 millimeters, measured from the flange 74 to the arched projection 86 of the open, rounded base end 80, and an interior volume 84 of approximately 1 to 3 milliliters. It is within the scope of this invention that the container 50 may have an external diameter of about 13 to about 16 milliliters, a length of about 75 to about 100 milliliters and an interior volume of about 1 to about 3 milliliters.

The invention, as shown in Figure 5, includes multiple components that are substantially identical to the components of Figures 3-4. Therefore, similar components that perform similar functions will be numbered identically to the components in Figures 3-4, except that a suffix "a" will be used to identify similar components in Figure 5. As illustrated in Figure 5, another embodiment of the invention is unit 100, wherein the annular skirt 78a extends from the closed base end 76a and the outer surface 74a to the rounded closed base end or false bottom 120. The rounded closed base end 120 is essentially rounded in shape or semi spherical. The unit 100 with the rounded closed base end or false bottom end is compatible with clinical equipment or instruments that are designed to house conventional, normal-sized round-bottom blood collection tubes. The invention, as shown in Figure 6, includes multiple components that are substantially identical to the components of Figures 3-4. Therefore, similar components that perform similar functions will be numbered identically as the components of Figures 3-4, except that a suffix "b" will be used to identify similar components in Figure 6.

As illustrated in Figure 6, another embodiment of the invention is unit 160 that includes a lid 180. The embodiment of Figure 6 can be vacuum or vacuum-free. When the unit 160 is vacuum, it has a full internal extraction pressure to be able to draw a sufficient amount of blood to substantially fill the interior volume 84b. The inner volume 84b is usually kept at a lower internal pressure than the atmospheric one so that when the blood collection probe penetrates through the lid by placing the inner volume 84b in communication with the circulatory system of a patient, the Less than atmospheric pressure of the inner volume 84b will draw blood from the patient into the tube. The unit 160 can be described as a full extraction blood collection tube because the internal pressure of the inner volume 84b is quite low to draw a volume of blood substantially equal to the volume of the inner volume 84b. The various embodiments of the present invention may be manufactured by known manufacturing methods including but not limited to injection molding or according to the following method: a. Providing an elongated tubular housing having the first and second opposite ends and a cylindrical wall therebetween defining a tubular interior; b. Place a solid separation within the tubular housing between the first and second ends; c. Heating a shaping tool or die that can be constructed of durable metal or conductive material at about 40 ° C to about 125 ° C and more preferably about 70 ° C; d. Inserting one of the ends of the tubular housing into the forming tool having an arc-shaped recess such as may be spherical; and. Apply a force of about 25 to about 400 pounds per tube for about 3 to about 7 seconds to the tubular housing to cause the end to soften and conform to or present the arc-shaped recess of the shaping tool; and f. Remove the tubular housing from the forming tool and cool to approximately 70 ° F (21 ° C) for approximately 10 seconds.

Claims (13)

# CLAIMS

1. A collection container unit consisting of: an elongated tubular housing having the first and second opposite ends and a cylindrical wall therebetween defining a tubular interior; and a solid separation placed inside the * accommodation between the first and second ends; The housing defines a volume for the collection of a sample and this between the first end and the spacing, the second end being reconfigured in at least one partially arcuate shape to provide the sample collection tube with at least one partially rounded end .

The unit of claim 1, wherein the first end is open to an interior portion of the housing and the second end is closed to define a 20 completely rounded end.

The unit of claim 1, wherein the spacing is integrated with the housing and has arcuate shape to provide the volume for collection of the samples with at least one base portion 25 partially rounded.

4. The unit of claim 1, wherein the separation is conical in shape.

The unit of claim 1, wherein the housing is a thermoplastic polymer.

6. The unit of claim 1, wherein the housing comprises an external diameter, a length and an internal volume, wherein the external diameter is approximately 13 to approximately 16 millimeters, the * length is from about 75 to about 100 10 millimeters and the internal volume is from about 1 to about 3 milliliters.

7. A method for providing a collection container unit with an arc-shaped end consisting of: providing an elongate tubular housing having the first and second opposite ends and «• a cylindrical wall between these defining a tubular interior; providing a solid separation within the housing between the first and second ends; and reconfiguring one of the ends in at least one partially arched shape.

The method of claim 11, wherein the reconfiguration step further includes: # inserting one of the ends into a shaping tool having an arc-shaped recess; and apply a force in the housing to make one of the ends conform to the shape of the recess in the form of 5 arch.

The method of claim 8, wherein the forming tool is heated before inserting one of the ends therein. * 10.

The method of claim 9, wherein the forming tool is heated to a temperature from about 40 ° C to about 125 ° C.

The method of claim 10, wherein the force is applied at a pressure of about 25 15 to approximately 400 pounds per tube.

The method of claim 10, wherein the force is applied for a period of from about 3 to about 7 seconds.

13. The method of providing a collecting unit unit with an arc-shaped end consists of: forming an elongated tubular housing having the first and second opposite ends and a cylindrical wall therebetween defining a tubular interior; Place a solid separation within the housing between the first and second ends. inserting one end into a heated forming tool having an arc-shaped recess; and apply a force to the housing to make one end conform to the shape of the arc-shaped recess.